Trazodone
Generic name: trazodone hydrochloride · Brand names: Desyrel, Oleptro, Trialodine
Quick facts
Drug class
The label calls trazodone a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist, an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
Highlights, Indications and Usage
Verbatim
Trazodone hydrochloride tablets are a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (1).
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
11 Description
Verbatim
Trazodone hydrochloride is a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist, an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents.Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4, 3-a]pyridin-3(2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water.
Rx or otc
Value
Rx (prescription label with a boxed warning and a Medication Guide)
Source
DailyMed Apotex label
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Controlled schedule
Not a controlled substance, per the label.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
9.1 Controlled Substance
Verbatim
Trazodone hydrochloride tablets are not a controlled substance.
Forms and strengths
Scored tablets in 50 mg, 100 mg, 150 mg and 300 mg (Apotex label). Other labelers list different strengths.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
3 Dosage Forms and Strengths
Verbatim
Trazodone hydrochloride tablets, USP are available in the following strengths:
50 mg : white, round, biconvex, scored tablets. Engraved “APO” bisect “T50” on one side, other side plain.
100 mg: white, round, biconvex, scored tablets. Engraved “APO” bisect “T100” on one side, other side plain.
150 mg: white, oval, flat faced beveled-edge scored tablets with a full bisect and 2 partial trisects. Engraved “APO” bisect “T150” on one side, and “50 50 50” on the other side.
300 mg: white, oval, flat faced beveled-edge scored tablets with a full bisect and 2 partial trisects. Engraved “APO” bisect “T300” on one side, and “100 100 100” on the other side with the middle “100” perpendicular to the others.
50 mg : white, round, biconvex, scored tablets. Engraved “APO” bisect “T50” on one side, other side plain.
100 mg: white, round, biconvex, scored tablets. Engraved “APO” bisect “T100” on one side, other side plain.
150 mg: white, oval, flat faced beveled-edge scored tablets with a full bisect and 2 partial trisects. Engraved “APO” bisect “T150” on one side, and “50 50 50” on the other side.
300 mg: white, oval, flat faced beveled-edge scored tablets with a full bisect and 2 partial trisects. Engraved “APO” bisect “T300” on one side, and “100 100 100” on the other side with the middle “100” perpendicular to the others.
Generic available
Value
Yes. Trazodone hydrochloride tablets are sold as generic ANDA products by many labelers on DailyMed. The brands Desyrel and Oleptro are no longer on the market (MedlinePlus).
Source
DailyMed search and MedlinePlus Brand names
Url
https://medlineplus.gov/druginfo/meds/a681038.html
Common use one line
Treatment of major depressive disorder (MDD) in adults.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
1 Indications and Usage
Verbatim
Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
What it is used for
The label lists one use: major depressive disorder (MDD) in adults. MedlinePlus, a secondary source, adds that trazodone is also sometimes used for other conditions such as insomnia and anxiety. Those are not label indications.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
1 Indications and Usage
Verbatim
Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
Source
MedlinePlus trazodone (secondary, patient-level)
Url
https://medlineplus.gov/druginfo/meds/a681038.html
Section
Other uses for this medicine
Verbatim
Trazodone is also sometimes used to treat insomnia and schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions); anxiety (excessive worry). Trazodone is also sometimes used to control abnormal, uncontrollable movements that may be experienced as side effects of other medications and for the management of alcohol dependence. Talk to your doctor about the possible risks of using this medication for your condition.
How it works
The label says how trazodone works as an antidepressant is not fully understood. It is thought to be related to enhancing serotonin activity in the CNS. It is both a selective serotonin reuptake inhibitor (SSRI) and a 5HT2 receptor antagonist.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
12.1 Mechanism of Action
Verbatim
The mechanism of trazodone’s antidepressant action is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS. Trazodone is both a selective serotonin reuptake inhibitor (SSRI) and a 5HT2 receptor antagonist and the net result of this action on serotonergic transmission and its role in trazodone’s antidepressant effect is unknown.
Dosage: adults
Label dosing: start at 150 mg/day in divided doses, then raise by 50 mg/day every 3 to 4 days. Outpatients usually should not exceed 400 mg/day in divided doses. Inpatients may be given up to 600 mg/day. Take it shortly after a meal or light snack. Tablets can be swallowed whole or split along the score line. Leave at least 14 days between an MAOI and trazodone in either direction.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
2.1 Dose Selection
Verbatim
An initial dose of 150 mg/day in divided doses is suggested. The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage.
The dose may be increased by 50 mg/day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses.
Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.
The dose may be increased by 50 mg/day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses.
Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
2.2 Important Administration Instructions
Verbatim
Trazodone hydrochloride tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line.
Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.
Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
2.4 Switching to or from Monoamine Oxidase Inhibitor Antidepressant
Verbatim
At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of trazodone hydrochloride tablets. In addition, at least 14 days must elapse after stopping trazodone hydrochloride tablets before starting an MAOI antidepressant [see Contraindications (4), Warnings and Precautions (5.2)].
Dosage: children
Trazodone tablets are not approved for use in pediatric patients. Safety and effectiveness in children have not been established. The Medication Guide says it is not known if trazodone is safe and effective in children.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
Boxed Warning
Verbatim
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. Trazodone hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)].
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
8.4 Pediatric Use
Verbatim
Safety and effectiveness in the pediatric population have not been established. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning, Warnings and Precautions (5.1)].
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
Medication Guide
Verbatim
It is not known if trazodone is safe and effective in children.
Dosage adjustments
Drug interaction caps
With a strong CYP3A4 inhibitor, consider reducing the trazodone dose based on tolerability. With a strong CYP3A4 inducer, consider increasing the dose based on response.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
2.5 Dosage Recommendations for Concomitant Use with Strong CYP3A4 Inhibitors or Inducers
Verbatim
Coadministration with Strong CYP3A4 Inhibitors
Consider reducing trazodone dose based on tolerability when trazodone is coadministered with a strong CYP3A4 inhibitor [see Drug Interactions (7.1)].
Coadministration with Strong CYP3A4 Inducers
Consider increasing trazodone dose based on therapeutic response when trazodone is coadministered with a strong CYP3A4 inducer [see Drug Interactions (7.1)].
Consider reducing trazodone dose based on tolerability when trazodone is coadministered with a strong CYP3A4 inhibitor [see Drug Interactions (7.1)].
Coadministration with Strong CYP3A4 Inducers
Consider increasing trazodone dose based on therapeutic response when trazodone is coadministered with a strong CYP3A4 inducer [see Drug Interactions (7.1)].
Kidney
Trazodone has not been studied in people with kidney impairment. The label says to use it with caution.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
8.6 Renal Impairment
Verbatim
Trazodone has not been studied in patients with renal impairment. Trazodone should be used with caution in this population.
Liver
Trazodone has not been studied in people with liver impairment. The label says to use it with caution.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
8.7 Hepatic Impairment
Verbatim
Trazodone has not been studied in patients with hepatic impairment. Trazodone should be used with caution in this population.
Elderly
Experience in older adults is limited, so use it with caution. Older adults may be at greater risk of low sodium (hyponatremia) with serotonergic antidepressants.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
8.5 Geriatric Use
Verbatim
Reported clinical literature and experience with trazodone has not identified differences in responses between elderly and younger patients. However, as experience in the elderly with trazodone hydrochloride is limited, it should be used with caution in geriatric patients.
Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.11)].
Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.11)].
Discontinuation
Reduce the dose gradually rather than stopping abruptly whenever possible.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
2.6 Discontinuation of Treatment with Trazodone Hydrochloride Tablets
Verbatim
Adverse reactions may occur upon discontinuation of trazodone hydrochloride tablets [See Warnings and Precautions (5.8)]. Gradually reduce the dosage rather than stopping trazodone hydrochloride tablets abruptly whenever possible.
Missed dose
MedlinePlus says to take a missed dose as soon as you remember. If it is almost time for the next dose, skip the missed one. Do not take a double dose. The Apotex label and Medication Guide have no missed-dose instruction.
Confidence
medium
Source text (exact source wording)
Source
MedlinePlus trazodone (secondary, patient-level)
Url
https://medlineplus.gov/druginfo/meds/a681038.html
Section
What should I do if I forget a dose?
Verbatim
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Overdose
The label says there is no specific antidote for trazodone overdose. The most severe reactions reported with trazodone alone were priapism, respiratory arrest, seizures, ECG changes including QT prolongation, and SIADH. Drowsiness and vomiting were reported most often. Call poison control at 1-800-222-1222. MedlinePlus says to call emergency services at 911 if the person has collapsed, had a seizure, has trouble breathing, or cannot be awakened.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
10 Overdosage
Verbatim
Death from overdose has occurred in patients ingesting trazodone and other CNS depressant drugs concurrently (alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or meprobamate).
The most severe reactions reported to have occurred with overdose of trazodone alone have been priapism, respiratory arrest, seizures, ECG changes, including QT prolongation, and syndrome of inappropriate antidiuretic hormone secretion (SIADH). The reactions reported most frequently have been drowsiness and vomiting. Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions.
There is no specific antidote for trazodone hydrochloride overdose.
In managing overdosage, consider the possibility of multiple drug involvement. For current information on the management of poisoning or overdose, contact a poison control center (1-800-222-1222 or www.poison.org).
The most severe reactions reported to have occurred with overdose of trazodone alone have been priapism, respiratory arrest, seizures, ECG changes, including QT prolongation, and syndrome of inappropriate antidiuretic hormone secretion (SIADH). The reactions reported most frequently have been drowsiness and vomiting. Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions.
There is no specific antidote for trazodone hydrochloride overdose.
In managing overdosage, consider the possibility of multiple drug involvement. For current information on the management of poisoning or overdose, contact a poison control center (1-800-222-1222 or www.poison.org).
Source
MedlinePlus trazodone (secondary, patient-level)
Url
https://medlineplus.gov/druginfo/meds/a681038.html
Section
In case of emergency/overdose
Verbatim
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include:
vomiting
drowsiness
changes in heartbeat
seizures
difficulty breathing
painful erection that does not go away
Symptoms of overdose may include:
vomiting
drowsiness
changes in heartbeat
seizures
difficulty breathing
painful erection that does not go away
Storage
Store at 20°C to 25°C (68°F to 77°F), with excursions permitted from 15°C to 30°C (59°F to 86°F). Use a tight, light-resistant container and keep it out of the reach of children. Storage details can differ by labeler.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
16 How Supplied/Storage and Handling
Verbatim
Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container.
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
Medication Guide
Verbatim
How should I store trazodone hydrochloride tablets?
Store trazodone hydrochloride tablets between 20°C to 25°C (68°F to 77°F).
Keep in tight container
Keep out of the light
Safely throw away medicine that is out of date or no longer needed.
Keep trazodone hydrochloride tablets and all medicines out of the reach of children.
Store trazodone hydrochloride tablets between 20°C to 25°C (68°F to 77°F).
Keep in tight container
Keep out of the light
Safely throw away medicine that is out of date or no longer needed.
Keep trazodone hydrochloride tablets and all medicines out of the reach of children.
Source
MedlinePlus trazodone (secondary, patient-level)
Url
https://medlineplus.gov/druginfo/meds/a681038.html
Section
Storage and disposal
Verbatim
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom).
Boxed warning
Antidepressants raised the risk of suicidal thoughts and behaviors in children and young adults in short-term studies. Everyone taking an antidepressant should be watched closely for worsening and for new suicidal thoughts or behaviors. Trazodone tablets are not approved for children.
Verbatim complete
yes
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
Boxed Warning (full prescribing information)
Verbatim
WARNING: SUICIDAL THOUGHTS and BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. Trazodone hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)].
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. Trazodone hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)].
Contraindications
Do not use trazodone if you take, or stopped within 14 days, a monoamine oxidase inhibitor (MAOI), including linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
4 Contraindications
Verbatim
Trazodone hydrochloride tablets are contraindicated in:
Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7.1)].
Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7.1)].
Warnings and precautions
In pooled placebo-controlled trials, suicidal thoughts and behaviors were more common with antidepressants in people under 18 (14 additional patients per 1,000) and ages 18-24 (5 additional per 1,000). Risk was lower at 25-64 (1 fewer) and 65 and older (6 fewer). Watch for worsening, especially in the first few months and at dose changes.
Heading
5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
5.1
Verbatim
In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1.
No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide.
Table 1: Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients
Age Range (years) Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1,000 Patients Treated
Increases Compared to Placebo
<18 14 additional patients
18-24 5 additional patients
Decreases Compared to Placebo
25-64 1 fewer patient
≥65 6 fewer patients
It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression.
Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing trazodone hydrochloride tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide.
Table 1: Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients
Age Range (years) Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1,000 Patients Treated
Increases Compared to Placebo
<18 14 additional patients
18-24 5 additional patients
Decreases Compared to Placebo
25-64 1 fewer patient
≥65 6 fewer patients
It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression.
Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing trazodone hydrochloride tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
Trazodone can cause serotonin syndrome, a potentially life-threatening condition, especially with other serotonergic drugs or MAOIs, though it can occur alone. Signs include agitation, hallucinations, fast heartbeat, fever, tremor, rigidity, and nausea, vomiting or diarrhea. Stop trazodone and other serotonergic drugs and start supportive treatment if it occurs.
Heading
5.2 Serotonin Syndrome
Confidence
high
Source text (exact source wording)
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Section
5.2
Verbatim
Serotonin-norepinephrine reuptake inhibitors (SNRIs) and SSRIs, including trazodone, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications (4), Drug Interactions (7.1)]. Serotonin syndrome can also occur when these drugs are used alone.
Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
The concomitant use of trazodone with MAOIs is contraindicated. In addition, do not initiate trazodone in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection). If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking trazodone hydrochloride tablets, discontinue trazodone before initiating treatment with the MAOI [see Contraindications (4), Drug Interactions (7.1)].
Monitor all patients taking trazodone for the emergence of serotonin syndrome. Discontinue treatment with trazodone and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of trazodone with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.
Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
The concomitant use of trazodone with MAOIs is contraindicated. In addition, do not initiate trazodone in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection). If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking trazodone hydrochloride tablets, discontinue trazodone before initiating treatment with the MAOI [see Contraindications (4), Drug Interactions (7.1)].
Monitor all patients taking trazodone for the emergence of serotonin syndrome. Discontinue treatment with trazodone and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of trazodone with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.
Trazodone prolongs the QT/QTc interval and may be arrhythmogenic in people with heart disease. Torsade de pointes was reported at doses of 100 mg or less. Avoid in known QT prolongation, a history of arrhythmias, and with other QT-prolonging drugs or CYP3A4 inhibitors. Not recommended during early recovery from a heart attack.
Heading
5.3 Cardiac Arrhythmias
Confidence
high
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Section
5.3
Verbatim
Clinical studies indicate that trazodone hydrochloride may be arrhythmogenic in patients with preexisting cardiac disease. Arrhythmias identified include isolated PVCs, ventricular couplets, tachycardia with syncope, and torsade de pointes. Postmarketing events, including torsade de pointes have been reported at doses of 100 mg or less with the immediate-release form of trazodone. Trazodone should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. Trazodone is not recommended for use during the initial recovery phase of myocardial infarction. Caution should be used when administering trazodone to patients with cardiac disease and such patients should be closely monitored, since antidepressant drugs (including trazodone) may cause cardiac arrhythmias [see Adverse Reactions (6.2)].
Trazodone prolongs the QT/QTc interval. The use of trazodone should be avoided in patients with known QT prolongation or in combination with other drugs that are inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, voriconazole), or known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin). Concomitant administration of drugs may increase the risk of cardiac arrhythmia [see Drug Interactions (7.1)].
Trazodone prolongs the QT/QTc interval. The use of trazodone should be avoided in patients with known QT prolongation or in combination with other drugs that are inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, voriconazole), or known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin). Concomitant administration of drugs may increase the risk of cardiac arrhythmia [see Drug Interactions (7.1)].
Low blood pressure, including on standing, and fainting have been reported. An antihypertensive dose may need to be reduced.
Heading
5.4 Orthostatic Hypotension and Syncope
Confidence
high
Source text (exact source wording)
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Section
5.4
Verbatim
Hypotension, including orthostatic hypotension and syncope has been reported in patients receiving trazodone hydrochloride. Concomitant use with an antihypertensive may require a reduction in the dose of the antihypertensive drug.
Trazodone increases the risk of bleeding events, and aspirin, NSAIDs, other antiplatelet drugs, warfarin and other anticoagulants may add to this. Monitor coagulation indices for patients on warfarin.
Heading
5.5 Increased Risk of Bleeding
Confidence
high
Source text (exact source wording)
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Section
5.5
Verbatim
Drugs that interfere with serotonin reuptake inhibition, including trazodone, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages.
Inform patients about the risk of bleeding associated with the concomitant use of trazodone and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor coagulation indices when initiating, titrating, or discontinuing trazodone.
Inform patients about the risk of bleeding associated with the concomitant use of trazodone and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor coagulation indices when initiating, titrating, or discontinuing trazodone.
Priapism (a painful erection lasting more than 6 hours) has been reported. A man with an erection lasting more than 4 hours, painful or not, should stop the drug and get emergency medical attention. Use caution with sickle cell anemia, multiple myeloma, leukemia, or penile deformity.
Heading
5.6 Priapism
Confidence
high
Source text (exact source wording)
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Section
5.6
Verbatim
Cases of priapism (painful erections greater than 6 hours in duration) have been reported in men receiving trazodone. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Men who have an erection lasting greater than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention [see Adverse Reactions (6.2), Overdosage (10)].
Trazodone should be used with caution in men who have conditions that might predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease).
Trazodone should be used with caution in men who have conditions that might predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease).
Trazodone may precipitate a mixed or manic episode in people with bipolar disorder. Screen for personal or family history of bipolar disorder, mania, or hypomania before starting.
Heading
5.7 Activation of Mania or Hypomania
Confidence
high
Source text (exact source wording)
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Section
5.7
Verbatim
In patients with bipolar disorder, treating a depressive episode with trazodone or another antidepressant may precipitate a mixed/manic episode. Activation of mania/hypomania has been reported in a small proportion of patients with major affective disorder who were treated with antidepressants. Prior to initiating treatment with trazodone, screen patients for any personal or family history of bipolar disorder, mania, or hypomania [see Dosage and Administration (2.3)].
Stopping abruptly can cause nausea, sweating, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, insomnia, tinnitus and seizures. A gradual dose reduction is recommended.
Heading
5.8 Discontinuation Syndrome
Confidence
high
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Section
5.8
Verbatim
Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [See Dosage and Administration (2.6)].
Trazodone may cause drowsiness or sedation and impair hazardous tasks. Be cautious with machinery and driving until you know how it affects you.
Heading
5.9 Potential for Cognitive and Motor Impairment
Confidence
high
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Section
5.9
Verbatim
Trazodone hydrochloride tablets may cause somnolence or sedation and may impair the mental and/or physical ability required for the performance of potentially hazardous tasks. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely.
Pupil dilation from antidepressants may trigger an angle-closure attack in people with anatomically narrow angles. Avoid use in people with untreated anatomically narrow angles.
Heading
5.10 Angle-Closure Glaucoma
Confidence
high
Source text (exact source wording)
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Section
5.10
Verbatim
The pupillary dilation that occurs following use of many antidepressant drugs including trazodone hydrochloride may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including trazodone, in patients with untreated anatomically narrow angles.
Low blood sodium may occur, sometimes below 110 mmol/L, usually from SIADH. Older adults, people on diuretics, and those who are volume-depleted are at greater risk. Stop trazodone in symptomatic hyponatremia.
Heading
5.11 Hyponatremia
Confidence
high
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Section
5.11
Verbatim
Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including trazodone. Cases with serum sodium lower than 110 mmol/L have been reported. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
In patients with symptomatic hyponatremia, discontinue trazodone and institute appropriate medical intervention. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs and SNRIs [see Use in Specific Populations (8.5)].
In patients with symptomatic hyponatremia, discontinue trazodone and institute appropriate medical intervention. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs and SNRIs [see Use in Specific Populations (8.5)].
Pregnancy and breastfeeding
Published studies over several decades have not identified drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies showed increased fetal resorption in rats and more congenital anomalies in rabbits at doses well above the human dose. Trazodone passes into human milk. Tell your provider if you are pregnant or plan to be. The National Pregnancy Registry for Antidepressants is at 1-844-405-6185.
Confidence
high
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Section
8.1 Pregnancy
Verbatim
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405- 6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/
Risk Summary
Published prospective cohort studies, case series, and case reports over several decades with trazodone use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data).
Trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 7.3 to 11 times the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m2 basis. There was also an increase in congenital anomalies in the rabbit at approximately 7.3 to 22 times the MRHD on a mg/m2 basis (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations
Disease-associated maternal and/or embryo-fetal risk
A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405- 6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/
Risk Summary
Published prospective cohort studies, case series, and case reports over several decades with trazodone use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data).
Trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 7.3 to 11 times the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m2 basis. There was also an increase in congenital anomalies in the rabbit at approximately 7.3 to 22 times the MRHD on a mg/m2 basis (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations
Disease-associated maternal and/or embryo-fetal risk
A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.
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Section
8.2 Lactation
Verbatim
Risk Summary
Data from published literature report the transfer of trazodone into human milk. There are no data on the effect of trazodone on milk production. Limited data from postmarketing reports have not identified and association of adverse effects on the breastfed child.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for trazodone and any potential adverse effects on the breastfed child from trazodone or from the underlying maternal condition.
Data from published literature report the transfer of trazodone into human milk. There are no data on the effect of trazodone on milk production. Limited data from postmarketing reports have not identified and association of adverse effects on the breastfed child.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for trazodone and any potential adverse effects on the breastfed child from trazodone or from the underlying maternal condition.
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Section
Medication Guide
Verbatim
are pregnant or plan to become pregnant. It is not known if trazodone hydrochloride tablets will harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take trazodone hydrochloride tablets.
If you become pregnant during treatment with trazodone hydrochloride tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185.
are breastfeeding or plan to breastfeed. Trazodone hydrochloride passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take trazodone hydrochloride tablets.
If you become pregnant during treatment with trazodone hydrochloride tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185.
are breastfeeding or plan to breastfeed. Trazodone hydrochloride passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take trazodone hydrochloride tablets.
Side effects
Common
The label's most common adverse reactions (5% or more and twice the placebo rate) are edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, and weight loss. The patient Medication Guide words its common list slightly differently (swelling, blurred vision, dizziness, sleepiness, tiredness, diarrhea, stuffy nose, weight loss).
Threshold
incidence ≥ 5% and twice that of placebo (label Highlights, Adverse Reactions)
Confidence
high
Source text (exact source wording)
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Section
Highlights, Adverse Reactions
Verbatim
Most common adverse reactions (incidence ≥ 5% and twice that of placebo) are: edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, weight loss (6).
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Section
Medication Guide
Verbatim
The most common side effects of trazodone hydrochloride tablets include:
swelling
blurred vision
dizziness
sleepiness
tiredness
diarrhea
stuffy nose
weight loss
swelling
blurred vision
dizziness
sleepiness
tiredness
diarrhea
stuffy nose
weight loss
Less common
Table 2 lists reactions seen in at least 2% of trazodone patients and more than with placebo. For example, dry mouth was 15% in inpatients and 34% in outpatients versus 8% and 20% on placebo, drowsiness 24% and 41% versus 6% and 20%, and dizziness or light-headedness 20% and 28% versus 5% and 15%. Rarer reactions under 2% are listed in the label.
Confidence
high
Source text (exact source wording)
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Section
6.1 Clinical Trials Experience (Table 2 and following paragraph)
Verbatim
Table 2: Common Adverse Reactions Occurring in ≥ 2% of Trazodone Hydrochloride Tablets-treated Patients and Greater than the Rate of Placebo-Treated Patients as Observed in Controlled Clinical Studies
Inpatients Outpatients
Trazodone Hydrochloride Tablets N=142 Placebo N=95 Trazodone Hydrochloride Tablets N=157 Placebo N=158
Allergic 3% 1% 7% 1%
Skin Condition/Edema
Autonomic
Blurred Vision 6% 4% 15% 4%
Constipation 7% 4% 8% 6%
Dry Mouth 15% 8% 34% 20%
Cardiovascular
Hypertension 20% 1% 1% *
Hypotension 7% 1% 4% 0
Syncope 3% 2% 5% 1%
CNS
Confusion 5% 0 6% 8%
Decreased Concentration 3% 2% 1% 0
Disorientation 2% 0 * 0
Dizziness/Light-Headedness 20% 5% 28% 15%
Drowsiness 24% 6% 41% 20%
Fatigue 11% 4% 6% 3%
Headache 10% 5% 20% 16%
Nervousness 15% 11% 6% 8%
Gastrointestinal
Abdominal/Gastric Disorder 4% 4% 6% 4%
Diarrhea 0 1% 5% 1%
Nausea/Vomiting 10% 1% 13% 10%
Musculoskeletal
Aches/Pains 6% 3% 5% 3%
Neurological
Incoordination 5% 0 2% *
Tremors 3% 1% 5% 4%
Other
Eyes Red/Tired/Itching 3% 0 0 0
Head Full-Heavy 3% 0 0 0
Malaise 3% 0 0 0
Nasal/Sinus Congestion 3% 0 6% 3%
Weight Gain 1% 0 5% 2%
Weight Loss * 3% 6% 3%
Other adverse reactions occurring at an incidence of <2% with the use of trazodone hydrochloride in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired memory, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, paresthesia, retrograde ejaculation, shortness of breath, and tachycardia/palpitations. Occasional sinus bradycardia has occurred in long-term studies.
Inpatients Outpatients
Trazodone Hydrochloride Tablets N=142 Placebo N=95 Trazodone Hydrochloride Tablets N=157 Placebo N=158
Allergic 3% 1% 7% 1%
Skin Condition/Edema
Autonomic
Blurred Vision 6% 4% 15% 4%
Constipation 7% 4% 8% 6%
Dry Mouth 15% 8% 34% 20%
Cardiovascular
Hypertension 20% 1% 1% *
Hypotension 7% 1% 4% 0
Syncope 3% 2% 5% 1%
CNS
Confusion 5% 0 6% 8%
Decreased Concentration 3% 2% 1% 0
Disorientation 2% 0 * 0
Dizziness/Light-Headedness 20% 5% 28% 15%
Drowsiness 24% 6% 41% 20%
Fatigue 11% 4% 6% 3%
Headache 10% 5% 20% 16%
Nervousness 15% 11% 6% 8%
Gastrointestinal
Abdominal/Gastric Disorder 4% 4% 6% 4%
Diarrhea 0 1% 5% 1%
Nausea/Vomiting 10% 1% 13% 10%
Musculoskeletal
Aches/Pains 6% 3% 5% 3%
Neurological
Incoordination 5% 0 2% *
Tremors 3% 1% 5% 4%
Other
Eyes Red/Tired/Itching 3% 0 0 0
Head Full-Heavy 3% 0 0 0
Malaise 3% 0 0 0
Nasal/Sinus Congestion 3% 0 6% 3%
Weight Gain 1% 0 5% 2%
Weight Loss * 3% 6% 3%
Other adverse reactions occurring at an incidence of <2% with the use of trazodone hydrochloride in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired memory, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, paresthesia, retrograde ejaculation, shortness of breath, and tachycardia/palpitations. Occasional sinus bradycardia has occurred in long-term studies.
Serious
Label
Postmarketing reports include hemolytic anemia, heart failure, conduction block, atrial fibrillation, cardiac arrest, QT prolongation, torsade de pointes, liver problems, seizures, tardive dyskinesia, priapism and urinary retention. The Medication Guide lists serotonin syndrome, irregular heartbeat (QT prolongation), low blood pressure, unusual bruising or bleeding, priapism, mania, withdrawal symptoms, eye problems and low sodium as serious effects to get medical help for.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
6.2 Postmarketing Experience
Verbatim
The following adverse reactions have been identified during post-approval use of trazodone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure:
Blood and lymphatic system disorders: hemolytic anemia, leukocytosis
Cardiac disorders: cardiospasm, congestive heart failure, conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, ventricular ectopic activity, including ventricular tachycardia and QT prolongation. Prolonged QT interval, torsade de pointes, and ventricular tachycardia have been reported at doses of 100 mg per day or less [see Warnings and Precautions (5.3)].
Endocrine disorders: inappropriate ADH syndrome
Eye disorders: diplopia
Gastrointestinal disorders: increased salivation, nausea/vomiting
General disorders and administration site conditions: chills, edema, unexplained death, weakness
Hepatobiliary disorders: cholestasis, jaundice, hyperbilirubinemia, liver enzyme alterations
Investigations: increased amylase
Metabolism and nutrition disorders: methemoglobinemia
Nervous system disorders: aphasia, ataxia, cerebrovascular accident, extrapyramidal symptoms, grand mal seizures, paresthesia, tardive dyskinesia, vertigo
Psychiatric disorders: abnormal dreams, agitation, anxiety, hallucinations, insomnia, paranoid reaction, psychosis, stupor
Renal and urinary disorders: urinary incontinence, urinary retention
Reproductive system and breast disorders: breast enlargement or engorgement, clitorism, lactation, priapism [see Warnings and Precautions (5.6)]
Respiratory, thoracic and mediastinal disorders: apnea
Skin and subcutaneous tissue disorders: alopecia, hirsutism, leukonychia, pruritus, psoriasis, rash, urticaria
Vascular disorders: vasodilation
Blood and lymphatic system disorders: hemolytic anemia, leukocytosis
Cardiac disorders: cardiospasm, congestive heart failure, conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, ventricular ectopic activity, including ventricular tachycardia and QT prolongation. Prolonged QT interval, torsade de pointes, and ventricular tachycardia have been reported at doses of 100 mg per day or less [see Warnings and Precautions (5.3)].
Endocrine disorders: inappropriate ADH syndrome
Eye disorders: diplopia
Gastrointestinal disorders: increased salivation, nausea/vomiting
General disorders and administration site conditions: chills, edema, unexplained death, weakness
Hepatobiliary disorders: cholestasis, jaundice, hyperbilirubinemia, liver enzyme alterations
Investigations: increased amylase
Metabolism and nutrition disorders: methemoglobinemia
Nervous system disorders: aphasia, ataxia, cerebrovascular accident, extrapyramidal symptoms, grand mal seizures, paresthesia, tardive dyskinesia, vertigo
Psychiatric disorders: abnormal dreams, agitation, anxiety, hallucinations, insomnia, paranoid reaction, psychosis, stupor
Renal and urinary disorders: urinary incontinence, urinary retention
Reproductive system and breast disorders: breast enlargement or engorgement, clitorism, lactation, priapism [see Warnings and Precautions (5.6)]
Respiratory, thoracic and mediastinal disorders: apnea
Skin and subcutaneous tissue disorders: alopecia, hirsutism, leukonychia, pruritus, psoriasis, rash, urticaria
Vascular disorders: vasodilation
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
Medication Guide
Verbatim
What are the possible side effects of trazodone hydrochloride tablets?
Trazodone hydrochloride tablets can cause serious side effects or death, including:
See “What is the most important information I should know about trazodone hydrochloride tablets?”
Serotonin syndrome. Symptoms of serotonin syndrome include: agitation, hallucinations, problems with coordination, fast heartbeat, tight muscles, trouble walking, sweating, fever, nausea, vomiting, and diarrhea.
Irregular or fast heartbeat or faint (QT prolongation)
Low blood pressure. You feel dizzy or faint when you change positions (go from sitting to standing)
Unusual bruising or bleeding
Erection lasting for more than 6 hours (priapism)
Feeling high or in a very good mood, then becoming irritable, or having too much energy, feeling like you have to keep talking or do not sleep (mania).
Withdrawal symptoms. Symptoms of withdrawal can include anxiety, agitation, and sleep problems. Do not stop taking trazodone hydrochloride tablets without talking to your healthcare provider.
Visual problems.
eye pain
changes in vision
swelling or redness in or around the eye
Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
Low sodium in your blood (hyponatremia). Symptoms of hyponatremia include: headache, feeling weak, feeling confused, trouble concentrating, memory problems and feeling unsteady when you walk.
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of trazodone hydrochloride tablets include:
swelling
blurred vision
dizziness
sleepiness
tiredness
diarrhea
stuffy nose
weight loss
These are not all the possible side effects of trazodone hydrochloride tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Trazodone hydrochloride tablets can cause serious side effects or death, including:
See “What is the most important information I should know about trazodone hydrochloride tablets?”
Serotonin syndrome. Symptoms of serotonin syndrome include: agitation, hallucinations, problems with coordination, fast heartbeat, tight muscles, trouble walking, sweating, fever, nausea, vomiting, and diarrhea.
Irregular or fast heartbeat or faint (QT prolongation)
Low blood pressure. You feel dizzy or faint when you change positions (go from sitting to standing)
Unusual bruising or bleeding
Erection lasting for more than 6 hours (priapism)
Feeling high or in a very good mood, then becoming irritable, or having too much energy, feeling like you have to keep talking or do not sleep (mania).
Withdrawal symptoms. Symptoms of withdrawal can include anxiety, agitation, and sleep problems. Do not stop taking trazodone hydrochloride tablets without talking to your healthcare provider.
Visual problems.
eye pain
changes in vision
swelling or redness in or around the eye
Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
Low sodium in your blood (hyponatremia). Symptoms of hyponatremia include: headache, feeling weak, feeling confused, trouble concentrating, memory problems and feeling unsteady when you walk.
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of trazodone hydrochloride tablets include:
swelling
blurred vision
dizziness
sleepiness
tiredness
diarrhea
stuffy nose
weight loss
These are not all the possible side effects of trazodone hydrochloride tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Medlineplus
MedlinePlus (secondary source) says to call your doctor or get emergency treatment for chest pain, shortness of breath, fainting, a fast or irregular heartbeat, seizures, unusual bruising or bleeding, or an erection lasting more than 6 hours.
Confidence
medium
Source text (exact source wording)
Source
MedlinePlus trazodone (secondary, patient-level)
Url
https://medlineplus.gov/druginfo/meds/a681038.html
Section
What side effects can this medication cause?
Verbatim
Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:
chest pain, shortness of breath, dizziness, fainting
fast, pounding, or irregular heartbeat
loss of consciousness (coma)
fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness or twitching, agitation, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
seizures
unusual bruising or bleeding
erection lasting more than 6 hours
headache
headache, unsteadiness, problems with thinking, concentration, or memory
problems with coordination
chest pain, shortness of breath, dizziness, fainting
fast, pounding, or irregular heartbeat
loss of consciousness (coma)
fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness or twitching, agitation, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
seizures
unusual bruising or bleeding
erection lasting more than 6 hours
headache
headache, unsteadiness, problems with thinking, concentration, or memory
problems with coordination
Led to discontinuation
Note
The Apotex label does not state a discontinuation rate in the sections captured (6.1 has Table 2 only).
Confidence
low
Medlineplus common
MedlinePlus (secondary) lists diarrhea, changes in appetite or weight, weakness or tiredness, sexual problems, stuffy nose, and swelling of the hands, feet or legs as side effects to report if severe or lasting.
Confidence
medium
Source text (exact source wording)
Source
MedlinePlus trazodone (secondary, patient-level)
Url
https://medlineplus.gov/druginfo/meds/a681038.html
Section
What side effects can this medication cause?
Verbatim
Trazodone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
diarrhea
changes in appetite or weight
weakness or tiredness
sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm
stuffy nose
swelling of the hands or feet or legs
diarrhea
changes in appetite or weight
weakness or tiredness
sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm
stuffy nose
swelling of the hands or feet or legs
Interactions
Drugs
The label lists clinically important interactions with MAOIs (contraindicated), other serotonergic drugs, antiplatelets and anticoagulants (including warfarin), strong CYP3A4 inhibitors (consider a lower trazodone dose), strong CYP3A4 inducers (may need a higher dose), digoxin and phenytoin (levels can rise), CNS depressants including alcohol and barbiturates, and QT-prolonging drugs.
Name
All label-listed interactions (Table 3)
Section
7.1
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
7.1 Table 3
Verbatim
Table 3: Clinically Important Drug Interactions with Trazodone Hydrochloride Tablets
Monoamine Oxidase Inhibitors (MAOIs)
Clinical Impact: The concomitant use of MAOIs and serotonergic drugs including trazodone increases the risk of serotonin syndrome.
Intervention: Trazodone is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Contraindications (4), Dosage and Administration (2.3, 2.4), and Warnings and Precautions (5.2)].
Examples: isocarboxazid, moclobemide, phenelzine, selegiline, tranylcypromine
Other Serotonergic Drugs
Clinical Impact: The concomitant use of serotonergic drugs including trazodone and other serotonergic drugs increases the risk of serotonin syndrome.
Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during trazodone initiation. If serotonin syndrome occurs, consider discontinuation of trazodone and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2)].
Examples: triptans, antidepressants (tricyclic and serotonin uptake inhibitors), fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort
Antiplatelet Agents and Anticoagulants
Clinical Impact: Serotonin release by platelets plays an important role in hemostasis. The concurrent use of an antiplatelet agent or anticoagulant with trazodone may potentiate the risk of bleeding.
Intervention: Inform patients of the increased risk of bleeding with the concomitant use of trazodone and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio (INR) when initiating or discontinuing trazodone [see Warnings and Precautions (5.5)].
Examples: warfarin, rivaroxaban, dabigatran, clopidogrel
Strong CYP3A4 Inhibitors
Clinical Impact: The concomitant use of trazodone and strong CYP3A4 inhibitors increased the exposure of trazodone compared to the use of trazodone alone.
Intervention: If trazodone is used with a potent CYP3A4 inhibitor, the risk of adverse reactions, including cardiac arrhythmias, may be increased and a lower dose of trazodone should be considered [see Dosage and Administration (2.5), Warnings and Precautions (5.3)].
Examples: itraconazole, ketoconazole, clarithromycin, indinavir
Strong CYP3A4 Inducers
Clinical Impact: The concomitant use of trazodone and strong CYP3A4 inducers decreased the exposure of trazodone compared to the use of trazodone alone.
Intervention: Patients should be closely monitored to see if there is a need for an increased dose of trazodone when taking CYP3A4 inducers [see Dosage and Administration (2.5)].
Examples: rifampin, carbamazepine, phenytoin, St. John’s wort
Digoxin and Phenytoin
Clinical Impact: Digoxin and phenytoin are narrow therapeutic index drugs. Concomitant use of trazodone can increase digoxin or phenytoin concentrations.
Intervention: Measure serum digoxin or phenytoin concentrations before initiating concomitant use of trazodone. Continue monitoring and reduce digoxin or phenytoin dose as necessary.
Examples: digoxin, phenytoin
Central Nervous System (CNS) Depressants
Clinical Impact: Trazodone may enhance the response to CNS depressants.
Intervention: Patients should be counseled that trazodone may enhance the response to alcohol, barbiturates, and other CNS depressants.
Examples: alcohol, barbiturates
QT Interval Prolongation
Clinical Impact: Concomitant use of drugs that prolong the QT interval may add to the QT effects of trazodone and increase the risk of cardiac arrhythmia.
Intervention: Avoid the use of trazodone in combination with other drugs known to prolong QTc [see Warnings and Precautions (5.3)].
Examples: Class 1A antiarrhythmics: quinidine, procainamide, disopyramide; Class 3 antiarrhythmics: amiodarone, sotalol; Antipsychotics: ziprasidone, chlorpromazine, thioridazine; Antibiotics: gatifloxacin
Monoamine Oxidase Inhibitors (MAOIs)
Clinical Impact: The concomitant use of MAOIs and serotonergic drugs including trazodone increases the risk of serotonin syndrome.
Intervention: Trazodone is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Contraindications (4), Dosage and Administration (2.3, 2.4), and Warnings and Precautions (5.2)].
Examples: isocarboxazid, moclobemide, phenelzine, selegiline, tranylcypromine
Other Serotonergic Drugs
Clinical Impact: The concomitant use of serotonergic drugs including trazodone and other serotonergic drugs increases the risk of serotonin syndrome.
Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during trazodone initiation. If serotonin syndrome occurs, consider discontinuation of trazodone and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2)].
Examples: triptans, antidepressants (tricyclic and serotonin uptake inhibitors), fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort
Antiplatelet Agents and Anticoagulants
Clinical Impact: Serotonin release by platelets plays an important role in hemostasis. The concurrent use of an antiplatelet agent or anticoagulant with trazodone may potentiate the risk of bleeding.
Intervention: Inform patients of the increased risk of bleeding with the concomitant use of trazodone and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio (INR) when initiating or discontinuing trazodone [see Warnings and Precautions (5.5)].
Examples: warfarin, rivaroxaban, dabigatran, clopidogrel
Strong CYP3A4 Inhibitors
Clinical Impact: The concomitant use of trazodone and strong CYP3A4 inhibitors increased the exposure of trazodone compared to the use of trazodone alone.
Intervention: If trazodone is used with a potent CYP3A4 inhibitor, the risk of adverse reactions, including cardiac arrhythmias, may be increased and a lower dose of trazodone should be considered [see Dosage and Administration (2.5), Warnings and Precautions (5.3)].
Examples: itraconazole, ketoconazole, clarithromycin, indinavir
Strong CYP3A4 Inducers
Clinical Impact: The concomitant use of trazodone and strong CYP3A4 inducers decreased the exposure of trazodone compared to the use of trazodone alone.
Intervention: Patients should be closely monitored to see if there is a need for an increased dose of trazodone when taking CYP3A4 inducers [see Dosage and Administration (2.5)].
Examples: rifampin, carbamazepine, phenytoin, St. John’s wort
Digoxin and Phenytoin
Clinical Impact: Digoxin and phenytoin are narrow therapeutic index drugs. Concomitant use of trazodone can increase digoxin or phenytoin concentrations.
Intervention: Measure serum digoxin or phenytoin concentrations before initiating concomitant use of trazodone. Continue monitoring and reduce digoxin or phenytoin dose as necessary.
Examples: digoxin, phenytoin
Central Nervous System (CNS) Depressants
Clinical Impact: Trazodone may enhance the response to CNS depressants.
Intervention: Patients should be counseled that trazodone may enhance the response to alcohol, barbiturates, and other CNS depressants.
Examples: alcohol, barbiturates
QT Interval Prolongation
Clinical Impact: Concomitant use of drugs that prolong the QT interval may add to the QT effects of trazodone and increase the risk of cardiac arrhythmia.
Intervention: Avoid the use of trazodone in combination with other drugs known to prolong QTc [see Warnings and Precautions (5.3)].
Examples: Class 1A antiarrhythmics: quinidine, procainamide, disopyramide; Class 3 antiarrhythmics: amiodarone, sotalol; Antipsychotics: ziprasidone, chlorpromazine, thioridazine; Antibiotics: gatifloxacin
The Medication Guide asks patients to tell their provider if they take triptans, mood, anxiety or psychosis medicines, tramadol, tryptophan or St. John's Wort, NSAIDs, aspirin, warfarin, phenytoin or diuretics.
Name
Medication Guide list
Section
Medication Guide
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
Medication Guide
Verbatim
Especially tell your healthcare provider if you take:
triptans used to treat migraine headache
medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, buspirone, or antipsychotics
tramadol
over-the-counter supplements such as tryptophan or St. John’s Wort
nonsteroidal anti-inflammatory drugs (NSAIDS)
aspirin
warfarin (Coumadin, Jantoven)
phenytoin (Mesantoin)
diuretics
triptans used to treat migraine headache
medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, buspirone, or antipsychotics
tramadol
over-the-counter supplements such as tryptophan or St. John’s Wort
nonsteroidal anti-inflammatory drugs (NSAIDS)
aspirin
warfarin (Coumadin, Jantoven)
phenytoin (Mesantoin)
diuretics
Food and alcohol
The Medication Guide says not to drink alcohol or take other medicines that make you sleepy or dizzy until you talk with your provider, because trazodone may make sleepiness or dizziness worse. MedlinePlus agrees that alcohol can make side effects worse.
Name
Alcohol
Section
Medication Guide; 7.1; MedlinePlus
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
Medication Guide
Verbatim
What should I avoid while taking trazodone hydrochloride tablets?
Do not drive, operate heavy machinery, or do other dangerous activities until you know how trazodone hydrochloride tablets affect you. Trazodone hydrochloride tablets can slow your thinking and motor skills.
Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking trazodone hydrochloride tablets until you talk with your healthcare provider. Trazodone hydrochloride tablets may make your sleepiness or dizziness worse if you take it with alcohol or other medicines that cause sleepiness or dizziness.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how trazodone hydrochloride tablets affect you. Trazodone hydrochloride tablets can slow your thinking and motor skills.
Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking trazodone hydrochloride tablets until you talk with your healthcare provider. Trazodone hydrochloride tablets may make your sleepiness or dizziness worse if you take it with alcohol or other medicines that cause sleepiness or dizziness.
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
7.1 Table 3 (CNS Depressants)
Verbatim
Clinical Impact: Trazodone may enhance the response to CNS depressants.
Intervention: Patients should be counseled that trazodone may enhance the response to alcohol, barbiturates, and other CNS depressants.
Intervention: Patients should be counseled that trazodone may enhance the response to alcohol, barbiturates, and other CNS depressants.
Source
MedlinePlus trazodone (secondary, patient-level)
Url
https://medlineplus.gov/druginfo/meds/a681038.html
Section
What special precautions should I follow?
Verbatim
ask your doctor about the safe use of alcoholic beverages while you are taking trazodone. Alcohol can make the side effects from trazodone worse.
MedlinePlus (secondary source) says to talk to your doctor about grapefruit and grapefruit juice. The Apotex label has no grapefruit statement.
Name
Grapefruit (MedlinePlus only)
Section
MedlinePlus
Confidence
medium
Source text (exact source wording)
Source
MedlinePlus trazodone (secondary, patient-level)
Url
https://medlineplus.gov/druginfo/meds/a681038.html
Section
Dietary instructions
Verbatim
What special dietary instructions should I follow?
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.
Take it shortly after a meal or light snack. Food can increase the amount absorbed and delay peak levels.
Name
Food (how to take)
Section
2.2; 12.3
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
2.2 Important Administration Instructions
Verbatim
Trazodone hydrochloride tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line.
Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.
Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
12.3 Pharmacokinetics (Absorption)
Verbatim
In humans, trazodone hydrochloride is absorbed after oral administration without selective localization in any tissue. When trazodone hydrochloride is taken shortly after ingestion of food, there may be an increase in the amount of drug absorbed, a decrease in maximum concentration and a lengthening in the time to maximum concentration. Peak plasma levels occur approximately one hour after dosing when trazodone hydrochloride is taken on an empty stomach or 2 hours after dosing when taken with food.
Patient tips
Label medication guide
Take it exactly as your provider says, shortly after a meal or light snack. Swallow whole or break in half along the score line; do not chew or crush. Tell your provider if you feel drowsy, since the dose or timing may change. Do not stop without talking to your provider. Do not drive or do dangerous activities until you know how it affects you. If you take too much, call poison control at 1-800-222-1222 or go to the nearest emergency room.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
Medication Guide
Verbatim
How should I take trazodone hydrochloride tablets?
Take trazodone hydrochloride tablets exactly as your healthcare provider tells you.
Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.
If you feel drowsy after taking trazodone hydrochloride tablets, talk to your healthcare provider. Your healthcare provider may change your dose or the time of day you take your trazodone hydrochloride tablets.
Do not stop taking trazodone hydrochloride tablets without talking to your healthcare provider.
Trazodone hydrochloride tablets should be swallowed whole or broken in half along the score line. Do not chew or crush trazodone hydrochloride tablets. Tell your healthcare provider if you cannot swallow trazodone either whole or as a half tablet.
If you take too much trazodone hydrochloride, call your healthcare provider, your Poison Control Center at 1-800-222-1222, or go to the nearest emergency room right away.
Take trazodone hydrochloride tablets exactly as your healthcare provider tells you.
Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.
If you feel drowsy after taking trazodone hydrochloride tablets, talk to your healthcare provider. Your healthcare provider may change your dose or the time of day you take your trazodone hydrochloride tablets.
Do not stop taking trazodone hydrochloride tablets without talking to your healthcare provider.
Trazodone hydrochloride tablets should be swallowed whole or broken in half along the score line. Do not chew or crush trazodone hydrochloride tablets. Tell your healthcare provider if you cannot swallow trazodone either whole or as a half tablet.
If you take too much trazodone hydrochloride, call your healthcare provider, your Poison Control Center at 1-800-222-1222, or go to the nearest emergency room right away.
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
Medication Guide
Verbatim
What should I avoid while taking trazodone hydrochloride tablets?
Do not drive, operate heavy machinery, or do other dangerous activities until you know how trazodone hydrochloride tablets affect you. Trazodone hydrochloride tablets can slow your thinking and motor skills.
Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking trazodone hydrochloride tablets until you talk with your healthcare provider. Trazodone hydrochloride tablets may make your sleepiness or dizziness worse if you take it with alcohol or other medicines that cause sleepiness or dizziness.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how trazodone hydrochloride tablets affect you. Trazodone hydrochloride tablets can slow your thinking and motor skills.
Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking trazodone hydrochloride tablets until you talk with your healthcare provider. Trazodone hydrochloride tablets may make your sleepiness or dizziness worse if you take it with alcohol or other medicines that cause sleepiness or dizziness.
Label counseling
The label tells providers to counsel on suicidality, taking it after a meal or light snack, serotonin syndrome, signs of mania, bleeding risk with aspirin, NSAIDs and anticoagulants, not stopping abruptly, telling providers about all medicines, and the pregnancy registry.
Confidence
high
Source text (exact source wording)
Source
DailyMed Apotex trazodone hydrochloride tablets label (printer-friendly page)
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Section
17 Patient Counseling Information
Verbatim
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Suicidal Thoughts and Behaviors
Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider [see Box Warning and Warnings and Precautions (5.1)].
Dosage and Administration
Advise patients that trazodone hydrochloride tablets should be taken shortly after a meal or light snack. Advise patients regarding the importance of following dosage titration instructions [see Dosage and Administration (2)].
Serotonin Syndrome
Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of trazodone with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2) and Drug Interactions (7)].
Activation of Mania/Hypomania
Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.7)].
Increased Risk of Bleeding
Inform patients about the concomitant use of trazodone with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use of drugs that interfere with serotonin reuptake and these medications has been associated with an increased risk of bleeding. Advise them to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions (5.5)].
Discontinuation Syndrome
Advise patients not to abruptly discontinue trazodone hydrochloride tablets and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when trazodone hydrochloride tablets is discontinued [see Warnings and Precautions (5.8)].
Concomitant Medications
Advise patients to inform their health care providers if they are taking, or plan to take any prescription or over-the-counter medications since there is a potential for interactions [see Drug Interactions (7.1)].
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with trazodone hydrochloride tablets. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to trazodone hydrochloride tablets during pregnancy [see Use in Special Populations (8.1)].
Suicidal Thoughts and Behaviors
Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider [see Box Warning and Warnings and Precautions (5.1)].
Dosage and Administration
Advise patients that trazodone hydrochloride tablets should be taken shortly after a meal or light snack. Advise patients regarding the importance of following dosage titration instructions [see Dosage and Administration (2)].
Serotonin Syndrome
Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of trazodone with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2) and Drug Interactions (7)].
Activation of Mania/Hypomania
Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.7)].
Increased Risk of Bleeding
Inform patients about the concomitant use of trazodone with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use of drugs that interfere with serotonin reuptake and these medications has been associated with an increased risk of bleeding. Advise them to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions (5.5)].
Discontinuation Syndrome
Advise patients not to abruptly discontinue trazodone hydrochloride tablets and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when trazodone hydrochloride tablets is discontinued [see Warnings and Precautions (5.8)].
Concomitant Medications
Advise patients to inform their health care providers if they are taking, or plan to take any prescription or over-the-counter medications since there is a potential for interactions [see Drug Interactions (7.1)].
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with trazodone hydrochloride tablets. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to trazodone hydrochloride tablets during pregnancy [see Use in Special Populations (8.1)].
Medlineplus
MedlinePlus (secondary) says it may take 2 weeks or longer to feel the full benefit, to keep taking it even if you feel well, to get out of bed slowly to avoid dizziness, and to call your doctor or get emergency care for eye pain, vision changes, or swelling or redness around the eye.
Confidence
medium
Source text (exact source wording)
Source
MedlinePlus trazodone (secondary, patient-level)
Url
https://medlineplus.gov/druginfo/meds/a681038.html
Section
How should this medicine be used?
Verbatim
Trazodone comes as a tablet to take by mouth. Take with a meal or light snack two or more times a day. Take it around the same time(s) every day.
Swallow the tablets whole or broken in half on the score mark.
Your doctor may start you on a low dose of trazodone and gradually increase your dose, not more than once every 3 to 4 days.
Trazodone controls depression, but does not cure it. It may take 2 weeks or longer before you feel the full benefit of trazodone. Continue to take trazodone even if you feel well.
Do not stop taking trazodone without talking to your doctor.
Swallow the tablets whole or broken in half on the score mark.
Your doctor may start you on a low dose of trazodone and gradually increase your dose, not more than once every 3 to 4 days.
Trazodone controls depression, but does not cure it. It may take 2 weeks or longer before you feel the full benefit of trazodone. Continue to take trazodone even if you feel well.
Do not stop taking trazodone without talking to your doctor.
Source
MedlinePlus trazodone (secondary, patient-level)
Url
https://medlineplus.gov/druginfo/meds/a681038.html
Section
Precautions (orthostatic)
Verbatim
you should know that trazodone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
Source
MedlinePlus trazodone (secondary, patient-level)
Url
https://medlineplus.gov/druginfo/meds/a681038.html
Section
Precautions (glaucoma)
Verbatim
you should know that trazodone may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.
Alternatives
Class
selective serotonin reuptake inhibitor and 5HT2 receptor antagonist (label section 11)
Indication
major depressive disorder in adults (label section 1)
Note
A sourced list of other drugs in this class was not obtained in this run. No drug is recommended here.
Confidence
low
Frequently asked questions
Question
What is trazodone used for?
Answer
The label lists major depressive disorder (MDD) in adults.
Source section
1 Indications and Usage
Source
DailyMed Apotex label
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Question
Should I take trazodone with food?
Answer
Yes. The label says tablets should be taken shortly after a meal or light snack.
Source section
2.2
Source
DailyMed Apotex label
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Question
What should I do if I miss a dose?
Answer
MedlinePlus says to take it as soon as you remember, unless it is almost time for the next dose, in which case skip it. Do not take a double dose. The label has no missed-dose instruction.
Source section
MedlinePlus: What should I do if I forget a dose?
Source
MedlinePlus (secondary)
Url
https://medlineplus.gov/druginfo/meds/a681038.html
Question
Can I drink alcohol on trazodone?
Answer
The Medication Guide says not to drink alcohol or take other medicines that make you sleepy or dizzy until you talk with your healthcare provider.
Source section
Medication Guide
Source
DailyMed Apotex label
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Question
What are the most common side effects?
Answer
The label lists edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, and weight loss (5% or more and twice placebo).
Source section
Highlights, Adverse Reactions
Source
DailyMed Apotex label
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Question
Is trazodone safe in pregnancy or while breastfeeding?
Answer
Published studies have not identified drug-associated risks of major birth defects or miscarriage. Trazodone passes into human milk. Talk to your provider before starting or stopping it.
Source section
8.1; 8.2
Source
DailyMed Apotex label
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Question
What should I not combine with trazodone?
Answer
MAOIs are contraindicated, including within 14 days either way. Other serotonergic drugs raise the risk of serotonin syndrome, and aspirin, NSAIDs and anticoagulants may raise bleeding risk.
Source section
4; 7.1
Source
DailyMed Apotex label
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Question
Can I stop trazodone suddenly?
Answer
No. The label recommends gradually reducing the dose. Stopping abruptly can cause withdrawal-type reactions.
Source section
2.6; 5.8
Source
DailyMed Apotex label
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Question
Is trazodone approved for children?
Answer
No. The label says it is not approved for pediatric patients.
Source section
Boxed Warning; 8.4
Source
DailyMed Apotex label
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Question
Is trazodone a controlled substance?
Answer
No. The label states it is not a controlled substance.
Source section
9.1
Source
DailyMed Apotex label
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85&type=display
Sources
- Trazodone Hydrochloride Tablets, Apotex Corp (CHOSEN generic label)
Set id: 71961ab1-951d-1493-f76c-2ff25cca2a85 · Label effective or revised date: Revised: 3/2026 (Highlights); Medication Guide: Revised: March 2026 · Dailymed version date: Updated March 24, 2026; version 22 published Mar 25, 2026 (from DailyMed listing; kept separate from the label Revised date) · Fetched at: 2026-11-02 · Sections used: Highlights, Boxed Warning, 1-8, 9.1, 10, 11, 12.1, 12.3, 16, 17, Medication Guide (verbatim, printer-friendly page) - ALTERNATE 1: Trazodone tablets, Oxford Pharmaceuticals, LLC
Set id: 283c8236-9776-44cb-b7b2-1024689de736 · Label effective or revised date: Revised: 3/2026 · Dailymed version date: published Jul 20, 2026 (listing) · Fetched at: 2026-11-02 · Sections used: date and strengths only (film-coated, 50 mg and 100 mg) - ALTERNATE 2: Trazodone tablets, Torrent Pharmaceuticals Limited
Set id: 1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7 · Label effective or revised date: Revised: 2/2026 · Dailymed version date: published Mar 05, 2026 (listing) · Fetched at: 2026-11-02 · Sections used: date only - MedlinePlus: Trazodone (secondary source)
Set id: n/a · Label effective or revised date: Last Revised - 10/15/2025 · Fetched at: 2026-11-02 · Sections used: Brand names, why prescribed, how used, other uses, precautions, diet, missed dose, side effects, storage, overdose (verbatim via get_page_text) - Drugs@FDA
Set id: n/a · Label effective or revised date: NOT FOUND · Fetched at: 2026-11-02 · Sections used: NOT FOUND: search page returned no result rows
Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug