Sertraline hydrochloride
Generic name: sertraline hydrochloride · Brand names: Zoloft
Quick facts
Drug class
Value
selective serotonin reuptake inhibitor (SSRI)
Source
MedlinePlus: 'Sertraline is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).' openFDA pharm_class_epc count for SERTRALINE HYDROCHLORIDE returned 'Nothing to count' (not used).
Url
https://medlineplus.gov/druginfo/meds/a697048.html
Label wording
Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT). (12.1)
Rx or otc
Rx (Medication Guide: 'prescription medicine')
Controlled schedule
Sertraline hydrochloride tablet contains sertraline, which is not a controlled substance. (9.1 Controlled Substance)
Forms and strengths
- 25 mg Tablets: Green colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D01' on the other side.
- 50 mg Tablets: Blue colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D02' on the other side.
- 100 mg Tablets: Yellow colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D03' on the other side. (3 Dosage Forms and Strengths)
Generic available
Value
Yes: this record is a generic label (Lupin)
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Common use one line
Treats depression, OCD, panic disorder, PTSD, social anxiety disorder and PMDD (Indications and Usage).
What it is used for
Sertraline treats major depressive disorder, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, social anxiety disorder and premenstrual dysphoric disorder.
Section
1 INDICATIONS AND USAGE
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]:
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Posttraumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Posttraumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
How it works
Sertraline raises serotonin activity in the brain by blocking the reuptake of serotonin into nerve cells.
Section
12.1 Mechanism of Action
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT).
Dosage: adults
Mdd ocd pd ptsd sad
Adults with depression or OCD start at 50 mg per day. Adults with panic disorder, PTSD or social anxiety disorder start at 25 mg per day. The usual range is 50 to 200 mg. If needed the dose can go up in 25 to 50 mg per day steps once a week, to a maximum of 200 mg per day.
Section
2.1 Dosage in Patients with MDD, OCD, PD, PTSD, and SAD
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
The recommended initial dosage and maximum sertraline hydrochloride dosage in patients with MDD, OCD, PD, PTSD, and SAD are displayed in Table 1 below. A dosage of 25 mg or 50 mg per day is the initial therapeutic dosage.
For adults and pediatric patients, subsequent dosages may be increased in case of an inadequate response in 25 to 50 mg per day increments once a week, depending on tolerability, up to a maximum of 200 mg per day. Given the 24-hour elimination half-life of sertraline hydrochloride, the recommended interval between dose changes is one week.
Table 1 (Adults): MDD Starting Dose 50 mg, Therapeutic Range 50 to 200 mg; OCD Starting Dose 50 mg; PD, PTSD, SAD Starting Dose 25 mg
For adults and pediatric patients, subsequent dosages may be increased in case of an inadequate response in 25 to 50 mg per day increments once a week, depending on tolerability, up to a maximum of 200 mg per day. Given the 24-hour elimination half-life of sertraline hydrochloride, the recommended interval between dose changes is one week.
Table 1 (Adults): MDD Starting Dose 50 mg, Therapeutic Range 50 to 200 mg; OCD Starting Dose 50 mg; PD, PTSD, SAD Starting Dose 25 mg
Pmdd
For PMDD the starting dose is 50 mg per day, taken every day of the cycle or only in the luteal phase starting 14 days before expected menstruation through the onset of menses. Continuous dosing can go up by 50 mg per cycle to 150 mg per day. Intermittent dosing can go up to 100 mg per day as described in the label.
Section
2.2 Dosage in Patients with PMDD
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
The recommended starting sertraline hydrochloride dosage in adult women with PMDD is 50 mg per day. Sertraline hydrochloride tablets may be administered either continuously (every day throughout the menstrual cycle) or intermittently (only during the luteal phase of the menstrual cycle, i.e., starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.
When dosing continuously, patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
When dosing intermittently, patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles) as follows: 50 mg per day during the first 3 days of dosing followed by 100 mg per day during the remaining days in the dosing cycle.
When dosing continuously, patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
When dosing intermittently, patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles) as follows: 50 mg per day during the first 3 days of dosing followed by 100 mg per day during the remaining days in the dosing cycle.
How to take label medguide
Take it exactly as prescribed. It may be taken with or without food. Your provider may adjust the dose.
Section
Medication Guide (part of the same Lupin label), How should I take sertraline hydrochloride tablets?
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Take sertraline hydrochloride tablets exactly as prescribed. Your healthcare provider may need to change the dose of sertraline hydrochloride tablets until it is the right dose for you.
Sertraline hydrochloride tablets may be taken with or without food.
Sertraline hydrochloride tablets may be taken with or without food.
Dosage: children
For children with OCD, ages 6 to 12 years start at 25 mg and ages 13 to 17 years start at 50 mg, with a range of 50 to 200 mg. Safety and effectiveness are established for OCD in ages 6 to 17. They are not established below the age of 6 or for other conditions in children.
Section
2.1 (Table 1, Pediatric Patients) and 8.4 Pediatric Use
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Pediatric Patients (Table 1): OCD (ages 6 to 12 years old) Starting Dose 25 mg, Therapeutic Range 50 to 200 mg; OCD (ages 13 to 17 years old) Starting Dose 50 mg.
8.4: The safety and efficacy of sertraline hydrochloride have been established in the treatment of OCD in pediatric patients aged 6 to 17 [See Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.2)]. Safety and effectiveness in pediatric patients in patients with OCD below the age of 6 have not been established. Safety and effectiveness have not been established in pediatric patients for indications other than OCD.
8.4: The safety and efficacy of sertraline hydrochloride have been established in the treatment of OCD in pediatric patients aged 6 to 17 [See Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.2)]. Safety and effectiveness in pediatric patients in patients with OCD below the age of 6 have not been established. Safety and effectiveness have not been established in pediatric patients for indications other than OCD.
Dosage adjustments
Drug interaction caps
The label gives no fixed dose cap. It advises lowering the dose of certain other medicines if needed (CYP2D6 drugs, phenytoin, protein-bound drugs), and monitoring.
Section
7.1 Clinically Significant Drug Interactions (Table 5)
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Drugs Metabolized by CYP2D6 - Intervention: Decrease the dosage of a CYP2D6 substrate if needed with concomitant sertraline hydrochloride use. Conversely, an increase in dosage of a CYP2D6 substrate may be needed if sertraline hydrochloride is discontinued.
Phenytoin - Intervention: Monitor phenytoin levels when initiating or titrating sertraline hydrochloride. Reduce phenytoin dosage if needed.
Drugs Highly Bound to Plasma Protein - Intervention: Monitor for adverse reactions and reduce dosage of sertraline hydrochloride or other protein-bound drugs as warranted.
Phenytoin - Intervention: Monitor phenytoin levels when initiating or titrating sertraline hydrochloride. Reduce phenytoin dosage if needed.
Drugs Highly Bound to Plasma Protein - Intervention: Monitor for adverse reactions and reduce dosage of sertraline hydrochloride or other protein-bound drugs as warranted.
Kidney
No dose change is needed for mild to severe kidney impairment.
Section
8.7 Renal Impairment
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
No dose adjustment is needed in patients with mild to severe renal impairment. Sertraline exposure does not appear to be affected by renal impairment [See Clinical Pharmacology (12.3)].
Liver
With mild liver impairment (Child Pugh scores 5 or 6) the starting dose and range are half the usual. Use is not recommended with moderate (Child Pugh scores 7 to 9) or severe (Child Pugh scores 10 to 15) liver impairment.
Section
2.4 Dosage Modifications in Patients with Hepatic Impairment
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Both the recommended starting dosage and therapeutic range in patients with mild hepatic impairment (Child Pugh scores 5 or 6) are half the recommended daily dosage [See Dosage and Administration (2.1, 2.2)]. The use of sertraline hydrochloride tablets in patients with moderate (Child Pugh scores 7 to 9) or severe hepatic impairment (Child Pugh scores 10 to 15) is not recommended [See Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
Elderly
The label saw no overall difference in safety or effectiveness in older patients. Dose selection should be conservative, usually starting at the low end of the range. Older patients may be at greater risk of low sodium.
Section
8.5 Geriatric Use
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be conservative, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Maoi switching
Wait at least 14 days between stopping an MAOI and starting sertraline, and at least 14 days after stopping sertraline before starting an MAOI.
Section
2.5 Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of sertraline hydrochloride tablets. In addition, at least 14 days must elapse after stopping sertraline hydrochloride tablets before starting an MAOI antidepressant [See Contraindications (4), Warnings and Precautions (5.2)].
Missed dose
Label medication guide
Take the missed dose when you remember. If it is almost time for the next dose, skip it. Never take two doses at the same time.
Section
Medication Guide (part of the same Lupin label), How should I take sertraline hydrochloride tablets?
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
If you miss a dose of sertraline hydrochloride tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of sertraline hydrochloride tablets at the same time.
Medlineplus
Same advice as the label.
Section
What should I do if I forget a dose?
Source
MedlinePlus
Source url
https://medlineplus.gov/druginfo/meds/a697048.html
Source text (exact source wording)
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
Overdose can cause seizures (which may be delayed), coma, heart effects including QRS and QTc prolongation, and serotonin syndrome. Activated charcoal should be considered for people who arrive early. The label lists the Poison Center number as 1-800-221-2222; see conflicts.
Section
10 OVERDOSAGE
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Poison control
Source
MedlinePlus
Source url
https://medlineplus.gov/druginfo/meds/a697048.html
Source text (exact source wording)
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. Symptoms of overdose may include the following: agitation, hallucinations, fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea; seizures; coma (loss of consciousness); rapid, irregular, or pounding heartbeat
Source text (exact source wording)
The following have been reported with sertraline tablet overdosage:
Seizures, which may be delayed, and altered mental status including coma.
Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol.
Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk).
Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a sertraline overdose. Consider contacting a Poison Center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.
Seizures, which may be delayed, and altered mental status including coma.
Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol.
Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk).
Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a sertraline overdose. Consider contacting a Poison Center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.
Storage
Store at 20°C to 25°C (68°F to 77°F). Short trips to 15°C to 30°C (59°F to 86°F) are permitted. Keep in tight containers. This is the Lupin label; other labelers may differ.
Section
16 HOW SUPPLIED/STORAGE AND HANDLING
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Note
Labeler-specific (Lupin). Medication Guide also says: Store sertraline hydrochloride tablets at room temperature, 68°F to 77°F (20°C to 25°C). Keep sertraline hydrochloride tablets bottle closed tightly.
Source text (exact source wording)
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature]. Preserve in tight containers.
Boxed warning
Antidepressants like sertraline raised the risk of suicidal thoughts and behavior 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 behavior.
Section
BOXED WARNING (Full Prescribing Information)
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior 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)].
Antidepressants increased the risk of suicidal thoughts and behavior 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)].
Contraindications
Do not take sertraline if you take an MAOI, including linezolid or intravenous methylene blue, or stopped one within 14 days, because of the risk of serotonin syndrome.
Section
4 CONTRAINDICATIONS
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Sertraline hydrochloride tablets are contraindicated in patients:
Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [See Warnings and Precautions (5.2), Drug Interactions (7.1)] .
Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [See Warnings and Precautions (5.2), Drug Interactions (7.1)] .
Do not take sertraline with pimozide.
Section
4 CONTRAINDICATIONS
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Taking pimozide [See Drug Interactions (7.1)].
Do not take sertraline if you are known to be allergic to it (for example anaphylaxis or angioedema).
Section
4 CONTRAINDICATIONS
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
With known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [See Adverse Reactions (6.1, 6.2)] .
Warnings and precautions
Patients should be watched for worsening and suicidal thoughts, especially in the first few months and at dose changes. Family members or caregivers should watch for behavior changes and tell the provider.
Section
5.1
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Heading
Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients
Source text (exact source wording)
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 sertraline hydrochloride tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
Sertraline can cause serotonin syndrome, a potentially life-threatening condition, especially with other serotonergic drugs or MAOIs. Signs include agitation, hallucinations, fast heartbeat, tremor, stiff muscles, seizures, nausea, vomiting and diarrhea.
Section
5.2
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Heading
Serotonin Syndrome
Source text (exact source wording)
Serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), including sertraline hydrochloride, 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, meperidine, methadone, tryptophan, buspirone, amphetamines, 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).
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).
Sertraline raises the risk of bleeding, and aspirin, NSAIDs, other antiplatelet drugs, warfarin and other anticoagulants may add to it. If you take warfarin the INR should be monitored carefully.
Section
5.3
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Heading
Increased Risk of Bleeding
Source text (exact source wording)
Drugs that interfere with serotonin reuptake inhibition, including sertraline hydrochloride, 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.
Inform patients of the increased risk of bleeding associated with the concomitant use of sertraline hydrochloride tablets and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio.
Inform patients of the increased risk of bleeding associated with the concomitant use of sertraline hydrochloride tablets and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio.
In people with bipolar disorder, sertraline may trigger a manic episode. Symptoms of mania or hypomania were reported in 0.4% of treated patients in trials. Providers should screen for a personal or family history first.
Section
5.4
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Heading
Activation of Mania or Hypomania
Source text (exact source wording)
In patients with bipolar disorder, treating a depressive episode with sertraline hydrochloride tablets or another antidepressant may precipitate a mixed/manic episode. In controlled clinical trials, patients with bipolar disorder were generally excluded; however, symptoms of mania or hypomania were reported in 0.4% of patients treated with sertraline hydrochloride tablets. Prior to initiating treatment with sertraline hydrochloride tablets, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.
Stopping suddenly can cause nausea, sweating, irritability, dizziness, electric shock sensations, anxiety, confusion, headache, insomnia, ringing in the ears and seizures. Lowering the dose gradually is recommended whenever possible.
Section
5.5
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Heading
Discontinuation Syndrome
Source text (exact source wording)
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)].
Sertraline has not been systematically studied in people with seizure disorders and should be used with caution.
Section
5.6
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Heading
Seizures
Source text (exact source wording)
Sertraline hydrochloride has not been systematically evaluated in patients with seizure disorders. Patients with a history of seizures were excluded from clinical studies. Sertraline hydrochloride tablets should be prescribed with caution in patients with a seizure disorder.
Sertraline may trigger an angle-closure eye attack in people with anatomically narrow angles. It should be avoided if the narrow angles are untreated.
Section
5.7
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Heading
Angle-Closure Glaucoma
Source text (exact source wording)
The pupillary dilation that occurs following use of many antidepressant drugs including sertraline 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 sertraline hydrochloride tablets, in patients with untreated anatomically narrow angles.
Low blood sodium can occur, with serum sodium lower than 110 mmol/L reported. Signs are headache, trouble concentrating, memory problems, confusion, weakness and unsteadiness. Older adults, people on diuretics and those low on body fluid are at greater risk.
Section
5.8
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Heading
Hyponatremia
Source text (exact source wording)
Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including sertraline hydrochloride. 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 may lead to falls. 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)].
Cases of QTc prolongation and Torsade de Pointes have been reported after approval. Use caution in patients with risk factors for QTc prolongation.
Section
5.10
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Heading
QTc Prolongation
Source text (exact source wording)
During post-marketing use of sertraline, cases of QTc prolongation and Torsade de Pointes (TdP) have been reported. Most reports were confounded by other risk factors. Therefore, sertraline hydrochloride tablets should be used with caution in patients with risk factors for QTc prolongation [See Drug Interactions (7.1), Clinical Pharmacology (12.2)].
SSRIs like sertraline may cause sexual problems. Men may have delayed or failed ejaculation, lower sex drive and erectile problems. Women may have lower sex drive and delayed or absent orgasm.
Section
5.11
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Heading
Sexual Dysfunction
Source text (exact source wording)
Use of SSRIs, including sertraline hydrochloride tablets, may cause symptoms of sexual dysfunction [see Adverse Reactions (6.1)]. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.
Sertraline can cause false-positive urine screening tests for benzodiazepines, which may last for several days after stopping.
Section
5.9
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Heading
False-Positive Effects on Screening Tests for Benzodiazepines
Source text (exact source wording)
False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking sertraline hydrochloride tablets. This finding is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of sertraline hydrochloride tablets.
Pregnancy and breastfeeding
Use in the month before delivery has been linked to a less than 2-fold increase in the risk of postpartum hemorrhage. Studies of first-trimester use suggest no difference in major birth defect risk overall, though some studies reported increases for specific defects and are inconclusive. Late-pregnancy use may lead to neonatal complications and persistent pulmonary hypertension of the newborn. Low levels of sertraline appear in breast milk. Talk to your provider about benefits and risks.
Section
8.1 Pregnancy and 8.2 Lactation
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Registry
Section
8.1 Pregnancy Exposure Registry
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388
Source text (exact source wording)
8.1 Pregnancy, Risk Summary: Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.3) and Clinical Considerations].
Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. Some studies have reported increases for specific major birth defects; however, these study results are inconclusive [See Data].
Fetal/Neonatal Adverse Reactions: Exposure to SSRIs and SNRIs, including sertraline hydrochloride in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN).
8.2 Lactation, Risk Summary: Available data from published literature demonstrate low levels of sertraline and its metabolites in human milk [See Data]. There are no data on the effects of sertraline on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for sertraline hydrochloride tablets and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. Some studies have reported increases for specific major birth defects; however, these study results are inconclusive [See Data].
Fetal/Neonatal Adverse Reactions: Exposure to SSRIs and SNRIs, including sertraline hydrochloride in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN).
8.2 Lactation, Risk Summary: Available data from published literature demonstrate low levels of sertraline and its metabolites in human milk [See Data]. There are no data on the effects of sertraline on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for sertraline hydrochloride tablets and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
Side effects
Common
The label's most common side effects (5% or more and twice the placebo rate) are nausea, diarrhea or loose stools, tremor, indigestion (dyspepsia), decreased appetite, increased sweating (hyperhidrosis), ejaculation failure and decreased libido. For specific conditions the label adds sleepiness, insomnia, agitation, constipation, fatigue, dry mouth, dizziness, abdominal pain and malaise.
Section
6.1 Clinical Trials Experience
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Threshold
≥5% and twice placebo
Source text (exact source wording)
The most common adverse reactions (≥5% and twice placebo) in all pooled placebo-controlled clinical trials of all sertraline hydrochloride-treated patients with MDD, OCD, PD, PTSD, SAD and PMDD were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (see Table 3). The following are the most common adverse reactions in trials of sertraline hydrochloride (≥5% and twice placebo) by indication that were not mentioned previously.
MDD: somnolence;
OCD: insomnia, agitation;
PD: constipation, agitation;
PTSD: fatigue;
PMDD: somnolence, dry mouth, dizziness, fatigue, and abdominal pain;
SAD: insomnia, dizziness, fatigue, dry mouth, malaise.
MDD: somnolence;
OCD: insomnia, agitation;
PD: constipation, agitation;
PTSD: fatigue;
PMDD: somnolence, dry mouth, dizziness, fatigue, and abdominal pain;
SAD: insomnia, dizziness, fatigue, dry mouth, malaise.
Less common
In the placebo-controlled table, rates for sertraline versus placebo included palpitations 4% vs 2%, visual impairment 4% vs 2%, constipation 6% vs 4%, vomiting 4% vs 1%, fatigue 12% vs 8%, dry mouth 14% vs 9%, dizziness 12% vs 8%, somnolence 11% vs 6% and insomnia 20% vs 13%. In men, erectile dysfunction was 4% vs 1%.
Section
6.1 Table 3
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Note
Table 3 flattened to text; rows at or above the ≥5%-and-twice-placebo threshold are in 'common'. Rows below that threshold (placebo-controlled table): palpitations 4% vs 2%, visual impairment 4% vs 2%, constipation 6% vs 4%, vomiting 4% vs 1%, fatigue 12% vs 8%, dry mouth 14% vs 9%, dizziness 12% vs 8%, somnolence 11% vs 6%, insomnia 20% vs 13%, agitation 8% vs 5%, erectile dysfunction (men) 4% vs 1%, ejaculation disorder (men) 3% vs 0%, male sexual dysfunction (men) 2% vs 0%.
Source text (exact source wording)
Table 3 (Sertraline Hydrochloride N=3066 vs Placebo N=2293; adverse reactions greater than 2% in sertraline-treated patients and at least 2% greater than placebo): Palpitations 4% vs 2%; Visual impairment 4% vs 2%; Nausea 26% vs 12%; Diarrhea/Loose Stools 20% vs 10%; Dry mouth 14% vs 9%; Dyspepsia 8% vs 4%; Constipation 6% vs 4%; Vomiting 4% vs 1%; Fatigue 12% vs 8%; Decreased appetite 7% vs 2%; Dizziness 12% vs 8%; Somnolence 11% vs 6%; Tremor 9% vs 2%; Insomnia 20% vs 13%; Agitation 8% vs 5%; Libido Decreased 6% vs 2%; Ejaculation failure (men only, n=1316 vs n=973) 8% vs 1%; Erectile dysfunction (men) 4% vs 1%; Ejaculation disorder (men) 3% vs 0%; Male sexual dysfunction (men) 2% vs 0%; Hyperhidrosis 7% vs 3%
Serious
Label
Reports after approval include severe liver problems, blood cell problems, angioedema, serotonin syndrome, acute kidney failure, severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and blood vessel problems in the brain.
Section
5.x and 6.2 Postmarketing Experience
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Postmarketing: Severe liver events (including hepatitis, jaundice, liver failure with some fatal outcomes), pancreatitis; Agranulocytosis, aplastic anemia and pancytopenia, leukopenia, thrombocytopenia, lupus-like syndrome, serum sickness; Angioedema; Serotonin syndrome, extrapyramidal symptoms (including akathisia and dystonia), oculogyric crisis; Acute renal failure; Pulmonary hypertension, eosinophilic pneumonia; Photosensitivity skin reaction and other severe cutaneous reactions, which potentially can be fatal, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN); Cerebrovascular spasm (including reversible cerebral vasoconstriction syndrome and Call- Fleming syndrome), vasculitis
Medlineplus
Call your doctor right away for seizures, abnormal bleeding or bruising, signs of serotonin syndrome, headache with weakness or confusion or memory problems, or rash, hives, swelling or trouble breathing.
Section
What side effects can this medication cause?
Source
MedlinePlus
Source url
https://medlineplus.gov/druginfo/meds/a697048.html
Source text (exact source wording)
Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately:
seizures
abnormal bleeding or bruising
agitation, hallucinations, fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, agitation, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
headache, weakness, unsteadiness, confusion, or memory problems
rash, hives, swelling, difficulty breathing
seizures
abnormal bleeding or bruising
agitation, hallucinations, fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, agitation, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
headache, weakness, unsteadiness, confusion, or memory problems
rash, hives, swelling, difficulty breathing
Led to discontinuation
In placebo-controlled studies 368 (12%) of 3066 sertraline patients stopped because of side effects versus 93 (4%) of 2293 on placebo. The common reasons were nausea (3%), diarrhea (2%), agitation (2%) and insomnia (2%).
Section
6.1 Adverse Reactions Leading to Discontinuation
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
In all placebo-controlled studies in patients with MDD, OCD, PD, PTSD, SAD and PMDD, 368 (12%) of the 3066 patients who received sertraline hydrochloride discontinued treatment due to an adverse reaction, compared with 93 (4%) of the 2293 placebo-treated patients. In placebo-controlled studies, the following were the common adverse reactions leading to discontinuation in sertraline hydrochloride-treated patients:
MDD, OCD, PD, PTSD, SAD and PMDD: nausea (3%), diarrhea (2%), agitation (2%), and insomnia (2%).
MDD, OCD, PD, PTSD, SAD and PMDD: nausea (3%), diarrhea (2%), agitation (2%), and insomnia (2%).
Interactions
Drugs
Taking an MAOI with sertraline raises the risk of serotonin syndrome and is contraindicated. Examples include selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid and methylene blue.
Name
Monoamine Oxidase Inhibitors (MAOIs)
Section
7.1 Clinically Significant Drug Interactions (Table 5)
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Clinical Impact: The concomitant use of SSRIs including sertraline hydrochloride and MAOIs increases the risk of serotonin syndrome. Intervention: Sertraline hydrochloride is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue. Examples: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue
Pimozide with sertraline may raise the risk of QTc prolongation and ventricular arrhythmias and is contraindicated.
Name
Pimozide
Section
7.1 Clinically Significant Drug Interactions (Table 5)
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Clinical Impact: Increased plasma concentrations of pimozide, a drug with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. Intervention: Concomitant use of pimozide and sertraline hydrochloride is contraindicated
Other serotonergic drugs (other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John's Wort) raise the risk of serotonin syndrome. Watch for signs, especially at the start and when doses go up.
Name
Other Serotonergic Drugs
Section
7.1 Clinically Significant Drug Interactions (Table 5)
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Clinical Impact: The concomitant use of serotonergic drugs with sertraline hydrochloride increases the risk of serotonin syndrome. Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. Examples: other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John's Wort
Aspirin, clopidogrel, heparin, warfarin and similar drugs may raise the bleeding risk with sertraline. If you take warfarin the INR should be monitored carefully.
Name
Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants)
Section
7.1 Clinically Significant Drug Interactions (Table 5)
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Clinical Impact: The concurrent use of an antiplatelet agent or anticoagulant with sertraline hydrochloride may potentiate the risk of bleeding. Intervention: ... For patients taking warfarin, carefully monitor the international normalized ratio. Examples: aspirin, clopidogrel, heparin, warfarin
Sertraline binds strongly to plasma protein, so combining it with another strongly bound drug such as warfarin may raise the free levels of either. Monitor for side effects and lower doses as warranted.
Name
Drugs Highly Bound to Plasma Protein (e.g., warfarin)
Section
7.1 Clinically Significant Drug Interactions (Table 5)
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Clinical Impact: Sertraline hydrochloride is highly bound to plasma protein. The concomitant use of sertraline hydrochloride with another drug that is highly bound to plasma protein may increase free concentrations of sertraline hydrochloride or other tightly-bound drugs in plasma. Intervention: Monitor for adverse reactions and reduce dosage of sertraline hydrochloride or other protein-bound drugs as warranted. Examples: warfarin
Sertraline inhibits CYP2D6, so it may increase exposure to drugs such as propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thoridazine, tolterodine and venlafaxine. Their dose may need to be lowered.
Name
Drugs Metabolized by CYP2D6
Section
7.1 Clinically Significant Drug Interactions (Table 5)
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Clinical Impact: Sertraline hydrochloride is a CYP2D6 inhibitor. The concomitant use of sertraline hydrochloride with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. Intervention: Decrease the dosage of a CYP2D6 substrate if needed with concomitant sertraline hydrochloride use. Examples: propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thoridazine, tolterodine, venlafaxine
Sertraline may raise phenytoin or fosphenytoin levels. Levels should be monitored and the phenytoin dose reduced if needed.
Name
Phenytoin
Section
7.1 Clinically Significant Drug Interactions (Table 5)
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Clinical Impact: Phenytoin is a narrow therapeutic index drug. Sertraline hydrochloride may increase phenytoin concentrations. Intervention: Monitor phenytoin levels when initiating or titrating sertraline hydrochloride. Reduce phenytoin dosage if needed. Examples: phenytoin, fosphenytoin
Using sertraline with other drugs that prolong the QTc interval raises the risk of dangerous heart rhythms. The label says to avoid such combinations; examples include certain antipsychotics, certain antibiotics, quinidine, procainamide, amiodarone and sotalol.
Name
Drugs that Prolong the QTc Interval
Section
7.1 Clinically Significant Drug Interactions (Table 5)
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Clinical Impact: The risk of QTc prolongation and/or ventricular arrhythmias (e.g., TdP) is increased with concomitant use of other drugs which prolong the QTc interval. Intervention: Pimozide is contraindicated for use with sertraline. Avoid the concomitant use of drugs known to prolong the QTc interval. Examples: Specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin); Class 1A antiarrhythmic medications (e.g., quinidine, procainamide); Class III antiarrhythmics (e.g., amiodarone, sotalol); and others
No sertraline dose change is needed with cimetidine, diazepam, lithium, atenolol, tolbutamide, digoxin or drugs metabolized by CYP3A4, based on the label's studies. Note the label separately lists lithium as a serotonergic drug to monitor for serotonin syndrome.
Name
Drugs having no clinically important interaction (7.2)
Section
7.1 Clinically Significant Drug Interactions (Table 5)
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Based on pharmacokinetic studies, no dosage adjustment of sertraline hydrochloride is necessary when used in combination with cimetidine. Additionally, no dosage adjustment is required for diazepam, lithium, atenolol, tolbutamide, digoxin, and drugs metabolized by CYP3A4, when sertraline hydrochloride is administered concomitantly [See Clinical Pharmacology (12.3)].
Food and alcohol
The Medication Guide says not to drink alcohol while taking sertraline. MedlinePlus says to ask your doctor about the safe use of alcoholic beverages because alcohol can make side effects worse. These two statements differ in strength (see conflicts).
Name
Alcohol
Section
Medication Guide (part of the same Lupin label), What should I avoid while taking sertraline hydrochloride tablets?
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Do not drink alcohol while you take sertraline hydrochloride tablets.
Ask your doctor about alcohol; it can make side effects worse.
Name
Alcohol (MedlinePlus)
Section
What special precautions should I follow?
Source
MedlinePlus
Source url
https://medlineplus.gov/druginfo/meds/a697048.html
Source text (exact source wording)
ask your doctor about the safe use of alcoholic beverages while you are taking sertraline. Alcohol can make the side effects of sertraline worse
Name
Food
Section
Medication Guide (part of the same Lupin label), How should I take
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Sertraline hydrochloride tablets may be taken with or without food.
Patient tips
Label medication guide
Do not stop sertraline suddenly; it can cause anxiety, irritability, mood changes, headache, sweating, nausea, dizziness, electric shock-like sensations, shaking and confusion. It can cause sleepiness, so do not drive or use heavy machinery until you know how it affects you. Do not drink alcohol while taking it.
Section
Medication Guide (part of the same Lupin label)
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Do not stop sertraline hydrochloride tablets without first talking to your healthcare provider. Stopping sertraline hydrochloride tablets too quickly may cause serious symptoms including:
anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
headache, sweating, nausea, dizziness
electric shock-like sensations, shaking, confusion
Sertraline hydrochloride tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how sertraline hydrochloride tablets affect you. Do not drink alcohol while you take sertraline hydrochloride tablets.
anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
headache, sweating, nausea, dizziness
electric shock-like sensations, shaking, confusion
Sertraline hydrochloride tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how sertraline hydrochloride tablets affect you. Do not drink alcohol while you take sertraline hydrochloride tablets.
Label medication guide call provider
Call your provider right away, or 911 in an emergency, for new or worse depression, thoughts about suicide or dying, aggressive or violent acts, agitation, restlessness, anger, irritability, dangerous impulses, new or worse anxiety or panic attacks, trouble sleeping or unusual changes in mood or behavior. The risk is higher in people 24 years of age and younger, especially in the first few months or at dose changes.
Section
Medication Guide (part of the same Lupin label)
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Source text (exact source wording)
Sertraline hydrochloride tablets and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: attempts to commit suicide; acting aggressive or violent; new or worse depression; feeling agitated, restless, angry or irritable; an increase in activity or talking more than what is normal for you; acting on dangerous impulses; thoughts about suicide or dying; new or worse anxiety or panic attacks; trouble sleeping; other unusual changes in behavior or mood
Medlineplus how to take
Take it once a day, in the morning or evening, around the same time each day. It may take a few weeks or longer to feel the full benefit. Keep taking it even if you feel well and do not stop without talking to your doctor.
Section
How should this medicine be used?
Source
MedlinePlus
Source url
https://medlineplus.gov/druginfo/meds/a697048.html
Source text (exact source wording)
Take once daily in the morning or evening. To treat premenstrual dysphoric disorder, take once a day, either every day of the month or on certain days of the month. Take sertraline at around the same time every day.
It may take a few weeks or longer before you feel the full benefit of sertraline. Continue to take sertraline even if you feel well. Do not stop taking sertraline without talking to your doctor.
It may take a few weeks or longer before you feel the full benefit of sertraline. Continue to take sertraline even if you feel well. Do not stop taking sertraline without talking to your doctor.
Reporting
FDA MedWatch: 1-800-FDA-1088. Poison control: 1-800-222-1222 (MedlinePlus).
Alternatives
Class
selective serotonin reuptake inhibitor (SSRI)
Class source
MedlinePlus sertraline page
Class source url
https://medlineplus.gov/druginfo/meds/a697048.html
Openfda note
openFDA count of pharm_class_epc for SERTRALINE HYDROCHLORIDE returned 'Nothing to count'; a count of 'Serotonin Reuptake Inhibitor [EPC]' returned only citalopram and fluoxetine HCl, so openFDA could not confirm sertraline's class.
Openfda url
https://api.fda.gov/drug/label.json?search=openfda.pharm_class_epc.exact:"Serotonin Reuptake Inhibitor [EPC]"&count=openfda.generic_name.exact&limit=15
Candidates
- citalopram
- fluoxetine
Candidates source
openFDA label endpoint class list; other SSRIs not sourced in this run
Candidates source url
https://api.fda.gov/drug/label.json?search=openfda.pharm_class_epc.exact:"Serotonin Reuptake Inhibitor [EPC]"&count=openfda.generic_name.exact&limit=15
Recommendation
none
Frequently asked questions
Question
What is sertraline used for?
Answer
Sertraline treats major depressive disorder, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, social anxiety disorder and premenstrual dysphoric disorder.
Source section
1 INDICATIONS AND USAGE
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Question
Can I take sertraline with food?
Answer
Yes. The Medication Guide says sertraline hydrochloride tablets may be taken with or without food.
Source section
Medication Guide, How should I take
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Question
What if I miss a dose?
Answer
Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses at the same time.
Source section
Medication Guide, How should I take
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Question
Can I drink alcohol on sertraline?
Answer
The Medication Guide says do not drink alcohol while you take sertraline. MedlinePlus says to ask your doctor about alcohol because it can make side effects worse.
Source section
Medication Guide, What should I avoid; MedlinePlus precautions
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Question
What are the most common side effects?
Answer
The label's most common reactions (5% or more and twice placebo) are nausea, diarrhea or loose stools, tremor, indigestion, decreased appetite, increased sweating, ejaculation failure and decreased libido.
Source section
6.1 Clinical Trials Experience
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Question
Is sertraline safe in pregnancy or breastfeeding?
Answer
The label says studies of first-trimester use suggest no difference in major birth defect risk overall, though some studies reported increases for specific defects and are inconclusive. Late-pregnancy use may lead to neonatal complications and persistent pulmonary hypertension of the newborn. Low levels of sertraline appear in breast milk. Talk with your provider about benefits and risks.
Source section
8.1 Pregnancy; 8.2 Lactation
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Question
What should I not combine with sertraline?
Answer
Do not take sertraline with an MAOI (including linezolid or intravenous methylene blue) or within 14 days of stopping one, or with pimozide. Other serotonergic drugs, aspirin, NSAIDs, warfarin and other blood thinners need careful monitoring.
Source section
4 CONTRAINDICATIONS; 7.1 Table 5
Source
DailyMed label, Lupin Pharmaceuticals, Inc. sertraline hydrochloride tablets, set ID 42120ff8-b353-4632-9ea9-54de9a698724
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=42120ff8-b353-4632-9ea9-54de9a698724&type=display
Question
Should I stop sertraline when I feel better?
Answer
No. MedlinePlus says to keep taking it even if you feel well. The Medication Guide says not to stop without first talking to your healthcare provider, because stopping too quickly may cause serious symptoms.
Source section
Medication Guide; MedlinePlus How should this medicine be used?
Source
MedlinePlus and label
Source url
https://medlineplus.gov/druginfo/meds/a697048.html
Sources
- DailyMed sertraline hydrochloride tablets, Lupin Pharmaceuticals, Inc.
Set id: 42120ff8-b353-4632-9ea9-54de9a698724 · Label effective or revised date: Revised: 10/2025 · Dailymed version date: DailyMed list published_date Feb 09, 2026 · Fetched at: 2026-11-03 · Sections used: Boxed Warning, 1-5, 6.1-6.2, 7, 8, 9.1, 10, 12.1, 16, Medication Guide - MedlinePlus Sertraline
Label effective or revised date: Last Revised - 10/15/2025 · Fetched at: 2026-11-03 · Sections used: all patient sections - openFDA label endpoint (class check)
Fetched at: 2026-11-03 · Sections used: class counts - DailyMed spls.json sertraline list
Fetched at: 2026-11-02 · Sections used: page 1 of 3
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