Tramadol

Generic name: tramadol hydrochloride · Brand names: Ultram, Ultram ER, Conzip, Qdolo

Quick facts

Drug class
Section
Highlights, Indications and Usage
Source
DailyMed label, Amneal Pharmaceuticals NY LLC
Source text (exact source wording)
Tramadol hydrochloride tablets are an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Rx or otc
Value
Rx
Section
Highlights title (prescription opioid; label carries C-IV and Medication Guide)
Source
DailyMed label
Source text (exact source wording)
TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV
Controlled schedule
Value
Schedule IV (C-IV)
Section
5.1 Addiction, Abuse and Misuse
Source
DailyMed label
Source text (exact source wording)
Tramadol hydrochloride tablets contain tramadol, a Schedule IV controlled substance.
Forms and strengths
Section
3 Dosage Forms and Strengths
Source text (exact source wording)
Tramadol Hydrochloride Tablets USP, 50 mg are supplied as white, round film-coated tablets, debossed “AN” over “627” on one side and scored on other side.
Generic available
Value
yes
Source text (exact source wording)
Marketing category on label: Abbreviated New Drug Application (ANDA)
Common use one line
Used in adults for pain severe enough to need an opioid pain medicine when other treatments do not work well enough.

What it is used for

Tramadol is used in adults for pain that is bad enough to need an opioid pain medicine, when other treatments are not enough. Because opioids can cause addiction, abuse, misuse, overdose and death, they are kept for people who cannot get enough relief from other options.
Section
1 Indications and Usage
Source
DailyMed label (Amneal)
Source text (exact source wording)
Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including tramadol hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

How it works

Tramadol is an opioid pain medicine that also affects the brain chemicals norepinephrine and serotonin. The label says exactly how it works is not completely understood. Pain relief begins about one hour after a dose and peaks in about two to three hours.
Section
12.1 Mechanism of Action (first and last paragraph; middle paragraph omitted)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Tramadol hydrochloride tablets contains tramadol, an opioid agonist and inhibitor of norepinephrine and serotonin re-uptake. Although the mode of action is not completely understood, the analgesic effect of tramadol is believed to be due to both binding to μ-opioid receptors and weak inhibition of re-uptake of norepinephrine and serotonin. Analgesia in humans begins approximately within one hour after administration and reaches a peak in approximately two to three hours.

Dosage: adults

For people who do not need fast relief, the label describes starting at 25 mg/day and raising the dose in steps every 3 days, up to 200 mg/day. After that, 50 mg to 100 mg can be taken as needed every 4 to 6 hours. The daily total must not go over 400 mg. Your prescriber sets your own dose.
Section
2.3 Initial Dosage; 2.1 Important Dosage and Administration Instructions
Source
DailyMed label (Amneal)
Source text (exact source wording)
For patients not requiring rapid onset of analgesic effect, the tolerability of tramadol hydrochloride tablets can be improved by initiating therapy with the following titration regimen: Start tramadol hydrochloride tablets at 25 mg/day and titrated in 25 mg increments as separate doses every 3 days to reach 100 mg/day (25 mg four times a day). Thereafter the total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg four times a day). After titration, tramadol hydrochloride tablets 50 mg to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day. For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, tramadol hydrochloride tablets 50 mg to 100 mg can be administered as needed for pain relief every four to six hours, not to exceed 400 mg per day. Do not administer tramadol hydrochloride tablets at a dose exceeding 400 mg per day.

Dosage: children

Safety and effectiveness in children have not been established. Tramadol must not be used in children younger than 12 years, or in anyone younger than 18 years after tonsil or adenoid surgery.
Section
8.4 Pediatric Use
Source
DailyMed label (Amneal)
Source text (exact source wording)
The safety and effectiveness of tramadol hydrochloride tablets in pediatric patients have not been established. Tramadol hydrochloride tablets are contraindicated for all children younger than 12 years of age [see Contraindications (4)]. Tramadol hydrochloride tablets are contraindicated for postoperative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Contraindications (4)].

Dosage adjustments

Kidney
If creatinine clearance is less than 30 mL/min, the time between doses is increased to 12 hours and the daily maximum is 200 mg. Only 7% of a dose is removed by hemodialysis, so dialysis patients can take their regular dose on the day of dialysis.
Section
2.3 Initial Dosage (Dosage Modification in Patients with Renal Impairment)
Source
DailyMed label (Amneal)
Source text (exact source wording)
In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of tramadol hydrochloride tablets be increased to 12 hours, with a maximum daily dose of 200 mg. Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis.
Liver
For adults with severe liver impairment, the recommended dose is 50 mg every 12 hours.
Section
2.3 Initial Dosage (Dosage Modification in Patients with Hepatic Impairment)
Source
DailyMed label (Amneal)
Source text (exact source wording)
The recommended dose for adult patients with severe hepatic impairment is 50 mg every 12 hours.
Elderly
People over 75 years old should not take more than 300 mg/day in total.
Section
2.3 Initial Dosage (Dosage Modification in Geriatric Patients)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Do not exceed a total dose of 300 mg/day in patients over 75 years old.

Missed dose

If your doctor told you to take tramadol on a regular schedule, take a missed dose as soon as you remember. If it is almost time for the next dose, skip the missed one. Never take a double dose.
Section
What should I do if I forget a dose?
Source
MedlinePlus (https://medlineplus.gov/druginfo/meds/a695011.html), last revised 09/15/2026. The DailyMed label body has no missed-dose section (not checked in the Medication Guide).
Source text (exact source wording)
If your doctor has told you to take tramadol regularly, 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

An overdose can cause slow or stopped breathing, extreme sleepiness that can lead to coma, cold clammy skin, small pupils, seizures and death. For an overdose, call poison control at 1-800-222-1222. If the person has collapsed, had a seizure, has trouble breathing or cannot be woken, call 911. A rescue medicine such as naloxone or nalmefene can reverse some effects.
Section
10 Overdosage (selected paragraphs)
Source
DailyMed label (Amneal)
Medlineplus source
MedlinePlus In case of emergency/overdose
Source text (exact source wording)
Acute overdosage with tramadol hydrochloride tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, seizures, and death. For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene. Hemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period.
Medlineplus 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. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Storage

Store at 20° to 25°C (68° to 77°F); brief trips between 15° to 30°C (59° to 86°F) are allowed. Keep it in a tight container, store it securely and dispose of unused tablets properly.
Section
16 How Supplied/Storage and Handling
Source
DailyMed label (Amneal); labeler-specific, other labelers may differ
Source text (exact source wording)
Dispense in a tight container. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store tramadol hydrochloride tablets securely and dispose of properly [see Patient Counseling Information (17)].

Boxed warning

Tramadol can be addictive and can be abused or misused, which can lead to overdose and death. It can cause serious, life-threatening or fatal slowed breathing, especially at the start or after a dose increase. Even one dose taken by accident, especially by a child, can be fatal. Taking it with benzodiazepines, other central nervous system depressants or alcohol can cause profound sedation, slowed breathing, coma and death. Using opioids for an extended time in pregnancy can cause life-threatening withdrawal in the newborn. Children younger than 12 and children younger than 18 after tonsil or adenoid surgery must not take it. Some medicines that affect liver enzymes (CYP3A4 and 2D6) change how tramadol works in complex ways.
Title
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TRAMADOL HYDROCHLORIDE TABLETS
Section
Boxed Warning (Full Prescribing Information)
Source
DailyMed label (Amneal), printer-friendly page, copied from get_page_text output. Note: the label's own cross-reference for Accidental Ingestion reads 5.5 in the full boxed warning (the highlights cite 5.2); copied as printed.
Source text verbatim (exact source wording)
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TRAMADOL HYDROCHLORIDE TABLETS

Addiction, Abuse and Misuse

Because the use of tramadol hydrochloride tablets exposes patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of tramadol hydrochloride tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of tramadol hydrochloride tablets are essential [see Warnings and Precautions (5.2)].

Accidental Ingestion

Accidental ingestion of even one dose of tramadol hydrochloride tablets, especially by children, can result in a fatal overdose of tramadol [see Warnings and Precautions (5.5)].

Risks From Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of tramadol hydrochloride tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3); Drug Interactions (7)].

Neonatal Opioid Withdrawal Syndrome (NOWS)

Advise pregnant women, using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.4)].

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions (5.5)].

Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children

Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism [see Warnings and Precautions (5.6)]. Tramadol hydrochloride tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Contraindications (4)]. Avoid the use of tramadol hydrochloride tablets in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol [see Warnings and Precautions (5.6)].

Interactions with Drugs Affecting Cytochrome P450 Isoenzymes

The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol hydrochloride tablets requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1 [see Warnings and Precautions (5.7); Drug Interactions (7)].

Contraindications

Do not use tramadol in children younger than 12, or in anyone younger than 18 after tonsil or adenoid surgery. Do not use it with significant slowed breathing, acute or severe asthma in an unmonitored setting, a known or suspected blocked stomach or intestine (including paralytic ileus), or an allergy to tramadol or opioids. Do not use it with MAOIs or within 14 days of stopping one.
Section
4 Contraindications
Source
DailyMed label (Amneal)
Source text (exact source wording)
Tramadol hydrochloride tablets are contraindicated for: all children younger than 12 years of age [see Warnings and Precautions (5.6)]. postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.6)]. Tramadol hydrochloride tablets are also contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2)]. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.12)]. Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.16)]. Hypersensitivity to tramadol, any other component of this product or opioids [see Warnings and Precautions (5.17)]. Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days [see Drug Interactions (7)].

Warnings and precautions

Tramadol is a Schedule IV controlled substance and carries risks of addiction, abuse and misuse. Addiction can happen even when it is prescribed correctly and taken at recommended doses. The risk of overdose or death is higher with higher doses.
Heading
5.1 Addiction, Abuse and Misuse
Section
5.1 (first two paragraphs)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Tramadol hydrochloride tablets contain tramadol, a Schedule IV controlled substance. As an opioid, tramadol hydrochloride tablets exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed tramadol hydrochloride tablets. Addiction can occur at recommended dosages and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy.
Opioids can cause serious, life-threatening or fatal slowed breathing, even when used as recommended. The risk is greatest when starting or after a dose increase. Even one dose taken by accident, especially by a child, can cause breathing problems and death.
Heading
5.2 Life-Threatening Respiratory Depression
Section
5.2 (selected paragraphs)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of tramadol hydrochloride tablets, the risk is greatest during the initiation of therapy or following a dosage increase. Accidental ingestion of even one dose of tramadol hydrochloride tablets, especially by children, can result in respiratory depression and death due to an overdose of tramadol.
Taking tramadol with benzodiazepines or other central nervous system depressants, including alcohol, can cause profound sedation, slowed breathing, coma and death.
Heading
5.3 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
Section
5.3 (first paragraph)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Profound sedation, respiratory depression, coma, and death may result from the concomitant use of tramadol hydrochloride tablets with benzodiazepines and/or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
Using tramadol for a long time during pregnancy can cause withdrawal in the newborn, which can be life-threatening if not recognized and treated.
Heading
5.4 Neonatal Opioid Withdrawal Syndrome
Section
5.4 (first two sentences)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Use of tramadol hydrochloride tablets for an extended period of time during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.
Children have had life-threatening slowed breathing and death on tramadol. Some people convert tramadol to its active form very fast (ultra-rapid metabolizers) and can have life-threatening breathing problems even at labeled doses, so they should not use it. Breastfeeding is not recommended during treatment.
Heading
5.6 Ultra-Rapid Metabolism and Other Risk Factors for Life-threatening Respiratory Depression in Children
Section
5.6 (selected sentences from Nursing Mothers and CYP2D6 paragraphs, joined in label order)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Life-threatening respiratory depression and death have occurred in children who received tramadol. Tramadol is subject to the same polymorphic metabolism as codeine, with ultra-rapid metabolizers of CYP2D6 substrates being potentially exposed to life-threatening levels of the active metabolite O-desmethyltramadol (M1). For this reason, breastfeeding is not recommended during treatment with tramadol hydrochloride tablets [see Use in Specific Populations (8.2)]. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing) [see Overdosage (10)]. Therefore, individuals who are ultra-rapid metabolizers should not use tramadol hydrochloride tablets.
Tramadol can cause serotonin syndrome, a potentially life-threatening condition, especially with serotonin-related drugs. Symptoms can include agitation, hallucinations, coma, fast heartbeat, unstable blood pressure, high body temperature, overactive reflexes, loss of coordination, rigidity, nausea, vomiting and diarrhea. It should be stopped if suspected.
Heading
5.9 Serotonin Syndrome Risk
Section
5.9 (selected sentences in label order)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Cases of serotonin syndrome, a potentially life-threatening condition, have been reported with the use of tramadol, particularly during concomitant use with serotonergic drugs. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Discontinue tramadol hydrochloride tablets if serotonin syndrome is suspected.
Seizures have happened at recommended doses, and the risk is higher with doses above the recommended range.
Heading
5.10 Increased Risk of Seizures
Section
5.10 (first paragraph)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Seizures have been reported in patients receiving tramadol hydrochloride tablets within the recommended dosage range. Spontaneous postmarketing reports indicate that seizure risk is increased with doses of tramadol hydrochloride tablets above the recommended range.
Tramadol should not be prescribed for people who are suicidal or addiction-prone.
Heading
5.11 Suicide Risk
Section
5.11 (first paragraph)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Do not prescribe tramadol hydrochloride tablets for patients who are suicidal or addiction-prone. Consideration should be given to the use of non-narcotic analgesics in patients who are suicidal or depressed [see Drug Abuse and Dependence (9)].
Opioids can cause adrenal insufficiency, more often after more than one month of use. Signs can include nausea, vomiting, loss of appetite, fatigue, weakness, dizziness and low blood pressure.
Heading
5.13 Adrenal Insufficiency
Section
5.13 (first two sentences)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.
Tramadol may cause severe low blood pressure, including a drop when standing up and fainting.
Heading
5.14 Severe Hypotension
Section
5.14 (first sentence)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Tramadol hydrochloride tablets may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients.
Serious and rarely fatal allergic reactions (anaphylaxis) have been reported, often after the first dose. Other allergic reactions include itching, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome.
Heading
5.17 Anaphylaxis and Other Hypersensitivity Reactions
Section
5.17 (first three sentences)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Serious and rarely fatal anaphylactic reactions have been reported in patients receiving therapy with tramadol hydrochloride tablets. When these events do occur it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome.
Do not stop tramadol suddenly or cut the dose quickly if you are physically dependent on opioids. The dose should be lowered gradually.
Heading
5.18 Withdrawal
Section
5.18 (first two sentences)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Do not rapidly reduce or abruptly discontinue tramadol hydrochloride tablets in a patient physically dependent on opioids. When discontinuing tramadol hydrochloride tablets in a physically dependent patient, gradually taper the dosage.
Tramadol may impair the mental or physical abilities needed to drive a car or operate machinery.
Heading
5.19 Risks of Driving and Operating Machinery
Section
5.19 (first sentence)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Tramadol hydrochloride tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
Low blood sodium has been reported with tramadol, and many cases were severe. Most cases were in females over the age of 65 and within the first week of therapy.
Heading
5.20 Hyponatremia
Section
5.20 (first two sentences)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Hyponatremia (serum sodium < 135 mmol/L) has been reported with the use of tramadol, and many cases are severe (sodium level < 120 mmol/L). Most cases of hyponatremia occurred in females over the age of 65 and within the first week of therapy.
Low blood sugar has been reported with tramadol, some cases requiring hospitalization, mostly in people with risk factors such as diabetes.
Heading
5.21 Hypoglycemia
Section
5.21 (first two sentences)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Cases of tramadol-associated hypoglycemia have been reported, some resulting in hospitalization. In most cases, patients had predisposing risk factors (e.g. diabetes).

Pregnancy and breastfeeding

Using tramadol for a long time during pregnancy may cause withdrawal in the newborn. There is not enough data to say if it raises the risk of major birth defects or miscarriage. It is not recommended during or just before labor. Tramadol and its active product pass into breast milk and can cause excess sedation and slowed breathing in a nursing baby, so breastfeeding is not recommended.
Section
8.1 Pregnancy (Risk Summary, Labor or Delivery); 8.2 Lactation (Risk Summary), selected sentences in label order
Source
DailyMed label (Amneal)
Medlineplus source
MedlinePlus (IMPORTANT WARNING; What special precautions)
Source text (exact source wording)
Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)]. Available data with tramadol hydrochloride tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Tramadol hydrochloride tablet is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Tramadol and its metabolite, O-desmethyltramadol (M1), are present in human milk. Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with tramadol hydrochloride tablets [see Warnings and Precautions (5.6)].
Medlineplus source text (exact source wording)
Tell your doctor if you are pregnant or plan to become pregnant. If you take tramadol regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. tell your doctor if you are breastfeeding. You should not breastfeed while taking tramadol.

Side effects

Common
The label calls these the most common side effects in clinical trials (15% or more of patients): dizziness or vertigo, nausea, constipation, headache, sleepiness, vomiting and itching.
Threshold
The label's highlights state: most common incidence of treatment-emergent adverse events (≥15.0%)
Section
Highlights, Adverse Reactions
Source
DailyMed label (Amneal)
Table note
Section 6.1 Table 1 lists 7-day incidence for these: Dizziness/Vertigo 26%, Nausea 24%, Constipation 24%, Headache 18%, Somnolence 16%, Vomiting 9%, Pruritus 8%. Vomiting (9%) and pruritus (8%) are below 15% at 7 days in Table 1 although the highlights list them; this internal difference in the label is flagged, not resolved.
Source text (exact source wording)
The most common incidence of treatment-emergent adverse events (≥15.0%) in patients from clinical trials were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting and pruritus. (6)
Less common
Other side effects seen in the trials include a group the label calls CNS stimulation (7% by 7 days), weakness (6%), sweating (6%), indigestion (5%), dry mouth (5%) and diarrhea (5%). Reactions in 1% to less than 5% of patients include malaise, anxiety, confusion, euphoria, abdominal pain, loss of appetite, gas, rash, visual disturbance and urinary frequency or retention.
Section
6.1 Clinical Trials Experience (Table 1 rows below the highlights list, plus the 1% to less than 5% list)
Source
DailyMed label (Amneal)
Source text (exact source wording)
Table 1 (cumulative incidence up to 7 days / 30 days / 90 days, N=427): “CNS Stimulation” 7% / 11% / 14%; Asthenia 6% / 11% / 12%; Sweating 6% / 7% / 9%; Dyspepsia 5% / 9% / 13%; Dry Mouth 5% / 9% / 10%; Diarrhea 5% / 6% / 10%. Incidence 1% to Less than 5% Possibly Causally Related: Body as a Whole: Malaise. Cardiovascular: Vasodilation. Central Nervous System: Anxiety, Confusion, Coordination disturbance, Euphoria, Miosis, Nervousness, Sleep disorder. Gastrointestinal: Abdominal pain, Anorexia, Flatulence. Musculoskeletal: Hypertonia. Skin: Rash. Special Senses: Visual disturbance. Urogenital: Menopausal symptoms, Urinary frequency, Urinary retention.
Serious
Serious problems named by the label include addiction, slowed breathing, withdrawal in newborns, serotonin syndrome, seizures, low blood pressure, adrenal insufficiency, allergic reactions, QT prolongation, very low sodium and low blood sugar. MedlinePlus says to call your doctor right away or get emergency help for hives, rash or blisters, trouble swallowing or breathing, chest pain, swelling of the face or limbs, agitation or hallucinations with fever, a fast or changed heartbeat, loss of consciousness or seizures.
Label section
6 Adverse Reactions (intro list, joined without the bracketed cross-references); 6.2 Post-marketing Experience (selected sentences)
Label source
DailyMed label (Amneal)
Medlineplus source
MedlinePlus What side effects can this medication cause?
Label source text (exact source wording)
The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression; Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children; Neonatal Opioid Withdrawal Syndrome; Interactions with Benzodiazepines or Other CNS Depressants; Opioid-Induced Hyperalgesia and Allodynia; Serotonin Syndrome; Seizures; Suicide; Adrenal Insufficiency; Severe Hypotension; Gastrointestinal Adverse Reactions; Hypersensitivity Reactions; Withdrawal. Postmarketing: Cases of QT prolongation and/or torsade de pointes have been reported with tramadol use. Cases of severe hyponatremia and/or SIADH have been reported in patients taking tramadol, most often in females over the age of 65, and within the first week of therapy. Cases of hypoglycemia have been reported in patients taking tramadol.
Medlineplus source text (exact source wording)
Some side effects can be serious. If you experience any of these symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment: hives, rash, blisters; hoarseness, difficulty swallowing or breathing; chest pain; swelling of the eyes, face, throat, tongue, lips, hands, feet, ankles, or lower legs; agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, or diarrhea; nausea, vomiting, loss of appetite, fatigue, weakness, or dizziness; changes in heartbeat; headache, confusion, loss of energy, drowsiness, restlessness, muscle weakness, spasms or cramps; hunger, shaking of a part of your body that you cannot control, irritability, or difficulty concentrating; loss of consciousness; seizures
Led to discontinuation
In older patients, 30% of those over 75 years had stomach or bowel side effects that limited treatment, compared with 17% of those under 65 years. Constipation led 10% of those over 75 to stop treatment.
Section
8.5 Geriatric Use. Section 6.1 also states: the rates of withdrawals due to adverse events appeared to be higher in the tramadol hydrochloride tablets groups. (no overall discontinuation percentage was captured)
Source
DailyMed label (Amneal)
Source text (exact source wording)
In studies including geriatric patients, treatment-limiting adverse events were higher in subjects over 75 years of age compared to those under 65 years of age. Specifically, 30% of those over 75 years of age had gastrointestinal treatment-limiting adverse events compared to 17% of those under 65 years of age. Constipation resulted in discontinuation of treatment in 10% of those over 75.

Interactions

Drugs
Medicines such as quinidine, fluoxetine, paroxetine and bupropion can raise tramadol levels and lower its active form. Patients need frequent checks for withdrawal, seizures and serotonin syndrome.
Name
Inhibitors of CYP2D6
Section
7 Table 2
Source text (exact source wording)
If concomitant use of a CYP2D6 inhibitor is necessary, evaluate patients at frequent intervals for adverse reactions including opioid withdrawal, seizures and serotonin syndrome. Examples: Quinidine, fluoxetine, paroxetine and bupropion
Macrolide antibiotics, azole antifungals and protease inhibitors can raise tramadol levels. The label says a lower tramadol dose may be considered.
Name
Inhibitors of CYP3A4
Section
7 Table 2
Source text (exact source wording)
If concomitant use is necessary, consider dosage reduction of tramadol hydrochloride tablet until stable drug effects are achieved. Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir)
Rifampin, carbamazepine and phenytoin can lower tramadol levels. The label says carbamazepine and tramadol together are not recommended.
Name
CYP3A4 Inducers
Section
7 Table 2
Source text (exact source wording)
Patients taking carbamazepine, a CYP3A4 inducer, may have a significantly reduced analgesic effect of tramadol. Because carbamazepine increases tramadol metabolism and because of the seizure risk associated with tramadol, concomitant administration of tramadol hydrochloride tablet and carbamazepine is not recommended. Examples: Rifampin, carbamazepine, phenytoin
Using these with tramadol raises the risk of slowed breathing, profound sedation, coma and death.
Name
Benzodiazepines and Other Central Nervous System (CNS) Depressants
Section
7 Table 2
Source text (exact source wording)
Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, and alcohol.
Combining tramadol with drugs that affect serotonin has led to serotonin syndrome. The label lists SSRIs, SNRIs, TCAs, triptans, mirtazapine, trazodone, cyclobenzaprine, metaxalone, MAO inhibitors, linezolid and intravenous methylene blue.
Name
Serotonergic Drugs
Section
7 Table 2
Source text (exact source wording)
The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Do not use tramadol with MAOIs or within 14 days of stopping one.
Name
Monoamine Oxidase Inhibitors (MAOIs)
Section
7 Table 2
Source text (exact source wording)
Do not use tramadol hydrochloride tablet in patients taking MAOIs or within 14 days of stopping such treatment. Examples: phenelzine, tranylcypromine, linezolid
Butorphanol, nalbuphine, pentazocine and buprenorphine may reduce tramadol's effect or cause withdrawal. The label says to avoid using them together.
Name
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
Section
7 Table 2
Source text (exact source wording)
May reduce the analgesic effect of tramadol hydrochloride tablet and/or precipitate withdrawal symptoms. Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine
Tramadol may strengthen muscle relaxants and increase slowed breathing (examples: cyclobenzaprine, metaxalone).
Name
Muscle Relaxants
Section
7 Table 2
Source text (exact source wording)
Tramadol may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Examples: cyclobenzaprine, metaxalone
Opioids can make diuretics work less well.
Name
Diuretics
Section
7 Table 2
Source text (exact source wording)
Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
Anticholinergic drugs may raise the risk of urinary retention and severe constipation.
Name
Anticholinergic Drugs
Section
7 Table 2
Source text (exact source wording)
The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
There have been rare reports of digoxin toxicity with tramadol.
Name
Digoxin
Section
7 Table 2
Source text (exact source wording)
Postmarketing surveillance of tramadol has revealed rare reports of digoxin toxicity.
There have been rare reports of changes in warfarin effect, including raised prothrombin times.
Name
Warfarin
Section
7 Table 2
Source text (exact source wording)
Postmarketing surveillance of tramadol has revealed rare reports of alteration of warfarin effect, including elevation of prothrombin times.
Food and alcohol
Alcohol with tramadol can cause profound sedation, slowed breathing, coma and death.
Name
Alcohol
Section
Boxed Warning (Risks From Concomitant Use with Benzodiazepines or Other CNS Depressants)
Source text (exact source wording)
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
Name
Food
Section
What special dietary instructions should I follow? (MedlinePlus)
Source text (exact source wording)
Unless your doctor tells you otherwise, continue your normal diet.
Other
St. John's wort and tryptophan may interact with tramadol; do not start them without talking to your healthcare provider.
Name
St. John's wort and tryptophan
Section
What special precautions should I follow? (MedlinePlus)
Source text (exact source wording)
you should know the following nonprescription or herbal products may interact with tramadol: St. John's wort and tryptophan.
Liverpool checkers
not applicable: the label's interaction table lists ritonavir only as an example of a CYP3A4 protease inhibitor; the label has no dedicated antiviral interaction section, so the Liverpool checkers were not checked.

Patient tips

Take it exactly as prescribed and do not stop suddenly without talking to your doctor. Do not drive or run machinery until you know how it affects you. Never let anyone else take your medicine, especially children. Use a take-back program for unused tablets instead of flushing them. Call your doctor right away for slowed breathing, long pauses between breaths or shortness of breath.
Medlineplus source
MedlinePlus (https://medlineplus.gov/druginfo/meds/a695011.html)
Medlineplus source text (exact source wording)
Take tramadol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Do not stop taking tramadol without talking to your doctor. Your doctor may decrease your dose gradually. you should know that this medication may make you drowsy and may affect your coordination. Do not drive a car or operate machinery until you know how this medication affects you. Do not allow anyone else to take your medication. Tramadol may harm or cause death to other people who take your medication, especially children. Do not flush this medication down the toilet. Use a medicine take-back program.

Alternatives

Class per label
opioid agonist
Source
DailyMed label (Amneal) Highlights; MedlinePlus: 'Tramadol is in a class of medications called opiate (narcotic) analgesics.'

Frequently asked questions

Question
What is tramadol used for?
Answer
In adults it is used for pain severe enough to need an opioid pain medicine when other treatments are inadequate.
Source section
1 Indications and Usage
Source
DailyMed label (Amneal)
Question
Can I take tramadol with alcohol?
Answer
The label warns that using opioids with alcohol or other central nervous system depressants may cause profound sedation, slowed breathing, coma and death.
Source section
Boxed Warning; 7 Drug Interactions
Source
DailyMed label (Amneal)
Question
What should I do if I miss a dose?
Answer
If your doctor told you to take it regularly, take the 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.
Source section
What should I do if I forget a dose?
Source
MedlinePlus
Question
What are the most common side effects?
Answer
In clinical trials, side effects in 15% or more of patients were dizziness or vertigo, nausea, constipation, headache, sleepiness, vomiting and itching.
Source section
Highlights, Adverse Reactions
Source
DailyMed label (Amneal)
Question
Is tramadol safe in pregnancy or while breastfeeding?
Answer
Long-term use in pregnancy may cause withdrawal in the newborn, and it is not recommended during or just before labor. Breastfeeding is not recommended during treatment.
Source section
8.1 Pregnancy; 8.2 Lactation
Source
DailyMed label (Amneal)
Question
What medicines should I not combine with tramadol?
Answer
Do not use it with MAOIs or within 14 days of stopping one. The label also says carbamazepine and tramadol together are not recommended, and to avoid butorphanol, nalbuphine, pentazocine and buprenorphine with it. Tell your doctor about all your medicines.
Source section
4 Contraindications; 7 Drug Interactions
Source
DailyMed label (Amneal)
Question
Can I stop tramadol suddenly?
Answer
No. Do not stop suddenly or lower the dose quickly if you are physically dependent on opioids; the dose should be lowered gradually with your doctor.
Source section
5.18 Withdrawal
Source
DailyMed label (Amneal)
Question
What should I do in an overdose?
Answer
Call poison control at 1-800-222-1222. If the person has collapsed, had a seizure, has trouble breathing or cannot be woken, call 911.
Source section
In case of emergency/overdose
Source
MedlinePlus

Sources

  • DailyMed label, Tramadol Hydrochloride tablets, Amneal Pharmaceuticals NY LLC (PRIMARY)
    Set id: 8ec4e4e5-a56e-4198-8428-6b770b9bf27d · Label effective or revised date: Revised: 6/2026 · Dailymed version date: Sep 18, 2026 (DailyMed published date) · Fetched at: 2026-11-02 · Sections used: Highlights, Boxed Warning, 1, 2, 3, 4, 5.1-5.21 (excerpts), 6, 7, 8, 10, 12.1, 16
  • MedlinePlus Tramadol
    Set id: n/a · Label effective or revised date: Last Revised - 09/15/2026 · Fetched at: 2026-11-02 · Sections used: forget a dose, side effects, overdose, precautions, storage, brand names
  • openFDA label API (pharm class query)
    Set id: n/a · Label effective or revised date: n/a · Fetched at: 2026-11-02 · Sections used: none (returned NOT_FOUND 'Nothing to count')
  • Drugs@FDA
    Set id: n/a · Label effective or revised date: n/a · Fetched at: 2026-11-02 · Sections used: NOT FOUND (not reachable in this run)

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