Prescription medicine
Tramadol Brand names: Conzip; first approved as Ultram
Tramadol (Ultram) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 39 generic labelers, and pharmacies paid $0.0248 per tramadol HCl 50 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the tramadol FDA label on DailyMed (effective March 5, 2026, Lupin Pharmaceuticals, Inc.); the NDA 20281 record on Drugs@FDA; every tramadol label on DailyMed.
Highlights of the record
FDA label of March 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS.
Addiction, Abuse, and Misuse Because the use of Tramadol hydrochloride extended-release tablet 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 extended-release tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of tramadol hydrochloride extended-release tablets are essential. Instruct patients to swallow tramadol hydrochloride extended-release tablets whole to avoid exposure to a potentially fatal dose of tramadol. [see Warnings and Precautions ( 5.2 )]. Accidental Ingestion Accidental ingestion of even one dose of tramadol hydrochloride extended-release tablets, especially by children, can result in a fatal overdose of tramadol [see Warnings and Precautions ( 5.2 )]. […]
Used for
From the label: indications and usageTramadol hydrochloride extended-release tablet is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.
Forms and strengths
- 25 mg
- 50 mg
- 75 mg
- 100 mg
- 200 mg
- 300 mg
- 5 mg/ml
Extended-release tablet; coated tablet; film-coated tablet; tablet; film-coated extended-release tablet.
On the market
- Earliest approval on file
- March 3, 1995 Ultram, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 35 first June 19, 2002; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 42 of which 39 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 1, 2040 Qdolo oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0248 per tablet Tramadol HCl 50 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 8 since 2012 0 Class I among all firms' recalls; latest March 19, 2026; 2 more by firms not listed as its makers
- FAERS reports
- 37,421 through July 30, 2026
What is tramadol used for?
From the label: indications and usageTramadol hydrochloride extended-release tablet is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. […]
Conditions named in the indications of tramadol's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Opioid Agonist.
Source: FDA drug label (TRAMADOL HYDROCHLORIDE), Lupin Pharmaceuticals, Inc., effective March 5, 2026 (SPL set 46bb9ae6-3ee8-463c-badb-c7a45a89b84b), via openFDA; the full label on DailyMed
Is there a generic for tramadol (Ultram)?
The FDA approved the first generic tramadol on June 19, 2002. 35 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists tramadol from 39 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Ultram tablets; a patent listed only for Qdolo oral solution runs to September 1, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1995 earliest approval on file
- 2002 first generic approved
- 2040 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tramadol (Ultram)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0248 per Tramadol HCl 50 mg tablet, down 1% from $0.0251 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tramadol HCl 50 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tramadol HCl 100 mg tablet | Generic | $1.08 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $32.48 | +2% |
| Tramadol HCl 25 mg tablet | Generic | $3.37 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $101.00 | +5% |
| Tramadol HCl 50 mg tablet | Generic | $0.0248 per tablet | $0.744 | -1% |
| Tramadol HCl ER 100 mg capsule | Generic | $7.74 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $232.09 | +0.6% |
| Tramadol HCl ER 100 mg tablet | Generic | $0.894 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $26.83 | -15% |
| Tramadol HCl ER 200 mg capsule | Generic | $9.36 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $280.77 | +7% |
| Tramadol HCl ER 200 mg tablet | Generic | $1.25 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $37.52 | -28% |
| Tramadol HCl ER 300 mg tablet | Generic | $2.16 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $64.81 | -8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has tramadol been recalled?
The FDA's Enforcement Report lists 10 recalls naming tramadol since 2012: 0 Class I (the most serious), 8 Class II, 2 Class III; 2 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of tramadol and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 19, 2026 | Class II | Amneal Pharmaceuticals, LLC | Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval … |
| May 2, 2024 | Class II | RemedyRepack Inc. | Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol |
| April 26, 2024 | Class II | Rubicon Research Private Limited | Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol |
| June 16, 2023 | Class II | The Harvard Drug Group | Packaging defect: blister packaging inadequately sealed. |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| February 12, 2020 | Class III | Golden State Medical Supply Inc. | Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that … |
| March 19, 2018 | Class III | Lake Erie Medical & Surgical Supply Inc | Labeling: Incorrect or Missing Lot and/or Exp Date |
| February 9, 2018 | Class II | American Pharmaceutical Ingredients LLC not a listed maker | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tramadol label say about other medicines?
The tramadol label names 29 other medicines in its interaction, contraindication or warning sections. The labels of 41 other medicines name tramadol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | warnings and precautions | Risks of Concomitant Use or Discontinuation of Cytochrome P450 2D6 Inhibitors The concomitant use of tramadol hydrochloride extended-release tablets with all cytochrome P450 2D6 inhibitors (e.g., amiodarone, quinidine) may result in an increase in tramadol plasma levels and a decrease in the levels of the active … |
| Buprenorphine | drug interactions | Clinical Impact: May reduce the analgesic effect of tramadol hydrochloride extended-release tablets and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Bupropion | drug interactions | Inhibitors of CYP2D6 Clinical Impact: The concomitant use of tramadol hydrochloride extended-release tablets and CYP2D6 inhibitors may result in an increase in the plasma concentration of tramadol and a decrease in the plasma concentration of M1, particularly when an inhibitor is … depression and sedation. Examples: Quinidine, fluoxetine, paroxetine and bupropion. |
| Butorphanol | drug interactions | Clinical Impact: May reduce the analgesic effect of tramadol hydrochloride extended-release tablets and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Carbamazepine | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of tramadol hydrochloride extended-release tablets and CYP3A4 inducers can decrease the plasma concentration of tramadol, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed … syndrome, and signs of respiratory depression and sedation. Patients taking carbamazepine, a CYP3A4 inducer, may have a significantly reduced analgesic effect of tramadol. … |
| Codeine | warnings and precautions | Tramadol and codeine are subject to variability in metabolism based upon CYP2D6 genotype (described below), which can lead to increased exposure to an active metabolite. |
| Cyclobenzaprine | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … (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 … |
| Digoxin | drug interactions | Clinical Impact: Post-marketing surveillance of tramadol has revealed rare reports of digoxin toxicity. Intervention: Evaluate patients at frequent intervals for signs of digoxin toxicity and adjust the dosage of digoxin as needed. |
| Erythromycin | drug interactions | … patients at frequent intervals for signs and symptoms of opioid withdrawal. Examples Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir) CYP3A4 Inducers |
| Fluoxetine | drug interactions | Inhibitors of CYP2D6 Clinical Impact: The concomitant use of tramadol hydrochloride extended-release tablets and CYP2D6 inhibitors may result in an increase in the plasma concentration of tramadol and a decrease in the plasma concentration of M1, particularly when an inhibitor is … events including respiratory depression and sedation. Examples: Quinidine, fluoxetine, paroxetine and bupropion. |
| Gabapentin | drug interactions | Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. … anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Ketoconazole | drug interactions | … symptoms of opioid withdrawal. Examples Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir) CYP3A4 Inducers |
| Linezolid | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Metaxalone | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … 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 … |
Every other medicine the tramadol label names
| Medicine named | Section | What the label says |
|---|---|---|
| Methylene blue | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Morphine | warnings and precautions | At least one death was reported in a nursing infant who was exposed to high levels of morphine in breast milk because the mother was an ultra-rapid metabolizer of codeine. |
| Nalbuphine | drug interactions | Clinical Impact: May reduce the analgesic effect of tramadol hydrochloride extended-release tablets and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Nalmefene | warnings and precautions | Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). |
| Naloxone | warnings and precautions | Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). |
| Paroxetine | drug interactions | Inhibitors of CYP2D6 Clinical Impact: The concomitant use of tramadol hydrochloride extended-release tablets and CYP2D6 inhibitors may result in an increase in the plasma concentration of tramadol and a decrease in the plasma concentration of M1, particularly when an inhibitor is … including respiratory depression and sedation. Examples: Quinidine, fluoxetine, paroxetine and bupropion. |
| Phenelzine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). Intervention: Do not use tramadol hydrochloride extended-release tablets in patients taking MAOIs or within 14 days of stopping such treatment. Examples: phenelzine, tranylcypromine, linezolid |
| Phenytoin | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of tramadol hydrochloride extended-release tablets and CYP3A4 inducers can decrease the plasma concentration of tramadol, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed … and carbamazepine is not recommended. Examples: Rifampin, carbamazepine, phenytoin |
| Pregabalin | drug interactions | Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. … relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Promethazine | warnings and precautions | … antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), O |
| Quinidine | drug interactions | Inhibitors of CYP2D6 Clinical Impact: The concomitant use of tramadol hydrochloride extended-release tablets and CYP2D6 inhibitors may result in an increase in the plasma concentration of tramadol and a decrease in the plasma concentration of M1, particularly when an inhibitor is … for adverse events including respiratory depression and sedation. Examples: Quinidine, fluoxetine, paroxetine and bupropion. |
| Rifampin | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of tramadol hydrochloride extended-release tablets and CYP3A4 inducers can decrease the plasma concentration of tramadol, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed … extended-release tablets and carbamazepine is not recommended. Examples: Rifampin, carbamazepine, phenytoin |
| Ritonavir | drug interactions | … azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir) CYP3A4 Inducers |
| Tranylcypromine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). Intervention: Do not use tramadol hydrochloride extended-release tablets in patients taking MAOIs or within 14 days of stopping such treatment. Examples: phenelzine, tranylcypromine, linezolid |
| Warfarin | drug interactions | Clinical Impact: Post-marketing surveillance of tramadol has revealed rare reports of alteration of warfarin effect, including elevation of prothrombin times. Intervention: Frequently reevaluate the prothrombin time of patients on warfarin for signs of an interaction and adjust the dosage of warfarin as needed. … |
Other labels that name tramadol
- Acetaminophen and benzhydrocodone
- Amitriptyline
- Amphetamine
- Buprenorphine and naloxone
- Citalopram
- Clomipramine
- Cobicistat
- Darunavir
- Desipramine
- Desvenlafaxine
- Dextroamphetamine
- Duloxetine
- Escitalopram
- Fenfluramine
- Fentanyl
- Fluvoxamine
- Hydrocodone
- Hydromorphone
- Lenacapavir
- Levomilnacipran
- Levorphanol
- Lisdexamfetamine
- Lithium
- Meperidine
- Methadone
- Methamphetamine
- Milnacipran
- Mirtazapine
- Naloxone and pentazocine
- Nortriptyline
- Oliceridine
- Ondansetron
- Oxycodone
- Protriptyline
- Rasagiline
- Remifentanil
- Selegiline
- Sertraline
- Sufentanil
- Tapentadol
- Trazodone
- Trimipramine
- Venlafaxine
- Vilazodone
- Vortioxetine
- Ziprasidone
Source: FDA drug label (TRAMADOL HYDROCHLORIDE), Lupin Pharmaceuticals, Inc., effective March 5, 2026 (SPL set 46bb9ae6-3ee8-463c-badb-c7a45a89b84b), via openFDA; the full label on DailyMed
What do FAERS reports show for tramadol?
The FDA Adverse Event Reporting System holds 37,421 reports that list tramadol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,344 are coded as a death and 11,704 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2023 (9,950, against a median of 2,308 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tramadol?
35 other medicines are given the same way (oral) and in the same FDA class as tramadol or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Acetaminophen and hydrocodone | Pain | 38 labelers | $0.152 per tablet 10-325 mg tablet | No current entry |
| Oxycodone | Pain | 34 labelers | $0.0884 per tablet 5 mg tablet | No current entry |
| Acetaminophen and oxycodone | Pain | 30 labelers | $0.183 per tablet 7.5-325 mg tablet | A presentation being discontinued |
| Morphine | Pain | 17 labelers | $0.226 per tablet 15 mg tablet | In shortage |
| Acetaminophen and codeine | Pain | 25 labelers | $0.256 per tablet 3 tablet | No current entry |
| Hydromorphone | Pain | 11 labelers | $0.219 per tablet 4 mg tablet | In shortage |
| Methadone | Pain | 17 labelers | $0.177 per tablet 10 mg tablet | No current entry |
| Oxymorphone | Pain | 9 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does tramadol compare with medicines for the same use?
17 side-by-side pages set tramadol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to tramadol
- 35 medicines for the same use
- Other opioids
- the pharmacologic class, with prices and generics
- Tramadol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other