Prescription medication · Opioid Analgesic
tramadol
Also sold as Ultram, ConZip. Tramadol extended-release tablets are used to manage severe, long-lasting pain.
Data updated 2026-05-15
- 36,174
- FDA reportsModerately reported
- 38
- InteractionsSeveral interactions
- 1
- Recall record
What the data shows
tramadol (Ultram) is a prescription Opioid Analgesic, reported at a middle-of-the-pack volume (36,174 FDA reports), with 38 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
tramadol (Ultram) is a prescription Opioid Analgesic. Tramadol extended-release tablets are used to manage severe, long-lasting pain.
Tramadol extended-release is a strong pain medicine. It is used to treat severe, ongoing pain that needs an opioid medicine when other pain medicines don't work well enough.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$1.22/unit
Generic Available
Yes (14 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Tramadol extended-release tablets are used to manage severe, long-lasting pain.
Common side effects
Dizziness, Constipation, Feeling sick to your stomach
Key warnings
Tramadol extended-release tablets can be habit-forming, leading to addiction, abuse, and misuse, which can result in overdose and death.
The sections below are summarized in plain English from tramadol's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Tramadol works in your brain to change how your body feels pain. It binds to opioid receptors and also affects certain chemicals in the brain. This helps to lessen the pain you feel.
How to Take It
Take tramadol extended-release tablets once a day, at the same time each day. Swallow the tablets whole; do not crush, chew, or dissolve them. Your doctor will prescribe the lowest dose that works for you. Do not take more than 300 mg of tramadol in a day.
This is a plain-language summary of tramadol's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tramadol may harm your unborn baby. Breastfeeding is not recommended while taking this medicine, as it can pass into breast milk and harm your baby.
This is a plain-language summary of tramadol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of tramadol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store tramadol at room temperature, away from heat, light, and moisture, and out of reach of children.
Side Effects (from patient reports)
Based on 36,174 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for tramadol, by number of reports
- Needing the drug to function
Needing the drug to function
7,820 reports
- Taking too much of the drug
Taking too much of the drug
3,855 reports
- Throwing up
Throwing up
3,156 reports
- Discomfort 2,880
Discomfort
2,880 reports
- Feeling sick to your stomach 2,713
Feeling sick to your stomach
2,713 reports
- Pain in the head 2,265
Pain in the head
2,265 reports
- Feeling tired 2,246
Feeling tired
2,246 reports
- Difficulty breathing 2,207
Difficulty breathing
2,207 reports
- Needing the drug to function 2,161
Needing the drug to function
2,161 reports
- Allergic reaction to the drug 2,078
Allergic reaction to the drug
2,078 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for tramadol each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where tramadol sits
tramadol has more FDA adverse-event reports than 67% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is tramadol; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 36,174 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1997–2025.
Total Reports
36,174
Reports Mentioning Death
6,870
19.0% of reports — not proof of cause
Hospitalization Reports
11,220
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DEPENDENCE | 7,820 |
| 2 | OVERDOSE | 3,855 |
| 3 | VOMITING | 3,155 |
| 4 | PAIN | 2,876 |
| 5 | NAUSEA | 2,712 |
| 7 | HEADACHE | 2,264 |
| 8 | FATIGUE | 2,246 |
| 9 | DYSPNOEA | 2,207 |
| 11 | DRUG DEPENDENCE | 2,161 |
| 12 | DRUG HYPERSENSITIVITY | 2,078 |
| 13 | DIZZINESS | 1,948 |
| 14 | ARTHRALGIA | 1,926 |
| 15 | PNEUMONIA | 1,863 |
| 16 | DIARRHOEA | 1,855 |
| 17 | MALAISE | 1,845 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Tramadol extended-release tablets can be habit-forming, leading to addiction, abuse, and misuse, which can result in overdose and death. Taking tramadol with other depressants like alcohol or benzodiazepines can cause very serious side effects, including slowed breathing, coma, and death. Even one dose of tramadol can be fatal, especially in children. Using tramadol for a long time during pregnancy can cause withdrawal symptoms in the newborn.
Known Drug Interactions
7.2 Opioid Drugs Because serious, sometimes fatal reactions have been precipitated with concomitant use of opioid drugs (e.g., meperidine and its derivatives, methadone, propoxyphene, or tramadol) and MAOIs, including selective MAO-B inhibitors, concomitant use of these drugs is contraindicated [see Warnings and Precautions (5.2) ] .
Mechanism: Combining these drugs can cause a dangerous buildup of serotonin in the brain, which may lead to a life-threatening reaction.
What to do: Do not take these two medications together.
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 extended-release tablets and carbamazepine is not recommended. Examples: Rifampin, carbamazepine, phenytoin 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...
Mechanism: Carbamazepine makes your body break down the pain medicine too quickly, so it may not work. It also increases your risk of having a seizure.
What to do: You should avoid taking these two drugs together. Ask your doctor for a different way to manage your pain or seizures.
Examples: Rifampin, carbamazepine, phenytoin 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 [see Warnings and Precautions (5.3) ].
Mechanism: Rifampin speeds up the process of clearing the pain medicine from your body. This can lead to the pain medicine not working as well as it should.
What to do: Your doctor may need to adjust your dose of tramadol. Tell your healthcare provider if your pain is not being controlled.
Examples: Rifampin, carbamazepine, phenytoin 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 [see Warnings and Precautions (5.3) ].
Mechanism: Phenytoin causes your body to process and remove the pain medicine faster than usual. This means you may not get the full benefit of the pain relief.
What to do: Your doctor should monitor how well your pain is controlled. They may need to change your dosage or switch you to a different medication.
Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin) , other opioids, alcohol.
Mechanism: Both of these medicines can slow down brain activity and breathing. Taking them together increases the risk of feeling very sleepy or having trouble breathing.
What to do: Use these medicines together only if specifically directed by your doctor and watch closely for signs of extreme sleepiness.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take tramadol extended-release as needed for pain?
What should I do if I feel like the tramadol is not working anymore?
Can I drink alcohol while taking tramadol extended-release?
Is it safe for my child to take tramadol?
What are the signs of an overdose?
Can I drive while taking tramadol?
What should I tell my doctor before starting tramadol?
How do I dispose of unused tramadol?
Can tramadol cause constipation?
What if I have trouble breathing while taking tramadol?
What are the common side effects of tramadol?
Does tramadol interact with other medications?
What drug class is tramadol?
Is tramadol safe during pregnancy?
Has tramadol been recalled?
Active Recalls
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Amneal Pharmaceuticals, LLC
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for tramadol
The FDA label for tramadol (sold under brand names such as Ultram, ConZip) classifies it as a prescription-only medication in the Opioid Analgesic class. Tramadol extended-release tablets are used to manage severe, long-lasting pain. Official labeling lists 10 commonly reported side effects, including Dizziness, Constipation, Feeling sick to your stomach.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 36,174 voluntary reports. The database also lists 38 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $1.22.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: November 20, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages