Drug side effects
tramadol Side Effects
The reactions most often reported to the FDA for tramadol (also sold as Ultram, ConZip), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 36,174
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 1997 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of tramadol come from 36,174 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 36,174 reports to the FDA Adverse Event Reporting System (FAERS) for tramadol (Ultram): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
36,174
Reports Mentioning Death
6,870
19.0% of reports — not proof the medicine caused the death
Hospitalizations
11,220
31.0% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 6,870 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 1,793 |
| VOMITING | 1,219 |
| TYPE 2 DIABETES MELLITUS | 1,048 |
| FATIGUE | 1,044 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,042 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,040 |
| PSORIATIC ARTHROPATHY | 1,016 |
| WOUND | 1,016 |
| INFUSION RELATED REACTION | 1,015 |
| SYNOVITIS | 1,015 |
| OVERDOSE | 1,009 |
| RASH | 996 |
| RHEUMATOID ARTHRITIS | 989 |
| HYPOAESTHESIA | 986 |
| JOINT SWELLING | 971 |
| FOLLICULITIS | 962 |
| ARTHRALGIA | 958 |
| IRRITABLE BOWEL SYNDROME | 957 |
| DIARRHOEA | 955 |
Reactions in Hospitalization Reports
Top reactions in 11,220 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| VOMITING | 1,522 |
| NAUSEA | 1,279 |
| HYPERTENSION | 1,268 |
| FATIGUE | 1,220 |
| CONFUSIONAL STATE | 1,186 |
| PAIN | 1,160 |
| HEADACHE | 1,158 |
| RASH | 1,113 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,064 |
| DIARRHOEA | 1,047 |
| DIZZINESS | 1,042 |
| ARTHRALGIA | 1,017 |
| RHEUMATOID ARTHRITIS | 1,016 |
| INFUSION RELATED REACTION | 1,001 |
| HYPOAESTHESIA | 994 |
| DYSPNOEA | 993 |
| SYNOVITIS | 977 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 973 |
Nearby, Related Medications
What the FAERS Data Reveals About tramadol Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 36,174 voluntary reports linked to tramadol and its brand equivalents (Ultram, ConZip), spanning 1997 through 2025. Of those, 6,870 (19.0%) listed death as an outcome and 11,220 (31.0%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 60% were female and 39% male; age distribution skews toward 18-44, with 5,980 reports in that bracket. The single most reported reaction is dependence with 7,820 submissions, followed by overdose and vomiting.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to tramadol's 36,174.
Read our methodology - how this data is sourced, computed, and verified.