tramadol Side Effects
Also known as: Ultram, ConZip
Analysis of 36,174 adverse event reports submitted to the FDA from 1997 to 2025.
Total Reports
36,174
Death-Related
6,870
19.0% of reports
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 |
| OFF LABEL USE | 1,083 |
| 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 |
| OFF LABEL USE | 1,414 |
| 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 |
| DRUG INEFFECTIVE | 1,021 |
| 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.
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.
Read our methodology — how this data is sourced, computed, and verified.