diclofenac Side Effects
Also known as: Voltaren, Cataflam
Analysis of 82,165 adverse event reports submitted to the FDA from 2001 to 2025.
Total Reports
82,165
Death-Related
10,052
12.2% of reports
Hospitalizations
30,047
36.6% 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 10,052 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| OFF LABEL USE | 2,418 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 2,274 |
| RHEUMATOID ARTHRITIS | 2,257 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 2,257 |
| FATIGUE | 2,248 |
| GLOSSODYNIA | 2,230 |
| RASH | 2,226 |
| HYPERTENSION | 2,224 |
| JOINT SWELLING | 2,208 |
| INFUSION RELATED REACTION | 2,194 |
| TYPE 2 DIABETES MELLITUS | 2,188 |
| HEPATIC ENZYME INCREASED | 2,186 |
| HAND DEFORMITY | 2,175 |
| HYPOAESTHESIA | 2,170 |
| PSORIATIC ARTHROPATHY | 2,128 |
| PAIN | 2,121 |
| WOUND | 2,104 |
| PEMPHIGUS | 2,100 |
| DUODENAL ULCER PERFORATION | 2,099 |
| FIBROMYALGIA | 2,098 |
Reactions in Hospitalization Reports
Top reactions in 30,047 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FATIGUE | 4,087 |
| PAIN | 3,989 |
| VOMITING | 3,727 |
| ARTHRALGIA | 3,709 |
| OFF LABEL USE | 3,619 |
| DRUG INEFFECTIVE | 3,361 |
| NAUSEA | 3,349 |
| DYSPNOEA | 3,338 |
| ABDOMINAL DISCOMFORT | 3,311 |
| RASH | 3,263 |
| RHEUMATOID ARTHRITIS | 3,234 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 3,127 |
| JOINT SWELLING | 3,101 |
| DIARRHOEA | 3,080 |
| CONDITION AGGRAVATED | 3,073 |
| HEADACHE | 3,039 |
| PYREXIA | 3,039 |
| SWELLING | 3,037 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 3,026 |
| ARTHROPATHY | 2,950 |
Nearby — Related Medications
What the FAERS Data Reveals About diclofenac Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 82,165 voluntary reports linked to diclofenac and its brand equivalents (Voltaren, Cataflam), spanning 2001 through 2025. Of those, 10,052 (12.2%) listed death as an outcome and 30,047 (36.6%) 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, 68% were female and 32% male; age distribution skews toward 45-64, with 19,381 reports in that bracket. The single most reported reaction is drug ineffective with 13,688 submissions, followed by pain and fatigue.
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.