nabumetone Side Effects
Also known as: Relafen
Analysis of 6,319 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
6,319
Death-Related
360
5.7% of reports
Hospitalizations
1,504
23.8% 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 360 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 89 |
| COMPLETED SUICIDE | 77 |
| TOXICITY TO VARIOUS AGENTS | 39 |
| PNEUMONIA | 35 |
| ACUTE KIDNEY INJURY | 31 |
| CARDIAC ARREST | 29 |
| RENAL FAILURE | 29 |
| CARDIO-RESPIRATORY ARREST | 27 |
| SEPSIS | 26 |
| PAIN | 25 |
| RESPIRATORY ARREST | 24 |
| CARDIAC FAILURE CONGESTIVE | 23 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 21 |
| BLOOD CREATININE INCREASED | 20 |
| NAUSEA | 20 |
| JAUNDICE | 19 |
| MYOCARDIAL INFARCTION | 19 |
| PLEURAL EFFUSION | 18 |
| CHRONIC KIDNEY DISEASE | 17 |
| DISSEMINATED INTRAVASCULAR COAGULATION | 17 |
Reactions in Hospitalization Reports
Top reactions in 1,504 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| PNEUMONIA | 124 |
| PAIN | 119 |
| DYSPNOEA | 113 |
| NAUSEA | 105 |
| FALL | 101 |
| ACUTE KIDNEY INJURY | 97 |
| ANXIETY | 95 |
| DEPRESSION | 84 |
| FATIGUE | 84 |
| BACK PAIN | 77 |
| ARTHRALGIA | 75 |
| DIARRHOEA | 74 |
| HEADACHE | 74 |
| ASTHENIA | 73 |
| CHEST PAIN | 72 |
| VOMITING | 72 |
| PAIN IN EXTREMITY | 68 |
| DIZZINESS | 67 |
| RENAL FAILURE | 67 |
| DRUG INEFFECTIVE | 63 |
Nearby — Related Medications
What the FAERS Data Reveals About nabumetone Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 6,319 voluntary reports linked to nabumetone and its brand equivalents (Relafen), spanning 2004 through 2025. Of those, 360 (5.7%) listed death as an outcome and 1,504 (23.8%) 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, 74% were female and 26% male; age distribution skews toward 45-64, with 1,956 reports in that bracket. The single most reported reaction is drug ineffective with 500 submissions, followed by pain and nausea.
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.