diflunisal Side Effects
Also known as: Dolobid
Analysis of 799 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
799
Death-Related
66
8.3% of reports
Hospitalizations
236
29.5% 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 66 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 25 |
| DEATH | 13 |
| CARDIAC ARREST | 10 |
| CARDIO-RESPIRATORY ARREST | 7 |
| RESPIRATORY ARREST | 7 |
| TOXICITY TO VARIOUS AGENTS | 5 |
| CARDIAC FAILURE | 4 |
| EYE DISORDER | 4 |
| PNEUMONIA | 4 |
| RASH | 4 |
| RESPIRATORY DISORDER | 4 |
| TOXIC EPIDERMAL NECROLYSIS | 4 |
| CONDITION AGGRAVATED | 3 |
| DRUG INEFFECTIVE | 3 |
| FALL | 3 |
| GASTROINTESTINAL HAEMORRHAGE | 3 |
| PAIN | 3 |
| SEPSIS | 3 |
| ACUTE HEPATIC FAILURE | 2 |
| ACUTE KIDNEY INJURY | 2 |
Reactions in Hospitalization Reports
Top reactions in 236 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FALL | 21 |
| NAUSEA | 20 |
| PNEUMONIA | 19 |
| DIARRHOEA | 18 |
| PAIN | 18 |
| VOMITING | 16 |
| CHEST PAIN | 15 |
| FATIGUE | 14 |
| MALAISE | 14 |
| HEADACHE | 13 |
| PLATELET COUNT DECREASED | 13 |
| BLOOD CREATININE INCREASED | 12 |
| ARTHRALGIA | 11 |
| BACK PAIN | 11 |
| DIZZINESS | 10 |
| DRUG INEFFECTIVE | 10 |
| DYSPNOEA | 10 |
| ACUTE MYOCARDIAL INFARCTION | 9 |
| CARDIAC FAILURE | 9 |
| CARDIAC PACEMAKER INSERTION | 9 |
Nearby — Related Medications
What the FAERS Data Reveals About diflunisal Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 799 voluntary reports linked to diflunisal and its brand equivalents (Dolobid), spanning 2004 through 2025. Of those, 66 (8.3%) listed death as an outcome and 236 (29.5%) 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, 69% were female and 30% male; age distribution skews toward 45-64, with 186 reports in that bracket. The single most reported reaction is nausea with 66 submissions, followed by fatigue and pain.
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.