sulindac Side Effects
Also known as: Clinoril
Analysis of 2,380 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
2,380
Death-Related
132
5.5% of reports
Hospitalizations
620
26.1% 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 132 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 39 |
| CARDIAC ARREST | 12 |
| TOXICITY TO VARIOUS AGENTS | 11 |
| SEPSIS | 9 |
| PULMONARY EMBOLISM | 8 |
| RENAL FAILURE | 8 |
| ACUTE KIDNEY INJURY | 7 |
| CARDIO-RESPIRATORY ARREST | 7 |
| CHRONIC KIDNEY DISEASE | 7 |
| DRUG INTERACTION | 6 |
| HEPATIC CIRRHOSIS | 6 |
| RENAL IMPAIRMENT | 6 |
| RESPIRATORY ARREST | 6 |
| COMPLETED SUICIDE | 5 |
| PANCYTOPENIA | 5 |
| RESPIRATORY FAILURE | 5 |
| CARDIAC FAILURE CONGESTIVE | 4 |
| END STAGE RENAL DISEASE | 4 |
| HAEMATEMESIS | 4 |
| LOSS OF CONSCIOUSNESS | 4 |
Reactions in Hospitalization Reports
Top reactions in 620 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FALL | 47 |
| PAIN | 47 |
| FATIGUE | 45 |
| ASTHENIA | 42 |
| NAUSEA | 38 |
| DIARRHOEA | 37 |
| DYSPNOEA | 37 |
| ARTHRALGIA | 36 |
| PNEUMONIA | 36 |
| DIZZINESS | 34 |
| BACK PAIN | 33 |
| DRUG INEFFECTIVE | 33 |
| VOMITING | 33 |
| CONSTIPATION | 29 |
| ABDOMINAL PAIN | 28 |
| PAIN IN EXTREMITY | 28 |
| WEIGHT DECREASED | 28 |
| ACUTE KIDNEY INJURY | 27 |
| RENAL FAILURE | 27 |
| DEPRESSION | 25 |
Nearby — Related Medications
What the FAERS Data Reveals About sulindac Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 2,380 voluntary reports linked to sulindac and its brand equivalents (Clinoril), spanning 2004 through 2025. Of those, 132 (5.5%) listed death as an outcome and 620 (26.1%) 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, 70% were female and 30% male; age distribution skews toward 45-64, with 746 reports in that bracket. The single most reported reaction is drug ineffective with 213 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.