LOW-VOLUME · SEX-BALANCED
sulindac Side Effects
sulindac (also sold as Clinoril) is a LOW-VOLUME FAERS extract #446 of 524 by FAERS report count. Still opens on SEX-BALANCED: 70% of sex-coded reports are female (1,581 F / 684 M).
Data updated 2026-05-15
- 2,380
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
sulindac reporting skew - 70% of sex-coded reports are female (1,581 F / 684 M). Volume band LOW-VOLUME #446 of 524 by FAERS report count; caseload SIGNAL.
Thinner FAERS extract for sulindac (Clinoril) (2,380 reports #446 of 524 by FAERS report count). 70% of sex-coded reports are female (1,581 F / 684 M). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2004–2025). Stamps SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
PAIN leads 182 of 2,380 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (746 reports)
Reporting taper since 2004 peak
Reactions in Death Reports
Death-mentioned subset is HEAVY here (132 reports, 5.5%). Top co-reported reactions in that subset - voluntary, not causal.
| 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
Hospitalization mid-share (620, 26.1%). Co-reported reactions:
| 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 |
| VOMITING | 33 |
| CONSTIPATION | 29 |
| ABDOMINAL PAIN | 28 |
| PAIN IN EXTREMITY | 28 |
| WEIGHT DECREASED | 28 |
| ACUTE KIDNEY INJURY | 27 |
| RENAL FAILURE | 27 |
| DEPRESSION | 25 |
How to read sulindac FAERS figures (SIGNAL · DEATH-HEAVY · HOSP-MID)
FAERS holds 2,380 voluntary reports linked to sulindac (Clinoril), 2004-2025. Death is listed on 132 (5.5%). Hospitalization appears on 620 (26.1%). Top co-reported indication: Product Used For Unknown Indication.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with sulindac
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 2,398 FAERS cases (Δ 18 heavier vs sulindac); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 2,415 FAERS cases (Δ 35 heavier vs sulindac); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 2,425 FAERS cases (Δ 45 heavier vs sulindac); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 2,439 FAERS cases (Δ 59 heavier vs sulindac); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 56.6 pp vs sulindac's DEATH-HEAVY): CASELOAD · HOSP-MID.
sulindac stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload SIGNAL and the label guide.