LOW-VOLUME · HOSP-MID
bismuth subsalicylate Side Effects
bismuth subsalicylate (also sold as Pepto-Bismol) is a LOW-VOLUME FAERS extract #386 of 524 by FAERS report count. Still opens on HOSP-MID: 26.5% mention hospitalization (1,477 reports).
Data updated 2026-05-15
- 5,567
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
bismuth subsalicylate: 26.5% mention hospitalization (1,477 reports). Death stamp DEATH-HEAVY; volume band LOW-VOLUME #386 of 524 by FAERS report count.
Thinner FAERS extract for bismuth subsalicylate (Pepto-Bismol) (5,567 reports #386 of 524 by FAERS report count). 26.5% mention hospitalization (1,477 reports). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2004–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
CHRONIC KIDNEY DISEASE leads 1,418 of 5,567 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (1,288 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (516 reports, 9.3%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 182 |
| CHRONIC KIDNEY DISEASE | 150 |
| END STAGE RENAL DISEASE | 130 |
| ACUTE KIDNEY INJURY | 120 |
| RENAL FAILURE | 98 |
| NAUSEA | 91 |
| VOMITING | 87 |
| ABDOMINAL DISTENSION | 77 |
| ABDOMINAL PAIN | 75 |
| SEPSIS | 73 |
| CONSTIPATION | 72 |
| ASCITES | 70 |
| VENTRICULAR FIBRILLATION | 70 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 68 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 67 |
| APPENDICITIS | 65 |
| CONDITION AGGRAVATED | 65 |
| HYPONATRAEMIA | 65 |
| SOMNOLENCE | 65 |
Reactions in Hospitalization Reports
Hospitalization mid-share (1,477, 26.5%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| NAUSEA | 227 |
| DIARRHOEA | 202 |
| VOMITING | 198 |
| CHRONIC KIDNEY DISEASE | 197 |
| ACUTE KIDNEY INJURY | 196 |
| RENAL FAILURE | 167 |
| OSTEOPOROSIS | 140 |
| ABDOMINAL PAIN | 136 |
| DYSPNOEA | 132 |
| FALL | 121 |
| DEPRESSION | 120 |
| END STAGE RENAL DISEASE | 116 |
| PAIN | 111 |
| FATIGUE | 109 |
| CONSTIPATION | 107 |
| ARTHRITIS | 105 |
| ASTHENIA | 99 |
| ANXIETY | 90 |
| ABDOMINAL DISTENSION | 86 |
How to read bismuth subsalicylate FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-MID)
FAERS holds 5,567 voluntary reports linked to bismuth subsalicylate (Pepto-Bismol), 2004-2025. Death is listed on 516 (9.3%). Hospitalization appears on 1,477 (26.5%). Top co-reported indication: Gastrooesophageal Reflux Disease.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with bismuth subsalicylate
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 5,503 FAERS cases (Δ 64 lighter vs bismuth subsalicylate); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 5,460 FAERS cases (Δ 107 lighter vs bismuth subsalicylate); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 5,762 FAERS cases (Δ 195 heavier vs bismuth subsalicylate); DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 5,766 FAERS cases (Δ 199 heavier vs bismuth subsalicylate); DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 52.8 pp vs bismuth subsalicylate's DEATH-HEAVY): CASELOAD · HOSP-MID.
bismuth subsalicylate stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.