bismuth subsalicylate Side Effects
Also known as: Pepto-Bismol
Analysis of 5,567 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
5,567
Death-Related
516
9.3% of reports
Hospitalizations
1,477
26.5% of reports
Top Indication
Gastrooesophageal Reflux Disease
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 516 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| 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 |
| OFF LABEL USE | 73 |
| 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
Top reactions in 1,477 reports where hospitalization was an outcome.
| 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 |
| OFF LABEL USE | 89 |
| ABDOMINAL DISTENSION | 86 |
Nearby — Related Medications
What the FAERS Data Reveals About bismuth subsalicylate Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 5,567 voluntary reports linked to bismuth subsalicylate and its brand equivalents (Pepto-Bismol), spanning 2004 through 2025. Of those, 516 (9.3%) listed death as an outcome and 1,477 (26.5%) involved hospitalization. The most common indication reported alongside adverse events was Gastrooesophageal Reflux Disease.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 62% were female and 38% male; age distribution skews toward 45-64, with 1,288 reports in that bracket. The single most reported reaction is chronic kidney disease with 1,418 submissions, followed by acute kidney injury and renal failure.
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.