Drug side effects
bismuth subsalicylate Side Effects
The reactions most often reported to the FDA for bismuth subsalicylate (also sold as Pepto-Bismol), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 5,567
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of bismuth subsalicylate come from 5,567 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 5,567 reports to the FDA Adverse Event Reporting System (FAERS) for bismuth subsalicylate (Pepto-Bismol): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
5,567
Reports Mentioning Death
516
9.3% of reports — not proof the medicine caused the death
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 |
| 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 |
| 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.
How to read these numbers
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to bismuth subsalicylate's 5,567.
Read our methodology - how this data is sourced, computed, and verified.