Last reviewed · How we verify
Pepto-Bismol (bismuth subsalicylate)
Bismuth subsalicylate (Pepto-Bismol) is a classic OTC medication for GI symptoms with over a century of use. Also a component of H. pylori quadruple therapy. Available generically.
At a glance
| Generic name | bismuth subsalicylate |
|---|---|
| Also known as | Pepto-Bismol, Kaopectate |
| Sponsor | Generic (Procter & Gamble) |
| Drug class | Bismuth [EPC] |
| Target | Cyclooxygenase |
| Modality | Inorganic salt |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 1939-01-01 (United States) |
Approved indications
- Diarrhea
- Duodenal Ulcer due to H. Pylori
- Indigestion
Common side effects
Key clinical trials
- Canadian North Helicobacter Pylori (CANHelp) Working Group Treatment Trials (Phase 4)
- Helicobacter Pylori Eradication Therapy in Portugal: Prospective, Randomized, Blind and Multicentre Trial on the Efficacy of Quadruple Therapies and Their Clinical Impact, and Immunological and Gut Mi (NA)
- Randomized Clinical Trial of Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans: "VA Eradicate HP" (Phase 3)
- Comparative Study Between Analgesic Effect of Oral Prednisolone and Oral Pregabalin in Management of Post-dural Puncture Headache in Patients Undergoing Lower Limb Surgeries (NA)
- Efficacy of One Dose of Laxative on Post-Operative Constipation Following Total Knee Arthroplasty (Phase 2)
- Actazin (Kiwifruit Extract) Versus Polyethylene Glycol 3350 for Maintenance Therapy in Children With Constipation: a Feasibility Randomized Control Trial (Phase 2)
- Comparing the Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinidazole on Rate of Eradication of Helicobacter Pylori Infected Patients on Syrian Population (Phase 4)
- Randomized, Double-blind, Placebo-controlled Trial of the Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients in Pakistan (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pepto-Bismol CI brief — competitive landscape report
- Pepto-Bismol updates RSS · CI watch RSS
- Generic (Procter & Gamble) portfolio CI