Bismuth Subsalicylate
Active ingredient
Sold as Bismuth · Bismutina · Kaopectate · Pepto-Bismol · Anti-Diarrheal
- Drug class
- -
- Availability
- Over-the-counter
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 58
- FDA reports (12 mo)
- 321
Overview
Plain-language summary, compiled from the cited regulatory records
Bismuth subsalicylate is an active ingredient used to relieve symptoms associated with diarrhea and upset stomach [1]. It is formulated to address issues arising from overindulgence in food and drink, including heartburn, indigestion, nausea, gas, belching, and feelings of fullness [1]. This ingredient is available under various brand names, such as Pepto-Bismol and Bismuth [1].
In the past 12 months, there have been 321 adverse event reports associated with this ingredient [2]. The most frequently reported reactions include diarrhea, nausea, vomiting, off-label use, and fatigue [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 31 | April 8, 2026 |
| GB United Kingdom | MHRA | 3 | April 17, 2026 |
| CA Canada | Health Canada | 24 | April 16, 2025 |
USUnited States· FDA
31 products
Uses
Uses relieves travelers’ diarrhea diarrhea upset stomach due to overindulgence in food and drink including: heartburn indigestion nausea gas belching fullness
How to take
GBUnited Kingdom· MHRA
3 products
Uses
Indicated in adults and adolescents aged 16 or over for the symptomatic relief of the relief of indigestion, dyspepsia, nausea, upset stomach (due to overindulgence in food and drink) and diarrhoea.
How to take
CACanada· Health Canada
24 products
24 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Drug interactions
Known interactions involving Bismuth Subsalicylate. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]FDA DailyMed · 015ca07a-f6b5-47… · revised November 7, 2018 [PDF]
- [2]MHRA (UK) · PL000140615 · revised April 17, 2026
- [3]Health Canada (DPD) · 02097079 · revised March 22, 2025
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.