Pharmacology Explained: Why is Pepto-Bismol banned in Europe?

October 6, 2025 •

2 min read

Between 1973 and 1980, around 1,000 cases of bismuth-related neurotoxicity were reported in France alone, leading to a significant shift in regulatory attitudes. This historical context is key to understanding why is Pepto-Bismol banned in Europe, or at least heavily restricted, unlike its over-the-counter status in the U.S.

Quick Summary

Pepto-Bismol's availability in Europe is limited primarily due to its active ingredient, bismuth subsalicylate. Concerns stem from historical bismuth neurotoxicity events and the salicylate component's link to Reye's syndrome, a serious illness in children.

Key Points

Bismuth Neurotoxicity: Historical cases in France linked to other bismuth compounds led to very strict regulations on bismuth levels in medications.
Salicylate & Reye's Syndrome: The active ingredient's salicylate component is linked to Reye's Syndrome in children recovering from viruses.
Precautionary Principle: Many European regulators restrict substances with potential for harm, even if the risk is low.
Not a Total Ban: The substance is heavily restricted or unavailable in many EU countries but is sold with regulations in the UK.
Different Philosophies: The EU's cautious approach contrasts with the U.S. model, which often focuses on managing safe dosages.
Targeted Alternatives: European pharmacies offer specific medications for individual symptoms rather than a single equivalent product.
Active Ingredient is Key: Restrictions stem from the active ingredient, bismuth subsalicylate, not solely the brand name Pepto-Bismol.

The Core of the Concern: Bismuth Subsalicylate

Pepto-Bismol, popular in the U.S. for digestive issues, contains bismuth subsalicylate, which breaks down into bismuth and salicylic acid in the body. European regulators have concerns regarding both components.

Bismuth and Neurotoxicity

Historical events in France during the 1970s involving bismuth-related neurotoxicity, with approximately 1,000 reported cases and 72 deaths, contributed to strict regulations on bismuth levels in medications. Although bismuth subsalicylate is considered less likely to cause such issues than other bismuth salts, the historical precedent remains a factor in countries like France restricting high bismuth levels.

Salicylate and Reye's Syndrome

A more widespread concern is the salicylate component, similar to the active ingredient in aspirin. The use of salicylates in children and teenagers recovering from viral illnesses has been linked to Reye's syndrome. This rare but serious condition causes swelling in the liver and brain. Consequently, many health authorities advise against using Pepto-Bismol in this age group during or after viral infections to minimize the risk.

Regulatory Differences: A Tale of Two Continents

The differing availability of Pepto-Bismol highlights distinct regulatory approaches. The European Union often follows a 'precautionary principle,' restricting substances with potential harm even at low risk. This has resulted in bans or limited availability in various European countries. In contrast, U.S. regulation may focus more on establishing safe dosage levels for over-the-counter drugs. It's worth noting that Pepto-Bismol is not universally banned in Europe; in the UK, it is available but regulated.

European Alternatives to Pepto-Bismol

Travelers in Europe won't find a direct equivalent to Pepto-Bismol. Instead, European pharmacies offer symptom-specific treatments. Consulting a pharmacist is recommended for personalized advice.


Symptom	Common European Alternatives	Active Ingredient(s)	Countries
Diarrhea	Imodium, Arret	Loperamide	Widely available
Heartburn / Indigestion	Gaviscon, Rennie, Maalox	Alginates, Calcium Carbonate, Magnesium Carbonate	Widely available
Nausea / Vomiting	Motilium, Domerid	Domperidone	Prescription or pharmacist-only in many areas
General Upset Stomach	Biochetasi, Geffer	Citrates, Sodium Bicarbonate, Metoclopramide	Primarily Italy

Conclusion

The availability of Pepto-Bismol in Europe is restricted due to concerns about its active ingredient, bismuth subsalicylate. These concerns are rooted in historical bismuth neurotoxicity and the link between salicylates and Reye's syndrome in children. European regulators often adopt a precautionary principle, leading to varied restrictions across the continent. Travelers should be prepared to seek symptom-specific remedies available in local pharmacies.

For more information on the use of bismuth subsalicylate in the UK, consult the NHS website.

Frequently Asked Questions

The main active ingredient in Pepto-Bismol is bismuth subsalicylate, which acts as an antacid and anti-inflammatory agent.

France imposed strict regulations on bismuth-containing medications following a health scare in the 1970s involving bismuth-related neurotoxicity cases.

Reye's syndrome is a rare but serious illness affecting the brain and liver, primarily in children and teens recovering from viruses. It is linked to salicylate use, including the bismuth subsalicylate in Pepto-Bismol.

Yes, Pepto-Bismol is available in the UK from pharmacies, although it is regulated and some forms might not be available.

Yes, aspirin (acetylsalicylic acid) is a common product containing salicylate. Salicylates are also found in other medications and topical products.

A widely available over-the-counter alternative for diarrhea in Europe is Imodium, which contains loperamide.

While high-dose, long-term use of bismuth compounds has been linked to neurotoxicity, Pepto-Bismol is generally considered safe for adults when used as directed, with a low risk of toxicity from occasional use. Restrictions in Europe are largely due to the salicylate component and the precautionary principle.