Age Restrictions for Pepto Bismol (Bismuth Subsalicylate) in Children
Pepto Bismol (bismuth subsalicylate) should not be given to children under 12 years of age. 1
FDA-Approved Usage
The FDA-approved drug labeling clearly states that Pepto Bismol is only approved for:
- Adults and children 12 years and over
- For children under 12 years: "ask a doctor" 1
Reason for Age Restriction: Reye's Syndrome Risk
The primary concern with bismuth subsalicylate in children is the salicylate component, which is chemically related to aspirin. This creates a significant risk for:
- Reye's syndrome: A rare but serious condition that can occur when children and teenagers with viral infections (like flu or chickenpox) take medications containing salicylates 2
- This risk is explicitly mentioned in clinical guidelines, which state: "Aspirin or aspirin-containing products (e.g. bismuth subsalicylate [Pepto Bismol]) should not be administered to any person aged ≤18 years with suspected influenza because of the risk for Reye's syndrome" 2
Pharmacology and Safety Considerations
When bismuth subsalicylate is ingested:
- Over 90% of the salicylate portion is absorbed into the bloodstream 3
- Less than 0.005% of the bismuth component is absorbed 3
While the bismuth component has an excellent safety profile with low bioavailability (less than 1%), the salicylate component presents the primary risk in children 4.
Alternative Options for Children Under 12
For children under 12 years with digestive complaints:
- Use other antipyretic medications (e.g., acetaminophen) for fever relief 2
- Children under 4 years should not receive any over-the-counter cold medications without healthcare provider consultation 2
- Focus on adequate hydration with clear fluids to prevent dehydration from diarrhea 1
Special Considerations
- Viral infections: The risk of Reye's syndrome is particularly high when bismuth subsalicylate is given to children with viral infections like influenza or chickenpox 2, 5
- Prolonged use: Extended use can lead to bismuth accumulation, which may take up to 3 months to be fully excreted 4
- Toxicity: Rare cases of bismuth toxicity have been reported with prolonged, excessive use, causing neurological symptoms 6
Bottom Line
For gastrointestinal symptoms in children under 12 years of age, consult with a healthcare provider for appropriate treatment options instead of using Pepto Bismol. The risk of Reye's syndrome outweighs the potential benefits in this age group.