Pepto Bismol Should Not Be Used in Children Under 12 Years of Age
Pepto Bismol (bismuth subsalicylate) is contraindicated in children and teenagers aged ≤18 years who have or are recovering from influenza or varicella (chickenpox) due to the risk of Reye's syndrome, and the FDA drug label explicitly restricts use to children 12 years and older. 1
Primary Safety Concern: Reye's Syndrome
The most critical issue with bismuth subsalicylate in children is its salicylate content, which creates a well-established risk:
The CDC and ACIP explicitly state that aspirin or aspirin-containing products, including bismuth subsalicylate, should not be given to any person aged ≤18 years with suspected influenza due to Reye's syndrome risk 2, 3
The American Academy of Dermatology confirms that salicylates in children with varicella infection or influenza-like illnesses are associated with increased risk of developing Reye syndrome 2, 3
The FDA drug label warns that children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product, noting that changes in behavior with nausea and vomiting could be early signs of Reye's syndrome 1
FDA-Approved Age Restrictions
The official FDA labeling provides clear guidance:
- Children under 12 years: ask a doctor 1
- Adults and children 12 years and over: approved for use with specific dosing (2 chewable tablets every 1/2 hour or 4 chewable tablets every hour as needed) 1
Recommended Safe Alternatives
For symptom management in children, safer options exist:
For Fever Relief:
- The American Academy of Pediatrics recommends acetaminophen or NSAIDs (like ibuprofen) as safe alternatives for fever relief in children 2, 3
For Diarrhea:
- Antimotility drugs (including bismuth subsalicylate) should not be given to children <18 years of age with acute diarrhea 2
- Focus on oral rehydration therapy as the primary treatment for diarrhea in children 2
- Ondansetron may be considered for children >4 years of age with significant vomiting to facilitate oral rehydration 2
Clinical Context and Nuances
While research studies have demonstrated that bismuth subsalicylate can be effective and safe in controlled settings for treating acute diarrhea in children 4, 5, these findings do not override the critical safety concerns:
Despite research showing effectiveness in shortening diarrheal illness duration, limited effectiveness and concerns about Reye syndrome, compliance, and cost are key reasons it is not routinely recommended for children 6
Studies showing safety used careful monitoring of salicylate and bismuth levels in controlled hospital settings 4, which is not feasible in typical outpatient use
The risk-benefit calculation changes dramatically when viral illnesses (influenza, varicella) are present or cannot be ruled out, making the blanket restriction appropriate for real-world clinical practice 2, 3, 1
Common Pitfalls to Avoid
Do not assume that over-the-counter availability means safety for all ages - the FDA label clearly restricts use in children under 12 1
Do not use bismuth subsalicylate in any child with fever or viral symptoms where influenza or varicella cannot be definitively excluded 2, 3, 1
Avoid the temptation to use research data from controlled trials to justify routine clinical use - the guideline restrictions exist precisely because real-world conditions differ from research protocols 2, 3, 6