Is Peptobismol (bismuth subsalicylate) safe for a 1-year-old child?

Pepto-Bismol is Contraindicated in a 1-Year-Old Child

Pepto-Bismol (bismuth subsalicylate) should NOT be given to a 1-year-old child under any circumstances due to the risk of Reye's syndrome and documented cases of salicylate toxicity in infants. 1, 2, 3

Why This is Dangerous

Reye's Syndrome Risk

• The CDC and ACIP explicitly state that aspirin or aspirin-containing products, including bismuth subsalicylate, should not be administered to any person aged ≤18 years with suspected influenza due to the risk of Reye's syndrome—a rare but potentially fatal illness. 1, 2
• The FDA drug label for bismuth subsalicylate specifically warns that "children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product." 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. 1, 2

Documented Salicylate Toxicity in Infants

• A published case report documented severe salicylate toxicity in a 3-month-old infant who received bismuth subsalicylate (Percy Medicine) for colic, resulting in metabolic acidosis, CNS depression, respiratory distress, and a serum salicylate concentration of 747 mg/L requiring PICU admission. 4
• The infant in this case received the equivalent of aspirin 57-84 mg/kg/day for 3.5 weeks before presenting with life-threatening toxicity. 4
• This demonstrates that even "routine" dosing of bismuth subsalicylate can cause serious harm in young children. 4

Additional Contraindications for Diarrhea

• Antimotility drugs, including bismuth subsalicylate, should not be given to children <18 years of age with acute diarrhea. 2
• Oral rehydration therapy is the primary treatment for diarrhea in children, not bismuth products. 2

Safe Alternatives for a 1-Year-Old

For Fever or Pain

• Acetaminophen or ibuprofen (NSAIDs) are the recommended safe alternatives for fever relief in children. 1, 2

For Diarrhea

• Oral rehydration therapy is the primary treatment. 2
• Ondansetron may be considered for children >4 years of age with significant vomiting to facilitate oral rehydration (note: your 1-year-old is too young for this). 2

Critical Clinical Pitfall

Parents may assume over-the-counter products are safe because they don't require a prescription, and packaging with pictures of babies can mislead caregivers into thinking products are appropriate for infants. 4 Healthcare providers must explicitly educate families that bismuth subsalicylate is dangerous for all children, especially those under 2 years of age.