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Bismuth subsalicylate Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Mar 6, 2023.

Bismuth subsalicylate is also known as: Bismarex, Bismatrol, Bismatrol Maximum Strength, Childrens Kaopectate, K-Pek, Kao-Tin Bismuth Subsalicylate Formula, Kaopectate, Kaopectate Anti-Diarrheal Upset Stomach Reliever, Kaopectate Extra Strength, Kapectolin (New Formula), Kola-Pectin DS, Maalox Total Relief, Maximum Strength Stress, Peptic Relief, Pepto-Bismol, Pepto-Bismol InstaCool, Pepto-Bismol Maximum Strength, Pepto-Bismol Original Strength, Percy Medicine, Pink Bismuth, Soothe Caplets, Stomach Relief, Stress Maximum Strength

Bismuth subsalicylate Pregnancy Warnings

Safety has not been established during pregnancy; use is not recommended.

US FDA pregnancy category: Not assigned

Animal studies are inadequate. There are no controlled data in human pregnancy. Bismuth subsalicylate lacks reports of adverse fetal outcomes; however salicylates may cause congenital defects, increased perinatal mortality from ductus arteriosus in utero, intrauterine growth restriction, and salicylate intoxication.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Bismuth subsalicylate Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Yes

-Bismuth is not expected to appear in high concentrations in breast milk due to poor systemic absorption.
-Salicylates are excreted in breast milk.

See references

References for pregnancy information

  1. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation." Baltimore, MD: Williams & Wilkins (1998):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Briggs GG, Yaffe SJ., Freeman RK "Drugs in Pregnancy and Lactation." Philadelphia, PA: Llippincott Williams & Wilkins (2011):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.