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

Use is not recommended.

Excreted into human milk: Yes

Comments:
-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