This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: C

Comments:
-This medication may cause respiratory depression in newborn infants.
-Do not give at, or near, term.

Animal studies showed effects on fertility and decreased maternal weight at 50 times the human dose; a small animal study did not show embryotoxicity, fetotoxicity, or teratogenic effects. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Caution is recommended.

Excreted into human milk: Yes


Comments:
-Atropine is excreted in breast milk.
-The major metabolite of diphenoxylate (diphenoxylic acid) may be excreted in breast milk.
-Infants of nursing mothers taking this medication may exhibit some of the side effects of the drug.

See references