Animal studies have revealed evidence of fetotoxicity, including immaturity of fetal visceral organs, reduced fetal weights, and retarded ossifications at maternal doses 5 to 20 times the recommended human dose. There is a reported risk of stillborn or preterm birth, but without substantial risk of malformation. 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.

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

See references

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-If used during lactation, breastfed infants should be observed for side effects (e.g., diarrhea).
-Animal models given this drug during lactation produced a delay in growth in pups.

The active metabolite (5-ASA) of this drug was excreted in low amounts in breastmilk and resulted in diarrhea and other harmful effects in breastfed infants.

Oral doses 5 to 20 times the human dose given to lactating animal models produced growth retardation in pups.

See references