Animal studies at 2.4 and 4.7 times the recommended human dose showed no evidence of fetal harm or impaired fertility. There are no controlled data in human pregnancy. Mesalamine, a metabolite of this drug, is known to cross the placental barrier.

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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should be used during pregnancy only if clearly needed.

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

See references

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

See references