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Olsalazine Pregnancy and Breastfeeding Warnings

Olsalazine is also known as: Dipentum

Medically reviewed on Dec 17, 2018

Olsalazine Pregnancy Warnings

Animal studies showed fetal developmental toxicity (reduced fetal weights, retarded ossifications, immaturity of fetal visceral organs) when given during organogenesis at doses 5 to 20 times the human dose. 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

Olsalazine Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug; benefit to mother should outweigh risk to the infant.

Excreted into human milk: Yes

-Small amounts of the active metabolite (5-ASA) may pass into breast milk.
-Diarrhea in the infant has been reported when 5-ASA was used during breast feeding.
-An animal study giving 5 to 20 times the human dose to lactating rats resulted in growth retardation in the pups.

See references

References for pregnancy information

  1. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL:" ([1999]):
  2. "Product Information. Dipentum (olsalazine)." Meda Pharmaceuticals, Somerset, NJ.

References for breastfeeding information

  1. "Product Information. Dipentum (olsalazine)." Meda Pharmaceuticals, Somerset, NJ.

Further information

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