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Osilodrostat Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Apr 26, 2022.

Osilodrostat is also known as: Isturisa

Osilodrostat Pregnancy Warnings

No adverse developmental outcomes were observed in reproduction studies in pregnant rats and rabbits when exposed to this drug during organogenesis at doses that produced maternal exposures of 7 and 0.5-times the 30 mg twice daily of embryotoxicity and teratogenicity. There is no information on the effect this drug on human fertility. Animal studies have shown effects on the menstrual cycle and reduced female fertility. There are no controlled data in human pregnancy.

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.

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

US FDA pregnancy category: Not assigned.

Risk Summary: There are no available data on the use of this drug in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Comments:
-The effects on the developing fetus are unknown.
-Based on preclinical data, this drug may cause fetal harm when administered to a pregnant woman.
-It is recommended that females of childbearing potential obtain a pregnancy test before using this drug.
-Females of childbearing potential should use effective contraception during and for at least one week after treatment. If hormonal contraceptives other than the oral combination of ethynylestradiol and levonorgestrel are used, an additional barrier method of contraception is recommended.

See references

Osilodrostat Breastfeeding Warnings

Use should be avoided.

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

Comments:
-Because of the potential for serious adverse reactions (such as adrenal insufficiency) in the breastfed infant, breastfeeding is not recommended during therapy and for at least one week after.

See references

References for pregnancy information

  1. "Product Information. Isturisa (osilodrostat)." Recordati Rare Diseases Inc (2020):

References for breastfeeding information

  1. "Product Information. Isturisa (osilodrostat)." Recordati Rare Diseases Inc (2020):

Further information

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