Isotretinoin Pregnancy and Breastfeeding Warnings

Brand names: Absorica, Absorica LD, Accutane, Amnesteem, Claravis, Myorisan, Sotret, Zenatane

Medically reviewed by Drugs.com. Last updated on May 2, 2025.

Isotretinoin Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: X
US FDA pregnancy categories:
-Liquid-filled capsules: X
-Capsules: Not assigned.

Risk summary: This drug can cause fetal harm when administered to a pregnant woman; life-threatening birth defects are possible at any dosage.

Comments:
-Female patients of reproductive potential should be tested for pregnancy before receiving a prescription for this drug.-Any suspected fetal exposure during or 1 month after isotretinoin therapy must be reported at once to the FDA via the MedWatch number 1-800-FDA-1088 and to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the Internet (www.ipledgeprogram.com), and patients should be referred to a healthcare provider specialized or experienced in teratology.
-Effective contraception (at least 2 reliable forms) is required during therapy and for 1 month after the last dose; local protocol should be consulted regarding contraception timing.

Severe birth defects have occurred after exposure to this drug in any dose and over any duration, even for short periods of time. There are no accurate means to determine whether an exposed fetus is affected.

AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

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.

See references

Isotretinoin Breastfeeding Warnings

Use is contraindicated.

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

Comments:
-This drug is highly lipophilic, and may be expressed into breastmilk.
-The effects in the nursing infant are unknown.

See references

Further information

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

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