Isotretinoin
Systemic Retinoid (Acne Therapy)
Isotretinoin is one of the most potent human teratogens known. Causes major congenital malformations in 25–30% of exposed fetuses (craniofacial, cardiac conotruncal, thymic, and central nervous system defects).
FDA Black Box Warning & iPLEDGE Program: Isotretinoin is strictly contraindicated. 2 forms of effective contraception are required for 1 month before, during, and 1 month after treatment.
Severe retinoid embryopathy. 25-30% rate of major structural birth defects.
Severe CNS damage, hydrocephalus, microcephaly.
Severe neurological impairment and fetal demise.
Disrupts neural crest cell migration and homeobox gene expression during embryogenesis.
Microtia/anotia (missing/small ears), cleft palate, facial dysmorphism, transposition of great vessels.
Spontaneous abortion rate exceeds 40%.
Must not be taken during pregnancy under any circumstances.
Discontinue isotretinoin immediately and consult your OB/GYN.
- Comprehensive genetic and teratology consultation
- High-resolution level II anatomical ultrasound
- FDA iPLEDGE Program mandating negative pregnancy tests prior to dispensing.
Isotretinoin (Accutane) causes severe birth defects in almost 1 out of 3 exposed babies. You must never take it while pregnant.
You must wait at least 1 full month after your last dose of isotretinoin before trying to conceive.
Well-established human teratogenic syndrome and Black Box Warning.
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1
U.S. Food and Drug Administration (FDA) PLLR — FDA Pregnancy and Lactation Labeling Rule & Approved Prescribing Information Database Last updated: Official FDA Standard
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2
FDA Center for Drug Evaluation and Research (CDER) — FDA MedWatch & Black Box Warning Database Last updated: Official FDA Standard
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3
ACOG Practice Bulletins & Guidelines — American College of Obstetricians and Gynecologists Clinical Recommendations Last updated: 2025 Clinical Edition
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4
Briggs Drugs in Pregnancy and Lactation — Reference Guide to Fetal and Neonatal Risk (12th Edition) Last updated: 2025 Clinical Edition