Last reviewed 2026-04-20 · How we verify

Accutane (ISOTRETINOIN)

Accutane (Isotretinoin) is a small molecule retinoid that targets the retinoic acid receptor alpha. It was originally developed and is currently owned by Sun Pharm Inds Inc. Accutane is FDA-approved for treating severe recalcitrant nodular acne and hypertensive disorder, with a half-life of 90 hours and bioavailability of 40%. The drug is off-patent, with 9 generic manufacturers available. Key safety considerations include its teratogenic effects, requiring strict pregnancy prevention measures.

At a glance

Approved indications

• Severe Recalcitrant Nodular Acne

Boxed warnings

• CONTRAINDICATIONS AND WARNINGS Isotretinoin capsules must not be used by patients who are or may become pregnant. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking isotretinoin capsules in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Birth defects which have been documented following isotretinoin capsules exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported. Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted. If pregnancy does occur during treatment of a patient who is taking isotretinoin capsules, isotretinoin capsules must be discontinued immediately and the patient should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling. Special Prescribing Requirements Because of isotretinoin teratogenicity and to minimize fetal exposure, isotretinoin capsules approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This REMS is called iPLEDGE ® . Isotretinoin capsules must only be prescribed by prescribers who are enrolled and activated with the iPLEDGE REMS. Isotretinoin capsule s must only be dispensed by a pharmacy enrolled and activated with iPLEDGE, and must only be dispensed to patients who are enrolled and meet all the requirements of iPLEDGE (see PRECAUTIONS ).

Common side effects

• Unintended pregnancy
• Abortion induced
• Depression
• Exposure during pregnancy
• Mood altered
• Suicidal ideation
• Blood triglycerides increased
• Dry skin
• Lip dry
• Treatment noncompliance
• No adverse event
• Mood swings

Drug interactions

• Vitamin A
• Tetracyclines
• Micro-dosed Progesterone Preparations
• Norethindrone/ethinyl estradiol
• St. John's Wort
• Phenytoin

Key clinical trials

• Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma (PHASE1)
• Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
• Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906) (PHASE1,PHASE2)
• Isotretinoin vs hCG for Male Infertility Due to Low or Absent Sperm (PHASE2)
• Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (PHASE3)
• Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (PHASE3)
• Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation (EARLY_PHASE1)
• Pediatric Precision Laboratory Advanced Neuroblastoma Therapy (PHASE2)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Accutane CI brief — competitive landscape report
• Accutane updates RSS · CI watch RSS