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These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 1982
Medication labelWhy this: Advisory · dailymed-prescription
Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use: If a second course of isotretinoin capsules therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy [see Dosage and Administration (2.2)].
- generic_name
- isotretinoin
- product_names
- Isotretinoin
- ndc
- 69238-1254, 69238-1255, 69238-1256, 69238-1257, 69238-1258, 69238-1259, 69238-1254-4, 69238-1254-3, 69238-1255-4, 69238-1255-3, 69238-1256-4, 69238-1256-3, 69238-1257-4, 69238-1257-3, 69238-1258-4, 69238-1258-3, 69238-1259-4, 69238-1259-3
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en