US: Absorica, Amnesteem, Claravis, Myorisan, Zenatane
CAN: Accutane, Clarus, Epuris
Accotin (DK), Acnal SC (KR), Acnecur (PY), Acnemin (ES), Acnetrex (PH), Acnotin (CL, EC, HK, PE, SG, TH), Acnova (BR), Acugen (PH), Akinol (KR), Aknenormin (DE), Atlacne (AR), Atretin (CO), Claravis (BM), Contracne (FR), Cosmin (PK), Curacne (AE, JO, KW, LB), Curacne Ge (FR), Curakne (CH), Curatane (IL), Dermatane (AU), Hyndriax (CR, DO, GT, HN, NI, PA, SV), Isocutan (AR), Isoface (CO, CR, DO, EC, GT, HN, MX, NI, PA, PE, PY, SV, VE), Isosupra (BE), Isotane (TH), Isotina (KR), Isotinon (KR), Isotren (KR), Isotret-Hexal (DE), Isotrex (AE, AU, BH, BR, CL, CY, DK, GB, HU, ID, IE, LU, MX, PK, QA, SA, SG, TW), Isotrex Gel (DE, FR, HK, IL, IT, MY, PH, PL, TH), Isotroin (IN, LB), Neotrex (MX), Nimegen (MY, SG), Oratane (AE, AU, MY, NZ, SG), Procuta Ge (FR), Reducar (HK), Roaccutan (AR, CO, EC, FI, HU, IT, MX, PE, PT, PY, UY, VE), Roaccutane (AE, AU, BB, BE, BG, BH, BS, BZ, CH, CY, CZ, EE, EG, FR, GB, GH, GR, GY, HK, HR, IE, IL, IQ, IR, JM, JO, KE, KR, KW, LB, LT, LU, LY, NL, OM, PH, PK, PR, QA, SA, SI, SK, SR, SY, TH, TR, TT, TW, TZ, UG, YE, ZM), Roacnetan (CN), Roacta (TH), Roacutan (BR), Rocta (AU), Sotret (IN, TH), Sotrexe (MX), Tretin (KR)
Black box warning
See product data sheet for complete boxed warning.
CONTRAINDICATIONS AND WARNINGS: Isoniazid must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe 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 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.