ADReCS

Pharmaceutical Information

Drug Name	Isotretinoin
Drug ID	BADD_D01213
Description	Isotretinoin is a retinoid derivative of vitamin A used in the treatment of severe recalcitrant acne.[Label] It was most widely marketed under the brand name Accutane, which has since been discontinued.[L6574] Isotretinoin is associated with major risks in pregnancy and is therefore only available under the iPLEDGE program in the United States.[L6579] The first isotretinoin-containing product was FDA approved on 7 May 1982.[L6574]
Indications and Usage	Isotretinoin is indicated to treat severe recalcitrant nodular acne and patients ≥12 years enrolled in the iPLEDGE program.[Label,L6579]
Marketing Status	approved
ATC Code	D10AD04; D10BA01
DrugBank ID	DB00982
KEGG ID	D00348
MeSH ID	D015474
PubChem ID	5282379
TTD Drug ID	D00DKK
NDC Product Code	10631-133; 65655-0006; 0245-0573; 61748-303; 61748-304; 72143-252; 0832-8304; 65655-0003; 65977-0135; 55111-136; 61748-302; 69238-1176; 0591-2435; 72143-232; 10631-116; 10631-118; 57664-023; 68308-573; 0555-1056; 72143-253; 57664-020; 10631-003; 10631-005; 64566-0003; 0378-6614; 68308-570; 69238-1175; 0591-2434; 0591-2501; 72143-233; 0832-8302; 10631-007; 10631-117; 57664-025; 0378-6611; 68308-571; 69238-1017; 72143-251; 72143-254; 64566-0004; 65655-0005; 0245-0570; 61748-301; 68308-575; 0555-1057; 0591-2433; 0591-2436; 10631-002; 10631-115; 10631-134; 64566-0014; 65655-0004; 76055-0010; 0245-0575; 0378-6612; 0555-1055; 72143-231; 0832-8303; 17337-0024; 55111-113; 69238-1174; 0591-2451; 72143-234; 0832-8301; 55111-137; 57664-022; 0555-1054; 67262-0003; 71052-426; 0245-0571; 55111-135; 57664-021; 57664-024
UNII	EH28UP18IF
Synonyms	Isotretinoin \| 13-cis-Retinoic Acid \| 13 cis Retinoic Acid \| Isotretinoin Zinc Salt, 13-cis-Isomer \| Isotretinoin Zinc Salt, 13 cis Isomer \| Roaccutane \| Accutane \| Ro 4-3780 \| Ro 4 3780 \| Ro 43780

Chemical Information

Molecular Formula	C20H28O2
CAS Registry Number	4759-48-2
SMILES	CC1=C(C(CCC1)(C)C)C=CC(=CC=CC(=CC(=O)O)C)C
Chemical Structure

ADRs Induced by Drug

*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..

ADR Term	ADReCS ID	ADR Frequency (FAERS)	ADR Severity Grade (FAERS)	ADR Severity Grade (CTCAE)
Bone development abnormal	15.02.04.003	-	-	Not Available
Bone disorder	15.02.04.004	0.001595%		Not Available
Bone pain	15.02.01.001	-	-
Breast cancer	21.05.01.003; 16.10.01.001	-	-	Not Available
Bronchospasm	22.03.01.004; 10.01.03.012	-	-
Bulimia nervosa	19.09.01.006; 14.03.03.001	0.000566%		Not Available
Burning sensation	17.02.06.001; 08.01.09.029	-	-	Not Available
Bursitis	15.04.01.001; 12.04.03.010	0.001132%		Not Available
Capillary leak syndrome	24.06.03.001; 08.01.07.012	0.000257%
Cardiovascular disorder	02.11.01.010; 24.03.02.009	-	-	Not Available
Cataract	06.06.01.001	-	-
Cerebrovascular accident	17.08.01.007; 24.03.05.001	-	-
Cerebrovascular disorder	24.03.05.002; 17.08.02.002	-	-	Not Available
Cervical dysplasia	21.06.01.002	0.000386%		Not Available
Cheilitis	23.03.03.025; 07.05.01.001	0.039006%
Cheilosis	23.03.03.026; 07.05.01.002	0.000386%		Not Available
Chest pain	22.12.02.003; 08.01.08.002; 02.02.02.011	-	-	Not Available
Chloasma	23.05.01.001; 18.08.02.002	0.000566%		Not Available
Cholangitis sclerosing	10.04.09.002; 09.02.01.003	0.005918%		Not Available
Cholecystitis chronic	09.03.01.004	0.000901%		Not Available
Chromaturia	20.02.01.002	-	-
Chronic fatigue syndrome	11.07.01.020; 08.01.01.013	0.001158%		Not Available
Cold sweat	23.02.03.002; 08.01.03.024	-	-	Not Available
Colitis	07.08.01.001	0.028817%
Colitis ischaemic	24.04.08.012; 07.08.01.004	0.001544%		Not Available
Colitis ulcerative	10.02.01.004; 07.08.01.005	0.291436%		Not Available
Colon cancer	16.13.01.001; 07.21.01.001	0.002573%		Not Available
Colour blindness	06.02.09.001; 03.01.01.001	-	-	Not Available
Coma	17.02.09.001	-	-	Not Available
Completed suicide	19.12.01.001; 08.04.01.010	-	-	Not Available

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