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)
Sleep disorder	19.02.04.001	-	-	Not Available
Small intestinal obstruction	07.13.06.001	0.020841%
Small intestinal perforation	07.04.06.006	0.000515%
Social avoidant behaviour	19.05.01.007	0.003679%		Not Available
Somnolence	19.02.05.003; 17.02.04.006	-	-
Speech disorder	22.12.03.027; 19.19.02.002; 17.02.08.003	-	-	Not Available
Stevens-Johnson syndrome	12.03.01.014; 11.07.01.005; 10.01.01.045; 23.03.01.007	-	-
Stomatitis	07.05.06.005	-	-
Strabismus	17.17.01.009; 06.05.02.004	0.001132%		Not Available
Stress	19.06.02.004	0.035146%		Not Available
Suicidal ideation	19.12.01.003	0.107085%
Suicide attempt	19.12.01.004	0.023928%
Sunburn	23.03.09.007; 12.05.02.001	-	-	Not Available
Superior sagittal sinus thrombosis	24.01.04.004; 17.08.03.001	0.000257%		Not Available
Swelling face	08.01.03.100; 23.04.01.018; 10.01.05.018	-	-	Not Available
Syncope	02.11.04.015; 24.06.02.012; 17.02.04.008	-	-
Systemic lupus erythematosus	23.03.02.006; 15.06.02.003; 10.04.03.004	-	-	Not Available
Systemic lupus erythematosus rash	23.03.13.007; 15.06.02.005; 10.04.03.005	0.000257%		Not Available
Tachycardia	02.03.02.007	-	-	Not Available
Tearfulness	19.15.02.005	0.005943%		Not Available
Temporomandibular joint syndrome	17.14.01.017; 15.01.08.008	0.000566%		Not Available
Tendonitis	12.01.07.007; 15.07.01.003	0.002547%		Not Available
Tension	19.06.02.005	-	-	Not Available
Tension headache	19.24.01.009; 17.14.01.004	0.001827%		Not Available
Thinking abnormal	19.10.03.001; 17.02.05.023	0.001853%		Not Available
Thirst	14.03.02.007; 08.01.09.021	-	-	Not Available
Thrombocytopenia	01.08.01.002	-	-	Not Available
Thrombocytosis	01.08.02.001	0.000823%		Not Available
Thrombosis	24.01.01.006	-	-	Not Available
Thyroid disorder	05.02.01.002	0.001518%		Not Available

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