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)
Body dysmorphic disorder	19.06.05.008	0.000566%		Not Available
Perineal fistula	21.10.05.018	0.000386%		Not Available
Pseudopolyp	08.01.05.015	0.001029%		Not Available
Gastrointestinal oedema	07.11.01.012	0.004889%		Not Available
Negative thoughts	19.15.02.012	0.001518%		Not Available
Disturbance in social behaviour	19.05.01.018	0.000386%		Not Available
Female genital tract fistula	12.02.14.010; 23.07.04.015; 21.10.05.009; 20.08.01.007; 07.11.05.004	0.001672%		Not Available
Small intestinal stenosis	07.13.06.008	0.000257%
Enterovesical fistula	20.03.01.021; 07.11.05.009	0.000643%
Eosinophilic oesophagitis	10.01.01.030; 07.08.05.006; 01.02.04.016	0.000386%		Not Available
Lip exfoliation	07.05.05.020	0.003525%		Not Available
Tachyphrenia	19.10.03.010; 17.03.03.007	0.000386%		Not Available
Rectal fissure	07.03.01.007	0.003602%
Medial tibial stress syndrome	15.02.04.036	0.000566%		Not Available
Fistula of small intestine	12.02.03.026; 07.11.05.010	0.000901%
Pulmonary renal syndrome	22.01.01.022; 20.05.01.019; 10.04.04.017	0.000643%		Not Available
Facial asymmetry	15.10.05.004	0.000257%		Not Available
Spinal pain	17.10.01.020; 15.02.01.008; 08.01.08.030	-	-	Not Available
Chronic pigmented purpura	24.07.06.021; 23.06.01.013; 01.01.04.010	0.000257%		Not Available
Large intestinal stenosis	07.13.03.004	0.001029%
Nonreassuring foetal heart rate pattern	18.03.02.017; 02.03.02.027	0.000257%		Not Available
Toxic goitre	14.11.01.046; 05.02.02.006	0.000386%		Not Available
Disorganised speech	19.19.02.005; 17.02.08.017	0.000257%		Not Available
Unmasking of previously unidentified disease	08.01.03.080	0.000386%		Not Available
Autoimmune hypothyroidism	10.04.08.009; 05.02.03.005	0.000257%		Not Available
Anal polyp	16.05.02.008; 07.20.01.016	0.001158%		Not Available
Anal stenosis	07.13.05.004	0.001930%
Anembryonic gestation	18.01.03.007	0.000257%		Not Available
Arthritis enteropathic	07.08.03.019; 15.01.01.017; 10.02.01.069	0.000643%		Not Available
Attention deficit hyperactivity disorder	19.21.04.004	0.002959%		Not Available

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