Adverse Drug Reaction Classification System

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)
Exercise tolerance decreased08.01.03.0360.000823%Not Available
Ligament calcification15.07.02.001--Not Available
Enterocutaneous fistula23.07.04.017; 07.11.05.0050.001544%Not Available
Large intestine polyp16.05.02.006; 07.20.01.0100.043354%Not Available
Conjunctival hyperaemia06.04.01.0040.000823%Not Available
Organic erectile dysfunction21.03.01.013; 19.08.04.0060.000386%Not Available
Metabolic syndrome24.08.02.014; 14.06.02.007; 05.06.02.0070.000695%Not Available
Gastrointestinal hypomotility07.02.02.0050.000386%Not Available
Eyelid margin crusting23.03.03.029; 06.04.04.0050.000875%Not Available
Drug tolerance decreased08.06.01.024--Not Available
Eosinophilic pneumonia acute22.01.01.008; 01.02.04.0040.000257%Not Available
Ingrown hair23.02.06.0080.000257%Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Protein urine present13.13.02.006--Not Available
Musculoskeletal discomfort15.03.04.0010.003010%Not Available
Secretion discharge08.01.03.0190.001569%Not Available
Type IV hypersensitivity reaction10.01.03.0220.000566%Not Available
Extraocular muscle disorder06.05.02.005; 15.05.05.0040.000386%Not Available
Growth retardation05.03.02.007; 14.03.02.031; 15.03.05.0160.001595%
Depressive symptom19.15.02.0030.010935%Not Available
Nodule08.03.05.002--Not Available
Affect lability19.04.01.0010.004297%Not Available
Skin burning sensation23.03.03.021; 17.02.06.009--Not Available
Haemorrhage24.07.01.002--Not Available
Colitis microscopic07.08.01.0110.002830%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.003--Not Available
Chronic hepatic failure09.01.03.0090.000257%Not Available
Testis cancer21.13.02.001; 16.25.03.001--Not Available
Anxiety disorder19.06.01.0020.000772%Not Available
Bipolar disorder19.16.01.0030.008233%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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