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)
Adverse reaction08.06.01.0180.005943%Not Available
Type 1 diabetes mellitus14.06.01.010; 10.04.08.007; 05.06.01.0100.001930%Not Available
Skin mass23.07.04.0140.000695%Not Available
Brain injury19.07.03.007; 17.11.01.003--Not Available
Oropharyngeal pain07.05.05.004; 22.12.03.0160.008053%
Genital hypoaesthesia21.10.05.012; 17.02.06.0280.000257%Not Available
Kounis syndrome24.04.04.020; 10.01.03.037; 02.02.02.0200.000772%Not Available
Upper-airway cough syndrome22.12.03.0360.001003%
Skin sensitisation10.02.01.038; 23.03.03.052--Not Available
Functional gastrointestinal disorder07.11.01.0160.000566%Not Available
Granulomatosis with polyangiitis24.12.04.011; 22.01.01.015; 20.05.01.013; 10.02.02.0180.001029%Not Available
Diffuse alopecia23.02.02.0070.001441%Not Available
Noninfective gingivitis07.09.13.016--Not Available
Intrusive thoughts19.10.03.0080.000257%Not Available
Persistent depressive disorder19.15.01.0060.000386%Not Available
Depersonalisation/derealisation disorder19.14.01.0040.000772%Not Available
Ureterolithiasis20.04.03.0030.000643%Not Available
Abnormal loss of weight14.03.02.0190.000772%Not Available
Acne conglobata23.02.01.0080.001003%Not Available
Adjustment disorder with depressed mood19.23.01.0020.000643%Not Available
Alcohol interaction08.06.03.003--Not Available
Alopecia scarring23.02.02.0090.000257%Not Available
Anorexia nervosa19.09.01.007; 14.03.03.0020.000257%Not Available
Arthritis reactive15.01.09.004; 10.02.01.070; 06.04.05.031; 11.07.01.013; 20.08.02.0140.000257%Not Available
Astigmatism06.02.04.0090.000566%Not Available
Coeliac disease14.02.01.007; 10.04.04.012; 07.17.01.0080.000901%Not Available
Colonic fistula07.11.05.0070.002187%
Eczema asteatotic23.03.04.0250.001595%Not Available
Enthesopathy15.07.01.0110.000643%Not Available
Ewing's sarcoma16.29.03.004; 15.09.03.0150.000257%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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