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)
Rheumatoid arthritis15.01.03.001; 10.04.06.0010.002959%Not Available
Rhinitis allergic22.04.04.003; 10.01.04.0030.001029%
Rickets15.02.03.006; 14.04.04.0050.000257%Not Available
Rosacea23.02.08.0010.000875%Not Available
Sacroiliitis15.01.01.012; 10.02.01.1040.013637%Not Available
Sarcoidosis10.02.06.0010.000257%Not Available
Scab23.03.03.0040.001389%Not Available
Seborrhoea23.02.07.0010.000695%Not Available
Seborrhoeic dermatitis23.03.04.0180.001081%Not Available
Seizure17.12.03.001--
Sensory disturbance17.02.07.006--Not Available
Sepsis11.01.11.003--
Shock24.06.02.002--Not Available
Sinus headache22.12.03.022; 17.14.01.0020.000566%
Skin atrophy23.01.05.001--
Skin discolouration23.03.03.005--Not Available
Skin disorder23.03.03.007--Not Available
Skin erosion23.07.03.0020.000875%Not Available
Skin exfoliation23.03.07.0030.009082%Not Available
Skin fissures23.03.03.0080.002084%Not Available
Skin fragility23.03.03.0090.000515%Not Available
Skin hyperpigmentation23.05.01.003--
Skin hypopigmentation23.05.02.0030.000695%
Skin infection23.11.04.007; 11.01.12.003--
Skin irritation23.03.04.0090.006201%Not Available
Skin odour abnormal23.03.03.0120.000875%
Skin papilloma16.26.01.002; 11.05.07.001; 23.10.01.0020.001801%
Skin striae23.01.05.002--Not Available
Skin ulcer24.04.03.007; 23.07.03.003--
Skin wrinkling23.01.03.0010.001750%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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