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)
Behaviour disorder19.01.01.0050.001081%Not Available
Bell's palsy17.04.03.0110.000257%Not Available
Binge drinking19.07.06.0070.000257%Not Available
Bone hypertrophy15.02.04.0410.000515%Not Available
Childhood depression19.15.01.0090.000257%Not Available
Choroid melanoma06.12.04.001; 16.34.04.0010.000515%Not Available
Chronic cutaneous lupus erythematosus15.06.02.013; 10.04.03.013; 23.03.02.022--Not Available
Colorectal adenoma07.20.01.019; 16.05.02.0090.000386%Not Available
Cytotoxic lesions of corpus callosum17.02.10.030; 12.03.01.0620.000257%Not Available
Diffuse idiopathic skeletal hyperostosis15.01.09.0060.000643%Not Available
Drug effect less than expected08.06.01.0360.000875%Not Available
Enterocolonic fistula07.11.05.0190.001029%Not Available
Epiphyseal disorder15.02.02.0030.000386%Not Available
Facial discomfort08.01.08.0310.000257%Not Available
Graves' disease05.02.02.009; 10.04.08.014; 06.09.04.0090.000257%Not Available
Growth failure15.03.05.015; 14.03.02.030; 05.03.02.0060.001029%Not Available
Heavy menstrual bleeding21.01.03.005--Not Available
Hypertrophic anal papilla07.03.01.0090.000386%Not Available
Idiopathic intracranial hypertension17.07.02.0110.004606%Not Available
Joint noise15.01.02.0120.000257%Not Available
Lacrimal gland enlargement06.06.04.0270.000566%Not Available
Lip erythema07.05.05.0280.000566%Not Available
Mucosal disorder08.01.06.029--Not Available
Neonatal neuroblastoma17.20.03.004; 16.30.03.004; 05.01.04.0110.000257%Not Available
Neuroblastoma recurrent17.20.03.005; 16.30.03.005; 05.01.04.0120.000257%Not Available
Paediatric acute-onset neuropsychiatric syndrome11.07.01.028; 10.04.10.021; 19.06.05.013; 17.02.05.0740.000257%Not Available
Pregnancy on contraceptive18.08.01.0040.000901%Not Available
Pregnancy on oral contraceptive18.08.01.0050.001286%Not Available
Psychotic symptom19.03.01.012--Not Available
Purging19.09.02.0020.000566%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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