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)
Hallucination, olfactory19.10.04.005--Not Available
Hemiplegic migraine17.14.02.004; 24.03.05.0120.000257%Not Available
Ileal stenosis07.13.06.0060.001672%
Impulsive behaviour19.18.01.0010.000386%Not Available
Intestinal fistula07.11.05.0120.000901%Not Available
Mitral valve prolapse02.07.01.0080.000257%Not Available
Morose19.04.02.0180.000386%Not Available
Neonatal respiratory distress syndrome22.11.02.010; 18.04.10.0030.000643%Not Available
Neuroblastoma17.20.03.002; 16.30.03.002; 05.01.04.0010.000257%Not Available
Normal newborn18.08.06.0010.002238%Not Available
Obstruction gastric07.13.04.0020.000257%
Ovarian cyst ruptured21.11.01.015; 16.04.03.0060.000386%Not Available
Pelvic adhesions21.07.04.009; 07.07.03.0050.000257%Not Available
Pityriasis rosea23.03.08.0030.000257%Not Available
Pneumothorax spontaneous22.05.02.0070.000257%Not Available
Post-traumatic stress disorder19.06.06.0020.002238%Not Available
Pouchitis12.02.03.022; 07.08.03.0170.005146%Not Available
School refusal19.07.05.002--Not Available
Selective IgA immunodeficiency10.03.01.0070.000257%Not Available
Social anxiety disorder19.06.03.0100.000257%Not Available
Violence-related symptom19.05.01.0220.000772%Not Available
Cerebral ventricle dilatation17.11.01.0130.000257%Not Available
Patellofemoral pain syndrome15.01.08.0130.000257%Not Available
Short-bowel syndrome12.02.03.024; 07.17.01.0100.000386%Not Available
Live birth18.08.02.0070.001595%Not Available
Hypothermia neonatal18.04.06.004; 12.05.03.002; 08.05.01.0070.000257%Not Available
Cervical radiculopathy17.10.02.0030.000515%Not Available
Anti-neutrophil cytoplasmic antibody positive vasculitis24.12.04.002; 10.02.02.0230.000515%Not Available
SAPHO syndrome23.03.10.005; 15.03.03.013; 10.02.01.0640.001029%Not Available
Bone marrow oedema15.02.01.005; 01.05.01.0190.001209%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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