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)
Ileus paralytic07.02.05.0010.000643%Not Available
Impaired healing08.03.02.0010.004271%Not Available
Inappropriate affect19.04.01.0050.000515%Not Available
Infection11.01.08.002--Not Available
Infertility21.03.02.0010.001389%Not Available
Inflammatory bowel disease07.08.01.0160.343100%Not Available
Ingrowing nail23.02.05.0110.004014%Not Available
Inguinal hernia07.16.02.0010.000643%Not Available
Insomnia19.02.01.002; 17.15.03.002--
Intentional self-injury19.12.01.002; 12.01.08.0360.006690%Not Available
Intestinal obstruction07.13.01.0020.061364%Not Available
Intestinal perforation07.04.06.0020.002316%Not Available
Intestinal stenosis07.13.01.0030.001158%Not Available
Intracranial pressure increased17.07.02.0020.000901%Not Available
Intussusception07.13.01.0080.000386%Not Available
Iritis10.02.01.022; 06.04.03.0020.000772%Not Available
Iron deficiency14.13.02.0020.000695%Not Available
Iron deficiency anaemia14.13.02.001; 01.03.01.0020.005969%Not Available
Irritability19.04.02.013; 08.01.03.0110.018242%
Irritable bowel syndrome19.24.01.003; 07.02.04.0030.151880%Not Available
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.004--Not Available
Joint ankylosis15.01.08.006--Not Available
Joint stiffness15.01.02.0030.004528%Not Available
Keloid scar23.01.03.0020.001569%Not Available
Keratitis06.04.02.0020.000952%
Keratoconus06.06.03.0170.001467%Not Available
Ketonuria20.02.01.0090.000257%Not Available
Lacrimation decreased06.08.02.007--Not Available
Lacrimation increased06.08.02.004--
Large intestinal ulcer07.04.06.0040.001415%
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ADReCS-Target
Drug Name ADR Term Target
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