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 For the treatment of severe recalcitrant nodular acne
Marketing Status Prescription; Discontinued
ATC Code D10AD04; D10BA01
DrugBank ID DB00982
KEGG ID D00348
MeSH ID D015474
PubChem ID 5282379
TTD Drug ID D00DKK
NDC Product Code 55111-113; 58243-010; 61748-301; 0555-1054; 10631-115; 68308-571; 76055-0010; 69238-1176; 71052-426; 69238-1174; 61748-304; 10631-005; 0245-0575; 68308-575; 72143-231; 69238-1017; 0555-1055; 64566-0014; 57664-021; 57664-024; 0555-1056; 55111-137; 0378-6612; 10631-117; 0245-0570; 64566-0004; 72143-232; 57664-022; 10631-118; 55111-135; 43744-242; 64566-0003; 0591-2435; 69238-1175; 0591-2501; 10631-116; 61748-303; 67262-0003; 72969-036; 0555-1057; 72143-234; 0245-0573; 57664-020; 0591-2433; 57664-023; 68308-573; 61748-302; 72143-233; 48943-0010; 0378-6614; 0591-2434; 0245-0571; 10631-134; 0591-2436; 68308-570; 0378-6611; 65977-0135; 17337-0024; 57664-025; 10631-002; 0591-2451; 10631-007; 10631-003; 10631-133; 55111-136
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Lipids abnormalLow density lipoproteinE1B4S5Not Available2931603; 6228196; 9427082; 2961629; 1944471; 10938014; 7820162; 2011077; 190608; 2958204; 9058708; 3469279; 2743372; 2938993; 10383074; 7606632; 12966367; 9253322; 9253322; 16429299; 9647874
Lipids abnormalVigilinQ00341Not Available2931603; 6228196; 9427082; 2961629; 1944471; 10938014; 7820162; 2011077; 190608; 2958204; 9058708; 3469279; 2743372; 2938993; 10383074; 7606632; 12966367; 9253322; 9253322; 16429299; 9647874
Low density lipoprotein increasedApolipoprotein B-100P04114T075332961629; 2931603; 2958204; 11955026; 7076797; 3973021; 7059324; 6403642; 6228196; 6799600; 9058708; 7288286; 7138621; 11443178; 3973025; 16429299
Low density lipoprotein increasedAquaporin PIP1-2Q06611Not Available2961629; 2931603; 2958204; 11955026; 7076797; 3973021; 7059324; 6403642; 6228196; 6799600; 9058708; 7288286; 7138621; 11443178; 3973025; 16429299
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.0020.095346%
Abdominal pain upper07.01.05.003--
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Abnormal weight gain14.03.02.0100.001263%Not Available
Abortion18.01.01.0010.005051%Not Available
Abortion missed18.01.01.0020.001263%Not Available
Abortion spontaneous18.01.04.0010.078297%Not Available
Abscess11.01.08.0010.001894%Not Available
Acne23.02.01.0010.059986%Not Available
Acne cystic23.02.01.0050.001894%Not Available
Acne pustular23.02.01.007; 11.01.12.0160.001894%Not Available
Acute febrile neutrophilic dermatosis23.03.03.033; 01.02.01.0060.001263%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute psychosis19.03.01.0010.001894%Not Available
Affective disorder19.04.04.0010.014523%Not Available
Ageusia17.02.07.001; 07.14.03.003--Not Available
Aggression19.05.01.0010.041043%Not Available
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase increased13.03.01.0030.044831%
Alcohol intolerance14.02.01.0010.001263%
Alopecia23.02.02.0010.042937%
Amenorrhoea21.01.02.001; 05.05.01.002--
Amnesia19.20.01.001; 17.03.02.001--
Anaemia01.03.02.001--
Anal atresia03.04.06.001; 07.13.05.0010.001894%Not Available
Anal fissure07.03.01.0020.009471%
Anal fistula07.11.05.0020.002526%
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