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)
Abdominal adhesions07.07.03.001; 12.02.03.0060.000386%Not Available
Abdominal pain07.01.05.0020.069881%
Abortion18.01.01.0010.002187%Not Available
Abortion missed18.01.01.0020.000515%Not Available
Abortion spontaneous18.01.04.0010.025472%Not Available
Acne23.02.01.0010.065713%Not Available
Acne cystic23.02.01.0050.004631%Not Available
Acute febrile neutrophilic dermatosis23.03.03.033; 01.02.01.0060.000772%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute psychosis19.03.01.0010.000386%Not Available
Affective disorder19.04.04.0010.007436%Not Available
Ageusia17.02.07.001; 07.14.03.003--Not Available
Aggression19.05.01.0010.016235%Not Available
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Alcohol intolerance14.02.01.0010.000257%
Alopecia23.02.02.0010.056836%
Amenorrhoea05.05.01.002; 21.01.02.001--
Amnesia19.20.01.001; 17.03.02.001--
Anaemia01.03.02.001--
Anal fissure07.03.01.0020.025472%
Anal fistula07.11.05.0020.023156%
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anger19.04.02.0010.019914%Not Available
Angle closure glaucoma06.03.01.0010.000515%Not Available
Angular cheilitis07.05.07.013; 23.03.03.0540.000643%Not Available
Ankylosing spondylitis15.01.09.001; 10.04.04.0040.001801%Not Available
Anorgasmia19.08.01.0010.000386%
Anosmia22.04.03.006; 17.04.04.001--
Antisocial behaviour19.05.01.0100.000566%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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