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)
Ill-defined disorder08.01.03.049--Not Available
Intervertebral disc disorder15.10.01.0030.000257%Not Available
Lacrimal disorder06.08.02.0050.000566%Not Available
Polyp08.01.06.010; 16.02.02.0050.004245%Not Available
Sensation of foreign body08.01.09.002--Not Available
Vocal cord disorder22.04.01.0030.000566%Not Available
Adjustment disorder19.23.01.0010.000386%Not Available
Adverse drug reaction08.06.01.0090.170096%Not Available
Autoimmune disorder10.04.04.0030.000515%
Demyelinating polyneuropathy17.09.04.003; 10.04.10.0070.000386%Not Available
Diverticular perforation07.04.04.0080.000386%Not Available
Drug intolerance08.06.01.0130.044280%Not Available
Psychotic disorder19.03.01.002--
Hyperlipidaemia14.08.03.0010.005455%
Knee deformity15.10.03.0020.000772%Not Available
Large intestinal obstruction07.13.03.0030.000257%
Pigmentation disorder23.05.03.0010.001132%Not Available
Respiratory tract infection22.07.07.001; 11.01.08.017--Not Available
Unevaluable event08.01.03.0510.036767%Not Available
Urethritis noninfective20.07.02.0020.000386%Not Available
Chorioretinopathy06.09.01.0060.000515%Not Available
Excessive granulation tissue23.07.04.012; 08.03.02.0030.000386%Not Available
Pyramidal tract syndrome17.05.05.0030.000257%
Gastrointestinal inflammation07.08.03.0070.000257%Not Available
Skin haemorrhage24.07.01.103; 23.06.07.0010.001132%Not Available
Exfoliative rash23.03.07.0060.001132%Not Available
Ulcerative keratitis10.02.01.021; 06.04.02.0040.001081%
Meibomian gland dysfunction06.04.04.0150.001775%Not Available
Suicidal behaviour19.12.01.0060.001801%Not Available
Keratosis pilaris23.01.01.0020.000257%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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