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)
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.0010.098080%
Myasthenia gravis17.05.04.001; 15.05.08.001; 10.04.05.0010.000386%
Myocarditis02.04.03.001--
Myopathy15.05.05.0010.000643%Not Available
Myopia06.02.04.0020.001724%Not Available
Myositis15.05.01.0010.000643%
Nail dystrophy23.02.05.003--Not Available
Nasal dryness22.04.03.0020.018345%Not Available
Nasal polyps22.04.03.010; 16.38.01.0010.000257%Not Available
Nasal septum deviation22.04.03.0190.000386%Not Available
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Neck pain15.03.04.0090.007667%
Nephritis20.05.02.0010.000257%Not Available
Nephrolithiasis20.04.01.0020.008336%
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.003--Not Available
Neurodermatitis23.03.04.0070.000875%Not Available
Neutropenia01.02.03.004--Not Available
Night blindness06.02.10.010; 14.12.03.0010.006381%
Nightmare19.02.03.003--Not Available
Normochromic normocytic anaemia01.03.02.0050.000386%Not Available
Obsessive-compulsive disorder19.06.05.0020.002624%Not Available
Obsessive-compulsive personality disorder19.05.04.0010.000257%Not Available
Ocular hyperaemia06.04.05.004--Not Available
Odynophagia07.01.06.0360.001389%Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Oesophageal stenosis07.13.02.0010.000257%
Oesophageal ulcer07.04.05.0020.000643%
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ADReCS-Target
Drug Name ADR Term Target
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