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)
Fibromyalgia15.05.02.0020.001029%Not Available
Musculoskeletal disorder15.03.05.025--Not Available
Intestinal polyp16.05.01.002; 07.20.01.0090.000515%Not Available
Dermatosis23.03.03.0170.000695%Not Available
Energy increased08.01.03.0170.000257%Not Available
Deafness unilateral04.02.01.0110.000386%Not Available
Underweight14.03.02.0170.000257%Not Available
Hypoacusis04.02.01.006--
Weight fluctuation14.03.02.002--Not Available
Autoimmune thyroiditis05.02.04.002; 10.04.08.0060.001029%Not Available
Chapped lips07.05.01.0040.045103%Not Available
Osteopenia15.02.03.003; 14.04.04.0040.007204%Not Available
Emotional distress19.04.02.0080.056399%Not Available
Acne fulminans23.02.01.0020.003654%Not Available
Red blood cell sedimentation rate increased13.01.03.001--Not Available
Lip haemorrhage24.07.02.028; 07.05.02.0020.006021%Not Available
Lip blister23.03.01.016; 07.05.01.0070.001647%Not Available
Bone density decreased13.16.01.001--Not Available
Anal haemorrhage24.07.02.029; 07.12.03.0040.000643%
Muscle fatigue15.05.03.0060.001003%Not Available
Urethral haemorrhage24.07.03.006; 20.07.01.0030.000386%Not Available
Blood glucose fluctuation13.02.02.007--Not Available
Lumbar radiculopathy17.10.03.0030.000257%Not Available
Anal inflammation07.03.03.0040.000515%
Dysstasia15.03.05.011; 08.01.03.089; 17.02.02.012--Not Available
Intervertebral disc protrusion15.10.01.0040.001081%Not Available
Morbid thoughts19.10.03.0040.000772%Not Available
Contusion24.07.06.001; 23.03.11.002; 12.01.06.001; 15.03.05.007--
Lower gastrointestinal haemorrhage24.07.02.030; 07.12.03.0110.001544%
Self-injurious ideation19.12.01.0070.007616%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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