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)
Male sexual dysfunction19.08.05.003; 21.03.02.0120.000386%Not Available
Major depression19.15.01.0030.004889%Not Available
Tendon calcification15.07.01.006--Not Available
Asteatosis23.02.07.0060.000257%Not Available
Dysplasia08.03.04.0070.000257%Not Available
Myoglobinaemia15.05.03.028; 02.04.02.0280.000257%Not Available
Intestinal haemorrhage24.07.02.031; 07.12.03.0050.034863%Not Available
Blood alkaline phosphatase increased13.04.02.004--
Abdominal symptom07.01.06.0070.000875%Not Available
Adverse event08.06.01.0100.051484%Not Available
Appetite disorder19.09.01.002; 14.03.01.0040.001132%Not Available
Cardiac disorder02.11.01.003--Not Available
Colon neoplasm16.13.02.001; 07.21.10.0010.000257%Not Available
Gastrointestinal neoplasm16.13.11.001; 07.21.04.0020.000257%Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Inflammation10.02.01.089; 08.01.05.007--Not Available
Intervertebral disc degeneration15.10.01.0020.001415%Not Available
Jaw disorder15.02.04.0090.000257%Not Available
Mental disorder19.07.01.0020.019966%Not Available
Oesophageal disorder07.11.02.0010.000515%Not Available
Optic nerve disorder17.04.05.004; 06.02.08.001--
Spondylitis15.01.09.0020.000386%Not Available
Abnormal behaviour19.01.01.0010.008954%Not Available
Decreased appetite08.01.09.028; 14.03.01.005--
Corneal disorder06.08.01.0040.000515%Not Available
External ear disorder04.01.01.0030.000257%Not Available
Gastrointestinal ulcer07.04.04.0020.000772%Not Available
Erectile dysfunction21.03.01.007; 19.08.04.0010.012685%
Psychiatric symptom19.01.02.0010.004065%Not Available
Reproductive tract disorder21.10.05.0060.000566%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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