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)
Sleep disorder19.02.04.001--Not Available
Small intestinal obstruction07.13.06.0010.020841%
Small intestinal perforation07.04.06.0060.000515%
Social avoidant behaviour19.05.01.0070.003679%Not Available
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.003--Not Available
Stevens-Johnson syndrome11.07.01.005; 10.01.01.045; 23.03.01.007; 12.03.01.014--
Stomatitis07.05.06.005--
Strabismus17.17.01.009; 06.05.02.0040.001132%Not Available
Stress19.06.02.0040.035146%Not Available
Suicidal ideation19.12.01.0030.107085%
Suicide attempt19.12.01.0040.023928%
Sunburn23.03.09.007; 12.05.02.001--Not Available
Superior sagittal sinus thrombosis24.01.04.004; 17.08.03.0010.000257%Not Available
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.018--Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Systemic lupus erythematosus23.03.02.006; 15.06.02.003; 10.04.03.004--Not Available
Systemic lupus erythematosus rash15.06.02.005; 10.04.03.005; 23.03.13.0070.000257%Not Available
Tachycardia02.03.02.007--Not Available
Tearfulness19.15.02.0050.005943%Not Available
Temporomandibular joint syndrome17.14.01.017; 15.01.08.0080.000566%Not Available
Tendonitis15.07.01.003; 12.01.07.0070.002547%Not Available
Tension19.06.02.005--Not Available
Tension headache19.24.01.009; 17.14.01.0040.001827%Not Available
Thinking abnormal19.10.03.001; 17.02.05.0230.001853%Not Available
Thirst14.03.02.007; 08.01.09.021--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombocytosis01.08.02.0010.000823%Not Available
Thrombosis24.01.01.006--Not Available
Thyroid disorder05.02.01.0020.001518%Not Available
The 15th Page    First    Pre   15 16 17 18 19    Next   Last    Total 25 Pages
ADReCS-Target
Drug Name ADR Term Target
Tip:  Drug Name  ADR Term  Protein  Variation  Gene