Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Mifepristone
Drug ID BADD_D01463
Description Mifepristone is a progestational and glucocorticoid hormone antagonist. Its inhibition of progesterone induces bleeding during the luteal phase and in early pregnancy by releasing endogenous prostaglandins from the endometrium or decidua. As a glucocorticoid receptor antagonist, the drug has been used to treat hypercortisolism in patients with nonpituitary cushing syndrome. The two marketed forms of mifepristone are Mifeprex® (mifepristone 200mg) and Korlym™ (mifepristone 300mg). Currently under investigation for use in psychotic depression (phase 3 trials).
Indications and Usage For the medical termination of intrauterine pregnancy through 49 days' pregnancy. Also indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and are not candidates for surgery or have had unsuccessful surgery.
Marketing Status Prescription
ATC Code G03XB01
DrugBank ID DB00834
KEGG ID D00585
MeSH ID D015735
PubChem ID 55245
TTD Drug ID D0Z4EI
NDC Product Code 51508-011; 68925-0004; 43393-001; 69989-0003; 44132-005; 65089-0043; 66499-0056; 76346-073; 60722-3002; 44132-013
Synonyms Mifepristone | ZK-98296 | ZK 98296 | ZK98296 | R-38486 | R 38486 | RU-486 | RU 486 | RU486 | R38486 | RU-38486 | RU 38486 | RU38486 | Mifegyne | Mifégyne | Mifeprex
Chemical Information
Molecular Formula C29H35NO2
CAS Registry Number 84371-65-3
SMILES CC#CC1(CCC2C1(CC(C3=C4CCC(=O)C=C4CCC23)C5=CC=C(C=C5)N(C)C)C)O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
HyperphagiaPro-neuropeptide YP01303T516711653393; 2373052; 2019270; 1363327; 1597158; 1407382; 10799663; 10792576; 1564428; 2967189; 10369453; 1657667; 8049712; 9176325; 8603777; 12746327; 11737554; 8505677; 15256810; 7737322
Intestinal congestionPro-neuropeptide YP01303T516711653393; 2373052; 2019270; 1363327; 1597158; 1407382; 10799663; 10792576; 1564428; 2967189; 10369453; 1657667; 8049712; 9176325; 8603777; 12746327; 11737554; 8505677; 15256810; 7737322
ObesityPro-neuropeptide YP01303T516711653393; 2373052; 2019270; 1363327; 1597158; 1407382; 10799663; 10792576; 1564428; 2967189; 10369453; 1657667; 8049712; 9176325; 8603777; 12746327; 11737554; 8505677; 15256810; 7737322
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Uterine rupture21.07.01.009; 18.02.02.001; 12.01.15.001--Not Available
Vaginal discharge21.08.02.0020.000825%
Vaginal haemorrhage24.07.03.005; 21.08.01.0010.005774%
Vomiting07.01.07.0030.002062%
Weight decreased13.15.01.0050.000825%
Acute generalised exanthematous pustulosis23.03.10.002; 12.03.01.0050.001650%Not Available
Uterine contractions during pregnancy18.08.02.005--Not Available
Musculoskeletal chest pain22.09.01.001; 15.03.04.012--
Haemorrhagic anaemia24.07.01.038; 01.03.02.0130.000825%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Thyroxine free decreased13.10.06.0090.001237%Not Available
Haemorrhage24.07.01.0020.004949%Not Available
Endometrial thickening21.07.01.013--Not Available
Angiopathy24.03.02.007--Not Available
Hot flush08.01.03.027; 24.03.01.005; 21.02.02.001--
Breast disorder21.05.04.004--Not Available
Connective tissue disorder15.06.01.006--Not Available
Infestation23.09.05.001; 11.09.01.001--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Decreased appetite08.01.09.028; 14.03.01.005--
Ill-defined disorder08.01.03.049--Not Available
Acute kidney injury20.01.03.0160.000825%
Adrenal gland cancer16.24.06.001; 05.01.04.005--Not Available
Maternal drugs affecting foetus18.03.03.009; 12.03.03.0060.000825%Not Available
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