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)
Multiparous26.05.01.003--Not Available
Muscle spasms15.05.03.0040.001650%
Muscular weakness15.05.06.001; 17.05.03.005--
Myalgia15.05.02.001--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.0010.004125%
Nervous system disorder17.02.10.001--Not Available
Oedema14.05.06.010; 08.01.07.0060.001237%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.001237%
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Pelvic inflammatory disease21.14.04.001; 11.01.10.006--Not Available
Pituitary-dependent Cushing's syndrome05.03.01.004--Not Available
Pneumonia11.01.09.003; 22.07.01.0030.000825%Not Available
Presyncope24.06.02.010; 17.02.05.009; 02.01.02.0070.000825%
Pruritus23.03.12.001--
Pyrexia08.05.02.0030.000825%
Rash23.03.13.001--Not Available
Rash generalised23.03.13.0020.000825%Not Available
Rash maculo-papular23.03.13.004--
Sinusitis22.07.03.007; 11.01.13.005--
Skin disorder23.03.03.007--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Syncope17.02.04.008; 02.01.02.008; 24.06.02.0120.000825%
Tachycardia02.03.02.0070.000825%Not Available
Thirst14.03.02.007; 08.01.09.021--Not Available
Thyroid function test abnormal13.10.06.001--Not Available
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 10.01.01.006; 11.07.01.006--
Toxic shock syndrome24.06.02.015; 11.01.08.028--Not Available
Urticaria23.04.02.001; 10.01.06.001--
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