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 approved; investigational
ATC Code G03XB01
DrugBank ID DB00834
KEGG ID D00585
MeSH ID D015735
PubChem ID 55245
TTD Drug ID D0Z4EI
NDC Product Code 44132-005; 44132-013; 65089-0043; 43393-001; 51508-011; 76346-073; 66499-0056; 69989-0003; 60722-3002
UNII 320T6RNW1F
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
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)
Nausea07.01.07.0010.002283%
Nervous system disorder17.02.10.001--Not Available
Oedema14.05.06.010; 08.01.07.0060.001097%Not Available
Oedema peripheral08.01.07.007; 02.05.04.007; 14.05.06.0110.000701%
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 syndrome24.08.04.009; 14.11.01.055; 05.03.01.004--Not Available
Pregnancy18.08.02.0040.001007%Not Available
Presyncope02.11.04.013; 24.06.02.010; 17.02.05.0090.000180%
Pruritus23.03.12.001--
Pyrexia08.05.02.0030.000180%
Rash23.03.13.001--Not Available
Rash maculo-papular23.03.13.004--
Sinusitis11.01.13.005; 22.07.03.007--
Skin disorder23.03.03.007--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.000180%
Tachycardia02.03.02.0070.000180%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; 11.07.01.006; 10.01.01.006--
Toxic shock syndrome24.06.02.015; 11.01.08.028--Not Available
Urticaria10.01.06.001; 23.04.02.001--
Uterine rupture21.07.01.009; 18.02.02.001; 12.01.15.001--Not Available
Vaginal discharge21.08.02.0020.000396%
Vaginal haemorrhage24.07.03.005; 21.08.01.0010.002679%
Vomiting07.01.07.0030.000881%
Acute generalised exanthematous pustulosis10.01.01.034; 23.03.10.002; 12.03.01.005; 11.07.01.0180.000360%Not Available
Uterine contractions during pregnancy18.08.02.005--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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