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MIFEPRISTONE

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Mifepristone Adverse Events Reported to the FDA Over Time

How are Mifepristone adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Mifepristone, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Mifepristone is flagged as the suspect drug causing the adverse event.

Most Common Mifepristone Adverse Events Reported to the FDA

What are the most common Mifepristone adverse events reported to the FDA?

Abortion Incomplete
884 (15.89%)
Haemorrhage
880 (15.82%)
Anaemia
361 (6.49%)
Pregnancy
318 (5.72%)
Menorrhagia
243 (4.37%)
Muscle Spasms
208 (3.74%)
Abdominal Pain
166 (2.98%)
Pain
158 (2.84%)
Dizziness
155 (2.79%)
Pyrexia
148 (2.66%)
Vomiting
135 (2.43%)
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Nausea
113 (2.03%)
Syncope
106 (1.91%)
Endometritis
105 (1.89%)
Drug Exposure During Pregnancy
72 (1.29%)
Infection
53 (.95%)
Asthenia
46 (.83%)
Chills
44 (.79%)
Hypotension
37 (.66%)
Pelvic Pain
36 (.65%)
Ectopic Pregnancy
35 (.63%)
Headache
32 (.58%)
Vaginal Haemorrhage
29 (.52%)
Pelvic Inflammatory Disease
28 (.5%)
Fatigue
25 (.45%)
Ruptured Ectopic Pregnancy
24 (.43%)
Sepsis
23 (.41%)
Tachycardia
23 (.41%)
Hypersensitivity
22 (.4%)
Dyspnoea
21 (.38%)
Diarrhoea
17 (.31%)
Uterine Haemorrhage
16 (.29%)
Back Pain
14 (.25%)
Breast Tenderness
14 (.25%)
Antepartum Haemorrhage
13 (.23%)
Haemoglobin Decreased
13 (.23%)
Intra-uterine Death
13 (.23%)
Death
12 (.22%)
Induced Abortion Failed
12 (.22%)
Post Abortion Infection
12 (.22%)
Caesarean Section
11 (.2%)
Dysuria
11 (.2%)
Urinary Tract Infection
11 (.2%)
White Blood Cell Count Increased
11 (.2%)
Uterine Disorder
10 (.18%)
Chest Pain
9 (.16%)
Drug Ineffective
9 (.16%)
Loss Of Consciousness
9 (.16%)
Malaise
9 (.16%)
Oligohydramnios
9 (.16%)
Retained Products Of Conception
9 (.16%)
Vaginal Odour
9 (.16%)
Abortion Induced
8 (.14%)
Drug Ineffective For Unapproved Ind...
8 (.14%)
Incorrect Dose Administered
8 (.14%)
Leukocytosis
8 (.14%)
Necrosis
8 (.14%)
Off Label Use
8 (.14%)
Rash
8 (.14%)
Dehydration
7 (.13%)
Dysmenorrhoea
7 (.13%)
Hyperhidrosis
7 (.13%)
Incorrect Route Of Drug Administrat...
7 (.13%)
Orthostatic Hypotension
7 (.13%)
Post Abortion Complication
7 (.13%)
Pulmonary Embolism
7 (.13%)
Thrombosis
7 (.13%)
Treatment Noncompliance
7 (.13%)
Urticaria
7 (.13%)
Vaginitis Bacterial
7 (.13%)
Cardiac Arrest
6 (.11%)
Clostridial Infection
6 (.11%)
Convulsion
6 (.11%)
Hot Flush
6 (.11%)
Myometritis
6 (.11%)
Premature Baby
6 (.11%)
Swelling Face
6 (.11%)
Unevaluable Event
6 (.11%)
Vaginal Discharge
6 (.11%)
Abortion Complete
5 (.09%)
Ascites
5 (.09%)
Bacterial Infection
5 (.09%)
Cardio-respiratory Arrest
5 (.09%)
Gestational Diabetes
5 (.09%)
Haematocrit Decreased
5 (.09%)
Inflammation
5 (.09%)
Menstruation Irregular
5 (.09%)
Metrorrhagia
5 (.09%)
Pelvic Infection
5 (.09%)
Skin Odour Abnormal
5 (.09%)
Toxic Shock Syndrome
5 (.09%)
Abdominal Pain Lower
4 (.07%)
Abortion Infected
4 (.07%)
Anorexia
4 (.07%)
Arteriospasm Coronary
4 (.07%)
Deep Vein Thrombosis
4 (.07%)
Escherichia Infection
4 (.07%)
Fallopian Tube Disorder
4 (.07%)
Foetal Arrhythmia
4 (.07%)
Foetal Cardiac Disorder
4 (.07%)
Heart Rate Increased
4 (.07%)

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This graph shows the top adverse events submitted to the FDA for Mifepristone, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Mifepristone is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Mifepristone

What are the most common Mifepristone adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Mifepristone, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Mifepristone is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Mifepristone According to Those Reporting Adverse Events

Why are people taking Mifepristone, according to those reporting adverse events to the FDA?

Abortion Induced
2314
Abortion
17
Ill-defined Disorder
9
Cushings Syndrome
4
Product Used For Unknown Indication
4
Induced Labour
4
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Oral Contraception
2
Pregnancy
2
Drug Exposure During Pregnancy
2
Drug Use For Unknown Indication
2
Diabetes Mellitus
1
Uterine Leiomyoma
1

Drug Labels

LabelLabelerEffective
KorlymCorcept Inc22-FEB-12

Mifepristone Case Reports

What Mifepristone safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Mifepristone. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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