Pharmacologic class (EPC) · 2 drug pages

Progestin antagonist: adverse event reports filed with FDA

5,227 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

5,227
reports across the class: 0% of all reports; 359
reports, 12 months to June 2026: 279 in the 12 months before; 55.6%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Progestin antagonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 5,227 adverse event reports received by FDA, 0% of the database, from August 2004 to June 2026.

359 reports arrived in the 12 months to June 2026, up 29% from 279 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 55.6% of the class's reports are marked serious, 6.1% record death among the outcomes and 29.9% record hospitalisation, as reported.

Across the class the reactions recorded most often are nausea (15.3%), haemorrhage (13.6%) and abortion incomplete (13.6%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
KorlymMifepristone	brand	3,055	233	63.1%	Nausea
Mifepristone	generic	2,172	126	45%	Abortion incomplete

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Nauseafeeling sick15.3%800
Haemorrhagebleeding13.6%713
Abortion incomplete13.6%709
Fatiguetiredness13.1%686
Dizzinesslight-headedness or unsteadiness8.7%455
Vomitingbeing sick8.6%451
Blood potassium decreased8.5%446
Headachehead pain7.6%395
Painpain, site not specified6.5%342
Blood pressure increaseda raised blood pressure reading6.5%341
Blood glucose increasedraised blood sugar reading5.8%301
Astheniaweakness or lack of energy5.6%293
Decreased appetitereduced appetite5.1%269
Blood glucose decreasedlow blood sugar reading5.1%265
Muscle spasmsmuscle cramps4.9%257
Peripheral swellingswelling of the arms or legs4.7%248
Anaemialow red blood cells4.6%242
Vaginal haemorrhagevaginal bleeding4.5%234
Arthralgiajoint pain4.4%228
Weight increasedweight gain4.2%222
Constipationconstipation4.2%220
Pregnancypregnancy4.1%212
Dyspnoeashortness of breath4%209
Oedema peripheralswelling of the legs, ankles or hands3.8%200
Malaisegeneral feeling of being unwell3.7%192

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death6.1%317

Life-threatening1.2%61

Hospitalisation (initial or prolonged)29.9%1,563

Disability0.5%27

Congenital anomaly0.9%48

Other serious32.5%1,700

Not serious44.4%2,321

Patient age

Under 20.2%8

2 to 110%0

12 to 170.8%42

18 to 4438.2%1,998

45 to 6413.8%723

65 to 746.6%343

75 and over2.2%114

Age not given38.2%1,999

Who reported

Physician13.4%702

Pharmacist0.7%38

Other health professional35.3%1,845

Lawyer0%0

Consumer or non-health professional47.2%2,465

Not given3.4%177

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Progestin antagonist reports

Which drugs are in the Progestin antagonist class on this site?

Korlym and Mifepristone. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

5,227 reports through June 2026, 359 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

nausea (15.3%), haemorrhage (13.6%), abortion incomplete (13.6%), fatigue (13.1%) and dizziness (8.7%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.