Provera: adverse event reports filed with FDA

20,400

reports as suspect product

0.1% of all reports · about 907 a year

26

reports, 12 months to June 2026

30 in the 12 months before

98.6%

marked serious by the reporter

41.9% across the class

2.5%

record death among outcomes, as reported

513 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Provera reports recording the termmedian drug in progestin

1. Breast cancer female44.6%9,108
2. Breast cancerbreast cancer37.1%7,576
3. Breast cancer metastatic5.9%1,211
4. Oestrogen receptor assay positive3.5%715
5. Progesterone receptor assay positive3.1%631
6. Breast cancer in situ2.3%472
7. Ovarian cancer1.9%396
8. Cerebrovascular accidentstroke1.4%282
9. Deep vein thrombosisa blood clot in a deep vein1.1%231
10. Anxietyanxiety0.9%174
11. Myocardial infarctionheart attack0.8%173
12. Depressionlow mood0.8%171
13. Pulmonary embolisma blood clot in the lung0.8%167
14. Thrombosis0.8%164
15. Painpain, site not specified0.6%122
16. Breast cancer recurrent0.5%111
17. Mastectomy0.5%103
18. Breast operation0.5%101
19. Contralateral breast cancer0.4%84
20. Hypertensionhigh blood pressure0.4%75
21. Breast mass0.4%74
22. Headachehead pain0.4%72
23. Fatiguetiredness0.3%70
24. Injurya physical injury0.3%64
25. Lymphoedema0.3%64
26. Ovarian cancer metastatic0.3%63
27. Endometrial cancer0.3%61
28. Metastases to lymph nodes0.3%61
29. Drug hypersensitivityan allergic-type reaction to a medicine0.3%59
30. Drug ineffectivethe medicine did not work as expected0.3%58

Top 30 of 612 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 17 drugs in the progestin class; it describes the reports, not the patients. 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."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 293,492 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 80.4% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 20,400 reports.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."

Other drugs in the progestin class

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." A brand and its generic are separate rows because reporters name them separately.

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 report counts here when it lists Provera as a suspect or interacting product; reports listing it only as a concomitant medication (2,205) are excluded. 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.