Generic name
Medroxyprogesterone: adverse event reports filed with FDA
3,030 reports list it as a suspect or interacting product, 2004–2026. Class: Progestin.
- 3,030
- reports as suspect product
- 0% of all reports · about 135 a year
- 165
- reports, 12 months to June 2026
- 165 in the 12 months before
- 73.8%
- marked serious by the reporter
- 41.9% across the class
- 2.6%
- record death among outcomes, as reported
- 80 reports · not verified by FDA
3,030 adverse event reports received by FDA list medroxyprogesterone, a generic name as a suspect or interacting product, from February 2004 to June 2026. A further 2,314 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 165 reports listed it, close to the 165 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 135 reports a year and 0% of the 20,646,523 reports in the database, and 1% of the reports for the progestin class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded breast cancer (31.1%), breast cancer female (18.5%) and device leakage (8.3%). A report can list several reactions, so shares add to more than 100%; 380 different terms appear across these reports. Breast cancer is recorded in 31.1% of these reports, a larger share than in the median progestin drug (0.1%).
73.8% of the reports are marked serious by the reporter (41.9% across the class); 2.6% record death among the outcomes and 12.4% record hospitalisation, as reported. 16.9% of the reports came from consumers, and the largest patient age group is 45 to 64 (26.6%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Medroxyprogesterone reports recording the termmedian drug in progestin
- Breast cancerbreast cancer31.1%941
- Breast cancer female18.5%562
- Device leakagethe device leaked8.3%250
- Drug dose omission by device5.8%175
- Incorrect dose administered by devicethe device gave the wrong dose5%150
- Syringe issue4.9%148
- Device occlusionthe device blocked4.4%133
- Needle issuea problem with the needle3%91
- Oestrogen receptor assay positive2.7%82
- Progesterone receptor assay positive2.5%76
- Device issuea problem with the device2.4%74
- Breast cancer in situ1.7%53
- Ovarian cancer1.7%52
- Drug ineffectivethe medicine did not work as expected1.5%45
- Incorrect dose administeredthe wrong dose was given1.4%43
- Device delivery system issuea problem with the delivery system1.3%40
- Device mechanical issue1.2%37
- Depressionlow mood1.2%36
- Off label useused for a purpose or in a way not on the label1%29
- Painpain, site not specified0.9%27
- Product administration errora mistake in giving the product0.8%25
- Device malfunctionthe device did not work properly0.8%24
- Dizzinesslight-headedness or unsteadiness0.8%24
- Nauseafeeling sick0.8%24
- Anxietyanxiety0.8%23
- Arthralgiajoint pain0.8%23
- Fatiguetiredness0.8%23
- Meningioma0.7%22
Top 30 of 380 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 68.4% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hormone replacement therapy | 796 | 26.3% |
| Contraception | 384 | 12.7% |
| Menopausal symptoms | 100 | 3.3% |
| Menopause | 30 | 1% |
| Breast cancer | 13 | 0.4% |
| Uterine haemorrhage | 11 | 0.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 3,030 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Medroxyprogesterone reports |
|---|---|---|
| Premarin | 1,483 | 48.9% |
| Prempro | 1,042 | 34.4% |
| Estradiol | 327 | 10.8% |
| Estrace | 325 | 10.7% |
| Medroxyprogesterone acetate | 214 | 7.1% |
| Climara | 117 | 3.9% |
| Vagifem | 77 | 2.5% |
| Aspirin | 39 | 1.3% |
| CombiPatch (estradiol/norethindrone acetate transdermal system) | 32 | 1.1% |
| Hydrochlorothiazide | 31 | 1% |
Other products listed in reports where Medroxyprogesterone is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Medroxyprogesterone | Progestin | All reports |
|---|---|---|---|
| Reports as suspect product | 3,030 | 293,492 | 20,646,523 |
| Share of that pool | — | 1% | 0% |
| Reports, latest 12 months | 165 | — | 1,332,454 |
| Marked serious | 73.8% | 41.9% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 26 | 4 | 91 |
| Hospitalisation recorded, per 1,000 reports | 124 | 52 | 213 |
| Consumer-filed share | 16.9% | 46.4% | 45.8% |
| Top term, share of reports | Breast cancer 31.1% | median 0.1% | 0.4% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Mirena | brand | 129,479 | 3,433 | 40.6% |
| Nexplanon | brand | 43,751 | 836 | 24.8% |
| Plan B One-Step | brand | 35,324 | 327 | 4.9% |
| Provera | brand | 20,400 | 26 | 98.6% |
| Depo-Provera | brand | 18,669 | 11,383 | 87.1% |
| Liletta | brand | 10,567 | 850 | 8.2% |
| Medroxyprogesterone acetate | generic | 8,621 | 818 | 89% |
| Kyleena | brand | 8,075 | 694 | 40.4% |
| Skyla | brand | 5,310 | 125 | 41.7% |
| Levonorgestrel | generic | 2,711 | 219 | 72.2% |
| Take Action | brand | 2,550 | 20 | 8.1% |
| Etonogestrel | generic | 2,112 | 255 | 89.7% |
| Aftera | brand | 818 | 19 | 5% |
| Norethindrone | generic | 797 | 52 | 52.1% |
| Norethindrone acetate | generic | 722 | 8 | 35.9% |
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.
Questions about Medroxyprogesterone reports
How many adverse event reports has FDA received for Medroxyprogesterone?
3,030 reports list Medroxyprogesterone as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 165 of them arrived in the latest 12 months. Another 2,314 list it only as a concomitant medication.
What reactions are recorded in Medroxyprogesterone reports?
breast cancer (31.1%), breast cancer female (18.5%), device leakage (8.3%), drug dose omission by device (5.8%) and incorrect dose administered by device (5%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Medroxyprogesterone was responsible.
How serious are the reports?
73.8% are marked serious by the reporter. Among the outcomes recorded, 2.6% of reports include death and 12.4% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
not given (35.5%), consumer or non-health professional (16.9%) and lawyer (15.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Medroxyprogesterone rising?
165 reports in the 12 months to June 2026, close to the 165 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Medroxyprogesterone was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Medroxyprogesterone?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Medroxyprogesterone as a suspect or interacting product; reports listing it only as a concomitant medication (2,314) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.