Proveramedroxyprogesterone
According to the FDA label: Medroxyprogesterone Acetate Tablets USP are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.
27,922 adverse event reports submitted to the FDA (1997–2026)
Top Reported Adverse Events
The most frequently reported events in association with Provera in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Breast Cancer Female 9,758 reports
A report of breast cancer in a female patient. It may appear in reports as a condition being treated or monitored, not necessarily as a reaction.
Full definition in the glossary →Breast Cancer 8,138 reports
A cancer that forms in the tissue of the breast. It may appear in reports as a condition being treated or monitored.
Full definition in the glossary →Breast Cancer Metastatic 1,380 reports
Breast cancer that has spread to other parts of the body. It may appear in reports as a condition being treated.
Full definition in the glossary →- Oestrogen Receptor Assay Positive 773 reports
- Progesterone Receptor Assay Positive 673 reports
- Meningioma 546 reports
- Breast Cancer In Situ 516 reports
Pain 512 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Drug Ineffective 508 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →- Ovarian Cancer 494 reports
Nausea 467 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fatigue 440 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Anxiety 389 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Cerebrovascular Accident 389 reports
The medical term for a stroke, which happens when blood flow to part of the brain is interrupted.
Full definition in the glossary →Headache 389 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 26,908 |
| Male | 229 |
| Unknown | 39 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 218 |
| 18-34 | 1,014 |
| 35-49 | 1,467 |
| 50-64 | 5,608 |
| 65-74 | 1,750 |
| 75+ | 379 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Provera. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 24,405 |
| Hospitalization | 3,095 |
| Non-Serious | 2,238 |
| Death | 810 |
| Disability | 634 |
| Life-Threatening | 223 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Provera. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 1997 | 1 |
| 2004 | 3,216 |
| 2005 | 2,334 |
| 2006 | 1,804 |
| 2007 | 813 |
| 2008 | 1,984 |
| 2009 | 3,952 |
| 2010 | 6,980 |
| 2011 | 1,312 |
| 2012 | 567 |
| 2013 | 249 |
| 2014 | 234 |
| 2015 | 296 |
| 2016 | 316 |
| 2017 | 264 |
| 2018 | 299 |
| 2019 | 368 |
| 2020 | 408 |
| 2021 | 320 |
| 2022 | 301 |
| 2023 | 314 |
| 2024 | 442 |
| 2025 | 879 |
| 2026 (partial) | 269 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Provera
In FDA adverse event reports that mention Provera, these medications appeared most often in the same report.
- Conjugated Estrogens And Medroxyprogesterone (12,499 reports)
- Estradiol (3,851 reports)
- Estradiol % (1,685 reports)
- Estradiol Transdermal (1,685 reports)
- Levothyroxine (1,146 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026