Depo-subq 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.
9,615 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Depo-subq 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.
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Breast Cancer Female 2,993 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 1,819 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 →- Meningioma 537 reports
Breast Cancer Metastatic 434 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 →Drug Ineffective 302 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 →Off Label Use 218 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →- Oestrogen Receptor Assay Positive 215 reports
Pain 194 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →- Ovarian Cancer 184 reports
Nausea 180 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →- Progesterone Receptor Assay Positive 178 reports
Fatigue 162 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Headache 152 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Vomiting 148 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →- Breast Cancer In Situ 137 reports
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 | 8,993 |
| Male | 138 |
| Unknown | 7 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 153 |
| 18-34 | 653 |
| 35-49 | 625 |
| 50-64 | 1,424 |
| 65-74 | 410 |
| 75+ | 103 |
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 Depo-subq 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 | 7,765 |
| Non-Serious | 1,289 |
| Hospitalization | 1,143 |
| Death | 306 |
| Disability | 212 |
| Life-Threatening | 108 |
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 Depo-subq 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 |
|---|---|
| 2004 | 1,186 |
| 2005 | 855 |
| 2006 | 782 |
| 2007 | 199 |
| 2008 | 300 |
| 2009 | 481 |
| 2010 | 1,840 |
| 2011 | 504 |
| 2012 | 280 |
| 2013 | 89 |
| 2014 | 72 |
| 2015 | 123 |
| 2016 | 122 |
| 2017 | 113 |
| 2018 | 153 |
| 2019 | 217 |
| 2020 | 272 |
| 2021 | 212 |
| 2022 | 200 |
| 2023 | 239 |
| 2024 | 344 |
| 2025 | 789 |
| 2026 (partial) | 243 |
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 Depo-subq Provera
In FDA adverse event reports that mention Depo-subq Provera, these medications appeared most often in the same report.
- Conjugated Estrogens And Medroxyprogesterone (3,194 reports)
- Estradiol (1,366 reports)
- Estradiol % (834 reports)
- Estradiol Transdermal (834 reports)
- Levothyroxine (319 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