Medroxyprogesterone adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Medroxyprogesterone
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Progestin

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

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

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From February 2004 to June 2026, FDA received 3,030 adverse event reports that name Medroxyprogesterone. In these reports the drug is a suspect or interacting product.

In the same period, 2,314 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 165 reports in the 12 months to June 2026 and 165 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 165 (under 0.1%) name Medroxyprogesterone. Reports for female patients were 88.2% of the reports that name Medroxyprogesterone and 52.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Medroxyprogesterone is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 20 reports that name Medroxyprogesterone.
In January to March 2026, FDA received 81.
In April to June 2025, FDA received 48.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 140 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for all 3,030 reports.

The site keeps a term for a year only if two or more reports of that year record it.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 140 terms.

Reaction terms in the reports that name Medroxyprogesterone, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,030 reports
Breast cancer	941	31.1%
Breast cancer female	562	18.5%
Device leakagethe device leaked	250	8.3%
Drug dose omission by device	175	5.8%
Incorrect dose administered by devicethe device gave the wrong dose	150	5%
Syringe issue	148	4.9%
Device occlusionthe device blocked	133	4.4%
Needle issuea problem with the needle	91	3%
Breast cancer metastatic	90	3%
Oestrogen receptor assay positive	82	2.7%
Progesterone receptor assay positive	76	2.5%
Device issuea problem with the device	74	2.4%
Breast cancer in situ	53	1.7%
Ovarian cancer	52	1.7%
Drug ineffectivethe medicine did not work as expected	45	1.5%
Incorrect dose administeredthe wrong dose was given	43	1.4%
Device delivery system issuea problem with the delivery system	40	1.3%
Device mechanical issue	37	1.2%
Depressionlow mood	36	1.2%
Off label useused for a purpose or in a way not on the label	29	1%
Painpain, site not specified	27	0.9%
Product administration errora mistake in giving the product	25	0.8%
Accidental exposure to product	24	0.8%
Device malfunctionthe device did not work properly	24	0.8%
Dizzinesslight-headedness or unsteadiness	24	0.8%
Nauseafeeling sick	24	0.8%
Anxiety	23	0.8%
Arthralgiajoint pain	23	0.8%
Fatiguetiredness	23	0.8%
Meningioma	22	0.7%
Deep vein thrombosisa blood clot in a deep vein	20	0.7%
Pulmonary embolisma blood clot in the lung	20	0.7%
Astheniaweakness or lack of energy	19	0.6%
Cerebrovascular accidentstroke	19	0.6%
Product dose omission issuea dose was missed	18	0.6%
Vomitingbeing sick	18	0.6%
Exposure via skin contact	17	0.6%
Drug interactionan interaction between medicines	15	0.5%
Headachehead pain	15	0.5%
Insomniadifficulty sleeping	15	0.5%
Device physical property issuea physical problem with the device	14	0.5%
Osteopenia	14	0.5%
Alopeciahair loss	13	0.4%
Back pain	13	0.4%
Device difficult to usethe device was hard to use	13	0.4%
Disease recurrencethe disease came back	13	0.4%
Poor quality device used	13	0.4%
Chest pain	12	0.4%
Abdominal painstomach or belly pain	11	0.4%
Device defective	11	0.4%

Download all 140 terms of Medroxyprogesterone (CSV)

The counts add to more than 3,030 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Medroxyprogesterone with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Medroxyprogesterone (this page)	Generic name	3,030
Medroxyprogesterone acetate	Generic name	8,621
Depo-Provera	Brand name	18,669
Depo-SubQ Provera	Brand name	225
Provera	Brand name	20,400

Sum of the separately reported names: 50,945. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Medroxyprogesterone, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	139	139	2	0	58	2	1	129	0
2005	166	165	4	2	17	1	0	155	1
2006	342	331	9	1	21	1	0	321	11
2007	237	233	11	1	57	1	0	221	4
2008	467	461	12	1	62	2	0	449	6
2009	311	310	10	1	25	16	0	303	1
2010	118	116	8	1	20	6	0	112	2
2011	45	40	2	3	8	3	0	34	5
2012	38	33	2	2	8	3	1	27	5
2013	44	34	1	1	7	4	0	30	10
2014	26	14	0	1	3	2	1	10	12
2015	34	27	6	0	8	5	0	13	7
2016	17	12	2	1	6	1	0	7	5
2017	27	22	5	1	5	1	0	16	5
2018	22	14	1	1	3	0	0	13	8
2019	28	21	1	1	6	4	0	12	7
2020	38	28	0	2	16	1	0	17	10
2021	74	35	1	1	7	2	0	31	39
2022	282	25	0	4	2	0	0	21	257
2023	138	38	0	2	11	0	0	29	100
2024	151	36	0	0	7	1	0	32	115
2025	172	39	1	0	3	1	0	38	133
2026	114	64	2	3	16	2	0	51	50

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Medroxyprogesterone, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Medroxyprogesterone, by the year in which FDA received them
Year	Reports
2004	58
2005	203
2006	270
2007	208
2008	358
2009	345
2010	335
2011	68
2012	46
2013	18
2014	27
2015	36
2016	24
2017	27
2018	23
2019	30
2020	77
2021	76
2022	237
2023	157
2024	152
2025	154
2026	101

Reports that name Medroxyprogesterone, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Medroxyprogesterone
Age	Reports	Share
Under 2	2	0.1%
2 to 11	3	0.1%
12 to 17	39	1.3%
18 to 44	319	10.5%
45 to 64	807	26.6%
65 to 74	196	6.5%
75 and over	44	1.5%
Age not given	1,620	53.5%

Sex of the patient in the reports that name Medroxyprogesterone
Sex	Reports	Share
Female	2,673	88.2%
Male	39	1.3%
Unknown or not given	318	10.5%

Type of reporter in the reports that name Medroxyprogesterone
Reporter	Reports	Share
Physician	143	4.7%
Pharmacist	428	14.1%
Other health professional	416	13.7%
Lawyer	457	15.1%
Consumer or non-health professional	511	16.9%
Not given	1,075	35.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 68.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Medroxyprogesterone record
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 reporter fills in the indication, and the field is often empty. Each share is of all 3,030 reports.

Drugs in the same reports

Other drugs that the reports of Medroxyprogesterone name, in any role, in order of name
Drug	Reports that name the two
Aspirin	39
Climara	117
CombiPatch (estradiol/norethindrone acetate transdermal system)	32
Estrace	325
Estradiol	327
Hydrochlorothiazide	31
Medroxyprogesterone acetate	214
Premarin	1,483
Prempro	1,042
Vagifem	77

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Medroxyprogesterone acetate same ingredient
Depo-Provera same ingredient
Depo-SubQ Provera same ingredient
Provera same ingredient
Liletta same class
Levonorgestrel same class
Megestrol acetate same class
Kyleena same class
Mirena same class
Medrol next in the A to Z list
Mediator next in the A to Z list
Medroxyprogesterone and Medroxyprogesterone Acetate next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for MedroxyprogesteroneThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Medroxyprogesterone: adverse event reports that FDA received. https://reportedreactions.com/drug/medroxyprogesterone/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Medroxyprogesterone as a suspect or interacting product. The 2,314 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Medroxyprogesterone was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Medroxyprogesterone?

No. It is a count of what people reported to FDA: 3,030 reports from February 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (16.9%), lawyer (15.1%) and pharmacist (14.1%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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