DEPO-PROVERA FDA MedWatch Direct Reports Summary

These tables and charts are created from 495 voluntary U.S. reports for DEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS DEPO-PROVERA Report.

Top Adverse Effects Associated with DEPO-PROVERA (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	DEPRESSION	51
2	FATIGUE	48
3	HEADACHE	44
4	WEIGHT INCREASED	38
5	NAUSEA	34
6	ANXIETY	32
7	DIZZINESS	31
8	PAIN	31
9	SHORTNESS OF BREATH	26
10	MENORRHAGIA	25
11	SUICIDAL IDEATION	25
12	MOOD SWINGS	24
13	INSOMNIA	22
14	HAIR LOSS	21
15	VAGINAL HAEMORRHAGE	20
16	DRUG INEFFECTIVE	19
17	BACK PAIN	18
18	MIGRAINE	18
19	FEELING ABNORMAL	16
20	HOT FLUSH	16
21	BLEEDING	15
22	PREGNANCY WITH INJECTABLE CONTRACEPTIVE	15
23	ABSENCE OF MENSTRUATION	14
24	ANGER	14
25	LACK OF STRENGTH AND ENERGY (ASTHENIA)	14

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DEPO-PROVERA Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
5	453	42	495

Medwatch Reporter Type	Count
Consumer	237
Physician	14
Pharmacist	47
Other Health Professional	61

Top Indications

Contraception
Endometriosis
Hormone level abnormal
Heavy menstrual bleeding
BLEEDING

Type of Outcome Reported
Serious: 349
Not Serious: 146
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 495
Concomitant Drugs: 248
Note: A single MedWatch report can list more than one drug. This summary includes DEPO-PROVERA identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

DEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) Rx Drug:
FDA Safety-related Labeling Changes

Added warning about increased risk of developing brain tumor (meningioma). Usually benign.

Have experience (good or bad) with DEPO-PROVERA? Rate DEPO-PROVERA at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.