FDA Adverse Events Reports (FAERS) Summary for DEPO-PROVERA

These tables and charts are based on 15,204 total reports for DEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 14,709 pharmaceutical company-submitted and non-U.S. FAERS reports and 495 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 495 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch DEPO-PROVERA summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with DEPO-PROVERA (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	MENINGIOMA	2803
2	HEADACHE	730
3	DRUG INEFFECTIVE	728
4	WEIGHT INCREASED	705
5	NAUSEA	683
6	UNINTENDED PREGNANCY	647
7	ABSENCE OF MENSTRUATION	610
8	DEPRESSION	593
9	PAIN	575
10	FATIGUE	527
11	DIZZINESS	521
12	ANXIETY	455
13	MENORRHAGIA	423
14	MENINGIOMA BENIGN	422
15	OFF LABEL USE	421
16	METRORRHAGIA	413
17	OSTEOPOROSIS	407
18	SHORTNESS OF BREATH	400
19	VOMITING	379
20	ABDOMINAL PAIN	371
21	MALAISE	300
22	BACK PAIN	298
23	JOINT PAIN	296
24	VAGINAL HAEMORRHAGE	293
25	DRUG DOSE OMISSION BY DEVICE	284
26	MIGRAINE	280
27	HAIR LOSS	279
28	INJECTION SITE PAIN	272
29	INSOMNIA	265
30	INCORRECT DOSE ADMINISTERED BY DEVICE	254
31	PAIN IN EXTREMITY	254
32	DIARRHEA	253
33	MISCARRIAGE	243
34	ITCHING	237
35	FEELING ABNORMAL	232
36	RASH	227
37	OSTEOPENIA	225
38	DEVICE LEAKAGE	224
39	LACK OF STRENGTH AND ENERGY (ASTHENIA)	221
40	WEIGHT DECREASED	220
41	CONDITION AGGRAVATED	217
42	BLEEDING	213
43	NEEDLE ISSUE	213
44	DRUG EXPOSURE DURING PREGNANCY	206
45	DEVICE ISSUE	204
46	CHEST PAIN	202
47	MUSCLE SPASMS	201
48	HIVES	198
49	PULMONARY EMBOLISM	190
50	MOOD SWINGS	184
51	SUICIDAL IDEATION	183
52	SYRINGE ISSUE	183
53	HYPERSENSITIVITY	181
54	HIGH BLOOD PRESSURE	181
55	ABDOMINAL PAIN UPPER	180
56	NUMBNESS	177
57	IRREGULAR PERIODS	168
58	PRODUCT ADMINISTRATION ERROR	163
59	ABDOMINAL DISTENSION	162
60	INJURY	160
61	DEVICE OCCLUSION	158
62	HOT FLUSH	155
63	FEVER	154
64	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	152
65	PINS AND NEEDLES	151
66	PREGNANCY WITH INJECTABLE CONTRACEPTIVE	151
67	INCORRECT DOSE ADMINISTERED	146
68	FALL	134
69	EXCESS SWEATING	134
70	DROWSINESS	134
71	URINARY TRACT INFECTION	134
72	SEIZURE	132
73	ACNE	131
74	EMOTIONAL DISTRESS	131
75	PELVIC PAIN	130
76	TREMOR	129
77	PALPITATIONS	128
78	ANEMIA	126
79	MATERNAL EXPOSURE DURING PREGNANCY	122
80	BONE DENSITY DECREASED	118
81	PAINFUL PERIODS	118
82	GAIT DISTURBANCE	115
83	DECREASED APPETITE	114
84	DRUG HYPERSENSITIVITY	114
85	SKIN REDNESS	114
86	LOSS OF CONSCIOUSNESS	114
87	MUSCLE PAIN	112
88	FAINTING	112
89	VISION BLURRED	112
90	IRRITABILITY	109
91	NERVOUSNESS	109
92	PRODUCT USE ISSUE	108
93	CONSTIPATION	102
94	DRUG INTERACTION	101
95	PRODUCT USE IN UNAPPROVED INDICATION	99
96	INFERTILITY FEMALE	98
97	PANIC ATTACK	98
98	THROMBOSIS	98
99	STROKE	95
100	SWELLING	95

Latest Known Outcomes for Reactions Reported for DEPO-PROVERA

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	7253
2	Patient has not recovered/symtoms have not resolved	2789
3	Patient recovered	1624
4	Patient is recovering/symptoms resolving	665
5	Patient died	121
6	Patient has recovered but has consequent health issues	117

Search all MedWatch and FAERS by keyword:

DEPO-PROVERA Total Reports

Male	Female	Unknown	Total
134	13758	1312	15,204

Top Countries Reporting

	Country	Number of Reports
1	United States	8216
2	United Kingdom	840
3	Canada	585
4	Brazil	258
5	Netherlands	145
6	EU	72
7	Sweden	61
8	Australia	49
9	Puerto Rico	43
10	South Africa	37

Outcomes for Reports

Serious: 10839
Not Serious: 4364
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Contraception
Endometriosis
Hormone level abnormal
Heavy menstrual bleeding
BLEEDING

Top Companies Reporting

PFIZER

Safety-Related FDA Updates

DEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) Rx Drug:
Added warning about increased risk of developing brain tumor (meningioma). Usually benign. Safety-related Labeling Changes

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 the cases for DEPO-PROVERA reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. 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. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "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."

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 or comments about this report.