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

These tables and charts are based on 4,531 total reports for DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 4,314 pharmaceutical company-submitted and non-U.S. FAERS reports and 217 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 217 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch DEPO-MEDROL summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	PAIN	803
2	DRUG INEFFECTIVE	726
3	RHEUMATOID ARTHRITIS	616
4	JOINT PAIN	613
5	FATIGUE	597
6	JOINT SWELLING	568
7	NAUSEA	522
8	MALAISE	491
9	PAIN IN EXTREMITY	474
10	MUSCULOSKELETAL STIFFNESS	452
11	HEADACHE	430
12	OFF LABEL USE	416
13	DIARRHEA	357
14	LOWER LIMBS SWELLING	346
15	DIZZINESS	334
16	DRUG INTOLERANCE	321
17	MUSCULAR WEAKNESS	311
18	ANXIETY	295
19	ARTHRITIS	288
20	CONDITION AGGRAVATED	277
21	SHORTNESS OF BREATH	277
22	FEVER	265
23	MUSCULOSKELETAL PAIN	250
24	PNEUMONIA	249
25	BLOOD PRESSURE INCREASED	243
26	LACK OF STRENGTH AND ENERGY (ASTHENIA)	242
27	DRUG HYPERSENSITIVITY	242
28	FIBROMYALGIA	238
29	RASH	238
30	VOMITING	237
31	CATARACT	236
32	COUGH	236
33	FALL	232
34	FEELING ABNORMAL	230
35	MUSCLE PAIN	224
36	BACK PAIN	223
37	GASTROINTESTINAL DISORDER	223
38	DRY EYE	221
39	TREATMENT FAILURE	221
40	SINUSITIS	217
41	JOINT RANGE OF MOTION DECREASED	208
42	PALPITATIONS	199
43	JOINT INFLAMMATION	198
44	SYNOVIAL CYST	197
45	ITCHING	189
46	C-REACTIVE PROTEIN INCREASED	186
47	HAND DEFORMITY	184
48	WEIGHT INCREASED	175
49	ITCHY RASH	174
50	HIGH BLOOD PRESSURE	172
51	PULMONARY TOXICITY	169
52	CHEST DISCOMFORT	164
53	INFECTION	164
54	TENOSYNOVITIS	163
55	SKIN REDNESS	162
56	RASH MACULO-PAPULAR	161
57	BONE DENSITY DECREASED	160
58	ABDOMINAL PAIN	158
59	UPPER RESPIRATORY TRACT INFECTION	158
60	OSTEOARTHRITIS	155
61	CONFUSIONAL STATE	152
62	NUMBNESS	152
63	TENDERNESS	151
64	DIFFICULTY SWALLOWING	150
65	PSORIASIS	150
66	ANGINA ATTACK	147
67	THERAPEUTIC PRODUCT EFFECT DECREASED	147
68	COMMON COLD	145
69	WEIGHT DECREASED	145
70	CREPITATIONS	141
71	JOINT PAIN	140
72	RHEUMATOID NODULE	138
73	SWELLING	138
74	STROKE	136
75	MOBILITY DECREASED	136
76	INSOMNIA	133
77	PRODUCT USE ISSUE	133
78	JOINT EFFUSION	131
79	ARTERIAL OCCLUSIVE DISEASE	127
80	GANGRENE	125
81	GAIT DISTURBANCE	124
82	LIVER DISORDER	124
83	INFLUENZA LIKE ILLNESS	119
84	INFLUENZA	116
85	RUNNY NOSE	115
86	COMMUNICATION DISORDER (APHASIA)	113
87	SLURRED SPEECH	113
88	SENSORY LOSS	113
89	CONTRAINDICATED PRODUCT ADMINISTERED	112
90	PINS AND NEEDLES	112
91	MUSCLE SPASMS	111
92	DEFORMITY	110
93	CYSTITIS	109
94	INFLAMMATION	109
95	CHEST PAIN	108
96	HYPERSENSITIVITY	108
97	SKIN PEELING	108
98	LUNG DISORDER	107
99	VISUAL IMPAIRMENT	106
100	ALLERGY TO CHEMICALS	104

Latest Known Outcomes for Reactions Reported for DEPO-MEDROL

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	2201
2	Patient has not recovered/symtoms have not resolved	1065
3	Patient recovered	794
4	Patient is recovering/symptoms resolving	320
5	Patient died	167
6	Patient has recovered but has consequent health issues	51

Search all MedWatch and FAERS by keyword:

DEPO-MEDROL Total Reports

Male	Female	Unknown	Total
1229	2789	513	4,531

Top Countries Reporting

	Country	Number of Reports
1	United States	1681
2	Canada	1224
3	France	265
4	Denmark	52
5	Italy	41
6	Belgium	35
7	Netherlands	24
8	EU	21
9	Australia	16
10	Sweden	16

Outcomes for Reports

Serious: 3668
Not Serious: 863
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

Cervical radiculopathy
Back pain
Inflammation
Hypersensitivity
Bursitis

Top Companies Reporting

PFIZER

Safety-Related FDA Updates

DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) Rx Drug:
Risk of infection with various pathogens, including viral, bacterial, fungal, protozoan, or helminthic (parasitic); flushing risk Safety-related Labeling Changes

Have experience (good or bad) with DEPO-MEDROL? Rate DEPO-MEDROL 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-MEDROL 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.