MEDROL FDA MedWatch Direct Reports Summary

These tables and charts are created from 1,079 voluntary U.S. reports for MEDROL (METHYLPREDNISOLONE) 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 MEDROL Report.

Top Adverse Effects Associated with MEDROL (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	INFUSION RELATED REACTION	69
2	SHORTNESS OF BREATH	66
3	HEADACHE	63
4	NAUSEA	58
5	PAIN	56
6	FATIGUE	41
7	DIZZINESS	39
8	ITCHING	36
9	JOINT PAIN	35
10	FEVER	35
11	PAIN IN EXTREMITY	34
12	RASH	34
13	DIARRHEA	30
14	INSOMNIA	30
15	VOMITING	30
16	CHEST DISCOMFORT	29
17	DRUG INEFFECTIVE	29
18	FLUSHING	29
19	ANXIETY	27
20	BACK PAIN	27
21	SKIN REDNESS	27
22	NUMBNESS	27
23	HIVES	25
24	LACK OF STRENGTH AND ENERGY (ASTHENIA)	24
25	CONDITION AGGRAVATED	24

Search all MedWatch Reports by Keyword:

MEDROL Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
357	650	72	1,079

Medwatch Reporter Type	Count
Consumer	224
Physician	112
Pharmacist	272
Other Health Professional	241
Lawyer	2

Top Indications

Back pain
Asthma
Bronchitis
Rheumatoid arthritis
Chronic graft versus host disease

Type of Outcome Reported
Serious: 720
Not Serious: 359
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: 1079
Concomitant Drugs: 753
Note: A single MedWatch report can list more than one drug. This summary includes MEDROL identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

MEDROL (METHYLPREDNISOLONE) Rx Drug:
FDA Safety-related Labeling Changes

Risk of infection with various pathogens, including viral, bacterial, fungal, protozoan, or helminthic (parasitic); flushing risk

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