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Drug side effects

methylprednisolone Side Effects

The reactions most often reported to the FDA for methylprednisolone (also sold as Medrol), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

131,747
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2000 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of methylprednisolone come from 131,747 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 131,747 reports to the FDA Adverse Event Reporting System (FAERS) for methylprednisolone (Medrol): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

131,747

Reports Mentioning Death

21,966

16.7% of reports — not proof the medicine caused the death

Hospitalizations

53,959

41.0% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

FATIGUE
7,793
PAIN
7,274
NAUSEA
7,213
HEADACHE
7,058
PYREXIA
6,883
PNEUMONIA
6,632
ARTHRALGIA
6,389
DYSPNOEA
6,339
DIARRHOEA
6,165
CONDITION AGGRAVATED
5,730
INFUSION RELATED REACTION
5,565
RASH
5,337
HYPERTENSION
5,102
VOMITING
4,616
RHEUMATOID ARTHRITIS
4,575
ASTHENIA
4,228
BLOOD PRESSURE INCREASED
4,194

Who Reports Side Effects

Gender Distribution

Female 65,011 (57%)
Male 48,445 (43%)
Unknown 401

Age Distribution

0-17 11,562 (12%)
18-44 25,852 (26%)
45-64 34,211 (35%)
65-74 17,083 (17%)
75+ 9,582 (10%)

Reporting Trend by Year

2000 2025

Reactions in Death Reports

Top reactions reported in 21,966 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 2,735
PNEUMONIA 2,287
RESPIRATORY FAILURE 1,624
CONDITION AGGRAVATED 1,600
SEPSIS 1,540
DIARRHOEA 1,464
MULTIPLE ORGAN DYSFUNCTION SYNDROME 1,459
PYREXIA 1,449
PAIN 1,440
GENERAL PHYSICAL HEALTH DETERIORATION 1,422
RASH 1,398
HYPERTENSION 1,362
SEPTIC SHOCK 1,324
DYSPNOEA 1,318
INFUSION RELATED REACTION 1,302
NAUSEA 1,245
FATIGUE 1,234

Reactions in Hospitalization Reports

Top reactions in 53,959 reports where hospitalization was an outcome.

Reaction Reports
PYREXIA 4,215
PNEUMONIA 4,210
NAUSEA 3,636
DYSPNOEA 3,531
DIARRHOEA 3,301
FATIGUE 3,246
PAIN 3,127
HEADACHE 3,015
CONDITION AGGRAVATED 3,005
VOMITING 2,890
ARTHRALGIA 2,751
ASTHENIA 2,507
RASH 2,328
MALAISE 2,324
HYPERTENSION 2,305
INFUSION RELATED REACTION 2,288
RHEUMATOID ARTHRITIS 1,984

Compare methylprednisolone vs abatacept →

What the FAERS Data Reveals About methylprednisolone Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 131,747 voluntary reports linked to methylprednisolone and its brand equivalents (Medrol), spanning 2000 through 2025. Of those, 21,966 (16.7%) listed death as an outcome and 53,959 (41.0%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 57% were female and 43% male; age distribution skews toward 45-64, with 34,211 reports in that bracket. The single most reported reaction is fatigue with 7,793 submissions, followed by pain and nausea.

How to read these numbers

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.

Drugs With a Similar FAERS Report Volume

Other medications with a total FDA adverse-event report count closest to methylprednisolone's 131,747.