methylprednisolone Side Effects
Also known as: Medrol
Analysis of 131,747 adverse event reports submitted to the FDA from 2000 to 2025.
Total Reports
131,747
Death-Related
21,966
16.7% of reports
Hospitalizations
53,959
41.0% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
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 |
|---|---|
| OFF LABEL USE | 3,812 |
| DRUG INEFFECTIVE | 3,246 |
| DEATH | 2,735 |
| PNEUMONIA | 2,287 |
| RESPIRATORY FAILURE | 1,624 |
| CONDITION AGGRAVATED | 1,600 |
| PRODUCT USE IN UNAPPROVED INDICATION | 1,546 |
| 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 |
|---|---|
| OFF LABEL USE | 8,139 |
| DRUG INEFFECTIVE | 6,639 |
| 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 |
| PRODUCT USE IN UNAPPROVED INDICATION | 2,033 |
| RHEUMATOID ARTHRITIS | 1,984 |
Nearby — Related Medications
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 off label use with 20,939 submissions, followed by drug ineffective and fatigue.
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.
Read our methodology — how this data is sourced, computed, and verified.