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What the label lists and what reports show

Methylprednisolone side effects

Methylprednisolone's FDA label lists its adverse reactions in its own words. FAERS holds 170,232 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (10,458 reports).

  • Generic listed
  • In shortage

Check it at the source: the methylprednisolone FDA label on DailyMed (effective June 22, 2026, Mylan Pharmaceuticals Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Fluid and Electrolyte Disturbances • Sodium retention • Congestive heart failure in susceptible patients • Hypertension • Fluid retention • Potassium loss • Hypokalemic alkalosis Musculoskeletal • Muscle weakness • Loss of muscle mass • Steroid myopathy • Osteoporosis • Tendon rupture, particularly of the Achilles tendon • Vertebral compression fractures • Aseptic necrosis of femoral and humeral heads • Pathologic fracture of long bones Gastrointestinal • Peptic ulcer with possible perforation and hemorrhage • Pancreatitis • Abdominal distention • Ulcerative esophagitis Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome, and reversible upon discontinuation.

Source: FDA drug label, NDA011153 (Pfizer), as published by Mylan Pharmaceuticals Inc., effective June 22, 2026 (SPL set 22dd75d6-f89a-44f7-8ca6-b64c4e9806dd), via openFDA; the full label on DailyMed

What do FAERS reports show?

170,232 reports list methylprednisolone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 27,470 are coded as a death and 70,067 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Off Label Use (a use or a product term, not a reaction)25,682
  • Drug Ineffective (a use or a product term, not a reaction)18,715
  • Fatigue10,458
  • Pain9,981
  • Nausea9,542
  • Headache (named in the label)9,503
  • Pyrexia9,146
  • Dyspnoea8,789
  • Arthralgia8,273
  • Pneumonia8,221
  • Diarrhoea8,069
  • Condition Aggravated (a use or a product term, not a reaction)7,642
  • Infusion Related Reaction7,293
  • Rash7,143
  • Hypertension (named in the label)6,654
  • Vomiting6,301
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)6,266
  • Malaise5,966
  • Rheumatoid Arthritis (a use or a product term, not a reaction)5,855
  • Asthenia5,674
  • Dizziness5,588
  • Cough5,308
  • Blood Pressure Increased5,163
  • Weight Increased5,098
  • Pruritus5,096

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Methylprednisolone: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions