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What the label lists and what reports show

Cortisone side effects

Cortisone's FDA label lists its adverse reactions in its own words. FAERS holds 12,274 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 pain (6,211 reports).

  • Generic listed

Check it at the source: the cortisone FDA label on DailyMed (effective June 6, 2025, Chartwell RX, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Fluid and Electrolyte Disturbances Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal Muscle weakness Steroid myopathy Loss of muscle mass Osteoporosis Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Pathologic fracture of long bones Tendon rupture Gastrointestinal Peptic ulcer with possible perforation and hemorrhage Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease Pancreatitis Abdominal distention Ulcerative esophagitis Dermatologic Impaired wound healing Thin fragile skin Petechiae and ecchymoses Erythema Increased sweating May suppress reactions to skin tests Other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edema Neurologic Convulsions Increased intracranial pressure with …

Source: FDA drug label, Chartwell RX, LLC, effective June 6, 2025 (SPL set cc158d11-f356-4696-8b73-5d2681dcbcf2), via openFDA; the full label on DailyMed

What do FAERS reports show?

12,274 reports list cortisone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,750 are coded as a death and 5,225 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 18 reactions below, 1 is 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

  • Systemic Lupus Erythematosus (a use or a product term, not a reaction)6,277
  • Pain6,211
  • Pemphigus (a use or a product term, not a reaction)6,161
  • Drug Ineffective (a use or a product term, not a reaction)6,130
  • Alopecia6,061
  • Rheumatoid Arthritis (a use or a product term, not a reaction)6,021
  • Abdominal Discomfort5,958
  • Fatigue5,674
  • Glossodynia5,549
  • Swelling5,415
  • Hand Deformity5,139
  • Wound (named in the label)4,979
  • Rash4,954
  • Arthropathy4,802
  • Contraindicated Product Administered4,543
  • Infusion Related Reaction4,497
  • Pericarditis4,474
  • Synovitis (a use or a product term, not a reaction)4,441
  • Maternal Exposure During Pregnancy (a use or a product term, not a reaction)4,344
  • Hypersensitivity (a use or a product term, not a reaction)4,343
  • Drug Intolerance4,321
  • Joint Swelling4,284
  • Hepatic Enzyme Increased4,134
  • Discomfort4,032
  • Anti-Cyclic Citrullinated Peptide Antibody Positive3,897

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

What next?

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