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What the label lists and what reports show

Prednisolone side effects

Prednisolone's FDA label lists its adverse reactions in its own words. FAERS holds 191,407 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 pyrexia (8,820 reports).

  • Generic listed

Check it at the source: the prednisolone FDA label on DailyMed (effective June 25, 2026, PAI Holdings, LLC dba PAI Pharma); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

(listed alphabetically under each subsection): Cardiovascular: Hypertrophic cardiomyopathy in premature infants. Dermatologic: Facial erythema; increased sweating; impaired wound healing; may suppress reactions to skin tests; petechiae and ecchymoses; thin fragile skin; urticaria; edema. Endocrine: Decreased carbohydrate tolerance; development of cushingoid state; hirsutism; increased requirements for insulin or oral hypoglycemic agents in diabetic patients; manifestations of latent diabetes mellitus; menstrual irregularities; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness; suppression of growth in children. Fluid and Electrolyte Disturbances: Congestive heart failure in susceptible patients; fluid retention; hypertension; hypokalemic alkalosis; potassium loss; sodium retention. …

Source: FDA drug label, PAI Holdings, LLC dba PAI Pharma, effective June 25, 2026 (SPL set d1f937e7-fed5-4079-bd52-5d930b34ae9f), via openFDA; the full label on DailyMed

What do FAERS reports show?

191,407 reports list prednisolone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 29,606 are coded as a death and 84,722 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, 4 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)16,339
  • Drug Ineffective (a use or a product term, not a reaction)13,824
  • Pyrexia8,820
  • Dyspnoea7,428
  • Pneumonia (a use or a product term, not a reaction)7,315
  • Diarrhoea7,102
  • Condition Aggravated (a use or a product term, not a reaction)6,364
  • Nausea (named in the label)5,893
  • Fatigue5,613
  • Vomiting5,449
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)5,176
  • Headache (named in the label)5,139
  • Sepsis4,708
  • Rash4,700
  • Arthralgia4,542
  • Malaise (named in the label)4,482
  • Pain4,296
  • Anaemia4,131
  • Death (an outcome recorded in the report)3,889
  • Infection (named in the label)3,637
  • Dizziness3,628
  • Neutropenia3,526
  • Abdominal Pain3,504
  • Treatment Failure (a use or a product term, not a reaction)3,480
  • General Physical Health Deterioration3,398

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

What next?

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