Prednisone Side Effects: Common, Serious & FDA Warnings
Based on 491,000+ FDA adverse event reports, the most-reported prednisone reactions include fatigue, pain, and dyspnoea. No active recalls are on record. The FDA-approved label does not carry a boxed warning.
Common Side Effects of Prednisone
The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for prednisone. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.
| Reaction | Reports | % of total |
|---|---|---|
| Fatigue | 40,183 | 8.2% |
| Pain | 37,384 | 7.6% |
| Dyspnoea | 34,348 | 7.0% |
| Arthralgia | 32,793 | 6.7% |
| Condition Aggravated | 28,169 | 5.7% |
| Diarrhoea | 27,961 | 5.7% |
| Nausea | 28,099 | 5.7% |
| Headache | 26,179 | 5.3% |
| Pneumonia | 24,585 | 5.0% |
| Rheumatoid Arthritis | 24,642 | 5.0% |
Serious Outcomes and FDA Warnings
FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.
| Outcome flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
Prednisone Recalls
FDA enforcement actions matched to prednisone via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.
No recalls are on record for this drug in the FDA enforcement database.
Show 4 closed recalls (2013 to 2022)
Includes resolved and terminated recalls matched to prednisone. Most recent first.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2022-08-17 | Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets Strides Pharma Inc. | Class II | 1032 bottles | Terminated |
| 2020-03-25 | Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg Par Pharmaceutical Inc. | Class III | 13008 bottles | Terminated |
| 2016-10-12 | Failed Tablet/Capsule Specifications: Discovery of an underweight tablet. West-Ward Pharmaceutical | Class II | 15,109 bottles | Terminated |
| 2013-08-21 | Labeling: Missing Label; missing label on blister card Boehringer Ingelheim Roxane Inc | Class III | 14,619 cartons | Terminated |
Prednisone Shortages
FDA-listed shortages of prednisone products. Strength and dosage-form level detail.
Is Prednisone Safe?
Prednisone is FDA-approved and the label does not carry a boxed warning.
As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.
FDA-Approved Indications
Prednisone is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.
INDICATIONS Prednisone tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Hypercalcemia associated with cancer Nonsuppurative thyroiditis 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3.Show full Indications and Usage
Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis 7. Respiratory Diseases Symptomatic sarcoidosis Loeffler’s syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12. Nervous System Acute exacerbations of multiple sclerosis 13. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement
Frequently Asked Questions
What are the most-reported side effects of prednisone?
Is prednisone the same as Prednisone Delayed Release?
Has prednisone been recalled?
What do FDA recall classes mean?
Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here. | 6 hours |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-mapped from drug_labels.indications. Methodology at /methodology/. | Per-drug |
What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.