FDA label
What is prednisone used for?
The FDA-approved uses of prednisone, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for prednisone (solution) lists 12 uses: Endocrine Disorders; Rheumatic Disorders; Collagen Diseases; Dermatologic Diseases; and 8 more.
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Prednisone, tablet
Indications and Usage, quoted from the label by Strides Pharma Science Limited (ANDA210785). Cross-references to other label sections are left out.
Prednisone tablets USP are indicated in the following conditions:
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, nonsuppurative thyroiditis, hypercalcemia associated with cancer.
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; posttraumatic osteoarthritis; synovitis of osteoarthritis; epicondylitis.
Collagen Diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, acute rheumatic carditis.
Dermatologic Diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis.
Allergic States: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, serum sickness, bronchial asthma, contact dermatitis, atopic dermatitis, drug hypersensitivity reactions.
Ophthalmic Diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia.
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.
Hematologic Disorders: idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia.
Neoplastic Diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.
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.
Gastrointestinal Diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis.
Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.
In addition to the above indications, prednisone tablets are indicated for systemic dermatomyositis (polymyositis).
Source: DailyMed label, set id a2c2e8ee-d222-47c5-93c2-8b44160a7e48, version 10, effective December 3, 2025. NDC 64380-782, one of 310 listings for this product.
Prednisone, tablet, delayed release
Indications and Usage, quoted from the label by Dr. Reddys Laboratories Inc. (ANDA219477). Cross-references to other label sections are left out.
Prednisone delayed-release tablets are indicated in the treatment of the following diseases or conditions:
1.1 Allergic Conditions
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adults and pediatric populations with:
- Atopic dermatitis
- Drug hypersensitivity reactions
- Seasonal or perennial allergic rhinitis
- Serum sickness
1.2 Dermatologic Diseases
- Bullous dermatitis herpetiformis
- Contact dermatitis
- Exfoliative erythroderma
- Mycosis fungoides
- Pemphigus
- Severe erythema multiforme (Stevens-Johnson syndrome)
1.3 Endocrine Conditions
- Congenital adrenal hyperplasia
- Hypercalcemia of malignancy
- Nonsuppurative thyroiditis
- Primary or secondary adrenocortical insufficiency: hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable
1.4 Gastrointestinal Diseases
During acute episodes in:
- Crohn's Disease
- Ulcerative colitis
1.5 Hematologic Diseases
- Acquired (autoimmune) hemolytic anemia
- Diamond-Blackfan anemia
- Idiopathic thrombocytopenic purpura in adults
- Pure red cell aplasia
- Secondary thrombocytopenia in adults
1.6 Neoplastic Conditions
For the treatment of:
- Acute leukemia
- Aggressive lymphomas
1.7 Nervous System Conditions
- Acute exacerbations of multiple sclerosis
- Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury
1.8 Ophthalmic Conditions
- Sympathetic ophthalmia
- Uveitis and ocular inflammatory conditions unresponsive to topical steroids
1.9 Conditions Related to Organ Transplantation
- Acute or chronic solid organ rejection
1.10 Pulmonary Diseases
- Acute exacerbations of chronic obstructive pulmonary disease (COPD)
- Allergic bronchopulmonary aspergillosis
- Aspiration pneumonitis
- Asthma
- Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy
- Hypersensitivity pneumonitis
- Idiopathic bronchiolitis obliterans with organizing pneumonia
- Idiopathic eosinophilic pneumonias
- Idiopathic pulmonary fibrosis
- Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV(+) individual who is also under treatment with appropriate anti-PCP antibiotics.
- Symptomatic sarcoidosis
1.11 Renal Conditions
- To induce a diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus
1.12 Rheumatologic Conditions
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
- Acute gouty arthritis
During an exacerbation or as maintenance therapy in selected cases of:
- Ankylosing spondylitis
- Dermatomyositis/polymyositis
- Polymyalgia rheumatica
- Psoriatic arthritis
- Relapsing polychondritis
- Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy)
- Sjogren's syndrome
- Systemic lupus erythematosus
- Vasculitis
1.13 Specific Infectious Diseases
- Trichinosis with neurologic or myocardial involvement.
- Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy.
Source: DailyMed label, set id 01bdc479-1f1f-af94-837c-12e7e861321a, version 5, effective September 23, 2026. NDC 43598-886, one of 5 listings for this product.
Prednisone, solution
Indications and Usage, quoted from the label by Atlantic Biologicals Corps (ANDA088703). Cross-references to other label sections are left out.
Prednisone tablets and solutions are indicated in the following conditions:
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.
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.
Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis.
Dermatologic Diseases
Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis.
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.
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.
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.
Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia.
Neoplastic Diseases
For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.
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.
Gastrointestinal Diseases
To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis.
Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.
Source: DailyMed label, set id 07be390e-ef1e-4bf9-a9da-4338b5f6cfa5, version 8, effective September 29, 2026. NDC 17856-3722, one of 2 listings for this product.
Questions
What is prednisone used for?
The FDA label for prednisone (solution) lists 12 uses: Endocrine Disorders; Rheumatic Disorders; Collagen Diseases; Dermatologic Diseases; and 8 more.
What drug class is prednisone?
FDA lists prednisone in the Corticosteroid established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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