Overview
A synthetic anti-inflammatory glucocorticoid derived from cortisone. It is biologically inert and converted to prednisolone in the liver. Prednisone was granted FDA approval on 21 February 1955.
Indication
Prednisone is indicated as an anti-inflammatory or immunosuppressive drug for allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, infectious, endocrine, or neoplastic conditions as well as in organ transplant.
Associated Conditions
- Acne Vulgaris
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- Acute Gouty Arthritis
- Acute Leukemia
- Aggressive Lymphoma
- Allergic Bronchopulmonary Aspergillosis
- Allergic Conjunctivitis (AC)
- Allergic Rhinitis (AR)
- Allergic corneal marginal ulcers
- Alveolitis, Extrinsic Allergic
- Ankylosing Spondylitis (AS)
- Aspiration Pneumonitis
- Asthma
- Atopic Dermatitis
- Autoimmune Hepatitis
- Bell's Palsy
- Berylliosis
- Bullous dermatitis herpetiformis
- Chorioretinitis
- Congenital Adrenal Hyperplasia (CAH)
- Congenital Hypoplastic Anemia
- Contact Dermatitis
- Disseminated tuberculosis
- Drug hypersensitivity reaction
- Edema of the cerebrum
- Epicondylitis
- Erythroblastopenia
- Giant Cell Arteritis (GCA)
- Hypercalcemia of Malignancy
- Idiopathic Pulmonary Fibrosis (IPF)
- Immune Thrombocytopenia (ITP)
- Iridocyclitis
- Iritis
- Keratitis
- Leukemias
- Loeffler's syndrome
- Lymphoma
- Meningitis caused by Mycobacterium Tuberculosis
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Mycosis Fungoides (MF)
- Ocular Inflammation
- Ophthalmia, Sympathetic
- Optic Neuritis
- Pain caused by Herpes zoster
- Pemphigus
- Pericarditis
- Pneumocystis Jirovecii Pneumonia
- Polymyalgia Rheumatica (PMR)
- Polymyositis
- Posterior Uveitis
- Primary adrenocortical insufficiency
- Psoriatic Arthritis
- Pure Red Cell Aplasia
- Regional Enteritis
- Relapsing Polychondritis
- Rheumatoid Arthritis
- Rheumatoid Arthritis, Juvenile
- Secondary adrenocortical insufficiency
- Secondary thrombocytopenia
- Serum Sickness
- Severe Seborrheic Dermatitis
- Sjogren's Syndrome (SS)
- Solid Organ Transplant Rejection
- Stevens-Johnson Syndrome
- Systemic Lupus Erythematosus
- Takayasu Arteritis
- Thyroid Eye Disease
- Thyroiditis
- Thyrotoxicosis
- Trichinosis
- Ulcerative Colitis
- Uveitis
- Vasculitis
- Acquired immune hemolytic anemia
- Acute Bursitis
- Acute Crohn's Disease (CD)
- Acute Multiple sclerosis exacerbation
- Acute rheumatic carditis
- Anterior eye segment inflammation
- Exfoliative erythroderma
- Fulminating Tuberculosis
- Idiopathic Bronchiolitis obliterans with organizing pneumonia
- Idiopathic eosinophilic pneumonias
- Non-suppurative Thyroiditis
- Severe Psoriasis
- Subacute Bursitis
- Symptomatic Sarcoidosis
- Synovitis of osteoarthritis
- Systemic Dermatomyositis
- Varicella-zoster virus acute retinal necrosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/24 | Phase 2 | Not yet recruiting | |||
2025/06/05 | Phase 2 | Not yet recruiting | |||
2025/05/21 | Phase 3 | Not yet recruiting | |||
2025/05/18 | Phase 1 | Recruiting | |||
2025/05/02 | Phase 2 | Recruiting | Jennifer Amengual | ||
2025/04/18 | Early Phase 1 | Not yet recruiting | Christopher John McDougle, M.D. | ||
2025/04/13 | Phase 3 | Recruiting | |||
2025/04/01 | Phase 2 | Recruiting | Hospital Universitario Dr. Jose E. Gonzalez | ||
2025/03/24 | Phase 2 | Recruiting | |||
2025/03/05 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-0439 | ORAL | 5 mg in 1 1 | 8/19/2022 | |
| ANI Pharmaceuticals, Inc. | 70954-061 | ORAL | 50 mg in 1 1 | 2/16/2024 | |
| QPharma Inc | 42708-045 | ORAL | 10 mg in 1 1 | 12/8/2023 | |
| NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8391 | ORAL | 10 mg in 1 1 | 8/2/2022 | |
| Northwind Pharmaceuticals | 51655-763 | ORAL | 2.5 mg in 1 1 | 1/1/2023 | |
| A-S Medication Solutions | 50090-1455 | ORAL | 2.5 mg in 1 1 | 1/5/2023 | |
| Diect_Rx | 61919-326 | ORAL | 20 mg in 1 1 | 8/7/2019 | |
| A-S Medication Solutions | 50090-4784 | ORAL | 20 mg in 1 1 | 4/30/2019 | |
| RedPharm Drug, Inc. | 67296-1767 | ORAL | 10 mg in 1 1 | 1/21/2022 | |
| RPK Pharmaceuticals, Inc. | 53002-3090 | ORAL | 10 mg in 1 1 | 12/7/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| APO-PREDNISONE TABLET 5 mg | SIN04379P | TABLET | 5 mg | 5/3/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Prednisone Tablets | 国药准字H20203399 | 化学药品 | 片剂 | 8/5/2020 | |
| Prednisone Tablets | 国药准字H20237051 | 化学药品 | 片剂 | 5/11/2023 | |
| Prednisone Tablets | 国药准字H20203400 | 化学药品 | 片剂 | 8/5/2020 | |
| Prednisone Tablets | 国药准字H20203398 | 化学药品 | 片剂 | 8/5/2020 | |
| Prednisone Tablets | 国药准字H20237052 | 化学药品 | 片剂 | 5/11/2023 | |
| Prednisone Tablets | 国药准字H20237053 | 化学药品 | 片剂 | 5/11/2023 | |
| Prednisone Acetate Tablets | 国药准字H41020214 | 化学药品 | 片剂 | 2/24/2020 | |
| Prednisone Acetate Tablets | 国药准字H23021650 | 化学药品 | 片剂 | 6/8/2020 | |
| Prednisone Acetate Tablets | 国药准字H44020361 | 化学药品 | 片剂 | 1/25/2021 | |
| Prednisone Acetate Tablets | 国药准字H41021489 | 化学药品 | 片剂 | 8/14/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PREDSONE prednisone 1 mg tablet bottle | 99792 | Medicine | A | 2/23/2004 | |
| PANAFCORT prednisone 1 mg tablet bottle | 39879 | Medicine | A | 5/26/1992 | |
| SONE prednisone 25 mg tablet bottle | 13470 | Medicine | A | 8/30/1991 | |
| predniSONE Tablet 20mg | 400512 | Medicine | A | 12/4/2022 | |
| PANAFCORT prednisone 25 mg tablet bottle | 27957 | Medicine | A | 10/21/1991 | |
| predniSONE Tablet 10mg | 400511 | Medicine | A | 12/4/2022 | |
| PANAFCORT prednisone 5 mg tablet bottle | 27974 | Medicine | A | 10/21/1991 | |
| SONE prednisone 5 mg tablet bottle | 56129 | Medicine | A | 7/4/1996 | |
| predniSONE Tablet, 5mg | 400510 | Medicine | A | 12/4/2022 |
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