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

Research Report

Published: Jul 16, 2025

Comprehensive Monograph on Prednisone (DB00635)

[Executive Summary]

Prednisone is a potent, synthetically produced glucocorticoid that has served as a cornerstone of anti-inflammatory and immunosuppressive therapy for over half a century, following its initial FDA approval on February 21, 1955.[1] It functions as a biologically inert prodrug, requiring hepatic conversion to its active metabolite, prednisolone, to exert its therapeutic effects.[1] Its mechanism of action is profound and ubiquitous, involving the binding to glucocorticoid receptors present in nearly every cell type in the body.[3] This interaction leads to complex downstream effects on gene expression, primarily the suppression of pro-inflammatory pathways and the enhancement of anti-inflammatory processes. This broad mechanism underpins Prednisone's remarkable efficacy across an extensive spectrum of clinical conditions, including rheumatologic, respiratory, allergic, hematologic, neoplastic, and autoimmune diseases, as well as in the prevention of organ transplant rejection.[1]

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma	2025/08/15	NCT07124936	Not Applicable	Recruiting	Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment of Aggressive B-Cell Non-Hodgkin Lymphoma	2025/07/31	NCT07097363	Not Applicable	Not yet recruiting	University of Washington
Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)	2025/07/18	NCT07072585	Not Applicable	Not yet recruiting	Children's Oncology Group
Evaluation of Oral Corticosteroid Therapy in Idiopathic Sudden Unilateral Hearing Loss.	2025/07/16	NCT07067801	Not Applicable	Not yet recruiting	Centre Hospitalier Universitaire de Besancon
Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial	2025/07/11	NCT07060638	Not Applicable	Not yet recruiting	Samer Gawrieh
A Phase II Trial of 4 vs 6 Cycles of CHP Combined With Polatuzumab Vedotin-Rituximab in Untreated DLBCL Patients With IPI 0-1	2025/06/24	NCT07034508	Phase 2	Not yet recruiting	Institute of Hematology & Blood Diseases Hospital, China
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer	2025/06/05	NCT07005154	Phase 2	Recruiting	Astellas Pharma Global Development, Inc.
Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW)	2025/05/21	NCT06983821	Phase 3	Not yet recruiting	Ottawa Hospital Research Institute
Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)	2025/05/18	NCT06977711	Phase 1	Recruiting	The University of Texas Health Science Center at San Antonio
Defining ctDNA Metrics in Posttransplant Lymphoproliferative Disorder (PTLD)	2025/05/02	NCT06954805	Phase 2	Recruiting	Jennifer Amengual

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Prednisone	A-S Medication Solutions	50090-0439	ORAL	5 mg in 1 1	8/19/2022
Prednisone	ANI Pharmaceuticals, Inc.	70954-061	ORAL	50 mg in 1 1	2/16/2024
PredniSONE	QPharma Inc	42708-045	ORAL	10 mg in 1 1	12/8/2023
PredniSONE	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8391	ORAL	10 mg in 1 1	8/2/2022
PredniSONE	Northwind Pharmaceuticals	51655-763	ORAL	2.5 mg in 1 1	1/1/2023
PredniSONE	A-S Medication Solutions	50090-1455	ORAL	2.5 mg in 1 1	1/5/2023
PREDNISONE	Diect_Rx	61919-326	ORAL	20 mg in 1 1	8/7/2019
PREDNISONE	A-S Medication Solutions	50090-4784	ORAL	20 mg in 1 1	4/30/2019
PREDNISONE	RedPharm Drug, Inc.	67296-1767	ORAL	10 mg in 1 1	1/21/2022
Prednisone	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	APOTEX INC	SIN04379P	TABLET	5 mg	5/3/1990

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

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	Aspen Pharmacare Australia Pty Ltd	Medicine	A	2/23/2004
PANAFCORT prednisone 1 mg tablet bottle	39879	Aspen Pharmacare Australia Pty Ltd	Medicine	A	5/26/1992
SONE prednisone 25 mg tablet bottle	13470	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	8/30/1991
predniSONE Tablet 20mg	400512	Alphapharm Pty Ltd	Medicine	A	12/4/2022
PANAFCORT prednisone 25 mg tablet bottle	27957	Aspen Pharmacare Australia Pty Ltd	Medicine	A	10/21/1991
predniSONE Tablet 10mg	400511	Alphapharm Pty Ltd	Medicine	A	12/4/2022
PANAFCORT prednisone 5 mg tablet bottle	27974	Aspen Pharmacare Australia Pty Ltd	Medicine	A	10/21/1991
SONE prednisone 5 mg tablet bottle	56129	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	7/4/1996
predniSONE Tablet, 5mg	400510	Alphapharm Pty Ltd	Medicine	A	12/4/2022

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PREDNISONE 50 TAB 50MG	PRO DOC LIMITEE	00607517	Tablet - Oral	50 MG	12/31/1994
NU-PREDNISONE	nu-pharm inc	02239539	Tablet - Oral	1 MG	N/A
TEVA-PREDNISONE	teva canada limited	00232378	Tablet - Oral	50 MG	12/31/1972
APO PREDNISONE TAB 1MG USP	Apotex Inc	00598194	Tablet - Oral	1 MG	12/31/1984
DELTASONE 5MG	pharmacia & upjohn inc	00210188	Tablet - Oral	5 MG / TAB	12/31/1972
NU-PREDNISONE	nu-pharm inc	02239541	Tablet - Oral	50 MG	N/A
METRETON TAB	schering-plough canada inc	00177091	Tablet - Oral	2.5 MG	12/31/1956
JAA PREDNISONE TAB 5MG USP	jaapharm canada inc.	00868442	Tablet - Oral	5 MG	12/31/1993
WINPRED TAB 5MG	valeant canada lp / valeant canada s.e.c.	00271381	Tablet - Oral	5 MG	12/31/1985
JAA PREDNISONE TAB 1MG USP	jaapharm canada inc.	00868426	Tablet - Oral	1.0 MG	5/15/1993

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
PREDNISONA TARBIS 30 mg COMPRIMIDOS EFG	Tarbis Farma S.L.	75677	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
PREDNISONA TARBIS 10 mg COMPRIMIDOS	Tarbis Farma S.L.	75641	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
PREDNISONA CINFA 5 mg COMPRIMIDOS EFG	Laboratorios Cinfa S.A.	75647	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
PREDNISONA CINFA 30 mg COMPRIMIDOS EFG	Laboratorios Cinfa S.A.	75676	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
PREDNISONA CINFA 2,5 mg COMPRIMIDOS EFG	Laboratorios Cinfa S.A.	75644	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
DACORTIN 2,5 mg COMPRIMIDOS	Laboratorios Ern S.A.	47863	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
PREDNISONA KERN PHARMA 30 mg COMPRIMIDOS EFG	Kern Pharma S.L.	70108	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
PREDNISONA ALONGA 50 mg COMPRIMIDOS	Cheplapharm Arzneimittel Gmbh	58336	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Not Commercialized
PREDNISONA TARBIS 2,5 mg COMPRIMIDOS EFG	Tarbis Farma S.L.	75634	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
PREDNISONA KERN PHARMA 5 mg COMPRIMIDOS EFG	Kern Pharma S.L.	70106	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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