Overview
Prednisolone is a glucocorticoid similar to cortisol used for its anti-inflammatory, immunosuppressive, anti-neoplastic, and vasoconstrictive effects. Prednisolone was granted FDA approval on 21 June 1955.
Background
Prednisolone is a glucocorticoid similar to cortisol used for its anti-inflammatory, immunosuppressive, anti-neoplastic, and vasoconstrictive effects. Prednisolone was granted FDA approval on 21 June 1955.
Indication
Prednisolone is indicated to treat endocrine, rheumatic, and hematologic disorders; collagen, dermatologic, ophthalmic, respiratory, and gastrointestinal diseases; allergic and edematous states; and other conditions like tuberculous meningitis.
Associated Conditions
- Acute Gouty Arthritis
- Acute Leukemia
- Allergic Bronchopulmonary Aspergillosis
- Allergic Conjunctivitis (AC)
- Allergic Contact Dermatitis
- Allergic Skin Reaction
- Allergic corneal marginal ulcers
- Alveolitis, Extrinsic Allergic
- Ankylosing Spondylitis (AS)
- Aspiration Pneumonia
- Aspiration Pneumonitis
- Atopic Dermatitis
- Bell's Palsy
- Berylliosis
- Bullous dermatitis herpetiformis
- Burns
- Chorioretinitis
- Choroiditis
- Congenital Adrenal Hyperplasia (CAH)
- Congenital Hypoplastic Anemia
- Conjunctivitis
- Contact Dermatitis
- Corneal injuries
- Corneal ulceration
- Crohn's Disease (CD)
- Cyclitis
- Dermatomyositis (DM)
- Dermatosis of the Ear Canal
- Drug hypersensitivity reaction
- Edema of the cerebrum
- Epicondylitis
- Erythroblastopenia
- Exacerbation of COPD
- Exacerbation of asthma
- Eye inflammation caused by Cataract Surgery
- Eye inflammation caused by Infection
- Fissure;Anal
- Herpes Zoster Keratitis
- Hot Water Burns (Scalds)
- Hypercalcemia of Malignancy
- Idiopathic Pulmonary Fibrosis (IPF)
- Immune Thrombocytopenia (ITP)
- Inflamed External Hemorrhoid
- Inflamed Hemorrhoids, Internal
- Inflammatory Reaction caused by susceptible Bacterial Infections
- Iridocyclitis
- Iritis
- Itching caused by susceptible Bacterial Infections
- Keratitis
- Loeffler's syndrome
- Lymphoma
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Multiple sclerosis exacerbation
- Mycosis Fungoides (MF)
- Ocular Inflammation
- Ophthalmia, Sympathetic
- Optic Neuritis
- Otic Eczema
- Pemphigus
- Perennial Allergic Rhinitis (PAR)
- Pericarditis
- Pneumocystis Jirovecii Pneumonia
- Polymyalgia Rheumatica (PMR)
- Posterior Uveitis
- Posttraumatic Osteoarthritis
- Proctitis
- Proteinuria
- Pruritus
- Pruritus Ani
- Psoriatic Arthritis
- Pulmonary Tuberculosis (TB)
- Pure Red Cell Aplasia
- Rash
- Relapsing Polychondritis
- Rheumatoid Arthritis
- Rheumatoid Arthritis, Juvenile
- Rosacea
- Seasonal Allergic Rhinitis
- Secondary Adrenal Insufficiency
- Secondary thrombocytopenia
- Serum Sickness
- Severe Asthma
- Sjogren's Syndrome (SS)
- Stevens-Johnson Syndrome
- Superficial punctate keratitis
- Synovitis
- Systemic Lupus Erythematosus
- Transplanted Organ Rejection
- Trichinosis
- Tuberculosis (TB)
- Tuberculous Meningitis
- Ulcerative Colitis
- Uveitis
- Vasculitis
- Acquired immune hemolytic anemia
- Acute Bursitis
- Acute Rheumatic heart disease, unspecified
- Acute Tenosynovitis
- Anal eczema
- Bacterial skin infections
- Exfoliative erythroderma
- Idiopathic Bronchiolitis obliterans with organizing pneumonia
- Idiopathic eosinophilic pneumonias
- Non-suppurative Thyroiditis
- Primary adrenocoritical insufficiency
- Severe Psoriasis
- Severe Seborrhoeic dermatitis
- Severe alcoholic liver disease
- Steroid-responsive inflammation of the eye
- Subacute Bursitis
- Susceptible Bacterial Infections
- Symptomatic Sarcoidosis
- Varicella-zoster virus acute retinal necrosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/25 | Phase 1 | Not yet recruiting | |||
2025/06/05 | Phase 2 | Not yet recruiting | |||
2025/05/04 | Phase 3 | Not yet recruiting | University Hospital, Lille | ||
2025/05/01 | Phase 2 | Not yet recruiting | |||
2025/04/24 | Phase 4 | Not yet recruiting | |||
2025/04/09 | Phase 3 | Recruiting | Asian Institute of Gastroenterology, India | ||
2025/04/08 | Not Applicable | Completed | Hotel Dieu de France Hospital | ||
2025/03/24 | Phase 2 | Recruiting | |||
2025/02/11 | Phase 2 | Recruiting | |||
2024/12/05 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aidarex Pharmaceuticals LLC | 33261-475 | ORAL | 15 mg in 5 mL | 1/23/2014 | |
| Royal Pharmaceuticals | 68791-104 | ORAL | 5 mg in 5 mL | 2/13/2018 | |
| Edenbridge Pharmaceuticals LLC. | 42799-815 | ORAL | 15 mg in 5 mL | 12/4/2023 | |
| Edenbridge Pharmaceuticals LLC. | 42799-816 | ORAL | 25 mg in 5 mL | 12/4/2023 | |
| Stat Rx USA | 16590-291 | ORAL | 15 mg in 5 mL | 10/27/2009 | |
| A-S Medication Solutions | 50090-1582 | ORAL | 15 mg in 5 mL | 6/14/2023 | |
| Advanz Pharma (US) Corp. | 59212-700 | ORAL | 10 mg in 1 1 | 6/3/2025 | |
| Concordia Pharmaceuticals Inc. | 59212-700 | ORAL | 10 mg in 1 1 | 6/3/2025 | |
| Physicians Total Care, Inc. | 54868-4748 | ORAL | 5 mg in 5 mL | 1/5/2010 | |
| Proficient Rx LP | 63187-215 | ORAL | 15 mg in 5 mL | 1/1/2021 |
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 |
|---|---|---|---|---|---|
| PREDNISOLONE TABLET 5 mg | ATLANTIC LABORATORIES CORPN LTD | SIN04726P | TABLET | 5 mg | 6/26/1990 |
| PREDNISOLONE TABLET 20 mg | SIN07628P | TABLET | 20 mg | 2/1/1994 | |
| DHASOLONE TABLET 5 mg | SIN04207P | TABLET | 5 mg | 4/16/1990 | |
| PRELONE SYRUP 3 mg/5 ml | SIN04845P | SYRUP | 3 mg/5 ml | 6/29/1990 | |
| PREDNISOLONE TABLET 1 mg | SIN05149P | TABLET | 1 mg | 10/16/1990 | |
| WALESOLONE SYRUP 10 mg/5 ml | SUNWARD PHARMACEUTICAL PRIVATE LIMITED | SIN07848P | SYRUP | 10 mg/5 ml | 9/17/1994 |
| PREDNISOLONE TABLET 5 mg | SIN04237P | TABLET | 5 mg | 4/12/1990 | |
| XEPASONE TABLET 5 mg | SIN04190P | TABLET | 5 mg | 4/17/1990 | |
| YSP PREDNISOLONE TABLET 5 mg | SIN07771P | TABLET | 5 mg | 7/9/1994 | |
| DELTASOLONE TABLET 5 mg | SIN04187P | TABLET | 5 mg | 4/17/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Prednisolone Acetate Eye Drops | 国药准字HJ20171243 | 化学药品 | 眼用制剂 | 11/4/2022 | |
| Prednisolone Acetate Eye Drops | 国药准字HJ20171244 | 化学药品 | 眼用制剂 | 11/4/2022 | |
| Prednisolone Acetate Injection | 国药准字H20023134 | 化学药品 | 注射剂 | 4/26/2020 | |
| Prednisolone Acetate Injection | 国药准字H31021289 | 化学药品 | 注射剂 | 5/14/2020 | |
| Prednisolone Acetate Injection | 国药准字H33021520 | 化学药品 | 注射剂 | 4/26/2020 | |
| Prednisolone Acetate Injection | 国药准字H32022728 | 化学药品 | 注射剂 | 11/26/2020 | |
| Prednisolone Acetate Injection | 国药准字H37022910 | 化学药品 | 注射剂 | 8/30/2023 | |
| Prednisolone Acetate Injection | 国药准字H33020824 | 化学药品 | 注射剂 | 4/26/2020 | |
| Prednisolone Acetate Injection | 国药准字H42021216 | 化学药品 | 注射剂 | 9/7/2020 | |
| Prednisolone Tablets | 国药准字H11022552 | 化学药品 | 片剂 | 9/27/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PREDNISOLONE TAB 5MG | N/A | jean-marie pharmacal co ltd | N/A | N/A | 2/29/1980 |
| PREDNISOLONE TAB 5MG | N/A | N/A | N/A | 12/24/2010 | |
| XEPASONE TAB 5MG | N/A | N/A | N/A | 9/16/1988 | |
| PREDNISOLONE TAB 5MG | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 4/27/1979 |
| PREDNISOLONE TAB 5MG | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 3/18/1992 |
| PREDNISOLONE SUSP 10MG/5ML (VIDA) | N/A | N/A | N/A | 3/1/1999 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PREDMIX prednisolone (as sodium phosphate) 5mg/1mL liquid bottle | 67496 | Medicine | A | 1/19/1999 | |
| Panafcortelone 5 mg Tablets bottle | 27962 | Medicine | A | 10/21/1991 | |
| ASPEN Prednisolone 25mg/5mL (as sodium phosphate) oral liquid bottle | 376591 | Medicine | A | 2/3/2022 | |
| PREDSOL prednisolone 5mg (as sodium phosphate) suppository blister pack | 56510 | Medicine | A | 9/17/1996 | |
| REDIPRED prednisolone 25mg/5mL (as sodium phosphate) oral liquid bottle | 62506 | Medicine | A | 3/11/1998 | |
| SOLONE prednisolone 25 mg tablet bottle | 13468 | Medicine | A | 8/30/1991 | |
| Panafcortelone 1mg tablet bottle | 27960 | Medicine | A | 10/21/1991 | |
| MINIMS PREDNISOLONE SODIUM PHOSPHATE 0.5% 5mg/mL eye drops ampoule | 32233 | Medicine | A | 10/30/1991 | |
| Panafcortelone 25 mg Tablets bottle | 27964 | Medicine | A | 10/21/1991 | |
| PREDSOL Retention Enema | 12518 | Medicine | A | 8/13/1991 |