Prednisolone
Blephamide, Cetapred, Chloroptic-p, Hydeltra-tba, Metimyd, Neo-delta-cortef, Neo-hydeltrasol, Pred, Prednisolone, Prelone, Sulphrin, Vasocidin (prednisolone) is a small molecule pharmaceutical. Prednisolone was first approved as Chloroptic-p s.o.p. on 1982-01-01. It is used to treat adrenal insufficiency, ankylosing spondylitis, asthma, atopic dermatitis, and berylliosis amongst others in the USA. The pharmaceutical is active against glucocorticoid receptor. In addition, it is known to target mineralocorticoid receptor and nuclear receptor subfamily 1 group I member 2.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Omnipred, Orapred, Pediapred, Pred, Pred mild, Prednisolone, Prelone (discontinued: Cortalone, Delta-cortef, Econopred, Fernisolone-p, Flo-pred, Hydeltrasol, Inflamase, Meti-derm, Meticortelone, Metreton, Orapred, Prednisolone, Prelone, Sterane)
CombinationsSulfacetamide prednisolone (discontinued: Blephamide, Cetapred, Chloroptic-p, Isopto cetapred, Metimyd, Neo-delta-cortef, Neo-hydeltrasol, Poly-pred, Pred, Predamide, Sulfacetamide prednisolone, Sulphrin, Sulster, Vasocidin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Prednisolone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| STERANE | Pfizer | N-009996 DISCN | 1982-01-01 | 1 products |
| DELTA-CORTEF | Pharmacia & Upjohn | N-009987 DISCN | 1982-01-01 | 1 products |
| METI-DERM | Merck & Co | N-010209 DISCN | 1982-01-01 | 1 products |
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Prednisolone sodium phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ORAPRED ODT | ADVANZ PHARMA | N-021959 RX | 2006-06-01 | 3 products, RLD, RS |
| PEDIAPRED | Seton Pharmaceuticals | N-019157 RX | 1986-05-28 | 1 products, RLD, RS |
Show 2 discontinued
Prednisolone acetate
Prednisolone acetate
+
Sulfacetamide sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BLEPHAMIDE | Allergan | N-012813 DISCN | 1982-01-01 | 1 products, RLD |
| METIMYD | Merck & Co | N-010210 DISCN | 1982-01-01 | 2 products |
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Neomycin sulfate
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Prednisolone sodium phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NEO-HYDELTRASOL | Merck & Co | N-050378 DISCN | 1982-01-01 | 1 products |
Hide discontinued
Gentamicin sulfate
+
Prednisolone acetate
Prednisolone sodium phosphate
+
Sulfacetamide sodium
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| blephamide | New Drug Application | 2013-11-15 |
| cambison | unapproved drug other | 2018-12-06 |
| econopred | 2006-09-11 | |
| ixoba m | unapproved drug other | 2021-11-03 |
| orapred | New Drug Application | 2025-06-03 |
| pred forte | New Drug Application | 2024-02-29 |
| pred mild | New Drug Application | 2025-11-25 |
| pred phos - brom | unapproved drug other | 2018-06-08 |
| pred-brom | unapproved drug other | 2018-03-01 |
| pred-gati | unapproved drug other | 2018-02-22 |
Show 11 more
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PREDNISOLONE, PREDNISOLONE, AUROBINDO PHARMA LTD | |||
| 2023-11-18 | CGT | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Prednisolone Acetate, Flo-Pred, Taro | |||
| 7799331 | 2028-10-11 | DP | U-139, U-1068 |
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AC: Corticosteroids for local oral treatment
— A01AC54: Prednisolone, combinations
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07E: Intestinal antiinflammatory agents
— A07EA: Corticosteroids acting locally
— A07EA01: Prednisolone
C: Cardiovascular system drugs
— C05: Vasoprotectives
— C05A: Agents for treatment of hemorrhoids and anal fissures for topical use
— C05AA: Corticosteroids, topical for treatment of hemorrhoids and anal fissures
— C05AA04: Prednisolone
D: Dermatologicals
— D07: Corticosteroids, dermatological preparations
— D07A: Corticosteroid dermatological preparations, plain
— D07AA: Corticosteroids, weak (group i)
— D07AA03: Prednisolone
— D07B: Corticosteroids, combinations with antiseptics
— D07BA: Corticosteroids, weak, combinations with antiseptics
— D07BA01: Prednisolone and antiseptics
— D07C: Corticosteroids, combinations with antibiotics
— D07CA: Corticosteroids, weak, combinations with antibiotics
— D07CA03: Prednisolone and antibiotics
— D07X: Corticosteroids, other combinations
— D07XA: Corticosteroids, weak, other combinations
— D07XA02: Prednisolone
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H02: Corticosteroids for systemic use
— H02A: Corticosteroids for systemic use, plain
— H02AB: Glucocorticoids, systemic
— H02AB06: Prednisolone
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AD: Corticosteroid nasal preparations for topical use
— R01AD02: Prednisolone
— R01AD52: Prednisolone, combinations
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01B: Antiinflammatory agents, ophthalmologic
— S01BA: Corticosteroid ophthalmologic antiinflammatory agents, plain
— S01BA04: Prednisolone
— S01BB: Corticosteroids and mydriatics in combination
— S01BB02: Prednisolone and mydriatics
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CA: Corticosteroids and antiinfectives in combination, opthalmologic
— S01CA02: Prednisolone and antiinfectives
— S01CB: Corticosteroids/antiinfectives/mydriatics in combination
— S01CB02: Prednisolone
— S02: Otologicals
— S02B: Corticosteroid otologicals
— S02BA: Corticosteroids
— S02BA03: Prednisolone
— S02C: Corticosteroids and antiinfectives in combination, otologic
— S02CA: Corticosteroids and antiinfectives in combination
— S02CA01: Prednisolone and antiinfectives
— S03: Ophthalmological and otological preparations
— S03B: Corticosteroid ophthalmologic and otologic preparations
— S03BA: Corticosteroids
— S03BA02: Prednisolone
— S03C: Corticosteroids and antiinfectives in combination, opthalmologic and otologic
— S03CA: Corticosteroids and antiinfectives in combination
— S03CA02: Prednisolone and antiinfectives
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AB: Antidotes
— V03AB05: Prednisolone and promethazine
HCPCS
Code | Description |
|---|---|
| J1020 | Injection, methylprednisolone acetate, 20 mg |
| J1030 | Injection, methylprednisolone acetate, 40 mg |
| J1040 | Injection, methylprednisolone acetate, 80 mg |
| J2650 | Injection, prednisolone acetate, up to 1 ml |
| J2920 | Injection, methylprednisolone sodium succinate, up to 40 mg |
| J2930 | Injection, methylprednisolone sodium succinate, up to 125 mg |
| J7509 | Methylprednisolone oral, per 4 mg |
| J7510 | Prednisolone oral, per 5 mg |
Clinical
Clinical Trials
4212 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney transplantation | D016030 | — | — | — | — | 1 | 4 | — | 5 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 1 | 1 | 1 | 1 | 3 |
| Liver transplantation | D016031 | EFO_0010682 | — | — | — | 1 | 2 | — | 3 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | 1 | — | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | 1 | — | 2 |
| Healthy volunteers/patients | — | — | — | 1 | 1 | — | 1 | — | 2 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | 1 | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | 1 | — | 1 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | — | 1 | — | 1 |
| Renal replacement therapy | D017582 | — | — | — | — | — | 1 | — | 1 |
Show 15 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intermediate uveitis | D015867 | EFO_1000986 | — | — | — | 1 | — | — | 1 |
| Recurrence | D012008 | — | — | — | — | 1 | — | — | 1 |
| Follicular lymphoma | D008224 | — | C82 | — | — | 1 | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 1 | 3 | — | — | — | 3 |
| Giant cell arteritis | D013700 | EFO_1001209 | M31.6 | — | 2 | — | — | 1 | 3 |
| Polymyalgia rheumatica | D011111 | EFO_0008518 | M35.3 | — | 2 | — | — | 1 | 3 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 2 | 2 | — | — | — | 2 |
| Arteritis | D001167 | EFO_0009011 | I77.6 | — | 1 | — | — | 1 | 2 |
| Lymphoma | D008223 | — | C85.9 | — | 2 | — | — | — | 2 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | — | 2 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | — | 1 | — | — | — | 1 |
| Oral ulcer | D019226 | — | — | — | 1 | — | — | — | 1 |
Show 12 more
Indications Phases 1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Prednisolone |
| INN | prednisolone |
| Description | Prednisolone is a glucocorticoid that is prednisone in which the oxo group at position 11 has been reduced to the corresponding beta-hydroxy group. It is a drug metabolite of prednisone. It has a role as an adrenergic agent, an anti-inflammatory drug, an antineoplastic agent, an immunosuppressive agent, a drug metabolite, an environmental contaminant and a xenobiotic. It is a glucocorticoid, an 11beta-hydroxy steroid, a 21-hydroxy steroid, a 17alpha-hydroxy steroid, a 20-oxo steroid, a 3-oxo-Delta(1),Delta(4)-steroid, a primary alpha-hydroxy ketone, a tertiary alpha-hydroxy ketone and a C21-steroid. It is functionally related to a Delta(1)-progesterone. |
| Classification | Small molecule |
| Drug class | steroids (not prednisolone derivatives); prednisone and prednisolone derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@]12C[C@H](O)[C@H]3[C@@H](CCC4=CC(=O)C=C[C@@]43C)[C@@H]1CC[C@]2(O)C(=O)CO |
Identifiers
| PDB | — |
| CAS-ID | 50-24-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL131 |
| ChEBI ID | 8378 |
| PubChem CID | 5755 |
| DrugBank | DB00860 |
| UNII ID | 9PHQ9Y1OLM (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
NR3C2
NR3C2
Organism
Homo sapiens
Gene name
NR3C2
Gene synonyms
MCR, MLR
NCBI Gene ID
Protein name
mineralocorticoid receptor
Protein synonyms
aldosterone receptor, mineralocorticoid receptor 1, mineralocorticoid receptor 2, mineralocorticoid receptor delta, Nuclear receptor subfamily 3 group C member 2
Uniprot ID
Mouse ortholog
Nr3c2 (110784)
mineralocorticoid receptor (Q8VII8)
Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Prednisolone
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Gentamicin
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Prednisolone
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Neomycin
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Polymyxin b
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Prednisolone
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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172,956 adverse events reported
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