Prescription medicine

Prednisolone Brand names: Orapred, Pred; first approved as Meticortelone

Prednisolone (Pred) is a prescription medicine with an FDA approval on record since 1955. FDA's NDC Directory lists it from 25 generic labelers, and pharmacies paid $4.72 per mL (Prednisolone ac 1% eye drop) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $30.66 per mL (Pred mild 0.12% eye drops).

Generic listed

Check it at the source: the prednisolone FDA label on DailyMed (effective June 25, 2026, PAI Holdings, LLC dba PAI Pharma); the NDA 10255 record on Drugs@FDA; every prednisolone label on DailyMed.

Highlights of the record

FDA label of June 25, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
Prednisolone Sodium Phosphate Oral Solution is indicated in the following conditions: 1.

Forms and strengths

5 mg
10 mg
15 mg
30 mg
1.2 mg/ml
5 mg/5ml
10 mg/ml
10 mg/5ml
15 mg/5ml
20 mg/5ml
25 mg/5ml

Solution; suspension/ drops; orally disintegrating tablet; tablet; solution/ drops.

On the market

Earliest approval on file: May 22, 1955 Meticortelone, Schering; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 72 first November 24, 1971; 20 with a marketed status in Drugs@FDA
Labelers listed (NDC): 34 of which 25 under generic applications, 4 under brand applications, repackagers included
Last listed patent: October 11, 2028 Flo-Pred oral suspension; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $4.72 per mL Prednisolone ac 1% eye drop
Shortage (FDA): No current entry
Recalls by its makers (FDA): 9 since 2012 0 Class I among all firms' recalls; latest June 4, 2026; 5 more by firms not listed as its makers
FAERS reports: 191,407 through July 30, 2026

What is prednisolone used for?

From the label: indications and usage
Prednisolone Sodium Phosphate Oral Solution is indicated in the following conditions: 1. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. Dermatologic Diseases Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. […]

Conditions named in the indications of prednisolone's FDA labels, with every medicine labeled for each:

From other prednisolone labels
Anemia: Diamond-Blackfan anemia.
Leukemia, lymphoma and myeloma: Neoplastic Diseases For the treatment of acute leukemia and aggressive lymphomas in adults and children.
Multiple sclerosis: Nervous System Acute exacerbations of multiple sclerosis.
Osteoarthritis: … subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3.
Asthma and Allergies: Seasonal or perennial allergic rhinitis Serum sickness Bronchial asthma Contact dermatitis Atopic dermatitis Drug hypersensitivity reactions 6.
Herpes and shingles: 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 …

FDA pharmacologic class: Corticosteroid.

Source: FDA drug label (PrednisoLONE Sodium Phosphate), PAI Holdings, LLC dba PAI Pharma, effective June 25, 2026 (SPL set d1f937e7-fed5-4079-bd52-5d930b34ae9f), via openFDA; the full label on DailyMed

Is there a generic for prednisolone (Pred)?

The FDA approved the first generic prednisolone on November 24, 1971. 72 generic applications are approved; 20 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists prednisolone from 25 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists no patent for Pred Forte suspension/drops; a patent listed only for Flo-Pred oral suspension runs to October 11, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

1955 earliest approval on file
1971 first generic approved
2028 last listed patent
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for prednisolone (Pred)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $4.72 per mL (Prednisolone ac 1% eye drop), up 4% from $4.52 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Prednisolone ac 1% eye drop (generic)
Pred mild 0.12% eye drops (brand)

$30.79

$4.04

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Prednisolone 10 mg/5 mL solution	Generic	$2.43 per mL	n/a	-9%
Prednisolone 15 mg/5 mL solution	Generic	$0.568 per mL	n/a	-3%
Prednisolone 15 mg/5 mL syrup	Generic	$0.591 per mL	n/a	-5%
Prednisolone 5 mg tablet	Generic	$8.48 per tablet	$254.52	-7%
Prednisolone 5 mg/5 mL solution	Generic	$0.549 per mL	n/a	-1%
Prednisolone ac 1% eye drop	Generic	$4.72 per mL	n/a	+4%
Prednisolone sod 1% eye drop	Generic	$4.57 per mL	n/a	+6%
Pred forte 1% eye drops	Brand	$30.71 per mL	n/a	+0.1%
Pred mild 0.12% eye drops	Brand	$30.66 per mL	n/a	-0.3%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has prednisolone been recalled?

The FDA's Enforcement Report lists 14 recalls naming prednisolone since 2012: 0 Class I (the most serious), 11 Class II, 3 Class III; 4 still ongoing. 5 of them are by firms that FDA's NDC Directory does not list as a maker of prednisolone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
June 4, 2026	Class II	Lupin Pharmaceuticals Inc.	Presence of Foreign Substance
May 18, 2026	Class III	AbbVie Inc.	Failed Stability Specifications
April 26, 2023	Class II	Akorn, Inc. not a listed maker	CGMP Deviations: Firm went out of business and could no longer continue stability studies.
August 1, 2022	Class II	Akorn, Inc	Defective Container: Product has incomplete induction seals.
April 13, 2022	Class II	Mckesson Medical-Surgical Inc. Corporate Office	cGMP deviations: Temperature abuse
June 5, 2020	Class III	Akorn, Inc.	Discoloration: Out of Specification (OOS) result for APHA Color Test.
September 23, 2019	Class II	Morton Grove Pharmaceuticals, Inc.	Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
July 24, 2018	Class II	Morton Grove Pharmaceuticals, Inc.	Defective Container: Tamper Evident foil seal not completely intact.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the prednisolone label say about other medicines?

The prednisolone label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 29 other medicines name prednisolone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Amphotericin b	drug interactions	Potassium-depleting agents (e.g., diuretics, Amphotericin B): When corticosteroids are administered concomitantly with potassium-depleting agents, patients should be observed closely for development of hypokalemia.
Aspirin	drug interactions	Concomitant use of aspirin (or other non-steroidal anti-inflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects.
Carbamazepine	drug interactions	CYP 3A4 inducers (e.g. barbiturates, phenytoin, carbamazepine, and rifampin): Drugs such as barbiturates, phenytoin, ephedrine, and rifampin, which induce hepatic microsomal drug metabolizing enzyme activity may enhance metabolism of prednisolone and require that the dosage of Orapred be increased.
Cholestyramine	drug interactions	Cholestyramine: Cholestyramine may increase the clearance of corticosteroids.
Cortisone	warnings	Cardio-renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.
Cyclosporine	drug interactions	Cyclosporine: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently.
Ephedrine	drug interactions	Drug Interactions Drugs such as barbiturates, phenytoin, ephedrine, and rifampin, which induce hepatic microsomal drug metabolizing enzyme activity may enhance metabolism of prednisolone and require that the dosage of Prednisolone Sodium Phosphate Oral Solution be increased.
Hydrocortisone	warnings	Cardio-renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.
Isoniazid	drug interactions	Antitubercular drugs: Serum concentrations of isoniazid may be decreased.
Ketoconazole	drug interactions	Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60% leading to an increased risk of corticosteroid side effects.
Phenytoin	drug interactions	Drug Interactions Drugs such as barbiturates, phenytoin, ephedrine, and rifampin, which induce hepatic microsomal drug metabolizing enzyme activity may enhance metabolism of prednisolone and require that the dosage of Prednisolone Sodium Phosphate Oral Solution be increased.
Rifampin	drug interactions	Drug Interactions Drugs such as barbiturates, phenytoin, ephedrine, and rifampin, which induce hepatic microsomal drug metabolizing enzyme activity may enhance metabolism of prednisolone and require that the dosage of Prednisolone Sodium Phosphate Oral Solution be increased.
Warfarin	drug interactions	Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports.

Other labels that name prednisolone

Check prednisolone against other medicines

What do FAERS reports show for prednisolone?

The FDA Adverse Event Reporting System holds 191,407 reports that list prednisolone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 29,606 are coded as a death and 84,722 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Off Label Use (a use or a product term, not a reaction)16,339
Drug Ineffective (a use or a product term, not a reaction)13,824
Pyrexia8,820
Dyspnoea7,428
Pneumonia7,315
Diarrhoea7,102
Condition Aggravated (a use or a product term, not a reaction)6,364
Nausea (named in the label)5,893

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as prednisolone?

13 other medicines are given the same way (oral) and in the same FDA class as prednisolone or labeled mainly for the same use (anemia), the same class first. Anemia lists all 25 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (oral)	Pharmacy cost	Shortage
Prednisone	Osteoarthritis, Asthma, Allergies, Crohn's disease and ulcerative colitis, Herpes and shingles, Eczema (atopic dermatitis), Multiple sclerosis, Leukemia, lymphoma and myeloma, Anemia, Organ transplant rejection	46 labelers	$0.0643 per tablet 20 mg tablet	No current entry
Dexamethasone	Osteoarthritis, Asthma, Allergies, Crohn's disease and ulcerative colitis, Herpes and shingles, Eczema (atopic dermatitis), Leukemia, lymphoma and myeloma, Anemia	41 labelers	$0.193 per tablet 4 mg tablet	In shortage
Hydrocortisone	Osteoarthritis, Asthma, Allergies, Crohn's disease and ulcerative colitis, Herpes and shingles, Leukemia, lymphoma and myeloma	16 labelers	$0.180 per tablet 10 mg tablet	A presentation being discontinued
Methylprednisolone	Osteoarthritis, Allergies, Crohn's disease and ulcerative colitis, Herpes and shingles, Multiple sclerosis, Leukemia, lymphoma and myeloma, Anemia	24 labelers	$0.121 per tablet 4 mg tablet	In shortage
Budesonide	Asthma, Crohn's disease and ulcerative colitis	14 labelers	$0.498 per capsule 3 mg capsule	No current entry
Cortisone	Osteoarthritis, Asthma, Allergies, Crohn's disease and ulcerative colitis, Herpes and shingles, Leukemia, lymphoma and myeloma	1 labeler	n/a	No current entry
Lenalidomide	Leukemia, lymphoma and myeloma, Anemia	18 labelers	n/a	No current entry
Eltrombopag	Anemia	13 labelers	$25.85 per tablet 50 mg tablet	No current entry

Every medicine labeled for the same conditions as prednisolone

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does prednisolone compare with medicines for the same use?

15 side-by-side pages set prednisolone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to prednisolone: 13 medicines for the same use
Other corticosteroids: the pharmacologic class, with prices and generics
Prednisolone side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other