Prescription medicine

Cortisone First approved as Cortone

Cortisone (Cortone) is a prescription medicine with an FDA approval on record since 1950. FDA's NDC Directory lists it from 1 generic labeler.

Generic listed

Check it at the source: the cortisone FDA label on DailyMed (effective June 6, 2025, Chartwell RX, LLC); the NDA 7110 record on Drugs@FDA; every cortisone label on DailyMed.

Highlights of the record

FDA label of June 6, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
When oral therapy is not feasible: 1.

Forms and strengths

25 mg

Tablet.

On the market

Earliest approval on file: June 13, 1950 Cortone, Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 9 first January 3, 1972; 0 with a marketed status in Drugs@FDA
Labelers listed (NDC): 1 of which 1 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 12,274 through July 30, 2026

What is cortisone used for?

From the label: indications and usage
When oral therapy is not feasible: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. […]

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

From other cortisone labels
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 Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness 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 …
Leukemia, lymphoma and myeloma: Leukemias and lymphomas in adults Acute leukemia of childhood 10.
Crohn's disease and ulcerative colitis: Ulcerative colitis Regional enteritis 12.

FDA pharmacologic class: Corticosteroid.

Source: FDA drug label (Cortisone Acetate), Chartwell RX, LLC, effective June 6, 2025 (SPL set cc158d11-f356-4696-8b73-5d2681dcbcf2), via openFDA; the full label on DailyMed

Is there a generic for cortisone (Cortone)?

The FDA approved the first generic cortisone on January 3, 1972. 9 generic applications are approved; 0 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 cortisone from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

1950 earliest approval on file
1972 first generic approved

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

What does the cortisone label say about other medicines?

The cortisone label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 12 other medicines name cortisone. 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
Hydrocortisone	warnings	Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.

Other labels that name cortisone

Check cortisone against other medicines

Source: FDA drug label (Cortisone Acetate), Chartwell RX, LLC, effective June 6, 2025 (SPL set cc158d11-f356-4696-8b73-5d2681dcbcf2), via openFDA; the full label on DailyMed

What do FAERS reports show for cortisone?

The FDA Adverse Event Reporting System holds 12,274 reports that list cortisone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,750 are coded as a death and 5,225 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

Systemic Lupus Erythematosus6,277
Pain6,211
Pemphigus6,161
Drug Ineffective (a use or a product term, not a reaction)6,130
Alopecia6,061
Rheumatoid Arthritis6,021
Abdominal Discomfort5,958
Fatigue5,674

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 cortisone?

16 other medicines are given the same way (oral) and in the same FDA class as cortisone or labeled mainly for the same use (osteoarthritis), the same class first. Osteoarthritis lists all 27 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, Leukemia, lymphoma and myeloma	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, Leukemia, lymphoma and myeloma	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, Leukemia, lymphoma and myeloma	24 labelers	$0.121 per tablet 4 mg tablet	In shortage
Prednisolone	Osteoarthritis, Asthma, Allergies, Crohn's disease and ulcerative colitis, Herpes and shingles, Leukemia, lymphoma and myeloma	23 labelers	$0.568 per mL 15 mg/5 mL solution	No current entry
Budesonide	Asthma, Crohn's disease and ulcerative colitis	14 labelers	$0.498 per capsule 3 mg capsule	No current entry
Celecoxib	Osteoarthritis	65 labelers	$0.0762 per capsule 200 mg capsule	No current entry
Meloxicam	Osteoarthritis	43 labelers	$0.0166 per tablet 7.5 mg tablet	No current entry

Every medicine labeled for the same conditions as cortisone

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

What next?

Alternatives to cortisone: 16 medicines for the same use
Other corticosteroids: the pharmacologic class, with prices and generics
Cortisone side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other