Overview

Betamethasone is a long-acting corticosteroid with immunosuppressive and antiinflammatory properties. It can be used topically to manage inflammatory skin conditions such as eczema, and parenterally to manage several disease states including autoimmune disorders. Betamethasone has potent glucocorticoid activity and negligible mineralocorticoid activity.

Indication

As a member of the corticosteroid family, betamethasone is indicated for the treatment of several inflammatory conditions. As topical monotherapy, betamethasone is indicated to relieve pruritic and inflammatory symptoms of corticosteroid-responsive-dermatoses. Betamethasone can be used topically in combination with a vitamin D analog such as calcipotriene to treat plaque psoriasis. The corticosteroid is also available as an injectable suspension and can be used to manage a range of inflammatory conditions including endocrine disorders, gastrointestinal disorders, and rheumatic disorders among other conditions.

Associated Conditions

Acute Gouty Arthritis
Adrenocortical Insufficiency
Alopecia Areata (AA)
Ankylosing Spondylitis (AS)
Atopic Dermatitis
Berylliosis
Blepharitis allergic
Blepharoconjunctivitis
Bullous dermatitis herpetiformis
Bursitis
Congenital Adrenal Hyperplasia (CAH)
Congenital Hypoplastic Anemia
Conjunctivitis
Dermatomyositis (DM)
Dermatosis
Discoid Lupus Erythematosus (DLE)
Edema of the cerebrum
Epicondylitis
Episcleritis
External ear inflammation
Eye allergy
Hypercalcemia of Malignancy
Inflammatory Reaction of the ear
Iridocyclitis
Iritis
Itching caused by Allergies
Keloids Scars
Keratitis
Keratitis interstitial
Keratoconjunctivitis
Leukemias
Lichen Planus (LP)
Lichen simplex chronicus
Lupus Erythematosus
Lymphoma
Multiple sclerosis exacerbation
Mycosis Fungoides (MF)
Necrobiosis lipoidica diabeticorum
Nephrotic Syndrome
Ocular Inflammation
Ocular injuries
Ophthalmia, Sympathetic
Pemphigus
Plaque psoriasis of the body
Plaque psoriasis of the scalp
Polymyositis
Post Surgical Ocular Inflammation
Pruritus
Psoriasis
Psoriasis Vulgaris (Plaque Psoriasis)
Psoriatic Arthritis
Psoriatic plaque
Pulmonary Tuberculosis (TB)
Pure Red Cell Aplasia
Regional Enteritis
Rheumatoid Arthritis
Rheumatoid Arthritis, Juvenile
Scleritis
Secondary thrombocytopenia
Severe Asthma
Severe Atopic Dermatitis
Skin Infections
Stevens-Johnson Syndrome
Systemic Lupus Erythematosus
Temporal Arteritis
Trichinosis
Tuberculous Meningitis
Ulcerative Colitis
Uveitis
Verrucous Lichen Planus (LP)
Acquired immune hemolytic anemia
Acute nonspecific tenosynovitis
Acute rheumatic carditis
Bacterial blepharitis
Corticosteroid-responsive dermatoses
Eczematous rash
Exfoliative erythroderma
Granuloma annulare lesions
Idiopathic eosinophilic pneumonias
Non-suppurative Thyroiditis
Ocular bacterial infections
Severe Allergic rhinitis
Severe Contact dermatitis
Severe Serum sickness
Severe Transfusion Reactions
Severe drug hypersensitivity reactions
Superficial ocular infections
Symptomatic Sarcoidosis
Synovitis of osteoarthritis

Research Report

Published: Jul 28, 2025

[Betamethasone (DB00443): A Comprehensive Pharmacological and Clinical Monograph]

Section 1: Introduction and Drug Identification

1.1 Overview and Historical Context

Betamethasone is a potent, long-acting synthetic corticosteroid belonging to the glucocorticoid class of steroid hormones.[1] It is a fluorinated derivative of prednisolone, engineered to possess high glucocorticoid (anti-inflammatory) activity while exhibiting negligible mineralocorticoid (salt-retaining) effects.[2] This selective pharmacological profile makes it a cornerstone therapeutic agent for managing a vast spectrum of inflammatory, allergic, and autoimmune disorders.

The development of betamethasone represents a significant milestone in medicinal chemistry. Patented in 1958 and subsequently approved for medical use in the United States in 1961, it provided clinicians with a powerful new tool for controlling inflammation.[1] Its enduring clinical importance is underscored by its inclusion on the World Health Organization's (WHO) List of Essential Medicines, specifically for its cream and ointment formulations, which are considered fundamental for a basic health system.[1] Its widespread use continues to this day; in 2022, it was the 263rd most commonly prescribed medication in the United States, accounting for over 1 million prescriptions.[1]

Chemically, betamethasone is a stereoisomer of dexamethasone, another widely used synthetic corticosteroid. The two molecules share the same chemical formula and atomic connectivity but differ in the three-dimensional arrangement of the methyl group at the C-16 position of the steroid nucleus.[1] In betamethasone, this group is in the beta (

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Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
Amnion-Based Injections in the Shoulder	2018/12/10	NCT03770546	Not Applicable	Withdrawn	University of Alabama at Birmingham
Local Steroid Treatment for Idiopathic Granulomatous Mastitis (LSTIGM)	2018/12/06	NCT03766997	Phase 4	UNKNOWN	Peking Union Medical College Hospital
Evaluation of the Vasoconstriction Properties of MC2-01 Cream	2018/11/29	NCT03758365	Phase 1	Completed	MC2 Therapeutics
To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064%, in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis).	2018/11/06	NCT03731091	Phase 3	Completed	Glenmark Pharmaceuticals Ltd. India
Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study	2018/10/16	NCT03707795	Early Phase 1	Completed	Edward Kasaraskis
Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia	2018/10/11	NCT03702959	N/A	UNKNOWN	Rambam Health Care Campus
India Dexamethasone and Betamethasone	2018/09/13	NCT03668860	Phase 1	Completed	Children's Hospital Medical Center, Cincinnati
Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamic Effect of Different Concentrations of a New Anti-inflammatory Substance in Subjects With Chronic Plaque Psoriasis	2018/09/13	NCT03669757	Phase 1	Completed	LEO Pharma
Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque Psoriasis	2018/03/19	NCT03469336	Phase 1	Completed	Pfizer
Effect of Antenatal Corticosteroids on Neonatal Morbidity.	2018/02/27	NCT03446937	Not Applicable	Completed	Ahmadu Bello University Teaching Hospital

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Betamethasone Dipropionate	Proficient Rx LP	63187-286	TOPICAL	0.5 mg in 1 g	1/1/2021
Betamethasone Dipropionate	H.J. Harkins Company, Inc.	52959-124	TOPICAL	0.5 mg in 1 g	1/3/2012
Betamethasone Valerate	A-S Medication Solutions	50090-3794	TOPICAL	1.2 mg in 1 g	5/5/2022
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Direct Rx	72189-182	TOPICAL	0.5 mg in 1 g	2/22/2021
Clotrimazole and Betamethasone Dipropionate	Physicians Total Care, Inc.	54868-4546	TOPICAL	0.64 mg in 1 g	5/1/2012
Betamethasone Dipropionate	A-S Medication Solutions	50090-5260	TOPICAL	0.5 mg in 1 g	10/18/2018
calcipotriene and betamethasone dipropionate	Bryant Ranch Prepack	63629-8618	TOPICAL	0.5 mg in 1 g	7/17/2023
Clotrimazole and Betamethasone Dipropionate	RPK Pharmaceuticals, Inc.	53002-9740	TOPICAL	0.5 mg in 1 g	5/5/2021
Betamethasone dipropionate	Northstar Rx LLC.	16714-996	TOPICAL	0.5 mg in 1 g	11/24/2022
Betamethasone Dipropionate	Physicians Total Care, Inc.	54868-6292	TOPICAL	0.5 mg in 1 g	10/3/2011

EMA Drug Approvals

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Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
DAIVOBET OINTMENT	LEO LABORATORIES LIMITED	SIN12241P	OINTMENT	0.5 mg/g	3/27/2003
BETACYLIC OINTMENT	Y.S.P. Industries (M) Sdn. Bhd.	SIN15211P	OINTMENT	0.5mg/g	4/12/2017
UNIFLEX-N CREAM	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	SIN01930P	CREAM	0.1% w/w	6/23/1988
B-MYCIN CREAM	Y.S.P. INDUSTRIES (M) SDN. BHD.	SIN14386P	CREAM	0.5mg/g	7/25/2013
GENTRISONE CREAM	SHIN POONG PHARMACEUTICAL CO LTD	SIN04989P	CREAM	0.64 mg/g	8/3/1990
BUFENCON INJECTION	YUNG SHIN PHARMACEUTICAL IND CO LTD	SIN07795P	INJECTION	2 mg/ml	7/15/1994

NMPA Drug Approvals

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

PPB Drug Approvals

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Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

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Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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

Saudi SFDA Drug Approvals

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

Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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