Betamethasone

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of betamethasone dipropionate cream (augmented) in corticosteroid responsive dermatoses is unknown.

• Betamethasone dipropionate cream (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. Betamethasone dipropionate cream (augmented), 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older.

• Betamethasone dipropionate cream (augmented), is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. Hypersensitivity to any component of this medicine.contraindicated

Apply a thin film of betamethasone dipropionate cream (augmented) to the affected skin areas once or twice daily. Therapy should be discontinued when control is achieved. Betamethasone dipropionate cream (augmented) is a high-potency corticosteroid. Treatment with betamethasone dipropionate cream (augmented) should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1) ]. Betamethasone dipropionate cream (augmented) should not be used with occlusive dressings unless directed by a physician. Avoid contact with eyes. Wash hands after each application. Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Betamethasone dipropionate cream (augmented) is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Apply a thin film to the affected skin areas once or twice daily. ( 2 ) Discontinue therapy when control is achieved. ( 2 ) Use no more than 50 g per week. ( 2 ) Do not use with occlusive dressings unless directed by a physician. ( 2 ) Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )

Effects on endocrine system: Betamethasone dipropionate cream (augmented) can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factor(s) include the use of high-potency topical corticosteroids, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. ( 5.1 , 8.4 ) Ophthalmic Adverse Reactions: Betamethasone dipropionate cream (augmented) may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. ( 5.2 ) 5.1 Effects on Endocrine System Betamethasone dipropionate cream (augmented) can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. Betamethasone dipropionate cream (augmented), 0.05% was applied once daily at 7 grams per day for 1 week to diseased skin, in adult subjects with psoriasis or atopic dermatitis, to study its effects on the HPA axis.

The most common adverse reaction reported in 0.4% of adult patients is stinging. ( 6.1 ) The most common adverse reactions reported in 10% of pediatric patients are signs of skin atrophy, telangiectasia, bruising, shininess. ( 6.1 , 8.4 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In controlled clinical trials, involving 242 adult subjects, the adverse reaction associated with the use of betamethasone dipropionate cream (augmented) reported at a frequency of 0.4% was stinging. It occurred in 1 subject. In a controlled clinical trial involving 67 pediatric subjects from 3 months to 12 years of age, the adverse reactions associated with the use of betamethasone dipropionate cream (augmented) occurred in 7 of 67 (10%) subjects. Reported reactions included signs of skin atrophy (telangiectasia, bruising, shininess). 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

8.1 Pregnancy Risk Summary There are no available data on betamethasone dipropionate cream (augmented) use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that betamethasone dipropionate cream (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate cream (augmented) on the smallest area of skin and for the shortest duration possible. In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits. The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of betamethasone dipropionate cream (augmented) (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

No pharmacokinetics trials have been conducted with betamethasone dipropionate cream (augmented), 0.05%. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

• Mar 3, 1965NDANDA014602Organon
• Mar 24, 1983NDANDA018642Cosette
• Jul 27, 1983NDANDA018741Organon
• Aug 31, 1983NDANDA018861Fougera Pharms Inc
• Aug 31, 1983NDANDA018865Fougera Pharms Inc
• Aug 31, 1983NDANDA018866Fougera Pharms Inc
• Jun 26, 1984NDANDA019137Fougera Pharms
• Sep 4, 1984NDANDA019141Fougera Pharms Inc

Recent PubMed references pinned to Betamethasone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Intravital Monitoring of Psoriasis Treatment Response and Drug Delivery Using Multiphoton Fluorescence Lifetime Imaging.
  Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI) · 2026 · Nguyen L, Mess C, Herberger K, et al.
  PMID 42277626DOI 10.1111/srt.70367
• Efficacy and safety of clobetasol propionate ophthalmic nanoemulsion for treating intraocular inflammation and pain associated with cataract surgery: two phase 3 multicentre, randomised, placebo-controlled, double-masked clinical studies.
  BMJ open · 2026 · Schwartz A, Wellish K, Zaman F, et al.
  PMID 42192627DOI 10.1136/bmjopen-2025-101177
• Topical clobetasol propionate 0.025% oral gel in the treatment of oral lichen planus: a double-blind, randomized placebo-controlled trial.
  BMC oral health · 2026 · Gränse F, Kroona L, Truedsson A, et al.
  PMID 42163196DOI 10.1186/s12903-026-08599-7
• Synergistic effects of glucocorticoid and N(2)-gas cold atmospheric plasma in a mouse model of atopic dermatitis.
  International immunopharmacology · 2026 · Ohira C, Komai N, Inaba Y, et al.
  PMID 42134290DOI 10.1016/j.intimp.2026.116812
• Single Intra-Articular Anakinra (IL-1Ra) Versus Betamethasone in Rabbit Post-Traumatic Knee Osteoarthritis: IL-8 Suppression and Chondrocyte Viability.
  Cell biochemistry and function · 2026 · Tepedelenlioğlu HE, Dayanir D, Elmazoğlu Z, et al.
  PMID 42130404DOI 10.1002/cbf.70230
• Clinical Efficacy of Local Injection of Compound Betamethasone Versus Triamcinolone Acetonide in the Treatment of Hypertrophic Scars: A Retrospective Analysis of 126 Patients.
  Journal of cosmetic dermatology · 2026 · Mao J, He M
  PMID 42108543DOI 10.1111/jocd.70903
• Prevention of oral mucositis in patients undergoing cancer chemotherapy using betamethasone mouthwash: A multicenter randomized controlled trial protocol.
  PloS one · 2026 · Soutome S, Hamada T, Nishi H, et al.
  PMID 41950207DOI 10.1371/journal.pone.0345991
• Complication after knee intra-articular betamethasone injection, a thrombocytopenic purpura: a case report.
  Journal of medical case reports · 2026 · Fauny M, Fresse A, Loeuille D, et al.
  PMID 41918115DOI 10.1186/s13256-026-05873-8

The 10 most recently updated of 500 ClinicalTrials.gov registrations naming Betamethasone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Influence of Dermocorticoids on Bone Mineral Density in Patients With Bullous Pemphigoid
  Completed · Phase 4 · Interventional · 47 enrolled · Centre Hospitalier Universitaire, Amiens
  NCT03926377updated 2026-06-12
• Comparison of the Efficacy of Clobetasol Propionate 0.05% Mouthwash, Photobiomodulation, and Their Combination in Managing of Oral Lesions in Patient With Pemphigus Vulgaris.
  Recruiting · Interventional · 30 enrolled · Damascus University
  NCT07641725updated 2026-06-11
• Efficacy of Topical Tapinarof Versus Betamethasone in the Treatment of Plaque Psoriasis
  Not yet recruiting · Phase 4 · Interventional · 120 enrolled · Pakistan Institute of Medical Sciences
  NCT07635043updated 2026-06-09
• Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 45 enrolled · Wei-Che Ko
  NCT05535738updated 2026-06-09
• Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib
  Active not recruiting · Phase 2 · Interventional · 305 enrolled · Janssen Research & Development, LLC
  NCT06120140updated 2026-06-05
• Comparison of Injection Techniques in Carpal Tunnel Syndrome
  Completed · Phase 4 · Interventional · 53 enrolled · Ankara Etlik City Hospital
  NCT07105540updated 2026-06-05
• Pre-incisional Infiltration With Ropivacaine Plus Diprospan for Relieving Postoperative Pain After Thoracoscopic Surgery
  Not yet recruiting · Interventional · 100 enrolled · Beijing Tiantan Hospital
  NCT07626489updated 2026-06-04
• Pre-incisional Infiltration With Ropivacaine Plus Diprospan for Relieving Postoperative Pain After Laparoscopic Surgery
  Not yet recruiting · Interventional · 150 enrolled · Beijing Tiantan Hospital
  NCT07626463updated 2026-06-04
• Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
  Recruiting · Phase 4 · Interventional · 528 enrolled · Second Affiliated Hospital, School of Medicine, Zhejiang University
  NCT07416916updated 2026-06-01
• Hybrid vs Fluoroscopy-Guided Interlaminar Epidural Injection in Lumbar Spinal Stenosis
  Not yet recruiting · Interventional · 44 enrolled · Marmara University
  NCT07612982updated 2026-05-29

Frequently asked questions

How does Betamethasone work?

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of betamethasone dipropionate cream (augmented) in corticosteroid responsive dermatoses is unknown.

What is Betamethasone used for?

According to FDA labeling, Betamethasone carries indications including: Betamethasone dipropionate cream (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. Betamethasone dipropionate cream (augmented), 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Betamethasone?

Betamethasone is classified as Corticosteroids, Corticosteroids acting locally, Corticosteroids/antiinfectives/mydriatics in combination, Corticosteroids, plain, Corticosteroids, potent (group III), Corticosteroids, potent, other combinations, Glucocorticoids, Corticosteroid, Corticosteroid Hormone Receptor Agonists, Glucocorticoid Receptor Agonists, Lipoxygenase Inhibitors, Antipruritic Activity, Carbohydrate Metabolism Alteration, Decreased Cellular Migration, Decreased Glucocorticoid Secretion, Decreased Leukotriene Activity, Decreased Lysosomal Function, Decreased Prostaglandin Activity, Decreased Protein Synthesis, Decreased Thromboxane Activity, Lipid Metabolism Alteration.

What are the brand names for Betamethasone?

Betamethasone is marketed under brand names including Betavet, Celestone Soluspan, Del-Beta, Diprolene, Duotic, Enstilar, Genone, GentaVed.

What are the contraindications for Betamethasone?

Betamethasone labeling lists contraindications including: Betamethasone dipropionate cream (augmented), is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. Hypersensitivity to any component of this medicine.. Always consult the full prescribing information and a clinician.