{"id":"betamethasone-valerate","rwe":[],"_fda":{"id":"20c6d0ad-dd09-4901-8fc9-2e41184cb487","set_id":"02db1402-701c-483c-bfd6-8b7a543ae8ef","openfda":{"unii":["9IFA5XM7R2"],"route":["TOPICAL"],"rxcui":["197407"],"spl_id":["20c6d0ad-dd09-4901-8fc9-2e41184cb487"],"brand_name":["BETAMETHASONE VALERATE"],"spl_set_id":["02db1402-701c-483c-bfd6-8b7a543ae8ef"],"package_ndc":["50090-1647-0"],"product_ndc":["50090-1647"],"generic_name":["BETAMETHASONE VALERATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["BETAMETHASONE VALERATE"],"manufacturer_name":["A-S Medication Solutions"],"application_number":["ANDA072041"],"original_packager_product_ndc":["51672-1269"]},"version":"11","pregnancy":["Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time."],"overdosage":["OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS )."],"description":["DESCRIPTION Betamethasone Valerate Cream USP, 0.1% contains betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-valerate. The structural formula is: Molecular Formula: C 27 H 37 FO 6 Molecular Weight: 476.59 Each gram of Betamethasone Valerate Cream USP, 0.1% contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of ceteareth-15, cetyl alcohol, mineral oil, polyethylene glycol 1000, propylene glycol, purified water, stearyl alcohol, white petrolatum, phosphoric acid and sodium hydroxide (for pH adjustment); chlorocresol is present as a preservative. Chemical Structure"],"precautions":["PRECAUTIONS General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS-Pediatric Use ). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information For Patients Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed. The treated skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children."],"how_supplied":["HOW SUPPLIED Product: 50090-1647 NDC: 50090-1647-0 15 g in a TUBE / 1 in a CARTON"],"pediatric_use":["Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children."],"effective_time":"20241111","nursing_mothers":["Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman."],"laboratory_tests":["Laboratory tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test"],"pharmacokinetics":["Pharmacokinetics 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. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile."],"adverse_reactions":["ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria."],"contraindications":["CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation."],"description_table":["<table width=\"100%\" styleCode=\"Noautorules\"><colgroup><col width=\"35%\" align=\"right\" valign=\"top\"/><col width=\"30%\" align=\"center\" valign=\"top\"/><col width=\"35%\" align=\"left\" valign=\"top\"/></colgroup><tbody><tr><td colspan=\"3\" align=\"center\"><renderMultiMedia referencedObject=\"MM1\"/></td></tr><tr><td>Molecular Formula: C<sub>27</sub>H<sub>37</sub>FO<sub>6</sub></td><td/><td>Molecular Weight: 476.59</td></tr></tbody></table>"],"general_precautions":["General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS-Pediatric Use ). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled."],"teratogenic_effects":["Teratogenic Effects Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics 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. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile."],"indications_and_usage":["INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses."],"information_for_patients":["Information For Patients Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed. The treated skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings."],"spl_unclassified_section":["Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.","Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 Revised: February, 2015 PK-0759-6 372"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply a thin film of Betamethasone Valerate Cream USP, 0.1% to the affected skin areas one to three times a day. Dosage once or twice a day is often effective."],"spl_product_data_elements":["BETAMETHASONE VALERATE Betamethasone Valerate BETAMETHASONE VALERATE BETAMETHASONE mineral oil petrolatum polyethylene glycol 1000 ceteareth-15 cetyl alcohol stearyl alcohol propylene glycol AQUA phosphoric acid sodium hydroxide chlorocresol"],"package_label_principal_display_panel":["Betamethasone Valerate Label Image"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results."]},"tags":[{"label":"Corticosteroid","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Glucocorticoid receptor","category":"target"},{"label":"NR3C1","category":"gene"},{"label":"Cutaneous","category":"route"},{"label":"Topical","category":"route"},{"label":"Aerosol","category":"form"},{"label":"Cream","category":"form"},{"label":"Lotion","category":"form"},{"label":"Ointment","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Atopic dermatitis","category":"indication"},{"label":"Contact dermatitis","category":"indication"},{"label":"Dermatosis of scalp","category":"indication"},{"label":"Discoid lupus erythematosus","category":"indication"},{"label":"Eruption of skin","category":"indication"},{"label":"Granuloma annulare","category":"indication"},{"label":"Fougera Pharms Inc","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Anti-Asthmatic Agents","category":"pharmacology"},{"label":"Anti-Inflammatory Agents","category":"pharmacology"},{"label":"Glucocorticoids","category":"pharmacology"},{"label":"Hormones","category":"pharmacology"},{"label":"Respiratory System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1002 reports"},{"date":"","signal":"MACULAR DEGENERATION","source":"FDA FAERS","actionTaken":"626 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"567 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"451 reports"},{"date":"","signal":"MALAISE","source":"FDA FAERS","actionTaken":"414 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"408 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"398 reports"},{"date":"","signal":"WEIGHT DECREASED","source":"FDA FAERS","actionTaken":"390 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"389 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"322 reports"}],"commonSideEffects":[{"effect":"Skin atrophy","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Secondary infection","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Allergic contact dermatitis","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Maceration of the skin","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Burning","drugRate":"infrequently","severity":"mild"},{"effect":"Itching","drugRate":"infrequently","severity":"mild"},{"effect":"Irritation","drugRate":"infrequently","severity":"mild"},{"effect":"Dryness","drugRate":"infrequently","severity":"mild"},{"effect":"Folliculitis","drugRate":"infrequently","severity":"mild"},{"effect":"Hypertrichosis","drugRate":"infrequently","severity":"mild"},{"effect":"Acneiform eruptions","drugRate":"infrequently","severity":"mild"},{"effect":"Hypopigmentation","drugRate":"infrequently","severity":"mild"},{"effect":"Perioral dermatitis","drugRate":"infrequently","severity":"mild"},{"effect":"Miliaria","drugRate":"infrequently","severity":"mild"},{"effect":"Striae","drugRate":"infrequently","severity":"mild"}],"contraindications":["Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of the preparation."],"specialPopulations":{"Pregnancy":"Teratogenic Effects-- Pregnancy Category C. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only ","Paediatric use":"Safety and effectiveness in pediatric patients have not been established. Because of higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of HPA axis suppression and Cushings syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical cortico"}},"trials":[],"aliases":[],"company":"Fougera Pharms Inc","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BETAMETHASONE VALERATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:50:02.304602+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:50:09.450909+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:50:00.921810+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BETAMETHASONE VALERATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:50:10.275656+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:49:59.204537+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:49:59.204549+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:50:11.840478+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL10858/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:50:10.790521+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:50:16.162238+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA072041","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:49:59.204551+00:00"}},"allNames":["betamethasone valerate","bextasol","celeston valerate","valisone","bedermin"],"offLabel":[],"synonyms":["betamethasone valerate","bextasol","celeston valerate","valisone","bedermin"],"timeline":[{"date":"1967-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from SCHERING to Fougera Pharms Inc"},{"date":"1967-09-02","type":"positive","source":"DrugCentral","milestone":"FDA approval (Schering)"},{"date":"1983-03-24","type":"positive","source":"FDA Orange Book","milestone":"Beta-Val approved — EQ 0.1% BASE"},{"date":"1983-06-30","type":"positive","source":"FDA Orange Book","milestone":"Betaderm approved — EQ 0.1% BASE"},{"date":"1983-08-31","type":"positive","source":"FDA Orange Book","milestone":"New formulation approved (Fougera Pharms Inc)"},{"date":"1999-02-28","type":"positive","source":"FDA Orange Book","milestone":"Luxiq approved — 0.12% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"2023-04-18","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 11 manufacturers approved"}],"aiSummary":"Betamethasone Valerate is a corticosteroid medication that targets the glucocorticoid receptor to treat various skin conditions. Originally developed by Schering, it is now owned by Fougera Pharms Inc and has been FDA-approved since 1967 for conditions such as atopic dermatitis, contact dermatitis, and plaque psoriasis. As a small molecule corticosteroid, it is available as a generic medication with multiple manufacturers. Betamethasone Valerate is off-patent and has no active Orange Book patents. It is used to reduce inflammation and suppress the immune system in the treatment of various skin conditions.","brandName":"Betamethasone Valerate","ecosystem":[{"indication":"Atopic dermatitis","otherDrugs":[{"name":"abrocitinib","slug":"abrocitinib","company":"PFIZER Inc"},{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"}],"globalPrevalence":204050000},{"indication":"Contact dermatitis","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"},{"name":"benzoyl peroxide","slug":"benzoyl-peroxide","company":"Valeant Intl"}],"globalPrevalence":324000000},{"indication":"Dermatosis of scalp","otherDrugs":[{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"clobetasol propionate","slug":"clobetasol-propionate","company":"Fougera Pharms"}],"globalPrevalence":null},{"indication":"Discoid lupus erythematosus","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone benzoate","slug":"betamethasone-benzoate","company":"Parke Davis"}],"globalPrevalence":2400000},{"indication":"Eruption of skin","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"},{"name":"benzoyl peroxide","slug":"benzoyl-peroxide","company":"Valeant Intl"}],"globalPrevalence":null},{"indication":"Granuloma annulare","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"},{"name":"benzoyl peroxide","slug":"benzoyl-peroxide","company":"Valeant Intl"}],"globalPrevalence":null},{"indication":"Lichen simplex chronicus","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone benzoate","slug":"betamethasone-benzoate","company":"Parke Davis"}],"globalPrevalence":null},{"indication":"Plaque psoriasis","otherDrugs":[{"name":"adalimumab","slug":"adalimumab","company":"Abbvie Inc"},{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"alefacept","slug":"alefacept","company":"Astellas"},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"}],"globalPrevalence":125000000}],"mechanism":{"target":"Glucocorticoid receptor","novelty":"Follow-on","targets":[{"gene":"NR3C1","source":"DrugCentral","target":"Glucocorticoid receptor","protein":"Glucocorticoid receptor"}],"moaClass":"Corticosteroid Hormone Receptor Agonists","modality":"Small Molecule","drugClass":"Corticosteroid","explanation":"","oneSentence":"","technicalDetail":"Betamethasone Valerate is a synthetic glucocorticoid that exerts its effects by binding to the glucocorticoid receptor, which then translocates to the nucleus and regulates the expression of target genes involved in inflammation, including those encoding pro-inflammatory cytokines and enzymes."},"commercial":{"launchDate":"1967","_launchSource":"DrugCentral (FDA 1967-09-02, SCHERING)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/354","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BETAMETHASONE%20VALERATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BETAMETHASONE VALERATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T08:58:55.526033","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:50:17.250695+00:00","fieldsConflicting":5,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"alclometasone dipropionate","drugSlug":"alclometasone-dipropionate","fdaApproval":"1982-12-14","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"amcinonide","drugSlug":"amcinonide","fdaApproval":"1979-10-18","genericCount":4,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"auranofin","drugSlug":"auranofin","fdaApproval":"1985-05-24","patentStatus":"Unknown","relationship":"same-target"},{"drugName":"beclometasone dipropionate","drugSlug":"beclometasone-dipropionate","fdaApproval":"1976-05-12","relationship":"same-target"},{"drugName":"betamethasone","drugSlug":"betamethasone","fdaApproval":"1961-04-17","patentStatus":"Unknown","relationship":"same-target"},{"drugName":"betamethasone acetate","drugSlug":"betamethasone-acetate","fdaApproval":"1965-03-03","relationship":"same-target"},{"drugName":"betamethasone 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