Hydrocortisone Valerate

Generic: HYDROCORTISONE VALERATE

Prescription DrugTOPICAL

Drug Information

Brand Name
Hydrocortisone Valerate
Generic Name
HYDROCORTISONE VALERATE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Product Type
Prescription Drug
Route
TOPICAL
Application Number
18db91a0-fe67-4740-8a37-d656707356f1

Indications & Usage

INDICATIONS AND USAGE Hydrocortisone valerate ointment, 0.2% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.

Warnings

No specific warnings reported by FDA for this product.

Adverse Reactions

Adverse Reactions In controlled clinical trials, the total incidence of adverse reactions associated with the use of hydrocortisone valerate ointment, 0.2% was approximately 12%. These included worsening of condition (2%), transient itching (2%), irritation (1%) and redness (1%). In controlled clinical studies involving pediatric atopic dermatitis patients 2 through 12 years of age (n=64), the incidence of adverse experiences was approximately 28.1%, which is higher than that seen in adult patie...

Read full adverse reactions

Adverse Reactions In controlled clinical trials, the total incidence of adverse reactions associated with the use of hydrocortisone valerate ointment, 0.2% was approximately 12%. These included worsening of condition (2%), transient itching (2%), irritation (1%) and redness (1%). In controlled clinical studies involving pediatric atopic dermatitis patients 2 through 12 years of age (n=64), the incidence of adverse experiences was approximately 28.1%, which is higher than that seen in adult patients. Reported reactions included eczema (12.5%), pruritis (6%), stinging (2%), and dry skin (2%). Patients were not specifically evaluated for signs of atrophy (thinning, telangiectasia, erythema). No studies were performed to assess adrenal suppression and/or growth suppression. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.

Hydrocortisone Valerate - Side Effects, Warnings, Uses | FDA Drug Database