hydrocortisone butyrate
Regulatory sources consulted
Approved indications
- Topical treatment of mild to moderate atopic dermatitis from 3 months of age.
Clinical warnings
- Major warning · It may cause reversible HPA-axis suppression, glucocorticoid insufficiency, Cushing syndrome, hyperglycemia, or glucosuria. Risk increases with large areas, occlusion, prolonged use, an impaired skin barrier, liver failure, and young age. — DailyMed/openFDA, SPL set ID 160c463e-80d2-4bca-8b7f-42279617e309
- Major warning · Avoid the eyes; topical corticosteroids may increase cataract and glaucoma risk. Treat concomitant skin infections and stop if allergic contact dermatitis is confirmed. — DailyMed/openFDA, SPL set ID 160c463e-80d2-4bca-8b7f-42279617e309
Drug interactions
- ModerateOther corticosteroid-containing products
Mechanism: Simultaneous use may increase total systemic corticosteroid exposure.
Recommendation: Minimize concomitant use and monitor for systemic effects.
DailyMed/openFDA, SPL set ID 160c463e-80d2-4bca-8b7f-42279617e309https://api.fda.gov/drug/label.json?search=openfda.spl_set_id:160c463e-80d2-4bca-8b7f-42279617e309
Adverse events
Common (≥1%)
Application-site reactions such as burning, pruritus, dermatitis, erythema, or irritation
Rare but serious
Hypothalamic–pituitary–adrenal axis suppression · Cataract or glaucoma
Pregnancy and lactation
Available human data have not identified an associated risk, but they are limited and animal studies showed reproductive toxicity. Use after assessing benefit and risk. During breastfeeding, use on the smallest area for the shortest possible time and wash any area at risk of direct infant contact before feeding.
Recent literature (PubMed)
Topical steroids may help prevent capecitabine-induced hand-foot syndrome in patients with colorectal cancer, as inflammation is involved in anti-tumor agent-induced hand-foot syndrome development. We assessed the preventive efficacy of medium-class topical corticosteroids for capecitabine-induced hand-foot syndrome in patients receiving adjuvant chemotherapy for colorectal cancer. This open-label, single-arm, single-center phase II study included patients with colorectal cancer receiving adjuvant chemotherapy with capecitabine + oxaliplatin. Prophylactic topical hydrocortisone butyrate (0.1%) was applied to the palms and soles from day 1 of adjuvant chemotherapy. The primary endpoint was grade ≥ 2 hand-foot syndrome incidence within four cycles. Secondary endpoints were the time to onset and incidence of each hand-foot syndrome grade, dose reduction, schedule delay, hand-foot syndrome-induced discontinuation, and other adverse events. Fifty patients were enrolled; three were excluded. Among the 47 included (median age = 54.5 years), 100% had Eastern Cooperative Oncology Group performance status 0, 36.1% were male, and 95.7% had pathological stage III disease. Hand-foot syndrome induced dose reduction, schedule delay, and discontinuation were required in 0, 2, and 0 patients, respectively, with a median relative capecitabine dose intensity of 100% within four cycles. Grade ≥ 2 hand-foot syndrome incidence during the cycles was 6.4%. Time to onset of grades ≥ 1 and ≥ 2 was 63.5 and 105.5 days, respectively. One patient experienced grade 3 hand-foot syndrome on day 164. The most common grade ≥ 2 adverse events were peripheral sensory neuropathy and neutropenia. No topical hydrocortisone butyrate (0.1%)-induced adverse events occurred. Topical hydrocortisone butyrate (0.1%) may prevent capecitabine-induced hand-foot syndrome. Trial registration number and date of registration: This clinical trial is registered in the Japan Registry of Clinical Trials (jRCT) as jRCTs031