Halobetasol is a corticosteroid sold in the U.S. under 3 brand and generic names, for facial dermatoses, foot dermatoses and hand dermatoses. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Ultravate (application NDA019967). Other halobetasol products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Apply a thin layer of ULTRAVATE lotion to the affected skin twice daily for up to two weeks. Rub in gently. Discontinue therapy when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary. Treatment beyond two weeks is not recommended and the total dosage should not exceed 50 grams (50 ml) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis {see Warnings and Precautions 5.1].Do not use with occlusive dressings unless directed by a physician. ULTRAVATE lotion is for external use only. Avoid use on the face, scalp, groin, or axillae. ULTRAVATE lotion is not for ophthalmic, oral, or intravaginal use. Apply a thin layer to the affected areas twice daily. (2) Limit use to 50 g/week. (2) Discontinue treatment when control is achieved. (2) If no improvement is seen within 2 weeks, reassess diagnosis. (2) Treatment beyond 2 consecutive weeks is not recommended. (2) Do not use with occlusive dressings unless directed by a physician. (2) Avoid use on the face, scalp, groin, or axillae. (2) Not for ophthalmic, oral, or intravaginal use. (2)
The most commonly reported adverse reactions (≥1%) are telangiectasia, application site atrophy, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LAcer Pharma, LLC at 1-888-403-8874 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 practice. During randomized, controlled, blinded clinical trials 277 adults with plaque psoriasis were treated with ULTRAVATE lotion twice daily for up to two weeks (up to approximately 50 grams/week). Table 1 presents adverse reactions that occured in at least 1% of subjects treated with ULTRAVATE lotion twice daily for up to two weeks, and more frequently than in vehicle-treated subjects. Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with ULTRAVATE Lotion for up to Two Weeks ULTRAVATE Lotion (N=277) Vehicle Lotion (N=259) Adverse Reaction % % Telangiectasia 1% 0% Application site atrophy 1% <1% Headache 1% <1% Less common dverse reactions (incidence less than 1% but greater than 0.1%) that occured in subjects treated with ULTRAVATE lotion included application site discoloration, herpes zoster, influenza, nasopharyngitis, otitis…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Topical | — | — | View → | |
| 2 | Not yet rated | Prescription | Topical | — | — | View → |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
None. None.
| 3 | Not yet rated | Prescription | Topical | — | — | View → |