What the label lists and what reports show
Halobetasol side effects
Halobetasol's FDA label lists its adverse reactions in its own words. FAERS holds 1,336 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pruritus (121 reports).
- Generic listed
Check it at the source: the halobetasol FDA label on DailyMed (effective June 29, 2026, Encube Ethicals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of BRYHALI?BRYHALI may cause serious side effects, including: • BRYHALI can pass through your skin. Too much BRYHALI passing through your skin can cause adrenal glands to stop working. • Cushing’s syndrome, a condition that happens when your body is exposed to too much of the hormone cortisol. • High blood sugar (hyperglycemia). • Skin reactions at the treated skin site. Tell your doctor if you get any skin reactions or skin infections. • Vision problems. BRYHALI may increase your chance of developing cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with BRYHALI. • Effects on growth and weight in children. The most common side effects of BRYHALI include burning, stinging, itching, dryness (application site dermatitis), upper respiratory tract infection and high blood sugar (hyperglycemia). […]
Source: FDA drug label (Bryhali), Bausch Health US, LLC, effective June 1, 2020 (SPL set d4bbb66a-3f9d-4091-b1b0-1cbc908432d3), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsADV ERSE REACTIONS In controlled clinical trials, the most frequent adverse events reported for halobelasol propionate ointment included stinging or burning in 1.6% of the patients. Less frequently reported adverse reactions were pustulation, erythema, skin atrophy, leukoderma, acne, itching, secondary infection, telangiectasia, urticaria, dry skin, miliaria, paresthesia, and rash. The following additional local adverse reactions are reported infrequently with topical corticosteroids, and they may occur more frequently with high potency corticosteroids, such as halobetasol propionate ointment. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. …
Source: FDA drug label, Encube Ethicals, Inc., effective June 29, 2026 (SPL set d4f03a79-3d5e-4a39-8ab0-8ebd3d804e39), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,336 reports list halobetasol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 28 are coded as a death and 176 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Halobetasol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions