What the label lists and what reports show
Halobetasol and tazarotene side effects
Halobetasol and tazarotene's FDA label: “The most common adverse reactions are contact dermatitis (7%), application site pain (3%), folliculitis (2%), skin atrophy (2%), and excoriation (2%).” FAERS holds 198 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 (16 reports).
- No generic listed
Check it at the source: the halobetasol and tazarotene FDA label on DailyMed (effective January 1, 2020, Bausch Health US, LLC); 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 DUOBRII?DUOBRII may cause side effects, including: • See “What is the most important information I should know about DUOBRII?” • DUOBRII can pass through your skin. Too much DUOBRII 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). • Effects of growth and weight in children. • Skin irritation. DUOBRII may cause increased skin irritation. Tell your healthcare provider if you develop any skin irritation during your treatment with DUOBRII. If you develop skin irritation, your healthcare provider may tell you to interrupt or stop using DUOBRII, or tell you to use DUOBRII less often. • Sensitivity to light and risk of sunburn. See “What should I avoid during treatment with DUOBRII?” • Vision problems. […]
Source: FDA drug label, Bausch Health US, LLC, effective January 1, 2020 (SPL set b3f0cdc0-69fd-43d1-baf2-d776a3a20715), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions are contact dermatitis (7%), application site pain (3%), folliculitis (2%), skin atrophy (2%), and excoriation (2%).
Table 1: Adverse Reactions Occurring in ≥1% of the Subjects Treated with DUOBRII Lotion through Week 8
| Adverse Reaction | DUOBRII Lotion (N=270) | Vehicle Lotion (N=140) |
|---|---|---|
| Contact Dermatitis | 20 (7%) | 0 |
| Application Site Pain | 7 (3%) | 1 (1%) |
| Folliculitis | 5 (2%) | 0 |
| Skin Atrophy | 5 (2%) | 0 |
| Excoriation | 5 (2%) | 0 |
| Rash | 4 (1%) | 0 |
| Skin Abrasion | 3 (1%) | 0 |
| Skin Exfoliation | 2 (1%) | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most common adverse reactions are contact dermatitis (7%), application site pain (3%), folliculitis (2%), skin atrophy (2%), and excoriation (2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 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 clinical practice. In randomized, double-blind, multicenter, vehicle-controlled clinical trials, 410 adults with plaque psoriasis were treated with DUOBRII Lotion or vehicle lotion and had post-baseline safety data. Subjects applied DUOBRII Lotion or vehicle lotion once daily for up to 8 weeks. Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with DUOBRII Lotion and more frequently than in vehicle-treated subjects. Table 1: Adverse Reactions Occurring in ≥1% of the Subjects Treated with DUOBRII Lotion through Week 8 Adverse Reaction DUOBRII Lotion (N=270) Vehicle Lotion (N=140) Contact Dermatitis 20 (7%) 0 Application Site Pain 7 (3%) 1 (1%) Folliculitis 5 (2%) 0 Skin Atrophy 5 (2%) 0 Excoriation 5 (2%) 0 Rash 4 (1%) 0 Skin Abrasion 3 (1%) 0 Skin Exfoliation 2 (1%) 0
Source: FDA drug label, Bausch Health US, LLC, effective January 1, 2020 (SPL set b3f0cdc0-69fd-43d1-baf2-d776a3a20715), via openFDA; the full label on DailyMed
What do FAERS reports show?
198 reports list halobetasol and tazarotene among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 13 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 19 reactions below, 4 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.
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 and tazarotene: 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