What the label lists and what reports show
Tazarotene side effects
Tazarotene's FDA label: “Most common adverse reactions occurring in 10 to 30% of patients are pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, and skin pain.” FAERS holds 1,167 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 erythema (82 reports).
- Generic listed
Check it at the source: the tazarotene FDA label on DailyMed (effective November 13, 2025, Almirall, 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 TAZORAC Gel?TAZORAC Gel may cause serious side effects, including: Skin irritation and allergic reactions (hypersensitivity). TAZORAC Gel may cause increased skin irritation (including blistering and skin peeling) and allergic reactions (including hives). Tell your doctor if you develop itching, burning, redness, blistering or peeling of your skin during treatment with TAZORAC Gel. If you develop skin irritation or hives, your doctor may tell you to temporarily stop using TAZORAC Gel until your skin heals, tell you to use TAZORAC Gel less often, or change your TAZORAC Gel dose. Also, wind or cold weather may be more irritating to your skin while you are using TAZORAC Gel. Sensitivity to sunlight and risk of sunburn. […]
Source: FDA drug label, NDA020600 (Chartwell Rx), as published by Almirall, LLC, effective November 13, 2025 (SPL set 4e4e4b81-420e-4492-8a74-80b692a80057), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions occurring in 10 to 30% of patients are pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, and skin pain.
Table 1. Incidence of Adverse Reactions in ≥1 % of Subjects Treated with FABIOR Foam
This table is printed in the FABIOR label published by Mayne Pharma of March 3, 2026; the label quoted above does not print one.
| Reaction | FABIOR Foam N = 744 | Vehicle Foam N = 741 |
|---|---|---|
| Patients with any adverse reaction, n (%) | 163 (22) | 19 (3) |
| Application site irritation | 107 (14) | 9 (1) |
| Application site dryness | 50 (7) | 8 (1) |
| Application site erythema | 48 (6) | 3 (<1) |
| Application site exfoliation | 44 (6) | 3 (<1) |
| Application site pain | 9 (1) | 0 |
| Application site photosensitivity (including sunburn) | 8 (1) | 3 (<1) |
| Application site pruritus | 7 (1) | 3 (<1) |
| Application site dermatitis | 6 (1) | 1 (<1) |
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 following serious adverse reactions are discussed in more detail in other sections of the labeling: • Embryofetal toxicity [see Warnings and Precautions ( 5.1 )] • Photosensitivity and Risk of Sunburn [see Warnings and Precautions ( 5.3 )] Plaque Psoriasis: Most common adverse reactions occurring in 10 to 30% of patients are pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, and skin pain. ( 6.1 ) Acne Vulgaris: Most common adverse reactions occurring in 10 to 30% of patients are desquamation, burning/stinging, dry skin, erythema and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan, Inc. at 1-800-678-1605 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. Psoriasis A total of 439 subjects 14 to 87 years of age were treated with TAZORAC Gel, 0.05% and 0.1% in two controlled clinical trials. The most frequent adverse events reported with TAZORAC Gel, 0.05% and 0.1% occurring in 10 to 30% of subjects, in descending order, included pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, and skin pain. …
Source: FDA drug label, NDA020600 (Chartwell Rx), as published by Almirall, LLC, effective November 13, 2025 (SPL set 4e4e4b81-420e-4492-8a74-80b692a80057), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,167 reports list tazarotene among the medicines taken, each a report of something that happened, not proof the medicine caused it; 15 are coded as a death and 167 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 20 reactions below, 10 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?
- 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