What the label lists and what reports show
Tirbanibulin side effects
Tirbanibulin's FDA label: “Most common adverse reactions (incidence ≥2%) are local skin reactions, application site pruritus, and application site pain.” FAERS holds 244 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 application site erythema (35 reports).
- No generic listed
Check it at the source: the tirbanibulin FDA label on DailyMed (effective June 24, 2026, 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 KLISYRI?KLISYRI may cause serious side effects, including: Eye irritation can happen if KLISYRI gets into your eyes. If you accidently get KLISYRI into your eyes, flush them with water and get medical care as soon as possible. Local skin reactions are common but can also be severe during treatment with KLISYRI. Call your healthcare provider if you develop any local skin reactions including redness, flaking or scaling, crusting, or swelling that is more severe, or if you get blisters, peeling, pus, ulcers, or breakdown of your skin. The most common side effects of KLISYRI include: itching or pain in the treatment area. These are not all of the possible side effects of KLISYRI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Almirall, LLC, effective June 24, 2026 (SPL set 589c8de8-b773-4d47-b60c-48471806cccc), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥2%) are local skin reactions, application site pruritus, and application site pain.
Table 1 Post-Baseline Local Skin Reactions in the Treatment Area (face or scalp) - Pooled Data from 2 Controlled Clinical Phase 3 Trials
| Local Skin Reactions | Mild n (%) | Moderate n (%) | Severe n (%) | Mild n (%) | Moderate n (%) | Severe n (%) |
|---|---|---|---|---|---|---|
| Erythema | 76 (22%) | 223 (63%) | 22 (6%) | 98 (28%) | 20 (6%) | 0 |
| Flaking/ Scaling | 92 (26%) | 166 (47%) | 31 (9%) | 86 (25%) | 33 (9%) | 1 (<1%) |
| Crusting | 107 (30%) | 50 (14%) | 7 (2%) | 31 (9%) | 8 (2%) | 0 |
| Swelling | 102 (29%) | 32 (9%) | 2 (<1%) | 15 (4%) | 1 (<1%) | 0 |
| Vesiculation/ Pustulation | 25 (7%) | 2 (<1%) | 2 (<1%) | 3 (<1%) | 0 | 0 |
| Erosion/ Ulceration | 32 (9%) | 9 (3%) | 0 | 10 (3%) | 0 | 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, continuedMost common adverse reactions (incidence ≥2%) are local skin reactions, application site pruritus, and application site pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Almirall, at 1-866-665-2782 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. Two double-blind, vehicle-controlled clinical trials were conducted in 702 adult subjects with actinic keratosis on the face or scalp. Subjects were randomized 1:1 to KLISYRI or vehicle. Subjects enrolled in the trials had 4 to 8 clinically typical, visible, and discrete AK lesions in a contiguous area of 25 cm 2 on the face or scalp. Subjects’ average age was 70 years (range 45 to 96 years) and they were predominantly White (99%), male (87%), with Fitzpatrick skin types I or II (72%) and actinic keratosis on the face (68%) or scalp (32%). Treatment groups were comparable across all demographics and baseline characteristics, including AK lesion count and distribution on the face or scalp. In the controlled trials, local skin reactions (LSRs) were collected independent of adverse events.
Source: FDA drug label, Almirall, LLC, effective June 24, 2026 (SPL set 589c8de8-b773-4d47-b60c-48471806cccc), via openFDA; the full label on DailyMed
What do FAERS reports show?
244 reports list tirbanibulin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 9 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 22 reactions below, 6 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?
- Tirbanibulin: 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