OpenClaim

Tirbanibulin Side Effects

The most commonly reported side effects of tirbanibulin include application site erythema, erythema, and drug intolerance, based on 218 FDA adverse event reports from 2021 to 2025. 20.6% of reports found the drug to be ineffective.

Tirbanibulin side effects

Percentages show how often each reaction appears relative to total reports for tirbanibulin.

1
Drug Ineffective20.6%45
2
Application Site Erythema14.2%31
3
Erythema10.1%22
4
Drug Intolerance9.2%20
5
Application Site Exfoliation7.8%17
6
Adverse Drug Reaction7.8%17
7
Application Site Vesicles6.9%15
8
Off Label Use6.0%13
9
Application Site Pain5.5%12
10
Pruritus5.0%11
11
Application Site Dryness4.6%10
12
Application Site Pruritus4.1%9
13
Blister3.7%8
14
Skin Burning Sensation3.7%8
15
Burning Sensation3.2%7

These are voluntary reports and do not establish that tirbanibulin caused these reactions.

Report severity

17.9%Serious39 reports
4.1%Hospitalizations9 reports
0.5%Fatal1 reports

Seriousness is determined by the reporter, not by OpenClaim.

Tirbanibulin drug interactions

Other drugs that appear in adverse event reports alongside tirbanibulin. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Atezolizumab1.4%3
2
Cobimetinib-fumarate1.4%3
3
Vemurafenib1.4%3
4
Encorafenib0.9%2
5
Binimetinib0.9%2
6
Vismodegib0.5%1
7
Mycophenolate0.5%1

Taken alongside

1
Fluorouracil4.1%9
2
Imiquimod3.2%7
3
Omeprazole2.3%5
4
Ergocalciferol1.8%4
5
Magnesium-acetate-tetrahydrate1.8%4
6
Amlodipine1.8%4
7
Ascorbic-acid1.4%3
8
Candesartan-cilexetil1.4%3
9
Gentamicin-sulfate1.4%3
10
Prednisolone1.4%3
11
Pantoprazole-sodium1.4%3
12
Ibuprofen1.4%3
13
Pimecrolimus1.4%3
14
Diclofenac1.4%3
15
Amoxicillin1.4%3

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports tirbanibulin side effects

43.1% of tirbanibulin adverse event reports involve female patients and 33.0% involve male patients. The largest age group is elderly at 52%. These figures reflect who reports side effects, not underlying risk.

Sex

Female43.1%
Male33.0%
Unknown23.9%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6448.4%
65+51.6%

What is tirbanibulin used for

Conditions and purposes for which patients were taking tirbanibulin when the adverse event was reported.

Actinic KeratosisActinic CheilitisActinic KeratosisAdverse Drug ReactionAnogenital WartsBasosquamous CarcinomaCarcinoma In SituCervical DysplasiaChapped LipsHyperkeratosisNeoplasm ProphylaxisProduct Used For Unknown IndicationPrecancerous ConditionPrecancerous Skin LesionProduct Used For Unknown Indication

Showing 15 of 23 indications

Tirbanibulin brand names and reporting trend

Tirbanibulin is sold under the brand name Klisyri.

Brand names

Klisyri15

Quarterly reports (20212025)

2021202220242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking tirbanibulin with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.