Objective  To evaluate the safety of off-indication pyrotinib for HER2-mutated non-small cell lung cancer (NSCLC).

Methods  A restrospective study was used to analyze the data of inpatients using pyrotinib maleate for the treatment of HER2-mutated NSCLC from January 2020 to December 2022 in a cancer hospital, including patient information, medication information and occurrence of adverse reactions, etc., and its clinical drug safety was evaluated.

Results  A total of 46 cases of HER2-mutated NSCLC patients treated with pyrotinib were collected, including 19 males and 27 females. Adverse reactions occurred in 42 patients, with an incidence rate of 91.30%. Common adverse reactions included gastrointestinal toxicity, skin toxicity, and liver toxicity, and most of the adverse reactions were mild and moderate.

Conclusion  Adverse reactions of off-indication use of pyrotinib in HER2-mutated NSCLC are common, but the degree is relatively mild, and the safety is good. Most of the adverse reactions can be tolerated after timely symptomatic treatment.

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