Objective To explore the potential adverse reactions of acalabrutinib by mining and analyzing the pharmacovigilance signal of acalabrutinib, to provide a reference for clinically safe and rational drug use.

Methods Data related to acalabrutinib in the FAERS database were searched, and pharmacovigilance signals were obtained using the disproportionality measurement.

Results A total of 3, 155 reports of adverse events with acalabrutinib as the primary suspected drug were extracted, and 73 warning signals were detected involving 15 system organ classifications, 36 of which were not included in the drug instructions of acalabrutinib. The strong signals of acalabrutinib were mainly concentrated in various inflammatory and bleeding, anemia, contusion, atrial fibrillation, and so on. The largest number of system organ classification signals were focused on the blood and lymphatic system disorders, investigations, infections, and so on. In addition, the drug may cause tachycardia, brittle nails, and other warning signs. Through further analysis of gender-related adverse events, there were a total of 49 high-risk signals with gender differences found. Herein, male patients should pay attention to adverse reactions in bleeding, heart, urinary system, hypertension, and so on; meanwhile, female patients should be alert to adverse reactions in liver function, skin inflammation, and so on.

Conclusion A total of 36 drug warning signs that are not mentioned in the instructions for acalabrutinib are mined using FAERS, and blood, infection, and cardiac toxicity require special attention. Thus, these signals should be detected promptly for effective prevention in clinical medication to reduce the risk of medication use for patients.