Objective  To mine adverse drug event (ADE) signals of doxycycline using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, and provide scientific evidence for clinical medication safety.

Methods  The data from the FAERS database between the first quarter of 2004 and the first quarter of 2024 were extracted. After data cleaning and standardization, ADE reports with doxycycline as the main suspected drug were screened. The system organ class (SOC) of ADE was performed using MedDRA, and the reporting odds ratio method and Medicines and Healthcare products Regulatory Agency method were used to mine ADE signals. The information component method was also used to evaluate signal strength.

Results  A total of 43 126 ADE reports with doxycycline as the primary suspected drug were collected, involving 14 642 patients, with a higher proportion of female patients (57.32%). There were 555 related ADE signals involving 26 SOC, with the top 5 SOC being gastrointestinal disorders, skin and subcutaneous tissue disorders, injuries, poisonings, and procedural complications, psychiatric disorders, and infections and infestations. The top 5 ADE signals with the highest signal intensity were Hatch reaction, sclerosing cholangitis, esophageal ulcer, gastrointestinal mucosal necrosis, and gastrointestinal injury. Among the ADE signals with the strongest signal strength not listed in the package insert, the top five were sclerosing cholangitis, nephrogenic diabetes insipidus, minimal change glomerular nephritis, diabetes insipidus and Sixth cranial nerve paralysis.

Conclusion  In clinical practice, particular attention should be paid to the frequent ADEs caused by doxycycline, as well as those not yet documented in the package insert, which involve multiple SOC such as renal and urinary disorders, hepatobiliary diseases, blood and lymphatic system disorders, and endocrine disorders. Therefore, clinical pharmacists should play a key role in assisting clinicians to develop and implement prevention plans for ADEs, thereby improving the safety of doxycycline in clinical use.

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