Association of Adverse Events with Antibiotic Treatment for Urinary Tract Infection.

Background Little is known about the relative harms of different antibiotic regimens prescribed to treat uncomplicated urinary tract infection (UTI). We sought to compare the risk of adverse events associated with commonly-used oral antibiotic regimens for the outpatient treatment of uncomplicated UTI. Methods We identified 1,169,033 otherwise healthy, non-pregnant women aged 18-44 years with uncomplicated UTI who initiated an oral antibiotic with activity against common uropathogens from July 1, 2006 to September 30, 2015. We used propensity score-weighted Kaplan-Meier methods and Cox proportional hazards regression models to estimate the association between antibiotic agent and adverse events. Results Of two first-line agents, TMP/SMX (versus nitrofurantoin) was associated with higher risk of several adverse drug events including hypersensitivity reaction (hazard ratio [HR] 2.62, 95% CI 2.30-2.98), acute renal failure (HR 2.56, 95% CI 1.55-4.25), skin rash (HR 2.42, 95% CI 2.13-2.75), urticaria (HR 1.37, 95% CI 1.19-1.57), abdominal pain (HR 1.14, 95% CI 1.09-1.19), and nausea / vomiting (HR 1.18, 95% CI 1.10-1.28), but similar risk of potential microbiome-related adverse events. Compared to nitrofurantoin, non-first-line agents were associated with higher risk of several adverse drug events and potential microbiome-related adverse events including non-C. difficile diarrhea, C. difficile infection, vaginitis / vulvovaginal candidiasis, and pneumonia. Treatment duration modified the risk of potential microbiome-related adverse events. Conclusions The risks of adverse drug events and potential microbiome-related events differ widely by antibiotic agent and duration. These findings underscore the utility of using real-world data to fill evidentiary gaps related to antibiotic safety.