Rationale & ObjectiveAdverse drug reactions (ADRs) are common in patients with chronic kidney disease (CKD). The impact of kidney function decline on serious ADR risk has been poorly investigated. We sought to comprehensively describe ADRs and assess the relationship between eGFR and serious ADR risk.Study DesignProspective cohort study.Setting & Participants3,033 participants in French Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) cohort study, a nationwide sample of nephrology outpatients with moderate-to-advanced CKD.PredictorsDemographic and biological data (including eGFR), medication prescriptions.OutcomesADRs (preventable or not) were prospectively identified from hospital discharge reports, medical records, and patient interviews. Expert pharmacologists used validated tools to adjudicate ADRs.Analytical ApproachRestricted cubic splines in fully adjusted cause-specific Cox proportional hazard models were used to evaluate the relationship between eGFR and the risk of serious ADRs (overall and by subtype).ResultsDuring a median follow-up period of 4.7 years, 360 patients experienced 488 serious ADRs. Kidney and urinary disorders (n=170) and hemorrhages (n=170) accounted for 70% of serious ADRs. The most common medications classes were antithrombotics and renin-angiotensin system inhibitors. The majority of those serious ADRs were associated with hospitalization (n=467), with 32 directly or indirectly associated with death, and 22 associated with life-threatening event. More than 27% of the 488 serious ADRs were preventable or potentially preventable. The eGFR is a major risk factor for serious ADRs. Risk of AKI was 2.2% higher and risk of bleeding ADRs were 8% higher for each 1 mL/min/1.73m2 lower baseline eGFR.LimitationsThe results cannot be extrapolated to patients who are not being followed up by a nephrologist.ConclusionsADRs constitute a major cause of hospitalization in CKD patients for whom lower eGFR level is a major risk factor.< Réduire