SA18 - The drugs that mostly frequently induce acute kidney injury: a case−non-case study of a pharmacovigilance database

Thème : Veille et alertes sanitaires


Acute kidney injury (AKI) is associated with a high hospitalization rate, accelerated long-term decline in kidney function and a high mortality rate. Adverse drug reactions (ADRs) constitute one of the most important modifiable factors in the context of AKI. Most studies of drug-induced AKI have focused on a sole drug class. The objective of the present study was to establish a comprehensive overview of drug-induced AKI on the basis of spontaneously reported ADRs in the French national pharmacovigilance database (FPVD).


We performed a case-non-case study of drug-induced AKI. Cases corresponded to the reports of AKI recorded in the FPVD between January 1st, 2015, and December 31st, 2015. The non-cases corresponded to all other spontaneously reported ADRs (excluding AKI) recorded in the FPVD during the same period. Data were expressed as the reporting odds ratio (ROR) and the 95% confidence interval.


Of the 38782 ADRs recorded in the FPVD during the study period, 3.2% were classified as cases of AKI. A total of 1254 patients experienced AKI (males: 55%; mean ± standard deviation age: 68.7 ± 15.0). Overall, 15.2% of the patients required renal replacement therapy. Two or more concomitantly administered drugs were involved in 66% of the cases of AKI. The most frequently implicated drug classes were antibacterials for systemic use (29.5%), diuretics (18.5%), agents acting on the renin-angiotensin system (16.3%), antineoplastic agents (10.2%) and anti-inflammatory agents (5.4%). Gentamicin, eplerenone, spironolactone, candesartan, cisplatin and acyclovir had the highest RORs (>10).


A comprehensive study of a national pharmacovigilance database enabled us to identify the drug classes that most frequently induced AKI. Even though most of the identified drugs were already known to induce AKI, the present work should raise physicians’ awareness of the compounds responsible for triggering this potentially life-threatening condition.


  • GRAS Valérie
  • MORAGNY Julien
  • CHOUKROUN Gabriel
  • MASMOUDI Kamel
  • LIABEUF Sophie