ORIGINAL RESEARCH ARTICLE Frequency and Nature of Adverse Drug Reactions Due to Non- Prescription Drugs in Children: A Retrospective Analysis from the French Pharmacovigilance Database Genevie `ve Durrieu 1,2 • Mathieu Maupiler 1 • Vanessa Rousseau 1 • Leila Chebane 1 • Franc ¸ois Montastruc 1 • Emmanuelle Bondon-Guitton 1 • Jean-Louis Montastruc 1 Ó Springer International Publishing AG 2017 Abstract Introduction Studies that evaluate the safety of non-pre- scription drugs in children remain scarce. Objectives The aim of the present study was to compare adverse drug reactions (ADRs) due to prescription versus non-prescription drugs in children. Methods We conducted a retrospective analysis of ADR notifications for a pediatric population (aged \ 18 years) registered in the French PharmacoVigilance Database (FPVD) between January 1985 and December 2016 by the Midi-Pyre ´ne ´es PharmacoVigilance Center (in the south of France). We compared ADR profiles according to drug prescription status using a Chi-squared test. Results We included 2218 notifications concerning 3687 ADRs in the study. Non-prescription drugs were involved in 506 notifications (22.8%). Patients were younger in the non-prescription drug group (6.7 ± 5.3 vs. 8.4 ± 5.7 years in the prescription drug group). No difference by sex was found. Neurological ADRs were more frequent with pre- scription drugs (21.0%) than with non-prescription drugs (14.2%, p = 0.0008), whereas dermatological disorders (37.2 vs. 29.1%, respectively) and general ADRs (30.8 vs. 20.1%, respectively) were more frequent with non-pre- scription than with prescription drugs (p = 0.0006 and p \ 0.0001, respectively). The frequency of ‘‘serious’’ ADRs was higher with prescription drugs than with non- prescription drugs (40.9 vs. 34.2%, p = 0.007). The non- prescription drugs most frequently implicated with serious ADRs were ibuprofen (n = 37; 4.2%), tuberculosis vac- cine (n = 23; 2.6%), aspirin (n = 20, 2.3%), and parac- etamol (n = 17; 1.9%). ADRs from prescription drugs involved asparaginase (n = 27; 3.1%), immunoglobulins (n = 25; 2.9%), and amoxicillin (n = 23; 2.4%). Conclusions Non-prescription drugs, usually considered safe, were frequently responsible for ADR notifications. The non-prescription medication most frequently involved in serious ADRs was ibuprofen. Key Points Almost one-quarter of adverse drug reaction (ADR) notifications (22.8%) reported in children were associated with non-prescription drugs. About one- third of these (34.2%) were classed as serious. Regardless of the prescription status of the drugs, ibuprofen was the most frequently associated with serious ADRs. Vigilant surveillance of non-prescription drugs that are widely used in the pediatric population, especially by parents, is required. & Genevie `ve Durrieu genevieve.durrieu@univ-tlse3.fr 1 Service de Pharmacologie Me ´dicale et Clinique, Centre Midi- Pyre ´ne ´es de PharmacoVigilance, de Pharmacoe ´pide ´miologie et d’Informations sur les Me ´dicaments, Pharmacopo ˆle Midi- Pyre ´ne ´es, Toulouse University Hospital, UMR1027 INSERM Pharmacoepidemiology Unit, Faculty of Medicine, University of Toulouse, Toulouse, France 2 Laboratoire de Pharmacologie Me ´dicale et Clinique, Faculte ´ de Me ´decine, 37 Alle ´es Jules Guesde, 31000 Toulouse, France Pediatr Drugs DOI 10.1007/s40272-017-0255-z