Are non-serious adverse reactions to psychiatric drugs really non-serious?

Marco Pozzi, Silvana Bertella, Dario Cattaneo, Massimo Molteni, Valentina Perrone, Carla Carnovale, Stefania Antoniazzi, Emilio Clementi, Sonia Radice

Research output: Contribution to journalArticlepeer-review


Objective: The EudraVigilance Pharmacovigilance system classifies the seriousness of adverse drug reactions (ADRs) based on the requirement of hospital care. To date, no systematic study has been conducted on the impact of non-serious ADRs, in terms of therapy continuation and course of the underlying disease. We analyzed a pediatric population receiving psychiatric care and subjected to drug treatment, to assess whether non-serious ADRs do or do not have a relevant clinical impact. Methods: Data from a 1 year period were collected, which included: Administered drugs, choices made to manage the ADRs, the long-term (6 month) effect of these interventions on the course of the reaction, and their impact on the drug treatment for the underlying pathology. Results: Observed ADRs were concordant with those previously described for the same drug classes, and mainly comprised alterations of behavior, mood, and sleep (53%) and excessive variations of appetite and body weight (39%). The type of drug influenced the management decision, as we found that drug discontinuation was the most frequent strategy employed to resolve ADRs, especially with drugs employed in the treatment of attention-deficit/hyperactivity disorders (63%, p

Original languageEnglish
Pages (from-to)394-400
Number of pages7
JournalJournal of Child and Adolescent Psychopharmacology
Issue number6
Publication statusPublished - Aug 1 2013

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pediatrics, Perinatology, and Child Health
  • Psychiatry and Mental health


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