Adverse drug reactions to self-medication: a study in a pharmacovigilance database

Fundam Clin Pharmacol. 2015 Oct;29(5):517-20. doi: 10.1111/fcp.12140. Epub 2015 Aug 24.

Abstract

Although self-medication is widely developed, there are few detailed data about its adverse drug reactions (ADRs). This study investigated the main characteristics of ADRs with self-medication recorded in the Midi-Pyrénées PharmacoVigilance between 2008 and 2014. Self-medication included first OTC drugs and second formerly prescribed drugs later used without medical advice (reuse of previously prescribed drugs). Among the 12 365 notifications recorded, 160 (1.3%) were related to SM with 186 drugs. Around three-forth of the ADRs were 'serious'. Mean age was 48.8 years with 56.3% females. The most frequent ADRs were gastrointestinal and neuropsychiatric and main drug classes involved NSAIDs, analgesics, and benzodiazepines. Phytotherapy-homeopathy accounted for 9.1% of drugs.

Keywords: adverse drug reactions; analgesics; benzodiazepines; nonsteroidal anti-inflammatory agents; pharmacovigilance; self-medication.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Adverse Drug Reaction Reporting Systems*
  • Aged
  • Aged, 80 and over
  • Child
  • Child, Preschool
  • Databases, Factual
  • Drug-Related Side Effects and Adverse Reactions / diagnosis
  • Drug-Related Side Effects and Adverse Reactions / etiology*
  • Female
  • France
  • Humans
  • Infant
  • Male
  • Middle Aged
  • Nonprescription Drugs / adverse effects*
  • Pharmacovigilance*
  • Prescription Drug Misuse / adverse effects*
  • Risk Factors
  • Self Medication / adverse effects*
  • Severity of Illness Index
  • Time Factors
  • Young Adult

Substances

  • Nonprescription Drugs