Tramadol dependence: a survey of spontaneously reported cases in Sweden

Pharmacoepidemiol Drug Saf. 2009 Dec;18(12):1192-8. doi: 10.1002/pds.1838.

Abstract

Background: Tramadol is a weak opioid analgesic, which is generally considered to be safe. However, conflicting data exist on the dependence potential of tramadol.

Objective: The aim of this study was to investigate occurrence of tramadol dependence and associated risk factors using spontaneously reported adverse drug reactions.

Methods: The Swedish database for spontaneously reported adverse drug reactions, Swedish Drug Information System (SweDIS), was searched for reports on tramadol dependence from 1 January 1995 until 31 December 2006. Selection was conducted based on the DSM-IV definition of dependence. Available information was scrutinised and registered and then presented descriptively.

Results: A total of 104 reports of tramadol dependence were identified, of which 60 (58%) concerned women. The median age (range) was 45 (15-84) years. Information on a history of substance abuse was present in 31 patients (30%) and 41 patients (39%) had a documented past or current use of a drug of abuse. Prescribed doses of tramadol ranged between 50-800 mg/day, and ingested doses between 50-4000 mg/day. Time of onset ranged from some weeks up to 4 years. In 72 (69%) cases the reaction was classified as serious, mainly due to hospitalisations for detoxification or discontinuation of tramadol.

Conclusions: There is an occurrence of tramadol dependence in association with analgesic treatment within the recommended dose range. In susceptible patients a severe and serious dependence syndrome may develop. A history of abuse or use of a drug of abuse seems to be an important risk factor.

MeSH terms

  • Adolescent
  • Adult
  • Adverse Drug Reaction Reporting Systems
  • Aged
  • Aged, 80 and over
  • Analgesics, Opioid / adverse effects*
  • Data Collection
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Male
  • Middle Aged
  • Opioid-Related Disorders / diagnosis
  • Opioid-Related Disorders / etiology*
  • Risk Factors
  • Substance Withdrawal Syndrome / diagnosis
  • Substance Withdrawal Syndrome / etiology
  • Sweden / epidemiology
  • Tramadol / adverse effects*

Substances

  • Analgesics, Opioid
  • Tramadol