["Serious" adverse drug reactions with tramadol: a 2010-2011 pharmacovigilance survey in France]

Therapie. 2013 Mar-Apr;68(2):77-84. doi: 10.2515/therapie/2013021. Epub 2013 Jun 18.
[Article in French]


Objective: Tramadol is a weak opioid used as a step 2 analgesic, approved in France for moderate to severe pain. After dextropropoxyphene withdrawal, a national pharmacovigilance follow-up of tramadol was decided by the French Drug Agency.

Methods: All Serious Adverse Drug Reactions (SADR) notified with tramadol to the French PharmacoVigilance Centres (CRPV) and pharmaceutical companies between August 1(st), 2010 and July 31(th), 2011 were analyzed.

Results: During the study period, 296 cases of SADR were notified to CRPV and 59 to pharmaceutical companies. Apart from opiate-related SADR, tramadol induced serotoninergic SADR, including seizures or serotoninergic syndromes. Several « unlabelled » SADR were also identified: some of them, like hyponatremia or hypoglycemia, are poorly known by health professionals. Other were never published: peripheral edema or pancreatitis.

Conclusion: This study shows that besides well-known opioid or serotoninergic ADR, tramadol can also induce 2 other relatively unknown ADR: hypoglycemia and hyponatremia.

Publication types

  • English Abstract

MeSH terms

  • Adverse Drug Reaction Reporting Systems
  • Aged
  • Analgesics, Opioid / adverse effects*
  • Drug Industry
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • France
  • Humans
  • Hypoglycemia / chemically induced
  • Hypoglycemia / epidemiology
  • Hyponatremia / chemically induced
  • Hyponatremia / epidemiology
  • Male
  • Middle Aged
  • Pharmacovigilance
  • Tramadol / adverse effects*


  • Analgesics, Opioid
  • Tramadol