Buprenorphine-naloxone treatment in opioid dependence and risk of liver enzyme elevation: results from a 12-month observational study

Am J Addict. 2014 Nov-Dec;23(6):563-9. doi: 10.1111/j.1521-0391.2014.12131.x. Epub 2014 Sep 22.


Background: Some case series mention possible liver toxicity in opioid-dependent patients under buprenorphine treatment.

Methods: This 12-month prospective observational follow-up study in opioid-dependent patients under buprenorphine-naloxone treatment assessed outcome and safety issues. At baseline, 337 eligible datasets were available; 181 patients completed the 12-month study. Liver enzymes were tested at baseline and after 12, 24, and 52 weeks' treatment.

Results: One to two percent of patients showed mostly discrete elevations of liver enzymes, but no patient met the criteria for drug-induced liver injury. No serious liver-related adverse events occurred, but two non-serious cases of liver enzyme increase were recorded. No patient dropped out of treatment for liver-related disorders.

Conclusion: This study is in line with some recent studies and provides further evidence that buprenorphine-naloxone is relatively safe with respect to liver injury.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Alanine Transaminase / blood
  • Alkaline Phosphatase / blood
  • Aspartate Aminotransferases / blood
  • Buprenorphine / adverse effects*
  • Buprenorphine, Naloxone Drug Combination
  • Chemical and Drug Induced Liver Injury / blood
  • Chemical and Drug Induced Liver Injury / etiology*
  • Cohort Studies
  • Female
  • Humans
  • Male
  • Naloxone / adverse effects*
  • Narcotic Antagonists / adverse effects*
  • Opiate Substitution Treatment / adverse effects*
  • Opioid-Related Disorders / drug therapy*
  • Prospective Studies
  • gamma-Glutamyltransferase / blood


  • Buprenorphine, Naloxone Drug Combination
  • Narcotic Antagonists
  • Naloxone
  • Buprenorphine
  • gamma-Glutamyltransferase
  • Aspartate Aminotransferases
  • Alanine Transaminase
  • Alkaline Phosphatase