Adverse events with bismuth salts for Helicobacter pylori eradication: systematic review and meta-analysis

World J Gastroenterol. 2008 Dec 28;14(48):7361-70. doi: 10.3748/wjg.14.7361.


Aim: To assess the safety of bismuth used in Helicobacter pylori (H pylori) eradication therapy regimens.

Methods: We conducted a systematic review and meta-analysis. MEDLINE and EMBASE were searched (up to October 2007) to identify randomised controlled trials comparing bismuth with placebo or no treatment, or bismuth salts in combination with antibiotics as part of eradication therapy with the same dose and duration of antibiotics alone or, in combination, with acid suppression. Total numbers of adverse events were recorded. Data were pooled and expressed as relative risks with 95% confidence intervals (CI).

Results: We identified 35 randomised controlled trials containing 4763 patients. There were no serious adverse events occurring with bismuth therapy. There was no statistically significant difference detected in total adverse events with bismuth [relative risk (RR) = 1.01; 95% CI: 0.87-1.16], specific individual adverse events, with the exception of dark stools (RR = 5.06; 95% CI: 1.59-16.12), or adverse events leading to withdrawal of therapy (RR = 0.86; 95% CI: 0.54-1.37).

Conclusion: Bismuth for the treatment of H pylori is safe and well-tolerated. The only adverse event occurring significantly more commonly was dark stools.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't
  • Review
  • Systematic Review

MeSH terms

  • Anti-Bacterial Agents / therapeutic use
  • Bismuth / adverse effects*
  • Bismuth / therapeutic use*
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Helicobacter Infections / drug therapy*
  • Helicobacter pylori*
  • Humans
  • Randomized Controlled Trials as Topic


  • Anti-Bacterial Agents
  • Bismuth