Safety and tolerability of the antibacterial rifaximin in the treatment of travellers' diarrhoea

Drug Saf. 2006;29(3):201-7. doi: 10.2165/00002018-200629030-00004.


Although travellers' diarrhoea can sometimes be associated with postinfectious complications, the condition is typically self-limiting. The infectious-diarrhoea guidelines subcommittees of the Infectious Disease Society of America and the American College of Gastroenterology recommend empirical antibacterial therapy for travellers' diarrhoea. Because therapy is directed largely at relieving symptoms and minimising inconvenience, the chosen antibacterial should ideally be both efficacious and pose a low risk of adverse effects. This review discusses the safety and tolerability of rifaximin in the treatment of travellers' diarrhoea, with a focus on data from controlled clinical trials. Data were obtained from a MEDLINE search using the key word 'rifaximin' with no date limits and from the rifaximin New Drug Application submitted to the US FDA for approval to market rifaximin in the US.Currently, the antibacterials considered as standard treatment for travellers' diarrhoea are systemically absorbed, carry defined risks of adverse effects, and have many uses other than the treatment of enteric disease. The minimally absorbed (<0.4%) oral antibacterial rifaximin constitutes a non-systemic approach to antidiarrhoeal therapy that should overcome some of the limitations of current antibacterials used for travellers' diarrhoea. Rifaximin is differentiated from these, and most other antibacterials, by having a tolerability profile comparable with that of placebo and minimal potential for drug interactions. To date, clinically relevant resistance to rifaximin has not been observed. As the first nonabsorbable antibacterial to be marketed for travellers' diarrhoea, rifaximin should help to change the management paradigm for travellers' diarrhoea and other gastrointestinal illnesses from a systemic approach to a predictably safer, non-systemic approach.

Publication types

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

MeSH terms

  • Anti-Infective Agents* / adverse effects
  • Anti-Infective Agents* / pharmacology
  • Anti-Infective Agents* / therapeutic use
  • Clinical Trials as Topic
  • Diarrhea / drug therapy*
  • Gastrointestinal Agents* / adverse effects
  • Gastrointestinal Agents* / pharmacology
  • Gastrointestinal Agents* / therapeutic use
  • Humans
  • Rifamycins* / adverse effects
  • Rifamycins* / pharmacology
  • Rifamycins* / therapeutic use
  • Rifaximin
  • Travel*


  • Anti-Infective Agents
  • Gastrointestinal Agents
  • Rifamycins
  • Rifaximin