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Summary   Background  The efficacy of rifaximin, a nonsystemic, gut‐targeted antibiotic for reducing non–constipation‐predominant irritable bowel syndrome (non‐C  IBS ) symptoms, has been demonstrated in one phase 2b and two phase 3 randomised, double‐blind, placebo‐controlled trials, but detailed data about rifaximin safety and tolerability during treatment and subsequent follow‐up periods are lacking.    Aim  To assess and determine the frequency of rifaximin and placebo adverse events ( AE s) in phase 2b and phase 3 non ‐ C  IBS  trials.    Methods  A  post hoc  pooled safety analysis of the phase 2b (rifaximin 275, 550, and 1100 mg twice daily for 2 weeks; 550 mg twice daily for 4 weeks) and phase 3 (rifaximin 550 mg three times daily for 2 weeks) studies was performed. Data on treatment and post‐treatment  AE s were collected. Patients were followed up for 12 weeks and 10 weeks post‐treatment in the phase 2b and phase 3 trials, respectively.    Results  Patients receiving rifaximin ( n  =   1103) and placebo ( n  =   829) had a similar incidence of drug‐related  AE s (12.1% vs. 10.7%), serious  AE s (1.5% vs. 2.2%), drug‐related  AE s resulting in study discontinuation (0.8% vs. 0.8%), gastrointestinal‐associated  AE s (12.2% vs. 12.2%) and infection‐associated  AE s (8.5% vs. 9.5%). There were no cases of  Clostridium difficile  colitis or deaths.    Conclusions  The safety and tolerability profile of rifaximin during treatment and post‐treatment was comparable to placebo. Future research should define the safety and tolerability profile, including risk of  C. difficile  colitis and microbial antibiotic resistance, with repeated courses of rifaximin in patients with non—constipation‐predominant irritable bowel syndrome (ClinicalTrials.gov:  NCT 00269412,  NCT 00731679, and  NCT 00724126).

alimentary pharmacology and therapeutics

Safety and tolerability of rifaximin for the treatment of irritable bowel syndrome without constipation: a pooled analysis of randomised, double‐blind, placebo‐controlled trials