Safety and tolerability of rifaximin for the treatment of irritable bowel syndrome without constipation: a pooled analysis of randomised, double‐blind, placebo‐controlled trials
Open accessAbstract
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).
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A pooled analysis by Schoenfeld et al confirmed the safety and tolerability profile of rifaximin in comparison with placebo, with similar incidence of drug-related adverse events.
“a pooled analysis by Schoenfeld et al [292] has confirmed the safety and tolerability profile of rifaximin in comparison with placebo, with similar incidence of drug-related adverse events”
From Gut microbiota role in irritable bowel syndrome: New therapeutic strategies (2016) · cites this paper as [292]
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- Authors
- Schoenfeld, P., Pimentel, M., Chang, L., Lembo, A., Chey, W. D., Yu, J., Paterson, C., Bortey, E., & Forbes, W. P.
- Affiliations
- University of Michigan (US)
- Cedars-Sinai Medical Center (US)
- University of California, Los Angeles (US)
- Beth Israel Deaconess Medical Center (US)
- Salix Pharmaceuticals (United States) (US)
- Corresponding author
- Schoenfeld, P.
- Venue
- Alimentary Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2014-04-03
- Volume
- 39
- Issue
- 10
- Pages
- 1161-1168
- ISSN
- 0269-2813 (ISSN-L)
- 1365-2036
- PMC
- PMC4112801
- OpenAlex
- W2061365505
- Cited by
- 106
- References
- 29
- Citations by year
- 2026: 5 · 2025: 5 · 2024: 5 · 2023: 3 · 2022: 9 · 2021: 12 · 2020: 4 · 2019: 7 · 2018: 16 · 2017: 2 · 2016: 19 · 2015: 13 · 2014: 5 · 2012: 1
- FWCI
- 13.05
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Alimentary Pharmacology & Therapeutics (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Deep Blue (University of Michigan) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by-nc-nd)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Keywords
- rifaximin, drug safety, tolerability, adverse events, gastrointestinal adverse effects, infection-related adverse events, Clostridium difficile colitis, antibiotic resistance, post-treatment follow-up
- MeSH terms
- Rifaximin, Adolescent, Adult, Aged, Aged, 80 and over, Anti-Bacterial Agents, Double-Blind Method, Female, Follow-Up Studies, Gastrointestinal Agents, Humans, Male, Middle Aged, Rifamycins, Randomized Controlled Trials as Topic, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic, Irritable Bowel Syndrome, Young Adult
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