diagnosis

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The majority of IBS-D patients suffer with multiple symptoms1

Make a symptom-based diagnosis within your office2

Undiagnosed in

%
of patients5

Irritable bowel syndrome with diarrhea (IBS-D) affects approximately 7.2 million adults in the US.3,4 Diagnosis is based on clinical history, symptoms, physical examination, limited diagnostic testing, and exclusion of alarm features.2 In fact, the American College of Gastroenterology does not recommend routine diagnostic testing in patients when symptom-based criteria are fulfilled and alarm features are not present.5

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Dr. Pimentel discuss the diagnostic criteria for patients with IBS-D.

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Encourage your patients to take the time to talk about their IBS-D symptoms

IBS-D can be diagnosed in adults based on symptoms alone2

Icon history

Evaluate patient history based on Rome V criteria for IBS-D2

  • Recurrent but not continuous abdominal pain or discomfort on average at least 3 days per month in the last 3 months associated with 2 or more of the following*: . Defecation . Change in stool frequency . Change in stool form . <25% hard lumpy stool, >25% loose watery stool

    *Abdominal pain/discomfort should not only be related to menses. With symptom onset at least 6 months prior to diagnosis.2

Icon alarm

Exclude alarm features2

  • Anemia
  • Rectal bleeding
  • Unexpected weight loss
  • Nocturnal diarrhea
  • Symptom onset after 50
  • Fecal incontinence
  • Family history of colorectal cancer, IBD, or celiac disease
Icon physical

Use physical exam and limited diagnostic testing2

In a secondary-care study of patients referred with IBS,

93.5%

who met Rome V Criteria were clinically diagnosed with IBS6†

†Population sample of 745 patients using Rome V Diagnostic Questionnaires.6

XIFAXAN Patient Brochure

Inform your patients with IBS-D about XIFAXAN

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Use the 25% Rule to determine IBS-D type2

On days with at least one abnormal bowel movement2

  • <25% of bowel movements with hard, lumpy stool (type 1 or 2 on the Bristol Stool Form Scale)
  • >25% of bowel movements with loose, watery stool (type 6 or 7 on the Bristol Stool Form Scale)
BSS chart

The Bristol Stool Form Scale has been shown to be a reliable surrogate marker for colonic transit. Copyright Rome Foundation, Bristol Stool Form Scale developed by Dr. Ken Heaton, University of Bristol, UK

Rome V reinforces a positive diagnostic approach2

With 10 years since its last revision, Rome V guidelines streamline the process of diagnosing IBS-D. These updates aim to reduce unnecessary diagnostic testing and empower clinicians to make diagnoses based on symptoms alone.

Diagnostic Criteria

Rome V specifies that pain does not need to be continuous, adds discomfort as a criteria, and relaxes symptom recurrence from 1 day/week to 3 days/month.* Rome V also advises on ruling out menstrual pain/discomfort.2,†

Bothersomeness

If symptoms impact the patient enough to seek medical care, diagnosis can be made with a lower frequency and shorter duration (8 weeks or more) instead of 3 months.2,7,‡

Key Takeaways

While Rome IV criteria were originally geared toward clinical-trial settings, Rome V is focused on less restrictive real-world applications. Rome V criteria alleviate diagnostic barriers for patients with less severe symptoms, and increase the prevalence of patients meeting IBS diagnostic criteria.2,7,8

Bothersomeness

If symptoms impact the patient enough to seek medical care, diagnosis can be made with a lower frequency and shorter duration (8 weeks or more) instead of 3 months.2,7,‡

Key Takeaways

While Rome IV criteria were originally geared toward clinical-trial settings, Rome V is focused on less restrictive real-world applications. Rome V criteria alleviate diagnostic barriers for patients with less severe symptoms, and increase the prevalence of patients meeting IBS diagnostic criteria.2,7,8

*Provided there is clinical confidence that other diagnoses have been sufficiently ruled out based on presentation and additional investigations as needed.7

†With symptom onset at least 6 months prior to diagnosis.2

‡Exceptions are when a clinician needs to make an earlier diagnosis and is satisfied that the medical evaluation excludes other disease or for diagnoses where the symptoms occur infrequently and intermittently.7

IBD, irritable bowel disease; IBS irritable bowel syndrome.

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INDICATIONS

XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

XIFAXAN® (rifaximin) 550 mg tablets are indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

IMPORTANT SAFETY INFORMATION

  • XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
  • Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
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INDICATIONS

XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

IMPORTANT SAFETY INFORMATION

  • XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
  • Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
  • There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients.
  • Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin.
  • In clinical studies, the most common adverse reactions for XIFAXAN (alone or in combination with lactulose) were:
    – HE (≥10%): Peripheral edema (17%), constipation (16%), nausea (15%), fatigue (14%), insomnia (14%), ascites (13%), dizziness (13%), urinary tract infection (12%), anemia (10%), and pruritus (10%)
    – IBS-D (≥2%): Nausea (3%), ALT increased (2%)
  • INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
  • XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information.

References: 1. American Gastroenterological Association. IBS in America: survey summary findings. December 2015. Accessed January 4, 2024. http://www.multivu.com/players/English/7634451-aga-ibs-in-america-survey/docs/survey-findings-pdf-635473172.pdf 2. Corsetti M, Shin A, Lacy B, et al. Bowel Disorders. Gastroenterology. 2026;170:1261-1282. doi:10.1053/j.gastro.2026.02.003 3. Almario CV, Choi SY, Chey WD, et al. Trends in Prevalence of Rome IV Disorders of Gut-Brain Interaction During the COVID-19 Pandemic: Results From a Nationally Representative Sample of Over 160,000 People in the US. Neurogastroenterol Motil. 2026;38(4):e70020. doi:10.1111/nmo.70020 4. US Census Bureau. National Demographic Analysis Tables: 2020. Table 3: Middle Series Estimates of the U.S. Resident Population and Components Used to Construct the Population by Age: April 1, 2020. Accessed February 1, 2023. 5. Ford AC, Moayyedi P, Lacy BE, et al; Task Force on the Management of Functional Bowel Disorders. American College of Gastroenterology monograph on the management of irritable bowel syndrome and chronic idiopathic constipation. Am J Gastroenterol. 2014;109(suppl 1):S2-S26. 6. Staller K, Goodory VC, Khasawnek M, et al. The Rome V criteria for the diagnosis of irritable bowel syndrome in secondary care: a diagnostic accuracy study. Lancet Gastroenterol Hepatol. 2026;11:812-20. https://doi.org/10.1016/S2468-1253(26)00118-4 7. Drossman DA, Chang L, Tack J, et al. Disorders of the Gut-Brain interaction and the Rome V process. Gastroenterology. 2026;170(6):1083-1089. 8. Palsson OS, Whitehead W, Törnblom H, Sperber AD, Simren M. Prevalence of Rome IV functional bowel disorders among adults in the United States, Canada, and the United Kingdom. Gastroenterology. 2020;158(5):1262-1273.e3. 9. Pimentel M, Lembo A, Chey WD, et al. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011;364(1):22-32. 10. Zhong W, Lu X, Shi H, et al. Distinct Microbial Populations Exist in the Mucosa-associated Microbiota of Diarrhea Predominant Irritable Bowel Syndrome and Ulcerative Colitis. J Clin Gastroenterol. 2019;53(9):660-672. 11. Sundin J, Aziz I, Nordlander S, et al. Evidence of altered mucosa-associated and fecal microbiota composition in patients with Irritable Bowel Syndrome. Nature News. January 17, 2020. Accessed January 4, 2024.

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