Important Safety Information
XIFAXAN (rifaximin) 550 mg tablets are approved to reduce the risk of overt hepatic encephalopathy (HE) recurrence in people 18 and older. In a scientific study of XIFAXAN for HE, 91% of patients were also taking lactulose. XIFAXAN has not been studied in people with MELD scores >25, and only 8.6% of people in the controlled study had MELD scores over 19. There is an increased chance that XIFAXAN will spread through your body if you have more severe hepatic dysfunction. Therefore, if you have severe hepatic impairment, which is a Child-Pugh score of C, you should exercise caution when taking XIFAXAN.
XIFAXAN is not for everyone. Do not take XIFAXAN if you have a known hypersensitivity to rifaximin or any of the components in XIFAXAN.
XIFAXAN, like nearly all antibiotics, can alter the normal flora of the colon. This can lead to an overgrowth of Clostridium difficile (C. difficile) bacteria. If you take XIFAXAN, there is a chance you could experience diarrhea caused by C. difficile. C. difficile can cause symptoms ranging in severity from mild diarrhea to life-threatening inflammation of the colon. If you suspect you have C. difficile–associated diarrhea, contact your healthcare provider immediately, as treatment may need to be discontinued.
The most common side effects associated with XIFAXAN—occurring in more than 8% of people—were edema peripheral, nausea, dizziness, fatigue, ascites, muscle spasms, pruritus, and abdominal pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Xifaxan550 is not available for sale outside the U.S.
Xifaxan550 is licensed by Alfa Wassermann S.p.A. to Salix Pharmaceuticals, Inc.
Complete Prescribing Information
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: Salix@medcomsol.com