Important Safety Information | Prescribing Information (PDF)

Fulyzaq™ is Now Approved by the FDA for Symptomatic Relief of Non-infectious Diarrhea in Patients With HIV/AIDS on Anti-retroviral Therapy.

Sign Up Today

Be among the first to receive information about Fulyzaq as it becomes available.

  • = required.
  • Enter at least 2 alpha characters.
  • Enter at least 2 alpha characters.
  • Enter a valid email address.
  • Confirm the email address.
  • Select an option from the menu.
  • Select an option from the menu.
  • Enter at least 2 alphanumeric characters.

  • I certify that I am 18 years of age or older and a resident of the United States.

    Required.

  • Yes! I am also interested in receiving additional communications (health tips, wellness tools, coupons, other discounts, educational materials, product information, etc) from Salix Pharmaceuticals.

  • All personal information will be kept confidential and will not be shared with any parties other than Salix Pharmaceuticals and its designated partners. View our full Privacy Policy.

Indication

FULYZAQTM is an anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy.

Important Safety Information about Fulyzaq

FULYZAQTM (crofelemer) delayed-release tablets should not be used for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting FULYZAQ. If infectious etiologies are not considered, and FULYZAQ is initiated based on a presumptive diagnosis of non-infectious diarrhea, then there is a risk that patients with infectious etiologies will not receive the appropriate treatments, and their disease may worsen.

Based on animal data, FULYZAQ may cause fetal harm. Safety and effectiveness of FULYZAQ have not been established in patients less than 18 years of age.

In clinical studies, the most common adverse reactions (occurring in ≥ 3% patients and at a rate greater than placebo) were upper respiratory tract infection, bronchitis, cough, flatulence and increased bilirubin.

Salix obtained rights to crofelemer under license from Napo Pharmaceuticals, Inc.

Please see complete Prescribing Information for FULYZAQ.PDF