Tenapanor

Risk of Serious Dehydration in Pediatric Patients

• IBSRELA is contraindicated in patients less than 6 years of age; in young juvenile rats, tenapanor caused death presumed to be due to dehydration. 
• Avoid use of IBSRELA in patients 6 years to less than 12 years of age. 
• The safety and effectiveness of IBSRELA have not been established in pediatric patients less than 18 years of age. 

Patient Counseling Information

• IBSRELA

Medication Guides

Patient Medication Guide - IBSRELA

Package Inserts

Tenapanor