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
Updated December 2019