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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

Medication Guides

Patient Medication Guide - IBSRELA

Package Inserts

Tenapanor

Updated December 2019