Risk of Serious Dehydration in Pediatric Patients
Linaclotide is contraindicated in patients less than 2 years of age; in nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration.
Patient counseling
Medical guidelines
Package inserts
Keywords: Linzess
Updated: September 2021
Disclaimer: This information presents a SUMMARY of Black Box data from product information labeling and does not address additional warnings, precautions, or other important safety data in the product insert. Patient care decisions SHOULD NOT be made without reviewing the most recent product information insert, which may be obtained from the manufacturer. This table may not be complete as it was prepared using product information from package inserts. It is periodically updated with supplemental information from FDA safety alerts, the FDA labeling announcements, and new drug approvals.
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