No black box warning on record for Linzess

As of the latest FDA labeling reviewed, Linzess (LINACLOTIDE) does not carry a black box warning. Standard warnings and precautions still apply — see the full Linzess medicine page for the complete safety profile.

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Diarrhea: Patients may experience severe diarrhea. If severe diarrhea occurs, suspend dosing and rehydrate the patient. ( 5.2 ) 5.1 Risk of Serious Dehydration in Pediatric Patients Less Than 2 Years of Age LINZESS is contraindicated in patients less than 2 years of age. In neonatal mice (human age equivalent of approximately 0 to 28 days), linaclotide increased fluid se

No black box warning on record for Linzess

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Diarrhea: Patients may experience severe diarrhea. If severe diarrhea occurs, suspend dosing and rehydrate the patient. ( 5.2 ) 5.1 Risk of Serious Dehydration in Pediatric Patients Less Than 2 Years of Age LINZESS is contraindicated in patients less than 2 years of age. In neonatal mice (human age equivalent of approximately 0 to 28 days), linaclotide increased fluid se

Linzess Black Box Warning

No black box warning on record for Linzess

Other warnings & precautions

Linzess Black Box Warning

No black box warning on record for Linzess

Other warnings & precautions