Diarrhea Diarrhea Was The Most Common Adverse Reaction Of Linzess-treated Patients In The Pooled Ibs-c And Cic Double-blind Placebo-controlled Trials.
Use of LINZESS should be avoided in pediatric patients 6 through 17 years of age. Although there were no deaths in older juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and efficacy data in pediatric patients, use of LINZESS should be avoided in pediatric patients 6 through 17 years of age. Diarrhea Diarrhea was the most common adverse reaction of LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. Severe diarrhea was reported in 2% of LINZESS-treated patients. The incidence of diarrhea was similar in the IBS-C and CIC populations. Patients should be instructed to stop LINZESS if severe diarrhea occurs and to contact their healthcare provider. The healthcare provider should consider dose suspension and rehydration. Adverse Reactions In IBS-C clinical trials, the most common adverse reactions in LINZESS-treated patients (incidence 2% and greater than placebo) were diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%). In CIC clinical trials, the most common adverse reactions in LINZESS-treated patients (incidence 2% and greater than placebo) were diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%). Please see full Prescribing Information including Boxed Warning: http://www.frx.com/pi/linzess_pi.pdf .
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