Diarrheaĭiarrhea was the most commonly reported adverse reaction of the LINZESS-treated patients in the pooled IBS-C pivotal placebo-controlled trials.
Linzess 145 mcg capsule trial#
Table 1: Most Common Adverse Reactions a in Two Placebo-Controlled Trials (1 and 2) in Patients with IBS-C Adverse ReactionsĪ: Reported in at least 2% of LINZESS-treated patients and at an incidence greater than placeboī: “Abdominal pain” term includes abdominal pain, upper abdominal pain, and lower abdominal pain.Īdverse reactions in an additional placebo-controlled trial in 614 IBS-C patients randomized to placebo or LINZESS 290 mcg once daily on an empty stomach for 12 weeks (Trial 6) were similar to those in Table 1. Table 1 provides the incidence of adverse reactions reported in at least 2% of IBS-C patients in the LINZESS treatment group and at an incidence that was greater than in the placebo group. Patients were randomized to receive placebo or 290 mcg LINZESS once daily on an empty stomach for up to 26 weeks. The data described below reflect exposure to LINZESS in the two placebo-controlled clinical trials involving 1605 adult patients with IBS-C (Trials 1 and 2). Irritable Bowel Syndrome With Constipation (IBS-C) Most Common Adverse Reactions You may report side effects to FDA at 1-80.īecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.Įxposure in clinical development included approximately 2570, 2040, and 1220 patients with either IBS-C or CIC treated with LINZESS for 6 months or longer, 1 year or longer, and 18 months or longer, respectively (not mutually exclusive).ĭemographic characteristics were comparable between treatment groups in all studies.
Call your doctor for medical advice about side effects. This is not a complete list of side effects and others may occur. Our Linzess (linaclotide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Consult your doctor before breastfeeding. Caution should be exercised when Linzess is administered to nursing women. Linzess should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Linzess During Pregnancy and Breastfeeding Tell your doctor all medications you use. What Drugs, Substances, or Supplements Interact with Linzess? Pediatric patients under the age of 17 should not take Linzess. The same applies for those with chronic idiopathic constipation only the dosage is 145 mcg. The recommended dose of Linzess for those with irritable bowel syndrome (IBS) is 290 mcg taken once a day on an empty stomach, at least 30 minutes before the first meal of the day. cold symptoms such as stuffy nose, sneezing, or sinus pain.Linzess (linaclotide) is a guanylate cyclase-C agonist used to treat irritable bowel syndrome with constipation ( IBS-C) and chronic idiopathic constipation ( CIC) in adults.
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