How often does diarrhea occur with Linzess?

In studies with Linzess, the number of people who experienced diarrhea differed based on why they were receiving Linzess and the dose they were taking. In general, diarrhea may occur in up to 20% of patients taking Linzess, may be more frequent with higher doses and some patients may need to stop treatment due to this side effect.

Diarrhea, which can be severe in some people, is the most common side effect of Linzess. Diarrhea often begins within the first 2 weeks of starting treatment. Stop the medicine and call your doctor right away if you experience severe diarrhea during treatment.

Irritable bowel syndrome with constipation (IBS-C)

• In adults with IBS-C taking 290 mcg of Linzess once daily on an empty stomach for up to 26 weeks, diarrhea was reported in 20% of patients, compared to 3% of those receiving a placebo (inactive) treatment.
• Severe diarrhea was reported in 2% of those taking Linzess vs. 1% in the group receiving a placebo.
• Five percent of Linzess-treated patients stopped treatment due to diarrhea vs. less than 1% in the placebo group.

Chronic idiopathic constipation (CIC)

• In adults with CIC taking Linzess 145 mcg of Linzess once daily on an empty stomach for at least 12 weeks, diarrhea was reported in 16% of patients, compared to 5% of those receiving a placebo (inactive) treatment.
• In another 12-week in adults with CIC taking Linzess 72 mcg of Linzess once daily on an empty stomach, diarrhea was reported in 19% of patients, compared to 7% of those receiving a placebo.
• Severe diarrhea was reported in less than 1% of those taking the 72 mcg dose and in 2% of the group receiving the 145 mcg dose, vs. less than 1% of the placebo-treated patients.
• Two percent of Linzess-treated patients using the 72 mcg stopped treatment due to diarrhea vs. less than 1% in the placebo group.
• In patients treated with 145 mcg Linzess, the most common reasons for discontinuation due to adverse reactions were diarrhea (3% to 5%) and abdominal (stomach area) pain (1%) vs. less than 1% of patients in the placebo group.

Functional constipation (FC) in children and adolescents 6 to 17 years of age

• In a 12-week study in children 6 to 17 years of age with FC taking 72 mcg of Linzess once daily on an empty stomach, diarrhea was reported in 4% of patients receiving Linzess compared to 2% of those taking a placebo (inactive) treatment.
• One case of severe diarrhea was reported in the Linzess group and this patient stopped treatment. No patient in the placebo-treated group discontinued treatment due to severe diarrhea.

Other common side effects include:

• gas
• stomach-area (abdomen) pain
• swelling, or a feeling of fullness or pressure in your abdomen (distention).

Call your doctor or go to the nearest hospital emergency room right away if you develop unusual or severe stomach-area (abdomen) pain, especially if you also have bright red, bloody stools or black stools that look like tar.

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How soon does diarrhea start with Linzess?

Diarrhea, which can be severe, is the most common side effect of Linzess. Diarrhea often begins within the first 2 weeks of starting treatment. Stop the medicine and call your doctor right away if you get severe diarrhea during treatment.

In studies, some people stopped treatment due to diarrhea or other stomach side effects. Diarrhea appears to be dose-related, which means that diarrhea may be reported more frequently in people who take higher doses of Linzess.

Call your doctor or go to the nearest hospital emergency room right away if you develop unusual or severe stomach-area (abdomen) pain, especially if you also have bright red, bloody stools or black stools that look like tar.

These are not all the possible side effects of Linzess.

• To learn more, see: Linzess side effects (in more detail).

This is not all the information you need to know about Linzess (linaclotide) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.