Important Risk Information
Do not give LINZESS to children who are less than 6 years of age. It may harm them.
LINZESS can cause severe diarrhea and your child could get severe dehydration (loss
of a large amount of body water and salt).
You should not give LINZESS to children 6 years to less than 18 years of age. It may
Do not take LINZESS if a doctor has told you that you have a bowel blockage
Before you take LINZESS, tell your doctor about your medical conditions, including if you are:
Pregnant or plan to become pregnant. It is not known if LINZESS will harm
your unborn baby.
Breastfeeding or plan to breastfeed. It is not known if LINZESS passes into
your breast milk.
Tell your doctor about all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.
LINZESS can cause serious side effects, including diarrhea, the most common side effect,
which can sometimes be severe.
Diarrhea often begins within the first 2 weeks of LINZESS treatment.
Stop taking LINZESS and call your doctor right away if you get severe diarrhea during treatment with LINZESS.
Other common side effects of LINZESS include gas, stomach-area (abdominal) pain, swelling, or a feeling of
fullness or pressure in your abdomen (distension).
Call your doctor or go to the nearest hospital emergency room right away if you develop unusual or
severe stomach-area (abdominal) 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. For more information, ask your doctor or pharmacist.
What is LINZESS?
LINZESS® (linaclotide) is a prescription medication used in adults to treat
irritable bowel syndrome with constipation (IBS‑C) and chronic idiopathic constipation (CIC).
"Idiopathic" means the cause of the constipation is unknown.
It is not known if LINZESS is safe and effective in children less than 18 years of age.
Please also see
full Prescribing Information.