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 harm them.
- Do not take LINZESS if a doctor has told you that you have a bowel blockage (intestinal
obstruction).
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.
Side Effects
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 Medication Guide
within Full Prescribing Information.