warnings

What is the most important information I should know about Linaclotide (Oral)?

You should not use linaclotide if you are allergic to it, or if you have:

a blockage in your intestines (bowel obstruction).

Linaclotide is not approved for use by anyone younger than 18 years old.

Linaclotide should not be given to a child younger than 6 years old. Linaclotide can cause severe diarrhea and fatal dehydration in a child. Do not give this medicine to any child or teenager without the advice of a doctor.

Tell your doctor if you are pregnant or breastfeeding.

Side Effects

What are the side effects of Linaclotide (Oral)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using linaclotide and call your doctor at once if you have:

severe or ongoing diarrhea; or
diarrhea with dizziness or a light-headed feeling (like you might pass out).

Common side effects may include:

diarrhea;
stomach pain;
gas; or
bloating or full feeling in your stomach.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dosage Guidelines & Tips

How to take Linaclotide (Oral)?

Use Linaclotide (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take linaclotide in the morning on an empty stomach, at least 30 minutes before your first meal.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce or bottled water. Swallow the mixture right away without chewing. Do not save it for later use.

Even if you have taken this medicine with applesauce, wait at least 30 minutes before eating a full meal.

If needed, medicine from the linaclotide capsule may be given through a nasogastric (NG) or gastronomy tube.

Carefully follow instructions for mixing medicine from the capsule with applesauce or water, or giving the medicine through a feeding tube. Ask your doctor or pharmacist if you have any questions.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Keep this medicine out of the reach of children. Linaclotide can be fatal to a child who accidentally swallows this medicine. Seek emergency medical attention if this happens.

What should I do if I missed a dose of Linaclotide (Oral)?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.