warnings

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

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

severe constipation or a blockage in your intestines;
a history of gallbladder obstruction, or if your gallbladder has been removed;
digestive problems caused by a muscle valve called the sphincter of Oddi (SFINK-ter of OD-dee);
severe liver disease;
a pancreas disorder; or
a habit of drinking more than 3 alcoholic beverages per day.

Tell your doctor if you have ever had:

liver disease; or
kidney disease (or if you are on dialysis).

Tell your doctor if you are pregnant or breastfeeding.

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

Side Effects

What are the side effects of Eluxadoline (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 taking eluxadoline and call your doctor at once if you have:

new or worsening stomach pain (may be severe);
nausea and vomiting;
severe constipation;
constipation lasting longer than 4 days; or
severe pain in your upper stomach spreading to your back.

Side effects may be more likely in older adults.

Common side effects may include:

constipation;
nausea; or
stomach pain.

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 Eluxadoline (Oral)?

Use Eluxadoline (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. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Eluxadoline may be habit-forming. Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Take with food.

Eluxadoline may cause pancreatitis or constipation, which could be severe or lead to hospitalization. Call your doctor at once if you have severe or ongoing constipation, severe pain in your upper stomach spreading to your back (with or without nausea and vomiting).

Store at room temperature away from moisture and heat.

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

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.