Fulyzaq is an anti-diarrheal medication that is used in adults with HIV or AIDS (human immunodeficiency virus or acquired immunodeficiency syndrome).

Fulyzaq is used to treat diarrhea that is not caused by viral or bacterial infection (non-infectious). It is given to people who are taking antiviral medications to treat HIV or AIDS.

Fulyzaq is not a treatment for HIV or AIDS.

Fulyzaq may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Fulyzaq if you are allergic to crofelemer.

To make sure Fulyzaq is safe for you, tell your doctor if you are sick with diarrhea and vomiting or other symptoms of infection.

FDA pregnancy category C. It is not known whether Fulyzaq will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether crofelemer passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give Fulyzaq to anyone under 18 years old without medical advice.

Before you start treatment with Fulyzaq, your doctor may perform medical tests to make sure you do not have infectious diarrhea.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Fulyzaq with or without food.

Do not crush, chew, or break a delayed-release tablet. Swallow it whole.

Store at room temperature away from moisture and heat.

You should not use Fulyzaq if you are allergic to crofelemer.

To make sure Fulyzaq is safe for you, tell your doctor if you are sick with diarrhea and vomiting or other symptoms of infection.

FDA pregnancy category C. It is not known whether Fulyzaq will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether crofelemer passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give Fulyzaq to anyone under 18 years old without medical advice.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

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

• dark urine, jaundice (yellowing of the skin or eyes);

• wheezing, chest tightness, trouble breathing; or

• worsening diarrhea.

Common Fulyzaq side effects may include:

• bloating, gas; or

• cold symptoms such as stuffy nose, sneezing, cough.

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.