Fruquintinib is used in adults to treat colorectal cancer. This medicine is used when the cancer has spread to other parts of the body (metastatic).

Fruquintinib is given after other treatments did not work or stopped working.

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

Tell your doctor if you have or have ever had:

• an active or recent infection;
• an allergy to aspirin or food dye (tartrazine or sunset yellow fcf);
• a perforation (a hole or tear) in your stomach or intestines;
• bleeding problems, or a wound that has not healed;
• a recent surgery or have a planned surgery within the next 2 weeks;
• a heart attack, stroke, or blood clot;
• high blood pressure; or
• liver or kidney disease.

Fruquintinib can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 2 weeks after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 2 weeks after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Use Fruzaqla (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.

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

Some people taking fruquintinib have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the stomach or intestines. Call your doctor if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.

Get emergency medical help if you have signs of a heart attack, blood clot, or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, or feeling short of breath.

Also call your doctor at once if you have:

• severe headache, pounding in your neck or ears;
• a light-headed feeling, like you might pass out;
• increased urination, swelling in your ankles or feet;
• confusion, thinking problems, vision problems, seizure;
• loss of balance or coordination;
• redness, rash, or blisters on the palms of your hands or the soles of your feet;
• any wound that will not heal;
• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, trouble breathing or cough;
• unusual bleeding--easy bruising, nosebleeds, bleeding gums, abnormal vaginal bleeding, heavy menstrual bleeding, any bleeding that will not stop;
• bleeding inside your body--weakness, dizziness, pink or brown urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• changes in your voice or hoarseness;
• stomach pain, diarrhea; or
• feeling weak or tired.

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.

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