Fruquintinib Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 22, 2024.

Applies to fruquintinib: oral capsule.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may harm your unborn baby if either partner is using it during conception or pregnancy. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 2 weeks after your last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 2 weeks after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause hypertension (high blood pressure). Check with your doctor right away if you have blurred vision, dizziness, headache, nervousness, pounding in the ears, or slow or fast heartbeat. Your doctor will check your blood pressure on a regular basis while you are using this medicine. You might need to monitor your blood pressure at home.

Check with your doctor right away if you have bleeding gums, coughing up blood, difficulty in breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, nosebleeds, paralysis, prolonged bleeding from cuts, red or dark brown urine, red or black, tarry stools, or trouble breathing. These may be symptoms of serious bleeding problems.

This medicine may increased risk of serious infections. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, body aches or pain, chest pain or tightness, chills, cough, difficult, burning, or painful urination, ear congestion, fever, frequent urge to urinate, headache, loss of voice, lower back or side pain, sneezing, sore throat, stuffy or runny nose, trouble breathing, or unusual tiredness or weakness.

This medicine can cause stomach or bowel perforation (tear or hole). Check with your doctor right away if you have severe stomach pain, constipation, fever, nausea, or vomiting.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause proteinuria (protein in the urine). Check with your doctor right away if you have cloudy urine or swelling of the face, hands, arms, legs, or feet.

This medicine may cause a serious skin problem called hand-foot syndrome or palmar-plantar erythrodysesthesia syndrome. Tell your doctor right away if you have a rash that does not go away or redness, pain, swelling, bleeding, or blisters on the palms of your hands or soles of your feet.

This medicine may increase your chance of having a brain condition, called posterior reversible encephalopathy syndrome (PRES). Check with your doctor right away if you start having chest pain, sudden and severe headaches, fainting spells, seizures, unusual drowsiness, confusion, or problems with vision, speech, or walking while you are taking this medicine.

This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine for at least 2 weeks before and after major surgery, or until adequate wound healing before taking this medicine again.

This medicine may increase your risk of developing blood clots. Check with your doctor right away if you have swelling and pain in your arms, legs, or stomach, chest pain, difficulty with breathing, loss of sensation, confusion, or problems with muscle control or speech.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of fruquintinib

Along with its needed effects, fruquintinib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fruquintinib:

Other side effects of fruquintinib

Some side effects of fruquintinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to fruquintinib: oral capsule.

General adverse events

The most common adverse reactions that occurred in 20% or more patients were hypertension, palmar-plantar erythrodysesthesia (PPE), proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (up to 61%), hemorrhage (up to 28%)
• Uncommon (0.1% to 1%): Arterial thromboembolic event^[Ref]

Dermatologic

• Very common (10% or more): PPE (up to 49%)
• Common (1% to 10%): Rash^[Ref]

Endocrine

• Very common (10% or more): Hypothyroidism (up to 21%)^[Ref]

Gastrointestinal

• Very common (10% or more): Stomatitis (up to 33%), abdominal pain (up to 29%), diarrhea (up to 25%)
• Common (1% to 10%): Proctalgia, gastrointestinal hemorrhage, gastrointestinal perforation or fistula, intestinal obstruction
• Frequency not reported: Vomiting^[Ref]

Hematologic

• Very common (10% or more): Decreased lymphocytes (up to 30%), decreased platelets (up to 30%), increased activated partial thromboplastin time (up to 21%), decreased hemoglobin (up to 23%)
• Uncommon (0.1% to 1%): Thrombotic microangiopathy^[Ref]

Hepatic

• Very common (10% or more): Increased AST (up to 42%), increased ALT (up to 34%)
• Frequency not reported: Hepatic function abnormalities, hepatic failure/encephalopathy^[Ref]

Metabolic

• Very common (10% or more): Anorexia (up to 21%), increased glucose (up to 43%), increased urate (up to 26%)^[Ref]

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (up to 22%), back pain (up to 15%) arthralgia (up to 13%)^[Ref]

Nervous system

• Uncommon (0.1% to 1%): Posterior reversible encephalopathy syndrome
• Frequency not reported: Cerebral infarction^[Ref]

Other

• Very common (10% or more): Fatigue (up to 53%), increased triglycerides (53%), increased cholesterol (37%), decreased albumin (up to 35%), decreased sodium (up to 35%), increased alkaline phosphatase (up to 40%), decreased magnesium (up to 20%), decreased calcium (up to 25%), decreased potassium (up to 22%)
• Uncommon (0.1% to 1%): Sepsis, septic shock
• Frequency not reported: Multiple organ dysfunction, bacterial infection, asthenia, wound dehiscence^[Ref]

Renal

• Very common (10% or more): Proteinuria (up to 55%), increased creatinine (up to 87%)
• Common (1% to 10%): Urinary tract infection, pneumonia^[Ref]

Respiratory

• Very common (10% or more): Dysphonia (up to 38%), throat pain (up to 10%)
• Common (1% to 10%): Epistaxis, upper respiratory tract infection
• Frequency not reported: Hemoptysis, lower respiratory infection^[Ref]

See also:

Further information

Fruquintinib side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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