Fruquintinib Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 27, 2024.

Applies to fruquintinib: oral capsule.

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:

More common side effects

• bleeding gums
• blurred vision
• cloudy urine
• constipation
• coughing up blood
• depressed mood
• dizziness
• dry skin and hair
• feeling cold
• hair loss
• headache
• hoarseness or husky voice
• increased menstrual flow or vaginal bleeding
• muscle cramps and stiffness
• nervousness
• nosebleeds
• paralysis
• pounding in the ears
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• redness, swelling, or pain of the skin
• scaling of the skin on the hands and feet
• slow or fast heartbeat
• tingling of the hands and feet
• trouble breathing
• ulceration of the skin
• unusual tiredness or weakness
• weight gain

Less common side effects

• bladder pain
• bloody or cloudy urine
• body aches or pain
• chest pain or tightness
• cough
• difficult, burning, or painful urination
• ear congestion
• fever or chills
• frequent urge to urinate
• heartburn
• indigestion
• lower back or side pain
• loss of voice
• severe stomach pain, cramping, or burning
• sneezing
• sore throat
• stuffy or runny nose
• vomiting of blood or material that looks like coffee grounds

Rare side effects

• agitation
• back pain
• coma
• confusion
• drowsiness
• hallucinations
• irritability
• mood or mental changes
• seizures
• stiff neck
• sudden weakness in the arms or legs

Incidence not known

• dark urine
• loss of appetite
• nausea or vomiting
• pains in the chest, groin, or legs, especially calves of the legs
• sudden loss of coordination
• sudden onset of slurred speech
• sudden vision changes
• yellow eyes or skin

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:

More common side effects

• diarrhea
• difficulty in moving
• joint pain
• muscle or bone pain
• swelling or inflammation of the mouth
• throat pain
• weight loss

Less common side effects

• pain in the rectum

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]

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.

Medical Disclaimer