Brigatinib Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Oct 14, 2023.

Applies to brigatinib: oral tablet.

Serious side effects of Brigatinib

Along with its needed effects, brigatinib 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 brigatinib:

More common

• Back pain
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or tightness
• chills
• clay colored stools
• confusion
• cough
• dark urine
• decreased appetite
• difficulty in moving
• dizziness
• dry mouth
• fever
• flushed, dry skin
• fruit-like breath odor
• headache
• hoarseness
• increased hunger
• increased thirst
• increased urination
• itching, skin rash
• joint pain
• loss of appetite
• lower back or side pain
• muscle pain, tenderness, or weakness
• nausea
• nervousness
• pain in the arms or legs
• painful or difficult urination
• pale skin
• pounding in the ears
• skin rash or itching
• slow or fast heartbeat
• sneezing
• sore throat
• stomach pain or tenderness
• sweating
• swelling of the feet or lower legs
• swollen joints
• thickening of bronchial secretions
• trouble breathing
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• weakness in the arms, hands, legs, or feet
• yellow eyes or skin

Less common

• Anxiety
• general feeling of discomfort or illness
• increased sensitivity of the skin to sunlight
• redness or other discoloration of the skin
• severe sunburn
• thickening of bronchial secretions

Rare

• Fast heartbeat

Other side effects of Brigatinib

Some side effects of brigatinib 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

• Diarrhea
• difficulty having a bowel movement
• ear congestion
• loss of voice
• stuffy or runny nose
• swelling or inflammation of the mouth
• trouble sleeping
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

Less common

• Change in taste
• loss of taste

For Healthcare Professionals

Applies to brigatinib: oral tablet.

General

-The most common adverse reactions (25% or more) were nausea, diarrhea, fatigue, cough, and headache.

-Serious adverse reactions occurred in 38% to 40% of patients; fatal cases were reported in 3.7% of patients and consisted of pneumonia (2 patients), sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis, and urosepsis (1 patient each).^[Ref]

Hepatic

Very common (10% or more): Increased AST (65%), increased ALT (40%), increased alkaline phosphatase (29%)^[Ref]

Endocrine

Very common (10% or more): Hyperglycemia (49%)^[Ref]

Musculoskeletal

Very common (10% or more): Increased creatine phosphokinase (48%), muscle spasms (17%), back pain (15%), myalgia/musculoskeletal pain (15%), arthralgia (14%), pain in extremity (11%)^[Ref]

Gastrointestinal

Very common (10% or more): Increased lipase (45%), nausea (40%), increased amylase (39%), diarrhea (38%), vomiting (24%), constipation (19%), abdominal pain and distension/epigastric discomfort (17%)^[Ref]

Hematologic

Very common (10% or more): Anemia (40%), lymphopenia (27%)^[Ref]

Other

Very common (10% or more): Fatigue/asthenia (36%), pyrexia (14%)^[Ref]

Respiratory

Very common (10% or more): Cough (34%), dyspnea/exertional dyspnea (27%)

Common (1% to 10%): interstitial lung disease/pneumonitis, hypoxia^[Ref]

Nervous system

Very common (10% or more): Headache/sinus headache (28%), peripheral sensory neuropathy/paresthesia (13%)^[Ref]

Dermatologic

Very common (10% or more): Rash (exfoliative, pruritic, pustular)/acneiform dermatitis (24%)

Common (1% to 10%): Photosensitivity^[Ref]

Metabolic

Very common (10% or more): Decreased phosphorous (23%), decreased appetite (22%)^[Ref]

Cardiovascular

Very common (10% or more): Prolonged activated partial thromboplastin time (22%), hypertension (21%)

Common (1% to 10%): Bradycardia^[Ref]

Psychiatric

Very common (10% or more): Insomnia (11%)^[Ref]

Ocular

Very common (10% or more): Visual disturbance (10%), pneumonia (10%)^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer