Brigatinib Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 14, 2025.

Applies to brigatinib: oral tablet.

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.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Female patients should use effective birth control (eg, condoms, spermicide) along with their pills during treatment with this medicine and for at least 4 months after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 3 months after the last dose. If you think you or your partner becomes pregnant while using the medicine, tell your doctor right away.

This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms from lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a slow, fast, pounding, or uneven heartbeat.

Check with your doctor right away if you have any changes to your eyes, such as eye pain or redness, or vision changes while you are using this medicine. Your doctor may want your eyes be checked by an eye doctor (ophthalmologist).

This medicine may cause muscle damage. Check with your doctor right away if you have muscle pain, tenderness, and weakness.

Check with your doctor right away if you have loss of appetite, nausea, or pains in the stomach, side, or abdomen, possibly radiating to the back. These could be symptoms of pancreatitis (swelling of the pancreas).

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 increase your blood sugar levels. Check with your doctor right away if you have confusion, nausea or vomiting, increased hunger, thirst or urination, or unusual tiredness or weakness.

This medicine may cause an increased sensitivity of the skin to sunlight (photosensitivity). Check with your doctor right away if you have itching, redness or other discoloration of the skin, severe sunburn, or skin rash. Limit your time in the sun during treatment and for at least 5 days after the last dose. Use sunscreen or sunblock lotions with a sun protection factor (SPF) on a regular basis when you are outdoors. Wear protective clothing and hats and avoid sunlamps and tanning beds.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

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 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:

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:

For healthcare professionals

Applies to brigatinib: oral tablet.

General adverse events

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]

See also:

Further information

Brigatinib 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