Entrectinib Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 1, 2024.

Applies to entrectinib: oral capsule, oral pellet.

Precautions

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

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 5 weeks after your final dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for 3 months after the last dose. If you think you have become pregnant, tell your doctor right away.

Check with your doctor right away if you or your child have a chest pain that is worse than usual, trouble breathing, nausea or vomiting, pain or discomfort in your arms, jaw, back, or neck, feel faint, or you are sweating. This medicine may worsen the symptoms of an existing heart problem.

This medicine may cause dizziness, fainting, tiredness, blurred vision, memory loss, changes in mental status, confusion, or hallucinations. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert.

This medicine may increase your risk of bone fractures. Ask your doctor about ways to keep your bones strong to help prevent fractures.

Check with your doctor right away if you or your child 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.

Contact your doctor right away if you or your child have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Cancer medicines can cause constipation, diarrhea, nausea, or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.

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 entrectinib

Along with its needed effects, entrectinib 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 entrectinib:

Other side effects of entrectinib

Some side effects of entrectinib 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:

See also:

For healthcare professionals

Applies to entrectinib: oral capsule, oral pellet.

General adverse events

The most common adverse reactions (20% or greater) are fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, myalgia, cognitive impairment, increased weight, cough, vomiting, pyrexia, arthralgia, and vision disorders.^[Ref]

Immunologic

• Common (1% to 10%): Pneumonia, sepsis^[Ref]

Musculoskeletal

• Very common (10% or more): Myalgia (e.g., musculoskeletal pain, musculoskeletal chest pain, myalgia, neck pain) (28%), fractures in children (e.g., hip, femoral or tibial shaft, bilateral femoral neck) (23%), arthralgia (21%), muscular weakness (12%), back pain (12%), pain in extremity (11%)
• Common (1% to 10%): Fractures in adults (e.g. hip, femoral or tibial shaft, bilateral femoral neck)
• Very rare (less than 0.01%): Tumor lysis syndrome (TLS)^[Ref]

Ocular

• Very common (10% or more): Vision disorders (e.g., blindness, cataract, cortical cataract, corneal erosion, diplopia, eye disorder, photophobia, photopsia, retinal hemorrhage, vision blurred, visual impairment, vitreous adhesions, vitreous detachment, vitreous floaters) (21%)^[Ref]

Metabolic

• Very common (10% or more): Hyperuricemia (52%), hypernatremia (35%), hypocalcemia (34%), hypophosphatemia (30%), hypoalbuminemia (28%), weight gain (25%), hyperkalemia (25%), anorexia (13%), dehydration (10%)
• Uncommon (0.1% to 1%): Tumor lysis syndrome (TLS)^[Ref]

Psychiatric

• Very common (10% or more): Cognitive impairment (e.g., amnesia, aphasia, cognitive disorder, confusional state, delirium, disturbance in attention, hallucinations, visual hallucination, memory impairment, mental disorder, mental status changes (27%), sleep disorder (e.g., hypersomnia, insomnia, sleep disorder, somnolence) (14%), mood disorder (e.g., anxiety, affect lability, affective disorder, agitation, depressed mood, euphoric mood, mood altered, mood swings, irritability, depression, persistent depressive disorder, psychomotor retardation) (10%)^[Ref]

Genitourinary

• Very common (10% or more): Urinary tract infection (13%)^[Ref]

Hepatic

• Very common (10% or more): Increased AST (44%), increased ALT (38%), increased alkaline phosphatase (25%)^[Ref]

Respiratory

• Very common (10% or more): Dyspnea (30%), cough (24%), lung infection (e.g., lower respiratory tract infection, lung infection, pneumonia, respiratory tract infection) (10%)
• Common (1% to 10%): Pleural effusion, pulmonary embolism, respiratory failure, hypoxia^[Ref]

Other

• Very common (10% or more): Fatigue/asthenia (48%), edema (e.g., face edema, fluid retention, generalized edema, localized edema, edema, edema peripheral, peripheral swelling) (40%), pyrexia (21%)^[Ref]

Hematologic

• Very common (10% or more): Anemia (67%), lymphopenia (40%), neutropenia (28%)^[Ref]

Nervous system

• Very common (10% or more): Dysgeusia (44%), dizziness (e.g., dizziness, vertigo, dizziness postural) (38%), dysesthesia (e.g., paresthesia, hyperesthesia, hypoesthesia, dysesthesia, oral hypoesthesia, palmar-plantar erythrodysesthesia, oral paresthesia, genital hypoesthesia) (34%), headache (21%), paresthesia (20%), peripheral sensory neuropathy (e.g., neuralgia, neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy) (18%), ataxia (e.g., ataxia, balance disorder, gait disturbance) (18%), dysphagia (10%)
• Common (1% to 10%): Aphasia, fall^[Ref]

Renal

• Very common (10% or more): Increased creatinine (73%)^[Ref]

Cardiovascular

• Very common (10% or more): Hypotension (e.g., hypotension, orthostatic hypotension) (18%)
• Common (1% to 10%): Congestive heart failure (CHF), QT interval prolongation, syncope^[Ref]

Dermatologic

• Very common (10% or more): Rash (e.g., rash, rash maculopapular, rash pruritic, rash erythematous, rash papular) (11%)^[Ref]

Gastrointestinal

• Very common (10% or more): Constipation (46%), diarrhea (35%), nausea (34%), increased lipase (28%), increased amylase (26%), vomiting (24%), abdominal pain (e.g., abdominal pain upper, abdominal pain, lower abdominal discomfort, abdominal tenderness) (16%)
• Uncommon (0.1% to 1%): Large intestine perforation^[Ref]

Further information

Entrectinib 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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