Entrectinib Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 29, 2022.

Applies to entrectinib: oral capsule.

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:

More common

Abdominal or stomach pain or tenderness
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
change in color vision
clay colored stools
confusion
dark urine
decreased appetite
defects in intelligence, short-term memory, learning ability, and attention
difficulty seeing at night
dizziness
fever
headache
increased sensitivity of the eyes to sunlight
itching or skin rash
joint pain, stiffness, or swelling
loss of appetite
lower back, side, or stomach pain
nausea and vomiting
problems with balance
sleepiness or unusual drowsiness
swelling of the feet or lower legs
trouble sleeping
unusual tiredness or weakness
yellow eyes or skin

Less common

Chest pain
decreased urine output
dilated neck veins
double vision
extreme fatigue
fainting
irregular breathing
irregular heartbeat recurrent
loss of memory
problems with memory
problems with speech or speaking
seeing double
seeing, hearing, or feeling things that are not there
swelling of the face, fingers, feet, or lower legs
tightness in the chest
trouble remembering
troubled breathing
weight gain

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:

More common

Change or loss of taste
diarrhea
difficulty having a bowel movement (stool)

For Healthcare Professionals

Applies to entrectinib: oral capsule.

Hematologic

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

General

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]

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]