Ayvakit Side Effects

Generic name: avapritinib

Medically reviewed by Drugs.com. Last updated on Feb 9, 2024.

Note: This document contains side effect information about avapritinib. Some dosage forms listed on this page may not apply to the brand name Ayvakit.

Applies to avapritinib: oral tablet.

Serious side effects of Ayvakit

Along with its needed effects, avapritinib (the active ingredient contained in Ayvakit) 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 avapritinib:

More common

• Bladder pain
• bloody or cloudy urine
• blurred vision
• body aches or pain
• chest tightness
• defects in intelligence, short-term memory, learning ability, and attention
• dizziness
• ear congestion
• headache
• loss of voice
• lower back or side pain
• mood or mental changes
• nervousness
• pale skin
• pounding in the ears
• runny or stuffy nose
• slow or fast heartbeat
• sneezing
• sore throat
• trouble sleeping
• trouble with breathing
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Agitation
• black, tarry stools
• bloody stools
• chest pain
• chills
• confusion
• constipation
• cough
• decreased awareness or responsiveness
• decreased urine output
• depressed mood
• difficult, burning, or painful urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry skin and hair
• dilated neck veins
• fainting
• feeling cold
• fever
• frequent urge to urinate
• gaseous stomach pain
• hair loss
• hoarseness or husky voice
• hostility
• increased sensitivity of the skin to sunlight
• irritability
• lightheadedness
• loss of consciousness
• muscle cramps, stiffness, and twitching
• nausea
• pounding in the ears
• rapid weight gain
• rapid, shallow breathing
• redness or other discoloration of the skin
• seizures
• sensitivity to heat
• severe sleepiness
• severe sunburn
• skin rash
• sneezing
• sore throat
• stomach pain and bloating
• sweating
• swelling of the face, ankles, or hands
• swelling of the finger, feet, or lower legs
• unusual drowsiness, dullness, or feeling of sluggishness
• vomiting of blood or material that looks like coffee grounds
• weight gain or loss
• yellow eyes or skin

Other side effects of Ayvakit

Some side effects of avapritinib 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

• Bad unusual or unpleasant (after)taste
• belching
• change in taste
• decreased appetite
• diarrhea
• difficulty in moving
• feeling of warmth
• redness of the face, neck, arms and occasionally, upper chest
• hair color changes
• heartburn
• increased tearing
• indigestion
• muscle pain or stiffness
• pain in the joints
• skin rash
• stomach discomfort, upset, or pain
• swelling of the eye, eyelid, or inner lining of the eyelid
• vomiting

Less common

• Redness or pain of the skin
• scaling of the skin on the hands and feet
• tingling of the hands and feet
• ulceration of the skin

For Healthcare Professionals

Applies to avapritinib: oral tablet.

General

The most common adverse reactions (20% or greater) were edema, nausea, fatigue/asthenia, cognitive impairment, vomiting, decreased appetite, diarrhea, increased lacrimation, abdominal pain, constipation, rash, dizziness, and hair color changes.^[Ref]

Cardiovascular

Very common (10% or more): Flushing (up to 11%)

Common (1% to 10%): Intracranial hemorrhage, cardiac failure, congestive cardiac failure, hypotension

Dermatologic

Very common (10% or more): Rash (up to 23%), hair color changes (up to 21%), alopecia (up to 13%)

Common (1% to 10%): Palmar-plantar erythrodysesthesia, pruritus, photosensitivity

Rash includes maculo-papular rash, erythematous rash, macular rash, generalized rash, and papular rash.

Endocrine

Common (1% to 10%): Thyroid disorders (e.g., hyperthyroid, hypothyroid)

Gastrointestinal

Very common (10% or more): Nausea (up to 64%), vomiting (up to 38%), diarrhea (up to 37%), abdominal pain (up to 31%), constipation (up to 23%), dyspepsia (up to 16%)

Common (1% to 10%): Large intestine perforation

Abdominal pain includes upper abdominal pain, abdominal discomfort, lower abdominal pain, abdominal tenderness, and epigastric discomfort.

Hematologic

Very common (10% or more): Decreased hemoglobin (up to 81%), decreased leukocytes (up to 62%), decreased neutrophils (up to 54%), decreased platelets (up to 64%), decreased lymphocytes (up to 34%), increased INR (up to 24%), increased activated partial thromboplastin time (up to 14%), hemorrhage (up to 11%), increased lymphocytes (up to 10%)

Common (1% to 10%): Hematoma

Hematoma includes contusion, hematoma, and pelvic hematoma.

Hemorrhage includes epistaxis, gingival bleeding, hematochezia, rectal hemorrhage, gastrointestinal hemorrhage, and retinal hemorrhage.

Hepatic

Very common (10% or more): Increased bilirubin (up to 69%), increased AST (up to 51%), increased ALT (up to 19%)

Common (1% to 10%): Cholelithiasis

Metabolic

Very common (10% or more): Decreased calcium (up to 50%), decreased appetite (up to 38%), decreased phosphate (up to 49%), decreased potassium (up to 34%), decreased albumin (up to 31%), decreased magnesium (29%), decreased sodium (28%), increased alkaline phosphatase (24%), decreased weight (up to 13%), increased potassium (up to 11%)

Musculoskeletal

Very common (10% or more): Arthralgia (up to 10%)

Common (1% to 10%): Pain in extremity

Nervous system

Cognitive impairment/effects include memory impairment, cognitive disorder, confusional state, disturbance in attention, amnesia, mental impairment, mental status changes, encephalopathy, dementia delirium, disorientation, abnormal thinking, mental disorder, and retrograde amnesia.

Very common (10% or more): Cognitive impairment (up to 48%), dizziness (up to 22%), headache (up to 17%), dysgeusia/ageusia (up to 15%)

Ocular

Very common (10% or more): Increased lacrimation (up to 33%)

Other

Very common (10% or more): Edema (up to 79%), fatigue/asthenia (up to 61%), pyrexia (up to 14%)

Common (1% to 10%): Herpes zoster

Edema includes face swelling, conjunctival edema, eye edema, eyelid edema, orbital edema, periorbital edema, face edema, mouth edema, pharyngeal edema, peripheral edema, edema, generalized edema, localized edema, peripheral swelling, and testicular edema.

Psychiatric

Very common (10% or more): Sleep disorders (up to 16%), mood disorders (up to 13%)

Common (1% to 10%): Speech disorders

Frequency not reported: Hallucinations

Sleep disorders include insomnia, and somnolence.

Mood disorders include agitation, anxiety, depression, depressed mood, dysphoria, irritability, mood altered, nervousness, personality change, and suicidal ideation.

Renal

Very common (10% or more): Creatinine increased (up to 29%)

Common (1% to 10%): Urinary tract infection

Respiratory

Very common (10% or more): Dyspnea (up to 17%), pleural effusion (up to 12%)

Common (1% to 10%): Respiratory tract infection, cough

Respiratory tract infection includes pneumonia, upper respiratory tract infection, bronchitis and respiratory tract infection.

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