Tasigna Side Effects

Generic Name: nilotinib

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

Some side effects of Tasigna may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to nilotinib: oral capsule

Along with its needed effects, nilotinib (the active ingredient contained in Tasigna) 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 nilotinib:

More common
  • Abdominal or stomach pain or tenderness
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blurred vision
  • bone pain
  • clay colored stools
  • confusion
  • convulsions
  • cough or hoarseness
  • dark urine
  • decreased appetite
  • difficult or labored breathing
  • dry mouth
  • fainting
  • fever or chills
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • irregular heartbeat, recurrent
  • loss of appetite
  • lower back or side pain
  • muscle aches, cramps, or pain
  • nausea and vomiting
  • no blood pressure
  • no breathing
  • no pulse
  • numbness, tingling, pain, or weakness in the hands or feet
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • seizures
  • skin rash or itching
  • sore throat
  • stuffy or runny nose
  • sweating
  • swelling of the hands, ankles, feet, or lower legs
  • tightness in the chest
  • trembling
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weakness and heaviness of the legs
  • yellow eyes or skin
Less common
  • Coma
  • decreased urine output
  • dizziness
  • fast heartbeat
  • muscle cramps in the hands, arms, feet, legs, or face
  • nervousness
  • numbness and tingling around the mouth, fingertips, or lips
  • tremor
Less common or rare
  • Bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • constipation
  • cough producing mucus
  • depressed mood
  • difficult, burning, or painful urination
  • dry skin and hair
  • ear congestion
  • feeling cold
  • frequent urge to urinate
  • hair loss
  • loss of voice
  • muscle stiffness
  • pain or tenderness around the eyes and cheekbones
  • sensitivity to heat
  • slowed heartbeat
  • sneezing
  • swelling or puffiness of the face
  • tender, swollen glands in the neck
  • trouble sleeping
  • trouble swallowing
  • weight changes
  • white patches in the mouth or throat or on the tongue
  • white patches with diaper rash
Incidence not known
  • Pain or swelling of the treated skin
  • rapid, shallow breathing

Some side effects of nilotinib 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
  • Back pain
  • burning, itching, and pain in hairy areas
  • diarrhea
  • difficulty with moving
  • lack or loss of strength
  • muscle spasms
  • pain in the arms or legs
  • pain in the joints
  • pus at the root of the hair
  • swollen joints

For Healthcare Professionals

Applies to nilotinib: oral capsule

Hematologic

Hematologic side effects including thrombocytopenia (up to 37%), neutropenia (up to 37%), anemia (up to 23%), febrile neutropenia, pancytopenia, thrombocytosis, and leukocytosis have been reported.

Dermatologic

Dermatologic side effects including rash (up to 33%), pruritus (up to 29%), night sweats, eczema, urticaria, alopecia, erythema, hyperhidrosis, dry skin, exfoliative rash, ecchymosis, swelling face, erythema nodosum, skin ulcer, petechiae, and photosensitivity have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea (up to 31%), diarrhea (up to 22%), constipation (up to 21%), vomiting (up to 21%), abdominal pain (up to 13%), gastroenteritis, abdominal discomfort, dyspepsia, flatulence, pancreatitis, gastrointestinal hemorrhage, melena, abdominal distension, mouth ulceration, gastroesophageal reflux, stomatitis, dry mouth, gastrointestinal ulcer perforation, retroperitoneal hemorrhage, hematemesis, gastric ulcer, esophagitis ulcerative, and near complete obstruction of the intestine have been reported.

Nervous system

Nervous system side effects including headache (up to 31%), dizziness, paresthesia, intracranial hemorrhage, migraine, tremor, hypoesthesia, hyperesthesia, brain edema, loss of consciousness, optic neuritis, and peripheral neuropathy have been reported.

General

General side effects including fatigue (up to 28%), pyrexia (up to 24%), asthenia (up to 14%), peripheral edema (up to 11%), dehydration, decreased appetite, increased appetite, pyrexia, chest pain, face edema, gravitational edema, influenza-like illness, chills, and malaise have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (up to 18%), pain in extremity (up to 16%), myalgia (14%), muscle spasms (up to 14%), bone pain (up to 13%), back pain (up to 12%), musculoskeletal chest pain, musculoskeletal pain, muscular weakness, arthritis, and joint swelling have been reported.

Cardiovascular

Cardiovascular side effects including palpitations, electrocardiogram QT prolonged, cardiac failure, angina pectoris, atrial fibrillation, pericardial effusion, coronary artery disease, cardiomegaly, cardiac murmur, bradycardia, myocardial infarction, ventricular dysfunction, pericarditis, cardiac flutter, extrasystoles, hypertension, flushing, hypertensive crisis, hematoma, hemorrhagic shock, hypotension, thrombosis, and peripheral arterial occlusive disease have been reported.

Respiratory

Respiratory side effects including cough (up to 17%), nasopharyngitis (up to 16%), dyspnea (up to 11%), pneumonia, pharyngitis, bronchitis, exertional dyspnea, cough, dysphonia, pulmonary edema, pleural effusion, interstitial lung disease, pleuritic pain, pleurisy, epistaxis, pharyngolaryngeal pain, throat irritation, and pulmonary hypertension have been reported.

Metabolic

Metabolic side effects including elevated lipase (up to 17%), hyperglycemia (up to 11%), hypophosphatemia (10%), hypokalemia (up to 5%), hyperkalemia (up to 4%), hypocalcemia (up to 4%), elevated alkaline phosphatase (3%), hyponatremia (3%), decreased albumin (1%), elevated creatinine (less than 1%), hypomagnesemia, hyperkalemia, hyperglycemia, anorexia, hypokalemia, hyponatremia, hypocalcemia, hypophosphatemia, diabetes mellitus, hypercalcemia, hyperphosphatemia, increased blood amylase, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, increased blood alkaline phosphatase, increased gamma-glutamyltransferase, increased blood creatinine phosphokinase, increased blood glucose, decreased weight, increased weight, increased blood lactate dehydrogenase, decreased blood glucose, increased blood creatinine, increased blood urea, increased troponin, decreased blood potassium, and increased unconjugated blood bilirubin have been reported.

Genitourinary

Genitourinary side effects including breast pain, gynecomastia, and erectile dysfunction have been reported.

Other

Other side effects including sepsis, herpes simplex, candidiasis, vertigo, impaired hearing, and ear pain have been reported.

Endocrine

Endocrine side effects including hyperthyroidism, hypothyroidism, and thyroiditis have been reported.

Psychiatric

Psychiatric side effects including insomnia, depression, anxiety, disorientation, and confusional state have been reported.

Hepatic

Hepatic side effects including elevated total bilirubin (up to 10%), elevated SGPT (ALT) (up to 4%), elevated SGOT (AST) (1%), hepatitis, hepatotoxicity, hepatomegaly, and jaundice have been reported.

Ocular

Ocular side effects including eye hemorrhage, visual acuity reduced, periorbital edema, conjunctivitis, eye irritation, dry-eye, papilledema, diplopia, vision blurred, photophobia, eye swelling, blepharitis, and eye pain have been reported.

Renal

Renal side effects including dysuria, micturition urgency, nocturia, pollakiuria, renal failure, hematuria, urinary incontinence, and urinary tract infection have been reported.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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