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

Summary

Common side effects of Bosulif include: diarrhea, abdominal pain, anemia, edema, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, nausea, neutropenia, peripheral edema, thrombocytopenia, and vomiting. Continue reading for a comprehensive list of adverse effects.

Applies to bosutinib: oral tablet.

Serious side effects of Bosulif

Along with its needed effects, bosutinib (the active ingredient contained in Bosulif) 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 bosutinib:

More common

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• chills
• cough
• difficult or labored breathing
• fever
• lower back or side pain
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• sore throat
• swelling of the hands, ankles, feet, or lower legs
• tightness in the chest
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Agitation
• chest pain or discomfort
• clay-colored stools
• cough with mucus
• confusion
• dark urine
• decreased appetite
• decreased urination
• depression
• diarrhea
• dizziness
• dry mouth
• fainting
• fast or irregular heartbeat
• general feeling of discomfort or illness
• headache
• hives, itching, or skin rash
• hoarseness
• hostility
• increased sweating
• increased thirst
• irritation
• joint pain, stiffness or swelling
• lightheadedness
• loss of appetite
• muscle aches, pains, or twitching
• nausea
• numbness or tingling in the hands, feet, or lips
• rapid breathing
• rapid weight gain
• redness of the skin
• runny nose
• seizures
• shivering
• sneezing
• stomach pain or tenderness
• sunken eyes
• swelling of the eyelids, face, lips, hands, or feet
• thirst
• trouble sleeping
• trouble swallowing
• vomiting
• weakness or heaviness of the legs
• wrinkled skin

Rare

• Blistering, peeling, or loosening of the skin
• bloating
• blue lips, fingernails, or skin
• chest pain, possibly moving to the left arm, neck, or shoulder
• constipation
• coughing that sometimes produces a pink frothy sputum
• difficult, noisy breathing
• indigestion
• irregular, fast or slow, or shallow breathing
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• red, irritated eyes
• vomiting of blood or material that looks like coffee grounds
• yellow eyes or skin

Other side effects of Bosulif

Some side effects of bosutinib 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
• difficulty with moving
• lack or loss of strength
• muscle stiffness
• stuffy nose

Less common

• Blemishes on the skin
• burning feeling in the chest or stomach
• change in taste
• hearing loss
• loss of taste
• muscle cramping
• pimples
• ringing, buzzing, or other unexplained noise in the ears that continues
• stomach upset

Rare

• Flaking and falling off of the skin

For Healthcare Professionals

Applies to bosutinib: oral tablet.

General

The most commonly reported side effects were diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia, and fatigue.^[Ref]

Cardiovascular

Common (1% to 10%): Pericardial effusion, chest pain, prolonged QT interval

Uncommon (0.1% to 1%): Pericarditis^[Ref]

Hematologic

Very common (10% or more): Low platelet count (less than 50 × 10(9)/L, up to 57%), thrombocytopenia (up to 40%), absolute neutrophil count (less than 1 × 10(9)/L, up to 37%), Low hemoglobin (less than 80 g/L, up to 35%), anemia (up to 27%), neutropenia (16%), leukopenia (11%)

Common (1% to 10%): Febrile neutropenia

Uncommon (0.1% to 1%): Granulocytopenia

Frequency not reported: Myelosuppression^[Ref]

Hepatic

Very common (10% or more): Increased alanine aminotransferase (up to 22%), increased aspartate aminotransferase (up to 18%)

Common (1% to 10%): Increased bilirubin [greater than 3 times the upper limit of normal (3 x ULN)], hepatotoxicity, abnormal hepatic function, increased gamma-glutamyltransferase

Uncommon (0.1% to 1%): Liver injury

Frequency not reported: Hepatic toxicity^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 84%), nausea (up to 46%), abdominal pain (up to 40%), vomiting (up to 37%)

Common (1% to 10%): Increased lipase (greater than 2 × ULN), gastritis, increased blood amylase

Uncommon (0.1% to 1%): Acute pancreatitis, gastrointestinal hemorrhage

Frequency not reported: Gastrointestinal toxicity^[Ref]

Dermatologic

Very common (10% or more): Rash (up to 34%), pruritus (up to 11%)

Common (1% to 10%): Urticaria, pruritus, acne

Uncommon (0.1% to 1%): Erythema multiforme, exfoliative rash, drug eruption^[Ref]

Hypersensitivity

Common (1% to 10%): Drug hypersensitivity

Uncommon (0.1% to 1%): Anaphylactic shock^[Ref]

Respiratory

Very common (10% or more): Cough (up to 20%), nasopharyngitis (up to 12%), respiratory tract infection (up to 12%), dyspnea (up to 10%)

Common (1% to 10%): Pneumonia, influenza, bronchitis, pleural effusion

Uncommon (0.1% to 1%): Acute pulmonary edema, respiratory failure, pulmonary hypertension^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 13%)

Common (1% to 10%): Hyperkalemia, dehydration

Frequency not reported: Fluid retention^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 14%), back pain (up to 12%)

Common (1% to 10%): Myalgia^[Ref]

Nervous system

Very common (10% or more): Headache (up to 20%), dizziness (up to 10%)

Common (1% to 10%): Dysgeusia^[Ref]

Other

Very common (10% or more): Fatigue (up to 26%), pyrexia (up to 22%), edema (up to 14%), asthenia (11%)

Common (1% to 10%): Low phosphorus (less than 0.6 mmol/L), tinnitus, pain, increased blood creatine phosphokinase^[Ref]

Renal

Common (1% to 10%): Increased blood creatinine

Uncommon (0.1% to 1%): Acute renal failure, renal failure, renal impairment^[Ref]