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Bosulif Side Effects

Generic Name: bosutinib

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

In 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. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to bosutinib: oral tablet

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
  • 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

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
  • Flaking and falling off of the skin

For Healthcare Professionals

Applies to bosutinib: oral tablet


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


Common (1% to 10%): Pericardial effusion, chest pain, prolonged QT interval
Uncommon (0.1% to 1%): Pericarditis[Ref]


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]


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]


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]


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]


Common (1% to 10%): Drug hypersensitivity
Uncommon (0.1% to 1%): Anaphylactic shock[Ref]


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]


Very common (10% or more): Decreased appetite (up to 13%)
Common (1% to 10%): Hyperkalemia, dehydration
Frequency not reported: Fluid retention[Ref]


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]


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]


Common (1% to 10%): Increased blood creatinine
Uncommon (0.1% to 1%): Acute renal failure, renal failure, renal impairment[Ref]


1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Bosulif (bosutinib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

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

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. 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.