Bosulif Side Effects

Generic Name: bosutinib

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

Not all side effects for Bosulif may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to bosutinib: oral tablet

In addition to its needed effects, some unwanted effects may be caused by bosutinib (the active ingredient contained in Bosulif). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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
  • shortness of breath
  • 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
  • wheezing
Less common
  • Abdominal or stomach pain or tenderness
  • 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
  • hoarseness
  • hostility
  • increased sweating
  • increased thirst
  • irritation
  • itching
  • joint pain, stiffness or swelling
  • lightheadedness
  • loss of appetite
  • muscle aches, pains, or twitching
  • nausea or vomiting
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • rapid breathing
  • rapid weight gain
  • redness of the skin
  • runny nose
  • seizures
  • shivering
  • skin rash
  • sneezing
  • sunken eyes
  • swelling of the eyelids, face, lips, hands, or feet
  • thirst
  • trouble sleeping
  • trouble swallowing
  • weakness or heaviness of the legs
  • wrinkled skin
Rare
  • Anxiety
  • blistering, peeling, 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, sometimes with wheezing
  • 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 of the side effects that can occur with bosutinib may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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
  • tenderness in the stomach area
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]

References

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

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

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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