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Possible Side Effects | BOSULIF® (bosutinib) Tablets | Safety Info

Possible side effects

Possible side effects

BOSULIF may cause a range of side effects. Serious side effects include stomach problems, low blood cell counts, liver problems, and fluid retention.

One of the most common side effects was diarrhea. 82% of patients in the clinical trial experienced episodes of diarrhea while taking BOSULIF, and ≤2% of those patients discontinued treatment because of diarrhea.1

* The median is the “middle value” in a list of numbers. It is a kind of measurement. For example, the median number of episodes of diarrhea means that half of the patients in the study experienced more episodes of diarrhea, and half experienced fewer episodes of diarrhea.


What to do if you experience diarrhea

When you start taking BOSULIF, it may be helpful to ask your doctor how to prepare for possible episodes of diarrhea.

If you have diarrhea, call your doctor. Your doctor may recommend you take medicine to treat diarrhea. Always talk to your doctor before taking any over-the-counter medicines. Your doctor may choose to have you stop taking BOSULIF for a period of time or change your dose to help manage diarrhea.

You can also discuss the following tips with your doctor:

  • Avoid spicy foods, fatty foods, caffeine, and raw fruit
  • Eat mild foods
  • Drink water often

BOSULIF may cause serious side effects, including:

  • Stomach problems. BOSULIF may cause stomach (abdomen) pain, nausea, diarrhea, or vomiting. Tell your doctor about any stomach problems
  • Low blood cell counts. BOSULIF may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). Your doctor should do blood tests to check your blood cell counts regularly during your treatment with BOSULIF. Call your doctor right away if you have unexpected bleeding or bruising, blood in your urine or stools, fever, or any signs of an infection
  • Liver problems. BOSULIF may cause liver problems. Your doctor should do blood tests to check your liver function regularly during your treatment with BOSULIF. Call your doctor right away if your skin or the white part of your eyes turns yellow (jaundice) or you have dark “tea color” urine
  • Your body may hold too much fluid (fluid retention). Fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Call your doctor right away if you get any of the following symptoms during your treatment with BOSULIF:
    • – shortness of breath and cough
    • – chest pain
    • – swelling in your hands, ankles, or feet
    • – swelling all over your body
    • – weight gain
  • Kidney problems. BOSULIF may cause kidney problems. Your doctor should do tests to check your kidney function when you start treatment with BOSULIF and during your treatment. Call your doctor right away if you get any of the following symptoms during your treatment with BOSULIF:
    • you urinate more or less often than normal
    • you make a much larger or smaller amount of urine than normal
  • The most common side effects of BOSULIF include:
    • – diarrhea
    • – nausea
    • – low blood cell counts
    • – vomiting
    • – stomach pain
    • – rash
    • – fever
    • – tiredness or weakness


Reference: 1. Data on file. Pfizer Inc, New York, NY.

Scroll for Important Safety Information for patients and Indication.

BOSULIF may cause serious side effects, including:

  • Stomach problems. BOSULIF may cause stomach (abdomen) pain, nausea, diarrhea, or vomiting. Tell your doctor about any stomach problems
  • Low blood cell counts. BOSULIF may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia) and low white blood cell counts (neutropenia). Your doctor should do blood tests to check your blood cell counts regularly during your treatment with BOSULIF. Call your doctor right away if you have unexpected bleeding or bruising, blood in your urine or stools, fever, or any signs of an infection
  • Liver problems. BOSULIF may cause liver problems. Your doctor should do blood tests to check your liver function regularly during your treatment with BOSULIF. Call your doctor right away if your skin or the white part of your eyes turns yellow (jaundice) or you have dark “tea color” urine
  • Your body may hold too much fluid (fluid retention). Fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Call your doctor right away if you get any of the following symptoms during your treatment with BOSULIF:
    • – shortness of breath and cough
    • – chest pain
    • – swelling in your hands, ankles, or feet
    • – swelling all over your body
    • – weight gain
  • Kidney problems. BOSULIF may cause kidney problems. Your doctor should do tests to check your kidney function when you start treatment with BOSULIF and during your treatment. Call your doctor right away if you get any of the following symptoms during your treatment with BOSULIF:
    • you urinate more or less often than normal
    • you make a much larger or smaller amount of urine than normal
  • The most common side effects of BOSULIF include:
    • – diarrhea
    • – nausea
    • – low blood cell counts
    • – vomiting
    • – stomach pain
    • – rash
    • – fever
    • – tiredness or weakness

Before you take BOSULIF, tell your doctor if you:

  • have liver problems
  • have heart problems
  • have kidney problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. BOSULIF can harm your unborn baby. You should not become pregnant while taking BOSULIF. Tell your doctor right away if you become pregnant while taking BOSULIF
  • are a woman who may become pregnant. Use effective contraception (birth control) during and for at least 30 days after completing treatment with BOSULIF. Talk to your doctor about forms of birth control
  • are breastfeeding or plan to breastfeed. It is not known if BOSULIF passes into your breast milk or if it can harm your baby. You and your doctor should decide if you will take BOSULIF or breastfeed. You should not do both

Scroll for Important Safety Information for patients and Indication.

BOSULIF may cause serious side effects, including:

  • Stomach problems. BOSULIF may cause stomach (abdomen) pain, nausea, diarrhea, or vomiting. Tell your doctor about any stomach problems
  • Low blood cell counts. BOSULIF may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia) and low white blood cell counts (neutropenia). Your doctor should do blood tests to check your blood cell counts regularly during your treatment with BOSULIF. Call your doctor right away if you have unexpected bleeding or bruising, blood in your urine or stools, fever, or any signs of an infection
  • Liver problems. BOSULIF may cause liver problems. Your doctor should do blood tests to check your liver function regularly during your treatment with BOSULIF. Call your doctor right away if your skin or the white part of your eyes turns yellow (jaundice) or you have dark “tea color” urine
  • Your body may hold too much fluid (fluid retention). Fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Call your doctor right away if you get any of the following symptoms during your treatment with BOSULIF:
    • – shortness of breath and cough
    • – chest pain
    • – swelling in your hands, ankles, or feet
    • – swelling all over your body
    • – weight gain
  • Kidney problems. BOSULIF may cause kidney problems. Your doctor should do tests to check your kidney function when you start treatment with BOSULIF and during your treatment. Call your doctor right away if you get any of the following symptoms during your treatment with BOSULIF:
    • – you urinate more or less often than normal
    • – you make a much larger or smaller amount of urine than normal
  • The most common side effects of BOSULIF include:
    • – diarrhea
    • – nausea
    • – low blood cell counts
    • – vomiting
    • – stomach pain
    • – rash
    • – fever
    • – tiredness or weakness

Before you take BOSULIF, tell your doctor if you:

  • have liver problems
  • have heart problems
  • have kidney problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. BOSULIF can harm your unborn baby. You should not become pregnant while taking BOSULIF. Tell your doctor right away if you become pregnant while taking BOSULIF
  • are a woman who may become pregnant. Use effective contraception (birth control) during and for at least 30 days after completing treatment with BOSULIF. Talk to your doctor about forms of birth control
  • are breastfeeding or plan to breastfeed. It is not known if BOSULIF passes into your breast milk or if it can harm your baby. You and your doctor should decide if you will take BOSULIF or breastfeed. You should not do both