What the label lists and what reports show
Bosutinib side effects
Bosutinib's FDA label: “Most common adverse reactions (≥20%), in adult and pediatric patients with CML are diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite respiratory tract infection, and constipation.” FAERS holds 8,931 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (2,071 reports).
- Generic listed
Check it at the source: the bosutinib FDA label on DailyMed (effective March 10, 2026, Pfizer Laboratories Div Pfizer Inc); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of BOSULIF?BOSULIF may cause serious side effects, including: • Stomach problems. BOSULIF may cause stomach (abdomen) pain, nausea, diarrhea, vomiting, or blood in your stools. Get medical help right away for 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. 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. […]
Source: FDA drug label, NDA203341 (Pf Prism Cv), as published by Pfizer Laboratories Div Pfizer Inc, effective March 10, 2026 (SPL set adc84ad5-a04d-4fee-9ba8-91f7abd928e3), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥20%), in adult and pediatric patients with CML are diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite respiratory tract infection, and constipation.
Table 7: Adverse Reactions (10% or Greater) in Patients With Newly-Diagnosed CML in Bosutinib 400 mg Study Based on a Minimum of 57 Months of Follow-up. Adverse drug reactions are based on all-causality…
| Preferred Term | All Grades % | Grade 3/4 % | All Grades % | Grade 3/4 % |
|---|---|---|---|---|
| Diarrhea | 75 | 9 | 40 | 1 |
| Hepatic dysfunction Hepatic dysfunction includes the preferred terms: Alanine… | 45 | 27 | 15 | 4 |
| Rash Rash includes the following preferred terms: Acne, Blister, Dermatitis, Dermatitis… | 40 | 2 | 30 | 2 |
| Fatigue Fatigue includes the following preferred terms: Asthenia, Fatigue, Malaise. | 33 | 1 | 30 | <1 |
| Respiratory tract infection Respiratory tract infection includes the following preferred… | 27 | 1 | 25 | <1 |
| Headache | 22 | 1 | 15 | 1 |
| Arthralgia | 18 | 1 | 18 | <1 |
| Cough | 11 | 0 | 10 | 0 |
| Decreased appetite | 11 | <1 | 6 | 0 |
| Hypertension Hypertension* includes the preferred terms: Blood pressure systolic… | 10 | 5 | 11 | 5 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Gastrointestinal toxicity [see Warnings and Precautions (5.1) ]. • Myelosuppression [see Warnings and Precautions (5.2) ]. • Hepatic toxicity [see Warnings and Precautions (5.3) ]. • Cardiovascular toxicity [see Warnings and Precautions (5.4) ]. • Fluid retention [see Warnings and Precautions (5.5) ]. • Renal toxicity [see Warnings and Precautions (5.6) ]. • Most common adverse reactions (≥20%), in adult and pediatric patients with CML are diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite respiratory tract infection, and constipation. The most common laboratory abnormalities (≥20%) in adult and pediatric patients are creatinine increased, hemoglobin decreased, lymphocyte count decreased, platelets decreased, ALT increased, calcium decreased, white blood cell count decreased, AST increased, absolute neutrophil count decreased, glucose increased, phosphorus decreased, urate increased, alkaline phosphatase increased, lipase increased, creatine kinase increased, and amylase increased.
Source: FDA drug label, NDA203341 (Pf Prism Cv), as published by Pfizer Laboratories Div Pfizer Inc, effective March 10, 2026 (SPL set adc84ad5-a04d-4fee-9ba8-91f7abd928e3), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,931 reports list bosutinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 782 are coded as a death and 1,918 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 18 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Bosutinib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions