OpenClaim

Bosutinib Side Effects

The most commonly reported side effects of bosutinib include diarrhoea, nausea, and fatigue, based on 8,782 FDA adverse event reports from 2009 to 2025. 3.0% of reports found the drug to be ineffective.

Bosutinib side effects

Percentages show how often each reaction appears relative to total reports for bosutinib.

1
Diarrhoea23.3%2,049
2
Nausea11.4%1,001
3
Fatigue8.1%714
4
Vomiting6.1%533
5
Death5.7%502
6
Rash5.5%487
7
Pleural Effusion5.0%441
8
Neoplasm Progression4.3%376
9
Dyspnoea4.1%361
10
Headache3.8%331
11
Off Label Use3.6%314
12
Drug Intolerance3.6%313
13
Malaise3.4%300
14
Drug Ineffective3.0%265
15
Abdominal Pain3.0%262

These are voluntary reports and do not establish that bosutinib caused these reactions.

Report severity

55.6%Serious4,882 reports
21.4%Hospitalizations1,879 reports
8.5%Fatal748 reports

Seriousness is determined by the reporter, not by OpenClaim.

Bosutinib drug interactions

Other drugs that appear in adverse event reports alongside bosutinib. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Dasatinib10.5%925
2
Imatinib-mesylate9.3%820
3
Nilotinib8.1%711
4
Ponatinib-hydrochloride3.5%304
5
Asciminib-hydrochloride1.3%113
6
Hydroxyurea0.7%60
7
Ondansetron0.4%32
8
Loperamide-hydrochloride0.4%32
9
Rosuvastatin0.3%24
10
Ruxolitinib0.3%23
11
Apixaban0.3%23
12
Amlodipine0.3%22
13
Oxycodone0.2%21
14
Omacetaxine-mepesuccinate0.2%19
15
Lisinopril0.2%18

Taken alongside

1
Furosemide4.7%414
2
Aspirin4.4%390
3
Amlodipine3.5%310
4
Metoprolol3.3%292
5
Atorvastatin-calcium3.2%283
6
Ergocalciferol3.2%278
7
Allopurinol3.0%267
8
Acetaminophen3.0%260
9
Levothyroxine-sodium2.9%259
10
Ondansetron2.6%226
11
Omeprazole2.2%192
12
Metformin2.2%191
13
Gabapentin2.1%187
14
Lisinopril2.1%185
15
Pantoprazole-sodium1.9%171

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports bosutinib side effects

46.1% of bosutinib adverse event reports involve female patients and 44.7% involve male patients. The largest age group is elderly at 51%. These figures reflect who reports side effects, not underlying risk.

Sex

Female46.1%
Male44.7%
Unknown9.2%

Age group

< 20.0%
2–11<0.1%
12–170.3%
18–6448.7%
65+50.9%

What is bosutinib used for

Conditions and purposes for which patients were taking bosutinib when the adverse event was reported.

Acquired Gene MutationAcute Biphenotypic LeukaemiaAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAcute Myeloid LeukaemiaAcute Myelomonocytic LeukaemiaAcute Promyelocytic LeukaemiaAnaemiaArthralgiaAstrocytoma MalignantAblepharon Macrostomia SyndromeAcute LeukaemiaAcute Leukaemia In RemissionAcute Lymphocytic Leukaemia

Showing 15 of 213 indications

Bosutinib brand names and reporting trend

Bosutinib is sold under the brand name Bosulif.

Brand names

Bosulif8

Quarterly reports (20092025)

20092016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking bosutinib with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.