BOSUTINIB

N/A

Manufactured by Pfizer Laboratories Div Pfizer Inc

17,905 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BOSUTINIB

BOSUTINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. The most commonly reported adverse reactions for BOSUTINIB include DIARRHOEA, NAUSEA, FATIGUE, VOMITING, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BOSUTINIB.

Top Adverse Reactions

DIARRHOEA2,048 reports
NAUSEA1,001 reports
FATIGUE714 reports
VOMITING533 reports
DEATH500 reports
RASH484 reports
PLEURAL EFFUSION440 reports
NEOPLASM PROGRESSION376 reports
DYSPNOEA360 reports
HEADACHE331 reports
OFF LABEL USE314 reports
DRUG INTOLERANCE313 reports
MALAISE299 reports
DRUG INEFFECTIVE268 reports
ABDOMINAL PAIN262 reports
ARTHRALGIA246 reports
ABDOMINAL PAIN UPPER244 reports
ASTHENIA244 reports
PAIN220 reports
WEIGHT DECREASED215 reports
ABDOMINAL DISCOMFORT210 reports
CONSTIPATION206 reports
PNEUMONIA205 reports
PYREXIA194 reports
DECREASED APPETITE192 reports
ILLNESS186 reports
DIZZINESS183 reports
PRURITUS173 reports
BACK PAIN151 reports
ANAEMIA148 reports
FLUID RETENTION147 reports
COUGH144 reports
DRUG RESISTANCE143 reports
CHRONIC MYELOID LEUKAEMIA140 reports
PAIN IN EXTREMITY137 reports
PULMONARY OEDEMA136 reports
MYALGIA135 reports
MYOCARDIAL INFARCTION133 reports
CHEST PAIN131 reports
DEHYDRATION123 reports
GASTROINTESTINAL DISORDER121 reports
HYPERTENSION117 reports
PLATELET COUNT DECREASED117 reports
BONE PAIN114 reports
MUSCLE SPASMS113 reports
WEIGHT INCREASED113 reports
COVID 19112 reports
HEPATIC ENZYME INCREASED112 reports
PRODUCT DOSE OMISSION ISSUE112 reports
DISEASE PROGRESSION109 reports
HAEMOGLOBIN DECREASED108 reports
THROMBOCYTOPENIA107 reports
CYTOGENETIC ANALYSIS ABNORMAL106 reports
FALL105 reports
PERIPHERAL SWELLING103 reports
RENAL FAILURE103 reports
WHITE BLOOD CELL COUNT INCREASED102 reports
CARDIAC DISORDER101 reports
FEELING ABNORMAL101 reports
ATRIAL FIBRILLATION100 reports
CARDIAC FAILURE100 reports
CEREBROVASCULAR ACCIDENT100 reports
RENAL IMPAIRMENT99 reports
SECOND PRIMARY MALIGNANCY99 reports
DYSPEPSIA98 reports
CARDIAC FAILURE CONGESTIVE96 reports
ALOPECIA90 reports
PERICARDIAL EFFUSION89 reports
CONDITION AGGRAVATED88 reports
DRUG INTERACTION88 reports
DRUG HYPERSENSITIVITY87 reports
MEMORY IMPAIRMENT87 reports
WHITE BLOOD CELL COUNT DECREASED83 reports
ALANINE AMINOTRANSFERASE INCREASED80 reports
OEDEMA80 reports
HYPOACUSIS79 reports
INSOMNIA78 reports
RENAL DISORDER78 reports
ACUTE KIDNEY INJURY77 reports
DEPRESSION76 reports
GASTROOESOPHAGEAL REFLUX DISEASE76 reports
URTICARIA75 reports
GAIT DISTURBANCE74 reports
NASOPHARYNGITIS74 reports
BLOOD CREATININE INCREASED72 reports
HYPERSENSITIVITY70 reports
CYTOPENIA69 reports
INTENTIONAL PRODUCT MISUSE69 reports
LIVER FUNCTION TEST INCREASED69 reports
ABDOMINAL DISTENSION68 reports
PULMONARY HYPERTENSION68 reports
PANCREATITIS67 reports
THERAPY INTERRUPTED65 reports
PHILADELPHIA CHROMOSOME POSITIVE64 reports
PANCYTOPENIA63 reports
TREATMENT FAILURE62 reports
HOSPITALISATION61 reports
INFECTION61 reports
LIVER DISORDER61 reports
ASPARTATE AMINOTRANSFERASE INCREASED60 reports

Report Outcomes

Out of 8,763 classified reports for BOSUTINIB:

Serious 55.6%Non-Serious 44.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female4,044 (50.6%)
Male3,916 (49.0%)
Unknown33 (0.4%)

Reports by Age

Age 68214 reports
Age 69200 reports
Age 67199 reports
Age 60197 reports
Age 70191 reports
Age 63183 reports
Age 65182 reports
Age 75179 reports
Age 66175 reports
Age 72174 reports
Age 64172 reports
Age 73172 reports
Age 74166 reports
Age 76165 reports
Age 62152 reports
Age 77152 reports
Age 78152 reports
Age 71146 reports
Age 59145 reports
Age 61144 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with BOSUTINIB?

This profile reflects 17,905 FDA FAERS reports that mention BOSUTINIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BOSUTINIB?

Frequently reported terms in FAERS include DIARRHOEA, NAUSEA, FATIGUE, VOMITING, DEATH, RASH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BOSUTINIB?

Labeling and FAERS entries often list Pfizer Laboratories Div Pfizer Inc in connection with BOSUTINIB. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.