IMATINIB MESYLATE

N/A

Manufactured by Novartis Pharmaceuticals Corporation

47,520 FDA adverse event reports analyzed

Last updated: 2026-04-14

About IMATINIB MESYLATE

IMATINIB MESYLATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. The most commonly reported adverse reactions for IMATINIB MESYLATE include DEATH, NAUSEA, DIARRHOEA, FATIGUE, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IMATINIB MESYLATE.

Top Adverse Reactions

DEATH4,627 reports
NAUSEA2,118 reports
DIARRHOEA1,758 reports
FATIGUE1,511 reports
DRUG INEFFECTIVE1,390 reports
VOMITING1,280 reports
MALAISE1,077 reports
RASH997 reports
DYSPNOEA986 reports
MUSCLE SPASMS858 reports
NEOPLASM MALIGNANT845 reports
ASTHENIA797 reports
PYREXIA768 reports
ANAEMIA714 reports
PAIN676 reports
MALIGNANT NEOPLASM PROGRESSION666 reports
ARTHRALGIA623 reports
HEADACHE620 reports
PNEUMONIA598 reports
OEDEMA PERIPHERAL590 reports
ABDOMINAL PAIN568 reports
FALL543 reports
PLEURAL EFFUSION542 reports
HAEMOGLOBIN DECREASED530 reports
DIZZINESS517 reports
PRURITUS479 reports
GASTROINTESTINAL STROMAL TUMOUR469 reports
MYALGIA467 reports
FLUID RETENTION456 reports
PAIN IN EXTREMITY447 reports
CHRONIC MYELOID LEUKAEMIA437 reports
DECREASED APPETITE429 reports
ABDOMINAL PAIN UPPER417 reports
PLATELET COUNT DECREASED415 reports
WEIGHT DECREASED414 reports
ABDOMINAL DISCOMFORT403 reports
DRUG INTOLERANCE403 reports
WHITE BLOOD CELL COUNT DECREASED395 reports
OEDEMA388 reports
COUGH376 reports
THROMBOCYTOPENIA363 reports
WEIGHT INCREASED355 reports
BONE PAIN343 reports
CEREBROVASCULAR ACCIDENT342 reports
FEELING ABNORMAL336 reports
DISEASE PROGRESSION326 reports
SEPSIS314 reports
EYE SWELLING309 reports
NEOPLASM PROGRESSION308 reports
RENAL FAILURE307 reports
BACK PAIN303 reports
INSOMNIA302 reports
WHITE BLOOD CELL COUNT INCREASED301 reports
CONSTIPATION300 reports
DRUG INTERACTION295 reports
BLOOD CREATININE INCREASED291 reports
CHEST PAIN285 reports
PANCYTOPENIA283 reports
DEPRESSION278 reports
NEUTROPENIA274 reports
ALOPECIA268 reports
DRUG RESISTANCE267 reports
OFF LABEL USE260 reports
MYOCARDIAL INFARCTION258 reports
SWELLING258 reports
ASCITES257 reports
DEHYDRATION253 reports
SWELLING FACE250 reports
PERIPHERAL SWELLING249 reports
HYPERTENSION247 reports
PERIORBITAL OEDEMA247 reports
CARDIAC FAILURE CONGESTIVE246 reports
GAIT DISTURBANCE242 reports
HYPOACUSIS242 reports
NASOPHARYNGITIS242 reports
INFECTION232 reports
CARDIAC DISORDER231 reports
CHILLS230 reports
LEUKAEMIA224 reports
GENERAL PHYSICAL HEALTH DETERIORATION221 reports
GASTROINTESTINAL HAEMORRHAGE220 reports
ABDOMINAL DISTENSION218 reports
HYPERSENSITIVITY208 reports
ANXIETY207 reports
VISION BLURRED206 reports
MEMORY IMPAIRMENT201 reports
JOINT SWELLING200 reports
SOMNOLENCE199 reports
BLINDNESS184 reports
HAEMORRHAGE184 reports
HYPOAESTHESIA183 reports
BLAST CRISIS IN MYELOGENOUS LEUKAEMIA182 reports
ERYTHEMA180 reports
SURGERY178 reports
ATRIAL FIBRILLATION176 reports
RED BLOOD CELL COUNT DECREASED175 reports
ASPARTATE AMINOTRANSFERASE INCREASED172 reports
GASTROINTESTINAL DISORDER172 reports
METASTASES TO LIVER172 reports
CONFUSIONAL STATE170 reports

Report Outcomes

Out of 27,529 classified reports for IMATINIB MESYLATE:

Serious 75.5%Non-Serious 24.5%

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

Female12,572 (49.9%)
Male12,493 (49.6%)
Unknown108 (0.4%)

Reports by Age

Age 65281 reports
Age 60265 reports
Age 64256 reports
Age 70256 reports
Age 61254 reports
Age 72251 reports
Age 75242 reports
Age 63237 reports
Age 62236 reports
Age 69236 reports
Age 73234 reports
Age 67230 reports
Age 74228 reports
Age 71227 reports
Age 68220 reports
Age 66210 reports
Age 59208 reports
Age 57204 reports
Age 76200 reports
Age 78198 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 IMATINIB MESYLATE?

This profile reflects 47,520 FDA FAERS reports that mention IMATINIB MESYLATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for IMATINIB MESYLATE?

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

Who manufactures IMATINIB MESYLATE?

Labeling and FAERS entries often list Novartis Pharmaceuticals Corporation in connection with IMATINIB MESYLATE. 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.