IMATINIB

N/A

Manufactured by Mylan Pharmaceuticals Inc.

35,081 FDA adverse event reports analyzed

Last updated: 2026-04-14

About IMATINIB

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

Top Adverse Reactions

DRUG INEFFECTIVE1,553 reports
DRUG RESISTANCE1,027 reports
DEATH1,015 reports
DIARRHOEA983 reports
NAUSEA983 reports
DRUG INTOLERANCE863 reports
FATIGUE782 reports
MALIGNANT NEOPLASM PROGRESSION782 reports
OFF LABEL USE706 reports
VOMITING670 reports
DYSPNOEA635 reports
DISEASE PROGRESSION614 reports
PYREXIA537 reports
PLEURAL EFFUSION526 reports
ABDOMINAL PAIN504 reports
ASTHENIA504 reports
DRUG INTERACTION493 reports
HEADACHE492 reports
ANAEMIA482 reports
THROMBOCYTOPENIA482 reports
RASH477 reports
CHRONIC MYELOID LEUKAEMIA475 reports
ARTHRALGIA469 reports
PRODUCT USE IN UNAPPROVED INDICATION439 reports
MYALGIA433 reports
PRURITUS429 reports
SEPSIS414 reports
TREATMENT FAILURE414 reports
NEUTROPENIA407 reports
MALAISE401 reports
DECREASED APPETITE396 reports
DIZZINESS393 reports
TOXICITY TO VARIOUS AGENTS359 reports
MUSCLE SPASMS344 reports
ABDOMINAL PAIN UPPER340 reports
COUGH327 reports
FALL326 reports
GASTROINTESTINAL STROMAL TUMOUR320 reports
ASCITES306 reports
THERAPEUTIC RESPONSE DECREASED298 reports
INSOMNIA292 reports
CHILLS290 reports
THERAPY NON RESPONDER286 reports
GENERALISED OEDEMA274 reports
PANCYTOPENIA269 reports
BLINDNESS268 reports
CYTOGENETIC ANALYSIS ABNORMAL268 reports
PNEUMONIA267 reports
SOMNOLENCE265 reports
TACHYCARDIA264 reports
FEBRILE NEUTROPENIA259 reports
PAIN259 reports
COMA250 reports
HAEMATEMESIS244 reports
BLOOD PRESSURE INCREASED241 reports
ALTERED STATE OF CONSCIOUSNESS239 reports
HAEMORRHAGIC STROKE239 reports
BLAST CRISIS IN MYELOGENOUS LEUKAEMIA238 reports
EYE PAIN238 reports
ACUTE KIDNEY INJURY235 reports
CARDIO RESPIRATORY ARREST235 reports
CONDITION AGGRAVATED233 reports
OEDEMA PERIPHERAL233 reports
WEIGHT DECREASED232 reports
OCULAR DISCOMFORT231 reports
HAEMATURIA228 reports
HEAD DISCOMFORT227 reports
AMAUROSIS FUGAX221 reports
SECOND PRIMARY MALIGNANCY221 reports
SYNCOPE221 reports
VISION BLURRED214 reports
TINNITUS210 reports
OEDEMA206 reports
DIPLOPIA200 reports
PHILADELPHIA CHROMOSOME POSITIVE200 reports
ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT199 reports
PRESYNCOPE195 reports
URINARY TRACT DISORDER195 reports
HEPATOTOXICITY193 reports
NEOPLASM PROGRESSION192 reports
PAIN IN EXTREMITY184 reports
INFECTION182 reports
WEIGHT INCREASED176 reports
PLATELET COUNT DECREASED175 reports
PHOTOPHOBIA173 reports
CARDIAC FAILURE165 reports
RENAL FAILURE164 reports
RENAL IMPAIRMENT163 reports
FLUID RETENTION161 reports
NEOPLASM MALIGNANT161 reports
PERICARDIAL EFFUSION160 reports
ABDOMINAL DISCOMFORT157 reports
HYPERTENSION156 reports
CHRONIC GRAFT VERSUS HOST DISEASE155 reports
HAEMATOTOXICITY155 reports
HAEMOGLOBIN DECREASED147 reports
RESPIRATORY FAILURE146 reports
THERAPY INTERRUPTED146 reports
DISEASE RECURRENCE142 reports
GASTROINTESTINAL DISORDER142 reports

Report Outcomes

Out of 16,889 classified reports for IMATINIB:

Serious 89.0%Non-Serious 11.0%

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

Male7,605 (53.3%)
Female6,585 (46.1%)
Unknown91 (0.6%)

Reports by Age

Age 71260 reports
Age 69246 reports
Age 63238 reports
Age 57235 reports
Age 67233 reports
Age 62231 reports
Age 72231 reports
Age 58225 reports
Age 65221 reports
Age 60218 reports
Age 70213 reports
Age 66209 reports
Age 64206 reports
Age 52204 reports
Age 61203 reports
Age 74203 reports
Age 68202 reports
Age 77199 reports
Age 75196 reports
Age 51195 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?

This profile reflects 35,081 FDA FAERS reports that mention IMATINIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for IMATINIB?

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

Who manufactures IMATINIB?

Labeling and FAERS entries often list Mylan Pharmaceuticals Inc. in connection with IMATINIB. 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.