TRAMETINIB

N/A

Manufactured by Novartis Pharmaceuticals Corporation

42,856 FDA adverse event reports analyzed

Last updated: 2026-04-14

About TRAMETINIB

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

Top Adverse Reactions

PYREXIA3,960 reports
DEATH3,344 reports
MALIGNANT NEOPLASM PROGRESSION1,991 reports
RASH1,675 reports
FATIGUE1,470 reports
NAUSEA1,447 reports
CHILLS1,252 reports
DIARRHOEA1,246 reports
PRODUCT USE IN UNAPPROVED INDICATION1,074 reports
VOMITING1,033 reports
HEADACHE742 reports
ASTHENIA709 reports
OFF LABEL USE701 reports
MALAISE646 reports
DRUG INEFFECTIVE630 reports
VISUAL IMPAIRMENT590 reports
DECREASED APPETITE583 reports
ARTHRALGIA537 reports
PAIN491 reports
DISEASE PROGRESSION486 reports
METASTATIC MALIGNANT MELANOMA477 reports
METASTASES TO CENTRAL NERVOUS SYSTEM475 reports
DYSPNOEA466 reports
MALIGNANT MELANOMA429 reports
PNEUMONIA412 reports
DEHYDRATION391 reports
DIZZINESS373 reports
COUGH358 reports
VISION BLURRED357 reports
CONSTIPATION355 reports
GENERAL PHYSICAL HEALTH DETERIORATION350 reports
PRURITUS334 reports
WEIGHT DECREASED321 reports
PRODUCT STORAGE ERROR317 reports
PERIPHERAL SWELLING312 reports
HYPOTENSION310 reports
ANAEMIA309 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED309 reports
ABDOMINAL PAIN306 reports
MYALGIA272 reports
PAIN IN EXTREMITY272 reports
DRY SKIN270 reports
DYSPHAGIA262 reports
EJECTION FRACTION DECREASED249 reports
ACNE245 reports
INFECTION244 reports
CONFUSIONAL STATE237 reports
SEIZURE237 reports
URINARY TRACT INFECTION234 reports
ALOPECIA231 reports
UVEITIS230 reports
ERYTHEMA228 reports
NEOPLASM MALIGNANT227 reports
SEPSIS226 reports
ACUTE KIDNEY INJURY223 reports
FALL219 reports
PRODUCT USE ISSUE219 reports
NEUTROPENIA218 reports
ASPARTATE AMINOTRANSFERASE INCREASED217 reports
TREMOR209 reports
OEDEMA PERIPHERAL208 reports
C REACTIVE PROTEIN INCREASED207 reports
THROMBOCYTOPENIA202 reports
ALANINE AMINOTRANSFERASE INCREASED200 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION192 reports
ABDOMINAL PAIN UPPER191 reports
DRUG INTOLERANCE189 reports
HYPERTENSION189 reports
PULMONARY EMBOLISM183 reports
ILLNESS173 reports
INCORRECT DOSE ADMINISTERED173 reports
ABDOMINAL DISCOMFORT172 reports
BACK PAIN172 reports
GAIT DISTURBANCE172 reports
DERMATITIS ACNEIFORM171 reports
HEPATIC ENZYME INCREASED163 reports
RENAL FAILURE163 reports
STOMATITIS160 reports
METASTASES TO LUNG156 reports
METASTASES TO LIVER153 reports
RHABDOMYOLYSIS148 reports
SYNCOPE148 reports
HYPERHIDROSIS146 reports
OEDEMA146 reports
PNEUMONITIS141 reports
HYPERSENSITIVITY140 reports
CARDIAC FAILURE139 reports
FEELING ABNORMAL137 reports
SOMNOLENCE136 reports
JOINT SWELLING135 reports
NEOPLASM PROGRESSION135 reports
ATRIAL FIBRILLATION134 reports
HYPONATRAEMIA134 reports
PLEURAL EFFUSION133 reports
PLATELET COUNT DECREASED132 reports
EPISTAXIS131 reports
INFLUENZA LIKE ILLNESS131 reports
BLOOD LACTATE DEHYDROGENASE INCREASED129 reports
HOSPITALISATION128 reports
PANNICULITIS127 reports

Report Outcomes

Out of 23,390 classified reports for TRAMETINIB:

Serious 72.6%Non-Serious 27.4%

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

Male10,695 (51.1%)
Female10,227 (48.8%)
Unknown28 (0.1%)

Reports by Age

Age 64366 reports
Age 70346 reports
Age 68340 reports
Age 60337 reports
Age 65333 reports
Age 63330 reports
Age 66325 reports
Age 67324 reports
Age 59319 reports
Age 62316 reports
Age 61313 reports
Age 69310 reports
Age 58293 reports
Age 57290 reports
Age 71283 reports
Age 73265 reports
Age 56259 reports
Age 76256 reports
Age 54250 reports
Age 72249 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 TRAMETINIB?

This profile reflects 42,856 FDA FAERS reports that mention TRAMETINIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TRAMETINIB?

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

Who manufactures TRAMETINIB?

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