DABRAFENIB

N/A

Manufactured by Novartis Pharmaceuticals Corporation

37,967 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DABRAFENIB

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

Top Adverse Reactions

PYREXIA4,002 reports
DEATH2,836 reports
MALIGNANT NEOPLASM PROGRESSION1,722 reports
FATIGUE1,387 reports
NAUSEA1,368 reports
CHILLS1,293 reports
RASH1,147 reports
VOMITING962 reports
DIARRHOEA943 reports
HEADACHE728 reports
ASTHENIA696 reports
MALAISE615 reports
DECREASED APPETITE575 reports
ARTHRALGIA567 reports
PRODUCT USE IN UNAPPROVED INDICATION530 reports
VISUAL IMPAIRMENT511 reports
PAIN486 reports
METASTASES TO CENTRAL NERVOUS SYSTEM481 reports
DRUG INEFFECTIVE474 reports
METASTATIC MALIGNANT MELANOMA470 reports
MALIGNANT MELANOMA433 reports
DISEASE PROGRESSION409 reports
DYSPNOEA404 reports
DIZZINESS372 reports
COUGH351 reports
PNEUMONIA342 reports
DEHYDRATION341 reports
GENERAL PHYSICAL HEALTH DETERIORATION331 reports
VISION BLURRED326 reports
CONSTIPATION316 reports
OFF LABEL USE313 reports
WEIGHT DECREASED310 reports
HYPOTENSION300 reports
DYSPHAGIA296 reports
PRURITUS286 reports
MYALGIA283 reports
PAIN IN EXTREMITY279 reports
PERIPHERAL SWELLING266 reports
ABDOMINAL PAIN256 reports
UVEITIS255 reports
ANAEMIA252 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED246 reports
SEIZURE227 reports
CONFUSIONAL STATE223 reports
EJECTION FRACTION DECREASED223 reports
ACUTE KIDNEY INJURY220 reports
INFECTION218 reports
FALL213 reports
NEUTROPENIA212 reports
NEOPLASM MALIGNANT207 reports
TREMOR207 reports
URINARY TRACT INFECTION204 reports
ASPARTATE AMINOTRANSFERASE INCREASED195 reports
ALOPECIA193 reports
ERYTHEMA193 reports
THROMBOCYTOPENIA193 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION190 reports
C REACTIVE PROTEIN INCREASED187 reports
DRY SKIN184 reports
SEPSIS182 reports
ALANINE AMINOTRANSFERASE INCREASED180 reports
DRUG INTOLERANCE175 reports
OEDEMA PERIPHERAL174 reports
BACK PAIN170 reports
RENAL FAILURE169 reports
ABDOMINAL PAIN UPPER166 reports
PULMONARY EMBOLISM164 reports
INCORRECT DOSE ADMINISTERED162 reports
GAIT DISTURBANCE161 reports
ABDOMINAL DISCOMFORT159 reports
HYPERHIDROSIS158 reports
ILLNESS151 reports
HEPATIC ENZYME INCREASED150 reports
METASTASES TO LUNG150 reports
RHABDOMYOLYSIS144 reports
HYPERTENSION141 reports
SYNCOPE140 reports
METASTASES TO LIVER139 reports
FEELING ABNORMAL133 reports
PANNICULITIS133 reports
PRODUCT USE ISSUE130 reports
SOMNOLENCE130 reports
HOSPITALISATION127 reports
PNEUMONITIS127 reports
ATRIAL FIBRILLATION126 reports
INFLUENZA LIKE ILLNESS126 reports
CARDIAC FAILURE125 reports
BLOOD LACTATE DEHYDROGENASE INCREASED123 reports
JOINT SWELLING122 reports
SECOND PRIMARY MALIGNANCY122 reports
LYMPHADENOPATHY121 reports
NASOPHARYNGITIS120 reports
CONDITION AGGRAVATED119 reports
HYPERSENSITIVITY119 reports
PRODUCT STORAGE ERROR117 reports
HYPONATRAEMIA115 reports
HEPATITIS113 reports
BASAL CELL CARCINOMA112 reports
OEDEMA112 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME111 reports

Report Outcomes

Out of 20,468 classified reports for DABRAFENIB:

Serious 74.1%Non-Serious 25.9%

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

Male9,761 (53.0%)
Female8,623 (46.8%)
Unknown25 (0.1%)

Reports by Age

Age 64324 reports
Age 70313 reports
Age 60312 reports
Age 63311 reports
Age 66307 reports
Age 67306 reports
Age 68303 reports
Age 62302 reports
Age 65301 reports
Age 59290 reports
Age 61287 reports
Age 57285 reports
Age 69281 reports
Age 58262 reports
Age 72260 reports
Age 73251 reports
Age 76246 reports
Age 71238 reports
Age 55234 reports
Age 56233 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 DABRAFENIB?

This profile reflects 37,967 FDA FAERS reports that mention DABRAFENIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DABRAFENIB?

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

Who manufactures DABRAFENIB?

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