ENCORAFENIB

N/A

Manufactured by Array BioPharma Inc.

16,241 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ENCORAFENIB

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

Top Adverse Reactions

OFF LABEL USE1,084 reports
DEATH1,082 reports
NAUSEA804 reports
FATIGUE726 reports
DIARRHOEA603 reports
PYREXIA572 reports
NEOPLASM PROGRESSION551 reports
PRODUCT USE IN UNAPPROVED INDICATION519 reports
VOMITING446 reports
RASH440 reports
SEROUS RETINAL DETACHMENT325 reports
ARTHRALGIA296 reports
DECREASED APPETITE280 reports
MALAISE280 reports
ASTHENIA230 reports
DISEASE PROGRESSION227 reports
PAIN218 reports
VISION BLURRED214 reports
ACUTE KIDNEY INJURY208 reports
MALIGNANT NEOPLASM PROGRESSION208 reports
CONSTIPATION207 reports
HEADACHE190 reports
VISUAL IMPAIRMENT187 reports
ABDOMINAL PAIN180 reports
ANAEMIA172 reports
PRURITUS158 reports
MYALGIA154 reports
DYSPNOEA150 reports
DEHYDRATION138 reports
COLITIS134 reports
CHILLS128 reports
WEIGHT DECREASED125 reports
DIZZINESS122 reports
SECOND PRIMARY MALIGNANCY120 reports
RENAL IMPAIRMENT118 reports
DRUG INEFFECTIVE112 reports
ILLNESS112 reports
DYSPHAGIA111 reports
PRODUCT USE ISSUE111 reports
ABDOMINAL PAIN UPPER104 reports
HYPOTENSION104 reports
PAIN IN EXTREMITY102 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED100 reports
NEUROPATHY PERIPHERAL95 reports
ALOPECIA94 reports
SEIZURE93 reports
RETINAL DETACHMENT92 reports
ALANINE AMINOTRANSFERASE INCREASED87 reports
BLOOD CREATININE INCREASED87 reports
ABDOMINAL DISCOMFORT86 reports
BACK PAIN86 reports
LIVER DISORDER85 reports
URINARY TRACT INFECTION85 reports
ASPARTATE AMINOTRANSFERASE INCREASED83 reports
PNEUMONIA83 reports
RENAL FAILURE81 reports
PERIPHERAL SWELLING80 reports
FALL78 reports
GENERAL PHYSICAL HEALTH DETERIORATION77 reports
UVEITIS77 reports
HEPATIC FUNCTION ABNORMAL75 reports
MUSCLE SPASMS75 reports
INSOMNIA72 reports
DRY SKIN71 reports
COVID 1969 reports
HOSPICE CARE69 reports
HYPERTENSION69 reports
CONDITION AGGRAVATED68 reports
THERAPY INTERRUPTED68 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME67 reports
SEPSIS67 reports
HEPATIC ENZYME INCREASED65 reports
PRODUCT DOSE OMISSION ISSUE65 reports
COUGH64 reports
CONFUSIONAL STATE63 reports
PRODUCT DOSE OMISSION63 reports
DERMATITIS ACNEIFORM62 reports
DRUG INTOLERANCE60 reports
HYPERSENSITIVITY59 reports
HYPOACUSIS59 reports
MELANOCYTIC NAEVUS59 reports
ERYTHEMA57 reports
SEROUS RETINOPATHY55 reports
SOMNOLENCE54 reports
INFECTION53 reports
MEMORY IMPAIRMENT52 reports
RASH MACULO PAPULAR52 reports
MALIGNANT MELANOMA51 reports
RENAL DISORDER51 reports
ACNE50 reports
HEPATITIS50 reports
INTERSTITIAL LUNG DISEASE50 reports
MUSCULAR WEAKNESS49 reports
PANCREATITIS49 reports
CEREBROVASCULAR ACCIDENT47 reports
EYE DISORDER47 reports
INTESTINAL OBSTRUCTION47 reports
PLATELET COUNT DECREASED46 reports
THROMBOCYTOPENIA46 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED45 reports

Report Outcomes

Out of 9,235 classified reports for ENCORAFENIB:

Serious 69.0%Non-Serious 31.0%

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

Male3,428 (50.5%)
Female3,354 (49.5%)

Reports by Age

Age 70200 reports
Age 72200 reports
Age 65199 reports
Age 66191 reports
Age 74180 reports
Age 75177 reports
Age 69175 reports
Age 71169 reports
Age 73169 reports
Age 67168 reports
Age 64167 reports
Age 68161 reports
Age 76159 reports
Age 58145 reports
Age 77142 reports
Age 61141 reports
Age 60140 reports
Age 63139 reports
Age 62134 reports
Age 80117 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 ENCORAFENIB?

This profile reflects 16,241 FDA FAERS reports that mention ENCORAFENIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ENCORAFENIB?

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

Who manufactures ENCORAFENIB?

Labeling and FAERS entries often list Array BioPharma Inc. in connection with ENCORAFENIB. 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.