BINIMETINIB

N/A

Manufactured by Array BioPharma Inc.

13,446 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BINIMETINIB

BINIMETINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Array BioPharma Inc.. The most commonly reported adverse reactions for BINIMETINIB 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 BINIMETINIB.

Top Adverse Reactions

OFF LABEL USE950 reports
DEATH773 reports
NAUSEA688 reports
FATIGUE583 reports
DIARRHOEA547 reports
PRODUCT USE IN UNAPPROVED INDICATION520 reports
PYREXIA519 reports
NEOPLASM PROGRESSION393 reports
VOMITING390 reports
RASH381 reports
SEROUS RETINAL DETACHMENT324 reports
MALAISE217 reports
ARTHRALGIA214 reports
DECREASED APPETITE207 reports
VISION BLURRED204 reports
DISEASE PROGRESSION200 reports
VISUAL IMPAIRMENT172 reports
CONSTIPATION169 reports
MALIGNANT NEOPLASM PROGRESSION167 reports
ACUTE KIDNEY INJURY165 reports
ASTHENIA163 reports
PAIN152 reports
ANAEMIA142 reports
HEADACHE139 reports
COLITIS133 reports
ABDOMINAL PAIN132 reports
DYSPNOEA132 reports
MYALGIA127 reports
PRURITUS123 reports
CHILLS110 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED109 reports
DEHYDRATION104 reports
DIZZINESS103 reports
RENAL IMPAIRMENT96 reports
HYPOTENSION93 reports
DRUG INEFFECTIVE91 reports
SEIZURE90 reports
ABDOMINAL PAIN UPPER89 reports
ALANINE AMINOTRANSFERASE INCREASED89 reports
WEIGHT DECREASED88 reports
RETINAL DETACHMENT86 reports
LIVER DISORDER82 reports
ALOPECIA81 reports
ASPARTATE AMINOTRANSFERASE INCREASED81 reports
BLOOD CREATININE INCREASED80 reports
URINARY TRACT INFECTION79 reports
PRODUCT USE ISSUE76 reports
ABDOMINAL DISCOMFORT75 reports
SECOND PRIMARY MALIGNANCY75 reports
HEPATIC FUNCTION ABNORMAL74 reports
ILLNESS71 reports
PAIN IN EXTREMITY71 reports
PNEUMONIA71 reports
DYSPHAGIA69 reports
PERIPHERAL SWELLING69 reports
HYPERTENSION68 reports
CONFUSIONAL STATE67 reports
RENAL FAILURE67 reports
PRODUCT DOSE OMISSION65 reports
HEPATIC ENZYME INCREASED63 reports
UVEITIS63 reports
BACK PAIN61 reports
FALL61 reports
MUSCLE SPASMS59 reports
NEUROPATHY PERIPHERAL59 reports
DRY SKIN57 reports
SEROUS RETINOPATHY57 reports
GENERAL PHYSICAL HEALTH DETERIORATION55 reports
MUSCULAR WEAKNESS54 reports
PNEUMONITIS52 reports
SEPSIS52 reports
COVID 1951 reports
DRUG INTOLERANCE51 reports
HEPATITIS50 reports
COUGH49 reports
RASH MACULO PAPULAR49 reports
CONDITION AGGRAVATED47 reports
DERMATITIS ACNEIFORM47 reports
RENAL DISORDER47 reports
PRODUCT DOSE OMISSION ISSUE46 reports
RETINOPATHY46 reports
EYE DISORDER44 reports
HEPATIC CYTOLYSIS44 reports
INTERSTITIAL LUNG DISEASE44 reports
MACULAR OEDEMA44 reports
METASTASES TO CENTRAL NERVOUS SYSTEM44 reports
MEMORY IMPAIRMENT42 reports
INSOMNIA41 reports
OEDEMA PERIPHERAL41 reports
SOMNOLENCE41 reports
LIVER FUNCTION TEST INCREASED40 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME40 reports
TUMOUR LYSIS SYNDROME40 reports
EJECTION FRACTION DECREASED39 reports
HOSPICE CARE39 reports
HYPERSENSITIVITY39 reports
THERAPY INTERRUPTED39 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED38 reports
HYPOTHYROIDISM38 reports
MALIGNANT MELANOMA38 reports

Report Outcomes

Out of 7,380 classified reports for BINIMETINIB:

Serious 68.7%Non-Serious 31.3%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Frequently Asked Questions

How many FDA adverse event reports are associated with BINIMETINIB?

This profile reflects 13,446 FDA FAERS reports that mention BINIMETINIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BINIMETINIB?

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

Who manufactures BINIMETINIB?

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