REGORAFENIB

N/A

Manufactured by Bayer HealthCare Pharmaceuticals Inc.

34,211 FDA adverse event reports analyzed

Last updated: 2026-04-14

About REGORAFENIB

REGORAFENIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bayer HealthCare Pharmaceuticals Inc.. The most commonly reported adverse reactions for REGORAFENIB include OFF LABEL USE, FATIGUE, PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME, DIARRHOEA, DECREASED APPETITE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for REGORAFENIB.

Top Adverse Reactions

OFF LABEL USE2,051 reports
FATIGUE1,749 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME1,429 reports
DIARRHOEA1,402 reports
DECREASED APPETITE1,082 reports
DEATH981 reports
ASTHENIA937 reports
DYSPHONIA819 reports
NAUSEA807 reports
PAIN IN EXTREMITY768 reports
PYREXIA747 reports
HYPERTENSION688 reports
WEIGHT DECREASED631 reports
VOMITING566 reports
RASH551 reports
PAIN529 reports
NEUROPATHY PERIPHERAL499 reports
HEPATOCELLULAR CARCINOMA484 reports
ABDOMINAL PAIN472 reports
DYSPNOEA461 reports
DEHYDRATION456 reports
BLISTER454 reports
BLOOD PRESSURE INCREASED450 reports
DRUG INEFFECTIVE430 reports
HEADACHE429 reports
CONSTIPATION421 reports
MALAISE409 reports
ABDOMINAL PAIN UPPER369 reports
SKIN EXFOLIATION354 reports
GAIT DISTURBANCE349 reports
COLON CANCER343 reports
STOMATITIS338 reports
METASTASES TO LUNG322 reports
COLORECTAL CANCER METASTATIC314 reports
HOSPITALISATION308 reports
ERYTHEMA296 reports
COLORECTAL CANCER285 reports
DISEASE PROGRESSION281 reports
METASTASES TO LIVER276 reports
BACK PAIN275 reports
PLATELET COUNT DECREASED266 reports
BLOOD BILIRUBIN INCREASED263 reports
DRY SKIN262 reports
GENERAL PHYSICAL HEALTH DETERIORATION260 reports
DIZZINESS250 reports
PERIPHERAL SWELLING227 reports
ARTHRALGIA219 reports
PNEUMONIA212 reports
COUGH211 reports
ASCITES209 reports
MUSCLE SPASMS199 reports
ANAEMIA191 reports
CONFUSIONAL STATE187 reports
MALIGNANT NEOPLASM PROGRESSION187 reports
HEPATIC FUNCTION ABNORMAL185 reports
PRODUCT USE IN UNAPPROVED INDICATION179 reports
HYPOAESTHESIA177 reports
DRY MOUTH171 reports
ORAL PAIN171 reports
ASPARTATE AMINOTRANSFERASE INCREASED168 reports
ALOPECIA166 reports
CHEST PAIN159 reports
MUCOSAL INFLAMMATION156 reports
PRURITUS154 reports
URINARY TRACT INFECTION154 reports
THROMBOCYTOPENIA153 reports
ADVERSE DRUG REACTION149 reports
HYPERKERATOSIS148 reports
JAUNDICE148 reports
OROPHARYNGEAL PAIN146 reports
PRODUCT USE ISSUE146 reports
ALANINE AMINOTRANSFERASE INCREASED144 reports
SEPSIS144 reports
FALL143 reports
PARAESTHESIA143 reports
MYALGIA141 reports
ABDOMINAL DISTENSION138 reports
OEDEMA PERIPHERAL138 reports
GAIT INABILITY137 reports
DRUG INTOLERANCE136 reports
MYELOSUPPRESSION134 reports
HEPATIC FAILURE132 reports
INSOMNIA132 reports
GASTROINTESTINAL STROMAL TUMOUR129 reports
EPISTAXIS128 reports
DYSPHAGIA117 reports
SKIN FISSURES116 reports
BURNING SENSATION115 reports
RENAL IMPAIRMENT114 reports
CHILLS112 reports
FEELING ABNORMAL108 reports
LIVER DISORDER108 reports
MOBILITY DECREASED108 reports
HYPOTENSION106 reports
MUSCULAR WEAKNESS105 reports
ABDOMINAL DISCOMFORT102 reports
CARCINOEMBRYONIC ANTIGEN INCREASED101 reports
SOMNOLENCE99 reports
ACUTE KIDNEY INJURY98 reports
RECTAL CANCER98 reports

Report Outcomes

Out of 11,360 classified reports for REGORAFENIB:

Serious 90.1%Non-Serious 9.9%

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

Male6,257 (59.9%)
Female4,122 (39.5%)
Unknown69 (0.7%)

Reports by Age

Age 64331 reports
Age 67319 reports
Age 62317 reports
Age 63315 reports
Age 65308 reports
Age 70305 reports
Age 68289 reports
Age 66277 reports
Age 72267 reports
Age 69264 reports
Age 61261 reports
Age 58260 reports
Age 59259 reports
Age 71248 reports
Age 57243 reports
Age 60242 reports
Age 73217 reports
Age 56211 reports
Age 55208 reports
Age 75198 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 REGORAFENIB?

This profile reflects 34,211 FDA FAERS reports that mention REGORAFENIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for REGORAFENIB?

Frequently reported terms in FAERS include OFF LABEL USE, FATIGUE, PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME, DIARRHOEA, DECREASED APPETITE, DEATH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures REGORAFENIB?

Labeling and FAERS entries often list Bayer HealthCare Pharmaceuticals Inc. in connection with REGORAFENIB. 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.