SORAFENIB

N/A

Manufactured by Bayer HealthCare Pharmaceuticals Inc.

51,866 FDA adverse event reports analyzed

Last updated: 2026-04-14

About SORAFENIB

SORAFENIB 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 SORAFENIB include DIARRHOEA, PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME, HEPATOCELLULAR CARCINOMA, FATIGUE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SORAFENIB.

Top Adverse Reactions

DIARRHOEA2,945 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME2,165 reports
HEPATOCELLULAR CARCINOMA1,893 reports
FATIGUE1,789 reports
OFF LABEL USE1,684 reports
RASH1,460 reports
DECREASED APPETITE1,442 reports
DEATH1,441 reports
NAUSEA1,363 reports
ASTHENIA1,184 reports
HYPERTENSION1,146 reports
PYREXIA1,059 reports
VOMITING981 reports
PAIN IN EXTREMITY966 reports
WEIGHT DECREASED915 reports
ABDOMINAL PAIN832 reports
ALOPECIA774 reports
BLISTER734 reports
DYSPNOEA716 reports
HEPATIC FUNCTION ABNORMAL663 reports
ASCITES629 reports
PRURITUS592 reports
ANAEMIA586 reports
BLOOD PRESSURE INCREASED586 reports
MALAISE586 reports
PAIN582 reports
ERYTHEMA558 reports
HEADACHE530 reports
HEPATIC FAILURE510 reports
CONSTIPATION509 reports
DRY SKIN507 reports
ABDOMINAL PAIN UPPER497 reports
SKIN EXFOLIATION486 reports
DRUG INEFFECTIVE472 reports
STOMATITIS460 reports
PLATELET COUNT DECREASED457 reports
DEHYDRATION453 reports
HEPATIC ENCEPHALOPATHY450 reports
GENERAL PHYSICAL HEALTH DETERIORATION435 reports
DYSPHONIA427 reports
MALIGNANT NEOPLASM PROGRESSION418 reports
DISEASE PROGRESSION413 reports
DIZZINESS409 reports
THROMBOCYTOPENIA397 reports
METASTASES TO LUNG396 reports
PNEUMONIA396 reports
GAIT DISTURBANCE394 reports
HEPATIC NEOPLASM MALIGNANT392 reports
CONFUSIONAL STATE389 reports
HOSPITALISATION385 reports
PRODUCT USE IN UNAPPROVED INDICATION383 reports
OEDEMA PERIPHERAL373 reports
BLOOD BILIRUBIN INCREASED334 reports
ARTHRALGIA332 reports
COUGH325 reports
ABDOMINAL DISTENSION302 reports
HEPATIC CANCER302 reports
ASPARTATE AMINOTRANSFERASE INCREASED290 reports
CHEST PAIN289 reports
EPISTAXIS278 reports
RENAL CELL CARCINOMA274 reports
ALANINE AMINOTRANSFERASE INCREASED267 reports
PLEURAL EFFUSION266 reports
PERIPHERAL SWELLING260 reports
BACK PAIN259 reports
JAUNDICE258 reports
GASTROINTESTINAL HAEMORRHAGE251 reports
RENAL FAILURE251 reports
MUSCLE SPASMS249 reports
HYPERKERATOSIS246 reports
FALL239 reports
LIVER DISORDER236 reports
HAEMOGLOBIN DECREASED234 reports
RASH GENERALISED217 reports
HYPOTENSION213 reports
PANCYTOPENIA213 reports
DRUG INTOLERANCE200 reports
INSOMNIA200 reports
PAIN OF SKIN199 reports
FEBRILE NEUTROPENIA196 reports
SEPSIS196 reports
URINARY TRACT INFECTION194 reports
MYOCARDIAL INFARCTION189 reports
NEUTROPENIA183 reports
BURNING SENSATION179 reports
MUSCULAR WEAKNESS177 reports
PULMONARY EMBOLISM177 reports
BLOOD CREATININE INCREASED176 reports
PARAESTHESIA175 reports
WHITE BLOOD CELL COUNT DECREASED175 reports
DYSPHAGIA170 reports
METASTASES TO BONE167 reports
RENAL IMPAIRMENT167 reports
SOMNOLENCE167 reports
ABDOMINAL DISCOMFORT165 reports
MUCOSAL INFLAMMATION165 reports
ORAL PAIN165 reports
ATRIAL FIBRILLATION164 reports
ABASIA163 reports
HYPOAESTHESIA163 reports

Report Outcomes

Out of 20,493 classified reports for SORAFENIB:

Serious 89.0%Non-Serious 11.0%

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

Male13,317 (70.9%)
Female5,328 (28.4%)
Unknown127 (0.7%)

Reports by Age

Age 65546 reports
Age 69534 reports
Age 67531 reports
Age 66528 reports
Age 70526 reports
Age 63520 reports
Age 61519 reports
Age 62518 reports
Age 68500 reports
Age 64494 reports
Age 60469 reports
Age 72463 reports
Age 59442 reports
Age 71423 reports
Age 74416 reports
Age 58404 reports
Age 75399 reports
Age 73392 reports
Age 76386 reports
Age 56378 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 SORAFENIB?

This profile reflects 51,866 FDA FAERS reports that mention SORAFENIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for SORAFENIB?

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

Who manufactures SORAFENIB?

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