About this FactMed analysis covering adverse side effect reports of SORAFENIB (RAF KINASE INHIBITOR) patients who developed DEATH.

FactMed provides MD-approved analysis to help both patients, researchers, and physicians accurately assess the risk profile for more than 20,000 different pharmaceutical products. The below report offers compiled information from Food & Drug Administration and FactMed user submissions. Between January 2004 and October 2012, 113 individuals taking SORAFENIB (RAF KINASE INHIBITOR) reported DEATH to the FDA. A total of 3329 SORAFENIB (RAF KINASE INHIBITOR) drug adverse event reaction reports were made with the FDA during this time period. Often the FDA only receives reports of the most critical and severe cases; these numbers may therefore underrepresent the complication rate of the medication.

FDA Research Report

Introduction This page is designed to help you determine the relationship, if any, between SORAFENIB (RAF KINASE INHIBITOR) and DEATH. In doing so, we compare SORAFENIB (RAF KINASE INHIBITOR) with other drugs that cause DEATH, to help you evaluate whether or not SORAFENIB (RAF KINASE INHIBITOR) causes DEATH. Likewise, this page shows the most highly-reported side effects of SORAFENIB (RAF KINASE INHIBITOR), so you can see if DEATH ranks among SORAFENIB (RAF KINASE INHIBITOR)'s most well-known side effects.
Summary Statistics
Reports of SORAFENIB (RAF KINASE INHIBITOR) causing DEATH: 113
Reports of any side effect of SORAFENIB (RAF KINASE INHIBITOR) : 3329
Percentage of SORAFENIB (RAF KINASE INHIBITOR) patients where DEATH is a reported side effect: 3.3944%

FDA reports of any drug causing DEATH : 157069
Average percentage for all medicated patients where DEATH is reported as a complication: 0.9844%

Physician opinion on SORAFENIB (RAF KINASE INHIBITOR) as adverse event culprit:

Overall opinion for all reports of this drug:
Most frequent diagnoses/indications for prescribing SORAFENIB (RAF KINASE INHIBITOR):
HEPATIC NEOPLASM MALIGNANT ( 770 patients )
RENAL CELL CARCINOMA ( 114 patients )
THYROID CANCER ( 65 patients )
METASTATIC RENAL CELL CARCINOMA ( 44 patients )
THYROID CANCER METASTATIC ( 35 patients )
BREAST CANCER ( 31 patients )
BREAST CANCER METASTATIC ( 27 patients )
GASTRIC CANCER ( 25 patients )
NON-SMALL CELL LUNG CANCER ( 25 patients )
COLORECTAL CANCER METASTATIC ( 22 patients )
RENAL CANCER ( 17 patients )
PRODUCT USED FOR UNKNOWN INDICATION ( 14 patients )
BILE DUCT CANCER ( 14 patients )
SALIVARY GLAND CANCER ( 7 patients )
HEPATIC CANCER METASTATIC ( 7 patients )
COLORECTAL CANCER ( 7 patients )
SMALL CELL LUNG CANCER STAGE UNSPECIFIED ( 6 patients )
RECTAL CANCER ( 5 patients )
PANCREATIC CARCINOMA ( 4 patients )
PROSTATE CANCER ( 4 patients )
INTRAOCULAR MELANOMA ( 4 patients )
HEPATIC NEOPLASM MALIGNANT RECURRENT ( 3 patients )
NEOPLASM ( 3 patients )
LIVER DISORDER ( 3 patients )
ANGIOSARCOMA ( 3 patients )
NON-SMALL CELL LUNG CANCER STAGE IV ( 3 patients )
METASTASES TO LUNG ( 3 patients )
HEPATIC NEOPLASM MALIGNANT NON-RESECTABLE ( 3 patients )
COLORECTAL CANCER STAGE IV ( 3 patients )
NEOPLASM MALIGNANT ( 3 patients )
GALLBLADDER CANCER METASTATIC ( 3 patients )
BILIARY CANCER METASTATIC ( 3 patients )
METASTASIS ( 3 patients )
COLON CANCER METASTATIC ( 2 patients )
HYPOPHARYNGEAL CANCER ( 2 patients )
DESMOID TUMOUR ( 2 patients )
NEUROENDOCRINE CARCINOMA ( 2 patients )
ACUTE MYELOID LEUKAEMIA (IN REMISSION) ( 2 patients )
LUNG NEOPLASM MALIGNANT ( 2 patients )
OESOPHAGEAL CARCINOMA ( 2 patients )
METASTATIC MALIGNANT MELANOMA ( 2 patients )
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED ( 2 patients )
METASTATIC SQUAMOUS CELL CARCINOMA ( 2 patients )
ANGINA PECTORIS ( 2 patients )
RENAL CELL CARCINOMA STAGE IV ( 2 patients )
OSTEOSARCOMA METASTATIC ( 2 patients )
BONE SARCOMA ( 2 patients )
METASTATIC OCULAR MELANOMA ( 2 patients )
METASTATIC SALIVARY GLAND CANCER ( 2 patients )
TONSIL CANCER ( 2 patients )
MYELODYSPLASTIC SYNDROME ( 1 patients )
PROSTATE CANCER METASTATIC ( 1 patients )
GALLBLADDER CANCER ( 1 patients )
NEUROENDOCRINE TUMOUR ( 1 patients )
MALIGNANT NEOPLASM OF RENAL PELVIS ( 1 patients )
GLIOMA ( 1 patients )
BLADDER CANCER ( 1 patients )
OVARIAN CANCER METASTATIC ( 1 patients )
CAROTID ARTERY DISEASE ( 1 patients )
HEPATOBLASTOMA ( 1 patients )
NASOPHARYNGEAL CANCER ( 1 patients )
ACUTE MYELOID LEUKAEMIA ( 1 patients )
LUNG ADENOCARCINOMA ( 1 patients )
RENAL CANCER METASTATIC ( 1 patients )
DIFFUSE LARGE B-CELL LYMPHOMA ( 1 patients )
NEUROENDOCRINE CARCINOMA OF THE SKIN ( 1 patients )
MALIGNANT HISTIOCYTOSIS ( 1 patients )
ANTICOAGULANT THERAPY ( 1 patients )
MALIGNANT SOFT TISSUE NEOPLASM ( 1 patients )
SARCOMA ( 1 patients )
GERM CELL CANCER ( 1 patients )
OESOPHAGEAL ADENOCARCINOMA ( 1 patients )
SQUAMOUS CELL CARCINOMA ( 1 patients )
HEAD AND NECK CANCER ( 1 patients )
OVARIAN EPITHELIAL CANCER ( 1 patients )
( 0 patients )
Drugs with high FDA adverse event association with DEATH:

REVLIMID (9475 patients)
DIANEAL (6739 patients)
TRASYLOL (6596 patients)
TRACLEER (5718 patients)
AVANDIA (5236 patients)
THALOMID (5161 patients)
VIOXX (4842 patients)
EXJADE (4630 patients)
ASPIRIN (4029 patients)
GLEEVEC (3904 patients)
ZOMETA (3699 patients)
SEROQUEL (3295 patients)
LASIX (3257 patients)
LIPITOR (3164 patients)
LETAIRIS (3012 patients)
SUTENT (2787 patients)
COUMADIN (2609 patients)
AVONEX (2603 patients)
REVATIO (2391 patients)
FORTEO (2192 patients)
PLAVIX (2146 patients)
EXTRANEAL (2106 patients)
DEXAMETHASONE (2036 patients)
OXYCONTIN (2014 patients)
AVASTIN (2011 patients)
PREDNISONE (1996 patients)
REMODULIN (1993 patients)
FUROSEMIDE (1947 patients)
HEPARIN (1918 patients)
XELODA (1904 patients)
ZOLEDRONOC ACID (1853 patients)
LUCENTIS (1830 patients)
REMICADE (1821 patients)
CLOZARIL (1741 patients)
CLOZAPINE (1726 patients)
FOSAMAX (1691 patients)
DIGOXIN (1686 patients)
LISINOPRIL (1665 patients)
HEPARIN SODIUM INJECTION (1637 patients)
ACETAMINOPHEN (1609 patients)
BOSENTAN TABLET UNKNOWN US MG (1548 patients)
NORVASC (1468 patients)
ZYPREXA (1432 patients)
OMEPRAZOLE (1429 patients)
NEXIUM (1414 patients)
TARCEVA (1398 patients)
VELCADE (1360 patients)
NPLATE (1338 patients)
DIOVAN (1330 patients)
FOLIC ACID (1285 patients)
SANDOSTATIN LAR (1264 patients)
EXELON (1250 patients)
ERLOTINIB HYDROCHLORIDE (1177 patients)
METHOTREXATE (1177 patients)
CAPECITABINE (1163 patients)
FENTANYL (1146 patients)
CELEBREX (1131 patients)
LYRICA (1129 patients)
NITROGLYCERIN (1116 patients)
POTASSIUM CHLORIDE (1112 patients)
RECLAST (1104 patients)
MORPHINE (1089 patients)
ATENOLOL (1089 patients)
SIMVASTATIN (1078 patients)
INSULIN (1075 patients)
SPIRIVA (1068 patients)
HUMIRA (1058 patients)
SYNTHROID (1056 patients)
RISPERDAL (1054 patients)
CYCLOPHOSPHAMIDE (1035 patients)
PRADAXA (987 patients)
ALBUTEROL (982 patients)
LANTUS (980 patients)
OXYCODONE HCL (976 patients)
PREDNISOLONE (951 patients)
ZOCOR (942 patients)
ADVAIR DISKUS 100/50 (936 patients)
ALLOPURINOL (936 patients)
LORAZEPAM (921 patients)
AREDIA (910 patients)
PROTONIX (902 patients)
ALPRAZOLAM (892 patients)
WARFARIN SODIUM (880 patients)
ZOLOFT (876 patients)
NEURONTIN (868 patients)
PRILOSEC (854 patients)
METOPROLOL TARTRATE (850 patients)
PROGRAF (849 patients)
LEVOTHYROXINE SODIUM (843 patients)
BEVACIZUMAB (833 patients)
VANCOMYCIN (830 patients)
METFORMIN HCL (822 patients)
HYDROCHLOROTHIAZIDE (820 patients)
ACETYLSALICYLIC ACID SRT (819 patients)
PREDNISONE TAB (816 patients)
RED BLOOD CELLS (814 patients)
DECADRON (806 patients)
PROTAMINE SULFATE (804 patients)
DURAGESIC-100 (800 patients)
MORPHINE SULFATE (795 patients)
GABAPENTIN (790 patients)
AFINITOR (788 patients)
TOPROL-XL (787 patients)
FLUOROURACIL (785 patients)
RITUXIMAB (781 patients)
NEXAVAR (771 patients)
ATIVAN (770 patients)
ZOFRAN (770 patients)
VITAMIN D (769 patients)
AMBIEN (769 patients)
CARBOPLATIN (766 patients)
CLONAZEPAM (766 patients)
COREG (752 patients)
XANAX (751 patients)
IBANDRONIC ACID (746 patients)
CISPLATIN (740 patients)
TYSABRI (733 patients)
ACLASTA (729 patients)
ENBREL (718 patients)
DIAZEPAM (697 patients)
CYMBALTA (687 patients)
OXALIPLATIN (686 patients)
VENTAVIS (685 patients)
LOVENOX (684 patients)
IBUPROFEN (681 patients)
AMLODIPINE (674 patients)
LEVAQUIN (658 patients)
GEMZAR (637 patients)
SPIRONOLACTONE (619 patients)
PAXIL (618 patients)
ARANESP (617 patients)
VERSED (612 patients)
VIDAZA (611 patients)
CORTICOSTEROIDS (601 patients)
PROCRIT (601 patients)
TACROLIMUS (599 patients)
ROSIGLITAZONE MALEATE (593 patients)
OXYGEN (586 patients)
PREVACID (581 patients)
TEMAZEPAM (576 patients)
PLATELETS (572 patients)
LEXAPRO (558 patients)
BETASERON (558 patients)
TRAMADOL HCL (553 patients)
TAXOTERE (550 patients)
VICODIN (542 patients)
CRESTOR (541 patients)
METOPROLOL (539 patients)
ACYCLOVIR (538 patients)
DIANEAL PD-2 W/ DEXTROSE 1.5% (537 patients)
GLUCOPHAGE (535 patients)
PERCOCET (529 patients)
CALCIUM (529 patients)
TYKERB (523 patients)
MULTI-VITAMINS (519 patients)
DIOVAN HCT (510 patients)
VFEND (510 patients)
AMIODARONE HCL (509 patients)
DOXORUBICIN HCL (509 patients)
LOPRESSOR (503 patients)
BONIVA (495 patients)
MYCOPHENOLATE MOFETIL (493 patients)
FEMARA (492 patients)
CLONIDINE (492 patients)
ATROVENT (491 patients)
ALDACTONE (490 patients)
MEGACE (490 patients)
TAXOL (487 patients)
VITAMIN B-12 (485 patients)
PEGASYS (474 patients)
LIDOCAINE (465 patients)
ABILIFY (464 patients)
EPINEPHRINE (463 patients)
SUNITINIB MALATE (460 patients)
VIAGRA (460 patients)
GLIPIZIDE (455 patients)
METHADONE HCL (453 patients)
FLUCONAZOLE (450 patients)
TASIGNA (448 patients)
DILAUDID (446 patients)
LANSOPRAZOLE (445 patients)
PANTOPRAZOLE (445 patients)
LANOXIN (444 patients)
CALCIUM CHANNEL BLOCKERS (442 patients)
DOPAMINE HCL (442 patients)
METOCLOPRAMIDE (434 patients)
IMATINIB MESYLATE (433 patients)
RAMIPRIL (433 patients)
CYCLOSPORINE (431 patients)
PROMACTA (428 patients)
LIORESAL (425 patients)
DOCETAXEL (424 patients)
ALIMTA (423 patients)
TOBI (421 patients)
LACTULOSE (419 patients)
FLOMAX (418 patients)
DIPHENHYDRAMINE HCL (416 patients)
VINCRISTINE (416 patients)
ACTIVASE (412 patients)
NEUPOGEN (411 patients)
RANIBIZUMAB (411 patients)
ETOPOSIDE (408 patients)
TRAZODONE HCL (407 patients)
MABTHERA (406 patients)
MANNITOL (406 patients)
COZAAR (405 patients)
GLYBURIDE (405 patients)
BENADRYL (404 patients)
MULTI-VITAMIN (402 patients)
HUMALOG (402 patients)
Most common side effects for patients taking SORAFENIB (RAF KINASE INHIBITOR):
DIARRHOEA (613 patients)
HEPATIC FAILURE (378 patients)
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (342 patients)
HEPATIC ENCEPHALOPATHY (320 patients)
FATIGUE (300 patients)
RASH (276 patients)
ASCITES (253 patients)
ABDOMINAL PAIN (237 patients)
DECREASED APPETITE (226 patients)
UPPER GASTROINTESTINAL HAEMORRHAGE (198 patients)
PYREXIA (191 patients)
ASPARTATE AMINOTRANSFERASE INCREASED (179 patients)
NAUSEA (165 patients)
HYPERTENSION (160 patients)
ASTHENIA (154 patients)
DEHYDRATION (140 patients)
HEPATIC FUNCTION ABNORMAL (133 patients)
DYSPNOEA (131 patients)
CONFUSIONAL STATE (131 patients)
HYPOKALAEMIA (125 patients)
ALOPECIA (124 patients)
VOMITING (118 patients)
CONSTIPATION (115 patients)
INTERSTITIAL LUNG DISEASE (114 patients)
LEFT VENTRICULAR DYSFUNCTION (113 patients)
DEATH (113 patients)
ENDOCARDITIS (112 patients)
ARTHRALGIA (111 patients)
STOMATITIS (111 patients)
ABDOMINAL PAIN UPPER (110 patients)
JAUNDICE (108 patients)
HEPATIC NEOPLASM MALIGNANT (106 patients)
GASTROINTESTINAL HAEMORRHAGE (106 patients)
RETINAL VASCULAR THROMBOSIS (103 patients)
LOWER GASTROINTESTINAL HAEMORRHAGE (103 patients)
LIVER CARCINOMA RUPTURED (101 patients)
OEDEMA PERIPHERAL (97 patients)
PLEURAL EFFUSION (97 patients)
STAPHYLOCOCCAL INFECTION (96 patients)
PNEUMONIA BACTERIAL (96 patients)
ENTEROBACTER INFECTION (96 patients)
MYOPATHY (95 patients)
DRY MOUTH (94 patients)
PAIN IN EXTREMITY (93 patients)
ANXIETY (90 patients)
MALAISE (89 patients)
PULMONARY EMBOLISM (85 patients)
ANAEMIA (84 patients)
PLATELET COUNT DECREASED (81 patients)
BACK PAIN (79 patients)
SEPSIS (78 patients)
PRURITUS (78 patients)
DUODENAL ULCER (77 patients)
MIGRAINE (76 patients)
MITRAL VALVE INCOMPETENCE (76 patients)
HYPOGLYCAEMIA (76 patients)
C-REACTIVE PROTEIN INCREASED (74 patients)
BLOOD PRESSURE INCREASED (73 patients)
VARICES OESOPHAGEAL (73 patients)
HEADACHE (72 patients)
RETINAL VEIN OCCLUSION (72 patients)
ABASIA (69 patients)
RENAL FAILURE ACUTE (69 patients)
WEIGHT DECREASED (67 patients)
DEEP VEIN THROMBOSIS (67 patients)
DIZZINESS (65 patients)
ERYTHEMA (65 patients)
GENERAL PHYSICAL HEALTH DETERIORATION (64 patients)
CONVULSION (63 patients)
ALANINE AMINOTRANSFERASE INCREASED (62 patients)
DYSPHONIA (62 patients)
CEREBRAL HAEMORRHAGE (60 patients)
APHAGIA (58 patients)
COLITIS (58 patients)
PNEUMONIA (57 patients)
GASTRIC ULCER (56 patients)
HYPONATRAEMIA (55 patients)
HAEMOGLOBIN DECREASED (53 patients)
RESPIRATORY FAILURE (52 patients)
LUNG DISORDER (52 patients)
CEREBRAL ISCHAEMIA (49 patients)
PARAESTHESIA (49 patients)
BLOOD BILIRUBIN INCREASED (48 patients)
GAIT DISTURBANCE (48 patients)
THYROID CANCER METASTATIC (44 patients)
DEPRESSED LEVEL OF CONSCIOUSNESS (43 patients)
PERICARDIAL EFFUSION (41 patients)
THROMBOCYTOPENIA (41 patients)
BLISTER (41 patients)
FEBRILE NEUTROPENIA (40 patients)
BLOOD LACTATE DEHYDROGENASE INCREASED (40 patients)
HALLUCINATION (40 patients)
CHILLS (40 patients)
AMMONIA INCREASED (39 patients)
SKIN ULCER (39 patients)
BLOOD ALKALINE PHOSPHATASE INCREASED (38 patients)
PAIN (38 patients)
HYPOALBUMINAEMIA (38 patients)
HYPOCALCAEMIA (37 patients)
FALL (37 patients)
POLLAKIURIA (37 patients)
BLOOD PRESSURE DECREASED (37 patients)
SKIN EXFOLIATION (37 patients)
INSOMNIA (36 patients)
CARDIAC ARREST (36 patients)
HYPOAESTHESIA (35 patients)
INFECTIOUS PERITONITIS (35 patients)
MYOCARDIAL INFARCTION (35 patients)
RETINAL VASCULAR DISORDER (34 patients)
RENAL FAILURE (34 patients)
LIPASE INCREASED (34 patients)
HYPERKALAEMIA (33 patients)
HYPERGLYCAEMIA (33 patients)
HAEMOPTYSIS (31 patients)
ATRIAL FIBRILLATION (30 patients)
GENERALISED OEDEMA (30 patients)
FAECAL INCONTINENCE (30 patients)
WHITE BLOOD CELL COUNT DECREASED (30 patients)
CELLULITIS (29 patients)
CHEST PAIN (29 patients)
SOMNOLENCE (29 patients)
HYPERBILIRUBINAEMIA (28 patients)
HYPOTENSION (28 patients)
MUSCLE SPASMS (28 patients)
ABDOMINAL DISTENSION (27 patients)
WHITE BLOOD CELL COUNT INCREASED (27 patients)
VISION BLURRED (27 patients)
HEPATIC PAIN (26 patients)
BLOOD ALBUMIN DECREASED (26 patients)
DYSURIA (25 patients)
RASH GENERALISED (25 patients)
BLOOD SODIUM DECREASED (25 patients)
BLOOD URIC ACID INCREASED (25 patients)
COMA (25 patients)
COUGH (25 patients)
PANCYTOPENIA (25 patients)
ACUTE ABDOMEN (24 patients)
EOSINOPHIL COUNT INCREASED (24 patients)
CEREBROVASCULAR ACCIDENT (24 patients)
METASTASES TO CENTRAL NERVOUS SYSTEM (23 patients)
CEREBRAL INFARCTION (23 patients)
HYPOMAGNESAEMIA (23 patients)
RETINAL VEIN THROMBOSIS (23 patients)
GAMMA-GLUTAMYLTRANSFERASE INCREASED (23 patients)
TUMOUR LYSIS SYNDROME (22 patients)
HYPOPHOSPHATAEMIA (22 patients)
INFECTION (22 patients)
ORAL PAIN (22 patients)
BLOOD CREATININE INCREASED (22 patients)
NEUTROPENIA (22 patients)
RENAL IMPAIRMENT (22 patients)
LETHARGY (22 patients)
SKIN TOXICITY (21 patients)
TONGUE BLISTERING (21 patients)
LIVER ABSCESS (21 patients)
HAEMATEMESIS (21 patients)
OESOPHAGEAL VARICES HAEMORRHAGE (20 patients)
MENTAL IMPAIRMENT (20 patients)
NERVOUSNESS (20 patients)
NEPHROTIC SYNDROME (20 patients)
HYPOPHAGIA (20 patients)
ADRENAL INSUFFICIENCY (19 patients)
DRY SKIN (19 patients)
BLOOD AMYLASE INCREASED (19 patients)
OEDEMA (19 patients)
INFECTIOUS PLEURAL EFFUSION (19 patients)
DYSPEPSIA (19 patients)
COMA HEPATIC (19 patients)
HEART RATE INCREASED (18 patients)
HYPERTENSIVE CRISIS (18 patients)
MYALGIA (18 patients)
ECZEMA (18 patients)
URINARY TRACT INFECTION (18 patients)
NEUROMYOPATHY (18 patients)
MEDICAL DEVICE COMPLICATION (18 patients)
DIVERTICULITIS (18 patients)
OSTEOMYELITIS (18 patients)
CEREBRAL ATROPHY (18 patients)
CEREBRAL VENTRICLE DILATATION (18 patients)
DIABETIC FOOT INFECTION (18 patients)
NECK PAIN (18 patients)
OLIGURIA (17 patients)
GASTROINTESTINAL DISORDER (17 patients)
HAEMATOCHEZIA (17 patients)
DISSEMINATED INTRAVASCULAR COAGULATION (17 patients)
HYPOTHYROIDISM (17 patients)
TRANSAMINASES INCREASED (17 patients)
OROPHARYNGEAL PAIN (17 patients)
CHRONIC MYELOID LEUKAEMIA (17 patients)
NEOPLASM PROGRESSION (17 patients)
METASTASES TO ADRENALS (16 patients)
LYMPHOCYTE COUNT DECREASED (16 patients)
INTERNATIONAL NORMALISED RATIO INCREASED (16 patients)
MULTI-ORGAN FAILURE (16 patients)
FEAR (16 patients)
PANCREATIC CARCINOMA (16 patients)
HYPERSOMNIA (16 patients)
EPILEPSY (16 patients)
SUBARACHNOID HAEMORRHAGE (16 patients)
METASTASES TO LUNG (16 patients)
TACHYCARDIA (16 patients)
MUSCULAR WEAKNESS (16 patients)
KLEBSIELLA SEPSIS (16 patients)
MYOCARDIAL ISCHAEMIA (16 patients)
DYSGEUSIA (16 patients)
LUNG INFECTION (16 patients)
FAECES DISCOLOURED (16 patients)
PAIN OF SKIN (16 patients)
SPINAL FRACTURE (16 patients)
PANIC REACTION (16 patients)

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