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

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, 3 individuals taking SORAFENIB (RAF KINASE INHIBITOR) reported UNEVALUABLE EVENT 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 UNEVALUABLE EVENT. In doing so, we compare SORAFENIB (RAF KINASE INHIBITOR) with other drugs that cause UNEVALUABLE EVENT, to help you evaluate whether or not SORAFENIB (RAF KINASE INHIBITOR) causes UNEVALUABLE EVENT. Likewise, this page shows the most highly-reported side effects of SORAFENIB (RAF KINASE INHIBITOR), so you can see if UNEVALUABLE EVENT ranks among SORAFENIB (RAF KINASE INHIBITOR)'s most well-known side effects.
Summary Statistics
Reports of SORAFENIB (RAF KINASE INHIBITOR) causing UNEVALUABLE EVENT: 3
Reports of any side effect of SORAFENIB (RAF KINASE INHIBITOR) : 3329
Percentage of SORAFENIB (RAF KINASE INHIBITOR) patients where UNEVALUABLE EVENT is a reported side effect: 0.0901%

FDA reports of any drug causing UNEVALUABLE EVENT : 21046
Average percentage for all medicated patients where UNEVALUABLE EVENT is reported as a complication: 0.1319%

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 UNEVALUABLE EVENT:

TRASYLOL (12043 patients)
HEPARIN (2997 patients)
LASIX (2295 patients)
PROTAMINE SULFATE (1641 patients)
NITROGLYCERIN (1619 patients)
DIGOXIN (1364 patients)
RED BLOOD CELLS (1352 patients)
ACETYLSALICYLIC ACID SRT (1352 patients)
METOCLOPRAMIDE (1265 patients)
ASPIRIN (1221 patients)
LIPITOR (1175 patients)
VERSED (1156 patients)
VANCOMYCIN (1039 patients)
FENTANYL (1004 patients)
LISINOPRIL (973 patients)
PLAVIX (894 patients)
INSULIN (885 patients)
PLATELETS (882 patients)
COUMADIN (764 patients)
MANNITOL (754 patients)
EPINEPHRINE (733 patients)
HUMIRA (712 patients)
ANCEF (683 patients)
TOPROL-XL (666 patients)
DOPAMINE HCL (665 patients)
NORVASC (663 patients)
LIDOCAINE (632 patients)
ATENOLOL (611 patients)
FUROSEMIDE (588 patients)
ZOCOR (588 patients)
AMIODARONE HCL (571 patients)
FRESH FROZEN PLASMA (556 patients)
LOPRESSOR (543 patients)
COREG (537 patients)
POTASSIUM CHLORIDE (508 patients)
REGLAN (489 patients)
LETAIRIS (475 patients)
MILRINONE (473 patients)
HYDROCHLOROTHIAZIDE (463 patients)
SYNTHROID (459 patients)
CHANTIX (453 patients)
EFFEXOR XR (449 patients)
LEVOPHED (441 patients)
ALBUMIN (HUMAN) (440 patients)
PROTONIX (435 patients)
PROPOFOL (434 patients)
METOPROLOL TARTRATE (414 patients)
XANAX (408 patients)
NEURONTIN (405 patients)
LOVENOX (403 patients)
SODIUM BICARBONATE (396 patients)
PREDNISONE (386 patients)
CALCIUM CHLORIDE (375 patients)
LYRICA (372 patients)
LEVAQUIN (368 patients)
SIMVASTATIN (366 patients)
NEXIUM (336 patients)
CEFAZOLIN (332 patients)
PLASMA (324 patients)
DIOVAN (319 patients)
OXYCONTIN (308 patients)
CONTRAST MEDIA (303 patients)
PRILOSEC (300 patients)
ACETAMINOPHEN (298 patients)
ALLOPURINOL (284 patients)
ALBUTEROL (283 patients)
PHENYLEPHRINE HCL (283 patients)
CELEBREX (282 patients)
LANTUS (282 patients)
MORPHINE (281 patients)
PREVACID (279 patients)
IBUPROFEN (276 patients)
SPIRONOLACTONE (276 patients)
SOLU-MEDROL (276 patients)
FOLIC ACID (275 patients)
MAGNESIUM SULFATE (272 patients)
ZOLOFT (271 patients)
PRISTIQ (265 patients)
ALTACE (263 patients)
METHOTREXATE (263 patients)
IMDUR (260 patients)
METFORMIN HCL (258 patients)
AMICAR (257 patients)
PAVULON (255 patients)
DOBUTAMINE HCL (251 patients)
AMBIEN (246 patients)
METOPROLOL (246 patients)
COZAAR (245 patients)
DEPAKOTE (245 patients)
LEXAPRO (243 patients)
EFFEXOR (242 patients)
CARDIZEM (234 patients)
MIRENA (233 patients)
ETOMIDATE (230 patients)
WARFARIN SODIUM (229 patients)
ATIVAN (227 patients)
ZINACEF (225 patients)
OMEPRAZOLE (224 patients)
GLIPIZIDE (222 patients)
BENADRYL (220 patients)
MIDAZOLAM HCL (216 patients)
LEVOTHYROXINE SODIUM (216 patients)
HEPARIN SODIUM (215 patients)
GLUCOPHAGE (211 patients)
GLYBURIDE (210 patients)
CLONIDINE (210 patients)
GABAPENTIN (207 patients)
VICODIN (204 patients)
ZESTRIL (202 patients)
ALDACTONE (195 patients)
ZETIA (195 patients)
CRESTOR (195 patients)
ENALAPRIL MALEATE (194 patients)
LORAZEPAM (193 patients)
VASOPRESSIN (193 patients)
LANOXIN (193 patients)
AMIODARONE (192 patients)
AVANDIA (186 patients)
PRIMACOR (186 patients)
ACTOS (185 patients)
VIOXX (185 patients)
CYMBALTA (182 patients)
AVELOX (180 patients)
PROTAMINE (179 patients)
CEFUROXIME (179 patients)
PEPCID (179 patients)
BUMEX (175 patients)
OMNIPAQUE 140 (175 patients)
CARVEDILOL (174 patients)
CLOZAPINE (171 patients)
NOREPINEPHRINE BITARTRATE (171 patients)
PREDNISONE TAB (170 patients)
VECURONIUM BROMIDE (169 patients)
MIDAZOLAM (168 patients)
AVONEX (167 patients)
DURAGESIC-100 (165 patients)
PERCOCET (164 patients)
POTASSIUM (164 patients)
FENTANYL-100 (163 patients)
AMOXICILLIN (159 patients)
ACCUTANE (159 patients)
SEROQUEL (159 patients)
AMLODIPINE (159 patients)
NIPRIDE (158 patients)
VALIUM (157 patients)
REMICADE (157 patients)
CRYOPRECIPITATES (157 patients)
PAPAVERINE (156 patients)
ALPRAZOLAM (155 patients)
SINGULAIR (152 patients)
SOLIRIS (151 patients)
YAZ (150 patients)
METOPROLOL SUCCINATE (150 patients)
ORTHO EVRA (149 patients)
LORTAB (148 patients)
PAXIL (147 patients)
HYDRALAZINE HCL (147 patients)
PREMARIN (146 patients)
CLONAZEPAM (146 patients)
DILANTIN (146 patients)
ADVAIR DISKUS 100/50 (146 patients)
WELLBUTRIN (145 patients)
QUININE (MANUFACTURER UNKNOWN) (145 patients)
VYTORIN (144 patients)
PRAVACHOL (144 patients)
YASMIN (144 patients)
PROZAC (143 patients)
DILTIAZEM (142 patients)
ZAROXOLYN (142 patients)
CARDIOPLEGIA (142 patients)
ZANTAC (140 patients)
DOPAMINE (139 patients)
ENBREL (139 patients)
TRICOR (138 patients)
CIPROFLOXACIN (138 patients)
FOSAMAX (137 patients)
KLONOPIN (137 patients)
CAPTOPRIL (135 patients)
BYETTA (135 patients)
PANCURONIUM BROMIDE (135 patients)
SPIRIVA (134 patients)
INSULIN [INSULIN] (133 patients)
VASOTEC (132 patients)
NEO-SYNEPHRINOL (131 patients)
GENTAMICIN (131 patients)
TRAMADOL HCL (131 patients)
SUCCINYLCHOLINE CHLORIDE (131 patients)
NIASPAN (131 patients)
HUMALOG (130 patients)
CALCIUM (128 patients)
DIAZEPAM (128 patients)
REBIF (127 patients)
ZYRTEC (126 patients)
DOBUTAMINE HYDROCHLORIDE (125 patients)
TRAZODONE HCL (124 patients)
OXYCODONE HCL (123 patients)
ALL OTHER THERAPEUTIC PRODUCTS (123 patients)
MULTI-VITAMIN (123 patients)
ALEVE (CAPLET) (122 patients)
REVLIMID (122 patients)
RISPERDAL (122 patients)
VERAPAMIL (121 patients)
AVAPRO (118 patients)
MOTRIN (114 patients)
VIAGRA (113 patients)
DOBUTREX (113 patients)
VITAMIN D (113 patients)
CIPRO (111 patients)
KLOR-CON (111 patients)
BETASERON (111 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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