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

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, 2 individuals taking SORAFENIB (RAF KINASE INHIBITOR) reported HYPERSENSITIVITY 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 HYPERSENSITIVITY. In doing so, we compare SORAFENIB (RAF KINASE INHIBITOR) with other drugs that cause HYPERSENSITIVITY, to help you evaluate whether or not SORAFENIB (RAF KINASE INHIBITOR) causes HYPERSENSITIVITY. Likewise, this page shows the most highly-reported side effects of SORAFENIB (RAF KINASE INHIBITOR), so you can see if HYPERSENSITIVITY ranks among SORAFENIB (RAF KINASE INHIBITOR)'s most well-known side effects.
Summary Statistics
Reports of SORAFENIB (RAF KINASE INHIBITOR) causing HYPERSENSITIVITY: 2
Reports of any side effect of SORAFENIB (RAF KINASE INHIBITOR) : 3329
Percentage of SORAFENIB (RAF KINASE INHIBITOR) patients where HYPERSENSITIVITY is a reported side effect: 0.0601%

FDA reports of any drug causing HYPERSENSITIVITY : 38869
Average percentage for all medicated patients where HYPERSENSITIVITY is reported as a complication: 0.2436%

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 HYPERSENSITIVITY:

FOSAMAX (2522 patients)
TYSABRI (2096 patients)
ASPIRIN (1762 patients)
HEPARIN SODIUM INJECTION (1590 patients)
REMICADE (1580 patients)
VIOXX (1330 patients)
ENBREL (1212 patients)
AVELOX (1109 patients)
LIPITOR (1105 patients)
HUMIRA (1060 patients)
SYNTHROID (953 patients)
LYRICA (935 patients)
CHANTIX (905 patients)
LISINOPRIL (861 patients)
AVONEX (851 patients)
PREDNISONE (841 patients)
BENADRYL (838 patients)
FORTEO (793 patients)
METHOTREXATE (791 patients)
NEXIUM (784 patients)
XOLAIR (752 patients)
OMEPRAZOLE (732 patients)
CELEBREX (725 patients)
ALBUTEROL (679 patients)
LASIX (633 patients)
SIMVASTATIN (627 patients)
ALEVE (624 patients)
ATENOLOL (611 patients)
ADVAIR DISKUS 100/50 (597 patients)
ACETAMINOPHEN (592 patients)
SINGULAIR (588 patients)
LEVOTHYROXINE SODIUM (572 patients)
NEURONTIN (571 patients)
FOLIC ACID (570 patients)
PLAVIX (569 patients)
IBUPROFEN (567 patients)
HYDROCHLOROTHIAZIDE (537 patients)
ZOLOFT (530 patients)
XANAX (525 patients)
NORVASC (504 patients)
SPIRIVA (489 patients)
PRILOSEC (477 patients)
ALEVE (CAPLET) (475 patients)
PREMARIN (469 patients)
TOPROL-XL (466 patients)
SEROQUEL (462 patients)
CYMBALTA (454 patients)
ZYRTEC (448 patients)
ZOCOR (417 patients)
DIOVAN (414 patients)
LEXAPRO (413 patients)
FUROSEMIDE (412 patients)
VITAMIN D (403 patients)
COUMADIN (402 patients)
CRESTOR (399 patients)
LEVAQUIN (398 patients)
PREDNISOLONE (397 patients)
LAMICTAL (394 patients)
METFORMIN HCL (390 patients)
NICODERM CQ (385 patients)
CARBOPLATIN (379 patients)
DEXAMETHASONE (361 patients)
PREVACID (355 patients)
ALLEGRA (349 patients)
ZANTAC (345 patients)
CALCIUM (343 patients)
LANTUS (342 patients)
GABAPENTIN (336 patients)
PROTONIX (333 patients)
AMOXICILLIN (332 patients)
DURAGESIC-100 (327 patients)
AMBIEN (324 patients)
PREDNISONE TAB (321 patients)
POTASSIUM CHLORIDE (319 patients)
ALLOPURINOL (316 patients)
VICODIN (307 patients)
MULTIHANCE (302 patients)
MULTI-VITAMINS (302 patients)
BYETTA (293 patients)
WELLBUTRIN (287 patients)
FLUOROURACIL (285 patients)
CLONAZEPAM (285 patients)
ZOFRAN (285 patients)
ATIVAN (284 patients)
WARFARIN SODIUM (280 patients)
SYMBICORT (276 patients)
LEVOXYL (275 patients)
RITUXIMAB (275 patients)
SOLU-MEDROL (275 patients)
KLONOPIN (272 patients)
AMLODIPINE (270 patients)
ERBITUX (270 patients)
TEGRETOL (269 patients)
ALENDRONATE SODIUM (268 patients)
LORAZEPAM (268 patients)
CLARITIN (264 patients)
EFFEXOR (257 patients)
DECADRON (255 patients)
PERCOCET (253 patients)
FOSAMAX PLUS D (253 patients)
XALATAN (252 patients)
ZETIA (252 patients)
PAXIL (252 patients)
FLONASE (251 patients)
VENTOLIN (251 patients)
ALPRAZOLAM (247 patients)
BEXTRA (247 patients)
TYLENOL (CAPLET) (246 patients)
ZITHROMAX (245 patients)
DOCETAXEL (243 patients)
METOPROLOL TARTRATE (242 patients)
ALL OTHER THERAPEUTIC PRODUCTS (239 patients)
TRAMADOL HCL (239 patients)
REBIF (239 patients)
BONIVA (238 patients)
TAXOL (236 patients)
OXYCONTIN (233 patients)
CYCLOPHOSPHAMIDE (232 patients)
PROZAC (230 patients)
PACLITAXEL (230 patients)
NIASPAN (229 patients)
RANITIDINE (224 patients)
HUMALOG (218 patients)
INSULIN (218 patients)
ACTONEL (217 patients)
PARACETAMOL (214 patients)
ELOXATIN (213 patients)
ACCUTANE (213 patients)
NITROGLYCERIN (210 patients)
REVLIMID (208 patients)
COZAAR (207 patients)
GAMMAGARD LIQUID (207 patients)
ASCORBIC ACID (207 patients)
MORPHINE (206 patients)
VITAMIN E (205 patients)
NASONEX (205 patients)
ZYPREXA (203 patients)
AZITHROMYCIN (202 patients)
TYLENOL (202 patients)
ENALAPRIL MALEATE (199 patients)
VANCOMYCIN (198 patients)
DIAZEPAM (196 patients)
AUGMENTIN '125' (195 patients)
BACTRIM (195 patients)
MULTI-VITAMIN (194 patients)
FLEXERIL (194 patients)
COPAXONE (194 patients)
HEPARIN SODIUM (193 patients)
OXALIPLATIN (192 patients)
FISH OIL (191 patients)
COREG (190 patients)
ZOMETA (188 patients)
GLUCOPHAGE (187 patients)
ADVIL (184 patients)
METFORMIN (183 patients)
GLIPIZIDE (183 patients)
MOTRIN (182 patients)
LANSOPRAZOLE (181 patients)
FLOVENT (181 patients)
DILANTIN (180 patients)
CIPROFLOXACIN (180 patients)
TRAZODONE HCL (179 patients)
OXYCODONE HCL (179 patients)
RAMIPRIL (178 patients)
VOLTAREN (177 patients)
HEPARIN (176 patients)
TOPAMAX (176 patients)
NOVOLOG (175 patients)
CELEXA (174 patients)
FENTANYL (173 patients)
NEULASTA (173 patients)
HYDROCORTISONE (170 patients)
DIGOXIN (169 patients)
COMBIVENT (169 patients)
GEODON (166 patients)
DEPAKOTE (166 patients)
CALCIUM (UNSPECIFIED) (165 patients)
EPOGEN (165 patients)
LORTAB (164 patients)
NAPROXEN (164 patients)
ARANESP (163 patients)
MABTHERA (163 patients)
VITAMIN B-12 (162 patients)
OMALIZUMAB (161 patients)
FENTANYL-100 (161 patients)
METOPROLOL SUCCINATE (161 patients)
AVASTIN (160 patients)
METOPROLOL (159 patients)
LOVENOX (159 patients)
ATORVASTATIN CALCIUM (158 patients)
TAXOTERE (157 patients)
PEPCID (157 patients)
LEUCOVORIN CALCIUM (156 patients)
PLAQUENIL (155 patients)
VALIUM (155 patients)
PULMICORT (155 patients)
ACYCLOVIR (153 patients)
GLEEVEC (152 patients)
VALTREX (151 patients)
MIRENA (150 patients)
AMITRIPTYLINE HCL (150 patients)
LOPRESSOR (150 patients)
ACETYLSALICYLIC ACID SRT (149 patients)
CLONIDINE (149 patients)
FAMOTIDINE (149 patients)
ACTOS (148 patients)
DIOVAN HCT (148 patients)
[THERAPY UNSPECIFIED] (146 patients)
ALTACE (146 patients)
GLYBURIDE (145 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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