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

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, 76 individuals taking SORAFENIB (RAF KINASE INHIBITOR) reported MITRAL VALVE INCOMPETENCE 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 MITRAL VALVE INCOMPETENCE. In doing so, we compare SORAFENIB (RAF KINASE INHIBITOR) with other drugs that cause MITRAL VALVE INCOMPETENCE, to help you evaluate whether or not SORAFENIB (RAF KINASE INHIBITOR) causes MITRAL VALVE INCOMPETENCE. Likewise, this page shows the most highly-reported side effects of SORAFENIB (RAF KINASE INHIBITOR), so you can see if MITRAL VALVE INCOMPETENCE ranks among SORAFENIB (RAF KINASE INHIBITOR)'s most well-known side effects.
Summary Statistics
Reports of SORAFENIB (RAF KINASE INHIBITOR) causing MITRAL VALVE INCOMPETENCE: 76
Reports of any side effect of SORAFENIB (RAF KINASE INHIBITOR) : 3329
Percentage of SORAFENIB (RAF KINASE INHIBITOR) patients where MITRAL VALVE INCOMPETENCE is a reported side effect: 2.2830%

FDA reports of any drug causing MITRAL VALVE INCOMPETENCE : 9504
Average percentage for all medicated patients where MITRAL VALVE INCOMPETENCE is reported as a complication: 0.0596%

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 MITRAL VALVE INCOMPETENCE:

VIOXX (4639 patients)
ASPIRIN (2259 patients)
FOSAMAX (1998 patients)
ZOMETA (1316 patients)
LASIX (1235 patients)
DIGOXIN (1229 patients)
COUMADIN (1055 patients)
LIPITOR (906 patients)
LISINOPRIL (824 patients)
AREDIA (776 patients)
ZOCOR (733 patients)
FUROSEMIDE (708 patients)
PREDNISONE (692 patients)
HEPARIN SODIUM INJECTION (634 patients)
PRILOSEC (628 patients)
PAXIL (625 patients)
PLAVIX (614 patients)
AMBIEN (606 patients)
COREG (594 patients)
ZOLOFT (582 patients)
LEVAQUIN (576 patients)
CELEBREX (547 patients)
SYNTHROID (547 patients)
POTASSIUM CHLORIDE (546 patients)
PROTONIX (544 patients)
NEXIUM (536 patients)
NEURONTIN (529 patients)
XANAX (507 patients)
TOPROL-XL (503 patients)
HYDROCHLOROTHIAZIDE (487 patients)
FOLIC ACID (482 patients)
PREVACID (479 patients)
ALBUTEROL (458 patients)
NITROGLYCERIN (449 patients)
PREMARIN (441 patients)
AVANDIA (437 patients)
NORVASC (432 patients)
SIMVASTATIN (428 patients)
ATIVAN (409 patients)
WARFARIN SODIUM (408 patients)
PERCOCET (396 patients)
ATENOLOL (390 patients)
VICODIN (361 patients)
OMEPRAZOLE (351 patients)
ACETAMINOPHEN (349 patients)
LOPRESSOR (344 patients)
ACCUTANE (341 patients)
INSULIN (336 patients)
ALLOPURINOL (326 patients)
OXYCONTIN (321 patients)
SPIRONOLACTONE (315 patients)
ZOFRAN (310 patients)
CALCIUM (303 patients)
MULTI-VITAMINS (301 patients)
LORTAB (301 patients)
IBUPROFEN (296 patients)
ZANTAC (294 patients)
ADVAIR DISKUS 100/50 (289 patients)
ZYRTEC (283 patients)
AMOXICILLIN (282 patients)
METOPROLOL TARTRATE (281 patients)
METHOTREXATE (278 patients)
DIOVAN (277 patients)
LEXAPRO (273 patients)
HERCEPTIN (268 patients)
PROZAC (264 patients)
CARDIZEM (263 patients)
FEMARA (263 patients)
EFFEXOR (262 patients)
LOVENOX (259 patients)
ALTACE (257 patients)
DEXAMETHASONE (257 patients)
LORAZEPAM (256 patients)
TYLENOL (CAPLET) (251 patients)
GABAPENTIN (250 patients)
COZAAR (249 patients)
METOPROLOL (249 patients)
GLUCOPHAGE (243 patients)
ALDACTONE (242 patients)
ASCORBIC ACID (241 patients)
VITAMIN D (239 patients)
PREDNISONE TAB (239 patients)
LEVOTHYROXINE SODIUM (237 patients)
VITAMIN E (233 patients)
ALPRAZOLAM (232 patients)
CARVEDILOL (232 patients)
FLOMAX (226 patients)
GLIPIZIDE (224 patients)
SINGULAIR (223 patients)
DECADRON (222 patients)
PEPCID (221 patients)
CELEXA (220 patients)
TAMOXIFEN CITRATE (218 patients)
ZITHROMAX (217 patients)
OXYCODONE HCL (216 patients)
TYLENOL (214 patients)
NUVARING (214 patients)
KLOR-CON (213 patients)
LYRICA (208 patients)
VITAMIN TAB (207 patients)
CALCIUM CARBONATE (205 patients)
MULTI-VITAMIN (204 patients)
MORPHINE (203 patients)
AMIODARONE HCL (201 patients)
TAXOTERE (201 patients)
ZESTRIL (201 patients)
METFORMIN HCL (201 patients)
THALIDOMIDE (200 patients)
ELAVIL (197 patients)
[THERAPY UNSPECIFIED] (197 patients)
COLACE (193 patients)
ALLEGRA (193 patients)
HYDROCODONE BITARTRATE (192 patients)
LANTUS (191 patients)
FLEXERIL (190 patients)
CRESTOR (188 patients)
REVLIMID (187 patients)
HEPARIN (184 patients)
ARANESP (181 patients)
CEPHALEXIN (181 patients)
FLONASE (180 patients)
KEFLEX (180 patients)
ATROVENT (179 patients)
PRAVACHOL (179 patients)
ARIMIDEX (178 patients)
CLARITIN (176 patients)
CLINDAMYCIN (175 patients)
RAMIPRIL (175 patients)
VITAMINS (UNSPECIFIED) (174 patients)
RADIATION THERAPY (174 patients)
WELLBUTRIN (172 patients)
CIPRO (170 patients)
ULTRAM (170 patients)
CORDARONE (169 patients)
REGLAN (168 patients)
CYMBALTA (167 patients)
FERROUS SULFATE TAB (165 patients)
FENTANYL (165 patients)
VELCADE (164 patients)
VITAMIN B-12 (163 patients)
POTASSIUM (162 patients)
ACIPHEX (162 patients)
AVONEX (161 patients)
GLYBURIDE (161 patients)
PREDNISOLONE (159 patients)
CALCIUM (UNSPECIFIED) (158 patients)
ENALAPRIL MALEATE (157 patients)
SPIRIVA (157 patients)
VANCOMYCIN (156 patients)
VALIUM (154 patients)
NASONEX (153 patients)
FOSAMAX PLUS D (153 patients)
DIAZEPAM (151 patients)
AVELOX (151 patients)
COMPAZINE (151 patients)
TRAMADOL HCL (150 patients)
CLONIDINE (150 patients)
HUMIRA (149 patients)
DILAUDID (149 patients)
DOXYCYCLINE (145 patients)
CIPROFLOXACIN (145 patients)
ALENDRONATE SODIUM (144 patients)
FASLODEX (144 patients)
FLAGYL (143 patients)
CHEMOTHERAPEUTICS NOS (143 patients)
FISH OIL (142 patients)
HYDROCODONE (142 patients)
IMDUR (142 patients)
ZETIA (141 patients)
ACTOS (141 patients)
CABERGOLINE (140 patients)
VERAPAMIL (138 patients)
CYTOXAN (138 patients)
DARVOCET-N 100 (138 patients)
LANOXIN (137 patients)
AZITHROMYCIN (137 patients)
DYAZIDE (135 patients)
BENADRYL (134 patients)
COMBIVENT (133 patients)
ACYCLOVIR (133 patients)
PREMPRO (131 patients)
TRAZODONE HCL (131 patients)
RESTORIL (130 patients)
REMICADE (130 patients)
PROMETHAZINE (130 patients)
PERIDEX (130 patients)
NAPROSYN (130 patients)
ZYPREXA (129 patients)
NYSTATIN (128 patients)
MONOPRIL (128 patients)
PRINIVIL (127 patients)
GLUCOSAMINE (127 patients)
FLUCONAZOLE (127 patients)
TEMAZEPAM (126 patients)
VIAGRA (125 patients)
AUGMENTIN '125' (124 patients)
CHLORHEXIDINE GLUCONATE (124 patients)
SKELAXIN (123 patients)
RANITIDINE (122 patients)
CLONAZEPAM (122 patients)
AMLODIPINE (122 patients)
LOVASTATIN (122 patients)
METRONIDAZOLE (121 patients)
VASOTEC (121 patients)
LUPRON (120 patients)
NAPROXEN (119 patients)
LEVOXYL (119 patients)
SINEMET (118 patients)
HYDRALAZINE HCL (117 patients)
ACCUPRIL (116 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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