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

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, 55 individuals taking SORAFENIB (RAF KINASE INHIBITOR) reported HYPONATRAEMIA 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 HYPONATRAEMIA. In doing so, we compare SORAFENIB (RAF KINASE INHIBITOR) with other drugs that cause HYPONATRAEMIA, to help you evaluate whether or not SORAFENIB (RAF KINASE INHIBITOR) causes HYPONATRAEMIA. Likewise, this page shows the most highly-reported side effects of SORAFENIB (RAF KINASE INHIBITOR), so you can see if HYPONATRAEMIA ranks among SORAFENIB (RAF KINASE INHIBITOR)'s most well-known side effects.
Summary Statistics
Reports of SORAFENIB (RAF KINASE INHIBITOR) causing HYPONATRAEMIA: 55
Reports of any side effect of SORAFENIB (RAF KINASE INHIBITOR) : 3329
Percentage of SORAFENIB (RAF KINASE INHIBITOR) patients where HYPONATRAEMIA is a reported side effect: 1.6521%

FDA reports of any drug causing HYPONATRAEMIA : 19923
Average percentage for all medicated patients where HYPONATRAEMIA is reported as a complication: 0.1249%

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 HYPONATRAEMIA:

ASPIRIN (2054 patients)
FOSAMAX (1495 patients)
LASIX (1365 patients)
OMEPRAZOLE (1088 patients)
HEPARIN SODIUM INJECTION (1017 patients)
FUROSEMIDE (893 patients)
HYDROCHLOROTHIAZIDE (864 patients)
CISPLATIN (809 patients)
LEVOTHYROXINE SODIUM (754 patients)
ZOMETA (753 patients)
LISINOPRIL (738 patients)
DEXAMETHASONE (719 patients)
ACETAMINOPHEN (688 patients)
PREDNISONE (686 patients)
NEXIUM (685 patients)
ALDACTONE (665 patients)
VIOXX (665 patients)
LORAZEPAM (643 patients)
SIMVASTATIN (632 patients)
PLAVIX (627 patients)
DIGOXIN (615 patients)
POTASSIUM CHLORIDE (589 patients)
COUMADIN (587 patients)
ATENOLOL (576 patients)
ALLOPURINOL (570 patients)
RAMIPRIL (568 patients)
SEROQUEL (555 patients)
AMLODIPINE (554 patients)
TRILEPTAL (553 patients)
ZOLOFT (538 patients)
CITALOPRAM HYDROBROMIDE (531 patients)
NORVASC (514 patients)
SPIRONOLACTONE (505 patients)
TEGRETOL (495 patients)
LIPITOR (493 patients)
FOLIC ACID (489 patients)
PROTONIX (486 patients)
PREDNISOLONE (480 patients)
RISPERDAL (476 patients)
DIOVAN (469 patients)
METHOTREXATE (455 patients)
NEURONTIN (444 patients)
SYNTHROID (441 patients)
DECADRON (438 patients)
VELCADE (436 patients)
CARBOPLATIN (429 patients)
ZOFRAN (422 patients)
LYRICA (417 patients)
ZYPREXA (411 patients)
PAXIL (409 patients)
CYMBALTA (403 patients)
ATIVAN (401 patients)
ZOCOR (400 patients)
MIRTAZAPINE (390 patients)
XANAX (385 patients)
ALBUTEROL (376 patients)
AMBIEN (375 patients)
PRILOSEC (368 patients)
WARFARIN SODIUM (365 patients)
FLUOROURACIL (364 patients)
METFORMIN HCL (359 patients)
CARBAMAZEPINE (358 patients)
REVLIMID (356 patients)
ENALAPRIL MALEATE (348 patients)
OXYCONTIN (347 patients)
AREDIA (347 patients)
DOCETAXEL (338 patients)
TRAMADOL HCL (330 patients)
LEVAQUIN (326 patients)
IBUPROFEN (323 patients)
LANSOPRAZOLE (317 patients)
LEXAPRO (317 patients)
EFFEXOR (307 patients)
ALENDRONATE SODIUM (302 patients)
VITAMIN D (301 patients)
METOPROLOL TARTRATE (291 patients)
KEPPRA (289 patients)
CYCLOPHOSPHAMIDE (285 patients)
BISOPROLOL FUMARATE (278 patients)
OXYCODONE HCL (277 patients)
ALPRAZOLAM (274 patients)
MORPHINE (274 patients)
GABAPENTIN (274 patients)
CLONAZEPAM (274 patients)
CELEBREX (270 patients)
PANTOPRAZOLE SODIUM (267 patients)
PREDNISONE TAB (267 patients)
LOVENOX (265 patients)
COMPAZINE (260 patients)
INDAPAMIDE (259 patients)
LACTULOSE (258 patients)
PROZAC (256 patients)
DEPAKENE (255 patients)
COREG (251 patients)
PANTOPRAZOLE (250 patients)
LANTUS (248 patients)
TOPROL-XL (247 patients)
CIPROFLOXACIN (245 patients)
CARVEDILOL (245 patients)
MAGNESIUM OXIDE (244 patients)
CORDARONE (242 patients)
REMICADE (242 patients)
METOCLOPRAMIDE (237 patients)
ESCITALOPRAM (236 patients)
ONDANSETRON (236 patients)
DURAGESIC-100 (232 patients)
VICODIN (230 patients)
CALCIUM (229 patients)
ALTACE (227 patients)
COZAAR (227 patients)
HYDROCORTISONE (226 patients)
HYZAAR (226 patients)
ZOLPIDEM (225 patients)
PREVACID (224 patients)
CAPECITABINE (224 patients)
PERCOCET (224 patients)
DIAZEPAM (220 patients)
SPIRIVA (219 patients)
SODIUM CHLORIDE (219 patients)
CETUXIMAB (218 patients)
MULTI-VITAMINS (217 patients)
GLUCOPHAGE (216 patients)
FAMOTIDINE (216 patients)
INSULIN (214 patients)
BACTRIM (213 patients)
VANCOMYCIN (210 patients)
NEXAVAR (210 patients)
CALCIUM CARBONATE (206 patients)
CRESTOR (205 patients)
TAXOTERE (205 patients)
FLUCONAZOLE (204 patients)
PAROXETINE HCL (204 patients)
BEVACIZUMAB (204 patients)
MULTI-VITAMIN (204 patients)
ADVAIR DISKUS 100/50 (203 patients)
FERROUS SULFATE TAB (201 patients)
AMOXICILLIN (200 patients)
DIFLUCAN (200 patients)
ZYVOX (198 patients)
ACTONEL (196 patients)
AMLODIPINE BESYLATE (195 patients)
SUTENT (194 patients)
TRAZODONE HCL (194 patients)
CELEXA (192 patients)
NITROGLYCERIN (192 patients)
ATACAND (189 patients)
COLACE (188 patients)
RANITIDINE (187 patients)
BENADRYL (186 patients)
KARDEGIC (184 patients)
REGLAN (183 patients)
PEPCID (182 patients)
DEROXAT (180 patients)
AVASTIN (180 patients)
FLUOXETINE (179 patients)
NEORAL (177 patients)
TAXOL (176 patients)
OXCARBAZEPINE (175 patients)
PACLITAXEL (175 patients)
RISPERIDONE (174 patients)
ERLOTINIB HYDROCHLORIDE (174 patients)
AMIODARONE HCL (174 patients)
TEMAZEPAM (172 patients)
DEXAMETHASONE TAB (171 patients)
METOPROLOL (170 patients)
OXALIPLATIN (170 patients)
VITAMIN B-12 (169 patients)
VINCRISTINE (167 patients)
ACYCLOVIR (166 patients)
LORTAB (165 patients)
HEPARIN SODIUM (164 patients)
ASCORBIC ACID (163 patients)
PREMARIN (163 patients)
OXAZEPAM (162 patients)
FENTANYL (162 patients)
ATORVASTATIN CALCIUM (160 patients)
METOPROLOL SUCCINATE (159 patients)
AMARYL (158 patients)
ETOPOSIDE (158 patients)
VALPROATE SODIUM (158 patients)
GLEEVEC (158 patients)
MORPHINE SULFATE (157 patients)
PREVISCAN (157 patients)
AMITRIPTYLINE HCL (156 patients)
PREDONINE (156 patients)
LASILIX (156 patients)
ZANTAC (155 patients)
PARACETAMOL (155 patients)
SUNITINIB MALATE (154 patients)
SORAFENIB (154 patients)
ZITHROMAX (154 patients)
TACROLIMUS (153 patients)
NYSTATIN (153 patients)
DOXORUBICIN HCL (153 patients)
ACETYLSALICYLIC ACID SRT (153 patients)
FORTEO (151 patients)
AUGMENTIN '125' (151 patients)
LAMICTAL (151 patients)
VITAMIN E (151 patients)
PRAVASTATIN (150 patients)
KALETRA (149 patients)
GLYBURIDE (145 patients)
REMERON (145 patients)
NAPROXEN (144 patients)
HALDOL (144 patients)
OLANZAPINE (144 patients)
RADIATION THERAPY (144 patients)
RIBAVIRIN (143 patients)
METHYLPREDNISOLONE (143 patients)
VOLTAREN (143 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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