Is MALAISE a side effect of SORAFENIB (RAF KINASE INHIBITOR) ? ( FactMed.com )

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

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, 89 individuals taking SORAFENIB (RAF KINASE INHIBITOR) reported MALAISE 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 MALAISE. In doing so, we compare SORAFENIB (RAF KINASE INHIBITOR) with other drugs that cause MALAISE, to help you evaluate whether or not SORAFENIB (RAF KINASE INHIBITOR) causes MALAISE. Likewise, this page shows the most highly-reported side effects of SORAFENIB (RAF KINASE INHIBITOR), so you can see if MALAISE ranks among SORAFENIB (RAF KINASE INHIBITOR)'s most well-known side effects.

Summary Statistics
Reports of SORAFENIB (RAF KINASE INHIBITOR) causing MALAISE: 89
Reports of any side effect of SORAFENIB (RAF KINASE INHIBITOR) : 3329
Percentage of SORAFENIB (RAF KINASE INHIBITOR) patients where MALAISE is a reported side effect: 2.6735%

FDA reports of any drug causing MALAISE : 90253
Average percentage for all medicated patients where MALAISE is reported as a complication: 0.5657%

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 MALAISE:

NEXIUM (5247 patients)
ASPIRIN (5151 patients)
SEROQUEL (4925 patients)
FORTEO (4596 patients)
CHANTIX (3776 patients)
HUMIRA (3605 patients)
TYSABRI (3242 patients)
LIPITOR (2832 patients)
LYRICA (2778 patients)
FOSAMAX (2559 patients)
REMICADE (2383 patients)
OMEPRAZOLE (2308 patients)
ENBREL (2253 patients)
LASIX (2236 patients)
SYNTHROID (2097 patients)
CRESTOR (2081 patients)
SIMVASTATIN (2069 patients)
CLOZARIL (2017 patients)
LISINOPRIL (2003 patients)
SANDOSTATIN LAR (1989 patients)
PREDNISONE (1972 patients)
METHOTREXATE (1955 patients)
XANAX (1912 patients)
BYETTA (1877 patients)
FUROSEMIDE (1874 patients)
ATENOLOL (1772 patients)
ZOMETA (1765 patients)
CYMBALTA (1716 patients)
HEPARIN SODIUM INJECTION (1699 patients)
LEVOTHYROXINE SODIUM (1697 patients)
FOLIC ACID (1667 patients)
METFORMIN HCL (1632 patients)
PLAVIX (1588 patients)
ACETAMINOPHEN (1576 patients)
PREDNISOLONE (1575 patients)
AVONEX (1573 patients)
NEURONTIN (1553 patients)
DIOVAN (1487 patients)
VITAMIN D (1443 patients)
NORVASC (1437 patients)
PRILOSEC (1426 patients)
LANTUS (1412 patients)
DIGOXIN (1380 patients)
TOPROL-XL (1368 patients)
NEXAVAR (1367 patients)
DURAGESIC-100 (1309 patients)
ZOLOFT (1295 patients)
OXYCONTIN (1294 patients)
HYDROCHLOROTHIAZIDE (1268 patients)
PAXIL (1186 patients)
ALLOPURINOL (1182 patients)
SYMBICORT (1176 patients)
COUMADIN (1165 patients)
ALBUTEROL (1158 patients)
LORAZEPAM (1128 patients)
EXJADE (1125 patients)
CELEBREX (1113 patients)
ADVAIR DISKUS 100/50 (1113 patients)
VIOXX (1093 patients)
AMBIEN (1088 patients)
SEROQUEL XR (1079 patients)
CLONAZEPAM (1071 patients)
SPIRIVA (1059 patients)
ZOCOR (1055 patients)
EFFEXOR (1052 patients)
IBUPROFEN (1050 patients)
GABAPENTIN (1046 patients)
AMLODIPINE (1031 patients)
CALCIUM (1012 patients)
LANSOPRAZOLE (1011 patients)
DIAZEPAM (1000 patients)
POTASSIUM CHLORIDE (995 patients)
WARFARIN SODIUM (975 patients)
PROTONIX (956 patients)
HUMALOG (917 patients)
PREVACID (913 patients)
ALPRAZOLAM (906 patients)
PREDNISONE TAB (869 patients)
SINGULAIR (842 patients)
GLEEVEC (840 patients)
REBIF (834 patients)
LEXAPRO (825 patients)
KLONOPIN (817 patients)
ALLI (811 patients)
RAMIPRIL (807 patients)
EFFEXOR XR (806 patients)
REVLIMID (802 patients)
DIANEAL (793 patients)
RIBAVIRIN (786 patients)
XOLAIR (784 patients)
METOPROLOL TARTRATE (781 patients)
PROZAC (776 patients)
ATIVAN (772 patients)
PREMARIN (750 patients)
TRAMADOL HCL (749 patients)
CLOZAPINE (742 patients)
LAMICTAL (741 patients)
TEGRETOL (718 patients)
PERCOCET (716 patients)
VICODIN (713 patients)
OXYCODONE HCL (708 patients)
PEG-INTRON (696 patients)
LEVAQUIN (693 patients)
INSULIN (691 patients)
REBETOL (685 patients)
ZYPREXA (677 patients)
ALDACTONE (667 patients)
CITALOPRAM HYDROBROMIDE (664 patients)
DEXAMETHASONE (655 patients)
MORPHINE (652 patients)
MULTI-VITAMINS (648 patients)
DECADRON (648 patients)
METFORMIN (647 patients)
ZANTAC (642 patients)
FLUOROURACIL (637 patients)
SPIRONOLACTONE (632 patients)
CALCIUM CARBONATE (624 patients)
COZAAR (618 patients)
MULTI-VITAMIN (588 patients)
COREG (587 patients)
FENTANYL (580 patients)
AMITRIPTYLINE HCL (572 patients)
ACTOS (566 patients)
GLUCOPHAGE (566 patients)
TRAZODONE HCL (565 patients)
VALTREX (562 patients)
ENALAPRIL MALEATE (555 patients)
FISH OIL (547 patients)
CYCLOPHOSPHAMIDE (541 patients)
RISPERDAL (537 patients)
METOPROLOL (536 patients)
ACTONEL (536 patients)
CARVEDILOL (536 patients)
VOLTAREN (534 patients)
CELEXA (534 patients)
AMOXICILLIN (534 patients)
NITROGLYCERIN (533 patients)
ZOFRAN (532 patients)
ZYRTEC (530 patients)
FENTANYL-100 (529 patients)
PRISTIQ (525 patients)
LORTAB (525 patients)
VALIUM (525 patients)
AREDIA (521 patients)
TYLENOL (CAPLET) (521 patients)
RECLAST (518 patients)
ZETIA (514 patients)
PAROXETINE HCL (513 patients)
AMARYL (507 patients)
ZOLEDRONOC ACID (505 patients)
FAMOTIDINE (504 patients)
WELLBUTRIN (503 patients)
ALL OTHER THERAPEUTIC PRODUCTS (498 patients)
VITAMIN B-12 (497 patients)
RANITIDINE (491 patients)
PEGASYS (486 patients)
AMLODIPINE BESYLATE (485 patients)
LEVOXYL (485 patients)
GLYBURIDE (471 patients)
PRAVASTATIN (466 patients)
ATACAND (466 patients)
BETASERON (466 patients)
TOPAMAX (465 patients)
MIRTAZAPINE (464 patients)
AFINITOR (463 patients)
VENTOLIN (462 patients)
PANTOPRAZOLE (460 patients)
XELODA (460 patients)
BENADRYL (459 patients)
TRACLEER (455 patients)
ALENDRONATE SODIUM (454 patients)
ATORVASTATIN CALCIUM (452 patients)
NEORAL (449 patients)
ALLEGRA (449 patients)
MIRENA (446 patients)
GLIPIZIDE (446 patients)
EXELON (444 patients)
AVANDIA (442 patients)
ASCORBIC ACID (438 patients)
NICODERM CQ (430 patients)
ALTACE (429 patients)
HYDROCODONE (426 patients)
LOXONIN (425 patients)
FLEXERIL (425 patients)
PARACETAMOL (423 patients)
CIMZIA (422 patients)
VALPROATE SODIUM (420 patients)
ACETYLSALICYLIC ACID (417 patients)
BISOPROLOL FUMARATE (415 patients)
TEMAZEPAM (414 patients)
ARIMIDEX (413 patients)
SUTENT (411 patients)
GEODON (408 patients)
COMMIT (407 patients)
DEPAKOTE (404 patients)
AVELOX (400 patients)
TYLENOL (399 patients)
SOLIRIS (398 patients)
NIASPAN (395 patients)
LOSARTAN POTASSIUM (394 patients)
FERROUS SULFATE TAB (392 patients)
CLONIDINE (392 patients)
PRADAXA (391 patients)
DIOVAN HCT (390 patients)
NIFEDIPINE (389 patients)
FLUOXETINE (389 patients)
CAPECITABINE (387 patients)
LUCENTIS (386 patients)
BACLOFEN (385 patients)
GILENYA (383 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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