Is CHOLESTASIS 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 CHOLESTASIS.

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

Summary Statistics
Reports of SORAFENIB (RAF KINASE INHIBITOR) causing CHOLESTASIS: 1
Reports of any side effect of SORAFENIB (RAF KINASE INHIBITOR) : 3329
Percentage of SORAFENIB (RAF KINASE INHIBITOR) patients where CHOLESTASIS is a reported side effect: 0.0300%

FDA reports of any drug causing CHOLESTASIS : 6251
Average percentage for all medicated patients where CHOLESTASIS is reported as a complication: 0.0392%

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 CHOLESTASIS:

ACETAMINOPHEN (422 patients)
PREDNISOLONE (347 patients)
OMEPRAZOLE (332 patients)
ASPIRIN (329 patients)
NEXIUM (282 patients)
LASIX (255 patients)
CYCLOSPORINE (238 patients)
METHOTREXATE (202 patients)
AUGMENTIN '125' (195 patients)
ALLOPURINOL (190 patients)
PREDNISONE (189 patients)
TACROLIMUS (186 patients)
MYCOPHENOLATE MOFETIL (180 patients)
BACTRIM (176 patients)
LEVOTHYROXINE SODIUM (174 patients)
PLAVIX (155 patients)
FUROSEMIDE (148 patients)
CYCLOPHOSPHAMIDE (141 patients)
CORDARONE (140 patients)
RAMIPRIL (133 patients)
VANCOMYCIN (126 patients)
CORTANCYL (125 patients)
KEPPRA (119 patients)
VFEND (118 patients)
PARACETAMOL (117 patients)
XANAX (116 patients)
IBUPROFEN (115 patients)
LOVENOX (115 patients)
ATENOLOL (114 patients)
NEORAL (114 patients)
ROCEPHIN (113 patients)
ATARAX (111 patients)
LAMIVUDINE (110 patients)
TAHOR (109 patients)
KARDEGIC (109 patients)
FLAGYL (108 patients)
AMOXICILLIN (108 patients)
METHYLPREDNISOLONE (105 patients)
ATORVASTATIN CALCIUM (103 patients)
CRESTOR (102 patients)
PROGRAF (101 patients)
TRUVADA (101 patients)
NORVIR (100 patients)
LYRICA (99 patients)
NEURONTIN (98 patients)
TRAMADOL HCL (95 patients)
PREVISCAN (94 patients)
PREDNISONE TAB (94 patients)
METFORMIN HCL (94 patients)
MOPRAL (93 patients)
CIPROFLOXACIN (90 patients)
FLUCONAZOLE (90 patients)
REMICADE (89 patients)
PANTOPRAZOLE SODIUM (89 patients)
FOLIC ACID (87 patients)
INSULIN (87 patients)
TAZOCILLINE (87 patients)
ACYCLOVIR (86 patients)
LANSOPRAZOLE (85 patients)
AMLODIPINE (85 patients)
SANDIMMUNE (85 patients)
LAMICTAL (85 patients)
DEPAKENE (84 patients)
POTASSIUM CHLORIDE (84 patients)
TRACLEER (84 patients)
KALETRA (83 patients)
SIMVASTATIN (80 patients)
CYTARABINE (79 patients)
DEXAMETHASONE (79 patients)
ZIDOVUDINE (78 patients)
TRIFLUCAN (78 patients)
VOLTAREN (78 patients)
MORPHINE (78 patients)
LORAZEPAM (77 patients)
CELLCEPT (77 patients)
IMOVANE (76 patients)
AZATHIOPRINE (76 patients)
HUMIRA (76 patients)
PANTOPRAZOLE (75 patients)
ALDACTONE (75 patients)
BISOPROLOL FUMARATE (74 patients)
GLUCOPHAGE (74 patients)
LIPITOR (72 patients)
ZOLOFT (72 patients)
TRILEPTAL (71 patients)
SOLU-MEDROL (70 patients)
STILNOX (70 patients)
CANCIDAS (69 patients)
NORVASC (69 patients)
CLONAZEPAM (68 patients)
DIDANOSINE (67 patients)
LEVOFLOXACIN (67 patients)
CLARITHROMYCIN (67 patients)
AUGMENTIN (66 patients)
HEPARIN SODIUM INJECTION (65 patients)
DIFFU K (65 patients)
IRBESARTAN (65 patients)
PRIMAXIN (65 patients)
DIGOXIN (64 patients)
AMBISOME (64 patients)
CIFLOX (64 patients)
OFLOCET (63 patients)
DEROXAT (62 patients)
VORICONAZOLE (62 patients)
TEGRETOL (62 patients)
GLEEVEC (62 patients)
ACTONEL (61 patients)
SUSTIVA (61 patients)
LAMISIL (59 patients)
INIPOMP (59 patients)
TORSEMIDE (58 patients)
TAVANIC (57 patients)
PROZAC (56 patients)
HYDROCHLOROTHIAZIDE (56 patients)
LASILIX (56 patients)
ZOVIRAX (56 patients)
AMLOR (56 patients)
RIFADIN (55 patients)
COUMADIN (55 patients)
CALCIPARINE (55 patients)
ZYPREXA (55 patients)
EFFEXOR (55 patients)
LANTUS (54 patients)
LEXOMIL (54 patients)
CYMBALTA (54 patients)
RAPAMUNE (54 patients)
TENORMIN (53 patients)
ACUPAN (53 patients)
LEVOTHYROX (53 patients)
RITUXIMAB (52 patients)
GENTAMICIN (52 patients)
ENALAPRIL MALEATE (52 patients)
PRAVASTATIN (51 patients)
TEMODAL (51 patients)
RISPERDAL (51 patients)
DAFALGAN (50 patients)
VINCRISTINE (50 patients)
ARAVA (50 patients)
SPIRONOLACTONE (50 patients)
HEPARIN (50 patients)
AMPHOTERICIN B (49 patients)
DOLIPRANE (49 patients)
DIOVAN (48 patients)
ERYTHROMYCIN (48 patients)
ESOMEPRAZOLE MAGNESIUM (47 patients)
AMIODARONE HCL (47 patients)
ZOCOR (47 patients)
OXAZEPAM (47 patients)
TERCIAN (47 patients)
AMOXICILLIN AND CLAVULANATE POTASSIUM (47 patients)
FAMOTIDINE (46 patients)
HYDROCORTISONE (46 patients)
MYAMBUTOL (46 patients)
ZOFRAN (46 patients)
TIENAM (46 patients)
FLUDARA (46 patients)
URSODIOL (46 patients)
VIREAD (45 patients)
FUZEON (45 patients)
ETOPOSIDE (45 patients)
ALPRAZOLAM (45 patients)
EFAVIRENZ (45 patients)
REYATAZ (44 patients)
HALDOL (44 patients)
PERFALGAN (44 patients)
RIVOTRIL (43 patients)
ATORVASTATIN (43 patients)
LACTULOSE (43 patients)
LISINOPRIL (43 patients)
ZOLPIDEM (43 patients)
METOPROLOL TARTRATE (43 patients)
SECTRAL (43 patients)
VIRAMUNE (43 patients)
TRIATEC (43 patients)
CEFTRIAXONE (43 patients)
RIFAMPICIN (42 patients)
MOTILIUM (42 patients)
RANITIDINE (42 patients)
ZOLPIDEM TARTRATE (42 patients)
EPIVIR (42 patients)
OFLOXACIN (42 patients)
ISENTRESS (42 patients)
WARFARIN SODIUM (42 patients)
FORLAX (41 patients)
MIDAZOLAM HCL (41 patients)
CITALOPRAM HYDROBROMIDE (41 patients)
FERROUS SULFATE TAB (41 patients)
SULFASALAZINE (41 patients)
PAROXETINE HCL (41 patients)
AMIKACIN (41 patients)
FLUOROURACIL (41 patients)
MIRTAZAPINE (40 patients)
ATACAND (40 patients)
IMMUCYST (40 patients)
KIVEXA (40 patients)
GEMZAR (40 patients)
PRIMPERAN TAB (40 patients)
FLUDARABINE PHOSPHATE (40 patients)
SIMULECT (40 patients)
COTRIM (39 patients)
SPASFON (39 patients)
ENBREL (39 patients)
RABEPRAZOLE SODIUM (39 patients)
NEUPOGEN (39 patients)
SUTENT (39 patients)
CERTICAN (39 patients)
RALTEGRAVIR (39 patients)
THYMOGLOBULIN (39 patients)
PIPERACILLIN AND TAZOBACTAM (38 patients)
FENOFIBRATE (38 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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