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

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, 276 individuals taking SORAFENIB (RAF KINASE INHIBITOR) reported RASH 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 RASH. In doing so, we compare SORAFENIB (RAF KINASE INHIBITOR) with other drugs that cause RASH, to help you evaluate whether or not SORAFENIB (RAF KINASE INHIBITOR) causes RASH. Likewise, this page shows the most highly-reported side effects of SORAFENIB (RAF KINASE INHIBITOR), so you can see if RASH ranks among SORAFENIB (RAF KINASE INHIBITOR)'s most well-known side effects.
Summary Statistics
Reports of SORAFENIB (RAF KINASE INHIBITOR) causing RASH: 276
Reports of any side effect of SORAFENIB (RAF KINASE INHIBITOR) : 3329
Percentage of SORAFENIB (RAF KINASE INHIBITOR) patients where RASH is a reported side effect: 8.2908%

FDA reports of any drug causing RASH : 80690
Average percentage for all medicated patients where RASH is reported as a complication: 0.5057%

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 RASH:

HUMIRA (4676 patients)
ASPIRIN (4350 patients)
LAMICTAL (4338 patients)
FOSAMAX (3376 patients)
REMICADE (2807 patients)
NEXAVAR (2758 patients)
LIPITOR (2299 patients)
PREDNISONE (2294 patients)
ENBREL (2243 patients)
METHOTREXATE (2100 patients)
SYNTHROID (1997 patients)
VIOXX (1985 patients)
LISINOPRIL (1913 patients)
LASIX (1833 patients)
REVLIMID (1817 patients)
NEXIUM (1731 patients)
CHANTIX (1658 patients)
FOLIC ACID (1645 patients)
PREDNISOLONE (1632 patients)
LYRICA (1592 patients)
RIBAVIRIN (1590 patients)
GLEEVEC (1490 patients)
OMEPRAZOLE (1467 patients)
ACCUTANE (1459 patients)
CELEBREX (1446 patients)
ACETAMINOPHEN (1438 patients)
PEGASYS (1428 patients)
HEPARIN SODIUM INJECTION (1400 patients)
SEROQUEL (1388 patients)
SIMVASTATIN (1368 patients)
NIASPAN (1358 patients)
ATENOLOL (1352 patients)
COUMADIN (1310 patients)
LEVOTHYROXINE SODIUM (1296 patients)
NORVASC (1267 patients)
XANAX (1248 patients)
TYSABRI (1243 patients)
NEURONTIN (1236 patients)
PLAVIX (1233 patients)
AVELOX (1208 patients)
ZOMETA (1208 patients)
HYDROCHLOROTHIAZIDE (1172 patients)
ALLOPURINOL (1172 patients)
BENADRYL (1167 patients)
CYMBALTA (1071 patients)
ZOLOFT (1069 patients)
DEXAMETHASONE (1066 patients)
AMBIEN (1065 patients)
LEXAPRO (1061 patients)
FUROSEMIDE (1045 patients)
IBUPROFEN (1039 patients)
LEVAQUIN (1038 patients)
TEGRETOL (1022 patients)
VITAMIN D (984 patients)
DIOVAN (975 patients)
ALBUTEROL (972 patients)
EXJADE (952 patients)
FORTEO (952 patients)
PRILOSEC (951 patients)
CRESTOR (938 patients)
ZOCOR (920 patients)
PREDNISONE TAB (918 patients)
ERBITUX (917 patients)
CALCIUM (912 patients)
OXYCONTIN (905 patients)
PAXIL (901 patients)
PROTONIX (890 patients)
TARCEVA (885 patients)
TOPROL-XL (877 patients)
PREVACID (865 patients)
ADVAIR DISKUS 100/50 (864 patients)
ZYRTEC (850 patients)
METFORMIN HCL (842 patients)
ATIVAN (840 patients)
LORAZEPAM (832 patients)
MAGNEVIST (810 patients)
GABAPENTIN (802 patients)
REBETOL (802 patients)
VICODIN (792 patients)
SPIRIVA (788 patients)
SINGULAIR (773 patients)
DECADRON (765 patients)
POTASSIUM CHLORIDE (762 patients)
AMLODIPINE (761 patients)
AMOXICILLIN (759 patients)
WARFARIN SODIUM (758 patients)
AREDIA (755 patients)
LANSOPRAZOLE (753 patients)
WELLBUTRIN (724 patients)
ALLEGRA (710 patients)
KLONOPIN (705 patients)
CLONAZEPAM (699 patients)
PEG-INTRON (689 patients)
PREMARIN (688 patients)
INCIVEK (679 patients)
PERCOCET (669 patients)
BEXTRA (662 patients)
VANCOMYCIN (661 patients)
ZOFRAN (659 patients)
METOPROLOL TARTRATE (658 patients)
MULTI-VITAMINS (656 patients)
EFFEXOR (648 patients)
DIGOXIN (642 patients)
LAMOTRIGINE (638 patients)
ALPRAZOLAM (635 patients)
ZANTAC (628 patients)
MULTI-VITAMIN (627 patients)
AVONEX (621 patients)
IRESSA (620 patients)
COPEGUS (616 patients)
BACTRIM (606 patients)
ERLOTINIB HYDROCHLORIDE (602 patients)
LANTUS (599 patients)
FISH OIL (596 patients)
OXYCODONE HCL (595 patients)
PROZAC (594 patients)
ACYCLOVIR (589 patients)
FLUOROURACIL (588 patients)
JANUVIA (585 patients)
ZITHROMAX (572 patients)
CYCLOPHOSPHAMIDE (570 patients)
AUGMENTIN '125' (563 patients)
CARBOPLATIN (547 patients)
TYKERB (543 patients)
XELODA (540 patients)
TRAZODONE HCL (535 patients)
VITAMIN B-12 (534 patients)
DURAGESIC-100 (532 patients)
CIPROFLOXACIN (532 patients)
ASCORBIC ACID (524 patients)
TRAMADOL HCL (522 patients)
DEPAKOTE (520 patients)
COREG (519 patients)
TASIGNA (517 patients)
MORPHINE (515 patients)
ZETIA (514 patients)
VALTREX (510 patients)
INSULIN (507 patients)
VOLTAREN (506 patients)
NO CONCURRENT MEDICATION (505 patients)
CELEXA (504 patients)
EPOGEN (503 patients)
CIMZIA (499 patients)
KEPPRA (497 patients)
FAMOTIDINE (490 patients)
TYLENOL (CAPLET) (482 patients)
WELLBUTRIN XL (480 patients)
METOPROLOL (479 patients)
TELAVIC (TELAPREVIR) (478 patients)
PROCRIT (471 patients)
FACTIVE (471 patients)
RISPERDAL (469 patients)
CLARITIN (465 patients)
VALIUM (465 patients)
RANITIDINE (458 patients)
ACTONEL (457 patients)
TOPAMAX (455 patients)
DIFLUCAN (452 patients)
TYLENOL (452 patients)
VELCADE (449 patients)
LORTAB (437 patients)
DIAZEPAM (437 patients)
LOXONIN (436 patients)
FLOMAX (434 patients)
OMNISCAN (433 patients)
PREDONINE (432 patients)
ALENDRONATE SODIUM (432 patients)
FLUCONAZOLE (431 patients)
CYCLOSPORINE (425 patients)
LOVENOX (424 patients)
NAPROXEN (419 patients)
VITAMIN E (414 patients)
ABILIFY (413 patients)
SPIRONOLACTONE (409 patients)
FLEXERIL (409 patients)
LEVOXYL (394 patients)
DEPAKENE (394 patients)
PANTOPRAZOLE (392 patients)
DOCETAXEL (391 patients)
FLONASE (390 patients)
BYETTA (389 patients)
NEUPOGEN (388 patients)
CALCIUM CARBONATE (387 patients)
ALDACTONE (387 patients)
BONIVA (384 patients)
CISPLATIN (383 patients)
FENTANYL (383 patients)
GLUCOPHAGE (383 patients)
COZAAR (381 patients)
METFORMIN (380 patients)
COMPAZINE (379 patients)
ALTACE (378 patients)
PEPCID (375 patients)
ZYPREXA (373 patients)
SUTENT (372 patients)
AVASTIN (371 patients)
ACTOS (371 patients)
DILANTIN (371 patients)
TRUVADA (369 patients)
CLONIDINE (366 patients)
COLACE (363 patients)
XOLAIR (363 patients)
CLARITHROMYCIN (363 patients)
MIRENA (359 patients)
SIMCOR (358 patients)
GLIPIZIDE (356 patients)
ARANESP (353 patients)
ENALAPRIL MALEATE (351 patients)
RAMIPRIL (350 patients)
SANDOSTATIN LAR (349 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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