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

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, 72 individuals taking SORAFENIB (RAF KINASE INHIBITOR) reported HEADACHE 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 HEADACHE. In doing so, we compare SORAFENIB (RAF KINASE INHIBITOR) with other drugs that cause HEADACHE, to help you evaluate whether or not SORAFENIB (RAF KINASE INHIBITOR) causes HEADACHE. Likewise, this page shows the most highly-reported side effects of SORAFENIB (RAF KINASE INHIBITOR), so you can see if HEADACHE ranks among SORAFENIB (RAF KINASE INHIBITOR)'s most well-known side effects.
Summary Statistics
Reports of SORAFENIB (RAF KINASE INHIBITOR) causing HEADACHE: 72
Reports of any side effect of SORAFENIB (RAF KINASE INHIBITOR) : 3329
Percentage of SORAFENIB (RAF KINASE INHIBITOR) patients where HEADACHE is a reported side effect: 2.1628%

FDA reports of any drug causing HEADACHE : 141115
Average percentage for all medicated patients where HEADACHE is reported as a complication: 0.8844%

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 )
METASTASIS ( 3 patients )
BILIARY CANCER METASTATIC ( 3 patients )
COLON CANCER METASTATIC ( 2 patients )
HYPOPHARYNGEAL CANCER ( 2 patients )
DESMOID TUMOUR ( 2 patients )
NEUROENDOCRINE CARCINOMA ( 2 patients )
LUNG NEOPLASM MALIGNANT ( 2 patients )
ACUTE MYELOID LEUKAEMIA (IN REMISSION) ( 2 patients )
OESOPHAGEAL CARCINOMA ( 2 patients )
METASTATIC MALIGNANT MELANOMA ( 2 patients )
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED ( 2 patients )
METASTATIC SQUAMOUS CELL CARCINOMA ( 2 patients )
RENAL CELL CARCINOMA STAGE IV ( 2 patients )
ANGINA PECTORIS ( 2 patients )
OSTEOSARCOMA METASTATIC ( 2 patients )
METASTATIC OCULAR MELANOMA ( 2 patients )
BONE SARCOMA ( 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 )
LUNG ADENOCARCINOMA ( 1 patients )
RENAL CANCER METASTATIC ( 1 patients )
ACUTE MYELOID LEUKAEMIA ( 1 patients )
DIFFUSE LARGE B-CELL LYMPHOMA ( 1 patients )
NEUROENDOCRINE CARCINOMA OF THE SKIN ( 1 patients )
MALIGNANT HISTIOCYTOSIS ( 1 patients )
MALIGNANT SOFT TISSUE NEOPLASM ( 1 patients )
SARCOMA ( 1 patients )
ANTICOAGULANT THERAPY ( 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 HEADACHE:

ASPIRIN (8010 patients)
VIOXX (7647 patients)
TYSABRI (7046 patients)
ENBREL (6413 patients)
HUMIRA (6344 patients)
FOSAMAX (6320 patients)
SEROQUEL (4755 patients)
AVONEX (4430 patients)
CHANTIX (4352 patients)
LIPITOR (4317 patients)
SYNTHROID (4182 patients)
NEXIUM (4118 patients)
PREDNISONE (3832 patients)
METHOTREXATE (3717 patients)
FORTEO (3668 patients)
LISINOPRIL (3370 patients)
REMICADE (3344 patients)
LYRICA (3308 patients)
XANAX (3307 patients)
CYMBALTA (3244 patients)
NEURONTIN (3049 patients)
ACCUTANE (3042 patients)
ZOLOFT (3034 patients)
HEPARIN SODIUM INJECTION (3020 patients)
PAXIL (3012 patients)
FOLIC ACID (2700 patients)
SOLIRIS (2684 patients)
ATENOLOL (2625 patients)
OMEPRAZOLE (2564 patients)
ACETAMINOPHEN (2562 patients)
AMBIEN (2538 patients)
BYETTA (2501 patients)
PRILOSEC (2483 patients)
COUMADIN (2464 patients)
HYDROCHLOROTHIAZIDE (2423 patients)
SIMVASTATIN (2394 patients)
IBUPROFEN (2388 patients)
VITAMIN D (2333 patients)
LEVOTHYROXINE SODIUM (2313 patients)
CELEBREX (2294 patients)
LASIX (2287 patients)
ALBUTEROL (2287 patients)
CRESTOR (2259 patients)
ZOMETA (2258 patients)
LEXAPRO (2228 patients)
TOPROL-XL (2180 patients)
METFORMIN HCL (2128 patients)
PLAVIX (2072 patients)
NORVASC (2061 patients)
SANDOSTATIN LAR (2022 patients)
REBIF (1999 patients)
OXYCONTIN (1990 patients)
PROTONIX (1945 patients)
VICODIN (1924 patients)
PREVACID (1917 patients)
ZOCOR (1881 patients)
ALEVE (CAPLET) (1871 patients)
DIOVAN (1845 patients)
CLONAZEPAM (1843 patients)
ATIVAN (1837 patients)
CALCIUM (1834 patients)
EFFEXOR (1825 patients)
GABAPENTIN (1817 patients)
SINGULAIR (1793 patients)
PREMARIN (1755 patients)
FUROSEMIDE (1748 patients)
LORAZEPAM (1716 patients)
ADVAIR DISKUS 100/50 (1707 patients)
KLONOPIN (1699 patients)
PROZAC (1682 patients)
WELLBUTRIN (1653 patients)
PERCOCET (1622 patients)
NIASPAN (1607 patients)
EFFEXOR XR (1546 patients)
AREDIA (1509 patients)
TOPAMAX (1500 patients)
PREDNISONE TAB (1487 patients)
MIRENA (1450 patients)
LAMICTAL (1444 patients)
DURAGESIC-100 (1428 patients)
PREDNISOLONE (1427 patients)
PEGASYS (1417 patients)
POTASSIUM CHLORIDE (1394 patients)
PRISTIQ (1377 patients)
VALIUM (1376 patients)
YAZ (1340 patients)
LEVAQUIN (1333 patients)
ALPRAZOLAM (1322 patients)
DIGOXIN (1320 patients)
LANTUS (1318 patients)
ZYRTEC (1316 patients)
MULTI-VITAMIN (1309 patients)
CELEXA (1296 patients)
MULTI-VITAMINS (1283 patients)
LORTAB (1273 patients)
SPIRIVA (1246 patients)
BENADRYL (1242 patients)
YASMIN (1242 patients)
TRAZODONE HCL (1239 patients)
RIBAVIRIN (1216 patients)
TRAMADOL HCL (1213 patients)
GILENYA (1201 patients)
DEXAMETHASONE (1200 patients)
ZOFRAN (1176 patients)
DIAZEPAM (1172 patients)
METOPROLOL TARTRATE (1157 patients)
WARFARIN SODIUM (1133 patients)
OXYCODONE HCL (1127 patients)
AMLODIPINE (1117 patients)
TYLENOL (CAPLET) (1063 patients)
GLUCOPHAGE (1063 patients)
FLEXERIL (1058 patients)
VIAGRA (1056 patients)
TYLENOL (1047 patients)
ALLOPURINOL (1033 patients)
BETASERON (1032 patients)
DECADRON (1031 patients)
BACLOFEN (1027 patients)
FLONASE (1018 patients)
ALLEGRA (1017 patients)
INSULIN (1013 patients)
XOLAIR (1000 patients)
AMITRIPTYLINE HCL (995 patients)
ZANTAC (993 patients)
PRADAXA (989 patients)
FISH OIL (986 patients)
DEPAKOTE (976 patients)
ASCORBIC ACID (974 patients)
NUVARING (971 patients)
ZYPREXA (966 patients)
ALLI (964 patients)
MORPHINE (958 patients)
AMOXICILLIN (958 patients)
CLONIDINE (953 patients)
VITAMIN B-12 (911 patients)
STRATTERA (906 patients)
NITROGLYCERIN (888 patients)
COREG (887 patients)
CIALIS (886 patients)
VITAMIN E (883 patients)
BONIVA (879 patients)
COZAAR (877 patients)
RECLAST (874 patients)
IMITREX (868 patients)
LEVITRA (864 patients)
ACTOS (864 patients)
RISPERDAL (863 patients)
VALTREX (861 patients)
ZETIA (858 patients)
ACTONEL (855 patients)
METOPROLOL (850 patients)
LEVOXYL (849 patients)
MOTRIN (848 patients)
AVANDIA (840 patients)
CITALOPRAM HYDROBROMIDE (836 patients)
METFORMIN (833 patients)
TEGRETOL (832 patients)
PAROXETINE HCL (824 patients)
RANITIDINE (819 patients)
LUNESTA (812 patients)
NAPROXEN (809 patients)
CLARITIN (802 patients)
ORTHO EVRA (792 patients)
EXJADE (789 patients)
JANUVIA (788 patients)
ZITHROMAX (775 patients)
KEPPRA (774 patients)
ULTRAM (773 patients)
SPIRONOLACTONE (768 patients)
GLIPIZIDE (763 patients)
AVELOX (757 patients)
PEG-INTRON (748 patients)
FENTANYL (748 patients)
SYMBICORT (740 patients)
SOMA (739 patients)
GLYBURIDE (735 patients)
VITAMINS (723 patients)
REGLAN (723 patients)
ELAVIL (719 patients)
ALENDRONATE SODIUM (714 patients)
ALTACE (714 patients)
ABILIFY (708 patients)
CALCIUM CARBONATE (702 patients)
ACIPHEX (701 patients)
CYCLOPHOSPHAMIDE (698 patients)
LANSOPRAZOLE (696 patients)
ARIMIDEX (696 patients)
ALEVE (696 patients)
HYDROCODONE BITARTRATE (695 patients)
SIMCOR (691 patients)
HYDROCODONE (688 patients)
VERAPAMIL (682 patients)
BENICAR (680 patients)
PEPCID (673 patients)
CIPROFLOXACIN (667 patients)
LOVENOX (663 patients)
IRON (662 patients)
HUMALOG (660 patients)
WELLBUTRIN XL (659 patients)
PLAQUENIL (653 patients)
DILANTIN (653 patients)
FLOMAX (652 patients)
DILAUDID (650 patients)
BACTRIM (648 patients)
VICTOZA (648 patients)
GAMMAGARD LIQUID (647 patients)
BEXTRA (642 patients)
COPEGUS (637 patients)
ACYCLOVIR (634 patients)
PROMETHAZINE (632 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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