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

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, 36 individuals taking SORAFENIB (RAF KINASE INHIBITOR) reported INSOMNIA 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 INSOMNIA. In doing so, we compare SORAFENIB (RAF KINASE INHIBITOR) with other drugs that cause INSOMNIA, to help you evaluate whether or not SORAFENIB (RAF KINASE INHIBITOR) causes INSOMNIA. Likewise, this page shows the most highly-reported side effects of SORAFENIB (RAF KINASE INHIBITOR), so you can see if INSOMNIA ranks among SORAFENIB (RAF KINASE INHIBITOR)'s most well-known side effects.
Summary Statistics
Reports of SORAFENIB (RAF KINASE INHIBITOR) causing INSOMNIA: 36
Reports of any side effect of SORAFENIB (RAF KINASE INHIBITOR) : 3329
Percentage of SORAFENIB (RAF KINASE INHIBITOR) patients where INSOMNIA is a reported side effect: 1.0814%

FDA reports of any drug causing INSOMNIA : 76487
Average percentage for all medicated patients where INSOMNIA is reported as a complication: 0.4794%

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 INSOMNIA:

SEROQUEL (11960 patients)
FOSAMAX (6493 patients)
CHANTIX (6154 patients)
VIOXX (4629 patients)
ASPIRIN (4160 patients)
LUNESTA (3637 patients)
XANAX (3348 patients)
LYRICA (3093 patients)
CYMBALTA (2901 patients)
AMBIEN (2896 patients)
LIPITOR (2787 patients)
SYNTHROID (2761 patients)
PAXIL (2733 patients)
NEXIUM (2729 patients)
ZOLOFT (2588 patients)
NEURONTIN (2502 patients)
ACCUTANE (2491 patients)
SEROQUEL XR (2258 patients)
LISINOPRIL (2166 patients)
OXYCONTIN (1868 patients)
LEXAPRO (1821 patients)
AVONEX (1807 patients)
PREDNISONE (1805 patients)
KLONOPIN (1769 patients)
PRILOSEC (1748 patients)
ZOMETA (1698 patients)
ATIVAN (1684 patients)
ATENOLOL (1653 patients)
CELEBREX (1612 patients)
LASIX (1598 patients)
CLONAZEPAM (1560 patients)
DURAGESIC-100 (1535 patients)
WELLBUTRIN (1533 patients)
EFFEXOR (1518 patients)
SIMVASTATIN (1509 patients)
LEVAQUIN (1498 patients)
LORAZEPAM (1497 patients)
FORTEO (1463 patients)
HYDROCHLOROTHIAZIDE (1445 patients)
OMEPRAZOLE (1424 patients)
ALBUTEROL (1417 patients)
VICODIN (1393 patients)
CRESTOR (1375 patients)
PROZAC (1371 patients)
TYSABRI (1325 patients)
PREVACID (1304 patients)
RISPERDAL (1301 patients)
NORVASC (1300 patients)
PLAVIX (1289 patients)
ZOCOR (1288 patients)
VALIUM (1272 patients)
LAMICTAL (1271 patients)
PEGASYS (1261 patients)
TOPROL-XL (1259 patients)
COUMADIN (1255 patients)
SINGULAIR (1245 patients)
PROTONIX (1242 patients)
PRISTIQ (1227 patients)
IBUPROFEN (1224 patients)
EFFEXOR XR (1222 patients)
HEPARIN SODIUM INJECTION (1215 patients)
TRAZODONE HCL (1207 patients)
PERCOCET (1204 patients)
ZYPREXA (1195 patients)
LEVOTHYROXINE SODIUM (1175 patients)
ADVAIR DISKUS 100/50 (1161 patients)
GABAPENTIN (1153 patients)
ALPRAZOLAM (1148 patients)
AREDIA (1147 patients)
ENBREL (1145 patients)
VITAMIN D (1138 patients)
RIBAVIRIN (1137 patients)
ABILIFY (1109 patients)
FUROSEMIDE (1100 patients)
PREMARIN (1087 patients)
HUMIRA (1079 patients)
DIAZEPAM (1077 patients)
FOLIC ACID (1048 patients)
METFORMIN HCL (1006 patients)
CELEXA (973 patients)
SUBOXONE (970 patients)
DIOVAN (961 patients)
OXYCODONE HCL (960 patients)
CALCIUM (951 patients)
ACETAMINOPHEN (925 patients)
METHOTREXATE (900 patients)
DIGOXIN (900 patients)
LORTAB (886 patients)
ZYRTEC (879 patients)
NIASPAN (869 patients)
POTASSIUM CHLORIDE (860 patients)
TOPAMAX (854 patients)
DEPAKOTE (849 patients)
STRATTERA (814 patients)
FLEXERIL (808 patients)
GEODON (788 patients)
SPIRIVA (776 patients)
BENADRYL (734 patients)
FENTANYL (723 patients)
MULTI-VITAMINS (717 patients)
PAROXETINE HCL (707 patients)
ZANTAC (704 patients)
LEVOXYL (701 patients)
MORPHINE (700 patients)
METOPROLOL TARTRATE (700 patients)
PEG-INTRON (697 patients)
REMICADE (692 patients)
WELLBUTRIN XL (688 patients)
ALENDRONATE SODIUM (686 patients)
COPEGUS (683 patients)
TRAMADOL HCL (673 patients)
REBIF (658 patients)
ARIMIDEX (655 patients)
MULTI-VITAMIN (651 patients)
ELAVIL (640 patients)
SOMA (638 patients)
ALLEGRA (637 patients)
PREDNISONE TAB (634 patients)
WARFARIN SODIUM (633 patients)
LANTUS (614 patients)
CLONIDINE (612 patients)
REQUIP (607 patients)
ALLOPURINOL (607 patients)
ASCORBIC ACID (602 patients)
VITAMIN E (600 patients)
TEMAZEPAM (600 patients)
MIRTAZAPINE (598 patients)
DEXAMETHASONE (592 patients)
AMLODIPINE (591 patients)
ZOFRAN (583 patients)
LITHIUM CARBONATE (578 patients)
FISH OIL (574 patients)
BYETTA (569 patients)
FOSAMAX PLUS D (565 patients)
GLUCOPHAGE (562 patients)
METOPROLOL (559 patients)
AMITRIPTYLINE HCL (554 patients)
TYLENOL (552 patients)
VITAMIN B-12 (549 patients)
RESTORIL (544 patients)
VITAMINS (541 patients)
ULTRAM (537 patients)
BONIVA (536 patients)
INSULIN (534 patients)
COREG (533 patients)
BACLOFEN (531 patients)
CITALOPRAM HYDROBROMIDE (529 patients)
HYDROCODONE BITARTRATE (527 patients)
MIRAPEX (526 patients)
ZETIA (524 patients)
TYLENOL (CAPLET) (523 patients)
HYDROCODONE (521 patients)
ACTONEL (516 patients)
AVELOX (509 patients)
FLUOXETINE (508 patients)
AMOXICILLIN (503 patients)
DECADRON (501 patients)
ALL OTHER THERAPEUTIC PRODUCTS (499 patients)
FLONASE (499 patients)
FLOMAX (498 patients)
CIPROFLOXACIN (495 patients)
DILAUDID (495 patients)
METFORMIN (494 patients)
NAPROXEN (493 patients)
REMERON (491 patients)
ACTOS (489 patients)
ZOLPIDEM (489 patients)
ZITHROMAX (486 patients)
TEGRETOL (484 patients)
COZAAR (475 patients)
CLARITIN (475 patients)
NITROGLYCERIN (473 patients)
PAXIL CR (470 patients)
CHAMPIX (468 patients)
ACIPHEX (461 patients)
FENTANYL-100 (459 patients)
REVLIMID (459 patients)
RANITIDINE (456 patients)
TRICOR (450 patients)
BEXTRA (450 patients)
MOTRIN (446 patients)
REGLAN (443 patients)
PREDNISOLONE (441 patients)
MORPHINE SULFATE (440 patients)
ALTACE (439 patients)
SYMBICORT (435 patients)
ZOLPIDEM TARTRATE (433 patients)
PROMETHAZINE (413 patients)
COLACE (413 patients)
[THERAPY UNSPECIFIED] (406 patients)
VYVANSE (406 patients)
ACETYLSALICYLIC ACID (404 patients)
HALDOL (402 patients)
XYREM (402 patients)
PEPCID (401 patients)
GLIPIZIDE (397 patients)
GLYBURIDE (396 patients)
POTASSIUM (395 patients)
SERTRALINE HYDROCHLORIDE (391 patients)
RISPERIDONE (388 patients)
BENICAR (384 patients)
BETASERON (380 patients)
NAMENDA (379 patients)
AVANDIA (378 patients)
SPIRONOLACTONE (377 patients)
KEPPRA (375 patients)
VYTORIN (375 patients)
NICODERM CQ (373 patients)
SANDOSTATIN LAR (372 patients)
HUMALOG (372 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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