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

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, 17 individuals taking SORAFENIB (RAF KINASE INHIBITOR) reported HYPOTHYROIDISM 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 HYPOTHYROIDISM. In doing so, we compare SORAFENIB (RAF KINASE INHIBITOR) with other drugs that cause HYPOTHYROIDISM, to help you evaluate whether or not SORAFENIB (RAF KINASE INHIBITOR) causes HYPOTHYROIDISM. Likewise, this page shows the most highly-reported side effects of SORAFENIB (RAF KINASE INHIBITOR), so you can see if HYPOTHYROIDISM ranks among SORAFENIB (RAF KINASE INHIBITOR)'s most well-known side effects.
Summary Statistics
Reports of SORAFENIB (RAF KINASE INHIBITOR) causing HYPOTHYROIDISM: 17
Reports of any side effect of SORAFENIB (RAF KINASE INHIBITOR) : 3329
Percentage of SORAFENIB (RAF KINASE INHIBITOR) patients where HYPOTHYROIDISM is a reported side effect: 0.5107%

FDA reports of any drug causing HYPOTHYROIDISM : 10192
Average percentage for all medicated patients where HYPOTHYROIDISM is reported as a complication: 0.0639%

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 HYPOTHYROIDISM:

FOSAMAX (3889 patients)
SYNTHROID (1418 patients)
VIOXX (1276 patients)
ASPIRIN (1043 patients)
LEVOTHYROXINE SODIUM (1013 patients)
SEROQUEL (757 patients)
ZOMETA (632 patients)
LASIX (620 patients)
LIPITOR (543 patients)
NEXIUM (486 patients)
ZOLOFT (477 patients)
NEXAVAR (422 patients)
COUMADIN (404 patients)
ALENDRONATE SODIUM (389 patients)
PREMARIN (382 patients)
LEVOXYL (379 patients)
FOSAMAX PLUS D (376 patients)
PREDNISONE (371 patients)
AMBIEN (368 patients)
AREDIA (362 patients)
PRILOSEC (362 patients)
DIGOXIN (361 patients)
SUTENT (356 patients)
XANAX (356 patients)
ZOCOR (342 patients)
HYDROCHLOROTHIAZIDE (341 patients)
LISINOPRIL (341 patients)
FUROSEMIDE (330 patients)
PROTONIX (323 patients)
AVONEX (317 patients)
NEURONTIN (314 patients)
OMEPRAZOLE (306 patients)
SODIUM IODIDE I 131 (305 patients)
PAXIL (301 patients)
ATENOLOL (297 patients)
AMIODARONE HCL (285 patients)
ALBUTEROL (280 patients)
PREVACID (272 patients)
CELEBREX (268 patients)
POTASSIUM CHLORIDE (268 patients)
ACETAMINOPHEN (266 patients)
IBUPROFEN (256 patients)
SIMVASTATIN (255 patients)
ALLOPURINOL (255 patients)
RIBAVIRIN (251 patients)
NORVASC (246 patients)
WARFARIN SODIUM (245 patients)
PLAVIX (245 patients)
LYRICA (242 patients)
LEXAPRO (242 patients)
DURAGESIC-100 (240 patients)
BONIVA (237 patients)
MULTI-VITAMINS (234 patients)
ZYPREXA (232 patients)
FOLIC ACID (228 patients)
PEGASYS (227 patients)
ATIVAN (221 patients)
LEVAQUIN (220 patients)
PROZAC (218 patients)
VITAMINS (UNSPECIFIED) (218 patients)
VICODIN (217 patients)
EFFEXOR (215 patients)
TOPROL-XL (213 patients)
CALCIUM (UNSPECIFIED) (211 patients)
CYMBALTA (203 patients)
CLONAZEPAM (200 patients)
LORAZEPAM (199 patients)
CORDARONE (193 patients)
HEPARIN SODIUM INJECTION (192 patients)
[THERAPY UNSPECIFIED] (189 patients)
RISPERDAL (188 patients)
CELEXA (187 patients)
METHOTREXATE (182 patients)
VITAMIN D (179 patients)
LANTUS (176 patients)
OXYCONTIN (173 patients)
AMOXICILLIN (172 patients)
ACTONEL (170 patients)
SUNITINIB MALATE (169 patients)
ADVAIR DISKUS 100/50 (167 patients)
AMLODIPINE (164 patients)
DIOVAN (164 patients)
CRESTOR (163 patients)
LITHIUM CARBONATE (161 patients)
PERCOCET (157 patients)
LORTAB (157 patients)
ABILIFY (156 patients)
METFORMIN HCL (155 patients)
CHANTIX (154 patients)
VITAMIN E (154 patients)
REVLIMID (152 patients)
REBIF (152 patients)
ZOFRAN (150 patients)
ALLEGRA (149 patients)
DEXAMETHASONE (148 patients)
TRAZODONE HCL (147 patients)
METOPROLOL TARTRATE (146 patients)
WELLBUTRIN (145 patients)
HUMIRA (142 patients)
DECADRON (141 patients)
TAMOXIFEN CITRATE (140 patients)
NITROGLYCERIN (139 patients)
INSULIN (139 patients)
ENBREL (138 patients)
KLONOPIN (138 patients)
PREDNISONE TAB (136 patients)
CALCIUM (133 patients)
HUMALOG (133 patients)
RESTORIL (131 patients)
ASCORBIC ACID (131 patients)
ZANTAC (130 patients)
PEG-INTRON (129 patients)
NUVARING (128 patients)
DEPAKOTE (128 patients)
THYROID TAB (128 patients)
LAMICTAL (128 patients)
CALCIUM CARBONATE (127 patients)
FLEXERIL (127 patients)
VITAMIN D (UNSPECIFIED) (126 patients)
TYSABRI (126 patients)
VALIUM (126 patients)
BENADRYL (126 patients)
CLARITIN (124 patients)
CLINDAMYCIN (124 patients)
REGLAN (124 patients)
CLOZARIL (123 patients)
ALPRAZOLAM (123 patients)
FORTEO (116 patients)
ACYCLOVIR (116 patients)
ZYRTEC (116 patients)
GABAPENTIN (116 patients)
SPIRONOLACTONE (115 patients)
COPEGUS (115 patients)
COZAAR (115 patients)
MORPHINE (113 patients)
COREG (112 patients)
ZITHROMAX (111 patients)
AVANDIA (111 patients)
CEPHALEXIN (111 patients)
OXYCODONE HCL (109 patients)
FEMARA (108 patients)
REMICADE (108 patients)
EFFEXOR XR (108 patients)
ACCUTANE (107 patients)
ACTOS (106 patients)
REBETOL (106 patients)
ACIPHEX (105 patients)
CLONIDINE (103 patients)
PROMETHAZINE (102 patients)
FISH OIL (102 patients)
FLONASE (102 patients)
LEVOTHYROXINE (101 patients)
EVISTA (100 patients)
LOPRESSOR (100 patients)
PERIDEX (100 patients)
CLOZAPINE (100 patients)
GLUCOPHAGE (99 patients)
VANCOMYCIN (98 patients)
DIAZEPAM (98 patients)
ZESTRIL (98 patients)
FERROUS SULFATE TAB (98 patients)
METOPROLOL (97 patients)
VALPROATE SODIUM (97 patients)
PREMPRO (97 patients)
THALIDOMIDE (97 patients)
CARDIZEM (95 patients)
FAMOTIDINE (95 patients)
METOCLOPRAMIDE (94 patients)
CIPROFLOXACIN (94 patients)
SINGULAIR (94 patients)
RANITIDINE (94 patients)
TYLENOL (CAPLET) (93 patients)
TASIGNA (93 patients)
TRICOR (92 patients)
POTASSIUM (91 patients)
HEPARIN (90 patients)
MULTI-VITAMIN (90 patients)
XELODA (89 patients)
MOBIC (89 patients)
PROVERA (89 patients)
TEMAZEPAM (88 patients)
PROCRIT (88 patients)
ALTACE (87 patients)
ALDACTONE (87 patients)
LOMOTIL (87 patients)
VYTORIN (86 patients)
TRAMADOL HCL (86 patients)
NAPROXEN (85 patients)
RADIATION THERAPY (85 patients)
TOPAMAX (85 patients)
PREDNISOLONE (84 patients)
SPIRIVA (84 patients)
COLACE (84 patients)
RISPERIDONE (83 patients)
FLUCONAZOLE (83 patients)
PAROXETINE HCL (83 patients)
HYDROCODONE (82 patients)
NYSTATIN (82 patients)
GLEEVEC (82 patients)
HERCEPTIN (82 patients)
COMPAZINE (82 patients)
GLUCOSAMINE (81 patients)
DIPHENHYDRAMINE HCL (81 patients)
ARIMIDEX (80 patients)
CHEMOTHERAPEUTICS NOS (79 patients)
TEGRETOL (79 patients)
PHENERGAN (78 patients)
AZITHROMYCIN (78 patients)
BACLOFEN (78 patients)
KLOR-CON (77 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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