Please choose an event type to view the corresponding MedsFacts report:

PAIN ( 77 FDA reports)
FATIGUE ( 52 FDA reports)
DYSPNOEA ( 49 FDA reports)
ANXIETY ( 47 FDA reports)
HYPERTENSION ( 42 FDA reports)
GAIT DISTURBANCE ( 40 FDA reports)
GASTROOESOPHAGEAL REFLUX DISEASE ( 40 FDA reports)
OSTEONECROSIS OF JAW ( 40 FDA reports)
CHEST PAIN ( 39 FDA reports)
DEPRESSION ( 39 FDA reports)
ASTHENIA ( 38 FDA reports)
MALAISE ( 38 FDA reports)
PULMONARY EMBOLISM ( 38 FDA reports)
URINARY TRACT INFECTION ( 37 FDA reports)
OSTEOPOROSIS ( 35 FDA reports)
CONVULSION ( 34 FDA reports)
FALL ( 34 FDA reports)
ANAEMIA ( 33 FDA reports)
DEEP VEIN THROMBOSIS ( 33 FDA reports)
OSTEOMYELITIS ( 33 FDA reports)
INJURY ( 32 FDA reports)
OSTEITIS ( 32 FDA reports)
DIARRHOEA ( 31 FDA reports)
DIZZINESS ( 31 FDA reports)
GINGIVITIS ( 31 FDA reports)
CEREBROVASCULAR ACCIDENT ( 30 FDA reports)
OEDEMA PERIPHERAL ( 30 FDA reports)
VISUAL ACUITY REDUCED ( 29 FDA reports)
ATRIAL FIBRILLATION ( 28 FDA reports)
BLOOD CREATININE INCREASED ( 28 FDA reports)
EMOTIONAL DISTRESS ( 27 FDA reports)
NAUSEA ( 27 FDA reports)
CARDIAC FAILURE ( 26 FDA reports)
MUSCLE SPASMS ( 26 FDA reports)
PERIODONTITIS ( 26 FDA reports)
RENAL FAILURE ACUTE ( 26 FDA reports)
SURGERY ( 25 FDA reports)
ARTHRALGIA ( 24 FDA reports)
HEADACHE ( 24 FDA reports)
MYALGIA ( 24 FDA reports)
WEIGHT DECREASED ( 24 FDA reports)
CARDIOVASCULAR DISORDER ( 23 FDA reports)
CARPAL TUNNEL SYNDROME ( 23 FDA reports)
GASTROINTESTINAL HAEMORRHAGE ( 23 FDA reports)
HAEMATURIA ( 23 FDA reports)
PLEURAL EFFUSION ( 23 FDA reports)
VISION BLURRED ( 23 FDA reports)
TYPE 2 DIABETES MELLITUS ( 22 FDA reports)
VOMITING ( 22 FDA reports)
ANGINA PECTORIS ( 21 FDA reports)
ANHEDONIA ( 21 FDA reports)
BLOOD PRESSURE INCREASED ( 21 FDA reports)
DEFORMITY ( 21 FDA reports)
DISABILITY ( 21 FDA reports)
DYSKINESIA ( 21 FDA reports)
DYSLIPIDAEMIA ( 21 FDA reports)
EMPHYSEMA ( 21 FDA reports)
FRACTURE NONUNION ( 21 FDA reports)
HALLUCINATION ( 21 FDA reports)
HYPOAESTHESIA ( 21 FDA reports)
INTERVERTEBRAL DISC DEGENERATION ( 21 FDA reports)
IRON DEFICIENCY ANAEMIA ( 21 FDA reports)
JAW FRACTURE ( 21 FDA reports)
PAIN IN JAW ( 21 FDA reports)
PATHOLOGICAL FRACTURE ( 21 FDA reports)
POST PROCEDURAL FISTULA ( 21 FDA reports)
PYREXIA ( 21 FDA reports)
QUADRIPLEGIA ( 21 FDA reports)
SLEEP APNOEA SYNDROME ( 21 FDA reports)
TOOTH EXTRACTION ( 21 FDA reports)
VULVOVAGINAL CANDIDIASIS ( 21 FDA reports)
ATELECTASIS ( 20 FDA reports)
DYSPHAGIA ( 20 FDA reports)
PERIODONTAL DISEASE ( 20 FDA reports)
PURULENT DISCHARGE ( 20 FDA reports)
SWELLING FACE ( 20 FDA reports)
BONE CALLUS EXCESSIVE ( 19 FDA reports)
BRADYCARDIA ( 19 FDA reports)
BRUXISM ( 19 FDA reports)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE ( 19 FDA reports)
DENTAL CARIES ( 19 FDA reports)
PAIN IN EXTREMITY ( 19 FDA reports)
RENAL FAILURE CHRONIC ( 19 FDA reports)
RENAL IMPAIRMENT ( 19 FDA reports)
SINUS TACHYCARDIA ( 19 FDA reports)
SYNCOPE ( 19 FDA reports)
BONE OPERATION ( 18 FDA reports)
CELLULITIS ( 18 FDA reports)
DEBRIDEMENT ( 18 FDA reports)
ORAL CAVITY FISTULA ( 18 FDA reports)
PULMONARY OEDEMA ( 18 FDA reports)
SEPSIS ( 18 FDA reports)
ARRHYTHMIA ( 17 FDA reports)
CRANIAL NERVE DISORDER ( 17 FDA reports)
GASTRITIS ( 17 FDA reports)
HAEMATEMESIS ( 17 FDA reports)
HYPERKALAEMIA ( 17 FDA reports)
HYPOTENSION ( 17 FDA reports)
LEFT VENTRICULAR HYPERTROPHY ( 17 FDA reports)
MUSCLE STRAIN ( 17 FDA reports)
PANIC ATTACK ( 17 FDA reports)
PNEUMONIA ( 17 FDA reports)
ALANINE AMINOTRANSFERASE INCREASED ( 16 FDA reports)
ASPARTATE AMINOTRANSFERASE INCREASED ( 16 FDA reports)
C-REACTIVE PROTEIN INCREASED ( 16 FDA reports)
DEATH ( 16 FDA reports)
DRUG INEFFECTIVE ( 16 FDA reports)
DYSARTHRIA ( 16 FDA reports)
HAEMOPTYSIS ( 16 FDA reports)
IMPAIRED GASTRIC EMPTYING ( 16 FDA reports)
INFECTION ( 16 FDA reports)
INTERVERTEBRAL DISC SPACE NARROWING ( 16 FDA reports)
OVERDOSE ( 16 FDA reports)
BLOOD GLUCOSE DECREASED ( 15 FDA reports)
BLOOD GLUCOSE INCREASED ( 15 FDA reports)
EMBOLISM ( 15 FDA reports)
INTERNATIONAL NORMALISED RATIO INCREASED ( 15 FDA reports)
PROTHROMBIN TIME PROLONGED ( 15 FDA reports)
PRURITUS ( 15 FDA reports)
STRESS ( 15 FDA reports)
TACHYCARDIA ( 15 FDA reports)
VENOUS INSUFFICIENCY ( 15 FDA reports)
ACTIVITIES OF DAILY LIVING IMPAIRED ( 14 FDA reports)
COUGH ( 14 FDA reports)
CYTOMEGALOVIRUS INFECTION ( 14 FDA reports)
GOITRE ( 14 FDA reports)
HIATUS HERNIA ( 14 FDA reports)
HYPOXIA ( 14 FDA reports)
OSTEONECROSIS ( 14 FDA reports)
PALPITATIONS ( 14 FDA reports)
SPINAL DISORDER ( 14 FDA reports)
ADENOCARCINOMA ( 13 FDA reports)
BLOOD CHOLESTEROL INCREASED ( 13 FDA reports)
CORONARY ARTERY DISEASE ( 13 FDA reports)
TOOTH ABSCESS ( 13 FDA reports)
BALANCE DISORDER ( 12 FDA reports)
DYSPEPSIA ( 12 FDA reports)
ELECTROLYTE IMBALANCE ( 12 FDA reports)
FIBROMYALGIA ( 12 FDA reports)
HEPATIC STEATOSIS ( 12 FDA reports)
HYPONATRAEMIA ( 12 FDA reports)
LEUKOCYTOSIS ( 12 FDA reports)
LUNG NEOPLASM ( 12 FDA reports)
MASTICATION DISORDER ( 12 FDA reports)
OEDEMA ( 12 FDA reports)
OSTEOARTHRITIS ( 12 FDA reports)
OTITIS MEDIA ( 12 FDA reports)
THROMBOCYTOPENIA ( 12 FDA reports)
VAGINAL HAEMORRHAGE ( 12 FDA reports)
ADRENAL DISORDER ( 11 FDA reports)
BLISTER ( 11 FDA reports)
BONE LOSS ( 11 FDA reports)
CARDIAC FAILURE CONGESTIVE ( 11 FDA reports)
CATARACT NUCLEAR ( 11 FDA reports)
CHRONIC SINUSITIS ( 11 FDA reports)
CLAUSTROPHOBIA ( 11 FDA reports)
COLITIS ULCERATIVE ( 11 FDA reports)
CROHN'S DISEASE ( 11 FDA reports)
DIARRHOEA HAEMORRHAGIC ( 11 FDA reports)
DIVERTICULITIS ( 11 FDA reports)
DRUG WITHDRAWAL SYNDROME ( 11 FDA reports)
DUODENITIS ( 11 FDA reports)
EXOPHTHALMOS ( 11 FDA reports)
EXPOSED BONE IN JAW ( 11 FDA reports)
HAEMOGLOBIN DECREASED ( 11 FDA reports)
ILEUS ( 11 FDA reports)
INCREASED BRONCHIAL SECRETION ( 11 FDA reports)
INSOMNIA ( 11 FDA reports)
INTERVERTEBRAL DISC DISORDER ( 11 FDA reports)
INTERVERTEBRAL DISC PROTRUSION ( 11 FDA reports)
LACRIMATION INCREASED ( 11 FDA reports)
LAGOPHTHALMOS ( 11 FDA reports)
LIVER DISORDER ( 11 FDA reports)
LYMPHADENOPATHY ( 11 FDA reports)
MYOPIA ( 11 FDA reports)
NEOPLASM MALIGNANT ( 11 FDA reports)
OBSTRUCTIVE AIRWAYS DISORDER ( 11 FDA reports)
OESOPHAGITIS ( 11 FDA reports)
ONYCHOMYCOSIS ( 11 FDA reports)
OSTEOLYSIS ( 11 FDA reports)
PRIMARY SEQUESTRUM ( 11 FDA reports)
PROTEINURIA ( 11 FDA reports)
QUALITY OF LIFE DECREASED ( 11 FDA reports)
RESPIRATORY FAILURE ( 11 FDA reports)
SKIN ULCER ( 11 FDA reports)
SOMNOLENCE ( 11 FDA reports)
STREPTOCOCCAL INFECTION ( 11 FDA reports)
THROMBOSIS ( 11 FDA reports)
TOOTH LOSS ( 11 FDA reports)
WALKING AID USER ( 11 FDA reports)
WEIGHT INCREASED ( 11 FDA reports)
BLUE TOE SYNDROME ( 10 FDA reports)
CAROTID ARTERY STENOSIS ( 10 FDA reports)
DECREASED APPETITE ( 10 FDA reports)
DRUG INTERACTION ( 10 FDA reports)
GINGIVAL PAIN ( 10 FDA reports)
HAEMATOCHEZIA ( 10 FDA reports)
HAEMATOMA ( 10 FDA reports)
LIMB INJURY ( 10 FDA reports)
MITRAL VALVE INCOMPETENCE ( 10 FDA reports)
MYOCARDIAL INFARCTION ( 10 FDA reports)
ORAL PAIN ( 10 FDA reports)
PHYSICAL DISABILITY ( 10 FDA reports)
SPEECH DISORDER ( 10 FDA reports)
ULCER ( 10 FDA reports)
VISUAL IMPAIRMENT ( 10 FDA reports)
APHASIA ( 9 FDA reports)
APNOEA ( 9 FDA reports)
BONE CYST ( 9 FDA reports)
CEREBRAL HAEMORRHAGE ( 9 FDA reports)
EAR DISCOMFORT ( 9 FDA reports)
EAR HAEMORRHAGE ( 9 FDA reports)
ELECTROCARDIOGRAM QRS COMPLEX PROLONGED ( 9 FDA reports)
EPISTAXIS ( 9 FDA reports)
EXCORIATION ( 9 FDA reports)
HIP DEFORMITY ( 9 FDA reports)
KERATOCONJUNCTIVITIS SICCA ( 9 FDA reports)
LOCALISED INFECTION ( 9 FDA reports)
METATARSUS PRIMUS VARUS ( 9 FDA reports)
NERVOUSNESS ( 9 FDA reports)
OSTEOPENIA ( 9 FDA reports)
PARAESTHESIA ( 9 FDA reports)
PINGUECULA ( 9 FDA reports)
PNEUMONIA ASPIRATION ( 9 FDA reports)
POLYOMAVIRUS-ASSOCIATED NEPHROPATHY ( 9 FDA reports)
POOR PERIPHERAL CIRCULATION ( 9 FDA reports)
PULSE ABSENT ( 9 FDA reports)
RESPIRATORY DISTRESS ( 9 FDA reports)
RHINORRHOEA ( 9 FDA reports)
SPINAL OSTEOARTHRITIS ( 9 FDA reports)
SUBCUTANEOUS ABSCESS ( 9 FDA reports)
THINKING ABNORMAL ( 9 FDA reports)
VIITH NERVE PARALYSIS ( 9 FDA reports)
AGRANULOCYTOSIS ( 8 FDA reports)
ALOPECIA ( 8 FDA reports)
BENIGN GASTRIC NEOPLASM ( 8 FDA reports)
BLOOD POTASSIUM INCREASED ( 8 FDA reports)
BLOOD PRESSURE DECREASED ( 8 FDA reports)
CATARACT ( 8 FDA reports)
CEREBRAL ISCHAEMIA ( 8 FDA reports)
CHOLELITHIASIS ( 8 FDA reports)
CONSTIPATION ( 8 FDA reports)
DEHYDRATION ( 8 FDA reports)
DIVERTICULUM ( 8 FDA reports)
DYSPNOEA EXERTIONAL ( 8 FDA reports)
HAEMORRHOIDS ( 8 FDA reports)
HYDRONEPHROSIS ( 8 FDA reports)
HYPERSOMNIA ( 8 FDA reports)
LUNG DISORDER ( 8 FDA reports)
LYMPHOCELE ( 8 FDA reports)
MENTAL DISORDER ( 8 FDA reports)
METASTASES TO BONE ( 8 FDA reports)
METASTASES TO SKIN ( 8 FDA reports)
NEPHROSTOMY TUBE PLACEMENT ( 8 FDA reports)
PERIPHERAL VASCULAR DISORDER ( 8 FDA reports)
RENAL FAILURE ( 8 FDA reports)
SINUS ARRHYTHMIA ( 8 FDA reports)
TINEA PEDIS ( 8 FDA reports)
URETERIC OBSTRUCTION ( 8 FDA reports)
VENOUS THROMBOSIS ( 8 FDA reports)
ACUTE CORONARY SYNDROME ( 7 FDA reports)
ARTERIOSCLEROSIS ( 7 FDA reports)
ARTHRITIS ( 7 FDA reports)
ASPERGILLOSIS ( 7 FDA reports)
ASTHMA ( 7 FDA reports)
BLOOD PRESSURE SYSTOLIC INCREASED ( 7 FDA reports)
CARDIAC PACEMAKER INSERTION ( 7 FDA reports)
CHOLESTASIS ( 7 FDA reports)
CYTOLYTIC HEPATITIS ( 7 FDA reports)
EMBOLISM ARTERIAL ( 7 FDA reports)
EPILEPSY ( 7 FDA reports)
EXTRASKELETAL OSSIFICATION ( 7 FDA reports)
GENERAL PHYSICAL HEALTH DETERIORATION ( 7 FDA reports)
HAEMORRHAGE INTRACRANIAL ( 7 FDA reports)
HEPATIC CIRRHOSIS ( 7 FDA reports)
HYPOGLYCAEMIA ( 7 FDA reports)
ILIUM FRACTURE ( 7 FDA reports)
INTRACRANIAL HAEMATOMA ( 7 FDA reports)
JAUNDICE ( 7 FDA reports)
LACTIC ACIDOSIS ( 7 FDA reports)
LIVER TRANSPLANT ( 7 FDA reports)
NEOPLASM PROGRESSION ( 7 FDA reports)
PORTAL HYPERTENSION ( 7 FDA reports)
RESPIRATORY TRACT INFECTION BACTERIAL ( 7 FDA reports)
REVERSIBLE AIRWAYS OBSTRUCTION ( 7 FDA reports)
SCOLIOSIS ( 7 FDA reports)
STAPHYLOCOCCAL INFECTION ( 7 FDA reports)
THROMBOPHLEBITIS ( 7 FDA reports)
VARICES OESOPHAGEAL ( 7 FDA reports)
ABDOMINAL PAIN UPPER ( 6 FDA reports)
BACK PAIN ( 6 FDA reports)
BLOOD POTASSIUM DECREASED ( 6 FDA reports)
BLOOD UREA INCREASED ( 6 FDA reports)
CANDIDIASIS ( 6 FDA reports)
COAGULOPATHY ( 6 FDA reports)
CONDITION AGGRAVATED ( 6 FDA reports)
DECUBITUS ULCER ( 6 FDA reports)
DISEASE PROGRESSION ( 6 FDA reports)
DRY EYE ( 6 FDA reports)
FEELING COLD ( 6 FDA reports)
FEELING HOT ( 6 FDA reports)
FLUID INTAKE REDUCED ( 6 FDA reports)
GASTROENTERITIS ( 6 FDA reports)
JOINT DISLOCATION ( 6 FDA reports)
LOSS OF CONSCIOUSNESS ( 6 FDA reports)
MEDICAL DEVICE COMPLICATION ( 6 FDA reports)
MUSCLE TWITCHING ( 6 FDA reports)
MUSCULOSKELETAL PAIN ( 6 FDA reports)
NASAL CONGESTION ( 6 FDA reports)
OVERWEIGHT ( 6 FDA reports)
PSEUDOMONAS INFECTION ( 6 FDA reports)
TOOTHACHE ( 6 FDA reports)
TRACHEAL OPERATION ( 6 FDA reports)
TRANSPLANT REJECTION ( 6 FDA reports)
ABDOMINAL DISTENSION ( 5 FDA reports)
ALBUMIN URINE PRESENT ( 5 FDA reports)
ANGIOPLASTY ( 5 FDA reports)
ANOREXIA ( 5 FDA reports)
ARTERIAL DISORDER ( 5 FDA reports)
ATRIAL FLUTTER ( 5 FDA reports)
ATRIOVENTRICULAR BLOCK COMPLETE ( 5 FDA reports)
BLOOD ALKALINE PHOSPHATASE INCREASED ( 5 FDA reports)
CARDIOMEGALY ( 5 FDA reports)
CONTUSION ( 5 FDA reports)
CREATININE URINE INCREASED ( 5 FDA reports)
DEMENTIA ( 5 FDA reports)
DYSSTASIA ( 5 FDA reports)
ELECTROCARDIOGRAM QRS COMPLEX SHORTENED ( 5 FDA reports)
ELECTROCARDIOGRAM QT SHORTENED ( 5 FDA reports)
ENCEPHALITIS VIRAL ( 5 FDA reports)
EXTRAPYRAMIDAL DISORDER ( 5 FDA reports)
EYE DISORDER ( 5 FDA reports)
GLAUCOMA ( 5 FDA reports)
GLYCOSYLATED HAEMOGLOBIN INCREASED ( 5 FDA reports)
HYPERTENSIVE CRISIS ( 5 FDA reports)
HYPERURICAEMIA ( 5 FDA reports)
HYPOTHYROIDISM ( 5 FDA reports)
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION ( 5 FDA reports)
INFLAMMATION ( 5 FDA reports)
INTRA-ABDOMINAL HAEMATOMA ( 5 FDA reports)
ISCHAEMIA ( 5 FDA reports)
LIGAMENT LAXITY ( 5 FDA reports)
PANCREATITIS ( 5 FDA reports)
PULMONARY HYPERTENSION ( 5 FDA reports)
RHEUMATOID ARTHRITIS ( 5 FDA reports)
SICKLE CELL ANAEMIA WITH CRISIS ( 5 FDA reports)
SQUAMOUS CELL CARCINOMA ( 5 FDA reports)
TERMINAL STATE ( 5 FDA reports)
VARICOSE VEIN ( 5 FDA reports)
VITREOUS HAEMORRHAGE ( 5 FDA reports)
VULVOVAGINAL PAIN ( 5 FDA reports)
ANGIOGRAM ( 4 FDA reports)
BACTERAEMIA ( 4 FDA reports)
BASAL CELL CARCINOMA ( 4 FDA reports)
BLINDNESS ( 4 FDA reports)
BLOOD BILIRUBIN INCREASED ( 4 FDA reports)
BLOOD DISORDER ( 4 FDA reports)
BLOOD PRESSURE DIASTOLIC DECREASED ( 4 FDA reports)
BLOOD SODIUM DECREASED ( 4 FDA reports)
BLOOD THYROID STIMULATING HORMONE INCREASED ( 4 FDA reports)
BLOOD TRIGLYCERIDES INCREASED ( 4 FDA reports)
CARDIAC ARREST ( 4 FDA reports)
CARDIO-RESPIRATORY ARREST ( 4 FDA reports)
COGNITIVE DISORDER ( 4 FDA reports)
COLITIS COLLAGENOUS ( 4 FDA reports)
COMPLICATION OF DEVICE INSERTION ( 4 FDA reports)
CONFUSIONAL STATE ( 4 FDA reports)
DERMATITIS CONTACT ( 4 FDA reports)
DIPLOPIA ( 4 FDA reports)
DISTURBANCE IN ATTENTION ( 4 FDA reports)
ENCEPHALOMALACIA ( 4 FDA reports)
ERECTILE DYSFUNCTION ( 4 FDA reports)
ESCHERICHIA INFECTION ( 4 FDA reports)
FAECES DISCOLOURED ( 4 FDA reports)
GASTRIC ULCER ( 4 FDA reports)
HEART RATE DECREASED ( 4 FDA reports)
HEART RATE INCREASED ( 4 FDA reports)
HEPATOCELLULAR INJURY ( 4 FDA reports)
ISCHAEMIC STROKE ( 4 FDA reports)
JOINT INJURY ( 4 FDA reports)
LEFT VENTRICULAR FAILURE ( 4 FDA reports)
LIBIDO DECREASED ( 4 FDA reports)
MALIGNANT MELANOMA IN SITU ( 4 FDA reports)
MULTI-ORGAN FAILURE ( 4 FDA reports)
MUSCULAR WEAKNESS ( 4 FDA reports)
NEUROPATHY PERIPHERAL ( 4 FDA reports)
NIGHT SWEATS ( 4 FDA reports)
OFF LABEL USE ( 4 FDA reports)
RETINAL DETACHMENT ( 4 FDA reports)
RETINAL HAEMORRHAGE ( 4 FDA reports)
RETINOPATHY ( 4 FDA reports)
RHABDOMYOLYSIS ( 4 FDA reports)
SICK SINUS SYNDROME ( 4 FDA reports)
SUPRAVENTRICULAR EXTRASYSTOLES ( 4 FDA reports)
VENTRICULAR EXTRASYSTOLES ( 4 FDA reports)
VENTRICULAR TACHYCARDIA ( 4 FDA reports)
VITREOUS DETACHMENT ( 4 FDA reports)
XEROSIS ( 4 FDA reports)
ABDOMINAL PAIN ( 3 FDA reports)
ACUTE MYOCARDIAL INFARCTION ( 3 FDA reports)
AGITATION ( 3 FDA reports)
ATAXIA ( 3 FDA reports)
BLOOD ALBUMIN DECREASED ( 3 FDA reports)
BLOOD PRESSURE DIASTOLIC INCREASED ( 3 FDA reports)
BONE LESION ( 3 FDA reports)
BONE NEOPLASM MALIGNANT ( 3 FDA reports)
BRAIN NATRIURETIC PEPTIDE INCREASED ( 3 FDA reports)
CARDIOGENIC SHOCK ( 3 FDA reports)
CEREBRAL INFARCTION ( 3 FDA reports)
CLOSTRIDIAL INFECTION ( 3 FDA reports)
COMPRESSION FRACTURE ( 3 FDA reports)
CORONARY ARTERY STENOSIS ( 3 FDA reports)
CREATININE RENAL CLEARANCE DECREASED ( 3 FDA reports)
CREPITATIONS ( 3 FDA reports)
DENTURE WEARER ( 3 FDA reports)
DIABETES MELLITUS ( 3 FDA reports)
DIFFUSE LARGE B-CELL LYMPHOMA ( 3 FDA reports)
DISEASE RECURRENCE ( 3 FDA reports)
DRUG INTOLERANCE ( 3 FDA reports)
DUODENAL ULCER ( 3 FDA reports)
ECCHYMOSIS ( 3 FDA reports)
EOSINOPHILIA ( 3 FDA reports)
EXERCISE TOLERANCE DECREASED ( 3 FDA reports)
FACIAL PALSY ( 3 FDA reports)
FEELING ABNORMAL ( 3 FDA reports)
FEMORAL ARTERY OCCLUSION ( 3 FDA reports)
GAMMA-GLUTAMYLTRANSFERASE INCREASED ( 3 FDA reports)
GASTRITIS EROSIVE ( 3 FDA reports)
HAEMODIALYSIS ( 3 FDA reports)
HEMIPLEGIA ( 3 FDA reports)
HEPATOCELLULAR DAMAGE ( 3 FDA reports)
HERNIA REPAIR ( 3 FDA reports)
HERPES ZOSTER ( 3 FDA reports)
HOT FLUSH ( 3 FDA reports)
HYPERLIPASAEMIA ( 3 FDA reports)
HYPOCALCAEMIA ( 3 FDA reports)
HYPOGONADISM ( 3 FDA reports)
HYPOTHERMIA ( 3 FDA reports)
HYPOVOLAEMIA ( 3 FDA reports)
INGUINAL HERNIA, OBSTRUCTIVE ( 3 FDA reports)
KYPHOSIS ( 3 FDA reports)
LEFT ATRIAL DILATATION ( 3 FDA reports)
LETHARGY ( 3 FDA reports)
METASTASES TO CENTRAL NERVOUS SYSTEM ( 3 FDA reports)
MOTOR DYSFUNCTION ( 3 FDA reports)
MUSCULOSKELETAL CHEST PAIN ( 3 FDA reports)
MUSCULOSKELETAL STIFFNESS ( 3 FDA reports)
MYOCARDIAL ISCHAEMIA ( 3 FDA reports)
NEPHROPATHY ( 3 FDA reports)
OBESITY ( 3 FDA reports)
OESOPHAGEAL ULCER ( 3 FDA reports)
ORCHIDECTOMY ( 3 FDA reports)
PANCREATITIS ACUTE ( 3 FDA reports)
PERICARDIAL EFFUSION ( 3 FDA reports)
PERIPHLEBITIS ( 3 FDA reports)
PLATELET COUNT INCREASED ( 3 FDA reports)
PULMONARY INFARCTION ( 3 FDA reports)
PULMONARY VALVE INCOMPETENCE ( 3 FDA reports)
RIGHT VENTRICULAR FAILURE ( 3 FDA reports)
SENSORY LOSS ( 3 FDA reports)
SINOATRIAL BLOCK ( 3 FDA reports)
SKIN GRAFT ( 3 FDA reports)
SKIN NECROSIS ( 3 FDA reports)
SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE ( 3 FDA reports)
SQUAMOUS CELL CARCINOMA OF SKIN ( 3 FDA reports)
TACHYARRHYTHMIA ( 3 FDA reports)
TRICUSPID VALVE INCOMPETENCE ( 3 FDA reports)
URINARY TRACT INFECTION PSEUDOMONAL ( 3 FDA reports)
VASCULAR GRAFT ( 3 FDA reports)
VENOUS STASIS ( 3 FDA reports)
WHITE BLOOD CELL COUNT INCREASED ( 3 FDA reports)
WOUND ( 3 FDA reports)
WRONG TECHNIQUE IN DRUG USAGE PROCESS ( 3 FDA reports)
ABASIA ( 2 FDA reports)
ABDOMINAL HAEMATOMA ( 2 FDA reports)
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED ( 2 FDA reports)
AGRAPHIA ( 2 FDA reports)
ANEURYSMECTOMY ( 2 FDA reports)
ANGIOPATHY ( 2 FDA reports)
AORTIC DISSECTION ( 2 FDA reports)
AORTIC VALVE REPLACEMENT ( 2 FDA reports)
ARTHROPATHY ( 2 FDA reports)
ASEPTIC NECROSIS BONE ( 2 FDA reports)
BLADDER CANCER ( 2 FDA reports)
BLOOD CREATINE PHOSPHOKINASE INCREASED ( 2 FDA reports)
BLOOD CREATINE PHOSPHOKINASE MB INCREASED ( 2 FDA reports)
BLOOD FIBRINOGEN INCREASED ( 2 FDA reports)
BLOOD PHOSPHORUS DECREASED ( 2 FDA reports)
BLOOD PRESSURE FLUCTUATION ( 2 FDA reports)
BLOOD PRESSURE INADEQUATELY CONTROLLED ( 2 FDA reports)
BONE DISORDER ( 2 FDA reports)
BONE INFECTION ( 2 FDA reports)
BONE MARROW FAILURE ( 2 FDA reports)
BREAST CANCER ( 2 FDA reports)
BRONCHITIS ( 2 FDA reports)
BURNING SENSATION ( 2 FDA reports)
CARDIAC DISORDER ( 2 FDA reports)
CARDIOVERSION ( 2 FDA reports)
CHOLECYSTECTOMY ( 2 FDA reports)
COMA ( 2 FDA reports)
CORNEAL OEDEMA ( 2 FDA reports)
CORONARY ARTERY OCCLUSION ( 2 FDA reports)
CORONARY ARTERY THROMBOSIS ( 2 FDA reports)
DELIRIUM ( 2 FDA reports)
DEMENTIA WITH LEWY BODIES ( 2 FDA reports)
DEPENDENCE ( 2 FDA reports)
DERMATOPHYTOSIS ( 2 FDA reports)
DETACHMENT OF RETINAL PIGMENT EPITHELIUM ( 2 FDA reports)
DYSPHONIA ( 2 FDA reports)
DYSTONIA ( 2 FDA reports)
EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER ( 2 FDA reports)
ERYTHEMA ( 2 FDA reports)
EYE HAEMORRHAGE ( 2 FDA reports)
EYELID PTOSIS ( 2 FDA reports)
FLATULENCE ( 2 FDA reports)
GALLBLADDER ENLARGEMENT ( 2 FDA reports)
GASTRIC HAEMORRHAGE ( 2 FDA reports)
GASTROENTERITIS VIRAL ( 2 FDA reports)
GASTROINTESTINAL STROMAL TUMOUR ( 2 FDA reports)
GASTROSTOMY ( 2 FDA reports)
GENERAL PHYSICAL CONDITION ABNORMAL ( 2 FDA reports)
GINGIVAL DISORDER ( 2 FDA reports)
HAEMATOCRIT DECREASED ( 2 FDA reports)
HAEMORRHAGE ( 2 FDA reports)
HAEMORRHAGE URINARY TRACT ( 2 FDA reports)
HEAD INJURY ( 2 FDA reports)
HEMIPARESIS ( 2 FDA reports)
HEPATIC CYST ( 2 FDA reports)
HIGH DENSITY LIPOPROTEIN DECREASED ( 2 FDA reports)
HIP FRACTURE ( 2 FDA reports)
HYPERCHOLESTEROLAEMIA ( 2 FDA reports)
HYPERGLYCAEMIA ( 2 FDA reports)
HYPERVENTILATION ( 2 FDA reports)
HYPOAESTHESIA FACIAL ( 2 FDA reports)
HYPOKALAEMIA ( 2 FDA reports)
INFARCTION ( 2 FDA reports)
INJECTION SITE HAEMORRHAGE ( 2 FDA reports)
INTESTINAL HAEMORRHAGE ( 2 FDA reports)
INTRACARDIAC THROMBUS ( 2 FDA reports)
KIDNEY TRANSPLANT REJECTION ( 2 FDA reports)
KNEE OPERATION ( 2 FDA reports)
LAPAROSCOPIC SURGERY ( 2 FDA reports)
LEARNING DISORDER ( 2 FDA reports)
LOCAL SWELLING ( 2 FDA reports)
LYMPHOCYTE COUNT DECREASED ( 2 FDA reports)
LYMPHOEDEMA ( 2 FDA reports)
MELAENA ( 2 FDA reports)
METABOLIC ALKALOSIS ( 2 FDA reports)
METAMORPHOPSIA ( 2 FDA reports)
NASAL MUCOSAL DISORDER ( 2 FDA reports)
NERVE INJURY ( 2 FDA reports)
NEUTROPHIL COUNT INCREASED ( 2 FDA reports)
NO THERAPEUTIC RESPONSE ( 2 FDA reports)
ORAL HERPES ( 2 FDA reports)
ORTHOPEDIC PROCEDURE ( 2 FDA reports)
PARKINSON'S DISEASE ( 2 FDA reports)
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE ( 2 FDA reports)
PLATELET COUNT ABNORMAL ( 2 FDA reports)
PNEUMOTHORAX ( 2 FDA reports)
POLLAKIURIA ( 2 FDA reports)
POLYPOIDAL CHOROIDAL VASCULOPATHY ( 2 FDA reports)
POLYTRAUMATISM ( 2 FDA reports)
PRODUCT QUALITY ISSUE ( 2 FDA reports)
PROTHROMBIN TIME SHORTENED ( 2 FDA reports)
PULMONARY FUNCTION TEST DECREASED ( 2 FDA reports)
PULMONARY HAEMORRHAGE ( 2 FDA reports)
QRS AXIS ABNORMAL ( 2 FDA reports)
RADICULITIS LUMBOSACRAL ( 2 FDA reports)
RED BLOOD CELL SEDIMENTATION RATE INCREASED ( 2 FDA reports)
RENAL PAIN ( 2 FDA reports)
RENAL PAPILLARY NECROSIS ( 2 FDA reports)
RESPIRATORY ALKALOSIS ( 2 FDA reports)
RESPIRATORY ARREST ( 2 FDA reports)
RESPIRATORY TRACT INFECTION ( 2 FDA reports)
SCREAMING ( 2 FDA reports)
SKIN EXFOLIATION ( 2 FDA reports)
SUBDURAL HAEMORRHAGE ( 2 FDA reports)
THERAPEUTIC RESPONSE UNEXPECTED ( 2 FDA reports)
TOTAL LUNG CAPACITY DECREASED ( 2 FDA reports)
TOXIC ANTERIOR SEGMENT SYNDROME ( 2 FDA reports)
TRACHEITIS ( 2 FDA reports)
TRANSIENT ISCHAEMIC ATTACK ( 2 FDA reports)
TREMOR ( 2 FDA reports)
UPPER GASTROINTESTINAL HAEMORRHAGE ( 2 FDA reports)
URINARY INCONTINENCE ( 2 FDA reports)
URINARY RETENTION ( 2 FDA reports)
URINE OUTPUT DECREASED ( 2 FDA reports)
VERTIGO ( 2 FDA reports)
ABNORMAL BEHAVIOUR ( 1 FDA reports)
ACNE ( 1 FDA reports)
ACUTE PULMONARY OEDEMA ( 1 FDA reports)
ACUTE RESPIRATORY FAILURE ( 1 FDA reports)
AKATHISIA ( 1 FDA reports)
AMNESIA ( 1 FDA reports)
ANGER ( 1 FDA reports)
ANURIA ( 1 FDA reports)
AORTIC VALVE INCOMPETENCE ( 1 FDA reports)
APPENDICITIS ( 1 FDA reports)
ARTERIAL OCCLUSIVE DISEASE ( 1 FDA reports)
ASCITES ( 1 FDA reports)
ATRIAL THROMBOSIS ( 1 FDA reports)
BACTERIAL INFECTION ( 1 FDA reports)
BEDRIDDEN ( 1 FDA reports)
BLAST CRISIS IN MYELOGENOUS LEUKAEMIA ( 1 FDA reports)
BLOOD ELECTROLYTES DECREASED ( 1 FDA reports)
BLOOD IMMUNOGLOBULIN E INCREASED ( 1 FDA reports)
BLOOD LACTATE DEHYDROGENASE INCREASED ( 1 FDA reports)
BLOOD LACTIC ACID INCREASED ( 1 FDA reports)
BLOOD URINE PRESENT ( 1 FDA reports)
BONE DEBRIDEMENT ( 1 FDA reports)
BRADYARRHYTHMIA ( 1 FDA reports)
BRAIN INJURY ( 1 FDA reports)
BREAST PAIN ( 1 FDA reports)
BRONCHIAL INFECTION ( 1 FDA reports)
BRONCHIAL OBSTRUCTION ( 1 FDA reports)
BRONCHOPNEUMONIA ( 1 FDA reports)
CALCINOSIS ( 1 FDA reports)
CARDIAC AMYLOIDOSIS ( 1 FDA reports)
CARDIAC FAILURE ACUTE ( 1 FDA reports)
CARDIAC MURMUR ( 1 FDA reports)
CARDIAC OPERATION ( 1 FDA reports)
CARDIAC OUTPUT DECREASED ( 1 FDA reports)
CARDIOACTIVE DRUG LEVEL INCREASED ( 1 FDA reports)
CARDIOPULMONARY FAILURE ( 1 FDA reports)
CAROTID ARTERY DISEASE ( 1 FDA reports)
CATHETER RELATED INFECTION ( 1 FDA reports)
CEREBRAL HAEMATOMA ( 1 FDA reports)
CEREBRAL THROMBOSIS ( 1 FDA reports)
CEREBROVASCULAR DISORDER ( 1 FDA reports)
CHLOROMA ( 1 FDA reports)
CHOLECYSTITIS CHRONIC ( 1 FDA reports)
CHRONIC MYELOID LEUKAEMIA ( 1 FDA reports)
COAGULATION TIME SHORTENED ( 1 FDA reports)
COLITIS ( 1 FDA reports)
COLITIS ISCHAEMIC ( 1 FDA reports)
COMPLETED SUICIDE ( 1 FDA reports)
COMPLICATIONS OF TRANSPLANTED HEART ( 1 FDA reports)
CONCOMITANT DISEASE PROGRESSION ( 1 FDA reports)
CORONARY ANGIOPLASTY ( 1 FDA reports)
CORONARY ARTERY ATHEROSCLEROSIS ( 1 FDA reports)
CORONARY ARTERY BYPASS ( 1 FDA reports)
CULTURE WOUND POSITIVE ( 1 FDA reports)
DENTAL CARE ( 1 FDA reports)
DEPRESSED LEVEL OF CONSCIOUSNESS ( 1 FDA reports)
DEVICE RELATED INFECTION ( 1 FDA reports)
DIALYSIS ( 1 FDA reports)
DILATATION VENTRICULAR ( 1 FDA reports)
DISORIENTATION ( 1 FDA reports)
DISSEMINATED INTRAVASCULAR COAGULATION ( 1 FDA reports)
DIVERTICULUM INTESTINAL HAEMORRHAGIC ( 1 FDA reports)
DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS ( 1 FDA reports)
DYSGEUSIA ( 1 FDA reports)
EJECTION FRACTION ABNORMAL ( 1 FDA reports)
EJECTION FRACTION DECREASED ( 1 FDA reports)
ELECTROCARDIOGRAM QT PROLONGED ( 1 FDA reports)
ELECTROENCEPHALOGRAM ABNORMAL ( 1 FDA reports)
ENTEROBACTER INFECTION ( 1 FDA reports)
EOSINOPHIL COUNT INCREASED ( 1 FDA reports)
EYE INFLAMMATION ( 1 FDA reports)
EYE PAIN ( 1 FDA reports)
EYE SWELLING ( 1 FDA reports)
FACE INJURY ( 1 FDA reports)
FACIAL PAIN ( 1 FDA reports)
FEELING OF BODY TEMPERATURE CHANGE ( 1 FDA reports)
FEMUR FRACTURE ( 1 FDA reports)
FIBROADENOMA OF BREAST ( 1 FDA reports)
FLUID OVERLOAD ( 1 FDA reports)
FRUSTRATION ( 1 FDA reports)
GALLBLADDER DISORDER ( 1 FDA reports)
GALLBLADDER PERFORATION ( 1 FDA reports)
GASTROINTESTINAL OBSTRUCTION ( 1 FDA reports)
GENERALISED OEDEMA ( 1 FDA reports)
GENITAL HAEMORRHAGE ( 1 FDA reports)
GINGIVAL HYPERTROPHY ( 1 FDA reports)
GINGIVAL INFECTION ( 1 FDA reports)
GLUCOSE TOLERANCE IMPAIRED ( 1 FDA reports)
GLUCOSE URINE ( 1 FDA reports)
HAEMATOMA EVACUATION ( 1 FDA reports)
HAEMORRHAGIC ANAEMIA ( 1 FDA reports)
HAEMORRHAGIC DIATHESIS ( 1 FDA reports)
HAEMORRHAGIC STROKE ( 1 FDA reports)
HAIR GROWTH ABNORMAL ( 1 FDA reports)
HEART VALVE INCOMPETENCE ( 1 FDA reports)
HEPATIC CONGESTION ( 1 FDA reports)
HEPATIC FIBROSIS ( 1 FDA reports)
HEPATIC NECROSIS ( 1 FDA reports)
HEPATITIS C ( 1 FDA reports)
HEPATITIS TOXIC ( 1 FDA reports)
HERNIA ( 1 FDA reports)
HICCUPS ( 1 FDA reports)
HIGH DENSITY LIPOPROTEIN ( 1 FDA reports)
HIP SURGERY ( 1 FDA reports)
HIRSUTISM ( 1 FDA reports)
HOSPITALISATION ( 1 FDA reports)
HYPERLIPIDAEMIA ( 1 FDA reports)
HYPERTENSIVE HEART DISEASE ( 1 FDA reports)
ILLUSION ( 1 FDA reports)
IMPAIRED HEALING ( 1 FDA reports)
INCORRECT DOSE ADMINISTERED ( 1 FDA reports)
INCORRECT DRUG ADMINISTRATION DURATION ( 1 FDA reports)
INDURATION ( 1 FDA reports)
INJECTION SITE HAEMATOMA ( 1 FDA reports)
INTESTINAL PERFORATION ( 1 FDA reports)
INTRACRANIAL ANEURYSM ( 1 FDA reports)
INTRACRANIAL HYPOTENSION ( 1 FDA reports)
INTRACRANIAL VENOUS SINUS THROMBOSIS ( 1 FDA reports)
IRRITABILITY ( 1 FDA reports)
JOINT STIFFNESS ( 1 FDA reports)
KNEE ARTHROPLASTY ( 1 FDA reports)
LABORATORY TEST ABNORMAL ( 1 FDA reports)
LEUKOPENIA ( 1 FDA reports)
LIGAMENT SPRAIN ( 1 FDA reports)
LIVER SARCOIDOSIS ( 1 FDA reports)
LOW DENSITY LIPOPROTEIN ( 1 FDA reports)
LOW DENSITY LIPOPROTEIN INCREASED ( 1 FDA reports)
LUNG INFILTRATION ( 1 FDA reports)
MALARIA ( 1 FDA reports)
MALIGNANT MELANOMA ( 1 FDA reports)
MEDICAL DEVICE DISCOMFORT ( 1 FDA reports)
MEDICATION ERROR ( 1 FDA reports)
MEMORY IMPAIRMENT ( 1 FDA reports)
MENISCUS LESION ( 1 FDA reports)
MENOMETRORRHAGIA ( 1 FDA reports)
MENORRHAGIA ( 1 FDA reports)
MULTIPLE MYELOMA ( 1 FDA reports)
MYOGLOBIN BLOOD INCREASED ( 1 FDA reports)
MYOPATHY ( 1 FDA reports)
NAIL GROWTH ABNORMAL ( 1 FDA reports)
NASAL INFLAMMATION ( 1 FDA reports)
NECK INJURY ( 1 FDA reports)
NEPHROSCLEROSIS ( 1 FDA reports)
NERVOUS SYSTEM DISORDER ( 1 FDA reports)
NEUTROPENIA ( 1 FDA reports)
NIGHTMARE ( 1 FDA reports)
NO ADVERSE EVENT ( 1 FDA reports)
NOCTURIA ( 1 FDA reports)
NODAL RHYTHM ( 1 FDA reports)
NORMOCHROMIC NORMOCYTIC ANAEMIA ( 1 FDA reports)
OCULAR HYPERAEMIA ( 1 FDA reports)
ORAL INTAKE REDUCED ( 1 FDA reports)
ORAL SOFT TISSUE DISORDER ( 1 FDA reports)
ORTHOSTATIC HYPERTENSION ( 1 FDA reports)
ORTHOSTATIC HYPOTENSION ( 1 FDA reports)
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME ( 1 FDA reports)
PANCYTOPENIA ( 1 FDA reports)
PARANOIA ( 1 FDA reports)
PAROSMIA ( 1 FDA reports)
PARTIAL SEIZURES ( 1 FDA reports)
PERITONEAL HAEMORRHAGE ( 1 FDA reports)
PHARYNGEAL DISORDER ( 1 FDA reports)
PHARYNGEAL HAEMATOMA ( 1 FDA reports)
PITTING OEDEMA ( 1 FDA reports)
PLATELET COUNT DECREASED ( 1 FDA reports)
PLEURAL ADHESION ( 1 FDA reports)
PLEURISY ( 1 FDA reports)
POLYURIA ( 1 FDA reports)
POST PROCEDURAL COMPLICATION ( 1 FDA reports)
POST-TRAUMATIC STRESS DISORDER ( 1 FDA reports)
PROCALCITONIN INCREASED ( 1 FDA reports)
PROSTATE CANCER ( 1 FDA reports)
PROSTATE CANCER METASTATIC ( 1 FDA reports)
PROTEIN URINE PRESENT ( 1 FDA reports)
PSEUDOMONAL SEPSIS ( 1 FDA reports)
PSORIATIC ARTHROPATHY ( 1 FDA reports)
PSYCHOMOTOR HYPERACTIVITY ( 1 FDA reports)
PULMONARY ARTERIAL PRESSURE INCREASED ( 1 FDA reports)
PULMONARY CAVITATION ( 1 FDA reports)
PULMONARY CONGESTION ( 1 FDA reports)
PULMONARY FIBROSIS ( 1 FDA reports)
PULMONARY MASS ( 1 FDA reports)
PULMONARY SARCOIDOSIS ( 1 FDA reports)
RALES ( 1 FDA reports)
RECTAL HAEMORRHAGE ( 1 FDA reports)
RENAL ARTERY STENOSIS ( 1 FDA reports)
RIB FRACTURE ( 1 FDA reports)
RIGHT VENTRICULAR HYPERTROPHY ( 1 FDA reports)
ROTATOR CUFF SYNDROME ( 1 FDA reports)
SARCOIDOSIS ( 1 FDA reports)
SCAB ( 1 FDA reports)
SENSATION OF HEAVINESS ( 1 FDA reports)
SIMPLE PARTIAL SEIZURES ( 1 FDA reports)
SINUS CONGESTION ( 1 FDA reports)
SKIN HYPERPIGMENTATION ( 1 FDA reports)
SPLENOMEGALY ( 1 FDA reports)
STAPHYLOCOCCAL BACTERAEMIA ( 1 FDA reports)
STAPHYLOCOCCAL SEPSIS ( 1 FDA reports)
SUBDURAL HAEMATOMA ( 1 FDA reports)
SUBRETINAL FIBROSIS ( 1 FDA reports)
SUDDEN DEATH ( 1 FDA reports)
SUICIDAL BEHAVIOUR ( 1 FDA reports)
SUICIDAL IDEATION ( 1 FDA reports)
SWELLING ( 1 FDA reports)
THERAPEUTIC AGENT TOXICITY ( 1 FDA reports)
THIRST ( 1 FDA reports)
THROMBOCYTHAEMIA ( 1 FDA reports)
THROMBOPHLEBITIS SEPTIC ( 1 FDA reports)
TONIC CONVULSION ( 1 FDA reports)
TOOTH INFECTION ( 1 FDA reports)
TOXICITY TO VARIOUS AGENTS ( 1 FDA reports)
TRACHEAL STENOSIS ( 1 FDA reports)
TREATMENT NONCOMPLIANCE ( 1 FDA reports)
TROPONIN INCREASED ( 1 FDA reports)
TUMOUR EXCISION ( 1 FDA reports)
TUMOUR NECROSIS ( 1 FDA reports)
UNRESPONSIVE TO STIMULI ( 1 FDA reports)
VAGINITIS BACTERIAL ( 1 FDA reports)
VENA CAVA THROMBOSIS ( 1 FDA reports)
VENTRICULAR DYSFUNCTION ( 1 FDA reports)
X-RAY ABNORMAL ( 1 FDA reports)

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