Drug information for RAPAFLO

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE; ORAL 4MG Prescription   SILODOSIN KMD 3213 WATSON LABS 22206
2010-03-08 Letter
2010-03-05 Label
2009-02-20 Label
2009-02-18 Letter
2008-11-17 Summary Review
2008-11-14 Review
2008-11-07 Label
2008-10-14 Letter
CAPSULE; ORAL 8MG Prescription  (Reference Drug) SILODOSIN KMD 3213 WATSON LABS   "

Drug Adverse Effects information for RAPAFLO

Role code Indications Reaction # Reports
PS ANAEMIA LIVER DISORDER 1
PS BENIGN PROSTATIC HYPERPLASIA ARRHYTHMIA 2
PS BENIGN PROSTATIC HYPERPLASIA CEREBRAL INFARCTION 2
PS BENIGN PROSTATIC HYPERPLASIA LIVER DISORDER 2
PS BENIGN PROSTATIC HYPERPLASIA LOSS OF CONSCIOUSNESS 1
PS BENIGN PROSTATIC HYPERPLASIA METASTATIC NEOPLASM 1
PS BENIGN PROSTATIC HYPERPLASIA RASH ERYTHEMATOUS 1
PS BENIGN PROSTATIC HYPERPLASIA TOXIC SKIN ERUPTION 1
PS BLADDER OBSTRUCTION ARRHYTHMIA 1
PS BLADDER OBSTRUCTION DIZZINESS 1
PS BRONCHITIS DECREASED APPETITE 1
PS BRONCHITIS DRY MOUTH 1
PS BRONCHITIS DYSGEUSIA 1
PS BRONCHITIS INSOMNIA 1
PS BRONCHITIS POLYDIPSIA 1
PS BRONCHITIS POLYURIA 1
PS BRONCHITIS WEIGHT DECREASED 1
PS CORONARY ARTERY DISEASE ARRHYTHMIA 1
PS CORONARY ARTERY DISEASE DIZZINESS 1
PS DYSTHYMIC DISORDER LIVER DISORDER 1
PS DYSURIA FEMUR FRACTURE 1
PS DYSURIA LIVER DISORDER 3
PS DYSURIA LOSS OF CONSCIOUSNESS 4
PS DYSURIA PNEUMONIA 1
PS DYSURIA PNEUMONIA ASPIRATION 2
PS DYSURIA RENAL FAILURE CHRONIC 2
PS DYSURIA WHITE BLOOD CELL COUNT DECREASED 3
PS EPILEPSY PNEUMONIA ASPIRATION 1
PS EPILEPSY WHITE BLOOD CELL COUNT DECREASED 1
PS GASTRIC CANCER RENAL FAILURE CHRONIC 5
PS GASTRIC ULCER LIVER DISORDER 5
PS GASTRIC ULCER HAEMORRHAGE LIVER DISORDER 5
PS GASTROOESOPHAGEAL REFLUX DISEASE LIVER DISORDER 1
PS HYPERTENSION ABDOMINAL DISCOMFORT 3
PS HYPERTENSION ANGINA PECTORIS 3
PS HYPERTENSION CARDIAC FAILURE 3
PS HYPERTENSION PAIN IN EXTREMITY 3
PS HYPERTENSION RESTLESSNESS 3
PS NUTRITIONAL SUPPORT LIVER DISORDER 1
PS PAIN TACHYCARDIA 2
PS PRODUCT USED FOR UNKNOWN INDICATION ARRHYTHMIA 6
PS PRODUCT USED FOR UNKNOWN INDICATION CEREBRAL INFARCTION 6
PS PRODUCT USED FOR UNKNOWN INDICATION DEATH 10
PS PRODUCT USED FOR UNKNOWN INDICATION DECREASED APPETITE 6
PS PRODUCT USED FOR UNKNOWN INDICATION DRY MOUTH 6
PS PRODUCT USED FOR UNKNOWN INDICATION DYSGEUSIA 6
PS PRODUCT USED FOR UNKNOWN INDICATION INSOMNIA 6
PS PRODUCT USED FOR UNKNOWN INDICATION LIVER DISORDER 6
PS PRODUCT USED FOR UNKNOWN INDICATION LOSS OF CONSCIOUSNESS 24
PS PRODUCT USED FOR UNKNOWN INDICATION PNEUMONIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION PNEUMONIA ASPIRATION 7
PS PRODUCT USED FOR UNKNOWN INDICATION POLYDIPSIA 6
PS PRODUCT USED FOR UNKNOWN INDICATION POLYURIA 6
PS PRODUCT USED FOR UNKNOWN INDICATION RASH ERYTHEMATOUS 1
PS PRODUCT USED FOR UNKNOWN INDICATION SYNCOPE 2
PS PRODUCT USED FOR UNKNOWN INDICATION TACHYCARDIA 2
PS PRODUCT USED FOR UNKNOWN INDICATION TOXIC SKIN ERUPTION 1
PS PRODUCT USED FOR UNKNOWN INDICATION WEIGHT DECREASED 6
PS PRODUCT USED FOR UNKNOWN INDICATION WHITE BLOOD CELL COUNT DECREASED 8
PS PROPHYLAXIS TACHYCARDIA 1
PS PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER RENAL FAILURE CHRONIC 1
PS PROSTATIC DISORDER ATRIAL FLUTTER 1
PS PROSTATIC DISORDER DRY MOUTH 1
PS PROSTATIC DISORDER EJACULATION FAILURE 1
PS PROSTATIC DISORDER NASAL CONGESTION 1
PS PROSTATIC DISORDER NAUSEA 1
PS PROSTATIC DISORDER VOMITING 1
PS PROSTATITIS TACHYCARDIA 1
PS PROSTATOMEGALY ABDOMINAL DISCOMFORT 1
PS PROSTATOMEGALY ANGINA PECTORIS 1
PS PROSTATOMEGALY CARDIAC FAILURE 1
PS PROSTATOMEGALY PAIN IN EXTREMITY 1
PS PROSTATOMEGALY RESTLESSNESS 1
PS PYREXIA PNEUMONIA ASPIRATION 1
PS PYREXIA WHITE BLOOD CELL COUNT DECREASED 1
PS ROUTINE HEALTH MAINTENANCE ABDOMINAL DISCOMFORT 1
PS ROUTINE HEALTH MAINTENANCE ANGINA PECTORIS 1
PS ROUTINE HEALTH MAINTENANCE CARDIAC FAILURE 1
PS ROUTINE HEALTH MAINTENANCE PAIN IN EXTREMITY 1
PS ROUTINE HEALTH MAINTENANCE RESTLESSNESS 1
PS SWELLING NAUSEA 1
PS SWELLING VOMITING 1
PS URINARY INCONTINENCE ABDOMINAL DISCOMFORT 1
PS URINARY INCONTINENCE ANGINA PECTORIS 1
PS URINARY INCONTINENCE CARDIAC FAILURE 1
PS URINARY INCONTINENCE PAIN IN EXTREMITY 1
PS URINARY INCONTINENCE RESTLESSNESS 1
PS URINARY TRACT OBSTRUCTION ARRHYTHMIA 1
PS URINARY TRACT OBSTRUCTION DIZZINESS 1
SS BENIGN PROSTATIC HYPERPLASIA PRURITUS 1
SS DYSURIA LOSS OF CONSCIOUSNESS 2
SS HYPERTENSION ABDOMINAL DISCOMFORT 3
SS HYPERTENSION ANGINA PECTORIS 3
SS HYPERTENSION CARDIAC FAILURE 3
SS HYPERTENSION PAIN IN EXTREMITY 3
SS HYPERTENSION RESTLESSNESS 3
SS PRODUCT USED FOR UNKNOWN INDICATION LOSS OF CONSCIOUSNESS 21
SS PROSTATIC DISORDER ABDOMINAL PAIN 1
SS PROSTATIC DISORDER WEIGHT INCREASED 1
SS PROSTATITIS ARRHYTHMIA SUPRAVENTRICULAR 2
SS PROSTATITIS FEELING ABNORMAL 2
SS PROSTATOMEGALY ABDOMINAL DISCOMFORT 1
SS PROSTATOMEGALY ANGINA PECTORIS 1
SS PROSTATOMEGALY CARDIAC FAILURE 1
SS PROSTATOMEGALY PAIN IN EXTREMITY 1
SS PROSTATOMEGALY RESTLESSNESS 1
SS ROUTINE HEALTH MAINTENANCE ABDOMINAL DISCOMFORT 1
SS ROUTINE HEALTH MAINTENANCE ANGINA PECTORIS 1
SS ROUTINE HEALTH MAINTENANCE CARDIAC FAILURE 1
SS ROUTINE HEALTH MAINTENANCE PAIN IN EXTREMITY 1
SS ROUTINE HEALTH MAINTENANCE RESTLESSNESS 1
SS SMOKING CESSATION THERAPY ABDOMINAL PAIN 1
SS SMOKING CESSATION THERAPY WEIGHT INCREASED 1
SS URINARY INCONTINENCE ABDOMINAL DISCOMFORT 1
SS URINARY INCONTINENCE ANGINA PECTORIS 1
SS URINARY INCONTINENCE CARDIAC FAILURE 1
SS URINARY INCONTINENCE PAIN IN EXTREMITY 1
SS URINARY INCONTINENCE RESTLESSNESS 1
C ANAEMIA INTERVERTEBRAL DISC PROTRUSION 1
C ANAEMIA OFF LABEL USE 1
C ANAEMIA POST PROCEDURAL HAEMORRHAGE 1
C ARRHYTHMIA CONTUSION 1
C ARRHYTHMIA DIZZINESS 1
C ARRHYTHMIA HYPOTENSION 1
C ARRHYTHMIA INTERVERTEBRAL DISC PROTRUSION 1
C ARRHYTHMIA OFF LABEL USE 1
C ARRHYTHMIA POST PROCEDURAL HAEMORRHAGE 1
C ATRIAL FIBRILLATION CEREBRAL HAEMORRHAGE 1
C BACK PAIN AGITATION 2
C BACK PAIN ARTERIAL THROMBOSIS LIMB 2
C BACK PAIN DRUG INEFFECTIVE 2
C BACK PAIN ONYCHOMADESIS 2
C BACK PAIN SKIN DISCOLOURATION 2
C BENIGN PROSTATIC HYPERPLASIA EJACULATION FAILURE 1
C DEPRESSION INTERVERTEBRAL DISC PROTRUSION 1
C DEPRESSION OFF LABEL USE 1
C DEPRESSION POST PROCEDURAL HAEMORRHAGE 1
C DYSURIA INTERVERTEBRAL DISC PROTRUSION 1
C DYSURIA OFF LABEL USE 1
C DYSURIA POST PROCEDURAL HAEMORRHAGE 1
C GASTRIC DISORDER AGITATION 2
C GASTRIC DISORDER ARTERIAL THROMBOSIS LIMB 2
C GASTRIC DISORDER DRUG INEFFECTIVE 2
C GASTRIC DISORDER ONYCHOMADESIS 2
C GASTRIC DISORDER SKIN DISCOLOURATION 2
C MULTIPLE SCLEROSIS ASTHENIA 2
C MULTIPLE SCLEROSIS BACK PAIN 2
C MULTIPLE SCLEROSIS FATIGUE 2
C MULTIPLE SCLEROSIS LIVER FUNCTION TEST ABNORMAL 2
C MULTIPLE SCLEROSIS MULTIPLE SCLEROSIS RELAPSE 2
C OSTEOPOROSIS BALANCE DISORDER 1
C OSTEOPOROSIS CARDIAC FAILURE 1
C OSTEOPOROSIS CHROMATURIA 1
C OSTEOPOROSIS CONTUSION 1
C OSTEOPOROSIS DECREASED APPETITE 1
C OSTEOPOROSIS DEHYDRATION 1
C OSTEOPOROSIS DIZZINESS 1
C OSTEOPOROSIS DYSPHAGIA 1
C OSTEOPOROSIS DYSPNOEA 1
C OSTEOPOROSIS FALL 1
C OSTEOPOROSIS FLUID RETENTION 1
C OSTEOPOROSIS HEAD INJURY 1
C OSTEOPOROSIS HEART RATE DECREASED 1
C OSTEOPOROSIS HEART RATE INCREASED 1
C OSTEOPOROSIS HYPOTENSION 2
C OSTEOPOROSIS LACERATION 1
C OSTEOPOROSIS MALAISE 1
C OSTEOPOROSIS MOVEMENT DISORDER 1
C OSTEOPOROSIS MUSCLE DISORDER 1
C OSTEOPOROSIS PNEUMONIA 1
C OSTEOPOROSIS PNEUMONIA ASPIRATION 1
C OSTEOPOROSIS SKIN WRINKLING 1
C OSTEOPOROSIS TRAUMATIC INTRACRANIAL HAEMORRHAGE 1
C OSTEOPOROSIS WEIGHT DECREASED 1
C PAIN INTERVERTEBRAL DISC PROTRUSION 1
C PAIN OFF LABEL USE 1
C PAIN POST PROCEDURAL HAEMORRHAGE 1
C POST-TRAUMATIC STRESS DISORDER INTERVERTEBRAL DISC PROTRUSION 1
C POST-TRAUMATIC STRESS DISORDER OFF LABEL USE 1
C POST-TRAUMATIC STRESS DISORDER POST PROCEDURAL HAEMORRHAGE 1
C PRODUCT USED FOR UNKNOWN INDICATION ATRIAL FIBRILLATION 5
C PRODUCT USED FOR UNKNOWN INDICATION CHEST PAIN 5
C PRODUCT USED FOR UNKNOWN INDICATION DRUG INEFFECTIVE 2
C PRODUCT USED FOR UNKNOWN INDICATION MYOCARDIAL INFARCTION 5
C PRODUCT USED FOR UNKNOWN INDICATION SEPSIS 5
C PRODUCT USED FOR UNKNOWN INDICATION THROMBOSIS 5
C RHEUMATOID ARTHRITIS ATRIAL FIBRILLATION 1
C RHEUMATOID ARTHRITIS CHEST PAIN 1
C RHEUMATOID ARTHRITIS MYOCARDIAL INFARCTION 1
C RHEUMATOID ARTHRITIS SEPSIS 1
C RHEUMATOID ARTHRITIS THROMBOSIS 1
C SLEEP DISORDER INTERVERTEBRAL DISC PROTRUSION 1
C SLEEP DISORDER OFF LABEL USE 1
C SLEEP DISORDER POST PROCEDURAL HAEMORRHAGE 1
C SUPPLEMENTATION THERAPY ATRIAL FIBRILLATION 1
C SUPPLEMENTATION THERAPY CHEST PAIN 1
C SUPPLEMENTATION THERAPY MYOCARDIAL INFARCTION 1
C SUPPLEMENTATION THERAPY SEPSIS 1
C SUPPLEMENTATION THERAPY THROMBOSIS 1
C URINARY TRACT INFECTION BALANCE DISORDER 1
C URINARY TRACT INFECTION MOBILITY DECREASED 1
C URINARY TRACT INFECTION TENDON RUPTURE 1
C URINE ABNORMALITY AGITATION 1
C URINE ABNORMALITY ARTERIAL THROMBOSIS LIMB 1
C URINE ABNORMALITY DRUG INEFFECTIVE 1
C URINE ABNORMALITY ONYCHOMADESIS 1
C URINE ABNORMALITY SKIN DISCOLOURATION 1
C VITAMIN SUPPLEMENTATION ATRIAL FIBRILLATION 1
C VITAMIN SUPPLEMENTATION CHEST PAIN 1
C VITAMIN SUPPLEMENTATION MYOCARDIAL INFARCTION 1
C VITAMIN SUPPLEMENTATION SEPSIS 1
C VITAMIN SUPPLEMENTATION THROMBOSIS 1
I BENIGN PROSTATIC HYPERPLASIA DRUG INTERACTION 2
I BENIGN PROSTATIC HYPERPLASIA DYSPNOEA 2
I LYME DISEASE DRUG INTERACTION 4
I LYME DISEASE DYSPNOEA 4
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