Drug information for SECTRAL

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE; ORAL EQ 200MG BASE Prescription AB  ACEBUTOLOL HYDROCHLORIDE Acebutolol PROMIUS PHARMA 18917
2011-03-07 Letter

2007-09-11 Label

2007-09-11 Letter
CAPSULE; ORAL EQ 400MG BASE Prescription AB (Reference Drug) ACEBUTOLOL HYDROCHLORIDE Acebutolol PROMIUS PHARMA   "

Drug Adverse Effects information for SECTRAL

Role code Indications Reaction # Reports
PS CARDIAC FAILURE CONGESTIVE HYPOTHYROIDISM 1
SS ATRIAL FIBRILLATION BRADYCARDIA 2
SS ATRIAL FIBRILLATION COGNITIVE DISORDER 2
SS ATRIAL FIBRILLATION HYPERKALAEMIA 2
SS ATRIAL FIBRILLATION HYPONATRAEMIA 2
SS ATRIAL FIBRILLATION MALAISE 2
SS CARDIAC FAILURE CONFUSIONAL STATE 4
SS CARDIAC FAILURE DEHYDRATION 4
SS CARDIAC FAILURE DIARRHOEA 2
SS CARDIAC FAILURE ELECTROCARDIOGRAM QRS COMPLEX PROLONGED 4
SS CARDIAC FAILURE HYPERKALAEMIA 4
SS CARDIAC FAILURE LACTIC ACIDOSIS 4
SS CARDIAC FAILURE RENAL FAILURE ACUTE 4
SS HYPERTENSION CONFUSIONAL STATE 8
SS HYPERTENSION DEHYDRATION 8
SS HYPERTENSION DIARRHOEA 4
SS HYPERTENSION ELECTROCARDIOGRAM QRS COMPLEX PROLONGED 8
SS HYPERTENSION HYPERKALAEMIA 8
SS HYPERTENSION LACTIC ACIDOSIS 8
SS HYPERTENSION RENAL FAILURE ACUTE 8
SS MYOCARDIAL ISCHAEMIA BRADYCARDIA 2
SS MYOCARDIAL ISCHAEMIA COGNITIVE DISORDER 2
SS MYOCARDIAL ISCHAEMIA HYPERKALAEMIA 2
SS MYOCARDIAL ISCHAEMIA HYPONATRAEMIA 2
SS MYOCARDIAL ISCHAEMIA MALAISE 2
SS PLEUROPERICARDITIS AGITATION 4
SS PLEUROPERICARDITIS ARRHYTHMIA 2
SS PLEUROPERICARDITIS CONFUSIONAL STATE 4
SS PLEUROPERICARDITIS DYSKINESIA 4
SS PLEUROPERICARDITIS SUDDEN DEATH 2
SS PRODUCT USED FOR UNKNOWN INDICATION AGITATION 16
SS PRODUCT USED FOR UNKNOWN INDICATION ARRHYTHMIA 8
SS PRODUCT USED FOR UNKNOWN INDICATION CONFUSIONAL STATE 16
SS PRODUCT USED FOR UNKNOWN INDICATION DYSKINESIA 16
SS PRODUCT USED FOR UNKNOWN INDICATION SUDDEN DEATH 8
SS TYPE 2 DIABETES MELLITUS CONFUSIONAL STATE 4
SS TYPE 2 DIABETES MELLITUS DEHYDRATION 4
SS TYPE 2 DIABETES MELLITUS DIARRHOEA 2
SS TYPE 2 DIABETES MELLITUS ELECTROCARDIOGRAM QRS COMPLEX PROLONGED 4
SS TYPE 2 DIABETES MELLITUS HYPERKALAEMIA 4
SS TYPE 2 DIABETES MELLITUS LACTIC ACIDOSIS 4
SS TYPE 2 DIABETES MELLITUS RENAL FAILURE ACUTE 4
C ABDOMINAL PAIN ANAEMIA 2
C ABDOMINAL PAIN COLITIS ULCERATIVE 2
C ABDOMINAL PAIN CYTOMEGALOVIRUS INFECTION 2
C ABDOMINAL PAIN WEIGHT DECREASED 2
C AGITATION PNEUMONIA 2
C AGITATION SEPTIC SHOCK 2
C AGITATION TOXIC EPIDERMAL NECROLYSIS 2
C ANTIBIOTIC THERAPY ANAEMIA 2
C ANTIBIOTIC THERAPY COLITIS ULCERATIVE 2
C ANTIBIOTIC THERAPY CYTOMEGALOVIRUS INFECTION 2
C ANTIBIOTIC THERAPY WEIGHT DECREASED 2
C ASCITES CHROMATURIA 2
C ASCITES EPISTAXIS 2
C ASCITES GINGIVAL BLEEDING 2
C ASCITES IDIOPATHIC THROMBOCYTOPENIC PURPURA 2
C ASCITES RENAL FAILURE ACUTE 2
C ASCITES THROMBOCYTOPENIA 2
C BLOOD CHOLESTEROL DRUG INEFFECTIVE 1
C BLOOD CHOLESTEROL TRANSPLANT FAILURE 1
C BLOOD PRESSURE DRUG INEFFECTIVE 1
C BLOOD PRESSURE TRANSPLANT FAILURE 1
C BRONCHITIS FACE OEDEMA 1
C BRONCHITIS URTICARIA 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE FACE OEDEMA 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE URTICARIA 1
C COLITIS ULCERATIVE ANAEMIA 6
C COLITIS ULCERATIVE COLITIS ULCERATIVE 6
C COLITIS ULCERATIVE CYTOMEGALOVIRUS INFECTION 6
C COLITIS ULCERATIVE WEIGHT DECREASED 6
C COLORECTAL CANCER ABNORMAL BEHAVIOUR 1
C COLORECTAL CANCER AGGRESSION 1
C COLORECTAL CANCER ANXIETY 1
C COLORECTAL CANCER APATHY 1
C COLORECTAL CANCER COGNITIVE DISORDER 1
C COLORECTAL CANCER DISINHIBITION 1
C COLORECTAL CANCER EXCESSIVE MASTURBATION 1
C COLORECTAL CANCER LIBIDO INCREASED 1
C COLORECTAL CANCER ORTHOSTATIC HYPOTENSION 1
C COLORECTAL CANCER PSYCHOSEXUAL DISORDER 1
C COLORECTAL CANCER SLEEP DISORDER 1
C COLORECTAL CANCER SOCIAL AVOIDANT BEHAVIOUR 1
C COLORECTAL CANCER VITAMIN D DECREASED 1
C COLORECTAL CANCER METASTATIC ATRIAL TACHYCARDIA 6
C CYTOMEGALOVIRUS INFECTION ANAEMIA 2
C CYTOMEGALOVIRUS INFECTION COLITIS ULCERATIVE 2
C CYTOMEGALOVIRUS INFECTION CYTOMEGALOVIRUS INFECTION 2
C CYTOMEGALOVIRUS INFECTION WEIGHT DECREASED 2
C DEMENTIA AGGRESSION 1
C DEMENTIA AGITATION 1
C DEMENTIA CONFUSIONAL STATE 1
C DEMENTIA SUICIDE ATTEMPT 1
C DEPRESSION ANAEMIA 2
C DEPRESSION COLITIS ULCERATIVE 2
C DEPRESSION CYTOMEGALOVIRUS INFECTION 2
C DEPRESSION GENERAL PHYSICAL HEALTH DETERIORATION 4
C DEPRESSION PNEUMONIA 1
C DEPRESSION SEPTIC SHOCK 1
C DEPRESSION TOXIC ENCEPHALOPATHY 5
C DEPRESSION TOXIC EPIDERMAL NECROLYSIS 1
C DEPRESSION WEIGHT DECREASED 2
C DYSLIPIDAEMIA HYPOKALAEMIA 1
C DYSLIPIDAEMIA RENAL FAILURE ACUTE 1
C DYSLIPIDAEMIA RHABDOMYOLYSIS 1
C EPILEPSY PNEUMONIA 1
C EPILEPSY SEPTIC SHOCK 1
C EPILEPSY TOXIC EPIDERMAL NECROLYSIS 1
C GASTROOESOPHAGEAL REFLUX DISEASE HYPERSOMNIA 1
C HEPATITIS C DYSPNOEA 3
C HEPATITIS C PALPITATIONS 3
C HEPATITIS C TACHYCARDIA 3
C HEPATITIS C VENTRICULAR EXTRASYSTOLES 3
C HEPATITIS C VENTRICULAR TACHYCARDIA 3
C HERPES OPHTHALMIC DRUG INEFFECTIVE 1
C HERPES OPHTHALMIC TRANSPLANT FAILURE 1
C HYPERCHOLESTEROLAEMIA ANAEMIA 2
C HYPERCHOLESTEROLAEMIA COLITIS ULCERATIVE 2
C HYPERCHOLESTEROLAEMIA CYTOMEGALOVIRUS INFECTION 2
C HYPERCHOLESTEROLAEMIA WEIGHT DECREASED 2
C HYPERTENSION AGGRESSION 2
C HYPERTENSION AGITATION 2
C HYPERTENSION ALPHA 1 MICROGLOBULIN INCREASED 1
C HYPERTENSION ANAEMIA 2
C HYPERTENSION CHROMATURIA 2
C HYPERTENSION COLITIS ULCERATIVE 2
C HYPERTENSION CONFUSIONAL STATE 2
C HYPERTENSION CYTOMEGALOVIRUS INFECTION 2
C HYPERTENSION EPISTAXIS 2
C HYPERTENSION FACE OEDEMA 1
C HYPERTENSION GENERAL PHYSICAL HEALTH DETERIORATION 4
C HYPERTENSION GINGIVAL BLEEDING 2
C HYPERTENSION HYPERSOMNIA 3
C HYPERTENSION IDIOPATHIC THROMBOCYTOPENIC PURPURA 2
C HYPERTENSION METASTATIC MALIGNANT MELANOMA 4
C HYPERTENSION RENAL FAILURE ACUTE 2
C HYPERTENSION RENAL TUBULAR DISORDER 1
C HYPERTENSION SUICIDE ATTEMPT 2
C HYPERTENSION THROMBOCYTOPENIA 2
C HYPERTENSION TOXIC ENCEPHALOPATHY 5
C HYPERTENSION URTICARIA 1
C HYPERTENSION WEIGHT DECREASED 2
C HYPERURICAEMIA METASTATIC MALIGNANT MELANOMA 2
C HYPOTHYROIDISM HYPERSOMNIA 1
C INFECTION PROPHYLAXIS PNEUMONIA 1
C INFECTION PROPHYLAXIS SEPTIC SHOCK 1
C INFECTION PROPHYLAXIS TOXIC EPIDERMAL NECROLYSIS 1
C ISCHAEMIC HEART DISEASE PROPHYLAXIS ANAEMIA 2
C ISCHAEMIC HEART DISEASE PROPHYLAXIS COLITIS ULCERATIVE 2
C ISCHAEMIC HEART DISEASE PROPHYLAXIS CYTOMEGALOVIRUS INFECTION 2
C ISCHAEMIC HEART DISEASE PROPHYLAXIS WEIGHT DECREASED 2
C LUNG DISORDER AKATHISIA 1
C LUNG DISORDER CONFUSIONAL STATE 1
C LUNG DISORDER CYTOLYTIC HEPATITIS 1
C LUNG DISORDER DECREASED APPETITE 1
C LUNG DISORDER DEHYDRATION 1
C LUNG DISORDER FACE OEDEMA 1
C LUNG DISORDER HYPERNATRAEMIA 1
C LUNG DISORDER THROMBOCYTOPENIA 1
C LUNG DISORDER URTICARIA 1
C METASTASES TO KIDNEY CHEST DISCOMFORT 1
C METASTASES TO KIDNEY COUGH 1
C METASTASES TO KIDNEY DYSPNOEA 1
C METASTASES TO KIDNEY FATIGUE 1
C METASTASES TO KIDNEY FIBRIN D DIMER INCREASED 1
C METASTASES TO KIDNEY HYPOCAPNIA 1
C METASTASES TO KIDNEY HYPOXIA 1
C METASTASES TO KIDNEY INTERSTITIAL LUNG DISEASE 1
C METASTASES TO KIDNEY LUNG INFILTRATION 1
C METASTASES TO KIDNEY MALAISE 1
C METASTASES TO KIDNEY PLEURAL DISORDER 1
C METASTASES TO KIDNEY PLEURAL EFFUSION 1
C METASTASES TO KIDNEY PULMONARY EMBOLISM 1
C METASTASES TO KIDNEY RESPIRATORY RATE INCREASED 1
C METASTASES TO KIDNEY RESTRICTIVE PULMONARY DISEASE 1
C MULTIPLE MYELOMA AREFLEXIA 3
C MULTIPLE MYELOMA ASTHENIA 3
C MULTIPLE MYELOMA CONFUSIONAL STATE 3
C MULTIPLE MYELOMA DISORIENTATION 3
C MULTIPLE MYELOMA ENCEPHALOPATHY 9
C MULTIPLE MYELOMA EXTENSOR PLANTAR RESPONSE 3
C MULTIPLE MYELOMA EXTRAPYRAMIDAL DISORDER 9
C MULTIPLE MYELOMA GENERAL PHYSICAL HEALTH DETERIORATION 12
C MULTIPLE MYELOMA TOXIC ENCEPHALOPATHY 21
C NARCOLEPSY CARDIAC NEOPLASM UNSPECIFIED 1
C NARCOLEPSY HEADACHE 1
C PAIN AGITATION 1
C PAIN AREFLEXIA 2
C PAIN ASTHENIA 2
C PAIN CIRCADIAN RHYTHM SLEEP DISORDER 1
C PAIN CONFUSIONAL STATE 5
C PAIN DISORIENTATION 4
C PAIN ENCEPHALOPATHY 11
C PAIN EXTENSOR PLANTAR RESPONSE 2
C PAIN EXTRAPYRAMIDAL DISORDER 11
C PAIN FALL 1
C PAIN GENERAL PHYSICAL HEALTH DETERIORATION 4
C PAIN HALLUCINATION 1
C PAIN HALLUCINATION, VISUAL 2
C PAIN TOXIC ENCEPHALOPATHY 5
C PNEUMONIA ABNORMAL BEHAVIOUR 2
C PNEUMONIA ATRIAL FIBRILLATION 2
C PNEUMONIA CONFUSIONAL STATE 2
C PNEUMONIA CYTOLYTIC HEPATITIS 2
C PNEUMONIA DECREASED APPETITE 2
C PNEUMONIA DEHYDRATION 2
C PNEUMONIA DELIRIUM 2
C PNEUMONIA DIET REFUSAL 2
C PNEUMONIA HYPERNATRAEMIA 2
C PNEUMONIA LEUKOCYTOSIS 2
C PNEUMONIA PNEUMONIA 3
C PNEUMONIA PRODUCTIVE COUGH 2
C PNEUMONIA PSYCHOMOTOR HYPERACTIVITY 2
C PNEUMONIA PULMONARY EMBOLISM 2
C PNEUMONIA SEPTIC SHOCK 1
C PNEUMONIA THROMBOCYTOPENIA 2
C PNEUMONIA TOXIC EPIDERMAL NECROLYSIS 1
C PRODUCT USED FOR UNKNOWN INDICATION AGITATION 12
C PRODUCT USED FOR UNKNOWN INDICATION AKATHISIA 7
C PRODUCT USED FOR UNKNOWN INDICATION AREFLEXIA 1
C PRODUCT USED FOR UNKNOWN INDICATION ASTHENIA 1
C PRODUCT USED FOR UNKNOWN INDICATION CIRCADIAN RHYTHM SLEEP DISORDER 12
C PRODUCT USED FOR UNKNOWN INDICATION CONFUSIONAL STATE 20
C PRODUCT USED FOR UNKNOWN INDICATION CYTOLYTIC HEPATITIS 7
C PRODUCT USED FOR UNKNOWN INDICATION DECREASED APPETITE 7
C PRODUCT USED FOR UNKNOWN INDICATION DEHYDRATION 7
C PRODUCT USED FOR UNKNOWN INDICATION DISORIENTATION 1
C PRODUCT USED FOR UNKNOWN INDICATION DRUG INEFFECTIVE 1
C PRODUCT USED FOR UNKNOWN INDICATION DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS 6
C PRODUCT USED FOR UNKNOWN INDICATION ENCEPHALOPATHY 4
C PRODUCT USED FOR UNKNOWN INDICATION EXTENSOR PLANTAR RESPONSE 1
C PRODUCT USED FOR UNKNOWN INDICATION EXTRAPYRAMIDAL DISORDER 4
C PRODUCT USED FOR UNKNOWN INDICATION FACE OEDEMA 1
C PRODUCT USED FOR UNKNOWN INDICATION FALL 12
C PRODUCT USED FOR UNKNOWN INDICATION HALLUCINATION 12
C PRODUCT USED FOR UNKNOWN INDICATION HYPERNATRAEMIA 7
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE ERYTHEMA 1
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE PAIN 1
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE SWELLING 1
C PRODUCT USED FOR UNKNOWN INDICATION LYMPHOID TISSUE HYPERPLASIA 4
C PRODUCT USED FOR UNKNOWN INDICATION THROMBOCYTOPENIA 7
C PRODUCT USED FOR UNKNOWN INDICATION TRANSPLANT FAILURE 1
C PRODUCT USED FOR UNKNOWN INDICATION URTICARIA 1
C PSYCHOTIC DISORDER PNEUMONIA 1
C PSYCHOTIC DISORDER SEPTIC SHOCK 1
C PSYCHOTIC DISORDER TOXIC EPIDERMAL NECROLYSIS 1
C RENAL TRANSPLANT HYPERCREATININAEMIA 3
C RENAL TRANSPLANT IMMUNOSUPPRESSANT DRUG LEVEL DECREASED 3
C RENAL TRANSPLANT OVERDOSE 3
C RENAL TRANSPLANT PNEUMONIA LEGIONELLA 1
C RENAL TRANSPLANT POSTRENAL FAILURE 4
C RENAL TRANSPLANT RENAL FAILURE 3
C RENAL TRANSPLANT RENAL FAILURE ACUTE 1
C RENAL TRANSPLANT RENAL IMPAIRMENT 3
C RENAL TRANSPLANT RENAL TUBULAR NECROSIS 1
C RENAL TRANSPLANT SEPSIS 1
C RENAL TRANSPLANT URINARY TRACT INFECTION 4
C RENAL TRANSPLANT URINE OUTPUT DECREASED 3
C RHEUMATOID ARTHRITIS LYMPHOID TISSUE HYPERPLASIA 2
C SMOKING CESSATION THERAPY FACE OEDEMA 1
C SMOKING CESSATION THERAPY URTICARIA 1
C THROMBOSIS CONFUSIONAL STATE 2
C THROMBOSIS DISORIENTATION 2
C THROMBOSIS HALLUCINATION, VISUAL 2
C THROMBOSIS PROPHYLAXIS FACE OEDEMA 1
C THROMBOSIS PROPHYLAXIS URTICARIA 1
C TYPE 2 DIABETES MELLITUS APPARENT LIFE THREATENING EVENT 1
C TYPE 2 DIABETES MELLITUS BLADDER TRANSITIONAL CELL CARCINOMA STAGE III 1
C TYPE 2 DIABETES MELLITUS HAEMATURIA 1
C TYPE 2 DIABETES MELLITUS INTESTINAL FISTULA INFECTION 1
C VENTRICULAR EXTRASYSTOLES DRUG INEFFECTIVE 1
C VENTRICULAR EXTRASYSTOLES TRANSPLANT FAILURE 1
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