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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