This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Sectral (Acebutolol) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (20)
Death (2)
Life Threatening Events (4)
Reports by Reaction Type
Hyperkalaemia (8),
Confusional State (6),
Pruritus (4),
Lactic Acidosis (4),
Malaise (4),
Electrocardiogram QRS Complex Prolonged (4),
Renal Failure Acute (4),
Rash Papular (4),
Dehydration (4),
Hypotension (3),
Hyponatraemia (3),
Cognitive Disorder (3)
Possible Sectral side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-10
Patient: female
Reactions: Fear of Falling, Psychomotor Skills Impaired, Visual Impairment, Hypotension, General Physical Health Deterioration, Gait Disturbance, Fall, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lasix
Dosage: 40 mg, daily
Administration route: Oral
End date: 2010-03-01
Sectral
End date: 2010-03-01
Valsartan
Dosage: 160 mg, daily
Administration route: Oral
End date: 2010-03-01
Duspatalin
Dosage: 400 mg, daily
Administration route: Oral
End date: 2010-03-01
Possible Sectral side effects in 77 year old female
Reported by a physician from France on 2012-07-17
Patient: 77 year old female
Reactions: Grand MAL Convulsion, Coma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Taxol
Dosage: restarted:14jun2012
Indication: Breast Cancer Metastatic
Start date: 2012-06-07
Femara
Administration route: Oral
Indication: Breast Cancer Metastatic
Start date: 2012-06-07
Lorazepam
Administration route: Oral
Indication: Anxiety
Stablon
Administration route: Oral
Indication: Depression
Start date: 2012-06-07
End date: 2012-06-08
Lorazepam
Administration route: Oral
Indication: Depression
Sectral
Administration route: Oral
Possible Sectral side effects in 84 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-05
Patient: 84 year old female
Reactions: Antinuclear Antibody Positive, Retinal Haemorrhage, Lupus-Like Syndrome, Hypotension, Thrombocytopenia, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Amlodipine Besylate
Dosage: 5 mg, 1x/day
Administration route: Oral
End date: 2011-12-15
Sectral
Dosage: 500 mg, 1x/day
Administration route: Oral
End date: 2011-12-21
Other drugs received by patient: Novorapid Flexpen; Atorvastatin; Nitroglycerin; Lantus; Ikorel; Adancor; Kardegic; Omeprazole
Possible Sectral side effects in 84 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-05
Patient: 84 year old female
Reactions: Antinuclear Antibody Positive, Lupus-Like Syndrome, Retinal Haemorrhage, Hypotension, Thrombocytopenia, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sectral
Dosage: 500 mg, 1x/day
Administration route: Oral
End date: 2011-12-21
Amlodipine Besylate
Dosage: 5 mg, 1x/day
Administration route: Oral
End date: 2011-12-15
Other drugs received by patient: Nitroglycerin; Ikorel; Atorvastatin; Adancor; Novorapid Flexpen; Lantus; Kardegic; Omeprazole
Possible Sectral side effects in 89 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-01
Patient: 89 year old female
Reactions: Malaise, Renal Failure, Hyperkalaemia, Diarrhoea, Atrioventricular Block Complete, Sinoatrial Block
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aceon
Dosage: 5 mg, qd, oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-12-01
Sectral
Dosage: 200 mq, qd, oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2002-01-01
End date: 2012-03-03
Other drugs received by patient: Lasix; Allopurinol; Levothyroxine Sodium; Omeprazole; Sintrom
Possible Sectral side effects in 50 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-02-16
Patient: 50 year old male
Reactions: Pruritus, Rash Papular
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Plavix
Dosage: 75 mg, 1x/day
Administration route: Oral
Perindopril Erbumine
Dosage: 7.5 mg, 1x/day
Administration route: Oral
Start date: 2011-10-19
Sectral
Dosage: 200mg in the morning, 100mg in the evening
Administration route: Oral
Start date: 2011-10-19
Plavix
Dosage: 75 mg, 2x/week
Administration route: Oral
Start date: 2011-10-19
Atorvastatin
Dosage: 80 mg, 1x/day
Administration route: Oral
Start date: 2011-10-19
Aspirin
Dosage: 2 df, 1x/day
Administration route: Oral
Start date: 2011-10-19
Possible Sectral side effects in 50 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-18
Patient: 50 year old male
Reactions: Pruritus, Rash Papular
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Plavix
Dosage: 75 mg, 1x/day
Administration route: Oral
Aspirin
Dosage: 200 mg, 1x/day
Administration route: Oral
Start date: 2011-10-19
Plavix
Dosage: 75 mg, 2x/week
Administration route: Oral
Start date: 2011-10-19
Sectral
Dosage: unk
Administration route: Oral
Start date: 2011-10-19
Perindopril Erbumine
Dosage: 7.5 mg, 1x/day
Administration route: Oral
Start date: 2011-10-19
Atorvastatin Calcium
Dosage: 80 mg, 1x/day
Administration route: Oral
Start date: 2011-10-19
Possible Sectral side effects in 50 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-10
Patient: 50 year old male
Reactions: Pruritus, Rash Papular
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Atorvastatin Calcium
Dosage: 80 mg, 1x/day
Administration route: Oral
Start date: 2011-10-19
Plavix
Dosage: 75 mg, 1x/day
Administration route: Oral
Sectral
Dosage: unk
Administration route: Oral
Start date: 2011-10-19
Aspegic 325
Dosage: 100 mg, 2x/day
Administration route: Oral
Start date: 2011-10-19
Plavix
Dosage: 75 mg, 2x/week
Administration route: Oral
Start date: 2011-10-19
Perindopril Erbumine
Dosage: 7.5 mg, 1x/day
Administration route: Oral
Start date: 2011-10-19
Possible Sectral side effects in 88 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-10
Patient: 88 year old male
Reactions: Malaise, Hyperkalaemia, Hyponatraemia, Cognitive Disorder, Bradycardia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sectral
Dosage: 200 mg, 2x/day
Administration route: Oral
Start date: 2005-01-01
End date: 2011-10-01
Nexium
Dosage: 40 mg, 2x/day
Administration route: Oral
Start date: 2005-01-01
Imovane
Dosage: 7.5 mg, daily
Administration route: Oral
Start date: 2005-01-01
Ramipril
Dosage: 10 mg, daily
Administration route: Oral
Indication: Myocardial Ischaemia
Start date: 2005-01-01
Other drugs received by patient: Amlodipine Besylate; Fenofibrate; Bromazepam; Plavix
Possible Sectral side effects in 50 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-05
Patient: 50 year old male
Reactions: Pruritus, Rash Papular
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aspegic 325
Dosage: 100 mg, 1x/day
Administration route: Oral
Start date: 2011-10-19
Perindopril Erbumine
Dosage: 1 mg, 1x/day
Administration route: Oral
Start date: 2011-10-19
Sectral
Dosage: unk
Administration route: Oral
Start date: 2011-10-19
Atorvastatin Calcium
Dosage: 80 mg, 1x/day
Administration route: Oral
Start date: 2011-10-19
Plavix
Dosage: 75 mg, 1x/day
Administration route: Oral
Plavix
Dosage: 75 mg, 2x/week
Administration route: Oral
Start date: 2011-10-19
Possible Sectral side effects in 88 year old male
Reported by a physician from France on 2011-12-16
Patient: 88 year old male
Reactions: Malaise, Hyperkalaemia, Hyponatraemia, Cognitive Disorder, Bradycardia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sectral
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2005-01-01
End date: 2011-10-01
Ramipril
Administration route: Oral
Start date: 2011-10-01
Imovane
Administration route: Oral
Start date: 2005-01-01
Nexium
Administration route: Oral
Start date: 2005-01-01
End date: 2011-10-01
Nexium
Administration route: Oral
Start date: 2011-10-01
Ramipril
Administration route: Oral
Indication: Myocardial Ischaemia
Start date: 2005-01-01
End date: 2011-10-01
Other drugs received by patient: Fenofibrate; Lexomil Roche; Amlodipine Besylate; Plavix
Possible Sectral side effects in 88 year old male
Reported by a physician from France on 2011-12-01
Patient: 88 year old male
Reactions: Malaise, Hyperkalaemia, Hyponatraemia, Bradycardia, Cognitive Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Start date: 2005-01-01
Ramipril
Administration route: Oral
Indication: Myocardial Ischaemia
Start date: 2005-01-01
End date: 2011-01-01
Imovane
Administration route: Oral
Start date: 2005-01-01
Sectral
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2005-01-01
End date: 2011-10-01
Other drugs received by patient: Plavix; Lexomil Roche; Fenofibrate; Amlodipine Besylate
Possible Sectral side effects in 78 year old male
Reported by a consumer/non-health professional from France on 2011-11-30
Patient: 78 year old male
Reactions: Agitation, Confusional State, Dyskinesia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Rifampin and Isoniazid
Dosage: 150 mg, 1x/day:qd
Administration route: Oral
Start date: 2000-03-30
End date: 2000-05-24
Rifampin and Isoniazid
Dosage: 300 mg, 1x/day:qd
Indication: Pleuropericarditis
Start date: 2000-03-30
End date: 2000-05-24
Prozac
Dosage: 40 mg, 1x/day:qd
Administration route: Oral
Start date: 2000-05-10
End date: 2000-05-17
Solian
Dosage: 50 mg, 2x/day:bid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2000-05-10
End date: 2011-05-17
Prozac
Dosage: 20 mg, 1x/day:qd
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2000-04-27
End date: 2000-05-09
Myambutol
Dosage: 1200 mg, unknown
Administration route: Oral
Indication: Pleuropericarditis
Start date: 2000-03-30
End date: 2000-05-24
Midodrine Hydrochloride
Dosage: 2.5 mg, 3x/day:tid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2000-04-15
End date: 2000-05-17
Sectral
Dosage: 100 mg, unknown
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2000-03-15
End date: 2000-05-17
Other drugs received by patient: Diamicron; Praxinor / 00276601 /; Imovane; Forlax / 00754501 /
Possible Sectral side effects in 78 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2011-11-24
Patient: 78 year old male
Reactions: Confusional State, Agitation, Dyskinesia, Sudden Death, Arrhythmia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Rifampin and Isoniazid
Dosage: 300 mg, 1x/day:qd
Indication: Pleuropericarditis
Start date: 2000-03-30
End date: 2000-05-24
Prozac
Dosage: 20 mg, 1x/day:qd
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2000-04-27
End date: 2000-05-09
Sectral
Dosage: 100 mg, unknown
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2000-03-15
End date: 2000-05-17
Midodrine Hydrochloride
Dosage: 2.5 mg, 3x/day:tid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2000-04-15
End date: 2000-05-17
Solian
Dosage: 50 mg, 2x/day:bid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2000-05-10
End date: 2011-05-17
Rifampin and Isoniazid
Dosage: 150 mg, 1x/day:qd
Administration route: Oral
Start date: 2000-03-30
End date: 2000-05-24
Myambutol
Dosage: 1200 mg, unknown
Administration route: Oral
Indication: Pleuropericarditis
Start date: 2000-03-30
End date: 2000-05-24
Prozac
Dosage: 40 mg, 1x/day:qd
Administration route: Oral
Start date: 2000-05-10
End date: 2000-05-17
Other drugs received by patient: Praxinor / 00276601 /; Imovane; Diamicron; Forlax / 00754501 /
Possible Sectral side effects in 71 year old female
Reported by a health professional (non-physician/pharmacist) from Germany on 2011-11-08
Patient: 71 year old female
Reactions: Confusional State, Hyperkalaemia, Electrocardiogram QRS Complex Prolonged, Dehydration, Lactic Acidosis, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Atacand
Dosage: formu: 16mg tabs
Administration route: Oral
Indication: Hypertension
End date: 2011-07-21
Aldactone
Dosage: form: 25mg tabs
Administration route: Oral
Indication: Cardiac Failure
End date: 2011-07-21
Glucophage
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
End date: 2011-07-21
Sectral
Dosage: form: 200mg tabs
Administration route: Oral
Indication: Hypertension
End date: 2011-07-21
Other drugs received by patient: Rabeprazole Sodium; Previscan; Lasix; Calcium Carbonate; Cordarone
Possible Sectral side effects in female
Reported by a physician from France on 2011-10-26
Patient: female
Reactions: Confusional State, Lactic Acidosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aldactone
Administration route: Oral
Indication: Cardiac Failure
End date: 2011-07-21
Atacand
Administration route: Oral
Indication: Hypertension
End date: 2011-07-21
Sectral
Administration route: Oral
Indication: Hypertension
End date: 2011-07-21
Glucophage
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
End date: 2011-07-21
Other drugs received by patient: Cordarone; Rabeprazole Sodium; Lasix; Previscan; Cacit Vitamine D3
Possible Sectral side effects in 71 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2011-10-25
Patient: 71 year old female
Reactions: Confusional State, Electrocardiogram QRS Complex Prolonged, Diarrhoea, Hyperkalaemia, Dehydration, Lactic Acidosis, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Aldactone
Dosage: 25 mg, 1x/day
Administration route: Oral
Indication: Cardiac Failure
End date: 2011-07-21
Atacand
Dosage: 16 mg, 1x/day
Administration route: Oral
Indication: Hypertension
End date: 2011-07-21
Glucophage
Dosage: 850 mg, 3x/day
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
End date: 2011-07-21
Sectral
Dosage: 200 mg, 1x/day
Administration route: Oral
Indication: Hypertension
End date: 2011-07-21
Other drugs received by patient: Calcium Carbonate; Lasix; Previscan; Rabeprazole Sodium; Cordarone
Possible Sectral side effects in female
Reported by a physician from France on 2011-10-24
Patient: female
Reactions: Electrocardiogram QRS Complex Prolonged, Hyperkalaemia, Dehydration, Renal Failure Acute
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Glucophage
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
End date: 2011-07-21
Sectral
Administration route: Oral
Indication: Hypertension
End date: 2011-07-21
Atacand
Administration route: Oral
Indication: Hypertension
End date: 2011-07-21
Aldactone
Administration route: Oral
Indication: Cardiac Failure
End date: 2011-07-21
Other drugs received by patient: Rabeprazole Sodium; Previscan; Lasix; Cordarone; Cacit Vitamine D3
Possible Sectral side effects in 49 year old female
Reported by a consumer/non-health professional from United States on 2011-10-24
Patient: 49 year old female, weighing 82.9 kg (182.4 pounds)
Reactions: Hypothyroidism
Drug(s) suspected as cause:
Sectral
Other drugs received by patient: Synthroid; Dyazide; Vivelle-DOT; Prometrium; Cytomel; Synthroid
Possible Sectral side effects in 71 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2011-10-20
Patient: 71 year old female
Reactions: Confusional State, Electrocardiogram QRS Complex Prolonged, Diarrhoea, Hyperkalaemia, Dehydration, Lactic Acidosis, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Atacand
Dosage: 16 mg, 1x/day
Administration route: Oral
Indication: Hypertension
End date: 2011-07-21
Glucophage
Dosage: 850 mg, 3x/day
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
End date: 2011-07-21
Aldactone
Dosage: 25 mg, 1x/day
Administration route: Oral
Indication: Cardiac Failure
End date: 2011-07-21
Sectral
Dosage: 200 mg, 1x/day
Administration route: Oral
Indication: Hypertension
End date: 2011-07-21
Other drugs received by patient: Previscan; Calcium Carbonate; Rabeprazole Sodium; Cordarone; Lasix
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