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Sectral (Acebutolol) - Side Effect Reports to FDA

 
 



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 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 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 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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