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Acebutolol (Acebutolol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to 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 (15)
Death (5)

Reports by Reaction Type

Multi-Organ Failure (5)Toxicity To Various Agents (5)Shock (5)Cataract (3)Renal Failure (3)Microtia (2)Malaise (2)External Auditory Canal Atresia (2)Hypotension (2)Congenital Renal Cyst (2)Foetal Exposure During Pregnancy (1)Teratogenicity (1)

Possible Acebutolol side effects in 81 year old female

Reported by a pharmacist from United States on 2012-07-27

Patient: 81 year old female, weighing 68.5 kg (150.7 pounds)

Reactions: Fatigue, Nausea, Hypophagia, Atrial Fibrillation, Bradycardia, Asthenia, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acebutolol

Other drugs received by patient: Furosemide; Methotrexate



Possible Acebutolol side effects in 50 year old female

Reported by a individual with unspecified qualification from United States on 2012-06-28

Patient: 50 year old female, weighing 72.6 kg (159.7 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Acebutolol



Possible Acebutolol side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-18

Patient:

Reactions: Teratogenicity

Drug(s) suspected as cause:
Prednisone
    Indication: Foetal Exposure During Pregnancy

Acebutolol
    Indication: Foetal Exposure During Pregnancy

Mycophenolate Mofetil
    Indication: Foetal Exposure During Pregnancy

Tacrolimus
    Indication: Foetal Exposure During Pregnancy



Possible Acebutolol side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-15

Patient:

Reactions: Congenital Renal Cyst, Foetal Exposure During Pregnancy, Microtia, External Auditory Canal Atresia

Drug(s) suspected as cause:
Tacrolimus

Prednisone

Myfortic
    Dosage: (maternal dose: 0.5 g/day)

Cellcept
    Dosage: (maternal dose: 0.5 g/day)

Acebutolol



Possible Acebutolol side effects in

Reported by a physician from Germany on 2012-05-03

Patient:

Reactions: Congenital Renal Cyst, External Auditory Canal Atresia, Microtia

Drug(s) suspected as cause:
Acebutolol
    Dosage: unk
    Indication: Foetal Exposure During Pregnancy

Prednisone
    Dosage: unk
    Indication: Foetal Exposure During Pregnancy

Tacrolimus
    Dosage: unk
    Indication: Foetal Exposure During Pregnancy

Mycophenolate Mofetil
    Dosage: unk
    Indication: Foetal Exposure During Pregnancy



Possible Acebutolol side effects in 84 year old female

Reported by a consumer/non-health professional from France on 2012-04-26

Patient: 84 year old female

Reactions: Cataract, Renal Failure

Drug(s) suspected as cause:
Clopidogrel
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-01

Pantoprazole
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-01

Acebutolol
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-01

Ranitidine
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-01



Possible Acebutolol side effects in 84 year old female

Reported by a consumer/non-health professional from France on 2012-04-26

Patient: 84 year old female

Reactions: Cataract, Renal Failure

Drug(s) suspected as cause:
Clopidogrel
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-01

Ranitidine
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-01

Pantoprazole
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-01

Acebutolol
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-01



Possible Acebutolol side effects in 84 year old female

Reported by a consumer/non-health professional from France on 2012-04-26

Patient: 84 year old female

Reactions: Cataract, Renal Failure, Drug Hypersensitivity, Myocardial Infarction

Drug(s) suspected as cause:
Acebutolol
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-01

Ranitidine
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-01

Pantoprazole
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-01

Clopidogrel
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-01



Possible Acebutolol side effects in female

Reported by a physician from Japan on 2012-04-10

Patient: female

Reactions: Malaise, Hypotension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Indapamide
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-11-01

Cordarone
    Administration route: Oral
    Indication: Tachycardia
    End date: 2011-11-01

Acebutolol
    Dosage: every day
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-11-01

Candesartan Cilexetil
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-11-01



Possible Acebutolol side effects in 81 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-26

Patient: 81 year old male

Reactions: Malaise, Head Injury, Hypotension, Fall, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ramipril
    Dosage: unk
    Administration route: Oral

Nexium
    Dosage: 20 mg, 1x/day
    Administration route: Oral

Casodex
    Dosage: 80 mg, 1x/day
    Administration route: Oral

Tamsulosin HCL
    Dosage: unk

Acebutolol
    Dosage: unk

Nordaz
    Dosage: unk

Other drugs received by patient: Plavix; Ezetimibe; Pravigard PAC (Copackaged); Acetaminophen; Lantus



Possible Acebutolol side effects in 47 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-29

Patient: 47 year old male

Reactions: Multi-Organ Failure, Toxicity To Various Agents, Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Acebutolol

Ethanol

Ibuprofen



Possible Acebutolol side effects in 86 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-29

Patient: 86 year old male

Reactions: Multi-Organ Failure, Toxicity To Various Agents, Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Acebutolol



Possible Acebutolol side effects in 23 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-29

Patient: 23 year old female

Reactions: Multi-Organ Failure, Toxicity To Various Agents, Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Acebutolol



Possible Acebutolol side effects in 88 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-29

Patient: 88 year old female

Reactions: Multi-Organ Failure, Toxicity To Various Agents, Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Acebutolol



Possible Acebutolol side effects in 47 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-29

Patient: 47 year old male

Reactions: Multi-Organ Failure, Toxicity To Various Agents, Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Ibuprofen

Acebutolol

Ethanol

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