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Pacerone (Amiodarone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Pacerone (Amiodarone) 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 (17)
Death (2)
Life Threatening Events (2)
Disability (1)

Reports by Reaction Type

Dyspnoea (6)Heart Rate Decreased (5)Headache (3)Fatigue (3)Acute Respiratory Distress Syndrome (3)Cardiac Failure Congestive (3)Pulmonary Toxicity (3)Nausea (3)Insomnia (3)Blindness (3)Weight Decreased (2)Nasopharyngitis (2)

Possible Pacerone side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient:

Reactions: Nausea, Drug Intolerance, Headache, Somnolence, Halo Vision, Abnormal Dreams, Optic Neuropathy, Optic Nerve Infarction, Optic Nerve Injury, Blindness

Drug(s) suspected as cause:
Janumet
    Administration route: Oral

Digoxin

Pacerone
    Dosage: 200 mg, qd
    Administration route: Oral

Pacerone
    Dosage: 400 mg, bid
    Administration route: Oral

Other drugs received by patient: Zinc (Unspecified); Coreg; Glyburide; Lipitor; Calcium (Unspecified); Cinnamon; Magnesium (Unspecified); Lisinopril



Possible Pacerone side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-10

Patient: male

Reactions: Pulmonary Toxicity, Dyspnoea, Nasopharyngitis, Pneumonia, Respiratory Failure, Acute Respiratory Distress Syndrome

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Amiodarone Hydrochloride
    Dosage: unk

Cordarone
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Pacerone
    Dosage: unk



Possible Pacerone side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05

Patient: male

Reactions: Pulmonary Toxicity, Nasopharyngitis, Pneumonia, Dyspnoea, Respiratory Failure, Acute Respiratory Distress Syndrome

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cordarone
    Dosage: unk

Amiodarone HCL
    Dosage: unk

Pacerone
    Dosage: unk



Possible Pacerone side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient: male, weighing 93.4 kg (205.6 pounds)

Reactions: Nausea, Balance Disorder, Insomnia, Pain, Dizziness, Headache

Drug(s) suspected as cause:
Pacerone



Possible Pacerone side effects in 86 year old

Reported by a consumer/non-health professional from United States on 2012-05-17

Patient: 86 year old , weighing 66.2 kg (145.6 pounds)

Reactions: Weight Decreased, Condition Aggravated, Hyperaesthesia, Heart Rate Decreased, Fatigue, Diarrhoea, Insomnia, Decreased Appetite, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pacerone
    Dosage: 100 mg, qd, oral
    Administration route: Oral
    Indication: Heart Rate Irregular
    Start date: 2012-04-18

Pacerone
    Dosage: 100 mg, qd, oral
    Administration route: Oral
    Indication: Heart Rate Irregular
    Start date: 2011-12-01
    End date: 2012-04-15

Other drugs received by patient: Lopressor; Aspirin; Lisinopril; Plavix; Potassium Chloride; Lipitor; Digoxin; Furosemide



Possible Pacerone side effects in 53 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-14

Patient: 53 year old male

Reactions: Nausea, Drug Intolerance, Headache, Halo Vision, Somnolence, Abnormal Dreams, Optic Neuropathy, Optic Nerve Injury, Optic Nerve Infarction, Blindness

Drug(s) suspected as cause:
Pacerone
    Dosage: 400;200 mg, bid, oral 400 mg; 200 mg qd, oral
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-01-01
    End date: 2012-04-01

Pacerone
    Dosage: 400;200 mg, bid, oral 400 mg; 200 mg qd, oral
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-01-01
    End date: 2012-01-01

Digoxin

Janumet

Other drugs received by patient: Glyburide; Calcium (Calcium Carbonate); Coreg; Cinnamon (Cinnamomum Verum); Magnesium; Lipitor; Zinc (Zinc); Lisinopril



Possible Pacerone side effects in 86 year old female

Reported by a consumer/non-health professional from United States on 2012-05-08

Patient: 86 year old female, weighing 66.2 kg (145.6 pounds)

Reactions: Weight Decreased, Dyspnoea, Heart Rate Decreased, Fatigue, Hyperaesthesia, Diarrhoea, Insomnia, Cardiac Failure Congestive, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pacerone
    Dosage: 100 mg, qd, oral, 100 mg, qd, oral
    Administration route: Oral
    Indication: Heart Rate Irregular
    Start date: 2012-04-18

Pacerone
    Dosage: 100 mg, qd, oral, 100 mg, qd, oral
    Administration route: Oral
    Indication: Heart Rate Irregular
    Start date: 2011-12-01
    End date: 2012-04-15

Other drugs received by patient: Lisinopril; Furosemide; Lopressor; Potassium Chloride; Digoxin; Aspirin; Plavix; Lipitor



Possible Pacerone side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-03

Patient: male, weighing 68.0 kg (149.7 pounds)

Reactions: Heart Rate Decreased

Drug(s) suspected as cause:
Tikosyn
    Dosage: 125 ug, 2x/day
    Administration route: Oral
    Start date: 2012-03-25

Pacerone
    Dosage: 300 mg, 2x/day
    Start date: 2011-01-01
    End date: 2012-03-23



Possible Pacerone side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-22

Patient: male, weighing 73.5 kg (161.7 pounds)

Reactions: Nervous System Disorder, Hepatic Failure, Hepatitis, Tremor

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Pacerone



Possible Pacerone side effects in 65 year old male

Reported by a consumer/non-health professional from United States on 2012-01-17

Patient: 65 year old male, weighing 106.6 kg (234.5 pounds)

Reactions: Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pacerone



Possible Pacerone side effects in 59 year old male

Reported by a pharmacist from United States on 2012-01-11

Patient: 59 year old male, weighing 115.0 kg (253.0 pounds)

Reactions: Pulmonary Toxicity, Pco2 Decreased, Hypersensitivity, Blood Albumin Decreased, Blood Thyroid Stimulating Hormone Increased, Calcinosis, Protein Total Decreased, Toxicity To Various Agents, Cardiomegaly, Acute Respiratory Distress Syndrome, Electrocardiogram T Wave Inversion, White Blood Cell Count Increased, Pneumonitis, Blood Glucose Increased, Cardiac Failure Congestive

Drug(s) suspected as cause:
Pacerone



Possible Pacerone side effects in 86 year old male

Reported by a consumer/non-health professional from United States on 2011-12-15

Patient: 86 year old male, weighing 63.0 kg (138.7 pounds)

Reactions: Speech Disorder, Quality of Life Decreased, Memory Impairment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pacerone



Possible Pacerone side effects in 67 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-16

Patient: 67 year old male

Reactions: Dyspnoea, Heart Rate Decreased, Thyroid Cancer, Lung Neoplasm Malignant, International Normalised Ratio Decreased, Visual Acuity Reduced, Hypoaesthesia, Paraesthesia

Drug(s) suspected as cause:
Pacerone

Other drugs received by patient: Warfarin Sodium; Three OR Four Unspecified Medications; Metoprolol Tartrate; Omeprazole



Possible Pacerone side effects in male

Reported by a consumer/non-health professional from United States on 2011-11-10

Patient: male, weighing 113.4 kg (249.5 pounds)

Reactions: Optic Nerve Disorder, Drug Interaction, Blindness

Drug(s) suspected as cause:
Pacerone



Possible Pacerone side effects in 67 year old male

Reported by a consumer/non-health professional from United States on 2011-10-27

Patient: 67 year old male

Reactions: Dyspnoea, Heart Rate Decreased, Visual Impairment, International Normalised Ratio Decreased, Pulmonary Mass, Thyroid Neoplasm

Drug(s) suspected as cause:
Pacerone

Other drugs received by patient: Warfarin Sodium; Metoprolol Tartrate; Three OR Four Unspecified Medications; Omeprazole



Possible Pacerone side effects in 76 year old male

Reported by a individual with unspecified qualification from United States on 2011-10-18

Patient: 76 year old male, weighing 118.8 kg (261.5 pounds)

Reactions: Drug Ineffective, Respiratory Distress, Gynaecomastia, Bladder Cancer

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Pacerone



Possible Pacerone side effects in female

Reported by a consumer/non-health professional from United States on 2011-10-07

Patient: female

Reactions: Fatigue, Dyspnoea, Thyroid Disorder, Arrhythmia

Drug(s) suspected as cause:
Amiodarone HCL
    Dosage: unk

Pacerone
    Dosage: unk

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