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Definity (Perflutren) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Definity (Perflutren) 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 (16)
Death (2)
Life Threatening Events (1)

Reports by Reaction Type

Back Pain (6)Atrial Fibrillation (4)Anxiety (4)Pruritus (3)Unresponsive To Stimuli (3)Ejection Fraction Decreased (3)Pain (2)Headache (2)Viith Nerve Paralysis (2)Fatigue (2)Neck Pain (2)Chest Pain (2)

Possible Definity side effects in 58 year old female

Reported by a physician from United States on 2012-06-27

Patient: 58 year old female, weighing 127.0 kg (279.4 pounds)

Reactions: Myoclonus, Unresponsive To Stimuli, Temporal Lobe Epilepsy, Tardive Dyskinesia

Drug(s) suspected as cause:
Definity



Possible Definity side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-31

Patient: female, weighing 100.0 kg (220.0 pounds)

Reactions: Back Pain, Injection Related Reaction

Drug(s) suspected as cause:
Definity



Possible Definity side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-16

Patient: 67 year old female, weighing 120.0 kg (264.0 pounds)

Reactions: Back Pain, Anxiety, Acute Myocardial Infarction

Drug(s) suspected as cause:
Definity
    Dosage: 2 ml definity diluted with 8 ml normal saline (1 ml), intravenous bolus
    Indication: Cardiac Failure Congestive
    Start date: 2012-04-28
    End date: 2012-04-28

Definity
    Dosage: 2 ml definity diluted with 8 ml normal saline (1 ml), intravenous bolus
    Indication: Echocardiogram
    Start date: 2012-04-28
    End date: 2012-04-28

Definity
    Dosage: 2 ml definity diluted with 8 ml normal saline (1 ml), intravenous bolus
    Indication: Cardiac Failure Congestive
    Start date: 2012-04-28
    End date: 2012-04-28

Definity
    Dosage: 2 ml definity diluted with 8 ml normal saline (1 ml), intravenous bolus
    Indication: Echocardiogram
    Start date: 2012-04-28
    End date: 2012-04-28

Definity
    Dosage: 2 ml definity diluted with 8 ml normal saline (1 ml), intravenous bolus
    Indication: Cardiac Failure Congestive
    Start date: 2012-04-28
    End date: 2012-04-28

Definity
    Dosage: 2 ml definity diluted with 8 ml normal saline (1 ml), intravenous bolus
    Indication: Echocardiogram
    Start date: 2012-04-28
    End date: 2012-04-28

Other drugs received by patient: Lexapro; Iron; Lasix; Losartan Potassium; Metoprolol; Trazodone HCL; Augmentin '125'; Latanoprost; Methylprednisolone; Prandin (Deflazacort); Zocor; Lovenox; Lidocaine; Albuterol; Insulin; Magnesium Oxide; Aspirin; Ipratropium Bromide



Possible Definity side effects in 63 year old male

Reported by a physician from Germany on 2012-05-14

Patient: 63 year old male, weighing 66.0 kg (145.2 pounds)

Reactions: Syncope, Ejection Fraction Decreased, Congestive Cardiomyopathy, Disease Progression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Definity
    Dosage: 1 vial of definity with 8.7 ml of normal saline, intravenous
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-19
    End date: 2011-10-19

Definity
    Dosage: 1 vial of definity with 8.7 ml of normal saline, intravenous
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-08
    End date: 2010-10-08

Definity
    Dosage: 1 vial of definity with 8.7 ml of normal saline, intravenous
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-29
    End date: 2011-06-29

Definity
    Dosage: 1 vial of definity with 8.7 ml of normal saline, intravenous
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-09-29
    End date: 2010-09-29

Other drugs received by patient: Theophylline; Aspirin; Metoprolol Tartrate; Spironolactone; Berodual (Fenoterol Hydrobromide, Ipratropium Bromide); Venlafaxine HCL; Albuterol Sulfate; Beclomethasone / Fenoterol (Beclometasone, Fenoterol); Ramipril; Digitoxin TAB; Topasemid (Torasemide)



Possible Definity side effects in 78 year old male

Reported by a physician from United States on 2012-05-09

Patient: 78 year old male, weighing 85.7 kg (188.6 pounds)

Reactions: Acute Pulmonary Oedema, Agitation, Pruritus, Angioedema, Rales, Wheezing, Delirium, Hypokalaemia, Sinus Tachycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Definity
    Dosage: 1.5 ml definity diluted with 8.5 ml normal saline (0.5 ml), intravenous bolus
    Indication: Cerebrovascular Accident
    Start date: 2012-02-09
    End date: 2012-02-09

Definity
    Dosage: 1.5 ml definity diluted with 8.5 ml normal saline (0.5 ml), intravenous bolus
    Indication: Echocardiogram
    Start date: 2012-02-09
    End date: 2012-02-09

Other drugs received by patient: Lopressor; Hyoscymaine (Hyoscyamine); Hydrodiuril; Zestril; Lipitor; Lovenox; Neurontin



Possible Definity side effects in 63 year old male

Reported by a physician from Germany on 2012-04-17

Patient: 63 year old male

Reactions: Syncope, Ejection Fraction Decreased, Bundle Branch Block Left

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Definity



Possible Definity side effects in 68 year old male

Reported by a consumer/non-health professional from United States on 2012-04-10

Patient: 68 year old male, weighing 97.5 kg (214.5 pounds)

Reactions: Back Pain, Pain in Extremity, Pain

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Definity



Possible Definity side effects in 58 year old male

Reported by a physician from United States on 2012-04-04

Patient: 58 year old male, weighing 144.2 kg (317.3 pounds)

Reactions: Dyspnoea, Pruritus, Unresponsive To Stimuli, Erythema, Flushing, Fatigue, Ocular Hyperaemia, Blood Pressure Decreased, NO Reaction ON Previous Exposure To Drug

Drug(s) suspected as cause:
Definity
    Dosage: see image
    Indication: Cardiomyopathy
    Start date: 2012-03-22
    End date: 2012-03-22

Definity
    Dosage: see image
    Indication: Echocardiogram
    Start date: 2012-03-22
    End date: 2012-03-22

Definity
    Dosage: see image
    Indication: Cardiomyopathy
    Start date: 2012-03-22
    End date: 2012-03-22

Definity
    Dosage: see image
    Indication: Echocardiogram
    Start date: 2012-03-22
    End date: 2012-03-22

Definity
    Dosage: see image
    Indication: Cardiomyopathy
    Start date: 2012-03-22
    End date: 2012-03-22

Definity
    Dosage: see image
    Indication: Echocardiogram
    Start date: 2012-03-22
    End date: 2012-03-22

Other drugs received by patient: Aspirin; Lasix; Quinapril HCL; Coreg



Possible Definity side effects in 44 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-03-06

Patient: 44 year old male, weighing 120.0 kg (264.0 pounds)

Reactions: Nasopharyngitis, Ejection Fraction Decreased, Atrial Fibrillation, Respiratory Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Definity

Other drugs received by patient: Ramipril; Spironolactone; Marcumar; Torsemide; LOC ZOK (Metoprolol Succinate)



Possible Definity side effects in 44 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-03-06

Patient: 44 year old male, weighing 120.0 kg (264.0 pounds)

Reactions: Chest Pain, Atrial Fibrillation, Respiratory Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Definity

Other drugs received by patient: Spironolactone; Marcumar; Metoprolol Succinate; Ramipril; Torsemide



Possible Definity side effects in female

Reported by a pharmacist from United States on 2012-03-02

Patient: female, weighing 103.1 kg (226.8 pounds)

Reactions: Back Pain, Anxiety, Dyspnoea, Fatigue, Pain, Chest Pain, Screaming, Tremor

Drug(s) suspected as cause:
Definity
    Dosage: 3ml -1.5ml vial in 8.5ml ns-
    Indication: Laboratory Test Interference

Definity
    Dosage: 3ml -1.5ml vial in 8.5ml ns-
    Indication: Echocardiogram



Possible Definity side effects in 78 year old male

Reported by a physician from United States on 2012-02-27

Patient: 78 year old male, weighing 85.7 kg (188.6 pounds)

Reactions: Acute Pulmonary Oedema, Pruritus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Definity
    Dosage: 1.5 ml definity diluted with 8.5 ml normal saline (0.5 ml) intravenous bolus
    Indication: Echocardiogram
    Start date: 2012-02-09
    End date: 2012-02-09

Definity
    Dosage: 1.5 ml definity diluted with 8.5 ml normal saline (0.5 ml) intravenous bolus
    Indication: Cerebrovascular Accident
    Start date: 2012-02-09
    End date: 2012-02-09

Other drugs received by patient: Zestril; Lipitor; Hydrodiuril; Lovenox (Enoxaparin Sodiuim); Loppressor (Metoprolol Tartrate); Hyoscyamine (Hyoscyamine); Neurontin



Possible Definity side effects in 50 year old female

Reported by a physician from United States on 2011-12-15

Patient: 50 year old female, weighing 88.9 kg (195.6 pounds)

Reactions: Back Pain, Headache, Viith Nerve Paralysis, Anxiety, Dysarthria, Heart Rate Decreased, Neck Pain, Transient Ischaemic Attack, Blood Pressure Diastolic Decreased

Drug(s) suspected as cause:
Definity

Other drugs received by patient: Tylenol with Codeine (Codeine Phosphate, Paracetamol) (Tablet); Zoloft; Xanax; Aspirin; Potassium Supplement (Potassium); Lasix; Protonix (Pantoprazole Sodium Sesquihydrate)



Possible Definity side effects in 50 year old female

Reported by a physician from United States on 2011-12-06

Patient: 50 year old female, weighing 88.9 kg (195.6 pounds)

Reactions: Dysarthria, Back Pain, Anxiety, Neck Pain, Headache, Transient Ischaemic Attack, Viith Nerve Paralysis

Drug(s) suspected as cause:
Dobutamine (Dobutamine)
    Dosage: 22.9 mg
    Indication: Stress Echocardiogram
    Start date: 2011-11-08
    End date: 2011-11-08

Definity
    Dosage: 1.5 ml definity diluted with 1.5 ml normal saline (0.5 ml, 5 in 1 d), intravenous bolus
    Indication: Chest Pain
    Start date: 2011-11-08
    End date: 2011-11-08

Definity
    Dosage: 1.5 ml definity diluted with 1.5 ml normal saline (0.5 ml, 5 in 1 d), intravenous bolus
    Indication: Stress Echocardiogram
    Start date: 2011-11-08
    End date: 2011-11-08

Other drugs received by patient: Protonix (Pantoprazole Sodium Sesquihydrate); Xanax; Aspirin; Potassium Supplement (Potassium); Zoloft; Tylenol W / Codeine; Lasix



Possible Definity side effects in 69 year old male

Reported by a pharmacist from United States on 2011-10-12

Patient: 69 year old male, weighing 124.5 kg (273.9 pounds)

Reactions: Tachycardia, Unresponsive To Stimuli, Pulse Absent, Atrial Fibrillation, Oxygen Saturation Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Definity



Possible Definity side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-07

Patient: male

Reactions: Cardio-Respiratory Arrest, Atrial Fibrillation, Loss of Consciousness, Pulseless Electrical Activity

Adverse event resulted in: death

Drug(s) suspected as cause:
Definity

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