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Definity Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 1215 

Blood Pressure Systolic Increased, Hypersensitivity, Respiratory Distress, Throat Tightness (6860898-4)
on Jun 30, 2010 Male from UNITED STATES , 60 years of age, weighting 330.0 lb, was diagnosed with
  • coronary artery disease
and was treated with Definity. Directly after, patient experienced the unwanted or unexpected Definity side effects: blood pressure systolic increased, hypersensitivity, respiratory distress, throat tightness. Definity dosage: 1.5 Ml Definity Diluted With 8.5.
Associated medications used:
  • Novolog
  • Lantus (insulin Glsrgine)
  • Simvastatin
  • Metoprolol Tartrate
  • Aspirin
  • Prevacid
  • Bumex
  • Hydralazine Hcl


Abdominal Pain, Asthenia, Back Pain, Bladder Pain, Blood Urine, Burning Sensation, Cellulitis, Chromaturia, Dizziness (6710640-2)
Patient was taking Definity. Patient felt the following Definity side effects: abdominal pain, asthenia, back pain, bladder pain, blood urine, burning sensation, cellulitis, chromaturia, dizziness on May 04, 2010 from UNITED STATES Additional patient health information: Female , 72 years of age, weighting 340.0 lb, was diagnosed with
  • echocardiogram
and. Definity dosage: 1 Time Injected Into Iv.
Multiple prescriptions taken:
  • Vancomycin
  • Lasix
  • Potassium
  • Lipitor
  • Diovan
  • Glyburide
  • Toprol-xl
  • Actos
Patient was hospitalized and became disabled.

Back Pain, Bacterial Test Positive, Blood Pressure Diastolic Decreased, Flank Pain, Flushing, Infusion Site Urticaria, Malaise, Nausea, Somnolence (6692335-7)
Adverse event was reported on Aug 13, 2009 by a Female taking Definity (Dosage: See Image) was diagnosed with
  • echocardiogram
  • right ventricular dysfunction
and. Location: UNITED STATES , 68 years of age, weighting 219.0 lb, After Definity was administered, patient encountered several Definity side effects: back pain, bacterial test positive, blood pressure diastolic decreased, flank pain, flushing, infusion site urticaria, malaise, nausea, somnolence.

Presyncope (6687278-9)
on Mar 30, 2010 Female from UNITED STATES , 60 years of age, was treated with Definity. Directly after, patient experienced the unwanted or unexpected Definity side effects: presyncope. Definity dosage: Intravenous Bolus.


Asthenia, Back Pain, Bladder Dilatation, Bladder Pain, Burning Sensation, Cellulitis, Decreased Activity, Dehydration, Dizziness (6657908-6)
on Mar 11, 2010 Female from UNITED STATES , 72 years of age, weighting 340.0 lb, was diagnosed with
  • echocardiogram
and was treated with Definity. Patient felt the following Definity side effects: asthenia, back pain, bladder dilatation, bladder pain, burning sensation, cellulitis, decreased activity, dehydration, dizziness. Definity dosage: Intravenous.
Multiple prescriptions taken:
  • Bactrim Ds
  • Hydrochlorothiazide
  • Actos
  • Allopurinol
  • Glyburide
  • Diovan
  • Lasix
  • Aspirin
Patient was hospitalized.

Atrial Fibrillation, Atrial Flutter, Cardiac Failure Congestive, Cardiomegaly, Palpitations, Pleural Effusion, Pulmonary Oedema, Respiratory Arrest, Sinus Tachycardia (6657907-4)
Patient was taking Definity. After Definity was administered, patient encountered several Definity side effects: atrial fibrillation, atrial flutter, cardiac failure congestive, cardiomegaly, palpitations, pleural effusion, pulmonary oedema, respiratory arrest, sinus tachycardia on Mar 11, 2010 from UNITED STATES Additional patient health information: Male , 55 years of age, weighting 216.7 lb, was diagnosed with
  • echocardiogram
and. Definity dosage: 5.0 Ml Of Normal Saline Diluted.
Multiple concurrent drugs taken:
  • Aspirin
  • Cardizem Drip (diltiazem)
  • Ativan
  • Duoneb
  • Glucophage
  • Potassium Chloride
  • Lanoxin
  • Lovenox
Patient was hospitalized.

Back Pain, Blood Pressure Increased, Chest Pain, Neck Pain (6657889-5)
Adverse event was reported on Mar 11, 2010 by a Female taking Definity (Dosage: 1.3 Ml Of Definity Diluted) was diagnosed with
  • stress echocardiogram
and. Location: UNITED STATES , 55 years of age, weighting 155.0 lb, Directly after, patient experienced the unwanted or unexpected Definity side effects: back pain, blood pressure increased, chest pain, neck pain.
Associated medications used:
  • Albuterol (salbutamol) (inhalant)
  • Nasonex (mometasone Furoate) (spray (not Inhalation))
  • Prozac
  • Multivitamin (vitamins Nos) (tablests)
  • Calcium (calcium) (tablets)
  • Vitamin D (vitamin D Nos) (tablets)
  • Levothyroxine (levothyroxine)(tablets)
  • Simvastatin (simvastatin) (tablets)
Patient was hospitalized.

Renal Failure, Respiratory Failure (6627685-3)
on Feb 18, 2010 Male from UNITED STATES , 47 years of age, weighting 507.8 lb, was diagnosed with
  • atrial fibrillation
  • echocardiogram
and was treated with Definity. Patient felt the following Definity side effects: renal failure, respiratory failure. Definity dosage: Standard Dilution; 1.3 Ml Of Definity Diluted With 8.7 Ml Of Normal Saline (3 Ml), Intravenous Bolus.

Asthenia, Back Pain, Bladder Pain, Blood Urine, Burning Sensation, Dialysis, Dizziness, Localised Infection (6596494-6)
on Jan 29, 2010 Female from UNITED STATES , 72 years of age, weighting 340.0 lb, was diagnosed with
  • echocardiogram
and was treated with Definity. After Definity was administered, patient encountered several Definity side effects: asthenia, back pain, bladder pain, blood urine, burning sensation, dialysis, dizziness, localised infection. Definity dosage: Intravenous. Patient was hospitalized.

Pulmonary Oedema, Respiratory Arrest, Respiratory Distress (6595740-2)
Patient was taking Definity. Directly after, patient experienced the unwanted or unexpected Definity side effects: pulmonary oedema, respiratory arrest, respiratory distress on Feb 05, 2010 from UNITED STATES Additional patient health information: Patient , 55 years of age, weighting 216.7 lb, was diagnosed with
  • cardiac failure congestive
  • echocardiogram
and. Definity dosage: N/A. Patient was hospitalized.

Pneumonia, Pulmonary Oedema, Respiratory Arrest (6572338-3)
Adverse event was reported on Jan 15, 2010 by a Male taking Definity (Dosage: N/A) was diagnosed with
  • cardiac failure congestive
  • echocardiogram
and. Location: UNITED STATES , 55 years of age, weighting 216.7 lb, Patient felt the following Definity side effects: pneumonia, pulmonary oedema, respiratory arrest. Patient was hospitalized.

Asthenia, Flushing, Hypersensitivity, Hypotension, Nausea, Pruritus (6557736-6)
on Aug 12, 2009 Male from UNITED STATES , 58 years of age, weighting 253.5 lb, was diagnosed with
  • liver transplant
  • stress echocardiogram
and was treated with Definity. After Definity was administered, patient encountered several Definity side effects: asthenia, flushing, hypersensitivity, hypotension, nausea, pruritus. Definity dosage: See Image. Patient was hospitalized.

Atrial Fibrillation (6557733-0)
on Dec 18, 2009 Female from UNITED STATES , 83 years of age, weighting 257.9 lb, was diagnosed with
  • arrhythmia
  • echocardiogram
  • intracardiac thrombus
and was treated with Definity. Directly after, patient experienced the unwanted or unexpected Definity side effects: atrial fibrillation. Definity dosage: See Image. Patient was hospitalized.

Angina Pectoris, Back Pain, Dizziness (6557732-9)
Patient was taking Definity. Patient felt the following Definity side effects: angina pectoris, back pain, dizziness on Dec 04, 2009 from UNITED STATES Additional patient health information: Male , 77 years of age, weighting 195.1 lb, was diagnosed with
  • coronary artery disease
  • echocardiogram
  • ejection fraction
and. Definity dosage: See Image. Patient was hospitalized.

Agitation, Atrial Fibrillation, Back Pain, Chest Pain, Headache, Neck Pain, Ventricular Tachycardia (6557720-2)
Adverse event was reported on Nov 18, 2009 by a Male taking Definity (Dosage: See Image) was diagnosed with
  • chest discomfort
  • stress echocardiogram
and. Location: UNITED STATES , 71 years of age, weighting 229.0 lb, After Definity was administered, patient encountered several Definity side effects: agitation, atrial fibrillation, back pain, chest pain, headache, neck pain, ventricular tachycardia. Patient was hospitalized.

Hypersensitivity (6557704-4)
on Oct 29, 2009 Female from UNITED STATES , 39 years of age, weighting 166.0 lb, was diagnosed with
  • cardiac stress test
and was treated with Definity. Directly after, patient experienced the unwanted or unexpected Definity side effects: hypersensitivity. Definity dosage: 1 Vial Diluted In 50 Ml X2,intravenous.
Associated medications used:
  • Dobutamine (dobutamine)
Patient was hospitalized.

Convulsion (6557701-9)
on Oct 19, 2009 Male from UNITED STATES , 48 years of age, weighting 220.5 lb, was diagnosed with
  • chest pain
  • stress echocardiogram
and was treated with Definity. Patient felt the following Definity side effects: convulsion. Definity dosage: (0.3 Ml),intravenous Bolus ; 0.3 Ml (0.1 Ml, 3 In 1 D),intravenous Bolus.

Blood Pressure Increased, Dizziness, Nausea (6557688-9)
Patient was taking Definity. After Definity was administered, patient encountered several Definity side effects: blood pressure increased, dizziness, nausea on Oct 06, 2009 from UNITED STATES Additional patient health information: Female , 60 years of age, weighting 230.0 lb, was diagnosed with
  • cardiac murmur
  • echocardiogram
  • parathyroid gland operation
  • preoperative care
and. Definity dosage: 1.5 Ml Definity Diluted In 8.5 Mlof Normal Saline (0.5 Ml),intravenous. Patient was hospitalized.

Atrial Fibrillation, Grand Mal Convulsion, Ventricular Extrasystoles (6557646-4)
Adverse event was reported on Sep 29, 2009 by a Male taking Definity (Dosage: .5 Ml Of Undilluted Definity Followed With 1 Ml Of Normal Saline Flush (0.5 Ml),intravenous Bolus) was diagnosed with
  • echocardiogram
  • ejection fraction
and. Location: UNITED STATES , 63 years of age, weighting 183.0 lb, Directly after, patient experienced the unwanted or unexpected Definity side effects: atrial fibrillation, grand mal convulsion, ventricular extrasystoles.

Dyspnoea, Hypertension, Hypoxia, Wheezing (6557630-0)
on Sep 15, 2009 Female from UNITED STATES , 52 years of age, weighting 210.0 lb, was diagnosed with
  • cardiac stress test
  • chest pain
and was treated with Definity. Patient felt the following Definity side effects: dyspnoea, hypertension, hypoxia, wheezing. Definity dosage: 1.3 Ml Definity Diluted With 9 Ml Ns (2 Ml), Intravenous Bolus.

Angina Pectoris, Back Pain, Nausea (6557626-9)
on Sep 10, 2009 Male from UNITED STATES , 74 years of age, weighting 180.0 lb, was diagnosed with
  • chest pain
  • stress echocardiogram
and was treated with Definity. After Definity was administered, patient encountered several Definity side effects: angina pectoris, back pain, nausea. Definity dosage: 1.3 Ml Of Definity Diluted In 8.7 Ml Of Ns (2ml) Intravenous Bolus. Patient was hospitalized.

Hypersensitivity (6557617-8)
Patient was taking Definity. Directly after, patient experienced the unwanted or unexpected Definity side effects: hypersensitivity on Aug 10, 2009 from UNITED STATES Additional patient health information: Male , 88 years of age, was diagnosed with
  • echocardiogram
and. Definity dosage: 1.5 Ml Of Definity Diluted In 8.5 Ml Of Normal Saline (2 Ml), Intravenous.

Cardiac Arrest, Flushing, Respiratory Arrest, Shock, Sinus Tachycardia (6386211-7)
Adverse event was reported on Feb 13, 2009 by a Male taking Definity (Dosage: N/A) was diagnosed with
  • echocardiogram
and. Location: UNITED STATES , 59 years of age, weighting 295.0 lb, Patient felt the following Definity side effects: cardiac arrest, flushing, respiratory arrest, shock, sinus tachycardia. Patient was hospitalized.

Blood Pressure Decreased, Flushing, Nausea, Vision Blurred (6386210-5)
on Feb 02, 2009 Female from UNITED STATES , 67 years of age, weighting 326.3 lb, was diagnosed with
  • echocardiogram
and was treated with Definity. After Definity was administered, patient encountered several Definity side effects: blood pressure decreased, flushing, nausea, vision blurred. Definity dosage: N/A.
Multiple concurrent drugs taken:
  • Actos
  • Premarin
  • Simvastatin
  • Meloxicam
  • Torsemide
  • Lisinopril
  • Carvedilol
  • Hydrocodone


Bradycardia, Defaecation Urgency, Hyperhidrosis, Hypotension, Nausea (6386208-7)
on Jan 05, 2009 Male from UNITED STATES , 60 years of age, weighting 216.1 lb, was diagnosed with
  • echocardiogram
and was treated with Definity. Directly after, patient experienced the unwanted or unexpected Definity side effects: bradycardia, defaecation urgency, hyperhidrosis, hypotension, nausea. Definity dosage: 2 Ml.
Associated medications used:
  • Aspirin
  • Coreg
  • Digoxin
  • Neurontin
  • Nph Insulin
  • Insulin Lispro
  • Imdur
  • Lisinopril


Showing 1-25 of 1215 

Definity Health Episodes

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Record and Track Your Side Effects

It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Definity Information

Alternative DEFINITY Names:PERFLUTRE

Active Ingredient: PERFLUTRE

More About Definity

Side Effects reported to FDA: 1215. View Definity Adverse Reports

Definity safety alerts: 2008 2007

Reported deaths: 31

Reported hospitalizations: 114

Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)

Audience: Radiological healthcare professionals, cardiologists, hospital risk managers 

[Posted 07/17/2008] FDA is updating healthcare professionals about recent changes made to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information for micro-bubble contrast agents, a sterile suspension of perflutren gas microspheres, indicated for use in certain patients with suboptimal echocardiograms, to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.These changes reflect conclusions of FDA reviews of information received following the addition of new Contraindications and Warnings in October 2007. The revised Boxed Warning and Warnings highlight the risk of serious cardiopulmonary reactions during or within 30 minutes following the administration of these products and recommend that high risk patients with pulmonary hypertension or unstable cardiopulmonary conditions be closely monitored during and for at least 30 minutes post administration of these contrast agents. In addition, several of the Contraindications that were added to the labeling in October, 2007 were removed because FDA determined that, in some patients, the benefits from the diagnostic information obtained through the use of Definity or Optison may outweigh the risk for serious cardiopulmonary reactions, even among some patients at particularly high risk for these reactions.

[July 17, 2008 - Information for Healthcare Professionals - FDA] 
[June 2008 - Dear Healthcare Professional Letter - GE] 
[May 2008 - Dear Healthcare Professional Letter - Lantheus Medical Imaging]

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