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Definity Side Effects

Common Definity Side Effects

The most commonly reported Definity side effects (click to view or check a box to report):

Back Pain (653)
Dyspnoea (116)
Urticaria (103)
Flushing (88)
Chest Pain (83)
Headache (71)
Muscle Spasms (64)
Pruritus (58)
Dizziness (57)
Pain In Extremity (55)
Nausea (48)
Hypotension (43)
Arthralgia (40)
Chest Discomfort (36)
Cardiac Arrest (34)
Rash (33)
Hyperhidrosis (32)
Feeling Hot (30)
Blood Pressure Increased (26)
Erythema (24)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Definity Side Effects Reported to FDA

The following Definity reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Definity on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Hypoxia, Syncope, Rales, Cardiac Failure, Condition Aggravated
on Nov 04, 2013 Male from US , 70 years of age, weighting 320.0 lb, was diagnosed with and was treated with Definity. Directly after, patient experienced the unwanted or unexpected Definity side effects: hypoxia, syncope, rales, cardiac failure, condition aggravated. Definity dosage: 1 Vial Definity Diluted In 8 Ml.
Associated medications used:
  • Albuterol
  • Lasix
  • Pravachol
  • Coumadin
  • Plavix
  • Coreg
  • Tylenol
Patient was hospitalized.

Lip Swelling, Rash, Rosacea
Patient was taking Definity. Patient felt the following Definity side effects: lip swelling, rash, rosacea on Jan 23, 2014 from US Additional patient health information: Female , 51 years of age, weighting 319.7 lb, was diagnosed with and. Definity dosage: N/A.

Pain, Heart Rate Increased, Dyspnoea, Muscle Spasms
Adverse event was reported on Jan 09, 2014 by a Female taking Definity (Dosage: Iv Push) was diagnosed with and. Location: US , 55 years of age, weighting 243.6 lb, After Definity was administered, patient encountered several Definity side effects: pain, heart rate increased, dyspnoea, muscle spasms.

Flushing, Restlessness, Swelling, Ocular Hyperaemia, Unevaluable Event
on Dec 17, 2013 Male from US , 64 years of age, weighting 220.0 lb, was diagnosed with and was treated with Definity. Directly after, patient experienced the unwanted or unexpected Definity side effects: flushing, restlessness, swelling, ocular hyperaemia, unevaluable event. Definity dosage: N/A.


Ejection Fraction Decreased, Anaphylactic Reaction
on Dec 13, 2013 Male from US , 84 years of age, was diagnosed with and was treated with Definity. Patient felt the following Definity side effects: ejection fraction decreased, anaphylactic reaction. Definity dosage: N/A.

Blood Pressure Decreased, Oxygen Saturation Decreased, Flushing, Rash
Patient was taking Definity (perflutren). After Definity was administered, patient encountered several Definity side effects: blood pressure decreased, oxygen saturation decreased, flushing, rash on Dec 03, 2013 from US Additional patient health information: Male , 61 years of age, was diagnosed with and. Definity (perflutren) dosage: 1 Vial Definity With 8.3 Ml Normal Saline (2 Ml), Intravenous Bolus.
Multiple concurrent drugs taken:
  • Hydrochlorothiazide (hydrochlorothiazide)
  • Aceon (perindopril Erbumine)


Muscle Spasms
Adverse event was reported on Nov 11, 2013 by a Female taking Definity (Dosage: N/A) was diagnosed with and. Location: US , 57 years of age, weighting 198.0 lb, Directly after, patient experienced the unwanted or unexpected Definity side effects: muscle spasms.

Abdominal Pain, Muscle Rigidity, Unresponsive To Stimuli, Convulsion, Faecal Incontinence
on Oct 25, 2013 Male from US , 46 years of age, weighting 134.5 lb, was diagnosed with and was treated with Definity. Patient felt the following Definity side effects: abdominal pain, muscle rigidity, unresponsive to stimuli, convulsion, faecal incontinence. Definity dosage: Undiluted 0.3 Ml, Intravenous Bolus.
Multiple prescriptions taken:
  • Albuterol (salbutamol)
  • Amiodarone
  • Lovenox (enoxaparin Sodium)
  • Advair (fluticasone Propionate, Salmeterol Xinafoate)
  • Lasix (furosemide)
  • Singulair
  • Aldactone (spironolactone)
  • Coreg (carvedilol)


Electrocardiogram St Segment Elevation, Right Ventricular Dysfunction, Anaphylactic Shock
on Sep 19, 2013 Male from US , 76 years of age, weighting 260.1 lb, was diagnosed with and was treated with Definity. After Definity was administered, patient encountered several Definity side effects: electrocardiogram st segment elevation, right ventricular dysfunction, anaphylactic shock. Definity dosage: 1 Vial Of Definity Diluted 8.7 Ml Normal Saline (2ml) Intravenous Bolus.
Multiple concurrent drugs taken:
  • Lisinopril (lisinopril)
  • Zocor (simvastatin)
Patient was hospitalized.

Anaphylactic Reaction
Patient was taking Definity (perflutren) 1 Ml Definity Diluted With 9 Ml Normal Saline (2 Ml), Intravenous B0lus. Directly after, patient experienced the unwanted or unexpected Definity side effects: anaphylactic reaction on May 08, 2013 from US Additional patient health information: Male , 31 years of age, was diagnosed with and. Definity (perflutren) 1 Ml Definity Diluted With 9 Ml Normal Saline (2 Ml), Intravenous B0lus dosage: 1 Ml Definity Diluted With 9 Ml Normal Saline (2 Ml ), Intravenous Bolus.

Respiratory Distress, Acute Pulmonary Oedema, Ejection Fraction Decreased, Mitral Valve Incompetence
Adverse event was reported on Sep 16, 2013 by a Female taking Definity (Dosage: N/A) was diagnosed with and. Location: US , 51 years of age, Patient felt the following Definity side effects: respiratory distress, acute pulmonary oedema, ejection fraction decreased, mitral valve incompetence. Patient was hospitalized.

Flushing, Dyspnoea, Nausea
on Sep 16, 2013 Female from US , 22 years of age, weighting 123.0 lb, was diagnosed with and was treated with Definity. After Definity was administered, patient encountered several Definity side effects: flushing, dyspnoea, nausea. Definity dosage: N/A.

Back Pain, Muscle Spasms
on Sep 04, 2013 Female from US , 68 years of age, weighting 128.0 lb, was diagnosed with and was treated with Definity. Directly after, patient experienced the unwanted or unexpected Definity side effects: back pain, muscle spasms. Definity dosage: Given Once For Pre-stress Echo Images.
Associated medications used:
  • Acebutolol
  • Norvasc
  • Lipitor
  • Aspirin
  • Co-enzyme Q-10
  • Vitamin B12
  • Folic Acid
  • Mag-ox


Anaphylactic Reaction, Dysgeusia, Paraesthesia Oral, Rash, Hypotension
Patient was taking Definity. Patient felt the following Definity side effects: anaphylactic reaction, dysgeusia, paraesthesia oral, rash, hypotension on Aug 29, 2013 from US Additional patient health information: Female , 84 years of age, weighting 104.0 lb, was diagnosed with and. Definity dosage: 1 Vial Diluted With 8.5 Ml Of Normal Saline (2 Ml).
Multiple prescriptions taken:
  • Albuterol (slbutamol)
  • Aspirin (acetylsalicylic Acid)
  • Cozaar (losartan Potassium)
  • Zocor (simvastatin)
  • Coreg (carvedilol)
  • Heparin (heparin)


Anaphylactic Reaction
Adverse event was reported on Sep 30, 2013 by a Female taking Definity (Dosage: N/A) was diagnosed with and. Location: US , 65 years of age, After Definity was administered, patient encountered several Definity side effects: anaphylactic reaction.
Multiple concurrent drugs taken:
  • Albuterol (salbutamol)
  • Aspirin (acetylsalicylic Acid)
  • Cortrosyn (tetracosactide)
  • Ferrus Sulphate (ferrous Sulfate)
  • Humulin (insulin Humam, Insulin Human Injection, Sophane)
  • Lovenox (enoxaparin Sodium)
  • Mag-all (magnesium Hydroxide, Simeticone, Aluminium Hydroxide)
  • Magnesium Oxide (magnesium Oxide)


Muscle Spasms
on Aug 23, 2013 Male from US , 60 years of age, weighting 180.8 lb, was diagnosed with and was treated with Definity. Directly after, patient experienced the unwanted or unexpected Definity side effects: muscle spasms. Definity dosage: N/A.

Back Pain
on Aug 08, 2013 Male from US , 54 years of age, weighting 280.0 lb, was diagnosed with and was treated with Definity. Patient felt the following Definity side effects: back pain. Definity dosage: N/A.

Cardiac Arrest, Pulseless Electrical Activity, Ventricular Fibrillation, Bundle Branch Block Right, Atrioventricular Block Complete, Brain Injury
Patient was taking Definity. After Definity was administered, patient encountered several Definity side effects: cardiac arrest, pulseless electrical activity, ventricular fibrillation, bundle branch block right, atrioventricular block complete, brain injury on Jul 26, 2013 from CA Additional patient health information: Male , 76 years of age, was diagnosed with and. Definity dosage: N/A.

Presyncope, Hypotension, Dizziness, Posture Abnormal, Hypothyroidism, Hypokalaemia, Dehydration
Adverse event was reported on Jul 23, 2013 by a Male taking Definity (Dosage: N/A) was diagnosed with and. Location: US , 73 years of age, weighting 226.0 lb, Directly after, patient experienced the unwanted or unexpected Definity side effects: presyncope, hypotension, dizziness, posture abnormal, hypothyroidism, hypokalaemia, dehydration.
Associated medications used:
  • Coumadin (warfarin Sodium)
  • Amiodarone (amiodarone)
  • Lasix (furosemide)
Patient was hospitalized.

Dyspnoea, Oxygen Saturation Decreased
on Jun 19, 2013 Male from US , 48 years of age, weighting 245.0 lb, was diagnosed with and was treated with Definity. Patient felt the following Definity side effects: dyspnoea, oxygen saturation decreased. Definity dosage: 1.3 Ml Defintiy Diluted With 8.7 Ml Normal Saline (2.5 Ml), Intravenous Bolus.
Multiple prescriptions taken:
  • Flexeril (cyclobenzaprine Hydrochloride)
  • Vicodin
  • Fentanyl Patch (fentanyl)
  • Amlodipine (amlodipine)


Cough, Dyspnoea, Oxygen Saturation Decreased, Myocardial Infarction
on May 15, 2013 Female from US , 62 years of age, weighting 213.0 lb, was diagnosed with and was treated with Definity. After Definity was administered, patient encountered several Definity side effects: cough, dyspnoea, oxygen saturation decreased, myocardial infarction. Definity dosage: 1.5ml Defintiy Diltued With 8.5 Ml Normal (3ml, Intravenous Bolus).
Multiple concurrent drugs taken:
  • Simvastatin (simvastatin)
  • Metformin (metformin)
  • Lisinopril (lisinopril)
  • Insulin (insulin)
  • Glimepiride (glimepiride)
  • Fish Oil (fish Oil)
  • Calcium Carbonate (calcium Carbonate)
  • D3 (colecalciferol)


Nausea, Presyncope, Convulsion, Unresponsive To Stimuli, Pulse Absent, Blood Pressure Immeasurable
Patient was taking Definity. Directly after, patient experienced the unwanted or unexpected Definity side effects: nausea, presyncope, convulsion, unresponsive to stimuli, pulse absent, blood pressure immeasurable on May 03, 2013 from US Additional patient health information: Female , weighting 169.0 lb, was diagnosed with and. Definity dosage: 1 Vial Definity Diluted With 8 Ml Normal Saline (3 Ml, Intravenous Bolus).
Associated medications used:
  • Beta Blocker
  • Ace Inhibitor


Erythema, Throat Tightness, Epistaxis, Unresponsive To Stimuli, Seizure Like Phenomena
Adverse event was reported on Mar 22, 2013 by a Male taking Definity (Dosage: 1.5 Definity Diluted With 8.5) was diagnosed with and. Location: US , 22 years of age, weighting 163.0 lb, Patient felt the following Definity side effects: erythema, throat tightness, epistaxis, unresponsive to stimuli, seizure like phenomena.
Multiple prescriptions taken:
  • Famotidine (famotidine)
  • Diphenhydramine (diphenhydramine)
  • Lorazepam (lorazepam)
  • B12 (cyanocobalamin)


Anaphylactic Shock, Atrial Fibrillation, Renal Failure Acute, Burning Sensation, Eye Movement Disorder, Respiratory Arrest
on Mar 13, 2013 Female from US , 87 years of age, weighting 150.0 lb, was diagnosed with and was treated with Definity. After Definity was administered, patient encountered several Definity side effects: anaphylactic shock, atrial fibrillation, renal failure acute, burning sensation, eye movement disorder, respiratory arrest. Definity dosage: Diluted In 8.5 Ml Normal Saline (2 Ml).
Multiple concurrent drugs taken:
  • Acetaminophen (paracetamol)
  • Enalapril
  • Gabapentin (gabapentin)
  • Tramadol (tramadol)
  • Nystatin (nystatin)
  • Senna Docusate (docusate, Senna Alexandrina)
  • Diclofenac (diclofenac)
  • Atenolol (atenolol)
Patient was hospitalized.

Feeling Hot, Pulseless Electrical Activity, Dyspnoea, Post Procedural Complication
on Apr 01, 2013 Female from US , 70 years of age, was diagnosed with and was treated with Definity. Directly after, patient experienced the unwanted or unexpected Definity side effects: feeling hot, pulseless electrical activity, dyspnoea, post procedural complication. Definity dosage: 1 Vial Diluted With Normal Saline (2 Ml).
Associated medications used:
  • Lipitor (atorvastatin Calcium)
  • Lopressor (metoprolol Tartrate)
  • Benadryl(diphenhydramine Hydrochloride)
  • Ativan(lorazepam)
  • Estraderm(estradiol)
  • Zestril(lisinopril)
  • K-dur(potassium Chloride)
  • Zofran(ondansetron)
Patient was hospitalized.

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Why Your Notes are Important

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    Medicine Name and Dosage:

     

    Side Effects

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    Other Medicine(s) or Treatment(s)

     

     

     

     

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    Discuss Definity Side Effects



    Did You Have a Definity Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Definity for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Safety Alerts, Active Ingredients, Usage Information

    Alternative DEFINITY Names:PERFLUTRE

    Active Ingredient: PERFLUTRE

    More About Definity

    Side Effects reported to FDA: 1251

    Definity safety alerts: 2008 2007

    Reported deaths: 42

    Reported hospitalizations: 140

    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]

    Latest Definity clinical trials