Note: This document contains side effect information about perflutren. Some dosage forms listed on this page may not apply to the brand name Definity.
Applies to perflutren: intravenous suspension.
Warning
Intravenous route (Suspension)
Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration with the most serious reactions occurring within 30 minutes of administration. Assess all patients for any condition that precludes use of this product. Always have resuscitation equipment and trained personnel available.
Serious side effects of Definity
Along with its needed effects, perflutren (the active ingredient contained in Definity) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking perflutren:
Less common
- Chest pain
- feeling of warmth
- fever or chills
- redness of the face, neck, arms, and occasionally, upper chest
- trouble breathing
Rare
- Hives or welts, itching, or skin rash
- fast, irregular, pounding, or racing heartbeat or pulse
- redness of the skin
Incidence not known
- Blurred vision
- chest discomfort or tightness
- cold, clammy skin
- confusion
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fainting
- fast, pounding, or irregular heartbeat or pulse
- fast, weak pulse
- feeling of warmth
- headache
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness, dizziness, or fainting
- nervousness
- no blood pressure or pulse
- noisy breathing
- pounding in the ears
- redness of the face, neck, arms, and occasionally, upper chest
- seizures
- stopping of heart
- sweating
- trouble swallowing
- unconsciousness
- unusual tiredness or weakness
Other side effects of Definity
Some side effects of perflutren may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Bad, unusual, or unpleasant (after) taste
- change in taste
- cough
- discomfort at the injection site
- nausea or vomiting
- sore throat
- stuffy or runny nose
Rare
- Back pain
- body or muscle aches
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in color vision
- continuing ringing or buzzing or other unexplained noise in the ears
- difficulty with moving
- difficulty seeing at night
- discoloration of the skin at the injection site
- dry mouth
- hearing loss
- increased sensitivity of the eyes to sunlight
- muscle pain or stiffness
For Healthcare Professionals
Applies to perflutren: intravenous suspension.
General
The most frequently reported adverse reactions were headache, nausea and/or vomiting, warm sensation or flushing, dizziness, and back pain.[Ref]
Cardiovascular
Serious but uncommon cardiopulmonary reactions, including fatalities, have been reported during or following administration of this medication. Most serious reactions occurred within 30 minutes of administration.
QTc prolongation of greater than 30 milliseconds occurred in 29% (64/221) of patients evaluated. Of these patients 72% (46/64) were further evaluated and 39% (18/46) were found to have cardiac rhythm changes. (Definity(R))[Ref]
Common (1% to 10%): Chest pain
Uncommon (0.1% to 1%): Abnormal ECGs, bradycardia, tachycardia, palpitation, hypertension, hypotension
Postmarketing reports: Fatal cardiac arrest, shock, syncope, symptomatic arrhythmias (atrial fibrillation, tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation/tachycardia), hypertension, hypotension[Ref]
Dermatologic
Common (1% to 10%): Flushing
Uncommon (0.1% to 1%): Pruritus, rash, erythematous rash, urticaria, increased sweating, dry skin[Ref]
Gastrointestinal
Common (1% to 10%): Nausea
Uncommon (0.1% to 1%): Dyspepsia, dry mouth, tongue disorder, abdominal pain, diarrhea, vomiting[Ref]
Musculoskeletal
Common (1% to 10%): Back pain
Uncommon (0.1% to 1%): Arthralgia[Ref]
Nervous system
Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Leg cramps, hypertonia, vertigo, paresthesia, dizziness, taste perversion
Postmarketing Reports: Coma, loss of consciousness, convulsion, seizure, transient ischemic attack, agitation, tremor, vision blurred, dizziness, headache, fatigue[Ref]
Renal
Common (1% to 10%): Renal pain[Ref]
Genitourinary
Uncommon (0.1% to 1%): Albuminuria[Ref]
Hematologic
Uncommon (0.1% to 1%): Granulocytosis, leukocytosis, leukopenia, eosinophilia, hematoma[Ref]
Local
Uncommon (0.1% to 1%): Injection site reaction[Ref]
Ocular
Uncommon (0.1% to 1%): Conjunctivitis, abnormal vision[Ref]
Other
Uncommon (0.1% to 1%): Decreased hearing[Ref]
Respiratory
Uncommon (0.1% to 1%): Coughing, hypoxia, pharyngitis, rhinitis, dyspnea
Postmarketing reports: Fatal respiratory arrest, dyspnea, hypoxia, respiratory distress, stridor, wheezing[Ref]
Hypersensitivity
Postmarketing reports: Anaphylactic/anaphylactoid reactions[Ref]
Postmarketing reports of anaphylactic/anaphylactoid reactions have included: anaphylactic shock, hypersensitivity, bronchospasm, throat tightness, angioedema, edema (pharyngeal, palatal, mouth, peripheral, localized), swelling (face, eye, lip, tongue, upper airway), facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema.[Ref]
