Isovue Side Effects
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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.
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.
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Alternative ISOVUE Names:IOPAMIDOL
Active Ingredient: IOPAMIDOL
Side Effects reported to FDA: 570. View Isovue Adverse Reports
Isovue safety alerts: 2012
Reported deaths: 26
Reported hospitalizations: 68
Isovue (iopamidol injection) Pre-Filled Power Injector Syringes by Bracco Diagnostics Inc.: Recall - Presence of Particulates
AUDIENCE: Risk Manager, Cardiology
ISSUE: Bracco Diagnostics Inc. (BDI) is voluntarily initiating a Class I recall of nine (9) lots of Isovue (iopamidol injection) Pre-Filled Power Injector Syringes (Isovue PFS, to be used in combination with Stellant CT Injection Systems) due to the presence of visible particles in syringes observed at the end of standard stability studies on retained samples.These products were distributed to wholesalers and distributors nationwide. BDI has received no reports of adverse events or customer complaints associated with these lots. However, it should be noted that the visible particles in the lots subject to this recall have the potential to cause adverse health consequences. The dates for distribution of the nine (9) affected lots were from January 21, 2010 through May 9, 2012. For a list of products affected see the Firm Press Release.
BACKGROUND: Isovue is indicated for angiography throughout the cardiovascular system, and arterial injection of Isovue (for cerebral angiography) with particulate matter formation could cause stroke.
Isovue PFS is a single use item, administered for diagnostic imaging under medical supervision. The product is packaged in single dose Prefilled Syringe (PFS) presentations of Isovue - 300 FLS2 and Isovue - 370 FLS2.
RECOMMENDATION: Hospitals, Emergency Rooms, Clinics, Physician Offices and other healthcare facilities and providers should not use these lots of Isovue PFS and should immediately quarantine product and contact Stericycle, Bracco’s contractor for handling the recall, at 1-866-201-9133 to arrange for return of the product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
[11/27/12 - Firm Press Release - Bracco Diagnostics]
Isovue Adverse Reactions
Hypersensitivity ( 75 Reports)|Urticaria ( 69 Reports)|Dyspnoea ( 61 Reports)|Pruritus ( 49 Reports)|Anaphylactoid Reaction ( 41 Reports)|Contrast Media Reaction ( 38 Reports)|Anaphylactic Reaction ( 32 Reports)|Vomiting ( 28 Reports)|Anaphylactic Shock ( 27 Reports)|Nausea ( 25 Reports)|Throat Tightness ( 23 Reports)|Sneezing ( 22 Reports)|Cardio-respiratory Arrest ( 19 Reports)|Chest Pain ( 19 Reports)|Flushing ( 18 Reports)|Headache ( 17 Reports)|Hypotension ( 17 Reports)|Chest Discomfort ( 16 Reports)|Convulsion ( 16 Reports)|Cough ( 16 Reports)|Extravasation ( 16 Reports)|Nephropathy Toxic ( 16 Reports)|Erythema ( 15 Reports)|Procedural Complication ( 14 Reports)|Cardiac Arrest ( 13 Reports)|Loss Of Consciousness ( 13 Reports)|Swelling Face ( 13 Reports)|Blood Pressure Decreased ( 12 Reports)|Feeling Hot ( 12 Reports)|Renal Failure ( 12 Reports)|