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EXTRAVASATION (9)
Infiltration (2)
Hives (1)
Hives And Tongue Swelling (1)
TACHYCARDIA AND HOT FLASH (1)
Tongue Swelling (1)
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Isovue Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 570 

Anaphylactic Reaction (8218573-X)
on Mar 15, 2011 Female from UNITED STATES , 70 years of age, was diagnosed with
  • liver function test abnormal
  • computerised tomogram abdomen
and was treated with Isovue-370. Directly after, patient experienced the unwanted or unexpected Isovue side effects: anaphylactic reaction. Isovue-370 dosage: 100ml Once Intravenous (not Otherwise Specified). Patient was hospitalized.

Hypersensitivity (8218569-8)
Patient was taking Isovue-370. Patient felt the following Isovue side effects: hypersensitivity on Feb 11, 2011 from UNITED STATES Additional patient health information: Female , 55 years of age, was diagnosed with
  • computerised tomogram
and. Isovue-370 dosage: 100ml Once Intravenous (not Otherwise Specified).

Hyperhidrosis, Cold Sweat, Dyspnoea, Tachycardia, Hypertension (8218562-5)
Adverse event was reported on Jan 27, 2011 by a Male taking Isovue-300 (Dosage: 100ml Once Intravenous (not Otherwise Specified)) was diagnosed with
  • computerised tomogram
  • dysphonia
  • mass
and. Location: UNITED STATES , 73 years of age, weighting 158.7 lb, After Isovue was administered, patient encountered several Isovue side effects: hyperhidrosis, cold sweat, dyspnoea, tachycardia, hypertension.

Cardio-respiratory Arrest (8218552-2)
on Jan 21, 2011 Female from UNITED STATES , 88 years of age, was diagnosed with
  • computerised tomogram
  • hepatic haematoma
  • abdominal pain upper
and was treated with Isovue-370. Directly after, patient experienced the unwanted or unexpected Isovue side effects: cardio-respiratory arrest. Isovue-370 dosage: 100ml Once Intravenous (not Otherwise Specified). Patient was hospitalized.


Extravasation, Compartment Syndrome (8218551-0)
on Jun 01, 2011 Female from UNITED STATES , 20 years of age, was diagnosed with
  • neoplasm skin
  • computerised tomogram
and was treated with Isovue-370. Patient felt the following Isovue side effects: extravasation, compartment syndrome. Isovue-370 dosage: 130ml Once Intravenos (not Otherwise Specified).

Maternal Exposure During Pregnancy (8218550-9)
Patient was taking Isovue-300. After Isovue was administered, patient encountered several Isovue side effects: maternal exposure during pregnancy on Jan 24, 2012 from UNITED STATES Additional patient health information: Female , 34 years of age, was diagnosed with
  • computerised tomogram
  • abdominal mass
and. Isovue-300 dosage: 125ml Once Intravenous (not Otherwise Specified).

Anaphylactoid Reaction (8218529-7)
Adverse event was reported on Mar 22, 2011 by a Female taking Isovue-370 (Dosage: 60ml Once, Intra-arterial) was diagnosed with
  • coronary artery disease
  • stent placement
and. Location: UNITED STATES , 85 years of age, weighting 138.9 lb, Directly after, patient experienced the unwanted or unexpected Isovue side effects: anaphylactoid reaction. Patient was hospitalized.

Anaphylactic Reaction, Chest Pain (8218513-3)
on Dec 16, 2011 Female from UNITED STATES , 43 years of age, weighting 180.8 lb, was diagnosed with
  • computerised tomogram
  • migraine
and was treated with Isovue-370. Patient felt the following Isovue side effects: anaphylactic reaction, chest pain. Isovue-370 dosage: 100ml Once Intravenous (not Otherwise Specified). Patient was hospitalized.

Vomiting, Nausea, Aggression, Headache, Memory Impairment, Convulsion (8212853-X)
on Mar 13, 2012 Male from UNITED STATES , 44 years of age, was diagnosed with
  • pain management
  • epidural test dose
and was treated with Isovue-300. After Isovue was administered, patient encountered several Isovue side effects: vomiting, nausea, aggression, headache, memory impairment, convulsion. Isovue-300 dosage: N/A.

Erythema Induratum, Skin Exfoliation, Rash, Oedema (8180987-4)
Patient was taking Isovue-370. Directly after, patient experienced the unwanted or unexpected Isovue side effects: erythema induratum, skin exfoliation, rash, oedema on Mar 01, 2012 from UNITED STATES Additional patient health information: Female , weighting 122.0 lb, was diagnosed with
  • computerised tomogram
and. Isovue-370 dosage: 370 Iv.

Compartment Syndrome, Extravasation (8150754-6)
Adverse event was reported on Jun 01, 2011 by a Female taking Isovue-370 (Dosage: N/A) was diagnosed with
  • computerised tomogram
  • lower extremity mass
and. Location: UNITED STATES , 20 years of age, Patient felt the following Isovue side effects: compartment syndrome, extravasation.

Pneumonia, Hypertension, Respiratory Distress (8142558-5)
on Feb 14, 2012 Female from UNITED STATES , weighting 194.0 lb, was diagnosed with
  • weight decreased
and was treated with Isovue-370. After Isovue was administered, patient encountered several Isovue side effects: pneumonia, hypertension, respiratory distress. Isovue-370 dosage: N/A.
Multiple concurrent drugs taken:
  • Antihypertensives
Patient was hospitalized.

Refusal Of Treatment By Patient, Dysphagia, Injection Site Pruritus (8111584-4)
on Feb 02, 2012 Female from UNITED STATES , 46 years of age, was treated with Isovue-370. Directly after, patient experienced the unwanted or unexpected Isovue side effects: refusal of treatment by patient, dysphagia, injection site pruritus. Isovue-370 dosage: 042. Patient was hospitalized.

Coronary No-reflow Phenomenon (8103364-0)
Patient was taking Isovue-370. Patient felt the following Isovue side effects: coronary no-reflow phenomenon on Jan 31, 2012 from UNITED STATES Additional patient health information: Male , 55 years of age, was diagnosed with
  • chest discomfort
  • arteriogram coronary
and. Isovue-370 dosage: N/A. Patient was hospitalized.

Renal Failure Acute (8095003-2)
Adverse event was reported on Jan 31, 2012 by a Male taking Isovue-300 (Dosage: 100ml) was diagnosed with
  • imaging procedure
and. Location: UNITED STATES , 71 years of age, After Isovue was administered, patient encountered several Isovue side effects: renal failure acute.
Multiple concurrent drugs taken:
  • Lisinopril
  • Toprol-xl
  • Flagyl
  • Ciprofloxacin
Patient was hospitalized.

Hypertension, Respiratory Distress, Pneumonia (8072364-1)
on Jan 23, 2012 Female from UNITED STATES , weighting 194.0 lb, was diagnosed with
  • nausea
  • vomiting
  • weight decreased
and was treated with Isovue-370. Directly after, patient experienced the unwanted or unexpected Isovue side effects: hypertension, respiratory distress, pneumonia. Isovue-370 dosage: N/A. Patient was hospitalized.

Lethargy, Pallor, Unresponsive To Stimuli, Asthenia, Carotid Artery Occlusion, Syncope, Communication Disorder (8048108-6)
on Jan 12, 2012 Female from UNITED STATES , 74 years of age, weighting 159.8 lb, was diagnosed with
  • computerised tomogram
and was treated with Isovue-370. Patient felt the following Isovue side effects: lethargy, pallor, unresponsive to stimuli, asthenia, carotid artery occlusion, syncope, communication disorder. Isovue-370 dosage: 200ml X1 Iv. Patient was hospitalized.

Contrast Media Allergy (8041888-5)
Patient was taking Isovue-300. After Isovue was administered, patient encountered several Isovue side effects: contrast media allergy on Jan 12, 2012 from UNITED STATES Additional patient health information: Female , weighting 134.0 lb, was diagnosed with
  • computerised tomogram
and. Isovue-300 dosage: 100ml.

Contrast Media Reaction (8041864-2)
Adverse event was reported on Jan 12, 2012 by a Male taking Isovue-300 (Dosage: 100ml) was diagnosed with
  • diagnostic procedure
and. Location: UNITED STATES , weighting 191.0 lb, Directly after, patient experienced the unwanted or unexpected Isovue side effects: contrast media reaction.

Hypotension, Ventricular Tachycardia, Erythema, Hypertension, Vomiting, Nausea (7903570-1)
on Nov 09, 2011 Female from UNITED STATES , 66 years of age, was diagnosed with
  • catheterisation cardiac
and was treated with Isovue-370. Patient felt the following Isovue side effects: hypotension, ventricular tachycardia, erythema, hypertension, vomiting, nausea. Isovue-370 dosage: N/A.

Nausea (7903568-3)
on Nov 09, 2011 Female from UNITED STATES , 58 years of age, was diagnosed with
  • catheterisation cardiac
and was treated with Isovue-370. After Isovue was administered, patient encountered several Isovue side effects: nausea. Isovue-370 dosage: N/A.

Erythema (7903543-9)
Patient was taking Isovue-370. Directly after, patient experienced the unwanted or unexpected Isovue side effects: erythema on Nov 09, 2011 from UNITED STATES Additional patient health information: Female , 70 years of age, was diagnosed with
  • catheterisation cardiac
and. Isovue-370 dosage: N/A.

Compartment Syndrome, Extravasation (7902392-5)
Adverse event was reported on Nov 03, 2011 by a Male taking Isovue-300 (Dosage: N/A) was diagnosed with
  • angiogram
and. Location: UNITED STATES , 57 years of age, Patient felt the following Isovue side effects: compartment syndrome, extravasation.

Visual Pathway Disorder, Disorientation (7860165-6)
on Oct 24, 2011 Female from UNITED STATES , 74 years of age, was diagnosed with
  • angioplasty
and was treated with Isovue-370. After Isovue was administered, patient encountered several Isovue side effects: visual pathway disorder, disorientation. Isovue-370 dosage: N/A. Patient was hospitalized.

Contrast Media Reaction, Atrial Fibrillation (7815185-4)
on Oct 11, 2011 Female from AUSTRALIA , weighting 165.3 lb, was diagnosed with
  • computerised tomogram
  • abdominal tenderness
  • abdominal pain upper
and was treated with Isovue-370. Directly after, patient experienced the unwanted or unexpected Isovue side effects: contrast media reaction, atrial fibrillation. Isovue-370 dosage: N/A. Patient was hospitalized.

Showing 1-25 of 570 

Isovue Health Episodes

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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.

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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.

Isovue Information

Alternative ISOVUE Names:IOPAMIDOL

Active Ingredient: IOPAMIDOL

Isovue Dosage, Warnings, Usage.

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

[Posted 11/28/2012]

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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[11/27/12 - Firm Press Release - Bracco Diagnostics]

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