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Isovue Side Effects

Common Isovue Side Effects

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

Hypersensitivity (89)
Urticaria (82)
Dyspnoea (69)
Pruritus (51)
Anaphylactoid Reaction (43)
Anaphylactic Reaction (41)
Contrast Media Reaction (41)
Vomiting (30)
Nausea (28)
Anaphylactic Shock (28)
Sneezing (24)
Throat Tightness (24)
Hypotension (23)
Cardio-respiratory Arrest (22)
Chest Discomfort (20)
Chest Pain (20)
Erythema (20)
Cough (20)
Flushing (19)
Convulsion (19)

➢ 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.

Isovue Side Effects Reported to FDA

The following Isovue 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 Isovue 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.
Head Discomfort, Slow Speech, Dizziness, Urticaria, Erythema
on Feb 26, 2014 Female from US , 20 years of age, was diagnosed with and was treated with Isovue 300. Directly after, patient experienced the unwanted or unexpected Isovue side effects: head discomfort, slow speech, dizziness, urticaria, erythema. Isovue 300 dosage: Left Antecubital.

Occupational Exposure To Product, Lip Swelling
Patient was taking Isovue. Patient felt the following Isovue side effects: occupational exposure to product, lip swelling on Feb 26, 2014 from US Additional patient health information: Female , 28 years of age, was diagnosed with and. Isovue dosage: Occupational Exposure.

Feeling Hot, Head Discomfort, Tinnitus, Dizziness
Adverse event was reported on Feb 26, 2014 by a Female taking Isovue 300 (Dosage: N/A) was diagnosed with and. Location: US , 52 years of age, After Isovue was administered, patient encountered several Isovue side effects: feeling hot, head discomfort, tinnitus, dizziness.

Chest Discomfort, Dyspnoea, Breath Sounds Abnormal
on Feb 26, 2014 Male from US , 32 years of age, was diagnosed with and was treated with Isovue 300. Directly after, patient experienced the unwanted or unexpected Isovue side effects: chest discomfort, dyspnoea, breath sounds abnormal. Isovue 300 dosage: N/A.
Associated medications used:
  • Prednisone
  • Prednisone
  • Prednisone
  • Benadryl



Amnesia, Paraesthesia Oral, Loss Of Consciousness, Hypoaesthesia, Chest Discomfort
on Feb 26, 2014 Female from US , 40 years of age, was diagnosed with and was treated with Isovue 370. Patient felt the following Isovue side effects: amnesia, paraesthesia oral, loss of consciousness, hypoaesthesia, chest discomfort. Isovue 370 dosage: N/A.

Local Swelling
Patient was taking Isovue 300. After Isovue was administered, patient encountered several Isovue side effects: local swelling on Feb 26, 2014 from US Additional patient health information: Female , 67 years of age, weighting 200.6 lb, was diagnosed with and. Isovue 300 dosage: N/A.

Dysphagia
Adverse event was reported on Feb 26, 2014 by a Male taking Isovue 300 (Dosage: 2 Ml/s) was diagnosed with and. Location: US , 75 years of age, weighting 224.9 lb, Directly after, patient experienced the unwanted or unexpected Isovue side effects: dysphagia.
Associated medications used:
  • Allopurinol
  • Tamsulosin
  • Atorvastatin
  • Amitriptyline
  • Alendronate
  • Stool Softener
  • Metoprolol
  • Plavix


Occupational Exposure To Product, Lip Swelling
on Feb 26, 2014 Female from US , 49 years of age, was diagnosed with and was treated with Isovue. Patient felt the following Isovue side effects: occupational exposure to product, lip swelling. Isovue dosage: Occupational Exposure.

Tremor, Respiratory Rate Increased
on Feb 26, 2014 Female from US , 56 years of age, was diagnosed with and was treated with Isovue 370. After Isovue was administered, patient encountered several Isovue side effects: tremor, respiratory rate increased. Isovue 370 dosage: N/A.
Multiple concurrent drugs taken:
  • Ambien
  • Astelin
  • Nasal Preparations
  • Estrace


Contusion, Pruritus, Urticaria, Erythema
Patient was taking Isovue 370. Directly after, patient experienced the unwanted or unexpected Isovue side effects: contusion, pruritus, urticaria, erythema on Feb 26, 2014 from US Additional patient health information: Patient , 52 years of age, was diagnosed with and. Isovue 370 dosage: N/A.

Convulsion
Adverse event was reported on Feb 26, 2014 by a Female taking Isovue 370 (Dosage: N/A) was diagnosed with and. Location: US , 50 years of age, Patient felt the following Isovue side effects: convulsion.

Anaphylactic Reaction
on Feb 26, 2014 Male from US , 88 years of age, was diagnosed with and was treated with Isovue 300. After Isovue was administered, patient encountered several Isovue side effects: anaphylactic reaction. Isovue 300 dosage: N/A.

Anaphylactoid Shock
on Feb 26, 2014 Male from US , 64 years of age, was diagnosed with and was treated with Isovue 370. Directly after, patient experienced the unwanted or unexpected Isovue side effects: anaphylactoid shock. Isovue 370 dosage: N/A. Patient was hospitalized.

Chest Pain, Vomiting
Patient was taking Isovue 300. Patient felt the following Isovue side effects: chest pain, vomiting on Feb 26, 2014 from US Additional patient health information: Female , 78 years of age, was diagnosed with and. Isovue 300 dosage: N/A. Patient was hospitalized.

Hypersensitivity
Adverse event was reported on Feb 26, 2014 by a Male taking Isovue (Dosage: N/A) was diagnosed with and. Location: US , 69 years of age, After Isovue was administered, patient encountered several Isovue side effects: hypersensitivity.
Multiple concurrent drugs taken:
  • Antacid
  • Iron
  • Crestor


Hypersensitivity
on Feb 26, 2014 Male from US , 66 years of age, was diagnosed with and was treated with Isovue. Directly after, patient experienced the unwanted or unexpected Isovue side effects: hypersensitivity. Isovue dosage: N/A.

Dyspnoea, Chest Discomfort
on Feb 26, 2014 Female from US , 21 years of age, weighting 169.8 lb, was diagnosed with and was treated with Isovue 300. Patient felt the following Isovue side effects: dyspnoea, chest discomfort. Isovue 300 dosage: N/A.
Multiple prescriptions taken:
  • Medrol (2 Hours Prior To Ct)


Hypersensitivity
Patient was taking Isovue 370. After Isovue was administered, patient encountered several Isovue side effects: hypersensitivity on Feb 26, 2014 from US Additional patient health information: Female , 47 years of age, was diagnosed with and. Isovue 370 dosage: N/A.

Hypotension
Adverse event was reported on Feb 26, 2014 by a Male taking Isovue 370 (Dosage: N/A) was diagnosed with and. Location: US , 74 years of age, weighting 176.4 lb, Directly after, patient experienced the unwanted or unexpected Isovue side effects: hypotension.
Associated medications used:
  • Benadryl
  • Protonix
  • Plavix
  • Solu-medrol
  • Adalat
  • Hydralazine
  • Pepcid
  • Zetia


Anaphylactic Reaction
on Feb 26, 2014 Female from US , 53 years of age, was diagnosed with and was treated with Isovue. Patient felt the following Isovue side effects: anaphylactic reaction. Isovue dosage: N/A.

Urticaria, Eye Swelling, Erythema, Feeling Hot
on Feb 26, 2014 Male from US , 53 years of age, weighting 227.1 lb, was diagnosed with and was treated with Isovue 300. After Isovue was administered, patient encountered several Isovue side effects: urticaria, eye swelling, erythema, feeling hot. Isovue 300 dosage: N/A.
Multiple concurrent drugs taken:
  • Pravastatin


Throat Tightness
Patient was taking Isovue 370. Directly after, patient experienced the unwanted or unexpected Isovue side effects: throat tightness on Feb 26, 2014 from US Additional patient health information: Female , 55 years of age, weighting 94.80 lb, was diagnosed with and. Isovue 370 dosage: N/A.
Associated medications used:
  • Prednisone (12 Hours Prior To Procedure)
  • Prednisone (2 Hours Prior To Procedure)


Anaphylactic Reaction
Adverse event was reported on Feb 26, 2014 by a Female taking Isovue (Dosage: N/A) was diagnosed with and. Location: US , 57 years of age, Patient felt the following Isovue side effects: anaphylactic reaction.

Hypersensitivity
on Feb 26, 2014 Female from US , 46 years of age, weighting 143.3 lb, was diagnosed with and was treated with Isovue 370. After Isovue was administered, patient encountered several Isovue side effects: hypersensitivity. Isovue 370 dosage: N/A.

Hypersensitivity
on Feb 26, 2014 Female from US , 64 years of age, was diagnosed with and was treated with Isovue. Directly after, patient experienced the unwanted or unexpected Isovue side effects: hypersensitivity. Isovue dosage: N/A.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

    Discuss Isovue Side Effects

    Did You Have a Isovue Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Isovue for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Safety Alerts, Active Ingredients, Usage Information

    Alternative ISOVUE Names:IOPAMIDOL

    Active Ingredient: IOPAMIDOL

    Isovue Dosage, Warnings, Usage.

    Side Effects reported to FDA: 659

    Isovue safety alerts: 2012

    Reported deaths: 32

    Reported hospitalizations: 82

    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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