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Isovue Side Effects

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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.

Isovue Side Effects Reported to FDA



Isovue Side Effect Report#9925990
Head Discomfort, Slow Speech, Dizziness, Urticaria, Erythema
This is a report of a 20-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: computerised tomogram, who was treated with Isovue 300 (dosage: Left Antecubital, start time:
Jul 16, 2013), combined with: NA. and developed a serious reaction and side effect(s): Head Discomfort, Slow Speech, Dizziness, Urticaria, Erythema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Isovue 300 treatment in female patients, resulting in Head Discomfort side effect.
Isovue Side Effect Report#9925989
Occupational Exposure To Product, Lip Swelling
This report suggests a potential Isovue Occupational Exposure To Product side effect(s) that can have serious consequences. A 28-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: computerised tomogram and used Isovue (dosage: Occupational Exposure) starting
Nov 18, 2013. After starting Isovue the patient began experiencing various side effects, including: Occupational Exposure To Product, Lip SwellingAdditional drugs used concurrently: NA. Although Isovue demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Occupational Exposure To Product, may still occur.
Isovue Side Effect Report#9925986
Feeling Hot, Head Discomfort, Tinnitus, Dizziness
This Feeling Hot problem was reported by a health professional from US. A 52-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: computerised tomogram abdomen. On
Jul 19, 2013 this consumer started treatment with Isovue 300 (dosage: NA). The following drugs were being taken at the same time: NA. When using Isovue 300, the patient experienced the following unwanted symptoms/side effects: Feeling Hot, Head Discomfort, Tinnitus, DizzinessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Feeling Hot, may become evident only after a product is in use by the general population.
Isovue Side Effect Report#9925983
Chest Discomfort, Dyspnoea, Breath Sounds Abnormal
This Chest Discomfort side effect was reported by a health professional from US. A 32-year-old male patient (weight:NA) experienced the following symptoms/conditions: computerised tomogram abdomen.The patient was prescribed Isovue 300 (drug dosage: NA), which was initiated on
Nov 07, 2013. Concurrently used drugs:
  • Prednisone
  • Prednisone
  • Prednisone
  • Benadryl
.After starting to take Isovue 300 the consumer reported adverse symptoms, such as: Chest Discomfort, Dyspnoea, Breath Sounds AbnormalThese side effects may potentially be related to Isovue 300.
Isovue Side Effect Report#9925979
Amnesia, Paraesthesia Oral, Loss Of Consciousness, Hypoaesthesia, Chest Discomfort
This is a report of a 40-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: computerised tomogram head, who was treated with Isovue 370 (dosage: NA, start time:
Sep 20, 2013), combined with: NA. and developed a serious reaction and side effect(s): Amnesia, Paraesthesia Oral, Loss Of Consciousness, Hypoaesthesia, Chest Discomfort after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Isovue 370 treatment in female patients, resulting in Amnesia side effect.
Isovue Side Effect Report#9925976
Local Swelling
This report suggests a potential Isovue 300 Local Swelling side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: computerised tomogram thorax and used Isovue 300 (dosage: NA) starting
Aug 14, 2013. After starting Isovue 300 the patient began experiencing various side effects, including: Local SwellingAdditional drugs used concurrently: NA. Although Isovue 300 demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Local Swelling, may still occur.
Isovue Side Effect Report#9925969
Dysphagia
This Dysphagia problem was reported by a health professional from US. A 75-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: computerised tomogram. On
Jun 24, 2013 this consumer started treatment with Isovue 300 (dosage: 2 Ml/s). The following drugs were being taken at the same time:
  • Allopurinol
  • Tamsulosin
  • Atorvastatin
  • Amitriptyline
  • Alendronate
  • Stool Softener
  • Metoprolol
  • Plavix
When using Isovue 300, the patient experienced the following unwanted symptoms/side effects: DysphagiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dysphagia, may become evident only after a product is in use by the general population.
Isovue Side Effect Report#9925963
Occupational Exposure To Product, Lip Swelling
This Occupational Exposure To Product side effect was reported by a health professional from US. A 49-year-old female patient (weight:NA) experienced the following symptoms/conditions: computerised tomogram.The patient was prescribed Isovue (drug dosage: Occupational Exposure), which was initiated on
Dec 16, 2013. Concurrently used drugs: NA..After starting to take Isovue the consumer reported adverse symptoms, such as: Occupational Exposure To Product, Lip SwellingThese side effects may potentially be related to Isovue.
Isovue Side Effect Report#9925958
Tremor, Respiratory Rate Increased
This is a report of a 56-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: computerised tomogram abdomen, who was treated with Isovue 370 (dosage: NA, start time:
Jun 21, 2013), combined with:
  • Ambien
  • Astelin
  • Nasal Preparations
  • Estrace
and developed a serious reaction and side effect(s): Tremor, Respiratory Rate Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Isovue 370 treatment in female patients, resulting in Tremor side effect.
Isovue Side Effect Report#9925946
Contusion, Pruritus, Urticaria, Erythema
This report suggests a potential Isovue 370 Contusion side effect(s) that can have serious consequences. A 52-year-old patient (weight: NA) from US was diagnosed with the following symptoms/conditions: computerised tomogram and used Isovue 370 (dosage: NA) starting
Jan 25, 2013. After starting Isovue 370 the patient began experiencing various side effects, including: Contusion, Pruritus, Urticaria, ErythemaAdditional drugs used concurrently: NA. Although Isovue 370 demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Contusion, may still occur.
Isovue Side Effect Report#9925262
Convulsion
This Convulsion problem was reported by a health professional from US. A 50-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: angiogram. On
Dec 14, 2013 this consumer started treatment with Isovue 370 (dosage: NA). The following drugs were being taken at the same time: NA. When using Isovue 370, the patient experienced the following unwanted symptoms/side effects: ConvulsionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Convulsion, may become evident only after a product is in use by the general population.
Isovue Side Effect Report#9925261
Anaphylactic Reaction
This Anaphylactic Reaction side effect was reported by a health professional from US. A 88-year-old male patient (weight:NA) experienced the following symptoms/conditions: computerised tomogram.The patient was prescribed Isovue 300 (drug dosage: NA), which was initiated on
Nov 06, 2013. Concurrently used drugs: NA..After starting to take Isovue 300 the consumer reported adverse symptoms, such as: Anaphylactic ReactionThese side effects may potentially be related to Isovue 300.
Isovue Side Effect Report#9925259
Anaphylactoid Shock
This is a report of a 64-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: computerised tomogram, who was treated with Isovue 370 (dosage: NA, start time:
Oct 18, 2013), combined with: NA. and developed a serious reaction and side effect(s): Anaphylactoid Shock after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Isovue 370 treatment in male patients, resulting in Anaphylactoid Shock side effect. The patient was hospitalized.
Isovue Side Effect Report#9925257
Chest Pain, Vomiting
This report suggests a potential Isovue 300 Chest Pain side effect(s) that can have serious consequences. A 78-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: computerised tomogram and used Isovue 300 (dosage: NA) starting
Oct 18, 2013. After starting Isovue 300 the patient began experiencing various side effects, including: Chest Pain, VomitingAdditional drugs used concurrently: NA.The patient was hospitalized. Although Isovue 300 demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Chest Pain, may still occur.
Isovue Side Effect Report#9925255
Hypersensitivity
This Hypersensitivity problem was reported by a health professional from US. A 69-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: angiogram. On
Oct 02, 2013 this consumer started treatment with Isovue (dosage: NA). The following drugs were being taken at the same time:
  • Antacid
  • Iron
  • Crestor
When using Isovue, the patient experienced the following unwanted symptoms/side effects: HypersensitivityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypersensitivity, may become evident only after a product is in use by the general population.
Isovue Side Effect Report#9925254
Hypersensitivity
This Hypersensitivity side effect was reported by a health professional from US. A 66-year-old male patient (weight:NA) experienced the following symptoms/conditions: computerised tomogram.The patient was prescribed Isovue (drug dosage: NA), which was initiated on
Aug 15, 2013. Concurrently used drugs: NA..After starting to take Isovue the consumer reported adverse symptoms, such as: HypersensitivityThese side effects may potentially be related to Isovue.
Isovue Side Effect Report#9925253
Dyspnoea, Chest Discomfort
This is a report of a 21-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: computerised tomogram, who was treated with Isovue 300 (dosage: NA, start time:
Jul 31, 2013), combined with:
  • Medrol (2 Hours Prior To Ct)
and developed a serious reaction and side effect(s): Dyspnoea, Chest Discomfort after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Isovue 300 treatment in female patients, resulting in Dyspnoea side effect.
Isovue Side Effect Report#9925252
Hypersensitivity
This report suggests a potential Isovue 370 Hypersensitivity side effect(s) that can have serious consequences. A 47-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: computerised tomogram and used Isovue 370 (dosage: NA) starting
Jun 18, 2013. After starting Isovue 370 the patient began experiencing various side effects, including: HypersensitivityAdditional drugs used concurrently: NA. Although Isovue 370 demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypersensitivity, may still occur.
Isovue Side Effect Report#9925251
Hypotension
This Hypotension problem was reported by a health professional from US. A 74-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: catheterisation cardiac. On
Aug 26, 2013 this consumer started treatment with Isovue 370 (dosage: NA). The following drugs were being taken at the same time:
  • Benadryl
  • Protonix
  • Plavix
  • Solu-medrol
  • Adalat
  • Hydralazine
  • Pepcid
  • Zetia
When using Isovue 370, the patient experienced the following unwanted symptoms/side effects: HypotensionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypotension, may become evident only after a product is in use by the general population.
Isovue Side Effect Report#9925250
Anaphylactic Reaction
This Anaphylactic Reaction side effect was reported by a health professional from US. A 53-year-old female patient (weight:NA) experienced the following symptoms/conditions: computerised tomogram abdomen.The patient was prescribed Isovue (drug dosage: NA), which was initiated on
Jun 03, 2013. Concurrently used drugs: NA..After starting to take Isovue the consumer reported adverse symptoms, such as: Anaphylactic ReactionThese side effects may potentially be related to Isovue.
Isovue Side Effect Report#9925248
Urticaria, Eye Swelling, Erythema, Feeling Hot
This is a report of a 53-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: computerised tomogram head, who was treated with Isovue 300 (dosage: NA, start time:
Jul 03, 2013), combined with:
  • Pravastatin
and developed a serious reaction and side effect(s): Urticaria, Eye Swelling, Erythema, Feeling Hot after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Isovue 300 treatment in male patients, resulting in Urticaria side effect.
Isovue Side Effect Report#9925246
Throat Tightness
This report suggests a potential Isovue 370 Throat Tightness side effect(s) that can have serious consequences. A 55-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: computerised tomogram and used Isovue 370 (dosage: NA) starting
May 24, 2013. After starting Isovue 370 the patient began experiencing various side effects, including: Throat TightnessAdditional drugs used concurrently:
  • Prednisone (12 Hours Prior To Procedure)
  • Prednisone (2 Hours Prior To Procedure)
Although Isovue 370 demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Throat Tightness, may still occur.
Isovue Side Effect Report#9925245
Anaphylactic Reaction
This Anaphylactic Reaction problem was reported by a health professional from US. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: computerised tomogram abdomen. On
Jul 01, 2013 this consumer started treatment with Isovue (dosage: NA). The following drugs were being taken at the same time: NA. When using Isovue, the patient experienced the following unwanted symptoms/side effects: Anaphylactic ReactionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anaphylactic Reaction, may become evident only after a product is in use by the general population.
Isovue Side Effect Report#9925233
Hypersensitivity
This Hypersensitivity side effect was reported by a health professional from US. A 46-year-old female patient (weight:NA) experienced the following symptoms/conditions: computerised tomogram.The patient was prescribed Isovue 370 (drug dosage: NA), which was initiated on
Mar 07, 2013. Concurrently used drugs: NA..After starting to take Isovue 370 the consumer reported adverse symptoms, such as: HypersensitivityThese side effects may potentially be related to Isovue 370.
Isovue Side Effect Report#9925232
Hypersensitivity
This is a report of a 64-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: computerised tomogram, who was treated with Isovue (dosage: NA, start time:
Feb 12, 2013), combined with: NA. and developed a serious reaction and side effect(s): Hypersensitivity after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Isovue treatment in female patients, resulting in Hypersensitivity side effect.


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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.

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What are common Isovue Side Effects for Women?

Women Side EffectsReports
Hypersensitivity 59
Urticaria 50
Dyspnoea 47
Pruritus 37
Contrast Media Reaction 29
Anaphylactoid Reaction 28
Anaphylactic Reaction 23
Vomiting 21
Nausea 19
Sneezing 18

What are common Isovue Side Effects for Men?

Men Side EffectsReports
Urticaria 31
Hypersensitivity 30
Dyspnoea 22
Anaphylactic Reaction 18
Anaphylactic Shock 15
Anaphylactoid Reaction 15
Hypotension 15
Convulsion 14
Pruritus 13
Contrast Media Reaction 12

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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 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.

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    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

    Isovue Safety Alerts, Active Ingredients, Usage Information

    NDC0270-1314
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameISOVUE 200
    NameIOPAMIDOL
    Dosage FormINJECTION, SOLUTION
    RouteINTRAVASCULAR
    On market since19941012
    LabelerBRACCO DIAGNOSTICS INC
    Active Ingredient(s)IOPAMIDOL
    Strength(s)408
    Unit(s)mg/mL
    Pharma ClassRadiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]

    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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