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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
This is a report of a 20-year-old female patient (weight: NA) from US, suffering from the following 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). The consumer presented with:
  • Head Discomfort
  • Slow Speech
  • Dizziness
  • Urticaria
  • Erythema
which developed 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.

Occupational Exposure To Product, Lip Swelling
This report suggests a potential Isovue Occupational Exposure To Product, Lip Swelling 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. Soon after starting Isovue the patient began experiencing various side effects, including:
  • Occupational Exposure To Product
  • Lip Swelling
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.

Feeling Hot, Head Discomfort, Tinnitus, Dizziness
This Feeling Hot, Head Discomfort, Tinnitus, Dizziness 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 commencing Isovue 300, the patient experienced the following unwanted symptoms/side effects:
  • Feeling Hot
  • Head Discomfort
  • Tinnitus
  • Dizziness
Although 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.

Chest Discomfort, Dyspnoea, Breath Sounds Abnormal
This is a report of a 32-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: computerised tomogram abdomen and was treated with Isovue 300 (dosage: NA) starting Nov 07, 2013. Concurrently used drugs:
  • Prednisone
  • Prednisone
  • Prednisone
  • Benadryl
Soon after that, the consumer experienced the following side effects:
  • Chest Discomfort
  • Dyspnoea
  • Breath Sounds Abnormal
This opens a possibility that Isovue 300 treatment could cause the above reactions, including chest discomfort, and some male subjects may be more susceptible.


Amnesia, Paraesthesia Oral, Loss Of Consciousness, Hypoaesthesia, Chest Discomfort
A 40-year-old female patient (weight: NA) from US with the following symptoms/conditions: computerised tomogram head started Isovue 370 treatment (dosage: NA) on Sep 20, 2013. Soon after starting Isovue 370 treatment, the subject experienced various side effects, including:
  • Amnesia
  • Paraesthesia Oral
  • Loss Of Consciousness
  • Hypoaesthesia
  • Chest Discomfort
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Isovue 370.

Local Swelling
A 67-year-old female patient from US (weight: NA) experienced symptoms, such as: computerised tomogram thorax and was treated with Isovue 300(dosage: NA). The treatment was initiated on Aug 14, 2013. After that a consumer reported the following side effect(s):
  • Local Swelling
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Isovue 300 efficacy: NA.

Dysphagia
In this report, Isovue 300 was administered for the following condition: computerised tomogram.A 75-year-old male consumer from US (weight: NA) started Isovue 300 treatment (dosage: 2 Ml/s) on Jun 24, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Dysphagia
A possible interaction with other drugs could have contributed to this reaction:
  • Allopurinol
  • Tamsulosin
  • Atorvastatin
  • Amitriptyline
  • Alendronate
  • Stool Softener
  • Metoprolol
  • Plavix
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Isovue 300 treatment could be related to the listed above side effect(s).

Occupational Exposure To Product, Lip Swelling
This is a report of the following Isovue side effect(s):
  • Occupational Exposure To Product
  • Lip Swelling
A 49-year-old female patient from US (weight: NA) presented with the following condition: computerised tomogram and received a treatment with Isovue (dosage: Occupational Exposure) starting: Dec 16, 2013.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Isovue treatment could be associated with the listed above side effect(s).

Tremor, Respiratory Rate Increased
This Isovue 370 report was submitted by a 56-year-old female consumer from US (weight: NA). The patient was diagnosed with: computerised tomogram abdomen and Isovue 370 was administered (dosage: NA) starting: Jun 21, 2013. The consumer developed a set of symptoms:
  • Tremor
  • Respiratory Rate Increased
Other drugs used simultaneously:
  • Ambien
  • Astelin
  • Nasal Preparations
  • Estrace
Those unexpected symptoms could be linked to a Isovue 370 treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Contusion, Pruritus, Urticaria, Erythema
This is a report of a possible correlation between Isovue 370 use and the following symptoms/side effect(s):
  • Contusion
  • Pruritus
  • Urticaria
  • Erythema
which could contribute to an assessment of Isovue 370 risk profile.A 52-year-old consumer from US (weight: NA) was suffering from computerised tomogram and was treated with Isovue 370 (dosage: NA) starting Jan 25, 2013.Other concurrent medications: NA.

Convulsion
A 50-year-old female patient from US (weight: NA) presented with the following symptoms: angiogram and after a treatment with Isovue 370 (dosage: NA) experienced the following side effect(s):
  • Convulsion
The treatment was started on Dec 14, 2013. Isovue 370 was used in combination with the following drugs: NA.This report could alert potential Isovue 370 consumers.

Anaphylactic Reaction
In this report, a 88-year-old male patient from US (weight: NA) was affected by a possible Isovue 300 side effect.The patient was diagnosed with computerised tomogram. After a treatment with Isovue 300 (dosage: NA, start date: Nov 06, 2013), the patient experienced the following side effect(s):
  • Anaphylactic Reaction
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Isovue 300 treatment.

Anaphylactoid Shock
This is a report of a 64-year-old male patient from US (weight: NA), who used Isovue 370 (dosage: NA) for a treatment of computerised tomogram. After starting a treatment on Oct 18, 2013, the patient experienced the following side effect(s):
  • Anaphylactoid Shock
The following drugs could possibly have interacted with the Isovue 370 treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Isovue 370 treatment could be related to side effect(s), such as Anaphylactoid Shock.

Chest Pain, Vomiting
This chest pain side effect was reported by a health professional from US. A 78-year-old female patient (weight:NA) experienced the following symptoms/conditions: computerised tomogram. The patient was prescribed Isovue 300 (dosage: NA), which was started on Oct 18, 2013. Concurrently used drugs: NA. When starting to take Isovue 300 the consumer reported the following symptoms:
  • Chest Pain
  • Vomiting
The patient was hospitalized. These side effects may potentially be related to Isovue 300.

Hypersensitivity
This is a Isovue side effect report of a 69-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: angiogram, who was treated with Isovue (dosage:NA, start time: Oct 02, 2013), combined with:
  • Antacid
  • Iron
  • Crestor
, and developed a serious reaction and a hypersensitivity side effect. The patient presented with:
  • Hypersensitivity
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Isovue treatment in male patients suffering from angiogram, resulting in hypersensitivity.

Hypersensitivity
This report suggests a potential Isovue hypersensitivity side effect(s) that can have serious consequences. A 66-year-old male patient from US (weight:NA) was diagnosed with the following health condition(s): computerised tomogram and used Isovue (dosage: NA) starting Aug 15, 2013. Soon after starting Isovue the patient began experiencing various side effects, including:
  • Hypersensitivity
Drugs used concurrently:NA. Although Isovue demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as hypersensitivity, may still occur.

Dyspnoea, Chest Discomfort
This dyspnoea problem was reported by a health professional from US. A 21-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): computerised tomogram.On Jul 31, 2013 a consumer started treatment with Isovue 300 (dosage: NA). The following drugs/medications were being taken at the same time:
  • Medrol (2 Hours Prior To Ct)
When commencing Isovue 300, the patient experienced the following unwanted symptoms /side effects:
  • Dyspnoea
  • Chest Discomfort
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as dyspnoea, may become evident only after a product is in use by the general population.

Hypersensitivity
This is a Isovue 370 side effect report of a 47-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: computerised tomogram and was treated with Isovue 370 (dosage: NA) starting Jun 18, 2013. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Hypersensitivity
This opens a possibility that Isovue 370 could cause hypersensitivity and that some female patients may be more susceptible.

Hypotension
A 74-year-old male patient (weight: NA) from US with the following symptoms: catheterisation cardiac started Isovue 370 treatment (dosage: NA) on Aug 26, 2013. Soon after starting Isovue 370 treatment, the consumer experienced several side effects, including:
  • Hypotension
. Concurrently used drugs:
  • Benadryl
  • Protonix
  • Plavix
  • Solu-medrol
  • Adalat
  • Hydralazine
  • Pepcid
  • Zetia
This finding indicates that some patients can be more vulnerable to developing Isovue 370 side effects, such as hypotension.

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 (dosage: NA), which was started on Jun 03, 2013. Concurrently used drugs: NA..When starting to take Isovue the consumer reported symptoms, such as:
  • Anaphylactic Reaction
These side effects may potentially be related to Isovue.

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 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). The consumer presented with:
  • Urticaria
  • Eye Swelling
  • Erythema
  • Feeling Hot
which developed 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.

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. Soon after starting Isovue 370 the patient began experiencing various side effects, including:
  • Throat Tightness
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.

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 commencing Isovue, the patient experienced the following unwanted symptoms/side effects:
  • Anaphylactic Reaction
Although 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.

Hypersensitivity
This is a report of a 46-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: computerised tomogram and was treated with Isovue 370 (dosage: NA) starting Mar 07, 2013. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Hypersensitivity
This opens a possibility that Isovue 370 treatment could cause the above reactions, including hypersensitivity, and some female subjects may be more susceptible.

Hypersensitivity
A 64-year-old female patient (weight: NA) from US with the following symptoms/conditions: computerised tomogram started Isovue treatment (dosage: NA) on Feb 12, 2013. Soon after starting Isovue treatment, the subject experienced various side effects, including:
  • Hypersensitivity
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Isovue.

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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

    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?

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    Yes, Moderate
    Yes, Minor
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    How Effective is Isovue for You?

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    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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