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Isovue Side Effects

Report Isovue Side Effects

If you experienced any harmful or unwanted effects of Isovue, please share your experience. This could help to raise awareness about Isovue side effects, identify uknown risks and inform health professionals and patients taking Isovue.

Examples: headache, dizziness


The most commonly reported Isovue side effects are:
EXTRAVASATION (9 reports)
Infiltration (2 reports)
Flushing (1 reports)
Hives (1 reports)
Hives And Tongue Swelling (1 reports)
TACHYCARDIA AND HOT FLASH (1 reports)
Tongue Swelling (1 reports)

If you have experienced a side effect listed above, you can check a box to report it.


To view a complete list of submitted side effects, please follow the link Isovue side effects . You can also compare Isovue side effects or view FDA reports.

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).
The 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 identified a causal relationship between the drug and the listed risk.

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Hypotension, Dyspnoea, Swollen Tongue, Lip Swelling
on Feb 26, 2014 Male from US , 64 years of age, weighting 235.9 lb, was diagnosed with and was treated with Isovue 370. Directly after, patient experienced the unwanted or unexpected Isovue side effects: hypotension, dyspnoea, swollen tongue, lip swelling. Isovue 370 dosage: N/A.
Associated medications used: Patient was hospitalized.

Hypertension, Dizziness
Patient was taking Isovue 370. Patient felt the following Isovue side effects: hypertension, dizziness on Feb 26, 2014 from US Additional patient health information: Male , 66 years of age, weighting 172.0 lb, was diagnosed with and. Isovue 370 dosage: N/A.

Breath Sounds Abnormal, Chest Discomfort, Oropharyngeal Pain, Dysphagia, Tinnitus, Ear Pain
Adverse event was reported on Feb 10, 2014 by a Male taking Isovue 370 (Dosage: N/A) was diagnosed with and. Location: US , 58 years of age, weighting 210.0 lb, After Isovue was administered, patient encountered several Isovue side effects: breath sounds abnormal, chest discomfort, oropharyngeal pain, dysphagia, tinnitus, ear pain.
Multiple concurrent drugs taken:

Sneezing, Throat Irritation, Heart Rate Increased
on Feb 06, 2014 Female from US , 24 years of age, weighting 164.9 lb, was diagnosed with and was treated with Isovue 300. Directly after, patient experienced the unwanted or unexpected Isovue side effects: sneezing, throat irritation, heart rate increased. Isovue 300 dosage: N/A.


Oral Pruritus, Lip Pruritus, Oral Mucosal Erythema, Urticaria
on Feb 06, 2014 Female from US , 70 years of age, weighting 154.1 lb, was diagnosed with and was treated with Isovue 370. Patient felt the following Isovue side effects: oral pruritus, lip pruritus, oral mucosal erythema, urticaria. Isovue 370 dosage: N/A.

Contrast Media Allergy
Patient was taking Isovue 300. After Isovue was administered, patient encountered several Isovue side effects: contrast media allergy on Dec 23, 2013 from US Additional patient health information: Female , 27 years of age, weighting 124.1 lb, was diagnosed with and. Isovue 300 dosage: N/A.

Sinus Congestion, Throat Irritation, Oxygen Saturation Decreased, Contrast Media Reaction
Adverse event was reported on Dec 05, 2013 by a Male taking Isovue 300 (Dosage: N/A) was diagnosed with and. Location: US , 30 years of age, weighting 242.5 lb, Directly after, patient experienced the unwanted or unexpected Isovue side effects: sinus congestion, throat irritation, oxygen saturation decreased, contrast media reaction.

Dry Throat, Oropharyngeal Spasm, Chills
on Dec 05, 2013 Male from US , 62 years of age, weighting 179.2 lb, was diagnosed with and was treated with Isovue 300. Patient felt the following Isovue side effects: dry throat, oropharyngeal spasm, chills. Isovue 300 dosage: N/A.

Rash, Eye Swelling, Headache, Nausea, Pharyngeal Oedema, Back Pain, Hypoaesthesia, Injection Site Hypoaesthesia, Skin Disorder
on Nov 18, 2013 Female from US , 41 years of age, weighting 167.6 lb, was diagnosed with and was treated with Isovue. After Isovue was administered, patient encountered several Isovue side effects: rash, eye swelling, headache, nausea, pharyngeal oedema, back pain, hypoaesthesia, injection site hypoaesthesia, skin disorder. Isovue dosage: N/A.

Sneezing, Swelling Face, Toothache, Hypoaesthesia Oral, Facial Pain, Oedema Mouth
Patient was taking Isovue 370. Directly after, patient experienced the unwanted or unexpected Isovue side effects: sneezing, swelling face, toothache, hypoaesthesia oral, facial pain, oedema mouth on Oct 18, 2013 from US Additional patient health information: Female , 36 years of age, weighting 211.9 lb, was diagnosed with and. Isovue 370 dosage: N/A.

Urticaria
Adverse event was reported on Oct 18, 2013 by a Female taking Isovue-370 (Dosage: N/A) was diagnosed with and. Location: US , 71 years of age, weighting 172.0 lb, Patient felt the following Isovue side effects: urticaria.

Anaphylactic Reaction, Pneumonia Aspiration, Cardiac Arrest, Postresuscitation Encephalopathy, Hypokalaemia
on Oct 16, 2013 Female from US , 70 years of age, weighting 198.4 lb, was diagnosed with and was treated with Isovue 300. After Isovue was administered, patient encountered several Isovue side effects: anaphylactic reaction, pneumonia aspiration, cardiac arrest, postresuscitation encephalopathy, hypokalaemia. Isovue 300 dosage: N/A.
Multiple concurrent drugs taken: Patient was hospitalized.

Contrast Media Reaction, Urticaria, Feeling Hot, Erythema
on Sep 11, 2013 Female from US , 32 years of age, weighting 206.8 lb, was diagnosed with and was treated with Isovue 300. Directly after, patient experienced the unwanted or unexpected Isovue side effects: contrast media reaction, urticaria, feeling hot, erythema. Isovue 300 dosage: N/A.

Urticaria
Patient was taking Isovue 300. Patient felt the following Isovue side effects: urticaria on Jul 15, 2013 from COUNTRY NOT SPECIFIED Additional patient health information: Male , weighting 203.5 lb, was diagnosed with and. Isovue 300 dosage: N/A.

Anaphylactoid Reaction
Adverse event was reported on May 24, 2013 by a Female taking Isovue (Dosage: 20 Cc) was diagnosed with and. Location: US , 62 years of age, After Isovue was administered, patient encountered several Isovue side effects: anaphylactoid reaction.

Acute Respiratory Failure, Pulmonary Oedema, Dyspnoea, Cough
on May 21, 2013 Female from US , 78 years of age, was diagnosed with and was treated with Isovue 300. Directly after, patient experienced the unwanted or unexpected Isovue side effects: acute respiratory failure, pulmonary oedema, dyspnoea, cough. Isovue 300 dosage: N/A. Patient was hospitalized.

Cough, Acute Respiratory Failure, Acute Pulmonary Oedema, Electrocardiogram St Segment Elevation, Cardio-respiratory Arrest
on May 01, 2013 Female from US , 78 years of age, weighting 229.5 lb, was diagnosed with and was treated with Isovue 300. Patient felt the following Isovue side effects: cough, acute respiratory failure, acute pulmonary oedema, electrocardiogram st segment elevation, cardio-respiratory arrest. Isovue 300 dosage: N/A. Patient was hospitalized.

Dyspnoea, Unresponsive To Stimuli, Pulse Absent
Patient was taking Isovue 300. After Isovue was administered, patient encountered several Isovue side effects: dyspnoea, unresponsive to stimuli, pulse absent on Apr 30, 2013 from US Additional patient health information: Female , 63 years of age, was diagnosed with and. Isovue 300 dosage: Ot Iv. Patient was hospitalized.

Anaphylactic Reaction
Adverse event was reported on May 21, 2013 by a Female taking Isovue 300 (Dosage: N/A) was diagnosed with and. Location: US , 63 years of age, Directly after, patient experienced the unwanted or unexpected Isovue side effects: anaphylactic reaction.

Urticaria
on Apr 16, 2013 Female from US , 57 years of age, weighting 149.9 lb, was treated with Isovue 300. Patient felt the following Isovue side effects: urticaria. Isovue 300 dosage: N/A.

Headache, Sensation Of Pressure, Nausea, Vomiting, Confusional State, Mental Status Changes, Convulsion, Hypotension
on Mar 28, 2013 Male from US , 52 years of age, weighting 308.4 lb, was diagnosed with and was treated with Isovue-m 300. After Isovue was administered, patient encountered several Isovue side effects: headache, sensation of pressure, nausea, vomiting, confusional state, mental status changes, convulsion, hypotension. Isovue-m 300 dosage: N/A.

Agitation, Nausea
Patient was taking Isovue 370. Directly after, patient experienced the unwanted or unexpected Isovue side effects: agitation, nausea on Nov 09, 2012 from US Additional patient health information: Female , 73 years of age, was diagnosed with and. Isovue 370 dosage: N/A.

Malaise, Dyspnoea, Pallor, Unresponsive To Stimuli, Cardio-respiratory Arrest
Adverse event was reported on Mar 15, 2013 by a Female taking Isovue (Dosage: N/A) . Location: US , 55 years of age, weighting 198.0 lb, Patient felt the following Isovue side effects: malaise, dyspnoea, pallor, unresponsive to stimuli, cardio-respiratory arrest. Patient was hospitalized.

Acute Respiratory Failure, Endocarditis, Cardiac Failure Congestive, Hyperhidrosis
on Nov 05, 2012 Female from US , weighting 160.9 lb, was diagnosed with and was treated with Isovue 300. After Isovue was administered, patient encountered several Isovue side effects: acute respiratory failure, endocarditis, cardiac failure congestive, hyperhidrosis. Isovue 300 dosage: Lot# 2a67512; Exp. Date: 31-jan-2015: Lot# Ac2p561a; Exp. Date: 31-may-2015. Patient was hospitalized.

Cardiac Arrest, Respiratory Arrest
on Nov 20, 2012 Female from US , weighting 163.1 lb, was diagnosed with and was treated with Isovue 370. Directly after, patient experienced the unwanted or unexpected Isovue side effects: cardiac arrest, respiratory arrest. Isovue 370 dosage: N/A.

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Record and Track Your Side Effects

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.

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JustAnswer.com

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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