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Optiray Injection

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Optiray Injection

Optiray Injection

Optiray Injection Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Optiray (ioversol) is used to help diagnose certain disorders of the heart, brain, and blood vessels. It is in a group of drugs called radiopaque contrast agents. It contains iodine, a substance that absorbs x-rays. Common side effects include fever, warmth, pain, skin rash or redness, headache, or nausea.

As with all radiopaque contrast agents, only the lowest dose of Optiray necessary to obtain adequate visualization should be used. A lower dose may reduce the possibility of an adverse reaction. Optiray may interact with other drugs. Tell your doctor all medications and supplements you use. Optiray is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Optiray (ioversol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Optiray Injection in Detail - Patient Information: Side Effects

Some of the side effects of ioversol can occur up to 24 hours after you have received the medication.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • urinating less than usual or not at all;
  • severe muscle pain or weakness;
  • seizure (convulsions);
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • feeling light-headed, fainting;
  • wheezing, trouble breathing;
  • fast or slow heartbeat;
  • easy bruising, unusual bleeding, or skin changes; or
  • swelling of your hands, ankles, or feet.

Other less serious side effects are more likely to occur, such as:

  • fever, warmth, or pain;
  • skin rash or redness;
  • headache; or
  • nausea.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Optiray Injection (Ioversol Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Optiray Injection FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse reactions following the use of OPTIRAY formulations are usually mild to moderate, of short duration and resolve spontaneously (without treatment). However, serious, life-threatening and fatal reactions, mostly of cardiovascular origin, have been associated with the administration of iodine-containing contrast media.

Injections of contrast media are often associated with sensations of warmth and pain. In controlled double-blind clinical studies, significantly less warmth and pain were associated with the injection of OPTIRAY than with iothalamate meglumine, diatrizoate meglumine, and diatrizoate meglumine and diatrizoate sodium.

When OPTIRAY was used for coronary arteriography and ventriculography in double-blind clinical trials, electrocardiographic and hemodynamic changes occurred with less frequency and severity with ioversol injection than with diatrizoate meglumine and diatrizoate sodium.

Following coronary artery and left ventricular injection, electrocardiographic parameters were affected less with OPTIRAY (ioversol injection) than with diatrizoate meglumine and diatrizoate sodium injection. These parameters included the following: bradycardia, tachycardia, T-wave amplitude, ST depression and ST elevation.

OPTIRAY has also been shown to cause fewer changes in cardiac function and systemic blood pressure than conventional ionic media. These include cardiac output, left ventricular systolic and end-diastolic pressure, right ventricular systolic and pulmonary artery systolic pressures and decreases in systolic and diastolic blood pressures.

The following table of incidence of reactions is based upon clinical trials with OPTIRAY formulations in 2,098 patients. This listing includes all adverse reactions which were coincidental to the administration of ioversol regardless of their direct attributability to the drug or the procedure. Adverse reactions are listed by organ system and in decreasing order of occurrence. Significantly more severe reactions are listed before others in a system regardless of frequency.

Adverse Reactions
System >1% ≤ 1%
Cardiovascular none angina pectoris
hypotension
blood pressure fluctuation
arterial spasm
bradycardia
conduction defect
false aneurysm
hypertension
transient arrhythmia
vascular trauma
Digestive nausea (1.2) vomiting
dry mouth
Nervous headache (1.1) cerebral infarct
blurred vision
vertigo
lightheadedness
visual hallucination
vasovagal reaction
disorientation
paresthesia
dysphasia
muscle spasm
syncope
Respiratory none laryngeal edema
pulmonary edema
sneezing
congestion
coughing
shortness of breath
hypoxia
Skin none periorbital edema
urticaria
pruritus
facial edema
flush
erythema
Miscellaneous none extravasation
hematoma
shaking chills
bad taste
general pain
renal colic
fever
polyuria
urinary retention

Regardless of the contrast medium employed, the overall incidence of serious adverse reaction is higher with coronary arteriography than with other procedures. Cardiac decompensation, serious arrhythmias, myocardial ischemia or myocardial infarction may occur during coronary arteriography and left ventriculography.

Pediatrics

In controlled clinical trials involving 159 patients for pediatric angiocardiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography, adverse reactions reported were as follows: fever (1.3%), nausea (0.6%), muscle spasm (0.6%), LV pressure changes (0.6%).

General Adverse Reactions to Contrast Media

The following adverse reactions are possible with any parenterally administered iodinated contrast medium. Severe life-threatening reactions and fatalities, mostly of cardiovascular origin, have occurred. Most deaths occur during injection or 5 to 10 minutes later; the main feature being cardiac arrest with cardiovascular disease as the main aggravating factor. Isolated reports of hypotensive collapse and shock are found in the literature. Based upon clinical literature, reported deaths from the administration of conventional iodinated contrast agents range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent).

The reported incidence of adverse reactions to contrast media in patients with a history of allergy is twice that of the general population. Patients with a history of previous reactions to a contrast medium are three times more susceptible than other patients. However, sensitivity to contrast media does not appear to increase with repeated examinations.

Adverse reactions to injectable contrast media fall into two categories: chemotoxic reactions and idiosyncratic reactions.

Chemotoxic reactions result from the physiochemical properties of the contrast medium, the dose and the speed of injection. All hemodynamic disturbances and injuries to organs or vessels perfused by the contrast medium are included in this category.

Idiosyncratic reactions include all other reactions. They occur more frequently in patients 20 to 40 years old. Idiosyncratic reactions may or may not be dependent on the dose injected, the speed of injection, the mode of injection and the radiographic procedure. Idiosyncratic reactions are subdivided into minor, intermediate and severe. The minor reactions are self-limited and of short duration; the severe reactions are life-threatening and treatment is urgent and mandatory.

In addition to the adverse reactions reported for ioversol, the following additional adverse reactions have been reported with the use of other contrast agents and are possible with any water soluble, iodinated contrast agent.

Nervous: convulsions, aphasia, paralysis, visual field losses which are usually transient but may be permanent, coma and death.

Cardiovascular: angioneurotic edema, peripheral edema, vasodilation, thrombosis and rarely thrombophlebitis, disseminated intravascular coagulation and shock.

Skin: maculopapular rash, erythema, conjunctival symptoms, ecchymosis and tissue necrosis.

Respiratory: choking, dyspnea, wheezing which may be an initial manifestation of more severe and infrequent reactions including asthmatic attack, laryngospasm and bronchospasm, apnea and cyanosis. Rarely these allergic-type reactions can progress into anaphylaxis with loss of consciousness, coma, severe cardiovascular disturbances and death.

Miscellaneous: hyperthermia, temporary anuria or other nephropathy. Other reactions may also occur with the use of any contrast agent as a consequence of the procedural hazard; these include hemorrhage or pseudoaneurysms at the puncture site, brachial plexus palsy following axillary artery injections, chest pain, myocardial infarction, and transient changes in hepatorenal chemistry tests. Arterial thrombosis, displacement of arterial plaques, venous thrombosis, dissection of the coronary vessels and transient sinus arrest are rare complications.

(Adverse reactions for specific procedures receive comment in the Indications, Usage and Procedural Information section).

Read the entire FDA prescribing information for Optiray Injection (Ioversol Injection) »

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Report Problems to the Food and Drug Administration

 

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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