Medical Editor: John P. Cunha, DO, FACOEP
What Is Optiray?
Optiray (ioversol) is a radiopaque contrast agent that contains iodine, a substance that absorbs x-rays, and is used to help diagnose certain disorders of the heart.
What Are Side Effects of Optiray?
Common side effects of Optiray include
Some side effects of Optiray can occur up to 24 hours after receiving the medication.
Dosage for Optiray
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.
What Drugs, Substances, or Supplements Interact with Optiray?
Optiray may interact with other drugs. Tell your doctor all medications and supplements you use.
Optiray During Pregnancy and Breastfeeding
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.
Additional Information
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.
SLIDESHOW
Digestive Disorders: Common Misconceptions See SlideshowGet emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Some of the side effects of ioversol can occur up to 24 hours after you receive the medication.
Tell your caregivers or call your doctor at once if you have:
- trouble breathing;
- a light-headed feeling, like you might pass out;
- slow heartbeats;
- unexplained muscle pain, tenderness, or weakness;
- a skin rash;
- pain, bleeding, or skin changes where the injection was given;
- sudden numbness or weakness (especially on one side of the body), problems with vision or speech;
- chest pain or pressure, pain spreading to your jaw or shoulder; or
- kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath.
Side effects may be more likely in older adults.
Common side effects may include:
- fever; or
- nausea.
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.
Read the entire detailed patient monograph for Optiray Injection (Ioversol Injection)
QUESTION
About how much does an adult human brain weigh? See AnswerSIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Risks Associated with Inadvertent Intrathecal Administration [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Contrast Induced Acute Kidney Injury [see WARNINGS AND PRECAUTIONS]
- Cardiovascular Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Thromboembolic Events [see WARNINGS AND PRECAUTIONS]
- Severe Cutaneous Adverse Reactions [see WARNINGS AND PRECAUTIONS]
Clinical Studies Experience
Adult Patients
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following table shows reactions based upon clinical trials with Optiray (ioversol) in 4,187 patients. Adverse reactions are listed by organ system according to clinical importance. More severe reactions are listed before others in a system regardless of incidence. The most common reaction is nausea, occurring at a rate of 1 percent.
Cardiac Disorders
Cardiac arrest, myocardial infarction, arrhythmia, atrioventricular block complete, atrioventricular block, nodal rhythm, bradycardia, angina pectoris, palpitations
Ear And Labyrinth Disorders
Vertigo, tinnitus
Eye Disorders
Vision blurred, periorbital edema, conjunctivitis
Gastrointestinal Disorders
Vomiting, abdominal pain, dysphagia, dry mouth
General Disorders And Administration Site Conditions
Chest pain, pain, injection site pain, injection site hematoma, extravasation, pyrexia, swelling, asthenia, malaise, fatigue, chills
Infections And Infestations
Rhinitis
Injury, Poisoning, And Procedural Complications
Heart injury, vascular pseudoaneurysm
Investigations
Electrocardiogram ST segment depression, blood pressure decreased
Metabolism And Nutrition Disorders
Acidosis
Musculoskeletal And Connective Tissue Disorders
Muscular weakness, muscle spasms, back pain
Nervous System Disorders
Cerebral infarction, aphasia, tremor, dizziness, presyncope, headache, paraesthesia, dysgeusia
Psychiatric Disorders
Hallucination, visual hallucination, disorientation, anxiety
Renal And Urinary Disorders
Urinary retention, renal pain, polyuria
Respiratory, Thoracic, And Mediastinal Disorders
Laryngeal edema, hypoxia, pulmonary edema, dyspnea, hyperventilation, cough, sneezing, nasal congestion
Skin And Subcutaneous Tissue Disorders
Urticaria, rash, pruritus, swelling face, hyperhidrosis, erythema
Vascular Disorders
Hypertension, hypotension, arterial spasm, vasospasm, vasodilation, flushing
Pediatric Patients
In clinical trials involving 311 patients for pediatric angiocardiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography; 6% of patients reported an adverse reactions, with the most common adverse reactions being nausea and fever. Adverse reactions reported were similar in quality and frequency to the adverse events reported by adults..
Postmarketing Experience
The following adverse drug reactions have been reported during post-approval use of Optiray. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate frequency.
Cardiac disorders: coronary artery spasm, cyanosis, arrhythmia (ventricular fibrillation, tachycardia, extrasystole), ECG abnormal.
Endocrine disorders: thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and pediatric patients, including infants, some patients were treated for hypothyroidism.
Eye disorders: temporary blindness, conjunctivitis (including eye irritation, ocular hyperemia, watery eyes).
Gastrointestinal disorders: tongue edema, salivary hypersecretion.
General disorders and administration site conditions: injection site reactions including pain, hemorrhage, and necrosis especially after extravasation [see WARNINGS AND PRECAUTIONS], face edema, feeling hot.
Immune system disorders: hypersensitivity reactions including fatal anaphylactic shock.
Nervous system disorders: seizure, loss of consciousness, somnolence, hypoesthesia, dyskinesia, amnesia.
Respiratory disorders: respiratory arrest, asthma, bronchospasm, laryngeal spasm and obstruction, throat irritation, dysphonia.
Skin and subcutaneous tissue disorders: Reactions range from mild (e.g. rash, erythema, pruritus, urticaria, and skin discoloration) to severe: [e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN)], acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS).
Vascular Disorders: phlebitis, thrombosis.
Read the entire FDA prescribing information for Optiray Injection (Ioversol Injection)
© Optiray Injection Patient Information is supplied by Cerner Multum, Inc. and Optiray Injection Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.