Note: This document contains side effect information about ioversol. Some dosage forms listed on this page may not apply to the brand name Optiray 350.

Applies to ioversol: injection solution.

Serious side effects of Optiray 350

Along with its needed effects, ioversol (the active ingredient contained in Optiray 350) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking ioversol:

Rare

• Arm, back, or jaw pain
• blood in the stools or urine
• blue lips and fingernails
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• bruising
• changes in skin color
• chest pain, discomfort, tightness, or heaviness
• confusion
• coughing
• coughing or vomiting blood
• coughing that sometimes produces a pink frothy sputum
• decrease in the frequency of urination
• decrease in urine volume
• difficult, fast, noisy breathing
• difficulty in passing urine (dribbling)
• difficulty with swallowing
• dizziness or lightheadedness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• feeling of constant movement of self or surroundings
• headache
• hives, itching, or skin rash
• hoarseness
• increased sweating
• nausea
• nervousness
• painful urination
• pains in the chest, groin, or legs, especially calves of the legs
• pain, tenderness, or swelling of the foot or leg
• pale skin
• persistent bleeding or oozing from the puncture sites, mouth, or nose
• pounding in the ears
• rapid weight gain
• redness of the skin
• seizures
• sensation of spinning
• severe headaches of sudden onset
• severe numbness, especially on one side of the face or body
• slow, fast, or irregular heartbeat
• slow or irregular breathing
• stupor
• sudden loss of coordination
• sudden onset of slurred speech
• sudden vision changes
• sweating
• swelling around the eyes
• swelling in the legs and ankles
• unusual tiredness or weakness

Incidence not known

• Agitation
• black, tarry stools
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• blistering, peeling, or loosening of the skin
• chills
• coma
• confusion
• depressed mood
• depression
• diarrhea
• dry skin and hair
• extremely high fever or body temperature
• fast, shallow breathing
• fast, weak heartbeat
• feeling cold
• fever
• hair loss
• hoarseness or husky voice
• hostility
• irritability
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lethargy
• muscle cramps, stiffness, or twitching
• no sensation in the legs
• not able to pass urine
• pale, clammy skin
• red, irritated eyes
• sensitivity to heat
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• swollen glands
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• thirst
• trouble sleeping
• unable to move the legs
• unusual bleeding or bruising
• weight loss

Other side effects of Optiray 350

Some side effects of ioversol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Collection of blood under the skin
• deep, dark purple bruise
• dry mouth
• ringing in the ears
• vomiting

For Healthcare Professionals

Applies to ioversol: injectable solution.

General

Adverse reactions following the use of this drug are generally independent of the dose and usually mild to moderate, of short duration and resolve spontaneously (without treatment).

The most frequently reported adverse reactions were mild discomfort, heat or cold sensation, pain during the injection, transient test perversion, nausea, vomiting, skin reactions such as and urticaria or erythema.^[Ref]

Other

Very common (10% or more): Feeling hot

Common (1% to 10%): Pain

Uncommon (0.1% to 1%): Vertigo, extravasation, shaking, chills, fever, feeling cold

Very rare (less than 0.01%): Tinnitus, edema, malaise, tiredness, sluggishness, feeling abnormal

Frequency not reported: Hyperthermia, pyrexia^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea

Uncommon (0.1% to 1%): Vomiting, dry mouth

Very rare (less than 0.01%): Sialoadenitis, abdominal pain, tongue edema, dysphagia, hypersalivation

Frequency not reported: Diarrhea^[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Cerebral infarct, lightheadedness, vasovagal reaction, disorientation, paresthesia, dysphasia, visual hallucinations, syncope, bad taste

Rare (0.01% to 0.1%): Dizziness, dysgeusia, tremor, convulsions, aphasia, paralysis, coma and death

Very rare (less than 0.01%): Loss of consciousness, speech disorder, somnolence, hypoesthesia, stupor

Frequency not reported: Dyskinesia, amnesia^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Angina pectoris, hypotension, blood pressure fluctuation, arterial spasm, bradycardia, conduction defect, false aneurysm, hypertension, transient, arrhythmia, vascular trauma, hematoma

Rare (less than 0.1%): Arterial thrombosis, displacement of arterial plaques, venous thrombosis, dissection of the coronary vessels, transient sinus arrest, thrombophlebitis, flushing

Very rare (less than 0.01%): Heart block, abnormal ECG, atrial fibrillation, cerebrovascular disorder

Frequency not reported: Tachycardia; T-wave amplitude; ST depression, ST elevation; changes in cardiac output, left ventricular systolic and end-diastolic pressure, right ventricular systolic and pulmonary artery systolic pressure; decreases in systolic and diastolic blood pressure; myocardial infarction; angioneurotic edema, peripheral edema, vasodilation, thrombosis, disseminated intravascular coagulation, shock, cyanosis, extrasystole, palpitations, vasospasm^[Ref]

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.^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Urticaria, pruritus, facial edema, erythema

Rare (0.01% to 0.1%): Rash

Very rare (less than 0.01%): Angioedema, hyperhidrosis (including cold sweat)

Frequency not reported: Maculopapular rash, ecchymosis, tissue necrosis, toxic epidermal necrolysis, acute generalized erythematous pustulosis, erythema multiforme, pallor^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Polyuria, urinary retention

Very rare (less than 0.01%): Incontinence, hematuria

Frequency not reported: Temporary anuria, dysuria^[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision, periorbital edema

Very rare (less than 0.01%): Allergic conjunctivitis (including eye irritation, ocular hyperemia, watery eyes, swelling of conjunctiva, etc.)

Frequency not reported: Transient blindness^[Ref]

Respiratory

Uncommon (0.1% to 1%): Laryngeal edema, pulmonary edema, sneezing, congestion, coughing, shortness of breath, hypoxia

Rare (0.01% to 0.1%): Laryngeal spasm and obstruction (including throat tightness, stridor, etc.), dyspnea, rhinitis, throat irritation

Very rare (less than 0.01%): Pharyngitis

Frequency not reported: Brachial plexus palsy following auxiliary artery injections, chest pain, choking, wheezing (may be an initial manifestation of more severe and infrequent reactions including asthmatic attack), bronchospasm, apnea, respiratory arrest, asthma, dysphonia^[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylaxis with loss of consciousness, coma, severe cardiovascular disturbances and death

Very rare (less than 0.01%): Anaphylactoid reactions^[Ref]

Musculoskeletal

Rare (less than 0.1%): Muscle spasm^[Ref]

Local

Very rare (less than 0.01%): injection site reactions (including pain, erythema, and hemorrhage up to necrosis especially after extravasation)

Frequency not reported: Hemorrhage or pseudoaneurysms at the puncture site^[Ref]

Psychiatric

Very rare (less than 0.01%): Agitation, anxiety, confusion^[Ref]

Renal

Very rare (less than 0.01%): Acute renal failure, abnormal renal function, decreased creatinine clearance, increased BUN

Frequency not reported: Temporary nephropathy, renal colic^[Ref]

Endocrine

Frequency not reported: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression in adult and pediatric patients (including infants)^[Ref]

Hepatic

Frequency not reported: Transient changes in hepatorenal chemistry tests^[Ref]