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Ioversol Side Effects

For the Consumer

Applies to ioversol: injection solution

In addition to its needed effects, some unwanted effects may be caused by ioversol. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking ioversol, check with your doctor or nurse immediately:

Less common or rare
  • Arm, back, or jaw pain
  • blue lips and fingernails
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • chest tightness or heaviness
  • confusion
  • coughing
  • coughing that sometimes produces a pink frothy sputum
  • decrease in the frequency of urination
  • decrease in urine volume
  • difficult, fast, noisy breathing, sometimes with wheezing
  • 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 or welts, itching, or skin rash
  • hoarseness
  • increased sweating
  • nausea
  • nervousness
  • painful urination
  • pale skin
  • pounding in the ears
  • redness of the skin
  • sensation of spinning
  • severe numbness, especially on one side of the face or body
  • severe, unusual tiredness or weakness
  • slow, fast, or irregular heartbeat
  • slow or irregular breathing
  • sweating
  • swelling around the eyes
  • swelling in the legs and ankles
  • unusual tiredness or weakness
Rare
  • Blood in the stools or urine
  • bruising
  • changes in skin color
  • coughing or vomiting blood
  • pains in the chest, groin, or legs, especially calves of the legs
  • pain, tenderness, or swelling of the foot or leg
  • persistent bleeding or oozing from puncture sites, mouth, or nose
  • severe headaches of sudden onset
  • sudden loss of coordination
  • sudden onset of shortness of breath for no apparent reason
  • sudden onset of slurred speech
  • sudden vision changes
Incidence not known
  • Extremely high fever or body temperature
  • fast, shallow breathing
  • fast, weak heartbeat
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • muscle cramps
  • no sensation in the legs
  • not able to pass urine
  • pale, clammy skin
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  • thirst
  • unable to move the legs

Some of the side effects that can occur with ioversol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common or rare
  • Bad taste
  • collection of blood under the skin
  • deep, dark purple bruise
  • dry mouth
  • pain, redness, or pale skin at the injection site
  • 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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Optiray 350 (ioversol)." Mallinckrodt Medical Inc, St. Louis, MO.

Not all side effects for ioversol may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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