Ioversol Side Effects
Medically reviewed by Drugs.com. Last updated on Aug 25, 2024.
Applies to ioversol: injection solution.
Important warnings
This medicine can cause some serious health issues
Injection route (solution)
Risks with Inadvertent Intrathecal Administration. For Intra-arterial and Intravenous Use Only. Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
Precautions
It is very important that your doctor check the progress of you or your child closely while you are receiving this medicine to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for any unwanted effects.
This medicine may cause heart attack, stroke, and blood clotting problems during angiographic procedures. Tell your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, faintness, coughing up blood, numbness or weakness in your arm or leg, or on one side of your body, sudden or severe headache, or problems with vision, speech, or walking after receiving this medicine.
Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.
This medicine may cause a serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor or nurse right away if you or your child has chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness after you receive this medicine.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis can occur with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness).
This medicine may cause hypothyroidism (underactive thyroid) in children 3 years of age and younger. Children with congenital (from birth) heart problems may have an increased risk of hypothyroidism. Check with your doctor right away if your child has depressed mood, dry skin and hair, feeling cold, hair loss, hoarseness or a husky voice, muscle cramps and stiffness, slowed heartbeat, weight gain, or unusual tiredness or weakness.
Tell your doctor right away if you or your child have mild, burning pain, feeling of warmth or coldness, peeling of the skin, redness, or swelling at the injection site.
Make sure your doctor knows if you or your child have had an allergic reaction to any dye or medicine given during a test or procedure.
While using this medicine, you may be exposed to radiation. Talk with your doctor if you have concerns about this.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Common side effects of ioversol
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 side effects
- collection of blood under the skin
- deep, dark purple bruise
- dry mouth
- ringing in the ears
- vomiting
Serious side effects of ioversol
Along with its needed effects, ioversol 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 side effects
- 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
For healthcare professionals
Applies to ioversol: injectable solution.
General adverse events
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]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. (2006) "Product Information. Optiray 350 (ioversol)." Mallinckrodt Medical Inc
3. Cerner Multum, Inc. "Australian Product Information."
More about ioversol
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Patient resources
Other brands
Optiray 350, Optiray 160, Optiray 240, Optiray 300, Optiray 320
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Further information
Ioversol side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.