Applies to ioversol: injection solution.
Warning
Injection route (Solution)
Risks with Inadvertent Intrathecal AdministrationFor Intra-arterial and Intravenous Use OnlyInadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
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
- 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 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
- 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]