Applies to iodixanol: injection solution.

Serious side effects of Iodixanol

Along with its needed effects, iodixanol 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 iodixanol:

Less common

• Arm, back, or jaw pain
• chest pain, discomfort, tightness, or heaviness
• fainting
• fast or irregular heartbeat
• nausea
• sweating

Rare

• Agitation
• blurred vision
• coma
• confusion
• cough
• decreased urine output
• depression
• difficulty breathing
• dilated neck veins
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• feeling of warmth
• headache
• hostility
• irregular breathing
• irritability
• lethargy
• muscle twitching
• noisy breathing
• rapid weight gain
• redness of the face, neck, arms, and occasionally, upper chest
• seizures
• severe or sudden headache
• stupor
• sudden loss of coordination
• sudden slurring of speech
• swelling of the face, hands, fingers, lower legs, ankles, or feet
• unusual tiredness or weakness
• vomiting

Incidence not known

• Bloating
• chest tightness
• chills
• constipation
• cough
• darkened urine
• depressed mood
• difficulty swallowing
• dry skin and hair
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling cold
• hair loss
• hives, itching, skin rash
• hoarseness or husky voice
• indigestion
• loss of appetite
• muscle cramps and stiffness
• nervousness
• no blood pressure or pulse
• pain, redness, or swelling at the injection site
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pounding in the ears
• problems with speech or speaking
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sensitivity to heat
• slow or fast heartbeat
• stopping of the heart
• trouble sleeping
• unconsciousness
• weight gain or loss
• yellow eyes or skin

Other side effects of Iodixanol

Some side effects of iodixanol 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

• Bad, unusual, or unpleasant (after) taste
• burning, crawling, itching, numbness, prickling, "pins and needles", tingling feeling
• change in taste
• diarrhea
• feeling of constant movement of self or surroundings
• itching or skin rash
• sensation of spinning

Rare

• Acidic or sour stomach
• anxiety
• belching
• continuing ringing or buzzing or other unexplained noise in the ears
• decreased awareness or responsiveness
• dry mouth
• general feeling of discomfort or illness
• hearing loss
• heartburn
• restlessness
• severe sleepiness
• shaking
• stomach discomfort, upset, or pain
• transient, mild, pleasant aromatic odor

Incidence not known

• Sneezing

For Healthcare Professionals

Applies to iodixanol: injectable solution.

General

Serious reactions as well as fatalities are only seen on very rare occasions. Serious adverse reactions may include acute/chronic renal failure, anaphylactic or anaphylactoid shock, hypersensitivity reaction followed by cardiac reactions (Kounis' syndrome), cardiac or cardio-respiratory arrest and myocardial infarction.^[Ref]

Genitourinary

Very common (10% or more): Vaginal hemorrhage (intrathecal)

Uncommon (0.1% to 1%): Hematuria^[Ref]

Cardiovascular

Common (1% to 10%): Angina pectoris, chest pain

Uncommon (0.1% to 1%): Arrhythmias, cardiac failure, conduction abnormalities, hypotension, myocardial infarction, flushing, peripheral ischemia.

Rare (0.01% to 0.1%): Hypotension

Very rare (less than 0.01%): Hypertension, ischemia

Frequency not reported: Ventricular hypokinesia, myocardial ischemia, arterial spasm, thrombosis, thrombophlebitis, thrombocytopenia, cardiorespiratory arrest, spasm of coronary arteries, shock^[Ref]

Dermatologic

Common (1% to 10%): Nonurticarial rash, erythema, pruritus, rash, urticaria

Uncommon (0.1% to 1%): Hematoma, increased sweating

Very rare (less than 0.01%): Angioedema

Frequency not reported: Severe pustular or bullous skin reactions, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms, drug eruption, dermatitis allergic, skin exfoliation^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea

Uncommon (0.1% to 1%): Diarrhea, vomiting, dyspepsia

Very rare (less than 0.01%): Abdominal pain, abdominal discomfort

Frequency not reported: Acute pancreatitis, pancreatitis aggravated, salivary gland enlargement^[Ref]

Local

Common (1% to 10%): Injection site pain^[Ref]

Nervous system

Common (1% to 10%): Headache, migraine, paresthesia

Uncommon (0.1% to 1%): Nervousness, dizziness, sensory disturbance, syncope, parosmia, cerebral vascular disorder, convulsions, hypoesthesia, stupor

Very rare (less than 0.01%): Cerebrovascular accident, amnesia

Frequency not reported: Disturbances in consciousness, coma, motor dysfunction, transient contrast induced encephalopathy (including hallucination), tremor

Postmarketing reports: Dyskinesia^[Ref]

Ocular

Common (1% to 10%): Scotoma

Uncommon (0.1% to 1%): Abnormal vision

Frequency not reported: Transient blindness^[Ref]

Other

Common (1% to 10%): Vertigo

Uncommon (0.1% to 1%): Edema, fatigue, malaise, tinnitus, feeling hot

Rare (0.01% to 0.1%): Pain, pyrexia, shivering (chills), administration site reactions including

extravasation

Very rare (less than 0.01%): Feeling cold, asthenic conditions

Frequency not reported: Iodism^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Pharyngeal edema

Frequency not reported: Anaphylactoid reaction, anaphylactoid shock^[Ref]

Hypersensitivity reactions usually present as respiratory or cutaneous symptoms like dyspnea, rash, erythema, urticaria, pruritus, skin reaction, angioneurotic edema, hypotension, fever, laryngeal edema, bronchospasm or pulmonary edema. They may appear either immediately after the injection or up to a few days later.

Hypersensitivity reactions may occur irrespectively of the dose and mode of administration and mild symptoms may represent the first signs of a serious anaphylactoid reaction/shock.^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Agitation, anxiety, insomnia, confusion^[Ref]

Renal

Uncommon (0.1% to 1%): Abnormal renal function, acute renal failure^[Ref]

Respiratory

Uncommon (0.1% to 1%): Asthma, bronchitis, dyspnea, pulmonary edema, rhinitis

Rare (less than 0.1%): Cough

Frequency not reported: Non-cardiogenic pulmonary edema, respiratory arrest, respiratory failure

Postmarketing reports: Pulmonary embolism, respiratory depression^[Ref]

Musculoskeletal

Rare (less than 0.1%): Back pain

Frequency not reported: Arthralgia

Postmarketing reports: Polymyalgia rheumatica^[Ref]

Hematologic

Postmarketing reports: Hemorrhage^[Ref]

Metabolic

Postmarketing reports: Hypoglycemia^[Ref]