Omnipaque 350 Side Effects
Generic name: iohexol
Medically reviewed by Drugs.com. Last updated on Aug 1, 2024.
Note: This document provides detailed information about Omnipaque 350 Side Effects associated with iohexol. Some dosage forms listed on this page may not apply specifically to the brand name Omnipaque 350.
Applies to iohexol: oral solution.
Other dosage forms:
Serious side effects of Omnipaque 350
Along with its needed effects, iohexol (the active ingredient contained in Omnipaque 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 iohexol:
Less common
- blurred vision
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- unusual tiredness or weakness
Incidence not known
- agitation
- black, tarry stools
- blistering, peeling, or loosening of the skin
- bloating
- bluish color of the fingernails, lips, skin, palms, or nail beds
- changes in skin color, pain, tenderness, or swelling of the foot or leg
- chills
- constipation
- cough
- darkened urine
- decreased urine output
- depressed mood
- diarrhea
- difficulty swallowing
- discouragement
- drowsiness
- dry skin and hair
- feeling sad or empty
- hair loss
- headache
- hoarseness or husky voice
- hives, itching, skin rash
- indigestion
- irritability
- joint or muscle pain
- lack of appetite
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of consciousness
- loss of interest or pleasure
- lower back or side pain
- mood or mental changes
- muscle twitching, cramps, and stiffness
- nervousness
- painful or difficult urination
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- red, irritated eyes
- red skin lesions, often with a purple center
- seeing, hearing, or feeling things that are not there
- sensitivity to heat
- slowed heartbeat
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stiff neck
- swollen glands
- throat irritation or tightness
- trouble concentrating
- trouble sleeping
- unusual drowsiness, dullness, or feeling of sluggishness
- weight loss
- yellow eyes or skin
Other side effects of Omnipaque 350
Some side effects of iohexol 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
- change in taste
Rare
- anxiety
- belching
- cold sweats
- dry mouth
- heartburn
- increased hunger
- indigestion
- nightmares
- redness of the skin
- shakiness
- sleepiness or unusual drowsiness
- slurred speech
- sneezing
- stomach discomfort, upset, or pain
- stuffy or runny nose
- uncontrolled eye movements
For healthcare professionals
Applies to iohexol: injectable solution, oral solution.
General
The most frequently reported adverse reactions are headache, mild to moderate pain including backache, neckache and stiffness, nausea, and vomiting. These reactions usually occur 1 to 10 hours after injection, and almost all occur within 24 hours. They are usually mild to moderate in degree, lasting for a few hours, and usually disappearing within 24 hours.[Ref]
Gastrointestinal
- Very common (10% or more): Diarrhea (oral/body cavity routes)
- Common (1% to 10%): Nausea, vomiting, pancreatitis (endoscopic retrograde cholangiopancreatography), lower abdominal pain (hysterosalpingography)
- Uncommon (0.1% to 1%): Abdominal pain, stomach ache
- Rare (0.01% to 0.1%): Diarrhea
- Very rare (less than 0.01%): Tenderness and/or enlargement of the salivary glands ("iodide mumps"), abdominal discomfort
- Frequency not reported: Aggravation of pancreatitis, acute pancreatitis[Ref]
Nervous system
- Very common (10% or more): Headache (may be severe and prolonged)
- Common (1% to 10%): Dizziness (2%), neuralgia
- Uncommon (0.1% to 1%): Aseptic meningitis syndrome (including chemical meningitis), visual hallucinations, somnolence, hemiparesis, transient ischemic attack, cerebral infarction, syncope
- Rare (0.01% to 0.1%): Seizure, neurological changes, drowsiness, transitory peripheral neuropathies (sensory and/or motor or nerve root disturbances, myelitis, persistent leg muscle pain or weakness, 6th nerve palsy, or cauda equina syndrome)
- Very rare (less than 0.01%): Dysgeusia (transient metallic taste), disturbance in consciousness, transient contrast-induced encephalopathy (including transient memory loss, coma, stupor, retrograde amnesia), sensory abnormalities (including hypoesthesia), paraesthesia, tremor
- Frequency not reported: Syncope vasovagal, motor dysfunction (including speech disorder, aphasia, dysarthria), disorientation, abnormal electroencephalogram, meningism[Ref]
Rarely, headaches may be severe or persist for days. Headache is often accompanied by nausea and vomiting and tends to be more frequent and persistent in patients not optimally hydrated.
Aseptic meningitis syndrome was usually preceded by pronounced headaches, nausea and vomiting. Onset usually occurred about 12 to 18 hours postprocedure. Prominent features were meningismus, fever, sometimes with oculomotor signs and mental confusion. Lumbar puncture revealed a high white cell count, high protein content often with a low glucose level and with absence of organisms. The condition usually started to clear spontaneously about 10 hours after onset, with complete recovery over 2 to 3 days.[Ref]
Other
- Very common (10% or more): Pain
- Common (1% to 10%): Feeling hot
- Uncommon (0.1% to 1%): Discomfort, fever, hives
- Rare (0.01% to 0.1%): Pyrexia, asthenic conditions (including malaise, fatigue), feeling of heaviness, tinnitus, vertigo
- Very rare (less than 0.01%): Shivering (chills)
- Frequency not reported: Transient hearing loss[Ref]
Metabolic
- Common (1% to 10%): Blood amylase increased
- Uncommon (0.1% to 1%): Hypoglycemia in pediatrics (0.3%)
- Rare (less than 0.1%): Loss of appetite
- Frequency not reported: Iodism[Ref]
Musculoskeletal
- Common (1% to 10%): Back pain
- Rare (less than 0.1%): Neck pain, pain in extremity, hypertonia
- Frequency not reported: Muscle spasm, arthralgia, arthritis, muscle cramps, fasciculation or myoclonia, spinal convulsion, spasticity, stiff neck[Ref]
Severe pain may often result from undue use of pressure or the injection of large volumes. Joint swelling after injection is less with iohexol than with high osmolar ionic contrast medium. These types of reactions are generally procedurally dependent and of greater frequency when double-contrast technique is employed.[Ref]
Ocular
- Common (1% to 10%): Vision abnormalities (including blurred vision and photomas) (2%)
- Uncommon (0.1% to 1%): Nystagmus (less than 0.3%)
- Rare (less than 0.1%): Photophobia, ocular muscles weakness
- Frequency not reported: Transient cortical blindness[Ref]
Renal
- Common (1% to 10%): Transient increase in serum creatinine (contrast induced nephropathy may occur)
- Rare (less than 0.1%): Impairment of renal function including acute renal failure[Ref]
Cardiovascular
- Uncommon (0.1% to 1%): Angina, chest pain, anemia in pediatrics(0.3%)
- Rare (0.01% to 0.1%): Bradycardia, arrhythmia, hypotension, hypertension
- Very rare (less than 0.01%): Myocardial infarction, flushing
- Frequency not reported: Severe cardiac complications (including cardiac arrest, cardio-respiratory arrest), spasm of coronary arteries, chest pain, shock, arterial spasm, ischemia, thrombophlebitis, thrombosis[Ref]
Dermatologic
- Uncommon (0.1% to 1%): Urticaria, purpura, abscess, pruritus
- Frequency not reported: Severe pustular or exfoliative or bullous dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, rash with eosinophilia and systemic symptoms, psoriasis flare-up[Ref]
Respiratory
- Uncommon (0.1% to 1%): Dyspnea, rhinitis, coughing, laryngitis
- Rare (0.01% to 0.1%): Cough
- Very rare (less than 0.01%): Non-cardiogenic pulmonary edema
- Frequency not reported: Severe respiratory symptoms and signs, bronchospasm, laryngospasm, asthma attack[Ref]
Genitourinary
- Rare (less than 0.1%): Difficulty in micturition[Ref]
Hypersensitivity
- Rare (less than 0.1%): Hypersensitivity (including dyspnea, rash, erythema, urticaria, pruritus, skin reaction, vasculitis, angioneurotic edema, laryngeal edema, laryngospasm, bronchospasm or non-cardiogenic pulmonary edema)
- Frequency not reported: Anaphylactic/anaphylactoid reaction, anaphylactic/anaphylactoid shock[Ref]
The hypersensitivity reactions 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]
Endocrine
- Very rare (less than 0.01%): Sweating
- Frequency not reported: Thyrotoxicosis, transient hypothyroidism (premature infants, neonates premature breast fed infant, and in other children)[Ref]
Local
- Frequency not reported: Administration site reactions, including extravasation[Ref]
Psychiatric
- Frequency not reported: Confusion, anxiety[Ref]
References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. (2007) "Product Information. Omnipaque 180 (iohexol)." Amersham Health
3. Cerner Multum, Inc. "Australian Product Information."
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Further information
Omnipaque 350 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.
Some side effects may not be reported. You may report them to the FDA.