Omnipaque

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Omnipaque

Property Description
Active ingredient Iohexol
Pharmacological class Radiographic Contrast Agent
Molecular Type Non-ionic, Iodinated
Manufacturer GE Healthcare
Regulatory Status Prescription-only (Rx)
General Purpose Diagnostic Imaging Enhancement

1. Defining Omnipaque: A Non-Ionic Radiopaque Agent

Omnipaque is the trade name for the active ingredient Iohexol, which is categorized as a specialized, prescription-only diagnostic agent manufactured by GE Healthcare. This solution is used exclusively to enhance the clarity of internal structures during medical imaging procedures. Iohexol is definitively classified as an iodinated contrast medium. This placement confirms its role in imaging, rather than its use as a therapeutic medicine to cure or treat disease. Iohexol's unique feature is its modern chemical design as a non-ionic agent, a type clinically recognized for offering improved physiological compatibility compared to older ionic contrast substances.

2. Iohexol Composition and Available Form

The functional basis of Omnipaque is the synthetic, single-ingredient substance Iohexol, which is a triiodinated benzene derivative incorporating three iodine atoms crucial for X-ray absorption. The product is supplied as a clear, sterile solution using an aqueous vehicle (Water for Injection). The formulation is approved for multiple administration routes, including intravascular (into the circulatory system), oral, and intracavitary routes. The structural properties of Iohexol allow it to be safely delivered across a range of diagnostic requirements.

3. General Diagnostic Purpose and Benefit

The general purpose of using Omnipaque is to provide essential contrast enhancement in diagnostic imaging. By temporarily increasing the radiographic density of areas like blood vessels or anatomical cavities, the agent allows these structures to be clearly outlined and visualized on X-ray or CT scans. This sharp visualization facilitates the accurate differentiation of tissues and structural features, thereby significantly aiding medical professionals in formulating an accurate diagnosis.

What side effects are possible with Omnipaque?

Possible side effects and safety information

The safety profile of Iohexol (Omnipaque) is formally established through regulatory classifications that document potential adverse reactions and their frequency of occurrence, primarily categorized by government health authorities like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

Adverse reactions are classified into System-Organ Classes (SOCs), which include Nervous System Disorders, Cardiac Disorders, Renal and Urinary Disorders, and Immune System Disorders. Reactions are further grouped by frequency:

  • Common Reactions: Typically include a sensation of feeling hot, headache, nausea, and localized pain at the administration site.
  • Uncommon Reactions: May involve vomiting, dizziness, tremor, and urticaria (hives).
  • Rare Reactions: Documented events of lower frequency include hypotension (low blood pressure), bradycardia (slow heart rate), dyspnea (difficulty breathing), and cardiac arrest.

Serious Adverse Reactions and Safety Constraints

The official labeling notes specific serious adverse reactions, such as life-threatening anaphylactic/anaphylactoid reactions and the risk of Contrast-Induced Acute Kidney Injury (CIAKI). Other serious events include seizures and Thyroid Storm in susceptible patients. CIAKI typically manifests 24 to 72 hours following intravascular administration.

Population-Specific Safety: The regulatory profile highlights specific risks for certain groups. Neonates and infants are noted for a risk of thyroid dysfunction, and patients with pre-existing renal impairment have an increased risk of CIAKI. The use of Iohexol is formally contraindicated in patients with manifest thyrotoxicosis.

Overdose and Emergency Response

The regulatory profile for Omnipaque (Iohexol) defines overexposure primarily through the risk of severe systemic and neurological manifestations. Manifestations of overdose, particularly those arising from inadvertent overexposure to the central nervous system, include severe neurological effects such as convulsions, seizures, cerebral hemorrhage, and coma.

Severe outcomes officially documented in regulatory labeling include life-threatening events such as acute renal failure (Contrast-Induced Acute Kidney Injury), rhabdomyolysis, cardiac arrest, and death. Because of these potential severe outcomes, government regulators mandate that emergency equipment and trained personnel must always be immediately available for the treatment of serious reactions.

Urgent medical help must be sought immediately if any life-threatening symptoms are encountered during or shortly after administration.

Management of an established overdose is described as entirely symptomatic and supportive, as no specific antidote is officially documented. For instance, in the event of seizures resulting from central nervous system overexposure, intravenous diazepam or phenobarbital sodium is the officially recommended supportive measure. A specific population consideration is noted for patients with pre-existing renal impairment, who are at increased risk due to the physiological finding of prolonged plasma iohexol levels and delayed clearance.

Therapeutic Uses of Omnipaque

What Omnipaque Supports: Key Domains of Use and Patient Benefits

Omnipaque is relevant for use in diagnostic procedures across various clinical contexts, providing essential support that helps the medical team in addressing the overall symptom load by clarifying the underlying context of discomfort. This agent is used across domains where short-term symptomatic assistance is appropriate.

Easing Symptoms of Acute Functional Strain

This domain is applicable when patients experience sudden or escalating symptoms that create noticeable functional strain. Omnipaque is relevant when supportive diagnostic management is appropriate and helps maintain a sense of stability when symptoms are more noticeable, by supporting a clearer assessment. It may assist with symptomatic management in conditions involving episodic or fluctuating manifestations.

Quick Fact: Relevant for Symptom Patterns

Supporting Management of Deep-Seated Symptom Patterns

This category is relevant in contexts marked by increased discomfort or tension. Applied in situations involving certain distressing symptoms, Omnipaque contributes to easing the overall symptom load. It supports the patient during difficult episodes by easing distress and contributing to the appropriate clinical evaluation.

Regulatory References

  1. NIH DailyMed overview for Omnipaque

Eligibility and Restrictions for Use

Official Eligibility Rules for Omnipaque (Iohexol) Use

The eligibility profile for Omnipaque is defined by regulatory authorities based on patient population, clinical status, and administration route. The medicine is generally permitted for use in adults and pediatric patients across its various labeled indications, including intravenous, intra-arterial, and intrathecal procedures, and use in body cavities.

Absolute Contraindications

Official labeling strictly prohibits the use of Omnipaque in patients with a known hypersensitivity to iohexol or any component of the formulation. Additionally, specific concentrations (e.g., 140 mg I/mL and 350 mg I/mL) are contraindicated for intrathecal use (spinal procedures). Immediate repeat myelography is also prohibited.

Population Restrictions and Cautions

Classification Rule/Restriction
Age Restriction Pediatric patients 0 to 3 years of age require monitoring for thyroid dysfunction.
Organ Function Use requires special caution in patients with pre-existing renal impairment to mitigate the risk of acute kidney injury.
Pregnancy Use is not recommended in human pregnancy unless considered essential. For hysterosalpingography, use is contraindicated during pregnancy or suspected pregnancy.
Comorbidities Use requires caution in patients with conditions such as pheochromocytoma or sickle cell disease.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Iohexol (Omnipaque) interactions is categorized by pharmacokinetic and pharmacodynamic outcomes that require specific restrictions or timing rules.

Documented Interaction Patterns

Interacting Substance Official Regulatory Restriction or Outcome
Metformin Requires mandatory cessation at or prior to Iohexol administration. This is due to the documented risk of increased Metformin toxicity from possible worsening of renal function, particularly in patients with existing renal impairment. Resumption is contingent on eGFR re-evaluation 48 hours post-procedure.
CNS Active Drugs Substances like MAO inhibitors, tricyclic antidepressants, and CNS stimulants must be discontinued for at least 48 hours before intrathecal administration (myelography) and should not be resumed for 24 hours afterward. This is based on the official pharmacodynamic risk of an additive effect in lowering the seizure threshold. Phenothiazine derivatives are not recommended for co-use in this context.
Radioactive Iodine (I-131, I-123) Iohexol is officially documented to interfere with the thyroid uptake of these agents and reduce their renal clearance. This interaction can decrease their therapeutic and diagnostic efficacy, with the interference lasting up to eight weeks.
Beta-blockers Their use is formally noted to increase the severity of contrast reactions and reduce the body's responsiveness to epinephrine used to treat hypersensitivity events.
Other Restrictions Alcohol use is documented to increase the risk for seizures and neurological reactions. Iohexol must not be mixed with, or injected in the same intravenous line as, other drugs or total nutritional admixtures.

This official structure provides specific, labeled constraints necessary to manage pharmacokinetic and pharmacodynamic risks associated with Iohexol use.

Mechanism of Action

The Physical Basis of X-ray Contrast

Omnipaque (Iohexol) functions by a physical mechanism rather than a chemical or biological one. The molecule contains iodine atoms which have a high atomic number, enabling them to strongly attenuate (absorb) X-ray photons. This mechanism creates a temporary, high-density visual signal that distinguishes internal body structures, such as blood vessels, from surrounding soft tissue on CT and X-ray images, contributing to the molecule's role in the physical process of contrast generation.


Systemic Distribution and Osmotic Effects

After injection, Omnipaque rapidly distributes through the extracellular fluid space via the circulatory system. As a nonionic, water-soluble molecule, its presence temporarily increases the plasma's concentration of dissolved particles, exerting an osmotic effect. This mild physiological consequence can lead to a fleeting sensation of warmth or flushing. The molecule is not metabolized, and its concentration in the renal tubules causes diuresis (increased urine output) by reducing water reabsorption.


Non-Metabolic Renal Clearance

The physical contrast effect is time-limited due to the drug's rapid clearance. Omnipaque is eliminated almost entirely by the kidneys through glomerular filtration without significant tubular reabsorption. This non-metabolic pathway ensures the swift removal of the agent, limiting the duration of systemic biological interaction and iodine exposure.

Dosage and Administration Information

How to Use Omnipaque: Official Administration Guidelines

Omnipaque (iohexol) is a non-ionic contrast agent used strictly under medical supervision for diagnostic imaging procedures. Its administration is highly protocol-driven, requiring strict adherence to official instructions for specific procedures and patient groups.

Approved Administration Methods

Omnipaque is available in various concentrations of injectable solution and may be administered via several approved routes depending on the required study:

  • Intravascular: Injection into a vein or artery for procedures like angiography or CT scans.
  • Intrathecal: Injection into the spinal canal (subarachnoid space) for myelography.
  • Body Cavity/Local: Administration into joints (arthrography) or other body cavities.
  • Oral/Rectal: Ingestion or rectal administration, often involving dilution, for gastrointestinal tract studies or certain abdominal CT scans.

Dosage and Preparation Requirements

Dosing is not fixed but is highly individualized based on the procedure, imaging site, and patient characteristics (e.g., body weight, age). Specific official guidelines govern the maximum total volume and the iodine concentration (mgI/mL) for each use.

  • Concentration Match: Different concentrations (ranging from 140 mgI/mL to 350 mgI/mL) are labeled for specific uses. For example, some concentrations are explicitly forbidden for intrathecal use.
  • Temperature: The solution may be warmed to body temperature (37°C) before injection, but must not be heated higher.
  • No Mixing: Omnipaque should not be mixed with other medications in the same syringe or IV line.
  • Pediatric Use: Dosing for children is often weight-based, such as 3 mL/kg as a maximum single intravenous dose for some CT procedures.

Any unused portion of the product must be discarded after the procedure, as the solution contains no preservative.

Recent Clinical Evidence

Recent Clinical Evidence Overview

Clinical research involving iohexol (Omnipaque) continues to explore its applications, particularly focusing on optimizing its use across different procedures and patient groups. As a non-ionic, low-osmolar agent, iohexol is frequently studied in comparison to other contrast media to evaluate its profile in various diagnostic imaging settings, including Computed Tomography (CT), angiography, and myelography.


Procedural and Diagnostic Focus

  • Gastrointestinal (GI) Imaging: Recent studies have evaluated iohexol for radiographic and CT imaging of the GI tract following oral or rectal administration in both adult and pediatric populations. Trials have focused on determining the necessary concentrations to achieve diagnostic image quality, sometimes in comparison to agents like diatrizoate. Outcomes often include diagnostic image quality scores and adverse event rates.
  • Cardiac Angiography: Research in cardiac procedures, such as coronary CT angiography, has compared iohexol concentrations (e.g., 350 mg I/mL vs. 380 mg I/mL) and sometimes compared iohexol to other contrast agents to assess vascular enhancement and cardiac function effects. Studies have noted that low-osmolar agents like iohexol may cause less alteration in cardiac function than older, ionic agents.

Safety and Specific Populations

  • Renal Function: Iohexol clearance is routinely studied as a marker for measuring glomerular filtration rate (GFR). Ongoing investigations are assessing whether newer formulations of iohexol may offer a potentially lower risk of contrast-induced acute kidney injury (CI-AKI) in patients with pre-existing renal impairment, which is a major area of research focus.
  • Pediatric Use: Clinical studies specifically address the safety and efficacy of iohexol in children, including its use for CT of the abdomen and pelvis. The research supports its use when appropriate concentrations are employed, often focusing on body-weight-based dosing and dilution parameters.

Frequently Asked Questions (FAQ)

Common questions about Omnipaque (FAQ)


Q: What is the main ingredient in Omnipaque?

The main active ingredient in Omnipaque is the chemical compound iohexol. According to official product descriptions, iohexol is classified as a nonionic, water-soluble radiographic contrast medium, which is the substance responsible for providing visibility during imaging.


Q: Is Omnipaque a type of dye?

While it is sometimes colloquially referred to as a 'dye,' official documents classify Omnipaque as a contrast agent used to help visualize structures during medical scans. It is an iodine-containing solution.


Q: Is it normal to feel a metallic taste after getting Omnipaque?

Adverse event lists compiled from reported data, which are referenced in official product information, note the reported occurrence of a bad, unusual, or unpleasant taste—sometimes described as metallic—or a general change in taste following the administration of contrast agents.


Q: What are the most common reactions reported after receiving Omnipaque?

Official adverse reaction lists for adults receiving the drug by injection (parenteral administration) report the most common reactions to include nausea, headache, taste perversion (metallic taste), and chest pain or angina. The likelihood and type of reaction can vary depending on the specific way the drug is administered.


Q: Can Omnipaque affect kidney function?

Omnipaque is eliminated almost entirely by the kidneys. Official labeling includes a warning regarding the risk of Contrast-Induced Acute Kidney Injury (AKI). Therefore, official information indicates steps are often taken to help minimize this risk.


Q: Is Omnipaque safe for people with thyroid problems?

Official documents advise that patients inform their physician if they have a known thyroid disorder before receiving the drug. Official labeling notes the potential for Thyroid Storm in patients with hyperthyroidism and temporary Thyroid Dysfunction in infants and young children following administration.


Q: What is the difference between Omnipaque and other contrast agents?

Official regulatory text describes Omnipaque (iohexol) as a low-osmolar, non-ionic, iodinated contrast medium. The molecule's non-ionic nature is a key characteristic that distinguishes it from certain older contrast agents used in clinical practice.


Q: What happens if Omnipaque leaks out of the vein?

Leaking out of the vein, known as extravasation, is a potential reaction noted in official warnings. While this leakage can be toxic to surrounding tissues, official warnings indicate that most cases recover without significant long-term effects. Official warnings indicate that management may involve elevation of the affected limb.


Q: Can Omnipaque affect the results of a urine test?

The drug is eliminated by the kidneys, and official documents note this can temporarily cause an increase in urine output (diuresis). Additionally, the drug's iodine content is documented to interfere with certain thyroid function tests, which are usually blood tests, for a period of time.


Q: Is it possible to receive Omnipaque multiple times in a short period?

For specific procedures that may require sequential or repeat examinations, the administration section of the official label advises that a suitable interval of time between administrations should be used. The label also specifies a maximum cumulative total dose for certain procedures.


Q: Are there long-term health effects associated with Omnipaque use?

Official toxicological information generally indicates no known carcinogenic, reproductive, or long-term target organ effects associated with the drug. This is related to the drug's mechanism, which is a physical effect that is time-limited due to its rapid clearance from the body.


Q: Can Omnipaque be used in infants or small children?

Yes. According to regulatory indications, Omnipaque is approved for use in pediatric patients (infants and children) for multiple procedures, including myelography and CT scans. Some specific uses are approved starting as early as 2 weeks of age.


Q: Why is hydration often mentioned in connection with Omnipaque?

Official warnings advise patients to hydrate before and after administration to help minimize the risk of Acute Kidney Injury (AKI) that may occur with the use of contrast agents. Hydration is mentioned because it is intended to help the kidneys effectively clear the compound from the body.


Q: What patient groups are generally not eligible to receive Omnipaque?

Official contraindications prohibit the drug's use in patients with a known hypersensitivity to iohexol (the active ingredient) and those with manifest thyrotoxicosis. The use of the drug may also be restricted based on specific administration routes or pre-existing conditions.


Q: Do studies suggest Omnipaque is safer than older contrast agents?

Regulatory review summaries often contain reviews of clinical trials. For example, some studies reviewed by regulatory bodies supported the drug's use by describing evidence of fewer adverse events compared to certain older control agents in those specific trials.


Q: What is the function of the iodine in Omnipaque?

The iodine atoms are the component that provides the contrast function. They have a high atomic number that allows them to strongly absorb X-ray photons, which creates a temporary, high-density visual signal necessary for imaging.


Q: Is Omnipaque associated with causing hives or rash?

Yes. The official information notes the potential for hypersensitivity reactions (allergic reactions). These reactions commonly manifest as minor cutaneous symptoms such as urticaria (hives), itching, or skin reddening.


Q: Are there different concentrations of Omnipaque used for different tests?

Yes. Omnipaque is manufactured in various iodine concentrations (e.g., 140, 180, 240, 300, and 350 mgI/mL). These different concentrations are labeled and indicated for specific procedures and administration routes, depending on the imaging site and clinical need.


Q: Does Omnipaque contain sugar or gluten?

The official DESCRIPTION section, which lists all components including the active ingredient and inactive excipients, does not list sugar or gluten as components of the solution.


Q: What are the general recommendations for managing mild side effects of Omnipaque?

The official drug information does not offer patient-specific advice. However, general management principles mentioned in practice guidelines may include elevating an affected limb and the use of cold compresses for local pain relief following extravasation.


Q: Is there a maximum amount of Omnipaque a person can receive?

Yes. Official dosing guidelines for specific procedures include a maximum total volume or maximum cumulative total dose. For some procedures, administration guidelines specify a maximum total volume or a maximum cumulative dose of iodine.


Q: Is Omnipaque considered a radioactive drug?

No. Omnipaque is described as an iodinated contrast medium (containing non-radioactive iodine). The official label specifically details an interaction where it can interfere with the thyroid uptake of radioactive iodine (I-131 or I-123) for other diagnostic procedures.


Q: Can Omnipaque affect vision temporarily?

Yes. Official adverse event lists include vision abnormalities (such as blurred vision and photomas) as a reported side effect following intra-arterial or intravenous administration of the drug.


Q: What is the typical time frame to wait between procedures that use Omnipaque?

For repeat procedures, the administration section advises using a suitable interval of time between administrations. Specifically, official information regarding the drug's interference with radioactive iodine uptake notes that this effect can last for up to eight weeks.


Q: How long does Omnipaque stay in the body?

The drug is cleared from the body by the kidneys. According to clinical pharmacology studies, approximately 88% of the injected dose is typically excreted in the urine within the first 24 hours after administration for the intravenous route.


Q: Are there specific foods or drinks to avoid before or after getting Omnipaque?

Official labeling for certain administration routes (myelography) warns against the use of alcohol due to the increased risk for neurological reactions and seizures. General restrictions on foods or non-alcoholic drinks are not typically specified in the drug's main regulatory documents.


Q: What should I tell my doctor about before receiving Omnipaque?

Official patient information advises patients to inform their physician if they are pregnant, diabetic, have multiple myeloma, pheochromocytoma, homozygous sickle cell disease, or a known thyroid disorder. They should also mention any allergies or previous reactions to contrast injections.


Q: Is Omnipaque used for all types of CT scans?

Official indications state that Omnipaque is used for CT of the head and body in adults and children. It is also indicated for CT of the abdomen and pelvis when combined with intravenous administration.


Q: Is Omnipaque given orally or only by injection?

Omnipaque is approved for administration by multiple routes, not just injection. These approved routes include intravenous injection, oral (by mouth), rectal, intrathecal (spinal canal), intraarticular (joints), and administration into other body cavities.


Q: What is the purpose of the official Black Box Warning for Omnipaque?

The official Black Box Warning is included to highlight the serious risk associated with the inadvertent intrathecal administration of specific concentrations that are not formulated for the spinal column. The warning is in place because this misuse can lead to serious adverse reactions, including convulsions and death.


Q: What evidence exists regarding Omnipaque's use in patients with heart conditions?

Official warnings advise special care in patients with severe cardiac disease or cardio-circulatory disease and pulmonary hypertension. These patients may be especially predisposed for cardiac reactions following the administration of the contrast agent.

How should Omnipaque be stored and disposed of?

Omnipaque (iohexol) injection must be stored according to regulatory requirements to preserve its sterility and stability. The unopened product requires storage at Controlled Room Temperature, which is 20 C to 25 C (68 F to 77 F). The solution is sensitive to light and must be protected from exposure. It is mandatory not to freeze Omnipaque; the product must be discarded if freezing occurs.

Stability and Disposal Rules

Single-dose containers are for one procedure only, and any unused portion must be discarded immediately afterward. For the Pharmacy Bulk Package, the maximum allowed use time after the initial closure penetration is 8 hours, after which any remaining solution must be disposed of. As with all medicines, store Omnipaque out of the sight and reach of children.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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