Iodixanol (Visipaque)

Pronunciation: eye-oh-DIX-uh-nol.

Generic name
iodixanol
Drug class
Non-ionic, dimeric, iso-osmolar iodinated radiographic (X-ray) contrast agent
Form
Solution for injection (270 mg I/mL and 320 mg I/mL strengths, in glass or polypropylene containers)
Route
Intra-arterial or intravenous injection only (never intrathecal)
Legal status
Prescription-only, administered by or under the supervision of a healthcare professional in all markets reviewed

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Visipaque (6) · Full directory

What iodixanol is and how it works

Iodixanol (brand name Visipaque) is an injectable X-ray contrast agent used to help doctors see blood vessels and internal organs more clearly during diagnostic imaging procedures such as angiography, CT scans, and urography. It is given by a healthcare professional, either into an artery or a vein, depending on the procedure. (1) (2)

Visipaque carries a genuine, serious safety warning: it must never be given into the fluid around the spinal cord (intrathecal use), which can cause severe, life-threatening harm. It also carries real, well-documented risks of a temporary reduction in kidney function (contrast-induced nephropathy) and, less commonly, an allergic-type reaction that can range from mild to severe. Your imaging team monitors you closely, especially in the minutes after the injection, and will ask about your kidney health, allergies, and other medicines beforehand.

Mechanism of action: how iodixanol works

Iodixanol is a non-ionic, dimeric, iso-osmolar iodinated X-ray contrast medium; its organically bound iodine attenuates X-rays in blood vessels and tissues, enabling radiographic visualisation. It is eliminated essentially unchanged, predominantly by glomerular filtration, with an elimination half-life of approximately 2.1 hours in adults (4.1 hours in neonates under 2 months) and about 97% recovered unchanged in urine within 24 hours. (1) (2)

What iodixanol is used for

Angiography (blood vessel imaging)

Used intra-arterially for digital subtraction angiography, angiocardiography (imaging of the heart and coronary arteries), and peripheral, visceral, and cerebral arteriography. (1) (2)

CT scanning and coronary CT angiography

Used intravenously to enhance CT imaging of the head and body, and for coronary CT angiography (CCTA) in patients with suspected coronary artery disease. (1)

Urography and venography

Used intravenously for excretory urography (imaging the urinary tract) and peripheral venography (imaging veins). (1)

Other imaging procedures (UK/EU-specific list)

The UK/EU SmPC additionally lists cerebral angiography, myelography, arthrography, and gastrointestinal studies among indicated uses. (2)

Before taking iodixanol

Do not take / not appropriate for

  • Must never be given intrathecally (into the fluid around the spinal cord) -- this is the subject of the boxed warning. (all countries) (1)
  • Must not be given to anyone with a known hypersensitivity (allergic reaction) to iodixanol or its excipients. (United Kingdom, European Union) (2)
  • Must not be given to anyone with manifest thyrotoxicosis (overactive thyroid with symptoms). (United Kingdom, European Union) (2)

Tell your clinician about

  • If you have kidney disease, diabetes, heart failure, advanced blood vessel disease, or multiple myeloma -- these increase the risk of contrast-induced kidney injury.
  • If you have ever had a reaction to a contrast dye or have other allergies, including asthma.
  • If you have a thyroid condition, including an overactive thyroid or thyroid nodules.
  • If you take metformin for diabetes, since it may need to be paused around the time of your scan.
  • If you take a beta-blocker medicine, since this can affect how a reaction to the contrast agent is treated.
  • If you are having, or have recently had, a radioactive-iodine thyroid test or treatment.
  • If you are pregnant or breastfeeding.
  • If your baby is under 3 years old and will be having this procedure, since young children have a documented risk of temporary thyroid changes.
(1) (2)

How to take iodixanol

  • Given only by intra-arterial or intravenous injection by a healthcare professional, in a hospital or clinical imaging setting -- never self-administered and never given intrathecally.
  • You will usually be asked to drink plenty of fluids before and after the procedure to help protect your kidneys.
  • You will be observed for a period after the injection (at least 30 minutes, per the UK/EU source reviewed), since most serious reactions occur within minutes of administration.
  • The specific volume and concentration used depends entirely on the procedure being performed and is decided by the imaging team.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)

Missed dose

Not applicable -- Visipaque is given as a single, clinician-administered injection during a scheduled imaging procedure, not a medicine taken on an ongoing schedule at home.

Overdose

Because Visipaque is administered by a healthcare professional under direct observation, any concern about the amount given is identified and managed immediately by that team, typically with supportive care for fluid balance, kidney function, and any cardiovascular effects. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Altered taste.

What to notice: Altered taste.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Nausea.

What to notice: Nausea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Headache.

What to notice: Headache.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Dizziness or vertigo.

What to notice: Dizziness or vertigo.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Rash or skin redness.

What to notice: Rash or skin redness.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

A feeling of warmth, discomfort, or mild pain at the injection site.

What to notice: A feeling of warmth, discomfort, or mild pain at the injection site.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Angina or chest discomfort.

What to notice: Angina or chest discomfort.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Itching (pruritus).

What to notice: Itching (pruritus).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Contrast-induced kidney injury (nephropathy) — high caution

Symptoms: Usually detected via blood tests (rising creatinine) rather than obvious symptoms; occasionally reduced urine output.

Action: Risk is higher with pre-existing kidney disease, dehydration, diabetes, heart failure, advanced blood vessel disease, older age, multiple myeloma, or other kidney-affecting medicines. Your care team will check kidney function beforehand where relevant, ensure you are well hydrated, and use the lowest effective dose. (1) (2)

Hypersensitivity / anaphylactoid reaction — high caution

Symptoms: Hives, itching, swelling, difficulty breathing, wheezing, dizziness, or fainting.

Action: Most severe reactions develop within minutes of injection, though some can occur hours later. You will be observed for at least 30 minutes after injection, and resuscitation equipment is kept immediately available. Reported death rates in the clinical literature range from about 6.6 per million to 1 in 10,000. Tell your care team about any past reaction to a contrast dye, allergies, or asthma beforehand. (1) (2)

Thyroid storm and thyroid effects — moderate caution

Symptoms: Rapid heartbeat, fever, agitation, sweating (thyroid storm, rare); no obvious symptoms in the paediatric thyroid-suppression signal, detected on testing.

Action: Thyroid storm risk applies mainly to patients with hyperthyroidism or autonomously functioning thyroid nodules. Infants under 3 years old have a documented risk of temporary thyroid hormone suppression, more so with prematurity or congenital heart conditions -- thyroid monitoring may be recommended after the procedure. (1) (2)

Extravasation (contrast leaking outside the vein/artery) — moderate caution

Symptoms: Pain, swelling, or skin changes at the injection site.

Action: May cause tissue damage or compartment syndrome, particularly in people with severe blood vessel disease. Report any pain or swelling at the injection site promptly. (1)

2026 batch quality-defect alert (100 mL polypropylene bottles) — moderate caution

Symptoms: Not a patient symptom -- a product-quality issue identified in specific manufactured batches.

Action: A real World Health Organization Medical Product Alert dated 7 May 2026, originating from Ireland's HPRA, identified metallic particulate matter in specific batches of Visipaque supplied in 100 mL polypropylene bottles (glass containers are NOT affected). This is a batch-level manufacturing quality issue, not a change to the approved safety profile of iodixanol itself; affected batches were recalled from clinical use. Hospitals and clinics follow national recall/alert procedures for any affected stock. (4) (3)

Interactions

  • Metformin: in patients with reduced kidney function (eGFR 30-60 mL/min/1.73m2), a history of liver problems, heavy alcohol use, heart failure, or receiving contrast into an artery, metformin is typically stopped at or before the procedure and kidney function re-checked about 48 hours afterward, because of a risk of lactic acidosis. (1) (2)
  • Beta-blocker medicines: may lower the threshold for a hypersensitivity reaction and can reduce how well epinephrine (adrenaline) works if a reaction needs to be treated. (1) (2)
  • Radioactive iodine (I-131, I-123) thyroid tests or treatment: iodinated contrast can interfere with thyroid iodine uptake for about 6-8 weeks after administration. (1)
  • Interleukin-2 (IL-2) therapy within the previous 2 weeks: increases the risk of a delayed reaction to the contrast agent. (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Not established as safe in pregnancy; used only if the expected benefit to the mother outweighs the potential risk, a decision made by the treating team. (1) (2) (3) (4) (5) (6) (7)

Breastfeeding

Breastfeeding may continue normally after Visipaque is given, per the UK/EU source reviewed. (1) (2) (3) (4) (5) (6) (7)

Children

Used in children for specific procedures with weight-based dosing; infants under 3 years old have a documented risk of temporary thyroid hormone suppression, more so with prematurity or congenital heart conditions. (1) (2) (3) (4) (5) (6) (7)

Elderly

Older age is itself a risk factor for contrast-induced kidney injury; the imaging team will weigh this alongside other individual risk factors. (1) (2) (3) (4) (5) (6) (7)

Hepatic Impairment

A relevant risk factor specifically for the metformin/lactic-acidosis interaction; not otherwise separately addressed with a distinct dose adjustment in the sources reviewed. (1) (2) (3) (4) (5) (6) (7)

Renal Impairment

A major risk factor for contrast-induced kidney injury; the imaging team assesses kidney function beforehand where relevant and takes hydration and dose-minimisation precautions. (1) (2) (3) (4) (5) (6) (7)

Monitoring

Before starting

  • Assessment of kidney function in at-risk patients
  • Allergy/prior contrast-reaction history
  • Thyroid history in at-risk patients
  • Hydration status
  • Current medicines, especially metformin and beta-blockers

During treatment

  • Close observation for at least 30 minutes after injection for signs of a hypersensitivity/anaphylactoid reaction, with resuscitation equipment immediately available.
  • Injection-site monitoring for extravasation.
  • Vital sign monitoring during the procedure.
(1) (2)

Storage

Stored and handled by hospital/clinic staff according to the product's specific storage requirements; not self-stored by patients at home. Any batch subject to a manufacturer or regulator recall (such as the 2026 100 mL polypropylene-bottle alert) is withdrawn from clinical stock per institutional recall procedures.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information and the UK emc SmPC reviewed for this dossier; verify against the current full label before use.

United States

Indication: Intra-arterial angiography/angiocardiography; intravenous CT enhancement, urography, venography, CCTA

Dose summary: Procedure-specific, e.g. coronary arteries 3-10 mL, CT head/body 75-150 mL; maximum adult iodine dose 80 g.

Renal context: Adequate hydration required; use lowest effective dose in patients with renal risk factors; stop metformin per the eGFR-based criteria and re-check renal function at 48 hours. (1)

United Kingdom / European Union

Indication: Cardioangiography, cerebral/peripheral angiography, urography, CT enhancement, myelography, arthrography, gastrointestinal studies

Dose summary: Procedure-specific, e.g. selective coronary arteriography 4-8 mL; adult urography 40-80 mL; paediatric CT enhancement 2-3 mL/kg up to 50 mL.

Renal context: Underlying renal dysfunction is a major CIN risk factor; metformin management depends on eGFR. (2)

Mechanism of action

Hepatic guidance

No specific hepatic-impairment dose adjustment identified in the sources reviewed for this dossier, beyond its relevance as a risk factor for the metformin/lactic-acidosis interaction.

Overdose note

Manage supportively with attention to fluid balance, renal function, and cardiovascular status; iodixanol is dialyzable (36% removed via cellulose membrane, 49% via polysulfone membrane after 4 hours). (1) (2)

Frequently asked questions

Is Visipaque (iodixanol) available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes. This review confirmed iodixanol, marketed as Visipaque, is authorised in all six markets reviewed: the United States, the United Kingdom, the European Union (confirmed directly via Ireland's HPRA), Canada, Australia, and New Zealand. (1) (2) (3) (5) (6) (7)

Why does Visipaque have a boxed warning?

Because it must never be given intrathecally (into the fluid around the spinal cord). Inadvertent intrathecal administration can cause death, seizures, brain haemorrhage, coma, paralysis, and other severe harm. Visipaque is always given by a trained healthcare professional using the correct route for your specific procedure. (1)

Is there a current safety alert about Visipaque?

Yes -- a real, current World Health Organization Medical Product Alert dated 7 May 2026 identified metallic particulate matter in specific batches of Visipaque supplied in 100 mL polypropylene bottles (glass-container Visipaque is NOT affected). This is a manufacturing/batch quality issue, not a change to the approved safety profile of iodixanol itself, and affected batches have been recalled from clinical use by hospitals following national procedures. (4) (3)

Can Visipaque affect my kidneys?

It can, in a minority of patients -- this is called contrast-induced nephropathy. The risk is higher if you have existing kidney disease, diabetes, heart failure, advanced blood vessel disease, are elderly, or take certain other medicines. Your care team reduces this risk by checking your kidney function where relevant, ensuring you are well hydrated, and using the lowest effective dose. (1) (2)

Can I have an allergic reaction to Visipaque?

A hypersensitivity (allergic-type) reaction is possible, ranging from mild skin symptoms to a rare but serious anaphylactoid reaction. Most serious reactions happen within minutes of the injection, which is why you are observed closely afterward, with resuscitation equipment kept immediately available. Tell your care team beforehand about any past reaction to a contrast dye or other allergies. (1) (2)

What is the mechanism of action of iodixanol?

Iodixanol is a non-ionic, dimeric, iso-osmolar iodinated X-ray contrast medium; its organically bound iodine attenuates X-rays in blood vessels and tissues, enabling radiographic visualisation. It is eliminated essentially unchanged, predominantly by glomerular filtration, with an elimination half-life of approximately 2.1 hours in adults (4.1 hours in neonates under 2 months) and about 97% recovered unchanged in urine within 24 hours. (1) (2)

What is the generic name of Iodixanol (Visipaque)?

The generic name is iodixanol. (1) (2)

What class of drug is iodixanol?

Iodixanol (Visipaque) is classed as: Non-ionic, dimeric, iso-osmolar iodinated radiographic (X-ray) contrast agent. (1) (2)

References

  1. VISIPAQUE (iodixanol) injection, solution -- full prescribing informationDailyMed (U.S. National Library of Medicine) -- FDA-approved drug labeling · United States · accessed 2026-07-31 · source 1
  2. VISIPAQUE 320 mg I/ml Solution for Injection, glass container and polypropylene container -- Summary of Product Characteristics (SmPC)electronic medicines compendium (emc), United Kingdom -- GE Healthcare Limited · United Kingdom · accessed 2026-07-31 · source 2
  3. VISIPAQUE 320 mg I/ml Solution for Injection, glass container -- HPRA Ireland marketing authorisation PA0735/009/007Health Products Regulatory Authority (HPRA), Ireland -- national marketing authorisation · European Union (Ireland, as a directly confirmed EU member state) · accessed 2026-07-31 · source 3
  4. Medical Product Alert No1/2026: Substandard ACCUPAQUE (Iohexol), OMNIPAQUE (Iohexol) and VISIPAQUE (Iodixanol)World Health Organization -- Medical Product Alert, originating from an HPRA Ireland notification · Global (multi-country distribution) · accessed 2026-07-31 · source 4
  5. VISIPAQUE (iodixanol injection USP) 270/320 -- Health Canada Product MonographHealth Canada -- Product Monograph · Canada · accessed 2026-07-31 · source 5
  6. VISIPAQUE iodixanol injection -- multiple ARTG entries (vial/bottle/ampoule formats, e.g. ARTG 49594, 49597-49599, 49605-49606, 75924, 75927, 75929-75930)Therapeutic Goods Administration (TGA), Australia -- Australian Register of Therapeutic Goods (ARTG) · Australia · accessed 2026-07-31 · source 6
  7. VISIPAQUE -- New Zealand Data SheetMedsafe (New Zealand regulator) -- New Zealand Data Sheet · New Zealand · accessed 2026-07-31 · source 7

Brand names by country

Single-ingredient iodixanol names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Visipaque320 mg/mL, 270 mg/mL · ge healthcare inc.

United Kingdom

  • Visipaque (2)MHRA licensed emc smpc confirmed · 270 mg I/mL, 320 mg I/mL · GE Healthcare Limited

Canada

  • VISIPAQUE

Australia

  • Visipaque (6)TGA ARTG registered confirmed · 550 mg/mL, 652 mg/mL · GE Healthcare Australia Pty Ltd

New Zealand

  • Visipaque (7)Medsafe registered confirmed · 270 mg I/mL, 320 mg I/mL · per Medsafe data sheet
View brands in additional countries.

European Union

Visipaque (3)

This page provides general reference information about iodixanol (Visipaque) and is not a substitute for advice from the healthcare team performing your procedure. Visipaque is administered only by trained healthcare professionals in a clinical setting.

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