Patient Medication Information: uses, side effects, how to take - Lipiodol Ultra Fluid
Serious Warnings and Precautions
What LIPIODOL ULTRA FLUID is used for:
It is a drug used in X-ray tests.
- Lymphography: to see lymphatic vessels and lymph nodes in adults and children
- Hysterosalpingography: to see the uterus and fallopian tubes in adult women.
- Sialography: to see the salivary glands in adults.
- Fistulography: to see fistulas, a kind of abnormal channel in the body, in adults.
- Selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC): to see tumors in the liver, in adults.
How LIPIODOL ULTRA FLUID works:
LIPIODOL ULTRA FLUID helps tissue to appear darker or brighter depending on the test. This makes it
LIPIODOL ULTRA FLUID is given by a doctor who knows how to treat life threatening reactions. Your doctor will watch your health before, during and after the exam. They know what safety measures to take. They are aware of the possible complications. They are experienced in doing X-ray tests. This drug is only used at sites with drugs, equipment and staff that can handle serious emergencies. They will monitor you for at least 30 minutes after the drug is given. Each patient must have an intravenous line open for use. LIPIODOL ULTRA FLUID should be given slowly with X-ray monitoring. The doctor should not exceed the recommended dose.
Serious or fatal events can occur when LIPIODOL ULTRA FLUID is used. They include:
Blockage of certain blood vessels in the brain (cerebral embolism) or in the lung (pulmonary embolism)
- Worsening chronic liver disease which may last over a period of six months
easier for the doctor to detect any abnormalities. Your doctor performs the test immediately after using LIPIODOL ULTRA FLUID. Your doctor may need to repeat the test after 24-48 hours.
The ingredients in LIPIODOL ULTRA FLUID are:
Medicinal ingredient(s): Ethyl esters of iodized fatty acids of poppy-seed oil.
Non-medicinal ingredients: None
LIPIODOL ULTRA FLUID comes in the following dosage form(s):
- a solution for injection
- supplied as 380 mg iodine/g (38% w/w), corresponding to 480 mg iodine/ mL
- packaged in a self-breaking 10 mL ampoule
Do not use LIPIODOL ULTRA FLUID if:
- you ever had an allergic reaction to Lipiodol Ultra Fluid or to any other iodine product. This can also be called Allergic Disorders
- you have hyperthyroidism,
- you have traumatic injuries or recent bleeding,
- you have acute parotiditis (swelling of the salivary gland) and are imaging salivary glands,
- you are undergoing bronchography. This is a type of X-ray exam of the lung,
you are pregnant or have disease, infection, bleeding or recent surgical procedures of the genital organs. This applies if you need to have an exam of the uterus and fallopian tubes (hysterosalpingography),
- you suffer from heart or lung disease; you have a tumor, recent surgery or radiation therapy that blocks lymph nodes. This applies if you will receive lymphography.
- you have a liver disease and you have blocked bile ducts, unless a drainage tube is in place before the test; you have advanced liver failure or cancer in veins of the liver; or you have cancer spread from the liver. These apply if you will receive Lipiodol Ultra Fluid in your liver.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LIPIDOL ULTRA FLUID. Talk about any health conditions or problems you may have, including if you:
- you suffer or have suffered from an allergy (eg, hay fever, hives) or asthma,
- you suffer from lung or cardiac diseases,
- you have an over-active thyroid,
- you have diabetes,
- you have uterine bleeding and infection,
- you have pelvic inflammation,
you are pregnant or planning to get pregnant. LIPIODOL ULTRA- FLUID can result in brain damage and permanent hypothyroidism (overactive thyroid gland)in the baby. Your healthcare
- professional may monitor you or your baby for signs of hyperthyroidism and goitre (Swelling of the thyroid gland) for some time after you are given LIPIODOL ULTRA- FLUID,
- you are breastfeeding. LIPIODOL ULTRA- FLUID can pass through breast milk. It can result in hypothyroidism in the baby,
- you are in the a few days before or immediately after your monthly period,
- you have a disease of the kidney,
- you suffer from an accumulation of fluid in your body,
- you plan to have an examination of the thyroid,
- you are over 65 years old,
- you have problems with swelling in your lymph nodes.
Other warnings you should know about:
- A decrease in how well your kidneys work
- Existing kidney problems to get worse
- An increase in thyroid gland volume (goitre)
- Liver damage which can make your liver not work properly. This can cause side effects such as accumulation of fluid in the abdomen (ascites), not enough blood supply in the liver (hepatic infarction), changes in the level of consciousness possibly associated with other neurological symptoms (hepatic encephalopathy),
- An inflammation of the Fallopian tubes or of the peritoneum (lining of the stomach and pelvis),
- A temporary fever following hysterosalpingography (X-ray test to see the uterus and fallopian tubes) , with pain in the pelvic area is often noted as well as the possibility of salpingitis (inflammation of fallopian tubes) or pelvioperitonitis (inflammation of peritonium) if there is a latent state of infection,
- Small amounts of LIPIODOL ULTRA FLUID may enter into the blood supply and end up in other parts of the body such as blood vessels or arteries. This can cause serious reactions such as pulmonary, cerebral, and skin embolisms (Please see symptoms of these side effects in the Serious side effects and what to do about them table below). Your healthcare professional may monitor your symptoms after your X-ray test.
It can also cause:
- 1.
Thyroid dysfunction
- • Hyperthyroidism: an over-active thyroid gland
- • Hypothyroidism: an under-active thyroid gland
- • Thyroiditis: inflammation of the thyroid gland
- 2.
Allergic Disorders including hypersensitivity, anaphylactic or anaphylactoid reactions
These are uncommon and can be mild to severe including death. Most allergic disorders occur within 30 minutes. Reactions can also occur for up to several days. Your doctor should discuss symptoms of delayed allergic reactions with you.
- 3.
Cerebral Embolism and Blockages to Other Organs
Blockage of certain blood vessels in the brain
- 4.
Pulmonary Embolism
Blockage of certain blood vessels in the lung. It usually occurs right away but can be delayed for hours to days. It may result in excess fluid accumulation in and around the lung, critical respiratory failure, inflammation of the lungs.
- 5.
Worsening Chronic Liver Disease
Disease of the liver which lasts over a period of six months. It can cause heart problems, infection, irreversible liver damage and death.
- 6. Lymphoedema Aggravation
An accumulation of fluid in a body part. It is caused by a block of the lymph flow
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with LIPIODOL ULTRA FLUID:
- beta-blockers, diuretics, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers: these are drugs to treat eye disease, heart disease or high blood pressure,
- interleukin II drugs: These are drugs to treat cancer or to reinforce your immune system, i.e. your internal defence system,
- metformin: Drugs to treat diabetes. Your doctor should stop this drug 48 hours before the exam. It can be restarted 2 days after the exam,
- drugs that may cause damage to the kidney.
How to take LIPIODOL ULTRA FLUID:
Your doctor will prepare and inject this product before the exam. The route and method of injection depend on the reason the drug is being used.
Usual dose:
These depend on the reasons why LIPIODOL ULTRA FLUID is being used.
Your doctor will determine the dose to inject.
Overdose:
If you think you, or a person you are caring for, have taken too much LIPIODOL ULTRA FLUID, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Possible side effects from using LIPIODOL ULTRA FLUID:
These are not all the possible side effects you may have when taking LIPIODOL ULTRA FLUID. If you experience any side effects not listed here, tell your healthcare professional.
Side effects can include:
- Shortness of breath and cough
- Injection site pain and redness
- LIPIODOL ULTRA FLUID can cause abnormal blood test results. Your doctor will decide when to preform blood tests and will interpret the results.
- LIPIODOL ULTRA FLUID may interfere with thyroid diagnostic tests. It can cause changes to how the thyroid gland works. You may need to have a blood test to check the thyroid gland before using it. Thyroid blood test results can be affected for up to two years after taking LIPIODOL ULTRA FLUID.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
Thyroid Dysfunction: Hypothyroidism: fatigue,increased sensitivity to cold, constipation, dry skin, weight gain, puffy face, hoarseness, muscle weakness, slowed heart rate, depression, impaired memory Hyperthyroidism: difficulty concentrating, frequent bowel movements, goiter (visibly enlarged thyroid gland) or thyroid nodules, hair loss, hand tremor, heat intolerance, increased sweating, nervousness, weight loss, high blood pressure, bulging eyes Thyroiditis: feeling of fullness or pain in the neck, other symptoms similar to those of hypothyroidism or hyperthyroidism | |||
| Nausea, vomiting, diarrhoea, inflammation of the pancreas and gallbladder causing abdominal pain and fever, accumulation of bile in the abdomen (biloma) causing abdominal pain | |||
| Fever, general pain throughout your body and/or pain in the pelvis (lower abdomen) | |||
| Granuloma: pain or tenderness in the lower abdominal area, vaginal infection | |||
| Hepatic vein thrombosis: vomiting blood, black stools, enlarged spleen, swelling of lower limbs, abdominal pain (mainly in the upper right part of the abdomen), jaundice (yellowing of the skin and eyes). | |||
| Allergic Disorder: rash or hives, flushing, pimples, itching and/or sudden swelling of the face, eyelids, lips, tongue or throat. Difficulty breathing or swallowing, wheezing, plugged nose, sneezing, coughing, dry throat, fever, chills, nausea, vomiting, diarrhoea, low blood pressure, and joint pain. Decreased urine output. | |||
| Cerebral Embolism and Blockages to Other Organs: severe headache, blurred vision, fainting, loss of consciousness, drowsiness, convulsion, confusion. | |||
| Pulmonary Embolism: shortness of breath, fast or difficult breathing, cough. | |||
| Lymphoedema Aggravation: swelling, heaviness, fullness and aching of body parts. Full or heavy sensation in the limb(s), tightness of the skin or tissue, decreased flexibility in the hand/wrist/foot/ankle, difficulty fitting into clothing in one specific area, or ring/wristwatch/bracelet tightness | |||
| Worsening Chronic Liver Disease: fever, chills, swollen or painful abdomen. Jaundice with yellow color to skin, eyes and dark urine, pus-filled mass inside the liver. Increased blood pressure, headache and dizziness. | |||
| Retinal Vein Thrombosis (Blood clot in the eye): sudden loss of all or part of your vision or double vision. | |||
| Salivary Duct Inflammation: Abnormal or foul tastes, decreased ability to open the mouth, dry mouth, fever, mouth or facial pain, especially when eating, swelling of the face | |||
Decreased kidney Function: Fatigue, lethargy, weakness, swelling, shortness of breath and confusion | |||
Worsening existing asthma: Cough, wheezing, shortness of breath, chest pain or pressure | |||
| Skin damage (necrosis) | |||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Protect from light. Store at room temperature up to 30°C.
Keep out of reach and sight of children.
If you want more information about LIPIODOL ULTRA FLUID:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website www.methapharm.com; or by calling 1-800-287-7686 ext. 7840.
Date of Revision: MAR 12, 2026