Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Omniscan

Descriptions


Gadodiamide is a magnetic resonance imaging (MRI) contrast agent. Contrast agents are used to help create a clear picture of the body during MRI scans. MRI scans are a special kind of diagnostic procedure. They use magnets and computers to create images or “pictures” of certain areas inside the body. Unlike x-rays, they do not involve ionizing radiation. Gadodiamide is a gadolinium-based contrast agent (GBCA).

Gadodiamide is given by injection before MRI to help diagnose problems in the brain, spine, chest, stomach, hip area, and other parts of your body.

This medicine is to be used only by or under the direct supervision of a doctor.

This product is available in the following dosage forms:

  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gadodiamide in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gadodiamide in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving gadodiamide.

Pregnancy

Information about this gadodiamide-intravenous-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma or allergies, history of or
  • Infection, severe or
  • Kidney problems, mild to moderate or
  • Seizures, history of—Use with caution. May cause side effects to become worse.
  • Diabetes or
  • Hypertension (high blood pressure)—Use with caution. May increase risk for kidney problems.
  • Kidney problems, severe (recent or long-term)—Should not be used in patients with this condition.

Proper Use

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins just before you have an MRI scan.

Precautions

Check with your doctor right away if you or your child have burning or itching of the skin; red or dark patches on the skin; skin swelling, hardening, or tightening; joint stiffness; limited range of motion in the arms and legs; pain that is deep in the hip bone or ribs; or muscle weakness. These may be symptoms of a very serious disease called nephrogenic systemic fibrosis (NSF).

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor or nurse right away if you or your child have cold, clammy skin; confusion; dizziness; lightheadedness; a skin rash; itching; sweating; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you receive the medicine.

Make sure your doctor knows that you or your child have used this medicine. This medicine may affect the results of certain medical tests (e.g., serum iron or calcium).

Side Effects

Along with its needed effects, a medicine 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:

Less common or rare

  1. Agitation
  2. bloody, black, or tarry stools
  3. blurred vision
  4. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  5. change in consciousness
  6. changes in skin color
  7. chest pain or discomfort
  8. clumsiness or unsteadiness
  9. confusion
  10. cough
  11. decreased urine output
  12. depression
  13. difficult or labored breathing
  14. difficulty controlling your bladder or bowels
  15. difficulty swallowing
  16. difficulty walking
  17. dilated neck veins
  18. dizziness
  19. extreme fatigue
  20. fainting
  21. fast, slow, or irregular heartbeat
  22. feeling faint, dizzy, or lightheaded
  23. feeling of warmth or heat
  24. feeling sad or depressed
  25. feeling unusually cold
  26. flushing or redness of the skin, especially on the face and neck
  27. forgetful
  28. general feeling of discomfort or illness
  29. headache
  30. headache, severe and throbbing
  31. hives
  32. hostility
  33. irregular breathing
  34. irritability
  35. itching
  36. lethargy
  37. loss of bladder control
  38. loss of consciousness
  39. muscle cramps
  40. muscle twitching
  41. nausea
  42. numbness or tingling in your arms, legs, or face
  43. pain or discomfort in the arms, jaw, back, or neck
  44. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  45. rapid weight gain
  46. redness of the face, neck, arms, and occasionally, upper chest
  47. seizures
  48. shakiness and unsteady walk
  49. shakiness in the legs, arms, hands, or feet
  50. shivering
  51. shortness of breath
  52. skin rash
  53. slurred speech or problems swallowing
  54. stupor
  55. sudden sweating
  56. sweating
  57. swelling of the face, fingers, feet, ankles, or lower legs
  58. tenderness
  59. tightness in the chest
  60. total body jerking
  61. trembling or shaking of the hands or feet
  62. troubled breathing
  63. unsteadiness, trembling, or other problems with muscle control or coordination
  64. unusual tiredness or weakness
  65. vomiting
  66. weight gain
  67. wheezing

Incidence not known

  1. Burning or itching of the skin
  2. joint stiffness
  3. limited range of motion in the arms and legs
  4. muscle weakness
  5. pain that is deep in the hip bone or ribs
  6. partial or slight paralysis
  7. red or dark patches on the skin
  8. skin swelling, hardening, or tightening

Some side effects 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 or rare

  1. Abdominal or stomach pain
  2. bad, unusual, or unpleasant (after) taste
  3. belching
  4. bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  5. bloated or full feeling
  6. change in taste
  7. changes in vision
  8. continuing ringing or buzzing or other unexplained noise in the ears
  9. diarrhea
  10. difficulty with moving
  11. dry mouth
  12. excess air or gas in the stomach
  13. hearing loss
  14. hives or welts
  15. increased sweating
  16. joint pain
  17. muscle pains or stiffness
  18. redness of the skin
  19. runny nose
  20. sneezing
  21. stuffy nose
  22. swollen joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.