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Gadodiamide (Injection) (Injectable)

(OMNISCAN)
Gadodiamide (By injection)
Gadodiamide (gad-oh-DYE-a-mide)Used in magnetic resonance imaging (MRI) scans. Helps your doctor to see images of your brain, spine, chest, stomach, hip area, and other parts of your body. This medicine is a gadolinium-based contrast agent (GBCA).
Omniscan , Omniscan Novaplus

When This Medicine Should Not Be Used:
You should not receive this medicine if you have had an allergic reaction to gadodiamide or other gadolinium-based contrast agents, or if you have severe kidney problems.

How to Use This Medicine:
Injectable

  • 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.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.


Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, asthma, diabetes, high blood pressure, severe infection, seizures, or a history of an allergic reaction to any contrast agent. Tell your doctor if you have any allergic respiratory diseases.
  • The risk of having a very serious disease called nephrogenic systemic fibrosis (NSF) is increased in patients with severe kidney disease. Even if you have severe kidney problems, your doctor may decide that it is still important to use this medicine. 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 after you get the injection. These may be symptoms of nephrogenic systemic fibrosis.
  • 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.
  • Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Bloody, black, or tarry stools.
  • Change in how much or how often you urinate, or blood in your urine.
  • Cold feeling, seizures, or tremors.
  • Fast, slow, pounding, or uneven heartbeat.
  • Fever.
  • Lightheadedness, dizziness, or fainting.
  • Muscle stiffness or weakness, stiff joints or trouble moving, or deep bone pain.
  • Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
  • Severe headache.
  • Severe rash or redness on your skin.
  • Shortness or breath or troubled breathing.
  • Skin rash, swelling, hardness, tightness, burning, itching, or red or dark patches.
  • Swelling in your hands, ankles, or feet.
  • Warmth or redness in your face, neck, arms, or upper chest.

If you notice these less serious side effects, talk with your doctor:

  • Bad taste in your mouth.
  • Dry mouth, nausea, vomiting, diarrhea, or stomach pain.
  • Headache.
  • Increased sweating.
  • Pain, itching, burning, swelling, or a lump under your skin where the needle is placed.
  • Rash or itching skin.
  • Ringing in the ears or blurred vision.
  • Stuffy or runny nose.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088