Name: Omniscan

Precautions While Using Omniscan

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).

Omniscan 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
  • Agitation
  • bloody, black, or tarry stools
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in consciousness
  • changes in skin color
  • chest pain or discomfort
  • clumsiness or unsteadiness
  • confusion
  • cough
  • decreased urine output
  • depression
  • difficult or labored breathing
  • difficulty controlling your bladder or bowels
  • difficulty swallowing
  • difficulty walking
  • dilated neck veins
  • dizziness
  • extreme fatigue
  • fainting
  • fast, slow, or irregular heartbeat
  • feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • feeling sad or depressed
  • feeling unusually cold
  • flushing or redness of the skin, especially on the face and neck
  • forgetful
  • general feeling of discomfort or illness
  • headache
  • headache, severe and throbbing
  • hives
  • hostility
  • irregular breathing
  • irritability
  • itching
  • lethargy
  • loss of bladder control
  • loss of consciousness
  • muscle cramps
  • muscle twitching
  • nausea
  • numbness or tingling in your arms, legs, or face
  • pain or discomfort in the arms, jaw, back, or neck
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • redness of the face, neck, arms, and occasionally, upper chest
  • seizures
  • shakiness and unsteady walk
  • shakiness in the legs, arms, hands, or feet
  • shivering
  • shortness of breath
  • skin rash
  • slurred speech or problems swallowing
  • stupor
  • sudden sweating
  • sweating
  • swelling of the face, fingers, feet, ankles, or lower legs
  • tenderness
  • tightness in the chest
  • total body jerking
  • trembling or shaking of the hands or feet
  • troubled breathing
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual tiredness or weakness
  • vomiting
  • weight gain
  • wheezing
Incidence not known
  • Burning or itching of the skin
  • joint stiffness
  • limited range of motion in the arms and legs
  • muscle weakness
  • pain that is deep in the hip bone or ribs
  • partial or slight paralysis
  • red or dark patches on the skin
  • 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
  • Abdominal or stomach pain
  • bad, unusual, or unpleasant (after) taste
  • belching
  • 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
  • bloated or full feeling
  • change in taste
  • changes in vision
  • continuing ringing or buzzing or other unexplained noise in the ears
  • diarrhea
  • difficulty with moving
  • dry mouth
  • excess air or gas in the stomach
  • hearing loss
  • hives or welts
  • increased sweating
  • joint pain
  • muscle pains or stiffness
  • redness of the skin
  • runny nose
  • sneezing
  • stuffy nose
  • 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.

Dosage Forms and Strengths

Sterile aqueous solution for intravenous injection; 287 mg/mL.