Applies to gadoxetate disodium: intravenous solution.
Warning
Intravenous route (Solution)
Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) in patients with impaired elimination of the drugs. Patients with chronic, severe renal insufficiency (GFR less than 30 mL/min/1.73 m(2)) or acute kidney injury are at greatest risk. NSF may lead to fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Avoid use of GBCAs in patients with impaired elimination unless use is essential and other modalities (eg, non-contrast enhanced MRI) are not available. Screen for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, age greater than 60 years, hypertension, or diabetes), perform lab testing to estimate the GFR. For patients with the highest NSF risk, do not exceed the recommended dose and allow enough time for drug elimination prior to any readministration.
Serious side effects of Gadoxetate disodium
Along with its needed effects, gadoxetate disodium 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 while taking gadoxetate disodium:
Rare
- Blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or tightness
- chills
- dizziness
- fainting
- fast, slow, or irregular heartbeat
- feeling hot
- headache
- inability to sit still
- need to keep moving
- nervousness
- pounding in the ears
- restlessness
- shakiness in the legs, arms, hands, or feet
- trembling or shaking of the hands or feet
- trouble breathing
Incidence not known
- Cold, clammy skin
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, weak pulse
- lightheadedness
- restlessness
- sneezing
- stuffy or runny nose
- sweating
- unusual tiredness or weakness
Other side effects of Gadoxetate disodium
Some side effects of gadoxetate disodium 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:
Rare
- Back pain
- 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
- change in sense of smell
- change in taste
- dry mouth
- feeling of constant movement of self or surroundings
- feeling of warmth
- general feeling of discomfort or illness
- increased sweating
- increased watering of the mouth
- itching
- loss of taste
- nausea
- rash with flat lesions or small raised lesions on the skin
- redness of the face, neck, arms, and occasionally, upper chest
- sensation of spinning
- vomiting
For Healthcare Professionals
Applies to gadoxetate disodium: intravenous solution.
Cardiovascular
Cardiovascular side effects have included chest pain, bundle branch block, increased blood pressure, and flushing.[Ref]
Nervous system
Nervous system side effects have included headache, akathisia, dizziness, parosmia, vertigo, tremor, akathisia, and dysgeusia.[Ref]
Respiratory
Respiratory side effects have included dyspnea and respiratory distress.[Ref]
Gastrointestinal
Gastrointestinal side effects have included dry mouth, oral discomfort, salivary hypersecretion, nausea, and vomiting.[Ref]
General
General side effects have included feeling hot, chills, discomfort, fatigue and malaise.[Ref]
Dermatologic
Dermatologic side effects have included maculopapular rash, hyperhidrosis, rash, and pruritus.[Ref]
Local
Local side effects have included injection site reactions (pain, burning, coldness, extravasation).[Ref]
