Gadodiamide Side Effects
Medically reviewed by Drugs.com. Last updated on May 22, 2024.
Applies to gadodiamide: intravenous solution.
Important warnings
This medicine can cause some serious health issues
Intravenous route (solution)
Gadodiamide is not for intrathecal use.
Inadvertent intrathecal use has caused convulsions, coma, and sensory and motor neurologic deficits.
Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs Avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast enhanced MRI.
NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs.
Do not administer to patients with chronic, severe kidney disease (GFR less than 30 mL/min/1.73 m(2)) or acute kidney injury.
Screen all patients 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 recommended dose and allow a sufficient time period for elimination prior to readministration.
Precautions
It is very important that your doctor check you or your child's progress while you are receiving this medicine and during the MRI scan to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
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 receive this medicine. Check with your doctor right away if you or your child have burning, swelling, tightening, or itching of the skin, red or dark patches on the skin, 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 NSF.
This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor or nurse right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the medicine.
This medicine contains a metal called gadolinium, which can stay in your body (including the brain, bones, skin) for a long time (several months to years). Talk to your doctor if you have concerns.
This medicine may increase your risk of having acute kidney injury requiring dialysis. This is more likely in patients with a history of kidney problems or in patients receiving increasing doses of gadoterate injection. Talk to your doctor about this risk.
Tell your doctor right away if you or your child have mild, burning pain, feeling of warmth or coldness, peeling of the skin, redness, or swelling at the injection site.
Make sure your doctor knows that you or your child have used this medicine. This medicine may affect the results of certain medical tests (eg, serum iron or calcium).
Serious side effects of gadodiamide
Along with its needed effects, gadodiamide 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 gadodiamide:
Rare side effects
- 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 awareness or responsiveness
- decreased urine output
- depression
- difficult or labored breathing
- difficulty controlling your bladder or bowels
- difficulty swallowing
- difficulty walking
- dilated neck veins
- dizziness
- extreme tiredness or weakness
- fainting
- fast, slow, or irregular heartbeat
- 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, itching, skin rash
- hostility
- irregular breathing
- irritability
- loss of bladder control
- loss of consciousness
- muscle cramps or 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
- severe sleepiness
- shakiness and unsteady walk
- shakiness in the legs, arms, hands, or feet
- shivering
- slurred speech or problems swallowing
- 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
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- vomiting
- weight gain
Incidence not known
- burning or itching of the skin
- decreased or uncontrolled urination
- incoordination
- joint stiffness
- lack or loss of strength
- limited range of motion in the arms and legs
- muscle pain, spasms, stiffness, or weakness
- pain that is deep in the hip bone or ribs
- paralysis or severe weakness of the legs
- partial or slight paralysis
- red or dark patches on the skin
- skin swelling, hardening, or tightening
- small, abnormal patch or build-up
- stiffness of the arms or legs
- uncontrolled movements of the body
Other side effects of gadodiamide
Some side effects of gadodiamide 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 side effects
- 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
- increased sweating
- joint pain or swelling
- runny nose
- sneezing
- stomach pain
- stuffy nose
For healthcare professionals
Applies to gadodiamide: injectable solution.
General adverse events
General side effects have included fever, hot flushes, rigors, fatigue, malaise, pain, and syncope.[Ref]
Nervous system
Nervous system side effects have included headache, tinnitus, taste loss, taste perversion, and dizziness. Convulsions including grand mal, ataxia, abnormal coordination, paresthesia, tremor, aggravated multiple sclerosis (characterized by sensory and motor disturbances), and aggravated migraine have been reported.[Ref]
Gastrointestinal
Gastrointestinal side effects have included nausea, abdominal pain, diarrhea, eructation, dry mouth, vomiting, and melena.[Ref]
Hypersensitivity
Hypersensitivity side effects have included anaphylactoid reactions (characterized by cardiovascular, respiratory, and cutaneous symptoms).[Ref]
Cardiovascular
Cardiovascular side effects have included cardiac failure, arrhythmia and myocardial infarction. Also reported include vasodilation, flushing, chest pain, deep thrombophlebitis, and rarely, arrhythmia and myocardial infarction resulting in death in patients with ischemic heart disease.[Ref]
Hepatic
Hepatic side effects have included abnormal hepatic function.[Ref]
Respiratory
Respiratory side effects have included rhinitis and dyspnea.[Ref]
Ocular
Ocular side effects have included abnormal vision.[Ref]
Renal
Renal side effects have included acute reversible renal failure.[Ref]
Musculoskeletal
Musculoskeletal side effects have included arthralgia and myalgia.[Ref]
Dermatologic
Dermatologic side effects have included pruritus, rash, erythematous rash, increased sweating, and urticaria.[Ref]
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References
1. (2004) "Product Information. Omniscan (gadodiamide)." Novation
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Further information
Gadodiamide side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.