Prohance Side Effects
Generic name: gadoteridol
Medically reviewed by Drugs.com. Last updated on Jul 29, 2024.
Note: This document provides detailed information about Prohance Side Effects associated with gadoteridol. Some dosage forms listed on this page may not apply specifically to the brand name Prohance.
Applies to gadoteridol: intravenous solution.
Important warnings
This medicine can cause some serious health issues
Intravenous route (solution)
Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) in patients with impaired elimination of the drugs.
Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities.
NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs.
The risk for NSF appears highest among patients with chronic, severe renal insufficiency (GFR less than 30 mL/min/1.73 m(2)), or acute kidney injury.
Screen 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), estimate the GFR through laboratory testing.
For patients at highest risk for NSF, do not exceed the recommended gadoteridol dose and allow a sufficient period of time for elimination of the drug from the body prior to readministration.
Precautions
It is very important that your doctor check your 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.
Check with your doctor or nurse right away if you or your child have burning or itching of the skin, deep bone pain in the hips or ribs, joint stiffness, a limited range of motion in the arms and legs, muscle weakness, red or dark patches on the skin of the arms or legs, or skin swelling, hardening, or tightening within the first few days or weeks after you receive this medicine. These may be symptoms of a very serious disease called nephrogenic systemic fibrosis (NSF).
This medicine may increase your risk of having acute kidney injury (AKI). This has occurred in patients with severe kidney problems, and the risk is increased with high doses of gadoteridol (the active ingredient contained in Prohance)
This medicine may cause serious allergic reactions, including 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 chest pain, cold, clammy skin, confusion, dizziness, lightheadedness, a skin rash, itching, sweating, swelling of the face, tongue, and throat, or trouble breathing after receiving the medicine.
This medicine contains a metal called gadolinium, which can stay in your body (including the brain, bones, skin, kidneys, liver, spleen) for a long time (several months to years). Talk to your doctor if you have concerns.
Serious side effects of Prohance
Along with its needed effects, gadoteridol 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 gadoteridol:
Rare side effects
- absence of or decrease in body movement
- arm, back, or jaw pain
- bluish color of the fingernails, lips, skin, palms, or nail beds
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain, discomfort, or tightness
- confusion
- cough
- decreased awareness or responsiveness
- difficult or labored breathing
- difficulty swallowing
- dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
- false feeling of insects crawling on the skin
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth
- fever
- general feeling of discomfort or illness
- headache, severe and throbbing
- hives, itching, skin rash
- hoarseness
- increased salivation
- loss of bladder control
- loss of consciousness
- low blood pressure or pulse
- nausea
- nervousness
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the face, neck, arms, and occasionally, upper chest
- seizures
- shakiness in the legs, arms, hands, or feet
- slow, fast, or irregular breathing
- spasm of the throat
- sweating
- trembling or shaking of the hands or feet
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Incidence not known
- agitation
- burning, dry, or itching eyes
- coughing that sometimes produces a pink frothy sputum
- decreased or uncontrolled urination
- difficult, fast, noisy breathing
- discharge, excessive tearing
- incoordination
- lack or loss of strength
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- muscle weakness
- numbness, tingling, pain, or weakness in the hands or feet
- paralysis or severe weakness of the legs
- slow heartbeat
- skin lesions (plaques)
- stiffness of the arms or legs
- swelling in the legs and ankles
- uncontrolled bowel movements
- uncontrolled movements of the body
Other side effects of Prohance
Some side effects of gadoteridol 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
- anxiety
- bad, unusual, or unpleasant (after) taste
- bleeding gums
- 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
- continuing ringing or buzzing or other unexplained noise in the ears
- diarrhea
- dry mouth
- ear discomfort
- hearing loss
- irritation in the mouth
- loss of coordination in the arms
- mouth ulcers
- rash with flat lesions or small raised lesions on the skin
- redness and swelling of the gums
- runny or stuffy nose
- sneezing
- stomach cramps
- tingling sensation in the throat
- voice changes
- vomiting
- watery eyes
For healthcare professionals
Applies to gadoteridol: intravenous solution.
General adverse events
General side effects have included facial edema, neck rigidity, pain, chest pain, fever, tingling sensation in throat, laryngismus, flushed feeling, vasovagal reaction, and generalized edema.[Ref]
Respiratory
Respiratory side effects have included dyspnea, rhinitis, cough, apnea, and wheezing.[Ref]
Other
Other side effects have included voice alteration; transitory deafness and tinnitus.[Ref]
Nervous system
Nervous system side effects have included headache, anxiety, dizziness, paresthesia, mental status decline, loss of coordination in arm, staring episodes, seizure, syncope, stupor, tremor, tingling sensation in extremities and digits, and loss of consciousness.[Ref]
Hypersensitivity
Hypersensitivity side effects have included anaphylactoid reactions rarely resulting in death.[Ref]
Dermatologic
Dermatologic side effects have included pruritus, rash, macular papular rash, urticaria, hives, itching, sweating, and cyanosis.[Ref]
Gastrointestinal
Gastrointestinal side effects have included edematous and/or itching tongue, gingivitis dry mouth, loose bowel, vomiting, abdominal cramps, increased salivation, and dysphagia.[Ref]
Cardiovascular
Cardiovascular side effects have included prolonged P-R Interval, hypotension, elevated heart rate, A-V nodal rhythm, cardiac arrest, bradycardia, hypertension, and death in association with pre-existing cardiovascular disorders.[Ref]
Genitourinary
Genitourinary side effects have included urinary incontinence.[Ref]
Local
Local side effects have included pain at injection site and injection site reaction.[Ref]
Ocular
Ocular side effects have included watery eyes.
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References
1. (2001) "Product Information. ProHance (gadoteridol)." Bracco Diagnostics Inc
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Prohance 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.