Applies to gadobenate dimeglumine: intravenous solution.
Warning
Intravenous route (Solution)
Nephrogenic Systemic Fibrosis (NSF)Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among 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-contrasted 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 kidney disease (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 glomerular filtration rate (GFR) through laboratory testing.For patients at highest risk for NSF, do not exceed the recommended gadobenate dimeglumine dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration
Serious side effects
Along with its needed effects, gadobenate dimeglumine 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 gadobenate dimeglumine:
Rare
- Anxiety
- back pain
- black, tarry stools
- bladder pain
- bloody or cloudy urine
- blue lips and fingernails
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- chills
- confusion
- cough
- coughing that sometimes produces a pink frothy sputum
- dark urine
- decreased urination
- deep or fast breathing with dizziness
- difficult or labored breathing
- difficult, burning, or painful urination
- difficult, fast, or noisy breathing
- difficulty with breathing or swallowing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- excessive muscle tone
- fainting
- fast, slow, or irregular heartbeat
- fever
- frequent urge to urinate
- general feeling of discomfort or illness
- headache
- hives, itching, skin rash
- inability to move the legs or arms
- increased sweating
- lower back or side pain
- muscle stiffness, tension, or tightness
- nausea
- nervousness
- numbness of the feet, hands, and around the mouth
- pain in the shoulders, arms, jaw, or neck
- pain or redness at the injection site
- pale skin at the injection site
- paralysis of one side of the body
- pounding heartbeat
- pounding in the ears
- problems with speech or speaking
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- reddening of the skin, especially around the ears
- seizures
- shakiness in the legs, arms, hands, or feet
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sugar in the urine
- sweating
- swelling in the legs and ankles
- swelling of the eyes, face, or inside of the nose
- swollen glands
- tightness in the chest
- tiredness
- trembling or shaking of the hands or feet
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
Incidence not known
- Lack or loss of strength
- loss of consciousness
- peeling of the skin
- skin lesions
Other side effects
Some side effects of gadobenate dimeglumine 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
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, rash, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- feeling hot
Rare
- Bad, unusual, or unpleasant (after) taste
- belching
- blurred or loss of vision
- change in sense of smell
- change in taste
- continuing ringing or buzzing or other unexplained noise in the ears
- decreased awareness or responsiveness
- diarrhea
- difficulty having a bowel movement
- difficulty with moving
- disturbed color perception
- double vision
- dry mouth
- ear pain
- feeling unusually cold
- halos around lights
- hearing loss
- heartburn
- indigestion
- joint pain
- lack or loss of strength
- loss of bowel control
- muscle aches, spasms, or cramps
- night blindness
- overbright appearance of lights
- redness of the eye
- severe sleepiness
- shivering
- stomach discomfort or upset
- stuffy nose
- swollen joints
- tunnel vision
- vomiting
For Healthcare Professionals
Applies to gadobenate dimeglumine: intravenous solution.
Cardiovascular
Cardiovascular side effects have included hypertension, vasodilatation, and tachycardia.[Ref]
Gastrointestinal
Gastrointestinal side effects have included nausea, vomiting, and diarrhea.[Ref]
Hematologic
Hematologic side effects have included anemia.[Ref]
Nervous system
Nervous system side effects have included headache, paresthesia, and dizziness.[Ref]
Dermatologic
Dermatologic side effects have included rash.[Ref]
General
General side effects have included taste perversion.[Ref]
Local
Local side effects have included pain and injection site reactions.[Ref]
Hypersensitivity
Hypersensitivity side effects have included anaphylactic and anaphylactoid reactions involving cardiovascular, respiratory and/or cutaneous manifestations which ranged from mild to severe. Some patients experienced circulatory collapse and died. In most cases, initial symptoms occurred within minutes of administration and resolved with prompt emergency treatment.
