1 vial with 30 ml contains 18141.6 mg gadobutrol. 1 bottle with 65 ml contains 39306.8 mg gadobutrol. The other ingredients are calcobutrol sodium (see end of section 2), trometamol, hydrochloric acid 1N and water for injections. Gadovist is a clear, colourless to pale yellow solution for injection.
Food and Drug Administration (.gov)
GADOVIST Side Effects
What is the most important information I should know about Gadavist (Gadobutrol)?
Gadobutrol can cause a life-threatening condition in people with advanced kidney disease. Your doctor may check your kidney function before you receive this medicine.
Gadobutrol can stay in your body for months or years after you receive this medicine. It is not known whether this could cause any health problems in people with normal kidneys. Tell your doctor if you have had repeated scans with a contrast agent, and provide the date of your last scan.
You should not receive gadobutrol if you are allergic to it.
Tell your doctor if you have ever had:
- kidney disease (or if you are on dialysis);
- any type of reaction to a contrast agent;
- high blood pressure;
- liver disease;
- asthma, hay fever, food or drug allergies;
- an injury, surgery, or severe infection; or
- if you are over 60 years old.
What are the side effects of Gadavist (Gadobutrol)?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects of gadobutrol may occur up to several days after injection.
Gadobutrol can cause a life-threatening condition in people with advanced kidney disease. Call your doctor right away if you have any symptoms of this condition, such as:
- burning, itching, swelling, scaling, and tightening or hardening of your skin;
- muscle weakness;
- joint stiffness in your arms, hands, legs, or feet;
- deep bone pain in your ribs or your hips;
- trouble moving; or
- skin redness or discoloration.
Also call your doctor at once if you have:
- kidney problems–little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.
Common side effects may include:
- nausea; or
This is not a complete list of side effects and others may occur.