Gadovist (Gadobutrol)
Gadolinium-Based Contrast Agent for MRI Diagnostics
Quick Facts About Gadovist
Key Takeaways About Gadovist
- Macrocyclic stability: Gadovist uses a macrocyclic chelate structure that holds gadolinium ions more securely, reducing the risk of free gadolinium release compared to linear agents
- Broad diagnostic applications: Approved for contrast-enhanced MRI of the central nervous system, blood vessels (MR angiography), liver, kidneys, and whole-body imaging in adults and children of all ages
- Kidney function screening required: All patients should be assessed for kidney disease before administration, as severe renal impairment increases the risk of nephrogenic systemic fibrosis (NSF)
- 30-minute observation period: Patients must be monitored for at least 30 minutes after injection because allergic and anaphylactic reactions, while rare, can occur
- High concentration advantage: At 1.0 mmol/ml, Gadovist has the highest gadolinium concentration among approved GBCAs, allowing smaller injection volumes and high-quality imaging
What Is Gadovist and What Is It Used For?
Gadovist (gadobutrol) is a gadolinium-based contrast agent used to enhance the quality of MRI scans. It is injected intravenously and helps radiologists see abnormal structures, distinguish healthy tissue from diseased tissue, and determine whether lesions in the liver or kidneys are benign or malignant.
Magnetic resonance imaging (MRI) is a medical imaging technique that uses powerful magnets and radio waves to create detailed pictures of organs and tissues inside the body. Unlike X-rays or CT scans, MRI does not use ionising radiation, making it a preferred choice for many diagnostic scenarios. However, certain structures or abnormalities may be difficult to see on standard (unenhanced) MRI scans. This is where contrast agents like Gadovist play a critical role.
Gadovist belongs to the class of gadolinium-based contrast agents (GBCAs). When injected into a vein, gadobutrol distributes through the bloodstream and accumulates in areas of the body where blood vessels are particularly active or where the blood-brain barrier is disrupted. The gadolinium in Gadovist alters the magnetic properties of surrounding water molecules, causing these areas to appear brighter on T1-weighted MRI images. This enhancement allows physicians to detect and characterise lesions that would otherwise be invisible or poorly defined.
Gadovist is approved for use in a wide range of clinical indications. It is commonly used for contrast-enhanced MRI of the brain and spinal cord, where it helps identify tumours, inflammation, infections, and demyelinating diseases such as multiple sclerosis. In magnetic resonance angiography (MRA), Gadovist enables detailed visualisation of blood vessels throughout the body, helping to detect aneurysms, stenoses, and other vascular abnormalities. The agent is also indicated for the evaluation of focal liver and kidney lesions, assisting in the differentiation between benign and malignant masses.
One of the distinguishing features of Gadovist is its macrocyclic molecular structure. In this configuration, the gadolinium ion is enclosed within a ring-shaped (cage-like) chelate molecule. This design provides high thermodynamic and kinetic stability, meaning the gadolinium is held very securely and is far less likely to be released from the chelate. This is a significant safety advantage, as free gadolinium ions are toxic. The European Medicines Agency (EMA) and other regulatory bodies have specifically recognised the superior stability of macrocyclic GBCAs compared to their linear counterparts.
How Does Gadovist Work?
MRI creates images based on the behaviour of hydrogen atoms (protons) in water molecules within the body when exposed to a strong magnetic field and radiofrequency pulses. Different tissues have different relaxation times (T1 and T2), which determine their appearance on MRI images.
Gadobutrol is a paramagnetic substance. When injected intravenously, it shortens the T1 relaxation time of nearby water protons, causing tissues where the contrast agent has accumulated to produce a stronger signal on T1-weighted sequences. The result is increased brightness (enhancement) in these areas, dramatically improving the contrast between normal and abnormal tissues.
Gadovist has high relaxivity (r1 = 5.2 L/mmol/s at 1.5 Tesla), which means it produces particularly strong signal enhancement per unit of gadolinium. Combined with its 1.0 mmol/ml concentration – the highest among all approved GBCAs – this allows for compact injection volumes while maintaining excellent image quality. After injection, the MRI scan can begin immediately, and optimal enhancement for central nervous system lesions is typically achieved within approximately 15 minutes.
Gadovist is exclusively administered by healthcare professionals experienced in clinical MRI. It is given as a rapid intravenous injection (bolus) through a thin needle or cannula. The agent is intended solely for diagnostic purposes and is not a therapeutic medication.
What Should You Know Before Receiving Gadovist?
Before receiving Gadovist, your healthcare team must assess your kidney function and check for allergies or other conditions that could increase risk. Patients with severe kidney disease face a higher risk of nephrogenic systemic fibrosis (NSF), a serious and potentially life-threatening condition.
Contraindications
Gadovist must not be used if you have a known allergy (hypersensitivity) to gadobutrol or any of the other ingredients in the formulation. Although true allergies to gadolinium-based contrast agents are uncommon, they can range from mild skin reactions to severe anaphylaxis. If you have previously experienced any adverse reaction to a GBCA, you must inform your healthcare provider before the procedure.
Warnings and Precautions
Before receiving Gadovist, speak with your doctor if any of the following apply to you:
- You have or have had allergies (e.g. hay fever, hives) or asthma
- You have previously experienced a reaction to any contrast agent
- You have significantly impaired kidney function
- You have a condition affecting the brain that causes seizures, or any other central nervous system disorder
- You have a cardiac pacemaker, other implanted device, or metal clips containing iron in your body
NSF is a rare but serious condition that has been reported in association with certain gadolinium-based contrast agents, particularly in patients with acute or chronic severe kidney impairment (GFR <30 ml/min/1.73m²). NSF causes progressive thickening and hardening of the skin and may also affect internal organs including the lungs, liver, heart, and muscles. Patients undergoing liver transplantation are at particularly high risk because acute kidney failure is common in this group. All patients must be screened for kidney dysfunction before receiving Gadovist.
If you have severe kidney impairment, Gadovist should only be used after careful evaluation of the risk-benefit ratio by your doctor, and only when the diagnostic information is essential and cannot be obtained through non-contrast MRI. In such cases, the dose must not exceed 0.1 mmol/kg body weight, only a single dose should be given per examination, and repeat injections must not occur within 7 days.
Allergic-type reactions and other adverse reactions (including cardiovascular, respiratory, and skin manifestations) can occur after Gadovist administration. Serious reactions, including anaphylaxis, are possible though rare. Most reactions occur within 30 minutes of injection, which is why patients are observed after the procedure. However, delayed reactions have been reported hours to days after administration.
Patients aged 65 years and older may require a blood test to assess kidney function before Gadovist is administered, as renal clearance of the agent may be reduced in the elderly.
Neonates and Infants
Gadovist can be used in children of all ages, including newborns. However, because kidney function is not fully developed in neonates (up to 4 weeks old) and infants (up to 1 year old), the agent will only be used after careful consideration by the treating physician. In these patients, only a single dose should be given per examination, and repeat injections should not occur within 7 days.
Pregnancy and Breastfeeding
Gadobutrol can cross the placenta, and its effects on the developing baby are unknown. You must inform your doctor if you are or may be pregnant. Gadovist should not be used during pregnancy unless absolutely necessary and the potential benefit justifies the potential risk to the foetus.
If you are breastfeeding, your doctor will discuss with you whether to continue or interrupt breastfeeding for a period of 24 hours after receiving Gadovist. Only minimal amounts of gadobutrol pass into breast milk, and the risk to the nursing infant is considered very low. Nevertheless, the precautionary 24-hour interruption allows the agent to be largely eliminated from the body.
Sodium Content
Gadovist contains less than 23 mg sodium per dose (based on an average dose for a 70 kg person), meaning it is essentially sodium-free. This is relevant for patients on sodium-restricted diets.
Driving and Operating Machinery
Gadovist does not affect the ability to drive or operate machinery.
How Does Gadovist Interact with Other Drugs?
No significant drug interactions with Gadovist have been identified in clinical studies. However, you should always inform your healthcare provider about all medications you are taking, including prescription drugs, over-the-counter medicines, and herbal supplements.
Unlike many oral medications that are metabolised by liver enzymes, gadobutrol is not metabolised in the body. It is excreted unchanged through the kidneys by glomerular filtration. Because of this pharmacokinetic profile, Gadovist does not interact with the cytochrome P450 enzyme system or other common drug-metabolising pathways. This means it is unlikely to affect or be affected by other medications.
However, there are some considerations that healthcare providers keep in mind. Medications that affect kidney function – particularly nephrotoxic drugs – may indirectly influence the safety profile of Gadovist by impairing the body's ability to eliminate the contrast agent. Patients taking drugs known to reduce kidney function should be assessed carefully, and kidney function tests may be performed before administration.
No formal drug interaction studies have been conducted with gadobutrol. However, because the agent is eliminated entirely through renal excretion, any concomitant medication that significantly impairs glomerular filtration rate (GFR) may prolong the half-life of gadobutrol in the body. This is particularly relevant in patients already at risk for NSF.
Additionally, patients with epilepsy or a low seizure threshold should be monitored, as gadolinium-based contrast agents may rarely lower the seizure threshold. If such patients are also taking medications that lower the seizure threshold (e.g. certain antidepressants, antipsychotics, or tramadol), the combined effect should be considered.
Importantly, interference with laboratory tests has been reported. Serum creatinine levels may show transient variations after Gadovist administration. If kidney function tests are planned, they should ideally be performed before the contrast-enhanced MRI or at least 24 hours after the procedure to avoid potentially misleading results.
| Drug Category | Consideration | Clinical Action |
|---|---|---|
| Nephrotoxic drugs (e.g. NSAIDs, aminoglycosides, ciclosporin) | May impair renal elimination of gadobutrol | Assess kidney function before administration |
| Drugs lowering seizure threshold (e.g. tramadol, certain antidepressants) | Potential additive effect on seizure risk | Monitor patients with epilepsy closely |
| Metformin | Not a direct interaction, but renal function should be confirmed | Check kidney function; no need to discontinue metformin for MRI contrast (unlike iodinated contrast) |
| Beta-blockers | May reduce the effectiveness of adrenaline (epinephrine) in treating anaphylaxis | Have alternative anaphylaxis treatments available |
What Is the Correct Dosage of Gadovist?
Gadovist dosage depends on body weight and the type of MRI examination. The standard adult dose is 0.1 ml per kg body weight (equivalent to 0.1 mmol/kg). It is always administered by a healthcare professional as an intravenous injection.
Gadovist is never self-administered. A healthcare professional will inject it into a vein using a thin needle or an automated power injector. The contrast-enhanced MRI scan can begin immediately after injection. The lowest dose that provides sufficient diagnostic enhancement should always be used.
Adults
CNS Indications (Brain and Spine)
The recommended dose is 0.1 mmol/kg body weight (0.1 ml/kg of the 1.0 M solution). For a 70 kg adult, this corresponds to 7 ml. A minimum dose of 0.075 mmol/kg (0.075 ml/kg) may be used for CNS imaging. If clinical suspicion remains despite a normal MRI, or if more precise information could influence therapy, an additional injection of up to 0.2 ml/kg may be given within 30 minutes of the first injection, for a maximum total dose of 0.3 ml/kg (21 ml for a 70 kg person).
Whole-Body MRI (Excluding MRA)
A dose of 0.1 ml/kg body weight is generally sufficient to answer the clinical question.
Contrast-Enhanced MR Angiography (CE-MRA)
Single field of view: 7.5 ml for patients under 75 kg; 10 ml for patients 75 kg or over (equivalent to 0.1–0.15 mmol/kg).
More than one field of view: 15 ml for patients under 75 kg; 20 ml for patients 75 kg or over (equivalent to 0.2–0.3 mmol/kg).
Children (All Ages Including Neonates)
Paediatric Dosing
The recommended dose for children of all ages (including neonates) is 0.1 mmol/kg body weight (0.1 ml/kg) for all indications. In neonates up to 4 weeks and infants up to 1 year, only a single dose should be given per examination and repeat injections should not occur within 7 days, due to immature kidney function.
Elderly Patients
No dose adjustment is necessary for patients aged 65 years and older. However, a blood test to assess kidney function is recommended before administration, as renal clearance of gadobutrol may be reduced in the elderly population.
Patients with Kidney Impairment
Gadovist is not recommended for patients with severe kidney problems (GFR <30 ml/min/1.73m²) or those who have recently undergone or are about to undergo liver transplantation. If use is unavoidable, the dose must not exceed 0.1 mmol/kg body weight, only a single dose should be given, and at least 7 days must elapse before any repeat injection. Haemodialysis shortly after administration may help remove Gadovist from the body in patients already undergoing dialysis.
| Patient Group | Indication | Recommended Dose | Max. Dose |
|---|---|---|---|
| Adults | CNS (brain, spine) | 0.1 ml/kg (min 0.075 ml/kg) | 0.3 ml/kg |
| Adults | Whole-body MRI | 0.1 ml/kg | 0.1 ml/kg |
| Adults | CE-MRA (1 FOV) | 7.5–10 ml | 10 ml |
| Adults | CE-MRA (>1 FOV) | 15–20 ml | 20 ml |
| Children (all ages) | All indications | 0.1 ml/kg | 0.1 ml/kg |
| Severe renal impairment | If unavoidable | 0.1 ml/kg (single dose only) | 0.1 ml/kg; ≥7 days between doses |
Overdose
Overdose is unlikely in clinical practice because Gadovist is administered by trained healthcare professionals. In the rare event of an accidental overdose, the physician will treat any symptoms and may use haemodialysis to remove Gadovist from the body. After three dialysis sessions, approximately 98% of the substance is eliminated. However, there is no evidence that dialysis prevents nephrogenic systemic fibrosis (NSF) and it should not be used as a treatment for NSF. Cardiovascular monitoring (ECG) and kidney function assessment are recommended as safety measures after overdose.
What Are the Side Effects of Gadovist?
Like all medicines, Gadovist can cause side effects, although not everyone experiences them. The most common side effects are headache, nausea, and dizziness. Serious allergic reactions are rare but possible. Patients are monitored for at least 30 minutes after injection.
The majority of adverse reactions occur within 30 minutes of Gadovist administration. However, delayed reactions (hours to several days after injection) have been observed in rare cases. If you experience any unusual symptoms after receiving Gadovist, contact your doctor or radiologist immediately.
The most serious reactions reported with Gadovist (some of which have been fatal or life-threatening) include: cardiac arrest, acute respiratory distress syndrome (ARDS), pulmonary oedema, and severe anaphylactic reactions (including respiratory arrest and shock). If you experience facial or throat swelling, difficulty breathing, severe dizziness, or loss of consciousness, emergency medical treatment is required immediately.
Common
May affect up to 1 in 10 people
- Headache
- Nausea
Uncommon
May affect up to 1 in 100 people
- Dizziness
- Altered taste (dysgeusia)
- Numbness and tingling (paraesthesia)
- Low blood pressure (hypotension)
- Hives (urticaria)
- Facial swelling
- Eyelid swelling (periorbital oedema)
- Flushing
- Vomiting
- Skin redness (erythema)
- Itching (pruritus)
- Rash
- Injection site reactions (warmth, coolness, pain, swelling, redness)
- Hot flushes
Rare
May affect up to 1 in 1,000 people
- Fainting (syncope)
- Seizures (convulsions)
- Altered sense of smell (parosmia)
- Rapid heart rate (tachycardia)
- Palpitations
- Dry mouth
- General malaise
- Feeling cold
Not Known (Post-Marketing Reports)
Frequency cannot be estimated from available data
- Severe anaphylactic/anaphylactoid reactions (shock)
- Cardiac arrest
- Acute respiratory distress syndrome (ARDS)
- Pulmonary oedema
- Respiratory arrest
- Bronchospasm
- Cyanosis (blue discolouration of lips)
- Laryngeal/pharyngeal oedema (throat swelling)
- Angioedema (facial, throat, mouth, lip swelling)
- Increased or decreased blood pressure
- Chest pain
- Conjunctivitis (eye inflammation)
- Increased sweating
- Cough, sneezing
- Burning sensation, pallor
- Dyspnoea (shortness of breath)
- Nephrogenic systemic fibrosis (NSF) – skin thickening that may affect soft tissues and internal organs
- Transient changes in serum creatinine levels
If you experience any of the following after receiving Gadovist, tell the MRI department staff immediately as these may be early signs of a serious reaction: swelling of the face, lips, tongue, or throat; coughing or sneezing; difficulty breathing; itching; runny nose; or hives. Your examination may need to be stopped and you may require additional treatment.
Patients with a history of allergies (hay fever, asthma, eczema) or previous reactions to contrast media are at increased risk of hypersensitivity reactions. Patients with cardiovascular disease may be more susceptible to severe or life-threatening allergic reactions. Healthcare facilities where Gadovist is administered must have medications and equipment for treating anaphylaxis readily available.
How Should Gadovist Be Stored?
Gadovist should be stored out of the sight and reach of children. No special storage conditions are required. It should not be used after the expiry date or if the solution appears discoloured, contains particles, or the container is damaged.
Gadovist is a clear, colourless to slightly yellowish solution for injection. Before use, the solution should be visually inspected. It must not be used if there is marked discolouration, if particles are visible, or if the packaging appears to be defective.
Chemical and physical in-use stability has been demonstrated for 24 hours at 20–25°C. From a microbiological standpoint, if the product is not used immediately after opening, in-use storage times and conditions are the responsibility of the user and should not exceed 24 hours at 20–25°C.
For single-dose use (2 ml, 7.5 ml, and 15 ml vials), any unused solution must be discarded after each examination. For multi-dose use (30 ml and 65 ml vials), any remaining solution that is not used within a continuous 24-hour period after first opening must be discarded. Multi-dose vials must be administered using an approved power injector system, and all single-use components must be replaced between patients.
Gadovist should not be disposed of via household waste or wastewater. Healthcare staff will dispose of the product in accordance with local regulations for pharmaceutical waste to protect the environment.
What Does Gadovist Contain?
The active substance in Gadovist is gadobutrol. Each millilitre of solution contains 604.72 mg of gadobutrol, corresponding to 1.0 mmol gadobutrol (containing 157.25 mg gadolinium).
Gadovist is formulated as a ready-to-use solution for injection. In addition to the active ingredient gadobutrol, the formulation contains the following inactive (excipient) ingredients:
- Calcobutrol sodium: A stabilising agent that helps maintain the chemical integrity of the chelate complex
- Trometamol (tromethamine): A buffer that maintains the pH of the solution within the appropriate range
- Hydrochloric acid 1 N: Used for pH adjustment
- Water for injections: The solvent base
Gadovist is available in several vial sizes to accommodate different clinical needs:
- 1 or 3 vials of 2 ml solution
- 1 or 10 vials of 7.5 ml, 15 ml, or 30 ml solution
- 1 or 10 vials of 65 ml solution (in 100 ml bottles)
Not all pack sizes may be marketed in every country. Gadovist is manufactured by Bayer AG, Berlin, Germany, and is approved throughout the European Economic Area under various trade names, with the most common being Gadovist. In some markets, the same formulation may be available under the brand name Pixxoscan.
Frequently Asked Questions About Gadovist
Gadovist (gadobutrol) belongs to the macrocyclic class of gadolinium-based contrast agents (GBCAs). The key distinction from linear GBCAs is molecular stability: macrocyclic agents hold the gadolinium ion within a rigid, cage-like structure, making them significantly more resistant to releasing free gadolinium into the body. Furthermore, Gadovist has the highest available concentration (1.0 mmol/ml) among all approved GBCAs, which allows for smaller injection volumes. It also has high relaxivity, meaning it provides strong signal enhancement per unit of gadolinium. Regulatory agencies including the EMA have recommended restricting the use of linear GBCAs while maintaining the availability of macrocyclic agents like Gadovist due to their superior safety profile regarding gadolinium retention.
With normal kidney function, more than 99% of gadobutrol is excreted in the urine within 24 hours of injection. The elimination half-life is approximately 1.8 hours. Research has shown that trace amounts of gadolinium may be retained in certain body tissues (including the brain) following GBCA administration. However, studies indicate that macrocyclic agents like gadobutrol result in significantly lower levels of retained gadolinium compared to linear agents. To date, no adverse clinical effects have been associated with the small amounts of gadolinium retained after macrocyclic GBCA administration in patients with normal kidney function.
Yes, although allergic and allergic-like (anaphylactoid) reactions to Gadovist are uncommon. Mild reactions such as hives, itching, or nausea occur in a small percentage of patients. Severe anaphylactic reactions (difficulty breathing, throat swelling, cardiovascular collapse) are rare. The risk is higher in patients with a history of allergies, asthma, or previous reactions to contrast agents. This is why all patients are observed for at least 30 minutes after injection, and emergency treatment equipment is always available at the MRI facility.
Gadovist is approved for use in children of all ages, including neonates (newborns). The recommended paediatric dose is 0.1 mmol/kg body weight for all indications. Special care is taken with neonates (up to 4 weeks) and infants (up to 1 year) because their kidneys are not fully mature. In these youngest patients, only a single dose is given per examination, and repeat injections must be separated by at least 7 days. Clinical studies and post-marketing surveillance have confirmed the safety and efficacy of Gadovist in the paediatric population.
If you experience any symptoms during or shortly after the MRI – such as itching, hives, swelling, difficulty breathing, dizziness, nausea, or chest tightness – inform the MRI staff immediately. They are trained to recognise and treat adverse reactions. If symptoms develop after you have left the facility (delayed reactions can occur hours to days later), contact your doctor or seek medical attention promptly. Most reactions are mild and resolve quickly, but any new symptoms after contrast administration should be medically evaluated.
Gadovist is eliminated entirely through the kidneys. It is not metabolised in the body but is filtered by the kidneys and excreted unchanged in the urine. In patients with normal kidney function, the elimination half-life is approximately 1.8 hours, and more than 99% of the injected dose is recovered in urine within 24 hours. In patients with impaired kidney function, elimination takes longer, which is why kidney assessment before administration is so important. Drinking plenty of water after the procedure can help support normal kidney function.
References
- European Medicines Agency (EMA). Gadovist – Summary of Product Characteristics. Available at: www.ema.europa.eu. Accessed December 2025.
- American College of Radiology (ACR). ACR Manual on Contrast Media, Version 2024. ACR Committee on Drugs and Contrast Media.
- European Society of Urogenital Radiology (ESUR). ESUR Guidelines on Contrast Agents, Version 10.0, 2018. European Radiology.
- Kanda T, Ishii K, Kawaguchi H, et al. High signal intensity in the dentate nucleus and globus pallidus on unenhanced T1-weighted MR images: relationship with increasing cumulative dose of a gadolinium-based contrast material. Radiology. 2014;270(3):834–841.
- Radbruch A, Weberling LD, Kieslich PJ, et al. Gadolinium retention in the dentate nucleus and globus pallidus is dependent on the class of contrast agent. Radiology. 2015;275(3):783–791.
- Thomsen HS, Morcos SK, Almén T, et al. Nephrogenic systemic fibrosis and gadolinium-based contrast media: updated ESUR Contrast Medium Safety Committee guidelines. European Radiology. 2013;23(2):307–318.
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List, 2023. Geneva: World Health Organization.
- Endrikat J, Vogtlaender K, Gerlach M, et al. Safety of gadobutrol: results from 42 clinical phase II to IV studies and postmarketing surveillance. Investigative Radiology. 2016;51(9):537–543.
- Rohrer M, Bauer H, Mintorovitch J, et al. Comparison of magnetic properties of MRI contrast media solutions at different magnetic field strengths. Investigative Radiology. 2005;40(11):715–724.
- U.S. Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA evaluating the risk of brain deposits with repeated use of gadolinium-based contrast agents for MRIs. 2017.
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