Version July 2025
Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadodiamide is not approved for intrathecal use.
Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of gadodiamide in these patients unless the diagnostic information is essential and not available with non–contrast-enhanced magnetic resonance imaging (MRI) or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs.
Do not administer gadodiamide to patients with chronic, severe kidney disease (GFR <30 mL/minute/1.73 m2) 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, >60 years, hypertension, diabetes), estimate the GFR through laboratory testing. Do not exceed the recommended gadodiamide dose and allow a sufficient period of time for elimination of the drug from the body prior to any readministration.
Note: Dosing for patients >130 kg (286 pounds) has not been studied.
Body imaging: IV:
Kidney: 0.05 mmol/kg (0.1 mL/kg).
Intrathoracic (noncardiac), intra-abdominal, pelvic cavities: 0.1 mmol/kg (0.2 mL/kg).
CNS imaging: IV: 0.1 mmol/kg (0.2 mL/kg); a repeat dose of 0.2 mmol/kg (0.4 mL/kg) given 20 minutes after the initial dose has been studied in a clinical trial with some diagnostic benefit.
Magnetic resonance angiography (MRA) (unlabeled use in US): IV: 0.1 mmol/kg (0.2 mL/kg) (Ref).
Musculoskeletal imaging (off-label): IV: 0.3 mmol/kg (0.6 mL/kg) (Ref).
GFR ≥30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution. Risk for NSF development increases as renal function decreases.
GFR <30 mL/minute/1.73 m2: Use is contraindicated
Hemodialysis: If administered to patients already receiving hemodialysis, consider prompt hemodialysis following exposure (eg, within 3 hours) (Ref). Data has shown hemodialysis enhances gadolinium elimination with average gadolinium excretory rates of 78%, 96%, and 99% in the first to third hemodialysis sessions, respectively (Ref).
Peritoneal dialysis: Likely to be less efficient at clearing gadolinium (Ref).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing; use with caution.
Note: Dosing for patients >130 kg (286 pounds) has not been studied.
Body imaging: Children ≥2 years and Adolescents: IV: Refer to adult dosing.
CNS imaging: Children ≥2 years and Adolescents ≤16 years: IV: 0.1 mmol/kg (0.2 mL/kg).
Musculoskeletal imaging (off-label): Adolescents ≥13 years: IV: Refer to adult dosing.
Children ≥2 years and Adolescents:
GFR ≥30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution. Risk for nephrogenic systemic fibrosis (NSF) development increases as renal function decreases.
GFR <30 mL/minute/1.73 m2: Use is contraindicated
Dialysis: There are no pediatric specific recommendations; based on experience in adult patients the following has been observed:
Hemodialysis: If administered to patients already receiving hemodialysis, consider prompt hemodialysis following exposure (eg, within 3 hours) (Ref). Data has shown hemodialysis enhances gadolinium elimination with average gadolinium excretory rates of 78%, 96%, and 99% in the first to third hemodialysis sessions, respectively (Ref).
Peritoneal dialysis: Likely to be less efficient at clearing gadolinium (Ref).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported incidences for adverse reactions are for adults.
1% to 10%:
Cardiovascular: Cardiac arrhythmia (≤1%), chest pain (≤1%), deep vein thrombophlebitis (≤1%), flushing (≤1%), heart failure (≤1%), syncope (≤1%), vasodilation (≤1%)
Dermatologic: Diaphoresis (≤1%), erythematous rash (≤1%), pruritus (≤1%), skin rash (≤1%), urticaria (≤1%)
Endocrine & metabolic: Hot flash (≤1%)
Gastrointestinal: Abdominal pain (≤1%), ageusia (≤1%), diarrhea (≤1%), dysgeusia (≤1%), eructation (≤1%), melena (≤1%), nausea (≤3%), vomiting (≤1%), xerostomia (≤1%)
Hepatic: Abnormal liver function (≤1%)
Hypersensitivity: Nonimmune anaphylaxis (≤1%)
Local: Injection-site reaction (≤1%)
Nervous system: Ataxia (≤1%), dizziness (≤3%), exacerbation of migraine headache (≤1%), fatigue (≤1%), headache (≤3%), malaise (≤1%), pain (≤1%), paresthesia (≤1%), rigors (≤1%), seizure (≤1%; including tonic-clonic seizure), tremor (≤1%)
Neuromuscular & skeletal: Acute exacerbations of multiple sclerosis (≤1%), arthralgia (≤1%), myalgia (≤1%)
Ophthalmic: Visual disturbance (≤1%)
Otic: Tinnitus (≤1%)
Renal: Acute kidney injury (≤1%)
Respiratory: Dyspnea (≤1%), rhinitis (≤1%)
Miscellaneous: Fever (≤1%)
Frequency not defined:
Hypersensitivity: Anaphylaxis
Miscellaneous: Laboratory test abnormality (change in serum iron level)
Postmarketing:
Dermatologic: Skin changes (plaques) (Ramalho 2017)
Gastrointestinal: Acute pancreatitis
Renal: Nephrogenic systemic fibrosis
Respiratory: Acute respiratory distress syndrome, pulmonary edema
Hypersensitivity to gadodiamide or any component of the formulation; chronic severe kidney disease (GFR <30 mL/minute/1.73 m2); acute kidney injury.
Canadian labeling: Additional contraindications (not in US labeling): Neonates up to 4 weeks of age (due to their immature renal function).
Concerns related to adverse effects:
• Gadolinium retention: Gadolinium is retained for months or years in brain, bone, skin, and other organs (kidney, liver, spleen); the highest concentration and longest duration have been found in the bone. Linear gadolinium-based contrast agents (GBCAs) (gadodiamide and gadoversetamide > gadoxetate disodium, gadopentetate dimeglumine, and gadobenate dimeglumine) result in more retention than macrocyclic GBCAs (gadoterate meglumine, gadobutrol, and gadoteridol). Pathologic and clinical consequences of gadolinium retention in skin and other organs have been established in patients with impaired renal function; there also have been rare reports of pathologic skin changes in patients with normal renal function. Consequences of gadolinium retention in the brain or in patients with normal renal function have not been established. Patients with normal renal function that may be at higher risk for gadolinium retention include: patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions; take GBCA retention characteristics into consideration for these patients. Minimize repetitive GBCA imaging studies.
• Hypersensitivity reactions: Hypersensitivity, including anaphylactic reactions (rare), may occur; appropriate equipment (eg, ventilator) and emergency medications (eg, epinephrine) should be available during use. Delayed reactions may also occur (within several hours of administration). Patients with a history of allergic reactions and/or bronchial asthma may be at an increased risk for developing hypersensitivity reactions; use caution in these patients.
• Nephrogenic systemic fibrosis: The risk for nephrogenic systemic fibrosis (NSF) appears lower in patients with moderate, chronic renal disease (GFR 30 to 59 mL/minute/1.73 m2) and little, if any, in patients with mild, chronic renal disease (GFR 60 to 89 mL/minute/1.73 m2). NSF, a potentially fatal disease, affects the skin, muscle, and internal organs. All patients should be screened for renal dysfunction prior to administration; estimate GFR in patients at risk for chronic renal disease (diabetes, chronic hypertension, >60 years of age). In patients at risk of NSF, do not exceed the recommended dosage and allow sufficient time (ie, several half-lives) for elimination prior to readministration (avoidance of readministration is preferred). In patients receiving hemodialysis, consider prompt initiation of hemodialysis following administration.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment; contraindicated in patients with acute kidney injury or chronic, severe renal impairment (GFR <30 mL/minute/1.73 m2). Dose-dependent worsening of renal function or acute renal failure has occurred in patients with renal insufficiency, generally within 48 hours following administration. Evaluate renal function in patients with renal impairment prior to use; consider follow-up monitoring.
Other warnings/precautions:
• Repeat dosing: Safety of repeat dosing has only been studied in adults for CNS studies.
• Scan interpretation: Use caution when interpreting a contrast-enhanced scan in the absence of a companion unenhanced noncontrast MRI.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Injectable, Injection:
Omniscan: 287 mg/mL (10 mL [DSC], 15 mL [DSC], 20 mL [DSC])
Solution, Intravenous:
Omniscan: 287 mg/mL (5 mL [DSC], 10 mL, 15 mL, 20 mL, 100 mL [DSC])
No
Solution (Omniscan Intravenous)
287 mg/mL (per mL): $6.67
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Omniscan: 287 mg/mL (5 mL, 10 mL, 15 mL, 20 mL)
IV: For IV use only; not for intrathecal use. Administer as bolus injection. Flush line with NS 5 mL to ensure complete injection of medium. Imaging should be completed within 60 minutes of injection. Following administration in musculoskeletal imaging (off-label use), injection site was flushed with 40 mL NS (Ref).
IV: For IV use only; not for intrathecal use. Administer as bolus injection. Flush line with 5 mL NS to ensure complete injection of medium. Imaging should be completed within 60 minutes of injection. Following administration in musculoskeletal imaging, injection site was flushed with 40 mL NS (Ref).
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication;
Omniscan: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020123s052,022066s015lbl.pdf#page=23
Body imaging: Contrast medium for magnetic resonance imaging (MRI) to visualize lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and retroperitoneal space
CNS imaging: Contrast medium for magnetic resonance imaging (MRI) to visualize lesions with abnormal vascularity in the brain, spine, and associated tissues
Canadian labeling: Additional indications (not in US labeling): Contrast medium for MRI to visualize breast or musculoskeletal lesions with abnormal vascularity and for magnetic resonance angiography (MRA) to visualize and detect stenosis of the renal and aortoiliac arteries
Magnetic resonance angiography (MRA); Musculoskeletal imaging
None known.
There are no known significant interactions.
Evaluate pregnancy status prior to the use of gadolinium-based contrast agents in patients who may become pregnant (ACR 2023).
Gadolinium-based contrast agents may cross the placenta (ACOG 2017; ACR 2023).
Outcome data following maternal use of gadolinium-based contrast agents during pregnancy are limited (ACR 2023)
Pregnant patients may be at increased risk for gadolinium retention. Use of gadolinium-based contrast agents in pregnancy is controversial and should be limited. A gadolinium-based contrast agent with MRI may be considered for use in pregnancy if it will significantly improve diagnostic performance and is expected to improve fetal or maternal outcome (ACOG 2017). In addition, use should only be considered if information needed from the MRI study cannot be acquired without using a contrast agent and cannot be deferred until after delivery. Agents with a low risk for development of nephrogenic systemic fibrosis should be used at the lowest effective dose (ACR 2023).
Gadolinium-based contrast agents may be present in breast milk (ACOG 2017; ACR 2023).
According to the manufacturer, the decision to breastfeed should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Because of the low expected excretion into breast milk and the low absorption from an infant's GI tract, breastfeeding may be continued without interruption after use (ACOG 2017; ACR 2023). Theoretically, the taste of milk could be altered if it contains contrast media. Patients who prefer to temporarily withhold breastfeeding may express and discard milk from both breasts during a period of 12 to 24 hours after the administration of contrast media. They can pump and store milk prior to the procedure then bottle feed using the stored milk during this time (ACR 2023).
Signs of hypersensitivity (during and for several hours after procedure); renal function (prior to administration); short- and long-term monitoring of signs and symptoms of NSF (eg, burning, itching, swelling, hardening and/or tightening of skin, joint stiffness, deep hip or rib bone pain, muscle weakness, limited range of motion, and/or yellowed/raised spots on whites of eye). Evaluate pregnancy status prior to use in patients who may become pregnant (ACR 2023).
Gadodiamide is a gadolinium-containing paramagnetic agent. Exposure to an external magnetic field induces a large local magnetic field in exposed tissues. This local magnetism disrupts water protons in the vicinity, resulting in a change in proton density and spin characteristics, which can be detected by the imaging device.
Distribution: Vd: 200 ± 61 mL/kg; does not cross intact blood-brain barrier; distribution half-life: 3.7 ± 2.7 minutes
Half-life elimination: 77.8 ± 16 minutes
Excretion: Urine (~95% within 24 hours)
