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MedsAcross

Molecule

Gadodiamide

Paramagnetic Contrast Agent
Available on request
Presentations
3
Brands
1
Manufacturers
1
Available from stock
0

Gadodiamide is a paramagnetic contrast agent indicated for intravenous use to visualize lesions with abnormal vascularity in the brain, spine, and associated tissues, among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Gadodiamide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Paramagnetic Contrast Agent, Magnetic Resonance Contrast Activity
US FDA first approval
8 January 1993
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous
Dosage forms
Injection
Identifiers
UNII 84F6U3J2R6CAS 131410-48-5DrugBank DB00225Q72479907

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues. Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space

Source: US FDA prescribing information

Dosing overview

CNS – Adults and Pediatrics, 2 to 16 years of age: 0.2 mL/kg (0.1 mmol/kg). Body – Adults and Pediatrics, 2 to 16 years of age: Kidney: 0.1 mL/kg (0.05 mmol/kg) Intrathoracic, intra-abdominal, and pelvic cavities: 0.2 mL/kg (0.1 mmol/kg)

Source: US FDA prescribing information

Contraindications

OMNISCAN is contraindicated in patients with: Chronic, severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m 2 ) or acute kidney injury Prior hypersensitivity to OMNISCAN Patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ) or acute kidney injury.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning: Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. OMNISCAN is not approved for intrathecal use. GBCAs increase the risk for nephrogenic systemic fibrosis among patients with impaired elimination of the drugs. Hypersensitivity Reactions: Anaphylactoid and other serious hypersensitivity reactions including fatal reactions have occurred particularly in patients with history of allergy or drug reactions. Monitor patients closely for need of emergency cardiorespiratory support. Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs. Acute Renal Failure: Acute renal failure has occurred in patients with preexisting renal insufficiency. Use the lowest necessary dose of OMNISCAN and evaluate renal function in these patients.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are discussed in greater detail in other sections of the label: Nephrogenic systemic fibrosis Hypersensitivity reactions Acute Renal Failure The most frequent adverse reactions (≤ 3%) observed during OMNISCAN adult clinical studies were nausea, headache, and dizziness. Serious or life-threatening reactions include: cardiac failure, arrhythmia and myocardial infarction

Source: US FDA prescribing information

Storage

Store OMNISCAN at controlled room temperature 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

3 presentations of Gadodiamide, sorted by availability.

MedicineManufacturerRegisterAvailability
Omniscan 2870 mg/10 mL injectionIntravenousGE HealthcareUS FDAAvailable on request
Omniscan 4305 mg/15 mL injectionIntravenousGE HealthcareUS FDAAvailable on request
Omniscan 5740 mg/20 mL injectionIntravenousGE HealthcareUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 8 January 1993Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Gadodiamide available for export from India?

Yes, on request. MedsAcross lists 3 presentations of Gadodiamide and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Gadodiamide have?

The catalogue lists 1 brand names for Gadodiamide, including Omniscan.

Is Gadodiamide approved by the US FDA?

Yes. The US FDA first approved Gadodiamide on 8 January 1993, according to Drugs@FDA.

Does Gadodiamide need cold chain shipping?

No listed presentation of Gadodiamide is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. OMNISCAN prescribing information (GE Healthcare). U.S. National Library of Medicine, DailyMed. Retrieved 18 April 2025

Request Gadodiamide for export supply

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