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  1. Postmarket Drug Safety Information for Patients and Providers

Information on Gadolinium-Based Contrast Agents

Gadolinium-Based Contrast Agents (GBCA) are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA).

Magnetic Resonance Imaging (MRI) is a medical imaging procedure for making images of the internal structures of the body. MRI scanners use strong magnetic fields and radio waves (radiofrequency energy) to make images. The signal in an MR image comes mainly from the protons in fat and water molecules in the body.

During an MRI exam, an electric current is passed through coiled wires to create a temporary magnetic field in a patient’s body. Radio waves are sent from and received by a transmitter/receiver in the machine, and these signals are used to make digital images of the scanned area of the body. A typical MRI scan last from 20 - 90 minutes, depending on the part of the body being imaged.

For some MRI exams, intravenous (IV) drugs, such as gadolinium-based contrast agents (GBCAs) are used to change the contrast of the MR image. Gadolinium-based contrast agents are rare earth metals that are usually given through an IV in the arm.

For more information about MRI and their safety and risks, please see the Center for Radiological Health’s consumer information page.

To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program listed below.

Contact FDA
1-800-FDA-0178 Fax

Report a Serious Problem
MedWatch Online
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20857

Related Information

Regulatory History and Labeling from Drugs@FDA

Gadolinium-Based Contrast Agents:

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