Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Gadobutrol
Drug ID BADD_D00984
Description Intravenous gadobutrol is a second-generation extracellular non-ionic macrocyclic GBCA (gadolinium-based contrast agent) used in magnetic resonance imaging (MRI) in adults and children older than 2 years of age. It may help visualize and detect vascular abnormalities in the blood brain barrier (BBB) and central nervous system (CNS). In patients with impaired renal function, gadolinium based contrast agents increase the risk of nephrogenic systemic fibrosis (NSF). A physician should be contacted if symptoms of NSF are encountered, such as dark or red patches on the skin; stiffness in joints; trouble moving, bending or straightening arms, hands, legs or feet; burning, itching, swelling, scaling, hardening and tightening of skin; pain in hip bones or ribs; or muscle weakness. Common adverse reactions that may be experienced include headache, nausea, feeling hot, abnormal taste, and warmth, burning or pain local to the injection site. General precautions should be taken in patients who are pregnant or breastfeeding, or who have a history of allergic reaction to contrast media, bronchial asthma or an allergic respiratory disorder.
Indications and Usage For diagnostic use only. Indicated for adults and children age 2 and over for contrast enhancement during cranial and spinal MRI, and for contrast-enhanced magnetic resonance angiography (CE-MRA). Gadobutrol is particularly suited for the detection of very small lesions and for the visualization of tumors that do not readily take up contrast media. It may be a desired agent when the exclusion or demonstration of an additional pathology may influence the choice of therapy or patient management. It may also be suitable for perfusion studies in the diagnosis of stroke, detection of focal cerebral ischemia, and in studies of tumor perfusion.
Marketing Status approved
ATC Code V08CA09
DrugBank ID DB06703
KEGG ID D07420
MeSH ID C090600
PubChem ID 189914
TTD Drug ID D0P1IZ
NDC Product Code 50419-325; 57884-0035; 70436-122; 65219-281
UNII 1BJ477IO2L
Synonyms gadobutrol | Gadovist | gadolinium-DO3A-butriol | Gd-DO3A-butriol
Chemical Information
Molecular Formula C18H34N4O9
CAS Registry Number 770691-21-9
SMILES C1CN(CCN(CCN(CCN1CC(=O)O)CC(=O)O)C(CO)C(CO)O)CC(=O)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Nasal discomfort22.12.03.0120.019206%Not Available
Oral pruritus07.05.05.0020.088206%Not Available
Musculoskeletal discomfort15.03.04.0010.027742%Not Available
Infusion site pain12.07.05.002; 08.02.05.014--Not Available
Mitochondrial toxicity14.11.02.001; 12.03.01.0090.021340%Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.034856%Not Available
Pharyngeal erythema22.04.05.010--Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.093897%Not Available
Paraesthesia oral07.05.05.035; 17.02.06.0080.071134%Not Available
Pulseless electrical activity02.03.04.0200.007113%Not Available
Hot flush08.01.03.027; 24.03.01.005; 21.02.02.0010.071134%
Eye movement disorder17.02.05.025; 06.05.02.0080.017783%Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.015649%Not Available
Sensation of foreign body08.01.09.0020.085361%Not Available
Sensorimotor disorder17.05.03.0090.007113%Not Available
Urine analysis abnormal13.13.02.008--Not Available
Unevaluable event08.01.03.0510.071845%Not Available
Anaphylactoid shock24.06.02.005; 10.01.07.004--Not Available
Infusion site extravasation08.02.05.007; 12.07.05.0080.019206%
Cardiovascular insufficiency02.11.01.011; 24.06.03.0050.007113%Not Available
Immediate post-injection reaction10.01.03.032; 08.06.01.019--Not Available
Pharyngeal disorder22.04.05.0070.027742%Not Available
Nephrogenic systemic fibrosis23.03.02.012; 15.06.01.009; 20.01.01.004; 10.04.02.0070.007113%Not Available
Adverse reaction08.06.01.0180.039835%Not Available
Oropharyngeal discomfort07.05.05.008; 22.12.03.0150.119505%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004--
Mouth swelling23.04.01.020; 10.01.05.020; 07.05.04.007--Not Available
Nasal pruritus22.04.03.0180.039835%Not Available
Consciousness fluctuating17.02.04.0190.007113%Not Available
Pharyngeal hypoaesthesia22.04.05.017; 17.02.06.0340.015649%Not Available
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