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 Prescription
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
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Anaphylactic shock10.01.07.002; 24.06.02.004--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Angioedema23.04.01.001; 10.01.05.009--Not Available
Apathy19.04.04.002--Not Available
Aphasia19.21.01.001; 17.02.03.001--
Application site pain12.07.01.004; 08.02.01.004--Not Available
Blood pressure increased13.14.03.005--Not Available
Body temperature increased13.15.01.001--Not Available
Breast feeding26.05.01.001--Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
Burning sensation08.01.09.029; 17.02.06.001--Not Available
Cardiac arrest02.03.04.001--
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Circulatory collapse24.06.02.001--Not Available
Conjunctivitis11.01.06.012; 06.04.01.002--
Cough22.02.03.001--
Cyanosis24.03.01.007; 22.02.02.007; 02.01.02.002--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dry mouth07.06.01.002--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspnoea22.02.01.004; 02.01.03.002--
Erythema23.03.06.001--Not Available
Eyelid oedema23.04.01.003; 10.01.05.001; 06.04.04.004--Not Available
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.003--
Feeling cold08.01.09.008--Not Available
Feeling hot08.01.09.009--Not Available
Flat affect19.04.01.004--Not Available
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