gadoterate meglumine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
diagnostic agents, gadolinium derivatives	1267	92943-93-6

Description:

Molecule

Description

Synonyms:

dotarem
gadoterate meglumine
magnescope
Gd-DOTA meglumine

Molecular weight: 753.86
Formula: C23H42GdN5O13
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
March 20, 2013	FDA	GUERBET

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Urticaria	533.15	48.42	237	3668	117655	46564502
Pruritus	247.88	48.42	185	3720	242167	46439990
Erythema	243.96	48.42	150	3755	142670	46539487
Sneezing	167.31	48.42	56	3849	12685	46669472
Dyspnoea	153.21	48.42	200	3705	515348	46166809
Throat irritation	142.03	48.42	62	3843	28839	46653318
Product use in unapproved indication	141.46	48.42	90	3815	90183	46591974
Cough	102.00	48.42	110	3795	230139	46452018
Vomiting	101.65	48.42	154	3751	452640	46229517
Contrast media reaction	95.08	48.42	21	3884	984	46681173
Nausea	75.68	48.42	172	3733	687282	45994875
Feeling hot	72.46	48.42	43	3862	37885	46644272
Type I hypersensitivity	68.13	48.42	19	3886	2327	46679830
Throat tightness	63.28	48.42	32	3873	20607	46661550
Laryngeal discomfort	56.14	48.42	11	3894	284	46681873
Chest discomfort	54.22	48.42	51	3854	90218	46591939
Laryngeal oedema	49.09	48.42	18	3887	5301	46676856
Rash	49.02	48.42	98	3807	356414	46325743

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Urticaria	344.88	52.11	120	1336	54486	29896536
Pruritus	141.06	52.11	81	1375	118123	29832899
Erythema	133.98	52.11	68	1388	77383	29873639
Nausea	96.87	52.11	93	1363	296864	29654158
Vomiting	91.37	52.11	79	1377	219739	29731283
Nephrogenic systemic fibrosis	66.71	52.11	19	1437	4352	29946670
Throat irritation	65.90	52.11	22	1434	8526	29942496

Pharmacologic Action:

Source	Code	Description
MeSH PA	D003287	Contrast Media
MeSH PA	D064907	Diagnostic Uses of Chemicals

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Magnetic resonance imaging	indication	113091000

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

ID	Source
4032690	VUID
N0000188988	NUI
4032690	VANDF
C0114857	UMLSCUI
CHEBI:73727	CHEBI
CHEMBL2219415	ChEMBL_ID
C072417	MESH_SUPPLEMENTAL_RECORD_UI
6918037	PUBCHEM_CID
L0ND3981AG	UNII
1421151	RXNORM
29771	MMSL
92135	MMSL
d06307	MMSL
006172	NDDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
CLARISCAN	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2943	INJECTION, SOLUTION	376.90 mg	INTRAVENOUS	ANDA	33 sections
CLARISCAN	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2943	INJECTION, SOLUTION	376.90 mg	INTRAVENOUS	ANDA	33 sections
DOTAREM	HUMAN PRESCRIPTION DRUG LABEL	1	67684-2000	Injection	376.90 mg	Intravenous	NDA	29 sections
DOTAREM	HUMAN PRESCRIPTION DRUG LABEL	1	67684-2000	Injection	376.90 mg	Intravenous	NDA	29 sections
DOTAREM	HUMAN PRESCRIPTION DRUG LABEL	1	67684-2001	Injection	376.90 mg	Intravenous	NDA	29 sections
DOTAREM	HUMAN PRESCRIPTION DRUG LABEL	1	67684-2001	Injection	376.90 mg	Intravenous	NDA	29 sections
DOTAREM	HUMAN PRESCRIPTION DRUG LABEL	1	67684-3001	Injection	376.90 mg	Intravenous	NDA	29 sections