gadoterate meglumine 🐶 Veterinary Use | 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

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	693.20	45.34	313	4858	165489	63318362
Erythema	318.64	45.34	190	4981	175561	63308290
Pruritus	278.32	45.34	231	4940	361222	63122629
Sneezing	213.38	45.34	73	5098	18145	63465706
Throat irritation	194.45	45.34	83	5088	37564	63446287
Dyspnoea	189.86	45.34	249	4922	661064	62822787
Product use in unapproved indication	135.95	45.34	114	5057	178966	63304885
Cough	134.78	45.34	141	5030	292602	63191249
Vomiting	121.66	45.34	185	4986	559432	62924419
Contrast media reaction	115.37	45.34	25	5146	1100	63482751
Throat tightness	99.83	45.34	46	5125	24841	63459010
Nausea	96.89	45.34	213	4958	854258	62629593
Gadolinium deposition disease	83.03	45.34	13	5158	86	63483765
Chest discomfort	79.14	45.34	68	5103	109901	63373950
Feeling hot	76.84	45.34	49	5122	50305	63433546
Type I hypersensitivity	68.77	45.34	20	5151	2922	63480929
Eye swelling	68.15	45.34	35	5136	23883	63459968
Laryngeal discomfort	55.36	45.34	11	5160	314	63483537
Rash	53.41	45.34	131	5040	560740	62923111
Laryngeal oedema	51.96	45.34	19	5152	5699	63478152
Paraesthesia	47.33	45.34	61	5110	156905	63326946
Burning sensation	46.06	45.34	37	5134	54370	63429481

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	442.19	43.52	155	1805	62222	34892749
Erythema	154.26	43.52	82	1878	88698	34866273
Pruritus	153	43.52	96	1864	141885	34813086
Vomiting	121.42	43.52	104	1856	247517	34707454
Nausea	111.33	43.52	114	1846	339794	34615177
Throat irritation	80.70	43.52	28	1932	10557	34944414
Nephrogenic systemic fibrosis	70.11	43.52	20	1940	3985	34950986
Contrast media deposition	61.90	43.52	9	1951	52	34954919
Dyspnoea	61.32	43.52	89	1871	376693	34578278
Sneezing	56.44	43.52	18	1942	5224	34949747

FDA Adverse Event Reporting System (Geriatric)

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	1036.21	44.44	438	6525	184763	79552662
Erythema	447.76	44.44	264	6699	223026	79514399
Pruritus	424.50	44.44	316	6647	394332	79343093
Sneezing	268.53	44.44	90	6873	19593	79717832
Throat irritation	264.44	44.44	108	6855	40838	79696587
Dyspnoea	222.74	44.44	319	6644	856706	78880719
Vomiting	210.75	44.44	273	6690	665555	79071870
Nausea	179.67	44.44	307	6656	956889	78780536
Cough	171.40	44.44	184	6779	366605	79370820
Product use in unapproved indication	158.07	44.44	148	6815	250211	79487214
Contrast media reaction	139.10	44.44	33	6930	2037	79735388
Gadolinium deposition disease	115.09	44.44	18	6945	109	79737316
Throat tightness	106.71	44.44	51	6912	27856	79709569
Feeling hot	94.45	44.44	61	6902	59673	79677752
Eye swelling	91.05	44.44	45	6918	26423	79711002
Chest discomfort	89.56	44.44	83	6880	137961	79599464
Nephrogenic systemic fibrosis	87.23	44.44	29	6934	6131	79731294
Type I hypersensitivity	84.03	44.44	26	6937	4372	79733053
Rash	80.61	44.44	164	6799	578194	79159231
Contrast media deposition	73.81	44.44	12	6951	96	79737329
Laryngeal discomfort	69.93	44.44	15	6948	585	79736840
Laryngeal oedema	68.38	44.44	26	6937	8103	79729322
Paraesthesia	65.88	44.44	79	6884	176244	79561181
Eyelid oedema	64.73	44.44	29	6934	13658	79723767
Anaphylactic reaction	55.51	44.44	51	6912	83692	79653733
Ocular hyperaemia	52.59	44.44	32	6931	28174	79709251
Nasal congestion	51.47	44.44	47	6916	76505	79660920
Off label use	51.00	44.44	9	6954	907206	78830219
Dysphonia	50.61	44.44	41	6922	56831	79680594
Flushing	49.46	44.44	49	6914	88219	79649206
Contrast media toxicity	48.72	44.44	7	6956	21	79737404
Burning sensation	47.44	44.44	40	6923	58592	79678833
Lacrimation increased	45.79	44.44	27	6936	22450	79714975

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Magnetic resonance imaging	indication	113091000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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
C0118538	UMLSCUI
CHEBI:73727	CHEBI
CHEMBL2219415	ChEMBL_ID
C072417	MESH_SUPPLEMENTAL_RECORD_UI
121841	PUBCHEM_CID
L0ND3981AG	UNII
1421151	RXNORM
29771	MMSL
361614	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
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
Gadoterate Meglumine	HUMAN PRESCRIPTION DRUG LABEL	1	65219-080	INJECTION	376.90 mg	INTRAVENOUS	ANDA	29 sections
Gadoterate Meglumine	HUMAN PRESCRIPTION DRUG LABEL	1	65219-082	INJECTION	376.90 mg	INTRAVENOUS	ANDA	29 sections
Gadoterate Meglumine	HUMAN PRESCRIPTION DRUG LABEL	1	65219-084	INJECTION	376.90 mg	INTRAVENOUS	ANDA	29 sections
Gadoterate Meglumine	HUMAN PRESCRIPTION DRUG LABEL	1	65219-086	INJECTION	376.90 mg	INTRAVENOUS	ANDA	29 sections
Gadoterate Meglumine	HUMAN PRESCRIPTION DRUG LABEL	1	65219-088	INJECTION	376.90 mg	INTRAVENOUS	ANDA	29 sections
DOTAREM	HUMAN PRESCRIPTION DRUG LABEL	1	67684-2000	Injection	376.90 mg	Intravenous	NDA	29 sections
DOTAREM	HUMAN PRESCRIPTION DRUG LABEL	1	67684-2000	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	67684-2001	Injection	376.90 mg	Intravenous	NDA	29 sections
DOTAREM	HUMAN PRESCRIPTION DRUG LABEL	1	67684-3001	Injection	376.90 mg	Intravenous	NDA	29 sections
DOTAREM	HUMAN PRESCRIPTION DRUG LABEL	1	67684-3001	Injection	376.90 mg	Intravenous	NDA	29 sections