gadodiamide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
diagnostic agents, gadolinium derivatives	4494	131410-48-5

Description:

Molecule	Description
Synonyms: omniscan gadodiamide	for intravenous administration with MRI in adult patients for contrast enhancement of CNS lesions Molecular weight: 573.66 Formula: C16H26GdN5O8 CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

omniscan
gadodiamide

for intravenous administration with MRI in adult patients for contrast enhancement of CNS lesions

Molecular weight: 573.66
Formula: C16H26GdN5O8
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
CL (Clearance)	1.79 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.46 hours	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.20 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Jan. 8, 1993	FDA	GE HEALTHCARE

FDA Adverse Event Reporting System (Female)

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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
Nephrogenic systemic fibrosis	2250.51	48.76	349	2661	4207	63481805
Skin hypertrophy	411.79	48.76	79	2931	3312	63482700
Skin induration	409.52	48.76	78	2932	3145	63482867
Skin tightness	310.37	48.76	65	2945	4251	63481761
Skin fibrosis	214.41	48.76	37	2973	843	63485169
Fibrosis	199.54	48.76	45	2965	4147	63481865
Skin hyperpigmentation	153.96	48.76	39	2971	5882	63480130
Joint contracture	129.81	48.76	27	2983	1697	63484315
Joint range of motion decreased	129.54	48.76	51	2959	32377	63453635
Scar	105.18	48.76	35	2975	13747	63472265

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FDA Adverse Event Reporting System (Male)

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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
Nephrogenic systemic fibrosis	2332.22	47.16	387	2811	3618	34950115
Skin hypertrophy	385.81	47.16	80	3118	2549	34951184
Skin induration	365.86	47.16	74	3124	2077	34951656
Skin tightness	362.44	47.16	74	3124	2179	34951554
Joint contracture	243.41	47.16	52	3146	1909	34951824
Joint range of motion decreased	243.02	47.16	67	3131	7245	34946488
Skin fibrosis	225.90	47.16	44	3154	1008	34952725
Fibrosis	182.07	47.16	43	3155	2493	34951240
Scar	167.96	47.16	48	3150	5896	34947837
Extremity contracture	132.91	47.16	27	3171	769	34952964

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FDA Adverse Event Reporting System (Geriatric)

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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
Nephrogenic systemic fibrosis	3162.99	54.84	504	4269	5656	79733959
Skin hypertrophy	627.02	54.84	124	4649	4804	79734811
Skin induration	600.81	54.84	118	4655	4407	79735208
Skin tightness	536.27	54.84	111	4662	5411	79734204
Skin fibrosis	342.84	54.84	62	4711	1462	79738153
Joint contracture	293.60	54.84	59	4714	2465	79737150
Joint range of motion decreased	267.31	54.84	93	4680	33189	79706426
Fibrosis	244.67	54.84	58	4715	5251	79734364
Scar	196.84	54.84	61	4712	15135	79724480
Biopsy brain abnormal	176.47	54.84	21	4752	8	79739607

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	V08CA03	VARIOUS CONTRAST MEDIA MAGNETIC RESONANCE IMAGING CONTRAST MEDIA Paramagnetic contrast media
FDA EPC	N0000180184	Paramagnetic Contrast Agent
FDA MoA	N0000175862	Magnetic Resonance Contrast Activity
MeSH PA	D003287	Contrast Media
MeSH PA	D064907	Diagnostic Uses of Chemicals

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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:

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ID	Source
004259	NDDF
10205	MMSL
153921	PUBCHEM_CID
354088005	SNOMEDCT_US
396067007	SNOMEDCT_US
4020689	VUID
4020689	VANDF
41144	RXNORM
4771	MMSL
6636	INN_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
OMNISCAN	HUMAN PRESCRIPTION DRUG LABEL	1	0407-0690	INJECTION	287 mg	INTRAVENOUS	NDA	28 sections
OMNISCAN	HUMAN PRESCRIPTION DRUG LABEL	1	0407-0690	INJECTION	287 mg	INTRAVENOUS	NDA	28 sections
OMNISCAN	HUMAN PRESCRIPTION DRUG LABEL	1	0407-0690	INJECTION	287 mg	INTRAVENOUS	NDA	28 sections
OMNISCAN	HUMAN PRESCRIPTION DRUG LABEL	1	0407-0690	INJECTION	287 mg	INTRAVENOUS	NDA	28 sections
OMNISCAN	HUMAN PRESCRIPTION DRUG LABEL	1	0407-0690	INJECTION	287 mg	INTRAVENOUS	NDA	28 sections
OMNISCAN	HUMAN PRESCRIPTION DRUG LABEL	1	0407-0690	INJECTION	287 mg	INTRAVENOUS	NDA	28 sections
OMNISCAN	HUMAN PRESCRIPTION DRUG LABEL	1	0407-0691	INJECTION	287 mg	INTRAVENOUS	NDA	28 sections
OMNISCAN	HUMAN PRESCRIPTION DRUG LABEL	1	0407-0691	INJECTION	287 mg	INTRAVENOUS	NDA	28 sections

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