gadobenate dimeglumine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
diagnostic agents, gadolinium derivatives	4471	127000-20-8

Description:

Molecule	Description
Synonyms: multihance gadobenate dimeglumine	Molecular weight: 1058.16 Formula: C36H62GdN5O21 CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Nov. 23, 2004	FDA	BRACCO

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
Nephrogenic systemic fibrosis	551.25	54.28	120	4956	4647	53339343
Hypersensitivity	380.75	54.28	240	4836	210425	53133565
Contrast media reaction	290.80	54.28	55	5021	1028	53342962
Urticaria	288.59	54.28	172	4904	135713	53208277
Skin hypertrophy	252.40	54.28	59	5017	3140	53340850
Anaphylactic reaction	234.24	54.28	113	4963	58213	53285777
Skin induration	222.20	54.28	53	5023	3077	53340913
Skin tightness	198.78	54.28	51	5025	4000	53339990
Anaphylactoid reaction	197.98	54.28	50	5026	3681	53340309
Sneezing	174.96	54.28	62	5014	14610	53329380
Pruritus	154.16	54.28	163	4913	293669	53050321
Vomiting	145.43	54.28	205	4871	496934	52847056
Skin fibrosis	138.87	54.28	29	5047	910	53343080
Erythema	137.74	54.28	116	4960	156853	53187137
Fibrosis	123.82	54.28	35	5041	3957	53340033
Nausea	117.81	54.28	235	4841	755856	52588134
Throat tightness	88.83	54.28	43	5033	22173	53321817
Throat irritation	85.30	54.28	47	5029	31634	53312356
Feeling hot	83.60	54.28	51	5025	41493	53302497
Skin hyperpigmentation	75.35	54.28	26	5050	5646	53338344
Dyspnoea	73.15	54.28	167	4909	586065	52757925
Joint range of motion decreased	72.51	54.28	35	5041	17921	53326069
Gadolinium deposition disease	72.40	54.28	11	5065	48	53343942
Joint contracture	70.85	54.28	19	5057	1765	53342225
Scar	67.66	54.28	30	5046	12663	53331327
Peau d'orange	67.34	54.28	12	5064	158	53343832
Anaphylactic shock	65.94	54.28	35	5041	21858	53322132
Emotional distress	65.83	54.28	40	5036	32277	53311713
Contrast media allergy	63.66	54.28	18	5058	2034	53341956
Foaming at mouth	63.12	54.28	16	5060	1192	53342798
Anhedonia	56.13	54.28	25	5051	10662	53333328
Skin discolouration	55.35	54.28	37	5039	35155	53308835

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
Nephrogenic systemic fibrosis	379.27	63.81	87	3028	4265	32506146
Hypersensitivity	291.63	63.81	131	2984	57627	32452784
Urticaria	173.43	63.81	93	3022	59521	32450890
Vomiting	169.11	63.81	155	2960	235402	32275009
Anaphylactic reaction	163.16	63.81	72	3043	30100	32480311
Skin induration	159.36	63.81	38	3077	2190	32508221
Skin hypertrophy	158.41	63.81	39	3076	2572	32507839
Sneezing	158.08	63.81	44	3071	4687	32505724
Nausea	156.44	63.81	171	2944	320678	32189733
Anaphylactoid reaction	147.76	63.81	36	3079	2272	32508139
Skin tightness	146.17	63.81	35	3080	2052	32508359
Contrast media reaction	140.63	63.81	29	3086	850	32509561
Joint contracture	107.68	63.81	27	3088	1916	32508495
Joint range of motion decreased	96.42	63.81	32	3083	6150	32504261
Fibrosis	95.63	63.81	26	3089	2531	32507880
Skin fibrosis	90.86	63.81	21	3094	1053	32509358
Scar	85.93	63.81	29	3086	5864	32504547
Pruritus	80.79	63.81	79	3036	128623	32381788
Anaphylactic shock	78.29	63.81	35	3080	14999	32495412
Extremity contracture	74.83	63.81	17	3098	789	32509622
Deformity	72.81	63.81	19	3096	1579	32508832

Pharmacologic Action:

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

Drug Use (View source of the data)

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
4032768	VUID
N0000188993	NUI
4032768	VANDF
CHEMBL1200571	ChEMBL_ID
C064572	MESH_SUPPLEMENTAL_RECORD_UI
3Q6PPC19PO	UNII
24838350	PUBCHEM_CID
68173	RXNORM
19178	MMSL
64278	MMSL
64293	MMSL
d05428	MMSL
007717	NDDF
414308003	SNOMEDCT_US
C0209453	UMLSCUI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
MultiHance	HUMAN PRESCRIPTION DRUG LABEL	1	0270-5164	INJECTION, SOLUTION	529 mg	INTRAVENOUS	NDA	28 sections
MultiHance	HUMAN PRESCRIPTION DRUG LABEL	1	0270-5264	INJECTION, SOLUTION	529 mg	INTRAVENOUS	NDA	27 sections