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

Stem definition	Drug id	CAS RN
diagnostic agents, gadolinium derivatives	4179	770691-21-9

Description:

Molecule	Description
Synonyms: gadobutrol gadavist gadograf gadovist protovist	Gadobutrol is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients (including term neonates) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. Molecular weight: 604.72 Formula: C18H31GdN4O9 CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: 181.08 ALOGS: ROTB: None

Molecule

Description

Synonyms:

gadobutrol
gadavist
gadograf
gadovist
protovist

Gadobutrol is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients (including term neonates) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.

Molecular weight: 604.72
Formula: C18H31GdN4O9
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA: 181.08
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

Property	Value	Reference
Vd (Volume of distribution)	0.22 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	1 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.30 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
March 14, 2011	FDA	BAYER HLTHCARE

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	1219.14	50.96	473	4968	165329	63318252
Pruritus	428.26	50.96	304	5137	361149	63122432
Contrast media reaction	294.43	50.96	55	5386	1070	63482511
Erythema	261.77	50.96	171	5270	175580	63308001
Gadolinium deposition disease	256.49	50.96	35	5406	64	63483517
Vomiting	224.78	50.96	256	5185	559361	62924220
Nausea	220.34	50.96	313	5128	854158	62629423
Contrast media allergy	192.45	50.96	44	5397	2357	63481224
Nontherapeutic agent urine positive	173.86	50.96	22	5419	13	63483568
Throat irritation	171.01	50.96	77	5364	37570	63446011
Sneezing	139.16	50.96	54	5387	18164	63465417
Contrast media deposition	135.31	50.96	19	5422	47	63483534
Dyspnoea	130.69	50.96	215	5226	661098	62822483
Feeling hot	113.23	50.96	64	5377	50290	63433291
Eye swelling	102.46	50.96	47	5394	23871	63459710
Throat tightness	100.68	50.96	47	5394	24840	63458741
Contrast media toxicity	75.77	50.96	10	5431	12	63483569
Cough	75.38	50.96	108	5333	292635	63190946
Cytokine increased	72.66	50.96	11	5430	53	63483528
Anaphylactic reaction	69.15	50.96	52	5389	66048	63417533
Mitochondrial toxicity	61.86	50.96	13	5428	468	63483113

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	519.74	46.86	190	2507	62187	34892047
Vomiting	236.33	46.86	175	2522	247446	34706788
Nausea	219.66	46.86	191	2506	339717	34614517
Pruritus	187.80	46.86	123	2574	141858	34812376
Contrast media deposition	122.32	46.86	17	2680	44	34954190
Contrast media allergy	106.15	46.86	20	2677	455	34953779
Erythema	102.65	46.86	71	2626	88709	34865525
Sneezing	95.46	46.86	29	2668	5213	34949021
Contrast media reaction	81.27	46.86	18	2679	928	34953306
Gadolinium deposition disease	72.48	46.86	10	2687	24	34954210
Throat irritation	71.93	46.86	28	2669	10557	34943677
Nontherapeutic agent urine positive	65.22	46.86	8	2689	3	34954231
Feeling hot	58.63	46.86	29	2668	19343	34934891

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	1563.89	39.32	608	7260	184593	79551927
Pruritus	591.11	39.32	405	7463	394243	79342277
Vomiting	351.91	39.32	376	7492	665452	79071068
Nausea	350.46	39.32	447	7421	956749	78779771
Erythema	317.81	39.32	223	7645	223067	79513453
Gadolinium deposition disease	307.18	39.32	43	7825	84	79736436
Contrast media reaction	298.55	39.32	63	7805	2007	79734513
Contrast media allergy	253.19	39.32	57	7811	2465	79734055
Contrast media deposition	232.34	39.32	33	7835	75	79736445
Sneezing	212.36	39.32	78	7790	19605	79716915
Nontherapeutic agent urine positive	211.93	39.32	28	7840	26	79736494
Throat irritation	203.23	39.32	93	7775	40853	79695667
Feeling hot	145.47	39.32	84	7784	59650	79676870
Dyspnoea	131.44	39.32	271	7597	856754	78879766
Throat tightness	118.66	39.32	57	7811	27850	79708670
Eye swelling	106.32	39.32	52	7816	26416	79710104
Contrast media toxicity	105.44	39.32	14	7854	14	79736506
Anaphylactic reaction	96.77	39.32	74	7794	83669	79652851
Cough	86.28	39.32	140	7728	366649	79369871
Cytokine increased	83.85	39.32	14	7854	117	79736403
Eye pruritus	69.63	39.32	36	7832	20534	79715986
Drug ineffective	62.77	39.32	15	7853	1080898	78655622
Flushing	62.75	39.32	59	7809	88209	79648311
Dizziness	62.71	39.32	151	7717	526290	79210230
Rash	59.60	39.32	157	7711	578201	79158319
Oropharyngeal discomfort	57.83	39.32	23	7845	7143	79729377
Paraesthesia	53.67	39.32	76	7792	176247	79560273
Anaphylactic shock	53.33	39.32	37	7831	35959	79700561
Hyperhidrosis	51.68	39.32	69	7799	151423	79585097
Lip swelling	51.31	39.32	38	7830	40873	79695647
Swelling face	49.45	39.32	47	7821	71165	79665355
Nontherapeutic agent blood positive	49.35	39.32	6	7862	0	79736520
Mitochondrial toxicity	47.57	39.32	16	7852	3098	79733422
Ocular hyperaemia	46.56	39.32	31	7837	28175	79708345
Hyperintensity in brain deep nuclei	46.50	39.32	9	7859	183	79736337
Burning sensation	45.16	39.32	41	7827	58591	79677929
Pneumonia	42.75	39.32	7	7861	660239	79076281
Pallor	42.51	39.32	37	7831	50025	79686495
Rash macular	41.16	39.32	29	7839	28870	79707650
Dysphonia	40.37	39.32	38	7830	56834	79679686
Blood pressure decreased	39.71	39.32	49	7819	99417	79637103
Cold sweat	39.45	39.32	24	7844	18675	79717845

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	V08CA09	VARIOUS CONTRAST MEDIA MAGNETIC RESONANCE IMAGING CONTRAST MEDIA Paramagnetic contrast media
MeSH PA	D003287	Contrast Media
MeSH PA	D064907	Diagnostic Uses of Chemicals
FDA MoA	N0000175862	Magnetic Resonance Contrast Activity
FDA EPC	N0000183362	Gadolinium-based Contrast Agent

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
4030851	VUID
N0000183361	NUI
D07420	KEGG_DRUG
4030851	VANDF
C0291216	UMLSCUI
CHEBI:68841	CHEBI
CHEMBL2218860	ChEMBL_ID
DB06703	DRUGBANK_ID
C090600	MESH_SUPPLEMENTAL_RECORD_UI
6882	INN_ID
1BJ477IO2L	UNII
6102852	PUBCHEM_CID
84990	RXNORM
180514	MMSL
18728	MMSL
369624	MMSL
d05346	MMSL
008334	NDDF
407976008	SNOMEDCT_US
418351005	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadavist	HUMAN PRESCRIPTION DRUG LABEL	1	50419-325	INJECTION	604.72 mg	INTRAVENOUS	NDA	28 sections
Gadobutrol	HUMAN PRESCRIPTION DRUG LABEL	1	65219-281	INJECTION	604.72 mg	INTRAVENOUS	ANDA	28 sections
gadobutrol	HUMAN PRESCRIPTION DRUG LABEL	1	70436-122	INJECTION	604.72 mg	INTRAVENOUS	ANDA	29 sections