gadobutrol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
diagnostic agents, gadolinium derivatives 4179 770691-21-9

Description:

MoleculeDescription

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:

PropertyValueReference
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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
March 14, 2011 FDA BAYER HLTHCARE

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Urticaria 1236.53 45.48 555 6357 312179 90309356
Pruritus 495.05 45.48 372 6540 541153 90080382
Contrast media reaction 425.53 45.48 75 6837 1176 90620359
Erythema 342.32 45.48 214 6698 229032 90392503
Contrast media allergy 295.39 45.48 64 6848 3017 90618518
Gadolinium deposition disease 278.08 45.48 38 6874 84 90621451
Throat irritation 267.26 45.48 110 6802 48585 90572950
Nausea 246.85 45.48 357 6555 1109959 89511576
Vomiting 222.35 45.48 285 6627 788008 89833527
Nontherapeutic agent urine positive 184.81 45.48 23 6889 13 90621522
Dyspnoea 175.77 45.48 270 6642 880685 89740850
Throat tightness 159.58 45.48 66 6846 29418 90592117
Sneezing 152.03 45.48 64 6848 29805 90591730
Contrast media deposition 137.52 45.48 19 6893 47 90621488
Eye swelling 126.68 45.48 56 6856 29330 90592205
Cough 121.87 45.48 145 6767 368817 90252718
Feeling hot 116.30 45.48 73 6839 77935 90543600
Anaphylactic shock 83.41 45.48 43 6869 31574 90589961
Anaphylactic reaction 78.64 45.48 60 6852 87464 90534071
Contrast media toxicity 76.07 45.48 10 6902 14 90621521
Oropharyngeal discomfort 73.07 45.48 26 6886 7709 90613826
Flushing 69.42 45.48 56 6856 88435 90533100
Cytokine increased 68.39 45.48 11 6901 95 90621440
Blood pressure decreased 64.33 45.48 50 6862 74845 90546690
Eyelid oedema 62.97 45.48 26 6886 11508 90610027
Lip swelling 62.22 45.48 38 6874 38572 90582963
Mitochondrial toxicity 59.21 45.48 13 6899 650 90620885
Drug ineffective 58.11 45.48 17 6895 1384281 89237254
Sensation of foreign body 54.88 45.48 20 6892 6346 90615189
Dizziness 54.63 45.48 131 6781 589153 90032382
Ocular hyperaemia 51.24 45.48 32 6880 33766 90587769
Eye pruritus 50.46 45.48 30 6882 28997 90592538
Burning sensation 47.31 45.48 39 6873 63413 90558122

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Urticaria 619.56 44.84 230 3262 73806 42544037
Vomiting 250.19 44.84 198 3294 289525 42328318
Nausea 230.51 44.84 216 3276 396583 42221260
Pruritus 215.87 44.84 153 3339 188618 42429225
Contrast media allergy 142.24 44.84 28 3464 759 42617084
Contrast media deposition 128.31 44.84 18 3474 47 42617796
Erythema 127.97 44.84 90 3402 108703 42509140
Contrast media reaction 121.09 44.84 26 3466 1090 42616753
Sneezing 108.73 44.84 34 3458 6329 42611514
Throat irritation 102.59 44.84 39 3453 12997 42604846
Nontherapeutic agent urine positive 89.87 44.84 11 3481 3 42617840
Gadolinium deposition disease 78.05 44.84 11 3481 30 42617813
Feeling hot 71.54 44.84 36 3456 23446 42594397
Throat tightness 65.83 44.84 26 3466 9573 42608270
Cold sweat 51.83 44.84 23 3469 11307 42606536
Swelling face 49.98 44.84 30 3462 27524 42590319
Hyperhidrosis 49.30 44.84 48 3444 90464 42527379
Anaphylactic reaction 49.22 44.84 35 3457 42708 42575135
Dyspnoea 49.12 44.84 110 3382 442511 42175332

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Urticaria 1686.73 38.65 734 9398 318123 110261044
Pruritus 694.29 38.65 505 9627 581055 109998112
Contrast media reaction 452.00 38.65 90 10042 2308 110576859
Erythema 417.45 38.65 284 9848 291163 110288004
Nausea 400.64 38.65 524 9608 1235166 109344001
Contrast media allergy 386.26 38.65 84 10048 3339 110575828
Vomiting 367.92 38.65 432 9700 910243 109668924
Gadolinium deposition disease 331.96 38.65 47 10085 115 110579052
Throat irritation 321.57 38.65 136 9996 53416 110525751
Contrast media deposition 241.66 38.65 34 10098 78 110579089
Nontherapeutic agent urine positive 230.26 38.65 30 10102 26 110579141
Sneezing 218.10 38.65 89 10043 31895 110547272
Dyspnoea 195.72 38.65 356 9776 1106516 109472651
Throat tightness 194.10 38.65 83 10049 33406 110545761
Feeling hot 154.60 38.65 99 10033 91007 110488160
Cough 140.35 38.65 191 9941 461450 110117717
Eye swelling 137.54 38.65 65 10067 32983 110546184
Anaphylactic reaction 123.11 38.65 94 10038 114206 110464961
Contrast media toxicity 113.59 38.65 15 10117 16 110579151
Anaphylactic shock 107.71 38.65 64 10068 51482 110527685
Flushing 91.09 38.65 76 10056 104660 110474507
Oropharyngeal discomfort 88.78 38.65 34 10098 10293 110568874
Dizziness 86.05 38.65 194 9938 697999 109881168
Drug ineffective 81.20 38.65 20 10112 1520520 109058647
Blood pressure decreased 80.93 38.65 74 10058 115017 110464150
Cytokine increased 75.09 38.65 14 10118 250 110578917
Lip swelling 71.22 38.65 49 10083 50618 110528549
Eye pruritus 69.25 38.65 41 10091 32734 110546433
Swelling face 68.11 38.65 61 10071 92260 110486907
Unresponsive to stimuli 67.61 38.65 52 10080 63738 110515429
Ocular hyperaemia 67.34 38.65 43 10089 39243 110539924
Loss of consciousness 66.79 38.65 86 10046 196220 110382947
Cold sweat 64.09 38.65 34 10098 21997 110557170
Hyperhidrosis 63.63 38.65 82 10050 187216 110391951
Rash 62.88 38.65 191 9941 820773 109758394
Eyelid oedema 60.37 38.65 29 10103 15233 110563934
Dysphonia 59.66 38.65 52 10080 75877 110503290
Paraesthesia 57.47 38.65 96 10036 276425 110302742
Pneumonia 56.51 38.65 7 10125 876707 109702460
Pallor 55.44 38.65 44 10088 56423 110522744
Chest discomfort 54.22 38.65 73 10059 173775 110405392
Sensation of foreign body 53.66 38.65 22 10110 7953 110571214
Burning sensation 53.57 38.65 47 10085 69165 110510002
Dysphagia 50.20 38.65 66 10066 153534 110425633
Nontherapeutic agent blood positive 49.79 38.65 6 10126 0 110579167
Mitochondrial toxicity 48.08 38.65 16 10116 3229 110575938
Hyperintensity in brain deep nuclei 46.75 38.65 9 10123 192 110578975
Rash macular 46.46 38.65 34 10098 38652 110540515
Foaming at mouth 45.15 38.65 14 10118 2256 110576911
Off label use 42.63 38.65 45 10087 1500140 109079027
Hypoaesthesia oral 40.50 38.65 23 10109 16979 110562188
Condition aggravated 40.38 38.65 9 10123 734827 109844340

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:37335 MRI contrast agent

Related Drugs by ATC class:

V08CA Paramagnetic contrast media 10 drugs
gadobenic acidgadodiamidegadofosvesetgadopentetate dimegluminegadopiclenolgadoteric acidgadoteridolgadoversetamidegadoxetic acidmangafodipir

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

DiseaseRelationSNOMED_IDDOID
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:

IDSource
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
1BJ477IO2L INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 42337-005 INJECTION 604.72 mg INTRAVENOUS ANDA 29 sections
gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 42337-006 INJECTION 604.72 mg INTRAVENOUS ANDA 29 sections
gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 42337-007 INJECTION 604.72 mg INTRAVENOUS ANDA 29 sections
Gadavist HUMAN PRESCRIPTION DRUG LABEL 1 50419-325 INJECTION 604.72 mg INTRAVENOUS NDA 32 sections
Gadavist HUMAN PRESCRIPTION DRUG LABEL 1 50419-325 INJECTION 604.72 mg INTRAVENOUS NDA 32 sections
Gadavist HUMAN PRESCRIPTION DRUG LABEL 1 50419-325 INJECTION 604.72 mg INTRAVENOUS NDA 32 sections
Gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 65219-281 INJECTION 604.72 mg INTRAVENOUS ANDA 29 sections
Gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 65219-287 INJECTION 604.72 mg INTRAVENOUS ANDA 31 sections
Gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 65219-289 INJECTION 604.72 mg INTRAVENOUS ANDA 31 sections
gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 70436-212 INJECTION 604.72 mg INTRAVENOUS ANDA 30 sections
gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 70436-213 INJECTION 604.72 mg INTRAVENOUS ANDA 30 sections
gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 70436-214 INJECTION 604.72 mg INTRAVENOUS ANDA 30 sections
gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 70436-216 INJECTION 604.72 mg INTRAVENOUS ANDA 30 sections
gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 70436-216 INJECTION 604.72 mg INTRAVENOUS ANDA 30 sections
gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 70436-217 INJECTION 604.72 mg INTRAVENOUS ANDA 30 sections
gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 70436-217 INJECTION 604.72 mg INTRAVENOUS ANDA 30 sections
gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 70436-218 INJECTION 604.72 mg INTRAVENOUS ANDA 30 sections
gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 70710-2064 INJECTION 604.72 mg INTRAVENOUS ANDA 26 sections
gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 70710-2065 INJECTION 604.72 mg INTRAVENOUS ANDA 26 sections
gadobutrol HUMAN PRESCRIPTION DRUG LABEL 1 70710-2066 INJECTION 604.72 mg INTRAVENOUS ANDA 26 sections