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

Stem definitionDrug idCAS RN
4106 54182-58-0

Description:

MoleculeDescription

Synonyms:

  • sucralfate
  • antepsin
  • carafate
  • sucralfin
  • sucrate
  • sulcrate
  • ulcerlmin
  • ulcogant
A basic aluminum complex of sulfated sucrose.
  • Molecular weight:
  • Formula: None
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
4 g O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Oct. 30, 1981 FDA FOREST LABS INC

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
Drug ineffective 74.70 11.59 188 24943 819145 49760848
Cholecystitis chronic 65.05 11.59 47 25084 9622 50570371
Gastritis 60.19 11.59 78 25053 32905 50547088
Contraindicated product administered 50.56 11.59 7 25124 148951 50431042
Angina bullosa haemorrhagica 49.55 11.59 12 25119 132 50579861
Abdominal pain 44.46 11.59 233 24898 235995 50343998
Joint swelling 40.87 11.59 37 25094 245249 50334744
Abdominal pain upper 40.86 11.59 172 24959 159137 50420856
Toxicity to various agents 40.50 11.59 28 25103 212471 50367522
Facial asymmetry 38.77 11.59 14 25117 652 50579341
Hand deformity 38.38 11.59 3 25128 100196 50479797
Muscle swelling 37.71 11.59 12 25119 378 50579615
Oesophagitis 36.68 11.59 39 25092 13344 50566649
Nausea 35.90 11.59 519 24612 704879 49875114
Impaired gastric emptying 34.37 11.59 31 25100 8687 50571306
Gastrooesophageal reflux disease 33.94 11.59 99 25032 76329 50503664
Early satiety 33.19 11.59 13 25118 759 50579234
Exposure during pregnancy 32.21 11.59 10 25121 121005 50458988
Glossodynia 31.77 11.59 9 25122 115560 50464433
Lower respiratory tract infection 31.08 11.59 5 25126 95196 50484797
Vulval disorder 30.68 11.59 12 25119 698 50579295
Dehydration 29.77 11.59 152 24979 152297 50427696
Vaginal flatulence 29.61 11.59 9 25122 243 50579750
Cholelithiasis 29.50 11.59 61 25070 37912 50542081
Treatment failure 29.17 11.59 16 25115 137621 50442372
Systemic lupus erythematosus 28.87 11.59 17 25114 140605 50439388
Pericarditis 28.40 11.59 3 25128 78686 50501307
Gastric ulcer 27.90 11.59 43 25088 21262 50558731
Rheumatoid arthritis 26.67 11.59 37 25094 202513 50377480
Tarsal tunnel syndrome 26.48 11.59 10 25121 529 50579464
Gastrointestinal haemorrhage 26.12 11.59 88 25043 73233 50506760
Musculoskeletal stiffness 25.72 11.59 16 25115 128465 50451528
Completed suicide 25.62 11.59 17 25114 131872 50448121
Genotype drug resistance test positive 24.28 11.59 8 25123 282 50579711
Diarrhoea 24.16 11.59 418 24713 588058 49991935
Gallbladder disorder 23.64 11.59 35 25096 16707 50563286
Weight decreased 23.52 11.59 189 24942 221056 50358937
Vomiting 23.31 11.59 339 24792 460419 50119574
Movement disorder 22.27 11.59 35 25096 17597 50562396
Haematemesis 22.08 11.59 45 25086 27680 50552313
Proctitis 21.87 11.59 13 25118 1915 50578078
Off label use 21.38 11.59 143 24988 474283 50105710
Intentional overdose 21.05 11.59 3 25128 62501 50517492
Wound 20.05 11.59 14 25117 105780 50474213
Product use issue 19.97 11.59 27 25104 149448 50430545
Purpura senile 19.59 11.59 8 25123 521 50579472
Product dose omission issue 18.96 11.59 156 24975 183682 50396311
Constipation 18.84 11.59 157 24974 185551 50394442
Liver abscess 18.35 11.59 13 25118 2580 50577413
Haemoglobin decreased 18.33 11.59 117 25014 127099 50452894
Blood magnesium decreased 18.21 11.59 25 25106 11135 50568858
Hepatic enzyme increased 18.16 11.59 25 25106 137355 50442638
Colitis 18.15 11.59 51 25080 38478 50541515
Paranoia 18.14 11.59 24 25107 10324 50569669
Drug intolerance 17.75 11.59 53 25078 219051 50360942
Therapeutic product effect decreased 17.75 11.59 25 25106 136025 50443968
Faeces discoloured 17.64 11.59 30 25101 16094 50563899
Migraine 17.53 11.59 79 25052 75201 50504792
Blood alkaline phosphatase increased 17.02 11.59 49 25082 37477 50542516
Frequent bowel movements 16.71 11.59 27 25104 13891 50566102
Female genital tract fistula 16.38 11.59 14 25117 3652 50576341
Biliary dyskinesia 16.25 11.59 12 25119 2538 50577455
Therapeutic product effect incomplete 16.20 11.59 13 25118 91502 50488491
Infusion related reaction 16.01 11.59 38 25093 169519 50410474
Drug abuse 15.82 11.59 5 25126 59841 50520152
Pancreatic enzyme abnormality 15.67 11.59 3 25128 9 50579984
Vestibular disorder 15.56 11.59 9 25122 1260 50578733
Gallbladder injury 15.40 11.59 9 25122 1285 50578708
Vascular rupture 15.06 11.59 9 25122 1338 50578655
General physical health deterioration 15.04 11.59 30 25101 142404 50437589
Flatulence 14.88 11.59 40 25091 29418 50550575
Hiatus hernia 14.87 11.59 30 25101 18314 50561679
Memory impairment 14.69 11.59 78 25053 79282 50500711
Resorption bone increased 14.65 11.59 8 25123 1003 50578990
Hallucination, auditory 14.53 11.59 22 25109 10706 50569287
Arthropathy 14.43 11.59 36 25095 157870 50422123
Cellulitis 14.08 11.59 71 25060 70727 50509266
Blister 14.06 11.59 13 25118 85405 50494588
Peptic ulcer 13.79 11.59 13 25118 3853 50576140
Drug interaction 13.63 11.59 52 25079 199569 50380424
Chest pain 13.62 11.59 141 24990 176741 50403252
Crepitations 13.41 11.59 16 25115 6203 50573790
Urinary tract infection 13.40 11.59 170 24961 223850 50356143
Ulcer haemorrhage 13.34 11.59 12 25119 3349 50576644
Pancreatitis 13.32 11.59 49 25082 42565 50537428
Discomfort 13.08 11.59 21 25110 108359 50471634
Upper respiratory tract infection 13.05 11.59 66 25065 65832 50514161
Alopecia 13.04 11.59 70 25061 244977 50335016
Gastric haemorrhage 12.86 11.59 15 25116 5681 50574312
Radiculopathy 12.84 11.59 14 25117 4927 50575066
Ocular neoplasm 12.67 11.59 5 25126 298 50579695
Hyperacusis 12.66 11.59 9 25122 1795 50578198
Blood pressure diastolic increased 12.64 11.59 17 25114 7426 50572567
Muscle spasms 12.64 11.59 106 25025 125447 50454546
Burning sensation 12.36 11.59 50 25081 45396 50534597
Overdose 12.34 11.59 19 25112 99708 50480285
Platelet count decreased 12.33 11.59 89 25042 100637 50479356
Dysphagia 12.23 11.59 73 25058 77445 50502548
Angiodysplasia 12.20 11.59 5 25126 329 50579664
Lithiasis 11.93 11.59 3 25128 39 50579954
Colitis ulcerative 11.85 11.59 26 25105 16828 50563165
Oesophageal ulcer 11.71 11.59 12 25119 3933 50576060
Infusion site swelling 11.60 11.59 16 25115 7160 50572833

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
Gastrointestinal haemorrhage 44.15 11.83 101 12355 79432 29482639
Blood aluminium increased 38.21 11.83 6 12450 3 29562068
Oesophagitis 32.31 11.83 32 12424 11891 29550180
Completed suicide 27.44 11.83 3 12453 90243 29471828
Gastrooesophageal reflux disease 27.04 11.83 48 12408 31448 29530623
Dysphagia 24.33 11.83 64 12392 54862 29507209
Brugada syndrome 22.05 11.83 9 12447 692 29561379
Vomiting 21.00 11.83 157 12299 212103 29349968
Gastric mucosal calcinosis 20.32 11.83 3 12453 0 29562071
Toxicity to various agents 19.32 11.83 27 12429 173634 29388437
Nausea 16.01 11.83 189 12267 289066 29273005
Decreased appetite 15.78 11.83 110 12346 145232 29416839
Dyspepsia 15.31 11.83 37 12419 30088 29531983
Off label use 15.29 11.83 70 12386 300730 29261341
Gastrointestinal pain 15.26 11.83 11 12445 2648 29559423
Dehydration 14.36 11.83 90 12366 114658 29447413
COVID-19 treatment 14.12 11.83 5 12451 260 29561811
Muscle twitching 13.85 11.83 17 12439 8009 29554062
Oesophageal ulcer 13.69 11.83 11 12445 3109 29558962
Pneumonia 13.07 11.83 198 12258 319974 29242097
Asthenia 12.94 11.83 143 12313 215107 29346964
Adenocarcinoma gastric 12.45 11.83 7 12449 1096 29560975
Joint dislocation reduction 12.21 11.83 3 12453 42 29562029
Asthma-chronic obstructive pulmonary disease overlap syndrome 12.04 11.83 6 12450 737 29561334
Eating disorder 11.94 11.83 15 12441 7232 29554839
Oesophageal pain 11.92 11.83 6 12450 752 29561319
Blood loss anaemia 11.91 11.83 15 12441 7251 29554820
Abdominal pain upper 11.84 11.83 54 12402 60939 29501132

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
Toxicity to various agents 57.48 10.83 48 29107 363465 64106112
Gastrointestinal haemorrhage 55.46 10.83 158 28997 132154 64337423
Cholecystitis chronic 54.39 10.83 40 29115 9247 64460330
Completed suicide 52.44 10.83 18 29137 224396 64245181
Oesophagitis 49.81 10.83 55 29100 21575 64448002
Gastritis 47.63 10.83 76 29079 42542 64427035
Blood aluminium increased 42.59 10.83 7 29148 6 64469571
Gastrooesophageal reflux disease 41.57 10.83 106 29049 83037 64386540
Nausea 40.31 10.83 536 28619 785264 63684313
Drug ineffective 39.58 10.83 221 28934 840026 63629551
Vomiting 38.45 10.83 399 28756 550718 63918859
Abdominal pain upper 37.01 10.83 167 28988 174863 64294714
Angina bullosa haemorrhagica 36.86 10.83 10 29145 196 64469381
Abdominal pain 35.97 10.83 253 28902 312122 64157455
Off label use 35.15 10.83 157 28998 632649 63836928
Impaired gastric emptying 34.59 10.83 30 29125 8774 64460803
Facial asymmetry 31.96 10.83 12 29143 687 64468890
Early satiety 29.49 10.83 13 29142 1126 64468451
Contraindicated product administered 28.19 10.83 7 29148 107822 64361755
Vulval disorder 28.15 10.83 10 29145 489 64469088
Drug abuse 27.03 10.83 13 29142 132361 64337216
Haemoglobin decreased 26.67 10.83 165 28990 194898 64274679
Dehydration 25.76 10.83 177 28978 216586 64252991
Overdose 25.26 10.83 21 29134 159545 64310032
Cholelithiasis 24.83 10.83 60 29095 45446 64424131
Muscle swelling 24.45 10.83 10 29145 720 64468857
Dysphagia 24.14 10.83 104 29051 106708 64362869
Joint swelling 23.67 10.83 38 29117 215344 64254233
Haematemesis 23.57 10.83 60 29095 46939 64422638
Tarsal tunnel syndrome 20.68 10.83 8 29147 497 64469080
Purpura senile 20.59 10.83 8 29147 503 64469074
Oesophageal ulcer 20.15 10.83 19 29136 6191 64463386
Intentional overdose 19.67 10.83 8 29147 89936 64379641
Ulcer haemorrhage 19.06 10.83 16 29139 4476 64465101
Gastric ulcer 18.84 10.83 42 29113 30192 64439385
Blood alkaline phosphatase increased 18.69 10.83 62 29093 56217 64413360
Hand deformity 18.64 10.83 3 29152 62768 64406809
Pericarditis 18.54 10.83 3 29152 62513 64407064
Diarrhoea 18.54 10.83 442 28713 722262 63747315
Gallbladder disorder 18.51 10.83 30 29125 17000 64452577
Lower respiratory tract infection 18.25 10.83 10 29145 94604 64374973
Infusion related reaction 18.08 10.83 29 29126 164438 64305139
Biliary dyskinesia 18.06 10.83 12 29143 2360 64467217
Weight decreased 18.04 10.83 203 28952 285536 64184041
Constipation 17.83 10.83 170 28985 229167 64240410
Brugada syndrome 17.73 10.83 9 29146 1069 64468508
Product dose omission issue 17.51 10.83 149 29006 194598 64274979
Exposure during pregnancy 16.84 10.83 7 29148 77668 64391909
Hiatus hernia 16.30 10.83 31 29124 19926 64449651
Gastrointestinal pain 15.30 10.83 18 29137 7556 64462021
Genotype drug resistance test positive 15.12 10.83 8 29147 1036 64468541
Gastric haemorrhage 15.00 10.83 24 29131 13457 64456120
Oesophageal stenosis 14.93 10.83 13 29142 3821 64465756
Drug intolerance 14.87 10.83 40 29115 187952 64281625
Short-bowel syndrome 14.80 10.83 6 29149 422 64469155
Gastric disorder 14.35 10.83 37 29118 29160 64440417
Dyspepsia 14.32 10.83 73 29082 80239 64389338
Resorption bone increased 14.27 10.83 8 29147 1160 64468417
Musculoskeletal stiffness 14.23 10.83 21 29134 123185 64346392
Movement disorder 14.20 10.83 31 29124 21969 64447608
Blood potassium decreased 13.86 10.83 45 29110 40354 64429223
Systemic lupus erythematosus 13.85 10.83 9 29146 77603 64391974
Treatment failure 13.41 10.83 20 29135 116796 64352781
Ocular neoplasm 13.26 10.83 5 29150 290 64469287
Product use issue 12.99 10.83 31 29124 151684 64317893
Product use in unapproved indication 12.92 10.83 39 29116 176579 64292998
Gastric ulcer haemorrhage 12.70 10.83 17 29138 8126 64461451
Lactic acidosis 12.58 10.83 6 29149 61404 64408173
Upper respiratory tract infection 12.18 10.83 65 29090 72720 64396857
Drug interaction 12.12 10.83 105 29050 361978 64107599
Melaena 11.98 10.83 52 29103 53496 64416081
Gastrointestinal ulcer haemorrhage 11.95 10.83 7 29148 1103 64468474
Asthenia 11.92 10.83 265 28890 427779 64041798
Pneumonia 11.90 10.83 334 28821 559242 63910335
Upper gastrointestinal haemorrhage 11.87 10.83 39 29116 35181 64434396
Blood magnesium decreased 11.85 10.83 22 29133 13883 64455694
Bezoar 11.81 10.83 9 29146 2194 64467383
Paranoia 11.66 10.83 24 29131 16328 64453249
Rheumatoid arthritis 11.51 10.83 37 29118 164257 64305320
Vestibular disorder 11.49 10.83 9 29146 2284 64467293
Liver abscess 11.42 10.83 13 29142 5267 64464310
COVID-19 treatment 11.25 10.83 5 29150 442 64469135
Therapeutic product effect decreased 11.17 10.83 22 29133 115329 64354248
General physical health deterioration 11.12 10.83 51 29104 204374 64265203
Faeces discoloured 11.03 10.83 31 29124 25698 64443879
Angiodysplasia 11.02 10.83 6 29149 823 64468754

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A02BX02 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD)
FDA CS M0015420 Organometallic Compounds
MeSH PA D000897 Anti-Ulcer Agents
MeSH PA D005765 Gastrointestinal Agents
FDA EPC N0000175801 Aluminum Complex

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

DiseaseRelationSNOMED_IDDOID
Duodenal ulcer disease indication 51868009 DOID:1724
Maintenance of Healing Duodenal Ulcer indication
Gingivostomatitis off-label use 20607006
Peptic reflux disease off-label use 57643001
Stomatitis off-label use 61170000 DOID:9637
Gastroesophageal reflux disease off-label use 235595009 DOID:8534
Gastric ulcer off-label use 397825006 DOID:10808
NSAID-Induced Duodenal Ulcer off-label use
Sclerotherapy Induced Esophageal Ulcer off-label use
Stress-Related GI Mucosal Bleeding Prevention off-label use
Maintenance of Healing Gastric Ulcer off-label use
Prevention of Stress Ulcer off-label use
Sclerotherapy-Induced Mucositis off-label use
End stage renal disease contraindication 46177005 DOID:784
Hyperglycemia contraindication 80394007 DOID:4195
Aluminum intoxication contraindication 236546003




🐶 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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1GM/10ML SUCRALFATE VISTAPHARM A211884 March 15, 2022 RX SUSPENSION ORAL Sept. 11, 2022 COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Pepsin A-5 Enzyme INHIBITOR CHEMBL CHEMBL

External reference:

IDSource
4018816 VUID
N0000147119 NUI
4018816 VANDF
C0038633 UMLSCUI
CHEBI:9313 CHEBI
CHEMBL3989780 ChEMBL_ID
CHEMBL2367706 ChEMBL_ID
D013392 MESH_DESCRIPTOR_UI
DB00364 DRUGBANK_ID
7055 IUPHAR_LIGAND_ID
2723 INN_ID
XX73205DH5 UNII
134129852 PUBCHEM_CID
10156 RXNORM
1948 MMSL
476 MMSL
5518 MMSL
d00377 MMSL
001132 NDDF
387387008 SNOMEDCT_US
69967001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 0093-2210 TABLET 1 g ORAL ANDA 20 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 0121-0747 SUSPENSION 1 g ORAL NDA 20 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 0254-1011 SUSPENSION 1 g ORAL NDA authorized generic 19 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 0615-4517 TABLET 1 g ORAL ANDA 20 sections
SUCRALFATE HUMAN PRESCRIPTION DRUG LABEL 1 16590-523 TABLET 1 g ORAL ANDA 2 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 17856-0062 SUSPENSION 1 g ORAL ANDA 18 sections
Carafate HUMAN PRESCRIPTION DRUG LABEL 1 17856-0170 SUSPENSION 1 g ORAL NDA 19 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 17856-1011 SUSPENSION 1 g ORAL NDA AUTHORIZED GENERIC 19 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 29033-003 TABLET 1 g ORAL ANDA 18 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 42291-757 TABLET 1 g ORAL ANDA 20 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 42291-781 SUSPENSION 1 g ORAL ANDA 18 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 43353-061 TABLET 1 g ORAL NDA 18 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 50090-0582 TABLET 1 g ORAL ANDA 20 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 50090-3019 TABLET 1 g ORAL ANDA 20 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 50090-5287 TABLET 1 g ORAL NDA AUTHORIZED GENERIC 18 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 50268-732 SUSPENSION 1 g ORAL ANDA 18 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 51079-753 TABLET 1 g ORAL ANDA 20 sections
SUCRALFATE HUMAN PRESCRIPTION DRUG LABEL 1 51655-031 TABLET 1 g ORAL ANDA 9 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 53002-4930 TABLET 1 g ORAL ANDA 20 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 53808-0593 TABLET 1 g ORAL NDA 18 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 53808-0797 TABLET 1 g ORAL ANDA 18 sections
Carafate HUMAN PRESCRIPTION DRUG LABEL 1 54868-3735 SUSPENSION 1 g ORAL NDA 19 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 54868-3933 TABLET 1 g ORAL ANDA 11 sections
SUCRALFATE HUMAN PRESCRIPTION DRUG LABEL 1 54868-5299 SUSPENSION 1 g ORAL NDA 19 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 55154-4379 TABLET 1 g ORAL ANDA 20 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 55154-5778 SUSPENSION 1 g ORAL NDA 20 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 55154-8133 TABLET 1 g ORAL ANDA 20 sections
Carafate HUMAN PRESCRIPTION DRUG LABEL 1 58914-170 SUSPENSION 1 g ORAL NDA 19 sections
Carafate HUMAN PRESCRIPTION DRUG LABEL 1 58914-171 TABLET 1 g ORAL NDA 19 sections
Sucralfate HUMAN PRESCRIPTION DRUG LABEL 1 59762-0401 TABLET 1 g ORAL NDA AUTHORIZED GENERIC 18 sections