clavulanic acid ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
beta-lactamase inhibitors 669 58001-44-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • clavulanic acid
  • clavulanate
  • clavulanate potassium
  • clavulante potasium
  • clavulanate potassium salt
A beta-lactam antibiotic produced by the actinobacterium Streptomyces clavuligerus. It is a suicide inhibitor of bacterial beta-lactamase enzymes. Administered alone, it has only weak antibacterial activity against most organisms, but given in combination with other beta-lactam antibiotics it prevents antibiotic inactivation by microbial lactamase.
  • Molecular weight: 199.16
  • Formula: C8H9NO5
  • CLOGP: -1.06
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 87.07
  • ALOGS: 0.23
  • ROTB: 2
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 43 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 31.38 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 75 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.22 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.10 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.91 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.90 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Aug. 6, 1984 FDA DR REDDYS 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
Acute generalised exanthematous pustulosis 99.74 15.40 43 10659 13660 90604085
Toxic skin eruption 87.69 15.40 41 10661 15733 90602012
Hepatitis cholestatic 86.59 15.40 34 10668 8527 90609218
Cholestasis 84.68 15.40 53 10649 36246 90581499
Bronchiectasis 74.21 15.40 41 10661 22289 90595456
Drug reaction with eosinophilia and systemic symptoms 67.50 15.40 49 10653 42709 90575036
Jaundice 62.38 15.40 42 10660 32475 90585270
Anaphylactic reaction 61.34 15.40 63 10639 87461 90530284
Mixed liver injury 59.03 15.40 25 10677 7598 90610147
Drug hypersensitivity 55.35 15.40 149 10553 463460 90154285
Toxic epidermal necrolysis 50.70 15.40 37 10665 32491 90585254
Hypothyroidism 50.01 15.40 45 10657 53082 90564663
Cholecystitis chronic 49.89 15.40 24 10678 9802 90607943
Rash scarlatiniform 49.84 15.40 10 10692 204 90617541
Neutropenia 49.07 15.40 92 10610 224812 90392933
Bone erosion 46.18 15.40 43 10659 52978 90564767
Nail dystrophy 44.69 15.40 13 10689 1305 90616440
Acute kidney injury 44.41 15.40 109 10593 320278 90297467
International normalised ratio increased 44.38 15.40 40 10662 47276 90570469
Rash maculo-papular 43.19 15.40 37 10665 40896 90576849
Anaphylactic shock 40.52 15.40 32 10670 31585 90586160
Hepatic cytolysis 39.00 15.40 31 10671 30885 90586860
Hepatocellular injury 38.60 15.40 30 10672 28928 90588817
Axillary pain 37.45 15.40 13 10689 2308 90615437
Pruritus 35.52 15.40 142 10560 541383 90076362
Catheter site haemorrhage 35.10 15.40 14 10688 3654 90614091
Clostridium difficile colitis 34.16 15.40 27 10675 26679 90591066
Eosinophilia 32.59 15.40 27 10675 28506 90589239
Emotional distress 32.43 15.40 30 10672 36632 90581113
Appendicitis 31.84 15.40 18 10684 10213 90607532
Bone marrow eosinophilic leukocyte count increased 30.94 15.40 5 10697 27 90617718
Purpura 30.54 15.40 20 10682 14758 90602987
Cholelithiasis 30.10 15.40 34 10668 52472 90565273
Gamma-glutamyltransferase increased 29.66 15.40 29 10673 37923 90579822
Allergic hepatitis 29.59 15.40 5 10697 37 90617708
Dermatitis exfoliative 29.56 15.40 14 10688 5522 90612223
Hydronephrosis 28.64 15.40 18 10684 12384 90605361
Odynophagia 28.39 15.40 16 10686 9027 90608718
Pemphigus 27.99 15.40 3 10699 326861 90290884
Arthropathy 27.53 15.40 5 10697 366237 90251508
Aspartate aminotransferase increased 27.43 15.40 46 10656 102891 90514854
Blood alkaline phosphatase increased 27.33 15.40 31 10671 48048 90569697
Contraindicated product administered 27.26 15.40 3 10699 320136 90297609
Bronchospasm 26.62 15.40 21 10681 20688 90597057
Alanine aminotransferase increased 26.51 15.40 49 10653 118289 90499456
Peripheral swelling 26.40 15.40 8 10694 413098 90204647
Abdominal discomfort 25.90 15.40 12 10690 477316 90140429
Deep vein thrombosis 25.83 15.40 42 10660 91578 90526167
Glossodynia 25.05 15.40 4 10698 321775 90295970
Hyperchlorhydria 24.27 15.40 9 10693 1932 90615813
Prothrombin level decreased 24.22 15.40 7 10695 687 90617058
Stevens-Johnson syndrome 24.00 15.40 23 10679 29353 90588392
Folate deficiency 23.25 15.40 10 10692 3155 90614590
Hyperleukocytosis 22.52 15.40 7 10695 880 90616865
Agranulocytosis 22.37 15.40 24 10678 34978 90582767
Abdominal pain 22.18 15.40 99 10603 395622 90222123
Cytomegalovirus infection 22.05 15.40 21 10681 26581 90591164
Alopecia 21.81 15.40 16 10686 495055 90122690
Drug interaction 21.81 15.40 77 10625 276376 90341369
Joint swelling 21.24 15.40 17 10685 503283 90114462
Wound 20.98 15.40 5 10697 302975 90314770
Nasopharyngitis 20.92 15.40 11 10691 407093 90210652
Pulmonary embolism 20.79 15.40 47 10655 130773 90486972
Ejection fraction decreased 20.40 15.40 20 10682 26233 90591512
Hypokalaemia 19.62 15.40 46 10656 131070 90486675
Chromaturia 19.54 15.40 17 10685 19170 90598575
Linear IgA disease 19.43 15.40 8 10694 2266 90615479
Thrombocytopenia 18.99 15.40 61 10641 208664 90409081
Product use in unapproved indication 18.94 15.40 8 10694 336228 90281517
Constipation 18.70 15.40 74 10628 280321 90337424
Meningitis aseptic 18.64 15.40 11 10691 6762 90610983
Panic attack 18.49 15.40 19 10683 26346 90591399
Hepatitis acute 18.37 15.40 13 10689 10874 90606871
Pseudomembranous colitis 18.29 15.40 9 10693 3859 90613886
Red blood cell sedimentation rate abnormal 17.99 15.40 18 10684 24186 90593559
Exposed bone in jaw 17.49 15.40 8 10694 2918 90614827
Anaemia 17.36 15.40 85 10617 352717 90265028
Febrile bone marrow aplasia 17.30 15.40 12 10690 9726 90608019
Neuropathy peripheral 17.26 15.40 45 10657 136925 90480820
Strawberry tongue 17.23 15.40 3 10699 27 90617718
Maternal exposure during pregnancy 16.69 15.40 11 10691 360052 90257693
Chondroma 16.68 15.40 3 10699 33 90617712
Blood bilirubin increased 16.64 15.40 23 10679 43447 90574298
Swelling 16.64 15.40 15 10687 419043 90198702
Veillonella infection 16.52 15.40 3 10699 35 90617710
Loss of personal independence in daily activities 16.42 15.40 44 10658 136061 90481684
Dementia 16.38 15.40 17 10685 23844 90593901
Off label use 16.29 15.40 71 10631 1102181 89515564
Pyroglutamic acidosis 16.24 15.40 6 10696 1274 90616471
Osteolysis 16.01 15.40 8 10694 3542 90614203
Sepsis 15.85 15.40 52 10650 179762 90437983
Eosinophilic myocarditis 15.70 15.40 5 10697 680 90617065
Erythema 15.68 15.40 61 10641 229185 90388560
Dialysis 15.67 15.40 12 10690 11317 90606428
Blood creatinine increased 15.63 15.40 36 10666 101350 90516395

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
Hepatocellular injury 144.39 16.41 77 8260 23601 42589397
Cholestasis 136.07 16.41 83 8254 32796 42580202
Jaundice 89.03 16.41 65 8272 34524 42578474
Hepatitis cholestatic 83.44 16.41 40 8297 9784 42603214
Spinal muscular atrophy 68.60 16.41 16 8321 400 42612598
Motor neurone disease 63.90 16.41 16 8321 543 42612455
Hepatic cytolysis 61.37 16.41 47 8290 26797 42586201
Stoma closure 56.94 16.41 13 8324 295 42612703
Anaphylactic shock 55.57 16.41 42 8295 23475 42589523
Pneumococcal sepsis 52.83 16.41 17 8320 1438 42611560
Purpura 51.69 16.41 31 8306 11848 42601150
Ischaemic cerebral infarction 50.80 16.41 17 8320 1626 42611372
Lymphadenectomy 50.62 16.41 13 8324 489 42612509
Bronchial disorder 49.40 16.41 16 8321 1382 42611616
Lower respiratory tract infection bacterial 49.12 16.41 13 8324 551 42612447
Urethral valves 48.16 16.41 11 8326 250 42612748
Increased bronchial secretion 41.30 16.41 16 8321 2330 42610668
Rash maculo-papular 40.46 16.41 43 8294 37460 42575538
Drug reaction with eosinophilia and systemic symptoms 39.76 16.41 45 8292 42030 42570968
Anaphylactic reaction 39.18 16.41 45 8292 42698 42570300
Toxic epidermal necrolysis 38.72 16.41 36 8301 26714 42586284
Disease complication 37.14 16.41 16 8321 3054 42609944
Scoliosis 36.86 16.41 16 8321 3110 42609888
Sputum increased 36.68 16.41 16 8321 3147 42609851
Off label use 36.43 16.41 43 8294 638292 41974706
Hepatitis 36.20 16.41 35 8302 27265 42585733
Toxic skin eruption 35.74 16.41 26 8311 13704 42599294
Demyelination 35.00 16.41 16 8321 3513 42609485
Jaundice cholestatic 34.58 16.41 18 8319 5235 42607763
Resuscitation 34.10 16.41 13 8324 1812 42611186
Respiratory tract infection bacterial 33.53 16.41 13 8324 1896 42611102
Chest X-ray abnormal 31.27 16.41 16 8321 4492 42608506
Stevens-Johnson syndrome 30.47 16.41 29 8308 22149 42590849
Metabolic disorder 30.36 16.41 16 8321 4772 42608226
Motor dysfunction 29.70 16.41 19 8318 8127 42604871
Eosinophilia 29.08 16.41 34 8303 32865 42580133
Circulatory collapse 28.91 16.41 29 8308 23607 42589391
Blood alkaline phosphatase increased 28.50 16.41 34 8303 33563 42579435
Blood bilirubin increased 28.29 16.41 38 8299 42214 42570784
Brain injury 28.27 16.41 18 8319 7637 42605361
Drug ineffective 27.58 16.41 51 8286 630146 41982852
Cerebral ischaemia 27.30 16.41 17 8320 6942 42606056
Inflammation 26.67 16.41 33 8304 33814 42579184
Chromaturia 26.04 16.41 23 8314 15966 42597032
Lung consolidation 25.41 16.41 16 8321 6661 42606337
Intestinal ischaemia 24.94 16.41 18 8319 9370 42603628
Mechanical ventilation 24.73 16.41 11 8326 2266 42610732
Lung infiltration 24.55 16.41 21 8316 13968 42599030
Muscle atrophy 24.45 16.41 17 8320 8344 42604654
Pruritus 23.78 16.41 86 8251 188685 42424313
Liver function test abnormal 23.02 16.41 30 8307 32361 42580637
Dermatitis exfoliative 22.39 16.41 15 8322 6932 42606066
Atelectasis 22.30 16.41 23 8314 19338 42593660
Endotracheal intubation 22.17 16.41 12 8325 3773 42609225
Kounis syndrome 20.63 16.41 11 8326 3357 42609641
Alanine aminotransferase increased 20.44 16.41 50 8287 88356 42524642
Mixed liver injury 20.30 16.41 12 8325 4462 42608536
Meningitis aseptic 20.28 16.41 12 8325 4470 42608528
Pyrexia 20.27 16.41 139 8198 393903 42219095
Bronchospasm 19.92 16.41 18 8319 12867 42600131
Gamma-glutamyltransferase increased 19.90 16.41 28 8309 32469 42580529
Injury 19.61 16.41 23 8314 22293 42590705
Aspartate aminotransferase increased 19.31 16.41 45 8292 77118 42535880
Death 18.94 16.41 40 8297 471145 42141853
Vascular purpura 18.85 16.41 9 8328 2177 42610821
Secretion discharge 18.83 16.41 14 8323 7621 42605377
Atrophic glossitis 18.46 16.41 3 8334 9 42612989
Toxicity to various agents 18.44 16.41 11 8326 229125 42383873
Product dose omission issue 18.15 16.41 4 8333 154361 42458637
Aminoaciduria 17.92 16.41 5 8332 259 42612739
Erythema 17.63 16.41 54 8283 108739 42504259
Urticaria 17.25 16.41 42 8295 73994 42539004
Face oedema 17.14 16.41 17 8320 13649 42599349
Tachypnoea 16.87 16.41 21 8316 21641 42591357

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
Cholestasis 220.22 14.41 130 16132 64388 110508649
Hepatocellular injury 180.59 14.41 105 16157 50537 110522500
Hepatitis cholestatic 150.59 14.41 66 16196 17500 110555537
Jaundice 143.33 14.41 96 16166 59140 110513897
Toxic skin eruption 105.94 14.41 60 16202 27455 110545582
Toxic epidermal necrolysis 89.50 14.41 71 16191 56656 110516381
Hepatic cytolysis 89.22 14.41 70 16192 54983 110518054
Anaphylactic reaction 88.28 14.41 96 16166 114204 110458833
Drug reaction with eosinophilia and systemic symptoms 87.32 14.41 82 16180 82013 110491024
Anaphylactic shock 84.52 14.41 66 16196 51480 110521557
Acute generalised exanthematous pustulosis 82.75 14.41 47 16215 21617 110551420
Purpura 75.01 14.41 46 16216 24342 110548695
Spinal muscular atrophy 72.72 14.41 16 16246 411 110572626
Mixed liver injury 71.14 14.41 35 16227 12044 110560993
Rash maculo-papular 65.59 14.41 67 16195 74155 110498882
Motor neurone disease 64.32 14.41 16 16246 708 110572329
Stoma closure 56.58 14.41 13 16249 408 110572629
Blood alkaline phosphatase increased 55.48 14.41 60 16202 70875 110502162
Rash scarlatiniform 52.88 14.41 12 16250 356 110572681
Eosinophilia 50.64 14.41 52 16210 57884 110515153
Pneumococcal sepsis 50.59 14.41 17 16245 2195 110570842
Chromaturia 49 14.41 38 16224 29322 110543715
Gamma-glutamyltransferase increased 48.19 14.41 52 16210 61257 110511780
Aspartate aminotransferase increased 47.85 14.41 85 16177 159851 110413186
Clostridium difficile colitis 47.05 14.41 44 16218 43734 110529303
Alanine aminotransferase increased 46.64 14.41 91 16171 183682 110389355
Jaundice cholestatic 46.06 14.41 28 16234 14580 110558457
Lower respiratory tract infection bacterial 44.37 14.41 13 16249 1072 110571965
Infusion related reaction 44.35 14.41 3 16259 381159 110191878
Lymphadenectomy 44.01 14.41 14 16248 1522 110571515
Bronchial disorder 43.11 14.41 16 16246 2760 110570277
Pruritus 42.80 14.41 184 16078 581376 109991661
Nail dystrophy 42.78 14.41 13 16249 1215 110571822
Stevens-Johnson syndrome 42.63 14.41 43 16219 46858 110526179
Ischaemic cerebral infarction 42.19 14.41 16 16246 2929 110570108
Dermatitis exfoliative 41.67 14.41 24 16238 11323 110561714
Respiratory tract infection bacterial 41.51 14.41 15 16247 2401 110570636
Sputum increased 40.99 14.41 19 16243 5732 110567305
International normalised ratio increased 39.65 14.41 56 16206 86716 110486321
Increased bronchial secretion 37.65 14.41 16 16246 3932 110569105
Peripheral swelling 37.53 14.41 7 16255 404027 110169010
Meningitis aseptic 36.58 14.41 21 16241 9849 110563188
Blood bilirubin increased 36.15 14.41 50 16212 75922 110497115
Bronchospasm 35.63 14.41 32 16230 30207 110542830
Off label use 34.44 14.41 110 16152 1500075 109072962
Nasopharyngitis 34.22 14.41 8 16254 394353 110178684
Axillary pain 33.30 14.41 13 16249 2573 110570464
Drug hypersensitivity 32.85 14.41 143 16119 453947 110119090
Rash morbilliform 32.39 14.41 18 16244 7933 110565104
Acute kidney injury 32.35 14.41 181 16081 635249 109937788
Pyrexia 32.22 14.41 234 16028 898031 109675006
Resuscitation 31.71 14.41 13 16249 2920 110570117
Disease complication 31.70 14.41 16 16246 5811 110567226
Kounis syndrome 31.45 14.41 16 16246 5909 110567128
Hepatitis 29.71 14.41 50 16212 90004 110483033
Bone marrow eosinophilic leukocyte count increased 29.69 14.41 5 16257 28 110573009
Demyelination 29.54 14.41 18 16244 9411 110563626
Drug ineffective 29.25 14.41 120 16142 1520420 109052617
Chest X-ray abnormal 28.65 14.41 17 16245 8470 110564567
Neutropenia 28.65 14.41 120 16142 374500 110198537
Brain injury 28.23 14.41 20 16242 13456 110559581
Lung consolidation 27.80 14.41 18 16244 10458 110562579
Metabolic disorder 27.74 14.41 18 16244 10492 110562545
Allergic hepatitis 27.24 14.41 5 16257 49 110572988
Cholecystitis chronic 26.89 14.41 17 16245 9483 110563554
Thrombocytopenia 26.86 14.41 112 16150 348773 110224264
Arthropathy 26.65 14.41 5 16257 287517 110285520
Hepatitis acute 26.44 14.41 22 16240 18744 110554293
Circulatory collapse 26.24 14.41 32 16230 42961 110530076
Catheter site haemorrhage 25.85 14.41 14 16248 5866 110567171
Scoliosis 25.65 14.41 16 16246 8717 110564320
Face oedema 25.62 14.41 28 16234 33441 110539596
Cerebral ischaemia 25.44 14.41 18 16244 12086 110560951
Atelectasis 25.17 14.41 29 16233 36683 110536354
Intestinal ischaemia 24.97 14.41 20 16242 16159 110556878
Abdominal discomfort 24.10 14.41 14 16248 393844 110179193
Muscle atrophy 23.97 14.41 18 16244 13236 110559801
Mechanical ventilation 23.80 14.41 11 16251 3296 110569741
Contraindicated product administered 23.70 14.41 4 16258 248263 110324774
Tachypnoea 23.52 14.41 29 16233 39366 110533671
Strawberry tongue 23.24 14.41 4 16258 26 110573011
Lung infiltration 23.15 14.41 23 16239 24605 110548432
Joint swelling 22.78 14.41 19 16243 442826 110130211
Vascular purpura 22.42 14.41 11 16251 3760 110569277
Mobility decreased 22.28 14.41 4 16258 237418 110335619
Bronchiectasis 22.01 14.41 27 16235 36466 110536571
Pemphigus 21.52 14.41 3 16259 214567 110358470
Treatment failure 21.47 14.41 7 16255 277227 110295810
Hydronephrosis 20.73 14.41 20 16242 20645 110552392
Faeces pale 20.58 14.41 10 16252 3347 110569690
Emotional distress 20.56 14.41 29 16233 44818 110528219
Maternal exposure during pregnancy 20.52 14.41 6 16256 254877 110318160
Therapeutic product effect incomplete 20.51 14.41 4 16258 223801 110349236
Weight increased 20.38 14.41 19 16243 419625 110153412
Cholestatic liver injury 20.38 14.41 13 16249 7363 110565674
Glossodynia 20.27 14.41 4 16258 222000 110351037
Dehydration 20.16 14.41 88 16174 279423 110293614
Agranulocytosis 19.98 14.41 34 16228 61726 110511311
Endotracheal intubation 19.94 14.41 12 16250 6132 110566905
Death 19.89 14.41 46 16216 698823 109874214
Wound 19.85 14.41 5 16257 234432 110338605
Deep vein thrombosis 19.70 14.41 55 16207 139832 110433205
Intentional product use issue 19.66 14.41 6 16256 247900 110325137
Febrile bone marrow aplasia 19.63 14.41 18 16244 17447 110555590
Pseudomembranous colitis 19.51 14.41 12 16250 6379 110566658
Type I hypersensitivity 19.50 14.41 12 16250 6381 110566656
Cholelithiasis 19.33 14.41 34 16228 63388 110509649
Headache 19.26 14.41 66 16196 882311 109690726
Therapeutic product effect decreased 19.22 14.41 6 16256 244310 110328727
Product dose omission issue 18.89 14.41 12 16250 321770 110251267
Odynophagia 18.77 14.41 16 16246 14085 110558952
Cholangitis 18.68 14.41 17 16245 16318 110556719
Renal failure 18.42 14.41 74 16188 226500 110346537
Erythema 18.23 14.41 88 16174 291359 110281678
Hyperchlorhydria 18.10 14.41 8 16254 2161 110570876
Drug interaction 17.69 14.41 130 16132 500053 110072984
Product use in unapproved indication 17.64 14.41 24 16238 447353 110125684
Aminoaciduria 17.58 14.41 5 16257 371 110572666
Pulmonary hilum mass 17.32 14.41 5 16257 391 110572646
Hypothyroidism 17.15 14.41 35 16227 72864 110500173
Transaminases increased 16.81 14.41 32 16230 63358 110509679
Rash 16.59 14.41 189 16073 820775 109752262
Liver function test abnormal 16.10 14.41 33 16229 68917 110504120
Alopecia 16.02 14.41 18 16244 364735 110208302
Hyperbilirubinaemia 15.82 14.41 21 16241 30650 110542387
Lower respiratory tract infection 15.80 14.41 8 16254 243098 110329939
Bone erosion 15.63 14.41 26 16236 46345 110526692
Appendicitis 15.48 14.41 20 16242 28444 110544593
Diarrhoea 15.44 14.41 244 16018 1139261 109433776
Atrophic glossitis 15.42 14.41 3 16259 41 110572996
Linear IgA disease 15.36 14.41 9 16253 4380 110568657
Folate deficiency 15.27 14.41 9 16253 4429 110568608
Rheumatoid arthritis 15.22 14.41 13 16249 299600 110273437
Infective exacerbation of chronic obstructive airways disease 15.16 14.41 8 16254 3182 110569855
Veillonella infection 14.98 14.41 3 16259 48 110572989
Hypertension 14.97 14.41 33 16229 510051 110062986
Respiratory distress 14.96 14.41 32 16230 68842 110504195
Hyperthermia 14.91 14.41 17 16245 21255 110551782
Blood pressure increased 14.67 14.41 10 16252 258363 110314674
Injection site pain 14.67 14.41 4 16258 177918 110395119
Motor dysfunction 14.62 14.41 18 16244 24388 110548649
Injury 14.49 14.41 58 16204 177207 110395830

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
FDA MoA N0000000202 beta Lactamase Inhibitors
FDA EPC N0000175930 beta Lactamase Inhibitor
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D065093 beta-Lactamase Inhibitors
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:33231 antitubercular agent
CHEBI has role CHEBI:33281 antimicrobial agent
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35620 vasodilator agent
CHEBI has role CHEBI:35625 EC 3.5.2.6 (ฮฒ-lactamase) inhibitor
CHEBI has role CHEBI:36047 antibacterial drug
CHEBI has role CHEBI:49201 anti-ulcer drug
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:74518 anti-obesity agent
CHEBI has role CHEBI:76969 bacterial metabolite

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

DiseaseRelationSNOMED_IDDOID
Septicemia due to Escherichia coli indication 9323009
Bacterial septicemia indication 10001005 DOID:0040085
Haemophilus Influenzae Acute Otitis Media indication 19021002
Infection of skin AND/OR subcutaneous tissue indication 19824006
Staphylococcal pneumonia indication 22754005
Bacterial pneumonia indication 53084003 DOID:874
Klebsiella cystitis indication 60867007
Pneumonia due to Klebsiella pneumoniae indication 64479007
Urinary tract infectious disease indication 68566005
Haemophilus influenzae pneumonia indication 70036007
Infection due to Escherichia coli indication 71057007
Rhinoscleroma indication 72409005 DOID:11336
Acute bacterial sinusitis indication 75498004
Bacterial infection due to Klebsiella pneumoniae indication 186435004
Pneumococcal pneumonia indication 233607000
Escherichia coli urinary tract infection indication 301011002
Bacterial urinary infection indication 312124009
Infective otitis media indication 312218008
Infection due to Staphylococcus aureus indication 406602003
Osteomyelitis due to Staphylococcus aureus indication 428783003
Pneumonia due to Staphylococcus aureus indication 441658007
Sepsis due to Staphylococcus aureus indication 448417001
Sepsis due to Pseudomonas indication 448813005
Moraxella Catarrhalis Acute Otitis Media indication 703469002
Bacteroides Endometritis indication
Pneumococcal Acute Otitis Media indication
Haemophilus Parainfluenzae Pneumonia indication
Pseudomonas Aeruginosa Urinary Tract Infection indication
Klebsiella Endometritis indication
Klebsiella Pneumoniae Peritonitis indication
Moraxella Catarrhalis Pneumonia indication
Staphylococcus Aureus Joint Infection indication
Staphylococcus Aureus Urinary Tract Infection indication
E. Coli Peritonitis indication
Enterobacter Endometritis indication
Bacteroides Peritonitis indication
Serratia Urinary Tract Infection indication
Citrobacter Urinary Tract Infection indication
Staphylococcus Endometritis indication
E. Coli Endometritis indication
Acute otitis media off-label use 3110003
Pyrexia of unknown origin off-label use 7520000
Chronic purulent otitis media off-label use 38394007 DOID:14247
Cholangitis off-label use 82403002 DOID:9446
Human bite - wound off-label use 262555007
Chancroid off-label use 266143009 DOID:13778
Diverticulitis of gastrointestinal tract off-label use 271366000
Dog bite - wound off-label use 283734005
Cat bite - wound off-label use 283782004
Acute exacerbation of chronic bronchitis off-label use 425748003
Diabetic Foot Infection off-label use
Pseudomonas Respiratory Tract Infection in Cystic Fibrosis off-label use
Obstruction of bile duct contraindication 30144000
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409
Infectious mononucleosis contraindication 271558008 DOID:8568
Pseudomembranous enterocolitis contraindication 397683000




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Dogs Urinary tract infections caused by Escherichia coli Indication
Dogs Skin and soft tissue infections caused by beta-lactamase producing Staphylococcus aureus Indication
Dogs Skin and soft tissue infections caused by Staphylococcus spp Indication
Dogs Skin and soft tissue infections caused by Streptococcus spp Indication
Dogs Skin and soft tissue infections caused by Escherichia coli Indication
Dogs Skin and soft tissue infections caused by Pasteurella spp Indication
Cats Urinary tract infections caused by Escherichia coli Indication
Cats Skin and soft tissue infections caused by beta-lactamase producing Staphylococcus aureus Indication
Cats Skin and soft tissue infections caused by Staphylococcus spp Indication
Cats Skin and soft tissue infections caused by Streptococcus spp Indication
Cats Skin and soft tissue infections caused by Escherichia coli Indication
Cats Skin and soft tissue infections caused by Pasteurella spp Indication
Cats Periodontal infections due aerobic and anaerobic bacteria Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
CLAVAMOX CHEWABLE Tablets, CLAVAMOX tablets Zoetis Inc. 2
Clavamox Drops Zoetis Inc. 2
Clavacillin Dechra Veterinary Products LLC 2
Amoxicillin and Clavulanate Potassium for Oral Suspension Dechra Veterinary Products LLC 2
Amoxicillin and Clavulanate Potassium Tablets Cronus Pharma Specialities India Private Limited 2
Amoxicillin and Clavulanate Potassium for Oral Suspension Cronus Pharma Specialities India Private Limited 2

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.07 acidic
pKa2 13.53 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Beta-lactamase TEM Enzyme INHIBITOR IC50 10.19 WOMBAT-PK CHEMBL
Beta-lactamase Enzyme IC50 7.82 CHEMBL
Beta-lactamase Enzyme IC50 4 CHEMBL
Beta-lactamase SHV-1 Enzyme IC50 7.55 CHEMBL
Beta-lactamase Enzyme Kd 6.40 CHEMBL
Beta-lactamase OXA-1 Enzyme IC50 5.49 CHEMBL
Beta-lactamase Enzyme IC50 6.10 CHEMBL
Beta-lactamase Enzyme IC50 8.05 CHEMBL
Beta-lactamase Enzyme IC50 7.15 CHEMBL
Beta-lactamase Enzyme IC50 7.07 CHEMBL
Carbapenem-hydrolizing beta-lactamase SFC-1 Enzyme IC50 4.14 CHEMBL
Carbepenem-hydrolyzing beta-lactamase KPC Enzyme Ki 4.96 CHEMBL
Beta-lactamase Enzyme IC50 7.17 CHEMBL
Beta-lactamase Enzyme IC50 8.05 CHEMBL
Beta-lactamase SHV-1 Enzyme IC50 6.77 CHEMBL
Beta-lactamase Enzyme IC50 5.07 CHEMBL
Beta-lactamase GES-13 Enzyme IC50 7 CHEMBL
Beta-lactamase Enzyme IC50 5.76 CHEMBL
Beta-lactamase Enzyme IC50 7.70 CHEMBL
Class D beta-lactamase Enzyme IC50 5.70 CHEMBL
Beta-lactamase Enzyme IC50 8 CHEMBL
Beta-lactamase SHV-5 Enzyme Ki 4.60 CHEMBL
Beta-lactamase Enzyme IC50 7 CHEMBL
Beta-lactamase Enzyme IC50 7 CHEMBL
Beta-lactamase Enzyme MPC 8.72 WOMBAT-PK
Beta-lactamase Enzyme IC50 7.44 CHEMBL

External reference:

IDSource
N0000005804 NUI
D02370 KEGG_DRUG
61177-45-5 SECONDARY_CAS_RN
21216 RXNORM
C0055860 UMLSCUI
CHEBI:48947 CHEBI
J01 PDB_CHEM_ID
CHEMBL777 ChEMBL_ID
DB00766 DRUGBANK_ID
CHEMBL1003 ChEMBL_ID
D019818 MESH_DESCRIPTOR_UI
5280980 PUBCHEM_CID
11128 IUPHAR_LIGAND_ID
4948 INN_ID
23521W1S24 UNII
4463 MMSL
d04405 MMSL
002808 NDDF
002809 NDDF
395938000 SNOMEDCT_US
395939008 SNOMEDCT_US
412318009 SNOMEDCT_US
4018406 VANDF
4019680 VANDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2274 TABLET, FILM COATED 125 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2274 TABLET, FILM COATED 125 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2275 TABLET, FILM COATED 125 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2275 TABLET, FILM COATED 125 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2277 POWDER, FOR SUSPENSION 28.50 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2277 POWDER, FOR SUSPENSION 28.50 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2279 POWDER, FOR SUSPENSION 57 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2279 POWDER, FOR SUSPENSION 57 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-8675 POWDER, FOR SUSPENSION 42.90 mg ORAL ANDA 26 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0143-9249 TABLET 125 mg ORAL ANDA 28 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0143-9249 TABLET 125 mg ORAL ANDA 28 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0143-9853 SUSPENSION 42.90 mg ORAL ANDA 25 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0143-9981 POWDER, FOR SUSPENSION 28.50 mg ORAL ANDA 28 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0143-9982 POWDER, FOR SUSPENSION 57 mg ORAL ANDA 28 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0781-1831 TABLET, FILM COATED 125 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0781-1852 TABLET, FILM COATED 125 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0781-1874 TABLET, FILM COATED 125 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 3 0781-1943 TABLET, MULTILAYER, EXTENDED RELEASE 62.50 mg ORAL ANDA 25 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0781-6102 POWDER, FOR SUSPENSION 28.50 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0781-6104 POWDER, FOR SUSPENSION 57 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0781-6139 SUSPENSION 42.90 mg ORAL ANDA 25 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 10544-931 TABLET, FILM COATED 125 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 10544-951 TABLET, FILM COATED 125 mg ORAL ANDA 26 sections
AMOXICILLIN AND CLAVULANATE POTASSIUM HUMAN PRESCRIPTION DRUG LABEL 2 16590-019 TABLET, FILM COATED 125 mg ORAL ANDA 26 sections
AMOXICILLIN AND CLAVULANATE POTASSIUM HUMAN PRESCRIPTION DRUG LABEL 2 16590-020 TABLET, FILM COATED 125 mg ORAL ANDA 15 sections
Amoxicillin and Clavulanate Potassium Human Prescription Drug Label 2 16714-292 POWDER, FOR SUSPENSION 28.50 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium Human Prescription Drug Label 2 16714-293 POWDER, FOR SUSPENSION 57 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium Human Prescription Drug Label 2 16714-294 POWDER, FOR SUSPENSION 42.90 mg ORAL ANDA 25 sections
Amoxicillin and Clavulanate Potassium Human Prescription Drug Label 2 16714-295 TABLET, FILM COATED 125 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium Human Prescription Drug Label 2 16714-296 TABLET, FILM COATED 125 mg ORAL ANDA 27 sections