famotidine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
histamine-H2-receptor antagonists, cimetidine derivatives 1129 76824-35-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • famotidine
  • agufam
  • amfamox
  • antodine
  • apogastine
  • bestidine
  • brolin
  • cepal
  • digervin
  • dispromil
A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion. Computer-aided, structure-based, virtual screening of libraries of compounds against SARS-CoV-2 proteins suggested potential for famotidine to interact with viral proteases in-volved in coronavirus replication. HOWEVER, there is no clinical trial evidence supporting efficacy or safety for treatment of COVID-19.
  • Molecular weight: 337.44
  • Formula: C8H15N7O2S3
  • CLOGP: -0.86
  • LIPINSKI: 1
  • HAC: 9
  • HDO: 6
  • TPSA: 170.83
  • ALOGS: -3.48
  • ROTB: 6

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
40 mg O
40 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 67 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.98 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 42 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 6.60 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.84 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.80 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Oct. 15, 1986 FDA VALEANT PHARMS NORTH

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 368.70 9.42 764 114797 816481 52417024
Rheumatoid arthritis 314.76 9.42 144 115417 314387 52919118
Contraindicated product administered 237.52 9.42 14 115547 135615 53097890
Synovitis 209.71 9.42 5 115556 107888 53125617
Drug intolerance 200.86 9.42 97 115464 205396 53028109
Joint swelling 158.14 9.42 165 115396 234473 52999032
Hand deformity 147.78 9.42 9 115552 84840 53148665
Treatment failure 146.04 9.42 48 115513 128355 53105150
Systemic lupus erythematosus 138.95 9.42 49 115512 125365 53108140
Glossodynia 134.10 9.42 27 115534 100264 53133241
Therapeutic product effect decreased 127.84 9.42 56 115505 125599 53107906
Arthropathy 126.08 9.42 75 115486 141378 53092127
Hepatic function abnormal 122.06 9.42 256 115305 36643 53196862
Gastrooesophageal reflux disease 119.95 9.42 423 115138 82240 53151265
Pneumonia aspiration 114.65 9.42 239 115322 34062 53199443
Chronic kidney disease 104.92 9.42 266 115295 43104 53190401
Platelet count decreased 104.05 9.42 487 115074 107612 53125893
White blood cell count decreased 103.60 9.42 538 115023 123937 53109568
Maternal exposure during pregnancy 87.32 9.42 126 115435 155513 53077992
Lower respiratory tract infection 85.72 9.42 45 115516 90936 53142569
Wound 85.21 9.42 46 115515 91511 53141994
Pericarditis 84.72 9.42 18 115543 64388 53169117
Drug abuse 78.98 9.42 22 115539 65504 53168001
Toxicity to various agents 75.93 9.42 234 115327 219364 53014141
Alopecia 73.52 9.42 261 115300 234322 52999183
Disseminated intravascular coagulation 65.42 9.42 137 115424 19582 53213923
Hepatic enzyme increased 62.43 9.42 111 115450 126084 53107421
Off label use 61.72 9.42 690 114871 471522 52761983
General physical health deterioration 60.21 9.42 144 115417 146798 53086707
Helicobacter infection 60.21 9.42 7 115554 39062 53194443
Aspartate aminotransferase increased 59.03 9.42 347 115214 83682 53149823
Duodenal ulcer perforation 57.61 9.42 5 115556 35178 53198327
Neutrophil count decreased 56.95 9.42 234 115327 48864 53184641
Product use issue 55.45 9.42 139 115422 139445 53094060
Arthralgia 54.56 9.42 650 114911 439133 52794372
Cholecystitis chronic 53.72 9.42 88 115473 10430 53223075
Musculoskeletal stiffness 52.87 9.42 118 115443 123250 53110255
Flushing 50.52 9.42 293 115268 70307 53163198
Discomfort 49.02 9.42 82 115479 95390 53138115
Blood lactate dehydrogenase increased 48.97 9.42 130 115431 21651 53211854
Liver disorder 48.65 9.42 194 115367 39961 53193544
Swelling 48.35 9.42 231 115330 190874 53042631
Folliculitis 48.08 9.42 6 115555 31703 53201802
Dehydration 46.71 9.42 564 114997 167846 53065659
Butterfly rash 45.69 9.42 29 115532 1078 53232427
Drug hypersensitivity 45.52 9.42 362 115199 264880 52968625
Alanine aminotransferase increased 45.41 9.42 357 115204 94738 53138767
Angioedema 45.27 9.42 196 115365 41880 53191625
Therapeutic product effect incomplete 43.37 9.42 83 115478 91701 53141804
Hepatocellular injury 42.37 9.42 7 115554 29979 53203526
Interstitial lung disease 39.82 9.42 240 115321 58382 53175123
Pain 38.73 9.42 975 114586 587423 52646082
Ill-defined disorder 37.69 9.42 31 115530 49413 53184092
Anaphylactic reaction 36.00 9.42 233 115328 58093 53175412
Upper respiratory tract inflammation 35.17 9.42 37 115524 2837 53230668
Abdominal discomfort 35.06 9.42 308 115253 220754 53012751
Completed suicide 34.97 9.42 167 115394 138034 53095471
Enterocolitis 34.67 9.42 58 115503 6994 53226511
Mobility decreased 34.29 9.42 71 115490 76200 53157305
Torsade de pointes 33.80 9.42 82 115479 12923 53220582
Urticaria 32.96 9.42 444 115117 135441 53098064
Knee arthroplasty 32.51 9.42 16 115545 33553 53199952
Sopor 31.94 9.42 4 115557 21080 53212425
Chest discomfort 30.34 9.42 340 115221 99355 53134150
Cerebral infarction 30.33 9.42 119 115442 24325 53209180
Urinary tract infection 30.16 9.42 706 114855 239197 52994308
Diarrhoea 29.99 9.42 1648 113913 623898 52609607
Gallbladder disorder 29.88 9.42 97 115464 18068 53215437
Periorbital oedema 29.24 9.42 46 115515 5269 53228236
Lip swelling 28.71 9.42 126 115435 27075 53206430
Mental status changes 28.15 9.42 164 115397 39407 53194098
End stage renal disease 28.03 9.42 49 115512 6122 53227383
Exposure during pregnancy 26.52 9.42 160 115401 124700 53108805
Red blood cell sedimentation rate increased 26.23 9.42 14 115547 28043 53205462
Psoriatic arthropathy 26.04 9.42 40 115521 48150 53185355
Overdose 25.63 9.42 133 115428 107603 53125902
Drug resistance 23.50 9.42 7 115554 19955 53213550
Constipation 23.43 9.42 579 114982 197833 53035672
Haemorrhage subcutaneous 23.21 9.42 31 115530 3060 53230445
Impaired healing 23.17 9.42 67 115494 64138 53169367
Febrile neutropenia 23.06 9.42 337 115224 104599 53128906
Pneumonia 22.99 9.42 1090 114471 406079 52827426
Foetal exposure during pregnancy 22.68 9.42 25 115536 34690 53198815
Loss of personal independence in daily activities 22.28 9.42 77 115484 69738 53163767
Decreased appetite 22.11 9.42 616 114945 214358 53019147
Blood alkaline phosphatase increased 21.25 9.42 158 115403 41204 53192301
Renal injury 21.14 9.42 58 115503 9846 53223659
Basophil count decreased 20.64 9.42 8 115553 98 53233407
Acute respiratory failure 20.60 9.42 127 115434 31131 53202374
Hip arthroplasty 20.58 9.42 18 115543 27844 53205661
Lymphocyte stimulation test positive 20.14 9.42 14 115547 607 53232898
Nausea 20.10 9.42 1899 113662 754192 52479313
Dyspepsia 19.82 9.42 256 115305 77344 53156161
Hypoxia 19.80 9.42 196 115365 55484 53178021
Pyrexia 19.80 9.42 1065 114496 402128 52831377
Biliary dyskinesia 19.71 9.42 27 115534 2730 53230775
Infective pulmonary exacerbation of cystic fibrosis 19.65 9.42 61 115500 11095 53222410
Chest pain 19.56 9.42 545 115016 189640 53043865
Ventricular tachycardia 19.30 9.42 83 115478 17679 53215826
Coma 18.92 9.42 211 115350 61572 53171933
Dizziness 18.61 9.42 985 114576 371274 52862231
Acquired haemophilia 18.56 9.42 16 115545 956 53232549
Hospice care 18.51 9.42 41 115520 6089 53227416
Palmar erythema 18.28 9.42 20 115541 1604 53231901
Blood potassium decreased 18.27 9.42 150 115411 40310 53193195
Fibromyalgia 18.19 9.42 43 115518 44032 53189473
Neuropathy peripheral 18.03 9.42 319 115242 102868 53130637
Drug eruption 17.85 9.42 104 115457 24990 53208515
Cytokine release syndrome 17.75 9.42 48 115513 8081 53225424
Serotonin syndrome 17.27 9.42 19 115542 26387 53207118
Rebound acid hypersecretion 17.01 9.42 10 115551 323 53233182
Respiratory alkalosis 16.97 9.42 25 115536 2703 53230802
Premature baby 16.93 9.42 11 115550 19790 53213715
Throat irritation 16.83 9.42 122 115439 31559 53201946
Cholecystitis acute 16.81 9.42 46 115515 7797 53225708
Rheumatoid nodule 16.26 9.42 3 115558 11861 53221644
Hepatotoxicity 16.18 9.42 22 115539 27858 53205647
Full blood count decreased 16.07 9.42 98 115463 23931 53209574
Arthritis 15.95 9.42 117 115444 87181 53146324
Cystitis noninfective 15.92 9.42 14 115547 859 53232646
Erythema multiforme 15.90 9.42 54 115507 10295 53223210
Gastrointestinal disorder 15.79 9.42 122 115439 89882 53143623
Gallbladder injury 15.67 9.42 17 115544 1350 53232155
Gastritis 15.65 9.42 133 115428 36101 53197404
Swelling face 15.62 9.42 191 115370 56977 53176528
Abdominal distension 15.51 9.42 251 115310 79539 53153966
Lupus hepatitis 15.49 9.42 5 115556 34 53233471
Cholinergic syndrome 15.44 9.42 10 115551 385 53233120
Injection site reaction 15.29 9.42 58 115503 51108 53182397
Protein total decreased 15.19 9.42 37 115524 5846 53227659
Sepsis 15.15 9.42 420 115141 146009 53087496
Muscle spasticity 15.13 9.42 10 115551 17828 53215677
Throat tightness 15.11 9.42 91 115470 22125 53211380
Drug interaction 15.01 9.42 361 115200 218968 53014537
Injection site pain 15.00 9.42 165 115396 113226 53120279
Device expulsion 14.93 9.42 26 115535 29787 53203718
Anaphylactoid reaction 14.88 9.42 28 115533 3703 53229802
Hereditary angioedema 14.75 9.42 38 115523 6215 53227290
Hypokalaemia 14.65 9.42 292 115269 96225 53137280
Blister 14.65 9.42 105 115456 78648 53154857
Haematocrit decreased 14.56 9.42 134 115427 37197 53196308
Cholestasis 14.39 9.42 25 115536 28670 53204835
Somnolence 14.37 9.42 470 115091 167264 53066241
Blood pressure fluctuation 14.32 9.42 35 115526 35435 53198070
White blood cell count increased 14.19 9.42 158 115403 46087 53187418
Amino acid level decreased 14.17 9.42 5 115556 46 53233459
Red blood cell count decreased 14.06 9.42 129 115432 35774 53197731
Cholelithiasis 13.99 9.42 143 115418 40821 53192684
Burkholderia test positive 13.92 9.42 6 115555 98 53233407
Weight increased 13.91 9.42 337 115224 204230 53029275
Injection site bruising 13.79 9.42 39 115522 37607 53195898
Congenital neuropathy 13.77 9.42 4 115557 18 53233487
Disease progression 13.73 9.42 303 115258 101617 53131888
Intentional self-injury 13.64 9.42 21 115540 25263 53208242
Victim of chemical submission 13.54 9.42 8 115553 261 53233244
Hyperuricaemia 13.51 9.42 33 115528 5223 53228282
Small intestinal obstruction 13.47 9.42 73 115488 17074 53216431
Tubulointerstitial nephritis 13.47 9.42 71 115490 16433 53217072
Blood magnesium decreased 13.45 9.42 56 115505 11758 53221747
Lactic acidosis 13.35 9.42 39 115522 37214 53196291
Irritable bowel syndrome 13.33 9.42 49 115512 43583 53189922
Granulocytopenia 13.33 9.42 34 115527 5526 53227979
Dyspnoea 13.31 9.42 1457 114104 584775 52648730
Breast adenoma 13.22 9.42 5 115556 57 53233448
Medication error 13.08 9.42 38 115523 36327 53197178
Allergy test positive 13.03 9.42 9 115552 386 53233119
Pyuria 12.99 9.42 18 115543 1840 53231665
Cytomegalovirus enterocolitis 12.92 9.42 11 115550 646 53232859
Therapeutic response decreased 12.90 9.42 56 115505 47513 53185992
Brain natriuretic peptide increased 12.74 9.42 31 115530 4894 53228611
Putamen haemorrhage 12.72 9.42 7 115554 199 53233306
Ileus 12.67 9.42 65 115496 14890 53218615
Hypoparathyroidism 12.41 9.42 11 115550 682 53232823
Laboratory test abnormal 12.40 9.42 93 115468 24316 53209189
Asteatosis 12.36 9.42 5 115556 69 53233436
Swollen tongue 12.34 9.42 112 115449 30968 53202537
Blood bilirubin increased 12.33 9.42 125 115436 35605 53197900
Extrapyramidal disorder 11.87 9.42 6 115555 12396 53221109
Gastrointestinal haemorrhage 11.85 9.42 242 115319 80088 53153417
Xanthogranuloma 11.81 9.42 3 115558 7 53233498
Impaired work ability 11.81 9.42 8 115553 14082 53219423
Stress cardiomyopathy 11.71 9.42 43 115518 8519 53224986
Blood urea increased 11.71 9.42 97 115464 26134 53207371
Osteoarthritis 11.69 9.42 97 115464 70389 53163116
Neurological examination abnormal 11.64 9.42 7 115554 236 53233269
Infection 11.62 9.42 284 115277 171921 53061584
Atrioventricular block complete 11.60 9.42 41 115520 7974 53225531
Condition aggravated 11.53 9.42 526 115035 296608 52936897
Back pain 11.51 9.42 619 114942 233628 52999877
Therapy non-responder 11.47 9.42 61 115500 49059 53184446
Feeling hot 11.43 9.42 139 115422 41405 53192100
Plasma cell myeloma 11.41 9.42 156 115405 47718 53185787
Blood creatine phosphokinase MB increased 11.39 9.42 14 115547 1272 53232233
Liver injury 11.32 9.42 19 115542 22084 53211421
Haemoglobin decreased 11.31 9.42 383 115178 136924 53096581
Hypoalbuminaemia 11.04 9.42 50 115511 10886 53222619
Intraductal papillary breast neoplasm 11.03 9.42 3 115558 10 53233495
Contusion 11.02 9.42 171 115390 110561 53122944
Musculoskeletal pain 10.94 9.42 107 115454 75093 53158412
Chills 10.92 9.42 301 115260 104547 53128958
Anaemia 10.91 9.42 717 114844 276001 52957504
Coronary artery dissection 10.90 9.42 11 115550 803 53232702
Hyperlipidaemia 10.86 9.42 76 115485 19439 53214066
Ovarian cancer recurrent 10.85 9.42 13 115548 1150 53232355
Pulmonary hypertension 10.83 9.42 126 115435 37144 53196361
Restless arm syndrome 10.79 9.42 4 115557 43 53233462
Pityriasis lichenoides et varioliformis acuta 10.55 9.42 4 115557 46 53233459
Pupils unequal 10.46 9.42 14 115547 1385 53232120
Allergic transfusion reaction 10.39 9.42 4 115557 48 53233457
Deep vein thrombosis 10.39 9.42 244 115317 82669 53150836
Dermatitis acneiform 10.37 9.42 27 115534 4443 53229062
Vascular resistance systemic decreased 10.33 9.42 5 115556 108 53233397
Reticulocyte percentage increased 10.24 9.42 3 115558 14 53233491
Myocarditis infectious 10.24 9.42 3 115558 14 53233491
Inflammation 10.23 9.42 77 115484 57059 53176446
Blood albumin decreased 10.17 9.42 60 115501 14482 53219023
Tinea pedis 10.10 9.42 14 115547 1431 53232074
Lymphocyte count decreased 10.09 9.42 99 115462 27953 53205552
Ovarian cancer 10.09 9.42 33 115528 6169 53227336
Therapeutic hypothermia 10.07 9.42 3 115558 15 53233490
Mean arterial pressure increased 10.07 9.42 3 115558 15 53233490
Pyelonephritis acute 10.03 9.42 27 115534 4532 53228973
Seasonal allergy 10.01 9.42 62 115499 15223 53218282
Haemolytic anaemia 10.00 9.42 47 115514 10392 53223113
COVID-19 9.97 9.42 123 115438 36765 53196740
Hypoaesthesia 9.97 9.42 367 115194 132628 53100877
Neuroleptic malignant syndrome 9.86 9.42 7 115554 12026 53221479
Hypergeusia 9.76 9.42 3 115558 17 53233488
Histamine level increased 9.76 9.42 3 115558 17 53233488

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
Drug ineffective 148.93 9.96 478 80717 382999 32049332
Hepatic function abnormal 148.81 9.96 339 80856 44501 32387830
Drug abuse 119.45 9.96 27 81168 80216 32352115
Platelet count decreased 100.58 9.96 557 80638 114034 32318297
Alanine aminotransferase increased 97.96 9.96 422 80773 78057 32354274
Liver disorder 92.70 9.96 228 80967 31426 32400905
Aspartate aminotransferase increased 92.15 9.96 369 80826 66060 32366271
Toxicity to various agents 82.82 9.96 203 80992 177838 32254493
Disseminated intravascular coagulation 73.30 9.96 172 81023 23004 32409327
White blood cell count decreased 73.21 9.96 433 80762 90765 32341566
Off label use 71.58 9.96 460 80735 305860 32126471
Completed suicide 70.69 9.96 76 81119 92441 32339890
General physical health deterioration 66.60 9.96 116 81079 115143 32317188
Drug interaction 55.95 9.96 318 80877 217867 32214464
Neutrophil count decreased 55.37 9.96 249 80946 46890 32385441
Chronic kidney disease 46.82 9.96 211 80984 39764 32392567
Blood lactate dehydrogenase increased 45.76 9.96 139 81056 21666 32410665
Rheumatoid arthritis 43.29 9.96 29 81166 44515 32387816
Drug resistance 40.17 9.96 5 81190 22960 32409371
Interstitial lung disease 38.41 9.96 286 80909 64715 32367616
Treatment failure 37.39 9.96 26 81169 39137 32393194
Upper respiratory tract inflammation 34.92 9.96 33 81162 1924 32430407
Blood alkaline phosphatase increased 33.52 9.96 164 81031 31968 32400363
Cerebral infarction 33.26 9.96 147 81048 27467 32404864
Foetal exposure during pregnancy 31.44 9.96 34 81161 41267 32391064
Lymphocyte stimulation test positive 30.86 9.96 22 81173 859 32431472
Product use in unapproved indication 30.71 9.96 113 81082 87091 32345240
Overdose 29.90 9.96 114 81081 86963 32345368
Infusion related reaction 29.45 9.96 205 80990 45394 32386937
Pyrexia 27.39 9.96 1016 80179 318952 32113379
Pneumonitis 27.39 9.96 148 81047 29986 32402345
Contraindicated product administered 25.37 9.96 8 81187 19068 32413263
Psoriasis 25.20 9.96 48 81147 46075 32386256
Decreased appetite 25.01 9.96 551 80644 160262 32272069
Therapeutic product effect incomplete 24.40 9.96 41 81154 41300 32391031
End stage renal disease 23.63 9.96 58 81137 7979 32424352
Drug intolerance 23.51 9.96 57 81138 50178 32382153
Haematocrit decreased 22.64 9.96 146 81049 31516 32400815
Pneumonia 22.28 9.96 1092 80103 354160 32078171
Blood creatine phosphokinase MB increased 22.13 9.96 26 81169 1951 32430380
Blood bilirubin increased 21.97 9.96 169 81026 38615 32393716
Acute respiratory failure 21.49 9.96 134 81061 28594 32403737
Pneumonia bacterial 21.26 9.96 67 81128 10649 32421682
Rash 20.95 9.96 677 80518 208656 32223675
Blood urea increased 20.20 9.96 144 81051 32129 32400202
Blood albumin decreased 19.60 9.96 74 81121 12879 32419452
Enterocolitis 19.52 9.96 51 81144 7289 32425042
Erythema multiforme 19.50 9.96 58 81137 8934 32423397
Hypoxia 19.22 9.96 207 80988 51925 32380406
Lactic acidosis 19.11 9.96 34 81161 33502 32398829
Urticaria 18.96 9.96 230 80965 59384 32372947
Intentional product misuse 18.42 9.96 39 81156 36012 32396319
Cytokine release syndrome 17.80 9.96 74 81121 13461 32418870
Pneumonia aspiration 17.36 9.96 168 81027 40988 32391343
Constipation 17.16 9.96 425 80770 125948 32306383
Human ehrlichiosis 16.60 9.96 9 81186 214 32432117
Cholangitis acute 16.47 9.96 15 81180 834 32431497
Mast cell activation syndrome 16.33 9.96 8 81187 153 32432178
Wound secretion 16.22 9.96 26 81169 2621 32429710
Intentional product use issue 15.99 9.96 53 81142 42158 32390173
Hepatocellular injury 15.99 9.96 24 81171 25294 32407037
Ventricular tachycardia 15.97 9.96 114 81081 25442 32406889
Blood pressure ambulatory increased 15.91 9.96 6 81189 58 32432273
PO2 increased 15.85 9.96 13 81182 627 32431704
Rash maculo-papular 15.44 9.96 29 81166 27993 32404338
Psychotic disorder 15.35 9.96 21 81174 22999 32409332
Febrile neutropenia 15.32 9.96 399 80796 119167 32313164
Intentional overdose 15.23 9.96 53 81142 41548 32390783
Anaphylactic reaction 15.19 9.96 128 81067 30044 32402287
Joint swelling 15.12 9.96 72 81123 51663 32380668
Gastrointestinal mucosal necrosis 15.11 9.96 8 81187 181 32432150
Glossectomy 14.99 9.96 3 81192 0 32432331
Catheter site haemorrhage 14.84 9.96 23 81172 2252 32430079
Infective pulmonary exacerbation of cystic fibrosis 14.84 9.96 52 81143 8727 32423604
CADASIL 14.40 9.96 6 81189 77 32432254
Ultrasound skull abnormal 14.40 9.96 6 81189 77 32432254
Torsade de pointes 14.38 9.96 46 81149 7369 32424962
Cardiac autonomic neuropathy 14.20 9.96 6 81189 80 32432251
Magnetic resonance imaging spinal abnormal 14.13 9.96 6 81189 81 32432250
Lower respiratory tract infection 13.83 9.96 33 81162 29210 32403121
Visual evoked potentials abnormal 13.81 9.96 6 81189 86 32432245
Polyneuropathy 13.67 9.96 8 81187 13207 32419124
Aplastic anaemia 13.63 9.96 45 81150 7328 32425003
Sepsis 13.44 9.96 504 80691 158330 32274001
Convulsive threshold lowered 13.44 9.96 11 81184 529 32431802
Gastrooesophageal reflux disease 13.30 9.96 139 81056 34599 32397732
Blood pressure decreased 13.29 9.96 190 81005 50890 32381441
Drug dependence 13.21 9.96 24 81171 23460 32408871
Convulsions local 13.21 9.96 4 81191 18 32432313
Hypertensive crisis 13.04 9.96 3 81192 8814 32423517
Protein total decreased 12.99 9.96 35 81160 5095 32427236
Hiccups 12.93 9.96 54 81141 9841 32422490
Pneumonia staphylococcal 12.85 9.96 26 81169 3142 32429189
Burkholderia test positive 12.81 9.96 10 81185 449 32431882
Anal erosion 12.55 9.96 4 81191 22 32432309
Central nervous system inflammation 12.43 9.96 6 81189 111 32432220
Respiratory failure 12.40 9.96 353 80842 106829 32325502
Supine hypertension 12.39 9.96 9 81186 362 32431969
Renal impairment 12.39 9.96 309 80886 91663 32340668
Amino acid level decreased 12.38 9.96 5 81190 59 32432272
Cerebral microangiopathy 11.98 9.96 7 81188 193 32432138
Eczema asteatotic 11.98 9.96 7 81188 193 32432138
Ventricular flutter 11.87 9.96 5 81190 66 32432265
Double stranded DNA antibody positive 11.78 9.96 6 81189 125 32432206
Arthropathy 11.76 9.96 24 81171 22465 32409866
Sputum retention 11.76 9.96 10 81185 507 32431824
Cardiogenic shock 11.73 9.96 21 81174 20641 32411690
Nipple swelling 11.70 9.96 3 81192 6 32432325
Post procedural haematoma 11.58 9.96 17 81178 1587 32430744
Amino acid level increased 11.55 9.96 9 81186 403 32431928
Conduction disorder 11.45 9.96 19 81176 1971 32430360
Jaundice hepatocellular 11.42 9.96 5 81190 73 32432258
Aggression 11.40 9.96 55 81140 39334 32392997
Acute kidney injury 11.40 9.96 608 80587 292860 32139471
Saccadic eye movement 11.25 9.96 6 81189 138 32432193
White blood cell count increased 11.17 9.96 155 81040 41247 32391084
Ejaculation delayed 11.11 9.96 7 81188 222 32432109
Stomatitis 11.01 9.96 151 81044 40078 32392253
Progressive multifocal leukoencephalopathy 11.00 9.96 5 81190 9526 32422805
Death 10.96 9.96 815 80380 381702 32050629
Product use issue 10.90 9.96 82 81113 52695 32379636
Cholestasis 10.90 9.96 33 81162 27000 32405331
Granulocyte count decreased 10.88 9.96 11 81184 697 32431634
Viral rash 10.84 9.96 5 81190 83 32432248
Laboratory test abnormal 10.71 9.96 83 81112 19004 32413327
Musculoskeletal stiffness 10.70 9.96 56 81139 39208 32393123
Hypoalbuminaemia 10.69 9.96 58 81137 11764 32420567
Haemorrhagic diathesis 10.60 9.96 23 81172 2919 32429412
Inappropriate schedule of product administration 10.54 9.96 69 81126 45756 32386575
Granulocytopenia 10.51 9.96 38 81157 6477 32425854
Blood pH decreased 10.50 9.96 20 81175 2313 32430018
Sputum culture positive 10.44 9.96 18 81177 1926 32430405
Stevens-Johnson syndrome 10.30 9.96 81 81114 18628 32413703
Psoriatic arthropathy 10.27 9.96 18 81177 17842 32414489
Gastrointestinal tract mucosal pigmentation 10.27 9.96 8 81187 358 32431973
Depressed level of consciousness 10.25 9.96 151 81044 40696 32391635
Hepatitis fulminant 10.23 9.96 28 81167 4115 32428216
Oral pruritus 10.15 9.96 7 81188 259 32432072
Pancreatic enlargement 10.05 9.96 5 81190 99 32432232
Urine osmolarity decreased 9.99 9.96 4 81191 46 32432285
Accidental exposure to product 9.96 9.96 8 81187 11194 32421137
Aortic rupture 9.96 9.96 5 81190 101 32432230

Pharmacologic Action:

SourceCodeDescription
ATC A02BA03 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
H2-receptor antagonists
ATC A02BA53 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
H2-receptor antagonists
FDA MoA N0000000151 Histamine H2 Receptor Antagonists
CHEBI has role CHEBI:37961 H2-receptor blockers
CHEBI has role CHEBI:49201 anti-ulcer agents
CHEBI has role CHEBI:50183 cytochrome P450 inhibitor
MeSH PA D000897 Anti-Ulcer Agents
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006635 Histamine H2 Antagonists
MeSH PA D018377 Neurotransmitter Agents
FDA EPC N0000175784 Histamine-2 Receptor Antagonist

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Heartburn indication 16331000
Erosive esophagitis indication 40719004
Duodenal ulcer disease indication 51868009 DOID:1724
Zollinger-Ellison syndrome indication 53132006 DOID:0050782
Peptic reflux disease indication 57643001
Indigestion indication 162031009
Gastroesophageal reflux disease indication 235595009 DOID:8534
Gastric ulcer indication 397825006 DOID:10808
Dyspepsia Prevention indication
Maintenance of Healing Duodenal Ulcer indication
Heartburn Prevention indication
Upper gastrointestinal hemorrhage off-label use 37372002
Prevention of Stress Ulcer off-label use
Constipation contraindication 14760008 DOID:2089
Sarcoidosis contraindication 31541009 DOID:11335
Dehydration contraindication 34095006
Diarrhea contraindication 62315008
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Kidney disease contraindication 90708001 DOID:557
Kidney stone contraindication 95570007
Impaired renal function disorder contraindication 197663003
Osteolysis contraindication 203522001
Disease of liver contraindication 235856003 DOID:409
Malignant tumor of stomach contraindication 363349007 DOID:10534

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.84 acidic
pKa2 12.0 acidic
pKa3 6.97 Basic
pKa4 6.37 Basic
pKa5 2.56 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
26.6MG;800MG DUEXIS HORIZON N022519 April 23, 2011 RX TABLET ORAL 8067451 July 18, 2026 RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS
26.6MG;800MG DUEXIS HORIZON N022519 April 23, 2011 RX TABLET ORAL 8501228 July 18, 2026 RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Histamine H2 receptor GPCR ANTAGONIST Kd 7.93 WOMBAT-PK CHEMBL
Carbonic anhydrase 2 Enzyme Ki 7.24 CHEMBL
Carbonic anhydrase 1 Enzyme Ki 6.04 CHEMBL
Carbonic anhydrase 4 Enzyme Ki 6.03 CHEMBL
Carbonic anhydrase 9 Enzyme Ki 6.90 CHEMBL
Carbonic anhydrase 12 Enzyme Ki 7.34 CHEMBL
Carbonic anhydrase 5A, mitochondrial Enzyme Ki 5.84 CHEMBL
Carbonic anhydrase 5B, mitochondrial Enzyme Ki 5.27 CHEMBL
Carbonic anhydrase 7 Enzyme Ki 8.52 CHEMBL
Carbonic anhydrase 6 Enzyme Ki 7.01 CHEMBL
Carbonic anhydrase 14 Enzyme Ki 6.17 CHEMBL
Carbonic anhydrase 13 Enzyme Ki 6.77 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 4.44 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 6.12 CHEMBL
Multidrug and toxin extrusion protein 2 Transporter IC50 4.44 CHEMBL
Heat shock protein HSP 90-alpha Cytosolic other IC50 5.30 WOMBAT-PK
Solute carrier family 22 member 3 Transporter IC50 4.97 CHEMBL
Histamine H2 receptor GPCR Kd 7 CHEMBL

External reference:

IDSource
4017970 VUID
N0000146320 NUI
D00318 KEGG_DRUG
4017970 VANDF
C0015620 UMLSCUI
CHEBI:4975 CHEBI
FO9 PDB_CHEM_ID
CHEMBL902 ChEMBL_ID
DB00927 DRUGBANK_ID
D015738 MESH_DESCRIPTOR_UI
5353622 PUBCHEM_CID
7074 IUPHAR_LIGAND_ID
5217 INN_ID
5QZO15J2Z8 UNII
4278 RXNORM
41331 MMSL
4713 MMSL
d00141 MMSL
003417 NDDF
387211002 SNOMEDCT_US
39128000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ibuprofen and famotidine HUMAN PRESCRIPTION DRUG LABEL 2 0093-8107 TABLET, FILM COATED 26.60 mg ORAL ANDA 28 sections
Good Sense Dual Action Complete HUMAN OTC DRUG LABEL 3 0113-0032 TABLET, CHEWABLE 10 mg ORAL ANDA 15 sections
good sense acid reducer HUMAN OTC DRUG LABEL 1 0113-0141 TABLET, FILM COATED 10 mg ORAL ANDA 15 sections
Good Sense Acid Reducer HUMAN OTC DRUG LABEL 1 0113-0194 TABLET, FILM COATED 20 mg ORAL ANDA 15 sections
basic care acid reducer HUMAN OTC DRUG LABEL 1 0113-7141 TABLET, FILM COATED 10 mg ORAL ANDA 15 sections
Basic Care famotidine HUMAN OTC DRUG LABEL 1 0113-7194 TABLET, FILM COATED 20 mg ORAL ANDA 14 sections
basic care dual action complete HUMAN OTC DRUG LABEL 3 0113-7321 TABLET, CHEWABLE 10 mg ORAL ANDA 15 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0172-5728 TABLET, FILM COATED 20 mg ORAL ANDA 25 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0172-5729 TABLET, FILM COATED 40 mg ORAL ANDA 25 sections
Pepcid HUMAN PRESCRIPTION DRUG LABEL 1 0187-4420 TABLET, FILM COATED 20 mg ORAL ANDA 25 sections
Pepcid HUMAN PRESCRIPTION DRUG LABEL 1 0187-4440 TABLET, FILM COATED 40 mg ORAL ANDA 25 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0338-5197 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 22 sections
Acid ControllerOriginal Strength HUMAN OTC DRUG LABEL 1 0363-0141 TABLET, FILM COATED 10 mg ORAL ANDA 15 sections
Acid Reducer Complete HUMAN OTC DRUG LABEL 3 0363-0511 TABLET, CHEWABLE 10 mg ORAL ANDA 15 sections
Acid Controller HUMAN OTC DRUG LABEL 1 0363-0701 TABLET, FILM COATED 20 mg ORAL ANDA 15 sections
Acid Reducer Complete HUMAN OTC DRUG LABEL 3 0363-0713 TABLET, CHEWABLE 10 mg ORAL ANDA 15 sections
Famotidine Human OTC Drug Label 1 0363-1899 TABLET, FILM COATED 20 mg ORAL ANDA 16 sections
Famotidine Human OTC Drug Label 1 0363-4400 TABLET, FILM COATED 10 mg ORAL ANDA 16 sections
Famotidine Human OTC Drug Label 1 0363-5300 TABLET, FILM COATED 20 mg ORAL ANDA 16 sections
Rugby Famotidine HUMAN OTC DRUG LABEL 1 0536-1298 TABLET, FILM COATED 20 mg ORAL ANDA 15 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0615-4582 TABLET, FILM COATED 20 mg ORAL ANDA 20 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8301 TABLET, FILM COATED 40 mg ORAL ANDA 20 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0641-6021 INJECTION 10 mg INTRAVENOUS ANDA 22 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0641-6022 INJECTION 10 mg INTRAVENOUS ANDA 22 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0641-6023 INJECTION 10 mg INTRAVENOUS ANDA 22 sections
heartburn relieforiginal strength HUMAN OTC DRUG LABEL 1 0904-5529 TABLET 10 mg ORAL ANDA 15 sections
Major Heartburn ReliefMaximum Strength HUMAN OTC DRUG LABEL 1 0904-5780 TABLET, FILM COATED 20 mg ORAL ANDA 15 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0904-7193 TABLET, FILM COATED 20 mg ORAL ANDA 24 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 10544-481 TABLET 20 mg ORAL ANDA 21 sections
up and up famotidine complete HUMAN OTC DRUG LABEL 3 11673-007 TABLET, CHEWABLE 10 mg ORAL ANDA 15 sections