famotidine ๐Ÿถ Veterinary Use | 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 ยตM/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 431.28 9.60 797 118168 818536 49667623
Contraindicated product administered 276.27 9.60 19 118946 148939 50337220
Synovitis 266.21 9.60 5 118960 123860 50362299
Drug intolerance 251.89 9.60 100 118865 219004 50267155
Hand deformity 200.71 9.60 8 118957 100191 50385968
Joint swelling 198.47 9.60 171 118794 245115 50241044
Systemic lupus erythematosus 188.37 9.60 49 118916 140573 50345586
Glossodynia 182.60 9.60 27 118938 115542 50370617
Treatment failure 180.51 9.60 50 118915 137587 50348572
Arthropathy 170.33 9.60 79 118886 157827 50328332
Therapeutic product effect decreased 170.08 9.60 54 118911 135996 50350163
Rheumatoid arthritis 165.26 9.60 140 118825 202410 50283749
Hepatic function abnormal 132.72 9.60 259 118706 32422 50453737
Pneumonia aspiration 127.48 9.60 247 118718 30757 50455402
Pericarditis 122.86 9.60 19 118946 78670 50407489
Wound 121.91 9.60 48 118917 105746 50380413
Gastrooesophageal reflux disease 115.70 9.60 419 118546 76009 50410150
Platelet count decreased 110.05 9.60 499 118466 100227 50385932
White blood cell count decreased 109.96 9.60 554 118411 116168 50369991
Lower respiratory tract infection 108.37 9.60 44 118921 95157 50391002
Maternal exposure during pregnancy 106.88 9.60 131 118834 159647 50326512
Alopecia 98.85 9.60 274 118691 244773 50241386
Chronic kidney disease 97.49 9.60 258 118707 39513 50446646
Off label use 88.57 9.60 703 118262 473723 50012436
Helicobacter infection 87.44 9.60 8 118957 49694 50436465
Duodenal ulcer perforation 86.94 9.60 5 118960 45606 50440553
Toxicity to various agents 85.38 9.60 238 118727 212261 50273898
Hepatic enzyme increased 83.34 9.60 121 118844 137259 50348900
Drug abuse 81.73 9.60 20 118945 59826 50426333
Swelling 76.29 9.60 231 118734 200641 50285518
Discomfort 75.50 9.60 86 118879 108294 50377865
Musculoskeletal stiffness 73.28 9.60 118 118847 128363 50357796
Disseminated intravascular coagulation 72.25 9.60 138 118827 16997 50469162
Folliculitis 69.85 9.60 6 118959 39219 50446940
Product use issue 69.69 9.60 155 118810 149320 50336839
Arthralgia 69.04 9.60 679 118286 438023 50048136
General physical health deterioration 68.64 9.60 145 118820 142289 50343870
Aspartate aminotransferase increased 68.41 9.60 363 118602 77635 50408524
Abdominal discomfort 66.55 9.60 299 118666 231342 50254817
Neutrophil count decreased 59.47 9.60 240 118725 45786 50440373
Flushing 55.45 9.60 307 118658 66708 50419451
Dehydration 54.95 9.60 574 118391 151875 50334284
Cholecystitis chronic 53.87 9.60 88 118877 9581 50476578
Alanine aminotransferase increased 53.19 9.60 373 118592 87986 50398173
Liver disorder 52.89 9.60 200 118765 37022 50449137
Therapeutic product effect incomplete 52.21 9.60 84 118881 91431 50394728
Ill-defined disorder 52.04 9.60 32 118933 54622 50431537
Pain 51.77 9.60 1005 117960 577898 49908261
Blood lactate dehydrogenase increased 51.11 9.60 130 118835 19432 50466727
Drug hypersensitivity 48.53 9.60 368 118597 250642 50235517
Angioedema 45.94 9.60 193 118772 37483 50448676
Interstitial lung disease 45.60 9.60 246 118719 52930 50433229
Knee arthroplasty 41.71 9.60 16 118949 35830 50450329
Mobility decreased 41.40 9.60 78 118887 79870 50406289
Butterfly rash 40.63 9.60 29 118936 1207 50484952
Upper respiratory tract inflammation 40.27 9.60 38 118927 2351 50483808
Chest discomfort 39.19 9.60 361 118604 92361 50393798
Hepatocellular injury 38.86 9.60 7 118958 25940 50460219
Anaphylactic reaction 38.47 9.60 238 118727 53817 50432342
Enterocolitis 36.90 9.60 60 118905 6507 50479652
Impaired healing 36.21 9.60 68 118897 69718 50416441
Completed suicide 36.19 9.60 173 118792 131716 50354443
Cerebral infarction 34.85 9.60 121 118844 21483 50464676
Diarrhoea 34.79 9.60 1703 117262 586773 49899386
Urticaria 34.75 9.60 461 118504 129100 50357059
Urinary tract infection 34.53 9.60 728 118237 223292 50262867
Torsade de pointes 34.47 9.60 82 118883 11753 50474406
Plasma cell myeloma 33.29 9.60 154 118811 31168 50454991
Sopor 32.91 9.60 4 118961 19875 50466284
Red blood cell sedimentation rate increased 32.80 9.60 14 118951 29402 50456757
Gallbladder disorder 31.69 9.60 99 118866 16643 50469516
Mental status changes 30.55 9.60 167 118798 36105 50450054
Constipation 30.08 9.60 608 118357 185100 50301059
Periorbital oedema 29.81 9.60 47 118918 4965 50481194
Decreased appetite 29.36 9.60 648 118317 200275 50285884
Exposure during pregnancy 29.12 9.60 166 118799 120849 50365310
Pneumonia 28.96 9.60 1125 117840 377276 50108883
Psoriatic arthropathy 28.91 9.60 41 118924 46991 50439168
Infective pulmonary exacerbation of cystic fibrosis 28.89 9.60 60 118905 7849 50478310
Hip arthroplasty 28.71 9.60 18 118947 30411 50455748
Lip swelling 28.07 9.60 124 118841 24612 50461547
Loss of personal independence in daily activities 26.95 9.60 80 118885 69970 50416189
Gastrointestinal disorder 26.43 9.60 123 118842 94333 50391826
Blood alkaline phosphatase increased 25.31 9.60 163 118802 37363 50448796
Acute respiratory failure 25.25 9.60 134 118831 28648 50457511
Overdose 24.97 9.60 135 118830 99592 50386567
Drug resistance 24.68 9.60 7 118958 18982 50467177
Haemorrhage subcutaneous 24.51 9.60 31 118934 2670 50483489
Irritable bowel syndrome 24.23 9.60 53 118912 51388 50434771
Hypoxia 24.15 9.60 204 118761 50919 50435240
Febrile neutropenia 23.93 9.60 342 118623 97325 50388834
Coma 22.79 9.60 219 118746 56660 50429499
End stage renal disease 22.71 9.60 45 118920 5692 50480467
Dizziness 22.44 9.60 1012 117953 345357 50140802
Pyrexia 22.32 9.60 1100 117865 379103 50107056
Nausea 21.76 9.60 1932 117033 703466 49782693
Lymphocyte stimulation test positive 21.71 9.60 14 118951 492 50485667
Neuropathy peripheral 21.44 9.60 333 118632 96424 50389735
Blister 21.18 9.60 116 118849 85302 50400857
Chest pain 21.14 9.60 555 118410 176327 50309832
Somnolence 21.11 9.60 495 118470 154490 50331669
Ventricular tachycardia 20.83 9.60 83 118882 15738 50470421
Fibromyalgia 20.64 9.60 47 118918 44931 50441228
Basophil count decreased 20.38 9.60 8 118957 93 50486066
Renal injury 20.22 9.60 55 118910 8556 50477603
Sepsis 20.13 9.60 431 118534 132494 50353665
Rheumatoid nodule 20.04 9.60 3 118962 12732 50473427
Foetal exposure during pregnancy 19.82 9.60 21 118944 27338 50458821
Biliary dyskinesia 19.63 9.60 27 118938 2523 50483636
Blood potassium decreased 19.38 9.60 151 118814 36794 50449365
Palmar erythema 19.28 9.60 21 118944 1542 50484617
Throat tightness 18.93 9.60 98 118867 20749 50465410
Drug eruption 18.76 9.60 107 118858 23499 50462660
Blood bilirubin increased 18.53 9.60 134 118831 31904 50454255
Blood pressure fluctuation 18.49 9.60 35 118930 35788 50450371
Acquired haemophilia 18.44 9.60 16 118949 887 50485272
Hereditary angioedema 18.40 9.60 40 118925 5402 50480757
Cholecystitis acute 18.33 9.60 47 118918 7059 50479100
Hospice care 17.91 9.60 41 118924 5731 50480428
Dermatitis atopic 17.80 9.60 31 118934 3555 50482604
Cystitis noninfective 17.80 9.60 15 118950 799 50485360
Throat irritation 17.80 9.60 127 118838 30112 50456047
Anaphylactoid reaction 17.64 9.60 30 118935 3376 50482783
Condition aggravated 17.58 9.60 548 118417 296510 50189649
Hepatotoxicity 17.47 9.60 23 118942 27203 50458956
Abdominal distension 17.34 9.60 254 118711 72649 50413510
Arthritis 17.26 9.60 126 118839 86595 50399564
Weight increased 17.18 9.60 353 118612 201538 50284621
Premature baby 17.09 9.60 11 118954 18326 50467833
Hypokalaemia 16.96 9.60 296 118669 87696 50398463
Asteatosis 16.94 9.60 6 118959 51 50486108
Respiratory alkalosis 16.93 9.60 25 118940 2494 50483665
Rebound acid hypersecretion 16.89 9.60 10 118955 301 50485858
Dyspnoea 16.86 9.60 1500 117465 546108 49940051
Serotonin syndrome 16.78 9.60 20 118945 24693 50461466
Atrioventricular block complete 16.70 9.60 46 118919 7209 50478950
Intentional product use issue 16.67 9.60 109 118856 76809 50409350
Erythema multiforme 16.66 9.60 53 118912 8997 50477162
White blood cell count increased 16.61 9.60 162 118803 42078 50444081
Injection site reaction 16.58 9.60 61 118904 49971 50436188
Injection site pain 16.48 9.60 174 118791 110850 50375309
COVID-19 16.45 9.60 175 118790 46487 50439672
Injection site bruising 16.41 9.60 39 118926 36729 50449430
Medication error 16.35 9.60 38 118927 36066 50450093
Cytokine release syndrome 16.29 9.60 51 118914 8583 50477576
Infection 16.05 9.60 298 118667 172656 50313503
Protein total decreased 15.94 9.60 37 118928 5219 50480940
Blood magnesium decreased 15.87 9.60 60 118905 11100 50475059
Contusion 15.78 9.60 178 118787 112005 50374154
Lupus hepatitis 15.76 9.60 5 118960 29 50486130
Therapy non-responder 15.76 9.60 64 118901 50958 50435201
Full blood count decreased 15.65 9.60 98 118867 22248 50463911
Disease progression 15.54 9.60 314 118651 95552 50390607
Anaemia 15.33 9.60 733 118232 251723 50234436
Gallbladder injury 15.30 9.60 17 118948 1277 50484882
Cholelithiasis 15.11 9.60 146 118819 37827 50448332
Cholinergic syndrome 15 9.60 10 118955 372 50485787
Congenital neuropathy 14.96 9.60 4 118961 11 50486148
Deep vein thrombosis 14.63 9.60 248 118717 73056 50413103
Hyperuricaemia 14.25 9.60 33 118932 4647 50481512
Small intestinal obstruction 14.22 9.60 75 118890 15993 50470166
Nasopharyngitis 14.22 9.60 345 118620 192582 50293577
Gastritis 14.22 9.60 129 118836 32854 50453305
Reversible cerebral vasoconstriction syndrome 14.20 9.60 21 118944 2098 50484061
Haematocrit decreased 14.17 9.60 135 118830 34841 50451318
Device expulsion 14.15 9.60 29 118936 28793 50457366
Chills 14.15 9.60 312 118653 96375 50389784
Device difficult to use 14.10 9.60 3 118962 9883 50476276
Amino acid level decreased 14.07 9.60 5 118960 43 50486116
Swelling face 14.02 9.60 187 118778 52408 50433751
Ileus 14.02 9.60 65 118900 13164 50472995
Hypoalbuminaemia 14.02 9.60 53 118912 9807 50476352
Asthma 13.95 9.60 291 118674 89046 50397113
Liver injury 13.92 9.60 23 118942 24783 50461376
Red blood cell count decreased 13.91 9.60 131 118834 33704 50452455
Blood urea increased 13.85 9.60 99 118866 23486 50462673
Musculoskeletal pain 13.83 9.60 106 118859 72071 50414088
Burkholderia test positive 13.78 9.60 8 118957 232 50485927
Cytomegalovirus enterocolitis 13.52 9.60 11 118954 558 50485601
Therapeutic response decreased 13.51 9.60 61 118904 47170 50438989
Dyspepsia 13.48 9.60 247 118718 73850 50412309
Tubulointerstitial nephritis 13.46 9.60 71 118894 15140 50471019
Hypervolaemia 13.25 9.60 104 118861 25395 50460764
Vomiting 13.24 9.60 1256 117709 459502 50026657
Pyuria 13.23 9.60 18 118947 1665 50484494
Hypoparathyroidism 13.10 9.60 11 118954 583 50485576
Victim of chemical submission 13.10 9.60 8 118957 255 50485904
Coronary artery dissection 13.10 9.60 12 118953 715 50485444
Feeling abnormal 13.08 9.60 387 118578 125105 50361054
Breast adenoma 13.06 9.60 5 118960 54 50486105
Osteoarthritis 13.03 9.60 101 118864 68505 50417654
Mast cell activation syndrome 12.97 9.60 9 118956 358 50485801
Impaired work ability 12.96 9.60 8 118957 13632 50472527
Ovarian cancer recurrent 12.94 9.60 13 118952 869 50485290
Haemoglobin decreased 12.91 9.60 391 118574 126825 50359334
Feeling hot 12.89 9.60 145 118820 39057 50447102
Granulocytopenia 12.88 9.60 34 118931 5197 50480962
Brain natriuretic peptide increased 12.79 9.60 31 118934 4496 50481663
Back pain 12.75 9.60 636 118329 219394 50266765
Putamen haemorrhage 12.74 9.60 7 118958 182 50485977
Muscle spasticity 12.66 9.60 13 118952 17171 50468988
Peripheral swelling 12.64 9.60 378 118587 205558 50280601
Drug tolerance decreased 12.62 9.60 3 118962 9157 50477002
Pulmonary hypertension 12.57 9.60 127 118838 33290 50452869
Extrapyramidal disorder 12.50 9.60 6 118959 11764 50474395
Intentional self-injury 12.45 9.60 22 118943 23090 50463069
Hyperlipidaemia 12.43 9.60 77 118888 17413 50468746
Swollen tongue 12.35 9.60 112 118853 28518 50457641
Emotional distress 12.30 9.60 112 118853 28551 50457608
Laboratory test abnormal 12.25 9.60 95 118870 23113 50463046
Ovarian cancer 12.20 9.60 33 118932 5116 50481043
Lactic acidosis 12.18 9.60 39 118926 33316 50452843
Allergy test positive 12.17 9.60 9 118956 396 50485763
Cholestasis 12.10 9.60 26 118939 25375 50460784
Blood albumin decreased 11.86 9.60 62 118903 13174 50472985
Blood creatine phosphokinase MB increased 11.81 9.60 14 118951 1128 50485031
Stress cardiomyopathy 11.72 9.60 43 118922 7844 50478315
Dermatitis acneiform 11.69 9.60 28 118937 4029 50482130
Inflammation 11.66 9.60 82 118883 56830 50429329
Xanthogranuloma 11.57 9.60 3 118962 7 50486152
Cough 11.53 9.60 685 118280 240579 50245580
Neurological examination abnormal 11.44 9.60 7 118958 224 50485935
Renal failure 11.43 9.60 330 118635 106303 50379856
Lymphocyte count decreased 11.39 9.60 103 118862 26204 50459955
Blood pressure systolic increased 11.24 9.60 44 118921 35405 50450754
Respiratory failure 11.14 9.60 287 118678 90894 50395265
Pleural effusion 11.03 9.60 260 118705 81194 50404965
Pityriasis lichenoides et varioliformis acuta 11.00 9.60 4 118961 37 50486122
Palpitations 10.84 9.60 295 118670 94211 50391948
Seasonal allergy 10.68 9.60 65 118900 14611 50471548
Allergic transfusion reaction 10.64 9.60 4 118961 41 50486118
Tinea pedis 10.63 9.60 14 118951 1255 50484904
Shock 10.61 9.60 84 118881 20566 50465593
Light chain analysis increased 10.60 9.60 13 118952 1085 50485074
Stoma site cellulitis 10.57 9.60 3 118962 11 50486148
Vascular resistance systemic decreased 10.57 9.60 5 118960 94 50486065
Gastrointestinal haemorrhage 10.54 9.60 236 118729 73085 50413074
Pyelonephritis acute 10.52 9.60 27 118938 4056 50482103
Restless arm syndrome 10.47 9.60 4 118961 43 50486116
Anxiety 10.41 9.60 514 118451 177092 50309067
Colitis ischaemic 10.35 9.60 47 118918 9436 50476723
Myocarditis infectious 10.18 9.60 3 118962 13 50486146
Intraductal papillary breast neoplasm 10.18 9.60 3 118962 13 50486146
Pneumonia bacterial 10.15 9.60 39 118926 7270 50478889
Haemolytic anaemia 10.10 9.60 46 118919 9246 50476913
Haematotoxicity 10.09 9.60 3 118962 7892 50478267
Joint stiffness 10.01 9.60 37 118928 30271 50455888
Reticulocyte percentage increased 10.00 9.60 3 118962 14 50486145
Status asthmaticus 9.94 9.60 11 118954 822 50485337
Neuroleptic malignant syndrome 9.94 9.60 7 118958 11123 50475036
Anaplastic astrocytoma 9.86 9.60 4 118961 51 50486108
Therapeutic hypothermia 9.83 9.60 3 118962 15 50486144
Mean arterial pressure increased 9.83 9.60 3 118962 15 50486144
Aplastic anaemia 9.81 9.60 40 118925 7663 50478496
Hypersensitivity 9.75 9.60 410 118555 214751 50271408
Tinnitus 9.68 9.60 105 118860 28027 50458132

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 176.81 9.78 483 82445 362687 29128912
Hepatic function abnormal 154.96 9.78 341 82587 38918 29452681
Drug abuse 144.42 9.78 25 82903 79858 29411741
Toxicity to various agents 105.95 9.78 204 82724 173457 29318142
Platelet count decreased 99.65 9.78 566 82362 104106 29387493
Off label use 98.29 9.78 472 82456 300328 29191271
Alanine aminotransferase increased 97.64 9.78 426 82502 70518 29421081
Aspartate aminotransferase increased 94.22 9.78 374 82554 59351 29432248
Liver disorder 92.92 9.78 226 82702 27523 29464076
Completed suicide 87.04 9.78 75 82853 90171 29401428
Disseminated intravascular coagulation 77.04 9.78 172 82756 19808 29471791
White blood cell count decreased 69.17 9.78 435 82493 82927 29408672
General physical health deterioration 62.48 9.78 121 82807 102736 29388863
Drug interaction 57.93 9.78 321 82607 197064 29294535
Neutrophil count decreased 53.46 9.78 253 82675 43314 29448285
Blood lactate dehydrogenase increased 44.80 9.78 137 82791 19072 29472527
Chronic kidney disease 44.33 9.78 211 82717 36205 29455394
Drug resistance 42.96 9.78 5 82923 21535 29470064
Interstitial lung disease 40.50 9.78 289 82639 57429 29434170
Treatment failure 40.31 9.78 27 82901 36912 29454687
Upper respiratory tract inflammation 38.99 9.78 34 82894 1586 29490013
Product use in unapproved indication 33.96 9.78 127 82801 86748 29404851
Cerebral infarction 33.76 9.78 148 82780 24527 29467072
Blood alkaline phosphatase increased 33.42 9.78 163 82765 28243 29463356
Lymphocyte stimulation test positive 33.10 9.78 22 82906 679 29490920
Overdose 32.98 9.78 114 82814 79705 29411894
Drug intolerance 30.15 9.78 56 82872 48323 29443276
Pyrexia 29.75 9.78 1034 81894 286588 29205011
Infusion related reaction 29.20 9.78 217 82711 43669 29447930
Contraindicated product administered 28.38 9.78 8 82920 18258 29473341
Rheumatoid arthritis 28.29 9.78 29 82899 32123 29459476
Pneumonitis 27.51 9.78 153 82775 27891 29463708
Pneumonia 27.14 9.78 1126 81802 319046 29172553
Foetal exposure during pregnancy 27.11 9.78 33 82895 33834 29457765
Therapeutic product effect incomplete 26.77 9.78 43 82885 39262 29452337
Acute respiratory failure 25.87 9.78 144 82784 26258 29465341
Decreased appetite 25.33 9.78 559 82369 144783 29346816
Aplastic anaemia 24.95 9.78 61 82867 7449 29484150
Intentional product misuse 23.53 9.78 38 82890 34623 29456976
Blood bilirubin increased 23.35 9.78 169 82759 33724 29457875
Intentional product use issue 22.45 9.78 54 82874 42444 29449155
Blood urea increased 22.23 9.78 145 82783 27967 29463632
Blood creatine phosphokinase MB increased 22.18 9.78 26 82902 1731 29489868
Pneumonia bacterial 22.12 9.78 67 82861 9276 29482323
Burkholderia test positive 22.12 9.78 20 82908 979 29490620
Erythema multiforme 21.83 9.78 59 82869 7658 29483941
Rash 21.51 9.78 690 82238 189129 29302470
Hypoxia 21.39 9.78 215 82713 47164 29444435
Haematocrit decreased 21.33 9.78 147 82781 28875 29462724
Febrile neutropenia 21.25 9.78 437 82491 111803 29379796
Infective pulmonary exacerbation of cystic fibrosis 20.02 9.78 50 82878 6186 29485413
Enterocolitis 19.90 9.78 52 82876 6614 29484985
Blood albumin decreased 19.85 9.78 75 82853 11620 29479979
End stage renal disease 19.13 9.78 56 82872 7608 29483991
Joint swelling 19.09 9.78 73 82855 49557 29442042
Plasma cell myeloma 18.52 9.78 172 82756 36943 29454656
Constipation 17.38 9.78 431 82497 113729 29377870
Intentional overdose 17.31 9.78 53 82875 38475 29453124
Cholangitis acute 17.30 9.78 15 82913 694 29490905
Pneumonia aspiration 17.21 9.78 168 82760 36569 29455030
Lactic acidosis 17.14 9.78 37 82891 30210 29461389
Human ehrlichiosis 16.42 9.78 9 82919 194 29491405
Ventricular tachycardia 16.39 9.78 114 82814 22460 29469139
Wound secretion 16.38 9.78 26 82902 2312 29489287
Urticaria 16.25 9.78 229 82699 54431 29437168
Blood pressure ambulatory increased 16.12 9.78 6 82922 49 29491550
Cytokine release syndrome 15.94 9.78 76 82852 13043 29478556
PO2 increased 15.38 9.78 13 82915 581 29491018
Gastrointestinal mucosal necrosis 15.13 9.78 8 82920 160 29491439
Eczema asteatotic 14.95 9.78 8 82920 164 29491435
Anaphylactic reaction 14.89 9.78 130 82798 27443 29464156
Cardiac autonomic neuropathy 14.89 9.78 6 82922 62 29491537
Renal impairment 14.84 9.78 315 82613 81018 29410581
Catheter site haemorrhage 14.66 9.78 23 82905 2025 29489574
Glossectomy 14.64 9.78 3 82925 0 29491599
Lower respiratory tract infection 14.53 9.78 33 82895 26469 29465130
CADASIL 14.47 9.78 6 82922 67 29491532
Sepsis 14.44 9.78 512 82416 142170 29349429
Hiccups 14.39 9.78 56 82872 8797 29482802
Mast cell activation syndrome 14.37 9.78 8 82920 178 29491421
Arthropathy 14.28 9.78 24 82904 21530 29470069
Magnetic resonance imaging spinal abnormal 14.16 9.78 6 82922 71 29491528
Torsade de pointes 14.14 9.78 46 82882 6615 29484984
Psychotic disorder 14.11 9.78 22 82906 20332 29471267
Musculoskeletal stiffness 13.83 9.78 56 82872 37402 29454197
Visual evoked potentials abnormal 13.80 9.78 6 82922 76 29491523
Hepatocellular injury 13.76 9.78 24 82904 21219 29470380
Blood pressure decreased 13.71 9.78 191 82737 45286 29446313
Respiratory failure 13.69 9.78 363 82565 96768 29394831
Stomatitis 13.34 9.78 161 82767 36952 29454647
Drug dependence 13.32 9.78 24 82904 20957 29470642
Protein total decreased 13.32 9.78 35 82893 4467 29487132
Product use issue 13.28 9.78 87 82841 51357 29440242
Burkholderia infection 13.20 9.78 6 82922 85 29491514
Polyneuropathy 13.10 9.78 9 82919 12143 29479456
Pneumonia staphylococcal 13.08 9.78 26 82902 2759 29488840
Convulsive threshold lowered 13.01 9.78 11 82917 492 29491107
Accidental exposure to product 12.93 9.78 7 82921 10746 29480853
Supine hypertension 12.85 9.78 9 82919 303 29491296
Convulsions local 12.75 9.78 4 82924 18 29491581
Rash maculo-papular 12.72 9.78 31 82897 24258 29467341
Inappropriate schedule of product administration 12.63 9.78 73 82855 44399 29447200
Sputum retention 12.49 9.78 10 82918 414 29491185
Central nervous system inflammation 12.27 9.78 6 82922 101 29491498
Cardiogenic shock 12.14 9.78 22 82906 19168 29472431
Anal erosion 12.09 9.78 4 82924 22 29491577
Cerebral microangiopathy 12.02 9.78 7 82921 170 29491429
Aggression 11.98 9.78 55 82873 35486 29456113
White blood cell count increased 11.89 9.78 159 82769 37357 29454242
Amino acid level decreased 11.74 9.78 5 82923 60 29491539
Amino acid level increased 11.63 9.78 9 82919 354 29491245
Hyperuricaemia 11.54 9.78 44 82884 6845 29484754
Progressive multifocal leukoencephalopathy 11.52 9.78 5 82923 8714 29482885
Post procedural haematoma 11.47 9.78 17 82911 1424 29490175
Jaundice hepatocellular 11.45 9.78 5 82923 64 29491535
Hypoalbuminaemia 11.31 9.78 58 82870 10247 29481352
Metabolic encephalopathy 11.25 9.78 29 82899 3658 29487941
Stevens-Johnson syndrome 11.21 9.78 82 82846 16415 29475184
Gastrointestinal tract mucosal pigmentation 11.21 9.78 9 82919 374 29491225
Hypertensive crisis 11.19 9.78 4 82924 7844 29483755
Granulocyte count decreased 10.97 9.78 11 82917 613 29490986
Conduction disorder 10.93 9.78 19 82909 1821 29489778
Saccadic eye movement 10.92 9.78 6 82922 130 29491469
Viral rash 10.87 9.78 5 82923 73 29491526
Hepatitis fulminant 10.81 9.78 28 82900 3543 29488056
Suicide attempt 10.79 9.78 54 82874 34056 29457543
Blood pressure fluctuation 10.72 9.78 25 82903 19869 29471730
Acute kidney injury 10.66 9.78 622 82306 264645 29226954
Pulmonary fibrosis 10.65 9.78 17 82911 15565 29476034
Ventricular flutter 10.57 9.78 5 82923 78 29491521
Coma 10.55 9.78 66 82862 39384 29452215
Gamma-glutamyltransferase increased 10.51 9.78 118 82810 26619 29464980
Substance abuse 10.49 9.78 3 82925 6784 29484815
Arthralgia 10.39 9.78 305 82623 139312 29352287
Respiratory symptom 10.32 9.78 13 82915 933 29490666
Sputum culture positive 10.29 9.78 18 82910 1734 29489865
Haematotoxicity 10.28 9.78 3 82925 6696 29484903
Ejaculation delayed 10.15 9.78 7 82921 230 29491369
Blood pH decreased 10.13 9.78 20 82908 2113 29489486
Flushing 10.09 9.78 125 82803 28867 29462732
Loss of personal independence in daily activities 10.05 9.78 37 82891 25403 29466196
Tunnel vision 10.03 9.78 9 82919 436 29491163
Retroperitoneal abscess 9.91 9.78 6 82922 157 29491442
Injection site pain 9.90 9.78 52 82876 32394 29459205
Granulocytopenia 9.81 9.78 38 82890 5956 29485643

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
Drug ineffective 403.80 9.32 950 160696 839297 63497789
Hepatic function abnormal 249.49 9.32 519 161127 63794 64273292
Drug abuse 207.40 9.32 40 161606 132334 64204752
Drug intolerance 202.99 9.32 109 161537 187883 64149203
Platelet count decreased 189.00 9.32 877 160769 166834 64170252
Synovitis 188.63 9.32 16 161630 99074 64238012
Contraindicated product administered 188.32 9.32 24 161622 107805 64229281
Joint swelling 173.80 9.32 170 161476 215212 64121874
Off label use 169.08 9.32 915 160731 631891 63705195
Toxicity to various agents 165.79 9.32 421 161225 363092 63973994
Rheumatoid arthritis 150.34 9.32 115 161531 164179 64172907
Aspartate aminotransferase increased 148.85 9.32 645 161001 119143 64217943
Arthropathy 146.15 9.32 60 161586 120907 64216179
Alanine aminotransferase increased 139.26 9.32 703 160943 138328 64198758
Pemphigus 137.42 9.32 3 161643 60698 64276388
White blood cell count decreased 135.55 9.32 765 160881 157072 64180014
Liver disorder 133.42 9.32 363 161283 52988 64284098
Treatment failure 125.65 9.32 68 161578 116748 64220338
Disseminated intravascular coagulation 121.84 9.32 258 161388 32090 64304996
Hand deformity 119.83 9.32 10 161636 62761 64274325
Therapeutic product effect decreased 118.55 9.32 71 161575 115280 64221806
Completed suicide 111.66 9.32 248 161398 224166 64112920
Pneumonia aspiration 108.25 9.32 361 161285 58910 64278176
Cytokine release syndrome 107.72 9.32 190 161456 20639 64316447
General physical health deterioration 107.47 9.32 219 161427 204206 64132880
Lower respiratory tract infection 93.40 9.32 61 161585 94553 64242533
Gastrooesophageal reflux disease 87.16 9.32 426 161220 82717 64254369
Neutrophil count decreased 85.60 9.32 402 161244 76794 64260292
Blood lactate dehydrogenase increased 84.63 9.32 227 161419 32851 64304235
Arthralgia 82.65 9.32 710 160936 441550 63895536
Type I hypersensitivity 78.81 9.32 68 161578 3506 64333580
Glossodynia 76.66 9.32 33 161613 64663 64272423
Interstitial lung disease 74.36 9.32 459 161187 97273 64239813
Systemic lupus erythematosus 72.66 9.32 53 161593 77559 64259527
Chronic kidney disease 68.19 9.32 307 161339 57612 64279474
Pericarditis 67.78 9.32 36 161610 62480 64274606
Upper respiratory tract inflammation 67.72 9.32 64 161582 3718 64333368
Cerebral infarction 65.41 9.32 239 161407 40805 64296281
Therapeutic product effect incomplete 63.18 9.32 101 161545 103381 64233705
Duodenal ulcer perforation 62.17 9.32 7 161639 34618 64302468
Flushing 61.48 9.32 372 161274 78276 64258810
Musculoskeletal stiffness 61.36 9.32 136 161510 123070 64214016
Helicobacter infection 61.32 9.32 11 161635 38351 64298735
Sopor 58.66 9.32 4 161642 29657 64307429
Lymphocyte stimulation test positive 56.53 9.32 35 161611 1071 64336015
Wound 56.43 9.32 65 161581 76412 64260674
Drug resistance 56.25 9.32 10 161636 35092 64301994
Product use issue 54.45 9.32 196 161450 151519 64185567
Sleep disorder due to general medical condition, insomnia type 53.58 9.32 3 161643 26267 64310819
Overdose 52.84 9.32 213 161433 159353 64177733
Blood alkaline phosphatase increased 52.42 9.32 279 161367 56000 64281086
Acute respiratory failure 51.71 9.32 255 161391 49679 64287407
Enterocolitis 51.34 9.32 101 161545 11917 64325169
Mobility decreased 51.25 9.32 85 161561 85755 64251331
Drug hypersensitivity 49.29 9.32 371 161275 237444 64099642
Decreased appetite 48.68 9.32 982 160664 280307 64056779
Discomfort 48.37 9.32 80 161566 80798 64256288
Muscle injury 48.35 9.32 5 161641 26432 64310654
Pneumonia 47.97 9.32 1783 159863 557793 63779293
Red blood cell sedimentation rate increased 47.72 9.32 10 161636 31225 64305861
Pyrexia 47.64 9.32 1779 159867 556865 63780221
Cholecystitis chronic 47.10 9.32 84 161562 9203 64327883
Maternal exposure during pregnancy 45.98 9.32 108 161538 95776 64241310
Drug interaction 45.98 9.32 635 161011 361448 63975638
Febrile neutropenia 44.94 9.32 690 160956 186967 64150119
Infective pulmonary exacerbation of cystic fibrosis 44.31 9.32 94 161552 11702 64325384
Blood bilirubin increased 44.19 9.32 271 161375 57282 64279804
Hypoxia 43.89 9.32 374 161272 87775 64249311
Folliculitis 43.22 9.32 11 161635 30066 64307020
Hepatocellular injury 42.19 9.32 31 161615 45204 64291882
Alopecia 42.14 9.32 243 161403 165447 64171639
Butterfly rash 40.12 9.32 29 161617 1153 64335933
Anaphylactic reaction 39.43 9.32 301 161345 68363 64268723
Urticaria 39.32 9.32 552 161094 146765 64190321
Torsade de pointes 38.36 9.32 113 161533 17250 64319836
Blood pressure fluctuation 37.28 9.32 45 161601 51826 64285260
Dehydration 36.57 9.32 754 160892 216009 64121077
Erythema multiforme 36.44 9.32 104 161542 15597 64321489
Plasma cell myeloma 36.04 9.32 218 161428 45857 64291229
Psoriatic arthropathy 35.04 9.32 34 161612 43247 64293839
Sepsis 34.93 9.32 789 160857 229552 64107534
Aplastic anaemia 34.07 9.32 94 161552 13826 64323260
Weight increased 33.98 9.32 356 161290 212992 64124094
Blood creatine phosphokinase MB increased 33.53 9.32 37 161609 2584 64334502
Hepatic enzyme increased 33.34 9.32 190 161456 129753 64207333
Intentional product use issue 33.02 9.32 125 161521 95239 64241847
Protein total decreased 31.87 9.32 65 161581 7871 64329215
Irritable bowel syndrome 31.86 9.32 28 161618 37341 64299745
Chest discomfort 31.76 9.32 437 161209 115669 64221417
Pneumonia bacterial 31.47 9.32 96 161550 14939 64322147
Haematocrit decreased 31.05 9.32 239 161407 54416 64282670
Drug eruption 30.86 9.32 175 161471 35961 64301125
Blood urea increased 30.86 9.32 203 161443 43950 64293136
Pneumonitis 30.74 9.32 224 161422 50141 64286945
Pain 30.22 9.32 1109 160537 552402 63784684
Knee arthroplasty 30.08 9.32 15 161631 26984 64310102
Blood albumin decreased 29.69 9.32 118 161528 20955 64316131
Impaired healing 29.08 9.32 68 161578 60405 64276681
Ill-defined disorder 28.80 9.32 41 161605 44011 64293075
Swelling 28.60 9.32 260 161386 159958 64177128
Mental status changes 28.10 9.32 255 161391 60907 64276179
Ventricular tachycardia 28.00 9.32 164 161482 34101 64302985
Injection site pain 27.99 9.32 164 161482 111244 64225842
White blood cell count increased 27.72 9.32 270 161376 65744 64271342
Lactic acidosis 27.23 9.32 72 161574 61338 64275748
Renal impairment 26.26 9.32 480 161166 134537 64202549
Angioedema 26.03 9.32 253 161393 61568 64275518
Blood pressure systolic increased 25.93 9.32 53 161593 49400 64287686
End stage renal disease 25.90 9.32 71 161575 10404 64326682
Fibromyalgia 25.68 9.32 31 161615 35700 64301386
Loss of personal independence in daily activities 25.06 9.32 95 161551 72359 64264727
Chills 24.97 9.32 483 161163 136781 64200305
Arthritis 24.61 9.32 117 161529 83697 64253389
Gastrointestinal disorder 24.19 9.32 129 161517 89580 64247506
Granulocytopenia 24.08 9.32 69 161577 10371 64326715
Periorbital oedema 23.27 9.32 55 161591 7359 64329727
Haemorrhage subcutaneous 22.83 9.32 40 161606 4321 64332765
Pain in extremity 22.70 9.32 582 161064 302503 64034583
Product use in unapproved indication 22.64 9.32 309 161337 176309 64160777
Intentional product misuse 22.37 9.32 99 161547 72196 64264890
Constipation 22.35 9.32 742 160904 228595 64108491
Polyneuropathy 22.24 9.32 11 161635 19883 64317203
Hyperuricaemia 22.21 9.32 66 161580 10125 64326961
Burkholderia test positive 21.49 9.32 15 161631 564 64336522
Peripheral swelling 21.37 9.32 382 161264 208771 64128315
Respiratory failure 21.34 9.32 542 161104 160641 64176445
Asteatosis 21.31 9.32 8 161638 76 64337010
Lip swelling 21.27 9.32 145 161501 31762 64305324
Hepatotoxicity 20.81 9.32 43 161603 39919 64297167
Blood pressure diastolic abnormal 19.97 9.32 3 161643 11914 64325172
Gallbladder disorder 19.83 9.32 90 161556 16940 64320146
Tenosynovitis 19.79 9.32 3 161643 11830 64325256
Haemoglobin decreased 19.75 9.32 634 161012 194429 64142657
Swelling face 19.27 9.32 230 161416 58936 64278150
Exposure during pregnancy 19.16 9.32 115 161531 77560 64259526
Medication error 18.96 9.32 63 161583 49903 64287183
Nasopharyngitis 18.82 9.32 362 161284 195711 64141375
Cholecystitis acute 18.82 9.32 67 161579 11293 64325793
Intentional overdose 18.76 9.32 140 161506 89804 64247282
Urinary tract infection 18.57 9.32 733 160913 230863 64106223
Biliary dyskinesia 18.31 9.32 26 161620 2346 64334740
Palmar erythema 18.27 9.32 22 161624 1688 64335398
Cholestasis 18.13 9.32 55 161591 44817 64292269
Small intestinal obstruction 17.46 9.32 110 161536 23463 64313623
Blood magnesium decreased 17.34 9.32 75 161571 13830 64323256
Hospice care 17.20 9.32 50 161596 7575 64329511
Abdominal discomfort 17.07 9.32 338 161308 181984 64155102
Hip arthroplasty 17.02 9.32 17 161629 21334 64315752
Basophil count decreased 17.00 9.32 9 161637 203 64336883
Tubulointerstitial nephritis 16.91 9.32 134 161512 30775 64306311
Stevens-Johnson syndrome 16.87 9.32 145 161501 34104 64302982
Non-cardiac chest pain 16.85 9.32 54 161592 8626 64328460
Blood pressure ambulatory increased 16.67 9.32 6 161640 50 64337036
Disease progression 16.63 9.32 469 161177 141211 64195875
Pleural effusion 16.58 9.32 425 161221 126134 64210952
Deep vein thrombosis 16.46 9.32 362 161284 104820 64232266
Therapeutic response decreased 16.43 9.32 71 161575 52117 64284969
Balance disorder 16.39 9.32 133 161513 83793 64253293
Blood potassium decreased 16.36 9.32 164 161482 40235 64296851
Inappropriate schedule of product administration 16.35 9.32 150 161496 92136 64244950
Ventricular flutter 16.29 9.32 7 161639 97 64336989
Extrapyramidal disorder 16.25 9.32 15 161631 19537 64317549
Throat irritation 15.86 9.32 138 161508 32573 64304513
Injection site bruising 15.86 9.32 43 161603 36330 64300756
Heart rate decreased 15.51 9.32 78 161568 54989 64282097
Therapy non-responder 15.50 9.32 99 161547 65800 64271286
Basal cell carcinoma 15.37 9.32 34 161612 30804 64306282
Chest pain 15.37 9.32 731 160915 235249 64101837
Blister 15.05 9.32 130 161516 80837 64256249
Psychotic disorder 14.98 9.32 41 161605 34537 64302549
Glossectomy 14.98 9.32 3 161643 0 64337086
Emotional distress 14.93 9.32 147 161499 35891 64301195
Musculoskeletal pain 14.90 9.32 131 161515 81163 64255923
Renal injury 14.71 9.32 77 161569 15352 64321734
Throat tightness 14.70 9.32 104 161542 23056 64314030
Hypoalbuminaemia 14.70 9.32 85 161561 17589 64319497
Cholangitis acute 14.69 9.32 17 161629 1251 64335835
Neuroleptic malignant syndrome 14.68 9.32 25 161621 24971 64312115
Autoimmune hepatitis 14.64 9.32 57 161589 10027 64327059
Gastrointestinal mucosal necrosis 14.63 9.32 8 161638 193 64336893
Haematotoxicity 14.61 9.32 7 161639 12889 64324197
Congenital neuropathy 14.45 9.32 4 161642 12 64337074
Contusion 14.37 9.32 200 161446 113765 64223321
Gallbladder injury 14.33 9.32 16 161630 1132 64335954
Drug dependence 14.06 9.32 40 161606 33272 64303814
Pulmonary fibrosis 14.04 9.32 34 161612 29844 64307242
Hypertensive crisis 14.01 9.32 15 161631 18233 64318853
Red blood cell count decreased 14.00 9.32 184 161462 48202 64288884
Blood creatinine increased 13.91 9.32 442 161204 135340 64201746
Circulatory collapse 13.88 9.32 41 161605 33691 64303395
Anaplastic astrocytoma 13.80 9.32 7 161639 144 64336942
Dermatitis atopic 13.54 9.32 30 161616 3846 64333240
Brain natriuretic peptide increased 13.49 9.32 46 161600 7587 64329499
Impaired work ability 13.47 9.32 11 161635 15208 64321878
Gamma-glutamyltransferase increased 13.43 9.32 183 161463 48327 64288759
Ventricular fibrillation 13.36 9.32 104 161542 23756 64313330
Post procedural haematoma 13.25 9.32 22 161624 2276 64334810
Therapy cessation 13.21 9.32 132 161514 32357 64304729
Suicide attempt 13.20 9.32 114 161532 70893 64266193
Fibrin D dimer increased 13.06 9.32 42 161604 6723 64330363
Cardiac autonomic neuropathy 13.01 9.32 5 161641 51 64337035
Status asthmaticus 12.97 9.32 14 161632 954 64336132
Administration site inflammation 12.90 9.32 3 161643 3 64337083
Acquired haemophilia 12.87 9.32 18 161628 1602 64335484
Haemodialysis 12.85 9.32 80 161566 16997 64320089
Osteoporosis 12.79 9.32 58 161588 42022 64295064
Toxic epidermal necrolysis 12.77 9.32 146 161500 37020 64300066
Milk allergy 12.76 9.32 6 161640 104 64336982
Breast adenoma 12.75 9.32 5 161641 54 64337032
Sedation complication 12.72 9.32 5 161641 10349 64326737
Anaphylactoid reaction 12.61 9.32 33 161613 4705 64332381
Condition aggravated 12.54 9.32 785 160861 371641 63965445
Hypervolaemia 12.54 9.32 149 161497 38136 64298950
Therapy partial responder 12.50 9.32 5 161641 10243 64326843
Pathogen resistance 12.49 9.32 8 161638 12535 64324551
Hereditary angioedema 12.43 9.32 29 161617 3847 64333239
Sputum culture positive 12.41 9.32 25 161621 3001 64334085
Accidental exposure to product 12.39 9.32 30 161616 26334 64310752
Musculoskeletal disorder 12.38 9.32 16 161630 17890 64319196
Blood pressure decreased 12.34 9.32 293 161353 85906 64251180
Cholelithiasis 12.32 9.32 171 161475 45335 64291751
Ileus 12.25 9.32 99 161547 22867 64314219
Catheter site haemorrhage 12.24 9.32 32 161614 4559 64332527
Intentional self-injury 12.17 9.32 35 161611 29009 64308077
Iron deficiency anaemia 12.03 9.32 95 161551 21794 64315292
Injury 11.93 9.32 202 161444 55790 64281296
Rash 11.92 9.32 1318 160328 457231 63879855
Coronary artery dissection 11.91 9.32 13 161633 897 64336189
Blood pressure systolic abnormal 11.89 9.32 5 161641 9937 64327149
Swollen tongue 11.87 9.32 137 161509 34817 64302269
Joint stiffness 11.76 9.32 38 161608 30366 64306720
Victim of chemical submission 11.67 9.32 8 161638 292 64336794
Diarrhoea 11.62 9.32 2019 159627 720685 63616401
Device difficult to use 11.60 9.32 5 161641 9793 64327293
Poisoning deliberate 11.57 9.32 10 161636 13448 64323638
Heparin-induced thrombocytopenia 11.56 9.32 47 161599 8432 64328654
Injection site reaction 11.55 9.32 69 161577 46595 64290491
Cystitis noninfective 11.45 9.32 14 161632 1092 64335994
Granulocyte count decreased 11.38 9.32 15 161631 1261 64335825
Cystic fibrosis 11.35 9.32 26 161620 3408 64333678
Platelet transfusion 11.34 9.32 18 161628 1793 64335293
Infection 11.30 9.32 365 161281 184515 64152571
Foot deformity 11.15 9.32 15 161631 16489 64320597
Allergy test positive 11.07 9.32 9 161637 427 64336659
Tinea pedis 10.91 9.32 19 161627 2042 64335044
Injection site erythema 10.91 9.32 119 161527 70681 64266405
Nausea 10.82 9.32 2178 159468 783622 63553464
Hypophagia 10.82 9.32 149 161497 39438 64297648
Putamen haemorrhage 10.80 9.32 9 161637 442 64336644
Ischaemic stroke 10.75 9.32 37 161609 28998 64308088
Urine osmolarity decreased 10.72 9.32 5 161641 85 64337001
Lymphopenia 10.69 9.32 31 161615 25626 64311460
Cancer pain 10.67 9.32 29 161617 4228 64332858
Substance abuse 10.60 9.32 5 161641 9287 64327799
Wound secretion 10.57 9.32 33 161613 5199 64331887
Catatonia 10.55 9.32 3 161643 7617 64329469
Pneumothorax 10.50 9.32 100 161546 24198 64312888
Hepatitis cholestatic 10.49 9.32 9 161637 12146 64324940
Post procedural haemorrhage 10.48 9.32 60 161586 12371 64324715
Lymphocyte percentage increased 10.48 9.32 10 161636 588 64336498
Hypoparathyroidism 10.46 9.32 12 161634 875 64336211
Amylase increased 10.41 9.32 50 161596 9635 64327451
Reversible cerebral vasoconstriction syndrome 10.39 9.32 20 161626 2322 64334764
Anal erosion 10.39 9.32 4 161642 41 64337045
Supine hypertension 10.34 9.32 8 161638 353 64336733
Peritonitis 10.33 9.32 102 161544 24921 64312165
Palmar-plantar erythrodysaesthesia syndrome 10.26 9.32 114 161532 28705 64308381
Hyperlipidaemia 10.15 9.32 95 161551 22881 64314205
Restless arm syndrome 10.14 9.32 4 161642 44 64337042
Dermatitis acneiform 10.12 9.32 45 161601 8398 64328688
Hypokalaemia 10.03 9.32 387 161259 121516 64215570
Cognitive disorder 9.99 9.32 89 161557 54998 64282088
Hypersomnia 9.99 9.32 84 161562 19633 64317453
Pityriasis lichenoides et varioliformis acuta 9.98 9.32 4 161642 46 64337040
Tumour lysis syndrome 9.94 9.32 83 161563 19357 64317729
Laboratory test abnormal 9.89 9.32 98 161548 23965 64313121
Human ehrlichiosis 9.89 9.32 8 161638 377 64336709
Lymphocyte count decreased 9.86 9.32 150 161496 40549 64296537
VIIth nerve injury 9.86 9.32 6 161640 178 64336908
Convulsions local 9.83 9.32 4 161642 48 64337038
Stoma site cellulitis 9.81 9.32 3 161643 14 64337072
Metabolic encephalopathy 9.79 9.32 43 161603 7982 64329104
Nephrogenic anaemia 9.72 9.32 24 161622 3301 64333785
Therapeutic hypothermia 9.64 9.32 3 161643 15 64337071
PCO2 decreased 9.63 9.32 22 161624 2880 64334206
Malignant melanoma 9.58 9.32 11 161635 12953 64324133
PO2 increased 9.58 9.32 15 161631 1477 64335609
Vertigo 9.57 9.32 98 161548 58913 64278173
Gastritis 9.54 9.32 155 161491 42463 64294623
Mean arterial pressure increased 9.47 9.32 4 161642 53 64337033
Abdominal distension 9.44 9.32 311 161335 95683 64241403
Malnutrition 9.43 9.32 81 161565 19044 64318042
Bronchial hyperreactivity 9.41 9.32 20 161626 2492 64334594
Eosinophil count increased 9.33 9.32 64 161582 14048 64323038
Hypergeusia 9.33 9.32 3 161643 17 64337069

FDA Adverse Event Reporting System (Pediatric)

None

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 antagonists
CHEBI has role CHEBI:49201 anti-ulcer drugs
CHEBI has role CHEBI:50183 P450 inhibitors
FDA EPC N0000175784 Histamine-2 Receptor Antagonist
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

Drug Use | Suggest Off label Use Form| |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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

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
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 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 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
acid controller HUMAN OTC DRUG LABEL 1 0363-1203 TABLET, FILM COATED 20 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