famotidine 🐶 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 µM/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
S (Water solubility) 1 mg/mL Bocci G, Oprea TI, Benet LZ

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 440.09 9.41 1044 139050 1043721 62305207
Pemphigus 388.27 9.41 3 140091 183723 63165205
Contraindicated product administered 388.11 9.41 23 140071 217625 63131303
Synovitis 377.51 9.41 7 140087 186911 63162017
Drug intolerance 320.65 9.41 140 139954 308521 63040407
Hand deformity 310.28 9.41 9 140085 159448 63189480
Systemic lupus erythematosus 289.65 9.41 55 140039 208863 63140065
Glossodynia 282.78 9.41 32 140062 178844 63170084
Joint swelling 269.57 9.41 198 139896 327468 63021460
Arthropathy 264.29 9.41 94 140000 234698 63114230
Treatment failure 260.28 9.41 60 140034 198983 63149945
Therapeutic product effect decreased 245.22 9.41 62 140032 193125 63155803
Pericarditis 214.44 9.41 21 140073 131558 63217370
Rheumatoid arthritis 195.21 9.41 164 139930 253655 63095273
Wound 191.24 9.41 61 140033 163202 63185726
Duodenal ulcer perforation 169.31 9.41 5 140089 87204 63261724
Helicobacter infection 161.71 9.41 11 140083 92774 63256154
Lower respiratory tract infection 140.41 9.41 58 140036 132249 63216679
Hepatic enzyme increased 136.47 9.41 147 139947 202181 63146747
Hepatic function abnormal 135.18 9.41 271 139823 36871 63312057
Alopecia 134.10 9.41 346 139748 337190 63011738
Pneumonia aspiration 132.94 9.41 258 139836 34282 63314646
Maternal exposure during pregnancy 131.31 9.41 176 139918 219886 63129042
Gastrooesophageal reflux disease 128.22 9.41 483 139611 95156 63253772
Platelet count decreased 127.42 9.41 551 139543 115571 63233357
White blood cell count decreased 126.73 9.41 625 139469 138479 63210449
Muscle injury 125.92 9.41 4 140090 65341 63283587
General physical health deterioration 125.39 9.41 156 139938 201246 63147682
Swelling 122.32 9.41 266 139828 275112 63073816
Product use issue 116.36 9.41 192 139902 220328 63128600
Folliculitis 115.12 9.41 11 140083 70306 63278622
Musculoskeletal stiffness 109.76 9.41 148 139946 184470 63164458
Discomfort 108.04 9.41 126 139968 167248 63181680
Chronic kidney disease 100.98 9.41 273 139821 45125 63303803
Abdominal discomfort 96.39 9.41 373 139721 320512 63028416
Drug abuse 94.43 9.41 22 140072 72496 63276432
Toxicity to various agents 93.91 9.41 259 139835 246991 63101937
Off label use 92.32 9.41 998 139096 673464 62675464
Mobility decreased 86.22 9.41 84 140010 121075 63227853
C-reactive protein abnormal 84.81 9.41 4 140090 46092 63302836
Flushing 83.64 9.41 358 139736 74729 63274199
Aspartate aminotransferase increased 82.44 9.41 406 139688 89871 63259057
Psoriatic arthropathy 78.13 9.41 53 140041 91467 63257461
Therapeutic product effect incomplete 75.58 9.41 99 139995 124957 63223971
Disseminated intravascular coagulation 75.37 9.41 144 139950 18907 63330021
Anaphylactic reaction 69.68 9.41 310 139784 65790 63283138
Liver injury 68.39 9.41 24 140070 60496 63288432
Arthralgia 68.17 9.41 868 139226 568842 62780086
Neutrophil count decreased 65.97 9.41 273 139821 56133 63292795
Impaired healing 65.28 9.41 78 140016 102464 63246464
Dehydration 65.08 9.41 626 139468 172728 63176200
Ill-defined disorder 62.54 9.41 53 140041 81702 63267226
Chest discomfort 61.70 9.41 435 139659 109534 63239394
Drug hypersensitivity 60.51 9.41 419 139675 310268 63038660
Pain 60.01 9.41 1214 138880 739414 62609514
Alanine aminotransferase increased 59.70 9.41 413 139681 103357 63245571
Mast cell activation syndrome 58.71 9.41 31 140063 794 63348134
Urinary tract infection 54.79 9.41 854 139240 263830 63085098
Irritable bowel syndrome 54.27 9.41 61 140033 82351 63266577
Cholecystitis chronic 53.49 9.41 88 140006 10273 63338655
Blister 53.04 9.41 131 139963 129683 63219245
Knee arthroplasty 52.45 9.41 27 140067 54179 63294749
Blood lactate dehydrogenase increased 52.39 9.41 140 139954 22976 63325952
Fibromyalgia 51.36 9.41 61 140033 80359 63268569
Diarrhoea 49.88 9.41 1989 138105 713377 62635551
Interstitial lung disease 49.27 9.41 268 139826 61640 63287288
Febrile neutropenia 49.10 9.41 437 139657 118012 63230916
Red blood cell sedimentation rate increased 48.75 9.41 18 140076 43964 63304964
COVID-19 48.29 9.41 420 139674 112683 63236245
Hip arthroplasty 47.21 9.41 23 140071 47623 63301305
Angioedema 45.41 9.41 218 139876 47747 63301181
Intentional product use issue 43.44 9.41 141 139953 127751 63221177
Lip swelling 41.69 9.41 157 139937 30906 63318022
Nausea 40.59 9.41 2287 137807 852184 62496744
Upper respiratory tract inflammation 40.56 9.41 38 140056 2485 63346443
Mental status changes 40.43 9.41 184 139910 39415 63309513
Constipation 39.61 9.41 707 139387 224236 63124692
Dermatitis atopic 39.08 9.41 74 140020 9650 63339278
Hepatocellular injury 38.34 9.41 7 140087 27374 63321554
Loss of personal independence in daily activities 38.33 9.41 100 139994 97190 63251738
Enterocolitis 38.24 9.41 65 140029 7793 63341135
Type 2 diabetes mellitus 38.12 9.41 51 140043 63817 63285111
Decreased appetite 38.02 9.41 771 139323 250281 63098647
Throat tightness 37.83 9.41 131 139963 24756 63324172
Cerebral infarction 36.52 9.41 126 139968 23767 63325161
Butterfly rash 35.03 9.41 30 140064 1743 63347185
Sopor 34.90 9.41 4 140090 22160 63326768
Illness 34.83 9.41 206 139888 48853 63300075
Urticaria 34.66 9.41 536 139558 165266 63183662
Gastrointestinal disorder 34.13 9.41 161 139933 131078 63217850
Blood cholesterol increased 33.81 9.41 101 139993 93931 63254997
Exposure during pregnancy 33.69 9.41 203 139891 155344 63193584
Somnolence 32.29 9.41 564 139530 178121 63170807
Plasma cell myeloma 31.71 9.41 160 139934 35745 63313183
Torsade de pointes 31.41 9.41 82 140012 13269 63335659
Acute respiratory failure 30.68 9.41 154 139940 34331 63314597
Infective pulmonary exacerbation of cystic fibrosis 30.49 9.41 63 140031 8754 63340174
Neuropathy peripheral 30.43 9.41 384 139710 113283 63235645
Periorbital oedema 30.32 9.41 49 140045 5635 63343293
Gallbladder disorder 30.24 9.41 101 139993 18741 63330187
Medication error 29.95 9.41 43 140051 52241 63296687
Therapy non-responder 29.91 9.41 78 140016 75823 63273105
Arthritis 28.53 9.41 145 139949 115776 63233152
Hereditary angioedema 28.50 9.41 56 140038 7506 63341422
Haemorrhage subcutaneous 28.41 9.41 34 140060 2949 63345979
Throat irritation 27.97 9.41 160 139934 37487 63311441
Drug tolerance decreased 27.90 9.41 3 140091 17470 63331458
Musculoskeletal pain 27.81 9.41 107 139987 92170 63256758
Dizziness 27.68 9.41 1186 138908 428739 62920189
Condition aggravated 27.65 9.41 676 139418 401541 62947387
Completed suicide 27.56 9.41 198 139896 145475 63203453
Rheumatoid nodule 27.25 9.41 3 140091 17152 63331776
Pneumonia 27.21 9.41 1250 138844 455517 62893411
Osteoarthritis 27.18 9.41 113 139981 95230 63253698
Product dose omission issue 27.14 9.41 693 139401 233620 63115308
Hypoxia 27.07 9.41 225 139869 59567 63289361
Inflammation 27.04 9.41 92 140002 82181 63266747
Weight fluctuation 26.99 9.41 64 140030 9755 63339173
Contusion 26.92 9.41 207 139887 149837 63199091
Gastritis 26.71 9.41 157 139937 37146 63311782
Sepsis 26.48 9.41 480 139614 152643 63196285
Liver disorder 25.91 9.41 205 139889 53482 63295446
Aplastic anaemia 25.91 9.41 62 140032 9507 63339421
Blood alkaline phosphatase increased 25.88 9.41 173 139921 42794 63306134
Emotional distress 25.28 9.41 140 139954 32409 63316519
Seasonal allergy 24.96 9.41 102 139992 20848 63328080
Pulmonary fibrosis 24.57 9.41 31 140063 39778 63309150
Overdose 24.48 9.41 151 139943 114927 63234001
Dyspnoea 24.48 9.41 1733 138361 659580 62689348
Infection 24.47 9.41 357 139737 228816 63120112
Back pain 24.39 9.41 759 139335 263386 63085542
Blood magnesium decreased 24.14 9.41 74 140020 13124 63335804
Disease progression 23.81 9.41 392 139702 122366 63226562
Hepatotoxicity 23.75 9.41 28 140066 37013 63311915
Blood potassium decreased 23.41 9.41 166 139928 41860 63307068
Hospice care 23.23 9.41 53 140041 7879 63341049
Hypersensitivity 22.90 9.41 482 139612 292203 63056725
Cholecystitis acute 22.88 9.41 54 140040 8206 63340722
Drug resistance 22.82 9.41 11 140083 22922 63326006
Vaccination site reaction 22.37 9.41 9 140085 120 63348808
Anaemia 22.24 9.41 824 139270 292606 63056322
Renal injury 22.23 9.41 58 140036 9381 63339547
Lymphocyte stimulation test positive 22.19 9.41 14 140080 505 63348423
Cough 22.18 9.41 822 139272 291921 63057007
Abdominal distension 22.08 9.41 290 139804 86325 63262603
Ventricular tachycardia 22.03 9.41 95 139999 19884 63329044
Blood pressure diastolic abnormal 21.98 9.41 3 140091 14539 63334389
Prescribed overdose 21.70 9.41 26 140068 34127 63314801
Dopamine transporter scintigraphy abnormal 21.35 9.41 8 140086 87 63348841
Joint range of motion decreased 21.35 9.41 24 140070 32404 63316524
Hypervolaemia 21.27 9.41 121 139973 28292 63320636
End stage renal disease 21.03 9.41 46 140048 6647 63342281
Full blood count decreased 20.93 9.41 113 139981 25911 63323017
Pyrexia 20.63 9.41 1251 138843 469227 62879701
Coma 20.57 9.41 225 139869 64139 63284789
Tenosynovitis 20.49 9.41 3 140091 13792 63335136
Erythema multiforme 20.48 9.41 59 140035 10110 63338818
Blood pressure fluctuation 20.30 9.41 45 140049 46272 63302656
Blood bilirubin increased 20.28 9.41 146 139948 36994 63311934
Cystoid macular oedema 20.25 9.41 21 140073 1554 63347374
Drug eruption 20.05 9.41 120 139974 28574 63320354
Palmar erythema 19.97 9.41 22 140072 1745 63347183
Hypokalaemia 19.95 9.41 331 139763 103473 63245455
Cystitis noninfective 19.87 9.41 17 140077 986 63347942
Weight increased 19.66 9.41 432 139662 260360 63088568
Feeling abnormal 19.62 9.41 447 139647 147945 63200983
Foetal exposure during pregnancy 19.61 9.41 25 140069 31937 63316991
Hypoalbuminaemia 19.58 9.41 64 140030 11741 63337187
Biliary dyskinesia 19.54 9.41 27 140067 2702 63346226
White blood cell count increased 19.51 9.41 178 139916 48383 63300545
Chills 19.45 9.41 355 139739 113023 63235905
Peripheral swelling 19.35 9.41 443 139651 265499 63083429
Live birth 19.13 9.41 17 140077 25613 63323315
Total lung capacity abnormal 19.11 9.41 7 140087 71 63348857
Premature baby 19.08 9.41 11 140083 20724 63328204
Ileus 18.59 9.41 73 140021 14652 63334276
Swelling face 18.53 9.41 218 139876 63257 63285671
Laboratory test abnormal 18.46 9.41 112 139982 26800 63322128
Anaphylactoid reaction 18.39 9.41 31 140063 3692 63345236
Joint stiffness 18.09 9.41 41 140053 41828 63307100
Chest pain 17.72 9.41 612 139482 215347 63133581
Acquired haemophilia 17.49 9.41 16 140078 1015 63347913
Basophil count decreased 17.32 9.41 8 140086 152 63348776
Infusion related reaction 17.29 9.41 411 139683 245110 63103818
Bacteriuria 17.20 9.41 16 140078 1037 63347891
Rebound acid hypersecretion 16.93 9.41 10 140084 320 63348608
Respiratory alkalosis 16.81 9.41 25 140069 2676 63346252
Cytomegalovirus enterocolitis 16.55 9.41 13 140081 668 63348260
Asteatosis 16.55 9.41 6 140088 59 63348869
Device difficult to use 16.42 9.41 4 140090 12792 63336136
Therapeutic response decreased 16.27 9.41 75 140019 61450 63287478
Haematocrit decreased 16.21 9.41 145 139949 39195 63309733
Device expulsion 16.08 9.41 33 140061 34889 63314039
Lupus hepatitis 16.07 9.41 5 140089 29 63348899
Lip dry 16.05 9.41 7 140087 15463 63333465
Lymphocyte count decreased 15.98 9.41 118 139976 30139 63318789
Eye haematoma 15.95 9.41 6 140088 66 63348862
Hepatic cytolysis 15.94 9.41 7 140087 15400 63333528
Nasopharyngitis 15.93 9.41 433 139661 253824 63095104
Joint dislocation 15.89 9.41 11 140083 18789 63330139
Red blood cell count decreased 15.83 9.41 148 139946 40497 63308431
Heart rate increased 15.79 9.41 294 139800 93944 63254984
Panniculitis 15.75 9.41 3 140091 11382 63337546
Cytokine release syndrome 15.73 9.41 68 140026 14246 63334682
Gastrointestinal haemorrhage 15.65 9.41 259 139835 80917 63268011
Blood pressure systolic increased 15.57 9.41 53 140041 47344 63301584
Reflux gastritis 15.49 9.41 16 140078 1179 63347749
Protein total decreased 15.40 9.41 38 140056 5939 63342989
Vomiting 15.40 9.41 1434 138660 558183 62790745
Anxiety 15.31 9.41 606 139488 216935 63131993
Sleep disorder due to a general medical condition 15.27 9.41 4 140090 12184 63336744
Grip strength decreased 15.22 9.41 16 140078 22271 63326657
Facet joint syndrome 15.18 9.41 4 140090 12134 63336794
Blood urea increased 15.16 9.41 105 139989 26274 63322654
Impaired work ability 15.07 9.41 10 140084 17465 63331463
Small intestinal obstruction 15 9.41 80 140014 18257 63330671
Palpitations 15.00 9.41 340 139754 112430 63236498
Congenital neuropathy 14.96 9.41 4 140090 12 63348916
Gallbladder injury 14.85 9.41 17 140077 1406 63347522
Atrioventricular block complete 14.85 9.41 46 140048 8205 63340723
Infusion site erythema 14.82 9.41 58 140036 11621 63337307
Hyperuricaemia 14.76 9.41 35 140059 5335 63343593
Blood pressure decreased 14.65 9.41 213 139881 64809 63284119
Bursitis 14.64 9.41 38 140056 37003 63311925
Deep vein thrombosis 14.58 9.41 263 139831 83537 63265391
Infusion site swelling 14.48 9.41 51 140043 9719 63339209
Blindness transient 14.44 9.41 28 140066 3716 63345212
Amino acid level decreased 14.38 9.41 5 140089 43 63348885
Pulmonary hypertension 14.37 9.41 135 139959 36988 63311940
Carbohydrate antigen 15-3 14.34 9.41 6 140088 89 63348839
Carcinoembryonic antigen 14.16 9.41 6 140088 92 63348836
Oropharyngeal discomfort 14.15 9.41 34 140060 5226 63343702
Burkholderia test positive 14.10 9.41 8 140086 237 63348691
Macular degeneration 14.01 9.41 20 140074 24356 63324572
Breast cancer stage III 13.82 9.41 3 140091 10383 63338545
Pharyngeal swelling 13.72 9.41 38 140056 6366 63342562
Bone pain 13.53 9.41 182 139912 54459 63294469
Anhedonia 13.53 9.41 54 140040 10920 63338008
Granulocytopenia 13.51 9.41 35 140059 5637 63343291
Skin exfoliation 13.46 9.41 150 139944 42952 63305976
Infusion site pain 13.40 9.41 73 140021 16796 63332132
Breast adenoma 13.37 9.41 5 140089 54 63348874
Status asthmaticus 13.36 9.41 13 140081 891 63348037
Adverse drug reaction 13.35 9.41 112 139982 79602 63269326
Cholelithiasis 13.33 9.41 152 139942 43773 63305155
Sedation complication 13.20 9.41 7 140087 13815 63335113
Blood albumin decreased 13.18 9.41 66 140028 14700 63334228
Adverse event 13.17 9.41 91 140003 67468 63281460
Hyperlipidaemia 13.14 9.41 81 140013 19490 63329438
Haemoglobin decreased 13.13 9.41 417 139677 145068 63203860
Therapy interrupted 13.05 9.41 119 139975 32336 63316592
Pleural effusion 13.02 9.41 283 139811 92927 63256001
Rhinovirus infection 12.97 9.41 30 140064 4499 63344429
Intentional self-injury 12.94 9.41 23 140071 25664 63323264
Oropharyngeal spasm 12.90 9.41 8 140086 280 63348648
Respiratory failure 12.89 9.41 305 139789 101553 63247375
Cholinergic syndrome 12.83 9.41 10 140084 508 63348420
Head discomfort 12.71 9.41 61 140033 13354 63335574
Mite allergy 12.70 9.41 11 140083 649 63348279
Drug clearance decreased 12.66 9.41 16 140078 1468 63347460
Putamen haemorrhage 12.63 9.41 7 140087 198 63348730
Haemolytic anaemia 12.62 9.41 50 140044 10075 63338853
Feeling hot 12.58 9.41 168 139926 50186 63298742
Hypoparathyroidism 12.44 9.41 11 140083 667 63348261
Chronic spontaneous urticaria 12.38 9.41 14 140080 1143 63347785
Pyuria 12.32 9.41 18 140076 1896 63347032
Extrapyramidal disorder 12.29 9.41 7 140087 13277 63335651
Cranial nerve disorder 12.22 9.41 10 140084 545 63348383
Ovarian cancer recurrent 12.08 9.41 13 140081 1004 63347924
Dermatitis acneiform 12.08 9.41 31 140063 4965 63343963
Ammonia decreased 12.07 9.41 3 140091 6 63348922
Lethargy 12.05 9.41 182 139912 55825 63293103
Coronary artery dissection 12.01 9.41 12 140082 850 63348078
Urinary retention postoperative 11.96 9.41 5 140089 74 63348854
Creatinine renal clearance decreased 11.95 9.41 11 140083 16297 63332631
Spondylolisthesis 11.91 9.41 25 140069 3511 63345417
Poikiloderma 11.91 9.41 7 140087 222 63348706
Intentional product misuse 11.90 9.41 82 140012 60835 63288093
Haematotoxicity 11.90 9.41 3 140091 9373 63339555
Blood creatine phosphokinase MB increased 11.81 9.41 14 140080 1202 63347726
Xanthogranuloma 11.76 9.41 3 140091 7 63348921
Swollen tongue 11.75 9.41 123 139971 34677 63314251
Reversible cerebral vasoconstriction syndrome 11.65 9.41 21 140073 2637 63346291
COVID-19 pneumonia 11.63 9.41 62 140032 14147 63334781
Renal failure 11.63 9.41 341 139753 117311 63231617
Respiratory syncytial virus infection 11.60 9.41 38 140056 6980 63341948
Thrombosis 11.54 9.41 204 139890 64551 63284377
Foot deformity 11.45 9.41 28 140066 27825 63321103
Altered state of consciousness 11.45 9.41 95 139999 25135 63323793
Ovarian cancer 11.39 9.41 34 140060 5942 63342986
Dizziness postural 11.36 9.41 39 140055 7337 63341591
Pneumothorax 11.36 9.41 68 140026 16193 63332735
Dysgeusia 11.32 9.41 155 139939 46555 63302373
Osteoporosis 11.29 9.41 77 140017 57261 63291667
Pityriasis lichenoides et varioliformis acuta 11.25 9.41 4 140090 37 63348891
Brain natriuretic peptide increased 11.24 9.41 31 140063 5182 63343746
Dry skin 11.15 9.41 182 139912 56705 63292223
Blood pressure systolic abnormal 11.09 9.41 8 140086 13378 63335550
Asthma 11.09 9.41 364 139730 127197 63221731
Pleural neoplasm 11.06 9.41 8 140086 363 63348565
Infusion related hypersensitivity reaction 10.87 9.41 7 140087 262 63348666
Injection site reaction 10.84 9.41 80 140014 58444 63290484
Hypophagia 10.79 9.41 111 139983 31148 63317780
Atopy 10.77 9.41 7 140087 266 63348662
Vascular resistance systemic decreased 10.73 9.41 5 140089 97 63348831
Flashback 10.72 9.41 6 140088 173 63348755
Disability 10.59 9.41 15 140079 18332 63330596
Blindness cortical 10.58 9.41 9 140085 518 63348410
Drug dependence 10.55 9.41 24 140070 24459 63324469
Cellulitis 10.55 9.41 246 139848 81712 63267216
Muscle spasticity 10.55 9.41 20 140074 21774 63327154
Red blood cell schistocytes present 10.54 9.41 7 140087 276 63348652
Epistaxis 10.54 9.41 222 139872 72503 63276425
Heliotrope rash 10.48 9.41 6 140088 181 63348747
Pneumonia bacterial 10.43 9.41 45 140049 9420 63339508
Night sweats 10.40 9.41 64 140030 48750 63300178
Restless arm syndrome 10.40 9.41 4 140090 47 63348881
Enterovirus infection 10.39 9.41 12 140082 1002 63347926
Neurological examination abnormal 10.39 9.41 7 140087 283 63348645
Dyspepsia 10.31 9.41 297 139797 101899 63247029
Cholestasis 10.30 9.41 32 140062 29402 63319526
Ingrowing nail 10.29 9.41 19 140075 2430 63346498
Infusion site pruritus 10.27 9.41 33 140061 6002 63342926
Neuroleptic malignant syndrome 10.26 9.41 7 140087 12049 63336879
Allergic transfusion reaction 10.25 9.41 4 140090 49 63348879
Reticulocyte percentage increased 10.18 9.41 3 140091 14 63348914
Tremor 10.16 9.41 372 139722 131867 63217061
Device related infection 10.04 9.41 87 140007 23305 63325623
Mean arterial pressure increased 10.01 9.41 3 140091 15 63348913
Therapeutic hypothermia 10.01 9.41 3 140091 15 63348913
Dysphagia 9.94 9.41 261 139833 88324 63260604
Shock 9.93 9.41 87 140007 23376 63325552
Bacterial test positive 9.93 9.41 30 140064 5277 63343651
Polyarthritis 9.89 9.41 5 140089 10141 63338787
Oesophagogastric fundoplasty 9.88 9.41 5 140089 117 63348811
Myocarditis infectious 9.85 9.41 3 140091 16 63348912
Cerebrovascular accident 9.84 9.41 310 139784 107714 63241214
Renal impairment 9.83 9.41 260 139834 88095 63260833
Multiple allergies 9.82 9.41 58 140036 13744 63335184
Tinea pedis 9.82 9.41 14 140080 1442 63347486
Atelectasis 9.80 9.41 81 140013 21402 63327526
Hyperglycaemia 9.77 9.41 138 139956 41729 63307199
Stress cardiomyopathy 9.71 9.41 44 140050 9406 63339522
Intraductal papillary breast neoplasm 9.70 9.41 3 140091 17 63348911
Hypergeusia 9.70 9.41 3 140091 17 63348911
Colitis ischaemic 9.65 9.41 48 140046 10660 63338268
Benign vulval neoplasm 9.64 9.41 4 140090 58 63348870
Oropharyngeal swelling 9.61 9.41 11 140083 910 63348018
Diabetic retinal oedema 9.53 9.41 7 140087 325 63348603
Gastrostomy tube site complication 9.52 9.41 4 140090 60 63348868
Subarachnoid haemorrhage 9.51 9.41 59 140035 14224 63334704
Ear swelling 9.49 9.41 14 140080 1487 63347441
Anaplastic astrocytoma 9.46 9.41 4 140090 61 63348867
Injection site bruising 9.43 9.41 54 140040 41856 63307072
SARS-CoV-2 test positive 9.42 9.41 39 140055 8017 63340911
Pyelonephritis acute 9.42 9.41 27 140067 4614 63344314

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 182.09 10.01 609 91574 456142 34408606
Drug abuse 177.95 10.01 25 92158 99071 34765677
Hepatic function abnormal 160.84 10.01 359 91824 44004 34820744
Toxicity to various agents 127.02 10.01 208 91975 200154 34664594
Off label use 112.31 10.01 649 91534 418875 34445873
Alanine aminotransferase increased 109.70 10.01 463 91720 80352 34784396
Aspartate aminotransferase increased 109.41 10.01 410 91773 67373 34797375
Platelet count decreased 97.58 10.01 594 91589 119123 34745625
Completed suicide 89.91 10.01 76 92107 98092 34766656
Liver disorder 85.61 10.01 235 91948 32762 34831986
Disseminated intravascular coagulation 79.53 10.01 177 92006 21639 34843109
General physical health deterioration 76.75 10.01 138 92045 128131 34736617
White blood cell count decreased 67.51 10.01 457 91726 94988 34769760
Neutrophil count decreased 62.59 10.01 284 91899 50820 34813928
Aplastic anaemia 53.83 10.01 94 92089 9622 34855126
Drug interaction 48.40 10.01 373 91810 225573 34639175
Treatment failure 44.16 10.01 35 92148 46662 34818086
Blood lactate dehydrogenase increased 43.87 10.01 147 92036 22843 34841905
Drug resistance 43.23 10.01 8 92175 25919 34838829
Infusion related reaction 42.98 10.01 263 91920 52794 34811954
Upper respiratory tract inflammation 42.68 10.01 36 92147 1708 34863040
Chronic kidney disease 41.80 10.01 217 91966 40993 34823755
Pneumonia 39.96 10.01 1244 90939 361383 34503365
Interstitial lung disease 39.42 10.01 301 91882 64981 34799767
Overdose 36.96 10.01 120 92063 90939 34773809
Blood alkaline phosphatase increased 36.49 10.01 171 92012 31004 34833744
Febrile neutropenia 35.51 10.01 532 91651 136317 34728431
Pyrexia 35.50 10.01 1138 91045 331875 34532873
Drug intolerance 34.78 10.01 65 92118 59505 34805243
Therapeutic product effect incomplete 34.30 10.01 50 92133 50491 34814257
Cerebral infarction 33.92 10.01 153 92030 27302 34837446
Lymphocyte stimulation test positive 33.80 10.01 22 92161 698 34864050
Rheumatoid arthritis 33.30 10.01 31 92152 38207 34826541
Product use in unapproved indication 32.73 10.01 179 92004 117320 34747428
Intentional product use issue 32.56 10.01 68 92115 59748 34805000
Intentional product misuse 31.07 10.01 45 92138 45566 34819182
Pneumonitis 28.11 10.01 169 92014 33709 34831039
Enterocolitis 27.99 10.01 64 92119 7962 34856786
Decreased appetite 27.63 10.01 603 91580 165789 34698959
Foetal exposure during pregnancy 26.53 10.01 37 92146 38064 34826684
Blood bilirubin increased 26.22 10.01 182 92001 38114 34826634
Blood creatine phosphokinase MB increased 25.36 10.01 28 92155 1858 34862890
Acute respiratory failure 24.84 10.01 153 92030 30775 34833973
Pneumonia bacterial 24.52 10.01 78 92105 11794 34852954
Blood urea increased 24.26 10.01 150 92033 30214 34834534
Infective pulmonary exacerbation of cystic fibrosis 23.46 10.01 54 92129 6747 34858001
Hypoxia 22.86 10.01 234 91949 54861 34809887
Rash 22.83 10.01 758 91425 221994 34642754
Burkholderia test positive 22.77 10.01 20 92163 1003 34863745
Constipation 21.96 10.01 494 91689 136488 34728260
Cytokine release syndrome 21.51 10.01 118 92065 22759 34841989
Erythema multiforme 20.85 10.01 60 92123 8589 34856159
Anaphylactic reaction 20.65 10.01 151 92032 32150 34832598
Urticaria 20.46 10.01 253 91930 62124 34802624
Cardiogenic shock 20.45 10.01 24 92159 26594 34838154
Contraindicated product administered 20.43 10.01 16 92167 21465 34843283
Plasma cell myeloma 20.12 10.01 184 91999 41853 34822895
Musculoskeletal stiffness 20.00 10.01 60 92123 46620 34818128
Arthropathy 19.89 10.01 25 92158 26882 34837866
Pneumonia aspiration 19.85 10.01 183 92000 41720 34823028
Haematocrit decreased 19.69 10.01 149 92034 32067 34832681
Joint swelling 19.69 10.01 86 92097 59804 34804944
Stomatitis 19.30 10.01 184 91999 42330 34822418
Blood pressure ambulatory increased 19.04 10.01 7 92176 59 34864689
Blood albumin decreased 18.57 10.01 78 92105 13494 34851254
Respiratory failure 18.49 10.01 395 91788 108177 34756571
Intentional overdose 18.10 10.01 57 92126 43617 34821131
Pharyngeal dystonia 17.99 10.01 7 92176 70 34864678
Hiccups 17.95 10.01 63 92120 10019 34854729
Prohormone brain natriuretic peptide increased 17.48 10.01 7 92176 76 34864672
Hypoalbuminaemia 16.68 10.01 70 92113 12104 34852644
End stage renal disease 16.32 10.01 56 92127 8805 34855943
White blood cell count increased 16.22 10.01 173 92010 40978 34823770
Lactic acidosis 16.15 10.01 43 92140 34729 34830019
Psychotic disorder 15.80 10.01 25 92158 24427 34840321
Catheter site haemorrhage 15.69 10.01 24 92159 2200 34862548
Flushing 15.56 10.01 142 92041 32278 34832470
Drug dependence 15.42 10.01 25 92158 24192 34840556
PO2 increased 15.28 10.01 13 92170 624 34864124
Blood pressure fluctuation 15.22 10.01 27 92156 25222 34839526
Cholangitis acute 15.20 10.01 15 92168 873 34863875
Inappropriate schedule of product administration 15.16 10.01 99 92084 62197 34802551
Cardiac autonomic neuropathy 15.16 10.01 6 92177 63 34864685
Pneumonia staphylococcal 15.14 10.01 28 92155 2996 34861752
Wound secretion 15.04 10.01 26 92157 2639 34862109
Glossectomy 14.82 10.01 3 92180 0 34864748
Blood pressure decreased 14.82 10.01 204 91979 51311 34813437
Ventricular tachycardia 14.63 10.01 120 92063 26459 34838289
Gastrointestinal mucosal necrosis 14.59 10.01 8 92175 184 34864564
Torsade de pointes 14.56 10.01 47 92136 7162 34857586
Platelet transfusion 14.52 10.01 19 92164 1507 34863241
Eczema asteatotic 14.36 10.01 9 92174 267 34864481
Frequent bowel movements 14.21 10.01 8 92175 12779 34851969
Visual evoked potentials abnormal 14.16 10.01 6 92177 76 34864672
Sepsis 14.14 10.01 555 91628 166006 34698742
Conduction disorder 13.81 10.01 22 92161 2088 34862660
Blood pressure systolic increased 13.43 10.01 25 92158 22927 34841821
Cystic fibrosis 13.29 10.01 19 92164 1639 34863109
Spasmodic dysphonia 13.24 10.01 8 92175 222 34864526
Hepatocellular injury 13.17 10.01 24 92159 22187 34842561
Burkholderia infection 13.13 10.01 6 92177 92 34864656
Polyneuropathy 13.06 10.01 12 92171 14884 34849864
Coma 13.03 10.01 69 92114 45609 34819139
Stevens-Johnson syndrome 13.00 10.01 89 92094 18550 34846198
Convulsive threshold lowered 12.95 10.01 11 92172 527 34864221
Hepatotoxicity 12.93 10.01 23 92160 21462 34843286
Haematotoxicity 12.69 10.01 3 92180 8191 34856557
Amino acid level increased 12.66 10.01 10 92173 432 34864316
Weight increased 12.64 10.01 171 92012 92862 34771886
Mast cell activation syndrome 12.63 10.01 8 92175 242 34864506
Anal erosion 12.33 10.01 4 92179 22 34864726
Sputum retention 12.27 10.01 10 92173 452 34864296
Therapy partial responder 12.24 10.01 5 92178 9611 34855137
Supine hypertension 12.22 10.01 9 92174 350 34864398
Renal impairment 12.18 10.01 331 91852 94182 34770566
Hypertensive crisis 12.07 10.01 4 92179 8747 34856001
CADASIL 12.07 10.01 6 92177 112 34864636
Gamma-glutamyltransferase increased 12.04 10.01 124 92059 29107 34835641
Hospice care 12.04 10.01 43 92140 6897 34857851
Human ehrlichiosis 11.93 10.01 9 92174 363 34864385
Loss of personal independence in daily activities 11.93 10.01 46 92137 33133 34831615
Disease prodromal stage 11.91 10.01 4 92179 25 34864723
Protein total decreased 11.80 10.01 35 92148 5095 34859653
Convulsions local 11.77 10.01 4 92179 26 34864722
Pulmonary fibrosis 11.71 10.01 19 92164 18377 34846371
Hyperuricaemia 11.61 10.01 47 92136 7996 34856752
Aggression 11.59 10.01 58 92125 38906 34825842
Cerebral microangiopathy 11.56 10.01 7 92176 195 34864553
Post procedural haematoma 11.52 10.01 17 92166 1509 34863239
Substance abuse 11.44 10.01 3 92180 7638 34857110
Suicide attempt 11.20 10.01 59 92124 39057 34825691
Jaundice hepatocellular 11.04 10.01 5 92178 75 34864673
Progressive multifocal leukoencephalopathy 11.01 10.01 6 92177 9758 34854990
Gastric perforation 10.98 10.01 22 92161 2498 34862250
Oral pruritus 10.88 10.01 8 92175 310 34864438
Sputum culture positive 10.83 10.01 18 92165 1770 34862978
Magnetic resonance imaging spinal abnormal 10.82 10.01 6 92177 141 34864607
Eosinophil count increased 10.75 10.01 48 92135 8524 34856224
Lower respiratory tract infection 10.66 10.01 45 92138 31592 34833156
Product use issue 10.58 10.01 111 92072 63105 34801643
Blood creatinine increased 10.43 10.01 326 91857 94650 34770098
Ventricular flutter 10.37 10.01 5 92178 87 34864661
Post procedural complication 10.21 10.01 58 92125 11330 34853418
Oral dysaesthesia 10.17 10.01 5 92178 91 34864657
Laboratory test abnormal 10.13 10.01 90 92093 20301 34844447
Extravasation 10.10 10.01 18 92165 1872 34862876
Lipid metabolism disorder 10.08 10.01 8 92175 348 34864400
Arthralgia 10.07 10.01 357 91826 169684 34695064
Troponin I increased 10.04 10.01 22 92161 2660 34862088

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 416.71 9.28 1225 184797 1079688 78478678
Synovitis 283.42 9.28 17 186005 150717 79407649
Hepatic function abnormal 262.61 9.28 548 185474 72559 79485807
Drug intolerance 257.63 9.28 148 185874 263971 79294395
Contraindicated product administered 248.15 9.28 36 185986 157502 79400864
Drug abuse 247.58 9.28 41 185981 162650 79395716
Joint swelling 236.06 9.28 196 185826 288450 79269916
Pemphigus 212.19 9.28 4 186018 99578 79458788
Arthropathy 210.49 9.28 75 185947 177036 79381330
Platelet count decreased 206.00 9.28 950 185072 193714 79364652
Treatment failure 201.23 9.28 73 185949 170413 79387953
Hand deformity 200.68 9.28 10 186012 103909 79454457
Off label use 187.57 9.28 1294 184728 905921 78652445
Toxicity to various agents 187.09 9.28 444 185578 421096 79137270
Rheumatoid arthritis 183.82 9.28 131 185891 208339 79350027
Therapeutic product effect decreased 182.12 9.28 77 185945 163786 79394580
Aspartate aminotransferase increased 176.87 9.28 716 185306 137925 79420441
General physical health deterioration 165.34 9.28 241 185781 274997 79283369
Alanine aminotransferase increased 156.41 9.28 772 185250 161798 79396568
White blood cell count decreased 148.23 9.28 846 185176 187442 79370924
Systemic lupus erythematosus 132.89 9.28 58 185964 121091 79437275
Glossodynia 129.32 9.28 40 185982 103297 79455069
Pericarditis 129.28 9.28 41 185981 104195 79454171
Disseminated intravascular coagulation 129.04 9.28 269 185753 35573 79522793
Duodenal ulcer perforation 122.83 9.28 8 186014 66203 79492163
Pneumonia aspiration 115.93 9.28 382 185640 66585 79491781
Lower respiratory tract infection 111.52 9.28 83 185939 129137 79429229
Helicobacter infection 107.27 9.28 17 186005 69687 79488679
Cytokine release syndrome 105.70 9.28 249 185773 35749 79522617
Neutrophil count decreased 101.09 9.28 461 185561 93498 79464868
Completed suicide 98.00 9.28 273 185749 245494 79312872
Flushing 97.90 9.28 437 185585 87831 79470535
Musculoskeletal stiffness 95.76 9.28 163 185859 174845 79383521
C-reactive protein abnormal 95.50 9.28 4 186018 48363 79510003
Wound 94.73 9.28 79 185943 116100 79442266
Liver disorder 93.89 9.28 376 185646 72041 79486325
Gastrooesophageal reflux disease 93.85 9.28 486 185536 103760 79454606
Mobility decreased 92.52 9.28 89 185933 122086 79436280
Therapeutic product effect incomplete 92.07 9.28 117 185905 141528 79416838
Muscle injury 89.68 9.28 6 186016 48555 79509811
Blood lactate dehydrogenase increased 88.08 9.28 245 185777 38925 79519441
Sleep disorder due to general medical condition, insomnia type 88.06 9.28 3 186019 43553 79514813
Arthralgia 85.52 9.28 887 185135 570916 78987450
Febrile neutropenia 84.01 9.28 866 185156 230133 79328233
Aplastic anaemia 82.30 9.28 149 185873 17756 79540610
Psoriatic arthropathy 81.41 9.28 40 185982 77959 79480407
Folliculitis 79.80 9.28 16 186006 55364 79503002
Interstitial lung disease 78.96 9.28 491 185531 112109 79446257
Product use issue 77.88 9.28 241 185781 209581 79348785
Type I hypersensitivity 74.69 9.28 70 185952 4328 79554038
Upper respiratory tract inflammation 71.96 9.28 66 185956 3969 79554397
Discomfort 71.49 9.28 114 185908 125503 79432863
Cerebral infarction 68.12 9.28 248 185774 45428 79512938
Chronic kidney disease 67.77 9.28 320 185702 65834 79492532
Anaphylactic reaction 66.30 9.28 377 185645 83366 79475000
Intentional product use issue 65.92 9.28 162 185860 151950 79406416
Enterocolitis 63.22 9.28 118 185904 14394 79543972
Drug hypersensitivity 63.07 9.28 423 185599 298493 79259873
Red blood cell sedimentation rate increased 62.70 9.28 15 186007 45927 79512439
Hepatic enzyme increased 62.06 9.28 218 185804 182392 79375974
Irritable bowel syndrome 61.87 9.28 34 185988 62207 79496159
Sopor 61.19 9.28 4 186018 33006 79525360
Decreased appetite 60.02 9.28 1127 184895 341291 79217075
Alopecia 58.52 9.28 309 185713 231046 79327320
Pneumonia 58.33 9.28 1981 184041 658265 78900101
Lymphocyte stimulation test positive 58.07 9.28 35 185987 1098 79557268
Drug resistance 57.18 9.28 14 186008 42199 79516167
Blood alkaline phosphatase increased 56.72 9.28 296 185726 63368 79494998
Acute respiratory failure 56.66 9.28 282 185740 59259 79499107
Maternal exposure during pregnancy 56.39 9.28 149 185873 136389 79421977
Fibromyalgia 55.92 9.28 41 185981 64299 79494067
Overdose 54.20 9.28 233 185789 183973 79374393
Chest discomfort 50.36 9.28 518 185504 137526 79420840
Pyrexia 49.88 9.28 1995 184027 676714 78881652
Blood bilirubin increased 49.71 9.28 294 185728 65938 79492428
Swelling 49.62 9.28 299 185723 216412 79341954
Hypoxia 49.58 9.28 411 185611 102832 79455534
Cholecystitis chronic 47.53 9.28 84 185938 9822 79548544
Infective pulmonary exacerbation of cystic fibrosis 46.89 9.28 97 185925 12754 79545612
Dehydration 46.66 9.28 826 185196 247361 79311005
Impaired healing 45.79 9.28 84 185938 87571 79470795
Hepatic cytolysis 43.21 9.28 6 186016 27145 79531221
Sepsis 43.19 9.28 875 185147 268553 79289813
Blood pressure fluctuation 43.06 9.28 56 185966 67089 79491277
Knee arthroplasty 42.44 9.28 24 185998 43224 79515142
Hepatocellular injury 40.49 9.28 31 185991 47562 79510804
Weight increased 39.85 9.28 434 185588 276952 79281414
Erythema multiforme 39.28 9.28 110 185912 17541 79540825
Arthritis 39.11 9.28 137 185885 114743 79443623
Urticaria 39.04 9.28 628 185394 184573 79373793
Mast cell activation syndrome 38.87 9.28 23 185999 697 79557669
Ill-defined disorder 38.21 9.28 59 185963 65816 79492550
Loss of personal independence in daily activities 37.91 9.28 118 185904 102462 79455904
Plasma cell myeloma 37.79 9.28 233 185789 53026 79505340
Mental status changes 37.36 9.28 276 185746 66683 79491683
Blood creatine phosphokinase MB increased 37.10 9.28 39 185983 2772 79555594
Torsade de pointes 36.90 9.28 114 185908 19198 79539168
Liver injury 36.53 9.28 47 185975 56567 79501799
Pain 36.11 9.28 1311 184711 702491 78855875
Blister 35.82 9.28 150 185872 119326 79439040
Drug interaction 35.79 9.28 718 185304 414465 79143901
Pneumonitis 35.76 9.28 254 185768 60606 79497760
Blood pressure systolic increased 35.15 9.28 64 185958 66922 79491444
Butterfly rash 34.74 9.28 30 185992 1666 79556700
White blood cell count increased 34.71 9.28 295 185727 74338 79484028
Blood urea increased 34.33 9.28 213 185809 48577 79509789
Pneumonia bacterial 34.09 9.28 111 185911 19220 79539146
Urinary tract infection 33.81 9.28 859 185163 273653 79284713
Drug eruption 33.59 9.28 196 185826 43739 79514627
Hip arthroplasty 33.46 9.28 21 186001 35735 79522631
Gastrointestinal disorder 33.28 9.28 159 185863 122046 79436320
Medication error 33.06 9.28 69 185953 68573 79489793
Intentional product misuse 32.72 9.28 113 185909 95052 79463314
Constipation 32.34 9.28 877 185145 282173 79276193
Lip swelling 32.25 9.28 184 185838 40727 79517639
Haematocrit decreased 31.56 9.28 248 185774 61064 79497302
Throat tightness 30.80 9.28 138 185884 27769 79530597
Blood albumin decreased 30.71 9.28 125 185897 24118 79534248
Protein total decreased 30.14 9.28 66 185956 9026 79549340
Abdominal discomfort 29.31 9.28 410 185612 250317 79308049
Chills 28.93 9.28 530 185492 159704 79398662
Ventricular tachycardia 28.84 9.28 182 185840 41753 79516613
Hospice care 28.78 9.28 70 185952 10254 79548112
Respiratory failure 28.46 9.28 586 185436 180325 79378041
Musculoskeletal pain 27.97 9.28 133 185889 102221 79456145
Hepatotoxicity 27.91 9.28 48 185974 51304 79507062
Periorbital oedema 27.86 9.28 61 185961 8341 79550025
Pulmonary fibrosis 27.06 9.28 38 185984 44074 79514292
Peripheral swelling 26.72 9.28 455 185567 269162 79289204
Angioedema 26.62 9.28 283 185739 75752 79482614
COVID-19 26.22 9.28 515 185507 157159 79401207
Condition aggravated 26.21 9.28 931 185091 500193 79058173
Haemorrhage subcutaneous 26.00 9.28 43 185979 4766 79553600
Dermatitis atopic 25.74 9.28 66 185956 9990 79548376
Granulocytopenia 25.20 9.28 71 185951 11360 79547006
Therapy non-responder 25.19 9.28 120 185902 92185 79466181
Contusion 25.02 9.28 224 185798 148552 79409814
Blood pressure diastolic abnormal 24.80 9.28 7 186015 19195 79539171
Renal impairment 24.78 9.28 511 185511 157272 79401094
Swelling face 24.44 9.28 264 185758 70948 79487418
Emotional distress 24.17 9.28 168 185854 39801 79518565
Blood creatinine increased 23.97 9.28 501 185521 154556 79403810
Hypoalbuminaemia 23.27 9.28 105 185917 21192 79537174
Hyperuricaemia 22.87 9.28 70 185952 11729 79546637
Polyneuropathy 22.85 9.28 14 186008 24137 79534229
Blood magnesium decreased 22.41 9.28 87 185935 16425 79541941
Throat irritation 22.40 9.28 168 185854 40778 79517588
Burkholderia test positive 22.32 9.28 15 186007 570 79557796
End stage renal disease 22.30 9.28 71 185951 12149 79546217
Vaccination site reaction 21.88 9.28 9 186013 120 79558246
Nasopharyngitis 21.86 9.28 439 185583 253442 79304924
Intentional overdose 21.79 9.28 151 185871 105809 79452557
Blood cholesterol increased 21.60 9.28 111 185911 83609 79474757
Diarrhoea 21.44 9.28 2356 183666 878133 78680233
Tenosynovitis 21.38 9.28 5 186017 15549 79542817
Exposure during pregnancy 20.85 9.28 144 185878 100988 79457378
Infection 20.80 9.28 418 185604 241294 79317072
Nausea 20.47 9.28 2540 183482 954656 78603710
Gallbladder disorder 20.13 9.28 94 185928 19246 79539120
Pleural effusion 20.11 9.28 462 185560 144800 79413566
Cholecystitis acute 20.02 9.28 73 185949 13378 79544988
Haemoglobin decreased 19.90 9.28 668 185354 221451 79336915
Gastritis 19.89 9.28 185 185837 47808 79510558
Asteatosis 19.77 9.28 8 186014 102 79558264
Joint stiffness 19.70 9.28 41 185981 40789 79517577
Drug dependence 19.61 9.28 41 185981 40728 79517638
Inflammation 19.57 9.28 133 185889 93620 79464746
Blood pressure ambulatory increased 19.47 9.28 7 186015 63 79558303
Blood pressure systolic abnormal 19.31 9.28 8 186014 17239 79541127
Osteoarthritis 19.17 9.28 122 185900 87187 79471179
Poisoning deliberate 19.13 9.28 10 186012 18818 79539548
Joint range of motion decreased 19.12 9.28 30 185992 33252 79525114
Grip strength decreased 18.92 9.28 14 186008 21855 79536511
Renal injury 18.90 9.28 84 185938 16843 79541523
Palmar erythema 18.85 9.28 23 185999 1924 79556442
Stevens-Johnson syndrome 18.84 9.28 156 185866 39010 79519356
Therapeutic response decreased 18.78 9.28 86 185936 66767 79491599
Biliary dyskinesia 18.34 9.28 26 185996 2519 79555847
Prescribed overdose 18.31 9.28 38 185984 37845 79520521
Blood potassium decreased 18.14 9.28 177 185845 46335 79512031
Osteoporosis 18.10 9.28 65 185957 54047 79504319
Psychotic disorder 18.00 9.28 44 185978 41358 79517008
Non-cardiac chest pain 17.99 9.28 56 185966 9468 79548898
Sedation complication 17.98 9.28 7 186015 15662 79542704
Blood pressure decreased 17.94 9.28 329 185693 99137 79459229
Small intestinal obstruction 17.91 9.28 117 185905 27155 79531211
Hypervolaemia 17.91 9.28 165 185857 42525 79515841
Impaired work ability 17.81 9.28 12 186010 19669 79538697
Extrapyramidal disorder 17.77 9.28 16 186006 22663 79535703
Haematotoxicity 17.70 9.28 7 186015 15512 79542854
Disease progression 17.42 9.28 558 185464 183804 79374562
Heart rate decreased 17.16 9.28 95 185927 70221 79488145
Gamma-glutamyltransferase increased 17.08 9.28 199 185823 54481 79503885
Weight fluctuation 17.07 9.28 63 185959 11612 79546754
Platelet transfusion 16.98 9.28 24 185998 2318 79556048
Pain in extremity 16.88 9.28 687 185335 363851 79194515
Basal cell carcinoma 16.82 9.28 39 185983 37336 79521030
Foot deformity 16.57 9.28 19 186003 24055 79534311
Cholestasis 16.51 9.28 64 185958 52045 79506321
Deep vein thrombosis 16.25 9.28 383 185639 120536 79437830
Ventricular flutter 16.22 9.28 7 186015 106 79558260
Blindness transient 16.21 9.28 35 185987 4741 79553625
Red blood cell count decreased 16.09 9.28 205 185817 57308 79501058
Product use in unapproved indication 15.99 9.28 453 185569 249906 79308460
Autoimmune hepatitis 15.92 9.28 62 185960 11721 79546645
Hypertensive crisis 15.87 9.28 15 186007 20755 79537611
Chest pain 15.87 9.28 808 185214 281496 79276870
Laboratory test abnormal 15.86 9.28 116 185906 27932 79530434
Musculoskeletal disorder 15.79 9.28 16 186006 21432 79536934
Cardiac autonomic neuropathy 15.79 9.28 6 186016 64 79558302
Hereditary angioedema 15.76 9.28 37 185985 5298 79553068
Ileus 15.75 9.28 110 185912 26101 79532265
Bursitis 15.65 9.28 38 185984 35806 79522560
Injection site pain 15.63 9.28 211 185811 129627 79428739
Pneumothorax 15.37 9.28 116 185906 28207 79530159
Device difficult to use 15.33 9.28 6 186016 13379 79544987
Tumour lysis syndrome 15.30 9.28 102 185920 23837 79534529
Dyspnoea 15.28 9.28 2250 183772 854775 78703591
Balance disorder 15.27 9.28 152 185870 98705 79459661
Rhinovirus infection 15.24 9.28 47 185975 7906 79550460
Therapy partial responder 15.23 9.28 11 186011 17386 79540980
Glossectomy 15.19 9.28 3 186019 0 79558366
Lymphocyte count decreased 15.17 9.28 173 185849 47116 79511250
Pharyngeal swelling 15.15 9.28 46 185976 7673 79550693
Tubulointerstitial nephritis 15.15 9.28 146 185876 38089 79520277
Cystic fibrosis 15.00 9.28 30 185992 3850 79554516
Back pain 14.99 9.28 860 185162 303320 79255046
Basophil count decreased 14.94 9.28 9 186013 282 79558084
Post procedural complication 14.91 9.28 101 185921 23728 79534638
Circulatory collapse 14.87 9.28 42 185980 37626 79520740
Renal disorder 14.87 9.28 157 185865 41948 79516418
Status asthmaticus 14.83 9.28 15 186007 1019 79557347
Facet joint syndrome 14.82 9.28 4 186018 11298 79547068
Frequent bowel movements 14.81 9.28 29 185993 29510 79528856
Neuroleptic malignant syndrome 14.76 9.28 26 185996 27533 79530833
Cholangitis acute 14.68 9.28 18 186004 1514 79556852
Therapy cessation 14.67 9.28 143 185879 37419 79520947
Dysphagia 14.66 9.28 381 185641 121755 79436611
Drug tolerance decreased 14.57 9.28 6 186016 12972 79545394
Congenital neuropathy 14.50 9.28 4 186018 13 79558353
Gallbladder injury 14.46 9.28 16 186006 1205 79557161
Lethargy 14.35 9.28 268 185754 81024 79477342
Anaphylactoid reaction 14.31 9.28 36 185986 5386 79552980
Gastrointestinal mucosal necrosis 14.15 9.28 8 186014 222 79558144
Type 2 diabetes mellitus 14.03 9.28 77 185945 57045 79501321
Bacteriuria 13.94 9.28 16 186006 1255 79557111
Cystoid macular oedema 13.93 9.28 20 186002 1960 79556406
Sleep disorder due to a general medical condition 13.90 9.28 8 186014 14269 79544097
Respiratory distress 13.88 9.28 202 185820 58137 79500229
Haemodialysis 13.85 9.28 81 185941 18087 79540279
Carcinoembryonic antigen 13.83 9.28 6 186016 92 79558274
Breast cancer stage III 13.82 9.28 3 186019 9823 79548543
Swollen tongue 13.77 9.28 156 185866 42414 79515952
Fibrin D dimer increased 13.76 9.28 48 185974 8606 79549760
Carbohydrate antigen 15-3 13.66 9.28 6 186016 95 79558271
Peritonitis 13.66 9.28 112 185910 27924 79530442
Post procedural haematoma 13.42 9.28 22 186000 2420 79555946
Anaplastic astrocytoma 13.42 9.28 7 186015 165 79558201
Cystitis noninfective 13.25 9.28 16 186006 1324 79557042
Hypophagia 13.24 9.28 163 185859 45204 79513162
Cholecystitis 13.22 9.28 93 185929 22119 79536247
Sciatica 13.15 9.28 37 185985 33185 79525181
Heparin-induced thrombocytopenia 13.13 9.28 51 185971 9631 79548735
Anaemia 13.13 9.28 1207 184815 443808 79114558
Breast adenoma 13.10 9.28 5 186017 54 79558312
Illness 13.10 9.28 166 185856 46345 79512021
Dermatitis acneiform 13.03 9.28 52 185970 9941 79548425
Full blood count decreased 12.99 9.28 107 185915 26712 79531654
Infusion site erythema 12.97 9.28 50 185972 9410 79548956
Eosinophil count increased 12.87 9.28 76 185946 17029 79541337
Gastrointestinal haemorrhage 12.65 9.28 442 185580 147277 79411089
Milk allergy 12.62 9.28 6 186016 115 79558251
Ammonia decreased 12.53 9.28 4 186018 24 79558342
Adverse drug reaction 12.50 9.28 97 185925 66295 79492071
Catheter site haemorrhage 12.50 9.28 33 185989 5084 79553282
Cholinergic syndrome 12.46 9.28 14 186008 1073 79557293
Seasonal allergy 12.42 9.28 73 185949 16333 79542033
Cholelithiasis 12.39 9.28 182 185840 52482 79505884
Ischaemic stroke 12.31 9.28 38 185984 33093 79525273
Intentional self-injury 12.18 9.28 37 185985 32382 79525984
Brain natriuretic peptide increased 12.17 9.28 47 185975 8853 79549513
Amylase increased 12.05 9.28 55 185967 11154 79547212
Malignant neoplasm progression 11.92 9.28 408 185614 135582 79422784
Administration site inflammation 11.91 9.28 3 186019 6 79558360
Supine hypertension 11.86 9.28 9 186013 415 79557951
Chronic gastritis 11.79 9.28 28 185994 4040 79554326
Blood pressure diastolic decreased 11.70 9.28 34 185988 30182 79528184
Catatonia 11.67 9.28 3 186019 8753 79549613
Toxic epidermal necrolysis 11.67 9.28 157 185865 44424 79513942
Live birth 11.64 9.28 16 186006 18728 79539638
Post procedural haemorrhage 11.62 9.28 63 185959 13681 79544685
Acquired haemophilia 11.58 9.28 18 186004 1893 79556473
Drug use disorder 11.46 9.28 3 186019 8648 79549718
Suicide attempt 11.40 9.28 131 185891 82801 79475565
Total lung capacity abnormal 11.35 9.28 7 186015 229 79558137
Night sweats 11.33 9.28 73 185949 52022 79506344
Pregnancy 11.31 9.28 29 185993 26822 79531544
Lymphatic disorder 11.28 9.28 8 186014 332 79558034
Product dose omission issue 11.27 9.28 695 185327 246842 79311524
Disability 11.26 9.28 14 186008 17106 79541260
Dizziness 11.20 9.28 1397 184625 525044 79033322
Cardiogenic shock 11.14 9.28 55 185967 41859 79516507
Hypokalaemia 11.12 9.28 426 185596 143614 79414752
Chronic spontaneous urticaria 11.11 9.28 14 186008 1210 79557156
Cellulitis 11.07 9.28 333 185689 108727 79449639
Gastrointestinal oedema 11.04 9.28 21 186001 2597 79555769
Joint dislocation 10.99 9.28 14 186008 16925 79541441
Gastric perforation 10.86 9.28 27 185995 4010 79554356
Haemorrhagic diathesis 10.79 9.28 35 185987 6049 79552317
Eye haematoma 10.76 9.28 6 186016 162 79558204
Pleural neoplasm 10.72 9.28 8 186014 360 79558006
Intercepted medication error 10.71 9.28 12 186010 917 79557449
Metabolic encephalopathy 10.68 9.28 46 185976 9101 79549265
Drug-induced liver injury 10.66 9.28 215 185807 65902 79492464
Cognitive disorder 10.59 9.28 108 185914 69818 79488548
Hepatitis cholestatic 10.59 9.28 10 186012 13842 79544524
Cranial nerve disorder 10.57 9.28 13 186009 1097 79557269
Blood pressure diastolic increased 10.54 9.28 11 186011 14531 79543835
Hyperlipidaemia 10.52 9.28 100 185922 25993 79532373
Paronychia 10.48 9.28 41 185981 7767 79550599
Heart transplant 10.48 9.28 15 186007 1466 79556900
Pneumonia staphylococcal 10.48 9.28 30 185992 4844 79553522
Urine osmolarity decreased 10.42 9.28 5 186017 98 79558268
Foetal heart rate abnormal 10.41 9.28 8 186014 376 79557990
Lung disorder 10.40 9.28 129 185893 80428 79477938
Nephrogenic anaemia 10.39 9.28 26 185996 3876 79554490
Cardiac arrest 10.37 9.28 496 185526 171600 79386766
Breast cancer female 10.36 9.28 7 186015 11454 79546912
Putamen haemorrhage 10.30 9.28 9 186013 508 79557858
Psoriasis 10.28 9.28 147 185875 89440 79468926
Pityriasis lichenoides et varioliformis acuta 10.26 9.28 4 186018 46 79558320
Coronary artery dissection 10.25 9.28 13 186009 1131 79557235
Haemolytic anaemia 10.25 9.28 74 185948 17746 79540620
Rash 10.23 9.28 1518 184504 576840 78981526
Pathogen resistance 10.22 9.28 11 186011 14331 79544035
Infusion related hypersensitivity reaction 10.18 9.28 8 186014 389 79557977
Coeliac disease 10.17 9.28 7 186015 11344 79547022
Prohormone brain natriuretic peptide increased 10.17 9.28 7 186015 277 79558089
Altered state of consciousness 10.14 9.28 151 185871 43671 79514695
Lactic acidosis 10.12 9.28 110 185912 70249 79488117
Oropharyngeal swelling 10.12 9.28 14 186008 1326 79557040
Pruritus 10.11 9.28 1060 184962 393588 79164778
Pharyngeal dystonia 10.10 9.28 4 186018 48 79558318
Restless arm syndrome 10.10 9.28 4 186018 48 79558318
Substance abuse 10.10 9.28 6 186016 10520 79547846
Palmar-plantar erythrodysaesthesia syndrome 10.09 9.28 120 185902 33014 79525352
Hypersomnia 10.08 9.28 90 185932 22996 79535370
Cancer pain 10.06 9.28 31 185991 5214 79553152
VIIth nerve injury 10.05 9.28 6 186016 185 79558181
Mucocutaneous rash 10.03 9.28 4 186018 49 79558317
Anal erosion 10.03 9.28 4 186018 49 79558317
Troponin I increased 10.03 9.28 29 185993 4709 79553657
Ulcer 10.02 9.28 36 185986 29936 79528430
Abdominal distension 9.99 9.28 357 185665 119293 79439073
Atelectasis 9.90 9.28 117 185905 32140 79526226
Sputum culture positive 9.87 9.28 25 185997 3756 79554610
Lower limb fracture 9.83 9.28 25 185997 23190 79535176
Cytomegalovirus infection reactivation 9.83 9.28 4 186018 8712 79549654
Cerebral haemorrhage 9.79 9.28 189 185833 57484 79500882
Schizophrenia 9.77 9.28 13 186009 15427 79542939
Mean arterial pressure increased 9.75 9.28 4 186018 53 79558313
Heliotrope rash 9.74 9.28 6 186016 196 79558170
Flashback 9.74 9.28 7 186015 297 79558069
PO2 increased 9.68 9.28 15 186007 1573 79556793
Injection site bruising 9.67 9.28 56 185966 40946 79517420
Iron deficiency anaemia 9.67 9.28 97 185925 25575 79532791
Product prescribing error 9.64 9.28 63 185959 44750 79513616
Tinea pedis 9.60 9.28 19 186003 2421 79555945
Hypergeusia 9.54 9.28 3 186019 17 79558349
Unresponsive to stimuli 9.53 9.28 183 185839 55605 79502761
Autoimmune disorder 9.52 9.28 15 186007 16597 79541769
Conduction disorder 9.51 9.28 23 185999 3356 79555010
COVID-19 pneumonia 9.46 9.28 106 185916 28743 79529623
PCO2 decreased 9.46 9.28 22 186000 3132 79555234
Carotid artery stenosis 9.43 9.28 43 185979 8715 79549651
Benign vulval neoplasm 9.42 9.28 4 186018 58 79558308
Infusion site pain 9.42 9.28 61 185961 14115 79544251
Lymphocyte percentage increased 9.42 9.28 10 186012 719 79557647
Tuberculosis 9.41 9.28 13 186009 15185 79543181
Surfactant protein increased 9.39 9.28 3 186019 18 79558348
Human chorionic gonadotropin decreased 9.39 9.28 3 186019 18 79558348
Blood creatine phosphokinase increased 9.39 9.28 211 185811 65879 79492487
Mucormycosis 9.37 9.28 4 186018 8465 79549901
Respiratory depression 9.37 9.28 33 185989 27597 79530769
Pulmonary hypertension 9.37 9.28 161 185861 47919 79510447
Gastroenteritis 9.33 9.28 121 185901 33961 79524405
Dyslalia 9.32 9.28 12 186010 1060 79557306
Small intestinal haemorrhage 9.32 9.28 26 185996 4137 79554229
Pancreatic enlargement 9.29 9.28 6 186016 213 79558153

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




🐶 Veterinary Drug Use

None

🐶 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
5702160 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 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
injoy heartburn relief HUMAN OTC DRUG LABEL 3 0113-6023 TABLET, CHEWABLE 10 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 0187-4420 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
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
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 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 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 0363-1899 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