famotidine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -0.591 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 2.323 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.313 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 0.718 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 88.770 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 87.320 % High 1
herg hERG pIC50 3.607 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.489 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 2.985 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 82.320 % High 1
kinase-safety-class ACVR2A,ACVR2B,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK4,CDK5,CDK9,CSF1R,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,IKBKB,ITK,JAK1,JAK2,KIT,MAP2K6,MAP3K21,MAP3K7,MAP4K1,MAPK10,MAPK7,MAPK9,MAPKAPK2,MARK4,MTOR,NTRK2,PAK4,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1,ULK2 59
kinase-selectivity-class ACVR2A,ACVR2B,AXL,BRAF,CAMK2D,CDK1,CDK16,CDK3,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,FLT3,GRK2,GSK3A,IRAK1,JAK2,MAP2K3,MAP2K6,MAP3K21,MAPK7,PDK1,SIK2,STK33,TEK,ULK1 27
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.656 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.492 High 1
mh-clint Mouse hepatocyte intrinsic clearance 8.750 High 1
mppb Mouse plasma protein binding (% unbound) 89.700 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.734 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 91.100 % High 1
rat-kpuu-brain Rat brain Kpuu 0.011 % High 1
rh-clint Rat hepatocyte intrinsic clearance 1.014 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 96.510 % High 1
rppb Rat plasma protein binding (% unbound) 83.560 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 931.108 uM High 1

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
Pemphigus 488.61 9.60 3 140320 326861 90161263
Hand deformity 423.32 9.60 7 140316 296355 90191769
Synovitis 420.24 9.60 22 140301 329730 90158394
Systemic lupus erythematosus 395.32 9.60 48 140275 361848 90126276
Contraindicated product administered 385.14 9.60 29 140294 320110 90168014
Glossodynia 363.19 9.60 38 140285 321741 90166383
Pericarditis 350.64 9.60 16 140307 270135 90217989
Arthropathy 335.19 9.60 78 140245 366164 90121960
Joint swelling 319.54 9.60 192 140131 503108 89985016
Duodenal ulcer perforation 316.90 9.60 5 140318 221283 90266841
Helicobacter infection 302.55 9.60 11 140312 226839 90261285
Wound 286.32 9.60 60 140263 302920 90185204
Therapeutic product effect decreased 277.07 9.60 48 140275 277523 90210601
Drug intolerance 274.02 9.60 178 140145 447413 90040711
Lower respiratory tract infection 266.95 9.60 36 140287 250623 90237501
Folliculitis 265.47 9.60 12 140311 204341 90283783
Treatment failure 262.11 9.60 73 140250 303855 90184269
Hepatic enzyme increased 213.25 9.60 149 140174 360587 90127537
Platelet count decreased 207.08 9.60 571 139752 136398 90351726
General physical health deterioration 201.68 9.60 153 140170 354962 90133162
Drug ineffective 198.45 9.60 1295 139028 1383003 89105121
Flushing 192.28 9.60 424 139899 88067 90400057
Liver injury 190.14 9.60 21 140302 170546 90317578
Anaphylactic reaction 186.38 9.60 416 139907 87108 90401016
Hepatic function abnormal 184.42 9.60 288 140035 46000 90442124
Rheumatoid arthritis 177.21 9.60 180 140143 362434 90125690
Sleep disorder due to general medical condition, insomnia type 175.97 9.60 5 140318 128689 90359435
Psoriatic arthropathy 173.73 9.60 68 140255 228267 90259857
Maternal exposure during pregnancy 172.26 9.60 182 140141 359881 90128243
C-reactive protein abnormal 170.48 9.60 6 140317 127423 90360701
Impaired healing 168.15 9.60 76 140247 234123 90254001
Irritable bowel syndrome 159.11 9.60 61 140262 207387 90280737
Aplastic anaemia 153.11 9.60 142 140181 13127 90474997
Type 2 diabetes mellitus 152.20 9.60 62 140261 203182 90284942
Swelling 147.97 9.60 264 140059 418794 90069330
Fibromyalgia 147.97 9.60 67 140256 206202 90281922
Mobility decreased 147.52 9.60 104 140219 250630 90237494
White blood cell count decreased 145.67 9.60 578 139745 166531 90321593
Febrile neutropenia 141.50 9.60 552 139771 157797 90330327
Alopecia 134.29 9.60 361 139962 494710 89993414
Ill-defined disorder 134.27 9.60 59 140264 184832 90303292
Joint range of motion decreased 134.08 9.60 24 140299 135619 90352505
Musculoskeletal stiffness 133.98 9.60 157 140166 296375 90191749
Facet joint syndrome 130.33 9.60 5 140318 98384 90389740
Blister 129.81 9.60 122 140201 254876 90233248
Aspartate aminotransferase increased 126.73 9.60 399 139924 102538 90385586
Blood cholesterol increased 125.38 9.60 84 140239 207928 90280196
COVID-19 123.79 9.60 554 139769 168289 90319835
Respiratory syncytial virus test positive 119.16 9.60 49 140274 1009 90487115
Product use issue 118.99 9.60 205 140118 329714 90158410
Chronic kidney disease 118.76 9.60 249 140074 49942 90438182
Alanine aminotransferase increased 116.86 9.60 426 139897 117912 90370212
Lip dry 116.19 9.60 11 140312 100944 90387180
Dehydration 115.14 9.60 600 139723 193847 90294277
Breast cancer stage III 112.86 9.60 4 140319 84443 90403681
Human rhinovirus test positive 112.62 9.60 45 140278 858 90487266
Discomfort 106.85 9.60 162 140161 274173 90213951
Mast cell activation syndrome 105.93 9.60 51 140272 1543 90486581
Bursitis 105.53 9.60 36 140287 131618 90356506
Disseminated intravascular coagulation 102.98 9.60 146 140177 21392 90466732
Grip strength decreased 99.20 9.60 13 140310 92563 90395561
Neutrophil count decreased 99.05 9.60 289 140034 71243 90416881
Nausea 98.60 9.60 2329 137994 1107987 89380137
Chest discomfort 97.67 9.60 449 139874 137916 90350208
Therapeutic product effect incomplete 97.21 9.60 94 140229 193802 90294322
Peripheral venous disease 94.34 9.60 10 140313 83911 90404213
Diarrhoea 93.31 9.60 2002 138321 937188 89550936
Interstitial lung disease 91.14 9.60 293 140030 76112 90412012
Drug hypersensitivity 89.06 9.60 392 139931 463217 90024907
Wound infection 88.98 9.60 27 140296 106375 90381749
Viral test positive 87.05 9.60 34 140289 609 90487515
Inflammation 86.75 9.60 89 140234 178503 90309621
Abdominal discomfort 86.69 9.60 412 139911 476916 90011208
Blood lactate dehydrogenase increased 85.27 9.60 148 140175 25784 90462340
Urinary tract infection 82.85 9.60 779 139544 304853 90183271
Drug abuse 82.62 9.60 14 140309 82333 90405791
Osteoarthritis 80.70 9.60 111 140212 195619 90292505
Musculoskeletal pain 80.20 9.60 88 140235 171163 90316961
Intentional product use issue 79.78 9.60 133 140190 216759 90271365
Hypercholesterolaemia 78.44 9.60 29 140294 100863 90387261
Back pain 77.46 9.60 791 139532 316384 90171740
Gait inability 76.95 9.60 68 140255 146388 90341736
Night sweats 76.23 9.60 53 140270 128713 90359411
Prescribed overdose 76.00 9.60 28 140295 97597 90390527
Pulmonary fibrosis 73.87 9.60 37 140286 107466 90380658
Live birth 71.95 9.60 17 140306 79090 90409034
Illness 70.95 9.60 283 140040 81686 90406438
Constipation 70.72 9.60 704 139619 279691 90208433
Pneumonia haemophilus 70.46 9.60 38 140285 1465 90486659
Dermatitis atopic 67.03 9.60 126 140197 23346 90464778
Throat tightness 65.97 9.60 143 140180 29341 90458783
Gastrointestinal disorder 64.45 9.60 194 140129 256493 90231631
Obesity 64.36 9.60 42 140281 105465 90382659
Throat irritation 61.98 9.60 191 140132 48504 90439620
Exposure during pregnancy 61.44 9.60 178 140145 238232 90249892
Toxicity to various agents 61.08 9.60 234 140089 287612 90200512
Product dose omission issue 60.82 9.60 705 139618 290982 90197142
Blood alkaline phosphatase increased 60.66 9.60 188 140135 47891 90440233
Anaemia 59.22 9.60 819 139504 351983 90136141
Tongue biting 58.14 9.60 38 140285 2095 90486029
Cholecystitis acute 57.65 9.60 72 140251 9332 90478792
Hip arthroplasty 57.42 9.60 23 140300 76185 90411939
Cholecystitis chronic 56.71 9.60 73 140250 9753 90478371
No adverse event 55.88 9.60 231 140092 67751 90420373
Autoimmune disorder 54.89 9.60 25 140298 76719 90411405
Sciatica 54.56 9.60 46 140277 101336 90386788
Blepharospasm 54.37 9.60 10 140313 55435 90432689
Acute respiratory failure 54.31 9.60 168 140155 42750 90445374
Injury 53.32 9.60 144 140179 197205 90290919
Blood urea increased 52.21 9.60 133 140190 30280 90457844
Cough 51.94 9.60 831 139492 368131 90119993
Weight increased 51.58 9.60 407 139916 417520 90070604
Sepsis 51.54 9.60 464 139859 179350 90308774
Blood creatinine increased 50.06 9.60 298 140025 101088 90387036
Intentional overdose 49.97 9.60 43 140280 93791 90394333
Contusion 49.64 9.60 210 140113 251006 90237118
Dyspnoea 49.62 9.60 1746 138577 879209 89608915
Lower limb fracture 48.99 9.60 36 140287 84977 90403147
Mouth haemorrhage 48.82 9.60 63 140260 8438 90479686
Mental status changes 48.51 9.60 166 140157 44513 90443611
Pharyngeal swelling 48.41 9.60 68 140255 9876 90478248
Death 48.29 9.60 983 139340 455568 90032556
Gastritis 47.88 9.60 158 140165 41595 90446529
Knee arthroplasty 46.94 9.60 36 140287 83146 90404978
Cerebral infarction 46.38 9.60 117 140206 26479 90461645
Red blood cell sedimentation rate increased 46.28 9.60 36 140287 82559 90405565
Respiratory failure 46.20 9.60 328 139995 118090 90370034
Infusion related reaction 45.55 9.60 419 139904 416361 90071763
Road traffic accident 44.38 9.60 61 140262 107565 90380559
Wheezing 44.02 9.60 204 140119 237876 90250248
Haemoglobin decreased 43.92 9.60 413 139910 161543 90326581
Upper respiratory tract inflammation 43.88 9.60 35 140288 2637 90485487
Plasma cell myeloma 43.72 9.60 151 140172 40677 90447447
Infection 43.57 9.60 355 139968 361739 90126385
Condition aggravated 43.33 9.60 655 139668 594890 89893234
Red blood cell count decreased 43.33 9.60 164 140159 46187 90441937
Hypoxia 43.21 9.60 224 140099 72175 90415949
Neuropathy peripheral 43.18 9.60 361 139962 136609 90351515
Pregnancy 43.16 9.60 21 140302 62026 90426098
Enterocolitis 42.79 9.60 66 140257 10424 90477700
Peripheral swelling 42.30 9.60 422 139901 412684 90075440
Stomatitis 42.06 9.60 251 140072 274447 90213677
Sleep disorder 41.98 9.60 161 140162 197869 90290255
Lupus-like syndrome 41.55 9.60 12 140311 48834 90439290
Emotional distress 41.38 9.60 138 140185 36524 90451600
Confusional state 40.17 9.60 393 139930 385812 90102312
Exostosis 40.09 9.60 16 140307 53118 90435006
Product dose omission in error 39.80 9.60 94 140229 20409 90467715
Onychomadesis 39.69 9.60 11 140312 45987 90442137
Hypersensitivity 39.20 9.60 483 139840 454194 90033930
Medication error 39.07 9.60 44 140279 84608 90403516
Vitamin B12 increased 39.03 9.60 28 140295 1798 90486326
Mucosal inflammation 38.43 9.60 184 140139 57441 90430683
Overdose 38.28 9.60 121 140202 157588 90330536
Lymphocyte count decreased 37.86 9.60 130 140193 34920 90453204
Joint dislocation 37.84 9.60 11 140312 44571 90443553
Lung disorder 37.80 9.60 113 140210 149770 90338354
Blood immunoglobulin A increased 37.79 9.60 24 140299 1259 90486865
Post cholecystectomy syndrome 37.78 9.60 21 140302 860 90487264
Therapy non-responder 36.73 9.60 100 140223 136604 90351520
Renal impairment 36.02 9.60 283 140040 105138 90382986
Blood pressure decreased 35.61 9.60 218 140105 74677 90413447
Hepatic cirrhosis 34.90 9.60 28 140295 63225 90424899
Sinusitis 34.88 9.60 351 139972 342737 90145387
Prescribed underdose 34.61 9.60 39 140284 74980 90413144
Epilepsy 34.49 9.60 46 140277 82160 90405964
Joint stiffness 34.47 9.60 42 140281 78000 90410124
Blood bilirubin increased 34.38 9.60 146 140177 43324 90444800
Hypokalaemia 34.37 9.60 332 139991 130784 90357340
Coeliac disease 34.37 9.60 13 140310 44597 90443527
Product administration interrupted 34.36 9.60 66 140257 12426 90475698
Frequent bowel movements 34.27 9.60 23 140300 56912 90431212
Therapy interrupted 34.15 9.60 161 140162 49947 90438177
Nail disorder 34.05 9.60 25 140298 59042 90429082
Chills 34.02 9.60 333 139990 131648 90356476
Dysphagia 33.85 9.60 293 140030 111985 90376139
Weight fluctuation 33.52 9.60 86 140237 19663 90468461
Foot deformity 33.42 9.60 26 140297 59625 90428499
Feeling abnormal 33.40 9.60 401 139922 166834 90321290
Pain 33.07 9.60 1236 139087 995105 89493019
Impaired quality of life 32.50 9.60 94 140229 23050 90465074
Foetal exposure during pregnancy 32.32 9.60 13 140310 42962 90445162
Ileus 32.27 9.60 76 140247 16470 90471654
Bone pain 31.76 9.60 184 140139 61799 90426325
Blood albumin decreased 31.50 9.60 76 140247 16727 90471397
Inappropriate schedule of product administration 31.48 9.60 363 139960 149570 90338554
Acute kidney injury 31.28 9.60 682 139641 319705 90168419
Haemolytic anaemia 31.19 9.60 61 140262 11636 90476488
Drug tolerance decreased 31.06 9.60 6 140317 32124 90456000
Dry eye 31.02 9.60 174 140149 57757 90430367
Hypomagnesaemia 30.89 9.60 123 140200 35465 90452659
Adverse event 30.71 9.60 87 140236 117331 90370793
Milk-alkali syndrome 30.66 9.60 21 140302 1252 90486872
Disease progression 30.60 9.60 374 139949 156241 90331883
Decreased appetite 30.49 9.60 781 139542 375759 90112365
Haematocrit decreased 30.42 9.60 137 140186 41695 90446429
Eosinophilic oesophagitis 30.19 9.60 18 140305 843 90487281
Nasopharyngitis 30.17 9.60 446 139877 406658 90081466
Hypervolaemia 29.88 9.60 115 140208 32642 90455482
Walking aid user 29.70 9.60 9 140314 35497 90452627
Nasal congestion 29.64 9.60 226 140097 83188 90404936
Blood magnesium decreased 29.44 9.60 71 140252 15622 90472502
Blood potassium decreased 29.41 9.60 149 140174 47578 90440546
Unresponsive to stimuli 29.35 9.60 127 140196 37994 90450130
Renal injury 29.26 9.60 55 140268 10188 90477936
White blood cell count increased 29.04 9.60 191 140132 67050 90421074
Finger deformity 28.13 9.60 8 140315 32889 90455235
Tongue injury 27.73 9.60 15 140308 582 90487542
Dry mouth 27.72 9.60 169 140154 183890 90304234
Intentional dose omission 27.70 9.60 75 140248 17708 90470416
Hereditary angioedema 27.65 9.60 51 140272 9314 90478810
Myalgia 27.51 9.60 402 139921 174723 90313401
Ulcer haemorrhage 27.47 9.60 4 140319 26317 90461807
Vitamin D deficiency 27.30 9.60 74 140249 17482 90470642
Aspartate aminotransferase 27.23 9.60 16 140307 729 90487395
Osteoporosis 27.15 9.60 69 140254 96462 90391662
Onychomycosis 27.00 9.60 12 140311 37364 90450760
Erythema multiforme 26.94 9.60 59 140264 12187 90475937
Hepatocellular injury 26.77 9.60 6 140317 28952 90459172
Gallbladder disorder 26.44 9.60 79 140244 19724 90468400
Exposure via skin contact 26.36 9.60 54 140269 10651 90477473
Hospice care 26.36 9.60 51 140272 9653 90478471
Tremor 26.22 9.60 357 139966 152816 90335308
Eye irritation 26.01 9.60 113 140210 33865 90454259
Pruritus 25.99 9.60 1055 139268 540470 89947654
Vaccination site reaction 25.91 9.60 11 140312 246 90487878
Haemorrhage subcutaneous 25.78 9.60 29 140294 3367 90484757
Erythema 25.66 9.60 498 139825 228748 90259376
Angioedema 25.47 9.60 180 140143 64696 90423428
Pathergy reaction 25.37 9.60 8 140315 73 90488051
Blood uric acid increased 25.36 9.60 44 140279 7660 90480464
Heart rate increased 25.36 9.60 277 140046 112625 90375499
Intentional self-injury 25.33 9.60 7 140316 29327 90458797
Suicide attempt 25.22 9.60 49 140274 75350 90412774
Oedema 25.16 9.60 194 140129 200101 90288023
Arthritis 25.00 9.60 154 140169 167161 90320963
Granulocyte count increased 24.99 9.60 20 140303 1514 90486610
Hypoalbuminaemia 24.71 9.60 67 140256 15830 90472294
Lymphocyte stimulation test positive 24.67 9.60 13 140310 478 90487646
Rheumatoid factor increased 24.39 9.60 24 140299 2387 90485737
Pulmonary hypertension 24.30 9.60 130 140193 42393 90445731
Altered state of consciousness 24.24 9.60 105 140218 31427 90456697
Lip swelling 24.11 9.60 121 140202 38489 90449635
Dry skin 24.06 9.60 225 140098 87848 90400276
Small intestinal obstruction 24.03 9.60 80 140243 21154 90466970
Renal failure 23.94 9.60 309 140014 130698 90357426
Hepatitis 23.64 9.60 46 140277 70693 90417431
Gastrooesophageal reflux disease 23.49 9.60 375 139948 165962 90322162
Dopamine transporter scintigraphy abnormal 23.26 9.60 8 140315 98 90488026
Electric shock 22.97 9.60 20 140303 1702 90486422
Seasonal allergy 22.89 9.60 83 140240 22900 90465224
Throat clearing 22.86 9.60 29 140294 3818 90484306
Vomiting 22.84 9.60 1463 138860 786830 89701294
Dizziness 22.78 9.60 1123 139200 588161 89899963
Laryngitis 22.75 9.60 27 140296 50726 90437398
Hypophagia 22.71 9.60 113 140210 35824 90452300
SARS-CoV-2 test positive 22.67 9.60 52 140271 11076 90477048
Arthralgia 22.50 9.60 981 139342 777541 89710583
Completed suicide 22.47 9.60 132 140191 144926 90343198
Palpitations 22.32 9.60 316 140007 136412 90351712
Reflux gastritis 22.22 9.60 18 140305 1386 90486738
Idiopathic urticaria 22.22 9.60 11 140312 354 90487770
Pharyngeal inflammation 22.08 9.60 16 140307 1044 90487080
Sinus tachycardia 21.96 9.60 95 140228 28418 90459706
Infusion site swelling 21.96 9.60 53 140270 11667 90476457
Ventricular tachycardia 21.93 9.60 86 140237 24622 90463502
Shock symptom 21.78 9.60 10 140313 271 90487853
Glomerular filtration rate increased 21.77 9.60 21 140302 2039 90486085
Drug resistance 21.64 9.60 10 140313 30439 90457685
Hypersensitivity myocarditis 21.62 9.60 10 140313 276 90487848
Loss of personal independence in daily activities 21.54 9.60 123 140200 135982 90352142
Enterovirus infection 21.46 9.60 18 140305 1456 90486668
Pulmonary oedema 21.39 9.60 167 140156 61913 90426211
Gallbladder injury 21.22 9.60 17 140306 1289 90486835
Rheumatoid nodule 21.20 9.60 3 140320 20163 90467961
Post-traumatic stress disorder 21.19 9.60 38 140285 6790 90481334
Triple negative breast cancer 21.16 9.60 11 140312 393 90487731
Foetal heart rate abnormal 21.13 9.60 15 140308 947 90487177
Infusion site pain 21.13 9.60 73 140250 19665 90468459
Biliary dyskinesia 21.12 9.60 23 140300 2576 90485548
Psoriasis 21.05 9.60 138 140185 147616 90340508
Acute respiratory distress syndrome 20.90 9.60 94 140229 28592 90459532
Drug eruption 20.74 9.60 109 140214 35298 90452826
Amino acid level decreased 20.71 9.60 7 140316 81 90488043
Pleural neoplasm 20.49 9.60 11 140312 420 90487704
Oropharyngeal discomfort 20.22 9.60 40 140283 7695 90480429
Monocyte count increased 20.21 9.60 44 140279 9053 90479071
Maternal exposure timing unspecified 20.11 9.60 5 140318 22478 90465646
Spondylolisthesis 20.04 9.60 28 140295 4047 90484077
Tubulointerstitial nephritis 19.95 9.60 85 140238 25258 90462866
Vitamin B12 deficiency 19.91 9.60 39 140284 7447 90480677
Total lung capacity abnormal 19.90 9.60 7 140316 92 90488032
Hepatotoxicity 19.90 9.60 25 140298 45817 90442307
Back injury 19.64 9.60 26 140297 46596 90441528
Epistaxis 19.64 9.60 210 140113 84915 90403209
Anhedonia 19.63 9.60 50 140273 11381 90476743
Coma 19.60 9.60 53 140270 72579 90415545
Product preparation issue 19.48 9.60 21 140302 2325 90485799
Rebound acid hypersecretion 19.43 9.60 10 140313 350 90487774
Shock 19.27 9.60 92 140231 28686 90459438
Full blood count decreased 19.22 9.60 94 140229 29595 90458529
Autoimmune myocarditis 19.11 9.60 9 140314 259 90487865
Oxygen saturation decreased 19.01 9.60 252 140071 107231 90380893
Thrombosis 18.95 9.60 185 140138 73066 90415058
Pneumothorax 18.90 9.60 69 140254 19098 90469026
Deep vein thrombosis 18.86 9.60 221 140102 91399 90396725
Torsade de pointes 18.81 9.60 59 140264 15123 90473001
Cellulitis 18.66 9.60 220 140103 91117 90397007
Asteatosis 18.63 9.60 6 140317 59 90488065
Liver function test increased 18.61 9.60 68 140255 84787 90403337
Leukocytosis 18.57 9.60 96 140227 30894 90457230
End stage renal disease 18.52 9.60 41 140282 8530 90479594
Pleural effusion 18.34 9.60 259 140064 111732 90376392
C-reactive protein increased 18.24 9.60 186 140137 181203 90306921
Hyponatraemia 18.09 9.60 299 140024 133239 90354885
Device expulsion 18.06 9.60 22 140301 40864 90447260
Cerebral haemorrhage 18.02 9.60 103 140220 34419 90453705
Temperature intolerance 18.00 9.60 50 140273 11980 90476144
Impaired gastric emptying 17.96 9.60 52 140271 12757 90475367
Insurance issue 17.86 9.60 47 140276 10911 90477213
Gastrointestinal haemorrhage 17.83 9.60 216 140107 90032 90398092
Colitis 17.78 9.60 176 140147 69766 90418358
Myelosuppression 17.77 9.60 35 140288 53556 90434568
Cytomegalovirus enterocolitis 17.77 9.60 13 140310 861 90487263
Hypophosphataemia 17.74 9.60 57 140266 14797 90473327
Blindness transient 17.72 9.60 28 140295 4515 90483609
Pancytopenia 17.69 9.60 273 140050 119990 90368134
Cerebrovascular accident 17.63 9.60 279 140044 123254 90364870
Hypochloraemia 17.57 9.60 21 140302 2601 90485523
Pyrexia 17.53 9.60 1217 139106 659268 89828856
Surgery 17.30 9.60 124 140199 44763 90443361
Macular degeneration 17.23 9.60 20 140303 37950 90450174
SJS-TEN overlap 17.11 9.60 14 140309 1094 90487030
Glycosylated haemoglobin increased 17.05 9.60 58 140265 15504 90472620
Atrioventricular block complete 16.94 9.60 43 140280 9768 90478356
Cholelithiasis 16.86 9.60 139 140184 52367 90435757
Burkholderia test positive 16.80 9.60 8 140315 236 90487888
Blood pressure diastolic abnormal 16.70 9.60 5 140318 19876 90468248
Tendon injury 16.69 9.60 19 140304 2234 90485890
Encephalopathy 16.59 9.60 126 140197 46318 90441806
Adverse reaction 16.58 9.60 13 140310 29699 90458425
Protein total decreased 16.57 9.60 35 140288 7054 90481070
Postural orthostatic tachycardia syndrome 16.56 9.60 19 140304 2253 90485871
Intercepted product storage error 16.53 9.60 10 140313 481 90487643
Pneumonitis 16.44 9.60 121 140202 44049 90444075
Ehlers-Danlos syndrome 16.27 9.60 9 140314 365 90487759
Carcinoembryonic antigen 16.22 9.60 6 140317 92 90488032
Blood sodium decreased 16.17 9.60 85 140238 27528 90460596
Early satiety 16.12 9.60 15 140308 1392 90486732
Bacteriuria 16.07 9.60 14 140309 1192 90486932
Neutrophil count increased 16.02 9.60 66 140257 19324 90468800
Extensor plantar response 15.94 9.60 15 140308 1412 90486712
Respiratory alkalosis 15.93 9.60 23 140300 3425 90484699
Infusion site erythema 15.91 9.60 52 140271 13618 90474506
Carbohydrate antigen 15-3 15.87 9.60 6 140317 98 90488026
Intentional product misuse 15.83 9.60 78 140245 89526 90398598
Rhinovirus infection 15.78 9.60 31 140292 5932 90482192
Drug clearance decreased 15.78 9.60 17 140306 1881 90486243
Subdural haematoma 15.64 9.60 59 140264 16586 90471538
Adverse drug reaction 15.62 9.60 111 140212 116590 90371534
Infusion site pruritus 15.35 9.60 33 140290 6732 90481392
Ovarian cancer 15.34 9.60 33 140290 6734 90481390
Colitis ischaemic 15.31 9.60 48 140275 12298 90475826
Reticulocyte percentage increased 15.28 9.60 4 140319 17 90488107
Premature baby 15.27 9.60 10 140313 25067 90463057
Breast adenoma 15.10 9.60 5 140318 54 90488070
Eye discharge 15.10 9.60 37 140286 8221 90479903
Gastric ulcer 15.06 9.60 83 140240 27365 90460759
Pustular psoriasis 14.99 9.60 5 140318 18551 90469573
Cytokine release syndrome 14.96 9.60 84 140239 27889 90460235
Vision blurred 14.95 9.60 247 140076 110046 90378078
Platelet transfusion 14.92 9.60 13 140310 1107 90487017
Atelectasis 14.89 9.60 76 140247 24333 90463791
Device related infection 14.84 9.60 79 140244 25707 90462417
Hyperglycaemia 14.83 9.60 132 140191 50838 90437286
Poikiloderma 14.80 9.60 8 140315 310 90487814
Eye haematoma 14.71 9.60 6 140317 121 90488003
Pelvic abscess 14.65 9.60 17 140306 2041 90486083
Mechanical urticaria 14.63 9.60 10 140313 594 90487530
Chronic spontaneous urticaria 14.60 9.60 16 140307 1804 90486320
Putamen haemorrhage 14.59 9.60 7 140316 210 90487914
Flashback 14.59 9.60 8 140315 319 90487805
Hypertension 14.57 9.60 570 139753 456962 90031162
Hyperlipidaemia 14.44 9.60 72 140251 22844 90465280
Cardiac disorder 14.40 9.60 143 140180 56729 90431395
Dermatitis contact 14.31 9.60 50 140273 13545 90474579
Muscle contractions involuntary 14.22 9.60 20 140303 2908 90485216
Neutropenia 14.16 9.60 452 139871 224452 90263672
Respiratory distress 14.10 9.60 106 140217 38840 90449284
Parenteral nutrition 14.09 9.60 7 140316 227 90487897
Colitis ulcerative 14.09 9.60 47 140276 60219 90427905
Blood pressure abnormal 14.03 9.60 64 140259 19581 90468543
Blood glucose increased 13.92 9.60 216 140107 95030 90393094
Dizziness postural 13.92 9.60 38 140285 9015 90479109
Neuralgia 13.92 9.60 90 140233 31410 90456714
Blood creatine phosphokinase MB increased 13.86 9.60 13 140310 1219 90486905
Dyspnoea exertional 13.84 9.60 172 140151 72116 90416008
Heliotrope rash 13.79 9.60 7 140316 238 90487886
Oesophageal motility disorder 13.75 9.60 10 140313 656 90487468
Haematuria 13.75 9.60 97 140226 34840 90453284
Pneumonia 13.65 9.60 1156 139167 636903 89851221
Tooth extraction 13.58 9.60 44 140279 11469 90476655
Concomitant disease aggravated 13.57 9.60 44 140279 11474 90476650
Joint noise 13.40 9.60 27 140296 5263 90482861
Carbon dioxide decreased 13.37 9.60 19 140304 2789 90485335
Cholinergic syndrome 13.36 9.60 10 140313 686 90487438
Oxygen therapy 13.33 9.60 20 140303 3082 90485042
Dermatitis acneiform 13.29 9.60 30 140293 6324 90481800
Memory impairment 13.27 9.60 220 140103 197024 90291100
Hyperuricaemia 13.25 9.60 31 140292 6688 90481436
Dysgeusia 13.23 9.60 132 140191 52428 90435696
Respiratory syncytial virus infection 13.23 9.60 41 140282 10439 90477685
Skin exfoliation 13.18 9.60 162 140161 67751 90420373
Neurosurgery 13.04 9.60 5 140318 85 90488039
Foetal death 12.98 9.60 8 140315 20715 90467409
Palmar-plantar erythrodysaesthesia syndrome 12.96 9.60 81 140242 27942 90460182
Sedation complication 12.95 9.60 5 140318 16939 90471185
Pityriasis lichenoides et varioliformis acuta 12.94 9.60 4 140319 34 90488090
Immunodeficiency 12.87 9.60 30 140293 43204 90444920
Oropharyngeal pain 12.80 9.60 250 140073 114937 90373187
Ovarian cancer recurrent 12.80 9.60 14 140309 1576 90486548
Anaphylactoid reaction 12.77 9.60 24 140299 4444 90483680
Underdose 12.71 9.60 42 140281 53975 90434149
Muscle spasticity 12.66 9.60 22 140301 35300 90452824
Bronchitis 12.59 9.60 318 140005 152609 90335515
Pneumonia bacterial 12.57 9.60 46 140277 12744 90475380
Ascites 12.56 9.60 121 140202 47619 90440505
Coronary artery disease 12.45 9.60 92 140231 33531 90454593
Mean arterial pressure increased 12.45 9.60 4 140319 39 90488085
Blood pressure systolic decreased 12.39 9.60 37 140286 9233 90478891
Pulmonary embolism 12.28 9.60 277 140046 130543 90357581
Surfactant protein increased 12.27 9.60 3 140320 9 90488115
Creatinine renal clearance decreased 12.25 9.60 7 140316 18892 90469232
Incorrect route of product administration 12.17 9.60 39 140284 50587 90437537
Seizure 12.16 9.60 316 140007 152313 90335811
Human chorionic gonadotropin decreased 12.11 9.60 5 140318 104 90488020
Acute myocardial infarction 12.10 9.60 94 140229 34796 90453328
Normal newborn 12.08 9.60 11 140312 23351 90464773
Transfusion-associated dyspnoea 12.02 9.60 4 140319 44 90488080
Gastroenteritis 12 9.60 82 140241 29147 90458977
Hypertonic bladder 11.99 9.60 23 140300 4325 90483799
Cardiac failure 11.95 9.60 237 140086 109259 90378865
Stevens-Johnson syndrome 11.82 9.60 82 140241 29294 90458830
General symptom 11.77 9.60 4 140319 14664 90473460
Burning sensation 11.73 9.60 150 140173 63302 90424822
Muscle atrophy 11.68 9.60 34 140289 8367 90479757
Compression fracture 11.67 9.60 35 140288 8754 90479370
Eye pruritus 11.66 9.60 81 140242 28946 90459178
Temperature regulation disorder 11.65 9.60 4 140319 14575 90473549
Failure to thrive 11.65 9.60 34 140289 8377 90479747
Blood glucose decreased 11.64 9.60 69 140254 23360 90464764
Ingrowing nail 11.64 9.60 18 140305 2849 90485275
Tenosynovitis 11.64 9.60 4 140319 14563 90473561
Peptic ulcer 11.62 9.60 26 140297 5449 90482675
Infusion related hypersensitivity reaction 11.58 9.60 9 140314 653 90487471
Eczema 11.54 9.60 129 140194 52741 90435383
Cluster headache 11.52 9.60 10 140313 847 90487277
Cystitis haemorrhagic 11.50 9.60 26 140297 5487 90482637
Malnutrition 11.47 9.60 58 140265 18500 90469624
Anaphylactic shock 11.42 9.60 86 140237 31531 90456593
Anaplastic astrocytoma 11.34 9.60 4 140319 53 90488071
Dactylitis 11.32 9.60 21 140302 3852 90484272
Urine output decreased 11.29 9.60 44 140279 12559 90475565
Aspartate aminotransferase abnormal 11.27 9.60 17 140306 2632 90485492
Thrombocytopenia 11.25 9.60 412 139911 208313 90279811
Ammonia decreased 11.23 9.60 3 140320 14 90488110
Vulvovaginal candidiasis 11.21 9.60 21 140302 3879 90484245
Device infusion issue 11.21 9.60 17 140306 2645 90485479
Off label use 11.20 9.60 1516 138807 1100736 89387388
Heart rate abnormal 11.18 9.60 27 140296 5944 90482180
Sensation of foreign body 11.09 9.60 28 140295 6338 90481786
Therapeutic hypothermia 11.06 9.60 3 140320 15 90488109
Cranial nerve disorder 11.06 9.60 9 140314 698 90487426
Transfusion 11.06 9.60 55 140268 17433 90470691
Gastric ulcer haemorrhage 11.02 9.60 25 140298 5286 90482838
Therapy cessation 11.01 9.60 95 140228 36266 90451858
Red blood cell schistocytes present 11.01 9.60 7 140316 368 90487756
Lip pruritus 10.99 9.60 12 140311 1348 90486776
Abdominal pain 10.98 9.60 732 139591 394989 90093135
Pneumocystis jirovecii pneumonia 10.96 9.60 64 140259 21552 90466572
Flatulence 10.96 9.60 105 140218 41262 90446862
Cholestasis 10.95 9.60 25 140298 36274 90451850
Carotid artery stenosis 10.95 9.60 25 140298 5309 90482815
Serum amyloid A protein increased 10.95 9.60 9 140314 708 90487416
Malignant neoplasm progression 10.89 9.60 229 140094 106641 90381483
Proctitis 10.86 9.60 5 140318 15254 90472870
Respiration abnormal 10.85 9.60 32 140291 7931 90480193
Haemodialysis 10.84 9.60 34 140289 8713 90479411
Vascular resistance systemic decreased 10.81 9.60 5 140318 138 90487986
Glucose tolerance impaired 10.80 9.60 32 140291 7953 90480171
Dermatomyositis 10.77 9.60 19 140304 3351 90484773
Metapneumovirus pneumonia 10.77 9.60 4 140319 62 90488062
Hypergeusia 10.75 9.60 3 140320 17 90488107
COVID-19 pneumonia 10.68 9.60 56 140267 18121 90470003
Oesophageal injury 10.66 9.60 4 140319 64 90488060
Transferrin decreased 10.63 9.60 7 140316 391 90487733
Cholecystectomy 10.50 9.60 41 140282 11714 90476410
Tachycardia 10.48 9.60 319 140004 157354 90330770
Hydroureter 10.47 9.60 8 140315 566 90487558
Bile duct stone 10.45 9.60 21 140302 4086 90484038
Restless arm syndrome 10.43 9.60 4 140319 68 90488056
Calculus urinary 10.41 9.60 13 140310 1685 90486439
Gamma-glutamyltransferase increased 10.39 9.60 97 140226 37855 90450269
Antimitochondrial antibody positive 10.33 9.60 4 140319 70 90488054
Ear discomfort 10.30 9.60 37 140286 10163 90477961
Hypernatraemia 10.30 9.60 35 140288 9352 90478772
Proctalgia 10.28 9.60 32 140291 8166 90479958
Polyarthritis 10.27 9.60 8 140315 18342 90469782
Oedema mucosal 10.25 9.60 11 140312 1212 90486912
Blood potassium increased 10.24 9.60 61 140262 20688 90467436
Blindness cortical 10.21 9.60 8 140315 587 90487537
Intestinal obstruction 10.21 9.60 95 140228 37036 90451088
Allergic reaction to excipient 10.21 9.60 9 140314 779 90487345
Amnesia 10.20 9.60 113 140210 108392 90379732
Amylase increased 10.20 9.60 29 140294 7043 90481081
Hypoparathyroidism 10.19 9.60 10 140313 991 90487133
Dementia Alzheimer's type 10.19 9.60 10 140313 991 90487133
Drug-induced liver injury 10.19 9.60 90 140233 90228 90397896
Thyroglobulin increased 10.17 9.60 4 140319 73 90488051
Cell marker increased 10.14 9.60 6 140317 277 90487847
Disability 10.06 9.60 31 140292 40714 90447410
Brain natriuretic peptide increased 10.04 9.60 26 140297 5979 90482145
Cockroach allergy 10.02 9.60 4 140319 76 90488048
Autoimmune haemolytic anaemia 10.01 9.60 25 140298 5620 90482504
Fibrin degradation products increased 10.01 9.60 5 140318 164 90487960
Urinary tract infection staphylococcal 9.98 9.60 7 140316 434 90487690
Musculoskeletal chest pain 9.97 9.60 67 140256 23683 90464441
Therapeutic response unexpected 9.97 9.60 63 140260 21817 90466307
Post procedural fever 9.96 9.60 7 140316 435 90487689
Cholangitis acute 9.95 9.60 8 140315 610 90487514
Lethargy 9.93 9.60 145 140178 62994 90425130
Heparin-induced thrombocytopenia 9.93 9.60 24 140299 5288 90482836
Pulse absent 9.90 9.60 26 140297 6029 90482095
Product quality issue 9.88 9.60 77 140246 79248 90408876
Product prescribing issue 9.88 9.60 31 140292 7948 90480176
Cerebral disorder 9.87 9.60 25 140298 5669 90482455
Haptoglobin decreased 9.85 9.60 10 140313 1033 90487091
Injection site reaction 9.85 9.60 93 140230 91987 90396137
Oesophageal candidiasis 9.84 9.60 28 140295 6801 90481323
Arteriosclerosis 9.81 9.60 38 140285 10815 90477309
Infusion site reaction 9.80 9.60 9 140314 19030 90469094
Drug tolerance 9.79 9.60 8 140315 17908 90470216
Spinal compression fracture 9.78 9.60 48 140275 15130 90472994
Oropharyngeal spasm 9.78 9.60 6 140317 296 90487828
Eye pain 9.74 9.60 108 140215 44060 90444064
Oral discomfort 9.72 9.60 37 140286 10446 90477678
Muscle necrosis 9.67 9.60 9 140314 835 90487289
Cholecystitis 9.67 9.60 52 140271 16988 90471136
Stenotrophomonas test positive 9.65 9.60 3 140320 26 90488098
Injection site swelling 9.64 9.60 138 140185 59701 90428423
Rash macular 9.64 9.60 80 140243 30200 90457924
Iron binding capacity total decreased 9.63 9.60 7 140316 459 90487665

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
Hepatic function abnormal 206.61 10.21 377 87608 51190 42482160
Drug ineffective 169.81 10.21 699 87286 629498 41903852
Drug abuse 148.89 10.21 20 87965 104751 42428599
Toxicity to various agents 142.33 10.21 158 87827 228978 42304372
Aspartate aminotransferase increased 133.50 10.21 406 87579 76757 42456593
Platelet count decreased 124.41 10.21 591 87394 137990 42395360
Alanine aminotransferase increased 123.96 10.21 433 87552 87973 42445377
Aplastic anaemia 115.28 10.21 135 87850 12249 42521101
Disseminated intravascular coagulation 96.38 10.21 179 87806 24615 42508735
Liver disorder 95.92 10.21 236 87749 39408 42493942
Completed suicide 80.17 10.21 50 87935 96415 42436935
White blood cell count decreased 79.61 10.21 443 87542 109953 42423397
Blood lactate dehydrogenase increased 66.00 10.21 158 87827 25923 42507427
Neutrophil count decreased 63.15 10.21 279 87706 63136 42470214
General physical health deterioration 58.51 10.21 142 87843 151104 42382246
Therapeutic product effect incomplete 57.25 10.21 38 87947 70901 42462449
Pyrexia 55.45 10.21 1130 86855 392912 42140438
Intentional overdose 54.57 10.21 19 87966 51437 42481913
Off label use 54.41 10.21 960 87025 637375 41895975
Intentional product misuse 52.93 10.21 31 87954 61869 42471481
Monocyte chemotactic protein-1 increased 52.81 10.21 22 87963 346 42533004
Treatment failure 52.65 10.21 32 87953 62592 42470758
Alpha tumour necrosis factor increased 52.53 10.21 22 87963 351 42532999
Anaphylactic reaction 48.73 10.21 196 87789 42547 42490803
Cerebral infarction 48.33 10.21 158 87827 31011 42502339
Interstitial lung disease 47.61 10.21 301 87684 78161 42455189
Chronic kidney disease 47.14 10.21 208 87777 47033 42486317
Upper respiratory tract inflammation 43.42 10.21 34 87951 1862 42531488
Infusion related reaction 42.46 10.21 242 87743 60564 42472786
Cytokine release syndrome 42.14 10.21 193 87792 44334 42489016
Mechanical ventilation complication 41.97 10.21 23 87962 681 42532669
Interleukin level increased 41.59 10.21 25 87960 885 42532465
Lymphocyte stimulation test positive 41.20 10.21 22 87963 618 42532732
Febrile neutropenia 40.86 10.21 573 87412 185130 42348220
Drug resistance 39.25 10.21 11 87974 34237 42499113
Drug intolerance 39.20 10.21 66 87919 80358 42452992
Pneumonia 39.19 10.21 1144 86841 421005 42112345
Intentional product use issue 38.79 10.21 55 87930 71778 42461572
Drug interaction 37.62 10.21 361 87624 266638 42266712
Blood alkaline phosphatase increased 35.88 10.21 151 87834 33446 42499904
Flushing 35.41 10.21 161 87824 36867 42496483
No adverse event 34.63 10.21 166 87819 38855 42494495
Administration site inflammation 33.71 10.21 10 87975 52 42533298
Product use in unapproved indication 32.97 10.21 234 87751 184222 42349128
Enterocolitis 32.87 10.21 67 87918 9862 42523488
Pneumonia aspiration 32.81 10.21 196 87789 49882 42483468
Foetal exposure during pregnancy 31.12 10.21 31 87954 47280 42486070
Decreased appetite 30.48 10.21 564 87421 192573 42340777
Respiratory failure 30.05 10.21 400 87585 127732 42405618
Blood urea increased 29.45 10.21 140 87845 32653 42500697
Suicide attempt 29.42 10.21 31 87954 46069 42487281
Blood creatine phosphokinase MB increased 28.18 10.21 27 87958 1943 42531407
Psychotic disorder 27.36 10.21 13 87972 29195 42504155
White blood cell count increased 27.35 10.21 173 87812 44914 42488436
Lower respiratory tract infection 27.10 10.21 27 87958 41179 42492171
Salmonella bacteraemia 27.02 10.21 15 87970 456 42532894
Overdose 26.70 10.21 119 87866 105145 42428205
Musculoskeletal stiffness 26.70 10.21 49 87936 57716 42475634
Burkholderia test positive 26.61 10.21 20 87965 1030 42532320
Troponin I increased 25.53 10.21 32 87953 3114 42530236
Pneumothorax 25.28 10.21 106 87879 23437 42509913
Loss of personal independence in daily activities 25.09 10.21 40 87945 49776 42483574
Plasma cell myeloma 24.91 10.21 176 87809 47402 42485948
Obstructive airways disorder 24.81 10.21 10 87975 24749 42508601
Acute respiratory failure 24.76 10.21 151 87834 38707 42494643
Blood pressure ambulatory increased 23.41 10.21 8 87977 70 42533280
Rheumatoid arthritis 23.40 10.21 32 87953 42408 42490942
Haematocrit decreased 23.10 10.21 137 87848 34771 42498579
Urticaria 23.03 10.21 244 87741 73792 42459558
Stomatitis 22.85 10.21 180 87805 50149 42483201
Cardiogenic shock 22.70 10.21 24 87961 35616 42497734
Hyperuricaemia 22.67 10.21 56 87929 9368 42523982
Constipation 22.56 10.21 465 87520 161826 42371524
Adverse reaction 22.43 10.21 34 87951 3959 42529391
Hypoxia 22.18 10.21 231 87754 69555 42463795
Aggression 21.73 10.21 36 87949 44127 42489223
Blood bilirubin increased 21.37 10.21 155 87830 42097 42491253
Prohormone brain natriuretic peptide increased 21.16 10.21 8 87977 96 42533254
Hospice care 20.92 10.21 51 87934 8462 42524888
Myelosuppression 20.84 10.21 32 87953 40429 42492921
Somnolence 20.59 10.21 189 87796 140916 42392434
Pleural effusion 19.82 10.21 296 87689 96870 42436480
Hypoalbuminaemia 19.75 10.21 74 87911 15536 42517814
Cardiac autonomic neuropathy 19.66 10.21 7 87978 70 42533280
Torsade de pointes 19.55 10.21 50 87935 8544 42524806
Pneumonia bacterial 19.54 10.21 74 87911 15618 42517732
Coma 19.35 10.21 52 87933 53502 42479848
Catheter site haemorrhage 19.23 10.21 25 87960 2523 42530827
Orthostatic hypertension 18.88 10.21 12 87973 470 42532880
Gastric perforation 18.32 10.21 27 87958 3066 42530284
Frequent bowel movements 17.90 10.21 11 87974 21396 42511954
Post procedural complication 17.90 10.21 62 87923 12528 42520822
Condition aggravated 17.60 10.21 407 87578 260347 42273003
Dermatitis atopic 17.56 10.21 61 87924 12343 42521007
Gamma-glutamyltransferase increased 17.47 10.21 121 87864 32376 42500974
Pneumonia staphylococcal 17.30 10.21 28 87957 3448 42529902
Renal impairment 17.05 10.21 321 87664 109907 42423443
Psoriasis 16.96 10.21 48 87937 48556 42484794
Gastroenteritis salmonella 16.54 10.21 13 87972 716 42532634
Serum amyloid A protein increased 16.53 10.21 9 87976 263 42533087
Cavernous sinus syndrome 16.26 10.21 5 87980 30 42533320
Disease prodromal stage 16.12 10.21 5 87980 31 42533319
Supine hypertension 16.12 10.21 10 87975 375 42532975
Full blood count abnormal 16.00 10.21 23 87962 29853 42503497
Pulmonary fibrosis 15.86 10.21 19 87966 26662 42506688
Therapy partial responder 15.78 10.21 11 87974 20010 42513340
Suicidal ideation 15.77 10.21 49 87936 48112 42485238
Blood pressure decreased 15.75 10.21 187 87798 58145 42475205
Sepsis 15.71 10.21 530 87455 198804 42334546
Blood albumin decreased 15.50 10.21 68 87917 15334 42518016
Intentional self-injury 15.46 10.21 6 87979 15196 42518154
Rash 15.19 10.21 708 87277 276246 42257104
Disturbance in attention 15.02 10.21 24 87961 29842 42503508
Hepatocellular injury 15.02 10.21 16 87969 23662 42509688
Mucosal inflammation 15.01 10.21 162 87823 49212 42484138
Drug dependence 14.99 10.21 23 87962 29071 42504279
Cognitive disorder 14.90 10.21 30 87955 34142 42499208
Blood creatinine increased 14.89 10.21 314 87671 109689 42423661
Ventricular tachycardia 14.88 10.21 110 87875 30050 42503300
Mast cell activation syndrome 14.71 10.21 9 87976 329 42533021
Haemothorax 14.64 10.21 33 87952 5203 42528147
Haemoglobin decreased 14.48 10.21 367 87618 132104 42401246
Cholestasis 14.22 10.21 29 87956 32850 42500500
Amino acid level decreased 14.15 10.21 7 87978 167 42533183
Cerebral haemorrhage 13.83 10.21 132 87853 38834 42494516
Arthropathy 13.77 10.21 25 87960 29572 42503778
Oral dysaesthesia 13.67 10.21 6 87979 108 42533242
Nightmare 13.65 10.21 19 87966 24993 42508357
Burkholderia infection 13.62 10.21 6 87979 109 42533241
Haematotoxicity 13.61 10.21 3 87982 10982 42522368
Inspiratory capacity decreased 13.56 10.21 23 87962 2944 42530406
Amino acid level increased 13.51 10.21 10 87975 503 42532847
Stevens-Johnson syndrome 13.39 10.21 85 87900 22093 42511257
Hallucination, auditory 13.34 10.21 7 87978 14857 42518493
Hiccups 13.22 10.21 55 87930 12116 42521234
Rash maculo-papular 13.11 10.21 37 87948 37466 42495884
Synovitis 13.02 10.21 8 87977 15559 42517791
Complement factor decreased 13.01 10.21 4 87981 24 42533326
Angiopathy 12.98 10.21 32 87953 5345 42528005
Cholangitis acute 12.95 10.21 14 87971 1163 42532187
Extravasation 12.93 10.21 20 87965 2370 42530980
Lymphocyte count decreased 12.92 10.21 100 87885 27709 42505641
Lung disorder 12.86 10.21 53 87932 47870 42485480
Sputum culture positive 12.82 10.21 17 87968 1749 42531601
Mouth haemorrhage 12.79 10.21 35 87950 6226 42527124
Chills 12.56 10.21 268 87717 93798 42439552
Polyneuropathy 12.53 10.21 12 87973 18649 42514701
Erythema multiforme 12.38 10.21 47 87938 9930 42523420
Eczema asteatotic 12.31 10.21 9 87976 444 42532906
Blood pressure fluctuation 12.27 10.21 23 87962 26885 42506465
Febrile bone marrow aplasia 12.18 10.21 3 87982 10178 42523172
Inappropriate schedule of product administration 12.09 10.21 133 87852 95769 42437581
Cytomegalovirus infection reactivation 12.07 10.21 4 87981 11174 42522176
Contraindicated product administered 12.07 10.21 21 87964 25251 42508099
Ischaemic stroke 12.02 10.21 17 87968 22216 42511134
Impaired work ability 11.92 10.21 5 87980 12086 42521264
Stress 11.80 10.21 49 87936 44163 42489187
Withdrawal syndrome 11.80 10.21 8 87977 14767 42518583
Blood creatine phosphokinase increased 11.77 10.21 152 87833 48186 42485164
Neutrophil percentage decreased 11.71 10.21 8 87977 354 42532996
Intentional dose omission 11.71 10.21 43 87942 8943 42524407
Poisoning 11.68 10.21 8 87977 14691 42518659
Dyslalia 11.63 10.21 10 87975 625 42532725
Weight increased 11.62 10.21 155 87830 107828 42425522
Necrotising myositis 11.56 10.21 13 87972 1128 42532222
Dystonia 11.52 10.21 6 87979 12784 42520566
Bulbospinal muscular atrophy congenital 11.51 10.21 4 87981 37 42533313
Mobility decreased 11.50 10.21 36 87949 35270 42498080
Ammonia decreased 11.42 10.21 3 87982 9 42533341
Human ehrlichiosis 11.40 10.21 9 87976 499 42532851
Parenteral nutrition 11.30 10.21 10 87975 650 42532700
Ventricular flutter 11.29 10.21 5 87980 92 42533258
Anal erosion 11.23 10.21 4 87981 40 42533310
Nodule 11.11 10.21 6 87979 12528 42520822
Product use issue 11.10 10.21 103 87882 76648 42456702
Blood potassium decreased 11.02 10.21 76 87909 20308 42513042
Progressive multifocal leukoencephalopathy 11.01 10.21 5 87980 11531 42521819
Drug reaction with eosinophilia and systemic symptoms 11.00 10.21 47 87938 42028 42491322
Inappropriate antidiuretic hormone secretion 10.99 10.21 65 87920 16476 42516874
Chest tube insertion 10.96 10.21 5 87980 99 42533251
Sputum retention 10.93 10.21 10 87975 679 42532671
Rhinovirus infection 10.88 10.21 34 87951 6514 42526836
Post procedural haematoma 10.82 10.21 15 87970 1610 42531740
Essential hypertension 10.82 10.21 24 87961 3744 42529606
Pneumonia respiratory syncytial viral 10.71 10.21 14 87971 1420 42531930
Delirium 10.70 10.21 160 87825 52359 42480991
Tracheal haemorrhage 10.64 10.21 9 87976 550 42532800
Face oedema 10.61 10.21 56 87929 13610 42519740
Toxic encephalopathy 10.55 10.21 35 87950 6918 42526432
Bronchiectasis 10.53 10.21 13 87972 18006 42515344
Vertigo 10.51 10.21 36 87949 34311 42499039
Vascular device infection 10.41 10.21 32 87953 6078 42527272
Post transplant lymphoproliferative disorder 10.32 10.21 3 87982 9117 42524233
Urine osmolarity decreased 10.29 10.21 4 87981 52 42533298
Aortic rupture 10.27 10.21 5 87980 115 42533235
Red blood cell count decreased 10.25 10.21 108 87877 32607 42500743
Iron deficiency 10.24 10.21 5 87980 11056 42522294
Meningism 10.23 10.21 6 87979 203 42533147
Empyema 10.22 10.21 25 87960 4155 42529195
Blood pressure systolic increased 10.22 10.21 27 87958 27941 42505409

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
Synovitis 384.33 9.55 19 186990 274073 110128217
Hepatic function abnormal 360.15 9.55 586 186423 88709 110313581
Pemphigus 345.80 9.55 3 187006 214567 110187723
Hand deformity 335.09 9.55 7 187002 218499 110183791
Platelet count decreased 308.86 9.55 974 186035 229469 110172821
Arthropathy 290.89 9.55 65 186944 287457 110114833
Aplastic anaemia 279.46 9.55 270 186739 24038 110378252
Contraindicated product administered 276.96 9.55 44 186965 248223 110154067
Drug ineffective 276.44 9.55 1481 185528 1519059 108883231
Systemic lupus erythematosus 268.61 9.55 52 186957 254286 110148004
Joint swelling 261.36 9.55 219 186790 442626 109959664
Pericarditis 260.46 9.55 32 186977 219082 110183208
Duodenal ulcer perforation 260.15 9.55 9 187000 177691 110224599
Drug intolerance 257.65 9.55 187 186822 406325 109995965
Treatment failure 249.54 9.55 79 186930 277155 110125135
Glossodynia 248.40 9.55 39 186970 221965 110180325
Lower respiratory tract infection 245.81 9.55 55 186954 243051 110159239
Helicobacter infection 241.56 9.55 17 186992 181860 110220430
Aspartate aminotransferase increased 235.68 9.55 699 186310 159237 110243053
Folliculitis 224.61 9.55 15 186994 167638 110234652
Alanine aminotransferase increased 218.54 9.55 746 186263 183027 110219263
General physical health deterioration 217.51 9.55 239 186770 425056 109977234
Muscle injury 210.17 9.55 6 187003 140801 110261489
Therapeutic product effect decreased 207.09 9.55 77 186932 244239 110158051
Wound 207.09 9.55 69 186940 234368 110167922
Drug abuse 205.80 9.55 28 186981 177383 110224907
Flushing 205.74 9.55 509 186500 104227 110298063
Anaphylactic reaction 197.20 9.55 529 186480 113771 110288519
C-reactive protein abnormal 191.85 9.55 6 187003 129689 110272601
White blood cell count decreased 181.46 9.55 819 186190 228571 110173719
Rheumatoid arthritis 179.35 9.55 146 186863 299467 110102823
Psoriatic arthropathy 173.61 9.55 58 186951 196703 110205587
Febrile neutropenia 173.23 9.55 1020 185989 315747 110086543
Disseminated intravascular coagulation 171.93 9.55 275 186734 41011 110361279
Mobility decreased 165.53 9.55 98 186911 237324 110164966
Toxicity to various agents 163.37 9.55 356 186653 480199 109922091
Fibromyalgia 158.63 9.55 46 186963 170863 110231427
Irritable bowel syndrome 152.78 9.55 44 186965 164171 110238119
Sleep disorder due to general medical condition, insomnia type 149.05 9.55 7 187002 105636 110296654
Musculoskeletal stiffness 144.35 9.55 156 186853 279666 110122624
Therapeutic product effect incomplete 142.93 9.55 102 186907 223703 110178587
Liver injury 142.35 9.55 39 186970 150374 110251916
Impaired healing 140.25 9.55 79 186930 196638 110205652
Facet joint syndrome 137.97 9.55 6 187003 96822 110305468
Hepatic enzyme increased 136.45 9.55 207 186802 320685 110081605
Blood lactate dehydrogenase increased 134.68 9.55 257 186752 44077 110358213
Cytokine release syndrome 130.02 9.55 334 186675 69972 110332318
Neutrophil count decreased 129.98 9.55 475 186534 120466 110281824
Maternal exposure during pregnancy 127.18 9.55 146 186863 254737 110147553
Joint range of motion decreased 126.29 9.55 26 186983 121806 110280484
Interstitial lung disease 121.19 9.55 512 186497 138822 110263468
Type 2 diabetes mellitus 119.56 9.55 76 186933 177156 110225134
Bursitis 118.67 9.55 36 186973 129882 110272408
Breast cancer stage III 115.79 9.55 4 187005 79113 110323177
Ill-defined disorder 114.70 9.55 61 186948 156792 110245498
Intentional product use issue 112.19 9.55 153 186856 247753 110154537
Lip dry 110.97 9.55 18 186991 100065 110302225
Drug hypersensitivity 105.42 9.55 403 186606 453687 109948603
Respiratory syncytial virus test positive 104.79 9.55 51 186958 1443 110400847
Swelling 104.23 9.55 279 186730 350762 110051528
Grip strength decreased 102.21 9.55 9 187000 80165 110322125
Blood cholesterol increased 102.13 9.55 97 186912 184688 110217602
Human rhinovirus test positive 100.65 9.55 47 186962 1210 110401080
Inflammation 98.23 9.55 109 186900 193129 110209161
Peripheral venous disease 98.19 9.55 13 186996 84104 110318186
Musculoskeletal pain 97.77 9.55 99 186910 182924 110219366
No adverse event 96.85 9.55 310 186699 73529 110328761
Blister 96.31 9.55 147 186862 227229 110175061
Product use issue 96.15 9.55 243 186766 311452 110090838
Cerebral infarction 94.54 9.55 245 186764 51593 110350697
Alopecia 91.73 9.55 313 186696 364440 110037850
Intentional overdose 90.49 9.55 56 186953 132445 110269845
Chest discomfort 87.43 9.55 548 186461 173300 110228990
Dehydration 87.18 9.55 787 186222 278724 110123566
Type I hypersensitivity 86.96 9.55 78 186931 6315 110395975
COVID-19 86.92 9.55 710 186299 244350 110157940
Blood alkaline phosphatase increased 86.04 9.55 290 186719 70645 110331645
Completed suicide 82.72 9.55 179 186830 242202 110160088
Chronic kidney disease 80.57 9.55 298 186711 75993 110326297
Acute respiratory failure 79.51 9.55 294 186715 74966 110327324
Gastrointestinal disorder 79.04 9.55 183 186826 241769 110160521
Night sweats 78.01 9.55 67 186942 133916 110268374
Respiratory failure 77.50 9.55 626 186383 214706 110187584
Viral test positive 77.09 9.55 35 186974 843 110401447
Live birth 75.91 9.55 13 186996 69471 110332819
Obesity 75.90 9.55 49 186960 113302 110288988
Upper respiratory tract inflammation 75.14 9.55 61 186948 4310 110397980
Osteoarthritis 74.54 9.55 121 186888 182502 110219788
Wound infection 74.30 9.55 35 186974 96430 110305860
Blood urea increased 73.23 9.55 232 186777 54725 110347565
Enterocolitis 73.17 9.55 122 186887 18827 110383463
Blood creatinine increased 69.27 9.55 538 186471 182351 110219939
Discomfort 68.84 9.55 164 186845 214543 110187747
Weight increased 68.52 9.55 422 186587 419222 109983068
Lung disorder 68.27 9.55 125 186884 179922 110222368
Lymphocyte stimulation test positive 67.97 9.55 34 186975 1022 110401268
Blepharospasm 67.69 9.55 7 187002 54844 110347446
Pulmonary fibrosis 67.12 9.55 45 186964 101997 110300293
Sepsis 66.20 9.55 845 186164 326501 110075789
Hypoxia 66.19 9.55 410 186599 129105 110273185
Diarrhoea 66.06 9.55 2450 184559 1137055 109265235
Pyrexia 65.98 9.55 1986 185023 896279 109506011
Bone erosion 65.64 9.55 3 187006 46368 110355922
Dermatitis atopic 65.52 9.55 138 186871 25403 110376887
Back pain 65.30 9.55 934 186075 370062 110032228
Mast cell activation syndrome 64.07 9.55 37 186972 1491 110400799
Urinary tract infection 63.77 9.55 837 186172 325445 110076845
Constipation 62.67 9.55 900 186109 356886 110045404
Plasma cell myeloma 60.83 9.55 239 186770 62697 110339593
Sciatica 60.43 9.55 41 186968 92358 110309932
Mucosal inflammation 60.02 9.55 321 186688 95820 110306470
Mouth haemorrhage 59.13 9.55 92 186917 13396 110388894
Prescribed overdose 58.44 9.55 38 186971 87543 110314747
Blood bilirubin increased 58.32 9.55 269 186740 75703 110326587
Alpha tumour necrosis factor increased 58.13 9.55 23 186986 389 110401901
Throat tightness 57.72 9.55 155 186854 33334 110368956
Nausea 57.41 9.55 2595 184414 1233095 109169195
Renal impairment 57.40 9.55 528 186481 187917 110214373
Hypercholesterolaemia 57.18 9.55 42 186967 90795 110311495
Monocyte chemotactic protein-1 increased 57.06 9.55 22 186987 346 110401944
Gait inability 56.93 9.55 89 186920 136287 110266003
Dry mouth 56.27 9.55 163 186846 199785 110202505
Throat irritation 55.56 9.55 208 186801 53344 110348946
Sleep disorder 55.13 9.55 163 186846 198481 110203809
Cholecystitis chronic 55.10 9.55 74 186935 9426 110392864
Pregnancy 54.81 9.55 10 186999 51057 110351233
Pneumonia 54.39 9.55 1900 185109 874814 109527476
White blood cell count increased 52.93 9.55 312 186697 96530 110305760
Overdose 51.95 9.55 211 186798 233583 110168707
Haemoglobin decreased 51.94 9.55 646 186363 248081 110154209
Wheezing 51.44 9.55 239 186770 254991 110147299
Condition aggravated 51.32 9.55 904 186105 733932 109668358
Red blood cell sedimentation rate increased 50.87 9.55 35 186974 78267 110324023
Frequent bowel movements 50.39 9.55 29 186980 71361 110330929
Chills 50.21 9.55 518 186491 190062 110212228
Decreased appetite 50.07 9.55 1104 185905 474742 109927548
Exposure during pregnancy 49.70 9.55 133 186876 167291 110234999
Peripheral swelling 49.32 9.55 441 186568 403593 109998697
Haematocrit decreased 49.20 9.55 232 186777 65885 110336405
Onychomadesis 48.89 9.55 9 187000 45654 110356636
Intentional product misuse 48.85 9.55 94 186915 132810 110269480
Suicide attempt 47.57 9.55 63 186946 103331 110298959
Drug resistance 47.34 9.55 18 186991 56356 110345934
Lower limb fracture 47.21 9.55 35 186974 75313 110326977
Pneumonia haemophilus 46.91 9.55 38 186971 2677 110399613
Cholecystitis acute 46.10 9.55 90 186919 15692 110386598
Hip arthroplasty 44.94 9.55 19 186990 55794 110346496
Blood creatine phosphokinase MB increased 44.68 9.55 38 186971 2865 110399425
Mechanical ventilation complication 44.32 9.55 23 186986 748 110401542
Tongue biting 44.27 9.55 38 186971 2901 110399389
Mental status changes 44.05 9.55 249 186760 75873 110326417
Arthritis 44.02 9.55 141 186868 167445 110234845
Blood albumin decreased 43.71 9.55 124 186885 27528 110374762
Pneumothorax 43.44 9.55 145 186864 35140 110367150
Coeliac disease 43.16 9.55 10 186999 43177 110359113
Red blood cell count decreased 43.13 9.55 223 186786 65700 110336590
Autoimmune disorder 42.90 9.55 29 186980 65454 110336836
Off label use 42.83 9.55 2088 184921 1498097 108904193
Pleural effusion 42.15 9.55 473 186536 177236 110225054
Exostosis 41.48 9.55 13 186996 45943 110356347
Road traffic accident 41.21 9.55 74 186935 107324 110294966
Confusional state 40.68 9.55 553 186456 468127 109934163
Illness 40.65 9.55 258 186751 81913 110320377
Epilepsy 40.32 9.55 67 186942 100142 110302148
Nail disorder 40.23 9.55 24 186985 57911 110344379
Abdominal discomfort 40.11 9.55 449 186560 393409 110008881
Blood pressure decreased 39.99 9.55 332 186677 114759 110287531
Hospice care 39.98 9.55 74 186935 12399 110389891
Product dose omission issue 39.88 9.55 765 186244 321017 110081273
Triple negative breast cancer 39.86 9.55 19 186990 513 110401777
Arthralgia 39.79 9.55 1009 186000 778623 109623667
Loss of personal independence in daily activities 39.55 9.55 126 186883 149894 110252396
Pharyngeal swelling 39.34 9.55 72 186937 11960 110390330
Myelosuppression 38.96 9.55 62 186947 94278 110308012
Contusion 38.93 9.55 233 186776 233128 110169162
Anaemia 38.82 9.55 1205 185804 545881 109856409
Onychomycosis 38.35 9.55 9 187000 38522 110363768
Medication error 38.31 9.55 75 186934 105291 110296999
Emotional distress 37.58 9.55 163 186846 44684 110357606
Interleukin level increased 37.50 9.55 27 186982 1594 110400696
Erythema multiforme 36.72 9.55 98 186911 20999 110381291
Finger deformity 36.57 9.55 6 187003 33086 110369204
Gastritis 36.07 9.55 183 186826 53516 110348774
Cerebral haemorrhage 35.94 9.55 210 186799 64758 110337532
Pneumonia aspiration 35.91 9.55 248 186761 80985 110321305
Coma 35.46 9.55 93 186916 117776 110284514
Lymphocyte count decreased 34.96 9.55 190 186819 57053 110345237
Knee arthroplasty 34.82 9.55 35 186974 64913 110337377
Hyperuricaemia 34.39 9.55 76 186933 14455 110387835
Therapy non-responder 34.29 9.55 143 186866 157164 110245126
Post cholecystectomy syndrome 34.05 9.55 20 186989 832 110401458
Hepatocellular injury 33.75 9.55 22 186987 50620 110351670
Sinusitis 33.54 9.55 330 186679 296358 110105932
Liver disorder 33.45 9.55 378 186631 141865 110260425
Dysphagia 33.38 9.55 402 186607 153198 110249092
Drug eruption 33.37 9.55 179 186830 53480 110348810
Intentional self-injury 33.05 9.55 11 186998 37418 110364872
Hypoalbuminaemia 32.98 9.55 116 186893 28858 110373432
Lupus-like syndrome 32.66 9.55 14 186995 40778 110361512
Foot deformity 32.39 9.55 21 186988 48459 110353831
Administration site inflammation 32.23 9.55 10 186999 78 110402212
Infection 31.91 9.55 426 186583 361774 110040516
Hypokalaemia 31.53 9.55 458 186551 181990 110220300
Blood immunoglobulin A increased 31.52 9.55 24 186985 1544 110400746
Pneumonia bacterial 31.52 9.55 107 186902 26154 110376136
Intentional dose omission 30.72 9.55 89 186920 19991 110382299
Ventricular tachycardia 30.54 9.55 166 186843 49843 110352447
Blood magnesium decreased 29.04 9.55 87 186922 19909 110382381
Ileus 28.33 9.55 115 186894 30614 110371676
Torsade de pointes 27.93 9.55 93 186916 22507 110379783
Vitamin B12 increased 27.81 9.55 25 186984 2030 110400260
Hypomagnesaemia 27.69 9.55 186 186823 60184 110342106
Blood potassium decreased 27.44 9.55 171 186838 53943 110348347
Impaired quality of life 27.41 9.55 112 186897 29905 110372385
Pneumonitis 27.24 9.55 222 186787 76309 110325981
Serum amyloid A protein increased 27.24 9.55 18 186991 924 110401366
Joint stiffness 27.01 9.55 45 186964 67198 110335092
Renal injury 26.78 9.55 81 186928 18632 110383658
Aspartate aminotransferase 26.78 9.55 18 186991 951 110401339
Unresponsive to stimuli 26.59 9.55 192 186817 63598 110338692
Haemorrhage subcutaneous 26.00 9.55 39 186970 5500 110396790
Nasopharyngitis 25.94 9.55 490 186519 393871 110008419
Psoriasis 25.94 9.55 135 186874 139858 110262432
Burkholderia test positive 25.87 9.55 15 186994 609 110401681
Gamma-glutamyltransferase increased 25.83 9.55 185 186824 61124 110341166
Tongue injury 25.69 9.55 15 186994 617 110401673
Post procedural complication 25.56 9.55 101 186908 26557 110375733
Salmonella bacteraemia 25.56 9.55 15 186994 623 110401667
Parenteral nutrition 25.55 9.55 17 186992 883 110401407
Joint dislocation 25.42 9.55 13 186996 34177 110368113
Vaccination site reaction 25.40 9.55 11 186998 236 110402054
Osteoporosis 25.28 9.55 70 186939 87082 110315208
Malignant neoplasm progression 25.13 9.55 425 186584 174142 110228148
Maternal exposure timing unspecified 25.12 9.55 3 187006 21010 110381280
Injury 25.03 9.55 186 186823 177079 110225211
Dyspnoea 24.97 9.55 2184 184825 1104688 109297602
Hepatotoxicity 24.94 9.55 43 186966 63357 110338933
Back injury 24.89 9.55 26 186983 47373 110354917
Foetal heart rate abnormal 24.78 9.55 15 186994 660 110401630
Product use in unapproved indication 24.69 9.55 572 186437 446805 109955485
Blood pressure ambulatory increased 24.58 9.55 8 187001 74 110402216
Drug tolerance decreased 24.48 9.55 8 187001 27532 110374758
Paraesthesia 24.42 9.55 325 186684 276196 110126094
Hypervolaemia 24.28 9.55 155 186854 49305 110352985
Eosinophilic oesophagitis 24.02 9.55 19 186990 1293 110400997
Blood pressure systolic increased 23.82 9.55 67 186942 82924 110319366
Protein total decreased 23.60 9.55 55 186954 10835 110391455
Therapy partial responder 23.50 9.55 17 186992 37044 110365246
Orthostatic hypertension 23.40 9.55 17 186992 1018 110401272
Cholestasis 23.39 9.55 46 186963 64472 110337818
Small intestinal obstruction 23.21 9.55 112 186897 32101 110370189
Glomerular filtration rate increased 23.10 9.55 22 186987 1923 110400367
Stevens-Johnson syndrome 23.03 9.55 147 186862 46754 110355536
Pain 23.02 9.55 1351 185658 953604 109448686
Adverse drug reaction 22.98 9.55 96 186913 105463 110296827
Death 22.88 9.55 1421 185588 697448 109704842
Haemodialysis 22.87 9.55 74 186935 17645 110384645
Platelet transfusion 22.67 9.55 26 186983 2820 110399470
Sinus tachycardia 22.19 9.55 140 186869 44353 110357937
Weight fluctuation 22.13 9.55 85 186924 22060 110380230
Anaphylactic shock 21.98 9.55 156 186853 51390 110350900
Blood creatine phosphokinase increased 21.85 9.55 204 186805 72873 110329417
Adverse event 21.84 9.55 102 186907 108707 110293583
Cough 21.84 9.55 972 186037 460669 109941621
Renal disorder 21.83 9.55 151 186858 49328 110352962
Rhinovirus infection 21.78 9.55 56 186953 11733 110390557
Porphyria acute 21.68 9.55 3 187006 18777 110383513
Hepatitis 21.45 9.55 79 186930 89975 110312315
Monocyte count increased 21.39 9.55 60 186949 13233 110389057
Impaired work ability 21.26 9.55 9 187000 26410 110375880
Nasal congestion 21.25 9.55 257 186752 98025 110304265
Drug interaction 21.21 9.55 664 186345 499519 109902771
Flatulence 21.18 9.55 156 186853 51993 110350297
Ulcer haemorrhage 21.07 9.55 6 187003 22565 110379725
Cardiac autonomic neuropathy 20.93 9.55 7 187002 71 110402219
Lip swelling 20.83 9.55 152 186857 50515 110351775
Concomitant disease aggravated 20.81 9.55 68 186941 16296 110385994
Biliary dyskinesia 20.79 9.55 23 186986 2398 110399892
Gastric perforation 20.75 9.55 33 186976 4896 110397394
Milk-alkali syndrome 20.69 9.55 21 186988 1984 110400306
Drug use disorder 20.60 9.55 3 187006 18071 110384219
Product dose omission in error 20.11 9.55 86 186923 23426 110378864
Hypophagia 20.01 9.55 155 186854 52471 110349819
Pleural neoplasm 20.00 9.55 11 186998 403 110401887
Disease progression 19.86 9.55 547 186462 243487 110158803
Product preparation issue 19.84 9.55 24 186985 2755 110399535
Heparin-induced thrombocytopenia 19.81 9.55 53 186956 11371 110390919
Psychotic disorder 19.62 9.55 35 186974 50902 110351388
Throat clearing 19.62 9.55 30 186979 4303 110397987
Pain in extremity 19.61 9.55 651 186358 486467 109915823
Inspiratory capacity decreased 19.49 9.55 23 186986 2572 110399718
Altered state of consciousness 19.35 9.55 165 186844 57461 110344829
Ammonia decreased 19.31 9.55 6 187003 47 110402243
Therapy cessation 19.27 9.55 136 186873 44721 110357569
Product administration interrupted 19.19 9.55 52 186957 11240 110391050
Post procedural haematoma 19.18 9.55 23 186986 2616 110399674
Dermatitis acneiform 19.16 9.55 56 186953 12639 110389651
Hepatic cirrhosis 19.11 9.55 55 186954 67571 110334719
Inappropriate antidiuretic hormone secretion 19.10 9.55 110 186899 33741 110368549
Colitis ulcerative 19 9.55 67 186942 77296 110324994
Exposure via skin contact 18.90 9.55 57 186952 13090 110389200
Erythema 18.83 9.55 635 186374 290812 110111478
Hypersensitivity myocarditis 18.78 9.55 10 186999 343 110401947
Polyneuropathy 18.64 9.55 16 186993 31996 110370294
Electric shock 18.59 9.55 19 186990 1809 110400481
Post-traumatic stress disorder 18.52 9.55 37 186972 6559 110395731
Bacteriuria 18.49 9.55 17 186992 1421 110400869
Ventricular flutter 18.28 9.55 7 187002 108 110402182
Tachycardia 18.16 9.55 507 186502 226138 110176152
Gallbladder injury 18.09 9.55 16 186993 1272 110401018
Asteatosis 18.01 9.55 9 187000 270 110402020
Reflux gastritis 17.92 9.55 17 186992 1479 110400811
Cholangitis acute 17.87 9.55 19 186990 1894 110400396
Pharyngeal inflammation 17.77 9.55 18 186991 1696 110400594
Catheter site haemorrhage 17.75 9.55 34 186975 5846 110396444
Impaired gastric emptying 17.64 9.55 56 186953 13219 110389071
Idiopathic urticaria 17.59 9.55 9 187000 284 110402006
Hypovolaemia 17.57 9.55 78 186931 21596 110380694
Encephalopathy 17.54 9.55 212 186797 80843 110321447
Tremor 17.51 9.55 457 186552 201775 110200515
Blood pressure diastolic abnormal 17.49 9.55 11 186998 25804 110376486
Cholelithiasis 17.46 9.55 174 186835 63248 110339042
Tumour lysis syndrome 17.32 9.55 100 186909 30701 110371589
Granulocyte count increased 17.31 9.55 19 186990 1964 110400326
Eosinophil count increased 17.23 9.55 76 186933 20982 110381308
Memory impairment 17.19 9.55 232 186777 196712 110205578
Pulmonary oedema 17.11 9.55 252 186757 100407 110301883
Oropharyngeal discomfort 17.00 9.55 47 186962 10280 110392010
Dyslalia 16.97 9.55 16 186993 1381 110400909
Pulmonary hypertension 16.94 9.55 155 186854 55065 110347225
Haemothorax 16.90 9.55 37 186972 6994 110395296
Cytomegalovirus infection reactivation 16.88 9.55 5 187004 18328 110383962
Amylase increased 16.81 9.55 53 186956 12466 110389824
Toxic epidermal necrolysis 16.78 9.55 158 186851 56569 110345721
Deep vein thrombosis 16.78 9.55 331 186678 139556 110262734
COVID-19 pneumonia 16.77 9.55 114 186895 37029 110365261
Cellulitis 16.77 9.55 303 186706 125713 110276577
Atelectasis 16.77 9.55 113 186896 36599 110365691
Post procedural haemorrhage 16.71 9.55 61 186948 15451 110386839
Gallbladder disorder 16.53 9.55 75 186934 20954 110381336
Eye irritation 16.52 9.55 105 186904 33347 110368943
Peritonitis 16.51 9.55 103 186906 32504 110369786
Supine hypertension 16.50 9.55 10 186999 441 110401849
Urine output decreased 16.47 9.55 72 186937 19804 110382486
Neuropathy peripheral 16.37 9.55 408 186601 178869 110223421
Anaplastic astrocytoma 16.34 9.55 7 187002 146 110402144
Spinal compression fracture 16.30 9.55 68 186941 18324 110383966
Gastroenteritis 16.29 9.55 117 186892 38683 110363607
Malnutrition 16.29 9.55 90 186919 27189 110375101
Blood pressure systolic abnormal 16.28 9.55 11 186998 24839 110377451
Oxygen saturation decreased 16.08 9.55 363 186646 156619 110245671
Incorrect route of product administration 16.06 9.55 55 186954 64006 110338284
Seasonal allergy 16.00 9.55 71 186938 19651 110382639
Tenosynovitis 15.82 9.55 4 187005 16279 110386011
Carcinoembryonic antigen 15.70 9.55 6 187003 92 110402198
Haematotoxicity 15.70 9.55 8 187001 21074 110381216
Febrile bone marrow aplasia 15.66 9.55 5 187004 17460 110384830
Sedation complication 15.60 9.55 7 187002 19848 110382442
Laryngitis 15.58 9.55 30 186979 42381 110359909
Shock symptom 15.51 9.55 10 186999 492 110401798
Labelled drug-drug interaction medication error 15.47 9.55 16 186993 29286 110373004
Blood pressure systolic decreased 15.46 9.55 54 186955 13387 110388903
Refusal of treatment by patient 15.42 9.55 43 186966 9451 110392839
Pruritus 15.40 9.55 1162 185847 580398 109821892
Empyema 15.35 9.55 31 186978 5539 110396751
Normal newborn 15.30 9.55 9 187000 21887 110380403
Rheumatoid factor increased 15.28 9.55 20 186989 2485 110399805
Face oedema 15.28 9.55 103 186906 33366 110368924
Insurance issue 15.25 9.55 46 186963 10566 110391724
Carbohydrate antigen 15-3 15.24 9.55 6 187003 100 110402190
Shock 15.23 9.55 148 186861 53440 110348850
Vitamin D deficiency 15.21 9.55 67 186942 18485 110383805
Breast adenoma 15.20 9.55 5 187004 48 110402242
Product quality issue 15.20 9.55 73 186936 77226 110325064
Epistaxis 15.14 9.55 307 186702 130065 110272225
Oxygen therapy 15.06 9.55 26 186983 4127 110398163
Sputum culture positive 14.96 9.55 25 186984 3864 110398426
Rectal haemorrhage 14.95 9.55 130 186879 119703 110282587
Hypochloraemia 14.92 9.55 24 186985 3594 110398696
Cardiac arrest 14.89 9.55 437 186572 196316 110205974
Heart rate increased 14.86 9.55 333 186676 143501 110258789
Therapy interrupted 14.85 9.55 139 186870 49683 110352607
Drug dependence 14.64 9.55 40 186969 49980 110352310
Palmar-plantar erythrodysaesthesia syndrome 14.59 9.55 119 186890 40906 110361384
Infusion site erythema 14.59 9.55 49 186960 11910 110390380
Infusion related hypersensitivity reaction 14.48 9.55 12 186997 873 110401417
Anhedonia 14.43 9.55 58 186951 15370 110386920
Infusion site swelling 14.37 9.55 43 186966 9834 110392456
Iron deficiency anaemia 14.33 9.55 97 186912 31462 110370828
Gastrointestinal haemorrhage 14.32 9.55 374 186635 165144 110237146
Seizure 14.30 9.55 482 186527 220703 110181587
Acute respiratory distress syndrome 14.19 9.55 145 186864 53053 110349237
Immune effector cell-associated neurotoxicity syndrome 14.17 9.55 56 186953 14726 110387564
Flashback 14.14 9.55 9 187000 433 110401857
Bronchiectasis 14.13 9.55 25 186984 36468 110365822
Disease prodromal stage 14.05 9.55 5 187004 62 110402228
Respiratory distress 13.98 9.55 178 186831 68696 110333594
Vitamin B12 deficiency 13.90 9.55 43 186966 10012 110392278
Chronic spontaneous urticaria 13.88 9.55 17 186992 1976 110400314
Creatinine renal clearance decreased 13.84 9.55 10 186999 21805 110380485
Cholinergic syndrome 13.83 9.55 14 186995 1318 110400972
Gastric ulcer haemorrhage 13.80 9.55 43 186966 10051 110392239
Prescribed underdose 13.73 9.55 60 186949 65114 110337176
Colitis ischaemic 13.73 9.55 63 186946 17687 110384603
Enterovirus infection 13.72 9.55 20 186989 2750 110399540
Ischaemic stroke 13.63 9.55 31 186978 41232 110361058
Blood chloride decreased 13.56 9.55 40 186969 9075 110393215
Embolism 13.49 9.55 59 186950 16230 110386060
Pneumonia staphylococcal 13.46 9.55 31 186978 6060 110396230
Troponin I increased 13.45 9.55 29 186980 5423 110396867
Pathergy reaction 13.37 9.55 5 187004 72 110402218
Seronegative arthritis 13.27 9.55 3 187006 13174 110389116
Nephrogenic anaemia 13.25 9.55 26 186983 4551 110397739
Blood potassium increased 13.24 9.55 99 186910 33150 110369140
Tracheal haemorrhage 13.24 9.55 11 186998 803 110401487
Angina unstable 13.22 9.55 59 186950 16373 110385917
Human chorionic gonadotropin decreased 13.19 9.55 5 187004 75 110402215
Autoimmune myocarditis 13.17 9.55 10 186999 641 110401649
Carotid artery stenosis 13.17 9.55 40 186969 9223 110393067
Underdose 13.10 9.55 59 186950 63495 110338795
Post transplant lymphoproliferative disorder 13.08 9.55 5 187004 15608 110386682
Ankylosing spondylitis 13.08 9.55 5 187004 15607 110386683
Bone pain 13.08 9.55 168 186841 64965 110337325
Stridor 12.99 9.55 33 186976 6862 110395428
Pelvic abscess 12.95 9.55 19 186990 2627 110399663
Vomiting 12.94 9.55 1743 185266 908932 109493358
Lymphocyte percentage increased 12.87 9.55 11 186998 835 110401455
Oedema 12.85 9.55 264 186745 209712 110192578
Blood pressure fluctuation 12.84 9.55 74 186935 74750 110327540
Personality disorder 12.77 9.55 3 187006 12834 110389456
Blood pressure abnormal 12.74 9.55 73 186936 22351 110379939
Device related infection 12.67 9.55 112 186897 39407 110362883
Basal cell carcinoma 12.66 9.55 37 186972 45233 110357057
Cholecystitis 12.63 9.55 81 186928 25801 110376489
Stomatitis 12.62 9.55 354 186655 269888 110132402
Transfusion 12.61 9.55 80 186929 25392 110376898
Schizophrenia 12.59 9.55 11 186998 21815 110380475
Tendon injury 12.59 9.55 18 186991 2431 110399859
Cardiogenic shock 12.57 9.55 52 186957 57286 110345004
Pharyngitis 12.53 9.55 79 186930 25019 110377271
Bacteraemia 12.50 9.55 118 186891 42272 110360018
Early satiety 12.48 9.55 16 186993 1947 110400343
Haemolytic anaemia 12.48 9.55 69 186940 20851 110381439
Chronic gastritis 12.47 9.55 28 186981 5383 110396907
Full blood count decreased 12.46 9.55 95 186914 32004 110370286
Thrombocytopenia 12.44 9.55 715 186294 348170 110054120
Putamen haemorrhage 12.43 9.55 9 187000 536 110401754
Musculoskeletal disorder 12.39 9.55 12 186997 22652 110379638
Surfactant protein increased 12.39 9.55 4 187005 36 110402254
Bulbospinal muscular atrophy congenital 12.39 9.55 4 187005 36 110402254
Haptoglobin decreased 12.37 9.55 15 186994 1726 110400564
Cancer pain 12.34 9.55 32 186977 6740 110395550
Dry skin 12.33 9.55 253 186756 107400 110294890
Paronychia 12.30 9.55 44 186965 11037 110391253
SARS-CoV-2 test positive 12.29 9.55 59 186950 16876 110385414
Prohormone brain natriuretic peptide increased 12.24 9.55 8 187001 403 110401887
Bronchitis 12.22 9.55 350 186659 156682 110245608
Haemorrhagic diathesis 12.19 9.55 34 186975 7474 110394816
Hyperglycaemia 12.18 9.55 207 186802 84883 110317407
Hypernatraemia 12.13 9.55 61 186948 17772 110384518
Hypertensive crisis 12.10 9.55 14 186995 24358 110377932
Foetal death 12.08 9.55 6 187003 16039 110386251
Neurosurgery 12.06 9.55 5 187004 96 110402194
Acidosis 11.93 9.55 72 186937 22459 110379831
C-reactive protein increased 11.90 9.55 279 186730 217640 110184650
Muscle spasticity 11.85 9.55 27 186982 35888 110366402
Neutrophil percentage decreased 11.84 9.55 11 186998 932 110401358
Head injury 11.83 9.55 118 186891 42899 110359391
Walking aid user 11.82 9.55 15 186994 25060 110377230
Angiopathy 11.76 9.55 37 186972 8693 110393597
Pityriasis lichenoides et varioliformis acuta 11.75 9.55 4 187005 43 110402247
Blindness transient 11.74 9.55 29 186980 5927 110396363
Embolic stroke 11.73 9.55 37 186972 8706 110393584
Fibrin D dimer increased 11.71 9.55 40 186969 9805 110392485
Gastroenteritis salmonella 11.70 9.55 13 186996 1362 110400928
Acute myocardial infarction 11.70 9.55 203 186806 83574 110318716
Hypersensitivity 11.68 9.55 561 186448 403437 109998853
Hypotension 11.66 9.55 1033 185976 522816 109879474
Lung adenocarcinoma 11.58 9.55 39 186970 9492 110392798
Intensive care 11.52 9.55 17 186992 2362 110399928
Heart transplant 11.52 9.55 14 186995 1614 110400676
Spondylolisthesis 11.51 9.55 22 186987 3776 110398514
Infusion site pain 11.44 9.55 59 186950 17360 110384930
Postural orthostatic tachycardia syndrome 11.44 9.55 15 186994 1867 110400423
Drug clearance decreased 11.43 9.55 23 186986 4099 110398191
Thrombotic cerebral infarction 11.42 9.55 10 186999 784 110401506
Forced expiratory volume decreased 11.41 9.55 4 187005 13172 110389118
Urge incontinence 11.40 9.55 13 186996 1402 110400888
Accidental overdose 11.37 9.55 47 186962 51787 110350503
Hereditary angioedema 11.34 9.55 32 186977 7082 110395208
Gastric ulcer 11.32 9.55 110 186899 39717 110362573
Obstructive airways disorder 11.31 9.55 40 186969 46109 110356181
Essential hypertension 11.26 9.55 34 186975 7813 110394477
Female genital tract fistula 11.25 9.55 7 187002 16512 110385778
Ehlers-Danlos syndrome 11.24 9.55 7 187002 324 110401966
Dry eye 11.24 9.55 144 186865 55649 110346641
Seborrhoeic dermatitis 11.22 9.55 18 186991 2689 110399601
Device expulsion 11.22 9.55 22 186987 30869 110371421
Nodule 11.20 9.55 24 186985 32607 110369683
Mean arterial pressure increased 11.19 9.55 5 187004 116 110402174
Hyperamylasaemia 11.18 9.55 12 186997 1209 110401081
Anaphylactoid reaction 11.17 9.55 31 186978 6795 110395495
Kidney transplant rejection 11.16 9.55 45 186964 11942 110390348
Reticulocyte percentage increased 11.14 9.55 4 187005 51 110402239
Ventricular extrasystoles 11.14 9.55 71 186938 22570 110379720
Renal failure 11.13 9.55 479 186530 226095 110176195
Cardiac disorder 11.08 9.55 186 186823 76094 110326196
Viral infection 11.07 9.55 138 186871 53001 110349289
Non-small cell lung cancer 11.03 9.55 34 186975 7901 110394389
Colon cancer 11.01 9.55 56 186953 16387 110385903
Aspartate aminotransferase abnormal 11.00 9.55 20 186989 3305 110398985
Extensor plantar response 10.99 9.55 15 186994 1940 110400350
Extrapyramidal disorder 10.97 9.55 20 186989 28847 110373443
Chest pain 10.97 9.55 758 186251 375617 110026673
Oropharyngeal pain 10.94 9.55 303 186706 134973 110267317
Non-cardiac chest pain 10.90 9.55 40 186969 10158 110392132
Tubulointerstitial nephritis 10.89 9.55 140 186869 54144 110348146
Urine osmolarity decreased 10.84 9.55 5 187004 125 110402165
Eye discharge 10.80 9.55 36 186973 8718 110393572
Post procedural fever 10.80 9.55 9 187000 660 110401630
Decubitus ulcer 10.78 9.55 60 186949 18176 110384114
Lethargy 10.74 9.55 220 186789 93356 110308934
Feeling abnormal 10.73 9.55 390 186619 180321 110221969
Respiratory depression 10.60 9.55 24 186985 31977 110370313
Catatonia 10.56 9.55 3 187006 11297 110390993
Electrocardiogram T wave biphasic 10.54 9.55 6 187003 235 110402055
Antithrombin III decreased 10.54 9.55 8 187001 512 110401778
Hypergeusia 10.49 9.55 3 187006 17 110402273
Heliotrope rash 10.48 9.55 6 187003 238 110402052
Product contamination microbial 10.46 9.55 11 186998 1083 110401207
Hypopituitarism 10.43 9.55 23 186986 4367 110397923
Cholecystectomy 10.40 9.55 41 186968 10768 110391522
Carbon dioxide decreased 10.39 9.55 24 186985 4700 110397590
Eustachian tube dysfunction 10.37 9.55 9 187000 697 110401593
Gallbladder enlargement 10.37 9.55 15 186994 2047 110400243
Brain natriuretic peptide increased 10.37 9.55 42 186967 11167 110391123
Gastrointestinal toxicity 10.34 9.55 3 187006 11145 110391145
Surgery 10.29 9.55 111 186898 41172 110361118
Biliary tract disorder 10.25 9.55 14 186995 1812 110400478
Pseudomonas test positive 10.24 9.55 16 186993 2338 110399952
Proctitis bacterial 10.22 9.55 5 187004 143 110402147
Blood glucose increased 10.22 9.55 295 186714 132201 110270089
Pulse absent 10.20 9.55 42 186967 11250 110391040
Sputum retention 10.13 9.55 12 186997 1347 110400943
Joint noise 10.10 9.55 25 186984 5118 110397172
Restless arm syndrome 10.09 9.55 4 187005 68 110402222
Staphylococcal sepsis 10.03 9.55 57 186952 17397 110384893
Glucose tolerance impaired 10.03 9.55 38 186971 9799 110392491
Sensation of foreign body 10.02 9.55 33 186976 7942 110394348
Taste disorder 10.01 9.55 67 186942 65320 110336970
Blood sodium decreased 10.01 9.55 104 186905 38215 110364075
Picornavirus infection 10.00 9.55 5 187004 150 110402140
White blood cell count abnormal 9.98 9.55 30 186979 6879 110395411
SJS-TEN overlap 9.97 9.55 14 186995 1860 110400430
Vulvovaginal candidiasis 9.92 9.55 19 186990 3266 110399024
Multiple-drug resistance 9.89 9.55 5 187004 13230 110389060
Metabolic encephalopathy 9.89 9.55 41 186968 11019 110391271
Chronic sinusitis 9.88 9.55 17 186992 25067 110377223
Syndactyly 9.85 9.55 5 187004 155 110402135
Myalgia 9.80 9.55 465 186544 221916 110180374
Malignant ascites 9.78 9.55 12 186997 1398 110400892
Blood bilirubin unconjugated increased 9.77 9.55 11 186998 1170 110401120
Coronary artery disease 9.76 9.55 173 186836 71517 110330773
Haemorrhage intracranial 9.76 9.55 83 186926 28886 110373404
Upper respiratory tract infection 9.75 9.55 291 186718 131037 110271253
Intercepted product storage error 9.74 9.55 9 187000 757 110401533
Mechanical urticaria 9.74 9.55 8 187001 575 110401715
Urticaria chronic 9.72 9.55 9 187000 759 110401531
Oesophageal candidiasis 9.72 9.55 42 186967 11492 110390798
Prothrombin time prolonged 9.68 9.55 56 186953 17205 110385085
Gastrooesophageal reflux disease 9.64 9.55 384 186625 179592 110222698
Urticaria 9.61 9.55 644 186365 318213 110084077
Lymphatic disorder 9.57 9.55 7 187002 424 110401866

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
MeSH PA D000897 Anti-Ulcer Agents
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006635 Histamine H2 Antagonists
MeSH PA D018377 Neurotransmitter Agents
CHEBI has role CHEBI:37961 H<small><sub>2</sub></small>-receptor antagonist
CHEBI has role CHEBI:49201 anti-ulcer drug
CHEBI has role CHEBI:50183 P450 inhibitor
FDA EPC N0000175784 Histamine-2 Receptor Antagonist

Related Drugs by ATC class:

A02BA H2-receptor antagonists 6 drugs
cimetidinelafutidineniperotidinenizatidineranitidineroxatidine acetate

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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** DUEXIS HORIZON N022519 April 23, 2011 DISCN 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** DUEXIS HORIZON N022519 April 23, 2011 DISCN 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
5QZO15J2Z8 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 0113-0141 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
injoy heartburn relief HUMAN OTC DRUG LABEL 3 0113-6023 TABLET, CHEWABLE 10 mg ORAL ANDA 15 sections
GOOD SENSE DUAL ACTION COMPLETE HUMAN OTC DRUG LABEL 3 0113-7050 TABLET, CHEWABLE 10 mg ORAL ANDA 15 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0172-5728 TABLET, FILM COATED 20 mg ORAL ANDA 25 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0172-5729 TABLET, FILM COATED 40 mg ORAL ANDA 25 sections
Pepcid HUMAN PRESCRIPTION DRUG LABEL 1 0187-4420 TABLET, FILM COATED 20 mg ORAL ANDA 25 sections
Pepcid HUMAN PRESCRIPTION DRUG LABEL 1 0187-4440 TABLET, FILM COATED 40 mg ORAL ANDA 25 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0338-5197 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 22 sections
Acid ControllerOriginal Strength HUMAN OTC DRUG LABEL 1 0363-0141 TABLET, FILM COATED 10 mg ORAL ANDA 15 sections
Acid Reducer Complete HUMAN OTC DRUG LABEL 3 0363-0511 TABLET, CHEWABLE 10 mg ORAL ANDA 15 sections
Acid Controller HUMAN OTC DRUG LABEL 1 0363-0701 TABLET, FILM COATED 20 mg ORAL ANDA 15 sections
Acid Reducer Complete HUMAN OTC DRUG LABEL 3 0363-0713 TABLET, CHEWABLE 10 mg ORAL ANDA 15 sections
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
ACID REDUCER COMPLETE HUMAN OTC DRUG LABEL 3 0363-4036 TABLET, CHEWABLE 10 mg ORAL ANDA 15 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
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