naproxen ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
1883 22204-53-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • methoxypropiocin
  • naproxen
  • naprosyn
  • aproxen
  • naproxen sodium
  • aleve
An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.
  • Molecular weight: 230.26
  • Formula: C14H14O3
  • CLOGP: 2.82
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 1
  • TPSA: 46.53
  • ALOGS: -3.65
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.50 g O
0.50 g R
0.50 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.12 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 108.57 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.09 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.07 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.00 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 16.63 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
March 11, 1976 FDA ROCHE PALO

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
Pharyngitis 385.50 9.66 383 174039 17120 50413582
C-reactive protein abnormal 342.12 9.66 450 173972 27359 50403343
Red blood cell sedimentation rate abnormal 336.82 9.66 345 174077 15998 50414704
Death 283.56 9.66 427 173995 324952 50105750
Rheumatoid arthritis 266.04 9.66 1389 173033 201161 50229541
Drug hypersensitivity 249.85 9.66 1599 172823 249411 50181291
Deafness transitory 241.97 9.66 120 174302 1676 50429026
Gastrointestinal pain 236.70 9.66 207 174215 7849 50422853
Ankylosing spondylitis 218.38 9.66 188 174234 6977 50423725
Drug ineffective 191.01 9.66 3914 170508 815419 49615283
Musculoskeletal stiffness 181.71 9.66 900 173522 127581 50303121
Arthralgia 171.82 9.66 2284 172138 436418 49994284
Synovitis 156.60 9.66 841 173581 123024 50307678
Shoulder arthroplasty 155.67 9.66 114 174308 3334 50427368
Impaired work ability 145.44 9.66 206 174216 13434 50417268
Pain in extremity 145.40 9.66 1508 172914 271357 50159345
Psoriatic arthropathy 145.01 9.66 423 173999 46609 50384093
Rheumatoid nodule 144.25 9.66 198 174224 12537 50418165
Maternal exposure during pregnancy 138.58 9.66 210 174212 159568 50271134
Pemphigus 137.29 9.66 127 174295 120039 50310663
Toothache 133.41 9.66 222 174200 16672 50414030
Body height below normal 132.41 9.66 83 174339 1866 50428836
Psoriasis 131.98 9.66 529 173893 68471 50362231
Arthritis 125.75 9.66 612 173810 86109 50344593
Human antichimeric antibody positive 120.67 9.66 71 174351 1418 50429284
Pyrexia 120.41 9.66 792 173630 379411 50051291
Hypoaesthesia 120.38 9.66 801 173621 126456 50304246
Pain 119.58 9.66 2720 171702 576183 49854519
Neutropenia 119.34 9.66 204 174218 147761 50282941
Ear infection 118.81 9.66 271 174151 25699 50405003
C-reactive protein increased 115.63 9.66 495 173927 65979 50364723
Gastric ulcer 113.03 9.66 236 174186 21069 50409633
Foot operation 112.93 9.66 116 174306 5394 50425308
Febrile neutropenia 111.81 9.66 103 174319 97564 50333138
Cholecystitis chronic 110.52 9.66 151 174271 9518 50421184
Fibromyalgia 109.65 9.66 373 174049 44605 50386097
Nerve injury 108.71 9.66 139 174283 8211 50422491
Musculoskeletal disorder 107.43 9.66 205 174217 17144 50413558
Osteoporosis 105.76 9.66 368 174054 44511 50386191
Polyarthritis 103.27 9.66 132 174290 7795 50422907
Joint laxity 103.12 9.66 77 174345 2321 50428381
Nephrolithiasis 103.09 9.66 308 174114 34385 50396317
Femur fracture 102.38 9.66 323 174099 37141 50393561
Exposure during pregnancy 101.14 9.66 163 174259 120852 50309850
Hyponatraemia 100.20 9.66 110 174312 96029 50334673
Arthropathy 99.84 9.66 905 173517 157001 50273701
Confusional state 99.61 9.66 319 174103 185609 50245093
Joint swelling 99.40 9.66 1286 173136 244000 50186702
Pancytopenia 99.32 9.66 86 174336 83944 50346758
Multiple fractures 98.87 9.66 118 174304 6493 50424209
Systemic lupus erythematosus 97.59 9.66 212 174210 140410 50290292
Anaemia 97.46 9.66 493 173929 251963 50178739
Cardiac failure 95.88 9.66 73 174349 75967 50354735
Loose body in joint 91.33 9.66 55 174367 1148 50429554
Pneumonia 90.92 9.66 850 173572 377551 50053151
Injury 90.28 9.66 371 174051 48554 50382148
Leukopenia 90.15 9.66 61 174361 67467 50363235
Dislocation of vertebra 90.03 9.66 79 174343 3008 50427694
Glossodynia 89.85 9.66 163 174259 115406 50315296
Gait inability 89.31 9.66 306 174116 36721 50393981
Obesity 89.19 9.66 186 174236 16589 50414113
Red blood cell sedimentation rate increased 86.31 9.66 260 174162 29156 50401546
Seronegative arthritis 83.80 9.66 64 174358 1997 50428705
Dyspnoea 78.93 9.66 1371 173051 546237 49884465
Thrombocytopenia 78.62 9.66 205 174217 127468 50303234
Sepsis 78.41 9.66 218 174204 132707 50297995
Malignant neoplasm progression 77.77 9.66 72 174350 68052 50362650
Disease progression 76.50 9.66 133 174289 95733 50334969
Abdominal pain upper 75.67 9.66 861 173561 158448 50272254
Musculoskeletal pain 73.51 9.66 463 173959 71714 50358988
Functional gastrointestinal disorder 73.34 9.66 74 174348 3368 50427334
Migraine 71.82 9.66 475 173947 74805 50355897
Joint destruction 70.59 9.66 77 174345 3839 50426863
Systemic lupus erythematosus rash 70.27 9.66 54 174368 1701 50429001
Cardiac failure congestive 70.16 9.66 114 174308 84268 50346434
Drug tolerance 68.22 9.66 85 174337 4891 50425811
Sleep disorder due to general medical condition, insomnia type 67.85 9.66 13 174409 31434 50399268
Wound 65.79 9.66 169 174253 105625 50325077
Pericarditis 65.71 9.66 106 174316 78583 50352119
Drug tolerance decreased 63.96 9.66 114 174308 9046 50421656
Mycotic allergy 63.62 9.66 38 174384 781 50429921
Inflammation 63.60 9.66 374 174048 56538 50374164
Wheelchair user 63.52 9.66 82 174340 4890 50425812
Dizziness 63.43 9.66 1602 172820 344767 50085935
Mobility decreased 63.19 9.66 482 173940 79466 50351236
Ulcer 62.54 9.66 182 174240 20018 50410684
Bradycardia 62.51 9.66 78 174344 64348 50366354
Folliculitis 61.59 9.66 29 174393 39196 50391506
Pseudoporphyria 61.48 9.66 23 174399 151 50430551
Respiratory tract congestion 61.46 9.66 145 174277 14054 50416648
Enthesopathy 60.13 9.66 97 174325 7096 50423606
Neck pain 58.68 9.66 367 174055 56700 50374002
Drug interaction 58.49 9.66 425 173997 199196 50231506
Muscle injury 57.40 9.66 28 174394 37083 50393619
Tenosynovitis stenosans 57.15 9.66 53 174369 2171 50428531
Dehydration 55.23 9.66 304 174118 152145 50278557
Off label use 54.29 9.66 1234 173188 473192 49957510
Antibody test positive 53.53 9.66 52 174370 2259 50428443
Hospitalisation 52.62 9.66 96 174326 67841 50362861
Bunion operation 52.25 9.66 38 174384 1099 50429603
Arthrodesis 52.17 9.66 53 174369 2432 50428270
Synovial fluid analysis 52.00 9.66 44 174378 1594 50429108
Intestinal diaphragm disease 51.86 9.66 18 174404 92 50430610
Drug specific antibody 51.82 9.66 46 174376 1779 50428923
Hypotension 51.80 9.66 540 173882 234929 50195773
Adrenal insufficiency 50.68 9.66 135 174287 14108 50416594
Emotional distress 50.24 9.66 214 174208 28449 50402253
Osteoporotic fracture 50.12 9.66 58 174364 3087 50427615
Foot deformity 50.08 9.66 163 174259 19047 50411655
Foetal exposure during pregnancy 49.93 9.66 16 174406 27343 50403359
Drug intolerance 49.85 9.66 1045 173377 218059 50212643
Bone density decreased 48.91 9.66 114 174308 10961 50419741
Bone disorder 48.79 9.66 159 174263 18593 50412109
Renal impairment 47.70 9.66 120 174302 75541 50355161
White blood cell count decreased 46.65 9.66 225 174197 116497 50314205
Drug abuse 45.96 9.66 85 174337 59761 50370941
Platelet count decreased 45.17 9.66 186 174236 100540 50330162
Lip swelling 45.16 9.66 187 174235 24549 50406153
Synovial cyst 45.12 9.66 92 174330 8074 50422628
Hypomagnesaemia 45.09 9.66 12 174410 23144 50407558
Haematemesis 44.79 9.66 202 174220 27523 50403179
Pleuritic pain 44.54 9.66 80 174342 6386 50424316
Juvenile idiopathic arthritis 44.06 9.66 52 174370 2827 50427875
Multiple organ dysfunction syndrome 43.74 9.66 66 174356 50271 50380431
Feeding disorder 43.37 9.66 106 174316 10507 50420195
Gamma-glutamyltransferase increased 43.37 9.66 24 174398 29599 50401103
Wound infection 43.08 9.66 115 174307 12033 50418669
Scleritis 42.45 9.66 54 174368 3173 50427529
Neovascularisation 42.39 9.66 32 174390 981 50429721
Alopecia 42.06 9.66 593 173829 244454 50186248
Blood parathyroid hormone decreased 41.52 9.66 82 174340 7032 50423670
Weight decreased 41.21 9.66 1026 173396 220219 50210483
Gastric ulcer haemorrhage 40.99 9.66 63 174359 4421 50426281
Deafness 40.78 9.66 133 174289 15558 50415144
Pulmonary congestion 40.31 9.66 130 174292 15117 50415585
Tendonitis 40.23 9.66 138 174284 16567 50414135
Orthostatic hypotension 40.19 9.66 26 174396 29455 50401247
Fear of injection 40.13 9.66 74 174348 6029 50424673
Renal failure 40.07 9.66 210 174212 106423 50324279
Posterior reversible encephalopathy syndrome 39.93 9.66 3 174419 14925 50415777
Drug eruption 39.65 9.66 174 174248 23432 50407270
Choanal stenosis 39.40 9.66 11 174411 22 50430680
Neutrophil count decreased 39.37 9.66 61 174361 45965 50384737
Grip strength decreased 38.28 9.66 110 174312 12011 50418691
Respiratory failure 38.06 9.66 173 174249 91008 50339694
Cartilage atrophy 37.50 9.66 16 174406 154 50430548
Condition aggravated 37.44 9.66 1312 173110 295746 50134956
Limb discomfort 36.79 9.66 174 174248 24183 50406519
Tenosynovitis 36.44 9.66 99 174323 10466 50420236
Premature delivery 36.37 9.66 18 174404 23645 50407057
Therapy non-responder 36.13 9.66 300 174122 50722 50379980
Dactylitis 36.02 9.66 38 174384 1823 50428879
Pulmonary arterial hypertension 35.15 9.66 13 174409 20306 50410396
Wrist deformity 35.12 9.66 37 174385 1772 50428930
Granuloma skin 35.10 9.66 68 174354 5750 50424952
Hand deformity 35.08 9.66 202 174220 99997 50330705
Drug resistance 34.84 9.66 11 174411 18978 50411724
Nodule 34.62 9.66 133 174289 16870 50413832
Duodenal ulcer haemorrhage 34.61 9.66 40 174382 2126 50428576
Hypoglycaemia 34.53 9.66 84 174338 53497 50377205
Panniculitis 33.77 9.66 84 174338 8419 50422283
Red blood cell sedimentation rate 33.65 9.66 51 174371 3535 50427167
Soft tissue injury 33.64 9.66 33 174389 1451 50429251
Hunger 33.62 9.66 56 174366 4207 50426495
Smear cervix abnormal 33.14 9.66 44 174378 2697 50428005
Fracture delayed union 33.01 9.66 40 174382 2236 50428466
Disability 32.94 9.66 108 174314 12667 50418035
Abnormal loss of weight 32.79 9.66 61 174361 5003 50425699
Swelling face 32.44 9.66 300 174122 52295 50378407
Upper gastrointestinal haemorrhage 32.30 9.66 125 174297 15910 50414792
Sopor 32.29 9.66 14 174408 19865 50410837
Device expulsion 32.25 9.66 31 174391 28791 50401911
Paraesthesia 32.21 9.66 588 173834 119655 50311047
Irritable bowel syndrome 32.10 9.66 82 174340 51359 50379343
Serum sickness-like reaction 31.85 9.66 20 174402 451 50430251
Hypervolaemia 31.47 9.66 25 174397 25474 50405228
Peripheral swelling 30.95 9.66 929 173493 205007 50225695
Alanine aminotransferase abnormal 30.67 9.66 53 174369 4103 50426599
Respiratory distress 30.54 9.66 36 174386 30453 50400249
Hyperkalaemia 30.51 9.66 76 174346 48013 50382689
Tongue disorder 30.44 9.66 85 174337 9131 50421571
Pulmonary hypertension 29.83 9.66 43 174379 33374 50397328
Biliary dyskinesia 29.41 9.66 40 174382 2510 50428192
Limb deformity 29.38 9.66 49 174373 3685 50427017
Ascites 29.28 9.66 49 174373 35812 50394890
Myelodysplastic syndrome 29.16 9.66 8 174414 15124 50415578
International normalised ratio increased 29.13 9.66 66 174356 43086 50387616
Bursitis 29.08 9.66 152 174270 21983 50408719
Neuropathy peripheral 28.79 9.66 205 174217 96552 50334150
Osteonecrosis of jaw 27.92 9.66 43 174379 32483 50398219
Gallbladder injury 27.90 9.66 28 174394 1266 50429436
Right ventricular failure 27.78 9.66 10 174412 15883 50414819
Blepharospasm 27.77 9.66 42 174380 2906 50427796
Anti-cyclic citrullinated peptide antibody positive 27.65 9.66 137 174285 70450 50360252
Skin necrosis 27.25 9.66 91 174331 10776 50419926
Goitre 27.13 9.66 58 174364 5262 50425440
Hypoxia 27.13 9.66 88 174334 51035 50379667
Amnesia 27.05 9.66 243 174179 42017 50388685
Hepatic enzyme increased 27.02 9.66 323 174099 137057 50293645
Tachycardia 26.55 9.66 218 174204 99545 50331157
Neoplasm progression 26.54 9.66 37 174385 29120 50401582
Myelosuppression 26.33 9.66 7 174415 13510 50417192
Headache 26.16 9.66 2055 172367 504480 49926222
Oesophageal ulcer 26.14 9.66 48 174374 3897 50426805
Body temperature decreased 26.14 9.66 119 174303 16276 50414426
Gastrooesophageal reflux disease 26.11 9.66 389 174033 76039 50354663
Myofascial pain syndrome 26.06 9.66 34 174388 2049 50428653
Skin ulcer 25.72 9.66 209 174213 35109 50395593
Creatinine renal clearance decreased 25.44 9.66 5 174417 11876 50418826
Photophobia 25.20 9.66 110 174312 14777 50415925
Joint effusion 25.01 9.66 100 174322 12921 50417781
Electrolyte imbalance 25.00 9.66 14 174408 17155 50413547
Blood pressure systolic increased 24.86 9.66 208 174214 35241 50395461
Joint injury 24.86 9.66 144 174278 21645 50409057
Infection 24.85 9.66 776 173646 172178 50258524
Bone lesion 24.81 9.66 55 174367 5115 50425587
Dysstasia 24.55 9.66 124 174298 17695 50413007
Sacroiliitis 24.46 9.66 37 174385 2560 50428142
Tooth disorder 24.39 9.66 155 174267 24073 50406629
Hyperglycaemia 24.31 9.66 56 174366 36349 50394353
Encephalopathy 24.04 9.66 50 174372 33661 50397041
Premature baby 23.89 9.66 17 174405 18320 50412382
Aorta hypoplasia 23.51 9.66 11 174411 134 50430568
Spinal fusion surgery 23.26 9.66 46 174376 3949 50426753
Stomatitis 23.24 9.66 230 174192 101114 50329588
Chronic spontaneous urticaria 22.92 9.66 17 174405 507 50430195
Rash pruritic 22.85 9.66 259 174163 47587 50383115
Full blood count decreased 22.79 9.66 26 174396 22320 50408382
Device ineffective 22.67 9.66 11 174411 146 50430556
Sensitivity to weather change 22.49 9.66 58 174364 5943 50424759
Feeling jittery 22.48 9.66 87 174335 11073 50419629
Limb operation 22.38 9.66 41 174381 3323 50427379
Cardiogenic shock 22.31 9.66 13 174409 15586 50415116
Clear cell renal cell carcinoma 22.29 9.66 24 174398 1179 50429523
General physical health deterioration 22.22 9.66 351 174071 142083 50288619
Tooth infection 22.18 9.66 102 174320 14010 50416692
Cerebral haemorrhage 22.05 9.66 37 174385 27015 50403687
Palmar-plantar erythrodysaesthesia syndrome 22.05 9.66 22 174400 20076 50410626
Tenderness 22.04 9.66 124 174298 18441 50412261
Pregnancy 21.84 9.66 43 174379 29534 50401168
Hepatocellular injury 21.61 9.66 35 174387 25912 50404790
Flank pain 21.52 9.66 96 174326 13019 50417683
Neurotoxicity 21.49 9.66 12 174410 14728 50415974
Skin papilloma 21.45 9.66 46 174376 4183 50426519
Bone marrow failure 21.41 9.66 39 174383 27585 50403117
Colitis 21.37 9.66 65 174357 38464 50392238
Acute respiratory failure 21.11 9.66 42 174380 28740 50401962
Spondyloarthropathy 21.01 9.66 19 174403 753 50429949
Atelectasis 21.01 9.66 121 174301 18149 50412553
Therapeutic response decreased 20.93 9.66 252 174170 46979 50383723
Duodenal ulcer 20.93 9.66 61 174361 6714 50423988
Walking aid user 20.92 9.66 59 174363 6374 50424328
Joint range of motion decreased 20.89 9.66 122 174300 18390 50412312
Therapeutic product effect decreased 20.76 9.66 615 173807 135435 50295267
Cholelithiasis 20.67 9.66 211 174211 37762 50392940
Product use in unapproved indication 20.65 9.66 278 174144 115541 50315161
Blood creatine phosphokinase increased 20.64 9.66 37 174385 26330 50404372
Heart rate 20.59 9.66 8 174414 59 50430643
Hodgkin's disease 20.53 9.66 19 174403 776 50429926
Eye pain 20.53 9.66 168 174254 28281 50402421
Blood pressure measurement 20.51 9.66 12 174410 237 50430465
Renal mass 20.49 9.66 29 174393 1889 50428813
Hepatic function abnormal 20.46 9.66 52 174370 32629 50398073
Impaired healing 20.36 9.66 346 174076 69440 50361262
Sedation complication 20.29 9.66 3 174419 8763 50421939
Plasma cell myeloma 20.26 9.66 49 174373 31273 50399429
Pharyngeal swelling 20.16 9.66 47 174375 4519 50426183
Hypophagia 20.14 9.66 164 174258 27564 50403138
Paradoxical drug reaction 20.04 9.66 41 174381 3606 50427096
Adenoiditis 19.98 9.66 7 174415 37 50430665
Malaise 19.94 9.66 1377 173045 334155 50096547
Syncope 19.93 9.66 243 174179 102759 50327943
Endocarditis fibroplastica 19.92 9.66 5 174417 5 50430697
Hepatotoxicity 19.74 9.66 40 174382 27186 50403516
Caesarean section 19.72 9.66 15 174407 15624 50415078
Adjustment disorder with depressed mood 19.62 9.66 35 174387 2779 50427923
Acute myeloid leukaemia 19.60 9.66 14 174408 15060 50415642
Immunodeficiency 19.60 9.66 102 174320 14726 50415976
Psychotic disorder 19.53 9.66 28 174394 21784 50408918
Skin fissures 19.48 9.66 70 174352 8598 50422104
Neuroleptic malignant syndrome 19.46 9.66 7 174415 11123 50419579
Periorbital oedema 19.36 9.66 49 174373 4963 50425739
Helicobacter infection 19.16 9.66 97 174325 49605 50381097
Deep vein thrombosis 19.10 9.66 357 174065 72947 50357755
Hepatic adenoma 19.05 9.66 12 174410 272 50430430
Aspirin-exacerbated respiratory disease 19.01 9.66 19 174403 855 50429847
Lip oedema 18.87 9.66 37 174385 3156 50427546
Cerebrovascular accident 18.84 9.66 222 174200 94458 50336244
Wrong technique in product usage process 18.84 9.66 113 174309 55397 50375305
Clostridium difficile colitis 18.80 9.66 20 174402 17722 50412980
Drug reaction with eosinophilia and systemic symptoms 18.76 9.66 44 174378 28380 50402322
Lactic acidosis 18.70 9.66 56 174366 33299 50397403
Depression 18.69 9.66 722 173700 164701 50266001
Disability assessment scale score increased 18.63 9.66 31 174391 2327 50428375
Cardiomyopathy 18.35 9.66 16 174406 15570 50415132
Iritis 18.34 9.66 32 174390 2496 50428206
Nail dystrophy 18.32 9.66 18 174404 793 50429909
Cardiac arrest 18.29 9.66 192 174230 83459 50347243
Anti-transglutaminase antibody 18.25 9.66 5 174417 9 50430693
Seizure 18.21 9.66 291 174131 117583 50313119
Device related infection 18.19 9.66 27 174395 20708 50409994
Joint noise 18.17 9.66 39 174383 3548 50427154
Ankle arthroplasty 18.07 9.66 21 174401 1123 50429579
COVID-19 18.02 9.66 91 174331 46571 50384131
Contraindicated product administered 18.00 9.66 655 173767 148303 50282399
Gallbladder cholesterolosis 17.96 9.66 17 174405 715 50429987
Oedema peripheral 17.94 9.66 411 174011 157550 50273152
Quality of life decreased 17.92 9.66 55 174367 6228 50424474
Oesophageal spasm 17.89 9.66 30 174392 2266 50428436
Metastases to liver 17.81 9.66 26 174396 20078 50410624
Agranulocytosis 17.74 9.66 29 174393 21392 50409310
Kidney infection 17.69 9.66 118 174304 18628 50412074
Hypokalaemia 17.63 9.66 206 174216 87786 50342916
Loss of personal independence in daily activities 17.52 9.66 339 174083 69711 50360991
Human anti-human antibody test 17.40 9.66 13 174409 392 50430310
Musculoskeletal discomfort 17.35 9.66 99 174323 14799 50415903
Adverse reaction 17.35 9.66 67 174355 8519 50422183
Crepitations 17.33 9.66 54 174368 6165 50424537
Haematoma 17.26 9.66 51 174371 30459 50400243
Adrenergic syndrome 17.24 9.66 6 174416 31 50430671
Premature labour 17.23 9.66 9 174413 11467 50419235
Hallucination, visual 17.23 9.66 19 174403 16563 50414139
Blood sodium decreased 17.17 9.66 29 174393 21118 50409584
Constipation 17.15 9.66 498 173924 185210 50245492
HLA marker study positive 17.03 9.66 10 174412 199 50430503
Lipidosis 17.01 9.66 5 174417 13 50430689
Intentional overdose 16.84 9.66 306 174116 62198 50368504
Mucosal inflammation 16.84 9.66 76 174346 40066 50390636
Hot flush 16.75 9.66 229 174193 43940 50386762
Dyspepsia 16.67 9.66 353 174069 73744 50356958
Libido increased 16.67 9.66 21 174401 1222 50429480
Costovertebral angle tenderness 16.63 9.66 7 174415 65 50430637
Ventricular tachycardia 16.58 9.66 18 174404 15803 50414899
Blood pressure diastolic abnormal 16.49 9.66 70 174352 9291 50421411
Product quality issue 16.45 9.66 53 174369 30805 50399897
Gastroenteritis viral 16.39 9.66 116 174306 18670 50412032
Electrocardiogram QT prolonged 16.38 9.66 108 174314 51778 50378924
Ileus 16.29 9.66 13 174409 13216 50417486
Sputum discoloured 16.25 9.66 90 174332 13305 50417397
Urticaria 16.21 9.66 572 173850 128989 50301713
Metastases to bone 16.21 9.66 23 174399 17972 50412730
Nail psoriasis 16.18 9.66 12 174410 358 50430344
Antinuclear antibody positive 16.15 9.66 53 174369 6219 50424483
Tumour lysis syndrome 16.15 9.66 3 174419 7418 50423284
Left ventricular dysfunction 16.13 9.66 8 174414 10498 50420204
Medication overuse headache 16.06 9.66 15 174407 620 50430082
Anomaly of external ear congenital 16.03 9.66 9 174413 164 50430538
Pancreatitis 15.95 9.66 84 174338 42530 50388172
Cytokine release syndrome 15.84 9.66 5 174417 8629 50422073
Blood pressure fluctuation 15.81 9.66 191 174231 35632 50395070
Urosepsis 15.77 9.66 18 174404 15447 50415255
Anaphylactic reaction 15.77 9.66 268 174154 53787 50376915
Blood creatinine increased 15.77 9.66 177 174245 75983 50354719
Bone density increased 15.65 9.66 13 174409 459 50430243
Bacteraemia 15.60 9.66 16 174406 14417 50416285
Amblyopia 15.60 9.66 10 174412 234 50430468
Collagen-vascular disease 15.59 9.66 7 174415 77 50430625
Transfusion 15.49 9.66 13 174409 12892 50417810
IIIrd nerve injury 15.47 9.66 4 174418 5 50430697
Cerebral infarction 15.44 9.66 32 174390 21572 50409130
Vaginal infection 15.44 9.66 52 174370 6184 50424518
Red blood cell count decreased 15.20 9.66 181 174241 33654 50397048
Spinal cord infection 15.11 9.66 14 174408 573 50430129
No adverse event 15.04 9.66 62 174360 33516 50397186
Intestinal obstruction 15.00 9.66 44 174378 26339 50404363
Abdominal pain 15.00 9.66 975 173447 235253 50195449
Cardiotoxicity 14.96 9.66 3 174419 7024 50423678
Diabetes mellitus inadequate control 14.87 9.66 14 174408 13131 50417571
Oesophageal pain 14.81 9.66 31 174391 2771 50427931
Parkinsonism 14.74 9.66 6 174416 8841 50421861
Rales 14.73 9.66 8 174414 9970 50420732
Blood glucose increased 14.67 9.66 166 174256 71158 50359544
Discomfort 14.66 9.66 274 174148 108106 50322596
Blood pressure systolic abnormal 14.65 9.66 59 174363 7647 50423055
Tendon rupture 14.64 9.66 56 174366 7088 50423614
Tendon disorder 14.64 9.66 46 174376 5276 50425426
Accidental exposure to product by child 14.63 9.66 18 174404 1022 50429680
Blood alkaline phosphatase increased 14.60 9.66 73 174349 37453 50393249
Dysmenorrhoea 14.54 9.66 34 174388 3276 50427426
Blister 14.52 9.66 207 174215 85211 50345491
Laboratory test abnormal 14.47 9.66 37 174385 23171 50407531
Atrial fibrillation 14.46 9.66 255 174167 101490 50329212
Limb asymmetry 14.44 9.66 16 174406 812 50429890
Kounis syndrome 14.42 9.66 19 174403 1156 50429546
Macular degeneration 14.39 9.66 17 174405 14371 50416331
Bronchospasm 14.39 9.66 18 174404 14836 50415866
Cholesterosis 14.36 9.66 12 174410 427 50430275
Aspergillus infection 14.34 9.66 3 174419 6818 50423884
Hepatic cytolysis 14.33 9.66 5 174417 8098 50422604
Fixed eruption 14.26 9.66 16 174406 823 50429879
Meningitis streptococcal 14.23 9.66 8 174414 146 50430556
Genitourinary symptom 14.22 9.66 6 174416 56 50430646
Haemorrhage intracranial 14.21 9.66 13 174409 12361 50418341
Pre-eclampsia 14.16 9.66 5 174417 8039 50422663
Radiation associated pain 14.13 9.66 6 174416 57 50430645
Endodontic procedure 14.08 9.66 30 174392 2716 50427986
Pre-existing condition improved 14.03 9.66 55 174367 7042 50423660
Pruritus 14.02 9.66 817 173605 282751 50147951
Back pain 13.94 9.66 908 173514 219122 50211580
Rheumatoid lung 13.89 9.66 28 174394 2437 50428265
Prescribed overdose 13.84 9.66 92 174330 14508 50416194
Basal cell carcinoma 13.79 9.66 132 174290 23224 50407478
Blood potassium increased 13.77 9.66 22 174400 16376 50414326
Bone marrow oedema syndrome 13.72 9.66 4 174418 10 50430692
Chronic obstructive pulmonary disease 13.65 9.66 118 174304 53317 50377385
Post-traumatic neck syndrome 13.63 9.66 24 174398 1886 50428816
Pericardial effusion 13.61 9.66 44 174378 25545 50405157
Haematocrit decreased 13.53 9.66 182 174240 34794 50395908
Hostility 13.51 9.66 23 174399 1759 50428943
Poor quality sleep 13.50 9.66 101 174321 16545 50414157
Balance disorder 13.48 9.66 167 174255 70423 50360279
Tooth hypoplasia 13.44 9.66 6 174416 65 50430637
Metabolic surgery 13.33 9.66 17 174405 1001 50429701
Short stature 13.21 9.66 10 174412 308 50430394
Suicidal ideation 13.16 9.66 266 174156 55119 50375583
Single umbilical artery 13.11 9.66 9 174413 237 50430465
Cyanosis 13.10 9.66 20 174402 15164 50415538
Feeling abnormal 13.07 9.66 543 173879 124949 50305753
Aortic valve calcification 13.06 9.66 11 174411 396 50430306
Hypoalbuminaemia 13.03 9.66 9 174413 9851 50420851
Septic arthritis staphylococcal 13.01 9.66 11 174411 398 50430304
Oliguria 13.01 9.66 6 174416 8210 50422492
Spleen congestion 13.00 9.66 7 174415 117 50430585
Duodenal ulcer perforation 12.90 9.66 98 174324 45513 50385189
Bronchopulmonary aspergillosis 12.89 9.66 5 174417 7587 50423115
Acute respiratory distress syndrome 12.88 9.66 34 174388 21065 50409637
Prothrombin time ratio decreased 12.85 9.66 11 174411 405 50430297
Hypocoagulable state 12.85 9.66 16 174406 920 50429782
Sternal fracture 12.82 9.66 24 174398 1978 50428724
Diarrhoea 12.68 9.66 1807 172615 586669 49844033
Metastases to fallopian tube 12.63 9.66 5 174417 39 50430663
Pleural effusion 12.60 9.66 201 174221 81253 50349449
Arrhythmia 12.57 9.66 65 174357 33067 50397635
Hepatic enzyme abnormal 12.51 9.66 41 174381 4808 50425894
Polyneuropathy 12.50 9.66 14 174408 12117 50418585
Oesophageal atresia 12.47 9.66 12 174410 515 50430187
Hepatic encephalopathy 12.46 9.66 9 174413 9627 50421075
Circulatory collapse 12.38 9.66 32 174390 19968 50410734
Extra dose administered 12.28 9.66 42 174380 5034 50425668
Uveitis 12.28 9.66 64 174358 9246 50421456
Subdural haematoma 12.22 9.66 16 174406 12931 50417771
Interstitial lung disease 12.18 9.66 254 174168 52922 50377780
Blood calcium decreased 12.16 9.66 34 174388 20672 50410030
Metastases to lung 12.16 9.66 12 174410 11008 50419694
Lymphopenia 12.15 9.66 22 174400 15599 50415103
Dandruff 12.09 9.66 8 174414 198 50430504
Normal newborn 12.06 9.66 4 174418 6687 50424015
Joint ankylosis 12.03 9.66 14 174408 750 50429952
Polymenorrhagia 12.01 9.66 5 174417 45 50430657
Colostomy infection 11.95 9.66 3 174419 3 50430699
Wrong product procured 11.95 9.66 3 174419 3 50430699
Cushingoid 11.94 9.66 50 174372 6595 50424107
Endometriosis 11.93 9.66 36 174386 4039 50426663
Depressed level of consciousness 11.86 9.66 118 174304 51835 50378867
Blood albumin decreased 11.84 9.66 17 174405 13219 50417483
Nasal ulcer 11.82 9.66 21 174401 1662 50429040
Plantar fasciitis 11.75 9.66 29 174393 2892 50427810
Eosinophil count increased 11.75 9.66 8 174414 8822 50421880
Sinus bradycardia 11.73 9.66 17 174405 13166 50417536
Enterocolitis 11.70 9.66 4 174418 6563 50424139
Gastritis 11.70 9.66 169 174253 32814 50397888
Eating disorder 11.66 9.66 92 174330 15317 50415385
Acquired cystic kidney disease 11.64 9.66 5 174417 49 50430653
Claustrophobia 11.62 9.66 13 174409 667 50430035
Pemphigoid 11.62 9.66 3 174419 5904 50424798
Trigger finger 11.60 9.66 34 174388 3754 50426948
Lower respiratory tract infection 11.58 9.66 419 174003 94782 50335920
Blood lactate dehydrogenase increased 11.58 9.66 32 174390 19530 50411172
Diabetic ketoacidosis 11.53 9.66 28 174394 17844 50412858
Rheumatoid factor positive 11.49 9.66 113 174309 49746 50380956
Injection site reaction 11.46 9.66 239 174183 49793 50380909
Sinus congestion 11.46 9.66 85 174337 13886 50416816
Dysphagia 11.43 9.66 193 174229 77325 50353377
Completed suicide 11.41 9.66 560 173862 131329 50299373
Clostridium difficile infection 11.38 9.66 47 174375 25392 50405310
Cholestasis 11.32 9.66 47 174375 25354 50405348
Cardio-respiratory arrest 11.25 9.66 125 174297 53767 50376935
Full blood count abnormal 11.23 9.66 42 174380 23346 50407356
Live birth 11.15 9.66 25 174397 16383 50414319
Gastrointestinal submucosal tumour 11.14 9.66 4 174418 23 50430679
Blood potassium decreased 11.12 9.66 78 174344 36867 50393835
Product dose omission issue 11.10 9.66 519 173903 183319 50247383
Complication associated with device 11.08 9.66 21 174401 14634 50416068
Ventricular fibrillation 11.08 9.66 12 174410 10547 50420155
Therapeutic product effect variable 10.94 9.66 16 174406 1074 50429628
Ill-defined disorder 10.93 9.66 128 174294 54526 50376176
Mouth ulceration 10.91 9.66 146 174276 27878 50402824
Congenital choroid plexus cyst 10.87 9.66 9 174413 316 50430386
Sudden death 10.86 9.66 9 174413 8982 50421720
Fine motor skill dysfunction 10.86 9.66 35 174387 4068 50426634
Epistaxis 10.86 9.66 155 174267 63799 50366903
Pulmonary oedema 10.82 9.66 112 174310 48826 50381876
Malnutrition 10.79 9.66 18 174404 13171 50417531
Fluid retention 10.76 9.66 117 174305 50532 50380170
Hypohidrosis 10.73 9.66 4 174418 26 50430676
Biliary colic 10.70 9.66 30 174392 3229 50427473
Eosinophilia 10.68 9.66 31 174391 18621 50412081
Anal abscess 10.64 9.66 33 174389 3758 50426944
Analgesic drug level above therapeutic 10.62 9.66 7 174415 172 50430530
Spinal osteoarthritis 10.59 9.66 84 174338 14008 50416694
Oral candidiasis 10.52 9.66 27 174395 16888 50413814
Tracheo-oesophageal fistula 10.51 9.66 11 174411 523 50430179
Failure of child resistant product closure 10.47 9.66 4 174418 28 50430674
Therapy cessation 10.46 9.66 50 174372 25961 50404741
Pseudodementia 10.33 9.66 5 174417 66 50430636
Respiratory disorder 10.31 9.66 64 174358 31123 50399579
Inflammatory pain 10.28 9.66 13 174409 759 50429943
Ischaemic stroke 10.27 9.66 25 174397 15923 50414779
Pneumocystis jirovecii pneumonia 10.24 9.66 22 174400 14641 50416061
Antimitochondrial antibody positive 10.20 9.66 5 174417 68 50430634
Kyphoscoliosis 10.17 9.66 10 174412 441 50430261
Aggression 10.09 9.66 38 174384 21078 50409624
Faecaloma 10.06 9.66 6 174416 7102 50423600
Pancreatitis acute 10.04 9.66 45 174377 23767 50406935
Palindromic rheumatism 10.02 9.66 6 174416 124 50430578
Vaginal abscess 10.01 9.66 9 174413 354 50430348
Supraventricular tachycardia 9.99 9.66 18 174404 12783 50417919
Exposure via skin contact 9.98 9.66 7 174415 191 50430511
Gastric disorder 9.93 9.66 150 174272 29398 50401304
Gastrointestinal bacterial infection 9.91 9.66 12 174410 670 50430032
Staphylococcal sepsis 9.87 9.66 6 174416 7030 50423672
Coarctation of the aorta 9.87 9.66 11 174411 562 50430140
Small intestinal haemorrhage 9.85 9.66 21 174401 1902 50428800
Infusion related reaction 9.77 9.66 481 173941 169076 50261626
Bronchitis viral 9.73 9.66 14 174408 926 50429776
Renal colic 9.69 9.66 16 174406 1193 50429509
Duodenitis 9.69 9.66 29 174393 3239 50427463
Blood urea increased 9.68 9.66 45 174377 23540 50407162

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
Ankylosing spondylitis 297.24 10.51 158 66494 4018 29503857
Gastric haemorrhage 258.94 10.51 194 66458 9103 29498772
Duodenal ulcer 183.18 10.51 158 66494 9080 29498795
Joint swelling 170.79 10.51 358 66294 49272 29458603
Psoriatic arthropathy 158.04 10.51 180 66472 14511 29493364
Arthralgia 153.52 10.51 672 65980 138945 29368930
Gastrointestinal haemorrhage 122.49 10.51 426 66226 79107 29428768
Pain 122.38 10.51 731 65921 170701 29337174
Musculoskeletal stiffness 119.39 10.51 262 66390 37196 29470679
Psoriasis 117.32 10.51 238 66414 31989 29475886
Upper gastrointestinal haemorrhage 115.53 10.51 190 66462 21724 29486151
Acne cystic 111.35 10.51 42 66610 455 29507420
Off label use 100.03 10.51 346 66306 300454 29207421
Neutropenia 96.22 10.51 93 66559 131618 29376257
Gastric ulcer 95.34 10.51 137 66515 13924 29493951
Melaena 94.76 10.51 214 66438 30962 29476913
Death 90.78 10.51 430 66222 341654 29166221
Duodenal ulcer haemorrhage 79.58 10.51 72 66580 4407 29503468
Rheumatoid arthritis 78.71 10.51 203 66449 31949 29475926
Febrile neutropenia 75.47 10.51 85 66567 112155 29395720
Milk-alkali syndrome 74.89 10.51 32 66620 490 29507385
Pain in extremity 72.39 10.51 461 66191 109972 29397903
Completed suicide 68.21 10.51 391 66261 89855 29418020
Faeces discoloured 67.99 10.51 114 66538 13237 29494638
Haematemesis 64.99 10.51 160 66492 24466 29483409
Gastric ulcer haemorrhage 62.91 10.51 66 66586 4848 29503027
Pancytopenia 59.21 10.51 60 66592 83108 29424767
Arthritis 58.20 10.51 155 66497 24864 29483011
Thrombocytopenia 57.14 10.51 138 66514 134685 29373190
Neck pain 53.09 10.51 136 66516 21311 29486564
Peptic ulcer 52.31 10.51 44 66608 2441 29505434
Congenital hiatus hernia 50.21 10.51 23 66629 419 29507456
Sepsis 49.38 10.51 161 66491 142521 29365354
Sacroiliitis 49.10 10.51 31 66621 1096 29506779
Cardiac failure 48.05 10.51 65 66587 79222 29428653
Disability 47.29 10.51 54 66598 4362 29503513
General physical health deterioration 47.03 10.51 101 66551 102756 29405119
Lip swelling 46.74 10.51 93 66559 12317 29495558
Leukopenia 43.83 10.51 36 66616 55167 29452708
Musculoskeletal discomfort 41.83 10.51 61 66591 6280 29501595
Angioedema 41.52 10.51 162 66490 31753 29476122
Back pain 41.13 10.51 381 66271 101903 29405972
Duodenal ulcer perforation 40.97 10.51 31 66621 1475 29506400
Pneumonia 40.41 10.51 495 66157 319677 29188198
Product use in unapproved indication 39.96 10.51 85 66567 86790 29421085
Septic shock 39.22 10.51 50 66602 62510 29445365
Muscle swelling 38.99 10.51 18 66634 334 29507541
Gastritis 38.59 10.51 114 66538 19403 29488472
Drug hypersensitivity 38.43 10.51 275 66377 68131 29439744
Cytomegalovirus infection 38.05 10.51 4 66648 23211 29484664
Lymphocyte count abnormal 37.09 10.51 21 66631 606 29507269
Arthropathy 36.24 10.51 119 66533 21435 29486440
Osteoarthritis 36.04 10.51 106 66546 17997 29489878
Withdrawal arrhythmia 34.97 10.51 10 66642 40 29507835
Drug resistance 34.58 10.51 4 66648 21536 29486339
Gastrointestinal ulcer 34.46 10.51 29 66623 1610 29506265
Seronegative arthritis 34.33 10.51 23 66629 901 29506974
Gastritis erosive 34.31 10.51 51 66601 5342 29502533
Abdominal discomfort 33.85 10.51 204 66448 47699 29460176
Synovitis 33.34 10.51 75 66577 10815 29497060
Atrial fibrillation 33.30 10.51 124 66528 105522 29402353
Accidental exposure to product by child 32.76 10.51 26 66626 1328 29506547
Gastrointestinal fistula 32.23 10.51 16 66636 351 29507524
Bradycardia 32.06 10.51 62 66590 65567 29442308
Eye swelling 30.37 10.51 63 66589 8594 29499281
Renal papillary necrosis 30.35 10.51 12 66640 149 29507726
Back disorder 29.08 10.51 50 66602 5923 29501952
Glomerulonephritis membranous 28.68 10.51 21 66631 950 29506925
Joint injury 28.60 10.51 54 66598 6879 29500996
Exposure to communicable disease 28.38 10.51 11 66641 129 29507746
C-reactive protein abnormal 28.33 10.51 52 66600 6484 29501391
Diverticulitis 28.21 10.51 96 66556 17608 29490267
Urticaria 27.44 10.51 214 66438 54446 29453429
Peripheral swelling 27.42 10.51 241 66411 63498 29444377
Pyrexia 27.36 10.51 470 66182 287152 29220723
Hypoglycaemia 26.95 10.51 42 66610 48304 29459571
Metabolic alkalosis 26.25 10.51 22 66630 1214 29506661
Fibromyalgia 26.23 10.51 31 66621 2598 29505277
Drug ineffective 25.58 10.51 1030 65622 362140 29145735
Pseudoporphyria 25.20 10.51 13 66639 310 29507565
Hypokalaemia 24.89 10.51 47 66605 50156 29457719
Musculoskeletal disorder 24.39 10.51 43 66609 5197 29502678
Drug abuse 24.36 10.51 95 66557 79788 29428087
Obstructive pancreatitis 24.36 10.51 14 66638 416 29507459
Hyponatraemia 24.28 10.51 75 66577 67558 29440317
Musculoskeletal pain 24.20 10.51 129 66523 28824 29479051
Uveitis 24.14 10.51 46 66606 5901 29501974
Gastroduodenal ulcer 23.88 10.51 13 66639 347 29507528
Penile swelling 23.57 10.51 17 66635 751 29507124
Mucosal inflammation 23.38 10.51 22 66630 31573 29476302
Joint stiffness 23.36 10.51 60 66592 9413 29498462
Enthesopathy 23.24 10.51 35 66617 3708 29504167
Energy increased 23.04 10.51 20 66632 1158 29506717
Drug interaction 23.03 10.51 310 66342 197075 29310800
Exostosis 22.92 10.51 34 66618 3555 29504320
Hospitalisation 22.84 10.51 43 66609 45945 29461930
Nasopharyngitis 22.83 10.51 220 66432 59445 29448430
Dactylitis 22.77 10.51 16 66636 678 29507197
Acute biphenotypic leukaemia 22.62 10.51 8 66644 71 29507804
Tendon pain 22.53 10.51 28 66624 2472 29505403
Rectal haemorrhage 22.44 10.51 144 66508 34405 29473470
Tendonitis 22.36 10.51 53 66599 7908 29499967
Migraine 22.13 10.51 70 66582 12360 29495515
Therapeutic product effect incomplete 22.05 10.51 158 66494 39147 29468728
Abdominal pain upper 21.93 10.51 222 66430 60771 29447104
Neck injury 21.92 10.51 19 66633 1098 29506777
White blood cell count decreased 21.84 10.51 105 66547 83257 29424618
Loss of personal independence in daily activities 21.71 10.51 114 66538 25326 29482549
Neutrophil count decreased 21.41 10.51 41 66611 43526 29464349
Fracture 21.18 10.51 44 66608 6009 29501866
Steatorrhoea 20.48 10.51 15 66637 679 29507196
Respiratory tract malformation 20.39 10.51 4 66648 0 29507875
Ascites 20.23 10.51 32 66620 36587 29471288
Diverticular perforation 20.11 10.51 29 66623 2955 29504920
Discomfort 20.06 10.51 76 66576 14687 29493188
Hepatitis B core antibody positive 20.02 10.51 11 66641 299 29507576
Platelet count decreased 19.91 10.51 146 66506 104526 29403349
Sensitivity to weather change 19.86 10.51 20 66632 1399 29506476
Failure of child resistant product closure 19.74 10.51 6 66646 31 29507844
Lipoma 19.72 10.51 20 66632 1411 29506464
Depression 19.69 10.51 285 66367 84862 29423013
Eosinophilic pneumonia 19.68 10.51 28 66624 2818 29505057
Gastrooesophageal reflux disease 19.67 10.51 130 66522 31366 29476509
Neuroleptic malignant syndrome 19.58 10.51 6 66646 16142 29491733
Grip strength decreased 19.46 10.51 25 66627 2282 29505593
Anxiety 19.45 10.51 285 66367 85080 29422795
Gamma-glutamyltransferase increased 19.34 10.51 19 66633 26718 29481157
Insomnia 19.32 10.51 294 66358 88467 29419408
Hepatic function abnormal 19.24 10.51 37 66615 39222 29468653
Dyspepsia 19.22 10.51 125 66527 30000 29477875
Hiatus hernia 19.02 10.51 45 66607 6707 29501168
Acute myeloid leukaemia 18.53 10.51 7 66645 16506 29491369
Gangrene neonatal 18.36 10.51 9 66643 192 29507683
Swollen tongue 18.23 10.51 65 66587 12201 29495674
Vanishing bile duct syndrome 18.01 10.51 13 66639 575 29507300
Myelosuppression 17.91 10.51 3 66649 12224 29495651
Influenza like illness 17.78 10.51 105 66547 24365 29483510
Blood bilirubin unconjugated 17.63 10.51 4 66648 4 29507871
Rash pruritic 17.59 10.51 98 66554 22265 29485610
Spinal osteoarthritis 17.51 10.51 42 66610 6314 29501561
Gastric ulcer perforation 17.33 10.51 15 66637 865 29507010
Nervous system neoplasm 17.30 10.51 8 66644 149 29507726
Mycobacterium tuberculosis complex test positive 17.17 10.51 16 66636 1017 29506858
Headache 17.07 10.51 513 66139 173494 29334381
Skin turgor decreased 16.90 10.51 11 66641 410 29507465
Incorrect dosage administered 16.90 10.51 15 66637 895 29506980
Ulcer haemorrhage 16.86 10.51 24 66628 2417 29505458
Back injury 16.75 10.51 29 66623 3455 29504420
Tuberculin test positive 16.65 10.51 16 66636 1057 29506818
Weight decrease neonatal 16.65 10.51 10 66642 323 29507552
Spinal pain 16.60 10.51 35 66617 4829 29503046
Oesophageal injury 16.59 10.51 5 66647 25 29507850
Swelling face 16.55 10.51 90 66562 20260 29487615
Throat tightness 16.55 10.51 44 66608 7047 29500828
Joint effusion 16.53 10.51 32 66620 4152 29503723
Swelling 16.53 10.51 136 66516 35147 29472728
Oral pustule 16.47 10.51 9 66643 242 29507633
Chronic pigmented purpura 16.45 10.51 7 66645 106 29507769
Respiratory failure 16.37 10.51 140 66512 96991 29410884
Iritis 16.29 10.51 17 66635 1241 29506634
Skin irritation 16.28 10.51 33 66619 4428 29503447
Bone marrow failure 16.12 10.51 23 66629 27426 29480449
Electrocardiogram QT prolonged 16.07 10.51 36 66616 36101 29471774
Inappropriate schedule of product administration 16.04 10.51 162 66490 44310 29463565
Tracheal atresia 16.01 10.51 4 66648 8 29507867
Lymphocyte count decreased 16.00 10.51 12 66640 19259 29488616
Peptic ulcer perforation 15.81 10.51 8 66644 183 29507692
Therapeutic response shortened 15.80 10.51 34 66618 4757 29503118
Respiratory arrest 15.75 10.51 106 66546 25727 29482148
Kounis syndrome 15.71 10.51 20 66632 1809 29506066
Disease progression 15.70 10.51 114 66538 81802 29426073
Neck mass 15.67 10.51 18 66634 1463 29506412
Foetal exposure during pregnancy 15.67 10.51 33 66619 33834 29474041
Blood cholesterol increased 15.52 10.51 73 66579 15522 29492353
Diverticulum 15.50 10.51 40 66612 6292 29501583
Impaired work ability 15.25 10.51 37 66615 5603 29502272
Moaning 15.20 10.51 13 66639 738 29507137
Congenital umbilical hernia 15.17 10.51 9 66643 284 29507591
COVID-19 15.11 10.51 37 66615 35977 29471898
Status epilepticus 15.05 10.51 3 66649 10791 29497084
Joint space narrowing 14.93 10.51 6 66646 78 29507797
Pulmonary fibrosis 14.82 10.51 72 66580 15510 29492365
Hand deformity 14.80 10.51 21 66631 2109 29505766
Neuralgia 14.79 10.51 56 66596 10818 29497057
Burning sensation 14.70 10.51 73 66579 15865 29492010
Epilepsy 14.65 10.51 12 66640 18420 29489455
Aspergillus infection 14.63 10.51 3 66649 10578 29497297
Hypervolaemia 14.47 10.51 11 66641 17534 29490341
Pneumonia aspiration 14.45 10.51 39 66613 36698 29471177
Lactic acidosis 14.39 10.51 29 66623 30218 29477657
Syndesmophyte 14.19 10.51 4 66648 15 29507860
Hypoaesthesia 13.99 10.51 183 66469 53284 29454591
Bacteraemia 13.77 10.51 10 66642 16313 29491562
Confusional state 13.76 10.51 204 66448 127673 29380202
Ulcer 13.76 10.51 41 66611 7010 29500865
Hepatotoxicity 13.75 10.51 12 66640 17855 29490020
Haemangioma 13.73 10.51 18 66634 1676 29506199
Application site haematoma 13.70 10.51 5 66647 49 29507826
Post-traumatic neck syndrome 13.53 10.51 6 66646 101 29507774
Oral pruritus 13.50 10.51 8 66644 252 29507623
Peripheral artery thrombosis 13.40 10.51 20 66632 2102 29505773
Blood pressure systolic increased 13.36 10.51 74 66578 16771 29491104
Lumbar radiculopathy 13.34 10.51 12 66640 729 29507146
Loss of proprioception 13.16 10.51 9 66643 365 29507510
Venous angioma of brain 13.11 10.51 4 66648 21 29507854
Rhinalgia 13.03 10.51 9 66643 371 29507504
Mobility decreased 12.96 10.51 101 66551 25679 29482196
Encephalopathy 12.94 10.51 32 66620 31011 29476864
Renal failure 12.83 10.51 189 66463 118410 29389465
Seizure 12.83 10.51 141 66511 92982 29414893
Paraesthesia 12.74 10.51 181 66471 53664 29454211
Priapism 12.73 10.51 30 66622 4458 29503417
Bronchopulmonary aspergillosis 12.62 10.51 6 66646 12338 29495537
Injection site rash 12.58 10.51 26 66626 3538 29504337
Helicobacter test positive 12.47 10.51 11 66641 651 29507224
Hypocalcaemia 12.45 10.51 17 66635 20648 29487227
Alcohol use 12.43 10.51 24 66628 3108 29504767
Pleural effusion 12.40 10.51 103 66549 71805 29436070
Lymphocyte count 12.30 10.51 5 66647 67 29507808
Local reaction 12.30 10.51 5 66647 67 29507808
Polyneuropathy 12.28 10.51 6 66646 12146 29495729
Neurotoxicity 12.26 10.51 9 66643 14604 29493271
Clumsiness 12.20 10.51 16 66636 1490 29506385
Transient ischaemic attack 12.16 10.51 92 66560 23178 29484697
Acne 12.15 10.51 47 66605 9173 29498702
Oxygen saturation decreased 12.11 10.51 56 66596 44881 29462994
Proctitis ulcerative 12.11 10.51 5 66647 70 29507805
Renal impairment 12.07 10.51 121 66531 81212 29426663
Inflammatory marker increased 12.07 10.51 26 66626 3641 29504234
Ligament calcification 12.03 10.51 7 66645 213 29507662
Fibromuscular dysplasia 12.01 10.51 3 66649 6 29507869
Drug intolerance 12.00 10.51 164 66488 48215 29459660
Acute respiratory failure 11.99 10.51 26 66626 26376 29481499
Agranulocytosis 11.98 10.51 17 66635 20323 29487552
Gait disturbance 11.97 10.51 232 66420 73117 29434758
Tandem gait test abnormal 11.90 10.51 4 66648 30 29507845
Nail injury 11.78 10.51 4 66648 31 29507844
Vitamin B12 increased 11.74 10.51 7 66645 223 29507652
Oedema mouth 11.71 10.51 14 66638 1187 29506688
Inappropriate antidiuretic hormone secretion 11.67 10.51 5 66647 10927 29496948
Intervertebral disc degeneration 11.62 10.51 32 66620 5232 29502643
Secondary amyloidosis 11.62 10.51 5 66647 78 29507797
Alcoholic hangover 11.41 10.51 3 66649 8 29507867
Orthostatic hypotension 11.37 10.51 21 66631 22608 29485267
Ear congestion 11.33 10.51 9 66643 460 29507415
Lower respiratory tract infection 11.28 10.51 100 66552 26402 29481473
Liver disorder 11.26 10.51 29 66623 27720 29480155
Dystonia 11.16 10.51 4 66648 9745 29498130
Pre-existing condition improved 11.15 10.51 19 66633 2234 29505641
Temperature intolerance 11.13 10.51 22 66630 2899 29504976
Progressive multifocal leukoencephalopathy 11.01 10.51 3 66649 8716 29499159
Penile ulceration 11.00 10.51 8 66644 358 29507517
Nephrolithiasis 10.99 10.51 96 66556 25238 29482637
Intentional overdose 10.99 10.51 134 66518 38394 29469481
Arthroscopy 10.97 10.51 5 66647 90 29507785
Spinal epidural haematoma 10.95 10.51 7 66645 253 29507622
Pneumocystis jirovecii pneumonia 10.94 10.51 13 66639 16766 29491109
Blood glucose increased 10.86 10.51 83 66569 58901 29448974
Renal cortical necrosis 10.83 10.51 6 66646 166 29507709
Arteriosclerosis coronary artery 10.81 10.51 50 66602 10555 29497320
Macrophages increased 10.73 10.51 6 66646 169 29507706
Urine odour abnormal 10.72 10.51 12 66640 948 29506927
Joint lock 10.72 10.51 13 66639 1119 29506756
Joint range of motion decreased 10.69 10.51 34 66618 6020 29501855
Similar reaction on previous exposure to drug 10.55 10.51 4 66648 44 29507831
Lymphopenia 10.52 10.51 9 66643 13524 29494351

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
Rheumatoid arthritis 378.86 9.88 1242 197875 163052 64136563
C-reactive protein abnormal 354.64 9.88 443 198674 28604 64271011
Ankylosing spondylitis 315.41 9.88 236 198881 7998 64291617
Pain 315.34 9.88 2841 196276 550670 63748945
Arthralgia 296.08 9.88 2354 196763 439906 63859709
Red blood cell sedimentation rate abnormal 293.17 9.88 304 198813 16002 64283613
Psoriatic arthropathy 292.46 9.88 499 198618 42782 64256833
Death 282.30 9.88 675 198442 482030 63817585
Synovitis 279.45 9.88 804 198313 98286 64201329
Musculoskeletal stiffness 266.64 9.88 912 198205 122294 64177321
Drug hypersensitivity 249.44 9.88 1416 197701 236399 64063216
Drug ineffective 240.86 9.88 3780 195337 836467 63463148
Arthropathy 235.62 9.88 865 198252 120102 64179513
Joint swelling 234.84 9.88 1296 197821 214086 64085529
Psoriasis 213.06 9.88 593 198524 71110 64228505
Neutropenia 211.63 9.88 257 198860 239367 64060248
Febrile neutropenia 197.66 9.88 173 198944 187484 64112131
Gastric haemorrhage 196.41 9.88 225 198892 13256 64286359
Pain in extremity 191.42 9.88 1593 197524 301492 63998123
Arthritis 186.16 9.88 626 198491 83188 64216427
Pancytopenia 185.25 9.88 106 199011 143203 64156412
Gastric ulcer 180.23 9.88 330 198787 29904 64269711
Rheumatoid nodule 159.29 9.88 196 198921 12455 64287160
Sepsis 156.10 9.88 296 198821 230045 64069570
Pyrexia 154.24 9.88 1051 198066 557593 63742022
Duodenal ulcer 154.01 9.88 206 198911 14229 64285386
Fibromyalgia 152.05 9.88 339 198778 35392 64264223
Cardiac failure 146.79 9.88 116 199001 132257 64167358
Thrombocytopenia 144.40 9.88 296 198821 223505 64076110
Leukopenia 144.07 9.88 66 199051 101176 64198439
Pneumonia 131.54 9.88 1101 198016 558475 63741140
Drug intolerance 125.46 9.88 1001 198116 186991 64112624
Human antichimeric antibody positive 123.00 9.88 68 199049 1348 64298267
Body height below normal 119.90 9.88 73 199044 1745 64297870
Migraine 118.43 9.88 444 198673 62233 64237382
Seronegative arthritis 114.93 9.88 83 199034 2660 64296955
Hyponatraemia 114.80 9.88 175 198942 148164 64151451
Joint laxity 113.23 9.88 77 199040 2237 64297378
Musculoskeletal disorder 112.52 9.88 200 198917 17706 64281909
Impaired work ability 111.50 9.88 182 198935 15037 64284578
Off label use 110.12 9.88 1338 197779 631468 63668147
Confusional state 105.65 9.88 431 198686 260713 64038902
Pharyngitis 104.97 9.88 201 198916 18838 64280777
Gastrointestinal pain 104.61 9.88 123 198994 7451 64292164
Anaemia 104.52 9.88 712 198405 377968 63921647
Drug interaction 102.82 9.88 675 198442 361408 63938207
Upper gastrointestinal haemorrhage 102.33 9.88 289 198828 34931 64264684
Bradycardia 101.94 9.88 129 198988 118090 64181525
Abdominal pain upper 101.90 9.88 904 198213 174126 64125489
Femur fracture 101.04 9.88 282 198835 33853 64265762
Drug abuse 100.67 9.88 158 198959 132216 64167399
Polyarthritis 99.62 9.88 136 198981 9579 64290036
Haematemesis 99.02 9.88 345 198772 46654 64252961
Loose body in joint 96.33 9.88 55 199062 1163 64298452
Duodenal ulcer haemorrhage 96.27 9.88 108 199009 6217 64293398
Dislocation of vertebra 94.70 9.88 78 199039 3046 64296569
Injury 94.67 9.88 383 198734 55609 64244006
Osteoporosis 94.01 9.88 315 198802 41765 64257850
Drug tolerance decreased 93.94 9.88 112 199005 6886 64292729
Hypoaesthesia 92.36 9.88 740 198377 138368 64161247
Lip swelling 91.90 9.88 261 198856 31646 64267969
Gastric ulcer haemorrhage 91.17 9.88 119 198998 8024 64291591
Cytomegalovirus infection 91.16 9.88 6 199111 37193 64262422
Contraindicated product administered 90.12 9.88 606 198511 107223 64192392
Red blood cell sedimentation rate increased 89.47 9.88 255 198862 30980 64268635
Toothache 82.69 9.88 173 198944 17286 64282329
Drug resistance 82.21 9.88 7 199110 35095 64264520
Neck pain 82.05 9.88 392 198725 61141 64238474
Drug tolerance 81.04 9.88 97 199020 5988 64293627
Mobility decreased 80.68 9.88 497 198620 85343 64214272
Ulcer 80.30 9.88 202 198915 22788 64276827
Platelet count decreased 78.83 9.88 260 198857 167451 64132164
Disease progression 77.93 9.88 204 198913 141476 64158139
Musculoskeletal pain 77.87 9.88 473 198644 80821 64218794
Joint destruction 76.79 9.88 74 199043 3562 64296053
Peripheral swelling 76.12 9.88 983 198134 208170 64091445
Therapeutic product effect decreased 75.67 9.88 612 198505 114739 64184876
C-reactive protein increased 75.50 9.88 527 198590 94382 64205233
Tendonitis 74.85 9.88 182 198935 20100 64279515
Shoulder arthroplasty 74.61 9.88 64 199053 2645 64296970
Foot deformity 74.07 9.88 160 198957 16344 64283271
Cholecystitis chronic 73.43 9.88 115 199002 9172 64290443
Pseudoporphyria 73.10 9.88 35 199082 507 64299108
Respiratory tract congestion 72.88 9.88 157 198960 16008 64283607
Foot operation 70.85 9.88 76 199041 4159 64295456
Gastrointestinal haemorrhage 70.70 9.88 671 198446 131641 64167974
Deafness transitory 70.06 9.88 39 199078 784 64298831
Enthesopathy 68.90 9.88 114 199003 9524 64290091
Hypoglycaemia 68.61 9.88 107 199010 89785 64209830
Bone disorder 67.94 9.88 156 198961 16603 64283012
Disability 67.71 9.88 129 198988 12043 64287572
White blood cell count decreased 67.28 9.88 255 198862 157582 64142033
Cardiac failure congestive 65.17 9.88 197 198920 130383 64169232
Atrial fibrillation 65.05 9.88 289 198828 170800 64128815
Multiple fractures 64.13 9.88 86 199031 5954 64293661
Dehydration 63.53 9.88 400 198717 216363 64083252
Nerve injury 63.33 9.88 97 199020 7588 64292027
Respiratory failure 63.27 9.88 269 198848 160914 64138701
Wheelchair user 63.08 9.88 75 199042 4597 64295018
Renal failure 62.59 9.88 318 198799 181370 64118245
Hypotension 62.52 9.88 815 198302 380159 63919456
Malignant neoplasm progression 61.70 9.88 163 198954 112708 64186907
Tenosynovitis stenosans 61.65 9.88 50 199067 1910 64297705
Product use in unapproved indication 60.34 9.88 310 198807 176308 64123307
Orthostatic hypotension 59.74 9.88 35 199082 46703 64252912
Faeces discoloured 59.60 9.88 195 198922 25534 64274081
Renal impairment 59.59 9.88 215 198902 134802 64164813
Nephrolithiasis 59.47 9.88 280 198837 43403 64256212
Systemic lupus erythematosus rash 59.43 9.88 43 199074 1382 64298233
Inflammation 58.80 9.88 374 198743 64926 64234689
Melaena 58.73 9.88 323 198794 53225 64246390
Swelling face 58.40 9.88 347 198770 58819 64240796
Posterior reversible encephalopathy syndrome 58.36 9.88 3 199114 22943 64276672
Mycotic allergy 58.05 9.88 37 199080 961 64298654
Multiple organ dysfunction syndrome 57.31 9.88 144 198973 101269 64198346
Neutrophil count decreased 56.92 9.88 94 199023 77102 64222513
Emotional distress 56.58 9.88 241 198876 35797 64263818
Grip strength decreased 55.32 9.88 116 199001 11608 64288007
Obesity 55.17 9.88 164 198953 20398 64279217
Gastrooesophageal reflux disease 54.99 9.88 442 198675 82701 64216914
Gamma-glutamyltransferase increased 54.39 9.88 42 199075 48468 64251147
Synovial fluid analysis 53.57 9.88 42 199075 1527 64298088
Rash 53.09 9.88 1819 197298 456730 63842885
Drug specific antibody 52.69 9.88 47 199070 2048 64297567
General physical health deterioration 52.57 9.88 392 198725 204033 64095582
Urticaria 52.56 9.88 690 198427 146627 64152988
Hepatic function abnormal 52.54 9.88 73 199044 64240 64235375
Bone density decreased 52.34 9.88 103 199014 9849 64289766
Completed suicide 51.84 9.88 977 198140 223437 64076178
Dactylitis 51.79 9.88 45 199072 1893 64297722
Blood parathyroid hormone decreased 51.15 9.88 86 199031 7280 64292335
Ascites 51.03 9.88 70 199047 61931 64237684
Joint injury 50.56 9.88 171 198946 22776 64276839
Maternal exposure during pregnancy 50.50 9.88 141 198976 95743 64203872
Rash pruritic 49.37 9.88 325 198792 57079 64242536
Fear of injection 49.25 9.88 75 199042 5837 64293778
Osteoporotic fracture 48.98 9.88 58 199059 3540 64296075
Dyspepsia 48.86 9.88 419 198698 79893 64219722
Musculoskeletal discomfort 48.69 9.88 135 198982 16142 64283473
Limb discomfort 48.43 9.88 189 198928 26986 64272629
Synovial cyst 48.31 9.88 86 199031 7621 64291994
Bunion operation 47.63 9.88 30 199087 763 64298852
Dyspnoea 47.48 9.88 1778 197339 716896 63582719
Impaired healing 46.45 9.88 333 198784 60140 64239475
Hypoxia 46.14 9.88 130 198987 88019 64211596
Bone marrow failure 46 9.88 48 199069 47904 64251711
Cartilage atrophy 45.85 9.88 18 199099 155 64299460
Scleritis 45.75 9.88 51 199066 2915 64296700
Neuroleptic malignant syndrome 44.75 9.88 11 199106 24985 64274630
Joint effusion 44.58 9.88 116 199001 13357 64286258
Abdominal discomfort 44.27 9.88 800 198317 181522 64118093
Cytokine release syndrome 44.08 9.88 6 199111 20823 64278792
Myelosuppression 43.62 9.88 10 199107 23820 64275795
Hypervolaemia 43.11 9.88 33 199084 38252 64261363
Neovascularisation 43.10 9.88 32 199085 1071 64298544
Loss of personal independence in daily activities 43.03 9.88 376 198741 72078 64227537
Pleuritic pain 42.83 9.88 84 199033 8012 64291603
Red blood cell sedimentation rate 42.71 9.88 55 199062 3659 64295956
Tenosynovitis 42.40 9.88 105 199012 11728 64287887
Adrenal insufficiency 42.21 9.88 159 198958 22328 64277287
Smear cervix abnormal 42.20 9.88 44 199073 2330 64297285
Encephalopathy 42.09 9.88 73 199044 58746 64240869
Arthrodesis 41.65 9.88 41 199076 2026 64297589
Hospitalisation 41.56 9.88 108 199009 75099 64224516
Congenital hiatus hernia 41.49 9.88 22 199095 400 64299215
Fracture delayed union 41.17 9.88 40 199077 1945 64297670
Sopor 41.15 9.88 20 199097 29641 64269974
Hypomagnesaemia 41.09 9.88 33 199084 37343 64262272
Granuloma skin 40.96 9.88 70 199047 6004 64293611
Milk-alkali syndrome 40.87 9.88 32 199085 1161 64298454
Hyperglycaemia 40.66 9.88 79 199038 60889 64238726
Wrist deformity 40.62 9.88 38 199079 1762 64297853
Accidental exposure to product by child 40.53 9.88 44 199073 2441 64297174
Dizziness 40.06 9.88 1666 197451 428497 63871118
Tongue disorder 39.97 9.88 104 199013 11976 64287639
Panniculitis 39.75 9.88 86 199031 8793 64290822
Sleep disorder due to general medical condition, insomnia type 39.14 9.88 16 199101 26254 64273361
Aspergillus infection 39.10 9.88 3 199114 16376 64283239
Acute myeloid leukaemia 38.90 9.88 18 199099 27445 64272170
Pulmonary arterial hypertension 38.53 9.88 15 199102 25352 64274263
Nasopharyngitis 38.41 9.88 833 198284 195240 64104375
Blood pressure systolic increased 38.37 9.88 273 198844 49180 64250435
Gastritis 38.31 9.88 244 198873 42374 64257241
Agranulocytosis 38.12 9.88 37 199080 38192 64261423
Osteonecrosis of jaw 38.05 9.88 40 199077 39785 64259830
Nodule 38.01 9.88 132 198985 17815 64281800
Ventricular tachycardia 37.99 9.88 30 199087 34235 64265380
Cerebral haemorrhage 37.86 9.88 62 199055 51028 64248587
Cardiogenic shock 37.74 9.88 27 199090 32400 64267215
Myelodysplastic syndrome 37.65 9.88 19 199098 27560 64272055
Hepatotoxicity 37.22 9.88 41 199076 39921 64259694
Tooth disorder 36.87 9.88 152 198965 22250 64277365
Mucosal inflammation 36.82 9.88 87 199030 62497 64237118
Back pain 36.76 9.88 1022 198095 249149 64050466
Acute respiratory failure 36.62 9.88 61 199056 49873 64249742
Wound infection 36.56 9.88 115 199002 14749 64284866
Antibody test positive 36.46 9.88 41 199076 2366 64297249
Lactic acidosis 36.43 9.88 85 199032 61325 64238290
COVID-19 36.41 9.88 93 199024 65047 64234568
Pulmonary hypertension 36.21 9.88 48 199069 43091 64256524
Limb deformity 35.90 9.88 48 199069 3313 64296302
Hypokalaemia 35.66 9.88 225 198892 121678 64177937
Sensitivity to weather change 34.72 9.88 69 199048 6645 64292970
Exposure during pregnancy 34.71 9.88 123 198994 77552 64222063
Neurotoxicity 34.35 9.88 21 199096 27383 64272232
Infection 34.17 9.88 779 198338 184101 64115514
Ear infection 34.06 9.88 153 198964 23251 64276364
Peptic ulcer 33.82 9.88 60 199057 5303 64294312
Right ventricular failure 33.78 9.88 12 199105 21459 64278156
Intestinal diaphragm disease 33.71 9.88 18 199099 332 64299283
Paraesthesia 33.61 9.88 593 198524 133929 64165686
Juvenile idiopathic arthritis 33.44 9.88 50 199067 3829 64295786
Respiratory distress 33.03 9.88 70 199047 52261 64247354
Bronchopulmonary aspergillosis 33.01 9.88 9 199108 19076 64280539
Hunger 32.45 9.88 52 199065 4229 64295386
Sacroiliitis 32.15 9.88 43 199074 2969 64296646
Withdrawal arrhythmia 31.87 9.88 10 199107 40 64299575
Bacteraemia 31.86 9.88 22 199095 26889 64272726
Gastrointestinal ulcer 31.45 9.88 43 199074 3032 64296583
Malaise 31.24 9.88 1509 197608 394738 63904877
Soft tissue injury 31.23 9.88 31 199086 1548 64298067
Septic shock 31.15 9.88 194 198923 105243 64194372
Serum sickness-like reaction 31.03 9.88 20 199097 530 64299085
Neoplasm progression 31.02 9.88 49 199068 40915 64258700
Blood creatine phosphokinase increased 30.91 9.88 86 199031 58472 64241143
Joint range of motion decreased 30.86 9.88 130 198987 19213 64280402
Tenderness 30.70 9.88 131 198986 19471 64280144
International normalised ratio increased 30.51 9.88 133 198984 79034 64220581
Acute respiratory distress syndrome 30.03 9.88 46 199071 38889 64260726
Clostridium difficile colitis 29.97 9.88 24 199093 27199 64272416
Tooth infection 29.73 9.88 106 199011 14495 64285120
Gait inability 29.52 9.88 228 198889 42140 64257475
Gastritis erosive 29.11 9.88 80 199037 9515 64290100
Photophobia 28.99 9.88 118 198999 17175 64282440
Feeding disorder 28.97 9.88 97 199020 12852 64286763
Alanine aminotransferase abnormal 28.90 9.88 65 199052 6823 64292792
Diabetes mellitus inadequate control 28.64 9.88 15 199102 21306 64278309
Arrhythmia 28.51 9.88 77 199040 52867 64246748
Pneumonia aspiration 28.44 9.88 91 199026 59180 64240435
Depression 28.39 9.88 754 198363 182537 64117078
Bursitis 28.00 9.88 136 198981 21349 64278266
Intentional overdose 27.89 9.88 411 198706 89533 64210082
Folliculitis 27.85 9.88 31 199086 30046 64269569
Tendon pain 27.73 9.88 52 199065 4796 64294819
Gallbladder injury 27.39 9.88 25 199092 1123 64298492
Blood glucose increased 27.17 9.88 184 198933 97889 64201726
Functional gastrointestinal disorder 27.06 9.88 47 199070 4084 64295531
Angioedema 27.02 9.88 301 198816 61520 64238095
Subdural haematoma 27.00 9.88 28 199089 28026 64271589
Pleural effusion 26.95 9.88 255 198862 126304 64173311
Tachycardia 26.72 9.88 314 198803 149265 64150350
Hallucination, visual 26.54 9.88 28 199089 27806 64271809
Skin papilloma 26.34 9.88 53 199064 5150 64294465
Headache 26.29 9.88 1935 197182 527532 63772083
Syncope 26.24 9.88 336 198781 157299 64142316
Kounis syndrome 26.09 9.88 39 199078 2986 64296629
Tendon disorder 25.73 9.88 59 199058 6273 64293342
Electrolyte imbalance 25.67 9.88 24 199093 25219 64274396
Blepharospasm 25.59 9.88 41 199076 3334 64296281
Skin fissures 25.59 9.88 80 199037 10226 64289389
Body temperature decreased 25.54 9.88 152 198965 25776 64273839
Device ineffective 25.50 9.88 11 199106 123 64299492
Palmar-plantar erythrodysaesthesia syndrome 25.29 9.88 31 199086 28788 64270827
Polyneuropathy 25.28 9.88 15 199102 19879 64279736
Anxiety 25.19 9.88 811 198306 201838 64097777
Seizure 25.16 9.88 363 198754 166529 64133086
Electrocardiogram QT prolonged 25.15 9.88 143 198974 79305 64220310
Intestinal obstruction 25.09 9.88 46 199071 36240 64263375
Crepitations 25.02 9.88 67 199050 7848 64291767
Circulatory collapse 24.93 9.88 41 199076 33691 64265924
Spondyloarthropathy 24.61 9.88 20 199097 766 64298849
Adjustment disorder with depressed mood 24.59 9.88 34 199083 2423 64297192
Spinal fusion surgery 24.52 9.88 42 199075 3609 64296006
Gastroenteritis viral 24.37 9.88 123 198994 19606 64280009
Nail psoriasis 24.33 9.88 15 199102 367 64299248
Hepatocellular injury 24.20 9.88 66 199051 45169 64254446
Skin necrosis 24.20 9.88 98 199019 14231 64285384
Cerebral infarction 24.19 9.88 57 199060 40987 64258628
Failure of child resistant product closure 24.17 9.88 9 199108 66 64299549
Ankle arthroplasty 24.13 9.88 21 199096 885 64298730
Kidney infection 24.03 9.88 114 199003 17724 64281891
Pharyngeal swelling 23.93 9.88 53 199064 5506 64294109
Ventricular fibrillation 23.90 9.88 23 199094 23837 64275778
Oesophageal spasm 23.87 9.88 34 199083 2491 64297124
Gastroduodenal ulcer 23.73 9.88 16 199101 458 64299157
Periorbital oedema 23.68 9.88 63 199054 7351 64292264
Full blood count decreased 23.52 9.88 21 199096 22561 64277054
Pseudomonas infection 23.41 9.88 13 199104 17870 64281745
Therapy non-responder 23.20 9.88 308 198809 65591 64234024
Ileus 23.16 9.88 22 199095 22944 64276671
Enterococcal infection 23.13 9.88 7 199110 13859 64285756
Pneumocystis jirovecii pneumonia 22.94 9.88 31 199086 27603 64272012
Psychotic disorder 22.89 9.88 45 199072 34533 64265082
Chronic spontaneous urticaria 22.87 9.88 16 199101 487 64299128
Device related infection 22.84 9.88 37 199080 30589 64269026
Lymphocyte count decreased 22.82 9.88 58 199059 40641 64258974
Status epilepticus 22.74 9.88 20 199097 21643 64277972
Diverticulitis 22.71 9.88 200 198917 38418 64261197
Urosepsis 22.47 9.88 21 199096 22073 64277542
Renal papillary necrosis 22.44 9.88 14 199103 350 64299265
Premature delivery 22.27 9.88 15 199102 18574 64281041
Cardiac arrest 22.22 9.88 338 198779 153726 64145889
Blood lactate dehydrogenase increased 21.93 9.88 43 199074 33035 64266580
Plasma cell myeloma 21.92 9.88 71 199046 46004 64253611
Therapeutic response decreased 21.86 9.88 252 198865 51936 64247679
Hepatic cytolysis 21.85 9.88 8 199109 14041 64285574
Pancreatitis 21.85 9.88 102 199015 59505 64240110
Heart rate 21.81 9.88 8 199109 56 64299559
Walking aid user 21.73 9.88 55 199062 6226 64293389
Muscle swelling 21.66 9.88 18 199099 712 64298903
Rhabdomyolysis 21.64 9.88 180 198937 91546 64208069
Trigger finger 21.51 9.88 39 199078 3506 64296109
Adenoiditis 21.39 9.88 7 199110 33 64299582
Extra dose administered 21.20 9.88 57 199060 6693 64292922
Iritis 21.13 9.88 36 199081 3080 64296535
Atrioventricular block complete 21.13 9.88 9 199108 14409 64285206
Incorrect dosage administered 21.09 9.88 30 199087 2196 64297419
Lymphopenia 21.08 9.88 29 199088 25628 64273987
Biliary dyskinesia 21.06 9.88 31 199086 2341 64297274
Skin ulcer 21.03 9.88 218 198899 43756 64255859
Bone lesion 21.02 9.88 48 199069 5089 64294526
Gait disturbance 20.88 9.88 687 198430 171468 64128147
Eosinophilia 20.78 9.88 55 199062 38021 64261594
Drug eruption 20.66 9.88 186 198931 35950 64263665
Haemorrhage intracranial 20.64 9.88 26 199091 23858 64275757
Feeling jittery 20.63 9.88 76 199041 10559 64289056
Tumour lysis syndrome 20.34 9.88 18 199099 19422 64280193
Vaginal infection 20.16 9.88 46 199071 4874 64294741
Haematoma 20.16 9.88 74 199043 46176 64253439
Lower respiratory tract infection 20.15 9.88 407 198710 94207 64205408
Post-traumatic neck syndrome 20.07 9.88 27 199090 1875 64297740
Pericarditis 20.07 9.88 112 199005 62404 64237211
Rales 20.04 9.88 11 199106 15218 64284397
Nail dystrophy 19.97 9.88 18 199099 795 64298820
Blood pressure decreased 19.95 9.88 170 198947 86029 64213586
Feeling abnormal 19.93 9.88 547 198570 133055 64166560
Left ventricular dysfunction 19.88 9.88 14 199103 16940 64282675
Cardiac failure acute 19.83 9.88 13 199104 16331 64283284
Schizophrenia 19.83 9.88 5 199112 11163 64288452
Oedema peripheral 19.77 9.88 496 198621 209821 64089794
Sedation complication 19.65 9.88 4 199113 10350 64289265
Epstein-Barr virus infection 19.61 9.88 7 199110 12481 64287134
Disability assessment scale score increased 19.55 9.88 31 199086 2499 64297116
Gastrointestinal fistula 19.51 9.88 16 199101 621 64298994
Wrong technique in product usage process 19.47 9.88 119 198998 64855 64234760
Sternal fracture 19.42 9.88 29 199088 2218 64297397
Flank pain 19.34 9.88 100 199017 16089 64283526
Pemphigoid 19.20 9.88 8 199109 12978 64286637
Human anti-human antibody test 19.20 9.88 13 199104 375 64299240
Gastric disorder 19.17 9.88 155 198962 29042 64270573
Therapeutic response shortened 19.16 9.88 72 199045 10098 64289517
Joint noise 19.07 9.88 35 199082 3176 64296439
Eye swelling 19.06 9.88 126 198991 22155 64277460
Hepatic enzyme abnormal 19.04 9.88 50 199067 5789 64293826
Ischaemic stroke 19.03 9.88 38 199079 28997 64270618
Cardio-respiratory arrest 18.97 9.88 203 198914 98190 64201425
Limb asymmetry 18.93 9.88 15 199102 554 64299061
Glomerulonephritis membranous 18.90 9.88 22 199095 1318 64298297
Quality of life decreased 18.83 9.88 60 199057 7746 64291869
Swelling 18.82 9.88 637 198480 159581 64140034
Anti-transglutaminase antibody 18.80 9.88 5 199112 9 64299606
Lipidosis 18.46 9.88 5 199112 10 64299605
Colitis 18.35 9.88 106 199011 58568 64241047
Anaphylactic reaction 18.34 9.88 306 198811 68358 64231257
Osteoarthritis 18.31 9.88 286 198831 63050 64236565
Duodenitis 18.30 9.88 54 199063 6687 64292928
Gastric ulcer perforation 18.23 9.88 25 199092 1768 64297847
Drug level increased 18.21 9.88 50 199067 34146 64265469
Myofascial pain syndrome 18.18 9.88 25 199092 1773 64297842
Hyperkalaemia 18.17 9.88 212 198905 100917 64198698
Creatinine renal clearance decreased 18.14 9.88 11 199106 14410 64285205
Hepatic encephalopathy 18.13 9.88 23 199094 21043 64278572
Spinal osteoarthritis 18.13 9.88 90 199027 14251 64285364
Condition aggravated 18.10 9.88 1359 197758 371067 63928548
Labelled drug-drug interaction medication error 18.06 9.88 25 199092 22037 64277578
Mouth ulceration 18.04 9.88 166 198951 32278 64267337
Parkinsonism 18.03 9.88 11 199106 14362 64285253
Aspirin-exacerbated respiratory disease 17.98 9.88 20 199097 1140 64298475
Blood alkaline phosphatase increased 17.97 9.88 101 199016 56178 64243437
Fluid retention 17.95 9.88 109 199008 59497 64240118
Dysstasia 17.91 9.88 128 198989 23087 64276528
Hepatic failure 17.91 9.88 99 199018 55295 64244320
Eosinophilic pneumonia 17.89 9.88 42 199075 4535 64295080
Blood creatinine increased 17.87 9.88 303 198814 135479 64164136
Metastases to liver 17.78 9.88 29 199088 23912 64275703
Joint stiffness 17.64 9.88 157 198960 30247 64269368
Hepatic adenoma 17.59 9.88 11 199106 276 64299339
Neuropathy peripheral 17.57 9.88 256 198861 117269 64182346
Cardiotoxicity 17.48 9.88 5 199112 10269 64289346
Hypophosphataemia 17.47 9.88 12 199105 14708 64284907
Liver disorder 17.44 9.88 95 199022 53256 64246359
Fixed eruption 17.44 9.88 27 199090 2132 64297483
Oesophageal pain 17.44 9.88 34 199083 3229 64296386
Blood pressure diastolic abnormal 17.41 9.88 78 199039 11839 64287776
Amblyopia 17.41 9.88 10 199107 214 64299401
Collagen-vascular disease 17.28 9.88 7 199110 66 64299549
Blood pressure fluctuation 17.26 9.88 240 198877 51631 64247984
Eye pain 17.18 9.88 161 198956 31464 64268151
Fatigue 17.16 9.88 2597 196520 746133 63553482
Inappropriate schedule of product administration 17.08 9.88 389 198728 91897 64207718
Peptic ulcer perforation 17.08 9.88 12 199105 368 64299247
Abnormal loss of weight 17.06 9.88 56 199061 7344 64292271
Decreased appetite 16.92 9.88 703 198414 280586 64019029
Antinuclear antibody positive 16.91 9.88 50 199067 6200 64293415
Endocarditis fibroplastica 16.79 9.88 5 199112 16 64299599
Goitre 16.64 9.88 43 199074 4930 64294685
Blood pressure measurement 16.63 9.88 12 199105 384 64299231
Back disorder 16.61 9.88 68 199049 9922 64289693
Cytopenia 16.58 9.88 14 199103 15457 64284158
Penile swelling 16.56 9.88 14 199103 567 64299048
Blood sodium decreased 16.54 9.88 42 199075 29440 64270175
Lip oedema 16.48 9.88 44 199073 5145 64294470
Renal mass 16.39 9.88 30 199087 2717 64296898
Blood bilirubin unconjugated 16.37 9.88 4 199113 4 64299611
Malnutrition 16.34 9.88 21 199096 19104 64280511
Oxygen saturation decreased 16.18 9.88 233 198884 106943 64192672
Pulmonary oedema 16.11 9.88 160 198957 78514 64221101
Failure to thrive 16.05 9.88 6 199111 10398 64289217
Medication overuse headache 16.04 9.88 15 199102 695 64298920
Abdominal pain 16.04 9.88 1145 197972 311230 63988385
Blood pressure systolic abnormal 16.00 9.88 67 199050 9875 64289740
Rheumatoid lung 15.97 9.88 28 199089 2451 64297164
Radiation associated pain 15.94 9.88 7 199110 82 64299533
Blood bilirubin increased 15.92 9.88 108 199009 57445 64242170
IIIrd nerve injury 15.91 9.88 4 199113 5 64299610
Nausea 15.90 9.88 2707 196410 783093 63516522
Restlessness 15.84 9.88 66 199051 39719 64259896
Rash maculo-papular 15.78 9.88 83 199034 46943 64252672
Depressed level of consciousness 15.70 9.88 168 198949 81268 64218347
Acute biphenotypic leukaemia 15.67 9.88 8 199109 134 64299481
Clostridium difficile infection 15.67 9.88 58 199059 36105 64263510
Neutropenic sepsis 15.65 9.88 30 199087 23242 64276373
Swollen tongue 15.64 9.88 171 198946 34783 64264832
Toxic skin eruption 15.64 9.88 22 199095 19262 64280353
Hostility 15.63 9.88 26 199091 2181 64297434
Localised infection 15.61 9.88 152 198965 30009 64269606
Drug level decreased 15.59 9.88 8 199109 11495 64288120
Myoclonus 15.52 9.88 34 199083 25084 64274531
Bone density increased 15.43 9.88 13 199104 524 64299091
Intervertebral disc protrusion 15.39 9.88 111 199006 20080 64279535
Oropharyngeal pain 15.34 9.88 371 198746 88496 64211119
Disorientation 15.33 9.88 105 199012 55723 64243892
Cystitis haemorrhagic 15.26 9.88 3 199114 7953 64291662
Bradyphrenia 15.24 9.88 5 199112 9401 64290214
Nightmare 15.20 9.88 114 199003 20879 64278736
Joint ankylosis 15.03 9.88 15 199102 754 64298861
Obstructive pancreatitis 14.97 9.88 14 199103 649 64298966
Immunodeficiency 14.91 9.88 93 199024 16031 64283584
Pemphigus 14.83 9.88 118 198999 60583 64239032
Dystonia 14.83 9.88 22 199095 18843 64280772
Endodontic procedure 14.66 9.88 26 199091 2297 64297318
Disseminated intravascular coagulation 14.60 9.88 51 199066 32297 64267318
Progressive multifocal leukoencephalopathy 14.58 9.88 21 199096 18211 64281404
Muscle injury 14.57 9.88 38 199079 26399 64273216
Dysmenorrhoea 14.55 9.88 27 199090 2470 64297145
Clear cell renal cell carcinoma 14.55 9.88 25 199092 2154 64297461
Hypercapnia 14.55 9.88 3 199114 7691 64291924
Hepatocellular carcinoma 14.46 9.88 4 199113 8399 64291216
Expired product administered 14.43 9.88 46 199071 5941 64293674
Alanine aminotransferase increased 14.41 9.88 323 198794 138708 64160907
Ocular hyperaemia 14.39 9.88 119 198998 22445 64277170
Anencephaly 14.35 9.88 3 199114 0 64299615
Sudden death 14.32 9.88 25 199092 20071 64279544
Oesophageal ulcer 14.32 9.88 47 199070 6163 64293452
Uterine perforation 14.28 9.88 45 199072 5775 64293840
Constipation 14.25 9.88 571 198546 228766 64070849
Meningitis streptococcal 14.06 9.88 8 199109 168 64299447
Occult blood positive 13.98 9.88 47 199070 6240 64293375
Aspartate aminotransferase increased 13.97 9.88 273 198844 119515 64180100
Hodgkin's disease 13.91 9.88 15 199102 826 64298789
Pericardial effusion 13.90 9.88 68 199049 39186 64260429
Vision blurred 13.81 9.88 371 198746 89945 64209670
Multiple sclerosis 13.79 9.88 103 199014 18838 64280777
Eye irritation 13.77 9.88 90 199027 15766 64283849
Dementia 13.76 9.88 27 199090 20739 64278876
Tandem gait test abnormal 13.75 9.88 5 199112 34 64299581
Muscle spasms 13.72 9.88 549 198568 140474 64159141
Immune reconstitution inflammatory syndrome 13.72 9.88 11 199106 12459 64287156
Blood cholesterol increased 13.69 9.88 224 198893 49842 64249773
Hyperbilirubinaemia 13.69 9.88 28 199089 21177 64278438
Endometriosis 13.61 9.88 28 199089 2764 64296851
Dry mouth 13.56 9.88 262 198855 60156 64239459
Cholestasis 13.54 9.88 82 199035 44790 64254825
Uveitis 13.49 9.88 76 199041 12632 64286983
Limb operation 13.46 9.88 28 199089 2786 64296829
Aplastic anaemia 13.27 9.88 14 199103 13906 64285709
Hyperammonaemia 13.26 9.88 7 199110 9897 64289718
Unresponsive to stimuli 13.24 9.88 96 199021 50297 64249318
Carpal tunnel syndrome 13.23 9.88 89 199028 15739 64283876
COVID-19 pneumonia 13.21 9.88 19 199098 16485 64283130
Blood potassium decreased 13.17 9.88 72 199045 40327 64259288
Metastases to fallopian tube 13.17 9.88 5 199112 39 64299576
Respiratory acidosis 13.14 9.88 7 199110 9848 64289767
Fall 13.12 9.88 1108 198009 415718 63883897
Cachexia 13.12 9.88 6 199111 9211 64290404
Inappropriate antidiuretic hormone secretion 13.10 9.88 31 199086 22258 64277357
Wound 13.09 9.88 162 198955 76315 64223300
Stomatitis 13.02 9.88 249 198868 109356 64190259
Gallbladder cholesterolosis 12.92 9.88 12 199105 551 64299064
Bronchospasm 12.86 9.88 30 199087 21652 64277963
Treatment noncompliance 12.84 9.88 80 199037 43402 64256213
Bone marrow oedema syndrome 12.75 9.88 4 199113 16 64299599
Atrioventricular block 12.72 9.88 11 199106 12004 64287611
Small intestinal haemorrhage 12.68 9.88 33 199084 3800 64295815
Transaminases increased 12.68 9.88 83 199034 44511 64255104
Peripheral arterial occlusive disease 12.65 9.88 3 199114 6984 64292631
Polymenorrhagia 12.64 9.88 5 199112 44 64299571
Lipoma 12.59 9.88 26 199091 2573 64297042
Short stature 12.58 9.88 9 199108 284 64299331
Libido increased 12.56 9.88 21 199096 1769 64297846
Cholangitis 12.56 9.88 9 199108 10793 64288822
Musculoskeletal chest pain 12.50 9.88 111 199006 21368 64278247
Atelectasis 12.48 9.88 134 198983 27132 64272483
Amnesia 12.48 9.88 214 198903 48055 64251560
Caesarean section 12.33 9.88 10 199107 11264 64288351
Myocarditis 12.33 9.88 21 199096 17022 64282593
Haematocrit decreased 12.27 9.88 237 198880 54418 64245197
Second primary malignancy 12.23 9.88 12 199105 12325 64287290
Nasal ulcer 12.21 9.88 19 199098 1507 64298108
Aggression 12.18 9.88 88 199029 46144 64253471
Hypothyroidism 12.17 9.88 74 199043 40383 64259232
Head injury 12.15 9.88 56 199061 32786 64266829
Troponin increased 12.06 9.88 18 199099 15381 64284234
Congenital bowing of long bones 12.03 9.88 4 199113 20 64299595
Coma 12.02 9.88 194 198923 87421 64212194
Bacterial sepsis 12.02 9.88 4 199113 7453 64292162
Shock 12.00 9.88 69 199048 38171 64261444
Type 2 diabetes mellitus 11.97 9.88 159 198958 33861 64265754
Device expulsion 11.94 9.88 30 199087 21106 64278509
Hypernatraemia 11.92 9.88 12 199105 12177 64287438
Ventricular arrhythmia 11.91 9.88 4 199113 7411 64292204
Vaginal abscess 11.90 9.88 9 199108 310 64299305
Hepatitis 11.89 9.88 87 199030 45495 64254120
Hypertensive crisis 11.86 9.88 24 199093 18224 64281391
Suicidal ideation 11.85 9.88 279 198838 66263 64233352
Sinus congestion 11.84 9.88 85 199032 15354 64284261
Sputum discoloured 11.84 9.88 95 199022 17761 64281854
Eczema infected 11.74 9.88 5 199112 54 64299561
Exposure via skin contact 11.74 9.88 7 199110 161 64299454
Akathisia 11.64 9.88 11 199106 11499 64288116
Staphylococcal bacteraemia 11.56 9.88 9 199108 10346 64289269
Metastases to bone 11.55 9.88 29 199088 20406 64279209
Tardive dyskinesia 11.55 9.88 7 199110 9171 64290444
Energy increased 11.54 9.88 26 199091 2732 64296883
Oral discomfort 11.52 9.88 54 199063 8352 64291263
Diverticulum 11.51 9.88 75 199042 13123 64286492
Acquired cystic kidney disease 11.51 9.88 5 199112 57 64299558
Brain herniation 11.45 9.88 3 199114 6530 64293085
Cardiomyopathy 11.43 9.88 40 199077 25316 64274299
Transfusion 11.41 9.88 24 199093 17970 64281645
Chronic kidney disease 11.36 9.88 119 198998 57800 64241815
Subarachnoid haemorrhage 11.35 9.88 25 199092 18413 64281202
Heparin-induced thrombocytopenia 11.34 9.88 6 199111 8473 64291142
Cushingoid 11.29 9.88 50 199067 7553 64292062
Pulmonary congestion 11.23 9.88 118 198999 23762 64275853
Dialysis 11.21 9.88 22 199095 16898 64282717
Hyperuricaemia 11.20 9.88 9 199108 10182 64289433
Left ventricular failure 11.19 9.88 6 199111 8411 64291204
Lipase increased 11.12 9.88 17 199100 14385 64285230
Chronic pigmented purpura 11.11 9.88 7 199110 178 64299437
Intervertebral disc degeneration 11.11 9.88 74 199043 13046 64286569
Poor quality sleep 11.06 9.88 98 199019 18853 64280762
Blood calcium decreased 11.06 9.88 41 199076 25513 64274102
Neck injury 11.01 9.88 23 199094 2295 64297320
Adrenergic syndrome 10.94 9.88 6 199111 117 64299498
Hyperthyroidism 10.91 9.88 25 199092 18154 64281461
Hot flush 10.89 9.88 202 198915 46033 64253582
Concussion 10.89 9.88 51 199066 7887 64291728
Pulseless electrical activity 10.87 9.88 14 199103 12725 64286890
Eye infection 10.86 9.88 57 199060 9224 64290391
Pneumonia fungal 10.85 9.88 7 199110 8870 64290745
Alcoholic hangover 10.76 9.88 3 199114 7 64299608
Suicidal behaviour 10.75 9.88 26 199091 2861 64296754
Hepatitis cholestatic 10.75 9.88 13 199104 12142 64287473
Oral pustule 10.72 9.88 8 199109 270 64299345
Hypercalcaemia 10.71 9.88 146 198971 31270 64268345
Fallopian tube cancer 10.67 9.88 4 199113 30 64299585
Pre-eclampsia 10.66 9.88 3 199114 6228 64293387
Intestinal ischaemia 10.59 9.88 12 199105 11537 64288078
Cholecystectomy 10.58 9.88 51 199066 7981 64291634
Septic arthritis staphylococcal 10.57 9.88 12 199105 700 64298915
Haemolytic anaemia 10.53 9.88 21 199096 16032 64283583
Pneumonitis 10.49 9.88 102 199015 50263 64249352
Enterocolitis 10.47 9.88 13 199104 12005 64287610
Glycosylated haemoglobin increased 10.47 9.88 21 199096 15998 64283617
Acute coronary syndrome 10.46 9.88 28 199089 19282 64280333
Penile ulceration 10.42 9.88 8 199109 282 64299333
Oesophageal injury 10.41 9.88 5 199112 73 64299542
Application site haematoma 10.41 9.88 5 199112 73 64299542
Hallucination, auditory 10.40 9.88 23 199094 16916 64282699
Sinus bradycardia 10.39 9.88 36 199081 22857 64276758
Basal cell carcinoma 10.39 9.88 143 198974 30695 64268920
Jaundice cholestatic 10.38 9.88 7 199110 8663 64290952
Disease recurrence 10.36 9.88 56 199061 31454 64268161
Inflammatory pain 10.35 9.88 13 199104 843 64298772
Fine motor skill dysfunction 10.33 9.88 35 199082 4664 64294951
Meningitis aseptic 10.33 9.88 40 199077 5690 64293925
Local reaction 10.31 9.88 10 199107 485 64299130
Prescribed overdose 10.30 9.88 102 199015 20229 64279386
Knee arthroplasty 10.27 9.88 128 198989 26871 64272744
Deafness 10.24 9.88 94 199023 18265 64281350
Chronic obstructive pulmonary disease 10.19 9.88 156 198961 70892 64228723
White blood cell count increased 10.14 9.88 143 198974 65871 64233744
Tachyarrhythmia 10.13 9.88 3 199114 6023 64293592
Cholelithiasis 10.10 9.88 197 198920 45309 64254306
Costovertebral angle tenderness 10.10 9.88 7 199110 210 64299405
Post viral fatigue syndrome 10.08 9.88 8 199109 296 64299319
Myopathy 10.06 9.88 25 199092 17655 64281960
Burning sensation 10.03 9.88 212 198905 49452 64250163
Infective pulmonary exacerbation of cystic fibrosis 10.03 9.88 13 199104 11783 64287832
Generalised oedema 10.01 9.88 32 199085 20821 64278794
Ligament calcification 9.98 9.88 7 199110 214 64299401

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC G02CC02 GENITO URINARY SYSTEM AND SEX HORMONES
OTHER GYNECOLOGICALS
OTHER GYNECOLOGICALS
Antiinflammatory products for vaginal administration
ATC M01AE02 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M01AE52 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M01AE56 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M02AA12 MUSCULO-SKELETAL SYSTEM
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Antiinflammatory preparations, non-steroids for topical use
FDA CS M0001335 Anti-Inflammatory Agents, Non-Steroidal
FDA MoA N0000000160 Cyclooxygenase Inhibitors
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006074 Gout Suppressants
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
CHEBI has role CHEBI:35493 anti-pyretic
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:35845 gout suppressants
CHEBI has role CHEBI:50629 COX-2 inhibitor
CHEBI has role CHEBI:50630 COX-1 inhibitor
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:88188 allergenic drug
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Sinus headache indication 4969004
Ankylosing spondylitis indication 9631008 DOID:7147
Pain indication 22253000
Toothache indication 27355003
Tendinitis indication 34840004 DOID:971
Migraine indication 37796009 DOID:6364
Joint pain indication 57676002
Nasal discharge indication 64531003
Muscle pain indication 68962001
Rheumatoid arthritis indication 69896004 DOID:7148
Bursitis indication 84017003 DOID:2965
Gout indication 90560007 DOID:13189
Headache disorder indication 230461009
Dysmenorrhea indication 266599000
Fever indication 386661006
Osteoarthritis indication 396275006
Juvenile rheumatoid arthritis indication 410795001
Tachyarrhythmia contraindication 6285003
Alcoholism contraindication 7200002
Hypercholesterolemia contraindication 13644009
Myocardial infarction contraindication 22298006 DOID:5844
Hypovolemia contraindication 28560003
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Body fluid retention contraindication 43498006
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Gastrointestinal perforation contraindication 51875005
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Hemiplegic migraine contraindication 59292006
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Osteoporosis contraindication 64859006 DOID:11476
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Vascular insufficiency of intestine contraindication 82196007
Atrophic gastritis contraindication 84568007 DOID:8929
Epilepsy contraindication 84757009 DOID:1826
Prinzmetal angina contraindication 87343002
Kidney disease contraindication 90708001 DOID:557
Fracture of bone contraindication 125605004
Liver function tests abnormal contraindication 166603001
Hypomagnesemia contraindication 190855004
Angina pectoris contraindication 194828000
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Transient ischemic attack contraindication 266257000 DOID:224
Esophageal dysmotility contraindication 266434009 DOID:9192
Benign prostatic hyperplasia contraindication 266569009
Edema contraindication 267038008
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Cerebral ischemia contraindication 287731003
Pregnancy, function contraindication 289908002
Thromboembolic disorder contraindication 371039008
Serotonin syndrome contraindication 371089000
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Peripheral vascular disease contraindication 400047006
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Obesity contraindication 414916001 DOID:9970
Hypertensive urgency contraindication 443482000
Smokes tobacco daily contraindication 449868002




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Horses Myositis Indication
Horses Pain and inflammation associated with arthritis Indication
Horses Soft tissue diseases of the musculoskeletal system Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Equiproxen Granules Zoetis Inc. 1
Equiproxen 10% Solution Zoetis Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.36 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8852636 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8858996 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9161920 May 31, 2022 RISK-REDUCTION OF NSAID GASTRIC ULCER IN PATIENTS REQUIRING CHRONIC NSAID TREATMENT
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9198888 May 31, 2022 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8852636 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8858996 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9161920 May 31, 2022 RISK-REDUCTION OF NSAID GASTRIC ULCER IN PATIENTS REQUIRING CHRONIC NSAID TREATMENT
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9198888 May 31, 2022 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
500MG;EQ 85MG BASE TREXIMET CURRAX N021926 April 15, 2008 RX TABLET ORAL 7332183 Oct. 2, 2025 TREATMENT OF MIGRAINE
60MG;EQ 10MG BASE TREXIMET CURRAX N021926 May 14, 2015 DISCN TABLET ORAL 7332183 Oct. 2, 2025 ACUTE TREATMENT OF MIGRAINE
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10022344 March 3, 2026 TEMPORARY REDUCTION OF FEVER
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10022344 March 3, 2026 TEMPORARY RELIEF OF MINOR ACHES AND PAINS
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10028925 March 3, 2026 TEMPORARY REDUCTION OF FEVER
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10028925 March 3, 2026 TEMPORARY RELIEF OF MINOR ACHES AND PAINS
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 11090280 March 3, 2026 TEMPORARY REDUCTION OF FEVER
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 11090280 March 3, 2026 TEMPORARY RELIEF OF MINOR ACHES AND PAINS
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9393208 Sept. 3, 2029 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9393208 Sept. 3, 2029 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9220698 March 10, 2031 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8945621 Oct. 17, 2031 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS ALSO TAKING LOW DOSE ASPIRIN
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8945621 Oct. 17, 2031 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS ALSO TAKING LOW DOSE ASPIRIN

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 5.60 CHEMBL CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR IC50 5.16 WOMBAT-PK CHEMBL
Aldo-keto reductase family 1 member C2 Enzyme IC50 4.50 CHEMBL
Aldo-keto reductase family 1 member C3 Enzyme IC50 6.32 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 6.74 CHEMBL
Prostaglandin-H2 D-isomerase Enzyme IC50 4.89 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 5.47 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 4.96 CHEMBL
Hormone-sensitive lipase Enzyme IC50 5.92 CHEMBL
Cyclooxygenase Enzyme IC50 7.22 CHEMBL

External reference:

IDSource
4018847 VUID
N0000147149 NUI
D00118 KEGG_DRUG
26159-34-2 SECONDARY_CAS_RN
4018846 VANDF
4018847 VANDF
C0027396 UMLSCUI
CHEBI:59527 CHEBI
NPS PDB_CHEM_ID
CHEMBL154 ChEMBL_ID
DB00788 DRUGBANK_ID
CHEMBL1200806 ChEMBL_ID
D009288 MESH_DESCRIPTOR_UI
156391 PUBCHEM_CID
2979 INN_ID
5230 IUPHAR_LIGAND_ID
57Y76R9ATQ UNII
142442 RXNORM
2108 MMSL
2111 MMSL
5155 MMSL
5156 MMSL
6350 MMSL
8137 MMSL
d00019 MMSL
002380 NDDF
002381 NDDF
11847009 SNOMEDCT_US
372588000 SNOMEDCT_US
42692007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Naproxen HUMAN PRESCRIPTION DRUG LABEL 1 0054-3630 SUSPENSION 125 mg ORAL ANDA 28 sections
Naproxen HUMAN PRESCRIPTION DRUG LABEL 1 0054-3630 SUSPENSION 125 mg ORAL ANDA 28 sections
Naproxen HUMAN PRESCRIPTION DRUG LABEL 1 0093-1005 TABLET, DELAYED RELEASE 375 mg ORAL ANDA 28 sections
Naproxen HUMAN PRESCRIPTION DRUG LABEL 1 0093-1006 TABLET, DELAYED RELEASE 500 mg ORAL ANDA 28 sections
Good Sense Naproxen Sodium HUMAN OTC DRUG LABEL 1 0113-0901 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
good sense naproxen sodium HUMAN OTC DRUG LABEL 1 0113-1412 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
good sense naproxen sodium HUMAN OTC DRUG LABEL 1 0113-1773 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
Good Sense Naproxen Sodium HUMAN OTC DRUG LABEL 1 0113-4368 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
basic care naproxen sodium HUMAN OTC DRUG LABEL 1 0113-7033 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
basic care naproxen sodium pm HUMAN OTC DRUG LABEL 2 0113-7264 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
Basic Care Naproxen Sodium HUMAN OTC DRUG LABEL 1 0113-7368 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
basic care naproxen sodium HUMAN OTC DRUG LABEL 1 0113-7901 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
good sense naproxen sodium HUMAN OTC DRUG LABEL 2 0113-8264 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
good sense naproxen sodium HUMAN OTC DRUG LABEL 2 0113-8264 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
Naprosyn HUMAN PRESCRIPTION DRUG LABEL 1 0121-0899 SUSPENSION 125 mg ORAL NDA 29 sections
Naprosyn HUMAN PRESCRIPTION DRUG LABEL 1 0121-1798 SUSPENSION 250 mg ORAL NDA 29 sections
Naprosyn HUMAN PRESCRIPTION DRUG LABEL 1 0121-2697 SUSPENSION 500 mg ORAL NDA 29 sections
Aleve Headache Pain HUMAN OTC DRUG LABEL 1 0280-0041 TABLET 220 mg ORAL NDA 17 sections
Menstridol HUMAN OTC DRUG LABEL 1 0280-0270 TABLET 220 mg ORAL NDA 17 sections
Aleve PM HUMAN OTC DRUG LABEL 2 0280-1200 TABLET, FILM COATED 220 mg ORAL NDA 17 sections
AleveCaplets HUMAN OTC DRUG LABEL 1 0280-6000 TABLET 220 mg ORAL NDA 17 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6010 TABLET 220 mg ORAL NDA 17 sections
AleveGelcaps HUMAN OTC DRUG LABEL 1 0280-6020 TABLET, COATED 220 mg ORAL NDA 16 sections
Aleve-D Sinus and Headache HUMAN OTC DRUG LABEL 2 0280-6045 TABLET 220 mg ORAL ANDA 17 sections
AleveCaplets - Easy Open Arthritis Cap HUMAN OTC DRUG LABEL 1 0280-6050 TABLET 220 mg ORAL NDA 16 sections
AleveEasy Open Arthritis Cap HUMAN OTC DRUG LABEL 1 0280-6060 TABLET 220 mg ORAL NDA 17 sections
AleveGelcaps HUMAN OTC DRUG LABEL 1 0280-6070 TABLET, COATED 220 mg ORAL NDA 17 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6080 CAPSULE, LIQUID FILLED 220 mg ORAL NDA 17 sections
Aleve-D Sinus and Cold HUMAN OTC DRUG LABEL 2 0280-6090 TABLET 220 mg ORAL ANDA 17 sections
AleveEasy Open Arthritis Cap HUMAN OTC DRUG LABEL 1 0280-6091 CAPSULE, LIQUID FILLED 220 mg ORAL NDA 17 sections