ibuprofen 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
anti-inflammatory agents, ibuprofen derivatives 1407 15687-27-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ibuprofen lysine
  • ibuprofen lysinate
  • ibuprofen lysine salt
  • soluphene
  • solufenum
  • neoprofen
  • ibuprofen
  • ibuprofen sodium
A nonsteroidal anti-inflammatory agent with analgesic properties used in the treatment of RHEUMATISM and ARTHRITIS. Concerns that anti-inflammatory drugs such as ibuprofen may worsen COVID-19 circulated widely in the early months of the pandemic. FDA has stated that it is not aware of scientific evidence connecting the use of NSAIAs, such as ibuprofen, with worsening COVID-19 symptoms and will communicate publicly when more information is available.
  • Molecular weight: 206.29
  • Formula: C13H18O2
  • CLOGP: 3.68
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 37.30
  • ALOGS: -3.48
  • ROTB: 4
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
30 mg P
1.20 g O
1.20 g P
1.20 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.04 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) 193.90 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 85 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.15 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.82 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.60 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Sept. 19, 1974 FDA
Jan. 19, 2018 PMDA Senju Pharmaceutical Co., Ltd.

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
Intentional overdose 1007.13 9.88 1690 380867 72462 63034003
Muscle injury 615.54 9.88 1273 381284 64072 63042393
Irritable bowel syndrome 588.72 9.88 1438 381119 80974 63025491
Folliculitis 583.25 9.88 1301 381256 69016 63037449
Cholecystitis chronic 509.38 9.88 454 382103 9907 63096558
Injury 498.75 9.88 1255 381302 71992 63034473
Angioedema 483.24 9.88 961 381596 47004 63059461
Lower respiratory tract infection 463.66 9.88 1799 380758 130508 62975957
Blister 458.90 9.88 1770 380787 128044 62978421
Sleep disorder due to general medical condition, insomnia type 430.55 9.88 964 381593 51253 63055212
Death 422.71 9.88 1027 381530 373354 62733111
Impaired healing 417.72 9.88 1464 381093 101078 63005387
Off label use 392.00 9.88 2422 380135 672040 62434425
Suicide attempt 364.80 9.88 995 381562 59923 63046542
Pneumonia 343.89 9.88 1500 381057 455267 62651198
Gastrointestinal disorder 337.80 9.88 1626 380931 129613 62976852
Abdominal pain upper 318.08 9.88 2232 380325 204212 62902253
Urticaria 305.48 9.88 1875 380682 163927 62942538
Ill-defined disorder 293.87 9.88 1121 381436 80634 63025831
Pruritus 287.55 9.88 3385 379172 358068 62748397
Sinusitis 275.72 9.88 2319 380238 224334 62882131
Emotional distress 269.49 9.88 602 381955 31947 63074518
Duodenal ulcer perforation 268.87 9.88 1140 381417 86069 63020396
Stomatitis 266.41 9.88 1586 380971 137139 62969326
Muscle spasticity 233.21 9.88 448 382109 21346 63085119
Drug hypersensitivity 226.64 9.88 2863 379694 307824 62798641
Helicobacter infection 222.55 9.88 1127 381430 91658 63014807
Ear pain 214.24 9.88 588 381969 35530 63070935
Tubulointerstitial nephritis 210.36 9.88 407 382150 19496 63086969
Uterine perforation 208.46 9.88 233 382324 6730 63099735
Peripheral swelling 205.22 9.88 2477 380080 263465 62843000
Aspirin-exacerbated respiratory disease 203.27 9.88 102 382455 793 63105672
Oligohydramnios 202.66 9.88 220 382337 6146 63100319
Febrile neutropenia 198.61 9.88 253 382304 118196 62988269
Overdose 186.36 9.88 1260 381297 113818 62992647
Deafness transitory 185.90 9.88 127 382430 1843 63104622
Renal tubular acidosis 181.16 9.88 118 382439 1574 63104891
Lip oedema 179.24 9.88 165 382392 3759 63102706
Cardiac failure 172.89 9.88 169 382388 88973 63017492
Fall 167.50 9.88 1534 381023 390800 62715665
Interstitial lung disease 163.91 9.88 84 382473 61824 63044641
Night sweats 162.10 9.88 653 381904 48161 63058304
Infection 160.22 9.88 2096 380461 227077 62879388
Cardiac failure congestive 156.43 9.88 196 382361 92237 63014228
Nasopharyngitis 154.48 9.88 2268 380289 251989 62854476
Gallbladder disorder 154.28 9.88 347 382210 18495 63087970
Neutropenia 146.84 9.88 550 382007 174455 62932010
Malignant neoplasm progression 144.41 9.88 169 382388 81952 63024513
Biliary dyskinesia 138.96 9.88 122 382435 2607 63103858
Body temperature increased 138.56 9.88 516 382041 36676 63069789
Haematemesis 138.52 9.88 451 382106 29961 63076504
Joint swelling 138.38 9.88 2756 379801 324910 62781555
Intentional self-injury 133.70 9.88 399 382158 25288 63081177
Disease progression 130.24 9.88 347 382210 122411 62984054
Deep vein thrombosis 129.38 9.88 907 381650 82893 63023572
Hypersensitivity 127.66 9.88 2474 380083 290211 62816254
Respiratory disorder 127.52 9.88 520 382037 38562 63067903
Gastrointestinal pain 124.90 9.88 217 382340 9559 63096906
Drug ineffective 123.54 9.88 5099 377458 1039666 62066799
Therapeutic product effect decreased 122.72 9.88 1737 380820 191450 62915015
Completed suicide 121.13 9.88 1377 381180 144296 62962169
Toxicity to various agents 118.55 9.88 2121 380436 245129 62861336
Sepsis 113.52 9.88 505 382052 152618 62953847
Confusional state 113.40 9.88 2028 380529 234352 62872113
Stevens-Johnson syndrome 112.73 9.88 369 382188 24581 63081884
Metabolic acidosis 111.94 9.88 553 382004 44516 63061949
Platelet count decreased 111.62 9.88 344 382213 115778 62990687
Gastric ulcer 109.06 9.88 356 382201 23681 63082784
Anaemia 108.15 9.88 1188 381369 292242 62814223
Thrombocytopenia 104.10 9.88 512 382045 150645 62955820
Atrial fibrillation 101.46 9.88 361 382196 116275 62990190
Hospitalisation 97.61 9.88 231 382326 84850 63021615
Toxic epidermal necrolysis 94.79 9.88 352 382205 24982 63081483
Weight increased 93.67 9.88 2143 380414 258649 62847816
Cholelithiasis 92.58 9.88 515 382042 43410 63063055
Drug resistance 92.15 9.88 14 382543 22919 63083546
Sleep disorder 91.88 9.88 821 381736 80745 63025720
Gastric ulcer perforation 87.64 9.88 67 382490 1169 63105296
Macular degeneration 87.02 9.88 20 382537 24356 63082109
Eyelid oedema 86.92 9.88 194 382363 10285 63096180
Hypervolaemia 82.27 9.88 34 382523 28379 63078086
Pericarditis 82.26 9.88 1180 381377 130399 62976066
Meningitis aseptic 82.10 9.88 122 382435 4701 63101764
Peritonsillar abscess 81.64 9.88 48 382509 527 63105938
Fixed eruption 80.13 9.88 62 382495 1102 63105363
Fluid retention 79.41 9.88 149 382408 59537 63046928
Pain 78.50 9.88 5320 377237 735308 62371157
Diarrhoea 78.20 9.88 3520 379037 711846 62394619
Orthostatic hypotension 77.99 9.88 62 382495 36098 63070367
Discomfort 76.70 9.88 1426 381131 165948 62940517
Acute kidney injury 76.60 9.88 2104 380453 261311 62845154
Upper gastrointestinal haemorrhage 76.53 9.88 269 382288 18583 63087882
Renal impairment 76.47 9.88 274 382283 88081 63018384
Duodenal ulcer 76.39 9.88 154 382403 7602 63098863
Urinary tract infection 76.13 9.88 1129 381428 263555 62842910
Contusion 76.08 9.88 1299 381258 148745 62957720
Kounis syndrome 75.65 9.88 71 382486 1659 63104806
Myocardial infarction 74.28 9.88 329 382228 99564 63006901
Face oedema 74.09 9.88 279 382278 19933 63086532
Anhedonia 73.54 9.88 187 382370 10787 63095678
Anti-cyclic citrullinated peptide antibody positive 73.36 9.88 1044 381513 115168 62991297
Swelling 73.27 9.88 2175 380382 273203 62833262
Plasma cell myeloma 73.22 9.88 65 382492 35840 63070625
Haemoglobin decreased 72.74 9.88 545 382012 144940 62961525
Femur fracture 72.25 9.88 87 382470 41669 63064796
Chronic obstructive pulmonary disease 72.06 9.88 170 382387 62516 63043949
Vomiting 71.82 9.88 4088 378469 555529 62550936
Pharyngitis 71.33 9.88 275 382282 19868 63086597
Gallbladder injury 71.22 9.88 63 382494 1360 63105105
Cytomegalovirus infection 69.41 9.88 20 382537 20932 63085533
Wound closure 68.72 9.88 26 382531 90 63106375
Pancytopenia 68.06 9.88 326 382231 96607 63009858
Neuropathy peripheral 67.75 9.88 404 382153 113263 62993202
Malaise 67.06 9.88 1951 380606 414003 62692462
Analgesic drug level increased 66.97 9.88 77 382480 2295 63104170
Enthesopathy 66.49 9.88 155 382402 8459 63098006
White blood cell count decreased 65.84 9.88 529 382028 138575 62967890
Red blood cell sedimentation rate abnormal 65.32 9.88 19 382538 19763 63086702
Treatment failure 65.11 9.88 827 381730 198216 62908249
Myelosuppression 64.48 9.88 31 382526 23672 63082793
Cardiac disorder 63.17 9.88 132 382425 50684 63055781
Herpes zoster 62.88 9.88 269 382288 82193 63024272
Clostridium difficile infection 62.43 9.88 53 382504 29869 63076596
Bezoar 61.74 9.88 60 382497 1466 63104999
Neutrophil count decreased 61.66 9.88 157 382400 56249 63050216
Septic shock 61.47 9.88 201 382356 66428 63040037
Pleural effusion 61.14 9.88 321 382236 92889 63013576
Hypoaldosteronism 59.89 9.88 27 382530 160 63106305
Hypomagnesaemia 59.84 9.88 51 382506 28686 63077779
Pulmonary embolism 59.79 9.88 1012 381545 115672 62990793
Wrong technique in product usage process 59.65 9.88 185 382372 62155 63044310
Osteoporosis 59.34 9.88 164 382393 57174 63049291
Vanishing bile duct syndrome 59.33 9.88 43 382514 689 63105776
Melaena 58.73 9.88 348 382209 30017 63076448
Dehydration 58.67 9.88 715 381842 172639 62933826
Ductus arteriosus premature closure 58.36 9.88 32 382525 304 63106161
Gastritis 58.28 9.88 405 382152 36898 63069567
Blood pressure increased 57.70 9.88 661 381896 161401 62945064
Pulmonary arterial hypertension 56.31 9.88 33 382524 22544 63083921
Anxiety 55.35 9.88 1709 380848 215832 62890633
Rash 54.95 9.88 4004 378553 556867 62549598
Product prescribing error 54.57 9.88 307 382250 25982 63080483
Hyponatraemia 54.12 9.88 423 382134 111477 62994988
Bone marrow failure 53.96 9.88 58 382499 29232 63077233
Cough 53.92 9.88 1347 381210 291396 62815069
Lip swelling 53.79 9.88 346 382211 30717 63075748
Osteotomy 53.69 9.88 27 382530 211 63106254
Foreign body in throat 53.41 9.88 30 382527 300 63106165
Transplant rejection 52.74 9.88 3 382554 10777 63095688
Bronchitis 51.63 9.88 492 382065 124443 62982022
Leukopenia 50.79 9.88 266 382291 77024 63029441
Biliary colic 49.79 9.88 83 382474 3534 63102931
Dyspnoea exertional 49.56 9.88 191 382366 60111 63046354
Pulmonary hypertension 49.09 9.88 93 382464 37030 63069435
Acute myeloid leukaemia 48.87 9.88 21 382536 17126 63089339
Bradycardia 48.69 9.88 251 382306 72976 63033489
Pneumocystis jirovecii pneumonia 47.75 9.88 21 382536 16893 63089572
Ductus arteriosus stenosis foetal 47.73 9.88 23 382534 162 63106303
Arthralgia 47.24 9.88 4015 378542 565695 62540770
Self-medication 47.18 9.88 70 382487 2693 63103772
Gastrointestinal haemorrhage 47.18 9.88 719 381838 80457 63026008
Gallbladder cholesterolosis 47.10 9.88 39 382518 767 63105698
Respiratory failure 46.97 9.88 390 382167 101468 63004997
Hypocalcaemia 46.91 9.88 74 382483 31639 63074826
Oesophageal obstruction 46.74 9.88 34 382523 548 63105917
Oxygen saturation decreased 46.11 9.88 328 382229 88257 63018208
Ankylosing spondylitis 45.61 9.88 153 382404 10321 63096144
Shoulder arthroplasty 44.95 9.88 84 382473 3918 63102547
Dementia 44.75 9.88 29 382528 18765 63087700
Productive cough 44.70 9.88 212 382345 62996 63043469
Neonatal cardiac failure 44.58 9.88 12 382545 6 63106459
Multiple organ dysfunction syndrome 44.58 9.88 183 382374 56569 63049896
Tenosynovitis 44.55 9.88 183 382374 13612 63092853
Insomnia 44.11 9.88 1649 380908 213603 62892862
Myelodysplastic syndrome 43.94 9.88 23 382534 16731 63089734
Rheumatoid arthritis 43.60 9.88 1908 380649 251911 62854554
Pulmonary infarction 43.23 9.88 67 382490 2680 63103785
Transfusion 42.79 9.88 19 382538 15198 63091267
Systemic lupus erythematosus rash 42.76 9.88 60 382497 2192 63104273
Pneumonia aspiration 42.69 9.88 90 382467 34450 63072015
Product use issue 42.68 9.88 1007 381550 219513 62886952
Acute lung injury 42.68 9.88 50 382507 1521 63104944
Bronchiectasis 42.57 9.88 22 382535 16120 63090345
Constipation 42.49 9.88 1031 381526 223912 62882553
Functional gastrointestinal disorder 42.46 9.88 85 382472 4174 63102291
Device related infection 42.34 9.88 47 382510 23345 63083120
Frequent bowel movements 41.96 9.88 46 382511 22976 63083489
Medication error 41.52 9.88 490 382067 51794 63054671
Tongue disorder 41.26 9.88 149 382408 10431 63096034
Jejunal ulcer 41.17 9.88 18 382539 98 63106367
Premature delivery 40.80 9.88 75 382482 30206 63076259
Neurotoxicity 40.75 9.88 26 382531 16964 63089501
Duodenal ulcer haemorrhage 39.99 9.88 61 382496 2406 63104059
Medication overuse headache 39.99 9.88 36 382521 796 63105669
Hypotension 39.85 9.88 1295 381262 271309 62835156
Hip fracture 39.71 9.88 73 382484 29401 63077064
General physical health deterioration 39.61 9.88 1536 381021 199866 62906599
Serotonin syndrome 39.57 9.88 70 382487 28612 63077853
Sedation 39.42 9.88 112 382445 38697 63067768
Oedema peripheral 39.33 9.88 856 381701 188655 62917810
Sedation complication 39.28 9.88 17 382540 13805 63092660
Abdominal pain lower 39.06 9.88 277 382280 25401 63081064
Creatinine renal clearance decreased 39.05 9.88 25 382532 16283 63090182
Right ventricular failure 38.95 9.88 28 382529 17160 63089305
Full blood count abnormal 38.90 9.88 83 382474 31634 63074831
Ascites 38.87 9.88 121 382436 40607 63065858
Lemierre syndrome 38.82 9.88 17 382540 93 63106372
Diabetes mellitus 38.41 9.88 189 382368 55621 63050844
Tendonitis 38.06 9.88 225 382332 19390 63087075
Heavy menstrual bleeding 37.85 9.88 209 382348 17564 63088901
Embedded device 37.75 9.88 72 382485 3411 63103054
Foetal acidosis 37.74 9.88 11 382546 11 63106454
Mucosal inflammation 37.69 9.88 150 382407 46778 63059687
Loss of personal independence in daily activities 37.33 9.88 390 382167 96900 63009565
Gastric perforation 36.85 9.88 48 382509 1631 63104834
Cytopenia 36.76 9.88 12 382545 11589 63094876
Toxic shock syndrome streptococcal 36.48 9.88 17 382540 110 63106355
Musculoskeletal disorder 36.39 9.88 231 382326 20413 63086052
Cerebrovascular accident 36.35 9.88 446 382111 107578 62998887
Intestinal obstruction 36.14 9.88 83 382474 30816 63075649
Red blood cell sedimentation rate 36.01 9.88 86 382471 4768 63101697
Medical device discomfort 35.84 9.88 51 382506 1888 63104577
Foot operation 35.45 9.88 110 382447 7121 63099344
Cholesterosis 35.23 9.88 26 382531 429 63106036
Product dose omission issue 35.22 9.88 1109 381448 233204 62873261
Cataract 34.93 9.88 201 382356 56852 63049613
Musculoskeletal stiffness 34.67 9.88 1401 381156 183217 62923248
Posterior reversible encephalopathy syndrome 34.65 9.88 32 382525 17313 63089152
Cholecystitis acute 34.51 9.88 119 382438 8141 63098324
Gastritis erosive 34.50 9.88 97 382460 5942 63100523
Pain in jaw 34.32 9.88 140 382417 43356 63063109
Acute generalised exanthematous pustulosis 34.10 9.88 145 382412 10954 63095511
Tongue oedema 33.75 9.88 81 382476 4505 63101960
Psoriatic arthropathy 33.70 9.88 755 381802 90765 63015700
Blood glucose increased 33.68 9.88 332 382225 83424 63023041
Pharyngeal abscess 33.43 9.88 21 382536 262 63106203
Acute hepatic failure 32.88 9.88 206 382351 18121 63088344
Bone erosion 32.73 9.88 35 382522 17682 63088783
Adjustment disorder with depressed mood 32.67 9.88 135 382422 10069 63096396
Unevaluable event 32.56 9.88 179 382378 51207 63055258
Balance disorder 32.56 9.88 338 382219 84084 63022381
Glomerulonephritis membranous 32.53 9.88 28 382529 582 63105883
Device expulsion 32.45 9.88 105 382452 34817 63071648
Open globe injury 32.29 9.88 12 382545 39 63106426
Ear infection 32.07 9.88 362 382195 37851 63068614
Obstructive airways disorder 31.86 9.88 47 382510 20652 63085813
Pelvic pain 31.53 9.88 163 382394 13356 63093109
Palatal oedema 31.50 9.88 27 382530 558 63105907
Periorbital oedema 31.21 9.88 90 382467 5594 63100871
Bronchopulmonary aspergillosis 30.99 9.88 7 382550 8628 63097837
Inappropriate schedule of product administration 30.69 9.88 441 382116 103524 63002941
C-reactive protein abnormal 30.64 9.88 418 382139 45678 63060787
Hepatitis cholestatic 30.42 9.88 101 382456 6777 63099688
Perichondritis 30.39 9.88 12 382545 48 63106417
Hunger 30.34 9.88 86 382471 5293 63101172
Cytokine release syndrome 30.30 9.88 25 382532 14289 63092176
Rheumatoid nodule 30.26 9.88 192 382365 16963 63089502
Metastases to bone 30.19 9.88 50 382507 20969 63085496
Hypoglycaemia 30.00 9.88 225 382332 59840 63046625
Injection site pain 29.98 9.88 576 381981 129224 62977241
Gallbladder hypofunction 29.75 9.88 26 382531 552 63105913
Foreign body in gastrointestinal tract 29.54 9.88 11 382546 36 63106429
Multiple sclerosis 29.34 9.88 249 382308 24123 63082342
Eosinophilic oesophagitis 29.32 9.88 21 382536 330 63106135
Pelvic venous thrombosis 29.31 9.88 44 382513 1711 63104754
Tumour lysis syndrome 29.02 9.88 9 382548 8981 63097484
Renal papillary necrosis 28.94 9.88 19 382538 257 63106208
Metastases to liver 28.88 9.88 62 382495 23577 63082888
Torsade de pointes 28.65 9.88 23 382534 13328 63093137
Gastrointestinal toxicity 28.49 9.88 107 382450 7634 63098831
Thrombotic microangiopathy 28.44 9.88 14 382543 10547 63095918
Hepatic function abnormal 28.40 9.88 121 382436 37021 63069444
Nasal disorder 28.36 9.88 57 382500 2807 63103658
Necrotising fasciitis 28.32 9.88 59 382498 2982 63103483
Cardiac failure acute 28.21 9.88 11 382546 9512 63096953
Hypertension 28.20 9.88 1385 381172 277918 62828547
Breast cancer stage I 28.15 9.88 4 382553 6885 63099580
Laryngeal oedema 28.04 9.88 87 382470 5631 63100834
Full blood count decreased 28.01 9.88 73 382484 25951 63080514
Duodenitis haemorrhagic 27.96 9.88 8 382549 7 63106458
Lung neoplasm malignant 27.92 9.88 47 382510 19586 63086879
Suspected suicide 27.77 9.88 95 382462 6473 63099992
Exposure during pregnancy 27.72 9.88 719 381838 154828 62951637
Therapeutic product effect incomplete 27.65 9.88 559 381998 124497 62981968
Pneumonia viral 27.30 9.88 7 382550 7915 63098550
Drug level decreased 27.28 9.88 7 382550 7912 63098553
Dyskinesia 27.18 9.88 100 382457 31902 63074563
Brain death 27.02 9.88 62 382495 3348 63103117
Aorto-oesophageal fistula 26.96 9.88 9 382548 19 63106446
Thyroid disorder 26.86 9.88 31 382526 15131 63091334
Pericardial effusion 26.81 9.88 92 382465 29966 63076499
Lip dry 26.59 9.88 172 382385 15298 63091167
Electrocardiogram QT prolonged 26.51 9.88 230 382327 59300 63047165
Hyperglycaemia 26.44 9.88 146 382411 41721 63064744
Blood pressure systolic increased 26.39 9.88 172 382385 47225 63059240
Brain empyema 26.35 9.88 7 382550 3 63106462
Heart rate decreased 26.05 9.88 164 382393 45396 63061069
Extrapyramidal disorder 25.96 9.88 25 382532 13259 63093206
Poisoning 25.84 9.88 156 382401 13544 63092921
Immunodeficiency 25.69 9.88 52 382505 20202 63086263
Pathogen resistance 25.49 9.88 4 382553 6394 63100071
Glaucoma 25.31 9.88 47 382510 18858 63087607
Corneal leukoma 25.30 9.88 8 382549 13 63106452
Red blood cell count decreased 24.98 9.88 143 382414 40502 63065963
Protein-losing gastroenteropathy 24.85 9.88 16 382541 209 63106256
Epilepsy 24.71 9.88 82 382475 26983 63079482
Genital odour 24.71 9.88 6 382551 0 63106465
Tonsillar erythema 24.71 9.88 6 382551 0 63106465
Aspergillus infection 24.56 9.88 9 382548 8084 63098381
Oral candidiasis 24.50 9.88 64 382493 22734 63083731
Blood magnesium decreased 24.46 9.88 26 382531 13172 63093293
Dislocation of vertebra 24.39 9.88 110 382447 8525 63097940
Staphylococcal infection 24.37 9.88 147 382410 41109 63065356
Condition aggravated 24.24 9.88 2090 380467 400127 62706338
Drug interaction 24.15 9.88 1131 381426 228000 62878465
Flushing 24.14 9.88 313 382244 74774 63031691
Temperature regulation disorder 24.06 9.88 4 382553 6128 63100337
Diabetic ketoacidosis 24.05 9.88 55 382502 20450 63086015
Infected dermal cyst 24.02 9.88 21 382536 446 63106019
Unintentional medical device removal 23.97 9.88 4 382553 6111 63100354
Second primary malignancy 23.87 9.88 9 382548 7944 63098521
Underdose 23.84 9.88 85 382472 27371 63079094
Hepatic enzyme increased 23.72 9.88 1467 381090 200861 62905604
Autoimmune disorder 23.67 9.88 181 382376 16996 63089469
Parkinsonism 23.66 9.88 17 382540 10422 63096043
Progressive multifocal leukoencephalopathy 23.55 9.88 26 382531 12945 63093520
Cardiotoxicity 23.01 9.88 11 382546 8427 63098038
Blood pressure fluctuation 22.89 9.88 174 382383 46143 63060322
Respiratory tract infection 22.87 9.88 151 382406 41332 63065133
Therapy interrupted 22.86 9.88 109 382448 32346 63074119
Coeliac disease 22.85 9.88 26 382531 12771 63093694
Medical device pain 22.75 9.88 37 382520 1543 63104922
Chondritis 22.67 9.88 7 382550 10 63106455
Cystitis 22.52 9.88 217 382340 54774 63051691
Distichiasis 22.50 9.88 8 382549 22 63106443
Serum sickness-like reaction 22.43 9.88 21 382536 489 63105976
Cellulitis 22.35 9.88 353 382204 81605 63024860
Ventricular tachycardia 22.31 9.88 55 382502 19924 63086541
Pulmonary oedema 22.27 9.88 217 382340 54656 63051809
Anti-cyclic citrullinated peptide antibody 22.10 9.88 90 382467 6668 63099797
Blood pressure decreased 22.04 9.88 268 382289 64754 63041711
Breast cancer 21.96 9.88 186 382371 48197 63058268
Osteonecrosis of jaw 21.90 9.88 123 382434 35000 63071465
Cushingoid 21.74 9.88 12 382545 8473 63097992
Cholecystitis 21.74 9.88 163 382394 15214 63091251
Hyperkalaemia 21.73 9.88 215 382342 53988 63052477
Laryngeal discomfort 21.70 9.88 17 382540 308 63106157
Acute pulmonary oedema 21.69 9.88 11 382546 8147 63098318
Deformity 21.68 9.88 23 382534 11661 63094804
Cerebral venous sinus thrombosis 21.66 9.88 41 382516 1931 63104534
Embolism arterial 21.62 9.88 28 382529 946 63105519
Blood calcium decreased 21.59 9.88 84 382473 26367 63080098
Facet joint syndrome 21.51 9.88 136 382421 12002 63094463
Psychological trauma 21.48 9.88 30 382527 1091 63105374
Influenza 21.42 9.88 495 382062 108227 62998238
Neoplasm progression 21.41 9.88 130 382427 36298 63070167
Diffuse large B-cell lymphoma 21.17 9.88 7 382550 6705 63099760
Deep vein thrombosis postoperative 21.16 9.88 129 382428 11240 63095225
Multiple sclerosis relapse 21.13 9.88 410 382147 48068 63058397
Type IV hypersensitivity reaction 21.13 9.88 51 382506 2847 63103618
Breath sounds abnormal 21.04 9.88 21 382536 10952 63095513
Abdominal pain 21.00 9.88 2047 380510 291409 62815056
Kidney enlargement 20.97 9.88 23 382534 650 63105815
Blood creatine phosphokinase increased 20.97 9.88 103 382454 30327 63076138
Muscle rigidity 20.93 9.88 23 382534 11477 63094988
Infertility female 20.80 9.88 21 382536 538 63105927
Psychotic disorder 20.76 9.88 82 382475 25630 63080835
Myoclonus 20.76 9.88 40 382517 15828 63090637
Internal injury 20.76 9.88 17 382540 329 63106136
Stress cardiomyopathy 20.63 9.88 16 382541 9434 63097031
Osteonecrosis 20.60 9.88 77 382480 24453 63082012
Viral parotitis 20.59 9.88 5 382552 0 63106465
Grip strength decreased 20.48 9.88 215 382342 22072 63084393
Poor venous access 20.47 9.88 36 382521 14749 63091716
Hepatic necrosis 20.43 9.88 78 382479 5609 63100856
Pneumonia streptococcal 20.33 9.88 38 382519 1773 63104692
Schizophrenia 20.31 9.88 18 382539 9934 63096531
Synovitis 20.22 9.88 1346 381211 185572 62920893
Mania 20.11 9.88 27 382530 12340 63094125
Hypoxia 20.06 9.88 247 382310 59545 63046920
Enzyme induction 20.01 9.88 9 382548 53 63106412
Dysmenorrhoea 20.00 9.88 61 382496 3912 63102553
Bacteraemia 19.97 9.88 47 382510 17301 63089164
Urosepsis 19.90 9.88 52 382505 18472 63087993
Diabetes mellitus inadequate control 19.90 9.88 38 382519 15088 63091377
Hepatic cirrhosis 19.90 9.88 79 382478 24655 63081810
Renal failure 19.86 9.88 548 382009 117104 62989361
Breast cancer female 19.71 9.88 32 382525 13527 63092938
Genital tract inflammation 19.70 9.88 8 382549 35 63106430
Myopathy 19.70 9.88 23 382534 11168 63095297
Beta haemolytic streptococcal infection 19.70 9.88 40 382517 1985 63104480
Ceruloplasmin decreased 19.67 9.88 6 382551 8 63106457
Spinal compression fracture 19.58 9.88 35 382522 14248 63092217
Necrosis ischaemic 19.53 9.88 25 382532 835 63105630
Blood parathyroid hormone decreased 19.44 9.88 113 382444 9678 63096787
Rales 19.38 9.88 29 382528 12668 63093797
Hypertensive emergency 19.29 9.88 38 382519 1844 63104621
Device malfunction 19.28 9.88 50 382507 17807 63088658
Posthaemorrhagic hydrocephalus 19.25 9.88 7 382550 21 63106444
Acute myocardial infarction 19.22 9.88 114 382443 32010 63074455
Gastric ulcer haemorrhage 19.03 9.88 69 382488 4839 63101626
Genital haemorrhage 18.94 9.88 91 382466 7241 63099224
Fear 18.94 9.88 161 382396 15605 63090860
Product use in unapproved indication 18.85 9.88 884 381673 178196 62928269
Oligoarthritis 18.64 9.88 20 382537 551 63105914
Blood potassium increased 18.47 9.88 53 382504 18256 63088209
Electrocardiogram U-wave abnormality 18.34 9.88 7 382550 25 63106440
Disease recurrence 18.11 9.88 97 382460 27933 63078532
Blood glucose decreased 18.10 9.88 65 382492 20887 63085578
Injection site extravasation 18.03 9.88 16 382541 8825 63097640
Headache 17.98 9.88 4190 378367 629051 62477414
Haematotoxicity 17.91 9.88 18 382539 9358 63097107
Febrile bone marrow aplasia 17.86 9.88 11 382546 7314 63099151
Tardive dyskinesia 17.81 9.88 15 382542 8487 63097978
Intestinal diaphragm disease 17.80 9.88 10 382547 100 63106365
Skin cancer 17.79 9.88 26 382531 11469 63094996
Scar 17.77 9.88 143 382414 13639 63092826
Nodule 17.66 9.88 66 382491 20960 63085505
Maternal exposure timing unspecified 17.62 9.88 87 382470 7000 63099465
Joint injury 17.59 9.88 263 382294 29309 63077156
Food refusal 17.58 9.88 16 382541 359 63106106
Acute haemorrhagic oedema of infancy 17.57 9.88 6 382551 14 63106451
Depression 17.51 9.88 1393 381164 195099 62911366
Sleep disorder due to a general medical condition 17.50 9.88 29 382528 12159 63094306
Staphylococcal sepsis 17.45 9.88 14 382543 8114 63098351
Aplasia pure red cell 17.44 9.88 3 382554 4484 63101981
Panniculitis 17.42 9.88 123 382434 11262 63095203
Abnormal loss of weight 17.35 9.88 75 382482 5707 63100758
Jaundice 17.34 9.88 260 382297 28991 63077474
Sacroiliitis 17.33 9.88 51 382506 3206 63103259
Cholecystectomy 17.31 9.88 117 382440 10560 63095905
Liver injury 17.14 9.88 482 382075 60038 63046427
Arthritis 17.07 9.88 550 382007 115371 62991094
Peripheral venous disease 17.01 9.88 155 382402 15322 63091143
Injection site hyperaesthesia 17.01 9.88 8 382549 53 63106412
Cerebral infarction 16.97 9.88 80 382477 23813 63082652
Drug withdrawal headache 16.89 9.88 8 382549 54 63106411
Uterine leiomyoma 16.88 9.88 104 382453 9094 63097371
Dermo-hypodermitis 16.88 9.88 14 382543 276 63106189
Cerebral haemorrhage 16.86 9.88 112 382445 30617 63075848
Back pain 16.82 9.88 1828 380729 262317 62844148
Metastases to lung 16.80 9.88 32 382525 12718 63093747
Effusion 16.79 9.88 34 382523 1684 63104781
Pulmonary fibrosis 16.76 9.88 156 382401 39653 63066812
Haematochezia 16.75 9.88 432 382125 53112 63053353
Renal disorder 16.71 9.88 123 382434 32851 63073614
Scleroderma 16.70 9.88 6 382551 5456 63101009
Hemiplegia 16.58 9.88 19 382538 9304 63097161
Granuloma skin 16.51 9.88 97 382460 8340 63098125
Shoulder injury related to vaccine administration 16.47 9.88 4 382553 0 63106465
Bunion operation 16.44 9.88 29 382528 1293 63105172
Deafness 16.40 9.88 173 382384 17784 63088681
Malnutrition 16.39 9.88 43 382514 15255 63091210
Cognitive disorder 16.38 9.88 237 382320 55578 63050887
Coma scale abnormal 16.36 9.88 68 382489 5085 63101380
Clostridium difficile colitis 16.36 9.88 66 382491 20503 63085962
Glomerulonephritis minimal lesion 16.30 9.88 13 382544 242 63106223
Electrocardiogram QRS complex prolonged 16.29 9.88 75 382482 5863 63100602
Female genital tract fistula 16.25 9.88 13 382544 7546 63098919
Spinal fracture 16.24 9.88 56 382501 18215 63088250
Erythema multiforme 16.23 9.88 111 382446 10058 63096407
Atrial tachycardia 16.12 9.88 3 382554 4237 63102228
Skin papilloma 16.11 9.88 66 382491 4903 63101562
pH body fluid decreased 16.03 9.88 6 382551 20 63106445
Accidental exposure to product by child 15.92 9.88 27 382530 1166 63105299
Glomerulonephritis acute 15.85 9.88 9 382548 92 63106373
Pulmonary mass 15.85 9.88 76 382481 22520 63083945
Ulcer 15.85 9.88 233 382324 25874 63080591
Hepatic infiltration eosinophilic 15.81 9.88 6 382551 21 63106444
Nephritis allergic 15.62 9.88 12 382545 211 63106254
Fistula 15.61 9.88 24 382533 10369 63096096
Psychogenic tremor 15.60 9.88 6 382551 22 63106443
Pulmonary toxicity 15.57 9.88 104 382453 9351 63097114
Alanine aminotransferase abnormal 15.54 9.88 61 382496 4443 63102022
Pituitary tumour benign 15.51 9.88 36 382521 1959 63104506
Congestive cardiomyopathy 15.47 9.88 9 382548 6173 63100292
Dystonia 15.46 9.88 38 382519 13781 63092684
Conjunctival hyperaemia 15.38 9.88 40 382517 2339 63104126
Hallucination, auditory 15.36 9.88 34 382523 12790 63093675
Trichiasis 15.34 9.88 8 382549 68 63106397
Muscle tone disorder 15.31 9.88 10 382547 134 63106331
Pneumonitis 15.28 9.88 137 382420 35085 63071380
Atrial flutter 15.23 9.88 22 382535 9750 63096715
Adrenal insufficiency 15.20 9.88 56 382501 17859 63088606
Drug abuse 15.18 9.88 557 382000 71961 63034504
Blood copper decreased 15.16 9.88 5 382552 10 63106455
Focal peritonitis 15.16 9.88 5 382552 10 63106455
Drug dose omission by device 15.15 9.88 5 382552 4796 63101669
Orbital compartment syndrome 15.15 9.88 8 382549 70 63106395
Escherichia infection 15.13 9.88 34 382523 12720 63093745
Fear of injection 15.09 9.88 84 382473 7080 63099385
Genital pain 15.08 9.88 16 382541 435 63106030
SJS-TEN overlap 15.06 9.88 15 382542 378 63106087
Intentional product misuse 15.05 9.88 477 382080 60440 63046025
Pneumonia fungal 15.04 9.88 7 382550 5448 63101017
Anoxia 15.02 9.88 12 382545 224 63106241
Selenium deficiency 15.00 9.88 6 382551 25 63106440
Erosive duodenitis 15.00 9.88 16 382541 438 63106027
Fear of disease 14.98 9.88 28 382529 1306 63105159
Haemorrhage 14.95 9.88 268 382289 60754 63045711
Superior sagittal sinus thrombosis 14.91 9.88 21 382536 770 63105695
Papillitis 14.82 9.88 6 382551 26 63106439
Abdominal tenderness 14.78 9.88 92 382465 8074 63098391
Encephalopathy 14.73 9.88 155 382402 38465 63068000
Tendon disorder 14.72 9.88 72 382485 5771 63100694
Therapy partial responder 14.71 9.88 26 382531 10632 63095833
Hypertonia neonatal 14.66 9.88 12 382545 232 63106233
Anaphylactic reaction 14.64 9.88 511 382046 65589 63040876
Chronic sinusitis 14.62 9.88 35 382522 12808 63093657
Dyspareunia 14.58 9.88 40 382517 2415 63104050
Arthropathy 14.55 9.88 1622 380935 233170 62873295
Toxic encephalopathy 14.54 9.88 11 382546 6568 63099897
Normochromic anaemia 14.53 9.88 13 382544 285 63106180
Hypogammaglobulinaemia 14.53 9.88 13 382544 7142 63099323
Mediastinal abscess 14.47 9.88 6 382551 28 63106437
Necrotising colitis 14.44 9.88 18 382539 585 63105880
Product administration error 14.43 9.88 202 382355 22195 63084270
Joint destruction 14.41 9.88 10 382547 6242 63100223
Oesophageal discomfort 14.38 9.88 11 382546 192 63106273
Device occlusion 14.32 9.88 14 382543 7373 63099092
Grief reaction 14.28 9.88 12 382545 241 63106224
Device leakage 14.28 9.88 13 382544 7083 63099382
COVID-19 14.27 9.88 547 382010 112556 62993909
Prescribed overdose 14.26 9.88 287 382270 33866 63072599
Salivary gland cyst 14.25 9.88 4 382553 3 63106462
Blood iron abnormal 14.20 9.88 3 382554 3873 63102592
Circulatory collapse 14.19 9.88 198 382359 21740 63084725
Asphyxia 14.10 9.88 10 382547 6171 63100294
Tremor 14.07 9.88 652 381905 131587 62974878
Lymphoma 14.04 9.88 33 382524 12154 63094311
Paraesthesia 14.01 9.88 1113 381444 155853 62950612
Duodenal ulcer repair 14.00 9.88 7 382550 54 63106411
Evans syndrome 13.96 9.88 11 382546 201 63106264
Subarachnoid haemorrhage 13.93 9.88 42 382515 14241 63092224
Drug-induced liver injury 13.92 9.88 329 382228 39893 63066572
Thrombophlebitis septic 13.92 9.88 10 382547 158 63106307
Weight decreased 13.85 9.88 1458 381099 275340 62831125
Tissue infiltration 13.83 9.88 18 382539 611 63105854
Blood test abnormal 13.83 9.88 48 382509 15581 63090884
Personality disorder 13.79 9.88 9 382548 5802 63100663
Allergic respiratory disease 13.75 9.88 8 382549 86 63106379
Vulvovaginitis trichomonal 13.75 9.88 5 382552 15 63106450
Renal ischaemia 13.74 9.88 18 382539 615 63105850
Upper gastrointestinal perforation 13.72 9.88 4 382553 4 63106461
Needle issue 13.71 9.88 26 382531 10350 63096115
Staphylococcal scalded skin syndrome 13.69 9.88 9 382548 122 63106343
Acidosis 13.65 9.88 115 382442 11118 63095347
Product substitution issue 13.57 9.88 50 382507 15946 63090519
Listless 13.55 9.88 43 382514 2817 63103648
Cystitis haemorrhagic 13.54 9.88 4 382553 4119 63102346
Coagulopathy 13.53 9.88 186 382371 20358 63086107
Ludwig angina 13.52 9.88 8 382549 89 63106376
Alveolar rhabdomyosarcoma 13.51 9.88 5 382552 16 63106449
Atrioventricular block complete 13.43 9.88 18 382539 8233 63098232
Haemorrhage intracranial 13.42 9.88 39 382518 13380 63093085
Wheelchair user 13.42 9.88 11 382546 6308 63100157
Chromaturia 13.41 9.88 157 382400 16560 63089905
Pregnancy with contraceptive device 13.41 9.88 60 382497 4634 63101831
Disseminated intravascular coagulation 13.41 9.88 64 382493 18987 63087478
Small intestinal stenosis 13.37 9.88 17 382540 564 63105901
Costovertebral angle tenderness 13.37 9.88 8 382549 91 63106374
Splenic vein thrombosis 13.36 9.88 13 382544 318 63106147
Urogenital haemorrhage 13.34 9.88 12 382545 265 63106200
Laryngeal dyspnoea 13.30 9.88 10 382547 170 63106295
Genitourinary symptom 13.28 9.88 7 382550 61 63106404
Alpha 1 microglobulin increased 13.28 9.88 7 382550 61 63106404
Coronavirus infection 13.23 9.88 56 382501 4222 63102243
Pseudomonas infection 13.21 9.88 30 382527 11183 63095282
Tuberculosis 13.20 9.88 30 382527 11181 63095284
Upper limb fracture 13.18 9.88 64 382493 18904 63087561
Hyperuricaemia 13.18 9.88 8 382549 5362 63101103
Orthopnoea 13.17 9.88 11 382546 6250 63100215
No adverse event 13.16 9.88 173 382384 41232 63065233
Hyperacusis 13.13 9.88 35 382522 2078 63104387
Prescribed underdose 13.09 9.88 115 382442 29574 63076891
Palmar-plantar erythrodysaesthesia syndrome 13.08 9.88 83 382474 22932 63083533
Hyperventilation 13.08 9.88 72 382485 6044 63100421
Hepatitis acute 13.07 9.88 97 382460 9023 63097442
Transient ischaemic attack 13.02 9.88 155 382402 37598 63068867
Total bile acids increased 12.98 9.88 9 382548 134 63106331
Sinus node dysfunction 12.94 9.88 6 382551 4679 63101786
Vulval ulceration 12.91 9.88 13 382544 332 63106133
Hypothyroidism 12.87 9.88 180 382377 42452 63064013
Pulmonary valve disease 12.86 9.88 5 382552 19 63106446
Neuroleptic malignant syndrome 12.83 9.88 34 382523 12022 63094443
Forced expiratory volume decreased 12.76 9.88 7 382550 4961 63101504
Hyperlactacidaemia 12.75 9.88 42 382515 2807 63103658
Benzodiazepine drug level increased 12.73 9.88 10 382547 182 63106283
Pasteurella infection 12.72 9.88 7 382550 67 63106398
Therapeutic response decreased 12.72 9.88 278 382279 61247 63045218
Nerve injury 12.71 9.88 103 382454 9843 63096622
Tremor neonatal 12.70 9.88 9 382548 139 63106326
Substance abuser 12.66 9.88 5 382552 20 63106445
Cross sensitivity reaction 12.62 9.88 35 382522 2127 63104338
Adenovirus infection 12.61 9.88 3 382554 3568 63102897
Colitis 12.57 9.88 211 382346 48317 63058148
Schizoaffective disorder 12.56 9.88 3 382554 3559 63102906
Catheterisation cardiac 12.55 9.88 6 382551 4597 63101868
Small intestine ulcer 12.54 9.88 13 382544 344 63106121
Drug ineffective for unapproved indication 12.47 9.88 138 382419 33925 63072540
Pyoderma streptococcal 12.47 9.88 4 382553 7 63106458
Epistaxis 12.46 9.88 338 382219 72387 63034078
Glycosylated haemoglobin increased 12.43 9.88 36 382521 12362 63094103
Throat tightness 12.42 9.88 215 382342 24672 63081793
Facial spasm 12.36 9.88 18 382539 681 63105784
Peritonitis bacterial 12.35 9.88 7 382550 4872 63101593
Microsleep 12.35 9.88 3 382554 0 63106465
Corrosive gastritis 12.35 9.88 3 382554 0 63106465
Anastomotic ulcer perforation 12.35 9.88 3 382554 0 63106465
Foetal non-stress test 12.35 9.88 3 382554 0 63106465
Barbiturates positive 12.35 9.88 3 382554 0 63106465
Laryngeal web 12.35 9.88 3 382554 0 63106465
Chemical burn 12.34 9.88 14 382543 411 63106054
COVID-19 pneumonia 12.33 9.88 44 382513 14165 63092300
Enanthema 12.32 9.88 14 382543 412 63106053
Upper-airway cough syndrome 12.31 9.88 32 382525 11386 63095079
Emphysema 12.30 9.88 30 382527 10908 63095557
Streptococcal endocarditis 12.25 9.88 6 382551 44 63106421
Anti-thyroid antibody positive 12.21 9.88 14 382543 416 63106049
Substance dependence 12.19 9.88 10 382547 194 63106271
Gastric haemorrhage 12.16 9.88 73 382484 6325 63100140
Head injury 12.13 9.88 106 382451 27290 63079175
Henoch-Schonlein purpura nephritis 12.11 9.88 5 382552 23 63106442
Renal tubular necrosis 12.08 9.88 117 382440 11761 63094704
Pancreatic carcinoma 12.06 9.88 17 382540 7611 63098854
Base excess 12.05 9.88 7 382550 75 63106390
Dermatitis atopic 12.05 9.88 100 382457 9624 63096841
Inappropriate antidiuretic hormone secretion 12.05 9.88 50 382507 15412 63091053
Localised infection 12.03 9.88 120 382437 30090 63076375
Acquired haemophilia 12.03 9.88 22 382535 1009 63105456
Subdural haematoma 12.02 9.88 45 382512 14283 63092182
Osteochondrosis 11.99 9.88 26 382531 1351 63105114
Quadriparesis 11.99 9.88 33 382524 1996 63104469
Blood pressure diastolic abnormal 11.98 9.88 46 382511 14496 63091969
Delusion 11.97 9.88 35 382522 11982 63094483
Human papilloma virus test positive 11.94 9.88 16 382541 559 63105906
Narrow anterior chamber angle 11.92 9.88 6 382551 47 63106418
Blood pressure systolic abnormal 11.92 9.88 41 382516 13345 63093120
Brain injury 11.92 9.88 78 382479 6965 63099500
Autoimmune hepatitis 11.91 9.88 90 382467 8420 63098045
Retroplacental haematoma 11.87 9.88 9 382548 155 63106310
Gastric infection 11.85 9.88 47 382510 3440 63103025
Atypical femur fracture 11.85 9.88 9 382548 5363 63101102
Thyroid stimulating immunoglobulin increased 11.82 9.88 7 382550 78 63106387
Hyperchromic anaemia 11.81 9.88 6 382551 48 63106417
Lice infestation 11.81 9.88 4 382553 9 63106456
Generalised oedema 11.81 9.88 52 382505 15766 63090699
Strawberry tongue 11.78 9.88 5 382552 25 63106440
Abnormal clotting factor 11.77 9.88 8 382549 115 63106350
Photophobia 11.75 9.88 160 382397 17475 63088990
Persistent depressive disorder 11.74 9.88 22 382535 1028 63105437
Basal ganglion degeneration 11.74 9.88 14 382543 434 63106031
Amniotic fluid volume decreased 11.72 9.88 15 382542 501 63105964
Polymenorrhagia 11.71 9.88 6 382551 49 63106416
Rash maculo-papular 11.69 9.88 263 382294 31633 63074832
Anion gap 11.62 9.88 25 382532 1292 63105173
Platelet aggregation decreased 11.62 9.88 5 382552 26 63106439
Medical diet 11.62 9.88 5 382552 26 63106439
Monoplegia 11.58 9.88 44 382513 3157 63103308
Allodynia 11.55 9.88 19 382538 800 63105665
Hypothermia 11.55 9.88 129 382428 13452 63093013
Anti-transglutaminase antibody 11.52 9.88 4 382553 10 63106455
Nuchal rigidity 11.50 9.88 17 382540 652 63105813
Rhinorrhoea 11.44 9.88 304 382253 65273 63041192
Peripheral sensory neuropathy 11.39 9.88 17 382540 7434 63099031
Glomerulonephropathy 11.38 9.88 7 382550 84 63106381
International normalised ratio increased 11.34 9.88 204 382353 46221 63060244
Sinus disorder 11.32 9.88 94 382463 24459 63082006
Skin test negative 11.25 9.88 4 382553 11 63106454
Pneumoperitoneum 11.18 9.88 26 382531 1417 63105048
Mouth ulceration 11.16 9.88 136 382421 32848 63073617
Low birth weight baby 11.16 9.88 16 382541 7113 63099352
Ischaemic stroke 11.13 9.88 63 382494 17894 63088571
Granuloma 11.12 9.88 66 382491 5695 63100770
Electrolyte imbalance 11.10 9.88 73 382484 20003 63086462
Systemic mastocytosis 11.09 9.88 9 382548 172 63106293
Nasal polyps 11.08 9.88 12 382545 6027 63100438
Haemoptysis 11.07 9.88 115 382442 28611 63077854
Xanthoma 11.03 9.88 6 382551 56 63106409
Allergy test positive 11.01 9.88 16 382541 604 63105861
Eosinophilia 11.00 9.88 86 382471 22670 63083795
Alanine aminotransferase increased 10.99 9.88 746 381811 103024 63003441
Lupus-like syndrome 10.99 9.88 51 382506 15244 63091221
Caesarean section 10.97 9.88 59 382498 16973 63089492
Carotid artery dissection 10.96 9.88 9 382548 175 63106290
Eye infection 10.95 9.88 37 382520 12108 63094357
Anal haemorrhage 10.94 9.88 33 382524 2103 63104362
Suicidal ideation 10.86 9.88 470 382087 61951 63044514
Abscess rupture 10.86 9.88 11 382546 283 63106182
Transverse sinus thrombosis 10.79 9.88 15 382542 543 63105922
Hepatobiliary scan abnormal 10.77 9.88 6 382551 59 63106406
Inflammatory bowel disease 10.77 9.88 50 382507 3923 63102542
Bone loss 10.72 9.88 42 382515 3057 63103408
Neonatal hypoxia 10.72 9.88 16 382541 619 63105846
Clostridium test positive 10.71 9.88 3 382554 3198 63103267
Gastrooesophageal reflux disease 10.69 9.88 469 382088 95170 63011295
Vulval disorder 10.68 9.88 19 382538 853 63105612
Hallucination 10.67 9.88 250 382307 54567 63051898
Product storage error 10.67 9.88 50 382507 14906 63091559
Colitis ulcerative 10.66 9.88 103 382454 25988 63080477
Dialysis 10.65 9.88 30 382527 10397 63096068
Lymphoproliferative disorder 10.65 9.88 3 382554 3187 63103278
Oedema genital 10.62 9.88 9 382548 183 63106282
Oxygen saturation abnormal 10.58 9.88 4 382553 3525 63102940
Hepatic cancer 10.58 9.88 7 382550 4480 63101985
Flank pain 10.57 9.88 148 382409 16262 63090203
Lung opacity 10.54 9.88 3 382554 3165 63103300
Thyroid cancer 10.46 9.88 11 382546 5600 63100865
Gait deviation 10.43 9.88 6 382551 63 63106402
Blood lactate dehydrogenase increased 10.43 9.88 89 382468 23027 63083438
Vaginal ulceration 10.42 9.88 13 382544 423 63106042
Colon cancer 10.41 9.88 28 382529 9850 63096615
Hypokalaemia 10.40 9.88 515 382042 103289 63003176
Victim of abuse 10.40 9.88 7 382550 99 63106366
Coronary artery disease 10.39 9.88 135 382422 32242 63074223
Onychomycosis 10.37 9.88 20 382537 7912 63098553
Therapy non-responder 10.36 9.88 558 381999 75343 63031122
Chest wall abscess 10.35 9.88 6 382551 64 63106401
Akathisia 10.35 9.88 25 382532 9121 63097344
Syncope 10.33 9.88 590 381967 116795 62989670
Limbal stem cell deficiency 10.33 9.88 4 382553 15 63106450
Candida infection 10.33 9.88 115 382442 28236 63078229
Skin necrosis 10.31 9.88 129 382428 13821 63092644
Pleural fibrosis 10.30 9.88 4 382553 3468 63102997
Intestinal atony 10.29 9.88 3 382554 3 63106462
Uraemic gastropathy 10.29 9.88 3 382554 3 63106462
Pharyngeal lesion 10.29 9.88 3 382554 3 63106462
Pulmonary pneumatocele 10.29 9.88 3 382554 3 63106462
Meconium ileus 10.29 9.88 3 382554 3 63106462
Dermatitis bullous 10.28 9.88 87 382470 8421 63098044
Leukoencephalopathy 10.25 9.88 7 382550 4406 63102059
Blood glucose abnormal 10.23 9.88 20 382537 7872 63098593
Injection site pruritus 10.17 9.88 201 382356 44915 63061550
Heart rate increased 10.15 9.88 464 382093 93774 63012691
Myoglobin urine 10.13 9.88 4 382553 16 63106449
Treatment noncompliance 10.09 9.88 161 382396 37164 63069301
Speech disorder 10.09 9.88 178 382379 40451 63066014
Pemphigoid 10.06 9.88 18 382539 7326 63099139
Implant site pain 10.06 9.88 35 382522 2405 63104060
Glucose tolerance impaired 10.06 9.88 15 382542 6562 63099903
Lymphopenia 9.95 9.88 67 382490 18260 63088205
Wrist fracture 9.94 9.88 45 382512 13542 63092923
Breast cancer recurrent 9.93 9.88 7 382550 4334 63102131
Hyperthyroidism 9.92 9.88 50 382507 14623 63091842
Helicobacter gastritis 9.90 9.88 27 382530 1625 63104840

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
Angioedema 557.89 10.22 759 155538 36615 34764019
Intentional overdose 506.34 10.22 787 155510 42887 34757747
Suicide attempt 360.67 10.22 636 155661 38480 34762154
Haematemesis 333.17 10.22 508 155789 27203 34773431
Drug hypersensitivity 309.80 10.22 926 155371 79603 34721031
Melaena 301.58 10.22 556 155741 34824 34765810
Death 263.80 10.22 907 155390 397142 34403492
Urticaria 263.64 10.22 742 155555 61635 34738999
Aspirin-exacerbated respiratory disease 251.67 10.22 86 156211 301 34800333
Febrile neutropenia 250.27 10.22 151 156146 136698 34663936
Lip oedema 242.07 10.22 149 156148 2464 34798170
Off label use 231.84 10.22 1028 155269 418496 34382138
Completed suicide 224.07 10.22 951 155346 97217 34703417
Anaphylactic reaction 216.49 10.22 459 155838 31842 34768792
Tubulointerstitial nephritis 212.28 10.22 356 155941 20668 34779966
Gastric ulcer 209.77 10.22 302 155995 15348 34785286
Gastric haemorrhage 204.77 10.22 241 156056 10020 34790614
Acute kidney injury 182.75 10.22 2124 154173 302864 34497770
Overdose 182.70 10.22 849 155448 90210 34710424
Duodenal ulcer 180.70 10.22 227 156070 10105 34790529
Upper gastrointestinal haemorrhage 179.60 10.22 370 155927 25148 34775486
Pneumonia 166.60 10.22 947 155350 361680 34438954
Neutropenia 166.44 10.22 278 156019 156500 34644134
Glomerulonephritis minimal lesion 160.83 10.22 66 156231 425 34800209
Interstitial lung disease 157.43 10.22 48 156249 65234 34735400
Gastritis 138.71 10.22 304 155993 21569 34779065
Platelet count decreased 135.80 10.22 203 156094 119514 34681120
Face oedema 135.37 10.22 209 156088 11307 34789327
Gastrointestinal haemorrhage 130.94 10.22 758 155539 87719 34712915
Toxicity to various agents 124.87 10.22 1407 154890 198955 34601679
Ankylosing spondylitis 124.25 10.22 139 156158 5465 34795169
Gastric ulcer perforation 120.07 10.22 69 156228 999 34799635
Abdominal pain upper 118.78 10.22 632 155665 70858 34729776
Peptic ulcer 116.72 10.22 98 156199 2685 34797949
Metabolic acidosis 114.51 10.22 442 155855 43238 34757396
Duodenal ulcer haemorrhage 108.86 10.22 123 156174 4890 34795744
Palatal oedema 108.51 10.22 60 156237 803 34799831
Sepsis 105.46 10.22 386 155911 166175 34634459
Disease progression 101.84 10.22 206 156091 107871 34692763
Cardiac failure 97.48 10.22 161 156136 91087 34709547
Gastritis erosive 96.90 10.22 126 156171 5806 34794828
Meningitis aseptic 96.69 10.22 94 156203 3130 34797504
Eyelid oedema 95.09 10.22 116 156181 5008 34795626
Pancytopenia 93.43 10.22 177 156120 94980 34705654
Duodenal ulcer perforation 93.33 10.22 69 156228 1563 34799071
Thrombocytopenia 91.26 10.22 374 155923 155873 34644761
Fixed eruption 90.82 10.22 69 156228 1631 34799003
Stevens-Johnson syndrome 88.94 10.22 232 156065 18407 34782227
Cardiac failure congestive 87.02 10.22 149 156148 83121 34717513
Enthesopathy 84.91 10.22 104 156193 4509 34796125
Gastric ulcer haemorrhage 84.49 10.22 113 156184 5353 34795281
Psoriatic arthropathy 81.09 10.22 233 156064 19565 34781069
Renal papillary necrosis 80.69 10.22 30 156267 142 34800492
Wound closure 78.52 10.22 24 156273 52 34800582
Malignant neoplasm progression 77.76 10.22 174 156123 87872 34712762
Osteotomy 77.31 10.22 24 156273 56 34800578
Cytomegalovirus infection 73.18 10.22 14 156283 26121 34774513
Intentional product misuse 72.18 10.22 398 155899 45213 34755421
Headache 71.85 10.22 1278 155019 199357 34601277
Hypersensitivity 70.44 10.22 491 155806 60544 34740090
Drug resistance 70.28 10.22 15 156282 25912 34774722
Self-medication 68.59 10.22 72 156225 2631 34798003
Peritonsillar abscess 68.57 10.22 34 156263 358 34800276
Tongue oedema 67.58 10.22 75 156222 2922 34797712
Ascites 66.46 10.22 66 156231 46505 34754129
Tenosynovitis 65.38 10.22 91 156206 4479 34796155
Renal tubular acidosis 64.69 10.22 65 156232 2254 34798380
Vomiting 64.39 10.22 1504 154793 246117 34554517
Nasal obstruction 61.02 10.22 38 156259 642 34799992
Haematochezia 60.71 10.22 386 155911 46148 34754486
Intestinal diaphragm disease 60.21 10.22 27 156270 222 34800412
Fractional exhaled nitric oxide increased 60.20 10.22 45 156252 1037 34799597
Acute hepatic failure 59.94 10.22 168 156129 13906 34786728
Hepatic function abnormal 59.78 10.22 66 156231 44297 34756337
White blood cell count decreased 59.15 10.22 223 156074 95222 34705412
Acute generalised exanthematous pustulosis 58.33 10.22 107 156190 6669 34793965
Pain 56.55 10.22 1254 155043 203421 34597213
Lip swelling 56.21 10.22 179 156118 15901 34784733
Faeces discoloured 56.06 10.22 170 156127 14708 34785926
Tongue disorder 56.00 10.22 92 156205 5247 34795387
Plantar fasciitis 54.83 10.22 57 156240 2059 34798575
Hospitalisation 54.81 10.22 107 156190 56795 34743839
Brain empyema 54.70 10.22 13 156284 3 34800631
Glomerulonephritis membranous 54.05 10.22 44 156253 1153 34799481
Swelling face 52.72 10.22 224 156073 22881 34777753
Periorbital oedema 52.46 10.22 74 156223 3688 34796946
Tendonitis 52.32 10.22 122 156175 9018 34791616
Hyperhidrosis 51.35 10.22 541 155756 75151 34725483
Toxic epidermal necrolysis 50.28 10.22 211 156086 21435 34779199
IgM nephropathy 50.19 10.22 20 156277 118 34800516
Suspected suicide 50.05 10.22 82 156215 4666 34795968
Renal cortical necrosis 49.70 10.22 23 156274 205 34800429
Septic shock 49.08 10.22 161 156136 71673 34728961
Sensation of foreign body 48.42 10.22 61 156236 2722 34797912
Foreign body in throat 48.11 10.22 18 156279 87 34800547
Eye swelling 47.26 10.22 124 156173 9871 34790763
Exostosis 46.36 10.22 79 156218 4644 34795990
Neutrophil count decreased 45.91 10.22 100 156197 51004 34749630
Musculoskeletal stiffness 43.95 10.22 358 155939 46322 34754312
Bone marrow failure 43.43 10.22 40 156257 29213 34771421
Neuropathy peripheral 43.29 10.22 208 156089 83055 34717579
Analgesic drug level increased 41.92 10.22 33 156264 823 34799811
Nipple swelling 41.84 10.22 23 156274 304 34800330
Pruritus 41.43 10.22 877 155420 141104 34659530
Pyloric stenosis 41.32 10.22 33 156264 841 34799793
Mucocutaneous disorder 40.72 10.22 17 156280 115 34800519
Head discomfort 40.60 10.22 69 156228 4047 34796587
Respiratory failure 39.74 10.22 303 155994 108269 34692365
Coronavirus infection 39.61 10.22 70 156227 4237 34796397
Conjunctivitis 39.52 10.22 114 156183 9591 34791043
Jejunal ulcer perforation 39.04 10.22 15 156282 79 34800555
Intentional product use issue 38.86 10.22 137 156160 59679 34740955
Product used for unknown indication 37.93 10.22 33 156264 950 34799684
Arthralgia 37.91 10.22 1012 155285 169029 34631605
Full blood count abnormal 37.87 10.22 18 156279 18650 34781984
Joint swelling 37.35 10.22 421 155876 59469 34741165
Kounis syndrome 37.31 10.22 51 156246 2467 34798167
Macrocephaly 37.24 10.22 25 156272 483 34800151
Laryngeal dyspnoea 36.76 10.22 15 156282 95 34800539
Myocardial infarction 36.68 10.22 355 155942 120730 34679904
Erythema multiforme 36.59 10.22 103 156194 8546 34792088
Tropical infectious disease 36.50 10.22 12 156285 36 34800598
Type I hypersensitivity 36.38 10.22 37 156260 1302 34799332
Discoloured vomit 36.36 10.22 25 156272 503 34800131
Medication overuse headache 36.27 10.22 16 156281 126 34800508
Erosive oesophagitis 34.75 10.22 38 156259 1456 34799178
Blood glucose increased 34.48 10.22 167 156130 66551 34734083
Cardiogenic shock 34.34 10.22 41 156256 26577 34774057
Myoglobin blood increased 34.32 10.22 54 156243 2969 34797665
Clostridium difficile infection 34.27 10.22 21 156276 18877 34781757
Pneumocystis jirovecii pneumonia 34.24 10.22 23 156274 19687 34780947
Peptic ulcer perforation 34.19 10.22 18 156279 217 34800417
Dactylitis 33.67 10.22 30 156267 892 34799742
Encephalopathy 33.50 10.22 67 156230 35252 34765382
Renal tubular necrosis 33.46 10.22 149 156148 15531 34785103
Graft versus host disease 33.38 10.22 4 156293 10565 34790069
Plasma cell myeloma 33.21 10.22 88 156209 41949 34758685
Chronic obstructive pulmonary disease 33.15 10.22 110 156187 48808 34751826
Mast cell activation syndrome 33.14 10.22 18 156279 232 34800402
Confusional state 32.99 10.22 450 155847 143710 34656924
Flank pain 32.97 10.22 84 156213 6567 34794067
Sacroiliitis 32.94 10.22 37 156260 1461 34799173
Weight increased 32.93 10.22 262 156035 92771 34707863
Neck pain 32.88 10.22 210 156087 25139 34775495
Duodenitis 32.77 10.22 69 156228 4759 34795875
Hypoxia 32.65 10.22 131 156166 54964 34745670
Myelodysplastic syndrome 32.59 10.22 23 156274 19185 34781449
Ulcer 32.40 10.22 100 156197 8735 34791899
Hypomagnesaemia 32.29 10.22 30 156267 21821 34778813
Pneumonia necrotising 31.93 10.22 27 156270 747 34799887
Meningitis pneumococcal 31.86 10.22 17 156280 211 34800423
Heart rate decreased 31.17 10.22 59 156238 31686 34768948
Product prescribing error 31.02 10.22 192 156105 22735 34777899
Pigment nephropathy 30.90 10.22 7 156290 0 34800634
Haemophilia 30.87 10.22 8 156289 6 34800628
Oesophageal oedema 30.32 10.22 8 156289 7 34800627
Wrong technique in product usage process 30.23 10.22 73 156224 35913 34764721
Oxygen saturation decreased 30.01 10.22 131 156166 53687 34746947
Psoriasis 29.97 10.22 285 156012 38527 34762107
Bronchopulmonary aspergillosis 29.94 10.22 14 156283 14645 34785989
Tunnel vision 29.90 10.22 23 156274 554 34800080
Cerebral infarction 29.70 10.22 48 156249 27407 34773227
Pharyngeal abscess 29.69 10.22 21 156276 443 34800191
Inadequate analgesia 29.51 10.22 50 156247 2925 34797709
Intentional self-injury 29.49 10.22 131 156166 13640 34786994
Drug-induced liver injury 29.26 10.22 225 156072 28607 34772027
Exposure to toxic agent 29.10 10.22 56 156241 3619 34797015
Diarrhoea 28.95 10.22 1437 154860 388475 34412159
Gastritis haemorrhagic 28.81 10.22 34 156263 1417 34799217
Conjunctival hyperaemia 28.79 10.22 44 156253 2358 34798276
Nephrolithiasis 28.74 10.22 233 156064 30100 34770534
Cytokine release syndrome 28.71 10.22 36 156261 22841 34777793
Fluid retention 28.16 10.22 48 156249 26839 34773795
Muscle swelling 28.12 10.22 19 156278 371 34800263
Back pain 28.03 10.22 728 155569 121061 34679573
Transplant rejection 27.87 10.22 6 156291 10305 34790329
Cytopenia 27.82 10.22 11 156286 12712 34787922
Atrial fibrillation 27.65 10.22 383 155914 122010 34678624
Incorrect route of product administration 27.62 10.22 16 156281 14829 34785805
Beta haemolytic streptococcal infection 27.26 10.22 21 156276 507 34800127
Tonsillitis 27.21 10.22 43 156254 2373 34798261
Intervertebral disc protrusion 27.10 10.22 102 156195 9854 34790780
Scleroderma renal crisis 27.06 10.22 16 156281 245 34800389
Hypoglycaemia 26.95 10.22 139 156158 54501 34746133
Ventricular tachyarrhythmia 26.45 10.22 18 156279 356 34800278
Febrile bone marrow aplasia 26.19 10.22 3 156294 8206 34792428
Red blood cell count decreased 26.06 10.22 57 156240 29033 34771601
Synovitis 25.87 10.22 128 156169 13938 34786696
Pulmonary embolism 25.55 10.22 267 156030 89479 34711155
Pelvic haematoma 25.41 10.22 14 156283 186 34800448
Posthaemorrhagic hydrocephalus 25.27 10.22 12 156285 114 34800520
Alanine aminotransferase abnormal 25.13 10.22 61 156236 4627 34796007
Diabetes mellitus 24.99 10.22 116 156181 46757 34753877
Transposition of the great vessels 24.97 10.22 19 156278 450 34800184
Dermo-hypodermitis 24.87 10.22 19 156278 453 34800181
Allergic respiratory disease 24.84 10.22 9 156288 39 34800595
Hypervolaemia 24.75 10.22 31 156266 19678 34780956
Milk-alkali syndrome 24.74 10.22 21 156276 584 34800050
Pathogen resistance 24.67 10.22 6 156291 9476 34791158
Myelosuppression 24.50 10.22 30 156267 19235 34781399
Bladder cancer 24.47 10.22 22 156275 16256 34784378
Erythema 24.46 10.22 544 155753 88236 34712398
Type IV hypersensitivity reaction 24.27 10.22 31 156266 1403 34799231
Oral pruritus 24.15 10.22 16 156281 302 34800332
Post concussion syndrome 23.99 10.22 12 156285 129 34800505
Cerebral atrophy congenital 23.91 10.22 10 156287 68 34800566
Multiple sclerosis relapse 23.79 10.22 119 156178 13014 34787620
Nightmare 23.71 10.22 127 156170 14264 34786370
Erysipelas 23.67 10.22 61 156236 4802 34795832
Intestinal obstruction 23.67 10.22 41 156256 22781 34777853
Nasal turbinate hypertrophy 23.49 10.22 11 156286 101 34800533
Tumour lysis syndrome 23.40 10.22 25 156272 17034 34783600
Coma 23.22 10.22 309 155988 45369 34755265
Cytomegalovirus viraemia 23.01 10.22 3 156294 7427 34793207
Liver injury 22.97 10.22 129 156168 14749 34785885
COVID-19 22.78 10.22 229 156068 77321 34723313
Clostridium difficile colitis 22.77 10.22 22 156275 15708 34784926
Neutropenic sepsis 22.69 10.22 17 156280 13750 34786884
Nasal disorder 22.67 10.22 35 156262 1893 34798741
Abnormal clotting factor 22.64 10.22 10 156287 79 34800555
Perforated ulcer 22.45 10.22 13 156284 191 34800443
Obstruction gastric 22.24 10.22 25 156272 988 34799646
Transaminases increased 22.23 10.22 200 156097 26623 34774011
Migraine 22.18 10.22 144 156153 17334 34783300
Nipple pain 22.08 10.22 24 156273 913 34799721
Prepyloric stenosis 22.07 10.22 5 156292 0 34800634
Benign familial pemphigus 22.07 10.22 5 156292 0 34800634
Kawasaki's disease 22.07 10.22 5 156292 0 34800634
Nausea 21.97 10.22 1784 154513 338124 34462510
Neurotoxicity 21.92 10.22 29 156268 17981 34782653
C-reactive protein abnormal 21.88 10.22 87 156210 8623 34792011
Pleural effusion 21.85 10.22 246 156051 81300 34719334
Neuroleptic malignant syndrome 21.70 10.22 29 156268 17905 34782729
Tobacco abuse 21.43 10.22 17 156280 429 34800205
Blood pressure fluctuation 21.38 10.22 51 156246 25198 34775436
Purpura fulminans 21.33 10.22 10 156287 92 34800542
Angular cheilitis 21.29 10.22 12 156285 167 34800467
Macrophages increased 21.23 10.22 12 156285 168 34800466
Kidney transplant rejection 21.02 10.22 4 156293 7493 34793141
Gastrointestinal injury 20.93 10.22 17 156280 444 34800190
Lemierre syndrome 20.82 10.22 7 156290 23 34800611
Red blood cell sedimentation rate 20.61 10.22 26 156271 1162 34799472
Cerebrovascular accident 20.38 10.22 262 156035 84549 34716085
Swelling of eyelid 20.37 10.22 25 156272 1086 34799548
Anaemia 20.29 10.22 845 155452 232490 34568144
Hypoaldosteronism 20.17 10.22 12 156285 186 34800448
Epistaxis 20.16 10.22 165 156132 58086 34742548
Musculoskeletal pain 20.06 10.22 225 156072 31738 34768896
Alcohol use 20.05 10.22 45 156252 3243 34797391
Pulmonary arterial hypertension 20.04 10.22 7 156290 8732 34791902
Hypothermia 19.90 10.22 98 156199 10650 34789984
Erosive duodenitis 19.85 10.22 31 156266 1693 34798941
Haematotoxicity 19.78 10.22 6 156291 8188 34792446
Secondary amyloidosis 19.56 10.22 9 156288 79 34800555
Nodal rhythm 19.55 10.22 28 156269 1415 34799219
Poisoning 19.54 10.22 107 156190 12119 34788515
Oesophageal rupture 19.54 10.22 16 156281 423 34800211
Post transplant lymphoproliferative disorder 19.36 10.22 3 156294 6525 34794109
Extra dose administered 19.22 10.22 50 156247 3959 34796675
Full blood count decreased 19.21 10.22 32 156265 18056 34782578
Pneumonitis 19.17 10.22 82 156215 33796 34766838
Pulmonary oedema 19.14 10.22 129 156168 47400 34753234
Granuloma skin 19.09 10.22 26 156271 1253 34799381
Hepatocellular carcinoma 19.06 10.22 5 156292 7504 34793130
Dermatomyositis 19.03 10.22 26 156271 1257 34799377
Streptococcal infection 18.98 10.22 57 156240 4904 34795730
Xyphoid retraction 18.98 10.22 11 156286 162 34800472
Mallory-Weiss syndrome 18.97 10.22 27 156270 1357 34799277
Vanishing bile duct syndrome 18.81 10.22 23 156274 995 34799639
Duodenal obstruction 18.69 10.22 11 156286 167 34800467
Meningitis streptococcal 18.68 10.22 7 156290 34 34800600
Diffuse large B-cell lymphoma 18.53 10.22 5 156292 7365 34793269
Sleep disorder 18.51 10.22 220 156077 31468 34769166
Renal hypoplasia 18.47 10.22 9 156288 91 34800543
Implant site extravasation 18.46 10.22 15 156282 392 34800242
Ocular icterus 18.44 10.22 40 156257 2817 34797817
Abdominal pain 18.36 10.22 901 155396 162717 34637917
Spinal pain 18.30 10.22 63 156234 5826 34794808
Helicobacter test positive 18.20 10.22 21 156276 854 34799780
Phonophobia 18.13 10.22 11 156286 177 34800457
Hypogammaglobulinaemia 18.10 10.22 6 156291 7734 34792900
Oesophagitis haemorrhagic 18.09 10.22 12 156285 227 34800407
Acute respiratory failure 18.03 10.22 74 156223 30854 34769780
Fall 18.00 10.22 733 155564 202152 34598482
Epiglottic oedema 17.97 10.22 11 156286 180 34800454
Epidermolysis 17.95 10.22 13 156284 285 34800349
Gastrointestinal hypermotility 17.94 10.22 10 156287 136 34800498
Shock haemorrhagic 17.90 10.22 99 156198 11255 34789379
Pyroglutamic acidosis 17.86 10.22 15 156282 411 34800223
Panniculitis 17.81 10.22 32 156265 1962 34798672
Burn oral cavity 17.66 10.22 4 156293 0 34800634
Tympanic membrane hyperaemia 17.66 10.22 4 156293 0 34800634
Asthmatic crisis 17.62 10.22 16 156281 488 34800146
Mucosal necrosis 17.61 10.22 8 156289 68 34800566
Ductus arteriosus stenosis foetal 17.60 10.22 11 156286 187 34800447
Oropharyngeal blistering 17.55 10.22 11 156286 188 34800446
Progressive multifocal leukoencephalopathy 17.50 10.22 11 156286 9753 34790881
Thrombosis 17.43 10.22 143 156154 50315 34750319
Angiocardiogram 17.40 10.22 11 156286 191 34800443
Intervertebral disc disorder 17.39 10.22 31 156266 1889 34798745
Lymphocyte count decreased 17.38 10.22 48 156249 22574 34778060
Prothrombin time abnormal 17.35 10.22 19 156278 729 34799905
Energy increased 17.29 10.22 25 156272 1275 34799359
Ventricular tachycardia 17.17 10.22 61 156236 26518 34774116
SJS-TEN overlap 17.12 10.22 13 156284 307 34800327
Acute myeloid leukaemia 17.03 10.22 35 156262 18235 34782399
Delirium 16.92 10.22 121 156176 43870 34756764
Asthenia 16.78 10.22 911 155386 244340 34556294
Aspergillus infection 16.76 10.22 18 156279 12236 34788398
Hepatic cancer 16.75 10.22 8 156289 8267 34792367
Otitis media acute 16.72 10.22 17 156280 598 34800036
Hypotension 16.55 10.22 816 155481 220833 34579801
Cognitive disorder 16.51 10.22 69 156228 28624 34772010
Necrotising soft tissue infection 16.49 10.22 8 156289 80 34800554
Drug ineffective 16.46 10.22 1790 154507 454961 34345673
International normalised ratio increased 16.40 10.22 134 156163 47193 34753441
Blood phosphorus increased 16.35 10.22 7 156290 7714 34792920
Constipation 16.29 10.22 477 155820 136505 34664129
Parkinsonism 16.27 10.22 8 156289 8130 34792504
Dysphonia 16.25 10.22 168 156129 23215 34777419
Tubulointerstitial nephritis and uveitis syndrome 16.24 10.22 8 156289 83 34800551
Congenital skin dimples 16.21 10.22 10 156287 166 34800468
Influenza like illness 16.21 10.22 192 156105 27442 34773192
Blood parathyroid hormone decreased 16.20 10.22 26 156271 1454 34799180
Akathisia 16.17 10.22 8 156289 8101 34792533
Torsade de pointes 16.15 10.22 6 156291 7203 34793431
Atrioventricular block complete 16.02 10.22 11 156286 9308 34791326
Portal vein phlebitis 16.01 10.22 5 156292 12 34800622
Anuria 16.00 10.22 90 156207 10295 34790339
Gastrointestinal ulcer 15.98 10.22 28 156269 1683 34798951
Gastrointestinal erosion 15.92 10.22 14 156283 409 34800225
Crying 15.91 10.22 60 156237 5802 34794832
Sebaceous gland disorder 15.87 10.22 6 156291 30 34800604
Symmetrical drug-related intertriginous and flexural exanthema 15.86 10.22 13 156284 344 34800290
Hyponatraemia 15.85 10.22 267 156030 82424 34718210
Urticaria chronic 15.83 10.22 8 156289 88 34800546
Pneumonia aspiration 15.76 10.22 116 156181 41787 34758847
Pneumonia fungal 15.75 10.22 6 156291 7094 34793540
Elbow operation 15.68 10.22 9 156288 130 34800504
Lung neoplasm malignant 15.65 10.22 34 156263 17361 34783273
Peritonitis bacterial 15.64 10.22 4 156293 6106 34794528
Ankle deformity 15.63 10.22 11 156286 230 34800404
Candida infection 15.63 10.22 35 156262 17680 34782954
Urinary tract infection 15.63 10.22 273 156024 83808 34716826
Pneumonia bacterial 15.62 10.22 18 156279 11854 34788780
Mucosal inflammation 15.46 10.22 105 156192 38517 34762117
Nasopharyngitis 15.43 10.22 416 155881 69552 34731082
Meconium ileus 15.40 10.22 6 156291 33 34800601
Ischaemic stroke 15.34 10.22 37 156260 18213 34782421
Hypertensive emergency 15.31 10.22 21 156276 1019 34799615
Hepatitis acute 15.30 10.22 71 156226 7530 34793104
Abdominal pain lower 15.24 10.22 90 156207 10481 34790153
Duodenal stenosis 15.23 10.22 11 156286 240 34800394
Product dose omission issue 15.21 10.22 413 155884 119298 34681336
Anterior interosseous syndrome 15.21 10.22 5 156292 15 34800619
Herbal interaction 15.18 10.22 13 156284 366 34800268
Hepatitis B 15.15 10.22 4 156293 5979 34794655
Respiratory fatigue 15.08 10.22 8 156289 98 34800536
Carpal tunnel syndrome 15.07 10.22 51 156246 4675 34795959
Inflammation 15.04 10.22 193 156104 28102 34772532
Blood bilirubin unconjugated 14.90 10.22 4 156293 4 34800630
Renal cancer 14.88 10.22 8 156289 7727 34792907
Ductus arteriosus premature closure 14.85 10.22 11 156286 250 34800384
Cervicobrachial syndrome 14.79 10.22 12 156285 313 34800321
Pharyngeal erythema 14.78 10.22 17 156280 689 34799945
Gastric mucosa erythema 14.77 10.22 11 156286 252 34800382
Acquired epidermolysis bullosa 14.74 10.22 5 156292 17 34800617
Medication error 14.72 10.22 177 156120 25388 34775246
Skin texture abnormal 14.70 10.22 6 156291 38 34800596
Blindness 14.58 10.22 28 156269 14958 34785676
Severe invasive streptococcal infection 14.57 10.22 6 156291 39 34800595
Infection masked 14.52 10.22 7 156290 69 34800565
Orthostatic hypotension 14.50 10.22 63 156234 25856 34774778
Lip erosion 14.48 10.22 16 156281 620 34800014
Cerebral calcification 14.47 10.22 8 156289 107 34800527
Tremor 14.45 10.22 271 156026 82316 34718318
Retinopathy of prematurity 14.40 10.22 9 156288 153 34800481
Coma scale abnormal 14.36 10.22 45 156252 3963 34796671
Agitation 14.34 10.22 347 155950 57052 34743582
Depression 14.29 10.22 550 155747 96548 34704086
Thrombosis mesenteric vessel 14.26 10.22 7 156290 72 34800562
Tongue injury 14.22 10.22 8 156289 111 34800523
Cardiomyopathy 14.19 10.22 34 156263 16774 34783860
Carbohydrate antigen 19-9 increased 14.18 10.22 10 156287 210 34800424
Dental operation 14.16 10.22 13 156284 402 34800232
Product label issue 14.12 10.22 11 156286 270 34800364
Dermatitis acneiform 14.12 10.22 5 156292 6184 34794450
Eye abscess 14.10 10.22 9 156288 159 34800475
Food intolerance 14.09 10.22 24 156273 1410 34799224
Rhabdomyolysis 14.09 10.22 217 156080 67946 34732688
Gastritis bacterial 14.05 10.22 10 156287 213 34800421
Microbiology test abnormal 14.02 10.22 4 156293 6 34800628
Product use in unapproved indication 14.00 10.22 409 155888 117090 34683544
Streptococcal sepsis 13.98 10.22 25 156272 1527 34799107
Apnoea 13.97 10.22 63 156234 6601 34794033
Joint effusion 13.96 10.22 53 156244 5140 34795494
Tendon disorder 13.93 10.22 36 156261 2839 34797795
Facet joint syndrome 13.88 10.22 11 156286 277 34800357
Hepatic cirrhosis 13.86 10.22 36 156261 17278 34783356
Costochondritis 13.75 10.22 15 156282 573 34800061
Gastric perforation 13.73 10.22 33 156264 2487 34798147
Deep vein thrombosis 13.73 10.22 207 156090 65041 34735593
Ejection fraction decreased 13.72 10.22 42 156255 19112 34781522
Onychomycosis 13.70 10.22 32 156265 2368 34798266
Spinal cord infection 13.53 10.22 9 156288 171 34800463
Ulcer haemorrhage 13.53 10.22 34 156263 2636 34797998
Drug reaction with eosinophilia and systemic symptoms 13.48 10.22 215 156082 32797 34767837
Oesophageal carcinoma 13.48 10.22 13 156284 9291 34791343
Multiple sclerosis 13.32 10.22 62 156235 6583 34794051
Coating in mouth 13.32 10.22 7 156290 84 34800550
Secretion discharge 13.27 10.22 57 156240 5848 34794786
Helicobacter test 13.24 10.22 3 156294 0 34800634
Atrio-oesophageal fistula 13.24 10.22 3 156294 0 34800634
Vestibular ataxia 13.24 10.22 3 156294 0 34800634
Oesophageal infection 13.20 10.22 11 156286 298 34800336
Stomatitis 13.13 10.22 124 156173 42390 34758244
Hyperammonaemia 13.13 10.22 6 156291 6361 34794273
Right ventricular failure 13.05 10.22 12 156285 8772 34791862
Nasal septum deviation 12.99 10.22 20 156277 1079 34799555
Ear canal stenosis 12.98 10.22 4 156293 9 34800625
Immune reconstitution inflammatory syndrome 12.97 10.22 12 156285 8747 34791887
Aortic bruit 12.93 10.22 10 156287 243 34800391
Ventriculo-peritoneal shunt 12.91 10.22 5 156292 27 34800607
Gastrointestinal pain 12.90 10.22 40 156257 3502 34797132
Cardiac failure acute 12.88 10.22 17 156280 10553 34790081
Neutrophil Pelger-Huet anomaly present 12.86 10.22 10 156287 245 34800389
Blood pressure diastolic decreased 12.84 10.22 13 156284 9081 34791553
Nasal polyps 12.81 10.22 32 156265 2471 34798163
Anaphylactic shock 12.77 10.22 118 156179 15823 34784811
Periorbital swelling 12.77 10.22 15 156282 622 34800012
Congestive cardiomyopathy 12.73 10.22 9 156288 7501 34793133
Bradycardia 12.72 10.22 249 156048 75169 34725465
Atrial septal defect 12.70 10.22 66 156231 7326 34793308
Orthostatic intolerance 12.70 10.22 17 156280 806 34799828
Superinfection 12.68 10.22 32 156265 2487 34798147
Acid-base balance disorder mixed 12.63 10.22 6 156291 57 34800577
Liver disorder 12.57 10.22 91 156206 32906 34767728
Lactic acidosis 12.57 10.22 222 156075 34550 34766084
Eye oedema 12.55 10.22 17 156280 815 34799819
Mental fatigue 12.55 10.22 8 156289 141 34800493
Photophobia 12.54 10.22 63 156234 6901 34793733
Blood pressure increased 12.51 10.22 299 155998 87803 34712831
Meningoencephalitis bacterial 12.45 10.22 8 156289 143 34800491
Product packaging issue 12.45 10.22 15 156282 639 34799995
Electrocardiogram QT shortened 12.31 10.22 8 156289 146 34800488
Sleep disorder due to a general medical condition 12.29 10.22 4 156293 5217 34795417
Staphylococcal abscess 12.29 10.22 15 156282 648 34799986
Severe acute respiratory syndrome 12.28 10.22 6 156291 61 34800573
Bezoar 12.22 10.22 20 156277 1137 34799497
Visceral pain 12.20 10.22 6 156291 62 34800572
Bronchospasm 12.17 10.22 86 156211 10645 34789989
Psychotic disorder 12.17 10.22 62 156235 24390 34776244
Anhidrosis 12.14 10.22 7 156290 102 34800532
Sinusitis 12.13 10.22 256 156041 41146 34759488
Blood pressure systolic increased 12.11 10.22 57 156240 22895 34777739
Pyrexia 12.10 10.22 1304 154993 331709 34468925
Oesophagitis 12.10 10.22 101 156196 13160 34787474
Capillary nail refill test abnormal 12.08 10.22 5 156292 33 34800601
Blood ethanol increased 12.06 10.22 13 156284 490 34800144
Spondylitis 12.05 10.22 21 156276 1257 34799377
Gastric cancer 11.99 10.22 7 156290 6462 34794172
Orbital oedema 11.99 10.22 8 156289 153 34800481
Presbyopia 11.98 10.22 9 156288 209 34800425
Oesophageal obstruction 11.95 10.22 13 156284 495 34800139
Rales 11.94 10.22 16 156281 9867 34790767
Cytomegalovirus infection reactivation 11.91 10.22 4 156293 5114 34795520
Bladder discomfort 11.90 10.22 8 156289 155 34800479
Rash 11.86 10.22 1153 155144 221599 34579035
Septic arthritis staphylococcal 11.78 10.22 13 156284 503 34800131
Necrotising colitis 11.75 10.22 19 156278 1069 34799565
Bone disorder 11.74 10.22 57 156240 6158 34794476
Bronchiectasis 11.70 10.22 16 156281 9785 34790849
Catatonia 11.57 10.22 4 156293 5021 34795613
Drug eruption 11.56 10.22 138 156159 19760 34780874
Dermatitis atopic 11.55 10.22 51 156246 5296 34795338
Oligohydramnios 11.55 10.22 11 156286 357 34800277
Complement factor C4 decreased 11.49 10.22 4 156293 15 34800619
Iritis 11.46 10.22 22 156275 1419 34799215
Lower gastrointestinal haemorrhage 11.46 10.22 77 156220 9375 34791259
Dementia 11.46 10.22 28 156269 13720 34786914
Emotional distress 11.43 10.22 110 156187 14916 34785718
Paraesthesia oral 11.42 10.22 43 156254 4154 34796480
Rheumatoid nodule 11.41 10.22 34 156263 2913 34797721
Vascular pseudoaneurysm 11.40 10.22 28 156269 2139 34798495
Noninfective gingivitis 11.39 10.22 11 156286 363 34800271
Ear injury 11.37 10.22 5 156292 39 34800595
Dyspepsia 11.37 10.22 229 156068 36503 34764131
Generalised oedema 11.37 10.22 24 156273 12384 34788250
Ureteric obstruction 11.35 10.22 20 156277 1208 34799426
Suprapubic pain 11.33 10.22 12 156285 443 34800191
Febrile convulsion 11.32 10.22 14 156283 613 34800021
Throat tightness 11.31 10.22 70 156227 8288 34792346
Hypoplastic anaemia 11.29 10.22 4 156293 16 34800618
Conjunctival erosion 11.29 10.22 4 156293 16 34800618
Prostate cancer 11.26 10.22 118 156179 39531 34761103
Kernicterus 11.18 10.22 3 156294 3 34800631
Oculoauriculovertebral dysplasia 11.18 10.22 3 156294 3 34800631
Spinal meningeal cyst 11.18 10.22 3 156294 3 34800631
Vertebral artery hypoplasia 11.18 10.22 3 156294 3 34800631
Cerebral haemorrhage 11.18 10.22 101 156196 34836 34765798
Posterior reversible encephalopathy syndrome 11.15 10.22 17 156280 9937 34790697
Bacterial infection 11.13 10.22 39 156258 17024 34783610
Spinal disorder 11.11 10.22 43 156254 4209 34796425
Antineutrophil cytoplasmic antibody 11.10 10.22 4 156293 17 34800617
Respiratory tract oedema 11.10 10.22 11 156286 375 34800259
Platelet function test abnormal 11.10 10.22 7 156290 121 34800513
Pulmonary hypertension 11.02 10.22 52 156245 20872 34779762
Fusobacterium infection 11.00 10.22 6 156291 78 34800556
Nasal flaring 10.92 10.22 4 156293 18 34800616
Drug tolerance 10.92 10.22 33 156264 2849 34797785
Osteomyelitis blastomyces 10.92 10.22 4 156293 18 34800616
Extrapyramidal disorder 10.92 10.22 26 156271 12854 34787780
Hypertriglyceridaemia 10.91 10.22 13 156284 8435 34792199
Incorrect dosage administered 10.91 10.22 20 156277 1246 34799388
Myasthenia gravis 10.89 10.22 9 156288 6931 34793703
Lumbar radiculopathy 10.89 10.22 16 156281 828 34799806
Escherichia pyelonephritis 10.87 10.22 6 156291 80 34800554
Transmission of an infectious agent via product 10.87 10.22 8 156289 180 34800454
Chest discomfort 10.85 10.22 320 155977 54210 34746424
Diabetes mellitus inadequate control 10.77 10.22 28 156269 13436 34787198
Enterocolitis 10.74 10.22 12 156285 8014 34792620
Paranasal sinus mucosal hypertrophy 10.74 10.22 6 156291 82 34800552
Systemic infection 10.72 10.22 49 156248 5163 34795471
Testicular operation 10.72 10.22 3 156294 4 34800630
Nasal septum perforation 10.71 10.22 7 156290 129 34800505
Syringe issue 10.69 10.22 6 156291 5658 34794976
Fungal infection 10.68 10.22 36 156261 15899 34784735
Adrenal insufficiency 10.64 10.22 30 156267 14017 34786617
Heat stroke 10.63 10.22 17 156280 948 34799686
Ligament injury 10.61 10.22 10 156287 320 34800314
Blood creatine phosphokinase increased 10.61 10.22 139 156158 44718 34755916
Arthritis 10.58 10.22 198 156099 31148 34769486
Pulmonary tuberculosis 10.58 10.22 4 156293 4750 34795884
Metatarsalgia 10.55 10.22 6 156291 85 34800549
Oral mucosa erosion 10.53 10.22 17 156280 955 34799679
Colostomy closure 10.48 10.22 5 156292 48 34800586
Focal segmental glomerulosclerosis 10.48 10.22 26 156271 1999 34798635
Application site haematoma 10.39 10.22 5 156292 49 34800585
Colonic abscess 10.36 10.22 12 156285 490 34800144
Oropharyngeal swelling 10.34 10.22 12 156285 491 34800143
Vision blurred 10.34 10.22 274 156023 45689 34754945
Pulmonary alveolar haemorrhage 10.31 10.22 11 156286 7501 34793133
Cardiac failure chronic 10.31 10.22 12 156285 7867 34792767
Bronchopulmonary dysplasia 10.23 10.22 13 156284 585 34800049

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
Intentional overdose 1394.36 9.86 2267 437410 103693 79201018
Angioedema 1074.51 9.86 1681 437996 74354 79230357
Suicide attempt 632.72 9.86 1407 438270 81525 79223186
Off label use 597.11 9.86 2776 436901 904439 78400272
Drug hypersensitivity 566.16 9.86 3188 436489 295728 79008983
Urticaria 520.61 9.86 2212 437465 182989 79121722
Injury 500.65 9.86 1232 438445 76264 79228447
Cholecystitis chronic 453.19 9.86 401 439276 9505 79295206
Febrile neutropenia 452.17 9.86 366 439311 230633 79074078
Death 448.49 9.86 1611 438066 564903 78739808
Pneumonia 440.75 9.86 2008 437669 658238 78646473
Muscle injury 422.24 9.86 869 438808 47692 79257019
Aspirin-exacerbated respiratory disease 416.96 9.86 179 439498 1028 79303683
Lip oedema 411.43 9.86 314 439363 6002 79298709
Duodenal ulcer perforation 411.23 9.86 1037 438640 65174 79239537
Haematemesis 410.16 9.86 897 438780 51367 79253344
Abdominal pain upper 401.74 9.86 2354 437323 221465 79083246
Irritable bowel syndrome 390.92 9.86 979 438698 61262 79243449
Tubulointerstitial nephritis 389.08 9.86 731 438946 37504 79267207
Folliculitis 361.44 9.86 884 438793 54496 79250215
Overdose 349.85 9.86 1967 437710 182239 79122472
Sleep disorder due to general medical condition, insomnia type 329.85 9.86 737 438940 42819 79261892
Interstitial lung disease 326.00 9.86 107 439570 112493 79192218
Helicobacter infection 311.83 9.86 969 438708 68735 79235976
Neutropenia 308.84 9.86 707 438970 287003 79017708
Melaena 303.10 9.86 879 438798 60011 79244700
Blister 298.38 9.86 1378 438299 118098 79186613
Completed suicide 291.79 9.86 2335 437342 243432 79061279
Emotional distress 272.58 9.86 649 439028 39320 79265391
Gastric ulcer 270.65 9.86 586 439091 33319 79271392
Cardiac failure 263.07 9.86 279 439398 154563 79150148
Renal tubular acidosis 249.43 9.86 186 439491 3428 79301283
Uterine perforation 241.35 9.86 231 439446 6072 79298639
Impaired healing 238.36 9.86 1037 438640 86618 79218093
Toxicity to various agents 234.44 9.86 3440 436237 418100 78886611
Duodenal ulcer 233.95 9.86 364 439313 16005 79288706
Platelet count decreased 228.25 9.86 455 439222 194209 79110502
Pruritus 224.33 9.86 3233 436444 391415 78913296
Cardiac failure congestive 217.77 9.86 279 439398 142123 79162588
Metabolic acidosis 215.78 9.86 965 438712 81564 79223147
Upper gastrointestinal haemorrhage 214.30 9.86 606 439071 40774 79263937
Pain 213.48 9.86 5230 434447 698572 78606139
Thrombocytopenia 207.57 9.86 757 438920 264502 79040209
Lower respiratory tract infection 206.87 9.86 1320 438357 127900 79176811
Sepsis 203.59 9.86 780 438897 268648 79036063
Acute kidney injury 202.21 9.86 4001 435676 515403 78789308
Face oedema 201.80 9.86 466 439211 27670 79277041
Malignant neoplasm progression 200.22 9.86 274 439403 135716 79168995
Disease progression 195.31 9.86 456 439221 183906 79120805
Hypersensitivity 194.72 9.86 2257 437420 259982 79044729
Discomfort 188.77 9.86 1263 438414 124354 79180357
Gastric ulcer perforation 184.48 9.86 126 439551 2009 79302702
Eyelid oedema 179.98 9.86 293 439384 13394 79291317
Sinusitis 178.41 9.86 1754 437923 193747 79110964
Drug resistance 173.96 9.86 16 439661 42197 79262514
Stevens-Johnson syndrome 170.08 9.86 539 439138 38627 79266084
Gastrointestinal disorder 166.70 9.86 1200 438477 121005 79183706
Meningitis aseptic 161.12 9.86 195 439482 6733 79297978
Glomerulonephritis minimal lesion 160.41 9.86 81 439596 706 79304005
Gastric haemorrhage 159.67 9.86 293 439384 14757 79289954
Joint swelling 157.27 9.86 2348 437329 286298 79018413
Gastritis 156.76 9.86 601 439076 47392 79257319
Pericarditis 154.77 9.86 1045 438632 103191 79201520
Pancytopenia 154.72 9.86 437 439240 165308 79139403
Gallbladder disorder 150.62 9.86 331 439346 19009 79285702
Wound closure 149.78 9.86 50 439627 120 79304591
Gastrointestinal haemorrhage 149.53 9.86 1355 438322 146364 79158347
Anaphylactic reaction 144.99 9.86 873 438804 82870 79221841
Anti-cyclic citrullinated peptide antibody positive 144.75 9.86 868 438809 82275 79222436
Fall 144.44 9.86 1859 437818 485770 78818941
Cytomegalovirus infection 143.40 9.86 30 439647 42614 79262097
Fixed eruption 141.98 9.86 123 439554 2831 79301880
Peritonsillar abscess 139.77 9.86 78 439599 848 79303863
Intentional self-injury 133.38 9.86 438 439239 31981 79272730
Biliary dyskinesia 132.61 9.86 111 439566 2434 79302277
Toxic epidermal necrolysis 132.48 9.86 542 439135 44039 79260672
Vomiting 131.32 9.86 4691 434986 661137 78643574
Ear pain 129.83 9.86 438 439239 32431 79272280
Osteotomy 129.81 9.86 51 439626 224 79304487
Swelling 124.33 9.86 1779 437898 214932 79089779
Muscle spasticity 122.62 9.86 326 439351 21149 79283562
Ill-defined disorder 122.61 9.86 700 438977 65175 79239536
Duodenal ulcer haemorrhage 122.06 9.86 173 439504 6990 79297721
Ascites 121.86 9.86 142 439535 75420 79229291
Atrial fibrillation 120.33 9.86 621 439056 197265 79107446
Palatal oedema 117.87 9.86 82 439595 1349 79303362
Gastritis erosive 117.38 9.86 213 439464 10634 79294077
Rheumatoid arthritis 117.07 9.86 1705 437972 206765 79097946
Psoriatic arthropathy 115.19 9.86 781 438896 77218 79227493
Glossodynia 113.41 9.86 965 438712 102372 79202339
Enthesopathy 111.98 9.86 217 439460 11391 79293320
Septic shock 110.77 9.86 329 439348 122472 79182239
Night sweats 110.04 9.86 573 439104 51522 79253189
Fluid retention 107.48 9.86 136 439541 69673 79235038
Analgesic drug level increased 105.95 9.86 108 439569 3070 79301641
Lip swelling 105.87 9.86 477 439200 40434 79264277
Neutrophil count decreased 105.50 9.86 225 439452 93734 79210977
Respiratory failure 105.38 9.86 576 439101 180335 79124376
Myocardial infarction 105.21 9.86 590 439087 183539 79121172
Kounis syndrome 101.99 9.86 122 439555 4160 79300551
White blood cell count decreased 100.83 9.86 616 439061 187672 79117039
Pemphigus 100.50 9.86 913 438764 98669 79206042
Hospitalisation 99.81 9.86 233 439444 94003 79210708
Ankylosing spondylitis 99.74 9.86 213 439464 11992 79292719
Self-medication 99.60 9.86 132 439545 5000 79299711
Hypervolaemia 99.01 9.86 56 439621 42634 79262077
Plasma cell myeloma 98.45 9.86 89 439588 53170 79251541
Stomatitis 98.27 9.86 1239 438438 145518 79159193
Neuropathy peripheral 97.89 9.86 423 439254 140882 79163829
Bone marrow failure 97.38 9.86 83 439594 51024 79253687
Anaemia 96.20 9.86 1801 437876 443214 78861497
Renal papillary necrosis 95.76 9.86 47 439630 383 79304328
Orthostatic hypotension 95.56 9.86 101 439576 56063 79248648
Chronic obstructive pulmonary disease 95.53 9.86 205 439472 85214 79219497
Foreign body in throat 93.85 9.86 48 439629 431 79304280
Arthropathy 92.97 9.86 1432 438245 175679 79129032
Hypomagnesaemia 92.08 9.86 74 439603 46837 79257874
Clostridium difficile infection 92.02 9.86 61 439616 42624 79262087
Tenosynovitis 91.74 9.86 239 439438 15315 79289396
Synovitis 90.68 9.86 1248 438429 149486 79155225
Tongue oedema 89.06 9.86 149 439528 6968 79297743
Rash 88.97 9.86 3968 435709 574390 78730321
Glomerulonephritis membranous 87.36 9.86 72 439605 1544 79303167
Hepatic function abnormal 86.38 9.86 170 439507 72937 79231774
Hand deformity 85.94 9.86 914 438763 103005 79201706
Peripheral swelling 85.36 9.86 2017 437660 267600 79037111
Diarrhoea 85.08 9.86 3979 435698 876510 78428201
Therapeutic product effect decreased 83.76 9.86 1319 438358 162544 79142167
Wrong technique in product usage process 83.69 9.86 176 439501 73699 79231012
Myelosuppression 83.66 9.86 60 439617 40236 79264475
Hyponatraemia 83.58 9.86 605 439072 177243 79127468
Tongue disorder 82.70 9.86 215 439462 13760 79290951
Nasopharyngitis 81.51 9.86 1903 437774 251978 79052733
Acute hepatic failure 80.85 9.86 355 439322 29758 79274953
Product prescribing error 80.65 9.86 472 439205 44341 79260370
Pleural effusion 80.52 9.86 470 439207 144792 79159919
Pulmonary arterial hypertension 80.25 9.86 28 439649 28338 79276373
Acute generalised exanthematous pustulosis 80.04 9.86 243 439434 17011 79287700
Oxygen saturation decreased 79.53 9.86 403 439274 128644 79176067
Brain empyema 78.91 9.86 20 439657 6 79304705
Transplant rejection 78.42 9.86 8 439669 19429 79285282
Pulmonary hypertension 77.90 9.86 90 439587 47990 79256721
Pneumocystis jirovecii pneumonia 77.78 9.86 41 439636 32467 79272244
Intestinal diaphragm disease 77.18 9.86 38 439639 312 79304399
Blood pressure increased 76.87 9.86 769 438908 210591 79094120
Tendonitis 76.65 9.86 297 439380 23533 79281178
Periorbital oedema 76.14 9.86 153 439524 8249 79296462
Peptic ulcer 74.84 9.86 128 439549 6095 79298616
Gastric ulcer haemorrhage 74.30 9.86 158 439519 8869 79295842
Musculoskeletal stiffness 74.27 9.86 1367 438310 173641 79131070
Suspected suicide 73.46 9.86 173 439504 10403 79294308
Abdominal discomfort 70.80 9.86 1847 437830 248880 79055831
Haematochezia 68.37 9.86 762 438915 86883 79217828
Acute myeloid leukaemia 68.13 9.86 43 439634 30842 79273869
Systemic lupus erythematosus 68.01 9.86 991 438686 120158 79184553
Cytokine release syndrome 67.93 9.86 59 439618 35939 79268772
Diabetes mellitus 67.84 9.86 214 439463 78176 79226535
Anxiety 66.81 9.86 1819 437858 246693 79058018
Wound 66.67 9.86 954 438723 115225 79189486
Bezoar 66.36 9.86 78 439599 2610 79302101
Deep vein thrombosis 66.26 9.86 985 438692 119934 79184777
Renal impairment 66.06 9.86 554 439123 157229 79147482
Abdominal pain lower 66.03 9.86 348 439329 31434 79273277
Contraindicated product administered 65.95 9.86 1228 438449 156310 79148401
Vanishing bile duct syndrome 65.88 9.86 64 439613 1714 79302997
Myelodysplastic syndrome 65.73 9.86 43 439634 30258 79274453
Arthralgia 65.66 9.86 3815 435862 567988 78736723
Medication error 65.55 9.86 622 439055 68020 79236691
Hypoaldosteronism 65.13 9.86 35 439642 351 79304360
Gastrointestinal pain 65.00 9.86 158 439519 9697 79295014
Bronchopulmonary aspergillosis 64.82 9.86 21 439656 22273 79282438
Herpes zoster 64.23 9.86 279 439398 92804 79211907
Red blood cell sedimentation rate abnormal 64.12 9.86 18 439659 20945 79283766
Intentional product misuse 63.91 9.86 804 438873 94361 79210350
Graft versus host disease 63.82 9.86 5 439672 15021 79289690
Cholelithiasis 63.79 9.86 503 439174 52161 79252550
Deafness transitory 63.78 9.86 49 439628 946 79303765
Infection 63.50 9.86 1764 437913 239948 79064763
Medication overuse headache 63.08 9.86 47 439630 865 79303846
Neurotoxicity 62.95 9.86 52 439625 32466 79272245
Nasal disorder 62.71 9.86 90 439587 3679 79301032
Mucosal inflammation 62.17 9.86 211 439466 75369 79229342
Hypoxia 62.15 9.86 325 439352 102918 79201793
Pneumonia aspiration 62.13 9.86 177 439500 66790 79237921
Hepatic enzyme increased 61.75 9.86 1379 438298 181231 79123480
Liver injury 61.73 9.86 528 439149 56086 79248625
Haemoglobin decreased 61.53 9.86 858 438819 221261 79083450
Hypoglycaemia 61.05 9.86 320 439357 101274 79203437
Gallbladder injury 61.04 9.86 52 439625 1169 79303542
Bradycardia 60.87 9.86 467 439210 135090 79169621
Blood glucose increased 60.04 9.86 379 439298 114596 79190115
Respiratory disorder 59.70 9.86 438 439239 44418 79260293
Full blood count abnormal 59.09 9.86 82 439595 40392 79264319
Sleep disorder 58.89 9.86 727 438950 84950 79219761
Heart rate decreased 57.36 9.86 197 439480 70119 79234592
Cardiac disorder 56.55 9.86 180 439497 65577 79239134
Cytopenia 56.17 9.86 21 439656 20362 79284349
Tumour lysis syndrome 56.09 9.86 31 439646 23908 79280803
Oesophageal obstruction 56.06 9.86 46 439631 980 79303731
Lemierre syndrome 55.88 9.86 24 439653 138 79304573
Cytomegalovirus viraemia 55.21 9.86 4 439673 12817 79291894
Constipation 55.20 9.86 1165 438512 281885 79022826
Pharyngeal abscess 55.07 9.86 39 439638 661 79304050
Anhedonia 54.03 9.86 193 439484 14705 79290006
Headache 53.43 9.86 4240 435437 649532 78655179
Urinary tract infection 52.90 9.86 1132 438545 273380 79031331
Product use in unapproved indication 52.83 9.86 1017 438660 249342 79055369
Right ventricular failure 52.82 9.86 32 439645 23465 79281246
Osteoporosis 52.45 9.86 140 439537 53972 79250739
Leukopenia 52.03 9.86 402 439275 116111 79188600
Haematotoxicity 52.01 9.86 11 439666 15508 79289203
Device related infection 51.56 9.86 68 439609 34226 79270485
Red blood cell count decreased 51.18 9.86 155 439522 57358 79247353
Post transplant lymphoproliferative disorder 51.07 9.86 3 439674 11461 79293250
Dyspnoea exertional 50.80 9.86 277 439400 86796 79217915
Renal cortical necrosis 50.76 9.86 29 439648 331 79304380
Cerebral infarction 50.75 9.86 110 439567 45566 79259145
Drug ineffective 50.46 9.86 5206 434471 1075707 78229004
Multiple organ dysfunction syndrome 50.41 9.86 422 439255 119824 79184887
Obstructive airways disorder 49.77 9.86 60 439617 31399 79273312
Bronchiectasis 49.61 9.86 31 439646 22355 79282356
Hypotension 49.38 9.86 1956 437721 438361 78866350
Faeces discoloured 49.34 9.86 302 439375 28825 79275886
Bronchitis 48.87 9.86 472 439205 130172 79174539
Abdominal pain 48.70 9.86 2620 437057 386949 78917762
Pathogen resistance 48.40 9.86 10 439667 14332 79290379
Body temperature increased 48.28 9.86 414 439263 44006 79260705
Dementia 48.27 9.86 39 439638 24620 79280091
Mucocutaneous disorder 47.75 9.86 21 439656 129 79304582
Encephalopathy 47.73 9.86 200 439477 67197 79237514
Red blood cell sedimentation rate 47.66 9.86 99 439578 5466 79299245
Productive cough 46.20 9.86 291 439386 88040 79216671
Heavy menstrual bleeding 46.19 9.86 176 439501 13835 79290876
Bladder cancer 46.16 9.86 25 439652 19501 79285210
IgM nephropathy 46.14 9.86 20 439657 118 79304593
Posterior reversible encephalopathy syndrome 46.13 9.86 46 439631 26235 79278476
Aspergillus infection 46.08 9.86 24 439653 19137 79285574
Systemic lupus erythematosus rash 45.96 9.86 54 439623 1806 79302905
Cross sensitivity reaction 45.50 9.86 77 439600 3635 79301076
Intestinal obstruction 45.04 9.86 107 439570 42913 79261798
Kidney transplant rejection 44.69 9.86 3 439674 10243 79294468
Laryngeal dyspnoea 44.47 9.86 25 439652 276 79304435
Swelling face 44.18 9.86 593 439084 70619 79234092
Blood pressure fluctuation 44.07 9.86 205 439472 66940 79237771
C-reactive protein abnormal 44.07 9.86 434 439243 47933 79256778
Frequent bowel movements 43.97 9.86 59 439618 29480 79275231
Cardiac failure acute 43.65 9.86 25 439652 18904 79285807
Serotonin syndrome 43.26 9.86 117 439560 44910 79259801
Neuroleptic malignant syndrome 43.14 9.86 53 439624 27506 79277205
Product dose omission issue 43.09 9.86 1037 438640 246500 79058211
Pulmonary oedema 43.01 9.86 297 439380 87957 79216754
Eye swelling 42.69 9.86 271 439406 26197 79278514
Ventricular tachycardia 42.56 9.86 106 439571 41829 79262882
Contusion 42.54 9.86 1098 438579 147678 79157033
Cardiogenic shock 42.50 9.86 106 439571 41808 79262903
Blood pressure decreased 42.18 9.86 348 439329 99118 79205593
Diffuse large B-cell lymphoma 41.99 9.86 8 439669 12141 79292570
Musculoskeletal disorder 41.94 9.86 231 439446 21217 79283494
Medical device discomfort 41.82 9.86 50 439627 1704 79303007
Metastases to liver 41.69 9.86 57 439620 28257 79276454
Malaise 41.65 9.86 2242 437435 487627 78817084
Type IV hypersensitivity reaction 41.47 9.86 78 439599 4003 79300708
Coronavirus infection 40.98 9.86 112 439565 7385 79297326
Lung neoplasm malignant 40.87 9.86 56 439621 27736 79276975
Toxic shock syndrome streptococcal 40.87 9.86 18 439659 111 79304600
Rheumatoid nodule 40.47 9.86 197 439480 17241 79287470
Sedation complication 40.16 9.86 18 439659 15651 79289060
Premature delivery 40.14 9.86 42 439635 23425 79281286
Product used for unknown indication 40.12 9.86 46 439631 1498 79303213
Drug interaction 39.95 9.86 1876 437801 413307 78891404
Progressive multifocal leukoencephalopathy 39.80 9.86 33 439644 20567 79284144
Embedded device 39.56 9.86 68 439609 3251 79301460
Ulcer 39.50 9.86 292 439385 29680 79275031
Torsade de pointes 38.48 9.86 30 439647 19282 79285429
Electrocardiogram QT prolonged 38.43 9.86 316 439361 90070 79214641
Pelvic pain 38.42 9.86 161 439516 13220 79291491
Conjunctival hyperaemia 38.37 9.86 79 439598 4334 79300377
Dermo-hypodermitis 38.26 9.86 33 439644 755 79303956
General physical health deterioration 38.23 9.86 1870 437807 273368 79031343
Cerebrovascular accident 38.11 9.86 614 439063 154678 79150033
Allergic respiratory disease 37.92 9.86 17 439660 110 79304601
COVID-19 37.84 9.86 626 439051 157048 79147663
Nipple swelling 37.76 9.86 23 439654 298 79304413
Flank pain 37.66 9.86 212 439465 19632 79285079
Alanine aminotransferase abnormal 37.55 9.86 121 439556 8746 79295965
Hypocalcaemia 37.34 9.86 145 439532 49779 79254932
Creatinine renal clearance decreased 37.26 9.86 30 439647 18972 79285739
Psychotic disorder 37.26 9.86 111 439566 41291 79263420
Erythema multiforme 37.16 9.86 194 439483 17457 79287254
Parkinsonism 36.70 9.86 23 439654 16561 79288150
Transfusion 36.68 9.86 38 439639 21292 79283419
Febrile bone marrow aplasia 36.58 9.86 13 439664 13007 79291704
Blood creatine phosphokinase increased 36.52 9.86 214 439463 65876 79238835
Clostridium difficile colitis 36.48 9.86 77 439600 32206 79272505
Facet joint syndrome 36.46 9.86 141 439536 11161 79293550
Cystitis haemorrhagic 36.43 9.86 4 439673 9168 79295543
Colorectal cancer 36.38 9.86 3 439674 8644 79296067
Blood pressure systolic increased 35.90 9.86 219 439458 66767 79237944
Pain in jaw 35.84 9.86 132 439545 46019 79258692
Dehydration 35.55 9.86 1069 438608 247118 79057593
Cataract 35.48 9.86 199 439478 61921 79242790
Alopecia 35.36 9.86 1587 438090 229768 79074943
Femur fracture 35.24 9.86 103 439574 38549 79266162
Beta haemolytic streptococcal infection 34.78 9.86 50 439627 2047 79302664
Pericardial effusion 34.77 9.86 134 439543 46103 79258608
Pneumonitis 34.74 9.86 195 439482 60665 79244046
Cough 34.35 9.86 1662 438015 365127 78939584
Lip dry 34.23 9.86 172 439505 15246 79289465
Jejunal ulcer 34.09 9.86 19 439658 206 79304505
Tropical infectious disease 34.04 9.86 12 439665 36 79304675
Prostate cancer 33.83 9.86 84 439593 33184 79271527
Pneumonia fungal 33.60 9.86 10 439667 11200 79293511
Biliary colic 33.37 9.86 70 439607 3892 79300819
Hypertensive emergency 33.12 9.86 57 439620 2728 79301983
Hyperkalaemia 33.06 9.86 438 439239 113960 79190751
Oesophageal carcinoma 33.01 9.86 10 439667 11074 79293637
Cerebral haemorrhage 32.80 9.86 185 439492 57488 79247223
Hunger 32.62 9.86 84 439593 5344 79299367
Drug-induced liver injury 32.54 9.86 529 439148 65588 79239123
Hepatitis B 32.18 9.86 4 439673 8328 79296383
Aplasia pure red cell 32.07 9.86 3 439674 7807 79296904
Immunodeficiency 31.87 9.86 44 439633 21724 79282987
Bacteraemia 31.75 9.86 85 439592 32739 79271972
Cytomegalovirus infection reactivation 31.74 9.86 5 439672 8711 79296000
Head discomfort 31.65 9.86 161 439516 14341 79290370
Adjustment disorder with depressed mood 31.50 9.86 116 439561 8970 79295741
Metastases to bone 31.34 9.86 54 439623 24373 79280338
Oedema peripheral 31.29 9.86 1107 438570 251181 79053530
Blood magnesium decreased 31.23 9.86 27 439650 16485 79288226
Jejunal ulcer perforation 31.22 9.86 15 439662 116 79304595
Multiple sclerosis relapse 31.17 9.86 393 439284 46140 79258571
Respiratory tract infection 31.16 9.86 150 439527 48539 79256172
Extrapyramidal disorder 31.09 9.86 48 439629 22631 79282080
Hepatocellular carcinoma 31.05 9.86 6 439671 9015 79295696
Genital haemorrhage 30.82 9.86 90 439587 6165 79298546
Throat tightness 30.80 9.86 261 439416 27646 79277065
Diabetes mellitus inadequate control 30.80 9.86 54 439623 24210 79280501
Nasal obstruction 30.75 9.86 48 439629 2116 79302595
Rales 30.75 9.86 39 439638 19962 79284749
Autoimmune disorder 30.55 9.86 176 439501 16436 79288275
Obstruction gastric 30.53 9.86 43 439634 1727 79302984
Bone erosion 30.46 9.86 32 439645 17815 79286896
Therapy interrupted 30.44 9.86 81 439596 31260 79273451
Hyperglycaemia 30.31 9.86 245 439432 70090 79234621
Hypogammaglobulinaemia 30.01 9.86 17 439660 12934 79291777
Renal cancer 29.87 9.86 15 439662 12211 79292500
Cardiac failure chronic 29.81 9.86 12 439665 11123 79293588
Catatonia 29.77 9.86 6 439671 8750 79295961
Medical device pain 29.63 9.86 38 439639 1393 79303318
Congestive cardiomyopathy 29.47 9.86 14 439663 11766 79292945
Coma scale abnormal 29.42 9.86 110 439567 8568 79296143
SJS-TEN overlap 29.41 9.86 28 439649 731 79303980
Poisoning 29.30 9.86 239 439438 25033 79279678
Gallbladder cholesterolosis 29.25 9.86 26 439651 620 79304091
Renal tubular necrosis 29.14 9.86 237 439440 24802 79279909
Gastric perforation 29.09 9.86 67 439610 3970 79300741
Unintentional medical device removal 29.07 9.86 4 439673 7708 79297003
Blood parathyroid hormone decreased 28.88 9.86 125 439552 10411 79294300
International normalised ratio increased 28.83 9.86 313 439364 84408 79220303
Myoclonus 28.79 9.86 69 439608 27591 79277120
Duodenitis 28.71 9.86 103 439574 7864 79296847
Discoloured vomit 28.66 9.86 38 439639 1440 79303271
Corneal leukoma 28.66 9.86 8 439669 7 79304704
Full blood count decreased 28.64 9.86 66 439611 26753 79277958
Neutropenic sepsis 28.58 9.86 67 439610 26997 79277714
Epilepsy 28.47 9.86 122 439555 40738 79263973
Abnormal clotting factor 28.43 9.86 16 439661 177 79304534
Hepatic cirrhosis 28.33 9.86 98 439579 34808 79269903
Unevaluable event 28.11 9.86 185 439492 55400 79249311
Atrioventricular block complete 28.10 9.86 30 439647 16580 79288131
Candida infection 27.93 9.86 112 439565 38102 79266609
Pulmonary infarction 27.87 9.86 64 439613 3785 79300926
Depression 27.84 9.86 1462 438215 215328 79089383
Peritonitis bacterial 27.84 9.86 9 439668 9558 79295153
Cognitive disorder 27.70 9.86 249 439428 69677 79235034
Urosepsis 27.65 9.86 66 439611 26429 79278282
Serum sickness-like reaction 27.65 9.86 25 439652 610 79304101
Blood cholesterol increased 27.58 9.86 630 439047 83090 79221621
Hemiplegia 27.56 9.86 25 439652 14914 79289797
Diabetic ketoacidosis 27.55 9.86 96 439581 34026 79270685
Laryngeal oedema 27.53 9.86 103 439574 8026 79296685
Sleep disorder due to a general medical condition 27.42 9.86 23 439654 14254 79290457
Aplasia 27.35 9.86 5 439672 7815 79296896
Acute pulmonary oedema 27.24 9.86 23 439654 14207 79290504
Hepatic cancer 27.14 9.86 12 439665 10517 79294194
Open globe injury 26.98 9.86 12 439665 76 79304635
Underdose 26.95 9.86 93 439584 33058 79271653
Meningitis pneumococcal 26.92 9.86 22 439655 466 79304245
Dyskinesia 26.90 9.86 141 439536 44632 79260079
Ischaemic stroke 26.90 9.86 93 439584 33038 79271673
Laryngeal discomfort 26.87 9.86 24 439653 576 79304135
Skin cancer 26.77 9.86 26 439651 15014 79289697
Inappropriate schedule of product administration 26.60 9.86 548 439129 133080 79171631
Conjunctivitis 26.56 9.86 237 439440 25478 79279233
Second primary malignancy 26.49 9.86 24 439653 14326 79290385
Systemic candida 26.44 9.86 3 439674 6703 79298008
Thrombotic microangiopathy 26.41 9.86 44 439633 20125 79284586
Breast cancer stage I 26.41 9.86 3 439674 6697 79298014
Metastases to lung 26.31 9.86 37 439640 18126 79286585
Peptic ulcer perforation 26.21 9.86 21 439656 432 79304279
COVID-19 pneumonia 26.21 9.86 77 439600 28772 79275939
Drug ineffective for unapproved indication 26.18 9.86 170 439507 51068 79253643
Erosive duodenitis 26.06 9.86 44 439633 2073 79302638
Granuloma skin 26.04 9.86 110 439567 9064 79295647
Epistaxis 26.01 9.86 445 439232 111070 79193641
Rheumatic fever 26.01 9.86 256 439421 28269 79276442
Photophobia 25.93 9.86 198 439479 20330 79284381
Hip fracture 25.89 9.86 85 439592 30676 79274035
Escherichia infection 25.80 9.86 37 439640 17980 79286731
Hypothermia 25.78 9.86 214 439463 22532 79282179
Foreign body in gastrointestinal tract 25.65 9.86 11 439666 63 79304648
Sacroiliitis 25.63 9.86 61 439616 3693 79301018
Gastric cancer 25.61 9.86 12 439665 10167 79294544
Staphylococcal infection 25.61 9.86 202 439475 58093 79246618
Fear of injection 25.56 9.86 95 439582 7379 79297332
Grip strength decreased 25.46 9.86 207 439470 21662 79283049
Stress cardiomyopathy 25.39 9.86 15 439662 11151 79293560
Acute respiratory failure 25.38 9.86 208 439469 59333 79245378
Panniculitis 25.38 9.86 135 439542 12236 79292475
Weight decreased 25.27 9.86 1653 438024 353545 78951166
Genital odour 25.24 9.86 6 439671 0 79304711
Pseudomonas infection 25.21 9.86 48 439629 20855 79283856
Cholesterosis 25.17 9.86 19 439658 357 79304354
Toxic encephalopathy 25.13 9.86 16 439661 11424 79293287
Tendon disorder 25.13 9.86 92 439585 7094 79297617
Subdural haematoma 25.01 9.86 89 439588 31345 79273366
Gastritis haemorrhagic 24.81 9.86 49 439628 2608 79302103
Disease recurrence 24.81 9.86 142 439535 43967 79260744
Nipple pain 24.76 9.86 28 439649 898 79303813
Breath sounds abnormal 24.74 9.86 31 439646 15953 79288758
Balance disorder 24.53 9.86 390 439287 98467 79206244
Haemorrhage intracranial 24.46 9.86 69 439608 26124 79278587
Cardiotoxicity 24.40 9.86 19 439658 12220 79292491
Hepatitis acute 24.37 9.86 158 439519 15384 79289327
Glycosylated haemoglobin increased 24.32 9.86 43 439634 19217 79285494
Distichiasis 24.32 9.86 8 439669 18 79304693
Necrotising fasciitis 24.22 9.86 81 439596 5969 79298742
Device leakage 24.10 9.86 15 439662 10841 79293870
Atrial flutter 24.09 9.86 52 439625 21573 79283138
Acute lung injury 24.07 9.86 53 439624 3047 79301664
Coma 24.04 9.86 726 438951 99923 79204788
Deep vein thrombosis postoperative 23.91 9.86 120 439557 10632 79294079
Exposure to toxic agent 23.85 9.86 107 439570 9051 79295660
Blood glucose decreased 23.85 9.86 70 439607 26164 79278547
Milk-alkali syndrome 23.76 9.86 34 439643 1386 79303325
Cholecystectomy 23.67 9.86 109 439568 9323 79295388
Insomnia 23.48 9.86 1611 438066 243559 79061152
Pregnancy with contraceptive device 23.48 9.86 58 439619 3596 79301115
Dystonia 23.39 9.86 52 439625 21347 79283364
Blood phosphorus increased 23.38 9.86 14 439663 10333 79294378
Multiple sclerosis 23.34 9.86 206 439471 22076 79282635
Pulmonary mass 23.23 9.86 82 439595 28952 79275759
Disseminated intravascular coagulation 23.18 9.86 110 439567 35732 79268979
Back pain 23.18 9.86 1963 437714 302217 79002494
Eosinophilic oesophagitis 23.18 9.86 22 439655 572 79304139
Cushingoid 22.92 9.86 12 439665 9540 79295171
Muscle rigidity 22.82 9.86 47 439630 19835 79284876
Hypothyroidism 22.80 9.86 182 439495 52210 79252501
Malnutrition 22.74 9.86 57 439620 22445 79282266
Pneumonia viral 22.73 9.86 11 439666 9147 79295564
Dental operation 22.72 9.86 30 439647 1132 79303579
Pancreatic carcinoma 22.44 9.86 25 439652 13552 79291159
Glaucoma 22.44 9.86 47 439630 19714 79284997
Staphylococcal sepsis 22.34 9.86 29 439648 14697 79290014
Helicobacter test positive 22.33 9.86 32 439645 1306 79303405
Cerebral venous sinus thrombosis 22.31 9.86 43 439634 2248 79302463
Tremor 22.31 9.86 741 438936 169342 79135369
Anti-cyclic citrullinated peptide antibody 22.24 9.86 77 439600 5775 79298936
Infertility female 22.20 9.86 19 439658 430 79304281
Tonsillar erythema 22.17 9.86 7 439670 13 79304698
Peripheral venous disease 22.12 9.86 157 439520 15752 79288959
Erosive oesophagitis 22.07 9.86 49 439628 2833 79301878
Genital tract inflammation 21.98 9.86 9 439668 45 79304666
Pelvic venous thrombosis 21.96 9.86 42 439635 2183 79302528
Device malfunction 21.93 9.86 54 439623 21394 79283317
Nodule 21.90 9.86 60 439617 22934 79281777
Pharyngeal erythema 21.86 9.86 40 439637 2010 79302701
Maternal exposure timing unspecified 21.83 9.86 76 439601 5716 79298995
Adrenal insufficiency 21.78 9.86 82 439595 28405 79276306
Device occlusion 21.72 9.86 20 439657 11846 79292865
Myopathy 21.64 9.86 51 439626 20512 79284199
Pulmonary alveolar haemorrhage 21.35 9.86 19 439658 11438 79293273
Nocardiosis 21.28 9.86 3 439674 5676 79299035
Psychological trauma 21.12 9.86 32 439645 1374 79303337
Pneumonia bacterial 21.11 9.86 47 439630 19284 79285427
Thyroid disorder 21.08 9.86 28 439649 14051 79290660
Functional gastrointestinal disorder 21.05 9.86 68 439609 4922 79299789
Swollen joint count increased 21.02 9.86 206 439471 22721 79281990
Coeliac disease 20.94 9.86 19 439658 11332 79293379
Dyspareunia 20.90 9.86 38 439639 1900 79302811
Migraine 20.87 9.86 631 439046 86862 79217849
Gallbladder hypofunction 20.85 9.86 20 439657 527 79304184
Bunion operation 20.85 9.86 26 439651 926 79303785
Coronary arterial stent insertion 20.85 9.86 4 439673 6040 79298671
Poor venous access 20.75 9.86 43 439634 18106 79286605
Internal injury 20.73 9.86 17 439660 362 79304349
Macular degeneration 20.73 9.86 19 439658 11277 79293434
Joint injury 20.71 9.86 264 439413 31071 79273640
Injection site pain 20.67 9.86 551 439126 129287 79175424
Endophthalmitis 20.65 9.86 5 439672 6423 79298288
Head injury 20.64 9.86 121 439556 37248 79267463
Paraesthesia 20.64 9.86 1179 438498 175144 79129567
Scar 20.57 9.86 149 439528 15047 79289664
Pneumatosis intestinalis 20.50 9.86 5 439672 6392 79298319
Uterine leiomyoma 20.47 9.86 80 439597 6363 79298348
Peripheral sensory neuropathy 20.47 9.86 25 439652 13008 79291703
Nephrolithiasis 20.44 9.86 410 439267 52881 79251830
Ductus arteriosus stenosis foetal 20.43 9.86 10 439667 81 79304630
Therapeutic product effect incomplete 20.29 9.86 610 439067 141035 79163676
Epiglottic oedema 20.27 9.86 16 439661 322 79304389
Mallory-Weiss syndrome 20.19 9.86 47 439630 2805 79301906
Neoplasm progression 20.05 9.86 185 439492 51497 79253214
Asphyxia 20.02 9.86 21 439656 11699 79293012
Shoulder arthroplasty 19.94 9.86 51 439626 3231 79301480
Schizophrenia 19.93 9.86 34 439643 15406 79289305
Temperature regulation disorder 19.92 9.86 4 439673 5849 79298862
Ceruloplasmin decreased 19.85 9.86 7 439670 21 79304690
Rash maculo-papular 19.73 9.86 426 439251 55652 79249059
Dislocation of vertebra 19.73 9.86 91 439586 7789 79296922
Intervertebral disc disorder 19.67 9.86 65 439612 4760 79299951
Staphylococcal bacteraemia 19.65 9.86 23 439654 12195 79292516
Colitis 19.63 9.86 285 439392 73022 79231689
Inflammation 19.46 9.86 665 439012 93088 79211623
Blood potassium increased 19.43 9.86 89 439588 29186 79275525
Drug level decreased 19.25 9.86 31 439646 14371 79290340
Hypoaesthesia 19.24 9.86 1190 438487 178162 79126549
Chromaturia 19.24 9.86 222 439455 25524 79279187
Rhabdomyolysis 19.05 9.86 428 439249 102703 79202008
Oesophagitis haemorrhagic 19.03 9.86 21 439656 655 79304056
Leukoencephalopathy 18.97 9.86 10 439667 7919 79296792
Nerve injury 18.93 9.86 102 439575 9290 79295421
Foot operation 18.88 9.86 72 439605 5661 79299050
Large intestine perforation 18.87 9.86 32 439645 14535 79290176
Acidosis 18.82 9.86 179 439498 19583 79285128
Cardiomyopathy 18.79 9.86 88 439589 28686 79276025
Lymphoproliferative disorder 18.77 9.86 4 439673 5611 79299100
Perforated ulcer 18.76 9.86 21 439656 666 79304045
Prepyloric stenosis 18.70 9.86 5 439672 3 79304708
Viral parotitis 18.70 9.86 5 439672 3 79304708
Pulmonary tuberculosis 18.70 9.86 10 439667 7855 79296856
Enterocolitis 18.69 9.86 32 439645 14480 79290231
Blood calcium decreased 18.68 9.86 101 439576 31718 79272993
Oesophageal oedema 18.63 9.86 8 439669 46 79304665
Type I hypersensitivity 18.61 9.86 60 439617 4338 79300373
Duodenal ulcer repair 18.58 9.86 9 439668 71 79304640
Cervicobrachial syndrome 18.53 9.86 27 439650 1119 79303592
Lymphopenia 18.49 9.86 96 439581 30461 79274250
Hepatic necrosis 18.46 9.86 99 439578 9001 79295710
Palmar-plantar erythrodysaesthesia syndrome 18.45 9.86 107 439570 33027 79271684
Anhidrosis 18.42 9.86 13 439664 219 79304492
Ventricular fibrillation 18.38 9.86 102 439575 31824 79272887
Accidental exposure to product by child 18.33 9.86 46 439631 2880 79301831
Organising pneumonia 18.24 9.86 20 439657 10919 79293792
Haemoptysis 18.21 9.86 209 439468 55790 79248921
Sinus node dysfunction 18.00 9.86 10 439667 7691 79297020
Bacterial infection 17.97 9.86 100 439577 31180 79273531
Embolism arterial 17.96 9.86 31 439646 1487 79303224
Status epilepticus 17.92 9.86 74 439603 24967 79279744
Blood test abnormal 17.79 9.86 45 439632 17665 79287046
Pemphigoid 17.75 9.86 36 439641 15279 79289432
Pulmonary function test decreased 17.73 9.86 10 439667 7627 79297084
Hyperammonaemia 17.72 9.86 21 439656 11072 79293639
Inadequate analgesia 17.67 9.86 61 439616 4568 79300143
Purpura fulminans 17.64 9.86 12 439665 190 79304521
Selenium deficiency 17.60 9.86 7 439670 32 79304679
Needle issue 17.59 9.86 28 439649 13040 79291671
Renal disorder 17.53 9.86 148 439529 41957 79262754
Haemorrhagic erosive gastritis 17.51 9.86 21 439656 718 79303993
Cystitis 17.47 9.86 196 439481 52536 79252175
Rash pruritic 17.46 9.86 518 439159 71111 79233600
Hyperventilation 17.45 9.86 88 439589 7811 79296900
Colitis ulcerative 17.38 9.86 116 439561 34626 79270085
Klebsiella infection 17.34 9.86 38 439639 15682 79289029
Anoxia 17.29 9.86 15 439662 346 79304365
Paradoxical drug reaction 17.28 9.86 9 439668 7176 79297535
Blindness 17.27 9.86 89 439588 28294 79276417
Hyperacusis 17.26 9.86 38 439639 2185 79302526
Escherichia sepsis 17.23 9.86 13 439664 8495 79296216
Clostridium test positive 17.20 9.86 7 439670 6447 79298264
Dysmenorrhoea 17.15 9.86 46 439631 2999 79301712
Hepatitis cholestatic 17.15 9.86 133 439544 13719 79290992
Sedation 17.14 9.86 193 439484 51702 79253009
Blood pressure diastolic decreased 17.14 9.86 97 439580 30119 79274592
Pneumonia necrotising 17.14 9.86 27 439650 1200 79303511
Duodenal obstruction 17.08 9.86 16 439661 409 79304302
Fear 17.07 9.86 191 439486 21795 79282916
Ejection fraction decreased 17.02 9.86 116 439561 34461 79270250
Generalised oedema 17.01 9.86 70 439607 23639 79281072
Elbow operation 17.00 9.86 15 439662 354 79304357
Spondylitis 16.91 9.86 61 439616 4670 79300041
Injection site extravasation 16.88 9.86 17 439660 9652 79295059
Therapy partial responder 16.86 9.86 45 439632 17352 79287359
Xyphoid retraction 16.85 9.86 11 439666 162 79304549
Salivary gland cyst 16.82 9.86 4 439673 0 79304711
Shoulder injury related to vaccine administration 16.82 9.86 4 439673 0 79304711
Eosinophil count increased 16.77 9.86 44 439633 17061 79287650
Protein-losing gastroenteropathy 16.76 9.86 19 439658 611 79304100
Gastritis bacterial 16.76 9.86 15 439662 361 79304350
Injection site hyperaesthesia 16.75 9.86 8 439669 61 79304650
Female genital tract fistula 16.73 9.86 6 439671 5969 79298742
Listless 16.63 9.86 53 439624 3808 79300903
Ileus 16.63 9.86 81 439596 26130 79278581
Anion gap 16.61 9.86 37 439640 2144 79302567
Trichiasis 16.60 9.86 9 439668 92 79304619
Liver disorder 16.56 9.86 290 439387 72127 79232584
Tuberculosis 16.55 9.86 37 439640 15161 79289550
Oropharyngeal blistering 16.52 9.86 21 439656 763 79303948
Subarachnoid haemorrhage 16.47 9.86 74 439603 24391 79280320
Duodenal stenosis 16.45 9.86 21 439656 766 79303945
Infection masked 16.39 9.86 10 439667 130 79304581
Scleroderma 16.36 9.86 5 439672 5505 79299206
Enterococcal infection 16.35 9.86 39 439638 15621 79289090
Spinal compression fracture 16.34 9.86 44 439633 16914 79287797
Vaginal ulceration 16.28 9.86 13 439664 266 79304445
Oligoarthritis 16.22 9.86 20 439657 704 79304007
Burn oral cavity 16.22 9.86 8 439669 66 79304645
Gastric mucosa erythema 16.19 9.86 15 439662 378 79304333
Abdominal tenderness 16.18 9.86 107 439570 10487 79294224
Therapeutic response decreased 16.17 9.86 265 439412 66588 79238123
Allergy test positive 16.13 9.86 20 439657 708 79304003
Dermatitis bullous 16.13 9.86 134 439543 14111 79290600
Psychogenic tremor 16.12 9.86 6 439671 22 79304689
Colon cancer 16.11 9.86 35 439642 14488 79290223
Intentional product use issue 16.09 9.86 680 438997 151432 79153279
Cardiac pacemaker insertion 16.04 9.86 6 439671 5816 79298895
Spinal pain 15.97 9.86 142 439535 15250 79289461
Benign familial pemphigus 15.93 9.86 5 439672 9 79304702
Emphysema 15.92 9.86 42 439635 16258 79288453
Severe invasive streptococcal infection 15.92 9.86 7 439670 43 79304668
Nausea 15.91 9.86 5690 433987 951506 78353205
Dactylitis 15.89 9.86 42 439635 2715 79301996
Oral pruritus 15.88 9.86 39 439638 2409 79302302
Heparin-induced thrombocytopenia 15.82 9.86 18 439659 9664 79295047
Lung transplant 15.77 9.86 3 439674 4558 79300153
Vulval ulceration 15.69 9.86 12 439665 230 79304481
Hepatitis B reactivation 15.68 9.86 7 439670 6101 79298610
Immune reconstitution inflammatory syndrome 15.65 9.86 33 439644 13808 79290903
Atrial tachycardia 15.64 9.86 10 439667 7123 79297588
Musculoskeletal pain 15.59 9.86 702 438975 101652 79203059
Joint range of motion decreased 15.53 9.86 264 439413 33018 79271693
Pigment nephropathy 15.53 9.86 7 439670 46 79304665
Gastrointestinal ulcer 15.49 9.86 48 439629 3398 79301313
Platelet function test abnormal 15.45 9.86 11 439666 188 79304523
Asthenia 15.35 9.86 2533 437144 509156 78795555
Acidosis hyperchloraemic 15.34 9.86 21 439656 821 79303890
Pyrexia 15.32 9.86 3410 436267 675299 78629412
Subileus 15.29 9.86 6 439671 5648 79299063
Muscle swelling 15.28 9.86 21 439656 824 79303887
Abdominal distension 15.28 9.86 523 439154 119127 79185584
Tobacco abuse 15.26 9.86 23 439654 983 79303728
Necrosis ischaemic 15.24 9.86 24 439653 1066 79303645
Fusobacterium infection 15.22 9.86 9 439668 110 79304601
Orbital compartment syndrome 15.17 9.86 8 439669 77 79304634
Brain natriuretic peptide increased 15.14 9.86 16 439661 8884 79295827
Muscle tone disorder 15.11 9.86 10 439667 151 79304560
Neutrophil Pelger-Huet anomaly present 15.10 9.86 14 439663 353 79304358
Kidney enlargement 15.10 9.86 26 439651 1245 79303466
Food refusal 15.09 9.86 17 439660 543 79304168
Enzyme induction 15.09 9.86 9 439668 112 79304599
Nasal pruritus 15.04 9.86 17 439660 545 79304166
Jaundice 15.02 9.86 393 439284 52956 79251755
Pneumonia streptococcal 15.00 9.86 41 439636 2704 79302007
Superficial vein prominence 14.99 9.86 8 439669 79 79304632
Portal vein phlebitis 14.98 9.86 5 439672 12 79304699
Tympanic membrane hyperaemia 14.98 9.86 5 439672 12 79304699
Lymphoma 14.87 9.86 48 439629 17412 79287299
Swollen tongue 14.85 9.86 323 439354 42247 79262464
Delusion 14.84 9.86 60 439617 20363 79284348
Decreased appetite 14.80 9.86 1657 438020 340761 78963950
Oral mucosa erosion 14.80 9.86 33 439644 1914 79302797
Drug dose omission by device 14.78 9.86 8 439669 6242 79298469
Chronic sinusitis 14.78 9.86 31 439646 12995 79291716
Glomerulonephropathy 14.76 9.86 13 439664 306 79304405
Pulmonary embolism 14.72 9.86 1118 438559 170536 79134175
Hypoglycaemic coma 14.72 9.86 4 439673 4756 79299955
Blood immunoglobulin E increased 14.70 9.86 7 439670 5875 79298836
Bone loss 14.69 9.86 39 439638 2528 79302183
Infusion related reaction 14.68 9.86 1467 438210 228770 79075941
Akathisia 14.67 9.86 32 439645 13227 79291484
Complication of device removal 14.63 9.86 51 439626 3838 79300873
B-cell lymphoma 14.63 9.86 8 439669 6207 79298504
Squamous cell carcinoma of skin 14.61 9.86 35 439642 13998 79290713
Pasteurella infection 14.59 9.86 7 439670 54 79304657
Adenovirus infection 14.58 9.86 15 439662 8432 79296279
Immune effector cell-associated neurotoxicity syndrome 14.55 9.86 7 439670 5841 79298870
Urinary retention 14.52 9.86 222 439455 56408 79248303
Cerebellar syndrome 14.52 9.86 6 439671 5474 79299237
Drug withdrawal headache 14.49 9.86 8 439669 85 79304626
pH body fluid decreased 14.49 9.86 6 439671 31 79304680
Osteonecrosis 14.48 9.86 106 439571 30989 79273722
Euglycaemic diabetic ketoacidosis 14.46 9.86 10 439667 6834 79297877
Cytomegalovirus colitis 14.37 9.86 4 439673 4681 79300030
Glucose tolerance impaired 14.36 9.86 14 439663 8070 79296641
Swelling of eyelid 14.36 9.86 50 439627 3761 79300950
Mania 14.33 9.86 52 439625 18208 79286503
Transverse sinus thrombosis 14.31 9.86 18 439659 647 79304064
Chemical burn 14.30 9.86 17 439660 576 79304135
Pneumonia klebsiella 14.28 9.86 5 439672 5049 79299662
Myasthenia gravis 14.26 9.86 22 439655 10377 79294334
Allergy test negative 14.25 9.86 13 439664 321 79304390
Psoriasis 14.21 9.86 617 439060 88970 79215741
Epstein-Barr virus infection 14.19 9.86 37 439640 14379 79290332
Neck pain 14.19 9.86 529 439148 74888 79229823
Blood copper decreased 14.18 9.86 5 439672 15 79304696
Vulvovaginitis trichomonal 14.18 9.86 5 439672 15 79304696
Hallucination 14.14 9.86 362 439315 85383 79219328
Grief reaction 14.12 9.86 12 439665 269 79304442
Macrophages increased 14.12 9.86 12 439665 269 79304442
Scleroderma renal crisis 14.11 9.86 17 439660 584 79304127
Blood bilirubin unconjugated 14.07 9.86 4 439673 4 79304707
Prescribed underdose 14.04 9.86 100 439577 29414 79275297
Alveolar rhabdomyosarcoma 13.94 9.86 5 439672 16 79304695
Crepitations 13.92 9.86 21 439656 9996 79294715
Poisoning deliberate 13.91 9.86 162 439515 18666 79286045
Human papilloma virus test positive 13.88 9.86 16 439661 524 79304187
Brain death 13.80 9.86 65 439612 5612 79299099
Food craving 13.63 9.86 29 439648 1628 79303083
Meningoencephalitis bacterial 13.62 9.86 11 439666 229 79304482
Anal fistula 13.57 9.86 11 439666 6933 79297778
Glomerulonephritis acute 13.54 9.86 12 439665 285 79304426
Fear of disease 13.51 9.86 25 439652 1267 79303444
Febrile convulsion 13.47 9.86 21 439656 925 79303786
Hyperuricaemia 13.45 9.86 28 439649 11771 79292940
Angiocardiogram 13.42 9.86 11 439666 234 79304477
Joint destruction 13.41 9.86 8 439669 5917 79298794
Rash macular 13.40 9.86 229 439448 28670 79276041
Type 2 diabetes mellitus 13.36 9.86 411 439266 56711 79248000
Escherichia bacteraemia 13.32 9.86 10 439667 6552 79298159
Alpha 1 microglobulin increased 13.31 9.86 7 439670 67 79304644
Respiratory tract oedema 13.28 9.86 20 439657 854 79303857
Breast cancer female 13.23 9.86 27 439650 11434 79293277
Microbiology test abnormal 13.19 9.86 4 439673 6 79304705
Mast cell activation syndrome 13.18 9.86 18 439659 702 79304009
Lung opacity 13.17 9.86 6 439671 5168 79299543
Stent placement 13.15 9.86 10 439667 6510 79298201
Blood prolactin increased 13.12 9.86 3 439674 4008 79300703
Cephalo-pelvic disproportion 13.10 9.86 9 439668 145 79304566
Skin necrosis 13.09 9.86 155 439522 17932 79286779
Substance dependence 13.07 9.86 15 439662 489 79304222
Neurosis 13.05 9.86 14 439663 423 79304288
Weight increased 13.04 9.86 1733 437944 275653 79029058
Osteonecrosis of jaw 13.04 9.86 164 439513 43062 79261649
Skin toxicity 13 9.86 16 439661 8298 79296413
Duodenitis haemorrhagic 12.99 9.86 9 439668 147 79304564
Ductus arteriosus premature closure 12.99 9.86 6 439671 42 79304669
Haemophilia 12.98 9.86 8 439669 106 79304605
Adverse event 12.97 9.86 429 439248 59785 79244926
Superior sagittal sinus thrombosis 12.96 9.86 22 439655 1041 79303670
N-terminal prohormone brain natriuretic peptide increased 12.93 9.86 5 439672 4750 79299961
Haematocrit decreased 12.93 9.86 249 439428 61063 79243648
Psychiatric decompensation 12.89 9.86 3 439674 3960 79300751
Drug tolerance 12.88 9.86 87 439590 8588 79296123
Product storage error 12.87 9.86 46 439631 16180 79288531
Complication of device insertion 12.83 9.86 69 439608 6281 79298430
Phonophobia 12.78 9.86 15 439662 501 79304210
Streptococcal infection 12.78 9.86 88 439589 8742 79295969
Drug intolerance 12.78 9.86 1653 438024 262466 79042245
Influenza 12.75 9.86 584 439093 129022 79175689
Exposure via partner 12.72 9.86 5 439672 22 79304689
Pituitary tumour benign 12.63 9.86 37 439640 2539 79302172
Oculoauriculovertebral dysplasia 12.62 9.86 3 439674 0 79304711
Helicobacter test 12.62 9.86 3 439674 0 79304711
Foetal non-stress test 12.62 9.86 3 439674 0 79304711
Corrosive gastritis 12.62 9.86 3 439674 0 79304711
Vestibular ataxia 12.62 9.86 3 439674 0 79304711
Anastomotic ulcer perforation 12.62 9.86 3 439674 0 79304711
Catheterisation cardiac 12.60 9.86 8 439669 5720 79298991
Mycoplasma test positive 12.55 9.86 10 439667 204 79304507
Product administration error 12.54 9.86 246 439431 31600 79273111
Strawberry tongue 12.54 9.86 5 439672 23 79304688
Anterior interosseous syndrome 12.54 9.86 5 439672 23 79304688
Necrotising fasciitis streptococcal 12.49 9.86 9 439668 157 79304554
Osteomyelitis blastomyces 12.47 9.86 4 439673 8 79304703
Left ventricular failure 12.46 9.86 21 439656 9560 79295151
Haemophagocytic lymphohistiocytosis 12.44 9.86 70 439607 21767 79282944
Foreign body reaction 12.44 9.86 9 439668 158 79304553
Varicella 12.41 9.86 40 439637 2892 79301819
Oedema genital 12.40 9.86 16 439661 590 79304121
Viral mutation identified 12.40 9.86 3 439674 3855 79300856
Monoplegia 12.37 9.86 49 439628 3922 79300789
Polymenorrhagia 12.32 9.86 6 439671 48 79304663
Electrocardiogram QRS complex prolonged 12.32 9.86 102 439575 10731 79293980
Partial seizures 12.31 9.86 19 439658 8959 79295752
Tubulointerstitial nephritis and uveitis syndrome 12.30 9.86 12 439665 323 79304388
Enanthema 12.30 9.86 19 439658 830 79303881
Gastrointestinal fistula 12.27 9.86 18 439659 751 79303960
Gangrene 12.26 9.86 19 439658 8945 79295766
Breast cancer 12.22 9.86 123 439554 33658 79271053
Abscess rupture 12.21 9.86 12 439665 326 79304385
Fungaemia 12.20 9.86 5 439672 4586 79300125
Aortic valve stenosis 12.19 9.86 7 439670 5287 79299424
Ear canal stenosis 12.16 9.86 4 439673 9 79304702
Accidental overdose 12.16 9.86 295 439382 39286 79265425
Reaction to excipient 12.15 9.86 27 439650 1562 79303149
Dermatitis atopic 12.15 9.86 96 439581 9960 79294751
Necrotising soft tissue infection 12.14 9.86 11 439666 269 79304442
Pharyngitis 12.14 9.86 182 439495 22193 79282518
Base excess 12.10 9.86 7 439670 82 79304629
Decubitus ulcer 12.09 9.86 45 439632 15642 79289069
Status asthmaticus 12.08 9.86 21 439656 1013 79303698
Mediastinitis 12.05 9.86 19 439658 845 79303866
Persecutory delusion 12.03 9.86 6 439671 4903 79299808
Thyroid cancer 12.02 9.86 8 439669 5580 79299131
Dermatitis acneiform 12.01 9.86 23 439654 9970 79294741
Hallucination, auditory 11.97 9.86 66 439611 20627 79284084
Mucosal necrosis 11.96 9.86 8 439669 123 79304588
Vulvovaginal dryness 11.93 9.86 33 439644 2191 79302520
Aortic bruit 11.91 9.86 11 439666 276 79304435
Anti-transglutaminase antibody 11.87 9.86 4 439673 10 79304701
Pyoderma streptococcal 11.87 9.86 4 439673 10 79304701
Kawasaki's disease 11.87 9.86 4 439673 10 79304701
Pregnancy 11.82 9.86 211 439466 26640 79278071
Osteolysis 11.79 9.86 5 439672 4493 79300218
Suicidal ideation 11.72 9.86 524 439153 75816 79228895
Otitis media acute 11.70 9.86 24 439653 1313 79303398
Benzodiazepine drug level increased 11.69 9.86 10 439667 226 79304485
Thyroid stimulating immunoglobulin increased 11.67 9.86 7 439670 88 79304623
Blood lactate dehydrogenase increased 11.67 9.86 149 439528 39021 79265690
Drug screen positive 11.65 9.86 65 439612 5998 79298713
Inappropriate antidiuretic hormone secretion 11.64 9.86 91 439586 26222 79278489
Speech sound disorder 11.63 9.86 6 439671 55 79304656
Pelvic adhesions 11.62 9.86 11 439666 285 79304426
Uterine pain 11.53 9.86 9 439668 178 79304533
Prescribed overdose 11.53 9.86 282 439395 37601 79267110
Cardiac arrest 11.53 9.86 805 438872 171291 79133420
Protein urine present 11.53 9.86 24 439653 10088 79294623
Nephritis allergic 11.52 9.86 17 439660 713 79303998
Hepatic cytolysis 11.50 9.86 95 439582 27056 79277655
Mycobacterial infection 11.50 9.86 3 439674 3665 79301046
Genital pain 11.49 9.86 18 439659 796 79303915
Anti-thyroid antibody positive 11.48 9.86 14 439663 487 79304224
Postoperative wound infection 11.48 9.86 35 439642 12926 79291785
Catheter management 11.48 9.86 3 439674 3660 79301051
Eosinophilic granulomatosis with polyangiitis 11.46 9.86 3 439674 3657 79301054
Gastrointestinal erosion 11.45 9.86 21 439656 1057 79303654
Blood creatinine increased 11.45 9.86 719 438958 154338 79150373
Acute haemorrhagic oedema of infancy 11.44 9.86 6 439671 57 79304654
Thrombosis in device 11.43 9.86 8 439669 5434 79299277
Hypertension 11.42 9.86 1625 438052 329367 78975344
Fistula 11.42 9.86 35 439642 12905 79291806
Treatment noncompliance 11.41 9.86 211 439466 52057 79252654
Muscle tightness 11.34 9.86 115 439562 12799 79291912
Henoch-Schonlein purpura nephritis 11.33 9.86 5 439672 31 79304680
Fibromyalgia 11.32 9.86 448 439229 63892 79240819
Pulmonary fibrosis 11.29 9.86 173 439504 43939 79260772
Heart rate increased 11.28 9.86 547 439130 120177 79184534
Hypophosphataemia 11.25 9.86 64 439613 19849 79284862
Herbal interaction 11.24 9.86 14 439663 498 79304213
Loss of personal independence in daily activities 11.18 9.86 457 439220 102123 79202588
Cerebral atrophy 11.16 9.86 17 439660 8058 79296653
Therapy cessation 11.14 9.86 143 439534 37419 79267292
Femoral neck fracture 11.13 9.86 24 439653 9960 79294751
Transient ischaemic attack 11.11 9.86 214 439463 52481 79252230
Osteosclerosis 11.10 9.86 4 439673 3967 79300744
Sebaceous gland disorder 11.10 9.86 6 439671 61 79304650
Blood bilirubin increased 11.09 9.86 279 439398 65953 79238758
Basal ganglion degeneration 11.06 9.86 13 439664 435 79304276
Pneumoperitoneum 11.04 9.86 40 439637 3068 79301643
Cardiac operation 11.02 9.86 7 439670 5005 79299706
Interleukin level increased 11.02 9.86 15 439662 583 79304128
Gait deviation 11.01 9.86 6 439671 62 79304649
Angular cheilitis 10.96 9.86 17 439660 745 79303966
Symblepharon 10.96 9.86 9 439668 192 79304519
Antineutrophil cytoplasmic antibody 10.95 9.86 5 439672 34 79304677
Product dispensing error 10.92 9.86 37 439640 13226 79291485
Normochromic anaemia 10.81 9.86 13 439664 446 79304265
Localised infection 10.80 9.86 144 439533 37431 79267280
Bladder neck obstruction 10.79 9.86 7 439670 102 79304609
Gynaecomastia 10.78 9.86 16 439661 7665 79297046
Tissue infiltration 10.77 9.86 16 439661 675 79304036
Metastases to lymph nodes 10.77 9.86 26 439651 10371 79294340
Strongyloidiasis 10.77 9.86 4 439673 3894 79300817
Mycobacterium avium complex infection 10.71 9.86 6 439671 4594 79300117
Ventriculo-peritoneal shunt 10.71 9.86 5 439672 36 79304675
Catheter site infection 10.71 9.86 13 439664 6782 79297929
JC virus infection 10.69 9.86 4 439673 3877 79300834
Hyperthyroidism 10.69 9.86 75 439602 22134 79282577
Pulmonary thrombosis 10.69 9.86 33 439644 12138 79292573
Oral candidiasis 10.67 9.86 108 439569 29520 79275191
Cholecystitis 10.66 9.86 177 439500 22035 79282676
Carotid artery occlusion 10.66 9.86 16 439661 7631 79297080
Vulval disorder 10.64 9.86 15 439662 603 79304108
Posture abnormal 10.62 9.86 4 439673 3862 79300849
Catheter site erythema 10.62 9.86 8 439669 5232 79299479
Orthopnoea 10.58 9.86 25 439652 10048 79294663
Vertebral artery hypoplasia 10.56 9.86 3 439674 3 79304708
Cystoscopy abnormal 10.56 9.86 3 439674 3 79304708
Renal failure 10.53 9.86 959 438718 200009 79104702
Mycoplasma infection 10.52 9.86 17 439660 772 79303939
Terminal state 10.52 9.86 7 439670 4882 79299829
Personality disorder 10.51 9.86 11 439666 6135 79298576
Oesophageal discomfort 10.50 9.86 11 439666 323 79304388
Drug level below therapeutic 10.47 9.86 24 439653 9746 79294965
Disseminated tuberculosis 10.42 9.86 5 439672 4178 79300533
Thrombosis 10.41 9.86 369 439308 83731 79220980
Bladder prolapse 10.41 9.86 24 439653 1423 79303288
Loss of control of legs 10.39 9.86 29 439648 1936 79302775
Circumoral swelling 10.37 9.86 5 439672 39 79304672
Tonsillitis 10.37 9.86 68 439609 6646 79298065
Menstruation irregular 10.36 9.86 55 439622 4981 79299730
Immunosuppression 10.35 9.86 36 439641 12767 79291944
Embolic stroke 10.32 9.86 17 439660 7809 79296902
Idiosyncratic drug reaction 10.31 9.86 23 439654 1334 79303377
Eye disorder 10.31 9.86 184 439493 23228 79281483
Lower gastrointestinal haemorrhage 10.30 9.86 135 439542 15990 79288721
Pharyngeal oedema 10.30 9.86 136 439541 16136 79288575
Increased upper airway secretion 10.28 9.86 48 439629 4129 79300582
Abnormal uterine bleeding 10.28 9.86 20 439657 1053 79303658
Paronychia 10.26 9.86 17 439660 7791 79296920
Fungal infection 10.25 9.86 165 439512 41583 79263128
Pulmonary function test abnormal 10.25 9.86 5 439672 4139 79300572
Staphylococcal scalded skin syndrome 10.22 9.86 12 439665 401 79304310
Hypoalbuminaemia 10.21 9.86 72 439605 21225 79283486
Haemorrhage subcutaneous 10.19 9.86 7 439670 4802 79299909
Heart rate abnormal 10.18 9.86 11 439666 6046 79298665
Secondary amyloidosis 10.18 9.86 9 439668 213 79304498
Aortic stenosis 10.14 9.86 16 439661 7479 79297232
Myeloma cast nephropathy 10.13 9.86 8 439669 161 79304550
Catheter site haemorrhage 10.13 9.86 8 439669 5109 79299602
Bronchial secretion retention 10.08 9.86 5 439672 4099 79300612
Left ventricular hypertrophy 10.07 9.86 30 439647 11161 79293550
Periorbital swelling 10.06 9.86 37 439640 2859 79301852
Xanthelasma 10.05 9.86 8 439669 163 79304548
Uterine enlargement 10.04 9.86 18 439659 890 79303821
Thrombophlebitis septic 10.02 9.86 11 439666 341 79304370
Left ventricular dysfunction 10.01 9.86 64 439613 19297 79285414
Iritis 10.01 9.86 45 439632 3810 79300901
Blood calcium increased 10.01 9.86 27 439650 10373 79294338
Anion gap abnormal 10.01 9.86 15 439662 638 79304073
Helicobacter gastritis 9.99 9.86 33 439644 2416 79302295
Extra dose administered 9.98 9.86 80 439597 8335 79296376
Palmoplantar keratoderma 9.95 9.86 4 439673 3712 79300999
Skin papilloma 9.95 9.86 61 439616 5825 79298886
Transaminases 9.90 9.86 6 439671 77 79304634
Rheumatoid lung 9.88 9.86 48 439629 4197 79300514
Atelectasis 9.87 9.86 122 439555 32135 79272576

FDA Adverse Event Reporting System (Pediatric)

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
Intestinal perforation 53.58 22.06 22 728 67 88975
Oliguria 33.35 22.06 10 740 6 89036
Intraventricular haemorrhage 30.75 22.06 18 732 138 88904
Product use in unapproved indication 28.21 22.06 10 740 17 89025
Pulmonary arterial hypertension 26.55 22.06 10 740 22 89020
Posthaemorrhagic hydrocephalus 23.38 22.06 13 737 89 88953
Product use issue 22.62 22.06 16 734 175 88867
Nasal congestion 22.44 22.06 9 741 25 89017
Incorrect route of product administration 22.30 22.06 7 743 6 89036

Pharmacologic Action:

SourceCodeDescription
ATC C01EB16 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
OTHER CARDIAC PREPARATIONS
Other cardiac preparations
ATC G02CC01 GENITO URINARY SYSTEM AND SEX HORMONES
OTHER GYNECOLOGICALS
OTHER GYNECOLOGICALS
Antiinflammatory products for vaginal administration
ATC M01AE01 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M01AE51 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M02AA13 MUSCULO-SKELETAL SYSTEM
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Antiinflammatory preparations, non-steroids for topical use
ATC N02AJ08 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ19 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC R02AX02 RESPIRATORY SYSTEM
THROAT PREPARATIONS
THROAT PREPARATIONS
Other throat preparations
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 D002491 Central Nervous System Agents
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
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:48578 free radical scavengers
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
CHEBI has role CHEBI:176497 geroprotectors
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Sinus headache indication 4969004
Pain indication 22253000
Rheumatoid arthritis indication 69896004 DOID:7148
Severe pain indication 76948002
Patent ductus arteriosus indication 83330001 DOID:13832
Headache disorder indication 230461009
Dysmenorrhea indication 266599000
Influenza-like symptoms indication 315642008
Fever indication 386661006
Osteoarthritis indication 396275006
Juvenile rheumatoid arthritis indication 410795001
Acute postoperative pain indication 107401000119105
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005
Ocular hypertension contraindication 4210003 DOID:9282
Suicidal thoughts contraindication 6471006
Dependent drug abuse contraindication 6525002
Alcoholism contraindication 7200002
Alcohol withdrawal delirium contraindication 8635005
Peptic ulcer contraindication 13200003 DOID:750
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Constipation contraindication 14760008 DOID:2089
Mood swings contraindication 18963009
Myocardial infarction contraindication 22298006 DOID:5844
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Hypercapnia contraindication 29596007
Dehydration contraindication 34095006
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Gastrointestinal ulcer contraindication 40845000
Hypothyroidism contraindication 40930008 DOID:1459
Hypokalemia contraindication 43339004
Body fluid retention contraindication 43498006
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Gastrointestinal perforation contraindication 51875005
Gastrectomy contraindication 53442002
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Leber's optic atrophy contraindication 58610003 DOID:705
Hepatic failure contraindication 59927004
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Agoraphobia contraindication 70691001 DOID:593
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Urethral stricture contraindication 76618002
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Chronic idiopathic constipation contraindication 82934008
Cor pulmonale contraindication 83291003 DOID:8515
Atrophic gastritis contraindication 84568007 DOID:8929
Pulmonary emphysema contraindication 87433001
Kidney disease contraindication 90708001 DOID:557
Acute abdominal pain contraindication 116290004
Gastrointestinal obstruction contraindication 126765001
Neoplasm of brain contraindication 126952004 DOID:1319
Seizure disorder contraindication 128613002
Liver function tests abnormal contraindication 166603001
Drug-induced psychosis contraindication 191483003 DOID:1742
Obsessive-compulsive disorder contraindication 191736004 DOID:10933
Impaired renal function disorder contraindication 197663003
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Bladder outflow obstruction contraindication 236645006
Morbid obesity contraindication 238136002 DOID:11981
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Exacerbation of asthma contraindication 281239006
Pregnancy, function contraindication 289908002
Lesion of brain contraindication 301766008
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Thromboembolic disorder contraindication 371039008
Panic disorder contraindication 371631005 DOID:594
Coma contraindication 371632003
Primary adrenocortical insufficiency contraindication 373662000
Operation on gastrointestinal tract contraindication 386621005
Hypoxia contraindication 389086002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Myocardial ischemia contraindication 414795007 DOID:3393
Myocardial infarction in recovery phase contraindication 418044006
Central nervous system depression contraindication 418072004
Dysfunction of sphincter of Oddi contraindication 430887001
Hypertensive urgency contraindication 443482000
Smokes tobacco daily contraindication 449868002
Significant Bleeding contraindication
Acute Thromboembolic Stroke contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.37 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
325MG;97.5MG COMBOGESIC AFT PHARMS LTD N209471 March 1, 2023 RX TABLET ORAL 10532036 Sept. 22, 2025 A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION
26.6MG;800MG DUEXIS HORIZON N022519 April 23, 2011 RX TABLET ORAL 8067451 July 18, 2026 RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS
26.6MG;800MG DUEXIS HORIZON N022519 April 23, 2011 RX TABLET ORAL 8501228 July 18, 2026 RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS
800MG/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS 8735452 Sept. 30, 2029 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS 8871810 Sept. 30, 2029 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 8735452 Sept. 30, 2029 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 8871810 Sept. 30, 2029 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9114068 Sept. 30, 2029 METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER WITH INTRAVENOUS IBUPROFEN SUCH THAT MEAN ARTERIAL BLOOD PRESSURE DOES NOT INCREASE THE DOSAGE INTERVAL
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9138404 Sept. 30, 2029 METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER IN A CRITICALLY ILL PATIENT WITH INTRAVENOUS IBUPROFEN IN NEED THEREOF
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9295639 Sept. 30, 2029 METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER IN A CRITICALLY ILL PATIENT WITH INTRAVENOUS IBUPROFEN IN NEED THEREOF
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9649284 Sept. 30, 2029 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS IN A CRITICALLY ILL PATIENT WITH INTRAVENOUS IBUPROFEN IN NEED THEREOF
800MG/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS 9012508 Sept. 14, 2030 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9012508 Sept. 14, 2030 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS 9072661 March 16, 2032 METHODS OF TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION
800MG/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS 9072710 March 16, 2032 METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION
325MG;97.5MG COMBOGESIC AFT PHARMS LTD N209471 March 1, 2023 RX TABLET ORAL 11197830 Feb. 27, 2039 A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION
325MG;97.5MG COMBOGESIC AFT PHARMS LTD N209471 March 1, 2023 RX TABLET ORAL 11534407 Feb. 27, 2039 A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
250MG;125MG ADVIL DUAL ACTION WITH ACETAMINOPHEN GLAXOSMITHKLINE N211733 Feb. 28, 2020 OTC TABLET ORAL Feb. 28, 2023 NEW PRODUCT
400MG/4ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 DISCN SOLUTION INTRAVENOUS Nov. 19, 2024 CLINICAL TRIAL STUDY RESULTS
800MG/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS Nov. 19, 2024 CLINICAL TRIAL STUDY RESULTS
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS Nov. 19, 2024 CLINICAL TRIAL STUDY RESULTS
325MG;97.5MG COMBOGESIC AFT PHARMS LTD N209471 March 1, 2023 RX TABLET ORAL March 1, 2026 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 5.14 WOMBAT-PK CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR IC50 5.12 WOMBAT-PK CHEMBL
Cytochrome P450 2C9 Enzyme Ki 4.30 WOMBAT-PK
Aldo-keto reductase family 1 member C2 Enzyme IC50 4.37 CHEMBL
Aldo-keto reductase family 1 member C3 Enzyme IC50 4.48 CHEMBL
Arachidonate 5-lipoxygenase Enzyme WOMBAT-PK
Serum albumin Secreted Kd 4.14 CHEMBL
Interleukin-8 Cytokine IC50 7.30 CHEMBL
Sodium-coupled monocarboxylate transporter 1 Transporter INHIBITOR IC50 4.20 IUPHAR
Acid-sensing ion channel 1 Ion channel BLOCKER IC50 3.53 SCIENTIFIC LITERATURE
Fatty acid-binding protein, liver Unclassified Ki 4.32 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 6.07 CHEMBL
Prostaglandin G/H synthase 1 Enzyme Ki 5.05 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 5.96 CHEMBL
Prostaglandin-H2 D-isomerase Enzyme IC50 4.89 CHEMBL
Prostaglandin G/H synthase 2 Enzyme Ki 5.05 CHEMBL
Serum albumin Secreted IC50 5.52 CHEMBL
Solute carrier family 22 member 6 Transporter Ki 5.33 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 5.54 CHEMBL
Solute carrier family 22 member 20 Transporter Ki 5.96 CHEMBL
Cyclooxygenase Enzyme IC50 5.70 CHEMBL
Dehydrogenase/reductase SDR family member 9 Enzyme IC50 4 CHEMBL

External reference:

IDSource
4032936 VUID
N0000189536 NUI
D00126 KEGG_DRUG
57469-77-9 SECONDARY_CAS_RN
4017840 VANDF
4032936 VANDF
C0020740 UMLSCUI
CHEBI:132922 CHEBI
IBP PDB_CHEM_ID
CHEMBL427526 ChEMBL_ID
CHEMBL521 ChEMBL_ID
DB01050 DRUGBANK_ID
CHEMBL1201141 ChEMBL_ID
CHEMBL175 ChEMBL_ID
D007052 MESH_DESCRIPTOR_UI
3672 PUBCHEM_CID
C016106 MESH_SUPPLEMENTAL_RECORD_UI
2713 IUPHAR_LIGAND_ID
2118 INN_ID
527688-20-6 SECONDARY_CAS_RN
WK2XYI10QM UNII
1429044 RXNORM
2133 MMSL
240518 MMSL
32273 MMSL
4862 MMSL
7027 MMSL
82565 MMSL
d00015 MMSL
002377 NDDF
006088 NDDF
006232 NDDF
38268001 SNOMEDCT_US
387207008 SNOMEDCT_US
425516000 SNOMEDCT_US
725863000 SNOMEDCT_US
CHEMBL3989408 ChEMBL_ID
CHEMBL1241153 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ibuprofen and famotidine HUMAN PRESCRIPTION DRUG LABEL 2 0093-8107 TABLET, FILM COATED 800 mg ORAL ANDA 28 sections
good sense ibuprofen pm HUMAN OTC DRUG LABEL 2 0113-0050 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
Good Sense ibuprofeninfants HUMAN OTC DRUG LABEL 1 0113-0057 SUSPENSION 50 mg ORAL ANDA 15 sections
Good Sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0074 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
good sense ibuprofenchildrens HUMAN OTC DRUG LABEL 1 0113-0166 SUSPENSION 100 mg ORAL ANDA 15 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0298 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 16 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0298 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 16 sections
Good Sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0517 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
Good Sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0517 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
Good Sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0517 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0604 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0604 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0647 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0647 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
Good Sense IbuprofenChildrens HUMAN OTC DRUG LABEL 1 0113-0660 SUSPENSION 100 mg ORAL ANDA 15 sections
Good Sense Ibuprofen HUMAN OTC DRUG LABEL 1 0113-0685 SUSPENSION 100 mg ORAL ANDA 15 sections
good sense ibuprofenchildrens HUMAN OTC DRUG LABEL 1 0113-0897 SUSPENSION 100 mg ORAL ANDA 15 sections
Good Sense Ibuprofen HUMAN OTC DRUG LABEL 1 0113-1212 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
Good Sense Ibuprofen HUMAN OTC DRUG LABEL 1 0113-1212 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
basic care childrens ibuprofen HUMAN OTC DRUG LABEL 1 0113-1461 TABLET, CHEWABLE 100 mg ORAL ANDA 15 sections
Good Sense Childrens Ibuprofen HUMAN OTC DRUG LABEL 1 0113-2461 TABLET, CHEWABLE 100 mg ORAL ANDA 15 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-4501 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 16 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-4501 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 16 sections
good sense dual action HUMAN OTC DRUG LABEL 2 0113-5300 TABLET, FILM COATED 125 mg ORAL ANDA 16 sections
basic care ibuprofen HUMAN OTC DRUG LABEL 1 0113-7131 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 16 sections
basic care ibuprofen HUMAN OTC DRUG LABEL 1 0113-7517 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
basic care ibuprofen HUMAN OTC DRUG LABEL 1 0113-7517 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
Basic Care Ibuprofen HUMAN OTC DRUG LABEL 1 0113-7604 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
basic care childrens ibuprofen HUMAN OTC DRUG LABEL 1 0113-7660 SUSPENSION 100 mg ORAL ANDA 15 sections
Basic Care childrens ibuprofen HUMAN OTC DRUG LABEL 1 0113-7897 SUSPENSION 100 mg ORAL ANDA 15 sections