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

Stem definitionDrug idCAS RN
antibiotics, 6-aminopenicillanic acid derivatives 192 26787-78-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • amoxicillin trihydrate
  • amoxicillin
  • amocilline
  • amoxcillin
  • amoxycillin
  • amoxicillin sodium
  • amoxicillin anhydrous
  • amoxicillin hydrate
A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.
  • Molecular weight: 365.40
  • Formula: C16H19N3O5S
  • CLOGP: -1.87
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 4
  • TPSA: 132.96
  • ALOGS: -2.58
  • ROTB: 4

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1.50 g O
3 g P
1.50 g O
3 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 3.50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 86 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 68.42 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 93 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.25 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.85 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.10 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 9, 1974 FDA APOTHECON

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 822.34 9.89 1689 105015 308998 63073320
Rash maculo-papular 673.25 9.89 501 106203 31395 63350923
Drug reaction with eosinophilia and systemic symptoms 495.42 9.89 429 106275 33407 63348911
Angioedema 475.72 9.89 490 106214 47475 63334843
Urticaria 447.48 9.89 910 105794 164892 63217426
Anaphylactic shock 425.87 9.89 338 106366 23295 63359023
Pruritus 421.45 9.89 1449 105255 360004 63022314
Erythema 397.58 9.89 898 105806 174853 63207465
Acute generalised exanthematous pustulosis 344.18 9.89 221 106483 10878 63371440
Cross sensitivity reaction 317.43 9.89 124 106580 2038 63380280
Macular degeneration 293.64 9.89 277 106427 24099 63358219
Pemphigus 283.60 9.89 5 106699 183721 63198597
Anaphylactic reaction 264.90 9.89 431 106273 65669 63316649
Synovitis 253.94 9.89 15 106689 186903 63195415
Lip swelling 249.49 9.89 284 106420 30779 63351539
Type IV hypersensitivity reaction 247.22 9.89 113 106591 2785 63379533
Lip oedema 246.47 9.89 124 106580 3800 63378518
Toxic skin eruption 244.42 9.89 190 106514 12695 63369623
Face oedema 242.14 9.89 229 106475 19983 63362335
Systemic lupus erythematosus 229.09 9.89 38 106666 208880 63173438
Abortion spontaneous 228.69 9.89 336 106368 46859 63335459
Swelling face 212.31 9.89 382 106322 63093 63319225
Rash 208.66 9.89 1632 105072 559239 62823079
Type I hypersensitivity 205.68 9.89 100 106604 2842 63379476
Drug ineffective 196.78 9.89 998 105706 1043767 62338551
Glossodynia 190.69 9.89 35 106669 178841 63203477
Alopecia 188.38 9.89 174 106530 337362 63044956
Swollen tongue 179.14 9.89 255 106449 34545 63347773
Hepatocellular injury 173.51 9.89 222 106482 27159 63355159
Arthropathy 173.50 9.89 89 106615 234703 63147615
Acute kidney injury 168.87 9.89 881 105823 262534 63119784
Pericarditis 168.71 9.89 14 106690 131565 63250753
Hand deformity 162.00 9.89 35 106669 159422 63222896
Paraesthesia oral 157.91 9.89 178 106526 19078 63363240
Rash pruritic 145.57 9.89 315 106389 59484 63322834
Crystalluria 138.24 9.89 44 106660 379 63381939
Chronic sinusitis 135.98 9.89 136 106568 12707 63369611
Abdominal discomfort 135.57 9.89 206 106498 320679 63061639
Tongue oedema 134.03 9.89 88 106616 4498 63377820
Toxic epidermal necrolysis 130.91 9.89 186 106518 25148 63357170
Stevens-Johnson syndrome 128.66 9.89 183 106521 24767 63357551
Eosinophilia 127.95 9.89 174 106530 22582 63359736
Therapeutic product effect decreased 127.39 9.89 84 106620 193103 63189215
White blood cell count abnormal 127.06 9.89 96 106608 6146 63376172
Wound 126.47 9.89 58 106646 163205 63219113
Duodenal ulcer perforation 124.77 9.89 5 106699 87204 63295114
Completed suicide 120.44 9.89 47 106657 145626 63236692
Cholecystitis chronic 115.78 9.89 113 106591 10248 63372070
Product use issue 115.59 9.89 120 106584 220400 63161918
Contraindicated product administered 113.45 9.89 119 106585 217529 63164789
Rash erythematous 112.82 9.89 232 106472 42278 63340040
Rash macular 111.21 9.89 165 106539 23199 63359119
Jaundice 110.75 9.89 186 106518 29065 63353253
Discomfort 110.03 9.89 73 106631 167301 63215017
Death 109.76 9.89 297 106407 374084 63008234
Erythema multiforme 106.40 9.89 107 106597 10062 63372256
Fatigue 104.93 9.89 972 105732 887056 62495262
Arthralgia 104.48 9.89 548 106156 569162 62813156
Treatment failure 102.42 9.89 110 106594 198933 63183385
Wound closure 101.42 9.89 26 106678 90 63382228
Infusion related reaction 98.53 9.89 163 106541 245358 63136960
Hepatic enzyme increased 97.39 9.89 118 106586 202210 63180108
Cholestasis 94.38 9.89 174 106530 29260 63353058
Enterocolitis haemorrhagic 91.11 9.89 46 106658 1420 63380898
Fall 88.79 9.89 349 106355 391985 62990333
Tubulointerstitial nephritis 86.85 9.89 135 106569 19768 63362550
Hepatitis cholestatic 86.34 9.89 80 106624 6798 63375520
Muscle injury 83.60 9.89 7 106697 65338 63316980
Osteotomy 82.94 9.89 26 106678 212 63382106
Mobility decreased 79.40 9.89 53 106651 121106 63261212
Helicobacter infection 78.23 9.89 29 106675 92756 63289562
Joint swelling 76.99 9.89 287 106417 327379 63054939
Folliculitis 76.54 9.89 13 106691 70304 63312014
Hallucinations, mixed 76.29 9.89 64 106640 4765 63377553
Meningitis aseptic 72.26 9.89 62 106642 4761 63377557
Rash morbilliform 71.83 9.89 53 106651 3272 63379046
Swelling 71.55 9.89 231 106473 275147 63107171
Drug intolerance 68.87 9.89 276 106428 308385 63073933
Flank pain 68.41 9.89 109 106595 16301 63366017
Skin test positive 67.05 9.89 30 106674 702 63381616
Dermatitis allergic 66.45 9.89 103 106601 15045 63367273
Off label use 66.40 9.89 770 105934 673692 62708626
Laryngeal oedema 65.08 9.89 63 106641 5655 63376663
C-reactive protein abnormal 64.74 9.89 3 106701 46093 63336225
Loss of personal independence in daily activities 64.49 9.89 42 106662 97248 63285070
Intentional product use issue 63.21 9.89 73 106631 127819 63254499
Impaired healing 63.06 9.89 48 106656 102494 63279824
Psoriatic arthropathy 62.75 9.89 38 106666 91482 63290836
Emotional distress 62.23 9.89 156 106548 32393 63349925
Dermatitis exfoliative generalised 61.27 9.89 51 106653 3756 63378562
Irritable bowel syndrome 61.16 9.89 31 106673 82381 63299937
Female genital tract fistula 58.79 9.89 68 106636 7491 63374827
Eyelid oedema 58.71 9.89 80 106624 10399 63371919
Throat tightness 58.15 9.89 129 106575 24758 63357560
Periorbital oedema 57.99 9.89 59 106645 5625 63376693
Stomatitis 57.58 9.89 90 106614 138635 63243683
Drug eruption 57.47 9.89 140 106564 28554 63353764
Thermal burn 56.72 9.89 60 106644 5986 63376332
Skin candida 56.42 9.89 35 106669 1620 63380698
Allergy to chemicals 53.69 9.89 43 106661 2999 63379319
Clostridium difficile infection 53.67 9.89 140 106564 29782 63352536
Condition aggravated 53.12 9.89 427 106277 401790 62980528
Blood cholesterol increased 52.90 9.89 48 106656 93984 63288334
Salpingo-oophorectomy unilateral 52.87 9.89 27 106677 854 63381464
Hepatic cytolysis 51.82 9.89 93 106611 15314 63367004
Bronchospasm 51.48 9.89 99 106605 17181 63365137
Injection site pain 51.25 9.89 87 106617 129713 63252605
Eczema 49.86 9.89 143 106561 32148 63350170
Injection site erythema 49.79 9.89 40 106664 83134 63299184
Malaise 49.13 9.89 976 105728 414978 62967340
Candida infection 48.16 9.89 130 106574 28221 63354097
Ill-defined disorder 48.09 9.89 40 106664 81715 63300603
Abdominal pain 47.76 9.89 725 105979 292731 63089587
Hyperleukocytosis 47.00 9.89 23 106681 663 63381655
Rheumatic fever 46.85 9.89 8 106696 43103 63339215
Sinusitis fungal 46.02 9.89 32 106672 1799 63380519
Tooth demineralisation 45.93 9.89 9 106695 3 63382315
Basilar artery occlusion 45.91 9.89 14 106690 103 63382215
Agranulocytosis 45.49 9.89 118 106586 25016 63357302
Adverse event 45.00 9.89 29 106675 67530 63314788
Diarrhoea 44.06 9.89 1540 105164 713826 62668492
Hip arthroplasty 43.46 9.89 13 106691 47633 63334685
Pseudomembranous colitis 42.59 9.89 38 106666 3074 63379244
Purpura 42.56 9.89 72 106632 11313 63371005
Vascular purpura 42.31 9.89 28 106676 1450 63380868
Weight increased 42.15 9.89 261 106443 260531 63121787
Clostridium difficile colitis 41.88 9.89 101 106603 20468 63361850
Palatal oedema 41.24 9.89 20 106684 565 63381753
Gastrointestinal disorder 38.44 9.89 104 106600 131135 63251183
Premature baby 38.20 9.89 98 106606 20637 63361681
General physical health deterioration 37.73 9.89 192 106512 201210 63181108
Sputum increased 37.63 9.89 32 106672 2427 63379891
International normalised ratio increased 37.38 9.89 166 106538 46259 63336059
Dermatitis exfoliative 37.34 9.89 46 106658 5413 63376905
Acute hepatic failure 37.32 9.89 90 106614 18237 63364081
Allergy test positive 37.21 9.89 19 106685 601 63381717
Vaginal flatulence 36.95 9.89 36 106668 3257 63379061
Documented hypersensitivity to administered product 36.52 9.89 18 106686 527 63381791
Drug-induced liver injury 36.39 9.89 149 106555 40073 63342245
Rheumatoid arthritis 36.03 9.89 264 106440 253555 63128763
Chronic kidney disease 35.56 9.89 161 106543 45237 63337081
Dental operation 35.06 9.89 24 106680 1315 63381003
Chromaturia 35.02 9.89 83 106621 16634 63365684
Allergy test negative 34.60 9.89 13 106691 191 63382127
Dysphonia 34.46 9.89 165 106539 47449 63334869
Maternal exposure during pregnancy 34.36 9.89 540 106164 219522 63162796
Foetal exposure during pregnancy 34.31 9.89 125 106579 31837 63350481
Peripheral swelling 33.39 9.89 286 106418 265656 63116662
Fixed eruption 33.20 9.89 22 106682 1142 63381176
Hepatic ischaemia 33.17 9.89 18 106686 646 63381672
Vomiting 32.96 9.89 1199 105505 558418 62823900
Oral discomfort 32.83 9.89 57 106647 9144 63373174
Device expulsion 32.83 9.89 9 106695 34913 63347405
Tongue discolouration 32.75 9.89 33 106671 3110 63379208
Therapeutic response decreased 32.74 9.89 33 106671 61492 63320826
Nasopharyngitis 32.56 9.89 272 106432 253985 63128333
Knee arthroplasty 32.52 9.89 26 106678 54180 63328138
Somatic delusion 32.25 9.89 17 106687 575 63381743
Dermatitis bullous 32.06 9.89 54 106650 8454 63373864
Red blood cell sedimentation rate increased 31.95 9.89 17 106687 43965 63338353
Procedural pain 31.83 9.89 94 106610 21475 63360843
Febrile neutropenia 31.67 9.89 98 106606 118351 63263967
Excessive eye blinking 31.30 9.89 22 106682 1258 63381060
Type 2 diabetes mellitus 30.96 9.89 37 106667 63831 63318487
Injury 30.30 9.89 219 106485 73028 63309290
Deafness 30.16 9.89 82 106622 17875 63364443
Deep vein thrombosis 29.89 9.89 242 106462 83558 63298760
Peritonsillar abscess 29.88 9.89 16 106688 559 63381759
Fibromyalgia 29.85 9.89 56 106648 80364 63301954
Amyloid arthropathy 29.75 9.89 16 106688 564 63381754
Injection site swelling 29.58 9.89 22 106682 47550 63334768
Breast cancer 29.29 9.89 23 106681 48360 63333958
Tooth infection 29.27 9.89 81 106623 17839 63364479
Conjunctivitis 29.15 9.89 89 106615 20707 63361611
Vaginal discharge 29.01 9.89 54 106650 9144 63373174
Blister 28.95 9.89 116 106588 129698 63252620
Crepitations 28.94 9.89 50 106654 7990 63374328
Linear IgA disease 28.83 9.89 22 106682 1429 63380889
Sebaceous gland infection 28.66 9.89 11 106693 172 63382146
Gallbladder disorder 28.66 9.89 83 106621 18759 63363559
Drug interaction 28.45 9.89 542 106162 228589 63153729
Prescribed overdose 28.24 9.89 11 106693 34142 63348176
Malignant neoplasm progression 28.06 9.89 60 106644 82061 63300257
Moraxella test positive 27.82 9.89 7 106697 22 63382296
Neutropenic sepsis 27.54 9.89 75 106629 16363 63365955
Respiratory symptom 27.54 9.89 31 106673 3316 63379002
Embolism venous 27.30 9.89 30 106674 3124 63379194
Hypertension 27.29 9.89 319 106385 278984 63103334
Premature delivery 27.25 9.89 112 106592 30169 63352149
Osteonecrosis of jaw 27.09 9.89 124 106580 34999 63347319
Obstructive airways disorder 26.64 9.89 86 106618 20613 63361705
Radiculopathy 26.47 9.89 50 106654 8561 63373757
Contusion 26.44 9.89 146 106558 149898 63232420
Wheezing 25.87 9.89 260 106444 95335 63286983
Tenosynovitis stenosans 25.72 9.89 30 106674 3334 63378984
Tubulointerstitial nephritis and uveitis syndrome 25.55 9.89 11 106693 234 63382084
Pharyngeal oedema 25.43 9.89 65 106639 13656 63368662
Muscle relaxant therapy 25.34 9.89 10 106694 169 63382149
Proctitis 25.28 9.89 38 106666 5403 63376915
Normal tension glaucoma 25.25 9.89 7 106697 35 63382283
Eye swelling 25.22 9.89 93 106611 23825 63358493
Mixed liver injury 24.80 9.89 35 106669 4700 63377618
Pain in extremity 24.71 9.89 400 106304 331086 63051232
Hepatitis 24.66 9.89 132 106572 39656 63342662
Anhedonia 24.65 9.89 56 106648 10918 63371400
Staphylococcal scalded skin syndrome 24.62 9.89 9 106695 122 63382196
Influenza B virus test positive 24.41 9.89 11 106693 262 63382056
Mouth ulceration 24.37 9.89 115 106589 32869 63349449
Synovial fluid analysis 24.36 9.89 25 106679 2408 63379910
Incision site haemorrhage 24.17 9.89 14 106690 571 63381747
Incorrect route of product administration 24.13 9.89 8 106696 27444 63354874
Prescribed underdose 23.83 9.89 10 106694 29679 63352639
Fluid retention 23.55 9.89 40 106664 59646 63322672
Hepatorenal syndrome 23.34 9.89 22 106682 1910 63380408
Injection site pruritus 23.10 9.89 25 106679 45091 63337227
Localised oedema 22.79 9.89 36 106668 5342 63376976
Biliary sepsis 22.76 9.89 16 106688 915 63381403
Lymphadenopathy 22.76 9.89 126 106578 38332 63343986
Crystal nephropathy 22.69 9.89 16 106688 920 63381398
Blood glucose increased 22.59 9.89 69 106635 83687 63298631
Pain 22.08 9.89 1019 105685 739609 62642709
Biliary dyskinesia 21.98 9.89 25 106679 2704 63379614
Drug abuse 21.58 9.89 57 106647 72461 63309857
Fibrous histiocytoma 21.51 9.89 13 106691 574 63381744
Skin exfoliation 21.50 9.89 135 106569 42967 63339351
Pyrexia 21.42 9.89 981 105723 469497 62912821
Tongue coated 21.26 9.89 18 106686 1357 63380961
Psychotic symptom 21.24 9.89 19 106685 1542 63380776
Foetal non-stress test abnormal 21.02 9.89 6 106698 34 63382284
Lip and/or oral cavity cancer 20.96 9.89 15 106689 883 63381435
Toxicity to various agents 20.94 9.89 291 106413 246959 63135359
Dyspnoea 20.79 9.89 1332 105372 659981 62722337
Pharyngeal swelling 20.70 9.89 38 106666 6366 63375952
Scleritis 20.68 9.89 31 106673 4397 63377921
Multiple sclerosis relapse 20.53 9.89 31 106673 48447 63333871
Serum sickness-like reaction 20.53 9.89 12 106692 498 63381820
Allergic hepatitis 20.45 9.89 6 106698 38 63382280
Pleuritic pain 20.33 9.89 43 106661 7986 63374332
Device malfunction 20.11 9.89 3 106701 17854 63364464
Coagulopathy 20.10 9.89 78 106626 20466 63361852
Myocardial infarction 19.98 9.89 93 106611 99800 63282518
Tinnitus 19.94 9.89 115 106589 35513 63346805
Enterocolitis 19.80 9.89 42 106662 7816 63374502
Eosinophilic pneumonia acute 19.77 9.89 11 106693 415 63381903
Diabetes mellitus 19.72 9.89 40 106664 55770 63326548
Lower limb fracture 19.70 9.89 8 106696 24213 63358105
Rash pustular 19.61 9.89 40 106664 7242 63375076
Lip erosion 19.61 9.89 15 106689 978 63381340
Oral candidiasis 19.48 9.89 83 106621 22715 63359603
Foetal heart rate decreased 19.46 9.89 8 106696 151 63382167
Underdose 19.38 9.89 11 106693 27445 63354873
Blood pressure increased 19.13 9.89 177 106527 161885 63220433
Rash papular 19.09 9.89 64 106640 15638 63366680
Mouth swelling 19.09 9.89 31 106673 4709 63377609
Labile blood pressure 19.04 9.89 19 106685 1770 63380548
Pregnancy on oral contraceptive 19.03 9.89 15 106689 1022 63381296
Pulmonary artery stenosis congenital 18.90 9.89 9 106695 244 63382074
Eosinophils urine present 18.74 9.89 5 106699 21 63382297
Hyperaemia 18.72 9.89 21 106683 2238 63380080
Campylobacter infection 18.54 9.89 15 106689 1061 63381257
Nasal polyps 18.48 9.89 35 106669 6004 63376314
Hypoaesthesia oral 18.48 9.89 56 106648 12977 63369341
Selective eating disorder 18.44 9.89 20 106684 2052 63380266
Sedation 18.26 9.89 23 106681 38786 63343532
Haematuria 18.25 9.89 97 106607 29060 63353258
Injection site reaction 18.18 9.89 45 106659 58479 63323839
Tricuspid valve incompetence 18.14 9.89 60 106644 14561 63367757
Symmetrical drug-related intertriginous and flexural exanthema 18.05 9.89 11 106693 493 63381825
Delirium 18.05 9.89 36 106668 50505 63331813
Accidental exposure to product 17.92 9.89 12 106692 27393 63354925
Gamma-glutamyltransferase increased 17.86 9.89 108 106596 33923 63348395
Pneumonia aspiration 17.84 9.89 19 106685 34521 63347797
Tooth discolouration 17.76 9.89 14 106690 954 63381364
Hepatitis acute 17.73 9.89 44 106660 9076 63373242
Injection site alopecia 17.72 9.89 5 106699 27 63382291
Odynophagia 17.71 9.89 39 106665 7447 63374871
Skin reaction 17.60 9.89 60 106644 14789 63367529
Choluria 17.47 9.89 8 106696 198 63382120
Atelectasis 17.43 9.89 77 106627 21406 63360912
Prothrombin time ratio decreased 17.39 9.89 11 106693 527 63381791
Eosinophilic pneumonia 17.38 9.89 20 106684 2191 63380127
Septic shock 17.19 9.89 56 106648 66573 63315745
Budd-Chiari syndrome 17.15 9.89 6 106698 71 63382247
Fear-related avoidance of activities 17.13 9.89 7 106697 130 63382188
Allergy to arthropod bite 17.08 9.89 9 106695 304 63382014
Gait inability 17.03 9.89 40 106664 52919 63329399
Bone marrow eosinophilic leukocyte count increased 17.00 9.89 5 106699 32 63382286
Nail dystrophy 16.84 9.89 14 106690 1029 63381289
Therapy non-responder 16.80 9.89 68 106636 75833 63306485
Diastolic dysfunction 16.79 9.89 35 106669 6436 63375882
Laryngeal discomfort 16.76 9.89 9 106695 316 63382002
Ocular hyperaemia 16.67 9.89 85 106619 25059 63357259
Respiratory disorder neonatal 16.64 9.89 15 106689 1230 63381088
Allergy to animal 16.63 9.89 15 106689 1231 63381087
Blood pressure fluctuation 16.53 9.89 33 106671 46284 63336034
Norovirus test positive 16.50 9.89 8 106696 226 63382092
Reaction to excipient 16.42 9.89 16 106688 1448 63380870
Diastasis recti abdominis 16.37 9.89 5 106699 37 63382281
Bipolar I disorder 16.33 9.89 18 106686 1881 63380437
Renal colic 16.26 9.89 16 106688 1465 63380853
Atrial septal defect 16.25 9.89 36 106668 6902 63375416
Arthritis 16.22 9.89 121 106583 115800 63266518
Congenital melanocytic naevus 16.17 9.89 3 106701 0 63382318
Injection site warmth 16.12 9.89 3 106701 15192 63367126
Pharyngotonsillitis 15.92 9.89 7 106697 157 63382161
Respiratory failure 15.88 9.89 103 106601 101755 63280563
Urinary tract obstruction 15.74 9.89 19 106685 2189 63380129
Toothache 15.72 9.89 69 106635 19130 63363188
Serotonin syndrome 15.70 9.89 15 106689 28667 63353651
Hepatic failure 15.55 9.89 108 106596 35548 63346770
Jarisch-Herxheimer reaction 15.52 9.89 9 106695 368 63381950
Pharyngeal paraesthesia 15.50 9.89 18 106686 1991 63380327
Genital erosion 15.48 9.89 7 106697 168 63382150
Autoimmune hepatitis 15.44 9.89 40 106664 8470 63373848
Injection site haemorrhage 15.43 9.89 11 106693 24303 63358015
Tryptase increased 15.38 9.89 9 106695 374 63381944
Macule 15.36 9.89 18 106686 2010 63380308
Cheilitis 15.36 9.89 26 106678 4087 63378231
Pharyngitis streptococcal 15.26 9.89 46 106658 10626 63371692
Femoral artery embolism 15.23 9.89 5 106699 48 63382270
PRIDE syndrome 15.15 9.89 4 106700 16 63382302
Pharyngeal abscess 15.06 9.89 8 106696 275 63382043
Polymenorrhagia 15.05 9.89 5 106699 50 63382268
Biliary colic 15.04 9.89 24 106680 3593 63378725
Cognitive disorder 15.04 9.89 46 106658 55769 63326549
Visual snow syndrome 14.96 9.89 5 106699 51 63382267
Parotid gland enlargement 14.87 9.89 12 106692 846 63381472
Tenosynovitis 14.85 9.89 54 106650 13741 63368577
Cell death 14.79 9.89 20 106684 2581 63379737
Cholecystitis 14.73 9.89 58 106646 15319 63366999
Macroglossia 14.70 9.89 11 106693 694 63381624
Osteolysis 14.69 9.89 21 106683 2853 63379465
Myelosuppression 14.69 9.89 11 106693 23692 63358626
Pseudomyopia 14.62 9.89 5 106699 55 63382263
Deformity 14.54 9.89 48 106656 11636 63370682
Skin swelling 14.45 9.89 23 106681 3436 63378882
Vasoplegia syndrome 14.43 9.89 16 106688 1683 63380635
Pharyngeal erythema 14.36 9.89 16 106688 1692 63380626
Pulmonary pain 14.29 9.89 23 106681 3467 63378851
Target skin lesion 14.28 9.89 6 106698 120 63382198
Caffeine allergy 14.27 9.89 4 106700 21 63382297
Atrophy 14.18 9.89 16 106688 1716 63380602
Sedation complication 14.09 9.89 3 106701 13819 63368499
Forced vital capacity abnormal 13.96 9.89 4 106700 23 63382295
Haemolytic anaemia 13.88 9.89 43 106661 10082 63372236
Hepatic necrosis 13.88 9.89 30 106674 5657 63376661
Diverticulum 13.81 9.89 48 106656 11943 63370375
Circulatory collapse 13.74 9.89 73 106631 21865 63360453
Emphysema 13.67 9.89 45 106659 10893 63371425
Cardiac failure congestive 13.65 9.89 95 106609 92338 63289980
Fracture 13.60 9.89 8 106696 19576 63362742
Viral rash 13.55 9.89 8 106696 338 63381980
Oral fungal infection 13.53 9.89 21 106683 3070 63379248
Facial paralysis 13.49 9.89 53 106651 13988 63368330
Ear infection 13.43 9.89 110 106594 38103 63344215
Photophobia 13.40 9.89 62 106642 17573 63364745
Gallbladder cholesterolosis 13.39 9.89 11 106693 795 63381523
Mucosal inflammation 13.35 9.89 129 106575 46799 63335519
Eye pain 13.30 9.89 100 106604 33754 63348564
Ureteric obstruction 13.18 9.89 16 106688 1854 63380464
Mucosal discolouration 13.05 9.89 9 106695 499 63381819
Caesarean section 13.03 9.89 60 106644 16972 63365346
Cholestasis of pregnancy 13.02 9.89 13 106691 1212 63381106
Grip strength decreased 12.98 9.89 11 106693 22276 63360042
Mania 12.96 9.89 48 106656 12319 63369999
Dysphagia 12.91 9.89 215 106489 88370 63293948
Delusion of grandeur 12.88 9.89 7 106697 252 63382066
Foetal hypokinesia 12.86 9.89 9 106695 511 63381807
Monoclonal gammopathy 12.85 9.89 10 106694 669 63381649
Neutrophilia 12.82 9.89 25 106679 4381 63377937
Idiopathic urticaria 12.80 9.89 7 106697 255 63382063
Actinomycosis 12.77 9.89 12 106692 1038 63381280
Full blood count abnormal 12.75 9.89 21 106683 31696 63350622
Adverse drug reaction 12.74 9.89 80 106624 79634 63302684
Cerebellar syndrome 12.73 9.89 22 106682 3517 63378801
Infectious mononucleosis 12.72 9.89 16 106688 1923 63380395
Carcinoid crisis 12.70 9.89 7 106697 259 63382059
Sciatica 12.65 9.89 24 106680 34300 63348018
Injection site rash 12.62 9.89 8 106696 18801 63363517
SJS-TEN overlap 12.61 9.89 8 106696 385 63381933
Tangentiality 12.61 9.89 4 106700 34 63382284
Tongue pruritus 12.59 9.89 9 106695 529 63381789
Sweat discolouration 12.57 9.89 3 106701 7 63382311
Vertebrobasilar insufficiency 12.52 9.89 6 106698 165 63382153
Inappropriate schedule of product administration 12.50 9.89 113 106591 103852 63278466
Oedema 12.47 9.89 232 106472 97390 63284928
Low birth weight baby 12.42 9.89 33 106671 7096 63375222
Lymphocytosis 12.39 9.89 19 106685 2748 63379570
Klebsiella infection 12.32 9.89 37 106667 8529 63373789
Delayed delivery 12.31 9.89 4 106700 37 63382281
Palatal swelling 12.23 9.89 5 106699 93 63382225
Idiopathic angioedema 12.22 9.89 4 106700 38 63382280
Posterior reversible encephalopathy syndrome 12.17 9.89 7 106697 17338 63364980
Neoplasm progression 12.12 9.89 27 106677 36401 63345917
Glomerulonephritis acute 12.08 9.89 5 106699 96 63382222
Product storage error 12.06 9.89 5 106699 14951 63367367
Maternal drugs affecting foetus 12.05 9.89 27 106677 5215 63377103
Disease progression 12.05 9.89 140 106564 122618 63259700
Congenital tricuspid valve incompetence 12.04 9.89 5 106699 97 63382221
Genital prolapse 12.04 9.89 4 106700 40 63382278
Palatal polyp 12.03 9.89 3 106701 9 63382309
Enanthema 12.03 9.89 8 106696 418 63381900
Right ventricular failure 11.97 9.89 7 106697 17181 63365137
Transaminases increased 11.95 9.89 92 106612 31275 63351043
Serum sickness 11.92 9.89 19 106685 2841 63379477
Anaphylactoid reaction 11.92 9.89 22 106682 3701 63378617
Lip pain 11.87 9.89 15 106689 1811 63380507
Breast cancer female 11.83 9.89 4 106700 13555 63368763
Lice infestation 11.79 9.89 3 106701 10 63382308
Quality of life decreased 11.71 9.89 37 106667 8766 63373552
Injection site bruising 11.68 9.89 34 106670 41876 63340442
Dysstasia 11.67 9.89 11 106693 21155 63361163
Behaviour disorder 11.65 9.89 20 106684 3179 63379139
Cholelithiasis 11.65 9.89 119 106585 43806 63338512
Hiatus hernia 11.63 9.89 69 106635 21525 63360793
Life expectancy shortened 11.62 9.89 4 106700 45 63382273
Exposed bone in jaw 11.60 9.89 19 106685 2906 63379412
Electrocardiogram QT prolonged 11.56 9.89 56 106648 59474 63322844
Lymphocyte morphology abnormal 11.53 9.89 8 106696 448 63381870
Blood test abnormal 11.41 9.89 6 106698 15623 63366695
Hepatitis toxic 11.41 9.89 20 106684 3233 63379085
XIth nerve injury 11.38 9.89 4 106700 48 63382270
Synovial cyst 11.36 9.89 41 106663 10392 63371926
Lymphadenitis 11.31 9.89 20 106684 3255 63379063
Exposure keratitis 11.31 9.89 4 106700 49 63382269
Bone erosion 11.26 9.89 8 106696 17709 63364609
Abnormal faeces 11.25 9.89 27 106677 5453 63376865
Fulminant type 1 diabetes mellitus 11.24 9.89 8 106696 467 63381851
Tracheal pain 11.23 9.89 4 106700 50 63382268
Retinal neovascularisation 11.23 9.89 4 106700 50 63382268
Myalgia 11.18 9.89 324 106380 146205 63236113
Skin lesion 11.10 9.89 89 106615 30632 63351686
Rash scarlatiniform 11.10 9.89 5 106699 119 63382199
Otitis media 11.03 9.89 25 106679 4866 63377452
Tracheal injury 11.02 9.89 4 106700 53 63382265
Pneumopericardium 11.02 9.89 4 106700 53 63382265
Therapeutic product effect incomplete 11.00 9.89 146 106558 124910 63257408
Sleep disorder 11 9.89 86 106618 81480 63300838
Oropharyngeal discomfort 10.89 9.89 26 106678 5234 63377084
Injection site urticaria 10.88 9.89 5 106699 14068 63368250
Gingivitis 10.83 9.89 35 106669 8394 63373924
Frequent bowel movements 10.80 9.89 71 106633 22951 63359367
Platelet count decreased 10.80 9.89 134 106570 115988 63266330
Tympanic membrane perforation 10.79 9.89 15 106689 1986 63380332
Meningioma surgery 10.76 9.89 4 106700 57 63382261
Asthenia 10.74 9.89 531 106173 383073 62999245
Hepatomegaly 10.72 9.89 44 106660 11845 63370473
Cushingoid 10.69 9.89 35 106669 8450 63373868
Uterine contractions abnormal 10.67 9.89 6 106698 231 63382087
Depressed level of consciousness 10.60 9.89 61 106643 62017 63320301
Pulmonary fibrosis 10.59 9.89 33 106671 39776 63342542
Swelling of eyelid 10.55 9.89 19 106685 3137 63379181
Lip ulceration 10.51 9.89 15 106689 2035 63380283
Loefgren syndrome 10.45 9.89 5 106699 137 63382181
Human herpesvirus 6 encephalitis 10.44 9.89 6 106698 241 63382077
Respiratory depression 10.41 9.89 5 106699 13710 63368608
Hepatosplenomegaly 10.40 9.89 17 106687 2597 63379721
Product dose omission issue 10.39 9.89 307 106397 234006 63148312
Foetal distress syndrome 10.34 9.89 12 106692 1326 63380992
Intentional self-injury 10.33 9.89 17 106687 25670 63356648
Weight abnormal 10.30 9.89 12 106692 1332 63380986
Spinal subdural haematoma 10.29 9.89 5 106699 142 63382176
Erythromelalgia 10.22 9.89 5 106699 144 63382174
Pneumonia mycoplasmal 10.17 9.89 10 106694 915 63381403
Neonatal respiratory distress 10.15 9.89 7 106697 388 63381930
Femur fracture 10.15 9.89 36 106668 41720 63340598
Bone disorder 10.14 9.89 66 106638 21260 63361058
Transverse sinus thrombosis 10.09 9.89 8 106696 550 63381768
Coma 10.08 9.89 65 106639 64299 63318019
Claudication of jaw muscles 10.01 9.89 4 106700 70 63382248
Erythema nodosum 9.99 9.89 24 106680 4851 63377467
Vitiligo 9.98 9.89 12 106692 1377 63380941
Sebaceous gland disorder 9.97 9.89 3 106701 21 63382297
Abdominal rebound tenderness 9.97 9.89 3 106701 21 63382297
Tonsillitis streptococcal 9.96 9.89 4 106700 71 63382247
Multiple lentigines syndrome 9.94 9.89 5 106699 153 63382165
Herpes simplex test positive 9.90 9.89 6 106698 266 63382052

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug reaction with eosinophilia and systemic symptoms 529.79 10.15 462 65081 32550 34858838
Anaphylactic shock 519.76 10.15 341 65202 15600 34875788
Urticaria 440.23 10.15 563 64980 61814 34829574
Pruritus 415.04 10.15 858 64685 141123 34750265
Rash maculo-papular 316.20 10.15 325 65218 28126 34863262
Rash 250.56 10.15 950 64593 221802 34669586
Lip oedema 234.13 10.15 109 65434 2504 34888884
Anaphylactic reaction 233.05 10.15 295 65248 32006 34859382
Angioedema 222.98 10.15 311 65232 37063 34854325
Acute generalised exanthematous pustulosis 218.45 10.15 144 65399 6632 34884756
Erythema 218.35 10.15 501 65042 88279 34803109
Death 194.49 10.15 279 65264 397770 34493618
Meningitis aseptic 192.34 10.15 102 65441 3122 34888266
Cholestasis 187.89 10.15 242 65301 26706 34864682
Face oedema 178.20 10.15 158 65385 11358 34880030
Hepatocellular injury 178.15 10.15 214 65329 21997 34869391
Drug hypersensitivity 177.96 10.15 436 65107 80093 34811295
Eosinophilia 171.20 10.15 228 65315 25994 34865394
Crystalluria 167.91 10.15 54 65489 427 34890961
Cross sensitivity reaction 149.62 10.15 66 65477 1331 34890057
Acute kidney injury 133.85 10.15 1003 64540 303985 34587403
Type I hypersensitivity 132.97 10.15 60 65483 1279 34890109
Lip swelling 111.41 10.15 144 65399 15936 34875452
Toxic epidermal necrolysis 111.36 10.15 168 65375 21478 34869910
Rash erythematous 107.98 10.15 179 65364 24798 34866590
Stevens-Johnson syndrome 106.50 10.15 152 65391 18487 34872901
Drug ineffective 100.77 10.15 478 65065 456273 34435115
Kounis syndrome 99.83 10.15 61 65482 2457 34888931
Wound closure 99.18 10.15 24 65519 52 34891336
Osteotomy 97.96 10.15 24 65519 56 34891332
Hypersensitivity 95.26 10.15 291 65252 60744 34830644
Drug abuse 90.89 10.15 36 65507 99060 34792328
Completed suicide 87.87 10.15 37 65506 98131 34793257
Toxic skin eruption 85.27 10.15 106 65437 11279 34880109
Swollen tongue 78.91 10.15 116 65427 14489 34876899
Hepatic cytolysis 78.12 10.15 115 65428 14381 34877007
Toxicity to various agents 77.76 10.15 162 65381 200200 34691188
Eyelid oedema 76.67 10.15 69 65474 5055 34886333
Tongue oedema 76.10 10.15 55 65488 2942 34888446
Off label use 75.85 10.15 469 65074 419055 34472333
Fixed eruption 74.70 10.15 44 65499 1656 34889732
Swelling face 72.37 10.15 144 65399 22961 34868427
Disease progression 66.19 10.15 63 65480 108014 34783374
Rash morbilliform 65.78 10.15 51 65492 3036 34888352
Jaundice 64.44 10.15 167 65376 31715 34859673
Enterocolitis haemorrhagic 64.06 10.15 33 65510 950 34890438
Tubulointerstitial nephritis 63.42 10.15 129 65414 20895 34870493
Tooth disorder 62.53 10.15 89 65454 10793 34880595
Hepatitis cholestatic 57.93 10.15 73 65470 7874 34883514
Crystal nephropathy 56.84 10.15 24 65519 433 34890955
Malignant neoplasm progression 56.67 10.15 49 65494 87997 34803391
Premature baby 56.32 10.15 118 65425 19515 34871873
Fall 53.37 10.15 198 65345 202687 34688701
Vesicoureteric reflux 52.42 10.15 18 65525 178 34891210
Acute psychosis 51.83 10.15 36 65507 1807 34889581
Allergy test positive 51.07 10.15 15 65528 84 34891304
Rash pruritic 50.26 10.15 137 65406 26804 34864584
Jaundice cholestatic 46.53 10.15 51 65492 4743 34886645
Urethral atresia 46.05 10.15 11 65532 22 34891366
Purpura 46.03 10.15 75 65468 10236 34881152
Helicobacter test positive 44.74 10.15 25 65518 850 34890538
Drug-induced liver injury 44.51 10.15 137 65406 28695 34862693
Hepatitis acute 43.43 10.15 62 65481 7539 34883849
Dermatitis bullous 43.34 10.15 59 65484 6863 34884525
Type IV hypersensitivity reaction 42.66 10.15 29 65514 1405 34889983
Degenerative mitral valve disease 42.53 10.15 17 65526 265 34891123
Foetal megacystis 42.42 10.15 11 65532 35 34891353
Skin test positive 41.78 10.15 18 65525 342 34891046
Symmetrical drug-related intertriginous and flexural exanthema 38.66 10.15 17 65526 340 34891048
Dermatitis exfoliative generalised 36.96 10.15 40 65503 3667 34887721
Serum sickness-like reaction 36.70 10.15 13 65530 142 34891246
Liver injury 36.52 10.15 84 65459 14794 34876594
Dyspnoea 36.23 10.15 943 64600 375839 34515549
Erythema multiforme 36.05 10.15 61 65482 8588 34882800
Mixed liver injury 35.89 10.15 35 65508 2838 34888550
Clostridium difficile colitis 35.55 10.15 86 65457 15644 34875744
Bradycardia 34.53 10.15 55 65488 75363 34816025
Tooth demineralisation 34.48 10.15 7 65536 3 34891385
Fatigue 34.41 10.15 489 65054 370164 34521224
Febrile neutropenia 34.36 10.15 136 65407 136713 34754675
Wheezing 34.13 10.15 161 65382 41241 34850147
Acute hepatic failure 34.04 10.15 79 65464 13995 34877393
Bronchospasm 33.74 10.15 67 65476 10664 34880724
Hepatitis 33.62 10.15 110 65433 23794 34867594
Cardiac failure congestive 33.36 10.15 66 65477 83204 34808184
Rash macular 33.18 10.15 74 65469 12768 34878620
Conjunctival irritation 33.05 10.15 11 65532 98 34891290
Drug eruption 33.02 10.15 97 65446 19801 34871587
Neutropenia neonatal 32.79 10.15 19 65524 693 34890695
Foetal disorder 32.72 10.15 20 65523 806 34890582
Otospondylomegaepiphyseal dysplasia 31.66 10.15 11 65532 113 34891275
Myocardial infarction 31.25 10.15 119 65424 120966 34770422
Therapeutic product effect decreased 31.21 10.15 13 65530 34730 34856658
Factitious disorder 31.01 10.15 9 65534 48 34891340
Low birth weight baby 30.65 10.15 54 65489 7851 34883537
Pulmonary vascular disorder 30.59 10.15 18 65525 676 34890712
Skin reaction 30.38 10.15 43 65500 5187 34886201
Macroglossia 30.30 10.15 15 65528 396 34890992
Nicotine dependence 29.82 10.15 17 65526 601 34890787
Eye injury 29.50 10.15 19 65524 840 34890548
Ureteric compression 29.25 10.15 13 65530 267 34891121
Laryngeal dyspnoea 29.02 10.15 10 65533 100 34891288
Malaise 28.12 10.15 497 65046 185328 34706060
Therapeutic product effect incomplete 28.05 10.15 32 65511 50509 34840879
Gingivitis 27.92 10.15 34 65509 3541 34887847
Rash vesicular 27.75 10.15 30 65513 2747 34888641
Foetal exposure during pregnancy 27.72 10.15 143 65400 37958 34853430
Cardiac aneurysm 27.58 10.15 19 65524 941 34890447
Lichen spinulosus 27.54 10.15 6 65537 6 34891382
Bone disorder 27.46 10.15 45 65498 6170 34885218
Faeces pale 27.36 10.15 22 65521 1381 34890007
Malignant mesenteric neoplasm 27.36 10.15 8 65535 44 34891344
Injection site pain 27.22 10.15 20 65523 38985 34852403
Secondary amyloidosis 27.16 10.15 9 65534 79 34891309
Ureteral disorder 27.09 10.15 11 65532 179 34891209
Laryngeal oedema 26.81 10.15 33 65510 3475 34887913
Metastases to stomach 26.58 10.15 9 65534 85 34891303
Inferior vena cava dilatation 26.57 10.15 17 65526 743 34890645
Helicobacter infection 26.48 10.15 27 65516 2310 34889078
White blood cell count decreased 26.47 10.15 91 65452 95354 34796034
Intentional product misuse 26.28 10.15 28 65515 45583 34845805
Ventricular enlargement 26.10 10.15 16 65527 648 34890740
Tooth infection 25.92 10.15 46 65497 6725 34884663
Conjunctival hyperaemia 25.86 10.15 27 65516 2375 34889013
Urethral valves 25.83 10.15 12 65531 274 34891114
Mouth swelling 25.83 10.15 24 65519 1832 34889556
Erythema annulare 25.60 10.15 8 65535 57 34891331
Agranulocytosis 25.29 10.15 100 65443 23721 34867667
Rash papular 25.19 10.15 58 65485 10220 34881168
Documented hypersensitivity to administered product 25.02 10.15 12 65531 295 34891093
Rheumatoid arthritis 24.93 10.15 21 65522 38217 34853171
Platelet count decreased 24.64 10.15 128 65415 119589 34771799
Dermatitis allergic 24.37 10.15 45 65498 6785 34884603
Urticaria papular 24.16 10.15 8 65535 70 34891318
Infective exacerbation of chronic obstructive airways disease 23.97 10.15 23 65520 1828 34889560
Penile erythema 23.91 10.15 10 65533 176 34891212
Sensitisation 23.81 10.15 10 65533 178 34891210
Ultrasound liver abnormal 23.79 10.15 9 65534 120 34891268
Vomiting 23.79 10.15 620 64923 247001 34644387
Tachycardia foetal 23.76 10.15 12 65531 331 34891057
Attention-seeking behaviour 23.71 10.15 7 65536 40 34891348
Pyrexia 23.40 10.15 802 64741 332211 34559177
Prostate cancer 23.23 10.15 24 65519 39625 34851763
Weight increased 22.99 10.15 93 65450 92940 34798448
Skin exfoliation 22.84 10.15 107 65436 27325 34864063
Cerebrovascular accident 22.76 10.15 82 65461 84729 34806659
Jejunal ulcer perforation 22.70 10.15 8 65535 86 34891302
Pyelocaliectasis 22.63 10.15 18 65525 1112 34890276
Anaemia 22.60 10.15 305 65238 233030 34658358
Heart rate decreased 22.52 10.15 16 65527 31729 34859659
Chromaturia 22.41 10.15 69 65474 14451 34876937
Drug intolerance 22.35 10.15 49 65494 59521 34831867
Henoch-Schonlein purpura 22.19 10.15 21 65522 1641 34889747
Product use issue 22.11 10.15 54 65489 63162 34828226
Cerebral infarction 22.01 10.15 12 65531 27443 34863945
Periorbital oedema 21.95 10.15 31 65512 3731 34887657
Conjunctivitis 21.87 10.15 53 65490 9652 34881736
Hypersensitivity vasculitis 21.75 10.15 29 65514 3306 34888082
Oral mucosal blistering 21.60 10.15 22 65521 1880 34889508
Toothache 21.44 10.15 41 65502 6347 34885041
Omental necrosis 20.99 10.15 6 65537 30 34891358
Cholestatic liver injury 20.97 10.15 24 65519 2340 34889048
Neuropsychiatric lupus 20.93 10.15 5 65538 10 34891378
Rash scarlatiniform 20.86 10.15 8 65535 111 34891277
Cardiac failure 20.84 10.15 94 65449 91154 34800234
Dermatomyositis 20.63 10.15 18 65525 1265 34890123
Product dose omission issue 20.38 10.15 136 65407 119575 34771813
Exposure during pregnancy 20.35 10.15 49 65494 8885 34882503
Stoma closure 20.03 10.15 10 65533 269 34891119
Occult blood 19.94 10.15 15 65528 853 34890535
Abscess oral 19.90 10.15 11 65532 366 34891022
Hyperglycaemia 19.81 10.15 27 65516 39453 34851935
Eastern Cooperative Oncology Group performance status 19.67 10.15 6 65537 39 34891349
Infusion related reaction 19.61 10.15 44 65499 53013 34838375
Liver function test abnormal 19.48 10.15 112 65431 30962 34860426
Tissue infiltration 19.40 10.15 7 65536 81 34891307
Spinal muscular atrophy 19.40 10.15 11 65532 385 34891003
Tubulointerstitial nephritis and uveitis syndrome 19.17 10.15 7 65536 84 34891304
Coagulation factor decreased 19.17 10.15 7 65536 84 34891304
Motor neurone disease 19.16 10.15 12 65531 505 34890883
Morganella infection 19.06 10.15 12 65531 510 34890878
Serum sickness 18.93 10.15 21 65522 1979 34889409
Dental operation 18.92 10.15 11 65532 404 34890984
Haemoglobin decreased 18.70 10.15 141 65402 120631 34770757
Diarrhoea haemorrhagic 18.64 10.15 40 65503 6724 34884664
Prothrombin time shortened 18.60 10.15 18 65525 1446 34889942
Sense of oppression 18.50 10.15 12 65531 537 34890851
Hallucinations, mixed 18.49 10.15 24 65519 2665 34888723
Blood creatine phosphokinase increased 18.44 10.15 35 65508 44822 34846566
Loss of personal independence in daily activities 18.42 10.15 21 65522 33158 34858230
Plica syndrome 18.36 10.15 4 65539 4 34891384
Melanocytic hyperplasia 18.36 10.15 4 65539 4 34891384
Genital cyst 18.36 10.15 4 65539 4 34891384
Infusion site induration 18.27 10.15 9 65534 235 34891153
Macule 18.06 10.15 18 65525 1499 34889889
Alveolitis 17.83 10.15 19 65524 1711 34889677
Jarisch-Herxheimer reaction 17.70 10.15 12 65531 579 34890809
Rebound acid hypersecretion 17.70 10.15 7 65536 106 34891282
Constipation 17.59 10.15 168 65375 136814 34754574
Vascular purpura 17.40 10.15 19 65524 1759 34889629
Rash pustular 17.28 10.15 34 65509 5374 34886014
Ischaemic cerebral infarction 17.11 10.15 16 65527 1231 34890157
Treatment failure 17.03 10.15 39 65504 46658 34844730
Lymphadenectomy 16.96 10.15 10 65533 377 34891011
Pharyngeal oedema 16.94 10.15 36 65507 6011 34885377
Synovitis 16.86 10.15 3 65540 14063 34877325
Foetal distress syndrome 16.83 10.15 15 65528 1085 34890303
Blindness cortical 16.82 10.15 10 65533 383 34891005
Maple syrup disease 16.75 10.15 4 65539 8 34891380
Bladder cancer 16.48 10.15 5 65538 16273 34875115
Laryngeal discomfort 16.45 10.15 8 65535 203 34891185
Pharyngitis 16.44 10.15 42 65501 7902 34883486
Exostosis of external ear canal 16.13 10.15 4 65539 10 34891378
Cheilitis 15.91 10.15 21 65522 2370 34889018
Vanishing bile duct syndrome 15.81 10.15 14 65529 1004 34890384
Dermatosis 15.77 10.15 9 65534 319 34891069
Palatal oedema 15.71 10.15 13 65530 850 34890538
Sepsis 15.64 10.15 219 65324 166342 34725046
Odynophagia 15.61 10.15 33 65510 5488 34885900
Rectal polyp 15.58 10.15 12 65531 707 34890681
Metastases to heart 15.56 10.15 7 65536 148 34891240
Bronchial disorder 15.52 10.15 16 65527 1387 34890001
COVID-19 15.34 10.15 84 65459 77466 34813922
Hospitalisation 15.27 10.15 55 65488 56847 34834541
Accessory auricle 15.13 10.15 4 65539 14 34891374
Inappropriate schedule of product administration 14.93 10.15 63 65480 62233 34829155
Periostosis 14.92 10.15 4 65539 15 34891373
Ileal perforation 14.91 10.15 12 65531 754 34890634
Sensation of foreign body 14.88 10.15 22 65521 2761 34888627
Increased bronchial secretion 14.87 10.15 18 65525 1863 34889525
Normocytic anaemia 14.70 10.15 20 65523 2324 34889064
Hypocoagulable state 14.67 10.15 13 65530 933 34890455
Genital erythema 14.64 10.15 8 65535 260 34891128
Lower respiratory tract infection bacterial 14.59 10.15 10 65533 491 34890897
Sputum increased 14.53 10.15 20 65523 2350 34889038
Pneumococcal sepsis 14.48 10.15 14 65529 1123 34890265
Gastritis 14.48 10.15 80 65463 21793 34869595
Osteonecrosis of jaw 14.32 10.15 69 65474 17820 34873568
Haematocrit decreased 14.26 10.15 24 65519 32192 34859196
Inflammatory marker increased 14.16 10.15 30 65513 4998 34886390
Lymphocyte count decreased 14.05 10.15 13 65530 22609 34868779
Blood pressure increased 14.04 10.15 102 65441 88000 34803388
Blood pressure systolic decreased 14.01 10.15 28 65515 4475 34886913
Body fat disorder 14.00 10.15 5 65538 56 34891332
Stress 14.00 10.15 22 65521 30325 34861063
Maternal drugs affecting foetus 13.99 10.15 26 65517 3939 34887449
Congenital heart valve disorder 13.92 10.15 5 65538 57 34891331
Dental caries 13.86 10.15 28 65515 4511 34886877
Depression 13.81 10.15 116 65427 96982 34794406
Neoplasm progression 13.76 10.15 14 65529 23286 34868102
Orthostatic hypotension 13.75 10.15 17 65526 25902 34865486
Pain 13.74 10.15 286 65257 204389 34686999
Cerebral haemorrhage 13.72 10.15 28 65515 34909 34856479
Tongue discolouration 13.70 10.15 14 65529 1201 34890187
Breath sounds 13.68 10.15 4 65539 22 34891366
Dermatitis exfoliative 13.64 10.15 35 65508 6604 34884784
Maternal exposure during pregnancy 13.45 10.15 29 65514 4889 34886499
Pseudomembranous colitis 13.42 10.15 21 65522 2770 34888618
Resuscitation 13.31 10.15 15 65528 1438 34889950
Neutrophil count decreased 13.31 10.15 50 65493 51054 34840334
Deep vein thrombosis 13.28 10.15 70 65473 65178 34826210
Respiratory distress 13.17 10.15 113 65430 35552 34855836
Lower respiratory tract infection 13.17 10.15 103 65440 31534 34859854
Chronic kidney disease 12.90 10.15 126 65417 41084 34850304
Pulmonary artery dilatation 12.80 10.15 7 65536 228 34891160
Tonsillitis 12.77 10.15 19 65524 2397 34888991
Sinusitis 12.68 10.15 126 65417 41276 34850112
Hypertension 12.59 10.15 180 65363 136263 34755125
Contraindicated product administered 12.58 10.15 13 65530 21468 34869920
Tonsillar erythema 12.56 10.15 3 65540 6 34891382
Skin oedema 12.54 10.15 10 65533 620 34890768
Bezoar 12.45 10.15 13 65530 1144 34890244
Hyperleukocytosis 12.43 10.15 17 65526 1985 34889403
Clostridium difficile infection 12.43 10.15 69 65474 18829 34872559
Hiatus hernia 12.42 10.15 37 65506 7608 34883780
Hypochloraemia 12.34 10.15 10 65533 635 34890753
Haematoma muscle 12.33 10.15 14 65529 1354 34890034
Respiratory tract infection 12.32 10.15 71 65472 19641 34871747
Product use in unapproved indication 12.31 10.15 151 65392 117348 34774040
Cardiac arrest 12.30 10.15 118 65425 96041 34795347
Eye swelling 12.30 10.15 44 65499 9951 34881437
Tongue eruption 12.24 10.15 3 65540 7 34891381
Cardiac hypertrophy 12.23 10.15 12 65531 980 34890408
Genital lesion 12.19 10.15 7 65536 251 34891137
Chest discomfort 12.18 10.15 156 65387 54374 34837014
Infusion site swelling 12.14 10.15 19 65524 2505 34888883
Crying 12.14 10.15 31 65512 5831 34885557
Stridor 12.09 10.15 19 65524 2515 34888873
Balanoposthitis 12.05 10.15 13 65530 1187 34890201
Lymphadenopathy 12.03 10.15 93 65450 28370 34863018
Acute respiratory failure 11.96 10.15 25 65518 30903 34860485
Papillary renal cell carcinoma 11.94 10.15 7 65536 261 34891127
Ischaemic stroke 11.92 10.15 10 65533 18240 34873148
Depressed level of consciousness 11.76 10.15 41 65502 42800 34848588
Substance-induced mood disorder 11.75 10.15 5 65538 92 34891296
Atrophic glossitis 11.70 10.15 3 65540 9 34891379
Encephalitis 11.62 10.15 35 65508 7242 34884146
Pulmonary sequestration 11.52 10.15 4 65539 41 34891347
Bronchial haemorrhage 11.51 10.15 10 65533 699 34890689
Neuroleptic malignant syndrome 11.50 10.15 10 65533 17924 34873464
Pleocytosis 11.50 10.15 9 65534 543 34890845
Dental care 11.36 10.15 7 65536 286 34891102
Senile dementia 11.35 10.15 4 65539 43 34891345
Congenital tracheomalacia 11.24 10.15 3 65540 11 34891377
Epstein-Barr virus antibody positive 11.19 10.15 7 65536 294 34891094
Factor V inhibition 11.10 10.15 6 65537 191 34891197
Myelosuppression 10.90 10.15 12 65531 19253 34872135
Cyanosis neonatal 10.90 10.15 7 65536 308 34891080
Febrile bone marrow aplasia 10.85 10.15 37 65506 8172 34883216
Red blood cell count decreased 10.85 10.15 24 65519 29066 34862322
International normalised ratio increased 10.82 10.15 136 65407 47191 34844197
Cyanosis 10.78 10.15 50 65493 12714 34878674
Band sensation 10.77 10.15 5 65538 114 34891274
Product administration error 10.62 10.15 9 65534 16335 34875053
Glycosylated haemoglobin increased 10.61 10.15 4 65539 11356 34880032
Nasal neoplasm 10.54 10.15 5 65538 120 34891268
Enamel anomaly 10.54 10.15 5 65538 120 34891268
Tooth hypoplasia 10.50 10.15 5 65538 121 34891267
Anaphylactoid reaction 10.50 10.15 17 65526 2308 34889080
Balanitis candida 10.46 10.15 5 65538 122 34891266
Dizziness exertional 10.40 10.15 6 65537 217 34891171
Muscle contractions involuntary 10.40 10.15 15 65528 1841 34889547
Mycoplasma test positive 10.39 10.15 5 65538 124 34891264
Periodontal disease 10.35 10.15 10 65533 802 34890586
Cell death 10.32 10.15 17 65526 2340 34889048
Metabolic disorder 10.31 10.15 24 65519 4259 34887129
Alveolar proteinosis 10.28 10.15 8 65535 479 34890909
Blood glucose increased 10.27 10.15 78 65465 66640 34824748

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug reaction with eosinophilia and systemic symptoms 970.42 9.63 859 144756 63385 79535388
Rash maculo-papular 917.89 9.63 785 144830 55293 79543480
Anaphylactic shock 894.87 9.63 645 144970 35351 79563422
Pruritus 849.67 9.63 2078 143537 392570 79206203
Urticaria 800.01 9.63 1306 144309 183895 79414878
Angioedema 628.30 9.63 734 144881 75301 79523472
Erythema 569.57 9.63 1258 144357 222032 79376741
Acute generalised exanthematous pustulosis 534.23 9.63 354 145261 16900 79581873
Rash 529.76 9.63 2272 143343 576086 79022687
Anaphylactic reaction 457.49 9.63 659 144956 83084 79515689
Cross sensitivity reaction 450.22 9.63 190 145425 3522 79595251
Drug hypersensitivity 437.08 9.63 1368 144247 297548 79301225
Lip oedema 434.44 9.63 218 145397 6098 79592675
Face oedema 400.41 9.63 364 145251 27772 79571001
Lip swelling 346.24 9.63 400 145215 40511 79558262
Hepatocellular injury 330.55 9.63 421 145194 47172 79551601
Type I hypersensitivity 323.82 9.63 159 145456 4239 79594534
Crystalluria 290.96 9.63 96 145519 855 79597918
Toxic skin eruption 289.34 9.63 274 145341 22019 79576754
Eosinophilia 288.25 9.63 384 145231 44961 79553812
Acute kidney injury 285.11 9.63 1770 143845 517634 79081139
Type IV hypersensitivity reaction 281.09 9.63 141 145474 3940 79594833
Cholestasis 274.19 9.63 403 145212 51706 79547067
Swelling face 266.93 9.63 472 145143 70740 79528033
Drug ineffective 262.75 9.63 1052 144563 1079861 78518912
Swollen tongue 245.63 9.63 344 145271 42226 79556547
Completed suicide 245.52 9.63 72 145543 245695 79353078
Death 231.80 9.63 426 145189 566088 79032685
Toxic epidermal necrolysis 229.10 9.63 341 145274 44240 79554533
Synovitis 222.80 9.63 13 145602 150721 79448052
Wound closure 204.41 9.63 50 145565 120 79598653
Meningitis aseptic 197.32 9.63 135 145480 6793 79591980
Stevens-Johnson syndrome 190.47 9.63 292 145323 38874 79559899
Rash erythematous 188.85 9.63 361 145254 57408 79541365
Rash pruritic 188.35 9.63 409 145206 71220 79527553
Osteotomy 180.55 9.63 50 145565 225 79598548
Tongue oedema 177.83 9.63 128 145487 6989 79591784
Jaundice 158.17 9.63 320 145295 53029 79545744
Rash macular 155.61 9.63 226 145389 28673 79570100
Enterocolitis haemorrhagic 148.75 9.63 75 145540 2119 79596654
Tubulointerstitial nephritis 145.26 9.63 255 145360 37980 79560793
Fall 143.81 9.63 436 145179 487193 79111580
Paraesthesia oral 138.81 9.63 179 145436 20292 79578481
Rash morbilliform 136.52 9.63 103 145512 6047 79592726
Pemphigus 134.64 9.63 13 145602 99569 79499204
Erythema multiforme 123.87 9.63 157 145458 17494 79581279
Hepatitis cholestatic 123.18 9.63 139 145476 13713 79585060
Eyelid oedema 119.43 9.63 136 145479 13551 79585222
Drug abuse 109.68 9.63 82 145533 162609 79436164
Hepatic cytolysis 109.57 9.63 186 145429 26965 79571808
Chronic sinusitis 109.56 9.63 127 145488 12899 79585874
Pericarditis 108.76 9.63 28 145587 104208 79494565
Fatigue 108.43 9.63 1131 144484 928596 78670177
Alopecia 105.42 9.63 162 145453 231193 79367580
Therapeutic product effect decreased 104.90 9.63 87 145528 163776 79434997
Fixed eruption 104.69 9.63 66 145549 2888 79595885
Systemic lupus erythematosus 104.67 9.63 45 145570 121104 79477669
Off label use 103.59 9.63 1109 144506 906106 78692667
Arthropathy 101.58 9.63 104 145511 177007 79421766
Toxicity to various agents 98.80 9.63 415 145200 421125 79177648
Dermatitis exfoliative generalised 97.78 9.63 91 145524 7150 79591623
Hand deformity 95.68 9.63 35 145580 103884 79494889
Duodenal ulcer perforation 94.00 9.63 7 145608 66204 79532569
Kounis syndrome 93.47 9.63 71 145544 4211 79594562
Rheumatoid arthritis 93.04 9.63 148 145467 208322 79390451
Contraindicated product administered 90.92 9.63 92 145523 157446 79441327
Skin test positive 88.09 9.63 43 145572 1131 79597642
Product use issue 87.14 9.63 156 145459 209666 79389107
Hallucinations, mixed 86.10 9.63 83 145532 6816 79591957
Drug eruption 85.27 9.63 223 145392 43712 79555061
Malaise 84.11 9.63 1308 144307 488561 79110212
Cholecystitis chronic 84.02 9.63 97 145518 9809 79588964
Dermatitis allergic 83.71 9.63 132 145483 17998 79580775
Laryngeal oedema 83.48 9.63 88 145527 8041 79590732
Purpura 83.10 9.63 137 145478 19390 79579383
Wound 82.98 9.63 55 145560 116124 79482649
Drug-induced liver injury 81.48 9.63 286 145329 65831 79532942
Infusion related reaction 81.30 9.63 188 145427 230049 79368724
Arthralgia 78.70 9.63 667 144948 571136 79027637
Bronchospasm 77.13 9.63 152 145463 24707 79574066
Clostridium difficile infection 75.15 9.63 209 145406 42476 79556297
Glossodynia 75.06 9.63 48 145567 103289 79495484
Allergy test positive 74.32 9.63 33 145582 695 79598078
Periorbital oedema 74.18 9.63 84 145531 8318 79590455
C-reactive protein abnormal 71.97 9.63 4 145611 48363 79550410
Crystal nephropathy 71.13 9.63 40 145575 1415 79597358
Dermatitis bullous 70.36 9.63 107 145508 14138 79584635
Loss of personal independence in daily activities 70.03 9.63 51 145564 102529 79496244
Clostridium difficile colitis 69.04 9.63 170 145445 32113 79566660
Injection site pain 67.05 9.63 83 145532 129755 79469018
Discomfort 66.25 9.63 79 145536 125538 79473235
Treatment failure 66.17 9.63 132 145483 170354 79428419
Hypersensitivity 65.62 9.63 750 144865 261489 79337284
Throat tightness 65.11 9.63 152 145463 27755 79571018
Febrile neutropenia 63.43 9.63 213 145402 230786 79367987
Malignant neoplasm progression 62.12 9.63 95 145520 135895 79462878
Female genital tract fistula 61.92 9.63 65 145550 5910 79592863
Agranulocytosis 61.83 9.63 202 145413 44828 79553945
Muscle injury 61.45 9.63 8 145607 48553 79550220
Abdominal discomfort 61.07 9.63 243 145372 250484 79348289
Wheezing 60.81 9.63 393 145222 116271 79482502
Hepatitis acute 60.77 9.63 105 145510 15437 79583336
Acute hepatic failure 60.65 9.63 155 145460 29958 79568815
Symmetrical drug-related intertriginous and flexural exanthema 59.22 9.63 30 145585 856 79597917
Vascular purpura 58.17 9.63 47 145568 3051 79595722
Hepatitis 57.75 9.63 228 145387 55499 79543274
Mobility decreased 57.11 9.63 84 145531 122091 79476682
Allergy to chemicals 56.48 9.63 43 145572 2559 79596214
Weight increased 54.95 9.63 290 145325 277096 79321677
Drug intolerance 54.66 9.63 272 145343 263847 79334926
Documented hypersensitivity to administered product 54.50 9.63 29 145586 918 79597855
Chromaturia 54.45 9.63 135 145480 25611 79573162
Dental operation 54.26 9.63 31 145584 1131 79597642
Intentional product use issue 53.84 9.63 124 145491 151988 79446785
Vomiting 53.74 9.63 1593 144022 664235 78934538
Psoriatic arthropathy 52.95 9.63 39 145576 77960 79520813
Mixed liver injury 52.53 9.63 67 145548 7511 79591262
Joint swelling 52.17 9.63 311 145304 288335 79310438
Folliculitis 52.08 9.63 18 145597 55362 79543411
Injection site erythema 50.67 9.63 41 145574 78156 79520617
Macular degeneration 50.44 9.63 81 145534 11215 79587558
Hyperleukocytosis 49.87 9.63 40 145575 2570 79596203
Pseudomembranous colitis 49.62 9.63 55 145560 5319 79593454
Dyspnoea 48.74 9.63 1969 143646 855056 78743717
Diarrhoea 48.73 9.63 2017 143598 878472 78720301
Stomatitis 47.73 9.63 125 145490 146632 79452141
Conjunctivitis 47.34 9.63 128 145487 25587 79573186
Serum sickness-like reaction 46.87 9.63 23 145592 612 79598161
Tongue discolouration 46.65 9.63 45 145570 3698 79595075
Disease progression 46.59 9.63 176 145439 184186 79414587
Salpingo-oophorectomy unilateral 46.48 9.63 25 145590 809 79597964
Emotional distress 45.92 9.63 169 145446 39800 79558973
Palatal oedema 45.84 9.63 30 145585 1401 79597372
Eczema 45.57 9.63 171 145444 40647 79558126
Irritable bowel syndrome 45.07 9.63 29 145586 62212 79536561
Cardiac failure congestive 44.27 9.63 124 145491 142278 79456495
Impaired healing 44.24 9.63 57 145558 87598 79511175
Skin candida 44.22 9.63 34 145581 2053 79596720
Sputum increased 43.96 9.63 48 145567 4565 79594208
Skin reaction 43.64 9.63 93 145522 15975 79582798
Tubulointerstitial nephritis and uveitis syndrome 43.49 9.63 18 145597 317 79598456
Flank pain 42.96 9.63 105 145510 19739 79579034
Abdominal pain 42.72 9.63 971 144644 388598 79210175
International normalised ratio increased 41.47 9.63 281 145334 84440 79514333
Jaundice cholestatic 41.23 9.63 74 145541 11210 79587563
Degenerative mitral valve disease 41.14 9.63 17 145598 298 79598475
General physical health deterioration 40.54 9.63 315 145300 274923 79323850
Helicobacter test positive 40.31 9.63 27 145588 1311 79597462
Bradycardia 39.98 9.63 121 145494 135436 79463337
Vaginal flatulence 39.96 9.63 35 145580 2540 79596233
Mouth swelling 39.60 9.63 52 145563 5999 79592774
Pyrexia 38.66 9.63 1560 144055 677149 78921624
Macroglossia 38.42 9.63 25 145590 1156 79597617
Pharyngeal oedema 38.36 9.63 89 145526 16183 79582590
Rash papular 38.27 9.63 107 145508 21809 79576964
Helicobacter infection 37.64 9.63 43 145572 69661 79529112
Ill-defined disorder 37.39 9.63 39 145576 65836 79532937
Lymphadenopathy 37.27 9.63 194 145421 53053 79545720
Otospondylomegaepiphyseal dysplasia 37.25 9.63 10 145605 39 79598734
Thermal burn 37.10 9.63 55 145560 7105 79591668
Dermatitis exfoliative 37.01 9.63 69 145546 10760 79588013
Tooth infection 36.96 9.63 96 145519 18736 79580037
Basilar artery occlusion 36.95 9.63 14 145601 193 79598580
Serum sickness 36.43 9.63 39 145576 3627 79595146
Sinusitis fungal 36.31 9.63 32 145583 2342 79596431
Adverse event 36.07 9.63 34 145581 60180 79538593
Macule 35.82 9.63 35 145580 2922 79595851
Myocardial infarction 35.06 9.63 195 145420 183934 79414839
Blood pressure increased 34.94 9.63 234 145381 211126 79387647
Skin exfoliation 34.68 9.63 195 145420 54905 79543868
Pain 34.56 9.63 1000 144615 702802 78895971
Injection site swelling 34.07 9.63 22 145593 47110 79551663
Platelet count decreased 33.96 9.63 212 145403 194452 79404321
Acute psychosis 33.89 9.63 40 145575 4140 79594633
Depressed level of consciousness 33.22 9.63 80 145535 96572 79502201
Condition aggravated 32.77 9.63 682 144933 500442 79098331
Henoch-Schonlein purpura 32.68 9.63 32 145583 2678 79596095
Rash pustular 32.51 9.63 67 145548 11244 79587529
Odynophagia 32.44 9.63 67 145548 11260 79587513
Dysphonia 31.74 9.63 195 145420 56677 79542096
Peripheral swelling 31.62 9.63 327 145288 269290 79329483
Therapeutic response decreased 31.20 9.63 46 145569 66807 79531966
Nasopharyngitis 30.98 9.63 305 145310 253576 79345197
Conjunctival irritation 30.95 9.63 11 145604 125 79598648
Hepatic enzyme increased 30.77 9.63 201 145414 182409 79416364
Laryngeal discomfort 30.71 9.63 17 145598 583 79598190
Oral discomfort 30.66 9.63 60 145555 9700 79589073
Cheilitis 30.55 9.63 43 145572 5298 79593475
Faeces pale 30.41 9.63 32 145583 2918 79595855
Tongue coated 30.25 9.63 23 145592 1366 79597407
Candida infection 30.12 9.63 144 145471 38070 79560703
Liver function test abnormal 29.87 9.63 211 145404 64264 79534509
Red blood cell sedimentation rate increased 29.87 9.63 24 145591 45918 79552855
Hypertension 29.85 9.63 425 145190 330567 79268206
Fluid retention 29.77 9.63 51 145564 69758 79529015
Blood pressure fluctuation 29.61 9.63 48 145567 67097 79531676
Crepitations 29.57 9.63 60 145555 9957 79588816
Ureteric compression 29.44 9.63 13 145602 270 79598503
Biliary sepsis 29.24 9.63 24 145591 1593 79597180
Rheumatic fever 29.11 9.63 8 145607 28517 79570256
Orthostatic hypotension 28.88 9.63 36 145579 56128 79542645
Eye swelling 28.81 9.63 110 145505 26358 79572415
Musculoskeletal stiffness 28.80 9.63 194 145421 174814 79423959
Vaginal discharge 28.63 9.63 50 145565 7413 79591360
Amyloid arthropathy 28.50 9.63 16 145599 564 79598209
Somatic delusion 27.87 9.63 17 145598 701 79598072
Pain in extremity 27.85 9.63 483 145132 364055 79234718
Sebaceous gland infection 27.83 9.63 11 145604 171 79598602
Rash scarlatiniform 27.83 9.63 12 145603 235 79598538
Lichen spinulosus 27.70 9.63 6 145609 6 79598767
Ventricular enlargement 27.57 9.63 17 145598 715 79598058
Contusion 27.54 9.63 159 145456 148617 79450156
Product dose omission issue 27.50 9.63 304 145311 247233 79351540
Allergy test negative 27.38 9.63 13 145602 321 79598452
Injury 27.28 9.63 238 145377 77258 79521515
Inferior vena cava dilatation 27.27 9.63 18 145597 853 79597920
Moraxella test positive 27.24 9.63 7 145608 22 79598751
Linear IgA disease 27.12 9.63 31 145584 3101 79595672
Incorrect route of product administration 27.08 9.63 15 145600 34914 79563859
Blood cholesterol increased 26.69 9.63 72 145543 83648 79515125
Infective exacerbation of chronic obstructive airways disease 26.58 9.63 29 145586 2755 79596018
Bone disorder 26.47 9.63 86 145529 19027 79579746
Malignant mesenteric neoplasm 26.31 9.63 8 145607 53 79598720
Pulmonary vascular disorder 26.29 9.63 19 145596 1044 79597729
Peritonsillar abscess 26.26 9.63 18 145597 908 79597865
Myelosuppression 26.26 9.63 21 145594 40275 79558498
Multiple sclerosis relapse 25.90 9.63 28 145587 46505 79552268
Tenosynovitis stenosans 25.87 9.63 30 145585 3048 79595725
Nicotine dependence 25.76 9.63 18 145597 937 79597836
Breast cancer 25.48 9.63 15 145600 33766 79565007
Enterocolitis 25.48 9.63 71 145544 14441 79584332
Hepatic ischaemia 25.47 9.63 19 145596 1096 79597677
Osteonecrosis of jaw 25.26 9.63 150 145465 43076 79555697
Inappropriate schedule of product administration 25.17 9.63 142 145473 133486 79465287
Drug interaction 25.14 9.63 961 144654 414222 79184551
Radiculopathy 25.04 9.63 52 145563 8772 79590001
Injection site haemorrhage 24.63 9.63 10 145605 27860 79570913
Muscle relaxant therapy 24.59 9.63 10 145605 168 79598605
Conjunctival hyperaemia 24.46 9.63 35 145580 4378 79594395
Cell death 24.21 9.63 36 145579 4663 79594110
Gait disturbance 24.18 9.63 252 145363 207254 79391519
Lip erosion 23.80 9.63 21 145594 1539 79597234
Haemolytic anaemia 23.62 9.63 79 145536 17741 79581032
Neutropenic sepsis 23.56 9.63 105 145510 26959 79571814
COVID-19 23.41 9.63 180 145435 157494 79441279
Device expulsion 23.31 9.63 9 145606 25852 79572921
Synovial fluid analysis 23.27 9.63 25 145590 2334 79596439
Anaphylactoid reaction 23.01 9.63 38 145577 5384 79593389
Knee arthroplasty 23.00 9.63 27 145588 43221 79555552
Mouth ulceration 22.93 9.63 134 145481 38260 79560513
Injection site pruritus 22.92 9.63 26 145589 42257 79556516
Procedural pain 22.75 9.63 93 145522 22991 79575782
Neoplasm progression 22.74 9.63 37 145578 51645 79547128
Cerebral infarction 22.74 9.63 30 145585 45646 79553127
Prescribed underdose 22.41 9.63 13 145602 29501 79569272
Cardiac aneurysm 22.30 9.63 20 145595 1498 79597275
Blood glucose increased 22.30 9.63 121 145494 114854 79483919
Penile erythema 22.25 9.63 9 145606 149 79598624
Excessive eye blinking 22.24 9.63 21 145594 1680 79597093
Blood alkaline phosphatase increased 22.14 9.63 195 145420 63469 79535304
Prostate cancer 22.11 9.63 17 145598 33251 79565522
Factitious disorder 22.09 9.63 9 145606 152 79598621
Sedation 22.05 9.63 38 145577 51857 79546916
Cardiac failure 21.95 9.63 179 145436 154663 79444110
Oral mucosal blistering 21.58 9.63 40 145575 6211 79592562
Normal tension glaucoma 21.55 9.63 7 145608 59 79598714
Pyelocaliectasis 21.54 9.63 16 145599 917 79597856
Fibromyalgia 21.52 9.63 54 145561 64286 79534487
Cholestatic liver injury 21.47 9.63 35 145580 4906 79593867
Pharyngeal swelling 21.34 9.63 45 145570 7674 79591099
Jarisch-Herxheimer reaction 21.18 9.63 16 145599 941 79597832
Toothache 20.92 9.63 82 145533 19888 79578885
Gamma-glutamyltransferase increased 20.87 9.63 171 145444 54509 79544264
Prescribed overdose 20.86 9.63 23 145592 37860 79560913
Bone marrow eosinophilic leukocyte count increased 20.83 9.63 6 145609 32 79598741
Ureteral disorder 20.80 9.63 13 145602 560 79598213
Proctitis 20.77 9.63 40 145575 6392 79592381
Grip strength decreased 20.75 9.63 7 145608 21862 79576911
Gallbladder disorder 20.74 9.63 80 145535 19260 79579513
Pharyngeal erythema 20.71 9.63 22 145593 2028 79596745
Scleritis 20.50 9.63 32 145583 4324 79594449
Photophobia 20.47 9.63 83 145532 20445 79578328
Rash vesicular 20.47 9.63 38 145577 5907 79592866
Localised oedema 20.42 9.63 45 145570 7907 79590866
Chest discomfort 20.41 9.63 360 145255 137684 79461089
Jejunal ulcer perforation 20.32 9.63 8 145607 123 79598650
Urticaria papular 20.25 9.63 9 145606 190 79598583
Influenza B virus test positive 20.04 9.63 11 145604 371 79598402
Haematuria 20.02 9.63 203 145412 68633 79530140
Right ventricular failure 19.85 9.63 9 145606 23488 79575285
Gingivitis 19.81 9.63 48 145567 8973 79589800
SJS-TEN overlap 19.76 9.63 14 145601 745 79598028
Product storage error 19.76 9.63 3 145612 16223 79582550
Neuroleptic malignant syndrome 19.73 9.63 13 145602 27546 79571227
Subarachnoid haemorrhage 19.71 9.63 10 145605 24455 79574318
Diabetes mellitus 19.68 9.63 75 145540 78315 79520458
Intentional product misuse 19.66 9.63 98 145517 95067 79503706
Pulmonary artery stenosis congenital 19.63 9.63 5 145610 15 79598758
Pharyngitis 19.62 9.63 87 145528 22288 79576485
Allergic hepatitis 19.57 9.63 6 145609 41 79598732
Laryngeal dyspnoea 19.56 9.63 10 145605 291 79598482
Hepatic necrosis 19.54 9.63 48 145567 9052 79589721
Spinal muscular atrophy 19.49 9.63 11 145604 392 79598381
Poisoning 19.38 9.63 11 145604 25261 79573512
Dysphagia 19.32 9.63 322 145293 121814 79476959
Stoma closure 19.31 9.63 10 145605 299 79598474
Secondary amyloidosis 19.31 9.63 9 145606 213 79598560
Urinary tract infection 19.29 9.63 369 145246 274143 79324630
Chronic kidney disease 19.20 9.63 195 145420 65959 79532814
Anaemia 19.18 9.63 643 144972 444372 79154401
Acute respiratory failure 19.13 9.63 51 145564 59490 79539283
Omental necrosis 19.09 9.63 6 145609 45 79598728
Therapeutic product effect incomplete 19.06 9.63 166 145449 141479 79457294
Lip and/or oral cavity cancer 19.05 9.63 16 145599 1097 79597676
Fracture 18.98 9.63 8 145607 21793 79576980
Lymphadenitis 18.92 9.63 32 145583 4623 79594150
Gastrointestinal disorder 18.85 9.63 138 145477 122067 79476706
Cognitive disorder 18.81 9.63 65 145550 69861 79528912
Swelling 18.56 9.63 281 145334 216430 79382343
Eastern Cooperative Oncology Group performance status 18.54 9.63 6 145609 50 79598723
Gait inability 18.53 9.63 51 145564 58866 79539907
Tooth discolouration 18.51 9.63 16 145599 1141 79597632
Tongue eruption 18.51 9.63 7 145608 96 79598677
Hiatus hernia 18.48 9.63 88 145527 23224 79575549
Prothrombin time shortened 18.48 9.63 26 145589 3202 79595571
Plica syndrome 18.47 9.63 4 145611 4 79598769
Pregnancy on oral contraceptive 18.42 9.63 14 145601 831 79597942
Injection site rash 18.38 9.63 5 145610 17949 79580824
Embolism venous 18.38 9.63 30 145585 4209 79594564
Pleural effusion 18.34 9.63 173 145442 145089 79453684
Injection site reaction 18.31 9.63 46 145569 54739 79544034
Hip arthroplasty 18.30 9.63 23 145592 35733 79563040
Pleuritic pain 18.15 9.63 50 145565 10102 79588671
Fear-related avoidance of activities 18.12 9.63 7 145608 102 79598671
Fibrous histiocytoma 18.12 9.63 13 145602 706 79598067
Oral candidiasis 18.08 9.63 104 145511 29524 79569249
Small intestinal obstruction 18.04 9.63 14 145601 27258 79571515
Therapy non-responder 17.97 9.63 97 145518 92208 79506565
Tooth disorder 17.96 9.63 95 145520 26138 79572635
Lower limb fracture 17.95 9.63 10 145605 23205 79575568
White blood cell count decreased 17.94 9.63 239 145376 188049 79410724
Abdominal wall haematoma 17.86 9.63 32 145583 4841 79593932
Hyperaemia 17.73 9.63 25 145590 3085 79595688
Gastritis 17.73 9.63 149 145466 47844 79550929
Attention-seeking behaviour 17.70 9.63 7 145608 109 79598664
Motor neurone disease 17.68 9.63 12 145603 596 79598177
Asthenia 17.49 9.63 760 144855 510929 79087844
Respiratory distress 17.43 9.63 173 145442 58166 79540607
Sensation of foreign body 17.41 9.63 34 145581 5488 79593285
Abnormal faeces 17.40 9.63 41 145574 7530 79591243
Ultrasound liver abnormal 17.37 9.63 8 145607 184 79598589
Erythema annulare 17.33 9.63 8 145607 185 79598588
Infectious mononucleosis 17.32 9.63 20 145595 2022 79596751
Underdose 17.31 9.63 21 145594 33130 79565643
Prothrombin time ratio decreased 17.30 9.63 14 145601 911 79597862
Pharyngotonsillitis 17.29 9.63 9 145606 272 79598501
Accidental exposure to product 17.26 9.63 19 145596 31303 79567470
Ureteric obstruction 17.25 9.63 23 145592 2693 79596080
Hepatic failure 17.08 9.63 179 145436 61033 79537740
Metastases to stomach 16.97 9.63 9 145606 283 79598490
Tryptase increased 16.90 9.63 12 145603 641 79598132
Mental status changes 16.85 9.63 64 145551 66895 79531878
Maple syrup disease 16.85 9.63 4 145611 8 79598765
Choluria 16.76 9.63 10 145605 396 79598377
Sedation complication 16.74 9.63 4 145611 15665 79583108
Otitis media acute 16.52 9.63 16 145599 1321 79597452
Night sweats 16.45 9.63 45 145570 52050 79546723
Bone erosion 16.44 9.63 6 145609 17841 79580932
Urinary retention 16.37 9.63 51 145564 56579 79542194
Foot fracture 16.24 9.63 10 145605 21971 79576802
Exostosis of external ear canal 16.24 9.63 4 145611 10 79598763
Tinnitus 16.04 9.63 137 145478 44196 79554577
Dysentery 16.02 9.63 15 145600 1187 79597586
Melanocytic hyperplasia 15.96 9.63 4 145611 11 79598762
Nephritis 15.86 9.63 28 145587 4186 79594587
Cardiac arrest 15.84 9.63 220 145395 171876 79426897
Obstructive airways disorder 15.78 9.63 105 145510 31354 79567419
Oxygen saturation decreased 15.74 9.63 155 145460 128892 79469881
Respiratory symptom 15.72 9.63 30 145585 4761 79594012
Bladder cancer 15.70 9.63 8 145607 19518 79579255
Somnolence 15.65 9.63 325 145290 238656 79360117
Transplant rejection 15.58 9.63 8 145607 19429 79579344
Pulmonary fibrosis 15.56 9.63 36 145579 44076 79554697
Posterior reversible encephalopathy syndrome 15.55 9.63 15 145600 26266 79572507
Skin swelling 15.54 9.63 27 145588 3987 79594786
Allergy to animal 15.53 9.63 16 145599 1423 79597350
Device malfunction 15.52 9.63 10 145605 21438 79577335
Drug dependence 15.43 9.63 32 145583 40737 79558036
Palatal swelling 15.40 9.63 7 145608 156 79598617
Injection site warmth 15.40 9.63 4 145611 14803 79583970
Premature baby 15.39 9.63 26 145589 3754 79595019
Renal tubular necrosis 15.35 9.63 88 145527 24951 79573822
Biliary dyskinesia 15.32 9.63 21 145594 2524 79596249
Oedema 15.31 9.63 305 145310 119275 79479498
Transaminases increased 15.24 9.63 153 145462 51590 79547183
Swelling of eyelid 15.23 9.63 26 145589 3785 79594988
Central nervous system lesion 15.12 9.63 3 145612 13365 79585408
Lip pain 15.05 9.63 19 145596 2108 79596665
Bipolar I disorder 15.04 9.63 19 145596 2110 79596663
Periostosis 15.03 9.63 4 145611 15 79598758
Actinomycosis 14.99 9.63 14 145601 1105 79597668
Hyperthermia 14.97 9.63 69 145546 17968 79580805
Serotonin syndrome 14.90 9.63 38 145577 44989 79553784
Budd-Chiari syndrome 14.80 9.63 6 145609 100 79598673
Hospitalisation 14.74 9.63 106 145509 94130 79504643
Polymenorrhagia 14.73 9.63 5 145610 49 79598724
PRIDE syndrome 14.63 9.63 4 145611 17 79598756
Eye pain 14.60 9.63 118 145497 37460 79561313
Inflammatory marker increased 14.58 9.63 48 145567 10692 79588081
Viral rash 14.54 9.63 9 145606 381 79598392
Vanishing bile duct syndrome 14.39 9.63 17 145598 1761 79597012
Femoral artery embolism 14.30 9.63 5 145610 54 79598719
Antinuclear antibody positive 14.25 9.63 39 145576 7851 79590922
Visual snow syndrome 14.21 9.63 5 145610 55 79598718
Labile blood pressure 14.19 9.63 19 145596 2234 79596539
Enanthema 14.11 9.63 12 145603 837 79597936
Lung neoplasm malignant 14.10 9.63 18 145597 27774 79570999
Oedema peripheral 14.09 9.63 579 145036 251709 79347064
Enamel anomaly 14.08 9.63 6 145609 114 79598659
Staphylococcal scalded skin syndrome 14.07 9.63 9 145606 404 79598369
Pneumopericardium 14.04 9.63 7 145608 193 79598580
Atelectasis 14.04 9.63 104 145511 32153 79566620
Electrocardiogram QT prolonged 13.97 9.63 102 145513 90284 79508489
Caffeine allergy 13.94 9.63 4 145611 21 79598752
Ear swelling 13.88 9.63 16 145599 1615 79597158
Ear infection 13.86 9.63 109 145506 34323 79564450
Newborn persistent pulmonary hypertension 13.85 9.63 3 145612 3 79598770
Substance-induced mood disorder 13.84 9.63 6 145609 119 79598654
Choriomeningitis lymphocytic 13.67 9.63 5 145610 62 79598711
Genital erosion 13.64 9.63 9 145606 426 79598347
Pneumococcal sepsis 13.63 9.63 16 145599 1646 79597127
Delayed delivery 13.63 9.63 4 145611 23 79598750
Creatinine renal clearance decreased 13.56 9.63 9 145606 18993 79579780
Full blood count abnormal 13.51 9.63 34 145581 40440 79558333
Alveolitis 13.50 9.63 26 145589 4154 79594619
Incision site haemorrhage 13.43 9.63 13 145602 1073 79597700
Genital erythema 13.43 9.63 8 145607 316 79598457
Drug withdrawal syndrome 13.35 9.63 27 145588 34691 79564082
Hypothyroidism 13.23 9.63 50 145565 52342 79546431
Dermatosis 13.15 9.63 10 145605 594 79598179
Deformity 13.10 9.63 43 145572 9562 79589211
Heart rate decreased 13.09 9.63 75 145540 70241 79528532
Eosinophils urine present 13.00 9.63 5 145610 72 79598701
Tonsillitis 12.94 9.63 34 145581 6680 79592093
Lower respiratory tract infection bacterial 12.88 9.63 12 145603 944 79597829
Target skin lesion 12.79 9.63 6 145609 144 79598629
Therapy partial responder 12.74 9.63 8 145607 17389 79581384
Balanoposthitis 12.73 9.63 12 145603 958 79597815
Forced vital capacity abnormal 12.72 9.63 4 145611 30 79598743
Sciatica 12.64 9.63 26 145589 33196 79565577
Body fat disorder 12.62 9.63 7 145608 241 79598532
Prurigo 12.62 9.63 14 145601 1355 79597418
Sepsis 12.62 9.63 385 145230 269043 79329730
Glycosylated haemoglobin increased 12.60 9.63 10 145605 19250 79579523
Reaction to excipient 12.54 9.63 15 145600 1574 79597199
Myalgia 12.50 9.63 435 145180 185206 79413567
Femur fracture 12.50 9.63 33 145582 38619 79560154
Cholestasis of pregnancy 12.49 9.63 12 145603 981 79597792
Musculoskeletal pain 12.45 9.63 123 145492 102231 79496542
Hypoaesthesia oral 12.45 9.63 55 145560 14069 79584704
Parotid gland enlargement 12.44 9.63 12 145603 986 79597787
Pericardial effusion 12.42 9.63 43 145572 46194 79552579
Eye oedema 12.39 9.63 17 145598 2046 79596727
Anhedonia 12.37 9.63 57 145558 14841 79583932
Disability 12.36 9.63 8 145607 17112 79581661
Enthesopathy 12.33 9.63 3 145612 11605 79587168
Nail dystrophy 12.29 9.63 12 145603 1001 79597772
Lip ulceration 12.25 9.63 18 145597 2307 79596466
Interstitial lung disease 12.21 9.63 139 145476 112461 79486312
Clostridium colitis 12.19 9.63 20 145595 2819 79595954
Normocytic anaemia 12.18 9.63 25 145590 4182 79594591
Campylobacter infection 12.18 9.63 16 145599 1847 79596926
Ileal perforation 12.17 9.63 12 145603 1013 79597760
Lung consolidation 12.16 9.63 40 145575 8907 79589866
Type III immune complex mediated reaction 12.13 9.63 10 145605 668 79598105
Nasal polyps 12.04 9.63 35 145580 7292 79591481
Respiratory arrest 12.04 9.63 59 145556 57491 79541282
Genital lesion 12.01 9.63 9 145606 523 79598250
Papillary renal cell carcinoma 11.95 9.63 7 145608 268 79598505
Allergy to arthropod bite 11.92 9.63 7 145608 269 79598504
Periorbital swelling 11.89 9.63 20 145595 2876 79595897
Eye injury 11.86 9.63 19 145596 2624 79596149
Pharyngeal abscess 11.85 9.63 10 145605 690 79598083
Respiratory tract oedema 11.83 9.63 11 145604 863 79597910
Nail infection 11.82 9.63 18 145597 2381 79596392
Analgesic drug level increased 11.81 9.63 21 145594 3157 79595616
Papule 11.80 9.63 35 145580 7372 79591401
Atrial septal defect 11.78 9.63 16 145599 1906 79596867
Pneumonia mycoplasmal 11.75 9.63 14 145601 1464 79597309
Pulmonary mass 11.67 9.63 22 145593 29012 79569761
Renal failure 11.62 9.63 463 145152 200505 79398268
Occult blood 11.57 9.63 15 145600 1708 79597065
Idiopathic urticaria 11.57 9.63 6 145609 180 79598593
Cerebral haemorrhage 11.56 9.63 60 145555 57613 79541160
Respiratory failure 11.55 9.63 247 145368 180664 79418109
Chapped lips 11.53 9.63 18 145597 2432 79596341
Tympanic membrane perforation 11.53 9.63 15 145600 1715 79597058
Systolic dysfunction 11.52 9.63 23 145592 3772 79595001
Eosinophilic pneumonia acute 11.48 9.63 12 145603 1086 79597687
Tongue pruritus 11.46 9.63 9 145606 561 79598212
Therapy cessation 11.45 9.63 33 145582 37529 79561244
Renal cancer 11.45 9.63 4 145611 12222 79586551
Hypoaesthesia 11.42 9.63 245 145370 179107 79419666
Circulatory collapse 11.39 9.63 112 145503 37556 79561217
Antibiotic level above therapeutic 11.37 9.63 10 145605 730 79598043
Abnormal behaviour 11.37 9.63 109 145506 36312 79562461
Herpes simplex test positive 11.36 9.63 8 145607 422 79598351
Metastases to central nervous system 11.36 9.63 8 145607 16367 79582406
Cardio-respiratory arrest 11.36 9.63 135 145480 108375 79490398
Pseudomyopia 11.27 9.63 5 145610 105 79598668
Medication error 11.23 9.63 182 145433 68460 79530313
Morganella infection 11.22 9.63 12 145603 1115 79597658
Ocular hyperaemia 11.19 9.63 89 145526 28117 79570656
Encephalitis 11.19 9.63 55 145560 14705 79584068
Device leakage 11.16 9.63 3 145612 10853 79587920
Personal relationship issue 11.16 9.63 6 145609 194 79598579
Vertebrobasilar insufficiency 11.15 9.63 7 145608 304 79598469
Petechiae 11.15 9.63 70 145545 20495 79578278
Electrocardiogram QRS complex prolonged 11.12 9.63 3 145612 10830 79587943
Quality of life decreased 11.09 9.63 43 145572 10377 79588396
Lower gastrointestinal haemorrhage 11.02 9.63 8 145607 16117 79582656
Dyspepsia 10.98 9.63 268 145347 108419 79490354
Progressive multifocal leukoencephalopathy 10.81 9.63 13 145602 20587 79578186
Mycoplasma test positive 10.78 9.63 6 145609 208 79598565
Post-traumatic stress disorder 10.75 9.63 26 145589 4855 79593918
Suspected suicide 10.73 9.63 3 145612 10573 79588200
Injection site urticaria 10.70 9.63 5 145610 12821 79585952
Mucosal discolouration 10.67 9.63 10 145605 793 79597980
Blood pressure systolic increased 10.64 9.63 75 145540 66911 79531862
Balanitis candida 10.62 9.63 5 145610 121 79598652
Oropharyngeal discomfort 10.61 9.63 33 145582 7133 79591640
Blood test abnormal 10.60 9.63 10 145605 17700 79581073
Type 2 diabetes mellitus 10.59 9.63 61 145554 57061 79541712
Tendon disorder 10.56 9.63 33 145582 7153 79591620
Unevaluable event 10.50 9.63 59 145556 55526 79543247
Injection site bruising 10.44 9.63 39 145576 40963 79557810
Biliary tract disorder 10.43 9.63 14 145601 1650 79597123
Coagulation factor decreased 10.43 9.63 6 145609 222 79598551
Ascites 10.41 9.63 88 145527 75474 79523299
Resuscitation 10.41 9.63 17 145598 2387 79596386
Acquired haemophilia 10.36 9.63 15 145600 1896 79596877
Eosinophilic pneumonia 10.35 9.63 27 145588 5283 79593490
Post transplant lymphoproliferative disorder 10.31 9.63 4 145611 11460 79587313
Injection site mass 10.31 9.63 13 145602 20171 79578602
Genital cyst 10.31 9.63 4 145611 59 79598714
Hypersensitivity vasculitis 10.31 9.63 32 145583 6911 79591862
Intestinal obstruction 10.26 9.63 42 145573 42978 79555795
Tonsillar erythema 10.26 9.63 3 145612 17 79598756
Atrioventricular block first degree 10.22 9.63 5 145610 12486 79586287
Kidney transplant rejection 10.22 9.63 3 145612 10243 79588530
Hypoxia 10.22 9.63 130 145485 103113 79495660
Pharyngeal paraesthesia 10.14 9.63 18 145597 2703 79596070
Loefgren syndrome 10.06 9.63 5 145610 137 79598636
Herpes zoster 10.05 9.63 115 145500 92968 79505805
Pulmonary pain 10.04 9.63 24 145591 4449 79594324
Bronchial disorder 9.97 9.63 17 145598 2472 79596301
Bleeding time prolonged 9.96 9.63 12 145603 1269 79597504
Leukocyturia 9.94 9.63 15 145600 1968 79596805
Blood pressure abnormal 9.93 9.63 10 145605 17159 79581614
Coagulopathy 9.91 9.63 105 145510 35901 79562872
Oedema mouth 9.88 9.63 19 145596 3032 79595741
Migraine 9.88 9.63 107 145508 87386 79511387
Deafness 9.83 9.63 69 145546 20968 79577805
Uterine contractions abnormal 9.83 9.63 5 145610 144 79598629
Cushingoid 9.83 9.63 39 145576 9513 79589260
Arthritis 9.82 9.63 149 145466 114731 79484042
Delirium 9.76 9.63 103 145512 84524 79514249
Tenosynovitis 9.75 9.63 55 145560 15499 79583274
Hepatorenal syndrome 9.75 9.63 23 145592 4226 79594547
Ischaemic cerebral infarction 9.74 9.63 17 145598 2518 79596255
Diffuse large B-cell lymphoma 9.74 9.63 5 145610 12144 79586629
Biliary colic 9.70 9.63 22 145593 3940 79594833
Penile blister 9.69 9.63 4 145611 70 79598703
Pharyngitis streptococcal 9.65 9.63 42 145573 10672 79588101
Hyperglycaemia 9.65 9.63 82 145533 70253 79528520
Renal colic 9.65 9.63 18 145597 2809 79595964

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A02BD01 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD03 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD04 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD05 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD06 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD07 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD10 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD11 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD12 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD13 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD14 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD15 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD16 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC J01CA04 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
BETA-LACTAM ANTIBACTERIALS, PENICILLINS
Penicillins with extended spectrum
ATC J01CR02 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
BETA-LACTAM ANTIBACTERIALS, PENICILLINS
Combinations of penicillins, incl. beta-lactamase inhibitors
FDA CS M0016152 Penicillins
FDA EPC N0000175497 Penicillin-class Antibacterial
CHEBI has role CHEBI:36047 antibacterial drugs
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents

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

DiseaseRelationSNOMED_IDDOID
Acute otitis media indication 3110003
Staphylococcal tonsillitis indication 11461005
Haemophilus Influenzae Acute Otitis Media indication 19021002
Infection of skin AND/OR subcutaneous tissue indication 19824006
Pneumonia due to Streptococcus indication 34020007
Streptococcal tonsillitis indication 41582007
Lower respiratory tract infection indication 50417007
Bacterial pneumonia indication 53084003 DOID:874
Klebsiella cystitis indication 60867007
Pneumonia due to Klebsiella pneumoniae indication 64479007
Urinary tract infectious disease indication 68566005
Haemophilus influenzae pneumonia indication 70036007
Infection due to Escherichia coli indication 71057007
Rhinoscleroma indication 72409005 DOID:11336
Acute bacterial sinusitis indication 75498004
Staphylococcal pharyngitis indication 82228008
Pneumococcal pneumonia indication 233607000
Escherichia coli urinary tract infection indication 301011002
Streptococcus pyogenes infection indication 302809008
Bacterial urinary infection indication 312124009
Infective otitis media indication 312218008
Pharyngitis indication 405737000 DOID:2275
Infection due to Staphylococcus aureus indication 406602003
Acute exacerbation of chronic bronchitis indication 425748003
Pneumonia due to Staphylococcus aureus indication 441658007
Moraxella Catarrhalis Acute Otitis Media indication 703469002
Infection caused by Helicobacter pylori indication 721730009
Streptococcus Pneumoniae Chronic Bronchitis indication
Duodenal Ulcer due to H. Pylori indication
Haemophilus Influenzae Chronic Bronchitis indication
Pneumococcal Acute Otitis Media indication
Haemophilus Parainfluenzae Pneumonia indication
Skin and Skin Structure Streptococcus Infection indication
Genitourinary Tract Infection due to Proteus indication
Tonsillitis due to Haemophilus Influenzae indication
Enterococcus Genitourinary Tract Infection indication
Moraxella Catarrhalis Pneumonia indication
E. Coli Genitourinary Tract Infection indication
Genitourinary Tract Infections indication
Haemophilus Influenzae Pharyngitis indication
Typhoid fever off-label use 4834000 DOID:13258
Pyrexia of unknown origin off-label use 7520000
Lyme disease off-label use 23502006 DOID:11729
Chronic purulent otitis media off-label use 38394007 DOID:14247
Cholangitis off-label use 82403002 DOID:9446
Human bite - wound off-label use 262555007
Chancroid off-label use 266143009 DOID:13778
Diverticulitis of gastrointestinal tract off-label use 271366000
Dog bite - wound off-label use 283734005
Cat bite - wound off-label use 283782004
Prevention of Neonatal Group B Streptococcal Infection off-label use
Diabetic Foot Infection off-label use
Prevention of Bacterial Endocarditis off-label use
Ventricular tachycardia contraindication 25569003
Obstruction of bile duct contraindication 30144000
Torsades de pointes contraindication 31722008
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Osteoporosis contraindication 64859006 DOID:11476
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Cholestatic hepatitis contraindication 95556007
Prolonged QT interval contraindication 111975006
Fracture of bone contraindication 125605004
Liver function tests abnormal contraindication 166603001
Hypomagnesemia contraindication 190855004
Disease of liver contraindication 235856003 DOID:409
Infectious mononucleosis contraindication 271558008 DOID:8568
Pseudomembranous enterocolitis contraindication 397683000
Porphyria contraindication 418470004




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Cats Upper respiratory tract infections caused by Staphylococcus aureus Indication
Cats Upper respiratory tract infections caused by Streptococcus spp Indication
Cats Upper respiratory tract infections caused by Escherichia coli Indication
Cats Gastrointestinal tract infections caused by Escherichia coli Indication
Cats Genitourinary tract infections caused by Staphylococcus aureus Indication
Cats Genitourinary tract infections caused by Streptococcus spp Indication
Cats Genitourinary tract infections caused by Escherichia coli Indication
Cats Genitourinary tract infections caused by Proteus species Indication
Cats Skin and soft tissue infections caused by Staphylococcus spp Indication
Cats Skin and soft tissue infections caused by Streptococcus spp Indication
Cats Skin and soft tissue infections caused by Escherichia coli Indication
Cats Skin and soft tissue infectionscaused by Pasteurella multocida Indication
Cattle Bacterial enteritis caused by susceptible Escherichia coli Indication
Cattle Respiratory tract infections caused by Pasteurella multocida Indication
Cattle Respiratory tract infections caused by P hemolytica Indication
Cattle Respiratory tract infections caused by Hemophilus species Indication
Cattle Respiratory tract infections caused by Staphylococci species Indication
Cattle Respiratory tract infections caused by Streptococci species and Indication
Cattle Necrotic pododermatitis (foot rot) caused by Fusobacterium necrophorum Indication
Cattle Bovine mastitis caused by Streptococcus agalactiae Indication
Cattle Bovine mastitis caused by Staphylococcus aureus Indication
Dogs Respiratory tract infection caused by Staphylococcus aureus Indication
Dogs Respiratory tract infections caused by Streptococcus spp Indication
Dogs Respiratory tract infections caused by Escherichia coli Indication
Dogs Respiratory tract infections caused by Proteus mirabilis Indication
Dogs Urinary tract infections caused by Staphylococcus aureus Indication
Dogs Urinary tract infections caused by Streptococcus spp Indication
Dogs Urinary tract infections caused by Escherichia coli Indication
Dogs Urinary tract infections caused by Proteus mirabilis Indication
Dogs Soft tissue infections caused by Staphylococcus aureus Indication
Dogs Soft tissue infections caused by Streptococcus spp Indication
Dogs Soft tissue infections caused by Escherichia coli Indication
Dogs Soft tissue infections caused by Proteus mirabilis Indication
Dogs Bacterial dermatitis caused by Staphylococcus aureus Indication
Dogs Bacterial dermatitis caused by Streptococcus spp Indication
Dogs Bacterial dermatitis caused by Proteus mirabilis Indication
Swine PorcinEscherichia colibacillosis caused by Escherichia coli Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Amoxi-Tabs Zoetis Inc. 1
Amoxi-Doser Zoetis Inc. 1
Amoxi-Tabs Zoetis Inc. 1
Amoxi-Drop Oral Suspension Zoetis Inc. 1
Amoxi-Bol Zoetis Inc. 1
Amoxi-Sol Zoetis Inc. 1
Amoxi-Inject (Cattle) Zoetis Inc. 1
Amoxi-Inject (Dogs and Cats) Zoetis Inc. 1
CLAVAMOX CHEWABLE Tablets, CLAVAMOX tablets Zoetis Inc. 2
CLAVAMOX CHEWABLE Tablets, CLAVAMOX tablets Zoetis Inc. 2
Amoxi-Mast Intervet Inc. 1
Clavamox Drops Zoetis Inc. 2
Biomox, Robamox-V Tablets Virbac AH Inc. 1
Biomox, Robamox-V Virbac AH Inc. 1
Robamox-V Zoetis Inc. 1
Robamox-V Tablets Zoetis Inc. 1
Clavacillin Dechra Veterinary Products LLC 2
Amoxicillin and Clavulanate Potassium for Oral Suspension Dechra Veterinary Products LLC 2
Amoxicillin and Clavulanate Potassium Tablets Cronus Pharma Specialities India Private Limited 2
Amoxicillin and Clavulanate Potassium for Oral Suspension Cronus Pharma Specialities India Private Limited 2

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.79 acidic
pKa2 9.72 acidic
pKa3 7.63 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
775MG MOXATAG PRAGMA N050813 Jan. 23, 2008 DISCN TABLET, EXTENDED RELEASE ORAL 8778924 Dec. 8, 2026 METHOD OF TREATING TONSILLITIS AND/OR PHARYNGITIS SECONDARY TO STREPTOCOCCUS PYOGENES IN A ONCE-A-DAY AMOXICILLIN PRODUCT
775MG MOXATAG PRAGMA N050813 Jan. 23, 2008 DISCN TABLET, EXTENDED RELEASE ORAL 8299052 May 7, 2027 USE OF ONCE-A-DAY AMOXICILLIN PRODUCT TO TREAT TONSILLITIS AND/OR PHARYNGITIS SECONDARY TO STREPTOCOCCUS PYOGENES
250MG;EQ 10MG BASE;12.5MG TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 11135172 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS
250MG;EQ 10MG BASE;12.5MG TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 9050263 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS
250MG;EQ 10MG BASE;12.5MG TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 9498445 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS
250MG;EQ 10MG BASE;12.5MG TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 9603806 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
500MG;500MG;EQ 20MG BASE VOQUEZNA TRIPLE PAK PHATHOM N215152 May 3, 2022 DISCN CAPSULE, TABLET, TABLET ORAL May 3, 2027 NEW CHEMICAL ENTITY
500MG;EQ 20MG BASE VOQUEZNA DUAL PAK PHATHOM N215153 May 3, 2022 DISCN CAPSULE, TABLET ORAL May 3, 2027 NEW CHEMICAL ENTITY
500MG;500MG;EQ 20MG BASE VOQUEZNA TRIPLE PAK PHATHOM N215152 May 3, 2022 DISCN CAPSULE, TABLET, TABLET ORAL May 3, 2032 GENERATING ANTIBIOTIC INCENTIVES NOW
500MG;EQ 20MG BASE VOQUEZNA DUAL PAK PHATHOM N215153 May 3, 2022 DISCN CAPSULE, TABLET ORAL May 3, 2032 GENERATING ANTIBIOTIC INCENTIVES NOW

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
5-hydroxytryptamine receptor 2A GPCR IC50 6.22 WOMBAT-PK
5-hydroxytryptamine receptor 2B GPCR IC50 5.96 WOMBAT-PK
5-hydroxytryptamine receptor 2C GPCR IC50 5.80 WOMBAT-PK
Bacterial penicillin-binding protein Enzyme INHIBITOR CHEMBL CHEMBL
Penicillin-binding protein 1A Enzyme WOMBAT-PK

External reference:

IDSource
4017605 VUID
N0000145985 NUI
D00229 KEGG_DRUG
34642-77-8 SECONDARY_CAS_RN
1297882 RXNORM
C0002645 UMLSCUI
CHEBI:2676 CHEBI
CHEMBL1082 ChEMBL_ID
DB01060 DRUGBANK_ID
CHEMBL2105950 ChEMBL_ID
D000658 MESH_DESCRIPTOR_UI
33613 PUBCHEM_CID
10895 IUPHAR_LIGAND_ID
804826J2HU UNII
11786 MMSL
3600 MMSL
4187 MMSL
d00088 MMSL
27658006 SNOMEDCT_US
372687004 SNOMEDCT_US
427483001 SNOMEDCT_US
785686003 SNOMEDCT_US
96068000 SNOMEDCT_US
AXL PDB_CHEM_ID
4017604 VANDF
4017605 VANDF
3230 INN_ID
61336-70-7 SECONDARY_CAS_RN
002707 NDDF
003675 NDDF
003718 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2263 TABLET, FILM COATED 500 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2263 TABLET, FILM COATED 500 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2263 TABLET, FILM COATED 500 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2264 TABLET, FILM COATED 875 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2264 TABLET, FILM COATED 875 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2264 TABLET, FILM COATED 875 mg ORAL ANDA 26 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2267 TABLET, CHEWABLE 125 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2267 TABLET, CHEWABLE 125 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2267 TABLET, CHEWABLE 125 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2268 TABLET, CHEWABLE 250 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2268 TABLET, CHEWABLE 250 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2268 TABLET, CHEWABLE 250 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2270 TABLET, CHEWABLE 200 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2270 TABLET, CHEWABLE 200 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2270 TABLET, CHEWABLE 200 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2272 TABLET, CHEWABLE 400 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2272 TABLET, CHEWABLE 400 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2272 TABLET, CHEWABLE 400 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2274 TABLET, FILM COATED 500 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2274 TABLET, FILM COATED 500 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2274 TABLET, FILM COATED 500 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2275 TABLET, FILM COATED 875 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2275 TABLET, FILM COATED 875 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2275 TABLET, FILM COATED 875 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2277 POWDER, FOR SUSPENSION 200 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2277 POWDER, FOR SUSPENSION 200 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2277 POWDER, FOR SUSPENSION 200 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2279 POWDER, FOR SUSPENSION 400 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2279 POWDER, FOR SUSPENSION 400 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2279 POWDER, FOR SUSPENSION 400 mg ORAL ANDA 27 sections