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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -1.739 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.327 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.456 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 1.245 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 82.120 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 67.830 % High 1
herg hERG pIC50 4.534 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.239 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.516 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 76.930 % High 1
kinase-safety-class ACVR2A,ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,ERBB2,GRK2,GRK3,GSK3B,ITK,JAK2,JAK3,KDR,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PIK3CB,PIM2,PRKDC,SIK2,STK33,SYK,TEK,TGFBR1,ZAP70 41
kinase-selectivity-class ACVR2B,AXL,CDK9,GRK2,MAP2K6,TEK,TGFBR1 7
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.438 High 0.85
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.451 High 1
mh-clint Mouse hepatocyte intrinsic clearance 2.831 High 1
mppb Mouse plasma protein binding (% unbound) 84.960 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.153 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 77.010 % High 1
rat-kpuu-brain Rat brain Kpuu 0.007 % High 0.85
rh-clint Rat hepatocyte intrinsic clearance 1.384 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 86.910 % High 1
rppb Rat plasma protein binding (% unbound) 72.320 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 903.649 uM High 1

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
Rash maculo-papular 883.59 9.56 614 130219 40319 90457295
Angioedema 815.20 9.56 706 130127 64170 90433444
Drug hypersensitivity 761.82 9.56 1904 128929 461705 90035909
Anaphylactic shock 635.23 9.56 454 130379 31163 90466451
Drug reaction with eosinophilia and systemic symptoms 614.71 9.56 503 130330 42255 90455359
Erythema 596.01 9.56 1134 129699 228112 90269502
Swelling face 485.53 9.56 593 130240 80759 90416855
Macular degeneration 448.29 9.56 399 130434 37571 90460043
Acute generalised exanthematous pustulosis 442.68 9.56 265 130568 13438 90484176
Anaphylactic reaction 431.04 9.56 580 130253 86944 90410670
Pemphigus 416.62 9.56 12 130821 326852 90170762
Pruritus 407.20 9.56 1702 129131 539823 89957791
Swollen tongue 405.36 9.56 411 130422 45545 90452069
Type I hypersensitivity 368.20 9.56 159 130674 3996 90493618
Synovitis 363.87 9.56 30 130803 329722 90167892
Face oedema 353.43 9.56 283 130550 23035 90474579
Cross sensitivity reaction 343.61 9.56 136 130697 2721 90494893
Toxic skin eruption 341.13 9.56 237 130596 15537 90482077
Lip swelling 325.45 9.56 337 130496 38273 90459341
Pericarditis 320.27 9.56 17 130816 270134 90227480
Urticaria 310.60 9.56 1075 129758 311659 90185955
Acute kidney injury 304.13 9.56 1085 129748 319302 90178312
Lip oedema 301.52 9.56 143 130690 4496 90493118
Hand deformity 293.62 9.56 40 130793 296322 90201292
Systemic lupus erythematosus 293.07 9.56 80 130753 361816 90135798
Glossodynia 292.82 9.56 55 130778 321724 90175890
Chronic sinusitis 290.65 9.56 255 130578 23547 90474067
Type IV hypersensitivity reaction 282.99 9.56 130 130703 3796 90493818
Paraesthesia oral 278.91 9.56 283 130550 31376 90466238
Alopecia 259.73 9.56 201 130632 494870 90002744
Abortion spontaneous 244.62 9.56 344 130489 53712 90443902
Toxic epidermal necrolysis 244.19 9.56 267 130566 32261 90465353
Duodenal ulcer perforation 241.63 9.56 21 130812 221267 90276347
Wound 236 9.56 72 130761 302908 90194706
Hepatocellular injury 224.90 9.56 242 130591 28716 90468898
Rash 220.56 9.56 1927 128906 794173 89703441
Arthropathy 219.77 9.56 128 130705 366114 90131500
Crystalluria 212.02 9.56 63 130770 499 90497115
Muscle injury 209.67 9.56 11 130822 176643 90320971
Hepatic enzyme increased 204.08 9.56 135 130698 360601 90137013
Female genital tract fistula 199.49 9.56 182 130651 17686 90479928
Eosinophilia 196.65 9.56 224 130609 28309 90469305
Folliculitis 189.98 9.56 33 130800 204320 90293294
Psoriatic arthropathy 185.63 9.56 50 130783 228285 90269329
Rheumatic fever 183.41 9.56 9 130824 153112 90344502
Helicobacter infection 180.09 9.56 52 130781 226798 90270816
Irritable bowel syndrome 179.21 9.56 40 130793 207408 90290206
Allergy test positive 174.60 9.56 58 130775 684 90496930
Therapeutic product effect decreased 173.70 9.56 92 130741 277479 90220135
Mobility decreased 172.41 9.56 73 130760 250661 90246953
Discomfort 171.56 9.56 91 130742 274244 90223370
Vaginal flatulence 169.74 9.56 143 130690 12495 90485119
Dysphonia 169.65 9.56 317 130516 62767 90434847
Abdominal discomfort 168.67 9.56 268 130565 477060 90020554
Stevens-Johnson syndrome 166.87 9.56 209 130624 29167 90468447
Tongue oedema 157.01 9.56 98 130735 5356 90492258
Radiculopathy 156.77 9.56 162 130671 18343 90479271
Sleep disorder due to general medical condition, insomnia type 155.96 9.56 7 130826 128687 90368927
Rash pruritic 151.76 9.56 354 130479 81860 90415754
Vaginal discharge 151.73 9.56 163 130670 19301 90478313
Proctitis 150.33 9.56 145 130688 15114 90482500
Stomatitis 149.71 9.56 107 130726 274591 90223023
Product use issue 147.67 9.56 155 130678 329764 90167850
Ill-defined disorder 147.44 9.56 42 130791 184849 90312765
Contraindicated product administered 147.16 9.56 147 130686 319992 90177622
Hepatic cytolysis 144.70 9.56 200 130633 30716 90466898
Rash erythematous 144.67 9.56 302 130531 64802 90432812
Cholestasis 143.85 9.56 217 130616 36082 90461532
Blood cholesterol increased 142.28 9.56 61 130772 207951 90289663
Impaired healing 140.18 9.56 82 130751 234117 90263497
Type 2 diabetes mellitus 139.98 9.56 59 130774 203185 90294429
Jaundice 139.82 9.56 202 130631 32315 90465299
Fibromyalgia 138.70 9.56 62 130771 206207 90291407
Cholecystitis chronic 135.72 9.56 113 130720 9713 90487901
Meningitis aseptic 135.38 9.56 97 130736 6676 90490938
Joint swelling 132.03 9.56 336 130497 502964 89994650
Arthralgia 129.58 9.56 631 130202 777891 89719723
Tubulointerstitial nephritis 127.80 9.56 170 130663 25173 90472441
Oral candidiasis 123.85 9.56 200 130633 35255 90462359
Treatment failure 123.83 9.56 154 130679 303774 90193840
Rash macular 122.82 9.56 183 130650 30097 90467517
C-reactive protein abnormal 121.93 9.56 19 130814 127410 90370204
White blood cell count abnormal 119.97 9.56 94 130739 7410 90490204
Erythema multiforme 119.94 9.56 116 130717 12130 90485484
Swelling 118.38 9.56 269 130564 418789 90078825
Infusion related reaction 110.21 9.56 277 130556 416503 90081111
Procedural pain 106.87 9.56 181 130652 33179 90464435
Drug eruption 105.44 9.56 186 130647 35221 90462393
Breast cancer stage III 104.30 9.56 4 130829 84443 90413171
Lip dry 103.85 9.56 12 130821 100943 90396671
Rash morbilliform 102.58 9.56 67 130766 3962 90493652
Abdominal pain 101.94 9.56 944 129889 394777 90102837
Blister 100.95 9.56 132 130701 254866 90242748
Intentional product use issue 100.29 9.56 99 130734 216793 90280821
Hepatitis cholestatic 99.09 9.56 89 130744 8472 90489142
Skin test positive 98.39 9.56 40 130793 860 90496754
Emotional distress 98.26 9.56 184 130649 36478 90461136
Dermatitis allergic 97.96 9.56 123 130710 17204 90480410
Wound closure 97.37 9.56 26 130807 132 90497482
Gastrointestinal disorder 96.46 9.56 138 130695 256549 90241065
Prescribed overdose 94.67 9.56 14 130819 97611 90400003
Death 94.43 9.56 340 130493 456211 90041403
Peripheral venous disease 94.24 9.56 7 130826 83914 90413700
Fatigue 93.40 9.56 1143 129690 1152880 89344734
Hallucinations, mixed 92.48 9.56 73 130760 5816 90491798
Gait inability 92.36 9.56 48 130785 146408 90351206
Linear IgA disease 92.19 9.56 51 130782 2223 90495391
Enterocolitis haemorrhagic 90.47 9.56 46 130787 1686 90495928
General physical health deterioration 89.27 9.56 242 130591 354873 90142741
Flank pain 87.93 9.56 123 130710 19099 90478515
Allergy test negative 86.94 9.56 26 130807 211 90497403
Grip strength decreased 85.89 9.56 15 130818 92561 90405053
Thermal burn 85.67 9.56 74 130759 6688 90490926
Dermatitis exfoliative generalised 84.99 9.56 68 130765 5525 90492089
Hypercholesterolaemia 84.04 9.56 21 130812 100871 90396743
Joint range of motion decreased 83.27 9.56 46 130787 135597 90362017
Amyloid arthropathy 83.07 9.56 43 130790 1637 90495977
Lower limb fracture 82.87 9.56 12 130821 85001 90412613
Fall 82.62 9.56 386 130447 481424 90016190
Mixed liver injury 81.88 9.56 76 130757 7547 90490067
Wound infection 81.48 9.56 26 130807 106376 90391238
Osteotomy 81.25 9.56 26 130807 270 90497344
Palatal oedema 80.53 9.56 32 130801 647 90496967
Drug ineffective 79.95 9.56 1464 129369 1382834 89114780
Facet joint syndrome 79.06 9.56 22 130811 98367 90399247
Laryngeal oedema 78.59 9.56 71 130762 6810 90490804
Acute hepatic failure 77.07 9.56 126 130707 22435 90475179
Adverse event 76.26 9.56 37 130796 117381 90380233
Eyelid oedema 75.18 9.56 88 130745 11446 90486168
Nasopharyngitis 73.45 9.56 320 130513 406784 90090830
Weight increased 73.30 9.56 332 130501 417595 90080019
Completed suicide 73.26 9.56 61 130772 144997 90352617
Rash papular 72.69 9.56 116 130717 20239 90477375
Clostridium difficile infection 71.20 9.56 160 130673 36085 90461529
Prescribed underdose 69.93 9.56 12 130821 75007 90422607
Pulmonary fibrosis 69.63 9.56 34 130799 107469 90390145
Haematochezia 69.51 9.56 243 130590 70670 90426944
Agranulocytosis 68.19 9.56 154 130679 34848 90462766
Malaise 67.75 9.56 1205 129628 584781 89912833
Periorbital oedema 67.71 9.56 65 130768 6734 90490880
Hip arthroplasty 67.19 9.56 14 130819 76194 90421420
Sleep disorder 66.27 9.56 115 130718 197915 90299699
Throat tightness 65.75 9.56 137 130696 29347 90468267
Bursitis 65.70 9.56 56 130777 131598 90366016
Rheumatoid arthritis 65.41 9.56 285 130548 362329 90135285
Red blood cell sedimentation rate increased 65.38 9.56 19 130814 82576 90415038
Loss of personal independence in daily activities 64.20 9.56 61 130772 136044 90361570
Contusion 64.00 9.56 170 130663 251046 90246568
Hypertension 63.22 9.56 394 130439 457138 90040476
Adjustment disorder with depressed mood 62.97 9.56 5 130828 56748 90440866
Night sweats 62.77 9.56 56 130777 128710 90368904
Candida infection 62.11 9.56 146 130687 33911 90463703
Bronchospasm 61.93 9.56 109 130724 20600 90477014
Drug interaction 61.57 9.56 640 130193 275813 90221801
Peripheral swelling 61.15 9.56 348 130485 412758 90084856
International normalised ratio increased 60.84 9.56 178 130655 47138 90450476
Clostridium difficile colitis 60.62 9.56 125 130708 26581 90471033
Allergy to chemicals 59.95 9.56 47 130786 3707 90493907
Diarrhoea 59.94 9.56 1776 129057 937414 89560200
Vascular purpura 59.75 9.56 35 130798 1703 90495911
Autoimmune disorder 58.32 9.56 19 130814 76725 90420889
Condition aggravated 58.31 9.56 564 130269 594981 89902633
Skin candida 57.08 9.56 34 130799 1707 90495907
Blepharospasm 56.01 9.56 7 130826 55438 90442176
Inflammation 55.93 9.56 108 130725 178484 90319130
Chronic kidney disease 55.39 9.56 179 130654 50012 90447602
Fixed eruption 54.68 9.56 33 130800 1697 90495917
Foetal exposure during pregnancy 54.61 9.56 161 130672 42814 90454800
Salpingo-oophorectomy unilateral 54.35 9.56 27 130806 941 90496673
Purpura 53.85 9.56 85 130748 14693 90482921
Colitis 53.14 9.56 221 130612 69721 90427893
Hypoaesthesia 53.05 9.56 253 130580 313957 90183657
Lupus vulgaris 52.83 9.56 3 130830 45056 90452558
Frequent bowel movements 52.29 9.56 191 130642 56744 90440870
Delirium 51.32 9.56 45 130788 104314 90393300
Tooth infection 51.29 9.56 99 130734 20071 90477543
Liver injury 50.97 9.56 106 130727 170461 90327153
Sciatica 50.73 9.56 43 130790 101339 90396275
Chromaturia 49.80 9.56 95 130738 19092 90478522
Osteoarthritis 49.42 9.56 133 130700 195597 90302017
Premature baby 48.47 9.56 110 130723 24967 90472647
Sinusitis fungal 48.39 9.56 32 130801 1932 90495682
Pulmonary pain 47.39 9.56 47 130786 5067 90492547
Tooth demineralisation 47.29 9.56 9 130824 3 90497611
Rectal haemorrhage 46.27 9.56 239 130594 82505 90415109
Epidermal necrosis 45.33 9.56 33 130800 2328 90495286
Hyperleukocytosis 44.71 9.56 23 130810 864 90496750
Dermatitis exfoliative 44.27 9.56 47 130786 5489 90492125
Eczema 44.11 9.56 172 130661 52698 90444916
Drug ineffective for unapproved indication 44.09 9.56 202 130631 66442 90431172
Colitis ulcerative 43.13 9.56 187 130646 60079 90437535
Pharyngeal swelling 43.07 9.56 62 130771 9882 90487732
Sputum increased 42.91 9.56 35 130798 2922 90494692
Dermatitis bullous 42.77 9.56 63 130770 10253 90487361
Therapeutic response decreased 42.56 9.56 40 130793 89689 90407925
Liver function test increased 42.44 9.56 36 130797 84819 90412795
Pseudomembranous colitis 42.39 9.56 39 130794 3829 90493785
Enterocolitis 41.96 9.56 63 130770 10427 90487187
Coagulopathy 41.56 9.56 99 130734 23190 90474424
Confusional state 41.10 9.56 358 130475 385847 90111767
Basilar artery occlusion 40.63 9.56 14 130819 186 90497428
Migraine 40.48 9.56 140 130693 190252 90307362
Documented hypersensitivity to administered product 40.34 9.56 20 130813 694 90496920
Injection site erythema 39.97 9.56 50 130783 98452 90399162
Underdose 39.95 9.56 14 130819 54003 90443611
Crepitations 39.53 9.56 56 130777 8796 90488818
Myelosuppression 39.45 9.56 14 130819 53577 90444037
Oral discomfort 39.17 9.56 61 130772 10422 90487192
Musculoskeletal pain 39.12 9.56 122 130711 171129 90326485
Deep vein thrombosis 38.35 9.56 245 130588 91375 90406239
Tinnitus 38.24 9.56 143 130690 42959 90454655
Hepatic cirrhosis 38.02 9.56 22 130811 63231 90434383
Obstructive airways disorder 37.85 9.56 102 130731 25767 90471847
Incorrect route of product administration 37.65 9.56 13 130820 50613 90447001
Fluid retention 37.57 9.56 43 130790 88048 90409566
Injection site pain 37.42 9.56 127 130706 173572 90324042
Lupus-like syndrome 37.28 9.56 12 130821 48834 90448780
Premature delivery 37.26 9.56 132 130701 38630 90458984
Angiodermatitis 37.11 9.56 13 130820 182 90497432
Somatic delusion 37.09 9.56 18 130815 596 90497018
Pharyngeal oedema 36.75 9.56 69 130764 13702 90483912
Pain in extremity 36.68 9.56 445 130388 450084 90047530
Osteonecrosis of jaw 36.60 9.56 132 130701 38971 90458643
Dental operation 36.35 9.56 25 130808 1611 90496003
Retinitis 36.18 9.56 6 130827 38452 90459162
Tongue discolouration 35.93 9.56 34 130799 3459 90494155
Rash scarlatiniform 35.92 9.56 13 130820 201 90497413
Coeliac disease 35.79 9.56 10 130823 44600 90453014
Therapy non-responder 35.18 9.56 92 130741 136612 90361002
Conjunctivitis 34.84 9.56 101 130732 26605 90471009
Lung disorder 34.07 9.56 107 130726 149776 90347838
Gallbladder disorder 34.07 9.56 83 130750 19720 90477894
Injection site reaction 34.07 9.56 50 130783 92030 90405584
Onychomadesis 33.89 9.56 12 130821 45986 90451628
Renal failure 33.87 9.56 313 130520 130694 90366920
Vomiting 33.57 9.56 1424 129409 786869 89710745
Dyspnoea 33.07 9.56 1571 129262 879384 89618230
Excessive eye blinking 32.95 9.56 22 130811 1350 90496264
Back injury 32.94 9.56 13 130820 46609 90451005
Hepatic ischaemia 32.91 9.56 18 130815 767 90496847
Subretinal haematoma 32.88 9.56 9 130824 51 90497563
Central pain syndrome 32.70 9.56 17 130816 653 90496961
Onychomycosis 32.67 9.56 7 130826 37369 90460245
Malignant neoplasm progression 32.27 9.56 66 130767 106804 90390810
Nail disorder 32.15 9.56 23 130810 59044 90438570
Synovial fluid analysis 32.03 9.56 29 130804 2789 90494825
Peritonsillar abscess 31.43 9.56 16 130817 588 90497026
Crystal nephropathy 31.42 9.56 20 130813 1131 90496483
Device expulsion 31.28 9.56 10 130823 40876 90456738
Exostosis 31.20 9.56 19 130814 53115 90444499
Tongue coated 30.77 9.56 23 130810 1690 90495924
Tenosynovitis stenosans 30.62 9.56 33 130800 3920 90493694
Hepatic failure 30.54 9.56 126 130707 39602 90458012
Lymphadenopathy 30.46 9.56 139 130694 45636 90451978
Arthritis 30.44 9.56 131 130702 167184 90330430
Localised oedema 30.38 9.56 41 130792 6153 90491461
Drug intolerance 30.32 9.56 459 130374 447132 90050482
Deafness 30.20 9.56 86 130747 22428 90475186
Anhedonia 30.16 9.56 57 130776 11374 90486240
Renal tubular necrosis 29.42 9.56 65 130768 14490 90483124
Embolism venous 29.42 9.56 31 130802 3589 90494025
Liver disorder 29.41 9.56 84 130749 121185 90376429
Allergy to animal 29.24 9.56 22 130811 1632 90495982
Pyrexia 29.20 9.56 1198 129635 659287 89838327
Neutropenic sepsis 29.09 9.56 74 130759 18056 90479558
Eye swelling 29.05 9.56 101 130732 29285 90468329
Foot deformity 28.99 9.56 26 130807 59625 90437989
Wound complication 28.84 9.56 35 130798 4728 90492886
Dysphagia 28.39 9.56 267 130566 112011 90385603
Constipation 28.29 9.56 565 130268 279830 90217784
Moraxella test positive 28.19 9.56 7 130826 25 90497589
Breast cancer 27.89 9.56 22 130811 53739 90443875
Joint dislocation 27.52 9.56 15 130818 44567 90453047
Sebaceous gland infection 27.32 9.56 10 130823 160 90497454
Adverse reaction 27.15 9.56 5 130828 29707 90467907
Muscle relaxant therapy 27.15 9.56 10 130823 163 90497451
Bone erosion 27.12 9.56 22 130811 52999 90444615
Respiratory symptom 26.98 9.56 32 130801 4220 90493394
Myalgia 26.92 9.56 378 130455 174747 90322867
Infection 26.73 9.56 365 130468 361729 90135885
Memory impairment 26.60 9.56 171 130662 197073 90300541
Gamma-glutamyltransferase increased 26.57 9.56 117 130716 37835 90459779
Hypoaesthesia oral 26.43 9.56 65 130768 15535 90482079
Quality of life decreased 26.22 9.56 55 130778 11834 90485780
Normal tension glaucoma 26.14 9.56 7 130826 36 90497578
Tubulointerstitial nephritis and uveitis syndrome 26.05 9.56 11 130822 261 90497353
Mouth ulceration 25.58 9.56 120 130713 39854 90457760
Mouth swelling 25.55 9.56 36 130797 5626 90491988
Knee arthroplasty 25.43 9.56 51 130782 83131 90414483
Influenza B virus test positive 25.30 9.56 11 130822 281 90497333
Henoch-Schonlein purpura 25.19 9.56 20 130813 1607 90496007
Toothache 25.18 9.56 80 130753 22150 90475464
Mania 25.16 9.56 60 130773 14064 90483550
Lip and/or oral cavity cancer 25.12 9.56 16 130817 906 90496708
Hepatorenal syndrome 25.11 9.56 22 130811 2026 90495588
Tenosynovitis 25.00 9.56 61 130772 14506 90483108
Walking aid user 24.92 9.56 10 130823 35496 90462118
Scleritis 24.83 9.56 34 130799 5174 90492440
Hepatic necrosis 24.81 9.56 38 130795 6400 90491214
Pharyngitis streptococcal 24.74 9.56 56 130777 12686 90484928
Haematuria 24.68 9.56 108 130725 34829 90462785
Cheilitis 24.34 9.56 33 130800 4974 90492640
Staphylococcal scalded skin syndrome 24.31 9.56 9 130824 149 90497465
Biliary dyskinesia 24.29 9.56 24 130809 2575 90495039
Amnesia 24.28 9.56 78 130755 108427 90389187
Biliary sepsis 24.14 9.56 16 130817 970 90496644
Odynophagia 23.75 9.56 45 130788 8998 90488616
Road traffic accident 23.64 9.56 78 130755 107548 90390066
Rash pustular 23.59 9.56 42 130791 8007 90489607
Tooth disorder 23.42 9.56 98 130735 30992 90466622
Campylobacter infection 23.41 9.56 17 130816 1195 90496419
Product quality issue 23.10 9.56 50 130783 79275 90418339
Febrile neutropenia 23.06 9.56 134 130699 158215 90339399
Hepatic perfusion disorder 22.87 9.56 7 130826 62 90497552
Ulcer haemorrhage 22.86 9.56 5 130828 26316 90471298
Renal colic 22.81 9.56 19 130814 1634 90495980
Incision site haemorrhage 22.72 9.56 13 130820 605 90497009
Hepatitis acute 22.44 9.56 49 130784 10838 90486776
Accidental exposure to product 22.40 9.56 17 130816 42349 90455265
Pancreatic failure 22.37 9.56 18 130815 1474 90496140
Epilepsy 22.17 9.56 54 130779 82152 90415462
Skin reaction 22.15 9.56 68 130765 18485 90479129
Haemoglobin decreased 21.92 9.56 342 130491 161614 90336000
Foetal non-stress test abnormal 21.92 9.56 6 130827 34 90497580
Atelectasis 21.67 9.56 81 130752 24328 90473286
Injection site swelling 21.64 9.56 33 130800 59806 90437808
Allergic hepatitis 21.63 9.56 6 130827 36 90497578
Prothrombin time ratio decreased 21.63 9.56 15 130818 980 90496634
Circulatory collapse 21.57 9.56 82 130751 24822 90472792
Pharyngeal abscess 21.49 9.56 11 130822 409 90497205
Adverse drug reaction 21.45 9.56 91 130742 116610 90381004
Laryngitis 21.40 9.56 25 130808 50728 90446886
Live birth 21.31 9.56 52 130781 79055 90418559
Decreased appetite 21.28 9.56 399 130434 376141 90121473
Nephritis allergic 20.92 9.56 10 130823 320 90497294
Burning sensation 20.86 9.56 160 130673 63292 90434322
Synovial disorder 20.67 9.56 24 130809 3094 90494520
Serum sickness-like reaction 20.64 9.56 12 130821 576 90497038
Tricuspid valve incompetence 20.61 9.56 62 130771 16669 90480945
Labile blood pressure 20.43 9.56 19 130814 1891 90495723
Finger deformity 20.41 9.56 11 130822 32886 90464728
Pleuritic pain 20.34 9.56 46 130787 10415 90487199
Taste disorder 20.34 9.56 36 130797 61510 90436104
Pregnancy on oral contraceptive 20.09 9.56 15 130818 1100 90496514
Musculoskeletal stiffness 20.09 9.56 304 130529 296228 90201386
Fibrous histiocytoma 20.05 9.56 12 130821 608 90497006
Nail dystrophy 19.97 9.56 16 130817 1302 90496312
Emphysema 19.91 9.56 50 130783 12105 90485509
Hypersensitivity 19.89 9.56 824 130009 453853 90043761
Lip ulceration 19.89 9.56 20 130813 2192 90495422
Deformity 19.87 9.56 50 130783 12120 90485494
Chest discomfort 19.81 9.56 295 130538 138070 90359544
Immunodeficiency 19.66 9.56 20 130813 43214 90454400
Pharyngotonsillitis 19.59 9.56 8 130825 174 90497440
Symmetrical drug-related intertriginous and flexural exanthema 19.52 9.56 14 130819 965 90496649
Eosinophils urine present 19.50 9.56 5 130828 21 90497593
Hallucination, auditory 19.49 9.56 59 130774 15916 90481698
Cell death 19.40 9.56 23 130810 3032 90494582
Tooth discolouration 19.13 9.56 15 130818 1183 90496431
Respiratory disorder neonatal 19.12 9.56 16 130817 1385 90496229
Tremor 19.06 9.56 319 130514 152854 90344760
Tuberculin test positive 18.80 9.56 25 130808 3700 90493914
Lip erosion 18.70 9.56 15 130818 1223 90496391
Diastolic dysfunction 18.65 9.56 36 130797 7297 90490317
Hyperaemia 18.64 9.56 21 130812 2621 90494993
Bone marrow eosinophilic leukocyte count increased 18.47 9.56 5 130828 27 90497587
C-reactive protein increased 18.45 9.56 170 130663 181219 90316395
Eye pain 18.41 9.56 118 130715 44050 90453564
Photophobia 18.40 9.56 70 130763 21199 90476415
Jarisch-Herxheimer reaction 18.29 9.56 10 130823 426 90497188
Oropharyngeal pain 18.25 9.56 250 130583 114937 90382677
Foetal heart rate decreased 18.20 9.56 8 130825 210 90497404
Sweat discolouration 18.13 9.56 4 130829 7 90497607
Asthenia 18.12 9.56 610 130223 533141 89964473
Laryngeal discomfort 18.01 9.56 10 130823 439 90497175
Lower respiratory tract infection 18.01 9.56 254 130579 250405 90247209
Haemolytic anaemia 18.00 9.56 47 130786 11650 90485964
Diverticulum 17.96 9.56 48 130785 12065 90485549
Eosinophilic pneumonia 17.81 9.56 21 130812 2752 90494862
Low birth weight baby 17.71 9.56 41 130792 9426 90488188
Vertebrobasilar insufficiency 17.69 9.56 8 130825 225 90497389
Otitis media 17.68 9.56 31 130802 5839 90491775
Muscle spasticity 17.64 9.56 15 130818 35307 90462307
Caesarean section 17.63 9.56 63 130770 18514 90479100
Oral mucosal hypertrophy 17.62 9.56 5 130828 33 90497581
Pneumonia aspiration 17.44 9.56 20 130813 40920 90456694
Selective eating disorder 17.44 9.56 18 130815 2035 90495579
Budd-Chiari syndrome 17.39 9.56 6 130827 80 90497534
Norovirus test positive 17.37 9.56 8 130825 235 90497379
Behaviour disorder 17.36 9.56 27 130806 4608 90493006
Oropharyngeal discomfort 17.31 9.56 36 130797 7699 90489915
Abnormal faeces 17.24 9.56 33 130800 6649 90490965
Bipolar I disorder 17.22 9.56 18 130815 2064 90495550
Conjunctival hyperaemia 17.13 9.56 22 130811 3147 90494467
Diastasis recti abdominis 17.12 9.56 5 130828 37 90497577
Reaction to excipient 17.06 9.56 17 130816 1843 90495771
Atrophy 17.01 9.56 18 130815 2094 90495520
Sedation 17.00 9.56 27 130806 48144 90449470
Atrial septal defect 16.90 9.56 37 130796 8197 90489417
Choluria 16.88 9.56 8 130825 251 90497363
Muscular weakness 16.83 9.56 204 130629 206462 90291152
Dry mouth 16.83 9.56 177 130656 183882 90313732
Macule 16.79 9.56 20 130813 2649 90494965
Hallucination, visual 16.78 9.56 72 130761 23020 90474594
Facial paralysis 16.77 9.56 55 130778 15479 90482135
Pneumonia mycoplasmal 16.76 9.56 13 130820 1009 90496605
Serum sickness 16.70 9.56 23 130810 3519 90494095
Osteoporosis 16.69 9.56 77 130756 96454 90401160
Congenital melanocytic naevus 16.64 9.56 4 130829 12 90497602
Infantile colic 16.63 9.56 3 130830 0 90497614
Fungal infection 16.58 9.56 112 130721 42549 90455065
Injection site alopecia 16.57 9.56 5 130828 42 90497572
Injection site pruritus 16.46 9.56 33 130800 53801 90443813
Ocular hyperaemia 16.44 9.56 94 130739 33704 90463910
Skin exfoliation 16.42 9.56 160 130673 67753 90429861
Femoral artery embolism 16.36 9.56 5 130828 44 90497570
Neutrophil toxic granulation present 16.35 9.56 7 130826 172 90497442
Device malfunction 16.28 9.56 5 130828 20972 90476642
Antinuclear antibody positive 16.18 9.56 39 130794 9202 90488412
Hiatus hernia 16.13 9.56 76 130757 25285 90472329
Muscle spasms 16.12 9.56 261 130572 251622 90245992
Dysentery 16.11 9.56 13 130820 1069 90496545
Urinary tract obstruction 16.08 9.56 18 130815 2231 90495383
Eosinophilic pneumonia acute 16.06 9.56 11 130822 704 90496910
Psychotic symptom 16.03 9.56 18 130815 2238 90495376
Cholelithiasis 15.94 9.56 130 130703 52376 90445238
Neonatal respiratory distress syndrome 15.94 9.56 21 130812 3080 90494534
Fear-related avoidance of activities 15.92 9.56 7 130826 184 90497430
Injection site warmth 15.89 9.56 3 130830 17512 90480102
Infectious mononucleosis 15.88 9.56 17 130816 2004 90495610
Gastritis 15.86 9.56 109 130724 41644 90455970
Tryptase increased 15.85 9.56 10 130823 557 90497057
Anaemia 15.79 9.56 641 130192 352161 90145453
PRIDE syndrome 15.75 9.56 4 130829 16 90497598
Polymenorrhagia 15.70 9.56 5 130828 51 90497563
Biliary colic 15.68 9.56 24 130809 4039 90493575
Visual snow syndrome 15.62 9.56 5 130828 52 90497562
Actinomycosis 15.55 9.56 13 130820 1123 90496491
Cholecystitis 15.50 9.56 57 130776 16983 90480631
Neutrophilia 15.48 9.56 29 130804 5749 90491865
Swelling of eyelid 15.40 9.56 28 130805 5426 90492188
Anaphylactoid reaction 15.32 9.56 25 130808 4443 90493171
Hepatic enzyme decreased 15.31 9.56 12 130821 946 90496668
Transaminases increased 15.27 9.56 99 130734 37093 90460521
Maternal drugs affecting foetus 15.24 9.56 27 130806 5128 90492486
Pharyngeal erythema 15.23 9.56 16 130817 1846 90495768
Acute febrile neutrophilic dermatosis 15.20 9.56 22 130811 3523 90494091
Meconium in amniotic fluid 15.18 9.56 8 130825 316 90497298
Sedation complication 15.17 9.56 3 130830 16941 90480673
Off label use 15.15 9.56 1378 129455 1100874 89396740
Lip pain 15.15 9.56 17 130816 2113 90495501
Cerebellar syndrome 15.13 9.56 23 130810 3849 90493765
Multiple lentigines syndrome 15.12 9.56 7 130826 208 90497406
Target skin lesion 15.07 9.56 6 130827 122 90497492
XIth nerve injury 15.05 9.56 5 130828 59 90497555
Pulmonary artery stenosis congenital 15.03 9.56 9 130824 456 90497158
Ear swelling 14.98 9.56 16 130817 1881 90495733
Lymphocytosis 14.95 9.56 20 130813 2977 90494637
Foetal hypokinesia 14.93 9.56 10 130823 617 90496997
Tracheal pain 14.90 9.56 5 130828 61 90497553
Exposure keratitis 14.75 9.56 5 130828 63 90497551
Staphylococcal infection 14.74 9.56 120 130713 48319 90449295
Blood alkaline phosphatase increased 14.57 9.56 119 130714 47960 90449654
Foetal distress syndrome 14.57 9.56 15 130818 1690 90495924
Posterior reversible encephalopathy syndrome 14.56 9.56 7 130826 22332 90475282
Varicose veins pelvic 14.55 9.56 3 130830 3 90497611
Mucosal inflammation 14.55 9.56 137 130696 57488 90440126
Pseudomyopia 14.54 9.56 5 130828 66 90497548
Vasoplegia syndrome 14.37 9.56 19 130814 2795 90494819
Psoriasis 14.37 9.56 140 130693 147614 90350000
Red blood cell sedimentation rate decreased 14.36 9.56 12 130821 1036 90496578
Idiopathic urticaria 14.29 9.56 8 130825 357 90497257
Caffeine allergy 14.28 9.56 4 130829 25 90497589
Claudication of jaw muscles 14.27 9.56 5 130828 70 90497544
Diabetes mellitus 14.26 9.56 47 130786 64828 90432786
Papule 14.26 9.56 34 130799 7968 90489646
Therapy partial responder 14.22 9.56 7 130826 22036 90475578
Productive cough 14.21 9.56 172 130661 76891 90420723
Meningioma surgery 14.21 9.56 5 130828 71 90497543
Blood glucose increased 14.18 9.56 80 130753 95166 90402448
Injection site haemorrhage 14.18 9.56 12 130821 28306 90469308
HCoV-OC43 infection 14.15 9.56 4 130829 26 90497588
Macroglossia 14.03 9.56 11 130822 868 90496746
Rhabdomyolysis 14.02 9.56 124 130709 51132 90446482
Foetal exposure during delivery 13.99 9.56 8 130825 372 90497242
Synovial cyst 13.96 9.56 43 130790 11709 90485905
Status epilepticus 13.83 9.56 59 130774 18815 90478799
Respiratory distress 13.82 9.56 100 130733 38846 90458768
Exposed bone in jaw 13.79 9.56 19 130814 2907 90494707
Gingivitis 13.76 9.56 37 130796 9332 90488282
Osteolysis 13.75 9.56 21 130812 3529 90494085
Tongue eruption 13.70 9.56 6 130827 156 90497458
Blood pressure fluctuation 13.69 9.56 35 130798 52378 90445236
Pulmonary embolism 13.65 9.56 265 130568 130555 90367059
Delusion of grandeur 13.61 9.56 7 130826 263 90497351
Ureteric obstruction 13.54 9.56 16 130817 2102 90495512
Mucosal pain 13.54 9.56 4 130829 31 90497583
Klebsiella infection 13.49 9.56 39 130794 10258 90487356
Cognitive disorder 13.45 9.56 53 130780 69354 90428260
Labelled drug-drug interaction medication error 13.45 9.56 49 130784 14533 90483081
Autoimmune hepatitis 13.36 9.56 39 130794 10312 90487302
Parotid gland enlargement 13.35 9.56 11 130822 932 90496682
Hepatomegaly 13.34 9.56 46 130787 13280 90484334
Newcastle disease 13.34 9.56 3 130830 6 90497608
Brain stem auditory evoked response abnormal 13.34 9.56 3 130830 6 90497608
Oral fungal infection 13.31 9.56 20 130813 3312 90494302
Eyelid haematoma 13.27 9.56 5 130828 87 90497527
Cushingoid 13.26 9.56 39 130794 10356 90487258
Maternal exposure timing unspecified 13.26 9.56 8 130825 22475 90475139
Osteomyelitis 13.25 9.56 77 130756 27769 90469845
Erythema nodosum 13.23 9.56 27 130806 5697 90491917
Graft infection 13.23 9.56 7 130826 279 90497335
Bone disorder 13.07 9.56 67 130766 23053 90474561
Fear 13.00 9.56 53 130780 16569 90481045
Talipes 12.97 9.56 14 130819 1666 90495948
Carcinoid crisis 12.96 9.56 7 130826 291 90497323
Delayed delivery 12.91 9.56 4 130829 37 90497577
Gallbladder cholesterolosis 12.88 9.56 10 130823 778 90496836
Haemolytic uraemic syndrome 12.87 9.56 18 130815 2793 90494821
Pallor 12.86 9.56 89 130744 34076 90463538
Multiple sclerosis relapse 12.85 9.56 36 130797 52269 90445345
Oliguria 12.74 9.56 39 130794 10585 90487029
Drug tolerance 12.65 9.56 5 130828 17911 90479703
Life expectancy shortened 12.63 9.56 4 130829 40 90497574
Pharyngeal paraesthesia 12.61 9.56 19 130814 3155 90494459
Ovarian cyst 12.59 9.56 54 130779 17264 90480350
Tooth abscess 12.57 9.56 52 130781 16361 90481253
Glomerulonephritis acute 12.54 9.56 5 130828 102 90497512
Palatal polyp 12.48 9.56 3 130830 9 90497605
Food interaction 12.43 9.56 12 130821 1252 90496362
Allergy to arthropod bite 12.42 9.56 8 130825 462 90497152
Exposure via breast milk 12.40 9.56 16 130817 2299 90495315
Mucosal discolouration 12.35 9.56 9 130824 636 90496978
Pain 12.35 9.56 1255 129578 995086 89502528
Clostridium colitis 12.34 9.56 15 130818 2030 90495584
Nightmare 12.31 9.56 63 130770 21662 90475952
Infantile apnoea 12.24 9.56 12 130821 1275 90496339
Renal disorder 12.18 9.56 95 130738 37764 90459850
Petechiae 12.16 9.56 50 130783 15691 90481923
Vestibular disorder 12.12 9.56 13 130820 1536 90496078
Monoclonal gammopathy 11.95 9.56 10 130823 865 90496749
Cholestasis of pregnancy 11.93 9.56 13 130820 1564 90496050
Liver function test abnormal 11.91 9.56 119 130714 50726 90446888
Product administration error 11.89 9.56 72 130761 26351 90471263
No adverse event 11.89 9.56 54 130779 67928 90429686
Hand-foot-and-mouth disease 11.84 9.56 8 130825 501 90497113
Septic shock 11.83 9.56 72 130761 84088 90413526
Enanthema 11.82 9.56 8 130825 502 90497112
Lymphocyte morphology abnormal 11.81 9.56 8 130825 503 90497111
Bone density decreased 11.78 9.56 53 130780 17292 90480322
Maternal exposure during pregnancy 11.77 9.56 634 130199 359429 90138185
Hydronephrosis 11.72 9.56 42 130791 12360 90485254
Spondylitis 11.71 9.56 3 130830 14175 90483439
Hepatitis toxic 11.65 9.56 20 130813 3705 90493909
Blood test abnormal 11.61 9.56 8 130825 20944 90476670
Respiratory failure 11.60 9.56 112 130721 118306 90379308
Disability 11.60 9.56 26 130807 40719 90456895
Sleep disorder due to a general medical condition 11.59 9.56 30 130803 44708 90452906
Subacute hepatic failure 11.53 9.56 5 130828 127 90497487
Idiopathic angioedema 11.42 9.56 4 130829 56 90497558
Neoplasm progression 11.39 9.56 30 130803 44456 90453158
Tongue blistering 11.39 9.56 14 130819 1916 90495698
Palpitations 11.37 9.56 268 130565 136460 90361154
Injection site urticaria 11.20 9.56 6 130827 18005 90479609
Injection site rash 11.20 9.56 11 130822 24162 90473452
Hypotonia neonatal 11.19 9.56 12 130821 1418 90496196
Kounis syndrome 11.18 9.56 16 130817 2537 90495077
Gingival pain 11.17 9.56 35 130798 9617 90487997
Viral rash 11.14 9.56 7 130826 387 90497227
Chest pain 11.14 9.56 364 130469 319281 90178333
Pancreatitis acute 11.13 9.56 82 130751 32033 90465581
Uterine contractions abnormal 11.09 9.56 6 130827 250 90497364
Right ventricular failure 11.09 9.56 7 130826 19198 90478416
Genital prolapse 11.04 9.56 4 130829 62 90497552
Bone sequestrum 11.03 9.56 12 130821 1441 90496173
Hospitalisation 10.99 9.56 125 130708 127975 90369639
Congenital tricuspid valve incompetence 10.98 9.56 5 130828 143 90497471
Analgesic drug level increased 10.93 9.56 17 130816 2902 90494712
Loefgren syndrome 10.91 9.56 5 130828 145 90497469
Infusion site reaction 10.91 9.56 7 130826 19032 90478582
Dysgeusia 10.89 9.56 120 130713 52440 90445174
Tooth extraction 10.89 9.56 39 130794 11474 90486140
Forced vital capacity abnormal 10.87 9.56 4 130829 65 90497549
Vertigo 10.85 9.56 151 130682 69660 90427954
Tangentiality 10.82 9.56 4 130829 66 90497548
Spinal subdural haematoma 10.79 9.56 5 130828 149 90497465
Palatal swelling 10.73 9.56 5 130828 151 90497463
Tonsillitis 10.72 9.56 28 130805 6941 90490673
Tongue pruritus 10.70 9.56 9 130824 784 90496830
Diabetic retinal oedema 10.70 9.56 7 130826 415 90497199
Skin swelling 10.62 9.56 27 130806 6587 90491027
Alexithymia 10.60 9.56 4 130829 70 90497544
Cerebral venous sinus thrombosis 10.56 9.56 15 130818 2361 90495253
Hepatosplenomegaly 10.54 9.56 17 130816 2992 90494622
Premenstrual syndrome 10.54 9.56 9 130824 801 90496813
Muscle haemorrhage 10.51 9.56 18 130815 3328 90494286
Abdominal wall haematoma 10.49 9.56 18 130815 3334 90494280
Feeling jittery 10.47 9.56 47 130786 15324 90482290
Tympanic membrane perforation 10.46 9.56 15 130818 2382 90495232
Haemodynamic instability 10.46 9.56 39 130794 11700 90485914
Transverse sinus thrombosis 10.45 9.56 8 130825 609 90497005
Metastases to lung 10.44 9.56 5 130828 15986 90481628
Scar 10.43 9.56 47 130786 15348 90482266
Sebaceous gland disorder 10.42 9.56 3 130830 21 90497593
Nasal polyps 10.41 9.56 37 130796 10843 90486771
Hypovolaemic shock 10.41 9.56 28 130805 7066 90490548
Haemangioma 10.40 9.56 17 130816 3025 90494589
Rhinitis 10.40 9.56 43 130790 13529 90484085
Anti-glomerular basement membrane disease 10.39 9.56 4 130829 74 90497540
Poor sucking reflex 10.36 9.56 7 130826 438 90497176
Mental disorder 10.35 9.56 81 130752 32237 90465377
Adrenal insufficiency 10.35 9.56 17 130816 29904 90467710
Acute psychosis 10.25 9.56 17 130816 3061 90494553
Hypotonia 10.21 9.56 38 130795 11388 90486226
Lymphadenitis 10.15 9.56 20 130813 4117 90493497
Genital erosion 10.11 9.56 7 130826 456 90497158
Tendonitis 10.11 9.56 59 130774 21313 90476301
Eyelid injury 10.07 9.56 5 130828 174 90497440
Non-alcoholic steatohepatitis 10.07 9.56 13 130820 1869 90495745
Suspected product contamination 10.06 9.56 4 130829 81 90497533
Immune thrombocytopenia 10.03 9.56 42 130791 13284 90484330
Pulmonary toxicity 10.01 9.56 38 130795 11493 90486121
Pharyngitis 10 9.56 60 130773 21887 90475727
Hypoventilation 9.98 9.56 23 130810 5273 90492341
Transplant rejection 9.98 9.56 3 130830 12755 90484859
Periodontitis 9.90 9.56 19 130814 3834 90493780
Retinal neovascularisation 9.88 9.56 4 130829 85 90497529
Dysstasia 9.87 9.56 13 130820 25039 90472575
Vasoconstriction 9.85 9.56 9 130824 876 90496738
Lip discolouration 9.82 9.56 8 130825 667 90496947
Parkinsonism 9.81 9.56 4 130829 14061 90483553
Hepatitis 9.80 9.56 150 130683 70589 90427025
Disease progression 9.78 9.56 163 130670 156452 90341162
Drug-induced liver injury 9.77 9.56 184 130649 90134 90407480
Hyperthermia 9.76 9.56 35 130798 10300 90487314
Pelvic congestion 9.76 9.56 3 130830 27 90497587
Vibratory sense increased 9.76 9.56 3 130830 27 90497587
Strawberry tongue 9.76 9.56 3 130830 27 90497587
Mycoplasma infection 9.74 9.56 9 130824 889 90496725
Eosinophilic myocarditis 9.71 9.56 8 130825 677 90496937
Pneumopericardium 9.71 9.56 4 130829 89 90497525
Eye oedema 9.70 9.56 13 130820 1939 90495675
Eosinophil count increased 9.67 9.56 41 130792 13040 90484574
Nail infection 9.66 9.56 15 130818 2557 90495057
Depressed mood 9.66 9.56 113 130720 50109 90447505
Laryngeal obstruction 9.63 9.56 4 130829 91 90497523
Paranasal sinus discomfort 9.61 9.56 25 130808 6185 90491429
Choking sensation 9.60 9.56 19 130814 3923 90493691
Phlebitis 9.59 9.56 28 130805 7402 90490212
Coordination abnormal 9.57 9.56 10 130823 21346 90476268
Abdominal rebound tenderness 9.57 9.56 3 130830 29 90497585

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 658.77 10.33 581 79457 41494 42499803
Anaphylactic shock 580.10 10.33 424 79614 23093 42518204
Urticaria 518.12 10.33 666 79372 73370 42467927
Pruritus 396.28 10.33 1002 79036 187769 42353528
Rash maculo-papular 386.94 10.33 412 79626 37091 42504206
Anaphylactic reaction 372.76 10.33 430 79608 42313 42498984
Acute generalised exanthematous pustulosis 284.98 10.33 186 79852 8409 42532888
Angioedema 281.10 10.33 372 79666 42105 42499192
Rash 279.55 10.33 1143 78895 275811 42265486
Lip oedema 258.03 10.33 124 79914 3060 42538237
Crystalluria 248.66 10.33 81 79957 669 42540628
Meningitis aseptic 237.10 10.33 131 79907 4351 42536946
Cholestasis 236.34 10.33 300 79738 32579 42508718
Face oedema 234.45 10.33 199 79839 13467 42527830
Type I hypersensitivity 233.99 10.33 103 79935 2063 42539234
Death 228.33 10.33 333 79705 470852 42070445
Erythema 214.85 10.33 565 79473 108228 42433069
Eosinophilia 202.19 10.33 278 79760 32621 42508676
Drug hypersensitivity 201.18 10.33 521 79517 98868 42442429
Hepatocellular injury 182.86 10.33 224 79814 23454 42517843
Acute kidney injury 171.27 10.33 1227 78811 366110 42175187
Allergy test positive 157.69 10.33 41 79997 132 42541165
Lip swelling 151.59 10.33 183 79855 18870 42522427
Hypersensitivity 148.04 10.33 381 79657 71989 42469308
Cross sensitivity reaction 144.17 10.33 68 79970 1607 42539690
Hepatic cytolysis 134.55 10.33 206 79832 26638 42514659
Stevens-Johnson syndrome 132.63 10.33 185 79853 21993 42519304
Toxic epidermal necrolysis 132.28 10.33 204 79834 26546 42514751
Drug ineffective 128.82 10.33 679 79359 629518 41911779
Off label use 121.04 10.33 705 79333 637630 41903667
Kounis syndrome 114.36 10.33 74 79964 3294 42538003
Toxic skin eruption 111.06 10.33 133 79905 13597 42527700
Eyelid oedema 99.86 10.33 84 79954 5611 42535686
Osteotomy 98.83 10.33 24 80014 53 42541244
Wound closure 97.33 10.33 24 80014 58 42541239
Drug abuse 96.42 10.33 38 80000 104733 42436564
Serum sickness-like reaction 95.20 10.33 30 80008 220 42541077
Rash erythematous 93.19 10.33 194 79844 31897 42509400
Disease progression 90.34 10.33 82 79956 143574 42397723
Fixed eruption 88.48 10.33 56 79982 2398 42538899
Rash morbilliform 87.08 10.33 68 79970 4085 42537212
Malignant neoplasm progression 84.93 10.33 49 79989 108351 42432946
Tongue oedema 84.55 10.33 61 79977 3249 42538048
Completed suicide 80.86 10.33 40 79998 96425 42444872
Jaundice 80.06 10.33 191 79847 34398 42506899
Neuropsychiatric lupus 77.25 10.33 20 80018 63 42541234
Hepatitis cholestatic 75.92 10.33 93 79945 9731 42531566
Swelling face 75.86 10.33 163 79875 27391 42513906
Symmetrical drug-related intertriginous and flexural exanthema 73.97 10.33 35 80003 833 42540464
Toxicity to various agents 72.13 10.33 207 79831 228929 42312368
Tooth disorder 68.75 10.33 98 79940 11881 42529416
Acute psychosis 67.56 10.33 45 79993 2104 42539193
Tubulointerstitial nephritis 66.43 10.33 168 79870 31380 42509917
Crystal nephropathy 64.14 10.33 29 80009 620 42540677
Rash pruritic 62.65 10.33 171 79867 33432 42507865
Drug-induced liver injury 61.86 10.33 185 79853 38088 42503209
Enterocolitis haemorrhagic 60.77 10.33 33 80005 1058 42540239
Wheezing 60.47 10.33 233 79805 54548 42486749
Drug eruption 59.54 10.33 133 79905 22942 42518355
Vesicoureteric reflux 59.02 10.33 20 80018 189 42541108
Skin test positive 56.60 10.33 24 80014 437 42540860
Erythema multiforme 56.35 10.33 81 79957 9896 42531401
Purpura 55.11 10.33 88 79950 11791 42529506
Urethral atresia 54.40 10.33 13 80025 26 42541271
Swollen tongue 54.36 10.33 122 79916 21109 42520188
Premature baby 53.73 10.33 128 79910 23025 42518272
Dyspnoea 53.23 10.33 1144 78894 441477 42099820
Vascular purpura 52.92 10.33 39 79999 2147 42539150
Dermatitis exfoliative generalised 51.39 10.33 59 79979 5765 42535532
Type IV hypersensitivity reaction 51.30 10.33 40 79998 2397 42538900
Fall 47.94 10.33 252 79786 234268 42307029
Helicobacter test positive 46.11 10.33 25 80013 799 42540498
Foetal megacystis 45.80 10.33 13 80025 63 42541234
Blindness cortical 45.44 10.33 21 80017 473 42540824
Skin exfoliation 45.25 10.33 176 79862 41377 42499920
Spirometry abnormal 45.18 10.33 52 79986 5094 42536203
Acute hepatic failure 44.71 10.33 99 79939 16974 42524323
Clostridium difficile colitis 43.51 10.33 112 79926 21140 42520157
Jaundice cholestatic 42.66 10.33 51 79987 5202 42536095
Bradycardia 42.54 10.33 59 79979 85425 42455872
Foetal disorder 42.38 10.33 26 80012 1053 42540244
Degenerative mitral valve disease 41.87 10.33 17 80021 276 42541021
Neutropenia neonatal 40.88 10.33 24 80014 896 42540401
Mixed liver injury 40.62 10.33 46 79992 4428 42536869
Liver injury 40.33 10.33 102 79936 19046 42522251
Tooth demineralisation 39.69 10.33 8 80030 3 42541294
Hepatitis acute 39.61 10.33 65 79973 8910 42532387
Mite allergy 39.36 10.33 48 79990 4998 42536299
Foetal exposure during pregnancy 38.86 10.33 184 79854 47127 42494170
Rash macular 38.78 10.33 93 79945 16798 42524499
Cholestatic liver injury 38.65 10.33 41 79997 3668 42537629
Fatigue 38.61 10.33 581 79457 435060 42106237
Therapeutic product effect decreased 38.02 10.33 13 80025 39137 42502160
Hepatitis 37.71 10.33 125 79913 27175 42514122
Injection site pain 37.49 10.33 32 80006 57766 42483531
Pulmonary vasculitis 37.05 10.33 52 79986 6214 42535083
Dermatitis bullous 36.99 10.33 61 79977 8395 42532902
Sputum increased 36.63 10.33 37 80001 3126 42538171
Conjunctivitis allergic 36.36 10.33 50 79988 5861 42535436
Myelosuppression 35.08 10.33 16 80022 40445 42500852
Drug intolerance 34.78 10.33 61 79977 80363 42460934
Documented hypersensitivity to administered product 33.77 10.33 15 80023 307 42540990
Intentional product misuse 33.61 10.33 40 79998 61860 42479437
Conjunctival irritation 33.54 10.33 11 80027 93 42541204
Rash vesicular 33.43 10.33 36 80002 3277 42538020
Bronchospasm 32.93 10.33 74 79964 12811 42528486
Otospondylomegaepiphyseal dysplasia 32.36 10.33 11 80027 105 42541192
Platelet count decreased 32.31 10.33 142 79896 138439 42402858
Cardiac failure congestive 31.78 10.33 71 79967 85531 42455766
Malaise 31.67 10.33 567 79471 211589 42329708
Product use in unapproved indication 31.41 10.33 210 79828 184246 42357051
Mycotic allergy 31.04 10.33 42 79996 4849 42536448
Factitious disorder 30.99 10.33 9 80029 48 42541249
White blood cell count decreased 30.95 10.33 105 79933 110291 42431006
Skin reaction 30.94 10.33 51 79987 7016 42534281
Myocardial infarction 30.80 10.33 124 79914 123885 42417412
Frontal lobe epilepsy 30.71 10.33 8 80030 26 42541271
Pulmonary vascular disorder 30.71 10.33 18 80020 670 42540627
Stress 30.52 10.33 23 80015 44189 42497108
Neuritis 30.12 10.33 47 79991 6173 42535124
Low birth weight baby 29.85 10.33 61 79977 9894 42531403
Gingivitis 29.71 10.33 37 80001 3936 42537361
Rheumatoid arthritis 29.40 10.33 22 80016 42418 42498879
Rash papular 29.26 10.33 67 79971 11744 42529553
Helicobacter infection 29.05 10.33 30 80008 2602 42538695
Laryngeal dyspnoea 28.66 10.33 10 80028 104 42541193
Prostate cancer 28.61 10.33 25 80013 44618 42496679
Dust allergy 28.24 10.33 42 79996 5290 42536007
Nicotine dependence 27.99 10.33 17 80021 676 42540621
Ureteric compression 27.92 10.33 13 80025 298 42540999
Inappropriate schedule of product administration 27.71 10.33 90 79948 95812 42445485
Infective exacerbation of chronic obstructive airways disease 27.70 10.33 26 80012 2007 42539290
Lichen spinulosus 27.53 10.33 6 80032 6 42541291
Oral mucosal eruption 27.48 10.33 14 80024 393 42540904
Mouth swelling 27.35 10.33 27 80011 2219 42539078
Agranulocytosis 27.32 10.33 122 79916 30490 42510807
Macroglossia 27.17 10.33 15 80023 497 42540800
Urethral valves 26.87 10.33 12 80026 249 42541048
Cerebrovascular accident 26.83 10.33 93 79945 97067 42444230
Weight increased 26.80 10.33 108 79930 107875 42433422
Dermatitis allergic 26.65 10.33 53 79985 8430 42532867
Product dose omission issue 26.64 10.33 175 79863 154190 42387107
Eye injury 26.61 10.33 19 80019 995 42540302
Cardiac failure 26.44 10.33 107 79931 106749 42434548
Infusion related reaction 26.39 10.33 46 79992 60760 42480537
Congenital multiplex arthrogryposis 26.35 10.33 12 80026 261 42541036
Laryngeal oedema 26.32 10.33 35 80003 3973 42537324
Tooth infection 26.32 10.33 51 79987 7960 42533337
Rash scarlatiniform 26.24 10.33 10 80028 136 42541161
Constipation 26.03 10.33 188 79850 162103 42379194
Anaemia 25.73 10.33 371 79667 279907 42261390
Cheilitis 25.72 10.33 28 80010 2580 42538717
Ventricular enlargement 25.66 10.33 16 80022 667 42540630
Human herpesvirus 6 infection reactivation 25.66 10.33 14 80024 453 42540844
Hypersensitivity vasculitis 25.53 10.33 31 80007 3213 42538084
Inferior vena cava dilatation 25.37 10.33 17 80021 803 42540494
Bone disorder 25.36 10.33 45 79993 6568 42534729
Cardiac aneurysm 25.18 10.33 19 80019 1084 42540213
Ureteral disorder 25.17 10.33 10 80028 153 42541144
Derealisation 24.72 10.33 17 80021 838 42540459
Therapy partial responder 24.64 10.33 4 80034 20017 42521280
Faeces pale 24.64 10.33 22 80016 1592 42539705
Toothache 24.57 10.33 48 79990 7535 42533762
Liver function test abnormal 24.46 10.33 123 79915 32268 42509029
Ultrasound liver abnormal 24.34 10.33 9 80029 112 42541185
Pharyngeal oedema 24.19 10.33 42 79996 6026 42535271
Heart rate decreased 23.97 10.33 20 80018 36512 42504785
Febrile neutropenia 23.93 10.33 228 79810 185475 42355822
Joint warmth 23.92 10.33 15 80023 632 42540665
Chromaturia 23.70 10.33 75 79963 15914 42525383
Vasculitis 23.45 10.33 82 79956 18312 42522985
Odynophagia 23.35 10.33 44 79994 6726 42534571
Malignant mesenteric neoplasm 23.28 10.33 7 80031 43 42541254
Attention-seeking behaviour 23.28 10.33 7 80031 43 42541254
Conjunctival hyperaemia 22.83 10.33 29 80009 3147 42538150
Henoch-Schonlein purpura 22.82 10.33 24 80014 2126 42539171
Secondary amyloidosis 22.82 10.33 9 80029 135 42541162
Dental care 22.79 10.33 12 80026 361 42540936
Sensitisation 22.75 10.33 11 80027 275 42541022
Metastases to stomach 22.69 10.33 8 80030 86 42541211
Psoas abscess 22.53 10.33 16 80022 831 42540466
Dental caries 22.47 10.33 36 80002 4836 42536461
Vomiting 22.44 10.33 707 79331 289016 42252281
Erythema annulare 22.36 10.33 8 80030 90 42541207
COVID-19 22.32 10.33 127 79911 115821 42425476
Tachycardia foetal 22.29 10.33 12 80026 378 42540919
Normochromic normocytic anaemia 22.12 10.33 51 79987 8980 42532317
Total lung capacity abnormal 22.11 10.33 34 80004 4409 42536888
Macule 22.11 10.33 23 80015 2012 42539285
Cerebral palsy 22.03 10.33 12 80026 387 42540910
Capillary permeability increased 21.87 10.33 6 80032 25 42541272
Abscess oral 21.87 10.33 13 80025 497 42540800
Exposure during pregnancy 21.74 10.33 49 79989 8499 42532798
Deep vein thrombosis 21.69 10.33 73 79965 76884 42464413
Penile erythema 21.69 10.33 10 80028 224 42541073
Urticaria papular 21.46 10.33 8 80030 102 42541195
Enamel anomaly 21.41 10.33 10 80028 231 42541066
Eosinophilic granulomatosis with polyangiitis 21.40 10.33 49 79989 8589 42532708
Neurological symptom 20.81 10.33 53 79985 9938 42531359
Tubulointerstitial nephritis and uveitis syndrome 20.72 10.33 8 80030 113 42541184
Tooth hypoplasia 20.68 10.33 10 80028 250 42541047
Asthma 20.62 10.33 193 79845 62121 42479176
Encephalitis 20.57 10.33 50 79988 9108 42532189
Hyperglycaemia 20.54 10.33 34 80004 45825 42495472
Serum sickness 20.41 10.33 23 80015 2202 42539095
Productive cough 20.33 10.33 166 79872 51401 42489896
Palatal oedema 19.82 10.33 16 80022 1008 42540289
Foetal distress syndrome 19.78 10.33 17 80021 1169 42540128
Pulmonary alveolar haemorrhage 19.72 10.33 67 79971 14749 42526548
Otitis media 19.49 10.33 29 80009 3654 42537643
Blood pressure increased 19.43 10.33 112 79926 101816 42439481
Synovitis 19.41 10.33 3 80035 15564 42525733
Neutrophil count decreased 19.38 10.33 58 79980 63357 42477940
Coagulation factor decreased 19.31 10.33 7 80031 82 42541215
Jejunal ulcer perforation 19.31 10.33 7 80031 82 42541215
Blood pressure systolic decreased 19.21 10.33 34 80004 4953 42536344
Respiratory symptom 19.20 10.33 55 79983 11051 42530246
Hypertension 19.18 10.33 211 79827 166993 42374304
Pyelocaliectasis 19.16 10.33 18 80020 1391 42539906
Stoma closure 19.08 10.33 10 80028 298 42540999
Incorrect route of product administration 19.00 10.33 11 80027 24294 42517003
Crying 18.96 10.33 39 79999 6355 42534942
Haemoptysis 18.96 10.33 150 79888 46017 42495280
Spinal muscular atrophy 18.88 10.33 11 80027 405 42540892
Neoplasm progression 18.87 10.33 16 80022 28984 42512313
Capillaritis 18.70 10.33 22 80016 2206 42539091
Haemoglobin decreased 18.65 10.33 159 79879 132312 42408985
Sepsis 18.57 10.33 263 79775 199071 42342226
Plica syndrome 18.35 10.33 4 80034 4 42541293
Melanocytic hyperplasia 18.35 10.33 4 80034 4 42541293
Genital cyst 18.35 10.33 4 80034 4 42541293
Depression 18.33 10.33 128 79910 111235 42430062
Motor neurone disease 18.29 10.33 12 80026 547 42540750
Somnolence 18.27 10.33 173 79865 140932 42400365
Occult blood 18.23 10.33 15 80023 971 42540326
Laryngeal discomfort 18.19 10.33 9 80029 237 42541060
Cerebral infarction 18.16 10.33 19 80019 31150 42510147
Dental operation 17.99 10.33 11 80027 443 42540854
Pain 17.87 10.33 338 79700 244510 42296787
Rebound acid hypersecretion 17.81 10.33 7 80031 104 42541193
Maternal exposure during pregnancy 17.75 10.33 40 79998 6938 42534359
Conjunctivitis 17.65 10.33 59 79979 12880 42528417
Temperature intolerance 17.62 10.33 32 80006 4756 42536541
Omental necrosis 17.49 10.33 5 80033 25 42541272
Rash pustular 17.37 10.33 37 80001 6178 42535119
Prothrombin time shortened 17.33 10.33 18 80020 1571 42539726
Lymphocyte count decreased 17.30 10.33 16 80022 27793 42513504
Morganella infection 17.18 10.33 12 80026 607 42540690
Periorbital oedema 16.98 10.33 31 80007 4626 42536671
Dermatomyositis 16.83 10.33 18 80020 1625 42539672
Maple syrup disease 16.74 10.33 4 80034 8 42541289
Analgesic drug level increased 16.71 10.33 15 80023 1093 42540204
Conductive deafness 16.67 10.33 11 80027 506 42540791
Oral mucosal blistering 16.67 10.33 22 80016 2479 42538818
Alveolitis 16.63 10.33 19 80019 1846 42539451
Appendicitis 16.59 10.33 9 80029 20604 42520693
Eastern Cooperative Oncology Group performance status 16.59 10.33 5 80033 31 42541266
Sinusitis 16.42 10.33 148 79890 47144 42494153
Neuroleptic malignant syndrome 16.39 10.33 10 80028 21462 42519835
Tonsillitis 16.26 10.33 23 80015 2768 42538529
Sedation 16.21 10.33 20 80018 30455 42510842
Rectal abscess 16.20 10.33 18 80020 1697 42539600
Respiratory distress 16.15 10.33 134 79904 41686 42499611
Exostosis of external ear canal 16.13 10.33 4 80034 10 42541287
Ischaemic stroke 16.09 10.33 11 80027 22222 42519075
Bladder cancer 15.97 10.33 6 80032 17041 42524256
Product use issue 15.91 10.33 82 79956 76669 42464628
Sense of oppression 15.89 10.33 11 80027 548 42540749
Oral contusion 15.84 10.33 3 80035 0 42541297
Delinquency 15.84 10.33 3 80035 0 42541297
Dysphagia 15.70 10.33 207 79831 72512 42468785
Accessory auricle 15.60 10.33 4 80034 12 42541285
Drug dependence 15.58 10.33 19 80019 29075 42512222
Cerebral haemorrhage 15.56 10.33 31 80007 38935 42502362
Bronchial disorder 15.55 10.33 16 80022 1382 42539915
Skin oedema 15.46 10.33 12 80026 714 42540583
Cardiogenic shock 15.43 10.33 27 80011 35613 42505684
Pharyngitis 15.34 10.33 44 79994 8846 42532451
Diarrhoea haemorrhagic 15.14 10.33 40 79998 7667 42533630
Wrong drug 15.01 10.33 7 80031 161 42541136
Pyrexia 14.98 10.33 893 79145 393149 42148148
Blood creatine phosphokinase increased 14.92 10.33 44 79994 48294 42493003
Vanishing bile duct syndrome 14.92 10.33 18 80020 1853 42539444
Periostosis 14.91 10.33 4 80034 15 42541282
Osteonecrosis of jaw 14.85 10.33 73 79965 18976 42522321
Nephritis 14.81 10.33 26 80012 3763 42537534
Tumour lysis syndrome 14.79 10.33 12 80026 22219 42519078
Intentional product use issue 14.74 10.33 77 79961 71756 42469541
Swelling of eyelid 14.62 10.33 19 80019 2109 42539188
Maternal drugs affecting foetus 14.56 10.33 26 80012 3813 42537484
Lymphadenectomy 14.56 10.33 10 80028 492 42540805
Rhinitis allergic 14.55 10.33 26 80012 3816 42537481
Peritonsillar abscess 14.54 10.33 10 80028 493 42540804
Jarisch-Herxheimer reaction 14.40 10.33 12 80026 791 42540506
Orthostatic hypotension 14.31 10.33 22 80016 30548 42510749
Dermatosis 14.14 10.33 9 80029 389 42540908
Pharyngeal swelling 14.13 10.33 24 80014 3383 42537914
Treatment failure 14.08 10.33 65 79973 62559 42478738
Substance-induced mood disorder 14.00 10.33 5 80033 56 42541241
Hallucinations, mixed 13.99 10.33 24 80014 3411 42537886
Congenital heart valve disorder 13.92 10.33 5 80033 57 42541240
Hypocoagulable state 13.89 10.33 13 80025 1000 42540297
Cardiac hypertrophy 13.82 10.33 14 80024 1187 42540110
Tonsillar erythema 13.77 10.33 3 80035 3 42541294
Infusion site induration 13.76 10.33 9 80029 408 42540889
Diabetes mellitus 13.73 10.33 62 79976 60025 42481272
Anaphylactoid reaction 13.70 10.33 22 80016 2961 42538336
Genital erythema 13.67 10.33 8 80030 297 42541000
Impaired work ability 13.64 10.33 3 80035 12088 42529209
Dermatitis exfoliative 13.59 10.33 36 80002 6911 42534386
Abdominal distension 13.57 10.33 79 79959 71656 42469641
Gastritis 13.47 10.33 84 79954 23863 42517434
Ischaemic cerebral infarction 13.42 10.33 16 80022 1627 42539670
Forced expiratory volume decreased 13.40 10.33 38 80000 7592 42533705
Rectal polyp 13.36 10.33 11 80027 713 42540584
Persecutory delusion 13.34 10.33 24 80014 3540 42537757
Urinary retention 13.34 10.33 38 80000 42176 42499121
Throat tightness 13.30 10.33 44 79994 9555 42531742
Stridor 13.30 10.33 21 80017 2787 42538510
Tongue discolouration 13.29 10.33 14 80024 1242 42540055
Normocytic anaemia 13.28 10.33 24 80014 3553 42537744
Pneumococcal sepsis 13.28 10.33 15 80023 1440 42539857
Breath sounds 13.24 10.33 4 80034 25 42541272
Inflammatory marker increased 13.21 10.33 35 80003 6721 42534576
Depressed level of consciousness 13.18 10.33 46 79992 47924 42493373
Increased bronchial secretion 13.18 10.33 19 80019 2327 42538970
Neuropsychiatric syndrome 13.11 10.33 6 80032 132 42541165
Glycosylated haemoglobin increased 13.06 10.33 4 80034 12920 42528377
Ear swelling 13.03 10.33 10 80028 585 42540712
Blood glucose increased 12.98 10.33 83 79955 73616 42467681
Polyserositis 12.76 10.33 8 80030 337 42540960
Mixed anxiety and depressive disorder 12.57 10.33 7 80031 236 42541061
Senile dementia 12.50 10.33 4 80034 31 42541266
Cell death 12.48 10.33 21 80017 2938 42538359
Musculoskeletal stiffness 12.38 10.33 61 79977 57704 42483593
Red blood cell count decreased 12.25 10.33 27 80011 32688 42508609
Tongue eruption 12.24 10.33 3 80035 7 42541290
Cardiac arrest 12.12 10.33 139 79899 109181 42432116
Chest discomfort 12.07 10.33 177 79861 63439 42477858
Metastases to heart 12.02 10.33 6 80032 161 42541136
Hypophosphataemia 11.94 10.33 13 80025 20932 42520365
Cutaneous vasculitis 11.88 10.33 34 80004 6826 42534471
Genital lesion 11.86 10.33 7 80031 264 42541033
Dizziness exertional 11.84 10.33 7 80031 265 42541032
Mental status changes 11.83 10.33 40 79998 42075 42499222
Ocular icterus 11.76 10.33 21 80017 3080 42538217
Atrophic glossitis 11.70 10.33 3 80035 9 42541288
Chronic obstructive pulmonary disease 11.67 10.33 70 79968 63044 42478253
Sleep disorder due to a general medical condition 11.61 10.33 64 79974 17389 42523908
Pseudomembranous colitis 11.61 10.33 21 80017 3112 42538185
Lichenoid keratosis 11.60 10.33 24 80014 3926 42537371
Bronchial haemorrhage 11.56 10.33 10 80028 694 42540603
Acute respiratory failure 11.54 10.33 36 80002 38822 42502475
Hospitalisation 11.47 10.33 87 79951 74243 42467054
Bezoar 11.38 10.33 13 80025 1263 42540034
Balanitis candida 11.32 10.33 6 80032 183 42541114
Lower respiratory tract infection bacterial 11.32 10.33 9 80029 555 42540742
Chronic kidney disease 11.26 10.33 137 79901 47104 42494193
Congenital tracheomalacia 11.24 10.33 3 80035 11 42541286
Papule 11.20 10.33 30 80008 5796 42535501
Renal impairment 11.13 10.33 143 79895 110085 42431212
Alopecia 11.09 10.33 24 80014 29252 42512045
Altered state of consciousness 11.07 10.33 24 80014 29235 42512062
Contraindicated product administered 11.07 10.33 19 80019 25253 42516044
Nasal neoplasm 11.05 10.33 5 80033 107 42541190
Actinomycosis 11.04 10.33 9 80029 575 42540722
No adverse event 11.00 10.33 37 80001 38984 42502313
Prothrombin time ratio decreased 10.97 10.33 9 80029 580 42540717
Mycoplasma test positive 10.97 10.33 5 80033 109 42541188
Epstein-Barr virus antibody positive 10.89 10.33 7 80031 308 42540989
Infusion site swelling 10.86 10.33 21 80017 3271 42538026
Dental discomfort 10.84 10.33 5 80033 112 42541185
Hiatus hernia 10.77 10.33 38 80000 8522 42532775
Pulmonary artery dilatation 10.75 10.33 7 80031 315 42540982
Muscle contractions involuntary 10.74 10.33 16 80022 2018 42539279
Helicobacter gastritis 10.73 10.33 13 80025 1344 42539953
Sensation of foreign body 10.67 10.33 22 80016 3591 42537706
Ear infection 10.66 10.33 50 79988 12754 42528543
Clostridium difficile infection 10.64 10.33 76 79962 22583 42518714
Haematocrit decreased 10.61 10.33 32 80006 34876 42506421
Blood alkaline phosphatase increased 10.59 10.33 103 79935 33494 42507803
Lung disorder 10.58 10.33 137 79901 47786 42493511
Resuscitation 10.57 10.33 15 80023 1810 42539487
Haemolytic anaemia 10.57 10.33 48 79990 12079 42529218
Band sensation 10.57 10.33 5 80033 119 42541178
Diaphragmatic hernia 10.51 10.33 7 80031 327 42540970
Cyanosis neonatal 10.51 10.33 7 80031 327 42540970
Intestinal obstruction 10.51 10.33 22 80016 27136 42514161
Pulmonary sequestration 10.46 10.33 4 80034 55 42541242
Ascites 10.41 10.33 63 79975 56615 42484682
Balanoposthitis 10.41 10.33 14 80024 1607 42539690
Hyperleukocytosis 10.33 10.33 18 80020 2590 42538707

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 1242.16 9.52 1052 181418 81043 110325786
Anaphylactic shock 1186.44 9.52 847 181623 50699 110356130
Rash maculo-papular 1182.62 9.52 980 181490 73242 110333587
Angioedema 1014.34 9.52 1018 181452 97482 110309347
Pruritus 812.25 9.52 2450 180020 579110 109827719
Anaphylactic reaction 761.67 9.52 941 181529 113359 110293470
Erythema 752.84 9.52 1554 180916 289893 110116936
Acute generalised exanthematous pustulosis 698.24 9.52 439 182031 21225 110385604
Urticaria 661.40 9.52 1557 180913 317300 110089529
Type I hypersensitivity 587.15 9.52 261 182209 6132 110400697
Face oedema 566.56 9.52 458 182012 33011 110373818
Rash 550.14 9.52 2740 179730 818224 109588605
Swelling face 520.68 9.52 700 181770 91621 110315208
Lip oedema 519.83 9.52 253 182217 7347 110399482
Acute kidney injury 485.63 9.52 2204 180266 633226 109773603
Lip swelling 464.10 9.52 492 181978 50175 110356654
Crystalluria 449.77 9.52 142 182328 1213 110405616
Cross sensitivity reaction 437.79 9.52 204 182266 5363 110401466
Swollen tongue 421.40 9.52 509 181961 59853 110346976
Toxic skin eruption 406.43 9.52 348 182122 27167 110379662
Eosinophilia 395.42 9.52 483 181987 57453 110349376
Hepatocellular injury 393.28 9.52 451 182019 50191 110356638
Drug hypersensitivity 387.56 9.52 1629 180841 452461 109954368
Cholestasis 383.43 9.52 502 181968 64016 110342813
Toxic epidermal necrolysis 360.03 9.52 456 182014 56271 110350558
Synovitis 346.84 9.52 28 182442 274064 110132765
Type IV hypersensitivity reaction 319.61 9.52 169 182301 5864 110400965
Meningitis aseptic 310.48 9.52 197 182273 9673 110397156
Allergy test positive 307.49 9.52 97 182373 826 110406003
Pemphigus 271.22 9.52 22 182448 214548 110192281
Hepatic cytolysis 260.64 9.52 384 182086 54669 110352160
Pericarditis 254.69 9.52 31 182439 219083 110187746
Stevens-Johnson syndrome 248.27 9.52 345 182125 46556 110360273
Chronic sinusitis 241.12 9.52 250 182220 24834 110381995
Paraesthesia oral 233.44 9.52 283 182187 33388 110373441
Hand deformity 232.86 9.52 40 182430 218466 110188363
Death 230.66 9.52 507 181963 698362 109708467
Rash erythematous 221.01 9.52 445 182025 81387 110325442
Duodenal ulcer perforation 211.86 9.52 23 182447 177677 110229152
Tongue oedema 209.24 9.52 144 182326 8112 110398717
Jaundice 208.61 9.52 361 182109 58875 110347954
Rheumatoid factor positive 201.48 9.52 3 182467 131637 110275192
Rash pruritic 200.76 9.52 477 181993 97592 110309237
Wound closure 196.41 9.52 50 182420 171 110406658
Alopecia 195.56 9.52 188 182282 364565 110042264
Systemic lupus erythematosus 194.49 9.52 88 182382 254250 110152579
Wound 192.36 9.52 73 182397 234364 110172465
Tubulointerstitial nephritis 188.78 9.52 329 182141 53955 110352874
Rash morbilliform 188.23 9.52 133 182337 7818 110399011
Female genital tract fistula 187.10 9.52 180 182290 16339 110390490
Muscle injury 184.90 9.52 12 182458 140795 110266034
Glossodynia 182.36 9.52 69 182401 221935 110184894
Completed suicide 177.45 9.52 89 182381 242292 110164537
Osteotomy 177.00 9.52 50 182420 277 110406552
Psoriatic arthropathy 172.20 9.52 55 182415 196706 110210123
Therapeutic product effect decreased 171.07 9.52 95 182375 244221 110162608
Drug ineffective 169.05 9.52 1651 180819 1518889 108887940
Rheumatic fever 165.35 9.52 9 182461 122570 110284259
Dysphonia 164.89 9.52 378 182092 75551 110331278
Rash macular 164.89 9.52 257 182213 38429 110368400
Erythema multiforme 162.26 9.52 187 182283 20910 110385919
Folliculitis 159.43 9.52 40 182430 167613 110239216
Eyelid oedema 159.23 9.52 159 182311 15103 110391726
Arthropathy 159.02 9.52 144 182326 287378 110119451
Hepatitis cholestatic 156.25 9.52 168 182302 17398 110389431
Vaginal flatulence 156.15 9.52 142 182328 12002 110394827
Irritable bowel syndrome 152.67 9.52 41 182429 164174 110242655
Mobility decreased 150.04 9.52 104 182366 237318 110169511
Sleep disorder due to general medical condition, insomnia type 148.17 9.52 6 182464 105637 110301192
C-reactive protein abnormal 146.69 9.52 20 182450 129675 110277154
Fall 145.83 9.52 509 181961 602973 109803856
Fixed eruption 144.52 9.52 89 182381 4143 110402686
Enterocolitis haemorrhagic 143.79 9.52 75 182395 2529 110404300
Drug eruption 142.72 9.52 290 182180 53369 110353460
Rheumatoid arthritis 141.05 9.52 172 182298 299441 110107388
Dermatitis exfoliative generalised 138.54 9.52 127 182343 10845 110395984
Vaginal discharge 138.17 9.52 159 182311 17749 110389080
Radiculopathy 138.08 9.52 165 182305 19171 110387658
Macular degeneration 137.21 9.52 174 182296 21485 110385344
Stomatitis 133.81 9.52 149 182321 270093 110136736
Contraindicated product administered 132.96 9.52 128 182342 248139 110158690
Helicobacter infection 132.78 9.52 67 182403 181810 110225019
Skin test positive 132.55 9.52 59 182411 1390 110405439
Fibromyalgia 129.28 9.52 60 182410 170849 110235980
Proctitis 126.77 9.52 148 182322 16779 110390050
Ill-defined disorder 126.72 9.52 50 182420 156803 110250026
Discomfort 118.14 9.52 108 182362 214599 110192230
Kounis syndrome 117.37 9.52 89 182381 5836 110400993
Impaired healing 116.74 9.52 92 182378 196625 110210204
Vascular purpura 115.46 9.52 74 182396 3697 110403132
Fatigue 114.79 9.52 1370 181100 1214588 109192241
Acute hepatic failure 113.97 9.52 211 182259 36257 110370572
Product use issue 113.78 9.52 213 182257 311482 110095347
Breast cancer stage III 112.64 9.52 4 182466 79113 110327716
Dermatitis allergic 112.27 9.52 158 182312 21566 110385263
Mixed liver injury 111.81 9.52 118 182352 11961 110394868
Arthralgia 110.43 9.52 793 181677 778839 109627990
Blood cholesterol increased 110.18 9.52 86 182384 184699 110222130
Purpura 105.30 9.52 163 182307 24225 110382604
Lip dry 105.11 9.52 19 182451 100064 110306765
Hypersensitivity 104.84 9.52 1073 181397 402925 110003904
Infusion related reaction 104.20 9.52 304 182166 380858 110025971
Type 2 diabetes mellitus 103.77 9.52 84 182386 177148 110229681
Facet joint syndrome 102.52 9.52 18 182452 96810 110310019
Treatment failure 102.46 9.52 188 182282 277046 110129783
Hepatic enzyme increased 102.20 9.52 237 182233 320655 110086174
Abdominal discomfort 102.04 9.52 322 182148 393536 110013293
Serum sickness-like reaction 101.80 9.52 41 182429 747 110406082
Intentional product use issue 100.92 9.52 158 182312 247748 110159081
Malaise 100.09 9.52 1610 180860 670209 109736620
Oral candidiasis 98.46 9.52 224 182246 44536 110362293
Symmetrical drug-related intertriginous and flexural exanthema 97.27 9.52 52 182418 1845 110404984
Clostridium difficile colitis 96.20 9.52 219 182251 43559 110363270
Cholecystitis chronic 95.49 9.52 97 182373 9403 110397426
Grip strength decreased 93.97 9.52 11 182459 80163 110326666
Joint swelling 93.03 9.52 395 182075 442450 109964379
Laryngeal oedema 92.91 9.52 97 182373 9710 110397119
Hallucinations, mixed 91.49 9.52 91 182379 8602 110398227
Crystal nephropathy 89.93 9.52 49 182421 1807 110405022
Night sweats 89.63 9.52 55 182415 133928 110272901
Agranulocytosis 89.28 9.52 264 182206 61496 110345333
Rash papular 88.99 9.52 162 182308 27477 110379352
Weight increased 87.10 9.52 376 182094 419268 109987561
Clostridium difficile infection 86.27 9.52 234 182236 51895 110354934
Bronchospasm 85.90 9.52 168 182302 30071 110376758
Gait inability 84.47 9.52 61 182409 136315 110270514
Procedural pain 83.86 9.52 183 182287 35382 110371447
Palatal oedema 82.70 9.52 45 182425 1655 110405174
Wound infection 82.56 9.52 28 182442 96437 110310392
Malignant neoplasm progression 82.34 9.52 100 182370 174467 110232362
Bursitis 81.93 9.52 57 182413 129861 110276968
Allergy test negative 80.67 9.52 29 182441 381 110406448
Lower limb fracture 79.78 9.52 14 182456 75334 110331495
Myelosuppression 79.67 9.52 28 182442 94312 110312517
Amyloid arthropathy 77.67 9.52 43 182427 1637 110405192
Throat tightness 77.47 9.52 171 182299 33318 110373511
Joint range of motion decreased 77.43 9.52 53 182417 121779 110285050
Sputum increased 77.39 9.52 69 182401 5682 110401147
Dyspnoea 77.39 9.52 2380 180090 1104492 109302337
Dermatitis bullous 76.86 9.52 118 182352 17411 110389418
Drug abuse 76.14 9.52 109 182361 177302 110229527
Periorbital oedema 76.13 9.52 89 182381 10103 110396726
Peripheral venous disease 74.49 9.52 23 182447 84094 110322735
Gastrointestinal disorder 74.39 9.52 182 182288 241770 110165059
Emotional distress 72.90 9.52 200 182270 44647 110362182
Linear IgA disease 72.01 9.52 59 182411 4330 110402499
Chromaturia 71.43 9.52 153 182317 29207 110377622
Abdominal pain 71.36 9.52 1216 181254 511773 109895056
General physical health deterioration 70.03 9.52 413 182057 424882 109981947
Hypertension 69.14 9.52 525 181945 509559 109897270
Adverse event 68.26 9.52 48 182422 108761 110298068
Hypercholesterolaemia 66.98 9.52 33 182437 90804 110316025
Documented hypersensitivity to administered product 66.47 9.52 34 182436 1100 110405729
Prescribed overdose 65.82 9.52 31 182439 87550 110319279
Blepharospasm 65.61 9.52 7 182463 54844 110351985
Acute psychosis 65.46 9.52 59 182411 4928 110401901
Hepatitis acute 64.27 9.52 113 182357 18653 110388176
Off label use 64.11 9.52 1937 180533 1498248 108908581
Musculoskeletal stiffness 63.51 9.52 242 182228 279580 110127249
Nasopharyngitis 62.79 9.52 387 182083 393974 110012855
Contusion 62.37 9.52 188 182282 233173 110173656
Swelling 62.05 9.52 333 182137 350708 110056121
Injection site pain 61.92 9.52 125 182345 177797 110229032
Diarrhoea 61.21 9.52 2377 180093 1137128 109269701
Prescribed underdose 61.08 9.52 16 182454 65158 110341671
Peripheral swelling 60.50 9.52 404 182066 403630 110003199
International normalised ratio increased 60.06 9.52 293 182177 86479 110320350
Dislocation of vertebra 59.61 9.52 3 182467 43718 110363111
Incorrect route of product administration 59.51 9.52 16 182454 64045 110342784
Allergy to chemicals 59.44 9.52 47 182423 3278 110403551
Red blood cell sedimentation rate increased 58.41 9.52 28 182442 78274 110328555
Drug-induced liver injury 58.08 9.52 368 182102 119699 110287130
Migraine 57.71 9.52 123 182347 171529 110235300
Rash scarlatiniform 57.59 9.52 22 182448 346 110406483
Musculoskeletal pain 56.78 9.52 137 182333 182886 110223943
Thermal burn 56.76 9.52 68 182402 7920 110398909
Pharyngeal oedema 56.36 9.52 99 182371 16329 110390500
Flank pain 54.51 9.52 119 182351 23011 110383818
Tooth infection 54.31 9.52 116 182354 22100 110384729
Toxicity to various agents 53.74 9.52 520 181950 480035 109926794
Henoch-Schonlein purpura 53.48 9.52 46 182424 3611 110403218
Dental operation 52.80 9.52 32 182438 1447 110405382
Salpingo-oophorectomy unilateral 51.88 9.52 26 182444 805 110406024
Disease progression 51.60 9.52 217 182253 243817 110163012
Sciatica 51.37 9.52 46 182424 92353 110314476
Hypoaesthesia 51.24 9.52 306 182164 313917 110092912
Skin reaction 50.08 9.52 109 182361 21035 110385794
Spirometry abnormal 49.64 9.52 53 182417 5444 110401385
Conjunctivitis 49.36 9.52 145 182325 33647 110373182
Skin exfoliation 49.00 9.52 279 182191 87372 110319457
Mite allergy 48.99 9.52 54 182416 5749 110401080
Cheilitis 48.24 9.52 56 182414 6309 110400520
Pseudomembranous colitis 48.05 9.52 56 182414 6335 110400494
Mouth swelling 48.04 9.52 60 182410 7294 110399535
Epidermal necrosis 47.96 9.52 40 182430 3010 110403819
Hyperleukocytosis 47.75 9.52 42 182428 3397 110403432
Dysphagia 47.72 9.52 424 182046 153176 110253653
Blister 47.57 9.52 203 182267 227173 110179656
Enterocolitis 47.54 9.52 100 182370 18849 110387980
Inflammation 47.22 9.52 162 182308 193076 110213753
Drug interaction 47.21 9.52 1119 181351 499064 109907765
Odynophagia 47.12 9.52 84 182386 14017 110392812
Liver function test increased 46.97 9.52 46 182424 88502 110318327
Autoimmune disorder 46.47 9.52 25 182445 65458 110341371
Cholestatic liver injury 46.31 9.52 59 182411 7317 110399512
Vomiting 46.08 9.52 1888 180582 908787 109498042
Peritonsillar abscess 45.97 9.52 26 182444 1032 110405797
Loss of personal independence in daily activities 45.97 9.52 113 182357 149907 110256922
Liver function test abnormal 45.71 9.52 230 182240 68720 110338109
Tongue discolouration 45.33 9.52 44 182426 4037 110402792
Tubulointerstitial nephritis and uveitis syndrome 45.23 9.52 19 182451 387 110406442
Macule 44.98 9.52 42 182428 3671 110403158
Respiratory symptom 44.86 9.52 85 182385 14860 110391969
Pharyngeal swelling 44.55 9.52 75 182395 11957 110394872
Injection site erythema 44.34 9.52 54 182416 94122 110312707
Pyrexia 44.24 9.52 1857 180613 896408 109510421
Lupus vulgaris 44.14 9.52 3 182467 33880 110372949
Underdose 44.04 9.52 25 182445 63529 110343300
Therapeutic response decreased 43.70 9.52 57 182413 96442 110310387
Pulmonary vasculitis 43.62 9.52 54 182416 6506 110400323
Onychomadesis 43.19 9.52 11 182459 45652 110361177
Lymphadenopathy 43.07 9.52 214 182256 63621 110343208
Nail disorder 42.78 9.52 21 182449 57914 110348915
Obstructive airways disorder 42.71 9.52 170 182300 45979 110360850
Osteoarthritis 42.68 9.52 156 182314 182467 110224362
Helicobacter test positive 42.54 9.52 27 182443 1326 110405503
Dermatitis exfoliative 42.37 9.52 71 182399 11276 110395553
Degenerative mitral valve disease 42.30 9.52 17 182453 308 110406521
Skin candida 41.82 9.52 33 182437 2295 110404534
Conjunctivitis allergic 41.26 9.52 54 182416 6877 110399952
Otospondylomegaepiphyseal dysplasia 40.78 9.52 10 182460 28 110406801
Serum sickness 40.71 9.52 43 182427 4363 110402466
Adjustment disorder with depressed mood 40.69 9.52 11 182459 43872 110362957
Injection site reaction 39.93 9.52 53 182417 89017 110317812
Febrile neutropenia 39.65 9.52 333 182137 316434 110090395
Candida infection 39.06 9.52 170 182300 47839 110358990
Fluid retention 38.45 9.52 60 182410 94247 110312582
Crepitations 38.09 9.52 66 182404 10769 110396060
Bradycardia 37.57 9.52 131 182339 155386 110251443
Pulmonary pain 37.42 9.52 49 182421 6244 110400585
Sinusitis fungal 37.33 9.52 33 182437 2687 110404142
Rash pustular 37.32 9.52 72 182398 12757 110394072
Hip arthroplasty 37.20 9.52 23 182447 55790 110351039
Onychomycosis 36.99 9.52 9 182461 38522 110368307
Cardiac failure congestive 36.61 9.52 127 182343 150873 110255956
Tongue coated 36.50 9.52 28 182442 1868 110404961
Coeliac disease 36.15 9.52 13 182457 43174 110363655
Dust allergy 36.11 9.52 47 182423 5954 110400875
Oral discomfort 36.04 9.52 66 182404 11245 110395584
Macroglossia 35.89 9.52 25 182445 1436 110405393
Product quality issue 35.68 9.52 45 182425 77254 110329575
Back injury 35.27 9.52 17 182453 47382 110359447
Tooth disorder 35.16 9.52 118 182352 29391 110377438
Angiodermatitis 35.02 9.52 13 182457 188 110406641
Therapy partial responder 34.91 9.52 9 182461 37052 110369777
Drug intolerance 34.41 9.52 468 182002 406044 110000785
Drug tolerance decreased 34.29 9.52 3 182467 27537 110379292
Retinitis 34.24 9.52 6 182464 32321 110374508
Hepatitis 33.54 9.52 259 182211 89795 110317034
Localised oedema 33.50 9.52 57 182413 9166 110397663
Exostosis 33.42 9.52 17 182453 45939 110360890
Laryngeal discomfort 33.37 9.52 19 182451 764 110406065
Basilar artery occlusion 33.29 9.52 14 182456 286 110406543
Renal failure 33.24 9.52 542 181928 226032 110180797
Productive cough 33.19 9.52 311 182159 113994 110292835
Therapy non-responder 33.17 9.52 140 182330 157167 110249662
Osteonecrosis of jaw 33.12 9.52 162 182308 47855 110358974
Jaundice cholestatic 33.12 9.52 74 182396 14534 110392295
Infective exacerbation of chronic obstructive airways disease 32.84 9.52 33 182437 3157 110403672
Eczema 32.76 9.52 218 182252 72075 110334754
Cell death 32.75 9.52 44 182426 5747 110401082
Liver disorder 32.26 9.52 123 182347 142120 110264709
Chronic kidney disease 32.17 9.52 226 182244 76065 110330764
Subretinal haematoma 32.15 9.52 9 182461 48 110406781
Somatic delusion 32.09 9.52 18 182452 703 110406126
Condition aggravated 31.64 9.52 947 181523 733889 109672940
Toothache 31.46 9.52 98 182372 23477 110383352
Conjunctival irritation 31.42 9.52 11 182459 133 110406696
Platelet count decreased 31.25 9.52 237 182233 230206 110176623
Haemolytic anaemia 30.78 9.52 90 182380 20830 110385999
Chest discomfort 30.58 9.52 429 182041 173419 110233410
Live birth 30.49 9.52 42 182428 69442 110337387
Renal tubular necrosis 30.43 9.52 115 182355 30360 110376469
Asthenia 30.39 9.52 885 181585 688114 109718715
Pain 30.32 9.52 1278 181192 953677 109453152
Mycotic allergy 30.31 9.52 43 182427 5911 110400918
Gait disturbance 30.24 9.52 303 182167 277905 110128924
Anaphylactoid reaction 30.00 9.52 46 182424 6780 110400049
Synovial fluid analysis 29.96 9.52 29 182441 2652 110404177
Blood alkaline phosphatase increased 29.83 9.52 210 182260 70725 110336104
Frontal lobe epilepsy 29.69 9.52 8 182462 36 110406793
Bone erosion 29.69 9.52 20 182450 46351 110360478
Faeces pale 29.67 9.52 32 182438 3325 110403504
Maternal exposure during pregnancy 29.65 9.52 273 182197 254610 110152219
Injection site swelling 29.54 9.52 35 182435 61755 110345074
Prothrombin time ratio decreased 29.53 9.52 23 182447 1569 110405260
Conjunctival hyperaemia 29.52 9.52 42 182428 5789 110401040
Tenosynovitis stenosans 29.51 9.52 33 182437 3570 110403259
Ureteric compression 29.41 9.52 13 182457 301 110406528
Haematuria 29.41 9.52 236 182234 82769 110324060
Ventricular enlargement 29.34 9.52 17 182453 707 110406122
Injection site haemorrhage 29.29 9.52 9 182461 33019 110373810
Hepatic necrosis 29.25 9.52 56 182414 9866 110396963
Eye swelling 29.19 9.52 120 182350 32928 110373901
Biliary sepsis 28.62 9.52 24 182446 1819 110405010
Neuritis 28.57 9.52 47 182423 7352 110399477
Sleep disorder 28.52 9.52 201 182269 198443 110208386
Gamma-glutamyltransferase increased 28.46 9.52 186 182284 61123 110345706
Breast cancer 28.41 9.52 14 182456 38528 110368301
Lichen spinulosus 28.30 9.52 6 182464 6 110406823
Pulmonary vascular disorder 27.90 9.52 19 182451 1052 110405777
Sedation 27.78 9.52 45 182425 69638 110337191
Ear swelling 27.51 9.52 25 182445 2111 110404718
Central pain syndrome 27.38 9.52 17 182453 803 110406026
Inappropriate schedule of product administration 27.34 9.52 210 182260 203427 110203402
Bone disorder 27.28 9.52 87 182383 21105 110385724
Moraxella test positive 27.26 9.52 7 182463 25 110406804
Taste disorder 27.23 9.52 41 182429 65346 110341483
Inferior vena cava dilatation 27.21 9.52 18 182452 949 110405880
Pain in extremity 27.00 9.52 605 181865 486513 109920316
Lupus-like syndrome 26.92 9.52 17 182453 40775 110366054
Hepatic failure 26.89 9.52 200 182270 68539 110338290
Delirium 26.75 9.52 123 182347 134902 110271927
Swelling of eyelid 26.69 9.52 43 182427 6610 110400219
Hepatic cirrhosis 26.65 9.52 44 182426 67582 110339247
Muscle spasms 26.60 9.52 312 182158 277845 110128984
Memory impairment 26.49 9.52 203 182267 196741 110210088
Infectious mononucleosis 26.47 9.52 25 182445 2217 110404612
Colitis ulcerative 26.35 9.52 218 182252 77145 110329684
Orthostatic hypotension 26.20 9.52 43 182427 66206 110340623
Pharyngotonsillitis 26.12 9.52 12 182458 305 110406524
Sebaceous gland infection 26.08 9.52 10 182460 159 110406670
Pulmonary fibrosis 25.98 9.52 84 182386 101958 110304871
Cleft palate 25.92 9.52 13 182457 403 110406426
Muscle relaxant therapy 25.91 9.52 10 182460 162 110406667
Allergy to animal 25.81 9.52 23 182447 1893 110404936
Enamel anomaly 25.79 9.52 11 182459 233 110406596
Encephalitis 25.78 9.52 79 182391 18760 110388069
Blood pressure fluctuation 25.65 9.52 53 182417 74771 110332058
Neoplasm progression 25.48 9.52 42 182428 64553 110342276
Product use in unapproved indication 25.26 9.52 554 181916 446823 109960006
Hepatic ischaemia 25.24 9.52 19 182451 1232 110405597
Colitis 25.16 9.52 269 182201 102054 110304775
Road traffic accident 24.92 9.52 92 182378 107306 110299523
Frequent bowel movements 24.76 9.52 202 182268 71188 110335641
Vasculitis 24.72 9.52 121 182349 35752 110371077
Device expulsion 24.69 9.52 10 182460 30881 110375948
Total lung capacity abnormal 24.67 9.52 34 182436 4549 110402280
Adverse reaction 24.61 9.52 9 182461 29585 110377244
Pharyngitis 24.48 9.52 94 182376 25004 110381825
Neutropenic sepsis 24.35 9.52 108 182362 30638 110376191
Haemoptysis 24.26 9.52 201 182269 71153 110335676
Dry mouth 24.20 9.52 212 182258 199736 110207093
Oral mucosal eruption 24.02 9.52 18 182452 1159 110405670
Respiratory distress 23.95 9.52 195 182275 68679 110338150
Analgesic drug level increased 23.89 9.52 31 182439 3915 110402914
Lip and/or oral cavity cancer 23.85 9.52 18 182452 1172 110405657
Walking aid user 23.79 9.52 6 182464 25069 110381760
Dysentery 23.70 9.52 19 182451 1352 110405477
Blood pressure increased 23.49 9.52 293 182177 258080 110148749
Gallbladder disorder 23.23 9.52 82 182388 20947 110385882
Prostate cancer 23.09 9.52 17 182453 37624 110369205
Gingivitis 23.05 9.52 52 182418 10279 110396550
Neuroleptic malignant syndrome 22.74 9.52 14 182456 34045 110372784
Malignant mesenteric neoplasm 22.68 9.52 7 182463 55 110406774
Myalgia 22.64 9.52 503 181967 221878 110184951
Gastritis 22.59 9.52 159 182311 53540 110353289
Oral mucosal blistering 22.43 9.52 44 182426 7890 110398939
Excessive eye blinking 22.36 9.52 21 182449 1849 110404980
Normal tension glaucoma 22.36 9.52 7 182463 58 110406771
Sensation of foreign body 22.27 9.52 44 182426 7931 110398898
Bone marrow eosinophilic leukocyte count increased 22.27 9.52 6 182464 27 110406802
Nicotine dependence 22.06 9.52 18 182452 1313 110405516
Hiatus hernia 21.88 9.52 97 182373 27509 110379320
Diabetes mellitus 21.85 9.52 87 182383 99294 110307535
Hepatic perfusion disorder 21.85 9.52 7 182463 63 110406766
Tongue eruption 21.81 9.52 9 182461 175 110406654
Scleritis 21.70 9.52 35 182435 5385 110401444
Penile erythema 21.67 9.52 9 182461 178 110406651
Capillary permeability increased 21.65 9.52 7 182463 65 110406764
Cardiac aneurysm 21.64 9.52 20 182450 1725 110405104
Cognitive disorder 21.61 9.52 73 182397 87438 110319391
Coagulopathy 21.42 9.52 128 182342 40783 110366046
Muscular weakness 21.39 9.52 285 182185 248183 110158646
Jarisch-Herxheimer reaction 21.32 9.52 17 182453 1200 110405629
Acute febrile neutrophilic dermatosis 21.32 9.52 33 182437 4903 110401926
Abnormal faeces 21.18 9.52 47 182423 9189 110397640
Accidental exposure to product 21.17 9.52 31 182439 49977 110356852
Mouth ulceration 21.12 9.52 144 182326 47994 110358835
Cerebral infarction 21.11 9.52 33 182437 51805 110355024
Haematochezia 21.09 9.52 287 182183 115237 110291592
Muscle spasticity 21.04 9.52 17 182453 35898 110370931
Decreased appetite 21.01 9.52 611 181859 475235 109931594
Immune thrombocytopenia 20.92 9.52 83 182387 22411 110384418
Cutaneous vasculitis 20.92 9.52 57 182413 12672 110394157
Device malfunction 20.88 9.52 8 182462 25550 110381279
Factitious disorder 20.87 9.52 9 182461 196 110406633
Tinnitus 20.83 9.52 171 182299 60369 110346460
Lip pain 20.70 9.52 23 182447 2471 110404358
Osteoporosis 20.65 9.52 74 182396 87078 110319751
Acute respiratory failure 20.55 9.52 60 182410 75200 110331629
Myocardial infarction 20.53 9.52 210 182260 191873 110214956
Lip erosion 20.50 9.52 20 182450 1846 110404983
Joint warmth 20.46 9.52 21 182449 2061 110404768
Pyelocaliectasis 20.40 9.52 16 182454 1103 110405726
Lip ulceration 20.32 9.52 24 182446 2754 110404075
Amnesia 20.30 9.52 97 182373 105311 110301518
Antinuclear antibody positive 20.29 9.52 46 182424 9122 110397707
Human herpesvirus 6 infection reactivation 20.27 9.52 16 182454 1113 110405716
Finger deformity 20.23 9.52 15 182455 33077 110373752
Tonsillitis 20.21 9.52 43 182427 8170 110398659
Urinary retention 20.18 9.52 54 182416 69629 110337200
Psoas abscess 20.17 9.52 18 182452 1484 110405345
Pulmonary artery stenosis congenital 20.14 9.52 5 182465 15 110406814
Photophobia 20.01 9.52 90 182380 25681 110381148
Influenza B virus test positive 20.01 9.52 11 182459 413 110406416
Normochromic normocytic anaemia 20.01 9.52 57 182413 13000 110393829
Clostridium colitis 20.00 9.52 26 182444 3289 110403540
Rectal haemorrhage 19.99 9.52 293 182177 119540 110287289
Spinal muscular atrophy 19.93 9.52 11 182459 416 110406413
Actinomycosis 19.89 9.52 17 182453 1323 110405506
Nephritis 19.84 9.52 36 182434 6090 110400739
Eosinophilic granulomatosis with polyangiitis 19.75 9.52 50 182420 10636 110396193
Arthritis 19.70 9.52 179 182291 167407 110239422
Confusional state 19.65 9.52 606 181864 468074 109938755
Tooth discolouration 19.64 9.52 17 182453 1346 110405483
Oropharyngeal pain 19.60 9.52 323 182147 134953 110271876
Multiple sclerosis relapse 19.51 9.52 33 182437 50207 110356622
Pharyngitis streptococcal 19.42 9.52 57 182413 13220 110393609
Brain stem auditory evoked response abnormal 19.40 9.52 4 182466 3 110406826
Capillaritis 19.40 9.52 22 182448 2417 110404412
Vanishing bile duct syndrome 19.35 9.52 25 182445 3143 110403686
Allergic hepatitis 19.35 9.52 6 182464 48 110406781
Pharyngeal erythema 19.22 9.52 21 182449 2214 110404615
Inflammatory marker increased 19.17 9.52 60 182410 14409 110392420
Transaminases increased 19.17 9.52 174 182296 63216 110343613
Lichenoid keratosis 19.11 9.52 36 182434 6266 110400563
Circulatory collapse 19.09 9.52 129 182341 42864 110363965
Abdominal wall haematoma 19.08 9.52 34 182436 5671 110401158
Ureteral disorder 19.06 9.52 12 182458 581 110406248
Laryngeal dyspnoea 18.93 9.52 10 182460 346 110406483
Tooth hypoplasia 18.91 9.52 10 182460 347 110406482
Plica syndrome 18.87 9.52 4 182466 4 110406825
Photosensitivity reaction 18.86 9.52 88 182382 25501 110381328
Porphyria acute 18.80 9.52 4 182466 18776 110388053
Synovial disorder 18.80 9.52 24 182446 2983 110403846
Blood test abnormal 18.71 9.52 12 182458 28542 110378287
Injection site pruritus 18.70 9.52 35 182435 51223 110355606
Ultrasound liver abnormal 18.69 9.52 8 182462 171 110406658
Foot deformity 18.68 9.52 32 182438 48448 110358381
Posterior reversible encephalopathy syndrome 18.65 9.52 17 182453 33844 110372985
Pregnancy on oral contraceptive 18.51 9.52 14 182456 914 110405915
Depressed level of consciousness 18.46 9.52 109 182361 112169 110294660
Attention-seeking behaviour 18.45 9.52 7 182463 108 110406721
Sedation complication 18.36 9.52 5 182465 19850 110386979
Papule 18.30 9.52 47 182423 10086 110396743
Right ventricular failure 18.28 9.52 10 182460 25944 110380885
Embolism venous 18.18 9.52 31 182439 4992 110401837
Quality of life decreased 18.08 9.52 58 182412 14111 110392718
Prothrombin time shortened 18.07 9.52 26 182444 3620 110403209
Pneumonia mycoplasmal 17.91 9.52 18 182452 1723 110405106
Oxygen saturation decreased 17.88 9.52 169 182301 156813 110250016
Joint dislocation 17.86 9.52 18 182452 34172 110372657
Biliary dyskinesia 17.85 9.52 21 182449 2400 110404429
Jejunal ulcer perforation 17.82 9.52 7 182463 119 110406710
Oropharyngeal discomfort 17.73 9.52 47 182423 10280 110396549
Urticaria papular 17.69 9.52 9 182461 288 110406541
Obesity 17.61 9.52 112 182358 113239 110293590
Oliguria 17.48 9.52 69 182401 18588 110388241
Subarachnoid haemorrhage 17.47 9.52 14 182456 29688 110377141
Stoma closure 17.36 9.52 10 182460 411 110406418
Fear-related avoidance of activities 17.31 9.52 7 182463 129 110406700
Rhabdomyolysis 17.27 9.52 287 182183 120114 110286715
Maple syrup disease 17.25 9.52 4 182466 8 110406821
Insomnia 17.19 9.52 458 182012 360132 110046697
Blood glucose increased 17.15 9.52 138 182332 132358 110274471
Bronchiectasis 17.10 9.52 21 182449 36472 110370357
Pharyngeal abscess 17.04 9.52 13 182457 860 110405969
Depression 17.04 9.52 396 182074 316939 110089890
White blood cell count decreased 16.99 9.52 271 182199 229119 110177710
Eye pain 16.97 9.52 141 182329 49958 110356871
Device leakage 16.95 9.52 3 182467 16045 110390784
Pulmonary alveolar haemorrhage 16.89 9.52 72 182398 20078 110386751
Motor neurone disease 16.88 9.52 12 182458 712 110406117
Oral mucosal hypertrophy 16.83 9.52 5 182465 34 110406795
Atelectasis 16.81 9.52 111 182359 36601 110370228
Tenosynovitis 16.72 9.52 62 182408 16221 110390608
Hypersensitivity vasculitis 16.70 9.52 36 182434 6901 110399928
Pancreatic failure 16.66 9.52 20 182450 2334 110404495
Abnormal behaviour 16.66 9.52 116 182354 38923 110367906
Exostosis of external ear canal 16.64 9.52 4 182466 10 110406819
Tremor 16.54 9.52 444 182026 201788 110205041
Injection site rash 16.53 9.52 9 182461 23410 110383419
Substance-induced mood disorder 16.41 9.52 6 182464 83 110406746
Secondary amyloidosis 16.37 9.52 9 182461 338 110406491
Lung neoplasm malignant 16.36 9.52 19 182451 33823 110373006
Post transplant lymphoproliferative disorder 16.31 9.52 3 182467 15610 110391219
Pneumonia 16.25 9.52 1236 181234 875478 109531351
Deformity 16.20 9.52 45 182425 10115 110396714
Neutrophil toxic granulation present 16.19 9.52 8 182462 240 110406589
Lymphadenitis 16.19 9.52 31 182439 5462 110401367
Choluria 16.15 9.52 10 182460 470 110406359
Omental necrosis 16.12 9.52 5 182465 40 110406789
Melanocytic hyperplasia 16.11 9.52 4 182466 12 110406817
Varicella 16.07 9.52 25 182445 3730 110403099
Anhedonia 16.05 9.52 59 182411 15369 110391460
Hypoaesthesia oral 16.03 9.52 63 182407 16939 110389890
No adverse event 16.01 9.52 65 182405 73774 110333055
Pregnancy 16.01 9.52 38 182432 51029 110355800
Hyperaemia 15.98 9.52 25 182445 3748 110403081
Forced expiratory volume decreased 15.97 9.52 53 182417 13123 110393706
Hospitalisation 15.97 9.52 154 182316 142339 110264490
Mental status changes 15.89 9.52 68 182402 76054 110330775
Ocular hyperaemia 15.76 9.52 115 182355 39171 110367658
Suspected suicide 15.71 9.52 3 182467 15196 110391633
Mania 15.68 9.52 72 182398 20724 110386105
Drug tolerance 15.68 9.52 4 182466 16581 110390248
Otitis media acute 15.62 9.52 16 182454 1566 110405263
Blood uric acid increased 15.60 9.52 8 182462 21521 110385308
Vertebrobasilar insufficiency 15.58 9.52 9 182461 372 110406457
Hyperthermia 15.56 9.52 73 182397 21199 110385630
Alveolitis 15.55 9.52 27 182443 4412 110402417
Persecutory delusion 15.55 9.52 33 182437 6258 110400571
Bladder cancer 15.53 9.52 7 182463 20285 110386544
Bipolar I disorder 15.51 9.52 19 182451 2264 110404565
Knee arthroplasty 15.48 9.52 55 182415 64893 110341936
Ulcer haemorrhage 15.46 9.52 9 182461 22562 110384267
Periostosis 15.43 9.52 4 182466 15 110406814
Prurigo 15.37 9.52 15 182455 1385 110405444
Fibrous histiocytoma 15.30 9.52 12 182458 827 110406002
Product dose omission issue 15.26 9.52 409 182061 321373 110085456
Ocular icterus 15.25 9.52 32 182438 6021 110400808
Transplant rejection 15.19 9.52 11 182459 24556 110382273
Polymenorrhagia 15.14 9.52 5 182465 50 110406779
Ureteric obstruction 15.14 9.52 22 182448 3092 110403737
Oedema mouth 15.05 9.52 22 182448 3108 110403721
Nasal polyps 15.04 9.52 52 182418 13148 110393681
Staphylococcal scalded skin syndrome 14.99 9.52 10 182460 535 110406294
Idiopathic urticaria 14.93 9.52 8 182462 285 110406544
Petechiae 14.90 9.52 77 182393 23240 110383589
Mucosal pain 14.88 9.52 5 182465 53 110406776
Budd-Chiari syndrome 14.81 9.52 6 182464 111 110406718
Wound complication 14.81 9.52 32 182438 6145 110400684
Foetal exposure during pregnancy 14.80 9.52 36 182434 7469 110399360
Cardiac failure 14.80 9.52 219 182251 187407 110219422
Infection 14.76 9.52 470 182000 361730 110045099
Drug dose omission by device 14.72 9.52 3 182467 14513 110392316
Visual snow syndrome 14.63 9.52 5 182465 56 110406773
Nephritis allergic 14.63 9.52 13 182457 1066 110405763
Lung disorder 14.60 9.52 209 182261 179838 110226991
Erythema annulare 14.51 9.52 8 182462 302 110406527
Pseudofolliculitis 14.50 9.52 4 182466 20 110406809
Metastases to stomach 14.42 9.52 8 182462 306 110406523
Product storage error 14.41 9.52 9 182461 21719 110385110
Labile blood pressure 14.32 9.52 19 182451 2452 110404377
Laryngeal obstruction 14.25 9.52 6 182464 123 110406706
Fracture 14.19 9.52 12 182458 24776 110382053
Serotonin syndrome 14.16 9.52 50 182420 59103 110347726
Varicose veins pelvic 14.15 9.52 3 182467 3 110406826
Adverse drug reaction 14.10 9.52 109 182361 105450 110301379
Enanthema 14.07 9.52 13 182457 1121 110405708
Tryptase increased 14.07 9.52 12 182458 931 110405898
Delayed delivery 14.03 9.52 4 182466 23 110406806
Femoral artery embolism 13.89 9.52 5 182465 66 110406763
Otitis media 13.84 9.52 35 182435 7441 110399388
Premature baby 13.82 9.52 27 182443 4828 110402001
Parotid gland enlargement 13.77 9.52 13 182457 1152 110405677
Reaction to excipient 13.77 9.52 17 182453 2042 110404787
Caffeine allergy 13.75 9.52 4 182466 25 110406804
Adrenal insufficiency 13.72 9.52 31 182439 42359 110364470
Eosinophils urine present 13.68 9.52 5 182465 69 110406760
Chapped lips 13.63 9.52 21 182449 3107 110403722
Strawberry tongue 13.62 9.52 4 182466 26 110406803
PRIDE syndrome 13.62 9.52 4 182466 26 110406803
Genital erythema 13.61 9.52 8 182462 342 110406487
Small intestinal obstruction 13.61 9.52 20 182450 32193 110374636
Disability 13.53 9.52 18 182452 30205 110376624
Genital erosion 13.51 9.52 11 182459 800 110406029
Hepatic enzyme decreased 13.44 9.52 12 182458 990 110405839
Tendon disorder 13.37 9.52 37 182433 8300 110398529
Campylobacter infection 13.34 9.52 18 182452 2361 110404468
Injection site warmth 13.33 9.52 6 182464 17399 110389430
Palatal swelling 13.21 9.52 7 182463 244 110406585
Schizophrenia 13.20 9.52 10 182460 21816 110385013
Hepatomegaly 13.19 9.52 70 182400 21344 110385485
Nail dystrophy 13.19 9.52 13 182457 1215 110405614
Creatinine renal clearance decreased 13.19 9.52 10 182460 21805 110385024
Exposure via breast milk 13.18 9.52 12 182458 1016 110405813
Pneumopericardium 13.15 9.52 7 182463 246 110406583
Multiple lentigines syndrome 13.08 9.52 7 182463 249 110406580
Metastases to liver 13.05 9.52 24 182446 35362 110371467
Alexithymia 13.01 9.52 4 182466 31 110406798
Drug withdrawal syndrome 13.01 9.52 27 182443 38027 110368802
Newcastle disease 12.94 9.52 3 182467 6 110406823
Atrial septal defect 12.85 9.52 17 182453 2188 110404641
Pneumococcal sepsis 12.81 9.52 17 182453 2195 110404634
Genital lesion 12.75 9.52 9 182461 528 110406301
Electrocardiogram QRS complex prolonged 12.58 9.52 3 182467 13018 110393811
Lung consolidation 12.58 9.52 42 182428 10434 110396395
Incision site haemorrhage 12.50 9.52 12 182458 1086 110405743
Sweat discolouration 12.39 9.52 4 182466 37 110406792
Temperature regulation disorder 12.30 9.52 3 182467 12823 110394006
Leukocyturia 12.29 9.52 17 182453 2283 110404546
Transient ischaemic attack 12.25 9.52 59 182411 63923 110342906
Pneumonia aspiration 12.25 9.52 81 182389 81152 110325677
Drug ineffective for unapproved indication 12.22 9.52 238 182232 102600 110304229
Target skin lesion 12.17 9.52 7 182463 287 110406542
Claudication of jaw muscles 12.13 9.52 5 182465 97 110406732
Electrocardiogram QT prolonged 12.11 9.52 118 182352 108842 110297987
Balanitis candida 12.08 9.52 6 182464 182 110406647
Progressive multifocal leukoencephalopathy 12.08 9.52 14 182456 24942 110381887
Hyperphosphataemia 12.00 9.52 6 182464 16375 110390454
Balanoposthitis 11.96 9.52 13 182457 1363 110405466
Gangrene 11.95 9.52 6 182464 16335 110390494
Occult blood 11.90 9.52 15 182455 1841 110404988
Newborn persistent pulmonary hypertension 11.84 9.52 3 182467 10 110406819
Choking sensation 11.82 9.52 24 182446 4412 110402417
Enthesopathy 11.81 9.52 3 182467 12475 110394354
Hypophosphataemia 11.81 9.52 23 182447 33159 110373670
Breast cancer female 11.80 9.52 3 182467 12465 110394364
SJS-TEN overlap 11.78 9.52 15 182455 1859 110404970
Tympanic membrane perforation 11.75 9.52 16 182454 2116 110404713
COVID-19 11.74 9.52 311 182159 244749 110162080
Altered state of consciousness 11.71 9.52 52 182418 57574 110349255
Renal colic 11.65 9.52 20 182450 3238 110403591
Rectal abscess 11.61 9.52 18 182452 2678 110404151
Abdominal pain lower 11.61 9.52 103 182367 37180 110369649
Derealisation 11.60 9.52 16 182454 2142 110404687
Injection site urticaria 11.60 9.52 7 182463 17208 110389621
Intentional product misuse 11.59 9.52 152 182318 132752 110274077
Psychotic behaviour 11.58 9.52 13 182457 1412 110405417
Pulmonary mass 11.50 9.52 28 182442 37273 110369556
Akathisia 11.47 9.52 7 182463 17106 110389723
Acute myopia 11.46 9.52 6 182464 204 110406625
Intestinal obstruction 11.45 9.52 47 182423 53180 110353649
Blood pressure systolic increased 11.41 9.52 85 182385 82906 110323923
Anuria 11.39 9.52 74 182396 24267 110382562
Tongue blistering 11.39 9.52 15 182455 1922 110404907
Tonsillar hypertrophy 11.38 9.52 15 182455 1923 110404906
Tooth extraction 11.34 9.52 47 182423 12944 110393885
Thought insertion 11.31 9.52 4 182466 50 110406779
Nephrogenic anaemia 11.30 9.52 24 182446 4553 110402276
Personal relationship issue 11.30 9.52 6 182464 210 110406619
Nail infection 11.26 9.52 17 182453 2471 110404358
Biliary colic 11.23 9.52 24 182446 4573 110402256
Parkinsonism 11.23 9.52 12 182458 22175 110384654
Bronchial disorder 11.22 9.52 18 182452 2758 110404071
Antibiotic level above therapeutic 11.22 9.52 11 182459 1022 110405807
Eyelid haematoma 11.19 9.52 5 182465 119 110406710
Skin swelling 11.16 9.52 34 182436 8046 110398783
Clostridial infection 11.14 9.52 29 182441 6273 110400556
Kidney transplant rejection 11.12 9.52 3 182467 11984 110394845
Neuropsychiatric syndrome 11.12 9.52 6 182464 217 110406612
Emphysema 11.11 9.52 63 182407 19693 110387136
Cholestasis of pregnancy 11.08 9.52 12 182458 1253 110405576
Type III immune complex mediated reaction 11.04 9.52 11 182459 1042 110405787
Skin oedema 11.02 9.52 15 182455 1984 110404845
Haemolytic uraemic syndrome 11.02 9.52 25 182445 4960 110401869
Bone density decreased 10.97 9.52 54 182416 15988 110390841
HCoV-OC43 infection 10.96 9.52 4 182466 55 110406774
Central nervous system lesion 10.94 9.52 6 182464 15547 110391282
Epilepsy 10.93 9.52 109 182361 100100 110306729
Eye oedema 10.89 9.52 17 182453 2545 110404284
Body fat disorder 10.88 9.52 7 182463 352 110406477
Viral rash 10.86 9.52 8 182462 502 110406327
Psoriasis 10.83 9.52 164 182306 139829 110267000
Oedema peripheral 10.82 9.52 654 181816 328006 110078823
Arteriosclerosis 10.81 9.52 74 182396 24693 110382136
Bleeding time prolonged 10.79 9.52 12 182458 1290 110405539
Tongue pruritus 10.77 9.52 10 182460 868 110405961
Lower respiratory tract infection bacterial 10.76 9.52 11 182459 1074 110405755
Systolic dysfunction 10.73 9.52 23 182447 4392 110402437
Dental care 10.73 9.52 11 182459 1078 110405751
Papillary renal cell carcinoma 10.70 9.52 7 182463 362 110406467
Pancreatitis acute 10.70 9.52 149 182321 60125 110346704
Respiratory failure 10.65 9.52 272 182198 215060 110191769
Genital cyst 10.64 9.52 4 182466 60 110406769
Herpes zoster 10.57 9.52 121 182349 108258 110298571
Neuropsychiatric lupus 10.57 9.52 6 182464 240 110406589
Red blood cell sedimentation rate decreased 10.55 9.52 12 182458 1322 110405507
Acquired haemophilia 10.55 9.52 17 182453 2614 110404215
Lower gastrointestinal haemorrhage 10.52 9.52 9 182461 18477 110388352
Synovial cyst 10.49 9.52 42 182428 11388 110395441
Hypocalcaemia 10.46 9.52 64 182406 65302 110341527
Respiratory tract oedema 10.45 9.52 11 182459 1112 110405717
Glossitis 10.43 9.52 23 182447 4478 110402351
Meningoencephalitis viral 10.39 9.52 8 182462 537 110406292
Blindness cortical 10.35 9.52 11 182459 1124 110405705
Heart rate decreased 10.34 9.52 87 182383 82669 110324160
Eastern Cooperative Oncology Group performance status 10.31 9.52 5 182465 144 110406685
Post-traumatic stress disorder 10.31 9.52 29 182441 6567 110400262
Neurological symptom 10.30 9.52 52 182418 15556 110391273
Loefgren syndrome 10.28 9.52 5 182465 145 110406684
Troponin increased 10.27 9.52 21 182449 29745 110377084
Penile blister 10.24 9.52 4 182466 67 110406762
Morganella infection 10.23 9.52 12 182458 1367 110405462
Uterine contractions abnormal 10.21 9.52 5 182465 147 110406682
Cerebral haemorrhage 10.19 9.52 64 182406 64904 110341925
Hysterectomy 10.16 9.52 33 182437 8081 110398748
Pleuritic pain 10.11 9.52 53 182417 16087 110390742
Hepatorenal syndrome 10.10 9.52 23 182447 4574 110402255
Metastases to lung 10.06 9.52 14 182456 23049 110383780
Laryngitis 10.05 9.52 36 182434 42375 110364454
Mycoplasma test positive 10.05 9.52 6 182464 264 110406565
Deafness 10.04 9.52 77 182393 26632 110380197
Skin odour abnormal 10.04 9.52 16 182454 2438 110404391
Therapy cessation 10.03 9.52 39 182431 44818 110362011
Epidermolysis 10.01 9.52 11 182459 1167 110405662
Blood calcium increased 10.00 9.52 9 182461 18031 110388798
Hand-foot-and-mouth disease 9.99 9.52 9 182461 751 110406078
Atrophy 9.99 9.52 16 182454 2448 110404381
Forced vital capacity abnormal 9.98 9.52 4 182466 72 110406757
Cushingoid 9.93 9.52 42 182428 11670 110395159
Hemiparesis 9.93 9.52 38 182432 43865 110362964
Meningism 9.90 9.52 9 182461 760 110406069
Mucosal discolouration 9.89 9.52 10 182460 964 110405865
Transverse sinus thrombosis 9.81 9.52 9 182461 769 110406060
Hydronephrosis 9.78 9.52 63 182407 20602 110386227
Foot fracture 9.72 9.52 17 182453 25529 110381300
Normocytic anaemia 9.68 9.52 28 182442 6439 110400390
Ear, nose and throat examination abnormal 9.67 9.52 3 182467 24 110406805
Lymphocytosis 9.67 9.52 25 182445 5386 110401443
Aplastic anaemia 9.66 9.52 71 182399 24237 110382592
Antineutrophil cytoplasmic antibody positive 9.64 9.52 24 182446 5052 110401777
Infusion site reaction 9.59 9.52 9 182461 17673 110389156
Tumour lysis syndrome 9.59 9.52 23 182447 30778 110376051
Nodule 9.58 9.52 89 182381 32542 110374287
Diarrhoea haemorrhagic 9.55 9.52 51 182419 15588 110391241
Allergy to arthropod bite 9.55 9.52 7 182463 436 110406393
Diabetic retinal oedema 9.53 9.52 7 182463 437 110406392
Oedema mucosal 9.53 9.52 15 182455 2261 110404568
Dermatosis 9.52 9.52 10 182460 1008 110405821

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Gastrointestinal disorder 26.39 26.29 6 515 0 113432
Klebsiella infection 26.39 26.29 6 515 0 113432

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 A02BD17 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:22587 antiviral agent
CHEBI has role CHEBI:33231 antitubercular agent
CHEBI has role CHEBI:33281 antimicrobial agent
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:36047 antibacterial drug
CHEBI has role CHEBI:38068 antimalarial
CHEBI has role CHEBI:49201 anti-ulcer drug
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:74518 anti-obesity agent
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000900 Anti-Bacterial Agents

Related Drugs by ATC class:

A02BD Combinations for eradication of Helicobacter pylori 13 drugs
bismuth subcitrateclarithromycinesomeprazolelansoprazolelevofloxacinmetronidazoleomeprazolepantoprazolerabeprazolerifabutintetracyclinetinidazole show all 13 →
J01CA Penicillins with extended spectrum 18 drugs
ampicillinaspoxicillinazlocillinbacampicillincarbenicillincarindacillinepicillinhetacillinmecillinammetampicillinmezlocillinpiperacillin show all 18 →
J01CR Combinations of penicillins, incl. beta-lactamase inhibitors 4 drugs
ampicillinpiperacillinsultamicillinticarcillin

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




🐶 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

🐶 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 TALICIA HOLDINGS 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 TALICIA HOLDINGS N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 11931463 Feb. 12, 2034 TREATMENT OF HELICOBACTER PYLORI INFECTION IN ADULTS USING SPECIFIED DOSAGE FORM
250MG;EQ 10MG BASE;12.5MG TALICIA TALICIA HOLDINGS 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 TALICIA HOLDINGS 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 TALICIA HOLDINGS N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 9603806 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS
250MG;EQ 10MG BASE;12.5MG TALICIA TALICIA HOLDINGS N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 11878011 May 27, 2042 TREATMENT OF HELICOBACTER PYLORI INFECTION USING THE ADMINISTERED DOSAGE FORMS IN ADULTS WITH DIFFERENT BODY MASS INDEX DETERMINATIONS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
250MG;EQ 10MG BASE;12.5MG TALICIA TALICIA HOLDINGS N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL Nov. 1, 2022 NEW PRODUCT
500MG;500MG;EQ 20MG BASE VOQUEZNA TRIPLE PAK PHATHOM N215152 May 3, 2022 RX CAPSULE, TABLET, TABLET ORAL May 3, 2027 NEW CHEMICAL ENTITY
500MG;EQ 20MG BASE VOQUEZNA DUAL PAK PHATHOM N215153 May 3, 2022 RX CAPSULE, TABLET ORAL May 3, 2027 NEW CHEMICAL ENTITY
250MG;EQ 10MG BASE;12.5MG TALICIA TALICIA HOLDINGS N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL Nov. 1, 2027 GENERATING ANTIBIOTIC INCENTIVES NOW
500MG;500MG;EQ 20MG BASE VOQUEZNA TRIPLE PAK PHATHOM N215152 May 3, 2022 RX CAPSULE, TABLET, TABLET ORAL May 3, 2032 GENERATING ANTIBIOTIC INCENTIVES NOW
500MG;EQ 20MG BASE VOQUEZNA DUAL PAK PHATHOM N215153 May 3, 2022 RX 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
61336-70-7 SECONDARY_CAS_RN
34642-77-8 SECONDARY_CAS_RN
1297882 RXNORM
C0002645 UMLSCUI
CHEBI:2676 CHEBI
CHEMBL1082 ChEMBL_ID
CHEMBL2105950 ChEMBL_ID
DB01060 DRUGBANK_ID
D000658 MESH_DESCRIPTOR_UI
33613 PUBCHEM_CID
10895 IUPHAR_LIGAND_ID
804826J2HU UNII
11786 MMSL
3600 MMSL
4187 MMSL
d00088 MMSL
AXL PDB_CHEM_ID
3230 INN_ID
4017604 VANDF
4017605 VANDF
002707 NDDF
003675 NDDF
003718 NDDF
27658006 SNOMEDCT_US
372687004 SNOMEDCT_US
427483001 SNOMEDCT_US
785686003 SNOMEDCT_US
96068000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2263 TABLET, FILM COATED 500 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2263 TABLET, FILM COATED 500 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2264 TABLET, FILM COATED 875 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2264 TABLET, FILM COATED 875 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 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 0093-2277 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 HUMAN PRESCRIPTION DRUG LABEL 1 0093-3107 CAPSULE 250 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-3107 CAPSULE 250 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-3109 CAPSULE 500 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-3109 CAPSULE 500 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4155 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4155 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4160 POWDER, FOR SUSPENSION 200 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4160 POWDER, FOR SUSPENSION 200 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4161 POWDER, FOR SUSPENSION 400 mg ORAL ANDA 27 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4161 POWDER, FOR SUSPENSION 400 mg ORAL ANDA 27 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-8675 POWDER, FOR SUSPENSION 600 mg ORAL ANDA 26 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0143-9249 TABLET 875 mg ORAL ANDA 28 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0143-9249 TABLET 875 mg ORAL ANDA 28 sections
Amoxicillin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9285 TABLET, COATED 875 mg ORAL ANDA 27 sections