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

Stem definitionDrug idCAS RN
anti-infectives, sulfonamides 2514 723-46-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • sulfamethoxazole
  • sulfamethalazole
  • sulfamethoxazol
  • sulfisomezole
  • sulphamethoxazole
A bacteriostatic antibacterial agent that interferes with folic acid synthesis in susceptible bacteria. Its broad spectrum of activity has been limited by the development of resistance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p208)
  • Molecular weight: 253.28
  • Formula: C10H11N3O3S
  • CLOGP: 0.56
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 98.22
  • ALOGS: -2.74
  • ROTB: 2
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
2 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.50 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 14 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 394.82 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.36 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.23 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 9.80 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -0.764 High 0.80
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.002 High 0.80
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 26.122 10^-6 cm/s High 0.80
dh-clint Dog hepatocyte intrinsic clearance 1.528 uL/min/10^6 cells High 0.80
dppb Dog plasma protein binding (% unbound) 42.120 % High 0.80
fcs-ppb Fetal calf serum protein binding (% unbound) 55.670 % High 0.80
herg hERG pIC50 3.795 pIC50 High 0.80
hh-clint Human hepatocyte intrinsic clearance 1.321 uL/min/10^6 cells High 0.80
hlm-clint Human liver microsomal intrinsic clearance 3.289 uL/min/mg protein High 0.80
hppb Human plasma protein binding (% unbound) 34.160 % High 0.80
kinase-safety-class ACVR2A,ACVR2B,AKT3,ALK,AURKA,AURKB,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GRK3,GSK3B,ITK,JAK1,JAK2,KIT,MAP2K6,MAP3K1,MAP3K21,MAP3K7,MAP4K1,MAPK1,MAPK12,MAPK7,MAPK9,MARK4,MTOR,NTRK2,PAK4,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PIM2,PRKCD,PRKDC,SGK1,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1 58
kinase-selectivity-class ACVR2A,ACVR2B,AURKA,AURKB,AXL,BRAF,CAMK2D,CDK1,CDK9,DDR1,DYRK1B,ERBB2,FLT3,GRK2,JAK1,JAK2,MAP2K3,MAP2K6,MAP3K1,MAP3K21,MAP3K7,MAP4K1,MAPK7,MARK4,NTRK3,PDK4,PRKDC,SGK1,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1,ULK2 36
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 1.945 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.786 High 0.80
mh-clint Mouse hepatocyte intrinsic clearance 1.611 High 0.80
mppb Mouse plasma protein binding (% unbound) 68.030 High 0.80
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.202 High 0.80
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 53.390 % High 0.80
rat-kpuu-brain Rat brain Kpuu 0.224 % High 1
rh-clint Rat hepatocyte intrinsic clearance 0.916 uL/min/10^6 cells High 0.80
rh-fuinc Rat hepatocyte fraction unbound in incubation 94.320 % High 0.80
rppb Rat plasma protein binding (% unbound) 23.940 % High 0.80
solubility-dd Solubility at pH 7.4 in DMSO 972.747 uM High 0.80

Approvals:

DateAgencyCompanyOrphan
July 30, 1973 FDA MONARCH PHARMS

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
Sleep disorder due to general medical condition, insomnia type 1665.60 13.72 1595 168134 127099 90331619
Folliculitis 1342.96 13.72 1779 167950 202574 90256144
Muscle injury 1276.46 13.72 1612 168117 175042 90283676
Irritable bowel syndrome 1223.75 13.72 1714 168015 205734 90252984
Impaired healing 1177.07 13.72 1794 167935 232405 90226313
Ill-defined disorder 1077.34 13.72 1519 168210 183372 90275346
Stomatitis 947.40 13.72 1779 167950 272919 90185799
Gastrointestinal disorder 928.57 13.72 1697 168032 254990 90203728
Lower respiratory tract infection 911.56 13.72 1661 168068 248998 90209720
Blister 881.11 13.72 1653 168076 253345 90205373
Helicobacter infection 844.72 13.72 1519 168210 225331 90233387
Duodenal ulcer perforation 830.65 13.72 1487 168242 219801 90238917
Infection 729.72 13.72 1890 167839 360204 90098514
Sinusitis 702.80 13.72 1802 167927 341286 90117432
Pericarditis 634.71 13.72 1496 168233 268655 90190063
Contusion 628.44 13.72 1426 168303 249790 90208928
Hand deformity 620.59 13.72 1570 168159 294792 90163926
Synovitis 613.16 13.72 1671 168058 328081 90130637
Anti-cyclic citrullinated peptide antibody positive 604.64 13.72 1354 168375 235079 90223639
Wound 572.84 13.72 1545 168184 301435 90157283
Confusional state 563.27 13.72 1795 167934 384410 90074308
Glossodynia 538.72 13.72 1570 168159 320209 90138509
Discomfort 518.51 13.72 1399 168330 272936 90185782
Swelling 503.97 13.72 1826 167903 417232 90041486
Weight increased 481.45 13.72 1796 167933 416131 90042587
Systemic lupus erythematosus 479.08 13.72 1628 168101 360268 90098450
Fall 474.18 13.72 156 169573 481654 89977064
Therapeutic product effect decreased 468.91 13.72 1359 168370 276212 90182506
Pemphigus 464.27 13.72 1506 168223 325358 90133360
Hypersensitivity 422.86 13.72 1828 167901 452849 90005869
Infusion related reaction 419.73 13.72 1717 168012 415063 90043655
Nasopharyngitis 417.78 13.72 1687 168042 405417 90053301
Product dose omission issue 415.87 13.72 35 169694 291652 90167066
Peripheral swelling 409.78 13.72 1694 168035 411412 90047306
Hepatic enzyme increased 408.35 13.72 1542 168187 359194 90099524
Pyrexia 373.82 13.72 2311 167418 658174 89800544
Joint swelling 345.24 13.72 1854 167875 501446 89957272
Toxicity to various agents 341.50 13.72 63 169666 287783 90170935
Arthropathy 327.61 13.72 1456 168273 364786 90093932
Cough 322.04 13.72 144 169585 368818 90089900
Injury 321.24 13.72 954 168775 196395 90262323
Death 306.17 13.72 244 169485 456307 90002411
Rheumatoid arthritis 292.02 13.72 1398 168331 361216 90097502
Pruritus 289.92 13.72 1869 167860 539656 89919062
C-reactive protein abnormal 282.89 13.72 691 169038 126738 90331980
Nausea 282.45 13.72 1099 168630 1109217 89349501
Rheumatic fever 262.32 13.72 754 168975 152367 90306351
Sleep disorder 261.62 13.72 891 168838 197139 90261579
Injection site pain 258.41 13.72 17 169712 173682 90285036
X-ray abnormal 248.99 13.72 363 169366 45061 90413657
Swollen joint count increased 246.78 13.72 603 169126 110603 90348115
Road traffic accident 227.63 13.72 573 169156 107053 90351665
Deep vein thrombosis postoperative 223.01 13.72 442 169287 70367 90388351
Off label use 222.19 13.72 1188 168541 1101064 89357654
Adjustment disorder with depressed mood 220.93 13.72 388 169341 56365 90402353
Completed suicide 219.35 13.72 13 169716 145045 90313673
Liver disorder 204.60 13.72 594 169135 120675 90338043
Blood pressure increased 202.41 13.72 59 169670 197158 90261560
Dislocation of vertebra 201.70 13.72 370 169359 55598 90403120
Constipation 199.16 13.72 141 169588 280254 90178464
Autoimmune disorder 197.41 13.72 441 169288 76303 90382415
Medication error 196.34 13.72 467 169262 84185 90374533
COVID-19 195.82 13.72 39 169690 168804 90289914
Lip dry 190.44 13.72 515 169214 100440 90358278
Diarrhoea 189.17 13.72 1012 168717 938178 89520540
Lower limb fracture 186.47 13.72 459 169270 84554 90374164
Drug ineffective 183.10 13.72 1687 168042 1382611 89076107
Back pain 180.05 13.72 197 169532 316978 90141740
C-reactive protein 176.75 13.72 254 169475 31113 90427605
Abdominal discomfort 175.59 13.72 1508 168221 475820 89982898
Type 2 diabetes mellitus 175.37 13.72 800 168929 202444 90256274
Hypotension 172.97 13.72 213 169516 325184 90133534
Urinary tract infection 168.91 13.72 194 169535 305438 90153280
Dizziness 168.70 13.72 554 169175 588730 89869988
Breast cancer stage II 167.58 13.72 264 169465 35070 90423648
Sciatica 167.55 13.72 493 169236 100889 90357829
Headache 161.46 13.72 952 168777 861794 89596924
Intentional overdose 160.61 13.72 3 169726 93831 90364887
Contraindicated product administered 160.01 13.72 1087 168642 319052 90139666
Drug interaction 153.27 13.72 175 169554 276278 90182440
Rheumatoid factor positive 149.80 13.72 678 169051 170972 90287746
Feeling abnormal 149.35 13.72 63 169666 167172 90291546
Pregnancy 145.70 13.72 344 169385 61703 90397015
Subcutaneous drug absorption impaired 145.56 13.72 152 169577 13393 90445325
Influenza 144.10 13.72 41 169688 139223 90319495
Psoriatic arthropathy 141.95 13.72 820 168909 227515 90231203
Joint range of motion decreased 140.16 13.72 564 169165 135079 90323639
Gait inability 138.03 13.72 592 169137 145864 90312854
Alopecia 137.87 13.72 1475 168254 493596 89965122
Injection site erythema 134.46 13.72 14 169715 98488 90360230
Hyperhidrosis 134.05 13.72 44 169685 136261 90322457
Pneumonia 132.38 13.72 680 169049 637379 89821339
Rash 128.53 13.72 2148 167581 793952 89664766
Inappropriate schedule of product administration 126.81 13.72 61 169668 149872 90308846
Facet joint syndrome 126.57 13.72 439 169290 97950 90360768
Drug abuse 125.64 13.72 7 169722 82340 90376378
Syncope 124.99 13.72 46 169683 132617 90326101
Disease progression 121.74 13.72 71 169658 156544 90302174
Balance disorder 119.98 13.72 19 169710 97061 90361657
Cerebrovascular accident 119.51 13.72 41 169688 123492 90335226
Oropharyngeal pain 117.17 13.72 35 169694 115152 90343566
Rash vesicular 115.43 13.72 156 169573 18041 90440677
General symptom 113.88 13.72 139 169590 14529 90444189
Fibromyalgia 112.44 13.72 716 169013 205553 90253165
Illness 110.98 13.72 12 169717 81957 90376761
Myalgia 110.55 13.72 99 169630 175026 90283692
Suicide attempt 110.29 13.72 8 169721 75391 90383327
Chest discomfort 108.57 13.72 62 169667 138303 90320415
Anaemia 107.62 13.72 322 169407 352480 90106238
Atrial fibrillation 107.54 13.72 58 169671 133553 90325165
Pustular psoriasis 107.09 13.72 152 169577 18404 90440314
Maternal exposure timing unspecified 106.63 13.72 168 169561 22315 90436403
Palpitations 106.24 13.72 62 169667 136666 90322052
Drug intolerance 103.22 13.72 1286 168443 446305 90012413
Rhinorrhoea 103.21 13.72 20 169709 88296 90370422
Acute kidney injury 103.14 13.72 285 169444 320102 90138616
Urticaria 101.48 13.72 962 168767 311772 90146946
Therapy non-responder 100.46 13.72 514 169215 136190 90322528
Stress 100.43 13.72 16 169713 81379 90377339
Loss of consciousness 98.87 13.72 71 169658 140167 90318551
Wrong technique in product usage process 98.13 13.72 10 169719 71561 90387157
Dry skin 96.69 13.72 23 169706 88050 90370668
Erythema 96.57 13.72 176 169553 229070 90229648
Incorrect dose administered 96.30 13.72 16 169713 78914 90379804
Pain in extremity 94.53 13.72 478 169251 450051 90008667
Myocardial infarction 94.47 13.72 40 169689 105932 90352786
Oxygen saturation decreased 93.55 13.72 42 169687 107441 90351277
Night sweats 92.42 13.72 481 169248 128285 90330433
Wound infection 90.33 13.72 417 169312 105985 90352733
Suicidal ideation 90.04 13.72 15 169714 73840 90384878
Somnolence 89.43 13.72 159 169570 208925 90249793
Heart rate increased 89.42 13.72 50 169679 112852 90345866
Cataract 89.33 13.72 14 169715 72078 90386640
Nasal congestion 89.21 13.72 23 169706 83391 90375327
Pre-engraftment immune reaction 89.15 13.72 29 169700 239 90458479
Injection site swelling 88.54 13.72 6 169723 59833 90398885
Neuropathy peripheral 88.16 13.72 76 169653 136894 90321824
Delirium 87.13 13.72 407 169322 103952 90354766
Myositis 86.26 13.72 159 169570 23969 90434749
Tremor 84.79 13.72 97 169632 153076 90305642
Injection site bruising 84.53 13.72 3 169726 52304 90406414
Influenza like illness 82.88 13.72 24 169705 80587 90378131
Malignant neoplasm progression 82.26 13.72 49 169680 106821 90351897
Flushing 81.15 13.72 32 169697 88459 90370259
Dysphagia 80.25 13.72 56 169673 112222 90346496
Amnesia 79.72 13.72 408 169321 108097 90350621
Cardiac failure congestive 79.19 13.72 43 169686 98651 90360067
General physical health deterioration 79.11 13.72 1014 168715 354101 90104617
Grip strength decreased 76.51 13.72 360 169369 92216 90366502
Neck pain 74.86 13.72 62 169667 113901 90344817
Herpes zoster 74.83 13.72 42 169687 94602 90364116
Back disorder 74.73 13.72 155 169574 25476 90433242
Lung disorder 74.20 13.72 508 169221 149375 90309343
Blood glucose increased 72.84 13.72 44 169685 95202 90363516
Porphyria acute 72.68 13.72 125 169604 17850 90440868
Bradycardia 72.60 13.72 33 169696 83814 90374904
Injection site pruritus 72.58 13.72 8 169721 53826 90404892
Breast cancer 72.45 13.72 8 169721 53753 90404965
Abdominal distension 71.97 13.72 83 169646 130518 90328200
Neutropenia 71.64 13.72 201 169528 224703 90234015
Retinitis 71.29 13.72 195 169534 38263 90420455
Dehydration 71.06 13.72 162 169567 194285 90264433
Cognitive disorder 70.74 13.72 21 169708 69386 90389332
Cardiac disorder 70.56 13.72 11 169718 56861 90401857
Dry mouth 70.36 13.72 587 169142 183472 90275246
Prescribed overdose 70.27 13.72 365 169364 97260 90361458
Vision blurred 70.01 13.72 62 169667 110231 90348487
Lupus vulgaris 69.58 13.72 214 169515 44845 90413873
Overdose 69.19 13.72 118 169611 157591 90301127
Throat irritation 68.89 13.72 6 169723 48689 90410029
Chronic obstructive pulmonary disease 68.86 13.72 26 169703 73803 90384915
Hot flush 68.40 13.72 14 169715 59474 90399244
Dysphonia 68.22 13.72 17 169712 63067 90395651
Seizure 68.06 13.72 113 169616 152516 90306202
Chills 67.34 13.72 89 169640 131892 90326826
Pulmonary fibrosis 67.33 13.72 387 169342 107116 90351602
Epistaxis 65.55 13.72 39 169690 85086 90373632
Unevaluable event 64.98 13.72 12 169717 54836 90403882
Hypokalaemia 64.29 13.72 91 169638 131025 90327693
Cardiac failure 63.17 13.72 67 169662 109429 90349289
Blood pressure fluctuation 63.11 13.72 11 169718 52402 90406316
Multiple sclerosis relapse 62.93 13.72 11 169718 52294 90406424
Sedation 62.85 13.72 8 169721 48163 90410555
Hypothyroidism 62.14 13.72 12 169717 53115 90405603
Depressed mood 61.66 13.72 10 169719 50212 90408506
Renal impairment 61.39 13.72 64 169665 105357 90353361
Abdominal pain 61.01 13.72 462 169267 395259 90063459
Walking aid user 59.90 13.72 174 169555 35332 90423386
Femur fracture 59.29 13.72 8 169721 46074 90412644
Vomiting 59.19 13.72 1080 168649 787213 89671505
Liver injury 58.42 13.72 531 169198 170036 90288682
Anaphylactic reaction 58.24 13.72 47 169682 87477 90371241
Adverse event 58.12 13.72 398 169331 117020 90341698
Asthenia 57.93 13.72 680 169049 533071 89925647
Cardio-respiratory arrest 57.62 13.72 23 169706 63117 90395601
Nephrolithiasis 57.59 13.72 11 169718 49074 90409644
Cardiac arrest 57.47 13.72 67 169662 104868 90353850
Surgery 57.26 13.72 8 169721 44879 90413839
Dysgeusia 57.15 13.72 14 169715 52546 90406172
Depressed level of consciousness 56.53 13.72 33 169696 72751 90385967
Drug ineffective for unapproved indication 56.50 13.72 27 169702 66617 90392101
Sepsis 56.30 13.72 162 169567 179652 90279066
Full blood count abnormal 56.17 13.72 3 169726 36594 90422124
Hyponatraemia 55.78 13.72 103 169626 133435 90325283
Device expulsion 55.31 13.72 6 169723 40880 90417838
Inflammation 55.20 13.72 544 169185 178048 90280670
Gastrointestinal haemorrhage 54.59 13.72 53 169676 90195 90368523
Peripheral venous disease 54.45 13.72 305 169424 83616 90375102
No adverse event 53.98 13.72 30 169699 67952 90390766
Vertigo 53.73 13.72 32 169697 69779 90388939
Electrocardiogram QT prolonged 53.30 13.72 35 169694 72421 90386297
Haematochezia 52.51 13.72 34 169695 70879 90387839
Sinus disorder 52.32 13.72 3 169726 34444 90424274
Wheezing 51.77 13.72 677 169052 237403 90221315
Oedema 51.55 13.72 588 169141 199707 90259011
Blood pressure decreased 51.38 13.72 39 169690 74856 90383862
Limb discomfort 50.44 13.72 6 169723 38054 90420664
Burning sensation 50.38 13.72 28 169701 63424 90395294
Serotonin syndrome 50.15 13.72 6 169723 37881 90420837
Therapy cessation 50.05 13.72 5 169724 36356 90422362
Pain in jaw 49.85 13.72 14 169715 47971 90410747
Hypoglycaemia 49.69 13.72 35 169694 69813 90388905
Skin exfoliation 49.69 13.72 33 169696 67880 90390838
Heart rate decreased 49.63 13.72 19 169710 53486 90405232
Haemoglobin decreased 49.19 13.72 148 169581 161808 90296910
Intestinal obstruction 48.85 13.72 6 169723 37125 90421593
Encephalitis viral 48.76 13.72 35 169694 1854 90456864
Deafness transitory 48.53 13.72 36 169693 2007 90456711
Disturbance in attention 48.47 13.72 14 169715 47095 90411623
Bursitis 48.25 13.72 416 169313 131238 90327480
Anti-cyclic citrullinated peptide antibody 47.47 13.72 135 169594 27086 90431632
Arrhythmia 46.57 13.72 11 169718 42321 90416397
Productive cough 45.76 13.72 46 169683 77017 90381701
Angina pectoris 45.47 13.72 9 169720 39151 90419567
Eczema 45.47 13.72 21 169708 52849 90405869
Dyspnoea exertional 45.43 13.72 41 169688 72247 90386471
Dry eye 45.37 13.72 26 169703 57905 90400813
Haemorrhage 45.23 13.72 38 169691 69331 90389387
Dysarthria 44.79 13.72 23 169706 54459 90404259
Product prescribing error 44.66 13.72 3 169726 30142 90428576
Cystitis 44.18 13.72 36 169693 66682 90392036
Bone pain 44.17 13.72 31 169698 61952 90396766
Cellulitis 44.17 13.72 64 169665 91273 90367445
Disability 44.12 13.72 172 169557 40573 90418145
Lupus-like syndrome 43.35 13.72 194 169535 48652 90410066
Prescribed underdose 43.07 13.72 264 169465 74755 90383963
Angioedema 42.96 13.72 35 169694 64841 90393877
Exostosis 42.71 13.72 205 169524 52929 90405789
Musculoskeletal pain 42.39 13.72 499 169230 170752 90287966
Acne 41.76 13.72 3 169726 28504 90430214
Bone erosion 41.49 13.72 203 169526 52818 90405900
Osteonecrosis of jaw 41.39 13.72 11 169718 39092 90419626
Hypoxia 40.98 13.72 45 169684 72354 90386364
Respiratory failure 40.59 13.72 102 169627 118316 90340402
Blood cholesterol increased 40.51 13.72 580 169149 207432 90251286
Drug dependence 40.45 13.72 4 169725 29323 90429395
Intentional product misuse 40.25 13.72 66 169663 89538 90369180
Aphasia 40.05 13.72 15 169714 42797 90415921
Swollen tongue 39.92 13.72 18 169711 45938 90412780
Hallucination 39.59 13.72 39 169690 65920 90392798
Malaise 39.58 13.72 817 168912 585169 89873549
Pleural effusion 39.54 13.72 95 169634 111896 90346822
Flatulence 39.53 13.72 14 169715 41353 90417365
Anaphylactic shock 39.48 13.72 6 169723 31611 90427107
Blood calcium decreased 39.41 13.72 5 169724 30177 90428541
Pulmonary embolism 39.39 13.72 120 169609 130700 90328018
Hip arthroplasty 39.31 13.72 261 169468 75947 90382771
Device dislocation 39.26 13.72 6 169723 31476 90427242
Oral pain 39.04 13.72 7 169722 32676 90426042
Diverticulitis 38.78 13.72 18 169711 45169 90413549
Foetal exposure during pregnancy 38.65 13.72 16 169713 42959 90415759
Orthostatic hypotension 38.55 13.72 15 169714 41812 90416906
Human herpesvirus 6 infection 37.75 13.72 39 169690 3393 90455325
Neoplasm progression 37.75 13.72 18 169711 44468 90414250
Tinnitus 37.25 13.72 17 169712 43085 90415633
Swelling face 36.47 13.72 60 169669 81292 90377426
Tooth disorder 36.40 13.72 7 169722 31083 90427635
Localised infection 36.37 13.72 9 169720 33553 90425165
Speech disorder 36.36 13.72 20 169709 45565 90413153
Maternal exposure during pregnancy 36.05 13.72 906 168823 359157 90099561
Abortion spontaneous 36.00 13.72 29 169700 54027 90404691
Hip fracture 35.59 13.72 9 169720 33068 90425650
Alanine aminotransferase abnormal 35.15 13.72 47 169682 5379 90453339
Poor quality sleep 35.05 13.72 3 169726 24690 90434028
Limb injury 35.03 13.72 8 169721 31500 90427218
Lethargy 34.91 13.72 40 169689 63099 90395619
Pulmonary hypertension 34.88 13.72 18 169711 42505 90416213
Metastases to liver 34.78 13.72 6 169723 28801 90429917
Rhabdomyolysis 34.76 13.72 27 169702 51229 90407489
Diabetic ketoacidosis 34.54 13.72 3 169726 24404 90434314
Obstructive airways disorder 34.48 13.72 4 169725 25865 90432853
Intervertebral disc protrusion 34.33 13.72 5 169724 27191 90431527
Skin disorder 34.10 13.72 13 169716 36693 90422025
Lactic acidosis 33.69 13.72 27 169702 50436 90408282
Insomnia 33.35 13.72 839 168890 332635 90126083
Bronchitis 33.29 13.72 160 169569 152767 90305951
Product administration error 33.03 13.72 5 169724 26418 90432300
Melaena 32.87 13.72 12 169717 34785 90423933
Underdose 32.86 13.72 193 169536 53824 90404894
Drug hypersensitivity 32.83 13.72 1117 168612 462492 89996226
Psychotic disorder 32.65 13.72 9 169720 31221 90427497
Diabetes mellitus 31.82 13.72 45 169684 64830 90393888
Live birth 31.66 13.72 255 169474 78852 90379866
Immunodeficiency 31.64 13.72 21 169708 43213 90415505
Metastases to bone 31.49 13.72 5 169724 25500 90433218
Gastroenteritis viral 31.27 13.72 9 169720 30346 90428372
Withdrawal syndrome 31.26 13.72 3 169726 22521 90436197
Red blood cell sedimentation rate 31.18 13.72 41 169688 4617 90454101
Lip swelling 30.71 13.72 17 169712 38593 90420125
Ischaemic stroke 30.64 13.72 3 169726 22163 90436555
Drug withdrawal syndrome 30.55 13.72 8 169721 28715 90430003
Therapy partial responder 30.42 13.72 3 169726 22040 90436678
Hypercholesterolaemia 30.03 13.72 305 169424 100587 90358131
Arthralgia 29.97 13.72 1762 167967 776760 89681958
Acute myocardial infarction 29.78 13.72 14 169715 34876 90423842
Renal disorder 29.63 13.72 17 169712 37842 90420876
Haematemesis 29.62 13.72 13 169716 33713 90425005
Agitation 29.60 13.72 50 169679 67048 90391670
Seasonal allergy 29.54 13.72 4 169725 22979 90435739
Hypersomnia 29.53 13.72 3 169726 21528 90437190
Blood pressure diastolic decreased 29.45 13.72 7 169722 26819 90431899
Frequent bowel movements 29.36 13.72 195 169534 56740 90401978
Red blood cell sedimentation rate abnormal 29.31 13.72 5 169724 24199 90434519
Skin haemorrhage 29.27 13.72 3 169726 21377 90437341
Skin discolouration 29.23 13.72 24 169705 44291 90414427
Urinary incontinence 29.22 13.72 17 169712 37549 90421169
Vaginal haemorrhage 29.18 13.72 11 169718 31260 90427458
Pneumonitis 29.03 13.72 24 169705 44146 90414572
Blindness 29.03 13.72 7 169722 26561 90432157
Transient ischaemic attack 28.95 13.72 23 169706 43153 90415565
Pulmonary mass 28.78 13.72 9 169720 28763 90429955
Laryngitis 28.74 13.72 178 169551 50575 90408143
Red blood cell sedimentation rate increased 28.70 13.72 258 169471 82337 90376381
Blood test abnormal 28.53 13.72 3 169726 20949 90437769
Hemiparesis 28.37 13.72 12 169717 31807 90426911
Hepatic steatosis 28.34 13.72 17 169712 36928 90421790
Sleep apnoea syndrome 28.26 13.72 12 169717 31735 90426983
Urinary retention 28.07 13.72 18 169711 37726 90420992
Restlessness 28.02 13.72 16 169713 35704 90423014
Disease recurrence 27.95 13.72 18 169711 37635 90421083
Drug resistance 27.93 13.72 11 169718 30438 90428280
Hypomagnesaemia 27.83 13.72 16 169713 35572 90423146
Dyskinesia 27.76 13.72 17 169712 36517 90422201
Therapeutic response unexpected 27.67 13.72 4 169725 21876 90436842
Haemoptysis 27.49 13.72 14 169715 33306 90425412
Movement disorder 27.43 13.72 10 169719 29009 90429709
Acute respiratory failure 27.38 13.72 24 169705 42894 90415824
Upper gastrointestinal haemorrhage 27.27 13.72 5 169724 22971 90435747
Unresponsive to stimuli 27.25 13.72 19 169710 38102 90420616
Cerebral infarction 27.18 13.72 8 169721 26588 90432130
Nervousness 27.08 13.72 15 169714 34041 90424677
Blood creatine phosphokinase increased 27.03 13.72 15 169714 34008 90424710
Dyspnoea 26.90 13.72 1955 167774 879000 89579718
Respiratory tract congestion 26.67 13.72 9 169720 27401 90431317
Hypocalcaemia 26.66 13.72 24 169705 42344 90416374
Viral infection 26.61 13.72 23 169706 41391 90417327
Dysstasia 26.61 13.72 7 169722 25045 90433673
Pulmonary arterial hypertension 26.54 13.72 8 169721 26179 90432539
Irritability 26.53 13.72 17 169712 35645 90423073
Dysuria 26.41 13.72 21 169708 39380 90419338
Mucosal inflammation 26.30 13.72 42 169687 57583 90401135
Bronchiectasis 26.20 13.72 5 169724 22325 90436393
Thrombosis 25.96 13.72 62 169667 73189 90385529
Haematoma 25.94 13.72 21 169708 39027 90419691
Abdominal pain lower 25.93 13.72 12 169717 30165 90428553
Head injury 25.88 13.72 13 169716 31175 90427543
Fungal infection 25.86 13.72 25 169704 42636 90416082
Pulmonary oedema 25.81 13.72 48 169681 62032 90396686
Fracture 25.79 13.72 5 169724 22071 90436647
Febrile neutropenia 25.74 13.72 182 169547 158167 90300551
Cardiogenic shock 25.68 13.72 7 169722 24461 90434257
Loss of personal independence in daily activities 25.40 13.72 150 169579 135955 90322763
Rib fracture 25.17 13.72 9 169720 26426 90432292
Throat tightness 24.91 13.72 12 169717 29472 90429246
Eye swelling 24.76 13.72 12 169717 29374 90429344
Ear pain 24.74 13.72 189 169540 57513 90401205
Mouth ulceration 24.73 13.72 23 169706 39951 90418767
Clostridium difficile infection 24.69 13.72 19 169710 36226 90422492
Skin laceration 24.56 13.72 9 169720 26026 90432692
Faeces discoloured 24.54 13.72 5 169724 21315 90437403
Myelosuppression 24.51 13.72 39 169690 53552 90405166
Restless legs syndrome 24.40 13.72 6 169723 22464 90436254
Palmar-plantar erythrodysaesthesia syndrome 24.30 13.72 11 169718 28012 90430706
Functional gastrointestinal disorder 24.24 13.72 38 169691 5024 90453694
Hypoacusis 24.04 13.72 11 169718 27839 90430879
Toothache 24.01 13.72 6 169723 22224 90436494
Musculoskeletal discomfort 24.01 13.72 5 169724 20986 90437732
Presyncope 23.89 13.72 15 169714 31790 90426928
Poor venous access 23.72 13.72 4 169725 19523 90439195
Skin fissures 23.71 13.72 5 169724 20804 90437914
Sensory loss 23.58 13.72 3 169726 18072 90440646
Gastritis 23.57 13.72 26 169703 41727 90416991
Affect lability 23.56 13.72 3 169726 18060 90440658
White blood cell count decreased 23.45 13.72 200 169529 166909 90291809
Hepatitis 23.42 13.72 62 169667 70677 90388041
Respiratory tract infection 23.41 13.72 47 169682 59031 90399687
Panic attack 23.41 13.72 10 169719 26355 90432363
Colitis 23.38 13.72 61 169668 69881 90388837
Osteopenia 23.36 13.72 7 169722 22995 90435723
Disorientation 23.27 13.72 29 169700 44085 90414633
Nightmare 23.21 13.72 6 169723 21719 90436999
Lymphadenopathy 23.20 13.72 31 169698 45744 90412974
Rash erythematous 23.16 13.72 55 169674 65049 90393669
Premature baby 23.10 13.72 9 169720 25068 90433650
Hypertensive crisis 23.09 13.72 3 169726 17781 90440937
Product quality issue 23.00 13.72 74 169655 79251 90379467
Tooth infection 22.67 13.72 5 169724 20165 90438553
Device difficult to use 22.65 13.72 3 169726 17522 90441196
Iron deficiency anaemia 22.62 13.72 8 169721 23654 90435064
Coordination abnormal 22.62 13.72 6 169723 21350 90437368
Blood potassium decreased 22.53 13.72 34 169695 47693 90411025
Multiple sclerosis 22.52 13.72 12 169717 27828 90430890
Crying 22.34 13.72 10 169719 25635 90433083
Aggression 22.31 13.72 11 169718 26657 90432061
Full blood count decreased 22.30 13.72 14 169715 29675 90429043
Mobility decreased 22.21 13.72 621 169108 250113 90208605
Altered state of consciousness 22.17 13.72 16 169713 31516 90427202
Sinus congestion 21.92 13.72 12 169717 27412 90431306
Heart rate irregular 21.88 13.72 9 169720 24259 90434459
Spinal fracture 21.82 13.72 7 169722 22009 90436709
Coeliac disease 21.82 13.72 31 169698 44579 90414139
Blood pressure abnormal 21.82 13.72 5 169724 19640 90439078
Knee arthroplasty 21.74 13.72 245 169484 82937 90375781
Generalised tonic-clonic seizure 21.69 13.72 20 169709 34883 90423835
Obesity 21.66 13.72 297 169432 105210 90353508
Kidney infection 21.21 13.72 11 169718 25905 90432813
Body temperature decreased 21.20 13.72 9 169720 23807 90434911
Oral herpes 21.08 13.72 19 169710 33505 90425213
Encephalopathy 21.05 13.72 34 169695 46410 90412308
Metabolic acidosis 20.64 13.72 46 169683 55630 90403088
Visual acuity reduced 20.60 13.72 9 169720 23401 90435317
Meningoencephalitis herpetic 20.58 13.72 19 169710 1440 90457278
Tenosynovitis 20.49 13.72 67 169662 14500 90444218
Vitamin D deficiency 20.46 13.72 4 169725 17552 90441166
Spinal stenosis 20.24 13.72 4 169725 17420 90441298
Pain of skin 20.20 13.72 3 169726 16079 90442639
Arthritis 20.15 13.72 208 169521 167107 90291611
Infusion site pain 20.06 13.72 6 169723 19732 90438986
Coronary artery disease 20.04 13.72 20 169709 33603 90425115
Aphthous ulcer 20.01 13.72 4 169725 17283 90441435
Secretion discharge 19.89 13.72 3 169726 15893 90442825
Carpal tunnel syndrome 19.82 13.72 10 169719 23918 90434800
Respiratory disorder 19.80 13.72 197 169532 64619 90394099
Mood altered 19.78 13.72 4 169725 17140 90441578
Ascites 19.77 13.72 37 169692 47703 90411015
Respiratory arrest 19.64 13.72 20 169709 33291 90425427
Neuralgia 19.63 13.72 18 169711 31482 90427236
Upper limb fracture 19.46 13.72 8 169721 21570 90437148
Glycosylated haemoglobin increased 19.33 13.72 3 169726 15559 90443159
Exposure during pregnancy 19.29 13.72 322 169407 238088 90220630
Ankle fracture 19.28 13.72 7 169722 20363 90438355
Motor dysfunction 19.26 13.72 6 169723 19224 90439494
Gastric ulcer 19.20 13.72 14 169715 27434 90431284
Retching 19.15 13.72 6 169723 19153 90439565
Blood iron decreased 19.11 13.72 5 169724 17954 90440764
Blood glucose decreased 19.09 13.72 10 169719 23419 90435299
Incorrect route of product administration 19.08 13.72 161 169568 50465 90408253
Tongue disorder 19.07 13.72 54 169675 10806 90447912
Transaminases increased 19.04 13.72 25 169704 37167 90421551
Septic shock 18.93 13.72 87 169642 84073 90374645
Photosensitivity reaction 18.86 13.72 5 169724 17802 90440916
Muscle twitching 18.75 13.72 11 169718 24191 90434527
Poisoning 18.75 13.72 3 169726 15214 90443504
Fear of injection 18.68 13.72 46 169683 8469 90450249
Kidney transplant rejection 18.62 13.72 33 169696 4824 90453894
Blood pressure diastolic abnormal 18.54 13.72 7 169722 19874 90438844
Circulatory collapse 18.35 13.72 12 169717 24892 90433826
Mood swings 18.15 13.72 8 169721 20694 90438024
Musculoskeletal chest pain 18.11 13.72 11 169718 23739 90434979
Foot fracture 18.06 13.72 14 169715 26592 90432126
Injection site reaction 17.97 13.72 100 169629 91980 90366738
Blood pressure systolic abnormal 17.93 13.72 7 169722 19471 90439247
Metastases to lung 17.90 13.72 4 169725 15987 90442731
Acute hepatic failure 17.85 13.72 10 169719 22551 90436167
Ligament sprain 17.71 13.72 3 169726 14596 90444122
Labelled drug-drug interaction medication error 17.69 13.72 3 169726 14579 90444139
Hiatus hernia 17.66 13.72 13 169716 25348 90433370
Cardiac murmur 17.66 13.72 6 169723 18188 90440530
Posterior reversible encephalopathy syndrome 17.53 13.72 10 169719 22329 90436389
Pallor 17.46 13.72 23 169706 34142 90424576
Gout 17.36 13.72 5 169724 16854 90441864
Shock 17.28 13.72 17 169712 28761 90429957
Eye irritation 17.23 13.72 23 169706 33955 90424763
Mass 17.23 13.72 4 169725 15573 90443145
Respiratory depression 17.22 13.72 4 169725 15571 90443147
Musculoskeletal stiffness 17.22 13.72 699 169030 295833 90162885
Pollakiuria 17.09 13.72 22 169707 32983 90425735
Creatinine renal clearance decreased 17.05 13.72 7 169722 18892 90439826
Breast cancer stage III 17.04 13.72 237 169492 84210 90374508
Hypoaesthesia 16.96 13.72 735 168994 313475 90145243
Dementia 16.91 13.72 12 169717 23849 90434869
Enthesopathy 16.75 13.72 47 169682 9357 90449361
Diabetes mellitus inadequate control 16.73 13.72 7 169722 18677 90440041
Glaucoma 16.71 13.72 9 169720 20746 90437972
Bronchospasm 16.64 13.72 9 169720 20700 90438018
Accidental overdose 16.64 13.72 17 169712 28256 90430462
Haemorrhage intracranial 16.56 13.72 4 169725 15158 90443560
Acute myeloid leukaemia 16.54 13.72 9 169720 20631 90438087
Skin burning sensation 16.54 13.72 8 169721 19603 90439115
Condition aggravated 16.43 13.72 930 168799 594615 89864103
Heavy menstrual bleeding 16.38 13.72 9 169720 20521 90438197
Mydriasis 16.32 13.72 4 169725 15008 90443710
Infusion site erythema 16.17 13.72 3 169726 13667 90445051
Swollen joint count 16.16 13.72 44 169685 8609 90450109
Polyneuropathy 16.14 13.72 8 169721 19333 90439385
Ageusia 16.13 13.72 5 169724 16071 90442647
Diplopia 16.08 13.72 18 169711 28696 90430022
Skin irritation 16.06 13.72 3 169726 13600 90445118
Eye pain 15.96 13.72 37 169692 44131 90414587
Right ventricular failure 15.94 13.72 8 169721 19197 90439521
Erythrosis 15.94 13.72 6 169723 79 90458639
Cerebral haemorrhage 15.90 13.72 25 169704 34497 90424221
Cardiovascular disorder 15.88 13.72 3 169726 13489 90445229
Rash macular 15.87 13.72 20 169709 30260 90428458
Postoperative wound infection 15.77 13.72 3 169726 13423 90445295
Stress cardiomyopathy 15.65 13.72 3 169726 13352 90445366
Therapeutic product effect incomplete 15.64 13.72 262 169467 193634 90265084
Hypokinesia 15.54 13.72 5 169724 15692 90443026
Ventricular tachycardia 15.54 13.72 14 169715 24694 90434024
Eye disorder 15.53 13.72 17 169712 27373 90431345
Spondylitis 15.47 13.72 60 169669 14118 90444600
Status epilepticus 15.46 13.72 8 169721 18866 90439852
Middle insomnia 15.45 13.72 6 169723 16745 90441973
Platelet count increased 15.44 13.72 10 169719 20849 90437869
Hypoaesthesia oral 15.39 13.72 5 169724 15595 90443123
Sneezing 15.37 13.72 20 169709 29849 90428869
Treatment failure 15.32 13.72 706 169023 303222 90155496
Hyperglycaemia 15.16 13.72 47 169682 50923 90407795
Tachycardia 15.14 13.72 206 169523 157467 90301251
Abnormal loss of weight 15.12 13.72 37 169692 6786 90451932
Skin reaction 15.00 13.72 8 169721 18545 90440173
Cold sweat 14.83 13.72 4 169725 14077 90444641
Hypervolaemia 14.83 13.72 24 169705 32733 90425985
Pelvic fracture 14.80 13.72 5 169724 15214 90443504
HIV infection 14.78 13.72 10 169719 481 90458237
Extrapyramidal disorder 14.77 13.72 6 169723 16297 90442421
Device breakage 14.77 13.72 4 169725 14040 90444678
Breast cancer metastatic 14.67 13.72 5 169724 15127 90443591
Bone disorder 14.66 13.72 13 169716 23107 90435611
Small intestinal obstruction 14.63 13.72 11 169718 21223 90437495
Neuroleptic malignant syndrome 14.61 13.72 5 169724 15091 90443627
Oesophagitis 14.60 13.72 7 169722 17242 90441476
Skin lesion 14.57 13.72 30 169699 37335 90421383
Emotional disorder 14.46 13.72 5 169724 14992 90443726
Tooth fracture 14.41 13.72 3 169726 12597 90446121
Gingival bleeding 14.31 13.72 5 169724 14898 90443820
Anger 14.26 13.72 4 169725 13716 90445002
Product administration interrupted 14.24 13.72 3 169726 12489 90446229
Hepatic cirrhosis 14.20 13.72 181 169548 63072 90395646
Trimethylaminuria 14.14 13.72 7 169722 185 90458533
Acquired immunodeficiency syndrome 14.13 13.72 6 169723 110 90458608
Dystonia 13.97 13.72 7 169722 16812 90441906
Product complaint 13.91 13.72 4 169725 13496 90445222
Thyroid disorder 13.90 13.72 8 169721 17777 90440941
Interstitial lung disease 13.83 13.72 85 169644 76320 90382398
Treatment noncompliance 13.81 13.72 50 169679 51677 90407041
Sinus tachycardia 13.76 13.72 20 169709 28493 90430225

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 ineffective 189.33 11.62 190 39968 630007 41951170
Pyrexia 159.09 11.62 762 39396 393280 42187897
Cytomegalovirus infection 98.16 11.62 136 40022 32170 42549007
Lymphocyte count decreased 95.07 11.62 124 40034 27685 42553492
Hyperkalaemia 91.53 11.62 221 39937 80237 42500940
Clear cell renal cell carcinoma 90.87 11.62 37 40121 1244 42579933
Alanine aminotransferase increased 90.25 11.62 233 39925 88173 42493004
Immune reconstitution inflammatory syndrome 89.13 11.62 75 40083 10068 42571109
Aspartate aminotransferase increased 88.90 11.62 213 39945 76950 42504227
Off label use 88.41 11.62 308 39850 638027 41943150
Neutropenia 84.68 11.62 392 39766 199039 42382138
Death 81.27 11.62 205 39953 470980 42110197
Blood creatinine increased 80.32 11.62 257 39901 109746 42471431
Lymphoproliferative disorder 78.30 11.62 45 40113 3262 42577915
Product dose omission issue 76.60 11.62 25 40133 154340 42426837
Stevens-Johnson syndrome 71.35 11.62 96 40062 22082 42559095
Anal inflammation 71.27 11.62 37 40121 2192 42578985
Pancytopenia 70.11 11.62 257 39901 117486 42463691
Total lung capacity abnormal 68.46 11.62 46 40112 4397 42576780
Transplant rejection 63.47 11.62 71 40087 13517 42567660
SARS-CoV-2 test negative 61.19 11.62 31 40127 1744 42579433
Hypogammaglobulinaemia 58.77 11.62 64 40094 11827 42569350
Inappropriate schedule of product administration 58.43 11.62 10 40148 95892 42485285
Kidney transplant rejection 58.01 11.62 55 40103 8628 42572549
Neuritis 56.73 11.62 47 40111 6173 42575004
Pulmonary vasculitis 56.43 11.62 47 40111 6219 42574958
Blood immunoglobulin G decreased 56.15 11.62 32 40126 2282 42578895
Neurological symptom 55.09 11.62 57 40101 9934 42571243
Blood urea increased 54.41 11.62 105 40053 32688 42548489
Proctalgia 53.34 11.62 48 40110 7045 42574132
Tenosynovitis 52.52 11.62 40 40118 4655 42576522
Tongue disorder 51.88 11.62 42 40116 5341 42575836
Granuloma skin 50.95 11.62 24 40134 1151 42580026
Red blood cell sedimentation rate 49.74 11.62 23 40135 1057 42580120
Enthesopathy 49.36 11.62 39 40119 4789 42576388
Eosinophilic granulomatosis with polyangiitis 48.93 11.62 50 40108 8588 42572589
Alanine aminotransferase abnormal 48.55 11.62 39 40119 4905 42576272
Forced expiratory volume decreased 48.46 11.62 47 40111 7583 42573594
Pneumocystis jirovecii pneumonia 44.71 11.62 83 40075 25098 42556079
Platelet count decreased 44.45 11.62 252 39906 138329 42442848
Acute kidney injury 44.12 11.62 534 39624 366803 42214374
Pre-engraftment immune reaction 43.80 11.62 13 40145 164 42581013
Hospitalisation 42.62 11.62 9 40149 74321 42506856
Renal tubular necrosis 42.43 11.62 68 40090 18286 42562891
Panniculitis 42.05 11.62 26 40132 2155 42579022
Pulmonary alveolar haemorrhage 41.48 11.62 60 40098 14756 42566421
Blood parathyroid hormone decreased 40.62 11.62 23 40135 1620 42579557
Haemodialysis 40.22 11.62 49 40109 10211 42570966
Encephalitis viral 39.43 11.62 22 40136 1506 42579671
Blood bilirubin increased 38.66 11.62 107 40051 42145 42539032
Vasculitis 38.28 11.62 65 40093 18329 42562848
Fall 38.01 11.62 105 40053 234415 42346762
Haemoglobin decreased 37.40 11.62 233 39925 132238 42448939
Body temperature increased 37.27 11.62 68 40090 20290 42560887
Blood lactate dehydrogenase increased 36.70 11.62 78 40080 26003 42555174
Sphincter of Oddi dysfunction 36.24 11.62 12 40146 221 42580956
White blood cell count decreased 36.21 11.62 202 39956 110194 42470983
Cellulitis enterococcal 35.53 11.62 10 40148 103 42581074
Toxicity to various agents 35.36 11.62 105 40053 229031 42352146
Tendonitis 35.18 11.62 45 40113 9849 42571328
Leukopenia 34.68 11.62 151 40007 74595 42506582
Intentional product misuse 34.46 11.62 8 40150 61892 42519285
Antineutrophil cytoplasmic antibody positive 33.73 11.62 30 40128 4335 42576842
Foetal exposure during pregnancy 33.50 11.62 3 40155 47308 42533869
Cytomegalovirus viraemia 33.49 11.62 45 40113 10332 42570845
Delayed graft function 32.94 11.62 24 40134 2611 42578566
Aplasia pure red cell 32.70 11.62 37 40121 7129 42574048
Respiratory symptom 32.59 11.62 46 40112 11060 42570117
Agranulocytosis 32.56 11.62 82 40076 30530 42550647
Incision site pain 32.47 11.62 21 40137 1882 42579295
Hepatitis 32.09 11.62 76 40082 27224 42553953
Cholestasis 31.81 11.62 85 40073 32794 42548383
Injection site pain 31.14 11.62 8 40150 57790 42523387
Lung disorder 30.52 11.62 107 40051 47816 42533361
Accident 30.40 11.62 34 40124 6469 42574708
Plasma cell myeloma 30.10 11.62 106 40052 47472 42533705
Haemorrhoids 29.90 11.62 56 40102 17041 42564136
C-reactive protein abnormal 29.64 11.62 40 40118 9221 42571956
Liver transplant rejection 29.41 11.62 22 40136 2491 42578686
Dialysis 28.52 11.62 45 40113 11941 42569236
Fatigue 28.47 11.62 268 39890 435373 42145804
Thrombocytopenia 28.42 11.62 289 39869 189990 42391187
Rheumatoid nodule 28.08 11.62 23 40135 2972 42578205
Intentional overdose 27.96 11.62 7 40151 51449 42529728
Pulmonary fibrosis 27.88 11.62 71 40087 26610 42554567
Kaposi's sarcoma 27.74 11.62 14 40144 781 42580396
Blood antidiuretic hormone increased 27.65 11.62 7 40151 46 42581131
Hepatic cytolysis 27.60 11.62 71 40087 26773 42554404
Red blood cells urine positive 27.58 11.62 19 40139 1891 42579286
Gamma-glutamyltransferase increased 27.48 11.62 80 40078 32417 42548760
Weight increased 27.37 11.62 37 40121 107946 42473231
Renal failure 27.36 11.62 230 39928 143496 42437681
Human herpesvirus 6 infection 27.12 11.62 21 40137 2504 42578673
Rectal abscess 27.01 11.62 18 40140 1697 42579480
Chills 26.87 11.62 166 39992 93900 42487277
HIV infection 26.86 11.62 17 40141 1468 42579709
Rash maculo-papular 26.76 11.62 87 40071 37416 42543761
SARS-CoV-2 antibody test positive 26.38 11.62 11 40147 393 42580784
Cerebrovascular accident 25.95 11.62 32 40126 97128 42484049
Arthralgia 25.60 11.62 103 40055 205135 42376042
C-reactive protein increased 25.46 11.62 123 40035 63437 42517740
Toxic skin eruption 25.31 11.62 46 40112 13684 42567493
Blood alkaline phosphatase increased 24.93 11.62 79 40079 33518 42547659
Neutrophil count decreased 24.89 11.62 122 40036 63293 42517884
Somnolence 24.49 11.62 61 40097 141044 42440133
Osteoporotic fracture 24.14 11.62 16 40142 1495 42579682
Acquired immunodeficiency syndrome 23.96 11.62 11 40147 497 42580680
Lymphocele 23.79 11.62 16 40142 1531 42579646
Mycotic allergy 23.60 11.62 26 40132 4865 42576312
Rash 23.57 11.62 379 39779 276575 42304602
Blood immunoglobulin A decreased 23.49 11.62 12 40146 687 42580490
Intentional product use issue 23.33 11.62 20 40138 71813 42509364
Mite allergy 22.94 11.62 26 40132 5020 42576157
Proteus infection 22.89 11.62 15 40143 1375 42579802
Drug reaction with eosinophilia and systemic symptoms 22.65 11.62 89 40069 41986 42539191
Spirometry abnormal 22.52 11.62 26 40132 5120 42576057
Dermatitis exfoliative 22.23 11.62 30 40128 6917 42574260
Graft versus host disease 22.19 11.62 42 40116 12883 42568294
Hypercalcaemia 22.02 11.62 51 40107 18007 42563170
Dust allergy 21.77 11.62 26 40132 5306 42575871
Normochromic normocytic anaemia 21.62 11.62 34 40124 8997 42572180
Skin necrosis 21.33 11.62 28 40130 6286 42574891
Febrile bone marrow aplasia 21.21 11.62 36 40122 10145 42571032
Haemoptysis 21.20 11.62 93 40065 46074 42535103
Parvovirus infection 21.18 11.62 10 40148 482 42580695
Hepatomegaly 21.11 11.62 39 40119 11746 42569431
Dizziness 21.01 11.62 143 40015 249111 42332066
Hepatitis cholestatic 20.82 11.62 35 40123 9789 42571388
Product use issue 20.79 11.62 25 40133 76726 42504451
Aspergillus infection 20.72 11.62 46 40112 15791 42565386
Serum sickness 20.68 11.62 17 40141 2208 42578969
Chronic lymphocytic leukaemia 20.47 11.62 24 40134 4805 42576372
Biopsy liver abnormal 20.41 11.62 7 40151 144 42581033
Bone marrow failure 20.30 11.62 73 40085 33020 42548157
Culture urine positive 20.26 11.62 14 40144 1401 42579776
Complications of transplanted kidney 20.08 11.62 25 40133 5325 42575852
Pneumonia cytomegaloviral 20.02 11.62 22 40136 4104 42577073
Product use in unapproved indication 19.72 11.62 98 40060 184358 42396819
Rash pruritic 19.67 11.62 73 40085 33530 42547647
Conjunctivitis allergic 19.64 11.62 26 40132 5885 42575292
Hepatosplenomegaly 19.48 11.62 23 40135 4637 42576540
Wrong technique in product usage process 19.27 11.62 8 40150 42627 42538550
Cytomegalovirus test positive 19.20 11.62 22 40136 4297 42576880
Pneumocystis jirovecii infection 18.88 11.62 18 40140 2842 42578335
Febrile neutropenia 18.84 11.62 262 39896 185441 42395736
Lung infiltration 18.72 11.62 41 40117 13948 42567229
Vena cava injury 17.97 11.62 8 40150 336 42580841
COVID-19 17.95 11.62 53 40105 115895 42465282
Renal cell carcinoma 17.92 11.62 24 40134 5493 42575684
Psoriasis 17.74 11.62 12 40146 48592 42532585
Blood pressure increased 17.73 11.62 44 40114 101884 42479293
Suicide attempt 17.34 11.62 11 40147 46089 42535088
Obstructive airways disorder 17.27 11.62 57 40101 24702 42556475
Protein urine present 16.98 11.62 24 40134 5777 42575400
Renal tubular disorder 16.94 11.62 22 40136 4887 42576290
Mental status changes 16.50 11.62 81 40077 42034 42539143
Syncope 16.45 11.62 44 40114 99362 42481815
Blood culture positive 16.44 11.62 22 40136 5031 42576146
Hypoxia 16.21 11.62 117 40041 69669 42511508
Culture stool positive 16.17 11.62 7 40151 275 42580902
Erythema infectiosum 16.08 11.62 6 40152 159 42581018
Blood potassium increased 16.02 11.62 46 40112 18490 42562687
Stress 16.02 11.62 11 40147 44201 42536976
Drug eruption 15.98 11.62 53 40105 23022 42558155
Epstein-Barr virus infection 15.97 11.62 31 40127 9687 42571490
Synovitis 15.82 11.62 41 40117 15526 42565651
HIV wasting syndrome 15.81 11.62 5 40153 79 42581098
Human herpesvirus 6 infection reactivation 15.64 11.62 8 40150 459 42580718
Chronic obstructive pulmonary disease 15.61 11.62 22 40136 63092 42518085
Loss of personal independence in daily activities 15.55 11.62 90 40068 49726 42531451
Cystitis haemorrhagic 15.38 11.62 26 40132 7303 42573874
Orbital haemorrhage 15.23 11.62 4 40154 31 42581146
Blood albumin decreased 15.08 11.62 40 40118 15362 42565815
Clonal haematopoiesis 14.98 11.62 6 40152 193 42580984
Leukaemia recurrent 14.71 11.62 13 40145 1863 42579314
Capillaritis 14.67 11.62 14 40144 2214 42578963
Hepatitis A antibody positive 14.60 11.62 4 40154 37 42581140
Oesophageal candidiasis 14.59 11.62 22 40136 5613 42575564
Phlebitis 14.56 11.62 19 40139 4239 42576938
Contusion 14.49 11.62 11 40147 41974 42539203
Enterovirus infection 14.43 11.62 11 40147 1282 42579895
Respiratory failure 14.32 11.62 184 39974 127948 42453229
Wound evisceration 14.27 11.62 5 40153 110 42581067
Liver transplant 14.20 11.62 15 40143 2676 42578501
Rectal prolapse 14.17 11.62 8 40150 560 42580617
Light chain analysis decreased 14.14 11.62 4 40154 42 42581135
Thrombotic microangiopathy 14.08 11.62 38 40120 14744 42566433
Arteriosclerosis 13.99 11.62 43 40115 17946 42563231
Hypertriglyceridaemia 13.92 11.62 30 40128 10096 42571081
Drug interaction 13.87 11.62 173 39985 266826 42314351
Haematochezia 13.83 11.62 21 40137 58415 42522762
Bronchopulmonary aspergillosis 13.79 11.62 45 40113 19384 42561793
Hepatic steatosis 13.74 11.62 48 40110 21400 42559777
Cytomegalovirus test 13.74 11.62 4 40154 47 42581130
Lymphadenopathy 13.67 11.62 65 40093 33300 42547877
Hepatitis B antibody positive 13.51 11.62 4 40154 50 42581127
Peripheral swelling 13.44 11.62 42 40116 90228 42490949
Rash morbilliform 13.39 11.62 18 40140 4135 42577042
Cytomegalovirus chorioretinitis 13.38 11.62 19 40139 4592 42576585
Traumatic liver injury 13.37 11.62 6 40152 257 42580920
Product prescribing error 13.34 11.62 4 40154 26108 42555069
Nasopharyngitis 13.28 11.62 38 40120 83958 42497219
Feeling abnormal 13.03 11.62 29 40129 69757 42511420
Drug hypersensitivity 12.97 11.62 147 40011 99242 42481935
Pneumonia pneumococcal 12.94 11.62 14 40144 2567 42578610
Joint swelling 12.92 11.62 28 40130 67994 42513183
Haematocrit decreased 12.87 11.62 66 40092 34842 42546335
Hepatitis C virus test 12.84 11.62 4 40154 60 42581117
Refusal of treatment by patient 12.77 11.62 20 40138 5271 42575906
Mycobacterium avium complex infection 12.75 11.62 15 40143 3012 42578165
Lymphopenia 12.75 11.62 47 40111 21516 42559661
Renal cyst haemorrhage 12.73 11.62 8 40150 682 42580495
Nodule 12.73 11.62 33 40125 12501 42568676
Lymphocytic infiltration 12.70 11.62 9 40149 937 42580240
CD4 lymphocytes increased 12.57 11.62 5 40153 158 42581019
Stent removal 12.54 11.62 3 40155 15 42581162
Cystic lymphangioma 12.54 11.62 3 40155 15 42581162
Granulomatous rosacea 12.51 11.62 5 40153 160 42581017
Intraductal papillary mucinous neoplasm 12.48 11.62 7 40151 484 42580693
Jaundice 12.48 11.62 65 40093 34524 42546653
Illness 12.41 11.62 4 40154 24926 42556251
Squamous cell carcinoma of skin 12.41 11.62 33 40125 12693 42568484
Therapeutic product effect prolonged 12.28 11.62 6 40152 312 42580865
Complications of transplant surgery 12.16 11.62 7 40151 509 42580668
Abdominal wall haemorrhage 12.13 11.62 7 40151 511 42580666
Meningoencephalitis herpetic 11.99 11.62 9 40149 1025 42580152
Hypoproteinaemia 11.96 11.62 14 40144 2798 42578379
Malignant neoplasm progression 11.92 11.62 57 40101 108343 42472834
Hypoalbuminaemia 11.85 11.62 37 40121 15573 42565604
Perinephric collection 11.78 11.62 5 40153 187 42580990
Glucose urine present 11.73 11.62 10 40148 1365 42579812
Lung neoplasm 11.71 11.62 18 40140 4670 42576507
Septic shock 11.69 11.62 135 40023 91537 42489640
Haemoglobinaemia 11.68 11.62 5 40153 191 42580986

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
Sleep disorder due to general medical condition, insomnia type 1395.88 12.63 1220 170394 104423 110313262
Folliculitis 1206.54 12.63 1392 170222 166261 110251424
Muscle injury 1137.75 12.63 1242 170372 139565 110278120
Irritable bowel syndrome 1119.19 12.63 1326 170288 162889 110254796
Impaired healing 1062.51 12.63 1414 170200 195303 110222382
Ill-defined disorder 942.93 12.63 1189 170425 155664 110262021
Helicobacter infection 874.32 12.63 1236 170378 180641 110237044
Duodenal ulcer perforation 848.83 12.63 1204 170410 176496 110241189
Hand deformity 772.69 12.63 1288 170326 217218 110200467
Glossodynia 754.99 12.63 1286 170328 220718 110196967
Blister 727.34 12.63 1282 170332 226094 110191591
Synovitis 724.93 12.63 1424 170190 272668 110145017
Gastrointestinal disorder 721.40 12.63 1323 170291 240629 110177056
Stomatitis 707.44 12.63 1398 170216 268844 110148841
Wound 693.98 12.63 1278 170336 233159 110184526
Pemphigus 689.10 12.63 1212 170402 213358 110204327
Systemic lupus erythematosus 684.21 12.63 1331 170283 253007 110164678
Lower respiratory tract infection 673.25 12.63 1288 170326 241818 110175867
Pericarditis 666.89 12.63 1209 170405 217905 110199780
Anti-cyclic citrullinated peptide antibody positive 644.89 12.63 1074 170540 180910 110236775
Sinusitis 632.30 12.63 1411 170203 295277 110122408
Infection 621.25 12.63 1583 170031 360617 110057068
Discomfort 578.96 12.63 1125 170489 213582 110204103
Swelling 509.81 12.63 1443 170171 349598 110068087
Contusion 487 12.63 1101 170513 232260 110185425
Infusion related reaction 480.44 12.63 1490 170124 379672 110038013
Therapeutic product effect decreased 472.83 12.63 1119 170495 243197 110174488
Hepatic enzyme increased 464.80 12.63 1318 170296 319574 110098111
Hypersensitivity 450.09 12.63 1514 170100 402484 110015201
Fall 420.11 12.63 206 171408 603276 109814409
Arthropathy 412.43 12.63 1177 170437 286345 110131340
C-reactive protein abnormal 407.48 12.63 726 170888 128969 110288716
Rheumatoid arthritis 403.37 12.63 1199 170415 298414 110119271
Death 378.10 12.63 318 171296 698551 109719134
Toxicity to various agents 369.29 12.63 142 171472 480413 109937272
Product dose omission issue 366.68 12.63 37 171577 321745 110095940
Rheumatic fever 356.94 12.63 664 170950 121915 110295770
Joint swelling 356.88 12.63 1496 170118 441349 109976336
Weight increased 327.49 12.63 1404 170210 418240 109999445
Swollen joint count increased 322.16 12.63 513 171101 83148 110334537
Completed suicide 316.44 12.63 14 171600 242367 110175318
Confusional state 314.14 12.63 1499 170115 467181 109950504
Nasopharyngitis 298.90 12.63 1308 170306 393053 110024632
Injury 294.26 12.63 766 170848 176499 110241186
Contraindicated product administered 289.09 12.63 945 170669 247322 110170363
Pyrexia 285.71 12.63 2372 169242 895893 109521792
Deep vein thrombosis postoperative 281.59 12.63 401 171213 58890 110358795
Peripheral swelling 279.94 12.63 1305 170309 402729 110014956
Road traffic accident 270.18 12.63 547 171067 106851 110310834
Alopecia 265.16 12.63 1195 170419 363558 110054127
X-ray abnormal 261.19 12.63 309 171305 37808 110379877
Autoimmune disorder 256.87 12.63 405 171209 65078 110352607
Lower limb fracture 256.36 12.63 437 171177 74911 110342774
Lip dry 249.68 12.63 508 171106 99575 110318110
Abdominal discomfort 244.63 12.63 1233 170381 392625 110025060
Drug abuse 242.82 12.63 7 171607 177404 110240281
Sciatica 237.65 12.63 475 171139 91924 110325761
Psoriatic arthropathy 237.16 12.63 758 170856 196003 110221682
Liver disorder 234.30 12.63 613 171001 141630 110276055
Cough 232.68 12.63 224 171390 461417 109956268
Rheumatoid factor positive 230.99 12.63 581 171033 131059 110286626
Type 2 diabetes mellitus 222.97 12.63 693 170921 176539 110241146
Off label use 221.17 12.63 1395 170219 1498790 108918895
Adjustment disorder with depressed mood 219.07 12.63 304 171310 43579 110374106
Injection site pain 217.61 12.63 15 171599 177907 110239778
Pregnancy 214.50 12.63 326 171288 50741 110366944
Sleep disorder 208.12 12.63 730 170884 197914 110219771
C-reactive protein 206.35 12.63 245 171369 30086 110387599
Drug interaction 196.48 12.63 295 171319 499888 109917797
Dislocation of vertebra 193.47 12.63 286 171328 43435 110374250
Hypotension 192.50 12.63 323 171291 523526 109894159
Pruritus 188.80 12.63 1544 170070 580016 109837669
Facet joint syndrome 186.49 12.63 443 171171 96385 110321300
Blood pressure increased 182.84 12.63 86 171528 258287 110159398
Drug intolerance 179.48 12.63 1162 170452 405350 110012335
COVID-19 172.74 12.63 82 171532 244978 110172707
Intentional overdose 168.57 12.63 9 171605 132492 110285193
Rash 167.64 12.63 1978 169636 818986 109598699
Constipation 167.30 12.63 185 171429 357601 110060084
Drug ineffective 165.74 12.63 1537 170077 1519003 108898682
Joint range of motion decreased 165.02 12.63 489 171125 121343 110296342
Nausea 163.30 12.63 1186 170428 1234504 109183181
Fibromyalgia 161.97 12.63 608 171006 170301 110247384
Inappropriate schedule of product administration 151.60 12.63 63 171551 203574 110214111
Therapy non-responder 144.42 12.63 554 171060 156753 110260932
Breast cancer stage II 143.20 12.63 194 171420 27181 110390504
Gait inability 140.90 12.63 499 171115 135877 110281808
Urticaria 140.37 12.63 911 170703 317946 110099739
Night sweats 136.50 12.63 488 171126 133495 110284190
Syncope 134.90 12.63 73 171541 202463 110215222
Diarrhoea 133.94 12.63 1129 170485 1138376 109279309
Maternal exposure timing unspecified 133.57 12.63 164 171450 20849 110396836
Dizziness 131.35 12.63 597 171017 697596 109720089
Cerebrovascular accident 130.31 12.63 59 171555 181225 110236460
Pre-engraftment immune reaction 129.95 12.63 42 171572 417 110417268
Maternal exposure during pregnancy 125.14 12.63 749 170865 254134 110163551
Lung disorder 124.76 12.63 582 171032 179465 110238220
Somnolence 124.04 12.63 168 171446 297281 110120404
Back pain 117.49 12.63 250 171364 370746 110046939
Influenza 116.99 12.63 58 171556 169043 110248642
Retinitis 115.92 12.63 192 171422 32135 110385550
Feeling abnormal 113.41 12.63 70 171544 180641 110237044
Lupus vulgaris 111.91 12.63 194 171420 33689 110383996
Prescribed overdose 108.72 12.63 341 171273 87240 110330445
Wrong technique in product usage process 107.85 12.63 7 171607 87341 110330344
Pulmonary fibrosis 107.65 12.63 376 171238 101666 110316019
Atrial fibrillation 107.00 12.63 119 171495 229523 110188162
Suicide attempt 105.35 12.63 17 171597 103377 110314308
Wound infection 103.10 12.63 357 171257 96108 110321577
Rhinorrhoea 102.13 12.63 18 171596 102648 110315037
Stress 101.52 12.63 20 171594 105328 110312357
Inflammation 100.74 12.63 577 171037 192661 110225024
Dry mouth 100.31 12.63 591 171023 199357 110218328
Hyperhidrosis 100.05 12.63 86 171528 187212 110230473
Pneumonia 99.98 12.63 875 170739 875839 109541846
Medication error 99.08 12.63 374 171240 104992 110312693
Oropharyngeal pain 98.83 12.63 43 171571 135233 110282452
Myocardial infarction 98.05 12.63 92 171522 191991 110225694
Urinary tract infection 97.45 12.63 227 171387 326055 110091630
Palpitations 94.04 12.63 66 171548 159146 110258539
Balance disorder 93.52 12.63 32 171582 116528 110301157
Injection site erythema 92.62 12.63 17 171597 94159 110323526
Liver injury 92.54 12.63 470 171144 149943 110267742
Nasal congestion 91.94 12.63 20 171594 98262 110319423
Chronic obstructive pulmonary disease 91.05 12.63 28 171586 109130 110308555
Peripheral venous disease 90.50 12.63 312 171302 83805 110333880
Subcutaneous drug absorption impaired 90.21 12.63 83 171531 7576 110410109
Anaemia 89.49 12.63 491 171123 546595 109871090
Loss of consciousness 87.91 12.63 105 171509 196201 110221484
Encephalitis viral 87.83 12.63 56 171558 2951 110414734
Porphyria acute 87.64 12.63 126 171488 18654 110399031
Bursitis 87.08 12.63 416 171198 129502 110288183
Chest discomfort 86.71 12.63 85 171529 173763 110243922
Incorrect dose administered 85.70 12.63 27 171587 103614 110314071
Illness 82.62 12.63 14 171600 82157 110335528
Cardiac failure 82.28 12.63 102 171512 187524 110230161
Lupus-like syndrome 82.18 12.63 190 171424 40602 110377083
Prescribed underdose 81.10 12.63 254 171360 64920 110352765
Malignant neoplasm progression 80.72 12.63 91 171523 174476 110243209
Suicidal ideation 80.35 12.63 23 171591 93914 110323771
Cardiac arrest 80.11 12.63 113 171501 196640 110221045
Bradycardia 79.94 12.63 74 171540 155443 110262242
Alanine aminotransferase abnormal 79.91 12.63 85 171529 9249 110408436
Sedation 79.33 12.63 8 171606 69675 110348010
Headache 79.30 12.63 932 170682 881445 109536240
Disease progression 79.27 12.63 162 171452 243872 110173813
Cardiac failure congestive 78.63 12.63 71 171543 150929 110266756
Cardio-respiratory arrest 78.21 12.63 41 171573 115795 110301890
Dry skin 75.85 12.63 36 171578 107617 110310068
Adverse event 75.53 12.63 352 171262 108457 110309228
Drug hypersensitivity 75.39 12.63 1054 170560 453036 109964649
Anti-cyclic citrullinated peptide antibody 74.86 12.63 121 171493 19843 110397842
Dysphagia 74.43 12.63 77 171537 153523 110264162
Red blood cell sedimentation rate 74.40 12.63 63 171551 5151 110412534
Overdose 73.59 12.63 158 171456 233636 110184049
Amnesia 73.17 12.63 341 171273 105067 110312618
Gastrointestinal haemorrhage 72.55 12.63 90 171524 165428 110252257
Intentional product misuse 72.22 12.63 60 171554 132844 110284841
Tenosynovitis 71.28 12.63 106 171508 16177 110401508
Musculoskeletal pain 70.96 12.63 507 171107 182516 110235169
Heart rate increased 70.95 12.63 71 171543 143763 110273922
Haematochezia 70.75 12.63 46 171568 115478 110302207
Oxygen saturation decreased 70.24 12.63 84 171530 156898 110260787
Exostosis 69.51 12.63 192 171422 45764 110371921
Serotonin syndrome 69.45 12.63 6 171608 59147 110358538
Tremor 69.36 12.63 130 171484 202102 110215583
Injection site swelling 68.04 12.63 8 171606 61782 110355903
Grip strength decreased 67.60 12.63 275 171339 79899 110337786
Cardiogenic shock 66.82 12.63 6 171608 57332 110360353
Injection site bruising 66.73 12.63 3 171611 51260 110366425
Bone erosion 66.48 12.63 190 171424 46181 110371504
General symptom 66.10 12.63 75 171539 8771 110408914
Wheezing 65.79 12.63 645 170969 254585 110163100
Sepsis 65.00 12.63 274 171340 327072 110090613
Influenza like illness 64.74 12.63 28 171586 88384 110329301
Product prescribing error 63.71 12.63 4 171610 51327 110366358
Epistaxis 63.57 12.63 65 171549 130307 110287378
Hip arthroplasty 63.54 12.63 211 171403 55602 110362083
Accidental exposure to product 61.76 12.63 4 171610 50004 110367681
Cataract 61.75 12.63 23 171591 79462 110338223
Treatment failure 61.25 12.63 679 170935 276555 110141130
Tongue disorder 61.05 12.63 92 171522 14206 110403479
Laryngitis 61.02 12.63 174 171440 42237 110375448
Drug ineffective for unapproved indication 60.24 12.63 43 171571 102795 110314890
Enthesopathy 60.11 12.63 85 171529 12393 110405292
Red blood cell sedimentation rate increased 60.11 12.63 261 171353 78041 110339644
Depressed mood 59.74 12.63 11 171603 60798 110356887
Seizure 59.70 12.63 162 171452 221023 110196662
Myalgia 59.18 12.63 164 171450 222217 110195468
Flushing 58.51 12.63 46 171568 104690 110312995
Depressed level of consciousness 58.20 12.63 53 171561 112225 110305460
Cardiac disorder 57.72 12.63 23 171591 76257 110341428
Neck pain 57.12 12.63 64 171550 123066 110294619
Hot flush 56.79 12.63 16 171598 66020 110351665
Human herpesvirus 6 infection 56.46 12.63 60 171554 6521 110411164
Heart rate decreased 56.30 12.63 29 171585 82727 110334958
Acute kidney injury 56.28 12.63 673 170941 634757 109782928
Cognitive disorder 56.15 12.63 33 171581 87478 110330207
Anaphylactic reaction 55.71 12.63 57 171557 114243 110303442
Haematemesis 55.34 12.63 12 171602 59096 110358589
Live birth 55.18 12.63 234 171380 69250 110348435
Renal impairment 54.72 12.63 133 171481 188312 110229373
Therapy cessation 54.20 12.63 4 171610 44853 110372832
Dyspnoea exertional 54.08 12.63 49 171565 104011 110313674
Rash vesicular 53.84 12.63 88 171526 14564 110403121
Abdominal distension 53.72 12.63 120 171494 174983 110242702
Blood cholesterol increased 53.63 12.63 479 171135 184306 110233379
Acute myocardial infarction 53.18 12.63 32 171582 83745 110333940
Blood pressure fluctuation 52.75 12.63 25 171589 74799 110342886
Dysphonia 52.56 12.63 26 171588 75903 110341782
Electrocardiogram QT prolonged 52.36 12.63 55 171559 108905 110308780
Pustular psoriasis 51.75 12.63 83 171531 13522 110404163
Clear cell renal cell carcinoma 51.48 12.63 39 171575 2717 110414968
Pain in extremity 50.70 12.63 497 171117 486621 109931064
Psychotic disorder 50.50 12.63 9 171605 50928 110366757
Vision blurred 49.68 12.63 77 171537 128945 110288740
Multiple sclerosis relapse 49.55 12.63 9 171605 50231 110367454
Hyponatraemia 49.09 12.63 173 171441 217480 110200205
Blood pressure decreased 48.96 12.63 64 171550 115027 110302658
Injection site pruritus 48.82 12.63 10 171604 51248 110366437
Walking aid user 48.55 12.63 115 171499 24960 110392725
Oedema 48.54 12.63 519 171095 209457 110208228
Ear pain 48.43 12.63 187 171427 53039 110364646
Anal inflammation 48.14 12.63 36 171578 2460 110415225
Unevaluable event 47.96 12.63 16 171598 59211 110358474
Dehydration 47.77 12.63 247 171367 279264 110138421
Mobility decreased 47.72 12.63 571 171043 236851 110180834
Rhabdomyolysis 47.18 12.63 71 171543 120330 110297355
Anaphylactic shock 47.18 12.63 11 171603 51535 110366150
Drug dependence 47.14 12.63 10 171604 50010 110367675
Total lung capacity abnormal 46.99 12.63 46 171568 4537 110413148
Hypoglycaemia 46.93 12.63 67 171547 116037 110301648
Dysarthria 46.92 12.63 37 171577 84084 110333601
Aggression 46.22 12.63 17 171597 59193 110358492
Melaena 45.44 12.63 25 171589 68732 110348953
Breast cancer 45 12.63 4 171610 38538 110379147
Disturbance in attention 44.81 12.63 20 171594 61975 110355710
Osteonecrosis of jaw 44.44 12.63 10 171604 48007 110369678
Lactic acidosis 44.42 12.63 47 171567 92764 110324921
Throat irritation 44.18 12.63 14 171600 53538 110364147
Ischaemic stroke 43.84 12.63 6 171608 41257 110376428
Intentional self-injury 43.39 12.63 4 171610 37425 110380260
Limb discomfort 43.26 12.63 6 171608 40848 110376837
Pain in jaw 42.90 12.63 13 171601 51164 110366521
Kidney transplant rejection 42.71 12.63 71 171543 11916 110405769
Arrhythmia 42.20 12.63 28 171586 69547 110348138
Agitation 42.08 12.63 69 171545 112982 110304703
Lethargy 41.93 12.63 50 171564 93526 110324159
Surgery 41.58 12.63 7 171607 41276 110376409
Herpes zoster 41.42 12.63 65 171549 108314 110309371
Speech disorder 41.25 12.63 22 171592 61547 110356138
Transient ischaemic attack 41.23 12.63 24 171590 63958 110353727
Obesity 41.05 12.63 309 171305 113042 110304643
Nephrolithiasis 41.04 12.63 26 171588 66186 110351499
Diabetic ketoacidosis 40.48 12.63 8 171606 42050 110375635
General physical health deterioration 40.26 12.63 903 170711 424392 109993293
Abdominal pain 39.61 12.63 559 171055 512430 109905255
Vertigo 39.37 12.63 46 171568 86824 110330861
Underdose 39.35 12.63 199 171415 63355 110354330
SARS-CoV-2 test negative 39.19 12.63 30 171584 2123 110415562
Neoplasm progression 39.17 12.63 26 171588 64569 110353116
Dysgeusia 38.76 12.63 31 171583 69954 110347731
Tinnitus 38.60 12.63 23 171591 60517 110357168
Erythema 38.58 12.63 279 171335 291168 110126517
Hypokalaemia 38.53 12.63 149 171465 182299 110235386
Urinary retention 38.42 12.63 31 171583 69652 110348033
Swollen tongue 38.39 12.63 23 171591 60339 110357346
Neuropathy peripheral 38.12 12.63 146 171468 179131 110238554
Angina pectoris 37.87 12.63 25 171589 62270 110355415
Femur fracture 37.82 12.63 11 171603 44458 110373227
Eczema 37.61 12.63 34 171580 72259 110345426
Asthenia 37.37 12.63 800 170814 688199 109729486
Withdrawal syndrome 37.34 12.63 3 171611 31377 110386308
Blood glucose increased 37.30 12.63 95 171519 132401 110285284
Cerebral infarction 37.03 12.63 17 171597 51821 110365864
Eye pruritus 36.70 12.63 4 171610 32771 110384914
Musculoskeletal stiffness 36.22 12.63 623 170991 279199 110138486
Deafness transitory 36.08 12.63 22 171592 1071 110416614
Neuroleptic malignant syndrome 36.07 12.63 5 171609 34054 110383631
Coronary artery disease 35.79 12.63 35 171579 71655 110346030
Intestinal obstruction 35.69 12.63 19 171595 53208 110364477
Burning sensation 35.48 12.63 33 171581 69179 110348506
Haemorrhage 35.33 12.63 70 171544 106622 110311063
Acne 35.31 12.63 5 171609 33515 110384170
Back disorder 35.27 12.63 91 171523 20831 110396854
Pulmonary vasculitis 35.08 12.63 47 171567 6513 110411172
Hallucination 34.94 12.63 65 171549 101367 110316318
Breast cancer stage III 34.71 12.63 226 171388 78891 110338794
Lymphoproliferative disorder 34.52 12.63 49 171565 7169 110410516
Blood parathyroid hormone decreased 34.48 12.63 68 171546 13021 110404664
Unresponsive to stimuli 34.40 12.63 29 171585 63761 110353924
Labelled drug-drug interaction medication error 34.32 12.63 3 171611 29299 110388386
Immune reconstitution inflammatory syndrome 34.26 12.63 77 171537 16149 110401536
Delirium 34.16 12.63 340 171274 134685 110283000
Rheumatoid nodule 33.92 12.63 88 171526 20208 110397477
Altered state of consciousness 33.87 12.63 24 171590 57602 110360083
Cystitis 33.25 12.63 32 171582 66004 110351681
Knee arthroplasty 33.20 12.63 193 171421 64755 110352930
Hypomagnesaemia 33.11 12.63 27 171587 60343 110357342
Cellulitis 32.73 12.63 94 171520 125922 110291763
Limb injury 32.58 12.63 9 171605 37627 110380058
No adverse event 32.50 12.63 40 171574 73799 110343886
Oral pain 32.33 12.63 9 171605 37435 110380250
Restlessness 32.32 12.63 24 171590 56235 110361450
Tooth disorder 32.05 12.63 4 171610 29505 110388180
Fear of injection 32.04 12.63 53 171561 8858 110408827
Sinus disorder 31.98 12.63 6 171608 32722 110384963
Hypoaesthesia 31.89 12.63 674 170940 313549 110104136
Vomiting 31.86 12.63 1125 170489 909550 109508135
Blood creatine phosphokinase increased 31.74 12.63 40 171574 73037 110344648
Neuralgia 31.50 12.63 18 171596 48460 110369225
Poisoning 31.47 12.63 4 171610 29101 110388584
Haematoma 31.03 12.63 27 171587 58449 110359236
Circulatory collapse 30.87 12.63 14 171600 42979 110374706
Panniculitis 30.75 12.63 72 171542 15510 110402175
Neuritis 30.73 12.63 47 171567 7352 110410333
Device dislocation 30.58 12.63 6 171608 31698 110385987
Diverticulitis 30.53 12.63 23 171591 53499 110364186
Iron deficiency anaemia 30.38 12.63 6 171608 31553 110386132
Orthostatic hypotension 30.11 12.63 35 171579 66214 110351471
Therapy partial responder 30.02 12.63 10 171604 37051 110380634
Lip swelling 29.91 12.63 21 171593 50646 110367039
Acute respiratory failure 29.85 12.63 44 171570 75216 110342469
Respiratory arrest 29.64 12.63 28 171586 58271 110359414
Respiratory disorder 29.56 12.63 201 171413 71181 110346504
Lacrimation increased 29.55 12.63 6 171608 30944 110386741
Drug tolerance decreased 29.48 12.63 102 171512 27438 110390247
Device expulsion 29.47 12.63 6 171608 30885 110386800
Lung neoplasm malignant 29.47 12.63 8 171606 33834 110383851
Tendonitis 29.14 12.63 98 171516 25985 110391700
Flatulence 29.00 12.63 23 171591 52126 110365559
Nightmare 28.94 12.63 12 171602 38851 110378834
Myositis 28.86 12.63 110 171504 31006 110386679
Ventricular fibrillation 28.82 12.63 14 171600 41299 110376386
Encephalopathy 28.76 12.63 51 171563 81004 110336681
Pleural effusion 28.71 12.63 160 171454 177549 110240136
Cytomegalovirus infection 28.62 12.63 163 171451 54281 110363404
Blood pressure diastolic decreased 28.52 12.63 10 171604 35875 110381810
Meningoencephalitis herpetic 28.23 12.63 26 171588 2376 110415309
Diabetes mellitus 28.17 12.63 71 171543 99310 110318375
Aphasia 28.09 12.63 30 171584 58967 110358718
Drug withdrawal syndrome 27.94 12.63 12 171602 38042 110379643
Skin haemorrhage 27.87 12.63 3 171611 24824 110392861
Condition aggravated 27.73 12.63 899 170715 733937 109683748
Pallor 27.69 12.63 28 171586 56439 110361246
Insomnia 27.62 12.63 744 170870 359846 110057839
Pulmonary embolism 27.57 12.63 207 171407 214267 110203418
Prostate cancer 27.43 12.63 12 171602 37629 110380056
Frequent bowel movements 27.20 12.63 197 171417 71193 110346492
Product administration error 26.91 12.63 12 171602 37205 110380480
Dystonia 26.83 12.63 4 171610 25801 110391884
Granuloma skin 26.62 12.63 56 171558 11227 110406458
Diplopia 26.59 12.63 16 171598 41878 110375807
Head injury 26.51 12.63 17 171597 43000 110374685
Heart rate irregular 26.48 12.63 10 171604 34264 110383421
Dermatitis atopic 26.47 12.63 4 171610 25537 110392148
Transfusion 26.37 12.63 4 171610 25468 110392217
Blood immunoglobulin G decreased 26.33 12.63 37 171577 5363 110412322
Pulmonary arterial hypertension 26.02 12.63 9 171605 32559 110385126
Palmar-plantar erythrodysaesthesia syndrome 25.57 12.63 16 171598 41009 110376676
Upper gastrointestinal haemorrhage 25.54 12.63 24 171590 50072 110367613
Metabolic acidosis 25.46 12.63 75 171539 99669 110318016
Ventricular tachycardia 25.45 12.63 24 171590 49985 110367700
Swelling face 25.36 12.63 67 171547 92254 110325431
Spondylitis 25.29 12.63 55 171559 11283 110406402
Sinus congestion 25.06 12.63 8 171606 30451 110387234
Poor venous access 25.05 12.63 4 171610 24518 110393167
Metastases to central nervous system 25.01 12.63 3 171611 22814 110394871
Cerebral haemorrhage 24.79 12.63 39 171575 64929 110352756
Status epilepticus 24.75 12.63 9 171605 31562 110386123
Hypercholesterolaemia 24.58 12.63 232 171382 90605 110327080
Metastases to bone 24.50 12.63 9 171605 31363 110386322
Productive cough 24.35 12.63 93 171521 114212 110303473
Irritability 24.26 12.63 23 171591 47786 110369899
Presyncope 24.25 12.63 24 171590 48863 110368822
Pulmonary hypertension 24.21 12.63 30 171584 55190 110362495
Therapeutic response unexpected 24.11 12.63 4 171610 23839 110393846
Bone pain 24.01 12.63 40 171574 65093 110352592
Forced expiratory volume decreased 23.97 12.63 59 171555 13117 110404568
Urinary incontinence 23.93 12.63 24 171590 48563 110369122
Localised infection 23.92 12.63 19 171595 43029 110374656
Transplant rejection 23.74 12.63 88 171526 24479 110393206
Musculoskeletal discomfort 23.68 12.63 4 171610 23534 110394151
Dyskinesia 23.57 12.63 27 171587 51419 110366266
Injection site rash 23.52 12.63 4 171610 23415 110394270
Product storage error 23.46 12.63 3 171611 21725 110395960
Drug resistance 23.31 12.63 32 171582 56342 110361343
Intervertebral disc protrusion 23.28 12.63 7 171607 27691 110389994
Colitis 23.28 12.63 81 171533 102242 110315443
Fracture 23.27 12.63 5 171609 24783 110392902
Dementia 23.23 12.63 10 171604 31663 110386022
Clostridium difficile infection 23.20 12.63 28 171586 52101 110365584
Cardiac murmur 23.05 12.63 5 171609 24623 110393062
Extrapyramidal disorder 23.02 12.63 8 171606 28859 110388826
Red blood cell sedimentation rate abnormal 22.89 12.63 5 171609 24504 110393181
Skin fissures 22.82 12.63 5 171609 24453 110393232
Rib fracture 22.72 12.63 12 171602 33758 110383927
Multiple organ dysfunction syndrome 22.69 12.63 140 171474 151570 110266115
Pulmonary mass 22.63 12.63 15 171599 37286 110380399
Osteoarthritis 22.33 12.63 403 171211 182220 110235465
Granuloma 22.27 12.63 47 171567 9443 110408242
Body temperature decreased 22.21 12.63 15 171599 36920 110380765
Disability 21.87 12.63 99 171515 30124 110387561
Parkinsonism 21.82 12.63 4 171610 22183 110395502
Gout 21.79 12.63 15 171599 36551 110381134
Metastases to liver 21.78 12.63 14 171600 35372 110382313
Eosinophilic granulomatosis with polyangiitis 21.77 12.63 50 171564 10636 110407049
Gastric ulcer 21.61 12.63 18 171596 39809 110377876
Skin necrosis 21.59 12.63 78 171536 21434 110396251
Hypoacusis 21.56 12.63 14 171600 35177 110382508
Blindness 21.56 12.63 15 171599 36344 110381341
Miosis 21.54 12.63 4 171610 21979 110395706
Hypocalcaemia 21.54 12.63 43 171571 65323 110352362
Pneumonitis 21.44 12.63 55 171559 76476 110341209
Schizophrenia 21.33 12.63 4 171610 21822 110395863
Disorientation 21.20 12.63 49 171565 70622 110347063
Gastroenteritis viral 21.15 12.63 11 171603 31215 110386470
Sleep apnoea syndrome 21.07 12.63 19 171595 40428 110377257
C-reactive protein increased 21.00 12.63 464 171150 217455 110200230
Throat tightness 20.96 12.63 13 171601 33476 110384209
Accidental overdose 20.86 12.63 30 171584 51804 110365881
Nervousness 20.81 12.63 16 171598 36835 110380850
Dry eye 20.81 12.63 34 171580 55759 110361926
Incision site pain 20.79 12.63 25 171589 3110 110414575
Hypertensive crisis 20.78 12.63 6 171608 24366 110393319
Pulmonary oedema 20.74 12.63 83 171531 100576 110317109
Antineutrophil cytoplasmic antibody positive 20.74 12.63 32 171582 5044 110412641
Respiratory tract congestion 20.71 12.63 11 171603 30846 110386839
Polyneuropathy 20.63 12.63 12 171602 32000 110385685
Hepatic cirrhosis 20.48 12.63 177 171437 67449 110350236
Bronchiectasis 20.41 12.63 16 171598 36477 110381208
Swollen joint count 20.41 12.63 43 171571 8631 110409054
Subdural haematoma 20.37 12.63 16 171598 36438 110381247
Hernia 20.33 12.63 3 171611 19497 110398188
Movement disorder 20.31 12.63 16 171598 36388 110381297
Neutropenia 20.26 12.63 435 171179 374185 110043500
Skin disorder 20.23 12.63 22 171592 42891 110374794
Hallucination, visual 20.16 12.63 19 171595 39586 110378099
Hemiparesis 20.16 12.63 23 171591 43880 110373805
Faeces discoloured 20.13 12.63 14 171600 33934 110383751
Glomerular filtration rate decreased 19.91 12.63 10 171604 28946 110388739
Panic attack 19.89 12.63 10 171604 28930 110388755
Seronegative arthritis 19.87 12.63 55 171559 13122 110404563
Sphincter of Oddi dysfunction 19.83 12.63 12 171602 576 110417109
Respiratory failure 19.81 12.63 226 171388 215106 110202579
Head discomfort 19.63 12.63 3 171611 18997 110398688
Malaise 19.51 12.63 848 170766 670971 109746714
Ascites 19.45 12.63 76 171538 92732 110324953
Acute coronary syndrome 19.14 12.63 6 171608 23106 110394579
Affect lability 19.13 12.63 3 171611 18634 110399051
Motor dysfunction 19.06 12.63 7 171607 24399 110393286
Hypersomnia 18.84 12.63 10 171604 28051 110389634
Stevens-Johnson syndrome 18.79 12.63 131 171483 46770 110370915
Mood swings 18.75 12.63 6 171608 22806 110394879
Mood altered 18.71 12.63 5 171609 21370 110396315
Skin laceration 18.63 12.63 15 171599 33738 110383947
Interstitial lung disease 18.61 12.63 133 171481 139201 110278484
Carpal tunnel syndrome 18.49 12.63 6 171608 22604 110395081
Ear infection 18.38 12.63 163 171451 62569 110355116
Cardiomyopathy 18.37 12.63 15 171599 33510 110384175
Delusion 18.24 12.63 7 171607 23748 110393937
Skin discolouration 18.19 12.63 30 171584 49016 110368669
Full blood count decreased 18.05 12.63 14 171600 32085 110385600
Generalised tonic-clonic seizure 17.99 12.63 36 171578 54644 110363041
Mydriasis 17.91 12.63 6 171608 22151 110395534
Muscle spasticity 17.88 12.63 106 171508 35809 110381876
Shock 17.88 12.63 35 171579 53553 110364132
Hypogammaglobulinaemia 17.83 12.63 70 171544 20006 110397679
Dysstasia 17.78 12.63 15 171599 32971 110384714
Hip fracture 17.73 12.63 17 171597 35134 110382551
Blood antidiuretic hormone increased 17.62 12.63 6 171608 71 110417614
Middle insomnia 17.57 12.63 5 171609 20497 110397188
Chills 17.54 12.63 200 171414 190380 110227305
Weight decreased 17.53 12.63 573 171041 467484 109950201
Posterior reversible encephalopathy syndrome 17.52 12.63 16 171598 33845 110383840
Blood potassium decreased 17.49 12.63 36 171578 54078 110363607
Tachycardia 17.45 12.63 247 171367 226398 110191287
Sudden death 17.42 12.63 8 171606 24387 110393298
Rheumatoid lung 17.40 12.63 27 171587 4277 110413408
Metastases to lung 17.37 12.63 7 171607 23056 110394629
Pollakiuria 17.37 12.63 26 171588 44169 110373516
Arthralgia 17.25 12.63 1419 170195 778213 109639472
Cytopenia 17.10 12.63 13 171601 30103 110387582
Joint dislocation 17.08 12.63 101 171513 34089 110383596
Febrile neutropenia 17.07 12.63 368 171246 316399 110101286
Hyperglycaemia 17.00 12.63 71 171543 85019 110332666
Cardiovascular disorder 16.99 12.63 7 171607 22753 110394932
Pain of skin 16.95 12.63 5 171609 20024 110397661
Myelosuppression 16.88 12.63 82 171532 94258 110323427
Peripheral coldness 16.88 12.63 4 171610 18536 110399149
Neurological symptom 16.87 12.63 58 171556 15550 110402135
Spinal pain 16.85 12.63 4 171610 18511 110399174
Joint stiffness 16.85 12.63 169 171445 67074 110350611
Angioedema 16.84 12.63 87 171527 98413 110319272
Spinal fracture 16.83 12.63 7 171607 22626 110395059
Bronchitis 16.82 12.63 159 171455 156873 110260812
Haemodialysis 16.73 12.63 63 171551 17656 110400029
Troponin increased 16.71 12.63 13 171601 29753 110387932
Eye swelling 16.65 12.63 16 171598 33032 110384653
Complications of transplanted kidney 16.48 12.63 36 171578 7406 110410279
Toothache 16.43 12.63 8 171606 23567 110394118
Ulcer haemorrhage 16.38 12.63 74 171540 22497 110395188
Right ventricular failure 16.35 12.63 10 171604 25944 110391741
Left ventricular dysfunction 16.33 12.63 8 171606 23485 110394200
Osteopenia 16.31 12.63 7 171607 22202 110395483
Second primary malignancy 16.25 12.63 4 171610 18064 110399621
Blood loss anaemia 16.19 12.63 4 171610 18021 110399664
Hyperthyroidism 16.15 12.63 13 171601 29248 110388437
Haematuria 16.13 12.63 70 171544 82935 110334750
Sputum discoloured 15.95 12.63 12 171602 27933 110389752
Blood iron decreased 15.89 12.63 5 171609 19209 110398476
Skin cancer 15.87 12.63 4 171610 17780 110399905
Skin burning sensation 15.83 12.63 7 171607 21818 110395867
Haemorrhage intracranial 15.83 12.63 13 171601 28956 110388729
Skin exfoliation 15.79 12.63 76 171538 87575 110330110
Hypoxia 15.70 12.63 127 171487 129388 110288297
Cephalhaematoma 15.67 12.63 4 171610 15 110417670
Red cell distribution width increased 15.63 12.63 4 171610 17598 110400087
Hallucination, auditory 15.50 12.63 11 171603 26386 110391299
Secretion discharge 15.48 12.63 6 171608 20238 110397447
Respiratory tract infection 15.43 12.63 58 171556 71559 110346126
Neutropenic sepsis 15.36 12.63 15 171599 30731 110386954
Hypocholesterolaemia 15.30 12.63 32 171582 6389 110411296
Disease recurrence 15.30 12.63 46 171568 60738 110356947
Stress cardiomyopathy 15.23 12.63 3 171611 15803 110401882
Cytomegalovirus test 15.18 12.63 5 171609 53 110417632
Incorrect route of product administration 15.09 12.63 159 171455 63902 110353783
Blood pressure systolic abnormal 15.07 12.63 10 171604 24840 110392845
Liver transplant rejection 15.03 12.63 24 171590 3894 110413791
Iron deficiency 14.94 12.63 5 171609 18471 110399214
Delayed graft function 14.88 12.63 25 171589 4232 110413453
Dysuria 14.86 12.63 46 171568 60185 110357500
Mouth ulceration 14.75 12.63 33 171581 48105 110369580
Trimethylaminuria 14.64 12.63 7 171607 208 110417477
Myocarditis 14.63 12.63 15 171599 30040 110387645
Onychomadesis 14.61 12.63 121 171493 45542 110372143
Spinal fusion surgery 14.59 12.63 39 171575 9117 110408568
Abdominal pain lower 14.59 12.63 22 171592 37261 110380424
Pulmonary alveolar haemorrhage 14.58 12.63 66 171548 20084 110397601
Cold sweat 14.57 12.63 8 171606 22023 110395662
Onychomycosis 14.49 12.63 106 171508 38425 110379260
Hypothyroidism 14.46 12.63 61 171553 72838 110344847
Oral herpes 14.40 12.63 21 171593 36059 110381626
Blood calcium increased 14.38 12.63 5 171609 18035 110399650
Biopsy liver abnormal 14.36 12.63 9 171605 460 110417225
Micturition urgency 14.33 12.63 6 171608 19314 110398371
Cardiac failure acute 14.19 12.63 10 171604 24068 110393617
Muscle rigidity 14.13 12.63 10 171604 24021 110393664
Vena cava injury 14.02 12.63 8 171606 344 110417341
Synovial fluid analysis 14.02 12.63 19 171595 2662 110415023
Shock haemorrhagic 13.95 12.63 13 171601 27234 110390451
Thrombosis 13.90 12.63 105 171509 108557 110309128
Apathy 13.84 12.63 4 171610 16235 110401450
Emotional disorder 13.74 12.63 4 171610 16156 110401529
HIV wasting syndrome 13.66 12.63 5 171609 74 110417611
Blood pressure diastolic abnormal 13.60 12.63 12 171602 25803 110391882
Paranoia 13.57 12.63 9 171605 22365 110395320
Eye infection 13.48 12.63 3 171611 14515 110403170
Septic shock 13.46 12.63 168 171446 157360 110260325
Muscle twitching 13.40 12.63 16 171598 29919 110387766
Ankle fracture 13.40 12.63 7 171607 19812 110397873
Crying 13.39 12.63 12 171602 25616 110392069
Vitamin D deficiency 13.38 12.63 6 171608 18546 110399139
Myoclonus 13.37 12.63 19 171595 32979 110384706
Orbital haemorrhage 13.37 12.63 4 171610 30 110417655
Kidney infection 13.36 12.63 12 171602 25587 110392098
Upper-airway cough syndrome 13.34 12.63 4 171610 15853 110401832
Emphysema 13.32 12.63 7 171607 19749 110397936
Immunodeficiency 13.27 12.63 25 171589 38813 110378872
Blood pressure systolic increased 13.25 12.63 75 171539 82916 110334769
Febrile bone marrow aplasia 13.23 12.63 58 171556 17407 110400278
Upper limb fracture 13.22 12.63 8 171606 20880 110396805
Blood calcium decreased 13.22 12.63 22 171592 35823 110381862
Ageusia 13.19 12.63 7 171607 19638 110398047
Gingival pain 13.18 12.63 4 171610 15732 110401953
Subarachnoid haemorrhage 13.17 12.63 16 171598 29686 110387999
Congestive cardiomyopathy 13.08 12.63 3 171611 14216 110403469
Thyroid disorder 13.03 12.63 5 171609 16964 110400721
Drug effective for unapproved indication 13.01 12.63 3 171611 14164 110403521
Coordination abnormal 12.96 12.63 12 171602 25216 110392469
Acute hepatic failure 12.89 12.63 23 171591 36445 110381240
Human herpesvirus 6 infection reactivation 12.84 12.63 12 171602 1117 110416568
Perinephric collection 12.84 12.63 8 171606 405 110417280
Thirst 12.81 12.63 9 171605 21698 110395987
SARS-CoV-2 antibody test positive 12.80 12.63 8 171606 407 110417278
Vaginal haemorrhage 12.80 12.63 12 171602 25062 110392623
Groin pain 12.79 12.63 4 171610 15424 110402261
Mitral valve incompetence 12.72 12.63 20 171594 33309 110384376
Temperature intolerance 12.72 12.63 3 171611 13947 110403738

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01EC01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
SULFONAMIDES AND TRIMETHOPRIM
Intermediate-acting sulfonamides
ATC J01EE01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
SULFONAMIDES AND TRIMETHOPRIM
Combinations of sulfonamides and trimethoprim, incl. derivatives
ATC J04AM08 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIMYCOBACTERIALS
DRUGS FOR TREATMENT OF TUBERCULOSIS
Combinations of drugs for treatment of tuberculosis
FDA CS M0020790 Sulfonamides
FDA EPC N0000175504 Sulfonamide Antimicrobial
MeSH PA D000890 Anti-Infective Agents
FDA MoA N0000185504 Cytochrome P450 2C9 Inhibitors
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:35526 hypoglycemic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:35718 antifungal agent
CHEBI has role CHEBI:38068 antimalarial
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:50183 P450 inhibitor
CHEBI has role CHEBI:50502 EC 2.5.1.15 (dihydropteroate synthase) inhibitor
CHEBI has role CHEBI:53000 epitope
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:74234 EC 1.1.1.153 [sepiapterin reductase (<small>L</small>-<i>erythro</i>-7,8-dihydrobiopterin forming)] inhibitor
CHEBI has role CHEBI:78298 environmental contaminant
CHEBI has role CHEBI:88188 drug allergen
CHEBI has role CHEBI:231911 renoprotective agent
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

J01EC Intermediate-acting sulfonamides 2 drugs
sulfadiazinesulfamoxole
J01EE Combinations of sulfonamides and trimethoprim, incl. derivatives 7 drugs
sulfadiazinesulfadimidinesulfamerazinesulfametrolesulfamoxoletetroxoprimtrimethoprim
J04AM Combinations of drugs for treatment of tuberculosis 11 drugs
ethambutolisoniazidlevofloxacinlomefloxacinprotionamidepyrazinamiderifabutinrifampicinstreptomycinthioacetazonetrimethoprim

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

DiseaseRelationSNOMED_IDDOID
Acute otitis media indication 3110003
Haemophilus Influenzae Acute Otitis Media indication 19021002
Nocardiosis indication 29227009 DOID:2312
Shigellosis indication 36188001
Klebsiella cystitis indication 60867007
Toxoplasmosis indication 187192000 DOID:9965
Chlamydial conjunctivitis indication 231861005 DOID:13800
Escherichia coli urinary tract infection indication 301011002
Proteus urinary tract infection indication 301012009
Bacterial urinary infection indication 312124009
Infective otitis media indication 312218008
Pneumocystosis jiroveci pneumonia indication 415125002 DOID:11339
Acute exacerbation of chronic bronchitis indication 425748003
Haemophilus Influenzae Chronic Bronchitis indication
Aerobic Gram-Positive Cocci Infection indication
Pneumocystis Carinii Pneumonia Prevention indication
Aerobic Gram-Negative Bacillary Infection indication
Morganella Morganii Urinary Tract Infection indication
Streptococcus Pneumoniae Chronic Bronchitis indication
Typhoid fever off-label use 4834000 DOID:13258
Infection of skin AND/OR subcutaneous tissue off-label use 19824006
Pertussis off-label use 27836007
Granuloma inguinale off-label use 28867007 DOID:9113
Listeria meningitis off-label use 31568009 DOID:11572
Sinusitis off-label use 36971009
Whipple's disease off-label use 41545003 DOID:8476
Bacterial pneumonia off-label use 53084003 DOID:874
Paracoccidioidomycosis off-label use 59925007 DOID:12662
Cholera off-label use 63650001 DOID:1498
Brucellosis off-label use 75702008 DOID:11077
Paratyphoid fever off-label use 85904008 DOID:3055
Chlamydial infection off-label use 105629000
Infection of bone off-label use 111253001
Meningococcus carrier off-label use 170486006
Lymphogranuloma venereum off-label use 186946009 DOID:13819
Chancroid off-label use 266143009 DOID:13778
Diverticulitis of gastrointestinal tract off-label use 271366000
Bacterial endocarditis off-label use 301183007
Toxoplasmosis associated with acquired immunodeficiency syndrome off-label use 421666009
Diabetic Foot Infection off-label use
Toxoplasmosis Prevention off-label use
Postexposure Plague Prophylaxis off-label use
Chronic Bacterial Prostatitis off-label use
Glomerulonephritis contraindication 36171008 DOID:2921
Acute hepatitis contraindication 37871000
Third trimester pregnancy contraindication 41587001
Uremia contraindication 44730006 DOID:4676
Megaloblastic anemia due to folate deficiency contraindication 85649008 DOID:14026
Kidney disease contraindication 90708001 DOID:557
Anemia due to enzyme deficiency contraindication 111577008
Deficiency of glucose-6-phosphate dehydrogenase contraindication 124134002 DOID:2862
Folic acid deficiency contraindication 190633005
Disease of liver contraindication 235856003 DOID:409
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Pseudomembranous enterocolitis contraindication 397683000
Porphyria contraindication 418470004




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.79 acidic
pKa2 2.08 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Dihydropteroate synthase Enzyme INHIBITOR IC50 5.33 CHEMBL CHEMBL
Bifunctional protein FolC Enzyme WOMBAT-PK
Dihydrofolate reductase Enzyme IC50 7 CHEMBL
Pol polyprotein Enzyme Ki 8 CHEMBL
Endothelin-1 receptor GPCR IC50 5.40 CHEMBL

External reference:

IDSource
4017734 VUID
N0000146102 NUI
D00447 KEGG_DRUG
4017734 VANDF
C0038689 UMLSCUI
CHEBI:9332 CHEBI
08D PDB_CHEM_ID
CHEMBL443 ChEMBL_ID
DB01015 DRUGBANK_ID
D013420 MESH_DESCRIPTOR_UI
5329 PUBCHEM_CID
10933 IUPHAR_LIGAND_ID
1386 INN_ID
JE42381TNV UNII
10180 RXNORM
2035 MMSL
5526 MMSL
d00119 MMSL
002827 NDDF
363528007 SNOMEDCT_US
70047000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0121-0853 SUSPENSION 200 mg ORAL NDA 23 sections
SULFATRIM HUMAN PRESCRIPTION DRUG LABEL 2 0121-0854 SUSPENSION 200 mg ORAL NDA 26 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0440-2406 TABLET 800 mg ORAL ANDA 13 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0615-8121 TABLET 800 mg ORAL ANDA 26 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0703-9503 INJECTION, SOLUTION, CONCENTRATE 80 mg INTRAVENOUS ANDA 25 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0703-9514 INJECTION, SOLUTION, CONCENTRATE 80 mg INTRAVENOUS ANDA 25 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0703-9514 INJECTION, SOLUTION, CONCENTRATE 80 mg INTRAVENOUS ANDA 25 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0703-9514 INJECTION, SOLUTION, CONCENTRATE 80 mg INTRAVENOUS ANDA 25 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0703-9526 INJECTION, SOLUTION, CONCENTRATE 80 mg INTRAVENOUS ANDA 25 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0703-9526 INJECTION, SOLUTION, CONCENTRATE 80 mg INTRAVENOUS ANDA 25 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0904-2725 TABLET 800 mg ORAL ANDA 13 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 10544-053 TABLET 800 mg ORAL ANDA 26 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 10544-092 TABLET 800 mg ORAL ANDA 25 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 10544-525 TABLET 800 mg ORAL ANDA 13 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 10544-926 TABLET 800 mg ORAL ANDA 13 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 10544-940 TABLET 800 mg ORAL ANDA 27 sections
Sulfamethoxazole and Trimethoprim DS HUMAN PRESCRIPTION DRUG LABEL 2 12634-177 TABLET 800 mg ORAL ANDA 21 sections
SULFAMETHOXAZOLE and TRIMETHOPRIM HUMAN PRESCRIPTION DRUG LABEL 2 12634-779 SUSPENSION 200 mg ORAL ANDA 21 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 16590-210 TABLET 800 mg ORAL ANDA 29 sections
SULFATRIM HUMAN PRESCRIPTION DRUG LABEL 2 17856-0007 SUSPENSION 200 mg ORAL NDA 21 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 17856-0496 SUSPENSION 200 mg ORAL ANDA 26 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 17856-0823 SUSPENSION 200 mg ORAL ANDA 20 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 17856-5181 SUSPENSION 200 mg ORAL ANDA 21 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 21695-125 TABLET 800 mg ORAL ANDA 13 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 21695-701 SUSPENSION 200 mg ORAL ANDA 20 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 33261-148 TABLET 800 mg ORAL ANDA 13 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 33261-396 TABLET 400 mg ORAL ANDA 13 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 42291-758 TABLET 400 mg ORAL ANDA 13 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 42291-759 TABLET 800 mg ORAL ANDA 13 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 42708-053 TABLET 800 mg ORAL ANDA 26 sections