sulfamethoxazole ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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) 0.39 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 14 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 394.82 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.30 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

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
Muscle injury 1104.19 11.97 632 58841 36479 50509172
Folliculitis 1092.71 11.97 640 58833 38585 50507066
Sleep disorder due to general medical condition, insomnia type 1067.40 11.97 584 58889 30863 50514788
Irritable bowel syndrome 959.57 11.97 651 58822 50790 50494861
Impaired healing 771.98 11.97 646 58827 69140 50476511
Blister 706.87 11.97 671 58802 84747 50460904
Gastrointestinal disorder 677.20 11.97 686 58787 93770 50451881
Stomatitis 642.22 11.97 689 58784 100655 50444996
Lower respiratory tract infection 623.99 11.97 659 58814 94542 50451109
Duodenal ulcer perforation 532.70 11.97 436 59037 45175 50500476
Ill-defined disorder 531.03 11.97 470 59003 54184 50491467
Helicobacter infection 510.14 11.97 441 59032 49261 50496390
Infection 416.70 11.97 736 58737 172218 50373433
Therapeutic product effect decreased 405.33 11.97 637 58836 135413 50410238
Confusional state 398.32 11.97 752 58721 185176 50360475
Sinusitis 371.66 11.97 695 58778 169863 50375788
Pyrexia 356.15 11.97 1116 58357 379087 50166564
Anti-cyclic citrullinated peptide antibody positive 345.13 11.97 420 59053 70167 50475484
Pericarditis 344.52 11.97 443 59030 78246 50467405
Nasopharyngitis 290.91 11.97 676 58797 192251 50353400
Weight increased 289.89 11.97 694 58779 201197 50344454
Hypersensitivity 287.06 11.97 719 58754 214442 50331209
Peripheral swelling 280.84 11.97 694 58779 205242 50340409
Contusion 274.41 11.97 481 58992 111702 50433949
Swelling 272.90 11.97 676 58797 200196 50345455
Synovitis 254.98 11.97 493 58980 123372 50422279
Hand deformity 248.10 11.97 432 59041 99767 50445884
Discomfort 244.95 11.97 449 59024 107931 50437720
Joint swelling 218.84 11.97 709 58764 244577 50301074
Pruritus 217.38 11.97 779 58694 282789 50262862
Arthropathy 206.47 11.97 524 58949 157382 50388269
Glossodynia 205.59 11.97 433 59040 115136 50430515
Hepatic enzyme increased 202.03 11.97 477 58996 136903 50408748
Wound 200.65 11.97 407 59066 105387 50440264
Pemphigus 196.33 11.97 435 59038 119731 50425920
Infusion related reaction 163.73 11.97 504 58969 169053 50376598
Systemic lupus erythematosus 161.71 11.97 445 59028 140177 50405474
Fall 151.91 11.97 104 59369 334828 50210823
Rash 146.55 11.97 946 58527 436525 50109126
Product dose omission issue 146.42 11.97 21 59452 183817 50361834
Death 129.83 11.97 115 59358 325264 50220387
Dizziness 112.97 11.97 145 59328 346224 50199427
Toxicity to various agents 110.33 11.97 56 59417 212443 50333208
Completed suicide 109.95 11.97 13 59460 131876 50413775
Contraindicated product administered 109.36 11.97 404 59069 148554 50397097
Off label use 108.65 11.97 249 59224 474177 50071474
Pain in extremity 102.25 11.97 102 59371 272763 50272888
Abdominal discomfort 102.00 11.97 539 58934 231102 50314549
Malaise 97.92 11.97 152 59321 335380 50210271
Nausea 97.45 11.97 463 59010 704935 49840716
Pre-engraftment immune reaction 92.12 11.97 26 59447 212 50545439
Drug intolerance 89.79 11.97 500 58973 218604 50327047
Headache 89.08 11.97 302 59171 506233 50039418
Injection site pain 85.34 11.97 14 59459 111010 50434641
Blood pressure increased 72.23 11.97 33 59440 133099 50412552
Feeling abnormal 69.82 11.97 30 59443 125462 50420189
Diarrhoea 67.38 11.97 411 59062 588065 49957586
Alanine aminotransferase abnormal 66.59 11.97 48 59425 4108 50541543
Rheumatoid arthritis 66.24 11.97 436 59037 202114 50343537
Cough 64.10 11.97 116 59357 241148 50304503
Encephalitis viral 63.49 11.97 33 59440 1564 50544087
Red blood cell sedimentation rate 63.44 11.97 44 59429 3542 50542109
Intentional overdose 60.91 11.97 3 59470 62501 50483150
Arthralgia 59.94 11.97 782 58691 437920 50107731
Human herpesvirus 6 infection 55.78 11.97 36 59437 2570 50543081
Therapeutic product effect incomplete 53.97 11.97 20 59453 91495 50454156
Condition aggravated 53.51 11.97 175 59298 296883 50248768
Pneumonia 53.39 11.97 246 59227 378155 50167496
Fear of injection 50.43 11.97 48 59425 6055 50539596
Injection site erythema 50.24 11.97 13 59460 74923 50470728
Medication error 49.33 11.97 122 59351 35982 50509669
Muscle spasms 49.20 11.97 45 59428 125508 50420143
Alopecia 48.48 11.97 470 59003 244577 50301074
Drug abuse 47.22 11.97 7 59466 59839 50485812
Inappropriate schedule of product administration 47.14 11.97 13 59460 71818 50473833
Injection site reaction 46.90 11.97 3 59470 50029 50495622
Tongue disorder 46.85 11.97 56 59417 9160 50536491
Psoriasis 46.20 11.97 12 59461 68988 50476663
Enthesopathy 45.57 11.97 49 59424 7144 50538507
Weight decreased 45.10 11.97 123 59350 221122 50324529
Back pain 45.10 11.97 122 59351 219908 50325743
Cytomegalovirus infection 45.08 11.97 78 59395 17884 50527767
Gait disturbance 44.57 11.97 67 59406 149938 50395713
Depression 44.38 11.97 79 59394 165344 50380307
Blood parathyroid hormone decreased 44.26 11.97 48 59425 7066 50538585
Pregnancy 41.53 11.97 101 59372 29476 50516175
Wrong technique in product usage process 40.48 11.97 8 59465 55502 50490149
COVID-19 40.39 11.97 4 59469 46658 50498993
Dyspnoea 39.39 11.97 880 58593 546728 49998923
Balance disorder 39.05 11.97 17 59456 70573 50475078
Panniculitis 38.91 11.97 49 59424 8454 50537197
Suicide attempt 38.69 11.97 7 59466 51725 50493926
Visual impairment 36.89 11.97 17 59456 68258 50477393
Memory impairment 36.73 11.97 24 59449 79336 50466315
Skin necrosis 36.64 11.97 54 59419 10813 50534838
Kidney transplant rejection 36.11 11.97 33 59440 3954 50541697
Myocardial infarction 35.96 11.97 31 59442 88996 50456655
Intentional product misuse 35.66 11.97 6 59467 46728 50498923
Constipation 34.37 11.97 108 59365 185600 50360051
Flushing 34.22 11.97 18 59455 66997 50478654
Migraine 33.20 11.97 24 59449 75256 50470395
Maternal exposure timing unspecified 32.86 11.97 30 59443 3590 50542061
Oropharyngeal pain 32.78 11.97 26 59447 77775 50467876
Hyperhidrosis 32.77 11.97 34 59439 89392 50456259
Syncope 32.57 11.97 44 59429 102958 50442693
Hypertension 32.34 11.97 133 59340 211070 50334581
Injection site bruising 32.22 11.97 3 59470 36765 50508886
Tenosynovitis 32.08 11.97 50 59423 10515 50535136
Therapy non-responder 31.38 11.97 131 59342 50891 50494760
Influenza 30.66 11.97 36 59437 89502 50456149
Injection site swelling 30.50 11.97 6 59467 41767 50503884
Anxiety 30.32 11.97 107 59366 177499 50368152
Fluid retention 29.97 11.97 11 59462 50638 50495013
Asthenia 29.85 11.97 236 59237 318806 50226845
Breast cancer 29.60 11.97 7 59466 42883 50502768
Suicidal ideation 29.60 11.97 14 59459 55371 50490280
Cerebrovascular accident 29.38 11.97 41 59432 94639 50451012
Paraesthesia 29.12 11.97 61 59412 120182 50425469
Meningoencephalitis herpetic 28.50 11.97 17 59456 1055 50544596
Loss of consciousness 27.82 11.97 50 59423 104303 50441348
Granuloma skin 27.38 11.97 34 59439 5784 50539867
Urinary tract infection 27.34 11.97 153 59320 223867 50321784
Injection site pruritus 27.10 11.97 7 59466 40404 50505247
Deafness transitory 27.09 11.97 20 59453 1776 50543875
Hepatic cytolysis 26.94 11.97 40 59433 8063 50537588
Depressed mood 26.79 11.97 4 59469 34019 50511632
Stress 26.66 11.97 15 59458 53778 50491873
Vomiting 26.43 11.97 382 59091 460376 50085275
Overdose 26.39 11.97 48 59425 99679 50445972
Blood creatinine increased 26.09 11.97 166 59307 75994 50469657
Chest discomfort 26.02 11.97 43 59430 92679 50452972
Multiple sclerosis relapse 25.99 11.97 9 59464 42955 50502696
Complications of transplanted kidney 25.80 11.97 21 59452 2152 50543499
Unevaluable event 25.62 11.97 11 59462 46055 50499596
Palpitations 25.45 11.97 45 59428 94461 50451190
Rheumatoid nodule 25.29 11.97 50 59423 12685 50532966
Cataract 25.21 11.97 12 59461 47288 50498363
Febrile bone marrow aplasia 25.19 11.97 34 59439 6277 50539374
Dyspepsia 25.14 11.97 30 59443 74067 50471584
Blood pressure fluctuation 24.42 11.97 6 59467 35817 50509834
Maternal exposure during pregnancy 24.35 11.97 291 59182 159487 50386164
HIV infection 24.33 11.97 10 59463 274 50545377
Atrial fibrillation 24.31 11.97 52 59421 101693 50443958
Nasal congestion 24.28 11.97 15 59458 51105 50494546
Stevens-Johnson syndrome 24.11 11.97 68 59405 21684 50523967
Myalgia 23.92 11.97 71 59402 124248 50421403
Deep vein thrombosis postoperative 23.90 11.97 18 59455 1647 50544004
Hot flush 23.86 11.97 11 59462 44158 50501493
Hospitalisation 23.59 11.97 27 59446 67910 50477741
Drug eruption 23.48 11.97 71 59402 23535 50522116
Haematochezia 23.03 11.97 9 59464 39873 50505778
Osteoporosis 22.99 11.97 12 59461 44867 50500784
Cardiac disorder 22.76 11.97 11 59462 42968 50502683
Femur fracture 22.40 11.97 8 59465 37456 50508195
Dysphonia 22.09 11.97 9 59464 38883 50506768
Foetal exposure during pregnancy 22.05 11.97 3 59470 27356 50518295
Rhinorrhoea 22.02 11.97 17 59456 51566 50494085
Aspartate aminotransferase increased 21.96 11.97 162 59311 77836 50467815
Incorrect dose administered 21.92 11.97 15 59458 48399 50497252
Asthma 21.90 11.97 45 59428 89292 50456359
Agranulocytosis 21.84 11.97 65 59408 21356 50524295
Neck pain 21.70 11.97 21 59452 57046 50488605
Coma 21.38 11.97 127 59346 56752 50488899
Cardiac failure congestive 21.11 11.97 42 59431 84340 50461311
Throat irritation 20.74 11.97 5 59468 30234 50515417
Musculoskeletal pain 20.69 11.97 33 59440 72144 50473507
Granuloma 20.66 11.97 27 59446 4831 50540820
No adverse event 20.37 11.97 7 59466 33571 50512080
Tendonitis 20.28 11.97 54 59419 16651 50529000
Exposure during pregnancy 19.92 11.97 74 59399 120941 50424710
Influenza like illness 19.77 11.97 23 59450 57436 50488215
Injury 19.54 11.97 111 59362 48814 50496837
Osteoarthritis 19.08 11.97 32 59441 68574 50477077
Pancytopenia 19.00 11.97 166 59307 83864 50461787
Dry eye 18.94 11.97 7 59466 32088 50513563
Heart rate increased 18.86 11.97 39 59434 77211 50468440
Dry mouth 18.79 11.97 23 59450 56155 50489496
Oxygen saturation decreased 18.72 11.97 36 59437 73212 50472439
Vertigo 18.65 11.97 20 59453 51812 50493839
Acquired immunodeficiency syndrome 18.60 11.97 6 59467 80 50545571
Full blood count abnormal 17.85 11.97 3 59470 23385 50522266
Drug hypersensitivity 17.82 11.97 403 59070 250607 50295044
Pneumonia aspiration 17.82 11.97 78 59395 30926 50514725
Autoimmune disorder 17.81 11.97 28 59445 5932 50539719
Product quality issue 17.76 11.97 7 59466 30851 50514800
Device expulsion 17.49 11.97 6 59467 28816 50516835
Mobility decreased 17.37 11.97 43 59430 79905 50465746
Pain in jaw 17.27 11.97 12 59461 38416 50507235
Alanine aminotransferase increased 17.19 11.97 169 59304 88190 50457461
Surgery 17.14 11.97 7 59466 30198 50515453
Hypoaesthesia 17.14 11.97 84 59389 127173 50418478
Cardio-respiratory arrest 17.05 11.97 23 59450 53869 50491782
Bradycardia 17.05 11.97 31 59442 64395 50481256
Transplant rejection 17.04 11.97 36 59437 9573 50536078
Cytomegalovirus test positive 17.03 11.97 18 59455 2574 50543077
Bronchitis 16.94 11.97 64 59409 104095 50441556
Intestinal obstruction 16.89 11.97 5 59468 26378 50519273
Bacterial sepsis 16.82 11.97 21 59452 3591 50542060
Abdominal distension 16.80 11.97 38 59435 72865 50472786
Abdominal pain 16.80 11.97 187 59286 236041 50309610
Limb discomfort 16.76 11.97 4 59469 24353 50521298
Vision blurred 16.54 11.97 43 59430 78604 50467047
Muscular weakness 16.36 11.97 57 59416 94956 50450695
Toxic epidermal necrolysis 16.26 11.97 58 59415 20934 50524717
Renal tubular disorder 16.14 11.97 17 59456 2420 50543231
Sedation 15.95 11.97 8 59465 30602 50515049
Hypotension 15.73 11.97 189 59284 235280 50310371
Chemotherapeutic drug level increased 15.70 11.97 6 59467 135 50545516
Fibromyalgia 15.48 11.97 18 59455 44960 50500691
Nephrolithiasis 15.37 11.97 11 59462 34682 50510969
Product prescribing error 15.32 11.97 3 59470 20958 50524693
Abdominal pain upper 15.26 11.97 117 59356 159192 50386459
Drug reaction with eosinophilia and systemic symptoms 15.20 11.97 70 59403 28354 50517297
Dysgeusia 15.17 11.97 14 59459 38902 50506749
Ulcer 14.96 11.97 55 59418 20145 50525506
Hypothyroidism 14.88 11.97 11 59462 34114 50511537
Cognitive disorder 14.82 11.97 18 59455 44105 50501546
Cholecystitis chronic 14.63 11.97 34 59439 9635 50536016
Hepatitis fulminant 14.55 11.97 18 59455 3050 50542601
Anaphylactic shock 14.49 11.97 3 59470 20152 50525499
Immunosuppressant drug level increased 14.48 11.97 18 59455 3064 50542587
Functional gastrointestinal disorder 14.44 11.97 19 59454 3423 50542228
Disease progression 14.26 11.97 61 59412 95805 50449846
Bronchopulmonary aspergillosis 14.11 11.97 29 59444 7563 50538088
Drug dependence 14.09 11.97 3 59470 19756 50525895
Arrhythmia 14.04 11.97 11 59462 33121 50512530
Oral pain 13.89 11.97 6 59467 25027 50520624
Chronic obstructive pulmonary disease 13.88 11.97 26 59447 53409 50492242
Wheezing 13.77 11.97 33 59440 62014 50483637
Serotonin syndrome 13.59 11.97 6 59467 24707 50520944
Osteonecrosis of jaw 13.53 11.97 11 59462 32515 50513136
Herpes zoster 13.20 11.97 41 59432 70745 50474906
Feeling hot 13.16 11.97 16 59457 39186 50506465
Upper respiratory tract infection 13.13 11.97 37 59436 65861 50479790
Dry skin 13.10 11.97 19 59454 43172 50502479
Purpura senile 13.06 11.97 8 59465 521 50545130
Joint stiffness 12.92 11.97 10 59463 30298 50515353
Tarsal tunnel syndrome 12.92 11.97 8 59465 531 50545120
Drug ineffective 12.87 11.97 811 58662 818522 49727129
Blood glucose increased 12.81 11.97 42 59431 71282 50474369
Pneumocystis jirovecii pneumonia 12.65 11.97 42 59431 14621 50531030
Lung transplant rejection 12.59 11.97 9 59464 760 50544891
Trimethylaminuria 12.31 11.97 5 59468 133 50545518
Device dislocation 12.21 11.97 5 59468 21541 50524110
Diabetic ketoacidosis 12.17 11.97 3 59470 17869 50527782
Angina pectoris 12.00 11.97 8 59465 26180 50519471

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
Pyrexia 138.01 11.59 681 33851 286941 29253054
Drug ineffective 116.15 11.59 153 34379 363017 29176978
Cytomegalovirus infection 99.50 11.59 129 34403 23086 29516909
Lymphocyte count decreased 93.60 11.59 114 34418 19157 29520838
Immune reconstitution inflammatory syndrome 90.18 11.59 74 34458 7728 29532267
Hyperkalaemia 87.68 11.59 210 34322 61182 29478813
Death 85.84 11.59 169 34363 341915 29198080
Off label use 83.11 11.59 140 34392 300660 29239335
Neutropenia 81.66 11.59 337 34195 131374 29408621
Aspartate aminotransferase increased 80.70 11.59 200 34332 59525 29480470
Alanine aminotransferase increased 78.98 11.59 221 34311 70723 29469272
Blood creatinine increased 77.59 11.59 247 34285 84855 29455140
Pancytopenia 77.31 11.59 243 34289 82925 29457070
Stevens-Johnson syndrome 75.94 11.59 95 34437 16402 29523593
Hepatic cytolysis 73.89 11.59 68 34464 8279 29531716
Transplant rejection 73.80 11.59 71 34461 9141 29530854
Clear cell renal cell carcinoma 71.39 11.59 31 34501 984 29539011
Lymphoproliferative disorder 64.65 11.59 39 34493 2488 29537507
Acute kidney injury 60.33 11.59 521 34011 264746 29275249
Kidney transplant rejection 58.03 11.59 55 34477 6950 29533045
Product dose omission issue 56.41 11.59 21 34511 96362 29443633
Blood urea increased 49.99 11.59 105 34427 28007 29511988
Pneumocystis jirovecii pneumonia 49.41 11.59 78 34454 16701 29523294
Renal tubular necrosis 45.58 11.59 69 34463 14246 29525749
Cytomegalovirus viraemia 43.76 11.59 45 34487 6275 29533720
Blood lactate dehydrogenase increased 42.94 11.59 79 34453 19130 29520865
Alanine aminotransferase abnormal 42.72 11.59 32 34500 2925 29537070
Agranulocytosis 40.95 11.59 80 34452 20260 29519735
Pre-engraftment immune reaction 39.23 11.59 11 34521 88 29539907
Tenosynovitis 38.17 11.59 33 34499 3700 29536295
Fall 37.35 11.59 96 34436 177082 29362913
Hospitalisation 36.86 11.59 5 34527 45983 29494012
Rash maculo-papular 36.71 11.59 85 34447 24204 29515791
Thrombocytopenia 36.59 11.59 276 34256 134547 29405448
Cholestasis 36.44 11.59 83 34449 23379 29516616
Leukopenia 36.30 11.59 144 34388 55059 29484936
Enthesopathy 36.09 11.59 32 34500 3711 29536284
Product use issue 35.98 11.59 8 34524 51436 29488559
Tongue disorder 35.75 11.59 35 34497 4601 29535394
Inappropriate schedule of product administration 35.26 11.59 5 34527 44467 29495528
Blood bilirubin increased 35.16 11.59 103 34429 33790 29506205
Hepatitis 33.93 11.59 75 34457 20708 29519287
Rash 33.66 11.59 354 34178 189465 29350530
Platelet count decreased 33.47 11.59 223 34309 104449 29435546
Haemodialysis 33.15 11.59 49 34483 9905 29530090
Aplasia pure red cell 32.54 11.59 36 34496 5455 29534540
Toxicity to various agents 32.23 11.59 100 34432 173561 29366434
Liver transplant rejection 29.94 11.59 22 34510 1952 29538043
Incision site pain 29.62 11.59 21 34511 1762 29538233
Toxic skin eruption 29.61 11.59 46 34486 9711 29530284
Haemoglobin decreased 28.90 11.59 221 34311 108154 29431841
Foetal exposure during pregnancy 28.83 11.59 3 34529 33864 29506131
White blood cell count decreased 28.10 11.59 180 34352 83182 29456813
Encephalitis viral 27.75 11.59 17 34515 1115 29538880
Sphincter of Oddi dysfunction 27.50 11.59 9 34523 127 29539868
Osteoporotic fracture 27.19 11.59 16 34516 975 29539020
HIV infection 27.08 11.59 17 34515 1164 29538831
Plasma cell myeloma 27.00 11.59 100 34432 37015 29502980
Fatigue 26.77 11.59 239 34293 316582 29223413
Red blood cells urine positive 26.18 11.59 19 34513 1654 29538341
Delayed graft function 25.95 11.59 20 34512 1907 29538088
Cerebrovascular accident 25.88 11.59 31 34501 76880 29463115
Blood antidiuretic hormone increased 25.78 11.59 7 34525 49 29539946
C-reactive protein increased 25.58 11.59 111 34421 44152 29495843
Intentional overdose 24.98 11.59 7 34525 38521 29501474
Tendonitis 24.81 11.59 38 34494 7923 29532072
Granuloma skin 24.73 11.59 13 34519 635 29539360
Aspergillus infection 24.26 11.59 44 34488 10537 29529458
Asthma 24.20 11.59 5 34527 33844 29506151
Dialysis 24.11 11.59 43 34489 10165 29529830
Pneumonia cytomegaloviral 24.03 11.59 22 34510 2660 29537335
Therapeutic product effect incomplete 23.94 11.59 8 34524 39297 29500698
Kaposi's sarcoma 23.87 11.59 14 34518 848 29539147
Red blood cell sedimentation rate 23.70 11.59 12 34520 542 29539453
Acquired immunodeficiency syndrome 23.53 11.59 11 34521 416 29539579
Drug reaction with eosinophilia and systemic symptoms 23.44 11.59 79 34453 27913 29512082
Graft versus host disease 23.31 11.59 41 34491 9587 29530408
Peripheral swelling 23.30 11.59 24 34508 63715 29476280
Hepatitis cholestatic 23.05 11.59 34 34498 6859 29533136
Lymphocele 22.85 11.59 16 34516 1316 29538679
Human herpesvirus 6 infection 22.22 11.59 18 34514 1845 29538150
Neutrophil count decreased 22.01 11.59 105 34427 43462 29496533
Gamma-glutamyltransferase increased 21.98 11.59 75 34457 26662 29513333
Blood alkaline phosphatase increased 21.90 11.59 78 34454 28328 29511667
Panniculitis 21.73 11.59 15 34517 1206 29538789
Hepatomegaly 21.68 11.59 39 34493 9278 29530717
Tubulointerstitial nephritis 21.63 11.59 57 34475 17586 29522409
C-reactive protein abnormal 21.51 11.59 32 34500 6504 29533491
Dizziness 21.28 11.59 132 34400 189552 29350443
Dyspnoea 21.26 11.59 262 34270 326470 29213525
Serum sickness 20.94 11.59 17 34515 1748 29538247
Weight increased 20.77 11.59 36 34496 76631 29463364
Syncope 20.45 11.59 40 34492 81331 29458664
Renal failure 20.42 11.59 220 34312 118379 29421616
Chronic lymphocytic leukaemia 20.13 11.59 23 34509 3610 29536385
Culture urine positive 20.02 11.59 14 34518 1149 29538846
Parvovirus infection 20.01 11.59 10 34522 439 29539556
Therapeutic product effect decreased 19.76 11.59 5 34527 29446 29510549
Intentional product misuse 19.52 11.59 8 34524 34653 29505342
Blood parathyroid hormone decreased 19.25 11.59 12 34520 812 29539183
Intentional product use issue 19.23 11.59 13 34519 42485 29497510
Dermatitis exfoliative 19.09 11.59 30 34502 6395 29533600
Biopsy liver abnormal 18.77 11.59 7 34525 148 29539847
Enterovirus infection 18.76 11.59 11 34521 666 29539329
Complications of transplanted kidney 18.56 11.59 23 34509 3931 29536064
Wrong technique in product usage process 18.11 11.59 7 34525 31421 29508574
Hepatosplenomegaly 18.05 11.59 22 34510 3695 29536300
Blood pressure increased 17.93 11.59 37 34495 73766 29466229
Cytomegalovirus test positive 17.84 11.59 21 34511 3402 29536593
Joint swelling 17.78 11.59 19 34513 49611 29490384
Blood immunoglobulin G decreased 17.77 11.59 13 34519 1146 29538849
Rash morbilliform 17.71 11.59 18 34514 2475 29537520
Injection site pain 17.46 11.59 8 34524 32438 29507557
Hepatic steatosis 17.03 11.59 47 34485 14899 29525096
Protein urine present 16.93 11.59 24 34508 4670 29535325
Rash pruritic 16.89 11.59 61 34471 22302 29517693
Culture stool positive 16.49 11.59 7 34525 210 29539785
Lung infiltration 16.47 11.59 40 34492 11739 29528256
Vena cava injury 16.46 11.59 7 34525 211 29539784
Skin exfoliation 16.45 11.59 61 34471 22584 29517411
Bronchopulmonary aspergillosis 16.29 11.59 41 34491 12303 29527692
Arthralgia 16.25 11.59 96 34436 139521 29400474
Lymphadenopathy 16.17 11.59 65 34467 24984 29515011
Myocardial infarction 16.16 11.59 70 34462 110226 29429769
SARS-CoV-2 antibody test positive 16.01 11.59 7 34525 226 29539769
Oesophageal candidiasis 16.00 11.59 21 34511 3800 29536195
Bone marrow failure 15.98 11.59 69 34463 27380 29512615
Drug hypersensitivity 15.77 11.59 135 34397 68271 29471724
Blood potassium increased 15.64 11.59 45 34487 14606 29525389
Blood albumin decreased 15.59 11.59 39 34493 11656 29528339
Cellulitis enterococcal 15.58 11.59 5 34527 66 29539929
Cytomegalovirus chorioretinitis 15.46 11.59 19 34513 3219 29536776
Renal tubular disorder 15.33 11.59 22 34510 4330 29535665
Rectal prolapse 14.99 11.59 7 34525 264 29539731
Leukaemia recurrent 14.99 11.59 13 34519 1464 29538531
Cystitis haemorrhagic 14.93 11.59 23 34509 4819 29535176
Erythema infectiosum 14.90 11.59 6 34526 157 29539838
Suicide attempt 14.69 11.59 11 34521 34099 29505896
Anaemia 14.67 11.59 322 34210 200629 29339366
Lymphocytic infiltration 14.61 11.59 9 34523 596 29539399
Blood culture positive 14.48 11.59 22 34510 4555 29535440
HIV wasting syndrome 14.26 11.59 5 34527 88 29539907
Traumatic liver injury 14.26 11.59 6 34526 176 29539819
Acute graft versus host disease in skin 14.17 11.59 22 34510 4642 29535353
Somnolence 14.15 11.59 59 34473 93896 29446099
Mental status changes 14.04 11.59 79 34453 34848 29505147
Cystic lymphangioma 13.97 11.59 3 34529 6 29539989
Phlebitis 13.97 11.59 19 34513 3557 29536438
Light chain analysis decreased 13.85 11.59 4 34528 36 29539959
Immunosuppressant drug level increased 13.81 11.59 22 34510 4743 29535252
Mycobacterium avium complex infection 13.66 11.59 15 34517 2254 29537741
Wound evisceration 13.57 11.59 5 34527 102 29539893
Intraductal papillary mucinous neoplasm 13.49 11.59 7 34525 333 29539662
Hepatitis A antibody positive 13.47 11.59 4 34528 40 29539955
Liver transplant 13.41 11.59 15 34517 2301 29537694
Febrile neutropenia 13.21 11.59 194 34338 112046 29427949
Cytomegalovirus test 13.13 11.59 4 34528 44 29539951
Eosinophilia 13.12 11.59 56 34476 22105 29517890
Psoriasis 13.11 11.59 11 34521 32216 29507779
Lymphopenia 12.96 11.59 40 34492 13493 29526502
Autoimmune haemolytic anaemia 12.89 11.59 19 34513 3829 29536166
Blood bilirubin unconjugated increased 12.70 11.59 8 34524 551 29539444
Thrombotic microangiopathy 12.70 11.59 30 34502 8651 29531344
Stent removal 12.65 11.59 3 34529 11 29539984
Therapeutic product effect prolonged 12.64 11.59 6 34526 235 29539760
Feeling abnormal 12.63 11.59 28 34504 54417 29485578
Enterococcal infection 12.56 11.59 29 34503 8239 29531756
Idiopathic pneumonia syndrome 12.52 11.59 6 34526 240 29539755
Hypercalcaemia 12.49 11.59 38 34494 12721 29527274
Total lung capacity decreased 12.48 11.59 8 34524 568 29539427
Hepatitis B antibody positive 12.45 11.59 4 34528 53 29539942
Renal cyst haemorrhage 12.34 11.59 7 34525 398 29539597
Abdominal wall haemorrhage 12.30 11.59 6 34526 250 29539745
Contusion 12.18 11.59 11 34521 31084 29508911
Chills 12.13 11.59 132 34400 71168 29468827
Acute graft versus host disease in liver 12.03 11.59 11 34521 1327 29538668
Granulomatous rosacea 11.97 11.59 5 34527 144 29539851
Transplant dysfunction 11.95 11.59 14 34518 2256 29537739
Haematocrit decreased 11.90 11.59 66 34466 28956 29511039
Pyelonephritis acute 11.67 11.59 12 34520 1672 29538323
Hepatitis C virus test 11.64 11.59 4 34528 66 29539929

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
Muscle injury 886.61 11.17 482 72901 25955 64399394
Folliculitis 839.17 11.17 486 72897 29591 64395758
Sleep disorder due to general medical condition, insomnia type 804.11 11.17 451 72932 25819 64399530
Irritable bowel syndrome 759.06 11.17 493 72890 36876 64388473
Impaired healing 551.83 11.17 495 72888 59978 64365371
Duodenal ulcer perforation 516.94 11.17 378 73005 34247 64391102
Helicobacter infection 493.28 11.17 383 73000 37979 64387370
Blister 482.06 11.17 525 72858 80442 64344907
Gastrointestinal disorder 441.41 11.17 527 72856 89182 64336167
Stomatitis 401.11 11.17 556 72827 109049 64316300
Lower respiratory tract infection 381.21 11.17 503 72880 94111 64331238
Ill-defined disorder 375.13 11.17 347 73036 43705 64381644
Anti-cyclic citrullinated peptide antibody positive 371.85 11.17 364 73019 49198 64376151
Pericarditis 347.18 11.17 391 72992 62125 64363224
Pemphigus 330.87 11.17 376 73007 60325 64365024
Hand deformity 315.62 11.17 373 73010 62398 64362951
Glossodynia 311.43 11.17 376 73007 64320 64361029
Synovitis 308.90 11.17 466 72917 98624 64326725
Pyrexia 300.75 11.17 1343 72040 557301 63868048
Infection 281.51 11.17 638 72745 184242 64241107
Discomfort 278.98 11.17 399 72984 80479 64344870
Sinusitis 275.80 11.17 550 72833 145378 64279971
Systemic lupus erythematosus 273.77 11.17 387 72996 77225 64348124
Therapeutic product effect decreased 273.22 11.17 479 72904 114872 64310477
Hypersensitivity 232.04 11.17 615 72768 195837 64229512
Wound 230.25 11.17 354 73029 76123 64349226
Arthropathy 228.58 11.17 456 72927 120511 64304838
Swelling 223.08 11.17 534 72849 159684 64265665
Hepatic enzyme increased 207.24 11.17 457 72926 129486 64295863
Completed suicide 201.08 11.17 14 73369 224400 64200949
Death 191.67 11.17 161 73222 482544 63942805
Contraindicated product administered 183.07 11.17 389 72994 107440 64317909
Confusional state 176.99 11.17 675 72708 260469 64164880
Rash 162.90 11.17 983 72400 457566 63967783
Contusion 158.68 11.17 380 73003 113585 64311764
Infusion related reaction 155.18 11.17 475 72908 163992 64261357
Fall 154.62 11.17 148 73235 416678 64008671
Nasopharyngitis 151.49 11.17 529 72854 195544 64229805
Product dose omission issue 149.03 11.17 22 73361 194725 64230624
Joint swelling 142.78 11.17 553 72830 214829 64210520
Peripheral swelling 141.92 11.17 541 72842 208612 64216737
Weight increased 139.98 11.17 546 72837 212802 64212547
Off label use 135.95 11.17 327 73056 632479 63792870
Toxicity to various agents 133.68 11.17 130 73253 363383 64061966
Pre-engraftment immune reaction 132.03 11.17 37 73346 304 64425045
Abdominal discomfort 130.65 11.17 480 72903 181842 64243507
Pruritus 122.58 11.17 688 72695 311712 64113637
Drug abuse 122.27 11.17 7 73376 132367 64292982
Drug intolerance 120.76 11.17 478 72905 187514 64237835
Alanine aminotransferase abnormal 113.73 11.17 80 73303 6808 64418541
Dizziness 101.42 11.17 211 73172 429952 63995397
Alopecia 96.64 11.17 409 72974 165281 64260068
Encephalitis viral 95.61 11.17 49 73334 2331 64423018
Red blood cell sedimentation rate 92.96 11.17 56 73327 3658 64421691
Enthesopathy 91.97 11.17 81 73302 9557 64415792
Tongue disorder 89.18 11.17 88 73295 11992 64413357
Injection site pain 86.56 11.17 12 73371 111396 64313953
Malaise 86.28 11.17 203 73180 396044 64029305
Rheumatoid arthritis 84.77 11.17 391 72992 163903 64261446
Cytomegalovirus infection 82.20 11.17 150 73233 37049 64388300
Tenosynovitis 81.47 11.17 83 73300 11750 64413599
Human herpesvirus 6 infection 76.71 11.17 54 73329 4600 64420749
Blood creatinine increased 73.65 11.17 328 73055 135454 64289895
Kidney transplant rejection 73.41 11.17 71 73312 9440 64415909
Intentional overdose 71.51 11.17 9 73374 89935 64335414
Alanine aminotransferase increased 70.31 11.17 329 73054 138702 64286647
Pain in extremity 70.23 11.17 150 73233 302935 64122414
Blood pressure increased 70.21 11.17 56 73327 172496 64252853
Aspartate aminotransferase increased 67.72 11.17 293 73090 119495 64305854
Inappropriate schedule of product administration 67.03 11.17 12 73371 92274 64333075
Blood parathyroid hormone decreased 66.50 11.17 60 73323 7306 64418043
Immune reconstitution inflammatory syndrome 65.77 11.17 76 73307 12394 64412955
Stevens-Johnson syndrome 64.45 11.17 129 73254 34120 64391229
Feeling abnormal 64.24 11.17 36 73347 133566 64291783
Transplant rejection 63.11 11.17 88 73295 17313 64408036
Panniculitis 62.44 11.17 63 73320 8816 64416533
Hyperkalaemia 61.54 11.17 253 73130 100876 64324473
Wrong technique in product usage process 58.29 11.17 4 73379 64970 64360379
Pregnancy 56.40 11.17 92 73291 20773 64404576
Intentional product misuse 55.65 11.17 8 73375 72287 64353062
Tendonitis 55.60 11.17 90 73293 20192 64405157
Fear of injection 55.04 11.17 49 73334 5863 64419486
Therapeutic product effect incomplete 54.06 11.17 25 73358 103457 64321892
Maternal exposure during pregnancy 53.77 11.17 234 73149 95650 64329699
Clear cell renal cell carcinoma 52.34 11.17 32 73351 2147 64423202
Granuloma skin 48.12 11.17 46 73337 6028 64419321
Back pain 47.60 11.17 137 73246 250034 64175315
Skin necrosis 46.87 11.17 69 73314 14260 64411089
Headache 46.73 11.17 382 73001 529085 63896264
Therapy non-responder 46.69 11.17 173 73210 65726 64359623
Syncope 46.46 11.17 67 73316 157568 64267781
Lymphoproliferative disorder 44.96 11.17 41 73342 5062 64420287
Cough 44.94 11.17 184 73199 301964 64123385
Pancytopenia 43.68 11.17 296 73087 143013 64282336
Drug hypersensitivity 43.26 11.17 437 72946 237378 64187971
Rheumatoid nodule 42.95 11.17 62 73321 12589 64412760
Psoriasis 42.94 11.17 14 73369 71689 64353660
Cerebrovascular accident 41.02 11.17 58 73325 137525 64287824
Diarrhoea 40.58 11.17 579 72804 722125 63703224
Maternal exposure timing unspecified 39.11 11.17 29 73354 2678 64422671
Suicide attempt 38.91 11.17 16 73367 70991 64354358
Nausea 38.55 11.17 646 72737 785154 63640195
Myocardial infarction 38.41 11.17 82 73301 165739 64259610
Gait disturbance 38.35 11.17 87 73296 172068 64253281
Hepatic cytolysis 38.04 11.17 62 73321 13987 64411362
Renal tubular necrosis 37.73 11.17 80 73303 22030 64403319
Injection site erythema 37.13 11.17 17 73366 70783 64354566
Balance disorder 37.02 11.17 25 73358 83901 64341448
Overdose 36.88 11.17 79 73304 159487 64265862
Cytomegalovirus viraemia 36.66 11.17 53 73330 10775 64414574
Oropharyngeal pain 35.93 11.17 29 73354 88838 64336511
Weight decreased 35.37 11.17 186 73197 285553 64139796
Condition aggravated 34.52 11.17 265 73118 372161 64053188
Blood urea increased 33.90 11.17 119 73264 44034 64381315
Nasal congestion 33.41 11.17 13 73370 59645 64365704
C-reactive protein abnormal 33.24 11.17 90 73293 28957 64396392
Rhinorrhoea 32.08 11.17 14 73369 59955 64365394
Constipation 32.02 11.17 143 73240 229194 64196155
Cardio-respiratory arrest 31.86 11.17 39 73344 98354 64326995
Drug eruption 31.82 11.17 102 73281 36034 64389315
Hypertension 31.40 11.17 170 73213 259091 64166258
Hospitalisation 31.08 11.17 24 73359 75183 64350166
Pneumocystis jirovecii pneumonia 31.00 11.17 85 73298 27549 64397800
Memory impairment 31.00 11.17 31 73352 85651 64339698
Incision site pain 30.87 11.17 25 73358 2629 64422720
Haemodialysis 30.55 11.17 63 73320 17014 64408335
Depressed mood 30.51 11.17 5 73378 41007 64384342
Pneumonia 30.40 11.17 451 72932 559125 63866224
Meningoencephalitis herpetic 30.35 11.17 21 73362 1740 64423609
Complications of transplanted kidney 30.14 11.17 34 73349 5401 64419948
Loss of consciousness 29.87 11.17 79 73304 148286 64277063
Asthma 29.53 11.17 39 73344 95186 64330163
Fluid retention 28.73 11.17 16 73367 59590 64365759
Multiple sclerosis relapse 28.49 11.17 6 73377 41129 64384220
Muscle spasms 28.46 11.17 75 73308 140948 64284401
Depression 28.24 11.17 110 73273 183181 64242168
Injection site reaction 28.13 11.17 9 73374 46655 64378694
Haematochezia 27.66 11.17 21 73362 66352 64358997
Agranulocytosis 27.61 11.17 101 73282 38128 64387221
Cardiac failure congestive 27.47 11.17 68 73315 130512 64294837
Hypotension 27.45 11.17 289 73094 380685 64044664
Drug reaction with eosinophilia and systemic symptoms 27.15 11.17 128 73255 54089 64371260
Influenza 26.97 11.17 50 73333 106481 64318868
Febrile bone marrow aplasia 26.93 11.17 47 73336 11208 64414141
Product prescribing error 26.91 11.17 4 73379 35265 64390084
Serotonin syndrome 26.66 11.17 6 73377 39276 64386073
COVID-19 26.65 11.17 21 73362 65119 64360230
Visual impairment 26.57 11.17 27 73356 74050 64351299
Drug ineffective 26.54 11.17 741 72642 839506 63585843
Suicidal ideation 26.54 11.17 22 73361 66520 64358829
Liver transplant rejection 26.23 11.17 24 73359 2975 64422374
Granuloma 26.22 11.17 35 73348 6606 64418743
Cardiac failure 25.51 11.17 72 73311 132301 64293048
Stress 25.42 11.17 19 73364 60515 64364834
Blood lactate dehydrogenase increased 25.26 11.17 89 73294 32989 64392360
Haematemesis 25.09 11.17 11 73372 46988 64378361
Anxiety 25.01 11.17 132 73251 202517 64222832
Sedation 24.99 11.17 8 73375 41454 64383895
Cytomegalovirus test positive 24.89 11.17 30 73353 5114 64420235
Injection site swelling 24.89 11.17 8 73375 41345 64384004
Palpitations 24.75 11.17 51 73332 104437 64320912
Drug interaction 24.35 11.17 279 73104 361804 64063545
Ulcer 24.10 11.17 69 73314 22921 64402428
Arthralgia 23.51 11.17 664 72719 441596 63983753
Chest discomfort 23.24 11.17 62 73321 116044 64309305
Chronic obstructive pulmonary disease 23.17 11.17 28 73355 71020 64354329
Serum sickness 23.11 11.17 23 73360 3166 64422183
Breast cancer 22.96 11.17 3 73380 29145 64396204
Deep vein thrombosis postoperative 22.81 11.17 16 73367 1355 64423994
Flushing 22.60 11.17 34 73349 78614 64346735
Neck pain 22.56 11.17 22 73361 61511 64363838
Atrial fibrillation 22.50 11.17 109 73274 170980 64254369
Unevaluable event 22.32 11.17 15 73368 50474 64374875
Dyspepsia 21.86 11.17 36 73347 80276 64345073
Hypercalcaemia 21.85 11.17 82 73301 31334 64394015
Blood pressure fluctuation 20.87 11.17 17 73366 51854 64373495
Rash pruritic 20.83 11.17 124 73259 57280 64368069
Bronchopulmonary aspergillosis 20.71 11.17 58 73325 19027 64406322
Intentional self-injury 20.60 11.17 4 73379 29040 64396309
Paraesthesia 20.55 11.17 81 73302 134441 64290908
Delayed graft function 20.36 11.17 21 73362 3015 64422334
Lymphocyte count decreased 20.32 11.17 96 73287 40603 64384746
Osteonecrosis of jaw 20.21 11.17 10 73373 39815 64385534
Hot flush 20.08 11.17 14 73369 46221 64379128
Liver transplant 20.02 11.17 24 73359 4068 64421281
Cardiogenic shock 20.00 11.17 6 73377 32421 64392928
Hyperhidrosis 19.86 11.17 74 73309 124846 64300503
Pain in jaw 19.55 11.17 11 73372 40744 64384605
Platelet count decreased 19.42 11.17 283 73100 167428 64257921
Basal cell carcinoma 19.41 11.17 78 73305 30760 64394589
Wheezing 19.36 11.17 39 73344 80540 64344809
Somnolence 19.26 11.17 144 73239 203501 64221848
Cataract 19.17 11.17 18 73365 51244 64374105
Blood antidiuretic hormone increased 19.15 11.17 6 73377 75 64425274
Blood culture positive 19.01 11.17 33 73350 7835 64417514
Plasma cell myeloma 19.01 11.17 103 73280 45972 64379377
Asthenia 18.95 11.17 358 73025 427686 63997663
Dialysis 18.93 11.17 52 73331 16868 64408481
Limb discomfort 18.74 11.17 4 73379 27171 64398178
Injection site pruritus 18.45 11.17 10 73373 37816 64387533
Renal tubular disorder 18.40 11.17 28 73355 5959 64419390
Blood bilirubin unconjugated increased 18.35 11.17 12 73371 905 64424444
Acute myocardial infarction 18.29 11.17 32 73351 69686 64355663
Cardiac disorder 18.20 11.17 22 73361 55794 64369555
Sphincter of Oddi dysfunction 18.17 11.17 9 73374 398 64424951
Bradycardia 18.17 11.17 71 73312 118148 64307201
Cardiac arrest 18.10 11.17 102 73281 153962 64271387
Incorrect dose administered 17.72 11.17 26 73357 60739 64364610
Autoimmune disorder 17.59 11.17 27 73356 5789 64419560
Diabetic ketoacidosis 17.56 11.17 6 73377 29839 64395510
Product quality issue 17.52 11.17 6 73377 29793 64395556
Biopsy liver abnormal 17.43 11.17 9 73374 435 64424914
Influenza like illness 17.42 11.17 27 73356 61675 64363674
Abdominal pain upper 17.40 11.17 122 73261 174908 64250441
Muscular weakness 17.40 11.17 80 73303 127258 64298091
Musculoskeletal pain 17.35 11.17 42 73341 81252 64344097
Acute kidney injury 17.25 11.17 649 72734 448591 63976758
Psychotic disorder 17.07 11.17 9 73374 34569 64390780
Graft versus host disease 17.02 11.17 44 73339 13769 64411580
Aspergillus infection 17.01 11.17 49 73334 16330 64409019
Perinephric collection 17.01 11.17 8 73375 315 64425034
Cytomegalovirus test 16.97 11.17 5 73378 50 64425299
Cephalhaematoma 16.90 11.17 4 73379 15 64425334
Ischaemic stroke 16.81 11.17 6 73377 29029 64396320
Red blood cells urine positive 16.76 11.17 23 73360 4455 64420894
Rash maculo-papular 16.69 11.17 101 73282 46925 64378424
Osteoporosis 16.67 11.17 14 73369 42066 64383283
Dyspnoea exertional 16.62 11.17 37 73346 73693 64351656
Toxic skin eruption 16.58 11.17 54 73329 19230 64406119
Culture urine positive 16.58 11.17 22 73361 4129 64421220
Dysphonia 16.52 11.17 17 73366 46365 64378984
Acquired immunodeficiency syndrome 16.45 11.17 7 73376 217 64425132
Gastrointestinal haemorrhage 16.42 11.17 86 73297 132226 64293123
Aggression 16.41 11.17 17 73366 46215 64379134
Anaphylactic shock 16.34 11.17 7 73376 30321 64395028
Vena cava injury 16.27 11.17 7 73376 223 64425126
Migraine 16.23 11.17 29 73354 62648 64362701
Autoimmune haemolytic anaemia 16.22 11.17 29 73354 7047 64418302
Dermatitis exfoliative 16.00 11.17 36 73347 10316 64415033
Drug dependence 15.97 11.17 9 73374 33303 64392046
Chronic lymphocytic leukaemia 15.91 11.17 22 73361 4293 64421056
Blood bilirubin increased 15.83 11.17 116 73267 57437 64367912
HIV wasting syndrome 15.78 11.17 5 73378 65 64425284
Lung infiltration 15.77 11.17 56 73327 20833 64404516
SARS-CoV-2 antibody test positive 15.73 11.17 7 73376 242 64425107
Labelled drug-drug interaction medication error 15.73 11.17 3 73380 22059 64403290
Poisoning 15.55 11.17 3 73380 21876 64403473
Enterovirus infection 15.43 11.17 13 73370 1444 64423905
Culture stool positive 15.43 11.17 9 73374 554 64424795
Hypothyroidism 15.37 11.17 14 73369 40443 64384906
Delirium 15.37 11.17 35 73348 69159 64356190
Heart rate increased 15.33 11.17 59 73324 98616 64326733
Withdrawal syndrome 15.13 11.17 4 73379 23488 64401861
Vomiting 15.11 11.17 495 72888 550622 63874727
Thrombocytopenia 15.09 11.17 347 73036 223454 64201895
Tumour flare 15.03 11.17 10 73373 777 64424572
Cystitis haemorrhagic 15.00 11.17 30 73353 7926 64417423
Osteoarthritis 14.92 11.17 31 73352 63305 64362044
Neuroleptic malignant syndrome 14.75 11.17 5 73378 24991 64400358
Hepatitis fulminant 14.75 11.17 26 73357 6248 64419101
Acne 14.74 11.17 4 73379 23077 64402272
Cerebral infarction 14.67 11.17 15 73368 41029 64384320
Melaena 14.58 11.17 24 73359 53524 64371825
Urinary tract infection 14.57 11.17 181 73202 231415 64193934
Neutropenia 14.48 11.17 366 73017 239258 64186091
Surgery 14.44 11.17 7 73376 28206 64397143
Full blood count abnormal 14.32 11.17 8 73375 29749 64395600
Tooth disorder 14.08 11.17 4 73379 22398 64402951
Femur fracture 13.97 11.17 11 73372 34124 64391225
Toxic epidermal necrolysis 13.95 11.17 81 73302 37085 64388264
Aplasia pure red cell 13.89 11.17 27 73356 6987 64418362
Oral pain 13.81 11.17 7 73376 27486 64397863
Heart rate decreased 13.79 11.17 26 73357 55041 64370308
Thrombotic microangiopathy 13.75 11.17 46 73337 16609 64408740
Heart rate irregular 13.73 11.17 7 73376 27406 64397943
Tarsal tunnel syndrome 13.64 11.17 8 73375 497 64424852
Granulomatous rosacea 13.61 11.17 6 73377 203 64425146
Blood alkaline phosphatase increased 13.57 11.17 110 73273 56169 64369180
Purpura senile 13.56 11.17 8 73375 503 64424846
Pulmonary arterial hypertension 13.44 11.17 6 73377 25361 64399988
Chemotherapeutic drug level increased 13.43 11.17 7 73376 345 64425004
Hepatomegaly 13.39 11.17 46 73337 16836 64408513
Tubulointerstitial nephritis 13.36 11.17 70 73313 30839 64394510
Epistaxis 13.20 11.17 62 73321 98069 64327280
Complications of transplant surgery 13.18 11.17 9 73374 730 64424619
Oxygen saturation decreased 13.11 11.17 70 73313 107106 64318243
Depressed level of consciousness 13.10 11.17 48 73335 81388 64343961
HIV infection 13.04 11.17 10 73373 972 64424377
Enterococcal infection 13.00 11.17 40 73343 13826 64411523
Leukopenia 12.99 11.17 174 73209 101068 64324281
Dysphagia 12.93 11.17 70 73313 106742 64318607
Speech disorder 12.92 11.17 22 73361 48419 64376930
Chest pain 12.83 11.17 190 73193 235790 64189559
Wound evisceration 12.79 11.17 5 73378 124 64425225
Vision blurred 12.78 11.17 56 73327 90260 64335089
Injury 12.73 11.17 108 73275 55884 64369465
Fracture 12.46 11.17 3 73380 18752 64406597
Respiratory arrest 12.43 11.17 26 73357 52959 64372390
Hepatosplenomegaly 12.38 11.17 22 73361 5321 64420028
Renal failure 12.33 11.17 282 73101 181406 64243943
Deafness transitory 12.30 11.17 9 73374 814 64424535
Lymphocele 12.19 11.17 12 73371 1629 64423720
Frequent bowel movements 12.02 11.17 3 73380 18302 64407047
Mental status changes 11.87 11.17 114 73269 61048 64364301
Lymphocytic infiltration 11.82 11.17 11 73372 1393 64423956
Psoriatic arthropathy 11.77 11.17 87 73296 43194 64382155
Clostridial infection 11.76 11.17 21 73362 5098 64420251
Trimethylaminuria 11.72 11.17 5 73378 156 64425193
Transfusion 11.71 11.17 3 73380 17991 64407358
Bronchitis 11.71 11.17 74 73309 108669 64316680
Rash morbilliform 11.69 11.17 21 73362 5120 64420229
Pneumonia fungal 11.69 11.17 29 73354 8848 64416501
Renal cyst haemorrhage 11.65 11.17 7 73376 455 64424894
Throat irritation 11.64 11.17 12 73371 32699 64392650
Arrhythmia 11.58 11.17 27 73356 52917 64372432
Drug ineffective for unapproved indication 11.56 11.17 11 73372 31122 64394227
Lung neoplasm malignant 11.48 11.17 5 73378 21443 64403906
Electrocardiogram QT prolonged 11.40 11.17 49 73334 79399 64345950
Pain 11.27 11.17 752 72631 552759 63872590
Acute graft versus host disease 11.26 11.17 29 73354 9055 64416294
Device dislocation 11.24 11.17 5 73378 21173 64404176
Agitation 11.21 11.17 57 73326 88310 64337039
Hepatitis C virus test 11.17 11.17 4 73379 77 64425272

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
CHEBI has role CHEBI:33281 antibiotics
CHEBI has role CHEBI:33282 bactericides
CHEBI has role CHEBI:35441 antiinfective agents
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:50183 P450 inhibitors
CHEBI has role CHEBI:50502 dihydropteroate synthase inhibitors
CHEBI has role CHEBI:53000 epitope role
CHEBI has role CHEBI:74234 sepiapterin reductase inhibitors
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:88188 allergenic drug
FDA MoA N0000185504 Cytochrome P450 2C9 Inhibitors

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

DiseaseRelationSNOMED_IDDOID
Acute otitis media indication 3110003
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
Streptococcus Pneumoniae Chronic Bronchitis indication
Haemophilus Influenzae Chronic Bronchitis indication
Aerobic Gram-Positive Cocci Infection indication
Pneumocystis Carinii Pneumonia Prevention indication
Aerobic Gram-Negative Bacillary Infection indication
Haemophilus Influenzae Acute Otitis Media indication
Morganella Morganii Urinary Tract Infection 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
Chronic Bacterial Prostatitis off-label use
Toxoplasmosis Prevention off-label use
Postexposure Plague Prophylaxis off-label use
Diabetic Foot Infection 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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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 28 sections
SULFATRIM HUMAN PRESCRIPTION DRUG LABEL 2 0121-0854 SUSPENSION 200 mg ORAL NDA 28 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0121-4793 SUSPENSION 200 mg ORAL ANDA 28 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 0527-5180 SUSPENSION 200 mg ORAL ANDA 21 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0527-5181 SUSPENSION 200 mg ORAL ANDA 21 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 22 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0703-9514 INJECTION, SOLUTION, CONCENTRATE 80 mg INTRAVENOUS ANDA 22 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0703-9514 INJECTION, SOLUTION, CONCENTRATE 80 mg INTRAVENOUS ANDA 22 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0703-9526 INJECTION, SOLUTION, CONCENTRATE 80 mg INTRAVENOUS ANDA 22 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