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

Stem definitionDrug idCAS RN
antibiotics, produced by Streptomyces strains 276 83905-01-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • CP-62993
  • CP 62993
  • azithromycin
  • arzomicin
  • aziromycin
  • Azithromycin A
  • azithromycin monohydrate
  • azithromycin anhydrous
  • azithromycin dihydrate
  • azithromycin hydrate
A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis. Some evidence of in vitro activity against SARS-CoV-2 in infected Vero E6 and Caco-2 cells has been reported but clinical importance it is unclear. Only limited information available regarding the frequency and microbiology of bacterial pulmonary coinfections or superinfections in pacients with COVID-19.
  • Molecular weight: 749.00
  • Formula: C38H72N2O12
  • CLOGP: 2.64
  • LIPINSKI: 2
  • HAC: 14
  • HDO: 5
  • TPSA: 180.08
  • ALOGS: -3.16
  • ROTB: 7
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.30 g O
0.50 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 39 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 6 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 44.50 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 34 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 33 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 10 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.88 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 69 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 1, 1991 FDA
March 10, 2000 PMDA PFIZER

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 1471.34 9.98 2022 90515 273183 55926347
Infective pulmonary exacerbation of cystic fibrosis 779.69 9.98 342 92195 7815 56191715
Off label use 538.15 9.98 2064 90473 554116 55645414
Abortion incomplete 537.58 9.98 200 92337 2927 56196603
Rheumatoid arthritis 304.99 9.98 124 92413 382480 55817050
Macular degeneration 271.70 9.98 235 92302 18673 56180857
Asthma 271.23 9.98 583 91954 112187 56087343
Cystic fibrosis 270.67 9.98 126 92411 3318 56196212
Contraindicated product administered 246.45 9.98 15 92522 186271 56013259
Abortion spontaneous 235.93 9.98 324 92213 43429 56156101
Joint swelling 235.56 9.98 91 92446 289709 55909821
Electrocardiogram QT prolonged 207.00 9.98 343 92194 54245 56145285
Synovitis 201.80 9.98 17 92520 161288 56038242
Hand deformity 201.29 9.98 4 92533 134488 56065042
Wheezing 180.41 9.98 388 92149 74638 56124892
Systemic lupus erythematosus 180.38 9.98 38 92499 180040 56019490
Arthropathy 174.43 9.98 56 92481 200219 55999311
Completed suicide 173.33 9.98 12 92525 133821 56065709
Premature delivery 173.13 9.98 218 92319 26842 56172688
Glossodynia 165.98 9.98 26 92511 152432 56047098
Cholecystitis chronic 164.56 9.98 133 92404 9615 56189915
Cough 162.82 9.98 850 91687 259111 55940419
Therapeutic product effect decreased 157.40 9.98 42 92495 169410 56030120
Exposure during pregnancy 156.88 9.98 537 92000 135805 56063725
Haemorrhage 151.16 9.98 305 92232 56092 56143438
Arthralgia 147.46 9.98 385 92152 501284 55698246
Bronchiectasis 142.21 9.98 131 92406 11303 56188227
Alopecia 140.94 9.98 165 92372 293293 55906237
No adverse event 138.45 9.98 229 92308 36145 56163385
Pneumonia 132.87 9.98 1131 91406 405967 55793563
Product use in unapproved indication 127.13 9.98 513 92024 140309 56059221
Product packaging quantity issue 126.10 9.98 54 92483 1160 56198370
Wound 124.06 9.98 37 92500 138767 56060763
Productive cough 120.73 9.98 278 92259 55954 56143576
COVID-19 120.24 9.98 332 92205 74726 56124804
Infusion related reaction 119.16 9.98 101 92436 208830 55990700
Pericarditis 115.35 9.98 20 92517 108903 56090627
Injury 113.51 9.98 282 92255 59569 56139961
Emotional distress 112.76 9.98 187 92350 29576 56169954
Sputum discoloured 110.86 9.98 127 92410 14165 56185365
Swelling 106.51 9.98 143 92394 239628 55959902
Sleep disorder due to a general medical condition 101.29 9.98 98 92439 8992 56190538
Hepatic enzyme increased 98.74 9.98 82 92455 171302 56028228
Upper respiratory tract infection 98.43 9.98 299 92238 70989 56128541
Helicobacter infection 96.52 9.98 6 92531 73262 56126268
Treatment failure 95.15 9.98 84 92453 170308 56029222
Drug intolerance 88.96 9.98 189 92348 264629 55934901
Bronchitis 88.77 9.98 393 92144 111918 56087612
Haemoptysis 86.38 9.98 156 92381 26404 56173126
Drug ineffective for unapproved indication 84.95 9.98 152 92385 25541 56173989
Pulmonary function test decreased 82.74 9.98 59 92478 3532 56195998
Mycobacterium avium complex infection 82.38 9.98 54 92483 2815 56196715
Nasal polyps 80.70 9.98 56 92481 3209 56196321
Long QT syndrome 78.96 9.98 54 92483 3022 56196508
Normal labour 76.91 9.98 22 92515 129 56199401
Discomfort 76.61 9.98 72 92465 141689 56057841
Pulmonary embolism 75.87 9.98 363 92174 106761 56092769
Biliary dyskinesia 75.45 9.98 49 92488 2514 56197016
Abdominal discomfort 73.68 9.98 223 92314 277051 55922479
Muscle injury 73.26 9.98 3 92534 52497 56147033
Anosmia 71.86 9.98 59 92478 4360 56195170
Rhinitis allergic 70.32 9.98 78 92459 8396 56191134
Fatigue 68.40 9.98 901 91636 787651 55411879
Folliculitis 68.14 9.98 6 92531 54973 56144557
Asthma-chronic obstructive pulmonary disease overlap syndrome 68.13 9.98 30 92507 691 56198839
Hypoxia 67.87 9.98 219 92318 53678 56145852
Impaired healing 67.60 9.98 29 92508 86812 56112718
Mobility decreased 66.68 9.98 40 92497 98951 56100579
Infective exacerbation of bronchiectasis 66.59 9.98 24 92513 319 56199211
Peripheral swelling 66.57 9.98 183 92354 234543 55964987
Drug interaction 66.21 9.98 579 91958 209176 55990354
Delivery 65.16 9.98 31 92506 858 56198672
Deafness 64.31 9.98 105 92432 16389 56183141
Intentional overdose 62.98 9.98 17 92520 68100 56131430
Respiratory failure 62.92 9.98 316 92221 94746 56104784
Cystic fibrosis respiratory infection suppression 59.40 9.98 21 92516 263 56199267
Chronic obstructive pulmonary disease 58.96 9.98 218 92319 57197 56142333
Eosinophilic pneumonia 58.70 9.98 38 92499 1939 56197591
Pathogen resistance 58.21 9.98 60 92477 5940 56193590
Torsade de pointes 56.57 9.98 85 92452 12355 56187175
Product dose omission issue 55.93 9.98 548 91989 204205 55995325
Sleep disorder due to general medical condition, insomnia type 55.75 9.98 4 92533 43334 56156196
Fall 55.06 9.98 353 92184 357157 55842373
Rales 55.00 9.98 78 92459 10762 56188768
Product quality issue 54.42 9.98 144 92393 31592 56167938
Total lung capacity increased 54.14 9.98 28 92509 931 56198599
Obstructive airways disorder 53.03 9.98 99 92438 17183 56182347
Factor V inhibition 52.54 9.98 17 92520 159 56199371
Toxicity to various agents 52.47 9.98 191 92346 224373 55975157
Dyspnoea 52.22 9.98 1308 91229 591269 55608261
Chronic kidney disease 52.15 9.98 170 92367 41886 56157644
Cholelithiasis 52.10 9.98 163 92374 39301 56160229
Drug abuse 51.95 9.98 23 92514 67587 56131943
Stevens-Johnson syndrome 51.91 9.98 115 92422 22548 56176982
Musculoskeletal stiffness 51.78 9.98 112 92425 155895 56043635
Gallbladder disorder 51.58 9.98 98 92439 17236 56182294
Acute generalised exanthematous pustulosis 51.54 9.98 72 92465 9797 56189733
Death 49.11 9.98 344 92193 341082 55858448
Forced expiratory volume decreased 47.76 9.98 48 92489 4612 56194918
Full blood count abnormal 47.35 9.98 122 92415 26340 56173190
Respiratory tract infection 46.71 9.98 148 92389 35923 56163607
Eosinophilia 46.12 9.98 102 92435 19975 56179555
Blister 45.25 9.98 68 92469 108819 56090711
Malignant neoplasm progression 43.86 9.98 34 92503 73553 56125977
Chest discomfort 43.50 9.98 295 92242 98562 56100968
Product use issue 41.00 9.98 162 92375 185879 56013651
Drug-induced liver injury 40.67 9.98 137 92400 34325 56165205
Tinnitus 40.50 9.98 125 92412 29917 56169613
Irritable bowel syndrome 40.33 9.98 32 92505 68426 56131104
Drug reaction with eosinophilia and systemic symptoms 39.84 9.98 125 92412 30179 56169351
Symmetrical drug-related intertriginous and flexural exanthema 39.66 9.98 17 92520 366 56199164
Lung opacity 39.63 9.98 32 92505 2309 56197221
Maternal exposure during pregnancy 39.58 9.98 481 92056 189072 56010458
Low birth weight baby 39.35 9.98 50 92487 6208 56193322
Prolonged expiration 39.28 9.98 22 92515 860 56198670
Heart sounds 38.72 9.98 21 92516 770 56198760
Eosinophil count increased 38.45 9.98 62 92475 9575 56189955
Stomatitis 38.23 9.98 89 92448 120721 56078809
Alveolitis 37.94 9.98 33 92504 2640 56196890
Auscultation 37.89 9.98 7 92530 0 56199530
Pseudomonas infection 37.76 9.98 63 92474 10008 56189522
Breath sounds abnormal 37.38 9.98 59 92478 8948 56190582
Confusional state 37.08 9.98 196 92341 207959 55991571
Dysbiosis 36.79 9.98 20 92517 737 56198793
Kounis syndrome 36.22 9.98 24 92513 1274 56198256
Lip oedema 35.96 9.98 36 92501 3442 56196088
Suicide attempt 35.39 9.98 26 92511 57810 56141720
Respiration abnormal 35.36 9.98 45 92492 5596 56193934
Bronchopulmonary aspergillosis allergic 33.87 9.98 24 92513 1422 56198108
Chronic sinusitis 33.56 9.98 54 92483 8324 56191206
Rheumatic fever 33.51 9.98 4 92533 28823 56170707
Drug resistance 33.00 9.98 91 92446 20451 56179079
Sinusitis 32.80 9.98 481 92056 197100 56002430
Deep vein thrombosis 32.25 9.98 227 92310 76750 56122780
Acute respiratory distress syndrome 32.17 9.98 94 92443 21832 56177698
Psoriatic arthropathy 31.94 9.98 45 92492 73963 56125567
Sputum increased 31.72 9.98 27 92510 2097 56197433
Ventricular fibrillation 31.45 9.98 61 92476 10891 56188639
Knee arthroplasty 31.06 9.98 17 92520 44242 56155288
Total lung capacity decreased 30.98 9.98 23 92514 1466 56198064
Cystic fibrosis pancreatic 30.61 9.98 9 92528 59 56199471
Myasthenia gravis crisis 30.42 9.98 15 92522 450 56199080
Congenital absence of cranial vault 30.22 9.98 7 92530 14 56199516
Bronchopulmonary aspergillosis 30.06 9.98 51 92486 8213 56191317
Pelvic inflammatory disease 30.01 9.98 23 92514 1538 56197992
Toxic epidermal necrolysis 29.98 9.98 92 92445 21950 56177580
Oropharyngeal pain 29.96 9.98 238 92299 83550 56115980
Middle lobe syndrome 29.90 9.98 8 92529 35 56199495
Hip arthroplasty 29.89 9.98 13 92524 38610 56160920
Flank pain 29.82 9.98 70 92467 14255 56185275
Distal intestinal obstruction syndrome 29.74 9.98 14 92523 378 56199152
COVID-19 pneumonia 29.67 9.98 60 92477 11042 56188488
Overdose 29.59 9.98 83 92454 105747 56093783
Foetal exposure during pregnancy 29.50 9.98 122 92415 33701 56165829
Device expulsion 29.29 9.98 7 92530 30442 56169088
Mixed liver injury 28.83 9.98 34 92503 3910 56195620
Pneumothorax spontaneous 28.63 9.98 17 92520 743 56198787
Pneumothorax 28.11 9.98 70 92467 14797 56184733
Somnolence 27.92 9.98 156 92381 163257 56036273
Bronchial wall thickening 27.82 9.98 19 92518 1061 56198469
C-reactive protein abnormal 27.53 9.98 13 92524 36796 56162734
Anxiety 27.39 9.98 458 92079 192714 56006816
Hallucinations, mixed 27.27 9.98 35 92502 4389 56195141
Gallbladder injury 26.87 9.98 20 92517 1280 56198250
Ototoxicity 26.50 9.98 19 92518 1147 56198383
Pregnancy 26.37 9.98 116 92421 32917 56166613
Joint range of motion decreased 26.10 9.98 5 92532 25360 56174170
Hypersensitivity 25.87 9.98 283 92254 256125 55943405
Mycobacterial infection 25.86 9.98 22 92515 1708 56197822
Pain 25.80 9.98 863 91674 662321 55537209
Amniotic cavity infection 25.76 9.98 19 92518 1199 56198331
Urticaria 25.51 9.98 356 92181 144320 56055210
Gastroenteritis staphylococcal 25.20 9.98 8 92529 70 56199460
Rheumatoid factor 25.20 9.98 8 92529 70 56199460
Cystic fibrosis lung 25.15 9.98 9 92528 117 56199413
Mycobacterium abscessus infection 25.15 9.98 15 92522 661 56198869
Mechanical urticaria 24.98 9.98 13 92524 438 56199092
Pulmonary function test abnormal 24.94 9.98 20 92517 1429 56198101
Agranulocytosis 24.92 9.98 88 92449 22571 56176959
Factor V deficiency 24.80 9.98 8 92529 74 56199456
Abdominal pain 24.69 9.98 578 91959 258227 55941303
Anhedonia 24.64 9.98 52 92485 9862 56189668
Febrile neutropenia 24.47 9.98 90 92447 105455 56094075
Sarcoidosis 24.29 9.98 37 92500 5443 56194087
Blood cholesterol increased 24.15 9.98 52 92485 72527 56127003
Premature baby 24.13 9.98 78 92459 19127 56180403
Gallbladder cholesterolosis 23.96 9.98 15 92522 722 56198808
Ageusia 23.94 9.98 59 92478 12392 56187138
Transaminases increased 23.71 9.98 102 92435 28668 56170862
Obliterative bronchiolitis 23.41 9.98 22 92515 1946 56197584
Stenotrophomonas infection 23.31 9.98 21 92516 1760 56197770
Rhinorrhoea 23.19 9.98 167 92370 56870 56142660
Coma 23.12 9.98 39 92498 59616 56139914
Lung transplant rejection 23.04 9.98 15 92522 773 56198757
Epidermolysis 23.01 9.98 10 92527 223 56199307
Staphylococcus test positive 22.93 9.98 29 92508 3584 56195946
Type 2 diabetes mellitus 22.81 9.98 26 92511 46836 56152694
Neutrophil count decreased 22.81 9.98 29 92508 49793 56149737
Breast cancer 22.80 9.98 28 92509 48805 56150725
Injection site pain 22.71 9.98 107 92430 117011 56082519
Platelet count decreased 22.56 9.98 94 92443 106289 56093241
Sedation 22.20 9.98 15 92522 34839 56164691
Uterine perforation 22.16 9.98 39 92498 6466 56193064
Endometritis 22.15 9.98 16 92521 977 56198553
Respiratory tract congestion 22.07 9.98 66 92471 15525 56184005
Granulomatosis with polyangiitis 22.07 9.98 22 92515 2093 56197437
Influenza 21.75 9.98 246 92291 95015 56104515
Delusional disorder, persecutory type 21.75 9.98 9 92528 177 56199353
Orthostatic hypotension 21.54 9.98 14 92523 33185 56166345
Gastrointestinal disorder 21.25 9.98 104 92433 112598 56086932
Disseminated mycobacterium avium complex infection 21.20 9.98 8 92529 122 56199408
Pneumonia pseudomonal 21.14 9.98 22 92515 2202 56197328
Hospitalisation 21.06 9.98 202 92335 74798 56124732
Oral candidiasis 20.74 9.98 73 92464 18690 56180840
Injection site erythema 20.73 9.98 62 92475 77386 56122144
Pulmonary infarction 20.63 9.98 23 92514 2489 56197041
Atypical mycobacterial infection 20.55 9.98 15 92522 931 56198599
Appetite disorder 20.51 9.98 38 92499 6555 56192975
Neutropenia 20.48 9.98 164 92373 158003 56041527
Hypertension 20.32 9.98 281 92256 243997 55955533
Viral infection 20.28 9.98 105 92432 31841 56167689
Bronchomalacia 20.21 9.98 9 92528 213 56199317
Pneumomediastinum 20.00 9.98 17 92520 1318 56198212
Cystic fibrosis related diabetes 19.95 9.98 6 92531 43 56199487
Osteoarthritis 19.59 9.98 67 92470 80229 56119301
Gait disturbance 19.50 9.98 173 92364 163148 56036382
Blood pressure fluctuation 18.99 9.98 23 92514 40337 56159193
Actinic keratosis 18.83 9.98 21 92516 2274 56197256
Pyrexia 18.64 9.98 854 91683 417919 55781611
Pancreatic failure 18.60 9.98 14 92523 911 56198619
White blood cell count decreased 18.53 9.98 126 92411 125864 56073666
Hypokalaemia 18.47 9.98 86 92451 94351 56105179
Drug effective for unapproved indication 18.42 9.98 22 92515 2564 56196966
Impaired quality of life 18.29 9.98 42 92495 8432 56191098
Hepatocellular injury 18.14 9.98 89 92448 26425 56173105
Gastrointestinal haemorrhage 18.11 9.98 64 92473 75887 56123643
Biliary colic 18.03 9.98 25 92512 3377 56196153
Fibromyalgia 17.98 9.98 45 92492 59558 56139972
Cardiac arrest 17.97 9.98 219 92318 86095 56113435
Joint stiffness 17.96 9.98 19 92518 35406 56164124
Pain in extremity 17.91 9.98 363 92174 297068 55902462
Procedural pain 17.73 9.98 63 92474 16208 56183322
Contusion 17.64 9.98 131 92406 128299 56071231
Vaginal stricture 17.62 9.98 4 92533 7 56199523
Post polio syndrome 17.62 9.98 4 92533 7 56199523
Mucosal inflammation 17.52 9.98 27 92510 42783 56156747
Chest pain 17.51 9.98 422 92115 189375 56010155
Upper-airway cough syndrome 17.38 9.98 44 92493 9394 56190136
Therapeutic response decreased 17.38 9.98 38 92499 52720 56146810
Chlamydial infection 17.38 9.98 9 92528 300 56199230
Increased bronchial secretion 17.29 9.98 17 92520 1590 56197940
Aspergillus infection 17.23 9.98 38 92499 7427 56192103
Meningism 17.07 9.98 10 92527 426 56199104
Staphylococcal infection 16.98 9.98 113 92424 37505 56162025
Bronchial secretion retention 16.90 9.98 18 92519 1850 56197680
Hypotension 16.84 9.98 300 92237 250208 55949322
Adverse drug reaction 16.82 9.98 53 92484 65079 56134451
Immune reconstitution inflammatory syndrome 16.78 9.98 32 92505 5642 56193888
Weight increased 16.77 9.98 271 92266 229432 55970098
Laryngeal mass 16.72 9.98 5 92532 35 56199495
Palmar-plantar erythrodysaesthesia syndrome 16.44 9.98 7 92530 21058 56178472
Acute respiratory failure 16.42 9.98 97 92440 30897 56168633
Immunodeficiency common variable 16.40 9.98 7 92530 149 56199381
Mucocutaneous candidiasis 16.38 9.98 4 92533 11 56199519
Pigment nephropathy 16.37 9.98 5 92532 38 56199492
Bronchogram abnormal 16.24 9.98 3 92534 0 56199530
Portal hypertensive enteropathy 16.24 9.98 3 92534 0 56199530
General physical health deterioration 16.20 9.98 190 92347 169820 56029710
Tachypnoea 16.18 9.98 59 92478 15371 56184159
Cholestasis 16.09 9.98 87 92450 26826 56172704
Iris transillumination defect 16.05 9.98 6 92531 89 56199441
Injection site bruising 16.05 9.98 24 92513 38497 56161033
Myasthenia gravis 16.00 9.98 27 92510 4329 56195201
Chest X-ray abnormal 15.99 9.98 26 92511 4044 56195486
Gastrooesophageal reflux disease 15.95 9.98 208 92329 83049 56116481
Crystal arthropathy 15.89 9.98 8 92529 251 56199279
Cardiac murmur 15.89 9.98 48 92489 11353 56188177
Emphysema 15.83 9.98 44 92493 9932 56189598
Adverse event 15.79 9.98 43 92494 55333 56144197
Cognitive disorder 15.69 9.98 36 92501 49097 56150433
Hemianopia heteronymous 15.62 9.98 5 92532 45 56199485
Injection site swelling 15.53 9.98 30 92507 43548 56155982
Ill-defined disorder 15.52 9.98 59 92478 68484 56131046
Peak expiratory flow rate abnormal 15.46 9.98 6 92531 99 56199431
Multiple allergies 15.40 9.98 45 92492 10451 56189079
Leukaemoid reaction 15.33 9.98 7 92530 176 56199354
Hypoxic-ischaemic encephalopathy 15.22 9.98 25 92512 3920 56195610
Eosinophilic pneumonia chronic 15.12 9.98 7 92530 182 56199348
Thermal burn 15.08 9.98 30 92507 5455 56194075
Erythema multiforme 15.02 9.98 42 92495 9512 56190018
Lung disorder 14.93 9.98 142 92395 52455 56147075
Pharyngeal enanthema 14.81 9.98 5 92532 54 56199476
Neural tube defect 14.74 9.98 7 92530 193 56199337
Gait inability 14.72 9.98 29 92508 41789 56157741
Lemierre syndrome 14.69 9.98 6 92531 114 56199416
COVID-19 treatment 14.64 9.98 6 92531 115 56199415
Arthritis 14.61 9.98 100 92437 99752 56099778
Hypersensitivity pneumonitis 14.58 9.98 19 92518 2418 56197112
Humidity intolerance 14.51 9.98 8 92529 303 56199227
Nasal congestion 14.45 9.98 149 92388 56221 56143309
Respiratory tract inflammation 14.44 9.98 10 92527 571 56198959
Depressive symptom 14.43 9.98 23 92514 3518 56196012
Rebound acid hypersecretion 14.40 9.98 8 92529 308 56199222
Oesophagogastroduodenoscopy 14.36 9.98 6 92531 121 56199409
Pneumonia bacterial 14.34 9.98 37 92500 7991 56191539
Hypercapnia 14.17 9.98 28 92509 5068 56194462
Acute kidney injury 14.16 9.98 506 92031 240257 55959273
Hyponatraemia 14.11 9.98 104 92433 102035 56097495
Paraesthesia oral 14.11 9.98 54 92483 14395 56185135
Disease progression 14.10 9.98 108 92429 105065 56094465
Hypofibrinogenaemia 14.08 9.98 13 92524 1124 56198406
Hepatitis cholestatic 14.07 9.98 32 92505 6382 56193148
Catastrophic reaction 14.05 9.98 4 92533 23 56199507
Ear discomfort 14.04 9.98 34 92503 7061 56192469
Ventricular tachycardia 13.98 9.98 60 92477 16841 56182689
Mycoplasma infection 13.92 9.98 9 92528 458 56199072
Lymph node abscess 13.91 9.98 4 92533 24 56199506
Infusion site streaking 13.80 9.98 9 92528 465 56199065
Foetal death 13.75 9.98 38 92499 8549 56190981
Urinary tract infection 13.74 9.98 296 92241 240217 55959313
Meningoencephalitis bacterial 13.70 9.98 5 92532 69 56199461
Prescribed overdose 13.67 9.98 10 92527 22286 56177244
Autoimmune hepatitis 13.63 9.98 36 92501 7885 56191645
Respiratory distress 13.62 9.98 94 92443 31573 56167957
Sleep disorder 13.60 9.98 61 92476 67602 56131928
Seasonal allergy 13.59 9.98 60 92477 17048 56182482
Muscle spasticity 13.52 9.98 8 92529 19952 56179578
Disease risk factor 13.51 9.98 5 92532 72 56199458
Brain hypoxia 13.49 9.98 9 92528 483 56199047
Monoclonal gammopathy 13.49 9.98 10 92527 636 56198894
Hypoacusis 13.44 9.98 71 92466 21697 56177833
Forced vital capacity decreased 13.44 9.98 12 92525 994 56198536
Local reaction 13.42 9.98 10 92527 641 56198889
Urethral stenosis 13.42 9.98 7 92530 237 56199293
Cholecystitis 13.32 9.98 53 92484 14382 56185148
Sputum retention 13.30 9.98 9 92528 495 56199035
Injection site reaction 13.28 9.98 44 92493 53203 56146327
Babesiosis 13.26 9.98 7 92530 243 56199287
Pneumonitis 13.16 9.98 93 92444 31471 56168059
Sinus congestion 13.15 9.98 56 92481 15668 56183862
Liver injury 13.09 9.98 31 92506 41817 56157713
Sinus disorder 13.06 9.98 68 92469 20666 56178864
Prescribed underdose 12.96 9.98 9 92528 20608 56178922
Kawasaki's disease 12.95 9.98 3 92534 6 56199524
Asthmatic crisis 12.93 9.98 15 92522 1695 56197835
Gallbladder hypofunction 12.92 9.98 9 92528 519 56199011
Corneal perforation 12.89 9.98 9 92528 521 56199009
Procedural anxiety 12.72 9.98 10 92527 694 56198836
Veillonella infection 12.70 9.98 4 92533 34 56199496
Tympanic membrane hyperaemia 12.64 9.98 3 92534 7 56199523
Balance disorder 12.54 9.98 74 92463 76446 56123084
Pneumonia necrotising 12.52 9.98 8 92529 399 56199131
Psoriasis 12.51 9.98 95 92442 92597 56106933
Cerebral venous sinus thrombosis 12.46 9.98 15 92522 1763 56197767
Dermatosis 12.42 9.98 7 92530 277 56199253
Eye irritation 12.40 9.98 63 92474 18965 56180565
Nosocomial infection 12.37 9.98 14 92523 1540 56197990
Bacterial disease carrier 12.35 9.98 11 92526 908 56198622
Injection site warmth 12.35 9.98 4 92533 14239 56185291
Breast cancer metastatic 12.30 9.98 5 92532 15464 56184066
Nocardiosis 12.26 9.98 15 92522 1793 56197737
Diabetic ketoacidosis 12.18 9.98 8 92529 18863 56180667
Neisseria infection 12.14 9.98 5 92532 97 56199433
Deafness neurosensory 12.09 9.98 25 92512 4673 56194857
Altered state of consciousness 12.07 9.98 12 92525 23009 56176521
Sopor 12.04 9.98 10 92527 20912 56178618
Developmental delay 12.03 9.98 13 92524 1359 56198171
Ruptured ectopic pregnancy 12.02 9.98 8 92529 428 56199102
Central nervous system fungal infection 11.96 9.98 5 92532 101 56199429
Stomatococcal infection 11.91 9.98 5 92532 102 56199428
Product colour issue 11.91 9.98 9 92528 589 56198941
Muscular weakness 11.87 9.98 112 92425 104340 56095190
Osteonecrosis of jaw 11.86 9.98 23 92514 33335 56166195
Pneumonia aspiration 11.83 9.98 22 92515 32389 56167141
Dysarthria 11.82 9.98 30 92507 39520 56160010
HIV infection 11.72 9.98 8 92529 446 56199084
Respiratory syncytial virus infection 11.71 9.98 27 92510 5434 56194096
Pneumopericardium 11.70 9.98 4 92533 45 56199485
Vascular parkinsonism 11.69 9.98 5 92532 107 56199423
Interleukin level increased 11.62 9.98 7 92530 314 56199216
Biopsy colon abnormal 11.61 9.98 5 92532 109 56199421
Cranial nerve paralysis 11.61 9.98 5 92532 109 56199421
Metastases to liver 11.61 9.98 11 92526 21575 56177955
Sputum purulent 11.59 9.98 11 92526 985 56198545
Increased upper airway secretion 11.50 9.98 20 92517 3284 56196246
Paranasal sinus inflammation 11.47 9.98 8 92529 462 56199068
Acute sinusitis 11.46 9.98 21 92516 3592 56195938
Dysentery 11.46 9.98 10 92527 803 56198727
Rhinovirus infection 11.45 9.98 22 92515 3900 56195630
Constipation 11.40 9.98 249 92288 201694 55997836
Acute disseminated encephalomyelitis 11.37 9.98 6 92531 208 56199322
Anal inflammation 11.37 9.98 6 92531 208 56199322
Eosinophilic pneumonia acute 11.37 9.98 7 92530 327 56199203
Anal skin tags 11.35 9.98 8 92529 470 56199060
Abscess bacterial 11.35 9.98 6 92531 209 56199321
Dysphonia 11.29 9.98 112 92425 41835 56157695
Depressed level of consciousness 11.27 9.98 51 92486 56382 56143148
BK virus infection 11.26 9.98 19 92518 3045 56196485
Mucosal dryness 11.26 9.98 17 92520 2481 56197049
Epilepsy 11.22 9.98 15 92522 25216 56174314
Purpura 11.18 9.98 40 92497 10322 56189208
Cardiac failure 11.14 9.98 84 92453 82009 56117521
Lung diffusion test decreased 11.07 9.98 9 92528 656 56198874
Dehydration 11.05 9.98 189 92348 158636 56040894
Genital ulceration 11.03 9.98 8 92529 492 56199038
Normal newborn 10.93 9.98 32 92505 7438 56192092
Hypertransaminasaemia 10.91 9.98 24 92513 4683 56194847
Encephalitis protozoal 10.89 9.98 3 92534 15 56199515
Otitis media fungal 10.89 9.98 3 92534 15 56199515
Hypoventilation 10.87 9.98 23 92514 4369 56195161
Drug ineffective 10.81 9.98 1335 91202 917654 55281876
Ureteric perforation 10.73 9.98 3 92534 16 56199514
Catarrh 10.66 9.98 7 92530 366 56199164
HIV-associated neurocognitive disorder 10.66 9.98 5 92532 134 56199396
Hyperbilirubinaemia 10.62 9.98 39 92498 10196 56189334
Immune reconstitution inflammatory syndrome associated tuberculosis 10.59 9.98 7 92530 370 56199160
Angina bullosa haemorrhagica 10.49 9.98 5 92532 139 56199391
Immunosuppressant drug level increased 10.44 9.98 19 92518 3234 56196296
SJS-TEN overlap 10.37 9.98 6 92531 250 56199280
Bacterial infection 10.34 9.98 56 92481 17274 56182256
Vulvovaginal candidiasis 10.30 9.98 18 92519 2968 56196562
Amaurosis 10.30 9.98 8 92529 546 56198984
Rash maculo-papular 10.26 9.98 82 92455 28825 56170705
Photodermatosis 10.25 9.98 7 92530 391 56199139
Basal cell carcinoma 10.23 9.98 16 92521 25205 56174325
Blood pressure diastolic decreased 10.21 9.98 10 92527 19313 56180217
Intestinal anastomosis 10.10 9.98 7 92530 400 56199130
ECG signs of myocardial ischaemia 10.09 9.98 4 92533 70 56199460
Vaginal abscess 10.09 9.98 7 92530 401 56199129
Injection site haemorrhage 10.08 9.98 13 92524 22188 56177342
Joint effusion 10.05 9.98 6 92531 14892 56184638

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
Off label use 2005.94 10.56 2973 62646 344301 31287424
Infective pulmonary exacerbation of cystic fibrosis 615.15 10.56 290 65329 6194 31625531
Electrocardiogram QT prolonged 404.20 10.56 444 65175 37543 31594182
Drug hypersensitivity 202.24 10.56 457 65162 72142 31559583
Asthma 196.70 10.56 332 65287 42279 31589446
Product use in unapproved indication 195.24 10.56 547 65072 98624 31533101
Drug ineffective for unapproved indication 192.63 10.56 210 65409 17580 31614145
Long QT syndrome 162.86 10.56 85 65534 2271 31629454
Drug interaction 140.88 10.56 823 64796 207720 31424005
Bronchiectasis 135.84 10.56 118 65501 7462 31624263
Drug abuse 134.61 10.56 13 65606 87745 31543980
No adverse event 130.20 10.56 181 65438 19444 31612281
Immune reconstitution inflammatory syndrome 128.12 10.56 118 65501 8060 31623665
Hepatitis 125.23 10.56 189 65430 21877 31609848
Cystic fibrosis 121.98 10.56 66 65553 1900 31629825
Wheezing 116.65 10.56 241 65378 35745 31595980
Completed suicide 112.02 10.56 26 65593 91488 31540237
Hypertransaminasaemia 111.18 10.56 83 65536 4221 31627504
Obstructive airways disorder 110.92 10.56 134 65485 12530 31619195
Drug effective for unapproved indication 110.54 10.56 61 65558 1827 31629898
COVID-19 108.32 10.56 303 65316 54518 31577207
Condition aggravated 104.02 10.56 637 64982 163372 31468353
Productive cough 103.32 10.56 220 65399 33320 31598405
Fall 99.98 10.56 144 65475 185945 31445780
Cough 96.70 10.56 541 65078 134273 31497452
Haemoptysis 94.41 10.56 207 65412 31982 31599743
Vanishing bile duct syndrome 88.61 10.56 37 65582 584 31631141
Death 87.49 10.56 417 65202 360152 31271573
Breath sounds abnormal 84.35 10.56 81 65538 5831 31625894
Pulmonary function test decreased 80.06 10.56 69 65550 4316 31627409
Product packaging quantity issue 78.77 10.56 37 65582 782 31630943
Stevens-Johnson syndrome 78.29 10.56 134 65485 17238 31614487
Malignant neoplasm progression 77.85 10.56 33 65586 78965 31552760
Dysplastic naevus 76.46 10.56 31 65588 452 31631273
Solar lentigo 75.85 10.56 31 65588 462 31631263
Photodermatosis 74.78 10.56 31 65588 480 31631245
Pneumonia 72.69 10.56 1033 64586 334279 31297446
Eosinophil count abnormal 69.52 10.56 25 65594 257 31631468
Forced expiratory volume decreased 69.38 10.56 54 65565 2923 31628802
Mycobacterial infection 68.77 10.56 48 65571 2195 31629530
Congenital hiatus hernia 67.46 10.56 30 65589 556 31631169
Toxicity to various agents 65.04 10.56 178 65441 181309 31450416
Mycobacterium avium complex infection 63.14 10.56 47 65572 2379 31629346
Ototoxicity 59.53 10.56 40 65579 1718 31630007
Torsade de pointes 59.19 10.56 72 65547 6778 31624947
Sinusitis 56.61 10.56 186 65433 36510 31595215
Febrile neutropenia 55.39 10.56 105 65514 121744 31509981
Mycobacterium abscessus infection 53.99 10.56 26 65593 582 31631143
Sleep disorder due to a general medical condition 51.07 10.56 51 65568 3851 31627874
COVID-19 pneumonia 51.06 10.56 93 65526 12562 31619163
Acute respiratory distress syndrome 50.77 10.56 138 65481 24402 31607323
Full blood count abnormal 50.06 10.56 107 65512 16240 31615485
Mucocutaneous disorder 50.00 10.56 16 65603 111 31631614
Toxic epidermal necrolysis 49.97 10.56 119 65500 19405 31612320
Rheumatoid arthritis 48.66 10.56 19 65600 47790 31583935
Sputum increased 48.03 10.56 38 65581 2107 31629618
Somnolence 47.59 10.56 83 65536 99362 31532363
Pathogen resistance 47.19 10.56 73 65546 8628 31623097
Mycobacterium chelonae infection 46.25 10.56 25 65594 718 31631007
Hepatitis acute 46.17 10.56 63 65556 6646 31625079
Myocardial infarction 45.47 10.56 105 65514 113349 31518376
General physical health deterioration 45.44 10.56 105 65514 113330 31518395
Respiratory disorder 44.62 10.56 108 65511 17792 31613933
Prostate cancer 43.44 10.56 12 65607 37589 31594136
Transaminases increased 42.70 10.56 129 65490 24212 31607513
Bronchitis 42.66 10.56 176 65443 38541 31593184
Babesiosis 42.58 10.56 14 65605 107 31631618
Pseudomonas infection 42.51 10.56 81 65538 11320 31620405
Dizziness 42.11 10.56 241 65378 198906 31432819
Dehydration 41.01 10.56 119 65500 118992 31512733
Parathyroid gland enlargement 40.68 10.56 14 65605 125 31631600
Alanine aminotransferase increased 40.47 10.56 279 65340 74377 31557348
Cystic fibrosis respiratory infection suppression 40.18 10.56 16 65603 222 31631503
Upper respiratory fungal infection 39.54 10.56 14 65605 137 31631588
Constipation 39.05 10.56 129 65490 123862 31507863
Fatigue 38.87 10.56 476 65143 334730 31296995
Acute respiratory failure 38.70 10.56 137 65482 27918 31603807
Respiratory failure 38.42 10.56 349 65270 101100 31530625
Sputum discoloured 38.37 10.56 58 65561 6718 31625007
Intentional overdose 38.10 10.56 19 65600 41370 31590355
Bronchiolitis obliterans syndrome 37.29 10.56 14 65605 164 31631561
Decreased appetite 37.09 10.56 177 65442 153040 31478685
Drug resistance 36.27 10.56 119 65500 23334 31608391
Coma 36.24 10.56 20 65599 41130 31590595
Forced expiratory volume 35.08 10.56 12 65607 105 31631620
Bronchopulmonary aspergillosis 33.70 10.56 82 65537 13552 31618173
Cystic fibrosis related diabetes 33.62 10.56 13 65606 166 31631559
Cryptococcal meningoencephalitis 32.97 10.56 12 65607 128 31631597
Obliterative bronchiolitis 32.89 10.56 24 65595 1178 31630547
Lung transplant rejection 32.45 10.56 20 65599 739 31630986
Hypertriglyceridaemia 32.34 10.56 58 65561 7740 31623985
HIV associated nephropathy 32.24 10.56 15 65604 310 31631415
Pain 31.88 10.56 241 65378 186518 31445207
COVID-19 treatment 31.85 10.56 14 65605 252 31631473
Confusional state 31.69 10.56 155 65464 133179 31498546
Aspergillus infection 31.39 10.56 72 65547 11456 31620269
Chronic obstructive pulmonary disease 30.80 10.56 179 65440 44987 31586738
Scleroderma 29.53 10.56 24 65595 1383 31630342
Lung transplant 29.32 10.56 27 65592 1843 31629882
Lung diffusion disorder 28.79 10.56 10 65609 92 31631633
Dyspnoea 28.67 10.56 921 64698 342558 31289167
Bronchopulmonary aspergillosis allergic 28.11 10.56 17 65602 607 31631118
Distal intestinal obstruction syndrome 28.10 10.56 13 65606 265 31631460
Tachyarrhythmia 27.91 10.56 34 65585 3205 31628520
Product quality issue 27.89 10.56 85 65534 16026 31615699
Lung hyperinflation 27.89 10.56 19 65600 835 31630890
Cytokine storm 27.86 10.56 17 65602 617 31631108
Lip erythema 27.21 10.56 8 65611 40 31631685
Blood immunoglobulin E increased 27.08 10.56 28 65591 2203 31629522
Herpes simplex viraemia 27.01 10.56 9 65610 72 31631653
Hepatocellular injury 27.00 10.56 102 65517 21442 31610283
Mucormycosis 26.46 10.56 44 65575 5526 31626199
Overdose 26.01 10.56 89 65530 84575 31547150
Cryptococcosis 25.99 10.56 28 65591 2310 31629415
Viral infection 25.82 10.56 81 65538 15512 31616213
Atypical mycobacterial lower respiratory tract infection 25.71 10.56 8 65611 50 31631675
Upper-airway cough syndrome 25.62 10.56 32 65587 3095 31628630
Graft versus host disease in lung 25.57 10.56 15 65604 506 31631219
Seizure 25.46 10.56 113 65506 99655 31532070
Neutropenia 25.44 10.56 178 65441 140186 31491539
Actinic keratosis 25.43 10.56 37 65582 4142 31627583
Asthenia 25.29 10.56 321 65298 224434 31407291
Stenotrophomonas infection 25.17 10.56 25 65594 1875 31629850
Suicide attempt 25.12 10.56 24 65595 37224 31594501
Rash maculovesicular 25.07 10.56 7 65612 28 31631697
Cardiac failure 24.65 10.56 93 65526 85860 31545865
Pharyngeal erythema 24.54 10.56 15 65604 546 31631179
Gastrointestinal haemorrhage 24.54 10.56 88 65531 82461 31549264
Hepatitis cholestatic 24.49 10.56 49 65570 7097 31624628
Pain in extremity 23.78 10.56 142 65477 116061 31515664
Nasal mucosal disorder 23.78 10.56 9 65610 108 31631617
Plasma cell myeloma 23.70 10.56 51 65568 56480 31575245
Conjunctival hyperaemia 23.70 10.56 26 65593 2190 31629535
Urinary tract infection 23.48 10.56 81 65538 76788 31554937
Methaemoglobinaemia 23.42 10.56 30 65589 2976 31628749
Anaemia 23.26 10.56 307 65312 213215 31418510
Haemolytic anaemia 23.24 10.56 58 65561 9738 31621987
Chlamydial infection 23.22 10.56 10 65609 171 31631554
NPM1 gene mutation 23.13 10.56 9 65610 117 31631608
Blood pressure increased 22.94 10.56 86 65533 79547 31552178
Liver function test increased 22.88 10.56 68 65551 12646 31619079
Urethritis mycoplasmal 22.81 10.56 6 65613 18 31631707
Jaw cyst 22.81 10.56 6 65613 18 31631707
Cerebrovascular accident 22.79 10.56 86 65533 79398 31552327
Eosinophilia 22.75 10.56 102 65517 23151 31608574
HIV infection 22.74 10.56 22 65597 1598 31630127
Deafness neurosensory 22.58 10.56 28 65591 2688 31629037
Total lung capacity abnormal 22.21 10.56 9 65610 131 31631594
Bronchial disorder 22.17 10.56 20 65599 1329 31630396
Complications of transplanted lung 22.12 10.56 10 65609 193 31631532
Drug ineffective 22.10 10.56 1015 64604 394558 31237167
Disseminated cryptococcosis 22.03 10.56 20 65599 1340 31630385
Wrong technique in product usage process 21.89 10.56 22 65597 33321 31598404
Malignant melanoma in situ 21.85 10.56 20 65599 1354 31630371
Pneumonia legionella 21.82 10.56 22 65597 1680 31630045
Upper respiratory tract infection 21.63 10.56 119 65500 29303 31602422
Blood pressure fluctuation 21.59 10.56 10 65609 22726 31608999
Gonorrhoea 21.46 10.56 7 65612 52 31631673
Injection site pain 21.45 10.56 24 65595 34610 31597115
Liver injury 21.35 10.56 69 65550 13423 31618302
Hypoxia 21.05 10.56 177 65442 50136 31581589
Bronchial hyperreactivity 20.99 10.56 20 65599 1425 31630300
Cerebral infarction 20.95 10.56 14 65605 25963 31605762
Deafness 20.79 10.56 58 65561 10407 31621318
Enterovirus infection 20.76 10.56 15 65604 725 31631000
Ascites 20.74 10.56 33 65586 40980 31590745
Carbon dioxide increased 20.59 10.56 17 65602 1002 31630723
Premature baby 20.58 10.56 83 65536 17983 31613742
Bladder cancer 20.53 10.56 3 65616 14722 31617003
Oedema peripheral 20.53 10.56 138 65481 109701 31522024
Pneumonia mycoplasmal 20.45 10.56 14 65605 620 31631105
Infective chondritis 20.44 10.56 5 65614 10 31631715
Hepatic necrosis 20.24 10.56 31 65588 3632 31628093
Iris adhesions 20.21 10.56 10 65609 238 31631487
Bacterial pericarditis 20.10 10.56 7 65612 65 31631660
Contraindicated product administered 19.88 10.56 8 65611 19764 31611961
Drug reaction with eosinophilia and systemic symptoms 19.83 10.56 118 65501 29900 31601825
Fungal disease carrier 19.69 10.56 10 65609 252 31631473
Linear IgA disease 19.68 10.56 20 65599 1542 31630183
Therapeutic product effect decreased 19.49 10.56 22 65597 31600 31600125
Disease progression 18.79 10.56 110 65509 90354 31541371
Pneumothorax 18.72 10.56 77 65542 16833 31614892
Pulmonary function test abnormal 18.63 10.56 23 65596 2198 31629527
Mediastinal shift 18.50 10.56 4 65615 3 31631722
Cardiac failure congestive 18.43 10.56 93 65526 79294 31552431
Acquired immunodeficiency syndrome 18.38 10.56 12 65607 491 31631234
Cognitive disorder 18.08 10.56 15 65604 24908 31606817
Influenza 18.05 10.56 155 65464 44170 31587555
Lung infiltration 18.02 10.56 61 65558 12152 31619573
Alcohol intolerance 18.01 10.56 11 65608 400 31631325
Andersen-Tawil syndrome 17.97 10.56 4 65615 4 31631721
Nervous system neoplasm 17.95 10.56 8 65611 149 31631576
Rubber sensitivity 17.95 10.56 8 65611 149 31631576
Vestibular disorder 17.92 10.56 16 65603 1049 31630676
Antinuclear antibody negative 17.91 10.56 5 65614 20 31631705
Arthralgia 17.86 10.56 214 65405 151210 31480515
Respiratory syncytial virus infection 17.85 10.56 30 65589 3801 31627924
Lip oedema 17.80 10.56 23 65596 2301 31629424
Liver function test 17.69 10.56 6 65613 51 31631674
Acoustic neuroma 17.57 10.56 8 65611 157 31631568
Myasthenia gravis crisis 17.56 10.56 12 65607 530 31631195
Asthma-chronic obstructive pulmonary disease overlap syndrome 17.55 10.56 15 65604 927 31630798
Pneumomediastinum 17.55 10.56 22 65597 2135 31629590
Chimerism 17.46 10.56 9 65610 234 31631491
Platelet count decreased 17.20 10.56 146 65473 110289 31521436
Cystic fibrosis lung 17.20 10.56 6 65613 56 31631669
Restrictive allograft syndrome 17.17 10.56 5 65614 24 31631701
Tinnitus 17.15 10.56 73 65546 16202 31615523
Hypercapnia 17.06 10.56 30 65589 3941 31627784
Osteonecrosis of jaw 17.01 10.56 7 65612 17064 31614661
Genital ulceration 16.99 10.56 8 65611 170 31631555
Jarisch-Herxheimer reaction 16.82 10.56 11 65608 451 31631274
Interstitial lung disease 16.60 10.56 68 65551 61335 31570390
Oral mucosa erosion 16.41 10.56 14 65605 863 31630862
Rhodococcus infection 16.34 10.56 8 65611 186 31631539
Contusion 16.30 10.56 27 65592 33001 31598724
Rash maculo-papular 16.29 10.56 100 65519 25619 31606106
Hypotension 16.29 10.56 312 65307 204306 31427419
Urinary retention 16.25 10.56 28 65591 33697 31598028
Pancreatic failure 16.23 10.56 13 65606 734 31630991
SJS-TEN overlap 16.20 10.56 9 65610 273 31631452
Hepatomegaly 16.17 10.56 50 65569 9500 31622225
Decreased activity 16.04 10.56 29 65590 3894 31627831
Palmar-plantar erythrodysaesthesia syndrome 16.00 10.56 6 65613 15477 31616248
Back pain 16 10.56 147 65472 109266 31522459
Cerebral toxoplasmosis 16.00 10.56 18 65601 1559 31630166
Pulmonary alveolar haemorrhage 15.99 10.56 40 65579 6726 31624999
Secretion discharge 15.90 10.56 33 65586 4904 31626821
Lung disorder 15.89 10.56 118 65501 32194 31599531
Glucose-6-phosphate dehydrogenase deficiency 15.88 10.56 7 65612 127 31631598
Aspartate aminotransferase increased 15.85 10.56 199 65420 62520 31569205
Tooth discolouration 15.81 10.56 10 65609 387 31631338
Hypofibrinogenaemia 15.76 10.56 18 65601 1585 31630140
Lymph node palpable 15.71 10.56 5 65614 34 31631691
Acute generalised exanthematous pustulosis 15.65 10.56 37 65582 6003 31625722
Drug-induced liver injury 15.60 10.56 95 65524 24268 31607457
Mastocytosis 15.59 10.56 5 65614 35 31631690
Haemoglobin E disease 15.55 10.56 3 65616 0 31631725
Senile pruritus 15.55 10.56 3 65616 0 31631725
Chorioretinitis 15.43 10.56 10 65609 404 31631321
CD4 lymphocytes increased 15.28 10.56 8 65611 215 31631510
End stage renal disease 15.19 10.56 44 65575 8065 31623660
Gait disturbance 15.16 10.56 96 65523 77399 31554326
Pseudomembranous colitis 15.16 10.56 23 65596 2672 31629053
Respiratory symptom 15.15 10.56 16 65603 1290 31630435
Oropharyngeal candidiasis 15.06 10.56 12 65607 672 31631053
Dysarthria 15.05 10.56 27 65592 31990 31599735
Immunodeficiency common variable 14.99 10.56 7 65612 146 31631579
ADAMTS13 activity decreased 14.96 10.56 6 65613 85 31631640
Deafness unilateral 14.88 10.56 19 65600 1879 31629846
Bronchomalacia 14.83 10.56 6 65613 87 31631638
Metastases to liver 14.81 10.56 4 65615 12723 31619002
Hospitalisation 14.78 10.56 163 65456 49644 31582081
Clostridium difficile colitis 14.77 10.56 63 65556 13993 31617732
Hyponatraemia 14.66 10.56 91 65528 73708 31558017
Forced vital capacity decreased 14.61 10.56 12 65607 702 31631023
Borderline personality disorder 14.47 10.56 9 65610 338 31631387
Hypocapnia 14.32 10.56 7 65612 162 31631563
Pneumonia pseudomonal 14.31 10.56 26 65593 3503 31628222
Palatal oedema 14.26 10.56 12 65607 726 31630999
Enterobacter infection 14.15 10.56 20 65599 2180 31629545
Haemoglobin decreased 14.15 10.56 157 65462 112518 31519207
Bronchopleural fistula 14.14 10.56 10 65609 467 31631258
Myopia 14.00 10.56 14 65605 1059 31630666
Syncope 13.99 10.56 111 65508 85071 31546654
Severe acute respiratory syndrome 13.94 10.56 5 65614 51 31631674
Atypical mycobacterial infection 13.91 10.56 12 65607 751 31630974
Pneumonia escherichia 13.74 10.56 9 65610 370 31631355
Wrong dose 13.68 10.56 10 65609 492 31631233
Neurological examination abnormal 13.66 10.56 8 65611 269 31631456
Cytomegalovirus chorioretinitis 13.58 10.56 25 65594 3403 31628322
Gastrooesophageal reflux disease 13.56 10.56 118 65501 33753 31597972
Micturition urgency 13.55 10.56 34 65585 5726 31625999
Tongue discolouration 13.52 10.56 14 65605 1103 31630622
Disorientation 13.50 10.56 27 65592 30717 31601008
Viral pharyngitis 13.50 10.56 6 65613 111 31631614
Chest discomfort 13.50 10.56 159 65460 49210 31582515
Papillary muscle rupture 13.47 10.56 3 65616 3 31631722
Neutrophil count decreased 13.42 10.56 50 65569 46344 31585381
Hypoglycaemia 13.41 10.56 57 65562 50889 31580836
Haemorrhoids thrombosed 13.34 10.56 7 65612 189 31631536
Rotavirus infection 13.32 10.56 9 65610 390 31631335
Rhinalgia 13.32 10.56 9 65610 390 31631335
Anosmia 13.32 10.56 19 65600 2089 31629636
Low birth weight baby 13.23 10.56 38 65581 6932 31624793
Anticoagulation drug level above therapeutic 13.17 10.56 18 65601 1901 31629824
Cholestasis 13.15 10.56 93 65526 24982 31606743
Red blood cell sedimentation rate decreased 13.14 10.56 5 65614 61 31631664
Urinary incontinence 13.09 10.56 10 65609 17310 31614415
Urosepsis 13.06 10.56 4 65615 11716 31620009
Rheumatic fever 13.00 10.56 4 65615 24 31631701
Rash 12.97 10.56 525 65094 200961 31430764
Hyperkalaemia 12.96 10.56 79 65540 64272 31567453
Rhinocerebral mucormycosis 12.90 10.56 9 65610 411 31631314
Pleural fistula 12.86 10.56 4 65615 25 31631700
Therapeutic product ineffective for unapproved indication 12.86 10.56 4 65615 25 31631700
Respiratory depression 12.85 10.56 7 65612 14503 31617222
Prostatic specific antigen increased 12.78 10.56 6 65613 13532 31618193
Therapeutic response decreased 12.78 10.56 22 65597 26487 31605238
Flushing 12.77 10.56 27 65592 30101 31601624
Small intestinal obstruction 12.67 10.56 6 65613 13466 31618259
Accidental exposure to product 12.67 10.56 4 65615 11491 31620234
Optic neuropathy 12.58 10.56 17 65602 1776 31629949
Seborrhoea 12.52 10.56 7 65612 215 31631510
Folliculitis 12.52 10.56 27 65592 4121 31627604
Infusion related reaction 12.50 10.56 54 65565 48001 31583724
Sputum retention 12.49 10.56 9 65610 433 31631292
Respiratory distress 12.46 10.56 115 65504 33438 31598287
Eosinophilic pustular folliculitis 12.39 10.56 5 65614 72 31631653
Lip ulceration 12.32 10.56 11 65608 721 31631004
Chronic sinusitis 12.32 10.56 17 65602 1812 31629913
Musculoskeletal stiffness 12.31 10.56 44 65575 41281 31590444
Achromotrichia congenital 12.26 10.56 3 65616 6 31631719
Atrial conduction time prolongation 12.26 10.56 3 65616 6 31631719
Antibiotic associated colitis 12.26 10.56 3 65616 6 31631719
Cutaneous extramedullary haemopoiesis 12.26 10.56 3 65616 6 31631719
Adverse event 12.18 10.56 10 65609 16695 31615030
Occupational exposure to air contaminants 12.12 10.56 6 65613 143 31631582
Acute myocardial infarction 12.10 10.56 59 65560 50764 31580961
Prothrombin level decreased 12.09 10.56 13 65606 1070 31630655
Loss of personal independence in daily activities 12.08 10.56 100 65519 28188 31603537
Hyperaemia 12.07 10.56 13 65606 1072 31630653
Tuberculosis gastrointestinal 12.04 10.56 7 65612 232 31631493
Superinfection bacterial 11.94 10.56 11 65608 751 31630974
Coronavirus test positive 11.91 10.56 9 65610 466 31631259
Multiple sclerosis relapse 11.91 10.56 5 65614 12042 31619683
Eosinophilic pleural effusion 11.91 10.56 7 65612 237 31631488
Pneumonia acinetobacter 11.85 10.56 5 65614 81 31631644
Abdominal wall haematoma 11.85 10.56 16 65603 1671 31630054
Delusion 11.83 10.56 5 65614 11992 31619733
Acute sinusitis 11.81 10.56 14 65605 1283 31630442
Kidney infection 11.80 10.56 29 65590 4821 31626904
Bacterial infection 11.78 10.56 58 65561 13681 31618044
Blood glucose increased 11.78 10.56 76 65543 61007 31570718
Memory impairment 11.76 10.56 40 65579 38090 31593635
Balance disorder 11.71 10.56 39 65580 37383 31594342
Respiration abnormal 11.71 10.56 21 65598 2801 31628924
Depressed level of consciousness 11.56 10.56 41 65578 38560 31593165
Nail pitting 11.52 10.56 7 65612 252 31631473
Toxic optic neuropathy 11.51 10.56 11 65608 787 31630938
Tremor 11.46 10.56 102 65517 76318 31555407
Heart rate decreased 11.43 10.56 26 65593 28240 31603485
Brain abscess 11.43 10.56 21 65598 2854 31628871
Rhonchi 11.43 10.56 16 65603 1729 31629996
Diaphragmatic hernia 11.42 10.56 7 65612 256 31631469
Neurilemmoma benign 11.41 10.56 3 65616 9 31631716
Hypo HDL cholesterolaemia 11.41 10.56 3 65616 9 31631716
Cardiogenic shock 11.35 10.56 18 65601 22390 31609335
Viral rash 11.23 10.56 5 65614 93 31631632
Pneumonia staphylococcal 11.20 10.56 21 65598 2899 31628826
Therapeutic product effect incomplete 11.19 10.56 139 65480 43557 31588168
Vertical infection transmission 11.17 10.56 3 65616 10 31631715
Tubulointerstitial nephritis 11.14 10.56 71 65548 18425 31613300
Eye swelling 11.13 10.56 43 65576 9133 31622592
Cerebral haemorrhage 11.11 10.56 33 65586 32779 31598946
Inguinal hernia repair 11.11 10.56 7 65612 269 31631456
Interstitial granulomatous dermatitis 11.05 10.56 6 65613 174 31631551
Pneumonia aspiration 11.03 10.56 42 65577 38684 31593041
Lethargy 10.95 10.56 42 65577 38599 31593126
Dry gangrene 10.85 10.56 8 65611 399 31631326
Syphilis 10.83 10.56 8 65611 400 31631325
Sedation 10.83 10.56 14 65605 18951 31612774
Acute hepatic failure 10.82 10.56 54 65565 12805 31618920
Muscle spasms 10.77 10.56 90 65529 68228 31563497
Incorrect product administration duration 10.76 10.56 26 65593 4276 31627449
Purpura senile 10.74 10.56 3 65616 12 31631713
Impaired quality of life 10.74 10.56 23 65596 3493 31628232
Presyncope 10.74 10.56 12 65607 17316 31614409
Bronchospasm 10.71 10.56 45 65574 9927 31621798
Hilar lymphadenopathy 10.68 10.56 11 65608 862 31630863
Drug level increased 10.66 10.56 75 65544 20111 31611614
Hepatotoxicity 10.66 10.56 72 65547 19054 31612671
Angina pectoris 10.64 10.56 29 65590 29612 31602113
Tendon disorder 10.63 10.56 19 65600 2529 31629196
Device malfunction 10.62 10.56 3 65616 9263 31622462
Hypogammaglobulinaemia 10.58 10.56 34 65585 6593 31625132
Bronchoalveolar lavage 10.57 10.56 4 65615 48 31631677

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
Off label use 2618.93 9.78 4781 125652 738279 70059732
Infective pulmonary exacerbation of cystic fibrosis 1152.19 9.78 524 129909 11634 70786377
Drug hypersensitivity 667.10 9.78 1482 128951 260977 70537034
Electrocardiogram QT prolonged 597.51 9.78 752 129681 82765 70715246
Abortion incomplete 519.79 9.78 200 130233 2862 70795149
Asthma 426.82 9.78 783 129650 120010 70678001
Cystic fibrosis 314.86 9.78 155 130278 4126 70793885
Completed suicide 298.97 9.78 34 130399 227101 70570910
Product use in unapproved indication 298.50 9.78 949 129484 206529 70591482
Rheumatoid arthritis 292.10 9.78 87 130346 291718 70506293
Drug ineffective for unapproved indication 273.78 9.78 346 130087 38192 70759819
Wheezing 267.47 9.78 557 129876 93613 70704398
Bronchiectasis 259.08 9.78 224 130209 15873 70782138
Long QT syndrome 229.00 9.78 135 130298 5192 70792819
Drug interaction 223.25 9.78 1329 129104 380112 70417899
COVID-19 220.92 9.78 554 129879 105203 70692808
Synovitis 184.19 9.78 14 130419 129214 70668797
Joint swelling 178.02 9.78 124 130309 253087 70544924
Cough 175.90 9.78 1111 129322 324266 70473745
Contraindicated product administered 172.49 9.78 22 130411 134590 70663421
Haemoptysis 170.87 9.78 325 130108 51127 70746884
Drug abuse 170.67 9.78 32 130401 147224 70650787
Pneumonia 157.89 9.78 1732 128701 594500 70203511
Productive cough 155.89 9.78 403 130030 77934 70720077
Arthralgia 151.26 9.78 451 129982 502939 70295072
Sleep disorder due to a general medical condition 151.07 9.78 137 130296 10339 70787672
Therapeutic product effect decreased 144.14 9.78 42 130391 142976 70655035
Fall 142.11 9.78 386 130047 443710 70354301
Pulmonary function test decreased 141.71 9.78 110 130323 6691 70791320
Obstructive airways disorder 139.20 9.78 204 130229 25909 70772102
Hand deformity 130.26 9.78 7 130426 86475 70711536
Immune reconstitution inflammatory syndrome 124.48 9.78 136 130297 12854 70785157
Cholecystitis chronic 122.40 9.78 116 130317 9260 70788751
Sputum discoloured 120.97 9.78 161 130272 18690 70779321
Breath sounds abnormal 120.70 9.78 135 130298 13096 70784915
Mycobacterium avium complex infection 119.96 9.78 83 130350 4223 70793788
Drug effective for unapproved indication 119.03 9.78 85 130348 4550 70793461
Premature delivery 114.38 9.78 167 130266 21137 70776874
Respiratory failure 112.96 9.78 610 129823 168125 70629886
Toxicity to various agents 111.39 9.78 347 130086 381825 70416186
Stevens-Johnson syndrome 110.89 9.78 220 130213 35687 70762324
Hypertransaminasaemia 109.86 9.78 107 130326 8836 70789175
Hepatitis 109.77 9.78 267 130166 49713 70748298
Arthropathy 106.03 9.78 73 130360 149984 70648027
Fatigue 104.73 9.78 991 129442 823328 69974683
Full blood count abnormal 102.74 9.78 206 130227 33672 70764339
Alopecia 101.01 9.78 130 130303 198360 70599651
Torsade de pointes 100.15 9.78 144 130289 17972 70780039
Acute respiratory distress syndrome 99.95 9.78 229 130204 41025 70756986
Systemic lupus erythematosus 98.93 9.78 32 130401 101870 70696141
Intentional overdose 97.18 9.78 30 130403 98405 70699606
Pathogen resistance 97.11 9.78 121 130312 13158 70784853
Chronic obstructive pulmonary disease 97.06 9.78 339 130094 77302 70720709
Infusion related reaction 96.83 9.78 133 130300 197401 70600610
Malignant neoplasm progression 96.07 9.78 52 130381 121687 70676324
Forced expiratory volume decreased 94.55 9.78 90 130343 7224 70790787
Haemorrhage 92.15 9.78 351 130082 83464 70714547
Injury 91.40 9.78 296 130137 64949 70733062
Upper respiratory tract infection 90.48 9.78 336 130097 78938 70719073
Glossodynia 87.86 9.78 25 130408 86462 70711549
No adverse event 85.21 9.78 185 130248 31968 70766043
Mycobacterial infection 85.08 9.78 62 130371 3426 70794585
Vanishing bile duct syndrome 84.71 9.78 44 130389 1315 70796696
Hypoxia 84.44 9.78 368 130065 92976 70705035
Photodermatosis 81.05 9.78 38 130395 905 70797106
Swelling 79.92 9.78 140 130293 188399 70609612
Solar lentigo 79.87 9.78 39 130394 1019 70796992
Wound 79.63 9.78 41 130392 98691 70699320
COVID-19 pneumonia 79.46 9.78 144 130289 21825 70776186
Emotional distress 77.77 9.78 195 130238 36993 70761018
Transaminases increased 76.72 9.78 225 130208 46793 70751218
Asthma-chronic obstructive pulmonary disease overlap syndrome 76.19 9.78 43 130390 1521 70796490
Somnolence 76.12 9.78 178 130255 215428 70582583
Cystic fibrosis respiratory infection suppression 75.93 9.78 29 130404 406 70797605
Dysplastic naevus 75.47 9.78 31 130402 531 70797480
Drug intolerance 74.44 9.78 193 130240 225494 70572517
Drug resistance 74.43 9.78 195 130238 37995 70760016
Helicobacter infection 73.99 9.78 8 130425 55648 70742363
Dyspnoea 73.73 9.78 1894 128539 768166 70029845
Death 73.53 9.78 593 129840 509468 70288543
Ototoxicity 71.11 9.78 52 130381 2889 70795122
Eosinophilia 70.69 9.78 198 130235 40121 70757890
Sputum increased 70.29 9.78 59 130374 4013 70793998
Condition aggravated 70.19 9.78 1140 129293 426495 70371516
Bronchopulmonary aspergillosis 70.12 9.78 133 130300 20869 70777142
Mycobacterium abscessus infection 69.73 9.78 38 130395 1254 70796757
Toxic epidermal necrolysis 69.10 9.78 194 130239 39363 70758648
Eosinophil count abnormal 68.65 9.78 30 130403 603 70797408
Congenital hiatus hernia 68.54 9.78 29 130404 537 70797474
Mobility decreased 66.47 9.78 55 130378 102944 70695067
Acute generalised exanthematous pustulosis 66.27 9.78 109 130324 15288 70782723
Exposure during pregnancy 66.20 9.78 328 130105 87389 70710622
Bronchitis 66.07 9.78 405 130028 116838 70681173
Rhinitis allergic 65.26 9.78 83 130350 9212 70788799
Drug reaction with eosinophilia and systemic symptoms 62.97 9.78 242 130191 57771 70740240
Peripheral swelling 62.51 9.78 224 130209 236339 70561672
Febrile neutropenia 61.22 9.78 183 130250 204135 70593876
Confusional state 61.02 9.78 292 130141 284106 70513905
Pseudomonas infection 59.39 9.78 117 130316 18877 70779134
Suicide attempt 58.42 9.78 37 130396 79473 70718538
Infective exacerbation of bronchiectasis 57.40 9.78 28 130405 730 70797281
Musculoskeletal stiffness 57.08 9.78 116 130317 147644 70650367
Biliary dyskinesia 57.06 9.78 42 130391 2357 70795654
Drug-induced liver injury 56.80 9.78 229 130204 55884 70742127
Factor V inhibition 55.74 9.78 22 130411 338 70797673
Alanine aminotransferase increased 54.91 9.78 461 129972 147019 70650992
Overdose 53.81 9.78 148 130285 169597 70628414
Coma 53.37 9.78 54 130379 91790 70706221
Deafness 53.37 9.78 113 130320 19190 70778821
Lip oedema 52.70 9.78 58 130375 5525 70792486
Bronchopulmonary aspergillosis allergic 52.62 9.78 37 130396 1932 70796079
Pericarditis 52.50 9.78 47 130386 84658 70713353
Stomatitis 52.13 9.78 98 130335 128413 70669598
Product packaging quantity issue 51.88 9.78 30 130403 1112 70796899
COVID-19 treatment 50.81 9.78 22 130411 432 70797579
Obliterative bronchiolitis 50.57 9.78 42 130391 2815 70795196
Acute respiratory failure 50.38 9.78 214 130219 53451 70744560
Nasal polyps 49.88 9.78 51 130382 4465 70793546
Aspergillus infection 49.86 9.78 105 130328 17763 70780248
Pneumothorax 49.37 9.78 131 130302 25715 70772296
Hepatitis acute 48.58 9.78 90 130343 13872 70784139
Neutropenia 48.43 9.78 276 130157 256880 70541131
Sleep disorder due to general medical condition, insomnia type 47.84 9.78 5 130428 35727 70762284
Constipation 47.50 9.78 271 130162 252167 70545844
Myasthenia gravis crisis 47.36 9.78 27 130406 974 70797037
Cystic fibrosis related diabetes 46.95 9.78 17 130416 203 70797808
Dehydration 46.86 9.78 235 130198 225907 70572104
Stenotrophomonas infection 46.73 9.78 43 130390 3306 70794705
Mucocutaneous disorder 46.34 9.78 15 130418 124 70797887
Total lung capacity increased 46.08 9.78 26 130407 919 70797092
Chest discomfort 45.87 9.78 388 130045 123993 70674018
Distal intestinal obstruction syndrome 45.29 9.78 23 130410 655 70797356
Discomfort 44.92 9.78 78 130355 105358 70692653
Pulmonary embolism 44.82 9.78 461 129972 155406 70642605
Lung transplant rejection 44.19 9.78 29 130404 1351 70796660
Hypertriglyceridaemia 43.45 9.78 78 130355 11733 70786278
Actinic keratosis 42.58 9.78 52 130381 5538 70792473
Babesiosis 42.21 9.78 18 130415 340 70797671
Respiration abnormal 41.56 9.78 57 130376 6807 70791204
Blood pressure fluctuation 41.27 9.78 29 130404 58983 70739028
Cognitive disorder 41.27 9.78 31 130402 60925 70737086
Lung opacity 41.13 9.78 42 130391 3671 70794340
Hepatocellular injury 41.12 9.78 181 130252 45910 70752101
Dizziness 40.90 9.78 604 129829 463537 70334474
Hepatitis cholestatic 40.86 9.78 79 130354 12571 70785440
Urinary tract infection 40.63 9.78 279 130154 248490 70549521
Hypofibrinogenaemia 40.07 9.78 31 130402 1876 70796135
Eosinophilic pneumonia 39.61 9.78 47 130386 4858 70793153
Impaired healing 39.60 9.78 47 130386 74327 70723684
Bronchomalacia 39.47 9.78 15 130418 207 70797804
Bronchiolitis obliterans syndrome 39.28 9.78 16 130417 268 70797743
Injection site pain 39.20 9.78 100 130333 117519 70680492
Pneumomediastinum 38.94 9.78 39 130394 3331 70794680
Anosmia 38.14 9.78 46 130387 4837 70793174
Contusion 38.10 9.78 115 130318 127921 70670090
Auscultation 37.10 9.78 7 130426 0 70798011
Irritable bowel syndrome 36.89 9.78 24 130409 50826 70747185
Pulmonary function test abnormal 36.60 9.78 38 130395 3387 70794624
Eosinophil count increased 36.31 9.78 84 130349 15138 70782873
Gastrointestinal haemorrhage 35.68 9.78 131 130302 137277 70660734
Hepatic enzyme increased 34.92 9.78 159 130274 156831 70641180
Heart sounds 34.74 9.78 20 130413 735 70797276
General physical health deterioration 34.56 9.78 273 130160 235758 70562253
Pregnancy 34.30 9.78 109 130324 23672 70774339
Forced expiratory volume 34.19 9.78 11 130422 89 70797922
Gallbladder disorder 34.06 9.78 90 130343 17622 70780389
Cholestasis 33.99 9.78 176 130257 47696 70750315
Sedation 33.98 9.78 22 130411 46709 70751302
HIV associated nephropathy 33.81 9.78 15 130418 313 70797698
Prostate cancer 33.56 9.78 8 130425 31155 70766856
Symmetrical drug-related intertriginous and flexural exanthema 33.23 9.78 19 130414 689 70797322
Graft versus host disease in lung 33.21 9.78 20 130413 800 70797211
Parathyroid gland enlargement 33.17 9.78 12 130421 143 70797868
Atypical mycobacterial infection 33.17 9.78 25 130408 1455 70796556
Tinnitus 32.98 9.78 143 130290 36033 70761978
Decreased appetite 32.93 9.78 380 130053 304400 70493611
Rales 32.88 9.78 87 130346 17048 70780963
Immunodeficiency common variable 32.76 9.78 14 130419 266 70797745
Herpes simplex viraemia 32.71 9.78 14 130419 267 70797744
Chronic sinusitis 32.62 9.78 57 130376 8394 70789617
Cryptococcosis 32.31 9.78 35 130398 3275 70794736
Respiratory tract infection 32.30 9.78 159 130274 42239 70755772
Respiratory disorder 32.18 9.78 150 130283 38973 70759038
Mucormycosis 32.18 9.78 55 130378 7959 70790052
Abdominal discomfort 32.02 9.78 247 130186 214411 70583600
Injection site erythema 31.93 9.78 53 130380 72871 70725140
Myocardial infarction 31.87 9.78 185 130248 171460 70626551
Injection site swelling 31.81 9.78 20 130413 43137 70754874
Hyponatraemia 31.65 9.78 169 130264 159918 70638093
Hypotension 31.65 9.78 538 129895 403843 70394168
Osteonecrosis of jaw 31.63 9.78 18 130415 40984 70757027
Atypical mycobacterial lower respiratory tract infection 31.63 9.78 10 130423 76 70797935
Viral infection 31.43 9.78 147 130286 38244 70759767
Pain 31.29 9.78 899 129534 627917 70170094
Pneumonia legionella 30.92 9.78 31 130402 2651 70795360
Influenza 30.66 9.78 332 130101 113368 70684643
Pneumothorax spontaneous 30.64 9.78 23 130410 1330 70796681
Pain in extremity 30.61 9.78 422 130011 327660 70470351
Cryptococcal meningoencephalitis 30.51 9.78 13 130420 245 70797766
Palmar-plantar erythrodysaesthesia syndrome 30.24 9.78 9 130424 30238 70767773
Deafness neurosensory 29.97 9.78 48 130385 6584 70791427
Prolonged expiration 29.70 9.78 20 130413 973 70797038
Cystic fibrosis pancreatic 29.61 9.78 9 130424 59 70797952
Oral candidiasis 29.50 9.78 107 130326 24845 70773166
Pneumonia pseudomonal 29.43 9.78 42 130391 5204 70792807
Orthostatic hypotension 29.40 9.78 31 130402 51712 70746299
Hypercapnia 29.37 9.78 54 130379 8275 70789736
Middle lobe syndrome 29.20 9.78 8 130425 34 70797977
Blood pressure increased 29.02 9.78 215 130218 188302 70609709
Mycobacterium chelonae infection 28.50 9.78 28 130405 2336 70795675
Cytokine storm 28.44 9.78 19 130414 912 70797099
Sopor 28.31 9.78 11 130422 31256 70766755
Pharyngeal erythema 28.07 9.78 25 130408 1842 70796169
Hospitalisation 28.05 9.78 253 130180 82315 70715696
Disease progression 27.96 9.78 171 130262 156501 70641510
Mixed liver injury 27.92 9.78 45 130388 6204 70791807
Neutrophil count decreased 27.10 9.78 72 130361 83484 70714527
Breast cancer 26.94 9.78 14 130419 33535 70764476
NPM1 gene mutation 26.85 9.78 10 130423 130 70797881
Hypokalaemia 26.77 9.78 137 130296 131051 70666960
Factor V deficiency 26.56 9.78 9 130424 87 70797924
Liver function test increased 26.55 9.78 128 130305 33719 70764292
Knee arthroplasty 26.54 9.78 15 130418 34286 70763725
Pneumonia bacterial 26.53 9.78 79 130354 16562 70781449
Therapeutic product effect incomplete 26.53 9.78 337 130096 119545 70678466
Cardiac failure 26.49 9.78 155 130278 143386 70654625
Seizure 26.43 9.78 205 130228 177757 70620254
Disseminated mycobacterium avium complex infection 26.38 9.78 11 130422 196 70797815
SJS-TEN overlap 26.34 9.78 15 130418 540 70797471
Lung diffusion disorder 26.31 9.78 10 130423 138 70797873
Gait disturbance 26.21 9.78 216 130217 184890 70613121
Platelet count decreased 26.14 9.78 206 130227 178016 70619995
Cardiac arrest 26.09 9.78 426 130007 159408 70638603
Cystic fibrosis lung 26.05 9.78 10 130423 142 70797869
Aspartate aminotransferase increased 26.03 9.78 352 130081 126626 70671385
Agranulocytosis 25.79 9.78 144 130289 40154 70757857
Dysarthria 25.72 9.78 47 130386 62266 70735745
C-reactive protein abnormal 25.63 9.78 20 130413 38559 70759452
Genital ulceration 25.63 9.78 16 130417 683 70797328
Metastases to bone 25.61 9.78 5 130428 22371 70775640
Rash maculo-papular 25.61 9.78 170 130263 50375 70747636
Adverse event 25.54 9.78 32 130401 49429 70748582
Metastases to liver 25.33 9.78 8 130425 25870 70772141
Rash maculovesicular 25.32 9.78 7 130426 31 70797980
Blood immunoglobulin E increased 25.19 9.78 37 130396 4707 70793304
Alveolitis 25.14 9.78 33 130400 3778 70794233
Mechanical urticaria 25.13 9.78 13 130420 385 70797626
Forced vital capacity decreased 25.10 9.78 22 130411 1587 70796424
Joint stiffness 24.98 9.78 17 130416 35159 70762852
Lung infiltration 24.95 9.78 92 130341 21532 70776479
Methaemoglobinaemia 24.94 9.78 37 130396 4749 70793262
Upper respiratory fungal infection 24.70 9.78 12 130421 310 70797701
Blister 24.70 9.78 98 130335 100428 70697583
Tachyarrhythmia 24.58 9.78 43 130390 6339 70791672
Oropharyngeal pain 24.49 9.78 278 130155 96032 70701979
Cholelithiasis 24.46 9.78 160 130273 47180 70750831
Asthenia 24.09 9.78 649 129784 457017 70340994
Headache 23.99 9.78 850 129583 579555 70218456
Endometritis 23.93 9.78 16 130417 769 70797242
Joint range of motion decreased 23.83 9.78 9 130424 26017 70771994
Respiratory syncytial virus infection 23.74 9.78 47 130386 7608 70790403
Accidental exposure to product 23.59 9.78 11 130422 28040 70769971
Depressed level of consciousness 23.59 9.78 82 130351 87349 70710662
Complications of transplanted lung 23.55 9.78 13 130420 440 70797571
Urethritis mycoplasmal 23.52 9.78 6 130427 18 70797993
White blood cell count decreased 23.43 9.78 200 130233 169941 70628070
Device expulsion 23.40 9.78 6 130427 22240 70775771
Pneumonia mycoplasmal 23.32 9.78 20 130413 1401 70796610
Conjunctival hyperaemia 23.31 9.78 33 130400 4060 70793951
Total lung capacity decreased 23.14 9.78 23 130410 1946 70796065
Mucosal inflammation 23.13 9.78 57 130376 67793 70730218
Bronchial wall thickening 22.97 9.78 24 130409 2155 70795856
Tachypnoea 22.97 9.78 109 130324 28529 70769482
Iris transillumination defect 22.94 9.78 9 130424 136 70797875
Sputum retention 22.83 9.78 17 130416 971 70797040
Chlamydial infection 22.72 9.78 13 130420 472 70797539
Ventricular tachycardia 22.54 9.78 129 130304 36294 70761717
Treatment failure 22.37 9.78 164 130269 143978 70654033
Lung transplant 22.12 9.78 33 130400 4257 70793754
Pancreatic failure 22.11 9.78 20 130413 1504 70796507
Rhinocerebral mucormycosis 22.07 9.78 15 130418 741 70797270
Injection site reaction 22.04 9.78 36 130397 49816 70748195
Pharyngeal enanthema 21.83 9.78 7 130426 56 70797955
Uterine perforation 21.79 9.78 39 130394 5852 70792159
Bladder cancer 21.64 9.78 3 130430 17239 70780772
Folliculitis 21.51 9.78 28 130405 42542 70755469
Upper-airway cough syndrome 21.37 9.78 52 130381 9679 70788332
Injection site bruising 21.37 9.78 23 130410 38009 70760002
Chronic kidney disease 21.21 9.78 188 130245 60869 70737142
Hyperbilirubinaemia 21.18 9.78 90 130343 22478 70775533
Lung disorder 21.15 9.78 208 130225 69276 70728735
Hypertension 20.88 9.78 401 130032 295632 70502379
Emphysema 20.78 9.78 68 130365 14992 70783019
Pelvic inflammatory disease 20.78 9.78 18 130415 1278 70796733
Urticaria 20.77 9.78 418 130015 162631 70635380
Flank pain 20.64 9.78 75 130358 17427 70780584
Bacterial infection 20.64 9.78 100 130333 26392 70771619
Bacterial pericarditis 20.45 9.78 7 130426 70 70797941
Rheumatoid factor 20.26 9.78 8 130425 123 70797888
Small intestinal obstruction 20.23 9.78 10 130423 24645 70773366
Cerebral infarction 20.02 9.78 30 130403 42979 70755032
Therapeutic response decreased 20.01 9.78 49 130384 58404 70739607
Injection site haemorrhage 19.99 9.78 11 130422 25516 70772495
Chimerism 19.78 9.78 10 130423 282 70797729
Hallucinations, mixed 19.66 9.78 39 130394 6323 70791688
Balance disorder 19.61 9.78 92 130341 90036 70707975
Granulomatosis with polyangiitis 19.49 9.78 24 130409 2578 70795433
Anhedonia 19.46 9.78 64 130369 14149 70783862
Dystonia 19.45 9.78 6 130427 19700 70778311
Psoriatic arthropathy 19.39 9.78 58 130375 64713 70733298
Meningism 19.29 9.78 13 130420 633 70797378
Fungal disease carrier 19.22 9.78 10 130423 300 70797711
Jarisch-Herxheimer reaction 19.17 9.78 14 130419 776 70797235
Ascites 19.15 9.78 62 130371 67485 70730526
Gastrooesophageal reflux disease 19.10 9.78 253 130180 90586 70707425
Amniotic cavity infection 18.81 9.78 14 130419 799 70797212
Erythema multiforme 18.71 9.78 70 130363 16494 70781517
Drug level increased 18.68 9.78 123 130310 36346 70761665
Pneumonia necrotising 18.55 9.78 15 130418 968 70797043
Antinuclear antibody negative 18.49 9.78 5 130428 20 70797991
Pneumonia aspiration 18.48 9.78 56 130377 62233 70735778
Tubulointerstitial nephritis 18.45 9.78 114 130319 32962 70765049
Andersen-Tawil syndrome 18.44 9.78 4 130429 4 70798007
Gallbladder cholesterolosis 18.38 9.78 12 130421 554 70797457
Pancreatitis acute 18.23 9.78 144 130289 45080 70752931
Lung hyperinflation 18.22 9.78 19 130414 1702 70796309
Multiple sclerosis relapse 18.15 9.78 32 130401 42985 70755026
Weight increased 18.10 9.78 325 130108 242006 70556005
Fracture 18.09 9.78 7 130426 19937 70778074
Pseudomembranous colitis 17.85 9.78 33 130400 5078 70792933
Nasal mucosal disorder 17.84 9.78 10 130423 349 70797662
Respiratory distress 17.82 9.78 166 130267 54484 70743527
Restrictive allograft syndrome 17.76 9.78 5 130428 24 70797987
Disseminated cryptococcosis 17.63 9.78 19 130414 1768 70796243
Dyspnoea exertional 17.57 9.78 221 130212 78209 70719802
Urethral discharge 17.55 9.78 4 130429 6 70798005
Foot deformity 17.53 9.78 8 130425 20647 70777364
Heart rate decreased 17.52 9.78 57 130376 61958 70736053
Leukocytosis 17.50 9.78 129 130304 39539 70758472
HIV infection 17.49 9.78 17 130416 1400 70796611
Pyrexia 17.40 9.78 1318 129115 605634 70192377
Hepatomegaly 17.39 9.78 71 130362 17421 70780590
Rhodococcus infection 17.39 9.78 9 130424 267 70797744
Hypoglycaemia 17.35 9.78 102 130331 94262 70703749
Malignant melanoma in situ 17.31 9.78 20 130413 2009 70796002
Crystal arthropathy 17.20 9.78 8 130425 187 70797824
Carbon dioxide increased 17.19 9.78 20 130413 2025 70795986
Pulmonary infarction 17.17 9.78 26 130407 3397 70794614
Vaginal stricture 17.17 9.78 4 130429 7 70798004
Joint dislocation 17.16 9.78 3 130430 14528 70783483
Red blood cell sedimentation rate abnormal 17.14 9.78 7 130426 19296 70778715
Muscular weakness 17.13 9.78 167 130266 138169 70659842
Respiratory tract congestion 17.03 9.78 71 130362 17582 70780429
Musculoskeletal pain 16.95 9.78 97 130336 90230 70707781
Gastroenteritis staphylococcal 16.91 9.78 9 130424 283 70797728
Enterovirus infection 16.89 9.78 18 130415 1653 70796358
Infective chondritis 16.83 9.78 5 130428 30 70797981
Anaemia 16.82 9.78 590 129843 402833 70395178
Fluid retention 16.73 9.78 60 130373 63325 70734686
Lip erythema 16.56 9.78 8 130425 204 70797807
Osteoarthritis 16.54 9.78 75 130358 74072 70723939
Fibromyalgia 16.49 9.78 40 130393 47834 70750177
Gallbladder injury 16.48 9.78 15 130418 1137 70796874
Pneumonia staphylococcal 16.45 9.78 30 130403 4568 70793443
Urosepsis 16.44 9.78 12 130421 23937 70774074
Staphylococcal infection 16.32 9.78 160 130273 53244 70744767
Interstitial lung disease 16.29 9.78 119 130314 104566 70693445
Kawasaki's disease 16.21 9.78 4 130429 10 70798001
Cardiac failure congestive 16.16 9.78 165 130268 135292 70662719
Muscle spasticity 16.13 9.78 8 130425 19681 70778330
HIV viraemia 16.11 9.78 6 130427 78 70797933
C-reactive protein increased 16.08 9.78 128 130305 110389 70687622
Mycoplasma infection 16.06 9.78 12 130421 689 70797322
Appetite disorder 16.03 9.78 38 130395 6957 70791054
Poisoning 15.97 9.78 11 130422 22611 70775400
Thoracic cavity drainage test abnormal 15.90 9.78 3 130430 0 70798011
Bronchogram abnormal 15.90 9.78 3 130430 0 70798011
Portal hypertensive enteropathy 15.90 9.78 3 130430 0 70798011
Noninfective conjunctivitis 15.81 9.78 5 130428 38 70797973
Haemolysis 15.80 9.78 52 130381 11499 70786512
Gait inability 15.79 9.78 40 130393 47135 70750876
Prescribed overdose 15.76 9.78 16 130417 27165 70770846
Hip arthroplasty 15.71 9.78 17 130416 28023 70769988
Diabetic ketoacidosis 15.64 9.78 21 130412 31491 70766520
Blood immunoglobulin G decreased 15.64 9.78 23 130410 2929 70795082
Staphylococcus test positive 15.48 9.78 34 130399 5920 70792091
Lower gastrointestinal haemorrhage 15.42 9.78 4 130429 14716 70783295
Bacterial disease carrier 15.23 9.78 14 130419 1075 70796936
Basal cell carcinoma 15.21 9.78 24 130409 33674 70764337
Pigment nephropathy 15.17 9.78 5 130428 44 70797967
Subcutaneous emphysema 15.06 9.78 17 130416 1665 70796346
Hepatotoxicity 15.05 9.78 135 130298 43851 70754160
Peak expiratory flow rate abnormal 14.87 9.78 6 130427 98 70797913
Impaired quality of life 14.86 9.78 43 130390 8873 70789138
Macule 14.84 9.78 21 130412 2582 70795429
Purpura 14.84 9.78 69 130364 17906 70780105
Increased bronchial secretion 14.82 9.78 23 130410 3070 70794941
Hyperaemia 14.80 9.78 22 130411 2829 70795182
Extrapyramidal disorder 14.77 9.78 10 130423 20740 70777271
Rheumatic fever 14.74 9.78 7 130426 17653 70780358
Abdominal wall haematoma 14.72 9.78 28 130405 4402 70793609
Bronchial hyperreactivity 14.70 9.78 21 130412 2605 70795406
Nosocomial infection 14.65 9.78 21 130412 2612 70795399
Blood glucose increased 14.65 9.78 120 130313 102862 70695149
Rash pustular 14.64 9.78 47 130386 10261 70787750
Gonorrhoea 14.62 9.78 7 130426 175 70797836
Pancreatic carcinoma 14.53 9.78 3 130430 12901 70785110
Kounis syndrome 14.48 9.78 24 130409 3387 70794624
Oral mucosa erosion 14.40 9.78 17 130416 1748 70796263
Clostridium difficile colitis 14.37 9.78 97 130336 28899 70769112
Hyperkalaemia 14.35 9.78 126 130307 106465 70691546
Psoriasis 14.32 9.78 114 130319 98319 70699692
Acoustic neuroma 14.30 9.78 8 130425 278 70797733
Total lung capacity abnormal 14.30 9.78 7 130426 184 70797827
Respiratory tract inflammation 14.21 9.78 12 130421 823 70797188
Cerebral haemorrhage 14.21 9.78 51 130382 53813 70744198
Hypogammaglobulinaemia 14.08 9.78 50 130383 11488 70786523
Blood pressure diastolic decreased 14.03 9.78 16 130417 25764 70772247
Injection site warmth 14.03 9.78 4 130429 13821 70784190
Oesophagogastroduodenoscopy 14.02 9.78 7 130426 192 70797819
Hilar lymphadenopathy 14.01 9.78 16 130417 1587 70796424
Alcohol intolerance 13.97 9.78 9 130424 406 70797605
Respiratory depression 13.97 9.78 15 130418 24816 70773195
Pneumonia pneumococcal 13.95 9.78 24 130409 3490 70794521
Local reaction 13.92 9.78 10 130423 540 70797471
Severe acute respiratory syndrome 13.90 9.78 6 130427 117 70797894
Bronchial secretion retention 13.89 9.78 22 130411 2988 70795023
Disorientation 13.89 9.78 57 130376 57866 70740145
Device malfunction 13.85 9.78 9 130424 19075 70778936
Senile pruritus 13.83 9.78 3 130430 3 70798008
Myasthenia gravis 13.81 9.78 37 130396 7302 70790709
Hepatic necrosis 13.74 9.78 41 130392 8605 70789406
Mycoplasma test positive 13.67 9.78 7 130426 203 70797808
Intentional product misuse 13.61 9.78 88 130345 79507 70718504
Catastrophic reaction 13.61 9.78 4 130429 23 70797988
Rhinorrhoea 13.60 9.78 184 130249 66187 70731824
Status epilepticus 13.59 9.78 15 130418 24511 70773500
Pulmonary alveolar haemorrhage 13.58 9.78 46 130387 10323 70787688
Delusional disorder, persecutory type 13.57 9.78 9 130424 427 70797584
Arthritis 13.56 9.78 115 130318 97865 70700146
Type 2 diabetes mellitus 13.53 9.78 39 130394 44041 70753970
Asthmatic crisis 13.51 9.78 17 130416 1867 70796144
Pleural fistula 13.46 9.78 4 130429 24 70797987
Dyshidrotic eczema 13.45 9.78 10 130423 570 70797441
Bronchial disorder 13.43 9.78 19 130414 2335 70795676
End stage renal disease 13.38 9.78 48 130385 11085 70786926
Herpes zoster 13.21 9.78 97 130336 85138 70712873
Interleukin level increased 13.20 9.78 9 130424 447 70797564
Neoplasm progression 13.18 9.78 41 130392 45187 70752824
Leukaemoid reaction 13.17 9.78 8 130425 325 70797686
Sinus congestion 13.12 9.78 65 130368 17308 70780703
Acute sinusitis 13.11 9.78 26 130407 4215 70793796
Adverse drug reaction 13.10 9.78 52 130381 53292 70744719
Back pain 13.09 9.78 389 130044 270763 70527248
Skin ulcer 13.09 9.78 45 130388 48100 70749911
Sarcoidosis 13.07 9.78 34 130399 6593 70791418
Febrile bone marrow aplasia 13.07 9.78 3 130430 11988 70786023
Nocardiosis 13.01 9.78 29 130404 5100 70792911
Poor feeding infant 12.99 9.78 6 130427 138 70797873
Dysbiosis 12.94 9.78 12 130421 932 70797079
Haemorrhoids thrombosed 12.93 9.78 7 130426 228 70797783
Laryngeal mass 12.90 9.78 5 130428 73 70797938
Q fever 12.90 9.78 7 130426 229 70797782
Second primary malignancy 12.83 9.78 4 130429 13047 70784964
Infusion site streaking 12.83 9.78 9 130424 468 70797543
Occupational exposure to air contaminants 12.79 9.78 6 130427 143 70797868
Multiple-drug resistance 12.77 9.78 36 130397 7319 70790692
Diverticulitis 12.76 9.78 37 130396 41697 70756314
Renal injury 12.72 9.78 61 130372 16033 70781978
Miosis 12.70 9.78 5 130428 14096 70783915
Sinusitis 12.69 9.78 404 130029 168791 70629220
Humidity intolerance 12.68 9.78 8 130425 348 70797663
Pneumonia acinetobacter 12.64 9.78 6 130427 147 70797864
Nasal congestion 12.62 9.78 180 130253 65492 70732519
Altered state of consciousness 12.59 9.78 35 130398 39987 70758024
Pulmonary vasculitis 12.56 9.78 9 130424 484 70797527
Deafness unilateral 12.56 9.78 24 130409 3785 70794226
Maternal exposure during pregnancy 12.53 9.78 289 130144 115056 70682955
Lemierre syndrome 12.49 9.78 6 130427 151 70797860
Chest X-ray abnormal 12.44 9.78 35 130398 7109 70790902
Haematemesis 12.35 9.78 47 130386 48750 70749261
Liver function test 12.31 9.78 6 130427 156 70797855
Eye swelling 12.31 9.78 80 130353 23534 70774477
Depressed mood 12.29 9.78 129 130304 43691 70754320
Pain in jaw 12.21 9.78 39 130394 42630 70755381
Cerebral toxoplasmosis 12.18 9.78 17 130416 2063 70795948
Head injury 12.18 9.78 28 130405 34113 70763898
Pneumopericardium 12.18 9.78 6 130427 160 70797851
Bulimia nervosa 12.17 9.78 7 130426 257 70797754
Sensory loss 12.16 9.78 3 130430 11416 70786595
Hepatosplenomegaly 12.13 9.78 30 130403 5640 70792371
Multiple organ dysfunction syndrome 12.13 9.78 273 130160 108242 70689769
Normal newborn 12.10 9.78 32 130401 6268 70791743
Borderline personality disorder 12.07 9.78 11 130422 835 70797176
Neurological examination abnormal 12.04 9.78 9 130424 517 70797494
ADAMTS13 activity decreased 12.04 9.78 6 130427 164 70797847
Inappropriate schedule of product administration 12.02 9.78 133 130300 107422 70690589
Inguinal hernia repair 12.00 9.78 7 130426 264 70797747
Localised infection 11.99 9.78 27 130406 33131 70764880
Muscle rigidity 11.97 9.78 10 130423 18640 70779371
Lethargy 11.97 9.78 85 130348 75165 70722846
Palatal oedema 11.93 9.78 13 130420 1225 70796786
Ruptured ectopic pregnancy 11.88 9.78 8 130425 389 70797622
Syphilis 11.88 9.78 9 130424 528 70797483
Infection reactivation 11.87 9.78 18 130415 2355 70795656
Paraesthesia oral 11.87 9.78 58 130375 15359 70782652
Ventricular fibrillation 11.86 9.78 88 130345 27023 70770988
Procedural anxiety 11.86 9.78 10 130423 684 70797327
Hemianopia heteronymous 11.80 9.78 5 130428 93 70797918
Hypo HDL cholesterolaemia 11.76 9.78 3 130430 9 70798002
Diffuse panbronchiolitis 11.76 9.78 3 130430 9 70798002
Dizziness exertional 11.74 9.78 9 130424 537 70797474
Rhinovirus infection 11.73 9.78 33 130400 6700 70791311
Cheilitis 11.73 9.78 27 130406 4850 70793161
Secretion discharge 11.69 9.78 51 130382 12882 70785129
Cystic fibrosis hepatic disease 11.68 9.78 4 130429 40 70797971
Coinfection 11.68 9.78 4 130429 40 70797971
Deep vein thrombosis 11.68 9.78 277 130156 110765 70687246
Biopsy colon abnormal 11.65 9.78 5 130428 96 70797915
Coronavirus test positive 11.62 9.78 12 130421 1063 70796948
Injection site mass 11.58 9.78 10 130423 18333 70779678
Skin disorder 11.57 9.78 24 130409 30333 70767678
Loss of consciousness 11.56 9.78 209 130224 155507 70642504
Stomatococcal infection 11.53 9.78 7 130426 284 70797727
Atypical mycobacterium test positive 11.52 9.78 3 130430 10 70798001
CD4 lymphocytes increased 11.51 9.78 7 130426 285 70797726
Veillonella infection 11.51 9.78 4 130429 42 70797969
Plasma cell myeloma 11.49 9.78 83 130350 73118 70724893
Multiple sclerosis 11.42 9.78 18 130415 25267 70772744
Haemolytic anaemia 11.41 9.78 61 130372 16733 70781278
Underdose 11.39 9.78 23 130410 29360 70768651
Suicidal ideation 11.37 9.78 78 130355 69518 70728493
Myelosuppression 11.35 9.78 24 130409 30121 70767890
Anal skin tags 11.34 9.78 8 130425 420 70797591
Toxic optic neuropathy 11.33 9.78 12 130421 1094 70796917
Macular degeneration 11.31 9.78 35 130398 7493 70790518
Foetal death 11.29 9.78 31 130402 6208 70791803
Vascular parkinsonism 11.28 9.78 5 130428 104 70797907
Red blood cell sedimentation rate increased 11.28 9.78 35 130398 38607 70759404
Hypersensitivity 11.27 9.78 329 130104 229483 70568528
Ill-defined disorder 11.25 9.78 57 130376 54684 70743327
Urinary incontinence 11.24 9.78 34 130399 37808 70760203
Virologic failure 11.18 9.78 23 130410 3827 70794184
Immunosuppressant drug level increased 11.18 9.78 36 130397 7871 70790140
Bronchospasm 11.15 9.78 76 130357 22716 70775295
Eosinophilic pleural effusion 11.11 9.78 7 130426 304 70797707
Neurilemmoma benign 11.10 9.78 3 130430 12 70797999
Papillary muscle rupture 11.10 9.78 3 130430 12 70797999
Blood alkaline phosphatase increased 11.08 9.78 160 130273 58361 70739650
Hip fracture 11.06 9.78 22 130411 28241 70769770
Disturbance in attention 11.06 9.78 41 130392 42853 70755158
Eosinophilic pustular folliculitis 10.99 9.78 5 130428 111 70797900
Acute kidney injury 10.93 9.78 1014 129419 473610 70324401
Laryngeal pain 10.90 9.78 29 130404 5699 70792312
Product prescribing error 10.87 9.78 36 130397 38916 70759095
Presyncope 10.86 9.78 34 130399 37404 70760607
Rash erythematous 10.85 9.78 144 130289 51574 70746437
Anxiety 10.78 9.78 502 129931 219828 70578183
Chest pain 10.74 9.78 565 129868 250695 70547316
Ectopic pregnancy 10.73 9.78 14 130419 1594 70796417
Enanthema 10.71 9.78 10 130423 783 70797228
Gallbladder hypofunction 10.71 9.78 8 130425 459 70797552
Angina bullosa haemorrhagica 10.64 9.78 6 130427 212 70797799
Glucose tolerance impaired 10.56 9.78 32 130401 6774 70791237
Conjunctivochalasis 10.55 9.78 3 130430 15 70797996
Pneumonia serratia 10.55 9.78 3 130430 15 70797996
Toothache 10.52 9.78 11 130422 18419 70779592
Bronchopleural fistula 10.51 9.78 9 130424 629 70797382
Interleukin-2 receptor increased 10.51 9.78 6 130427 217 70797794
Haemoglobin decreased 10.49 9.78 292 130141 204867 70593144
Nail pitting 10.48 9.78 7 130426 336 70797675
Bone density decreased 10.45 9.78 4 130429 11470 70786541
Ischaemic stroke 10.42 9.78 26 130407 30794 70767217
Ureteric perforation 10.39 9.78 3 130430 16 70797995
Graft infection 10.37 9.78 9 130424 641 70797370
Linear IgA disease 10.36 9.78 19 130414 2905 70795106
Hypoaesthesia 10.30 9.78 210 130223 153529 70644482
Hepatocellular carcinoma 10.27 9.78 3 130430 10205 70787806
Glucose-6-phosphate dehydrogenase deficiency 10.26 9.78 7 130426 348 70797663
Wrong technique in product usage process 10.25 9.78 79 130354 68619 70729392
Loss of personal independence in daily activities 10.25 9.78 216 130217 84694 70713317
Nodule 10.22 9.78 13 130420 19956 70778055
Mediastinal shift 10.22 9.78 4 130429 60 70797951
Drug screen false positive 10.22 9.78 11 130422 1022 70796989
Anticoagulation drug level above therapeutic 10.19 9.78 20 130413 3218 70794793
Interstitial granulomatous dermatitis 10.17 9.78 6 130427 231 70797780
Bronchiolitis 10.16 9.78 22 130411 3792 70794219
Rotavirus infection 10.15 9.78 9 130424 659 70797352
Epidermolysis 10.14 9.78 8 130425 498 70797513
Autoimmune hepatitis 10.11 9.78 43 130390 10743 70787268
Vaginal abscess 10.08 9.78 7 130426 358 70797653
Benign prostatic hyperplasia 10.07 9.78 42 130391 10401 70787610
Akathisia 10.06 9.78 5 130428 12288 70785723
Dry mouth 10.06 9.78 82 130351 70375 70727636
Superinfection bacterial 10.02 9.78 12 130421 1252 70796759
Cytokine release syndrome 10.02 9.78 21 130412 26446 70771565
Opportunistic infection 9.98 9.78 18 130415 2718 70795293
Abortion spontaneous 9.96 9.78 83 130350 26396 70771615
Legionella test positive 9.96 9.78 3 130430 19 70797992
Tooth discolouration 9.93 9.78 11 130422 1056 70796955
Transfusion 9.92 9.78 12 130421 18824 70779187
Squamous cell carcinoma of skin 9.91 9.78 48 130385 12664 70785347
Kidney transplant rejection 9.89 9.78 3 130430 9958 70788053
Prescribed underdose 9.87 9.78 15 130418 21370 70776641
Sinus operation 9.84 9.78 15 130418 1972 70796039
Atrial conduction time prolongation 9.83 9.78 3 130430 20 70797991

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01FA10 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
Macrolides
ATC J01RA07 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC S01AA26 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Antibiotics
FDA CS M0028311 Macrolides
FDA Chemical/Ingredient N0000007529 Macrolides
FDA EPC N0000175935 Macrolide Antimicrobial
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents

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

DiseaseRelationSNOMED_IDDOID
Acute gonococcal cervicitis indication 20943002 DOID:10615
Acute gonococcal urethritis indication 29864006
Bacterial blepharitis indication 41446000 DOID:9423
Streptococcal tonsillitis indication 41582007
Pneumonia due to Mycoplasma pneumoniae indication 46970008
Bacterial pneumonia indication 53084003 DOID:874
Haemophilus influenzae pneumonia indication 70036007
Acute bacterial sinusitis indication 75498004
Dacryocystitis indication 85777005 DOID:9938
Bacterial conjunctivitis indication 128350005 DOID:9700
Urethritis due to Chlamydia trachomatis indication 179101003
Pulmonary Mycobacterium avium complex infection indication 186342000
Chlamydial pelvic inflammatory disease indication 188463006
Acute bacterial bronchitis indication 233598009
Pneumococcal pneumonia indication 233607000
Chlamydial pneumonia indication 233609002
Chancroid indication 266143009 DOID:13778
Pelvic inflammatory disease due to Mycoplasma hominis indication 270550006
Streptococcus pyogenes infection indication 302809008
Infective otitis media indication 312218008
Bacterial hordeolum indication 397513003 DOID:9909
Infection due to Staphylococcus aureus indication 406602003
Acute exacerbation of chronic bronchitis indication 425748003
Pneumonia due to Staphylococcus aureus indication 441658007
Haemophilus Influenzae Acute Otitis Media indication
Pneumococcal Acute Otitis Media indication
Skin and Skin Structure Streptococcus Agalactiae Infection indication
Pelvic Inflammatory Disease with Neisseria Gonorrhea indication
Legionella Pneumophila Pneumonia indication
Moraxella Catarrhalis Pneumonia indication
Chlamydia Cervicitis indication
Moraxella Catarrhalis Acute Otitis Media indication
Pyrexia of unknown origin off-label use 7520000
Traveler's diarrhea off-label use 11840006
Enteric campylobacteriosis off-label use 18081009
Pertussis off-label use 27836007
Gonorrhea of rectum off-label use 42746002
Gonorrhea of pharynx off-label use 74372003
Coronavirus infection off-label use 186747009
Boutonneuse fever off-label use 186774005 DOID:14095
Toxoplasmosis associated with acquired immunodeficiency syndrome off-label use 421666009
Prevention of Bacterial Endocarditis off-label use
Sexual Transmitted Disease Exposure from Sexual Assault off-label use
Inflammatory Disease of Female Pelvic Organs off-label use
Jaundice contraindication 18165001
Torsades de pointes contraindication 31722008
Chronic heart failure contraindication 48447003
Myasthenia gravis contraindication 91637004 DOID:437
Prolonged QT interval contraindication 111975006
Hearing disorder contraindication 128540005
Liver function tests abnormal contraindication 166603001
Disease of liver contraindication 235856003 DOID:409
Pseudomembranous enterocolitis contraindication 397683000
Congenital long QT syndrome contraindication 442917000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.45 acidic
pKa2 8.87 Basic
pKa3 8.24 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 2GM BASE/BOT ZMAX PF PRISM CV N050797 June 10, 2005 DISCN FOR SUSPENSION, EXTENDED RELEASE ORAL 6984403 Feb. 14, 2024 METHOD OF TREATING BACTERIAL INFECTIONS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 3.39 WOMBAT-PK
Multidrug resistance protein 1 Transporter IC50 3.70 WOMBAT-PK
Canalicular multispecific organic anion transporter 1 Transporter IC50 4.16 WOMBAT-PK
Motilin receptor GPCR AGONIST EC50 5.50 IUPHAR

External reference:

IDSource
4020019 VUID
N0000148074 NUI
D02134 KEGG_DRUG
121470-24-4 SECONDARY_CAS_RN
117772-70-0 SECONDARY_CAS_RN
1298839 RXNORM
4020019 VANDF
4020964 VANDF
C0052796 UMLSCUI
ZIT PDB_CHEM_ID
CHEMBL529 ChEMBL_ID
CHEMBL1200502 ChEMBL_ID
D017963 MESH_DESCRIPTOR_UI
DB00207 DRUGBANK_ID
6510 IUPHAR_LIGAND_ID
447043 PUBCHEM_CID
4238 MMSL
72442 MMSL
d00091 MMSL
003635 NDDF
387531004 SNOMEDCT_US
391805000 SNOMEDCT_US
734459003 SNOMEDCT_US
785687007 SNOMEDCT_US
96034006 SNOMEDCT_US
6197 INN_ID
JTE4MNN1MD UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-0400 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS NDA 29 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-0400 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS NDA 29 sections
ZITHROMAX HUMAN PRESCRIPTION DRUG LABEL 1 0069-3051 POWDER, FOR SUSPENSION 1 g ORAL NDA 31 sections
ZITHROMAX HUMAN PRESCRIPTION DRUG LABEL 1 0069-3051 POWDER, FOR SUSPENSION 1 g ORAL NDA 31 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3060 TABLET, FILM COATED 250 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3060 TABLET, FILM COATED 250 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3060 TABLET, FILM COATED 250 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3070 TABLET, FILM COATED 500 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3070 TABLET, FILM COATED 500 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3070 TABLET, FILM COATED 500 mg ORAL NDA 30 sections
ZITHROMAX HUMAN PRESCRIPTION DRUG LABEL 1 0069-3080 TABLET, FILM COATED 600 mg ORAL NDA 31 sections
ZITHROMAX HUMAN PRESCRIPTION DRUG LABEL 1 0069-3080 TABLET, FILM COATED 600 mg ORAL NDA 31 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3110 POWDER, FOR SUSPENSION 100 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3110 POWDER, FOR SUSPENSION 100 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3110 POWDER, FOR SUSPENSION 100 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3120 POWDER, FOR SUSPENSION 200 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3120 POWDER, FOR SUSPENSION 200 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3120 POWDER, FOR SUSPENSION 200 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3130 POWDER, FOR SUSPENSION 200 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3130 POWDER, FOR SUSPENSION 200 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3130 POWDER, FOR SUSPENSION 200 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3140 POWDER, FOR SUSPENSION 200 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3140 POWDER, FOR SUSPENSION 200 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3140 POWDER, FOR SUSPENSION 200 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3150 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS NDA 29 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3150 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS NDA 29 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-4061 TABLET, FILM COATED 250 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-4061 TABLET, FILM COATED 250 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-4061 TABLET, FILM COATED 250 mg ORAL NDA 30 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-9500 TABLET, FILM COATED 250 mg ORAL UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE 32 sections