azithromycin ๐Ÿถ 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 ยตM/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 1496.83 9.93 1972 83533 249038 50270581
Infective pulmonary exacerbation of cystic fibrosis 751.76 9.93 333 85172 7576 50512043
Abortion incomplete 532.31 9.93 200 85305 2926 50516693
Off label use 523.25 9.93 1871 83634 472555 50047064
Cystic fibrosis 251.09 9.93 114 85391 2750 50516869
Asthma 240.95 9.93 492 85013 88845 50430774
Abortion spontaneous 236.16 9.93 321 85184 41451 50478168
Contraindicated product administered 197.57 9.93 14 85491 148944 50370675
Joint swelling 192.27 9.93 87 85418 245199 50274420
Electrocardiogram QT prolonged 186.21 9.93 323 85182 51563 50468056
Completed suicide 176.05 9.93 12 85493 131877 50387742
Macular degeneration 169.68 9.93 162 85343 14226 50505393
Wheezing 168.73 9.93 343 85162 61704 50457915
Cholecystitis chronic 162.31 9.93 133 85372 9536 50510083
Haemorrhage 153.17 9.93 302 85203 53139 50466480
Hand deformity 150.48 9.93 4 85501 100195 50419424
Synovitis 149.83 9.93 17 85488 123848 50395771
Systemic lupus erythematosus 139.70 9.93 33 85472 140589 50379030
Injury 138.42 9.93 275 85230 48650 50470969
Exposure during pregnancy 134.53 9.93 480 85025 120535 50399084
Bronchiectasis 133.22 9.93 122 85383 10161 50509458
Cough 132.64 9.93 777 84728 240487 50279132
Product packaging quantity issue 130.77 9.93 54 85451 1026 50518593
Arthropathy 128.41 9.93 53 85452 157853 50361766
No adverse event 128.31 9.93 215 85290 33363 50486256
Arthralgia 118.51 9.93 365 85140 438337 50081282
Therapeutic product effect decreased 118.40 9.93 41 85464 136009 50383610
Infusion related reaction 118.12 9.93 70 85435 169487 50350132
Glossodynia 117.02 9.93 26 85479 115543 50404076
Emotional distress 111.48 9.93 185 85320 28478 50491141
Alopecia 105.19 9.93 157 85348 244890 50274729
Productive cough 103.57 9.93 256 85249 52438 50467181
Rheumatoid arthritis 99.96 9.93 117 85388 202433 50317186
Sputum discoloured 99.54 9.93 118 85387 13277 50506342
Wound 97.14 9.93 29 85476 105765 50413854
Product use in unapproved indication 93.70 9.93 416 85089 115403 50404216
Pneumonia 87.41 9.93 1000 84505 377401 50142218
Premature delivery 87.06 9.93 149 85356 23514 50496105
Sleep disorder due to a general medical condition 86.92 9.93 83 85422 7288 50512331
Haemoptysis 81.21 9.93 151 85354 25422 50494197
Pulmonary function test decreased 79.74 9.93 57 85448 3331 50516288
Long QT syndrome 79.38 9.93 54 85451 2913 50516706
Swelling 79.27 9.93 136 85369 200736 50318883
Pericarditis 77.07 9.93 19 85486 78670 50440949
Pulmonary embolism 76.80 9.93 358 85147 101346 50418273
Biliary dyskinesia 74.45 9.93 49 85456 2501 50517118
Anosmia 74.35 9.93 58 85447 3873 50515746
Treatment failure 73.97 9.93 74 85431 137563 50382056
Drug intolerance 72.93 9.93 164 85341 218940 50300679
Hepatic enzyme increased 71.41 9.93 76 85429 137304 50382315
Upper respiratory tract infection 71.12 9.93 259 85246 65639 50453980
Infective exacerbation of bronchiectasis 66.09 9.93 24 85481 317 50519302
Drug interaction 64.59 9.93 566 84939 199055 50320564
Helicobacter infection 62.18 9.93 6 85499 49696 50469923
Asthma-chronic obstructive pulmonary disease overlap syndrome 61.78 9.93 25 85480 450 50519169
Bronchitis 61.37 9.93 342 85163 103817 50415802
Respiratory failure 59.56 9.93 308 85197 90873 50428746
Fatigue 59.47 9.93 841 84664 706760 49812859
Fall 59.35 9.93 328 85177 334604 50185015
Cystic fibrosis respiratory infection suppression 59.13 9.93 21 85484 259 50519360
Drug ineffective for unapproved indication 58.22 9.93 118 85387 21163 50498456
Deafness 57.98 9.93 99 85406 15592 50504027
Nasal polyps 57.89 9.93 42 85463 2512 50517107
Peripheral swelling 57.83 9.93 168 85337 205768 50313851
Pathogen resistance 57.68 9.93 59 85446 5630 50513989
Intentional overdose 57.61 9.93 17 85488 62487 50457132
Torsade de pointes 56.58 9.93 84 85421 11751 50507868
Discomfort 56.26 9.93 60 85445 108320 50411299
Hypoxia 56.06 9.93 202 85303 50921 50468698
Product quality issue 54.48 9.93 144 85361 30714 50488905
Toxicity to various agents 54.26 9.93 181 85324 212318 50307301
Drug abuse 53.85 9.93 17 85488 59829 50459790
Abdominal discomfort 52.74 9.93 207 85298 231434 50288185
Death 52.65 9.93 328 85177 325051 50194568
Gallbladder disorder 52.08 9.93 98 85407 16644 50502975
Factor V inhibition 52.08 9.93 17 85488 159 50519460
COVID-19 51.70 9.93 185 85320 46477 50473142
Obstructive airways disorder 51.68 9.93 94 85411 15558 50504061
Chronic kidney disease 51.38 9.93 166 85339 39605 50480014
Rhinitis allergic 51.15 9.93 62 85443 7138 50512481
Muscle injury 50.61 9.93 3 85502 37108 50482511
Mobility decreased 50.23 9.93 37 85468 79911 50439708
Chronic obstructive pulmonary disease 49.42 9.93 200 85305 53235 50466384
Product dose omission issue 48.37 9.93 499 85006 183339 50336280
Impaired healing 48.28 9.93 29 85476 69757 50449862
Cholelithiasis 47.70 9.93 157 85348 37816 50481803
Dyspnoea 46.85 9.93 1233 84272 546375 49973244
Rales 46.53 9.93 70 85435 9908 50509711
Folliculitis 45.89 9.93 6 85499 39219 50480400
Total lung capacity increased 45.62 9.93 23 85482 704 50518915
Drug-induced liver injury 43.53 9.93 125 85380 27970 50491649
Eosinophilic pneumonia 42.45 9.93 31 85474 1873 50517746
Malignant neoplasm progression 42.18 9.93 32 85473 68092 50451527
Forced expiratory volume decreased 41.73 9.93 44 85461 4350 50515269
Drug reaction with eosinophilia and systemic symptoms 40.73 9.93 123 85382 28301 50491318
Tinnitus 39.62 9.93 121 85384 28011 50491608
Lung opacity 39.25 9.93 30 85475 1943 50517676
Stevens-Johnson syndrome 38.89 9.93 102 85403 21650 50497969
Dysbiosis 38.85 9.93 20 85485 640 50518979
Sleep disorder due to general medical condition, insomnia type 38.80 9.93 4 85501 31443 50488176
Respiratory tract infection 38.11 9.93 130 85375 31887 50487732
Lip oedema 37.73 9.93 36 85469 3157 50516462
Auscultation 37.70 9.93 7 85498 0 50519619
Full blood count abnormal 37.15 9.93 105 85400 23283 50496336
Pseudomonas infection 36.84 9.93 61 85444 9369 50510250
Alveolitis 36.65 9.93 32 85473 2502 50517117
Musculoskeletal stiffness 36.63 9.93 104 85401 128377 50391242
Chest discomfort 35.36 9.93 273 85232 92449 50427170
Sputum increased 34.13 9.93 27 85478 1840 50517779
Acute generalised exanthematous pustulosis 33.82 9.93 57 85448 8881 50510738
Eosinophil count increased 33.00 9.93 56 85449 8774 50510845
Kounis syndrome 32.90 9.93 22 85483 1153 50518466
Myasthenia gravis crisis 32.61 9.93 15 85490 373 50519246
Knee arthroplasty 32.57 9.93 10 85495 35836 50483783
Drug resistance 31.89 9.93 87 85418 18902 50500717
Ventricular fibrillation 31.84 9.93 61 85444 10498 50509121
Prolonged expiration 31.69 9.93 18 85487 703 50518916
Deep vein thrombosis 31.46 9.93 222 85283 73082 50446537
Low birth weight baby 31.41 9.93 44 85461 5837 50513782
Heart sounds 31.17 9.93 17 85488 613 50519006
Suicide attempt 31.14 9.93 25 85480 51707 50467912
Pregnancy 30.84 9.93 115 85390 29462 50490157
Bronchial wall thickening 30.41 9.93 19 85486 886 50518733
Cystic fibrosis pancreatic 30.36 9.93 9 85496 59 50519560
Distal intestinal obstruction syndrome 30.33 9.93 14 85491 351 50519268
Toxic epidermal necrolysis 30.23 9.93 91 85414 20901 50498718
Device expulsion 30.15 9.93 6 85499 28816 50490803
Congenital absence of cranial vault 30.03 9.93 7 85498 14 50519605
Respiration abnormal 30.02 9.93 40 85465 5062 50514557
Eosinophilia 29.88 9.93 84 85421 18568 50501051
Middle lobe syndrome 29.69 9.93 8 85497 35 50519584
Bronchopulmonary aspergillosis 29.51 9.93 49 85456 7543 50512076
Somnolence 29.49 9.93 148 85357 154837 50364782
Confusional state 29.21 9.93 189 85316 185739 50333880
Febrile neutropenia 28.62 9.93 78 85427 97589 50422030
Overdose 28.22 9.93 81 85424 99646 50419973
Acute respiratory distress syndrome 28.09 9.93 89 85416 21010 50498609
Bronchopulmonary aspergillosis allergic 27.94 9.93 20 85485 1171 50518448
Product use issue 27.73 9.93 144 85361 149331 50370288
Blister 27.51 9.93 65 85440 85353 50434266
Stomatitis 26.75 9.93 85 85420 101259 50418360
Anxiety 26.70 9.93 435 85070 177171 50342448
Maternal exposure during pregnancy 26.55 9.93 398 85107 159380 50360239
Total lung capacity decreased 26.50 9.93 20 85485 1271 50518348
Gallbladder injury 26.46 9.93 20 85485 1274 50518345
Mechanical urticaria 26.21 9.93 13 85492 384 50519235
Ageusia 25.69 9.93 59 85446 11524 50508095
Pelvic inflammatory disease 25.67 9.93 21 85484 1501 50518118
Anhedonia 25.09 9.93 52 85453 9472 50510147
Gastroenteritis staphylococcal 25.08 9.93 8 85497 69 50519550
Irritable bowel syndrome 25.02 9.93 30 85475 51411 50468208
Rheumatoid factor 24.98 9.93 8 85497 70 50519549
Mixed liver injury 24.98 9.93 30 85475 3421 50516198
Injection site pain 24.73 9.93 100 85405 110924 50408695
COVID-19 pneumonia 24.71 9.93 48 85457 8347 50511272
Abdominal pain 24.65 9.93 547 84958 235681 50283938
Factor V deficiency 24.59 9.93 8 85497 74 50519545
Ototoxicity 24.34 9.93 18 85487 1109 50518510
Pneumothorax 24.27 9.93 65 85440 13969 50505650
Stenotrophomonas infection 23.99 9.93 21 85484 1648 50517971
Gallbladder cholesterolosis 23.67 9.93 15 85490 717 50518902
Epidermolysis 23.16 9.93 10 85495 213 50519406
Lung transplant rejection 22.99 9.93 15 85490 754 50518865
Coma 22.87 9.93 38 85467 56841 50462778
Granulomatosis with polyangiitis 22.62 9.93 21 85484 1779 50517840
Injection site erythema 22.59 9.93 59 85446 74877 50444742
Drug effective for unapproved indication 22.51 9.93 22 85483 1987 50517632
Pneumonia pseudomonal 22.38 9.93 22 85483 2001 50517618
Drug ineffective 22.35 9.93 1145 84360 818188 49701431
Breath sounds abnormal 22.26 9.93 44 85461 7748 50511871
Sinusitis 22.12 9.93 408 85097 170150 50349469
Endometritis 22.02 9.93 16 85489 959 50518660
Cystic fibrosis lung 21.94 9.93 8 85497 107 50519512
Uterine perforation 21.78 9.93 39 85466 6376 50513243
Delusional disorder, persecutory type 21.70 9.93 9 85496 173 50519446
Amniotic cavity infection 21.65 9.93 17 85488 1146 50518473
Urticaria 21.62 9.93 323 85182 129238 50390381
Hospitalisation 21.59 9.93 192 85313 67745 50451874
Symmetrical drug-related intertriginous and flexural exanthema 21.40 9.93 11 85494 351 50519268
Hypotension 21.38 9.93 275 85230 235194 50284425
Agranulocytosis 21.27 9.93 82 85423 21339 50498280
Gastrointestinal haemorrhage 21.14 9.93 59 85446 73262 50446357
Platelet count decreased 21.02 9.93 93 85412 100633 50418986
Pulmonary infarction 20.99 9.93 23 85482 2375 50517244
Flank pain 20.94 9.93 59 85446 13056 50506563
Cystic fibrosis related diabetes 20.56 9.93 6 85499 37 50519582
Hip arthroplasty 20.55 9.93 13 85492 30416 50489203
Staphylococcus test positive 20.49 9.93 27 85478 3379 50516240
Transaminases increased 20.28 9.93 97 85408 27727 50491892
Neutrophil count decreased 20.18 9.93 29 85476 45997 50473622
Pneumothorax spontaneous 20.12 9.93 13 85492 643 50518976
C-reactive protein abnormal 20.02 9.93 11 85494 27798 50491821
Mycobacterium avium complex infection 19.98 9.93 23 85482 2507 50517112
Bronchomalacia 19.98 9.93 9 85496 213 50519406
Bronchial secretion retention 19.69 9.93 18 85487 1495 50518124
Pneumomediastinum 19.64 9.93 16 85489 1137 50518482
Neutropenia 19.55 9.93 158 85347 147807 50371812
Injection site bruising 19.47 9.93 20 85485 36748 50482871
Orthostatic hypotension 19.36 9.93 13 85492 29468 50490151
Sarcoidosis 18.99 9.93 32 85473 4985 50514634
Pancreatic failure 18.91 9.93 14 85491 864 50518755
Actinic keratosis 18.87 9.93 21 85484 2206 50517413
Premature baby 18.87 9.93 71 85434 18266 50501353
Meningism 18.53 9.93 10 85495 353 50519266
Oropharyngeal pain 18.48 9.93 207 85298 77594 50442025
Obliterative bronchiolitis 18.39 9.93 19 85486 1834 50517785
Blood pressure fluctuation 18.39 9.93 20 85485 35803 50483816
Biliary colic 18.33 9.93 25 85480 3234 50516385
Weight increased 18.24 9.93 236 85269 201655 50317964
Sedation 18.16 9.93 15 85490 30595 50489024
Post polio syndrome 17.89 9.93 4 85501 6 50519613
Hepatocellular injury 17.87 9.93 89 85416 25858 50493761
Breast cancer 17.85 9.93 28 85477 42862 50476757
Hypersensitivity 17.83 9.93 256 85249 214905 50304714
Oral candidiasis 17.83 9.93 66 85439 16849 50502770
Influenza 17.67 9.93 230 85275 89308 50430311
Rhinorrhoea 17.55 9.93 148 85357 51435 50468184
Immunodeficiency common variable 17.45 9.93 7 85498 123 50519496
Viral infection 17.33 9.93 98 85407 29888 50489731
Increased bronchial secretion 17.31 9.93 17 85488 1545 50518074
Gait disturbance 17.25 9.93 166 85339 149839 50369780
Respiratory tract congestion 17.20 9.93 58 85447 14141 50505478
Mucocutaneous candidiasis 17.16 9.93 4 85501 8 50519611
Joint range of motion decreased 17.12 9.93 5 85500 18507 50501112
Mycobacterial infection 17.00 9.93 17 85488 1579 50518040
Hypokalaemia 16.74 9.93 84 85421 87908 50431711
Cholestasis 16.70 9.93 86 85419 25315 50494304
Rheumatic fever 16.65 9.93 4 85501 16863 50502756
Hallucinations, mixed 16.64 9.93 27 85478 4076 50515543
Peak expiratory flow rate abnormal 16.61 9.93 6 85499 78 50519541
Laryngeal mass 16.59 9.93 5 85500 35 50519584
Pain in extremity 16.38 9.93 344 85161 272521 50247098
Iris transillumination defect 16.27 9.93 6 85499 83 50519536
Pigment nephropathy 16.23 9.93 5 85500 38 50519581
Neisseria infection 16.23 9.93 5 85500 38 50519581
Bronchogram abnormal 16.16 9.93 3 85502 0 50519619
Portal hypertensive enteropathy 16.16 9.93 3 85502 0 50519619
Urinary tract infection 16.04 9.93 274 85231 223746 50295873
Hemianopia heteronymous 16.01 9.93 5 85500 40 50519579
Sinus congestion 15.99 9.93 56 85449 13915 50505704
Mucosal inflammation 15.97 9.93 27 85478 40115 50479504
Crystal arthropathy 15.92 9.93 8 85497 243 50519376
Palmar-plantar erythrodysaesthesia syndrome 15.91 9.93 7 85498 20091 50499528
Injection site swelling 15.80 9.93 29 85476 41744 50477875
Erythema multiforme 15.73 9.93 42 85463 9008 50510611
Pain 15.72 9.93 809 84696 578094 49941525
White blood cell count decreased 15.71 9.93 124 85381 116598 50403021
Appetite disorder 15.66 9.93 33 85472 6081 50513538
Immune reconstitution inflammatory syndrome 15.58 9.93 31 85474 5485 50514134
Oesophagogastroduodenoscopy 15.47 9.93 6 85499 96 50519523
Tachypnoea 15.46 9.93 57 85448 14520 50505099
Hyponatraemia 15.45 9.93 97 85408 96042 50423577
Aspergillus infection 15.41 9.93 35 85470 6786 50512833
Ventricular tachycardia 15.25 9.93 60 85445 15761 50503858
Hypoxic-ischaemic encephalopathy 15.20 9.93 25 85480 3817 50515802
Leukaemoid reaction 15.15 9.93 7 85498 176 50519443
Osteoarthritis 15.14 9.93 62 85443 68544 50451075
HIV infection 14.99 9.93 8 85497 276 50519343
Mycoplasma infection 14.94 9.93 9 85496 393 50519226
Hypersensitivity pneumonitis 14.90 9.93 19 85486 2303 50517316
Respiratory tract inflammation 14.86 9.93 10 85495 530 50519089
Neural tube defect 14.83 9.93 7 85498 185 50519434
Pharyngeal enanthema 14.76 9.93 5 85500 53 50519566
Ear discomfort 14.57 9.93 34 85471 6710 50512909
Humidity intolerance 14.55 9.93 8 85497 293 50519326
Hepatitis cholestatic 14.50 9.93 32 85473 6085 50513534
Multiple allergies 14.43 9.93 39 85466 8424 50511195
Gastrointestinal disorder 14.32 9.93 97 85408 94359 50425260
Rebound acid hypersecretion 14.31 9.93 8 85497 303 50519316
Hypertension 14.27 9.93 261 85244 210942 50308677
Disease progression 14.26 9.93 99 85406 95767 50423852
Foetal death 14.26 9.93 38 85467 8142 50511477
Acute respiratory failure 14.04 9.93 90 85415 28692 50490927
Hypofibrinogenaemia 14.03 9.93 13 85492 1099 50518520
Catastrophic reaction 13.94 9.93 4 85501 23 50519596
Myasthenia gravis 13.90 9.93 23 85482 3529 50516090
Forced vital capacity decreased 13.85 9.93 12 85493 929 50518690
Disease risk factor 13.84 9.93 5 85500 65 50519554
Lymph node abscess 13.80 9.93 4 85501 24 50519595
Monoclonal gammopathy 13.71 9.93 10 85495 603 50519016
Therapeutic response decreased 13.62 9.93 38 85467 47193 50472426
Meningoencephalitis bacterial 13.57 9.93 5 85500 69 50519550
Sputum retention 13.49 9.93 9 85496 470 50519149
Urethral stenosis 13.46 9.93 7 85498 229 50519390
Eye irritation 13.41 9.93 61 85444 17079 50502540
Joint stiffness 13.38 9.93 19 85486 30289 50489330
Injection site haemorrhage 13.24 9.93 10 85495 21336 50498283
Asthmatic crisis 13.19 9.93 15 85490 1613 50518006
Anal inflammation 13.16 9.93 6 85499 146 50519473
Sleep disorder 13.13 9.93 51 85454 57232 50462387
Pyrexia 13.12 9.93 776 84729 379427 50140192
Cognitive disorder 13.10 9.93 35 85470 44088 50475531
Dermatosis 13.08 9.93 7 85498 243 50519376
General physical health deterioration 13.04 9.93 166 85339 142268 50377351
Contusion 12.95 9.93 124 85381 112059 50407560
Hypoacusis 12.95 9.93 69 85436 20578 50499041
Gastrooesophageal reflux disease 12.92 9.93 191 85314 76237 50443382
Kawasaki's disease 12.87 9.93 3 85502 6 50519613
Pneumonia bacterial 12.79 9.93 34 85471 7275 50512344
Blood cholesterol increased 12.75 9.93 49 85456 55166 50464453
Gallbladder hypofunction 12.74 9.93 9 85496 516 50519103
Psoriatic arthropathy 12.72 9.93 39 85466 46993 50472626
Acute kidney injury 12.66 9.93 488 85017 227570 50292049
Rhinovirus infection 12.66 9.93 22 85483 3512 50516107
Veillonella infection 12.59 9.93 4 85501 34 50519585
Stomatococcal infection 12.56 9.93 5 85500 86 50519533
Tympanic membrane hyperaemia 12.56 9.93 3 85502 7 50519612
Injection site reaction 12.48 9.93 43 85462 49989 50469630
Foetal exposure during pregnancy 12.40 9.93 84 85421 27275 50492344
Injection site warmth 12.36 9.93 4 85501 13862 50505757
Deafness neurosensory 12.36 9.93 25 85480 4476 50515143
Eosinophilic pneumonia chronic 12.36 9.93 6 85499 169 50519450
Nosocomial infection 12.30 9.93 14 85491 1508 50518111
Central nervous system fungal infection 12.20 9.93 5 85500 93 50519526
Pneumonia aspiration 12.20 9.93 21 85484 30983 50488636
Chest pain 12.18 9.93 388 85117 176494 50343125
Cardiac murmur 12.15 9.93 43 85462 10741 50508878
Adverse drug reaction 12.12 9.93 50 85455 55172 50464447
Product colour issue 12.09 9.93 9 85496 560 50519059
Ruptured ectopic pregnancy 12.06 9.93 8 85497 414 50519205
Type 2 diabetes mellitus 12.01 9.93 25 85480 34350 50485269
Local reaction 11.99 9.93 9 85496 567 50519052
Interleukin level increased 11.95 9.93 7 85498 290 50519329
Lung disorder 11.94 9.93 122 85383 44677 50474942
Osteonecrosis of jaw 11.93 9.93 23 85482 32503 50487116
Pneumopericardium 11.93 9.93 4 85501 41 50519578
Increased upper airway secretion 11.83 9.93 20 85485 3124 50516495
Sinus disorder 11.79 9.93 62 85443 18396 50501223
BK virus infection 11.74 9.93 19 85486 2862 50516757
Dehydration 11.72 9.93 184 85321 152265 50367354
Infusion site streaking 11.69 9.93 8 85497 436 50519183
Dysentery 11.68 9.93 10 85495 761 50518858
Eosinophilic pneumonia acute 11.67 9.93 7 85498 303 50519316
Sputum purulent 11.65 9.93 11 85494 952 50518667
Vascular parkinsonism 11.60 9.93 5 85500 106 50519513
Purpura 11.58 9.93 40 85465 9871 50509748
Diabetic ketoacidosis 11.57 9.93 8 85497 17864 50501755
Lung diffusion test decreased 11.55 9.93 9 85496 600 50519019
Genital ulceration 11.54 9.93 8 85497 445 50519174
Altered state of consciousness 11.51 9.93 12 85493 21898 50497721
Cardiac arrest 11.50 9.93 202 85303 83449 50436170
Sopor 11.48 9.93 10 85495 19869 50499750
Cranial nerve paralysis 11.48 9.93 5 85500 109 50519510
Biopsy colon abnormal 11.48 9.93 5 85500 109 50519510
Depressed level of consciousness 11.43 9.93 47 85458 51906 50467713
Acute disseminated encephalomyelitis 11.43 9.93 6 85499 200 50519419
COVID-19 treatment 11.39 9.93 5 85500 111 50519508
Hepato-lenticular degeneration 11.35 9.93 3 85502 12 50519607
Anal skin tags 11.35 9.93 7 85498 319 50519300
Brain hypoxia 11.34 9.93 8 85497 458 50519161
Mucosal dryness 11.33 9.93 17 85488 2400 50517219
Abscess bacterial 11.32 9.93 6 85499 204 50519415
Vulvovaginal candidiasis 11.31 9.93 18 85487 2674 50516945
Seasonal allergy 11.31 9.93 52 85453 14624 50504995
Acute sinusitis 11.27 9.93 21 85484 3539 50516080
Gait inability 11.27 9.93 29 85476 36998 50482621
Arthritis 11.27 9.93 93 85412 86628 50432991
Bacterial disease carrier 11.25 9.93 10 85495 801 50518818
Immune reconstitution inflammatory syndrome associated tuberculosis 11.23 9.93 7 85498 325 50519294
SJS-TEN overlap 11.04 9.93 6 85499 215 50519404
Hypoventilation 11.03 9.93 22 85483 3899 50515720
Procedural anxiety 10.91 9.93 9 85496 651 50518968
Constipation 10.88 9.93 235 85270 185473 50334146
Dysarthria 10.85 9.93 30 85475 37373 50482246
HIV-associated neurocognitive disorder 10.81 9.93 5 85500 126 50519493
Otitis media fungal 10.81 9.93 3 85502 15 50519604
Ureteric perforation 10.81 9.93 3 85502 15 50519604
Immunosuppressant drug level increased 10.80 9.93 19 85486 3063 50516556
Hypercapnia 10.74 9.93 24 85481 4603 50515016
Muscle spasticity 10.73 9.93 8 85497 17176 50502443
Respiratory distress 10.64 9.93 88 85417 30401 50489218
Metastases to liver 10.57 9.93 11 85494 20093 50499526
Catarrh 10.52 9.93 7 85498 364 50519255
Metastases to bone 10.45 9.93 9 85496 17986 50501633
Balance disorder 10.45 9.93 73 85432 70517 50449102
Angina bullosa haemorrhagica 10.36 9.93 5 85500 139 50519480
Spinal stenosis 10.29 9.93 5 85500 13545 50506074
Depressive symptom 10.29 9.93 19 85486 3181 50516438
Amaurosis 10.28 9.93 8 85497 532 50519087
Respiratory syncytial virus infection 10.24 9.93 25 85480 5077 50514542
Herpes simplex viraemia 10.10 9.93 5 85500 147 50519472
Photodermatosis 10.07 9.93 7 85498 391 50519228
Epilepsy 10.04 9.93 13 85492 21554 50498065
Respiratory tract infection fungal 10.01 9.93 7 85498 395 50519224
Multiple sclerosis relapse 10.00 9.93 38 85467 42926 50476693
ECG signs of myocardial ischaemia 9.99 9.93 4 85501 70 50519549

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 1977.52 10.30 2747 58841 298053 29214886
Infective pulmonary exacerbation of cystic fibrosis 602.66 10.30 283 61305 5953 29506986
Electrocardiogram QT prolonged 390.50 10.30 427 61161 35710 29477229
Drug hypersensitivity 198.26 10.30 439 61149 67967 29444972
Product use in unapproved indication 182.93 10.30 493 61095 86382 29426557
Asthma 181.22 10.30 283 61305 33566 29479373
Long QT syndrome 165.80 10.30 85 61503 2173 29510766
Drug ineffective for unapproved indication 139.72 10.30 160 61428 14054 29498885
Drug interaction 131.82 10.30 780 60808 196605 29316334
No adverse event 130.11 10.30 171 61417 17307 29495632
Hepatitis 127.19 10.30 185 61403 20598 29492341
Immune reconstitution inflammatory syndrome 126.38 10.30 115 61473 7687 29505252
Drug effective for unapproved indication 122.20 10.30 60 61528 1395 29511544
Hypertransaminasaemia 121.58 10.30 82 61506 3524 29509415
Drug abuse 120.41 10.30 13 61575 79870 29433069
Cystic fibrosis 117.82 10.30 59 61529 1433 29511506
Bronchiectasis 114.45 10.30 101 61487 6484 29506455
Completed suicide 112.72 10.30 25 61563 90221 29422718
Condition aggravated 106.61 10.30 592 60996 145703 29367236
Fall 96.68 10.30 137 61451 177041 29335898
Obstructive airways disorder 93.39 10.30 115 61473 10901 29502038
Productive cough 93.13 10.30 203 61385 31056 29481883
Haemoptysis 90.57 10.30 198 61390 30352 29482587
Vanishing bile duct syndrome 90.35 10.30 37 61551 551 29512388
Cough 88.42 10.30 507 61081 126220 29386719
Death 84.08 10.30 397 61191 341687 29171252
Wheezing 83.70 10.30 202 61386 33038 29479901
Product packaging quantity issue 80.98 10.30 37 61551 728 29512211
Stevens-Johnson syndrome 78.77 10.30 131 61457 16366 29496573
Breath sounds abnormal 76.04 10.30 74 61514 5383 29507556
Pulmonary function test decreased 74.64 10.30 65 61523 4098 29508841
Malignant neoplasm progression 70.13 10.30 33 61555 73826 29439113
Eosinophil count abnormal 69.46 10.30 25 61563 256 29512683
Solar lentigo 66.67 10.30 27 61561 390 29512549
Dysplastic naevus 65.93 10.30 27 61561 402 29512537
Photodermatosis 64.17 10.30 27 61561 432 29512507
Toxicity to various agents 63.62 10.30 170 61418 173491 29339448
Torsade de pointes 60.47 10.30 72 61516 6589 29506350
Forced expiratory volume decreased 56.74 10.30 47 61541 2766 29510173
Ototoxicity 56.16 10.30 37 61551 1528 29511411
Toxic epidermal necrolysis 55.32 10.30 119 61469 18034 29494905
Acute respiratory distress syndrome 53.10 10.30 135 61453 22800 29490139
Congenital hiatus hernia 51.95 10.30 23 61565 419 29512520
Febrile neutropenia 50.70 10.30 98 61490 112142 29400797
Mucocutaneous disorder 49.91 10.30 16 61572 111 29512828
Mycobacterium avium complex infection 48.05 10.30 39 61549 2230 29510709
Hepatitis acute 46.19 10.30 62 61526 6400 29506539
Myocardial infarction 45.02 10.30 102 61486 110194 29402745
Pathogen resistance 44.99 10.30 69 61519 8047 29504892
Sputum increased 44.83 10.30 35 61553 1892 29511047
Sinusitis 44.51 10.30 165 61423 34185 29478754
Alanine aminotransferase increased 43.11 10.30 274 61314 70670 29442269
Respiratory disorder 42.51 10.30 103 61485 16880 29496059
Somnolence 42.45 10.30 82 61506 93873 29419066
Full blood count abnormal 41.88 10.30 95 61493 14918 29498021
Transaminases increased 40.16 10.30 121 61467 22541 29490398
Dizziness 39.76 10.30 232 61356 189452 29323487
General physical health deterioration 39.68 10.30 98 61490 102759 29410180
Acute respiratory failure 39.52 10.30 133 61455 26269 29486670
COVID-19 38.60 10.30 163 61425 35851 29477088
Bronchiolitis obliterans syndrome 37.84 10.30 14 61574 156 29512783
Dehydration 37.82 10.30 118 61470 114630 29398309
Cystic fibrosis respiratory infection suppression 37.79 10.30 15 61573 205 29512734
Parathyroid gland enlargement 37.60 10.30 13 61575 117 29512822
Pneumonia 37.48 10.30 901 60687 319271 29193668
Intentional overdose 36.89 10.30 17 61571 38511 29474428
Sputum discoloured 36.66 10.30 56 61532 6507 29506432
Constipation 36.50 10.30 119 61469 114041 29398898
Upper respiratory fungal infection 36.48 10.30 13 61575 129 29512810
COVID-19 pneumonia 35.65 10.30 68 61520 9454 29503485
Respiratory failure 35.42 10.30 333 61255 96798 29416141
Pseudomonas infection 35.22 10.30 73 61515 10779 29502160
Bronchopulmonary aspergillosis 34.31 10.30 78 61510 12266 29500673
Coma 33.93 10.30 20 61568 39430 29473509
Hypertriglyceridaemia 33.87 10.30 58 61530 7417 29505522
Cryptococcal meningoencephalitis 33.77 10.30 12 61576 118 29512821
Fatigue 33.47 10.30 462 61126 316359 29196580
HIV associated nephropathy 33.40 10.30 15 61573 283 29512656
Forced expiratory volume 32.32 10.30 11 61577 94 29512845
Confusional state 32.07 10.30 147 61441 127730 29385209
Obliterative bronchiolitis 32.05 10.30 23 61565 1093 29511846
COVID-19 treatment 31.82 10.30 14 61574 251 29512688
Decreased appetite 31.38 10.30 176 61412 145166 29367773
Lung transplant rejection 30.65 10.30 19 61569 705 29512234
Scleroderma 30.47 10.30 24 61564 1314 29511625
Overdose 30.03 10.30 77 61511 79742 29433197
HIV infection 28.67 10.30 22 61566 1159 29511780
Lung hyperinflation 28.66 10.30 19 61569 793 29512146
Sleep disorder due to a general medical condition 28.55 10.30 34 61554 3112 29509827
Distal intestinal obstruction syndrome 28.44 10.30 13 61575 256 29512683
Product quality issue 28.29 10.30 85 61503 15810 29497129
Bronchopulmonary aspergillosis allergic 28.23 10.30 16 61572 502 29512437
Cytokine storm 28.19 10.30 17 61571 600 29512339
Pain 27.36 10.30 227 61361 171205 29341734
Bronchitis 27.28 10.30 150 61438 36718 29476221
Herpes simplex viraemia 26.96 10.30 9 61579 72 29512867
Lung transplant 26.72 10.30 25 61563 1731 29511208
Mycobacterium chelonae infection 25.85 10.30 16 61572 592 29512347
Suicide attempt 25.71 10.30 20 61568 34090 29478849
Jaw cyst 25.58 10.30 6 61582 9 29512930
Mycobacterial infection 25.54 10.30 25 61563 1831 29511108
Cystic fibrosis related diabetes 25.37 10.30 10 61578 134 29512805
Rheumatoid arthritis 25.33 10.30 18 61570 32134 29480805
Seizure 25.19 10.30 104 61484 93019 29419920
Drug resistance 25.05 10.30 100 61488 21440 29491499
Hepatocellular injury 25.01 10.30 99 61489 21144 29491795
Haemolytic anaemia 24.51 10.30 58 61530 9361 29503578
Liver function test increased 24.49 10.30 67 61521 11818 29501121
Hepatitis cholestatic 24.31 10.30 48 61540 6845 29506094
Dyspnoea 24.05 10.30 868 60720 325864 29187075
Lip erythema 23.77 10.30 7 61581 35 29512904
Pain in extremity 23.67 10.30 134 61454 110299 29402640
Deafness neurosensory 23.62 10.30 28 61560 2550 29510389
Urinary tract infection 23.40 10.30 75 61513 72279 29440660
Cerebrovascular accident 23.32 10.30 82 61506 76829 29436110
Prostate cancer 23.31 10.30 12 61576 25515 29487424
Injection site pain 23.24 10.30 20 61568 32426 29480513
NPM1 gene mutation 23.08 10.30 9 61579 117 29512822
Bacterial pericarditis 22.84 10.30 7 61581 41 29512898
Urethritis mycoplasmal 22.78 10.30 6 61582 18 29512921
Gastrointestinal haemorrhage 22.66 10.30 87 61501 79446 29433493
Pharyngeal erythema 22.62 10.30 14 61574 518 29512421
Bronchial disorder 22.59 10.30 19 61569 1142 29511797
Conjunctival hyperaemia 22.53 10.30 25 61563 2120 29510819
Lung diffusion disorder 22.48 10.30 8 61580 79 29512860
Total lung capacity abnormal 22.48 10.30 9 61579 126 29512813
Actinic keratosis 22.13 10.30 33 61555 3753 29509186
Wrong technique in product usage process 21.75 10.30 20 61568 31408 29481531
Rash maculovesicular 21.65 10.30 6 61582 23 29512916
Nasal mucosal disorder 21.63 10.30 8 61580 89 29512850
Asthenia 21.57 10.30 317 61271 214933 29298006
Gonorrhoea 21.54 10.30 7 61581 51 29512888
Carbon dioxide increased 21.17 10.30 17 61571 957 29511982
Graft versus host disease in lung 20.84 10.30 13 61575 488 29512451
Linear IgA disease 20.61 10.30 20 61568 1449 29511490
Eosinophilia 20.49 10.30 96 61492 22065 29490874
Infective chondritis 20.41 10.30 5 61583 10 29512929
Blood pressure fluctuation 20.28 10.30 8 61580 19886 29493053
Upper-airway cough syndrome 20.23 10.30 28 61560 2975 29509964
Iris adhesions 20.15 10.30 10 61578 238 29512701
Acquired immunodeficiency syndrome 20.12 10.30 12 61576 415 29512524
Liver injury 19.94 10.30 65 61523 12625 29500314
Methaemoglobinaemia 19.66 10.30 26 61562 2645 29510294
Blood pressure increased 19.60 10.30 83 61505 73720 29439219
Enterovirus infection 19.55 10.30 14 61574 663 29512276
Hepatic necrosis 19.47 10.30 30 61558 3512 29509427
Bronchial hyperreactivity 19.46 10.30 19 61569 1387 29511552
Neutropenia 19.40 10.30 178 61410 131533 29381406
Cardiac failure 19.35 10.30 92 61496 79195 29433744
Blood immunoglobulin E increased 19.26 10.30 22 61566 1925 29511014
Cryptococcosis 19.22 10.30 22 61566 1930 29511009
Cerebral infarction 19.19 10.30 14 61574 24661 29488278
Rubber sensitivity 19.18 10.30 8 61580 125 29512814
Pneumonia mycoplasmal 19.12 10.30 13 61575 566 29512373
Hypoxia 19.06 10.30 166 61422 47213 29465726
Respiratory syncytial virus infection 18.74 10.30 30 61558 3629 29509310
Drug-induced liver injury 18.71 10.30 92 61496 21563 29491376
Liver function test 18.67 10.30 6 61582 42 29512897
Gait disturbance 18.56 10.30 84 61504 73265 29439674
Aspartate aminotransferase increased 18.48 10.30 198 61390 59527 29453412
Mediastinal shift 18.47 10.30 4 61584 3 29512936
Asthma-chronic obstructive pulmonary disease overlap syndrome 18.38 10.30 14 61574 729 29512210
Disseminated cryptococcosis 18.36 10.30 17 61571 1161 29511778
Tooth discolouration 18.36 10.30 10 61578 290 29512649
Alcohol intolerance 18.35 10.30 11 61577 384 29512555
Disease progression 18.31 10.30 98 61490 81818 29431121
Viral infection 18.23 10.30 70 61518 14740 29498199
Secretion discharge 18.20 10.30 32 61556 4178 29508761
Drug reaction with eosinophilia and systemic symptoms 18.17 10.30 110 61478 27882 29485057
Deafness 18.11 10.30 54 61534 10001 29502938
Acoustic neuroma 18.11 10.30 8 61580 145 29512794
Pulmonary function test abnormal 18.07 10.30 22 61566 2060 29510879
Vestibular disorder 17.98 10.30 16 61572 1038 29511901
Oedema peripheral 17.95 10.30 134 61454 103423 29409516
Andersen-Tawil syndrome 17.94 10.30 4 61584 4 29512935
Nervous system neoplasm 17.91 10.30 8 61580 149 29512790
Antinuclear antibody negative 17.88 10.30 5 61583 20 29512919
Chimerism 17.84 10.30 9 61579 222 29512717
Tinnitus 17.76 10.30 72 61516 15542 29497397
Contraindicated product administered 17.57 10.30 8 61580 18258 29494681
Chronic obstructive pulmonary disease 17.27 10.30 145 61443 40810 29472129
Restrictive allograft syndrome 17.14 10.30 5 61583 24 29512915
Anaemia 17.11 10.30 305 61283 200646 29312293
Decreased activity 16.93 10.30 29 61559 3709 29509230
Cardiac failure congestive 16.90 10.30 92 61496 76489 29436450
Therapeutic product effect decreased 16.79 10.30 22 61566 29429 29483510
Hepatomegaly 16.74 10.30 50 61538 9267 29503672
Pancreatic failure 16.72 10.30 13 61575 698 29512241
Hypofibrinogenaemia 16.64 10.30 18 61570 1483 29511456
End stage renal disease 16.59 10.30 44 61544 7620 29505319
Ascites 16.49 10.30 32 61556 36587 29476352
Lung infiltration 16.45 10.30 58 61530 11721 29501218
Stenotrophomonas infection 16.31 10.30 19 61569 1698 29511241
Osteonecrosis of jaw 16.25 10.30 7 61581 16503 29496436
Atypical mycobacterial lower respiratory tract infection 16.22 10.30 5 61583 30 29512909
Cognitive disorder 16.21 10.30 15 61573 23484 29489455
Mastocytosis 16.08 10.30 5 61583 31 29512908
Urinary retention 16.05 10.30 26 61562 31872 29481067
Glucose-6-phosphate dehydrogenase deficiency 15.94 10.30 7 61581 125 29512814
Mucormycosis 15.92 10.30 34 61554 5124 29507815
Interstitial lung disease 15.89 10.30 64 61524 57654 29455285
Pseudomembranous colitis 15.71 10.30 23 61565 2574 29510365
Hypercapnia 15.70 10.30 28 61560 3698 29509241
Lymph node palpable 15.68 10.30 5 61583 34 29512905
Pneumothorax 15.66 10.30 70 61518 15772 29497167
Haemoglobin E disease 15.53 10.30 3 61585 0 29512939
Senile pruritus 15.53 10.30 3 61585 0 29512939
Forced vital capacity decreased 15.36 10.30 12 61576 649 29512290
Premature baby 15.35 10.30 74 61514 17206 29495733
CD4 lymphocytes increased 15.34 10.30 8 61580 212 29512727
Enterobacter infection 15.28 10.30 20 61568 2014 29510925
Deafness unilateral 15.23 10.30 19 61569 1824 29511115
Immunodeficiency common variable 15.21 10.30 7 61581 140 29512799
ADAMTS13 activity decreased 15.18 10.30 6 61582 81 29512858
Myopia 15.05 10.30 14 61574 962 29511977
Hospitalisation 14.95 10.30 154 61434 45834 29467105
Palmar-plantar erythrodysaesthesia syndrome 14.94 10.30 6 61582 14753 29498186
Rash maculo-papular 14.85 10.30 94 61494 24195 29488744
Oral mucosa erosion 14.81 10.30 13 61575 828 29512111
Bronchomalacia 14.79 10.30 6 61582 87 29512852
Platelet count decreased 14.74 10.30 143 61445 104529 29408410
Tachyarrhythmia 14.74 10.30 24 61564 2945 29509994
Fungal disease carrier 14.62 10.30 8 61580 234 29512705
Borderline personality disorder 14.59 10.30 9 61579 331 29512608
Cytomegalovirus chorioretinitis 14.51 10.30 25 61563 3213 29509726
SJS-TEN overlap 14.32 10.30 8 61580 244 29512695
Tongue discolouration 14.31 10.30 14 61574 1025 29511914
Palatal oedema 14.30 10.30 12 61576 719 29512220
Hypocapnia 14.28 10.30 7 61581 162 29512777
Rotavirus infection 14.28 10.30 9 61579 344 29512595
Pneumonia pseudomonal 14.23 10.30 25 61563 3262 29509677
Severe acute respiratory syndrome 14.18 10.30 5 61583 48 29512891
Genital ulceration 14.17 10.30 7 61581 165 29512774
Contusion 14.15 10.30 27 61561 31068 29481871
Anosmia 14.07 10.30 19 61569 1972 29510967
Pneumonia escherichia 14.03 10.30 9 61579 355 29512584
Cerebral toxoplasmosis 14.01 10.30 16 61572 1400 29511539
Influenza 13.97 10.30 141 61447 41740 29471199
Respiratory tract infection bacterial 13.97 10.30 11 61577 602 29512337
Dysarthria 13.92 10.30 27 61561 30884 29482055
Viral pharyngitis 13.88 10.30 6 61582 103 29512836
Cholestasis 13.85 10.30 90 61498 23372 29489567
Aspergillus infection 13.84 10.30 51 61537 10530 29502409
Neurological examination abnormal 13.83 10.30 8 61580 261 29512678
Upper respiratory tract infection 13.83 10.30 101 61487 27248 29485691
Myasthenia gravis crisis 13.83 10.30 10 61578 481 29512458
Arthralgia 13.82 10.30 206 61382 139411 29373528
Syncope 13.76 10.30 106 61482 81265 29431674
Anticoagulation drug level above therapeutic 13.75 10.30 18 61570 1813 29511126
Drug ineffective 13.75 10.30 904 60684 362266 29150673
Cystic fibrosis lung 13.74 10.30 5 61583 53 29512886
Rhinalgia 13.67 10.30 9 61579 371 29512568
Depressed level of consciousness 13.61 10.30 36 61552 36906 29476033
Hypotension 13.53 10.30 305 61283 194049 29318890
Atrial conduction time prolongation 13.46 10.30 3 61585 3 29512936
Papillary muscle rupture 13.46 10.30 3 61585 3 29512936
Metastases to liver 13.41 10.30 4 61584 11852 29501087
Pneumonia aspiration 13.38 10.30 36 61552 36701 29476238
Haemorrhoids thrombosed 13.34 10.30 7 61581 188 29512751
Chronic sinusitis 13.13 10.30 17 61571 1694 29511245
Red blood cell sedimentation rate decreased 13.11 10.30 5 61583 61 29512878
Hyperaemia 13.07 10.30 13 61575 971 29511968
Hypoglycaemia 13.06 10.30 54 61534 48292 29464647
Rheumatic fever 12.97 10.30 4 61584 24 29512915
Hyponatraemia 12.94 10.30 85 61503 67548 29445391
Respiratory depression 12.89 10.30 6 61582 13517 29499422
Hyperkalaemia 12.87 10.30 75 61513 61317 29451622
Tuberculosis gastrointestinal 12.85 10.30 7 61581 203 29512736
Pleural fistula 12.83 10.30 4 61584 25 29512914
Eosinophilic pleural effusion 12.82 10.30 7 61581 204 29512735
Pneumomediastinum 12.78 10.30 17 61571 1739 29511200
Sputum retention 12.78 10.30 9 61579 415 29512524
Malignant melanoma in situ 12.68 10.30 14 61574 1180 29511759
Back pain 12.67 10.30 144 61444 102140 29410799
Seborrhoea 12.63 10.30 7 61581 210 29512729
Lip oedema 12.58 10.30 19 61569 2185 29510754
Therapeutic response decreased 12.57 10.30 20 61568 24691 29488248
Lung disorder 12.53 10.30 107 61481 30255 29482684
Gastrooesophageal reflux disease 12.48 10.30 110 61478 31386 29481553
Flushing 12.48 10.30 26 61562 28966 29483973
Superinfection bacterial 12.47 10.30 11 61577 705 29512234
Folliculitis 12.38 10.30 26 61562 3874 29509065
Eosinophilic pustular folliculitis 12.36 10.30 5 61583 72 29512867
Kidney infection 12.36 10.30 29 61559 4654 29508285
Viral rash 12.30 10.30 5 61583 73 29512866
Prothrombin level decreased 12.28 10.30 13 61575 1045 29511894
Disorientation 12.26 10.30 27 61561 29488 29483451
Achromotrichia congenital 12.25 10.30 3 61585 6 29512933
Cutaneous extramedullary haemopoiesis 12.25 10.30 3 61585 6 29512933
Bladder cancer 12.24 10.30 3 61585 10124 29502815
Chest discomfort 12.22 10.30 148 61440 45835 29467104
Bronchopleural fistula 12.16 10.30 9 61579 449 29512490
Toxic optic neuropathy 12.15 10.30 11 61577 730 29512209
Rhonchi 12.14 10.30 16 61572 1622 29511317
Small intestinal obstruction 12.13 10.30 6 61582 13055 29499884
Haemoglobin decreased 12.12 10.30 156 61432 108219 29404720
Lethargy 12.11 10.30 39 61549 37541 29475398
Wrong dose 12.09 10.30 9 61579 453 29512486
Clostridium difficile colitis 12.04 10.30 57 61531 13155 29499784
Urinary incontinence 11.99 10.30 10 61578 16471 29496468
Syphilis 11.98 10.30 8 61580 338 29512601
Acute hepatic failure 11.96 10.30 53 61535 11899 29501040
Bacterial infection 11.90 10.30 56 61532 12892 29500047
Pneumonia acinetobacter 11.88 10.30 5 61583 80 29512859
Blood glucose increased 11.87 10.30 73 61515 58911 29454028
Pneumonia staphylococcal 11.82 10.30 21 61567 2764 29510175
Rash erythematous 11.70 10.30 81 61507 21481 29491458
Drug level increased 11.67 10.30 73 61515 18714 29494225
Coronavirus test positive 11.57 10.30 8 61580 358 29512581
Dystonia 11.57 10.30 3 61585 9746 29503193
Eye swelling 11.55 10.30 42 61546 8615 29504324
Accidental exposure to product 11.51 10.30 4 61584 10749 29502190
Urosepsis 11.49 10.30 4 61584 10742 29502197
Neurilemmoma benign 11.39 10.30 3 61585 9 29512930
Hypo HDL cholesterolaemia 11.39 10.30 3 61585 9 29512930
Diaphragmatic hernia 11.38 10.30 7 61581 256 29512683
Prostatic specific antigen increased 11.33 10.30 6 61582 12558 29500381
Oropharyngeal candidiasis 11.31 10.30 10 61578 643 29512296
Brain abscess 11.25 10.30 20 61568 2635 29510304
Pulmonary alveolar haemorrhage 11.24 10.30 34 61554 6346 29506593
Tubulointerstitial nephritis 11.23 10.30 69 61519 17574 29495365
Subcutaneous emphysema 11.18 10.30 12 61576 980 29511959
Vertical infection transmission 11.15 10.30 3 61585 10 29512929
Jarisch-Herxheimer reaction 11.15 10.30 8 61580 380 29512559
Inflammatory marker increased 11.12 10.30 24 61564 3643 29509296
Interstitial granulomatous dermatitis 11.11 10.30 6 61582 171 29512768
Dry gangrene 11.09 10.30 8 61580 383 29512556
Rash 11.05 10.30 492 61096 189327 29323612
Multiple sclerosis relapse 10.99 10.30 5 61583 11414 29501525
Pneumonia legionella 10.97 10.30 15 61573 1576 29511363
Memory impairment 10.97 10.30 39 61549 36431 29476508
Neutrophil count decreased 10.95 10.30 50 61538 43517 29469422
Hypogammaglobulinaemia 10.90 10.30 32 61556 5875 29507064
Rash morbilliform 10.84 10.30 19 61569 2474 29510465
Purpura senile 10.73 10.30 3 61585 12 29512927
Abdominal wall haematoma 10.71 10.30 15 61573 1612 29511327
Atypical mycobacterial infection 10.70 10.30 10 61578 691 29512248
Hilar lymphadenopathy 10.68 10.30 11 61577 856 29512083
Bronchospasm 10.68 10.30 44 61544 9565 29503374
Balance disorder 10.66 10.30 39 61549 36131 29476808
Infusion related reaction 10.66 10.30 51 61537 43835 29469104
Delusion 10.65 10.30 5 61583 11211 29501728
Cheilitis 10.60 10.30 17 61571 2059 29510880
Asthmatic crisis 10.57 10.30 8 61580 413 29512526
Laziness 10.56 10.30 7 61581 292 29512647
Acute sinusitis 10.56 10.30 13 61575 1231 29511708
Tremor 10.55 10.30 100 61488 73438 29439501
Infective exacerbation of bronchiectasis 10.52 10.30 8 61580 416 29512523
Lip ulceration 10.48 10.30 10 61578 710 29512229
Dyskinesia 10.43 10.30 16 61572 20045 29492894
Hypocoagulable state 10.36 10.30 11 61577 887 29512052
Urethral discharge 10.35 10.30 3 61585 14 29512925

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 2572.56 9.84 4384 116650 628422 63749276
Infective pulmonary exacerbation of cystic fibrosis 1116.25 9.84 511 120523 11285 64366413
Drug hypersensitivity 672.69 9.84 1419 119615 236396 64141302
Electrocardiogram QT prolonged 564.24 9.84 720 120314 78728 64298970
Abortion incomplete 515.93 9.84 200 120834 2861 64374837
Asthma 378.07 9.84 657 120377 94568 64283130
Completed suicide 304.71 9.84 33 121001 224381 64153317
Cystic fibrosis 300.59 9.84 141 120893 3293 64374405
Product use in unapproved indication 272.76 9.84 839 120195 175779 64201919
Long QT syndrome 230.97 9.84 135 120899 5004 64372694
Bronchiectasis 230.64 9.84 200 120834 13940 64363758
Wheezing 220.35 9.84 475 120559 80104 64297594
Drug interaction 212.25 9.84 1281 119753 360802 64016896
Drug ineffective for unapproved indication 198.85 9.84 268 120766 30865 64346833
Drug abuse 163.93 9.84 26 121008 132348 64245350
Haemoptysis 162.35 9.84 313 120721 48735 64328963
Cough 147.39 9.84 1021 120013 301127 64076571
Joint swelling 142.47 9.84 117 120917 215265 64162433
Fall 139.71 9.84 365 120669 416461 63961237
Pulmonary function test decreased 138.17 9.84 107 120927 6354 64371344
Synovitis 135.86 9.84 14 121020 99076 64278622
Contraindicated product administered 133.91 9.84 21 121013 107808 64269890
Productive cough 133.21 9.84 369 120665 72834 64304864
Drug effective for unapproved indication 132.22 9.84 84 120950 3624 64374074
Cholecystitis chronic 121.35 9.84 116 120918 9171 64368527
Rheumatoid arthritis 119.25 9.84 81 120953 164213 64213485
Obstructive airways disorder 119.19 9.84 180 120854 23005 64354693
Arthralgia 118.50 9.84 429 120605 441831 63935867
Immune reconstitution inflammatory syndrome 118.09 9.84 131 120903 12339 64365359
Toxicity to various agents 112.30 9.84 331 120703 363182 64014516
Sleep disorder due to a general medical condition 111.69 9.84 105 120929 8129 64369569
Hepatitis 109.20 9.84 255 120779 45327 64332371
Injury 108.62 9.84 289 120745 55703 64321995
Sputum discoloured 108.39 9.84 150 120884 17706 64359992
Therapeutic product effect decreased 107.37 9.84 41 120993 115310 64262388
Respiratory failure 105.68 9.84 588 120446 160595 64217103
Torsade de pointes 101.14 9.84 143 120891 17220 64360478
Stevens-Johnson syndrome 100.64 9.84 208 120826 34041 64343657
Hypertransaminasaemia 100.04 9.84 93 120941 7098 64370600
Haemorrhage 96.48 9.84 348 120686 79003 64298695
Infusion related reaction 96.11 9.84 100 120934 164367 64213331
Acute respiratory distress syndrome 94.56 9.84 219 120815 38716 64338982
Breath sounds abnormal 94.37 9.84 113 120921 11556 64366142
Pathogen resistance 94.19 9.84 117 120917 12426 64365272
Fatigue 91.39 9.84 932 120102 747798 63629900
Hand deformity 91.08 9.84 7 121027 62764 64314934
Malignant neoplasm progression 89.73 9.84 50 120984 112821 64264877
Intentional overdose 88.79 9.84 29 121005 89915 64287783
Vanishing bile duct syndrome 86.45 9.84 44 120990 1233 64376465
Premature delivery 85.34 9.84 137 120897 18452 64359246
Pneumonia 84.04 9.84 1495 119539 558081 63819617
Full blood count abnormal 83.10 9.84 177 120857 29580 64348118
COVID-19 80.31 9.84 287 120747 64853 64312845
Emotional distress 78.14 9.84 194 120840 35844 64341854
Forced expiratory volume decreased 77.15 9.84 79 120955 6788 64370910
Cystic fibrosis respiratory infection suppression 76.96 9.84 29 121005 382 64377316
Alopecia 74.94 9.84 122 120912 165568 64212130
Arthropathy 74.75 9.84 70 120964 120897 64256801
Death 74.61 9.84 565 120469 482140 63895558
Somnolence 73.82 9.84 171 120863 203474 64174224
Toxic epidermal necrolysis 73.26 9.84 193 120841 36973 64340725
Systemic lupus erythematosus 73.20 9.84 27 121007 77585 64300113
Solar lentigo 73.01 9.84 35 120999 859 64376839
No adverse event 71.95 9.84 163 120871 28398 64349300
Hypoxia 71.23 9.84 341 120693 87808 64289890
Chronic obstructive pulmonary disease 71.14 9.84 293 120741 70755 64306943
Asthma-chronic obstructive pulmonary disease overlap syndrome 71.07 9.84 37 120997 1088 64376610
Sputum increased 70.84 9.84 57 120977 3578 64374120
Photodermatosis 70.10 9.84 34 121000 857 64376841
Eosinophil count abnormal 70.00 9.84 30 121004 562 64377136
Bronchopulmonary aspergillosis 69.61 9.84 127 120907 18958 64358740
Transaminases increased 68.82 9.84 212 120822 44382 64333316
Condition aggravated 67.64 9.84 1027 120007 371399 64006299
Upper respiratory tract infection 65.04 9.84 290 120744 72495 64305203
Ototoxicity 64.64 9.84 48 120986 2675 64375023
Dysplastic naevus 64.18 9.84 27 121007 482 64377216
Drug-induced liver injury 64.01 9.84 216 120818 47427 64330271
Dyspnoea 63.13 9.84 1779 119255 716895 63660803
Febrile neutropenia 62.97 9.84 164 120870 187493 64190205
Drug reaction with eosinophilia and systemic symptoms 61.05 9.84 232 120802 53985 64323713
Drug intolerance 61.03 9.84 167 120867 187825 64189873
Swelling 60.94 9.84 131 120903 160087 64217611
Drug resistance 60.94 9.84 174 120860 34928 64342770
Wound 60.60 9.84 34 121000 76443 64301255
Glossodynia 58.54 9.84 24 121010 64672 64313026
COVID-19 pneumonia 57.90 9.84 108 120926 16396 64361302
Infective exacerbation of bronchiectasis 57.21 9.84 28 121006 720 64376978
Overdose 57.00 9.84 135 120899 159431 64218267
Biliary dyskinesia 56.73 9.84 42 120992 2330 64375368
Product packaging quantity issue 56.01 9.84 30 121004 936 64376762
Suicide attempt 55.64 9.84 32 121002 70975 64306723
Factor V inhibition 55.49 9.84 22 121012 335 64377363
Alanine aminotransferase increased 54.72 9.84 447 120587 138584 64239114
Confusional state 53.51 9.84 280 120754 260864 64116834
Pseudomonas infection 52.99 9.84 109 120925 17774 64359924
Eosinophilia 52.36 9.84 174 120860 37902 64339796
Congenital hiatus hernia 51.93 9.84 22 121012 400 64377298
Coma 51.46 9.84 53 120981 87562 64290136
Peripheral swelling 51.29 9.84 210 120824 208943 64168755
Bronchopulmonary aspergillosis allergic 51.10 9.84 34 121000 1588 64376110
Mobility decreased 50.34 9.84 52 120982 85788 64291910
Mycobacterium avium complex infection 49.19 9.84 48 120986 3892 64373806
Hepatitis acute 48.71 9.84 89 120945 13300 64364398
Acute respiratory failure 48.46 9.84 204 120830 49730 64327968
Lip oedema 48.25 9.84 54 120980 5135 64372563
Rhinitis allergic 47.74 9.84 67 120967 8011 64369687
COVID-19 treatment 47.47 9.84 21 121013 426 64377272
Pulmonary embolism 46.97 9.84 450 120584 145906 64231792
Exposure during pregnancy 46.68 9.84 277 120757 77398 64300300
Helicobacter infection 46.43 9.84 8 121026 38354 64339344
Dehydration 46.33 9.84 229 120805 216534 64161164
Distal intestinal obstruction syndrome 46.18 9.84 23 121011 615 64377083
Mucocutaneous disorder 46.15 9.84 15 121019 123 64377575
Constipation 45.25 9.84 249 120785 229088 64148610
Myasthenia gravis crisis 44.48 9.84 25 121009 859 64376839
Deafness 44.28 9.84 103 120931 18256 64359442
Obliterative bronchiolitis 44.07 9.84 38 120996 2627 64375071
Hypertriglyceridaemia 43.99 9.84 77 120957 11128 64366570
Pneumothorax 43.69 9.84 122 120912 24176 64353522
Neutropenia 42.59 9.84 269 120765 239355 64138343
Injection site pain 42.43 9.84 91 120943 111317 64266381
Urinary tract infection 42.19 9.84 258 120776 231338 64146360
Lung transplant rejection 42.15 9.84 28 121006 1304 64376394
Acute generalised exanthematous pustulosis 42.02 9.84 86 120948 13972 64363726
Lung opacity 41.87 9.84 40 120994 3159 64374539
Musculoskeletal stiffness 41.83 9.84 107 120927 123099 64254599
Pregnancy 41.77 9.84 109 120925 20756 64356942
Hypofibrinogenaemia 41.44 9.84 31 121003 1747 64375951
Hepatitis cholestatic 40.73 9.84 78 120956 12077 64365621
Bronchiolitis obliterans syndrome 40.10 9.84 16 121018 248 64377450
Blood pressure fluctuation 39.76 9.84 24 121010 51847 64325851
Anosmia 39.42 9.84 45 120989 4372 64373326
Bronchomalacia 39.17 9.84 15 121019 207 64377491
Hepatocellular injury 38.73 9.84 178 120856 45057 64332641
Actinic keratosis 38.49 9.84 48 120986 5117 64372581
Cystic fibrosis related diabetes 38.41 9.84 14 121020 167 64377531
Total lung capacity increased 38.30 9.84 21 121013 687 64377011
Stomatitis 38.13 9.84 94 120940 109511 64268187
Stenotrophomonas infection 37.48 9.84 37 120997 3043 64374655
Chest discomfort 37.25 9.84 357 120677 115749 64261949
Bronchitis 37.21 9.84 339 120695 108404 64269294
Auscultation 36.96 9.84 7 121027 0 64377698
Gastrointestinal haemorrhage 36.88 9.84 126 120908 132186 64245512
Cognitive disorder 36.28 9.84 30 121004 55057 64322641
Respiration abnormal 35.29 9.84 51 120983 6264 64371434
Cholestasis 35.09 9.84 172 120862 44700 64332998
HIV associated nephropathy 34.76 9.84 15 121019 286 64377412
Gallbladder disorder 34.13 9.84 89 120945 16941 64360757
Hypotension 33.86 9.84 507 120527 380467 63997231
Myocardial infarction 33.82 9.84 178 120856 165643 64212055
Herpes simplex viraemia 33.64 9.84 14 121020 243 64377455
Dizziness 33.10 9.84 588 120446 429575 63948123
Injection site erythema 33.06 9.84 51 120983 70749 64306949
Immunodeficiency common variable 32.92 9.84 14 121020 257 64377441
Mycobacterial infection 32.89 9.84 34 121000 2954 64374744
Sleep disorder due to general medical condition, insomnia type 32.86 9.84 5 121029 26265 64351433
Eosinophil count increased 32.75 9.84 78 120956 14034 64363664
Cryptococcal meningoencephalitis 32.73 9.84 13 121021 199 64377499
Nasal polyps 32.44 9.84 37 120997 3592 64374106
Tinnitus 32.00 9.84 138 120896 33995 64343703
Pneumomediastinum 31.92 9.84 33 121001 2867 64374831
Hospitalisation 31.87 9.84 246 120788 74961 64302737
Hyponatraemia 31.51 9.84 157 120877 148182 64229516
Osteonecrosis of jaw 31.12 9.84 18 121016 39807 64337891
Forced expiratory volume 30.87 9.84 10 121024 81 64377617
Discomfort 30.84 9.84 66 120968 80812 64296886
Respiratory disorder 30.84 9.84 142 120892 35969 64341729
Contusion 30.77 9.84 110 120924 113855 64263843
Deafness neurosensory 30.67 9.84 48 120986 6326 64371372
Graft versus host disease in lung 30.64 9.84 19 121015 785 64376913
Injection site swelling 30.50 9.84 20 121014 41333 64336365
Eosinophilic pneumonia 30.13 9.84 40 120994 4537 64373161
Rales 29.92 9.84 79 120955 15150 64362548
Parathyroid gland enlargement 29.89 9.84 11 121023 135 64377563
Pneumonia pseudomonal 29.47 9.84 41 120993 4862 64372836
Cystic fibrosis pancreatic 29.43 9.84 9 121025 59 64377639
General physical health deterioration 29.29 9.84 244 120790 204181 64173517
Pain in extremity 29.15 9.84 397 120637 302688 64075010
Middle lobe syndrome 29.04 9.84 8 121026 34 64377664
Palmar-plantar erythrodysaesthesia syndrome 28.95 9.84 9 121025 28810 64348888
Cytokine storm 28.93 9.84 19 121015 868 64376830
Disease progression 28.38 9.84 153 120881 141527 64236171
Pericarditis 28.27 9.84 46 120988 62470 64315228
Aspergillus infection 28.24 9.84 81 120953 16298 64361400
Sedation 28.03 9.84 22 121012 41440 64336258
Cryptococcosis 27.92 9.84 30 121004 2725 64374973
Metastases to bone 27.71 9.84 3 121031 20432 64357266
Heart sounds 27.52 9.84 16 121018 587 64377111
Pharyngeal erythema 26.92 9.84 24 121010 1735 64375963
Sopor 26.83 9.84 11 121023 29650 64348048
Seizure 26.81 9.84 193 120841 166699 64210999
NPM1 gene mutation 26.66 9.84 10 121024 130 64377568
Liver function test increased 26.61 9.84 122 120912 30848 64346850
Blood pressure increased 26.55 9.84 202 120832 172350 64205348
Factor V deficiency 26.38 9.84 9 121025 87 64377611
Aspartate aminotransferase increased 26.37 9.84 342 120692 119446 64258252
Gait disturbance 26.27 9.84 202 120832 171953 64205745
Mechanical urticaria 26.19 9.84 13 121021 345 64377353
Respiratory tract infection 26.18 9.84 139 120895 37268 64340430
Mixed liver injury 25.99 9.84 41 120993 5440 64372258
Impaired healing 25.96 9.84 46 120988 60427 64317271
Depressed level of consciousness 25.91 9.84 73 120961 81363 64296335
Forced vital capacity decreased 25.85 9.84 22 121012 1494 64376204
Decreased appetite 25.78 9.84 372 120662 280917 64096781
Orthostatic hypotension 25.54 9.84 30 121004 46708 64330990
SJS-TEN overlap 25.29 9.84 14 121020 467 64377231
Oral candidiasis 25.04 9.84 98 120936 23114 64354584
Injection site bruising 24.97 9.84 19 121015 36354 64341344
Agranulocytosis 24.70 9.84 139 120895 38090 64339608
Pneumonia bacterial 24.62 9.84 73 120961 14962 64362736
Hypercapnia 24.11 9.84 48 120986 7646 64370052
Genital ulceration 24.01 9.84 15 121019 628 64377070
Endometritis 23.99 9.84 16 121018 750 64376948
Dysarthria 23.90 9.84 47 120987 59359 64318339
Alveolitis 23.90 9.84 32 121002 3660 64374038
Viral infection 23.74 9.84 132 120902 36008 64341690
Respiratory syncytial virus infection 23.57 9.84 46 120988 7222 64370476
Pneumothorax spontaneous 23.55 9.84 18 121016 1048 64376650
Rash maculo-papular 23.48 9.84 160 120874 46866 64330832
Urethritis mycoplasmal 23.40 9.84 6 121028 18 64377680
Bronchial wall thickening 23.37 9.84 23 121011 1884 64375814
Sputum retention 23.33 9.84 17 121017 920 64376778
Platelet count decreased 23.20 9.84 202 120832 167509 64210189
Iris transillumination defect 23.19 9.84 9 121025 129 64377569
Metastases to liver 23.13 9.84 8 121026 23933 64353765
Hypokalaemia 23.13 9.84 134 120900 121769 64255929
Ventricular tachycardia 23.08 9.84 126 120908 34139 64343559
Cystic fibrosis lung 23.07 9.84 9 121025 131 64377567
Influenza 22.96 9.84 303 120731 106228 64271470
Prolonged expiration 22.95 9.84 16 121018 807 64376891
Bacterial pericarditis 22.88 9.84 7 121027 46 64377652
Knee arthroplasty 22.87 9.84 11 121023 26988 64350710
Chronic kidney disease 22.65 9.84 186 120848 57733 64319965
Irritable bowel syndrome 22.63 9.84 22 121012 37347 64340351
HIV infection 22.62 9.84 17 121017 965 64376733
Headache 22.62 9.84 790 120244 528677 63849021
Neutrophil count decreased 22.55 9.84 72 120962 77124 64300574
Conjunctival hyperaemia 22.54 9.84 32 121002 3867 64373831
Pancreatic failure 22.50 9.84 20 121014 1440 64376258
Device expulsion 22.34 9.84 6 121028 21130 64356568
Cholelithiasis 22.22 9.84 154 120880 45352 64332346
Mucormycosis 22.05 9.84 45 120989 7296 64370402
Upper respiratory fungal infection 22.02 9.84 11 121023 296 64377402
Pneumonia mycoplasmal 21.99 9.84 19 121015 1317 64376381
Injection site haemorrhage 21.97 9.84 9 121025 24269 64353429
Accidental exposure to product 21.94 9.84 11 121023 26353 64351345
Atypical mycobacterial lower respiratory tract infection 21.80 9.84 7 121027 55 64377643
Pharyngeal enanthema 21.80 9.84 7 121027 55 64377643
Rash maculovesicular 21.69 9.84 6 121028 26 64377672
Abdominal discomfort 21.65 9.84 228 120806 182094 64195604
Breast cancer 21.63 9.84 14 121020 29134 64348564
Uterine perforation 21.57 9.84 39 120995 5781 64371917
Asthenia 21.56 9.84 625 120409 427419 63950279
Mucosal inflammation 21.50 9.84 54 120980 62530 64315168
Hepatic enzyme increased 21.49 9.84 149 120885 129794 64247904
Injection site reaction 21.41 9.84 34 121000 46630 64331068
Pulmonary function test abnormal 21.37 9.84 28 121006 3136 64374562
Granulomatosis with polyangiitis 21.34 9.84 23 121011 2097 64375601
Cardiac failure 21.29 9.84 153 120881 132220 64245478
Methaemoglobinaemia 21.28 9.84 33 121001 4315 64373383
Lung transplant 21.26 9.84 32 121002 4076 64373622
Meningism 20.90 9.84 13 121021 540 64377158
Hyperbilirubinaemia 20.86 9.84 87 120947 21118 64356580
Lung infiltration 20.78 9.84 86 120948 20803 64356895
Lung diffusion disorder 20.72 9.84 8 121026 113 64377585
Pneumonia aspiration 20.47 9.84 51 120983 59220 64318478
Pain 20.30 9.84 841 120193 552670 63825028
Tachypnoea 20.17 9.84 101 120933 26470 64351228
Chimerism 20.12 9.84 10 121024 266 64377432
Rheumatoid factor 20.11 9.84 8 121026 123 64377575
Anhedonia 20.07 9.84 64 120970 13642 64364056
Erythema multiforme 20.04 9.84 70 120964 15631 64362067
Blood immunoglobulin E increased 19.97 9.84 30 121004 3814 64373884
Drug level increased 19.93 9.84 121 120913 34075 64343623
Cerebral infarction 19.70 9.84 29 121005 41015 64336683
Total lung capacity decreased 19.69 9.84 20 121014 1702 64375996
Symmetrical drug-related intertriginous and flexural exanthema 19.52 9.84 13 121021 608 64377090
Joint stiffness 19.48 9.84 17 121017 30387 64347311
Small intestinal obstruction 19.37 9.84 10 121024 23563 64354135
Lung hyperinflation 18.94 9.84 19 121015 1593 64376105
Pelvic inflammatory disease 18.92 9.84 17 121017 1241 64376457
White blood cell count decreased 18.89 9.84 197 120837 157640 64220058
Dystonia 18.76 9.84 6 121028 18859 64358839
Cardiac arrest 18.70 9.84 399 120635 153665 64224033
Fracture 18.58 9.84 6 121028 18749 64358949
Antinuclear antibody negative 18.39 9.84 5 121029 20 64377678
Andersen-Tawil syndrome 18.36 9.84 4 121030 4 64377694
Bacterial infection 18.35 9.84 94 120940 24856 64352842
Pseudomembranous colitis 18.29 9.84 33 121001 4883 64372815
Gallbladder cholesterolosis 18.22 9.84 12 121022 551 64377147
Localised infection 17.98 9.84 18 121016 30143 64347555
Pulmonary infarction 17.97 9.84 26 121008 3196 64374502
Multiple sclerosis relapse 17.92 9.84 31 121003 41104 64336594
C-reactive protein abnormal 17.71 9.84 17 121017 29030 64348668
Restrictive allograft syndrome 17.66 9.84 5 121029 24 64377674
Noninfective conjunctivitis 17.49 9.84 5 121029 25 64377673
Urethral discharge 17.47 9.84 4 121030 6 64377692
Urticaria 17.39 9.84 380 120654 146937 64230761
Carbon dioxide increased 17.31 9.84 20 121014 1969 64375729
Interstitial lung disease 17.19 9.84 110 120924 97622 64280076
Tubulointerstitial nephritis 17.15 9.84 108 120926 30801 64346897
Gastroenteritis staphylococcal 17.09 9.84 9 121025 271 64377427
Crystal arthropathy 17.08 9.84 8 121026 186 64377512
Blood immunoglobulin G decreased 16.98 9.84 23 121011 2660 64375038
Hypoglycaemia 16.95 9.84 99 120935 89793 64287905
Pneumonia staphylococcal 16.93 9.84 30 121004 4376 64373322
Prostate cancer 16.87 9.84 8 121026 19787 64357911
Enterovirus infection 16.80 9.84 17 121017 1440 64376258
Lung disorder 16.75 9.84 181 120853 60519 64317179
Infective chondritis 16.73 9.84 5 121029 30 64377668
Balance disorder 16.60 9.84 91 120943 83835 64293863
Weight increased 16.57 9.84 291 120743 213057 64164641
Fluid retention 16.44 9.84 57 120977 59549 64318149
Therapeutic response decreased 16.44 9.84 47 120987 52141 64325557
Pancreatitis acute 16.42 9.84 137 120897 42718 64334980
Hepatomegaly 16.40 9.84 69 120965 16813 64360885
Heart rate decreased 16.33 9.84 51 120983 55016 64322682
Gallbladder injury 16.26 9.84 15 121019 1133 64376565
Ventricular fibrillation 16.24 9.84 88 120946 23772 64353926
Kawasaki's disease 16.13 9.84 4 121030 10 64377688
Gastrooesophageal reflux disease 16.09 9.84 232 120802 82911 64294787
Wrong technique in product usage process 16.05 9.84 65 120969 64909 64312789
Cardiac failure congestive 16.03 9.84 162 120872 130418 64247280
HIV viraemia 15.99 9.84 6 121028 78 64377620
Ascites 15.97 9.84 61 120973 61940 64315758
Peak expiratory flow rate abnormal 15.92 9.84 6 121028 79 64377619
Portal hypertensive enteropathy 15.84 9.84 3 121031 0 64377698
Thoracic cavity drainage test abnormal 15.84 9.84 3 121031 0 64377698
Bronchogram abnormal 15.84 9.84 3 121031 0 64377698
Purpura 15.61 9.84 69 120965 17177 64360521
Flank pain 15.59 9.84 66 120968 16123 64361575
Poisoning 15.57 9.84 11 121023 21868 64355830
Acoustic neuroma 15.56 9.84 8 121026 229 64377469
Nasal mucosal disorder 15.46 9.84 9 121025 331 64377367
Hyperaemia 15.32 9.84 22 121012 2687 64375011
Rash pustular 15.25 9.84 47 120987 9838 64367860
Adverse event 15.24 9.84 32 121002 39457 64338241
Total lung capacity abnormal 15.22 9.84 7 121027 156 64377542
Leukocytosis 15.18 9.84 122 120912 37618 64340080
Lip erythema 15.14 9.84 7 121027 158 64377540
Foot deformity 15.13 9.84 6 121028 16498 64361200
Pigment nephropathy 15.07 9.84 5 121029 44 64377654
Anaemia 15.01 9.84 570 120464 378110 63999588
Blood glucose increased 14.98 9.84 115 120919 97958 64279740
Product prescribing error 14.98 9.84 27 121007 35242 64342456
Gonorrhoea 14.94 9.84 7 121027 163 64377535
Pneumonia necrotising 14.94 9.84 13 121021 910 64376788
Sinus congestion 14.92 9.84 63 120971 15376 64362322
Hepatotoxicity 14.91 9.84 127 120907 39835 64337863
Abdominal wall haematoma 14.88 9.84 28 121006 4277 64373421
Red blood cell sedimentation rate abnormal 14.83 9.84 6 121028 16300 64361398
Amniotic cavity infection 14.79 9.84 12 121022 762 64376936
Haemolysis 14.78 9.84 50 120984 10989 64366709
Joint range of motion decreased 14.75 9.84 9 121025 19334 64358364
Lower gastrointestinal haemorrhage 14.65 9.84 4 121030 13935 64363763
Urosepsis 14.59 9.84 12 121022 22082 64355616
Respiratory tract inflammation 14.58 9.84 12 121022 778 64376920
End stage renal disease 14.51 9.84 48 120986 10427 64367271
Increased bronchial secretion 14.51 9.84 22 121012 2820 64374878
Oesophagogastroduodenoscopy 14.48 9.84 7 121027 175 64377523
Hypertension 14.47 9.84 373 120661 258888 64118810
Diabetic ketoacidosis 14.41 9.84 21 121013 29824 64347874
Hyperkalaemia 14.34 9.84 121 120913 101008 64276690
Asthmatic crisis 14.19 9.84 17 121017 1739 64375959
Hilar lymphadenopathy 14.16 9.84 16 121018 1537 64376161
Alcohol intolerance 14.15 9.84 9 121025 389 64377309
Fungal disease carrier 14.13 9.84 8 121026 279 64377419
Mycoplasma infection 14.12 9.84 11 121023 659 64377039
Multiple-drug resistance 14.09 9.84 35 120999 6467 64371231
Bacterial disease carrier 14.05 9.84 13 121021 986 64376712
Disseminated cryptococcosis 14.05 9.84 16 121018 1551 64376147
Herpes zoster 13.99 9.84 89 120945 79098 64298600
Staphylococcus test positive 13.97 9.84 32 121002 5613 64372085
Injection site warmth 13.89 9.84 4 121030 13458 64364240
Jarisch-Herxheimer reaction 13.87 9.84 11 121023 676 64377022
Therapeutic product effect incomplete 13.87 9.84 272 120762 103210 64274488
Senile pruritus 13.77 9.84 3 121031 3 64377695
Subcutaneous emphysema 13.70 9.84 16 121018 1593 64376105
Disorientation 13.70 9.84 56 120978 55772 64321926
Extrapyramidal disorder 13.69 9.84 10 121024 19542 64358156
Q fever 13.66 9.84 7 121027 199 64377499
Blood pressure diastolic decreased 13.65 9.84 13 121021 22288 64355410
Tachyarrhythmia 13.65 9.84 33 121001 5993 64371705
Bronchial hyperreactivity 13.62 9.84 20 121014 2492 64375206
Haematemesis 13.61 9.84 44 120990 46955 64330743
Interleukin level increased 13.59 9.84 9 121025 417 64377281
Delusional disorder, persecutory type 13.59 9.84 9 121025 417 64377281
Mycoplasma test positive 13.57 9.84 7 121027 202 64377496
Hallucinations, mixed 13.56 9.84 33 121001 6019 64371679
Dyshidrotic eczema 13.55 9.84 10 121024 552 64377146
Bronchial secretion retention 13.53 9.84 20 121014 2507 64375191
Catastrophic reaction 13.53 9.84 4 121030 23 64377675
Kounis syndrome 13.48 9.84 22 121012 3003 64374695
Nosocomial infection 13.47 9.84 20 121014 2517 64375181
Respiratory tract congestion 13.38 9.84 63 120971 16102 64361596
Pleural fistula 13.38 9.84 4 121030 24 64377674
Haemorrhoids thrombosed 13.38 9.84 7 121027 208 64377490
Liver function test 13.37 9.84 6 121028 126 64377572
Blister 13.30 9.84 93 120941 80874 64296824
Dysbiosis 13.28 9.84 12 121022 883 64376815
Leukaemoid reaction 13.27 9.84 8 121026 314 64377384
Muscular weakness 13.25 9.84 164 120870 127174 64250524
Bronchial disorder 13.18 9.84 18 121016 2097 64375601
Pneumonia acinetobacter 13.16 9.84 6 121028 131 64377567
Hip fracture 13.15 9.84 19 121015 27080 64350618
Eye swelling 13.08 9.84 79 120955 22202 64355496
Acute sinusitis 13.06 9.84 26 121008 4140 64373558
Deafness unilateral 12.98 9.84 24 121010 3618 64374080
Deep vein thrombosis 12.95 9.84 273 120761 104909 64272789
Oral mucosa erosion 12.94 9.84 16 121018 1691 64376007
Poor feeding infant 12.91 9.84 6 121028 137 64377561
Hepatosplenomegaly 12.91 9.84 30 121004 5313 64372385
Respiratory depression 12.86 9.84 15 121019 23428 64354270
Hepatic necrosis 12.81 9.84 40 120994 8433 64369265
Laryngeal mass 12.80 9.84 5 121029 73 64377625
Humidity intolerance 12.76 9.84 8 121026 337 64377361
Basal cell carcinoma 12.75 9.84 24 121010 30814 64346884
Treatment failure 12.70 9.84 149 120885 116667 64261031
Macule 12.70 9.84 19 121015 2407 64375291
Toxic optic neuropathy 12.70 9.84 12 121022 935 64376763
Cerebral haemorrhage 12.69 9.84 51 120983 51039 64326659
Pneumopericardium 12.68 9.84 6 121028 143 64377555
Syphilis 12.65 9.84 9 121025 469 64377229
Clostridium difficile colitis 12.63 9.84 91 120943 27132 64350566
Immunosuppressant drug level increased 12.61 9.84 36 120998 7223 64370475
Joint dislocation 12.61 9.84 3 121031 11462 64366236
Flushing 12.60 9.84 91 120943 78557 64299141
Pneumonia legionella 12.58 9.84 19 121015 2427 64375271
Urinary incontinence 12.57 9.84 31 121003 36120 64341578
Virologic failure 12.56 9.84 23 121011 3443 64374255
Myasthenia gravis 12.55 9.84 31 121003 5707 64371991
Secretion discharge 12.49 9.84 50 120984 11914 64365784
Device malfunction 12.37 9.84 9 121025 17624 64360074
Muscle spasticity 12.37 9.84 8 121026 16661 64361037
Local reaction 12.37 9.84 9 121025 486 64377212
Stomatococcal infection 12.36 9.84 7 121027 244 64377454
Hypogammaglobulinaemia 12.36 9.84 45 120989 10254 64367444
Febrile bone marrow aplasia 12.27 9.84 3 121031 11252 64366446
ADAMTS13 activity decreased 12.23 9.84 6 121028 155 64377543
Cheilitis 12.20 9.84 27 121007 4629 64373069
Appetite disorder 12.17 9.84 33 121001 6428 64371270
Haemolytic anaemia 12.17 9.84 61 120973 15992 64361706
Rhinovirus infection 12.16 9.84 32 121002 6124 64371574
Borderline personality disorder 12.13 9.84 11 121023 813 64376885
Second primary malignancy 12.13 9.84 4 121030 12333 64365365
Lethargy 12.11 9.84 83 120951 72511 64305187
Musculoskeletal pain 12.10 9.84 96 120938 81198 64296500
Palatal oedema 12.07 9.84 13 121021 1184 64376514
Rash erythematous 12.05 9.84 142 120892 48491 64329207
Oropharyngeal pain 12.05 9.84 234 120800 88633 64289065
Altered state of consciousness 12.04 9.84 34 121000 37868 64339830
Gait inability 12.03 9.84 40 120994 42328 64335370
Neurological examination abnormal 12.03 9.84 9 121025 507 64377191
Ruptured ectopic pregnancy 11.98 9.84 8 121026 376 64377322
Parkinsonism 11.96 9.84 6 121028 14367 64363331
Foetal death 11.89 9.84 31 121003 5899 64371799
Miosis 11.87 9.84 5 121029 13261 64364437
Oesophageal carcinoma 11.87 9.84 27 121007 4716 64372982
Pyrexia 11.84 9.84 1209 119825 557435 63820263
Eosinophilic pleural effusion 11.82 9.84 7 121027 266 64377432
Bladder cancer 11.82 9.84 3 121031 10971 64366727
Hemianopia heteronymous 11.75 9.84 5 121029 92 64377606
Diffuse panbronchiolitis 11.70 9.84 3 121031 9 64377689
Hypo HDL cholesterolaemia 11.70 9.84 3 121031 9 64377689
Cystic fibrosis hepatic disease 11.69 9.84 4 121030 39 64377659
Ischaemic stroke 11.65 9.84 23 121011 29012 64348686
CD4 lymphocytes increased 11.63 9.84 7 121027 274 64377424
Mucocutaneous candidiasis 11.60 9.84 4 121030 40 64377658
Coinfection 11.60 9.84 4 121030 40 64377658
Mycobacterium chelonae infection 11.57 9.84 17 121017 2120 64375578
Bronchospasm 11.56 9.84 75 120959 21607 64356091
Biopsy colon abnormal 11.55 9.84 5 121029 96 64377602
Head injury 11.54 9.84 28 121006 32814 64344884
Maternal exposure during pregnancy 11.52 9.84 248 120786 95636 64282062
Skin ulcer 11.50 9.84 43 120991 43931 64333767
Bone pain 11.50 9.84 48 120986 47524 64330174
Red blood cell sedimentation rate increased 11.48 9.84 26 121008 31209 64346489
Multiple organ dysfunction syndrome 11.46 9.84 260 120774 101153 64276545
Sinus operation 11.45 9.84 15 121019 1680 64376018
Veillonella infection 11.43 9.84 4 121030 42 64377656
Neoplasm progression 11.41 9.84 39 120995 40925 64336773
Lactic acidosis 11.38 9.84 68 120966 61342 64316356
Severe acute respiratory syndrome 11.32 9.84 5 121029 101 64377597
Haemoglobin decreased 11.32 9.84 279 120755 194784 64182914
Diverticulitis 11.29 9.84 36 120998 38582 64339116
Disseminated mycobacterium avium complex infection 11.28 9.84 5 121029 102 64377596
Renal injury 11.25 9.84 58 120976 15371 64362327
Glucose tolerance impaired 11.24 9.84 32 121002 6411 64371287
Vascular parkinsonism 11.23 9.84 5 121029 103 64377595
Pain in jaw 11.22 9.84 39 120995 40716 64336982
Interleukin-2 receptor increased 11.21 9.84 6 121028 187 64377511
Arthritis 11.12 9.84 102 120932 83712 64293986
Eosinophilic pustular folliculitis 11.06 9.84 5 121029 107 64377591
Skin disorder 11.05 9.84 22 121012 27658 64350040
Papillary muscle rupture 11.04 9.84 3 121031 12 64377686
Neurilemmoma benign 11.04 9.84 3 121031 12 64377686
Pneumonia serratia 11.04 9.84 3 121031 12 64377686
Dyspnoea exertional 10.99 9.84 197 120837 73533 64304165
Anxiety 10.96 9.84 475 120559 202174 64175524
Intentional product misuse 10.94 9.84 85 120949 72210 64305488
Muscle rigidity 10.92 9.84 10 121024 17463 64360235
Infusion site streaking 10.88 9.84 8 121026 439 64377259
Pancreatic carcinoma 10.86 9.84 3 121031 10370 64367328
Legionella test positive 10.84 9.84 3 121031 13 64377685
Angina bullosa haemorrhagica 10.84 9.84 6 121028 200 64377498
Ectopic pregnancy 10.81 9.84 14 121020 1550 64376148
Linear IgA disease 10.81 9.84 19 121015 2755 64374943
Coronavirus test positive 10.79 9.84 11 121023 940 64376758
Osteonecrosis 10.79 9.84 23 121011 28206 64349492
Osteoarthritis 10.77 9.84 72 120962 63264 64314434
Infection reactivation 10.77 9.84 16 121018 2014 64375684
Anticoagulation drug level above therapeutic 10.77 9.84 20 121014 3025 64374673
Underdose 10.77 9.84 20 121014 25809 64351889
Chronic sinusitis 10.73 9.84 31 121003 6261 64371437
Laryngeal pain 10.73 9.84 29 121005 5639 64372059
Bronchopleural fistula 10.70 9.84 9 121025 601 64377097
Status epilepticus 10.70 9.84 15 121019 21648 64356050
Rotavirus infection 10.67 9.84 9 121025 604 64377094
Tooth discolouration 10.66 9.84 11 121023 954 64376744
Injection site mass 10.65 9.84 10 121024 17260 64360438
Gallbladder hypofunction 10.65 9.84 8 121026 454 64377244
Glucose-6-phosphate dehydrogenase deficiency 10.58 9.84 7 121027 324 64377374
Cerebral toxoplasmosis 10.58 9.84 15 121019 1811 64375887
Cerebrovascular accident 10.56 9.84 188 120846 137395 64240303
Sensory loss 10.53 9.84 3 121031 10166 64367532
Respiratory distress 10.51 9.84 147 120887 52184 64325514
Ureteric perforation 10.49 9.84 3 121031 15 64377683
Conjunctivochalasis 10.49 9.84 3 121031 15 64377683
Graft infection 10.44 9.84 9 121025 622 64377076
Interstitial granulomatous dermatitis 10.42 9.84 6 121028 216 64377482
Product colour issue 10.41 9.84 9 121025 624 64377074
Superinfection bacterial 10.41 9.84 12 121022 1178 64376520
Epidermolysis 10.37 9.84 8 121026 472 64377226
Occupational exposure to air contaminants 10.35 9.84 5 121029 125 64377573
C-reactive protein increased 10.34 9.84 121 120913 94788 64282910
Inappropriate schedule of product administration 10.31 9.84 117 120917 92169 64285529
Rhinocerebral mucormycosis 10.24 9.84 8 121026 481 64377217
Bronchial obstruction 10.22 9.84 17 121017 2357 64375341
Drug screen false positive 10.22 9.84 11 121023 1001 64376697
Procedural anxiety 10.22 9.84 9 121025 640 64377058
Disturbance in attention 10.20 9.84 41 120993 41033 64336665
Acute kidney injury 10.20 9.84 977 120057 448263 63929435
Vulvovaginal candidiasis 10.19 9.84 16 121018 2114 64375584
Atrial conduction time prolongation 10.18 9.84 3 121031 17 64377681
Suicidal ideation 10.17 9.84 78 120956 66464 64311234
Mediastinal shift 10.14 9.84 4 121030 60 64377638
Acute psychosis 10.11 9.84 22 121012 3730 64373968
Loss of consciousness 10.08 9.84 207 120827 148158 64229540
Opportunistic infection 10.07 9.84 18 121016 2644 64375054
Vitamin E decreased 10.04 9.84 3 121031 18 64377680
Brain hypoxia 9.98 9.84 10 121024 837 64376861
Abortion spontaneous 9.96 9.84 81 120953 25062 64352636
Eosinophilic pneumonia chronic 9.96 9.84 7 121027 358 64377340
Bulimia nervosa 9.94 9.84 6 121028 236 64377462
Malignant melanoma 9.93 9.84 6 121028 12958 64364740
Spinal stenosis 9.92 9.84 7 121027 13924 64363774
Urinary retention 9.92 9.84 53 120981 49148 64328550
Meibomianitis 9.91 9.84 4 121030 64 64377634
Neisseria infection 9.91 9.84 4 121030 64 64377634
Anal skin tags 9.90 9.84 7 121027 361 64377337

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 (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




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 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
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
4020019 VANDF
4020964 VANDF
6197 INN_ID
387531004 SNOMEDCT_US
391805000 SNOMEDCT_US
734459003 SNOMEDCT_US
785687007 SNOMEDCT_US
96034006 SNOMEDCT_US
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 0069-3070 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 0069-3120 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 0069-3140 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 0069-9500 TABLET, FILM COATED 250 mg ORAL UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE 32 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2026 POWDER, FOR SUSPENSION 200 mg ORAL ANDA 27 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2027 POWDER, FOR SUSPENSION 100 mg ORAL ANDA 27 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0409-0144 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 27 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0409-0144 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 27 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0409-0144 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 27 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0409-0144 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 27 sections
azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0527-2370 TABLET, FILM COATED 250 mg ORAL ANDA 28 sections