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) 4 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 0.07 mg/mL Bocci G, Oprea TI, Benet LZ
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 1374.75 10.01 2093 102752 308594 63075583
Infective pulmonary exacerbation of cystic fibrosis 784.34 10.01 352 104493 8465 63375712
Abortion incomplete 536.42 10.01 200 104645 2931 63381246
Off label use 525.04 10.01 2349 102496 672113 62712064
Premature delivery 403.07 10.01 361 104484 29920 63354257
Macular degeneration 335.13 10.01 296 104549 24080 63360097
Asthma 315.74 10.01 669 104176 126892 63257285
Contraindicated product administered 297.34 10.01 15 104830 217633 63166544
Cystic fibrosis 278.55 10.01 127 104718 3169 63381008
Normal labour 270.53 10.01 77 104768 440 63383737
Electrocardiogram QT prolonged 261.50 10.01 401 104444 59129 63325048
Joint swelling 244.26 10.01 118 104727 327548 63056629
Hand deformity 238.82 10.01 5 104840 159452 63224725
Synovitis 237.11 10.01 19 104826 186899 63197278
Wheezing 229.10 10.01 495 104350 95100 63289077
Abortion spontaneous 228.84 10.01 333 104512 46862 63337315
Delivery 223.56 10.01 85 104760 1318 63382859
Arthropathy 208.94 10.01 64 104781 234728 63149449
Bronchiectasis 204.07 10.01 187 104658 15955 63368222
Systemic lupus erythematosus 202.75 10.01 48 104797 208870 63175307
Glossodynia 201.76 10.01 28 104817 178848 63205329
Cough 197.12 10.01 980 103865 291763 63092414
Product use in unapproved indication 196.21 10.01 696 104149 178384 63205793
Nasal polyps 196.05 10.01 123 104722 5916 63378261
Completed suicide 192.84 10.01 12 104833 145661 63238516
Therapeutic product effect decreased 180.46 10.01 48 104797 193139 63191038
Anti-cyclic citrullinated peptide antibody positive 176.61 10.01 3 104842 116209 63267968
Alopecia 173.49 10.01 181 104664 337355 63046822
Drug ineffective for unapproved indication 167.52 10.01 242 104603 33821 63350356
Arthralgia 158.62 10.01 452 104393 569258 62814919
Rhinitis allergic 158.36 10.01 141 104704 11586 63372591
Cholecystitis chronic 156.92 10.01 133 104712 10228 63373949
Pericarditis 149.76 10.01 20 104825 131559 63252618
Wound 144.29 10.01 45 104800 163218 63220959
Sputum discoloured 141.23 10.01 154 104691 16193 63367984
Productive cough 140.85 10.01 318 104527 62890 63321287
Haemorrhage 137.09 10.01 308 104537 60714 63323463
Exposure during pregnancy 131.42 10.01 557 104288 154990 63229187
No adverse event 131.13 10.01 241 104604 41164 63343013
Helicobacter infection 127.89 10.01 6 104839 92779 63291398
Rheumatoid factor positive 124.96 10.01 3 104842 84403 63299774
Rheumatoid arthritis 124.91 10.01 141 104704 253678 63130499
Asthma-chronic obstructive pulmonary disease overlap syndrome 124.28 10.01 63 104782 1998 63382179
Swelling 122.88 10.01 165 104680 275213 63108964
Product packaging quantity issue 120.01 10.01 54 104791 1305 63382872
Sleep disorder due to a general medical condition 114.43 10.01 120 104725 12068 63372109
Haemoptysis 110.24 10.01 182 104663 28544 63355633
Total lung capacity increased 109.16 10.01 60 104785 2250 63381927
Emotional distress 105.01 10.01 191 104654 32358 63351819
Chronic sinusitis 104.06 10.01 117 104728 12726 63371451
Pneumonia 101.40 10.01 1176 103669 455591 62928586
Abdominal discomfort 101.01 10.01 239 104606 320646 63063531
Maternal exposure during pregnancy 100.07 10.01 664 104181 219398 63164779
Treatment failure 99.62 10.01 109 104736 198934 63185243
Upper respiratory tract infection 95.89 10.01 326 104519 81721 63302456
Muscle injury 94.21 10.01 3 104842 65342 63318835
Discomfort 93.73 10.01 83 104762 167291 63216886
Folliculitis 92.40 10.01 6 104839 70311 63313866
Hypoxia 91.57 10.01 261 104584 59531 63324646
Mobility decreased 91.09 10.01 43 104802 121116 63263061
Pulmonary function test abnormal 90.54 10.01 49 104796 1781 63382396
Hepatic enzyme increased 89.42 10.01 122 104723 202206 63181971
Eosinophilia 88.43 10.01 145 104700 22611 63361566
Pulmonary function test decreased 86.45 10.01 63 104782 3884 63380293
Infusion related reaction 86.22 10.01 172 104673 245349 63138828
Impaired healing 85.79 10.01 31 104814 102511 63281666
Peripheral swelling 82.92 10.01 199 104646 265743 63118434
Full blood count abnormal 82.59 10.01 170 104675 31547 63352630
Chronic obstructive pulmonary disease 82.16 10.01 259 104586 62427 63321750
Injury 82.07 10.01 287 104558 72960 63311217
Drug intolerance 79.82 10.01 253 104592 308408 63075769
Bronchitis 79.46 10.01 412 104433 124523 63259654
Breath sounds abnormal 78.90 10.01 94 104751 10879 63373298
Rales 78.78 10.01 101 104744 12596 63371581
Fatigue 78.23 10.01 1017 103828 887011 62497166
Long QT syndrome 75.62 10.01 54 104791 3225 63380952
Biliary dyskinesia 72.44 10.01 49 104796 2680 63381497
Cholelithiasis 71.44 10.01 196 104649 43729 63340448
Upper-airway cough syndrome 71.12 10.01 91 104754 11327 63372850
Obstructive airways disorder 70.01 10.01 124 104721 20575 63363602
Sleep disorder due to general medical condition, insomnia type 69.98 10.01 4 104841 52213 63331964
Drug abuse 69.62 10.01 17 104828 72501 63311676
Chest X-ray abnormal 68.07 10.01 58 104787 4491 63379686
Infective exacerbation of bronchiectasis 65.81 10.01 24 104821 329 63383848
Toxicity to various agents 65.77 10.01 200 104645 247050 63137127
Deafness 65.20 10.01 111 104734 17846 63366331
Sarcoidosis 64.86 10.01 69 104776 7053 63377124
Respiratory failure 64.83 10.01 336 104509 101522 63282655
Blister 63.91 10.01 72 104773 129742 63254435
Pathogen resistance 63.67 10.01 65 104780 6333 63377844
Drug interaction 62.85 10.01 616 104229 228515 63155662
Cystic fibrosis respiratory infection suppression 61.88 10.01 22 104823 279 63383898
Lung opacity 61.43 10.01 47 104798 3121 63381056
Pulmonary embolism 60.36 10.01 364 104481 116320 63267857
Chest discomfort 60.07 10.01 348 104497 109621 63274556
Ear pruritus 58.20 10.01 50 104795 3915 63380262
Death 58.08 10.01 371 104474 374010 63010167
Fall 57.74 10.01 395 104450 391939 62992238
Acute generalised exanthematous pustulosis 56.23 10.01 80 104765 11019 63373158
Rheumatic fever 55.70 10.01 4 104841 43107 63341070
Ototoxicity 55.22 10.01 32 104813 1330 63382847
Irritable bowel syndrome 54.99 10.01 34 104811 82378 63301799
Dyspnoea 54.61 10.01 1453 103392 659860 62724317
Product use issue 54.03 10.01 185 104660 220335 63163842
Bronchopulmonary aspergillosis allergic 53.95 10.01 38 104807 2220 63381957
Stevens-Johnson syndrome 53.86 10.01 124 104721 24826 63359351
Confusional state 53.49 10.01 205 104640 236175 63148002
Malignant neoplasm progression 53.26 10.01 35 104810 82086 63302091
Intentional overdose 53.18 10.01 28 104817 74124 63310053
Torsade de pointes 53.13 10.01 86 104759 13265 63370912
Total lung capacity decreased 52.77 10.01 37 104808 2146 63382031
Factor V inhibition 52.46 10.01 17 104828 159 63384018
Musculoskeletal stiffness 52.24 10.01 145 104700 184473 63199704
Product dose omission issue 51.68 10.01 603 104242 233710 63150467
Anosmia 51.36 10.01 60 104785 6800 63377377
Ventilation perfusion mismatch 50.30 10.01 22 104823 496 63383681
Forced expiratory volume decreased 48.58 10.01 50 104795 4918 63379259
Chronic kidney disease 48.37 10.01 175 104670 45223 63338954
Gallbladder disorder 47.89 10.01 100 104745 18742 63365435
Low birth weight baby 47.88 10.01 59 104786 7070 63377107
Oral candidiasis 47.78 10.01 112 104733 22686 63361491
Product quality issue 47.73 10.01 149 104696 35716 63348461
Procedural pain 47.44 10.01 108 104737 21461 63362716
Stomatitis 47.11 10.01 99 104746 138626 63245551
Paraesthesia oral 46.39 10.01 100 104745 19156 63365021
Respiratory tract infection 45.98 10.01 162 104683 41321 63342856
Prolonged expiration 45.10 10.01 26 104819 1070 63383107
Heart sounds 44.68 10.01 25 104820 971 63383206
Bronchial wall thickening 42.40 10.01 28 104817 1471 63382706
Hip arthroplasty 42.30 10.01 13 104832 47633 63336544
Blood lactic acid increased 41.83 10.01 55 104790 7031 63377146
Type 2 diabetes mellitus 41.71 10.01 27 104818 63841 63320336
Alveolitis 41.25 10.01 36 104809 2879 63381298
Lip oedema 41.12 10.01 41 104804 3883 63380294
Drug resistance 40.99 10.01 106 104739 22827 63361350
Bronchopulmonary aspergillosis 40.48 10.01 60 104785 8575 63375602
Pseudomonas infection 40.29 10.01 69 104776 11144 63373033
Eosinophil count increased 40.27 10.01 68 104777 10860 63373317
Cardiac murmur 40.26 10.01 80 104765 14472 63369705
Tinnitus 40.23 10.01 140 104705 35488 63348689
Respiration abnormal 39.74 10.01 51 104794 6366 63377811
Psoriatic arthropathy 39.58 10.01 56 104789 91464 63292713
Knee arthroplasty 39.57 10.01 20 104825 54186 63329991
Drug reaction with eosinophilia and systemic symptoms 39.12 10.01 134 104711 33702 63350475
Eosinophilic pneumonia 38.96 10.01 31 104814 2180 63381997
C-reactive protein abnormal 38.44 10.01 14 104831 46082 63338095
Rhinorrhoea 38.08 10.01 211 104634 65366 63318811
Nasal congestion 37.95 10.01 211 104634 65449 63318728
Myasthenia gravis crisis 37.89 10.01 18 104827 494 63383683
Auscultation 37.86 10.01 7 104838 0 63384177
COVID-19 37.55 10.01 317 104528 112786 63271391
Mycobacterium avium complex infection 37.52 10.01 35 104810 3053 63381124
Joint range of motion decreased 36.71 10.01 5 104840 32423 63351754
Impaired quality of life 36.02 10.01 74 104771 13709 63370468
Device expulsion 35.92 10.01 7 104838 34915 63349262
Hallucinations, mixed 35.76 10.01 42 104803 4787 63379390
Vaginal flatulence 35.61 10.01 35 104810 3258 63380919
Symmetrical drug-related intertriginous and flexural exanthema 35.12 10.01 17 104828 487 63383690
Urticaria 34.90 10.01 423 104422 165379 63218798
Flank pain 34.80 10.01 81 104764 16329 63367848
Overdose 34.34 10.01 88 104757 114990 63269187
Transaminases increased 34.33 10.01 122 104723 31245 63352932
Premature baby 34.18 10.01 93 104752 20642 63363535
Dysbiosis 33.35 10.01 20 104825 886 63383291
Ventricular fibrillation 32.54 10.01 65 104780 11802 63372375
Somnolence 32.53 10.01 168 104677 178517 63205660
Pneumothorax spontaneous 32.24 10.01 19 104826 815 63383362
Fibromyalgia 32.08 10.01 52 104793 80368 63303809
Jaundice cholestatic 31.66 10.01 49 104796 7275 63376902
Toxic epidermal necrolysis 31.65 10.01 103 104742 25231 63358946
Pneumomediastinum 31.63 10.01 23 104822 1413 63382764
Blood cholesterol increased 31.17 10.01 68 104777 93964 63290213
Drug-induced liver injury 30.83 10.01 140 104705 40082 63344095
Platelet count increased 30.77 10.01 81 104764 17630 63366547
Cystic fibrosis pancreatic 30.57 10.01 9 104836 59 63384118
Liver injury 30.40 10.01 33 104812 60487 63323690
Congenital absence of cranial vault 30.19 10.01 7 104838 14 63384163
Kounis syndrome 29.94 10.01 24 104821 1706 63382471
Oropharyngeal pain 29.87 10.01 262 104583 94225 63289952
Middle lobe syndrome 29.87 10.01 8 104837 35 63384142
Acute respiratory distress syndrome 29.69 10.01 96 104749 23438 63360739
Hypersensitivity 29.47 10.01 325 104520 292360 63091817
Febrile neutropenia 29.23 10.01 99 104746 118350 63265827
Prescribed overdose 29.11 10.01 10 104835 34143 63350034
Distal intestinal obstruction syndrome 28.83 10.01 14 104831 404 63383773
Gastrooesophageal reflux disease 28.60 10.01 262 104583 95377 63288800
Hypertension 28.57 10.01 309 104536 278994 63105183
Sputum increased 28.21 10.01 27 104818 2432 63381745
Influenza 28.17 10.01 289 104556 108433 63275744
Abdominal pain 28.01 10.01 658 104187 292798 63091379
Pneumothorax 27.88 10.01 74 104771 16187 63367990
Agranulocytosis 27.72 10.01 98 104747 25036 63359141
Platelet count decreased 27.35 10.01 99 104746 116023 63268154
Sedation 27.32 10.01 15 104830 38794 63345383
Osteoarthritis 26.86 10.01 75 104770 95268 63288909
Pelvic inflammatory disease 26.54 10.01 22 104823 1640 63382537
Female genital tract fistula 26.49 10.01 46 104799 7513 63376664
Gait inability 26.46 10.01 29 104816 52930 63331247
Ill-defined disorder 26.38 10.01 60 104785 81695 63302482
Gait disturbance 26.11 10.01 186 104659 182992 63201185
Vaginal discharge 25.97 10.01 51 104794 9147 63375030
Proctitis 25.79 10.01 38 104807 5403 63378774
COVID-19 pneumonia 25.73 10.01 66 104779 14143 63370034
General physical health deterioration 25.65 10.01 211 104634 201191 63182986
Suicide attempt 25.62 10.01 38 104807 60880 63323297
Dysphonia 25.54 10.01 150 104695 47464 63336713
Lung transplant rejection 25.46 10.01 17 104828 910 63383267
Increased bronchial secretion 25.37 10.01 22 104823 1744 63382433
Mixed liver injury 25.28 10.01 35 104810 4700 63379477
Gallbladder injury 25.18 10.01 20 104825 1403 63382774
Gastroenteritis staphylococcal 24.96 10.01 8 104837 72 63384105
Neutrophil count decreased 24.90 10.01 34 104811 56372 63327805
Pain 24.89 10.01 986 103859 739642 62644535
Factor V deficiency 24.77 10.01 8 104837 74 63384103
Adverse drug reaction 24.52 10.01 60 104785 79654 63304523
Deep vein thrombosis 24.26 10.01 228 104617 83572 63300605
Mechanical urticaria 24.26 10.01 13 104832 463 63383714
Anhedonia 24.19 10.01 55 104790 10919 63373258
Hypomania 24.14 10.01 40 104805 6290 63377887
Anxiety 23.98 10.01 498 104347 217043 63167134
Neutropenia 23.83 10.01 180 104665 174825 63209352
Sinusitis 23.74 10.01 515 104330 226138 63158039
Eye pruritus 23.41 10.01 76 104769 18595 63365582
Hypotension 23.15 10.01 314 104531 272290 63111887
Prescribed underdose 23.14 10.01 10 104835 29679 63354498
Adverse event 23.10 10.01 48 104797 67511 63316666
Ageusia 23.06 10.01 62 104783 13666 63370511
Amniotic cavity infection 22.88 10.01 18 104827 1245 63382932
Gallbladder cholesterolosis 22.66 10.01 15 104830 791 63383386
Pain in extremity 22.66 10.01 398 104447 331088 63053089
Staphylococcus test positive 22.63 10.01 30 104815 3866 63380311
Granulomatosis with polyangiitis 22.52 10.01 23 104822 2242 63381935
Gastrointestinal disorder 22.43 10.01 126 104719 131113 63253064
Appetite disorder 22.40 10.01 42 104803 7279 63376898
Pneumonia pseudomonal 22.11 10.01 24 104821 2509 63381668
Therapeutic product effect incomplete 22.08 10.01 309 104536 124747 63259430
Sinus congestion 22.03 10.01 73 104772 18050 63366127
Rhinocerebral mucormycosis 21.76 10.01 12 104833 453 63383724
Endometritis 21.73 10.01 16 104829 1002 63383175
Pregnancy 21.70 10.01 119 104726 36717 63347460
Therapeutic response decreased 21.64 10.01 43 104802 61482 63322695
Cystic fibrosis lung 21.53 10.01 8 104837 116 63384061
Thermal burn 21.45 10.01 37 104808 6009 63378168
Cognitive disorder 21.42 10.01 37 104808 55778 63328399
Orthostatic hypotension 21.37 10.01 17 104828 36143 63348034
Mycobacterial infection 21.26 10.01 20 104825 1763 63382414
Choroiditis 21.16 10.01 9 104836 189 63383988
Mucosal inflammation 21.00 10.01 28 104817 46900 63337277
Coma 20.95 10.01 47 104798 64317 63319860
Stenotrophomonas infection 20.91 10.01 21 104824 2006 63382171
Injection site erythema 20.87 10.01 69 104776 83105 63301072
Contusion 20.58 10.01 154 104691 149890 63234287
Breast cancer 20.52 10.01 30 104815 48353 63335824
Aphthous ulcer 20.51 10.01 60 104785 13878 63370299
Hypokalaemia 20.38 10.01 95 104750 103709 63280468
Staphylococcal infection 20.24 10.01 127 104718 41129 63343048
Delusional disorder, persecutory type 20.17 10.01 9 104836 213 63383964
Uterine perforation 20.13 10.01 39 104806 6924 63377253
Sneezing 20.06 10.01 71 104774 18147 63366030
Eosinophilic pneumonia acute 19.95 10.01 11 104834 415 63383762
Paranasal sinus discomfort 19.93 10.01 30 104815 4346 63379831
Cystic fibrosis related diabetes 19.92 10.01 6 104839 43 63384134
Injection site bruising 19.80 10.01 24 104821 41886 63342291
Bronchomalacia 19.79 10.01 9 104836 223 63383954
Pancreatic failure 19.71 10.01 15 104830 988 63383189
Aspergillus infection 19.46 10.01 42 104803 8051 63376126
Injection site pain 19.37 10.01 130 104715 129670 63254507
Pneumonia bacterial 19.29 10.01 46 104799 9419 63374758
Gastrointestinal haemorrhage 19.25 10.01 69 104776 81107 63303070
Respiratory tract congestion 19.21 10.01 69 104776 17763 63366414
Palmar-plantar erythrodysaesthesia syndrome 19.17 10.01 7 104838 23008 63361169
Pyrexia 19.16 10.01 955 103890 469523 62914654
Sinus polyp degeneration 19.13 10.01 6 104839 50 63384127
Drug tolerance decreased 19.07 10.01 3 104842 17470 63366707
Emphysema 18.98 10.01 50 104795 10888 63373289
Viral infection 18.90 10.01 112 104733 35551 63348626
Pulmonary infarction 18.88 10.01 23 104822 2724 63381453
Hyponatraemia 18.81 10.01 108 104737 111792 63272385
Immune reconstitution inflammatory syndrome 18.73 10.01 35 104810 6049 63378128
Intentional product use issue 18.64 10.01 129 104716 127763 63256414
Hypoaesthesia 18.55 10.01 183 104662 168210 63215967
Depressive symptom 18.51 10.01 28 104817 4074 63380103
Atypical mycobacterial infection 18.48 10.01 15 104830 1085 63383092
Disease progression 18.30 10.01 123 104722 122635 63261542
Actinic keratosis 18.21 10.01 22 104823 2582 63381595
Weight increased 18.17 10.01 312 104533 260480 63123697
Muscular weakness 18.03 10.01 123 104722 122230 63261947
Hypertransaminasaemia 17.88 10.01 36 104809 6573 63377604
Cardiac arrest 17.70 10.01 232 104613 92313 63291864
Vaginal stricture 17.60 10.01 4 104841 7 63384170
White blood cell count decreased 17.58 10.01 146 104699 138958 63245219
Myasthenia gravis 17.54 10.01 29 104816 4552 63379625
Ventricular tachycardia 17.19 10.01 72 104773 19907 63364270
Multiple allergies 17.14 10.01 56 104789 13746 63370431
Sinus disorder 17.02 10.01 83 104762 24470 63359707
Hospitalisation 16.99 10.01 215 104630 84866 63299311
Injection site swelling 16.95 10.01 33 104812 47539 63336638
Obliterative bronchiolitis 16.82 10.01 19 104826 2076 63382101
Biliary colic 16.77 10.01 25 104820 3592 63380585
Laryngeal mass 16.70 10.01 5 104840 35 63384142
Foetal exposure during pregnancy 16.69 10.01 100 104745 31862 63352315
Drug effective for unapproved indication 16.68 10.01 24 104821 3340 63380837
Hepatocellular injury 16.49 10.01 89 104756 27292 63356885
Hypercapnia 16.42 10.01 31 104814 5400 63378777
Arthritis 16.36 10.01 118 104727 115803 63268374
Mucocutaneous candidiasis 16.36 10.01 4 104841 11 63384166
Lung disorder 16.36 10.01 166 104679 62095 63322082
Pigment nephropathy 16.34 10.01 5 104840 38 63384139
Portal hypertensive enteropathy 16.22 10.01 3 104842 0 63384177
Bronchogram abnormal 16.22 10.01 3 104842 0 63384177
Stillbirth 16.20 10.01 35 104810 6715 63377462
Balance disorder 16.13 10.01 78 104767 84344 63299833
Lacrimation increased 15.95 10.01 72 104773 20559 63363618
Autoimmune hepatitis 15.90 10.01 40 104805 8470 63375707
Meningism 15.86 10.01 10 104835 485 63383692
Paranasal sinus inflammation 15.86 10.01 10 104835 485 63383692
Vaginal cellulitis 15.78 10.01 6 104839 93 63384084
Hypofibrinogenaemia 15.66 10.01 14 104831 1156 63383021
C-reactive protein increased 15.60 10.01 92 104753 94615 63289562
Hemianopia heteronymous 15.60 10.01 5 104840 45 63384132
Radiculopathy 15.59 10.01 40 104805 8571 63375606
Mycoplasma infection 15.51 10.01 10 104835 504 63383673
Iris transillumination defect 15.49 10.01 6 104839 98 63384079
Peak expiratory flow rate abnormal 15.44 10.01 6 104839 99 63384078
Infusion site streaking 15.32 10.01 10 104835 515 63383662
Leukaemoid reaction 15.30 10.01 7 104838 176 63384001
Depressed level of consciousness 15.23 10.01 52 104793 62026 63322151
Chest pain 15.07 10.01 465 104380 215494 63168683
Deafness neurosensory 15.04 10.01 28 104817 4827 63379350
Dehydration 14.95 10.01 199 104646 173155 63211022
Hypoxic-ischaemic encephalopathy 14.90 10.01 26 104819 4261 63379916
Local reaction 14.81 10.01 11 104834 698 63383479
Lung neoplasm malignant 14.79 10.01 68 104777 19565 63364612
Pharyngeal enanthema 14.79 10.01 5 104840 54 63384123
Eosinophilic pneumonia chronic 14.77 10.01 7 104838 191 63383986
Altered state of consciousness 14.73 10.01 12 104833 25218 63358959
HIV infection 14.70 10.01 9 104836 414 63383763
Frequent bowel movements 14.67 10.01 76 104769 22946 63361231
Seasonal allergy 14.65 10.01 71 104774 20879 63363298
Neural tube defect 14.64 10.01 7 104838 195 63383982
Tachypnoea 14.61 10.01 62 104783 17240 63366937
Sputum purulent 14.54 10.01 13 104832 1074 63383103
Muscle spasticity 14.52 10.01 9 104836 21785 63362392
Cardiac failure 14.47 10.01 87 104758 89055 63295122
Vasculitis 14.42 10.01 64 104781 18145 63366032
Diabetic ketoacidosis 14.32 10.01 8 104837 20497 63363680
Foot deformity 14.19 10.01 15 104830 27838 63356339
Post polio syndrome 14.18 10.01 4 104841 22 63384155
Neoplasm progression 14.11 10.01 24 104821 36404 63347773
Sputum retention 14.08 10.01 10 104835 592 63383585
Bronchial secretion retention 14.06 10.01 20 104825 2753 63381424
Respiratory tract inflammation 14.05 10.01 10 104835 594 63383583
Rebound acid hypersecretion 14.04 10.01 8 104837 322 63383855
Catastrophic reaction 14.03 10.01 4 104841 23 63384154
Procedural anxiety 13.93 10.01 11 104834 765 63383412
Crystal arthropathy 13.90 10.01 8 104837 328 63383849
Lymph node abscess 13.89 10.01 4 104841 24 63384153
Dysentery 13.86 10.01 12 104833 949 63383228
Acute respiratory failure 13.83 10.01 101 104744 34384 63349793
Rheumatoid factor 13.77 10.01 8 104837 334 63383843
Injection site warmth 13.75 10.01 4 104841 15191 63368986
Rhinalgia 13.70 10.01 15 104830 1584 63382593
Intentional product misuse 13.64 10.01 53 104792 60864 63323313
Sopor 13.63 10.01 10 104835 22154 63362023
Respiratory tract infection fungal 13.59 10.01 9 104836 475 63383702
Sleep disorder 13.56 10.01 79 104766 81487 63302690
Hepatitis cholestatic 13.56 10.01 33 104812 6845 63377332
Cholestasis 13.45 10.01 89 104756 29345 63354832
Aspiration 13.45 10.01 44 104801 10807 63373370
Immunodeficiency common variable 13.44 10.01 7 104838 235 63383942
Humidity intolerance 13.35 10.01 8 104837 354 63383823
Erythema multiforme 13.30 10.01 42 104803 10127 63374050
Hypersensitivity pneumonitis 13.27 10.01 19 104826 2631 63381546
Deafness bilateral 13.18 10.01 14 104831 1428 63382749
Pneumonia aspiration 13.16 10.01 23 104822 34517 63349660
Rash maculo-papular 13.13 10.01 94 104751 31802 63352375
Bronchial anastomosis complication 13.12 10.01 4 104841 30 63384147
Injection site reaction 13.06 10.01 51 104794 58473 63325704
Disease risk factor 13.01 10.01 5 104840 80 63384097
Epidermolysis 13.00 10.01 10 104835 669 63383508
Monoclonal gammopathy 13.00 10.01 10 104835 669 63383508
Anal skin tags 12.96 10.01 9 104836 514 63383663
Kawasaki's disease 12.94 10.01 3 104842 6 63384171
Joint effusion 12.90 10.01 6 104839 17054 63367123
Metastases to liver 12.89 10.01 12 104833 23627 63360550
Meningoencephalitis bacterial 12.84 10.01 5 104840 83 63384094
Lung diffusion test decreased 12.76 10.01 10 104835 688 63383489
Cerebral venous sinus thrombosis 12.73 10.01 16 104829 1956 63382221
Veillonella infection 12.68 10.01 4 104841 34 63384143
Bronchial obstruction 12.67 10.01 14 104831 1493 63382684
Forced vital capacity decreased 12.67 10.01 12 104833 1067 63383110
Rhinovirus infection 12.65 10.01 25 104820 4504 63379673
Tympanic membrane hyperaemia 12.62 10.01 3 104842 7 63384170
Oesophagogastroduodenoscopy 12.62 10.01 6 104839 165 63384012
Brain hypoxia 12.61 10.01 9 104836 537 63383640
Corneal perforation 12.58 10.01 9 104836 539 63383638
Urethral stenosis 12.58 10.01 7 104838 269 63383908
Ear discomfort 12.57 10.01 35 104810 7871 63376306
Immunosuppressant drug level increased 12.57 10.01 22 104823 3616 63380561
Grip strength decreased 12.52 10.01 11 104834 22276 63361901
Urinary tract infection 12.50 10.01 337 104508 264347 63119830
Dysarthria 12.47 10.01 33 104812 42678 63341499
Increased upper airway secretion 12.42 10.01 22 104823 3650 63380527
Multiple sclerosis relapse 12.31 10.01 40 104805 48438 63335739
Respiratory distress 12.25 10.01 97 104748 33854 63350323
Asthmatic crisis 12.17 10.01 15 104830 1798 63382379
Gallbladder hypofunction 12.15 10.01 9 104836 569 63383608
Respiratory syncytial virus infection 12.09 10.01 32 104813 6986 63377191
Vulvovaginal candidiasis 12.02 10.01 20 104825 3155 63381022
Dermatosis 12.01 10.01 7 104838 294 63383883
Photodermatosis 12 10.01 8 104837 427 63383750
Osteonecrosis of jaw 11.97 10.01 25 104820 35098 63349079
Creatinine renal clearance decreased 11.92 10.01 6 104839 16302 63367875
Vulvovaginal burning sensation 11.88 10.01 16 104829 2093 63382084
Hepatotoxicity 11.85 10.01 103 104742 36938 63347239
Vascular access site pain 11.85 10.01 5 104840 103 63384074
Hypoventilation 11.81 10.01 25 104820 4729 63379448
Vaginal abscess 11.67 10.01 8 104837 447 63383730
Underdose 11.67 10.01 17 104828 27439 63356738
Pneumonia necrotising 11.64 10.01 8 104837 449 63383728
Eye irritation 11.64 10.01 69 104776 21902 63362275
Hypoacusis 11.63 10.01 74 104771 24077 63360100
Biopsy colon abnormal 11.59 10.01 5 104840 109 63384068
Lung infiltration 11.58 10.01 51 104794 14412 63369765
Intestinal anastomosis 11.55 10.01 8 104837 455 63383722
BK virus infection 11.55 10.01 20 104825 3259 63380918
Breast cancer female 11.50 10.01 4 104841 13555 63370622
Neisseria infection 11.50 10.01 5 104840 111 63384066
Hepato-lenticular degeneration 11.42 10.01 3 104842 12 63384165
Hilar lymphadenopathy 11.41 10.01 12 104833 1210 63382967
Acute disseminated encephalomyelitis 11.40 10.01 6 104839 206 63383971
Ruptured ectopic pregnancy 11.35 10.01 8 104837 468 63383709
Lower limb fracture 11.31 10.01 14 104831 24207 63359970
Atypical mycobacterial lower respiratory tract infection 11.30 10.01 5 104840 116 63384061
Epilepsy 11.27 10.01 17 104828 27048 63357129
COVID-19 treatment 11.26 10.01 5 104840 117 63384060
Oesophageal injury 11.23 10.01 4 104841 51 63384126
Blood pressure fluctuation 11.23 10.01 39 104806 46278 63337899
Ecchymosis 11.17 10.01 42 104803 11052 63373125
Nosocomial infection 11.17 10.01 14 104831 1707 63382470
Developmental delay 11.15 10.01 13 104832 1470 63382707
Stomatococcal infection 11.14 10.01 5 104840 120 63384057
Schizophrenia 11.14 10.01 39 104806 9913 63374264
Product colour issue 11.13 10.01 9 104836 648 63383529
Pneumopericardium 11.09 10.01 4 104841 53 63384124
Metastases to bone 11.07 10.01 11 104834 21008 63363169
Abscess bacterial 11.04 10.01 6 104839 220 63383957
Central nervous system fungal infection 10.96 10.01 5 104840 125 63384052
Vascular parkinsonism 10.88 10.01 5 104840 127 63384050
Otitis media fungal 10.87 10.01 3 104842 15 63384162
Bacterial infection 10.82 10.01 62 104783 19437 63364740
Loss of consciousness 10.77 10.01 134 104711 117987 63266190
Ureteric perforation 10.71 10.01 3 104842 16 63384161
Cranial nerve paralysis 10.70 10.01 5 104840 132 63384045
Immune reconstitution inflammatory syndrome associated tuberculosis 10.68 10.01 7 104838 363 63383814
Illness 10.67 10.01 126 104719 48933 63335244
HIV-associated neurocognitive disorder 10.67 10.01 5 104840 133 63384044
Cholecystitis 10.67 10.01 52 104793 15325 63368852
Liver disorder 10.61 10.01 49 104796 53638 63330539
Anal inflammation 10.59 10.01 6 104839 239 63383938
Bacterial disease carrier 10.57 10.01 12 104833 1319 63382858
Inflammation 10.55 10.01 86 104759 82187 63301990
Infusion site bruising 10.52 10.01 21 104824 3811 63380366
Normal newborn 10.50 10.01 34 104811 8307 63375870
Angina bullosa haemorrhagica 10.47 10.01 5 104840 139 63384038
Vulvovaginal pruritus 10.42 10.01 19 104826 3224 63380953
Injection site haemorrhage 10.39 10.01 15 104830 24299 63359878
Basal cell carcinoma 10.34 10.01 19 104826 27972 63356205
Acute sinusitis 10.31 10.01 21 104824 3866 63380311
SJS-TEN overlap 10.30 10.01 7 104838 386 63383791
Dyspepsia 10.30 10.01 231 104614 101965 63282212
Pneumonitis 10.27 10.01 96 104749 35126 63349051
Metabolic acidosis 10.23 10.01 39 104806 45030 63339147
Scedosporium infection 10.15 10.01 8 104837 555 63383622
Nasal dryness 10.14 10.01 23 104822 4558 63379619
Acute kidney injury 10.14 10.01 532 104313 262883 63121294
Pulmonary mass 10.13 10.01 68 104777 22528 63361649
ECG signs of myocardial ischaemia 10.08 10.01 4 104841 70 63384107
End stage renal disease 10.03 10.01 29 104816 6664 63377513
Atypical mycobacterial pneumonia 10.02 10.01 3 104842 21 63384156

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 1900.27 10.59 3160 67005 416364 34470402
Infective pulmonary exacerbation of cystic fibrosis 613.52 10.59 291 69874 6510 34880256
Electrocardiogram QT prolonged 436.27 10.59 472 69693 40480 34846286
Asthma 299.86 10.59 398 69767 42258 34844508
Drug ineffective for unapproved indication 276.65 10.59 287 69878 23428 34863338
Drug hypersensitivity 199.37 10.59 475 69690 80054 34806712
Product use in unapproved indication 198.93 10.59 602 69563 116897 34769869
Wheezing 154.60 10.59 289 69876 41113 34845653
Long QT syndrome 154.19 10.59 86 70079 2717 34884049
Immune reconstitution inflammatory syndrome 151.79 10.59 132 70033 8627 34878139
Drug abuse 150.69 10.59 13 70152 99083 34787683
Obstructive airways disorder 144.93 10.59 167 69998 15327 34871439
Bronchiectasis 142.86 10.59 134 70031 9667 34877099
Drug interaction 140.53 10.59 853 69312 225093 34661673
No adverse event 128.43 10.59 192 69973 22735 34864031
Cystic fibrosis 125.62 10.59 63 70102 1595 34885171
Hypertransaminasaemia 125.42 10.59 98 70067 5508 34881258
Productive cough 122.94 10.59 249 69916 37564 34849202
Hepatitis 122.38 10.59 192 69973 23712 34863054
Drug effective for unapproved indication 116.94 10.59 70 70095 2532 34884234
Completed suicide 116.58 10.59 27 70138 98141 34788625
Breath sounds abnormal 111.83 10.59 100 70065 6781 34879985
Cough 110.37 10.59 593 69572 149547 34737219
Haemoptysis 108.47 10.59 226 69939 34780 34851986
Fall 105.90 10.59 152 70013 202733 34684033
Condition aggravated 99.99 10.59 694 69471 191502 34695264
Death 94.43 10.59 445 69720 397604 34489162
Congenital hiatus hernia 91.35 10.59 41 70124 803 34885963
Pulmonary function test decreased 88.27 10.59 76 70089 4899 34881867
Malignant neoplasm progression 83.59 10.59 36 70129 88010 34798756
Sleep disorder due to a general medical condition 83.11 10.59 75 70090 5146 34881620
Stevens-Johnson syndrome 78.31 10.59 137 70028 18502 34868264
Forced expiratory volume decreased 78.24 10.59 59 70106 3144 34883622
Dysplastic naevus 76.59 10.59 31 70134 465 34886301
Product packaging quantity issue 75.42 10.59 37 70128 892 34885874
Vanishing bile duct syndrome 75.13 10.59 38 70127 980 34885786
Toxicity to various agents 73.85 10.59 185 69980 200177 34686589
Solar lentigo 73.55 10.59 31 70134 518 34886248
Photodermatosis 72.80 10.59 31 70134 532 34886234
Eosinophil count abnormal 71.35 10.59 26 70139 288 34886478
Full blood count abnormal 65.55 10.59 127 70038 18541 34868225
Ototoxicity 64.65 10.59 43 70122 1874 34884892
Febrile neutropenia 63.30 10.59 111 70054 136738 34750028
Drug resistance 59.85 10.59 149 70016 25778 34860988
Torsade de pointes 59.64 10.59 73 70092 7136 34879630
Respiratory disorder 58.05 10.59 123 70042 19141 34867625
Somnolence 55.21 10.59 86 70079 111030 34775736
Toxic epidermal necrolysis 54.89 10.59 129 70036 21517 34865249
Mycobacterium avium complex infection 54.23 10.59 43 70122 2468 34884298
Acute respiratory distress syndrome 53.50 10.59 143 70022 25826 34860940
Sinusitis 51.14 10.59 191 69974 41211 34845555
General physical health deterioration 50.74 10.59 114 70051 128155 34758611
Sputum increased 49.94 10.59 40 70125 2330 34884436
Mucocutaneous disorder 49.88 10.59 16 70149 116 34886650
Pathogen resistance 49.68 10.59 77 70088 9405 34877361
Myocardial infarction 49.22 10.59 106 70059 120979 34765787
Pneumonia 48.32 10.59 1007 69158 361620 34525146
Lung diffusion disorder 48.19 10.59 16 70149 131 34886635
Chronic obstructive pulmonary disease 47.93 10.59 210 69955 48708 34838058
Dyspnoea 47.21 10.59 1037 69128 375745 34511021
Parathyroid gland enlargement 47.16 10.59 16 70149 141 34886625
Upper respiratory fungal infection 45.63 10.59 16 70149 157 34886609
Prostate cancer 44.91 10.59 12 70153 39637 34847129
Dehydration 44.78 10.59 124 70041 129845 34756921
Hepatitis acute 44.48 10.59 65 70100 7536 34879230
Bronchopulmonary aspergillosis 43.48 10.59 93 70072 14566 34872200
Transaminases increased 42.99 10.59 135 70030 26688 34860078
Respiratory failure 42.89 10.59 368 69797 108204 34778562
Tachyarrhythmia 42.64 10.59 44 70121 3564 34883202
Malignant melanoma in situ 42.58 10.59 32 70133 1696 34885070
Fatigue 41.79 10.59 510 69655 370143 34516623
Alanine aminotransferase increased 41.40 10.59 291 69874 80524 34806242
Dizziness 41.32 10.59 263 69902 218258 34668508
Coma 41.27 10.59 20 70145 45658 34841108
Mucormycosis 41.01 10.59 55 70110 5887 34880879
Sputum discoloured 40.31 10.59 63 70102 7749 34879017
Cystic fibrosis respiratory infection suppression 40.21 10.59 16 70149 229 34886537
Drug ineffective 40.14 10.59 1199 68966 455552 34431214
Intentional overdose 39.64 10.59 19 70146 43655 34843111
Pseudomonas infection 39.58 10.59 81 70084 12301 34874465
Acute respiratory failure 39.29 10.59 144 70021 30784 34855982
Bronchiolitis obliterans syndrome 39.28 10.59 15 70150 191 34886575
Bronchial hyperreactivity 38.49 10.59 30 70135 1679 34885087
Forced expiratory volume 38.47 10.59 13 70152 113 34886653
Bronchitis 37.99 10.59 176 69989 41787 34844979
Constipation 37.94 10.59 144 70021 136838 34749928
Stenotrophomonas infection 36.96 10.59 32 70133 2078 34884688
Asthma-chronic obstructive pulmonary disease overlap syndrome 36.62 10.59 26 70139 1261 34885505
Confusional state 35.28 10.59 159 70006 144001 34742765
Fungal disease carrier 33.98 10.59 15 70150 282 34886484
Decreased appetite 33.66 10.59 196 69969 166196 34720570
Cystic fibrosis related diabetes 33.53 10.59 13 70152 173 34886593
Cryptococcal meningoencephalitis 33.42 10.59 12 70153 127 34886639
Eosinophilia 32.39 10.59 121 70044 26101 34860665
HIV associated nephropathy 32.33 10.59 15 70150 318 34886448
Lung transplant rejection 32.24 10.59 20 70145 772 34885994
Lung transplant 32.07 10.59 29 70136 1995 34884771
Pain 32.04 10.59 260 69905 204415 34682351
Scleroderma 31.99 10.59 26 70139 1546 34885220
Mycobacterial infection 31.82 10.59 31 70134 2343 34884423
COVID-19 treatment 31.67 10.59 14 70151 264 34886502
Hypertriglyceridaemia 31.54 10.59 59 70106 8389 34878377
Neutropenia 31.53 10.59 185 69980 156593 34730173
Obliterative bronchiolitis 30.42 10.59 23 70142 1230 34885536
Aspergillus infection 29.95 10.59 72 70093 12182 34874584
Lung hyperinflation 29.90 10.59 20 70145 880 34885886
Rheumatoid arthritis 29.88 10.59 20 70145 38218 34848548
Pulmonary function test abnormal 29.36 10.59 31 70134 2579 34884187
HIV infection 29.07 10.59 23 70142 1316 34885450
Myoclonic dystonia 28.71 10.59 9 70156 60 34886706
Urinary tract infection 28.36 10.59 81 70084 84000 34802766
Hepatocellular injury 27.86 10.59 103 70062 22108 34864658
Loss of personal independence in daily activities 27.74 10.59 136 70029 33043 34853723
Overdose 27.68 10.59 92 70073 90967 34795799
Asthenia 27.36 10.59 338 69827 244913 34641853
Gastrointestinal haemorrhage 27.16 10.59 89 70076 88388 34798378
Respiratory symptom 27.01 10.59 25 70140 1772 34884994
Graft versus host disease in lung 26.99 10.59 16 70149 568 34886198
Bronchopulmonary aspergillosis allergic 26.97 10.59 19 70146 910 34885856
Deafness neurosensory 26.93 10.59 31 70134 2840 34883926
Herpes simplex viraemia 26.86 10.59 9 70156 76 34886690
COVID-19 pneumonia 26.82 10.59 85 70080 16882 34869884
Jarisch-Herxheimer reaction 26.82 10.59 16 70149 575 34886191
Liver injury 26.77 10.59 78 70087 14800 34871966
Product quality issue 26.62 10.59 85 70080 16950 34869816
Cytokine storm 26.57 10.59 17 70148 693 34886073
Blood immunoglobulin E increased 26.46 10.59 29 70136 2517 34884249
Atypical mycobacterium test positive 26.35 10.59 7 70158 23 34886743
Bronchial disorder 26.04 10.59 22 70143 1381 34885385
Cryptococcosis 25.92 10.59 28 70137 2391 34884375
Distal intestinal obstruction syndrome 25.43 10.59 13 70152 343 34886423
Rash maculovesicular 25.28 10.59 7 70158 28 34886738
Cardiac failure 25.19 10.59 96 70069 91152 34795614
Ascites 25.12 10.59 34 70131 46537 34840229
Lip erythema 24.94 10.59 8 70157 58 34886708
Suicide attempt 24.92 10.59 25 70140 39091 34847675
Total lung capacity abnormal 24.77 10.59 10 70155 149 34886617
Anaemia 24.74 10.59 325 69840 233010 34653756
Blood pressure fluctuation 24.46 10.59 10 70155 25239 34861527
Mycobacterium chelonae infection 24.44 10.59 17 70148 798 34885968
Seizure 24.25 10.59 118 70047 104739 34782027
Oropharyngeal candidiasis 24.21 10.59 17 70148 810 34885956
Disease progression 24.20 10.59 123 70042 107954 34778812
Deafness 24.18 10.59 63 70102 11202 34875564
Wrong technique in product usage process 24.09 10.59 22 70143 35964 34850802
Inguinal hernia repair 23.81 10.59 12 70153 307 34886459
Actinic keratosis 23.80 10.59 37 70128 4530 34882236
Oedema peripheral 23.74 10.59 142 70023 119670 34767096
Injection site pain 23.65 10.59 26 70139 38979 34847787
Micturition urgency 23.65 10.59 45 70120 6480 34880286
Pain in extremity 23.49 10.59 153 70012 126360 34760406
NPM1 gene mutation 23.40 10.59 9 70156 117 34886649
Lung disorder 23.37 10.59 134 70031 34562 34852204
Upper-airway cough syndrome 23.14 10.59 32 70133 3526 34883240
Atypical mycobacterial infection 23.04 10.59 17 70148 876 34885890
Urethritis mycoplasmal 23.00 10.59 6 70159 18 34886748
Nasal mucosal disorder 22.99 10.59 9 70156 123 34886643
Hypercapnia 22.91 10.59 35 70130 4220 34882546
Haemolytic anaemia 22.90 10.59 59 70106 10420 34876346
Conjunctival hyperaemia 22.64 10.59 26 70139 2376 34884390
Bladder cancer 22.52 10.59 3 70162 16275 34870491
Therapeutic product effect decreased 22.37 10.59 22 70143 34721 34852045
Blood pressure increased 22.24 10.59 96 70069 88006 34798760
Disseminated cryptococcosis 22.24 10.59 20 70145 1366 34885400
Premature baby 22.12 10.59 88 70077 19545 34867221
Hepatitis cholestatic 21.95 10.59 49 70116 7898 34878868
Cerebral infarction 21.94 10.59 14 70151 27441 34859325
Pharyngeal erythema 21.81 10.59 15 70150 691 34886075
Cerebrovascular accident 21.66 10.59 92 70073 84719 34802047
Contraindicated product administered 21.65 10.59 8 70157 21473 34865293
Pulmonary vasculitis 21.57 10.59 14 70151 585 34886181
Hepatic necrosis 21.56 10.59 32 70133 3762 34883004
Viral infection 21.50 10.59 81 70084 17542 34869224
Arthralgia 21.41 10.59 228 69937 169813 34716953
Rubber sensitivity 21.14 10.59 10 70155 222 34886544
Platelet count decreased 21.12 10.59 147 70018 119570 34767196
Influenza 21.00 10.59 171 69994 49495 34837271
Jaw cyst 20.93 10.59 6 70159 28 34886738
Acquired immunodeficiency syndrome 20.88 10.59 13 70152 505 34886261
Hypoxia 20.82 10.59 185 69980 54910 34831856
Infective chondritis 20.59 10.59 5 70160 10 34886756
Rash morbilliform 20.43 10.59 28 70137 3059 34883707
Pneumonia mycoplasmal 20.34 10.59 14 70151 646 34886120
Bacterial pericarditis 20.31 10.59 7 70158 65 34886701
Iris adhesions 20.27 10.59 10 70155 244 34886522
Pneumothorax 20.26 10.59 84 70081 19008 34867758
Gastrooesophageal reflux disease 20.25 10.59 138 70027 37786 34848980
Carbon dioxide increased 20.17 10.59 17 70148 1064 34885702
Methaemoglobinaemia 20.06 10.59 30 70135 3551 34883215
Cognitive disorder 19.86 10.59 17 70148 28676 34858090
Gonorrhoea 19.76 10.59 7 70158 71 34886695
Impaired quality of life 19.71 10.59 39 70126 5779 34880987
Chest discomfort 19.53 10.59 181 69984 54349 34832417
Linear IgA disease 19.52 10.59 20 70145 1606 34885160
Liver function test increased 19.50 10.59 69 70096 14496 34872270
Enterovirus infection 19.42 10.59 16 70149 970 34885796
Pulmonary alveolar haemorrhage 19.29 10.59 45 70120 7467 34879299
Wrong dose 19.15 10.59 13 70152 586 34886180
Malabsorption from administration site 19.01 10.59 7 70158 80 34886686
Respiratory syncytial virus infection 18.98 10.59 34 70131 4675 34882091
Cholestasis 18.76 10.59 105 70060 26843 34859923
Mediastinal shift 18.62 10.59 4 70161 3 34886763
Myasthenia gravis crisis 18.62 10.59 13 70152 614 34886152
Cardiac failure congestive 18.51 10.59 95 70070 83175 34803591
Dyspnoea exertional 18.29 10.59 149 70016 43130 34843636
Contusion 18.18 10.59 28 70137 36336 34850430
Rash 18.17 10.59 580 69585 222172 34664594
Nervous system neoplasm 18.14 10.59 8 70157 150 34886616
Andersen-Tawil syndrome 18.09 10.59 4 70161 4 34886762
Antinuclear antibody negative 18.06 10.59 5 70160 20 34886746
Pneumomediastinum 18.03 10.59 23 70142 2344 34884422
Back pain 17.99 10.59 157 70008 121632 34765134
Liver function test 17.87 10.59 6 70159 51 34886715
Acute generalised exanthematous pustulosis 17.85 10.59 41 70124 6735 34880031
Vestibular disorder 17.81 10.59 16 70149 1091 34885675
Interstitial lung disease 17.81 10.59 69 70096 65213 34821553
Chimerism 17.73 10.59 9 70156 234 34886532
Acoustic neuroma 17.67 10.59 8 70157 160 34886606
Drug reaction with eosinophilia and systemic symptoms 17.55 10.59 120 70045 32892 34853874
Alcohol intolerance 17.49 10.59 11 70154 435 34886331
Osteonecrosis of jaw 17.47 10.59 7 70158 17882 34868884
Myopia 17.46 10.59 16 70149 1120 34885646
Restrictive allograft syndrome 17.32 10.59 5 70160 24 34886742
Therapeutic product effect incomplete 17.23 10.59 166 69999 50375 34836391
Cystic fibrosis lung 17.19 10.59 6 70159 58 34886708
Hypofibrinogenaemia 17.17 10.59 19 70146 1667 34885099
Lung infiltration 17.16 10.59 61 70104 12844 34873922
Sputum retention 17.14 10.59 11 70154 451 34886315
Immunodeficiency common variable 17.10 10.59 8 70157 173 34886593
Rash maculo-papular 16.69 10.59 106 70059 28345 34858421
End stage renal disease 16.46 10.59 47 70118 8814 34877952
Haemoglobin decreased 16.41 10.59 159 70006 120613 34766153
Hypotension 16.40 10.59 330 69835 221319 34665447
Hyponatraemia 16.38 10.59 98 70067 82593 34804173
Upper respiratory tract infection 16.30 10.59 118 70047 32941 34853825
Lip oedema 16.25 10.59 23 70142 2590 34884176
Urinary retention 16.24 10.59 30 70135 36258 34850508
Glucose-6-phosphate dehydrogenase deficiency 16.08 10.59 7 70158 127 34886639
Neuritis 16.02 10.59 14 70151 920 34885846
Enterobacter infection 16.02 10.59 22 70143 2408 34884358
Lymph node palpable 15.86 10.59 5 70160 34 34886732
Mastocytosis 15.86 10.59 5 70160 34 34886732
Secretion discharge 15.85 10.59 36 70129 5869 34880897
Pancreatic failure 15.82 10.59 13 70152 785 34885981
Atypical mycobacterial lower respiratory tract infection 15.74 10.59 5 70160 35 34886731
Metastases to liver 15.73 10.59 4 70161 13659 34873107
Palmar-plantar erythrodysaesthesia syndrome 15.71 10.59 7 70158 16788 34869978
Haemoglobin E disease 15.64 10.59 3 70162 0 34886766
Senile pruritus 15.64 10.59 3 70162 0 34886766
Pneumonia serratia 15.64 10.59 3 70162 0 34886766
Propofol infusion syndrome 15.62 10.59 14 70151 952 34885814
Decreased activity 15.58 10.59 30 70135 4357 34882409
Oral mucosa erosion 15.54 10.59 14 70151 958 34885808
Hyperkalaemia 15.51 10.59 79 70086 69310 34817456
COVID-19 15.49 10.59 230 69935 77320 34809446
Hepatomegaly 15.45 10.59 51 70114 10345 34876421
CD4 lymphocytes increased 15.41 10.59 8 70157 218 34886548
Tooth discolouration 15.41 10.59 10 70155 418 34886348
Coinfection 15.38 10.59 5 70160 38 34886728
Dysarthria 15.35 10.59 29 70136 34753 34852013
Neutrophil count decreased 15.27 10.59 52 70113 51052 34835714
Rash erythematous 15.24 10.59 94 70071 24883 34861883
Cerebral toxoplasmosis 15.17 10.59 18 70147 1703 34885063
Pseudomembranous colitis 15.09 10.59 23 70142 2768 34883998
Chorioretinitis 14.93 10.59 10 70155 441 34886325
ADAMTS13 activity decreased 14.88 10.59 6 70159 89 34886677
Respiratory depression 14.84 10.59 7 70158 16238 34870528
Laziness 14.82 10.59 9 70156 334 34886432
Cardiogenic shock 14.79 10.59 19 70146 26599 34860167
Low birth weight baby 14.76 10.59 42 70123 7863 34878903
Deafness unilateral 14.65 10.59 19 70146 1968 34884798
Adverse event 14.57 10.59 10 70155 18867 34867899
Urinary incontinence 14.57 10.59 10 70155 18864 34867902
Bronchospasm 14.51 10.59 51 70114 10680 34876086
Memory impairment 14.40 10.59 42 70123 43276 34843490
Hypogammaglobulinaemia 14.33 10.59 41 70124 7699 34879067
Hypocapnia 14.30 10.59 7 70158 168 34886598
Drug-induced liver injury 14.27 10.59 103 70062 28729 34858037
Accidental exposure to product 14.26 10.59 4 70161 12798 34873968
Urosepsis 14.25 10.59 4 70161 12795 34873971
Clostridium difficile colitis 14.25 10.59 66 70099 15664 34871102
Hypoglycaemia 14.11 10.59 59 70106 54581 34832185
Forced vital capacity decreased 14.06 10.59 12 70153 764 34886002
Hypercholesterolaemia 13.94 10.59 44 70121 8718 34878048
Bronchopleural fistula 13.94 10.59 10 70155 493 34886273
Prostatic specific antigen increased 13.92 10.59 6 70159 14674 34872092
Aspartate aminotransferase increased 13.92 10.59 202 69963 67581 34819185
Syncope 13.90 10.59 117 70048 91334 34795432
Infusion related reaction 13.89 10.59 57 70108 53000 34833766
Neurological examination abnormal 13.81 10.59 8 70157 272 34886494
Blood glucose increased 13.78 10.59 78 70087 66640 34820126
Borderline personality disorder 13.76 10.59 9 70156 381 34886385
Folliculitis 13.57 10.59 29 70136 4537 34882229
Papillary muscle rupture 13.57 10.59 3 70162 3 34886763
Delusion of parasitosis 13.57 10.59 3 70162 3 34886763
Acute hepatic failure 13.45 10.59 60 70105 14014 34872752
Rotavirus infection 13.45 10.59 9 70156 396 34886370
Rhonchi 13.45 10.59 18 70147 1922 34884844
Mycoplasma infection 13.33 10.59 9 70156 402 34886364
Cytomegalovirus chorioretinitis 13.31 10.59 25 70140 3564 34883202
Red blood cell sedimentation rate decreased 13.29 10.59 5 70160 61 34886705
Haemorrhoids thrombosed 13.22 10.59 7 70158 199 34886567
Severe acute respiratory syndrome 13.21 10.59 5 70160 62 34886704
Brain abscess 13.16 10.59 23 70142 3102 34883664
Rheumatic fever 13.12 10.59 4 70161 24 34886742
Balance disorder 13.09 10.59 40 70125 40614 34846152
Multiple sclerosis relapse 13.05 10.59 5 70160 13128 34873638
Pleural fistula 12.98 10.59 4 70161 25 34886741
Palatal oedema 12.96 10.59 12 70153 851 34885915
Musculoskeletal stiffness 12.95 10.59 49 70116 46631 34840135
Disturbance in attention 12.94 10.59 20 70145 25925 34860841
Pneumonia pseudomonal 12.94 10.59 26 70139 3896 34882870
Nail pitting 12.94 10.59 8 70157 307 34886459
Tongue discolouration 12.91 10.59 14 70151 1201 34885565
Rhinocerebral mucormycosis 12.86 10.59 10 70155 558 34886208
Bronchomalacia 12.86 10.59 6 70159 129 34886637
SJS-TEN overlap 12.82 10.59 8 70157 312 34886454
Sedation 12.73 10.59 14 70151 20992 34865774
Therapeutic product ineffective for unapproved indication 12.73 10.59 5 70160 69 34886697
Small intestinal obstruction 12.69 10.59 7 70158 14859 34871907
Pneumonia escherichia 12.60 10.59 9 70156 441 34886325
Respiratory distress 12.58 10.59 118 70047 35547 34851219
Depressed level of consciousness 12.52 10.59 44 70121 42797 34843969
Eosinophilic pustular folliculitis 12.48 10.59 5 70160 73 34886693
Gait disturbance 12.46 10.59 110 70055 85030 34801736
Tinnitus 12.45 10.59 76 70089 20042 34866724
Superinfection bacterial 12.44 10.59 12 70153 896 34885870
Achromotrichia congenital 12.36 10.59 3 70162 6 34886760
Cutaneous extramedullary haemopoiesis 12.36 10.59 3 70162 6 34886760
Antibiotic associated colitis 12.36 10.59 3 70162 6 34886760
Pulmonary artery dilatation 12.35 10.59 7 70158 228 34886538
Presyncope 12.35 10.59 12 70153 19047 34867719
Pneumonia aspiration 12.27 10.59 43 70122 41860 34844906
Delusion 12.25 10.59 5 70160 12630 34874136
Anticoagulation drug level above therapeutic 12.24 10.59 18 70147 2098 34884668
Lip ulceration 12.15 10.59 11 70154 758 34886008
FEV1/FVC ratio abnormal 12.13 10.59 4 70161 32 34886734
Tuberculosis gastrointestinal 12.11 10.59 7 70158 237 34886529
Acute febrile neutrophilic dermatosis 12.10 10.59 14 70151 1289 34885477
Acute myocardial infarction 12.09 10.59 61 70104 53658 34833108
Prothrombin level decreased 11.99 10.59 13 70152 1115 34885651
Seborrhoea 11.98 10.59 7 70158 242 34886524
Tumour lysis syndrome 11.94 10.59 10 70155 17049 34869717
Tendon disorder 11.90 10.59 21 70144 2854 34883912
Heart rate decreased 11.90 10.59 29 70136 31716 34855050
Chlamydial infection 11.87 10.59 7 70158 246 34886520
Flushing 11.85 10.59 30 70135 32390 34854376
Muscle spasms 11.83 10.59 95 70070 74906 34811860
Optic neuropathy 11.78 10.59 17 70148 1948 34884818
Occupational exposure to air contaminants 11.75 10.59 6 70159 158 34886608
Mucosal inflammation 11.74 10.59 39 70126 38583 34848183
Viral pharyngitis 11.71 10.59 6 70159 159 34886607
Renal tubular injury 11.64 10.59 12 70153 971 34885795
Respiration abnormal 11.63 10.59 22 70143 3154 34883612
Bronchiolitis 11.63 10.59 22 70143 3154 34883612
Neoplasm progression 11.59 10.59 18 70147 23282 34863484
Hypo HDL cholesterolaemia 11.50 10.59 3 70162 9 34886757
Neurilemmoma benign 11.50 10.59 3 70162 9 34886757
Angina pectoris 11.48 10.59 29 70136 31334 34855432
Acute sinusitis 11.47 10.59 14 70151 1364 34885402
Hospitalisation 11.45 10.59 169 69996 56733 34830033
Diaphragmatic hernia 11.45 10.59 7 70158 263 34886503
Eosinophilic pleural effusion 11.40 10.59 7 70158 265 34886501
Heart rate irregular 11.39 10.59 9 70156 15798 34870968
Hilar lymphadenopathy 11.29 10.59 12 70153 1006 34885760
Vertical infection transmission 11.26 10.59 3 70162 10 34886756
Chronic sinusitis 11.23 10.59 18 70147 2261 34884505
Toxic optic neuropathy 11.21 10.59 11 70154 839 34885927
Abdominal wall haematoma 11.17 10.59 16 70149 1821 34884945
Ischaemic limb pain 11.17 10.59 4 70161 42 34886724
Disorientation 11.16 10.59 32 70133 33156 34853610
Interstitial granulomatous dermatitis 11.16 10.59 6 70159 176 34886590
Pneumonia staphylococcal 11.14 10.59 21 70144 3003 34883763
Oral candidiasis 11.11 10.59 51 70114 12059 34874707
Mycobacterium abscessus infection 11.08 10.59 9 70156 535 34886231
Drug level increased 10.97 10.59 79 70086 22017 34864749
Hyperaemia 10.90 10.59 13 70152 1236 34885530
Pustule 10.89 10.59 9 70156 548 34886218
Aplastic anaemia 10.89 10.59 3 70162 9713 34877053
Lethargy 10.87 10.59 44 70121 41078 34845688
Purpura senile 10.84 10.59 3 70162 12 34886754
Tremor 10.68 10.59 110 70055 82477 34804289
Neurological symptom 10.67 10.59 25 70140 4160 34882606
Inflammatory marker increased 10.67 10.59 28 70137 5000 34881766
Atrial conduction time prolongation 10.64 10.59 3 70162 13 34886753
Eye swelling 10.62 10.59 44 70121 9951 34876815

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 2489.30 9.70 5216 139534 901999 78697639
Infective pulmonary exacerbation of cystic fibrosis 1130.82 9.70 524 144226 12327 79587311
Electrocardiogram QT prolonged 676.29 9.70 827 143923 89559 79510079
Drug hypersensitivity 636.89 9.70 1563 143187 297353 79302285
Asthma 540.58 9.70 918 143832 134177 79465461
Abortion incomplete 522.18 9.70 200 144550 2864 79596774
Drug ineffective for unapproved indication 411.16 9.70 486 144264 50752 79548886
Wheezing 354.32 9.70 704 144046 115960 79483678
Cystic fibrosis 328.20 9.70 154 144596 3726 79595912
Bronchiectasis 326.69 9.70 293 144457 22093 79577545
Completed suicide 322.61 9.70 35 144715 245732 79353906
Product use in unapproved indication 289.24 9.70 1055 143695 249304 79350334
Long QT syndrome 216.72 9.70 135 144615 5820 79593818
Cough 214.63 9.70 1266 143484 365523 79234115
Synovitis 212.41 9.70 16 144734 150718 79448920
Drug interaction 209.20 9.70 1379 143371 413804 79185834
Contraindicated product administered 207.77 9.70 22 144728 157516 79442122
Drug abuse 206.39 9.70 26 144724 162665 79436973
Haemoptysis 200.94 9.70 363 144387 55636 79544002
Sleep disorder due to a general medical condition 194.86 9.70 180 144570 14097 79585541
Breath sounds abnormal 194.28 9.70 189 144561 15795 79583843
Obstructive airways disorder 189.84 9.70 259 144491 31200 79568438
Productive cough 185.47 9.70 460 144290 87871 79511767
Joint swelling 183.09 9.70 153 144597 288493 79311145
Therapeutic product effect decreased 163.94 9.70 47 144703 163816 79435822
Arthralgia 161.55 9.70 517 144233 571286 79028352
Full blood count abnormal 157.64 9.70 272 144478 40202 79559436
Hand deformity 155.46 9.70 8 144742 103911 79495727
Rhinitis allergic 152.74 9.70 147 144603 12122 79587516
Pulmonary function test decreased 150.74 9.70 119 144631 7518 79592120
Sputum discoloured 149.72 9.70 191 144559 21552 79578086
Asthma-chronic obstructive pulmonary disease overlap syndrome 148.39 9.70 85 144665 3136 79596502
Nasal polyps 146.41 9.70 115 144635 7212 79592426
Immune reconstitution inflammatory syndrome 144.99 9.70 151 144599 13690 79585948
Fall 144.69 9.70 431 144319 487198 79112440
Rheumatoid arthritis 141.64 9.70 103 144647 208367 79391271
Chronic obstructive pulmonary disease 140.09 9.70 406 144344 85013 79514625
Premature delivery 136.77 9.70 190 144560 23277 79576361
Anti-cyclic citrullinated peptide antibody positive 136.24 9.70 3 144747 83140 79516498
Toxicity to various agents 134.30 9.70 360 144390 421180 79178458
Arthropathy 130.42 9.70 80 144670 177031 79422607
Hypertransaminasaemia 128.35 9.70 132 144618 11792 79587846
Alopecia 125.34 9.70 141 144609 231214 79368424
Eosinophilia 120.32 9.70 259 144491 45086 79554552
Respiratory failure 119.83 9.70 646 144104 180265 79419373
Drug effective for unapproved indication 119.50 9.70 94 144656 5907 79593731
Cholecystitis chronic 118.27 9.70 116 144634 9790 79589848
Stevens-Johnson syndrome 113.58 9.70 232 144518 38934 79560704
Fatigue 113.32 9.70 1111 143639 928616 78671022
Systemic lupus erythematosus 111.85 9.70 40 144710 121109 79478529
Glossodynia 108.33 9.70 27 144723 103310 79496328
Malignant neoplasm progression 106.43 9.70 57 144693 135933 79463705
Pulmonary function test abnormal 105.01 9.70 75 144675 4069 79595569
Pneumonia 104.87 9.70 1731 143019 658515 78941123
Hypoxia 103.31 9.70 416 144334 102827 79496811
Forced expiratory volume decreased 99.88 9.70 95 144655 7719 79591919
Total lung capacity increased 98.85 9.70 58 144692 2240 79597398
Pathogen resistance 98.76 9.70 126 144624 14216 79585422
Torsade de pointes 97.40 9.70 146 144604 19166 79580472
Helicobacter infection 96.49 9.70 8 144742 69696 79529942
Wound 96.47 9.70 45 144705 116134 79483504
Ototoxicity 96.45 9.70 65 144685 3209 79596429
Hepatitis 96.33 9.70 270 144480 55457 79544181
Dyspnoea 96.11 9.70 2130 142620 854895 78744743
Rheumatoid factor positive 94.89 9.70 3 144747 59836 79539802
Acute respiratory distress syndrome 94.05 9.70 231 144519 43836 79555802
Chronic sinusitis 93.76 9.70 117 144633 12909 79586729
Congenital hiatus hernia 92.95 9.70 40 144710 784 79598854
No adverse event 91.39 9.70 206 144544 36986 79562652
Transaminases increased 89.74 9.70 251 144499 51492 79548146
Bronchopulmonary aspergillosis 89.66 9.70 152 144598 22142 79577496
Swelling 88.73 9.70 161 144589 216550 79383088
Intentional overdose 88.04 9.70 41 144709 105919 79493719
Somnolence 87.98 9.70 189 144561 238792 79360846
Upper respiratory tract infection 86.98 9.70 362 144388 90806 79508832
Death 86.79 9.70 637 144113 565877 79033761
Mobility decreased 86.07 9.70 58 144692 122117 79477521
Haemorrhage 83.97 9.70 358 144392 90760 79508878
Drug resistance 81.46 9.70 213 144537 42000 79557638
Confusional state 81.15 9.70 300 144450 317697 79281941
Photodermatosis 80.72 9.70 38 144712 926 79598712
Solar lentigo 77.82 9.70 39 144711 1094 79598544
Peripheral swelling 77.19 9.70 242 144508 269375 79330263
Pericarditis 76.82 9.70 47 144703 104189 79495449
Vanishing bile duct syndrome 76.81 9.70 45 144705 1733 79597905
Cystic fibrosis respiratory infection suppression 75.72 9.70 29 144721 415 79599223
Upper-airway cough syndrome 74.70 9.70 99 144651 11594 79588044
Febrile neutropenia 74.42 9.70 196 144554 230803 79368835
Dysplastic naevus 74.15 9.70 31 144719 564 79599074
Acute generalised exanthematous pustulosis 72.54 9.70 120 144630 17134 79582504
Bronchopulmonary aspergillosis allergic 72.10 9.70 53 144697 3008 79596630
Emotional distress 71.39 9.70 196 144554 39773 79559865
Infusion related reaction 69.95 9.70 201 144549 230036 79369602
Condition aggravated 69.76 9.70 1287 143463 499837 79099801
Toxic epidermal necrolysis 69.34 9.70 208 144542 44373 79555265
Injury 68.73 9.70 301 144449 77195 79522443
Chest discomfort 68.35 9.70 457 144293 137587 79462051
Eosinophil count abnormal 67.22 9.70 31 144719 720 79598918
Sputum increased 66.54 9.70 60 144690 4553 79595085
Drug intolerance 64.88 9.70 253 144497 263866 79335772
Mycobacterium avium complex infection 64.72 9.70 59 144691 4541 79595097
Lung opacity 60.67 9.70 60 144690 5114 79594524
Sleep disorder due to general medical condition, insomnia type 60.28 9.70 5 144745 43551 79556087
Stomatitis 60.07 9.70 109 144641 146648 79452990
Bronchitis 59.64 9.70 424 144326 130220 79469418
Overdose 59.55 9.70 156 144594 184050 79415588
Drug reaction with eosinophilia and systemic symptoms 58.86 9.70 252 144498 63992 79535646
Neutropenia 57.79 9.70 297 144453 287413 79312225
Infective exacerbation of bronchiectasis 57.19 9.70 28 144722 746 79598892
Exposure during pregnancy 56.97 9.70 346 144404 100786 79498852
Stenotrophomonas infection 56.25 9.70 50 144700 3723 79595915
Pseudomonas infection 56.14 9.70 120 144630 20783 79578855
Lip oedema 55.82 9.70 63 144687 6253 79593385
Myasthenia gravis crisis 55.73 9.70 31 144719 1080 79598558
Oral candidiasis 55.63 9.70 148 144602 29480 79570158
Biliary dyskinesia 55.33 9.70 42 144708 2503 79597135
Musculoskeletal stiffness 55.21 9.70 150 144600 174858 79424780
Factor V inhibition 54.81 9.70 22 144728 359 79599279
Dehydration 54.61 9.70 248 144502 247939 79351699
Therapeutic product effect incomplete 54.16 9.70 441 144309 141204 79458434
Coma 53.74 9.70 62 144688 100587 79499051
Discomfort 53.49 9.70 91 144659 125526 79474112
Deafness 53.34 9.70 118 144632 20919 79578719
Ear pruritus 52.54 9.70 50 144700 4065 79595573
Chest X-ray abnormal 50.75 9.70 67 144683 7816 79591822
Pneumothorax 50.69 9.70 139 144611 28184 79571454
Irritable bowel syndrome 50.30 9.70 25 144725 62216 79537422
Impaired healing 50.12 9.70 51 144699 87604 79512034
COVID-19 pneumonia 50.07 9.70 140 144610 28709 79570929
Pneumomediastinum 49.58 9.70 46 144704 3621 79596017
Dizziness 49.43 9.70 666 144084 525775 79073863
Alanine aminotransferase increased 49.22 9.70 481 144269 162089 79437549
Rales 48.26 9.70 110 144640 19891 79579747
Cognitive disorder 48.17 9.70 34 144716 69892 79529746
Acute respiratory failure 48.11 9.70 225 144525 59316 79540322
Aspergillus infection 48.04 9.70 107 144643 19054 79580584
Product packaging quantity issue 47.62 9.70 30 144720 1319 79598319
COVID-19 treatment 47.13 9.70 21 144729 449 79599189
Macular degeneration 46.73 9.70 78 144672 11218 79588420
Cystic fibrosis related diabetes 46.72 9.70 17 144733 209 79599429
Suicide attempt 46.58 9.70 49 144701 82883 79516755
Drug-induced liver injury 46.39 9.70 240 144510 65877 79533761
General physical health deterioration 46.22 9.70 301 144449 274937 79324701
Mucormycosis 45.55 9.70 66 144684 8403 79591235
Mucocutaneous disorder 45.41 9.70 15 144735 135 79599503
Respiration abnormal 45.29 9.70 63 144687 7725 79591913
Lung diffusion disorder 45.25 9.70 16 144734 180 79599458
Hepatitis acute 44.98 9.70 92 144658 15450 79584188
Sarcoidosis 44.89 9.70 65 144685 8270 79591368
Abdominal discomfort 44.78 9.70 269 144481 250458 79349180
Lung transplant rejection 44.15 9.70 30 144720 1501 79598137
Ventilation perfusion mismatch 43.87 9.70 22 144728 618 79599020
Hypofibrinogenaemia 43.44 9.70 33 144717 1969 79597669
Distal intestinal obstruction syndrome 42.34 9.70 23 144727 764 79598874
Respiratory disorder 41.90 9.70 177 144573 44679 79554959
Actinic keratosis 41.47 9.70 53 144697 5989 79593649
Paraesthesia oral 41.25 9.70 105 144645 20366 79579272
Hypertriglyceridaemia 41.19 9.70 79 144671 12661 79586977
Obliterative bronchiolitis 40.97 9.70 38 144712 2990 79596648
Heart sounds 40.55 9.70 24 144726 942 79598696
Total lung capacity decreased 40.36 9.70 37 144713 2868 79596770
Sedation 40.22 9.70 22 144728 51873 79547765
Mycobacterial infection 40.19 9.70 41 144709 3627 79596011
Contusion 40.14 9.70 137 144613 148639 79450999
Hepatocellular injury 40.04 9.70 182 144568 47411 79552227
Bronchiolitis obliterans syndrome 40.04 9.70 17 144733 322 79599316
Gastrointestinal haemorrhage 39.87 9.70 136 144614 147583 79452055
Cholelithiasis 39.64 9.70 195 144555 52469 79547169
Parathyroid gland enlargement 39.48 9.70 14 144736 159 79599479
Urinary tract infection 38.94 9.70 315 144435 274197 79325441
Atypical mycobacterial infection 38.42 9.70 29 144721 1714 79597924
Hyponatraemia 38.34 9.70 179 144571 177669 79421969
Vaginal flatulence 38.14 9.70 34 144716 2541 79597097
Adverse event 38.01 9.70 32 144718 60182 79539456
Gastrooesophageal reflux disease 37.94 9.70 321 144429 103925 79495713
Hepatitis cholestatic 37.75 9.70 80 144670 13772 79585866
Forced expiratory volume 37.46 9.70 12 144738 97 79599541
Hypotension 37.44 9.70 568 144182 439749 79159889
Hypercapnia 37.37 9.70 62 144688 8873 79590765
Auscultation 37.19 9.70 7 144743 0 79599638
Cholestasis 37.14 9.70 190 144560 51919 79547719
Injection site pain 36.79 9.70 117 144633 129721 79469917
Graft versus host disease in lung 36.57 9.70 22 144728 890 79598748
Pulmonary embolism 36.54 9.70 474 144276 171180 79428458
Bronchomalacia 36.44 9.70 15 144735 262 79599376
Prostate cancer 36.23 9.70 8 144742 33260 79566378
Influenza 36.11 9.70 377 144373 129229 79470409
Disease progression 36.05 9.70 192 144558 184170 79415468
Decreased appetite 35.90 9.70 423 144327 341995 79257643
Eosinophil count increased 35.79 9.70 89 144661 17016 79582622
Tachyarrhythmia 35.63 9.70 53 144697 6909 79592729
Malignant melanoma in situ 35.58 9.70 32 144718 2420 79597218
Knee arthroplasty 35.51 9.70 17 144733 43231 79556407
C-reactive protein abnormal 35.36 9.70 22 144728 48345 79551293
Blister 35.03 9.70 106 144644 119370 79480268
Prolonged expiration 34.52 9.70 24 144726 1247 79598391
Urticaria 34.36 9.70 499 144251 184702 79414936
Joint range of motion decreased 34.29 9.70 9 144741 33273 79566365
Folliculitis 34.27 9.70 30 144720 55350 79544288
COVID-19 34.23 9.70 437 144313 157237 79442401
Palmar-plantar erythrodysaesthesia syndrome 34.06 9.70 9 144741 33125 79566513
Pneumothorax spontaneous 33.85 9.70 25 144725 1429 79598209
HIV associated nephropathy 33.61 9.70 15 144735 322 79599316
Rhinocerebral mucormycosis 33.57 9.70 22 144728 1036 79598602
Bronchial wall thickening 33.55 9.70 32 144718 2609 79597029
Deafness neurosensory 33.15 9.70 51 144699 6847 79592791
Platelet count decreased 33.11 9.70 212 144538 194452 79405186
Fungal disease carrier 32.82 9.70 15 144735 341 79599297
Pain in extremity 32.79 9.70 465 144285 364073 79235565
Injection site swelling 32.35 9.70 23 144727 47109 79552529
Immunodeficiency common variable 32.34 9.70 15 144735 353 79599285
Respiratory tract infection 32.28 9.70 174 144576 48515 79551123
Myocardial infarction 32.11 9.70 199 144551 183930 79415708
Blood pressure fluctuation 32.06 9.70 45 144705 67100 79532538
Rhinorrhoea 31.90 9.70 242 144508 75832 79523806
Nasal congestion 31.81 9.70 243 144507 76309 79523329
Neutrophil count decreased 31.56 9.70 78 144672 93881 79505757
Impaired quality of life 31.31 9.70 76 144674 14310 79585328
Emphysema 31.19 9.70 82 144668 16218 79583420
Osteonecrosis of jaw 31.14 9.70 20 144730 43206 79556432
Cryptococcosis 31.14 9.70 35 144715 3458 79596180
Gallbladder disorder 30.79 9.70 91 144659 19249 79580389
Rheumatic fever 30.78 9.70 7 144743 28518 79571120
Procedural pain 30.66 9.70 102 144648 22982 79576656
Orthostatic hypotension 30.63 9.70 34 144716 56130 79543508
Cryptococcal meningoencephalitis 30.58 9.70 13 144737 247 79599391
Cardiac failure 30.41 9.70 161 144589 154681 79444957
Treatment failure 30.38 9.70 183 144567 170303 79429335
Injection site erythema 30.30 9.70 60 144690 78137 79521501
Constipation 30.30 9.70 348 144402 282702 79316936
Sopor 30.28 9.70 11 144739 32999 79566639
Pregnancy 29.94 9.70 112 144638 26739 79572899
Upper respiratory fungal infection 29.74 9.70 14 144736 341 79599297
Cystic fibrosis pancreatic 29.73 9.70 9 144741 59 79599579
Symmetrical drug-related intertriginous and flexural exanthema 29.53 9.70 19 144731 867 79598771
Middle lobe syndrome 29.30 9.70 8 144742 34 79599604
Hypokalaemia 29.28 9.70 148 144602 143892 79455746
Tinnitus 29.09 9.70 158 144592 44175 79555463
Hepatic enzyme increased 28.99 9.70 203 144547 182407 79417231
Myoclonic dystonia 28.98 9.70 9 144741 65 79599573
Device expulsion 28.61 9.70 6 144744 25855 79573783
Rash maculo-papular 28.55 9.70 187 144563 55891 79543747
Lung infiltration 28.46 9.70 99 144651 22813 79576825
Mucosal inflammation 28.43 9.70 59 144691 75521 79524117
Jarisch-Herxheimer reaction 28.19 9.70 19 144731 938 79598700
Depressed level of consciousness 28.15 9.70 86 144664 96566 79503072
Bronchial hyperreactivity 28.03 9.70 31 144719 3009 79596629
Gait disturbance 27.66 9.70 242 144508 207264 79392374
Alveolitis 27.64 9.70 36 144714 4144 79595494
Pneumonia pseudomonal 27.43 9.70 43 144707 5868 79593770
Proctitis 27.39 9.70 45 144705 6387 79593251
Pain 27.23 9.70 1024 143726 702778 78896860
Lung disorder 27.19 9.70 244 144506 80313 79519325
Female genital tract fistula 27.08 9.70 43 144707 5932 79593706
Dyspnoea exertional 27.01 9.70 259 144491 86814 79512824
NPM1 gene mutation 26.98 9.70 10 144740 130 79599508
Oropharyngeal pain 26.74 9.70 310 144440 109043 79490595
Metastases to liver 26.72 9.70 9 144741 28305 79571333
Factor V deficiency 26.68 9.70 9 144741 87 79599551
Cytokine storm 26.66 9.70 19 144731 1027 79598611
Gait inability 26.65 9.70 41 144709 58876 79540762
Prescribed overdose 26.65 9.70 18 144732 37865 79561773
Herpes simplex viraemia 26.57 9.70 14 144736 437 79599201
Eosinophilic pneumonia 26.57 9.70 40 144710 5270 79594368
Asthenia 26.39 9.70 717 144033 510972 79088666
Pharyngeal erythema 26.34 9.70 25 144725 2025 79597613
Metastases to bone 26.34 9.70 6 144744 24421 79575217
Liver function test increased 26.27 9.70 142 144608 39631 79560007
Fibromyalgia 26.13 9.70 48 144702 64292 79535346
Cystic fibrosis lung 26.12 9.70 10 144740 143 79599495
Dysarthria 26.10 9.70 52 144698 67570 79532068
Sputum retention 25.85 9.70 19 144731 1078 79598560
Platelet count increased 25.43 9.70 94 144656 22312 79577326
Rash maculovesicular 25.41 9.70 7 144743 31 79599607
HIV infection 25.39 9.70 19 144731 1108 79598530
Pneumonia bacterial 25.30 9.70 85 144665 19246 79580392
Cardiac arrest 25.26 9.70 446 144304 171650 79427988
Lung transplant 25.19 9.70 36 144714 4525 79595113
Hip arthroplasty 25.14 9.70 17 144733 35739 79563899
Bladder cancer 25.04 9.70 3 144747 19523 79580115
Pneumonia mycoplasmal 24.90 9.70 21 144729 1457 79598181
Seizure 24.82 9.70 221 144529 188613 79411025
Viral infection 24.74 9.70 148 144602 42868 79556770
Accidental exposure to product 24.68 9.70 13 144737 31309 79568329
Type 2 diabetes mellitus 24.66 9.70 41 144709 57081 79542557
Pulmonary vasculitis 24.58 9.70 16 144734 745 79598893
Inguinal hernia repair 24.57 9.70 12 144738 318 79599320
Atypical mycobacterial lower respiratory tract infection 24.27 9.70 10 144740 175 79599463
Hepatotoxicity 24.20 9.70 168 144582 51184 79548454
Respiratory syncytial virus infection 24.13 9.70 53 144697 9349 79590289
Mechanical urticaria 24.09 9.70 13 144737 426 79599212
Balance disorder 24.05 9.70 95 144655 98762 79500876
Breast cancer 23.83 9.70 16 144734 33765 79565873
Forced vital capacity decreased 23.83 9.70 22 144728 1721 79597917
Hallucinations, mixed 23.82 9.70 44 144706 6855 79592783
Blood pressure increased 23.74 9.70 257 144493 211103 79388535
Psoriatic arthropathy 23.73 9.70 68 144682 77931 79521707
Endometritis 23.70 9.70 16 144734 792 79598846
Urethritis mycoplasmal 23.60 9.70 6 144744 18 79599620
Mixed liver injury 23.29 9.70 46 144704 7532 79592106
Injection site bruising 23.27 9.70 24 144726 40978 79558660
Hypertension 23.22 9.70 442 144308 330550 79269088
White blood cell count decreased 23.18 9.70 224 144526 188064 79411574
Pancreatic failure 23.14 9.70 21 144729 1607 79598031
Ascites 22.90 9.70 66 144684 75496 79524142
Cardiac murmur 22.90 9.70 72 144678 15752 79583886
Injection site haemorrhage 22.81 9.70 11 144739 27859 79571779
Aspartate aminotransferase increased 22.79 9.70 366 144384 138275 79461363
Ventricular tachycardia 22.68 9.70 142 144608 41793 79557845
Chronic kidney disease 22.65 9.70 201 144549 65953 79533685
Hilar lymphadenopathy 22.62 9.70 22 144728 1837 79597801
Flank pain 22.31 9.70 83 144667 19761 79579877
Iris transillumination defect 22.25 9.70 9 144741 150 79599488
SJS-TEN overlap 22.19 9.70 15 144735 744 79598894
Intentional product misuse 22.18 9.70 93 144657 95072 79504566
Injection site reaction 22.13 9.70 41 144709 54744 79544894
Pharyngeal enanthema 21.92 9.70 7 144743 56 79599582
Conjunctival hyperaemia 21.73 9.70 33 144717 4380 79595258
Muscular weakness 21.61 9.70 187 144563 160542 79439096
Pneumonia aspiration 21.40 9.70 57 144693 66910 79532728
Vaginal discharge 21.38 9.70 44 144706 7419 79592219
Sinus congestion 21.36 9.70 82 144668 19814 79579824
Myelosuppression 21.31 9.70 25 144725 40271 79559367
Loss of personal independence in daily activities 21.29 9.70 282 144468 102298 79497340
Hospitalisation 21.22 9.70 263 144487 93973 79505665
Methaemoglobinaemia 21.18 9.70 37 144713 5520 79594118
Agranulocytosis 21.03 9.70 147 144603 44883 79554755
Blood immunoglobulin E increased 20.92 9.70 38 144712 5844 79593794
Tachypnoea 20.86 9.70 114 144636 31949 79567689
Jaundice cholestatic 20.81 9.70 56 144694 11228 79588410
Coinfection 20.72 9.70 7 144743 68 79599570
Drug ineffective 20.60 9.70 2251 142499 1078662 78520976
Bacterial pericarditis 20.54 9.70 7 144743 70 79599568
Small intestinal obstruction 20.50 9.70 12 144738 27260 79572378
Foot deformity 20.48 9.70 9 144741 24065 79575573
Multiple sclerosis relapse 20.46 9.70 33 144717 46500 79553138
Cerebral infarction 20.45 9.70 32 144718 45644 79553994
Fracture 20.45 9.70 7 144743 21794 79577844
Hepatomegaly 20.44 9.70 78 144672 18796 79580842
Blood lactic acid increased 20.32 9.70 60 144690 12684 79586954
Hypoglycaemia 20.30 9.70 105 144645 101489 79498149
Appetite disorder 20.29 9.70 44 144706 7695 79591943
Uterine perforation 20.27 9.70 39 144711 6264 79593374
C-reactive protein increased 20.20 9.70 144 144606 128883 79470755
Osteoarthritis 19.93 9.70 86 144664 87223 79512415
Dystonia 19.85 9.70 7 144743 21392 79578246
Chimerism 19.78 9.70 10 144740 286 79599352
Ill-defined disorder 19.63 9.70 58 144692 65817 79533821
Anosmia 19.55 9.70 47 144703 8797 79590841
Palatal oedema 19.44 9.70 18 144732 1413 79598225
Urosepsis 19.44 9.70 12 144738 26483 79573155
Granulomatosis with polyangiitis 19.42 9.70 25 144725 2845 79596793
Hypoaesthesia 19.38 9.70 220 144530 179132 79420506
Mycoplasma infection 19.35 9.70 14 144736 775 79598863
Hyperbilirubinaemia 19.32 9.70 92 144658 24426 79575212
Genital ulceration 19.30 9.70 16 144734 1084 79598554
Musculoskeletal pain 19.22 9.70 108 144642 102246 79497392
Blood glucose increased 19.14 9.70 126 144624 114849 79484789
Therapeutic response decreased 19.10 9.70 60 144690 66793 79532845
Anhedonia 19.05 9.70 65 144685 14833 79584805
Blood immunoglobulin G decreased 18.97 9.70 27 144723 3382 79596256
Lung hyperinflation 18.97 9.70 20 144730 1839 79597799
Drug level increased 18.85 9.70 130 144620 39521 79560117
Sneezing 18.63 9.70 78 144672 19605 79580033
Sinus polyp degeneration 18.57 9.70 6 144744 50 79599588
Antinuclear antibody negative 18.56 9.70 5 144745 20 79599618
Andersen-Tawil syndrome 18.49 9.70 4 144746 4 79599634
Meningism 18.27 9.70 13 144737 701 79598937
Prescribed underdose 18.24 9.70 16 144734 29498 79570140
Diabetic ketoacidosis 18.23 9.70 21 144729 34101 79565537
Back pain 18.15 9.70 417 144333 303763 79295875
Neoplasm progression 18.07 9.70 42 144708 51640 79547998
Increased bronchial secretion 18.00 9.70 26 144724 3301 79596337
Abdominal wall haematoma 17.99 9.70 32 144718 4841 79594797
Adverse drug reaction 17.99 9.70 61 144689 66331 79533307
Pelvic inflammatory disease 17.93 9.70 17 144733 1375 79598263
Hypogammaglobulinaemia 17.89 9.70 58 144692 12893 79586745
Basal cell carcinoma 17.89 9.70 25 144725 37350 79562288
Benign prostatic hyperplasia 17.88 9.70 54 144696 11558 79588080
Restrictive allograft syndrome 17.82 9.70 5 144745 24 79599614
Poisoning 17.79 9.70 12 144738 25260 79574378
Hyperkalaemia 17.74 9.70 128 144622 114270 79485368
Hypomania 17.66 9.70 41 144709 7503 79592135
Urethral discharge 17.60 9.70 4 144746 6 79599632
Red blood cell sedimentation rate abnormal 17.58 9.70 8 144742 20955 79578683
Dry mouth 17.57 9.70 91 144659 87928 79511710
Lip erythema 17.44 9.70 9 144741 269 79599369
Nasal mucosal disorder 17.43 9.70 10 144740 370 79599268
Disseminated cryptococcosis 17.42 9.70 19 144731 1815 79597823
Bronchial disorder 17.35 9.70 22 144728 2467 79597171
Lower gastrointestinal haemorrhage 17.31 9.70 4 144746 16121 79583517
Cardiac failure congestive 17.28 9.70 170 144580 142232 79457406
Vaginal stricture 17.22 9.70 4 144746 7 79599631
Disturbance in attention 17.19 9.70 42 144708 50759 79548879
Gallbladder cholesterolosis 17.08 9.70 12 144738 634 79599004
Respiratory depression 17.05 9.70 15 144735 27615 79572023
Fluid retention 17.03 9.70 67 144683 69742 79529896
Rash erythematous 17.01 9.70 170 144580 57599 79542039
Interstitial lung disease 16.98 9.70 127 144623 112473 79487165
Pseudomembranous colitis 16.98 9.70 33 144717 5341 79594297
Leukocytosis 16.98 9.70 136 144614 43319 79556319
Infective chondritis 16.89 9.70 5 144745 30 79599608
Rhonchi 16.87 9.70 28 144722 4008 79595630
Muscle spasticity 16.79 9.70 9 144741 21466 79578172
Erythema multiforme 16.75 9.70 70 144680 17581 79582057
Weight increased 16.62 9.70 380 144370 277006 79322632
Gastroenteritis staphylococcal 16.57 9.70 9 144741 299 79599339
Amniotic cavity infection 16.57 9.70 13 144737 814 79598824
Crystal arthropathy 16.55 9.70 8 144742 207 79599431
Enterovirus infection 16.49 9.70 19 144731 1928 79597710
Pulmonary alveolar haemorrhage 16.46 9.70 52 144698 11405 79588233
Inappropriate schedule of product administration 16.43 9.70 159 144591 133469 79466169
Headache 16.35 9.70 996 143754 652776 78946862
Oropharyngeal candidiasis 16.34 9.70 18 144732 1739 79597899
Kawasaki's disease 16.26 9.70 4 144746 10 79599628
Paranasal sinus discomfort 16.12 9.70 29 144721 4427 79595211
Joint stiffness 16.10 9.70 31 144719 40799 79558839
Aphthous ulcer 16.05 9.70 67 144683 16822 79582816
Staphylococcal infection 15.96 9.70 169 144581 58126 79541512
Thoracic cavity drainage test abnormal 15.94 9.70 3 144747 0 79599638
Bronchogram abnormal 15.94 9.70 3 144747 0 79599638
Portal hypertensive enteropathy 15.94 9.70 3 144747 0 79599638
Carbon dioxide increased 15.93 9.70 20 144730 2220 79597418
Respiratory distress 15.91 9.70 169 144581 58170 79541468
Gallbladder injury 15.90 9.70 15 144735 1206 79598432
Total lung capacity abnormal 15.85 9.70 8 144742 228 79599410
Pneumonia necrotising 15.84 9.70 15 144735 1212 79598426
Macule 15.84 9.70 23 144727 2934 79596704
Noninfective conjunctivitis 15.76 9.70 5 144745 39 79599599
Diffuse panbronchiolitis 15.73 9.70 4 144746 12 79599626
Pyrexia 15.72 9.70 1433 143317 677276 78922362
Extrapyramidal disorder 15.65 9.70 11 144739 22668 79576970
Diverticulitis 15.53 9.70 38 144712 45898 79553740
Pneumonia staphylococcal 15.48 9.70 30 144720 4844 79594794
Local reaction 15.41 9.70 11 144739 596 79599042
Device malfunction 15.34 9.70 10 144740 21438 79578200
Pancreatic carcinoma 15.33 9.70 3 144747 13574 79586064
Infantile vomiting 15.26 9.70 4 144746 14 79599624
Injection site warmth 15.26 9.70 4 144746 14803 79584835
Vaginal cellulitis 15.23 9.70 6 144744 93 79599545
Skin ulcer 15.19 9.70 49 144701 54101 79545537
Micturition urgency 15.17 9.70 54 144696 12587 79587051
Pulmonary infarction 15.15 9.70 26 144724 3823 79595815
Bacterial infection 15.13 9.70 103 144647 31177 79568461
Underdose 15.06 9.70 23 144727 33128 79566510
HIV viraemia 15.00 9.70 6 144744 97 79599541
Malabsorption from administration site 14.97 9.70 7 144743 168 79599470
Miosis 14.93 9.70 5 144745 15784 79583854
Staphylococcus test positive 14.93 9.70 35 144715 6446 79593192
Immunosuppressant drug level increased 14.87 9.70 43 144707 8984 79590654
Haematemesis 14.87 9.70 47 144703 52217 79547421
Pigment nephropathy 14.85 9.70 5 144745 48 79599590
Peak expiratory flow rate abnormal 14.83 9.70 6 144744 100 79599538
Haemolysis 14.75 9.70 54 144696 12758 79586880
Maternal exposure during pregnancy 14.74 9.70 338 144412 136200 79463438
Neuritis 14.63 9.70 17 144733 1741 79597897
Second primary malignancy 14.56 9.70 4 144746 14346 79585292
Febrile bone marrow aplasia 14.44 9.70 3 144747 13017 79586621
Localised infection 14.41 9.70 29 144721 37546 79562092
Infusion site streaking 14.41 9.70 10 144740 518 79599120
Respiratory tract congestion 14.39 9.70 73 144677 19881 79579757
Subcutaneous emphysema 14.35 9.70 17 144733 1777 79597861
Altered state of consciousness 14.23 9.70 37 144713 43785 79555853
Disorientation 14.22 9.70 62 144688 62714 79536924
Vasculitis 14.20 9.70 86 144664 25016 79574622
Rhinovirus infection 14.20 9.70 39 144711 7914 79591724
Atypical mycobacterium test positive 14.12 9.70 4 144746 20 79599618
Tubulointerstitial nephritis 14.04 9.70 118 144632 38117 79561521
Inflammation 14.01 9.70 106 144644 93647 79505991
Eye pruritus 13.96 9.70 74 144676 20496 79579142
Oral blood blister 13.96 9.70 4 144746 21 79599617
Respiratory tract inflammation 13.94 9.70 12 144738 856 79598782
Rash morbilliform 13.93 9.70 33 144717 6117 79593521
Senile pruritus 13.87 9.70 3 144747 3 79599635
Deafness unilateral 13.80 9.70 26 144724 4112 79595526
Acoustic neuroma 13.77 9.70 8 144742 303 79599335
Purpura 13.77 9.70 71 144679 19456 79580182
Hepatic necrosis 13.72 9.70 42 144708 9058 79590580
Renal injury 13.69 9.70 64 144686 16863 79582775
Dizziness exertional 13.66 9.70 10 144740 564 79599074
Catastrophic reaction 13.66 9.70 4 144746 23 79599615
End stage renal disease 13.65 9.70 51 144699 12169 79587469
Mycoplasma test positive 13.63 9.70 7 144743 207 79599431
Cytokine release syndrome 13.62 9.70 28 144722 35970 79563668
Arthritis 13.58 9.70 138 144612 114742 79484896
Hyperaemia 13.57 9.70 22 144728 3088 79596550
Herpes zoster 13.56 9.70 106 144644 92977 79506661
Disseminated mycobacterium avium complex infection 13.54 9.70 7 144743 210 79599428
Pleural fistula 13.51 9.70 4 144746 24 79599614
Pneumonia serratia 13.38 9.70 4 144746 25 79599613
Eosinophilic pneumonia acute 13.37 9.70 13 144737 1085 79598553
Incorrect route of product administration 13.36 9.70 27 144723 34902 79564736
Hypersensitivity 13.34 9.70 368 144382 261871 79337767
Oral mucosa erosion 13.24 9.70 17 144733 1930 79597708
Dyshidrotic eczema 13.22 9.70 10 144740 593 79599045
Pancreatitis acute 13.20 9.70 143 144607 49461 79550177
Pelvic fracture 13.16 9.70 3 144747 12201 79587437
Procedural anxiety 13.14 9.70 11 144739 755 79598883
Presyncope 13.08 9.70 35 144715 41019 79558619
Gonorrhoea 13.04 9.70 7 144743 227 79599411
Depressed mood 13.01 9.70 140 144610 48340 79551298
Laryngeal mass 12.96 9.70 5 144745 73 79599565
Bacterial disease carrier 12.95 9.70 15 144735 1531 79598107
Anal skin tags 12.94 9.70 9 144741 468 79599170
Dysphonia 12.92 9.70 159 144591 56713 79542925
Asthmatic crisis 12.84 9.70 17 144733 1989 79597649
Alcohol intolerance 12.80 9.70 9 144741 476 79599162
Leukaemoid reaction 12.78 9.70 8 144742 348 79599290
Sepsis 12.72 9.70 382 144368 269046 79330592
Bronchial secretion retention 12.72 9.70 25 144725 4079 79595559
Lower limb fracture 12.72 9.70 14 144736 23201 79576437
Bronchospasm 12.71 9.70 83 144667 24776 79574862
Lacrimation increased 12.71 9.70 77 144673 22400 79577238
Oesophagogastroduodenoscopy 12.69 9.70 7 144743 240 79599398
Bronchial obstruction 12.65 9.70 20 144730 2748 79596890
Haemophilus infection 12.62 9.70 18 144732 2258 79597380
Clostridium difficile colitis 12.59 9.70 101 144649 32182 79567456
Laziness 12.58 9.70 11 144739 801 79598837
Wound infection 12.56 9.70 15 144735 23976 79575662
Head injury 12.56 9.70 31 144719 37338 79562300
Haemoglobin decreased 12.55 9.70 307 144443 221812 79377826
Haemorrhoids thrombosed 12.53 9.70 7 144743 246 79599392
Sensory loss 12.49 9.70 4 144746 12987 79586651
Rash pustular 12.46 9.70 47 144703 11264 79588374
Delusional disorder, persecutory type 12.43 9.70 9 144741 499 79599139
Injection site mass 12.41 9.70 11 144739 20173 79579465
Acute psychosis 12.40 9.70 25 144725 4155 79595483
Anaemia 12.36 9.70 671 144079 444344 79155294
Blood cholesterol increased 12.35 9.70 95 144655 83625 79516013
Ischaemic stroke 12.34 9.70 26 144724 33105 79566533
Occupational exposure to air contaminants 12.32 9.70 6 144744 158 79599480
Nosocomial infection 12.31 9.70 20 144730 2812 79596826
Bulimia nervosa 12.30 9.70 7 144743 255 79599383
Secretion discharge 12.30 9.70 57 144693 14965 79584673
Respiratory symptom 12.29 9.70 27 144723 4764 79594874
Liver function test 12.25 9.70 6 144744 160 79599478
FEV1/FVC ratio abnormal 12.21 9.70 4 144746 35 79599603
Urinary incontinence 12.20 9.70 36 144714 40873 79558765
Bronchopleural fistula 12.17 9.70 10 144740 669 79598969
Loss of consciousness 12.15 9.70 223 144527 167720 79431918
Bone pain 12.06 9.70 56 144694 55686 79543952
Q fever 12.03 9.70 7 144743 266 79599372
Muscle rigidity 12.02 9.70 11 144739 19871 79579767
Vulvovaginal pruritus 12.00 9.70 19 144731 2614 79597024
Acute sinusitis 12.00 9.70 26 144724 4544 79595094
Rheumatoid factor 12.00 9.70 8 144742 388 79599250
Blood alkaline phosphatase increased 11.98 9.70 172 144578 63492 79536146
Normal newborn 11.96 9.70 34 144716 7038 79592600
Cerebral haemorrhage 11.86 9.70 59 144691 57614 79542024
Hemianopia heteronymous 11.86 9.70 5 144745 93 79599545
Bursitis 11.84 9.70 30 144720 35814 79563824
Cystic fibrosis hepatic disease 11.83 9.70 4 144746 39 79599599
Hypo HDL cholesterolaemia 11.80 9.70 3 144747 9 79599629
Humidity intolerance 11.80 9.70 8 144742 399 79599239
Multiple-drug resistance 11.77 9.70 39 144711 8769 79590869
Poor feeding infant 11.76 9.70 6 144744 175 79599463
Status epilepticus 11.74 9.70 17 144733 25024 79574614
Syphilis 11.73 9.70 9 144741 545 79599093
Radiculopathy 11.73 9.70 39 144711 8785 79590853
Biopsy colon abnormal 11.71 9.70 5 144745 96 79599542
Vaginal abscess 11.71 9.70 8 144742 404 79599234
Nail pitting 11.64 9.70 8 144742 408 79599230
Product prescribing error 11.59 9.70 42 144708 44771 79554867
Mycobacterium chelonae infection 11.58 9.70 18 144732 2438 79597200
Multiple organ dysfunction syndrome 11.56 9.70 293 144457 119953 79479685
Panniculitis 11.56 9.70 4 144746 12367 79587271
Skin disorder 11.53 9.70 28 144722 33915 79565723
Hyperventilation 11.48 9.70 36 144714 7863 79591775
Superinfection bacterial 11.47 9.70 14 144736 1510 79598128
CD4 lymphocytes increased 11.46 9.70 7 144743 291 79599347
ADAMTS13 activity decreased 11.42 9.70 6 144744 186 79599452
Autoimmune hepatitis 11.39 9.70 47 144703 11736 79587902
Oesophageal injury 11.39 9.70 5 144745 103 79599535
Ruptured ectopic pregnancy 11.38 9.70 8 144742 423 79599215
Haemolytic anaemia 11.35 9.70 63 144687 17757 79581881
Bone density decreased 11.34 9.70 5 144745 13342 79586296
Borderline personality disorder 11.34 9.70 11 144739 916 79598722
Stomatococcal infection 11.31 9.70 7 144743 298 79599340
Ischaemic limb pain 11.31 9.70 4 144746 45 79599593
Peritonitis 11.31 9.70 21 144729 28015 79571623
Aphasia 11.31 9.70 45 144705 46687 79552951
Pneumonia acinetobacter 11.28 9.70 6 144744 191 79599447
Vulvovaginal candidiasis 11.27 9.70 18 144732 2496 79597142
Foetal heart rate deceleration abnormality 11.26 9.70 5 144745 106 79599532
Spinal pain 11.25 9.70 7 144743 15385 79584253
Akathisia 11.21 9.70 5 144745 13254 79586384
Pustule 11.21 9.70 16 144734 2009 79597629
Bronchiolitis 11.19 9.70 24 144726 4164 79595474
Pneumopericardium 11.19 9.70 6 144744 194 79599444
Lethargy 11.18 9.70 94 144656 81198 79518440
Hepatic cytolysis 11.17 9.70 86 144664 27065 79572573
Veillonella infection 11.16 9.70 4 144746 47 79599591
Neurological examination abnormal 11.14 9.70 9 144741 588 79599050
Papillary muscle rupture 11.13 9.70 3 144747 12 79599626
Neurilemmoma benign 11.13 9.70 3 144747 12 79599626
Interleukin level increased 11.12 9.70 9 144741 589 79599049
Systemic candida 11.10 9.70 32 144718 6674 79592964
Hepatosplenomegaly 11.07 9.70 30 144720 6039 79593599
Toxic optic neuropathy 11.05 9.70 12 144738 1141 79598497
Tooth discolouration 11.02 9.70 12 144738 1145 79598493
Toothache 10.99 9.70 12 144738 19958 79579680
Stillbirth 10.96 9.70 23 144727 3932 79595706
Swelling face 10.96 9.70 186 144564 71026 79528612
Face oedema 10.96 9.70 88 144662 28048 79571590
Oedema 10.92 9.70 152 144598 119428 79480210
Neurotoxicity 10.91 9.70 27 144723 32491 79567147
Choroiditis 10.91 9.70 13 144737 1368 79598270
Pulmonary mass 10.87 9.70 90 144660 28944 79570694
Kounis syndrome 10.83 9.70 24 144726 4258 79595380
Sciatica 10.83 9.70 28 144722 33194 79566444
Vulvovaginal burning sensation 10.81 9.70 14 144736 1603 79598035
Eosinophilic pustular folliculitis 10.81 9.70 5 144745 117 79599521
Bronchoalveolar lavage 10.72 9.70 4 144746 53 79599585
Cerebral toxoplasmosis 10.71 9.70 17 144733 2345 79597293
Dysentery 10.64 9.70 12 144738 1190 79598448
Eosinophilic pleural effusion 10.64 9.70 7 144743 332 79599306
Angina bullosa haemorrhagica 10.63 9.70 6 144744 215 79599423
Suicidal ideation 10.62 9.70 88 144662 76252 79523386
Musculoskeletal disorder 10.62 9.70 14 144736 21434 79578204
Mucopolysaccharidosis II 10.59 9.70 3 144747 15 79599623
Photophobia 10.58 9.70 13 144737 20515 79579123
Blood parathyroid hormone decreased 10.57 9.70 3 144747 10533 79589105
Anxiety 10.56 9.70 552 144198 247960 79351678
Lupus-like syndrome 10.56 9.70 6 144744 13851 79585787
Pneumonia legionella 10.55 9.70 19 144731 2903 79596735
Cellulitis 10.55 9.70 137 144613 108923 79490715
Pulmonary cavitation 10.55 9.70 14 144736 1642 79597996
Vascular parkinsonism 10.54 9.70 5 144745 124 79599514
Infection reactivation 10.53 9.70 18 144732 2639 79596999
Dysbiosis 10.50 9.70 12 144738 1207 79598431
Urinary retention 10.50 9.70 60 144690 56570 79543068
Mycobacterium abscessus infection 10.48 9.70 12 144738 1210 79598428
Opportunistic infection 10.42 9.70 19 144731 2931 79596707
Ventricular fibrillation 10.41 9.70 96 144654 31830 79567808
Bronchial anastomosis complication 10.40 9.70 4 144746 58 79599580
Forced expiratory volume increased 10.40 9.70 4 144746 58 79599580
Cheilitis 10.35 9.70 27 144723 5314 79594324
Vascular access site pain 10.32 9.70 5 144745 130 79599508
Wrong dose 10.30 9.70 14 144736 1680 79597958
Glucose-6-phosphate dehydrogenase deficiency 10.29 9.70 7 144743 351 79599287
Abortion spontaneous 10.28 9.70 90 144660 29417 79570221
Enanthema 10.24 9.70 10 144740 839 79598799
Respiratory gas exchange disorder 10.22 9.70 10 144740 841 79598797
Post transplant lymphoproliferative disorder 10.21 9.70 4 144746 11460 79588178
Myopia 10.17 9.70 15 144735 1941 79597697
Sinusitis 10.16 9.70 443 144307 195058 79404580
Conjunctivochalasis 10.14 9.70 3 144747 18 79599620
Interstitial granulomatous dermatitis 10.13 9.70 6 144744 236 79599402
Kidney transplant rejection 10.13 9.70 3 144747 10243 79589395
Haematotoxicity 10.10 9.70 8 144742 15511 79584127
Mediastinal shift 10.09 9.70 4 144746 63 79599575
Eosinophilic pneumonia chronic 10.07 9.70 8 144742 510 79599128
Virologic failure 10.06 9.70 23 144727 4168 79595470
Intentional self-injury 10.05 9.70 28 144722 32391 79567247
Flushing 10.03 9.70 107 144643 88161 79511477
Product use issue 10.02 9.70 297 144453 209525 79390113
Ureteric perforation 10.00 9.70 3 144747 19 79599619
Pneumocystis test positive 10.00 9.70 3 144747 19 79599619
Stridor 9.99 9.70 27 144723 5426 79594212
Ectopic pregnancy 9.99 9.70 14 144736 1729 79597909
Walking aid user 9.98 9.70 3 144747 10145 79589493
Laryngeal pain 9.96 9.70 29 144721 6085 79593553
Interleukin-2 receptor increased 9.95 9.70 6 144744 244 79599394
Diabetes mellitus inadequate control 9.94 9.70 18 144732 24246 79575392
Severe acute respiratory syndrome 9.92 9.70 5 144745 142 79599496
Eye swelling 9.89 9.70 82 144668 26386 79573252
Squamous cell carcinoma of skin 9.88 9.70 51 144699 13982 79585656
Poor venous access 9.88 9.70 11 144739 18138 79581500
Blood uric acid increased 9.87 9.70 6 144744 13354 79586284
Delusion of parasitosis 9.87 9.70 3 144747 20 79599618
Syncope 9.87 9.70 249 144501 179200 79420438
Appendicitis 9.86 9.70 14 144736 20780 79578858
Thermal burn 9.83 9.70 32 144718 7128 79592510
Eosinophilic granulomatosis with polyangiitis 9.81 9.70 21 144729 3639 79595999
Graft infection 9.77 9.70 9 144741 702 79598936
Hyperaesthesia 9.74 9.70 5 144745 12217 79587421

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 J01RA16 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
Haemophilus Influenzae Acute Otitis Media indication 19021002
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
Moraxella Catarrhalis Acute Otitis Media indication 703469002
Skin and Skin Structure Streptococcus Agalactiae Infection indication
Pelvic Inflammatory Disease with Neisseria Gonorrhea indication
Chlamydia Cervicitis indication
Moraxella Catarrhalis Pneumonia indication
Pneumococcal Acute Otitis Media indication
Legionella Pneumophila Pneumonia 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
Inflammatory Disease of Female Pelvic Organs off-label use
Sexual Transmitted Disease Exposure from Sexual Assault off-label use
Prevention of Bacterial Endocarditis 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
Canalicular multispecific organic anion transporter 1 Transporter IC50 4.16 WOMBAT-PK
Motilin receptor GPCR AGONIST EC50 5.50 IUPHAR
Taste receptor type 2 member 4 GPCR AGONIST EC50 4.13 IUPHAR
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

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
387531004 SNOMEDCT_US
391805000 SNOMEDCT_US
734459003 SNOMEDCT_US
785687007 SNOMEDCT_US
96034006 SNOMEDCT_US
6197 INN_ID
4020019 VANDF
4020964 VANDF
JTE4MNN1MD UNII
003635 NDDF

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