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

Stem definitionDrug idCAS RN
atropine derivatives 2677 186691-13-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • tiotropium bromide hydrate
  • tiotropium
  • respimat
  • tiotropium bromide
  • tiotropium bromide monohydrate
  • spiriva
  • tiotropiumbromide
A scopolamine derivative and CHOLINERGIC ANTAGONIST that functions as a BRONCHODILATOR AGENT. It is used in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
  • Molecular weight: 392.51
  • Formula: C19H22NO4S2
  • CLOGP: -1.91
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 59.06
  • ALOGS: -4.44
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mcg Inhal.powder
5 mcg Inhal.solution

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 74 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.00 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 2.50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 32 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 12.60 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.28 % Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 30, 2004 FDA BOEHRINGER INGELHEIM

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
Incorrect route of product administration 6957.90 11.69 2455 124239 24997 63337331
Asthma 3325.81 11.69 2430 124264 125131 63237197
Dyspnoea 1950.79 11.69 4145 122549 657168 62705160
Wheezing 1880.59 11.69 1543 125151 94052 63268276
Obstructive airways disorder 1540.63 11.69 775 125919 19924 63342404
Chronic obstructive pulmonary disease 1234.03 11.69 1013 125681 61673 63300655
Sleep disorder due to a general medical condition 979.69 11.69 481 126213 11707 63350621
Full blood count abnormal 935.65 11.69 653 126041 31064 63331264
Productive cough 915.27 11.69 858 125836 62350 63299978
Cough 891.79 11.69 1866 124828 290877 63071451
Forced expiratory volume decreased 709.40 11.69 293 126401 4675 63357653
Sputum discoloured 655.91 11.69 408 126286 15939 63346389
Product quality issue 635.90 11.69 546 126148 35319 63327009
Pneumonia 540.56 11.69 2065 124629 454702 62907626
Sedation complication 487.39 11.69 318 126376 13504 63348824
Creatinine renal clearance decreased 462.72 11.69 328 126366 15980 63346348
Therapeutic product effect incomplete 435.35 11.69 844 125850 124212 63238116
Orthostatic hypotension 383.63 11.69 415 126279 35745 63326583
Chest discomfort 380.02 11.69 740 125954 109229 63253099
Contraindicated product administered 369.53 11.69 15 126679 217633 63144695
Sedation 336.26 11.69 401 126293 38408 63323920
Blood calcium decreased 335.31 11.69 334 126360 26117 63336211
Synovitis 323.76 11.69 11 126683 186907 63175421
Loss of personal independence in daily activities 319.56 11.69 641 126053 96649 63265679
Systemic lupus erythematosus 308.54 11.69 30 126664 208888 63153440
Treatment failure 290.23 11.69 30 126664 199013 63163315
Dyspnoea exertional 289.81 11.69 469 126225 59833 63302495
Off label use 283.41 11.69 576 126118 673886 62688442
Drug intolerance 283.09 11.69 131 126563 308530 63053798
Middle insomnia 279.65 11.69 219 126475 12424 63349904
Balance disorder 267.42 11.69 548 126146 83874 63278454
Hand deformity 267.24 11.69 12 126682 159445 63202883
Arthropathy 262.30 11.69 72 126622 234720 63127608
Cognitive disorder 261.29 11.69 429 126265 55386 63306942
Maternal exposure during pregnancy 260.28 11.69 60 126634 220002 63142326
Completed suicide 257.93 11.69 7 126687 145666 63216662
Dysphonia 235.16 11.69 375 126319 47239 63315089
Alopecia 234.04 11.69 198 126496 337338 63024990
Bronchitis 231.54 11.69 659 126035 124276 63238052
Blood immunoglobulin E increased 231.43 11.69 125 126569 3724 63358604
Eosinophil count increased 226.07 11.69 182 126512 10746 63351582
Pulmonary mass 225.17 11.69 251 126443 22345 63339983
Glossodynia 221.23 11.69 44 126650 178832 63183496
Pericarditis 220.14 11.69 10 126684 131569 63230759
Reversible airways obstruction 214.41 11.69 94 126600 1748 63360580
Abdominal discomfort 214.27 11.69 195 126499 320690 63041638
Respiratory tract infection 208.00 11.69 329 126365 41154 63321174
Exposure during pregnancy 203.74 11.69 33 126661 155514 63206814
Joint swelling 201.61 11.69 214 126480 327452 63034876
Upper-airway cough syndrome 198.55 11.69 172 126522 11246 63351082
Depressed level of consciousness 197.76 11.69 404 126290 61674 63300654
Anti-cyclic citrullinated peptide antibody positive 190.66 11.69 10 126684 116202 63246126
Nasal congestion 190.19 11.69 411 126283 65249 63297079
Rheumatoid arthritis 188.30 11.69 139 126555 253680 63108648
Lung neoplasm malignant 186.94 11.69 213 126481 19420 63342908
Nasal polyps 172.51 11.69 122 126572 5917 63356411
Hepatic enzyme increased 171.67 11.69 95 126599 202233 63160095
Total lung capacity increased 170.29 11.69 86 126608 2224 63360104
Wound 169.72 11.69 57 126637 163206 63199122
Asthmatic crisis 162.10 11.69 77 126617 1736 63360592
Vital capacity decreased 159.44 11.69 75 126619 1653 63360675
Infusion related reaction 159.32 11.69 153 126541 245368 63116960
Bronchial secretion retention 158.25 11.69 87 126607 2686 63359642
Bronchiectasis 156.87 11.69 177 126517 15965 63346363
Forced vital capacity decreased 155.25 11.69 64 126630 1015 63361313
Secretion discharge 152.31 11.69 153 126541 12078 63350250
Therapeutic product effect decreased 149.55 11.69 101 126593 193086 63169242
Rales 149.32 11.69 154 126540 12543 63349785
Throat clearing 146.67 11.69 79 126615 2340 63359988
Discomfort 138.50 11.69 81 126613 167293 63195035
Emphysema 138.37 11.69 138 126556 10800 63351528
Breath sounds abnormal 134.33 11.69 136 126558 10837 63351491
Arthralgia 133.04 11.69 635 126059 569075 62793253
Helicobacter infection 132.57 11.69 15 126679 92770 63269558
Restrictive pulmonary disease 127.00 11.69 65 126629 1730 63360598
Asthma-chronic obstructive pulmonary disease overlap syndrome 126.90 11.69 68 126626 1993 63360335
Swelling 126.73 11.69 222 126472 275156 63087172
Hypoventilation 122.01 11.69 90 126604 4664 63357664
Neutropenia 121.93 11.69 102 126592 174903 63187425
Sputum culture positive 120.95 11.69 67 126627 2100 63360228
Nasal obstruction 120.49 11.69 62 126632 1669 63360659
Respiratory tract congestion 119.19 11.69 162 126532 17670 63344658
Eosinophilia 118.94 11.69 184 126510 22572 63339756
Folliculitis 118.72 11.69 5 126689 70312 63292016
Peak expiratory flow rate decreased 113.77 11.69 44 126650 585 63361743
Eosinophilic granulomatosis with polyangiitis 112.11 11.69 64 126630 2128 63360200
Bronchial wall thickening 111.06 11.69 56 126638 1443 63360885
Influenza 108.99 11.69 468 126226 108254 63254074
Total lung capacity decreased 107.01 11.69 62 126632 2121 63360207
Product use issue 106.76 11.69 172 126522 220348 63141980
Psoriatic arthropathy 104.11 11.69 27 126667 91493 63270835
Intentional overdose 103.43 11.69 13 126681 74139 63288189
Irritable bowel syndrome 102.40 11.69 20 126674 82392 63279936
Haemoptysis 101.14 11.69 195 126499 28531 63333797
Rash 100.65 11.69 681 126013 560190 62802138
Lung diffusion test abnormal 99.48 11.69 34 126660 309 63362019
Impaired healing 99.44 11.69 40 126654 102502 63259826
Eosinophil count abnormal 98.82 11.69 39 126655 549 63361779
Fall 98.23 11.69 1205 125489 391129 62971199
Blister 97.59 11.69 70 126624 129744 63232584
Intentional product use issue 97.41 11.69 68 126626 127824 63234504
Musculoskeletal stiffness 97.09 11.69 136 126558 184482 63177846
Respiration abnormal 96.38 11.69 89 126605 6328 63356000
Bronchopulmonary aspergillosis allergic 94.71 11.69 58 126636 2200 63360128
Constipation 94.27 11.69 769 125925 224174 63138154
Rhinitis allergic 93.13 11.69 116 126578 11611 63350717
Pulmonary function test decreased 93.01 11.69 71 126623 3876 63358452
Febrile neutropenia 91.52 11.69 62 126632 118387 63243941
Gastrooesophageal reflux disease 90 11.69 404 126290 95235 63267093
Drug ineffective 89.73 11.69 1508 125186 1043257 62319071
Sleep apnoea syndrome 89.68 11.69 187 126507 28946 63333382
Gastrointestinal disorder 89.55 11.69 78 126616 131161 63231167
Sensitivity to weather change 89.14 11.69 90 126604 7147 63355181
Rhinitis 87.98 11.69 111 126583 11255 63351073
Lung opacity 85.89 11.69 62 126632 3106 63359222
Lung diffusion test decreased 85.74 11.69 37 126657 661 63361667
White blood cell count decreased 85.23 11.69 91 126603 139013 63223315
Prolonged expiration 84.31 11.69 42 126652 1054 63361274
Vocal cord dysfunction 83.42 11.69 34 126660 523 63361805
Upper respiratory tract infection 81.30 11.69 352 126342 81695 63280633
Thrombocytopenia 80.82 11.69 110 126584 151047 63211281
Malaise 80.12 11.69 1219 125475 414735 62947593
Impaired quality of life 79.93 11.69 117 126577 13666 63348662
Multiple allergies 79.81 11.69 117 126577 13685 63348643
Mobility decreased 79.79 11.69 463 126231 120696 63241632
Respiratory rate increased 79.36 11.69 116 126578 13532 63348796
C-reactive protein abnormal 78.75 11.69 3 126691 46093 63316235
Oropharyngeal pain 78.55 11.69 385 126309 94102 63268226
Diarrhoea 77.07 11.69 987 125707 714379 62647949
Bronchospasm 77.04 11.69 130 126564 17150 63345178
Heart rate increased 76.21 11.69 381 126313 93857 63268471
Lung disorder 75.14 11.69 284 126410 61977 63300351
Oxygen saturation decreased 73.67 11.69 361 126333 88224 63274104
Dust allergy 72.58 11.69 33 126661 671 63361657
Cardiac murmur 72.34 11.69 115 126579 14437 63347891
Drug hypersensitivity 71.31 11.69 348 126346 310339 63051989
Liver injury 70.48 11.69 17 126677 60503 63301825
Blood cholesterol increased 70.28 11.69 51 126643 93981 63268347
Choking 67.92 11.69 91 126603 9788 63352540
Drug abuse 67.56 11.69 30 126664 72488 63289840
Blood pressure systolic increased 67.27 11.69 228 126466 47169 63315159
Lung hyperinflation 66.74 11.69 38 126656 1257 63361071
Hypercapnia 64.09 11.69 66 126628 5365 63356963
Hyper IgE syndrome 62.53 11.69 27 126667 483 63361845
Factor V Leiden mutation 59.66 11.69 21 126673 210 63362118
Respiratory gas exchange disorder 58.60 11.69 24 126670 374 63361954
Pregnancy 57.88 11.69 4 126690 36832 63325496
Pancytopenia 57.61 11.69 65 126629 96868 63265460
Sarcoidosis 57.43 11.69 71 126623 7051 63355277
Infective exacerbation of chronic obstructive airways disease 57.14 11.69 34 126660 1223 63361105
Seasonal allergy 57.07 11.69 128 126566 20822 63341506
Asthma exercise induced 56.65 11.69 22 126672 296 63362032
Platelet count decreased 55.75 11.69 91 126603 116031 63246297
Spirometry abnormal 55.04 11.69 20 126674 221 63362107
Smoke sensitivity 54.95 11.69 24 126670 442 63361886
Aphonia 54.88 11.69 83 126611 9980 63352348
Oesophageal spasm 54.20 11.69 47 126647 3076 63359252
Sinus disorder 53.93 11.69 138 126556 24415 63337913
Blood test abnormal 53.67 11.69 105 126589 15524 63346804
Rubber sensitivity 52.89 11.69 41 126653 2290 63360038
Rib deformity 52.19 11.69 20 126674 259 63362069
Nausea 52.03 11.69 1304 125390 853167 62509161
Lower respiratory tract infection 51.46 11.69 445 126249 131862 63230466
Pain 51.28 11.69 1108 125586 739520 62622808
Malignant neoplasm progression 51.10 11.69 53 126641 82068 63280260
Broncholithiasis 50.44 11.69 19 126675 234 63362094
Respiratory disorder 50.27 11.69 182 126512 38900 63323428
Allergy to animal 49.71 11.69 31 126663 1215 63361113
Increased upper airway secretion 49.55 11.69 48 126646 3624 63358704
Therapy non-responder 49.51 11.69 47 126647 75854 63286474
Hypoxia 49.22 11.69 243 126451 59549 63302779
Lymph node calcification 48.81 11.69 20 126674 312 63362016
Skin candida 48.58 11.69 34 126660 1621 63360707
Seizure 48.27 11.69 122 126572 132512 63229816
Alanine aminotransferase increased 48.25 11.69 83 126611 103687 63258641
Suicide attempt 48.24 11.69 31 126663 60887 63301441
Abortion spontaneous 48.10 11.69 17 126677 47178 63315150
Knee arthroplasty 48.06 11.69 24 126670 54182 63308146
Disease progression 47.77 11.69 109 126585 122649 63239679
Hip arthroplasty 47.14 11.69 18 126676 47628 63314700
Humidity intolerance 47.14 11.69 20 126674 342 63361986
Mycobacterium avium complex infection 46.71 11.69 43 126651 3045 63359283
Acute respiratory failure 46.41 11.69 163 126531 34322 63328006
Sputum purulent 45.79 11.69 28 126666 1059 63361269
Product physical issue 45.67 11.69 53 126641 4927 63357401
Pulmonary function test abnormal 45.51 11.69 34 126660 1796 63360532
Heart sounds 45.43 11.69 27 126667 969 63361359
Perfume sensitivity 45.23 11.69 25 126669 780 63361548
C-reactive protein increased 44.73 11.69 75 126619 94632 63267696
Oesophageal pain 43.71 11.69 45 126649 3656 63358672
Chest pain 43.44 11.69 638 126056 215321 63147007
Lower respiratory tract congestion 43.29 11.69 40 126654 2846 63359482
Hypotension 42.79 11.69 773 125921 271831 63090497
Bronchitis chronic 42.75 11.69 48 126646 4305 63358023
Eczema 42.06 11.69 151 126543 32140 63330188
Drug-induced liver injury 41.83 11.69 14 126680 40208 63322120
Degenerative bone disease 41.75 11.69 15 126679 160 63362168
Paroxysmal extreme pain disorder 41.50 11.69 13 126681 87 63362241
Red blood cell sedimentation rate increased 41.27 11.69 18 126676 43964 63318364
Idiopathic intracranial hypertension 40.85 11.69 39 126655 2892 63359436
Status asthmaticus 39.92 11.69 24 126670 880 63361448
Multiple sclerosis relapse 39.31 11.69 24 126670 48454 63313874
Occupational asthma 39.25 11.69 14 126680 146 63362182
Throat irritation 39.19 11.69 164 126530 37483 63324845
Throat tightness 39.15 11.69 124 126570 24763 63337565
Oedema peripheral 38.94 11.69 562 126132 188949 63173379
Stomatitis 38.78 11.69 144 126550 138581 63223747
Frustration tolerance decreased 38.62 11.69 58 126636 6930 63355398
Laryngeal stenosis 38.48 11.69 25 126669 1053 63361275
Rhinorrhoea 38.31 11.69 243 126451 65334 63296994
Respiratory failure 38.25 11.69 340 126354 101518 63260810
Aspartate aminotransferase increased 37.74 11.69 77 126617 90200 63272128
Adverse event 37.28 11.69 48 126646 67511 63294817
Condition aggravated 37.08 11.69 572 126122 401645 62960683
Chronic respiratory disease 36.90 11.69 14 126680 176 63362152
Cholestasis 36.86 11.69 7 126687 29427 63332901
Coma 36.27 11.69 45 126649 64319 63298009
Viral infection 36.07 11.69 154 126540 35509 63326819
Blood pressure increased 35.87 11.69 487 126207 161575 63200753
Confusional arousal 35.54 11.69 14 126680 196 63362132
Fatigue 35.41 11.69 1432 125262 886596 62475732
Liver disorder 35.30 11.69 33 126661 53654 63308674
Vision blurred 35.11 11.69 308 126386 91616 63270712
Nasal discharge discolouration 35.08 11.69 32 126662 2239 63360089
Psoriasis 34.82 11.69 76 126618 86881 63275447
Blood calcium increased 34.79 11.69 65 126629 9285 63353043
Bronchomalacia 34.19 11.69 14 126680 218 63362110
Pneumothorax spontaneous 33.90 11.69 21 126673 813 63361515
Drug ineffective for unapproved indication 33.48 11.69 13 126681 34050 63328278
Expiratory reserve volume decreased 33.39 11.69 9 126685 32 63362296
Nasal mucosal disorder 33.23 11.69 17 126677 452 63361876
Bronchial obstruction 33.09 11.69 26 126668 1481 63360847
Carcinoid tumour pulmonary 32.92 11.69 17 126677 461 63361867
Joint range of motion decreased 32.50 11.69 12 126682 32416 63329912
Intentional self-injury 32.40 11.69 6 126688 25681 63336647
Product use in unapproved indication 32.19 11.69 217 126477 178863 63183465
Nasopharyngitis 31.84 11.69 697 125997 253560 63108768
Post procedural hypothyroidism 31.70 11.69 14 126680 265 63362063
Cardio-respiratory arrest 31.66 11.69 44 126650 59915 63302413
Painful respiration 31.45 11.69 33 126661 2741 63359587
Neurosensory hypoacusis 30.93 11.69 13 126681 217 63362111
Prescribed overdose 30.46 11.69 15 126679 34138 63328190
Drug reaction with eosinophilia and systemic symptoms 29.97 11.69 15 126679 33821 63328507
Chest X-ray abnormal 29.90 11.69 41 126653 4508 63357820
Hypoaesthesia 29.79 11.69 205 126489 168188 63194140
Forced expiratory flow decreased 29.74 11.69 10 126684 86 63362242
Neoplasm progression 29.58 11.69 18 126676 36410 63325918
Increased bronchial secretion 29.49 11.69 26 126668 1740 63360588
Neuropathy peripheral 29.21 11.69 122 126572 113545 63248783
Dry throat 28.97 11.69 50 126644 6715 63355613
Paraesthesia 28.81 11.69 189 126505 156777 63205551
Respiratory distress 28.66 11.69 139 126555 33812 63328516
Multiple organ dysfunction syndrome 28.63 11.69 43 126651 56709 63305619
Decreased bronchial secretion 28.51 11.69 9 126685 62 63362266
Mite allergy 27.80 11.69 17 126677 643 63361685
Premature delivery 27.46 11.69 13 126681 30268 63332060
Leukopenia 27.41 11.69 72 126622 77218 63285110
CFTR gene mutation 27.08 11.69 10 126684 116 63362212
Weight decreased 26.89 11.69 733 125961 276065 63086263
Oesophageal dilatation 26.87 11.69 14 126680 387 63361941
Dry mouth 26.75 11.69 255 126439 77608 63284720
Hepatic function abnormal 26.65 11.69 21 126673 37121 63325207
Body temperature decreased 26.44 11.69 95 126599 20224 63342104
Intentional product misuse 26.28 11.69 51 126643 60866 63301462
Cytomegalovirus infection 26.20 11.69 5 126689 20947 63341381
Polymyalgia rheumatica 26.18 11.69 35 126659 3756 63358572
HIV infection 26.16 11.69 14 126680 409 63361919
Infection 26.10 11.69 312 126382 228861 63133467
Septic shock 26.04 11.69 59 126635 66570 63295758
Palmar-plantar erythrodysaesthesia syndrome 25.77 11.69 7 126687 23008 63339320
Pneumonia viral 25.73 11.69 52 126642 7870 63354458
Multiple drug therapy 25.70 11.69 34 126660 3612 63358716
Muscle spasticity 25.61 11.69 6 126688 21788 63340540
Glossitis 25.30 11.69 31 126663 3051 63359277
Diabetes mellitus 25.07 11.69 194 126500 55616 63306712
Peak expiratory flow rate abnormal 25.05 11.69 9 126685 96 63362232
Rhonchi 24.60 11.69 28 126666 2548 63359780
Perineal fistula 24.40 11.69 7 126687 33 63362295
Breath sounds 24.33 11.69 9 126685 105 63362223
Inflammation 23.91 11.69 84 126610 82189 63280139
Total lung capacity abnormal 23.67 11.69 8 126686 70 63362258
Night sweats 23.65 11.69 38 126656 48776 63313552
FEV1/FVC ratio decreased 23.59 11.69 9 126685 115 63362213
Exposure to allergen 23.49 11.69 12 126682 318 63362010
Hypersensitivity 23.41 11.69 427 126267 292258 63070070
Device dislocation 23.37 11.69 11 126683 25694 63336634
Injury 23.21 11.69 72 126622 73175 63289153
Peripheral swelling 23.19 11.69 382 126312 265560 63096768
Lymphocyte count decreased 23.14 11.69 16 126678 30241 63332087
Aspirin-exacerbated respiratory disease 23.09 11.69 17 126677 878 63361450
Bone marrow failure 23.06 11.69 15 126679 29275 63333053
Increased viscosity of bronchial secretion 23.05 11.69 12 126682 331 63361997
Functional residual capacity decreased 23.00 11.69 8 126686 77 63362251
Schizophrenia 22.96 11.69 57 126637 9895 63352433
Forced expiratory volume abnormal 22.91 11.69 8 126686 78 63362250
Sputum culture 22.57 11.69 11 126683 263 63362065
Illness 22.29 11.69 171 126523 48888 63313440
Dyslipidaemia 22.22 11.69 47 126647 7346 63354982
Pharyngeal oedema 22.16 11.69 69 126625 13652 63348676
Drug resistance 22.13 11.69 9 126685 22924 63339404
Functional residual capacity increased 21.97 11.69 8 126686 89 63362239
Foetal exposure during pregnancy 21.78 11.69 19 126675 31943 63330385
Acute myeloid leukaemia 21.64 11.69 4 126690 17143 63345185
Hepatocellular injury 21.58 11.69 14 126680 27367 63334961
Electrocardiogram QT prolonged 21.46 11.69 55 126639 59475 63302853
Respiratory depression 21.26 11.69 68 126626 13647 63348681
Depressive symptom 21.19 11.69 33 126661 4069 63358259
Osteoarthritis 21.13 11.69 108 126586 95235 63267093
Hypomania 21.10 11.69 42 126652 6288 63356040
Prescribed underdose 21.03 11.69 17 126677 29672 63332656
Foot deformity 20.94 11.69 15 126679 27838 63334490
Laboratory test abnormal 20.89 11.69 14 126680 26898 63335430
Lip dry 20.88 11.69 3 126691 15467 63346861
Blood creatine phosphokinase increased 20.84 11.69 18 126676 30412 63331916
Aspiration 20.81 11.69 58 126636 10793 63351535
Pulmonary pain 20.78 11.69 30 126664 3460 63358868
Hepatic cytolysis 20.77 11.69 3 126691 15404 63346924
Neutrophil count decreased 20.42 11.69 52 126642 56354 63305974
Nocturnal dyspnoea 20.40 11.69 18 126676 1206 63361122
Plasma cell myeloma 20.34 11.69 25 126669 35880 63326448
Lipohypertrophy 20.31 11.69 14 126680 651 63361677
Deep vein thrombosis 20.27 11.69 92 126602 83708 63278620
Disturbance in attention 20.18 11.69 28 126666 38161 63324167
Drug withdrawal syndrome 19.99 11.69 15 126679 27179 63335149
Oral candidiasis 19.72 11.69 94 126600 22704 63339624
Drug eruption 19.62 11.69 17 126677 28677 63333651
Skin ulcer 19.48 11.69 35 126659 43010 63319318
Blood immunoglobulin E decreased 19.21 11.69 7 126687 78 63362250
Confusional state 19.16 11.69 344 126350 236036 63126292
Cerebral infarction 19.13 11.69 12 126682 23881 63338447
Swollen tongue 19.12 11.69 127 126567 34673 63327655
Hypoacusis 19.05 11.69 97 126597 24054 63338274
Mononeuropathy multiplex 19.01 11.69 10 126684 282 63362046
Female sterilisation 18.91 11.69 13 126681 602 63361726
Nasal oedema 18.88 11.69 19 126675 1503 63360825
Metastases to liver 18.75 11.69 12 126682 23627 63338701
Peripheral venous disease 18.71 11.69 4 126690 15473 63346855
Ageusia 18.56 11.69 65 126629 13663 63348665
Eye infection bacterial 18.55 11.69 9 126685 213 63362115
Atrial flutter 18.51 11.69 52 126642 9720 63352608
Chronic sinusitis 18.41 11.69 62 126632 12781 63349547
Lupus-like syndrome 18.40 11.69 4 126690 15291 63347037
Chronic respiratory failure 18.32 11.69 21 126673 1926 63360402
Foetal malnutrition 18.04 11.69 7 126687 94 63362234
Sinus polyp degeneration 18.01 11.69 6 126688 50 63362278
Abdominal pain 17.95 11.69 447 126247 293009 63069319
Croup infectious 17.86 11.69 12 126682 535 63361793
Encephalopathy 17.84 11.69 31 126663 38589 63323739
Fungal endocarditis 17.77 11.69 9 126685 234 63362094
Anaphylactic reaction 17.76 11.69 206 126488 65894 63296434
Exercise tolerance decreased 17.76 11.69 36 126658 5461 63356867
Hepatic cirrhosis 17.72 11.69 14 126680 24720 63337608
Crystal arthropathy 17.69 11.69 10 126684 326 63362002
Caesarean section 17.59 11.69 6 126688 17026 63345302
Forced expiratory volume increased 17.53 11.69 5 126689 23 63362305
Urinary retention 17.52 11.69 112 126582 30189 63332139
Social problem 17.42 11.69 14 126680 824 63361504
Cardiogenic shock 17.37 11.69 7 126687 17925 63344403
Laryngectomy 17.35 11.69 5 126689 24 63362304
Rib fracture 17.30 11.69 90 126604 22507 63339821
Lymphoedema 17.25 11.69 57 126637 11635 63350693
Shock 17.17 11.69 13 126681 23450 63338878
Candida infection 17.14 11.69 106 126588 28245 63334083
Heavy menstrual bleeding 17.11 11.69 7 126687 17766 63344562
Mouth injury 17.03 11.69 15 126679 1002 63361326
Carbon dioxide increased 17.01 11.69 17 126677 1333 63360995
Injection site reaction 16.84 11.69 60 126634 58464 63303864
Vaginal haemorrhage 16.80 11.69 18 126676 27469 63334859
Ascites 16.80 11.69 35 126659 40693 63321635
Amnesia 16.66 11.69 56 126638 55529 63306799
Tooth disorder 16.59 11.69 19 126675 28138 63334190
Acute hepatic failure 16.42 11.69 8 126686 18319 63344009
Wrist fracture 16.40 11.69 62 126632 13525 63348803
Status epilepticus 16.38 11.69 5 126689 15228 63347100
Rash maculo-papular 16.25 11.69 24 126670 31872 63330456
Haemoglobin decreased 16.20 11.69 199 126495 145286 63217042
Pulmonary thrombosis 16.18 11.69 46 126648 8656 63353672
Vomiting 16.15 11.69 933 125761 558684 62803644
Drug level increased 16.13 11.69 13 126681 22723 63339605
Dyspnoea at rest 15.99 11.69 29 126665 4050 63358278
Pulmonary congestion 15.93 11.69 73 126621 17345 63344983
Immune-mediated pancreatitis 15.78 11.69 7 126687 134 63362194
Hepatitis 15.74 11.69 35 126659 39753 63322575
Product prescribing error 15.71 11.69 98 126596 26191 63336137
Occult blood 15.69 11.69 16 126678 1285 63361043
Sciatica 15.45 11.69 28 126666 34296 63328032
Pyrexia 15.32 11.69 775 125919 469703 62892625
Polycystic ovaries 15.30 11.69 30 126664 4441 63357887
Nervousness 15.22 11.69 110 126584 30869 63331459
Toxic epidermal necrolysis 15.03 11.69 17 126677 25317 63337011
Respiratory tract irritation 14.98 11.69 10 126684 441 63361887
Inhalation therapy 14.98 11.69 5 126689 42 63362286
Mucosal inflammation 14.95 11.69 46 126648 46882 63315446
Colitis ulcerative 14.95 11.69 18 126676 26073 63336255
Interstitial lung disease 14.95 11.69 68 126626 61840 63300488
Jaundice cholestatic 14.89 11.69 40 126654 7284 63355044
Full blood count decreased 14.86 11.69 18 126676 26006 63336322
Cytokine release syndrome 14.85 11.69 5 126689 14309 63348019
Acute respiratory distress syndrome 14.85 11.69 15 126679 23519 63338809
Injection site erythema 14.82 11.69 101 126593 83073 63279255
Magnesium metabolism disorder 14.77 11.69 5 126689 44 63362284
Musculoskeletal discomfort 14.76 11.69 73 126621 17894 63344434
Bronchospasm paradoxical 14.74 11.69 6 126688 92 63362236
Respiratory tract inflammation 14.53 11.69 11 126683 593 63361735
Premature baby 14.53 11.69 12 126682 20723 63341605
Muscular weakness 14.52 11.69 165 126529 122188 63240140
Dyskinesia 14.50 11.69 26 126668 31976 63330352
Cardiac failure congestive 14.43 11.69 262 126432 92171 63270157
Blood lactate dehydrogenase increased 14.28 11.69 15 126679 23101 63339227
Exostosis 14.26 11.69 9 126685 17853 63344475
Adenocarcinoma 14.23 11.69 23 126671 2927 63359401
Frequent bowel movements 14.16 11.69 15 126679 23007 63339321
Overdose 14.13 11.69 154 126540 114924 63247404
Cytopenia 14.02 11.69 3 126691 11598 63350730
Ear discomfort 13.94 11.69 41 126653 7865 63354463
Aphasia 13.91 11.69 28 126666 32972 63329356
Appetite disorder 13.91 11.69 39 126655 7282 63355046
Muscle rigidity 13.85 11.69 3 126691 11497 63350831
Colitis 13.80 11.69 50 126644 48478 63313850
Sinus congestion 13.75 11.69 72 126622 18051 63344277
Hypophosphataemia 13.72 11.69 3 126691 11423 63350905
Enterobiasis 13.70 11.69 5 126689 56 63362272
Impaired work ability 13.68 11.69 9 126685 17466 63344862
Premature labour 13.63 11.69 4 126690 12500 63349828
Bacterial disease carrier 13.63 11.69 15 126679 1316 63361012
Adverse drug reaction 13.62 11.69 98 126596 79616 63282712
Caffeine allergy 13.59 11.69 4 126690 21 63362307
Right ventricular systolic pressure 13.58 11.69 3 126691 3 63362325
Arthritis 13.50 11.69 157 126537 115764 63246564
Infective aneurysm 13.42 11.69 9 126685 400 63361928
Pulmonary arterial hypertension 13.39 11.69 84 126610 22493 63339835
Skin lesion 13.36 11.69 106 126588 30615 63331713
Monocytopenia 13.32 11.69 5 126689 61 63362267
Forced vital capacity abnormal 13.28 11.69 4 126690 23 63362305
Serotonin syndrome 13.27 11.69 23 126671 28659 63333669
Brain hypoxia 13.26 11.69 10 126684 536 63361792
Rheumatoid nodule 13.21 11.69 9 126685 17146 63345182
Peritonitis 13.21 11.69 9 126685 17145 63345183
Musculoskeletal disorder 13.21 11.69 13 126681 20631 63341697
Grip strength decreased 13.18 11.69 15 126679 22272 63340056
Myocardial infarction 13.17 11.69 276 126418 99617 63262711
Pneumonia aspiration 13.16 11.69 31 126663 34509 63327819
Metabolic acidosis 13.10 11.69 46 126648 45023 63317305
Blood alkaline phosphatase increased 13.07 11.69 43 126651 42924 63319404
Pancreatitis 13.00 11.69 52 126642 49003 63313325
Sepsis 12.99 11.69 221 126473 152902 63209426
Complication associated with device 12.95 11.69 9 126685 16969 63345359
Osteomyelitis 12.85 11.69 20 126674 26000 63336328
Lung diffusion disorder 12.69 11.69 5 126689 70 63362258
Overweight 12.64 11.69 25 126669 3726 63358602
Chronic gastrointestinal bleeding 12.56 11.69 6 126688 137 63362191
Coronavirus test positive 12.50 11.69 11 126683 734 63361594
Scratch 12.50 11.69 35 126659 6530 63355798
Oxygen saturation abnormal 12.47 11.69 24 126670 3505 63358823
Hallucination, auditory 12.43 11.69 5 126689 12819 63349509
Sputum retention 12.39 11.69 10 126684 592 63361736
Poisoning 12.24 11.69 6 126688 13694 63348634
Haematocrit decreased 12.23 11.69 39 126655 39301 63323027
Airway remodelling 12.20 11.69 5 126689 78 63362250
Fibromuscular dysplasia 12.20 11.69 7 126687 235 63362093
Pain of skin 12.18 11.69 4 126690 11630 63350698
Ejection fraction decreased 12.18 11.69 16 126678 22316 63340012
Bone density decreased 12.17 11.69 7 126687 14605 63347723
Aspergillus test positive 12.16 11.69 8 126686 344 63361984
Anaemia 12.07 11.69 471 126223 292959 63069369
Pulmonary eosinophilia 12.06 11.69 8 126686 349 63361979
Synovial cyst 12.01 11.69 3 126691 10430 63351898
General physical health deterioration 11.98 11.69 308 126386 201094 63161234
Autoimmune disorder 11.96 11.69 10 126684 17167 63345161
Musculoskeletal pain 11.93 11.69 122 126572 92155 63270173
Laryngitis 11.92 11.69 66 126628 16901 63345427
Panniculitis 11.77 11.69 4 126690 11381 63350947

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
Incorrect route of product administration 2981.69 11.25 1193 86964 13652 34855122
Asthma 2661.74 11.25 1534 86623 41122 34827652
Wheezing 1794.87 11.25 1181 86976 40221 34828553
Dyspnoea 1522.15 11.25 3083 85074 373699 34495075
Obstructive airways disorder 1165.41 11.25 631 87526 14863 34853911
Chronic obstructive pulmonary disease 1077.74 11.25 931 87226 47987 34820787
Full blood count abnormal 955.53 11.25 592 87565 18076 34850698
Sleep disorder due to a general medical condition 766.20 11.25 336 87821 4885 34863889
Productive cough 706.25 11.25 656 87501 37157 34831617
Therapeutic product effect incomplete 705.32 11.25 748 87409 49793 34818981
Cough 656.24 11.25 1275 86882 148865 34719909
Loss of personal independence in daily activities 473.14 11.25 497 87660 32682 34836092
Sputum discoloured 405.20 11.25 250 87907 7562 34861212
Forced expiratory volume decreased 380.74 11.25 178 87979 3025 34865749
Chest discomfort 339.81 11.25 542 87615 53988 34814786
Bronchiectasis 339.67 11.25 244 87913 9557 34859217
Dyspnoea exertional 301.54 11.25 453 87704 42826 34825948
Product quality issue 267.71 11.25 269 87888 16766 34852008
Pneumonia 251.63 11.25 1667 86490 360960 34507814
Nasal congestion 231.24 11.25 288 87869 22769 34846005
Off label use 226.27 11.25 449 87708 419075 34449699
Toxicity to various agents 223.92 11.25 113 88044 200249 34668525
Emphysema 220.93 11.25 187 87970 9338 34859436
Breath sounds abnormal 219.59 11.25 163 87994 6718 34862056
Asthma-chronic obstructive pulmonary disease overlap syndrome 218.98 11.25 92 88065 1195 34867579
Pulmonary function test decreased 217.62 11.25 143 88014 4832 34863942
Pulmonary function test abnormal 186.92 11.25 103 88054 2507 34866267
Middle insomnia 183.89 11.25 146 88011 6656 34862118
Lower respiratory tract infection 166.89 11.25 292 87865 31345 34837429
Drug abuse 163.11 11.25 27 88130 99069 34769705
Bronchial wall thickening 159.41 11.25 75 88082 1293 34867481
Nasal polyps 147.59 11.25 87 88070 2416 34866358
Completed suicide 140.49 11.25 37 88120 98131 34770643
Bronchial obstruction 138.87 11.25 72 88085 1544 34867230
Bronchial secretion retention 133.61 11.25 69 88088 1467 34867307
Dust allergy 128.66 11.25 57 88100 849 34867925
Nasal obstruction 127.15 11.25 52 88105 628 34868146
Blood immunoglobulin E increased 125.73 11.25 79 88078 2467 34866307
Benign prostatic hyperplasia 123.36 11.25 167 87990 14328 34854446
Obstruction 120.98 11.25 79 88078 2640 34866134
Lung hyperinflation 119.43 11.25 54 88103 846 34867928
Febrile neutropenia 117.91 11.25 103 88054 136746 34732028
Respiratory disorder 117.81 11.25 190 87967 19074 34849700
Eosinophil count increased 114.28 11.25 124 88033 8448 34860326
Spirometry abnormal 110.76 11.25 48 88109 676 34868098
Eosinophil count abnormal 109.90 11.25 38 88119 276 34868498
Right atrial hypertrophy 105.87 11.25 48 88109 757 34868017
Chronic sinusitis 98.43 11.25 65 88092 2214 34866560
Neutropenia 97.45 11.25 153 88004 156625 34712149
Diarrhoea 94.90 11.25 586 87571 389326 34479448
Sinus pain 94.51 11.25 43 88114 684 34868090
Bronchial hyperreactivity 94.51 11.25 57 88100 1652 34867122
Vital capacity decreased 94.42 11.25 36 88121 356 34868418
Urinary retention 92.90 11.25 250 87907 36038 34832736
Respiratory rate increased 91.90 11.25 119 88038 9775 34858999
Upper-airway cough syndrome 89.02 11.25 73 88084 3485 34865289
Pulmonary mass 87.56 11.25 133 88024 12679 34856095
Bronchitis 86.07 11.25 267 87890 41696 34827078
Mycotic allergy 85.53 11.25 38 88119 570 34868204
Mite allergy 83.38 11.25 39 88118 663 34868111
Congenital hiatus hernia 82.42 11.25 41 88116 803 34867971
Right ventricular hypertrophy 81.84 11.25 50 88107 1484 34867290
Conjunctivitis allergic 80.57 11.25 45 88112 1125 34867649
Gastrooesophageal reflux disease 80.29 11.25 244 87913 37680 34831094
Blood test abnormal 77.87 11.25 92 88065 6879 34861895
Lung disorder 76.06 11.25 226 87931 34470 34834304
Allergy to animal 75.53 11.25 31 88126 378 34868396
Bronchospasm 74.18 11.25 112 88045 10619 34858155
Lung neoplasm malignant 69.90 11.25 143 88014 17252 34851522
Foetal exposure during pregnancy 65.82 11.25 9 88148 38092 34830682
Respiratory failure 65.78 11.25 484 87673 108088 34760686
Disease progression 64.73 11.25 108 88049 107969 34760805
Aortic valve stenosis 64.59 11.25 54 88103 2649 34866125
Oxygen saturation decreased 63.78 11.25 287 87870 53531 34815243
Product use in unapproved indication 63.60 11.25 125 88032 117374 34751400
Thrombocytopenia 63.51 11.25 193 87964 156054 34712720
Dyspnoea at rest 62.98 11.25 62 88095 3766 34865008
Chest X-ray abnormal 62.82 11.25 66 88091 4332 34864442
Mycobacterium avium complex infection 61.74 11.25 51 88106 2460 34866314
Eosinophilia 61.50 11.25 175 87982 26047 34842727
Hypoxia 60.99 11.25 288 87869 54807 34813967
Vocal cord dysfunction 59.75 11.25 21 88136 161 34868613
Bronchopulmonary aspergillosis allergic 59.30 11.25 34 88123 895 34867879
Reversible airways obstruction 57.57 11.25 27 88130 462 34868312
White blood cell count decreased 57.50 11.25 95 88062 95350 34773424
Platelet count decreased 56.82 11.25 137 88020 119580 34749194
Asthmatic crisis 56.79 11.25 27 88130 477 34868297
Forced vital capacity decreased 56.60 11.25 31 88126 745 34868029
Intentional product use issue 56.51 11.25 41 88116 59775 34808999
Haemoptysis 56.07 11.25 205 87952 34801 34833973
Intentional overdose 56.07 11.25 20 88137 43654 34825120
Rhinorrhoea 55.12 11.25 166 87991 25502 34843272
Eosinophil count 55.07 11.25 19 88138 137 34868637
Rhinitis perennial 54.38 11.25 23 88134 304 34868470
Multiple organ dysfunction syndrome 54.21 11.25 68 88089 76498 34792276
Sputum purulent 54.15 11.25 26 88131 470 34868304
Sensitivity to weather change 52.95 11.25 39 88118 1587 34867187
Neuropathy peripheral 51.92 11.25 81 88076 83182 34785592
Pancytopenia 51.68 11.25 101 88056 95056 34773718
Vomiting 51.19 11.25 390 87767 247231 34621543
Alanine aminotransferase increased 50.98 11.25 78 88079 80737 34788037
Lung consolidation 49.90 11.25 68 88089 5868 34862906
Sputum increased 49.82 11.25 44 88113 2326 34866448
Throat irritation 49.80 11.25 93 88064 10492 34858282
Dry mouth 49.45 11.25 178 87979 29987 34838787
Diastolic dysfunction 48.85 11.25 69 88088 6158 34862616
Influenza 48.82 11.25 251 87906 49415 34819359
Nausea 48.35 11.25 587 87570 339321 34529453
Malaise 46.64 11.25 692 87465 185133 34683641
Sepsis 45.90 11.25 240 87917 166321 34702453
Seizure 45.89 11.25 125 88032 104732 34764042
Nasopharyngitis 44.11 11.25 315 87842 69653 34799121
Suffocation feeling 44.00 11.25 24 88133 572 34868202
Respiratory tract congestion 43.75 11.25 65 88092 6074 34862700
Drug resistance 42.76 11.25 7 88150 25920 34842854
Restrictive pulmonary disease 41.76 11.25 30 88127 1174 34867600
Peak expiratory flow rate decreased 41.70 11.25 15 88142 124 34868650
Sleep apnoea syndrome 41.37 11.25 129 88028 20192 34848582
Aspartate aminotransferase increased 41.25 11.25 67 88090 67716 34801058
Cytomegalovirus infection 41.06 11.25 8 88149 26127 34842647
Dysphonia 40.92 11.25 141 88016 23242 34845532
Heart rate increased 39.98 11.25 226 87931 46117 34822657
Sinusitis 39.83 11.25 208 87949 41194 34827580
Total lung capacity abnormal 39.73 11.25 15 88142 144 34868630
Respiratory symptom 39.06 11.25 34 88123 1763 34867011
Normochromic normocytic anaemia 38.93 11.25 51 88106 4236 34864538
Fractured coccyx 38.67 11.25 15 88142 156 34868618
Eosinophilic granulomatosis with polyangiitis 38.05 11.25 35 88122 1952 34866822
Forced expiratory flow decreased 38.00 11.25 15 88142 164 34868610
Intentional product misuse 37.24 11.25 36 88121 45575 34823199
Mucosal inflammation 37.09 11.25 26 88131 38596 34830178
Infusion related reaction 36.64 11.25 48 88109 53009 34815765
Hypoventilation 36.39 11.25 44 88113 3370 34865404
Obesity 36.29 11.25 92 88065 12786 34855988
Brain natriuretic peptide abnormal 36.21 11.25 18 88139 352 34868422
Intervertebral disc degeneration 36.14 11.25 61 88096 6356 34862418
Seasonal allergy 35.68 11.25 62 88095 6613 34862161
Blood pressure systolic increased 35.56 11.25 133 88024 22819 34845955
Pancreatitis 35.01 11.25 28 88129 38863 34829911
Decreased activity 34.99 11.25 49 88108 4338 34864436
Body temperature decreased 34.55 11.25 91 88066 12943 34855831
Pickwickian syndrome 34.48 11.25 11 88146 60 34868714
Throat clearing 34.26 11.25 17 88140 331 34868443
Osteopenia 34.07 11.25 51 88106 4798 34863976
Cytokine release syndrome 33.90 11.25 8 88149 22869 34845905
Leukopenia 33.87 11.25 67 88090 62789 34805985
Serotonin syndrome 33.74 11.25 5 88152 19928 34848846
Impaired quality of life 33.69 11.25 56 88101 5762 34863012
Treatment failure 33.54 11.25 41 88116 46656 34822118
Stomatitis 33.06 11.25 35 88122 42479 34826295
Lung opacity 32.98 11.25 35 88122 2324 34866450
Lung diffusion test decreased 32.51 11.25 20 88137 601 34868173
Malignant melanoma in situ 32.24 11.25 30 88127 1698 34867076
Osteoporosis 32.12 11.25 87 88070 12581 34856193
Respiratory tract infection 32.03 11.25 116 88041 19596 34849178
Septic shock 31.89 11.25 85 88072 71749 34797025
Dyspnoea paroxysmal nocturnal 31.85 11.25 28 88129 1471 34867303
Atrial fibrillation 31.53 11.25 458 87699 121935 34746839
Mycobacterial infection 31.04 11.25 34 88123 2340 34866434
Oxygen saturation increased 30.71 11.25 15 88142 282 34868492
Bone marrow failure 30.40 11.25 18 88139 29235 34839539
Drug hypersensitivity 30.22 11.25 103 88054 80426 34788348
Dysarthria 30.12 11.25 26 88131 34756 34834018
Pyrexia 29.55 11.25 628 87529 332385 34536389
Drug reaction with eosinophilia and systemic symptoms 29.42 11.25 24 88133 32988 34835786
Granulomatous rosacea 29.41 11.25 12 88145 144 34868630
Aptyalism 29.23 11.25 16 88141 384 34868390
N-terminal prohormone brain natriuretic peptide abnormal 29.20 11.25 13 88144 196 34868578
Psoriatic arthropathy 29.19 11.25 7 88150 19791 34848983
Cardiac failure 29.11 11.25 355 87802 90893 34777881
Nocturnal dyspnoea 28.96 11.25 18 88139 551 34868223
Eye disorder 28.89 11.25 70 88087 9458 34859316
Malignant neoplasm progression 28.88 11.25 119 88038 87927 34780847
Pulmonary arterial pressure abnormal 28.73 11.25 13 88144 204 34868570
Adjustment disorder 28.71 11.25 24 88133 1177 34867597
Therapy non-responder 28.50 11.25 34 88123 39112 34829662
Suicide attempt 28.45 11.25 34 88123 39082 34829692
Somnolence 28.44 11.25 164 87993 110952 34757822
Factitious disorder 28.38 11.25 9 88148 48 34868726
Prostatic adenoma 27.95 11.25 12 88145 165 34868609
Prolonged expiration 27.69 11.25 13 88144 223 34868551
Hypercholesterolaemia 27.24 11.25 65 88092 8697 34860077
Hepatocellular injury 27.12 11.25 11 88146 22200 34846574
Pleural thickening 27.04 11.25 15 88142 370 34868404
Drug ineffective for unapproved indication 26.98 11.25 13 88144 23702 34845072
Drug-induced liver injury 26.91 11.25 20 88137 28812 34839962
Pulmonary congestion 26.75 11.25 86 88071 13679 34855095
Adverse drug reaction 26.56 11.25 21 88136 29321 34839453
Sputum abnormal 25.97 11.25 16 88141 482 34868292
Renal impairment 25.54 11.25 137 88020 94376 34774398
Discomfort 25.50 11.25 105 88052 18833 34849941
Orthopnoea 25.47 11.25 46 88111 5057 34863717
Hypochromic anaemia 25.04 11.25 20 88137 919 34867855
Hepatic function abnormal 25.02 11.25 46 88111 44317 34824457
Decreased gait velocity 24.82 11.25 11 88146 164 34868610
Choking 24.77 11.25 45 88112 4970 34863804
Snoring 24.67 11.25 36 88121 3310 34865464
Hepatic enzyme increased 24.36 11.25 38 88119 39042 34829732
Lower respiratory tract congestion 24.25 11.25 22 88135 1205 34867569
Rhinitis allergic 24.23 11.25 34 88123 3016 34865758
Acute respiratory failure 24.19 11.25 147 88010 30781 34837993
Rhinitis 24.16 11.25 51 88106 6287 34862487
Nasal disorder 24.15 11.25 27 88130 1901 34866873
COVID-19 24.09 11.25 107 88050 77443 34791331
Hepatic haematoma 23.51 11.25 14 88143 396 34868378
Lacrimal disorder 23.35 11.25 13 88144 323 34868451
Rales 23.21 11.25 66 88091 9817 34858957
Confusional state 23.15 11.25 242 87915 143918 34724856
Proteinuria 23.14 11.25 9 88148 18633 34850141
Ascites 23.10 11.25 52 88105 46519 34822255
Gout 23.03 11.25 103 88054 19150 34849624
Cardiogenic shock 22.92 11.25 20 88137 26598 34842176
Multiple sclerosis relapse 22.92 11.25 3 88154 13130 34855644
Pain 22.77 11.25 371 87786 204304 34664470
Coma 22.66 11.25 51 88106 45627 34823147
Sarcopenia 22.48 11.25 14 88143 430 34868344
Convulsive threshold lowered 22.40 11.25 15 88142 523 34868251
Haemophilus infection 22.40 11.25 21 88136 1200 34867574
Nasal oedema 22.18 11.25 13 88144 357 34868417
Electrocardiogram QRS complex abnormal 22.11 11.25 13 88144 359 34868415
Pneumothorax 21.99 11.25 101 88056 18991 34849783
Sputum retention 21.97 11.25 14 88143 448 34868326
Vascular shunt 21.97 11.25 7 88150 38 34868736
Overdose 21.92 11.25 137 88020 90922 34777852
Oropharyngeal pain 21.91 11.25 159 87998 35326 34833448
Left ventricular dilatation 21.89 11.25 17 88140 750 34868024
Rash 21.83 11.25 413 87744 222339 34646435
Acute respiratory distress syndrome 21.78 11.25 20 88137 25949 34842825
Electrocardiogram QT prolonged 21.75 11.25 44 88113 40908 34827866
Bronchiolitis 21.74 11.25 33 88124 3143 34865631
Type 2 diabetes mellitus 21.67 11.25 89 88068 15943 34852831
Infective exacerbation of chronic obstructive airways disease 21.62 11.25 25 88132 1826 34866948
Aphonia 21.62 11.25 34 88123 3339 34865435
Oropharyngeal discomfort 21.58 11.25 33 88124 3163 34865611
Blood thyroid stimulating hormone abnormal 21.55 11.25 13 88144 377 34868397
Joint injury 21.29 11.25 61 88096 9112 34859662
Cholestasis 21.16 11.25 22 88135 26926 34841848
Sneezing 20.94 11.25 43 88114 5199 34863575
Poisoning 20.85 11.25 3 88154 12223 34856551
Total lung capacity decreased 20.65 11.25 18 88139 935 34867839
Encephalopathy 20.47 11.25 36 88121 35283 34833491
Hypopnoea 20.43 11.25 27 88130 2262 34866512
Anaemia 20.37 11.25 441 87716 232894 34635880
Flour sensitivity 20.32 11.25 6 88151 24 34868750
Acute kidney injury 20.30 11.25 600 87557 304388 34564386
Hepatic failure 20.20 11.25 35 88122 34496 34834278
Neutrophil count decreased 20.10 11.25 64 88093 51040 34817734
Lymphopenia 20.09 11.25 8 88149 16327 34852447
Tachyarrhythmia 19.92 11.25 34 88123 3574 34865200
Choking sensation 19.91 11.25 19 88138 1110 34867664
Cardio-respiratory arrest 19.85 11.25 72 88085 55201 34813573
Diaphragmatic disorder 19.77 11.25 20 88137 1255 34867519
C-reactive protein increased 19.74 11.25 70 88087 54028 34814746
Hyperkaliuria 19.61 11.25 8 88149 96 34868678
Bronchitis chronic 19.29 11.25 21 88136 1435 34867339
Product use issue 19.16 11.25 88 88069 63128 34805646
Panic reaction 19.07 11.25 21 88136 1454 34867320
Joint swelling 18.98 11.25 82 88075 59808 34808966
Hyperglycaemia 18.84 11.25 45 88112 39435 34829339
Weight decreased 18.63 11.25 579 87578 175722 34693052
Drug level increased 18.55 11.25 17 88140 22079 34846695
Haemoglobin decreased 18.47 11.25 205 87952 120567 34748207
Pneumothorax spontaneous 18.35 11.25 14 88143 601 34868173
Atheroembolism 18.23 11.25 11 88146 319 34868455
Cardiac failure congestive 18.14 11.25 303 87854 82967 34785807
Primary hypogonadism 18.11 11.25 7 88150 72 34868702
Respiratory tract haemorrhage 18.03 11.25 19 88138 1251 34867523
Sinus congestion 17.88 11.25 42 88115 5563 34863211
Bradycardia 17.88 11.25 114 88043 75304 34793470
Blood alkaline phosphatase increased 17.87 11.25 32 88125 31143 34837631
Cytopenia 17.80 11.25 5 88152 12718 34856056
Cough decreased 17.79 11.25 5 88152 16 34868758
Transaminases increased 17.77 11.25 25 88132 26798 34841976
Hepatotoxicity 17.49 11.25 17 88140 21468 34847306
Musculoskeletal stiffness 17.30 11.25 60 88097 46620 34822154
Hangover 17.25 11.25 17 88140 1034 34867740
Rib fracture 17.20 11.25 77 88080 14323 34854451
Increased upper airway secretion 17.17 11.25 22 88135 1788 34866986
Renal failure 17.16 11.25 229 87928 130328 34738446
Rheumatoid arthritis 17.15 11.25 45 88112 38193 34830581
Psychotic disorder 17.00 11.25 22 88135 24430 34844344
Dyskinesia 16.82 11.25 19 88138 22394 34846380
Hernia pain 16.79 11.25 10 88147 283 34868491
Eosinophilic pneumonia chronic 16.73 11.25 10 88147 285 34868489
Illness 16.65 11.25 73 88084 13456 34855318
Increased viscosity of bronchial secretion 16.56 11.25 9 88148 213 34868561
Blood bilirubin increased 16.47 11.25 46 88111 38250 34830524
Hypoacusis 16.44 11.25 83 88074 16218 34852556
Upper respiratory tract congestion 16.40 11.25 15 88142 830 34867944
Blood creatine phosphokinase increased 16.40 11.25 58 88099 44799 34823975
Dehydration 16.35 11.25 230 87927 129739 34739035
Bronchospasm paradoxical 16.04 11.25 6 88151 56 34868718
FEV1/FVC ratio decreased 16.00 11.25 7 88150 101 34868673
Bone deformity 15.95 11.25 6 88151 57 34868717
Pseudomonas bronchitis 15.87 11.25 5 88152 26 34868748
Nephrolithiasis 15.76 11.25 33 88124 30300 34838474
Peritonitis 15.73 11.25 11 88146 16354 34852420
Drug interaction 15.64 11.25 442 87715 225504 34643270
Laboratory test abnormal 15.61 11.25 17 88140 20374 34848400
Agitation 15.61 11.25 83 88074 57316 34811458
Mastication disorder 15.57 11.25 18 88139 1315 34867459
Appendicitis 15.54 11.25 9 88148 14798 34853976
Hyperbilirubinaemia 15.31 11.25 12 88145 16831 34851943
Mesothelioma 15.23 11.25 11 88146 434 34868340
Lung hernia 15.17 11.25 6 88151 66 34868708
Neoplasm progression 15.15 11.25 22 88135 23278 34845496
FEV1/FVC ratio abnormal 15.13 11.25 5 88152 31 34868743
Cardiac failure chronic 15.10 11.25 49 88108 7830 34860944
Carbon dioxide increased 15.04 11.25 16 88141 1065 34867709
Blood creatinine increased 15.00 11.25 160 87997 94816 34773958
Intentional self-injury 14.99 11.25 8 88149 13763 34855011
Atelectasis 14.98 11.25 86 88071 17641 34851133
Large cell lung cancer metastatic 14.96 11.25 4 88153 10 34868764
Multiple allergies 14.90 11.25 27 88130 2976 34865798
Lower respiratory tract infection viral 14.83 11.25 10 88147 353 34868421
Blood pressure increased 14.82 11.25 308 87849 87794 34780980
Laryngitis 14.60 11.25 23 88134 2262 34866512
Tubulointerstitial nephritis 14.53 11.25 19 88138 21005 34847769
Sedation 14.50 11.25 19 88138 20987 34847787
Forced expiratory volume abnormal 14.50 11.25 5 88152 36 34868738
Rhonchi 14.49 11.25 21 88136 1919 34866855
Tumour lysis syndrome 14.47 11.25 13 88144 17046 34851728
Ischaemic cardiomyopathy 14.36 11.25 42 88115 6347 34862427
Delusion 14.26 11.25 7 88150 12628 34856146
Abscess 14.19 11.25 6 88151 11811 34856963
Smoke sensitivity 14.03 11.25 7 88150 138 34868636
Umbilical hernia 13.79 11.25 34 88123 4643 34864131
Deep vein thrombosis 13.79 11.25 102 88055 65146 34803628
Eosinophilic bronchitis 13.77 11.25 8 88149 216 34868558
Magnetic resonance imaging heart 13.75 11.25 4 88153 15 34868759
Liver function test increased 13.73 11.25 10 88147 14555 34854219
Blood lactate dehydrogenase increased 13.72 11.25 23 88134 22967 34845807
Hypothermia 13.66 11.25 5 88152 10743 34858031
Paraneoplastic rash 13.63 11.25 6 88151 88 34868686
Exercise tolerance decreased 13.48 11.25 36 88121 5162 34863612
Congenital megaureter 13.46 11.25 7 88150 151 34868623
Pulmonary artery dilatation 13.41 11.25 8 88149 227 34868547
Apnoeic attack 13.38 11.25 10 88147 416 34868358
Lactic acidosis 13.36 11.25 44 88113 34728 34834046
Abdominal symptom 13.32 11.25 11 88146 530 34868244
Blood glucose increased 13.30 11.25 106 88051 66612 34802162
Hepatitis 13.29 11.25 25 88132 23879 34844895
Aplastic anaemia 13.26 11.25 4 88153 9712 34859062
Xanthelasma 13.21 11.25 6 88151 95 34868679
Status asthmaticus 13.14 11.25 9 88148 326 34868448
Eye swelling 13.13 11.25 55 88102 9940 34858834
Nasal septum deviation 13.10 11.25 15 88142 1084 34867690
Respiratory depression 13.05 11.25 13 88144 16232 34852542
Lichenoid keratosis 13.02 11.25 23 88134 2485 34866289
Pulmonary arterial hypertension 13.00 11.25 50 88107 8689 34860085
Fatigue 13.00 11.25 784 87373 369869 34498905
Upper respiratory tract infection 12.97 11.25 134 88023 32925 34835849
Idiopathic pulmonary fibrosis 12.97 11.25 28 88129 3506 34865268
Renal injury 12.94 11.25 6 88151 11189 34857585
Intercostal neuralgia 12.88 11.25 3 88154 3 34868771
Right ventricular failure 12.86 11.25 50 88107 8734 34860040
Acute hepatic failure 12.83 11.25 10 88147 14064 34854710
Humidity intolerance 12.83 11.25 4 88153 20 34868754
Blood immunoglobulin E abnormal 12.83 11.25 4 88153 20 34868754
Transplant rejection 12.76 11.25 5 88152 10306 34858468
Tracheal disorder 12.75 11.25 7 88150 169 34868605
No adverse event 12.72 11.25 24 88133 22903 34845871
Expiratory reserve volume decreased 12.72 11.25 5 88152 54 34868720
Total lung capacity 12.66 11.25 4 88153 21 34868753
Hypotension 12.58 11.25 445 87712 221204 34647570
Device related infection 12.51 11.25 15 88142 17222 34851552
Respiratory gas exchange disorder 12.47 11.25 10 88147 462 34868312
Nervous system disorder 12.43 11.25 11 88146 14532 34854242
Precancerous condition 12.40 11.25 5 88152 58 34868716
Suicidal ideation 12.37 11.25 56 88101 40332 34828442
Concomitant disease aggravated 12.36 11.25 37 88120 5664 34863110
Paraesthesia 12.31 11.25 103 88054 64069 34804705
Nasal inflammation 12.26 11.25 8 88149 267 34868507
Lipohypertrophy 12.18 11.25 8 88149 270 34868504
Drug intolerance 12.17 11.25 94 88063 59476 34809298
Increased bronchial secretion 12.11 11.25 19 88138 1862 34866912
Immune thrombocytopenia 12.07 11.25 4 88153 9148 34859626
Posterior reversible encephalopathy syndrome 12.04 11.25 5 88152 9949 34858825
Oxygen consumption increased 12.02 11.25 16 88141 1350 34867424
Oxygen therapy 12.01 11.25 13 88144 883 34867891
Shock 11.99 11.25 27 88130 24152 34844622
Aortic aneurysm 11.96 11.25 41 88116 6738 34862036
Hypoalbuminaemia 11.95 11.25 8 88149 12166 34856608
Blood albumin decreased 11.93 11.25 10 88147 13562 34855212
Febrile bone marrow aplasia 11.91 11.25 3 88154 8206 34860568
Viral myelitis 11.90 11.25 5 88152 65 34868709
Abdominal pain 11.84 11.25 318 87839 163300 34705474
Altered state of consciousness 11.82 11.25 25 88132 22868 34845906
Drug eruption 11.79 11.25 20 88137 19878 34848896
Systolic dysfunction 11.76 11.25 23 88134 2685 34866089
Diabetic ketoacidosis 11.75 11.25 17 88140 18015 34850759
Myositis 11.75 11.25 8 88149 12062 34856712
Neurotoxicity 11.72 11.25 17 88140 17993 34850781
Decreased appetite 11.63 11.25 325 87832 166067 34702707
Necrotising ulcerative gingivostomatitis 11.56 11.25 5 88152 70 34868704
Hepatic encephalopathy 11.51 11.25 12 88145 14673 34854101
Hallucination, auditory 11.47 11.25 8 88149 11909 34856865
Basal cell carcinoma 11.43 11.25 20 88137 19638 34849136
Temperature intolerance 11.31 11.25 26 88131 3396 34865378
Hypohidrosis 11.30 11.25 7 88150 213 34868561
Hydronephrosis 11.28 11.25 6 88151 10340 34858434
Nasal discomfort 11.26 11.25 17 88140 1611 34867163

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
Asthma 4621.32 10.88 3163 173275 131932 79436018
Wheezing 2884.70 10.88 2247 174191 114417 79453533
Dyspnoea 2514.81 10.88 5703 170735 851322 78716628
Obstructive airways disorder 2329.97 10.88 1214 175224 30245 79537705
Incorrect route of product administration 2202.29 10.88 1211 175227 33718 79534232
Chronic obstructive pulmonary disease 1749.38 10.88 1475 174963 83944 79484006
Full blood count abnormal 1649.24 10.88 1059 175379 39415 79528535
Productive cough 1458.27 10.88 1350 175088 86981 79480969
Cough 1319.12 10.88 2660 173778 364129 79203821
Sleep disorder due to a general medical condition 1154.97 10.88 585 175853 13692 79554258
Forced expiratory volume decreased 998.71 10.88 439 175999 7375 79560575
Sputum discoloured 947.94 10.88 594 175844 21149 79546801
Product quality issue 675.37 10.88 577 175861 33363 79534587
Pneumonia 623.54 10.88 2996 173442 657250 78910700
Therapeutic product effect incomplete 620.42 10.88 1119 175319 140526 79427424
Chest discomfort 592.44 10.88 1081 175357 136963 79430987
Dyspnoea exertional 555.67 10.88 816 175622 86257 79481693
Loss of personal independence in daily activities 492.53 10.88 844 175594 101736 79466214
Sedation complication 448.49 10.88 330 176108 15339 79552611
Bronchiectasis 444.13 10.88 380 176058 22006 79545944
Off label use 440.29 10.88 839 175599 906376 78661574
Middle insomnia 436.61 10.88 328 176110 15741 79552209
Creatinine renal clearance decreased 429.81 10.88 348 176090 18654 79549296
Completed suicide 410.76 10.88 36 176402 245731 79322219
Nasal congestion 374.15 10.88 635 175803 75917 79492033
Breath sounds abnormal 334.87 10.88 280 176158 15704 79552246
Synovitis 292.29 10.88 9 176429 150725 79417225
Blood immunoglobulin E increased 290.27 10.88 174 176264 5708 79562242
Asthma-chronic obstructive pulmonary disease overlap syndrome 290.04 10.88 142 176296 3079 79564871
Eosinophil count increased 286.79 10.88 264 176174 16841 79551109
Emphysema 274.12 10.88 252 176186 16048 79551902
Blood calcium decreased 270.76 10.88 343 176095 31476 79536474
Nasal polyps 267.19 10.88 179 176259 7148 79560802
Orthostatic hypotension 266.64 10.88 460 175978 55704 79512246
Pulmonary function test decreased 265.19 10.88 181 176257 7456 79560494
Upper-airway cough syndrome 264.12 10.88 214 176224 11479 79556471
Bronchitis 263.41 10.88 759 175679 129885 79438065
Bronchial secretion retention 263.11 10.88 144 176294 3960 79563990
Bronchial wall thickening 251.57 10.88 121 176317 2520 79565430
Sedation 238.48 10.88 419 176019 51476 79516474
Balance disorder 233.77 10.88 609 175829 98248 79469702
Reversible airways obstruction 232.78 10.88 108 176330 2068 79565882
Pulmonary mass 229.84 10.88 302 176136 28732 79539218
Cognitive disorder 211.71 10.88 474 175964 69452 79498498
Pulmonary function test abnormal 208.16 10.88 124 176314 4020 79563930
Drug abuse 205.70 10.88 53 176385 162638 79405312
Treatment failure 203.54 10.88 62 176376 170424 79397526
Nasal obstruction 202.66 10.88 98 176340 2066 79565884
Drug intolerance 197.64 10.88 176 176262 263943 79304007
Dysphonia 194.47 10.88 405 176033 56467 79511483
Respiratory tract infection 192.00 10.88 368 176070 48321 79519629
Hand deformity 191.90 10.88 9 176429 103910 79464040
Forced vital capacity decreased 187.98 10.88 87 176351 1656 79566294
Neutropenia 184.39 10.88 219 176219 287491 79280459
Febrile neutropenia 183.80 10.88 145 176293 230854 79337096
Contraindicated product administered 183.23 10.88 60 176378 157478 79410472
Arthropathy 181.87 10.88 82 176356 177029 79390921
Vital capacity decreased 178.45 10.88 85 176353 1731 79566219
Lung neoplasm malignant 176.47 10.88 260 176178 27532 79540418
Asthmatic crisis 176.34 10.88 87 176351 1919 79566031
Systemic lupus erythematosus 172.51 10.88 30 176408 121119 79446831
Eosinophilia 170.60 10.88 336 176102 45009 79522941
Dust allergy 169.82 10.88 78 176360 1458 79566492
Influenza 168.23 10.88 649 175789 128957 79438993
Maternal exposure during pregnancy 167.83 10.88 47 176391 136491 79431459
Respiratory rate increased 165.30 10.88 221 176217 21379 79546571
Lower respiratory tract infection 165.22 10.88 644 175794 128576 79439374
Alopecia 163.85 10.88 162 176276 231193 79336757
Hypoventilation 162.71 10.88 132 176306 7092 79560858
Throat clearing 161.56 10.88 90 176348 2564 79565386
Total lung capacity increased 159.50 10.88 85 176353 2213 79565737
Respiratory tract congestion 158.62 10.88 208 176230 19746 79548204
Spirometry abnormal 156.16 10.88 64 176374 895 79567055
Joint swelling 154.60 10.88 250 176188 288396 79279554
Pericarditis 152.44 10.88 24 176414 104212 79463738
Rheumatoid arthritis 151.07 10.88 143 176295 208327 79359623
Infusion related reaction 150.98 10.88 172 176266 230065 79337885
Rales 147.51 10.88 201 176237 19800 79548150
Restrictive pulmonary disease 147.14 10.88 84 176354 2511 79565439
Intentional overdose 147.06 10.88 28 176410 105932 79462018
Hepatic enzyme increased 144.77 10.88 115 176323 182495 79385455
Respiratory disorder 144.74 10.88 312 176126 44544 79523406
Bronchial obstruction 144.73 10.88 85 176353 2683 79565267
Exposure during pregnancy 144.08 10.88 25 176413 101107 79466843
Lung hyperinflation 143.98 10.88 74 176364 1785 79566165
Gastrooesophageal reflux disease 143.52 10.88 532 175906 103714 79464236
Eosinophil count abnormal 142.65 10.88 56 176382 695 79567255
Sensitivity to weather change 142.33 10.88 128 176310 7919 79560031
Sleep apnoea syndrome 140.50 10.88 273 176165 36205 79531745
Bronchopulmonary aspergillosis allergic 139.36 10.88 86 176352 2975 79564975
Vocal cord dysfunction 138.82 10.88 52 176386 563 79567387
Peak expiratory flow rate decreased 137.06 10.88 53 176385 630 79567320
Helicobacter infection 135.68 10.88 4 176434 69700 79498250
Intentional product use issue 134.77 10.88 85 176353 152027 79415923
Blood test abnormal 133.68 10.88 180 176258 17530 79550420
Haemoptysis 130.30 10.88 343 176095 55656 79512294
Bronchospasm 129.11 10.88 212 176226 24647 79543303
Secretion discharge 127.88 10.88 162 176276 14860 79553090
Therapeutic product effect decreased 122.74 10.88 109 176329 163754 79404196
Thrombocytopenia 122.17 10.88 252 176186 265007 79302943
Eosinophilic granulomatosis with polyangiitis 120.61 10.88 84 176354 3576 79564374
Oxygen saturation decreased 118.96 10.88 583 175855 128464 79439486
Depressed level of consciousness 117.32 10.88 474 175964 96178 79471772
Multiple allergies 115.81 10.88 129 176309 10331 79557619
Mite allergy 113.07 10.88 55 176383 1175 79566775
Glossodynia 112.23 10.88 44 176394 103293 79464657
Lung diffusion test decreased 109.78 10.88 55 176383 1255 79566695
Psoriatic arthropathy 109.54 10.88 20 176418 77979 79489971
White blood cell count decreased 108.54 10.88 155 176283 188133 79379817
Malaise 107.78 10.88 1600 174838 488269 79079681
Right atrial hypertrophy 107.26 10.88 46 176392 725 79567225
Benign prostatic hyperplasia 106.50 10.88 130 176308 11482 79556468
Seasonal allergy 104.89 10.88 154 176284 16252 79551698
Heart rate increased 104.63 10.88 536 175902 120188 79447762
Wound 104.17 10.88 64 176374 116115 79451835
Diarrhoea 103.65 10.88 1351 175087 879138 78688812
Blood pressure systolic increased 100.81 10.88 352 176086 66634 79501316
Hypoxia 99.88 10.88 473 175965 102770 79465180
Lung disorder 98.50 10.88 396 176042 80161 79487789
Abdominal discomfort 97.96 10.88 260 176178 250467 79317483
Arthralgia 97.72 10.88 803 175635 571000 78996950
Folliculitis 95.53 10.88 7 176431 55373 79512577
Obstruction 94.99 10.88 80 176358 4530 79563420
Nausea 93.37 10.88 1524 174914 955672 78612278
Pancytopenia 92.05 10.88 140 176298 165605 79402345
Lung diffusion test abnormal 91.78 10.88 34 176404 356 79567594
Prolonged expiration 91.01 10.88 48 176390 1223 79566727
Allergy to animal 90.89 10.88 50 176388 1389 79566561
Respiration abnormal 89.60 10.88 98 176340 7690 79560260
Nasopharyngitis 89.16 10.88 906 175532 252975 79314975
Disease progression 88.40 10.88 171 176267 184191 79383759
Alanine aminotransferase increased 87.73 10.88 140 176298 162430 79405520
Right ventricular hypertrophy 87.51 10.88 51 176387 1586 79566364
Total lung capacity decreased 87.24 10.88 63 176375 2842 79565108
Mobility decreased 86.80 10.88 514 175924 121661 79446289
Rash 86.19 10.88 841 175597 577517 78990433
Congenital hiatus hernia 85.36 10.88 40 176398 784 79567166
Irritable bowel syndrome 85.19 10.88 17 176421 62224 79505726
Bronchial hyperreactivity 84.68 10.88 63 176375 2977 79564973
Fall 83.95 10.88 1530 174908 486099 79081851
Product use issue 83.92 10.88 215 176223 209607 79358343
Rhinorrhoea 83.64 10.88 362 176076 75712 79492238
Drug hypersensitivity 83.28 10.88 359 176079 298557 79269393
Conjunctivitis allergic 82.59 10.88 50 176388 1670 79566280
Platelet count decreased 82.14 10.88 194 176244 194470 79373480
Toxicity to various agents 81.88 10.88 571 175867 420969 79146981
Chest X-ray abnormal 81.80 10.88 94 176344 7789 79560161
Oropharyngeal pain 80.23 10.88 464 175974 108889 79459061
Musculoskeletal stiffness 79.07 10.88 168 176270 174840 79393110
Impaired healing 78.98 10.88 48 176390 87607 79480343
Seizure 78.23 10.88 190 176248 188644 79379306
Product use in unapproved indication 76.45 10.88 290 176148 250069 79317881
Rhinitis allergic 75.32 10.88 113 176325 12156 79555794
Aspartate aminotransferase increased 75.17 10.88 119 176319 138522 79429428
Rhinitis 73.83 10.88 124 176314 14683 79553267
Multiple organ dysfunction syndrome 73.30 10.88 95 176343 120151 79447799
Sputum culture positive 72.57 10.88 63 176375 3718 79564232
Drug ineffective 72.43 10.88 1831 174607 1079082 78488868
Constipation 71.58 10.88 948 175490 282102 79285848
Blister 71.19 10.88 96 176342 119380 79448570
Cardiac murmur 69.12 10.88 125 176313 15699 79552251
Respiratory failure 69.03 10.88 657 175781 180254 79387696
Drug-induced liver injury 68.79 10.88 30 176408 66087 79501863
Gastrointestinal disorder 68.06 10.88 103 176335 122102 79445848
Intentional product misuse 68.05 10.88 66 176372 95099 79472851
Choking 68.03 10.88 107 176331 11994 79555956
Chronic sinusitis 67.52 10.88 111 176327 12915 79555035
Suicide attempt 67.24 10.88 51 176387 82881 79485069
Stomatitis 66.19 10.88 141 176297 146616 79421334
Lower respiratory tract congestion 65.65 10.88 61 176377 3936 79564014
Upper respiratory tract infection 65.03 10.88 384 176054 90784 79477166
Mycotic allergy 64.92 10.88 41 176397 1478 79566472
Lung opacity 64.61 10.88 68 176370 5106 79562844
Forced expiratory flow decreased 63.65 10.88 24 176414 265 79567685
Swelling 61.73 10.88 258 176180 216453 79351497
C-reactive protein increased 61.56 10.88 120 176318 128907 79439043
Infective exacerbation of chronic obstructive airways disease 60.87 10.88 50 176388 2734 79565216
Therapy non-responder 60.41 10.88 69 176369 92236 79475714
Body temperature decreased 60.17 10.88 182 176256 31963 79535987
Cytomegalovirus infection 59.73 10.88 11 176427 42633 79525317
Neuropathy peripheral 59.45 10.88 141 176297 141164 79426786
Dyspnoea at rest 59.40 10.88 77 176361 7225 79560725
Rhinitis perennial 58.92 10.88 24 176414 330 79567620
C-reactive protein abnormal 58.76 10.88 17 176421 48350 79519600
Smoke sensitivity 58.00 10.88 28 176410 588 79567362
Malignant neoplasm progression 57.77 10.88 135 176303 135855 79432095
Rubber sensitivity 57.30 10.88 40 176398 1709 79566241
Impaired quality of life 57.02 10.88 109 176329 14277 79553673
Hyper IgE syndrome 56.94 10.88 27 176411 544 79567406
Liver injury 56.86 10.88 27 176411 56587 79511363
Sputum purulent 56.63 10.88 36 176402 1313 79566637
Blood cholesterol increased 56.52 10.88 61 176377 83659 79484291
Hypercapnia 55.86 10.88 83 176355 8852 79559098
Humidity intolerance 55.69 10.88 24 176414 383 79567567
Drug reaction with eosinophilia and systemic symptoms 55.38 10.88 37 176401 64207 79503743
Multiple sclerosis relapse 55.36 10.88 17 176421 46516 79521434
Drug ineffective for unapproved indication 55.32 10.88 22 176416 51216 79516734
Overdose 55.16 10.88 215 176223 183991 79383959
Coma 54.92 10.88 86 176352 100563 79467387
Cardio-respiratory arrest 54.33 10.88 98 176340 108412 79459538
Blood pressure increased 53.44 10.88 708 175730 210652 79357298
Drug resistance 52.85 10.88 14 176424 42199 79525751
Acute respiratory failure 52.70 10.88 266 176172 59275 79508675
Septic shock 52.08 10.88 122 176316 122679 79445271
Eosinophil count 51.16 10.88 17 176421 125 79567825
Cholestasis 50.59 10.88 26 176412 52083 79515867
Weight decreased 50.43 10.88 1083 175355 354115 79213835
Rib deformity 49.97 10.88 19 176419 215 79567735
Total lung capacity abnormal 49.81 10.88 19 176419 217 79567733
Leukopenia 49.22 10.88 116 176322 116397 79451553
Perfume sensitivity 48.62 10.88 28 176410 851 79567099
Pregnancy 47.46 10.88 3 176435 26848 79541102
Hepatocellular injury 47.33 10.88 23 176415 47570 79520380
Status asthmaticus 46.94 10.88 29 176409 1005 79566945
Throat irritation 46.66 10.88 197 176241 40749 79527201
Broncholithiasis 45.81 10.88 18 176420 224 79567726
Aphonia 45.73 10.88 82 176356 10230 79557720
Vomiting 44.91 10.88 1126 175312 664702 78903248
Red blood cell sedimentation rate increased 44.49 10.88 23 176415 45919 79522031
Knee arthroplasty 44.40 10.88 20 176418 43228 79524722
Oesophageal spasm 44.19 10.88 46 176392 3410 79564540
Respiratory gas exchange disorder 44.14 10.88 26 176412 825 79567125
Mucosal inflammation 43.74 10.88 62 176376 75518 79492432
Heart sounds 43.62 10.88 27 176411 939 79567011
Hepatic function abnormal 43.28 10.88 59 176379 73048 79494902
Sarcoidosis 43.16 10.88 71 176367 8264 79559686
Cytokine release syndrome 43.10 10.88 13 176425 35985 79531965
Mycobacterium avium complex infection 43.00 10.88 52 176386 4548 79563402
Lymph node calcification 42.54 10.88 20 176418 395 79567555
Pneumothorax spontaneous 42.45 10.88 31 176407 1423 79566527
Nasal discharge discolouration 42.43 10.88 39 176399 2482 79565468
Eczema 42.40 10.88 191 176247 40627 79527323
Bone marrow failure 41.98 10.88 31 176407 51076 79516874
Bronchiolitis 41.88 10.88 49 176389 4139 79563811
Sepsis 41.62 10.88 388 176050 269040 79298910
Serotonin syndrome 41.48 10.88 24 176414 45003 79522947
Nasal mucosal disorder 41.08 10.88 19 176419 361 79567589
Sinus disorder 40.93 10.88 126 176312 22338 79545612
Premature delivery 40.38 10.88 3 176435 23464 79544486
Neoplasm progression 40.36 10.88 33 176405 51649 79516301
Aortic valve stenosis 40.25 10.88 54 176384 5240 79562710
Intentional self-injury 40.11 10.88 11 176427 32408 79535542
Electrocardiogram QT prolonged 39.78 10.88 88 176350 90298 79477652
FEV1/FVC ratio decreased 39.55 10.88 16 176422 216 79567734
Oesophageal pain 39.39 10.88 48 176390 4231 79563719
Frustration tolerance decreased 38.98 10.88 64 176374 7438 79560512
Oedema peripheral 38.98 10.88 779 175659 251509 79316441
Mycobacterial infection 38.50 10.88 44 176394 3624 79564326
Lung consolidation 38.22 10.88 70 176368 8877 79559073
Sputum increased 38.08 10.88 49 176389 4564 79563386
Cardiogenic shock 37.68 10.88 23 176415 41891 79526059
Hip arthroplasty 37.55 10.88 16 176422 35740 79532210
Inflammation 37.50 10.88 96 176342 93657 79474293
Psoriasis 37.19 10.88 90 176348 89497 79478453
Confusional state 37.17 10.88 488 175950 317509 79250441
Decreased activity 37.11 10.88 68 176370 8626 79559324
Pulmonary congestion 37.01 10.88 138 176300 26962 79540988
Respiratory symptom 36.62 10.88 49 176389 4742 79563208
Skin candida 36.52 10.88 33 176405 2054 79565896
Posterior reversible encephalopathy syndrome 36.34 10.88 7 176431 26274 79541676
Idiopathic intracranial hypertension 36.12 10.88 40 176398 3182 79564768
Laryngeal stenosis 35.92 10.88 25 176413 1063 79566887
Acute respiratory distress syndrome 35.85 10.88 27 176411 44040 79523910
Pyrexia 35.83 10.88 1187 175251 677522 78890428
Liver disorder 35.71 10.88 66 176372 72351 79495599
Paraesthesia 35.57 10.88 236 176202 176087 79391863
Increased upper airway secretion 35.48 10.88 45 176393 4132 79563818
Nocturnal dyspnoea 35.12 10.88 29 176409 1597 79566353
Rhonchi 35.10 10.88 44 176394 3992 79563958
Neurotoxicity 35.04 10.88 14 176424 32504 79535446
Carcinoid tumour pulmonary 34.79 10.88 17 176421 367 79567583
Diastolic dysfunction 34.64 10.88 75 176363 10736 79557214
Illness 34.51 10.88 198 176240 46313 79521637
Poisoning 34.38 10.88 7 176431 25265 79542685
Viral infection 33.82 10.88 186 176252 42830 79525120
Ascites 33.72 10.88 73 176365 75489 79492461
Dyspnoea paroxysmal nocturnal 32.79 10.88 32 176406 2196 79565754
Renal impairment 32.42 10.88 210 176228 157573 79410377
Snoring 32.38 10.88 50 176388 5516 79562434
Dysarthria 32.15 10.88 63 176375 67559 79500391
Drug eruption 31.95 10.88 30 176408 43905 79524045
Joint range of motion decreased 31.73 10.88 17 176421 33265 79534685
Decreased bronchial secretion 31.42 10.88 10 176428 63 79567887
Adverse event 31.39 10.88 53 176385 60161 79507789
Discomfort 31.31 10.88 157 176281 125460 79442490
Sinus pain 31.29 10.88 40 176398 3702 79564248
Neutrophil count decreased 31.20 10.88 105 176333 93854 79474096
Encephalopathy 31.00 10.88 64 176374 67333 79500617
Increased viscosity of bronchial secretion 31.00 10.88 18 176420 556 79567394
Dyskinesia 30.92 10.88 32 176406 44741 79523209
Brain natriuretic peptide abnormal 30.33 10.88 20 176418 777 79567173
Exercise tolerance decreased 30.29 10.88 64 176374 9007 79558943
Drug level increased 30.12 10.88 26 176412 39625 79528325
Increased bronchial secretion 30.11 10.88 37 176401 3290 79564660
Abortion spontaneous 29.74 10.88 14 176424 29493 79538457
Nasal oedema 29.66 10.88 27 176411 1697 79566253
Chest pain 29.57 10.88 826 175612 281478 79286472
Nasal disorder 29.50 10.88 39 176399 3730 79564220
Blood creatine phosphokinase increased 29.36 10.88 64 176374 66026 79501924
Throat tightness 29.29 10.88 131 176307 27776 79540174
Oropharyngeal discomfort 29.27 10.88 55 176383 7111 79560839
Acute hepatic failure 29.27 10.88 15 176423 30098 79537852
Expiratory reserve volume decreased 29.04 10.88 10 176428 83 79567867
Blood alkaline phosphatase increased 28.83 10.88 61 176377 63603 79504347
Pain 28.52 10.88 1270 175168 702532 78865418
Blood lactate dehydrogenase increased 28.19 10.88 27 176411 39143 79528807
Product physical issue 27.79 10.88 40 176398 4145 79563805
Sinus congestion 27.74 10.88 102 176336 19794 79548156
Injection site erythema 27.63 10.88 85 176353 78112 79489838
Blood calcium increased 27.62 10.88 67 176371 10333 79557617
Respiratory distress 27.49 10.88 222 176216 58117 79509833
N-terminal prohormone brain natriuretic peptide abnormal 27.41 10.88 13 176425 262 79567688
Bronchomalacia 27.32 10.88 13 176425 264 79567686
Granulomatous rosacea 27.16 10.88 12 176426 204 79567746
Muscle spasticity 27.11 10.88 7 176431 21468 79546482
Blood immunoglobulin E decreased 27.05 10.88 10 176428 104 79567846
Respiratory arrest 27.03 10.88 54 176384 57496 79510454
Atrial fibrillation 26.96 10.88 600 175838 197286 79370664
Hypoaesthesia 26.95 10.88 260 176178 179092 79388858
Pancreatitis 26.83 10.88 71 176367 68504 79499446
Sputum retention 26.74 10.88 21 176417 1076 79566874
Neurosensory hypoacusis 26.44 10.88 12 176426 218 79567732
Deep vein thrombosis 26.36 10.88 158 176280 120761 79447189
Lipohypertrophy 26.16 10.88 19 176419 865 79567085
Oxygen saturation increased 25.99 10.88 16 176422 551 79567399
Hepatic cytolysis 25.69 10.88 14 176424 27137 79540813
Amnesia 25.66 10.88 64 176374 62993 79504957
Forced expiratory volume abnormal 25.55 10.88 10 176428 123 79567827
Rib fracture 25.54 10.88 126 176312 27821 79540129
Decreased gait velocity 25.39 10.88 11 176427 178 79567772
Normochromic normocytic anaemia 25.21 10.88 54 176384 7673 79560277
Transplant rejection 25.19 10.88 6 176432 19431 79548519
Device dislocation 25.15 10.88 13 176425 25957 79541993
Gout 25.10 10.88 115 176323 24634 79543316
Malignant melanoma in situ 25.04 10.88 29 176409 2423 79565527
Shock 24.92 10.88 36 176402 43512 79524438
Exposure to allergen 24.76 10.88 13 176425 328 79567622
Thrombotic microangiopathy 24.66 10.88 7 176431 20162 79547788
Functional residual capacity increased 24.49 10.88 9 176429 92 79567858
Haemoglobin decreased 24.44 10.88 345 176093 221774 79346176
Klebsiella infection 24.43 10.88 3 176435 15717 79552233
Skin ulcer 24.42 10.88 52 176386 54098 79513852
Bronchitis chronic 24.32 10.88 39 176399 4443 79563507
Hyperbilirubinaemia 24.15 10.88 12 176426 24506 79543444
Suffocation feeling 24.01 10.88 24 176414 1696 79566254
Pneumothorax 23.99 10.88 125 176313 28198 79539752
Cardiac arrest 23.98 10.88 254 176184 171842 79396108
Somnolence 23.95 10.88 378 176060 238603 79329347
Carbon dioxide increased 23.73 10.88 27 176411 2213 79565737
Orthopnoea 23.73 10.88 62 176376 10011 79557939
Product prescribing error 23.59 10.88 175 176263 44638 79523312
Metastases to liver 23.48 10.88 17 176421 28297 79539653
Toxic epidermal necrolysis 23.46 10.88 39 176399 44542 79523408
CFTR gene mutation 23.42 10.88 9 176429 105 79567845
Sarcopenia 23.41 10.88 14 176424 457 79567493
Haemophilus infection 23.38 10.88 27 176411 2249 79565701
Cytopenia 23.27 10.88 8 176430 20375 79547575
Lactic acidosis 23.10 10.88 79 176359 70280 79497670
Prostatic adenoma 23.05 10.88 9 176429 110 79567840
Peritonitis 23.03 10.88 17 176421 28019 79539931
Convulsive threshold lowered 22.81 10.88 18 176420 929 79567021
Rash maculo-papular 22.75 10.88 57 176381 56021 79511929
Proteinuria 22.70 10.88 23 176415 32479 79535471
Colitis ulcerative 22.69 10.88 26 176412 34716 79533234
Drug interaction 22.60 10.88 723 175715 414460 79153490
Acute myeloid leukaemia 22.56 10.88 21 176417 30864 79537086
Nasal septum deviation 22.30 10.88 24 176414 1849 79566101
Eosinophilic pneumonia chronic 22.18 10.88 14 176424 504 79567446
Hallucination, auditory 22.15 10.88 9 176429 20684 79547266
Functional residual capacity decreased 22.01 10.88 8 176430 79 79567871
Laboratory test abnormal 21.79 10.88 18 176420 28030 79539920
Tumour lysis syndrome 21.71 10.88 13 176425 23926 79544024
Lymphocyte count decreased 21.67 10.88 45 176393 47244 79520706
Prescribed underdose 21.64 10.88 20 176418 29494 79538456
Poor quality device used 21.63 10.88 26 176412 2259 79565691
Fractured coccyx 21.60 10.88 18 176420 1004 79566946
Hepatitis 21.57 10.88 58 176380 55669 79512281
Condition aggravated 21.56 10.88 898 175540 500226 79067724
Osteoporosis 21.35 10.88 198 176240 53914 79514036
Oral candidiasis 21.25 10.88 125 176313 29503 79538447
Eye swelling 21.18 10.88 115 176323 26353 79541597
Breath sounds 21.15 10.88 9 176429 139 79567811
Hypothermia 21.13 10.88 12 176426 22734 79545216
Gamma-glutamyltransferase increased 21.10 10.88 57 176381 54623 79513327
Sinusitis 21.01 10.88 574 175864 194927 79373023
Haematocrit decreased 20.71 10.88 68 176370 61244 79506706
Aplastic anaemia 20.49 10.88 7 176431 17898 79550052
Peak expiratory flow rate abnormal 20.47 10.88 8 176430 98 79567852
Sputum culture 20.46 10.88 10 176428 216 79567734
Left ventricular dilatation 20.44 10.88 18 176420 1083 79566867
Factitious disorder 20.42 10.88 9 176429 152 79567798
Cardiac failure congestive 20.42 10.88 435 176003 141967 79425983
Bone erosion 20.38 10.88 7 176431 17840 79550110
Palmar-plantar erythrodysaesthesia syndrome 20.37 10.88 26 176412 33108 79534842
Blood immunoglobulin E abnormal 20.35 10.88 6 176432 28 79567922
Exostosis 20.34 10.88 6 176432 16852 79551098
Eosinophilic bronchitis 20.33 10.88 13 176425 479 79567471
Anaemia 20.31 10.88 792 175646 444223 79123727
Vascular shunt 20.24 10.88 7 176431 59 79567891
Sputum abnormal 20.19 10.88 19 176419 1246 79566704
Multiple drug therapy 20.13 10.88 34 176404 4044 79563906
Device related infection 19.97 10.88 28 176410 34266 79533684
Bronchospasm paradoxical 19.95 10.88 9 176429 161 79567789
Lacrimal disorder 19.93 10.88 13 176425 496 79567454
Pulmonary arterial hypertension 19.91 10.88 119 176319 28247 79539703
Injection site reaction 19.74 10.88 59 176379 54726 79513224
Abdominal pain 19.64 10.88 685 175753 388884 79179066
Epstein-Barr virus infection 19.59 10.88 4 176434 14412 79553538
FEV1/FVC ratio abnormal 19.54 10.88 6 176432 33 79567917
Lip dry 19.51 10.88 5 176433 15413 79552537
Akathisia 19.50 10.88 3 176435 13256 79554694
Aptyalism 19.42 10.88 15 176423 750 79567200
Nasal mucosal discolouration 19.39 10.88 6 176432 34 79567916
Hypochromic anaemia 19.31 10.88 27 176411 2724 79565226
Atheroembolism 19.14 10.88 11 176427 333 79567617
Hypoacusis 18.98 10.88 123 176315 30027 79537923
Tooth disorder 18.97 10.88 18 176420 26215 79541735
Aortic aneurysm 18.89 10.88 51 176387 8395 79559555
Mononeuropathy multiplex 18.87 10.88 12 176426 438 79567512
Lung diffusion disorder 18.73 10.88 9 176429 187 79567763
Joint injury 18.61 10.88 126 176312 31209 79536741
Musculoskeletal discomfort 18.53 10.88 90 176348 19745 79548205
Urinary tract infection 18.50 10.88 464 175974 274048 79293902
Diaphragmatic disorder 18.38 10.88 21 176417 1729 79566221
Vaginal haemorrhage 18.22 10.88 13 176425 21804 79546146
Hyperglycaemia 18.04 10.88 87 176351 70248 79497702
Vision blurred 18.04 10.88 332 176106 105566 79462384
Plasma cell myeloma 18.03 10.88 59 176379 53200 79514750
Device issue 18.02 10.88 20 176418 27088 79540862
Right ventricular systolic pressure 17.99 10.88 5 176433 18 79567932
Diabetic ketoacidosis 17.82 10.88 30 176408 34092 79533858
Respiratory tract inflammation 17.75 10.88 15 176423 853 79567097
Physiotherapy chest 17.70 10.88 4 176434 4 79567946
Pulmonary arterial pressure abnormal 17.65 10.88 14 176424 728 79567222
Flour sensitivity 17.58 10.88 5 176433 20 79567930
Gingival bleeding 17.55 10.88 7 176431 16269 79551681
Sinus polyp degeneration 17.40 10.88 6 176432 50 79567900
Ageusia 17.40 10.88 78 176360 16554 79551396
Myelodysplastic syndrome 17.39 10.88 25 176413 30276 79537674
Electrocardiogram QRS complex abnormal 17.35 10.88 13 176425 621 79567329
Abnormal behaviour 17.25 10.88 34 176404 36387 79531563
Immune thrombocytopenia 17.11 10.88 9 176429 17796 79550154
Urinary retention 17.01 10.88 196 176242 56434 79511516
Colitis 16.93 10.88 94 176344 73213 79494737
Inhalation therapy 16.90 10.88 6 176432 55 79567895
Peripheral venous disease 16.90 10.88 7 176431 15902 79552048
Heavy menstrual bleeding 16.88 10.88 5 176433 14006 79553944
Restlessness 16.80 10.88 50 176388 46442 79521508
Taste disorder 16.74 10.88 7 176431 15816 79552134
Polycystic ovaries 16.69 10.88 30 176408 3749 79564201
Pulmonary pain 16.64 10.88 33 176405 4440 79563510
COVID-19 16.61 10.88 247 176191 157427 79410523
Pneumocystis jirovecii pneumonia 16.59 10.88 29 176409 32479 79535471
Prescribed overdose 16.57 10.88 37 176401 37846 79530104
Hydronephrosis 16.51 10.88 9 176429 17445 79550505
Hyperkaliuria 16.48 10.88 8 176430 170 79567780
Therapy partial responder 16.42 10.88 9 176429 17388 79550562
Musculoskeletal disorder 16.37 10.88 14 176424 21434 79546516
Pneumonia viral 16.34 10.88 51 176387 9107 79558843
Frequent bowel movements 16.34 10.88 25 176413 29514 79538436
Metastases to bone 16.26 10.88 18 176420 24409 79543541
Lung hernia 16.18 10.88 6 176432 63 79567887
Hepatic cirrhosis 16.18 10.88 33 176405 34873 79533077
Osteomyelitis 16.16 10.88 30 176408 32835 79535115
Hypoalbuminaemia 16.13 10.88 14 176424 21283 79546667
Caesarean section 15.99 10.88 4 176434 12531 79555419
Mental status changes 15.94 10.88 85 176353 66874 79501076
Umbilical hernia 15.89 10.88 38 176400 5807 79562143
Eye infection bacterial 15.87 10.88 10 176428 359 79567591
Hepatic haematoma 15.83 10.88 14 176424 847 79567103
Hernia pain 15.80 10.88 11 176427 468 79567482
Pathogen resistance 15.74 10.88 6 176432 14336 79553614
Aspiration 15.74 10.88 87 176351 20071 79547879
Dry throat 15.73 10.88 45 176393 7661 79560289
Acute kidney injury 15.72 10.88 965 175473 518439 79049511
Panniculitis 15.68 10.88 4 176434 12367 79555583
Aphasia 15.66 10.88 52 176386 46680 79521270
Osteoarthritis 15.59 10.88 121 176317 87188 79480762
Hemiparesis 15.54 10.88 32 176406 33701 79534249
Hepatic failure 15.54 10.88 76 176362 61136 79506814
Full blood count decreased 15.51 10.88 22 176416 26797 79541153
Large cell lung cancer metastatic 15.47 10.88 4 176434 10 79567940
Uveitis 15.46 10.88 9 176429 16821 79551129
Joint stiffness 15.42 10.88 43 176395 40787 79527163
Mydriasis 15.42 10.88 10 176428 17633 79550317
Brain oedema 15.34 10.88 20 176418 25243 79542707
Hypomania 15.34 10.88 44 176394 7500 79560450
Diffuse large B-cell lymphoma 15.26 10.88 4 176434 12145 79555805
Cough decreased 15.20 10.88 4 176434 11 79567939
Perennial allergy 15.20 10.88 4 176434 11 79567939
Agranulocytosis 15.17 10.88 50 176388 44980 79522970
Enterobiasis 15.14 10.88 5 176433 36 79567914
Drug withdrawal syndrome 15.11 10.88 34 176404 34684 79533266
Peripheral sensory neuropathy 15.08 10.88 5 176433 13028 79554922
Eye disorder 15.03 10.88 96 176342 23316 79544634
Renal tubular necrosis 15.03 10.88 20 176418 25019 79542931
Drug tolerance decreased 14.98 10.88 5 176433 12973 79554977
Disseminated intravascular coagulation 14.88 10.88 36 176402 35806 79532144
Adverse drug reaction 14.86 10.88 86 176352 66306 79501644
Hypertransaminasaemia 14.84 10.88 4 176434 11920 79556030
Impaired work ability 14.83 10.88 13 176425 19668 79548282
Extrapyramidal disorder 14.78 10.88 17 176421 22662 79545288
Tubulointerstitial nephritis 14.64 10.88 40 176398 38195 79529755
Decreased appetite 14.62 10.88 614 175824 341804 79226146
Upper respiratory tract congestion 14.61 10.88 23 176415 2580 79565370
Muscular weakness 14.54 10.88 259 176179 160470 79407480
Cardiac failure 14.53 10.88 447 175991 154395 79413555
Altered state of consciousness 14.52 10.88 49 176389 43773 79524177
Injury 14.50 10.88 106 176332 77390 79490560
Fluid retention 14.49 10.88 226 176212 69583 79498367
Respiratory tract haemorrhage 14.48 10.88 19 176419 1804 79566146
Bacteraemia 14.40 10.88 32 176406 32792 79535158
Paraneoplastic rash 14.38 10.88 6 176432 88 79567862
Jaundice 14.27 10.88 65 176373 53284 79514666
Torsade de pointes 14.26 10.88 13 176425 19299 79548651
Lung carcinoma cell type unspecified recurrent 14.26 10.88 9 176429 324 79567626
Arthritis 14.25 10.88 174 176264 114706 79453244
Disorientation 14.22 10.88 81 176357 62695 79505255
No adverse event 14.17 10.88 39 176399 37153 79530797
Magnesium metabolism disorder 14.17 10.88 5 176433 45 79567905
Fatigue 14.13 10.88 1822 174616 927905 78640045
Nervousness 14.06 10.88 124 176314 33291 79534659
Dizziness exertional 14.02 10.88 11 176427 563 79567387
Hypophosphataemia 14.01 10.88 14 176424 19899 79548051
Blood uric acid increased 13.99 10.88 6 176432 13354 79554596
Metabolic acidosis 13.98 10.88 116 176322 82413 79485537
Transient ischaemic attack 13.92 10.88 178 176260 52517 79515433
Progressive multifocal leukoencephalopathy 13.91 10.88 15 176423 20585 79547365
Cerebral infarction 13.86 10.88 53 176385 45623 79522327
Blood phosphorus increased 13.80 10.88 3 176435 10344 79557606
Rheumatoid nodule 13.78 10.88 11 176427 17427 79550523
Autoimmune disorder 13.74 10.88 10 176428 16602 79551348
Laryngitis 13.73 10.88 71 176367 15968 79551982
Nasal inflammation 13.72 10.88 12 176426 715 79567235
Pickwickian syndrome 13.71 10.88 10 176428 458 79567492
Bradycardia 13.71 10.88 214 176224 135343 79432607
Dry mouth 13.64 10.88 272 176166 87747 79480203
Affect lability 13.60 10.88 4 176434 11255 79556695
Enterococcal infection 13.52 10.88 9 176429 15651 79552299
Painful respiration 13.48 10.88 26 176412 3427 79564523
Hypercalcaemia 13.41 10.88 42 176396 38388 79529562
Encephalitis 13.41 10.88 8 176430 14752 79553198
Febrile bone marrow aplasia 13.40 10.88 6 176432 13014 79554936
Pneumonitis 13.39 10.88 199 176239 60661 79507289
Sciatica 13.30 10.88 34 176404 33188 79534762
Generalised tonic-clonic seizure 13.29 10.88 51 176387 43859 79524091
Eosinophilic otitis media 13.28 10.88 3 176435 3 79567947
Fractional exhaled nitric oxide increased 13.28 10.88 3 176435 3 79567947
Synovial cyst 13.26 10.88 3 176435 10062 79557888
Pulmonary toxicity 13.21 10.88 6 176432 12908 79555042
Respiratory tract irritation 13.19 10.88 11 176427 614 79567336
Caffeine allergy 13.18 10.88 4 176434 21 79567929
Idiopathic pulmonary fibrosis 13.17 10.88 29 176409 4199 79563751
Forced expiratory volume increased 13.12 10.88 5 176433 57 79567893
Herpes zoster 13.12 10.88 137 176301 92946 79475004
Status epilepticus 13.09 10.88 22 176416 25019 79542931
Ischaemic cardiomyopathy 12.95 10.88 42 176396 7653 79560297
Coagulopathy 12.81 10.88 39 176399 35967 79531983
Foot deformity 12.72 10.88 21 176417 24053 79543897
Colitis microscopic 12.69 10.88 4 176434 10764 79557186
Blood thyroid stimulating hormone abnormal 12.68 10.88 13 176425 947 79567003
Use of accessory respiratory muscles 12.66 10.88 10 176428 517 79567433
Rash papular 12.66 10.88 18 176420 21898 79546052
Brain hypoxia 12.64 10.88 13 176425 950 79567000
Tachyarrhythmia 12.63 10.88 39 176399 6923 79561027
Red blood cell count decreased 12.61 10.88 75 176363 57438 79510512
Immune-mediated pancreatitis 12.60 10.88 8 176430 291 79567659
Mastication disorder 12.58 10.88 22 176416 2691 79565259
Intestinal perforation 12.55 10.88 12 176426 17414 79550536
Underdose 12.46 10.88 35 176403 33116 79534834
Lymphopenia 12.44 10.88 31 176407 30526 79537424
Skin necrosis 12.40 10.88 13 176425 18074 79549876
Squamous cell carcinoma of lung 12.37 10.88 20 176418 2294 79565656
Laryngectomy 12.33 10.88 4 176434 27 79567923
Cardiac failure chronic 12.24 10.88 53 176385 11082 79556868
Intervertebral disc degeneration 12.24 10.88 68 176370 15717 79552233
Small airways disease 12.21 10.88 4 176434 28 79567922
Toxic encephalopathy 12.20 10.88 5 176433 11435 79556515
Ataxia 12.18 10.88 23 176415 25016 79542934
Blood glucose increased 12.14 10.88 180 176258 114795 79453155
Memory impairment 12.12 10.88 174 176264 111560 79456390
Bacterial disease carrier 12.11 10.88 16 176422 1530 79566420
Chronic respiratory failure 12.10 10.88 23 176415 2999 79564951
Lymphoedema 12.09 10.88 57 176381 12356 79555594
Hepatitis acute 12.04 10.88 10 176428 15532 79552418
Ankylosing spondylitis 11.98 10.88 6 176432 12199 79555751
Benign breast neoplasm 11.98 10.88 12 176426 850 79567100
Forced vital capacity abnormal 11.97 10.88 4 176434 30 79567920
Accidental overdose 11.96 10.88 46 176392 39535 79528415
Menopausal symptoms 11.94 10.88 18 176420 1945 79566005
Anal abscess 11.91 10.88 3 176435 9352 79558598
Non-small cell lung cancer 11.89 10.88 36 176402 6324 79561626
Aspirin-exacerbated respiratory disease 11.87 10.88 14 176424 1193 79566757
Hypotension 11.76 10.88 1129 175309 439188 79128762
Abnormal loss of weight 11.73 10.88 43 176395 8333 79559617
Grip strength decreased 11.63 10.88 19 176419 21850 79546100
Hyperammonaemia 11.59 10.88 5 176433 11088 79556862
Metabolic disorder 11.56 10.88 3 176435 9167 79558783
Exposure to toxic agent 11.53 10.88 3 176435 9155 79558795
Pyelonephritis 11.52 10.88 17 176421 20371 79547579
Pulmonary artery dilatation 11.48 10.88 9 176429 460 79567490
Metastases to lung 11.43 10.88 14 176424 18149 79549801
Hepatic necrosis 11.42 10.88 3 176435 9097 79558853
Croup infectious 11.39 10.88 11 176427 745 79567205
Fibromuscular dysplasia 11.37 10.88 7 176431 241 79567709
Poisoning deliberate 11.34 10.88 15 176423 18813 79549137
Anxiety 11.33 10.88 665 175773 247847 79320103
Sensory disturbance 11.31 10.88 10 176428 15067 79552883
Hyposmia 11.28 10.88 11 176427 754 79567196
Choking sensation 11.28 10.88 26 176412 3880 79564070
Hallucination, visual 11.26 10.88 36 176402 32693 79535257
Crepitations 11.26 10.88 48 176390 9969 79557981
Graft versus host disease 11.23 10.88 10 176428 15016 79552934
Lung adenocarcinoma stage II 11.21 10.88 3 176435 9 79567941
Major depression 11.20 10.88 3 176435 8977 79558973
Breast neoplasm 11.20 10.88 12 176426 920 79567030
Occupational exposure to air contaminants 11.20 10.88 6 176432 158 79567792
Cholecystitis chronic 11.11 10.88 4 176434 9902 79558048
Oxygen consumption increased 11.07 10.88 30 176408 4949 79563001
Wrist fracture 11.07 10.88 54 176384 11867 79556083
Anhedonia 11.04 10.88 10 176428 14888 79553062
Lip blister 11.01 10.88 21 176417 2746 79565204
Serum ferritin increased 11.01 10.88 4 176434 9843 79558107
Schizophrenia 10.98 10.88 65 176373 15375 79552575
Xanthelasma 10.96 10.88 6 176432 165 79567785
Pneumonectomy 10.91 10.88 5 176433 93 79567857
Lower gastrointestinal haemorrhage 10.90 10.88 67 176371 16058 79551892

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R03AL06 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03AL10 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03BB04 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Anticholinergics
ATC R03BB54 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Anticholinergics
FDA MoA N0000175370 Cholinergic Antagonists
FDA EPC N0000175574 Anticholinergic
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D001993 Bronchodilator Agents
MeSH PA D018678 Cholinergic Agents
MeSH PA D018680 Cholinergic Antagonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D010276 Parasympatholytics
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D019141 Respiratory System Agents
CHEBI has role CHEBI:35523 bronchodilator
CHEBI has role CHEBI:48876 muscarinic antagonists

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

DiseaseRelationSNOMED_IDDOID
Chronic bronchitis indication 63480004 DOID:6132
Pulmonary emphysema indication 87433001
Asthma indication 195967001 DOID:2841
Bronchospasm Prevention with COPD indication
Chronic Obstructive Pulmonary Disease with Bronchospasms indication
Impaired renal function disorder contraindication 197663003
Bladder outflow obstruction contraindication 236645006
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.97 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH STIOLTO RESPIMAT BOEHRINGER INGELHEIM N206756 May 21, 2015 RX SPRAY, METERED INHALATION 8044046 Nov. 10, 2023 TREATMENT OF COPD
EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH STIOLTO RESPIMAT BOEHRINGER INGELHEIM N206756 May 21, 2015 RX SPRAY, METERED INHALATION 7220742 May 12, 2025 TREATMENT OF RESPIRATORY COMPLAINTS
EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH STIOLTO RESPIMAT BOEHRINGER INGELHEIM N206756 May 21, 2015 RX SPRAY, METERED INHALATION 8034809 May 12, 2025 TREATMENT OF COPD
EQ 0.018MG BASE/INH SPIRIVA BOEHRINGER INGELHEIM N021395 Jan. 30, 2004 RX POWDER INHALATION 8022082 Jan. 19, 2026 ADMINISTRATION OF AN INHALABLE POWDER COMPRISING TIOTROPIUM VIA DEVICE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Muscarinic acetylcholine receptor M3 GPCR ANTAGONIST Ki 11.10 WOMBAT-PK CHEMBL
Muscarinic acetylcholine receptor M2 GPCR Ki 11 WOMBAT-PK
Muscarinic acetylcholine receptor M4 GPCR Ki 11 WOMBAT-PK
Muscarinic acetylcholine receptor M5 GPCR Ki 11 WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR Ki 11 WOMBAT-PK
Muscarinic acetylcholine receptor M2 GPCR Ki 9.82 CHEMBL
Muscarinic acetylcholine receptor M1 GPCR Ki 9.80 CHEMBL
Muscarinic acetylcholine receptor M3 GPCR Ki 9.52 CHEMBL

External reference:

IDSource
4021416 VUID
N0000148830 NUI
411207-31-3 SECONDARY_CAS_RN
4021416 VANDF
CHEBI:90959 CHEBI
0HK PDB_CHEM_ID
CHEMBL3545181 ChEMBL_ID
CHEMBL1900528 ChEMBL_ID
CHEMBL1182657 ChEMBL_ID
367 IUPHAR_LIGAND_ID
DB01409 DRUGBANK_ID
1298831 RXNORM
17045 MMSL
31060 MMSL
45574 MMSL
d04829 MMSL
009712 NDDF
009713 NDDF
407730002 SNOMEDCT_US
409169006 SNOMEDCT_US
425812008 SNOMEDCT_US
734451000 SNOMEDCT_US
C1306772 UMLSCUI
D000069447 MESH_DESCRIPTOR_UI
5487426 PUBCHEM_CID
0EB439235F UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Spiriva HandiHaler HUMAN PRESCRIPTION DRUG LABEL 1 0597-0075 CAPSULE 18 ug ORAL NDA 30 sections
Stiolto Respimat HUMAN PRESCRIPTION DRUG LABEL 2 0597-0155 SPRAY, METERED 3.12 ug RESPIRATORY (INHALATION) NDA 31 sections
Stiolto Respimat HUMAN PRESCRIPTION DRUG LABEL 2 0597-0155 SPRAY, METERED 3.12 ug RESPIRATORY (INHALATION) NDA 31 sections
Spiriva HandiHaler HUMAN PRESCRIPTION DRUG LABEL 1 50090-4248 CAPSULE 18 ug ORAL NDA 29 sections
Spiriva HandiHaler HUMAN PRESCRIPTION DRUG LABEL 1 50090-4248 CAPSULE 18 ug ORAL NDA 29 sections
Spiriva HUMAN PRESCRIPTION DRUG LABEL 1 50090-4414 CAPSULE 18 ug ORAL NDA 29 sections
Spiriva HUMAN PRESCRIPTION DRUG LABEL 1 54868-5109 CAPSULE 18 ug ORAL NDA 29 sections
Tiotropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 68180-964 CAPSULE 18 ug ORAL ANDA 24 sections