ipratropium 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
atropine derivatives 1475 60205-81-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ipratropium
  • ipratropium bromide
  • ipratropium bromide hydrate
  • ipratropium bromide monohydrate
A muscarinic antagonist structurally related to ATROPINE but often considered safer and more effective for inhalation use. It is used for various bronchial disorders, in rhinitis, and as an antiarrhythmic.
  • Molecular weight: 332.46
  • Formula: C20H30NO3
  • CLOGP: -2.19
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 46.53
  • ALOGS: -5.48
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.24 mg N
0.12 mg Inhal.aerosol
0.12 mg Inhal.powder
0.30 mg Inhal.solution

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.01 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 3 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 5.10 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 31.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.95 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.64 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -1.864 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.277 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.462 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 3.126 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 89.290 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 62.080 % High 1
herg hERG pIC50 4.147 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 2.128 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.243 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 81.780 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAPK7,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK,TGFBR1 22
kinase-selectivity-class EIF2AK3 1
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.545 Moderate 0.66
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.447 High 1
mh-clint Mouse hepatocyte intrinsic clearance 65.313 High 1
mppb Mouse plasma protein binding (% unbound) 84.990 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.491 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
pppb Pig plasma protein binding (% unbound) 81.080 % High 1
rat-kpuu-brain Rat brain Kpuu 0.003 % Moderate 0.66
rh-clint Rat hepatocyte intrinsic clearance 21.135 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 91.080 % High 1
rppb Rat plasma protein binding (% unbound) 69.560 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 860.994 uM High 1

Approvals:

DateAgencyCompanyOrphan
Dec. 29, 1986 FDA

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
Asthma 1255.67 10.54 1222 69497 240938 90316790
Obstructive airways disorder 800.87 10.54 395 70324 25474 90532254
Chronic obstructive pulmonary disease 772.97 10.54 560 70159 73269 90484459
Wheezing 651.49 10.54 863 69856 237217 90320511
Dyspnoea 593.16 10.54 1763 68956 879192 89678536
Cough 395.87 10.54 882 69837 368080 90189648
Bronchiectasis 342.94 10.54 215 70504 22115 90535613
Productive cough 325.44 10.54 349 70370 76714 90481014
Pneumonia 312.79 10.54 1149 69570 636910 89920818
Asthma-chronic obstructive pulmonary disease overlap syndrome 300.95 10.54 121 70598 4778 90552950
Total lung capacity increased 287.81 10.54 118 70601 4903 90552825
Cardiac murmur 271.42 10.54 172 70547 18022 90539706
Sleep disorder due to a general medical condition 257.90 10.54 240 70479 44498 90513230
Full blood count abnormal 247.83 10.54 215 70504 36382 90521346
Nasal polyps 244.30 10.54 134 70585 10746 90546982
Chest discomfort 240.35 10.54 406 70313 137959 90419769
Synovitis 233.06 10.54 5 70714 329747 90227981
Rhinitis allergic 226.52 10.54 149 70570 16636 90541092
Systemic lupus erythematosus 220.97 10.54 16 70703 361880 90195848
Pemphigus 219.79 10.54 8 70711 326856 90230872
Glossodynia 215.94 10.54 8 70711 321771 90235957
Hand deformity 215.59 10.54 3 70716 296359 90261369
Sarcoidosis 213.91 10.54 122 70597 10551 90547177
Sputum discoloured 213.89 10.54 155 70564 20236 90537492
Contraindicated product administered 201.78 10.54 12 70707 320127 90237601
Rales 200.32 10.54 135 70584 15692 90542036
Alopecia 195.75 10.54 71 70648 495000 90062728
Drug intolerance 195.07 10.54 54 70665 447537 90110191
Nasal congestion 183.80 10.54 273 70446 83141 90474587
Arthropathy 182 10.54 33 70686 366209 90191519
Blood test abnormal 181.42 10.54 142 70577 20810 90536918
Pericarditis 170.61 10.54 10 70709 270141 90287587
Wound 169.85 10.54 19 70700 302961 90254767
Bronchopulmonary aspergillosis allergic 164.49 10.54 73 70646 3693 90554035
Infusion related reaction 162.63 10.54 61 70658 416719 90141009
Treatment failure 158.51 10.54 24 70695 303904 90253824
Dyspnoea exertional 156.97 10.54 235 70484 72053 90485675
Total lung capacity decreased 151.24 10.54 69 70650 3726 90554002
Lung neoplasm malignant 149.17 10.54 135 70584 24138 90533590
Helicobacter infection 147.61 10.54 7 70712 226843 90330885
Folliculitis 144.71 10.54 3 70716 204350 90353378
Anti-cyclic citrullinated peptide antibody positive 142.69 10.54 11 70708 236422 90321306
Jaundice cholestatic 142.48 10.54 92 70627 9951 90547777
Haemoptysis 137.24 10.54 149 70570 33171 90524557
Gastrooesophageal reflux disease 136.40 10.54 359 70360 165978 90391750
Hypomania 134.91 10.54 85 70634 8812 90548916
Respiratory failure 133.21 10.54 289 70430 118129 90439599
Joint swelling 132.18 10.54 119 70600 503181 90054547
Lung opacity 131.08 10.54 73 70646 6029 90551699
Maternal exposure during pregnancy 130.23 10.54 59 70660 360004 90197724
Middle insomnia 128.99 10.54 106 70613 16645 90541083
Psoriatic arthropathy 126.24 10.54 15 70704 228320 90329408
Breath sounds abnormal 126.16 10.54 101 70618 15285 90542443
Rheumatoid arthritis 125.66 10.54 63 70656 362551 90195177
Loss of personal independence in daily activities 122.19 10.54 304 70415 135801 90421927
Hypoxia 119.76 10.54 208 70511 72191 90485537
Abdominal discomfort 118.14 10.54 119 70600 477209 90080519
Irritable bowel syndrome 113.76 10.54 14 70705 207434 90350294
Sleep apnoea syndrome 113.70 10.54 132 70587 31615 90526113
Impaired healing 110.21 10.54 24 70695 234175 90323553
Blood calcium increased 107.15 10.54 83 70636 11975 90545753
Discomfort 105.52 10.54 41 70678 274294 90283434
Swelling 104.21 10.54 104 70615 418954 90138774
Aspiration 103.81 10.54 91 70628 15602 90542126
Schizophrenia 103.74 10.54 89 70630 14825 90542903
Bronchial neoplasm 103.25 10.54 31 70688 499 90557229
Oedema peripheral 102.70 10.54 436 70283 257479 90300249
Rhinitis 100.58 10.54 84 70635 13488 90544240
Nasal turbinate hypertrophy 97.86 10.54 34 70685 887 90556841
Bronchial haemorrhage 96.87 10.54 31 70688 622 90557106
Blister 96.61 10.54 39 70680 254959 90302769
Upper-airway cough syndrome 96.59 10.54 86 70633 15049 90542679
Therapeutic product effect decreased 94.97 10.54 49 70670 277522 90280206
Rhonchi 90.69 10.54 45 70674 2933 90554795
Liver injury 89.96 10.54 13 70706 170554 90387174
Completed suicide 89.65 10.54 6 70713 145052 90412676
Eosinophilia 89.65 10.54 111 70608 28422 90529306
Respiration abnormal 89.17 10.54 63 70656 7900 90549828
Prolonged expiration 87.54 10.54 34 70685 1223 90556505
Hyper IgE syndrome 87.53 10.54 27 70692 478 90557250
Toxic epidermal necrolysis 87.23 10.54 117 70602 32411 90525317
Therapeutic product effect incomplete 86.84 10.54 340 70379 193556 90364172
Restrictive pulmonary disease 84.95 10.54 40 70679 2322 90555406
Blood immunoglobulin E increased 84.45 10.54 49 70670 4376 90553352
Sleep disorder due to general medical condition, insomnia type 83.60 10.54 4 70715 128690 90429038
Bronchitis 83.52 10.54 286 70433 152641 90405087
Endometrial ablation 83.07 10.54 31 70688 998 90556730
C-reactive protein abnormal 82.65 10.54 4 70715 127425 90430303
Bronchospasm 82.48 10.54 91 70628 20618 90537110
Forced expiratory volume decreased 81.88 10.54 53 70666 5755 90551973
Ventricular failure 81.38 10.54 24 70695 362 90557366
Acute respiratory failure 81.24 10.54 131 70588 42787 90514941
Oxygen saturation decreased 80.06 10.54 224 70495 107259 90450469
Heart sounds 79.87 10.54 31 70688 1113 90556615
Vocal cord dysfunction 79.17 10.54 29 70690 885 90556843
Myocardial infarction 77.12 10.54 219 70500 105753 90451975
Upper respiratory tract infection 76.31 10.54 247 70472 128071 90429657
Rash 75.04 10.54 343 70376 795757 89761971
Oesophageal spasm 74.36 10.54 41 70678 3320 90554408
Bronchial disorder 74.03 10.54 32 70687 1518 90556210
Hypercapnia 72.86 10.54 52 70667 6625 90551103
Exposure during pregnancy 71.80 10.54 49 70670 238361 90319367
Intentional product use issue 71.66 10.54 40 70679 216852 90340876
Off label use 71.37 10.54 536 70183 1101716 89456012
Gastrointestinal disorder 70.56 10.54 58 70661 256629 90301099
Joint range of motion decreased 70.00 10.54 11 70708 135632 90422096
Drug ineffective 69.06 10.54 720 69999 1383578 89174150
Toxicity to various agents 67.50 10.54 75 70644 287771 90269957
Mobility decreased 67.27 10.54 58 70661 250676 90307052
Arthralgia 66.09 10.54 348 70371 778174 89779554
Product use issue 65.94 10.54 97 70622 329822 90227906
Psychotic disorder 64.19 10.54 99 70620 31131 90526597
Oesophageal pain 61.87 10.54 40 70679 4334 90553394
Rib deformity 61.63 10.54 18 70701 262 90557466
Pulmonary mass 60.25 10.54 92 70627 28680 90529048
Dysphonia 59.86 10.54 144 70575 62940 90494788
Stomatitis 59.68 10.54 76 70643 274622 90283106
Tachypnoea 59.21 10.54 78 70641 21231 90536497
Laryngeal stenosis 58.62 10.54 26 70693 1313 90556415
Epidermal necrosis 58.36 10.54 31 70688 2330 90555398
Liver disorder 57.90 10.54 12 70707 121257 90436471
Bursitis 57.03 10.54 16 70703 131638 90426090
Pleuritic pain 56.20 10.54 54 70665 10407 90547321
Impaired quality of life 55.67 10.54 79 70640 23065 90534663
Blood cholesterol increased 54.72 10.54 49 70670 207963 90349765
Throat clearing 53.97 10.54 35 70684 3812 90553916
Cardiac failure congestive 53.35 10.54 184 70535 98510 90459218
Lip dry 52.52 10.54 8 70711 100947 90456781
Hepatic enzyme increased 52.00 10.54 129 70590 360607 90197121
Breast conserving surgery 51.85 10.54 23 70696 1162 90556566
Respiratory rate increased 51.47 10.54 63 70656 15938 90541790
PO2 decreased 51.46 10.54 25 70694 1556 90556172
Sinus tachycardia 51.21 10.54 85 70634 28428 90529300
Blood bilirubin increased 51.04 10.54 108 70611 43362 90514366
Pain 50.84 10.54 515 70204 995826 89561902
Respiratory distress 50.73 10.54 101 70618 38845 90518883
Heart rate increased 50.53 10.54 198 70521 112704 90445024
Tremor 50.48 10.54 245 70474 152928 90404800
Inflammation 49.50 10.54 40 70679 178552 90379176
Cholelithiasis 48.90 10.54 119 70600 52387 90505341
Pneumonia viral 48.27 10.54 46 70673 8777 90548951
Sinus disorder 48.11 10.54 92 70627 34355 90523373
Prescribed overdose 47.99 10.54 9 70710 97616 90460112
Red blood cell sedimentation rate increased 46.69 10.54 5 70714 82590 90475138
Hypoaesthesia 46.35 10.54 111 70608 314099 90243629
Emphysema 45.98 10.54 52 70667 12103 90545625
Hip arthroplasty 44.69 10.54 4 70715 76204 90481524
Venous pressure jugular increased 44.54 10.54 17 70702 583 90557145
Lymphoedema 44.00 10.54 54 70665 13699 90544029
PCO2 increased 43.45 10.54 21 70698 1292 90556436
Sight disability 43.21 10.54 12 70707 144 90557584
Granuloma 43.20 10.54 37 70682 6148 90551580
Influenza 42.52 10.54 218 70501 139046 90418682
Wound infection 42.39 10.54 15 70704 106387 90451341
Nasal obstruction 42.24 10.54 26 70693 2586 90555142
Eosinophil count abnormal 41.76 10.54 18 70701 848 90556880
Gait inability 41.60 10.54 32 70687 146424 90411304
Transaminases increased 40.91 10.54 90 70629 37102 90520626
Musculoskeletal pain 40.81 10.54 44 70675 171207 90386521
Peripheral venous disease 40.69 10.54 8 70711 83913 90473815
C-reactive protein increased 40.62 10.54 49 70670 181340 90376388
Hypercholesterolaemia 40.58 10.54 14 70705 100878 90456850
Thermohypoaesthesia 40.40 10.54 11 70708 122 90557606
Influenza B virus test positive 39.80 10.54 13 70706 279 90557449
Rhinorrhoea 39.60 10.54 155 70564 88161 90469567
Lower limb fracture 39.38 10.54 9 70710 85004 90472724
Lung hyperinflation 39.13 10.54 20 70699 1388 90556340
Rash papular 38.33 10.54 62 70657 20293 90537435
Pulmonary hypertension 38.14 10.54 95 70624 42428 90515300
Atrial fibrillation 37.94 10.54 205 70514 133406 90424322
Status asthmaticus 37.90 10.54 17 70702 882 90556846
Affective disorder 37.72 10.54 38 70681 7755 90549973
Depressive symptom 37.70 10.54 32 70687 5253 90552475
Adverse event 36.87 10.54 23 70696 117395 90440333
Pleural effusion 36.80 10.54 179 70540 111812 90445916
Hyperlipidaemia 36.79 10.54 65 70654 22851 90534877
Peripheral swelling 35.88 10.54 183 70536 412923 90144805
Analgesic therapy 35.83 10.54 15 70704 657 90557071
Autoimmune disorder 35.80 10.54 8 70711 76736 90480992
Infective pulmonary exacerbation of cystic fibrosis 35.57 10.54 42 70677 10237 90547491
Respiratory gas exchange disorder 35.51 10.54 13 70706 396 90557332
Blood creatinine increased 35.45 10.54 165 70554 101221 90456507
Coronary artery disease 35.45 10.54 80 70639 33543 90524185
Reversible airways obstruction 35.32 10.54 21 70698 1962 90555766
Infective exacerbation of chronic obstructive airways disease 35.29 10.54 19 70700 1467 90556261
Nail disorder 34.91 10.54 3 70716 59064 90498664
Hypersensitivity 34.81 10.54 210 70509 454467 90103261
Hepatotoxicity 34.57 10.54 96 70623 45746 90511982
Knee arthroplasty 34.40 10.54 11 70708 83171 90474557
Night sweats 34.25 10.54 30 70689 128736 90428992
Antacid therapy 34.17 10.54 15 70704 739 90556989
Appendicolith 34.03 10.54 15 70704 746 90556982
Drug therapy 33.15 10.54 15 70704 794 90556934
Multimorbidity 33.13 10.54 14 70705 628 90557100
Anticoagulant therapy 33.01 10.54 15 70704 802 90556926
Dyslipidaemia 32.84 10.54 40 70679 10067 90547661
Appetite disorder 32.74 10.54 38 70681 9095 90548633
Blepharospasm 32.27 10.54 3 70716 55442 90502286
Drug abuse 32.14 10.54 12 70707 82335 90475393
Bundle branch block left 32.00 10.54 35 70684 7850 90549878
Skin lesion 31.97 10.54 82 70637 37283 90520445
Lactose intolerance 31.71 10.54 24 70695 3345 90554383
Airway peak pressure increased 31.59 10.54 12 70707 406 90557322
Frequent bowel movements 30.81 10.54 4 70715 56931 90500797
Blood insulin abnormal 30.75 10.54 7 70712 34 90557694
Presyncope 30.59 10.54 73 70646 31732 90525996
Pulmonary oedema 30.34 10.54 112 70607 61968 90495760
Sciatica 30.28 10.54 21 70698 101361 90456367
Kyphosis 30.25 10.54 22 70697 2886 90554842
Polycystic ovaries 30.02 10.54 29 70690 5625 90552103
Crystal arthropathy 29.90 10.54 11 70708 340 90557388
Lactic acidosis 29.85 10.54 97 70622 50366 90507362
Cyanosis 29.71 10.54 54 70665 19401 90538327
FEV1/FVC ratio decreased 29.04 10.54 9 70710 162 90557566
Epilepsy 28.86 10.54 14 70705 82192 90475536
Respiratory tract infection 28.38 10.54 106 70613 58972 90498756
Ill-defined disorder 28.30 10.54 64 70655 184827 90372901
Blood pH decreased 28.09 10.54 20 70699 2538 90555190
Fibromyalgia 27.98 10.54 76 70643 206193 90351535
Decreased appetite 27.72 10.54 176 70543 376364 90181364
Taste disorder 27.56 10.54 7 70712 61539 90496189
Prescribed underdose 27.54 10.54 12 70707 75007 90482721
Road traffic accident 27.52 10.54 26 70693 107600 90450128
Lung neoplasm 27.52 10.54 30 70689 6705 90551023
Injury 27.30 10.54 72 70647 197277 90360451
Aortic stenosis 27.25 10.54 29 70690 6307 90551421
Pneumococcal infection 27.03 10.54 15 70704 1230 90556498
Bronchospasm paradoxical 26.92 10.54 8 70711 124 90557604
Haematoma 26.75 10.54 79 70640 38969 90518759
Separation anxiety disorder 26.73 10.54 6 70713 27 90557701
Respiratory acidosis 26.17 10.54 32 70687 8087 90549641
Intentional overdose 26.01 10.54 21 70698 93813 90463915
Asthmatic crisis 25.87 10.54 17 70702 1893 90555835
Tracheomalacia 25.56 10.54 10 70709 367 90557361
Rectal prolapse 25.53 10.54 18 70701 2249 90555479
Pulmonary embolism 25.37 10.54 182 70537 130638 90427090
Unresponsive to stimuli 25.05 10.54 76 70643 38045 90519683
Chest X-ray abnormal 25.00 10.54 25 70694 5057 90552671
Blood bicarbonate decreased 24.56 10.54 20 70699 3099 90554629
Respiratory disorder 24.53 10.54 108 70611 64708 90493020
Lower respiratory tract infection 24.43 10.54 301 70418 250358 90307370
Psoriasis 24.40 10.54 49 70670 147705 90410023
Heparin-induced thrombocytopenia 24.07 10.54 25 70694 5287 90552441
Pulmonary function test decreased 23.77 10.54 23 70696 4471 90553257
Hyperphosphataemia 23.51 10.54 21 70698 3690 90554038
Acute generalised exanthematous pustulosis 23.47 10.54 40 70679 13663 90544065
Confusional state 22.89 10.54 192 70527 386013 90171715
Coeliac disease 22.16 10.54 4 70715 44606 90513122
Diarrhoea 22.15 10.54 561 70158 938629 89619099
Frustration tolerance decreased 22.09 10.54 29 70690 7867 90549861
Obesity 22.06 10.54 30 70689 105477 90452251
Brain hypoxia 21.59 10.54 10 70709 559 90557169
Upper airway obstruction 21.22 10.54 12 70707 1020 90556708
Blood lactic acid increased 21.16 10.54 30 70689 8748 90548980
Agitation 21.14 10.54 106 70613 66992 90490736
Eye pruritus 21.11 10.54 60 70659 28967 90528761
Drug hypersensitivity 20.99 10.54 246 70473 463363 90094365
Respiratory alkalosis 20.83 10.54 19 70700 3429 90554299
Amaurosis 20.80 10.54 11 70708 819 90556909
Staphylococcus test positive 20.69 10.54 21 70698 4324 90553404
Bronchial hyperreactivity 20.45 10.54 15 70704 1993 90555735
Premature delivery 20.32 10.54 3 70716 38759 90518969
Exostosis 20.31 10.54 8 70711 53126 90504602
Oropharyngeal pain 19.93 10.54 156 70563 115031 90442697
Nasal discharge discolouration 19.79 10.54 17 70702 2836 90554892
Decreased activity 19.75 10.54 28 70691 8164 90549564
Acute myocardial infarction 19.68 10.54 66 70653 34824 90522904
Peak expiratory flow rate abnormal 19.62 10.54 6 70713 103 90557625
Therapy non-responder 19.58 10.54 49 70670 136655 90421073
Injection site reaction 19.44 10.54 26 70693 92054 90465674
Angina pectoris 19.43 10.54 71 70648 39089 90518639
Upper respiratory tract irritation 19.29 10.54 7 70712 208 90557520
Activated partial thromboplastin time prolonged 19.25 10.54 27 70692 7798 90549930
Hepatic cirrhosis 19.02 10.54 13 70706 63240 90494488
Hypoventilation 18.92 10.54 22 70697 5274 90552454
Abscess 18.86 10.54 44 70675 18847 90538881
Anaemia 18.84 10.54 383 70336 352419 90205309
Tinnitus 18.79 10.54 75 70644 43027 90514701
Joint stiffness 18.64 10.54 20 70699 78022 90479706
Flank pain 18.36 10.54 44 70675 19178 90538550
Idiopathic intracranial hypertension 18.33 10.54 18 70701 3563 90554165
Pneumonia respiratory syncytial viral 18.24 10.54 12 70707 1339 90556389
Sputum purulent 18.23 10.54 12 70707 1340 90556388
Hepatitis 18.19 10.54 17 70702 70722 90487006
Pneumonia staphylococcal 18.07 10.54 18 70701 3623 90554105
Breathing-related sleep disorder 17.98 10.54 6 70713 138 90557590
Humidity intolerance 17.89 10.54 8 70711 412 90557316
Optic ischaemic neuropathy 17.65 10.54 13 70706 1739 90555989
Pupillary reflex impaired 17.32 10.54 15 70704 2530 90555198
Oesophageal motility disorder 17.19 10.54 9 70710 657 90557071
Hiatus hernia 17.08 10.54 51 70668 25310 90532418
Myocardial ischaemia 17.00 10.54 35 70684 13779 90543949
Forced expiratory volume increased 16.92 10.54 5 70714 76 90557652
Nephrocalcinosis 16.77 10.54 11 70708 1221 90556507
Ankle fracture 16.70 10.54 44 70675 20326 90537402
Oedema 16.65 10.54 90 70629 200205 90357523
Basal cell carcinoma 16.57 10.54 3 70716 33386 90524342
Joint dislocation 16.57 10.54 7 70712 44575 90513153
Sneezing 16.40 10.54 56 70663 29813 90527915
Back injury 16.27 10.54 8 70711 46614 90511114
Dystrophic calcification 16.23 10.54 6 70713 188 90557540
Disease progression 16.20 10.54 65 70654 156550 90401178
Oesophageal irritation 16.16 10.54 7 70712 334 90557394
Infusion site erythema 16.08 10.54 34 70685 13636 90544092
Restless legs syndrome 15.91 10.54 46 70673 22424 90535304
Secretion discharge 15.85 10.54 37 70682 15859 90541869
Chondrocalcinosis pyrophosphate 15.77 10.54 10 70709 1048 90556680
Contusion 15.74 10.54 123 70596 251093 90306635
Foot deformity 15.74 10.54 14 70705 59637 90498091
Blood albumin decreased 15.55 10.54 38 70681 16765 90540963
Gout 15.47 10.54 38 70681 16821 90540907
Aortic aneurysm 15.34 10.54 18 70701 4357 90553371
Extensor plantar response 15.31 10.54 11 70708 1416 90556312
Diverticulum 15.28 10.54 31 70688 12082 90545646
Seasonal allergy 15.27 10.54 46 70673 22937 90534791
Oropharyngeal discomfort 15.17 10.54 24 70695 7711 90550017
Musculoskeletal stiffness 15.14 10.54 153 70566 296379 90261349
Dry mouth 15.14 10.54 83 70636 183976 90373752
Underdose 15.08 10.54 12 70707 54005 90503723
Feeling abnormal 15.08 10.54 198 70521 167037 90390691
Drug ineffective for unapproved indication 14.92 10.54 18 70701 66626 90491102
Colitis ulcerative 14.89 10.54 15 70704 60251 90497477
Neuromyelitis optica spectrum disorder 14.88 10.54 11 70708 1479 90556249
Bacterial infection 14.72 10.54 46 70673 23398 90534330
Vascular parkinsonism 14.71 10.54 5 70714 122 90557606
Peak expiratory flow rate decreased 14.67 10.54 8 70711 634 90557094
Cardiomegaly 14.63 10.54 40 70679 18885 90538843
Glycosylated haemoglobin decreased 14.59 10.54 8 70711 641 90557087
Emotional distress 14.57 10.54 62 70657 36600 90521128
Terminal insomnia 14.51 10.54 10 70709 1205 90556523
Pneumonia pseudomonal 14.38 10.54 15 70704 3188 90554540
Speech disorder 14.35 10.54 72 70647 45513 90512215
Tachycardia 14.35 10.54 187 70532 157486 90400242
Eczema 14.25 10.54 80 70639 52790 90504938
Lacrimation increased 14.22 10.54 50 70669 27012 90530716
Blood glucose abnormal 14.06 10.54 26 70693 9466 90548262
Muscle spasticity 14.03 10.54 5 70714 35317 90522411
Cardiac disorder 13.99 10.54 84 70635 56788 90500940
Laryngospasm 13.89 10.54 15 70704 3318 90554410
Idiopathic angioedema 13.84 10.54 4 70715 56 90557672
Anaphylactic reaction 13.76 10.54 116 70603 87408 90470320
Eosinophil count increased 13.65 10.54 31 70688 13050 90544678
Viral infection 13.45 10.54 66 70653 41348 90516380
Pneumonitis 13.37 10.54 69 70650 44101 90513627
Microcephaly 13.34 10.54 10 70709 1374 90556354
Hepatic function abnormal 13.28 10.54 10 70709 46278 90511450
Infusion site pruritus 13.28 10.54 21 70698 6744 90550984
Pharyngeal mass 13.25 10.54 6 70713 318 90557410
Stress cardiomyopathy 13.22 10.54 31 70688 13324 90544404
Pulmonary pain 13.11 10.54 18 70701 5096 90552632
Memory impairment 13.10 10.54 95 70624 197149 90360579
Inspiratory capacity decreased 13.06 10.54 4 70715 69 90557659
Eating disorder 12.94 10.54 3 70716 28070 90529658
Hepatic cytolysis 12.94 10.54 4 70715 30912 90526816
Hypertrophic cardiomyopathy 12.92 10.54 12 70707 2216 90555512
Barrett's oesophagus 12.82 10.54 7 70712 556 90557172
Drug resistance 12.64 10.54 4 70715 30445 90527283
Visceral pain 12.51 10.54 3 70716 19 90557709
Drug eruption 12.47 10.54 6 70713 35401 90522327
Angle closure glaucoma 12.47 10.54 13 70706 2762 90554966
Burn oral cavity 12.44 10.54 5 70714 197 90557531
Stress 12.34 10.54 107 70612 81288 90476440
Blood phosphorus increased 12.30 10.54 16 70703 4302 90553426
Chronic kidney disease 12.26 10.54 74 70645 50117 90507611
Acute kidney injury 12.23 10.54 332 70387 320055 90237673
Product dose omission issue 12.22 10.54 306 70413 291381 90266347
Cardiac failure 12.21 10.54 135 70584 109361 90448367
Tracheitis 12.09 10.54 8 70711 902 90556826
Circumstance or information capable of leading to medication error 12.01 10.54 17 70702 4950 90552778
Presbyopia 11.98 10.54 7 70712 633 90557095
General physical health deterioration 11.93 10.54 200 70519 354915 90202813
Blood urea abnormal 11.90 10.54 8 70711 926 90556802
Orthopnoea 11.77 10.54 20 70699 6815 90550913
Cor pulmonale 11.76 10.54 11 70708 2049 90555679
Abortion spontaneous 11.68 10.54 15 70704 54041 90503687
Shock haemorrhagic 11.66 10.54 28 70691 12217 90545511
Depressed mood 11.61 10.54 73 70646 50149 90507579
Urinary incontinence 11.59 10.54 59 70660 37507 90520221
Appendicitis 11.52 10.54 25 70694 10206 90547522
Sleep disorder 11.47 10.54 99 70620 197931 90359797
Tongue exfoliation 11.45 10.54 4 70715 106 90557622
Life support 11.40 10.54 5 70714 246 90557482
Percutaneous coronary intervention 11.34 10.54 5 70714 249 90557479
Increased viscosity of upper respiratory secretion 11.24 10.54 5 70714 254 90557474
Walking aid user 11.08 10.54 7 70712 35499 90522229
Plethysmography 11.04 10.54 3 70716 33 90557695
Cardiac asthma 11.02 10.54 4 70715 119 90557609
Sleep disorder therapy 10.95 10.54 6 70713 480 90557248
Forced expiratory volume abnormal 10.89 10.54 4 70715 123 90557605
End stage renal disease 10.89 10.54 22 70697 8549 90549179
Paraesthesia 10.86 10.54 134 70585 250192 90307536
White blood cell count decreased 10.85 10.54 81 70638 167028 90390700
Chronic sinusitis 10.85 10.54 42 70677 23760 90533968
Pulmonary function test abnormal 10.84 10.54 12 70707 2727 90555001
Chronic respiratory failure 10.84 10.54 12 70707 2729 90554999
Sedation 10.79 10.54 13 70706 48158 90509570
Breath odour 10.79 10.54 9 70710 1442 90556286
Tricuspid valve incompetence 10.66 10.54 33 70686 16698 90541030
Quarantine 10.66 10.54 3 70716 38 90557690
Foreign body sensation in eyes 10.62 10.54 13 70706 3287 90554441
Rash erythematous 10.62 10.54 87 70632 65017 90492711
Product delivery mechanism issue 10.61 10.54 6 70713 510 90557218
False positive investigation result 10.60 10.54 7 70712 786 90556942
Electrocardiogram change 10.59 10.54 7 70712 787 90556941
Pancoast's syndrome 10.58 10.54 3 70716 39 90557689

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
Asthma 685.18 11.91 596 53929 61718 42505092
Chronic obstructive pulmonary disease 584.19 11.91 548 53977 62566 42504244
Wheezing 513.28 11.91 479 54046 54302 42512508
Obstructive airways disorder 411.34 11.91 302 54223 24457 42542353
Dyspnoea 333.29 11.91 1278 53247 441343 42125467
Appendicolith 320.38 11.91 205 54320 13251 42553559
Asthma-chronic obstructive pulmonary disease overlap syndrome 266.40 11.91 93 54432 1466 42565344
Appendicitis 258.66 11.91 213 54312 20400 42546410
Stress 220.08 11.91 277 54248 43935 42522875
Cardiogenic shock 206.22 11.91 241 54284 35399 42531411
Ventricular fibrillation 183.17 11.91 209 54316 29914 42536896
Full blood count abnormal 182.87 11.91 208 54317 29668 42537142
Sputum discoloured 173.64 11.91 126 54399 10006 42556804
Blood phosphorus increased 173.15 11.91 137 54388 12388 42554422
Cough 170.65 11.91 558 53967 177545 42389265
Hyperphosphataemia 151.98 11.91 129 54396 12875 42553935
Myasthenia gravis 148.77 11.91 140 54385 15997 42550813
Fractional exhaled nitric oxide increased 141.07 11.91 59 54466 1550 42565260
Analgesic therapy 137.21 11.91 92 54433 6432 42560378
Lower respiratory tract infection 124.98 11.91 204 54321 41002 42525808
Chest discomfort 122.51 11.91 259 54266 63357 42503453
Drug therapy 120.05 11.91 84 54441 6296 42560514
Sleep disorder therapy 114.20 11.91 84 54441 6810 42560000
Multiple organ dysfunction syndrome 113.27 11.91 326 54199 96709 42470101
Abdominal distension 112.35 11.91 269 54256 71466 42495344
Blood uric acid increased 112.08 11.91 118 54407 15429 42551381
Pulmonary function test decreased 111.44 11.91 77 54448 5655 42561155
Ascites 110.57 11.91 232 54293 56446 42510364
Nasal obstruction 109.39 11.91 43 54482 958 42565852
Sinus pain 108.93 11.91 42 54483 887 42565923
Toxicity to various agents 108.37 11.91 81 54444 229055 42337755
Myoglobin blood increased 105.12 11.91 63 54462 3619 42563191
Bronchiectasis 102.77 11.91 121 54404 17898 42548912
Hypophosphataemia 100.63 11.91 129 54396 20816 42545994
Plantar fasciitis 99.43 11.91 57 54468 3013 42563797
Incorrect route of product administration 97.37 11.91 137 54388 24168 42542642
Eosinophilia 97.22 11.91 161 54364 32738 42534072
Productive cough 95.86 11.91 207 54318 51360 42515450
Drug abuse 95.67 11.91 11 54514 104760 42462050
Sensation of foreign body 93.37 11.91 58 54467 3555 42563255
General physical health deterioration 92.56 11.91 411 54114 150835 42415975
Pneumonia 92.28 11.91 883 53642 421266 42145544
Iron deficiency 90.71 11.91 90 54435 10971 42555839
Bacterial infection 87.21 11.91 140 54385 27739 42539071
Neuralgia 86.05 11.91 133 54392 25514 42541296
Brain natriuretic peptide increased 84.97 11.91 70 54455 6700 42560110
Hyponatraemia 84.79 11.91 304 54221 101158 42465652
Completed suicide 83.55 11.91 12 54513 96453 42470357
Dry mouth 83.37 11.91 168 54357 39711 42527099
Dyspnoea exertional 81.68 11.91 191 54334 49957 42516853
Antacid therapy 81.58 11.91 59 54466 4658 42562152
Anticoagulant therapy 81.36 11.91 58 54467 4477 42562333
Blood cholesterol increased 77.85 11.91 130 54395 26611 42540199
Mycobacterium avium complex infection 74.21 11.91 47 54478 2980 42563830
Emphysema 73.41 11.91 83 54442 11752 42555058
Respiratory failure 71.53 11.91 339 54186 127793 42439017
Bronchitis 67.50 11.91 171 54354 47030 42519780
Breath sounds abnormal 66.96 11.91 80 54445 12013 42554797
Toxic epidermal necrolysis 66.11 11.91 121 54404 26629 42540181
Middle insomnia 64.72 11.91 64 54461 7769 42559041
Nasal congestion 63.71 11.91 126 54399 29375 42537435
Activated partial thromboplastin time prolonged 62.74 11.91 89 54436 15814 42550996
Secretion discharge 62.37 11.91 62 54463 7573 42559237
Bronchospasm 59.76 11.91 78 54447 12807 42554003
Bronchopulmonary aspergillosis allergic 58.66 11.91 48 54477 4550 42562260
Diarrhoea 58.64 11.91 348 54177 460501 42106309
Exostosis 56.04 11.91 51 54474 5580 42561230
Lung consolidation 55.99 11.91 55 54470 6622 42560188
Blood calcium increased 55.36 11.91 61 54464 8393 42558417
Oxygen saturation decreased 54.15 11.91 194 54331 64493 42502317
Respiratory distress 54.15 11.91 146 54379 41674 42525136
Hyperlipidaemia 52.75 11.91 97 54428 21419 42545391
Off label use 52.74 11.91 543 53982 637792 41929018
Respiratory disorder 52.19 11.91 98 54427 21987 42544823
Febrile neutropenia 52.09 11.91 99 54426 185604 42381206
Pulmonary function test abnormal 51.92 11.91 36 54489 2658 42564152
Total lung capacity decreased 51.38 11.91 40 54485 3530 42563280
Bronchospasm paradoxical 50.24 11.91 13 54512 66 42566744
Forced expiratory volume decreased 49.87 11.91 55 54470 7575 42559235
Swelling 49.75 11.91 169 54356 54716 42512094
Pneumothorax 48.97 11.91 99 54426 23444 42543366
Painful respiration 48.61 11.91 27 54498 1342 42565468
Osteopenia 47.66 11.91 49 54476 6229 42560581
Blood test abnormal 47.65 11.91 70 54455 12836 42553974
Aortic stenosis 47.02 11.91 57 54468 8688 42558122
Neutropenia 46.32 11.91 118 54407 199313 42367497
Sleep disorder 46.17 11.91 151 54374 47944 42518866
Bronchial hyperreactivity 44.93 11.91 29 54496 1900 42564910
Constipation 44.88 11.91 358 54167 161933 42404877
Lung opacity 43.31 11.91 45 54480 5792 42561018
Pulmonary mass 43.29 11.91 76 54449 16189 42550621
Foetal exposure during pregnancy 43.09 11.91 5 54520 47306 42519504
Troponin increased 43.08 11.91 83 54442 18979 42547831
Gout 42.58 11.91 104 54421 27951 42538859
Increased upper airway secretion 42.00 11.91 31 54494 2525 42564285
Malignant neoplasm progression 41.99 11.91 46 54479 108354 42458456
Throat irritation 41.49 11.91 66 54459 12970 42553840
Tachypnoea 41.43 11.91 88 54437 21574 42545236
Disease progression 40.78 11.91 76 54449 143580 42423230
Diabetes mellitus 40.30 11.91 168 54357 59919 42506891
End stage renal disease 39.77 11.91 74 54451 16484 42550326
Congenital hiatus hernia 39.48 11.91 44 54481 6130 42560680
Ulcer 38.90 11.91 73 54452 16368 42550442
Use of accessory respiratory muscles 38.58 11.91 17 54508 509 42566301
Dysphonia 38.52 11.91 101 54424 28349 42538461
Overdose 38.26 11.91 47 54478 105217 42461593
Eye disorder 37.25 11.91 59 54466 11553 42555257
Chest injury 36.65 11.91 25 54500 1797 42565013
Neuropathy peripheral 36.47 11.91 46 54479 101807 42465003
Pleural thickening 36.25 11.91 16 54509 481 42566329
Coronary artery disease 35.87 11.91 150 54375 53570 42513240
Treatment failure 35.27 11.91 18 54507 62606 42504204
Lung disorder 34.52 11.91 137 54388 47786 42519024
Thrombosis 34.42 11.91 176 54349 68335 42498475
White blood cell count decreased 33.49 11.91 56 54469 110340 42456470
Bacteroides infection 32.99 11.91 27 54498 2560 42564250
Rash 32.09 11.91 215 54310 276739 42290071
Drug hypersensitivity 31.81 11.91 227 54298 99162 42467648
Therapeutic product effect incomplete 31.39 11.91 176 54349 70763 42496047
Platelet count decreased 31.38 11.91 83 54442 138498 42428312
Genital herpes simplex 31.06 11.91 10 54515 121 42566689
Intentional overdose 30.18 11.91 14 54511 51442 42515368
Sepsis 29.18 11.91 386 54139 198948 42367862
Hyperkaliuria 29.06 11.91 9 54516 95 42566715
Rales 28.71 11.91 52 54473 11348 42555462
Pneumonitis 28.24 11.91 117 54408 41601 42525209
Drug resistance 27.97 11.91 5 54520 34243 42532567
Hypoventilation 27.65 11.91 29 54496 3773 42563037
Diaphragmatic disorder 27.32 11.91 18 54507 1221 42565589
Bronchitis viral 27.18 11.91 11 54514 265 42566545
Pleuritic pain 27.02 11.91 39 54486 7038 42559772
Drug ineffective 27.02 11.91 608 53917 629589 41937221
Sleep disorder due to a general medical condition 26.80 11.91 65 54460 17388 42549422
Walking aid user 26.50 11.91 24 54501 2609 42564201
Aspiration 25.76 11.91 65 54460 17821 42548989
Respiratory tract infection 25.57 11.91 83 54442 26239 42540571
Somnolence 25.31 11.91 284 54241 140821 42425989
Cardiac disorder 24.78 11.91 126 54399 48806 42518004
Cytokine release syndrome 24.77 11.91 13 54512 44514 42522296
Upper-airway cough syndrome 24.36 11.91 29 54496 4337 42562473
COVID-19 treatment 24.04 11.91 10 54515 259 42566551
Drug ineffective for unapproved indication 23.52 11.91 15 54510 46148 42520662
Bronchial wall thickening 23.49 11.91 17 54508 1343 42565467
Blood immunoglobulin E increased 23.46 11.91 26 54499 3599 42563211
Pulmonary embolism 23.42 11.91 245 54280 119367 42447443
Intentional product misuse 23.17 11.91 147 54378 61753 42505057
Pruritus 23.13 11.91 144 54381 188627 42378183
Foreign body in throat 22.62 11.91 12 54513 544 42566266
Type IIa hyperlipidaemia 22.43 11.91 10 54515 308 42566502
Myelosuppression 22.24 11.91 12 54513 40449 42526361
Suicide attempt 22.12 11.91 16 54509 46084 42520726
Forced vital capacity decreased 21.57 11.91 14 54511 926 42565884
Lung hyperinflation 21.53 11.91 15 54510 1116 42565694
Pancreatitis acute 21.51 11.91 8 54517 33556 42533254
Injection related reaction 21.47 11.91 12 54513 604 42566206
Sensitivity to weather change 21.31 11.91 19 54506 2024 42564786
Micturition urgency 21.22 11.91 47 54478 11851 42554959
Hypercapnia 21.14 11.91 30 54495 5331 42561479
Wolff-Parkinson-White syndrome 21.08 11.91 9 54516 249 42566561
Upper respiratory tract infection 20.94 11.91 108 54417 42065 42524745
Ischaemic cardiomyopathy 20.73 11.91 33 54492 6489 42560321
Oral candidiasis 20.38 11.91 52 54473 14353 42552457
Benign prostatic hyperplasia 20.11 11.91 66 54459 20986 42545824
Respiratory acidosis 20.07 11.91 32 54493 6299 42560511
Chronic respiratory failure 19.94 11.91 17 54508 1705 42565105
Blood immunoglobulin E decreased 19.94 11.91 6 54519 57 42566753
Arthritis 19.67 11.91 15 54510 42050 42524760
Drug interaction 19.55 11.91 233 54292 266766 42300044
Acute kidney injury 19.40 11.91 342 54183 366995 42199815
Seasonal allergy 19.34 11.91 36 54489 8019 42558791
Suicidal ideation 19.13 11.91 20 54505 48141 42518669
Aggression 19.10 11.91 17 54508 44146 42522664
Leukopenia 19.09 11.91 42 54483 74704 42492106
Atrial fibrillation 19.04 11.91 267 54258 139326 42427484
Peak expiratory flow rate decreased 19.04 11.91 7 54518 129 42566681
Colitis ulcerative 18.98 11.91 5 54520 26170 42540640
Cytomegalovirus infection 18.62 11.91 9 54516 32297 42534513
Hypohidrosis 18.62 11.91 8 54517 225 42566585
Oedema peripheral 17.65 11.91 258 54267 135818 42430992
Premature baby 17.62 11.91 4 54521 23149 42543661
Infective pulmonary exacerbation of cystic fibrosis 17.61 11.91 34 54491 7784 42559026
Tachycardia foetal 17.53 11.91 9 54516 381 42566429
Condition aggravated 17.53 11.91 447 54078 260307 42306503
Myalgia 17.18 11.91 64 54461 96016 42470794
Illness 16.93 11.91 70 54455 24860 42541950
Bilirubin conjugated abnormal 16.77 11.91 6 54519 102 42566708
Aortic aneurysm 16.68 11.91 33 54492 7690 42559120
Respiratory symptom 16.67 11.91 41 54484 11065 42555745
Genital herpes 16.63 11.91 11 54514 751 42566059
Infusion related reaction 16.51 11.91 33 54492 60773 42506037
Reversible airways obstruction 16.39 11.91 10 54515 593 42566217
Psoriasis 16.32 11.91 23 54502 48581 42518229
Interstitial lung disease 16.26 11.91 49 54476 78413 42488397
Drug-induced liver injury 16.23 11.91 15 54510 38258 42528552
Mucosal inflammation 15.95 11.91 24 54501 49350 42517460
Stomatitis 15.75 11.91 25 54500 50304 42516506
Fatigue 15.43 11.91 432 54093 435209 42131601
Renal impairment 15.14 11.91 81 54444 110147 42456663
Dysgeusia 14.97 11.91 13 54512 34176 42532634
Joint injury 14.91 11.91 47 54478 14629 42552181
Viral myelitis 14.80 11.91 5 54520 71 42566739
Product use issue 14.47 11.91 50 54475 76701 42490109
Drug intolerance 14.46 11.91 162 54363 80262 42486548
Respiratory tract congestion 14.46 11.91 31 54494 7647 42559163
Abdominal pain 14.44 11.91 332 54193 190139 42376671
C-reactive protein increased 14.42 11.91 38 54487 63522 42503288
COVID-19 14.42 11.91 88 54437 115860 42450950
Neutrophil count decreased 14.32 11.91 38 54487 63377 42503433
Perfume sensitivity 14.26 11.91 6 54519 160 42566650
Therapy partial responder 14.19 11.91 4 54521 20017 42546793
Occupational exposure to air contaminants 14.06 11.91 6 54519 166 42566644
Neoplasm progression 14.00 11.91 10 54515 28990 42537820
Cardiovascular disorder 13.76 11.91 43 54482 13322 42553488
Hypoxia 13.67 11.91 143 54382 69643 42497167
Carbon dioxide increased 13.60 11.91 12 54513 1260 42565550
Toxic optic neuropathy 13.57 11.91 11 54514 1029 42565781
Sneezing 13.52 11.91 27 54498 6336 42560474
Tooth erosion 13.46 11.91 5 54520 95 42566715
Multiple allergies 13.44 11.91 20 54505 3708 42563102
Ocular discomfort 13.39 11.91 18 54507 3039 42563771
Disease recurrence 13.35 11.91 11 54514 29667 42537143
Therapeutic product effect prolonged 13.32 11.91 7 54518 311 42566499
Status asthmaticus 13.16 11.91 7 54518 319 42566491
Hepatic function abnormal 13.15 11.91 29 54496 51538 42515272
Pneumocystis jirovecii pneumonia 13.08 11.91 8 54517 25173 42541637
Memory impairment 13.01 11.91 28 54497 50194 42516616
Lung diffusion test decreased 12.98 11.91 10 54515 869 42565941
Sedation 12.85 11.91 12 54513 30463 42536347
Feeling cold 12.68 11.91 41 54484 12932 42553878
Vital capacity decreased 12.61 11.91 8 54517 509 42566301
Left ventricular hypertrophy 12.53 11.91 33 54492 9286 42557524
Vasculitis 12.45 11.91 4 54521 18390 42548420
Skin lesion 12.31 11.91 10 54515 27164 42539646
Frequent bowel movements 12.28 11.91 6 54519 21401 42545409
Headache 12.25 11.91 224 54301 239145 42327665
Pancreatitis 12.16 11.91 23 54502 43245 42523565
Drug reaction with eosinophilia and systemic symptoms 12.15 11.91 22 54503 42053 42524757
Arthralgia 12.15 11.91 187 54338 205051 42361759
Mycobacterial infection 12.13 11.91 16 54509 2652 42564158
Lymphadenopathy 12.00 11.91 15 54510 33350 42533460
Influenza 11.99 11.91 127 54398 62048 42504762
Therapeutic response decreased 11.95 11.91 18 54507 36994 42529816

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 1559.04 10.99 1549 106817 248742 110232191
Chronic obstructive pulmonary disease 1270.23 10.99 966 107400 108192 110372741
Obstructive airways disorder 1081.60 10.99 632 107734 45517 110435416
Wheezing 890.77 10.99 1171 107195 254059 110226874
Dyspnoea 712.46 10.99 2536 105830 1104336 109376597
Asthma-chronic obstructive pulmonary disease overlap syndrome 518.04 10.99 205 108161 6139 110474794
Cough 475.84 10.99 1250 107116 460391 110020542
Bronchiectasis 426.22 10.99 324 108042 36169 110444764
Full blood count abnormal 414.29 10.99 382 107984 55670 110425263
Appendicolith 400.67 10.99 220 108146 14035 110466898
Productive cough 394.20 10.99 522 107844 113783 110367150
Pneumonia 357.19 10.99 1749 106617 874965 109605968
Sputum discoloured 352.83 10.99 260 108106 27685 110453248
Appendicitis 291.80 10.99 234 108132 28230 110452703
Chest discomfort 283.48 10.99 565 107801 173283 110307650
Total lung capacity increased 266.22 10.99 120 108246 4992 110475941
Blood test abnormal 241.41 10.99 210 108156 28344 110452589
Synovitis 236.37 10.99 7 108359 274085 110206848
Bronchopulmonary aspergillosis allergic 217.56 10.99 123 108243 8303 110472630
Nasal polyps 216.04 10.99 144 108222 13056 110467877
Middle insomnia 211.11 10.99 169 108197 20333 110460600
Nasal congestion 208.68 10.99 358 108008 97924 110383009
Blood phosphorus increased 208.44 10.99 153 108213 16187 110464746
Stress 207.16 10.99 371 107995 104977 110375956
Rales 203.23 10.99 179 108187 24560 110456373
Systemic lupus erythematosus 201.08 10.99 12 108354 254326 110226607
Total lung capacity decreased 200.48 10.99 110 108256 7004 110473929
Dyspnoea exertional 200.20 10.99 363 108003 103697 110377236
Cardiogenic shock 197.78 10.99 262 108104 57076 110423857
Hyperphosphataemia 196.90 10.99 148 108218 16233 110464700
Hand deformity 194.40 10.99 4 108362 218502 110262431
Ventricular fibrillation 193.04 10.99 220 108146 41093 110439840
Completed suicide 192.95 10.99 11 108355 242370 110238563
Analgesic therapy 192.60 10.99 108 108258 7176 110473757
Cardiac murmur 192.00 10.99 173 108193 24455 110456478
Rhinitis allergic 189.38 10.99 150 108216 17772 110463161
Breath sounds abnormal 185.45 10.99 172 108194 25232 110455701
Glossodynia 183.32 10.99 8 108358 221996 110258937
Blood calcium increased 180.01 10.99 146 108220 17894 110463039
Pericarditis 177.36 10.99 9 108357 219105 110261828
Infusion related reaction 175.31 10.99 77 108289 381085 110099848
Pemphigus 173.08 10.99 9 108357 214561 110266372
Respiratory failure 171.46 10.99 532 107834 214800 110266133
Drug therapy 171.07 10.99 100 108266 7191 110473742
Arthropathy 169.91 10.99 37 108329 287485 110193448
Myasthenia gravis 169.45 10.99 152 108214 21359 110459574
Alopecia 167.25 10.99 74 108292 364679 110116254
Lung opacity 166.73 10.99 117 108249 11535 110469398
Sarcoidosis 165.47 10.99 120 108246 12459 110468474
Toxicity to various agents 162.80 10.99 139 108227 480416 110000517
Treatment failure 161.15 10.99 37 108329 277197 110203736
Sleep disorder due to a general medical condition 159.88 10.99 225 108141 51887 110429046
Eosinophilia 155.75 10.99 235 108131 57701 110423232
Toxic epidermal necrolysis 155.21 10.99 232 108134 56495 110424438
Duodenal ulcer perforation 151.51 10.99 5 108361 177695 110303238
Sleep disorder therapy 145.69 10.99 91 108275 7380 110473553
Helicobacter infection 145.53 10.99 8 108358 181869 110299064
Joint swelling 137.10 10.99 139 108227 442706 110038227
Blood uric acid increased 136.74 10.99 135 108231 21394 110459539
Contraindicated product administered 127.69 10.99 42 108324 248225 110232708
Wound 127.18 10.99 36 108330 234401 110246532
Aspiration 126.68 10.99 153 108213 30380 110450553
Antacid therapy 125.46 10.99 74 108292 5410 110475523
Multiple organ dysfunction syndrome 124.60 10.99 379 107987 151331 110329602
Anticoagulant therapy 124.38 10.99 73 108293 5288 110475645
Bronchitis 124.05 10.99 387 107979 156645 110324288
Forced expiratory volume decreased 123.84 10.99 103 108263 13073 110467860
Oxygen saturation decreased 121.36 10.99 384 107982 156598 110324335
Bronchospasm 121.35 10.99 149 108217 30090 110450843
Maternal exposure during pregnancy 121.14 10.99 49 108317 254834 110226099
Haemoptysis 121.14 10.99 236 108130 71118 110409815
Muscle injury 119.90 10.99 4 108362 140803 110340130
Psoriatic arthropathy 118.93 10.99 24 108342 196737 110284196
Lung neoplasm malignant 118.79 10.99 156 108210 33686 110447247
Bacterial infection 117.07 10.99 182 108184 45854 110435079
Pulmonary function test decreased 116.73 10.99 84 108282 8616 110472317
Drug abuse 115.14 10.99 18 108348 177393 110303540
Upper-airway cough syndrome 115.04 10.99 107 108259 15750 110465183
Gastrooesophageal reflux disease 112.50 10.99 410 107956 179566 110301367
Oedema peripheral 111.88 10.99 625 107741 328035 110152898
Impaired healing 110.87 10.99 28 108338 196689 110284244
Ascites 110.57 10.99 266 108100 92542 110388391
Rheumatoid arthritis 109.79 10.99 80 108286 299533 110181400
Nasal obstruction 109.00 10.99 57 108309 3293 110477640
Hypoxia 108.65 10.99 326 108040 129189 110351744
Hypomania 106.90 10.99 85 108281 10125 110470808
Irritable bowel syndrome 105.80 10.99 17 108349 164198 110316735
Respiratory distress 105.20 10.99 218 108148 68656 110412277
Blister 104.38 10.99 46 108320 227330 110253603
Abdominal discomfort 103.24 10.99 141 108225 393717 110087216
Therapeutic product effect decreased 102.20 10.99 56 108310 244260 110236673
Off label use 100.90 10.99 963 107403 1499222 108981711
Upper respiratory tract infection 100.36 10.99 320 108046 131008 110349925
Blood immunoglobulin E increased 99.83 10.99 72 108294 7410 110473523
Rash 99.58 10.99 440 107926 820524 109660409
Hypophosphataemia 98.43 10.99 141 108225 33041 110447892
Lower respiratory tract infection 97.60 10.99 484 107882 242622 110238311
Jaundice cholestatic 97.26 10.99 94 108272 14514 110466419
Bronchial neoplasm 95.95 10.99 31 108335 505 110480428
Hyperlipidaemia 94.34 10.99 144 108222 35704 110445229
Iron deficiency 94.21 10.99 103 108263 18373 110462560
Arthralgia 93.24 10.99 420 107946 779212 109701721
Nasal turbinate hypertrophy 93.19 10.99 34 108332 810 110480123
C-reactive protein abnormal 91.73 10.99 10 108356 129685 110351248
Restrictive pulmonary disease 90.75 10.99 50 108316 3209 110477724
Sleep apnoea syndrome 90.67 10.99 151 108215 40296 110440637
Activated partial thromboplastin time prolonged 89.40 10.99 110 108256 22258 110458675
Pulmonary mass 88.67 10.99 143 108223 37158 110443775
Tachypnoea 88.21 10.99 147 108219 39248 110441685
Emphysema 86.90 10.99 102 108264 19654 110461279
Sleep disorder due to general medical condition, insomnia type 86.55 10.99 4 108362 105639 110375294
Hyponatraemia 85.71 10.99 431 107935 217222 110263711
Bursitis 84.71 10.99 13 108353 129905 110351028
Respiration abnormal 84.64 10.99 73 108293 9736 110471197
Aortic stenosis 83.14 10.99 82 108284 12977 110467956
Pleuritic pain 82.34 10.99 90 108276 16050 110464883
Rhonchi 80.54 10.99 52 108314 4466 110476467
Intentional product use issue 78.74 10.99 76 108290 247830 110233103
Endometrial ablation 78.67 10.99 31 108335 917 110480016
Gout 77.31 10.99 133 108233 36433 110444500
Hypercapnia 76.55 10.99 73 108293 11086 110469847
Acute respiratory failure 76.38 10.99 203 108163 75057 110405876
Product use issue 75.37 10.99 118 108248 311577 110169356
Neuralgia 74.68 10.99 154 108212 48324 110432609
Stomatitis 73.59 10.99 94 108272 270148 110210785
Hyper IgE syndrome 73.58 10.99 27 108339 654 110480279
Heart sounds 73.06 10.99 31 108335 1112 110479821
Oesophageal spasm 72.35 10.99 45 108321 3621 110477312
Vocal cord dysfunction 71.66 10.99 29 108337 921 110480012
Ventricular failure 71.33 10.99 25 108341 528 110480405
Bronchospasm paradoxical 70.73 10.99 20 108346 201 110480732
Mobility decreased 70.62 10.99 77 108289 237345 110243588
Bronchial haemorrhage 70.45 10.99 32 108334 1355 110479578
Inflammation 70.24 10.99 52 108314 193186 110287747
Prolonged expiration 70.08 10.99 33 108333 1519 110479414
Joint range of motion decreased 69.30 10.99 17 108349 121815 110359118
Liver injury 68.12 10.99 31 108335 150382 110330551
Drug-induced liver injury 67.81 10.99 17 108349 120050 110360883
Fractional exhaled nitric oxide increased 66.60 10.99 26 108340 750 110480183
Diarrhoea 66.36 10.99 756 107610 1138749 109342184
Exposure during pregnancy 66.28 10.99 41 108325 167383 110313550
End stage renal disease 66.27 10.99 93 108273 21380 110459553
Abdominal distension 65.61 10.99 342 108024 174761 110306172
Coronary artery disease 65.42 10.99 186 108180 71504 110409429
Lip dry 65.28 10.99 10 108356 100073 110380860
Hypoaesthesia 64.25 10.99 132 108234 314091 110166842
Pulmonary embolism 62.68 10.99 392 107974 214082 110266851
Schizophrenia 62.18 10.99 91 108275 21735 110459198
Constipation 61.80 10.99 578 107788 357208 110123725
C-reactive protein increased 61.21 10.99 74 108292 217845 110263088
Therapeutic product effect incomplete 61.07 10.99 402 107964 223403 110257530
Diabetes mellitus 60.88 10.99 225 108141 99156 110381777
Myelosuppression 60.24 10.99 10 108356 94330 110386603
Pain 60.18 10.99 622 107744 954333 109526600
Drug intolerance 60.04 10.99 201 108165 406311 110074622
Grip strength decreased 59.82 10.99 5 108361 80169 110400764
Rhinitis 58.53 10.99 90 108276 22455 110458478
Red blood cell sedimentation rate increased 58.10 10.99 5 108361 78297 110402636
Respiratory rate increased 58.04 10.99 95 108271 24988 110455945
Pulmonary function test abnormal 57.49 10.99 44 108322 4956 110475977
Bronchial disorder 57.14 10.99 35 108331 2741 110478192
Bronchial hyperreactivity 56.40 10.99 38 108328 3506 110477427
Lung hyperinflation 56.09 10.99 32 108334 2197 110478736
Discomfort 56.08 10.99 77 108289 214630 110266303
Hepatic enzyme increased 55.04 10.99 148 108218 320744 110160189
Dysphonia 54.37 10.99 181 108185 75748 110405185
Drug ineffective 53.57 10.99 1111 107255 1519429 108961504
Intentional overdose 53.06 10.99 32 108334 132469 110348464
Loss of personal independence in daily activities 52.78 10.99 288 108078 149732 110331201
Breast conserving surgery 52.72 10.99 23 108343 884 110480049
Rib deformity 52.29 10.99 16 108350 216 110480717
Oesophageal pain 52.23 10.99 42 108324 5083 110475850
Laryngeal stenosis 51.90 10.99 26 108340 1372 110479561
Respiratory disorder 50.96 10.99 170 108196 71212 110409721
Congenital hiatus hernia 50.82 10.99 45 108321 6214 110474719
Transaminases increased 50.74 10.99 157 108209 63233 110417700
Influenza 49.35 10.99 309 108057 168792 110312141
Mycobacterium avium complex infection 49.22 10.99 43 108323 5834 110475099
Gastrointestinal disorder 49.14 10.99 102 108264 241850 110239083
Night sweats 48.75 10.99 36 108330 133947 110346986
Sepsis 48.35 10.99 512 107854 326834 110154099
Tremor 47.93 10.99 351 108015 201881 110279052
Incorrect route of product administration 47.92 10.99 155 108211 63906 110417027
Troponin increased 47.55 10.99 96 108270 29670 110451263
Atrial fibrillation 47.44 10.99 386 107980 229256 110251677
Increased upper airway secretion 45.27 10.99 39 108327 5193 110475740
Nail disorder 44.96 10.99 3 108363 57932 110423001
Hypoventilation 44.63 10.99 47 108319 8034 110472899
Frequent bowel movements 44.63 10.99 8 108358 71382 110409551
Respiratory tract infection 44.58 10.99 163 108203 71454 110409479
Epidermal necrosis 44.51 10.99 31 108335 3019 110477914
Pneumonitis 44.16 10.99 170 108196 76361 110404572
Autoimmune disorder 43.96 10.99 6 108360 65477 110415456
Heart rate increased 43.96 10.99 266 108100 143568 110337365
Adverse event 43.96 10.99 26 108340 108783 110372150
Status asthmaticus 43.93 10.99 21 108345 1000 110479933
Peripheral swelling 43.90 10.99 225 108141 403809 110077124
Lower limb fracture 43.86 10.99 10 108356 75338 110405595
Musculoskeletal pain 43.54 10.99 70 108296 182953 110297980
Impaired quality of life 43.49 10.99 93 108273 29924 110451009
Thrombosis 43.32 10.99 216 108150 108446 110372487
Pleural effusion 43.01 10.99 310 108056 177399 110303534
Febrile neutropenia 42.51 10.99 163 108203 316604 110164329
Sciatica 41.90 10.99 19 108347 92380 110388553
Respiratory acidosis 41.36 10.99 59 108307 13767 110467166
Infective pulmonary exacerbation of cystic fibrosis 41.23 10.99 61 108305 14710 110466223
Throat clearing 40.98 10.99 34 108332 4299 110476634
PCO2 increased 40.88 10.99 25 108341 1952 110478981
Cardiac failure congestive 40.43 10.99 270 108096 150730 110330203
Reversible airways obstruction 40.26 10.99 27 108339 2472 110478461
Hip arthroplasty 40.24 10.99 4 108362 55809 110425124
Drug ineffective for unapproved indication 39.57 10.99 26 108340 102812 110378121
Taste disorder 39.44 10.99 8 108358 65379 110415554
Fibromyalgia 39.14 10.99 67 108299 170842 110310091
PO2 decreased 39.07 10.99 29 108337 3119 110477814
Neuropathy peripheral 38.62 10.99 73 108293 179204 110301729
Disease progression 38.56 10.99 117 108249 243917 110237016
Pneumonia viral 38.48 10.99 51 108315 11106 110469827
COVID-19 treatment 37.93 10.99 15 108351 448 110480485
Lung consolidation 37.86 10.99 49 108317 10427 110470506
Epilepsy 37.67 10.99 26 108340 100183 110380750
Wound infection 37.65 10.99 24 108342 96441 110384492
Sinus pain 37.58 10.99 37 108329 5842 110475091
Decreased appetite 37.29 10.99 293 108073 475553 110005380
Peripheral venous disease 37.06 10.99 18 108348 84099 110396834
Overdose 37.01 10.99 112 108254 233682 110247251
Painful respiration 36.69 10.99 30 108336 3717 110477216
Bacteroides infection 36.48 10.99 27 108339 2892 110478041
Ill-defined disorder 36.37 10.99 61 108305 156792 110324141
Hypersensitivity 35.88 10.99 240 108126 403758 110077175
Myoglobin blood increased 35.51 10.99 31 108335 4201 110476732
Paraesthesia 35.38 10.99 145 108221 276376 110204557
Prescribed overdose 35.28 10.99 21 108345 87560 110393373
Pneumothorax 34.61 10.99 94 108272 35191 110445742
Thermohypoaesthesia 34.39 10.99 10 108356 112 110480821
Benign prostatic hyperplasia 34.27 10.99 63 108303 18171 110462762
Liver disorder 34.21 10.99 54 108312 142189 110338744
Eosinophil count abnormal 34.16 10.99 18 108348 1056 110479877
Neutropenia 34.04 10.99 221 108145 374399 110106534
Sinus tachycardia 33.59 10.99 108 108258 44385 110436548
White blood cell count decreased 32.76 10.99 115 108251 229275 110251658
Blood creatinine increased 32.31 10.99 297 108069 182592 110298341
Sight disability 32.28 10.99 11 108355 213 110480720
Underdose 32.22 10.99 11 108355 63543 110417390
Influenza B virus test positive 32.18 10.99 13 108353 411 110480522
Peak expiratory flow rate decreased 31.96 10.99 15 108351 685 110480248
Diaphragmatic disorder 31.89 10.99 21 108345 1865 110479068
Drug resistance 31.79 10.99 8 108358 56366 110424567
Psychotic disorder 31.76 10.99 116 108250 50821 110430112
Gait inability 31.65 10.99 53 108313 136323 110344610
Use of accessory respiratory muscles 31.64 10.99 15 108351 701 110480232
Respiratory gas exchange disorder 31.29 10.99 16 108350 882 110480051
Respiratory symptom 31.12 10.99 54 108312 14891 110466042
Psoriasis 31.04 10.99 56 108310 139937 110340996
Blood bilirubin increased 30.97 10.99 152 108214 75820 110405113
Cyanosis 30.96 10.99 81 108285 29660 110451273
Brain natriuretic peptide increased 30.87 10.99 46 108320 11163 110469770
Aortic aneurysm 30.72 10.99 43 108323 9861 110471072
Chest injury 30.69 10.99 26 108340 3383 110477550
Cardiac disorder 30.66 10.99 152 108214 76128 110404805
Colitis ulcerative 30.53 10.99 19 108347 77344 110403589
Arthritis 30.48 10.99 75 108291 167511 110313422
Polycystic ovaries 30.31 10.99 30 108336 4766 110476167
Venous pressure jugular increased 30.29 10.99 18 108348 1334 110479599
Kyphosis 30.13 10.99 25 108341 3162 110477771
Knee arthroplasty 30.01 10.99 13 108353 64935 110415998
Sinus disorder 29.94 10.99 85 108281 32643 110448290
Lymphoedema 29.86 10.99 53 108313 14876 110466057
Seasonal allergy 29.61 10.99 62 108304 19660 110461273
Cholelithiasis 29.61 10.99 132 108234 63290 110417643
Chronic respiratory failure 29.60 10.99 27 108339 3876 110477057
Road traffic accident 29.58 10.99 37 108329 107361 110373572
Coeliac disease 28.89 10.99 4 108362 43183 110437750
Plantar fasciitis 28.76 10.99 30 108336 5071 110475862
Frustration tolerance decreased 28.72 10.99 39 108327 8692 110472241
Secretion discharge 28.50 10.99 62 108304 20182 110460751
Ischaemic cardiomyopathy 28.22 10.99 37 108329 7974 110472959
Malignant neoplasm progression 28.07 10.99 83 108283 174484 110306449
Somnolence 27.99 10.99 428 107938 297021 110183912
Myocardial infarction 26.29 10.99 296 108070 191787 110289146
Granuloma 26.22 10.99 39 108327 9451 110471482
Injury 25.90 10.99 88 108278 177177 110303756
Pulmonary hypertension 25.83 10.99 115 108251 55105 110425828
Hyperkaliuria 25.82 10.99 9 108357 187 110480746
Prescribed underdose 25.73 10.99 16 108350 65158 110415775
Rash papular 25.49 10.99 72 108294 27567 110453366
Memory impairment 25.35 10.99 103 108263 196841 110284092
Pruritus 25.33 10.99 409 107957 581151 109899782
Platelet count decreased 25.19 10.99 128 108238 230315 110250618
Cytomegalovirus infection 24.99 10.99 11 108355 54433 110426500
Lactic acidosis 24.86 10.99 166 108200 92645 110388288
Lactose intolerance 24.64 10.99 21 108345 2755 110478178
Lupus-like syndrome 24.58 10.99 5 108361 40787 110440146
Therapy non-responder 24.43 10.99 76 108290 157231 110323702
Separation anxiety disorder 24.38 10.99 6 108360 33 110480900
Airway peak pressure increased 23.96 10.99 12 108354 633 110480300
Affective disorder 23.91 10.99 41 108325 11200 110469733
Obesity 23.67 10.99 47 108319 113304 110367629
Eosinophil count increased 23.63 10.99 59 108307 20999 110459934
Hepatic cirrhosis 23.54 10.99 19 108347 67607 110413326
Foot deformity 23.54 10.99 9 108357 48471 110432462
Type IIa hyperlipidaemia 23.47 10.99 11 108355 501 110480432
Rhinorrhoea 23.07 10.99 176 108190 102490 110378443
Supraventricular tachycardia 22.90 10.99 64 108302 24358 110456575
General physical health deterioration 22.90 10.99 562 107804 424733 110056200
Asthmatic crisis 22.78 10.99 18 108348 2124 110478809
Osteopenia 22.62 10.99 60 108306 22149 110458784
Sedation 22.53 10.99 21 108345 69662 110411271
Muscle spasticity 22.50 10.99 4 108362 35911 110445022
Wolff-Parkinson-White syndrome 22.41 10.99 10 108356 406 110480527
Suicide attempt 22.35 10.99 42 108324 103352 110377581
Suicidal ideation 22.27 10.99 36 108330 93901 110387032
Lung neoplasm 22.04 10.99 33 108333 8043 110472890
Blood pH decreased 22.03 10.99 25 108341 4644 110476289
FEV1/FVC ratio decreased 22.03 10.99 9 108357 293 110480640
Cytokine release syndrome 21.79 10.99 22 108344 70284 110410649
Multiple sclerosis relapse 21.75 10.99 11 108355 50229 110430704
Appetite disorder 21.26 10.99 36 108330 9733 110471200
Ulcer 21.08 10.99 91 108275 43025 110437908
Respiratory alkalosis 21.05 10.99 27 108339 5694 110475239
Obstruction 20.94 10.99 27 108339 5725 110475208
Joint stiffness 20.89 10.99 21 108345 67222 110413711
Heparin-induced thrombocytopenia 20.88 10.99 39 108327 11385 110469548
Dyslipidaemia 20.35 10.99 47 108319 15918 110465015
Injection site reaction 20.31 10.99 35 108331 89035 110391898
Sputum purulent 20.29 10.99 16 108350 1882 110479051
Nasal discharge discolouration 20.19 10.99 20 108346 3181 110477752
Premature delivery 20.11 10.99 3 108363 30629 110450304
Genital herpes simplex 20.06 10.99 10 108356 522 110480411
Product dose omission issue 20.03 10.99 434 107932 321348 110159585
Rectal prolapse 19.96 10.99 18 108348 2545 110478388
Injection site bruising 19.67 10.99 13 108353 51250 110429683
Cor pulmonale 19.64 10.99 17 108349 2277 110478656
Depressive symptom 19.64 10.99 32 108334 8382 110472551
Hepatic function abnormal 19.54 10.99 36 108330 89259 110391674
Basal cell carcinoma 19.47 10.99 10 108356 45260 110435673
Pneumonia pseudomonal 19.41 10.99 30 108336 7516 110473417
Sneezing 19.23 10.99 72 108294 31912 110449021
Hepatitis 19.10 10.99 37 108329 90017 110390916
Eye pruritus 19.06 10.99 73 108293 32702 110448231
Leukopenia 19.03 10.99 78 108288 148713 110332220
Poisoning 18.77 10.99 3 108363 29102 110451831
Bundle branch block left 18.75 10.99 40 108326 12848 110468085
Pneumococcal infection 18.73 10.99 15 108351 1804 110479129
Foreign body in throat 18.37 10.99 12 108354 1051 110479882
Oropharyngeal pain 18.29 10.99 208 108158 135068 110345865
Fatigue 18.28 10.99 990 107376 1214968 109265965
Generalised tonic-clonic seizure 18.25 10.99 16 108350 54664 110426269
Hypohidrosis 18.09 10.99 8 108358 318 110480615
Sensitivity to weather change 18.03 10.99 34 108332 9994 110470939
Peak expiratory flow rate abnormal 17.91 10.99 6 108360 110 110480823
Palmar-plantar erythrodysaesthesia syndrome 17.74 10.99 9 108357 41016 110439917
Forced vital capacity decreased 17.69 10.99 15 108351 1955 110478978
Humidity intolerance 17.69 10.99 9 108357 491 110480442
Drug eruption 17.55 10.99 16 108350 53643 110427290
Micturition urgency 17.50 10.99 50 108316 19270 110461663
Swelling 17.29 10.99 241 108125 350800 110130133
Colitis ischaemic 17.12 10.99 47 108319 17703 110463230
Viral myelitis 16.98 10.99 6 108360 130 110480803
Throat irritation 16.97 10.99 100 108266 53452 110427481
Angle closure glaucoma 16.96 10.99 19 108347 3480 110477453
Pneumonia staphylococcal 16.78 10.99 25 108341 6066 110474867
Anaemia 16.71 10.99 675 107691 546411 109934522
Multimorbidity 16.66 10.99 13 108353 1507 110479426
Infective exacerbation of chronic obstructive airways disease 16.64 10.99 18 108348 3172 110477761
Bronchial wall thickening 16.56 10.99 18 108348 3189 110477744
Upper respiratory tract irritation 16.55 10.99 7 108359 249 110480684
Tachycardia 16.53 10.99 313 108053 226332 110254601
Long QT syndrome 16.52 10.99 27 108339 7091 110473842
Haematoma 16.52 10.99 106 108260 58370 110422563
Cardiovascular disorder 16.06 10.99 54 108312 22706 110458227
Subcutaneous emphysema 16.03 10.99 16 108350 2568 110478365
Toxic optic neuropathy 15.96 10.99 12 108354 1316 110479617
Terminal insomnia 15.87 10.99 14 108352 1924 110479009
Neutrophil count decreased 15.72 10.99 63 108303 120878 110360055
Eye disorder 15.69 10.99 63 108303 28843 110452090
Cytopenia 15.64 10.99 5 108361 30111 110450822
Occupational exposure to air contaminants 15.60 10.99 6 108360 166 110480767
Sensation of foreign body 15.55 10.99 28 108338 7947 110472986
Chest X-ray abnormal 15.54 10.99 29 108337 8458 110472475
Hyperglycaemia 15.43 10.99 139 108227 84951 110395982
Tracheomalacia 15.42 10.99 9 108357 645 110480288
Headache 15.25 10.99 708 107658 881669 109599264
Mucosal inflammation 15.24 10.99 46 108320 96095 110384838
Dystrophic calcification 15.24 10.99 6 108360 177 110480756
Tracheitis 15.24 10.99 13 108353 1708 110479225
Osteoarthritis 14.96 10.99 111 108255 182512 110298421
Pupillary reflex impaired 14.86 10.99 19 108347 3996 110476937
Loss of consciousness 14.83 10.99 122 108244 196184 110284749
Illness 14.79 10.99 134 108232 82037 110398896
Therapy partial responder 14.76 10.99 9 108357 37052 110443881
Carbon dioxide increased 14.75 10.99 16 108350 2828 110478105
Bilirubin conjugated abnormal 14.73 10.99 6 108360 194 110480739
Extrapyramidal disorder 14.62 10.99 5 108361 28862 110452071
Eating disorder 14.54 10.99 6 108360 30852 110450081
Contusion 14.21 10.99 153 108213 233208 110247725
Injection related reaction 14.14 10.99 12 108354 1566 110479367
Brain hypoxia 14.12 10.99 11 108355 1271 110479662
Ataxia 13.95 10.99 6 108360 30102 110450831
Muscular weakness 13.92 10.99 166 108200 248302 110232631
Hepatotoxicity 13.86 10.99 108 108258 63292 110417641
Dysgeusia 13.78 10.99 30 108336 69955 110410978
Myelodysplastic syndrome 13.72 10.99 10 108356 37474 110443459
Vascular parkinsonism 13.71 10.99 5 108361 119 110480814
Neck pain 13.68 10.99 68 108298 123062 110357871
Restless legs syndrome 13.63 10.99 54 108312 24572 110456361
Lung diffusion test decreased 13.58 10.99 12 108354 1653 110479280
Nephropathy toxic 13.51 10.99 5 108361 27473 110453460
Bronchitis viral 13.47 10.99 11 108355 1360 110479573
Feeling hot 13.46 10.99 45 108321 91061 110389872
Pneumonia respiratory syncytial viral 13.45 10.99 15 108351 2734 110478199
Visual impairment 13.40 10.99 77 108289 134351 110346582
Gait disturbance 13.34 10.99 192 108174 278016 110202917
Pulmonary oedema 13.26 10.99 154 108212 100505 110380428
Thrombotic microangiopathy 13.20 10.99 6 108360 29143 110451790
Onychomycosis 13.19 10.99 11 108355 38520 110442413
Forced expiratory volume increased 13.19 10.99 5 108361 133 110480800
Sopor 13.06 10.99 10 108356 36536 110444397
Thrombocytopenia 13.05 10.99 252 108114 348633 110132300
Idiopathic pulmonary fibrosis 13.02 10.99 20 108346 4984 110475949
Colitis 12.86 10.99 54 108312 102269 110378664
Respiratory tract congestion 12.76 10.99 62 108304 30795 110450138
Expiratory reserve volume decreased 12.72 10.99 5 108361 147 110480786
Left ventricular hypertrophy 12.70 10.99 35 108331 13209 110467724
Joint dislocation 12.68 10.99 9 108357 34181 110446752
Impaired work ability 12.67 10.99 5 108361 26414 110454519
Erythema 12.65 10.99 205 108161 291242 110189691
Alanine aminotransferase increased 12.64 10.99 117 108249 183656 110297277
Pain in extremity 12.64 10.99 372 107994 486746 109994187
Atelectasis 12.58 10.99 70 108296 36642 110444291
Pleural thickening 12.44 10.99 16 108350 3383 110477550
Confusional state 12.39 10.99 357 108009 468323 110012610
Oesophageal irritation 12.30 10.99 6 108360 299 110480634
Odynophagia 12.29 10.99 36 108330 14065 110466868
Injection site erythema 12.27 10.99 49 108317 94127 110386806
Hepatic cytolysis 12.22 10.99 22 108344 55031 110425902
Fluid replacement 12.16 10.99 9 108357 964 110479969
Photophobia 12.16 10.99 5 108361 25766 110455167
Therapeutic product effect prolonged 12.15 10.99 8 108358 710 110480223
Pancytopenia 12.14 10.99 139 108227 209474 110271459
Product administration error 12.12 10.99 70 108296 37147 110443786
Infantile haemangioma 12.11 10.99 3 108363 17 110480916
Haemophagocytic lymphohistiocytosis 12.11 10.99 8 108358 31551 110449382
Tongue exfoliation 12.04 10.99 5 108361 170 110480763
Idiopathic intracranial hypertension 12.02 10.99 17 108349 3935 110476998
Hypercholesterolaemia 12.00 10.99 47 108319 90790 110390143
Pancreatitis 11.98 10.99 49 108317 93484 110387449
Lymphopenia 11.96 10.99 13 108353 40157 110440776
Oral candidiasis 11.95 10.99 80 108286 44680 110436253
Presbyopia 11.94 10.99 8 108358 731 110480202
Burn oral cavity 11.79 10.99 5 108361 179 110480754
Oedema 11.49 10.99 141 108225 209835 110271098
Pneumocystis jirovecii pneumonia 11.48 10.99 15 108351 42720 110438213
Transient ischaemic attack 11.34 10.99 104 108262 63878 110417055
Hepatic steatosis 11.30 10.99 19 108347 48812 110432121
Type 2 diabetes mellitus 11.28 10.99 115 108251 177117 110303816
Intentional self-injury 11.27 10.99 12 108354 37417 110443516
Serotonin syndrome 11.12 10.99 26 108340 59127 110421806
Immunodeficiency 11.10 10.99 13 108353 38825 110442108
Pharyngeal mass 11.05 10.99 6 108360 374 110480559
Metastases to liver 11.05 10.99 11 108355 35375 110445558
Aplastic anaemia 11.02 10.99 5 108361 24303 110456630

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R01AX03 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Other nasal preparations
ATC R03AL01 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03AL02 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03BB01 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 D001993 Bronchodilator Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018678 Cholinergic Agents
MeSH PA D018680 Cholinergic Antagonists
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D019141 Respiratory System Agents
CHEBI has role CHEBI:35523 bronchodilator agent
CHEBI has role CHEBI:48876 muscarinic antagonist
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:53784 antispasmodic drug
CHEBI has role CHEBI:77715 nasal decongestant

Related Drugs by ATC class:

R01AX Other nasal preparations 6 drugs
framycetinhexamidinehyaluronic acidmupirocinretinolritiometan
R03AL Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids 14 drugs
aclidinium bromidebeclometasone dipropionatebudesonidefenoterolfluticasone furoateformoterolglycopyrronium bromideindacaterolmometasone furoateolodaterolsalbutamoltiotropium bromide show all 14 →
R03BB Anticholinergics 6 drugs
aclidinium bromideglycopyrronium bromideoxitropiumrevefenacintiotropium bromideumeclidinium

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

DiseaseRelationSNOMED_IDDOID
Bronchospasm indication 4386001
Chronic obstructive lung disease indication 13645005 DOID:3083
Bronchitis indication 32398004 DOID:6132
Allergic rhinitis indication 61582004
Nasal discharge indication 64531003
Pulmonary emphysema indication 87433001
Chronic Obstructive Pulmonary Disease with Bronchospasms indication
Asthma off-label use 195967001 DOID:2841
Asthma-chronic obstructive pulmonary disease overlap syndrome off-label use 10692761000119107
Ocular hypertension contraindication 4210003 DOID:9282
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Hypokalemia contraindication 43339004
Conduction disorder of the heart contraindication 44808001
Ketoacidosis contraindication 56051008
Metabolic acidosis contraindication 59455009
Diabetes mellitus contraindication 73211009 DOID:9351
Paradoxical bronchospasm contraindication 102578005
Prolonged QT interval contraindication 111975006
Seizure disorder contraindication 128613002
Bladder outflow obstruction contraindication 236645006
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Myocardial ischemia contraindication 414795007 DOID:3393
Congenital long QT syndrome contraindication 442917000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.24 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.021MG/INH IPRATROPIUM BROMIDE ARMSTRONG PHARMS A217953 Feb. 23, 2026 RX AEROSOL, METERED INHALATION Oct. 13, 2026 PATENT CHALLENGE

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Muscarinic acetylcholine receptor M3 GPCR ANTAGONIST Ki 9.29 WOMBAT-PK CHEMBL
Muscarinic acetylcholine receptor M2 GPCR Ki 8.82 WOMBAT-PK
Muscarinic acetylcholine receptor M4 GPCR Ki 9.18 WOMBAT-PK
Muscarinic acetylcholine receptor M5 GPCR Ki 8.77 WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR Ki 9.31 WOMBAT-PK
Solute carrier family 22 member 2 Transporter IC50 4.82 WOMBAT-PK
Muscarinic acetylcholine receptor M2 GPCR Ki 9.11 CHEMBL
Muscarinic acetylcholine receptor M1 GPCR Ki 9.54 CHEMBL
Muscarinic acetylcholine receptor M3 GPCR Ki 9.74 CHEMBL

External reference:

IDSource
4019791 VUID
N0000147880 NUI
D02212 KEGG_DRUG
66985-17-9 SECONDARY_CAS_RN
4019341 VANDF
4019791 VANDF
C0027235 UMLSCUI
CHEBI:5956 CHEBI
X8M PDB_CHEM_ID
CHEMBL1621597 ChEMBL_ID
CHEMBL2134724 ChEMBL_ID
DB00332 DRUGBANK_ID
D009241 MESH_DESCRIPTOR_UI
657309 PUBCHEM_CID
325 IUPHAR_LIGAND_ID
GR88G0I6UL UNII
1309404 RXNORM
4916 MMSL
6256 MMSL
d00265 MMSL
001750 NDDF
004943 NDDF
108624006 SNOMEDCT_US
372518007 SNOMEDCT_US
386881005 SNOMEDCT_US
725862005 SNOMEDCT_US
GR88G0I6UL INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 0054-0045 SPRAY 21 ug NASAL ANDA 3 sections
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 0054-0046 SPRAY 42 ug NASAL ANDA 16 sections
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 0378-7970 SOLUTION 0.50 mg RESPIRATORY (INHALATION) ANDA 22 sections
Ipratropium Bromide and Albuterol Sulfate HUMAN PRESCRIPTION DRUG LABEL 2 0378-9671 SOLUTION 0.50 mg RESPIRATORY (INHALATION) ANDA 28 sections
Ipratropium Bromide and Albuterol Sulfate HUMAN PRESCRIPTION DRUG LABEL 2 0487-0201 SOLUTION 0.50 mg RESPIRATORY (INHALATION) ANDA 29 sections
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 0487-9801 SOLUTION 0.50 mg RESPIRATORY (INHALATION) ANDA 22 sections
Combivent Respimat HUMAN PRESCRIPTION DRUG LABEL 2 0597-0024 SPRAY, METERED 20 ug RESPIRATORY (INHALATION) NDA 27 sections
AtroventHFA HUMAN PRESCRIPTION DRUG LABEL 1 0597-0087 AEROSOL, METERED 17 ug RESPIRATORY (INHALATION) NDA 29 sections
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 0781-7157 SOLUTION 0.50 mg RESPIRATORY (INHALATION) ANDA 23 sections
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 16714-526 SPRAY, METERED 21 ug NASAL ANDA 24 sections
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 16714-527 SPRAY, METERED 42 ug NASAL ANDA 25 sections
Ipratropium Bromide Inhalation HUMAN PRESCRIPTION DRUG LABEL 1 17270-0401 AEROSOL 17 ug RESPIRATORY (INHALATION) ANDA 18 sections
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 21695-911 SOLUTION 0.50 mg RESPIRATORY (INHALATION) ANDA 21 sections
Ipratropium bromide HUMAN PRESCRIPTION DRUG LABEL 1 24208-398 SPRAY, METERED 21 ug NASAL ANDA 27 sections
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 24208-399 SPRAY, METERED 42 ug NASAL ANDA 25 sections
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 42254-041 SOLUTION 0.50 mg RESPIRATORY (INHALATION) ANDA 19 sections
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 42254-355 SPRAY, METERED 42 ug NASAL ANDA 25 sections
Ipratropium Bromide Human Prescription Drug Label 1 47335-706 SOLUTION 0.50 mg RESPIRATORY (INHALATION) ANDA 19 sections
Ipratropium Bromide and Albuterol Sulfate Human Prescription Drug Label 2 47335-756 SOLUTION 0.50 mg RESPIRATORY (INHALATION) ANDA 22 sections
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 50090-0668 SOLUTION 0.50 mg RESPIRATORY (INHALATION) ANDA 21 sections
AtroventHFA HUMAN PRESCRIPTION DRUG LABEL 1 50090-0961 AEROSOL, METERED 17 ug RESPIRATORY (INHALATION) NDA 26 sections
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE HUMAN PRESCRIPTION DRUG LABEL 2 50090-1382 SOLUTION 0.50 mg RESPIRATORY (INHALATION) ANDA 26 sections
Ipratropium Bromide and Albuterol Sulfate HUMAN PRESCRIPTION DRUG LABEL 2 50090-1669 SOLUTION 0.50 mg RESPIRATORY (INHALATION) ANDA 29 sections
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 50090-4185 SOLUTION 0.50 mg RESPIRATORY (INHALATION) ANDA 22 sections
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 50090-5968 SPRAY, METERED 42 ug NASAL ANDA 24 sections
Ipratropium Bromide and Albuterol Sulfate Human Prescription Drug Label 2 50090-6288 SOLUTION 0.50 mg RESPIRATORY (INHALATION) ANDA 22 sections
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 50090-6373 SOLUTION 0.50 mg RESPIRATORY (INHALATION) ANDA 21 sections
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 53002-7880 SPRAY, METERED 42 ug NASAL ANDA 25 sections
AtroventHFA HUMAN PRESCRIPTION DRUG LABEL 1 53002-8410 AEROSOL, METERED 17 ug RESPIRATORY (INHALATION) NDA 28 sections
Ipratropium Bromide HUMAN PRESCRIPTION DRUG LABEL 1 53217-008 SOLUTION 0.50 mg RESPIRATORY (INHALATION) ANDA 22 sections