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

Stem definitionDrug idCAS RN
steroids not used as glucocorticosteroids 1225 80474-14-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fluticasone proprionate
  • fluticasone propionate
  • flixotide
  • fluticasone 17-propionate
A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS. It has received approval to be used in combination with salmeterol.
  • Molecular weight: 500.57
  • Formula: C25H31F3O5S
  • CLOGP: 4.03
  • LIPINSKI: 1
  • HAC: 5
  • HDO: 1
  • TPSA: 80.67
  • ALOGS: -4.64
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.20 mg N
0.60 mg Inhal.aerosol
0.60 mg Inhal.powder
1.50 mg Inhal.solution

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 0.00 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 3 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.65 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 1 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 3.60 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 17 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.10 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 6 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
March 26, 2021 EMA TEVA B.V.
Dec. 14, 1990 FDA FOUGERA PHARMS
June 29, 2020 PMDA Kyorin Pharmaceutical Co., Ltd.

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 869.52 10.07 1297 153456 126264 63208005
Synovitis 370.60 10.07 21 154732 186897 63147372
Systemic lupus erythematosus 336.99 10.07 53 154700 208865 63125404
Hand deformity 335.40 10.07 12 154741 159445 63174824
Cough 324.05 10.07 1492 153261 291251 63043018
Completed suicide 320.98 10.07 7 154746 145666 63188603
Contraindicated product administered 317.40 10.07 71 154682 217577 63116692
Wheezing 311.47 10.07 707 154046 94888 63239381
Toxicity to various agents 291.38 10.07 119 154634 247131 63087138
Glossodynia 282.58 10.07 48 154705 178828 63155441
Infective pulmonary exacerbation of cystic fibrosis 276.70 10.07 204 154549 8613 63325656
Dyspnoea 260.07 10.07 2604 152149 658709 62675560
Arthropathy 232.98 10.07 142 154611 234650 63099619
Sinusitis 232.88 10.07 1131 153622 225522 63108747
Chest discomfort 230.09 10.07 689 154064 109280 63224989
Wound 228.62 10.07 58 154695 163205 63171064
Bronchitis 226.65 10.07 745 154008 124190 63210079
Drug intolerance 204.37 10.07 272 154481 308389 63025880
Pericarditis 204.07 10.07 37 154716 131542 63202727
Treatment failure 196.56 10.07 121 154632 198922 63135347
Therapeutic product effect decreased 195.60 10.07 114 154639 193073 63141196
Alopecia 192.06 10.07 330 154423 337206 62997063
Maternal exposure during pregnancy 180.89 10.07 162 154591 219900 63114369
Macular degeneration 174.54 10.07 254 154499 24122 63310147
General physical health deterioration 174.41 10.07 141 154612 201261 63133008
Helicobacter infection 173.36 10.07 14 154739 92771 63241498
Product dose omission issue 173.05 10.07 1069 153684 233244 63101025
Chronic obstructive pulmonary disease 166.92 10.07 429 154324 62257 63272012
Off label use 161.07 10.07 975 153778 673487 62660782
Joint swelling 155.66 10.07 356 154397 327310 63006959
Hepatic enzyme increased 152.30 10.07 161 154592 202167 63132102
Eosinophilic granulomatosis with polyangiitis 150.04 10.07 83 154670 2109 63332160
Product quality issue 146.51 10.07 291 154462 35574 63298695
Chronic sinusitis 142.29 10.07 166 154587 12677 63321592
Folliculitis 142.10 10.07 7 154746 70310 63263959
Muscle injury 140.62 10.07 4 154749 65341 63268928
Upper respiratory tract infection 137.87 10.07 477 154276 81570 63252699
Obstructive airways disorder 135.75 10.07 207 154546 20492 63313777
Pneumonia 125.99 10.07 1681 153072 455086 62879183
Nasal congestion 125.72 10.07 399 154354 65261 63269008
Drug ineffective 124.58 10.07 1798 152955 1042967 62291302
Sleep apnoea syndrome 120.95 10.07 238 154515 28895 63305374
Neutropenia 120.05 10.07 150 154603 174855 63159414
Swelling 116.82 10.07 317 154436 275061 63059208
Discomfort 116.34 10.07 142 154611 167232 63167037
Anxiety 106.83 10.07 900 153853 216641 63117628
Intentional overdose 106.37 10.07 25 154728 74127 63260142
Sleep disorder due to general medical condition, insomnia type 100.02 10.07 7 154746 52210 63282059
Productive cough 99.74 10.07 360 154393 62848 63271421
Sputum increased 98.34 10.07 66 154687 2393 63331876
Liver injury 98.29 10.07 15 154738 60505 63273764
Abdominal discomfort 94.10 10.07 432 154321 320453 63013816
Drug abuse 91.86 10.07 31 154722 72487 63261782
Rheumatoid arthritis 89.33 10.07 318 154435 253501 63080768
Blister 89.28 10.07 111 154642 129703 63204566
Seasonal allergy 89.21 10.07 173 154580 20777 63313492
Impaired healing 84.76 10.07 75 154678 102467 63231802
Dysphonia 80.98 10.07 278 154475 47336 63286933
Febrile neutropenia 78.64 10.07 104 154649 118345 63215924
Feeling abnormal 77.66 10.07 623 154130 147769 63186500
Musculoskeletal stiffness 74.18 10.07 218 154535 184400 63149869
Acute kidney injury 70.04 10.07 367 154386 263048 63071221
Adrenal suppression 68.82 10.07 37 154716 887 63333382
Dermatitis atopic 67.68 10.07 100 154653 9624 63324645
Product complaint 67.49 10.07 116 154637 12693 63321576
Sleep disorder due to a general medical condition 66.36 10.07 112 154641 12076 63322193
Malignant neoplasm progression 65.56 10.07 62 154691 82059 63252210
Hepatotoxicity 65.41 10.07 7 154746 37034 63297235
Leukopenia 64.51 10.07 56 154697 77234 63257035
Bronchial neoplasm 64.14 10.07 29 154724 471 63333798
Nasal polyps 63.49 10.07 76 154677 5963 63328306
Dyspnoea exertional 63.26 10.07 303 154450 59999 63274270
Bronchial haemorrhage 62.48 10.07 30 154723 562 63333707
Migraine 61.96 10.07 448 154305 102898 63231371
Gastrooesophageal reflux disease 60.49 10.07 420 154333 95219 63239050
Pancytopenia 60.45 10.07 89 154664 96844 63237425
Rhinorrhoea 59.98 10.07 317 154436 65260 63269009
Ear infection 59.72 10.07 217 154536 37996 63296273
Drug interaction 59.36 10.07 322 154431 228809 63105460
Headache 58.49 10.07 1985 152768 631256 62703013
Nasal turbinate hypertrophy 58.08 10.07 31 154722 732 63333537
Oropharyngeal pain 57.45 10.07 411 154342 94076 63240193
Thrombocytopenia 56.79 10.07 184 154569 150973 63183296
Salpingo-oophorectomy unilateral 56.60 10.07 32 154721 849 63333420
Illness 56.24 10.07 253 154500 48806 63285463
Respiratory symptom 56.22 10.07 54 154699 3293 63330976
Mucosal inflammation 56.15 10.07 22 154731 46906 63287363
Infusion related reaction 55.67 10.07 360 154393 245161 63089108
Sinus disorder 55.27 10.07 158 154595 24395 63309874
Cystic fibrosis 55.03 10.07 53 154700 3243 63331026
Coma 54.49 10.07 46 154707 64318 63269951
Sinusitis fungal 54.40 10.07 41 154712 1790 63332479
Impaired quality of life 52.90 10.07 109 154644 13674 63320595
Infusion site erythema 52.87 10.07 99 154654 11580 63322689
C-reactive protein increased 52.45 10.07 94 154659 94613 63239656
Emphysema 52.39 10.07 95 154658 10843 63323426
Pulmonary function test decreased 52.27 10.07 56 154697 3891 63330378
Rhonchi 51.89 10.07 46 154707 2530 63331739
Emotional distress 51.85 10.07 186 154567 32363 63301906
Female genital tract fistula 51.55 10.07 77 154676 7482 63326787
Embolism venous 51.31 10.07 50 154703 3104 63331165
Irritable bowel syndrome 51.06 10.07 76 154677 82336 63251933
Depression 51.03 10.07 716 154037 195776 63138493
Mobility decreased 50.90 10.07 140 154613 121019 63213250
Infusion site swelling 50.85 10.07 88 154665 9682 63324587
Procedural pain 50.70 10.07 141 154612 21428 63312841
Influenza 50.25 10.07 444 154309 108278 63225991
Chest pain 50.22 10.07 772 153981 215187 63119082
Bronchial disorder 50.09 10.07 34 154719 1256 63333013
Forced expiratory volume decreased 49.75 10.07 61 154692 4907 63329362
Viral infection 49.51 10.07 195 154558 35468 63298801
Endometrial ablation 48.76 10.07 30 154723 934 63333335
Diverticulum 48.60 10.07 97 154656 11894 63322375
Intentional product use issue 48.51 10.07 155 154598 127737 63206532
Eczema 48.47 10.07 181 154572 32110 63302159
Food allergy 48.36 10.07 94 154659 11307 63322962
Prolonged expiration 47.67 10.07 31 154722 1065 63333204
Paraesthesia oral 47.37 10.07 128 154625 19128 63315141
Drug reaction with eosinophilia and systemic symptoms 47.36 10.07 12 154741 33824 63300445
COVID-19 47.26 10.07 452 154301 112651 63221618
Hepatic function abnormal 46.82 10.07 16 154737 37126 63297143
Rhinitis 46.14 10.07 92 154661 11274 63322995
Gamma-glutamyltransferase increased 45.87 10.07 13 154740 34018 63300251
Acute respiratory failure 45.82 10.07 186 154567 34299 63299970
Sputum discoloured 44.65 10.07 113 154640 16234 63318035
Gastrointestinal disorder 44.42 10.07 167 154586 131072 63203197
Oesophageal spasm 44.37 10.07 46 154707 3077 63331192
Product use issue 43.78 10.07 336 154417 220184 63114085
Concussion 42.65 10.07 79 154674 9165 63325104
Confusional state 42.44 10.07 370 154383 236010 63098259
Cholecystitis chronic 42.22 10.07 84 154669 10277 63323992
Rheumatoid factor positive 42.20 10.07 89 154664 84317 63249952
Full blood count abnormal 42.09 10.07 171 154582 31546 63302723
Infusion site pruritus 41.91 10.07 62 154691 5973 63328296
Infusion site extravasation 41.85 10.07 84 154669 10342 63323927
Cushing's syndrome 41.58 10.07 24 154729 663 63333606
Urinary tract infection 41.37 10.07 889 153864 263795 63070474
Candida infection 40.97 10.07 157 154596 28194 63306075
Metabolic acidosis 40.94 10.07 30 154723 45039 63289230
Eye pruritus 40.91 10.07 119 154634 18552 63315717
Nasal discomfort 40.65 10.07 54 154699 4706 63329563
Dermatitis allergic 40.64 10.07 104 154649 15044 63319225
Multiple organ dysfunction syndrome 40.62 10.07 47 154706 56705 63277564
Cardio-respiratory arrest 40.44 10.07 52 154701 59907 63274362
Multiple allergies 40.44 10.07 98 154655 13704 63320565
Palpitations 40.10 10.07 436 154317 112334 63221935
Diastolic dysfunction 40.03 10.07 63 154690 6408 63327861
Pre-existing condition improved 38.72 10.07 71 154682 8173 63326096
Anosmia 38.63 10.07 64 154689 6796 63327473
Infusion site pain 38.40 10.07 109 154644 16760 63317509
Deep vein thrombosis 38.08 10.07 341 154412 83459 63250810
Oesophageal pain 37.96 10.07 46 154707 3655 63330614
Upper-airway cough syndrome 37.74 10.07 85 154668 11333 63322936
Toxic epidermal necrolysis 37.41 10.07 8 154745 25326 63308943
Fluid retention 37.07 10.07 261 154492 59425 63274844
Heart sounds 35.73 10.07 25 154728 971 63333298
Infusion site haemorrhage 34.96 10.07 52 154701 5034 63329235
Depressed level of consciousness 34.92 10.07 61 154692 62017 63272252
Hiatus hernia 34.91 10.07 124 154629 21470 63312799
Hip arthroplasty 34.60 10.07 39 154714 47607 63286662
Bone marrow failure 34.60 10.07 14 154739 29276 63304993
Rhinitis allergic 34.07 10.07 83 154670 11644 63322625
Myelosuppression 33.97 10.07 8 154745 23695 63310574
Dizziness 33.55 10.07 1323 153430 428602 62905667
Increased upper airway secretion 33.44 10.07 43 154710 3629 63330640
Foetal death 33.28 10.07 79 154674 10901 63323368
Cholestasis 33.28 10.07 15 154738 29419 63304850
Suicide attempt 33.24 10.07 61 154692 60857 63273412
Agranulocytosis 33.15 10.07 10 154743 25124 63309145
Acute sinusitis 33.04 10.07 44 154709 3843 63330426
Bladder prolapse 32.89 10.07 33 154720 2123 63332146
Pruritus 32.47 10.07 1130 153623 360323 62973946
Live birth 32.38 10.07 11 154742 25619 63308650
Pulmonary embolism 32.23 10.07 430 154323 116254 63218015
Stress 31.90 10.07 276 154477 66891 63267378
Tinnitus 31.73 10.07 171 154582 35457 63298812
Ectropion 31.08 10.07 13 154740 173 63334096
Foetal exposure during pregnancy 30.72 10.07 20 154733 31942 63302327
Pulmonary mass 30.12 10.07 122 154631 22474 63311795
Respiratory tract infection 29.74 10.07 188 154565 41295 63292974
Ill-defined disorder 29.67 10.07 101 154652 81654 63252615
Hysterectomy 29.51 10.07 69 154684 9430 63324839
Tricuspid valve incompetence 29.02 10.07 90 154663 14531 63319738
Type 2 diabetes mellitus 28.96 10.07 71 154682 63797 63270472
Therapeutic response unexpected 28.86 10.07 106 154647 18653 63315616
Posterior reversible encephalopathy syndrome 28.85 10.07 4 154749 17341 63316928
Disease progression 28.30 10.07 179 154574 122579 63211690
Eosinophil count increased 28.26 10.07 74 154679 10854 63323415
Renal impairment 28.25 10.07 115 154638 88240 63246029
Hereditary angioedema 28.08 10.07 59 154694 7503 63326766
Hyponatraemia 27.99 10.07 159 154594 111741 63222528
Platelet count decreased 27.98 10.07 167 154586 115955 63218314
Electrocardiogram QT prolonged 27.93 10.07 65 154688 59465 63274804
Pneumocystis jirovecii pneumonia 27.90 10.07 4 154749 16910 63317359
Hepatocellular injury 27.90 10.07 16 154737 27365 63306904
Drug hypersensitivity 27.50 10.07 563 154190 310124 63024145
Adrenal insufficiency 27.37 10.07 101 154652 17814 63316455
Blood cholesterol increased 27.25 10.07 127 154626 93905 63240364
Anaemia 26.79 10.07 529 154224 292901 63041368
Weight decreased 26.78 10.07 873 153880 275925 63058344
Poor quality device used 26.75 10.07 29 154724 2042 63332227
Therapy non-responder 26.71 10.07 95 154658 75806 63258463
Bronchial obstruction 26.62 10.07 25 154728 1482 63332787
Cytomegalovirus infection 26.45 10.07 9 154744 20943 63313326
Status asthmaticus 26.32 10.07 20 154733 884 63333385
Rheumatoid nodule 26.20 10.07 5 154748 17150 63317119
Serotonin syndrome 26.17 10.07 19 154734 28663 63305606
Rectal prolapse 26.02 10.07 28 154725 1955 63332314
Overdose 25.91 10.07 169 154584 114909 63219360
Stomatitis 25.83 10.07 215 154538 138510 63195759
Hypotension 25.63 10.07 489 154264 272115 63062154
Affective disorder 25.25 10.07 50 154703 6096 63328173
Cor pulmonale 25.21 10.07 28 154725 2026 63332243
Breath sounds abnormal 25.07 10.07 71 154682 10902 63323367
Granuloma 25.04 10.07 48 154705 5713 63328556
Nasal mucosal disorder 24.76 10.07 15 154738 454 63333815
Neutrophil count decreased 24.57 10.07 64 154689 56342 63277927
Inflammation 24.51 10.07 110 154643 82163 63252106
Premature baby 24.34 10.07 10 154743 20725 63313544
Premature delivery 24 10.07 23 154730 30258 63304011
Burning sensation 24.00 10.07 220 154533 54187 63280082
Altered state of consciousness 23.96 10.07 16 154737 25214 63309055
Bone erosion 23.88 10.07 96 154657 17621 63316648
Eosinophilic pneumonia chronic 23.87 10.07 11 154742 187 63334082
Oxygen saturation decreased 23.86 10.07 325 154428 88260 63246009
Death 23.74 10.07 713 154040 373668 62960601
Iron deficiency anaemia 23.65 10.07 104 154649 19865 63314404
Oropharyngeal oedema 23.30 10.07 13 154740 336 63333933
Infusion site bruising 23.28 10.07 37 154716 3795 63330474
Poisoning 23.17 10.07 3 154750 13697 63320572
Arthralgia 23.14 10.07 1144 153609 568566 62765703
Infusion site nodule 23.06 10.07 23 154730 1469 63332800
Peak expiratory flow rate decreased 23.06 10.07 16 154737 613 63333656
Dermatitis contact 23.01 10.07 69 154684 10939 63323330
Hospitalisation 22.85 10.07 312 154441 84769 63249500
Expiratory reserve volume decreased 22.84 10.07 7 154746 34 63334235
Interstitial lung disease 22.79 10.07 76 154677 61832 63272437
Neutropenic sepsis 22.68 10.07 6 154747 16432 63317837
Throat irritation 22.43 10.07 163 154590 37484 63296785
Surgery 22.27 10.07 157 154596 35755 63298514
Oesophagogastroduodenoscopy 22.19 10.07 10 154743 161 63334108
Ankle fracture 21.91 10.07 94 154659 17761 63316508
Aphonia 21.91 10.07 64 154689 9999 63324270
Inhalation therapy 21.90 10.07 7 154746 40 63334229
Blood creatinine increased 21.87 10.07 125 154628 87719 63246550
Vaginal flatulence 21.68 10.07 33 154720 3260 63331009
Hypokalaemia 21.61 10.07 156 154597 103648 63230621
Sinus operation 21.57 10.07 29 154724 2557 63331712
Swelling face 21.45 10.07 243 154510 63232 63271037
Myocardial infarction 21.26 10.07 352 154401 99541 63234728
Lymphopenia 21.26 10.07 9 154744 18318 63315951
Pulmonary hypertension 21.13 10.07 159 154594 36964 63297305
Vision blurred 21.09 10.07 328 154425 91596 63242673
Haemoptysis 21.09 10.07 131 154622 28595 63305674
Cardiac failure 21.05 10.07 129 154624 89013 63245256
Joint range of motion decreased 20.97 10.07 29 154724 32399 63301870
Tooth infection 20.97 10.07 93 154660 17827 63316442
Circulatory collapse 20.72 10.07 14 154739 21924 63312345
Bronchitis bacterial 20.61 10.07 17 154736 847 63333422
Bradycardia 20.57 10.07 100 154653 73127 63261142
Blood immunoglobulin E increased 20.46 10.07 35 154718 3814 63330455
Drug-induced liver injury 20.45 10.07 42 154711 40180 63294089
Biliary dyskinesia 20.35 10.07 29 154724 2700 63331569
Hyperkalaemia 20.33 10.07 66 154687 54137 63280132
Respiratory arrest 20.32 10.07 30 154723 32615 63301654
Drug eruption 20.28 10.07 24 154729 28670 63305599
Croup infectious 20.25 10.07 14 154739 533 63333736
Mite allergy 20.10 10.07 15 154738 645 63333624
Peripheral swelling 20.08 10.07 494 154259 265448 63068821
Exposure during pregnancy 19.99 10.07 263 154490 155284 63178985
Ear discomfort 19.90 10.07 53 154700 7853 63326416
Limb injury 19.86 10.07 118 154635 25359 63308910
Red blood cell sedimentation rate increased 19.85 10.07 49 154704 43933 63290336
Hypoxia 19.80 10.07 228 154525 59564 63274705
Anaphylactic reaction 19.67 10.07 247 154506 65853 63268416
Knee arthroplasty 19.64 10.07 67 154686 54139 63280130
Arthropod bite 19.59 10.07 53 154700 7925 63326344
Influenza like illness 19.59 10.07 249 154504 66575 63267694
Fungal infection 19.36 10.07 155 154598 36719 63297550
Eosinophil count abnormal 19.34 10.07 14 154739 574 63333695
Hypervolaemia 19.28 10.07 127 154626 28286 63305983
Throat tightness 19.23 10.07 115 154638 24772 63309497
Psoriasis 19.09 10.07 308 154445 86649 63247620
Middle insomnia 19.08 10.07 71 154682 12572 63321697
Jaundice 19.08 10.07 26 154727 29225 63305044
Metastases to bone 19.08 10.07 14 154739 21005 63313264
Blood lactate dehydrogenase increased 18.98 10.07 17 154736 23099 63311170
Radiculopathy 18.98 10.07 55 154698 8556 63325713
Dry skin 18.87 10.07 217 154536 56670 63277599
Back pain 18.75 10.07 805 153948 263340 63070929
Urticaria 18.71 10.07 533 154220 165269 63169000
Vaginal discharge 18.61 10.07 57 154696 9141 63325128
FEV1/FVC ratio decreased 18.51 10.07 8 154745 116 63334153
Insurance issue 18.51 10.07 44 154709 6077 63328192
Throat clearing 18.48 10.07 26 154727 2393 63331876
Growth failure 18.30 10.07 11 154742 328 63333941
Respiration abnormal 18.20 10.07 45 154708 6372 63327897
Insomnia 18.07 10.07 668 154085 214584 63119685
Oral candidiasis 18.03 10.07 106 154647 22692 63311577
Coeliac disease 17.78 10.07 70 154683 12727 63321542
Neck pain 17.72 10.07 252 154501 69066 63265203
Cystic fibrosis related diabetes 17.62 10.07 6 154747 43 63334226
Sinus congestion 17.53 10.07 89 154664 18034 63316235
Bronchospasm 17.52 10.07 86 154667 17194 63317075
Nodular vasculitis 17.51 10.07 5 154748 18 63334251
Thyroid atrophy 17.51 10.07 5 154748 18 63334251
Drug resistance 17.51 10.07 18 154735 22915 63311354
Acute generalised exanthematous pustulosis 17.46 10.07 3 154750 11096 63323173
Muscle spasms 17.35 10.07 501 154252 155649 63178620
Lip dry 17.31 10.07 8 154745 15462 63318807
Rales 17.28 10.07 69 154684 12628 63321641
Shock 17.26 10.07 19 154734 23444 63310825
Neurotoxicity 17.21 10.07 10 154743 16980 63317289
Gallbladder disorder 17.16 10.07 91 154662 18751 63315518
Cellulitis 17.14 10.07 288 154465 81670 63252599
Product administration interrupted 17.11 10.07 37 154716 4799 63329470
Lymphoedema 17.10 10.07 65 154688 11627 63322642
Foot deformity 16.94 10.07 26 154727 27827 63306442
Malaise 16.92 10.07 1204 153549 414750 62919519
Wrong technique in device usage process 16.91 10.07 31 154722 3567 63330702
Fracture displacement 16.89 10.07 18 154735 1243 63333026
Anhedonia 16.87 10.07 62 154691 10912 63323357
Epilepsy 16.72 10.07 25 154728 27040 63307229
Sinus headache 16.58 10.07 40 154713 5576 63328693
Anuria 16.54 10.07 5 154748 12546 63321723
Palmar-plantar erythrodysaesthesia syndrome 16.53 10.07 19 154734 22996 63311273
Therapy partial responder 16.50 10.07 3 154750 10655 63323614
Middle ear effusion 16.45 10.07 25 154728 2466 63331803
Proctitis 16.33 10.07 39 154714 5402 63328867
Alanine aminotransferase increased 16.22 10.07 168 154585 103602 63230667
Sedation 16.17 10.07 45 154708 38764 63295505
Respiratory tract congestion 16.16 10.07 86 154667 17746 63316523
Asthmatic crisis 16.15 10.07 21 154732 1792 63332477
Gastroenteritis viral 16.12 10.07 106 154647 23594 63310675
Lemierre syndrome 16.10 10.07 7 154746 103 63334166
Exercise tolerance decreased 16.07 10.07 39 154714 5458 63328811
Condition aggravated 16.04 10.07 809 153944 401408 62932861
Rash 16.03 10.07 1164 153589 559707 62774562
Breast cancer stage III 15.92 10.07 3 154750 10383 63323886
Heart rate increased 15.82 10.07 320 154433 93918 63240351
Inappropriate antidiuretic hormone secretion 15.80 10.07 9 154744 15453 63318816
Facet joint syndrome 15.70 10.07 5 154748 12133 63322136
Dystonia 15.69 10.07 7 154746 13812 63320457
Lupus-like syndrome 15.49 10.07 9 154744 15286 63318983
Infusion site mass 15.46 10.07 22 154731 2046 63332223
Stevens-Johnson syndrome 15.46 10.07 23 154730 24927 63309342
Pneumococcal infection 15.35 10.07 11 154742 444 63333825
Cortisol decreased 15.34 10.07 17 154736 1227 63333042
Hypothermia 15.23 10.07 7 154746 13574 63320695
Eosinophilic bronchitis 15.21 10.07 12 154741 561 63333708
Hepatic failure 15.11 10.07 41 154712 35615 63298654
Gallbladder injury 15.11 10.07 18 154735 1405 63332864
Ear canal erythema 15.06 10.07 3 154750 0 63334269
Wolff-Parkinson-White syndrome 14.93 10.07 7 154746 124 63334145
Total lung capacity abnormal 14.90 10.07 6 154747 72 63334197
Injury 14.81 10.07 256 154497 72991 63261278
Lactic acidosis 14.79 10.07 46 154707 38241 63296028
Psoriatic arthropathy 14.79 10.07 147 154606 91373 63242896
Obstruction 14.77 10.07 27 154726 3100 63331169
Tubulointerstitial nephritis 14.77 10.07 16 154737 19887 63314382
Transplant rejection 14.75 10.07 4 154749 10776 63323493
Thermal burn 14.68 10.07 40 154713 6006 63328263
Intentional self-injury 14.66 10.07 25 154728 25662 63308607
Gastrointestinal procedural complication 14.61 10.07 8 154745 199 63334070
Sneezing 14.60 10.07 85 154668 18133 63316136
Cholecystectomy 14.51 10.07 58 154695 10619 63323650
Gluten sensitivity 14.38 10.07 12 154741 608 63333661
Bronchial wall thickening 14.36 10.07 18 154735 1481 63332788
Temperature regulation disorder 14.32 10.07 40 154713 6092 63328177
Growth retardation 14.30 10.07 17 154736 1324 63332945
Injection site inflammation 14.29 10.07 30 154723 3813 63330456
Aspirin-exacerbated respiratory disease 14.21 10.07 14 154739 881 63333388
Aplastic anaemia 14.17 10.07 3 154750 9566 63324703
Tooth abscess 14.12 10.07 73 154680 14896 63319373
Depressive symptom 14.08 10.07 31 154722 4071 63330198
Bronchiectasis 14.05 10.07 77 154676 16065 63318204
Rash maculo-papular 14.03 10.07 36 154717 31860 63302409
Cardiac arrest 13.99 10.07 151 154602 92394 63241875
Periarthritis 13.97 10.07 22 154731 2239 63332030
Septic shock 13.93 10.07 100 154653 66529 63267740
Toxic skin eruption 13.90 10.07 7 154746 12878 63321391
Senile osteoporosis 13.86 10.07 8 154745 221 63334048
Haemophilus infection 13.82 10.07 16 154737 1211 63333058
Disease recurrence 13.74 10.07 116 154637 27914 63306355
Acute myeloid leukaemia 13.62 10.07 13 154740 17134 63317135
Conjunctivitis allergic 13.61 10.07 14 154739 928 63333341
Myalgia 13.59 10.07 460 154293 146069 63188200
Bronchospasm paradoxical 13.58 10.07 6 154747 92 63334177
Adjustment disorder with depressed mood 13.56 10.07 4 154749 10200 63324069
Rhabdomyolysis 13.55 10.07 58 154695 43893 63290376
Decreased appetite 13.55 10.07 488 154265 250564 63083705
Ulcer 13.49 10.07 27 154726 26080 63308189
Gammopathy 13.48 10.07 7 154746 156 63334113
Body temperature increased 13.45 10.07 46 154707 37146 63297123
Vitamin D decreased 13.41 10.07 55 154698 10187 63324082
Bronchial irritation 13.30 10.07 4 154749 18 63334251
Infusion site discomfort 13.27 10.07 17 154736 1429 63332840
Laryngeal pain 13.24 10.07 32 154721 4466 63329803
Hyperhidrosis 13.10 10.07 350 154403 107486 63226783
Drug level increased 13.10 10.07 22 154731 22714 63311555
Therapeutic product effect incomplete 13.01 10.07 398 154355 124658 63209611
Cardiovascular deconditioning 12.99 10.07 3 154750 3 63334266
Cytopenia 12.98 10.07 6 154747 11595 63322674
Musculoskeletal chest pain 12.97 10.07 92 154661 20991 63313278
Spinal operation 12.95 10.07 47 154706 8224 63326045
Abortion spontaneous 12.94 10.07 65 154688 47130 63287139
Osteoporosis 12.93 10.07 204 154549 57134 63277135
Respiratory disorder 12.92 10.07 149 154604 38933 63295336
Cystitis 12.91 10.07 197 154556 54794 63279475
Skin swelling 12.86 10.07 27 154726 3432 63330837
Hypothalamic pituitary adrenal axis suppression 12.83 10.07 7 154746 173 63334096
Muscle rigidity 12.78 10.07 6 154747 11494 63322775
Appetite disorder 12.67 10.07 43 154710 7278 63326991
Magnetic resonance imaging thoracic abnormal 12.64 10.07 4 154749 22 63334247
Diabetic ketoacidosis 12.61 10.07 19 154734 20486 63313783
Metastases to liver 12.60 10.07 24 154729 23615 63310654
Aspartate aminotransferase increased 12.58 10.07 150 154603 90127 63244142
Panniculitis 12.56 10.07 6 154747 11379 63322890
Neoplasm progression 12.55 10.07 46 154707 36382 63297887
Nasal septum deviation 12.47 10.07 17 154736 1519 63332750
Hypercalcaemia 12.44 10.07 32 154721 28290 63305979
Upper limb fracture 12.40 10.07 84 154669 18884 63315385
Chills 12.38 10.07 363 154390 113015 63221254
Pharyngeal abscess 12.30 10.07 8 154745 275 63333994
Stress fracture 12.25 10.07 45 154708 7918 63326351
Neck injury 12.23 10.07 20 154733 2101 63332168
Expired product administered 12.22 10.07 38 154715 6143 63328126
Pharyngitis streptococcal 12.20 10.07 55 154698 10617 63323652
Fracture 12.18 10.07 18 154735 19566 63314703
Atypical fracture 12.11 10.07 11 154742 625 63333644
Labelled drug-drug interaction medication error 12.06 10.07 9 154744 13390 63320879
Increased bronchial secretion 12.06 10.07 18 154735 1748 63332521
Lower respiratory tract infection 11.91 10.07 239 154514 132068 63202201
Enuresis 11.88 10.07 22 154731 2551 63331718
Glucocorticoids increased 11.88 10.07 6 154747 126 63334143
Cystitis interstitial 11.86 10.07 17 154736 1591 63332678
Otorrhoea 11.79 10.07 16 154737 1423 63332846
Pituitary-dependent Cushing's syndrome 11.78 10.07 3 154750 6 63334263
Paranasal sinus discomfort 11.69 10.07 30 154723 4346 63329923
Type V hyperlipidaemia 11.60 10.07 10 154743 530 63333739
Injection site haemorrhage 11.59 10.07 100 154653 24214 63310055
Epistaxis 11.57 10.07 245 154508 72480 63261789
Haemodynamic instability 11.51 10.07 4 154749 9186 63325083
Cardiac failure congestive 11.51 10.07 301 154452 92132 63242137
Renal failure 11.36 10.07 210 154543 117442 63216827
Oliguria 11.33 10.07 4 154749 9097 63325172
Eye infection 11.30 10.07 59 154694 12086 63322183
Product taste abnormal 11.26 10.07 19 154734 2048 63332221
Prescribed underdose 11.24 10.07 36 154717 29653 63304616
Memory impairment 11.16 10.07 333 154420 103925 63230344
Pregnancy 11.12 10.07 49 154704 36787 63297482
Purpura 11.11 10.07 7 154746 11378 63322891
Osteonecrosis of jaw 11.04 10.07 46 154707 35077 63299192
Respiratory tract irritation 11.02 10.07 9 154744 442 63333827
Facial pain 11.02 10.07 53 154700 10508 63323761
Spirometry abnormal 10.93 10.07 7 154746 234 63334035
Metastases to lung 10.93 10.07 9 154744 12741 63321528
Vena cava embolism 10.92 10.07 3 154750 9 63334260
Tracheobronchitis bacterial 10.92 10.07 3 154750 9 63334260
Atrial flutter 10.90 10.07 50 154703 9722 63324547
Influenza A virus test positive 10.82 10.07 8 154745 339 63333930
Rib fracture 10.80 10.07 93 154660 22504 63311765
Immunoglobulins increased 10.78 10.07 9 154744 456 63333813
Parkinsonism 10.78 10.07 6 154747 10433 63323836
Idiopathic angioedema 10.76 10.07 4 154749 38 63334231
Torsade de pointes 10.75 10.07 10 154743 13341 63320928
Grip strength decreased 10.72 10.07 24 154729 22263 63312006
Brain natriuretic peptide 10.67 10.07 4 154749 39 63334230
Body mass index increased 10.66 10.07 14 154739 1206 63333063
Hirsutism 10.66 10.07 15 154738 1380 63332889
Extrapyramidal disorder 10.63 10.07 10 154743 13274 63320995
Breast cancer stage II 10.61 10.07 4 154749 8732 63325537
Medical procedure 10.60 10.07 8 154745 350 63333919
Proteinuria 10.60 10.07 19 154734 19126 63315143
Hypertensive crisis 10.57 10.07 13 154740 15273 63318996
Fracture pain 10.52 10.07 11 154742 743 63333526
Coronary artery disease 10.51 10.07 123 154630 32254 63302015
Vocal cord atrophy 10.46 10.07 3 154750 11 63334258
Nephropathy toxic 10.45 10.07 5 154748 9474 63324795
Pulmonary toxicity 10.41 10.07 5 154748 9450 63324819
Snoring 10.40 10.07 28 154725 4174 63330095
Cataplexy 10.34 10.07 14 154739 1242 63333027
Palmoplantar keratoderma 10.34 10.07 18 154735 1989 63332280
Restless legs syndrome 10.34 10.07 79 154674 18452 63315817
Vulva cyst 10.33 10.07 4 154749 43 63334226
Pulmonary arterial hypertension 10.31 10.07 92 154661 22485 63311784
Nasal pruritus 10.31 10.07 9 154744 485 63333784
Transferrin saturation decreased 10.31 10.07 11 154742 761 63333508
Selective IgA immunodeficiency 10.26 10.07 3 154750 12 63334257
Hypercholesterolaemia 10.24 10.07 23 154730 21311 63312958
Blood pressure inadequately controlled 10.21 10.07 31 154722 4947 63329322
Joint stiffness 10.19 10.07 60 154693 41809 63292460
Incorrect dose administered 10.18 10.07 204 154549 59764 63274505
Ascites 10.11 10.07 58 154695 40670 63293599

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 672.23 10.56 606 68926 42050 34845349
Sinusitis 217.86 10.56 335 69197 41067 34846332
Toxicity to various agents 214.66 10.56 66 69466 200296 34687103
Wheezing 210.87 10.56 330 69202 41072 34846327
Infective pulmonary exacerbation of cystic fibrosis 189.21 10.56 135 69397 6666 34880733
Cough 183.39 10.56 685 68847 149455 34737944
Dyspnoea 162.13 10.56 1290 68242 375492 34511907
Eosinophilic granulomatosis with polyangiitis 146.79 10.56 74 69458 1913 34885486
Product dose omission issue 138.47 10.56 537 68995 119174 34768225
Productive cough 130.56 10.56 254 69278 37559 34849840
Adrenal suppression 123.40 10.56 47 69485 600 34886799
Completed suicide 113.09 10.56 28 69504 98140 34789259
Nasal congestion 98.70 10.56 170 69362 22887 34864512
Bronchitis 96.07 10.56 239 69293 41724 34845675
Nasal polyps 94.35 10.56 60 69472 2443 34884956
Acute kidney injury 90.52 10.56 308 69224 304680 34582719
Pneumonia 85.28 10.56 1097 68435 361530 34525869
Product quality issue 76.07 10.56 128 69404 16907 34870492
Chronic obstructive pulmonary disease 72.33 10.56 238 69294 48680 34838719
Thrombocytopenia 72.19 10.56 125 69407 156122 34731277
Cystic fibrosis 70.73 10.56 43 69489 1615 34885784
Sleep disorder due to a general medical condition 66.46 10.56 66 69466 5155 34882244
Full blood count abnormal 66.36 10.56 127 69405 18541 34868858
Product complaint 63.32 10.56 68 69464 5822 34881577
Off label use 59.64 10.56 541 68991 418983 34468416
Illness 59.53 10.56 101 69431 13428 34873971
Malignant neoplasm progression 56.53 10.56 55 69477 87991 34799408
Hypothalamic pituitary adrenal axis suppression 56.46 10.56 18 69514 129 34887270
Upper respiratory tract infection 55.42 10.56 168 69364 32891 34854508
Drug abuse 54.76 10.56 70 69462 99026 34788373
Sinus disorder 53.14 10.56 68 69464 7017 34880382
Neutropenia 52.25 10.56 150 69382 156628 34730771
Anaemia 52.03 10.56 263 69269 233072 34654327
Epidural lipomatosis 51.93 10.56 30 69502 1024 34886375
Cushingoid 51.64 10.56 43 69489 2671 34884728
Influenza 49.53 10.56 213 69319 49453 34837946
Rhinorrhoea 49.34 10.56 137 69395 25531 34861868
Victim of child abuse 47.32 10.56 27 69505 900 34886499
Dermatitis atopic 46.02 10.56 55 69477 5292 34882107
Forced expiratory volume decreased 45.49 10.56 43 69489 3160 34884239
Interstitial lung disease 45.22 10.56 38 69494 65244 34822155
Sputum discoloured 45.01 10.56 66 69466 7746 34879653
Vocal cord dysfunction 44.98 10.56 16 69516 166 34887233
Renal impairment 44.17 10.56 75 69457 94438 34792961
Upper-airway cough syndrome 43.49 10.56 44 69488 3514 34883885
Eosinophil count 43.49 10.56 15 69517 141 34887258
Chorioretinopathy 42.36 10.56 30 69502 1463 34885936
Intentional overdose 42.18 10.56 17 69515 43657 34843742
C-reactive protein increased 41.96 10.56 28 69504 54070 34833329
Cortisol decreased 39.97 10.56 26 69506 1101 34886298
Sputum increased 39.89 10.56 35 69497 2335 34885064
Obstructive airways disorder 39.46 10.56 92 69440 15402 34871997
Sleep apnoea syndrome 38.60 10.56 108 69424 20213 34867186
Hepatic function abnormal 38.59 10.56 20 69512 44343 34843056
Respiratory tract congestion 38.50 10.56 54 69478 6085 34881314
Renal failure 38.48 10.56 132 69400 130425 34756974
Cushing's syndrome 38.39 10.56 18 69514 395 34887004
Overdose 38.34 10.56 77 69455 90982 34796417
Ear infection 38.09 10.56 71 69461 10160 34877239
Foetal malformation 37.43 10.56 13 69519 125 34887274
Chest discomfort 36.62 10.56 209 69323 54321 34833078
Fatigue 35.75 10.56 977 68555 369676 34517723
Pancytopenia 35.51 10.56 86 69446 95071 34792328
Suffocation feeling 34.90 10.56 19 69513 577 34886822
Bronchospasm 34.50 10.56 70 69462 10661 34876738
Bronchial hyperreactivity 34.45 10.56 28 69504 1681 34885718
Gastrooesophageal reflux disease 34.30 10.56 158 69374 37766 34849633
Eye disorder 34.08 10.56 65 69467 9463 34877936
Rhabdomyolysis 33.80 10.56 52 69480 68111 34819288
Painful respiration 33.15 10.56 24 69508 1212 34886187
Chronic sinusitis 33.14 10.56 31 69501 2248 34885151
Antineutrophil cytoplasmic antibody positive 32.59 10.56 20 69512 764 34886635
Coma 32.36 10.56 26 69506 45652 34841747
Throat clearing 31.83 10.56 15 69517 333 34887066
Plethoric face 31.33 10.56 6 69526 0 34887399
Bone marrow failure 30.59 10.56 10 69522 29243 34858156
Blood immunoglobulin E increased 30.24 10.56 31 69501 2515 34884884
Nasopharyngitis 30.03 10.56 240 69292 69728 34817671
Chest injury 29.84 10.56 25 69507 1566 34885833
Metabolic acidosis 29.54 10.56 26 69506 43654 34843745
Bronchial obstruction 29.50 10.56 25 69507 1591 34885808
Secondary adrenocortical insufficiency 29.45 10.56 24 69508 1446 34885953
Leukopenia 29.24 10.56 50 69482 62806 34824593
Cytomegalovirus infection 29.03 10.56 8 69524 26127 34861272
Sinus congestion 28.95 10.56 45 69487 5560 34881839
Wrong technique in device usage process 28.86 10.56 24 69508 1488 34885911
Nasal inflammation 28.74 10.56 13 69519 262 34887137
Dysphonia 28.68 10.56 107 69425 23276 34864123
Drug resistance 28.68 10.56 8 69524 25919 34861480
Skin striae 28.66 10.56 17 69515 610 34886789
Pulmonary function test decreased 28.62 10.56 42 69490 4933 34882466
Hyperkalaemia 28.08 10.56 60 69472 69329 34818070
Dyspnoea exertional 27.83 10.56 164 69368 43115 34844284
Breath sounds abnormal 27.19 10.56 49 69483 6832 34880567
Stress 27.12 10.56 126 69406 30221 34857178
Injection site pruritus 26.67 10.56 49 69483 6934 34880465
Growth retardation 26.61 10.56 25 69507 1823 34885576
Foetal exposure during pregnancy 26.60 10.56 22 69510 38079 34849320
Eosinophil count increased 26.48 10.56 55 69477 8517 34878882
Headache 26.31 10.56 552 68980 200083 34687316
Status asthmaticus 26.29 10.56 13 69519 322 34887077
Mucosal inflammation 26.11 10.56 23 69509 38599 34848800
General physical health deterioration 26.08 10.56 149 69383 128120 34759279
Depressed level of consciousness 26.08 10.56 28 69504 42813 34844586
Septic shock 25.95 10.56 66 69466 71768 34815631
Walking aid user 25.75 10.56 25 69507 1899 34885500
Neuroleptic malignant syndrome 25.25 10.56 3 69529 17931 34869468
Febrile neutropenia 25.19 10.56 164 69368 136685 34750714
Throat irritation 24.96 10.56 61 69471 10524 34876875
Dyspnoea paroxysmal nocturnal 24.95 10.56 22 69510 1477 34885922
Treatment failure 24.74 10.56 34 69498 46663 34840736
Vision blurred 24.48 10.56 166 69366 45797 34841602
Lung hernia 24.33 10.56 8 69524 64 34887335
Blood creatinine increased 24.10 10.56 102 69430 94874 34792525
Tendon calcification 24.01 10.56 8 69524 67 34887332
Bradycardia 23.76 10.56 74 69458 75344 34812055
Tumour lysis syndrome 23.66 10.56 3 69529 17056 34870343
Cholestasis 23.65 10.56 12 69520 26936 34860463
Rhinitis 23.61 10.56 44 69488 6294 34881105
Drug interaction 23.33 10.56 313 69219 225633 34661766
Adrenal insufficiency 23.17 10.56 71 69461 13976 34873423
Drug reaction with eosinophilia and systemic symptoms 23.12 10.56 19 69513 32993 34854406
Lower respiratory tract infection 23.06 10.56 124 69408 31513 34855886
Rash maculo-papular 23.05 10.56 14 69518 28437 34858962
Hypertrophic osteoarthropathy 23.03 10.56 8 69524 77 34887322
Cerebral infarction 22.96 10.56 13 69519 27442 34859957
Juvenile idiopathic arthritis 22.35 10.56 23 69509 1874 34885525
Delirium 22.34 10.56 33 69499 43958 34843441
Sleep disorder 22.29 10.56 123 69409 31565 34855834
Hospitalisation 22.17 10.56 191 69341 56711 34830688
Loss of personal independence in daily activities 22.16 10.56 127 69405 33052 34854347
Multiple organ dysfunction syndrome 22.14 10.56 78 69454 76488 34810911
Seasonal allergy 22.00 10.56 44 69488 6631 34880768
Premature baby 21.82 10.56 6 69526 19627 34867772
Stridor 21.70 10.56 26 69506 2508 34884891
Injection site swelling 21.63 10.56 61 69471 11466 34875933
Sneezing 21.57 10.56 38 69494 5204 34882195
Middle insomnia 21.43 10.56 44 69488 6758 34880641
Central obesity 21.35 10.56 14 69518 601 34886798
Lacrimation increased 21.20 10.56 50 69482 8432 34878967
Carcinoid tumour of the gastrointestinal tract 20.76 10.56 7 69525 61 34887338
Eosinophilic oesophagitis 20.70 10.56 11 69521 318 34887081
Blood creatine phosphokinase increased 20.57 10.56 36 69496 44821 34842578
Serotonin syndrome 20.52 10.56 7 69525 19926 34867473
Forced expiratory flow decreased 20.43 10.56 9 69523 170 34887229
Altered state of consciousness 20.39 10.56 10 69522 22883 34864516
Snoring 20.34 10.56 29 69503 3317 34884082
Hypoacusis 20.33 10.56 75 69457 16226 34871173
Agranulocytosis 20.33 10.56 11 69521 23810 34863589
Cortisol abnormal 20.32 10.56 6 69526 32 34887367
Nasal obstruction 20.07 10.56 14 69518 666 34886733
Therapeutic product effect incomplete 19.87 10.56 170 69362 50371 34837028
Hypersomnia 19.80 10.56 62 69470 12345 34875054
Contraindicated product administered 19.72 10.56 9 69523 21472 34865927
Disease progression 19.64 10.56 130 69402 107947 34779452
Lipohypertrophy 19.50 10.56 10 69522 268 34887131
Anxiety 18.45 10.56 289 69243 99139 34788260
Hot flush 18.40 10.56 78 69454 17988 34869411
Drug intolerance 18.38 10.56 59 69473 59511 34827888
Nervous system neoplasm 18.21 10.56 8 69524 150 34887249
Oral candidiasis 17.95 10.56 59 69473 12051 34875348
Increased upper airway secretion 17.90 10.56 20 69512 1790 34885609
Cystic fibrosis respiratory infection suppression 17.73 10.56 9 69523 236 34887163
Blood lactate dehydrogenase increased 17.68 10.56 12 69520 22978 34864421
Oropharyngeal pain 17.62 10.56 126 69406 35359 34852040
Abnormal behaviour 17.61 10.56 97 69435 24872 34862527
Panic reaction 17.59 10.56 18 69514 1457 34885942
Impaired quality of life 17.58 10.56 37 69495 5781 34881618
Melaena 17.52 10.56 27 69505 35353 34852046
Atopy 17.49 10.56 9 69523 243 34887156
Hypomagnesaemia 17.36 10.56 11 69521 21840 34865559
Injection site urticaria 17.32 10.56 21 69511 2051 34885348
Toxic epidermal necrolysis 17.05 10.56 11 69521 21635 34865764
Nasal oedema 16.83 10.56 10 69522 360 34887039
Hepatotoxicity 16.81 10.56 11 69521 21474 34865925
Dry skin 16.66 10.56 113 69419 31174 34856225
Platelet count decreased 16.62 10.56 155 69377 119562 34767837
Hepatocellular injury 16.55 10.56 12 69520 22199 34865200
Rhinitis allergic 16.47 10.56 25 69507 3025 34884374
Anosmia 16.34 10.56 29 69503 3995 34883404
Trisomy 18 16.32 10.56 13 69519 758 34886641
Respiratory tract infection 16.27 10.56 80 69452 19632 34867767
Synovitis 16.20 10.56 4 69528 14062 34873337
Neutrophil count decreased 16.19 10.56 50 69482 51054 34836345
COVID-19 16.18 10.56 230 69302 77320 34810079
Cerebral haemorrhage 16.05 10.56 28 69504 34909 34852490
Anger 15.95 10.56 56 69476 11828 34875571
Infusion site erythema 15.77 10.56 21 69511 2252 34885147
Oesophageal candidiasis 15.73 10.56 30 69502 4366 34883033
Gastroenteritis viral 15.69 10.56 40 69492 7084 34880315
Increased viscosity of bronchial secretion 15.62 10.56 8 69524 214 34887185
Viral infection 15.62 10.56 73 69459 17550 34869849
Infusion site pruritus 15.58 10.56 13 69519 810 34886589
Eosinophilic bronchitis 15.55 10.56 8 69524 216 34887183
Rheumatoid arthritis 15.52 10.56 33 69499 38205 34849194
Urticaria 15.50 10.56 191 69341 62186 34825213
Respiratory syncytial virus infection 15.47 10.56 31 69501 4678 34882721
Cardiac failure 15.47 10.56 112 69420 91136 34796263
Choking 15.28 10.56 32 69500 4983 34882416
Pre-existing condition improved 15.08 10.56 22 69510 2570 34884829
Poisoning 15.04 10.56 3 69529 12223 34875176
Feeling cold 15.03 10.56 51 69481 10588 34876811
Injection site erythema 14.94 10.56 67 69465 15832 34871567
Peripheral swelling 14.78 10.56 224 69308 76317 34811082
Gamma-glutamyltransferase increased 14.77 10.56 22 69510 29209 34858190
Ear discomfort 14.76 10.56 22 69510 2620 34884779
Rhinalgia 14.69 10.56 14 69518 1039 34886360
Cardiac arrest 14.45 10.56 122 69410 96037 34791362
Nasal discomfort 14.43 10.56 17 69515 1611 34885788
Tracheal disorder 14.32 10.56 7 69525 169 34887230
Central nervous system mass 14.21 10.56 7 69525 172 34887227
Eye swelling 14.20 10.56 48 69484 9947 34877452
Extrapyramidal disorder 14.19 10.56 4 69528 12876 34874523
Wall motion score index abnormal 14.10 10.56 7 69525 175 34887224
Hyperbilirubinaemia 14.05 10.56 8 69524 16835 34870564
Poor quality device used 13.96 10.56 13 69519 937 34886462
Hypotension 13.96 10.56 335 69197 221314 34666085
Bronchiectasis 13.86 10.56 47 69485 9754 34877645
Transaminases increased 13.74 10.56 20 69512 26803 34860596
Nephropathy toxic 13.71 10.56 4 69528 12584 34874815
Nasal disorder 13.67 10.56 18 69514 1910 34885489
Personality change 13.62 10.56 31 69501 5108 34882291
Insulin autoimmune syndrome 13.46 10.56 8 69524 288 34887111
Shock 13.42 10.56 17 69515 24162 34863237
Hypertrichosis 13.37 10.56 9 69523 404 34886995
Blood urea increased 13.35 10.56 25 69507 30339 34857060
Drug-induced liver injury 13.34 10.56 23 69509 28809 34858590
Hypersensitivity 13.12 10.56 182 69350 60853 34826546
Viral myelitis 13.05 10.56 5 69527 65 34887334
Cardio-respiratory arrest 13.03 10.56 61 69471 55212 34832187
Acute hepatic failure 12.76 10.56 6 69526 14068 34873331
Kidney infection 12.62 10.56 31 69501 5363 34882036
Labelled drug-drug interaction medication error 12.60 10.56 7 69525 14932 34872467
Contusion 12.59 10.56 119 69413 36245 34851154
Neck pain 12.58 10.56 90 69442 25259 34862140
Inhalation therapy 12.51 10.56 4 69528 29 34887370
Smoke sensitivity 12.50 10.56 6 69526 139 34887260
Blood bilirubin increased 12.47 10.56 37 69495 38259 34849140
Hemiparesis 12.45 10.56 8 69524 15770 34871629
Respiratory disorder 12.38 10.56 73 69459 19191 34868208
Nightmare 12.30 10.56 59 69473 14332 34873067
Airway remodelling 12.30 10.56 7 69525 232 34887167
Back pain 12.22 10.56 323 69209 121466 34765933
Cytopenia 12.20 10.56 5 69527 12718 34874681
Skin fissures 12.07 10.56 30 69502 5229 34882170
Meralgia paraesthetica 11.94 10.56 6 69526 154 34887245
Pancreatic failure 11.88 10.56 11 69521 787 34886612
Haemoptysis 11.85 10.56 114 69418 34892 34852507
Haemoglobin decreased 11.83 10.56 169 69363 120603 34766796
Oxygen saturation decreased 11.78 10.56 161 69371 53657 34833742
Injection site bruising 11.78 10.56 41 69491 8622 34878777
Procedural pain 11.65 10.56 28 69504 4778 34882621
Hand-foot-and-mouth disease 11.57 10.56 5 69527 90 34887309
Proteinuria 11.55 10.56 12 69520 18630 34868769
Rhinovirus infection 11.47 10.56 26 69506 4273 34883126
Disseminated intravascular coagulation 11.44 10.56 16 69516 21800 34865599
Multiple allergies 11.38 10.56 21 69511 2982 34884417
Muscle spasms 11.36 10.56 211 69321 74790 34812609
Infusion site swelling 11.31 10.56 19 69513 2505 34884894
Night sweats 11.31 10.56 66 69466 17286 34870113
Nasal polypectomy 11.29 10.56 3 69529 10 34887389
Atelectasis 11.28 10.56 67 69465 17660 34869739
Haemophilus infection 11.24 10.56 13 69519 1208 34886191
Blood testosterone decreased 11.23 10.56 26 69506 4331 34883068
Constipation 11.19 10.56 354 69178 136628 34750771
Allergic sinusitis 11.18 10.56 5 69527 98 34887301
Sinus operation 11.15 10.56 10 69522 687 34886712
Idiopathic intracranial hypertension 11.10 10.56 10 69522 691 34886708
Penile erythema 11.09 10.56 6 69526 180 34887219
Migraine 11.08 10.56 66 69466 17412 34869987
Infusion site pain 11.07 10.56 24 69508 3827 34883572
Suicidal ideation 11.06 10.56 126 69406 40262 34847137
Alanine aminotransferase increased 11.05 10.56 105 69427 80710 34806689
Weight decreased 11.04 10.56 442 69090 175859 34711540
Ischaemic stroke 11.02 10.56 12 69520 18238 34869161
Increased bronchial secretion 10.99 10.56 16 69516 1865 34885534
Deformity thorax 10.96 10.56 4 69528 45 34887354
IPEX syndrome 10.86 10.56 3 69529 12 34887387
Cytokine release syndrome 10.82 10.56 18 69514 22859 34864540
Child abuse 10.79 10.56 8 69524 419 34886980
Hypoaesthesia 10.79 10.56 177 69355 61267 34826132
Hepatic failure 10.79 10.56 34 69498 34497 34852902
Otitis media 10.78 10.56 20 69512 2852 34884547
Sinus headache 10.76 10.56 12 69520 1072 34886327
Aplastic anaemia 10.74 10.56 3 69529 9713 34877686
Liver disorder 10.65 10.56 32 69500 32965 34854434
Acute respiratory failure 10.60 10.56 101 69431 30827 34856572

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 1106.48 9.68 1415 172060 133680 79437233
Toxicity to various agents 467.22 9.68 167 173308 421373 79149540
Completed suicide 427.77 9.68 27 173448 245740 79325173
Wheezing 394.06 9.68 818 172657 115846 79455067
Cough 387.66 9.68 1702 171773 365087 79205826
Infective pulmonary exacerbation of cystic fibrosis 384.11 9.68 276 173199 12575 79558338
Dyspnoea 332.33 9.68 3075 170400 853950 78716963
Eosinophilic granulomatosis with polyangiitis 278.02 9.68 143 173332 3517 79567396
Synovitis 257.94 9.68 18 173457 150716 79420197
Chest discomfort 248.47 9.68 762 172713 137282 79433631
Bronchitis 241.54 9.68 728 172747 129916 79440997
Sinusitis 225.24 9.68 932 172543 194569 79376344
Product dose omission issue 212.36 9.68 1082 172393 246455 79324458
Productive cough 195.15 9.68 525 172950 87806 79483107
Pemphigus 185.73 9.68 7 173468 99575 79471338
Hand deformity 178.97 9.68 12 173463 103907 79467006
Off label use 172.31 9.68 1212 172263 906003 78664910
Nasal congestion 170.11 9.68 456 173019 76096 79494817
Product quality issue 168.53 9.68 281 173194 33659 79537254
Contraindicated product administered 161.73 9.68 70 173405 157468 79413445
Acute kidney injury 160.67 9.68 585 172890 518819 79052094
Chronic obstructive pulmonary disease 160.65 9.68 479 172996 84940 79485973
Neutropenia 156.27 9.68 240 173235 287470 79283443
Obstructive airways disorder 154.25 9.68 259 173216 31200 79539713
Pneumonia 153.06 9.68 2145 171330 658101 78912812
Systemic lupus erythematosus 152.10 9.68 38 173437 121111 79449802
Upper respiratory tract infection 149.06 9.68 487 172988 90681 79480232
Drug abuse 146.46 9.68 86 173389 162605 79408308
Chronic sinusitis 145.35 9.68 160 173315 12866 79558047
Adrenal suppression 137.05 9.68 65 173410 1334 79569579
Sputum increased 133.11 9.68 97 173378 4516 79566397
General physical health deterioration 131.63 9.68 249 173226 274989 79295924
Pericarditis 130.26 9.68 33 173442 104203 79466710
Intentional overdose 127.77 9.68 36 173439 105924 79464989
Duodenal ulcer perforation 125.76 9.68 4 173471 66207 79504706
Thrombocytopenia 120.77 9.68 247 173228 265012 79305901
Nasal polyps 120.39 9.68 111 173364 7216 79563697
Drug intolerance 116.00 9.68 251 173224 263868 79307045
Treatment failure 114.53 9.68 121 173354 170365 79400548
Sleep apnoea syndrome 105.04 9.68 240 173235 36238 79534675
Helicobacter infection 104.33 9.68 14 173461 69690 79501223
Cystic fibrosis 103.90 9.68 78 173397 3802 79567111
Glossodynia 101.24 9.68 49 173426 103288 79467625
Wound 100.94 9.68 64 173411 116115 79454798
Therapeutic product effect decreased 100.63 9.68 125 173350 163738 79407175
Malignant neoplasm progression 100.05 9.68 89 173386 135901 79435012
Pancytopenia 96.07 9.68 132 173343 165613 79405300
Anxiety 95.15 9.68 891 172584 247621 79323292
Folliculitis 93.59 9.68 7 173468 55373 79515540
Muscle injury 91.99 9.68 3 173472 48558 79522355
Arthropathy 91.14 9.68 153 173322 176958 79393955
Full blood count abnormal 89.78 9.68 241 173234 40233 79530680
Sleep disorder due to a general medical condition 85.78 9.68 129 173346 14148 79556765
Forced expiratory volume decreased 85.49 9.68 95 173380 7719 79563194
Dermatitis atopic 84.75 9.68 107 173368 9949 79560964
Dyspnoea exertional 80.47 9.68 389 173086 86684 79484229
C-reactive protein increased 79.66 9.68 98 173377 128929 79441984
Febrile neutropenia 78.86 9.68 249 173226 230750 79340163
Dysphonia 78.30 9.68 287 173188 56585 79514328
Coma 77.54 9.68 63 173412 100586 79470327
Gastrooesophageal reflux disease 77.22 9.68 438 173037 103808 79467105
Sputum discoloured 76.31 9.68 155 173320 21588 79549325
Hepatic function abnormal 75.77 9.68 32 173443 73075 79497838
Hepatic enzyme increased 75.69 9.68 179 173296 182431 79388482
Product complaint 75.10 9.68 117 173358 13232 79557681
Mucosal inflammation 73.78 9.68 36 173439 75544 79495369
Influenza 73.78 9.68 509 172966 129097 79441816
Rhinorrhoea 72.57 9.68 343 173132 75731 79495182
Maternal exposure during pregnancy 71.12 9.68 117 173358 136421 79434492
Headache 70.58 9.68 1891 171584 651881 78919032
Leukopenia 70.35 9.68 90 173385 116423 79454490
Cushing's syndrome 70.20 9.68 37 173438 958 79569955
Bronchial neoplasm 70.15 9.68 30 173445 478 79570435
Procedural pain 69.95 9.68 155 173320 22929 79547984
Anaemia 69.07 9.68 627 172848 444388 79126525
Drug ineffective 68.87 9.68 1809 171666 1079104 78491809
Joint swelling 68.41 9.68 359 173116 288287 79282626
Female genital tract fistula 67.72 9.68 74 173401 5901 79565012
Renal impairment 67.53 9.68 152 173323 157631 79413282
Sleep disorder due to general medical condition, insomnia type 67.00 9.68 8 173467 43548 79527365
Alopecia 65.93 9.68 269 173206 231086 79339827
Metabolic acidosis 65.66 9.68 50 173425 82479 79488434
Drug interaction 63.97 9.68 586 172889 414597 79156316
Drug reaction with eosinophilia and systemic symptoms 63.63 9.68 30 173445 64214 79506699
Feeling abnormal 63.51 9.68 576 172899 158623 79412290
Liver injury 63.29 9.68 22 173453 56592 79514321
Overdose 63.25 9.68 198 173277 184008 79386905
Hepatotoxicity 62.73 9.68 17 173458 51335 79519578
Interstitial lung disease 61.95 9.68 93 173382 112507 79458406
Hypothalamic pituitary adrenal axis suppression 60.60 9.68 24 173451 311 79570602
Nasal turbinate hypertrophy 60.34 9.68 30 173445 685 79570228
Cardio-respiratory arrest 60.30 9.68 89 173386 108421 79462492
Stress 59.28 9.68 335 173140 79277 79491636
Pulmonary function test decreased 59.25 9.68 78 173397 7559 79563354
Chest pain 59.11 9.68 902 172573 281402 79289511
Respiratory symptom 58.99 9.68 62 173413 4729 79566184
Seasonal allergy 58.82 9.68 118 173357 16288 79554625
Bone marrow failure 58.64 9.68 19 173456 51088 79519825
Myelosuppression 58.19 9.68 9 173466 40287 79530626
Paraesthesia oral 58.17 9.68 134 173341 20337 79550576
Depressed level of consciousness 58.00 9.68 75 173400 96577 79474336
Migraine 56.70 9.68 355 173120 87138 79483775
Rhinitis 56.10 9.68 109 173366 14698 79556215
Salpingo-oophorectomy unilateral 55.98 9.68 30 173445 804 79570109
Multiple organ dysfunction syndrome 55.50 9.68 111 173364 120135 79450778
Illness 55.25 9.68 224 173251 46287 79524626
Oropharyngeal pain 55.04 9.68 417 173058 108936 79461977
Platelet count decreased 55.04 9.68 227 173248 194437 79376476
Endometrial ablation 54.06 9.68 30 173445 863 79570050
Viral infection 52.56 9.68 209 173266 42807 79528106
Oesophageal spasm 52.26 9.68 50 173425 3406 79567507
Eosinophil count increased 51.99 9.68 115 173360 16990 79553923
Rheumatoid arthritis 51.80 9.68 255 173220 208215 79362698
Bronchial obstruction 51.54 9.68 45 173430 2723 79568190
Sinusitis fungal 51.20 9.68 42 173433 2332 79568581
Ear infection 51.01 9.68 178 173297 34254 79536659
Cytomegalovirus infection 50.45 9.68 15 173460 42629 79528284
Hyperkalaemia 49.93 9.68 109 173366 114289 79456624
Impaired healing 49.58 9.68 71 173404 87584 79483329
Macular degeneration 48.85 9.68 88 173387 11208 79559705
Toxic epidermal necrolysis 47.03 9.68 19 173456 44562 79526351
Acute respiratory failure 46.63 9.68 254 173221 59287 79511626
Deep vein thrombosis 46.44 9.68 434 173041 120485 79450428
Gamma-glutamyltransferase increased 46.29 9.68 31 173444 54649 79516264
Sopor 46.27 9.68 8 173467 33002 79537911
Agranulocytosis 46.20 9.68 20 173455 45010 79525903
Eye pruritus 46.14 9.68 123 173352 20447 79550466
Cortisol decreased 45.95 9.68 38 173437 2134 79568779
Rhonchi 45.76 9.68 50 173425 3986 79566927
Bronchial haemorrhage 45.63 9.68 31 173444 1289 79569624
Epidural lipomatosis 45.23 9.68 30 173445 1198 79569715
Depression 44.71 9.68 691 172784 216099 79354814
Victim of child abuse 44.38 9.68 27 173448 926 79569987
Emotional distress 43.95 9.68 188 173287 39781 79531132
Food allergy 43.87 9.68 82 173393 10742 79560171
Intentional product use issue 43.86 9.68 176 173299 151936 79418977
Breath sounds abnormal 43.64 9.68 103 173372 15881 79555032
Cushingoid 43.34 9.68 76 173399 9476 79561437
Poisoning 43.26 9.68 3 173472 25269 79545644
Serotonin syndrome 43.11 9.68 22 173453 45005 79525908
Hepatocellular injury 43.03 9.68 25 173450 47568 79523345
Impaired quality of life 42.91 9.68 96 173379 14290 79556623
Rhabdomyolysis 42.79 9.68 101 173374 103030 79467883
Vision blurred 42.65 9.68 384 173091 105514 79465399
Altered state of consciousness 42.58 9.68 21 173454 43801 79527112
Emphysema 42.31 9.68 103 173372 16197 79554716
Poor quality device used 42.25 9.68 37 173438 2248 79568665
Blister 42.01 9.68 127 173348 119349 79451564
Adrenal insufficiency 41.97 9.68 147 173328 28340 79542573
Prolonged expiration 41.93 9.68 29 173446 1242 79569671
Confusional state 41.42 9.68 467 173008 317530 79253383
Hypotension 41.41 9.68 691 172784 439626 79131287
Infusion site erythema 41.29 9.68 74 173401 9386 79561527
Sinus disorder 41.28 9.68 125 173350 22339 79548574
Middle insomnia 41.13 9.68 101 173374 15968 79554945
Eczema 41.10 9.68 187 173288 40631 79530282
Cardiac failure 41.05 9.68 185 173290 154657 79416256
Cholestasis 40.90 9.68 32 173443 52077 79518836
Bradycardia 40.90 9.68 154 173321 135403 79435510
Bladder prolapse 40.79 9.68 30 173445 1417 79569496
Blood creatinine increased 40.66 9.68 186 173289 154871 79416042
Swelling 40.62 9.68 290 173185 216421 79354492
Upper-airway cough syndrome 40.61 9.68 83 173392 11610 79559303
Oesophageal pain 40.05 9.68 48 173427 4231 79566682
Status asthmaticus 39.89 9.68 26 173449 1008 79569905
COVID-19 39.88 9.68 521 172954 157153 79413760
Eosinophil count 39.70 9.68 14 173461 128 79570785
Hospitalisation 39.64 9.68 345 173130 93891 79477022
Blood immunoglobulin E increased 39.47 9.68 56 173419 5826 79565087
Cholecystitis chronic 38.85 9.68 74 173401 9832 79561081
Septic shock 38.70 9.68 137 173338 122664 79448249
Posterior reversible encephalopathy syndrome 37.65 9.68 6 173469 26275 79544638
Hiatus hernia 37.60 9.68 124 173351 23188 79547725
Pneumocystis jirovecii pneumonia 37.44 9.68 12 173463 32496 79538417
Embolism venous 37.15 9.68 46 173429 4193 79566720
Renal failure 37.14 9.68 270 173205 200698 79370215
Heart sounds 36.55 9.68 24 173451 942 79569971
Electrocardiogram QT prolonged 36.32 9.68 90 173385 90296 79480617
Rash maculo-papular 36.31 9.68 41 173434 56037 79514876
Oral candidiasis 36.23 9.68 144 173331 29484 79541429
Concussion 36.06 9.68 70 173405 9433 79561480
Acute sinusitis 35.96 9.68 47 173428 4523 79566390
Musculoskeletal stiffness 35.88 9.68 228 173247 174780 79396133
Discomfort 35.79 9.68 146 173329 125471 79445442
Bronchial disorder 35.74 9.68 35 173440 2454 79568459
Throat clearing 35.67 9.68 36 173439 2618 79568295
Drug resistance 35.64 9.68 24 173451 42189 79528724
Rhinitis allergic 35.62 9.68 81 173394 12188 79558725
Gastrointestinal disorder 35.47 9.68 141 173334 122064 79448849
Neutrophil count decreased 35.13 9.68 97 173378 93862 79477051
Urticaria 35.05 9.68 582 172893 184619 79386294
Nasal discomfort 35.03 9.68 51 173424 5432 79565481
Fluid retention 35.00 9.68 266 173209 69543 79501370
Mobility decreased 34.81 9.68 142 173333 122033 79448880
Drug-induced liver injury 34.09 9.68 57 173418 66060 79504853
Dermatitis allergic 33.43 9.68 101 173374 18029 79552884
Increased upper airway secretion 32.93 9.68 43 173432 4134 79566779
Extrapyramidal disorder 32.90 9.68 5 173470 22674 79548239
Palpitations 32.70 9.68 420 173055 126190 79444723
Foetal death 32.68 9.68 61 173414 7983 79562930
Suicide attempt 32.23 9.68 84 173391 82848 79488065
Infusion site pruritus 31.86 9.68 42 173433 4076 79566837
Pulmonary embolism 31.59 9.68 537 172938 171117 79399796
Disease progression 31.56 9.68 253 173222 184109 79386804
Neutropenic sepsis 31.15 9.68 10 173465 27054 79543859
Pulmonary mass 30.72 9.68 135 173340 28899 79542014
Diverticulum 30.35 9.68 86 173389 14810 79556103
Neuroleptic malignant syndrome 30.31 9.68 11 173464 27548 79543365
Throat irritation 30.28 9.68 172 173303 40774 79530139
Vocal cord dysfunction 30.13 9.68 18 173457 597 79570316
Infusion site swelling 30.13 9.68 58 173417 7768 79563145
Oxygen saturation decreased 29.99 9.68 420 173055 128627 79442286
Bronchospasm 29.74 9.68 120 173355 24739 79546174
Blood lactate dehydrogenase increased 29.56 9.68 25 173450 39145 79531768
Haemoptysis 29.56 9.68 216 173259 55783 79515130
Cardiac arrest 29.53 9.68 236 173239 171860 79399053
Chorioretinopathy 29.50 9.68 30 173445 2201 79568712
Urinary tract infection 29.48 9.68 794 172681 273718 79297195
Tinnitus 29.41 9.68 181 173294 44152 79526761
Vaginal flatulence 29.37 9.68 32 173443 2543 79568370
Respiratory tract infection 28.75 9.68 193 173282 48496 79522417
Pulmonary hypertension 28.63 9.68 191 173284 47889 79523024
Weight decreased 28.42 9.68 991 172484 354207 79216706
Pruritus 28.41 9.68 1088 172387 393560 79177353
Eosinophilic bronchitis 28.35 9.68 16 173459 476 79570437
Bronchial hyperreactivity 28.28 9.68 34 173441 3006 79567907
Sinus operation 28.14 9.68 31 173444 2494 79568419
Toxic skin eruption 27.95 9.68 7 173468 22286 79548627
Diastolic dysfunction 27.72 9.68 68 173407 10743 79560170
Delirium 27.61 9.68 93 173382 84534 79486379
Neck pain 27.61 9.68 268 173207 75149 79495764
Ear discomfort 27.56 9.68 59 173416 8524 79562389
Fatigue 27.36 9.68 2362 171113 927365 78643548
Growth retardation 27.30 9.68 27 173448 1916 79568997
Sinus congestion 27.04 9.68 100 173375 19796 79551117
Respiratory tract congestion 26.87 9.68 100 173375 19854 79551059
Jaundice 26.59 9.68 47 173428 53302 79517611
Irritable bowel syndrome 26.58 9.68 60 173415 62181 79508732
Dry skin 26.57 9.68 245 173230 67750 79503163
Therapy non-responder 26.47 9.68 107 173368 92198 79478715
Anosmia 26.36 9.68 59 173416 8785 79562128
Alanine aminotransferase increased 26.06 9.68 227 173248 162343 79408570
Therapeutic product effect incomplete 26.01 9.68 443 173032 141202 79429711
Vaginal discharge 25.95 9.68 53 173422 7410 79563503
Shock 25.90 9.68 34 173441 43514 79527399
Burning sensation 25.89 9.68 217 173258 58415 79512498
Aplastic anaemia 25.85 9.68 4 173471 17901 79553012
Infusion related reaction 25.85 9.68 349 173126 229888 79341025
Dizziness 25.83 9.68 1396 172079 525045 79045868
Oesophagogastroduodenoscopy 25.81 9.68 12 173463 235 79570678
Central obesity 25.73 9.68 25 173450 1736 79569177
Malaise 25.64 9.68 1307 172168 488562 79082351
Hypoxia 25.61 9.68 340 173135 102903 79468010
Tumour lysis syndrome 25.58 9.68 10 173465 23929 79546984
Swelling face 25.55 9.68 252 173223 70960 79499953
Cor pulmonale 25.55 9.68 28 173447 2240 79568673
Respiratory disorder 25.41 9.68 176 173299 44680 79526233
Hypervolaemia 25.07 9.68 169 173306 42521 79528392
Hypokalaemia 24.96 9.68 197 173278 143843 79427070
Rheumatoid nodule 24.94 9.68 4 173471 17434 79553479
Therapy partial responder 24.86 9.68 4 173471 17393 79553520
Rectal prolapse 24.73 9.68 27 173448 2151 79568762
Candida infection 24.71 9.68 155 173320 38059 79532854
Iron deficiency anaemia 24.65 9.68 116 173359 25556 79545357
Aphonia 24.49 9.68 63 173412 10249 79560664
Nephropathy toxic 24.49 9.68 7 173468 20412 79550501
Oropharyngeal oedema 24.34 9.68 14 173461 432 79570481
Labelled drug-drug interaction medication error 24.32 9.68 15 173460 27635 79543278
Death 24.23 9.68 997 172478 565517 79005396
Respiratory arrest 24.16 9.68 56 173419 57494 79513419
Lactic acidosis 23.87 9.68 76 173399 70283 79500630
Haemophilus infection 23.75 9.68 27 173448 2249 79568664
Secondary adrenocortical insufficiency 23.72 9.68 31 173444 2983 79567930
Inflammation 23.66 9.68 114 173361 93639 79477274
Nasal mucosal disorder 23.65 9.68 13 173462 367 79570546
Cerebral haemorrhage 23.51 9.68 57 173418 57616 79513297
Hip arthroplasty 23.30 9.68 26 173449 35730 79535183
Injury 23.02 9.68 264 173211 77232 79493681
Cerebral infarction 22.98 9.68 40 173435 45636 79525277
Biliary dyskinesia 22.92 9.68 28 173447 2517 79568396
Bronchiectasis 22.86 9.68 103 173372 22283 79548630
Palmar-plantar erythrodysaesthesia syndrome 22.81 9.68 23 173452 33111 79537802
Feeling cold 22.79 9.68 123 173352 28606 79542307
Sneezing 22.74 9.68 94 173381 19589 79551324
Nasal inflammation 22.61 9.68 16 173459 711 79570202
Suffocation feeling 22.51 9.68 23 173452 1697 79569216
Skin striae 22.48 9.68 24 173451 1864 79569049
Eosinophilic pneumonia chronic 22.40 9.68 14 173461 504 79570409
Growth failure 22.37 9.68 11 173464 245 79570668
Hereditary angioedema 22.35 9.68 41 173434 5294 79565619
Thrombotic microangiopathy 22.26 9.68 8 173467 20161 79550752
Ectropion 22.20 9.68 13 173462 415 79570498
Chest injury 22.18 9.68 29 173446 2792 79568121
Granuloma 22.14 9.68 53 173422 8244 79562669
Anuria 22.00 9.68 9 173466 20954 79549959
Cystic fibrosis respiratory infection suppression 21.76 9.68 13 173462 431 79570482
Drug eruption 21.63 9.68 39 173436 43896 79527017
Gastroenteritis viral 21.55 9.68 109 173366 24722 79546191
Disease recurrence 21.51 9.68 167 173308 43942 79526971
Blood bilirubin increased 21.46 9.68 73 173402 66159 79504754
Live birth 21.44 9.68 7 173468 18737 79552176
Insomnia 21.37 9.68 691 172784 244479 79326434
Blood creatine phosphokinase increased 21.31 9.68 73 173402 66017 79504896
Lymphopenia 21.28 9.68 21 173454 30536 79540377
Infusion site extravasation 21.23 9.68 59 173416 10049 79560864
Ankle fracture 21.17 9.68 83 173392 16886 79554027
Hysterectomy 21.17 9.68 44 173431 6228 79564685
Throat tightness 21.14 9.68 118 173357 27789 79543124
Cytopenia 20.99 9.68 9 173466 20374 79550539
Airway remodelling 20.93 9.68 11 173464 283 79570630
Acute respiratory distress syndrome 20.91 9.68 40 173435 44027 79526886
Inhalation therapy 20.89 9.68 7 173468 54 79570859
Hepatic failure 20.85 9.68 66 173409 61146 79509767
Cystic fibrosis related diabetes 20.62 9.68 10 173465 216 79570697
Drug level increased 20.61 9.68 34 173441 39617 79531296
Acute generalised exanthematous pustulosis 20.54 9.68 6 173469 17248 79553665
Blood corticotrophin 20.53 9.68 4 173471 0 79570913
Cytokine release syndrome 20.51 9.68 29 173446 35969 79534944
Melaena 20.50 9.68 66 173409 60824 79510089
Hypothermia 20.49 9.68 12 173463 22734 79548179
Graft versus host disease 20.29 9.68 4 173471 15022 79555891
Cystitis 20.10 9.68 189 173286 52543 79518370
Lung hernia 20.05 9.68 7 173468 62 79570851
Multiple allergies 19.97 9.68 59 173416 10401 79560512
Antineutrophil cytoplasmic antibody positive 19.95 9.68 19 173456 1287 79569626
Infusion site pain 19.89 9.68 72 173403 14104 79556809
Croup infectious 19.80 9.68 15 173460 741 79570172
Eye disorder 19.78 9.68 102 173373 23310 79547603
Gluten sensitivity 19.74 9.68 12 173463 411 79570502
Tubulointerstitial nephritis 19.68 9.68 33 173442 38202 79532711
Ear canal erythema 19.57 9.68 5 173470 12 79570901
Acute myeloid leukaemia 19.54 9.68 23 173452 30862 79540051
Dyspnoea paroxysmal nocturnal 19.24 9.68 24 173451 2204 79568709
Nodular vasculitis 19.20 9.68 6 173469 36 79570877
Hypertrophic osteoarthropathy 19.14 9.68 8 173467 120 79570793
Peak expiratory flow rate decreased 18.89 9.68 14 173461 669 79570244
Tricuspid valve incompetence 18.88 9.68 89 173386 19623 79551290
Proteinuria 18.70 9.68 26 173449 32476 79538437
Ischaemic stroke 18.57 9.68 27 173448 33104 79537809
Hyperthermia 18.52 9.68 8 173467 18029 79552884
Inappropriate antidiuretic hormone secretion 18.42 9.68 18 173457 26295 79544618
Arthropod bite 18.34 9.68 50 173425 8421 79562492
Back pain 18.31 9.68 823 172652 303357 79267556
Forced expiratory flow decreased 18.30 9.68 10 173465 279 79570634
Osteoporosis 18.22 9.68 189 173286 53923 79516990
Expiratory reserve volume decreased 18.01 9.68 7 173468 86 79570827
Metastases to bone 17.94 9.68 16 173459 24411 79546502
Carcinoid tumour of the gastrointestinal tract 17.94 9.68 7 173468 87 79570826
Affective disorder 17.91 9.68 49 173426 8270 79562643
Fracture displacement 17.82 9.68 18 173457 1310 79569603
Bronchitis bacterial 17.72 9.68 19 173456 1483 79569430
Torsade de pointes 17.66 9.68 10 173465 19302 79551611
Tendon calcification 17.62 9.68 8 173467 148 79570765
Shock haemorrhagic 17.48 9.68 11 173464 20049 79550864
Bone erosion 17.40 9.68 81 173394 17766 79553147
Osteonecrosis of jaw 17.40 9.68 43 173432 43183 79527730
Stevens-Johnson syndrome 17.35 9.68 37 173438 39129 79531784
Pharyngitis streptococcal 17.29 9.68 57 173418 10657 79560256
Abnormal behaviour 17.27 9.68 137 173338 36284 79534629
Circulatory collapse 17.18 9.68 35 173440 37633 79533280
Mite allergy 17.11 9.68 17 173458 1213 79569700
Coeliac disease 17.09 9.68 59 173416 11292 79559621
Pulmonary arterial hypertension 17.08 9.68 113 173362 28253 79542660
Diabetic ketoacidosis 17.06 9.68 30 173445 34092 79536821
Epilepsy 16.95 9.68 40 173435 40820 79530093
Stridor 16.95 9.68 37 173438 5416 79565497
Limb injury 16.80 9.68 116 173359 29412 79541501
Infusion site mass 16.80 9.68 19 173456 1574 79569339
Cardiac septal defect 16.73 9.68 10 173465 332 79570581
Lymphoedema 16.54 9.68 62 173413 12351 79558562
Heart rate increased 16.51 9.68 361 173114 120363 79450550
Transplant rejection 16.47 9.68 11 173464 19426 79551487
Sinus headache 16.40 9.68 35 173440 5045 79565868
Aspartate aminotransferase increased 16.34 9.68 208 173267 138433 79432480
Rhinovirus infection 16.29 9.68 46 173429 7907 79563006
Laryngeal pain 16.26 9.68 39 173436 6075 79564838
Radiculopathy 16.12 9.68 49 173426 8775 79562138
Plethoric face 16.00 9.68 5 173470 30 79570883
Injection site inflammation 15.96 9.68 30 173445 3946 79566967
Hyperbilirubinaemia 15.79 9.68 18 173457 24500 79546413
Brain oedema 15.78 9.68 19 173456 25244 79545669
Respiratory syncytial virus bronchiolitis 15.74 9.68 11 173464 479 79570434
Psoriasis 15.65 9.68 278 173197 89309 79481604
Injection site bruising 15.65 9.68 147 173328 40855 79530058
Sedation 15.62 9.68 59 173416 51836 79519077
Eosinophil count abnormal 15.60 9.68 13 173462 738 79570175
Surgery 15.39 9.68 123 173352 32643 79538270
Muscle spasms 15.35 9.68 493 172982 174237 79396676
Pre-existing condition improved 15.35 9.68 36 173439 5527 79565386
Cortisol abnormal 15.34 9.68 6 173469 75 79570838
Painful respiration 15.06 9.68 27 173448 3426 79567487
Gastrointestinal procedural complication 15.04 9.68 8 173467 211 79570702
Vitamin D decreased 15.03 9.68 51 173424 9674 79561239
Vulva cyst 15.01 9.68 4 173471 12 79570901
Hypomagnesaemia 15.00 9.68 52 173423 46859 79524054
Disseminated intravascular coagulation 14.94 9.68 35 173440 35807 79535106
Respiration abnormal 14.94 9.68 44 173431 7744 79563169
Hypercalcaemia 14.87 9.68 39 173436 38391 79532522
Pneumococcal infection 14.75 9.68 14 173461 944 79569969
Haemoglobin decreased 14.74 9.68 369 173106 221750 79349163
Insurance issue 14.64 9.68 36 173439 5697 79565216
Dermatitis contact 14.61 9.68 55 173420 10978 79559935
FEV1/FVC ratio decreased 14.61 9.68 8 173467 224 79570689
Myalgia 14.59 9.68 517 172958 185124 79385789
Psychotic disorder 14.55 9.68 44 173431 41358 79529555
Stomatitis 14.52 9.68 228 173247 146529 79424384
Pharyngeal erythema 14.47 9.68 20 173455 2030 79568883
Hypertransaminasaemia 14.46 9.68 4 173471 11920 79558993
Lupus-like syndrome 14.46 9.68 6 173469 13851 79557062
Hepatitis cholestatic 14.45 9.68 6 173469 13846 79557067
Electrocardiogram QRS complex prolonged 14.38 9.68 3 173472 10830 79560083
Cytomegalovirus viraemia 14.30 9.68 5 173470 12816 79558097
Lemierre syndrome 14.28 9.68 7 173468 155 79570758
Snoring 14.26 9.68 35 173440 5531 79565382
Dyspepsia 14.23 9.68 323 173152 108364 79462549
Temperature intolerance 14.22 9.68 50 173425 9655 79561258
Hyponatraemia 14.20 9.68 287 173188 177561 79393352
Transaminases increased 14.20 9.68 61 173414 51682 79519231
Increased viscosity of bronchial secretion 14.18 9.68 11 173464 563 79570350
Periarthritis 14.09 9.68 24 173451 2924 79567989
Anger 13.97 9.68 74 173401 17088 79553825
Eye swelling 13.91 9.68 102 173373 26366 79544547
Pemphigoid 13.91 9.68 8 173467 15307 79555606
Mood altered 13.88 9.68 76 173399 17771 79553142
Eosinophilic oesophagitis 13.85 9.68 11 173464 583 79570330
Nightmare 13.79 9.68 100 173375 25761 79545152
Bronchoscopy 13.78 9.68 6 173469 100 79570813
Cystitis interstitial 13.75 9.68 16 173459 1367 79569546
Acute hepatic failure 13.71 9.68 28 173447 30085 79540828
Chronic respiratory failure 13.65 9.68 24 173451 2998 79567915
Weight increased 13.65 9.68 736 172739 276650 79294263
Infusion site haemorrhage 13.63 9.68 27 173448 3693 79567220
Wall motion score index abnormal 13.50 9.68 7 173468 175 79570738
Smoke sensitivity 13.50 9.68 11 173464 605 79570308
Decreased appetite 13.48 9.68 608 172867 341810 79229103
Central nervous system mass 13.47 9.68 7 173468 176 79570737
Injection site pruritus 13.44 9.68 146 173329 42137 79528776
Neurotoxicity 13.36 9.68 32 173443 32486 79538427
Respiratory tract irritation 13.36 9.68 11 173464 614 79570299
Musculoskeletal chest pain 13.34 9.68 96 173379 24668 79546245
Pneumonia aspiration 13.33 9.68 88 173387 66879 79504034
Anaphylactic reaction 13.29 9.68 256 173219 83487 79487426
Chills 13.28 9.68 449 173026 159785 79411128
Encephalopathy 13.20 9.68 89 173386 67308 79503605
Temperature regulation disorder 13.13 9.68 35 173440 5818 79565095
Blood urea increased 13.10 9.68 58 173417 48732 79522181
Sepsis 13.06 9.68 467 173008 268961 79301952
Irritability 13.05 9.68 142 173333 41002 79529911
Proctitis 12.97 9.68 37 173438 6395 79564518
Blood cholesterol increased 12.92 9.68 118 173357 83602 79487311
Myocarditis 12.89 9.68 17 173458 21716 79549197
Enuresis 12.80 9.68 24 173451 3152 79567761
Hypersomnia 12.73 9.68 90 173385 22996 79547917
Red blood cell sedimentation rate increased 12.71 9.68 54 173421 45888 79525025
Panic reaction 12.67 9.68 30 173445 4635 79566278
Educational problem 12.62 9.68 9 173466 405 79570508
Tooth infection 12.56 9.68 77 173398 18755 79552158
Breast cancer stage III 12.49 9.68 3 173472 9823 79561090
Intentional self-injury 12.47 9.68 33 173442 32386 79538527
Haematuria 12.46 9.68 93 173382 68743 79502170
Staphylococcal infection 12.45 9.68 187 173288 58108 79512805
Glucocorticoids increased 12.44 9.68 6 173469 128 79570785
Dystonia 12.43 9.68 17 173458 21382 79549531
Cellulitis 12.42 9.68 318 173157 108742 79462171
Ill-defined disorder 12.40 9.68 88 173387 65787 79505126
Thermal burn 12.37 9.68 39 173436 7121 79563792
Muscle rigidity 12.37 9.68 15 173460 19867 79551046
Upper limb fracture 12.32 9.68 74 173401 17893 79553020
Premature delivery 12.31 9.68 20 173455 23447 79547466
Otorrhoea 12.28 9.68 17 173458 1728 79569185
Lymphocyte count decreased 12.22 9.68 57 173418 47232 79523681
Skin swelling 12.21 9.68 27 173448 3987 79566926
Foot deformity 12.18 9.68 21 173454 24053 79546860
Wrong technique in device usage process 12.15 9.68 27 173448 4001 79566912
Atopy 12.13 9.68 9 173466 431 79570482
Vena cava embolism 12.12 9.68 3 173472 6 79570907
Hot flush 12.10 9.68 177 173298 54700 79516213
Infusion site discomfort 12.07 9.68 15 173460 1372 79569541
Restlessness 12.04 9.68 56 173419 46436 79524477
Parkinsonism 12.01 9.68 11 173464 16573 79554340
Lip swelling 11.98 9.68 139 173336 40772 79530141
Dry eye 11.97 9.68 128 173347 36803 79534110
Sinonasal obstruction 11.96 9.68 8 173467 324 79570589
Akathisia 11.93 9.68 7 173468 13252 79557661
Panniculitis 11.91 9.68 6 173469 12365 79558548
Lipohypertrophy 11.90 9.68 12 173463 872 79570041
Purpura 11.87 9.68 15 173460 19512 79551401
Expired product administered 11.81 9.68 38 173437 7013 79563900
Fracture pain 11.80 9.68 11 173464 725 79570188
Product substitution issue 11.78 9.68 80 173395 20176 79550737
Nocturnal dyspnoea 11.69 9.68 16 173459 1610 79569303
Rales 11.63 9.68 79 173396 19922 79550991
Injection site urticaria 11.62 9.68 57 173418 12769 79558144
Abdominal discomfort 11.61 9.68 437 173038 250290 79320623
Haemolytic anaemia 11.56 9.68 13 173462 17807 79553106
Febrile bone marrow aplasia 11.54 9.68 7 173468 13013 79557900
Penile erythema 11.50 9.68 6 173469 152 79570761
Hilar lymphadenopathy 11.46 9.68 17 173458 1842 79569071
Essential hypertension 11.42 9.68 34 173441 6019 79564894
Kidney transplant rejection 11.42 9.68 4 173471 10242 79560671
Nephrotic syndrome 11.40 9.68 5 173470 11169 79559744
Skin ulcer 11.37 9.68 70 173405 54080 79516833
Nasal septum deviation 11.36 9.68 17 173458 1856 79569057
Cataplexy 11.34 9.68 12 173463 922 79569991
Progressive multifocal leukoencephalopathy 11.34 9.68 17 173458 20583 79550330
Tic 11.33 9.68 22 173453 2964 79567949
Arthritis bacterial 11.26 9.68 3 173472 9163 79561750
Joint range of motion decreased 11.25 9.68 36 173439 33246 79537667
Pain 11.20 9.68 1719 171756 702083 78868830
Peritonitis 11.20 9.68 28 173447 28008 79542905
Cholangitis 11.14 9.68 7 173468 12769 79558144
Epstein-Barr virus infection 11.13 9.68 9 173466 14407 79556506
Secretion discharge 11.04 9.68 63 173412 14959 79555954
Selective IgA immunodeficiency 11.02 9.68 3 173472 10 79570903
Exercise tolerance decreased 11.02 9.68 44 173431 9027 79561886
Nasopharyngitis 11.01 9.68 666 172809 253215 79317698
Pathogen resistance 11.01 9.68 9 173466 14333 79556580
Blood pressure inadequately controlled 11.00 9.68 34 173441 6143 79564770
Metastases to lung 10.99 9.68 14 173461 18149 79552764
Femoral neck fracture 10.95 9.68 4 173471 9980 79560933
Hyperuricaemia 10.95 9.68 6 173469 11793 79559120
Drug ineffective for unapproved indication 10.88 9.68 66 173409 51172 79519741
Skin necrosis 10.88 9.68 14 173461 18073 79552840
Cholecystectomy 10.86 9.68 45 173430 9387 79561526
Increased bronchial secretion 10.83 9.68 23 173452 3304 79567609
Miosis 10.82 9.68 11 173464 15778 79555135
Asphyxia 10.82 9.68 6 173469 11714 79559199
Device breakage 10.81 9.68 49 173426 10626 79560287
Loss of personal independence in daily activities 10.79 9.68 296 173179 102284 79468629
Pain in extremity 10.78 9.68 927 172548 363611 79207302
Senile osteoporosis 10.70 9.68 5 173470 99 79570814
IPEX syndrome 10.60 9.68 3 173472 12 79570901
Pituitary-dependent Cushing's syndrome 10.60 9.68 3 173472 12 79570901
Orthostatic hypotension 10.59 9.68 75 173400 56089 79514824
Polyneuropathy 10.54 9.68 23 173452 24128 79546785
Asthmatic crisis 10.48 9.68 17 173458 1989 79568924
Iliotibial band syndrome 10.45 9.68 4 173471 47 79570866
COVID-19 immunisation 10.41 9.68 14 173461 1385 79569528
Adenoidal hypertrophy 10.41 9.68 6 173469 186 79570727
Panic attack 10.36 9.68 89 173386 24127 79546786
Paranasal sinus discomfort 10.35 9.68 27 173448 4429 79566484
Otitis media 10.32 9.68 33 173442 6073 79564840
Schizophrenia 10.31 9.68 11 173464 15429 79555484
Ileus paralytic 10.31 9.68 4 173471 9616 79561297
Infusion site bruising 10.30 9.68 21 173454 2931 79567982
Colorectal cancer 10.30 9.68 3 173472 8644 79562269
Gallbladder injury 10.30 9.68 13 173462 1208 79569705
Atypical fracture 10.27 9.68 10 173465 696 79570217
Umbilical hernia 10.25 9.68 32 173443 5813 79565100
Ligament sprain 10.24 9.68 57 173418 13407 79557506
Product taste abnormal 10.21 9.68 18 173457 2253 79568660
Wolff-Parkinson-White syndrome 10.20 9.68 7 173468 296 79570617
Neuroendocrine tumour of the lung metastatic 10.18 9.68 5 173470 111 79570802
Fracture 10.16 9.68 20 173455 21781 79549132
Facet joint syndrome 10.13 9.68 6 173469 11296 79559617
Child abuse 10.12 9.68 8 173467 421 79570492
Carpal tunnel syndrome 10.12 9.68 75 173400 19453 79551460
Nasal discharge discolouration 10.09 9.68 19 173456 2502 79568411
Insulin autoimmune syndrome 10.07 9.68 8 173467 424 79570489
Upper gastrointestinal haemorrhage 10.05 9.68 51 173424 41329 79529584
Cerumen impaction 10.04 9.68 13 173462 1239 79569674
Stress fracture 10.03 9.68 34 173441 6446 79564467
Rash erythematous 10.00 9.68 179 173296 57590 79513323
Vocal cord atrophy 9.90 9.68 3 173472 16 79570897
Adrenocortical insufficiency acute 9.86 9.68 21 173454 3022 79567891
Gallbladder disorder 9.86 9.68 74 173401 19266 79551647
Autoimmune disorder 9.85 9.68 13 173462 16599 79554314
Viral myelitis 9.83 9.68 5 173470 120 79570793
Hypertrichosis 9.80 9.68 13 173462 1269 79569644
Hyperhidrosis 9.79 9.68 413 173062 151079 79419834
Sputum retention 9.77 9.68 12 173463 1085 79569828
Pulmonary congestion 9.77 9.68 96 173379 27004 79543909
Neoplasm progression 9.75 9.68 69 173406 51613 79519300
Thyroid atrophy 9.74 9.68 3 173472 17 79570896
Ulcer 9.73 9.68 33 173442 29939 79540974
Transplant evaluation 9.72 9.68 15 173460 1682 79569231
Uterine perforation 9.70 9.68 33 173442 6270 79564643

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D07AC17 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, potent (group III)
ATC R01AD08 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R01AD58 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R03AK06 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK11 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03BA05 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Glucocorticoids
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists
FDA EPC N0000175576 Corticosteroid
CHEBI has role CHEBI:49167 anti-asthmatic drugs
CHEBI has role CHEBI:50857 anti-allergic drugs
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D001993 Bronchodilator Agents
MeSH PA D003879 Dermatologic Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D019141 Respiratory System Agents
CHEBI has role CHEBI:35472 anti-inflammatory drugs
CHEBI has role CHEBI:35523 bronchodilator
CHEBI has role CHEBI:37962 adrenergic agents
CHEBI has role CHEBI:50177 dermatologic agent

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

DiseaseRelationSNOMED_IDDOID
Atopic dermatitis indication 24079001 DOID:3310
Contact dermatitis indication 40275004 DOID:2773
Seborrheic dermatitis indication 50563003 DOID:8741
Lichen simplex chronicus indication 53891004
Allergic rhinitis indication 61582004
Granuloma annulare indication 65508009 DOID:3777
Pulmonary emphysema indication 87433001
Pruritus ani indication 90446007
Discoid lupus erythematosus indication 200938002
Plaque psoriasis indication 200965009
Scalp psoriasis indication 238608008
Non-allergic asthma indication 266361008 DOID:9360
Pruritus of genital organs indication 267802000
Eruption of skin indication 271807003 DOID:0050486
Allergic asthma indication 389145006 DOID:9415
Primary cutaneous T-cell lymphoma indication 400122007
Asthma management indication 406162001
Chronic Non-Allergic Rhinitis indication
Bronchospasm Prevention with COPD indication
COPD Associated with Chronic Bronchitis indication
Severe chronic obstructive pulmonary disease off-label use 313299006
Mycosis contraindication 3218000 DOID:1564
Ocular hypertension contraindication 4210003 DOID:9282
Inactive tuberculosis contraindication 11999007
Epistaxis contraindication 12441001
Measles contraindication 14189004 DOID:8622
Disease caused by parasite contraindication 17322007
Glaucoma contraindication 23986001 DOID:1686
Acute tuberculosis contraindication 25629007
Viral disease contraindication 34014006 DOID:934
Hypertensive disorder contraindication 38341003 DOID:10763
Hypokalemia contraindication 43339004
Conduction disorder of the heart contraindication 44808001
Hypercortisolism contraindication 47270006
Ketoacidosis contraindication 56051008
Osteoporosis contraindication 64859006 DOID:11476
Diabetes mellitus contraindication 73211009 DOID:9351
Hypopituitarism contraindication 74728003 DOID:9406
Candidiasis of mouth contraindication 79740000 DOID:14262
Perforation of nasal septum contraindication 80142000
Hyperglycemia contraindication 80394007 DOID:4195
Bacterial infectious disease contraindication 87628006
Operation on nose contraindication 88733004
Thyrotoxicosis contraindication 90739004 DOID:7997
Bilateral cataracts contraindication 95722004
Prolonged QT interval contraindication 111975006
Seizure disorder contraindication 128613002
Pulmonary tuberculosis contraindication 154283005 DOID:2957
Ophthalmic herpes simplex contraindication 186542001
Disease of liver contraindication 235856003 DOID:409
Telangiectasia disorder contraindication 247479008
Exacerbation of asthma contraindication 281239006
Varicella-zoster virus infection contraindication 309465005
Osteopenia contraindication 312894000
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Atrophoderma contraindication 399979006
Peripheral vascular disease contraindication 400047006
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Congenital long QT syndrome contraindication 442917000
Exposure to varicella contraindication 444453009
Untreated Fungal Infection contraindication
Nasal Septal Ulcers contraindication
Uncontrolled Bacterial Infections contraindication
Nasal Candidiasis contraindication
Nasal Trauma contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.49 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.137MG/SPRAY;0.05MG/SPRAY DYMISTA MYLAN SPECIALITY LP N202236 May 1, 2012 RX SPRAY, METERED NASAL 9259428 June 13, 2023 TREATMENT OF SEASONAL ALLERGIC RHINITIS
0.137MG/SPRAY;0.05MG/SPRAY DYMISTA MYLAN SPECIALITY LP N202236 May 1, 2012 RX SPRAY, METERED NASAL 8163723 Aug. 29, 2023 ALLERGIC RHINITIS
0.137MG/SPRAY;0.05MG/SPRAY DYMISTA MYLAN SPECIALITY LP N202236 May 1, 2012 RX SPRAY, METERED NASAL 8163723 Aug. 29, 2023 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS
0.137MG/SPRAY;0.05MG/SPRAY DYMISTA MYLAN SPECIALITY LP N202236 May 1, 2012 RX SPRAY, METERED NASAL 8163723 Aug. 29, 2023 TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL ALLERGIC RHINITIS
0.137MG/SPRAY;0.05MG/SPRAY DYMISTA MYLAN SPECIALITY LP N202236 May 1, 2012 RX SPRAY, METERED NASAL 8163723 Aug. 29, 2023 TREATMENT OF SEASONAL ALLERGIC RHINITIS
0.137MG/SPRAY;0.05MG/SPRAY DYMISTA MYLAN SPECIALITY LP N202236 May 1, 2012 RX SPRAY, METERED NASAL 8163723 Aug. 29, 2023 TREATMENT OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
0.093MG XHANCE OPTINOSE US INC N209022 Sept. 18, 2017 RX SPRAY, METERED NASAL 8327844 Oct. 24, 2023 METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY
0.093MG XHANCE OPTINOSE US INC N209022 Sept. 18, 2017 RX SPRAY, METERED NASAL 7975690 Dec. 29, 2025 METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY
0.093MG XHANCE OPTINOSE US INC N209022 Sept. 18, 2017 RX SPRAY, METERED NASAL 10124132 March 6, 2027 METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY
0.093MG XHANCE OPTINOSE US INC N209022 Sept. 18, 2017 RX SPRAY, METERED NASAL 11602603 Oct. 27, 2028 METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY
0.093MG XHANCE OPTINOSE US INC N209022 Sept. 18, 2017 RX SPRAY, METERED NASAL 10076615 July 30, 2029 METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY
0.093MG XHANCE OPTINOSE US INC N209022 Sept. 18, 2017 RX SPRAY, METERED NASAL 10179216 July 8, 2033 METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY
0.093MG XHANCE OPTINOSE US INC N209022 Sept. 18, 2017 RX SPRAY, METERED NASAL 10478574 Nov. 4, 2033 METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO DIGIHALER TEVA PHARM N208799 July 12, 2019 RX POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO RESPICLICK TEVA PHARM N208799 Jan. 27, 2017 RX POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO DIGIHALER TEVA PHARM N208799 July 12, 2019 RX POWDER INHALATION 9415008 Oct. 6, 2034 TREATMENT OF ASTHMA
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO RESPICLICK TEVA PHARM N208799 Jan. 27, 2017 RX POWDER INHALATION 9415008 Oct. 6, 2034 TREATMENT OF ASTHMA
0.113MG/INH;EQ 0.014MG BASE/INH AIRDUO DIGIHALER TEVA PHARM N208799 July 12, 2019 RX POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.113MG/INH;EQ 0.014MG BASE/INH AIRDUO RESPICLICK TEVA PHARM N208799 Jan. 27, 2017 RX POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.232MG/INH;EQ 0.014MG BASE/INH AIRDUO DIGIHALER TEVA PHARM N208799 July 12, 2019 RX POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.232MG/INH;EQ 0.014MG BASE/INH AIRDUO RESPICLICK TEVA PHARM N208799 Jan. 27, 2017 RX POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.093MG XHANCE OPTINOSE US INC N209022 Sept. 18, 2017 RX SPRAY, METERED NASAL 10300229 July 7, 2035 METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY
0.093MG XHANCE OPTINOSE US INC N209022 Sept. 18, 2017 RX SPRAY, METERED NASAL 11554229 Feb. 23, 2036 METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.03MG/INH ARMONAIR RESPICLICK TEVA PHARM N208798 July 9, 2021 DISCN POWDER INHALATION July 9, 2024 NEW STRENGTH
0.055MG/INH ARMONAIR DIGIHALER TEVA PHARM N208798 Feb. 20, 2020 RX POWDER INHALATION July 9, 2024 NEW PATIENT POPULATION
0.055MG/INH ARMONAIR RESPICLICK TEVA PHARM N208798 Jan. 27, 2017 DISCN POWDER INHALATION July 9, 2024 NEW PATIENT POPULATION
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO DIGIHALER TEVA PHARM N208799 July 12, 2019 RX POWDER INHALATION July 9, 2024 REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO RESPICLICK TEVA PHARM N208799 Jan. 27, 2017 RX POWDER INHALATION July 9, 2024 REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
0.03MG/INH ARMONAIR RESPICLICK TEVA PHARM N208798 July 9, 2021 DISCN POWDER INHALATION Jan. 9, 2025 PEDIATRIC EXCLUSIVITY
0.055MG/INH ARMONAIR DIGIHALER TEVA PHARM N208798 Feb. 20, 2020 RX POWDER INHALATION Jan. 9, 2025 PEDIATRIC EXCLUSIVITY
0.055MG/INH ARMONAIR RESPICLICK TEVA PHARM N208798 Jan. 27, 2017 DISCN POWDER INHALATION Jan. 9, 2025 PEDIATRIC EXCLUSIVITY
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO DIGIHALER TEVA PHARM N208799 July 12, 2019 RX POWDER INHALATION Jan. 9, 2025 PEDIATRIC EXCLUSIVITY
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO RESPICLICK TEVA PHARM N208799 Jan. 27, 2017 RX POWDER INHALATION Jan. 9, 2025 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST EC50 10.74 WOMBAT-PK CHEMBL
Mineralocorticoid receptor Nuclear hormone receptor AGONIST EC50 6.83 IUPHAR
Progesterone receptor Nuclear hormone receptor AGONIST EC50 9.77 WOMBAT-PK
Cytosolic phospholipase A2 Enzyme WOMBAT-PK
Glucocorticoid receptor Transcription factor EC50 9.12 CHEMBL

External reference:

IDSource
4020180 VUID
N0000148122 NUI
D01708 KEGG_DRUG
4020180 VANDF
4020529 VANDF
C0117996 UMLSCUI
CHEBI:31441 CHEBI
CHEBI:5134 CHEBI
CHEMBL1473 ChEMBL_ID
D000068298 MESH_DESCRIPTOR_UI
DB00588 DRUGBANK_ID
7080 IUPHAR_LIGAND_ID
O2GMZ0LF5W UNII
444036 PUBCHEM_CID
DB13867 DRUGBANK_ID
41126 RXNORM
4756 MMSL
51966 MMSL
81052 MMSL
d01296 MMSL
003593 NDDF
004952 NDDF
108632003 SNOMEDCT_US
396064000 SNOMEDCT_US
397192001 SNOMEDCT_US
C0082607 UMLSCUI
CHEMBL1201396 ChEMBL_ID
5636 INN_ID
90566-53-3 SECONDARY_CAS_RN
5311101 PUBCHEM_CID
6699 IUPHAR_LIGAND_ID
CUT2W21N7U UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DYMISTA HUMAN PRESCRIPTION DRUG LABEL 2 0037-0245 SPRAY, METERED 50 ug NASAL NDA 29 sections
DYMISTA HUMAN PRESCRIPTION DRUG LABEL 2 0037-0245 SPRAY, METERED 50 ug NASAL NDA 29 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0054-0326 POWDER 100 ug RESPIRATORY (INHALATION) ANDA 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0054-0326 POWDER 100 ug RESPIRATORY (INHALATION) ANDA 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0054-0327 POWDER 250 ug RESPIRATORY (INHALATION) ANDA 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0054-0327 POWDER 250 ug RESPIRATORY (INHALATION) ANDA 28 sections
Fluticasone Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0054-3270 SPRAY, METERED 50 ug NASAL ANDA 26 sections
Fluticasone Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0054-3270 SPRAY, METERED 50 ug NASAL ANDA 26 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3607 POWDER, METERED 55 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3607 POWDER, METERED 55 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3607 POWDER, METERED 55 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3608 POWDER, METERED 113 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3608 POWDER, METERED 113 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3608 POWDER, METERED 113 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3609 POWDER, METERED 232 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3609 POWDER, METERED 232 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3609 POWDER, METERED 232 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-7516 POWDER 500 ug RESPIRATORY (INHALATION) ANDA 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-7516 POWDER 500 ug RESPIRATORY (INHALATION) ANDA 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-7517 POWDER 100 ug RESPIRATORY (INHALATION) ANDA 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-7517 POWDER 100 ug RESPIRATORY (INHALATION) ANDA 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-7518 POWDER 250 ug RESPIRATORY (INHALATION) ANDA 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-7518 POWDER 250 ug RESPIRATORY (INHALATION) ANDA 28 sections
Good Sense 24 hour allergy nasal HUMAN OTC DRUG LABEL 1 0113-0028 SPRAY, METERED 50 ug NASAL ANDA 17 sections
Good Sense 24 hour allergy nasal HUMAN OTC DRUG LABEL 1 0113-0028 SPRAY, METERED 50 ug NASAL ANDA 17 sections
Good Sense 24 hour allergy nasal HUMAN OTC DRUG LABEL 1 0113-0285 SPRAY, METERED 50 ug NASAL ANDA 17 sections
Good Sense 24 hour allergy nasal HUMAN OTC DRUG LABEL 1 0113-0285 SPRAY, METERED 50 ug NASAL ANDA 17 sections
basic care allergy relief nasal HUMAN OTC DRUG LABEL 1 0113-7117 SPRAY, METERED 50 ug NASAL ANDA 17 sections
FLONASEALLERGY RELIEF HUMAN OTC DRUG LABEL 1 0135-0576 SPRAY, METERED 50 ug NASAL NDA 16 sections
FLONASEALLERGY RELIEF HUMAN OTC DRUG LABEL 1 0135-0576 SPRAY, METERED 50 ug NASAL NDA 16 sections