fluticasone propionate ๐Ÿถ 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) 2 Benet LZ, Broccatelli F, Oprea TI
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 ยตM/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 757.81 9.70 1044 130852 88293 50384935
Wheezing 351.73 9.70 602 131294 61445 50411783
Completed suicide 309.93 9.70 7 131889 131882 50341346
Contraindicated product administered 279.37 9.70 31 131865 148927 50324301
Infective pulmonary exacerbation of cystic fibrosis 261.66 9.70 194 131702 7715 50465513
Toxicity to various agents 257.24 9.70 116 131780 212383 50260845
Cough 251.69 9.70 1268 130628 239996 50233232
Synovitis 250.37 9.70 19 131877 123846 50349382
Dyspnoea 241.35 9.70 2328 129568 545280 49927948
Systemic lupus erythematosus 221.32 9.70 48 131848 140574 50332654
Hand deformity 218.77 9.70 10 131886 100189 50373039
Sinusitis 202.66 9.70 931 130965 169627 50303601
Chest discomfort 202.58 9.70 616 131280 92106 50381122
Bronchitis 188.66 9.70 649 131247 103510 50369718
Glossodynia 176.73 9.70 42 131854 115527 50357701
Chronic obstructive pulmonary disease 170.08 9.70 408 131488 53027 50420201
Treatment failure 157.49 9.70 81 131815 137556 50335672
Drug intolerance 156.56 9.70 205 131691 218899 50254329
Product quality issue 151.11 9.70 281 131615 30577 50442651
Pericarditis 151.00 9.70 15 131881 78674 50394554
Eosinophilic granulomatosis with polyangiitis 148.17 9.70 81 131815 1874 50471354
Off label use 140.49 9.70 698 131198 473728 49999500
Joint swelling 139.71 9.70 267 131629 245019 50228209
Wound 138.86 9.70 51 131845 105743 50367485
Arthropathy 134.37 9.70 128 131768 157778 50315450
Maternal exposure during pregnancy 126.32 9.70 138 131758 159640 50313588
Alopecia 125.81 9.70 283 131613 244764 50228464
Therapeutic product effect decreased 122.05 9.70 105 131791 135945 50337283
Obstructive airways disorder 119.25 9.70 174 131722 15478 50457750
Pneumonia 119.20 9.70 1507 130389 376894 50096334
Drug ineffective 114.12 9.70 1481 130415 817852 49655376
Hepatic enzyme increased 113.82 9.70 114 131782 137266 50335962
Neutropenia 110.24 9.70 134 131762 147831 50325397
Product dose omission issue 107.85 9.70 834 131062 183004 50290224
General physical health deterioration 106.10 9.70 129 131767 142305 50330923
Nasal congestion 101.77 9.70 329 131567 50791 50422437
Drug abuse 101.37 9.70 17 131879 59829 50413399
Intentional overdose 98.96 9.70 21 131875 62483 50410745
Sleep apnoea syndrome 98.19 9.70 202 131694 23666 50449562
Anxiety 95.57 9.70 790 131106 176816 50296412
Helicobacter infection 86.71 9.70 13 131883 49689 50423539
Sputum increased 85.69 9.70 56 131840 1811 50471417
Upper respiratory tract infection 85.09 9.70 369 131527 65529 50407699
Productive cough 83.95 9.70 315 131581 52379 50420849
Muscle injury 83.34 9.70 3 131893 37108 50436120
Rheumatoid arthritis 83.34 9.70 261 131635 202289 50270939
Chronic sinusitis 81.40 9.70 90 131806 6055 50467173
Folliculitis 79.26 9.70 6 131890 39219 50434009
Nasal polyps 78.59 9.70 60 131836 2494 50470734
Febrile neutropenia 77.54 9.70 84 131812 97583 50375645
Macular degeneration 76.75 9.70 136 131760 14252 50458976
Discomfort 76.70 9.70 102 131794 108278 50364950
Thrombocytopenia 76.12 9.70 135 131761 127538 50345690
Infusion related reaction 73.67 9.70 213 131683 169344 50303884
Dysphonia 70.90 9.70 243 131653 38649 50434579
Adrenal suppression 68.50 9.70 37 131859 835 50472393
Sleep disorder due to a general medical condition 66.68 9.70 89 131807 7282 50465946
Swelling 65.45 9.70 285 131611 200587 50272641
Sleep disorder due to general medical condition, insomnia type 63.00 9.70 5 131891 31442 50441786
Gastrooesophageal reflux disease 62.82 9.70 377 131519 76051 50397177
Acute kidney injury 59.80 9.70 349 131547 227709 50245519
Leukopenia 58.26 9.70 54 131842 67474 50405754
Malignant neoplasm progression 58.16 9.70 55 131841 68069 50405159
Product complaint 58.11 9.70 106 131790 11360 50461868
Pancytopenia 56.53 9.70 82 131814 83948 50389280
Rhinitis allergic 56.24 9.70 81 131815 7119 50466109
Dyspnoea exertional 54.41 9.70 271 131625 50962 50422266
Bronchial neoplasm 53.58 9.70 25 131871 408 50472820
Abdominal discomfort 53.28 9.70 369 131527 231272 50241956
Bronchial haemorrhage 52.16 9.70 26 131870 494 50472734
Emotional distress 50.42 9.70 177 131719 28486 50444742
Feeling abnormal 50.18 9.70 524 131372 124968 50348260
Respiratory symptom 49.83 9.70 45 131851 2369 50470859
Coma 49.64 9.70 45 131851 56834 50416394
Drug interaction 49.42 9.70 311 131585 199310 50273918
Pulmonary function test decreased 49.04 9.70 52 131844 3336 50469892
Nasal turbinate hypertrophy 48.68 9.70 27 131869 643 50472585
Mucosal inflammation 48.35 9.70 22 131874 40120 50433108
Migraine 48.29 9.70 349 131547 74931 50398297
Hepatotoxicity 47.76 9.70 7 131889 27219 50446009
Seasonal allergy 47.68 9.70 113 131783 14563 50458665
Chest pain 47.06 9.70 684 131212 176198 50297030
Cystic fibrosis 46.95 9.70 47 131849 2817 50470411
Emphysema 46.00 9.70 84 131812 9009 50464219
Blister 45.94 9.70 96 131800 85322 50387906
Forced expiratory volume decreased 45.94 9.70 57 131839 4337 50468891
Rhonchi 45.66 9.70 42 131854 2265 50470963
Salpingo-oophorectomy unilateral 45.44 9.70 24 131872 517 50472711
Rhinorrhoea 45.32 9.70 259 131637 51324 50421904
Full blood count abnormal 45.16 9.70 149 131747 23239 50449989
Hepatic function abnormal 44.15 9.70 15 131881 32666 50440562
Drug reaction with eosinophilia and systemic symptoms 44.07 9.70 10 131886 28414 50444814
Impaired healing 43.21 9.70 72 131824 69714 50403514
Sinusitis fungal 43.11 9.70 32 131864 1274 50471954
Depression 42.94 9.70 637 131259 164786 50308442
Gamma-glutamyltransferase increased 42.89 9.70 12 131884 29611 50443617
Sinus disorder 42.49 9.70 125 131771 18333 50454895
Bronchial disorder 42.29 9.70 30 131866 1112 50472116
Multiple organ dysfunction syndrome 41.39 9.70 42 131854 50295 50422933
Nasal discomfort 41.39 9.70 51 131845 3853 50469375
Cushing's syndrome 41.39 9.70 24 131872 624 50472604
Sputum discoloured 41.22 9.70 101 131795 13294 50459934
Headache 41.07 9.70 1661 130235 504874 49968354
Oropharyngeal pain 40.67 9.70 344 131552 77457 50395771
Injury 40.61 9.70 242 131654 48683 50424545
Diverticulum 40.36 9.70 87 131809 10527 50462701
Bone erosion 40.17 9.70 92 131804 11595 50461633
Cholecystitis chronic 39.96 9.70 82 131814 9587 50463641
Cardio-respiratory arrest 39.89 9.70 49 131847 53843 50419385
Endometrial ablation 39.89 9.70 26 131870 837 50472391
Rhinitis 39.88 9.70 75 131821 8226 50465002
Musculoskeletal stiffness 39.59 9.70 186 131710 128295 50344933
Overdose 39.23 9.70 131 131765 99596 50373632
Deep vein thrombosis 38.25 9.70 324 131572 72980 50400248
Acute respiratory failure 37.77 9.70 162 131734 28620 50444608
Dizziness 37.47 9.70 1174 130722 345195 50128033
Adrenal insufficiency 37.23 9.70 101 131795 14142 50459086
Dermatitis allergic 37.13 9.70 94 131802 12626 50460602
Upper-airway cough syndrome 37.11 9.70 74 131822 8476 50464752
Ear infection 37.07 9.70 150 131746 25820 50447408
Embolism venous 36.98 9.70 39 131857 2486 50470742
Prolonged expiration 36.49 9.70 23 131873 698 50472530
Multiple allergies 36.43 9.70 73 131823 8390 50464838
Bone marrow failure 35.09 9.70 14 131882 27610 50445618
Viral infection 35.00 9.70 163 131733 29823 50443405
Influenza 34.90 9.70 372 131524 89166 50384062
Metabolic acidosis 34.74 9.70 30 131866 38795 50434433
Increased upper airway secretion 33.21 9.70 41 131855 3103 50470125
Ectropion 32.37 9.70 13 131883 144 50473084
Drug hypersensitivity 32.35 9.70 460 131436 250550 50222678
C-reactive protein increased 32.25 9.70 79 131817 66395 50406833
Product use issue 31.97 9.70 243 131653 149232 50323996
Platelet count decreased 31.51 9.70 145 131751 100581 50372647
Pre-existing condition improved 31.49 9.70 62 131834 7035 50466193
Anaemia 31.36 9.70 466 131430 251990 50221238
Toxic epidermal necrolysis 31.34 9.70 8 131888 20984 50452244
Candida infection 31.33 9.70 133 131763 23390 50449838
Palpitations 31.13 9.70 380 131516 94126 50379102
Pulmonary embolism 30.97 9.70 403 131493 101301 50371927
Acute sinusitis 30.70 9.70 42 131854 3518 50469710
Death 30.69 9.70 631 131265 324748 50148480
Dermatitis atopic 30.46 9.70 42 131854 3544 50469684
Bladder prolapse 30.06 9.70 30 131866 1791 50471437
Infusion site swelling 29.82 9.70 61 131835 7115 50466113
Liver injury 29.24 9.70 14 131882 24792 50448436
Infusion site erythema 29.22 9.70 68 131828 8659 50464569
Eczema 29.19 9.70 127 131769 22575 50450653
Cholestasis 28.94 9.70 15 131881 25386 50447842
Hiatus hernia 28.65 9.70 109 131787 18235 50454993
Agranulocytosis 28.64 9.70 10 131886 21411 50451817
Hepatocellular injury 28.58 9.70 16 131880 25931 50447297
Foetal exposure during pregnancy 28.54 9.70 18 131878 27341 50445887
Bronchial obstruction 28.52 9.70 25 131871 1265 50471963
Concussion 28.40 9.70 62 131834 7566 50465662
Pulmonary mass 28.28 9.70 110 131786 18595 50454633
Diastolic dysfunction 28.12 9.70 50 131846 5252 50467976
Throat irritation 27.99 9.70 154 131742 30085 50443143
Gastrointestinal disorder 27.78 9.70 139 131757 94317 50378911
Anosmia 27.50 9.70 42 131854 3889 50469339
Renal impairment 26.69 9.70 104 131792 75557 50397671
Status asthmaticus 26.58 9.70 20 131876 813 50472415
Eosinophil count increased 26.56 9.70 66 131830 8764 50464464
Cytomegalovirus infection 26.52 9.70 7 131889 17955 50455273
Nasal mucosal disorder 26.47 9.70 15 131881 373 50472855
Breath sounds abnormal 26.40 9.70 61 131835 7731 50465497
Suicide attempt 26.27 9.70 60 131836 51672 50421556
Oropharyngeal oedema 26.27 9.70 13 131883 243 50472985
Poor quality device used 26.07 9.70 28 131868 1823 50471405
Posterior reversible encephalopathy syndrome 25.81 9.70 4 131892 14924 50458304
Depressed level of consciousness 25.79 9.70 61 131835 51892 50421336
Hyponatraemia 25.22 9.70 147 131749 95992 50377236
Pneumocystis jirovecii pneumonia 25.19 9.70 4 131892 14659 50458569
Urinary tract infection 25.15 9.70 763 131133 223257 50249971
Serotonin syndrome 24.78 9.70 17 131879 24696 50448532
Neutrophil count decreased 24.51 9.70 52 131844 45974 50427254
Heart sounds 24.38 9.70 17 131879 613 50472615
Oesophageal spasm 24.35 9.70 30 131866 2266 50470962
Burning sensation 24.30 9.70 202 131694 45244 50427984
Rash 24.29 9.70 914 130982 436557 50036671
Electrocardiogram QT prolonged 24.13 9.70 63 131833 51823 50421405
Rectal prolapse 23.83 9.70 26 131870 1723 50471505
Premature baby 23.77 9.70 9 131887 18328 50454900
Tricuspid valve incompetence 23.45 9.70 80 131816 12690 50460538
Oesophagogastroduodenoscopy 22.97 9.70 9 131887 93 50473135
Irritable bowel syndrome 22.76 9.70 64 131832 51377 50421851
Exposure during pregnancy 22.56 9.70 204 131692 120811 50352417
Pruritus 22.45 9.70 928 130968 282640 50190588
Expiratory reserve volume decreased 22.38 9.70 7 131889 34 50473194
Granuloma 22.24 9.70 43 131853 4815 50468413
Interstitial lung disease 22.20 9.70 68 131828 53108 50420120
Throat clearing 22.15 9.70 21 131875 1177 50472051
Bronchitis bacterial 22.07 9.70 17 131879 716 50472512
Illness 22.06 9.70 124 131772 24416 50448812
Therapeutic response unexpected 21.98 9.70 91 131805 15824 50457404
Hypotension 21.77 9.70 458 131438 235011 50238217
Croup infectious 21.75 9.70 14 131882 441 50472787
Inhalation therapy 21.59 9.70 7 131889 39 50473189
Eosinophilic pneumonia chronic 21.33 9.70 10 131886 165 50473063
Infusion site nodule 21.30 9.70 20 131876 1107 50472121
Bradycardia 21.19 9.70 91 131805 64335 50408893
Oesophageal pain 21.12 9.70 31 131865 2771 50470457
Bronchial wall thickening 20.94 9.70 18 131878 887 50472341
Haemoptysis 20.90 9.70 126 131770 25447 50447781
Infusion site haemorrhage 20.88 9.70 32 131864 2972 50470256
Altered state of consciousness 20.76 9.70 16 131880 21894 50451334
Peak expiratory flow rate decreased 20.75 9.70 15 131881 573 50472655
Rheumatoid nodule 20.73 9.70 4 131892 12731 50460497
Cor pulmonale 20.57 9.70 25 131871 1862 50471366
Myelosuppression 20.47 9.70 5 131891 13512 50459716
Biliary dyskinesia 20.37 9.70 29 131867 2521 50470707
Respiratory tract infection 20.27 9.70 148 131748 31869 50441359
Confusional state 20.14 9.70 352 131544 185576 50287652
Female genital tract fistula 20.00 9.70 35 131861 3631 50469597
Neutropenic sepsis 19.98 9.70 6 131890 14141 50459087
Circulatory collapse 19.73 9.70 14 131882 19986 50453242
Lymphopenia 19.70 9.70 8 131888 15613 50457615
Toxic skin eruption 19.49 9.70 3 131893 11248 50461980
Respiratory arrest 19.48 9.70 30 131866 29979 50443249
Eosinophil count abnormal 19.21 9.70 13 131883 446 50472782
Pulmonary hypertension 19.20 9.70 151 131745 33266 50439962
Aphonia 19.12 9.70 57 131839 8421 50464807
Blood immunoglobulin E increased 19.10 9.70 27 131869 2332 50470896
Drug eruption 19.06 9.70 20 131876 23586 50449642
Bronchospasm 19.02 9.70 83 131813 14771 50458457
Hyperkalaemia 19.02 9.70 63 131833 48026 50425202
Muscle spasms 18.77 9.70 444 131452 125109 50348119
Hospitalisation 18.54 9.70 264 131632 67673 50405555
Stress 18.45 9.70 218 131678 53575 50419653
Hip arthroplasty 18.27 9.70 32 131864 30397 50442831
Premature delivery 18.06 9.70 21 131875 23642 50449586
Affective disorder 18.04 9.70 41 131855 5140 50468088
Mobility decreased 18.02 9.70 128 131768 79820 50393408
Cystic fibrosis related diabetes 17.99 9.70 6 131890 37 50473191
Growth failure 17.90 9.70 11 131885 319 50472909
Neurotoxicity 17.87 9.70 8 131888 14732 50458496
Iron deficiency anaemia 17.83 9.70 89 131807 16745 50456483
Oxygen saturation decreased 17.79 9.70 279 131617 72969 50400259
Hysterectomy 17.75 9.70 53 131843 7837 50465391
Sinus operation 17.73 9.70 22 131874 1674 50471554
Bronchiectasis 17.65 9.70 63 131833 10220 50463008
Blood lactate dehydrogenase increased 17.64 9.70 15 131881 19547 50453681
Influenza like illness 17.61 9.70 228 131668 57231 50415997
Eye pruritus 17.57 9.70 72 131824 12462 50460766
Jaundice 17.56 9.70 26 131870 26403 50446825
Gallbladder disorder 17.37 9.70 88 131808 16654 50456574
Cortisol decreased 17.29 9.70 17 131879 997 50472231
Ankle fracture 17.28 9.70 84 131812 15638 50457590
Urticaria 17.23 9.70 451 131445 129110 50344118
Metastases to bone 17.23 9.70 13 131883 17982 50455246
Tinnitus 17.21 9.70 129 131767 28003 50445225
Thyroid atrophy 17.18 9.70 5 131891 18 50473210
Nodular vasculitis 17.18 9.70 5 131891 18 50473210
Intentional self-injury 17.12 9.70 21 131875 23091 50450137
Fracture displacement 17.02 9.70 18 131878 1151 50472077
Infusion site pruritus 17.00 9.70 34 131862 3903 50469325
Total lung capacity abnormal 16.99 9.70 6 131890 45 50473183
Cardiac arrest 16.94 9.70 138 131758 83513 50389715
Live birth 16.83 9.70 11 131885 16397 50456831
Sinus headache 16.70 9.70 37 131859 4561 50468667
Blood creatinine increased 16.65 9.70 123 131773 76037 50397191
Infusion site pain 16.59 9.70 70 131826 12276 50460952
Hypoxia 16.58 9.70 205 131691 50918 50422310
Surgery 16.54 9.70 135 131761 30070 50443158
Hypokalaemia 16.54 9.70 148 131748 87844 50385384
Disease progression 16.42 9.70 165 131731 95701 50377527
Exposure to SARS-CoV-2 16.15 9.70 13 131883 584 50472644
Shock 16.11 9.70 18 131878 20632 50452596
Intentional product use issue 15.98 9.70 126 131770 76792 50396436
Hepatic failure 15.94 9.70 38 131858 32245 50440983
Weight decreased 15.70 9.70 716 131180 220529 50252699
Pneumococcal infection 15.67 9.70 11 131885 401 50472827
Hereditary angioedema 15.66 9.70 40 131856 5402 50467826
FEV1/FVC ratio decreased 15.57 9.70 6 131890 59 50473169
Fluid retention 15.53 9.70 201 131695 50448 50422780
Gallbladder injury 15.52 9.70 18 131878 1276 50471952
Anuria 15.47 9.70 5 131891 11239 50461989
Swelling face 15.41 9.70 207 131689 52388 50420840
Hypothermia 15.41 9.70 6 131890 12010 50461218
Asthmatic crisis 15.25 9.70 20 131876 1608 50471620
Palmar-plantar erythrodysaesthesia syndrome 15.16 9.70 18 131878 20080 50453148
Cardiac failure 15.14 9.70 126 131770 75914 50397314
Haemophilus infection 15.11 9.70 16 131880 1025 50472203
Hypervolaemia 15.08 9.70 116 131780 25383 50447845
Sinus congestion 14.89 9.70 74 131822 13897 50459331
Infusion site extravasation 14.88 9.70 46 131850 6930 50466298
Ear canal erythema 14.86 9.70 3 131893 0 50473228
Stevens-Johnson syndrome 14.84 9.70 21 131875 21731 50451497
Limb injury 14.82 9.70 97 131799 20153 50453075
Growth retardation 14.64 9.70 16 131880 1062 50472166
Gammopathy 14.44 9.70 7 131889 125 50473103
Cholecystectomy 14.30 9.70 55 131841 9248 50463980
Bronchospasm paradoxical 14.29 9.70 6 131890 75 50473153
Respiratory tract congestion 14.29 9.70 74 131822 14125 50459103
Injection site inflammation 14.22 9.70 28 131868 3177 50470051
Acute generalised exanthematous pustulosis 14.15 9.70 3 131893 8935 50464293
Eosinophilic bronchitis 14.10 9.70 11 131885 472 50472756
Conjunctivitis allergic 14.07 9.70 13 131883 705 50472523
Peripheral swelling 14.03 9.70 419 131477 205517 50267711
Sneezing 14.00 9.70 73 131823 13971 50459257
Multiple drug therapy 13.98 9.70 21 131875 1916 50471312
Infusion site bruising 13.96 9.70 23 131873 2272 50470956
Middle insomnia 13.92 9.70 57 131839 9864 50463364
Arthralgia 13.82 9.70 971 130925 437731 50035497
Gluten sensitivity 13.77 9.70 11 131885 489 50472739
Senile osteoporosis 13.73 9.70 8 131888 210 50473018
Transplant rejection 13.71 9.70 4 131892 9605 50463623
Aspirin-exacerbated respiratory disease 13.70 9.70 14 131882 860 50472368
Lactic acidosis 13.67 9.70 43 131853 33312 50439916
Dystonia 13.65 9.70 7 131889 11919 50461309
Anaphylactic reaction 13.55 9.70 207 131689 53848 50419380
Mite allergy 13.52 9.70 11 131885 502 50472726
Oedema peripheral 13.42 9.70 521 131375 157440 50315788
Hepatitis 13.35 9.70 133 131763 31320 50441908
Thermal burn 13.33 9.70 35 131861 4806 50468422
Osteoporosis 13.30 9.70 177 131719 44702 50428526
Drug resistance 13.29 9.70 18 131878 18971 50454257
Laryngeal pain 13.28 9.70 32 131864 4167 50469061
Vision blurred 13.28 9.70 283 131613 78364 50394864
Lemierre syndrome 13.25 9.70 6 131890 91 50473137
Inappropriate antidiuretic hormone secretion 13.23 9.70 9 131887 13134 50460094
Bronchial irritation 13.22 9.70 4 131892 17 50473211
Memory impairment 13.22 9.70 285 131611 79075 50394153
Exercise tolerance decreased 13.18 9.70 35 131861 4839 50468389
Abortion spontaneous 13.13 9.70 60 131836 41712 50431516
Acute myeloid leukaemia 13.06 9.70 12 131884 15062 50458166
Ear discomfort 13.05 9.70 43 131853 6701 50466527
Throat tightness 12.98 9.70 96 131800 20751 50452477
Transferrin saturation decreased 12.94 9.70 11 131885 534 50472694
Road traffic accident 12.89 9.70 108 131788 24244 50448984
Insomnia 12.86 9.70 568 131328 174297 50298931
Respiratory disorder 12.81 9.70 131 131765 31056 50442172
Anhedonia 12.80 9.70 54 131842 9470 50463758
Cardiovascular deconditioning 12.79 9.70 3 131893 3 50473225
Fracture 12.78 9.70 15 131881 16818 50456410
Wolff-Parkinson-White syndrome 12.69 9.70 6 131890 101 50473127
Epilepsy 12.66 9.70 23 131873 21544 50451684
Septic shock 12.66 9.70 92 131804 57083 50416145
Tooth infection 12.48 9.70 71 131825 14041 50459187
Body temperature increased 12.43 9.70 41 131855 31300 50441928
Magnetic resonance imaging thoracic abnormal 12.38 9.70 4 131892 22 50473206
Vitamin D decreased 12.35 9.70 49 131847 8357 50464871
Rhabdomyolysis 12.30 9.70 56 131840 38971 50434257
Periarthritis 12.29 9.70 20 131876 1955 50471273
Neck pain 12.24 9.70 213 131683 56854 50416374
Symptom recurrence 12.23 9.70 12 131884 702 50472526
Respiration abnormal 12.17 9.70 35 131861 5067 50468161
Hirsutism 12.11 9.70 14 131882 989 50472239
Treatment noncompliance 12.08 9.70 126 131770 30024 50443204
Fracture pain 12.07 9.70 9 131887 361 50472867
Parkinsonism 12.05 9.70 4 131892 8843 50464385
Atypical fracture 12.04 9.70 11 131885 588 50472640
Inflammation 11.93 9.70 93 131803 56819 50416409
Metastases to lung 11.84 9.70 7 131889 11013 50462215
Heart rate increased 11.79 9.70 274 131622 76976 50396252
Stress fracture 11.70 9.70 42 131854 6833 50466395
Neoplasm progression 11.66 9.70 38 131858 29119 50444109
Dermatitis contact 11.60 9.70 49 131847 8597 50464631
Pituitary-dependent Cushing's syndrome 11.58 9.70 3 131893 6 50473222
Neck injury 11.53 9.70 18 131878 1699 50471529
Glucocorticoids increased 11.50 9.70 6 131890 126 50473102
Sedation 11.49 9.70 41 131855 30569 50442659
Renal failure 11.49 9.70 202 131694 106431 50366797
Rales 11.46 9.70 54 131842 9924 50463304
Ulcer 11.46 9.70 22 131874 20178 50453050
Musculoskeletal chest pain 11.44 9.70 85 131811 18401 50454827
Aplastic anaemia 11.38 9.70 3 131893 7700 50465528
Increased bronchial secretion 11.37 9.70 17 131879 1545 50471683
Subarachnoid haemorrhage 11.36 9.70 7 131889 10769 50462459
Alanine aminotransferase increased 11.33 9.70 162 131734 88197 50385031
Obstruction 11.32 9.70 20 131876 2091 50471137
Spirometry abnormal 11.30 9.70 7 131889 206 50473022
Osteonecrosis of jaw 11.28 9.70 45 131851 32481 50440747
Pulmonary arterial hypertension 11.23 9.70 91 131805 20228 50453000
Impaired quality of life 11.17 9.70 38 131858 6018 50467210
Pharyngitis streptococcal 11.11 9.70 49 131847 8759 50464469
Expired product administered 11.03 9.70 35 131861 5347 50467881
Muscle rigidity 10.91 9.70 6 131890 9823 50463405
Myalgia 10.78 9.70 411 131485 123908 50349320
Weight increased 10.78 9.70 636 131260 201255 50271973
Immune thrombocytopenia 10.77 9.70 5 131891 9012 50464216
Vena cava embolism 10.72 9.70 3 131893 9 50473219
Tracheobronchitis bacterial 10.72 9.70 3 131893 9 50473219
Oliguria 10.70 9.70 4 131892 8212 50465016
Brain natriuretic peptide 10.69 9.70 4 131892 36 50473192
Respiratory tract irritation 10.69 9.70 9 131887 431 50472797
Ill-defined disorder 10.68 9.70 91 131805 54563 50418665
Hypothalamic pituitary adrenal axis suppression 10.67 9.70 6 131890 147 50473081
Extrapyramidal disorder 10.64 9.70 9 131887 11761 50461467
Diabetic ketoacidosis 10.55 9.70 19 131877 17853 50455375
Vulvovaginal discomfort 10.51 9.70 19 131877 2022 50471206
Aspergilloma 10.49 9.70 6 131890 152 50473076
Metastases to liver 10.46 9.70 23 131873 20081 50453147
Rash maculo-papular 10.46 9.70 35 131861 26606 50446622
Cystitis interstitial 10.45 9.70 15 131881 1314 50471914
Knee arthroplasty 10.39 9.70 53 131843 35793 50437435
Proteinuria 10.38 9.70 17 131879 16580 50456648
Corneal abrasion 10.35 9.70 12 131884 850 50472378
Haemodynamic instability 10.30 9.70 4 131892 8020 50465208
Ischaemic stroke 10.29 9.70 16 131880 15932 50457296
Stomatitis 10.29 9.70 194 131702 101150 50372078
Laryngitis 10.28 9.70 56 131840 10900 50462328
Cytopenia 10.27 9.70 5 131891 8770 50464458
Vocal cord atrophy 10.27 9.70 3 131893 11 50473217
Selective IgA immunodeficiency 10.27 9.70 3 131893 11 50473217
Myocardial infarction 10.18 9.70 304 131592 88723 50384505
Drug level increased 10.07 9.70 22 131874 19246 50453982
Ageusia 10.06 9.70 58 131838 11525 50461703
Food allergy 10.06 9.70 45 131851 8092 50465136
Hilar lymphadenopathy 10.02 9.70 13 131883 1034 50472194
Aspartate aminotransferase increased 10.00 9.70 143 131753 77855 50395373
Psoriasis 10.00 9.70 243 131653 68757 50404471
Distal intestinal obstruction syndrome 9.99 9.70 8 131888 357 50472871
Coronary artery disease 9.99 9.70 120 131776 29606 50443622
Foot deformity 9.98 9.70 22 131874 19188 50454040
Product taste abnormal 9.96 9.70 17 131879 1728 50471500
Frostbite 9.87 9.70 3 131893 13 50473215
Cellulitis 9.86 9.70 248 131648 70550 50402678
Paraesthesia oral 9.85 9.70 60 131836 12161 50461067
Haemolytic anaemia 9.85 9.70 6 131890 9286 50463942
Ascites 9.85 9.70 54 131842 35807 50437421
Pharyngeal abscess 9.79 9.70 7 131889 263 50472965
Gastroenteritis viral 9.77 9.70 83 131813 18703 50454525
Atrial flutter 9.76 9.70 47 131849 8716 50464512

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 591.94 10.55 521 61252 33328 29479426
Wheezing 187.28 10.55 285 61488 32955 29479799
Toxicity to various agents 184.98 10.55 66 61707 173595 29339159
Sinusitis 177.47 10.55 283 61490 34067 29478687
Infective pulmonary exacerbation of cystic fibrosis 175.35 10.55 127 61646 6109 29506645
Eosinophilic granulomatosis with polyangiitis 159.11 10.55 71 61702 1315 29511439
Cough 159.10 10.55 603 61170 126124 29386630
Dyspnoea 155.66 10.55 1189 60584 325543 29187211
Adrenal suppression 130.13 10.55 47 61726 485 29512269
Productive cough 120.12 10.55 226 61547 31033 29481721
Completed suicide 109.24 10.55 27 61746 90219 29422535
Product dose omission issue 86.17 10.55 414 61359 95969 29416785
Nasal congestion 82.03 10.55 144 61629 18735 29494019
Acute kidney injury 79.52 10.55 286 61487 264981 29247773
Bronchitis 76.82 10.55 209 61564 36659 29476095
Product quality issue 73.99 10.55 125 61648 15770 29496984
Pneumonia 73.63 10.55 1004 60769 319168 29193586
Chronic obstructive pulmonary disease 73.50 10.55 220 61553 40735 29472019
Cystic fibrosis 72.98 10.55 43 61730 1449 29511305
Nasal polyps 71.20 10.55 45 61728 1724 29511030
Thrombocytopenia 58.61 10.55 121 61652 134702 29378052
Sleep disorder due to a general medical condition 56.03 10.55 49 61724 3097 29509657
Hypothalamic pituitary adrenal axis suppression 55.96 10.55 18 61755 126 29512628
Full blood count abnormal 55.73 10.55 107 61666 14906 29497848
Malignant neoplasm progression 52.70 10.55 46 61727 73813 29438941
Product complaint 49.87 10.55 59 61714 5346 29507408
Obstructive airways disorder 49.11 10.55 85 61688 10931 29501823
Epidural lipomatosis 47.08 10.55 25 61748 686 29512068
Cortisol decreased 46.11 10.55 26 61747 805 29511949
Drug abuse 45.58 10.55 60 61713 79823 29432931
Upper respiratory tract infection 45.40 10.55 143 61630 27206 29485548
Sinus disorder 45.30 10.55 59 61714 5896 29506858
Sputum discoloured 43.79 10.55 61 61712 6502 29506252
Cushingoid 43.48 10.55 38 61735 2400 29510354
Victim of child abuse 43.04 10.55 25 61748 820 29511934
Off label use 42.82 10.55 412 61361 300388 29212366
Forced expiratory volume decreased 42.61 10.55 40 61733 2773 29509981
Sputum increased 42.58 10.55 34 61739 1893 29510861
Chorioretinopathy 42.47 10.55 30 61743 1386 29511368
Vocal cord dysfunction 42.22 10.55 15 61758 147 29512607
Anaemia 42.01 10.55 247 61526 200704 29312050
Eosinophil count 41.16 10.55 14 61759 119 29512635
Sleep apnoea syndrome 40.96 10.55 104 61669 17495 29495259
Neutropenia 40.01 10.55 141 61632 131570 29381184
Interstitial lung disease 38.74 10.55 38 61735 57680 29455074
Cushing's syndrome 38.06 10.55 18 61755 383 29512371
Intentional overdose 37.08 10.55 17 61756 38511 29474243
Gastrooesophageal reflux disease 37.03 10.55 147 61626 31349 29481405
Foetal malformation 36.81 10.55 13 61760 125 29512629
Hepatic function abnormal 36.74 10.55 18 61755 39241 29473513
Fatigue 36.52 10.55 892 60881 315929 29196825
Multiple organ dysfunction syndrome 36.42 10.55 47 61726 63069 29449685
Bronchial hyperreactivity 35.84 10.55 27 61746 1379 29511375
Renal impairment 35.30 10.55 73 61700 81260 29431494
Renal failure 34.66 10.55 129 61644 118470 29394284
Influenza 33.89 10.55 175 61598 41706 29471048
Breath sounds abnormal 33.87 10.55 49 61724 5408 29507346
Bronchospasm 33.85 10.55 67 61706 9542 29503212
Chest discomfort 33.71 10.55 187 61586 45796 29466958
Chronic sinusitis 33.22 10.55 28 61745 1683 29511071
Suffocation feeling 32.93 10.55 18 61755 524 29512230
Overdose 32.68 10.55 74 61699 79745 29433009
Rhinorrhoea 32.54 10.55 109 61664 21410 29491344
Trisomy 18 32.37 10.55 13 61760 183 29512571
C-reactive protein increased 32.26 10.55 27 61746 44236 29468518
Upper-airway cough syndrome 31.45 10.55 35 61738 2968 29509786
Dyspnoea exertional 31.29 10.55 155 61618 36335 29476419
Painful respiration 30.94 10.55 23 61750 1151 29511603
Bone marrow failure 29.89 10.55 10 61763 27439 29485315
Secondary adrenocortical insufficiency 29.81 10.55 22 61751 1089 29511665
Dysphonia 29.71 10.55 98 61675 19098 29493656
Bronchial obstruction 29.58 10.55 24 61749 1367 29511387
Rhabdomyolysis 29.52 10.55 51 61722 60757 29451997
Pancytopenia 29.48 10.55 83 61690 83085 29429669
Chest injury 28.96 10.55 24 61749 1409 29511345
Walking aid user 28.32 10.55 24 61749 1453 29511301
Pulmonary function test decreased 28.23 10.55 39 61734 4124 29508630
Respiratory tract congestion 28.12 10.55 44 61729 5205 29507549
Coma 27.61 10.55 25 61748 39425 29473329
Status asthmaticus 27.38 10.55 13 61760 279 29512475
Septic shock 27.27 10.55 56 61717 62504 29450250
Rhinitis 26.92 10.55 41 61732 4737 29508017
Blood immunoglobulin E increased 26.31 10.55 26 61747 1921 29510833
Adrenal insufficiency 26.19 10.55 66 61707 11048 29501706
Cytomegalovirus infection 26.09 10.55 8 61765 23207 29489547
Hyperkalaemia 25.88 10.55 56 61717 61336 29451418
General physical health deterioration 25.61 10.55 119 61654 102738 29410016
Ear infection 25.60 10.55 54 61719 8046 29504708
Dyspnoea paroxysmal nocturnal 25.41 10.55 22 61751 1372 29511382
Metabolic acidosis 25.03 10.55 25 61748 37637 29475117
Skin striae 24.50 10.55 14 61759 445 29512309
Leukopenia 24.41 10.55 49 61724 55154 29457600
Lung hernia 24.28 10.55 8 61765 61 29512693
Growth retardation 24.27 10.55 23 61750 1613 29511141
Rhinalgia 24.14 10.55 13 61760 367 29512387
Treatment failure 24.00 10.55 25 61748 36914 29475840
Nasal inflammation 23.70 10.55 11 61762 224 29512530
Neuroleptic malignant syndrome 23.48 10.55 3 61770 16145 29496609
Dermatitis atopic 23.48 10.55 26 61747 2193 29510561
Bronchiectasis 23.30 10.55 46 61727 6539 29506215
Nasopharyngitis 23.23 10.55 208 61565 59457 29453297
Drug resistance 23.19 10.55 8 61765 21532 29491222
Foetal exposure during pregnancy 23.06 10.55 22 61751 33845 29478909
Hypertrophic osteoarthropathy 22.74 10.55 8 61765 76 29512678
Sinus congestion 22.43 10.55 37 61736 4575 29508179
Febrile neutropenia 22.33 10.55 140 61633 112100 29400654
Cerebral infarction 22.06 10.55 12 61761 24663 29488091
Eosinophil count increased 21.99 10.55 48 61725 7321 29505433
Vision blurred 21.66 10.55 151 61622 40025 29472729
Throat irritation 21.58 10.55 53 61720 8732 29504022
Headache 21.50 10.55 495 61278 173512 29339242
Central obesity 21.32 10.55 13 61760 467 29512287
Anxiety 21.24 10.55 272 61501 85093 29427661
Carcinoid tumour of the gastrointestinal tract 21.17 10.55 7 61766 54 29512700
Blood creatinine increased 20.86 10.55 99 61674 85003 29427751
Depressed level of consciousness 20.80 10.55 28 61745 36914 29475840
Peripheral swelling 20.76 10.55 214 61559 63525 29449229
Bradycardia 20.75 10.55 69 61704 65560 29447194
Blood creatine phosphokinase increased 20.73 10.55 33 61740 40611 29472143
Plethoric face 20.69 10.55 4 61769 0 29512754
Drug reaction with eosinophilia and systemic symptoms 20.48 10.55 17 61756 27975 29484779
Hypersomnia 20.45 10.55 59 61714 10695 29502059
Forced expiratory flow decreased 20.45 10.55 9 61764 161 29512593
Hospitalisation 20.36 10.55 165 61608 45823 29466931
Cholestasis 20.13 10.55 12 61761 23450 29489304
Delirium 20.09 10.55 32 61741 39365 29473389
Seasonal allergy 19.72 10.55 37 61736 5065 29507689
Therapeutic product effect incomplete 19.61 10.55 145 61628 39160 29473594
Hot flush 19.61 10.55 72 61701 14798 29497956
Oral candidiasis 19.60 10.55 58 61715 10664 29502090
Atopy 19.40 10.55 8 61765 121 29512633
Premature baby 19.33 10.55 6 61767 17274 29495480
Hypoacusis 19.16 10.55 70 61703 14353 29498401
Loss of personal independence in daily activities 19.00 10.55 104 61669 25336 29487418
Anosmia 18.81 10.55 22 61751 1969 29510785
Altered state of consciousness 18.79 10.55 9 61764 19880 29492874
Mucosal inflammation 18.77 10.55 23 61750 31572 29481182
Rash maculo-papular 18.72 10.55 14 61759 24275 29488479
Drug interaction 18.65 10.55 295 61478 197090 29315664
Antineutrophil cytoplasmic antibody positive 18.45 10.55 13 61760 598 29512156
Eosinophilic oesophagitis 18.27 10.55 9 61764 210 29512544
Nasal oedema 18.27 10.55 10 61763 292 29512462
Cystic fibrosis respiratory infection suppression 18.23 10.55 9 61764 211 29512543
Neutrophil count decreased 18.14 10.55 40 61733 43527 29469227
Stridor 18.12 10.55 23 61750 2240 29510514
Serotonin syndrome 18.01 10.55 7 61766 17505 29495249
Eye disorder 17.92 10.55 46 61727 7788 29504966
Nasal discomfort 17.91 10.55 17 61756 1195 29511559
Nervous system neoplasm 17.88 10.55 8 61765 149 29512605
Tendon calcification 17.74 10.55 6 61767 50 29512704
Juvenile idiopathic arthritis 17.70 10.55 18 61755 1376 29511378
Contraindicated product administered 17.66 10.55 8 61765 18258 29494496
Stress 17.51 10.55 90 61683 21400 29491354
Illness 17.18 10.55 41 61732 6633 29506121
Lacrimation increased 17.02 10.55 42 61731 6938 29505816
Eosinophilic bronchitis 16.92 10.55 8 61765 170 29512584
Middle insomnia 16.83 10.55 37 61736 5671 29507083
Panic reaction 16.74 10.55 17 61756 1298 29511456
Hepatocellular injury 16.69 10.55 12 61761 21231 29491523
Agranulocytosis 16.63 10.55 11 61762 20329 29492425
Rhinitis allergic 16.54 10.55 24 61749 2656 29510098
Feeling cold 16.12 10.55 49 61724 9142 29503612
Cortisol abnormal 15.93 10.55 5 61768 32 29512722
Snoring 15.84 10.55 24 61749 2760 29509994
Increased viscosity of bronchial secretion 15.74 10.55 8 61765 200 29512554
Lower respiratory tract infection 15.72 10.55 102 61671 26400 29486354
Abnormal behaviour 15.59 10.55 92 61681 23035 29489719
Anger 15.44 10.55 54 61719 10836 29501918
Migraine 15.40 10.55 59 61714 12371 29500383
Nasal disorder 15.37 10.55 17 61756 1432 29511322
Injection site pruritus 15.13 10.55 36 61737 5813 29506941
Nasal obstruction 14.95 10.55 11 61762 542 29512212
Central nervous system mass 14.78 10.55 6 61767 87 29512667
Personality change 14.75 10.55 31 61742 4607 29508147
Cerebral haemorrhage 14.67 10.55 27 61746 31399 29481355
Dry skin 14.62 10.55 91 61682 23216 29489538
Toxic epidermal necrolysis 14.60 10.55 10 61763 18143 29494611
Sepsis 14.57 10.55 210 61563 142472 29370282
Kidney infection 14.54 10.55 31 61742 4652 29508102
Melaena 14.36 10.55 27 61746 31149 29481605
Gamma-glutamyltransferase increased 14.32 10.55 21 61752 26716 29486038
Choking 14.26 10.55 30 61743 4461 29508293
Neck pain 14.25 10.55 85 61688 21362 29491392
Back pain 14.21 10.55 296 61477 101988 29410766
Wall motion score index abnormal 14.19 10.55 6 61767 97 29512657
Insulin autoimmune syndrome 13.98 10.55 8 61765 255 29512499
Oesophageal candidiasis 13.89 10.55 27 61746 3794 29508960
Drug intolerance 13.87 10.55 53 61720 48326 29464428
Platelet count decreased 13.72 10.55 146 61627 104526 29408228
Blood lactate dehydrogenase increased 13.64 10.55 12 61761 19197 29493557
Disseminated intravascular coagulation 13.58 10.55 13 61760 19967 29492787
Cardiac arrest 13.52 10.55 114 61659 85477 29427277
Oropharyngeal pain 13.46 10.55 106 61667 29179 29483575
Shock 13.33 10.55 15 61758 21389 29491365
Oxygen saturation decreased 13.28 10.55 148 61625 44789 29467965
Blood urea increased 13.26 10.55 24 61749 28088 29484666
Multiple allergies 13.23 10.55 19 61754 2083 29510671
Haemophilus infection 13.23 10.55 13 61760 954 29511800
Poor quality device used 13.08 10.55 12 61761 808 29511946
Hepatic failure 13.06 10.55 29 61744 31483 29481271
Rheumatoid arthritis 12.99 10.55 30 61743 32122 29480632
Atelectasis 12.92 10.55 65 61708 15327 29497427
Tracheal disorder 12.89 10.55 6 61767 123 29512631
Hepatotoxicity 12.89 10.55 11 61762 17856 29494898
Smoke sensitivity 12.80 10.55 6 61767 125 29512629
Cardiac failure 12.79 10.55 105 61668 79182 29433572
Inhalation therapy 12.69 10.55 4 61769 26 29512728
Haemoptysis 12.66 10.55 108 61665 30442 29482312
Drug-induced liver injury 12.61 10.55 16 61757 21639 29491115
Lipohypertrophy 12.58 10.55 7 61766 211 29512543
Increased bronchial secretion 12.55 10.55 16 61757 1565 29511189
Night sweats 12.49 10.55 63 61710 14869 29497885
Allergic sinusitis 12.47 10.55 5 61768 70 29512684
Throat clearing 12.44 10.55 7 61766 216 29512538
Respiratory disorder 12.39 10.55 69 61704 16914 29495840
Eye swelling 12.34 10.55 43 61730 8614 29504140
Sneezing 12.33 10.55 28 61745 4386 29508368
Cardio-respiratory arrest 12.31 10.55 59 61714 50542 29462212
Hyperbilirubinaemia 12.31 10.55 8 61765 14926 29497828
Hypomagnesaemia 12.30 10.55 11 61762 17457 29495297
Pre-existing condition improved 12.22 10.55 19 61754 2234 29510520
Child abuse 12.21 10.55 7 61766 224 29512530
Blood testosterone decreased 12.19 10.55 26 61747 3904 29508850
Airway remodelling 12.14 10.55 6 61767 141 29512613
Poisoning 12.06 10.55 3 61770 9990 29502764
Hypertrichosis 12.04 10.55 8 61765 334 29512420
Wrong technique in device usage process 11.98 10.55 13 61760 1072 29511682
Hypoaesthesia 11.90 10.55 167 61606 53300 29459454
Contusion 11.89 10.55 108 61665 30987 29481767
Urticaria 11.87 10.55 170 61603 54490 29458264
Synovitis 11.80 10.55 4 61769 10886 29501868
Meralgia paraesthetica 11.70 10.55 6 61767 153 29512601
Extrapyramidal disorder 11.70 10.55 4 61769 10827 29501927
Hemiparesis 11.62 10.55 8 61765 14478 29498276
Otitis media 11.57 10.55 20 61753 2569 29510185
Nephropathy toxic 11.57 10.55 4 61769 10752 29502002
Increased tendency to bruise 11.55 10.55 24 61749 3538 29509216
Graft versus host disease 11.41 10.55 3 61770 9625 29503129
IPEX syndrome 11.38 10.55 3 61770 9 29512745
Deformity thorax 11.28 10.55 4 61769 39 29512715
Penile erythema 11.25 10.55 6 61767 166 29512588
Hyposmia 11.19 10.55 6 61767 168 29512586
Blood bilirubin increased 11.15 10.55 35 61738 33858 29478896
Bronchopulmonary aspergillosis allergic 11.15 10.55 9 61764 509 29512245
Increased upper airway secretion 11.12 10.55 15 61758 1551 29511203
Respiratory syncytial virus infection 11.11 10.55 24 61749 3635 29509119
Infusion site pruritus 11.10 10.55 9 61764 512 29512242
Respiratory tract infection 11.03 10.55 63 61710 15588 29497166
Alanine aminotransferase increased 10.97 10.55 95 61678 70849 29441905
Administration site swelling 10.87 10.55 6 61767 178 29512576
Abdominal discomfort 10.81 10.55 150 61623 47753 29465001
Cystitis 10.81 10.55 40 61733 8252 29504502
Weight decreased 10.80 10.55 401 61372 150504 29362250
Hand-foot-and-mouth disease 10.77 10.55 4 61769 45 29512709
Muscle spasms 10.61 10.55 193 61580 64889 29447865
Suicidal ideation 10.56 10.55 115 61658 34601 29478153
Pancreatic failure 10.56 10.55 10 61763 701 29512053

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 950.83 9.66 1138 148555 94087 64254952
Toxicity to various agents 422.57 9.66 158 149535 363355 63985684
Completed suicide 417.72 9.66 26 149667 224388 64124651
Wheezing 399.97 9.66 691 149002 79888 64269151
Infective pulmonary exacerbation of cystic fibrosis 377.82 9.66 271 149422 11525 64337514
Cough 323.51 9.66 1473 148220 300675 64048364
Dyspnoea 313.36 9.66 2782 146911 715892 63633147
Eosinophilic granulomatosis with polyangiitis 286.45 9.66 138 149555 2744 64346295
Chest discomfort 215.77 9.66 676 149017 115430 64233609
Bronchitis 196.43 9.66 627 149066 108116 64240923
Sinusitis 194.37 9.66 761 148932 145167 64203872
Product quality issue 176.67 9.66 277 149416 29522 64319517
Synovitis 171.48 9.66 16 149677 99074 64249965
Productive cough 171.36 9.66 463 149230 72740 64276299
Chronic obstructive pulmonary disease 166.94 9.66 450 149243 70598 64278441
Contraindicated product administered 146.56 9.66 35 149658 107794 64241245
Off label use 145.91 9.66 867 148826 631939 63717100
Obstructive airways disorder 145.11 9.66 221 149472 22964 64326075
Acute kidney injury 141.67 9.66 550 149143 448690 63900349
Nasal congestion 139.28 9.66 377 149316 59281 64289758
Adrenal suppression 136.31 9.66 65 149628 1262 64347777
Drug abuse 135.36 9.66 69 149624 132305 64216734
Pneumonia 135.03 9.66 1931 147762 557645 63791394
Neutropenia 134.36 9.66 218 149475 239406 64109633
Product dose omission issue 133.09 9.66 840 148853 193907 64155132
Thrombocytopenia 127.92 9.66 201 149492 223600 64125439
Nasal polyps 124.59 9.66 87 149606 3542 64345497
Sputum increased 122.13 9.66 86 149607 3549 64345490
Intentional overdose 116.84 9.66 32 149661 89912 64259127
Pemphigus 112.93 9.66 7 149686 60694 64288345
Hand deformity 108.96 9.66 10 149683 62761 64286278
Pericarditis 100.79 9.66 13 149680 62503 64286536
Upper respiratory tract infection 99.60 9.66 383 149310 72402 64276637
Cystic fibrosis 98.89 9.66 74 149619 3360 64345679
Anxiety 96.71 9.66 802 148891 201847 64147192
Treatment failure 94.82 9.66 79 149614 116737 64232302
Sleep apnoea syndrome 92.32 9.66 210 149483 29622 64319417
Drug intolerance 91.93 9.66 186 149507 187806 64161233
General physical health deterioration 91.90 9.66 212 149481 204213 64144826
Malignant neoplasm progression 90.80 9.66 77 149616 112794 64236245
Systemic lupus erythematosus 87.86 9.66 35 149658 77577 64271462
Pancytopenia 84.44 9.66 126 149567 143183 64205856
Full blood count abnormal 82.85 9.66 201 149492 29556 64319483
Chronic sinusitis 81.11 9.66 86 149607 6206 64342833
Gastrooesophageal reflux disease 79.64 9.66 393 149300 82750 64266289
Forced expiratory volume decreased 78.32 9.66 88 149605 6779 64342260
Product complaint 76.29 9.66 115 149578 11839 64337200
Febrile neutropenia 75.48 9.66 206 149487 187451 64161588
Sleep disorder due to a general medical condition 74.88 9.66 94 149599 8140 64340899
Multiple organ dysfunction syndrome 74.68 9.66 75 149618 101338 64247701
Overdose 73.71 9.66 163 149530 159403 64189636
Dyspnoea exertional 73.12 9.66 352 149341 73378 64275661
Hepatic function abnormal 72.80 9.66 29 149664 64284 64284755
Sputum discoloured 71.91 9.66 140 149553 17716 64331323
Dysphonia 70.06 9.66 252 149441 46130 64302909
Cushing's syndrome 69.52 9.66 37 149656 914 64348125
Coma 68.97 9.66 61 149632 87554 64261485
Anaemia 67.73 9.66 558 149135 378122 63970917
Duodenal ulcer perforation 64.38 9.66 4 149689 34621 64314418
Joint swelling 61.91 9.66 273 149420 215109 64133930
Cardio-respiratory arrest 60.42 9.66 84 149609 98309 64250730
Hepatic enzyme increased 59.79 9.66 133 149560 129810 64219229
Leukopenia 59.64 9.66 89 149604 101153 64247886
Mucosal inflammation 59.07 9.66 36 149657 62548 64286491
Renal impairment 59.06 9.66 142 149551 134875 64214164
Bronchial neoplasm 59.02 9.66 26 149667 417 64348622
Bone marrow failure 58.73 9.66 19 149674 47933 64301106
Hypothalamic pituitary adrenal axis suppression 58.59 9.66 23 149670 271 64348768
Chest pain 57.68 9.66 817 148876 235163 64113876
Pulmonary function test decreased 57.55 9.66 73 149620 6388 64342651
Drug reaction with eosinophilia and systemic symptoms 57.31 9.66 27 149666 54190 64294849
Respiratory symptom 56.75 9.66 51 149642 3002 64346037
Metabolic acidosis 56.33 9.66 49 149644 70909 64278130
Wound 55.80 9.66 57 149636 76420 64272619
Platelet count decreased 55.52 9.66 201 149492 167510 64181529
Rhinitis allergic 54.84 9.66 80 149613 7998 64341041
Therapeutic product effect decreased 54.78 9.66 116 149577 115235 64233804
Interstitial lung disease 54.62 9.66 89 149604 97643 64251396
C-reactive protein increased 54.40 9.66 85 149608 94824 64254215
Drug interaction 53.73 9.66 559 149134 361524 63987515
Adrenal insufficiency 53.36 9.66 143 149550 22344 64326695
Breath sounds abnormal 52.58 9.66 96 149597 11573 64337466
Nasal turbinate hypertrophy 52.55 9.66 26 149667 549 64348490
Drug ineffective 52.49 9.66 1518 148175 838729 63510310
Cortisol decreased 52.48 9.66 38 149655 1639 64347400
Rhinitis 51.63 9.66 91 149602 10674 64338365
Migraine 51.54 9.66 284 149409 62393 64286646
Helicobacter infection 51.04 9.66 13 149680 38349 64310690
Glossodynia 50.96 9.66 45 149648 64651 64284388
Bronchial obstruction 50.87 9.66 43 149650 2331 64346708
Headache 50.81 9.66 1597 148096 527870 63821169
Influenza 49.89 9.66 420 149273 106111 64242928
Rheumatoid arthritis 49.81 9.66 204 149489 164090 64184949
Muscle injury 49.31 9.66 3 149690 26434 64322605
Folliculitis 49.10 9.66 6 149687 30071 64318968
Rhinorrhoea 48.82 9.66 271 149422 59698 64289341
Cytomegalovirus infection 48.74 9.66 13 149680 37186 64311853
Deep vein thrombosis 48.37 9.66 413 149280 104769 64244270
Eosinophil count increased 47.78 9.66 103 149590 14009 64335030
Hepatotoxicity 46.92 9.66 17 149676 39945 64309094
Injury 44.89 9.66 252 149441 55740 64293299
Emotional distress 44.74 9.66 184 149509 35854 64313185
Depressed level of consciousness 44.73 9.66 75 149618 81361 64267678
Hyperkalaemia 44.50 9.66 106 149587 101023 64248016
Endometrial ablation 44.45 9.66 26 149667 775 64348264
Gamma-glutamyltransferase increased 44.27 9.66 29 149664 48481 64300558
Hepatocellular injury 44.13 9.66 25 149668 45210 64303829
Arthropathy 44.10 9.66 139 149554 120828 64228211
Salpingo-oophorectomy unilateral 44.06 9.66 22 149671 474 64348565
Sopor 43.63 9.66 8 149685 29653 64319386
Maternal exposure during pregnancy 43.40 9.66 99 149594 95785 64253254
Cushingoid 42.74 9.66 69 149624 7534 64341505
Rhonchi 42.29 9.66 46 149647 3417 64345622
Poor quality device used 42.28 9.66 36 149657 1971 64347068
Infusion related reaction 41.68 9.66 218 149475 164249 64184790
Sleep disorder due to general medical condition, insomnia type 41.07 9.66 6 149687 26264 64322775
Depression 40.99 9.66 625 149068 182666 64166373
Sinusitis fungal 40.94 9.66 33 149660 1673 64347366
Serotonin syndrome 40.85 9.66 20 149673 39262 64309777
Toxic epidermal necrolysis 40.07 9.66 18 149675 37148 64311891
Feeling abnormal 39.92 9.66 480 149213 133122 64215917
Status asthmaticus 39.91 9.66 26 149667 942 64348097
Victim of child abuse 39.90 9.66 25 149668 846 64348193
Epidural lipomatosis 39.74 9.66 25 149668 852 64348187
Upper-airway cough syndrome 39.33 9.66 72 149621 8698 64340341
Agranulocytosis 38.94 9.66 20 149673 38209 64310830
Rhabdomyolysis 38.90 9.66 98 149595 91628 64257411
Bradycardia 38.90 9.66 142 149551 118077 64230962
Oropharyngeal pain 38.80 9.66 345 149348 88522 64260517
Bladder prolapse 38.34 9.66 27 149666 1114 64347925
Stress 38.14 9.66 256 149437 60278 64288761
Dermatitis atopic 38.07 9.66 46 149647 3830 64345209
Septic shock 37.84 9.66 122 149571 105315 64243724
Cholecystitis chronic 37.62 9.66 73 149620 9214 64339825
Viral infection 37.61 9.66 175 149518 35965 64313074
Acute respiratory failure 37.59 9.66 221 149472 49713 64299326
Eosinophil count 37.46 9.66 13 149680 105 64348934
Alopecia 37.45 9.66 228 149465 165462 64183577
Neutrophil count decreased 37.17 9.66 77 149616 77119 64271920
Nasal discomfort 37.13 9.66 48 149645 4280 64344759
Emphysema 37.01 9.66 93 149600 13976 64335063
Altered state of consciousness 36.90 9.66 21 149672 37881 64311158
Bronchial haemorrhage 36.68 9.66 27 149666 1195 64347844
Renal failure 36.53 9.66 259 149434 181429 64167610
Hospitalisation 36.00 9.66 298 149395 74909 64274130
Myelosuppression 35.99 9.66 6 149687 23824 64325215
Sinus disorder 35.65 9.66 103 149590 16805 64332234
Seasonal allergy 34.57 9.66 81 149612 11645 64337394
Throat irritation 34.48 9.66 159 149534 32552 64316487
Cholestasis 34.40 9.66 32 149661 44840 64304199
Posterior reversible encephalopathy syndrome 34.16 9.66 6 149687 22940 64326099
Acute sinusitis 33.87 9.66 45 149648 4121 64344918
Toxic skin eruption 33.65 9.66 3 149690 19281 64329758
Blood immunoglobulin E increased 33.55 9.66 43 149650 3801 64345238
Hypotension 33.45 9.66 653 149040 380321 63968718
Blood creatinine increased 33.28 9.66 182 149511 135600 64213439
Pulmonary embolism 33.07 9.66 500 149193 145856 64203183
Dermatitis allergic 32.79 9.66 93 149600 15016 64334023
Middle insomnia 32.70 9.66 84 149609 12793 64336246
Cardiac failure 32.68 9.66 177 149516 132196 64216843
Bronchiectasis 32.62 9.66 89 149604 14051 64334988
Cardiac arrest 32.26 9.66 217 149476 153847 64195192
Pneumocystis jirovecii pneumonia 32.03 9.66 12 149681 27622 64321417
Bone erosion 31.93 9.66 78 149615 11517 64337522
Haemoptysis 31.85 9.66 209 149484 48839 64300200
Vision blurred 31.74 9.66 335 149358 89981 64259058
Oesophageal spasm 31.64 9.66 34 149659 2491 64346548
Palpitations 31.47 9.66 376 149317 104112 64244927
Electrocardiogram QT prolonged 31.33 9.66 88 149605 79360 64269679
Prolonged expiration 31.26 9.66 21 149672 802 64348237
Bronchospasm 31.22 9.66 116 149577 21566 64327473
Ear infection 31.05 9.66 122 149571 23282 64325757
Bronchial disorder 31.04 9.66 31 149662 2084 64346955
Oropharyngeal oedema 30.88 9.66 14 149679 241 64348798
Hiatus hernia 30.62 9.66 109 149584 19848 64329191
Dizziness 30.24 9.66 1253 148440 428910 63920129
Pulmonary mass 30.11 9.66 123 149570 23893 64325146
Vocal cord dysfunction 29.57 9.66 16 149677 409 64348630
Urticaria 29.41 9.66 493 149200 146824 64202215
Extrapyramidal disorder 29.36 9.66 5 149688 19547 64329492
Death 29.26 9.66 875 148818 481830 63867209
Rash maculo-papular 29.01 9.66 40 149653 46986 64302053
Pulmonary hypertension 28.73 9.66 185 149508 42954 64306085
Neuroleptic malignant syndrome 28.73 9.66 11 149682 24985 64324054
Eosinophilic bronchitis 28.58 9.66 15 149678 360 64348679
Eye pruritus 28.53 9.66 79 149614 12580 64336459
Increased upper airway secretion 28.53 9.66 38 149655 3489 64345550
Female genital tract fistula 28.51 9.66 33 149660 2625 64346414
Chorioretinopathy 28.27 9.66 30 149663 2167 64346872
Drug resistance 28.15 9.66 24 149669 35078 64313961
Respiratory disorder 27.94 9.66 161 149532 35950 64313089
Burning sensation 27.18 9.66 203 149490 49461 64299578
Embolism venous 27.17 9.66 37 149656 3470 64345569
Neutropenic sepsis 27.15 9.66 10 149683 23262 64325777
Sinus operation 27.04 9.66 26 149667 1669 64347370
Growth retardation 26.92 9.66 25 149668 1536 64347503
Bronchial hyperreactivity 26.63 9.66 31 149662 2481 64346558
Haemophilus infection 26.52 9.66 27 149666 1858 64347181
Central obesity 26.45 9.66 24 149669 1431 64347608
Throat clearing 26.16 9.66 23 149670 1315 64347724
Liver injury 25.85 9.66 19 149674 29913 64319126
Concussion 25.81 9.66 57 149636 7881 64341158
Oxygen saturation decreased 25.71 9.66 370 149323 106806 64242233
Fatigue 25.69 9.66 2043 147650 746687 63602352
Suicide attempt 25.59 9.66 82 149611 70925 64278114
Oesophagogastroduodenoscopy 25.28 9.66 11 149682 171 64348868
Cerebral infarction 25.23 9.66 35 149658 41009 64308030
Shock 25.15 9.66 31 149662 38209 64310830
Secondary adrenocortical insufficiency 24.96 9.66 29 149664 2316 64346723
Cor pulmonale 24.91 9.66 27 149666 1998 64347041
Blood lactate dehydrogenase increased 24.87 9.66 24 149669 33054 64315985
Rectal prolapse 24.79 9.66 25 149668 1701 64347338
Diverticulum 24.62 9.66 77 149616 13121 64335918
Cerebral haemorrhage 24.56 9.66 51 149642 51039 64298000
Respiratory arrest 24.55 9.66 54 149639 52931 64296108
Jaundice 24.55 9.66 47 149646 48465 64300574
Hepatic failure 24.41 9.66 58 149635 55336 64293703
Heart sounds 24.38 9.66 16 149677 587 64348452
Gastrointestinal disorder 24.38 9.66 116 149577 89593 64259446
Hypoxia 24.30 9.66 312 149381 87837 64261202
Infusion site erythema 24.23 9.66 51 149642 6822 64342217
Nasal mucosal disorder 24.21 9.66 13 149680 327 64348712
Respiratory tract congestion 23.70 9.66 87 149606 16078 64332961
Ectropion 23.45 9.66 13 149680 349 64348690
Sinus congestion 23.41 9.66 84 149609 15355 64333684
Tumour lysis syndrome 23.28 9.66 8 149685 19432 64329607
Growth failure 22.82 9.66 11 149682 219 64348820
Product use in unapproved indication 22.49 9.66 282 149411 176336 64172703
Chest injury 22.48 9.66 28 149665 2405 64346634
Confusional state 22.47 9.66 449 149244 260695 64088344
Hypothermia 22.39 9.66 9 149684 19847 64329192
Impaired healing 22.38 9.66 69 149624 60404 64288635
Feeling cold 22.00 9.66 111 149582 23567 64325472
Neck pain 21.97 9.66 229 149464 61304 64287735
Granuloma 21.94 9.66 48 149645 6593 64342446
Cystic fibrosis respiratory infection suppression 21.91 9.66 13 149680 398 64348641
Hypervolaemia 21.82 9.66 158 149535 38127 64310912
Oesophageal pain 21.69 9.66 32 149661 3231 64345808
Thrombotic microangiopathy 21.48 9.66 6 149687 16649 64332390
Biliary dyskinesia 21.44 9.66 27 149666 2345 64346694
Eczema 21.38 9.66 130 149563 29590 64319449
Lactic acidosis 21.38 9.66 72 149621 61338 64287701
Nephropathy toxic 21.34 9.66 7 149686 17507 64331532
Aphonia 21.33 9.66 56 149637 8641 64340398
Inhalation therapy 21.16 9.66 7 149686 48 64348991
Suffocation feeling 21.16 9.66 22 149671 1552 64347487
Drug-induced liver injury 20.90 9.66 50 149643 47593 64301446
Weight increased 20.76 9.66 645 149048 212703 64136336
Anosmia 20.74 9.66 37 149656 4380 64344659
Anuria 20.73 9.66 9 149684 18955 64330084
Eosinophilic pneumonia chronic 20.66 9.66 12 149681 353 64348686
Iron deficiency anaemia 20.61 9.66 103 149590 21786 64327253
Discomfort 20.59 9.66 107 149586 80771 64268268
Alanine aminotransferase increased 20.42 9.66 215 149478 138816 64210223
Swelling 20.33 9.66 256 149437 159962 64189077
Blood corticotrophin 20.27 9.66 4 149689 0 64349039
Hypokalaemia 20.23 9.66 183 149510 121720 64227319
Blood creatine phosphokinase increased 20.15 9.66 69 149624 58489 64290550
Tinnitus 20.11 9.66 142 149551 33991 64315048
Dyspnoea paroxysmal nocturnal 20.04 9.66 24 149669 1980 64347059
Aplastic anaemia 19.95 9.66 4 149689 13916 64335123
Procedural pain 19.90 9.66 80 149613 15428 64333611
Nasal inflammation 19.62 9.66 14 149679 590 64348449
Lung hernia 19.60 9.66 7 149686 62 64348977
Blister 19.57 9.66 109 149584 80858 64268181
Rheumatoid nodule 19.52 9.66 3 149690 12648 64336391
Weight decreased 19.51 9.66 830 148863 284909 64064130
Forced expiratory flow decreased 19.44 9.66 10 149683 230 64348809
Bronchitis bacterial 19.39 9.66 19 149674 1248 64347791
Palmar-plantar erythrodysaesthesia syndrome 19.34 9.66 23 149670 28796 64320243
Candida infection 19.27 9.66 132 149561 31287 64317752
Airway remodelling 19.24 9.66 9 149684 167 64348872
Skin striae 19.24 9.66 20 149673 1410 64347629
Osteoporosis 19.21 9.66 165 149528 41915 64307124
Blood bilirubin increased 19.01 9.66 69 149624 57484 64291555
Cystic fibrosis related diabetes 19.00 9.66 9 149684 172 64348867
Respiratory tract infection 18.86 9.66 150 149543 37257 64311782
Lymphopenia 18.85 9.66 19 149674 25638 64323401
Nodular vasculitis 18.82 9.66 6 149687 36 64349003
Swelling face 18.73 9.66 215 149478 58951 64290088
Hypertrophic osteoarthropathy 18.70 9.66 8 149685 119 64348920
Insomnia 18.69 9.66 596 149097 197240 64151799
Expiratory reserve volume decreased 18.68 9.66 7 149686 72 64348967
Acute respiratory distress syndrome 18.60 9.66 39 149654 38896 64310143
Delirium 18.49 9.66 90 149603 69104 64279935
Gluten sensitivity 18.45 9.66 11 149682 340 64348699
Carcinoid tumour of the gastrointestinal tract 18.43 9.66 7 149686 75 64348964
Shock haemorrhagic 18.31 9.66 8 149685 16783 64332256
Drug eruption 18.29 9.66 35 149658 36101 64312938
Pulmonary arterial hypertension 18.27 9.66 111 149582 25256 64323783
Subarachnoid haemorrhage 18.26 9.66 10 149683 18428 64330611
Sneezing 18.25 9.66 77 149616 15174 64333865
Ankle fracture 18.17 9.66 75 149618 14635 64334404
Affective disorder 17.84 9.66 44 149649 6536 64342503
Labelled drug-drug interaction medication error 17.79 9.66 15 149678 22047 64326992
Urinary tract infection 17.72 9.66 681 149012 230915 64118124
Diastolic dysfunction 17.69 9.66 53 149640 8822 64340217
Intentional self-injury 17.62 9.66 25 149668 29019 64320020
Hyperthermia 17.61 9.66 7 149686 15543 64333496
Ischaemic stroke 17.60 9.66 25 149668 29010 64320029
Pharyngitis streptococcal 17.50 9.66 52 149641 8616 64340423
Infusion site swelling 17.49 9.66 39 149654 5426 64343613
Heart rate increased 17.46 9.66 324 149369 98351 64250688
Osteonecrosis of jaw 17.31 9.66 42 149651 39783 64309256
Acute myeloid leukaemia 17.30 9.66 23 149670 27440 64321599
Sepsis 17.21 9.66 405 149288 229936 64119103
Melaena 17.16 9.66 65 149628 53483 64295556
Illness 17.09 9.66 98 149595 21840 64327199
Inappropriate antidiuretic hormone secretion 16.96 9.66 16 149677 22273 64326766
Sinus headache 16.95 9.66 33 149660 4174 64344865
Peak expiratory flow rate decreased 16.91 9.66 13 149680 615 64348424
Proteinuria 16.68 9.66 24 149669 27699 64321340
Fracture displacement 16.65 9.66 17 149676 1174 64347865
Stevens-Johnson syndrome 16.62 9.66 34 149659 34215 64314824
Encephalopathy 16.61 9.66 75 149618 58744 64290295
Drug level increased 16.55 9.66 34 149659 34162 64314877
Laryngeal pain 16.54 9.66 39 149654 5629 64343410
Acute generalised exanthematous pustulosis 16.47 9.66 6 149687 14052 64334987
Fluid retention 16.43 9.66 211 149482 59395 64289644
Limb injury 16.39 9.66 102 149591 23403 64325636
Muscle spasms 16.37 9.66 436 149257 140587 64208452
Torsade de pointes 16.36 9.66 10 149683 17353 64331686
Oral candidiasis 16.36 9.66 101 149592 23111 64325928
Painful respiration 16.03 9.66 27 149666 3054 64345985
Therapeutic product effect incomplete 16.02 9.66 333 149360 103149 64245890
Ear discomfort 15.98 9.66 45 149648 7235 64341804
Cytopenia 15.90 9.66 8 149685 15463 64333576
Intentional product use issue 15.89 9.66 143 149550 95221 64253818
Throat tightness 15.84 9.66 100 149593 23060 64325979
Cytomegalovirus viraemia 15.76 9.66 3 149690 10825 64338214
Cardiac septal defect 15.67 9.66 9 149684 259 64348780
Disease progression 15.59 9.66 233 149460 141447 64207592
Pruritus 15.57 9.66 880 148813 311520 64037519
Musculoskeletal stiffness 15.57 9.66 197 149496 123009 64226030
Respiratory syncytial virus bronchiolitis 15.53 9.66 11 149682 458 64348581
Brain oedema 15.48 9.66 17 149676 22058 64326981
Paraesthesia oral 15.48 9.66 66 149627 13065 64335974
Obesity 15.47 9.66 91 149602 20471 64328568
Abnormal behaviour 15.43 9.66 132 149561 33490 64315549
Eosinophil count abnormal 15.38 9.66 12 149681 580 64348459
Hyponatraemia 15.29 9.66 247 149446 148092 64200947
Temperature intolerance 15.25 9.66 48 149645 8207 64340832
Ear canal erythema 15.20 9.66 3 149690 0 64349039
Increased viscosity of bronchial secretion 15.20 9.66 11 149682 474 64348565
Bronchoscopy 15.19 9.66 6 149687 72 64348967
Metastases to bone 15.16 9.66 15 149678 20420 64328619
Injection site inflammation 15.15 9.66 27 149666 3194 64345845
Circulatory collapse 15.12 9.66 35 149658 33697 64315342
Transplant rejection 15.08 9.66 11 149682 17390 64331649
Smoke sensitivity 15.08 9.66 11 149682 480 64348559
Diabetic ketoacidosis 15.02 9.66 29 149664 29816 64319223
Disseminated intravascular coagulation 14.96 9.66 33 149660 32315 64316724
Hysterectomy 14.85 9.66 35 149658 5050 64343989
Multiple allergies 14.84 9.66 38 149655 5776 64343263
Lymphocyte count decreased 14.66 9.66 47 149646 40652 64308387
Hot flush 14.63 9.66 168 149525 46067 64302972
Tricuspid valve incompetence 14.61 9.66 78 149615 16925 64332114
Mobility decreased 14.61 9.66 128 149565 85712 64263327
Hepatitis cholestatic 14.56 9.66 5 149688 12150 64336889
Rhinovirus infection 14.45 9.66 39 149654 6117 64342922
Acute hepatic failure 14.38 9.66 24 149669 26088 64322951
Road traffic accident 14.27 9.66 121 149572 30624 64318415
Pre-existing condition improved 14.15 9.66 33 149660 4729 64344310
Hyperbilirubinaemia 14.15 9.66 17 149676 21188 64327851
Gastroenteritis viral 14.00 9.66 86 149607 19643 64329396
Parkinsonism 13.94 9.66 8 149685 14365 64334674
Central nervous system mass 13.92 9.66 6 149687 91 64348948
Tubulointerstitial nephritis 13.91 9.66 32 149661 30877 64318162
Pneumococcal infection 13.87 9.66 13 149680 808 64348231
Respiratory tract irritation 13.78 9.66 11 149682 550 64348489
Chronic respiratory failure 13.77 9.66 23 149670 2583 64346456
Haematuria 13.76 9.66 83 149610 60388 64288651
Pneumonia aspiration 13.67 9.66 81 149612 59190 64289849
Wall motion score index abnormal 13.58 9.66 6 149687 97 64348942
Eosinophilic oesophagitis 13.36 9.66 10 149683 454 64348585
Croup infectious 13.34 9.66 11 149682 576 64348463
Epilepsy 13.32 9.66 37 149656 33494 64315545
Nocturnal dyspnoea 13.30 9.66 16 149677 1326 64347713
Polyneuropathy 13.22 9.66 16 149677 19878 64329161
Haemoglobin decreased 13.21 9.66 348 149345 194715 64154324
Atopy 13.17 9.66 8 149685 256 64348783
Fracture pain 13.14 9.66 9 149684 355 64348684
Bronchial wall thickening 13.11 9.66 19 149674 1888 64347151
Hilar lymphadenopathy 12.97 9.66 17 149676 1536 64347503
Pemphigoid 12.92 9.66 7 149686 12979 64336060
Hypomagnesaemia 12.89 9.66 44 149649 37332 64311707
Haemolytic anaemia 12.84 9.66 11 149682 16042 64332997
Aspartate aminotransferase increased 12.83 9.66 198 149495 119590 64229449
Dermatitis contact 12.83 9.66 48 149645 8952 64340087
Hypersomnia 12.79 9.66 84 149609 19633 64329406
Lung opacity 12.78 9.66 25 149668 3174 64345865
Lemierre syndrome 12.75 9.66 6 149687 113 64348926
Pain in extremity 12.72 9.66 841 148852 302244 64046795
Cardiogenic shock 12.72 9.66 36 149657 32391 64316648
Anger 12.71 9.66 71 149622 15670 64333369
Periarthritis 12.70 9.66 22 149671 2545 64346494
Therapy partial responder 12.66 9.66 4 149689 10244 64338795
Stridor 12.59 9.66 32 149661 4842 64344197
Electrocardiogram QRS complex prolonged 12.55 9.66 3 149690 9241 64339798
Hyperuricaemia 12.55 9.66 4 149689 10187 64338852
Carpal tunnel syndrome 12.53 9.66 71 149622 15757 64333282
Immune thrombocytopenia 12.45 9.66 10 149683 15056 64333983
Musculoskeletal chest pain 12.44 9.66 89 149604 21390 64327649
Purpura 12.41 9.66 13 149680 17233 64331806
Psychotic disorder 12.41 9.66 40 149653 34538 64314501
Hip arthroplasty 12.34 9.66 19 149674 21332 64327707
Arthropod bite 12.34 9.66 39 149654 6682 64342357
Educational problem 12.29 9.66 9 149684 395 64348644
Hypercalcaemia 12.23 9.66 35 149658 31381 64317658
Tendon calcification 12.20 9.66 6 149687 125 64348914
Loss of personal independence in daily activities 12.16 9.66 236 149457 72218 64276821
Glucocorticoids increased 12.16 9.66 6 149687 126 64348913
Ascites 12.15 9.66 89 149604 61912 64287127
Product substitution issue 12.14 9.66 77 149616 17784 64331255
Panic reaction 12.07 9.66 28 149665 3999 64345040
FEV1/FVC ratio decreased 12.07 9.66 6 149687 128 64348911
Cystitis interstitial 12.05 9.66 14 149679 1118 64347921
Blood urea increased 12.05 9.66 57 149636 44096 64304943
Myalgia 12.02 9.66 466 149227 158151 64190888
Peritonitis 12.01 9.66 25 149668 24998 64324041
Cortisol abnormal 11.96 9.66 5 149688 70 64348969
Vena cava embolism 11.92 9.66 3 149690 6 64349033
Malaise 11.90 9.66 1071 148622 395176 63953863
Child abuse 11.84 9.66 7 149686 213 64348826
Hereditary angioedema 11.67 9.66 27 149666 3849 64345190
Bronchial secretion retention 11.65 9.66 21 149672 2506 64346533
Nightmare 11.59 9.66 86 149607 20907 64328132
Fracture 11.52 9.66 16 149677 18739 64330300
Penile erythema 11.47 9.66 6 149687 143 64348896
Eye disorder 11.41 9.66 79 149614 18790 64330249
Enuresis 11.38 9.66 22 149671 2768 64346271
Snoring 11.33 9.66 30 149663 4652 64344387
Anaphylactic reaction 11.30 9.66 223 149470 68441 64280598
Kidney transplant rejection 11.24 9.66 4 149689 9507 64339532
Dry skin 11.24 9.66 174 149519 50987 64298052
Expired product administered 11.23 9.66 35 149658 5952 64343087
Memory impairment 11.15 9.66 269 149424 85413 64263626
Increased bronchial secretion 11.10 9.66 22 149671 2820 64346219
IPEX syndrome 11.07 9.66 3 149690 9 64349030
Neurotoxicity 11.06 9.66 30 149663 27374 64321665
Staphylococcal infection 11.00 9.66 172 149521 50506 64298533
Total lung capacity abnormal 10.96 9.66 6 149687 157 64348882
Vitamin D decreased 10.96 9.66 41 149652 7646 64341393
Bacterial tracheitis 10.96 9.66 4 149689 38 64349001
Insulin autoimmune syndrome 10.93 9.66 8 149685 351 64348688
Bronchopulmonary aspergillosis allergic 10.92 9.66 16 149677 1606 64347433
Therapy non-responder 10.89 9.66 99 149594 65800 64283239
Inflammation 10.84 9.66 98 149595 65202 64283837
Transaminases increased 10.79 9.66 60 149633 44534 64304505
Cholecystectomy 10.76 9.66 42 149651 7990 64341049
Electrocardiogram ST-T segment abnormal 10.76 9.66 9 149684 481 64348558
Device dislocation 10.71 9.66 85 149608 21093 64327946
Gallbladder disorder 10.71 9.66 72 149621 16958 64332081
Dystonia 10.70 9.66 17 149676 18848 64330191
Stress fracture 10.66 9.66 33 149660 5591 64343448
Back pain 10.64 9.66 695 148998 249476 64099563
Muscle rigidity 10.64 9.66 15 149678 17458 64331581
Thermal burn 10.60 9.66 34 149659 5872 64343167
Distal intestinal obstruction syndrome 10.58 9.66 10 149683 628 64348411
Irritability 10.52 9.66 131 149562 36615 64312424
Otitis media 10.48 9.66 32 149661 5381 64343658
Restlessness 10.48 9.66 52 149641 39733 64309306
Food allergy 10.47 9.66 41 149652 7810 64341229
Metastases to lung 10.44 9.66 12 149681 15252 64333787
Right ventricular systolic pressure 10.40 9.66 3 149690 12 64349027
Pituitary-dependent Cushing's syndrome 10.40 9.66 3 149690 12 64349027
Senile osteoporosis 10.40 9.66 5 149688 99 64348940
Atypical fracture 10.35 9.66 10 149683 646 64348393
Akathisia 10.34 9.66 7 149686 11503 64337536
Hirsutism 10.30 9.66 12 149681 961 64348078
Pickwickian syndrome 10.28 9.66 8 149685 385 64348654
Gallbladder injury 10.27 9.66 13 149680 1135 64347904
Meralgia paraesthetica 10.27 9.66 7 149686 274 64348765
Vascular parkinsonism 10.22 9.66 5 149688 103 64348936
Hypoaesthesia 10.15 9.66 407 149286 138701 64210338
Lip swelling 10.12 9.66 116 149577 31791 64317248
Cystitis 10.10 9.66 147 149546 42528 64306511
Ventricular tachycardia 10.09 9.66 43 149650 34222 64314817
Cataplexy 10.08 9.66 11 149682 820 64348219
Orthopnoea 10.07 9.66 45 149648 9089 64339950
Uterine perforation 9.99 9.66 33 149660 5787 64343252
Vulvovaginal discomfort 9.98 9.66 15 149678 1540 64347499
Transplant evaluation 9.96 9.66 15 149678 1542 64347497
Asthmatic crisis 9.96 9.66 16 149677 1740 64347299
Pharyngeal erythema 9.94 9.66 16 149677 1743 64347296
Antineutrophil cytoplasmic antibody positive 9.92 9.66 12 149681 1000 64348039
Febrile bone marrow aplasia 9.91 9.66 7 149686 11248 64337791
Mood swings 9.90 9.66 72 149621 17396 64331643
Neuroendocrine tumour of the lung metastatic 9.88 9.66 5 149688 111 64348928
Obsessive-compulsive disorder 9.82 9.66 29 149664 4789 64344250
Live birth 9.82 9.66 7 149686 11197 64337842
Progressive multifocal leukoencephalopathy 9.81 9.66 17 149676 18215 64330824
Accidental exposure to product 9.81 9.66 30 149663 26334 64322705
Oedema peripheral 9.81 9.66 589 149104 209728 64139311
Eye discharge 9.80 9.66 30 149663 5054 64343985
Arthritis bacterial 9.79 9.66 3 149690 7836 64341203
Femoral neck fracture 9.76 9.66 4 149689 8720 64340319
Nephrotic syndrome 9.75 9.66 5 149688 9562 64339477
Vocal cord atrophy 9.70 9.66 3 149690 16 64349023
Product taste abnormal 9.69 9.66 17 149676 1986 64347053
Secretion discharge 9.69 9.66 54 149639 11910 64337129
Blood pressure inadequately controlled 9.66 9.66 31 149662 5353 64343686

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 (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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 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. 8, 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 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

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
6699 IUPHAR_LIGAND_ID
90566-53-3 SECONDARY_CAS_RN
O2GMZ0LF5W UNII
444036 PUBCHEM_CID
5311101 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
CUT2W21N7U UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DYMISTA HUMAN PRESCRIPTION DRUG LABEL 2 0037-0245 SPRAY, METERED 50 ug NASAL NDA 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 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 0093-3608 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 0093-7516 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 0093-7518 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
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
CHILDRENS FLONASEALLERGY RELIEF HUMAN OTC DRUG LABEL 1 0135-0582 SPRAY, METERED 50 ug NASAL NDA 16 sections
CHILDRENS FLONASEALLERGY RELIEF HUMAN OTC DRUG LABEL 1 0135-0582 SPRAY, METERED 50 ug NASAL NDA 16 sections
FLUTICASONE PROPIONATE HUMAN PRESCRIPTION DRUG LABEL 1 0168-0332 CREAM 0.50 mg TOPICAL ANDA 21 sections
FLUTICASONE PROPIONATE HUMAN PRESCRIPTION DRUG LABEL 1 0168-0434 LOTION 0.50 mg TOPICAL NDA authorized generic 26 sections
FLOVENTDISKUS HUMAN PRESCRIPTION DRUG LABEL 1 0173-0600 POWDER, METERED 50 ug RESPIRATORY (INHALATION) NDA 26 sections
FLOVENTDISKUS HUMAN PRESCRIPTION DRUG LABEL 1 0173-0600 POWDER, METERED 50 ug RESPIRATORY (INHALATION) NDA 26 sections
FLOVENTDISKUS HUMAN PRESCRIPTION DRUG LABEL 1 0173-0601 POWDER, METERED 250 ug RESPIRATORY (INHALATION) NDA 26 sections
FLOVENTDISKUS HUMAN PRESCRIPTION DRUG LABEL 1 0173-0601 POWDER, METERED 250 ug RESPIRATORY (INHALATION) NDA 26 sections
FLOVENTDISKUS HUMAN PRESCRIPTION DRUG LABEL 1 0173-0602 POWDER, METERED 100 ug RESPIRATORY (INHALATION) NDA 26 sections
FLOVENTDISKUS HUMAN PRESCRIPTION DRUG LABEL 1 0173-0602 POWDER, METERED 100 ug RESPIRATORY (INHALATION) NDA 26 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0695 POWDER 100 ug RESPIRATORY (INHALATION) NDA 27 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0695 POWDER 100 ug RESPIRATORY (INHALATION) NDA 27 sections