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

Stem definitionDrug idCAS RN
4554 397864-44-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fluticasone furoate
  • avamys
  • veramyst
Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti‑inflammatory activity. Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor. The precise mechanism of corticosteroid action on asthma is not known. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma.
  • Molecular weight: 538.58
  • Formula: C27H29F3O6S
  • CLOGP: 4.26
  • LIPINSKI: 1
  • HAC: 6
  • HDO: 1
  • TPSA: 93.81
  • ALOGS: -4.09
  • ROTB: 6
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

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

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 4.95 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 13.40 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 10.60 hours Lombardo F, Berellini G, Obach RS
BA (Bioavailability) 0.01 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K
BA (Bioavailability) 0.14 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 4.014 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.816 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 33.963 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 23.605 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 0.180 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 0.540 % High 1
herg hERG pIC50 4.926 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 90.157 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 243.220 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 0.340 % High 1
kinase-safety-class ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,JAK3,MAP3K7,MAPK10,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIM2,PRKDC,STK33,TEK,ZAP70 32
kinase-selectivity-class AXL,GRK2,MAP2K6,STK33 4
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 3.062 Moderate 0.77
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.624 High 1
mh-clint Mouse hepatocyte intrinsic clearance 100 High 1
mppb Mouse plasma protein binding (% unbound) 0.430 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 18.707 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 0.740 % High 1
rat-kpuu-brain Rat brain Kpuu 0.378 % Moderate 0.77
rh-clint Rat hepatocyte intrinsic clearance 161.808 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 2.940 % High 1
rppb Rat plasma protein binding (% unbound) 0.320 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 1.652 uM High 1

Approvals:

DateAgencyCompanyOrphan
April 22, 2009 PMDA GlaxoSmithKline K.K.
April 27, 2007 FDA GLAXOSMITHKLINE
Jan. 11, 2008 EMA GlaxoSmithKline (Ireland) Limited

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
Macular degeneration 896.25 13.87 362 27411 37608 90563066
Asthma 491.42 13.87 479 27294 241681 90358993
Obstructive airways disorder 476.96 13.87 207 27566 25662 90575012
Wheezing 376.26 13.87 412 27361 237668 90363006
Full blood count abnormal 323.03 13.87 177 27596 36420 90564254
Chronic sinusitis 293.15 13.87 144 27629 23658 90577016
Therapeutic product effect incomplete 262.66 13.87 310 27463 193586 90407088
Gastrooesophageal reflux disease 226.95 13.87 267 27506 166070 90434604
Nasal congestion 219.19 13.87 191 27582 83223 90517451
Paraesthesia oral 179.25 13.87 115 27658 31544 90569130
Throat clearing 177.03 13.87 60 27713 3787 90596887
Procedural pain 159.37 13.87 109 27664 33251 90567423
Vaginal flatulence 154.20 13.87 76 27697 12562 90588112
Cough 143.91 13.87 336 27437 368626 90232048
Sleep disorder due to a general medical condition 143.48 13.87 115 27658 44623 90556051
Female genital tract fistula 142.80 13.87 81 27692 17787 90582887
Nasal obstruction 141.19 13.87 46 27727 2566 90598108
Proctitis 140.68 13.87 76 27697 15183 90585491
Dyspnoea 132.94 13.87 577 27196 880378 89720296
Bronchial neoplasm 131.98 13.87 31 27742 499 90600175
Bronchial haemorrhage 130.61 13.87 32 27741 621 90600053
Blepharospasm 129.81 13.87 119 27654 55326 90545348
Bronchiectasis 128.59 13.87 82 27691 22248 90578426
Blood immunoglobulin E increased 128.17 13.87 49 27724 4376 90596298
Radiculopathy 127.01 13.87 76 27697 18429 90582245
Vaginal discharge 126.02 13.87 77 27696 19387 90581287
Taste disorder 124.82 13.87 122 27651 61424 90539250
Nasal polyps 119.70 13.87 61 27712 10819 90589855
Productive cough 118.98 13.87 132 27641 76931 90523743
Nasal turbinate hypertrophy 114.97 13.87 31 27742 890 90599784
Endometrial ablation 111.56 13.87 31 27742 998 90599676
Secretion discharge 110.95 13.87 66 27707 15830 90584844
Malignant mediastinal neoplasm 110.57 13.87 33 27740 1375 90599299
Oral candidiasis 109.15 13.87 89 27684 35366 90565308
Rhinorrhoea 104.43 13.87 132 27641 88184 90512490
Dyspnoea exertional 103.38 13.87 119 27654 72169 90528505
Bronchial disorder 103.22 13.87 32 27741 1518 90599156
Chronic obstructive pulmonary disease 103.01 13.87 120 27653 73709 90526965
Respiratory tract infection 99.58 13.87 106 27667 58972 90541702
Hypothalamo-pituitary disorder 99.22 13.87 34 27739 2218 90598456
Dyslipidaemia 95.01 13.87 51 27722 10056 90590618
Hyper IgE syndrome 92.20 13.87 23 27750 482 90600192
Total lung capacity increased 91.88 13.87 40 27733 4981 90595693
Epilepsy 91.11 13.87 119 27654 82087 90518587
Rhonchi 86.33 13.87 33 27740 2945 90597729
Asthma-chronic obstructive pulmonary disease overlap syndrome 86.31 13.87 38 27735 4861 90595813
Dust allergy 85.42 13.87 24 27749 805 90599869
Weight decreased 84.40 13.87 282 27491 379628 90221046
Eczema 84.08 13.87 92 27681 52778 90547896
Asthmatic crisis 80.90 13.87 28 27745 1882 90598792
Overweight 79.35 13.87 38 27735 5896 90594778
Chest discomfort 77.11 13.87 146 27627 138219 90462455
Carbuncle 76.44 13.87 25 27748 1411 90599263
Injection site scab 76.21 13.87 21 27752 655 90600019
Haematochezia 72.96 13.87 99 27674 70814 90529860
Toxicity to various agents 71.96 13.87 4 27769 287842 90312832
Restrictive pulmonary disease 71.45 13.87 27 27746 2335 90598339
Colitis ulcerative 69.52 13.87 89 27684 60177 90540497
Frequent bowel movements 68.72 13.87 86 27687 56849 90543825
Respiratory tract inflammation 68.70 13.87 19 27754 601 90600073
Sarcoidosis 68.51 13.87 42 27731 10631 90590043
Monoclonal immunoglobulin present 66.87 13.87 25 27748 2099 90598575
Rhinitis 66.35 13.87 45 27728 13527 90587147
Rectal haemorrhage 64.05 13.87 101 27672 82643 90518031
Sputum discoloured 62.36 13.87 51 27722 20340 90580334
Sensitivity to weather change 62.18 13.87 37 27736 8877 90591797
Granuloma 60.35 13.87 32 27741 6153 90594521
Rhinitis allergic 59.95 13.87 46 27727 16739 90583935
Migraine 57.93 13.87 158 27615 190234 90410440
Affective disorder 56.06 13.87 33 27740 7760 90592914
Sleep apnoea syndrome 53.54 13.87 57 27716 31690 90568984
Drug ineffective 52.09 13.87 649 27124 1383649 89217025
Colitis 50.87 13.87 83 27690 69859 90530815
Paraesthesia 50.43 13.87 180 27593 250146 90350528
Breath sounds abnormal 50.26 13.87 40 27733 15346 90585328
Death 50.01 13.87 40 27733 456511 90144163
Blood test abnormal 47.13 13.87 44 27729 20908 90579766
Respiratory disorder 45.90 13.87 76 27697 64740 90535934
Lung hyperinflation 45.89 13.87 17 27756 1391 90599283
Malaise 44.81 13.87 320 27453 585666 90015008
Respiratory rate increased 44.73 13.87 38 27735 15963 90584711
Alopecia 44.22 13.87 52 27721 495019 90105655
Hand deformity 43.78 13.87 18 27755 296344 90304330
Movement disorder 43.54 13.87 49 27724 28970 90571704
Polycystic ovaries 43.47 13.87 25 27748 5629 90595045
Lung neoplasm malignant 43.46 13.87 45 27728 24228 90576446
Dyspepsia 42.93 13.87 146 27627 198014 90402660
Eosinophilic granulomatosis with polyangiitis 42.56 13.87 19 27754 2511 90598163
Fibrosis 42.28 13.87 25 27748 5927 90594747
Wrist deformity 41.07 13.87 20 27753 3218 90597456
Fatigue 40.66 13.87 199 27574 1153824 89446850
Cardiac murmur 40.52 13.87 38 27735 18156 90582518
Systemic lupus erythematosus 40.50 13.87 31 27742 361865 90238809
Crystal arthropathy 40.01 13.87 11 27762 340 90600334
Nasal oedema 39.95 13.87 25 27748 6559 90594115
Haemoptysis 39.67 13.87 50 27723 33270 90567404
Blood pressure systolic increased 39.43 13.87 67 27706 58278 90542396
Glossodynia 39.40 13.87 25 27748 321754 90278920
Treatment failure 38.06 13.87 23 27750 303905 90296769
Erythema 38.04 13.87 155 27618 229091 90371583
General physical health deterioration 37.76 13.87 32 27741 355083 90245591
Acute kidney injury 37.73 13.87 26 27747 320361 90280313
Diabetes mellitus 36.78 13.87 69 27704 64806 90535868
Pemphigus 36.57 13.87 28 27745 326836 90273838
Abdominal discomfort 35.70 13.87 57 27716 477271 90123403
Thrombocytopenia 35.46 13.87 10 27763 208715 90391959
Forced expiratory volume decreased 35.11 13.87 22 27751 5786 90594888
Memory impairment 34.83 13.87 136 27637 197108 90403566
Helicobacter infection 34.78 13.87 13 27760 226837 90373837
Renal cyst 34.67 13.87 30 27743 12920 90587754
Nephropathy 34.50 13.87 26 27747 9209 90591465
Lactose intolerance 34.49 13.87 18 27755 3351 90597323
Discomfort 32.65 13.87 22 27751 274313 90326361
Secondary hypogonadism 31.83 13.87 8 27765 173 90600501
Neutropenia 31.10 13.87 15 27758 224889 90375785
Body height decreased 30.62 13.87 27 27746 11922 90588752
Ligament pain 30.03 13.87 8 27765 219 90600455
Wound 29.03 13.87 30 27743 302950 90297724
Bone density decreased 28.99 13.87 31 27742 17314 90583360
Sinusitis 28.30 13.87 191 27582 342897 90257777
Herpes zoster 27.23 13.87 77 27696 94567 90506107
Loss of personal independence in daily activities 26.63 13.87 97 27676 136008 90464666
Allergy to animal 26.48 13.87 12 27761 1642 90599032
Impaired healing 26.26 13.87 20 27753 234179 90366495
Contraindicated product administered 26.09 13.87 36 27737 320103 90280571
Drug interaction 25.78 13.87 28 27745 276425 90324249
Congenital hypogonadotropic hypogonadism 25.73 13.87 5 27768 30 90600644
Hypopituitarism foetal 25.73 13.87 5 27768 30 90600644
Stress 25.17 13.87 68 27705 81327 90519347
Seasonal allergy 25.02 13.87 33 27740 22950 90577724
Ankle fracture 24.94 13.87 31 27742 20339 90580335
Radioallergosorbent test positive 24.82 13.87 5 27768 37 90600637
Overdose 24.23 13.87 9 27764 157700 90442974
Disease progression 23.96 13.87 9 27764 156606 90444068
Illness 23.88 13.87 67 27706 81902 90518772
Joint swelling 23.85 13.87 77 27696 503223 90097451
Pericarditis 23.42 13.87 29 27744 270122 90330552
Eye pruritus 23.24 13.87 36 27737 28991 90571683
Ear pruritus 22.89 13.87 18 27755 6785 90593889
Rales 22.51 13.87 26 27747 15801 90584873
Purpura 22.25 13.87 25 27748 14753 90585921
Diarrhoea 22.15 13.87 183 27590 939007 89661667
Pancytopenia 21.89 13.87 5 27768 120258 90480416
Anhidrosis 21.81 13.87 6 27767 186 90600488
Steroid diabetes 21.78 13.87 12 27761 2490 90598184
Aspartate aminotransferase increased 21.50 13.87 3 27770 102934 90497740
Respiratory gas exchange disorder 21.29 13.87 7 27766 402 90600272
Chondrocalcinosis pyrophosphate 21.24 13.87 9 27764 1049 90599625
Hypokalaemia 20.97 13.87 7 27766 131109 90469565
Hepatic enzyme increased 20.94 13.87 50 27723 360686 90239988
Pulmonary mass 20.72 13.87 34 27739 28738 90571936
Rash 20.68 13.87 151 27622 795949 89804725
White blood cell count decreased 20.41 13.87 13 27760 167096 90433578
Abscess 20.37 13.87 27 27746 18864 90581810
Malignant neoplasm progression 20.36 13.87 4 27769 106866 90493808
Muscle injury 19.91 13.87 15 27758 176639 90424035
Febrile neutropenia 19.78 13.87 12 27761 158337 90442337
Sinus tachycardia 19.60 13.87 33 27740 28480 90572194
Restless legs syndrome 19.59 13.87 29 27744 22441 90578233
Congenital pharyngeal anomaly 19.48 13.87 4 27769 33 90600641
Eosinophil count increased 19.47 13.87 22 27751 13059 90587615
Cleft palate 19.35 13.87 9 27764 1307 90599367
Haemoglobin decreased 19.24 13.87 13 27760 161943 90438731
Pertussis 19.16 13.87 8 27765 899 90599775
Dehydration 18.90 13.87 19 27754 194428 90406246
Pancreatic calcification 18.78 13.87 4 27769 40 90600634
Dysstasia 18.58 13.87 30 27743 25022 90575652
Seizure 18.47 13.87 12 27761 152617 90448057
Stent placement 18.35 13.87 13 27760 4190 90596484
Subclavian vein thrombosis 18.01 13.87 10 27763 2106 90598568
Swelling 17.90 13.87 67 27706 418991 90181683
Angioedema 17.90 13.87 52 27721 64824 90535850
Alanine aminotransferase increased 17.77 13.87 7 27766 118331 90482343
Platelet count decreased 17.65 13.87 10 27763 136959 90463715
Breast adenoma 17.62 13.87 4 27769 55 90600619
Sinus pain 17.58 13.87 14 27759 5375 90595299
Pulmonary function test decreased 17.56 13.87 13 27760 4481 90596193
Ovarian cyst 17.53 13.87 24 27749 17294 90583380
Arthropathy 17.36 13.87 56 27717 366186 90234488
Breast conserving surgery 17.10 13.87 8 27765 1177 90599497
Duodenal ulcer perforation 16.92 13.87 26 27747 221262 90379412
Decreased appetite 16.87 13.87 59 27714 376481 90224193
Pharyngeal disorder 16.52 13.87 10 27763 2473 90598201
Cardiac arrest 16.10 13.87 6 27767 104929 90495745
Limb injury 16.01 13.87 32 27741 31476 90569198
Subendocardial ischaemia 15.98 13.87 4 27769 85 90600589
Sneezing 15.98 13.87 31 27742 29838 90570836
Constipation 15.82 13.87 143 27630 280252 90320422
Fall 15.79 13.87 85 27688 481725 90118949
Eosinophilia 15.74 13.87 30 27743 28503 90572171
Confusional state 15.68 13.87 63 27710 386142 90214532
Hypoaesthesia 15.62 13.87 156 27617 314054 90286620
Madarosis 15.32 13.87 11 27762 3618 90597056
Irritable bowel syndrome 15.27 13.87 25 27748 207423 90393251
Hypotension 15.25 13.87 50 27723 325347 90275327
Atopy 15.21 13.87 5 27768 287 90600387
Mobility decreased 15.15 13.87 34 27739 250700 90349974
Gingival abscess 14.86 13.87 7 27766 1046 90599628
Frustration tolerance decreased 14.79 13.87 15 27758 7881 90592793
Dyspnoea at rest 14.68 13.87 12 27761 4779 90595895
Bronchitis 14.34 13.87 88 27685 152839 90447835
Bradycardia 14.26 13.87 4 27769 83843 90516831
Atrial fibrillation 14.23 13.87 12 27761 133599 90467075
Patient isolation 14.18 13.87 3 27770 29 90600645
Fibromyalgia 14.14 13.87 26 27747 206243 90394431
Pain 14.08 13.87 402 27371 995939 89604735
Alternaria infection 13.97 13.87 5 27768 371 90600303

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 335.03 19.51 217 12584 62097 42546437
Appendicolith 244.73 19.51 106 12695 13350 42595184
Appendicitis 204.51 19.51 107 12694 20506 42588028
Wheezing 189.84 19.51 146 12655 54635 42553899
Ventricular fibrillation 159.36 19.51 104 12697 30019 42578515
Cardiogenic shock 136.72 19.51 101 12700 35539 42572995
Stress 134.10 19.51 109 12692 44103 42564431
Myasthenia gravis 113.97 19.51 67 12734 16070 42592464
Nasal polyps 110.09 19.51 42 12759 3809 42604725
Blood uric acid increased 108.35 19.51 64 12737 15483 42593051
Abdominal distension 106.29 19.51 119 12682 71616 42536918
Ascites 105.20 19.51 106 12695 56572 42551962
Dry mouth 99.70 19.51 88 12713 39791 42568743
Hyperphosphataemia 97.14 19.51 56 12745 12948 42595586
Nasal congestion 92.09 19.51 74 12727 29427 42579107
Sputum discoloured 90.29 19.51 49 12752 10083 42598451
Incorrect route of product administration 88.97 19.51 67 12734 24238 42584296
Obstructive airways disorder 87.86 19.51 67 12734 24692 42583842
Iron deficiency 86.27 19.51 49 12752 11012 42597522
Blood cholesterol increased 85.43 19.51 68 12733 26673 42581861
Chronic obstructive pulmonary disease 82.20 19.51 98 12703 63016 42545518
Therapeutic product effect incomplete 80.87 19.51 103 12698 70836 42537698
Foetal malformation 79.65 19.51 17 12784 176 42608358
Analgesic therapy 76.68 19.51 38 12763 6486 42602048
Blood phosphorus increased 73.00 19.51 46 12755 12479 42596055
Sleep disorder therapy 71.79 19.51 37 12764 6857 42601677
Sleep disorder 69.84 19.51 79 12722 48016 42560518
Neuralgia 66.90 19.51 58 12743 25589 42582945
Hypophosphataemia 66.33 19.51 53 12748 20892 42587642
Hyponatraemia 65.83 19.51 113 12688 101349 42507185
Full blood count abnormal 65.00 19.51 61 12740 29815 42578719
Bacterial infection 60.79 19.51 57 12744 27822 42580712
Multiple organ dysfunction syndrome 60.24 19.51 106 12695 96929 42511605
Drug therapy 60.04 19.51 32 12769 6348 42602186
Blood test abnormal 57.29 19.51 40 12761 12866 42595668
Lung opacity 56.98 19.51 30 12771 5807 42602727
Total lung capacity decreased 54.82 19.51 25 12776 3545 42604989
Trisomy 18 54.35 19.51 17 12784 848 42607686
Bacteroides infection 52.35 19.51 22 12779 2565 42605969
Sleep disorder due to a general medical condition 50.70 19.51 42 12759 17411 42591123
Rhinorrhoea 49.18 19.51 54 12747 31740 42576794
SARS-CoV-2 sepsis 48.73 19.51 12 12789 243 42608291
Aortic stenosis 48.18 19.51 31 12770 8714 42599820
Lung diffusion disorder 47.90 19.51 11 12790 163 42608371
Cough 47.52 19.51 139 12662 177964 42430570
Dyspnoea 47.31 19.51 259 12542 442362 42166172
Toxicity to various agents 45.97 19.51 7 12794 229129 42379405
Diabetes mellitus 45.79 19.51 72 12729 60015 42548519
Swelling 44.95 19.51 68 12733 54817 42553717
Rhinitis 43.77 19.51 33 12768 11944 42596590
Chronic sinusitis 43.58 19.51 21 12780 3371 42605163
Seasonal allergy 43.01 19.51 28 12773 8027 42600507
Acute kidney injury 42.84 19.51 29 12772 367308 42241226
Lower respiratory tract infection 42.51 19.51 57 12744 41149 42567385
General physical health deterioration 42.21 19.51 120 12681 151126 42457408
Constipation 41.69 19.51 125 12676 162166 42446368
Inguinal hernia repair 41.28 19.51 11 12790 308 42608226
Antacid therapy 39.77 19.51 22 12779 4695 42603839
Forced expiratory volume decreased 39.46 19.51 26 12775 7604 42600930
Abdominal pain 39.23 19.51 136 12665 190335 42418199
Fungal disease carrier 38.54 19.51 11 12790 399 42608135
Anticoagulant therapy 37.82 19.51 21 12780 4514 42604020
Intentional product misuse 37.58 19.51 67 12734 61833 42546701
Nasal oedema 35.58 19.51 10 12791 343 42608191
Ulcer 34.65 19.51 33 12768 16408 42592126
Productive cough 34.14 19.51 58 12743 51509 42557025
Activated partial thromboplastin time prolonged 33.67 19.51 32 12769 15871 42592663
Ocular discomfort 33.55 19.51 17 12784 3040 42605494
Oropharyngeal candidiasis 33.42 19.51 12 12789 917 42607617
Loss of personal independence in daily activities 32.94 19.51 56 12745 49760 42558774
End stage renal disease 32.58 19.51 32 12769 16526 42592008
Somnolence 31.89 19.51 104 12697 141001 42467533
Middle insomnia 31.81 19.51 23 12778 7810 42600724
Thrombosis 31.58 19.51 66 12735 68445 42540089
Blood calcium increased 30.24 19.51 23 12778 8431 42600103
Diarrhoea 29.35 19.51 59 12742 460790 42147744
Neutropenia 28.70 19.51 12 12789 199419 42409115
Bronchiectasis 28.55 19.51 31 12770 17988 42590546
Platelet count decreased 28.31 19.51 4 12797 138577 42469957
Central obesity 28.17 19.51 10 12791 739 42607795
Thrombocytopenia 28.11 19.51 11 12790 190268 42418266
Eosinophilic pneumonia chronic 27.80 19.51 8 12793 299 42608235
Drug intolerance 27.66 19.51 69 12732 80355 42528179
Nasal disorder 27.52 19.51 13 12788 1996 42606538
Chest discomfort 26.69 19.51 59 12742 63557 42544977
Hyperlipidaemia 25.68 19.51 32 12769 21484 42587050
Blood immunoglobulin E increased 25.44 19.51 15 12786 3610 42604924
Troponin increased 25.44 19.51 30 12771 19032 42589502
Febrile neutropenia 25.41 19.51 12 12789 185691 42422843
Anosmia 25.23 19.51 17 12784 5159 42603375
Gastroenteritis eosinophilic 25.22 19.51 7 12794 229 42608305
Gout 24.73 19.51 36 12765 28019 42580515
Rhinitis allergic 24.64 19.51 15 12786 3827 42604707
Glaucoma 24.26 19.51 20 12781 8228 42600306
Renal failure 23.48 19.51 7 12794 143719 42464815
Nasal septum deviation 22.99 19.51 10 12791 1268 42607266
Pharyngeal paraesthesia 22.74 19.51 9 12792 900 42607634
Polyp 22.12 19.51 15 12786 4599 42603935
Blood alkaline phosphatase abnormal 22.00 19.51 8 12793 634 42607900
Drug interaction 21.80 19.51 29 12772 266970 42341564
Respiratory failure 21.37 19.51 6 12795 128126 42480408
Pneumonia haemophilus 21.37 19.51 9 12792 1055 42607479
Pyrexia 21.36 19.51 55 12746 393987 42214547
Alpha 2 globulin decreased 21.28 19.51 4 12797 20 42608514
Otosalpingitis 21.28 19.51 4 12797 20 42608514
Free androgen index decreased 21.12 19.51 4 12797 21 42608513
Sex hormone binding globulin decreased 21.12 19.51 4 12797 21 42608513
Androgen insensitivity syndrome 20.96 19.51 4 12797 22 42608512
Testicular microlithiasis 20.67 19.51 4 12797 24 42608510
Viral acanthoma 20.53 19.51 4 12797 25 42608509
Laryngeal discomfort 20.46 19.51 6 12795 240 42608294
Dehydroepiandrosterone decreased 20.39 19.51 4 12797 26 42608508
Condition aggravated 20.38 19.51 141 12660 260613 42347921
Eosinophilic bronchitis 20.22 19.51 6 12795 250 42608284
Bronchial obstruction 20.10 19.51 10 12791 1719 42606815
Hypotension 20.01 19.51 29 12772 257602 42350932
Urine calcium/creatinine ratio increased 19.78 19.51 4 12797 31 42608503
Dermatitis allergic 19.75 19.51 18 12783 8465 42600069

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 685.01 14.29 611 36795 249680 110302213
Wheezing 504.41 14.29 521 36885 254709 110297184
Obstructive airways disorder 487.74 14.29 260 37146 45889 110506004
Full blood count abnormal 363.59 14.29 230 37176 55822 110496071
Therapeutic product effect incomplete 316.54 14.29 384 37022 223421 110328472
Chronic sinusitis 315.76 14.29 159 37247 24925 110526968
Nasal congestion 298.44 14.29 255 37151 98027 110453866
Appendicolith 223.45 14.29 105 37301 14150 110537743
Nasal polyps 212.38 14.29 99 37307 13101 110538792
Macular degeneration 206.38 14.29 114 37292 21545 110530348
Gastrooesophageal reflux disease 187.70 14.29 266 37140 179710 110372183
Chronic obstructive pulmonary disease 180.29 14.29 203 37203 108955 110442938
Cough 179.37 14.29 446 36960 461195 110090698
Throat clearing 175.45 14.29 63 37343 4270 110547623
Sleep disorder due to a general medical condition 174.20 14.29 143 37263 51969 110499924
Paraesthesia oral 171.78 14.29 119 37287 33552 110518341
Appendicitis 158.02 14.29 106 37300 28358 110523535
Dyspnoea 154.50 14.29 760 36646 1106112 109445781
Vaginal flatulence 149.94 14.29 76 37330 12068 110539825
Rhinorrhoea 147.91 14.29 178 37228 102488 110449405
Female genital tract fistula 141.25 14.29 81 37325 16438 110535455
Procedural pain 141.19 14.29 108 37298 35457 110516436
Productive cough 138.88 14.29 182 37224 114123 110437770
Bronchiectasis 138.72 14.29 108 37298 36385 110515508
Stress 137.82 14.29 174 37232 105174 110446719
Proctitis 136.77 14.29 80 37326 16847 110535046
Blood immunoglobulin E increased 132.53 14.29 60 37346 7422 110544471
Sputum discoloured 129.18 14.29 93 37313 27852 110524041
Bronchial neoplasm 128.58 14.29 31 37375 505 110551388
Toxicity to various agents 127.82 14.29 9 37397 480546 110071347
Nasal obstruction 125.53 14.29 46 37360 3304 110548589
Vaginal discharge 124.90 14.29 77 37329 17831 110534062
Nasal turbinate hypertrophy 119.32 14.29 32 37374 812 110551081
Radiculopathy 117.01 14.29 76 37330 19260 110532633
Ventricular fibrillation 116.83 14.29 103 37303 41210 110510683
Endometrial ablation 111.05 14.29 31 37375 917 110550976
Malignant mediastinal neoplasm 103.81 14.29 32 37374 1346 110550547
Bronchial haemorrhage 103.61 14.29 32 37374 1355 110550538
Rhinitis 99.59 14.29 73 37333 22472 110529421
Blood test abnormal 98.86 14.29 80 37326 28474 110523419
Rhonchi 98.72 14.29 42 37364 4476 110547417
Eczema 95.47 14.29 120 37286 72173 110479720
Secretion discharge 95.00 14.29 68 37338 20176 110531717
Oral candidiasis 91.04 14.29 93 37313 44667 110507226
Diabetes mellitus 89.25 14.29 137 37269 99244 110452649
Myasthenia gravis 89.07 14.29 67 37339 21444 110530449
Total lung capacity increased 87.40 14.29 40 37366 5072 110546821
Acute kidney injury 86.69 14.29 54 37352 635376 109916517
Cardiogenic shock 85.15 14.29 101 37305 57237 110494656
Chest discomfort 84.91 14.29 184 37222 173664 110378229
Blood uric acid increased 84.61 14.29 65 37341 21464 110530429
Hyperphosphataemia 83.78 14.29 58 37348 16323 110535570
Hyper IgE syndrome 83.12 14.29 23 37383 658 110551235
Bronchial disorder 81.87 14.29 32 37374 2744 110549149
Respiratory tract infection 79.26 14.29 109 37297 71508 110480385
Blepharospasm 77.16 14.29 94 37312 54757 110497136
Asthma-chronic obstructive pulmonary disease overlap syndrome 76.27 14.29 39 37367 6305 110545588
Injection site scab 75.10 14.29 21 37385 625 110551268
Rhinitis allergic 74.60 14.29 56 37350 17866 110534027
Carbuncle 73.50 14.29 25 37381 1442 110550451
Asthmatic crisis 71.42 14.29 27 37379 2115 110549778
Dyslipidaemia 71.20 14.29 52 37354 15913 110535980
Restrictive pulmonary disease 70.23 14.29 30 37376 3229 110548664
Taste disorder 70.08 14.29 98 37308 65289 110486604
Analgesic therapy 68.45 14.29 38 37368 7246 110544647
Hypothalamo-pituitary disorder 67.34 14.29 28 37378 2818 110549075
Overweight 67.05 14.29 36 37370 6428 110545465
Forced expiratory volume decreased 65.86 14.29 46 37360 13130 110538763
Dyspnoea exertional 64.95 14.29 122 37284 103938 110447955
Sleep disorder therapy 64.85 14.29 37 37369 7434 110544459
Neutropenia 64.61 14.29 23 37383 374597 110177296
Neuralgia 63.24 14.29 80 37326 48398 110503495
Nasal oedema 62.41 14.29 35 37371 6804 110545089
Constipation 61.66 14.29 262 37144 357524 110194369
Thrombocytopenia 60.88 14.29 21 37385 348864 110203029
Monoclonal immunoglobulin present 60.14 14.29 25 37381 2515 110549378
Weight decreased 59.67 14.29 314 37092 467743 110084150
Sensitivity to weather change 59.65 14.29 39 37367 9989 110541904
Iron deficiency 58.18 14.29 49 37357 18427 110533466
Respiratory tract inflammation 57.10 14.29 19 37387 1024 110550869
Blood phosphorus increased 57.02 14.29 46 37360 16294 110535599
Respiratory disorder 55.28 14.29 92 37314 71290 110480603
Hypophosphataemia 55.22 14.29 62 37344 33120 110518773
Sarcoidosis 53.91 14.29 40 37366 12539 110539354
Ascites 53.24 14.29 105 37301 92703 110459190
Sleep apnoea syndrome 53.16 14.29 67 37339 40380 110511513
Drug interaction 52.56 14.29 55 37351 500128 110051765
Drug therapy 52.50 14.29 32 37374 7259 110544634
Seasonal allergy 51.46 14.29 47 37359 19675 110532218
Frequent bowel movements 51.30 14.29 89 37317 71301 110480592
Affective disorder 51.01 14.29 37 37369 11204 110540689
Loss of personal independence in daily activities 50.91 14.29 138 37268 149882 110402011
Dust allergy 50.16 14.29 29 37377 5972 110545921
Epilepsy 48.82 14.29 106 37300 100103 110451790
Febrile neutropenia 47.33 14.29 24 37382 316743 110235150
Bacteroides infection 47.28 14.29 22 37384 2897 110548996
Granuloma 47.12 14.29 33 37373 9457 110542436
SARS-CoV-2 sepsis 46.86 14.29 12 37394 253 110551640
Breath sounds abnormal 46.67 14.29 50 37356 25354 110526539
Abdominal distension 45.05 14.29 146 37260 174957 110376936
Polycystic ovaries 45.01 14.29 25 37381 4771 110547122
Colitis ulcerative 44.95 14.29 88 37318 77275 110474618
Cardiac arrest 43.83 14.29 7 37399 196746 110355147
Lung hyperinflation 43.07 14.29 19 37387 2210 110549683
Cardiac murmur 42.67 14.29 47 37359 24581 110527312
Hypotension 42.33 14.29 70 37336 523779 110028114
Haematochezia 41.96 14.29 109 37297 115415 110436478
Dyspepsia 41.92 14.29 151 37255 190814 110361079
Platelet count decreased 41.72 14.29 13 37393 230430 110321463
Eosinophilic granulomatosis with polyangiitis 41.41 14.29 32 37374 10654 110541239
Diarrhoea 41.32 14.29 222 37184 1139283 109412610
Lung diffusion disorder 40.87 14.29 11 37395 283 110551610
Abdominal pain 40.78 14.29 305 37101 512684 110039209
Migraine 40.49 14.29 139 37267 171513 110380380
Disease progression 40.35 14.29 16 37390 244018 110307875
Death 40.19 14.29 113 37293 698756 109853137
Haemoglobin decreased 40.01 14.29 17 37389 248710 110303183
Sinusitis 39.81 14.29 202 37204 296486 110255407
Wrist deformity 39.48 14.29 20 37386 3169 110548724
Overdose 39.20 14.29 15 37391 233779 110318114
Total lung capacity decreased 38.29 14.29 26 37380 7088 110544805
Inguinal hernia repair 37.99 14.29 11 37395 372 110551521
Bacterial infection 37.89 14.29 61 37345 45975 110505918
Dehydration 37.71 14.29 24 37382 279487 110272406
Respiratory failure 37.48 14.29 13 37393 215319 110336574
Incorrect route of product administration 37.37 14.29 73 37333 63988 110487905
Malignant neoplasm progression 37.16 14.29 7 37399 174560 110377333
Middle insomnia 37.04 14.29 40 37366 20462 110531431
Sleep disorder 36.95 14.29 149 37257 198495 110353398
Lung neoplasm malignant 36.67 14.29 51 37355 33791 110518102
Lactose intolerance 36.10 14.29 18 37388 2758 110549135
Pancytopenia 35.89 14.29 13 37393 209600 110342293
Malaise 35.47 14.29 365 37041 671454 109880439
Haemoptysis 35.35 14.29 76 37330 71278 110480615
Fungal disease carrier 35.27 14.29 11 37395 481 110551412
Lung opacity 34.84 14.29 30 37376 11622 110540271
Gastrointestinal haemorrhage 34.46 14.29 7 37399 165511 110386382
Fibrosis 34.32 14.29 25 37381 7617 110544276
Antacid therapy 34.27 14.29 22 37384 5462 110546431
Septic shock 34.21 14.29 6 37400 157522 110394371
Aortic stenosis 33.83 14.29 31 37375 13028 110538865
Eye pruritus 33.45 14.29 48 37358 32727 110519166
White blood cell count decreased 33.34 14.29 18 37388 229372 110322521
Rectal haemorrhage 32.72 14.29 102 37304 119731 110432162
Anticoagulant therapy 32.26 14.29 21 37385 5340 110546553
Respiratory rate increased 32.09 14.29 41 37365 25042 110526851
Hand deformity 31.97 14.29 17 37389 218489 110333404
Body height decreased 31.19 14.29 27 37379 10536 110541357
Fatigue 30.99 14.29 263 37143 1215695 109336198
Blood pressure systolic increased 30.85 14.29 79 37327 82912 110468981
Treatment failure 30.80 14.29 29 37377 277205 110274688
Rhabdomyolysis 29.92 14.29 3 37403 120398 110431495
Eosinophilic pneumonia chronic 29.73 14.29 10 37396 557 110551336
Bone density decreased 28.46 14.29 31 37375 16011 110535882
Ligament pain 28.36 14.29 8 37398 246 110551647
Helicobacter infection 28.34 14.29 13 37393 181864 110370029
Alopecia 27.39 14.29 51 37355 364702 110187191
Anosmia 27.35 14.29 27 37379 12445 110539448
Coma 26.69 14.29 4 37402 117865 110434028
Polyp 26.46 14.29 24 37382 9956 110541937
Ankle fracture 26.31 14.29 33 37373 19786 110532107
Bronchopulmonary aspergillosis allergic 25.82 14.29 22 37384 8404 110543489
Drug abuse 25.66 14.29 14 37392 177397 110374496
Systemic lupus erythematosus 25.54 14.29 29 37377 254309 110297584
Renal cyst 25.32 14.29 31 37375 18141 110533752
Colitis 25.12 14.29 84 37322 102239 110449654
Dry mouth 24.63 14.29 133 37273 199815 110352078
Suicide attempt 24.62 14.29 3 37403 103391 110448502
Radioallergosorbent test positive 24.45 14.29 5 37401 36 110551857
Decreased appetite 24.42 14.29 81 37325 475765 110076128
Illness 24.35 14.29 72 37334 82099 110469794
Hypokalaemia 24.14 14.29 16 37390 182432 110369461
Nephropathy 23.85 14.29 26 37380 13441 110538452
Paraesthesia 23.41 14.29 167 37239 276354 110275539
Eosinophil count increased 23.21 14.29 32 37374 21026 110530867
Activated partial thromboplastin time prolonged 23.18 14.29 33 37373 22335 110529558
Oropharyngeal candidiasis 23.04 14.29 12 37394 2014 110549879
Asthenia 22.86 14.29 138 37268 688861 109863032
End stage renal disease 22.73 14.29 32 37374 21441 110530452
Tachycardia 22.58 14.29 26 37380 226619 110325274
Cerebrovascular accident 22.54 14.29 17 37389 181267 110370626
Abdominal discomfort 22.36 14.29 64 37342 393794 110158099
Multiple organ dysfunction syndrome 22.25 14.29 106 37300 151604 110400289
Rales 22.04 14.29 34 37372 24705 110527188
Cardio-respiratory arrest 21.94 14.29 6 37400 115830 110436063
Cardiac failure congestive 21.71 14.29 12 37394 150988 110400905
Nasal disorder 21.67 14.29 15 37391 4219 110547674
Confusional state 21.25 14.29 84 37322 468596 110083297
Gastroenteritis eosinophilic 20.92 14.29 7 37399 384 110551509
Allergy to animal 20.80 14.29 11 37395 1905 110549988
Hyperkalaemia 20.70 14.29 10 37396 135786 110416107
Ear pruritus 20.32 14.29 18 37388 7242 110544651
Swelling face 20.24 14.29 73 37333 92248 110459645
Interstitial lung disease 20.14 14.29 11 37395 139323 110412570
Respiratory symptom 20.02 14.29 25 37381 14920 110536973
Neutrophil count decreased 19.87 14.29 8 37398 120933 110430960
Blood pressure diastolic increased 19.86 14.29 28 37378 18779 110533114
Ovarian cyst 19.79 14.29 24 37382 13906 110537987
Joint swelling 19.68 14.29 80 37326 442765 110109128
Drug-induced liver injury 19.63 14.29 8 37398 120059 110431834
Lower respiratory tract infection 19.53 14.29 145 37261 242961 110308932
Alanine aminotransferase increased 19.50 14.29 20 37386 183753 110368140
Movement disorder 19.45 14.29 40 37366 36364 110515529
Fall 19.42 14.29 122 37284 603360 109948533
Gout 19.33 14.29 40 37366 36526 110515367
Seizure 19.33 14.29 28 37378 221157 110330736
Contraindicated product administered 19.27 14.29 34 37372 248233 110303660
Erythema 19.15 14.29 166 37240 291281 110260612
Impaired healing 19.13 14.29 23 37383 196694 110355199
Herpes zoster 19.11 14.29 80 37326 108299 110443594
Bronchitis 19.03 14.29 104 37302 156928 110394965
Medication error 18.96 14.29 6 37400 105360 110446533
Rash 18.92 14.29 182 37224 820782 109731111
Pemphigus 18.91 14.29 27 37379 214543 110337350
Pulmonary mass 18.78 14.29 40 37366 37261 110514632
Pertussis 18.66 14.29 9 37397 1284 110550609
Breast conserving surgery 18.40 14.29 8 37398 899 110550994
Wound 18.29 14.29 32 37374 234405 110317488
Electrocardiogram QT prolonged 18.24 14.29 7 37399 108953 110442940
Mucosal inflammation 18.17 14.29 5 37401 96136 110455757
Eosinophilic bronchitis 18.15 14.29 7 37399 579 110551314
Urinary tract infection 17.81 14.29 54 37352 326228 110225665
Depressed level of consciousness 17.53 14.29 8 37398 112270 110439623
Central obesity 17.45 14.29 10 37396 2026 110549867
Limb injury 17.40 14.29 39 37367 37597 110514296
Eosinophilia 17.39 14.29 51 37355 57885 110494008
Atrial fibrillation 17.33 14.29 32 37374 229610 110322283
Memory impairment 17.28 14.29 120 37286 196824 110355069
Lactic acidosis 17.22 14.29 5 37401 92806 110459087
Anti-cyclic citrullinated peptide antibody positive 16.94 14.29 22 37384 181962 110369931
Therapy non-responder 16.83 14.29 17 37389 157290 110394603
Cortisol decreased 16.80 14.29 11 37395 2825 110549068
Anhidrosis 16.74 14.29 6 37400 404 110551489
Hand fracture 16.74 14.29 17 37389 8105 110543788
Glossodynia 16.69 14.29 31 37375 221973 110329920
Steroid diabetes 16.68 14.29 14 37392 5240 110546653
Hyposmia 16.57 14.29 8 37398 1143 110550750
Atopy 16.55 14.29 8 37398 1146 110550747
Chest pain 16.38 14.29 197 37209 376178 110175715
Inflammation 16.36 14.29 25 37381 193213 110358680
Troponin increased 16.25 14.29 33 37373 29733 110522160
Cardiac failure 16.15 14.29 24 37382 187602 110364291
Discomfort 16.13 14.29 30 37376 214677 110337216
Crepitations 15.94 14.29 19 37387 10816 110541077
Hyponatraemia 15.91 14.29 127 37279 217526 110334367
Pulmonary function test decreased 15.76 14.29 17 37389 8683 110543210
Encephalopathy 15.72 14.29 4 37402 81051 110470842
Frustration tolerance decreased 15.71 14.29 17 37389 8714 110543179
Neck injury 15.69 14.29 11 37395 3157 110548736
Sex hormone binding globulin decreased 15.61 14.29 3 37403 15 110551878
Testicular microlithiasis 15.61 14.29 3 37403 15 110551878
Alpha 2 globulin decreased 15.61 14.29 3 37403 15 110551878
Obstruction 15.58 14.29 14 37392 5738 110546155
Hepatic enzyme increased 15.52 14.29 56 37350 320836 110231057
Free androgen index decreased 15.44 14.29 3 37403 16 110551877
Otosalpingitis 15.44 14.29 3 37403 16 110551877
Androgen insensitivity syndrome 15.44 14.29 3 37403 16 110551877
Fear of crowded places 15.29 14.29 3 37403 17 110551876
Delirium 15.13 14.29 14 37392 135011 110416882
Leukopenia 14.89 14.29 17 37389 148774 110403119
Madarosis 14.81 14.29 11 37395 3452 110548441
Sneezing 14.63 14.29 33 37373 31951 110519942
Blood glucose increased 14.54 14.29 14 37392 132482 110419411
Haemophilus infection 14.52 14.29 10 37396 2790 110549103
Pericarditis 14.44 14.29 33 37373 219081 110332812
Post 5-alpha-reductase inhibitor syndrome 14.34 14.29 4 37402 118 110551775

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 R01AD12 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 R03AK10 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 R03AL08 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03BA05 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Glucocorticoids
ATC R03BA09 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
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D001993 Bronchodilator Agents
MeSH PA D003879 Dermatologic Agents
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D019141 Respiratory System Agents
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:49167 anti-asthmatic drug
CHEBI has role CHEBI:50113 androgen
CHEBI has role CHEBI:50857 anti-allergic agent
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:77715 nasal decongestant

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

DiseaseRelationSNOMED_IDDOID
Chronic obstructive lung disease indication 13645005 DOID:3083
Allergic rhinitis indication 61582004
Chronic bronchitis indication 63480004 DOID:6132
Pulmonary emphysema indication 87433001
Asthma indication 195967001 DOID:2841
Chronic Non-Allergic Rhinitis indication
Mycosis contraindication 3218000 DOID:1564
Ocular hypertension contraindication 4210003 DOID:9282
Epistaxis contraindication 12441001
Measles contraindication 14189004 DOID:8622
Disease caused by parasite contraindication 17322007
Glaucoma contraindication 23986001 DOID:1686
Viral disease contraindication 34014006 DOID:934
Hypercortisolism contraindication 47270006
Perforation of nasal septum contraindication 80142000
Bacterial infectious disease contraindication 87628006
Operation on nose contraindication 88733004
Bilateral cataracts contraindication 95722004
Pulmonary tuberculosis contraindication 154283005 DOID:2957
Ophthalmic herpes simplex contraindication 186542001
Varicella-zoster virus infection contraindication 309465005
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Exposure to varicella contraindication 444453009
Nasal Candidiasis contraindication
Nasal Trauma contraindication
Nasal Septal Ulcers 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
0.05MG/INH;EQ 0.025MG BASE/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 12, 2023 RX POWDER INHALATION 8511304 June 14, 2027 MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS
0.1MG/INH;EQ 0.025MG BASE/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 8511304 June 14, 2027 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.1MG/INH;EQ 0.025MG BASE/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 8511304 June 14, 2027 LONG-TERM, ONCE DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS
0.1MG/INH;EQ 0.025MG BASE/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 8511304 June 14, 2027 MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS
0.2MG/INH;EQ 0.025MG BASE/INH BREO ELLIPTA GLAXO GRP LTD N204275 April 30, 2015 RX POWDER INHALATION 8511304 June 14, 2027 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.2MG/INH;EQ 0.025MG BASE/INH BREO ELLIPTA GLAXO GRP LTD N204275 April 30, 2015 RX POWDER INHALATION 8511304 June 14, 2027 MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS
0.05MG/INH;EQ 0.025MG BASE/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 12, 2023 RX POWDER INHALATION 11116721 Feb. 26, 2029 MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS
0.1MG/INH;EQ 0.025MG BASE/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 11116721 Feb. 26, 2029 INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
0.1MG/INH;EQ 0.025MG BASE/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 11116721 Feb. 26, 2029 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.1MG/INH;EQ 0.025MG BASE/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION 11116721 Feb. 26, 2029 MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS
0.2MG/INH;EQ 0.025MG BASE/INH BREO ELLIPTA GLAXO GRP LTD N204275 April 30, 2015 RX POWDER INHALATION 11116721 Feb. 26, 2029 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
0.2MG/INH;EQ 0.025MG BASE/INH BREO ELLIPTA GLAXO GRP LTD N204275 April 30, 2015 RX POWDER INHALATION 11116721 Feb. 26, 2029 MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH TRELEGY ELLIPTA GLAXOSMITHKLINE N209482 Sept. 18, 2017 RX POWDER INHALATION 11090294 Nov. 29, 2030 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) COMPRISING THE ONCE PER DAY ADMINISTRATION OF TRELEGY ELLIPTA, 100 MCG FLUTICASONE FUROATE/62.5 MCG UMECLIDINIUM/25 MCG VILANTEROL

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.05MG/INH ARNUITY ELLIPTA GLAXOSMITHKLINE N205625 May 17, 2018 RX POWDER INHALATION March 1, 2026 INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HZA114971
0.05MG/INH;EQ 0.025MG BASE/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 12, 2023 RX POWDER INHALATION May 13, 2026 NEW STRENGTH
0.1MG/INH;EQ 0.025MG BASE/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION May 13, 2026 NEW PATIENT POPULATION
0.05MG/INH;EQ 0.025MG BASE/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 12, 2023 RX POWDER INHALATION Nov. 13, 2026 PEDIATRIC EXCLUSIVITY
0.1MG/INH;EQ 0.025MG BASE/INH BREO ELLIPTA GLAXO GRP LTD N204275 May 10, 2013 RX POWDER INHALATION Nov. 13, 2026 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST IC50 10.12 CHEMBL CHEMBL
Mineralocorticoid receptor Nuclear hormone receptor IC50 6.83 CHEMBL
Progesterone receptor Nuclear hormone receptor IC50 7.68 CHEMBL
Androgen receptor Transcription factor IC50 5.73 CHEMBL
Glucocorticoid receptor Transcription factor IC50 8.30 CHEMBL

External reference:

IDSource
D06315 KEGG_DRUG
4026165 VUID
N0000179800 NUI
4020529 VANDF
4026165 VANDF
CHEBI:74899 CHEBI
GW6 PDB_CHEM_ID
CHEMBL1676 ChEMBL_ID
C523187 MESH_SUPPLEMENTAL_RECORD_UI
10892 IUPHAR_LIGAND_ID
8521 INN_ID
DB08906 DRUGBANK_ID
JS86977WNV UNII
DB13867 DRUGBANK_ID
41126 RXNORM
109674 MMSL
23848 MMSL
51966 MMSL
d01296 MMSL
004952 NDDF
012173 NDDF
108632003 SNOMEDCT_US
397192001 SNOMEDCT_US
426409006 SNOMEDCT_US
C1948374 UMLSCUI
C0082607 UMLSCUI
CHEMBL1201396 ChEMBL_ID
9854489 PUBCHEM_CID
90566-53-3 SECONDARY_CAS_RN
5311101 PUBCHEM_CID
6699 IUPHAR_LIGAND_ID
5636 INN_ID
D000068298 MESH_DESCRIPTOR_UI
CUT2W21N7U UNII
CHEBI:5134 CHEBI
JS86977WNV INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
FLONASE SENSIMISTALLERGY RELIEF HUMAN OTC DRUG LABEL 1 0135-0615 SPRAY, METERED 27.50 ug NASAL NDA 17 sections
FLONASE SENSIMISTALLERGY RELIEF HUMAN OTC DRUG LABEL 1 0135-0616 SPRAY, METERED 27.50 ug NASAL NDA 16 sections
Breo Ellipta HUMAN PRESCRIPTION DRUG LABEL 2 0173-0859 POWDER 100 ug RESPIRATORY (INHALATION) NDA 26 sections
Arnuity Ellipta HUMAN PRESCRIPTION DRUG LABEL 1 0173-0874 POWDER 100 ug RESPIRATORY (INHALATION) NDA 27 sections
Arnuity Ellipta HUMAN PRESCRIPTION DRUG LABEL 1 0173-0876 POWDER 200 ug RESPIRATORY (INHALATION) NDA 27 sections
Breo Ellipta HUMAN PRESCRIPTION DRUG LABEL 2 0173-0882 POWDER 200 ug RESPIRATORY (INHALATION) NDA 26 sections
Trelegy Ellipta HUMAN PRESCRIPTION DRUG LABEL 3 0173-0887 POWDER 100 ug RESPIRATORY (INHALATION) NDA 26 sections
Arnuity Ellipta HUMAN PRESCRIPTION DRUG LABEL 1 0173-0888 POWDER 50 ug RESPIRATORY (INHALATION) NDA 27 sections
Trelegy Ellipta HUMAN PRESCRIPTION DRUG LABEL 3 0173-0893 POWDER 200 ug RESPIRATORY (INHALATION) NDA 26 sections
Breo Ellipta HUMAN PRESCRIPTION DRUG LABEL 2 0173-0916 POWDER 50 ug RESPIRATORY (INHALATION) NDA 26 sections
FLONASE SENSIMISTALLERGY RELIEF HUMAN OTC DRUG LABEL 1 50090-5967 SPRAY, METERED 27.50 ug NASAL NDA 17 sections
FLONASE SENSIMISTALLERGY RELIEF HUMAN OTC DRUG LABEL 1 50090-6075 SPRAY, METERED 27.50 ug NASAL NDA 17 sections
Veramyst HUMAN PRESCRIPTION DRUG LABEL 1 54868-6168 SPRAY, METERED 27.50 ug NASAL NDA 27 sections
Fluticasone Furoate and Vilanterol HUMAN PRESCRIPTION DRUG LABEL 2 66993-135 POWDER 100 ug RESPIRATORY (INHALATION) NDA authorized generic 26 sections
Fluticasone Furoate and Vilanterol HUMAN PRESCRIPTION DRUG LABEL 2 66993-136 POWDER 200 ug RESPIRATORY (INHALATION) NDA authorized generic 26 sections
Fluticasone Furoate Ellipta HUMAN PRESCRIPTION DRUG LABEL 1 66993-166 POWDER 50 ug RESPIRATORY (INHALATION) NDA authorized generic 27 sections
Fluticasone Furoate Ellipta HUMAN PRESCRIPTION DRUG LABEL 1 66993-167 POWDER 100 ug RESPIRATORY (INHALATION) NDA authorized generic 27 sections
Fluticasone Furoate Ellipta HUMAN PRESCRIPTION DRUG LABEL 1 66993-168 POWDER 200 ug RESPIRATORY (INHALATION) NDA authorized generic 27 sections