fluticasone propionate 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: 3.80
  • 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 ┬ÁM/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

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 2733.84 9.84 2530 184654 89012 46409866
Wheezing 772.77 9.84 1010 186174 52376 46446502
Dyspnoea 591.40 9.84 3804 183380 511744 45987134
Chronic obstructive pulmonary disease 543.74 9.84 891 186293 56742 46442136
Completed suicide 527.29 9.84 12 187172 145908 46352970
Cough 411.06 9.84 1919 185265 228330 46270548
Toxicity to various agents 394.17 9.84 178 187006 211588 46287290
Obstructive airways disorder 335.48 9.84 337 186847 13075 46485803
Sinusitis 297.93 9.84 1168 186016 128600 46370278
Productive cough 288.53 9.84 632 186552 50083 46448795
Forced expiratory volume decreased 285.64 9.84 204 186980 4900 46493978
Infective pulmonary exacerbation of cystic fibrosis 278.51 9.84 276 186908 10531 46488347
Bronchitis 254.70 9.84 968 186216 105011 46393867
Sputum discoloured 250.34 9.84 282 186902 12496 46486382
Chest discomfort 245.18 9.84 858 186326 89411 46409467
Pneumonia 218.84 9.84 2387 184797 373933 46124945
Product quality issue 207.00 9.84 448 186736 35200 46463678
Eosinophilic granulomatosis with polyangiitis 184.11 9.84 106 187078 1730 46497148
Drug abuse 178.54 9.84 22 187162 63386 46435492
Neutropenia 176.67 9.84 188 186996 143016 46355862
Synovitis 170.00 9.84 22 187162 61053 46437825
Upper respiratory tract infection 169.82 9.84 601 186583 62955 46435923
Nasal congestion 161.79 9.84 492 186692 47621 46451257
Intentional overdose 151.33 9.84 37 187147 64907 46433971
Rheumatoid arthritis 146.01 9.84 485 186699 239730 46259148
Febrile neutropenia 142.31 9.84 103 187081 94524 46404354
Off label use 136.69 9.84 927 186257 378914 46119964
Treatment failure 136.53 9.84 104 187080 92983 46405895
Blood count abnormal 131.58 9.84 248 186936 17630 46481248
Thrombocytopenia 124.35 9.84 197 186987 126384 46372494
Nasal polyps 122.90 9.84 88 187096 2122 46496756
Food allergy 119.05 9.84 143 187041 6790 46492088
Temperature regulation disorder 117.98 9.84 102 187082 3258 46495620
Pancytopenia 114.87 9.84 103 187081 84955 46413923
Contraindicated product administered 110.14 9.84 95 187089 79852 46419026
Pulmonary function test decreased 106.74 9.84 102 187082 3718 46495160
Systemic lupus erythematosus 106.00 9.84 65 187119 65115 46433763
Drug ineffective 105.21 9.84 2002 185182 675836 45823042
Dyspnoea exertional 99.72 9.84 433 186751 49856 46449022
Influenza 98.99 9.84 655 186529 88615 46410263
Dysphonia 98.09 9.84 358 186826 38056 46460822
Drug intolerance 96.21 9.84 287 186897 146762 46352116
Hand deformity 94.90 9.84 13 187171 34561 46464317
Malignant neoplasm progression 94.60 9.84 73 187111 64853 46434025
Seasonal allergy 89.61 9.84 178 187006 13156 46485722
Coeliac disease 87.61 9.84 125 187059 7036 46491842
Middle insomnia 86.79 9.84 145 187039 9370 46489508
Coma 85.78 9.84 65 187119 58284 46440594
Rhinitis allergic 85.13 9.84 121 187063 6787 46492091
Cardio-respiratory arrest 85.10 9.84 69 187115 59800 46439078
Leukopenia 85.02 9.84 89 187095 68254 46430624
Death 82.86 9.84 903 186281 334645 46164233
Drug interaction 81.96 9.84 478 186706 202616 46296262
Respiratory tract congestion 79.37 9.84 165 187019 12599 46486279
Adrenal suppression 77.39 9.84 48 187136 903 46497975
Rhinorrhoea 74.47 9.84 383 186801 47282 46451596
Maternal exposure during pregnancy 73.85 9.84 191 186993 102358 46396520
Fluid retention 73.48 9.84 401 186783 50645 46448233
Hypersensitivity 73.37 9.84 923 186261 149398 46349480
Anaemia 73.25 9.84 664 186520 255115 46243763
Blood immunoglobulin E increased 72.97 9.84 59 187125 1714 46497164
Oropharyngeal pain 72.07 9.84 527 186657 73641 46425237
Immunodeficiency 71.85 9.84 161 187023 12945 46485933
Breath sounds abnormal 71.15 9.84 119 187065 7696 46491182
Joint swelling 70.70 9.84 384 186800 165689 46333189
Multiple organ dysfunction syndrome 70.54 9.84 62 187122 51648 46447230
Alopecia 69.99 9.84 374 186810 162040 46336838
Cystic fibrosis 68.18 9.84 79 187105 3609 46495269
Sleep apnoea syndrome 67.22 9.84 219 186965 21982 46476896
Sputum increased 67.17 9.84 56 187128 1700 46497178
Hepatic function abnormal 66.99 9.84 27 187157 34394 46464484
Sleep disorder due to a general medical condition 66.45 9.84 76 187108 3423 46495455
Product dose omission issue 66.05 9.84 995 186189 167525 46331353
Glossodynia 65.77 9.84 49 187135 44324 46454554
Hepatotoxicity 64.98 9.84 11 187173 24998 46473880
Drug reaction with eosinophilia and systemic symptoms 64.72 9.84 19 187165 29529 46469349
Emphysema 64.65 9.84 124 187060 8930 46489948
Acute kidney injury 64.62 9.84 619 186565 235236 46263642
Peak expiratory flow rate decreased 64.58 9.84 37 187147 598 46498280
Gastrooesophageal reflux disease 63.18 9.84 512 186672 73832 46425046
Mucosal inflammation 63.18 9.84 39 187145 38937 46459941
Malaise 61.36 9.84 1750 185434 329482 46169396
Nasopharyngitis 60.23 9.84 909 186275 153089 46345789
Upper-airway cough syndrome 59.17 9.84 110 187074 7737 46491141
Suicide attempt 57.54 9.84 82 187102 54954 46443924
Overdose 57.08 9.84 213 186971 101766 46397112
Gamma-glutamyltransferase increased 56.89 9.84 28 187156 31712 46467166
Eosinophil count increased 56.50 9.84 108 187076 7758 46491120
Therapeutic product effect decreased 56.33 9.84 158 187026 82443 46416435
Platelet count decreased 55.93 9.84 209 186975 99815 46399063
Headache 55.57 9.84 2395 184789 475957 46022921
Respiratory symptom 55.44 9.84 54 187130 2016 46496862
Cardiac arrest 54.47 9.84 183 187001 90216 46408662
Asthmatic crisis 54.20 9.84 46 187138 1432 46497446
Arthropathy 54.15 9.84 167 187017 84533 46414345
Adrenal insufficiency 53.61 9.84 144 187040 12980 46485898
Chronic sinusitis 53.16 9.84 82 187102 4951 46493927
Exposure during pregnancy 52.46 9.84 239 186945 107973 46390905
Bone marrow failure 51.94 9.84 27 187157 29642 46469236
Eye pruritus 51.09 9.84 133 187051 11765 46487113
Inhalation therapy 49.90 9.84 16 187168 50 46498828
Bursitis 49.03 9.84 183 187001 19659 46479219
Haemoptysis 48.50 9.84 221 186963 25968 46472910
Sinus disorder 47.13 9.84 160 187024 16403 46482475
Sopor 46.76 9.84 11 187173 19817 46479061
Oxygen saturation decreased 46.71 9.84 453 186731 68711 46430167
Prolonged expiration 46.35 9.84 25 187159 357 46498521
Sneezing 46.33 9.84 134 187050 12607 46486271
Respiratory arrest 45.57 9.84 41 187143 33775 46465103
Rhinitis 45.46 9.84 99 187085 7807 46491071
C-reactive protein increased 45.41 9.84 105 187079 58485 46440393
Cytomegalovirus infection 44.95 9.84 9 187175 18135 46480743
Acute respiratory failure 44.71 9.84 233 186951 28905 46469973
Lung disorder 44.54 9.84 312 186872 42992 46455886
Hypotension 43.91 9.84 662 186522 231927 46266951
Agranulocytosis 43.83 9.84 17 187167 22168 46476710
Viral infection 43.82 9.84 238 186946 29997 46468881
Forced vital capacity decreased 43.42 9.84 33 187151 874 46498004
Heart rate increased 42.52 9.84 473 186711 74318 46424560
Nasal discomfort 42.46 9.84 63 187121 3675 46495203
Neutrophil count decreased 42.21 9.84 68 187116 43358 46455520
Pulmonary mass 41.90 9.84 162 187022 17695 46481183
Serotonin syndrome 41.00 9.84 23 187161 24197 46474681
Respiratory tract infection 40.16 9.84 231 186953 29741 46469137
Pericarditis 40.10 9.84 23 187161 23904 46474974
Infusion related reaction 39.81 9.84 240 186944 100968 46397910
Dizziness 39.78 9.84 1706 185478 338708 46160170
Alanine aminotransferase increased 39.57 9.84 201 186983 88250 46410628
General physical health deterioration 38.79 9.84 288 186896 115481 46383397
Bradycardia 38.72 9.84 136 187048 66162 46432716
Hyperkalaemia 38.39 9.84 92 187092 50617 46448261
Foetal exposure during pregnancy 38.27 9.84 40 187144 30707 46468171
Lactic acidosis 38.00 9.84 48 187136 33861 46465017
Toxic epidermal necrolysis 37.93 9.84 21 187163 22257 46476621
Aphonia 37.44 9.84 92 187092 7853 46491025
Bronchial wall thickening 37.08 9.84 29 187155 802 46498076
Lower respiratory tract infection 36.79 9.84 360 186824 54729 46444149
Chest pain 36.65 9.84 946 186238 175378 46323500
Osteonecrosis of jaw 36.21 9.84 51 187133 34351 46464527
Renal impairment 36.19 9.84 164 187020 74208 46424670
Metabolic acidosis 35.59 9.84 63 187121 38717 46460161
Renal failure 35.53 9.84 288 186896 113306 46385572
Hypoventilation 35.32 9.84 61 187123 4049 46494829
Hepatocellular injury 34.99 9.84 40 187144 29482 46469396
Anxiety 34.89 9.84 966 186218 180991 46317887
Increased viscosity of bronchial secretion 34.70 9.84 19 187165 280 46498598
Aspartate aminotransferase increased 34.55 9.84 180 187004 78520 46420358
Poisoning 34.55 9.84 7 187177 13987 46484891
Therapeutic product effect incomplete 33.96 9.84 470 186714 77683 46421195
Throat irritation 33.80 9.84 215 186969 28686 46470192
Septic shock 33.65 9.84 119 187065 57774 46441104
Secretion discharge 33.56 9.84 97 187087 9122 46489756
Peritonitis 33.19 9.84 21 187163 20693 46478185
Asthma-chronic obstructive pulmonary disease overlap syndrome 33.15 9.84 22 187162 467 46498411
Pneumocystis jirovecii pneumonia 33.04 9.84 10 187174 15238 46483640
Intentional self-injury 32.92 9.84 29 187155 24137 46474741
Bronchial obstruction 32.65 9.84 33 187151 1289 46497589
Bronchiectasis 31.98 9.84 96 187088 9220 46489658
Feeling abnormal 31.80 9.84 690 186494 124370 46374508
Increased upper airway secretion 31.52 9.84 51 187133 3208 46495670
Product use in unapproved indication 31.48 9.84 222 186962 90051 46408827
Eosinophil count abnormal 31.47 9.84 21 187163 450 46498428
Pulmonary function test abnormal 31.39 9.84 32 187152 1263 46497615
Blood lactate dehydrogenase increased 31.21 9.84 22 187162 20478 46478400
Depressed level of consciousness 30.95 9.84 93 187091 47476 46451402
Premature baby 30.94 9.84 17 187167 18095 46480783
Sinus congestion 30.82 9.84 119 187065 12990 46485888
Ear infection 30.59 9.84 177 187007 22836 46476042
Bronchospasm 30.17 9.84 134 187050 15573 46483305
Blood creatinine increased 30.14 9.84 181 187003 76222 46422656
Cushing's syndrome 30.07 9.84 25 187159 756 46498122
Status asthmaticus 30.03 9.84 27 187157 909 46497969
Palmar-plantar erythrodysaesthesia syndrome 29.77 9.84 23 187161 20428 46478450
Neurotoxicity 29.71 9.84 9 187175 13708 46485170
Hyponatraemia 29.40 9.84 262 186922 101070 46397808
Otorrhoea 29.13 9.84 32 187152 1378 46497500
Aspirin-exacerbated respiratory disease 28.91 9.84 24 187160 724 46498154
Rash erythematous 28.86 9.84 236 186948 34114 46464764
Smoke sensitivity 28.51 9.84 16 187168 248 46498630
Bone erosion 28.45 9.84 93 187091 9350 46489528
Cor pulmonale 28.44 9.84 37 187147 1906 46496972
Drug hypersensitivity 28.44 9.84 752 186432 243073 46255805
Wound 28.34 9.84 83 187101 42719 46456159
Reversible airways obstruction 28.33 9.84 21 187163 535 46498343
Musculoskeletal stiffness 28.15 9.84 254 186930 97739 46401139
Weight increased 27.91 9.84 860 186324 163613 46335265
Posterior reversible encephalopathy syndrome 27.68 9.84 13 187171 15128 46483750
Shock 27.66 9.84 28 187156 21817 46477061
Infusion site erythema 27.42 9.84 80 187104 7562 46491316
Disease progression 27.40 9.84 234 186950 91066 46407812
Rales 27.37 9.84 93 187091 9538 46489340
Palpitations 27.30 9.84 535 186649 94724 46404154
Hospitalisation 27.05 9.84 380 186804 63005 46435873
Spirometry abnormal 26.84 9.84 14 187170 186 46498692
Throat clearing 26.49 9.84 18 187166 398 46498480
Urticaria 26.40 9.84 639 186545 117253 46381625
Cholestasis 26.24 9.84 42 187142 26851 46472027
Eosinophilic oesophagitis 26.14 9.84 14 187170 197 46498681
Rhonchi 26.12 9.84 38 187146 2177 46496701
Bronchial disorder 25.86 9.84 26 187158 1009 46497869
Hepatic failure 25.79 9.84 60 187124 33356 46465522
Cortisol decreased 25.67 9.84 26 187158 1018 46497860
Ectropion 25.58 9.84 13 187171 163 46498715
Asphyxia 25.44 9.84 62 187122 5264 46493614
Product complaint 25.37 9.84 106 187078 11995 46486883
Paranasal sinus discomfort 25.20 9.84 41 187143 2591 46496287
Altered state of consciousness 25.19 9.84 34 187150 23314 46475564
Rhabdomyolysis 25.12 9.84 85 187099 41824 46457054
Circulatory collapse 24.87 9.84 30 187154 21594 46477284
Acute generalised exanthematous pustulosis 24.74 9.84 4 187180 9401 46489477
Rectal prolapse 24.72 9.84 31 187153 1539 46497339
Anosmia 24.54 9.84 51 187133 3893 46494985
Abortion spontaneous 24.51 9.84 91 187093 43555 46455323
Migraine 24.19 9.84 405 186779 69621 46429257
Mite allergy 23.95 9.84 17 187167 404 46498474
Sinus headache 23.84 9.84 56 187128 4644 46494234
Dermatitis allergic 23.82 9.84 107 187077 12496 46486382
Metastases to liver 23.79 9.84 26 187158 19559 46479319
Metastases to bone 23.77 9.84 21 187163 17455 46481423
Respiratory disorder 23.71 9.84 189 186995 27111 46471767
Cardiac failure 23.50 9.84 206 186978 79742 46419136
Drug resistance 23.47 9.84 21 187163 17347 46481531
Acute sinusitis 23.35 9.84 50 187134 3897 46494981
Device expulsion 23.29 9.84 47 187137 27495 46471383
Humidity intolerance 23.00 9.84 16 187168 368 46498510
Jaundice 22.91 9.84 51 187133 28794 46470084
Total lung capacity abnormal 22.87 9.84 8 187176 35 46498843
Dust allergy 22.65 9.84 18 187166 510 46498368
Acute myeloid leukaemia 22.64 9.84 18 187166 15760 46483118
Pneumonia aspiration 22.63 9.84 59 187125 31546 46467332
Multiple allergies 22.57 9.84 73 187111 7298 46491580
Increased bronchial secretion 22.49 9.84 30 187154 1584 46497294
Pruritus 22.19 9.84 1186 185998 241166 46257712
Stevens-Johnson syndrome 22.15 9.84 37 187147 23260 46475618
Drug eruption 22.07 9.84 32 187152 21297 46477581
Lower respiratory tract congestion 22.05 9.84 32 187152 1829 46497049
Seizure 21.91 9.84 354 186830 122700 46376178
Sinusitis fungal 21.84 9.84 22 187162 856 46498022
Atopy 21.79 9.84 12 187172 179 46498699
Pulmonary pain 21.61 9.84 30 187154 1646 46497232
Sputum retention 21.57 9.84 16 187168 408 46498470
Lung hyperinflation 21.54 9.84 25 187159 1144 46497734
Hypothermia 21.45 9.84 11 187173 12172 46486706
Laryngitis 21.43 9.84 84 187100 9232 46489646
Transplant rejection 21.33 9.84 6 187178 9590 46489288
Respiratory tract irritation 21.17 9.84 16 187168 420 46498458
Perfume sensitivity 21.06 9.84 18 187166 566 46498312
Bronchopulmonary aspergillosis allergic 20.99 9.84 20 187164 726 46498152
Injury 20.87 9.84 269 186915 43758 46455120
Muscle rigidity 20.75 9.84 7 187177 9954 46488924
Dyskinesia 20.71 9.84 54 187130 28871 46470007
Eosinophilic pneumonia chronic 20.70 9.84 9 187175 77 46498801
Salpingo-oophorectomy unilateral 20.69 9.84 15 187169 369 46498509
Emotional distress 20.66 9.84 201 186983 30506 46468372
Sepsis 20.50 9.84 403 186781 135611 46363267
Illness 20.33 9.84 100 187084 12124 46486754
Nasal mucosal disorder 20.21 9.84 15 187169 383 46498495
Disseminated intravascular coagulation 20.17 9.84 28 187156 18977 46479901
Anaphylactic reaction 20.14 9.84 312 186872 52800 46446078
Hyposmia 20.07 9.84 15 187169 387 46498491
Helicobacter infection 20.07 9.84 11 187173 11725 46487153
Weight decreased 19.93 9.84 1035 186149 209814 46289064
Bronchitis bacterial 19.87 9.84 19 187165 693 46498185
Pre-existing condition improved 19.81 9.84 65 187119 6547 46492331
Neoplasm progression 19.73 9.84 49 187135 26634 46472244
Liver injury 19.71 9.84 21 187163 15980 46482898
Accidental exposure to product 19.57 9.84 34 187150 21047 46477831
Cerebral haemorrhage 19.53 9.84 54 187130 28317 46470561
Rheumatoid nodule 19.39 9.84 6 187178 9014 46489864
Nocturnal dyspnoea 19.27 9.84 22 187162 989 46497889
Nasal turbinate hypertrophy 19.21 9.84 15 187169 414 46498464
Influenza B virus test positive 19.05 9.84 14 187170 352 46498526
Oral candidiasis 19.02 9.84 128 187056 17404 46481474
Poor quality device used 19.01 9.84 32 187152 2080 46496798
Bronchospasm paradoxical 18.90 9.84 9 187175 97 46498781
Cerebral infarction 18.81 9.84 41 187143 23325 46475553
Bladder prolapse 18.81 9.84 30 187154 1864 46497014
Influenza like illness 18.81 9.84 330 186854 57240 46441638
Neurosensory hypoacusis 18.80 9.84 13 187171 296 46498582
Haemodynamic instability 18.79 9.84 4 187180 7721 46491157
Candida infection 18.79 9.84 153 187031 22087 46476791
Blood bilirubin increased 18.72 9.84 72 187112 34112 46464766
Blood pressure systolic increased 18.67 9.84 187 186997 28600 46470278
Respiratory rate increased 18.64 9.84 93 187091 11340 46487538
White blood cell count decreased 18.63 9.84 327 186857 111904 46386974
Throat tightness 18.53 9.84 144 187040 20495 46478383
Concussion 18.49 9.84 66 187118 6937 46491941
Agitation 18.48 9.84 138 187046 55277 46443601
Back pain 18.25 9.84 1023 186161 209016 46289862
Neuroleptic malignant syndrome 18.20 9.84 11 187173 11111 46487767
Eye infection bacterial 18.06 9.84 9 187175 108 46498770
Distal intestinal obstruction syndrome 18.03 9.84 14 187170 383 46498495
Proteinuria 17.96 9.84 24 187160 16529 46482349
Infusion site swelling 17.96 9.84 57 187127 5642 46493236
Toxic skin eruption 17.94 9.84 14 187170 12373 46486505
Lymphopenia 17.82 9.84 21 187163 15272 46483606
Thyroid atrophy 17.78 9.84 6 187178 23 46498855
Pregnancy 17.69 9.84 53 187131 27084 46471794
Total lung capacity decreased 17.62 9.84 22 187162 1087 46497791
Conjunctivitis allergic 17.60 9.84 18 187166 713 46498165
Encephalopathy 17.60 9.84 72 187112 33517 46465361
Expiratory reserve volume decreased 17.55 9.84 7 187177 47 46498831
Bronchial haemorrhage 17.51 9.84 13 187171 332 46498546
Vomiting 17.41 9.84 1571 185613 451223 46047655
Nasal discharge discolouration 17.31 9.84 25 187159 1423 46497455
Extrapyramidal disorder 17.27 9.84 12 187172 11256 46487622
Haemolytic anaemia 17.16 9.84 9 187175 9833 46489045
Immune-mediated pancreatitis 16.95 9.84 7 187177 52 46498826
Subarachnoid haemorrhage 16.94 9.84 12 187172 11141 46487737
Drug-induced liver injury 16.93 9.84 49 187135 25319 46473559
Metastases to lung 16.92 9.84 11 187173 10685 46488193
Nasal obstruction 16.84 9.84 17 187167 663 46498215
Myelodysplastic syndrome 16.82 9.84 23 187161 15688 46483190
Aplastic anaemia 16.80 9.84 4 187180 7149 46491729
Nasal oedema 16.66 9.84 19 187165 853 46498025
Expired product administered 16.60 9.84 55 187129 5567 46493311
Cardiogenic shock 16.54 9.84 25 187159 16359 46482519
Tubulointerstitial nephritis 16.50 9.84 21 187163 14767 46484111
Mydriasis 16.50 9.84 11 187173 10542 46488336
Anuria 16.45 9.84 13 187171 11418 46487460
Ascites 16.43 9.84 83 187101 36501 46462377
Haematuria 16.42 9.84 54 187130 26804 46472074
Bronchial neoplasm 16.39 9.84 11 187173 238 46498640
Hereditary angioedema 16.32 9.84 54 187130 5462 46493416
Sensitivity to weather change 16.32 9.84 54 187130 5462 46493416
Cholecystitis chronic 16.13 9.84 84 187100 10415 46488463
Premature labour 16.08 9.84 13 187171 11286 46487592
Hypokalaemia 16.07 9.84 252 186932 87772 46411106
Drug level increased 16.00 9.84 31 187153 18410 46480468
Parkinsonism 15.85 9.84 6 187178 7942 46490936
Decreased bronchial secretion 15.80 9.84 7 187177 63 46498815
Inappropriate antidiuretic hormone secretion 15.76 9.84 20 187164 14082 46484796
Lung diffusion test decreased 15.68 9.84 16 187168 632 46498246
Cushingoid 15.65 9.84 58 187126 6208 46492670
Rash 15.64 9.84 1224 185960 355288 46143590
Psychotic disorder 15.61 9.84 43 187141 22578 46476300
Sputum purulent 15.47 9.84 18 187166 826 46498052
Bronchial secretion retention 15.46 9.84 19 187165 924 46497954
Interstitial lung disease 15.41 9.84 140 187044 53809 46445069
Oliguria 15.29 9.84 8 187176 8751 46490127
Arteriosclerosis coronary artery 15.23 9.84 69 187115 8087 46490791
Haemoglobin decreased 15.19 9.84 397 186787 128552 46370326
Administration site erythema 15.16 9.84 15 187169 571 46498307
Myelosuppression 15.06 9.84 6 187178 7697 46491181
Lipohypertrophy 15.05 9.84 17 187167 755 46498123
Infective exacerbation of chronic obstructive airways disease 15.03 9.84 21 187163 1159 46497719
Total lung capacity increased 15.02 9.84 17 187167 757 46498121
Lung neoplasm malignant 15.00 9.84 110 187074 15379 46483499
Respiration abnormal 14.97 9.84 46 187138 4475 46494403
Generalised tonic-clonic seizure 14.93 9.84 57 187127 27065 46471813
Fracture 14.89 9.84 27 187157 16444 46482434
Acute respiratory distress syndrome 14.88 9.84 42 187142 21880 46476998
Ear discomfort 14.78 9.84 60 187124 6701 46492177
Diverticulum 14.77 9.84 86 187098 11120 46487758
Dystonia 14.75 9.84 14 187170 11243 46487635
Cystic fibrosis related diabetes 14.71 9.84 6 187178 43 46498835
Perineal fistula 14.71 9.84 6 187178 43 46498835
Polyneuropathy 14.66 9.84 15 187169 11629 46487249
Limb injury 14.66 9.84 129 187055 19045 46479833
Infusion site haemorrhage 14.58 9.84 29 187155 2145 46496733
Stillbirth 14.54 9.84 4 187180 6487 46492391
Eosinophilic bronchitis 14.48 9.84 11 187173 291 46498587
Infusion site pruritus 14.43 9.84 36 187148 3102 46495776
Multiple drug therapy 14.36 9.84 18 187166 893 46497985
Hypercapnia 14.33 9.84 46 187138 4580 46494298
Epilepsy 14.32 9.84 48 187136 23690 46475188
Neutropenic sepsis 14.28 9.84 17 187167 12307 46486571
Infusion site pain 14.27 9.84 79 187105 10028 46488850
Fluid overload 14.13 9.84 169 187015 27016 46471862
Functional residual capacity increased 14.12 9.84 7 187177 83 46498795
Cystic fibrosis lung 14.09 9.84 8 187176 127 46498751
Febrile bone marrow aplasia 13.99 9.84 5 187179 6857 46492021
Sarcoidosis 13.95 9.84 49 187135 5110 46493768
Oesophageal spasm 13.90 9.84 27 187157 1962 46496916
Heart sounds 13.90 9.84 10 187174 243 46498635
Chronic respiratory failure 13.84 9.84 25 187159 1719 46497159
Rash maculo-papular 13.83 9.84 61 187123 27813 46471065
Plasma cell myeloma 13.79 9.84 113 187071 44365 46454513
Product use issue 13.78 9.84 282 186902 94362 46404516
Administration site swelling 13.76 9.84 20 187164 1145 46497733
Growth failure 13.74 9.84 11 187173 315 46498563
Growth retardation 13.69 9.84 18 187166 937 46497941
Brain oedema 13.63 9.84 18 187166 12460 46486418
Fatigue 13.62 9.84 2701 184483 605996 45892882
Burning sensation 13.60 9.84 252 186932 44159 46454719
Stress 13.59 9.84 286 186898 51265 46447613
Bronchiolitis 13.58 9.84 29 187155 2256 46496622
Metastases to central nervous system 13.52 9.84 15 187169 11206 46487672
Bronchitis chronic 13.43 9.84 42 187142 4125 46494753
Mobility decreased 13.36 9.84 167 187017 60427 46438451
Femoral neck fracture 13.28 9.84 8 187176 8095 46490783
Forced expiratory flow decreased 13.26 9.84 6 187178 57 46498821
Oropharyngitis fungal 13.17 9.84 6 187178 58 46498820
Magnetic resonance imaging thoracic abnormal 13.15 9.84 5 187179 29 46498849
Peripheral sensory neuropathy 13.14 9.84 5 187179 6598 46492280
Premature delivery 13.06 9.84 45 187139 22024 46476854
Nasal dryness 12.91 9.84 37 187147 3463 46495415
Embolism venous 12.86 9.84 30 187154 2477 46496401
Ulcer 12.81 9.84 32 187152 17360 46481518
Torsade de pointes 12.81 9.84 18 187166 12136 46486742
Nephropathy toxic 12.73 9.84 7 187177 7447 46491431
Allergy to animal 12.72 9.84 14 187170 604 46498274
Hepatic enzyme increased 12.72 9.84 241 186943 81546 46417332
Ear pain 12.67 9.84 140 187044 21952 46476926
Restlessness 12.58 9.84 56 187128 25468 46473410
Acute hepatic failure 12.55 9.84 25 187159 14696 46484182
Fracture displacement 12.48 9.84 20 187164 1248 46497630
Body mass index increased 12.44 9.84 18 187166 1026 46497852
Central obesity 12.35 9.84 16 187168 821 46498057
Nasal pruritus 12.24 9.84 10 187174 295 46498583
Transferrin saturation decreased 12.23 9.84 12 187172 452 46498426
Cystic fibrosis respiratory infection suppression 12.17 9.84 12 187172 455 46498423
Epstein-Barr virus infection 12.13 9.84 6 187178 6778 46492100
Red blood cell sedimentation rate increased 12.03 9.84 49 187135 22840 46476038
Impaired healing 12.01 9.84 92 187092 36651 46462227
Functional residual capacity decreased 11.97 9.84 6 187178 73 46498805
Contusion 11.92 9.84 446 186738 87041 46411837
Peak expiratory flow rate abnormal 11.91 9.84 7 187177 119 46498759
Hypoxia 11.90 9.84 282 186902 51556 46447322
Symptom recurrence 11.88 9.84 11 187173 385 46498493
Hyperhidrosis 11.86 9.84 454 186730 88854 46410024
Tobacco abuse 11.83 9.84 14 187170 654 46498224
Blood creatine phosphokinase increased 11.83 9.84 64 187120 27660 46471218
Secondary adrenocortical insufficiency 11.79 9.84 16 187168 859 46498019
Gammopathy 11.75 9.84 7 187177 122 46498756
Muscle spasms 11.75 9.84 605 186579 122508 46376370
Nasal mucosal discolouration 11.72 9.84 4 187180 16 46498862
Hyperthermia 11.68 9.84 9 187175 8005 46490873
Infusion site nodule 11.65 9.84 17 187167 977 46497901
Restrictive pulmonary disease 11.61 9.84 19 187165 1207 46497671
Small airways disease 11.53 9.84 4 187180 17 46498861
Ear canal erythema 11.50 9.84 3 187181 3 46498875
Vocal cord atrophy 11.50 9.84 3 187181 3 46498875
Cardiovascular deconditioning 11.50 9.84 3 187181 3 46498875
Fungal endocarditis 11.47 9.84 9 187175 250 46498628
Sedation 11.45 9.84 50 187134 22860 46476018
Hiatus hernia 11.44 9.84 118 187066 18184 46480694
Gluten sensitivity 11.44 9.84 12 187172 490 46498388
Physiotherapy 11.38 9.84 5 187179 44 46498834
Trifascicular block 11.37 9.84 7 187177 130 46498748
Laryngitis viral 11.35 9.84 4 187180 18 46498860
Vocal cord disorder 11.24 9.84 19 187165 1239 46497639
Blood test abnormal 11.24 9.84 71 187113 9449 46489429
Dermatitis atopic 11.23 9.84 21 187163 1483 46497395
Bronchial irritation 11.17 9.84 4 187180 19 46498859
Accidental overdose 11.16 9.84 42 187142 20024 46478854
Exercise tolerance decreased 11.13 9.84 42 187142 4535 46494343
Retching 11.12 9.84 90 187094 12967 46485911
Hypercalcaemia 11.10 9.84 45 187139 21001 46477877
Electrocardiogram QRS complex prolonged 11.06 9.84 4 187180 5445 46493433
Shock haemorrhagic 10.98 9.84 11 187173 8613 46490265
Insomnia 10.96 9.84 785 186399 164139 46334739
Foot deformity 10.89 9.84 29 187155 15396 46483482
Hypoglycaemia 10.81 9.84 153 187031 54196 46444682
Hypocalcaemia 10.80 9.84 63 187121 26722 46472156
Injection site inflammation 10.68 9.84 32 187152 3070 46495808
Eczema 10.68 9.84 127 187057 20273 46478605
Infusion site urticaria 10.61 9.84 14 187170 731 46498147
Sinus operation 10.48 9.84 20 187164 1435 46497443
Ventricular tachycardia 10.45 9.84 34 187150 16933 46481945
Hyperreflexia 10.42 9.84 4 187180 5250 46493628
Ligament sprain 10.35 9.84 75 187109 10444 46488434
Exposure to allergen 10.33 9.84 7 187177 154 46498724
Stoma obstruction 10.30 9.84 3 187181 6 46498872
Pituitary-dependent Cushing's syndrome 10.30 9.84 3 187181 6 46498872
Therapy partial responder 10.27 9.84 3 187181 4679 46494199
Enterocolitis 10.23 9.84 6 187178 6162 46492716
Choking 10.22 9.84 63 187121 8313 46490565
Hyperplastic cholecystopathy 10.21 9.84 6 187178 102 46498776
Vital capacity decreased 10.20 9.84 12 187172 557 46498321
Respiratory tract infection viral 10.19 9.84 23 187161 1858 46497020
Osteonecrosis 10.14 9.84 61 187123 25683 46473195
Injection site reaction 10.13 9.84 133 187051 47716 46451162
Disorientation 10.03 9.84 97 187087 36821 46462057
Electrocardiogram QT prolonged 10.03 9.84 145 187039 51180 46447698
Gastroenteritis viral 10.02 9.84 114 187070 18005 46480873
Investigation 10.01 9.84 21 187163 1613 46497265
Pyelonephritis 10.01 9.84 30 187154 15327 46483551
Biliary dyskinesia 9.92 9.84 29 187155 2744 46496134
Abdominal discomfort 9.91 9.84 500 186684 150665 46348213
Pharyngitis streptococcal 9.90 9.84 63 187121 8405 46490473
Hilar lymphadenopathy 9.85 9.84 16 187168 1010 46497868

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 1642.78 10.16 1141 90036 35033 29826268
Wheezing 537.30 10.16 562 90615 30376 29830925
Chronic obstructive pulmonary disease 445.45 10.16 622 90555 45504 29815797
Dyspnoea 367.74 10.16 1986 89191 331309 29529992
Obstructive airways disorder 326.77 10.16 249 90928 8810 29852491
Cough 313.38 10.16 966 90211 124676 29736625
Toxicity to various agents 278.74 10.16 96 91081 177087 29684214
Infective pulmonary exacerbation of cystic fibrosis 264.71 10.16 215 90962 8357 29852944
Productive cough 246.91 10.16 375 90802 29578 29831723
Sputum discoloured 226.75 10.16 177 91000 6491 29854810
Eosinophilic granulomatosis with polyangiitis 222.65 10.16 99 91078 1216 29860085
Forced expiratory volume decreased 196.97 10.16 123 91054 3127 29858174
Completed suicide 190.58 10.16 36 91141 99456 29761845
Sinusitis 181.38 10.16 347 90830 32998 29828303
Blood count abnormal 178.10 10.16 198 90979 11454 29849847
Nasal congestion 163.77 10.16 240 90937 18326 29842975
Adrenal suppression 155.16 10.16 62 91115 571 29860730
Pneumonia 151.44 10.16 1617 89560 332689 29528612
Product quality issue 136.56 10.16 222 90955 18552 29842749
Bronchitis 121.60 10.16 326 90851 38799 29822502
Pulmonary function test decreased 120.66 10.16 102 91075 4193 29857108
Chest discomfort 113.30 10.16 350 90827 45130 29816171
Bronchiectasis 107.59 10.16 104 91073 5100 29856201
Drug abuse 100.23 10.16 63 91114 82009 29779292
Respiratory tract congestion 91.86 10.16 98 91079 5408 29855893
Thrombocytopenia 89.60 10.16 176 91001 136868 29724433
Therapeutic product effect incomplete 88.58 10.16 265 90912 33569 29827732
Nasal obstruction 86.39 10.16 42 91135 640 29860661
Nasopharyngitis 82.13 10.16 376 90801 58473 29802828
Cystic fibrosis 80.87 10.16 62 91115 2212 29859089
Nasal polyps 78.08 10.16 50 91127 1329 29859972
Dyspnoea exertional 76.76 10.16 260 90917 35170 29826131
Asthma-chronic obstructive pulmonary disease overlap syndrome 75.25 10.16 38 91139 631 29860670
Sleep disorder due to a general medical condition 71.66 10.16 49 91128 1458 29859843
Neutropenia 70.99 10.16 181 90996 128359 29732942
Blood immunoglobulin E increased 67.81 10.16 50 91127 1680 29859621
Throat irritation 66.15 10.16 104 91073 8444 29852857
Acute kidney injury 65.00 10.16 528 90649 273314 29587987
Multiple organ dysfunction syndrome 64.35 10.16 59 91118 63428 29797873
Upper respiratory tract infection 64.31 10.16 207 90970 27269 29834032
Breath sounds abnormal 63.88 10.16 77 91100 4858 29856443
Renal impairment 62.29 10.16 100 91077 84084 29777217
Respiratory disorder 61.78 10.16 153 91024 17341 29843960
Middle insomnia 60.37 10.16 81 91096 5692 29855609
Influenza 60.32 10.16 277 90900 43121 29818180
Bronchial hyperreactivity 59.46 10.16 40 91137 1158 29860143
Intentional overdose 57.68 10.16 27 91150 41454 29819847
Sinus pain 57.22 10.16 32 91145 659 29860642
Sputum increased 56.10 10.16 46 91131 1811 29859490
Renal failure 53.29 10.16 207 90970 128759 29732542
Nasal disorder 53.15 10.16 37 91140 1134 29860167
Lower respiratory tract infection 52.63 10.16 190 90987 26524 29834777
Cortisol decreased 51.27 10.16 33 91144 885 29860416
Product dose omission issue 51.26 10.16 464 90713 91167 29770134
Off label use 49.79 10.16 502 90675 248788 29612513
Rhinorrhoea 49.14 10.16 157 91020 20597 29840704
Pancytopenia 49.08 10.16 117 91060 84935 29776366
Bone marrow failure 48.71 10.16 15 91162 29770 29831531
Respiratory rate increased 48.71 10.16 93 91084 8822 29852479
Anaemia 47.92 10.16 404 90773 207588 29653713
Inhalation therapy 47.52 10.16 13 91164 28 29861273
Status asthmaticus 47.23 10.16 22 91155 303 29860998
Febrile neutropenia 46.84 10.16 167 91010 106526 29754775
Central obesity 46.64 10.16 26 91151 532 29860769
Dust allergy 44.90 10.16 23 91154 394 29860907
Hepatic function abnormal 44.90 10.16 37 91140 41908 29819393
Oxygen saturation decreased 44.77 10.16 255 90922 43185 29818116
Rhabdomyolysis 44.73 10.16 78 91099 63502 29797799
Malignant neoplasm progression 44.50 10.16 96 91081 72191 29789110
Bronchospasm 43.69 10.16 97 91080 10241 29851060
Blood creatinine increased 43.53 10.16 138 91039 91237 29770064
Sinus disorder 43.08 10.16 72 91105 6153 29855148
Emphysema 42.91 10.16 91 91086 9311 29851990
Cushingoid 42.79 10.16 45 91132 2442 29858859
Hypothalamic pituitary adrenal axis suppression 42.31 10.16 18 91159 197 29861104
Sensitivity to weather change 41.81 10.16 35 91142 1419 29859882
Seasonal allergy 41.25 10.16 61 91116 4692 29856609
Painful respiration 41.13 10.16 33 91144 1259 29860042
Pulmonary function test abnormal 40.96 10.16 34 91143 1362 29859939
Dysphonia 40.62 10.16 139 91038 18893 29842408
Pulmonary mass 40.48 10.16 97 91080 10765 29850536
Cytomegalovirus infection 40.41 10.16 11 91166 23663 29837638
Heart rate increased 40.36 10.16 228 90949 38493 29822808
Leukopenia 40.32 10.16 68 91109 56091 29805210
Osteopenia 39.41 10.16 59 91118 4589 29856712
Vocal cord dysfunction 38.97 10.16 16 91161 159 29861142
Hypoventilation 38.85 10.16 47 91130 2976 29858325
Adrenal insufficiency 38.53 10.16 93 91084 10370 29850931
Respiratory tract infection 38.27 10.16 119 91058 15387 29845914
Neuroleptic malignant syndrome 38.20 10.16 3 91174 16292 29845009
Mycobacterium avium complex infection 37.90 10.16 44 91133 2667 29858634
Platelet count decreased 37.90 10.16 180 90997 105949 29755352
Interstitial lung disease 37.84 10.16 79 91098 60118 29801183
Chorioretinopathy 37.77 10.16 33 91144 1419 29859882
Rhinitis 37.42 10.16 57 91120 4502 29856799
Restrictive pulmonary disease 37.36 10.16 29 91148 1054 29860247
Drug resistance 37.01 10.16 8 91169 20125 29841176
Sleep apnoea syndrome 36.75 10.16 124 91053 16733 29844568
Anosmia 36.13 10.16 38 91139 2062 29859239
Overdose 35.69 10.16 134 91043 84203 29777098
Secondary adrenocortical insufficiency 34.58 10.16 27 91150 990 29860311
Rhinalgia 34.47 10.16 19 91158 380 29860921
Increased viscosity of bronchial secretion 33.86 10.16 16 91161 228 29861073
Gastrooesophageal reflux disease 33.66 10.16 190 90987 32065 29829236
Sinus congestion 33.19 10.16 55 91122 4667 29856634
Growth retardation 33.12 10.16 32 91145 1568 29859733
Sneezing 32.59 10.16 52 91125 4275 29857026
Cerebral infarction 32.51 10.16 20 91157 26353 29834948
Cushing's syndrome 31.87 10.16 19 91158 443 29860858
Hospitalisation 31.51 10.16 237 90940 44082 29817219
Eosinophil count increased 31.44 10.16 70 91107 7403 29853898
Nasal discharge discolouration 31.24 10.16 15 91162 222 29861079
Product complaint 31.02 10.16 60 91117 5746 29855555
Death 30.94 10.16 840 90337 356443 29504858
Malaise 30.94 10.16 695 90482 166267 29695034
Rhinitis allergic 30.86 10.16 41 91136 2853 29858448
Foetal malformation 30.83 10.16 13 91164 139 29861162
Peripheral swelling 30.50 10.16 302 90875 60772 29800529
Hepatocellular injury 30.45 10.16 20 91157 25451 29835850
Chronic sinusitis 30.07 10.16 30 91147 1529 29859772
Blood urea increased 29.66 10.16 31 91146 31350 29829951
Bronchial wall thickening 29.66 10.16 18 91159 434 29860867
Body temperature decreased 29.51 10.16 80 91097 9575 29851726
Neutrophil count decreased 29.02 10.16 53 91124 42401 29818900
Mucosal inflammation 28.96 10.16 30 91147 30464 29830837
Septic shock 28.94 10.16 98 91079 63509 29797792
Ear infection 28.73 10.16 67 91110 7307 29853994
Blood pressure increased 28.66 10.16 340 90837 71588 29789713
Depressed level of consciousness 28.63 10.16 45 91132 38177 29823124
Mite allergy 28.47 10.16 14 91163 219 29861082
Delirium 28.43 10.16 50 91127 40581 29820720
Upper-airway cough syndrome 28.30 10.16 38 91139 2672 29858629
Sepsis 28.24 10.16 297 90880 146098 29715203
Peritonitis 28.07 10.16 15 91162 21360 29839941
Cholestasis 27.97 10.16 21 91156 24929 29836372
General physical health deterioration 27.79 10.16 184 90993 99760 29761541
Respiratory tract irritation 27.68 10.16 12 91165 138 29861163
Alanine aminotransferase increased 27.67 10.16 124 91053 74152 29787149
Cardio-respiratory arrest 27.66 10.16 86 91091 57220 29804081
C-reactive protein increased 27.36 10.16 57 91120 43416 29817885
Lung diffusion test decreased 27.10 10.16 19 91158 589 29860712
Asthmatic crisis 26.34 10.16 17 91160 458 29860843
Weight decreased 26.33 10.16 623 90554 150298 29711003
Lower respiratory tract congestion 26.30 10.16 23 91154 990 29860311
Serotonin syndrome 25.88 10.16 11 91166 17880 29843421
Cardiac arrest 25.78 10.16 171 91006 92679 29768622
Coma 25.48 10.16 53 91124 40396 29820905
Granulomatous rosacea 25.40 10.16 12 91165 171 29861130
Forced vital capacity decreased 25.18 10.16 20 91157 752 29860549
Trisomy 18 25.00 10.16 13 91164 230 29861071
Hepatic failure 24.63 10.16 41 91136 34002 29827299
Walking aid user 24.57 10.16 26 91151 1421 29859880
Toxic epidermal necrolysis 24.44 10.16 12 91165 17928 29843373
Disseminated intravascular coagulation 24.42 10.16 19 91158 22152 29839149
Fatigue 24.39 10.16 1201 89976 319472 29541829
Aspartate aminotransferase increased 24.15 10.16 105 91072 63317 29797984
Drug reaction with eosinophilia and systemic symptoms 23.85 10.16 31 91146 28457 29832844
Weight increased 23.51 10.16 339 90838 74574 29786727
Gamma-glutamyltransferase increased 23.49 10.16 33 91144 29317 29831984
Hypotension 23.08 10.16 451 90726 200114 29661187
Blood pressure systolic increased 22.90 10.16 99 91078 15011 29846290
Eosinophil count 22.69 10.16 10 91167 120 29861181
Agranulocytosis 22.69 10.16 20 91157 21922 29839379
Foetal exposure during pregnancy 22.65 10.16 49 91128 36822 29824479
Smoke sensitivity 22.54 10.16 11 91166 169 29861132
Chest injury 22.26 10.16 24 91153 1340 29859961
Treatment failure 22.22 10.16 45 91132 34634 29826667
Hepatotoxicity 22.03 10.16 14 91163 18131 29843170
Poisoning 22.02 10.16 4 91173 11378 29849923
Peritonitis bacterial 22.01 10.16 4 91173 11374 29849927
Suffocation feeling 21.46 10.16 16 91161 547 29860754
Bronchopulmonary aspergillosis allergic 21.44 10.16 13 91164 313 29860988
Product use in unapproved indication 21.33 10.16 134 91043 73559 29787742
Shock 21.13 10.16 23 91154 22836 29838465
Transposition of the great vessels 21.06 10.16 15 91162 477 29860824
Snoring 20.76 10.16 34 91143 2857 29858444
Bronchial obstruction 20.71 10.16 24 91153 1452 29859849
Reversible airways obstruction 20.63 10.16 12 91165 267 29861034
Drug intolerance 20.45 10.16 70 91107 45221 29816080
Ascites 20.24 10.16 50 91127 35871 29825430
Conjunctivitis allergic 19.96 10.16 15 91162 519 29860782
Blood lactate dehydrogenase increased 19.87 10.16 20 91157 20581 29840720
Hot flush 19.86 10.16 93 91084 14587 29846714
Mycotic allergy 19.75 10.16 10 91167 167 29861134
Nasal inflammation 19.60 10.16 11 91166 228 29861073
Altered state of consciousness 19.60 10.16 19 91158 19900 29841401
Lung hyperinflation 19.50 10.16 18 91159 832 29860469
Oropharyngeal pain 19.47 10.16 151 91026 28345 29832956
Loss of personal independence in daily activities 19.35 10.16 122 91055 21413 29839888
Hyperbilirubinaemia 19.33 10.16 14 91163 16928 29844373
Hypertrophic osteoarthropathy 19.27 10.16 8 91169 82 29861219
Acute hepatic failure 19.26 10.16 6 91171 11821 29849480
Haemoptysis 19.23 10.16 161 91016 30917 29830384
Blood bilirubin increased 19.11 10.16 53 91124 36583 29824718
Haemoglobin decreased 19.05 10.16 239 90938 113859 29747442
Respiratory symptom 18.97 10.16 17 91160 756 29860545
Carcinoid tumour of the gastrointestinal tract 18.94 10.16 7 91170 51 29861250
Blood immunoglobulin E decreased 18.59 10.16 7 91170 54 29861247
Tumour lysis syndrome 18.51 10.16 8 91169 12877 29848424
Hypersensitivity 18.37 10.16 248 90929 53780 29807521
Headache 18.32 10.16 703 90474 181603 29679698
Peak expiratory flow rate decreased 18.17 10.16 9 91168 143 29861158
Confusional state 18.09 10.16 295 90882 134539 29726762
Nephropathy toxic 18.05 10.16 5 91172 10634 29850667
Immune reconstitution inflammatory syndrome 18.04 10.16 3 91174 9098 29852203
Rales 18.04 10.16 52 91125 6448 29854853
Skin striae 17.99 10.16 13 91164 423 29860878
Drug-induced liver injury 17.96 10.16 23 91154 21251 29840050
Multiple allergies 17.88 10.16 27 91150 2116 29859185
Myocardial infarction 17.81 10.16 272 90905 125353 29735948
Migraine 17.74 10.16 82 91095 12792 29848509
Rhonchi 17.68 10.16 24 91153 1705 29859596
Cerebral haemorrhage 17.59 10.16 47 91130 32840 29828461
Throat tightness 17.56 10.16 55 91122 7137 29854164
Sputum purulent 17.52 10.16 13 91164 441 29860860
Choking 17.19 10.16 43 91134 4903 29856398
Stress 17.18 10.16 113 91064 20122 29841179
Jaundice 16.94 10.16 47 91130 32439 29828862
Cystic fibrosis respiratory infection suppression 16.92 10.16 12 91165 379 29860922
Tracheal disorder 16.63 10.16 8 91169 119 29861182
Acute respiratory failure 16.58 10.16 135 91042 25715 29835586
Lipohypertrophy 16.45 10.16 11 91166 315 29860986
Forced expiratory flow decreased 16.39 10.16 8 91169 123 29861178
Hyposmia 16.33 10.16 9 91168 180 29861121
Acute respiratory distress syndrome 16.31 10.16 29 91148 23443 29837858
Liver disorder 16.26 10.16 42 91135 29680 29831621
Blood test abnormal 16.11 10.16 45 91132 5480 29855821
Limb injury 16.07 10.16 62 91115 8929 29852372
Acute myocardial infarction 15.97 10.16 95 91082 52844 29808457
Haemophagocytic lymphohistiocytosis 15.88 10.16 5 91172 9786 29851515
Nasal discomfort 15.84 10.16 19 91158 1192 29860109
Nasal oedema 15.83 10.16 11 91166 336 29860965
Contusion 15.76 10.16 155 91022 31125 29830176
Bone deformity 15.75 10.16 6 91171 48 29861253
Drug interaction 15.73 10.16 475 90702 199093 29662208
Haemodialysis 15.71 10.16 7 91170 11066 29850235
Hyperkalaemia 15.70 10.16 127 91050 65883 29795418
Anxiety 15.65 10.16 371 90806 89500 29771801
Eye pruritus 15.65 10.16 36 91141 3891 29857410
Oral candidiasis 15.62 10.16 71 91106 11000 29850301
Vision blurred 15.49 10.16 195 90982 41621 29819680
Coma uraemic 15.33 10.16 6 91171 52 29861249
Alveolar bone resorption 15.27 10.16 5 91172 24 29861277
Hypoacusis 15.22 10.16 84 91093 14055 29847246
Eosinophilic oesophagitis 15.21 10.16 9 91168 207 29861094
Rheumatoid arthritis 15.20 10.16 69 91108 41128 29820173
Hypokalaemia 15.18 10.16 90 91087 50102 29811199
Lung consolidation 15.10 10.16 41 91136 4911 29856390
White blood cell count decreased 15.09 10.16 173 91004 83774 29777527
Gastroenteritis viral 15.07 10.16 46 91131 5887 29855414
Vomiting 15.00 10.16 533 90644 219285 29642016
Hyperthermia 14.94 10.16 6 91171 10093 29851208
Blood corticotrophin decreased 14.93 10.16 8 91169 151 29861150
Neurotoxicity 14.90 10.16 11 91166 13171 29848130
Hypersomnia 14.81 10.16 71 91106 11245 29850056
Extrapyramidal disorder 14.80 10.16 7 91170 10686 29850615
Nervous system neoplasm 14.79 10.16 8 91169 154 29861147
Bronchial disorder 14.77 10.16 16 91161 898 29860403
Thrombotic microangiopathy 14.69 10.16 4 91173 8606 29852695
Back injury 14.68 10.16 33 91144 3512 29857789
Psychotic disorder 14.58 10.16 27 91150 21488 29839813
Hepatic haematoma 14.56 10.16 12 91165 476 29860825
Infective exacerbation of chronic obstructive airways disease 14.55 10.16 20 91157 1438 29859863
Pyrexia 14.47 10.16 741 90436 293748 29567553
Suicide attempt 14.43 10.16 60 91117 36637 29824664
Nasal polypectomy 14.39 10.16 3 91174 0 29861301
Bradycardia 14.27 10.16 129 91048 65397 29795904
Malpositioned teeth 14.21 10.16 5 91172 31 29861270
Rhinitis perennial 14.21 10.16 7 91170 110 29861191
Proteinuria 14.11 10.16 17 91160 16128 29845173
Increased bronchial secretion 14.10 10.16 19 91158 1340 29859961
Allergic sinusitis 14.08 10.16 6 91171 66 29861235
Atopy 13.98 10.16 7 91170 114 29861187
Pneumocystis jirovecii pneumonia 13.95 10.16 19 91158 17101 29844200
Administration site swelling 13.91 10.16 8 91169 174 29861127
Restlessness 13.90 10.16 30 91147 22569 29838732
Necrotising oesophagitis 13.86 10.16 11 91166 413 29860888
Nocturnal dyspnoea 13.85 10.16 12 91165 510 29860791
Sleep terror 13.78 10.16 14 91163 729 29860572
Hepatocellular carcinoma 13.75 10.16 6 91171 9604 29851697
Transaminases increased 13.73 10.16 32 91145 23425 29837876
Metabolic acidosis 13.67 10.16 63 91114 37398 29823903
Cortisol abnormal 13.58 10.16 5 91172 36 29861265
Lung disorder 13.53 10.16 151 91026 31318 29829983
Tubulointerstitial nephritis 13.46 10.16 21 91156 17870 29843431
Panic reaction 13.42 10.16 19 91158 1404 29859897
Increased upper airway secretion 13.41 10.16 21 91156 1699 29859602
Drug level increased 13.37 10.16 22 91155 18332 29842969
Blood alkaline phosphatase increased 13.32 10.16 50 91127 31437 29829864
Deformity thorax 13.23 10.16 5 91172 39 29861262
Liver injury 13.19 10.16 11 91166 12389 29848912
Polyp 13.08 10.16 30 91147 3236 29858065
Encephalopathy 13.07 10.16 52 91125 32153 29829148
Epilepsy 13.06 10.16 26 91151 20143 29841158
Lung transplant 13.04 10.16 22 91155 1894 29859407
Aspirin-exacerbated respiratory disease 13.04 10.16 10 91167 357 29860944
Personality change 12.96 10.16 37 91140 4563 29856738
Tendon calcification 12.91 10.16 5 91172 42 29861259
Status epilepticus 12.82 10.16 9 91168 11063 29850238
Dyspnoea at rest 12.80 10.16 26 91151 2580 29858721
Hilar lymphadenopathy 12.71 10.16 14 91163 801 29860500
Hepatitis 12.69 10.16 31 91146 22325 29838976
Infective exacerbation of bronchiectasis 12.65 10.16 11 91166 470 29860831
Palmar-plantar erythrodysaesthesia syndrome 12.63 10.16 16 91161 14854 29846447
Spirometry abnormal 12.56 10.16 9 91168 289 29861012
Crepitations 12.36 10.16 28 91149 2996 29858305
Pre-existing condition improved 12.35 10.16 22 91155 1979 29859322
Eosinophilic bronchitis 12.33 10.16 5 91172 48 29861253
Forced expiratory volume abnormal 12.32 10.16 3 91174 3 29861298
Viral upper respiratory tract infection 12.31 10.16 26 91151 2652 29858649
Neutropenic sepsis 12.28 10.16 10 91167 11399 29849902
Aphonia 12.23 10.16 28 91149 3016 29858285
Neck pain 12.17 10.16 107 91070 20837 29840464
Flour sensitivity 12.15 10.16 5 91172 50 29861251
Extra dose administered 12.10 10.16 27 91150 2859 29858442
Graft versus host disease 12.09 10.16 8 91169 10142 29851159
Seizure 12.05 10.16 219 90958 98256 29763045
Epidural lipomatosis 12 10.16 8 91169 228 29861073
Respiratory tract oedema 12.00 10.16 10 91167 403 29860898
Disease progression 11.98 10.16 171 91006 79703 29781598
Stevens-Johnson syndrome 11.92 10.16 22 91155 17534 29843767
Throat clearing 11.88 10.16 8 91169 232 29861069
Drug eruption 11.87 10.16 22 91155 17504 29843797
Bronchitis bacterial 11.84 10.16 13 91164 741 29860560
Pseudomonas infection 11.77 10.16 63 91114 10419 29850882
Feeling of body temperature change 11.75 10.16 17 91160 1282 29860019
Infusion site swelling 11.60 10.16 19 91158 1597 29859704
Posterior reversible encephalopathy syndrome 11.59 10.16 6 91171 8701 29852600
Prothrombin time prolonged 11.54 10.16 7 91170 9296 29852005
Abnormal behaviour 11.50 10.16 124 91053 25499 29835802
Ischaemic stroke 11.41 10.16 20 91157 16255 29845046
Haemophilus infection 11.40 10.16 14 91163 900 29860401
Ligament sprain 11.40 10.16 26 91151 2794 29858507
Ventricular tachycardia 11.37 10.16 36 91141 23826 29837475
Lymphopenia 11.35 10.16 14 91163 13149 29848152
Back pain 11.34 10.16 400 90777 102196 29759105
Spinal osteoarthritis 11.34 10.16 44 91133 6355 29854946
Plasma cell myeloma 11.31 10.16 106 91071 53356 29807945
Pulmonary congestion 11.28 10.16 70 91107 12217 29849084
Dermatitis atopic 11.23 10.16 15 91162 1049 29860252
Pulmonary artery dilatation 11.21 10.16 6 91171 113 29861188
Haemolysis 11.19 10.16 4 91173 7227 29854074
Blood pressure diastolic decreased 11.17 10.16 43 91134 6188 29855113
Diarrhoea 11.14 10.16 871 90306 333232 29528069
Acidosis 11.13 10.16 9 91168 10292 29851009
ACTH stimulation test abnormal 11.12 10.16 3 91174 6 29861295
Plethoric face 11.12 10.16 3 91174 6 29861295
Administration site pain 11.07 10.16 7 91170 182 29861119
Respiratory distress 11.06 10.16 151 91026 32821 29828480
Intentional self-injury 11.04 10.16 15 91162 13517 29847784
Ileus 11.01 10.16 19 91158 15536 29845765
Acute myeloid leukaemia 11.00 10.16 24 91153 17982 29843319
Pathogen resistance 10.90 10.16 6 91171 8404 29852897
Diabetic ketoacidosis 10.88 10.16 20 91157 15966 29845335
Eye swelling 10.84 10.16 55 91122 8909 29852392
Eye irritation 10.78 10.16 40 91137 5656 29855645
Substance abuse 10.72 10.16 4 91173 7036 29854265
Nausea 10.72 10.16 769 90408 296188 29565113
Viral infection 10.67 10.16 81 91096 15104 29846197
Infusion site pruritus 10.55 10.16 11 91166 591 29860710
Cytopenia 10.54 10.16 6 91171 8250 29853051
Victim of child abuse 10.52 10.16 8 91169 282 29861019
Muscle spasms 10.48 10.16 265 90912 64573 29796728
Electrocardiogram QT prolonged 10.44 10.16 65 91112 35770 29825531
Hypohidrosis 10.33 10.16 7 91170 205 29861096
Oral mucosal blistering 10.31 10.16 19 91158 1754 29859547
Enuresis 10.30 10.16 19 91158 1755 29859546
Cystic fibrosis related diabetes 10.29 10.16 6 91171 134 29861167
Toxic skin eruption 10.27 10.16 11 91166 11004 29850297
Alpha-1 antitrypsin deficiency 10.26 10.16 3 91174 9 29861292
IPEX syndrome 10.26 10.16 3 91174 9 29861292
Neoplasm progression 10.22 10.16 25 91152 17998 29843303
Swollen tongue 10.20 10.16 72 91105 13120 29848181
CADASIL 10.18 10.16 5 91172 78 29861223
Ultrasound skull abnormal 10.18 10.16 5 91172 78 29861223
Pharyngeal erythema 10.16 10.16 10 91167 501 29860800

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
CHEBI has role CHEBI:49167 anti-asthmatic agents
CHEBI has role CHEBI:50857 anti-allergic agents
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
FDA EPC N0000175576 Corticosteroid
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists
CHEBI has role CHEBI:35472 anti-inflammatory drugs
CHEBI has role CHEBI:35523 bronchodilator agents
CHEBI has role CHEBI:37962 adrenergic neuron agents
CHEBI has role CHEBI:50177 dermatological 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
Bronchospasm Prevention with COPD indication
Chronic Non-Allergic Rhinitis 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
Nasal Candidiasis contraindication
Untreated Fungal Infection contraindication
Uncontrolled Bacterial Infections contraindication
Nasal Septal Ulcers contraindication
Nasal Trauma contraindication

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)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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

External reference:

IDSource
4020180 VUID
N0000148122 NUI
D01708 KEGG_DRUG
90566-53-3 SECONDARY_CAS_RN
4020180 VANDF
4020529 VANDF
C0591521 UMLSCUI
C0082607 UMLSCUI
CHEBI:31441 CHEBI
CHEBI:5134 CHEBI
CHEMBL1473 ChEMBL_ID
DB00588 DRUGBANK_ID
D000068298 MESH_DESCRIPTOR_UI
7080 IUPHAR_LIGAND_ID
5636 INN_ID
O2GMZ0LF5W UNII
CUT2W21N7U UNII
444036 PUBCHEM_CID
5311101 PUBCHEM_CID
6699 IUPHAR_LIGAND_ID
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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DYMISTA HUMAN PRESCRIPTION DRUG LABEL 2 0037-0245 SPRAY, METERED 50 ug NULLSAL NDA 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0054-0326 POWDER 100 ug RESPIRATORY (INHALATION) ANDA 29 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0054-0327 POWDER 250 ug RESPIRATORY (INHALATION) ANDA 29 sections
Fluticasone Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0054-3270 SPRAY, METERED 50 ug NULLSAL 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 0093-3608 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
Good Sense 24 hour allergy nasal HUMAN OTC DRUG LABEL 1 0113-0028 SPRAY, METERED 50 ug NULLSAL ANDA 17 sections
Good Sense 24 hour allergy nasal HUMAN OTC DRUG LABEL 1 0113-0285 SPRAY, METERED 50 ug NULLSAL ANDA 17 sections
basic care allergy relief nasal HUMAN OTC DRUG LABEL 1 0113-7117 SPRAY, METERED 50 ug NULLSAL ANDA 17 sections
FLONULLSEALLERGY RELIEF HUMAN OTC DRUG LABEL 1 0135-0576 SPRAY, METERED 50 ug NULLSAL NDA 16 sections
CHILDRENS FLONULLSEALLERGY RELIEF HUMAN OTC DRUG LABEL 1 0135-0582 SPRAY, METERED 50 ug NULLSAL NDA 16 sections
FLUTICASONE PROPIONULLTE HUMAN PRESCRIPTION DRUG LABEL 1 0168-0332 CREAM 0.50 mg TOPICAL ANDA 21 sections
Fluticasone Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0333 OINTMENT 0.05 mg TOPICAL ANDA 25 sections
FLUTICASONE PROPIONULLTE 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 0173-0601 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
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0695 POWDER 100 ug RESPIRATORY (INHALATION) NDA 27 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0696 POWDER 250 ug RESPIRATORY (INHALATION) NDA 27 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0697 POWDER 500 ug RESPIRATORY (INHALATION) NDA 27 sections
ADVAIR HFA HUMAN PRESCRIPTION DRUG LABEL 2 0173-0715 AEROSOL, METERED 45 ug RESPIRATORY (INHALATION) NDA 28 sections
ADVAIR HFA HUMAN PRESCRIPTION DRUG LABEL 2 0173-0716 AEROSOL, METERED 115 ug RESPIRATORY (INHALATION) NDA 28 sections
ADVAIR HFA HUMAN PRESCRIPTION DRUG LABEL 2 0173-0717 AEROSOL, METERED 230 ug RESPIRATORY (INHALATION) NDA 28 sections
FLOVENTHFA HUMAN PRESCRIPTION DRUG LABEL 1 0173-0718 AEROSOL, METERED 44 ug RESPIRATORY (INHALATION) NDA 26 sections
FLOVENTHFA HUMAN PRESCRIPTION DRUG LABEL 1 0173-0719 AEROSOL, METERED 110 ug RESPIRATORY (INHALATION) NDA 26 sections
FLOVENTHFA HUMAN PRESCRIPTION DRUG LABEL 1 0173-0720 AEROSOL, METERED 220 ug RESPIRATORY (INHALATION) NDA 26 sections
24 Hour Allergy Nasal HUMAN OTC DRUG LABEL 1 0363-0024 SPRAY, METERED 50 ug NULLSAL ANDA 17 sections
Fluticasone Propionate HUMAN OTC DRUG LABEL 1 0363-0652 SPRAY, METERED 50 ug NULLSAL ANDA 16 sections
Allergy Nasal HUMAN OTC DRUG LABEL 1 0363-0881 SPRAY, METERED 50 ug NULLSAL ANDA 17 sections