salmeterol Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
bronchodilators, phenethylamine derivatives 2419 89365-50-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • serevent
  • salmeterol
  • salmeterol xinafoate
Salmeterol is a selective long acting beta2-adrenoceptor agonist. In vitro studies show salmeterol to be at least 50 times more selective for beta2-adrenoceptors than albuterol. Although beta2-adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-adrenoceptors are the predominant receptors in the heart, there are also beta2-adrenoceptors in the human heart comprising 10% to 50% of the total beta-adrenoceptors. The precise function of these receptors has not been established, but their presence raises the possibility that even selective beta2-agonists may have cardiac effects. The pharmacologic effects of beta2-adrenoceptor agonist drugs, including salmeterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. In vitro tests show that salmeterol is a potent and long-lasting inhibitor of the release of mast cell mediators, such as histamine, leukotrienes, and prostaglandin D2, from human lung. Salmeterol inhibits histamine-induced plasma protein extravasation and inhibits platelet-activating factor-induced eosinophil accumulation in the lungs of guinea pigs when administered by the inhaled route. In humans, single doses of salmeterol administered via inhalation aerosol attenuate allergen-induced bronchial hyper-responsiveness. It has received approval to be used in combination with fluticasone.
  • Molecular weight: 415.57
  • Formula: C25H37NO4
  • CLOGP: 3.06
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 4
  • TPSA: 81.95
  • ALOGS: -5.26
  • ROTB: 16

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.10 mg Inhal.aerosol
0.10 mg Inhal.powder

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.00 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
March 26, 2021 EMA TEVA B.V.
Feb. 4, 1994 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 2780.95 9.92 1924 92524 89618 46501996
Wheezing 874.56 9.92 781 93667 52605 46539009
Chronic obstructive pulmonary disease 680.28 9.92 704 93744 56929 46534685
Dyspnoea 662.37 9.92 2411 92037 513137 46078477
Obstructive airways disorder 382.42 9.92 272 94176 13140 46578474
Cough 368.61 9.92 1162 93286 229087 46362527
Forced expiratory volume decreased 350.71 9.92 182 94266 4922 46586692
Productive cough 348.61 9.92 470 93978 50245 46541369
Sputum discoloured 290.08 9.92 226 94222 12552 46579062
Completed suicide 245.20 9.92 12 94436 145908 46445706
Pneumonia 228.19 9.92 1419 93029 374901 46216713
Chest discomfort 223.33 9.92 535 93913 89734 46501880
Bronchitis 190.76 9.92 558 93890 105421 46486193
Temperature regulation disorder 178.40 9.92 101 94347 3259 46588355
Product quality issue 172.17 9.92 280 94168 35368 46556246
Eosinophilic granulomatosis with polyangiitis 163.22 9.92 78 94370 1758 46589856
Toxicity to various agents 152.42 9.92 123 94325 211643 46379971
Blood count abnormal 148.36 9.92 182 94266 17696 46573918
Food allergy 143.15 9.92 116 94332 6817 46584797
Middle insomnia 130.04 9.92 126 94322 9389 46582225
Immunodeficiency 124.57 9.92 143 94305 12963 46578651
Upper respiratory tract infection 124.35 9.92 345 94103 63211 46528403
Coeliac disease 123.49 9.92 108 94340 7053 46584561
Malaise 121.34 9.92 1110 93338 330122 46261492
Infective pulmonary exacerbation of cystic fibrosis 116.61 9.92 126 94322 10681 46580933
Breath sounds abnormal 111.55 9.92 106 94342 7709 46583905
Nasal congestion 105.02 9.92 272 94176 47841 46543773
Dyspnoea exertional 100.35 9.92 275 94173 50014 46541600
Lower respiratory tract infection 99.91 9.92 291 94157 54798 46536816
Dysphonia 97.40 9.92 230 94218 38184 46553430
Drug abuse 95.44 9.92 9 94439 63399 46528215
Treatment failure 94.55 9.92 35 94413 93052 46498562
Off label use 93.55 9.92 423 94025 379418 46212196
Neutropenia 91.24 9.92 93 94355 143111 46448503
Synovitis 86.02 9.92 11 94437 61064 46530550
Lung disorder 85.60 9.92 236 94212 43068 46548546
Blood immunoglobulin E increased 85.34 9.92 50 94398 1723 46589891
Influenza 84.24 9.92 381 94067 88889 46502725
Febrile neutropenia 82.85 9.92 44 94404 94583 46497031
Respiratory tract congestion 82.64 9.92 115 94333 12649 46578965
Sinusitis 82.38 9.92 496 93952 129272 46462342
Pulmonary function test decreased 76.94 9.92 63 94385 3757 46587857
Intentional overdose 75.71 9.92 19 94429 64925 46526689
Nasal polyps 72.80 9.92 49 94399 2161 46589453
Pancytopenia 70.94 9.92 42 94406 85016 46506598
Thrombocytopenia 64.08 9.92 98 94350 126483 46465131
Eosinophil count increased 63.52 9.92 79 94369 7787 46583827
Heart rate increased 63.08 9.92 309 94139 74482 46517132
Oxygen saturation decreased 62.86 9.92 292 94156 68872 46522742
Sleep disorder due to a general medical condition 62.81 9.92 54 94394 3445 46588169
Forced vital capacity decreased 61.32 9.92 32 94416 875 46590739
Bronchospasm 60.91 9.92 112 94336 15595 46576019
Bursitis 60.61 9.92 128 94320 19714 46571900
Rash erythematous 59.92 9.92 179 94269 34171 46557443
Nasopharyngitis 59.72 9.92 523 93925 153475 46438139
Malignant neoplasm progression 58.60 9.92 29 94419 64897 46526717
Hand deformity 57.52 9.92 3 94445 34571 46557043
Hypersensitivity 57.50 9.92 509 93939 149812 46441802
Asthmatic crisis 56.57 9.92 36 94412 1442 46590172
Emphysema 56.27 9.92 80 94368 8974 46582640
Systemic lupus erythematosus 56.04 9.92 31 94417 65149 46526465
Secretion discharge 55.16 9.92 80 94368 9139 46582475
Oropharyngeal pain 54.59 9.92 295 94153 73873 46517741
Fluid retention 54.35 9.92 226 94222 50820 46540794
Rales 53.92 9.92 81 94367 9550 46582064
Asphyxia 53.82 9.92 60 94388 5266 46586348
Rheumatoid arthritis 53.49 9.92 277 94171 239938 46351676
Peak expiratory flow rate decreased 53.49 9.92 26 94422 609 46591005
Haemoptysis 53.01 9.92 144 94304 26045 46565569
Seasonal allergy 52.87 9.92 96 94352 13238 46578376
Bronchial wall thickening 52.44 9.92 28 94420 803 46590811
Therapeutic product effect incomplete 51.66 9.92 302 94146 77851 46513763
Hypoventilation 49.83 9.92 51 94397 4059 46587555
Bronchiectasis 48.84 9.92 76 94372 9240 46582374
Drug ineffective 47.72 9.92 1028 93420 676810 45914804
Rhinorrhoea 47.62 9.92 207 94241 47458 46544156
Eye pruritus 47.60 9.92 86 94362 11812 46579802
Asthma-chronic obstructive pulmonary disease overlap syndrome 47.23 9.92 22 94426 467 46591147
Inhalation therapy 46.65 9.92 13 94435 53 46591561
Drug intolerance 46.28 9.92 148 94300 146901 46444713
Status asthmaticus 44.01 9.92 26 94422 910 46590704
Lung neoplasm malignant 43.97 9.92 97 94351 15392 46576222
Cystic fibrosis 43.33 9.92 45 94403 3643 46587971
Prolonged expiration 42.62 9.92 19 94429 363 46591251
Anaemia 41.96 9.92 324 94124 255455 46336159
Death 41.66 9.92 456 93992 335092 46256522
Alopecia 40.97 9.92 179 94269 162235 46429379
Blood pressure systolic increased 40.19 9.92 139 94309 28648 46562966
Rhinitis allergic 39.96 9.92 59 94389 6849 46584765
Smoke sensitivity 38.93 9.92 16 94432 248 46591366
Reversible airways obstruction 38.69 9.92 20 94428 536 46591078
Adrenal insufficiency 38.17 9.92 83 94365 13041 46578573
Aphonia 37.78 9.92 62 94386 7883 46583731
Sputum retention 37.65 9.92 18 94430 406 46591208
Rhonchi 37.38 9.92 33 94415 2182 46589432
Increased viscosity of bronchial secretion 37.01 9.92 16 94432 283 46591331
Respiratory tract infection 36.98 9.92 139 94309 29833 46561781
Increased upper airway secretion 36.92 9.92 39 94409 3220 46588394
Maternal exposure during pregnancy 36.78 9.92 97 94351 102452 46489162
Diarrhoea 35.53 9.92 862 93586 558740 46032874
Glossodynia 35.47 9.92 23 94425 44350 46547264
Leukopenia 35.45 9.92 52 94396 68291 46523323
Alanine aminotransferase increased 35.40 9.92 79 94369 88372 46503242
White blood cell count decreased 34.57 9.92 114 94334 112117 46479497
Respiratory rate increased 34.05 9.92 73 94375 11360 46580254
Lung hyperinflation 33.98 9.92 24 94424 1145 46590469
Infective exacerbation of chronic obstructive airways disease 33.78 9.92 24 94424 1156 46590458
Respiratory symptom 33.26 9.92 30 94418 2040 46589574
Pulmonary mass 33.00 9.92 95 94353 17762 46573852
Eosinophil count abnormal 32.94 9.92 17 94431 454 46591160
Rhinitis 32.72 9.92 58 94390 7848 46583766
Spirometry abnormal 32.51 9.92 13 94435 187 46591427
Joint swelling 32.33 9.92 200 94248 165873 46425741
Oral candidiasis 32.14 9.92 93 94355 17439 46574175
Lower respiratory tract congestion 31.95 9.92 28 94420 1833 46589781
Hepatotoxicity 31.81 9.92 6 94442 25003 46566611
Acute respiratory failure 31.79 9.92 130 94318 29008 46562606
Contraindicated product administered 30.71 9.92 73 94375 79874 46511740
Eosinophilic pneumonia chronic 30.69 9.92 10 94438 76 46591538
Platelet count decreased 30.53 9.92 102 94346 99922 46491692
Serotonin syndrome 30.41 9.92 6 94442 24214 46567400
Humidity intolerance 30.19 9.92 15 94433 369 46591245
Nocturnal dyspnoea 29.96 9.92 21 94427 990 46590624
Respiratory disorder 29.94 9.92 122 94326 27178 46564436
Arthropathy 29.70 9.92 81 94367 84619 46506995
Atopy 29.62 9.92 12 94436 179 46591435
Pulmonary function test abnormal 29.59 9.92 23 94425 1272 46590342
C-reactive protein abnormal 29.54 9.92 4 94444 21266 46570348
Bronchial disorder 29.51 9.92 21 94427 1014 46590600
Aspartate aminotransferase increased 29.33 9.92 73 94375 78627 46512987
Sensitivity to weather change 28.91 9.92 45 94403 5471 46586143
Sputum purulent 28.49 9.92 19 94429 825 46590789
Upper-airway cough syndrome 27.99 9.92 54 94394 7793 46583821
Coma 27.79 9.92 47 94401 58302 46533312
Viral infection 27.71 9.92 128 94320 30107 46561507
Nasal discharge discolouration 27.33 9.92 23 94425 1425 46590189
Neurosensory hypoacusis 27.08 9.92 13 94435 296 46591318
Gastrooesophageal reflux disease 26.99 9.92 249 94199 74095 46517519
Device expulsion 26.88 9.92 11 94437 27531 46564083
Musculoskeletal stiffness 26.56 9.92 105 94343 97888 46493726
Throat irritation 26.23 9.92 122 94326 28779 46562835
Hypercapnia 26.03 9.92 39 94409 4587 46587027
Total lung capacity decreased 26.00 9.92 20 94428 1089 46590525
Infusion related reaction 25.84 9.92 111 94337 101097 46490517
Sneezing 25.72 9.92 70 94378 12671 46578943
Magnetic resonance imaging thoracic abnormal 25.43 9.92 7 94441 27 46591587
Body temperature decreased 25.42 9.92 72 94376 13337 46578277
C-reactive protein increased 25.40 9.92 50 94398 58540 46533074
Therapeutic product effect decreased 25.37 9.92 84 94364 82517 46509097
Disease progression 25.27 9.92 97 94351 91203 46500411
Eosinophilic oesophagitis 25.17 9.92 11 94437 200 46591414
Total lung capacity increased 25.11 9.92 17 94431 757 46590857
Cardio-respiratory arrest 24.34 9.92 53 94395 59816 46531798
Perfume sensitivity 24.30 9.92 15 94433 569 46591045
Red blood cell sedimentation rate increased 24.27 9.92 8 94440 22881 46568733
Chest pain 23.99 9.92 495 93953 175829 46415785
Eye infection bacterial 23.98 9.92 9 94439 108 46591506
Lactic acidosis 23.96 9.92 20 94428 33889 46557725
Hyposmia 23.85 9.92 13 94435 389 46591225
Cytomegalovirus infection 23.85 9.92 4 94444 18140 46573474
Laryngitis 23.84 9.92 56 94392 9260 46582354
Dizziness 23.63 9.92 876 93572 339538 46252076
Bronchial neoplasm 23.42 9.92 11 94437 238 46591376
Rash 23.42 9.92 546 93902 355966 46235648
Increased bronchial secretion 23.24 9.92 22 94426 1592 46590022
Urticaria 23.20 9.92 351 94097 117541 46474073
Dust allergy 23.09 9.92 14 94434 514 46591100
Nasal turbinate hypertrophy 23.06 9.92 13 94435 416 46591198
Lung diffusion test decreased 22.87 9.92 15 94433 633 46590981
Bronchial haemorrhage 22.83 9.92 12 94436 333 46591281
Lipohypertrophy 22.79 9.92 16 94432 756 46590858
Neutrophil count decreased 22.56 9.92 33 94415 43393 46548221
Product use in unapproved indication 22.44 9.92 100 94348 90173 46501441
Influenza B virus test positive 22.17 9.92 12 94436 354 46591260
Arteriosclerosis coronary artery 21.94 9.92 50 94398 8106 46583508
Sputum increased 21.67 9.92 22 94426 1734 46589880
Hyperhidrosis 21.67 9.92 276 94172 89032 46502582
Immune-mediated pancreatitis 21.62 9.92 7 94441 52 46591562
Drug reaction with eosinophilia and systemic symptoms 21.41 9.92 17 94431 29531 46562083
Eosinophilic bronchitis 21.41 9.92 11 94437 291 46591323
Disseminated intravascular coagulation 21.31 9.92 6 94442 18999 46572615
Hepatic function abnormal 21.17 9.92 23 94425 34398 46557216
Multiple organ dysfunction syndrome 20.84 9.92 46 94402 51664 46539950
Headache 20.80 9.92 1174 93274 477178 46114436
Throat clearing 20.73 9.92 12 94436 404 46591210
Cortisol decreased 20.57 9.92 17 94431 1027 46590587
Paranasal sinus discomfort 20.56 9.92 26 94422 2606 46589008
Decreased bronchial secretion 20.45 9.92 7 94441 63 46591551
Heart sounds 20.24 9.92 10 94438 243 46591371
Palmar-plantar erythrodysaesthesia syndrome 20.23 9.92 8 94440 20443 46571171
Restrictive pulmonary disease 20.16 9.92 18 94430 1208 46590406
Hepatic failure 19.82 9.92 23 94425 33393 46558221
Sinus congestion 19.80 9.92 65 94383 13044 46578570
Respiration abnormal 19.79 9.92 34 94414 4487 46587127
Neoplasm progression 19.78 9.92 15 94433 26668 46564946
Suicide attempt 19.77 9.92 52 94396 54984 46536630
Accidental exposure to product 19.65 9.92 9 94439 21072 46570542
Respiratory arrest 19.28 9.92 24 94424 33792 46557822
Exposure during pregnancy 19.18 9.92 134 94314 108078 46483536
Bone marrow failure 19.18 9.92 19 94429 29650 46561964
Septic shock 19.09 9.92 57 94391 57836 46533778
Weight decreased 19.08 9.92 560 93888 210289 46381325
Bronchial obstruction 19.00 9.92 18 94430 1304 46590310
Encephalopathy 18.98 9.92 24 94424 33565 46558049
Conjunctivitis allergic 18.95 9.92 14 94434 717 46590897
Choking 18.93 9.92 48 94400 8328 46583286
Functional residual capacity increased 18.73 9.92 7 94441 83 46591531
Perineal fistula 18.72 9.92 6 94442 43 46591571
Hypotension 18.56 9.92 345 94103 232244 46359370
Seizure 18.26 9.92 160 94288 122894 46468720
Cognitive disorder 18.22 9.92 29 94419 36854 46554760
Dyskinesia 18.15 9.92 19 94429 28906 46562708
Premature baby 18.06 9.92 7 94441 18105 46573509
Bronchial secretion retention 17.84 9.92 15 94433 928 46590686
Bronchitis chronic 17.80 9.92 31 94417 4136 46587478
Acute hepatic failure 17.75 9.92 4 94444 14717 46576897
Intentional self-injury 17.39 9.92 14 94434 24152 46567462
Bradycardia 17.35 9.92 72 94376 66226 46525388
Thyroid atrophy 17.29 9.92 5 94443 24 46591590
Renal failure 17.16 9.92 147 94301 113447 46478167
Oropharyngitis fungal 17.15 9.92 6 94442 58 46591556
Impaired healing 17.12 9.92 30 94418 36713 46554901
Fungal endocarditis 17.12 9.92 9 94439 250 46591364
Product administration error 17.07 9.92 82 94366 19599 46572015
Ascites 16.93 9.92 30 94418 36554 46555060
Sarcoidosis 16.59 9.92 34 94414 5125 46586489
Drug interaction 16.59 9.92 300 94148 202794 46388820
Aspirin-exacerbated respiratory disease 16.47 9.92 13 94435 735 46590879
Peak expiratory flow rate abnormal 16.45 9.92 7 94441 119 46591495
Anaphylactic reaction 16.39 9.92 172 94276 52940 46538674
Otorrhoea 16.20 9.92 17 94431 1393 46590221
Stomatitis 16.17 9.92 77 94371 68220 46523394
Back pain 16.14 9.92 547 93901 209492 46382122
Sepsis 15.97 9.92 187 94261 135827 46455787
Hyperkalaemia 15.96 9.92 51 94397 50658 46540956
Functional residual capacity decreased 15.91 9.92 6 94442 73 46591541
Granuloma 15.89 9.92 28 94420 3770 46587844
Trifascicular block 15.88 9.92 7 94441 130 46591484
Dysmetropsia 15.77 9.92 6 94442 75 46591539
Adrenal suppression 15.71 9.92 14 94434 937 46590677
Pulmonary pain 15.44 9.92 18 94430 1658 46589956
Drug resistance 15.30 9.92 8 94440 17360 46574254
Shock 15.29 9.92 13 94435 21832 46569782
Type 2 diabetes mellitus 15.25 9.92 80 94368 19795 46571819
Plasma cell myeloma 15.24 9.92 43 94405 44435 46547179
Respiratory tract irritation 15.16 9.92 10 94438 426 46591188
Abdominal discomfort 15.11 9.92 215 94233 150950 46440664
Blood test abnormal 15.10 9.92 48 94400 9472 46582142
Pneumocystis jirovecii pneumonia 15.03 9.92 6 94442 15242 46576372
Vital capacity decreased 14.98 9.92 11 94437 558 46591056
Psoriatic arthropathy 14.95 9.92 32 94416 36347 46555267
Peritonitis 14.90 9.92 12 94436 20702 46570912
Sopor 14.89 9.92 11 94437 19817 46571797
Bronchitis bacterial 14.88 9.92 12 94436 700 46590914
Dehydration 14.87 9.92 230 94218 159310 46432304
Blood creatinine increased 14.85 9.92 92 94356 76311 46515303
Chronic sinusitis 14.83 9.92 32 94416 5001 46586613
Exposure to allergen 14.80 9.92 7 94441 154 46591460
Nasal oedema 14.73 9.92 13 94435 859 46590755
Generalised tonic-clonic seizure 14.69 9.92 20 94428 27102 46564512
Poisoning 14.64 9.92 5 94443 13989 46577625
Mucosal inflammation 14.64 9.92 36 94412 38940 46552674
Eczema impetiginous 14.62 9.92 4 94444 15 46591599
Pneumonia aspiration 14.55 9.92 26 94422 31579 46560035
Metastases to liver 14.53 9.92 11 94437 19574 46572040
Nasal mucosal discolouration 14.42 9.92 4 94444 16 46591598
Premature delivery 14.42 9.92 14 94434 22055 46569559
Bronchopulmonary aspergillosis allergic 14.39 9.92 12 94436 734 46590880
Small airways disease 14.22 9.92 4 94444 17 46591597
Allergy to animal 14.17 9.92 11 94437 607 46591007
Investigation 14.15 9.92 17 94431 1617 46589997
Hyperplastic cholecystopathy 14.10 9.92 6 94442 102 46591512
Breast conserving surgery 13.78 9.92 12 94436 779 46590835
Nasal mucosal disorder 13.53 9.92 9 94439 389 46591225
Tobacco abuse 13.42 9.92 11 94437 657 46590957
Chronic respiratory failure 13.26 9.92 17 94431 1727 46589887
Nasal obstruction 13.25 9.92 11 94437 669 46590945
Foetal malnutrition 13.21 9.92 6 94442 120 46591494
Eosinophilia 13.17 9.92 75 94373 19142 46572472
Endometrial ablation 12.97 9.92 11 94437 689 46590925
Acute myeloid leukaemia 12.85 9.92 8 94440 15770 46575844
Myelodysplastic syndrome 12.75 9.92 8 94440 15703 46575911
Infective aneurysm 12.75 9.92 9 94439 429 46591185
Osteonecrosis of jaw 12.74 9.92 32 94416 34370 46557244
Foetal exposure during pregnancy 12.68 9.92 27 94421 30720 46560894
Psoriasis 12.65 9.92 100 94348 78504 46513110
Pericarditis 12.60 9.92 18 94430 23909 46567705
Varicella zoster oesophagitis 12.56 9.92 4 94444 28 46591586
Injection site reaction 12.50 9.92 52 94396 47797 46543817
Drug ineffective for unapproved indication 12.46 9.92 9 94439 16404 46575210
Gait deviation 12.38 9.92 5 94443 74 46591540
Adverse drug reaction 12.36 9.92 47 94401 44315 46547299
Haemoglobin decreased 12.32 9.92 185 94263 128764 46462850
Faecal volume decreased 12.17 9.92 6 94442 145 46591469
Gamma-glutamyltransferase increased 12.17 9.92 29 94419 31711 46559903
Palpitations 12.15 9.92 265 94183 94994 46496620
Muscle spasticity 12.12 9.92 4 94444 11436 46580178
Osteochondritis 12.10 9.92 4 94444 32 46591582
Breast neoplasm 12.08 9.92 14 94434 1281 46590333
Varicella zoster gastritis 11.99 9.92 4 94444 33 46591581
Liver injury 11.85 9.92 9 94439 15992 46575622
Crepitations 11.83 9.92 33 94415 6059 46585555
Sputum abnormal 11.82 9.92 8 94440 356 46591258
Sinus headache 11.75 9.92 28 94420 4672 46586942
Hypothermia 11.67 9.92 5 94443 12178 46579436
Abortion spontaneous 11.67 9.92 47 94401 43599 46548015
Neuroleptic malignant syndrome 11.59 9.92 4 94444 11118 46580496
Illness 11.38 9.92 52 94396 12172 46579442
Stress fracture 11.36 9.92 36 94412 7091 46584523
Gastroenteritis eosinophilic 11.29 9.92 5 94443 94 46591520
Pneumonectomy 11.24 9.92 3 94445 10 46591604
Haemolytic anaemia 11.23 9.92 3 94445 9839 46581775
Blood lactate dehydrogenase increased 11.22 9.92 15 94433 20485 46571129
Symptom recurrence 11.21 9.92 8 94440 388 46591226
Influenza like illness 11.16 9.92 171 94277 57399 46534215
No adverse event 11.07 9.92 34 94414 34197 46557417
Depressed level of consciousness 11.04 9.92 54 94394 47515 46544099
Bronchospasm paradoxical 10.96 9.92 5 94443 101 46591513
Overdose 10.92 9.92 143 94305 101836 46489778
Transplant rejection 10.81 9.92 3 94445 9593 46582021
Tracheobronchitis bacterial 10.81 9.92 3 94445 12 46591602
Cerebral haemorrhage 10.81 9.92 26 94422 28345 46563269
Infusion site erythema 10.75 9.92 37 94411 7605 46584009
Throat tightness 10.69 9.92 75 94373 20564 46571050
Mydriasis 10.65 9.92 4 94444 10549 46581065
FEV1/FVC ratio decreased 10.62 9.92 3 94445 13 46591601
Nasal pruritus 10.62 9.92 7 94441 298 46591316
Peroneal nerve injury 10.51 9.92 4 94444 50 46591564
Candida infection 10.47 9.92 79 94369 22161 46569453
Renal impairment 10.46 9.92 98 94350 74274 46517340
Nausea 10.44 9.92 1225 93223 686229 45905385
Cor pulmonale 10.39 9.92 16 94432 1927 46589687
Drug eruption 10.32 9.92 17 94431 21312 46570302
Blood pressure fluctuation 10.02 9.92 30 94418 30418 46561196
Bacillus infection 9.99 9.92 7 94441 330 46591284
Erythema 9.98 9.92 368 94080 142452 46449162
Ejection fraction decreased 9.95 9.92 13 94435 17924 46573690

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 1647.26 10.81 913 48346 35261 29867958
Chronic obstructive pulmonary disease 635.73 10.81 559 48700 45567 29857652
Wheezing 527.29 10.81 424 48835 30514 29872705
Dyspnoea 398.88 10.81 1325 47934 331970 29571249
Obstructive airways disorder 390.35 10.81 221 49038 8838 29894381
Cough 269.63 10.81 620 48639 125022 29778197
Sputum discoloured 253.54 10.81 150 49109 6518 29896701
Forced expiratory volume decreased 243.38 10.81 115 49144 3135 29900084
Productive cough 228.94 10.81 264 48995 29689 29873530
Blood count abnormal 184.20 10.81 153 49106 11499 29891720
Eosinophilic granulomatosis with polyangiitis 172.14 10.81 69 49190 1246 29901973
Toxicity to various agents 157.43 10.81 48 49211 177135 29726084
Pneumonia 155.61 10.81 1009 48250 333297 29569922
Pulmonary function test decreased 131.10 10.81 84 49175 4211 29899008
Infective pulmonary exacerbation of cystic fibrosis 128.13 10.81 109 49150 8463 29894756
Bronchiectasis 114.19 10.81 83 49176 5121 29898098
Completed suicide 110.64 10.81 16 49243 99476 29803743
Nasal congestion 108.46 10.81 143 49116 18423 29884796
Chest discomfort 107.95 10.81 234 49025 45246 29857973
Lower respiratory tract infection 104.13 10.81 170 49089 26544 29876675
Therapeutic product effect incomplete 102.88 10.81 193 49066 33641 29869578
Asthma-chronic obstructive pulmonary disease overlap syndrome 101.27 10.81 39 49220 630 29902589
Nasal obstruction 100.54 10.81 39 49220 643 29902576
Product quality issue 95.15 10.81 135 49124 18639 29884580
Respiratory tract congestion 86.38 10.81 72 49187 5434 29897785
Blood immunoglobulin E increased 84.88 10.81 46 49213 1684 29901535
Bronchitis 83.51 10.81 193 49066 38932 29864287
Respiratory disorder 78.81 10.81 119 49140 17375 29885844
Sinus pain 75.96 10.81 32 49227 659 29902560
Nasal polyps 74.23 10.81 39 49220 1340 29901879
Emphysema 73.67 10.81 84 49175 9318 29893901
Sinusitis 70.62 10.81 164 49095 33181 29870038
Nasopharyngitis 70.45 10.81 235 49024 58614 29844605
Breath sounds abnormal 68.17 10.81 60 49199 4875 29898344
Middle insomnia 63.86 10.81 62 49197 5711 29897508
Respiratory rate increased 63.76 10.81 76 49183 8839 29894380
Dyspnoea exertional 63.06 10.81 163 49096 35267 29867952
Drug abuse 63.05 10.81 28 49231 82044 29821175
Painful respiration 59.65 10.81 33 49226 1259 29901960
Hypoventilation 59.12 10.81 45 49214 2978 29900241
Malaise 58.68 10.81 472 48787 166490 29736729
Thrombocytopenia 56.72 10.81 86 49173 136958 29766261
Febrile neutropenia 55.65 10.81 56 49203 106637 29796582
Dust allergy 54.99 10.81 22 49237 395 29902824
Sleep disorder due to a general medical condition 54.92 10.81 33 49226 1474 29901745
Mycobacterium avium complex infection 54.44 10.81 41 49218 2670 29900549
Status asthmaticus 52.98 10.81 20 49239 305 29902914
Nasal disorder 51.58 10.81 29 49230 1142 29902077
Sensitivity to weather change 50.83 10.81 31 49228 1423 29901796
Pulmonary mass 50.50 10.81 75 49184 10787 29892432
Heart rate increased 50.26 10.81 159 49100 38562 29864657
Inhalation therapy 50.25 10.81 12 49247 29 29903190
Pulmonary function test abnormal 49.41 10.81 30 49229 1366 29901853
Throat irritation 47.09 10.81 64 49195 8484 29894735
Influenza 45.58 10.81 166 49093 43232 29859987
Body temperature decreased 45.37 10.81 67 49192 9588 29893631
Osteopenia 44.22 10.81 46 49213 4602 29898617
Respiratory tract infection 42.87 10.81 85 49174 15421 29887798
Restrictive pulmonary disease 42.83 10.81 25 49234 1058 29902161
Infective exacerbation of chronic obstructive airways disease 40.78 10.81 27 49232 1431 29901788
Platelet count decreased 40.69 10.81 70 49189 106059 29797160
Oxygen saturation decreased 39.73 10.81 159 49100 43281 29859938
Off label use 39.64 10.81 244 49015 249046 29654173
Asthmatic crisis 39.26 10.81 18 49241 457 29902762
Foetal malformation 38.62 10.81 13 49246 139 29903080
Renal impairment 37.60 10.81 50 49209 84134 29819085
Eosinophil count increased 36.77 10.81 53 49206 7420 29895799
Lower respiratory tract congestion 36.44 10.81 22 49237 991 29902228
Walking aid user 36.18 10.81 25 49234 1422 29901797
Increased viscosity of bronchial secretion 36.13 10.81 14 49245 230 29902989
Blood pressure systolic increased 34.96 10.81 77 49182 15033 29888186
Neutropenia 34.46 10.81 103 49156 128437 29774782
Central obesity 33.55 10.81 17 49242 541 29902678
Mite allergy 33.20 10.81 13 49246 220 29902999
Bronchial hyperreactivity 33.06 10.81 22 49237 1176 29902043
Chest injury 32.78 10.81 23 49236 1341 29901878
Trisomy 18 32.67 10.81 13 49246 230 29902989
Granulomatous rosacea 32.53 10.81 12 49247 171 29903048
Lung diffusion test decreased 32.17 10.81 17 49242 591 29902628
Cystic fibrosis 32.12 10.81 28 49231 2246 29900973
Adrenal suppression 31.53 10.81 17 49242 616 29902603
Pancytopenia 30.89 10.81 58 49201 84994 29818225
Blood pressure increased 30.66 10.81 213 49046 71715 29831504
Rhabdomyolysis 30.22 10.81 36 49223 63544 29839675
Oral candidiasis 29.78 10.81 60 49199 11011 29892208
Nasal discharge discolouration 29.52 10.81 12 49247 225 29902994
Lung hyperinflation 29.40 10.81 18 49241 832 29902387
Intentional overdose 29.04 10.81 16 49243 41465 29861754
Death 28.93 10.81 414 48845 356869 29546350
Cerebral artery thrombosis 28.80 10.81 15 49244 506 29902713
Sputum increased 28.54 10.81 24 49235 1833 29901386
Diarrhoea 28.52 10.81 383 48876 333720 29569499
Brain scan abnormal 28.30 10.81 16 49243 637 29902582
Bronchial wall thickening 27.84 10.81 14 49245 438 29902781
Reversible airways obstruction 27.63 10.81 12 49247 267 29902952
Blood immunoglobulin E decreased 27.13 10.81 8 49251 53 29903166
Rhinitis 24.91 10.81 34 49225 4525 29898694
Sputum purulent 24.89 10.81 13 49246 441 29902778
Bone marrow failure 24.75 10.81 9 49250 29776 29873443
Stress 24.36 10.81 81 49178 20154 29883065
Upper-airway cough syndrome 24.32 10.81 26 49233 2684 29900535
Lung consolidation 24.18 10.81 35 49224 4917 29898302
White blood cell count decreased 24.15 10.81 65 49194 83882 29819337
Aspartate aminotransferase increased 24.14 10.81 42 49217 63380 29839839
Hepatic failure 24.02 10.81 13 49246 34030 29869189
Hepatic haematoma 24.01 10.81 13 49246 475 29902744
Transposition of the great vessels 23.91 10.81 13 49246 479 29902740
Rhonchi 23.84 10.81 21 49238 1708 29901511
Respiratory tract irritation 23.62 10.81 9 49250 141 29903078
Rales 23.48 10.81 40 49219 6460 29896759
Alanine aminotransferase increased 23.31 10.81 55 49204 74221 29828998
Forced vital capacity decreased 23.31 10.81 15 49244 757 29902462
Multiple organ dysfunction syndrome 23.30 10.81 43 49216 63444 29839775
Blood creatinine increased 23.21 10.81 75 49184 91300 29811919
Growth retardation 23.20 10.81 20 49239 1580 29901639
Bronchospasm 23.15 10.81 52 49207 10286 29892933
Conjunctivitis allergic 22.91 10.81 13 49246 521 29902698
Sputum abnormal 22.84 10.81 12 49247 412 29902807
Dysphonia 22.74 10.81 76 49183 18956 29884263
Malignant neoplasm progression 22.31 10.81 54 49205 72233 29830986
Rhinorrhoea 22.30 10.81 80 49179 20674 29882545
Mycotic allergy 22.17 10.81 9 49250 168 29903051
Lung disorder 21.78 10.81 106 49153 31363 29871856
Respiratory symptom 20.86 10.81 14 49245 759 29902460
Blood pressure diastolic decreased 20.76 10.81 37 49222 6194 29897025
Respiratory distress 20.67 10.81 108 49151 32864 29870355
Drug resistance 20.67 10.81 4 49255 20129 29883090
Anaemia 20.50 10.81 231 49028 207761 29695458
Anosmia 20.36 10.81 21 49238 2079 29901140
Sneezing 20.29 10.81 30 49229 4297 29898922
Upper respiratory tract infection 20.07 10.81 94 49165 27382 29875837
Necrotising oesophagitis 20.04 10.81 11 49248 413 29902806
Hepatotoxicity 19.96 10.81 3 49256 18142 29885077
Sepsis 19.87 10.81 150 49109 146245 29756974
Lipohypertrophy 19.80 10.81 10 49249 316 29902903
Product use in unapproved indication 19.76 10.81 59 49200 73634 29829585
Nasal inflammation 19.57 10.81 9 49250 230 29902989
Bone deformity 19.37 10.81 6 49253 48 29903171
Eosinophilia 19.36 10.81 80 49179 22080 29881139
Weight increased 19.20 10.81 198 49061 74715 29828504
Cushingoid 19.11 10.81 22 49237 2465 29900754
Renal failure 19.02 10.81 129 49130 128837 29774382
Coma uraemic 18.95 10.81 6 49253 52 29903167
Carcinoid tumour of the gastrointestinal tract 18.95 10.81 6 49253 52 29903167
Aortic aneurysm 18.75 10.81 36 49223 6377 29896842
Aspirin-exacerbated respiratory disease 18.68 10.81 10 49249 357 29902862
Alveolar bone resorption 18.31 10.81 5 49254 24 29903195
Throat tightness 18.19 10.81 38 49221 7154 29896065
Seasonal allergy 18.17 10.81 30 49229 4723 29898496
Atopy 18.12 10.81 7 49252 114 29903105
Leukopenia 18.09 10.81 41 49218 56118 29847101
Neuropathy peripheral 17.78 10.81 58 49201 70417 29832802
Spirometry abnormal 17.68 10.81 9 49250 289 29902930
Hypopnoea 17.64 10.81 15 49244 1163 29902056
Forced expiratory flow decreased 17.58 10.81 7 49252 124 29903095
Product complaint 17.48 10.81 33 49226 5773 29897446
Ascites 17.43 10.81 20 49239 35901 29867318
Blood test abnormal 17.38 10.81 32 49227 5493 29897726
Malpositioned teeth 17.24 10.81 5 49254 31 29903188
Neutrophil count decreased 17.19 10.81 27 49232 42427 29860792
Sinus congestion 16.98 10.81 29 49230 4693 29898526
Bronchopulmonary aspergillosis allergic 16.92 10.81 9 49250 317 29902902
Eye infection 16.76 10.81 22 49237 2820 29900399
Drug-induced liver injury 16.73 10.81 7 49252 21267 29881952
Weight decreased 16.58 10.81 344 48915 150577 29752642
Peak expiratory flow rate decreased 16.58 10.81 7 49252 145 29903074
Bronchial disorder 16.55 10.81 13 49246 901 29902318
Cortisol decreased 16.50 10.81 13 49246 905 29902314
Extra dose administered 16.49 10.81 22 49237 2864 29900355
Nausea 16.38 10.81 368 48891 296589 29606630
Haemoptysis 16.28 10.81 97 49162 30981 29872238
Hepatocellular injury 16.19 10.81 11 49248 25460 29877759
Electrocardiogram QT shortened 15.98 10.81 7 49252 159 29903060
Loss of personal independence in daily activities 15.96 10.81 74 49185 21461 29881758
Polyp 15.83 10.81 23 49236 3243 29899976
Crepitations 15.69 10.81 22 49237 3002 29900217
Tubulointerstitial nephritis 15.57 10.81 5 49254 17886 29885333
Cytomegalovirus infection 15.35 10.81 10 49249 23664 29879555
Hot flush 15.27 10.81 56 49203 14624 29888595
Flour sensitivity 15.15 10.81 5 49254 50 29903169
Proteinuria 14.99 10.81 4 49255 16141 29887078
Rhinitis perennial 14.83 10.81 6 49253 111 29903108
Drug reaction with eosinophilia and systemic symptoms 14.78 10.81 15 49244 28473 29874746
Mucosal inflammation 14.77 10.81 17 49242 30477 29872742
Pneumocystis jirovecii pneumonia 14.52 10.81 5 49254 17115 29886104
Food allergy 14.50 10.81 12 49247 896 29902323
Acute respiratory failure 14.40 10.81 82 49177 25768 29877451
Cholestasis 14.29 10.81 12 49247 24938 29878281
Diffuse panbronchiolitis 14.16 10.81 3 49256 3 29903216
Aphonia 14.12 10.81 21 49238 3023 29900196
Chronic sinusitis 14.06 10.81 15 49244 1544 29901675
Neoplasm progression 14.06 10.81 6 49253 18017 29885202
Hepatic function abnormal 14.02 10.81 30 49229 41915 29861304
Peritonitis 13.90 10.81 9 49250 21366 29881853
Dehydration 13.87 10.81 133 49126 123406 29779813
Infective exacerbation of bronchiectasis 13.68 10.81 9 49250 472 29902747
Throat clearing 13.52 10.81 7 49252 233 29902986
Rhinitis allergic 13.47 10.81 20 49239 2874 29900345
Respiration abnormal 13.38 10.81 19 49240 2623 29900596
Nightmare 13.36 10.81 47 49212 12029 29891190
Spleen congestion 13.10 10.81 8 49251 368 29902851
Hypersensitivity 12.99 10.81 141 49118 53887 29849332
Increased upper airway secretion 12.85 10.81 15 49244 1705 29901514
Plasma cell myeloma 12.80 10.81 45 49214 53417 29849802
Neurotoxicity 12.75 10.81 3 49256 13179 29890040
Disease progression 12.73 10.81 78 49181 79796 29823423
Hyperbilirubinaemia 12.65 10.81 6 49253 16936 29886283
Pseudomonas infection 12.65 10.81 42 49217 10440 29892779
Acute myeloid leukaemia 12.52 10.81 7 49252 17999 29885220
Cerebral infarction 12.45 10.81 15 49244 26358 29876861
Drug intolerance 12.33 10.81 36 49223 45255 29857964
Meralgia paraesthetica 12.20 10.81 6 49253 179 29903040
Deformity thorax 12.12 10.81 4 49255 40 29903179
Dyspnoea at rest 12.12 10.81 18 49241 2588 29900631
Bronchitis bacterial 12.12 10.81 10 49249 744 29902475
Alpha-1 antitrypsin deficiency 12.09 10.81 3 49256 9 29903210
Somnambulism 11.90 10.81 20 49239 3194 29900025
Hypovolaemic shock 11.65 10.81 30 49229 6470 29896749
Acute respiratory distress syndrome 11.46 10.81 13 49246 23459 29879760
Depressed level of consciousness 11.44 10.81 29 49230 38193 29865026
Hypohidrosis 11.42 10.81 6 49253 206 29903013
Intentional product misuse 11.41 10.81 25 49234 34642 29868577
Eosinophilic bronchitis 11.39 10.81 4 49255 49 29903170
Delirium 11.27 10.81 32 49227 40599 29862620
Carcinoid tumour of the stomach 11.25 10.81 4 49255 51 29903168
Eye disorder 11.19 10.81 33 49226 7701 29895518
Vomiting 11.10 10.81 276 48983 219542 29683677
Type 2 diabetes mellitus 10.99 10.81 48 49211 13574 29889645
Hypokalaemic syndrome 10.89 10.81 3 49256 15 29903204
Ileus 10.89 10.81 6 49253 15549 29887670
Epidural lipomatosis 10.82 10.81 6 49253 230 29902989

Pharmacologic Action:

SourceCodeDescription
ATC R03AC12 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Selective beta-2-adrenoreceptor agonists
ATC R03AK06 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK12 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
FDA MoA N0000009922 Adrenergic beta2-Agonists
FDA EPC N0000175779 beta2-Adrenergic Agonist
MeSH PA D018663 Adrenergic Agents
MeSH PA D000322 Adrenergic Agonists
MeSH PA D058666 Adrenergic beta-2 Receptor Agonists
MeSH PA D000318 Adrenergic beta-Agonists
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D001993 Bronchodilator Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D019141 Respiratory System Agents
CHEBI has role CHEBI:35522 beta-adrenergic receptor agonist
CHEBI has role CHEBI:35523 bronchodilator agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Pulmonary emphysema indication 87433001
Non-allergic asthma indication 266361008 DOID:9360
Allergic asthma indication 389145006 DOID:9415
Adjunct Therapy to Achieve Long-term Asthma Control indication
Bronchospasm Prevention with COPD indication
Exercise-Induced Bronchospasm Prevention indication
COPD Associated with Chronic Bronchitis indication
Mycosis contraindication 3218000 DOID:1564
Disease caused by parasite contraindication 17322007
Glaucoma contraindication 23986001 DOID:1686
Acute tuberculosis contraindication 25629007
Hypertensive disorder contraindication 38341003 DOID:10763
Hypokalemia contraindication 43339004
Conduction disorder of the heart contraindication 44808001
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
Hyperglycemia contraindication 80394007 DOID:4195
Thyrotoxicosis contraindication 90739004 DOID:7997
Bilateral cataracts contraindication 95722004
Prolonged QT interval contraindication 111975006
Seizure disorder contraindication 128613002
Ophthalmic herpes simplex contraindication 186542001
Exacerbation of asthma contraindication 281239006
Osteopenia contraindication 312894000
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Congenital long QT syndrome contraindication 442917000
Uncontrolled Bacterial Infections contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.07 acidic
pKa2 9.28 Basic

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
Beta-2 adrenergic receptor GPCR AGONIST Ki 9.41 CHEMBL CHEMBL
Aldehyde oxidase Enzyme IC50 5.00 WOMBAT-PK
Beta-1 adrenergic receptor GPCR Ki 6.10 CHEMBL
Beta-3 adrenergic receptor GPCR EC50 6 CHEMBL
D(3) dopamine receptor GPCR Ki 5.98 CHEMBL
Beta-2 adrenergic receptor GPCR EC50 7.50 CHEMBL

External reference:

IDSource
4023955 VUID
N0000021960 NUI
D00687 KEGG_DRUG
94749-08-3 SECONDARY_CAS_RN
4020873 VANDF
4023955 VANDF
C0245531 UMLSCUI
CHEBI:9011 CHEBI
K5Y PDB_CHEM_ID
CHEMBL1263 ChEMBL_ID
CHEMBL1082607 ChEMBL_ID
D000068299 MESH_DESCRIPTOR_UI
559 IUPHAR_LIGAND_ID
5578 INN_ID
DB00938 DRUGBANK_ID
2I4BC502BT UNII
5152 PUBCHEM_CID
203159 RXNORM
1605 MMSL
21564 MMSL
5440 MMSL
d03759 MMSL
004036 NDDF
004037 NDDF
108605008 SNOMEDCT_US
108606009 SNOMEDCT_US
372515005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0054-0326 POWDER 50 ug RESPIRATORY (INHALATION) ANDA 29 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0054-0327 POWDER 50 ug RESPIRATORY (INHALATION) ANDA 29 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3607 POWDER, METERED 14 ug RESPIRATORY (INHALATION) NDA AUTHORIZED GENERIC 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3608 POWDER, METERED 14 ug RESPIRATORY (INHALATION) NDA AUTHORIZED GENERIC 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3609 POWDER, METERED 14 ug RESPIRATORY (INHALATION) NDA AUTHORIZED GENERIC 28 sections
SEREVENTDISKUS HUMAN PRESCRIPTION DRUG LABEL 1 0173-0520 POWDER, METERED 50 ug RESPIRATORY (INHALATION) NDA 29 sections
SEREVENTDISKUS HUMAN PRESCRIPTION DRUG LABEL 1 0173-0521 POWDER, METERED 50 ug RESPIRATORY (INHALATION) NDA 29 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0695 POWDER 50 ug RESPIRATORY (INHALATION) NDA 27 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0696 POWDER 50 ug RESPIRATORY (INHALATION) NDA 27 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0697 POWDER 50 ug RESPIRATORY (INHALATION) NDA 27 sections
ADVAIR HFA HUMAN PRESCRIPTION DRUG LABEL 2 0173-0715 AEROSOL, METERED 21 ug RESPIRATORY (INHALATION) NDA 28 sections
ADVAIR HFA HUMAN PRESCRIPTION DRUG LABEL 2 0173-0716 AEROSOL, METERED 21 ug RESPIRATORY (INHALATION) NDA 28 sections
ADVAIR HFA HUMAN PRESCRIPTION DRUG LABEL 2 0173-0717 AEROSOL, METERED 21 ug RESPIRATORY (INHALATION) NDA 28 sections
Wixela Inhub HUMAN PRESCRIPTION DRUG LABEL 2 0378-9320 POWDER 50 ug RESPIRATORY (INHALATION) ANDA 30 sections
Wixela Inhub HUMAN PRESCRIPTION DRUG LABEL 2 0378-9321 POWDER 50 ug RESPIRATORY (INHALATION) ANDA 30 sections
Wixela Inhub HUMAN PRESCRIPTION DRUG LABEL 2 0378-9322 POWDER 50 ug RESPIRATORY (INHALATION) ANDA 30 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 21695-196 POWDER 50 ug RESPIRATORY (INHALATION) NDA 30 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 21695-197 POWDER 50 ug RESPIRATORY (INHALATION) NDA 30 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 21695-361 POWDER 50 ug RESPIRATORY (INHALATION) NDA 30 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 33261-873 POWDER 50 ug RESPIRATORY (INHALATION) NDA 29 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 33261-874 POWDER 50 ug RESPIRATORY (INHALATION) NDA 29 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 50090-0731 POWDER 0.05 mg RESPIRATORY (INHALATION) NDA 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 50090-3387 POWDER, METERED 14 ug RESPIRATORY (INHALATION) NDA AUTHORIZED GENERIC 28 sections
Fluticasone Propionate and SalmeterolDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 50090-4211 POWDER 50 ug RESPIRATORY (INHALATION) NDA authorized generic 29 sections
Fluticasone Propionate and SalmeterolDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 50090-4213 POWDER 50 ug RESPIRATORY (INHALATION) NDA authorized generic 29 sections
Fluticasone Propionate and SalmeterolDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 50090-4214 POWDER 50 ug RESPIRATORY (INHALATION) NDA authorized generic 29 sections
ADVAIR DISKUS HUMAN PRESCRIPTION DRUG LABEL 2 54868-4516 POWDER 50 ug RESPIRATORY (INHALATION) NDA 30 sections
ADVAIR DISKUS HUMAN PRESCRIPTION DRUG LABEL 2 54868-4517 POWDER 50 ug RESPIRATORY (INHALATION) NDA 30 sections
ADVAIR DISKUS HUMAN PRESCRIPTION DRUG LABEL 2 54868-4518 POWDER 50 ug RESPIRATORY (INHALATION) NDA 30 sections
AirDuo Digihaler HUMAN PRESCRIPTION DRUG LABEL 2 59310-111 POWDER, METERED 14 ug RESPIRATORY (INHALATION) NDA 28 sections