formoterol ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
bronchodilators, phenethylamine derivatives 1239 73573-87-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • eformoterol
  • formoterol
  • formoterol fumarate
  • formoterol fumarate dihydrate
  • formoterol fumarate hydrate
An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
  • Molecular weight: 344.41
  • Formula: C19H24N2O4
  • CLOGP: 1.26
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 4
  • TPSA: 90.82
  • ALOGS: -3.92
  • ROTB: 8

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
24 mcg Inhal.aerosol
24 mcg Inhal.powder
0.16 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.66 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 8 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.00 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
Feb. 16, 2001 FDA NOVARTIS
June 18, 2019 PMDA AstraZeneca K.K.
April 28, 2014 EMA Teva Pharma B.V.

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 978.79 13.40 655 29187 112115 56150110
Product quality issue 649.81 13.40 323 29519 31413 56230812
Dyspnoea 486.00 13.40 1005 28837 591572 55670653
Wheezing 332.97 13.40 293 29549 74733 56187492
Chronic obstructive pulmonary disease 262.21 13.40 228 29614 57187 56205038
Obstructive airways disorder 253.91 13.40 141 29701 17141 56245084
Cough 231.59 13.40 458 29384 259503 56002722
No adverse event 169.11 13.40 146 29696 36228 56225997
Chest discomfort 169.09 13.40 234 29608 98623 56163602
Polycystic ovaries 150.14 13.40 59 29783 3255 56258970
Sleep apnoea syndrome 138.46 13.40 113 29729 25948 56236277
Nasal polyps 137.01 13.40 55 29787 3210 56259015
Product dose omission issue 122.44 13.40 308 29534 204445 56057780
Gastrooesophageal reflux disease 118.88 13.40 181 29661 83076 56179149
Emphysema 118.76 13.40 71 29771 9905 56252320
Productive cough 105.02 13.40 139 29703 56093 56206132
Sputum increased 103.96 13.40 40 29802 2084 56260141
Rheumatoid arthritis 103.34 13.40 37 29805 382567 55879658
Salpingo-oophorectomy unilateral 98.11 13.40 29 29813 663 56261562
Sinusitis fungal 93.41 13.40 34 29808 1516 56260709
Respiratory symptom 90.12 13.40 39 29803 2751 56259474
Candida infection 89.98 13.40 88 29754 25579 56236646
Rhinitis allergic 89.82 13.40 56 29786 8418 56253807
Sensitisation 86.10 13.40 36 29806 2332 56259893
Off label use 85.20 13.40 102 29740 556078 55706147
Asthmatic crisis 82.97 13.40 32 29810 1678 56260547
Embolism venous 82.89 13.40 37 29805 2811 56259414
Ejection fraction 82.88 13.40 32 29810 1683 56260542
Eosinophilic granulomatosis with polyangiitis 80.57 13.40 33 29809 2028 56260197
Eczema 79.47 13.40 83 29759 26070 56236155
Systemic lupus erythematosus 78.92 13.40 4 29838 180074 56082151
Hyper IgE syndrome 78.47 13.40 22 29820 414 56261811
Skin candida 78.14 13.40 29 29813 1367 56260858
Blood test abnormal 75.50 13.40 59 29783 12725 56249500
Joint swelling 70.12 13.40 33 29809 289767 55972458
Dysphonia 68.21 13.40 97 29745 41850 56220375
Female genital tract fistula 66.90 13.40 37 29805 4455 56257770
Bronchospasm 65.02 13.40 59 29783 15610 56246615
Mycobacterium avium complex infection 63.99 13.40 31 29811 2838 56259387
Treatment failure 63.05 13.40 8 29834 170384 56091841
Restrictive pulmonary disease 61.59 13.40 25 29817 1501 56260724
Alopecia 60.12 13.40 41 29801 293417 55968808
Arthropathy 60.03 13.40 16 29826 200259 56061966
Diastolic dysfunction 59.06 13.40 37 29805 5608 56256617
Drug intolerance 58.36 13.40 34 29808 264784 55997441
Dyspnoea exertional 57.93 13.40 104 29738 54585 56207640
Sputum discoloured 57.71 13.40 53 29789 14239 56247986
Hepatic enzyme increased 54.67 13.40 12 29830 171372 56090853
Chronic sinusitis 54.59 13.40 41 29801 8337 56253888
Toxicity to various agents 53.64 13.40 26 29816 224538 56037687
Pain 52.93 13.40 178 29664 663006 55599219
Pneumonia 51.83 13.40 381 29461 406717 55855508
Pulmonary mass 51.79 13.40 59 29783 20411 56241814
Diverticulum 50.55 13.40 44 29798 11022 56251203
Oedema peripheral 48.95 13.40 200 29642 171054 56091171
Hypothyroidism 48.85 13.40 79 29763 38117 56224108
Hiatus hernia 48.63 13.40 56 29786 19596 56242629
Sleep disorder due to a general medical condition 47.39 13.40 39 29803 9051 56253174
Bronchiectasis 47.33 13.40 43 29799 11391 56250834
Product use issue 45.24 13.40 21 29821 186020 56076205
Product container issue 44.87 13.40 20 29822 1514 56260711
Abdominal discomfort 44.32 13.40 49 29793 277225 55985000
Neurosensory hypoacusis 43.35 13.40 12 29830 215 56262010
Pericarditis 43.11 13.40 4 29838 108919 56153306
Infusion related reaction 43.01 13.40 29 29813 208902 56053323
Nephrectomy 42.62 13.40 18 29824 1195 56261030
Pulmonary function test decreased 41.29 13.40 25 29817 3566 56258659
Tricuspid valve incompetence 40.15 13.40 42 29800 13211 56249014
Swelling 39.84 13.40 41 29801 239730 56022495
White blood cell count decreased 39.81 13.40 9 29833 125981 56136244
Arthralgia 39.70 13.40 135 29707 501534 55760691
Hysterectomy 38.92 13.40 34 29808 8557 56253668
Full blood count abnormal 36.97 13.40 57 29785 26405 56235820
Facial nerve disorder 36.55 13.40 13 29829 542 56261683
Intentional product use issue 36.12 13.40 5 29837 99728 56162497
CFTR gene mutation 36.09 13.40 9 29833 105 56262120
Iron deficiency anaemia 36.08 13.40 46 29796 17873 56244352
Rhinitis 35.87 13.40 33 29809 8883 56253342
Glossodynia 35.86 13.40 18 29824 152440 56109785
Musculoskeletal stiffness 35.83 13.40 19 29823 155988 56106237
Drug ineffective 35.77 13.40 314 29528 918675 55343550
Fatigue 35.47 13.40 259 29583 788293 55473932
Feeling jittery 34.40 13.40 37 29805 12009 56250216
Peripheral swelling 33.77 13.40 45 29797 234681 56027544
Burning sensation 33.01 13.40 77 29765 48619 56213606
Discomfort 32.94 13.40 17 29825 141744 56120481
Therapeutic product effect decreased 32.93 13.40 25 29817 169427 56092798
Product taste abnormal 32.16 13.40 17 29825 1871 56260354
Pulmonary embolism 32.09 13.40 127 29715 106997 56155228
Heart rate increased 31.94 13.40 107 29735 83166 56179059
Lipohypertrophy 31.43 13.40 12 29830 612 56261613
Respiratory tract infection 31.27 13.40 63 29779 36008 56226217
Transient ischaemic attack 30.74 13.40 60 29782 33517 56228708
Dyslipidaemia 30.52 13.40 26 29816 6327 56255898
Bronchopulmonary aspergillosis allergic 30.38 13.40 15 29827 1431 56260794
Pulmonary congestion 30.31 13.40 40 29802 16075 56246150
Urinary tract discomfort 30.26 13.40 10 29832 333 56261892
Drug hypersensitivity 29.27 13.40 64 29778 275141 55987084
Increased bronchial secretion 28.88 13.40 15 29827 1592 56260633
Febrile neutropenia 28.77 13.40 10 29832 105535 56156690
Peak expiratory flow rate decreased 28.05 13.40 11 29831 603 56261622
Impaired healing 27.84 13.40 6 29836 86835 56175390
Congenital naevus 27.27 13.40 8 29834 178 56262047
Bronchitis chronic 27.06 13.40 20 29822 3968 56258257
Throat tightness 26.83 13.40 45 29797 22362 56239863
Peripheral vascular disorder 26.62 13.40 23 29819 5702 56256523
Oropharyngeal pain 26.44 13.40 101 29741 83687 56178538
Swollen tongue 26.33 13.40 53 29789 30271 56231954
Blood electrolytes abnormal 26.13 13.40 12 29830 974 56261251
Nervous system disorder 25.90 13.40 38 29804 16851 56245374
Limb injury 25.71 13.40 44 29798 22226 56239999
Increased upper airway secretion 25.69 13.40 18 29824 3286 56258939
Osteoporosis 25.65 13.40 73 29769 51979 56210246
Angioplasty 25.58 13.40 13 29829 1319 56260906
Skin lesion 25.42 13.40 50 29792 28085 56234140
Diarrhoea 25.26 13.40 217 29625 638290 55623935
Cardiac disorder 25.24 13.40 67 29775 45820 56216405
Alveolar osteitis 25.21 13.40 10 29832 565 56261660
Breast neoplasm 25.18 13.40 13 29829 1363 56260862
Underdose 24.92 13.40 45 29797 23712 56238513
Throat irritation 24.73 13.40 54 29788 32629 56229596
Anaphylactic reaction 24.60 13.40 78 29764 58917 56203308
Coronary artery disease 24.59 13.40 52 29790 30744 56231481
Breath sounds abnormal 24.56 13.40 27 29815 8980 56253245
Hypomagnesaemia 24.49 13.40 46 29796 24969 56237256
Incorrect dose administered 24.26 13.40 72 29770 52475 56209750
Psoriatic arthropathy 23.95 13.40 5 29837 74003 56188222
Drug abuse 23.09 13.40 4 29838 67606 56194619
Circumstance or information capable of leading to medication error 22.74 13.40 17 29825 3431 56258794
Infection 22.59 13.40 45 29797 200161 56062064
Carpal tunnel syndrome 22.48 13.40 37 29805 18107 56244118
Therapy partial responder 22.39 13.40 24 29818 7761 56254464
Lung neoplasm malignant 22.26 13.40 36 29806 17360 56244865
Pharyngeal oedema 21.99 13.40 31 29811 13254 56248971
Female reproductive neoplasm 21.98 13.40 5 29837 38 56262187
Middle insomnia 21.87 13.40 28 29814 10922 56251303
Hypertension 21.62 13.40 211 29631 244067 56018158
Tunnel vision 21.48 13.40 10 29832 837 56261388
Choking 21.19 13.40 25 29817 8972 56253253
Disease recurrence 21.07 13.40 42 29800 23818 56238407
Palpitations 20.68 13.40 106 29736 99566 56162659
Bronchitis 20.30 13.40 115 29727 112196 56150029
Allergic sinusitis 20.28 13.40 9 29833 674 56261551
Renal disorder 20.26 13.40 47 29795 29558 56232667
Neutropenic sepsis 20.22 13.40 32 29810 15153 56247072
Device malfunction 20.12 13.40 33 29809 16103 56246122
Fungal infection 20.03 13.40 50 29792 32943 56229282
Disease progression 19.81 13.40 16 29826 105157 56157068
Ear congestion 19.65 13.40 13 29829 2162 56260063
Carnitine deficiency 19.64 13.40 6 29836 154 56262071
Bordetella test positive 19.63 13.40 3 29839 0 56262225
Animal scratch 19.28 13.40 10 29832 1058 56261167
Ejection fraction abnormal 19.00 13.40 10 29832 1090 56261135
Kyphosis 18.98 13.40 13 29829 2289 56259936
Restless legs syndrome 18.93 13.40 33 29809 16914 56245311
Psoriasis 18.87 13.40 13 29829 92679 56169546
Infective exacerbation of chronic obstructive airways disease 18.83 13.40 10 29832 1111 56261114
Lip pruritus 18.78 13.40 9 29833 804 56261421
Macrocytosis 18.66 13.40 13 29829 2353 56259872
Device ineffective 18.47 13.40 6 29836 189 56262036
Pancreatitis relapsing 18.37 13.40 9 29833 844 56261381
Respiratory tract congestion 18.25 13.40 31 29811 15560 56246665
Oligohydramnios 18.16 13.40 19 29823 5975 56256250
Foreign body aspiration 18.03 13.40 6 29836 204 56262021
Intentional overdose 17.64 13.40 7 29835 68110 56194115
Spirometry abnormal 17.42 13.40 6 29836 227 56261998
Tubulointerstitial nephritis and uveitis syndrome 17.37 13.40 6 29836 229 56261996
Condition aggravated 17.04 13.40 110 29732 344788 55917437
Deep vein thrombosis 16.77 13.40 83 29759 76894 56185331
Depression 16.62 13.40 157 29685 179960 56082265
Oedema mouth 16.61 13.40 12 29830 2298 56259927
Bladder pain 16.55 13.40 11 29831 1843 56260382
Stomatitis 16.52 13.40 24 29818 120786 56141439
Urinary retention 16.47 13.40 42 29800 28032 56234193
Forced expiratory volume decreased 16.37 13.40 16 29826 4644 56257581
Mobility decreased 16.34 13.40 17 29825 98974 56163251
Dysphagia 16.20 13.40 86 29756 81861 56180364
Respiratory disorder 16.12 13.40 47 29795 33910 56228315
Rales 16.06 13.40 24 29818 10816 56251409
Myocardial infarction 16.06 13.40 94 29748 92776 56169449
Blood immunoglobulin E increased 15.87 13.40 13 29829 2996 56259229
Gastrointestinal disorder 15.79 13.40 22 29820 112680 56149545
Crepitations 15.78 13.40 19 29823 6965 56255260
Hypotension 15.59 13.40 74 29768 250434 56011791
Malignant neoplasm progression 15.41 13.40 10 29832 73577 56188648
Abscess 15.10 13.40 28 29814 15053 56247172
Eosinophilia 14.99 13.40 33 29809 20044 56242181
Haemoptysis 14.82 13.40 39 29803 26521 56235704
Irritable bowel syndrome 14.76 13.40 9 29833 68449 56193776
Blister 14.52 13.40 22 29820 108865 56153360
Presbyacusis 14.42 13.40 12 29830 2826 56259399
Neutropenia 14.28 13.40 40 29802 158127 56104098
Mouth ulceration 14.05 13.40 41 29801 29599 56232626
Haemorrhage 13.87 13.40 63 29779 56334 56205891
Hypoaesthesia oral 13.74 13.40 23 29819 11408 56250817
Platelet count decreased 13.71 13.40 22 29820 106361 56155864
Left ventricular hypertrophy 13.69 13.40 15 29827 4969 56257256
Nasal inflammation 13.60 13.40 6 29836 443 56261782
Long QT syndrome 13.58 13.40 12 29830 3064 56259161
Polymyalgia rheumatica 13.56 13.40 12 29830 3070 56259155
Plasma cell myeloma 13.45 13.40 4 29838 46642 56215583
Wound complication 13.41 13.40 12 29830 3116 56259109

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 553.03 13.67 317 16068 42294 31638665
Product quality issue 407.28 13.67 188 16197 15923 31665036
Chronic obstructive pulmonary disease 293.53 13.67 218 16167 44948 31636011
Dyspnoea 271.25 13.67 565 15820 342914 31338045
No adverse event 157.88 13.67 108 16277 19517 31661442
Nasal obstruction 155.81 13.67 40 16345 544 31680415
Wheezing 147.63 13.67 133 16252 35853 31645106
Sinus pain 117.85 13.67 33 16352 635 31680324
Asthma-chronic obstructive pulmonary disease overlap syndrome 106.65 13.67 33 16352 909 31680050
Eosinophilic granulomatosis with polyangiitis 92.58 13.67 34 16351 1597 31679362
Emphysema 91.04 13.67 57 16328 8861 31672098
Cough 89.73 13.67 208 16177 134606 31546353
Pulmonary function test decreased 85.86 13.67 43 16342 4342 31676617
Throat irritation 79.01 13.67 53 16332 9261 31671698
Mycobacterium avium complex infection 76.20 13.67 33 16352 2393 31678566
Product dose omission issue 71.38 13.67 164 16221 105422 31575537
Bronchiectasis 71.27 13.67 46 16339 7534 31673425
Chest discomfort 67.82 13.67 104 16281 49265 31631694
Sputum discoloured 63.41 13.67 41 16344 6735 31674224
Hepatic vein dilatation 62.42 13.67 16 16369 216 31680743
Eosinophil count 60.50 13.67 14 16371 119 31680840
Respiratory disorder 59.63 13.67 59 16326 17841 31663118
Vocal cord dysfunction 57.76 13.67 14 16371 148 31680811
Osteopenia 54.43 13.67 32 16353 4439 31676520
Liver palpable 54.09 13.67 15 16370 278 31680681
Lung consolidation 50.92 13.67 33 16352 5440 31675519
Suffocation feeling 48.86 13.67 16 16369 531 31680428
Obstructive airways disorder 48.34 13.67 45 16340 12619 31668340
Atrial enlargement 46.91 13.67 14 16371 340 31680619
Toxicity to various agents 44.65 13.67 19 16366 181468 31499491
Ventricular enlargement 43.18 13.67 14 16371 450 31680509
Nasal congestion 41.61 13.67 52 16333 20329 31660630
Inferior vena cava dilatation 41.55 13.67 15 16370 670 31680289
Pulmonary mass 40.90 13.67 39 16346 11267 31669692
Hangover 39.68 13.67 16 16369 969 31679990
Dyspnoea at rest 39.67 13.67 24 16361 3507 31677452
Panic reaction 37.72 13.67 17 16368 1355 31679604
Sputum increased 36.10 13.67 19 16366 2126 31678833
Sleep disorder due to a general medical condition 35.01 13.67 23 16362 3879 31677080
Chest pain 33.27 13.67 134 16251 116823 31564136
Bronchial hyperreactivity 30.75 13.67 15 16370 1430 31679529
Bronchial obstruction 30.60 13.67 15 16370 1445 31679514
Bronchospasm 29.79 13.67 31 16354 9941 31671018
Full blood count abnormal 29.13 13.67 39 16346 16308 31664651
Forced expiratory volume decreased 27.82 13.67 18 16367 2959 31678000
Toxic neuropathy 26.61 13.67 10 16375 501 31680458
Stridor 26.49 13.67 16 16369 2331 31678628
Fungal oesophagitis 26.40 13.67 9 16376 339 31680620
Weaning failure 25.43 13.67 8 16377 233 31680726
Product prescribing error 25.02 13.67 40 16345 19602 31661357
Product container issue 24.64 13.67 10 16375 616 31680343
Foreign body aspiration 24.07 13.67 7 16378 155 31680804
Oedema mouth 23.96 13.67 12 16373 1211 31679748
Underdose 23.88 13.67 31 16354 12576 31668383
Heart rate irregular 23.80 13.67 33 16352 14256 31666703
Drug abuse 23.52 13.67 8 16377 87750 31593209
Platelet count decreased 23.47 13.67 14 16371 110421 31570538
Nasal polyps 23.44 13.67 14 16371 1999 31678960
Pneumonia 23.29 13.67 270 16115 335042 31345917
Rales 22.54 13.67 25 16360 8614 31672345
Palpitations 22.52 13.67 53 16332 34530 31646429
Oedema 22.24 13.67 60 16325 42501 31638458
Neutropenia 22.08 13.67 24 16361 140340 31540619
Respiratory tract haemorrhage 21.69 13.67 11 16374 1140 31679819
Cockroach allergy 21.56 13.67 5 16380 43 31680916
Spontaneous haemorrhage 21.10 13.67 7 16378 242 31680717
Adrenal cortex necrosis 20.73 13.67 4 16381 12 31680947
Breath sounds abnormal 20.64 13.67 20 16365 5892 31675067
Cardiac failure chronic 20.56 13.67 22 16363 7281 31673678
Bronchial disorder 20.04 13.67 11 16374 1338 31679621
Orthostatic intolerance 19.72 13.67 9 16376 739 31680220
Necrotising ulcerative gingivostomatitis 19.34 13.67 5 16380 70 31680889
Product taste abnormal 19.23 13.67 10 16375 1091 31679868
Diarrhoea 18.95 13.67 106 16279 352303 31328656
Nasal turbinate hypertrophy 18.72 13.67 5 16380 80 31680879
Dysphonia 18.53 13.67 36 16349 20555 31660404
Therapeutic product effect incomplete 18.39 13.67 57 16328 43639 31637320
Circumstance or information capable of leading to medication error 18.28 13.67 11 16374 1592 31679367
Increased upper airway secretion 18.00 13.67 11 16374 1637 31679322
Oedema peripheral 17.66 13.67 107 16278 109732 31571227
Laryngeal cryptococcosis 17.63 13.67 3 16382 3 31680956
Death 17.51 13.67 112 16273 360457 31320502
Pulmonary congestion 17.31 13.67 27 16358 12956 31668003
Complicated appendicitis 16.70 13.67 4 16381 40 31680919
Nocturnal dyspnoea 16.34 13.67 7 16378 494 31680465
Aphonia 16.10 13.67 13 16372 3012 31677947
Rebound effect 15.98 13.67 12 16373 2501 31678458
Aortic dissection 15.94 13.67 12 16373 2510 31678449
Paradoxical drug reaction 15.72 13.67 13 16372 3116 31677843
Coronary artery stenosis 15.55 13.67 21 16364 8849 31672110
Product use in unapproved indication 15.54 13.67 17 16368 99154 31581805
Infective exacerbation of chronic obstructive airways disease 15.16 13.67 10 16375 1698 31679261
Febrile neutropenia 14.93 13.67 25 16360 121824 31559135
Disease progression 14.74 13.67 15 16370 90449 31590510
Productive cough 14.34 13.67 44 16341 33496 31647463
Arthritis allergic 14.34 13.67 3 16382 15 31680944
Paranasal sinus mucosal hypertrophy 14.18 13.67 4 16381 79 31680880
Therapeutic drug monitoring analysis incorrectly performed 13.95 13.67 4 16381 84 31680875
Plasma cell myeloma 13.74 13.67 6 16379 56525 31624434
Sleep apnoea syndrome 13.74 13.67 30 16355 18595 31662364

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 947.08 12.21 643 34579 120150 70773072
Dyspnoea 489.27 12.21 1134 34088 768926 70124296
Chronic obstructive pulmonary disease 367.45 12.21 306 34916 77335 70815887
Wheezing 324.11 12.21 310 34912 93860 70799362
Cough 255.95 12.21 524 34698 324853 70568369
Product quality issue 251.42 12.21 168 35054 30393 70862829
Obstructive airways disorder 206.29 12.21 140 35082 25973 70867249
Emphysema 174.75 12.21 103 35119 14957 70878265
Eosinophilic granulomatosis with polyangiitis 166.56 12.21 62 35160 3151 70890071
Chest discomfort 159 12.21 248 34974 124133 70769089
Polycystic ovaries 154.69 12.21 57 35165 2815 70890407
Nasal polyps 146.10 12.21 62 35160 4454 70888768
Sleep apnoea syndrome 144.44 12.21 124 35098 32589 70860633
Sputum increased 118.91 12.21 52 35170 4020 70889202
Gastrooesophageal reflux disease 113.08 12.21 179 35043 90660 70802562
Productive cough 99.76 12.21 156 35066 78181 70815041
Sputum discoloured 98.93 12.21 79 35143 18772 70874450
Salpingo-oophorectomy unilateral 93.06 12.21 27 35195 618 70892604
Pulmonary function test decreased 90.86 12.21 51 35171 6750 70886472
Toxicity to various agents 87.82 12.21 40 35182 382132 70511090
Nasal obstruction 87.13 12.21 32 35190 1565 70891657
Rhinitis allergic 81.01 12.21 53 35169 9242 70883980
Sensitisation 80.16 12.21 34 35188 2439 70890783
Sinusitis fungal 78.84 12.21 32 35190 2053 70891169
Bronchospasm 78.21 12.21 75 35147 22717 70870505
Respiratory symptom 78.19 12.21 38 35184 3743 70889479
Bronchiectasis 77.17 12.21 64 35158 16033 70877189
Hyper IgE syndrome 77.04 12.21 22 35200 475 70892747
Ejection fraction 76.93 12.21 30 35192 1732 70891490
Asthma-chronic obstructive pulmonary disease overlap syndrome 73.17 12.21 28 35194 1536 70891686
Skin candida 73.05 12.21 29 35193 1756 70891466
Female genital tract fistula 72.75 12.21 34 35188 3069 70890153
Embolism venous 68.73 12.21 35 35187 3810 70889412
Asthmatic crisis 68.11 12.21 28 35194 1856 70891366
Blood test abnormal 67.86 12.21 57 35165 14533 70878689
Sinus pain 66.96 12.21 32 35190 3037 70890185
Eczema 64.96 12.21 82 35140 33699 70859523
Rheumatoid arthritis 63.26 12.21 33 35189 291772 70601450
Off label use 63.23 12.21 176 35046 742884 70150338
Completed suicide 60.08 12.21 19 35203 227116 70666106
Candida infection 58.99 12.21 79 35143 34394 70858828
Eosinophil count 57.29 12.21 13 35209 105 70893117
Hepatic vein dilatation 57.16 12.21 15 35207 233 70892989
Dyspnoea exertional 56.35 12.21 122 35100 78308 70814914
Restrictive pulmonary disease 56.34 12.21 26 35196 2280 70890942
Oedema peripheral 54.47 12.21 241 34981 227850 70665372
Full blood count abnormal 53.98 12.21 75 35147 33803 70859419
Chronic sinusitis 52.16 12.21 39 35183 8412 70884810
Liver palpable 52.05 12.21 15 35207 335 70892887
Joint swelling 51.46 12.21 31 35191 253180 70640042
Dysphonia 49.38 12.21 89 35133 50011 70843211
Sleep disorder due to a general medical condition 48.86 12.21 41 35181 10435 70882787
Pneumonia 47.99 12.21 479 34743 595753 70297469
Intentional product use issue 47.74 12.21 3 35219 120139 70773083
Diastolic dysfunction 46.25 12.21 38 35184 9395 70883827
Hypothyroidism 46.01 12.21 82 35140 45673 70847549
Throat irritation 44.49 12.21 70 35152 35234 70857988
Respiratory disorder 44.44 12.21 74 35148 39049 70854173
Breath sounds abnormal 44.37 12.21 43 35179 13188 70880034
Neurosensory hypoacusis 44.29 12.21 12 35210 212 70893010
Drug abuse 43.29 12.21 10 35212 147246 70745976
Ventricular enlargement 42.01 12.21 14 35208 512 70892710
Hysterectomy 41.73 12.21 29 35193 5583 70887639
Febrile neutropenia 41.52 12.21 25 35197 204293 70688929
Arthropathy 40.66 12.21 12 35210 150045 70743177
Pulmonary mass 40.53 12.21 57 35165 25976 70867246
Inferior vena cava dilatation 40.05 12.21 15 35207 775 70892447
Nephrectomy 39.95 12.21 19 35203 1784 70891438
Vocal cord dysfunction 39.72 12.21 13 35209 449 70892773
Diverticulum 39.48 12.21 41 35181 13652 70879570
Mycobacterium avium complex infection 38.62 12.21 25 35197 4281 70888941
Atrial enlargement 38.35 12.21 14 35208 673 70892549
Contraindicated product administered 37.89 12.21 10 35212 134602 70758620
Feeling jittery 37.75 12.21 37 35185 11506 70881716
Tricuspid valve incompetence 37.06 12.21 45 35177 17772 70875450
Hiatus hernia 37.02 12.21 49 35173 21085 70872137
Bronchial obstruction 36.61 12.21 20 35202 2510 70890712
Treatment failure 36.45 12.21 13 35209 144129 70749093
Pain 35.62 12.21 176 35046 628640 70264582
Product use issue 35.20 12.21 23 35199 179914 70713308
Forced expiratory volume decreased 34.89 12.21 29 35193 7285 70885937
Facial nerve disorder 34.25 12.21 13 35209 697 70892525
Osteoporosis 33.89 12.21 75 35147 48832 70844390
Rales 33.58 12.21 42 35180 17093 70876129
Musculoskeletal stiffness 33.05 12.21 16 35206 147744 70745478
Suffocation feeling 32.80 12.21 16 35206 1588 70891634
Product container issue 32.69 12.21 14 35208 1028 70892194
CFTR gene mutation 32.55 12.21 8 35214 94 70893128
Bronchopulmonary aspergillosis allergic 32.53 12.21 17 35205 1952 70891270
Dyspnoea at rest 32.45 12.21 27 35195 6792 70886430
Alopecia 31.77 12.21 31 35191 198459 70694763
Lung consolidation 31.69 12.21 29 35193 8277 70884945
Chest pain 31.40 12.21 223 34999 251037 70642185
Breast neoplasm 31.24 12.21 13 35209 889 70892333
Pericarditis 31.16 12.21 3 35219 84702 70808520
Platelet count decreased 30.71 12.21 26 35196 178196 70715026
Pulmonary congestion 30.48 12.21 49 35173 25105 70868117
White blood cell count decreased 30.34 12.21 24 35198 170117 70723105
Increased bronchial secretion 30.33 12.21 19 35203 3074 70890148
Hangover 29.98 12.21 16 35206 1917 70891305
Systemic lupus erythematosus 29.78 12.21 7 35215 101895 70791327
Swollen tongue 29.35 12.21 60 35162 36986 70856236
Drug intolerance 28.92 12.21 42 35180 225645 70667577
Lipohypertrophy 28.61 12.21 12 35210 837 70892385
Infusion related reaction 28.13 12.21 34 35188 197500 70695722
Disease progression 28.06 12.21 22 35200 156650 70736572
Urinary tract discomfort 28 12.21 10 35212 451 70892771
Peripheral vascular disorder 27.87 12.21 26 35196 7606 70885616
Bronchitis chronic 27.72 12.21 20 35202 4084 70889138
Neutropenia 27.30 12.21 54 35168 257102 70636120
Increased upper airway secretion 27.02 12.21 19 35203 3726 70889496
Eosinophilia 27.00 12.21 61 35161 40258 70852964
Nasal congestion 26.25 12.21 82 35140 65590 70827632
Stridor 26.05 12.21 21 35201 5055 70888167
Transient ischaemic attack 25.89 12.21 65 35157 45879 70847343
Diarrhoea 25.72 12.21 257 34965 783084 70110138
Alveolar osteitis 25.71 12.21 10 35212 573 70892649
Peripheral swelling 25.70 12.21 49 35173 236514 70656708
Limb injury 25.69 12.21 46 35176 25706 70867516
Angioplasty 25.41 12.21 14 35208 1786 70891436
Rhinitis 25.39 12.21 30 35192 11517 70881705
Palpitations 24.88 12.21 115 35107 110638 70782584
Hepatic enzyme increased 24.57 12.21 25 35197 156965 70736257
Peak expiratory flow rate decreased 24.47 12.21 10 35212 653 70892569
Bronchial disorder 24.45 12.21 15 35207 2339 70890883
Pulmonary embolism 24.12 12.21 146 35076 155721 70737501
Heart rate increased 23.68 12.21 110 35112 106038 70787184
Foreign body aspiration 23.63 12.21 8 35214 307 70892915
Plasma cell myeloma 23.54 12.21 4 35218 73197 70820025
Carpal tunnel syndrome 23.14 12.21 35 35187 17022 70876200
Pharyngeal oedema 22.43 12.21 33 35189 15663 70877559
Cockroach allergy 22.41 12.21 6 35216 101 70893121
Oropharyngeal pain 22.37 12.21 101 35121 96209 70797013
Fungal oesophagitis 22.13 12.21 10 35212 835 70892387
Psoriatic arthropathy 22.06 12.21 3 35219 64768 70828454
Burning sensation 22.05 12.21 67 35155 52803 70840419
Toxic neuropathy 21.76 12.21 10 35212 868 70892354
Oedema mouth 21.51 12.21 15 35207 2903 70890319
Skin lesion 21.24 12.21 54 35168 38406 70854816
Therapeutic product effect decreased 21.01 12.21 24 35198 142994 70750228
Respiratory tract haemorrhage 20.75 12.21 12 35210 1680 70891542
Dyslipidaemia 20.66 12.21 25 35197 9835 70883387
Bronchial hyperreactivity 20.54 12.21 14 35208 2612 70890610
Throat tightness 20.38 12.21 41 35181 24981 70868241
Iron deficiency anaemia 20.24 12.21 39 35183 23033 70870189
Nervous system disorder 20.19 12.21 40 35182 24106 70869116
Adrenal cortex necrosis 20.00 12.21 4 35218 16 70893206
Blood electrolytes abnormal 19.98 12.21 12 35210 1802 70891420
Bordetella test positive 19.83 12.21 3 35219 0 70893222
Crepitations 19.76 12.21 23 35199 8691 70884531
Allergic sinusitis 19.71 12.21 8 35214 513 70892709
Ear congestion 19.62 12.21 13 35209 2314 70890908
Syncope 19.49 12.21 145 35077 165564 70727658
Infection 19.30 12.21 48 35174 210737 70682485
Middle insomnia 19.30 12.21 29 35193 14024 70879198
Rebound effect 19.26 12.21 19 35203 5952 70887270
Sepsis 19.19 12.21 60 35162 244485 70648737
Arthralgia 19.15 12.21 159 35063 503231 70389991
Cardiac disorder 19.15 12.21 69 35153 59346 70833876
Animal scratch 19.04 12.21 10 35212 1160 70892062
Psoriasis 18.68 12.21 13 35209 98420 70794802
Tunnel vision 18.56 12.21 10 35212 1221 70892001
Product dose omission issue 18.52 12.21 177 35045 217291 70675931
Product use in unapproved indication 18.41 12.21 48 35174 207430 70685792
Sinusitis 18.20 12.21 145 35077 169050 70724172
Product taste abnormal 18.17 12.21 12 35210 2124 70891098
Weaning failure 17.83 12.21 8 35214 657 70892565
Urinary retention 17.79 12.21 62 35160 52458 70840764
Macrocytosis 17.76 12.21 13 35209 2714 70890508
Laryngeal cryptococcosis 17.75 12.21 3 35219 3 70893219
Orthostatic intolerance 17.69 12.21 11 35211 1756 70891466
Lower respiratory tract infection 17.41 12.21 105 35117 111808 70781414
Lung neoplasm malignant 17.20 12.21 38 35184 24704 70868518
Therapeutic product effect incomplete 17.11 12.21 110 35112 119772 70773450
Carnitine deficiency 16.99 12.21 6 35216 262 70892960
Respiratory tract congestion 16.93 12.21 31 35191 17622 70875600
Drug hypersensitivity 16.87 12.21 70 35152 262389 70630833
Essential hypertension 16.86 12.21 17 35205 5467 70887755
Kyphosis 16.84 12.21 12 35210 2404 70890818
Pyrexia 16.76 12.21 207 35015 606745 70286477
Circumstance or information capable of leading to medication error 16.64 12.21 14 35208 3576 70889646
Anosmia 16.62 12.21 16 35206 4867 70888355
Lip pruritus 16.61 12.21 8 35214 772 70892450
Encephalopathy 16.57 12.21 5 35217 61656 70831566
Panic reaction 16.47 12.21 15 35207 4256 70888966
Bladder pain 16.43 12.21 11 35211 1993 70891229
Infective exacerbation of chronic obstructive airways disease 16.42 12.21 12 35210 2499 70890723
Spontaneous haemorrhage 16.37 12.21 7 35215 512 70892710
Intentional overdose 16.18 12.21 15 35207 98420 70794802
Respiratory tract infection 16.08 12.21 52 35170 42346 70850876
Restless legs syndrome 15.98 12.21 31 35191 18397 70874825
Product prescribing error 15.90 12.21 49 35173 38903 70854319
Presbyacusis 15.89 12.21 12 35210 2625 70890597
Tubulointerstitial nephritis and uveitis syndrome 15.86 12.21 6 35216 319 70892903
Heart rate irregular 15.64 12.21 41 35181 29702 70863520
Hypomagnesaemia 15.47 12.21 50 35172 40714 70852508
Choking 15.44 12.21 23 35199 11037 70882185
Pancreatitis relapsing 15.34 12.21 8 35214 915 70892307
Anxiety 15.28 12.21 172 35050 220158 70673064
Cardiac failure chronic 15.27 12.21 22 35200 10247 70882975
COVID-19 15.26 12.21 18 35204 105739 70787483
Impaired healing 15.24 12.21 9 35213 74365 70818857
Ejection fraction abnormal 15.23 12.21 10 35212 1753 70891469
Bronchitis 15.17 12.21 105 35117 117138 70776084
Haemoptysis 15.11 12.21 58 35164 51394 70841828
Coma 15.09 12.21 14 35208 91830 70801392
Lip swelling 15.00 12.21 44 35178 34010 70859212
Nasal inflammation 14.91 12.21 7 35215 638 70892584
Anaphylactic reaction 14.78 12.21 75 35147 74899 70818323
Renal disorder 14.77 12.21 47 35175 37962 70855260
Hypertension 14.58 12.21 217 35005 295816 70597406
Status asthmaticus 14.58 12.21 8 35214 1013 70892209
Coronary artery stenosis 14.54 12.21 23 35199 11621 70881601
Restlessness 14.50 12.21 50 35172 42078 70851144
Fungal infection 14.26 12.21 46 35176 37421 70855801
Arthritis allergic 14.14 12.21 3 35219 17 70893205
Discomfort 14.11 12.21 19 35203 105417 70787805
Type 2 diabetes mellitus 14.04 12.21 51 35171 44029 70849193
Cushingoid 14.00 12.21 19 35203 8369 70884853
Paranasal sinus mucosal hypertrophy 13.98 12.21 4 35218 87 70893135
Fatigue 13.88 12.21 308 34914 824011 70069211
Neutropenic sepsis 13.85 12.21 35 35187 24795 70868427
Aortic dissection 13.84 12.21 13 35209 3834 70889388
Stomatitis 13.61 12.21 27 35195 128484 70764738
Swelling 13.59 12.21 48 35174 188491 70704731
Dust allergy 13.47 12.21 8 35214 1176 70892046
Mobility decreased 13.35 12.21 19 35203 102980 70790242
Panic attack 13.21 12.21 32 35190 22087 70871135
Depression 13.19 12.21 154 35068 198820 70694402
Gastrointestinal disorder 13.12 12.21 20 35202 105407 70787815
Bone marrow failure 13.12 12.21 4 35218 49006 70844216
Death 12.94 12.21 177 35045 509884 70383338
Mouth ulceration 12.91 12.21 42 35180 34307 70858915
Thrombocytopenia 12.87 12.21 68 35154 239042 70654180
Tracheo-oesophageal fistula 12.75 12.21 6 35216 550 70892672
Oral candidiasis 12.72 12.21 34 35188 24918 70868304
Red blood cell count decreased 12.68 12.21 5 35217 52156 70841066
Face and mouth X-ray abnormal 12.65 12.21 3 35219 30 70893192
Coronary artery disease 12.53 12.21 63 35159 62673 70830549
Complicated appendicitis 12.37 12.21 4 35218 133 70893089
Nocturnal dyspnoea 12.29 12.21 8 35214 1383 70891839
Hypotension 12.27 12.21 135 35087 404246 70488976

FDA Adverse Event Reporting System (Pediatric)

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
Congenital naevus 27.87 15.89 5 6 70 89711

Pharmacologic Action:

SourceCodeDescription
ATC R03AC13 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Selective beta-2-adrenoreceptor agonists
ATC R03AK07 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK08 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK09 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 R03AL05 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03AL07 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03AL09 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03AL10 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03AL11 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03CC15 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS FOR SYSTEMIC USE
Selective beta-2-adrenoreceptor agonists
FDA MoA N0000009922 Adrenergic beta2-Agonists
CHEBI has role CHEBI:35522 beta-adrenergic agonists
CHEBI has role CHEBI:35523 bronchodilator
CHEBI has role CHEBI:49167 anti-asthmatic drugs
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
FDA EPC N0000175779 beta2-Adrenergic Agonist

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

DiseaseRelationSNOMED_IDDOID
Pulmonary emphysema indication 87433001
Non-allergic asthma indication 266361008 DOID:9360
Severe chronic obstructive pulmonary disease indication 313299006
Allergic asthma indication 389145006 DOID:9415
Adjunct Therapy to Achieve Long-term Asthma Control indication
Exercise-Induced Bronchospasm Prevention indication
COPD Associated with Chronic Bronchitis indication
Bronchospasm Prevention with COPD indication
Mycosis contraindication 3218000 DOID:1564
Ocular hypertension contraindication 4210003 DOID:9282
Asthenia contraindication 13791008
Measles contraindication 14189004 DOID:8622
Disease caused by parasite contraindication 17322007
Glaucoma contraindication 23986001 DOID:1686
Acute tuberculosis contraindication 25629007
Immunosuppression contraindication 38013005
Hypertensive disorder contraindication 38341003 DOID:10763
Varicella contraindication 38907003 DOID:8659
Hypokalemia contraindication 43339004
Conduction disorder of the heart contraindication 44808001
Osteoporosis contraindication 64859006 DOID:11476
Diabetes mellitus contraindication 73211009 DOID:9351
Hypopituitarism contraindication 74728003 DOID:9406
Thyrotoxicosis contraindication 90739004 DOID:7997
Bilateral cataracts contraindication 95722004
Prolonged QT interval contraindication 111975006
Seizure disorder contraindication 128613002
Ophthalmic herpes simplex contraindication 186542001
Disease of liver contraindication 235856003 DOID:409
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.23 acidic
pKa2 12.47 acidic
pKa3 8.49 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.4MG/INH;0.012MG/INH DUAKLIR PRESSAIR COVIS N210595 March 29, 2019 RX POWDER, METERED INHALATION RE46417 Feb. 10, 2025 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.4MG/INH;0.012MG/INH DUAKLIR PRESSAIR COVIS N210595 March 29, 2019 RX POWDER, METERED INHALATION 10085974 March 13, 2029 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.4MG/INH;0.012MG/INH DUAKLIR PRESSAIR COVIS N210595 March 29, 2019 RX POWDER, METERED INHALATION 11000517 March 13, 2029 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 10716753 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 8324266 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 8703806 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 8808713 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 9463161 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 10716753 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 8324266 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 8703806 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 8808713 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 9463161 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 8815258 March 17, 2031 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 8815258 March 17, 2031 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.4MG/INH;0.012MG/INH DUAKLIR PRESSAIR COVIS N210595 March 29, 2019 RX POWDER, METERED INHALATION March 29, 2022 NEW COMBINATION
0.005MG/INH;0.05MG/INH DULERA ORGANON LLC N022518 Aug. 12, 2019 RX AEROSOL, METERED INHALATION Aug. 12, 2022 NEW STRENGTH
0.005MG/INH;0.05MG/INH DULERA ORGANON LLC N022518 Aug. 12, 2019 RX AEROSOL, METERED INHALATION Feb. 12, 2023 PEDIATRIC EXCLUSIVITY
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION July 23, 2023 NEW COMBINATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Beta-2 adrenergic receptor GPCR AGONIST Kd 8.60 CHEMBL CHEMBL
D(2) dopamine receptor GPCR Ki 4.89 CHEMBL
Beta-1 adrenergic receptor GPCR Ki 6.50 CHEMBL
Beta-3 adrenergic receptor GPCR EC50 7.60 CHEMBL
Heat shock protein HSP 90-alpha Cytosolic other IC50 8.52 WOMBAT-PK
D(3) dopamine receptor GPCR Ki 5.79 CHEMBL
Beta-2 adrenergic receptor GPCR EC50 8.80 CHEMBL

External reference:

IDSource
4021266 VUID
N0000148706 NUI
D01373 KEGG_DRUG
183814-30-4 SECONDARY_CAS_RN
4021266 VANDF
4021267 VANDF
4026240 VANDF
C0060657 UMLSCUI
CHEBI:5147 CHEBI
CHEMBL1256786 ChEMBL_ID
CHEMBL3989798 ChEMBL_ID
DB00983 DRUGBANK_ID
D000068759 MESH_DESCRIPTOR_UI
3083544 PUBCHEM_CID
3465 IUPHAR_LIGAND_ID
4935 INN_ID
5ZZ84GCW8B UNII
236216 RXNORM
15056 MMSL
347879 MMSL
d04572 MMSL
005421 NDDF
005422 NDDF
016698 NDDF
129490002 SNOMEDCT_US
386171009 SNOMEDCT_US
414289007 SNOMEDCT_US
447213002 SNOMEDCT_US
CHEMBL2133469 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Dulera HUMAN PRESCRIPTION DRUG LABEL 2 0085-4610 AEROSOL 5 ug RESPIRATORY (INHALATION) NDA 29 sections
Dulera HUMAN PRESCRIPTION DRUG LABEL 2 0085-7206 AEROSOL 5 ug RESPIRATORY (INHALATION) NDA 29 sections
Formoterol fumarate HUMAN PRESCRIPTION DRUG LABEL 1 0093-4061 SOLUTION 20 ug RESPIRATORY (INHALATION) ANDA 28 sections
Formoterol fumarate HUMAN PRESCRIPTION DRUG LABEL 1 0093-4061 SOLUTION 20 ug RESPIRATORY (INHALATION) ANDA 28 sections
SYMBICORT HUMAN PRESCRIPTION DRUG LABEL 2 0186-0370 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA 28 sections
SYMBICORT HUMAN PRESCRIPTION DRUG LABEL 2 0186-0370 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA 28 sections
SYMBICORT HUMAN PRESCRIPTION DRUG LABEL 2 0186-0372 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA 28 sections
SYMBICORT HUMAN PRESCRIPTION DRUG LABEL 2 0186-0372 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA 28 sections
DUAKLIR PRESSAIR HUMAN PRESCRIPTION DRUG LABEL 2 0310-0900 POWDER, METERED 12 ug RESPIRATORY (INHALATION) NDA 27 sections
BEVESPI AEROSPHERE HUMAN PRESCRIPTION DRUG LABEL 2 0310-4600 AEROSOL, METERED 4.80 ug RESPIRATORY (INHALATION) NDA 29 sections
BEVESPI AEROSPHERE HUMAN PRESCRIPTION DRUG LABEL 2 0310-4600 AEROSOL, METERED 4.80 ug RESPIRATORY (INHALATION) NDA 29 sections
BREZTRI HUMAN PRESCRIPTION DRUG LABEL 3 0310-4616 AEROSOL, METERED 4.80 ug RESPIRATORY (INHALATION) NDA 28 sections
Budesonide and Formoterol Fumarate Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0310-7370 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
Budesonide and Formoterol Fumarate Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0310-7372 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
FORMOTEROL FUMARATE HUMAN PRESCRIPTION DRUG LABEL 1 0378-1631 SOLUTION 20 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
BREYNA HUMAN PRESCRIPTION DRUG LABEL 2 0378-7502 AEROSOL, METERED 4.50 ug RESPIRATORY (INHALATION) ANDA 29 sections
BREYNA HUMAN PRESCRIPTION DRUG LABEL 2 0378-7503 AEROSOL, METERED 4.50 ug RESPIRATORY (INHALATION) ANDA 29 sections
Perforomist HUMAN PRESCRIPTION DRUG LABEL 1 49502-605 SOLUTION 20 ug RESPIRATORY (INHALATION) NDA 28 sections
Dulera HUMAN PRESCRIPTION DRUG LABEL 2 50090-1916 AEROSOL 5 ug RESPIRATORY (INHALATION) NDA 29 sections
Budesonide and Formoterol Fumarate Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 53002-2666 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA authorized generic 29 sections
Budesonide and Formoterol Fumarate Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 53002-2667 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA authorized generic 29 sections
Formoterol Fumarate Human Prescription Drug Label 1 62332-655 SOLUTION 20 ug RESPIRATORY (INHALATION) ANDA 26 sections
Formoterol Fumarate Human Prescription Drug Label 1 62332-655 SOLUTION 20 ug RESPIRATORY (INHALATION) ANDA 26 sections
Formoterol fumarate HUMAN PRESCRIPTION DRUG LABEL 1 63629-8813 SOLUTION 20 ug RESPIRATORY (INHALATION) ANDA 28 sections
Formoterol fumarate HUMAN PRESCRIPTION DRUG LABEL 1 63629-8813 SOLUTION 20 ug RESPIRATORY (INHALATION) ANDA 28 sections
Formoterol fumarate HUMAN PRESCRIPTION DRUG LABEL 1 63629-8814 SOLUTION 20 ug RESPIRATORY (INHALATION) ANDA 28 sections
Formoterol fumarate HUMAN PRESCRIPTION DRUG LABEL 1 63629-8814 SOLUTION 20 ug RESPIRATORY (INHALATION) ANDA 28 sections
SYMBICORT HUMAN PRESCRIPTION DRUG LABEL 2 70518-2696 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA 28 sections
Budesonide and Formoterol Fumarate Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 70518-3107 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
Budesonide and Formoterol Fumarate Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 70518-3107 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections