formoterol 🐶 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 µM/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
Product quality issue 654.38 12.55 323 26873 30535 50547393
Asthma 619.31 12.55 455 26741 88882 50489046
Dyspnoea 445.46 12.55 933 26263 546675 50031253
Wheezing 283.81 12.55 248 26948 61799 50516129
Cough 190.81 12.55 408 26788 240856 50337072
Obstructive airways disorder 189.16 12.55 113 27083 15539 50562389
No adverse event 177.59 12.55 146 27050 33432 50544496
Chronic obstructive pulmonary disease 161.40 12.55 170 27026 53265 50524663
Chest discomfort 154.09 12.55 218 26978 92504 50485424
Product dose omission issue 135.00 12.55 302 26894 183536 50394392
Polycystic ovaries 125.33 12.55 48 27148 2436 50575492
Sleep apnoea syndrome 120.39 12.55 101 27095 23767 50554161
Nasal polyps 116.96 12.55 46 27150 2508 50575420
Emphysema 108.16 12.55 65 27131 9028 50568900
Productive cough 98.16 12.55 131 27065 52563 50525365
Sputum increased 97.51 12.55 37 27159 1830 50576098
Gastrooesophageal reflux disease 94.84 12.55 157 27039 76271 50501657
Salpingo-oophorectomy unilateral 91.13 12.55 26 27170 515 50577413
Sinusitis fungal 87.15 12.55 31 27165 1275 50576653
Candida infection 85.93 12.55 83 27113 23440 50554488
Respiratory symptom 84.96 12.55 36 27160 2378 50575550
Hyper IgE syndrome 78.27 12.55 22 27174 412 50577516
Embolism venous 76.89 12.55 34 27162 2491 50575437
Skin candida 75.52 12.55 28 27168 1298 50576630
Rhinitis allergic 74.27 12.55 47 27149 7153 50570775
Eczema 73.47 12.55 75 27121 22627 50555301
Asthmatic crisis 73.42 12.55 29 27167 1599 50576329
Eosinophilic granulomatosis with polyangiitis 71.62 12.55 30 27166 1925 50576003
Sensitisation 67.23 12.55 27 27169 1555 50576373
Female genital tract fistula 64.83 12.55 34 27162 3632 50574296
Off label use 64.68 12.55 97 27099 474329 50103599
Ejection fraction 63.46 12.55 24 27172 1176 50576752
Dysphonia 60.93 12.55 89 27107 38803 50539125
Systemic lupus erythematosus 59.91 12.55 4 27192 140618 50437310
Mycobacterium avium complex infection 58.07 12.55 28 27168 2502 50575426
Blood test abnormal 57.27 12.55 48 27148 11271 50566657
Bronchospasm 57.25 12.55 54 27142 14800 50563128
Restrictive pulmonary disease 56.04 12.55 23 27173 1401 50576527
Chronic sinusitis 55.73 12.55 37 27159 6108 50571820
Joint swelling 53.30 12.55 33 27163 245253 50332675
Diastolic dysfunction 53.16 12.55 34 27162 5268 50572660
Treatment failure 52.98 12.55 6 27190 137631 50440297
Pneumonia 51.75 12.55 364 26832 378037 50199891
Toxicity to various agents 51.37 12.55 25 27171 212474 50365454
Sputum discoloured 48.41 12.55 47 27149 13348 50564580
Oedema peripheral 48.17 12.55 190 27006 157771 50420157
Product container issue 45.93 12.55 20 27176 1412 50576516
Diverticulum 45.60 12.55 41 27155 10573 50567355
Alopecia 45.39 12.55 39 27157 245008 50332920
Hepatic enzyme increased 43.91 12.55 10 27186 137370 50440558
Pulmonary mass 43.54 12.55 52 27144 18653 50559275
Neurosensory hypoacusis 43.19 12.55 12 27184 215 50577713
Arthropathy 42.25 12.55 16 27180 157890 50420038
Pain 41.86 12.55 165 27031 578738 49999190
Dyspnoea exertional 41.85 12.55 88 27108 51145 50526783
Drug intolerance 41.64 12.55 34 27162 219070 50358858
Hiatus hernia 41.07 12.55 50 27146 18294 50559634
Pulmonary function test decreased 39.72 12.55 24 27172 3364 50574564
White blood cell count decreased 38.31 12.55 8 27188 116714 50461214
Peripheral swelling 37.85 12.55 33 27163 205903 50372025
Facial nerve disorder 36.58 12.55 13 27183 533 50577395
Feeling jittery 36.34 12.55 37 27159 11123 50566805
Tricuspid valve incompetence 35.64 12.55 39 27157 12731 50565197
Rheumatoid arthritis 35.39 12.55 34 27162 202516 50375412
Bronchiectasis 35.15 12.55 35 27161 10248 50567680
Hysterectomy 34.92 12.55 31 27165 7859 50570069
Hypothyroidism 34.37 12.55 64 27132 34061 50543867
Product use issue 34.01 12.55 19 27177 149456 50428472
Arthralgia 33.63 12.55 122 27074 438580 50139348
Rhinitis 33.57 12.55 31 27165 8270 50569658
Product taste abnormal 33.20 12.55 17 27179 1728 50576200
CFTR gene mutation 32.49 12.55 8 27188 87 50577841
Abdominal discomfort 31.82 12.55 47 27149 231594 50346334
Lipohypertrophy 31.48 12.55 12 27184 601 50577327
Infusion related reaction 31.36 12.55 27 27169 169530 50408398
Pulmonary embolism 29.90 12.55 121 27075 101583 50476345
Underdose 29.73 12.55 45 27151 20233 50557695
Iron deficiency anaemia 28.52 12.55 40 27156 16794 50561134
Peak expiratory flow rate decreased 28.37 12.55 11 27185 577 50577351
Fatigue 28.35 12.55 244 26952 707357 49870571
Swelling 28.33 12.55 40 27156 200832 50377096
Transient ischaemic attack 28.27 12.55 57 27139 32153 50545775
Swollen tongue 27.96 12.55 53 27143 28577 50549351
Heart rate increased 27.75 12.55 98 27098 77152 50500776
Osteoporosis 27.68 12.55 69 27127 44810 50533118
Dyslipidaemia 27.45 12.55 24 27172 5964 50571964
Bronchitis chronic 27.32 12.55 20 27176 3857 50574071
Congenital naevus 27.16 12.55 8 27188 178 50577750
Drug ineffective 26.75 12.55 297 26899 819036 49758892
Increased upper airway secretion 26.28 12.55 18 27178 3126 50574802
Increased bronchial secretion 26.24 12.55 14 27182 1548 50576380
Anaphylactic reaction 26.18 12.55 76 27120 53979 50523949
Blood electrolytes abnormal 26.12 12.55 12 27184 961 50576967
Throat tightness 26.06 12.55 43 27153 20804 50557124
Febrile neutropenia 25.94 12.55 10 27186 97657 50480271
Throat irritation 25.93 12.55 53 27143 30186 50547742
Intentional product use issue 25.80 12.55 5 27191 76913 50501015
Breath sounds abnormal 25.67 12.55 26 27170 7766 50570162
Breast neoplasm 25.59 12.55 13 27183 1300 50576628
Musculoskeletal stiffness 25.58 12.55 19 27177 128462 50449466
Pulmonary congestion 25.49 12.55 36 27160 15211 50562717
Hypomagnesaemia 25.31 12.55 45 27151 23111 50554817
Lung neoplasm malignant 25.06 12.55 36 27160 15448 50562480
Drug hypersensitivity 24.80 12.55 62 27134 250948 50326980
Nephrectomy 24.64 12.55 11 27185 824 50577104
Circumstance or information capable of leading to medication error 23.73 12.55 17 27179 3171 50574757
Sleep disorder due to a general medical condition 23.20 12.55 24 27172 7347 50570581
Skin lesion 23.10 12.55 47 27149 26680 50551248
Diarrhoea 22.61 12.55 205 26991 588271 49989657
Nervous system disorder 22.38 12.55 35 27161 16188 50561740
Middle insomnia 22.14 12.55 27 27169 9894 50568034
Disease recurrence 21.91 12.55 39 27157 20042 50557886
Female reproductive neoplasm 21.91 12.55 5 27191 38 50577890
Pharyngeal oedema 21.89 12.55 31 27165 13134 50564794
Glossodynia 21.85 12.55 18 27178 115551 50462377
Incorrect dose administered 21.48 12.55 66 27130 48348 50529580
Device malfunction 21.38 12.55 33 27163 15088 50562840
Therapeutic product effect decreased 21.33 12.55 25 27171 136025 50441903
Peripheral vascular disorder 21.30 12.55 20 27176 5447 50572481
Palpitations 20.67 12.55 103 27093 94403 50483525
Impaired healing 20.53 12.55 6 27190 69780 50508148
Angioplasty 20.39 12.55 11 27185 1244 50576684
Discomfort 20.34 12.55 17 27179 108363 50469565
Neutropenic sepsis 20.18 12.55 31 27165 14116 50563812
Therapy partial responder 19.92 12.55 21 27175 6570 50571358
Drug abuse 19.84 12.55 4 27192 59842 50518086
Foreign body aspiration 19.79 12.55 6 27190 148 50577780
Macrocytosis 19.74 12.55 13 27183 2117 50575811
Coronary artery disease 19.71 12.55 47 27149 29679 50548249
Device ineffective 19.67 12.55 6 27190 151 50577777
Bordetella test positive 19.59 12.55 3 27193 0 50577928
Carnitine deficiency 19.56 12.55 6 27190 154 50577774
Respiratory tract infection 19.51 12.55 49 27147 31968 50545960
Burning sensation 19.28 12.55 61 27135 45385 50532543
Tubulointerstitial nephritis and uveitis syndrome 19.00 12.55 6 27190 170 50577758
Hypertension 18.97 12.55 185 27011 211018 50366910
Kyphosis 18.85 12.55 13 27183 2282 50575646
Infective exacerbation of chronic obstructive airways disease 18.81 12.55 10 27186 1098 50576830
Oligohydramnios 18.60 12.55 19 27177 5731 50572197
Cardiac disorder 18.52 12.55 58 27138 42921 50535007
Allergic sinusitis 18.29 12.55 8 27188 571 50577357
Spirometry abnormal 17.87 12.55 6 27190 207 50577721
Oropharyngeal pain 17.87 12.55 86 27110 77715 50500213
Fungal infection 17.36 12.55 45 27151 29920 50548008
Choking 17.16 12.55 22 27174 8476 50569452
Infection 16.85 12.55 43 27153 172911 50405017
Disease progression 16.83 12.55 16 27180 95850 50482078
Oedema mouth 16.56 12.55 12 27184 2278 50575650
Lip pruritus 16.38 12.55 8 27188 735 50577193
Restless legs syndrome 16.23 12.55 30 27166 15867 50562061
Deep vein thrombosis 16.10 12.55 80 27116 73224 50504704
Pancreatitis relapsing 16.04 12.55 8 27188 769 50577159
Mobility decreased 15.68 12.55 12 27184 79936 50497992
Limb injury 15.63 12.55 34 27162 20216 50557712
Intentional overdose 15.63 12.55 7 27189 62497 50515431
Bronchopulmonary aspergillosis allergic 15.43 12.55 9 27187 1182 50576746
Depression 15.39 12.55 146 27050 165277 50412651
Eosinophilia 15.18 12.55 32 27164 18620 50559308
Oral candidiasis 14.92 12.55 30 27166 16885 50561043
Presbyacusis 14.51 12.55 12 27184 2764 50575164
Lip swelling 14.18 12.55 37 27159 24699 50553229
Mouth ulceration 14.14 12.55 40 27156 27984 50549944
Blood immunoglobulin E increased 14.04 12.55 11 27185 2348 50575580
Nasal inflammation 13.98 12.55 6 27190 409 50577519
Left ventricular hypertrophy 13.87 12.55 15 27181 4830 50573098
Urinary retention 13.83 12.55 38 27158 26152 50551776
Long QT syndrome 13.82 12.55 12 27184 2955 50574973
Malignant neoplasm progression 13.65 12.55 10 27186 68114 50509814
Chest pain 13.54 12.55 150 27046 176732 50401196
Myocardial infarction 13.50 12.55 88 27108 88939 50488989
Neutropenia 13.49 12.55 38 27158 147927 50430001
Bronchitis 13.46 12.55 99 27097 104060 50473868
Abscess 13.42 12.55 26 27170 14246 50563682
Haemoptysis 13.40 12.55 37 27159 25536 50552392
Laryngeal oedema 13.35 12.55 15 27181 5038 50572890
Platelet count decreased 13.27 12.55 21 27175 100705 50477223
Essential hypertension 13.15 12.55 14 27182 4430 50573498
Product dosage form issue 13.12 12.55 3 27193 23 50577905
Tremor 13.06 12.55 106 27090 114797 50463131
Blister 13.06 12.55 16 27180 85402 50492526
Haemorrhage 12.94 12.55 60 27136 53381 50524547
Hypotension 12.89 12.55 74 27122 235395 50342533
Renal disorder 12.67 12.55 38 27158 27467 50550461
Carpal tunnel syndrome 12.62 12.55 28 27168 16865 50561063

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
Product quality issue 406.52 14.05 188 15377 15707 29543255
Asthma 352.13 14.05 220 15345 33629 29525333
Dyspnoea 259.01 14.05 544 15021 326188 29232774
No adverse event 167.53 14.05 108 15457 17370 29541592
Nasal obstruction 157.27 14.05 40 15525 513 29558449
Wheezing 138.67 14.05 125 15440 33115 29525847
Chronic obstructive pulmonary disease 136.50 14.05 136 15429 40819 29518143
Sinus pain 120.72 14.05 33 15532 568 29558394
Asthma-chronic obstructive pulmonary disease overlap syndrome 113.80 14.05 33 15532 710 29558252
Eosinophilic granulomatosis with polyangiitis 93.56 14.05 33 15532 1353 29557609
Pulmonary function test decreased 87.25 14.05 43 15522 4120 29554842
Emphysema 86.55 14.05 55 15510 8616 29550346
Cough 84.70 14.05 198 15367 126529 29432433
Throat irritation 80.97 14.05 53 15512 8732 29550230
Mycobacterium avium complex infection 77.76 14.05 33 15532 2236 29556726
Product dose omission issue 74.91 14.05 160 15405 96223 29462739
Bronchiectasis 73.89 14.05 45 15520 6540 29552422
Chest discomfort 63.44 14.05 98 15467 45885 29513077
Hepatic vein dilatation 62.14 14.05 16 15549 216 29558746
Sputum discoloured 61.47 14.05 40 15525 6523 29552439
Eosinophil count 60.25 14.05 14 15551 119 29558843
Vocal cord dysfunction 57.51 14.05 14 15551 148 29558814
Osteopenia 55.99 14.05 32 15533 4136 29554826
Liver palpable 53.98 14.05 15 15550 275 29558687
Lung consolidation 52.86 14.05 33 15532 5010 29553952
Respiratory disorder 52.13 14.05 54 15511 16929 29542033
Obstructive airways disorder 49.00 14.05 43 15522 10973 29547989
Suffocation feeling 48.73 14.05 16 15549 526 29558436
Atrial enlargement 47.30 14.05 14 15551 324 29558638
Ventricular enlargement 42.93 14.05 14 15551 450 29558512
Toxicity to various agents 42.72 14.05 19 15546 173642 29385320
Pulmonary mass 41.99 14.05 39 15526 10709 29548253
Inferior vena cava dilatation 41.46 14.05 15 15550 662 29558300
Dyspnoea at rest 41.37 14.05 24 15541 3190 29555772
Nasal congestion 40.78 14.05 50 15515 18829 29540133
Hangover 39.53 14.05 16 15549 961 29558001
Panic reaction 38.12 14.05 17 15548 1298 29557664
Sputum increased 37.70 14.05 19 15546 1908 29557054
Chest pain 34.37 14.05 133 15432 111840 29447122
Sleep disorder due to a general medical condition 31.50 14.05 20 15545 3126 29555836
Bronchial obstruction 31.04 14.05 15 15550 1376 29557586
Bronchial hyperreactivity 30.88 14.05 15 15550 1391 29557571
Bronchospasm 30.29 14.05 31 15534 9578 29549384
Toxic neuropathy 28.23 14.05 10 15555 415 29558547
Stridor 26.76 14.05 16 15549 2247 29556715
Fungal oesophagitis 26.76 14.05 9 15556 319 29558643
Full blood count abnormal 26.52 14.05 36 15529 14977 29543985
Weaning failure 25.82 14.05 8 15557 217 29558745
Rales 25.08 14.05 25 15540 7485 29551477
Underdose 24.93 14.05 31 15534 11838 29547124
Product container issue 24.92 14.05 10 15555 587 29558375
Foreign body aspiration 23.99 14.05 7 15558 154 29558808
Oedema mouth 23.96 14.05 12 15553 1189 29557773
Forced expiratory volume decreased 23.57 14.05 16 15549 2797 29556165
Oedema 23.48 14.05 60 15505 40423 29518539
Heart rate irregular 22.48 14.05 31 15534 13086 29545876
Cardiac failure chronic 22.47 14.05 22 15543 6445 29552517
Pneumonia 22.43 14.05 262 15303 319910 29239052
Spontaneous haemorrhage 22.35 14.05 7 15558 197 29558765
Nasal polyps 22.21 14.05 13 15552 1756 29557206
Platelet count decreased 21.97 14.05 14 15551 104658 29454304
Cockroach allergy 21.90 14.05 5 15560 39 29558923
Palpitations 21.75 14.05 51 15514 32553 29526409
Breath sounds abnormal 21.70 14.05 20 15545 5437 29553525
Bronchial disorder 21.41 14.05 11 15554 1150 29557812
Drug abuse 20.81 14.05 8 15557 79875 29479087
Adrenal cortex necrosis 20.66 14.05 4 15561 12 29558950
Orthostatic intolerance 20.62 14.05 9 15556 653 29558309
Neutropenia 19.93 14.05 24 15541 131687 29427275
Product taste abnormal 19.54 14.05 10 15555 1037 29557925
Necrotising ulcerative gingivostomatitis 19.25 14.05 5 15560 70 29558892
Nasal turbinate hypertrophy 18.69 14.05 5 15560 79 29558883
Dysphonia 18.61 14.05 35 15530 19161 29539801
Circumstance or information capable of leading to medication error 18.61 14.05 11 15554 1513 29557449
Rebound effect 18.09 14.05 12 15553 2019 29556943
Pulmonary congestion 17.82 14.05 27 15538 12409 29546553
Product prescribing error 17.71 14.05 33 15532 17943 29541019
Diarrhoea 17.61 14.05 103 15462 332595 29226367
Therapeutic product effect incomplete 17.58 14.05 53 15512 39252 29519710
Laryngeal cryptococcosis 17.57 14.05 3 15562 3 29558959
Complicated appendicitis 17.21 14.05 4 15561 34 29558928
Paradoxical drug reaction 17.03 14.05 13 15552 2728 29556234
Death 17.01 14.05 108 15457 341976 29216986
Nocturnal dyspnoea 16.52 14.05 7 15558 472 29558490
Aortic dissection 16.36 14.05 12 15553 2372 29556590
Aphonia 16.25 14.05 13 15552 2921 29556041
Coronary artery stenosis 15.81 14.05 21 15544 8552 29550410
Paranasal sinus mucosal hypertrophy 14.90 14.05 4 15561 64 29558898
Productive cough 14.79 14.05 43 15522 31216 29527746
Incorrect dose administered 14.31 14.05 44 15521 32940 29526022
Dyspnoea exertional 14.29 14.05 47 15518 36443 29522519
Arthritis allergic 14.28 14.05 3 15562 15 29558947
Oedema peripheral 14.06 14.05 98 15467 103459 29455503

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 572.21 12.00 434 32052 94791 64371455
Dyspnoea 447.44 12.00 1059 31427 717615 63748631
Wheezing 275.48 12.00 266 32220 80313 64385933
Product quality issue 253.14 12.00 168 32318 29631 64436615
Cough 212.61 12.00 469 32017 301679 64164567
Chronic obstructive pulmonary disease 189.05 12.00 205 32281 70843 64395403
Emphysema 161.40 12.00 96 32390 13973 64452273
Obstructive airways disorder 157.59 12.00 114 32372 23071 64443175
Eosinophilic granulomatosis with polyangiitis 157.39 12.00 58 32428 2824 64463422
Chest discomfort 143.90 12.00 230 32256 115876 64350370
Polycystic ovaries 135.00 12.00 48 32438 2107 64464139
Sleep apnoea syndrome 128.15 12.00 112 32374 29720 64436526
Nasal polyps 123.97 12.00 52 32434 3577 64462669
Sputum increased 113.93 12.00 49 32437 3586 64462660
Productive cough 94.75 12.00 148 32338 73055 64393191
Gastrooesophageal reflux disease 92.56 12.00 157 32329 82986 64383260
Pulmonary function test decreased 89.89 12.00 50 32436 6411 64459835
Nasal obstruction 87.90 12.00 31 32455 1328 64464918
Sputum discoloured 86.83 12.00 72 32414 17784 64448462
Salpingo-oophorectomy unilateral 85.82 12.00 24 32462 472 64465774
Toxicity to various agents 82.56 12.00 40 32446 363473 64102773
Asthma-chronic obstructive pulmonary disease overlap syndrome 81.79 12.00 28 32458 1097 64465149
Hyper IgE syndrome 76.82 12.00 22 32464 473 64465773
Respiratory symptom 75.93 12.00 35 32451 3018 64463228
Sinusitis fungal 73.92 12.00 29 32457 1677 64464569
Bronchospasm 71.02 12.00 70 32416 21612 64444634
Skin candida 70.47 12.00 28 32458 1675 64464571
Rhinitis allergic 69.66 12.00 46 32440 8032 64458214
Female genital tract fistula 67.76 12.00 31 32455 2627 64463619
Bronchiectasis 66.64 12.00 56 32430 14084 64452162
Sensitisation 66.57 12.00 27 32459 1704 64464542
Ejection fraction 63.35 12.00 24 32462 1262 64464984
Embolism venous 62.48 12.00 32 32454 3475 64462771
Completed suicide 60.29 12.00 19 32467 224395 64241851
Asthmatic crisis 59.44 12.00 25 32461 1731 64464515
Eczema 59.28 12.00 74 32412 29646 64436600
Eosinophil count 57.10 12.00 13 32473 105 64466141
Hepatic vein dilatation 56.95 12.00 15 32471 233 64466013
Candida infection 56.02 12.00 74 32412 31345 64434901
Blood test abnormal 54.38 12.00 48 32438 12895 64453351
Sinus pain 53.12 12.00 26 32460 2563 64463683
Chronic sinusitis 52.25 12.00 35 32451 6257 64459989
Liver palpable 51.96 12.00 15 32471 332 64465914
Oedema peripheral 49.89 12.00 224 32262 210093 64256153
Restrictive pulmonary disease 48.15 12.00 23 32463 2149 64464097
Breath sounds abnormal 46.49 12.00 42 32444 11627 64454619
Throat irritation 46.34 12.00 69 32417 32642 64433604
Pneumonia 45.72 12.00 456 32030 559120 63907126
Dyspnoea exertional 45.58 12.00 109 32377 73621 64392625
Neurosensory hypoacusis 44.12 12.00 12 32474 212 64466034
Dysphonia 43.13 12.00 81 32405 46301 64419945
Off label use 42.85 12.00 169 32317 632637 63833609
Ventricular enlargement 41.89 12.00 14 32472 509 64465737
Diastolic dysfunction 41.51 12.00 35 32451 8840 64457406
Vocal cord dysfunction 40.60 12.00 13 32473 412 64465834
Inferior vena cava dilatation 40.53 12.00 15 32471 739 64465507
Mycobacterium avium complex infection 40.33 12.00 25 32461 3915 64462331
Feeling jittery 39.88 12.00 37 32449 10598 64455648
Joint swelling 38.74 12.00 31 32455 215351 64250895
Atrial enlargement 38.70 12.00 14 32472 646 64465600
Drug abuse 37.75 12.00 10 32476 132364 64333882
Pulmonary mass 37.43 12.00 53 32433 23963 64442283
Hysterectomy 36.83 12.00 26 32460 5059 64461187
Intentional product use issue 36.74 12.00 3 32483 95361 64370885
Febrile neutropenia 36.34 12.00 25 32461 187632 64278614
Osteoporosis 36.07 12.00 71 32415 42009 64424237
Respiratory disorder 36.01 12.00 65 32421 36046 64430200
Diverticulum 34.91 12.00 38 32448 13160 64453086
Facial nerve disorder 34.79 12.00 13 32473 658 64465588
Product container issue 34.02 12.00 14 32472 917 64465329
Dyspnoea at rest 33.88 12.00 27 32459 6302 64459944
Tricuspid valve incompetence 33.37 12.00 42 32444 16961 64449285
Chest pain 33.24 12.00 218 32268 235762 64230484
Hypothyroidism 33.16 12.00 67 32419 40390 64425856
Suffocation feeling 32.87 12.00 16 32470 1558 64464688
Hiatus hernia 32.52 12.00 45 32441 19912 64446334
Breast neoplasm 31.72 12.00 13 32473 843 64465403
Swollen tongue 31.20 12.00 60 32426 34894 64431352
Arthropathy 31.14 12.00 11 32475 120956 64345290
Lung consolidation 31.06 12.00 28 32458 7730 64458516
Hangover 30.02 12.00 16 32470 1885 64464361
Product use issue 29.65 12.00 20 32466 151695 64314551
Bronchial obstruction 29.33 12.00 17 32469 2357 64463889
Lipohypertrophy 29.25 12.00 12 32474 780 64465466
Platelet count decreased 29.09 12.00 25 32461 167686 64298560
CFTR gene mutation 28.89 12.00 7 32479 76 64466170
Bronchitis chronic 28.23 12.00 20 32466 3912 64462334
White blood cell count decreased 28.02 12.00 23 32463 157814 64308432
Pain 27.45 12.00 165 32321 553346 63912900
Contraindicated product administered 27.42 12.00 10 32476 107819 64358427
Stridor 26.54 12.00 21 32465 4853 64461393
Eosinophilia 26.51 12.00 59 32427 38017 64428229
Increased bronchial secretion 26.50 12.00 17 32469 2825 64463421
Pulmonary congestion 26.42 12.00 45 32441 23835 64442411
Treatment failure 26.24 12.00 13 32473 116803 64349443
Sleep disorder due to a general medical condition 25.88 12.00 26 32460 8208 64458038
Bronchial disorder 25.74 12.00 15 32471 2100 64464146
Peripheral swelling 25.72 12.00 41 32445 209112 64257134
Nasal congestion 25.54 12.00 77 32409 59581 64406665
Increased upper airway secretion 25.46 12.00 18 32468 3509 64462737
Full blood count abnormal 25.25 12.00 50 32436 29707 64436539
Peak expiratory flow rate decreased 24.85 12.00 10 32476 618 64465628
Musculoskeletal stiffness 24.40 12.00 16 32470 123190 64343056
Rales 24.31 12.00 34 32452 15195 64451051
Foreign body aspiration 24.23 12.00 8 32478 280 64465966
Neutropenia 24.15 12.00 53 32433 239571 64226675
Alopecia 23.85 12.00 29 32457 165661 64300585
Transient ischaemic attack 23.81 12.00 62 32424 44120 64422126
Palpitations 23.78 12.00 110 32376 104378 64361868
Pulmonary embolism 23.58 12.00 140 32346 146216 64320030
Disease progression 23.51 12.00 22 32464 141658 64324588
Cockroach allergy 23.36 12.00 6 32480 84 64466162
Peripheral vascular disorder 22.96 12.00 23 32463 7238 64459008
Diarrhoea 22.63 12.00 244 32242 722460 63743786
Toxic neuropathy 22.57 12.00 10 32476 786 64465460
Nephrectomy 22.54 12.00 12 32474 1410 64464836
Fungal oesophagitis 22.53 12.00 10 32476 789 64465457
Rheumatoid arthritis 22.35 12.00 30 32456 164264 64301982
Pharyngeal oedema 22.34 12.00 33 32453 15498 64450748
Rebound effect 22.20 12.00 19 32467 4898 64461348
Rhinitis 21.77 12.00 27 32459 10738 64455508
Oedema mouth 21.53 12.00 15 32471 2858 64463388
Pericarditis 21.45 12.00 3 32483 62513 64403733
Product dose omission issue 21.11 12.00 169 32317 194578 64271668
Bronchial hyperreactivity 20.92 12.00 14 32472 2498 64463748
Angioplasty 20.64 12.00 12 32474 1673 64464573
Lung neoplasm malignant 20.61 12.00 38 32448 21410 64444836
Infusion related reaction 20.44 12.00 32 32454 164435 64301811
Heart rate increased 20.36 12.00 101 32385 98574 64367672
Forced expiratory volume decreased 20.34 12.00 21 32465 6846 64459400
Adrenal cortex necrosis 20.15 12.00 4 32482 15 64466231
Systemic lupus erythematosus 20.07 12.00 7 32479 77605 64388641
Blood electrolytes abnormal 19.96 12.00 12 32474 1779 64464467
Bordetella test positive 19.78 12.00 3 32483 0 64466246
Throat tightness 19.75 12.00 39 32447 23121 64443125
Oropharyngeal pain 19.08 12.00 92 32394 88775 64377471
Macrocytosis 18.84 12.00 13 32473 2439 64463807
Product taste abnormal 18.72 12.00 12 32474 1991 64464255
Drug intolerance 18.59 12.00 42 32444 187950 64278296
Dyslipidaemia 18.40 12.00 23 32463 9219 64457027
Carnitine deficiency 18.36 12.00 6 32480 203 64466043
Syncope 18.30 12.00 139 32347 157496 64308750
Weaning failure 18.19 12.00 8 32478 618 64465628
Middle insomnia 18 12.00 27 32459 12850 64453396
Anosmia 17.80 12.00 16 32470 4401 64461845
Laryngeal cryptococcosis 17.70 12.00 3 32483 3 64466243
Nervous system disorder 17.48 12.00 37 32449 23041 64443205
Spontaneous haemorrhage 17.45 12.00 7 32479 429 64465817
Skin lesion 17.45 12.00 49 32437 36433 64429813
Essential hypertension 17.44 12.00 17 32469 5177 64461069
Hepatic enzyme increased 17.40 12.00 24 32462 129919 64336327
Circumstance or information capable of leading to medication error 17.35 12.00 14 32472 3326 64462920
Cardiac failure chronic 17.21 12.00 22 32464 9019 64457227
Panic reaction 17.04 12.00 15 32471 4012 64462234
Pyrexia 16.90 12.00 190 32296 558454 63907792
Lower respiratory tract infection 16.87 12.00 93 32393 94521 64371725
Allergic sinusitis 16.83 12.00 7 32479 471 64465775
Kyphosis 16.79 12.00 12 32474 2381 64463865
Hypomagnesaemia 16.71 12.00 49 32437 37327 64428919
Tubulointerstitial nephritis and uveitis syndrome 16.56 12.00 6 32480 278 64465968
Sepsis 16.50 12.00 60 32426 230281 64235965
Iron deficiency anaemia 16.47 12.00 35 32451 21854 64444392
Lip swelling 16.40 12.00 44 32442 31863 64434383
Crepitations 16.25 12.00 20 32466 7895 64458351
Infection 16.17 12.00 44 32442 184836 64281410
Urinary retention 16.12 12.00 58 32428 49143 64417103
Complicated appendicitis 16.07 12.00 4 32482 49 64466197
Presbyacusis 16.00 12.00 12 32474 2563 64463683
Limb injury 15.89 12.00 36 32450 23469 64442777
Bronchopulmonary aspergillosis allergic 15.87 12.00 10 32476 1612 64464634
Encephalopathy 15.74 12.00 5 32481 58814 64407432
Sinusitis 15.46 12.00 126 32360 145802 64320444
Anaphylactic reaction 15.40 12.00 72 32414 68592 64397654
Heart rate irregular 15.31 12.00 39 32447 27374 64438872
Cushingoid 15.27 12.00 19 32467 7584 64458662
Nasal inflammation 15.26 12.00 7 32479 597 64465649
Cardiac disorder 15.17 12.00 62 32424 55754 64410492
Carpal tunnel syndrome 15.15 12.00 28 32458 15800 64450446
Coronary artery stenosis 14.90 12.00 23 32463 11225 64455021
Aortic dissection 14.89 12.00 13 32473 3439 64462807
Status asthmaticus 14.87 12.00 8 32478 960 64465286
Restlessness 14.87 12.00 49 32437 39736 64426510
Restless legs syndrome 14.81 12.00 29 32457 17087 64449159
Type 2 diabetes mellitus 14.64 12.00 44 32442 33976 64432270
Haemoptysis 14.55 12.00 56 32430 48992 64417254
Anxiety 14.50 12.00 161 32325 202488 64263758
Infective exacerbation of chronic obstructive airways disease 14.35 12.00 11 32475 2427 64463819
Arthralgia 14.33 12.00 148 32338 442112 64024134
Lip pruritus 14.23 12.00 7 32479 698 64465548
Arthritis allergic 14.10 12.00 3 32483 17 64466229
Coma 14.07 12.00 14 32472 87601 64378645
Oral candidiasis 14.00 12.00 34 32452 23178 64443068
Neutropenic sepsis 13.94 12.00 34 32452 23238 64443008
Paranasal sinus mucosal hypertrophy 13.92 12.00 4 32482 87 64466159
Drug hypersensitivity 13.90 12.00 67 32419 237748 64228498
Intentional overdose 13.74 12.00 15 32471 89929 64376317
Fungal infection 13.53 12.00 43 32443 34208 64432038
Orthostatic intolerance 13.52 12.00 9 32477 1591 64464655
Swelling face 13.24 12.00 62 32424 59104 64407142
Acute kidney injury 13.10 12.00 154 32332 449086 64017160
Mouth ulceration 13.07 12.00 41 32445 32403 64433843
Osteopenia 13.05 12.00 26 32460 15514 64450732
Tracheo-oesophageal fistula 13.04 12.00 6 32480 515 64465731
Bone marrow failure 12.97 12.00 4 32482 47948 64418298
Therapeutic product effect decreased 12.90 12.00 24 32462 115327 64350919
Psoriatic arthropathy 12.86 12.00 3 32483 43278 64422968
Pancreatitis relapsing 12.78 12.00 7 32479 871 64465375
Hypertension 12.66 12.00 192 32294 259069 64207177
Spirometry abnormal 12.47 12.00 6 32480 570 64465676
Nocturnal dyspnoea 12.45 12.00 8 32478 1334 64464912
Device ineffective 12.40 12.00 4 32482 130 64466116
Mobility decreased 12.37 12.00 15 32471 85825 64380421
Plasma cell myeloma 12.18 12.00 4 32482 46071 64420175
Death 12.03 12.00 171 32315 482534 63983712

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 27.57 16.44 5 6 70 84597

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




🐶 Veterinary Drug Use

None

🐶 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 N022518 Aug. 12, 2019 RX AEROSOL, METERED INHALATION Aug. 12, 2022 NEW STRENGTH
0.005MG/INH;0.05MG/INH DULERA ORGANON 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
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
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 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
DUAKLIR PRESSAIR HUMAN PRESCRIPTION DRUG LABEL 2 72124-001 POWDER, METERED 12 ug RESPIRATORY (INHALATION) NDA 26 sections
Dulera HUMAN PRESCRIPTION DRUG LABEL 2 78206-125 AEROSOL 5 ug RESPIRATORY (INHALATION) NDA 28 sections
Dulera HUMAN PRESCRIPTION DRUG LABEL 2 78206-125 AEROSOL 5 ug RESPIRATORY (INHALATION) NDA 28 sections
Dulera HUMAN PRESCRIPTION DRUG LABEL 2 78206-126 AEROSOL 5 ug RESPIRATORY (INHALATION) NDA 28 sections
Dulera HUMAN PRESCRIPTION DRUG LABEL 2 78206-126 AEROSOL 5 ug RESPIRATORY (INHALATION) NDA 28 sections