formoterol ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.527 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 12.023 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.662 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 4.864 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 51.320 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 56.690 % High 1
herg hERG pIC50 4.404 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 3.214 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 6.839 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 54.590 % High 1
kinase-safety-class ACVR2A,ACVR2B,AKT2,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,GRK2,GRK3,IGF1R,ITK,JAK2,JAK3,KDR,KIT,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 51
kinase-selectivity-class AXL,BRAF,EIF2AK3,EPHB4,ERBB2,GRK2,MAP2K6,SIK2,STK33,TEK 10
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 4.285 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 3.327 High 1
mh-clint Mouse hepatocyte intrinsic clearance 59.156 High 1
mppb Mouse plasma protein binding (% unbound) 51.320 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 5.212 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 63.740 % High 1
rat-kpuu-brain Rat brain Kpuu 0.031 % High 1
rh-clint Rat hepatocyte intrinsic clearance 29.648 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 84.720 % High 1
rppb Rat plasma protein binding (% unbound) 53.510 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 891.251 uM High 1

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 733.56 13.90 706 39606 241454 90346681
Dyspnoea 611.83 13.90 1259 39053 879696 89708439
Obstructive airways disorder 594.32 13.90 270 40042 25599 90562536
Product quality issue 428.51 13.90 323 39989 79002 90509133
Cough 385.63 13.90 631 39681 368331 90219804
Wheezing 306.96 13.90 449 39863 237631 90350504
Polycystic ovaries 267.25 13.90 99 40213 5555 90582580
Gastrooesophageal reflux disease 253.39 13.90 340 39972 165997 90422138
Nasal polyps 244.85 13.90 112 40200 10768 90577367
Blood test abnormal 243.45 13.90 138 40174 20814 90567321
Sleep apnoea syndrome 233.11 13.90 156 40156 31591 90556544
Bronchopulmonary aspergillosis allergic 231.04 13.90 80 40232 3686 90584449
Bronchiectasis 219.60 13.90 132 40180 22198 90565937
Chronic obstructive pulmonary disease 218.48 13.90 213 40099 73616 90514519
Full blood count abnormal 217.62 13.90 158 40154 36439 90551696
Rhinitis allergic 204.35 13.90 114 40198 16671 90571464
Sensitisation 193.27 13.90 72 40240 4103 90584032
Ejection fraction 177.15 13.90 62 40250 2949 90585186
Chest discomfort 175.23 13.90 259 40053 138106 90450029
Sputum discoloured 166.25 13.90 107 40205 20284 90567851
Off label use 160.54 13.90 153 40159 1102099 89486036
Rales 149.02 13.90 91 40221 15736 90572399
Pulmonary mass 143.87 13.90 112 40200 28660 90559475
Productive cough 143.19 13.90 174 40138 76889 90511246
Systemic lupus erythematosus 138.92 13.90 5 40307 361891 90226244
Product dose omission issue 136.78 13.90 359 39953 291328 90296807
Urinary tract discomfort 130.41 13.90 37 40275 875 90587260
Hypothyroidism 125.80 13.90 136 40176 52991 90535144
Emphysema 125.08 13.90 74 40238 12081 90576054
Joint swelling 124.36 13.90 35 40277 503265 90084870
Sputum increased 122.42 13.90 47 40265 2910 90585225
Alveolar osteitis 121.09 13.90 37 40275 1140 90586995
Sinusitis fungal 117.69 13.90 41 40271 1923 90586212
Salpingo-oophorectomy unilateral 114.99 13.90 34 40278 934 90587201
No adverse event 114.28 13.90 146 40166 67836 90520299
Burning sensation 112.59 13.90 140 40172 63312 90524823
Animal scratch 108.88 13.90 38 40274 1792 90586343
Tunnel vision 107.70 13.90 37 40275 1664 90586471
Asthmatic crisis 107.29 13.90 38 40274 1872 90586263
Ejection fraction abnormal 104.58 13.90 40 40272 2451 90585684
Alopecia 104.14 13.90 45 40267 495026 90093109
Arthropathy 103.34 13.90 19 40293 366223 90221912
Embolism venous 103.18 13.90 44 40268 3576 90584559
Respiratory symptom 102.72 13.90 46 40266 4206 90583929
Candida infection 102.08 13.90 99 40213 33958 90554177
Pericarditis 99.43 13.90 5 40307 270146 90317989
Hyper IgE syndrome 97.77 13.90 26 40286 479 90587656
Eosinophil count increased 97.73 13.90 65 40247 13016 90575119
Paranasal sinus discomfort 97.59 13.90 50 40262 6160 90581975
Infusion related reaction 97.46 13.90 32 40280 416748 90171387
Bladder pain 97.44 13.90 39 40273 2698 90585437
Treatment failure 96.78 13.90 11 40301 303917 90284218
Drug intolerance 95.21 13.90 40 40272 447551 90140584
Ear congestion 92.07 13.90 40 40272 3402 90584733
Skin candida 91.61 13.90 33 40279 1708 90586427
Total lung capacity decreased 91.50 13.90 41 40271 3754 90584381
Glossodynia 88.00 13.90 18 40294 321761 90266374
Eosinophilic bronchitis 87.06 13.90 25 40287 618 90587517
Dyspnoea exertional 85.29 13.90 131 40181 72157 90515978
Pneumonia 84.33 13.90 528 39784 637531 89950604
Nephrectomy 83.85 13.90 32 40280 1949 90586186
Eosinophilic granulomatosis with polyangiitis 83.02 13.90 34 40278 2496 90585639
Sleep disorder due to a general medical condition 79.82 13.90 99 40213 44639 90543496
Oedema peripheral 79.59 13.90 274 40038 257641 90330494
Psoriatic arthropathy 78.70 13.90 6 40306 228329 90359806
Impaired healing 78.39 13.90 7 40305 234192 90353943
Carpal tunnel syndrome 78.26 13.90 73 40239 23855 90564280
Polymyalgia rheumatica 78.00 13.90 40 40272 4937 90583198
Wound complication 76.74 13.90 39 40273 4724 90583411
Abdominal discomfort 75.52 13.90 61 40251 477267 90110868
Swelling 74.89 13.90 47 40265 419011 90169124
Eczema 72.73 13.90 103 40209 52767 90535368
Cardiac disorder 71.25 13.90 106 40206 56766 90531369
Diastolic dysfunction 71.18 13.90 43 40269 7290 90580845
Sinus pain 69.42 13.90 38 40274 5351 90582784
Wound secretion 69.34 13.90 37 40275 4953 90583182
Hypoacusis 68.92 13.90 73 40239 27777 90560358
Restrictive pulmonary disease 68.28 13.90 29 40283 2333 90585802
Hepatic enzyme increased 67.91 13.90 38 40274 360698 90227437
Renal disorder 67.89 13.90 84 40228 37775 90550360
Lung opacity 67.67 13.90 39 40273 6063 90582072
Haemoptysis 66.40 13.90 78 40234 33242 90554893
Product use issue 66.18 13.90 32 40280 329887 90258248
Oropharyngeal pain 65.75 13.90 153 40159 115034 90473101
Bronchospasm 65.46 13.90 62 40250 20647 90567488
Limb injury 64.86 13.90 75 40237 31433 90556702
Diverticulum 64.59 13.90 49 40263 12064 90576071
Mycobacterium avium complex infection 64.41 13.90 33 40279 4065 90584070
CFTR gene mutation 63.68 13.90 16 40296 233 90587902
Irritable bowel syndrome 62.41 13.90 9 40303 207439 90380696
Sputum culture positive 59.67 13.90 26 40286 2227 90585908
Hiatus hernia 58.41 13.90 64 40248 25297 90562838
Vital capacity decreased 58.17 13.90 24 40288 1795 90586340
Heart rate increased 58.02 13.90 144 40168 112758 90475377
Hypoaesthesia oral 57.69 13.90 51 40261 15549 90572586
Stomatitis 57.64 13.90 25 40287 274673 90313462
Therapeutic product effect decreased 57.08 13.90 26 40286 277545 90310590
Reversible airways obstruction 56.17 13.90 24 40288 1959 90586176
Toxicity to various agents 56.09 13.90 29 40283 287817 90300318
Respiratory tract infection 54.72 13.90 96 40216 58982 90529153
Liver injury 54.71 13.90 6 40306 170561 90417574
Rheumatoid arthritis 52.89 13.90 50 40262 362564 90225571
Dysphonia 52.68 13.90 98 40214 62986 90525149
Eosinophil count decreased 50.87 13.90 26 40286 3186 90584949
Tricuspid valve incompetence 50.81 13.90 49 40263 16682 90571453
Blood calcium increased 49.82 13.90 42 40270 12016 90576119
Gastrointestinal disorder 49.80 13.90 26 40286 256661 90331474
Rhinitis 49.45 13.90 44 40268 13528 90574607
Sinus disorder 48.69 13.90 68 40244 34379 90553756
Lung neoplasm malignant 48.66 13.90 57 40255 24216 90563919
Pleuritic pain 48.58 13.90 39 40273 10422 90577713
Aspiration 47.73 13.90 46 40266 15647 90572488
Discomfort 45.97 13.90 33 40279 274302 90313833
Arthralgia 45.64 13.90 185 40127 778337 89809798
Pain 45.48 13.90 259 40053 996082 89592053
Neurosensory hypoacusis 45.44 13.90 12 40300 215 90587920
Pulmonary function test decreased 45.29 13.90 27 40285 4467 90583668
Hysterectomy 45.11 13.90 39 40273 11545 90576590
Infection 44.99 13.90 57 40255 362037 90226098
Panic attack 44.88 13.90 57 40255 26308 90561827
Drug dependence 44.63 13.90 60 40252 29267 90558868
White blood cell count decreased 44.32 13.90 10 40302 167099 90421036
Myopathy 43.73 13.90 41 40271 13477 90574658
Upper-airway cough syndrome 43.48 13.90 43 40269 15092 90573043
Incorrect dose administered 43.02 13.90 103 40209 78827 90509308
Iron deficiency anaemia 41.62 13.90 52 40260 23610 90564525
Bronchitis 41.60 13.90 156 40156 152771 90435364
Product container issue 41.50 13.90 20 40292 2161 90585974
Myocardial infarction 41.22 13.90 122 40190 105850 90482285
Inflammation 41.19 13.90 14 40298 178578 90409557
Blood iron decreased 40.80 13.90 45 40267 17914 90570221
Asthma-chronic obstructive pulmonary disease overlap syndrome 40.65 13.90 26 40286 4873 90583262
Wound 40.51 13.90 45 40267 302935 90285200
Pulmonary embolism 40.31 13.90 139 40173 130681 90457454
Total lung capacity increased 40.06 13.90 26 40286 4995 90583140
Bronchial secretion retention 39.81 13.90 23 40289 3592 90584543
Mobility decreased 39.65 13.90 32 40280 250702 90337433
Polyp 38.73 13.90 30 40282 7614 90580521
Hypokinesia 38.58 13.90 41 40271 15656 90572479
Joint range of motion decreased 38.29 13.90 7 40305 135636 90452499
Facial nerve disorder 37.68 13.90 13 40299 592 90587543
Female genital tract fistula 37.56 13.90 43 40269 17825 90570310
Tremor 37.39 13.90 151 40161 153022 90435113
Sleep disorder 37.03 13.90 21 40291 198009 90390126
Blood urine present 37.03 13.90 42 40270 17236 90570899
Lip pruritus 37.01 13.90 16 40296 1344 90586791
Pancreatitis relapsing 36.83 13.90 16 40296 1360 90586775
Neutrophilia 36.75 13.90 26 40286 5752 90582383
Bursitis 36.72 13.90 7 40305 131647 90456488
Blood cholesterol increased 36.20 13.90 24 40288 207988 90380147
Nephropathy 35.77 13.90 31 40281 9204 90578931
Increased bronchial secretion 35.77 13.90 18 40294 2135 90586000
Coronary artery disease 35.59 13.90 58 40254 33565 90554570
Neutropenic sepsis 35.39 13.90 42 40270 18088 90570047
Dyslipidaemia 35.31 13.90 32 40280 10075 90578060
Vaccination site pain 34.79 13.90 11 40301 380 90587755
Feeling cold 34.12 13.90 51 40261 27414 90560721
Fatigue 34.05 13.90 339 39973 1153684 89434451
Ill-defined disorder 34.01 13.90 20 40292 184871 90403264
Sarcoidosis 33.82 13.90 32 40280 10641 90577494
Chronic sinusitis 33.66 13.90 47 40265 23755 90564380
Calculus urinary 33.61 13.90 16 40296 1682 90586453
Peripheral swelling 32.58 13.90 86 40226 413020 90175115
Syncope 32.55 13.90 131 40181 132532 90455603
Feeling jittery 32.33 13.90 37 40275 15334 90572801
Pneumococcal infection 31.78 13.90 14 40298 1231 90586904
Lipohypertrophy 31.50 13.90 12 40300 727 90587408
Pulmonary congestion 31.48 13.90 41 40271 19392 90568743
Anaphylactic reaction 31.45 13.90 98 40214 87426 90500709
Product use in unapproved indication 31.33 13.90 64 40248 336172 90251963
Rash 31.08 13.90 217 40095 795883 89792252
Transient ischaemic attack 31.07 13.90 63 40249 43113 90545022
Febrile neutropenia 30.76 13.90 16 40296 158333 90429802
Product taste abnormal 30.73 13.90 17 40295 2443 90585692
Drug ineffective 30.71 13.90 433 39879 1383865 89204270
Movement disorder 30.63 13.90 50 40262 28969 90559166
Allergic sinusitis 30.30 13.90 16 40296 2097 90586038
Joint injury 30.14 13.90 53 40259 32611 90555524
Cardiac failure 30.02 13.90 112 40200 109384 90478751
Peripheral vascular disorder 29.92 13.90 24 40288 6407 90581728
Angioplasty 29.49 13.90 14 40298 1463 90586672
Peak expiratory flow rate decreased 29.45 13.90 11 40301 631 90587504
Diabetes mellitus 29.45 13.90 79 40233 64796 90523339
Bronchitis chronic 29.37 13.90 21 40291 4722 90583413
Confusional state 29.25 13.90 82 40230 386123 90202012
Throat tightness 28.72 13.90 49 40263 29435 90558700
Psoriasis 28.59 13.90 15 40297 147739 90440396
Congenital naevus 28.49 13.90 8 40304 182 90587953
Loss of personal independence in daily activities 28.43 13.90 128 40184 135977 90452158
Urinary retention 28.27 13.90 56 40256 37688 90550447
Nervous system disorder 28.12 13.90 41 40271 21552 90566583
Hypomagnesaemia 28.11 13.90 54 40258 35534 90552601
Condition aggravated 27.52 13.90 154 40158 595391 89992744
Disease progression 27.34 13.90 18 40294 156597 90431538
Liver disorder 27.11 13.90 10 40302 121259 90466876
Procedural pain 26.82 13.90 51 40261 33309 90554826
Diarrhoea 26.78 13.90 278 40034 938912 89649223
Blood electrolytes abnormal 26.30 13.90 12 40300 1146 90586989
Skin lesion 26.27 13.90 54 40258 37311 90550824
Increased upper airway secretion 26.01 13.90 18 40294 3843 90584292
Drug hypersensitivity 25.96 13.90 112 40200 463497 90124638
Fungal infection 25.80 13.90 58 40254 42603 90545532
Breast neoplasm 25.63 13.90 13 40299 1567 90586568
Oligohydramnios 25.55 13.90 23 40289 7178 90580957
Musculoskeletal stiffness 25.50 13.90 59 40253 296473 90291662
Pharyngeal oedema 25.40 13.90 31 40281 13740 90574395
Dysarthria 25.39 13.90 67 40245 54415 90533720
Middle insomnia 25.07 13.90 34 40278 16717 90571418
Intentional product use issue 25.03 13.90 36 40276 216856 90371279
Myalgia 24.95 13.90 148 40164 174977 90413158
Deep vein thrombosis 24.52 13.90 93 40219 91527 90496608
Dysuria 24.31 13.90 54 40258 39347 90548788
Breath sounds abnormal 24.21 13.90 32 40280 15354 90572781
Blister 24.20 13.90 48 40264 254950 90333185
Restless legs syndrome 24.10 13.90 39 40273 22431 90565704
Sputum culture 24.04 13.90 8 40304 326 90587809
Drug abuse 23.78 13.90 4 40308 82343 90505792
Skin laceration 23.70 13.90 42 40270 25993 90562142
Disease recurrence 23.68 13.90 52 40260 37601 90550534
Hypoaesthesia 23.57 13.90 67 40245 314143 90273992
Pollakiuria 23.56 13.90 48 40264 32957 90555178
Forced expiratory volume decreased 23.52 13.90 20 40292 5788 90582347
Infective exacerbation of chronic obstructive airways disease 23.45 13.90 12 40300 1474 90586661
Respiratory tract congestion 23.40 13.90 43 40269 27367 90560768
Macrocytosis 23.39 13.90 15 40297 2823 90585312
Multiple allergies 23.06 13.90 31 40281 15115 90573020
Female reproductive neoplasm 22.74 13.90 5 40307 39 90588096
Jaundice cholestatic 22.53 13.90 25 40287 10018 90578117
Balance disorder 22.33 13.90 94 40218 96986 90491149
Intentional overdose 22.25 13.90 7 40305 93827 90494308
Night sweats 22.20 13.90 15 40297 128751 90459384
Therapy non-responder 22.16 13.90 17 40295 136687 90451448
Vascular graft infection 21.81 13.90 5 40307 48 90588087
Red blood cell sedimentation rate increased 21.78 13.90 5 40307 82590 90505545
Bacterial infection 21.58 13.90 38 40274 23406 90564729
Injury 21.57 13.90 34 40278 197315 90390820
Obesity 21.49 13.90 10 40302 105497 90482638
Influenza like illness 20.89 13.90 81 40231 80530 90507605
Maternal exposure during pregnancy 20.75 13.90 86 40226 359977 90228158
Haematuria 20.57 13.90 47 40265 34890 90553245
Choking 20.45 13.90 26 40286 12007 90576128
Musculoskeletal pain 20.18 13.90 28 40284 171223 90416912
Bordetella test positive 20.16 13.90 3 40309 0 90588135
C-reactive protein increased 20.06 13.90 31 40281 181358 90406777
Circumstance or information capable of leading to medication error 19.90 13.90 17 40295 4950 90583185
Carnitine deficiency 19.85 13.90 6 40306 178 90587957
Hypomania 19.70 13.90 22 40290 8875 90579260
Drug-induced liver injury 19.28 13.90 8 40304 90310 90497825
Palpitations 19.12 13.90 115 40197 136613 90451522
Malignant neoplasm progression 19.03 13.90 12 40300 106858 90481277
Swollen tongue 18.91 13.90 54 40258 45902 90542233
Throat irritation 18.87 13.90 56 40256 48639 90539496
Transaminases increased 18.63 13.90 47 40265 37145 90550990
Eosinophilia 18.62 13.90 40 40272 28493 90559642
Sciatica 18.59 13.90 11 40301 101371 90486764
Foreign body aspiration 18.56 13.90 6 40306 223 90587912
Knee arthroplasty 18.36 13.90 7 40305 83175 90504960
Kyphosis 18.29 13.90 13 40299 2895 90585240
Oedema mouth 18.17 13.90 12 40300 2374 90585761
Depression 18.13 13.90 209 40103 300392 90287743
Arthritis 18.12 13.90 29 40283 167286 90420849
Crepitations 18.10 13.90 21 40291 8831 90579304
Device malfunction 18.02 13.90 33 40279 20944 90567191
Road traffic accident 17.94 13.90 13 40299 107613 90480522
Abscess 17.88 13.90 31 40281 18860 90569275
Device ineffective 17.72 13.90 6 40306 258 90587877
Therapeutic product effect incomplete 17.68 13.90 147 40165 193749 90394386
Pyelonephritis 17.65 13.90 33 40279 21283 90566852
Drug ineffective for unapproved indication 17.64 13.90 4 40308 66640 90521495
Tubulointerstitial nephritis and uveitis syndrome 17.54 13.90 6 40306 266 90587869
Spirometry abnormal 17.48 13.90 6 40306 269 90587866
Haemorrhage 17.40 13.90 69 40243 69300 90518835
Hypotension 17.36 13.90 80 40232 325317 90262818
Hypoxia 17.36 13.90 71 40241 72328 90515807
Pancreatic calcification 17.30 13.90 4 40308 40 90588095
Vomiting 17.23 13.90 247 40065 788046 89800089
Neutropenia 16.82 13.90 48 40264 224856 90363279
Bronchial obstruction 16.64 13.90 10 40302 1679 90586456
Epilepsy 16.42 13.90 8 40304 82198 90505937
Atrial flutter 16.35 13.90 22 40290 10736 90577399
Cardiac murmur 16.11 13.90 29 40283 18165 90569970
Lipoma 15.74 13.90 12 40300 2974 90585161
Memory impairment 15.57 13.90 41 40271 197203 90390932
Presbyacusis 15.55 13.90 12 40300 3030 90585105
Mouth ulceration 15.52 13.90 46 40266 39928 90548207
Blood immunoglobulin E increased 15.44 13.90 14 40298 4411 90583724
Dysphagia 15.42 13.90 94 40218 112184 90475951
Thrombocytopenia 15.28 13.90 45 40267 208680 90379455
Influenza 15.14 13.90 110 40202 139154 90448981
Dyspepsia 15.04 13.90 42 40270 198118 90390017
Humidity intolerance 15.00 13.90 6 40306 414 90587721
Vascular graft occlusion 14.97 13.90 5 40307 206 90587929
Foreign body sensation in eyes 14.68 13.90 12 40300 3288 90584847
Hepatic cirrhosis 14.50 13.90 5 40307 63248 90524887
Bone erosion 14.40 13.90 3 40309 53018 90535117
Gait inability 14.38 13.90 27 40285 146429 90441706
Body temperature increased 14.19 13.90 48 40264 44662 90543473
Frequent bowel movements 13.95 13.90 4 40308 56931 90531204
Face and mouth X-ray abnormal 13.93 13.90 3 40309 21 90588114

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 690.86 14.87 422 22091 61892 42536930
Product quality issue 387.45 14.87 189 22324 17693 42581129
Dyspnoea 370.00 14.87 755 21758 441866 42156956
Eosinophilic granulomatosis with polyangiitis 330.63 14.87 136 22377 8502 42590320
Wheezing 274.55 14.87 229 22284 54552 42544270
Spirometry abnormal 234.90 14.87 92 22421 5054 42593768
Obstructive airways disorder 231.90 14.87 151 22362 24608 42574214
Pulmonary vasculitis 217.38 14.87 92 22421 6174 42592648
Full blood count abnormal 208.49 14.87 152 22361 29724 42569098
Mycotic allergy 207.71 14.87 83 22430 4808 42594014
Dust allergy 207.58 14.87 85 22428 5247 42593575
Neuritis 201.49 14.87 87 22426 6133 42592689
Mite allergy 194.93 14.87 80 22433 4966 42593856
Conjunctivitis allergic 192.53 14.87 83 22430 5828 42592994
Sleep disorder due to a general medical condition 182.17 14.87 114 22399 17339 42581483
Vasculitis 179.15 14.87 115 22398 18279 42580543
Asthma-chronic obstructive pulmonary disease overlap syndrome 172.78 14.87 54 22459 1505 42597317
Total lung capacity abnormal 166.74 14.87 69 22444 4374 42594448
Respiratory symptom 161.78 14.87 90 22423 11016 42587806
Forced expiratory volume decreased 157.26 14.87 78 22435 7552 42591270
Normochromic normocytic anaemia 156.14 14.87 82 22431 8949 42589873
Therapeutic product effect incomplete 153.20 14.87 188 22325 70751 42528071
Neurological symptom 151.11 14.87 83 22430 9908 42588914
Chronic obstructive pulmonary disease 147.29 14.87 174 22339 62940 42535882
Nasal obstruction 146.70 14.87 43 22470 958 42597864
Pulmonary alveolar haemorrhage 140.24 14.87 91 22422 14725 42584097
Nodule 136.17 14.87 84 22429 12450 42586372
Antineutrophil cytoplasmic antibody positive 131.43 14.87 58 22455 4307 42594515
Haemoptysis 124.13 14.87 137 22376 46030 42552792
Cough 118.05 14.87 278 22235 177825 42420997
Sinus pain 114.87 14.87 35 22478 894 42597928
Arteriosclerosis coronary artery 110.21 14.87 86 22427 18591 42580231
Arteriosclerosis 108.69 14.87 84 22429 17905 42580917
Productive cough 106.98 14.87 134 22379 51433 42547389
Pulmonary fibrosis 104.36 14.87 97 22416 26584 42572238
No adverse event 96.68 14.87 111 22402 38910 42559912
Hypothyroidism 96.39 14.87 101 22412 31983 42566839
Lung disorder 92.25 14.87 120 22393 47803 42551019
Bronchial hyperreactivity 89.83 14.87 35 22478 1894 42596928
Capillaritis 88.35 14.87 36 22477 2192 42596630
Pulmonary function test decreased 82.23 14.87 46 22467 5686 42593136
Emphysema 79.75 14.87 59 22454 11776 42587046
Mycobacterium avium complex infection 77.74 14.87 36 22477 2991 42595831
Loss of personal independence in daily activities 73.81 14.87 110 22403 49706 42549116
Sputum discoloured 69.37 14.87 51 22462 10081 42588741
Vocal cord dysfunction 68.03 14.87 17 22496 201 42598621
Off label use 67.29 14.87 149 22364 638186 41960636
Throat irritation 66.22 14.87 55 22458 12981 42585841
Eosinophil count 64.36 14.87 16 22497 185 42598637
Hepatic vein dilatation 62.15 14.87 16 22497 215 42598607
Chest discomfort 57.79 14.87 113 22400 63503 42535319
Lung consolidation 55.89 14.87 38 22475 6639 42592183
Bronchiectasis 54.59 14.87 57 22456 17962 42580860
Pulmonary function test abnormal 53.90 14.87 27 22486 2667 42596155
Toxicity to various agents 53.72 14.87 27 22486 229109 42369713
Liver palpable 53.52 14.87 15 22498 283 42598539
Suffocation feeling 52.57 14.87 18 22495 672 42598150
Osteopenia 50.82 14.87 35 22478 6243 42592579
Respiratory disorder 48.35 14.87 59 22454 22026 42576796
Anxiety 46.48 14.87 153 22360 118407 42480415
Hangover 43.80 14.87 18 22495 1120 42597702
Myoclonic epilepsy 43.27 14.87 20 22493 1654 42597168
Hypoxia 42.93 14.87 106 22407 69680 42529142
Pulmonary mass 41.50 14.87 47 22466 16218 42582604
Eosinophil count increased 39.90 14.87 38 22475 10725 42588097
Panic reaction 39.58 14.87 19 22494 1711 42597111
Nasal congestion 39.25 14.87 62 22451 29439 42569383
Inferior vena cava dilatation 38.61 14.87 15 22498 805 42598017
Chest pain 37.89 14.87 160 22353 139370 42459452
Ventricular enlargement 37.59 14.87 14 22499 669 42598153
Nasal polyps 37.28 14.87 24 22489 3827 42594995
Respiratory tract haemorrhage 36.94 14.87 17 22496 1392 42597430
Thrombosis 36.91 14.87 99 22414 68412 42530410
Atrial enlargement 36.70 14.87 14 22499 715 42598107
Dyspnoea at rest 35.13 14.87 24 22489 4225 42594597
Breath sounds abnormal 34.40 14.87 37 22476 12056 42586766
Sputum increased 33.84 14.87 21 22492 3142 42595680
Product dose omission issue 33.71 14.87 166 22347 154199 42444623
Bronchial obstruction 33.63 14.87 17 22496 1712 42597110
Product prescribing error 33.53 14.87 54 22459 26058 42572764
Disease progression 33.53 14.87 17 22496 143639 42455183
Diarrhoea 33.45 14.87 128 22385 460721 42138101
Drug abuse 31.92 14.87 8 22505 104763 42494059
Platelet count decreased 31.45 14.87 17 22496 138564 42460258
Neutropenia 29.73 14.87 37 22476 199394 42399428
Stridor 28.42 14.87 18 22495 2790 42596032
Therapeutic drug monitoring analysis incorrectly performed 26.81 14.87 9 22504 316 42598506
Toxic neuropathy 24.92 14.87 10 22503 585 42598237
Weaning failure 24.75 14.87 8 22505 249 42598573
Sleep disorder 24.40 14.87 68 22445 48027 42550795
Bronchospasm 24.35 14.87 32 22481 12853 42585969
Pulmonary embolism 24.25 14.87 126 22387 119486 42479336
Ischaemic cardiomyopathy 24.12 14.87 23 22490 6499 42592323
Fungal oesophagitis 23.95 14.87 9 22504 441 42598381
Febrile neutropenia 23.20 14.87 39 22474 185664 42413158
Heart rate irregular 23.12 14.87 35 22478 16015 42582807
Oedema mouth 22.53 14.87 12 22501 1346 42597476
Eosinophilia 22.40 14.87 52 22461 32847 42565975
Bronchial disorder 22.20 14.87 12 22501 1386 42597436
Product use in unapproved indication 21.89 14.87 40 22473 184416 42414406
Cockroach allergy 21.88 14.87 5 22508 39 42598783
COVID-19 21.25 14.87 18 22495 115930 42482892
Pain 21.12 14.87 63 22450 244785 42354037
Pain in extremity 21.10 14.87 144 22369 150460 42448362
Product container issue 20.79 14.87 10 22503 904 42597918
Urinary hesitation 20.15 14.87 15 22498 3020 42595802
Adrenal cortex necrosis 19.96 14.87 4 22509 15 42598807
Paranasal sinus mucosal hypertrophy 19.79 14.87 5 22508 62 42598760
Bronchitis 19.44 14.87 62 22451 47139 42551683
Foreign body aspiration 19.19 14.87 7 22506 315 42598507
Oedema 18.49 14.87 65 22448 51936 42546886
Cardiac failure chronic 18.39 14.87 24 22489 9577 42589245
Necrotising ulcerative gingivostomatitis 18.22 14.87 5 22508 87 42598735
Pulmonary congestion 18.14 14.87 31 22482 15699 42583123
Sepsis 18.12 14.87 50 22463 199284 42399538
Orthostatic intolerance 18.11 14.87 9 22504 874 42597948
Rales 18.06 14.87 26 22487 11374 42587448
Product use issue 18.02 14.87 9 22504 76742 42522080
Product taste abnormal 17.92 14.87 10 22503 1229 42597593
Condition aggravated 17.72 14.87 213 22300 260541 42338281
Laryngeal cryptococcosis 17.56 14.87 3 22510 3 42598819
Neutrophil count decreased 17.20 14.87 6 22507 63409 42535413
Thrombocytopenia 17.10 14.87 48 22465 190231 42408591
Underdose 16.84 14.87 31 22482 16635 42582187
Oedema peripheral 16.67 14.87 126 22387 135950 42462872
Gastrooesophageal reflux disease 16.63 14.87 57 22456 44966 42553856
Musculoskeletal stiffness 16.48 14.87 5 22508 57760 42541062
Complicated appendicitis 16.35 14.87 4 22509 43 42598779
Pancytopenia 16.35 14.87 23 22490 117720 42481102
Pyrexia 16.16 14.87 132 22381 393910 42204912
Brain injury 16.02 14.87 20 22493 7635 42591187
Abdominal distension 15.97 14.87 9 22504 71726 42527096
Spontaneous haemorrhage 15.48 14.87 7 22506 550 42598272
Status asthmaticus 15.48 14.87 6 22507 320 42598502
Bladder discomfort 15.43 14.87 5 22508 157 42598665
Tooth injury 15.17 14.87 9 22504 1242 42597580
Nocturnal dyspnoea 14.89 14.87 7 22506 601 42598221

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 940.64 13.57 835 49969 249456 110289039
Obstructive airways disorder 707.54 13.57 369 50435 45780 110492715
Dyspnoea 692.39 13.57 1546 49258 1105326 109433169
Wheezing 428.54 13.57 556 50248 254674 110283821
Eosinophilic granulomatosis with polyangiitis 420.11 13.57 165 50639 10521 110527974
Cough 417.40 13.57 754 50050 460887 110077608
Full blood count abnormal 407.41 13.57 277 50527 55775 110482720
Respiratory symptom 277.14 13.57 136 50668 14809 110523686
Spirometry abnormal 255.86 13.57 96 50708 5401 110533094
Chronic obstructive pulmonary disease 255.68 13.57 282 50522 108876 110429619
Nasal polyps 250.40 13.57 122 50682 13078 110525417
Gastrooesophageal reflux disease 239.87 13.57 351 50453 179625 110358870
Polycystic ovaries 238.77 13.57 88 50716 4708 110533787
Productive cough 234.99 13.57 276 50528 114029 110424466
Pulmonary vasculitis 229.03 13.57 93 50711 6467 110532028
Sputum discoloured 221.97 13.57 146 50658 27799 110510696
Dust allergy 219.60 13.57 88 50716 5913 110532582
Hypothyroidism 218.59 13.57 215 50589 72684 110465811
Bronchiectasis 217.91 13.57 160 50644 36333 110502162
Sleep disorder due to a general medical condition 211.37 13.57 182 50622 51930 110486565
Sleep apnoea syndrome 209.76 13.57 163 50641 40284 110498211
Mycotic allergy 206.47 13.57 84 50720 5870 110532625
Haemoptysis 202.05 13.57 204 50600 71150 110467345
Mite allergy 201.68 13.57 82 50722 5721 110532774
Neuritis 198.56 13.57 87 50717 7312 110531183
Conjunctivitis allergic 197.43 13.57 85 50719 6846 110531649
Off label use 184.54 13.57 253 50551 1499932 109038563
Blood test abnormal 181.42 13.57 130 50674 28424 110510071
Total lung capacity abnormal 177.43 13.57 70 50734 4513 110533982
Emphysema 176.11 13.57 111 50693 19645 110518850
Bronchopulmonary aspergillosis allergic 172.30 13.57 82 50722 8344 110530151
Forced expiratory volume decreased 169.95 13.57 94 50710 13082 110525413
Rhinitis allergic 163.03 13.57 102 50702 17820 110520675
Asthma-chronic obstructive pulmonary disease overlap syndrome 155.48 13.57 70 50734 6274 110532221
Chest discomfort 155.30 13.57 283 50521 173565 110364930
Sensitisation 152.33 13.57 61 50743 4090 110534405
Normochromic normocytic anaemia 151.74 13.57 87 50717 12970 110525525
Rales 144.38 13.57 107 50697 24632 110513863
Ejection fraction 138.95 13.57 52 50752 2903 110535592
Vasculitis 138.82 13.57 122 50682 35751 110502744
Antineutrophil cytoplasmic antibody positive 137.23 13.57 60 50744 5016 110533479
Sputum increased 136.32 13.57 62 50742 5689 110532806
Pulmonary alveolar haemorrhage 133.21 13.57 94 50710 20056 110518439
Pulmonary mass 132.75 13.57 121 50683 37180 110501315
Neurological symptom 132.41 13.57 85 50719 15523 110522972
Product quality issue 130.34 13.57 169 50635 77130 110461365
Sinus pain 119.55 13.57 57 50747 5822 110532673
Therapeutic product effect incomplete 118.07 13.57 294 50510 223511 110314984
Salpingo-oophorectomy unilateral 114.56 13.57 33 50771 798 110537697
Arteriosclerosis coronary artery 112.68 13.57 93 50711 25025 110513470
Joint swelling 107.12 13.57 35 50769 442810 110095685
Eosinophil count increased 105.13 13.57 83 50721 20975 110517520
Arteriosclerosis 101.41 13.57 87 50717 24680 110513815
Urinary tract discomfort 100.65 13.57 31 50773 949 110537546
Sinusitis fungal 99.91 13.57 40 50764 2680 110535815
Pulmonary function test decreased 98.51 13.57 57 50747 8643 110529852
Alveolar osteitis 97.55 13.57 31 50773 1054 110537441
Toxicity to various agents 95.32 13.57 51 50753 480504 110057991
Capillaritis 90.04 13.57 36 50768 2403 110536092
Hyper IgE syndrome 89.24 13.57 26 50778 655 110537840
Systemic lupus erythematosus 87.51 13.57 8 50796 254330 110284165
Asthmatic crisis 87.44 13.57 34 50770 2108 110536387
Ejection fraction abnormal 87.41 13.57 39 50765 3421 110535074
Nodule 86.36 13.57 90 50714 32541 110505954
Loss of personal independence in daily activities 85.39 13.57 203 50601 149817 110388678
Embolism venous 85.10 13.57 43 50761 4980 110533515
Animal scratch 84.82 13.57 32 50772 1827 110536668
Arthropathy 84.59 13.57 15 50789 287507 110250988
Pericarditis 83.85 13.57 4 50800 219110 110319385
Oedema peripheral 83.30 13.57 335 50469 328325 110210170
Nasal obstruction 82.20 13.57 37 50767 3313 110535182
Skin candida 81.25 13.57 33 50771 2295 110536200
Tunnel vision 78.78 13.57 31 50773 1984 110536511
Treatment failure 78.29 13.57 16 50788 277218 110261277
Contraindicated product administered 77.43 13.57 11 50793 248256 110290239
Psoriatic arthropathy 77.25 13.57 3 50801 196758 110341737
Pulmonary embolism 76.00 13.57 244 50560 214230 110324265
Bladder pain 75.32 13.57 33 50771 2772 110535723
Paranasal sinus discomfort 75.28 13.57 43 50761 6362 110532133
Infusion related reaction 74.76 13.57 41 50763 381121 110157374
Bronchial hyperreactivity 74.02 13.57 35 50769 3509 110534986
Nephrectomy 73.95 13.57 32 50772 2608 110535887
Alopecia 71.87 13.57 39 50765 364714 110173781
Total lung capacity decreased 71.09 13.57 43 50761 7071 110531424
Helicobacter infection 70.64 13.57 3 50801 181874 110356621
Dyspnoea exertional 70.58 13.57 151 50653 103909 110434586
Bronchospasm 70.52 13.57 78 50726 30161 110508334
Ear congestion 69.88 13.57 34 50770 3631 110534864
Lung opacity 69.34 13.57 51 50753 11601 110526894
Pulmonary fibrosis 69.13 13.57 148 50656 101894 110436601
Eosinophilic bronchitis 66.43 13.57 20 50784 566 110537929
Hypoxia 64.96 13.57 167 50637 129348 110409147
Burning sensation 63.43 13.57 114 50690 69098 110469397
CFTR gene mutation 63.17 13.57 16 50788 233 110538262
Eosinophil count 62.21 13.57 15 50789 176 110538319
Product use issue 61.88 13.57 33 50771 311662 110226833
Candida infection 61.50 13.57 92 50712 47917 110490578
Vital capacity decreased 60.94 13.57 26 50778 2047 110536448
Cardiac disorder 60.38 13.57 118 50686 76162 110462333
Pneumonia 59.72 13.57 640 50164 876074 109662421
Carpal tunnel syndrome 59.18 13.57 62 50742 22548 110515947
Hepatic vein dilatation 58.56 13.57 15 50789 229 110538266
Restrictive pulmonary disease 58.45 13.57 29 50775 3230 110535265
Impaired healing 58.42 13.57 10 50794 196707 110341788
Breath sounds abnormal 58.33 13.57 65 50739 25339 110513156
Diastolic dysfunction 57.88 13.57 47 50757 12357 110526138
Completed suicide 57.09 13.57 20 50784 242361 110296134
Liver palpable 53.16 13.57 15 50789 336 110538159
Stomatitis 53.07 13.57 29 50775 270213 110268282
Pulmonary function test abnormal 51.98 13.57 31 50773 4969 110533526
Drug intolerance 51.21 13.57 67 50737 406445 110132050
Glossodynia 51.13 13.57 19 50785 221985 110316510
Bronchial obstruction 51.12 13.57 26 50778 3053 110535442
Drug abuse 50.57 13.57 10 50794 177401 110361094
Gastrointestinal disorder 50.44 13.57 24 50780 241928 110296567
Therapeutic product effect decreased 49.77 13.57 25 50779 244291 110294204
Polymyalgia rheumatica 49.55 13.57 33 50771 6409 110532086
Pain 49.03 13.57 249 50555 954706 109583789
Diverticulum 48.77 13.57 47 50757 15479 110523016
Wound complication 48.37 13.57 32 50772 6145 110532350
Disease progression 48.19 13.57 26 50778 244008 110294487
Oropharyngeal pain 47.98 13.57 154 50650 135122 110403373
Febrile neutropenia 47.81 13.57 45 50759 316722 110221773
Mycobacterium avium complex infection 47.37 13.57 31 50773 5846 110532649
Swelling 47.21 13.57 55 50749 350986 110187509
Hysterectomy 47.12 13.57 35 50769 8079 110530416
Reversible airways obstruction 47.09 13.57 23 50781 2476 110536019
Eczema 46.84 13.57 103 50701 72190 110466305
Limb injury 46.61 13.57 71 50733 37565 110500930
Liver injury 46.11 13.57 7 50797 150406 110388089
Chronic sinusitis 45.67 13.57 57 50747 25027 110513468
Sputum culture positive 45.42 13.57 26 50778 3863 110534632
Irritable bowel syndrome 45.27 13.57 10 50794 164205 110374290
Wound secretion 45.16 13.57 32 50772 6869 110531626
Eosinophilia 45.09 13.57 89 50715 57847 110480648
Neurosensory hypoacusis 43.58 13.57 12 50792 245 110538250
Infection 43.29 13.57 62 50742 362138 110176357
Hiatus hernia 42.88 13.57 58 50746 27548 110510947
Hepatic enzyme increased 42.37 13.57 51 50753 320841 110217654
Diarrhoea 42.06 13.57 329 50475 1139176 109399319
Abdominal discomfort 41.79 13.57 73 50731 393785 110144710
Pleuritic pain 41.78 13.57 44 50760 16096 110522399
White blood cell count decreased 41.67 13.57 27 50777 229363 110309132
Tricuspid valve incompetence 41.48 13.57 53 50751 23820 110514675
Bronchitis 41.28 13.57 162 50642 156870 110381625
Lung consolidation 41.26 13.57 36 50768 10440 110528055
Blood calcium increased 41.14 13.57 46 50758 17994 110520501
Anxiety 40.86 13.57 285 50519 344793 110193702
Intentional product use issue 40.07 13.57 33 50771 247873 110290622
Bronchial secretion retention 39.28 13.57 26 50778 4998 110533497
Joint range of motion decreased 38.92 13.57 5 50799 121827 110416668
Upper-airway cough syndrome 38.88 13.57 42 50762 15815 110522680
Total lung capacity increased 38.87 13.57 26 50778 5086 110533409
Ventricular enlargement 38.69 13.57 14 50790 710 110537785
Vocal cord dysfunction 38.50 13.57 15 50789 935 110537560
Arthralgia 38.45 13.57 206 50598 779426 109759069
Inferior vena cava dilatation 38.24 13.57 15 50789 952 110537543
Hypoaesthesia oral 38.17 13.57 43 50761 16959 110521536
Bursitis 37.71 13.57 7 50797 129911 110408584
Syncope 37.37 13.57 188 50616 202348 110336147
Product use in unapproved indication 37.33 13.57 95 50709 447282 110091213
Renal disorder 37.29 13.57 75 50729 49404 110489091
Rheumatoid arthritis 37.09 13.57 50 50754 299563 110238932
Lip pruritus 36.95 13.57 16 50788 1306 110537189
Lung neoplasm malignant 36.60 13.57 60 50744 33782 110504713
Neutropenia 36.59 13.57 73 50731 374547 110163948
Respiratory tract haemorrhage 36.35 13.57 18 50786 1996 110536499
Inflammation 36.13 13.57 22 50782 193216 110345279
Female genital tract fistula 35.76 13.57 41 50763 16478 110522017
Suffocation feeling 35.71 13.57 18 50786 2073 110536422
Sinus disorder 35.36 13.57 58 50746 32670 110505825
Eosinophil count decreased 35.04 13.57 26 50778 5992 110532503
Panic attack 35.00 13.57 54 50750 28886 110509609
Hypoacusis 34.87 13.57 60 50744 35131 110503364
Increased bronchial secretion 34.72 13.57 22 50782 3926 110534569
Pancreatitis relapsing 34.69 13.57 16 50788 1516 110536979
Platelet count decreased 34.45 13.57 33 50771 230410 110308085
Drug dependence 34.38 13.57 73 50731 49947 110488548
Facial nerve disorder 34.01 13.57 13 50791 769 110537726
Peripheral swelling 33.55 13.57 86 50718 403948 110134547
Ill-defined disorder 33.55 13.57 15 50789 156838 110381657
Throat irritation 33.23 13.57 75 50729 53477 110485018
Liver disorder 33.04 13.57 12 50792 142231 110396264
Heart rate increased 32.77 13.57 142 50662 143692 110394803
Hangover 32.67 13.57 18 50786 2484 110536011
Feeling jittery 32.65 13.57 37 50767 14685 110523810
Atrial enlargement 32.40 13.57 14 50790 1137 110537358
Allergic sinusitis 32.39 13.57 16 50788 1765 110536730
Pulmonary congestion 32.27 13.57 54 50750 30912 110507583
Dysphonia 32.14 13.57 92 50712 75837 110462658
Pneumococcal infection 32.07 13.57 16 50788 1803 110536692
Confusional state 31.54 13.57 110 50694 468570 110069925
Respiratory tract infection 31.51 13.57 88 50716 71529 110466966
Drug ineffective for unapproved indication 31.03 13.57 5 50799 102833 110435662
Vaccination site pain 30.98 13.57 11 50793 528 110537967
Multiple allergies 30.98 13.57 33 50771 12230 110526265
Nasal congestion 30.51 13.57 107 50697 98175 110440320
Breast neoplasm 30.21 13.57 13 50791 1045 110537450
Neutropenic sepsis 29.91 13.57 52 50752 30694 110507801
Stridor 29.82 13.57 25 50779 6870 110531625
Dyspnoea at rest 29.54 13.57 27 50777 8319 110530176
Blood iron decreased 29.28 13.57 40 50764 19174 110519321
Peripheral vascular disorder 28.91 13.57 27 50777 8549 110529946
Rhinitis 28.58 13.57 43 50761 22502 110515993
Memory impairment 28.52 13.57 29 50775 196915 110341580
Night sweats 28.36 13.57 13 50791 133970 110404525
Hypokinesia 28.20 13.57 42 50762 21784 110516711
Product container issue 28.16 13.57 14 50790 1566 110536929
Blood cholesterol increased 28.16 13.57 26 50778 184759 110353736
Angioplasty 28.02 13.57 15 50789 1956 110536539
Mobility decreased 28.00 13.57 41 50763 237381 110301114
Bronchitis chronic 28.00 13.57 21 50783 4919 110533576
Peripheral venous disease 27.99 13.57 3 50801 84114 110454381
Lipohypertrophy 27.55 13.57 12 50792 994 110537501
Psoriasis 27.50 13.57 15 50789 139978 110398517
Obesity 27.29 13.57 9 50795 113342 110425153
Sepsis 26.92 13.57 70 50734 327276 110211219
Bronchial disorder 25.75 13.57 16 50788 2760 110535735
Vomiting 25.71 13.57 281 50523 910394 109628101
Thrombocytopenia 25.45 13.57 79 50725 348806 110189689
Musculoskeletal pain 25.32 13.57 28 50776 182995 110355500
Sarcoidosis 25.20 13.57 30 50774 12549 110525946
Intentional overdose 24.88 13.57 15 50789 132486 110406009
Sciatica 24.72 13.57 6 50798 92393 110446102
Peak expiratory flow rate decreased 24.69 13.57 10 50794 690 110537805
Urinary hesitation 24.63 13.57 19 50785 4639 110533856
COVID-19 24.57 13.57 47 50757 245013 110293482
Thrombosis 24.53 13.57 107 50697 108555 110429940
Drug ineffective 24.48 13.57 523 50281 1520017 109018478
Sputum culture 24.27 13.57 8 50796 306 110538189
Pollakiuria 24.26 13.57 59 50745 44136 110494359
Therapy non-responder 24.13 13.57 22 50782 157285 110381210
Calculus urinary 23.89 13.57 16 50788 3136 110535359
Aspiration 23.87 13.57 47 50757 30486 110508009
Nephropathy 23.56 13.57 30 50774 13437 110525058
Product prescribing error 23.50 13.57 64 50740 51267 110487228
Discomfort 23.48 13.57 39 50765 214668 110323827
Pharyngeal oedema 23.24 13.57 33 50771 16395 110522100
Ischaemic cardiomyopathy 22.83 13.57 23 50781 7988 110530507
Arthritis 22.79 13.57 26 50778 167560 110370935
Urinary retention 22.62 13.57 77 50727 69606 110468889
Disease recurrence 22.27 13.57 70 50734 60714 110477781
Cockroach allergy 22.10 13.57 6 50798 116 110538379
Iron deficiency anaemia 21.62 13.57 46 50758 31513 110506982
Oedema mouth 21.61 13.57 15 50789 3115 110535380
Injury 21.50 13.57 30 50774 177235 110361260
Infective exacerbation of chronic obstructive airways disease 21.36 13.57 15 50789 3175 110535320
Therapeutic drug monitoring analysis incorrectly performed 21.16 13.57 9 50795 703 110537792
Fatigue 21.09 13.57 413 50391 1215545 109322950
Dyslipidaemia 21.02 13.57 31 50773 15934 110522561
Macrocytosis 20.87 13.57 15 50789 3292 110535203
Hypotension 20.79 13.57 148 50656 523701 110014794
Epilepsy 20.78 13.57 10 50794 100199 110438296
Respiratory disorder 20.69 13.57 76 50728 71306 110467189
Musculoskeletal stiffness 20.66 13.57 63 50741 279759 110258736
Increased upper airway secretion 20.65 13.57 18 50786 5214 110533281
Drug-induced liver injury 20.64 13.57 15 50789 120052 110418443
Crepitations 20.33 13.57 25 50779 10810 110527685
Pancytopenia 20.32 13.57 41 50763 209572 110328923
Drug hypersensitivity 20.18 13.57 124 50680 453966 110084529
Toxic neuropathy 20.16 13.57 10 50794 1113 110537382
Foreign body aspiration 20.11 13.57 8 50796 527 110537968
Fungal oesophagitis 20.01 13.57 10 50794 1131 110537364
Cytokine release syndrome 19.95 13.57 4 50800 70302 110468193
Tremor 19.93 13.57 160 50644 202072 110336423
Osteoporosis 19.81 13.57 86 50718 87066 110451429
Blood urine present 19.78 13.57 38 50766 24207 110514288
Product dose omission issue 19.56 13.57 230 50574 321552 110216943
Chest pain 19.46 13.57 261 50543 376114 110162381
Wound 19.37 13.57 50 50754 234387 110304108
Cardiac murmur 19.36 13.57 38 50766 24590 110513905
Feeling cold 19.33 13.57 46 50758 33941 110504554
Red blood cell sedimentation rate increased 19.23 13.57 6 50798 78296 110460199
Blood electrolytes abnormal 19.17 13.57 12 50792 2096 110536399
Middle insomnia 19.07 13.57 34 50770 20468 110518027
Throat tightness 18.69 13.57 45 50759 33444 110505051
Lung disorder 18.59 13.57 144 50660 179903 110358592
Paranasal sinus mucosal hypertrophy 18.50 13.57 5 50799 95 110538400
Skin lesion 18.50 13.57 59 50745 51572 110486923
Panic reaction 18.41 13.57 17 50787 5305 110533190
Hypoaesthesia 18.38 13.57 78 50726 314145 110224350
C-reactive protein increased 18.37 13.57 46 50758 217873 110320622
Restless legs syndrome 18.16 13.57 37 50767 24589 110513906
Swollen tongue 18.12 13.57 65 50739 60297 110478198
Status asthmaticus 18.06 13.57 9 50795 1012 110537483
Laryngeal cryptococcosis 17.98 13.57 3 50801 3 110538492
Bordetella test positive 17.98 13.57 3 50801 3 110538492
Respiratory tract congestion 17.80 13.57 42 50762 30815 110507680
Sedation 17.74 13.57 5 50799 69678 110468817
Transient ischaemic attack 17.61 13.57 67 50737 63915 110474580
Adrenal cortex necrosis 17.45 13.57 4 50800 37 110538458
Myalgia 17.27 13.57 167 50637 222214 110316281
Leukopenia 17.24 13.57 26 50778 148765 110389730
Lower respiratory tract infection 17.17 13.57 179 50625 242927 110295568
Polyp 17.09 13.57 22 50782 9958 110528537
Product taste abnormal 17.08 13.57 12 50792 2540 110535955
Nervous system disorder 17.04 13.57 42 50762 31679 110506816
Anaphylactic reaction 16.95 13.57 100 50704 114200 110424295
Procedural pain 16.94 13.57 45 50759 35520 110502975
Depressed level of consciousness 16.86 13.57 16 50788 112262 110426233
Cardiogenic shock 16.83 13.57 3 50801 57335 110481160
Hypomania 16.70 13.57 22 50782 10188 110528307
Weaning failure 16.68 13.57 8 50796 828 110537667
Carnitine deficiency 16.66 13.57 6 50798 300 110538195
Myopathy 16.66 13.57 36 50768 24924 110513571
Orthostatic intolerance 16.54 13.57 11 50793 2130 110536365
Maternal exposure during pregnancy 16.35 13.57 61 50743 254822 110283673
Coma 16.34 13.57 18 50786 117851 110420644
Hip arthroplasty 16.21 13.57 3 50801 55810 110482685
Taste disorder 16.08 13.57 5 50799 65382 110473113
Presbyacusis 16.01 13.57 12 50792 2807 110535688
Heart rate irregular 15.95 13.57 43 50761 34231 110504264
Myelosuppression 15.94 13.57 12 50792 94328 110444167
Rash 15.71 13.57 274 50530 820690 109717805
Cardiac failure chronic 15.63 13.57 25 50779 13786 110524709
Tubulointerstitial nephritis 15.59 13.57 3 50801 54281 110484214
Fungal infection 15.49 13.57 55 50749 50751 110487744
Encephalopathy 15.46 13.57 9 50795 81046 110457449
Palpitations 15.16 13.57 125 50679 159087 110379408
Tubulointerstitial nephritis and uveitis syndrome 15.01 13.57 6 50798 400 110538095
Bone marrow failure 15.01 13.57 4 50800 57844 110480651
Coronary artery disease 14.98 13.57 69 50735 71621 110466874
Aspartate aminotransferase increased 14.89 13.57 32 50772 159904 110378591
Kyphosis 14.71 13.57 12 50792 3175 110535320
Abdominal pain 14.55 13.57 158 50646 512831 110025664
Arthritis allergic 14.53 13.57 3 50801 16 110538479
Drug resistance 14.43 13.57 4 50800 56370 110482125
Multiple organ dysfunction syndrome 14.42 13.57 30 50774 151680 110386815
Lipoma 14.40 13.57 13 50791 3942 110534553
Coronary artery stenosis 14.35 13.57 24 50780 13734 110524761
Movement disorder 14.34 13.57 43 50761 36361 110502134
Live birth 14.31 13.57 7 50797 69477 110469018
Pregnancy 14.29 13.57 3 50801 51064 110487431
Oligohydramnios 14.29 13.57 13 50791 3981 110534514
Foreign body sensation in eyes 14.24 13.57 12 50792 3322 110535173
Knee arthroplasty 14.22 13.57 6 50798 64942 110473553
Humidity intolerance 13.81 13.57 6 50798 494 110538001
Therapy interrupted 13.80 13.57 3 50801 49819 110488676
Aortic dissection 13.76 13.57 14 50790 4919 110533576
Nausea 13.75 13.57 448 50356 1235242 109303253
Joint injury 13.69 13.57 45 50759 39949 110498546
Incorrect dose administered 13.68 13.57 88 50716 103553 110434942
Osteopenia 13.66 13.57 31 50773 22178 110516317
Post-traumatic stress disorder 13.66 13.57 16 50788 6580 110531915

FDA Adverse Event Reporting System (Pediatric)

None

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
MeSH PA D000318 Adrenergic beta-Agonists
MeSH PA D001993 Bronchodilator Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018663 Adrenergic Agents
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D019141 Respiratory System Agents
MeSH PA D058666 Adrenergic beta-2 Receptor Agonists
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35522 ฮฒ-adrenergic agonist
CHEBI has role CHEBI:35523 bronchodilator agent
CHEBI has role CHEBI:49167 anti-asthmatic drug
CHEBI has role CHEBI:65023 anti-asthmatic agent
FDA EPC N0000175779 beta2-Adrenergic Agonist
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:53784 antispasmodic drug

Related Drugs by ATC class:

R03AC Selective beta-2-adrenoreceptor agonists 17 drugs
bitolterolcarbuterolclenbuterolfenoterolhexoprenalineindacaterolisoetarineolodaterolpirbuterolprocaterolreproterolrimiterol show all 17 →
R03AK Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics 13 drugs
beclometasone dipropionatebudesonidecromoglicic acidepinephrinefluticasone furoatefluticasone propionateindacaterolisoprenalinemometasone furoatereproterolsalbutamolsalmeterol show all 13 →
R03AL Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids 14 drugs
aclidinium bromidebeclometasone dipropionatebudesonidefenoterolfluticasone furoateglycopyrronium bromideindacaterolipratropiummometasone furoateolodaterolsalbutamoltiotropium bromide show all 14 →
R03CC Selective beta-2-adrenoreceptor agonists 14 drugs
ambroxolbambuterolcarbuterolclenbuterolfenoterolhexoprenalineisoetarinepirbuterolprocaterolreproterolsalbutamolterbutaline show all 14 →

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
0.4MG/INH;0.012MG/INH DUAKLIR PRESSAIR AZURITY 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 AZURITY 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)
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 10716753 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 8324266 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 8703806 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 8808713 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 9463161 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.08MG/INH;0.0048MG/INH SYMBICORT AEROSPHERE ASTRAZENECA N216579 April 27, 2026 RX AEROSOL, METERED INHALATION 10716753 May 28, 2030 TREATMENT OF ASTHMA IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER
0.08MG/INH;0.0048MG/INH SYMBICORT AEROSPHERE ASTRAZENECA N216579 April 27, 2026 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 TREATMENT OF ASTHMA IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER
0.16MG/INH;0.0048MG/INH SYMBICORT AEROSPHERE ASTRAZENECA N216579 April 28, 2023 RX AEROSOL, METERED INHALATION 10716753 May 28, 2030 MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH SYMBICORT AEROSPHERE ASTRAZENECA N216579 April 28, 2023 RX AEROSOL, METERED INHALATION 10716753 May 28, 2030 TREATMENT OF ASTHMA IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER
0.16MG/INH;0.0048MG/INH SYMBICORT AEROSPHERE ASTRAZENECA N216579 April 28, 2023 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH SYMBICORT AEROSPHERE ASTRAZENECA N216579 April 28, 2023 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 TREATMENT OF ASTHMA IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER
0.086MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 10159645 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.086MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 11590074 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.086MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 12357568 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.172MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 10159645 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.172MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 11590074 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.172MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 12357568 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
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)
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 8815258 March 17, 2031 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.086MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 10617638 Dec. 23, 2034 MAINTENANCE TREATMENT OF ASTHMA
0.172MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 10617638 Dec. 23, 2034 MAINTENANCE TREATMENT OF ASTHMA

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION April 27, 2029 NEW STRENGTH
0.08MG/INH;0.0048MG/INH SYMBICORT AEROSPHERE ASTRAZENECA N216579 April 27, 2026 RX AEROSOL, METERED INHALATION April 27, 2029 NEW STRENGTH
0.16MG/INH;0.0048MG/INH SYMBICORT AEROSPHERE ASTRAZENECA N216579 April 28, 2023 RX AEROSOL, METERED INHALATION April 27, 2029 TREATMENT OF ASTHMA IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER
0.086MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION May 14, 2029 NEW PRODUCT
0.172MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION May 14, 2029 NEW PRODUCT

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
CHEMBL2133469 ChEMBL_ID
D000068759 MESH_DESCRIPTOR_UI
3410 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
5ZZ84GCW8B INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 27 sections
BREZTRI HUMAN PRESCRIPTION DRUG LABEL 3 0310-4616 AEROSOL, METERED 4.80 ug RESPIRATORY (INHALATION) NDA 28 sections
BREZTRI HUMAN PRESCRIPTION DRUG LABEL 3 0310-6616 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 30 sections
BREYNA HUMAN PRESCRIPTION DRUG LABEL 2 0378-7502 AEROSOL, METERED 4.50 ug RESPIRATORY (INHALATION) ANDA 30 sections
BREYNA HUMAN PRESCRIPTION DRUG LABEL 2 0378-7503 AEROSOL, METERED 4.50 ug RESPIRATORY (INHALATION) ANDA 30 sections
BREYNA HUMAN PRESCRIPTION DRUG LABEL 2 0378-7503 AEROSOL, METERED 4.50 ug RESPIRATORY (INHALATION) ANDA 30 sections
Budesonide and formoterol fumarate dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0480-3080 AEROSOL, METERED 4.50 ug RESPIRATORY (INHALATION) ANDA 28 sections
Budesonide and formoterol fumarate dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0480-3081 AEROSOL, METERED 4.50 ug RESPIRATORY (INHALATION) ANDA 28 sections
Formoterol fumarate HUMAN PRESCRIPTION DRUG LABEL 1 0904-7454 SOLUTION 20 ug RESPIRATORY (INHALATION) ANDA 25 sections
Trimbow HUMAN PRESCRIPTION DRUG LABEL 3 10122-120 AEROSOL 6 ug ORAL NDA 31 sections
Trimbow HUMAN PRESCRIPTION DRUG LABEL 3 10122-121 AEROSOL 6 ug ORAL NDA 31 sections
Formoterol fumarate HUMAN PRESCRIPTION DRUG LABEL 1 42571-463 SOLUTION 20 ug RESPIRATORY (INHALATION) ANDA 25 sections
Formoterol Fumarate HUMAN PRESCRIPTION DRUG LABEL 1 43598-778 SOLUTION 20 ug RESPIRATORY (INHALATION) ANDA 27 sections
Perforomist HUMAN PRESCRIPTION DRUG LABEL 1 49502-605 SOLUTION 20 ug RESPIRATORY (INHALATION) NDA 28 sections
Perforomist HUMAN PRESCRIPTION DRUG LABEL 1 49502-605 SOLUTION 20 ug RESPIRATORY (INHALATION) NDA 28 sections
SYMBICORT HUMAN PRESCRIPTION DRUG LABEL 2 50090-1403 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA 29 sections
SYMBICORT HUMAN PRESCRIPTION DRUG LABEL 2 50090-4508 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA 29 sections
SYMBICORT HUMAN PRESCRIPTION DRUG LABEL 2 50090-4509 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA 29 sections
SYMBICORT HUMAN PRESCRIPTION DRUG LABEL 2 50090-4510 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA 29 sections
Budesonide and Formoterol Fumarate Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 50090-6327 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA authorized generic 29 sections
Budesonide and Formoterol Fumarate Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 50090-6382 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA authorized generic 29 sections
Formoterol Fumarate HUMAN PRESCRIPTION DRUG LABEL 1 50742-394 SOLUTION 0.02 mg RESPIRATORY (INHALATION) ANDA 28 sections
Budesonide and Formoterol Fumarate Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 53002-2666 AEROSOL 4.50 ug RESPIRATORY (INHALATION) NDA authorized generic 29 sections