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salmeterol ๐ถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| bronchodilators, phenethylamine derivatives | 2419 | 89365-50-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Salmeterol is a selective long acting beta2-adrenoceptor agonist. In vitro studies show salmeterol to be at least 50 times more selective for beta2-adrenoceptors than albuterol. Although beta2-adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-adrenoceptors are the predominant receptors in the heart, there are also beta2-adrenoceptors in the human heart comprising 10% to 50% of the total beta-adrenoceptors. The precise function of these receptors has not been established, but their presence raises the possibility that even selective beta2-agonists may have cardiac effects. The pharmacologic effects of beta2-adrenoceptor agonist drugs, including salmeterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. In vitro tests show that salmeterol is a potent and long-lasting inhibitor of the release of mast cell mediators, such as histamine, leukotrienes, and prostaglandin D2, from human lung. Salmeterol inhibits histamine-induced plasma protein extravasation and inhibits platelet-activating factor-induced eosinophil accumulation in the lungs of guinea pigs when administered by the inhaled route. In humans, single doses of salmeterol administered via inhalation aerosol attenuate allergen-induced bronchial hyper-responsiveness. It has received approval to be used in combination with fluticasone.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.10 | mg | Inhal.aerosol |
| 0.10 | mg | Inhal.powder |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 2.50 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.00 ยตM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 2.150 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 34.119 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 3.304 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 16.904 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 2.220 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 9.520 | % | High | 1 |
| herg | hERG pIC50 | 5.537 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 18.880 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 54.702 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 4.690 | % | High | 1 |
| kinase-safety-class | ACVR2A,ACVR2B,AKT1,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,IKBKB,ITK,JAK2,JAK3,KIT,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 | 55 | |||
| kinase-selectivity-class | ACVRL1,AXL,BRAF,CDK4,EIF2AK3,EPHB4,GRK2,MAP2K6,SIK2,STK33,TEK | 11 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 11.535 | High | 1 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 27.606 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 99.083 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 3.590 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 51.880 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pld-class | Phospholipidosis risk class (1 = positive, 0 = negative) | 1 | High | 1 | |
| pppb | Pig plasma protein binding (% unbound) | 9.030 | % | High | 1 |
| rat-kpuu-brain | Rat brain Kpuu | 0.047 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 179.887 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 14.230 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 5.520 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 260.016 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 26, 2021 | EMA | TEVA B.V. | |
| Feb. 4, 1994 | FDA |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | 218.49 | 12.39 | 175 | 25441 | 73654 | 90529177 |
| Asthma | 212.82 | 12.39 | 300 | 25316 | 241860 | 90360971 |
| Dyspnoea | 193.64 | 12.39 | 616 | 25000 | 880339 | 89722492 |
| Multi-organ disorder | 135.59 | 12.39 | 42 | 25574 | 2158 | 90600673 |
| Eosinophilic granulomatosis with polyangiitis | 133.90 | 12.39 | 43 | 25573 | 2487 | 90600344 |
| Chest discomfort | 123.70 | 12.39 | 173 | 25443 | 138192 | 90464639 |
| Cough | 93.59 | 12.39 | 272 | 25344 | 368690 | 90234141 |
| Eye haemorrhage | 90.01 | 12.39 | 48 | 25568 | 10132 | 90592699 |
| Cardiac failure congestive | 87.57 | 12.39 | 123 | 25493 | 98571 | 90504260 |
| Ventilation perfusion mismatch | 85.51 | 12.39 | 22 | 25594 | 570 | 90602261 |
| Synovitis | 76.77 | 12.39 | 4 | 25612 | 329748 | 90273083 |
| Product quality issue | 75.07 | 12.39 | 102 | 25514 | 79223 | 90523608 |
| Pneumonia | 69.13 | 12.39 | 359 | 25257 | 637700 | 89965131 |
| Thyroid disorder | 67.64 | 12.39 | 49 | 25567 | 17736 | 90585095 |
| Product complaint | 64.99 | 12.39 | 43 | 25573 | 13457 | 90589374 |
| Systemic lupus erythematosus | 64.73 | 12.39 | 12 | 25604 | 361884 | 90240947 |
| Bronchitis | 64.44 | 12.39 | 137 | 25479 | 152790 | 90450041 |
| Malnutrition | 61.34 | 12.39 | 47 | 25569 | 18511 | 90584320 |
| Dysphonia | 58.00 | 12.39 | 80 | 25536 | 63004 | 90539827 |
| Bronchospasm | 56.79 | 12.39 | 47 | 25569 | 20662 | 90582169 |
| Status asthmaticus | 54.72 | 12.39 | 17 | 25599 | 882 | 90601949 |
| Off label use | 53.17 | 12.39 | 149 | 25467 | 1102103 | 89500728 |
| Pericarditis | 52.73 | 12.39 | 7 | 25609 | 270144 | 90332687 |
| Psoriatic arthropathy | 52.41 | 12.39 | 3 | 25613 | 228332 | 90374499 |
| Anticoagulant therapy | 52.05 | 12.39 | 16 | 25600 | 801 | 90602030 |
| Chest pain | 51.93 | 12.39 | 203 | 25413 | 319442 | 90283389 |
| Glossodynia | 50.87 | 12.39 | 14 | 25602 | 321765 | 90281066 |
| Analgesic therapy | 50.73 | 12.39 | 15 | 25601 | 657 | 90602174 |
| Antacid therapy | 49.03 | 12.39 | 15 | 25601 | 739 | 90602092 |
| Appendicolith | 48.89 | 12.39 | 15 | 25601 | 746 | 90602085 |
| Drug therapy | 47.99 | 12.39 | 15 | 25601 | 794 | 90602037 |
| Arthropathy | 46.05 | 12.39 | 23 | 25593 | 366219 | 90236612 |
| Pulmonary oedema | 44.45 | 12.39 | 70 | 25546 | 62010 | 90540821 |
| Myocardial infarction | 43.54 | 12.39 | 94 | 25522 | 105878 | 90496953 |
| Impaired healing | 43.54 | 12.39 | 7 | 25609 | 234192 | 90368639 |
| Abdominal discomfort | 42.91 | 12.39 | 43 | 25573 | 477285 | 90125546 |
| Wheezing | 42.61 | 12.39 | 156 | 25460 | 237924 | 90364907 |
| Intentional product use issue | 41.42 | 12.39 | 6 | 25610 | 216886 | 90385945 |
| Pericardial effusion | 40.48 | 12.39 | 51 | 25565 | 36782 | 90566049 |
| Myalgia | 40.41 | 12.39 | 125 | 25491 | 175000 | 90427831 |
| Peripheral swelling | 39.73 | 12.39 | 35 | 25581 | 413071 | 90189760 |
| Product use in unapproved indication | 38.11 | 12.39 | 24 | 25592 | 336212 | 90266619 |
| Stress fracture | 38.03 | 12.39 | 26 | 25590 | 8585 | 90594246 |
| Productive cough | 37.12 | 12.39 | 73 | 25543 | 76990 | 90525841 |
| Irritable bowel syndrome | 36.81 | 12.39 | 7 | 25609 | 207441 | 90395390 |
| Laryngeal pain | 36.71 | 12.39 | 20 | 25596 | 4402 | 90598429 |
| International normalised ratio increased | 34.77 | 12.39 | 54 | 25562 | 47262 | 90555569 |
| Alopecia | 33.71 | 12.39 | 55 | 25561 | 495016 | 90107815 |
| Increased upper airway secretion | 33.55 | 12.39 | 18 | 25598 | 3843 | 90598988 |
| Discomfort | 33.32 | 12.39 | 18 | 25598 | 274317 | 90328514 |
| Wound | 31.18 | 12.39 | 24 | 25592 | 302956 | 90299875 |
| Contraindicated product administered | 30.91 | 12.39 | 27 | 25589 | 320112 | 90282719 |
| Activated partial thromboplastin time prolonged | 30.76 | 12.39 | 22 | 25594 | 7803 | 90595028 |
| Palpitations | 30.06 | 12.39 | 96 | 25520 | 136632 | 90466199 |
| Therapeutic product effect decreased | 29.84 | 12.39 | 21 | 25595 | 277550 | 90325281 |
| COVID-19 | 29.32 | 12.39 | 6 | 25610 | 168837 | 90433994 |
| Throat irritation | 28.29 | 12.39 | 50 | 25566 | 48645 | 90554186 |
| Gastrointestinal disorder | 28.15 | 12.39 | 19 | 25597 | 256668 | 90346163 |
| Blood glucose increased | 27.79 | 12.39 | 74 | 25542 | 95172 | 90507659 |
| Inflammation | 27.78 | 12.39 | 8 | 25608 | 178584 | 90424247 |
| Joint range of motion decreased | 27.72 | 12.39 | 3 | 25613 | 135640 | 90467191 |
| Completed suicide | 27.72 | 12.39 | 4 | 25612 | 145054 | 90457777 |
| Aortic stenosis | 27.67 | 12.39 | 19 | 25597 | 6317 | 90596514 |
| Haemoptysis | 27.29 | 12.39 | 40 | 25576 | 33280 | 90569551 |
| Dysmetropsia | 26.81 | 12.39 | 6 | 25610 | 84 | 90602747 |
| Blood phosphorus increased | 26.40 | 12.39 | 16 | 25600 | 4302 | 90598529 |
| Acute respiratory failure | 26.14 | 12.39 | 45 | 25571 | 42873 | 90559958 |
| Temperature regulation disorder | 26.02 | 12.39 | 26 | 25590 | 14553 | 90588278 |
| Hyperphosphataemia | 25.96 | 12.39 | 15 | 25601 | 3696 | 90599135 |
| Erysipelas | 25.77 | 12.39 | 21 | 25595 | 9031 | 90593800 |
| Sputum discoloured | 25.27 | 12.39 | 30 | 25586 | 20361 | 90582470 |
| Nasal oedema | 24.71 | 12.39 | 18 | 25598 | 6566 | 90596265 |
| Treatment failure | 24.41 | 12.39 | 30 | 25586 | 303898 | 90298933 |
| Fibromyalgia | 24.37 | 12.39 | 14 | 25602 | 206255 | 90396576 |
| Stomatitis | 24.37 | 12.39 | 25 | 25591 | 274673 | 90328158 |
| Blood calcium increased | 24.33 | 12.39 | 23 | 25593 | 12035 | 90590796 |
| Blister | 24.02 | 12.39 | 22 | 25594 | 254976 | 90347855 |
| Hypoxia | 23.97 | 12.39 | 59 | 25557 | 72340 | 90530491 |
| Tremor | 23.80 | 12.39 | 96 | 25520 | 153077 | 90449754 |
| Infusion related reaction | 23.36 | 12.39 | 52 | 25564 | 416728 | 90186103 |
| Respiratory failure | 23.22 | 12.39 | 80 | 25536 | 118338 | 90484493 |
| Musculoskeletal stiffness | 23.05 | 12.39 | 30 | 25586 | 296502 | 90306329 |
| Eczema impetiginous | 22.67 | 12.39 | 4 | 25612 | 14 | 90602817 |
| Derealisation | 22.13 | 12.39 | 10 | 25606 | 1475 | 90601356 |
| Mobility decreased | 22.03 | 12.39 | 23 | 25593 | 250711 | 90352120 |
| C-reactive protein increased | 21.87 | 12.39 | 12 | 25604 | 181377 | 90421454 |
| Diabetes mellitus | 21.61 | 12.39 | 53 | 25563 | 64822 | 90538009 |
| Appendicitis | 21.58 | 12.39 | 20 | 25596 | 10211 | 90592620 |
| Food allergy | 21.46 | 12.39 | 31 | 25585 | 25447 | 90577384 |
| Cortisol decreased | 20.51 | 12.39 | 10 | 25606 | 1749 | 90601082 |
| Emotional distress | 20.47 | 12.39 | 37 | 25579 | 36625 | 90566206 |
| Fracture displacement | 20.45 | 12.39 | 9 | 25607 | 1247 | 90601584 |
| Varicella zoster oesophagitis | 20.38 | 12.39 | 4 | 25612 | 28 | 90602803 |
| Aspergilloma | 19.86 | 12.39 | 6 | 25610 | 283 | 90602548 |
| Neuropathy peripheral | 19.82 | 12.39 | 84 | 25532 | 136886 | 90465945 |
| Candida infection | 19.82 | 12.39 | 35 | 25581 | 34022 | 90568809 |
| Middle insomnia | 19.70 | 12.39 | 24 | 25592 | 16727 | 90586104 |
| Kounis syndrome | 19.69 | 12.39 | 11 | 25605 | 2542 | 90600289 |
| Inhalation therapy | 19.20 | 12.39 | 4 | 25612 | 39 | 90602792 |
| Varicella zoster gastritis | 19.11 | 12.39 | 4 | 25612 | 40 | 90602791 |
| Granuloma | 18.99 | 12.39 | 15 | 25601 | 6170 | 90596661 |
| Type 2 diabetes mellitus | 18.59 | 12.39 | 18 | 25598 | 203226 | 90399605 |
| Calculus bladder | 18.55 | 12.39 | 7 | 25609 | 654 | 90602177 |
| Hyperhidrosis | 18.50 | 12.39 | 82 | 25534 | 136223 | 90466608 |
| Ecchymosis | 18.45 | 12.39 | 20 | 25596 | 12303 | 90590528 |
| Investigation | 18.39 | 12.39 | 9 | 25607 | 1588 | 90601243 |
| Pharyngeal oedema | 18.29 | 12.39 | 21 | 25595 | 13750 | 90589081 |
| Nasopharyngitis | 18.09 | 12.39 | 57 | 25559 | 407047 | 90195784 |
| Blood uric acid increased | 18.09 | 12.39 | 16 | 25600 | 7688 | 90595143 |
| Joint swelling | 18.08 | 12.39 | 77 | 25539 | 503223 | 90099608 |
| Throat tightness | 18.07 | 12.39 | 31 | 25585 | 29453 | 90573378 |
| Femur fracture | 17.92 | 12.39 | 40 | 25576 | 46042 | 90556789 |
| Maternal exposure during pregnancy | 17.76 | 12.39 | 48 | 25568 | 360015 | 90242816 |
| Back pain | 17.45 | 12.39 | 151 | 25465 | 317024 | 90285807 |
| Rash erythematous | 17.41 | 12.39 | 49 | 25567 | 65055 | 90537776 |
| Ill-defined disorder | 17.35 | 12.39 | 16 | 25600 | 184875 | 90417956 |
| Pulmonary embolism | 17.23 | 12.39 | 78 | 25538 | 130742 | 90472089 |
| Neutropenia | 17.22 | 12.39 | 23 | 25593 | 224881 | 90377950 |
| Foetal death | 17.14 | 12.39 | 25 | 25591 | 20698 | 90582133 |
| Headache | 17.04 | 12.39 | 340 | 25276 | 862406 | 89740425 |
| Oligohydramnios | 17.00 | 12.39 | 15 | 25601 | 7186 | 90595645 |
| Intentional overdose | 17.00 | 12.39 | 3 | 25613 | 93831 | 90509000 |
| Drug intolerance | 16.99 | 12.39 | 67 | 25549 | 447524 | 90155307 |
| Sleep disorder therapy | 16.80 | 12.39 | 6 | 25610 | 480 | 90602351 |
| Cholecystitis chronic | 16.58 | 12.39 | 17 | 25599 | 9809 | 90593022 |
| Peroneal nerve injury | 16.48 | 12.39 | 4 | 25612 | 81 | 90602750 |
| Anxiety | 16.28 | 12.39 | 146 | 25470 | 309626 | 90293205 |
| Product use issue | 16.25 | 12.39 | 44 | 25572 | 329875 | 90272956 |
| Anaphylactic reaction | 16.18 | 12.39 | 58 | 25558 | 87466 | 90515365 |
| Hypercapnia | 15.95 | 12.39 | 14 | 25602 | 6663 | 90596168 |
| Nikolsky's sign | 15.92 | 12.39 | 4 | 25612 | 94 | 90602737 |
| Oedema peripheral | 15.90 | 12.39 | 126 | 25490 | 257789 | 90345042 |
| Cerebrovascular accident | 15.78 | 12.39 | 73 | 25543 | 123460 | 90479371 |
| Emphysema | 15.25 | 12.39 | 18 | 25598 | 12137 | 90590694 |
| Hyperlipidaemia | 15.25 | 12.39 | 25 | 25591 | 22891 | 90579940 |
| Toxicity to various agents | 15.24 | 12.39 | 37 | 25579 | 287809 | 90315022 |
| Uterine hypertonus | 15.14 | 12.39 | 5 | 25611 | 316 | 90602515 |
| Upper respiratory tract infection | 15.07 | 12.39 | 74 | 25542 | 128244 | 90474587 |
| Myoclonic dystonia | 15.04 | 12.39 | 3 | 25613 | 23 | 90602808 |
| Bacterial infection | 14.83 | 12.39 | 25 | 25591 | 23419 | 90579412 |
| End stage renal disease | 14.77 | 12.39 | 15 | 25601 | 8556 | 90594275 |
| Wound infection | 14.41 | 12.39 | 6 | 25610 | 106396 | 90496435 |
| Obesity | 14.21 | 12.39 | 6 | 25610 | 105501 | 90497330 |
| Drug abuse | 14.14 | 12.39 | 3 | 25613 | 82344 | 90520487 |
| Urethral pain | 14.06 | 12.39 | 5 | 25611 | 395 | 90602436 |
| Gastroduodenal ulcer | 13.92 | 12.39 | 5 | 25611 | 407 | 90602424 |
| Blood potassium decreased | 13.83 | 12.39 | 37 | 25579 | 47690 | 90555141 |
| Choking | 13.76 | 12.39 | 17 | 25599 | 12016 | 90590815 |
| Gout | 13.46 | 12.39 | 20 | 25596 | 16839 | 90585992 |
| Arthritis | 13.36 | 12.39 | 87 | 25529 | 167228 | 90435603 |
| Live birth | 13.34 | 12.39 | 3 | 25613 | 79104 | 90523727 |
| Hypoaesthesia eye | 13.34 | 12.39 | 5 | 25611 | 459 | 90602372 |
| Swelling | 13.32 | 12.39 | 67 | 25549 | 418991 | 90183840 |
| Acute myocardial infarction | 13.25 | 12.39 | 30 | 25586 | 34860 | 90567971 |
| Cellulitis | 13.20 | 12.39 | 56 | 25560 | 91281 | 90511550 |
| Rash | 13.10 | 12.39 | 153 | 25463 | 795947 | 89806884 |
| Autoimmune disorder | 12.76 | 12.39 | 3 | 25613 | 76741 | 90526090 |
| Rheumatoid arthritis | 12.69 | 12.39 | 56 | 25560 | 362558 | 90240273 |
| Photosensitivity reaction | 12.63 | 12.39 | 20 | 25596 | 17787 | 90585044 |
| Comminuted fracture | 12.63 | 12.39 | 5 | 25611 | 532 | 90602299 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Asthma | 224.49 | 14.26 | 177 | 13974 | 62137 | 42545047 |
| Chronic obstructive pulmonary disease | 147.36 | 14.26 | 140 | 14011 | 62974 | 42544210 |
| Brain scan abnormal | 116.55 | 14.26 | 34 | 14117 | 1205 | 42605979 |
| Cerebral artery thrombosis | 116.28 | 14.26 | 34 | 14117 | 1215 | 42605969 |
| Dyspnoea | 102.16 | 14.26 | 350 | 13801 | 442271 | 42164913 |
| Fractional exhaled nitric oxide increased | 95.46 | 14.26 | 31 | 14120 | 1578 | 42605606 |
| Eosinophilic granulomatosis with polyangiitis | 87.38 | 14.26 | 47 | 14104 | 8591 | 42598593 |
| Wheezing | 83.78 | 14.26 | 97 | 14054 | 54684 | 42552500 |
| Areflexia | 83.11 | 14.26 | 35 | 14116 | 3708 | 42603476 |
| Plantar fasciitis | 79.35 | 14.26 | 32 | 14119 | 3038 | 42604146 |
| Myoglobin blood increased | 73.73 | 14.26 | 32 | 14119 | 3650 | 42603534 |
| Sensation of foreign body | 71.04 | 14.26 | 31 | 14120 | 3582 | 42603602 |
| Increased upper airway secretion | 70.77 | 14.26 | 28 | 14123 | 2528 | 42604656 |
| Obstructive airways disorder | 69.58 | 14.26 | 61 | 14090 | 24698 | 42582486 |
| Brain natriuretic peptide increased | 60.64 | 14.26 | 34 | 14117 | 6736 | 42600448 |
| Exostosis | 57.96 | 14.26 | 31 | 14120 | 5600 | 42601584 |
| Pneumonia | 53.92 | 14.26 | 279 | 13872 | 421870 | 42185314 |
| Hemiplegia | 53.30 | 14.26 | 33 | 14118 | 7846 | 42599338 |
| Product complaint | 50.79 | 14.26 | 29 | 14122 | 5948 | 42601236 |
| Product quality issue | 50.12 | 14.26 | 44 | 14107 | 17838 | 42589346 |
| Status asthmaticus | 49.36 | 14.26 | 13 | 14138 | 313 | 42606871 |
| Toxicity to various agents | 48.03 | 14.26 | 9 | 14142 | 229127 | 42378057 |
| Off label use | 46.26 | 14.26 | 89 | 14062 | 638246 | 41968938 |
| Dysphonia | 46.21 | 14.26 | 52 | 14099 | 28398 | 42578786 |
| Facial paralysis | 43.66 | 14.26 | 35 | 14116 | 12528 | 42594656 |
| Respiratory distress | 43.25 | 14.26 | 61 | 14090 | 41759 | 42565425 |
| Coronary artery disease | 42.28 | 14.26 | 69 | 14082 | 53651 | 42553533 |
| Bronchospasm | 40.79 | 14.26 | 34 | 14117 | 12851 | 42594333 |
| Ischaemic stroke | 38.45 | 14.26 | 42 | 14109 | 22191 | 42584993 |
| Foreign body in throat | 38.28 | 14.26 | 12 | 14139 | 544 | 42606640 |
| Pneumothorax | 38.17 | 14.26 | 43 | 14108 | 23500 | 42583684 |
| Eosinophilia | 35.52 | 14.26 | 49 | 14102 | 32850 | 42574334 |
| Hepatic cancer | 34.63 | 14.26 | 26 | 14125 | 8454 | 42598730 |
| Benign prostatic hyperplasia | 33.36 | 14.26 | 38 | 14113 | 21014 | 42586170 |
| Respiratory failure | 31.64 | 14.26 | 104 | 14047 | 128028 | 42479156 |
| Cough | 30.93 | 14.26 | 129 | 14022 | 177974 | 42429210 |
| Dyspnoea exertional | 29.85 | 14.26 | 57 | 14094 | 50091 | 42557093 |
| Cardiac disorder | 28.37 | 14.26 | 55 | 14096 | 48877 | 42558307 |
| Carcinoid tumour of the gastrointestinal tract | 27.52 | 14.26 | 6 | 14145 | 62 | 42607122 |
| Febrile neutropenia | 25.53 | 14.26 | 15 | 14136 | 185688 | 42421496 |
| Respiratory symptom | 24.66 | 14.26 | 24 | 14127 | 11082 | 42596102 |
| Drug abuse | 24.47 | 14.26 | 3 | 14148 | 104768 | 42502416 |
| Atrial fibrillation | 22.58 | 14.26 | 99 | 14052 | 139494 | 42467690 |
| Productive cough | 20.75 | 14.26 | 50 | 14101 | 51517 | 42555667 |
| Disease recurrence | 20.52 | 14.26 | 36 | 14115 | 29642 | 42577542 |
| Muscle spasms | 20.47 | 14.26 | 69 | 14082 | 85975 | 42521209 |
| Haemoptysis | 19.91 | 14.26 | 46 | 14105 | 46121 | 42561063 |
| Forced expiratory volume decreased | 19.84 | 14.26 | 18 | 14133 | 7612 | 42599572 |
| Secretion discharge | 19.83 | 14.26 | 18 | 14133 | 7617 | 42599567 |
| Cardiac failure congestive | 19.80 | 14.26 | 68 | 14083 | 85534 | 42521650 |
| Inhalation therapy | 19.61 | 14.26 | 4 | 14147 | 29 | 42607155 |
| Serratia infection | 18.98 | 14.26 | 9 | 14142 | 1260 | 42605924 |
| Nodule | 18.81 | 14.26 | 22 | 14129 | 12512 | 42594672 |
| Oral candidiasis | 17.92 | 14.26 | 23 | 14128 | 14382 | 42592802 |
| Hypoxia | 17.52 | 14.26 | 57 | 14094 | 69729 | 42537455 |
| Conjunctivitis allergic | 17.48 | 14.26 | 15 | 14136 | 5896 | 42601288 |
| Cerebrovascular accident | 17.32 | 14.26 | 71 | 14080 | 97089 | 42510095 |
| Carcinoid tumour of the stomach | 17.16 | 14.26 | 4 | 14147 | 57 | 42607127 |
| Sinusitis | 17.07 | 14.26 | 44 | 14107 | 47248 | 42559936 |
| Chest discomfort | 16.92 | 14.26 | 53 | 14098 | 63563 | 42543621 |
| COVID-19 | 16.45 | 14.26 | 9 | 14142 | 115939 | 42491245 |
| Nasopharyngitis | 16.27 | 14.26 | 63 | 14088 | 83933 | 42523251 |
| Peripheral swelling | 16.04 | 14.26 | 5 | 14146 | 90265 | 42516919 |
| Central nervous system mass | 15.75 | 14.26 | 7 | 14144 | 844 | 42606340 |
| Wall motion score index abnormal | 15.72 | 14.26 | 7 | 14144 | 848 | 42606336 |
| Eosinophilic pneumonia | 15.71 | 14.26 | 13 | 14138 | 4861 | 42602323 |
| Mycotic allergy | 15.67 | 14.26 | 13 | 14138 | 4878 | 42602306 |
| Airway remodelling | 15.38 | 14.26 | 7 | 14144 | 893 | 42606291 |
| Mite allergy | 15.32 | 14.26 | 13 | 14138 | 5033 | 42602151 |
| Spirometry abnormal | 15.09 | 14.26 | 13 | 14138 | 5133 | 42602051 |
| Cardiac septal defect | 14.95 | 14.26 | 7 | 14144 | 953 | 42606231 |
| Emphysema | 14.88 | 14.26 | 19 | 14132 | 11816 | 42595368 |
| Atopy | 14.84 | 14.26 | 7 | 14144 | 968 | 42606216 |
| Product use in unapproved indication | 14.81 | 14.26 | 24 | 14127 | 184432 | 42422752 |
| Dust allergy | 14.69 | 14.26 | 13 | 14138 | 5319 | 42601865 |
| Activated partial thromboplastin time prolonged | 14.69 | 14.26 | 22 | 14129 | 15881 | 42591303 |
| Lipohypertrophy | 14.63 | 14.26 | 5 | 14146 | 298 | 42606886 |
| Blood immunoglobulin E increased | 14.55 | 14.26 | 11 | 14140 | 3614 | 42603570 |
| Post streptococcal glomerulonephritis | 14.51 | 14.26 | 4 | 14147 | 115 | 42607069 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Asthma | 267.00 | 12.81 | 345 | 31671 | 249946 | 110307337 |
| Chronic obstructive pulmonary disease | 264.73 | 12.81 | 233 | 31783 | 108925 | 110448358 |
| Eosinophilic granulomatosis with polyangiitis | 206.49 | 12.81 | 87 | 31929 | 10599 | 110546684 |
| Dyspnoea | 203.42 | 12.81 | 741 | 31275 | 1106131 | 109451152 |
| Multi-organ disorder | 116.89 | 12.81 | 42 | 31974 | 3339 | 110553944 |
| Brain scan abnormal | 113.16 | 12.81 | 34 | 31982 | 1537 | 110555746 |
| Chest discomfort | 111.71 | 12.81 | 189 | 31827 | 173659 | 110383624 |
| Cerebral artery thrombosis | 106.91 | 12.81 | 33 | 31983 | 1635 | 110555648 |
| Pneumonia | 92.41 | 12.81 | 498 | 31518 | 876216 | 109681067 |
| Increased upper airway secretion | 89.22 | 12.81 | 39 | 31977 | 5193 | 110552090 |
| Cardiac failure congestive | 86.37 | 12.81 | 156 | 31860 | 150844 | 110406439 |
| Eye haemorrhage | 85.05 | 12.81 | 49 | 31967 | 11725 | 110545558 |
| Cough | 82.44 | 12.81 | 307 | 31709 | 461334 | 110095949 |
| Ventilation perfusion mismatch | 78.50 | 12.81 | 22 | 31994 | 775 | 110556508 |
| Fractional exhaled nitric oxide increased | 74.52 | 12.81 | 21 | 31995 | 755 | 110556528 |
| Off label use | 72.51 | 12.81 | 210 | 31806 | 1499975 | 109057308 |
| Product complaint | 72.35 | 12.81 | 47 | 31969 | 13925 | 110543358 |
| Bronchospasm | 68.17 | 12.81 | 62 | 31954 | 30177 | 110527106 |
| Wheezing | 65.45 | 12.81 | 192 | 31824 | 255038 | 110302245 |
| Product quality issue | 64.81 | 12.81 | 95 | 31921 | 77204 | 110480079 |
| Thyroid disorder | 64.08 | 12.81 | 47 | 31969 | 16922 | 110540361 |
| Areflexia | 62.16 | 12.81 | 33 | 31983 | 6736 | 110550547 |
| Status asthmaticus | 60.40 | 12.81 | 19 | 31997 | 1002 | 110556281 |
| Bronchitis | 56.44 | 12.81 | 134 | 31882 | 156898 | 110400385 |
| Obstructive airways disorder | 56.06 | 12.81 | 68 | 31948 | 46081 | 110511202 |
| Malnutrition | 53.93 | 12.81 | 52 | 31964 | 27227 | 110530056 |
| Intentional product use issue | 53.52 | 12.81 | 5 | 32011 | 247901 | 110309382 |
| Pemphigus | 50.08 | 12.81 | 3 | 32013 | 214567 | 110342716 |
| Toxicity to various agents | 49.42 | 12.81 | 40 | 31976 | 480515 | 110076768 |
| Productive cough | 48.26 | 12.81 | 104 | 31912 | 114201 | 110443082 |
| Analgesic therapy | 46.53 | 12.81 | 28 | 31988 | 7256 | 110550027 |
| Drug therapy | 46.51 | 12.81 | 28 | 31988 | 7263 | 110550020 |
| Haemoptysis | 46.34 | 12.81 | 78 | 31938 | 71276 | 110486007 |
| Coronary artery disease | 46.07 | 12.81 | 78 | 31938 | 71612 | 110485671 |
| Anticoagulant therapy | 46.04 | 12.81 | 25 | 31991 | 5336 | 110551947 |
| Antacid therapy | 45.51 | 12.81 | 25 | 31991 | 5459 | 110551824 |
| Dysphonia | 45.38 | 12.81 | 80 | 31936 | 75849 | 110481434 |
| Psoriatic arthropathy | 45.18 | 12.81 | 3 | 32013 | 196758 | 110360525 |
| Activated partial thromboplastin time prolonged | 44.90 | 12.81 | 43 | 31973 | 22325 | 110534958 |
| Chest pain | 44.44 | 12.81 | 221 | 31795 | 376154 | 110181129 |
| Systemic lupus erythematosus | 43.73 | 12.81 | 10 | 32006 | 254328 | 110302955 |
| Pericarditis | 43.34 | 12.81 | 6 | 32010 | 219108 | 110338175 |
| Myoglobin blood increased | 42.77 | 12.81 | 22 | 31994 | 4210 | 110553073 |
| Plantar fasciitis | 41.63 | 12.81 | 23 | 31993 | 5078 | 110552205 |
| Respiratory failure | 41.55 | 12.81 | 147 | 31869 | 215185 | 110342098 |
| Hypoxia | 40.69 | 12.81 | 105 | 31911 | 129410 | 110427873 |
| Myocardial infarction | 39.56 | 12.81 | 134 | 31882 | 191949 | 110365334 |
| Completed suicide | 38.84 | 12.81 | 11 | 32005 | 242370 | 110314913 |
| Product use in unapproved indication | 38.13 | 12.81 | 44 | 31972 | 447333 | 110109950 |
| Cerebrovascular accident | 37.80 | 12.81 | 127 | 31889 | 181157 | 110376126 |
| Impaired healing | 37.49 | 12.81 | 6 | 32010 | 196711 | 110360572 |
| Drug abuse | 37.19 | 12.81 | 4 | 32012 | 177407 | 110379876 |
| COVID-19 | 35.94 | 12.81 | 13 | 32003 | 245047 | 110312236 |
| Respiratory distress | 35.40 | 12.81 | 68 | 31948 | 68806 | 110488477 |
| Peripheral swelling | 35.23 | 12.81 | 39 | 31977 | 403995 | 110153288 |
| Facial paralysis | 34.96 | 12.81 | 39 | 31977 | 24175 | 110533108 |
| Myalgia | 34.80 | 12.81 | 142 | 31874 | 222239 | 110335044 |
| Benign prostatic hyperplasia | 34.62 | 12.81 | 34 | 31982 | 18200 | 110539083 |
| Sensation of foreign body | 34.51 | 12.81 | 24 | 31992 | 7951 | 110549332 |
| Febrile neutropenia | 34.28 | 12.81 | 25 | 31991 | 316742 | 110240541 |
| Pulmonary oedema | 33.06 | 12.81 | 83 | 31933 | 100576 | 110456707 |
| Liver injury | 32.55 | 12.81 | 3 | 32013 | 150410 | 110406873 |
| Foreign body in throat | 32.27 | 12.81 | 12 | 32004 | 1051 | 110556232 |
| Tremor | 31.53 | 12.81 | 129 | 31887 | 202103 | 110355180 |
| International normalised ratio increased | 31.11 | 12.81 | 74 | 31942 | 86698 | 110470585 |
| Hyperphosphataemia | 30.09 | 12.81 | 30 | 31986 | 16351 | 110540932 |
| Arthropathy | 29.45 | 12.81 | 24 | 31992 | 287498 | 110269785 |
| Blood calcium increased | 29.44 | 12.81 | 31 | 31985 | 18009 | 110539274 |
| Brain natriuretic peptide increased | 29.30 | 12.81 | 25 | 31991 | 11184 | 110546099 |
| Inhalation therapy | 29.09 | 12.81 | 6 | 32010 | 54 | 110557229 |
| Glossodynia | 28.97 | 12.81 | 14 | 32002 | 221990 | 110335293 |
| Fibromyalgia | 28.82 | 12.81 | 7 | 32009 | 170902 | 110386381 |
| Pericardial effusion | 28.80 | 12.81 | 56 | 31960 | 57161 | 110500122 |
| Diabetes mellitus | 28.60 | 12.81 | 78 | 31938 | 99303 | 110457980 |
| Hemiplegia | 28.37 | 12.81 | 34 | 31982 | 22748 | 110534535 |
| Temperature regulation disorder | 28.32 | 12.81 | 26 | 31990 | 12800 | 110544483 |
| Laryngeal pain | 28.27 | 12.81 | 19 | 31997 | 5956 | 110551327 |
| Aortic stenosis | 27.92 | 12.81 | 26 | 31990 | 13033 | 110544250 |
| Irritable bowel syndrome | 27.16 | 12.81 | 7 | 32009 | 164208 | 110393075 |
| C-reactive protein increased | 26.58 | 12.81 | 15 | 32001 | 217904 | 110339379 |
| Pulmonary embolism | 26.04 | 12.81 | 127 | 31889 | 214347 | 110342936 |
| Sputum discoloured | 25.85 | 12.81 | 36 | 31980 | 27909 | 110529374 |
| Therapeutic product effect decreased | 25.51 | 12.81 | 20 | 31996 | 244296 | 110312987 |
| Stress fracture | 25.03 | 12.81 | 19 | 31997 | 7202 | 110550081 |
| Blood phosphorus increased | 24.77 | 12.81 | 27 | 31989 | 16313 | 110540970 |
| Dysmetropsia | 24.61 | 12.81 | 6 | 32010 | 121 | 110557162 |
| Hyperlipidaemia | 24.36 | 12.81 | 40 | 31976 | 35808 | 110521475 |
| Appendicolith | 24.17 | 12.81 | 25 | 31991 | 14230 | 110543053 |
| Acute respiratory failure | 23.61 | 12.81 | 61 | 31955 | 75199 | 110482084 |
| Food allergy | 23.58 | 12.81 | 29 | 31987 | 19919 | 110537364 |
| Carcinoid tumour of the gastrointestinal tract | 23.46 | 12.81 | 6 | 32010 | 148 | 110557135 |
| Respiratory symptom | 23.19 | 12.81 | 25 | 31991 | 14920 | 110542363 |
| Alopecia | 23.14 | 12.81 | 44 | 31972 | 364709 | 110192574 |
| Arteriosclerosis | 23.05 | 12.81 | 32 | 31984 | 24735 | 110532548 |
| Joint range of motion decreased | 22.58 | 12.81 | 4 | 32012 | 121828 | 110435455 |
| Spirometry abnormal | 22.52 | 12.81 | 16 | 32000 | 5481 | 110551802 |
| Sleep disorder therapy | 22.31 | 12.81 | 18 | 31998 | 7453 | 110549830 |
| Erysipelas | 22.17 | 12.81 | 23 | 31993 | 13135 | 110544148 |
| Pneumothorax | 22.15 | 12.81 | 38 | 31978 | 35247 | 110522036 |
| Fracture displacement | 21.98 | 12.81 | 10 | 32006 | 1462 | 110555821 |
| Foetal death | 21.73 | 12.81 | 25 | 31991 | 16020 | 110541263 |
| Mobility decreased | 21.71 | 12.81 | 22 | 31994 | 237400 | 110319883 |
| Infective pulmonary exacerbation of cystic fibrosis | 21.68 | 12.81 | 24 | 31992 | 14747 | 110542536 |
| Hepatic cancer | 21.55 | 12.81 | 21 | 31995 | 11135 | 110546148 |
| Nasal oedema | 21.54 | 12.81 | 17 | 31999 | 6822 | 110550461 |
| Ischaemic stroke | 21.52 | 12.81 | 41 | 31975 | 41222 | 110516061 |
| Abdominal discomfort | 21.26 | 12.81 | 52 | 31964 | 393806 | 110163477 |
| Intentional overdose | 21.24 | 12.81 | 6 | 32010 | 132495 | 110424788 |
| Cortisol decreased | 21.01 | 12.81 | 12 | 32004 | 2824 | 110554459 |
| Bacterial infection | 20.71 | 12.81 | 43 | 31973 | 45993 | 110511290 |
| Palpitations | 20.57 | 12.81 | 96 | 31920 | 159116 | 110398167 |
| End stage renal disease | 20.36 | 12.81 | 28 | 31988 | 21445 | 110535838 |
| Varicella zoster oesophagitis | 20.28 | 12.81 | 4 | 32012 | 28 | 110557255 |
| Cardiac disorder | 20.11 | 12.81 | 58 | 31958 | 76222 | 110481061 |
| Dyspnoea exertional | 20.02 | 12.81 | 71 | 31945 | 103989 | 110453294 |
| Malignant neoplasm progression | 19.91 | 12.81 | 13 | 32003 | 174554 | 110382729 |
| Discomfort | 19.51 | 12.81 | 20 | 31996 | 214687 | 110342596 |
| Rash erythematous | 19.47 | 12.81 | 60 | 31956 | 81772 | 110475511 |
| Eosinophilia | 19.26 | 12.81 | 48 | 31968 | 57888 | 110499395 |
| Upper respiratory tract infection | 19.08 | 12.81 | 82 | 31934 | 131246 | 110426037 |
| Neutropenia | 19.03 | 12.81 | 51 | 31965 | 374569 | 110182714 |
| Varicella zoster gastritis | 19.01 | 12.81 | 4 | 32012 | 40 | 110557243 |
| Wound | 18.95 | 12.81 | 24 | 31992 | 234413 | 110322870 |
| Central obesity | 18.90 | 12.81 | 10 | 32006 | 2026 | 110555257 |
| Blood uric acid increased | 18.82 | 12.81 | 27 | 31989 | 21502 | 110535781 |
| Forced expiratory volume decreased | 18.64 | 12.81 | 21 | 31995 | 13155 | 110544128 |
| Stomatitis | 18.57 | 12.81 | 31 | 31985 | 270211 | 110287072 |
| Throat irritation | 18.47 | 12.81 | 45 | 31971 | 53507 | 110503776 |
| Derealisation | 18.36 | 12.81 | 10 | 32006 | 2148 | 110555135 |
| Oral candidiasis | 18.06 | 12.81 | 40 | 31976 | 44720 | 110512563 |
| Treatment failure | 17.97 | 12.81 | 33 | 31983 | 277201 | 110280082 |
| Emphysema | 17.60 | 12.81 | 25 | 31991 | 19731 | 110537552 |
| Thrombosis | 17.47 | 12.81 | 70 | 31946 | 108592 | 110448691 |
| Mite allergy | 17.37 | 12.81 | 14 | 32002 | 5789 | 110551494 |
| Lung opacity | 17.22 | 12.81 | 19 | 31997 | 11633 | 110545650 |
| Epilepsy | 17.10 | 12.81 | 4 | 32012 | 100205 | 110457078 |
| Blood test abnormal | 16.94 | 12.81 | 30 | 31986 | 28524 | 110528759 |
| Atrial fibrillation | 16.81 | 12.81 | 119 | 31897 | 229523 | 110327760 |
| Inflammation | 16.45 | 12.81 | 19 | 31997 | 193219 | 110364064 |
| Gastrointestinal disorder | 16.40 | 12.81 | 28 | 31988 | 241924 | 110315359 |
| Gout | 16.27 | 12.81 | 34 | 31982 | 36532 | 110520751 |
| Hypercapnia | 16.15 | 12.81 | 18 | 31998 | 11141 | 110546142 |
| Oedema peripheral | 15.84 | 12.81 | 155 | 31861 | 328505 | 110228778 |
| Emotional distress | 15.80 | 12.81 | 38 | 31978 | 44809 | 110512474 |
| Total lung capacity abnormal | 15.75 | 12.81 | 12 | 32004 | 4571 | 110552712 |
| Infusion related reaction | 15.74 | 12.81 | 57 | 31959 | 381105 | 110176178 |
| Appendicitis | 15.74 | 12.81 | 29 | 31987 | 28435 | 110528848 |
| Contraindicated product administered | 15.69 | 12.81 | 30 | 31986 | 248237 | 110309046 |
| Lipohypertrophy | 15.55 | 12.81 | 7 | 32009 | 999 | 110556284 |
| Uterine hypertonus | 15.52 | 12.81 | 5 | 32011 | 285 | 110556998 |
| Middle insomnia | 15.47 | 12.81 | 24 | 31992 | 20478 | 110536805 |
| Serratia infection | 15.25 | 12.81 | 9 | 32007 | 2250 | 110555033 |
| Mycotic allergy | 14.99 | 12.81 | 13 | 32003 | 5941 | 110551342 |
| Granuloma | 14.94 | 12.81 | 16 | 32000 | 9474 | 110547809 |
| Post streptococcal glomerulonephritis | 14.92 | 12.81 | 4 | 32012 | 119 | 110557164 |
| Dust allergy | 14.90 | 12.81 | 13 | 32003 | 5988 | 110551295 |
| Pulseless electrical activity | 14.63 | 12.81 | 21 | 31995 | 16736 | 110540547 |
| Calculus bladder | 14.52 | 12.81 | 8 | 32008 | 1756 | 110555527 |
| Peroneal nerve injury | 14.35 | 12.81 | 4 | 32012 | 138 | 110557145 |
| Pulmonary vasculitis | 13.91 | 12.81 | 13 | 32003 | 6547 | 110550736 |
| Aspergilloma | 13.77 | 12.81 | 6 | 32010 | 793 | 110556490 |
| Blood glucose increased | 13.67 | 12.81 | 75 | 31941 | 132421 | 110424862 |
| Pulmonary mass | 13.57 | 12.81 | 32 | 31984 | 37269 | 110520014 |
| Central nervous system mass | 13.52 | 12.81 | 6 | 32010 | 828 | 110556455 |
| Anxiety | 13.48 | 12.81 | 156 | 31860 | 344922 | 110212361 |
| Wall motion score index abnormal | 13.47 | 12.81 | 6 | 32010 | 835 | 110556448 |
| Conjunctivitis allergic | 13.30 | 12.81 | 13 | 32003 | 6918 | 110550365 |
| Cholecystitis chronic | 13.20 | 12.81 | 15 | 32001 | 9485 | 110547798 |
| Carcinoid tumour of the stomach | 13.16 | 12.81 | 4 | 32012 | 188 | 110557095 |
| Hyperhidrosis | 13.09 | 12.81 | 96 | 31920 | 187202 | 110370081 |
| Joint swelling | 13.04 | 12.81 | 75 | 31941 | 442770 | 110114513 |
| Diffuse panbronchiolitis | 12.96 | 12.81 | 3 | 32013 | 48 | 110557235 |
| Eosinophilic pneumonia | 12.84 | 12.81 | 13 | 32003 | 7214 | 110550069 |
| Airway remodelling | 12.82 | 12.81 | 6 | 32010 | 936 | 110556347 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | R03AC12 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Selective beta-2-adrenoreceptor agonists |
| ATC | R03AK06 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics |
| ATC | R03AK12 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics |
| FDA MoA | N0000009922 | Adrenergic beta2-Agonists |
| 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 |
| FDA EPC | N0000175779 | beta2-Adrenergic Agonist |
| CHEBI has role | CHEBI:35522 | ฮฒ-adrenergic agonist |
| CHEBI has role | CHEBI:35523 | bronchodilator agent |
| CHEBI has role | CHEBI:65023 | anti-asthmatic agent |
| CHEBI has role | CHEBI:53784 | antispasmodic drug |
| CHEBI has role | CHEBI:74518 | anti-obesity agent |
Related Drugs by ATC class:
R03AC Selective beta-2-adrenoreceptor agonists 17 drugs
R03AK Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics 13 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Pulmonary emphysema | indication | 87433001 | |
| Non-allergic asthma | indication | 266361008 | DOID:9360 |
| Allergic asthma | indication | 389145006 | DOID:9415 |
| Adjunct Therapy to Achieve Long-term Asthma Control | indication | ||
| Bronchospasm Prevention with COPD | indication | ||
| Exercise-Induced Bronchospasm Prevention | indication | ||
| COPD Associated with Chronic Bronchitis | indication | ||
| Mycosis | contraindication | 3218000 | DOID:1564 |
| Disease caused by parasite | contraindication | 17322007 | |
| Glaucoma | contraindication | 23986001 | DOID:1686 |
| Acute tuberculosis | contraindication | 25629007 | |
| Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
| Hypokalemia | contraindication | 43339004 | |
| Conduction disorder of the heart | contraindication | 44808001 | |
| Ketoacidosis | contraindication | 56051008 | |
| Osteoporosis | contraindication | 64859006 | DOID:11476 |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Hypopituitarism | contraindication | 74728003 | DOID:9406 |
| Candidiasis of mouth | contraindication | 79740000 | DOID:14262 |
| Hyperglycemia | contraindication | 80394007 | DOID:4195 |
| Thyrotoxicosis | contraindication | 90739004 | DOID:7997 |
| Bilateral cataracts | contraindication | 95722004 | |
| Prolonged QT interval | contraindication | 111975006 | |
| Seizure disorder | contraindication | 128613002 | |
| Ophthalmic herpes simplex | contraindication | 186542001 | |
| Exacerbation of asthma | contraindication | 281239006 | |
| Osteopenia | contraindication | 312894000 | |
| Chronic myocardial ischemia | contraindication | 413844008 | DOID:3393 |
| Congenital long QT syndrome | contraindication | 442917000 | |
| Uncontrolled Bacterial Infections | contraindication |
๐ถ Veterinary Drug Use
None
๐ถ Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 10.07 | acidic |
| pKa2 | 9.28 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.055MG/INH;EQ 0.014MG BASE/INH | AIRDUO DIGIHALER | TEVA PHARM | N208799 | July 12, 2019 | DISCN | POWDER | INHALATION | 9066957 | Oct. 6, 2034 | TREATMENT OF ASTHMA |
| 0.055MG/INH;EQ 0.014MG BASE/INH | AIRDUO RESPICLICK | TEVA PHARM | N208799 | Jan. 27, 2017 | RX | POWDER | INHALATION | 9066957 | Oct. 6, 2034 | TREATMENT OF ASTHMA |
| 0.055MG/INH;EQ 0.014MG BASE/INH | AIRDUO DIGIHALER | TEVA PHARM | N208799 | July 12, 2019 | DISCN | POWDER | INHALATION | 9415008 | Oct. 6, 2034 | TREATMENT OF ASTHMA |
| 0.055MG/INH;EQ 0.014MG BASE/INH | AIRDUO RESPICLICK | TEVA PHARM | N208799 | Jan. 27, 2017 | RX | POWDER | INHALATION | 9415008 | Oct. 6, 2034 | TREATMENT OF ASTHMA |
| 0.113MG/INH;EQ 0.014MG BASE/INH | AIRDUO DIGIHALER | TEVA PHARM | N208799 | July 12, 2019 | DISCN | POWDER | INHALATION | 9066957 | Oct. 6, 2034 | TREATMENT OF ASTHMA |
| 0.113MG/INH;EQ 0.014MG BASE/INH | AIRDUO RESPICLICK | TEVA PHARM | N208799 | Jan. 27, 2017 | RX | POWDER | INHALATION | 9066957 | Oct. 6, 2034 | TREATMENT OF ASTHMA |
| 0.232MG/INH;EQ 0.014MG BASE/INH | AIRDUO DIGIHALER | TEVA PHARM | N208799 | July 12, 2019 | DISCN | POWDER | INHALATION | 9066957 | Oct. 6, 2034 | TREATMENT OF ASTHMA |
| 0.232MG/INH;EQ 0.014MG BASE/INH | AIRDUO RESPICLICK | TEVA PHARM | N208799 | Jan. 27, 2017 | RX | POWDER | INHALATION | 9066957 | Oct. 6, 2034 | TREATMENT OF ASTHMA |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Beta-2 adrenergic receptor | GPCR | AGONIST | Ki | 9.41 | CHEMBL | CHEMBL | |||
| D(2) dopamine receptor | GPCR | Ki | 4.50 | CHEMBL | |||||
| Sodium-dependent serotonin transporter | Transporter | Ki | 6.53 | CHEMBL | |||||
| Sodium-dependent noradrenaline transporter | Transporter | Ki | 6.42 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 2A | GPCR | Ki | 5.89 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 2C | GPCR | Ki | 5.39 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 7 | GPCR | Ki | 6.59 | CHEMBL | |||||
| Alpha-1A adrenergic receptor | GPCR | Ki | 6.26 | CHEMBL | |||||
| Alpha-2B adrenergic receptor | GPCR | Ki | 5.71 | CHEMBL | |||||
| D(3) dopamine receptor | GPCR | Ki | 5.98 | CHEMBL | |||||
| Muscarinic acetylcholine receptor M5 | GPCR | Ki | 6.01 | CHEMBL | |||||
| Aldehyde oxidase | Enzyme | IC50 | 5.00 | WOMBAT-PK | |||||
| Beta-3 adrenergic receptor | GPCR | EC50 | 6 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 1B | GPCR | Ki | 5.70 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 1D | GPCR | Ki | 5.99 | CHEMBL | |||||
| Sodium-dependent dopamine transporter | Transporter | Ki | 6.83 | CHEMBL | |||||
| D(4) dopamine receptor | GPCR | Ki | 5.97 | CHEMBL | |||||
| Alpha-1D adrenergic receptor | GPCR | Ki | 6.02 | CHEMBL | |||||
| Beta-1 adrenergic receptor | GPCR | Ki | 6.10 | CHEMBL | |||||
| Transmembrane protein 97 | Enzyme | Ki | 7.49 | CHEMBL | |||||
| Beta-2 adrenergic receptor | GPCR | EC50 | 7.50 | CHEMBL | |||||
| Beta-1 adrenergic receptor | GPCR | Ki | 6.26 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4023955 | VUID |
| N0000021960 | NUI |
| D00687 | KEGG_DRUG |
| 94749-08-3 | SECONDARY_CAS_RN |
| 4020873 | VANDF |
| 4023955 | VANDF |
| C0245531 | UMLSCUI |
| CHEBI:9011 | CHEBI |
| K5Y | PDB_CHEM_ID |
| CHEMBL1263 | ChEMBL_ID |
| CHEMBL1082607 | ChEMBL_ID |
| D000068299 | MESH_DESCRIPTOR_UI |
| DB00938 | DRUGBANK_ID |
| 5152 | PUBCHEM_CID |
| 559 | IUPHAR_LIGAND_ID |
| 5578 | INN_ID |
| 2I4BC502BT | UNII |
| 203159 | RXNORM |
| 1605 | MMSL |
| 21564 | MMSL |
| 5440 | MMSL |
| d03759 | MMSL |
| 004036 | NDDF |
| 004037 | NDDF |
| 108605008 | SNOMEDCT_US |
| 108606009 | SNOMEDCT_US |
| 372515005 | SNOMEDCT_US |
| 2I4BC502BT | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| fluticasone propionate and salmeterol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0054-0326 | POWDER | 50 ug | RESPIRATORY (INHALATION) | ANDA | 28 sections |
| fluticasone propionate and salmeterol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0054-0327 | POWDER | 50 ug | RESPIRATORY (INHALATION) | ANDA | 28 sections |
| fluticasone propionate and salmeterol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0054-0328 | POWDER | 50 ug | RESPIRATORY (INHALATION) | ANDA | 28 sections |
| Fluticasone Propionate and Salmeterol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0093-3607 | POWDER, METERED | 14 ug | RESPIRATORY (INHALATION) | NDA authorized generic | 31 sections |
| Fluticasone Propionate and Salmeterol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0093-3608 | POWDER, METERED | 14 ug | RESPIRATORY (INHALATION) | NDA authorized generic | 31 sections |
| Fluticasone Propionate and Salmeterol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0093-3609 | POWDER, METERED | 14 ug | RESPIRATORY (INHALATION) | NDA authorized generic | 31 sections |
| fluticasone propionate and salmeterol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0093-7516 | POWDER | 50 ug | RESPIRATORY (INHALATION) | ANDA | 28 sections |
| fluticasone propionate and salmeterol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0093-7517 | POWDER | 50 ug | RESPIRATORY (INHALATION) | ANDA | 28 sections |
| fluticasone propionate and salmeterol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0093-7518 | POWDER | 50 ug | RESPIRATORY (INHALATION) | ANDA | 28 sections |
| SEREVENTDISKUS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0173-0521 | POWDER, METERED | 50 ug | RESPIRATORY (INHALATION) | NDA | 29 sections |
| ADVAIRDISKUS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0173-0695 | POWDER | 50 ug | RESPIRATORY (INHALATION) | NDA | 27 sections |
| ADVAIRDISKUS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0173-0696 | POWDER | 50 ug | RESPIRATORY (INHALATION) | NDA | 27 sections |
| ADVAIRDISKUS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0173-0697 | POWDER | 50 ug | RESPIRATORY (INHALATION) | NDA | 27 sections |
| ADVAIR HFA | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0173-0715 | AEROSOL, METERED | 21 ug | RESPIRATORY (INHALATION) | NDA | 28 sections |
| ADVAIR HFA | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0173-0716 | AEROSOL, METERED | 21 ug | RESPIRATORY (INHALATION) | NDA | 28 sections |
| ADVAIR HFA | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0173-0717 | AEROSOL, METERED | 21 ug | RESPIRATORY (INHALATION) | NDA | 28 sections |
| Wixela Inhub | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-9320 | POWDER | 50 ug | RESPIRATORY (INHALATION) | ANDA | 30 sections |
| Wixela Inhub | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-9321 | POWDER | 50 ug | RESPIRATORY (INHALATION) | ANDA | 30 sections |
| Wixela Inhub | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-9322 | POWDER | 50 ug | RESPIRATORY (INHALATION) | ANDA | 30 sections |
| Fluticasone Propionate and Salmeterol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0527-6010 | POWDER | 50 ug | RESPIRATORY (INHALATION) | ANDA | 27 sections |
| Fluticasone Propionate and Salmeterol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0527-6011 | POWDER | 50 ug | RESPIRATORY (INHALATION) | ANDA | 27 sections |
| ADVAIRDISKUS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 21695-196 | POWDER | 50 ug | RESPIRATORY (INHALATION) | NDA | 30 sections |
| ADVAIRDISKUS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 21695-197 | POWDER | 50 ug | RESPIRATORY (INHALATION) | NDA | 30 sections |
| ADVAIRDISKUS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 21695-361 | POWDER | 50 ug | RESPIRATORY (INHALATION) | NDA | 30 sections |
| ADVAIRDISKUS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 33261-873 | POWDER | 50 ug | RESPIRATORY (INHALATION) | NDA | 29 sections |
| ADVAIRDISKUS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 33261-874 | POWDER | 50 ug | RESPIRATORY (INHALATION) | NDA | 29 sections |
| ADVAIRDISKUS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50090-0730 | POWDER | 50 ug | RESPIRATORY (INHALATION) | NDA | 28 sections |
| ADVAIRDISKUS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50090-0731 | POWDER | 50 ug | RESPIRATORY (INHALATION) | NDA | 28 sections |
| ADVAIRDISKUS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50090-0731 | POWDER | 0.05 mg | RESPIRATORY (INHALATION) | NDA | 28 sections |
| ADVAIRDISKUS | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50090-0732 | POWDER | 50 ug | RESPIRATORY (INHALATION) | NDA | 28 sections |