ciclesonide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
steroids for topical use, acetal derivatives 633 126544-47-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ciclesonide
  • omnaris
  • alvesco
nasal spray approved for seasonal and perennial allergic rhinitis
  • Molecular weight: 540.70
  • Formula: C32H44O7
  • CLOGP: 5.25
  • LIPINSKI: 2
  • HAC: 7
  • HDO: 1
  • TPSA: 99.13
  • ALOGS: -5.54
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.20 mg N
0.16 mg Inhal.aerosol

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.00 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 1 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 2.90 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 33.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.04 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Oct. 20, 2006 FDA TAKEDA GMBH

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 2636.93 18.19 1326 34350 126235 63327111
Wheezing 1666.62 18.19 888 34788 94707 63358639
Obstructive airways disorder 1172.77 18.19 440 35236 20259 63433087
Sleep disorder due to a general medical condition 857.15 18.19 304 35372 11884 63441462
Therapeutic product effect incomplete 655.17 18.19 550 35126 124506 63328840
Dyspnoea 615.82 18.19 1223 34453 660090 62793256
Full blood count abnormal 535 18.19 289 35387 31428 63421918
Cough 513.33 18.19 721 34955 292022 63161324
Productive cough 489.97 18.19 351 35325 62857 63390489
Sputum discoloured 435.11 18.19 203 35473 16144 63437202
Forced expiratory volume decreased 399.43 18.19 137 35539 4831 63448515
Loss of personal independence in daily activities 357.58 18.19 351 35325 96939 63356407
Chest discomfort 346.36 18.19 365 35311 109604 63343742
Pneumonia viral 289.88 18.19 123 35553 7799 63445547
Middle insomnia 284.68 18.19 140 35536 12503 63440843
Soft tissue disorder 207.29 18.19 82 35594 4340 63449006
Nasal polyps 198.73 18.19 87 35589 5952 63447394
Rhinitis 189.91 18.19 103 35573 11263 63442083
Asthma-chronic obstructive pulmonary disease overlap syndrome 182.02 18.19 61 35615 2000 63451346
Bronchial wall thickening 175.72 18.19 55 35621 1444 63451902
Breath sounds abnormal 168.35 18.19 94 35582 10879 63442467
Bronchial secretion retention 167.99 18.19 62 35614 2711 63450635
Bacterial disease carrier 165.12 18.19 51 35625 1280 63452066
Total lung capacity increased 163.72 18.19 58 35618 2252 63451094
Bronchiectasis 149.20 18.19 100 35576 16042 63437304
Nasal congestion 147.25 18.19 183 35493 65477 63387869
Lung diffusion test abnormal 142.08 18.19 34 35642 309 63453037
Sleep apnoea syndrome 137.56 18.19 121 35555 29012 63424334
Blood immunoglobulin E increased 134.97 18.19 58 35618 3791 63449555
Sputum purulent 127.91 18.19 40 35636 1047 63452299
Herpes zoster 127.57 18.19 192 35484 82270 63371076
Restrictive pulmonary disease 126.95 18.19 45 35631 1750 63451596
Sarcoidosis 123.04 18.19 66 35610 7056 63446290
Rhinitis allergic 121.42 18.19 78 35598 11649 63441697
Dyspnoea exertional 120.91 18.19 159 35517 60143 63393203
Arthritis 120.65 18.19 226 35450 115695 63337651
Eosinophilia 120.63 18.19 101 35575 22655 63430691
Gastrooesophageal reflux disease 115.55 18.19 199 35477 95440 63357906
Off label use 114.04 18.19 127 35549 674335 62779011
Heart rate increased 111.13 18.19 194 35482 94044 63359302
Diarrhoea 111.09 18.19 144 35532 715222 62738124
Blood test abnormal 110.04 18.19 82 35594 15547 63437799
Chronic obstructive pulmonary disease 108.60 18.19 154 35522 62532 63390814
Bronchial neoplasm 105.76 18.19 29 35647 471 63452875
Bronchial haemorrhage 105.40 18.19 30 35646 562 63452784
Bronchial disorder 105.33 18.19 36 35640 1254 63452092
Toxicity to various agents 102.86 18.19 10 35666 247240 63206106
Nasal turbinate hypertrophy 102.15 18.19 31 35645 732 63452614
Death 101.10 18.19 42 35634 374339 63079007
Superinfection 100.43 18.19 42 35634 2565 63450781
Infusion related reaction 99.37 18.19 11 35665 245510 63207836
Hyper IgE syndrome 96.03 18.19 27 35649 483 63452863
Acute kidney injury 94.47 18.19 17 35659 263398 63189948
Illness 93.18 18.19 126 35550 48933 63404413
Bronchospasm 92.21 18.19 77 35599 17203 63436143
Oral pain 90.53 18.19 95 35581 28299 63425047
Nasopharyngitis 90.47 18.19 331 35345 253926 63199420
Crepitations 89.52 18.19 56 35620 7984 63445362
Endometrial ablation 86.98 18.19 29 35647 935 63452411
Arthropathy 86.73 18.19 14 35662 234778 63218568
Throat clearing 86.62 18.19 37 35639 2382 63450964
Idiopathic intracranial hypertension 86.09 18.19 39 35637 2892 63450454
Upper-airway cough syndrome 85.10 18.19 62 35614 11356 63441990
Respiratory tract congestion 84.04 18.19 74 35602 17758 63435588
Blood pressure increased 83.95 18.19 240 35436 161822 63291524
Drug interaction 83.88 18.19 14 35662 229117 63224229
Pulmonary function test decreased 83.77 18.19 42 35634 3905 63449441
Secretion discharge 83.50 18.19 63 35613 12168 63441178
Influenza 80.17 18.19 184 35492 108538 63344808
Rash 78.86 18.19 121 35555 560750 62892596
Glaucoma 78.38 18.19 73 35603 18832 63434514
Sinus operation 77.83 18.19 35 35641 2551 63450795
Contraindicated product administered 75.99 18.19 15 35661 217633 63235713
Pneumonia 75.97 18.19 477 35199 456290 62997056
Factor V Leiden mutation 75.87 18.19 19 35657 212 63453134
Glossodynia 74.99 18.19 7 35669 178869 63274477
Asthma exercise induced 74.54 18.19 20 35656 298 63453048
Broncholithiasis 74.16 18.19 19 35657 234 63453112
Hand deformity 73.27 18.19 4 35672 159453 63293893
Confusional state 73.27 18.19 21 35655 236359 63216987
Treatment failure 73.20 18.19 12 35664 199031 63254315
Rib deformity 72.31 18.19 19 35657 260 63453086
Cardiac murmur 71.82 18.19 62 35614 14490 63438856
Ventricular failure 70.81 18.19 20 35656 364 63452982
Nicotine dependence 70.44 18.19 23 35653 694 63452652
Lymph node calcification 69.04 18.19 19 35657 313 63453033
Kyphosis 68.96 18.19 32 35644 2508 63450838
Thrombocytopenia 68.81 18.19 4 35672 151153 63302193
Reversible airways obstruction 68.70 18.19 29 35647 1813 63451533
Rhonchi 68.53 18.19 32 35644 2544 63450802
Neutropenia 67.93 18.19 9 35667 174996 63278350
Nasal obstruction 67.06 18.19 28 35648 1703 63451643
Dysphonia 66.77 18.19 106 35570 47508 63405838
Body temperature decreased 64.80 18.19 68 35608 20251 63433095
Respiratory disorder 64.71 18.19 94 35582 38988 63414358
Therapeutic product effect decreased 63.99 18.19 15 35661 193172 63260174
Eosinophil count increased 63.13 18.19 51 35625 10877 63442469
Bronchitis 61.75 18.19 182 35494 124753 63328593
Allergy to animal 61.54 18.19 24 35652 1222 63452124
Pericarditis 61.39 18.19 3 35673 131576 63321770
Forced vital capacity decreased 61.24 18.19 23 35653 1056 63452290
Alopecia 59.70 18.19 61 35615 337475 63115871
Cryopyrin associated periodic syndrome 58.54 18.19 17 35659 343 63453003
Nausea 58.30 18.19 265 35411 854206 62599140
Hypoventilation 57.73 18.19 35 35641 4719 63448627
Secondary immunodeficiency 55.70 18.19 23 35653 1360 63451986
Hypomania 55.58 18.19 38 35638 6292 63447054
Pulmonary mass 55.52 18.19 66 35610 22530 63430816
Mycobacterium avium complex infection 54.41 18.19 29 35647 3059 63450287
White blood cell count decreased 54.35 18.19 7 35669 139097 63314249
Liver function test abnormal 53.93 18.19 97 35579 48084 63405262
Increased bronchial secretion 53.46 18.19 24 35652 1742 63451604
Oropharyngeal pain 51.89 18.19 143 35533 94344 63359002
Hypotension 50.81 18.19 47 35629 272557 63180789
Rheumatoid arthritis 50.66 18.19 41 35635 253778 63199568
Jaundice cholestatic 50.60 18.19 38 35638 7286 63446060
Respiratory rate increased 49.57 18.19 49 35627 13599 63439747
Fibromyalgia 49.52 18.19 127 35549 80293 63373053
Lung neoplasm malignant 49.32 18.19 58 35618 19575 63433771
Urinary tract infection 48.90 18.19 46 35630 264638 63188708
Oropharyngeal discomfort 47.19 18.19 32 35644 5228 63448118
Neurosensory hypoacusis 47.08 18.19 13 35663 217 63453129
Rales 46.88 18.19 46 35630 12651 63440695
Venous pressure jugular increased 46.71 18.19 16 35660 561 63452785
Hypokalaemia 46.47 18.19 3 35673 103801 63349545
Intentional product use issue 46.36 18.19 8 35668 127884 63325462
Abdominal discomfort 46.18 18.19 68 35608 320817 63132529
Scoliosis 45.96 18.19 37 35639 7851 63445495
Nasal mucosal disorder 45.89 18.19 15 35661 454 63452892
Sinusitis 45.51 18.19 249 35427 226404 63226942
Viral infection 45.39 18.19 76 35600 35587 63417759
Blister 45.17 18.19 9 35667 129805 63323541
Blood pressure systolic increased 45.06 18.19 89 35587 47308 63406038
Platelet count decreased 44.98 18.19 6 35670 116116 63337230
Polycystic ovaries 44.46 18.19 29 35647 4442 63448904
Psychotic disorder 44.25 18.19 63 35613 25649 63427697
Disease progression 43.80 18.19 8 35668 122750 63330596
Vocal cord dysfunction 43.36 18.19 15 35661 542 63452804
Impaired healing 42.99 18.19 4 35672 102538 63350808
Schizophrenia 42.35 18.19 39 35637 9913 63443433
Granuloma 42.29 18.19 31 35645 5730 63447616
Respiratory tract inflammation 42.17 18.19 15 35661 589 63452757
Nonspecific reaction 41.73 18.19 22 35654 2270 63451076
Peak expiratory flow rate decreased 41.58 18.19 15 35661 614 63452732
Eczema 41.35 18.19 69 35607 32222 63421124
Dehydration 41.29 18.19 23 35653 173331 63280015
Humidity intolerance 41.25 18.19 13 35663 349 63452997
Affective disorder 40.50 18.19 31 35645 6115 63447231
Sensitivity to weather change 40.17 18.19 33 35643 7204 63446142
Blood cholesterol increased 39.96 18.19 130 35546 93902 63359444
Eosinophilic pneumonia chronic 39.64 18.19 11 35665 187 63453159
CFTR gene mutation 39.58 18.19 10 35666 116 63453230
Muscle tension dysphonia 38.80 18.19 11 35665 203 63453143
Airway remodelling 38.41 18.19 9 35667 74 63453272
Febrile neutropenia 37.65 18.19 10 35666 118439 63334907
Pancytopenia 37.56 18.19 5 35671 96928 63356418
Atelectasis 37.51 18.19 53 35623 21430 63431916
Limb injury 37.49 18.19 58 35618 25419 63427927
Malaise 37.25 18.19 377 35299 415577 63037769
Psoriatic arthropathy 37.24 18.19 4 35672 91516 63361830
Seizure 37.17 18.19 14 35662 132620 63320726
Skin lesion 37.15 18.19 64 35612 30657 63422689
Anti-cyclic citrullinated peptide antibody positive 36.58 18.19 10 35666 116202 63337144
Decreased appetite 36.30 18.19 53 35623 250999 63202347
Discomfort 35.99 18.19 25 35651 167349 63285997
Dyslipidaemia 35.47 18.19 31 35645 7362 63445984
Blood creatinine increased 35.34 18.19 4 35672 87840 63365506
Malignant neoplasm progression 34.97 18.19 3 35673 82118 63371228
Vomiting 34.86 18.19 179 35497 559438 62893908
FEV1/FVC ratio decreased 34.82 18.19 9 35667 115 63453231
Chest X-ray abnormal 34.57 18.19 25 35651 4524 63448822
Pulmonary function test abnormal 34.56 18.19 18 35658 1812 63451534
Gastrointestinal haemorrhage 34.48 18.19 3 35673 81173 63372173
Eosinophilic granulomatosis with polyangiitis 34.22 18.19 19 35657 2173 63451173
Respiratory tract infection 33.68 18.19 73 35603 41410 63411936
Lipohypertrophy 33.52 18.19 13 35663 652 63452694
Abscess 33.46 18.19 44 35632 16624 63436722
Sepsis 32.75 18.19 23 35653 153100 63300246
Breast neoplasm 32.65 18.19 16 35660 1416 63451930
Rib fracture 32.63 18.19 51 35625 22546 63430800
Haemoglobin decreased 32.26 18.19 21 35655 145464 63307882
Sinus disorder 32.15 18.19 53 35623 24500 63428846
Emphysema 32.04 18.19 35 35641 10903 63442443
Aspartate aminotransferase increased 31.95 18.19 6 35670 90271 63363075
Asthmatic crisis 31.87 18.19 17 35659 1796 63451550
Peak expiratory flow rate abnormal 31.34 18.19 8 35668 97 63453249
Hyponatraemia 31.04 18.19 12 35664 111888 63341458
Lung disorder 31.02 18.19 91 35585 62170 63391176
Granulomatosis with polyangiitis 30.96 18.19 18 35658 2247 63451099
Frustration tolerance decreased 30.94 18.19 28 35648 6960 63446386
Rectal prolapse 30.44 18.19 17 35659 1966 63451380
Neuropathy peripheral 30.21 18.19 13 35663 113654 63339692
Angioplasty 30.09 18.19 15 35661 1377 63451969
Hepatic enzyme increased 29.94 18.19 42 35634 202286 63251060
Crystal arthropathy 29.89 18.19 10 35666 326 63453020
Ankle fracture 29.63 18.19 43 35633 17812 63435534
Maternal exposure during pregnancy 29.38 18.19 49 35627 220013 63233333
Alanine aminotransferase increased 29.00 18.19 11 35665 103759 63349587
Renal impairment 28.96 18.19 7 35669 88348 63364998
Exposure during pregnancy 28.74 18.19 27 35649 155520 63297826
Croup infectious 28.66 18.19 11 35665 536 63452810
Leukopenia 28.57 18.19 102 35574 77188 63376158
Lower respiratory tract infection 28.32 18.19 148 35528 132159 63321187
Psoriasis 28.29 18.19 7 35669 86950 63366396
Pulmonary congestion 27.53 18.19 41 35635 17377 63435969
Constipation 27.41 18.19 53 35623 224890 63228456
Seasonal allergy 27.13 18.19 45 35631 20905 63432441
Respiration abnormal 27.02 18.19 25 35651 6392 63446954
Pain 26.28 18.19 278 35398 740350 62712996
Exposure to allergen 26.13 18.19 9 35667 321 63453025
Chronic sinusitis 25.93 18.19 34 35642 12809 63440537
Ligament pain 25.52 18.19 8 35668 211 63453135
Forced expiratory volume 25.50 18.19 5 35671 15 63453331
Weight decreased 25.27 18.19 252 35424 276546 63176800
Sinus congestion 24.92 18.19 40 35636 18083 63435263
Fear of disease 24.84 18.19 13 35663 1321 63452025
Tenderness 24.68 18.19 45 35631 22533 63430813
Eosinophil count abnormal 24.43 18.19 10 35666 578 63452768
Sinus pain 24.24 18.19 18 35658 3392 63449954
Lung diffusion disorder 23.79 18.19 6 35670 69 63453277
Rhinorrhoea 23.77 18.19 86 35590 65491 63387855
Stress 23.43 18.19 87 35589 67080 63386266
Drug abuse 23.27 18.19 6 35670 72512 63380834
Deep vein thrombosis 23.22 18.19 9 35667 83791 63369555
Nocturnal dyspnoea 23 18.19 12 35664 1212 63452134
Choking 22.87 18.19 28 35648 9851 63443495
Soft tissue swelling 22.82 18.19 12 35664 1232 63452114
Lung diffusion test decreased 22.78 18.19 10 35666 688 63452658
Swelling 22.71 18.19 79 35597 275299 63178047
Cholelithiasis 22.64 18.19 65 35611 43860 63409486
Impaired quality of life 22.59 18.19 33 35643 13750 63439596
Paranasal sinus inflammation 22.57 18.19 9 35667 486 63452860
Infection 22.56 18.19 212 35464 228961 63224385
Aphonia 22.45 18.19 28 35648 10035 63443311
Sinus tachycardia 22.38 18.19 45 35631 24223 63429123
Lower respiratory tract congestion 22.25 18.19 16 35660 2870 63450476
Depressed level of consciousness 22.23 18.19 4 35672 62074 63391272
Forearm fracture 22.11 18.19 9 35667 513 63452833
Musculoskeletal stiffness 22.05 18.19 44 35632 184574 63268772
Oedema 21.76 18.19 14 35662 97608 63355738
Intentional product misuse 21.66 18.19 4 35672 60913 63392433
Eosinophilic bronchitis 21.30 18.19 9 35667 564 63452782
Therapy non-responder 21.28 18.19 8 35668 75893 63377453
Allergic sinusitis 21.08 18.19 11 35665 1111 63452235
Adverse event 20.91 18.19 6 35670 67553 63385793
Fibromuscular dysplasia 20.72 18.19 7 35669 235 63453111
Osteoporosis 20.61 18.19 75 35601 57263 63396083
Pancreatitis relapsing 20.25 18.19 10 35666 900 63452446
Blood glucose increased 20.09 18.19 11 35665 83745 63369601
Lip pruritus 19.87 18.19 10 35666 937 63452409
Respiratory failure 19.62 18.19 17 35659 101841 63351505
Smoke sensitivity 19.62 18.19 8 35668 458 63452888
Lung hyperinflation 19.60 18.19 11 35665 1284 63452062
Multiple organ dysfunction syndrome 19.60 18.19 4 35672 56748 63396598
Pleural rub 19.48 18.19 5 35671 62 63453284
Cognitive disorder 19.14 18.19 4 35672 55811 63397535
Fluid retention 19.03 18.19 5 35671 59681 63393665
Overdose 18.97 18.19 22 35654 115056 63338290
Total lung capacity decreased 18.92 18.19 13 35663 2170 63451176
Oesophagogastroduodenoscopy 18.90 18.19 6 35670 165 63453181
Animal scratch 18.67 18.19 11 35665 1407 63451939
Laryngeal stenosis 18.65 18.19 10 35666 1068 63452278
Suicidal ideation 18.49 18.19 6 35670 62415 63390931
Myalgia 18.33 18.19 143 35533 146386 63306960
Blood immunoglobulin E decreased 18.30 18.19 5 35671 80 63453266
Forced expiratory volume abnormal 18.25 18.19 5 35671 81 63453265

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 1981.80 26.01 744 15668 41912 34898607
Wheezing 1140.42 26.01 497 15915 40905 34899614
Therapeutic product effect incomplete 806.78 26.01 417 15995 50124 34890395
Obstructive airways disorder 781.13 26.01 288 16124 15206 34925313
Full blood count abnormal 666.34 26.01 270 16142 18398 34922121
Sleep disorder due to a general medical condition 532.80 26.01 165 16247 5056 34935463
Bronchiectasis 420.28 26.01 162 16250 9639 34930880
Loss of personal independence in daily activities 366.13 26.01 215 16197 32964 34907555
Productive cough 350.24 26.01 219 16193 37594 34902925
Pulmonary function test decreased 304.89 26.01 107 16305 4868 34935651
Sputum discoloured 281.82 26.01 114 16298 7698 34932821
Dyspnoea 265.61 26.01 559 15853 376223 34564296
Cough 256.65 26.01 333 16079 149807 34790712
Asthma-chronic obstructive pulmonary disease overlap syndrome 253.93 26.01 68 16344 1219 34939300
Breath sounds abnormal 233.10 26.01 96 16316 6785 34933734
Nasal congestion 232.28 26.01 141 16271 22916 34917603
Chest discomfort 207.26 26.01 185 16227 54345 34886174
Respiratory disorder 186.81 26.01 115 16297 19149 34921370
Nasal obstruction 183.02 26.01 46 16366 634 34939885
Forced expiratory volume decreased 181.44 26.01 65 16347 3138 34937381
Dust allergy 174.63 26.01 47 16365 859 34939660
Sinus pain 170.20 26.01 44 16368 683 34939836
Nasal polyps 161.65 26.01 56 16356 2447 34938072
Eosinophil count abnormal 156.63 26.01 35 16377 279 34940240
Bronchial hyperreactivity 153.36 26.01 49 16363 1660 34938859
Congenital hiatus hernia 149.66 26.01 41 16371 803 34939716
Mite allergy 147.54 26.01 39 16373 663 34939856
Spirometry abnormal 141.62 26.01 38 16374 686 34939833
Conjunctivitis allergic 140.75 26.01 42 16370 1128 34939391
Eosinophil count increased 139.83 26.01 72 16340 8500 34932019
Mycotic allergy 138.46 26.01 36 16376 572 34939947
Dyspnoea exertional 119.12 26.01 123 16289 43156 34897363
Mycobacterium avium complex infection 116.50 26.01 44 16368 2467 34938052
Blood immunoglobulin E increased 108.74 26.01 42 16370 2504 34938015
Adrenal suppression 108.11 26.01 30 16382 617 34939902
Acute kidney injury 107.12 26.01 10 16402 304978 34635541
Influenza 101.85 26.01 121 16291 49545 34890974
Seasonal allergy 100.10 26.01 53 16359 6622 34933897
Lung consolidation 97.21 26.01 50 16362 5886 34934633
Pulmonary function test abnormal 93.77 26.01 38 16374 2572 34937947
Eye disorder 85.05 26.01 54 16358 9474 34931045
Rhinorrhoea 83.62 26.01 80 16332 25588 34914931
Gingival disorder 83.54 26.01 30 16382 1457 34939062
Vital capacity decreased 83.44 26.01 22 16390 370 34940149
Osteopenia 82.76 26.01 42 16370 4807 34935712
Sinusitis 80.17 26.01 98 16314 41304 34899215
Emphysema 80.12 26.01 52 16360 9473 34931046
Throat irritation 79.87 26.01 54 16358 10531 34929988
Airway remodelling 78.63 26.01 19 16393 220 34940299
Lower respiratory tract infection 78.28 26.01 85 16327 31552 34908967
Chronic sinusitis 77.84 26.01 32 16380 2247 34938272
Malignant melanoma in situ 75.55 26.01 29 16383 1699 34938820
Hypoxia 75.31 26.01 110 16302 54985 34885534
Toxicity to various agents 74.64 26.01 5 16407 200357 34740162
Chronic obstructive pulmonary disease 73.23 26.01 102 16310 48816 34891703
Upper-airway cough syndrome 73.18 26.01 35 16377 3523 34936996
Pulmonary mass 70.60 26.01 54 16358 12758 34927761
Eosinophil count 70.27 26.01 16 16396 140 34940379
Vocal cord dysfunction 67.81 26.01 16 16396 166 34940353
Gastrooesophageal reflux disease 67.39 26.01 86 16326 37838 34902681
Death 66.38 26.01 54 16358 397995 34542524
Nodule 64.25 26.01 40 16372 6779 34933740
Eczema 62.97 26.01 59 16353 18377 34922142
Oral disorder 58.83 26.01 32 16380 4217 34936302
Skin irritation 58.40 26.01 35 16377 5542 34934977
Decreased activity 57.87 26.01 32 16380 4355 34936164
Suffocation feeling 57.24 26.01 18 16394 578 34939941
Drug interaction 56.39 26.01 18 16394 225928 34714591
Eosinophilic granulomatosis with polyangiitis 54.89 26.01 24 16388 1963 34938556
Normochromic normocytic anaemia 53.09 26.01 30 16382 4257 34936262
Thrombocytopenia 52.47 26.01 6 16406 156241 34784278
Middle insomnia 52.02 26.01 35 16377 6767 34933752
Pleural thickening 51.47 26.01 15 16397 370 34940149
Inspiratory capacity abnormal 51.26 26.01 12 16400 120 34940399
Diaphragmatic disorder 50.79 26.01 20 16392 1255 34939264
Arteriosclerosis coronary artery 50.60 26.01 44 16368 12441 34928078
Diarrhoea 50.15 26.01 66 16346 389846 34550673
Sensitivity to weather change 49.38 26.01 21 16391 1605 34938914
Atopy 48.22 26.01 13 16399 239 34940280
Neutropenia 47.98 26.01 8 16404 156770 34783749
Oesophageal polyp 47.50 26.01 10 16402 58 34940461
Respiratory symptom 47.36 26.01 21 16391 1776 34938743
Bronchial obstruction 46.21 26.01 20 16392 1596 34938923
Bronchitis 45.06 26.01 75 16337 41888 34898631
Sneezing 45.02 26.01 29 16383 5213 34935306
Sputum increased 44.78 26.01 22 16390 2348 34938171
Glaucoma 44.51 26.01 32 16380 6880 34933639
Platelet count decreased 44.50 26.01 3 16409 119714 34820805
Ocular discomfort 43.91 26.01 21 16391 2113 34938406
Anaemia 43.56 26.01 28 16384 233307 34707212
Respiratory tract congestion 43.18 26.01 30 16382 6109 34934410
Benign prostatic hyperplasia 43.12 26.01 43 16369 14452 34926067
Bronchial wall thickening 42.65 26.01 18 16394 1350 34939169
Pneumonitis 42.48 26.01 65 16347 33813 34906706
Eosinophilia 41.20 26.01 56 16356 26166 34914353
Asthenia 41.11 26.01 33 16379 245218 34695301
Nasopharyngitis 41.01 26.01 97 16315 69871 34870648
Adrenal insufficiency 40.55 26.01 41 16371 14006 34926513
Infective exacerbation of chronic obstructive airways disease 40.49 26.01 19 16393 1832 34938687
Rhinitis 40.03 26.01 29 16383 6309 34934210
Micturition urgency 39.27 26.01 29 16383 6496 34934023
Joint injury 38.53 26.01 33 16379 9140 34931379
Respiratory rate increased 38.35 26.01 34 16378 9860 34930659
Illness 38.16 26.01 39 16373 13490 34927029
Panic reaction 38.11 26.01 17 16395 1458 34939061
Restrictive pulmonary disease 38.06 26.01 16 16396 1188 34939331
Eye swelling 36.08 26.01 33 16379 9962 34930557
Peak expiratory flow rate decreased 35.41 26.01 9 16403 130 34940389
Kidney infection 34.79 26.01 25 16387 5369 34935150
Constipation 33.97 26.01 11 16401 136971 34803548
Vascular shunt 33.64 26.01 7 16405 38 34940481
Blood test abnormal 33.27 26.01 27 16385 6944 34933575
Central nervous system mass 33.15 26.01 9 16403 170 34940349
Wall motion score index abnormal 33.00 26.01 9 16403 173 34940346
Hypercholesterolaemia 31.77 26.01 29 16383 8733 34931786
Eye pruritus 31.57 26.01 27 16385 7462 34933057
Sepsis 31.03 26.01 20 16392 166541 34773978
Malignant neoplasm progression 30.51 26.01 3 16409 88043 34852476
Disease progression 29.93 26.01 7 16405 108070 34832449
Haemoglobin decreased 29.42 26.01 10 16402 120762 34819757
Stridor 29.41 26.01 17 16395 2517 34938002
Upper respiratory tract congestion 29.31 26.01 12 16400 833 34939686
Nausea 28.94 26.01 74 16338 339834 34600685
White blood cell count decreased 28.89 26.01 5 16407 95440 34845079
Pancytopenia 28.77 26.01 5 16407 95152 34845367
Blood creatinine increased 28.70 26.01 5 16407 94971 34845548
Oropharyngeal pain 28.60 26.01 56 16356 35429 34905090
Systolic dysfunction 28.36 26.01 17 16395 2691 34937828
Cardiac septal defect 28.02 26.01 9 16403 310 34940209
Dehydration 27.99 26.01 13 16399 129956 34810563
Confusional state 27.27 26.01 17 16395 144143 34796376
Hypoventilation 27.15 26.01 18 16394 3396 34937123
Hypohidrosis 26.90 26.01 8 16404 212 34940307
Vomiting 26.84 26.01 47 16365 247574 34692945
Renal failure 26.69 26.01 14 16398 130543 34809976
Lip swelling 26.26 26.01 35 16377 16045 34924474
Myocardial infarction 26.24 26.01 12 16400 121073 34819446

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 3740.60 19.06 1730 44285 133365 79565008
Wheezing 2245.62 19.06 1168 44847 115496 79582877
Obstructive airways disorder 1666.04 19.06 641 45374 30818 79667555
Full blood count abnormal 1036.27 19.06 493 45522 39981 79658392
Therapeutic product effect incomplete 1008.01 19.06 754 45261 140891 79557482
Sleep disorder due to a general medical condition 897.17 19.06 330 45685 13947 79684426
Productive cough 781.06 19.06 537 45478 87794 79610579
Cough 704.74 19.06 957 45058 365832 79332541
Sputum discoloured 656.23 19.06 297 45718 21446 79676927
Dyspnoea 649.87 19.06 1482 44533 855543 78842830
Forced expiratory volume decreased 525.67 19.06 190 45825 7624 79690749
Chest discomfort 481.67 19.06 490 45525 137554 79560819
Loss of personal independence in daily activities 463.59 19.06 420 45595 102160 79596213
Bronchiectasis 394.53 19.06 212 45803 22174 79676199
Breath sounds abnormal 358.42 19.06 178 45837 15806 79682567
Asthma-chronic obstructive pulmonary disease overlap syndrome 357.26 19.06 114 45901 3107 79695266
Middle insomnia 334.04 19.06 170 45845 15899 79682474
Nasal congestion 315.75 19.06 298 45717 76254 79622119
Pulmonary function test decreased 314.55 19.06 130 45885 7507 79690866
Nasal polyps 272.54 19.06 116 45899 7211 79691162
Dyspnoea exertional 226.40 19.06 265 45750 86808 79611565
Acute kidney injury 210.97 19.06 26 45989 519378 79178995
Blood immunoglobulin E increased 205.20 19.06 89 45926 5793 79692580
Toxicity to various agents 195.72 19.06 12 46003 421528 79276845
Gastrooesophageal reflux disease 188.56 19.06 265 45750 103981 79594392
Chronic obstructive pulmonary disease 183.27 19.06 236 45779 85183 79613190
Influenza 179.67 19.06 291 45724 129315 79569058
Pneumonia viral 176.21 19.06 92 45923 9066 79689307
Nasal obstruction 173.62 19.06 60 45955 2104 79696269
Bronchial wall thickening 161.94 19.06 60 45955 2581 79695792
Bronchial secretion retention 159.37 19.06 67 45948 4037 79694336
Rhinitis 157.10 19.06 101 45914 14706 79683667
Restrictive pulmonary disease 155.62 19.06 58 45957 2537 79695836
Total lung capacity increased 154.98 19.06 56 45959 2242 79696131
Bacterial disease carrier 152.23 19.06 50 45965 1496 79696877
Respiratory disorder 150.28 19.06 156 45859 44700 79653673
Upper-airway cough syndrome 149.98 19.06 90 45925 11603 79686770
Nasopharyngitis 148.98 19.06 400 45615 253481 79444892
Drug interaction 145.66 19.06 31 45984 415152 79283221
Illness 145.58 19.06 156 45859 46355 79652018
Spirometry abnormal 144.75 19.06 43 45972 916 79697457
Dust allergy 144.52 19.06 48 45967 1488 79696885
Eosinophil count increased 143.85 19.06 101 45914 17004 79681369
Death 139.25 19.06 77 45938 566437 79131936
Blood test abnormal 138.40 19.06 100 45915 17610 79680763
Congenital hiatus hernia 137.79 19.06 40 45975 784 79697589
Eosinophilia 136.52 19.06 149 45866 45196 79653177
Bronchial hyperreactivity 136.28 19.06 55 45960 2985 79695388
Rhinitis allergic 135.90 19.06 86 45929 12183 79686190
Diarrhoea 135.29 19.06 187 45828 880302 78818071
Lung diffusion test abnormal 131.84 19.06 33 45982 357 79698016
Mite allergy 130.11 19.06 42 45973 1188 79697185
Respiratory tract congestion 129.93 19.06 101 45914 19853 79678520
Conjunctivitis allergic 127.65 19.06 45 45970 1675 79696698
Glaucoma 126.45 19.06 99 45916 19662 79678711
Seasonal allergy 124.48 19.06 91 45924 16315 79682058
Heart rate increased 119.49 19.06 234 45781 120490 79577883
Sinus pain 118.82 19.06 53 45962 3689 79694684
Thrombocytopenia 116.00 19.06 10 46005 265249 79433124
Neutropenia 115.21 19.06 15 46000 287695 79410678
Bronchitis 111.29 19.06 238 45777 130406 79567967
Eosinophil count abnormal 110.43 19.06 33 45982 718 79697655
Soft tissue disorder 109.10 19.06 49 45966 3466 79694907
Mycotic allergy 106.13 19.06 38 45977 1481 79696892
Bronchial neoplasm 104.54 19.06 29 45986 479 79697894
Pulmonary function test abnormal 104.43 19.06 50 45965 4094 79694279
Nasal turbinate hypertrophy 103.32 19.06 31 45984 684 79697689
Sarcoidosis 101.35 19.06 62 45953 8273 79690100
Airway remodelling 100.00 19.06 25 45990 269 79698104
Sleep apnoea syndrome 99.73 19.06 114 45901 36364 79662009
Sinusitis 98.87 19.06 292 45723 195209 79503164
Crepitations 95.70 19.06 64 45951 9953 79688420
Secretion discharge 95.55 19.06 75 45940 14947 79683426
Vocal cord dysfunction 94.67 19.06 28 45987 587 79697786
Confusional state 94.12 19.06 33 45982 317964 79380409
Lower respiratory tract infection 93.92 19.06 221 45794 128999 79569374
Hyper IgE syndrome 92.30 19.06 27 45988 544 79697829
Infusion related reaction 92.16 19.06 12 46003 230225 79468148
Bronchospasm 91.53 19.06 91 45924 24768 79673605
Bronchial disorder 91.21 19.06 39 45976 2450 79695923
Blood pressure increased 88.74 19.06 296 45719 211064 79487309
Endometrial ablation 88.40 19.06 29 45986 864 79697509
Platelet count decreased 86.02 19.06 7 46008 194657 79503716
Eosinophilic granulomatosis with polyangiitis 85.71 19.06 42 45973 3618 79694755
Respiratory rate increased 85.00 19.06 82 45933 21518 79676855
Rhonchi 84.73 19.06 43 45972 3993 79694380
Pneumonia 83.94 19.06 659 45356 659587 79038786
Hypoventilation 83.43 19.06 52 45963 7172 79691201
Dysphonia 83.26 19.06 131 45884 56741 79641632
Rhinorrhoea 82.06 19.06 153 45862 75921 79622452
Bronchial haemorrhage 80.97 19.06 30 45985 1290 79697083
Sputum purulent 80.34 19.06 30 45985 1319 79697054
Off label use 80.20 19.06 263 45752 906952 78791421
White blood cell count decreased 79.89 19.06 8 46007 188280 79510093
Throat clearing 79.21 19.06 36 45979 2618 79695755
Body temperature decreased 78.79 19.06 95 45920 32050 79666323
Idiopathic intracranial hypertension 78.54 19.06 38 45977 3184 79695189
Sensitivity to weather change 78.29 19.06 52 45963 7995 79690378
Emphysema 77.95 19.06 69 45946 16231 79682142
Sinus operation 77.73 19.06 35 45980 2490 79695883
Superinfection 76.87 19.06 43 45972 4859 79693514
Chronic sinusitis 76.37 19.06 62 45953 12964 79685409
Hypotension 75.22 19.06 86 45929 440231 79258142
Broncholithiasis 74.49 19.06 19 45996 223 79698150
Drug abuse 74.30 19.06 5 46010 162686 79535687
Rash 72.52 19.06 140 45875 578218 79120155
Overdose 70.44 19.06 11 46004 184195 79514178
Cardiac murmur 69.79 19.06 64 45951 15760 79682613
Dehydration 69.66 19.06 28 45987 248159 79450214
Disease progression 68.29 19.06 12 46003 184350 79514023
Arthritis 67.24 19.06 181 45834 114699 79583674
Peak expiratory flow rate decreased 66.89 19.06 22 45993 661 79697712
Mycobacterium avium complex infection 65.80 19.06 38 45977 4562 79693811
Rib deformity 65.34 19.06 17 45998 217 79698156
Febrile neutropenia 64.92 19.06 26 45989 230973 79467400
Lymph node calcification 64.35 19.06 19 45996 396 79697977
Lung consolidation 64.21 19.06 48 45967 8899 79689474
Kyphosis 63.37 19.06 31 45984 2660 79695713
Ventricular failure 63.37 19.06 20 45995 525 79697848
Eosinophil count 63.23 19.06 15 46000 127 79698246
Pancytopenia 63.14 19.06 10 46005 165735 79532638
Neuropathy peripheral 62.64 19.06 5 46010 141300 79557073
Nausea 62.19 19.06 313 45702 956883 78741490
Pulmonary mass 61.87 19.06 80 45935 28954 79669419
Sepsis 61.31 19.06 40 45975 269388 79428985
Aspartate aminotransferase increased 61.20 19.06 5 46010 138636 79559737
Allergy to animal 60.96 19.06 25 45990 1414 79696959
Gastrointestinal haemorrhage 60.81 19.06 7 46008 147712 79550661
Viral infection 60.09 19.06 97 45918 42919 79655454
Increased bronchial secretion 59.96 19.06 32 45983 3295 79695078
Blood creatinine increased 59.87 19.06 9 46006 155048 79543325
Malignant neoplasm progression 59.76 19.06 5 46010 135985 79562388
Forced vital capacity decreased 59.57 19.06 26 45989 1717 79696656
Alanine aminotransferase increased 59.31 19.06 11 46004 162559 79535814
Malaise 58.87 19.06 483 45532 489386 79208987
Hypokalaemia 58.86 19.06 7 46008 144033 79554340
Intentional product use issue 58.34 19.06 9 46006 152103 79546270
Haemoglobin decreased 57.69 19.06 28 45987 222091 79476282
Reversible airways obstruction 57.10 19.06 27 45988 2149 79696224
Malignant melanoma in situ 57.01 19.06 28 45987 2424 79695949
Oropharyngeal pain 56.82 19.06 165 45850 109188 79589185
Arthropathy 56.61 19.06 16 45999 177095 79521278
Cryopyrin associated periodic syndrome 56.37 19.06 17 45998 382 79697991
Nicotine dependence 56.01 19.06 21 45994 934 79697439
Herpes zoster 55.82 19.06 148 45867 92935 79605438
Eczema 55.60 19.06 91 45924 40727 79657646
Hyponatraemia 55.14 19.06 17 45998 177831 79520542
Bronchial obstruction 53.80 19.06 28 45987 2740 79695633
Blood pressure systolic increased 53.54 19.06 119 45896 66867 79631506
Therapeutic product effect decreased 52.01 19.06 15 46000 163848 79534525
Eosinophilic pneumonia chronic 52.00 19.06 17 45998 501 79697872
Respiratory symptom 51.60 19.06 33 45982 4758 79693615
Vomiting 51.42 19.06 204 45811 665624 79032749
Sinus disorder 51.19 19.06 64 45951 22400 79675973
Contraindicated product administered 50.78 19.06 14 46001 157524 79540849
Rales 50.47 19.06 60 45955 19941 79678432
Treatment failure 49.87 19.06 18 45997 170468 79527905
Cardiac arrest 48.95 19.06 19 45996 172077 79526296
Seizure 48.73 19.06 24 45991 188810 79509563
Hypomania 48.70 19.06 38 45977 7506 79690867
Nasal mucosal disorder 48.60 19.06 15 46000 365 79698008
Polycystic ovaries 48.23 19.06 29 45986 3750 79694623
Hand deformity 48.01 19.06 3 46012 103916 79594457
Scoliosis 46.89 19.06 37 45978 7427 79690946
Renal impairment 45.58 19.06 17 45998 157766 79540607
Eye disorder 44.49 19.06 61 45954 23351 79675022
Inspiratory capacity abnormal 44.46 19.06 11 46004 113 79698260
Constipation 44.37 19.06 59 45956 282991 79415382
Diaphragmatic disorder 43.74 19.06 21 45994 1729 79696644
Respiratory tract inflammation 43.42 19.06 17 45998 851 79697522
Atopy 42.40 19.06 14 46001 426 79697947
Neurosensory hypoacusis 42.19 19.06 12 46003 218 79698155
Decreased activity 41.96 19.06 37 45978 8657 79689716
Weight decreased 41.94 19.06 349 45666 354849 79343524
Benign prostatic hyperplasia 41.81 19.06 42 45973 11570 79686803
Depressed level of consciousness 41.26 19.06 4 46011 96648 79601725
Urinary tract infection 41.24 19.06 59 45956 274453 79423920
Suffocation feeling 41.06 19.06 20 45995 1700 79696673
Asthmatic crisis 41.03 19.06 21 45994 1985 79696388
Rheumatoid arthritis 40.94 19.06 36 45979 208434 79489939
Deep vein thrombosis 40.39 19.06 10 46005 120909 79577464
Atelectasis 40.05 19.06 69 45946 32188 79666185
Sneezing 40.02 19.06 53 45962 19630 79678743
Glossodynia 39.88 19.06 6 46009 103331 79595042
Anaemia 39.85 19.06 128 45887 444887 79253486
Blister 39.67 19.06 10 46005 119466 79578907
Humidity intolerance 39.42 19.06 13 46002 394 79697979
Nonspecific reaction 39.13 19.06 22 45993 2510 79695863
Respiratory tract infection 38.34 19.06 86 45929 48603 79649770
Oesophageal polyp 38.28 19.06 9 46006 73 79698300
Multiple organ dysfunction syndrome 38.16 19.06 11 46004 120235 79578138
Pneumonitis 37.73 19.06 98 45917 60762 79637611
Throat irritation 37.63 19.06 77 45938 40869 79657504
Neutrophil count decreased 37.33 19.06 5 46010 93954 79604419
Eosinophilic bronchitis 37.00 19.06 13 46002 479 79697894
Lower respiratory tract congestion 36.89 19.06 25 45990 3972 79694401
Sputum increased 35.92 19.06 26 45989 4587 79693786
Septic shock 35.85 19.06 13 46002 122788 79575585
Oropharyngeal discomfort 35.59 19.06 31 45984 7135 79691238
Jaundice cholestatic 35.56 19.06 38 45977 11246 79687127
CFTR gene mutation 35.33 19.06 9 46006 105 79698268
Hyperkalaemia 35.33 19.06 11 46004 114387 79583986
Bradycardia 35.31 19.06 17 45998 135540 79562833
Cardiac failure 35.18 19.06 23 45992 154819 79543554
Limb injury 35.14 19.06 62 45953 29466 79668907
Sinus congestion 35.07 19.06 50 45965 19846 79678527
Pulmonary congestion 35.00 19.06 59 45956 27041 79671332
Decreased appetite 34.62 19.06 93 45922 342325 79356048
Infective exacerbation of chronic obstructive airways disease 34.59 19.06 21 45994 2763 79695610
Weight increased 34.59 19.06 276 45739 277110 79421263
Vital capacity decreased 34.24 19.06 18 45997 1798 79696575
Normochromic normocytic anaemia 33.58 19.06 31 45984 7696 79690677
Intentional product misuse 33.52 19.06 7 46008 95158 79603215
Affective disorder 33.51 19.06 32 45983 8287 79690086
Venous pressure jugular increased 33.25 19.06 16 45999 1324 79697049
Arteriosclerosis coronary artery 33.22 19.06 46 45969 17770 79680603
Asthenia 32.70 19.06 168 45847 511521 79186852
Lung neoplasm malignant 32.62 19.06 58 45957 27734 79670639
Renal failure 32.40 19.06 41 45974 200927 79497446
Osteoporosis 32.39 19.06 86 45929 54026 79644347
Impaired healing 31.81 19.06 6 46009 87649 79610724
Secondary immunodeficiency 31.70 19.06 21 45994 3213 79695160
Granuloma 31.70 19.06 31 45984 8266 79690107
Muscle tension dysphonia 31.56 19.06 9 46006 165 79698208
Wall motion score index abnormal 31.16 19.06 9 46006 173 79698200
Stress 31.16 19.06 109 45906 79503 79618870
Central nervous system mass 31.12 19.06 9 46006 174 79698199
Hypersensitivity 31.10 19.06 258 45757 261981 79436392
Abdominal discomfort 31.07 19.06 61 45954 250666 79447707
Coma 30.51 19.06 10 46005 100639 79597734
Frustration tolerance decreased 30.49 19.06 29 45986 7473 79690900
Ascites 30.06 19.06 4 46011 75558 79622815
Rib fracture 29.86 19.06 56 45959 27891 79670482
Cognitive disorder 29.57 19.06 3 46012 69923 79628450
Eye pruritus 29.56 19.06 47 45968 20523 79677850
Vascular shunt 29.54 19.06 7 46008 59 79698314
Exposure to allergen 29.48 19.06 10 46005 331 79698042
Helicobacter infection 29.45 19.06 3 46012 69701 79628672
Chest X-ray abnormal 29.28 19.06 29 45986 7854 79690519
FEV1/FVC ratio decreased 29.01 19.06 9 46006 223 79698150
Transient ischaemic attack 28.80 19.06 81 45934 52614 79645759
Fibromyalgia 28.65 19.06 92 45923 64248 79634125
Rectal prolapse 28.54 19.06 17 45998 2161 79696212
International normalised ratio increased 28.30 19.06 7 46008 84714 79613659
Angioplasty 28.28 19.06 16 45999 1847 79696526
Respiration abnormal 27.73 19.06 28 45987 7760 79690613
Nocturnal dyspnoea 27.52 19.06 15 46000 1611 79696762
Ankle fracture 27.52 19.06 41 45974 16928 79681445
Pleural effusion 27.42 19.06 26 45989 145236 79553137
Alopecia 27.21 19.06 58 45957 231297 79467076
Oral pain 27.12 19.06 58 45957 31740 79666633
Rhabdomyolysis 26.76 19.06 13 46002 103118 79595255
Agitation 26.75 19.06 12 46003 99703 79598670
Hepatic function abnormal 26.54 19.06 5 46010 73102 79625271
Lipohypertrophy 26.41 19.06 12 46003 872 79697501
Total lung capacity decreased 26.41 19.06 18 45997 2887 79695486
Lung disorder 26.27 19.06 104 45911 80453 79617920
Peak expiratory flow rate abnormal 26.24 19.06 7 46008 99 79698274
Schizophrenia 26.04 19.06 38 45977 15402 79682971
Breast neoplasm 25.80 19.06 12 46003 920 79697453
Ocular discomfort 25.65 19.06 22 45993 4961 79693412
Cardiac septal defect 25.58 19.06 9 46006 333 79698040
Hypercholesterolaemia 25.58 19.06 47 45968 23048 79675325
Skin lesion 25.55 19.06 67 45948 41777 79656596
Loss of consciousness 25.30 19.06 36 45979 167907 79530466
Psoriasis 25.29 19.06 10 46005 89577 79608796
Psoriatic arthropathy 25.00 19.06 7 46008 77992 79620381
Psychotic disorder 24.98 19.06 66 45949 41336 79657037
Croup infectious 24.94 19.06 11 46004 745 79697628
Hepatic failure 24.94 19.06 3 46012 61209 79637164
Therapy non-responder 24.93 19.06 11 46004 92294 79606079
Fear of disease 24.91 19.06 13 46002 1279 79697094
Infection 24.61 19.06 230 45785 241482 79456891
Nodule 24.47 19.06 46 45969 22948 79675425
Granulomatosis with polyangiitis 24.25 19.06 17 45998 2853 79695520
Oral candidiasis 24.08 19.06 53 45962 29575 79668798
Ligament pain 24.02 19.06 8 46007 250 79698123
Blood alkaline phosphatase increased 23.88 19.06 4 46011 63660 79634713
Choking 23.70 19.06 32 45983 12069 79686304
Allergic sinusitis 23.50 19.06 11 46004 856 79697517
Irritable bowel syndrome 23.15 19.06 4 46011 62237 79636136
Obstruction 23.01 19.06 20 45995 4590 79693783
Respiratory arrest 23.01 19.06 3 46012 57547 79640826
Drug-induced liver injury 23.00 19.06 5 46010 66112 79632261
Lung opacity 22.96 19.06 21 45994 5153 79693220
Hypohidrosis 22.92 19.06 8 46007 289 79698084
Osteopenia 22.42 19.06 39 45976 18325 79680048
Medication error 22.30 19.06 6 46009 68636 79629737
Respiratory failure 21.56 19.06 45 45970 180866 79517507
Pneumonia aspiration 21.48 19.06 6 46009 66961 79631412
Forearm fracture 21.42 19.06 9 46006 541 79697832
Somnolence 21.17 19.06 69 45946 238912 79459461
Electrocardiogram QT prolonged 21.11 19.06 13 46002 90373 79608000
Fluid retention 21.04 19.06 7 46008 69802 79628571
Suicidal ideation 20.77 19.06 9 46006 76331 79622042
Eosinophilic pneumonia 20.59 19.06 20 45995 5290 79693083
Soft tissue swelling 20.41 19.06 12 46003 1489 79696884
Oesophagogastroduodenoscopy 20.40 19.06 7 46008 240 79698133
Fibromuscular dysplasia 20.37 19.06 7 46008 241 79698132
Hypoxia 20.24 19.06 115 45900 103128 79595245
Dyslipidaemia 20.15 19.06 29 45986 11604 79686769
Abdominal pain 20.04 19.06 137 45878 389432 79308941
Systolic dysfunction 20.03 19.06 17 45998 3778 79694595
Neoplasm progression 19.94 19.06 3 46012 51679 79646694
Hepatitis 19.83 19.06 4 46011 55723 79642650
Adverse drug reaction 19.50 19.06 83 45932 66309 79632064
Forced expiratory flow decreased 19.33 19.06 7 46008 282 79698091
Pleural thickening 19.20 19.06 15 46000 2967 79695406
Pleural rub 19.13 19.06 5 46010 65 79698308
Metabolic acidosis 19.10 19.06 12 46003 82517 79615856

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R01AD13 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R03BA08 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Glucocorticoids
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D005938 Glucocorticoids
MeSH PA D006728 Hormones

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

DiseaseRelationSNOMED_IDDOID
Allergic rhinitis indication 61582004
Asthma indication 195967001 DOID:2841
Seasonal allergic rhinitis indication 367498001
Asthma management indication 406162001
Severe chronic obstructive pulmonary disease off-label use 313299006
Mycosis contraindication 3218000 DOID:1564
Ocular hypertension contraindication 4210003 DOID:9282
Inactive tuberculosis contraindication 11999007
Epistaxis contraindication 12441001
Disease caused by parasite contraindication 17322007
Glaucoma contraindication 23986001 DOID:1686
Acute tuberculosis contraindication 25629007
Osteoporosis contraindication 64859006 DOID:11476
Operation on nose contraindication 88733004
Bilateral cataracts contraindication 95722004
Ophthalmic herpes simplex contraindication 186542001
Osteopenia contraindication 312894000
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Nasal Candidiasis contraindication
Oropharyngeal Candidiasis contraindication
Nasal Trauma contraindication
Uncontrolled Bacterial Infections contraindication
Nasal Septal Ulcers contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

ProductApplicantIngredients
Aservo EquiHaler Boehringer lngelheim Animal Health USA Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.78 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.08MG/INH ALVESCO COVIS N021658 Jan. 10, 2008 RX AEROSOL, METERED INHALATION 8371292 Feb. 1, 2028 MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND ADOLESCENT PATIENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHOD FOR TREATING A RESPIRATORY DISEASE IN A CHILD
0.16MG/INH ALVESCO COVIS N021658 Jan. 10, 2008 RX AEROSOL, METERED INHALATION 8371292 Feb. 1, 2028 MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND ADOLESCENT PATIENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHOD FOR TREATING A RESPIRATORY DISEASE IN A CHILD
0.05MG/SPRAY OMNARIS COVIS N022004 Oct. 20, 2006 RX SPRAY, METERED NASAL 8371292 Feb. 1, 2028 TREATMENT OF NASAL SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER. TREATMENT OF NASAL SYMPTOMS ASSOCIATED W PERENNIAL ALLERGIC RHINITIS IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER
0.037MG/INH ZETONNA COVIS N202129 Jan. 20, 2012 RX AEROSOL, METERED NASAL 8371292 Feb. 1, 2028 TREATMENT OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHODS FOR TREATING A RESPIRATORY DISEASE IN A CHILD

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST Ki 7.43 WOMBAT-PK CHEMBL

External reference:

IDSource
4027427 VUID
N0000179737 NUI
D01703 KEGG_DRUG
274964 RXNORM
4027427 VANDF
C0907850 UMLSCUI
CHEBI:31397 CHEBI
CHEMBL2040682 ChEMBL_ID
DB01410 DRUGBANK_ID
C120481 MESH_SUPPLEMENTAL_RECORD_UI
7469 IUPHAR_LIGAND_ID
6546 INN_ID
S59502J185 UNII
6918155 PUBCHEM_CID
132906 MMSL
19358 MMSL
89965 MMSL
d05465 MMSL
008829 NDDF
416739001 SNOMEDCT_US
417420004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Alvesco HUMAN PRESCRIPTION DRUG LABEL 1 54868-5989 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 27 sections
Alvesco HUMAN PRESCRIPTION DRUG LABEL 1 54868-5990 AEROSOL, METERED 160 ug RESPIRATORY (INHALATION) NDA 27 sections
Omnaris HUMAN PRESCRIPTION DRUG LABEL 1 54868-6020 SPRAY 50 ug NASAL NDA 13 sections
Omnaris HUMAN PRESCRIPTION DRUG LABEL 1 70515-701 SPRAY 50 ug NASAL NDA 27 sections
Omnaris HUMAN PRESCRIPTION DRUG LABEL 1 70515-701 SPRAY 50 ug NASAL NDA 27 sections
Alvesco HUMAN PRESCRIPTION DRUG LABEL 1 70515-711 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 28 sections
Alvesco HUMAN PRESCRIPTION DRUG LABEL 1 70515-711 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 28 sections
Alvesco HUMAN PRESCRIPTION DRUG LABEL 1 70515-712 AEROSOL, METERED 160 ug RESPIRATORY (INHALATION) NDA 28 sections
Alvesco HUMAN PRESCRIPTION DRUG LABEL 1 70515-712 AEROSOL, METERED 160 ug RESPIRATORY (INHALATION) NDA 28 sections
Zetonna HUMAN PRESCRIPTION DRUG LABEL 1 70515-737 AEROSOL, METERED 37 ug NASAL NDA 28 sections
Zetonna HUMAN PRESCRIPTION DRUG LABEL 1 70515-737 AEROSOL, METERED 37 ug NASAL NDA 28 sections