ciclesonide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 4.890 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 3.532 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 7.980 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 27.797 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 0.180 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 0.270 % High 1
herg hERG pIC50 4.789 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 52.723 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 244.906 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 0.300 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK 19
kinase-selectivity-class GRK2 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.791 High 1
mh-clint Mouse hepatocyte intrinsic clearance 117.490 High 1
mppb Mouse plasma protein binding (% unbound) 0.290 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 8.375 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 0.780 % High 1
rh-clint Rat hepatocyte intrinsic clearance 126.474 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 1.390 % High 1
rppb Rat plasma protein binding (% unbound) 0.250 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 0.637 uM High 1

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 2539.12 18.35 1537 42941 240623 90343346
Wheezing 1512.42 18.35 1108 43370 236972 90346997
Obstructive airways disorder 1385.29 18.35 509 43969 25360 90558609
Dyspnoea 718.21 18.35 1425 43053 879530 89704439
Therapeutic product effect incomplete 705.32 18.35 654 43824 193242 90390727
Sleep disorder due to a general medical condition 678.61 18.35 363 44115 44375 90539594
Cough 674.08 18.35 865 43613 368097 90215872
Full blood count abnormal 646.74 18.35 329 44149 36268 90547701
Productive cough 587.49 18.35 402 44076 76661 90507308
Sputum discoloured 542.73 18.35 243 44235 20148 90563821
Forced expiratory volume decreased 451.54 18.35 151 44327 5657 90578312
Asthma-chronic obstructive pulmonary disease overlap syndrome 435.70 18.35 141 44337 4758 90579211
Chest discomfort 427.47 18.35 427 44051 137938 90446031
Nasal polyps 413.59 18.35 167 44311 10713 90573256
Loss of personal independence in daily activities 413.05 18.35 416 44062 135689 90448280
Total lung capacity increased 388.19 18.35 130 44348 4891 90579078
Middle insomnia 350.44 18.35 169 44309 16582 90567387
Bronchiectasis 343.50 18.35 183 44295 22147 90561822
Sarcoidosis 318.88 18.35 138 44340 10535 90573434
Bacterial disease carrier 287.56 18.35 82 44396 1784 90582185
Pneumonia viral 286.44 18.35 121 44357 8702 90575267
Rhinitis allergic 270.73 18.35 142 44336 16643 90567326
Bronchial secretion retention 269.18 18.35 91 44387 3524 90580445
Rhinitis 263.10 18.35 130 44348 13442 90570527
Chronic obstructive pulmonary disease 261.91 18.35 246 44232 73583 90510386
Cardiac murmur 238.05 18.35 134 44344 18060 90565909
Bronchial wall thickening 238.04 18.35 73 44405 2058 90581911
Soft tissue disorder 216.82 18.35 81 44397 4209 90579760
Restrictive pulmonary disease 189.91 18.35 63 44415 2299 90581670
Hypomania 189.81 18.35 91 44387 8806 90575163
Heart rate increased 188.59 18.35 254 44224 112648 90471321
Jaundice cholestatic 188.15 18.35 94 44384 9949 90574020
Lung neoplasm malignant 180.90 18.35 125 44353 24148 90559821
Eosinophilia 180.55 18.35 133 44345 28400 90555569
Breath sounds abnormal 179.05 18.35 105 44373 15281 90568688
Sputum purulent 175.49 18.35 52 44426 1300 90582669
Gastrooesophageal reflux disease 175.25 18.35 302 44176 166035 90417934
Blood pressure increased 174.64 18.35 332 44146 196885 90387084
Superinfection 169.19 18.35 62 44416 3050 90580919
Nasal congestion 168.11 18.35 206 44272 83208 90500761
Sleep apnoea syndrome 161.52 18.35 130 44348 31617 90552352
Blood immunoglobulin E increased 158.14 18.35 65 44413 4360 90579609
Schizophrenia 155.92 18.35 95 44383 14819 90569150
Dyspnoea exertional 154.60 18.35 184 44294 72104 90511865
Infusion related reaction 153.41 18.35 14 44464 416766 90167203
Illness 145.45 18.35 190 44288 81779 90502190
Psychotic disorder 140.34 18.35 119 44359 31111 90552858
Bronchospasm 138.89 18.35 100 44378 20609 90563360
Lung diffusion test abnormal 137.92 18.35 32 44446 292 90583677
Pneumonia 132.56 18.35 641 43837 637418 89946551
Herpes zoster 131.45 18.35 195 44283 94449 90489520
Blood test abnormal 131.06 18.35 97 44381 20855 90563114
Glossodynia 129.36 18.35 7 44471 321772 90262197
Arthropathy 127.80 18.35 15 44463 366227 90217742
Hand deformity 127.30 18.35 4 44474 296358 90287611
Secretion discharge 123.50 18.35 84 44394 15812 90568157
Pericarditis 118.41 18.35 3 44475 270148 90313821
Bronchial neoplasm 117.47 18.35 31 44447 499 90583470
Off label use 116.21 18.35 229 44249 1102023 89481946
Bronchial haemorrhage 115.65 18.35 32 44446 621 90583348
Nicotine dependence 113.17 18.35 35 44443 1015 90582954
Confusional state 112.19 18.35 26 44452 386179 90197790
Bronchial disorder 111.40 18.35 38 44440 1512 90582457
Nasal turbinate hypertrophy 109.05 18.35 33 44445 888 90583081
Cholelithiasis 107.91 18.35 131 44347 52375 90531594
Rash 107.73 18.35 140 44338 795960 89788009
Contraindicated product administered 107.11 18.35 15 44463 320124 90263845
Sinus operation 107.10 18.35 44 44434 2947 90581022
Factor V Leiden mutation 102.63 18.35 25 44453 286 90583683
Hyper IgE syndrome 99.91 18.35 27 44451 478 90583491
Toxicity to various agents 99.87 18.35 12 44466 287834 90296135
Reversible airways obstruction 98.60 18.35 37 44441 1946 90582023
Rales 98.37 18.35 73 44405 15754 90568215
Psoriatic arthropathy 98.33 18.35 3 44475 228332 90355637
Arthritis 97.66 18.35 238 44240 167077 90416892
Impaired healing 97.65 18.35 4 44474 234195 90349774
Diarrhoea 97.26 18.35 197 44281 938993 89644976
Endometrial ablation 97.15 18.35 31 44447 998 90582971
Asthma exercise induced 95.44 18.35 26 44452 475 90583494
Treatment failure 95.44 18.35 17 44461 303911 90280058
Influenza 95.43 18.35 211 44267 139053 90444916
Scoliosis 93.78 18.35 57 44421 8850 90575119
Respiratory tract congestion 92.68 18.35 89 44389 27321 90556648
Crepitations 91.54 18.35 56 44422 8796 90575173
Oral pain 90.10 18.35 95 44383 32588 90551381
Upper-airway cough syndrome 90.04 18.35 68 44410 15067 90568902
Body temperature decreased 89.49 18.35 82 44396 23734 90560235
Secondary immunodeficiency 89.01 18.35 35 44443 2091 90581878
Acute kidney injury 88.33 18.35 24 44454 320363 90263606
Cryopyrin associated periodic syndrome 87.69 18.35 25 44453 543 90583426
Dysphonia 87.60 18.35 130 44348 62954 90521015
Glaucoma 84.97 18.35 75 44403 20680 90563289
Idiopathic intracranial hypertension 83.66 18.35 39 44439 3542 90580427
Irritable bowel syndrome 81.85 18.35 5 44473 207443 90376526
Pulmonary function test decreased 81.05 18.35 41 44437 4453 90579516
Blister 80.62 18.35 14 44464 254984 90328985
Oropharyngeal pain 80.58 18.35 176 44302 115011 90468958
Death 80.16 18.35 64 44414 456487 90127482
Anti-cyclic citrullinated peptide antibody positive 79.24 18.35 11 44467 236422 90347547
Drug interaction 77.54 18.35 20 44458 276433 90307536
Atelectasis 76.44 18.35 76 44402 24333 90559636
Allergy to animal 75.52 18.35 29 44449 1625 90582344
Kyphosis 75.24 18.35 34 44444 2874 90581095
Throat clearing 74.99 18.35 37 44441 3810 90580159
Forced vital capacity decreased 73.54 18.35 26 44452 1152 90582817
Ventricular failure 73.38 18.35 20 44458 366 90583603
Nonspecific reaction 73.18 18.35 33 44445 2776 90581193
Broncholithiasis 73.06 18.35 19 44459 288 90583681
Intentional product use issue 72.90 18.35 10 44468 216882 90367087
Blood bilirubin increased 72.82 18.35 98 44380 43372 90540597
Therapeutic product effect decreased 72.46 18.35 23 44455 277548 90306421
Rhonchi 71.34 18.35 33 44445 2945 90581024
Rib deformity 69.89 18.35 18 44460 262 90583707
Hypoventilation 69.24 18.35 39 44439 5257 90578712
Alopecia 68.98 18.35 85 44393 494986 90088983
Lymph node calcification 68.55 18.35 19 44459 371 90583598
Viral infection 67.30 18.35 92 44386 41322 90542647
Eosinophil count increased 65.32 18.35 53 44425 13028 90570941
Rheumatoid arthritis 64.67 18.35 50 44428 362564 90221405
Bronchitis 64.50 18.35 193 44285 152734 90431235
Rib fracture 64.40 18.35 72 44406 26363 90557606
Hepatotoxicity 62.96 18.35 94 44384 45748 90538221
Skin lesion 62.22 18.35 84 44394 37281 90546688
CFTR gene mutation 62.12 18.35 16 44462 233 90583736
Respiratory rate increased 61.89 18.35 56 44422 15945 90568024
Increased bronchial secretion 61.56 18.35 27 44451 2126 90581843
Neutropenia 59.83 18.35 18 44460 224886 90359083
Muscle tension dysphonia 59.22 18.35 16 44462 283 90583686
Thrombocytopenia 58.71 18.35 15 44463 208710 90375259
Liver function test abnormal 58.36 18.35 96 44382 50749 90533220
Pulmonary mass 57.83 18.35 71 44407 28701 90555268
Maternal exposure during pregnancy 57.68 18.35 55 44423 360008 90223961
Nasal obstruction 56.57 18.35 27 44451 2585 90581384
Injury 55.85 18.35 14 44464 197335 90386634
Abdominal discomfort 55.57 18.35 93 44385 477235 90106734
Discomfort 55.35 18.35 33 44445 274302 90309667
Blood pressure systolic increased 55.01 18.35 101 44377 58244 90525725
Joint range of motion decreased 54.32 18.35 3 44475 135640 90448329
Swelling 53.20 18.35 77 44401 418981 90164988
Decreased appetite 53.10 18.35 64 44414 376476 90207493
Nasopharyngitis 52.65 18.35 361 44117 406743 90177226
Venous pressure jugular increased 52.25 18.35 17 44461 583 90583386
Emphysema 51.91 18.35 45 44433 12110 90571859
Wound 51.24 18.35 44 44434 302936 90281033
Myalgia 50.84 18.35 195 44283 174930 90409039
Affective disorder 50.81 18.35 37 44441 7756 90576213
Exposure to allergen 49.59 18.35 16 44462 534 90583435
Eczema 49.18 18.35 91 44387 52779 90531190
Fibromuscular dysplasia 49.11 18.35 14 44464 304 90583665
Neurosensory hypoacusis 48.99 18.35 13 44465 214 90583755
Granuloma 48.79 18.35 33 44445 6152 90577817
Asthmatic crisis 48.37 18.35 22 44456 1888 90582081
Sinus disorder 47.83 18.35 71 44407 34376 90549593
Mycobacterium avium complex infection 47.76 18.35 28 44450 4070 90579899
Respiratory tract inflammation 47.71 18.35 16 44462 604 90583365
White blood cell count decreased 47.00 18.35 12 44466 167097 90416872
Inflammation 46.23 18.35 15 44463 178577 90405392
Aggression 46.00 18.35 61 44417 26607 90557362
Blood immunoglobulin E decreased 45.66 18.35 12 44466 190 90583779
Musculoskeletal stiffness 45.52 18.35 47 44431 296485 90287484
Respiratory disorder 45.26 18.35 99 44379 64717 90519252
Hypoaesthesia 44.72 18.35 53 44425 314157 90269812
Airway remodelling 44.38 18.35 10 44468 79 90583890
Oropharyngeal discomfort 44.35 18.35 34 44444 7701 90576268
Eosinophilic pneumonia chronic 44.06 18.35 12 44466 219 90583750
Fear of disease 43.80 18.35 19 44459 1457 90582512
Ankle fracture 43.76 18.35 52 44426 20318 90563651
Gastrointestinal disorder 43.73 18.35 37 44441 256650 90327319
Seasonal allergy 43.44 18.35 55 44423 22928 90561041
Oedema 43.43 18.35 22 44456 200273 90383696
Peak expiratory flow rate decreased 43.26 18.35 15 44463 627 90583342
Hypotension 43.07 18.35 58 44420 325339 90258630
Stomatitis 42.77 18.35 43 44435 274655 90309314
Eosinophilic granulomatosis with polyangiitis 42.49 18.35 22 44456 2508 90581461
Eosinophil count abnormal 42.48 18.35 16 44462 850 90583119
Therapy non-responder 42.12 18.35 8 44470 136696 90447273
Abscess 41.87 18.35 49 44429 18842 90565127
Polycystic ovaries 41.84 18.35 29 44449 5625 90578344
Oedema peripheral 41.56 18.35 242 44236 257673 90326296
Tympanosclerosis 40.41 18.35 9 44469 67 90583902
Platelet count decreased 40.16 18.35 9 44469 136960 90447009
Limb injury 39.59 18.35 62 44416 31446 90552523
Malaise 39.36 18.35 450 44028 585536 89998433
Pancytopenia 39.34 18.35 6 44472 120257 90463712
Eye allergy 39.26 18.35 17 44461 1298 90582671
Malignant neoplasm progression 38.18 18.35 4 44474 106866 90477103
FEV1/FVC ratio decreased 37.89 18.35 10 44468 161 90583808
Hypokalaemia 37.68 18.35 9 44469 131107 90452862
Respiratory tract infection 37.63 18.35 87 44391 58991 90524978
Abdominal pain upper 37.60 18.35 66 44412 332608 90251361
Humidity intolerance 36.98 18.35 12 44466 408 90583561
Stress 36.47 18.35 105 44373 81290 90502679
Decreased activity 36.35 18.35 31 44447 8161 90575808
Sensitivity to weather change 36.06 18.35 32 44446 8882 90575087
Pulmonary congestion 35.93 18.35 46 44432 19387 90564582
Disease progression 35.79 18.35 16 44462 156599 90427370
Weight decreased 35.78 18.35 313 44165 379597 90204372
Lip pruritus 35.50 18.35 16 44462 1344 90582625
Pulmonary function test abnormal 35.35 18.35 20 44458 2719 90581250
Pancreatitis relapsing 35.32 18.35 16 44462 1360 90582609
Chest X-ray abnormal 35.12 18.35 25 44453 5057 90578912
Febrile neutropenia 34.92 18.35 17 44461 158332 90425637
Mobility decreased 34.92 18.35 43 44435 250691 90333278
Crystal arthropathy 34.90 18.35 11 44467 340 90583629
Vocal cord dysfunction 34.62 18.35 14 44464 900 90583069
Grip strength decreased 34.30 18.35 3 44475 92573 90491396
Bursitis 34.17 18.35 11 44467 131643 90452326
Nausea 34.02 18.35 365 44113 1109951 89474018
Lipohypertrophy 33.89 18.35 13 44465 726 90583243
Adverse event 33.86 18.35 8 44470 117410 90466559
Rectal prolapse 33.22 18.35 18 44460 2249 90581720
Breast neoplasm 33.21 18.35 16 44462 1564 90582405
Exposure during pregnancy 33.08 18.35 41 44437 238369 90345600
Musculoskeletal pain 32.60 18.35 22 44456 171229 90412740
Psoriasis 32.37 18.35 16 44462 147738 90436231
Peak expiratory flow rate abnormal 32.12 18.35 8 44470 101 90583868
Allergic sinusitis 31.59 18.35 17 44461 2096 90581873
Forced expiratory flow decreased 31.55 18.35 8 44470 109 90583860
Frustration tolerance decreased 31.26 18.35 28 44450 7868 90576101
Croup infectious 31.20 18.35 12 44466 675 90583294
Angioplasty 31.17 18.35 15 44463 1462 90582507
Granulomatosis with polyangiitis 31.02 18.35 18 44460 2567 90581402
Dyslipidaemia 30.78 18.35 31 44447 10076 90573893
Dehydration 30.76 18.35 30 44448 194417 90389552
Nasal mucosal disorder 30.76 18.35 16 44462 1841 90582128
Gastrointestinal haemorrhage 30.69 18.35 4 44474 90244 90493725
Product use in unapproved indication 30.18 18.35 76 44402 336160 90247809
Wound infection 29.23 18.35 8 44470 106394 90477575
Spinal cord compression 29.06 18.35 22 44456 4889 90579080
Blood creatinine increased 29.05 18.35 7 44471 101379 90482590
Overdose 29.04 18.35 21 44457 157688 90426281
Lung diffusion test decreased 28.99 18.35 12 44466 819 90583150
Spirometry abnormal 28.94 18.35 9 44469 266 90583703
Forearm fracture 28.68 18.35 11 44467 614 90583355
Hyponatraemia 28.45 18.35 15 44463 133523 90450446
Drug-induced liver injury 28.43 18.35 5 44473 90313 90493656
Liver disorder 28.33 18.35 12 44466 121257 90462712
Mycobacterium tuberculosis complex test positive 28.23 18.35 17 44461 2595 90581374
Medication error 28.20 18.35 4 44474 84648 90499321
Animal scratch 28.13 18.35 15 44463 1815 90582154
Choking 27.99 18.35 32 44446 12001 90571968
Pulmonary fibrosis 27.86 18.35 9 44469 107494 90476475
Oxygen saturation decreased 27.42 18.35 115 44363 107368 90476601
Respiratory symptom 27.29 18.35 20 44458 4232 90579737
Alanine aminotransferase increased 27.18 18.35 12 44466 118326 90465643
Lung neoplasm 26.89 18.35 24 44454 6711 90577258
Bronchial hyperreactivity 26.83 18.35 15 44463 1993 90581976
Urinary tract infection 26.72 18.35 70 44408 305562 90278407
Bronchial obstruction 26.41 18.35 14 44464 1675 90582294
Ligament pain 26.30 18.35 8 44470 219 90583750
Forced expiratory volume 26.18 18.35 5 44473 15 90583954
Polyp 26.18 18.35 25 44453 7619 90576350
Lower limb fracture 26.13 18.35 5 44473 85008 90498961
Gestational diabetes 26.08 18.35 29 44449 10553 90573416
Immunisation reaction 26.06 18.35 11 44467 789 90583180
Intentional product misuse 26.04 18.35 6 44472 89598 90494371
Lung hyperinflation 25.84 18.35 13 44465 1395 90582574
Live birth 25.75 18.35 4 44474 79103 90504866
Nocturnal dyspnoea 25.57 18.35 13 44465 1427 90582542
Respiration abnormal 25.31 18.35 25 44453 7938 90576031
Tongue oedema 24.94 18.35 21 44457 5433 90578536
Sinusitis 24.59 18.35 267 44211 342821 90241148
Aphonia 24.11 18.35 30 44448 12289 90571680
Liver function test increased 24.03 18.35 6 44472 84849 90499120
Sinus tachycardia 23.95 18.35 47 44431 28466 90555503
Sepsis 23.82 18.35 32 44446 179782 90404187
Renal impairment 23.73 18.35 11 44467 105410 90478559
Myocardial infarction 23.70 18.35 109 44369 105863 90478106
Tenderness 23.44 18.35 45 44433 26823 90557146
Amnesia 23.39 18.35 12 44466 108493 90475476
Upper airway obstruction 23.37 18.35 11 44467 1021 90582948
Joint stiffness 23.13 18.35 5 44473 78037 90505932
Red blood cell sedimentation rate increased 23.09 18.35 6 44472 82589 90501380
Depressed level of consciousness 22.97 18.35 4 44474 72780 90511189
Rhinorrhoea 22.92 18.35 95 44383 88221 90495748
Aspartate aminotransferase increased 22.77 18.35 11 44467 102926 90481043
Autoimmune disorder 22.58 18.35 5 44473 76739 90507230
Dry mouth 22.18 18.35 35 44443 184024 90399945
Sciatica 22.17 18.35 11 44467 101371 90482598
Pain 22.16 18.35 350 44128 995991 89587978
Nasal discharge discolouration 21.97 18.35 15 44463 2838 90581131
Terminal insomnia 21.66 18.35 11 44467 1204 90582765
Road traffic accident 21.61 18.35 13 44465 107613 90476356
Lung diffusion disorder 21.61 18.35 6 44472 118 90583851
Paranasal sinus inflammation 21.53 18.35 9 44469 630 90583339
Eosinophilic bronchitis 21.47 18.35 9 44469 634 90583335
Forced expiratory volume abnormal 21.47 18.35 6 44472 121 90583848
Night sweats 21.38 18.35 19 44459 128747 90455222
Leukopenia 21.36 18.35 102 44376 100608 90483361
Blood immunoglobulin E 21.23 18.35 5 44473 49 90583920
Sinus pain 21.11 18.35 19 44459 5370 90578599
Skin exfoliation 20.86 18.35 4 44474 67909 90516060
Coronary artery disease 20.84 18.35 49 44429 33574 90550395
Claustrophobia 20.75 18.35 11 44467 1316 90582653
Pharyngeal swelling 20.73 18.35 25 44453 9919 90574050
Laryngeal stenosis 20.65 18.35 11 44467 1328 90582641
Hepatic enzyme increased 20.56 18.35 99 44379 360637 90223332
Gait inability 20.50 18.35 25 44453 146431 90437538
Impaired quality of life 20.48 18.35 39 44439 23105 90560864
Soft tissue swelling 20.36 18.35 11 44467 1367 90582602
Taste disorder 20.29 18.35 3 44475 61543 90522426
Fluid retention 20.12 18.35 9 44469 88082 90495887
Bundle branch block left 20.11 18.35 22 44456 7863 90576106
Chondrocalcinosis pyrophosphate 20.10 18.35 10 44468 1048 90582921
Vaccination complication 20.09 18.35 10 44468 1049 90582920
Pleural rub 20.08 18.35 5 44473 63 90583906
Smoke sensitivity 20.03 18.35 8 44470 498 90583471
Atrial fibrillation 19.98 18.35 123 44355 133488 90450481
Prescribed underdose 19.94 18.35 6 44472 75013 90508956
Vomiting 19.92 18.35 270 44208 788023 89795946
Dyspnoea paroxysmal nocturnal 19.91 18.35 10 44468 1070 90582899
Muscular weakness 19.89 18.35 45 44433 206621 90377348
Chronic sinusitis 19.71 18.35 39 44439 23763 90560206
Neuropathy peripheral 19.58 18.35 23 44455 136947 90447022
Haemoglobin decreased 19.32 18.35 31 44447 161925 90422044
Disease recurrence 19.27 18.35 51 44427 37602 90546367
Oesophagogastroduodenoscopy 19.24 18.35 6 44472 179 90583790
Pulmonary eosinophilia 19.03 18.35 7 44471 348 90583621
Laryngitis fungal 18.81 18.35 6 44472 193 90583776
Treatment noncompliance 18.76 18.35 62 44416 51665 90532304
Post procedural infection 18.59 18.35 25 44453 11049 90572920
Osteoarthritis 18.53 18.35 43 44435 195687 90388282
Seizure 18.41 18.35 29 44449 152600 90431369

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 2096.18 29.88 905 22858 61409 42536163
Wheezing 1404.13 29.88 659 23104 54122 42543450
Obstructive airways disorder 1202.72 29.88 469 23294 24290 42573282
Therapeutic product effect incomplete 993.62 29.88 569 23194 70370 42527202
Full blood count abnormal 981.65 29.88 428 23335 29448 42568124
Productive cough 690.10 29.88 402 23361 51165 42546407
Sleep disorder due to a general medical condition 628.42 29.88 267 23496 17186 42580386
Loss of personal independence in daily activities 584.71 29.88 357 23406 49459 42548113
Bronchiectasis 498.03 29.88 229 23534 17790 42579782
Dust allergy 394.97 29.88 138 23625 5194 42592378
Mite allergy 371.47 29.88 130 23633 4916 42592656
Conjunctivitis allergic 369.87 29.88 135 23628 5776 42591796
Breath sounds abnormal 369.87 29.88 165 23598 11928 42585644
Eosinophilic granulomatosis with polyangiitis 360.76 29.88 147 23616 8491 42589081
Mycotic allergy 360.02 29.88 126 23637 4765 42592807
Spirometry abnormal 357.55 29.88 127 23636 5019 42592553
Dyspnoea 340.43 29.88 754 23009 441867 42155705
Nodule 339.05 29.88 157 23606 12377 42585195
Forced expiratory volume decreased 332.91 29.88 134 23629 7496 42590076
Respiratory symptom 300.02 29.88 139 23624 10967 42586605
Pulmonary function test decreased 275.62 29.88 108 23655 5624 42591948
Normochromic normocytic anaemia 275.41 29.88 123 23640 8908 42588664
Nasal polyps 267.36 29.88 95 23668 3756 42593816
Asthma-chronic obstructive pulmonary disease overlap syndrome 246.99 29.88 72 23691 1487 42596085
Sputum discoloured 246.54 29.88 118 23645 10014 42587558
Neuritis 229.78 29.88 97 23666 6123 42591449
Congenital hiatus hernia 227.13 29.88 96 23667 6078 42591494
Arteriosclerosis coronary artery 226.79 29.88 137 23626 18540 42579032
Pulmonary vasculitis 222.45 29.88 95 23668 6171 42591401
Cough 208.32 29.88 363 23400 177740 42419832
Nasal congestion 207.31 29.88 154 23609 29347 42568225
Malignant melanoma in situ 198.69 29.88 70 23693 2697 42594875
Neurological symptom 191.64 29.88 99 23664 9892 42587680
Eosinophil count increased 184.70 29.88 99 23664 10664 42586908
Chest discomfort 181.98 29.88 200 23563 63416 42534156
Arteriosclerosis 180.70 29.88 117 23646 17872 42579700
Blood immunoglobulin E increased 173.19 29.88 68 23695 3557 42594015
Respiratory disorder 172.66 29.88 123 23640 21962 42575610
Dyspnoea exertional 170.70 29.88 173 23590 49975 42547597
Hypoxia 168.53 29.88 201 23562 69585 42527987
Acute kidney injury 162.43 29.88 11 23752 367326 42230246
Nasal obstruction 157.55 29.88 46 23717 955 42596617
Sinus pain 156.46 29.88 45 23718 884 42596688
Bronchial hyperreactivity 154.70 29.88 53 23710 1876 42595696
Pulmonary alveolar haemorrhage 152.83 29.88 98 23665 14718 42582854
Eosinophil count abnormal 150.26 29.88 36 23727 332 42597240
Chronic sinusitis 149.39 29.88 60 23703 3332 42594240
Airway remodelling 148.92 29.88 43 23720 857 42596715
Vasculitis 145.05 29.88 103 23660 18291 42579281
Total lung capacity abnormal 143.42 29.88 63 23700 4380 42593192
Antineutrophil cytoplasmic antibody positive 134.80 29.88 60 23703 4305 42593267
Atopy 128.23 29.88 39 23724 936 42596636
Haemoptysis 126.53 29.88 142 23621 46025 42551547
Chronic obstructive pulmonary disease 123.96 29.88 164 23599 62950 42534622
Benign prostatic hyperplasia 121.87 29.88 98 23665 20954 42576618
Adrenal suppression 120.11 29.88 37 23726 928 42596644
Gastrooesophageal reflux disease 115.79 29.88 134 23629 44889 42552683
Central nervous system mass 111.74 29.88 34 23729 817 42596755
Wall motion score index abnormal 111.59 29.88 34 23729 821 42596751
Micturition urgency 106.41 29.88 72 23691 11826 42585746
Toxicity to various agents 103.72 29.88 6 23757 229130 42368442
Gingival disorder 102.34 29.88 37 23726 1537 42596035
Pulmonary fibrosis 101.78 29.88 98 23665 26583 42570989
Joint injury 101.66 29.88 76 23687 14600 42582972
Hypercholesterolaemia 101.40 29.88 72 23691 12777 42584795
Mycobacterium avium complex infection 101.20 29.88 44 23719 2983 42594589
Cardiac septal defect 99.46 29.88 32 23731 928 42596644
Pulmonary function test abnormal 99.43 29.88 42 23721 2652 42594920
Eosinophilic myocarditis 95.77 29.88 34 23729 1339 42596233
Lung disorder 93.25 29.88 124 23639 47799 42549773
Drug interaction 93.20 29.88 18 23745 266981 42330591
Microangiopathy 89.04 29.88 34 23729 1648 42595924
Hypothyroidism 88.42 29.88 99 23664 31985 42565587
Sputum increased 86.66 29.88 40 23723 3123 42594449
Transient ischaemic attack 84.36 29.88 99 23664 33640 42563932
Lung consolidation 83.65 29.88 50 23713 6627 42590945
Neutropenia 82.36 29.88 8 23755 199423 42398149
Thrombocytopenia 80.27 29.88 7 23756 190272 42407300
Capillaritis 79.79 29.88 34 23729 2194 42595378
Anaemia 78.76 29.88 29 23734 280249 42317323
Diarrhoea 77.43 29.88 86 23677 460763 42136809
Vital capacity decreased 73.67 29.88 22 23741 495 42597077
Seasonal allergy 72.63 29.88 49 23714 8006 42589566
Eye disorder 69.20 29.88 55 23708 11557 42586015
Influenza 68.88 29.88 124 23639 62051 42535521
Oral disorder 68.10 29.88 39 23724 4773 42592799
Emphysema 66.16 29.88 54 23709 11781 42585791
Upper-airway cough syndrome 66.15 29.88 37 23726 4329 42593243
Osteopenia 65.90 29.88 42 23721 6236 42591336
Throat irritation 63.63 29.88 55 23708 12981 42584591
Eosinophil count 63.50 29.88 16 23747 185 42597387
Decreased activity 63.15 29.88 38 23725 5097 42592475
Lower respiratory tract infection 62.94 29.88 95 23668 41111 42556461
Death 62.87 29.88 104 23659 471081 42126491
Sinusitis 62.48 29.88 102 23661 47190 42550382
Vocal cord dysfunction 62.21 29.88 16 23747 202 42597370
Eosinophil count decreased 61.63 29.88 33 23730 3543 42594029
Thrombosis 61.55 29.88 125 23638 68386 42529186
Platelet count decreased 61.53 29.88 4 23759 138577 42458995
Rhinorrhoea 61.41 29.88 82 23681 31712 42565860
Eosinophilic pneumonia 59.76 29.88 36 23727 4838 42592734
Skin irritation 58.73 29.88 42 23721 7532 42590040
Nausea 57.27 29.88 83 23680 396716 42200856
Pulmonary mass 56.90 29.88 57 23706 16208 42581364
Disease progression 56.15 29.88 7 23756 143649 42453923
Pleural thickening 53.27 29.88 17 23746 480 42597092
Sepsis 52.07 29.88 23 23740 199311 42398261
Suffocation feeling 51.61 29.88 18 23745 672 42596900
Middle insomnia 50.78 29.88 39 23724 7794 42589778
Constipation 50.48 29.88 14 23749 162277 42435295
Malignant neoplasm progression 48.50 29.88 3 23760 108397 42489175
Pancytopenia 47.85 29.88 5 23758 117738 42479834
Vomiting 47.52 29.88 55 23708 289668 42307904
Kidney infection 46.74 29.88 35 23728 6735 42590837
Inspiratory capacity abnormal 46.15 29.88 11 23752 99 42597473
Rhinitis allergic 46.13 29.88 28 23735 3814 42593758
Diaphragmatic disorder 44.67 29.88 19 23744 1220 42596352
Asthenia 44.24 29.88 55 23708 280738 42316834
White blood cell count decreased 44.07 29.88 5 23758 110391 42487181
Ventricular hypokinesia 44.02 29.88 34 23729 6850 42590722
Bronchitis 43.42 29.88 87 23676 47114 42550458
Bronchial wall thickening 42.97 29.88 19 23744 1341 42596231
Blood creatinine increased 41.45 29.88 6 23757 109997 42487575
Joint warmth 41.28 29.88 15 23748 632 42596940
Oesophageal polyp 40.95 29.88 9 23754 54 42597518
Lacrimation increased 40.74 29.88 41 23722 11717 42585855
Somnolence 40.59 29.88 14 23749 141091 42456481
Viral infection 40.40 29.88 56 23707 22427 42575145
Eye swelling 40.27 29.88 41 23722 11879 42585693
Bronchial obstruction 38.61 29.88 19 23744 1710 42595862
Sensitivity to weather change 38.46 29.88 20 23743 2023 42595549
Renal failure 38.44 29.88 16 23747 143710 42453862
Haemoglobin decreased 38.35 29.88 13 23750 132458 42465114
Sneezing 37.61 29.88 30 23733 6333 42591239
Dehydration 37.57 29.88 16 23747 141751 42455821
Septic shock 36.97 29.88 4 23759 91668 42505904
Infective exacerbation of chronic obstructive airways disease 35.70 29.88 19 23744 2014 42595558
Adrenal insufficiency 35.30 29.88 48 23715 18876 42578696
Gastrointestinal haemorrhage 35.30 29.88 6 23757 97720 42499852
Hypotension 35.05 29.88 56 23707 257575 42339997
Hyponatraemia 34.99 29.88 7 23756 101455 42496117
Overdose 34.80 29.88 8 23755 105256 42492316
Respiratory tract congestion 34.67 29.88 31 23732 7647 42589925
Nasopharyngitis 34.35 29.88 114 23649 83882 42513690
Febrile neutropenia 34.07 29.88 32 23731 185671 42411901
Peak expiratory flow rate decreased 34.07 29.88 9 23754 127 42597445
Condition aggravated 33.92 29.88 255 23508 260499 42337073
Vascular shunt 32.93 29.88 7 23756 35 42597537
Pulmonary embolism 32.89 29.88 143 23620 119469 42478103
Alanine aminotransferase increased 32.89 29.88 5 23758 88401 42509171
Multiple organ dysfunction syndrome 32.83 29.88 7 23756 97028 42500544
Glaucoma 32.77 29.88 31 23732 8217 42589355
Eczema 32.76 29.88 64 23699 34022 42563550
Panic reaction 32.75 29.88 17 23746 1713 42595859
Rhabdomyolysis 32.51 29.88 3 23760 78016 42519556
Upper respiratory tract congestion 31.80 29.88 14 23749 978 42596594
Cardiac failure 31.78 29.88 10 23753 106846 42490726
Hyperkalaemia 31.23 29.88 4 23759 80454 42517118
Restrictive pulmonary disease 30.50 29.88 15 23748 1348 42596224
Off label use 29.98 29.88 221 23542 638114 41959458

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 3722.27 19.61 2090 60040 248201 110278968
Obstructive airways disorder 2317.39 19.61 898 61232 45251 110481918
Wheezing 2303.96 19.61 1552 60578 253678 110273491
Full blood count abnormal 1502.97 19.61 699 61431 55353 110471816
Therapeutic product effect incomplete 1228.53 19.61 1011 61119 222794 110304375
Productive cough 1223.51 19.61 775 61355 113530 110413639
Sleep disorder due to a general medical condition 924.44 19.61 491 61639 51621 110475548
Dyspnoea 831.33 19.61 1877 60253 1104995 109422174
Cough 812.03 19.61 1139 60991 460502 110066667
Sputum discoloured 731.41 19.61 343 61787 27602 110499567
Forced expiratory volume decreased 730.72 19.61 276 61854 12900 110514269
Loss of personal independence in daily activities 709.86 19.61 623 61507 149397 110377772
Bronchiectasis 690.17 19.61 359 61771 36134 110491035
Asthma-chronic obstructive pulmonary disease overlap syndrome 617.43 19.61 202 61928 6142 110521027
Nasal polyps 567.74 19.61 230 61900 12970 110514199
Chest discomfort 520.86 19.61 562 61568 173286 110353883
Breath sounds abnormal 503.57 19.61 258 61872 25146 110502023
Chronic obstructive pulmonary disease 408.60 19.61 398 61732 108760 110418409
Dust allergy 407.70 19.61 146 61984 5855 110521314
Middle insomnia 399.92 19.61 206 61924 20296 110506873
Eosinophilic granulomatosis with polyangiitis 391.27 19.61 166 61964 10520 110516649
Spirometry abnormal 385.79 19.61 137 61993 5360 110521809
Mite allergy 378.54 19.61 137 61993 5666 110521503
Total lung capacity increased 372.45 19.61 131 61999 4981 110522188
Conjunctivitis allergic 369.14 19.61 141 61989 6790 110520379
Mycotic allergy 345.62 19.61 129 62001 5825 110521344
Nasal congestion 330.25 19.61 338 61792 97944 110429225
Dyspnoea exertional 323.00 19.61 343 61787 103717 110423452
Respiratory symptom 311.34 19.61 157 61973 14788 110512381
Rhinitis allergic 306.69 19.61 165 61965 17757 110509412
Pulmonary function test decreased 304.81 19.61 131 61999 8569 110518600
Blood immunoglobulin E increased 293.23 19.61 122 62008 7360 110519809
Gastrooesophageal reflux disease 278.60 19.61 419 61711 179557 110347612
Sarcoidosis 276.35 19.61 137 61993 12442 110514727
Bacterial disease carrier 260.77 19.61 82 62048 2187 110524982
Bronchial secretion retention 248.99 19.61 97 62033 4927 110522242
Acute kidney injury 243.89 19.61 34 62096 635396 109891773
Normochromic normocytic anaemia 239.74 19.61 126 62004 12931 110514238
Congenital hiatus hernia 228.36 19.61 97 62033 6162 110521007
Pulmonary vasculitis 220.71 19.61 96 62034 6464 110520705
Restrictive pulmonary disease 216.53 19.61 78 62052 3181 110523988
Nodule 216.06 19.61 165 61965 32466 110494703
Neuritis 215.93 19.61 98 62032 7301 110519868
Toxicity to various agents 212.15 19.61 15 62115 480540 110046629
Bronchial wall thickening 202.78 19.61 74 62056 3133 110524036
Arteriosclerosis coronary artery 197.79 19.61 141 61989 24977 110502192
Eosinophil count increased 193.53 19.61 130 62000 20928 110506241
Cardiac murmur 193.36 19.61 138 61992 24490 110502679
Illness 184.18 19.61 229 61901 81942 110445227
Malignant melanoma in situ 181.26 19.61 70 62060 3472 110523697
Rhinitis 178.54 19.61 127 62003 22418 110504751
Airway remodelling 177.97 19.61 50 62080 892 110526277
Hypomania 171.88 19.61 93 62037 10117 110517052
Heart rate increased 170.78 19.61 297 61833 143537 110383632
Drug interaction 169.47 19.61 37 62093 500146 110027023
Influenza 168.92 19.61 324 61806 168777 110358392
Bronchial hyperreactivity 167.09 19.61 66 62064 3478 110523691
Eosinophilia 165.73 19.61 183 61947 57753 110469416
Neurological symptom 164.53 19.61 105 62025 15503 110511666
Arteriosclerosis 163.44 19.61 125 62005 24642 110502527
Infusion related reaction 159.58 19.61 15 62115 381147 110146022
Pneumonia viral 156.12 19.61 90 62040 11067 110516102
Upper-airway cough syndrome 155.65 19.61 102 62028 15755 110511414
Total lung capacity abnormal 150.70 19.61 66 62064 4517 110522652
Diarrhoea 149.82 19.61 257 61873 1139248 109387921
Blood pressure increased 149.11 19.61 398 61732 257975 110269194
Jaundice cholestatic 148.37 19.61 96 62034 14512 110512657
Nasal obstruction 146.17 19.61 59 62071 3291 110523878
Eosinophil count abnormal 136.82 19.61 42 62088 1032 110526137
Benign prostatic hyperplasia 135.88 19.61 99 62031 18135 110509034
Neutropenia 134.64 19.61 24 62106 374596 110152573
Lung neoplasm malignant 133.29 19.61 127 62003 33715 110493454
Pulmonary alveolar haemorrhage 129.24 19.61 100 62030 20050 110507119
Antineutrophil cytoplasmic antibody positive 128.72 19.61 61 62069 5015 110522154
Thrombocytopenia 128.35 19.61 21 62109 348864 110178305
Blood test abnormal 127.64 19.61 115 62015 28439 110498730
Lung diffusion test abnormal 127.31 19.61 32 62098 363 110526806
Superinfection 127.27 19.61 63 62067 5700 110521469
Secretion discharge 126.66 19.61 99 62031 20145 110507024
Atopy 125.55 19.61 40 62090 1114 110526055
Rash 125.27 19.61 167 61963 820797 109706372
Seasonal allergy 124.59 19.61 97 62033 19625 110507544
Glaucoma 123.62 19.61 102 62028 22415 110504754
Off label use 122.80 19.61 433 61697 1499752 109027417
Respiratory tract congestion 121.91 19.61 116 62014 30741 110496428
Bronchospasm 120.08 19.61 114 62016 30125 110497044
Sputum purulent 117.05 19.61 43 62087 1855 110525314
Pulmonary function test abnormal 114.41 19.61 56 62074 4944 110522225
Schizophrenia 113.87 19.61 96 62034 21730 110505439
Bronchial neoplasm 112.97 19.61 31 62099 505 110526664
Pneumonia 112.96 19.61 860 61270 875854 109651315
Confusional state 111.97 19.61 62 62068 468618 110058551
Death 111.91 19.61 137 61993 698732 109828437
Bronchitis 109.48 19.61 260 61870 156772 110370397
Hand deformity 108.74 19.61 3 62127 218503 110308666
Arthropathy 108.71 19.61 16 62114 287506 110239663
Central nervous system mass 107.88 19.61 33 62097 801 110526368
Viral infection 107.85 19.61 141 61989 52998 110474171
Wall motion score index abnormal 107.61 19.61 33 62097 808 110526361
Nasal turbinate hypertrophy 107.49 19.61 33 62097 811 110526358
Respiratory disorder 105.80 19.61 163 61967 71219 110455950
Dysphonia 105.07 19.61 168 61962 75761 110451408
Haemoptysis 104.45 19.61 162 61968 71192 110455977
Soft tissue disorder 103.85 19.61 47 62083 3477 110523692
Sinus pain 103.01 19.61 55 62075 5824 110521345
Sinus operation 101.36 19.61 44 62086 2947 110524222
Body temperature decreased 101.04 19.61 114 62016 36821 110490348
Glossodynia 100.63 19.61 6 62124 221998 110305171
Chronic sinusitis 100.43 19.61 95 62035 24989 110502180
Sleep apnoea syndrome 99.18 19.61 118 62012 40329 110486840
Nicotine dependence 96.54 19.61 34 62096 1297 110525872
Disease progression 96.00 19.61 12 62118 244022 110283147
Endometrial ablation 95.52 19.61 31 62099 917 110526252
Bronchial disorder 94.61 19.61 41 62089 2735 110524434
Cardiac septal defect 94.48 19.61 31 62099 950 110526219
Intentional product use issue 93.24 19.61 14 62116 247892 110279277
Emphysema 93.13 19.61 82 62048 19674 110507495
Crepitations 92.69 19.61 64 62066 10771 110516398
Decreased activity 91.95 19.61 64 62066 10910 110516259
Platelet count decreased 91.46 19.61 11 62119 230432 110296737
Contraindicated product administered 91.16 19.61 15 62115 248252 110278917
Hypothyroidism 91.03 19.61 154 61976 72745 110454424
Treatment failure 90.84 19.61 22 62108 277212 110249957
Nasopharyngitis 90.84 19.61 450 61680 393911 110133258
Rales 90.20 19.61 89 62041 24650 110502519
Hypoventilation 89.26 19.61 56 62074 8025 110519144
Vasculitis 88.52 19.61 105 62025 35768 110491401
Hyper IgE syndrome 88.32 19.61 27 62103 654 110526515
Scoliosis 87.72 19.61 57 62073 8676 110518493
Bronchial haemorrhage 87.67 19.61 32 62098 1355 110525814
Impaired healing 87.13 19.61 6 62124 196711 110330458
Hypoxia 86.56 19.61 211 61919 129304 110397865
Psychotic disorder 86.51 19.61 124 62006 50813 110476356
Transient ischaemic attack 86.38 19.61 140 61990 63842 110463327
White blood cell count decreased 86.16 19.61 13 62117 229377 110297792
Reversible airways obstruction 85.46 19.61 37 62093 2462 110524707
Helicobacter infection 85.30 19.61 4 62126 181873 110345296
Psoriatic arthropathy 84.31 19.61 7 62123 196754 110330415
Overdose 83.91 19.61 15 62115 233779 110293390
Respiratory rate increased 83.69 19.61 86 62044 24997 110502172
Vocal cord dysfunction 83.42 19.61 28 62102 922 110526247
Cryopyrin associated periodic syndrome 81.99 19.61 25 62105 600 110526569
Rhonchi 81.23 19.61 43 62087 4475 110522694
Pancytopenia 80.78 19.61 11 62119 209602 110317567
Sputum increased 79.42 19.61 46 62084 5705 110521464
Micturition urgency 78.93 19.61 74 62056 19246 110507923
Blister 78.60 19.61 16 62114 227360 110299809
Eosinophilic myocarditis 78.35 19.61 33 62097 2052 110525117
Malignant neoplasm progression 78.26 19.61 5 62125 174562 110352607
Capillaritis 76.57 19.61 34 62096 2405 110524764
Hypotension 75.34 19.61 111 62019 523738 110003431
Idiopathic intracranial hypertension 75.00 19.61 39 62091 3913 110523256
Allergy to animal 74.25 19.61 31 62099 1885 110525284
Febrile neutropenia 74.03 19.61 43 62087 316724 110210445
Oropharyngeal pain 72.57 19.61 203 61927 135073 110392096
Broncholithiasis 71.46 19.61 19 62111 273 110526896
Neuropathy peripheral 70.05 19.61 9 62121 179268 110347901
Throat clearing 68.87 19.61 38 62092 4295 110522874
Therapeutic product effect decreased 68.10 19.61 26 62104 244290 110282879
Atelectasis 67.73 19.61 93 62037 36619 110490550
Eosinophilic pneumonia 67.32 19.61 45 62085 7182 110519987
Irritable bowel syndrome 67.27 19.61 7 62123 164208 110362961
Rhinorrhoea 67.25 19.61 166 61964 102500 110424669
Microangiopathy 67.15 19.61 33 62097 2939 110524230
Sensitivity to weather change 67.01 19.61 51 62079 9977 110517192
Peak expiratory flow rate decreased 66.93 19.61 22 62108 678 110526491
Nonspecific reaction 66.09 19.61 33 62097 3041 110524128
Dehydration 65.23 19.61 38 62092 279473 110247696
Sepsis 65.11 19.61 53 62077 327293 110199876
Kyphosis 64.96 19.61 33 62097 3154 110524015
Hyponatraemia 64.36 19.61 21 62109 217632 110309537
Rheumatoid arthritis 64.08 19.61 45 62085 299568 110227601
Ventricular failure 63.61 19.61 20 62110 533 110526636
Forced vital capacity decreased 63.57 19.61 28 62102 1942 110525227
Blood creatinine increased 62.94 19.61 13 62117 182876 110344293
Lung consolidation 62.88 19.61 50 62080 10426 110516743
Hypokalaemia 62.72 19.61 13 62117 182435 110344734
Decreased appetite 62.57 19.61 107 62023 475739 110051430
Lymph node calcification 62.55 19.61 19 62111 450 110526719
Muscle tension dysphonia 62.06 19.61 17 62113 275 110526894
Sinus disorder 62.03 19.61 84 62046 32644 110494525
Nausea 61.76 19.61 424 61706 1235266 109291903
Joint injury 61.61 19.61 93 62037 39901 110487268
Anaemia 61.53 19.61 135 61995 546951 109980218
Rib deformity 61.10 19.61 16 62114 216 110526953
Increased bronchial secretion 61.04 19.61 34 62096 3914 110523255
Gastrointestinal haemorrhage 60.75 19.61 10 62120 165508 110361661
Pulmonary mass 60.71 19.61 89 62041 37212 110489957
Drug abuse 60.25 19.61 13 62117 177398 110349771
Bronchial obstruction 60.20 19.61 31 62099 3048 110524121
Inflammation 60.11 19.61 17 62113 193221 110333948
CFTR gene mutation 59.97 19.61 16 62114 233 110526936
Alanine aminotransferase increased 59.37 19.61 15 62115 183758 110343411
Eosinophil count 59.21 19.61 15 62115 176 110526993
Mycobacterium avium complex infection 58.15 19.61 38 62092 5839 110521330
Cardiac arrest 58.15 19.61 19 62111 196734 110330435
Respiratory tract infection 58.13 19.61 126 62004 71491 110455678
Aspartate aminotransferase increased 55.80 19.61 11 62119 159925 110367244
Coronary artery disease 55.77 19.61 124 62006 71566 110455603
Secondary immunodeficiency 55.69 19.61 34 62096 4642 110522527
Eosinophilic pneumonia chronic 54.94 19.61 18 62112 549 110526620
Sinusitis 54.93 19.61 319 61811 296369 110230800
Blood pressure systolic increased 54.15 19.61 134 61996 82857 110444312
Abdominal discomfort 53.21 19.61 87 62043 393771 110133398
Joint range of motion decreased 53.12 19.61 4 62126 121828 110405341
Injury 52.59 19.61 17 62113 177248 110349921
Eosinophil count decreased 52.54 19.61 36 62094 5982 110521187
Asthmatic crisis 52.05 19.61 25 62105 2117 110525052
Exposure to allergen 50.99 19.61 17 62113 548 110526621
Septic shock 50.61 19.61 13 62117 157515 110369654
Therapy non-responder 50.51 19.61 13 62117 157294 110369875
Musculoskeletal stiffness 50.02 19.61 50 62080 279772 110247397
Haemoglobin decreased 49.78 19.61 40 62090 248687 110278482
Weight decreased 49.20 19.61 439 61691 467618 110059551
Intentional product misuse 48.83 19.61 8 62122 132896 110394273
Alopecia 47.94 19.61 82 62048 364671 110162498
Anxiety 47.90 19.61 345 61785 344733 110182436
Renal impairment 47.81 19.61 23 62107 188422 110338747
Stomatitis 47.50 19.61 49 62081 270193 110256976
Cholelithiasis 47.44 19.61 108 62022 63314 110463855
Sleep disorder due to general medical condition, insomnia type 47.42 19.61 3 62127 105640 110421529
Vomiting 47.14 19.61 309 61821 910366 109616803
Herpes zoster 47.10 19.61 151 61979 108228 110418941
Rib fracture 47.09 19.61 75 62055 33695 110493474
Drug-induced liver injury 46.97 19.61 6 62124 120061 110407108
Fibromuscular dysplasia 46.94 19.61 14 62116 311 110526858
Suffocation feeling 46.59 19.61 23 62107 2068 110525101
Arthritis 46.45 19.61 202 61928 167384 110359785
Multiple organ dysfunction syndrome 45.98 19.61 14 62116 151696 110375473
Thrombosis 45.96 19.61 150 61980 108512 110418657
Inspiratory capacity abnormal 45.77 19.61 11 62119 102 110527067
Eczema 45.35 19.61 115 62015 72178 110454991
Neutrophil count decreased 45.07 19.61 7 62123 120934 110406235
Seizure 44.98 19.61 35 62095 221150 110306019
Constipation 44.71 19.61 83 62047 357703 110169466
Lung disorder 44.65 19.61 210 61920 179837 110347332
Abdominal pain upper 44.50 19.61 80 62050 349031 110178138
Respiratory tract inflammation 44.24 19.61 18 62112 1025 110526144
Hyperkalaemia 44.02 19.61 11 62119 135785 110391384
Depressed level of consciousness 42.99 19.61 6 62124 112272 110414897
Polycystic ovaries 42.61 19.61 29 62101 4767 110522402
Swelling 42.49 19.61 83 62047 350958 110176211
Fear of disease 42.36 19.61 19 62111 1376 110525793
Malaise 41.47 19.61 567 61563 671252 109855917
Neurosensory hypoacusis 41.19 19.61 12 62118 245 110526924
Eye allergy 40.59 19.61 17 62113 1042 110526127
Deep vein thrombosis 40.47 19.61 14 62116 139873 110387296
Lower respiratory tract infection 40.28 19.61 254 61876 242852 110284317
Liver disorder 39.85 19.61 15 62115 142228 110384941
Diaphragmatic disorder 39.82 19.61 20 62110 1866 110525303
Medication error 39.48 19.61 6 62124 105360 110421809
Pulmonary congestion 39.42 19.61 66 62064 30900 110496269
Bursitis 39.35 19.61 12 62118 129906 110397263
Coma 39.28 19.61 9 62121 117860 110409309
Cardiac failure 39.03 19.61 29 62101 187597 110339572
Maternal exposure during pregnancy 38.59 19.61 52 62078 254831 110272338
Musculoskeletal pain 38.45 19.61 28 62102 182995 110344174
Blood immunoglobulin E decreased 38.06 19.61 11 62119 218 110526951
Lactic acidosis 37.89 19.61 4 62126 92807 110434362
Prescribed overdose 37.83 19.61 3 62127 87578 110439591
Eye disorder 37.32 19.61 62 62068 28844 110498325
Muscular weakness 37.30 19.61 51 62079 248417 110278752
Humidity intolerance 37.13 19.61 13 62117 487 110526682
Oesophageal polyp 36.74 19.61 9 62121 91 110527078
Venous pressure jugular increased 36.60 19.61 17 62113 1335 110525834
Affective disorder 36.52 19.61 38 62092 11203 110515966
Ankle fracture 36.25 19.61 50 62080 19769 110507400
Stress 35.55 19.61 135 61995 105213 110421956
Skin lesion 35.42 19.61 85 62045 51546 110475623
Tympanosclerosis 35.28 19.61 8 62122 56 110527113
Eosinophilic bronchitis 35.12 19.61 13 62117 573 110526596
Bradycardia 35.07 19.61 22 62108 155495 110371674
Allergic sinusitis 35.02 19.61 18 62112 1763 110525406
Limb injury 34.96 19.61 70 62060 37566 110489603
Nasal discharge discolouration 34.89 19.61 22 62108 3179 110523990
Hepatotoxicity 34.83 19.61 96 62034 63304 110463865
Epilepsy 34.73 19.61 7 62123 100202 110426967
Mobility decreased 34.38 19.61 50 62080 237372 110289797
Granuloma 34.33 19.61 34 62096 9456 110517713
Wound 34.31 19.61 49 62081 234388 110292781
Hepatitis 34.04 19.61 5 62125 90049 110437120
Lip pruritus 33.87 19.61 16 62114 1306 110525863
Renal failure 33.52 19.61 47 62083 226527 110300642
Asthenia 33.51 19.61 238 61892 688761 109838408
C-reactive protein increased 33.45 19.61 44 62086 217875 110309294
Hypoaesthesia 33.29 19.61 80 62050 314143 110213026
Rhabdomyolysis 33.23 19.61 13 62117 120388 110406781
Urinary tract infection 33.06 19.61 85 62045 326197 110200972
Cognitive disorder 32.75 19.61 5 62125 87506 110439663
Product use in unapproved indication 32.54 19.61 135 61995 447242 110079927
Infective exacerbation of chronic obstructive airways disease 32.48 19.61 21 62109 3169 110524000
Vital capacity decreased 32.45 19.61 18 62112 2055 110525114
Dry mouth 32.12 19.61 39 62091 199909 110327260
Muscle spasms 31.75 19.61 68 62062 278089 110249080
Pancreatitis relapsing 31.62 19.61 16 62114 1516 110525653
Sneezing 31.54 19.61 61 62069 31923 110495246
Hepatic function abnormal 31.44 19.61 6 62124 89289 110437880
Lower limb fracture 31.40 19.61 3 62127 75345 110451824
Throat irritation 31.34 19.61 83 62047 53469 110473700
Lower respiratory tract congestion 31.18 19.61 24 62106 4772 110522397
Ascites 31.10 19.61 7 62123 92801 110434368
Frustration tolerance decreased 31.07 19.61 31 62099 8700 110518469
Pneumonitis 30.89 19.61 104 62026 76427 110450742
Forced expiratory flow decreased 30.68 19.61 10 62120 300 110526869
General physical health deterioration 30.52 19.61 129 62001 425166 110102003
Choking 30.50 19.61 40 62090 15070 110512099
Vascular shunt 30.39 19.61 7 62123 53 110527116
Pleural effusion 30.34 19.61 33 62097 177676 110349493
Oropharyngeal discomfort 30.17 19.61 33 62097 10294 110516875
Obstruction 29.38 19.61 25 62105 5727 110521442
Wound infection 29.05 19.61 9 62121 96456 110430713
Liver function test increased 29.03 19.61 7 62123 88541 110438628
Myalgia 28.93 19.61 219 61911 222162 110305007
Rectal prolapse 28.91 19.61 18 62112 2545 110524624
Respiratory failure 28.65 19.61 48 62082 215284 110311885
Nocturnal dyspnoea 28.58 19.61 16 62114 1859 110525310
Nasal mucosal disorder 28.52 19.61 16 62114 1867 110525302
Live birth 28.35 19.61 3 62127 69481 110457688
Chest X-ray abnormal 28.13 19.61 29 62101 8458 110518711
Ventricular hypokinesia 27.95 19.61 33 62097 11181 110515988
Angioplasty 27.84 19.61 16 62114 1955 110525214
Gastrointestinal disorder 27.74 19.61 59 62071 241893 110285276
Polyp 27.62 19.61 31 62099 9949 110517220
Psoriasis 27.40 19.61 23 62107 139970 110387199
Synovitis 27.31 19.61 72 62058 274020 110253149
Blood bilirubin increased 27.00 19.61 99 62031 75873 110451296
FEV1/FVC ratio decreased 26.91 19.61 9 62121 293 110526876
Loss of consciousness 26.82 19.61 43 62087 196263 110330906
Somnolence 26.79 19.61 82 62048 297367 110229802
Electrocardiogram QT prolonged 26.58 19.61 14 62116 108946 110418223
Exposure during pregnancy 26.53 19.61 33 62097 167391 110359778
Forearm fracture 26.52 19.61 11 62119 658 110526511
Sinus congestion 26.34 19.61 55 62075 30404 110496765
Autoimmune disorder 26.28 19.61 3 62127 65480 110461689
Suicidal ideation 26.16 19.61 10 62120 93927 110433242
Red blood cell sedimentation rate increased 26.05 19.61 6 62124 78296 110448873
Animal scratch 26.02 19.61 15 62115 1844 110525325
Peak expiratory flow rate abnormal 25.80 19.61 7 62123 109 110527060
Pneumonia aspiration 25.53 19.61 7 62123 81226 110445943
Terminal insomnia 25.44 19.61 15 62115 1923 110525246
Delirium 25.43 19.61 23 62107 135002 110392167
Unresponsive to stimuli 25.41 19.61 3 62127 63787 110463382
Lipohypertrophy 25.23 19.61 12 62118 994 110526175
Transaminases increased 25.20 19.61 3 62127 63387 110463782
Adverse event 25.07 19.61 15 62115 108794 110418375
Aplastic anaemia 24.75 19.61 47 62083 24261 110502908
Croup infectious 24.74 19.61 12 62118 1038 110526131
Respiration abnormal 24.67 19.61 29 62101 9780 110517389
Breast neoplasm 24.66 19.61 12 62118 1046 110526123
Lacrimation increased 24.59 19.61 54 62076 30896 110496273
International normalised ratio increased 24.56 19.61 9 62121 86763 110440406
Immunisation reaction 24.51 19.61 11 62119 798 110526371
Joint warmth 24.44 19.61 15 62115 2067 110525102
Ligament pain 24.36 19.61 8 62122 246 110526923
Agitation 24.12 19.61 17 62113 113034 110414135
Metabolic acidosis 24.06 19.61 13 62117 99731 110427438
Joint swelling 24.00 19.61 148 61982 442697 110084472
Osteopenia 23.94 19.61 44 62086 22165 110505004
Amnesia 23.64 19.61 15 62115 105393 110421776
Lung hyperinflation 23.50 19.61 15 62115 2214 110524955
Neoplasm progression 23.48 19.61 4 62126 64591 110462578
Melaena 23.42 19.61 5 62125 68752 110458417
Dry skin 23.22 19.61 16 62114 107637 110419532
Fluid retention 23.18 19.61 12 62118 94295 110432874
Mycobacterium tuberculosis complex test positive 22.58 19.61 17 62113 3271 110523898
Blood alkaline phosphatase increased 22.50 19.61 6 62124 70929 110456240
Hypohidrosis 22.40 19.61 8 62122 318 110526851
Ischaemic cardiomyopathy 22.37 19.61 25 62105 7986 110519183
C-reactive protein abnormal 22.23 19.61 24 62106 129671 110397498
Abdominal pain 22.18 19.61 183 61947 512806 110014363
Pleural thickening 22.08 19.61 17 62113 3382 110523787
Blood creatine phosphokinase increased 21.68 19.61 7 62123 73070 110454099
Granulomatosis with polyangiitis 21.68 19.61 17 62113 3473 110523696
Hepatic failure 21.46 19.61 6 62124 68733 110458436
Aphonia 21.38 19.61 31 62099 12829 110514340
Panic reaction 21.00 19.61 20 62110 5302 110521867
Hypersensitivity 20.94 19.61 331 61799 403667 110123502
Skin ulcer 20.93 19.61 5 62125 63640 110463529
Serotonin syndrome 20.77 19.61 4 62126 59149 110468020
Hyperglycaemia 20.65 19.61 11 62119 85079 110442090
Arthralgia 20.64 19.61 311 61819 779321 109747848
Pyrexia 20.59 19.61 368 61762 897897 109629272
Blood immunoglobulin E 20.56 19.61 5 62125 49 110527120
Haemorrhage 20.55 19.61 116 62014 106576 110420593
Condition aggravated 20.48 19.61 549 61581 734287 109792882
Eye pruritus 20.41 19.61 52 62078 32723 110494446
Product quality issue 20.27 19.61 9 62121 77290 110449879
Shock 20.19 19.61 3 62127 53585 110473584
Discomfort 20.19 19.61 58 62072 214649 110312520
Oesophagogastroduodenoscopy 20.18 19.61 7 62123 255 110526914
Stridor 20.09 19.61 22 62108 6873 110520296
Altered state of consciousness 20.02 19.61 4 62126 57622 110469547
Cardiogenic shock 19.88 19.61 4 62126 57334 110469835
Lymphocyte count decreased 19.83 19.61 4 62126 57239 110469930
Prescribed underdose 19.77 19.61 6 62124 65168 110462001

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 D005938 Glucocorticoids
MeSH PA D006728 Hormones
MeSH PA D018926 Anti-Allergic Agents
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:50857 anti-allergic agent
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:77715 nasal decongestant

Related Drugs by ATC class:

R01AD Corticosteroids 12 drugs
beclometasone dipropionatebetamethasonebudesonidedexamethasoneflunisolidefluticasone furoatefluticasone propionatehydrocortisonemometasone furoateprednisolonetixocortoltriamcinolone
R03BA Glucocorticoids 8 drugs
beclometasone dipropionatebetamethasonebudesonideflunisolidefluticasone furoatefluticasone propionatemometasone furoatetriamcinolone

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 AZURITY 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 AZURITY 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 AZURITY 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 AZURITY N202129 Jan. 20, 2012 DISCN 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
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
4027427 VANDF
S59502J185 INXIGHT DRUGS

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
Alvesco HUMAN PRESCRIPTION DRUG LABEL 1 70515-711 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 27 sections
Alvesco HUMAN PRESCRIPTION DRUG LABEL 1 70515-712 AEROSOL, METERED 160 ug RESPIRATORY (INHALATION) NDA 27 sections