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

Stem definitionDrug idCAS RN
prednisone and prednisolone derivatives 1832 83919-23-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • mometasone furoate hydrate
  • mometasone furoate
  • asmanex
  • ecural
  • elomet
  • nasonex
  • mometasone furoate monohydrate
A pregnadienediol derivative ANTI-ALLERGIC AGENT and ANTI-INFLAMMATORY AGENT that is used in the management of ASTHMA and ALLERGIC RHINITIS. It is also used as a topical treatment for skin disorders.
  • Molecular weight: 521.43
  • Formula: C27H30Cl2O6
  • CLOGP: 4.12
  • LIPINSKI: 1
  • HAC: 6
  • HDO: 1
  • TPSA: 93.81
  • ALOGS: -4.68
  • ROTB: 5

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.20 mg N
0.40 mg Inhal.powder

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.02 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 2.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 12.70 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) 4.40 hours Lombardo F, Berellini G, Obach RS
BA (Bioavailability) 0.00 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K
BA (Bioavailability) 0.01 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

DateAgencyCompanyOrphan
April 30, 1987 FDA MERCK SHARP DOHME
June 29, 2020 PMDA Novartis Pharma K.K.
May 30, 2020 EMA Novartis Europharm Limited

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Product quality issue 4905.95 11.49 1780 74525 34085 63378632
No adverse event 2975.56 11.49 1292 75013 40113 63372604
Poor quality device used 2499.22 11.49 564 75741 1507 63411210
Product dose omission issue 1860.33 11.49 1813 74492 232500 63180217
Asthma 716.31 11.49 823 75482 126738 63285979
Product container issue 623.33 11.49 181 76124 1612 63411105
Gastrooesophageal reflux disease 563.62 11.49 633 75672 95006 63317711
Device malfunction 558.60 11.49 317 75988 17540 63395177
Wheezing 511.52 11.49 602 75703 94993 63317724
Rhinitis allergic 396.15 11.49 219 76086 11508 63401209
Circumstance or information capable of leading to medication error 375.82 11.49 150 76155 3720 63408997
Ejection fraction 326.34 11.49 119 76186 2287 63410430
Sleep disorder due to a general medical condition 324.65 11.49 195 76110 11993 63400724
Sensitisation 310.70 11.49 126 76179 3260 63409457
Sputum discoloured 300.32 11.49 207 76098 16140 63396577
Polycystic ovaries 292.85 11.49 131 76174 4340 63408377
Cough 268.51 11.49 867 75438 291876 63120841
Sleep apnoea syndrome 243.88 11.49 233 76072 28900 63383817
Blood test abnormal 243.49 11.49 179 76126 15450 63397267
Nasal polyps 232.45 11.49 123 76182 5916 63406801
Productive cough 225.23 11.49 326 75979 62882 63349835
Dyspnoea 203.22 11.49 1423 74882 659890 62752827
Synovitis 197.23 11.49 6 76299 186912 63225805
Full blood count abnormal 195.26 11.49 215 76090 31502 63381215
Glossodynia 174.58 11.49 10 76295 178866 63233851
Obstructive airways disorder 174.08 11.49 166 76139 20533 63392184
Contraindicated product administered 173.63 11.49 27 76278 217621 63195096
Toxicity to various agents 165.76 11.49 46 76259 247204 63165513
Hand deformity 165.09 11.49 6 76299 159451 63253266
Systemic lupus erythematosus 164.21 11.49 27 76278 208891 63203826
Pneumonia aspiration 157.72 11.49 201 76104 34339 63378378
Incorrect dose administered 154.98 11.49 267 76038 59701 63353016
Nasal congestion 146.23 11.49 274 76031 65386 63347331
Bronchiectasis 136.77 11.49 130 76175 16012 63396705
Presbyacusis 135.34 11.49 67 76238 2798 63409919
Infective pulmonary exacerbation of cystic fibrosis 135.11 11.49 100 76205 8717 63404000
Death 132.49 11.49 153 76152 374228 63038489
Carpal tunnel syndrome 131.39 11.49 143 76162 20674 63392043
Pericarditis 129.47 11.49 7 76298 131572 63281145
Steroid withdrawal syndrome 129.27 11.49 41 76264 504 63412213
Pleural fibrosis 128.78 11.49 69 76236 3403 63409314
Asthma-chronic obstructive pulmonary disease overlap syndrome 127.39 11.49 58 76247 2003 63410714
Wound 126.28 11.49 22 76283 163241 63249476
Pleural thickening 120.32 11.49 62 76243 2821 63409896
Burning sensation 114.90 11.49 222 76083 54185 63358532
Chest discomfort 113.71 11.49 340 75965 109629 63303088
Deafness neurosensory 112.28 11.49 71 76234 4784 63407933
Total lung capacity increased 112.04 11.49 55 76250 2255 63410462
Blood magnesium increased 111.63 11.49 60 76245 2978 63409739
Bronchopulmonary aspergillosis allergic 110.23 11.49 54 76251 2204 63410513
Maternal exposure during pregnancy 109.94 11.49 64 76241 219998 63192719
Alopecia 107.87 11.49 149 76156 337387 63075330
Abdominal discomfort 104.19 11.49 140 76165 320745 63091972
Ejection fraction abnormal 103.34 11.49 48 76257 1737 63410980
Off label use 101.45 11.49 442 75863 674020 62738697
Acute kidney injury 99.36 11.49 102 76203 263313 63149404
Neutropenia 97.68 11.49 44 76261 174961 63237756
Nephrectomy 94.99 11.49 43 76262 1465 63411252
Sinusitis 94.27 11.49 528 75777 226125 63186592
Joint swelling 93.72 11.49 156 76149 327510 63085207
Underdose 92.52 11.49 138 76167 27318 63385399
Helicobacter infection 91.07 11.49 5 76300 92780 63319937
Rheumatoid factor positive 87.95 11.49 3 76302 84403 63328314
Swelling 87.50 11.49 122 76183 275256 63137461
Arthropathy 87.31 11.49 92 76213 234700 63178017
Therapeutic product effect incomplete 86.45 11.49 338 75967 124718 63287999
Epigastric discomfort 84.45 11.49 68 76237 6712 63406005
Rales 81.48 11.49 88 76217 12609 63400108
Sinus disorder 80.72 11.49 122 76183 24431 63388286
Infusion related reaction 79.77 11.49 107 76198 245414 63167303
Cardiac disorder 77.90 11.49 182 76123 50634 63362083
Cyst 75.60 11.49 89 76216 14010 63398707
Hypothyroidism 74.65 11.49 161 76144 42471 63370246
Thrombocytopenia 73.99 11.49 45 76260 151112 63261605
General physical health deterioration 72.56 11.49 81 76224 201321 63211396
Asthma exercise induced 71.62 11.49 23 76282 295 63412422
Sarcoidosis 71.33 11.49 63 76242 7059 63405658
Drug abuse 70.88 11.49 4 76301 72514 63340203
Lung opacity 69.96 11.49 45 76260 3123 63409594
Intentional overdose 69.76 11.49 5 76300 74147 63338570
Product taste abnormal 68.14 11.49 38 76267 2029 63410688
Coma 67.43 11.49 200 76105 64164 63348553
Rhinitis 66.41 11.49 75 76230 11291 63401426
Factor V Leiden mutation 65.82 11.49 20 76285 211 63412506
Bone cyst 65.08 11.49 38 76267 2216 63410501
Renal disorder 64.12 11.49 130 76175 32844 63379873
Osteopenia 61.79 11.49 96 76209 19689 63393028
Discomfort 60.62 11.49 67 76238 167307 63245410
Vomiting 60.60 11.49 409 75896 559208 62853509
Confusional state 60.00 11.49 121 76184 236259 63176458
Nasal discomfort 59.83 11.49 48 76257 4712 63408005
Dysphonia 59.76 11.49 158 76147 47456 63365261
Anosmia 59.54 11.49 56 76249 6804 63405913
Headache 57.98 11.49 1075 75230 632166 62780551
Therapeutic product effect decreased 57.02 11.49 90 76215 193097 63219620
Overdose 56.67 11.49 34 76271 115044 63297673
Anaemia 56.66 11.49 173 76132 293257 63119460
Drug interaction 55.86 11.49 120 76185 229011 63183706
Folliculitis 55.39 11.49 9 76296 70308 63342409
Impaired healing 55.31 11.49 27 76278 102515 63310202
Rhinorrhoea 55.20 11.49 189 76116 65388 63347329
Upper-airway cough syndrome 54.57 11.49 68 76237 11350 63401367
Bronchitis 54.51 11.49 295 76010 124640 63288077
Loss of personal independence in daily activities 54.00 11.49 246 76059 97044 63315673
Wrong technique in device usage process 53.32 11.49 40 76265 3558 63409159
Prolonged expiration 52.87 11.49 26 76279 1070 63411647
Heart sounds 52.18 11.49 25 76280 971 63411746
Urinary tract discomfort 51.90 11.49 22 76283 638 63412079
Total lung capacity decreased 50.67 11.49 32 76273 2151 63410566
Leukopenia 50.58 11.49 15 76290 77275 63335442
Middle insomnia 49.11 11.49 68 76237 12575 63400142
Poor quality product administered 48.81 11.49 36 76269 3120 63409597
Pancytopenia 48.63 11.49 28 76277 96905 63315812
Hypotension 48.26 11.49 167 76138 272437 63140280
Dermatitis atopic 48.23 11.49 59 76246 9665 63403052
Chronic obstructive pulmonary disease 47.05 11.49 174 76131 62512 63350205
Sinus pain 46.33 11.49 36 76269 3374 63409343
Osteosclerosis 46.32 11.49 38 76267 3850 63408867
Occupational asthma 46.22 11.49 14 76291 146 63412571
Dry eye 45.90 11.49 130 76175 40631 63372086
Alveolar osteitis 45.34 11.49 22 76283 879 63411838
Multiple organ dysfunction syndrome 45.30 11.49 7 76298 56745 63355972
Oropharyngeal pain 45.27 11.49 229 76076 94258 63318459
Bronchial obstruction 45.08 11.49 26 76279 1481 63411236
Cardiac arrest 44.65 11.49 28 76277 92517 63320200
Tunnel vision 44.63 11.49 24 76281 1192 63411525
Irritable bowel syndrome 43.99 11.49 22 76283 82390 63330327
Forced expiratory volume decreased 43.97 11.49 41 76264 4927 63407790
Febrile neutropenia 43.33 11.49 47 76258 118402 63294315
Cardiac murmur 43.21 11.49 69 76236 14483 63398234
Diarrhoea 42.94 11.49 604 75701 714762 62697955
Hepatic enzyme increased 42.92 11.49 114 76191 202214 63210503
Pain 41.78 11.49 633 75672 739995 62672722
Platelet count decreased 41.47 11.49 47 76258 116075 63296642
Hyponatraemia 41.38 11.49 44 76261 111856 63300861
Intentional product use issue 41.23 11.49 56 76249 127836 63284881
Animal scratch 41.19 11.49 24 76281 1394 63411323
Condition aggravated 40.99 11.49 299 76006 401918 63010799
Liver injury 40.98 11.49 11 76294 60509 63352208
Eosinophilic granulomatosis with polyangiitis 40.82 11.49 28 76277 2164 63410553
Product odour abnormal 40.48 11.49 23 76282 1273 63411444
Hyperkalaemia 38.35 11.49 9 76296 54194 63358523
Disease progression 37.34 11.49 56 76249 122702 63290015
Somnolence 37.31 11.49 353 75952 178332 63234385
Metabolic acidosis 37.27 11.49 5 76300 45064 63367653
Oesophageal dilatation 37.05 11.49 15 76290 386 63412331
Asthenopia 36.92 11.49 27 76278 2310 63410407
Dehydration 36.51 11.49 98 76207 173256 63239461
Swelling face 36.34 11.49 162 76143 63313 63349404
Sleep disorder 35.83 11.49 193 76112 81373 63331344
C-reactive protein increased 35.29 11.49 37 76268 94670 63318047
Respiration abnormal 35.22 11.49 41 76264 6376 63406341
Therapy non-responder 35.21 11.49 24 76281 75877 63336840
Ear congestion 35.06 11.49 28 76277 2731 63409986
Mucosal inflammation 34.81 11.49 7 76298 46921 63365796
Swollen tongue 34.43 11.49 106 76199 34694 63378023
Respiratory tract congestion 34.30 11.49 70 76235 17762 63394955
Exposure during pregnancy 34.24 11.49 86 76219 155461 63257256
Drug intolerance 33.61 11.49 225 76080 308436 63104281
Cardio-respiratory arrest 33.54 11.49 15 76290 59944 63352773
Hip arthroplasty 33.53 11.49 8 76297 47638 63365079
Neutrophil count decreased 33.34 11.49 13 76292 56393 63356324
Eczema 32.54 11.49 99 76206 32192 63380525
Palpitations 32.18 11.49 239 76066 112531 63300186
Seasonal allergy 32.06 11.49 75 76230 20875 63391842
Upper respiratory tract infection 31.97 11.49 188 76117 81859 63330858
Nasal mucosal disorder 31.54 11.49 14 76291 455 63412262
Expired product administered 31.46 11.49 38 76267 6143 63406574
White blood cell count decreased 31.32 11.49 76 76229 139028 63273689
Paranasal sinus discomfort 31.05 11.49 32 76273 4344 63408373
Circumstance or information capable of leading to device use error 31.02 11.49 10 76295 130 63412587
Incorrect dose administered by product 30.98 11.49 11 76294 195 63412522
Bladder pain 30.56 11.49 24 76281 2284 63410433
Drug ineffective 30.56 11.49 991 75314 1043774 62368943
Decreased appetite 30.42 11.49 177 76128 250875 63161842
Lactic acidosis 29.93 11.49 5 76300 38282 63374435
Peripheral swelling 29.88 11.49 192 76113 265750 63146967
Skin lesion 29.86 11.49 93 76212 30628 63382089
Septic shock 29.68 11.49 22 76283 66607 63346110
Knee arthroplasty 29.64 11.49 14 76291 54192 63358525
Blood potassium increased 29.62 11.49 67 76238 18242 63394475
Inappropriate schedule of product administration 29.47 11.49 220 76085 103745 63308972
Hypomania 29.14 11.49 37 76268 6293 63406424
Pre-existing condition improved 28.58 11.49 42 76263 8202 63404515
Rheumatoid arthritis 28.13 11.49 184 76121 253635 63159082
Skin weeping 28.02 11.49 15 76290 738 63411979
Haemoptysis 27.95 11.49 87 76218 28639 63384078
Female sterilisation 27.92 11.49 14 76291 601 63412116
CFTR gene mutation 27.92 11.49 9 76296 117 63412600
Sepsis 27.61 11.49 93 76212 153030 63259687
Renal failure 27.51 11.49 63 76242 117589 63295128
Product use issue 26.97 11.49 155 76150 220365 63192352
Dyspnoea exertional 26.69 11.49 143 76162 60159 63352558
Epistaxis 26.65 11.49 164 76141 72561 63340156
Pulmonary function test decreased 26.46 11.49 28 76277 3919 63408798
Red blood cell sedimentation rate increased 26.22 11.49 10 76295 43972 63368745
Acquired haemophilia 26.17 11.49 16 76289 1015 63411702
Suicide attempt 26.01 11.49 21 76284 60897 63351820
Anxiety 25.93 11.49 386 75919 217155 63195562
Lung perforation 25.87 11.49 8 76297 90 63412627
Rash 25.82 11.49 497 75808 560374 62852343
Cholelithiasis 25.81 11.49 113 76192 43812 63368905
Interstitial lung disease 25.62 11.49 22 76283 61886 63350831
Blister 25.40 11.49 76 76229 129738 63282979
Throat irritation 25.37 11.49 101 76204 37546 63375171
Adrenal suppression 25.16 11.49 15 76290 909 63411808
Product quality control issue 25.14 11.49 6 76299 22 63412695
Jaundice cholestatic 24.94 11.49 37 76268 7287 63405430
Painful respiration 24.76 11.49 23 76282 2751 63409966
Blood calcium increased 24.62 11.49 42 76263 9308 63403409
Nasal disorder 24.13 11.49 23 76282 2841 63409876
Glaucoma 23.98 11.49 63 76242 18842 63393875
Treatment failure 23.75 11.49 141 76164 198902 63213815
Product availability issue 23.75 11.49 27 76278 4094 63408623
Electrocardiogram QT prolonged 23.62 11.49 22 76283 59508 63353209
Respiratory tract infection 23.08 11.49 105 76200 41378 63371339
Fibromyalgia 22.68 11.49 170 76135 80250 63332467
Exposure to allergen 22.67 11.49 10 76295 320 63412397
Encephalopathy 22.66 11.49 9 76296 38611 63374106
Sinus congestion 22.59 11.49 60 76245 18063 63394654
Pneumonia 22.55 11.49 713 75592 456054 62956663
Delirium 22.11 11.49 17 76288 50524 63362193
Ureteral disorder 21.97 11.49 10 76295 345 63412372
Diaphragmatic rupture 21.49 11.49 9 76296 253 63412464
Wound secretion 21.29 11.49 27 76278 4587 63408130
Skin fragility 20.96 11.49 12 76293 674 63412043
Malignant neoplasm progression 20.84 11.49 42 76263 82079 63330638
Vital capacity decreased 20.82 11.49 17 76288 1711 63411006
Croup infectious 20.65 11.49 11 76294 536 63412181
Obstruction 20.64 11.49 22 76283 3105 63409612
Hypophagia 20.57 11.49 6 76299 31253 63381464
Depressive symptom 20.52 11.49 25 76280 4077 63408640
Product dosage form issue 20.22 11.49 5 76300 22 63412695
Aspiration 20.17 11.49 42 76263 10809 63401908
Haemoglobin decreased 20.15 11.49 98 76207 145387 63267330
Adiposis dolorosa 19.95 11.49 9 76296 304 63412413
Fatigue 19.94 11.49 869 75436 887159 62525558
Arthralgia 19.91 11.49 527 75778 569183 62843534
Nasal dryness 19.87 11.49 26 76279 4555 63408162
International normalised ratio increased 19.82 11.49 16 76289 46409 63366308
Hepatic failure 19.82 11.49 9 76296 35647 63377070
Gastrointestinal haemorrhage 19.35 11.49 43 76262 81133 63331584
Enthesopathy 19.22 11.49 36 76269 8578 63404139
Perfume sensitivity 19.18 11.49 12 76293 793 63411924
Psoriatic arthropathy 19.06 11.49 52 76253 91468 63321249
Fall 18.85 11.49 345 75960 391989 63020728
Skin burning sensation 18.84 11.49 45 76260 12689 63400028
Polymyalgia rheumatica 18.80 11.49 23 76282 3768 63408949
Lung neoplasm malignant 18.68 11.49 59 76246 19574 63393143
Sneezing 18.49 11.49 56 76249 18162 63394555
Periodic limb movement disorder 18.43 11.49 8 76297 246 63412471
Prescribed overdose 18.40 11.49 9 76296 34144 63378573
Exposure to fungus 18.23 11.49 7 76298 156 63412561
Flail chest 18.20 11.49 6 76299 84 63412633
Illness 18.20 11.49 111 76194 48948 63363769
Migraine 18.11 11.49 197 76108 103149 63309568
Drug reaction with eosinophilia and systemic symptoms 18.10 11.49 9 76296 33827 63378890
Angioedema 18.10 11.49 109 76196 47856 63364861
Deformity 18.06 11.49 42 76263 11642 63401075
Hippocampal sclerosis 17.89 11.49 6 76299 89 63412628
Stomatitis 17.77 11.49 96 76209 138629 63274088
Increased upper airway secretion 17.76 11.49 22 76283 3650 63409067
Purpura senile 17.61 11.49 10 76295 553 63412164
Cardiac failure 17.57 11.49 52 76253 89090 63323627
Tarsal tunnel syndrome 17.43 11.49 10 76295 564 63412153
Wound complication 17.40 11.49 22 76283 3725 63408992
Eosinophil count abnormal 17.21 11.49 10 76295 578 63412139
Ulcer 17.20 11.49 5 76300 26102 63386615
Sedation 17.04 11.49 13 76292 38796 63373921
Drug-induced liver injury 17 11.49 14 76291 40208 63372509
Intentional self-injury 16.78 11.49 5 76300 25682 63387035
Schizophrenia 16.75 11.49 37 76268 9915 63402802
Live birth 16.72 11.49 5 76300 25625 63387092
Erythema marginatum 16.48 11.49 4 76301 16 63412701
Body temperature abnormal 16.46 11.49 16 76289 2025 63410692
Depressed level of consciousness 16.40 11.49 31 76274 62047 63350670
Shock 16.39 11.49 4 76301 23459 63389258
Nasal oedema 16.32 11.49 14 76291 1508 63411209
Bronchitis chronic 16.29 11.49 23 76282 4330 63408387
Product leakage 16.27 11.49 11 76294 830 63411887
Exercise tolerance decreased 16.23 11.49 26 76279 5471 63407246
Hypocalcaemia 16.13 11.49 9 76296 31704 63381013
Bronchial irritation 16.10 11.49 4 76301 18 63412699
Paranasal sinus inflammation 16.04 11.49 9 76296 486 63412231
Joint stiffness 16.00 11.49 16 76289 41853 63370864
Dystrophic calcification 15.87 11.49 6 76299 128 63412589
Cytomegalovirus infection 15.80 11.49 3 76302 20949 63391768
Accident 15.75 11.49 27 76278 6005 63406712
Post-traumatic stress disorder 15.73 11.49 25 76280 5226 63407491
Bradycardia 15.71 11.49 41 76264 73186 63339531
Sleep disorder due to general medical condition, insomnia type 15.70 11.49 24 76281 52193 63360524
Hypertension 15.65 11.49 443 75862 278860 63133857
Hepatic function abnormal 15.61 11.49 13 76292 37129 63375588
Anaphylactic reaction 15.52 11.49 134 76171 65966 63346751
Calculus urinary 15.39 11.49 13 76292 1371 63411346
Tongue pruritus 15.35 11.49 9 76296 529 63412188
Urticaria 15.24 11.49 282 76023 165520 63247197
Neoplasm progression 15.00 11.49 13 76292 36415 63376302
Genital rash 14.95 11.49 9 76296 555 63412162
Heart rate increased 14.87 11.49 176 76129 94062 63318655
Hospitalisation 14.82 11.49 162 76143 84919 63327798
Temporal lobe epilepsy 14.77 11.49 8 76297 403 63412314
Focal segmental glomerulosclerosis 14.73 11.49 13 76292 1455 63411262
Tubulointerstitial nephritis 14.70 11.49 3 76302 19900 63392817
Procedural anxiety 14.66 11.49 10 76295 766 63411951
Breast cancer 14.63 11.49 104 76201 48279 63364438
Exostosis 14.60 11.49 51 76254 17811 63394906
Tenosynovitis 14.56 11.49 43 76262 13752 63398965
Blood immunoglobulin E decreased 14.56 11.49 5 76300 80 63412637
Adrenal insufficiency 14.52 11.49 51 76254 17864 63394853
Bronchial wall thickening 14.49 11.49 13 76292 1486 63411231
Allergy to animal 14.47 11.49 12 76293 1234 63411483
Thoracic operation 14.42 11.49 6 76299 166 63412551
Panic attack 14.32 11.49 59 76246 22272 63390445
Respiratory arrest 14.25 11.49 11 76294 32634 63380083
Asthmatic crisis 14.22 11.49 14 76291 1799 63410918
Pregnancy 14.16 11.49 14 76291 36822 63375895
Hypothalamic pituitary adrenal axis suppression 14.15 11.49 6 76299 174 63412543
Diaphragmatic paralysis 14.12 11.49 9 76296 615 63412102
Haemorrhage 14.00 11.49 33 76272 60989 63351728
Pulmonary mass 13.94 11.49 59 76246 22537 63390180
Hypokalaemia 13.76 11.49 71 76234 103733 63308984
Sputum purulent 13.74 11.49 11 76294 1076 63411641
Device expulsion 13.74 11.49 13 76292 34909 63377808
Hereditary angioedema 13.74 11.49 29 76276 7533 63405184
Atrial fibrillation 13.70 11.49 83 76222 116553 63296164
Foetal exposure during pregnancy 13.66 11.49 11 76294 31951 63380766
Skin wrinkling 13.46 11.49 11 76294 1108 63411609
Rhinitis perennial 13.45 11.49 4 76301 39 63412678
Product administration error 13.45 11.49 58 76247 22339 63390378
Hypomagnesaemia 13.44 11.49 9 76296 28728 63383989
Allergic sinusitis 13.44 11.49 11 76294 1111 63411606
Diabetic ketoacidosis 13.37 11.49 4 76301 20501 63392216
Hypoglycaemia 13.37 11.49 33 76272 60032 63352685
Cerebral infarction 13.33 11.49 6 76299 23887 63388830
Pancreatitis relapsing 13.22 11.49 10 76295 900 63411817
Mesenteric haemorrhage 13.18 11.49 4 76301 42 63412675
Oropharyngeal oedema 13.12 11.49 7 76298 342 63412375
Vestibular disorder 13.03 11.49 12 76293 1419 63411298
Influenza 12.97 11.49 193 76112 108529 63304188
Prescribed underdose 12.97 11.49 10 76295 29679 63383038
Stress urinary incontinence 12.85 11.49 15 76290 2340 63410377
Unresponsive to stimuli 12.83 11.49 13 76292 33803 63378914
Peritoneal perforation 12.64 11.49 5 76300 121 63412596
Chronic sinusitis 12.59 11.49 39 76266 12804 63399913
Fractional exhaled nitric oxide increased 12.36 11.49 3 76302 12 63412705
Dry throat 12.36 11.49 26 76279 6739 63405978
Aphonia 12.22 11.49 33 76272 10030 63402687
Product deposit 12.22 11.49 6 76299 246 63412471
Exposure via skin contact 12.15 11.49 7 76298 398 63412319
Drug eruption 12.11 11.49 10 76295 28684 63384033
Ascites 11.98 11.49 19 76286 40709 63372008
Infusion site pruritus 11.97 11.49 24 76281 6011 63406706
Breast conserving surgery 11.97 11.49 10 76295 1039 63411678
Infusion site erythema 11.95 11.49 36 76269 11643 63401074
Seizure 11.89 11.49 102 76203 132532 63280185
Intraocular pressure increased 11.86 11.49 24 76281 6054 63406663
Bone hypertrophy 11.85 11.49 7 76298 417 63412300
Product administered to patient of inappropriate age 11.84 11.49 17 76288 3251 63409466
Infusion site swelling 11.83 11.49 32 76273 9738 63402979
Breath sounds absent 11.77 11.49 6 76299 267 63412450
Toxic epidermal necrolysis 11.76 11.49 8 76297 25326 63387391
Ear pain 11.72 11.49 79 76226 36039 63376678
Respiratory failure 11.70 11.49 73 76232 101785 63310932
Metastases to liver 11.61 11.49 7 76298 23632 63389085
Pneumocystis jirovecii pneumonia 11.59 11.49 3 76302 16911 63395806
Rhabdomyolysis 11.56 11.49 22 76283 43929 63368788
Erythema of eyelid 11.55 11.49 14 76291 2272 63410445

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Product quality issue 2851.29 12.16 929 32682 16106 34907214
No adverse event 2191.50 12.16 824 32787 22103 34901217
Poor quality device used 1475.43 12.16 306 33305 644 34922676
Product dose omission issue 1062.83 12.16 894 32717 118817 34804503
Asthma 535.74 12.16 392 33219 42264 34881056
Product container issue 423.28 12.16 105 33506 614 34922706
Device malfunction 379.57 12.16 190 33421 10231 34913089
Wheezing 373.37 12.16 313 33298 41089 34882231
Circumstance or information capable of leading to medication error 268.50 12.16 90 33521 1689 34921631
Cough 197.16 12.16 441 33170 149699 34773621
Chest discomfort 196.65 12.16 252 33359 54278 34869042
Obstructive airways disorder 173.26 12.16 133 33478 15361 34907959
Nasal congestion 159.20 12.16 150 33461 22907 34900413
Nasal polyps 158.34 12.16 67 33544 2436 34920884
Dyspnoea 155.89 12.16 744 32867 376038 34547282
Sleep disorder due to a general medical condition 132.90 12.16 75 33536 5146 34918174
Fractional exhaled nitric oxide increased 125.59 12.16 45 33566 1037 34922283
Toxicity to various agents 107.25 12.16 30 33581 200332 34722988
Plantar fasciitis 99.51 12.16 46 33565 2070 34921250
Death 96.86 12.16 146 33465 397903 34525417
Chronic sinusitis 96.25 12.16 46 33565 2233 34921087
Sensation of foreign body 93.28 12.16 48 33563 2735 34920585
Full blood count abnormal 91.54 12.16 101 33510 18567 34904753
Infective pulmonary exacerbation of cystic fibrosis 90.87 12.16 65 33546 6736 34916584
Sinusitis 87.65 12.16 149 33462 41253 34882067
Acute kidney injury 87.31 12.16 99 33512 304889 34618431
Myoglobin blood increased 83.97 12.16 46 33565 2977 34920343
Dyspnoea exertional 79.04 12.16 146 33465 43133 34880187
Drug abuse 72.81 12.16 6 33605 99090 34824230
Off label use 72.55 12.16 188 33423 419336 34503984
Rhinitis perennial 71.78 12.16 22 33589 305 34923015
Productive cough 70.85 12.16 129 33482 37684 34885636
Neutropenia 67.82 12.16 33 33578 156745 34766575
Upper-airway cough syndrome 66.77 12.16 42 33569 3516 34919804
Completed suicide 66.76 12.16 8 33603 98160 34825160
Secretion discharge 66.67 12.16 51 33560 5854 34917466
Steroid withdrawal syndrome 64.58 12.16 19 33592 227 34923093
Brain natriuretic peptide increased 61.97 12.16 48 33563 5611 34917709
Nasopharyngitis 61.68 12.16 177 33434 69791 34853529
Nasal discomfort 60.17 12.16 30 33581 1598 34921722
Anosmia 59.67 12.16 41 33570 3983 34919337
Thrombocytopenia 58.82 12.16 39 33572 156208 34767112
Dysphonia 57.39 12.16 90 33521 23293 34900027
Eosinophilic granulomatosis with polyangiitis 57.31 12.16 31 33580 1956 34921364
Exostosis 55.99 12.16 42 33569 4681 34918639
Poor quality product administered 55.69 12.16 30 33581 1877 34921443
Dermatitis atopic 51.38 12.16 42 33569 5305 34918015
Hypersensitivity 50.52 12.16 151 33460 60884 34862436
Dust allergy 49.92 12.16 22 33589 884 34922436
Incorrect dose administered 49.62 12.16 116 33495 40399 34882921
Anaemia 47.96 12.16 95 33516 233240 34690080
Adjustment disorder 46.97 12.16 23 33588 1178 34922142
Underdose 46.96 12.16 62 33549 13718 34909602
Product taste abnormal 44.47 12.16 22 33589 1152 34922168
Forced expiratory volume decreased 43.68 12.16 31 33580 3172 34920148
Rhinorrhoea 43.62 12.16 84 33527 25584 34897736
Painful respiration 43.40 12.16 22 33589 1214 34922106
Bronchopulmonary aspergillosis allergic 43.07 12.16 20 33591 909 34922411
Device dislocation 41.85 12.16 40 33571 6209 34917111
Rhinitis allergic 40.39 12.16 29 33582 3021 34920299
Adrenal suppression 39.86 12.16 17 33594 630 34922690
Obesity 39.42 12.16 55 33556 12823 34910497
Chest injury 38.19 12.16 22 33589 1569 34921751
Bronchial obstruction 37.87 12.16 22 33589 1594 34921726
Sinus polyp 37.80 12.16 12 33599 188 34923132
Pulmonary function test decreased 37.48 12.16 34 33577 4941 34918379
Platelet count decreased 37.36 12.16 36 33575 119681 34803639
Pleural thickening 37.23 12.16 14 33597 371 34922949
Nasal disorder 36.78 12.16 23 33588 1905 34921415
Renal failure 36.56 12.16 43 33568 130514 34792806
Eosinophilia 35.35 12.16 78 33533 26144 34897176
Multiple organ dysfunction syndrome 34.81 12.16 15 33596 76551 34846769
Oropharyngeal discomfort 34.76 12.16 27 33584 3169 34920151
Therapeutic product effect incomplete 34.47 12.16 117 33494 50424 34872896
Allergy to animal 32.87 12.16 13 33598 396 34922924
Hyperkalaemia 32.50 12.16 13 33598 69376 34853944
Walking aid user 31.87 12.16 21 33590 1903 34921417
Hepatic function abnormal 31.72 12.16 3 33608 44360 34878960
Gastrooesophageal reflux disease 31.53 12.16 94 33517 37830 34885490
Febrile neutropenia 31.40 12.16 52 33559 136797 34786523
Disease progression 30.90 12.16 35 33576 108042 34815278
Nasal oedema 30.58 12.16 12 33599 358 34922962
Oropharyngeal pain 30.50 12.16 89 33522 35396 34887924
Middle insomnia 30.26 12.16 35 33576 6767 34916553
Loss of personal independence in daily activities 30.24 12.16 85 33526 33094 34890226
Enterocolitis infectious 29.30 12.16 19 33592 1676 34921644
Eczema 28.50 12.16 58 33553 18378 34904942
Bradycardia 28.11 12.16 19 33592 75399 34847921
Malignant neoplasm progression 28.01 12.16 26 33585 88020 34835300
Respiratory tract congestion 28.00 12.16 32 33579 6107 34917213
Drug interaction 27.99 12.16 117 33494 225829 34697491
Tachyarrhythmia 27.85 12.16 25 33586 3583 34919737
Bronchial wall thickening 27.82 12.16 17 33594 1351 34921969
Seasonal allergy 27.46 12.16 33 33578 6642 34916678
Pancytopenia 27.00 12.16 31 33580 95126 34828194
Sleep apnoea syndrome 26.88 12.16 60 33551 20261 34903059
General physical health deterioration 26.50 12.16 52 33559 128217 34795103
Influenza 26.33 12.16 106 33505 49560 34873760
Throat irritation 26.32 12.16 41 33570 10544 34912776
Hypersomnia 25.37 12.16 44 33567 12363 34910957
Product odour abnormal 24.90 12.16 13 33598 763 34922557
Sputum discoloured 24.86 12.16 34 33577 7778 34915542
Cardio-respiratory arrest 24.85 12.16 11 33600 55262 34868058
Oral candidiasis 24.84 12.16 43 33568 12067 34911253
Central obesity 24.72 12.16 12 33599 603 34922717
Skin plaque 24.42 12.16 26 33585 4588 34918732
Tongue dry 24.20 12.16 9 33602 231 34923089
Increased viscosity of upper respiratory secretion 24.12 12.16 8 33603 145 34923175
Chorioretinopathy 24.02 12.16 16 33595 1477 34921843
Product quality control issue 23.79 12.16 4 33607 0 34923320
Hypotension 23.75 12.16 121 33490 221528 34701792
Sneezing 23.36 12.16 27 33584 5215 34918105
Ear infection 23.20 12.16 38 33573 10193 34913127
Septic shock 23.10 12.16 21 33590 71813 34851507
Pyrexia 23.09 12.16 207 33404 332806 34590514
Sepsis 22.68 12.16 83 33528 166478 34756842
Hot flush 22.41 12.16 52 33559 18014 34905306
Rhinitis 22.34 12.16 29 33582 6309 34917011
Aortic aneurysm 22.33 12.16 30 33581 6749 34916571
Leukopenia 21.90 12.16 17 33594 62839 34860481
Renal impairment 21.59 12.16 36 33575 94477 34828843
Wrong technique in device usage process 21.47 12.16 15 33596 1497 34921823
Encephalopathy 21.42 12.16 4 33607 35315 34888005
Cardiac disorder 21.25 12.16 90 33521 43036 34880284
Eosinophilic bronchitis 21.14 12.16 8 33603 216 34923104
Exercise lack of 20.99 12.16 7 33604 129 34923191
Feeling cold 20.81 12.16 37 33574 10602 34912718
Discomfort 20.79 12.16 52 33559 18886 34904434
Metabolic acidosis 20.75 12.16 8 33603 43672 34879648
Mast cell activation syndrome 20.28 12.16 8 33603 242 34923078
Bronchitis 20.23 12.16 87 33524 41876 34881444
Headache 20.06 12.16 287 33324 200348 34722972
Blood creatinine increased 20.04 12.16 38 33573 94938 34828382
Interstitial lung disease 19.92 12.16 20 33591 65262 34858058
Ascites 19.81 12.16 10 33601 46561 34876759
Somnolence 19.69 12.16 49 33562 111067 34812253
Maple syrup disease 19.41 12.16 4 33607 8 34923312
Temperature intolerance 19.39 12.16 20 33591 3402 34919918
Dry skin 19.23 12.16 70 33541 31217 34892103
Incorrect dose administered by product 19.02 12.16 5 33606 38 34923282
Fungal disease carrier 18.95 12.16 8 33603 289 34923031
Diarrhoea 18.85 12.16 263 33348 389649 34533671
Bronchiolitis 18.79 12.16 19 33592 3157 34920163
Growth retardation 18.78 12.16 15 33596 1833 34921487
Product availability issue 18.50 12.16 15 33596 1872 34921448
Cockroach allergy 18.47 12.16 5 33606 43 34923277
Confusional state 18.23 12.16 74 33537 144086 34779234
Sitting disability 18.22 12.16 7 33604 197 34923123
Cardiac arrest 18.16 12.16 41 33570 96118 34827202
Cystic fibrosis 18.01 12.16 14 33597 1644 34921676
Respiratory arrest 17.38 12.16 3 33608 28040 34895280
Gastrointestinal haemorrhage 17.30 12.16 37 33574 88440 34834880
Skin atrophy 17.12 12.16 15 33596 2082 34921238
Sleep disorder 17.08 12.16 68 33543 31620 34891700
Sinus disorder 17.00 12.16 27 33584 7058 34916262
Crepitations 16.90 12.16 18 33593 3178 34920142
Conjunctivitis 16.77 12.16 32 33579 9673 34913647
Myocardial infarction 16.70 12.16 60 33551 121025 34802295
Cataract 16.44 12.16 59 33552 26127 34897193
Papillary renal cell carcinoma 16.37 12.16 7 33604 261 34923059
Coma 16.37 12.16 12 33599 45666 34877654
Transaminases increased 16.34 12.16 3 33608 26820 34896500
Intentional overdose 16.27 12.16 11 33600 43663 34879657
Expired product administered 16.24 12.16 18 33593 3323 34919997
Snoring 16.21 12.16 18 33593 3328 34919992
C-reactive protein increased 16.02 12.16 17 33594 54081 34869239
Ear disorder 15.66 12.16 13 33598 1677 34921643
Bronchial irritation 15.63 12.16 4 33607 27 34923293
Hepatic failure 15.32 12.16 7 33604 34524 34888796
Pleural effusion 15.21 12.16 35 33576 81511 34841809
Rhabdomyolysis 14.62 12.16 27 33584 68136 34855184
Cholestasis 14.44 12.16 4 33607 26944 34896376
Aspartate aminotransferase increased 14.40 12.16 27 33584 67756 34855564
Dyspnoea at rest 14.26 12.16 18 33593 3810 34919510
Chronic obstructive pulmonary disease 14.19 12.16 88 33523 48830 34874490
Bronchiectasis 14.17 12.16 30 33581 9771 34913549
Hyposmia 14.10 12.16 6 33605 221 34923099
Polyp 14.02 12.16 18 33593 3874 34919446
Lactic acidosis 14.00 12.16 8 33603 34764 34888556
Delirium 13.97 12.16 13 33598 43978 34879342
Swollen tongue 13.88 12.16 38 33573 14567 34908753
Cytomegalovirus infection 13.79 12.16 4 33607 26131 34897189
Hyperleukocytosis 13.76 12.16 13 33598 1989 34921331
Pruritus 13.73 12.16 202 33409 141779 34781541
Drug resistance 13.62 12.16 4 33607 25923 34897397
Treatment failure 13.47 12.16 15 33596 46682 34876638
Haemoglobin decreased 13.44 12.16 65 33546 120707 34802613
Blood pressure decreased 13.33 12.16 18 33593 51497 34871823
Lung diffusion disorder 12.97 12.16 5 33606 142 34923178
Hypercholesterolaemia 12.88 12.16 27 33584 8735 34914585
Coronary artery disease 12.84 12.16 85 33526 48220 34875100
International normalised ratio increased 12.79 12.16 16 33595 47311 34876009
Primary familial brain calcification 12.48 12.16 3 33608 15 34923305
Skin weeping 12.31 12.16 7 33604 487 34922833
Haematochezia 12.30 12.16 16 33595 46518 34876802
Sputum abnormal 12.26 12.16 7 33604 491 34922829
Pleuritic pain 12.17 12.16 16 33595 3525 34919795

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
Product quality issue 2000.33 10.20 882 81655 33058 79628793
Poor quality device used 1994.45 10.20 465 82072 1820 79660031
Asthma 1045.03 10.20 966 81571 134129 79527722
Wheezing 660.01 10.20 704 81833 115960 79545891
No adverse event 644.72 10.20 429 82108 36763 79625088
Product dose omission issue 595.49 10.20 981 81556 246556 79415295
Gastrooesophageal reflux disease 564.84 10.20 615 81922 103631 79558220
Device malfunction 472.75 10.20 288 82249 21160 79640691
Rhinitis allergic 426.15 10.20 222 82315 12047 79649804
Sleep disorder due to a general medical condition 397.29 10.20 223 82314 14054 79647797
Cough 345.66 10.20 995 81542 365794 79296057
Nasal polyps 314.39 10.20 153 82384 7174 79654677
Ejection fraction 307.88 10.20 108 82429 2161 79659690
Circumstance or information capable of leading to medication error 303.34 10.20 124 82413 3824 79658027
Sputum discoloured 297.50 10.20 217 82320 21526 79640325
Polycystic ovaries 294.83 10.20 120 82417 3659 79658192
Sensitisation 292.53 10.20 115 82422 3196 79658655
Dyspnoea 268.47 10.20 1656 80881 855369 78806482
Nasal congestion 257.10 10.20 355 82182 76197 79585654
Productive cough 253.30 10.20 380 82157 87951 79573900
Product container issue 240.59 10.20 78 82459 1213 79660638
Full blood count abnormal 240.54 10.20 251 82286 40223 79621628
Toxicity to various agents 237.20 10.20 71 82466 421469 79240382
Completed suicide 222.60 10.20 7 82530 245760 79416091
Blood test abnormal 220.44 10.20 167 82370 17543 79644308
Obstructive airways disorder 192.15 10.20 198 82339 31261 79630590
Chest discomfort 184.94 10.20 428 82109 137616 79524235
Infective pulmonary exacerbation of cystic fibrosis 184.32 10.20 132 82405 12719 79649132
Acute kidney injury 161.43 10.20 180 82357 519224 79142627
Sleep apnoea syndrome 159.79 10.20 193 82344 36285 79625566
Pleural thickening 154.75 10.20 71 82466 2911 79658940
Death 147.60 10.20 224 82313 566290 79095561
Synovitis 141.30 10.20 3 82534 150731 79511120
Steroid withdrawal syndrome 140.23 10.20 45 82492 676 79661175
Drug abuse 139.28 10.20 7 82530 162684 79499167
Bronchiectasis 138.70 10.20 142 82395 22244 79639607
Presbyacusis 136.99 10.20 63 82474 2597 79659254
Bronchopulmonary aspergillosis allergic 134.57 10.20 65 82472 2996 79658855
Neutropenia 132.67 10.20 66 82471 287644 79374207
Carpal tunnel syndrome 130.39 10.20 129 82408 19399 79642452
Headache 118.70 10.20 1113 81424 652659 79009192
Therapeutic product effect incomplete 113.92 10.20 364 82173 141281 79520570
Total lung capacity increased 113.90 10.20 53 82484 2245 79659606
Pleural fibrosis 112.96 10.20 64 82473 4103 79657748
Sinusitis 111.59 10.20 449 82088 195052 79466799
Asthma-chronic obstructive pulmonary disease overlap syndrome 108.17 10.20 57 82480 3164 79658687
Off label use 106.31 10.20 531 82006 906684 78755167
Thrombocytopenia 103.77 10.20 74 82463 265185 79396666
Blood magnesium increased 98.16 10.20 55 82482 3451 79658400
Pneumonia aspiration 97.83 10.20 215 82322 66752 79595099
Loss of personal independence in daily activities 96.91 10.20 279 82258 102301 79559550
Ejection fraction abnormal 95.89 10.20 48 82489 2392 79659459
Eosinophilic granulomatosis with polyangiitis 93.29 10.20 54 82483 3606 79658245
Deafness neurosensory 92.42 10.20 68 82469 6830 79655021
Burning sensation 92.25 10.20 194 82343 58438 79603413
Rhinorrhoea 92.22 10.20 227 82310 75847 79586004
Nephrectomy 90.23 10.20 44 82493 2071 79659780
Nasal discomfort 87.19 10.20 60 82477 5423 79656428
Anaemia 86.04 10.20 210 82327 444805 79217046
Contraindicated product administered 85.83 10.20 28 82509 157510 79504341
Hand deformity 84.30 10.20 6 82531 103913 79557938
Upper-airway cough syndrome 83.22 10.20 80 82457 11613 79650238
Anosmia 81.58 10.20 70 82467 8774 79653077
Sinus disorder 81.16 10.20 108 82429 22356 79639495
Forced expiratory volume decreased 80.66 10.20 66 82471 7748 79654103
Bronchitis 76.05 10.20 302 82235 130342 79531509
Cardiac disorder 75.28 10.20 192 82345 65565 79596286
Middle insomnia 75.27 10.20 88 82449 15981 79645870
Systemic lupus erythematosus 74.49 10.20 17 82520 121132 79540719
Cyst 73.68 10.20 81 82456 13759 79648092
Rhinitis perennial 72.58 10.20 23 82514 331 79661520
Drug interaction 72.56 10.20 206 82331 414977 79246874
Epigastric discomfort 71.82 10.20 62 82475 7834 79654017
General physical health deterioration 70.39 10.20 110 82427 275128 79386723
Dermatitis atopic 70.06 10.20 68 82469 9988 79651863
Sarcoidosis 68.92 10.20 62 82475 8273 79653578
Oropharyngeal pain 68.72 10.20 259 82278 109094 79552757
Product taste abnormal 67.34 10.20 37 82500 2234 79659617
Intentional overdose 66.91 10.20 14 82523 105946 79555905
Bronchial obstruction 65.70 10.20 39 82498 2729 79659122
Pericarditis 65.35 10.20 14 82523 104222 79557629
Glossodynia 64.54 10.20 14 82523 103323 79558528
Multiple organ dysfunction syndrome 64.40 10.20 22 82515 120224 79541627
Platelet count decreased 63.06 10.20 65 82472 194599 79467252
Rales 63.00 10.20 90 82447 19911 79641940
Hyperkalaemia 62.90 10.20 20 82517 114378 79547473
Osteopenia 61.35 10.20 85 82452 18279 79643572
Nasal disorder 59.36 10.20 41 82496 3728 79658123
Overdose 59.11 10.20 62 82475 184144 79477707
Swollen tongue 58.04 10.20 133 82404 42437 79619414
Febrile neutropenia 57.46 10.20 94 82443 230905 79430946
Cardiac arrest 57.41 10.20 56 82481 172040 79489811
Sleep disorder 57.24 10.20 207 82330 85470 79576381
Helicobacter infection 56.60 10.20 4 82533 69700 79592151
Pancytopenia 56.38 10.20 53 82484 165692 79496159
Metabolic acidosis 56.20 10.20 9 82528 82520 79579331
Bone cyst 55.61 10.20 38 82499 3395 79658456
Dry eye 55.55 10.20 120 82417 36811 79625040
Cardiac murmur 55.51 10.20 75 82462 15749 79646102
Eczema 55.07 10.20 127 82410 40691 79621160
Chronic sinusitis 53.92 10.20 67 82470 12959 79648892
Hypothyroidism 53.88 10.20 147 82390 52245 79609606
Adrenal suppression 53.45 10.20 27 82510 1372 79660479
Heart sounds 53.28 10.20 24 82513 942 79660909
Leukopenia 53.24 10.20 27 82510 116486 79545365
Cardio-respiratory arrest 52.89 10.20 23 82514 108487 79553364
Hypotension 52.34 10.20 256 82281 440061 79221790
Swelling face 51.84 10.20 177 82360 71035 79590816
Confusional state 51.76 10.20 163 82374 317834 79344017
Renal disorder 51.39 10.20 126 82411 41979 79619872
Disease progression 50.71 10.20 70 82467 184292 79477559
Osteosclerosis 50.64 10.20 38 82499 3933 79657918
Pulmonary function test decreased 50.15 10.20 50 82487 7587 79654264
Prolonged expiration 49.94 10.20 25 82512 1246 79660605
Rheumatoid factor positive 49.87 10.20 3 82534 59836 79602015
Renal failure 49.77 10.20 82 82455 200886 79460965
Dyspnoea exertional 49.63 10.20 200 82337 86873 79574978
Chronic obstructive pulmonary disease 49.32 10.20 197 82340 85222 79576629
Respiratory tract congestion 49.01 10.20 80 82457 19874 79641977
Rhinitis 48.66 10.20 68 82469 14739 79647112
Incorrect dose administered 48.55 10.20 182 82355 76448 79585403
Dysphonia 48.29 10.20 149 82388 56723 79605128
Wrong technique in device usage process 47.96 10.20 37 82500 3991 79657860
Seasonal allergy 47.57 10.20 71 82466 16335 79645516
Septic shock 47.02 10.20 35 82502 122766 79539085
Asthenopia 46.92 10.20 30 82507 2397 79659454
Total lung capacity decreased 46.69 10.20 32 82505 2873 79658978
Maternal exposure during pregnancy 44.88 10.20 45 82492 136493 79525358
Sepsis 44.61 10.20 137 82400 269291 79392560
C-reactive protein increased 44.18 10.20 41 82496 128986 79532865
Respiration abnormal 43.94 10.20 47 82490 7741 79654110
Nasal mucosal disorder 43.69 10.20 16 82521 364 79661487
Infusion related reaction 43.36 10.20 110 82427 230127 79431724
Skin weeping 42.33 10.20 21 82516 1026 79660825
Wound 42.09 10.20 35 82502 116144 79545707
Lactic acidosis 41.06 10.20 11 82526 70348 79591503
Influenza 40.49 10.20 251 82286 129355 79532496
Hypersensitivity 40.35 10.20 432 82105 261807 79400044
Dust allergy 40.05 10.20 23 82514 1513 79660338
Hyponatraemia 39.17 10.20 78 82459 177770 79484081
Breast cancer 39.03 10.20 99 82438 33682 79628169
Joint swelling 38.96 10.20 160 82377 288486 79373365
Palpitations 38.80 10.20 244 82293 126366 79535485
Bone marrow failure 38.58 10.20 4 82533 51103 79610748
Encephalopathy 38.46 10.20 11 82526 67386 79594465
Urticaria 37.86 10.20 324 82213 184877 79476974
Nasal oedema 37.59 10.20 23 82514 1701 79660150
Painful respiration 37.40 10.20 30 82507 3423 79658428
Throat irritation 37.33 10.20 110 82427 40836 79621015
Nasopharyngitis 37.11 10.20 414 82123 253467 79408384
Mucosal inflammation 36.86 10.20 16 82521 75564 79586287
Tunnel vision 36.85 10.20 22 82515 1556 79660295
Hepatic function abnormal 36.42 10.20 15 82522 73092 79588759
Underdose 36.08 10.20 95 82442 33056 79628795
Interstitial lung disease 36.00 10.20 38 82499 112562 79549289
Bradycardia 34.79 10.20 54 82483 135503 79526348
Alveolar osteitis 34.32 10.20 17 82520 828 79661023
Increased viscosity of upper respiratory secretion 33.87 10.20 13 82524 338 79661513
Urinary tract discomfort 33.38 10.20 16 82521 725 79661126
Sinus pain 33.26 10.20 29 82508 3713 79658138
Therapy non-responder 33.20 10.20 28 82509 92277 79569574
Hepatic failure 33.11 10.20 11 82526 61201 79600650
Fibromyalgia 32.92 10.20 143 82394 64197 79597654
Condition aggravated 32.38 10.20 347 82190 500777 79161074
Sneezing 31.97 10.20 66 82471 19617 79642234
Poor quality product administered 31.90 10.20 28 82509 3617 79658234
Incorrect dose administered by product 31.88 10.20 11 82526 209 79661642
Sinus polyp 31.70 10.20 14 82523 524 79661327
International normalised ratio increased 31.34 10.20 25 82512 84696 79577155
Abdominal discomfort 30.78 10.20 144 82393 250583 79411268
Vomiting 30.58 10.20 495 82042 665333 78996518
Lung opacity 30.57 10.20 32 82505 5142 79656709
Skin plaque 30.44 10.20 46 82491 10699 79651152
Arthropathy 30.06 10.20 89 82448 177022 79484829
Delirium 30.04 10.20 26 82511 84601 79577250
Anxiety 29.24 10.20 389 82148 248123 79413728
Gastrointestinal haemorrhage 29.04 10.20 69 82468 147650 79514201
Hypomania 28.38 10.20 37 82500 7507 79654344
Electrocardiogram QT prolonged 28.34 10.20 31 82506 90355 79571496
Folliculitis 28.17 10.20 11 82526 55369 79606482
Animal scratch 27.95 10.20 18 82519 1456 79660395
Exostosis 27.94 10.20 57 82480 16801 79645050
Dehydration 27.90 10.20 147 82390 248040 79413811
Drug resistance 27.86 10.20 5 82532 42208 79619643
Muscle injury 27.57 10.20 8 82529 48553 79613298
Paranasal sinus discomfort 27.11 10.20 28 82509 4428 79657423
Feeling cold 26.97 10.20 78 82459 28651 79633200
Product odour abnormal 26.95 10.20 17 82520 1327 79660524
Swelling 26.87 10.20 124 82413 216587 79445264
Respiratory arrest 26.79 10.20 13 82524 57537 79604314
Impaired healing 26.46 10.20 31 82506 87624 79574227
Cytomegalovirus infection 26.17 10.20 6 82531 42638 79619213
Dry skin 26.01 10.20 139 82398 67856 79593995
Lung perforation 25.92 10.20 8 82529 105 79661746
Ascites 25.87 10.20 24 82513 75538 79586313
CFTR gene mutation 25.85 10.20 8 82529 106 79661745
Sinus congestion 25.85 10.20 61 82476 19835 79642016
Diarrhoea 25.61 10.20 705 81832 879784 78782067
Cardiogenic shock 25.52 10.20 6 82531 41908 79619943
Neutrophil count decreased 25.50 10.20 36 82501 93923 79567928
Coma 25.46 10.20 185 82352 100464 79561387
Suicide attempt 25.39 10.20 29 82508 82903 79578948
Product administered to patient of inappropriate age 25.32 10.20 30 82507 5523 79656328
Drug reaction with eosinophilia and systemic symptoms 24.99 10.20 18 82519 64226 79597625
Malignant neoplasm progression 24.80 10.20 66 82471 135924 79525927
Cystic fibrosis 24.73 10.20 25 82512 3855 79657996
Ear congestion 24.70 10.20 22 82515 2897 79658954
Intentional product use issue 24.70 10.20 78 82459 152034 79509817
Skin burning sensation 24.56 10.20 47 82490 13225 79648626
Bronchial wall thickening 24.55 10.20 21 82516 2620 79659231
Hypomagnesaemia 24.39 10.20 9 82528 46902 79614949
White blood cell count decreased 24.38 10.20 106 82431 188182 79473669
Croup infectious 24.32 10.20 13 82524 743 79661108
Skin fragility 24.29 10.20 14 82523 927 79660924
Toxic epidermal necrolysis 24.13 10.20 8 82529 44573 79617278
Myelosuppression 24.08 10.20 6 82531 40290 79621561
Diaphragmatic rupture 23.89 10.20 9 82528 222 79661629
Exposure to allergen 23.79 10.20 10 82527 331 79661520
Skin lesion 23.74 10.20 96 82441 41748 79620103
Growth retardation 23.46 10.20 18 82519 1925 79659926
Neurotoxicity 23.41 10.20 3 82534 32515 79629336
Migraine 23.40 10.20 163 82374 87330 79574521
Chest injury 23.36 10.20 21 82516 2800 79659051
Upper respiratory tract infection 23.30 10.20 168 82369 91000 79570851
Shock 23.25 10.20 8 82529 43540 79618311
Deformity 22.90 10.20 38 82499 9567 79652284
Rhabdomyolysis 22.90 10.20 45 82492 103086 79558765
Hospitalisation 22.58 10.20 171 82366 94065 79567786
Haemoglobin decreased 22.55 10.20 136 82401 221983 79439868
Perfume sensitivity 22.48 10.20 13 82524 866 79660985
Jaundice cholestatic 22.17 10.20 41 82496 11243 79650608
Disseminated intravascular coagulation 22.08 10.20 5 82532 35837 79626014
Type 2 diabetes mellitus 22.00 10.20 117 82420 57005 79604846
Blood calcium increased 21.98 10.20 39 82498 10361 79651490
Cardiac failure 21.39 10.20 85 82452 154757 79507094
Therapeutic product effect decreased 21.37 10.20 92 82445 163771 79498080
Depressed mood 21.27 10.20 103 82434 48377 79613474
Illness 21.26 10.20 100 82437 46411 79615440
Adiposis dolorosa 21.24 10.20 9 82528 304 79661547
Product availability issue 20.83 10.20 23 82514 3924 79657927
Central obesity 20.58 10.20 16 82521 1745 79660106
Red blood cell sedimentation rate increased 20.46 10.20 11 82526 45931 79615920
Hepatocellular injury 20.32 10.20 12 82525 47581 79614270
Alopecia 20.30 10.20 148 82389 231207 79430644
Altered state of consciousness 20.24 10.20 10 82527 43812 79618039
Oral candidiasis 20.13 10.20 72 82465 29556 79632295
Hip arthroplasty 20.10 10.20 6 82531 35750 79626101
Temperature intolerance 20.00 10.20 36 82501 9669 79652182
Hypokalaemia 19.94 10.20 79 82458 143961 79517890
Skin atrophy 19.90 10.20 27 82510 5691 79656160
Irritable bowel syndrome 19.89 10.20 21 82516 62220 79599631
Cognitive disorder 19.77 10.20 26 82511 69900 79591951
Blood potassium increased 19.77 10.20 71 82466 29204 79632647
Nasal dryness 19.74 10.20 24 82513 4539 79657312
Respiratory tract infection 19.63 10.20 101 82436 48588 79613263
Pyrexia 19.55 10.20 544 81993 678165 78983686
Acquired haemophilia 19.43 10.20 16 82521 1895 79659956
Liver injury 19.36 10.20 18 82519 56596 79605255
Oropharyngeal discomfort 19.34 10.20 30 82507 7136 79654715
Exposure during pregnancy 19.27 10.20 48 82489 101084 79560767
Lacrimation increased 19.18 10.20 59 82478 22418 79639433
Maple syrup disease 19.11 10.20 4 82533 8 79661843
Depressed level of consciousness 19.11 10.20 45 82492 96607 79565244
Adjustment disorder 18.89 10.20 22 82515 3978 79657873
Ureteral disorder 18.84 10.20 10 82527 563 79661288
Stress 18.81 10.20 144 82393 79468 79582383
Tubulointerstitial nephritis 18.79 10.20 8 82529 38227 79623624
Skin wrinkling 18.52 10.20 13 82524 1213 79660638
Device dislocation 18.41 10.20 64 82473 25906 79635945
Drug level increased 18.39 10.20 9 82528 39642 79622209
Adrenal insufficiency 18.32 10.20 68 82469 28419 79633432
Hereditary angioedema 18.28 10.20 25 82512 5310 79656541
Flail chest 18.18 10.20 6 82531 99 79661752
Cockroach allergy 18.07 10.20 6 82531 101 79661750
Decreased appetite 17.94 10.20 248 82289 342170 79319681
Acute myeloid leukaemia 17.70 10.20 5 82532 30880 79630971
Blood immunoglobulin E decreased 17.69 10.20 6 82531 108 79661743
Cerebral infarction 17.50 10.20 13 82524 45663 79616188
Panic attack 17.45 10.20 60 82477 24156 79637695
Cholestasis 17.32 10.20 17 82520 52092 79609759
Drug-induced liver injury 17.28 10.20 26 82511 66091 79595760
Epistaxis 17.26 10.20 184 82353 111331 79550520
Bronchial irritation 17.09 10.20 5 82532 54 79661797
Erythema marginatum 17.08 10.20 4 82533 16 79661835
Neoplasm progression 17.01 10.20 17 82520 51665 79610186
Hypoacusis 16.97 10.20 69 82468 30081 79631770
Purpura senile 16.73 10.20 9 82528 521 79661330
Polymyalgia rheumatica 16.67 10.20 22 82515 4515 79657336
Allergy to animal 16.66 10.20 13 82524 1426 79660425
Bladder pain 16.65 10.20 16 82521 2321 79659530
Tarsal tunnel syndrome 16.63 10.20 9 82528 527 79661324
Dystrophic calcification 16.53 10.20 6 82531 133 79661718
Increased upper airway secretion 16.52 10.20 21 82516 4156 79657695
Hypersomnia 16.46 10.20 57 82480 23029 79638822
Pulmonary eosinophilia 16.45 10.20 10 82527 731 79661120
Dry throat 16.41 10.20 29 82508 7677 79654174
Procedural anxiety 16.14 10.20 10 82527 756 79661095
Tongue pruritus 16.12 10.20 9 82528 561 79661290
Hyperbilirubinaemia 15.97 10.20 3 82534 24515 79637336
Haemoptysis 15.97 10.20 106 82431 55893 79605958
Genital rash 15.76 10.20 11 82526 1017 79660834
Orthostatic hypotension 15.76 10.20 21 82516 56143 79605708
Aortic aneurysm 15.74 10.20 30 82507 8416 79653435
Respiratory failure 15.73 10.20 116 82421 180795 79481056
Papillary renal cell carcinoma 15.70 10.20 7 82530 268 79661583
Eosinophil count increased 15.63 10.20 46 82491 17059 79644792
Expired product administered 15.62 10.20 27 82510 7024 79654827
Blood pressure increased 15.50 10.20 306 82231 211054 79450797
Tumour lysis syndrome 15.45 10.20 3 82534 23936 79637915
Chorioretinopathy 15.38 10.20 15 82522 2216 79659635
Acute hepatic failure 15.29 10.20 6 82531 30107 79631744
Burns third degree 15.03 10.20 8 82529 453 79661398
Sedation 14.98 10.20 19 82518 51876 79609975
Skin exfoliation 14.93 10.20 103 82434 54997 79606854
Osteoarthritis 14.91 10.20 147 82390 87162 79574689
Psoriatic arthropathy 14.88 10.20 37 82500 77962 79583889
Depressive symptom 14.76 10.20 25 82512 6398 79655453
Lower respiratory tract infection 14.65 10.20 201 82336 129019 79532832
Cholelithiasis 14.60 10.20 99 82438 52565 79609286
Tachyarrhythmia 14.57 10.20 26 82511 6936 79654915
Ear pain 14.54 10.20 70 82467 32799 79629052
Hepatic enzyme increased 14.52 10.20 120 82417 182490 79479361
Fall 14.49 10.20 389 82148 487240 79174611
Renal tubular necrosis 14.45 10.20 4 82533 25035 79636816
Neutropenic sepsis 14.40 10.20 5 82532 27059 79634792
Hypothalamic pituitary adrenal axis suppression 14.38 10.20 7 82530 328 79661523
Secretion discharge 14.31 10.20 41 82496 14981 79646870
Ear infection 14.28 10.20 72 82465 34360 79627491
Circulatory collapse 14.07 10.20 11 82526 37657 79624194
Myalgia 14.03 10.20 270 82267 185371 79476480
Fungal disease carrier 13.98 10.20 7 82530 349 79661502
Insomnia 13.87 10.20 342 82195 244828 79417023
Cushing's syndrome 13.76 10.20 10 82527 985 79660866
Thoracic operation 13.68 10.20 6 82531 221 79661630
Blood immunoglobulin E increased 13.66 10.20 23 82514 5859 79655992
Haematochezia 13.49 10.20 46 82491 87599 79574252
Obstruction 13.44 10.20 20 82517 4590 79657261
Breast conserving surgery 13.41 10.20 9 82528 781 79661070
Enthesopathy 13.39 10.20 34 82503 11574 79650277
Knee arthroplasty 13.37 10.20 15 82522 43233 79618618
Pneumonia 13.32 10.20 822 81715 659424 79002427
Sitting disability 13.26 10.20 7 82530 390 79661461
Respiratory depression 13.23 10.20 6 82531 27624 79634227
Rash macular 13.11 10.20 62 82475 28837 79633014
Forced expiratory volume abnormal 13.10 10.20 5 82532 128 79661723
Prescribed overdose 13.01 10.20 12 82525 37871 79623980
Pulmonary mass 12.96 10.20 62 82475 28972 79632879
Pruritus 12.89 10.20 515 82022 394133 79267718
Cytokine release syndrome 12.84 10.20 11 82526 35987 79625864
Hepatic cytolysis 12.84 10.20 6 82531 27145 79634706
Exposure to fungus 12.82 10.20 5 82532 136 79661715
Body temperature abnormal 12.81 10.20 14 82523 2361 79659490
Hypertension 12.76 10.20 440 82097 330552 79331299
Intentional self-injury 12.71 10.20 9 82528 32410 79629441
Allergic sinusitis 12.65 10.20 9 82528 858 79660993
Appetite disorder 12.62 10.20 26 82511 7713 79654138
Ear disorder 12.62 10.20 18 82519 3975 79657876
Product quality control issue 12.62 10.20 3 82534 13 79661838
Hearing disability 12.59 10.20 4 82533 58 79661793
Post-traumatic stress disorder 12.57 10.20 20 82517 4861 79656990
Hypothermia 12.46 10.20 4 82533 22742 79639109
Multiple allergies 12.44 10.20 31 82506 10429 79651422
Telangiectasia 12.42 10.20 11 82526 1438 79660413
Tongue dry 12.38 10.20 10 82527 1152 79660699
Pharyngeal oedema 12.32 10.20 41 82496 16231 79645620
Urosepsis 12.31 10.20 6 82531 26489 79635362
Primary familial brain calcification 12.26 10.20 3 82534 15 79661836
Breath sounds absent 12.23 10.20 6 82531 286 79661565
Subarachnoid haemorrhage 12.21 10.20 5 82532 24460 79637391
Plasma cell myeloma 12.03 10.20 23 82514 53236 79608615
Increased bronchial secretion 12.02 10.20 16 82521 3311 79658540
Inflammation 11.99 10.20 53 82484 93700 79568151
Eosinophilic bronchitis 11.86 10.20 7 82530 485 79661366
Peritoneal perforation 11.74 10.20 5 82532 171 79661680
Grip strength decreased 11.70 10.20 4 82533 21865 79639986
Aphonia 11.68 10.20 30 82507 10282 79651569
Coagulopathy 11.67 10.20 12 82525 35994 79625857
Seizure 11.66 10.20 132 82405 188702 79473149
Inguinal hernia repair 11.54 10.20 6 82531 324 79661527
Pancreatitis relapsing 11.53 10.20 9 82528 987 79660864
Mesenteric haemorrhage 11.50 10.20 4 82533 78 79661773
Diabetic ketoacidosis 11.49 10.20 11 82526 34111 79627740
Lung neoplasm malignant 11.44 10.20 58 82479 27734 79634117
Eye swelling 11.44 10.20 56 82481 26412 79635439
Eosinophil count abnormal 11.43 10.20 8 82529 743 79661108
Throat tightness 11.32 10.20 58 82479 27849 79634002
Lymphopenia 11.32 10.20 9 82528 30548 79631303
Brain oedema 11.32 10.20 6 82531 25257 79636594
Social fear 11.29 10.20 3 82534 22 79661829
Lung diffusion disorder 11.23 10.20 5 82532 191 79661660
Hot flush 11.19 10.20 96 82441 54781 79607070
Blister 11.17 10.20 75 82462 119401 79542450
Cardiac failure congestive 11.13 10.20 94 82443 142308 79519543
Ventricular fibrillation 11.10 10.20 10 82527 31916 79629935
Aspartate aminotransferase increased 11.07 10.20 91 82446 138550 79523301
Heart rate increased 11.04 10.20 181 82356 120543 79541308
Bronchospasm 11.04 10.20 53 82484 24806 79637045
Nasal polypectomy 10.95 10.20 3 82534 25 79661826
Wrist fracture 10.84 10.20 32 82505 11889 79649962
Bone hypertrophy 10.83 10.20 7 82530 570 79661281
Conjunctivitis 10.82 10.20 54 82483 25661 79636190
Product deposit 10.78 10.20 7 82530 574 79661277
Vestibular disorder 10.76 10.20 13 82524 2442 79659409
Calculus urinary 10.74 10.20 13 82524 2447 79659404
Lichenification 10.68 10.20 8 82529 825 79661026
Menopause 10.67 10.20 12 82525 2090 79659761
Diaphragmatic paralysis 10.66 10.20 9 82528 1103 79660748
Progressive multifocal leukoencephalopathy 10.63 10.20 4 82533 20596 79641255
Dermatitis allergic 10.61 10.20 42 82495 18088 79643763
Bronchiolitis 10.57 10.20 17 82520 4171 79657680
Serotonin syndrome 10.56 10.20 19 82518 45008 79616843
Stomatitis 10.53 10.20 99 82438 146658 79515193
Liver disorder 10.48 10.20 39 82498 72378 79589473
Basal cell carcinoma 10.46 10.20 14 82523 37361 79624490
Hepatic encephalopathy 10.45 10.20 6 82531 24160 79637691
Hypoglycaemia 10.41 10.20 62 82475 101532 79560319
Mental status changes 10.40 10.20 35 82502 66924 79594927
Pneumocystis jirovecii pneumonia 10.35 10.20 11 82526 32497 79629354
Wound secretion 10.34 10.20 21 82516 6167 79655684
Intentional product misuse 10.33 10.20 57 82480 95108 79566743
Accident 10.32 10.20 26 82511 8805 79653046
Obesity 10.32 10.20 67 82470 35058 79626793
Haemodialysis 10.30 10.20 3 82534 18165 79643686
Haemorrhage 10.21 10.20 54 82483 91064 79570787

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D07AC13 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, potent (group III)
ATC D07XC03 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, OTHER COMBINATIONS
Corticosteroids, potent, other combinations
ATC R01AD09 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R01AD59 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R03AK09 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK14 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AL12 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03BA07 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Glucocorticoids
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists
FDA EPC N0000175576 Corticosteroid
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D003879 Dermatologic Agents
CHEBI has role CHEBI:35472 anti-inflammatory drugs
CHEBI has role CHEBI:50177 dermatologic agent
CHEBI has role CHEBI:50857 anti-allergic drugs

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

DiseaseRelationSNOMED_IDDOID
Atopic dermatitis indication 24079001 DOID:3310
Contact dermatitis indication 40275004 DOID:2773
Seborrheic dermatitis indication 50563003 DOID:8741
Lichen simplex chronicus indication 53891004
Allergic rhinitis indication 61582004
Granuloma annulare indication 65508009 DOID:3777
Pruritus ani indication 90446007
Asthma indication 195967001 DOID:2841
Discoid lupus erythematosus indication 200938002
Plaque psoriasis indication 200965009
Scalp psoriasis indication 238608008
Non-allergic asthma indication 266361008 DOID:9360
Pruritus of genital organs indication 267802000
Eruption of skin indication 271807003 DOID:0050486
Allergic asthma indication 389145006 DOID:9415
Primary cutaneous T-cell lymphoma indication 400122007
Asthma management indication 406162001
Allergic Rhinitis Prevention indication
Chronic Non-Allergic Rhinitis indication
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
Asthenia contraindication 13791008
Measles contraindication 14189004 DOID:8622
Disease caused by parasite contraindication 17322007
Glaucoma contraindication 23986001 DOID:1686
Acute tuberculosis contraindication 25629007
Immunosuppression contraindication 38013005
Hypertensive disorder contraindication 38341003 DOID:10763
Varicella contraindication 38907003 DOID:8659
Hypokalemia contraindication 43339004
Conduction disorder of the heart contraindication 44808001
Skin ulcer contraindication 46742003
Osteoporosis contraindication 64859006 DOID:11476
Diabetes mellitus contraindication 73211009 DOID:9351
Hypopituitarism contraindication 74728003 DOID:9406
Perforation of nasal septum contraindication 80142000
Bacterial infectious disease contraindication 87628006
Operation on nose contraindication 88733004
Thyrotoxicosis contraindication 90739004 DOID:7997
Fissure in skin contraindication 95321009
Bilateral cataracts contraindication 95722004
Prolonged QT interval contraindication 111975006
Seizure disorder contraindication 128613002
Ophthalmic herpes simplex contraindication 186542001
Disease of liver contraindication 235856003 DOID:409
Telangiectasia disorder contraindication 247479008
Exacerbation of asthma contraindication 281239006
Varicella-zoster virus infection contraindication 309465005
Osteopenia contraindication 312894000
Skin irritation contraindication 367466007
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Atrophoderma contraindication 399979006
Peripheral vascular disease contraindication 400047006
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Denuded skin contraindication 418242004
Congenital long QT syndrome contraindication 442917000
Nasal Septal Ulcers contraindication
Untreated Fungal Infection contraindication
Nasal Trauma contraindication
Nasal Candidiasis contraindication
Uncontrolled Bacterial Infections contraindication




🐶 Veterinary Drug Use

SpeciesUseRelation
Dogs Otitis externa Indication

🐶 Veterinary products

ProductApplicantIngredients
Mometamax Otic Suspension Intervet Inc. 3
Posatex Otic Suspension Intervet Inc. 3
CLARO Elanco US Inc. 3
Mometavet Med-Pharmex Inc. 3

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.01 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 7662141 March 12, 2024 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 7713255 March 12, 2024 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 7951130 March 12, 2024 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 7951131 March 12, 2024 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 7951133 March 12, 2024 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 8109918 March 12, 2024 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 9585681 April 4, 2026 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 7544192 Nov. 29, 2026 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 8025635 June 12, 2027 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 10357640 Oct. 3, 2031 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10016443 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10517880 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10548907 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10646500 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10758550 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE TO A PEDIATRIC PATIENT
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10765686 Sept. 4, 2034 METHOD OF DELIVERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE TO A NASAL AIRWAY
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 11400101 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 9078923 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 9750754 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 10232152 Nov. 24, 2034 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.005MG/INH;0.05MG/INH DULERA ORGANON LLC N022518 Aug. 12, 2019 RX AEROSOL, METERED INHALATION Feb. 12, 2023 PEDIATRIC EXCLUSIVITY
0.05MG/INH ASMANEX HFA ORGANON LLC N205641 Aug. 12, 2019 RX AEROSOL, METERED INHALATION Feb. 12, 2023 PEDIATRIC EXCLUSIVITY
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL Jan. 13, 2025 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST Ki 9.15 CHEMBL CHEMBL
Multidrug resistance protein 1 Transporter IC50 6.13 WOMBAT-PK
Progesterone receptor Nuclear hormone receptor EC50 9.90 WOMBAT-PK

External reference:

IDSource
4019844 VUID
N0000147931 NUI
D00690 KEGG_DRUG
4019367 VANDF
4019844 VANDF
4021125 VANDF
C0066700 UMLSCUI
CHEBI:47564 CHEBI
CHEBI:6970 CHEBI
MOF PDB_CHEM_ID
CHEMBL1161 ChEMBL_ID
D000068656 MESH_DESCRIPTOR_UI
DB14512 DRUGBANK_ID
141646-00-6 SECONDARY_CAS_RN
04201GDN4R UNII
441336 PUBCHEM_CID
DB00764 DRUGBANK_ID
108118 RXNORM
11404 MMSL
239640 MMSL
5129 MMSL
5130 MMSL
d05262 MMSL
002205 NDDF
395802006 SNOMEDCT_US
395803001 SNOMEDCT_US
395990009 SNOMEDCT_US
75203002 SNOMEDCT_US
C0360564 UMLSCUI
6030 INN_ID
105102-22-5 SECONDARY_CAS_RN
441335 PUBCHEM_CID
9029 IUPHAR_LIGAND_ID
8HR4QJ6DW8 UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Dulera HUMAN PRESCRIPTION DRUG LABEL 2 0085-4610 AEROSOL 200 ug RESPIRATORY (INHALATION) NDA 29 sections
Dulera HUMAN PRESCRIPTION DRUG LABEL 2 0085-7206 AEROSOL 100 ug RESPIRATORY (INHALATION) NDA 29 sections
Nasonex HUMAN OTC DRUG LABEL 1 0113-1720 SPRAY 50 ug NASAL NDA 17 sections
Nasonex HUMAN OTC DRUG LABEL 1 0113-1720 SPRAY 50 ug NASAL NDA 17 sections
Childrens Nasonex HUMAN OTC DRUG LABEL 1 0113-1999 SPRAY 50 ug NASAL NDA 17 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0270 CREAM 1 mg TOPICAL ANDA 28 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0271 OINTMENT 1 mg TOPICAL ANDA 28 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0272 SOLUTION 1 mg TOPICAL ANDA 29 sections
allergy nasal HUMAN OTC DRUG LABEL 1 0363-2060 SPRAY 50 ug NASAL NDA 17 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0634 CREAM 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0634 CREAM 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0635 OINTMENT 1 mg TOPICAL ANDA 24 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0701 SOLUTION 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0701 SOLUTION 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0726 CREAM 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0726 CREAM 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0727 OINTMENT 1 mg TOPICAL ANDA 24 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0727 OINTMENT 1 mg TOPICAL ANDA 24 sections
Sinuva HUMAN PRESCRIPTION DRUG LABEL 1 10599-003 IMPLANT 1350 ug INTRASINAL NDA 29 sections
Sinuva HUMAN PRESCRIPTION DRUG LABEL 1 10599-003 IMPLANT 1350 ug INTRASINAL NDA 29 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 13668-527 OINTMENT 1 mg TOPICAL ANDA 26 sections
MOMETASONE FUROATE HUMAN PRESCRIPTION DRUG LABEL 1 16590-993 CREAM 1 mg TOPICAL ANDA 10 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 16714-974 CREAM 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 21695-786 CREAM 1 mg TOPICAL ANDA 13 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 42254-175 OINTMENT 1 mg TOPICAL ANDA 13 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 45802-118 SOLUTION 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 45802-118 SOLUTION 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 45802-119 OINTMENT 1 mg TOPICAL ANDA 29 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 45802-257 CREAM 1 mg TOPICAL ANDA 29 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 45802-257 CREAM 1 mg TOPICAL ANDA 29 sections