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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 4.185 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.589 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 28.184 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 35.156 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 0.260 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 0.540 % High 1
herg hERG pIC50 4.848 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 178.238 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 223.872 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 0.430 % High 1
kinase-safety-class ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,JAK2,JAK3,MAP2K6,MAP3K7,MAPK10,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKDC,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 40
kinase-selectivity-class AXL,GRK2,MAP2K6,MAP3K14,STK33,TEK 6
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.065 High 1
mh-clint Mouse hepatocyte intrinsic clearance 166.725 High 1
mppb Mouse plasma protein binding (% unbound) 0.410 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 8.995 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 Moderate 0.66
pppb Pig plasma protein binding (% unbound) 1.090 % High 1
rh-clint Rat hepatocyte intrinsic clearance 209.894 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 3.670 % High 1
rppb Rat plasma protein binding (% unbound) 0.330 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 0.755 uM High 1

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 3841.43 11.43 1782 89772 77543 90459350
No adverse event 2602.89 11.43 1301 90253 66681 90470212
Poor quality device used 2539.24 11.43 564 90990 1729 90535164
Product dose omission issue 1908.76 11.43 1878 89676 289809 90247084
Asthma 634.63 11.43 985 90569 241175 90295718
Product container issue 619.33 11.43 181 91373 2000 90534893
Rhinitis allergic 617.01 11.43 313 91241 16472 90520421
Gastrooesophageal reflux disease 601.41 11.43 789 90765 165548 90371345
Device malfunction 559.55 11.43 316 91238 20661 90516232
Nasal polyps 408.94 11.43 206 91348 10674 90526219
Sputum discoloured 387.46 11.43 247 91307 20144 90516749
Cough 366.78 11.43 1005 90549 367957 90168936
Circumstance or information capable of leading to medication error 364.78 11.43 150 91404 4817 90532076
Ejection fraction 346.33 11.43 126 91428 2885 90534008
Wheezing 344.92 11.43 750 90804 237330 90299563
Sensitisation 340.69 11.43 136 91418 4039 90532854
Bronchiectasis 329.18 11.43 231 91323 22099 90514794
Polycystic ovaries 313.69 11.43 140 91414 5514 90531379
Synovitis 299.66 11.43 7 91547 329745 90207148
Blood test abnormal 297.85 11.43 212 91342 20740 90516153
Sleep apnoea syndrome 291.60 11.43 248 91306 31499 90505394
Productive cough 286.61 11.43 371 91183 76692 90460201
Asthma-chronic obstructive pulmonary disease overlap syndrome 283.67 11.43 125 91429 4774 90532119
Obstructive airways disorder 275.03 11.43 220 91334 25649 90511244
Total lung capacity increased 271.14 11.43 122 91432 4899 90531994
Glossodynia 270.75 11.43 13 91541 321766 90215127
Hand deformity 266.57 11.43 7 91547 296355 90240538
Full blood count abnormal 263.14 11.43 249 91305 36348 90500545
Sleep disorder due to a general medical condition 249.18 11.43 265 91289 44473 90492420
Systemic lupus erythematosus 246.74 11.43 36 91518 361860 90175033
Pericarditis 240.65 11.43 7 91547 270144 90266749
Dysphonia 239.72 11.43 307 91247 62777 90474116
Dyspnoea 233.67 11.43 1604 89950 879351 89657542
Wound 218.88 11.43 25 91529 302955 90233938
Swollen tongue 217.56 11.43 250 91304 45706 90491187
Swelling face 209.88 11.43 329 91225 81023 90455870
Contraindicated product administered 208.83 11.43 36 91518 320103 90216790
Sarcoidosis 207.01 11.43 131 91423 10542 90526351
Helicobacter infection 205.32 11.43 5 91549 226845 90310048
Nasal congestion 190.23 11.43 319 91235 83095 90453798
Bronchopulmonary aspergillosis allergic 173.62 11.43 82 91472 3684 90533209
Folliculitis 172.65 11.43 8 91546 204345 90332548
Pneumonia aspiration 171.11 11.43 209 91345 40731 90496162
Incorrect dose administered 170.92 11.43 295 91259 78635 90458258
Cardiac murmur 158.67 11.43 138 91416 18056 90518837
Angioedema 158.55 11.43 256 91298 64620 90472273
Burning sensation 157.28 11.43 252 91302 63200 90473693
Carpal tunnel syndrome 155.43 11.43 154 91400 23774 90513119
Chest discomfort 150.30 11.43 390 91164 137975 90398918
Impaired healing 149.07 11.43 28 91526 234171 90302722
Toxicity to various agents 147.87 11.43 53 91501 287793 90249100
Presbyacusis 145.68 11.43 68 91486 2974 90533919
Rheumatoid factor positive 144.09 11.43 7 91547 171643 90365250
Arthropathy 143.53 11.43 97 91457 366145 90170748
Maternal exposure during pregnancy 142.94 11.43 94 91460 359969 90176924
Pleural fibrosis 140.75 11.43 70 91484 3526 90533367
Infective pulmonary exacerbation of cystic fibrosis 139.19 11.43 101 91453 10178 90526715
Irritable bowel syndrome 135.94 11.43 23 91531 207425 90329468
Rales 135.91 11.43 119 91435 15708 90521185
Abdominal discomfort 135.50 11.43 170 91384 477158 90059735
Completed suicide 131.99 11.43 3 91551 145055 90391838
Infusion related reaction 130.66 11.43 137 91417 416643 90120250
Alopecia 128.72 11.43 188 91366 494883 90042010
Steroid withdrawal syndrome 127.59 11.43 41 91513 635 90536258
Ejection fraction abnormal 126.51 11.43 58 91496 2433 90534460
Pleural thickening 126.46 11.43 63 91491 3185 90533708
General physical health deterioration 123.86 11.43 106 91448 355009 90181884
Swelling 123.40 11.43 145 91409 418913 90117980
Liver injury 123.30 11.43 14 91540 170553 90366340
Headache 121.65 11.43 1368 90186 861378 89675515
Joint swelling 121.42 11.43 201 91353 503099 90033794
Blood magnesium increased 120.69 11.43 62 91492 3346 90533547
Chronic obstructive pulmonary disease 119.94 11.43 244 91310 73585 90463308
Nephrectomy 116.16 11.43 51 91503 1930 90534963
Deafness neurosensory 113.16 11.43 76 91478 6765 90530128
Hypomania 112.75 11.43 84 91470 8813 90528080
Jaundice cholestatic 112.29 11.43 88 91466 9955 90526938
Confusional state 107.01 11.43 140 91414 386065 90150828
Rhinitis 106.53 11.43 97 91457 13475 90523418
Cardiac disorder 103.31 11.43 197 91357 56675 90480218
Dermatitis atopic 103.25 11.43 123 91431 23349 90513544
Lung opacity 96.66 11.43 66 91488 6036 90530857
Lung neoplasm malignant 95.13 11.43 120 91434 24153 90512740
Hypothyroidism 91.58 11.43 180 91374 52947 90483946
Epigastric discomfort 90.47 11.43 69 91485 7499 90529394
Upper-airway cough syndrome 90.23 11.43 93 91461 15042 90521851
Total lung capacity decreased 90.05 11.43 53 91501 3742 90533151
Factor V Leiden mutation 89.13 11.43 26 91528 285 90536608
Asthma exercise induced 88.91 11.43 29 91525 472 90536421
Sinus disorder 88.36 11.43 139 91415 34308 90502585
Acute kidney injury 87.84 11.43 117 91437 320270 90216623
Drug ineffective for unapproved indication 86.27 11.43 201 91353 66443 90470450
Cyst 85.02 11.43 94 91460 16467 90520426
Psoriatic arthropathy 84.77 11.43 64 91490 228271 90308622
Rhinorrhoea 82.91 11.43 236 91318 88080 90448813
C-reactive protein increased 82.48 11.43 40 91514 181349 90355544
Coma 82.20 11.43 208 91346 72424 90464469
Lip dry 81.96 11.43 5 91549 100950 90435943
Cholelithiasis 81.12 11.43 170 91384 52336 90484557
Schizophrenia 80.64 11.43 87 91467 14827 90522066
Renal disorder 79.97 11.43 140 91414 37719 90499174
Neutropenia 79.76 11.43 66 91488 224838 90312055
Joint range of motion decreased 78.61 11.43 20 91534 135623 90401270
Nasal discomfort 78.52 11.43 56 91498 5492 90531401
Therapeutic product effect decreased 77.48 11.43 100 91454 277471 90259422
Oropharyngeal pain 75.45 11.43 272 91282 114915 90421978
Urinary tract discomfort 75.42 11.43 30 91524 882 90536011
Therapeutic product effect incomplete 73.29 11.43 388 91166 193508 90343385
Intentional overdose 72.28 11.43 6 91548 93828 90443065
Death 72.18 11.43 229 91325 456322 90080571
Sinus pain 70.81 11.43 52 91502 5337 90531556
Bone cyst 69.33 11.43 38 91516 2340 90534553
Wound infection 69.23 11.43 12 91542 106390 90430503
Product taste abnormal 68.13 11.43 38 91516 2422 90534471
Thrombocytopenia 67.16 11.43 67 91487 208658 90328235
Osteopenia 66.31 11.43 98 91456 22904 90513989
Prolonged expiration 66.14 11.43 30 91524 1227 90535666
Stomatitis 65.87 11.43 110 91444 274588 90262305
Heart sounds 65.62 11.43 29 91525 1115 90535778
Alveolar osteitis 64.82 11.43 29 91525 1148 90535745
Bronchitis 61.92 11.43 312 91242 152615 90384278
Blister 61.24 11.43 102 91452 254896 90281997
Middle insomnia 61.22 11.43 80 91474 16671 90520222
Grip strength decreased 61.20 11.43 10 91544 92566 90444327
Animal scratch 61.09 11.43 32 91522 1798 90535095
Live birth 61.09 11.43 5 91549 79102 90457791
Tunnel vision 60.39 11.43 31 91523 1670 90535223
Discomfort 60.25 11.43 116 91438 274219 90262674
Paranasal sinus discomfort 60.07 11.43 50 91504 6160 90530733
Ill-defined disorder 58.73 11.43 60 91494 184831 90352062
Mobility decreased 58.64 11.43 102 91452 250632 90286261
Peripheral venous disease 57.93 11.43 8 91546 83913 90452980
Anosmia 57.78 11.43 60 91494 9788 90527105
Bronchial obstruction 57.72 11.43 30 91524 1659 90535234
Hepatic enzyme increased 57.64 11.43 180 91374 360556 90176337
Blood cholesterol increased 56.94 11.43 76 91478 207936 90328957
Hypercholesterolaemia 56.34 11.43 16 91538 100876 90436017
Somnolence 55.13 11.43 381 91173 208703 90328190
Therapy non-responder 55.12 11.43 35 91519 136669 90400224
Knee arthroplasty 54.96 11.43 9 91545 83173 90453720
Dry eye 54.55 11.43 155 91399 57776 90479117
Red blood cell sedimentation rate increased 54.43 11.43 9 91545 82586 90454307
Underdose 54.28 11.43 148 91406 53869 90483024
Delirium 53.91 11.43 19 91535 104340 90432553
Autoimmune disorder 53.72 11.43 7 91547 76737 90460156
Road traffic accident 53.24 11.43 21 91533 107605 90429288
Vomiting 52.60 11.43 526 91028 787767 89749126
Eczema 52.28 11.43 144 91410 52726 90484167
Intentional product use issue 51.85 11.43 87 91467 216805 90320088
Ear congestion 51.63 11.43 36 91518 3406 90533487
Poor quality product administered 51.14 11.43 38 91516 3970 90532923
Blood calcium increased 51.08 11.43 62 91492 11996 90524897
CFTR gene mutation 50.70 11.43 16 91538 233 90536660
Sleep disorder due to general medical condition, insomnia type 50.46 11.43 34 91520 128660 90408233
Psychotic disorder 50.45 11.43 103 91451 31127 90505766
Drug abuse 49.96 11.43 11 91543 82336 90454557
Sinusitis 49.87 11.43 548 91006 342540 90194353
Loss of personal independence in daily activities 49.80 11.43 270 91284 135835 90401058
Haemoptysis 49.28 11.43 106 91448 33214 90503679
Night sweats 49.18 11.43 35 91519 128731 90408162
Bladder pain 49.13 11.43 32 91522 2705 90534188
Eosinophilic granulomatosis with polyangiitis 48.92 11.43 31 91523 2499 90534394
Osteosclerosis 48.61 11.43 38 91516 4282 90532611
Off label use 48.53 11.43 803 90751 1101449 89435444
Wrong technique in device usage process 48.35 11.43 43 91511 5792 90531101
Occupational asthma 46.92 11.43 14 91540 167 90536726
Sciatica 46.62 11.43 22 91532 101360 90435533
Hip arthroplasty 46.60 11.43 10 91544 76198 90460695
Leukopenia 46.08 11.43 22 91532 100688 90436205
Drug-induced liver injury 45.71 11.43 17 91537 90301 90446592
Prescribed underdose 45.56 11.43 10 91544 75009 90461884
Treatment failure 44.85 11.43 157 91397 303771 90233122
Dry mouth 44.76 11.43 73 91481 183986 90352907
Decreased appetite 44.61 11.43 212 91342 376328 90160565
Musculoskeletal pain 43.46 11.43 66 91488 171185 90365708
Mouth breathing 43.42 11.43 13 91541 157 90536736
Skin lesion 43.31 11.43 108 91446 37257 90499636
Palpitations 43.30 11.43 261 91293 136467 90400426
Peripheral swelling 43.08 11.43 243 91311 412863 90124030
Lower limb fracture 43.02 11.43 16 91538 84997 90451896
Product odour abnormal 42.78 11.43 24 91530 1547 90535346
Gait inability 42.69 11.43 51 91503 146405 90390488
Myelosuppression 42.47 11.43 3 91551 53588 90483305
Inappropriate schedule of product administration 42.37 11.43 278 91276 149655 90387238
Respiration abnormal 42.26 11.43 46 91508 7917 90528976
Multiple organ dysfunction syndrome 41.72 11.43 9 91545 68327 90468566
Overdose 40.78 11.43 60 91494 157649 90379244
Forced expiratory volume decreased 40.75 11.43 39 91515 5769 90531124
Drug interaction 40.66 11.43 143 91411 276310 90260583
Rheumatoid arthritis 40.17 11.43 209 91345 362405 90174488
Dyspnoea exertional 40.15 11.43 162 91392 72126 90464767
Aspiration 39.79 11.43 63 91491 15630 90521263
Pancytopenia 39.36 11.43 38 91516 120225 90416668
Hyperkalaemia 38.76 11.43 9 91545 64955 90471938
Seasonal allergy 38.55 11.43 77 91477 22906 90513987
Expired product administered 38.52 11.43 41 91513 6881 90530012
Asthenopia 38.02 11.43 28 91526 2886 90534007
Lupus-like syndrome 37.96 11.43 3 91551 48843 90488050
Liver disorder 37.77 11.43 40 91514 121229 90415664
Product use issue 37.76 11.43 188 91366 329731 90207162
Inflammation 37.07 11.43 78 91476 178514 90358379
Myalgia 37.04 11.43 303 91251 174822 90362071
Metabolic acidosis 36.83 11.43 6 91548 55670 90481223
Skin weeping 36.75 11.43 27 91527 2773 90534120
Prescribed overdose 36.67 11.43 27 91527 97598 90439295
Vaccination site pain 36.35 11.43 14 91540 377 90536516
Obesity 36.11 11.43 32 91522 105475 90431418
Epilepsy 36.04 11.43 19 91535 82187 90454706
Wound secretion 35.94 11.43 34 91520 4956 90531937
Oesophageal dilatation 35.56 11.43 15 91539 514 90536379
Adrenal suppression 34.70 11.43 18 91536 991 90535902
Blepharospasm 34.47 11.43 7 91547 55438 90481455
Anaphylactic reaction 34.31 11.43 177 91377 87347 90449546
Hypoaesthesia 34.29 11.43 182 91372 314028 90222865
Joint stiffness 34.27 11.43 18 91536 78024 90458869
Pain 34.20 11.43 757 90797 995584 89541309
Exposure during pregnancy 33.94 11.43 125 91429 238285 90298608
Upper respiratory tract infection 33.90 11.43 234 91320 128084 90408809
Calculus urinary 33.32 11.43 21 91533 1677 90535216
Epistaxis 33.27 11.43 172 91382 84953 90451940
Hypotension 33.05 11.43 193 91361 325204 90211689
Blood potassium increased 33.00 11.43 68 91486 20681 90516212
Respiratory tract congestion 32.58 11.43 80 91474 27330 90509563
Pneumonia 32.51 11.43 859 90695 637200 89899693
Pre-existing condition improved 32.28 11.43 43 91511 9126 90527767
Lactic acidosis 32.15 11.43 6 91548 50457 90486436
Throat irritation 31.87 11.43 115 91439 48580 90488313
Platelet count decreased 31.75 11.43 56 91498 136913 90399980
Anaemia 30.86 11.43 219 91335 352583 90184310
Septic shock 30.68 11.43 24 91530 84136 90452757
Foot deformity 30.57 11.43 11 91543 59640 90477253
Polymyalgia rheumatica 30.42 11.43 31 91523 4946 90531947
Diarrhoea 30.13 11.43 721 90833 938469 89598424
Incorrect dose administered by product 29.98 11.43 11 91543 258 90536635
Disease progression 29.57 11.43 72 91482 156543 90380350
Dyspepsia 29.46 11.43 102 91452 198058 90338835
Pregnancy 29.24 11.43 13 91541 62034 90474859
Gastrointestinal disorder 28.94 11.43 147 91407 256540 90280353
Female sterilisation 28.83 11.43 14 91540 669 90536224
Nasal disorder 28.76 11.43 25 91529 3267 90533626
Back injury 28.75 11.43 6 91548 46616 90490277
Bone erosion 28.52 11.43 9 91545 53012 90483881
Illness 28.23 11.43 160 91394 81809 90455084
Acquired haemophilia 28.21 11.43 16 91538 1053 90535840
Cardiac arrest 28.03 11.43 39 91515 104896 90431997
Wound complication 27.91 11.43 29 91525 4734 90532159
Circumstance or information capable of leading to device use error 27.85 11.43 10 91544 220 90536673
Febrile neutropenia 27.44 11.43 76 91478 158273 90378620
Glaucoma 27.29 11.43 63 91491 20692 90516201
Hepatic cirrhosis 27.17 11.43 15 91539 63238 90473655
Depressive symptom 27.13 11.43 30 91524 5255 90531638
Pancreatitis relapsing 26.96 11.43 17 91537 1359 90535534
Lung perforation 26.77 11.43 8 91546 96 90536797
Bronchial wall thickening 26.73 11.43 20 91534 2111 90534782
Painful respiration 26.53 11.43 23 91531 2995 90533898
Heart rate increased 26.42 11.43 200 91354 112702 90424191
Sinus congestion 26.42 11.43 74 91480 27350 90509543
Memory impairment 26.40 11.43 106 91448 197138 90339755
Condition aggravated 26.37 11.43 433 91121 595112 89941781
Breast cancer 26.36 11.43 116 91438 53645 90483248
Product quality control issue 26.17 11.43 6 91548 22 90536871
Mucosal inflammation 25.74 11.43 13 91541 57612 90479281
Pulmonary function test decreased 25.68 11.43 27 91527 4467 90532426
Post-traumatic stress disorder 25.56 11.43 33 91521 6795 90530098
Nail disorder 25.39 11.43 14 91540 59053 90477840
Panic attack 25.26 11.43 71 91483 26294 90510599
Pulmonary mass 25.17 11.43 75 91479 28697 90508196
Interstitial lung disease 25.17 11.43 24 91530 76381 90460512
Electrocardiogram QT prolonged 24.76 11.43 22 91532 72434 90464459
Lip pruritus 24.65 11.43 16 91538 1344 90535549
Taste disorder 24.47 11.43 16 91538 61530 90475363
Suicide attempt 24.47 11.43 24 91530 75375 90461518
Pleuritic pain 23.82 11.43 40 91514 10421 90526472
Blood bilirubin increased 23.80 11.43 97 91457 43373 90493520
Bursitis 23.71 11.43 62 91492 131592 90405301
Increased upper airway secretion 23.51 11.43 24 91530 3837 90533056
Dust allergy 23.49 11.43 13 91541 816 90536077
Diaphragmatic rupture 23.48 11.43 9 91545 239 90536654
Pneumococcal infection 23.44 11.43 15 91539 1230 90535663
Injury 23.41 11.43 111 91443 197238 90339655
Hepatotoxicity 23.31 11.43 100 91454 45742 90491151
Cardio-respiratory arrest 23.02 11.43 18 91536 63122 90473771
Finger deformity 23.02 11.43 3 91551 32894 90503999
Flail chest 22.98 11.43 7 91547 90 90536803
Ureteral disorder 22.81 11.43 10 91544 377 90536516
Vital capacity decreased 22.66 11.43 17 91537 1802 90535091
Allergic sinusitis 22.51 11.43 18 91536 2095 90534798
Nasal dryness 22.51 11.43 28 91526 5555 90531338
Hyponatraemia 22.47 11.43 65 91489 133473 90403420
Exposure to allergen 22.40 11.43 11 91543 539 90536354
Injection site pain 22.31 11.43 271 91283 173428 90363465
Product availability issue 22.00 11.43 32 91522 7372 90529521
Contusion 21.92 11.43 156 91398 251060 90285833
Deformity 21.90 11.43 42 91512 12128 90524765
Malignant neoplasm progression 21.90 11.43 47 91507 106823 90430070
Impaired quality of life 21.85 11.43 62 91492 23082 90513811
Neutrophil count decreased 21.82 11.43 24 91530 71508 90465385
Allergy to animal 21.82 11.43 16 91538 1638 90535255
Encephalopathy 21.47 11.43 10 91544 46434 90490459
Enthesopathy 21.46 11.43 36 91518 9368 90527525
Tremor 21.45 11.43 243 91311 152930 90383963
Adiposis dolorosa 21.43 11.43 9 91545 305 90536588
Product administration error 21.36 11.43 67 91487 26356 90510537
Purpura senile 21.23 11.43 11 91543 604 90536289
Dry skin 21.16 11.43 157 91397 87916 90448977
Hypothalamic pituitary adrenal axis suppression 20.79 11.43 9 91545 329 90536564
Skin exfoliation 20.45 11.43 128 91426 67785 90469108
Influenza 20.45 11.43 223 91331 139041 90397852
White blood cell count decreased 20.40 11.43 93 91461 167016 90369877
Hepatitis 20.22 11.43 25 91529 70714 90466179
Croup infectious 20.09 11.43 11 91543 676 90536217
Blood urine present 20.08 11.43 50 91504 17228 90519665
Pharyngeal swelling 20.00 11.43 36 91518 9908 90526985
Skin burning sensation 19.97 11.43 54 91500 19557 90517336
Choking 19.80 11.43 40 91514 11993 90524900
Rhinalgia 19.77 11.43 18 91536 2500 90534393
Oedema 19.68 11.43 120 91434 200175 90336718
Skin fragility 19.65 11.43 12 91542 906 90535987
Influenza like illness 19.54 11.43 144 91410 80467 90456426
Product dosage form issue 19.52 11.43 5 91549 32 90536861
Stress 19.50 11.43 145 91409 81250 90455643
Anxiety 19.34 11.43 429 91125 309343 90227550
Walking aid user 19.15 11.43 6 91548 35500 90501393
Sepsis 19.13 11.43 105 91449 179709 90357184
Sneezing 19.09 11.43 70 91484 29799 90507094
Hepatic cytolysis 19.02 11.43 4 91550 30912 90505981
Tarsal tunnel syndrome 19.01 11.43 10 91544 567 90536326
Respiratory tract infection 18.83 11.43 113 91441 58965 90477928
Exercise tolerance decreased 18.71 11.43 30 91524 7521 90529372
Drug reaction with eosinophilia and systemic symptoms 18.57 11.43 10 91544 42748 90494145
Lung neoplasm 18.42 11.43 28 91526 6707 90530186
Dehydration 18.33 11.43 118 91436 194329 90342564
Hippocampal sclerosis 18.32 11.43 6 91548 99 90536794
Menstruation delayed 18.16 11.43 16 91538 2129 90534764
Skin atrophy 18.06 11.43 25 91529 5504 90531389
Obstruction 17.99 11.43 21 91533 3900 90532993
Snoring 17.99 11.43 24 91530 5102 90531791
Bronchitis chronic 17.87 11.43 23 91531 4720 90532173
Hypoacusis 17.57 11.43 65 91489 27785 90509108
Skin plaque 17.43 11.43 34 91520 9941 90526952
Pseudomonas infection 17.26 11.43 43 91511 14822 90522071
Sedation 17.23 11.43 14 91540 48157 90488736
Coeliac disease 17.19 11.43 12 91542 44598 90492295
Erythema marginatum 17.17 11.43 4 91550 16 90536877
Lipoma 17.17 11.43 18 91536 2968 90533925
Shock 17.14 11.43 4 91550 28774 90508119
Appetite disorder 17.03 11.43 32 91522 9101 90527792
Chills 16.98 11.43 206 91348 131775 90405118
Peritoneal perforation 16.97 11.43 6 91548 126 90536767
Ulcer 16.95 11.43 6 91548 32876 90504017
Suicidal ideation 16.81 11.43 130 91424 73725 90463168
Amnesia 16.70 11.43 55 91499 108450 90428443
Oral mucosal blistering 16.47 11.43 27 91527 6897 90529996
Nephrolithiasis 16.36 11.43 95 91459 48990 90487903
Perfume sensitivity 16.33 11.43 11 91543 984 90535909
Hepatic failure 16.24 11.43 10 91544 39718 90497175
Tongue pruritus 16.05 11.43 10 91544 783 90536110
Nasal mucosal disorder 16.02 11.43 14 91540 1843 90535050
Thoracic operation 15.96 11.43 6 91548 151 90536742
Hepatic function abnormal 15.88 11.43 14 91540 46274 90490619
Temporal lobe epilepsy 15.83 11.43 8 91546 417 90536476
Erythema of eyelid 15.76 11.43 18 91536 3265 90533628
Hyperlipidaemia 15.75 11.43 55 91499 22861 90514032
Intentional self-injury 15.74 11.43 5 91549 29329 90507564
Tenosynovitis 15.73 11.43 41 91513 14526 90522367
Rosacea 15.56 11.43 24 91530 5823 90531070
Hypocalcaemia 15.55 11.43 12 91542 42356 90494537
Genital blister 15.53 11.43 6 91548 163 90536730
Throat tightness 15.52 11.43 65 91489 29419 90507474
Osteoporosis 15.51 11.43 48 91506 96483 90440410
Paranasal sinus inflammation 15.36 11.43 9 91545 630 90536263
Procedural anxiety 15.34 11.43 10 91544 846 90536047
Bronchial irritation 15.31 11.43 4 91550 28 90536865
Vulvovaginal ulceration 15.31 11.43 4 91550 28 90536865
Eosinophil count abnormal 15.24 11.43 10 91544 856 90536037
Genital rash 15.18 11.43 9 91545 644 90536249
Pharyngeal oedema 15.12 11.43 39 91515 13732 90523161
Accident 15.05 11.43 26 91528 6928 90529965
Ulcer haemorrhage 15.02 11.43 4 91550 26317 90510576
Hypoaesthesia oral 14.93 11.43 42 91512 15558 90521335
Feeling cold 14.81 11.43 61 91493 27404 90509489
Hypophagia 14.76 11.43 9 91545 35928 90500965
Foetal exposure during pregnancy 14.74 11.43 13 91541 42962 90493931
Dystrophic calcification 14.73 11.43 6 91548 188 90536705
Limb injury 14.70 11.43 67 91487 31441 90505452
Aphonia 14.69 11.43 36 91518 12283 90524610
Feeling abnormal 14.67 11.43 244 91310 166991 90369902
Diaphragmatic paralysis 14.65 11.43 9 91545 687 90536206
Ear discomfort 14.57 11.43 32 91522 10168 90526725
Atrial flutter 14.52 11.43 33 91521 10725 90526168
Stress urinary incontinence 14.49 11.43 15 91539 2437 90534456
Blood immunoglobulin E decreased 14.49 11.43 6 91548 196 90536697
Arthralgia 14.49 11.43 641 90913 777881 89759012
Secretion discharge 14.44 11.43 42 91512 15854 90521039
Nephropathy 14.37 11.43 30 91524 9205 90527688
Lichenification 14.33 11.43 8 91546 511 90536382
Eosinophil count increased 14.31 11.43 37 91517 13044 90523849
Wound haemorrhage 14.24 11.43 16 91538 2851 90534042
Rhinitis perennial 14.23 11.43 4 91550 38 90536855
Renal failure 14.21 11.43 76 91478 130931 90405962
Depressed mood 14.10 11.43 93 91461 50129 90486764
Lung disorder 14.10 11.43 91 91463 149792 90387101
Focal segmental glomerulosclerosis 14.08 11.43 13 91541 1838 90535055
Blood iron decreased 14.03 11.43 45 91509 17914 90518979
Vestibular disorder 14.01 11.43 12 91542 1537 90535356
Product label confusion 13.96 11.43 3 91551 22847 90514046
Uterine polyp 13.96 11.43 15 91539 2545 90534348
Wrist fracture 13.93 11.43 41 91513 15583 90521310
Oropharyngeal oedema 13.92 11.43 7 91547 361 90536532
Exposure to fungus 13.84 11.43 6 91548 220 90536673
Mesenteric haemorrhage 13.78 11.43 4 91550 43 90536850
Asthmatic crisis 13.73 11.43 13 91541 1897 90534996
Lacrimation increased 13.73 11.43 59 91495 27003 90509890
Body temperature abnormal 13.69 11.43 15 91539 2600 90534293
Muscular weakness 13.67 11.43 138 91416 206528 90330365
Maternal exposure timing unspecified 13.64 11.43 3 91551 22480 90514413
Hyperaesthesia 13.54 11.43 32 91522 10670 90526223
Acute sinusitis 13.52 11.43 19 91535 4242 90532651
Frequent bowel movements 13.44 11.43 23 91531 56912 90479981
Diabetic ketoacidosis 13.38 11.43 4 91550 24403 90512490
Sputum purulent 13.31 11.43 11 91543 1341 90535552
Respiratory tract infection viral 13.25 11.43 16 91538 3080 90533813
Erythema 13.22 11.43 314 91240 228932 90307961
Periodic limb movement disorder 13.13 11.43 8 91546 602 90536291
Rash macular 13.11 11.43 63 91491 30217 90506676
Infection 12.96 11.43 273 91281 361821 90175072
Product leakage 12.92 11.43 11 91543 1397 90535496
Glossitis 12.90 11.43 17 91537 3570 90533323
Hyperglycaemia 12.90 11.43 92 91462 50878 90486015
Pneumocystis jirovecii pneumonia 12.88 11.43 3 91551 21613 90515280
Skin wrinkling 12.83 11.43 11 91543 1411 90535482
Cushing's syndrome 12.82 11.43 8 91546 628 90536265
Weight increased 12.75 11.43 323 91231 417604 90119289
Rash 12.73 11.43 666 90888 795434 89741459
Spirometry abnormal 12.71 11.43 6 91548 269 90536624
Eye swelling 12.62 11.43 61 91493 29325 90507568
Ecchymosis 12.61 11.43 34 91520 12289 90524604
Dry throat 12.55 11.43 26 91528 7934 90528959
Type 2 diabetes mellitus 12.52 11.43 138 91416 203106 90333787
Heart rate abnormal 12.50 11.43 22 91532 5949 90530944
Hypersensitivity 12.44 11.43 570 90984 454107 90082786
Gastrointestinal haemorrhage 12.39 11.43 48 91506 90200 90446693
Increased tendency to bruise 12.37 11.43 33 91521 11857 90525036
Menopause 12.35 11.43 16 91538 3305 90533588
Ocular hyperaemia 12.32 11.43 67 91487 33731 90503162
Bone hypertrophy 12.21 11.43 7 91547 470 90536423
Toxic epidermal necrolysis 12.21 11.43 9 91545 32519 90504374
Oropharyngeal spasm 12.18 11.43 6 91548 296 90536597
Intraocular pressure increased 12.18 11.43 24 91530 7069 90529824
Fractional exhaled nitric oxide increased 12.18 11.43 3 91551 16 90536877
Myxoedema 12.14 11.43 5 91549 161 90536732
Adrenal insufficiency 12.06 11.43 61 91493 29860 90507033
Rectal haemorrhage 12.02 11.43 43 91511 82701 90454192
Throat clearing 11.98 11.43 17 91537 3830 90533063
Colitis ulcerative 11.93 11.43 27 91527 60239 90476654
Hypomagnesaemia 11.93 11.43 11 91543 35577 90501316
Burns third degree 11.92 11.43 6 91548 310 90536583
Skin laceration 11.88 11.43 55 91499 25980 90510913
Respiratory tract irritation 11.84 11.43 7 91547 498 90536395
Change of bowel habit 11.79 11.43 13 91541 2270 90534623
Hypoglycaemia 11.74 11.43 34 91520 69814 90467079
Symptom recurrence 11.60 11.43 17 91537 3942 90532951
Ascites 11.53 11.43 19 91535 47721 90489172
Asthenia 11.51 11.43 432 91122 533319 90003574
Skin abrasion 11.50 11.43 31 91523 11204 90525689

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 2730.08 12.40 929 43510 16953 42559943
No adverse event 1708.54 12.40 826 43613 38195 42538701
Poor quality device used 1334.51 12.40 304 44135 1037 42575859
Product dose omission issue 906.43 12.40 951 43488 153414 42423482
Asthma 718.31 12.40 562 43877 61752 42515144
Wheezing 421.44 12.40 392 44047 54389 42522507
Product container issue 389.80 12.40 105 44334 809 42576087
Device malfunction 351.25 12.40 196 44243 12131 42564765
Cough 236.58 12.40 552 43887 177551 42399345
Circumstance or information capable of leading to medication error 223.44 12.40 88 44351 2440 42574456
Chest discomfort 210.67 12.40 294 44145 63322 42513574
Sleep disorder due to a general medical condition 210.62 12.40 162 44277 17291 42559605
Full blood count abnormal 207.11 12.40 202 44237 29674 42547222
Obstructive airways disorder 201.51 12.40 183 44256 24576 42552320
Dyspnoea 183.53 12.40 927 43512 441694 42135202
Nasal congestion 179.75 12.40 186 44253 29315 42547581
Nasal polyps 166.44 12.40 81 44358 3770 42573126
Fractional exhaled nitric oxide increased 156.33 12.40 60 44379 1549 42575347
Toxicity to various agents 133.36 12.40 37 44402 229099 42347797
Acute kidney injury 128.06 12.40 117 44322 367220 42209676
Productive cough 122.05 12.40 204 44235 51363 42525533
Sensation of foreign body 121.09 12.40 64 44375 3549 42573347
Plantar fasciitis 119.09 12.40 60 44379 3010 42573886
Myoglobin blood increased 114.36 12.40 62 44377 3620 42573276
Eosinophilic granulomatosis with polyangiitis 108.19 12.40 82 44357 8556 42568340
Off label use 107.48 12.40 327 44112 638008 41938888
Chronic sinusitis 99.50 12.40 55 44384 3337 42573559
Death 98.65 12.40 216 44223 470969 42105927
Therapeutic product effect incomplete 96.21 12.40 222 44217 70717 42506179
Sinusitis 91.13 12.40 171 44268 47121 42529775
Nasopharyngitis 89.79 12.40 240 44199 83756 42493140
Neutropenia 88.40 12.40 49 44390 199382 42377514
Thrombocytopenia 85.42 12.40 46 44393 190233 42386663
Dermatitis atopic 84.29 12.40 83 44356 12321 42564575
Hypersensitivity 83.71 12.40 213 44226 72157 42504739
Dust allergy 83.60 12.40 58 44381 5274 42571622
Drug abuse 83.12 12.40 7 44432 104764 42472132
Exostosis 83.05 12.40 59 44380 5572 42571324
Brain natriuretic peptide increased 81.99 12.40 63 44376 6707 42570189
Infective pulmonary exacerbation of cystic fibrosis 80.23 12.40 66 44373 7752 42569144
Dysphonia 77.47 12.40 120 44319 28330 42548566
Dyspnoea exertional 77.05 12.40 165 44274 49983 42526913
Rhinitis allergic 72.76 12.40 47 44392 3795 42573101
Steroid withdrawal syndrome 67.05 12.40 21 44418 288 42576608
Upper-airway cough syndrome 64.97 12.40 46 44393 4320 42572576
Completed suicide 63.16 12.40 12 44427 96453 42480443
Bronchopulmonary aspergillosis allergic 62.83 12.40 46 44393 4552 42572344
Allergy to animal 62.49 12.40 23 44416 527 42576369
Secretion discharge 61.23 12.40 56 44383 7579 42569317
Febrile neutropenia 58.96 12.40 64 44375 185639 42391257
Pleuritic pain 58.90 12.40 53 44386 7024 42569872
Nasal discomfort 58.68 12.40 30 44409 1552 42575344
Anosmia 55.85 12.40 45 44394 5131 42571765
Drug interaction 54.37 12.40 124 44315 266875 42310021
Anaemia 54.03 12.40 134 44305 280144 42296752
Cardiac disorder 52.43 12.40 140 44299 48792 42528104
Upper respiratory tract infection 51.75 12.40 127 44312 42046 42534850
Adjustment disorder 51.38 12.40 26 44413 1316 42575580
Gastrooesophageal reflux disease 49.44 12.40 130 44309 44893 42532003
Rhinitis perennial 49.13 12.40 15 44424 188 42576708
Device dislocation 48.79 12.40 50 44389 7781 42569115
Renal failure 48.48 12.40 47 44392 143679 42433217
Platelet count decreased 48.29 12.40 44 44395 138537 42438359
Poor quality product administered 48.11 12.40 30 44409 2278 42574618
Eosinophilia 45.71 12.40 104 44335 32795 42544101
Rhinorrhoea 44.72 12.40 101 44338 31693 42545203
Pancytopenia 43.93 12.40 35 44404 117708 42459188
Malignant neoplasm progression 43.31 12.40 30 44409 108370 42468526
Hyperkalaemia 43.12 12.40 15 44424 80443 42496453
Bronchial obstruction 42.55 12.40 25 44414 1704 42575192
Painful respiration 42.37 12.40 23 44416 1346 42575550
Sinus polyp 41.23 12.40 14 44425 251 42576645
Disease progression 40.80 12.40 54 44385 143602 42433294
Increased upper airway secretion 40.53 12.40 28 44411 2528 42574368
Loss of personal independence in daily activities 40.36 12.40 129 44310 49687 42527209
Pulmonary function test decreased 40.14 12.40 39 44400 5693 42571203
Incorrect dose administered 39.18 12.40 133 44306 52841 42524055
Seasonal allergy 38.95 12.40 45 44394 8010 42568886
Product taste abnormal 38.85 12.40 21 44418 1218 42575678
Sputum discoloured 38.31 12.40 50 44389 10082 42566814
Hepatic function abnormal 36.92 12.40 5 44434 51562 42525334
Underdose 36.84 12.40 64 44375 16602 42560294
Hypercholesterolaemia 36.09 12.40 55 44384 12794 42564102
Pleural thickening 36.00 12.40 15 44424 482 42576414
Respiratory tract congestion 35.64 12.40 42 44397 7636 42569260
Confusional state 34.75 12.40 77 44362 167520 42409376
Coronary artery disease 34.69 12.40 129 44310 53591 42523305
Enterocolitis infectious 34.48 12.40 23 44416 1960 42574936
Eosinophil count increased 34.46 12.40 49 44390 10714 42566182
Discomfort 34.23 12.40 79 44360 25140 42551756
Eosinophilic bronchitis 33.94 12.40 12 44427 244 42576652
Chest injury 33.79 12.40 22 44417 1800 42575096
Bradycardia 33.69 12.40 24 44415 85460 42491436
Respiratory symptom 33.28 12.40 49 44390 11057 42565839
Hypotension 33.17 12.40 147 44292 257484 42319412
Adrenal suppression 32.07 12.40 17 44422 948 42575948
Nasal disorder 31.84 12.40 22 44417 1987 42574909
Bronchospasm 31.83 12.40 52 44387 12833 42564063
Bronchial wall thickening 31.73 12.40 19 44420 1341 42575555
Sleep disorder 31.48 12.40 116 44323 47979 42528917
Diarrhoea 30.71 12.40 320 44119 460529 42116367
Spirometry abnormal 30.52 12.40 32 44407 5114 42571782
Cytokine release syndrome 30.30 12.40 5 44434 44522 42532374
Conjunctivitis allergic 30.24 12.40 34 44405 5877 42571019
Mycotic allergy 30.06 12.40 31 44408 4860 42572036
Septic shock 29.72 12.40 31 44408 91641 42485255
Interstitial lung disease 29.66 12.40 23 44416 78439 42498457
Cardio-respiratory arrest 29.63 12.40 12 44427 58624 42518272
Mastication disorder 29.45 12.40 20 44419 1756 42575140
Leukopenia 29.43 12.40 21 44418 74725 42502171
Chronic obstructive pulmonary disease 29.32 12.40 137 44302 62977 42513919
Mite allergy 29.25 12.40 31 44408 5015 42571881
Temperature intolerance 28.80 12.40 30 44409 4758 42572138
Vasculitis 28.78 12.40 61 44378 18333 42558563
Walking aid user 28.64 12.40 23 44416 2610 42574286
Obesity 28.60 12.40 57 44382 16402 42560494
Middle insomnia 28.60 12.40 38 44401 7795 42569101
Oropharyngeal pain 28.21 12.40 103 44336 42407 42534489
Ear infection 28.08 12.40 49 44390 12755 42564141
Foreign body in throat 28.01 12.40 13 44426 543 42576353
Forced expiratory volume decreased 27.84 12.40 37 44402 7593 42569303
Congenital hiatus hernia 27.38 12.40 33 44406 6141 42570755
Encephalopathy 27.34 12.40 5 44434 41328 42535568
Mast cell activation syndrome 27.20 12.40 11 44428 327 42576569
Bronchial irritation 26.95 12.40 7 44432 46 42576850
Oropharyngeal discomfort 26.77 12.40 27 44412 4122 42572774
Nasal oedema 26.74 12.40 11 44428 342 42576554
Increased viscosity of upper respiratory secretion 26.62 12.40 11 44428 346 42576550
Eczema 26.46 12.40 87 44352 33999 42542897
Ascites 26.43 12.40 13 44426 56665 42520231
Cardiac arrest 26.29 12.40 46 44393 109274 42467622
Throat irritation 26.17 12.40 48 44391 12988 42563908
Renal impairment 25.96 12.40 47 44392 110181 42466715
Metabolic acidosis 25.57 12.40 11 44428 51847 42525049
Skin plaque 25.45 12.40 31 44408 5832 42571064
Coma 25.41 12.40 12 44427 53542 42523354
Intentional overdose 25.24 12.40 11 44428 51445 42525451
Lactic acidosis 25.01 12.40 8 44431 45253 42531643
Infection parasitic 24.98 12.40 11 44428 406 42576490
Ear disorder 24.84 12.40 19 44420 2009 42574887
Myelosuppression 24.50 12.40 6 44433 40455 42536441
Central obesity 24.34 12.40 13 44426 736 42576160
Tachyarrhythmia 24.30 12.40 25 44414 3907 42572989
Breath sounds abnormal 23.61 12.40 44 44395 12049 42564847
Product quality control issue 23.47 12.40 4 44435 0 42576896
Joint warmth 23.22 12.40 12 44427 635 42576261
Anticoagulant therapy 23.05 12.40 26 44413 4509 42572387
Skin exfoliation 22.94 12.40 95 44344 41458 42535438
Oral candidiasis 22.80 12.40 48 44391 14357 42562539
Gastrointestinal haemorrhage 22.71 12.40 42 44397 97684 42479212
Product availability issue 22.63 12.40 23 44416 3544 42573352
Chorioretinopathy 22.48 12.40 16 44423 1515 42575381
Sleep apnoea syndrome 22.31 12.40 61 44378 21547 42555349
Haematochezia 22.25 12.40 17 44422 58419 42518477
Lung disorder 22.24 12.40 104 44335 47819 42529077
Clavicle fracture 22.14 12.40 20 44419 2663 42574233
Mucosal inflammation 22.02 12.40 12 44427 49362 42527534
Sneezing 21.91 12.40 30 44409 6333 42570563
Product odour abnormal 21.82 12.40 13 44426 909 42575987
Bronchitis 21.58 12.40 102 44337 47099 42529797
Sputum abnormal 21.37 12.40 11 44428 577 42576319
Prostate tenderness 21.35 12.40 6 44433 55 42576841
Stress 21.29 12.40 97 44342 44115 42532781
C-reactive protein increased 21.16 12.40 21 44418 63539 42513357
Tongue dry 21.13 12.40 9 44430 306 42576590
White blood cell count decreased 21.04 12.40 53 44386 110343 42466553
Lichenoid keratosis 20.68 12.40 23 44416 3927 42572969
Antacid therapy 20.57 12.40 25 44414 4692 42572204
Rhabdomyolysis 20.47 12.40 31 44408 77988 42498908
Lower respiratory tract infection 20.29 12.40 91 44348 41115 42535781
Aortic aneurysm 20.21 12.40 32 44407 7691 42569205
Crepitations 19.90 12.40 21 44418 3380 42573516
Haemoptysis 19.84 12.40 98 44341 46069 42530827
Respiratory arrest 19.77 12.40 3 44436 28421 42548475
Therapy non-responder 19.71 12.40 16 44423 53343 42523553
Gastrointestinal bacterial infection 19.71 12.40 11 44428 680 42576216
Myocardial infarction 19.64 12.40 65 44374 123944 42452952
Muscle spasms 19.52 12.40 155 44284 85889 42491007
Maple syrup disease 19.08 12.40 4 44435 8 42576888
Hypersomnia 18.97 12.40 45 44394 14573 42562323
Pyrexia 18.96 12.40 293 44146 393749 42183147
Multiple organ dysfunction syndrome 18.95 12.40 46 44393 96989 42479907
Hepatic failure 18.92 12.40 8 44431 38092 42538804
Influenza 18.75 12.40 120 44319 62055 42514841
Headache 18.74 12.40 352 44087 239017 42337879
Pulmonary eosinophilia 18.72 12.40 8 44431 274 42576622
Cockroach allergy 18.50 12.40 5 44434 39 42576857
Cystic fibrosis 18.31 12.40 16 44423 2039 42574857
Hot flush 18.20 12.40 58 44381 22293 42554603
Aspartate aminotransferase increased 18.07 12.40 33 44406 77130 42499766
Plasma cell myeloma 17.91 12.40 14 44425 47564 42529332
Sinus disorder 17.90 12.40 31 44408 8019 42568877
Cholestasis 17.83 12.40 6 44433 32873 42544023
Ejection fraction abnormal 17.79 12.40 13 44426 1282 42575614
Cytomegalovirus infection 17.34 12.40 6 44433 32300 42544596
Somnolence 17.24 12.40 82 44357 141023 42435873
Paraesthesia 17.03 12.40 133 44306 73326 42503570
Exercise lack of 16.97 12.40 6 44433 122 42576774
Dry skin 16.93 12.40 97 44342 48241 42528655
Haemoglobin decreased 16.76 12.40 76 44363 132395 42444501
Incorrect dose administered by product 16.73 12.40 5 44434 58 42576838
Sitting disability 16.68 12.40 7 44432 229 42576667
Pneumothorax 16.43 12.40 58 44381 23485 42553411
Scab 16.28 12.40 25 44414 5853 42571043
Overdose 16.10 12.40 56 44383 105208 42471688
Growth retardation 16.01 12.40 16 44423 2416 42574480
International normalised ratio increased 15.93 12.40 16 44423 48152 42528744
Sinus congestion 15.68 12.40 27 44412 6953 42569943
Nodule 15.64 12.40 38 44401 12496 42564400
Cardiac failure 15.58 12.40 58 44381 106798 42470098
Ventricular hypertrophy 15.53 12.40 22 44417 4794 42572102
Skin atrophy 15.51 12.40 16 44423 2509 42574387
Blood pressure decreased 15.47 12.40 23 44416 58309 42518587
Normochromic normocytic anaemia 15.36 12.40 31 44408 9000 42567896
Respiratory failure 15.34 12.40 75 44364 128057 42448839
Serotonin syndrome 15.32 12.40 4 44435 25841 42551055
Stomatitis 15.23 12.40 18 44421 50311 42526585
Neuritis 15.22 12.40 25 44414 6195 42570701
Drug reaction with eosinophilia and systemic symptoms 15.07 12.40 13 44426 42062 42534834
Contraindicated product administered 14.82 12.40 4 44435 25268 42551628
Drug therapy 14.76 12.40 25 44414 6355 42570541
Depressed level of consciousness 14.68 12.40 17 44422 47953 42528943
Angiomyolipoma 14.66 12.40 5 44434 91 42576805
Shock 14.64 12.40 6 44433 29115 42547781
Delirium 14.63 12.40 20 44419 52499 42524397
Ulcer 14.63 12.40 44 44395 16397 42560499
Neoplasm progression 14.54 12.40 6 44433 28994 42547902
Disseminated intravascular coagulation 14.39 12.40 4 44435 24790 42552106
Analgesic therapy 14.35 12.40 25 44414 6499 42570397
Snoring 14.09 12.40 19 44420 3954 42572942
Cardiogenic shock 14.04 12.40 10 44429 35630 42541266
Papillary renal cell carcinoma 13.93 12.40 7 44432 349 42576547
Sepsis 13.80 12.40 137 44302 199197 42377699
Feeling cold 13.77 12.40 37 44402 12936 42563960
Urinary tract infection 13.76 12.40 55 44384 99229 42477667
Therapeutic response shortened 13.73 12.40 38 44401 13516 42563380
Lung opacity 13.67 12.40 23 44416 5814 42571082
Anxiety 13.65 12.40 186 44253 118374 42458522
Erythema 13.49 12.40 173 44266 108620 42468276
Suicide attempt 13.41 12.40 17 44422 46083 42530813
Pruritus 13.21 12.40 273 44166 188498 42388398
Rheumatoid arthritis 13.03 12.40 15 44424 42425 42534471
Ill-defined disorder 13.01 12.40 42 44397 16254 42560642
Fungal disease carrier 13.00 12.40 7 44432 403 42576493
Oesophageal dilatation 12.97 12.40 6 44433 249 42576647
Lacrimation increased 12.95 12.40 34 44405 11724 42565172
Bronchiolitis 12.82 12.40 18 44421 3888 42573008
Osteonecrosis 12.76 12.40 41 44398 15824 42561072
Hepatic cytolysis 12.75 12.40 6 44433 26838 42550058
Urine flow decreased 12.73 12.40 11 44428 1382 42575514
Micturition urgency 12.69 12.40 34 44405 11864 42565032
Toxic epidermal necrolysis 12.68 12.40 6 44433 26744 42550152
Wrong technique in device usage process 12.66 12.40 15 44424 2742 42574154
Sputum increased 12.57 12.40 16 44423 3147 42573749
Pulmonary vasculitis 12.48 12.40 23 44416 6243 42570653
Hypokalaemia 12.48 12.40 36 44403 71685 42505211
Telangiectasia 12.47 12.40 10 44429 1132 42575764
Accidental overdose 12.47 12.40 7 44432 28323 42548573
Cataract 12.46 12.40 64 44375 30540 42546356

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
Poor quality device used 1919.51 10.58 465 106888 2398 110479548
Product quality issue 1369.52 10.58 882 106471 76417 110405529
Asthma 1111.72 10.58 1290 106063 249001 110232945
Rhinitis allergic 667.82 10.58 333 107020 17589 110464357
Gastrooesophageal reflux disease 610.61 10.58 811 106542 179165 110302781
Product dose omission issue 584.92 10.58 1088 106265 320694 110161252
Wheezing 558.06 10.58 936 106417 254294 110227652
Nasal polyps 488.05 10.58 244 107109 12956 110468990
Cough 482.38 10.58 1249 106104 460392 110021554
Device malfunction 458.01 10.58 294 107059 25264 110456682
No adverse event 438.02 10.58 444 106909 73395 110408551
Full blood count abnormal 399.91 10.58 373 106980 55679 110426267
Sputum discoloured 394.02 10.58 277 107076 27668 110454278
Sleep disorder due to a general medical condition 372.19 10.58 347 107006 51765 110430181
Productive cough 361.37 10.58 498 106855 113807 110368139
Obstructive airways disorder 332.86 10.58 309 107044 45840 110436106
Dyspnoea 331.93 10.58 2017 105336 1104855 109377091
Nasal congestion 319.41 10.58 434 106919 97848 110384098
Ejection fraction 312.41 10.58 115 107238 2840 110479106
Sensitisation 305.00 10.58 124 107229 4027 110477919
Polycystic ovaries 300.91 10.58 128 107225 4668 110477278
Blood test abnormal 286.71 10.58 231 107122 28323 110453623
Total lung capacity increased 276.89 10.58 123 107230 4989 110476957
Asthma-chronic obstructive pulmonary disease overlap syndrome 272.69 10.58 130 107223 6214 110475732
Bronchiectasis 272.20 10.58 249 107104 36244 110445702
Circumstance or information capable of leading to medication error 270.95 10.58 122 107231 5111 110476835
Dysphonia 256.92 10.58 342 107011 75587 110406359
Toxicity to various agents 239.16 10.58 84 107269 480471 110001475
Chest discomfort 239.05 10.58 524 106829 173324 110308622
Synovitis 230.35 10.58 8 107345 274084 110207862
Product container issue 230.02 10.58 78 107275 1502 110480444
Swelling face 226.39 10.58 357 106996 91964 110389982
Swollen tongue 224.66 10.58 285 107068 60077 110421869
Bronchopulmonary aspergillosis allergic 218.64 10.58 123 107230 8303 110473643
Sarcoidosis 194.50 10.58 132 107221 12447 110469499
Pemphigus 192.77 10.58 3 107350 214567 110267379
Completed suicide 187.81 10.58 12 107341 242369 110239577
Headache 182.27 10.58 1470 105883 880907 109601039
Sleep apnoea syndrome 181.53 10.58 210 107143 40237 110441709
Hand deformity 181.43 10.58 7 107346 218499 110263447
Acute kidney injury 181.34 10.58 210 107143 635220 109846726
Infective pulmonary exacerbation of cystic fibrosis 177.65 10.58 133 107220 14638 110467308
Anti-cyclic citrullinated peptide antibody positive 161.57 10.58 3 107350 181981 110299965
Pleural thickening 156.38 10.58 73 107280 3326 110478620
Systemic lupus erythematosus 156.01 10.58 29 107324 254309 110227637
Glossodynia 155.52 10.58 17 107336 221987 110259959
Helicobacter infection 153.87 10.58 5 107348 181872 110300074
Eosinophilic granulomatosis with polyangiitis 153.11 10.58 107 107246 10579 110471367
Pericarditis 152.93 10.58 17 107336 219097 110262849
Ejection fraction abnormal 149.01 10.58 71 107282 3389 110478557
Cardiac disorder 148.38 10.58 266 107087 76014 110405932
Cardiac murmur 147.62 10.58 149 107204 24479 110457467
Carpal tunnel syndrome 141.43 10.58 140 107213 22470 110459476
Presbyacusis 140.50 10.58 64 107289 2755 110479191
Contraindicated product administered 136.75 10.58 36 107317 248231 110233715
Steroid withdrawal syndrome 135.01 10.58 46 107307 899 110481047
Neutropenia 133.59 10.58 101 107252 374519 110107427
Chronic obstructive pulmonary disease 133.26 10.58 314 107039 108844 110373102
Upper-airway cough syndrome 125.71 10.58 112 107241 15745 110466201
Drug abuse 120.72 10.58 15 107338 177396 110304550
Folliculitis 119.57 10.58 12 107341 167641 110314305
Wound 118.20 10.58 40 107313 234397 110247549
Pleural fibrosis 117.53 10.58 65 107288 4243 110477703
Thrombocytopenia 116.95 10.58 100 107253 348785 110133161
Angioedema 116.62 10.58 280 107073 98220 110383726
Therapeutic product effect incomplete 113.35 10.58 474 106879 223331 110258615
Rhinorrhoea 113.22 10.58 284 107069 102382 110379564
Dermatitis atopic 111.91 10.58 131 107222 25410 110456536
Rales 110.25 10.58 128 107225 24611 110457335
Hypomania 109.76 10.58 86 107267 10124 110471822
Burning sensation 107.06 10.58 219 107134 68993 110412953
Muscle injury 106.06 10.58 8 107345 140799 110341147
Jaundice cholestatic 105.66 10.58 98 107255 14510 110467436
Nephrectomy 104.10 10.58 51 107302 2589 110479357
Confusional state 103.83 10.58 185 107168 468495 110013451
Infusion related reaction 103.25 10.58 131 107222 381031 110100915
Rheumatoid factor positive 100.52 10.58 7 107346 131633 110350313
Blood magnesium increased 99.71 10.58 56 107297 3767 110478179
Nasal discomfort 98.28 10.58 66 107287 6115 110475831
Impaired healing 96.69 10.58 35 107318 196682 110285264
Pneumonia aspiration 93.03 10.58 228 107125 81005 110400941
Oropharyngeal pain 91.21 10.58 314 107039 134962 110346984
Maternal exposure during pregnancy 90.46 10.58 69 107284 254814 110227132
Death 89.51 10.58 362 106991 698507 109783439
C-reactive protein increased 88.11 10.58 51 107302 217868 110264078
Loss of personal independence in daily activities 86.56 10.58 331 107022 149689 110332257
Deafness neurosensory 86.48 10.58 73 107280 9546 110472400
Sinus disorder 86.40 10.58 131 107222 32597 110449349
Dyspnoea exertional 83.18 10.58 256 107097 103804 110378142
Bronchial obstruction 82.75 10.58 46 107307 3033 110478913
Off label use 82.52 10.58 997 106356 1499188 108982758
Intentional overdose 81.45 10.58 15 107338 132486 110349460
Middle insomnia 81.37 10.58 100 107253 20402 110461544
Liver injury 80.57 10.58 23 107330 150390 110331556
Arthropathy 79.75 10.58 97 107256 287425 110194521
Drug interaction 79.58 10.58 236 107117 499947 109981999
Hypersensitivity 79.23 10.58 666 106687 403332 110078614
Anosmia 77.58 10.58 77 107276 12395 110469551
Total lung capacity decreased 76.64 10.58 60 107293 7054 110474892
Dust allergy 76.57 10.58 56 107297 5945 110476001
Bronchitis 75.15 10.58 327 107026 156705 110325241
Lip dry 74.49 10.58 6 107347 100077 110381869
Fractional exhaled nitric oxide increased 73.99 10.58 28 107325 748 110481198
Psoriatic arthropathy 72.75 10.58 51 107302 196710 110285236
Upper respiratory tract infection 71.88 10.58 285 107068 131043 110350903
Blood calcium increased 71.61 10.58 88 107265 17952 110463994
Lung neoplasm malignant 70.96 10.58 122 107231 33720 110448226
Hyperkalaemia 70.49 10.58 22 107331 135774 110346172
Epigastric discomfort 70.12 10.58 63 107290 8952 110472994
Cyst 67.96 10.58 82 107271 16414 110465532
Joint swelling 67.53 10.58 213 107140 442632 110039314
Irritable bowel syndrome 66.99 10.58 38 107315 164177 110317769
Heart sounds 66.75 10.58 29 107324 1114 110480832
Eczema 66.52 10.58 187 107166 72106 110409840
Sinusitis 65.70 10.58 503 106850 296185 110185761
Overdose 64.69 10.58 79 107274 233715 110248231
Pancytopenia 64.39 10.58 65 107288 209548 110272398
Myelosuppression 64.11 10.58 8 107345 94332 110387614
Platelet count decreased 63.62 10.58 78 107275 230365 110251581
Forced expiratory volume decreased 63.50 10.58 71 107282 13105 110468841
Therapy non-responder 63.32 10.58 37 107316 157270 110324676
Product taste abnormal 62.83 10.58 36 107317 2516 110479430
Joint range of motion decreased 62.77 10.58 20 107333 121812 110360134
Prolonged expiration 61.25 10.58 30 107323 1522 110480424
General physical health deterioration 61.09 10.58 210 107143 425085 110056861
Febrile neutropenia 60.68 10.58 136 107217 316631 110165315
Anaemia 60.56 10.58 299 107054 546787 109935159
Increased upper airway secretion 60.45 10.58 46 107307 5186 110476760
Haemoptysis 60.27 10.58 179 107174 71175 110410771
Peripheral venous disease 60.02 10.58 6 107347 84111 110397835
Schizophrenia 59.95 10.58 89 107264 21737 110460209
Sinus pain 59.93 10.58 48 107305 5831 110476115
Metabolic acidosis 59.80 10.58 12 107341 99732 110382214
Nasal disorder 59.73 10.58 42 107311 4192 110477754
Pleuritic pain 59.70 10.58 76 107277 16064 110465882
Grip strength decreased 59.13 10.58 5 107348 80169 110401777
Hypothyroidism 58.87 10.58 180 107173 72719 110409227
Osteopenia 58.77 10.58 89 107264 22120 110459826
Adrenal suppression 58.73 10.58 30 107323 1666 110480280
Leukopenia 58.48 10.58 36 107317 148755 110333191
Rhinitis perennial 56.59 10.58 17 107336 217 110481729
Pulmonary function test decreased 56.51 10.58 55 107298 8645 110473301
Bone cyst 56.15 10.58 38 107315 3565 110478381
Incorrect dose administered 55.97 10.58 224 107129 103417 110378529
Stomatitis 55.11 10.58 112 107241 270130 110211816
Seasonal allergy 55.00 10.58 81 107272 19641 110462305
Drug ineffective for unapproved indication 54.53 10.58 221 107132 102617 110379329
Abdominal discomfort 54.20 10.58 198 107155 393660 110088286
Lactic acidosis 53.93 10.58 12 107341 92799 110389147
Inflammation 53.76 10.58 65 107288 193173 110288773
Renal disorder 53.62 10.58 136 107217 49343 110432603
Lung opacity 53.11 10.58 61 107292 11591 110470355
Paranasal sinus discomfort 52.28 10.58 46 107307 6359 110475587
Rhinitis 52.24 10.58 85 107268 22460 110459486
Alopecia 51.76 10.58 181 107172 364572 110117374
Cholelithiasis 51.58 10.58 157 107196 63265 110418681
CFTR gene mutation 51.32 10.58 16 107337 233 110481713
Urinary tract discomfort 51.22 10.58 23 107330 957 110480989
Tunnel vision 51.15 10.58 29 107324 1986 110479960
Dry eye 51.01 10.58 144 107209 55649 110426297
Respiratory tract congestion 50.53 10.58 100 107253 30757 110451189
Night sweats 50.49 10.58 34 107319 133949 110347997
Eosinophil count increased 49.61 10.58 80 107273 20978 110460968
Live birth 49.46 10.58 5 107348 69479 110412467
Septic shock 49.35 10.58 48 107305 157480 110324466
Alveolar osteitis 48.98 10.58 23 107330 1062 110480884
Cardiac arrest 48.82 10.58 72 107281 196681 110285265
Swelling 48.61 10.58 176 107177 350865 110131081
Delirium 48.60 10.58 36 107317 134989 110346957
Osteosclerosis 48.46 10.58 38 107315 4477 110477469
Therapeutic product effect decreased 48.35 10.58 103 107250 244213 110237733
Aspiration 47.66 10.58 97 107256 30436 110451510
Respiration abnormal 47.52 10.58 53 107300 9756 110472190
Hypotension 47.29 10.58 306 107047 523543 109958403
Breast cancer 47.15 10.58 111 107242 38431 110443515
Cardio-respiratory arrest 46.96 10.58 27 107326 115809 110366137
Chronic sinusitis 46.88 10.58 86 107267 24998 110456948
Disease progression 46.54 10.58 105 107248 243929 110238017
Plantar fasciitis 46.45 10.58 39 107314 5062 110476884
Autoimmune disorder 45.87 10.58 5 107348 65478 110416468
Intentional product use issue 45.40 10.58 109 107244 247797 110234149
Animal scratch 45.17 10.58 26 107327 1833 110480113
Drug-induced liver injury 44.53 10.58 31 107322 120036 110361910
Throat irritation 43.96 10.58 133 107220 53419 110428527
Red blood cell sedimentation rate increased 43.77 10.58 11 107342 78291 110403655
Asthenopia 43.74 10.58 31 107322 3133 110478813
Interstitial lung disease 43.02 10.58 43 107310 139291 110342655
Encephalopathy 42.30 10.58 13 107340 81042 110400904
Renal failure 41.99 10.58 99 107254 226475 110255471
Dry skin 41.81 10.58 211 107142 107442 110374504
Bone marrow failure 41.60 10.58 4 107349 57844 110424102
Influenza 41.57 10.58 294 107059 168807 110313139
Wound infection 41.27 10.58 21 107332 96444 110385502
Hepatic function abnormal 40.41 10.58 18 107335 89277 110392669
Sciatica 39.70 10.58 20 107333 92379 110389567
Mucosal inflammation 39.56 10.58 22 107331 96119 110385827
Stress 39.19 10.58 204 107149 105144 110376802
Painful respiration 39.07 10.58 31 107322 3716 110478230
Mobility decreased 38.44 10.58 111 107242 237311 110244635
Mite allergy 38.28 10.58 37 107316 5766 110476180
Wrong technique in device usage process 38.18 10.58 40 107313 6861 110475085
Spirometry abnormal 38.07 10.58 36 107317 5461 110476485
Myalgia 38.05 10.58 356 106997 222025 110259921
Palpitations 37.51 10.58 274 107079 158938 110323008
Skin weeping 37.02 10.58 30 107323 3705 110478241
Epilepsy 36.99 10.58 26 107327 100183 110381763
Increased viscosity of upper respiratory secretion 36.79 10.58 16 107337 616 110481330
Sensation of foreign body 36.77 10.58 42 107311 7933 110474013
Lacrimation increased 36.63 10.58 88 107265 30862 110451084
Blister 36.31 10.58 107 107246 227269 110254677
Multiple organ dysfunction syndrome 36.20 10.58 57 107296 151653 110330293
Exposure during pregnancy 36.20 10.58 67 107286 167357 110314589
Prescribed overdose 36.10 10.58 20 107333 87561 110394385
Malignant neoplasm progression 35.88 10.58 72 107281 174495 110307451
Sinus polyp 35.87 10.58 16 107337 655 110481291
Road traffic accident 35.68 10.58 31 107322 107367 110374579
Mycotic allergy 35.63 10.58 36 107317 5918 110476028
Ear congestion 35.41 10.58 29 107324 3636 110478310
Sinus congestion 35.40 10.58 86 107267 30373 110451573
Vomiting 35.02 10.58 648 106705 910027 109571919
Dry mouth 34.21 10.58 91 107262 199857 110282089
Respiratory symptom 34.15 10.58 56 107297 14889 110467057
Onychomadesis 33.26 10.58 3 107350 45660 110436286
Electrocardiogram QT prolonged 33.21 10.58 34 107319 108926 110373020
Decreased appetite 33.00 10.58 299 107054 475547 110006399
Hip arthroplasty 32.87 10.58 7 107346 55806 110426140
Gait inability 32.77 10.58 51 107302 136325 110345621
Sneezing 32.68 10.58 86 107267 31898 110450048
Illness 32.57 10.58 162 107191 82009 110399937
Vaccination site pain 32.54 10.58 14 107339 525 110481421
Hepatic failure 32.48 10.58 13 107340 68726 110413220
Secretion discharge 32.42 10.58 65 107288 20179 110461767
Suicide attempt 31.81 10.58 32 107321 103362 110378584
Myoglobin blood increased 31.79 10.58 29 107324 4203 110477743
Allergy to animal 31.77 10.58 21 107332 1895 110480051
Adjustment disorder with depressed mood 31.65 10.58 3 107350 43880 110438066
Musculoskeletal pain 31.54 10.58 83 107270 182940 110299006
Poor quality product administered 31.39 10.58 30 107323 4611 110477335
Lower limb fracture 31.35 10.58 17 107336 75331 110406615
Knee arthroplasty 31.15 10.58 12 107341 64936 110417010
Bladder pain 30.96 10.58 24 107329 2781 110479165
Ascites 30.58 10.58 27 107326 92781 110389165
Bradycardia 30.39 10.58 66 107287 155451 110326495
Feeling cold 30.36 10.58 87 107266 33900 110448046
Temperature intolerance 30.18 10.58 51 107302 13899 110468047
Incorrect dose administered by product 30.17 10.58 11 107342 264 110481682
Neurotoxicity 30.14 10.58 3 107350 42204 110439742
Blepharospasm 30.09 10.58 8 107345 54843 110427103
Sleep disorder due to general medical condition, insomnia type 29.95 10.58 35 107318 105608 110376338
Treatment failure 29.78 10.58 153 107200 277081 110204865
Bronchial irritation 29.78 10.58 8 107345 66 110481880
Skin plaque 29.74 10.58 48 107305 12597 110469349
Prescribed underdose 29.71 10.58 13 107340 65161 110416785
Hepatic enzyme increased 29.66 10.58 186 107167 320706 110161240
Bronchospasm 29.57 10.58 80 107273 30159 110451787
Drug reaction with eosinophilia and systemic symptoms 29.39 10.58 22 107331 82073 110399873
Mouth breathing 28.99 10.58 11 107342 296 110481650
Congenital hiatus hernia 28.92 10.58 33 107320 6226 110475720
Cardiogenic shock 28.50 10.58 10 107343 57328 110424618
Pulmonary eosinophilia 27.87 10.58 14 107339 750 110481196
Product odour abnormal 27.83 10.58 18 107335 1565 110480381
Hypomagnesaemia 27.58 10.58 12 107341 60358 110421588
Shock 27.24 10.58 9 107344 53579 110428367
Skin exfoliation 26.79 10.58 161 107192 87490 110394456
Hepatic cytolysis 26.69 10.58 10 107343 55043 110426903
Sepsis 26.65 10.58 197 107156 327149 110154797
Psychotic disorder 26.62 10.58 109 107244 50828 110431118
Skin lesion 26.60 10.58 110 107243 51521 110430425
Memory impairment 26.42 10.58 100 107253 196844 110285102
Croup infectious 26.36 10.58 15 107338 1035 110480911
Anxiety 26.31 10.58 476 106877 344602 110137344
Diarrhoea 26.29 10.58 875 106478 1138630 109343316
Conjunctivitis allergic 26.21 10.58 33 107320 6898 110475048
Foreign body in throat 26.18 10.58 15 107338 1048 110480898
White blood cell count decreased 26.13 10.58 124 107229 229266 110252680
Bronchial wall thickening 26.11 10.58 23 107330 3184 110478762
Skin atrophy 26.02 10.58 32 107321 6532 110475414
Blood cholesterol increased 25.98 10.58 92 107261 184693 110297253
Exercise tolerance decreased 25.95 10.58 44 107309 12023 110469923
Pancreatitis relapsing 25.91 10.58 17 107336 1515 110480431
Product availability issue 25.84 10.58 35 107318 7855 110474091
Panic attack 25.78 10.58 74 107279 28866 110453080
Lip pruritus 25.66 10.58 16 107337 1306 110480640
Depressed mood 25.62 10.58 122 107231 60687 110421259
Cystic fibrosis 25.42 10.58 27 107326 4704 110477242
Prostate tenderness 25.41 10.58 7 107346 64 110481882
Lung perforation 25.38 10.58 8 107345 121 110481825
Rhabdomyolysis 25.30 10.58 49 107304 120352 110361594
Cytokine release syndrome 24.96 10.58 19 107334 70287 110411659
Gastrointestinal haemorrhage 24.92 10.58 80 107273 165438 110316508
Polymyalgia rheumatica 24.88 10.58 31 107322 6411 110475535
Pneumonia 24.87 10.58 1064 106289 875650 109606296
Hyperlipidaemia 24.83 10.58 84 107269 35764 110446182
Diaphragmatic rupture 24.76 10.58 9 107344 214 110481732
Disseminated intravascular coagulation 24.68 10.58 5 107348 41281 110440665
International normalised ratio increased 24.33 10.58 29 107324 86743 110395203
Dehydration 24.31 10.58 165 107188 279346 110202600
Growth retardation 24.05 10.58 20 107333 2562 110479384
Injection site pain 23.84 10.58 271 107082 177651 110304295
Central obesity 23.74 10.58 18 107335 2018 110479928
Allergic sinusitis 23.59 10.58 17 107336 1764 110480182
Pregnancy 23.57 10.58 10 107343 51057 110430889
Cholestasis 23.47 10.58 17 107336 64501 110417445
Hypothalamic pituitary adrenal axis suppression 23.43 10.58 12 107341 670 110481276
Perfume sensitivity 23.20 10.58 14 107339 1077 110480869
Deformity 23.12 10.58 38 107315 10122 110471824
Nasopharyngitis 23.10 10.58 523 106830 393838 110088108
Respiratory arrest 23.05 10.58 14 107339 58285 110423661
Heart rate increased 22.98 10.58 227 107126 143607 110338339
Pulmonary mass 22.91 10.58 84 107269 37217 110444729
Joint stiffness 22.84 10.58 19 107334 67224 110414722
Taste disorder 22.80 10.58 18 107335 65369 110416577
Tremor 22.74 10.58 298 107055 201934 110280012
Nasal mucosal disorder 22.74 10.58 17 107336 1866 110480080
Device dislocation 22.59 10.58 75 107278 31629 110450317
Exposure to allergen 22.53 10.58 11 107342 554 110481392
Calculus urinary 22.51 10.58 21 107332 3131 110478815
Skin fragility 22.43 10.58 14 107339 1144 110480802
Coma 22.35 10.58 193 107160 117676 110364270
Bursitis 22.32 10.58 59 107294 129859 110352087
Mastication disorder 22.29 10.58 22 107331 3516 110478430
Eosinophilic bronchitis 22.15 10.58 11 107342 575 110481371
Product use issue 21.96 10.58 195 107158 311500 110170446
Toxic epidermal necrolysis 21.90 10.58 14 107339 56713 110425233
Haematochezia 21.77 10.58 50 107303 115474 110366472
Adiposis dolorosa 21.77 10.58 9 107344 305 110481641
Breath sounds abnormal 21.70 10.58 64 107289 25340 110456606
Wound secretion 21.68 10.58 30 107323 6871 110475075
Cytomegalovirus infection 21.63 10.58 13 107340 54431 110427515
Hypoacusis 21.40 10.58 79 107274 35112 110446834
Vasculitis 21.37 10.58 80 107273 35793 110446153
Nasal dryness 21.31 10.58 27 107326 5679 110476267
Ear disorder 21.29 10.58 25 107328 4864 110477082
Altered state of consciousness 21.20 10.58 15 107338 57611 110424335
Rash macular 21.19 10.58 84 107269 38602 110443344
Chest injury 21.12 10.58 21 107332 3388 110478558
Drug level increased 21.00 10.58 10 107343 47709 110434237
Sedation 20.94 10.58 22 107331 69661 110412285
Respiratory failure 20.84 10.58 123 107230 215209 110266737
Skin burning sensation 20.61 10.58 57 107296 21768 110460178
Snoring 20.58 10.58 29 107324 6755 110475191
Throat clearing 20.28 10.58 23 107330 4310 110477636
Increased bronchial secretion 20.28 10.58 22 107331 3926 110478020
Hepatocellular injury 20.24 10.58 12 107341 50630 110431316
Tubulointerstitial nephritis 20.15 10.58 14 107339 54270 110427676
Rectal haemorrhage 20.15 10.58 55 107298 119778 110362168
Nail disorder 20.14 10.58 16 107337 57919 110424027
Choking 20.12 10.58 45 107308 15065 110466881
Oropharyngeal discomfort 20.05 10.58 36 107317 10291 110471655
Tumour lysis syndrome 20.01 10.58 3 107350 30798 110451148
Hypokalaemia 19.98 10.58 100 107253 182348 110299598
Cardiac failure 19.89 10.58 104 107249 187522 110294424
Liver disorder 19.88 10.58 71 107282 142172 110339774
Erythema 19.80 10.58 395 106958 291052 110190894
Post-traumatic stress disorder 19.72 10.58 28 107325 6568 110475378
Product administered to patient of inappropriate age 19.58 10.58 31 107322 8005 110473941
Anticoagulant therapy 19.44 10.58 25 107328 5336 110476610
Maple syrup disease 19.37 10.58 4 107349 8 110481938
Lichenoid keratosis 19.21 10.58 27 107326 6275 110475671
Ureteral disorder 19.13 10.58 10 107343 583 110481363
Epistaxis 19.03 10.58 202 107151 130170 110351776
Antacid therapy 18.99 10.58 25 107328 5459 110476487
Cognitive disorder 18.93 10.58 35 107318 87476 110394470
Blood potassium increased 18.86 10.58 73 107280 33176 110448770
Pneumococcal infection 18.86 10.58 15 107338 1804 110480142
Purpura senile 18.78 10.58 10 107343 605 110481341
Acute hepatic failure 18.76 10.58 6 107347 36462 110445484
Neoplasm progression 18.74 10.58 21 107332 64574 110417372
Eosinophilia 18.72 10.58 108 107245 57828 110424118
Flail chest 18.55 10.58 6 107347 99 110481847
Hepatic cirrhosis 18.53 10.58 23 107330 67603 110414343
Neutrophil count decreased 18.52 10.58 58 107295 120883 110361063
Acute myeloid leukaemia 18.35 10.58 7 107346 38103 110443843
Ill-defined disorder 18.32 10.58 84 107269 156769 110325177
Hospitalisation 18.18 10.58 215 107138 142278 110339668
Wound complication 18.14 10.58 26 107327 6151 110475795
Lung neoplasm 18.10 10.58 30 107323 8046 110473900
Chills 17.88 10.58 272 107081 190308 110291638
Sputum abnormal 17.83 10.58 13 107340 1373 110480573
Hepatotoxicity 17.83 10.58 114 107239 63286 110418660
Hepatitis 17.77 10.58 38 107315 90016 110391930
Throat tightness 17.77 10.58 72 107281 33417 110448529
Hyperbilirubinaemia 17.75 10.58 4 107349 30667 110451279
Cockroach allergy 17.67 10.58 6 107347 116 110481830
Coeliac disease 17.60 10.58 10 107343 43177 110438769
Renal tubular necrosis 17.58 10.58 4 107349 30471 110451475
Blood immunoglobulin E decreased 17.37 10.58 7 107346 222 110481724
Pharyngeal swelling 17.35 10.58 37 107316 11995 110469951
Erythema marginatum 17.33 10.58 4 107349 16 110481930
Hyponatraemia 17.22 10.58 132 107221 217521 110264425
Depressive symptom 17.20 10.58 30 107323 8384 110473562
Arteriosclerosis 17.12 10.58 58 107295 24709 110457237
Sopor 17.12 10.58 7 107346 36539 110445407
Wrist fracture 17.07 10.58 41 107312 14376 110467570
Tarsal tunnel syndrome 16.97 10.58 9 107344 540 110481406
Rheumatoid arthritis 16.75 10.58 198 107155 299415 110182531
Hereditary angioedema 16.72 10.58 27 107326 7087 110474859
Orthostatic hypotension 16.66 10.58 24 107329 66225 110415721
Anaphylactic reaction 16.64 10.58 177 107176 114123 110367823
Back injury 16.59 10.58 13 107340 47386 110434560
Skin wrinkling 16.52 10.58 13 107340 1540 110480406
Adrenal insufficiency 16.39 10.58 83 107270 42307 110439639
Depressed level of consciousness 16.39 10.58 55 107298 112223 110369723
Blood pressure increased 16.18 10.58 346 107007 258027 110223919
Vulvovaginal ulceration 16.14 10.58 4 107349 23 110481923
Foot deformity 16.09 10.58 14 107339 48466 110433480
Coronary artery disease 16.09 10.58 122 107231 71568 110410378
Scab 16.06 10.58 38 107315 13198 110468748
Forced expiratory volume abnormal 16.04 10.58 6 107347 155 110481791
Acquired haemophilia 15.91 10.58 16 107337 2615 110479331
Pneumocystis jirovecii pneumonia 15.89 10.58 11 107342 42724 110439222
Chorioretinopathy 15.83 10.58 15 107338 2280 110479666
Procedural anxiety 15.66 10.58 10 107343 851 110481095
Haemoglobin decreased 15.64 10.58 160 107193 248567 110233379
Ear discomfort 15.54 10.58 34 107319 11215 110470731
Impaired quality of life 15.50 10.58 64 107289 29953 110451993
Oral candidiasis 15.50 10.58 85 107268 44675 110437271
Hypersomnia 15.42 10.58 61 107292 28000 110453946
Diabetic ketoacidosis 15.41 10.58 11 107342 42047 110439899
Lymphopenia 15.39 10.58 10 107343 40160 110441786
Oedema 15.39 10.58 130 107223 209846 110272100
Peritoneal perforation 15.36 10.58 6 107347 175 110481771
Infection parasitic 15.31 10.58 10 107343 884 110481062
Dystrophic calcification 15.30 10.58 6 107347 177 110481769
Lipoma 15.22 10.58 19 107334 3936 110478010
Appetite disorder 15.20 10.58 31 107322 9738 110472208
Dry throat 15.20 10.58 30 107323 9208 110472738
Gout 15.14 10.58 73 107280 36493 110445453
Condition aggravated 15.12 10.58 572 106781 734264 109747682
Exostosis 15.07 10.58 86 107267 45870 110436076
Burns third degree 15.01 10.58 8 107345 485 110481461
Peripheral swelling 15.01 10.58 289 107064 403745 110078201
Cushing's syndrome 14.95 10.58 10 107343 920 110481026
Aortic aneurysm 14.91 10.58 31 107322 9873 110472073
Expired product administered 14.89 10.58 28 107325 8292 110473654
Cerebral infarction 14.88 10.58 17 107336 51821 110430125
Clavicle fracture 14.85 10.58 22 107331 5362 110476584
Intentional self-injury 14.78 10.58 9 107344 37420 110444526
Thrombotic microangiopathy 14.63 10.58 5 107348 29144 110452802
Neuritis 14.63 10.58 26 107327 7373 110474573
Pharyngeal oedema 14.62 10.58 42 107311 16386 110465560
Respiratory tract infection 14.49 10.58 119 107234 71498 110410448
Hearing disability 14.48 10.58 4 107349 37 110481909
Telangiectasia 14.37 10.58 13 107340 1864 110480082
Bacteraemia 14.37 10.58 12 107341 42378 110439568
Neutropenic sepsis 14.22 10.58 6 107347 30740 110451206
Papillary renal cell carcinoma 14.17 10.58 7 107346 362 110481584
Genital blister 14.12 10.58 6 107347 218 110481728
Hot flush 14.06 10.58 111 107242 65925 110416021
Hidradenitis 14.05 10.58 21 107332 5159 110476787
Pain 14.05 10.58 771 106582 954184 109527762
Urticaria 14.00 10.58 407 106946 318450 110163496
Symptom recurrence 13.89 10.58 20 107333 4752 110477194
Genital rash 13.82 10.58 11 107342 1324 110480622
Benign prostatic hyperplasia 13.77 10.58 44 107309 18190 110463756
Sputum increased 13.75 10.58 22 107331 5729 110476217
Cytopenia 13.74 10.58 6 107347 30110 110451836
Eye swelling 13.70 10.58 66 107287 32982 110448964
Analgesic therapy 13.65 10.58 25 107328 7259 110474687
Drug therapy 13.63 10.58 25 107328 7266 110474680
Drug resistance 13.62 10.58 21 107332 56353 110425593
Chronic rhinosinusitis with nasal polyps 13.60 10.58 5 107348 123 110481823
Aphonia 13.57 10.58 35 107318 12825 110469121
Pyrexia 13.44 10.58 724 106629 897541 109584405
Subarachnoid haemorrhage 13.42 10.58 6 107347 29696 110452250
Brain natriuretic peptide increased 13.40 10.58 32 107321 11177 110470769
Colitis ulcerative 13.39 10.58 35 107318 77328 110404618
Oral mucosal blistering 13.34 10.58 26 107327 7908 110474038
Nasal discharge discolouration 13.33 10.58 16 107337 3185 110478761
Feeling abnormal 13.31 10.58 248 107105 180463 110301483
Eye pruritus 13.26 10.58 65 107288 32710 110449236
Gastrointestinal bacterial infection 13.24 10.58 11 107342 1407 110480539
Haemodynamic instability 13.21 10.58 3 107350 22885 110459061
Enthesopathy 13.21 10.58 34 107319 12444 110469502
Malnutrition 13.15 10.58 5 107348 27274 110454672
Shock haemorrhagic 13.12 10.58 5 107348 27242 110454704
Injection site bruising 13.10 10.58 90 107263 51173 110430773
Underdose 13.08 10.58 106 107247 63448 110418498
Sleep disorder 13.08 10.58 268 107085 198376 110283570
Tongue pruritus 13.07 10.58 9 107344 869 110481077
Progressive multifocal leukoencephalopathy 13.02 10.58 4 107349 24952 110456994
Brain oedema 12.96 10.58 7 107346 31091 110450855
Conjunctivitis 12.95 10.58 66 107287 33726 110448220
Pulmonary vasculitis 12.91 10.58 23 107330 6537 110475409
Somnolence 12.87 10.58 379 106974 297070 110184876
Thoracic operation 12.86 10.58 6 107347 273 110481673
Product quality control issue 12.81 10.58 3 107350 13 110481933
Breast conserving surgery 12.80 10.58 9 107344 898 110481048
Ear pain 12.76 10.58 92 107261 53134 110428812
Transplant rejection 12.71 10.58 4 107349 24563 110457383
Tachyarrhythmia 12.60 10.58 26 107327 8235 110473711
Dermatitis allergic 12.57 10.58 48 107305 21676 110460270
Flank pain 12.49 10.58 50 107303 23080 110458866
Rosacea 12.48 10.58 20 107333 5216 110476730
Sitting disability 12.45 10.58 7 107346 472 110481474
Obstruction 12.40 10.58 21 107332 5731 110476215
Intertrigo 12.39 10.58 10 107343 1228 110480718
Lip swelling 12.39 10.58 88 107265 50579 110431367
Contusion 12.36 10.58 156 107197 233205 110248741
Hepatic encephalopathy 12.31 10.58 6 107347 28250 110453696
Infection 12.28 10.58 263 107090 361937 110120009
Palmar-plantar erythrodysaesthesia syndrome 12.27 10.58 13 107340 41012 110440934
Rhinalgia 12.22 10.58 17 107336 3912 110478034
Posterior reversible encephalopathy syndrome 12.22 10.58 9 107344 33852 110448094
Respiratory depression 12.21 10.58 8 107345 31993 110449953
Therapeutic response shortened 12.20 10.58 59 107294 29524 110452422
Coagulopathy 12.20 10.58 13 107340 40898 110441048
Nasal polypectomy 12.15 10.58 4 107349 70 110481876
Plasma cell myeloma 12.05 10.58 27 107326 62909 110419037
Sleep disorder therapy 11.98 10.58 24 107329 7447 110474499
Blood immunoglobulin E increased 11.95 10.58 24 107329 7458 110474488
Lichenification 11.94 10.58 9 107344 1000 110480946
Status epilepticus 11.91 10.58 8 107345 31563 110450383
Inappropriate schedule of product administration 11.88 10.58 270 107083 203367 110278579
Blood pressure systolic increased 11.84 10.58 128 107225 82863 110399083
Hand-foot-and-mouth disease 11.81 10.58 8 107345 752 110481194
Hypocalcaemia 11.75 10.58 29 107324 65337 110416609
Unresponsive to stimuli 11.71 10.58 28 107325 63762 110418184
Tongue dry 11.70 10.58 10 107343 1330 110480616
Hypercalcaemia 11.64 10.58 17 107336 46640 110435306
Eosinophil count abnormal 11.44 10.58 9 107344 1065 110480881
Amnesia 11.41 10.58 58 107295 105350 110376596
Joint warmth 11.40 10.58 12 107341 2070 110479876
Change of bowel habit 11.39 10.58 14 107339 2855 110479091
Circulatory collapse 11.39 10.58 15 107338 42978 110438968
Aspartate aminotransferase increased 11.28 10.58 100 107253 159836 110322110
Normochromic normocytic anaemia 11.25 10.58 33 107320 13024 110468922
Suicidal ideation 11.22 10.58 140 107213 93797 110388149
Blood urine present 11.21 10.58 50 107303 24195 110457751
Mesenteric haemorrhage 11.17 10.58 4 107349 91 110481855
Injury 11.15 10.58 114 107239 177151 110304795
Torsade de pointes 11.13 10.58 4 107349 22596 110459350
Enterococcal infection 11.12 10.58 3 107350 20363 110461583
Tinea versicolour 11.10 10.58 7 107346 583 110481363
Frequent bowel movements 11.10 10.58 34 107319 71356 110410590
Menopause 11.09 10.58 13 107340 2525 110479421
Vertebral end plate inflammation 11.07 10.58 5 107348 211 110481735
Menstruation delayed 11.02 10.58 11 107342 1783 110480163
Nasal oedema 11.00 10.58 22 107331 6817 110475129
Vision blurred 10.91 10.58 181 107172 128841 110353105
Hypoglycaemia 10.87 10.58 67 107286 116037 110365909
Hypothermia 10.85 10.58 6 107347 26296 110455650
Social fear 10.84 10.58 3 107350 28 110481918
Oesophageal dilatation 10.81 10.58 7 107346 610 110481336
Vestibular disorder 10.71 10.58 13 107340 2619 110479327
Pharyngeal erythema 10.69 10.58 12 107341 2223 110479723
Periarthritis 10.69 10.58 16 107337 3934 110478012

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 D000893 Anti-Inflammatory Agents
MeSH PA D003879 Dermatologic Agents
MeSH PA D018926 Anti-Allergic Agents
CHEBI has role CHEBI:35472 anti-inflammatory drug
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:50514 vasoconstrictor agent
CHEBI has role CHEBI:50857 anti-allergic agent
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:77715 nasal decongestant

Related Drugs by ATC class:

D07AC Corticosteroids, potent (group III) 20 drugs
amcinonidebeclometasone dipropionatebetamethasonebudesonidedesoximetasonediflorasone diacetatediflucortolonedifluprednatefluclorolonefludroxycortidefluocinolone acetonidefluocinonide show all 20 →
D07XC Corticosteroids, potent, other combinations 4 drugs
betamethasonedesoximetasonediflucortolonefluocortolone
R01AD Corticosteroids 12 drugs
beclometasone dipropionatebetamethasonebudesonideciclesonidedexamethasoneflunisolidefluticasone furoatefluticasone propionatehydrocortisoneprednisolonetixocortoltriamcinolone
R03AK Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics 13 drugs
beclometasone dipropionatebudesonidecromoglicic acidepinephrinefluticasone furoatefluticasone propionateformoterolindacaterolisoprenalinereproterolsalbutamolsalmeterol show all 13 →
R03AL Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids 14 drugs
aclidinium bromidebeclometasone dipropionatebudesonidefenoterolfluticasone furoateformoterolglycopyrronium bromideindacaterolipratropiumolodaterolsalbutamoltiotropium bromide show all 14 →
R03BA Glucocorticoids 8 drugs
beclometasone dipropionatebetamethasonebudesonideciclesonideflunisolidefluticasone furoatefluticasone propionatetriamcinolone

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 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 SPECLT 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 SPECLT 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 SPECLT 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 SPECLT 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 SPECLT 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 SPECLT 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 SPECLT 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 SPECLT N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 12064442 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 SPECLT 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 SPECLT 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)

None

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
MOF PDB_CHEM_ID
CHEMBL1161 ChEMBL_ID
D000068656 MESH_DESCRIPTOR_UI
DB14512 DRUGBANK_ID
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
CHEMBL1201404 ChEMBL_ID
141646-00-6 SECONDARY_CAS_RN
105102-22-5 SECONDARY_CAS_RN
441335 PUBCHEM_CID
9029 IUPHAR_LIGAND_ID
6030 INN_ID
8HR4QJ6DW8 UNII
CHEBI:6970 CHEBI
04201GDN4R INXIGHT DRUGS
8HR4QJ6DW8 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Nasonex HUMAN OTC DRUG LABEL 1 0113-1720 SPRAY, METERED 50 ug NASAL NDA 17 sections
Childrens Nasonex HUMAN OTC DRUG LABEL 1 0113-1999 SPRAY, METERED 50 ug NASAL NDA 17 sections
allergy nasal HUMAN OTC DRUG LABEL 1 0363-2060 SPRAY, METERED 50 ug NASAL NDA 17 sections
Rugby mometasone furoate nasal HUMAN OTC DRUG LABEL 1 0536-1381 SPRAY, METERED 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 0713-0635 OINTMENT 1 mg TOPICAL ANDA 24 sections
Sinuva HUMAN PRESCRIPTION DRUG LABEL 1 10599-003 IMPLANT 1350 ug INTRASINAL NDA 29 sections
Allergy HUMAN OTC DRUG LABEL 1 11822-7099 SPRAY, METERED 50 ug NASAL NDA 17 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 21695-786 CREAM 1 mg TOPICAL ANDA 13 sections
Mometasone furoate HUMAN PRESCRIPTION DRUG LABEL 1 21922-071 OINTMENT 1 mg TOPICAL ANDA 18 sections
MOMETASONE FUROATE HUMAN PRESCRIPTION DRUG LABEL 1 21922-072 LOTION 1 mg TOPICAL ANDA 26 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 42254-175 OINTMENT 1 mg TOPICAL ANDA 13 sections
allergy HUMAN OTC DRUG LABEL 1 42507-182 SPRAY, METERED 50 ug NASAL NDA 17 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 45802-118 SOLUTION 1 mg TOPICAL ANDA 26 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 45802-119 OINTMENT 1 mg TOPICAL ANDA 28 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 45802-257 CREAM 1 mg TOPICAL ANDA 28 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 50090-1026 OINTMENT 1 mg TOPICAL ANDA 26 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 50090-1633 OINTMENT 1 mg TOPICAL ANDA 28 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 50090-2179 CREAM 1 mg TOPICAL ANDA 25 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 50090-2991 CREAM 1 mg TOPICAL ANDA 27 sections
allergy HUMAN OTC DRUG LABEL 1 51316-117 SPRAY, METERED 50 ug NASAL NDA 17 sections
ALLERGY RELIEF HUMAN OTC DRUG LABEL 1 51316-172 SPRAY, METERED 50 ug NASAL NDA 17 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 51672-1315 CREAM 1 mg TOPICAL ANDA 29 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 53002-8320 CREAM 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 53002-8321 CREAM 1 mg TOPICAL ANDA 28 sections
Elocon HUMAN PRESCRIPTION DRUG LABEL 1 54868-2223 CREAM 1 mg TOPICAL NDA 10 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 54868-3757 SOLUTION 1 mg TOPICAL ANDA 20 sections
NASONEX HUMAN PRESCRIPTION DRUG LABEL 1 54868-4174 SPRAY, METERED 50 ug NASAL NDA 30 sections