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

Stem definitionDrug idCAS RN
steroids not used as glucocorticosteroids 1225 80474-14-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fluticasone proprionate
  • fluticasone propionate
  • flixotide
  • fluticasone 17-propionate
A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS. It has received approval to be used in combination with salmeterol.
  • Molecular weight: 500.57
  • Formula: C25H31F3O5S
  • CLOGP: 4.03
  • LIPINSKI: 1
  • HAC: 5
  • HDO: 1
  • TPSA: 80.67
  • ALOGS: -4.64
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.20 mg N
0.60 mg Inhal.aerosol
0.60 mg Inhal.powder
1.50 mg Inhal.solution

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 0.00 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 3 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.65 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 1 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 3.60 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 17 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.10 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 6 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.759 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.045 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 63.826 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 50.816 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 0.830 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 1.900 % High 1
herg hERG pIC50 4.867 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 92.470 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 257.040 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 1.320 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PRKDC,STK33,TEK,ZAP70 24
kinase-selectivity-class GRK2,MAP2K6 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 1.337 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 5.117 High 1
mh-clint Mouse hepatocyte intrinsic clearance 107.647 High 1
mppb Mouse plasma protein binding (% unbound) 1.090 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 28.184 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 1.620 % High 1
rat-kpuu-brain Rat brain Kpuu 0.557 % High 1
rh-clint Rat hepatocyte intrinsic clearance 133.045 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 7.530 % High 1
rppb Rat plasma protein binding (% unbound) 0.980 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 15.066 uM High 1

Approvals:

DateAgencyCompanyOrphan
March 26, 2021 EMA TEVA B.V.
Dec. 14, 1990 FDA FOUGERA PHARMS
June 29, 2020 PMDA Kyorin Pharmaceutical Co., Ltd.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 1015.38 9.45 1717 169585 240443 90216702
Cough 435.98 9.45 1609 169693 367353 90089792
Food allergy 386.69 9.45 347 170955 25131 90432014
Pemphigus 361.10 9.45 87 171215 326777 90130368
Hand deformity 339.11 9.45 73 171229 296289 90160856
Systemic lupus erythematosus 319.65 9.45 142 171160 361754 90095391
Toxicity to various agents 319.12 9.45 76 171226 287770 90169375
Macular degeneration 294.18 9.45 361 170941 37609 90419536
Synovitis 288.66 9.45 131 171171 329621 90127524
Glossodynia 287.71 9.45 124 171178 321655 90135490
Upper respiratory tract infection 263.10 9.45 679 170623 127639 90329506
Completed suicide 257.85 9.45 3 171299 145055 90312090
Immunodeficiency 229.50 9.45 342 170960 42892 90414253
Wound 226.31 9.45 147 171155 302833 90154312
Arthropathy 217.29 9.45 223 171079 366019 90091126
Temperature regulation disorder 216.17 9.45 196 171106 14383 90442762
Chest discomfort 215.74 9.45 663 170639 137702 90319443
Dyspnoea 214.69 9.45 2574 168728 878381 89578764
Anti-cyclic citrullinated peptide antibody positive 214.65 9.45 89 171213 236344 90220801
Chronic sinusitis 206.91 9.45 240 171062 23562 90433583
Pericarditis 203.20 9.45 130 171172 270021 90187124
Helicobacter infection 197.06 9.45 91 171211 226759 90230386
Nasal congestion 195.87 9.45 465 170837 82949 90374196
Duodenal ulcer perforation 194.98 9.45 87 171215 221201 90235944
General physical health deterioration 194.39 9.45 231 171071 354884 90102261
Infective pulmonary exacerbation of cystic fibrosis 188.45 9.45 156 171146 10123 90447022
Alopecia 185.77 9.45 413 170889 494658 89962487
Bronchitis 185.26 9.45 673 170629 152254 90304891
Foetal death 183.57 9.45 211 171091 20512 90436633
Wheezing 182.85 9.45 912 170390 237168 90219977
Product dose omission issue 174.61 9.45 1044 170258 290643 90166502
Rash erythematous 163.87 9.45 373 170929 64731 90392414
Hyperhidrosis 160.99 9.45 595 170707 135710 90321435
Sleep disorder due to general medical condition, insomnia type 159.25 9.45 26 171276 128668 90328477
Chronic obstructive pulmonary disease 153.65 9.45 393 170909 73436 90383709
Folliculitis 144.72 9.45 105 171197 204248 90252897
Muscle injury 142.67 9.45 78 171224 176576 90280569
Female genital tract fistula 140.19 9.45 171 171131 17697 90439448
Dermatitis atopic 139.62 9.45 196 171106 23276 90433869
Maternal exposure during pregnancy 136.90 9.45 298 171004 359765 90097380
Impaired healing 134.98 9.45 146 171156 234053 90223092
Acute kidney injury 134.77 9.45 250 171052 320137 90137008
Headache 133.97 9.45 2331 168971 860415 89596730
Obstructive airways disorder 133.52 9.45 202 171100 25667 90431478
Discomfort 133.13 9.45 195 171107 274140 90183005
Liver injury 128.30 9.45 82 171220 170485 90286660
Swollen joint count increased 127.89 9.45 27 171275 111179 90345966
Drug interaction 126.96 9.45 204 171098 276249 90180896
Therapeutic product effect decreased 126.37 9.45 206 171096 277365 90179780
Musculoskeletal stiffness 125.05 9.45 231 171071 296301 90160844
Neutropenia 123.30 9.45 146 171156 224758 90232387
Blister 122.03 9.45 183 171119 254815 90202330
Swelling 119.25 9.45 400 170902 418658 90038487
Productive cough 118.87 9.45 368 170934 76695 90380450
Sinusitis 117.36 9.45 1075 170227 342013 90115132
Ill-defined disorder 116 9.45 107 171195 184784 90272361
Confusional state 115.90 9.45 360 170942 385845 90071300
Sleep apnoea syndrome 115.65 9.45 212 171090 31535 90425610
Intentional product misuse 114.15 9.45 401 170901 89203 90367942
Fluid retention 110.30 9.45 392 170910 87699 90369446
Vaginal flatulence 109.11 9.45 127 171175 12511 90444634
Eosinophilic granulomatosis with polyangiitis 106.81 9.45 64 171238 2466 90454679
Illness 106.29 9.45 369 170933 81600 90375545
Gastrointestinal disorder 105.54 9.45 203 171099 256484 90200661
Radiculopathy 101.95 9.45 149 171153 18356 90438789
Paraesthesia oral 101.23 9.45 200 171102 31459 90425686
Abdominal discomfort 100.60 9.45 512 170790 476816 89980329
Seasonal allergy 100.02 9.45 166 171136 22817 90434328
Procedural pain 99.81 9.45 205 171097 33155 90423990
Intentional overdose 99.60 9.45 27 171275 93807 90363338
Proctitis 99.17 9.45 133 171169 15126 90442019
Dysphonia 98.92 9.45 303 170999 62781 90394364
Irritable bowel syndrome 98.15 9.45 150 171152 207298 90249847
Injection site pain 97.68 9.45 612 170690 173087 90284058
Contraindicated product administered 95.60 9.45 299 171003 319840 90137305
Febrile neutropenia 95.41 9.45 95 171207 158254 90298891
Impaired quality of life 95.19 9.45 163 171139 22981 90434164
Sputum increased 92.79 9.45 62 171240 2895 90454250
Oral candidiasis 92.40 9.45 206 171096 35249 90421896
Type 2 diabetes mellitus 92.32 9.45 151 171151 203093 90254052
Drug-induced liver injury 92.16 9.45 28 171274 90290 90366855
Rheumatic fever 92.10 9.45 92 171210 153029 90304116
Rheumatoid factor positive 91.34 9.45 114 171188 171536 90285609
Eczema 88.62 9.45 260 171042 52610 90404535
Vaginal discharge 87.96 9.45 143 171159 19321 90437824
Oropharyngeal pain 85.33 9.45 437 170865 114750 90342395
Mobility decreased 83.75 9.45 222 171080 250512 90206633
Malignant neoplasm progression 82.26 9.45 50 171252 106820 90350325
Feeling abnormal 81.17 9.45 568 170734 166667 90290478
Product quality issue 81.15 9.45 331 170971 78994 90378151
Psoriatic arthropathy 80.25 9.45 197 171105 228138 90229007
Myelosuppression 78.36 9.45 6 171296 53585 90403560
Product administration interrupted 78.32 9.45 107 171195 12385 90444760
Bronchial neoplasm 76.40 9.45 31 171271 499 90456646
Pancytopenia 74.94 9.45 70 171232 120193 90336952
Anosmia 72.04 9.45 91 171211 9757 90447388
Therapy non-responder 71.47 9.45 92 171210 136612 90320533
Bronchial haemorrhage 70.17 9.45 31 171271 622 90456523
Drug abuse 69.97 9.45 34 171268 82313 90374832
COVID-19 69.20 9.45 551 170751 168292 90288853
Nasal turbinate hypertrophy 68.79 9.45 34 171268 887 90456258
Pneumonia 68.20 9.45 1632 169670 636427 89820718
Nasal polyps 67.92 9.45 93 171209 10787 90446358
Rhonchi 67.03 9.45 51 171251 2927 90454218
Deep vein thrombosis postoperative 66.93 9.45 25 171277 70784 90386361
Upper-airway cough syndrome 66.78 9.45 110 171192 15025 90442120
Respiratory tract infection 66.47 9.45 254 171048 58824 90398321
Rhinitis 65.85 9.45 103 171199 13469 90443676
Gastrointestinal procedural complication 65.42 9.45 27 171275 455 90456690
Influenza 65.24 9.45 469 170833 138795 90318350
Forced expiratory volume decreased 65.18 9.45 67 171235 5741 90451404
Sleep disorder due to a general medical condition 64.72 9.45 209 171093 44529 90412616
Delirium 64.72 9.45 61 171241 104298 90352847
Coeliac disease 63.27 9.45 207 171095 44403 90412742
Anxiety 63.08 9.45 877 170425 308895 90148250
Constipation 62.95 9.45 808 170494 279587 90177558
Rhinorrhoea 62.59 9.45 331 170971 87985 90369160
Hip arthroplasty 62.45 9.45 33 171269 76175 90380970
Mucosal inflammation 62.26 9.45 16 171286 57609 90399536
Hepatotoxicity 62.06 9.45 7 171295 45835 90411310
Multi-organ disorder 61.61 9.45 43 171259 2157 90454988
Emphysema 61.43 9.45 94 171208 12061 90445084
Gastrooesophageal reflux disease 61.31 9.45 530 170772 165807 90291338
Respiratory symptom 60.76 9.45 56 171246 4196 90452949
C-reactive protein increased 60.25 9.45 161 171141 181228 90275917
Prescribed overdose 59.94 9.45 352 170950 97273 90359872
Bronchial disorder 59.77 9.45 37 171265 1513 90455632
Dyspnoea exertional 59.76 9.45 283 171019 72005 90385140
Endometrial ablation 59.56 9.45 32 171270 997 90456148
Intentional product use issue 58.93 9.45 211 171091 216681 90240464
Off label use 58.54 9.45 1612 169690 1100640 89356505
Back pain 58.27 9.45 882 170420 316293 90140852
Eye pruritus 57.78 9.45 152 171150 28875 90428270
Drug intolerance 57.72 9.45 554 170748 447037 90010108
Pulmonary fibrosis 57.59 9.45 71 171231 107432 90349713
Multiple allergies 57.52 9.45 103 171199 15043 90442102
Viral infection 56.80 9.45 190 171112 41224 90415921
Prescribed underdose 56.48 9.45 36 171266 74983 90382162
Autoimmune disorder 56.19 9.45 38 171264 76706 90380439
Salpingo-oophorectomy unilateral 55.74 9.45 30 171272 938 90456207
Joint range of motion decreased 55.08 9.45 108 171194 135535 90321610
Coma 54.48 9.45 35 171267 72597 90384548
Blood cholesterol increased 54.12 9.45 206 171096 207806 90249339
Sinusitis fungal 54.10 9.45 38 171264 1926 90455219
C-reactive protein abnormal 53.90 9.45 99 171203 127330 90329815
Adjustment disorder with depressed mood 53.70 9.45 20 171282 56733 90400412
Full blood count abnormal 52.97 9.45 171 171131 36426 90420719
Product complaint 52.80 9.45 93 171209 13407 90443738
Emotional distress 51.88 9.45 170 171132 36492 90420653
Weight decreased 51.84 9.45 1007 170295 378903 90078242
Sinus disorder 51.72 9.45 163 171139 34284 90422861
Erythema 51.60 9.45 661 170641 228585 90228560
Middle insomnia 51.36 9.45 104 171198 16647 90440498
Treatment failure 51.19 9.45 350 170952 303578 90153567
Prolonged expiration 51.01 9.45 31 171271 1226 90455919
Pre-existing condition improved 50.76 9.45 74 171228 9095 90448050
Stomatitis 49.98 9.45 309 170993 274389 90182756
Decreased appetite 49.83 9.45 463 170839 376077 90081068
Sputum discoloured 49.28 9.45 115 171187 20276 90436869
Dry skin 49.27 9.45 310 170992 87763 90369382
Stress 48.37 9.45 291 171011 81104 90376041
Lip dry 47.72 9.45 73 171229 100882 90356263
Grip strength decreased 47.66 9.45 63 171239 92513 90364632
Metabolic acidosis 47.28 9.45 23 171279 55653 90401492
Sciatica 47.26 9.45 74 171228 101308 90355837
Nasal oedema 46.83 9.45 60 171242 6524 90450621
Renal impairment 46.30 9.45 80 171222 105341 90351804
Foetal exposure during pregnancy 46.30 9.45 12 171290 42963 90414182
Decreased immune responsiveness 46.12 9.45 69 171233 8679 90448466
Oesophageal spasm 45.59 9.45 43 171259 3318 90453827
Diverticulum 45.52 9.45 82 171220 12031 90445114
Tinnitus 44.99 9.45 181 171121 42921 90414224
Exposure via skin contact 44.82 9.45 76 171226 10629 90446516
Embolism venous 44.73 9.45 44 171258 3576 90453569
Infusion site erythema 44.47 9.45 87 171215 13583 90443562
Hepatic function abnormal 44.32 9.45 16 171286 46272 90410873
Electrocardiogram QT prolonged 44.17 9.45 43 171259 72413 90384732
Hepatic cytolysis 43.72 9.45 4 171298 30912 90426233
Therapeutic product effect incomplete 43.59 9.45 559 170743 193337 90263808
Agranulocytosis 43.45 9.45 7 171295 34995 90422150
Lower respiratory tract infection 42.52 9.45 288 171014 250371 90206774
Depressed level of consciousness 42.31 9.45 45 171257 72739 90384406
Drug reaction with eosinophilia and systemic symptoms 42.29 9.45 14 171288 42744 90414401
Dermatitis allergic 42.18 9.45 98 171204 17229 90439916
Foot deformity 41.74 9.45 31 171271 59620 90397525
Injection site erythema 41.74 9.45 324 170978 98178 90358967
Oesophageal pain 41.22 9.45 46 171256 4328 90452817
Heart sounds 40.82 9.45 26 171276 1118 90456027
Concussion 40.31 9.45 74 171228 11017 90446128
Hypokalaemia 40.13 9.45 121 171181 130995 90326150
Infusion site swelling 39.85 9.45 76 171226 11644 90445501
Disease progression 39.51 9.45 157 171145 156458 90300687
Chest pain 39.51 9.45 835 170467 318810 90138335
Diastolic dysfunction 38.89 9.45 58 171244 7275 90449870
Lower limb fracture 38.73 9.45 63 171239 84950 90372195
Joint swelling 38.64 9.45 694 170608 502606 89954539
Pulmonary function test decreased 38.53 9.45 45 171257 4449 90452696
Inflammation 38.43 9.45 190 171112 178402 90278743
Gamma-glutamyltransferase increased 38.29 9.45 12 171290 37940 90419205
Therapeutic response unexpected 38.00 9.45 109 171193 21771 90435374
Dislocation of vertebra 38.00 9.45 30 171272 55938 90401207
Lupus-like syndrome 37.37 9.45 23 171279 48823 90408322
Surgery 37.29 9.45 176 171126 44711 90412434
Blood pressure inadequately controlled 37.05 9.45 52 171250 6172 90450973
Hepatic enzyme increased 36.36 9.45 472 170830 360264 90096881
Vision blurred 36.31 9.45 343 170959 109950 90347195
Exercise tolerance decreased 36.21 9.45 57 171245 7494 90449651
Depression 36.10 9.45 782 170520 299819 90157326
Bladder prolapse 35.99 9.45 31 171271 2124 90455021
Multiple organ dysfunction syndrome 35.69 9.45 46 171256 68290 90388855
Nasal discomfort 35.50 9.45 48 171254 5500 90451645
Palpitations 35.44 9.45 405 170897 136323 90320822
X-ray abnormal 35.30 9.45 21 171281 45403 90411742
Suicide attempt 35.17 9.45 55 171247 75344 90381801
Wrong technique in device usage process 35.11 9.45 49 171253 5786 90451359
Infusion site pain 34.94 9.45 99 171203 19639 90437506
Lactic acidosis 34.32 9.45 27 171275 50436 90406709
Hypotension 34.19 9.45 422 170880 324975 90132170
Eosinophil count increased 34.07 9.45 76 171226 13005 90444140
Bradycardia 33.82 9.45 67 171235 83780 90373365
Leukopenia 33.72 9.45 89 171213 100621 90356524
Hiatus hernia 33.58 9.45 115 171187 25246 90431899
Cardio-respiratory arrest 33.50 9.45 42 171260 63098 90394047
Hysterectomy 33.26 9.45 70 171232 11514 90445631
Knee arthroplasty 33.10 9.45 67 171235 83115 90374030
Cystic fibrosis 33.02 9.45 39 171263 3902 90453243
Pain 32.92 9.45 2244 169058 994097 89463048
Frequent bowel movements 32.84 9.45 202 171100 56733 90400412
Oxygen saturation decreased 32.81 9.45 329 170973 107154 90349991
Drug tolerance decreased 32.70 9.45 10 171292 32120 90425025
Cholecystitis chronic 32.53 9.45 63 171239 9763 90447382
Rhinitis allergic 32.50 9.45 87 171215 16698 90440447
Mite allergy 32.26 9.45 20 171282 820 90456325
Facet joint syndrome 32.15 9.45 88 171214 98301 90358844
Ear discomfort 32.08 9.45 64 171238 10136 90447009
Condition aggravated 31.72 9.45 870 170432 594675 89862470
Eosinophil count abnormal 31.70 9.45 20 171282 846 90456299
Candida infection 31.62 9.45 138 171164 33919 90423226
Fibromyalgia 31.59 9.45 244 171058 206025 90251120
Cytomegalovirus infection 31.53 9.45 6 171296 26596 90430549
Aphonia 31.45 9.45 71 171231 12248 90444897
Infusion site bruising 31.35 9.45 40 171262 4332 90452813
Respiration abnormal 31.33 9.45 55 171247 7908 90449237
Adrenal suppression 31.29 9.45 21 171281 988 90456157
Drug ineffective 31.17 9.45 2226 169076 1382072 89075073
Bone marrow failure 31.09 9.45 11 171291 32210 90424935
Septic shock 30.82 9.45 71 171231 84089 90373056
Lupus vulgaris 30.78 9.45 24 171278 45035 90412110
Therapy partial responder 30.78 9.45 3 171299 22040 90435105
Rales 30.61 9.45 82 171220 15745 90441400
Injection site bruising 30.44 9.45 186 171116 52121 90405024
Granuloma 30.09 9.45 47 171255 6138 90451007
Premature delivery 30.01 9.45 18 171284 38744 90418401
Retching 30.00 9.45 92 171210 19067 90438078
Toxic epidermal necrolysis 29.88 9.45 12 171290 32516 90424629
Eye haemorrhage 29.79 9.45 62 171240 10118 90447027
Hyperkalaemia 29.72 9.45 48 171254 64916 90392229
Pruritus 29.70 9.45 1279 170023 540246 89916899
Deep vein thrombosis 29.70 9.45 284 171018 91336 90365809
Inappropriate schedule of product administration 29.48 9.45 422 170880 149511 90307634
Onychomycosis 29.44 9.45 17 171285 37359 90419786
Dry eye 28.81 9.45 198 171104 57733 90399412
Serotonin syndrome 28.77 9.45 18 171284 37869 90419276
Ear infection 28.72 9.45 228 171074 69547 90387598
Poor quality device used 28.58 9.45 28 171274 2265 90454880
Acute respiratory failure 28.47 9.45 158 171144 42760 90414385
Infusion site pruritus 28.28 9.45 48 171254 6717 90450428
Fungal infection 28.26 9.45 157 171145 42504 90414641
Hyponatraemia 28.19 9.45 143 171159 133395 90323750
Hypercholesterolaemia 28.16 9.45 97 171205 100795 90356350
C-reactive protein 28.13 9.45 12 171290 31355 90425790
Cholestasis 27.90 9.45 17 171285 36282 90420863
Incorrect dose administered 27.77 9.45 249 171053 78681 90378464
Injection site swelling 27.70 9.45 201 171101 59638 90397507
Myalgia 27.62 9.45 475 170827 174650 90282495
Wound infection 27.26 9.45 106 171196 106296 90350849
Pulmonary embolism 27.25 9.45 372 170930 130448 90326697
Nasal discharge discolouration 26.88 9.45 30 171272 2823 90454322
Posterior reversible encephalopathy syndrome 26.56 9.45 5 171297 22334 90434811
Blood glucose increased 26.44 9.45 286 171016 94960 90362185
Acute sinusitis 25.96 9.45 36 171266 4225 90452920
Cardiac failure congestive 25.87 9.45 293 171009 98401 90358744
Finger deformity 25.86 9.45 15 171287 32882 90424263
Affective disorder 25.84 9.45 50 171252 7743 90449402
Adverse event 25.78 9.45 124 171178 117294 90339851
Depressed mood 25.78 9.45 173 171129 50049 90407096
Heart rate increased 25.57 9.45 326 170976 112576 90344569
Platelet count decreased 25.45 9.45 153 171149 136816 90320329
Decreased activity 25.28 9.45 51 171251 8141 90449004
Rectal haemorrhage 25.11 9.45 253 171049 82491 90374654
Neurotoxicity 25.11 9.45 5 171297 21462 90435683
Neutrophil count decreased 24.88 9.45 62 171240 71470 90385675
Red blood cell sedimentation rate increased 24.71 9.45 77 171225 82518 90374627
Urinary tract infection 24.35 9.45 753 170549 304879 90152266
Drug level increased 24.29 9.45 11 171291 27751 90429394
Seronegative arthritis 24.14 9.45 3 171299 18231 90438914
Infusion site reaction 24.05 9.45 85 171217 18954 90438191
Tricuspid valve incompetence 24.05 9.45 78 171224 16653 90440492
Ectropion 23.89 9.45 11 171291 244 90456901
Pregnancy 23.82 9.45 51 171251 61996 90395149
Product dose omission in error 23.76 9.45 89 171213 20414 90436731
Premature baby 23.45 9.45 9 171293 25068 90432077
Infusion site haemorrhage 23.43 9.45 39 171263 5372 90451773
Rectal prolapse 23.38 9.45 25 171277 2242 90454903
Analgesic therapy 23.30 9.45 15 171287 657 90456488
Neck pain 23.30 9.45 323 170979 113640 90343505
Gait inability 23.00 9.45 172 171130 146284 90310861
Anticoagulant therapy 22.95 9.45 16 171286 801 90456344
Swelling face 22.92 9.45 245 171057 81107 90376038
Death 22.74 9.45 673 170629 455878 90001267
Hepatic cirrhosis 22.65 9.45 54 171248 63199 90393946
Increased upper airway secretion 22.60 9.45 32 171270 3829 90453316
Sedation 22.60 9.45 35 171267 48136 90409009
Altered state of consciousness 22.57 9.45 16 171286 31516 90425629
Sinus operation 22.45 9.45 28 171274 2963 90454182
Ankle fracture 22.43 9.45 87 171215 20283 90436862
Interstitial lung disease 22.32 9.45 72 171230 76333 90380812
Tubulointerstitial nephritis 22.24 9.45 10 171292 25333 90431812
Malaise 22.23 9.45 1336 169966 584650 89872495
Paranasal sinus discomfort 22.02 9.45 41 171261 6169 90450976
Eosinophilic pneumonia chronic 21.75 9.45 10 171292 221 90456924
Antacid therapy 21.73 9.45 15 171287 739 90456406
Burning sensation 21.72 9.45 199 171103 63253 90393892
Neutropenic sepsis 21.68 9.45 4 171298 18126 90439019
Appendicolith 21.61 9.45 15 171287 746 90456399
Drug eruption 21.59 9.45 21 171281 35386 90421759
Myocardial infarction 21.52 9.45 300 171002 105672 90351473
Rhabdomyolysis 21.51 9.45 40 171262 51216 90405929
Lymphoedema 21.50 9.45 66 171236 13687 90443458
Migraine 21.47 9.45 491 170811 189901 90267244
Vitamin D decreased 21.12 9.45 60 171242 11919 90445226
Rheumatoid nodule 21.03 9.45 6 171296 20160 90436985
Retinitis 21.02 9.45 25 171277 38433 90418712
Psoriasis 20.91 9.45 394 170908 147360 90309785
Drug therapy 20.78 9.45 15 171287 794 90456351
Biliary dyskinesia 20.59 9.45 25 171277 2574 90454571
Oesophagogastroduodenoscopy 20.58 9.45 9 171293 176 90456969
Musculoskeletal chest pain 20.37 9.45 94 171208 23656 90433489
Cytokine release syndrome 20.27 9.45 14 171288 27959 90429186
Injection site pruritus 20.06 9.45 172 171130 53662 90403483
Iron deficiency anaemia 19.81 9.45 93 171209 23569 90433576
Throat clearing 19.79 9.45 30 171272 3817 90453328
Tooth infection 19.70 9.45 83 171219 20087 90437058
Upper limb fracture 19.70 9.45 87 171215 21491 90435654
Thermal burn 19.57 9.45 41 171261 6721 90450424
Intentional self-injury 19.57 9.45 16 171286 29318 90427827
Infusion site nodule 19.56 9.45 20 171282 1703 90455442
Bacterial infection 19.53 9.45 92 171210 23352 90433793
Status asthmaticus 19.37 9.45 15 171287 884 90456261
Cushing's syndrome 19.15 9.45 13 171289 623 90456522
Hepatocellular injury 19.06 9.45 16 171286 28942 90428203
Rash maculo-papular 18.95 9.45 30 171272 40903 90416242
Throat irritation 18.89 9.45 157 171145 48538 90408607
Depressive symptom 18.88 9.45 35 171267 5250 90451895
Adverse reaction 18.85 9.45 17 171285 29695 90427450
Tooth abscess 18.81 9.45 71 171231 16342 90440803
Injection site inflammation 18.70 9.45 32 171270 4509 90452636
Arthropod bite 18.57 9.45 47 171255 8720 90448425
Product label confusion 18.56 9.45 10 171292 22840 90434305
Infusion site extravasation 18.47 9.45 52 171250 10276 90446869
Hypersensitivity 18.44 9.45 1043 170259 453634 90003511
Walking aid user 18.44 9.45 24 171278 35482 90421663
Colitis ulcerative 18.16 9.45 184 171118 60082 90397063
Alanine aminotransferase increased 18.10 9.45 140 171162 118198 90338947
Facial discomfort 18.09 9.45 10 171292 330 90456815
Injection site rash 18.09 9.45 92 171210 24081 90433064
Bronchial obstruction 18.08 9.45 19 171283 1670 90455475
Intentional dose omission 18.02 9.45 74 171228 17709 90439436
Eye irritation 18.01 9.45 118 171184 33860 90423285
Thyroid disorder 18.01 9.45 74 171228 17711 90439434
Breath sounds abnormal 18.00 9.45 67 171235 15319 90441826
Anhedonia 18.00 9.45 55 171247 11376 90445769
Throat tightness 17.89 9.45 106 171196 29378 90427767
Skin swelling 17.87 9.45 39 171263 6575 90450570
Hereditary angioedema 17.59 9.45 48 171254 9317 90447828
Sinus congestion 17.55 9.45 100 171202 27324 90429821
Drug resistance 17.50 9.45 19 171283 30430 90426715
Cystic fibrosis related diabetes 17.45 9.45 6 171296 59 90457086
Lemierre syndrome 17.41 9.45 7 171295 110 90457035
Liver disorder 17.38 9.45 146 171156 121123 90336022
Type V hyperlipidaemia 17.38 9.45 14 171288 874 90456271
Circulatory collapse 17.35 9.45 13 171289 24891 90432254
Appetite disorder 17.34 9.45 47 171255 9086 90448059
Creatinine renal clearance decreased 17.32 9.45 7 171295 18892 90438253
Sinus headache 17.29 9.45 38 171264 6438 90450707
Infusion site mass 17.25 9.45 21 171281 2168 90454977
Lymphopenia 17.19 9.45 11 171291 22870 90434275
Abortion spontaneous 17.17 9.45 49 171253 54007 90403138
Pulmonary mass 17.17 9.45 103 171199 28669 90428476
Colitis 17.15 9.45 205 171097 69737 90387408
Bronchial irritation 17.14 9.45 5 171297 27 90457118
Limb injury 17.06 9.45 110 171192 31398 90425747
Haematochezia 17.02 9.45 207 171095 70706 90386439
Blood creatinine increased 16.92 9.45 117 171185 101269 90355876
Renal failure 16.91 9.45 162 171140 130845 90326300
Eustachian tube dysfunction 16.89 9.45 13 171289 759 90456386
Poisoning 16.87 9.45 4 171298 15213 90441932
Joint dislocation 16.82 9.45 37 171265 44545 90412600
Joint stiffness 16.79 9.45 83 171219 77959 90379186
Injection site urticaria 16.73 9.45 73 171229 17938 90439207
Peak expiratory flow rate decreased 16.71 9.45 12 171290 630 90456515
Eosinophilic bronchitis 16.69 9.45 12 171290 631 90456514
Palmar-plantar erythrodysaesthesia syndrome 16.65 9.45 17 171285 28006 90429139
Allergy to animal 16.64 9.45 18 171284 1636 90455509
Product delivery mechanism issue 16.63 9.45 11 171291 505 90456640
Acute generalised exanthematous pustulosis 16.44 9.45 3 171299 13700 90443445
Ageusia 16.37 9.45 67 171235 16009 90441136
Hyposmia 16.31 9.45 14 171288 955 90456190
Stevens-Johnson syndrome 16.15 9.45 19 171283 29357 90427788
Body temperature increased 16.14 9.45 38 171264 44672 90412473
Cataplexy 16.10 9.45 17 171285 1503 90455642
Injection site haemorrhage 16.03 9.45 100 171202 28218 90428927
Snoring 15.92 9.45 32 171270 5094 90452051
Peripheral swelling 15.89 9.45 629 170673 412477 90044668
Influenza like illness 15.88 9.45 227 171075 80384 90376761
Ligament sprain 15.79 9.45 62 171240 14537 90442608
Restless legs syndrome 15.76 9.45 84 171218 22386 90434759
Essential hypertension 15.68 9.45 36 171266 6279 90450866
Respiratory tract congestion 15.65 9.45 97 171205 27313 90429832
Bronchospasm 15.62 9.45 79 171223 20630 90436515
Cardiac failure 15.62 9.45 132 171170 109364 90347781
Hypothermia 15.58 9.45 5 171297 15570 90441575
Neck injury 15.50 9.45 21 171281 2411 90454734
Vitamin D deficiency 15.44 9.45 70 171232 17486 90439659
Acute myeloid leukaemia 15.40 9.45 10 171292 20630 90436515
Product taste abnormal 15.31 9.45 21 171281 2439 90454706
Hypocalcaemia 15.31 9.45 36 171266 42332 90414813
Acute respiratory distress syndrome 15.30 9.45 19 171283 28667 90428478
Lip swelling 15.26 9.45 125 171177 38485 90418660
Vomiting 15.22 9.45 1283 170019 787010 89670135
Blood pressure increased 15.19 9.45 484 170818 196733 90260412
Cytopenia 15.13 9.45 7 171295 17442 90439703
Middle ear effusion 15.12 9.45 22 171280 2699 90454446
Facial pain 15.09 9.45 57 171245 13125 90444020
Gangrene 15.06 9.45 3 171299 12873 90444272
Fracture displacement 15.03 9.45 15 171287 1241 90455904
Total lung capacity abnormal 14.99 9.45 6 171296 93 90457052
Hepatic failure 14.96 9.45 33 171269 39695 90417450
Torsade de pointes 14.96 9.45 5 171297 15177 90441968
Dermatitis contact 14.92 9.45 58 171244 13537 90443608
Jaundice 14.90 9.45 24 171278 32493 90424652
Exostosis 14.88 9.45 51 171251 53083 90404062
Transplant rejection 14.86 9.45 3 171299 12755 90444390
Dizziness 14.86 9.45 1300 170002 587984 89869161
Malnutrition 14.86 9.45 72 171230 18486 90438659
FEV1/FVC ratio decreased 14.85 9.45 7 171295 164 90456981
Insurance issue 14.78 9.45 50 171252 10908 90446237
Mydriasis 14.70 9.45 5 171297 15007 90442138
Bursitis 14.68 9.45 339 170963 131315 90325830
Metastases to bone 14.56 9.45 16 171286 25489 90431656
Gallbladder injury 14.54 9.45 15 171287 1291 90455854
Asthmatic crisis 14.53 9.45 18 171284 1892 90455253
Metastases to lung 14.53 9.45 6 171296 15985 90441160
Pharyngitis streptococcal 14.51 9.45 55 171247 12687 90444458
Cholecystectomy 14.44 9.45 52 171250 11703 90445442
Metastases to liver 14.42 9.45 20 171282 28787 90428358
Shock 14.39 9.45 20 171282 28758 90428387
Exposure during pregnancy 14.38 9.45 569 170733 237841 90219304
Breast cancer stage III 14.32 9.45 97 171205 84350 90372795
General symptom 14.16 9.45 5 171297 14663 90442482
Maternal exposure timing unspecified 14.10 9.45 13 171289 22470 90434675
Peritonitis 14.10 9.45 10 171292 19695 90437450
Gastroenteritis viral 14.07 9.45 102 171200 30253 90426892
Oral herpes 14.04 9.45 110 171192 33414 90423731
Blood lactate dehydrogenase increased 14.02 9.45 17 171285 25915 90431230
Infusion site discharge 13.99 9.45 20 171282 2415 90454730
Road traffic accident 13.92 9.45 133 171169 107493 90349652
Live birth 13.85 9.45 90 171212 79017 90378128
Somnambulism 13.84 9.45 34 171268 6194 90450951
Inappropriate antidiuretic hormone secretion 13.82 9.45 10 171292 19495 90437650
Bronchial hyperreactivity 13.81 9.45 18 171284 1990 90455155
Metastases to central nervous system 13.78 9.45 8 171294 17534 90439611
Tracheal mass 13.75 9.45 3 171299 3 90457142
Eustachian tube disorder 13.74 9.45 6 171296 117 90457028
Secretion discharge 13.70 9.45 63 171239 15833 90441312
Pharyngeal abscess 13.65 9.45 9 171293 411 90456734
Neoplasm progression 13.64 9.45 41 171261 44445 90412700
Essential tremor 13.57 9.45 15 171287 1397 90455748
Hypoglycaemia 13.52 9.45 77 171225 69771 90387374
Overdose 13.47 9.45 392 170910 157317 90299828
Ulcer haemorrhage 13.45 9.45 18 171284 26303 90430842
Gait disturbance 13.45 9.45 382 170920 260114 90197031
Peritoneal perforation 13.33 9.45 6 171296 126 90457019
Bronchospasm paradoxical 13.33 9.45 6 171296 126 90457019
Herpes dermatitis 13.29 9.45 6 171296 127 90457018
Multiple drug therapy 13.24 9.45 36 171266 6973 90450172
Musculoskeletal pain 13.15 9.45 236 171066 171015 90286130
Immunoglobulins increased 13.11 9.45 10 171292 576 90456569
Respiratory arrest 13.11 9.45 27 171275 33284 90423861
Sneezing 13.07 9.45 99 171203 29770 90427375
Hyperlipidaemia 13.02 9.45 81 171221 22835 90434310
Bronchial wall thickening 12.98 9.45 18 171284 2113 90455032
Skin necrosis 12.93 9.45 8 171294 16933 90440212
Body mass index increased 12.85 9.45 15 171287 1482 90455663
Hirsutism 12.82 9.45 16 171286 1694 90455451
Nephropathy toxic 12.82 9.45 4 171298 12684 90444461
Breast cancer stage II 12.78 9.45 30 171272 35304 90421841
Night sweats 12.76 9.45 169 171133 128597 90328548
Osteonecrosis of jaw 12.75 9.45 35 171267 39068 90418077
Hypertransaminasaemia 12.75 9.45 7 171295 15818 90441327
Purpura 12.71 9.45 6 171296 14772 90442373
Toxic skin eruption 12.67 9.45 7 171295 15767 90441378
Vocal cord atrophy 12.53 9.45 3 171299 6 90457139
Cardiospasm 12.53 9.45 23 171279 3423 90453722
Gout 12.50 9.45 64 171238 16795 90440350
Blue toe syndrome 12.46 9.45 9 171293 477 90456668
Panic attack 12.45 9.45 89 171213 26276 90430869
Personality disorder 12.44 9.45 4 171298 12440 90444705
Intervertebral disc protrusion 12.38 9.45 91 171211 27105 90430040
Suspected product contamination 12.35 9.45 5 171297 80 90457065
Reflux laryngitis 12.32 9.45 7 171295 244 90456901
Gluten sensitivity 12.25 9.45 11 171291 797 90456348
Palmoplantar keratoderma 12.24 9.45 23 171279 3484 90453661
Anaphylactic reaction 12.24 9.45 233 171069 87291 90369854
Foreign body in reproductive tract 12.17 9.45 13 171289 1164 90455981
Gammopathy 12.16 9.45 6 171296 156 90456989
Respiratory tract irritation 12.15 9.45 9 171293 496 90456649
Sunburn 12.13 9.45 22 171280 3245 90453900
Extrapyramidal disorder 12.03 9.45 8 171294 16295 90440850
Infusion site scab 12.02 9.45 5 171297 86 90457059
Wrong technique in product usage process 11.96 9.45 196 171106 71375 90385770
Distal intestinal obstruction syndrome 11.87 9.45 9 171293 514 90456631
Nodular vasculitis 11.86 9.45 5 171297 89 90457056
Hypervolaemia 11.86 9.45 104 171198 32653 90424492
Blood immunoglobulin E increased 11.85 9.45 26 171276 4399 90452746
Porphyria acute 11.75 9.45 10 171292 17965 90439180
Noninfective encephalitis 11.73 9.45 9 171293 523 90456622
Tension headache 11.70 9.45 36 171266 7473 90449672
Sleep terror 11.70 9.45 26 171276 4438 90452707
Inhalation therapy 11.67 9.45 4 171298 39 90457106
Hypercalcaemia 11.66 9.45 30 171272 34210 90422935
Parkinsonism 11.66 9.45 6 171296 14059 90443086
Device breakage 11.61 9.45 55 171247 13989 90443156
Scratch 11.57 9.45 43 171259 9823 90447322
Atrial tachycardia 11.55 9.45 31 171271 5959 90451186
Hypoalbuminaemia 11.46 9.45 8 171294 15889 90441256
Limb operation 11.45 9.45 26 171276 4501 90452644
Product preparation error 11.44 9.45 44 171258 10217 90446928
Diverticulitis 11.32 9.45 133 171169 45054 90412091
Pneumonitis 11.31 9.45 44 171258 44126 90413019
Gallbladder disorder 11.25 9.45 70 171232 19733 90437412
Polyneuropathy 11.19 9.45 12 171290 19329 90437816
Heart rate decreased 11.07 9.45 152 171150 53353 90403792
Respiratory depression 11.02 9.45 8 171294 15567 90441578
Expiratory reserve volume decreased 11.00 9.45 4 171298 47 90457098
Perioral dermatitis 10.90 9.45 9 171293 582 90456563
Chronic respiratory failure 10.87 9.45 19 171283 2722 90454423
Nasal dryness 10.87 9.45 29 171273 5554 90451591
Conjunctivitis allergic 10.86 9.45 13 171289 1319 90455826
Economic problem 10.82 9.45 21 171281 3260 90453885
Panniculitis 10.80 9.45 7 171295 14451 90442694
Medication error 10.78 9.45 105 171197 84547 90372598
Femoral neck fracture 10.75 9.45 3 171299 10230 90446915
Therapeutic response shortened 10.67 9.45 77 171225 22802 90434343
Fracture pain 10.67 9.45 12 171290 1139 90456006
Premature labour 10.65 9.45 6 171296 13370 90443775
Aspartate aminotransferase increased 10.60 9.45 134 171168 102803 90354342
Diabetes mellitus inadequate control 10.59 9.45 66 171236 18618 90438527
Hemiplegia 10.55 9.45 9 171293 16151 90440994
Ischaemic stroke 10.50 9.45 16 171286 22150 90434995
Shock haemorrhagic 10.48 9.45 5 171297 12240 90444905
Wolff-Parkinson-White syndrome 10.48 9.45 6 171296 212 90456933
Obstruction 10.46 9.45 23 171279 3898 90453247
Akathisia 10.44 9.45 4 171298 11155 90445990
Cellulitis 10.43 9.45 236 171066 91101 90366044
Excessive cerumen production 10.39 9.45 9 171293 621 90456524
Idiopathic angioedema 10.37 9.45 4 171298 56 90457089
Neuroleptic malignant syndrome 10.36 9.45 8 171294 15088 90442057
Transient ischaemic attack 10.34 9.45 126 171176 43050 90414095
Hypertensive crisis 10.33 9.45 11 171291 17773 90439372
Hypermetropia 10.32 9.45 8 171294 472 90456673
Accidental exposure to product 10.31 9.45 124 171178 42242 90414903
Respiratory disorder 10.28 9.45 176 171126 64640 90392505
Diabetic ketoacidosis 10.28 9.45 19 171283 24388 90432757
Pruritus genital 10.25 9.45 25 171277 4533 90452612
Incorrect route of product administration 10.24 9.45 55 171247 50571 90406574
Intercepted product storage error 10.16 9.45 8 171294 483 90456662
Terminal insomnia 10.14 9.45 12 171290 1203 90455942
Respiratory syncytial virus infection 10.14 9.45 43 171259 10437 90446708
Arthralgia 10.13 9.45 1303 169999 777219 89679926
Dust allergy 10.10 9.45 10 171292 819 90456326
Hereditary non-polyposis colorectal cancer syndrome 10.10 9.45 5 171297 131 90457014
Factitious disorder 9.96 9.45 5 171297 135 90457010
Proteinuria 9.93 9.45 18 171284 23273 90433872
Chills 9.92 9.45 323 170979 131658 90325487
Peripheral venous disease 9.90 9.45 106 171196 83815 90373330
Pneumococcal infection 9.90 9.45 12 171290 1233 90455912
Cardiovascular deconditioning 9.88 9.45 3 171299 19 90457126
Suspected COVID-19 9.86 9.45 18 171284 2668 90454477
Parasomnia 9.85 9.45 9 171293 667 90456478
Brain oedema 9.82 9.45 11 171291 17374 90439771
Product container issue 9.82 9.45 16 171286 2165 90454980
Vertigo 9.82 9.45 186 171116 69625 90387520
Perinatal depression 9.80 9.45 10 171292 849 90456296
Non-pitting oedema 9.79 9.45 5 171297 140 90457005
Nasal septum deviation 9.78 9.45 15 171287 1928 90455217
Uterine perforation 9.78 9.45 34 171268 7520 90449625
Disseminated intravascular coagulation 9.77 9.45 16 171286 21522 90435623
Chronic gastrointestinal bleeding 9.76 9.45 5 171297 141 90457004
Flat affect 9.75 9.45 14 171288 1697 90455448
CFTR gene mutation 9.74 9.45 6 171296 243 90456902
Haemodynamic instability 9.74 9.45 5 171297 11734 90445411
Croup infectious 9.72 9.45 9 171293 678 90456467
Pneumonia aspiration 9.72 9.45 42 171260 40898 90416247
Cystitis interstitial 9.67 9.45 14 171288 1710 90455435
Stress fracture 9.66 9.45 37 171265 8574 90448571
Immunisation 9.65 9.45 16 171286 2197 90454948
Oliguria 9.63 9.45 4 171298 10620 90446525
Infusion site rash 9.57 9.45 17 171285 2466 90454679
Acne 9.55 9.45 89 171213 28418 90428727
Contusion 9.54 9.45 383 170919 250833 90206312
Low birth weight baby 9.54 9.45 3 171299 9464 90447681
Gastrointestinal toxicity 9.54 9.45 3 171299 9464 90447681
Pericardial effusion 9.49 9.45 109 171193 36724 90420421
Fracture 9.46 9.45 17 171285 22059 90435086

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 766.84 11.17 700 67465 61614 42491556
Wheezing 265.80 11.17 380 67785 54401 42498769
Cough 246.16 11.17 733 67432 177370 42375800
Toxicity to various agents 245.42 11.17 37 68128 229099 42324071
Sinusitis 193.52 11.17 303 67862 46989 42506181
Dyspnoea 191.51 11.17 1285 66880 441336 42111834
Productive cough 162.51 11.17 294 67871 51273 42501897
Nasal congestion 156.95 11.17 214 67951 29287 42523883
Product dose omission issue 146.26 11.17 560 67605 153805 42399365
Acute kidney injury 141.80 11.17 231 67934 367106 42186064
Nasal polyps 139.08 11.17 83 68082 3768 42549402
Infective pulmonary exacerbation of cystic fibrosis 133.14 11.17 106 68059 7712 42545458
Dermatitis atopic 114.10 11.17 119 68046 12285 42540885
Febrile neutropenia 111.10 11.17 81 68084 185622 42367548
Full blood count abnormal 110.66 11.17 183 67982 29693 42523477
Eosinophilic granulomatosis with polyangiitis 109.84 11.17 99 68066 8539 42544631
Off label use 99.59 11.17 607 67558 637728 41915442
Sleep disorder due to a general medical condition 96.45 11.17 129 68036 17324 42535846
Rhinorrhoea 88.56 11.17 172 67993 31622 42521548
Bronchitis 87.77 11.17 217 67948 46984 42506186
Thrombocytopenia 80.64 11.17 112 68053 190167 42363003
Illness 79.59 11.17 143 68022 24787 42528383
Drug abuse 79.46 11.17 34 68131 104737 42448433
Injection site pain 77.79 11.17 236 67929 57562 42495608
Nasopharyngitis 76.38 11.17 301 67864 83695 42469475
Adrenal suppression 75.80 11.17 35 68130 930 42552240
Completed suicide 75.27 11.17 30 68135 96435 42456735
Chronic obstructive pulmonary disease 73.34 11.17 245 67920 62869 42490301
Neutropenia 71.64 11.17 131 68034 199300 42353870
Obstructive airways disorder 70.24 11.17 135 68030 24624 42528546
Upper-airway cough syndrome 69.68 11.17 57 68108 4309 42548861
Injection site swelling 68.33 11.17 108 68057 16865 42536305
Pneumonia 67.17 11.17 996 67169 421153 42132017
Sinus disorder 64.84 11.17 72 68093 7978 42545192
Upper respiratory tract infection 64.23 11.17 180 67985 41993 42511177
Product complaint 59.79 11.17 60 68105 5917 42547253
Malignant neoplasm progression 58.86 11.17 52 68113 108348 42444822
Cystic fibrosis 58.31 11.17 38 68127 2017 42551153
Sputum discoloured 57.69 11.17 76 68089 10056 42543114
Dry skin 54.69 11.17 186 67979 48152 42505018
Eosinophil count increased 54.10 11.17 76 68089 10687 42542483
Ear infection 53.67 11.17 83 68082 12721 42540449
Impaired quality of life 52.69 11.17 87 68078 14090 42539080
Influenza 51.88 11.17 217 67948 61958 42491212
Foetal malformation 51.46 11.17 17 68148 176 42552994
Injection site pruritus 51.17 11.17 69 68096 9336 42543834
Overdose 50.80 11.17 56 68109 105208 42447962
Product quality issue 50.10 11.17 97 68068 17785 42535385
Myelosuppression 49.60 11.17 4 68161 40457 42512713
Renal impairment 49.60 11.17 62 68103 110166 42443004
Therapeutic product effect incomplete 48.96 11.17 234 67931 70705 42482465
Chest discomfort 48.45 11.17 216 67949 63400 42489770
Gastrooesophageal reflux disease 47.26 11.17 169 67996 44854 42508316
Interstitial lung disease 45.86 11.17 35 68130 78427 42474743
Anaemia 43.68 11.17 266 67899 280012 42273158
Intentional overdose 43.53 11.17 14 68151 51442 42501728
Pancytopenia 43.44 11.17 76 68089 117667 42435503
Sleep apnoea syndrome 42.99 11.17 102 68063 21506 42531664
Disease progression 42.65 11.17 105 68060 143551 42409619
Dyspnoea exertional 42.59 11.17 176 67989 49972 42503198
Hyperkalaemia 42.00 11.17 40 68125 80418 42472752
Drug interaction 41.81 11.17 253 67912 266746 42286424
Sleep disorder 41.01 11.17 169 67996 47926 42505244
Breath sounds abnormal 40.69 11.17 71 68094 12022 42541148
Painful respiration 40.53 11.17 26 68139 1343 42551827
Renal failure 40.39 11.17 108 68057 143618 42409552
Increased upper airway secretion 40.01 11.17 33 68132 2523 42550647
Wrong technique in device usage process 39.87 11.17 34 68131 2723 42550447
Respiratory tract congestion 39.76 11.17 55 68110 7623 42545547
Eye disorder 38.85 11.17 68 68097 11544 42541626
Hepatic function abnormal 38.66 11.17 17 68148 51550 42501620
Throat clearing 38.19 11.17 19 68146 598 42552572
Dysphonia 38.10 11.17 116 68049 28334 42524836
Coma 38.07 11.17 19 68146 53535 42499635
Injection site erythema 37.68 11.17 93 68072 20102 42533068
Product administration interrupted 37.58 11.17 43 68122 4923 42548247
Chronic sinusitis 37.56 11.17 36 68129 3356 42549814
Blood immunoglobulin E increased 37.38 11.17 37 68128 3588 42549582
Rhabdomyolysis 37.10 11.17 42 68123 77977 42475193
Bronchial hyperreactivity 36.85 11.17 28 68137 1901 42551269
C-reactive protein increased 36.32 11.17 29 68136 63531 42489639
Seasonal allergy 36.28 11.17 54 68111 8001 42545169
Bronchospasm 36.23 11.17 70 68095 12815 42540355
Sinus congestion 36.14 11.17 50 68115 6930 42546240
Anosmia 36.13 11.17 43 68122 5133 42548037
Mucosal inflammation 35.88 11.17 17 68148 49357 42503813
Drug resistance 35.52 11.17 6 68159 34242 42518928
Eosinophil count 35.42 11.17 13 68152 188 42552982
Metabolic acidosis 34.52 11.17 20 68145 51838 42501332
Chest injury 33.82 11.17 26 68139 1796 42551374
Leukopenia 33.66 11.17 42 68123 74704 42478466
Septic shock 33.06 11.17 60 68105 91612 42461558
Depressed level of consciousness 32.65 11.17 18 68147 47952 42505218
Cushingoid 31.77 11.17 33 68132 3389 42549781
Nasal inflammation 31.50 11.17 15 68150 428 42552742
Loss of personal independence in daily activities 31.28 11.17 160 68005 49656 42503514
Delirium 31.23 11.17 23 68142 52496 42500674
Chorioretinopathy 30.97 11.17 23 68142 1508 42551662
Vocal cord dysfunction 30.81 11.17 12 68153 206 42552964
Cytomegalovirus infection 30.69 11.17 7 68158 32299 42520871
Treatment failure 30.55 11.17 33 68132 62591 42490579
Cushing's syndrome 30.18 11.17 14 68151 376 42552794
Eosinophilic oesophagitis 30.10 11.17 17 68148 695 42552475
Drug-induced liver injury 29.68 11.17 12 68153 38261 42514909
Bradycardia 29.03 11.17 58 68107 85426 42467744
Skin fissures 28.97 11.17 54 68111 9622 42543548
Paranasal sinus discomfort 28.84 11.17 20 68145 1177 42551993
Rash maculo-papular 28.69 11.17 12 68153 37491 42515679
Injection site urticaria 28.53 11.17 31 68134 3352 42549818
Cholestasis 27.71 11.17 9 68156 32870 42520300
Dyspnoea paroxysmal nocturnal 27.65 11.17 22 68143 1598 42551572
Hypotension 27.22 11.17 272 67893 257359 42295811
Multiple organ dysfunction syndrome 27.18 11.17 73 68092 96962 42456208
Cytokine release syndrome 27.13 11.17 19 68146 44508 42508662
Trisomy 18 27.03 11.17 17 68148 848 42552322
Agranulocytosis 26.48 11.17 8 68157 30604 42522566
No adverse event 26.39 11.17 128 68037 38893 42514277
Middle insomnia 26.37 11.17 46 68119 7787 42545383
Bone marrow failure 26.28 11.17 10 68155 33083 42520087
Snoring 26.09 11.17 32 68133 3941 42549229
Fatigue 25.40 11.17 892 67273 434749 42118421
Rhinitis allergic 25.32 11.17 31 68134 3811 42549359
Cardiac failure 25.21 11.17 87 68078 106769 42446401
Sneezing 24.94 11.17 40 68125 6323 42546847
General physical health deterioration 24.86 11.17 141 68024 151105 42402065
Nasal obstruction 24.77 11.17 17 68148 984 42552186
Altered state of consciousness 24.68 11.17 8 68157 29251 42523919
Anxiety 24.64 11.17 294 67871 118266 42434904
Peripheral swelling 24.41 11.17 236 67929 90034 42463136
Hypertrophic osteoarthropathy 24.29 11.17 8 68157 82 42553088
Vision blurred 24.24 11.17 158 68007 53541 42499629
Foetal exposure during pregnancy 24.13 11.17 24 68141 47287 42505883
Blood creatine phosphokinase increased 24.11 11.17 25 68140 48313 42504857
Lacrimation increased 23.92 11.17 56 68109 11702 42541468
Hypoacusis 23.87 11.17 75 68090 18627 42534543
Forced expiratory volume decreased 23.37 11.17 43 68122 7587 42545583
Drug reaction with eosinophilia and systemic symptoms 23.04 11.17 20 68145 42055 42511115
Respiratory syncytial virus infection 22.79 11.17 41 68124 7111 42546059
Suffocation feeling 22.67 11.17 14 68151 676 42552494
Blood creatinine increased 22.44 11.17 95 68070 109908 42443262
Pulmonary function test decreased 22.42 11.17 36 68129 5696 42547474
Increased viscosity of bronchial secretion 22.37 11.17 10 68155 246 42552924
Eosinophilic bronchitis 22.37 11.17 10 68155 246 42552924
Pruritus 22.36 11.17 425 67740 188346 42364824
Carcinoid tumour of the gastrointestinal tract 22.26 11.17 7 68158 61 42553109
Cerebral infarction 22.24 11.17 11 68154 31158 42522012
Forced expiratory flow decreased 22.17 11.17 9 68156 173 42552997
Arthralgia 21.94 11.17 455 67710 204783 42348387
Nasal discomfort 21.84 11.17 19 68146 1563 42551607
Platelet count decreased 21.81 11.17 131 68034 138450 42414720
Sinus headache 21.72 11.17 17 68148 1206 42551964
Oropharyngeal pain 21.64 11.17 129 68036 42381 42510789
Viral infection 21.57 11.17 82 68083 22401 42530769
Hypoaesthesia 21.42 11.17 191 67974 71272 42481898
Lung hernia 21.41 11.17 7 68158 70 42553100
Toxic epidermal necrolysis 21.38 11.17 8 68157 26742 42526428
Eye swelling 21.30 11.17 54 68111 11866 42541304
Death 21.17 11.17 583 67582 470602 42082568
Secondary adrenocortical insufficiency 20.86 11.17 21 68144 2078 42551092
Confusional state 20.70 11.17 170 67995 167427 42385743
Headache 20.70 11.17 515 67650 238854 42314316
Kidney infection 20.54 11.17 38 68127 6732 42546438
Haemoptysis 20.33 11.17 135 68030 46032 42507138
Walking aid user 20.26 11.17 23 68142 2610 42550560
Foreign body in throat 20.12 11.17 12 68153 544 42552626
Premature baby 20.12 11.17 6 68159 23147 42530023
Status asthmaticus 20.06 11.17 10 68155 316 42552854
Eye irritation 19.94 11.17 51 68114 11267 42541903
Cortisol decreased 19.94 11.17 17 68148 1361 42551809
Hospitalisation 19.93 11.17 194 67971 74136 42479034
Nervous system neoplasm 19.89 11.17 8 68157 150 42553020
Neutrophil count decreased 19.88 11.17 45 68120 63370 42489800
Hepatic failure 19.81 11.17 19 68146 38081 42515089
Nasal disorder 19.79 11.17 20 68145 1989 42551181
Epidural lipomatosis 19.74 11.17 19 68146 1781 42551389
Dry eye 19.62 11.17 62 68103 15444 42537726
Cardiac arrest 19.58 11.17 99 68066 109221 42443949
Back pain 19.55 11.17 327 67838 141449 42411721
Plethoric face 19.53 11.17 4 68161 3 42553167
Product dose omission in error 19.47 11.17 42 68123 8312 42544858
Contraindicated product administered 19.47 11.17 8 68157 25264 42527906
Ocular hyperaemia 19.45 11.17 63 68102 15900 42537270
Hepatotoxicity 19.33 11.17 8 68157 25159 42528011
Muscle spasms 19.04 11.17 216 67949 85828 42467342
Urticaria 18.77 11.17 191 67974 73845 42479325
Eye pruritus 18.65 11.17 50 68115 11362 42541808
Tubulointerstitial nephritis 18.52 11.17 14 68151 31534 42521636
Sputum increased 18.43 11.17 24 68141 3139 42550031
Injection site bruising 18.34 11.17 50 68115 11475 42541695
Pre-existing condition improved 18.08 11.17 23 68142 2940 42550230
Croup infectious 17.95 11.17 11 68154 524 42552646
Therapeutic response shortened 17.89 11.17 55 68110 13499 42539671
Therapy partial responder 17.74 11.17 5 68160 20016 42533154
Gastroenteritis viral 17.73 11.17 40 68125 8159 42545011
Insurance issue 17.69 11.17 27 68138 4089 42549081
Infusion site swelling 17.68 11.17 24 68141 3268 42549902
Stridor 17.45 11.17 22 68143 2786 42550384
Blood lactate dehydrogenase increased 17.44 11.17 10 68155 26071 42527099
Sensation of foreign body 17.40 11.17 25 68140 3588 42549582
Skin exfoliation 17.39 11.17 120 68045 41433 42511737
Infusion site erythema 17.35 11.17 25 68140 3597 42549573
Nephropathy toxic 17.35 11.17 3 68162 16835 42536335
Infusion site pain 17.28 11.17 31 68134 5364 42547806
Dysarthria 17.26 11.17 23 68142 39784 42513386
Melaena 17.20 11.17 22 68143 38724 42514446
Ischaemic stroke 17.19 11.17 7 68158 22226 42530944
Nasal discharge discolouration 17.18 11.17 10 68155 433 42552737
Serotonin syndrome 17.15 11.17 10 68155 25835 42527335
Gamma-glutamyltransferase increased 17.13 11.17 16 68149 32481 42520689
Sepsis 16.90 11.17 221 67944 199113 42354057
Oral candidiasis 16.79 11.17 56 68109 14349 42538821
Extrapyramidal disorder 16.75 11.17 3 68162 16409 42536761
Rash macular 16.53 11.17 62 68103 16829 42536341
Drug ineffective 16.36 11.17 833 67332 629364 41923806
Hypomagnesaemia 16.27 11.17 13 68152 28475 42524695
Capnocytophaga sepsis 16.23 11.17 4 68161 12 42553158
Weight decreased 16.10 11.17 441 67724 207507 42345663
Hyposmia 16.09 11.17 9 68156 361 42552809
Facial discomfort 16.09 11.17 6 68159 91 42553079
Lactic acidosis 15.98 11.17 30 68135 45231 42507939
Pharyngitis streptococcal 15.95 11.17 25 68140 3875 42549295
Neuralgia 15.83 11.17 82 68083 25565 42527605
Ear discomfort 15.61 11.17 23 68142 3376 42549794
Lower respiratory tract infection 15.51 11.17 116 68049 41090 42512080
Dry mouth 15.43 11.17 113 68052 39766 42513404
Night sweats 15.34 11.17 68 68097 19901 42533269
Hypokalaemia 15.21 11.17 61 68104 71660 42481510
Hyperbilirubinaemia 15.15 11.17 7 68158 20628 42532542
Acne 14.98 11.17 52 68113 13592 42539578
Exposure via skin contact 14.94 11.17 28 68137 5010 42548160
Bronchial obstruction 14.85 11.17 16 68149 1713 42551457
Injection site rash 14.81 11.17 30 68135 5682 42547488
Respiratory tract infection 14.78 11.17 82 68083 26240 42526930
Mood swings 14.76 11.17 39 68126 8787 42544383
Restlessness 14.73 11.17 15 68150 29234 42523936
Hypersomnia 14.59 11.17 54 68111 14564 42538606
Procedural pain 14.57 11.17 30 68135 5749 42547421
Shock haemorrhagic 14.50 11.17 4 68161 16238 42536932
Skin striae 14.41 11.17 11 68154 752 42552418
Drug hypersensitivity 14.34 11.17 231 67934 99158 42454012
Poisoning 14.34 11.17 3 68162 14696 42538474
Cardio-respiratory arrest 14.33 11.17 47 68118 58589 42494581
Surgery 14.30 11.17 61 68104 17555 42535615
Hemiparesis 14.22 11.17 5 68160 17371 42535799
Atopy 14.05 11.17 12 68153 963 42552207
Fractional exhaled nitric oxide increased 14.02 11.17 15 68150 1594 42551576
Multiple allergies 14.02 11.17 23 68142 3705 42549465
Rhinalgia 14.01 11.17 16 68149 1828 42551342
Eczema 14.01 11.17 98 68067 33988 42519182
Paranasal sinus hypersecretion 13.97 11.17 13 68152 1168 42552002
Oesophageal candidiasis 13.91 11.17 29 68136 5606 42547564
Malaise 13.73 11.17 440 67725 211716 42341454
Viral myelitis 13.71 11.17 5 68160 71 42553099
Cerebral haemorrhage 13.60 11.17 26 68139 38940 42514230
Synovitis 13.59 11.17 4 68161 15563 42537607
Product preparation error 13.48 11.17 26 68139 4752 42548418
Growth retardation 13.47 11.17 18 68147 2414 42550756
Rectal haemorrhage 13.38 11.17 38 68127 49568 42503602
Inhalation therapy 13.37 11.17 4 68161 29 42553141
Hepatocellular injury 13.28 11.17 11 68154 23667 42529503
Blood urea increased 13.17 11.17 20 68145 32773 42520397
Stress 13.16 11.17 118 68047 44094 42509076
Feeling cold 13.01 11.17 48 68117 12925 42540245
Pancreatic failure 12.92 11.17 12 68153 1075 42552095
Throat irritation 12.88 11.17 48 68117 12988 42540182
Meralgia paraesthetica 12.87 11.17 6 68159 163 42553007
Cystic fibrosis respiratory infection suppression 12.81 11.17 7 68158 268 42552902
Transplant rejection 12.79 11.17 3 68162 13585 42539585
Tachycardia 12.72 11.17 102 68063 100985 42452185
Poor quality device used 12.57 11.17 13 68152 1328 42551842
Ageusia 12.55 11.17 44 68121 11561 42541609
Ventricular tachycardia 12.50 11.17 18 68147 30142 42523028
Proteinuria 12.49 11.17 11 68154 22972 42530198
Contusion 12.46 11.17 112 68053 41873 42511297
Shock 12.45 11.17 17 68148 29104 42524066
Central obesity 12.42 11.17 10 68155 739 42552431
Nasal polypectomy 12.41 11.17 4 68161 38 42553132
Skin haemorrhage 12.34 11.17 34 68131 7851 42545319
Hand-foot-and-mouth disease 12.26 11.17 7 68158 292 42552878
Migraine 12.22 11.17 76 68089 25338 42527832
Lipohypertrophy 12.18 11.17 7 68158 296 42552874
Subarachnoid haemorrhage 12.13 11.17 4 68161 14468 42538702
Anger 12.09 11.17 47 68118 12971 42540199
Electrocardiogram QT prolonged 12.01 11.17 38 68127 47907 42505263
Hyperthyroidism 11.95 11.17 4 68161 14337 42538833
Mood altered 11.90 11.17 41 68124 10677 42542493
Periorbital pain 11.89 11.17 4 68161 44 42553126
Liver injury 11.89 11.17 8 68157 19140 42534030
Injection site discolouration 11.83 11.17 15 68150 1911 42551259
Rheumatoid arthritis 11.82 11.17 32 68133 42408 42510762
Sensory disturbance 11.71 11.17 31 68134 6992 42546178
Generalised tonic-clonic seizure 11.68 11.17 15 68150 26364 42526806
Exostosis 11.65 11.17 27 68138 5604 42547566
Bladder operation 11.61 11.17 6 68159 205 42552965
Neck pain 11.58 11.17 85 68080 29929 42523241
Hypocalcaemia 11.55 11.17 19 68146 30154 42523016
Injection site mass 11.51 11.17 35 68130 8540 42544630
Cystitis 11.50 11.17 43 68122 11655 42541515
Pneumocystis jirovecii pneumonia 11.49 11.17 14 68151 25167 42528003
Hot flush 11.48 11.17 68 68097 22283 42530887
Intentional dose omission 11.43 11.17 36 68129 8950 42544220
Antineutrophil cytoplasmic antibody positive 11.41 11.17 23 68142 4342 42548828
Neoplasm progression 11.35 11.17 18 68147 28982 42524188
Thrombosis 11.33 11.17 163 68002 68348 42484822
IPEX syndrome 11.32 11.17 3 68162 13 42553157
Nasal septum deviation 11.29 11.17 12 68153 1266 42551904
Deformity thorax 11.22 11.17 4 68161 53 42553117

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 1267.95 9.58 1837 187861 248454 110151147
Toxicity to various agents 519.01 9.58 98 189600 480457 109919144
Cough 493.46 9.58 1825 187873 459816 109939785
Wheezing 345.93 9.58 1093 188605 254137 110145464
Completed suicide 320.89 9.58 25 189673 242356 110157245
Dyspnoea 318.83 9.58 3093 186605 1103779 109295822
Nasal congestion 278.86 9.58 558 189140 97724 110301877
Acute kidney injury 276.42 9.58 414 189284 635016 109764585
Upper respiratory tract infection 246.70 9.58 633 189065 130695 110268906
Chest discomfort 243.24 9.58 753 188945 173095 110226506
Infective pulmonary exacerbation of cystic fibrosis 238.63 9.58 200 189498 14571 110385030
Food allergy 227.44 9.58 222 189476 19726 110379875
Chronic sinusitis 224.29 9.58 245 189453 24839 110374762
Productive cough 224.12 9.58 560 189138 113745 110285856
Product dose omission issue 208.54 9.58 1096 188602 320686 110078915
Bronchitis 208.48 9.58 668 189030 156364 110243237
Temperature regulation disorder 195.58 9.58 168 189530 12658 110386943
Eosinophilic granulomatosis with polyangiitis 187.91 9.58 152 189546 10534 110389067
Foetal death 183.74 9.58 179 189519 15866 110383735
Hand deformity 181.00 9.58 74 189624 218432 110181169
Febrile neutropenia 180.90 9.58 166 189532 316601 110083000
Neutropenia 180.89 9.58 226 189472 374394 110025207
Dermatitis atopic 180.53 9.58 221 189477 25320 110374281
Obstructive airways disorder 178.98 9.58 300 189398 45849 110353752
Synovitis 172.06 9.58 131 189567 273961 110125640
Drug abuse 162.39 9.58 51 189647 177360 110222241
Female genital tract fistula 161.18 9.58 169 189529 16350 110383251
Systemic lupus erythematosus 147.92 9.58 131 189567 254207 110145394
Nasal polyps 146.93 9.58 145 189553 13055 110386546
Chronic obstructive pulmonary disease 145.43 9.58 465 189233 108693 110290908
Pemphigus 144.59 9.58 95 189603 214475 110185126
Off label use 143.82 9.58 1767 187931 1498418 108901183
Drug interaction 142.09 9.58 415 189283 499768 109899833
Full blood count abnormal 139.91 9.58 302 189396 55750 110343851
General physical health deterioration 138.16 9.58 330 189368 424965 109974636
Sinusitis 134.68 9.58 921 188777 295767 110103834
Macular degeneration 133.41 9.58 175 189523 21484 110378117
Intentional overdose 130.70 9.58 33 189665 132468 110267133
Myelosuppression 129.83 9.58 8 189690 94332 110305269
Immunodeficiency 125.42 9.58 233 189465 38605 110360996
Procedural pain 124.54 9.58 221 189477 35344 110364257
Vaginal flatulence 121.64 9.58 126 189572 12018 110387583
Sleep disorder due to a general medical condition 120.16 9.58 272 189426 51840 110347761
Malignant neoplasm progression 116.64 9.58 78 189620 174489 110225112
Pancytopenia 115.92 9.58 113 189585 209500 110190101
Paraesthesia oral 113.77 9.58 206 189492 33465 110366136
Pericarditis 113.41 9.58 125 189573 218989 110180612
Glossodynia 112.34 9.58 129 189569 221875 110177726
Illness 112.14 9.58 353 189345 81818 110317783
Oral candidiasis 111.52 9.58 241 189457 44519 110355082
Drug-induced liver injury 110.79 9.58 34 189664 120033 110279568
Pneumonia 109.74 9.58 2111 187587 874603 109524998
Anti-cyclic citrullinated peptide antibody positive 109.12 9.58 91 189607 181893 110217708
Helicobacter infection 107.76 9.58 92 189606 181785 110217816
Duodenal ulcer perforation 105.15 9.58 90 189608 177610 110221991
Impaired quality of life 104.43 9.58 186 189512 29831 110369770
Vaginal discharge 103.10 9.58 140 189558 17768 110381833
Sleep apnoea syndrome 102.17 9.58 219 189479 40228 110359373
Headache 102.16 9.58 2100 187598 880277 109519324
Dysphonia 101.62 9.58 324 189374 75605 110323996
Fluid retention 101.33 9.58 374 189324 93933 110305668
Wound 100.49 9.58 154 189544 234283 110165318
Confusional state 99.69 9.58 439 189259 468241 109931360
Sputum increased 99.42 9.58 81 189617 5670 110393931
Radiculopathy 99.16 9.58 143 189555 19193 110380408
Injection site pain 98.44 9.58 581 189117 177341 110222260
Rhinorrhoea 97.90 9.58 392 189306 102274 110297327
Product quality issue 97.28 9.58 323 189375 76976 110322625
Arthropathy 95.79 9.58 220 189478 287302 110112299
Sleep disorder due to general medical condition, insomnia type 95.54 9.58 31 189667 105612 110293989
Proctitis 93.93 9.58 130 189568 16797 110382804
Renal impairment 91.60 9.58 113 189585 188332 110211269
Mucosal inflammation 90.94 9.58 26 189672 96115 110303486
Gastrooesophageal reflux disease 90.90 9.58 574 189124 179402 110220199
Dyspnoea exertional 88.78 9.58 384 189314 103676 110295925
Rash erythematous 88.31 9.58 325 189373 81507 110318094
Sputum discoloured 88.17 9.58 166 189532 27779 110371822
Influenza 87.07 9.58 542 189156 168559 110231042
Adrenal suppression 86.68 9.58 47 189651 1649 110397952
Coma 86.67 9.58 47 189651 117822 110281779
Seasonal allergy 84.31 9.58 134 189564 19588 110380013
Therapeutic product effect incomplete 83.36 9.58 663 189035 223142 110176459
Bronchial neoplasm 82.51 9.58 32 189666 504 110399097
Metabolic acidosis 82.21 9.58 34 189664 99710 110299891
Middle insomnia 81.79 9.58 135 189563 20367 110379234
Oropharyngeal pain 81.55 9.58 452 189246 134824 110264777
Forced expiratory volume decreased 80.44 9.58 106 189592 13070 110386531
Nasal turbinate hypertrophy 77.94 9.58 35 189663 809 110398792
Eczema 77.91 9.58 287 189411 72006 110327595
Hepatic function abnormal 77.63 9.58 28 189670 89267 110310334
Dry skin 77.55 9.58 378 189320 107275 110292326
Eosinophil count increased 76.51 9.58 133 189565 20925 110378676
Folliculitis 75.87 9.58 106 189592 167547 110232054
Muscle injury 75.44 9.58 78 189620 140729 110258872
Gastrointestinal disorder 75.16 9.58 192 189506 241760 110157841
Liver injury 74.36 9.58 89 189609 150324 110249277
Delirium 73.25 9.58 74 189624 134951 110264650
Upper-airway cough syndrome 72.32 9.58 111 189587 15746 110383855
Ill-defined disorder 72.16 9.58 98 189600 156755 110242846
Alopecia 71.98 9.58 351 189347 364402 110035199
Hepatic cytolysis 71.92 9.58 6 189692 55047 110344554
Depressed level of consciousness 71.26 9.58 53 189645 112225 110287376
Hyperkalaemia 70.76 9.58 77 189621 135719 110263882
C-reactive protein increased 70.76 9.58 169 189529 217750 110181851
Pain 70.47 9.58 2139 187559 952816 109446785
Swollen joint count increased 69.79 9.58 28 189670 83633 110315968
Respiratory tract infection 68.71 9.58 274 189424 71343 110328258
Impaired healing 68.38 9.58 147 189551 196570 110203031
Hypotension 68.05 9.58 573 189125 523276 109876325
Coeliac disease 67.85 9.58 195 189503 42992 110356609
Musculoskeletal stiffness 65.75 9.58 252 189446 279570 110120031
Gastrointestinal procedural complication 65.39 9.58 26 189672 439 110399162
Septic shock 65.09 9.58 106 189592 157422 110242179
Endometrial ablation 64.97 9.58 32 189666 916 110398685
Feeling abnormal 64.92 9.58 531 189167 180180 110219421
Anxiety 64.73 9.58 889 188809 344189 110055412
Cystic fibrosis 64.19 9.58 58 189640 4673 110394928
Interstitial lung disease 64.15 9.58 87 189611 139247 110260354
Hepatotoxicity 64.06 9.58 15 189683 63385 110336216
Constipation 63.60 9.58 913 188785 356873 110042728
Therapy non-responder 63.01 9.58 108 189590 157199 110242402
Eye pruritus 62.55 9.58 159 189539 32616 110366985
Anosmia 62.15 9.58 91 189607 12381 110387220
Weight decreased 62.14 9.58 1138 188560 466919 109932682
Agranulocytosis 61.64 9.58 15 189683 61745 110337856
Bradycardia 61.17 9.58 108 189590 155409 110244192
Cytomegalovirus infection 61.07 9.58 10 189688 54434 110345167
Rhonchi 60.54 9.58 55 189643 4463 110395138
Disease progression 60.46 9.58 215 189483 243819 110155782
Back pain 60.20 9.58 932 188766 370064 110029537
Product administration interrupted 60.09 9.58 85 189613 11207 110388394
Therapeutic product effect decreased 60.03 9.58 216 189482 244100 110155501
Drug reaction with eosinophilia and systemic symptoms 59.97 9.58 33 189665 82062 110317539
Salpingo-oophorectomy unilateral 59.80 9.58 29 189669 802 110398799
Chest pain 59.74 9.58 942 188756 375433 110024168
Thrombocytopenia 58.74 9.58 354 189344 348531 110051070
Rhabdomyolysis 58.71 9.58 72 189626 120329 110279272
Blister 58.57 9.58 197 189501 227179 110172422
Stress 58.23 9.58 344 189354 105004 110294597
Viral infection 58.13 9.58 212 189486 52927 110346674
Injection site erythema 57.63 9.58 316 189382 93860 110305741
Exposure via skin contact 57.12 9.58 90 189608 13057 110386544
Rhinitis 56.86 9.58 122 189576 22423 110377178
Cardio-respiratory arrest 56.76 9.58 69 189629 115767 110283834
Intentional product use issue 56.49 9.58 226 189472 247680 110151921
Vision blurred 56.38 9.58 397 189301 128625 110270976
Bronchial haemorrhage 56.16 9.58 33 189665 1354 110398247
Platelet count decreased 55.78 9.58 205 189493 230238 110169363
Multiple organ dysfunction syndrome 54.72 9.58 111 189587 151599 110248002
Hyperhidrosis 54.70 9.58 526 189172 186772 110212829
Injection site swelling 53.45 9.58 229 189469 61561 110338040
Oesophageal spasm 51.83 9.58 46 189652 3620 110395981
Multi-organ disorder 50.97 9.58 44 189654 3337 110396264
Bone marrow failure 50.52 9.58 18 189680 57830 110341771
Altered state of consciousness 50.21 9.58 18 189680 57608 110341993
Electrocardiogram QT prolonged 50.19 9.58 68 189630 108892 110290709
Lactic acidosis 50.18 9.58 51 189647 92760 110306841
Cholestasis 50.01 9.58 24 189674 64494 110335107
Irritable bowel syndrome 49.69 9.58 132 189566 164083 110235518
Renal failure 49.47 9.58 210 189488 226364 110173237
Breath sounds abnormal 49.27 9.58 124 189574 25280 110374321
Decreased immune responsiveness 49.19 9.58 71 189627 9535 110390066
Injection site pruritus 49.08 9.58 196 189502 51062 110348539
Cytokine release syndrome 48.88 9.58 30 189668 70276 110329325
Sinus disorder 48.75 9.58 145 189553 32583 110367018
Nasal oedema 48.04 9.58 59 189639 6780 110392821
Leukopenia 47.81 9.58 116 189582 148675 110250926
Maternal exposure during pregnancy 47.57 9.58 250 189448 254633 110144968
Respiratory symptom 47.42 9.58 89 189609 14856 110384745
Rash maculo-papular 47.14 9.58 35 189663 74187 110325414
Hypokalaemia 47.03 9.58 158 189540 182290 110217311
C-reactive protein abnormal 46.68 9.58 95 189603 129600 110270001
Increased upper airway secretion 46.59 9.58 51 189647 5181 110394420
Mobility decreased 46.50 9.58 229 189469 237193 110162408
Sinusitis fungal 46.37 9.58 38 189660 2682 110396919
Nasal discomfort 46.15 9.58 55 189643 6126 110393475
Toxic epidermal necrolysis 45.68 9.58 20 189678 56707 110342894
Pneumocystis jirovecii pneumonia 45.44 9.58 9 189689 42726 110356875
Product complaint 45.33 9.58 84 189614 13888 110385713
Prolonged expiration 45.33 9.58 30 189668 1522 110398079
Bladder prolapse 44.86 9.58 29 189669 1413 110398188
Drug ineffective 44.59 9.58 2144 187554 1518396 108881205
COVID-19 44.57 9.58 628 189070 244432 110155169
Serotonin syndrome 44.35 9.58 23 189675 59130 110340471
Gamma-glutamyltransferase increased 44.27 9.58 25 189673 61284 110338317
Emotional distress 44.16 9.58 173 189525 44674 110354927
Bronchial disorder 43.63 9.58 37 189661 2739 110396862
Injection site bruising 43.58 9.58 189 189509 51074 110348527
Heart sounds 43.17 9.58 26 189672 1117 110398484
Pulmonary function test decreased 42.66 9.58 63 189635 8637 110390964
Cushing's syndrome 42.66 9.58 24 189674 906 110398695
Sopor 42.62 9.58 6 189692 36540 110363061
Cardiac failure 42.13 9.58 172 189526 187454 110212147
Hiatus hernia 41.78 9.58 123 189575 27483 110372118
Neutrophil count decreased 41.50 9.58 91 189607 120850 110278751
Rheumatic fever 41.43 9.58 93 189605 122486 110277115
Posterior reversible encephalopathy syndrome 40.83 9.58 5 189693 33856 110365745
Oesophageal pain 40.59 9.58 47 189651 5078 110394523
Deep vein thrombosis postoperative 40.26 9.58 26 189672 59265 110340336
Throat clearing 39.92 9.58 43 189655 4290 110395311
Psoriatic arthropathy 39.56 9.58 188 189510 196573 110203028
Malaise 39.52 9.58 1466 188232 670353 109729248
Tubulointerstitial nephritis 39.39 9.58 22 189676 54262 110345339
Drug resistance 39.27 9.58 24 189674 56350 110343251
Nasal discharge discolouration 39.08 9.58 37 189661 3164 110396437
Therapy partial responder 39.00 9.58 8 189690 37053 110362548
Labelled drug-drug interaction medication error 38.81 9.58 3 189695 29299 110370302
Poor quality device used 38.65 9.58 35 189663 2828 110396773
Hip arthroplasty 38.55 9.58 24 189674 55789 110343812
Ear discomfort 38.22 9.58 69 189629 11180 110388421
Decreased appetite 38.21 9.58 580 189118 475266 109924335
Extrapyramidal disorder 38.11 9.58 3 189695 28864 110370737
Blood immunoglobulin E increased 37.88 9.58 55 189643 7427 110392174
Emphysema 37.86 9.58 96 189602 19660 110379941
Suicide attempt 37.83 9.58 75 189623 103319 110296282
Autoimmune disorder 37.71 9.58 34 189664 65449 110334152
Multiple allergies 37.64 9.58 72 189626 12191 110387410
Injection site urticaria 37.63 9.58 88 189610 17127 110382474
Blood pressure inadequately controlled 37.04 9.58 55 189643 7578 110392023
Erythema 37.03 9.58 704 188994 290743 110108858
Concussion 36.97 9.58 69 189629 11469 110388132
Anaemia 36.10 9.58 691 189007 546395 109853206
Discomfort 36.04 9.58 218 189480 214489 110185112
Rheumatoid factor positive 36.02 9.58 111 189587 131529 110268072
Poisoning 35.83 9.58 4 189694 29101 110370500
Eosinophilic bronchitis 34.94 9.58 18 189680 568 110399033
Embolism venous 34.74 9.58 43 189655 4980 110394621
Swelling 34.67 9.58 410 189288 350631 110048970
Type 2 diabetes mellitus 34.67 9.58 171 189527 177061 110222540
Neuroleptic malignant syndrome 34.52 9.58 8 189690 34051 110365550
Blood creatinine increased 34.33 9.58 179 189519 182710 110216891
Pruritus 34.17 9.58 1269 188429 580291 109819310
Injection site rash 34.16 9.58 103 189595 23316 110376285
Infusion site reaction 33.97 9.58 86 189612 17596 110382005
Prescribed underdose 33.90 9.58 37 189661 65137 110334464
Death 33.64 9.58 927 188771 697942 109701659
Neck pain 33.60 9.58 341 189357 122789 110276812
Sinus operation 33.56 9.58 33 189665 2958 110396643
Dry eye 33.32 9.58 186 189512 55607 110343994
Lip dry 32.96 9.58 77 189621 100006 110299595
Ear infection 32.85 9.58 202 189496 62530 110337071
Hepatic enzyme increased 32.77 9.58 372 189326 320520 110079081
Contraindicated product administered 32.43 9.58 271 189427 247996 110151605
Facial discomfort 32.43 9.58 15 189683 372 110399229
Bronchial hyperreactivity 32.35 9.58 35 189663 3509 110396092
Paranasal sinus discomfort 32.30 9.58 47 189651 6358 110393243
Rhinitis allergic 32.20 9.58 85 189613 17837 110381764
Hepatocellular injury 32.01 9.58 24 189674 50618 110348983
Depression 31.99 9.58 741 188957 316594 110083007
Bronchospasm 31.70 9.58 119 189579 30120 110369481
Sedation 31.57 9.58 44 189654 69639 110329962
Inflammation 31.49 9.58 198 189500 193040 110206561
Eye irritation 31.29 9.58 127 189571 33325 110366276
Dermatitis allergic 31.18 9.58 95 189603 21629 110377972
Bronchial obstruction 30.93 9.58 32 189666 3047 110396554
Nephropathy toxic 30.92 9.58 5 189693 27473 110372128
Intentional product misuse 30.69 9.58 356 189342 132548 110267053
Cholecystitis chronic 30.67 9.58 57 189641 9443 110390158
Sciatica 30.50 9.58 71 189627 92328 110307273
Oxygen saturation decreased 30.45 9.58 407 189291 156575 110243026
Acute sinusitis 30.39 9.58 41 189657 5170 110394431
Alanine aminotransferase increased 30.10 9.58 188 189510 183585 110216016
Tumour lysis syndrome 29.74 9.58 8 189690 30793 110368808
Neutropenic sepsis 29.66 9.58 8 189690 30738 110368863
Prescribed overdose 29.65 9.58 254 189444 87327 110312274
Hepatic failure 29.58 9.58 45 189653 68694 110330907
Decreased activity 29.55 9.58 61 189637 10913 110388688
Eosinophil count abnormal 29.54 9.58 20 189678 1054 110398547
Aphonia 29.50 9.58 67 189631 12793 110386808
Grip strength decreased 29.47 9.58 58 189640 80116 110319485
Respiration abnormal 29.38 9.58 57 189641 9752 110389849
Cardiac arrest 29.35 9.58 207 189491 196546 110203055
Infusion site erythema 29.34 9.58 64 189634 11895 110387706
Thrombotic microangiopathy 29.24 9.58 7 189691 29142 110370459
Hysterectomy 29.15 9.58 51 189647 8063 110391538
Acute respiratory distress syndrome 29.02 9.58 29 189669 53169 110346432
Eye haemorrhage 28.87 9.58 63 189635 11711 110387890
Psoriasis 28.84 9.58 367 189331 139626 110259975
Adjustment disorder with depressed mood 28.77 9.58 20 189678 43863 110355738
Shock haemorrhagic 28.43 9.58 6 189692 27241 110372360
Drug level increased 28.42 9.58 24 189674 47695 110351906
Surgery 28.33 9.58 143 189555 41140 110358461
Deep vein thrombosis 28.10 9.58 365 189333 139522 110260079
Status asthmaticus 28.05 9.58 19 189679 1002 110398599
Eosinophil count 27.98 9.58 11 189687 180 110399421
Infusion site swelling 27.90 9.58 56 189642 9821 110389780
Retching 27.83 9.58 94 189604 22588 110377013
Incorrect dose administered 27.79 9.58 286 189412 103355 110296246
Finger deformity 27.72 9.58 11 189687 33081 110366520
Drug ineffective for unapproved indication 27.23 9.58 88 189610 102750 110296851
Miosis 27.12 9.58 3 189695 21980 110377621
Chorioretinopathy 27.02 9.58 26 189672 2269 110397332
Acute respiratory failure 26.93 9.58 221 189477 75039 110324562
Treatment failure 26.90 9.58 325 189373 276909 110122692
Tinnitus 26.86 9.58 187 189511 60353 110339248
Toxic skin eruption 26.84 9.58 7 189691 27508 110372093
Heart rate increased 26.70 9.58 370 189328 143464 110256137
Diastolic dysfunction 26.67 9.58 63 189635 12341 110387260
Gastroenteritis viral 26.44 9.58 115 189583 31111 110368490
Frequent bowel movements 26.28 9.58 211 189487 71179 110328422
Drug eruption 26.24 9.58 32 189666 53627 110345974
Joint swelling 25.74 9.58 571 189127 442274 109957327
Respiratory tract congestion 25.64 9.58 113 189585 30744 110368857
Rales 25.64 9.58 97 189601 24642 110374959
Blood lactate dehydrogenase increased 25.55 9.58 23 189675 44311 110355290
Ischaemic stroke 25.51 9.58 20 189678 41243 110358358
Acute myeloid leukaemia 25.48 9.58 17 189681 38093 110361508
Drug tolerance decreased 25.04 9.58 8 189690 27532 110372069
Product dose omission in error 25.04 9.58 93 189605 23419 110376182
Allergy to animal 25.04 9.58 23 189675 1893 110397708
Pharyngitis streptococcal 24.91 9.58 64 189634 13213 110386388
Sinus congestion 24.90 9.58 111 189587 30348 110369253
Eye disorder 24.89 9.58 107 189591 28799 110370802
Urticaria 24.68 9.58 719 188979 318138 110081463
Oesophagogastroduodenoscopy 24.62 9.58 11 189687 251 110399350
Rectal prolapse 24.61 9.58 26 189672 2537 110397064
Exercise tolerance decreased 24.56 9.58 60 189638 12007 110387594
Transplant rejection 24.45 9.58 6 189692 24561 110375040
Sinus headache 24.44 9.58 40 189658 5992 110393609
Haemoglobin decreased 24.35 9.58 291 189407 248436 110151165
Diverticulum 24.28 9.58 70 189628 15456 110384145
Hypocalcaemia 24.27 9.58 47 189651 65319 110334282
Cerebral infarction 24.22 9.58 32 189666 51806 110347795
Depressed mood 24.20 9.58 183 189515 60626 110338975
Joint range of motion decreased 24.14 9.58 117 189581 121715 110277886
Shock 24.12 9.58 34 189664 53554 110346047
Pulmonary embolism 23.87 9.58 508 189190 213966 110185635
Eye swelling 23.76 9.58 116 189582 32932 110366669
Foot deformity 23.62 9.58 29 189669 48451 110351150
Stomatitis 23.56 9.58 324 189374 269918 110129683
Pre-existing condition improved 23.42 9.58 41 189657 6485 110393116
Onychomycosis 23.41 9.58 19 189679 38512 110361089
Jaundice 23.41 9.58 41 189657 59195 110340406
Dyspnoea paroxysmal nocturnal 23.35 9.58 25 189673 2477 110397124
Chest injury 23.29 9.58 29 189669 3380 110396221
Lower limb fracture 23.22 9.58 60 189638 75288 110324313
Loss of personal independence in daily activities 23.20 9.58 374 189324 149646 110249955
Vitamin D decreased 23.04 9.58 59 189639 12156 110387445
Feeling cold 22.81 9.58 117 189581 33870 110365731
Palmar-plantar erythrodysaesthesia syndrome 22.80 9.58 22 189676 41003 110358598
Fractional exhaled nitric oxide increased 22.66 9.58 15 189683 761 110398840
Melaena 22.56 9.58 53 189645 68704 110330897
Swelling face 22.53 9.58 250 189448 92071 110307530
Lupus-like syndrome 22.52 9.58 22 189676 40770 110358831
Ankle fracture 22.46 9.58 80 189618 19739 110379862
C-reactive protein 22.43 9.58 12 189686 30319 110369282
Biliary dyskinesia 22.26 9.58 24 189674 2397 110397204
Anuria 22.26 9.58 7 189691 24334 110375267
Ocular hyperaemia 22.16 9.58 129 189569 39157 110360444
Infusion site pain 22.09 9.58 73 189625 17346 110382255
Sepsis 22.01 9.58 412 189286 326934 110072667
Brain oedema 21.99 9.58 13 189685 31085 110368516
Migraine 21.91 9.58 415 189283 171237 110228364
Neurotoxicity 21.91 9.58 24 189674 42183 110357418
Blood creatine phosphokinase increased 21.90 9.58 59 189639 73018 110326583
Eosinophilic pneumonia chronic 21.68 9.58 13 189685 554 110399047
Bursitis 21.65 9.58 328 189370 129590 110270011
Torsade de pointes 21.58 9.58 6 189692 22594 110377007
Hyposmia 21.58 9.58 17 189681 1134 110398467
Hyperthermia 21.55 9.58 5 189693 21267 110378334
Blood corticotrophin 21.48 9.58 4 189694 0 110399601
Pulmonary fibrosis 21.39 9.58 96 189602 101946 110297655
Cerebral haemorrhage 21.38 9.58 50 189648 64918 110334683
Throat irritation 21.22 9.58 161 189537 53391 110346210
Injection site inflammation 21.20 9.58 33 189665 4738 110394863
Drug use disorder 21.00 9.58 3 189695 18071 110381530
Burning sensation 21.00 9.58 196 189502 69016 110330585
Mydriasis 20.93 9.58 6 189692 22151 110377450
Acute hepatic failure 20.92 9.58 19 189679 36449 110363152
Nasopharyngitis 20.88 9.58 851 188847 393510 110006091
Insurance issue 20.79 9.58 52 189646 10560 110389041
Cortisol decreased 20.79 9.58 25 189673 2811 110396790
Increased viscosity of bronchial secretion 20.49 9.58 13 189685 613 110398988
Hypoglycaemia 20.48 9.58 116 189582 115988 110283613
Hypertrophic osteoarthropathy 20.46 9.58 8 189690 129 110399472
No adverse event 20.39 9.58 205 189493 73634 110325967
Facet joint syndrome 20.35 9.58 91 189607 96737 110302864
Hypersensitivity 20.30 9.58 867 188831 403131 109996470
Hypomagnesaemia 20.24 9.58 46 189652 60324 110339277
Acute generalised exanthematous pustulosis 20.22 9.58 6 189692 21658 110377943
Granuloma 20.19 9.58 48 189650 9442 110390159
Haemoptysis 20.13 9.58 199 189499 71155 110328446
Rheumatoid nodule 20.11 9.58 5 189693 20291 110379310
Liver disorder 20.08 9.58 152 189546 142091 110257510
Ligament sprain 20.08 9.58 67 189631 16001 110383600
Umbilical hernia 20.06 9.58 40 189658 6982 110392619
Sensation of foreign body 19.93 9.58 43 189655 7932 110391669
Vocal cord dysfunction 19.93 9.58 15 189683 935 110398666
Graft versus host disease 19.91 9.58 4 189694 18802 110380799
Forced expiratory flow decreased 19.87 9.58 10 189688 300 110399301
Disseminated intravascular coagulation 19.79 9.58 25 189673 41261 110358340
Palpitations 19.66 9.58 383 189315 158829 110240772
Cystic fibrosis related diabetes 19.65 9.58 9 189689 218 110399383
Painful respiration 19.63 9.58 28 189670 3719 110395882
Akathisia 19.51 9.58 3 189695 17110 110382491
Proteinuria 19.43 9.58 24 189674 39994 110359607
X-ray abnormal 19.43 9.58 22 189676 38095 110361506
Haemophilus infection 19.42 9.58 24 189674 2776 110396825
Fatigue 19.41 9.58 2375 187323 1213583 109186018
Cytopenia 19.38 9.58 14 189684 30102 110369499
Myocarditis 19.31 9.58 14 189684 30041 110369560
Essential hypertension 19.26 9.58 42 189656 7805 110391796
Parkinsonism 19.21 9.58 7 189691 22180 110377421
Nasal inflammation 19.07 9.58 15 189683 998 110398603
Secretion discharge 19.05 9.58 77 189621 20167 110379434
Knee arthroplasty 19.04 9.58 53 189645 64895 110334706
Mite allergy 18.96 9.58 35 189663 5768 110393833
Stevens-Johnson syndrome 18.96 9.58 32 189666 46869 110352732
Hyperbilirubinaemia 18.79 9.58 15 189683 30656 110368945
Adverse reaction 18.73 9.58 14 189684 29580 110370021
Peritonitis 18.69 9.58 17 189681 32590 110367011
Intentional dose omission 18.60 9.58 76 189622 20004 110379597
Lymphopenia 18.56 9.58 25 189673 40145 110359456
Cardiac failure congestive 18.56 9.58 363 189335 150637 110248964
Arthropod bite 18.54 9.58 47 189651 9624 110389977
Inhalation therapy 18.50 9.58 6 189692 54 110399547
Hyperlipidaemia 18.49 9.58 115 189583 35733 110363868
Skin fissures 18.41 9.58 87 189611 24371 110375230
Encephalopathy 18.38 9.58 74 189624 80981 110318620
Respiratory arrest 18.29 9.58 46 189652 58253 110341348
Osteonecrosis of jaw 18.29 9.58 34 189664 47983 110351618
Throat tightness 18.27 9.58 109 189589 33380 110366221
Abdominal discomfort 18.25 9.58 525 189173 393333 110006268
Hyponatraemia 18.24 9.58 263 189435 217390 110182211
Myalgia 18.18 9.58 505 189193 221876 110177725
Generalised tonic-clonic seizure 18.06 9.58 42 189656 54638 110344963
Gout 18.05 9.58 116 189582 36450 110363151
Sneezing 18.03 9.58 105 189593 31879 110367722
Affective disorder 17.89 9.58 51 189647 11190 110388411
Inappropriate antidiuretic hormone secretion 17.84 9.58 19 189679 33832 110365769
Blood glucose increased 17.83 9.58 323 189375 132173 110267428
Hepatic cirrhosis 17.81 9.58 58 189640 67568 110332033
Respiratory syncytial virus infection 17.75 9.58 60 189638 14424 110385177
Growth retardation 17.69 9.58 22 189676 2560 110397041
Circulatory collapse 17.69 9.58 29 189669 42964 110356637
Gluten sensitivity 17.66 9.58 11 189687 502 110399099
Eosinophilic oesophagitis 17.63 9.58 16 189682 1296 110398305
Premature delivery 17.52 9.58 16 189682 30616 110368985
Nasal obstruction 17.51 9.58 25 189673 3325 110396276
Urinary tract infection 17.47 9.58 705 188993 325577 110074024
Haemolytic anaemia 17.45 9.58 7 189691 20913 110378688
Secondary adrenocortical insufficiency 17.42 9.58 29 189669 4405 110395196
Hypertransaminasaemia 17.35 9.58 10 189688 24245 110375356
Ectropion 17.33 9.58 11 189687 519 110399082
Tricuspid valve incompetence 17.31 9.58 84 189614 23789 110375812
Skin exfoliation 17.30 9.58 228 189470 87423 110312178
Neoplasm progression 17.29 9.58 55 189643 64540 110335061
Temperature intolerance 17.28 9.58 58 189640 13892 110385709
Hospitalisation 16.99 9.58 341 189357 142152 110257449
Lung hernia 16.88 9.58 6 189692 73 110399528
Polyneuropathy 16.84 9.58 18 189680 31994 110367607
Peak expiratory flow rate decreased 16.83 9.58 12 189686 688 110398913
Iron deficiency anaemia 16.76 9.58 102 189596 31457 110368144
Eustachian tube dysfunction 16.73 9.58 12 189686 694 110398907
Diabetic ketoacidosis 16.72 9.58 29 189669 42029 110357572
Lymphoedema 16.70 9.58 60 189638 14869 110384732
Candida infection 16.65 9.58 140 189558 47869 110351732
Plethoric face 16.64 9.58 5 189693 34 110399567
Cushingoid 16.60 9.58 51 189647 11661 110387940
Epidural lipomatosis 16.44 9.58 19 189679 2048 110397553
Cytomegalovirus viraemia 16.44 9.58 5 189693 17759 110381842
Overdose 16.42 9.58 292 189406 233502 110166099
Pulmonary mass 16.42 9.58 115 189583 37186 110362415
Foreign body in throat 16.36 9.58 14 189684 1049 110398552
Thyroid disorder 16.33 9.58 65 189633 16904 110382697
Pathogen resistance 16.30 9.58 5 189693 17667 110381934
Snoring 16.30 9.58 36 189662 6748 110392853
Suffocation feeling 16.26 9.58 19 189679 2072 110397529
Skin swelling 16.26 9.58 40 189658 8040 110391561
Blood bilirubin increased 16.21 9.58 71 189627 75901 110323700
Carcinoid tumour of the gastrointestinal tract 16.20 9.58 7 189691 147 110399454
Hepatitis cholestatic 16.15 9.58 5 189693 17561 110382040
Purpura 16.14 9.58 11 189687 24377 110375224
Fracture displacement 16.07 9.58 16 189682 1456 110398145
Tooth infection 15.98 9.58 78 189620 22138 110377463
Hypothermia 15.94 9.58 13 189685 26289 110373312
Disease recurrence 15.94 9.58 167 189531 60617 110338984
Musculoskeletal chest pain 15.81 9.58 94 189604 28753 110370848
Dislocation of vertebra 15.75 9.58 32 189666 43689 110355912
Aspartate aminotransferase increased 15.69 9.58 187 189511 159749 110239852
Drug intolerance 15.68 9.58 555 189143 405957 109993644
Lemierre syndrome 15.58 9.58 7 189691 162 110399439
Dermatitis contact 15.54 9.58 56 189642 13897 110385704
Thermal burn 15.50 9.58 39 189659 7949 110391652
Adverse event 15.49 9.58 116 189582 108693 110290908
Pregnancy 15.48 9.58 41 189657 51026 110348575
Dystonia 15.34 9.58 13 189685 25792 110373809
Hypercalcaemia 15.28 9.58 36 189662 46621 110352980
Oral herpes 15.16 9.58 110 189588 35970 110363631
Anaphylactic shock 15.16 9.58 42 189656 51504 110348097
Enterococcal infection 15.14 9.58 8 189690 20358 110379243
Haematuria 15.14 9.58 82 189616 82923 110316678
Eustachian tube disorder 15.11 9.58 6 189692 101 110399500
Product preparation error 15.08 9.58 47 189651 10832 110388769
Infusion site pruritus 14.87 9.58 29 189669 4979 110394622
Hypothalamic pituitary adrenal axis suppression 14.82 9.58 11 189687 671 110398930
Upper limb fracture 14.79 9.58 73 189625 20815 110378786
Wrong technique in device usage process 14.78 9.58 35 189663 6866 110392735
Respiratory disorder 14.64 9.58 187 189511 71195 110328406
Chronic respiratory failure 14.63 9.58 25 189673 3878 110395723
Psychotic disorder 14.61 9.58 42 189656 50895 110348706
Maternal exposure timing unspecified 14.56 9.58 9 189689 21004 110378597
Croup infectious 14.50 9.58 13 189685 1037 110398564
Metastases to lung 14.48 9.58 11 189687 23052 110376549
Epstein-Barr virus infection 14.47 9.58 7 189691 18731 110380870
FEV1/FVC ratio decreased 14.42 9.58 8 189690 294 110399307
Cholangitis 14.40 9.58 5 189693 16330 110383271
Bronchopulmonary aspergillosis 14.40 9.58 18 189680 29845 110369756
Tooth abscess 14.26 9.58 67 189631 18722 110380879
Creatinine renal clearance decreased 14.23 9.58 10 189688 21805 110377796
Sensitive skin 14.21 9.58 24 189674 3688 110395913
Metastases to central nervous system 14.18 9.58 11 189687 22806 110376795
Hemiplegia 14.14 9.58 11 189687 22771 110376830
Tachycardia 14.09 9.58 289 189409 226356 110173245
Hand fracture 14.06 9.58 38 189660 8084 110391517
Ear canal erythema 14.05 9.58 5 189693 61 110399540
Appendicolith 14.04 9.58 55 189643 14200 110385401
Metastases to bone 14.02 9.58 20 189678 31352 110368249
Cystitis 13.97 9.58 174 189524 65862 110333739
Acne 13.97 9.58 102 189596 33418 110366183
Infusion site mass 13.94 9.58 16 189682 1712 110397889
Mood altered 13.94 9.58 73 189625 21302 110378299
Inappropriate schedule of product administration 13.83 9.58 452 189246 203185 110196416
Pancreatitis acute 13.68 9.58 55 189643 60219 110339382
Transaminases increased 13.67 9.58 59 189639 63331 110336270
Stress cardiomyopathy 13.66 9.58 5 189693 15801 110383800
Hyperphosphataemia 13.62 9.58 60 189638 16321 110383280
Neuralgia 13.58 9.58 135 189563 48343 110351258
Seronegative arthritis 13.55 9.58 3 189695 13174 110386427
Scratch 13.54 9.58 51 189647 12928 110386673
Fracture pain 13.51 9.58 13 189685 1135 110398466
BK virus infection 13.44 9.58 3 189695 13103 110386498
Hypoalbuminaemia 13.42 9.58 18 189680 28956 110370645
Lacrimation increased 13.37 9.58 95 189603 30855 110368746
Capnocytophaga sepsis 13.34 9.58 4 189694 27 110399574
Foreign body in reproductive tract 13.33 9.58 12 189686 962 110398639
Electrocardiogram QRS complex prolonged 13.31 9.58 3 189695 13018 110386583
Cataplexy 13.31 9.58 13 189685 1156 110398445
Product taste abnormal 13.27 9.58 19 189679 2533 110397068
Therapeutic response unexpected 13.26 9.58 78 189620 23765 110375836
Vitamin D deficiency 13.25 9.58 65 189633 18487 110381114
Limb injury 13.18 9.58 110 189588 37526 110362075
Progressive multifocal leukoencephalopathy 13.16 9.58 14 189684 24942 110374659
Sunburn 13.10 9.58 26 189672 4522 110395079
Body mass index increased 13.09 9.58 18 189680 2312 110397289
Rib fracture 13.08 9.58 101 189597 33669 110365932
Expiratory reserve volume decreased 13.08 9.58 6 189692 146 110399455
Hereditary angioedema 13.04 9.58 34 189664 7080 110392521
Haemodynamic instability 13.04 9.58 12 189686 22876 110376725
Hypervolaemia 13.02 9.58 136 189562 49324 110350277
Restlessness 12.98 9.58 51 189647 56208 110343393
Drug hypersensitivity 12.97 9.58 925 188773 453165 109946436
Otitis media 12.97 9.58 35 189663 7441 110392160
Accidental exposure to product 12.93 9.58 137 189561 49871 110349730
Oliguria 12.91 9.58 8 189690 18649 110380952
Uterine perforation 12.86 9.58 33 189665 6807 110392794
Polyp 12.82 9.58 42 189656 9938 110389663
Product label confusion 12.79 9.58 12 189686 22665 110376936
Febrile bone marrow aplasia 12.78 9.58 7 189691 17458 110382143
Hemiparesis 12.74 9.58 36 189662 43867 110355734
Hyperthyroidism 12.74 9.58 19 189679 29242 110370359
Femoral neck fracture 12.64 9.58 3 189695 12564 110387037
Condition aggravated 12.61 9.58 1087 188611 733749 109665852
Skin necrosis 12.59 9.58 11 189687 21501 110378100
Post-traumatic stress disorder 12.59 9.58 32 189666 6564 110393037
Analgesic therapy 12.53 9.58 34 189664 7250 110392351
Drug therapy 12.51 9.58 34 189664 7257 110392344
Dizziness 12.47 9.58 1374 188324 696819 109702782
Terminal insomnia 12.47 9.58 16 189682 1922 110397679
Orthostatic hypotension 12.33 9.58 65 189633 66184 110333417
Back injury 12.32 9.58 130 189568 47269 110352332
Bacterial infection 12.32 9.58 127 189571 45909 110353692
Hot flush 12.30 9.58 170 189528 65866 110333735
Nasal dryness 12.29 9.58 29 189669 5677 110393924
Blood pressure increased 12.19 9.58 551 189147 257822 110141779
Diverticulitis 12.19 9.58 143 189555 53379 110346222
Somnambulism 12.14 9.58 31 189667 6374 110393227
Fibromyalgia 12.14 9.58 213 189485 170696 110228905
Perioral dermatitis 12.14 9.58 10 189688 711 110398890
Peritoneal perforation 12.08 9.58 6 189692 175 110399426
Hypersomnia 12.05 9.58 86 189612 27975 110371626
Hirsutism 12.05 9.58 15 189683 1748 110397853
Carpal tunnel syndrome 11.96 9.58 73 189625 22537 110377064
Lymphocyte count decreased 11.91 9.58 54 189644 57189 110342412
Pulmonary hypertension 11.90 9.58 146 189552 55074 110344527
Penile erythema 11.89 9.58 6 189692 181 110399420
Device breakage 11.88 9.58 51 189647 13718 110385883
Pain in extremity 11.88 9.58 980 188718 486138 109913463
Respiratory tract irritation 11.82 9.58 10 189688 738 110398863
Lymphadenopathy 11.76 9.58 164 189534 63671 110335930
Infusion site haemorrhage 11.73 9.58 25 189673 4573 110395028
Vocal cord atrophy 11.73 9.58 3 189695 10 110399591
Blood cholesterol increased 11.67 9.58 235 189463 184550 110215051
Erysipelas 11.65 9.58 4 189694 13154 110386447
Thrombosis 11.64 9.58 256 189442 108406 110291195
Muscle spasms 11.60 9.58 586 189112 277571 110122030
Acute myocardial infarction 11.60 9.58 90 189608 83687 110315914
Limb operation 11.59 9.58 23 189675 4001 110395600
Appetite disorder 11.56 9.58 40 189658 9729 110389872
Excessive cerumen production 11.56 9.58 11 189687 947 110398654
Product distribution issue 11.52 9.58 24 189674 4322 110395279
Nervousness 11.50 9.58 105 189593 36746 110362855
Panic attack 11.46 9.58 87 189611 28853 110370748
Multiple drug therapy 11.46 9.58 35 189663 7979 110391622
Ageusia 11.40 9.58 65 189633 19580 110380021
Drug effective for unapproved indication 11.40 9.58 5 189693 14162 110385439
Intervertebral disc protrusion 11.38 9.58 84 189614 27614 110371987
Intentional self-injury 11.38 9.58 30 189668 37399 110362202
Dysarthria 11.35 9.58 91 189607 84030 110315571
Blood urea increased 11.34 9.58 52 189646 54905 110344696
Gangrene 11.32 9.58 7 189691 16334 110383267
Bronchial wall thickening 11.32 9.58 20 189678 3187 110396414
Product substitution issue 11.29 9.58 73 189625 22988 110376613
Fungal infection 11.24 9.58 135 189563 50671 110348930
Exposure to toxic agent 11.23 9.58 4 189694 12854 110386747
Gastrointestinal haemorrhage 11.22 9.58 208 189490 165310 110234291
Immunoglobulins increased 11.21 9.58 10 189688 792 110398809
Lupus vulgaris 11.21 9.58 26 189672 33857 110365744
Therapeutic response shortened 11.20 9.58 88 189610 29495 110370106
IPEX syndrome 11.11 9.58 3 189695 13 110399588
Hypermetropia 11.06 9.58 8 189690 469 110399132
Nodular vasculitis 11.04 9.58 5 189693 118 110399483
Hypercholesterolaemia 11.04 9.58 101 189597 90736 110308865
Attention deficit hyperactivity disorder 10.98 9.58 24 189674 4467 110395134
Nephrotic syndrome 10.94 9.58 5 189693 13826 110385775
Pneumonia aspiration 10.91 9.58 88 189610 81145 110318456
Colitis ulcerative 10.90 9.58 190 189508 77173 110322428
Nasal septum deviation 10.90 9.58 16 189682 2182 110397419
Cystic fibrosis respiratory infection suppression 10.88 9.58 8 189690 481 110399120
Reflux laryngitis 10.87 9.58 7 189691 339 110399262
Perinatal depression 10.87 9.58 8 189690 482 110399119
Cystitis interstitial 10.81 9.58 13 189685 1461 110398140
Injection site haemorrhage 10.77 9.58 95 189603 32933 110366668
Infusion site extravasation 10.75 9.58 44 189654 11590 110388011
Encephalitis 10.59 9.58 10 189688 18829 110380772
Viral myelitis 10.56 9.58 5 189693 131 110399470
Injection site discolouration 10.54 9.58 37 189661 9066 110390535
Porphyria acute 10.52 9.58 10 189688 18770 110380831
Blue toe syndrome 10.47 9.58 9 189689 679 110398922
Pemphigoid 10.46 9.58 11 189687 19696 110379905
Chronic left ventricular failure 10.46 9.58 12 189686 1284 110398317
Hydronephrosis 10.45 9.58 12 189686 20653 110378948
Depressive symptom 10.44 9.58 35 189663 8379 110391222
Acidosis 10.43 9.58 14 189684 22517 110377084
Red blood cell sedimentation rate increased 10.43 9.58 85 189613 78217 110321384
Pancreatitis relapsing 10.41 9.58 13 189685 1519 110398082
Renal tubular necrosis 10.39 9.58 23 189675 30452 110369149
Immune thrombocytopenia 10.39 9.58 14 189684 22480 110377121
Central obesity 10.36 9.58 15 189683 2021 110397580
Oral pain 10.35 9.58 104 189594 37340 110362261
Panniculitis 10.35 9.58 7 189691 15575 110384026
CFTR gene mutation 10.28 9.58 6 189692 243 110399358
Bronchial secretion retention 10.25 9.58 25 189673 4999 110394602
Smoke sensitivity 10.14 9.58 9 189689 708 110398893
Enuresis 10.14 9.58 22 189676 4074 110395527
Sinonasal obstruction 10.12 9.58 7 189691 382 110399219
Arthritis bacterial 10.09 9.58 3 189695 10817 110388784
Cholecystectomy 10.08 9.58 41 189657 10768 110388833
Adjustment disorder 10.06 9.58 3 189695 10792 110388809
Rash macular 10.01 9.58 106 189592 38580 110361021
Iron deficiency 9.99 9.58 60 189638 18416 110381185
Asphyxia 9.97 9.58 6 189692 14209 110385392
Injection site vesicles 9.93 9.58 23 189675 4448 110395153
Bronchial irritation 9.93 9.58 4 189694 70 110399531
Ventricular tachycardia 9.92 9.58 48 189650 49961 110349640
Nasal pruritus 9.86 9.58 10 189688 930 110398671
Immune reconstitution inflammatory syndrome 9.86 9.58 8 189690 16218 110383383
Atopy 9.85 9.58 11 189687 1143 110398458
White blood cell count decreased 9.82 9.58 309 189389 229081 110170520
Atrioventricular block complete 9.79 9.58 12 189686 20070 110379531
Asthmatic crisis 9.78 9.58 15 189683 2127 110397474
Retinitis 9.76 9.58 26 189672 32301 110367300
Klebsiella infection 9.71 9.58 12 189686 19997 110379604
Nasal septum ulceration 9.67 9.58 3 189695 23 110399578
Vulva cyst 9.67 9.58 3 189695 23 110399578
Schizophrenia 9.67 9.58 14 189684 21812 110377789
Lip swelling 9.67 9.58 131 189567 50536 110349065
Bradyphrenia 9.66 9.58 4 189694 11724 110387877
Vocal cord polyp 9.65 9.58 6 189692 273 110399328
Personality disorder 9.61 9.58 5 189693 12832 110386769

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D07AC17 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, potent (group III)
ATC R01AD08 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R01AD58 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R03AK06 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK11 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03BA05 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 D001993 Bronchodilator Agents
MeSH PA D003879 Dermatologic Agents
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D019141 Respiratory System Agents
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:49167 anti-asthmatic drug
CHEBI has role CHEBI:50113 androgen
CHEBI has role CHEBI:50857 anti-allergic agent
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35472 anti-inflammatory drug
CHEBI has role CHEBI:35523 bronchodilator agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:37962 adrenergic agent
CHEBI has role CHEBI:50177 dermatologic drug
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 →
R01AD Corticosteroids 12 drugs
beclometasone dipropionatebetamethasonebudesonideciclesonidedexamethasoneflunisolidefluticasone furoatehydrocortisonemometasone furoateprednisolonetixocortoltriamcinolone
R03AK Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics 13 drugs
beclometasone dipropionatebudesonidecromoglicic acidepinephrinefluticasone furoateformoterolindacaterolisoprenalinemometasone furoatereproterolsalbutamolsalmeterol show all 13 →
R03BA Glucocorticoids 8 drugs
beclometasone dipropionatebetamethasonebudesonideciclesonideflunisolidefluticasone furoatemometasone furoatetriamcinolone

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
Pulmonary emphysema indication 87433001
Pruritus ani indication 90446007
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
Bronchospasm Prevention with COPD indication
Chronic Non-Allergic Rhinitis indication
COPD Associated with Chronic Bronchitis 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
Measles contraindication 14189004 DOID:8622
Disease caused by parasite contraindication 17322007
Glaucoma contraindication 23986001 DOID:1686
Acute tuberculosis contraindication 25629007
Viral disease contraindication 34014006 DOID:934
Hypertensive disorder contraindication 38341003 DOID:10763
Hypokalemia contraindication 43339004
Conduction disorder of the heart contraindication 44808001
Hypercortisolism contraindication 47270006
Ketoacidosis contraindication 56051008
Osteoporosis contraindication 64859006 DOID:11476
Diabetes mellitus contraindication 73211009 DOID:9351
Hypopituitarism contraindication 74728003 DOID:9406
Candidiasis of mouth contraindication 79740000 DOID:14262
Perforation of nasal septum contraindication 80142000
Hyperglycemia contraindication 80394007 DOID:4195
Bacterial infectious disease contraindication 87628006
Operation on nose contraindication 88733004
Thyrotoxicosis contraindication 90739004 DOID:7997
Bilateral cataracts contraindication 95722004
Prolonged QT interval contraindication 111975006
Seizure disorder contraindication 128613002
Pulmonary tuberculosis contraindication 154283005 DOID:2957
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
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Atrophoderma contraindication 399979006
Peripheral vascular disease contraindication 400047006
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Congenital long QT syndrome contraindication 442917000
Exposure to varicella contraindication 444453009
Nasal Candidiasis contraindication
Untreated Fungal Infection contraindication
Uncontrolled Bacterial Infections contraindication
Nasal Septal Ulcers contraindication
Nasal Trauma contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.49 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.093MG/SPRAY XHANCE PARATEK PHARMS N209022 Sept. 18, 2017 RX SPRAY, METERED NASAL 12083270 April 4, 2031 METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO DIGIHALER TEVA PHARM N208799 July 12, 2019 DISCN POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO RESPICLICK TEVA PHARM N208799 Jan. 27, 2017 RX POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO DIGIHALER TEVA PHARM N208799 July 12, 2019 DISCN POWDER INHALATION 9415008 Oct. 6, 2034 TREATMENT OF ASTHMA
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO RESPICLICK TEVA PHARM N208799 Jan. 27, 2017 RX POWDER INHALATION 9415008 Oct. 6, 2034 TREATMENT OF ASTHMA
0.113MG/INH;EQ 0.014MG BASE/INH AIRDUO DIGIHALER TEVA PHARM N208799 July 12, 2019 DISCN POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.113MG/INH;EQ 0.014MG BASE/INH AIRDUO RESPICLICK TEVA PHARM N208799 Jan. 27, 2017 RX POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.232MG/INH;EQ 0.014MG BASE/INH AIRDUO DIGIHALER TEVA PHARM N208799 July 12, 2019 DISCN POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.232MG/INH;EQ 0.014MG BASE/INH AIRDUO RESPICLICK TEVA PHARM N208799 Jan. 27, 2017 RX POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.093MG/SPRAY XHANCE PARATEK PHARMS N209022 Sept. 18, 2017 RX SPRAY, METERED NASAL 11554229 Feb. 23, 2036 METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY
0.093MG/SPRAY XHANCE PARATEK PHARMS N209022 Sept. 18, 2017 RX SPRAY, METERED NASAL 12616806 Feb. 23, 2036 METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY TO TREAT CHRONIC RHINOSINUSITIS WITH NASAL POLYPS IN ADULTS
0.093MG/SPRAY XHANCE PARATEK PHARMS N209022 Sept. 18, 2017 RX SPRAY, METERED NASAL 12616806 Feb. 23, 2036 METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY TO TREAT CHRONIC RHINOSINUSITIS WITHOUT NASAL POLYPS IN ADULTS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.044MG/INH FLUTICASONE PROPIONATE GLENMARK SPECLT A219602 March 3, 2026 RX AEROSOL, METERED INHALATION Sept. 20, 2026 COMPETITIVE GENERIC THERAPY
0.093MG/SPRAY XHANCE PARATEK PHARMS N209022 Sept. 18, 2017 RX SPRAY, METERED NASAL March 15, 2027 TREATMENT OF CHRONIC RHINOSINUSITIS WITHOUT NASAL POLYPS (CRSSNP) IN ADULTS

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST EC50 10.74 WOMBAT-PK CHEMBL
Mineralocorticoid receptor Nuclear hormone receptor AGONIST EC50 6.83 IUPHAR
Progesterone receptor Nuclear hormone receptor AGONIST EC50 9.77 WOMBAT-PK
Cytosolic phospholipase A2 Enzyme WOMBAT-PK
Glucocorticoid receptor Transcription factor EC50 9.12 CHEMBL

External reference:

IDSource
4020180 VUID
N0000148122 NUI
D01708 KEGG_DRUG
4020180 VANDF
4020529 VANDF
C0117996 UMLSCUI
CHEBI:31441 CHEBI
CHEMBL1473 ChEMBL_ID
D000068298 MESH_DESCRIPTOR_UI
DB00588 DRUGBANK_ID
7080 IUPHAR_LIGAND_ID
O2GMZ0LF5W UNII
444036 PUBCHEM_CID
DB13867 DRUGBANK_ID
41126 RXNORM
4756 MMSL
51966 MMSL
81052 MMSL
d01296 MMSL
003593 NDDF
004952 NDDF
108632003 SNOMEDCT_US
396064000 SNOMEDCT_US
397192001 SNOMEDCT_US
C0082607 UMLSCUI
CHEMBL1201396 ChEMBL_ID
90566-53-3 SECONDARY_CAS_RN
5311101 PUBCHEM_CID
6699 IUPHAR_LIGAND_ID
5636 INN_ID
CUT2W21N7U UNII
CHEBI:5134 CHEBI
O2GMZ0LF5W INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DYMISTA HUMAN PRESCRIPTION DRUG LABEL 2 0037-0245 SPRAY, METERED 50 ug NASAL NDA 29 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0054-0326 POWDER 100 ug RESPIRATORY (INHALATION) ANDA 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0054-0327 POWDER 250 ug RESPIRATORY (INHALATION) ANDA 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0054-0328 POWDER 500 ug RESPIRATORY (INHALATION) ANDA 28 sections
Fluticasone Propionate HUMAN PRESCRIPTION DRUG LABEL 1 0054-3270 SPRAY, METERED 50 ug NASAL ANDA 25 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3607 POWDER, METERED 55 ug RESPIRATORY (INHALATION) NDA authorized generic 31 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3608 POWDER, METERED 113 ug RESPIRATORY (INHALATION) NDA authorized generic 31 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3609 POWDER, METERED 232 ug RESPIRATORY (INHALATION) NDA authorized generic 31 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-7516 POWDER 500 ug RESPIRATORY (INHALATION) ANDA 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-7517 POWDER 100 ug RESPIRATORY (INHALATION) ANDA 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-7518 POWDER 250 ug RESPIRATORY (INHALATION) ANDA 28 sections
Good Sense 24 hour allergy nasal HUMAN OTC DRUG LABEL 1 0113-0028 SPRAY, METERED 50 ug NASAL ANDA 17 sections
Good Sense 24 hour allergy nasal HUMAN OTC DRUG LABEL 1 0113-0285 SPRAY, METERED 50 ug NASAL ANDA 17 sections
FLONASEALLERGY RELIEF HUMAN OTC DRUG LABEL 1 0135-0576 SPRAY, METERED 50 ug NASAL NDA 17 sections
CHILDRENS FLONASEALLERGY RELIEF HUMAN OTC DRUG LABEL 1 0135-0582 SPRAY, METERED 50 ug NASAL NDA 16 sections
CHILDRENS FLONASEALLERGY RELIEF HUMAN OTC DRUG LABEL 1 0135-0582 SPRAY, METERED 50 ug NASAL NDA 16 sections
FLUTICASONE PROPIONATE HUMAN PRESCRIPTION DRUG LABEL 1 0168-0332 CREAM 0.50 mg TOPICAL ANDA 21 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0695 POWDER 100 ug RESPIRATORY (INHALATION) NDA 27 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0696 POWDER 250 ug RESPIRATORY (INHALATION) NDA 27 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0697 POWDER 500 ug RESPIRATORY (INHALATION) NDA 27 sections
ADVAIR HFA HUMAN PRESCRIPTION DRUG LABEL 2 0173-0715 AEROSOL, METERED 45 ug RESPIRATORY (INHALATION) NDA 28 sections
ADVAIR HFA HUMAN PRESCRIPTION DRUG LABEL 2 0173-0716 AEROSOL, METERED 115 ug RESPIRATORY (INHALATION) NDA 28 sections
ADVAIR HFA HUMAN PRESCRIPTION DRUG LABEL 2 0173-0717 AEROSOL, METERED 230 ug RESPIRATORY (INHALATION) NDA 28 sections
24 Hour Allergy Nasal HUMAN OTC DRUG LABEL 1 0363-0024 SPRAY, METERED 50 ug NASAL ANDA 17 sections
Fluticasone Propionate HUMAN OTC DRUG LABEL 1 0363-0652 SPRAY, METERED 50 ug NASAL ANDA 16 sections
Fluticasone Propionate HUMAN OTC DRUG LABEL 1 0363-0652 SPRAY, METERED 50 ug NASAL ANDA 16 sections
CHILDRENS ALLERGY RELIEF HUMAN OTC DRUG LABEL 1 0363-4023 SPRAY, METERED 50 ug NASAL ANDA 17 sections
Azelastine Hydrochloride and Fluticasone Propionate HUMAN PRESCRIPTION DRUG LABEL 2 0378-3458 SPRAY, METERED 50 ug NASAL NDA authorized generic 29 sections
Wixela Inhub HUMAN PRESCRIPTION DRUG LABEL 2 0378-9320 POWDER 100 ug RESPIRATORY (INHALATION) ANDA 30 sections
Wixela Inhub HUMAN PRESCRIPTION DRUG LABEL 2 0378-9321 POWDER 250 ug RESPIRATORY (INHALATION) ANDA 30 sections