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

Stem definitionDrug idCAS RN
steroids for topical use, acetal derivatives 419 51333-22-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • budesonide
  • barazone
  • budesomide
  • budeson
A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.
  • Molecular weight: 430.54
  • Formula: C25H34O6
  • CLOGP: 2.90
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 93.06
  • ALOGS: -3.97
  • ROTB: 4
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
9 mg O
1.50 mg SL
0.20 mg N
0.80 mg Inhal.aerosol
0.80 mg Inhal.powder
1.50 mg Inhal.solution

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.09 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.04 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 37 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 3.90 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 20 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.13 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.80 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.025 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.945 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 70.632 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 7.727 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 6.990 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 13.930 % High 1
herg hERG pIC50 4.467 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 17.219 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 119.399 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 6 % High 1
kinase-safety-class ACVR2B,BRAF,CAMK2D,CDK5,EIF2AK3,ERBB2,GRK2,ITK,NTRK2,PDK1,PDK2,PDK4,PRKDC 13
kinase-selectivity-class GRK2 1
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 4.055 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 8.750 High 1
mh-clint Mouse hepatocyte intrinsic clearance 46.345 High 1
mppb Mouse plasma protein binding (% unbound) 5.750 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 38.282 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 14.400 % High 1
rat-kpuu-brain Rat brain Kpuu 0.028 % High 1
rh-clint Rat hepatocyte intrinsic clearance 94.842 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 46.320 % High 1
rppb Rat plasma protein binding (% unbound) 7.680 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 112.980 uM High 1

Approvals:

DateAgencyCompanyOrphan
Feb. 14, 1994 FDA
June 18, 2019 PMDA AstraZeneca K.K.
Aug. 1, 2018 EMA Dr. Falk Pharma GmbH

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 2132.65 10.56 2244 140020 239916 90246267
Obstructive airways disorder 940.49 10.56 556 141708 25313 90460870
Full blood count abnormal 835.71 10.56 587 141677 36010 90450173
Dyspnoea 751.24 10.56 3045 139219 877910 89608273
Wheezing 677.38 10.56 1284 140980 236796 90249387
Cough 622.06 10.56 1613 140651 367349 90118834
Macular degeneration 517.81 10.56 449 141815 37521 90448662
Chest discomfort 473.26 10.56 809 141455 137556 90348627
Nasal polyps 462.50 10.56 259 142005 10621 90475562
Hand deformity 433.85 10.56 6 142258 296356 90189827
Chronic sinusitis 407.04 10.56 321 141943 23481 90462702
Glossodynia 396.92 10.56 28 142236 321751 90164432
Sleep disorder due to a general medical condition 394.69 10.56 416 141848 44322 90441861
Colitis ulcerative 388.20 10.56 476 141788 59790 90426393
Breath sounds abnormal 382.19 10.56 260 142004 15126 90471057
Systemic lupus erythematosus 378.66 10.56 58 142206 361838 90124345
Upper-airway cough syndrome 369.41 10.56 253 142011 14882 90471301
Rhinitis allergic 357.18 10.56 258 142006 16527 90469656
Pericarditis 356.22 10.56 16 142248 270135 90216048
Helicobacter infection 339.21 10.56 3 142261 226847 90259336
Eosinophil count increased 320.04 10.56 219 142045 12862 90473321
Eosinophilia 280.01 10.56 281 141983 28252 90457931
Loss of personal independence in daily activities 279.76 10.56 643 141621 135462 90350721
Haematochezia 279.19 10.56 442 141822 70471 90415712
Therapeutic product effect incomplete 278.33 10.56 800 141464 193096 90293087
Wound 275.92 10.56 68 142196 302912 90183271
Nasal congestion 273.61 10.56 479 141785 82935 90403248
Folliculitis 269.69 10.56 12 142252 204341 90281842
Chronic obstructive pulmonary disease 267.29 10.56 443 141821 73386 90412797
Pulmonary function test abnormal 267.28 10.56 115 142149 2624 90483559
Frequent bowel movements 262.57 10.56 382 141882 56553 90429630
Swelling 261.35 10.56 168 142096 418890 90067293
Contraindicated product administered 256.63 10.56 91 142173 320048 90166135
Bronchial secretion retention 254.96 10.56 121 142143 3494 90482689
Blood test abnormal 248.42 10.56 229 142035 20723 90465460
Productive cough 246.89 10.56 438 141826 76625 90409558
Impaired healing 246.06 10.56 37 142227 234162 90252021
Sputum discoloured 245.91 10.56 225 142039 20166 90466017
Psoriatic arthropathy 244.72 10.56 34 142230 228301 90257882
Eosinophilic bronchitis 236.28 10.56 72 142192 571 90485612
Alopecia 231.21 10.56 262 142002 494809 89991374
Bronchiectasis 228.51 10.56 225 142039 22105 90464078
Female genital tract fistula 217.11 10.56 198 142066 17670 90468513
Arthropathy 213.45 10.56 158 142106 366084 90120099
Synovitis 207.15 10.56 131 142133 329621 90156562
Liver injury 206.89 10.56 16 142248 170551 90315632
Chest X-ray abnormal 202.55 10.56 116 142148 4966 90481217
Blood cholesterol increased 200.74 10.56 41 142223 207971 90278212
Stomatitis 194.42 10.56 94 142170 274604 90211579
Abdominal discomfort 193.46 10.56 281 141983 477047 90009136
Blister 193.45 10.56 79 142185 254919 90231264
Ear pruritus 190.77 10.56 124 142140 6679 90479504
Impaired quality of life 187.89 10.56 206 142058 22938 90463245
Toxicity to various agents 186.84 10.56 110 142154 287736 90198447
Gastrooesophageal reflux disease 182.96 10.56 626 141638 165711 90320472
Irritable bowel syndrome 178.51 10.56 52 142212 207396 90278787
Rhinorrhoea 174.55 10.56 411 141853 87905 90398278
Polycystic ovaries 168.29 10.56 107 142157 5547 90480636
Sleep apnoea syndrome 167.13 10.56 227 142037 31520 90454663
Mobility decreased 165.30 10.56 94 142170 250640 90235543
Bronchospasm 164.09 10.56 182 142082 20527 90465656
Reversible airways obstruction 163.60 10.56 74 142190 1909 90484274
Abdominal pain 161.66 10.56 1119 141145 394602 90091581
Blood immunoglobulin E increased 160.46 10.56 95 142169 4330 90481853
Paraesthesia oral 160.08 10.56 222 142042 31437 90454746
Joint swelling 159.90 10.56 345 141919 502955 89983228
Pneumonia 159 10.56 1614 140650 636445 89849738
Completed suicide 156.80 10.56 21 142243 145037 90341146
Vaginal flatulence 153.45 10.56 140 142124 12498 90473685
Respiratory symptom 153.44 10.56 91 142173 4161 90482022
Joint range of motion decreased 148.14 10.56 19 142245 135624 90350559
Proctitis 145.53 10.56 148 142116 15111 90471072
Injury 145.07 10.56 64 142200 197285 90288898
Therapeutic reaction time decreased 144.46 10.56 83 142181 3575 90482608
Vital capacity decreased 144.14 10.56 66 142198 1753 90484430
Middle insomnia 141.04 10.56 152 142112 16599 90469584
Heart rate increased 140.32 10.56 443 141821 112459 90373724
Sensitisation 139.40 10.56 85 142179 4090 90482093
Colitis 137.66 10.56 325 141939 69617 90416566
Blood lactic acid increased 136.49 10.56 112 142152 8666 90477517
Discomfort 135.89 10.56 138 142126 274197 90211986
Procedural pain 135.50 10.56 211 142053 33149 90453034
Confusional state 133.47 10.56 252 142012 385953 90100230
Lip dry 132.91 10.56 6 142258 100949 90385234
Bronchopulmonary aspergillosis allergic 131.74 10.56 79 142185 3687 90482496
Bursitis 131.11 10.56 24 142240 131630 90354553
Asthmatic crisis 125.79 10.56 61 142203 1849 90484334
Sputum culture positive 124.88 10.56 64 142200 2189 90483994
Polyp 124.06 10.56 100 142164 7544 90478639
Radiculopathy 123.71 10.56 149 142115 18356 90467827
Ileal stenosis 121.94 10.56 65 142199 2413 90483770
Treatment failure 119.04 10.56 183 142081 303745 90182438
Forced expiratory volume decreased 118.39 10.56 87 142177 5721 90480462
Bacterial disease carrier 118.11 10.56 58 142206 1808 90484375
Ejection fraction 118.05 10.56 68 142196 2943 90483240
Pulmonary mass 115.49 10.56 181 142083 28591 90457592
Hepatic enzyme increased 113.87 10.56 248 142016 360488 90125695
Superinfection 113.34 10.56 67 142197 3045 90483138
Oral candidiasis 111.56 10.56 200 142064 35255 90450928
Vaginal discharge 111.40 10.56 145 142119 19319 90466864
Sinusitis fungal 109.46 10.56 56 142208 1908 90484275
Hypercholesterolaemia 108.09 10.56 15 142249 100877 90385306
C-reactive protein abnormal 107.67 10.56 33 142231 127396 90358787
Neutropenia 107.02 10.56 117 142147 224787 90261396
Total lung capacity decreased 105.99 10.56 69 142195 3726 90482457
Sleep disorder due to general medical condition, insomnia type 105.76 10.56 35 142229 128659 90357524
Dyspnoea exertional 105.26 10.56 300 141964 71988 90414195
Peripheral venous disease 104.25 10.56 7 142257 83914 90402269
Weight decreased 103.65 10.56 980 141284 378930 90107253
Lacrimation increased 101.42 10.56 165 142099 26897 90459286
Respiratory tract infection 100.87 10.56 260 142004 58818 90427365
Febrile neutropenia 100.60 10.56 62 142202 158287 90327896
Rales 100.23 10.56 124 142140 15703 90470480
Growth failure 99.28 10.56 33 142231 356 90485827
Thrombocytopenia 97.75 10.56 110 142154 208615 90277568
Lung diffusion test abnormal 96.92 10.56 31 142233 293 90485890
Prescribed overdose 96.76 10.56 18 142246 97607 90388576
Sneezing 95.91 10.56 170 142094 29699 90456484
Maternal exposure during pregnancy 93.84 10.56 273 141991 359790 90126393
Defaecation urgency 93.63 10.56 78 142186 6164 90480019
Eosinophilic granulomatosis with polyangiitis 93.53 10.56 55 142209 2475 90483708
Hip arthroplasty 92.80 10.56 7 142257 76201 90409982
Wound infection 92.73 10.56 26 142238 106376 90379807
Neutrophilia 92.52 10.56 75 142189 5703 90480480
Rheumatoid arthritis 92.29 10.56 278 141986 362336 90123847
Off label use 91.65 10.56 2319 139945 1099933 89386250
Labile blood pressure 90.90 10.56 49 142215 1861 90484322
Blood pressure increased 89.60 10.56 573 141691 196644 90289539
Intentional overdose 89.44 10.56 19 142245 93815 90392368
Lung opacity 88.94 10.56 75 142189 6027 90480156
Faecal calprotectin increased 86.45 10.56 62 142202 3925 90482258
Sciatica 86.10 10.56 26 142238 101356 90384827
White blood cell count decreased 85.08 10.56 82 142182 167027 90319156
Night sweats 83.78 10.56 49 142215 128717 90357466
Throat clearing 81.53 10.56 59 142205 3788 90482395
Sputum increased 80.72 10.56 53 142211 2904 90483279
Hypothyroidism 79.80 10.56 223 142041 52904 90433279
Sinus disorder 78.85 10.56 170 142094 34277 90451906
Drug intolerance 78.16 10.56 399 141865 447192 90038991
Peripheral swelling 78.09 10.56 358 141906 412748 90073435
Rectal haemorrhage 76.97 10.56 295 141969 82449 90403734
Road traffic accident 75.82 10.56 37 142227 107589 90378594
Ill-defined disorder 75.59 10.56 108 142156 184783 90301400
Decreased appetite 74.98 10.56 320 141944 376220 90109963
Colitis microscopic 74.83 10.56 90 142174 11069 90475114
Obesity 73.22 10.56 37 142227 105470 90380713
Nail disorder 73.15 10.56 5 142259 59062 90427121
Therapeutic product effect decreased 72.62 10.56 210 142054 277361 90208822
Inappropriate schedule of product administration 72.06 10.56 442 141822 149491 90336692
Eye pruritus 71.96 10.56 148 142116 28879 90457304
Multiple allergies 71.80 10.56 103 142161 15043 90471140
Haemoptysis 71.24 10.56 160 142104 33160 90453023
Drug specific antibody present 70.72 10.56 63 142201 5451 90480732
Bone erosion 70.28 10.56 3 142261 53018 90433165
Steroid dependence 70.18 10.56 44 142220 2225 90483958
Drug abuse 70.14 10.56 21 142243 82326 90403857
Infection 70.09 10.56 311 141953 361783 90124400
Hyper IgE syndrome 69.05 10.56 27 142237 478 90485705
Musculoskeletal pain 69.05 10.56 101 142163 171150 90315033
Malignant neoplasm progression 69.05 10.56 41 142223 106829 90379354
Rheumatoid factor positive 68.46 10.56 102 142162 171548 90314635
Palpitations 67.56 10.56 406 141858 136322 90349861
Illness 67.24 10.56 281 141983 81688 90404495
Salpingo-oophorectomy unilateral 67.04 10.56 32 142232 936 90485247
Rash 66.96 10.56 865 141399 795235 89690948
Platelet count increased 66.04 10.56 118 142146 20741 90465442
Emphysema 65.62 10.56 88 142176 12067 90474116
Dysphonia 65.46 10.56 233 142031 62851 90423332
Liver disorder 64.69 10.56 57 142207 121212 90364971
Drug level below therapeutic 64.02 10.56 61 142203 5753 90480430
Intestinal obstruction 62.95 10.56 163 142101 36968 90449215
Death 62.29 10.56 440 141824 456111 90030072
Intestinal stenosis 62.17 10.56 47 142217 3227 90482956
Oropharyngeal pain 62.08 10.56 350 141914 114837 90371346
Graft versus host disease in gastrointestinal tract 62.04 10.56 53 142211 4335 90481848
Ejection fraction abnormal 61.63 10.56 42 142222 2449 90483734
Drug ineffective 60.94 10.56 2703 139561 1381595 89104588
Aspiration 60.60 10.56 97 142167 15596 90470587
Embolism venous 60.11 10.56 48 142216 3572 90482611
Fibromyalgia 60.03 10.56 148 142116 206121 90280062
Blepharospasm 59.96 10.56 8 142256 55437 90430746
Onychomadesis 59.68 10.56 3 142261 45995 90440188
Vocal cord dysfunction 59.62 10.56 29 142235 885 90485298
Delirium 59.44 10.56 46 142218 104313 90381870
Cardiac murmur 58.99 10.56 104 142160 18090 90468093
Lower limb fracture 58.71 10.56 30 142234 84983 90401200
Ileal ulcer 58.27 10.56 30 142234 1036 90485147
Eczema 58.08 10.56 199 142065 52671 90433512
Tremor 57.65 10.56 425 141839 152748 90333435
Carpal tunnel syndrome 56.97 10.56 120 142144 23808 90462375
Vasculitis 56.60 10.56 116 142148 22577 90463606
Drug level decreased 56.48 10.56 73 142191 9657 90476526
Bronchitis 56.24 10.56 422 141842 152505 90333678
Blood calcium increased 55.70 10.56 81 142183 11977 90474206
Granuloma skin 55.65 10.56 76 142188 10604 90475579
Knee arthroplasty 55.03 10.56 31 142233 83151 90403032
Pulmonary function test decreased 54.98 10.56 50 142214 4444 90481739
Ulcer 54.36 10.56 143 142121 32739 90453444
Upper respiratory fungal infection 54.25 10.56 18 142246 193 90485990
Taste disorder 53.70 10.56 15 142249 61531 90424652
Blood parathyroid hormone decreased 53.46 10.56 80 142184 12136 90474047
Acute kidney injury 53.42 10.56 290 141974 320097 90166086
Bronchial obstruction 52.86 10.56 33 142231 1656 90484527
Rhinitis 52.56 10.56 84 142180 13488 90472695
Sinus operation 52.55 10.56 41 142223 2950 90483233
Catarrh 51.33 10.56 32 142232 1602 90484581
Gait inability 51.01 10.56 95 142169 146361 90339822
Ventricular failure 50.54 10.56 20 142244 366 90485817
Nephrectomy 50.44 10.56 34 142230 1947 90484236
Secretion discharge 50.42 10.56 90 142174 15806 90470377
Erythema 50.34 10.56 566 141698 228680 90257503
Platelet count decreased 50.26 10.56 86 142178 136883 90349300
Peak expiratory flow rate decreased 49.95 10.56 23 142241 619 90485564
Hypoaesthesia 49.89 10.56 289 141975 313921 90172262
Epilepsy 49.73 10.56 34 142230 82172 90404011
Laryngeal stenosis 49.21 10.56 29 142235 1310 90484873
Anal fissure 49.12 10.56 51 142213 5334 90480849
Live birth 48.82 10.56 32 142232 79075 90407108
Gastrointestinal disorder 48.72 10.56 222 142042 256465 90229718
Nasal obstruction 48.50 10.56 37 142227 2575 90483608
Total lung capacity increased 48.42 10.56 49 142215 4972 90481211
Memory impairment 48.16 10.56 154 142110 197090 90289093
Hypersensitivity 47.59 10.56 470 141794 454207 90031976
Mucous stools 46.44 10.56 49 142215 5222 90480961
Eosinophilic oesophagitis 46.40 10.56 24 142240 837 90485346
Bacterial infection 46.17 10.56 109 142155 23335 90462848
Pain 46.03 10.56 1202 141062 995139 89491044
Foot deformity 45.97 10.56 18 142246 59633 90426550
Anaphylactic reaction 45.87 10.56 264 142000 87260 90398923
Adrenal suppression 45.56 10.56 25 142239 984 90485199
Hepatic ischaemia 45.55 10.56 23 142241 762 90485421
Oedema 45.07 10.56 162 142102 200133 90286050
Panniculitis 44.76 10.56 81 142183 14377 90471806
Exostosis 44.44 10.56 14 142250 53120 90433063
Atelectasis 44.34 10.56 110 142154 24299 90461884
Blood potassium decreased 44.25 10.56 170 142094 47557 90438626
Onychomycosis 43.94 10.56 4 142260 37372 90448811
Anosmia 43.82 10.56 65 142199 9783 90476400
Gastrointestinal wall thickening 43.53 10.56 32 142232 2105 90484078
Intentional device misuse 43.32 10.56 23 142241 847 90485336
Back injury 43.30 10.56 10 142254 46612 90439571
Systemic mycosis 43.17 10.56 28 142236 1502 90484681
Scoliosis 42.85 10.56 61 142203 8846 90477337
Disease progression 42.78 10.56 116 142148 156499 90329684
Skin necrosis 42.72 10.56 87 142177 16854 90469329
Arthritis enteropathic 42.56 10.56 18 142246 393 90485790
Asthma-chronic obstructive pulmonary disease overlap syndrome 42.20 10.56 45 142219 4854 90481329
Dry mouth 41.99 10.56 148 142116 183911 90302272
Aspergillus infection 41.93 10.56 67 142197 10756 90475427
Graft versus host disease in skin 41.62 10.56 40 142224 3813 90482370
Endometriosis 41.26 10.56 50 142214 6198 90479985
Aphonia 40.69 10.56 71 142193 12248 90473935
Restrictive pulmonary disease 40.68 10.56 32 142232 2330 90483853
Faeces soft 39.97 10.56 54 142210 7457 90478726
Autoimmune disorder 39.82 10.56 37 142227 76707 90409476
Stoma closure 39.21 10.56 14 142250 190 90485993
Sinus pain 38.68 10.56 45 142219 5344 90480839
Throat irritation 38.43 10.56 165 142099 48530 90437653
Hepatorenal syndrome 38.00 10.56 29 142235 2019 90484164
Type 2 diabetes mellitus 37.83 10.56 177 142087 203067 90283116
Cardiac disorder 37.66 10.56 183 142081 56689 90429494
Infective pulmonary exacerbation of cystic fibrosis 37.60 10.56 62 142202 10217 90475966
Myalgia 37.36 10.56 430 141834 174695 90311488
Condition aggravated 37.28 10.56 1210 141054 594335 89891848
Leukopenia 37.16 10.56 63 142201 100647 90385536
Cushingoid 37.09 10.56 62 142202 10333 90475850
Ileectomy 36.96 10.56 15 142249 294 90485889
Pancytopenia 36.80 10.56 84 142180 120179 90366004
Infusion related reaction 36.74 10.56 448 141816 416332 90069851
Circumstance or information capable of leading to medication error 36.53 10.56 42 142222 4925 90481258
Neutrophil count decreased 36.51 10.56 35 142229 71497 90414686
Venous pressure jugular increased 36.05 10.56 18 142246 582 90485601
Clostridium difficile infection 36.01 10.56 132 142132 36113 90450070
Dust allergy 35.95 10.56 20 142244 809 90485374
Hepatic cirrhosis 35.87 10.56 28 142236 63225 90422958
Bulimia nervosa 35.62 10.56 17 142247 497 90485686
Device expulsion 35.60 10.56 10 142254 40876 90445307
Terminal ileitis 35.58 10.56 23 142241 1227 90484956
Faecal calprotectin abnormal 35.53 10.56 13 142251 190 90485993
Cystic fibrosis 35.37 10.56 37 142227 3904 90482279
Overdose 35.18 10.56 128 142136 157581 90328602
Coeliac disease 35.15 10.56 13 142251 44597 90441586
Hypotension 35.01 10.56 334 141930 325063 90161120
Bowel movement irregularity 34.92 10.56 47 142217 6467 90479716
Asphyxia 34.69 10.56 49 142215 7054 90479129
Musculoskeletal stiffness 34.68 10.56 298 141966 296234 90189949
General physical health deterioration 34.30 10.56 374 141890 354741 90131442
Vomiting 34.25 10.56 959 141305 787334 89698849
Rhonchi 34.23 10.56 32 142232 2946 90483237
Butterfly rash 34.22 10.56 28 142236 2157 90484026
Viral infection 33.97 10.56 142 142122 41272 90444911
Upper respiratory tract infection 33.90 10.56 329 141935 127989 90358194
Nonspecific reaction 33.87 10.56 31 142233 2778 90483405
Muscle relaxant therapy 33.73 10.56 12 142252 161 90486022
Cytomegalovirus infection 33.59 10.56 105 142159 26497 90459686
Neoplasm progression 33.34 10.56 14 142250 44472 90441711
Underdose 33.13 10.56 22 142242 53995 90432188
Diabetes mellitus 32.90 10.56 194 142070 64681 90421502
Suicide attempt 32.86 10.56 42 142222 75357 90410826
Respiratory tract inflammation 32.60 10.56 17 142247 603 90485580
Increased bronchial secretion 32.49 10.56 27 142237 2126 90484057
Stress 32.43 10.56 229 142035 81166 90405017
Sarcoidosis 32.04 10.56 59 142205 10614 90475569
Joint dislocation 31.89 10.56 15 142249 44567 90441616
Tachypnoea 31.56 10.56 89 142175 21220 90464963
Drug specific antibody 30.83 10.56 28 142236 2484 90483699
Retinitis viral 30.82 10.56 13 142251 282 90485901
Malignant mediastinal neoplasm 30.77 10.56 22 142242 1386 90484797
Diastolic dysfunction 30.64 10.56 47 142217 7286 90478897
Bronchomalacia 30.46 10.56 12 142252 217 90485966
Sedation 30.38 10.56 19 142245 48152 90438031
Muscular weakness 30.21 10.56 195 142069 206471 90279712
Hiatus hernia 30.11 10.56 98 142166 25263 90460920
Abdominal pain lower 30.06 10.56 110 142154 30067 90456116
Sleep disorder 29.90 10.56 185 142079 197845 90288338
Multiple sclerosis relapse 29.85 10.56 23 142241 52282 90433901
Lupus-like syndrome 29.81 10.56 20 142244 48826 90437357
Graft versus host disease 29.63 10.56 49 142215 8095 90478088
Paraesthesia 29.52 10.56 251 142013 250075 90236108
Frustration tolerance decreased 29.39 10.56 48 142216 7848 90478335
Fall 29.38 10.56 556 141708 481254 90004929
Anal fistula 29.35 10.56 35 142229 4266 90481917
Sputum culture 29.26 10.56 13 142251 321 90485862
Myelosuppression 28.80 10.56 25 142239 53566 90432617
Oropharyngeal discomfort 28.76 10.56 47 142217 7688 90478495
Exposure to allergen 28.69 10.56 15 142249 535 90485648
Bronchial wall thickening 28.63 10.56 25 142239 2106 90484077
Loss of therapeutic response 28.60 10.56 23 142241 1729 90484454
Walking aid user 28.56 10.56 10 142254 35496 90450687
Pouchitis 28.45 10.56 16 142248 661 90485522
Hypogammaglobulinaemia 28.33 10.56 56 142208 10618 90475565
Social problem 28.27 10.56 20 142244 1239 90484944
Herpes simplex oesophagitis 28.12 10.56 11 142253 195 90485988
Pulmonary artery stenosis congenital 28.09 10.56 14 142250 451 90485732
Dolichocolon 28.04 10.56 8 142256 49 90486134
Diverticulum 27.97 10.56 60 142204 12053 90474130
Bone marrow failure 27.83 10.56 8 142256 32213 90453970
Nasal discharge discolouration 27.80 10.56 28 142236 2825 90483358
Rheumatoid nodule 27.71 10.56 82 142182 20084 90466099
Abdominal pain upper 27.66 10.56 362 141902 332312 90153871
Abscess 27.10 10.56 78 142186 18813 90467370
Skin lesion 26.75 10.56 123 142141 37242 90448941
Status asthmaticus 26.72 10.56 17 142247 882 90485301
Aggression 26.39 10.56 97 142167 26571 90459612
Hypoxia 26.15 10.56 199 142065 72200 90413983
Injection site reaction 26.05 10.56 67 142197 92013 90394170
Intentional self-injury 25.87 10.56 7 142257 29327 90456856
Ileocaecal resection 25.82 10.56 14 142250 538 90485645
Sprue-like enteropathy 25.81 10.56 17 142247 936 90485247
Erythema nodosum 25.78 10.56 38 142226 5686 90480497
Pain in extremity 25.32 10.56 527 141737 450002 90036181
Infective exacerbation of chronic obstructive airways disease 25.31 10.56 20 142244 1466 90484717
Obstruction 25.28 10.56 31 142233 3890 90482293
Large intestinal stenosis 25.24 10.56 25 142239 2472 90483711
Eosinophil count decreased 25.05 10.56 28 142236 3184 90482999
Psoriasis 25.01 10.56 133 142131 147621 90338562
Red blood cell sedimentation rate abnormal 24.99 10.56 4 142260 24200 90461983
Hyperglycaemia 24.93 10.56 151 142113 50819 90435364
Maternal exposure timing unspecified 24.90 10.56 3 142261 22480 90463703
Contusion 24.87 10.56 263 142001 250953 90235230
Cardio-respiratory arrest 24.70 10.56 38 142226 63102 90423081
COVID-19 24.59 10.56 387 141877 168456 90317727
Malaise 24.42 10.56 1139 141125 584847 89901336
Burning sensation 24.39 10.56 177 142087 63275 90422908
Device delivery system issue 24.17 10.56 21 142243 1757 90484426
Burns second degree 24.16 10.56 22 142242 1958 90484225
Device malfunction 23.95 10.56 80 142184 20897 90465286
Haemorrhagic diathesis 23.92 10.56 36 142228 5488 90480695
Pulmonary embolism 23.89 10.56 312 141952 130508 90355675
Product use issue 23.89 10.56 369 141895 329550 90156633
Respiration abnormal 23.88 10.56 44 142220 7919 90478264
Cytomegalovirus colitis 23.84 10.56 28 142236 3358 90482825
Renal disorder 23.77 10.56 120 142144 37739 90448444
Headache 23.69 10.56 1614 140650 861132 89625051
Ageusia 23.66 10.56 67 142197 16009 90470174
Finger deformity 23.64 10.56 11 142253 32886 90453297
Osteoarthritis 23.63 10.56 195 142069 195535 90290648
Gastrointestinal polyp 23.52 10.56 9 142255 150 90486033
Metastases to liver 23.37 10.56 8 142256 28799 90457384
Pleuritic pain 23.22 10.56 51 142213 10410 90475773
Fatigue 23.22 10.56 1531 140733 1152492 89333691
Acquired diaphragmatic eventration 22.94 10.56 13 142251 545 90485638
Hepatic cytolysis 22.74 10.56 10 142254 30906 90455277
Oligoarthritis 22.73 10.56 13 142251 555 90485628
Cervix carcinoma stage 0 22.50 10.56 13 142251 566 90485617
Skin neoplasm excision 22.49 10.56 20 142244 1726 90484457
Sinus congestion 22.47 10.56 94 142170 27330 90458853
Immunodeficiency 22.24 10.56 21 142243 43213 90442970
Constipation 22.23 10.56 587 141677 279808 90206375
Depressed level of consciousness 22.13 10.56 51 142213 72733 90413450
Terminal insomnia 22.10 10.56 17 142247 1198 90484985
Coma 22.00 10.56 51 142213 72581 90413602
Ulcer haemorrhage 21.89 10.56 7 142257 26314 90459869
Toxic epidermal necrolysis 21.69 10.56 12 142252 32516 90453667
Epstein-Barr virus infection reactivation 21.58 10.56 19 142245 1618 90484565
Crohn's disease 21.56 10.56 32 142232 4819 90481364
Intestinal anastomosis 21.52 10.56 15 142249 907 90485276
Ascites 21.43 10.56 26 142238 47714 90438469
Inflammatory bowel disease 21.40 10.56 33 142231 5138 90481045
Disease recurrence 21.33 10.56 116 142148 37537 90448646
Amnesia 21.07 10.56 93 142171 108412 90377771
Throat tightness 21.07 10.56 97 142167 29387 90456796
Viral haemorrhagic cystitis 21.04 10.56 18 142246 1475 90484708
Lip infection 21.03 10.56 8 142256 131 90486052
Respiratory syncytial virus infection 20.94 10.56 49 142215 10431 90475752
Paranasal sinus discomfort 20.78 10.56 36 142228 6174 90480009
Gastroenteritis adenovirus 20.75 10.56 10 142254 299 90485884
Seasonal allergy 20.60 10.56 81 142183 22902 90463281
Sputum purulent 20.50 10.56 17 142247 1335 90484848
Cholelithiasis 20.49 10.56 147 142117 52359 90433824
Rectal tenesmus 20.45 10.56 16 142248 1156 90485027
Ligament pain 20.42 10.56 9 142255 218 90485965
Sensitivity to weather change 20.41 10.56 44 142220 8870 90477313
Kyphosis 20.40 10.56 24 142240 2884 90483299
Diarrhoea haemorrhagic 20.37 10.56 49 142215 10614 90475569
Incorrect dose administered 20.17 10.56 201 142063 78729 90407454
White coat hypertension 20.10 10.56 15 142249 1010 90485173
Respiratory distress 20.09 10.56 117 142147 38829 90447354
Candida infection 20.03 10.56 106 142158 33951 90452232
Oedema peripheral 19.88 10.56 538 141726 257377 90228806
Intestinal fistula 19.81 10.56 15 142249 1032 90485151
Body temperature decreased 19.80 10.56 82 142182 23734 90462449
Electrocardiogram QT prolonged 19.53 10.56 54 142210 72402 90413781
Anal incontinence 19.52 10.56 63 142201 16167 90470016
Metabolic acidosis 19.48 10.56 36 142228 55640 90430543
Increased upper airway secretion 19.40 10.56 27 142237 3834 90482349
Aural polyp 19.38 10.56 8 142256 164 90486019
Neurotoxicity 19.16 10.56 5 142259 21462 90464721
Metastases to bone 19.16 10.56 8 142256 25497 90460686
Cytokine release syndrome 19.12 10.56 10 142254 27963 90458220
Pseudomonas infection 19.07 10.56 59 142205 14806 90471377
Mitochondrial neurogastrointestinal encephalopathy 19.07 10.56 4 142260 4 90486179
Device dislocation 19.06 10.56 13 142251 31469 90454714
Type IV hypersensitivity reaction 19.05 10.56 27 142237 3899 90482284
Osteomyelitis 18.97 10.56 10 142254 27836 90458347
Abnormal faeces 18.89 10.56 36 142228 6646 90479537
Human herpesvirus 6 infection 18.76 10.56 25 142239 3407 90482776
Smoke sensitivity 18.71 10.56 11 142253 495 90485688
Drug eruption 18.68 10.56 107 142157 35300 90450883
Fluid retention 18.66 10.56 73 142191 88018 90398165
Intestinal resection 18.64 10.56 23 142241 2904 90483279
Pharyngeal hypoaesthesia 18.47 10.56 10 142254 383 90485800
Cytomegalovirus duodenitis 18.46 10.56 6 142258 60 90486123
Periorbital oedema 18.45 10.56 36 142228 6763 90479420
Distal intestinal obstruction syndrome 18.37 10.56 11 142253 512 90485671
Adverse reaction 18.35 10.56 12 142252 29700 90456483
Adrenal insufficiency 18.20 10.56 94 142170 29827 90456356
Small intestinal resection 18.14 10.56 12 142252 666 90485517
Short-bowel syndrome 18.14 10.56 12 142252 666 90485517
Skin exfoliation 18.01 10.56 51 142213 67862 90418321
Anastomotic stenosis 17.81 10.56 10 142254 412 90485771
Cryptosporidiosis infection 17.72 10.56 10 142254 416 90485767
Basal cell carcinoma 17.67 10.56 101 142163 33288 90452895
Dyspnoea at rest 17.66 10.56 29 142235 4762 90481421
Creatinine renal clearance decreased 17.65 10.56 4 142260 18895 90467288
Joint stiffness 17.62 10.56 63 142201 77979 90408204
Allergy to animal 17.54 10.56 17 142247 1637 90484546
Plasma cell myeloma 17.53 10.56 23 142241 40805 90445378
Pneumococcal infection 17.53 10.56 15 142249 1230 90484953
Small intestinal stenosis 17.42 10.56 12 142252 712 90485471
Serum ferritin decreased 17.39 10.56 21 142243 2593 90483590
Tracheal disorder 17.32 10.56 9 142255 317 90485866
Lung adenocarcinoma stage IV 17.21 10.56 10 142254 440 90485743
Aphthous ulcer 17.20 10.56 63 142201 17224 90468959
Congenital hypoplasia of depressor angularis oris muscle 17.18 10.56 6 142258 76 90486107
Infrapatellar fat pad inflammation 17.11 10.56 8 142256 223 90485960
Hyperkalaemia 17.07 10.56 49 142215 64915 90421268
Pharyngeal oedema 17.06 10.56 54 142210 13717 90472466
Swollen tongue 16.98 10.56 127 142137 45829 90440354
Poor venous access 16.84 10.56 68 142196 19459 90466724
Posterior reversible encephalopathy syndrome 16.79 10.56 7 142257 22332 90463851
Cholangitis sclerosing 16.70 10.56 19 142245 2202 90483981
Myelodysplastic syndrome 16.62 10.56 6 142258 20897 90465286
Drug-induced liver injury 16.59 10.56 79 142185 90239 90395944
Hypopnoea 16.58 10.56 27 142237 4404 90481779
Swelling face 16.56 10.56 198 142066 81154 90405029
Female reproductive neoplasm 16.48 10.56 5 142259 39 90486144
Rectal prolapse 16.39 10.56 19 142245 2248 90483935
Neuromuscular scoliosis 16.38 10.56 3 142261 0 90486183
Foreign body in mouth 16.38 10.56 3 142261 0 90486183
Cognitive disorder 16.37 10.56 55 142209 69352 90416831
Product dose omission issue 16.27 10.56 585 141679 291102 90195081
Red blood cell count decreased 16.19 10.56 30 142234 46321 90439862
Medication error 16.17 10.56 73 142191 84579 90401604
Enteritis 16.16 10.56 44 142220 10277 90475906
Infusion site extravasation 16.15 10.56 44 142220 10284 90475899
Post viral fatigue syndrome 16.13 10.56 8 142256 255 90485928
Alternaria infection 16.11 10.56 9 142255 367 90485816
Hypomania 16.06 10.56 40 142224 8857 90477326
Oesophageal candidiasis 15.97 10.56 34 142230 6795 90479388
Eczema impetiginous 15.84 10.56 4 142260 14 90486169
Fungal infection 15.82 10.56 118 142146 42543 90443640
Hysterectomy 15.82 10.56 47 142217 11537 90474646
Herpes simplex colitis 15.79 10.56 6 142258 98 90486085
Vaccination site pain 15.78 10.56 9 142255 382 90485801
Hyponatraemia 15.68 10.56 134 142130 133404 90352779
Nocturnal dyspnoea 15.65 10.56 15 142249 1425 90484758
Haemoglobin decreased 15.44 10.56 171 142093 161785 90324398
Abscess intestinal 15.37 10.56 17 142247 1911 90484272
Bronchopulmonary aspergillosis 15.33 10.56 46 142218 11352 90474831
Haematemesis 15.30 10.56 98 142166 33628 90452555
Sinusitis bacterial 15.26 10.56 17 142247 1926 90484257
Blood immunoglobulin G decreased 15.24 10.56 23 142241 3515 90482668
Nocardia sepsis 15.04 10.56 4 142260 18 90486165
Bradycardia 15.02 10.56 74 142190 83773 90402410
Pertussis 15.00 10.56 12 142252 895 90485288
Back disorder 14.97 10.56 11 142253 25620 90460563
Ecchymosis 14.97 10.56 48 142216 12275 90473908
Acne 14.94 10.56 86 142178 28421 90457762
Cortisol decreased 14.87 10.56 16 142248 1743 90484440
Eosinophilic pneumonia 14.85 10.56 20 142244 2753 90483430
Abdominal rigidity 14.82 10.56 19 142245 2493 90483690
Dyslipidaemia 14.76 10.56 42 142222 10065 90476118
Agranulocytosis 14.74 10.56 20 142244 34982 90451201
Septic shock 14.66 10.56 75 142189 84085 90402098
Foreign body in respiratory tract 14.65 10.56 8 142256 312 90485871
Gastrointestinal scarring 14.63 10.56 9 142255 440 90485743
Visual impairment 14.59 10.56 135 142129 132230 90353953
Small intestinal obstruction 14.54 10.56 69 142195 21165 90465018
Delayed puberty 14.54 10.56 6 142258 123 90486060
Vaginal fistula 14.52 10.56 10 142254 593 90485590
Bronchospasm paradoxical 14.40 10.56 6 142258 126 90486057
Faeces discoloured 14.40 10.56 69 142195 21251 90464932
Tracheostomy infection 14.27 10.56 5 142259 64 90486119
Weight gain poor 14.26 10.56 13 142251 1159 90485024
Coprolalia 14.23 10.56 4 142260 23 90486160
Gastrointestinal inflammation 14.14 10.56 32 142232 6664 90479519
Parosmia 14.06 10.56 33 142231 7036 90479147
Cushing's syndrome 14.04 10.56 10 142254 626 90485557
Anal abscess 14.02 10.56 29 142235 5679 90480504
Therapeutic response shortened 14.00 10.56 72 142192 22807 90463376
Device difficult to use 13.99 10.56 5 142259 17520 90468663
Diarrhoea 13.97 10.56 1277 140987 937913 89548270
Lung neoplasm malignant 13.90 10.56 75 142189 24198 90461985
Serum sickness 13.82 10.56 22 142242 3520 90482663
Stridor 13.77 10.56 26 142238 4767 90481416
Rash pruritic 13.74 10.56 193 142071 82021 90404162
Oropharyngeal candidiasis 13.74 10.56 13 142251 1215 90484968
Drug level above therapeutic 13.67 10.56 29 142235 5780 90480403
Generalised tonic-clonic seizure 13.66 10.56 21 142243 34882 90451301
Pneumothorax 13.65 10.56 63 142201 19104 90467079
Laryngeal oedema 13.56 10.56 32 142232 6849 90479334
Laryngitis 13.54 10.56 38 142226 50715 90435468
Sacroiliitis 13.53 10.56 24 142240 4195 90481988
Large intestinal ulcer 13.49 10.56 23 142241 3894 90482289
Skin atrophy 13.48 10.56 28 142236 5501 90480682
Obstructive pancreatitis 13.43 10.56 10 142254 671 90485512
Hypoalbuminaemia 13.42 10.56 55 142209 15842 90470341
Nasal discomfort 13.41 10.56 28 142236 5520 90480663
Symptom recurrence 13.31 10.56 23 142241 3936 90482247
Foetal death 13.31 10.56 8 142256 20715 90465468
Colectomy 13.26 10.56 21 142243 3346 90482837
Device ineffective 13.20 10.56 7 142257 257 90485926
Bladder hypertrophy 13.19 10.56 9 142255 526 90485657
Hyperplastic cholecystopathy 13.15 10.56 6 142258 158 90486025
Chills 13.09 10.56 285 141979 131696 90354487
Imperforate hymen 13.09 10.56 3 142261 6 90486177
Haemophagocytic lymphohistiocytosis 13.06 10.56 4 142260 15455 90470728
Growth retardation 12.98 10.56 15 142249 1768 90484415
Neoplasm skin 12.93 10.56 20 142244 3122 90483061
Herpes virus infection 12.92 10.56 30 142234 6354 90479829
Sinusitis 12.82 10.56 660 141604 342428 90143755
Rib fracture 12.73 10.56 78 142186 26357 90459826
Mucosal inflammation 12.69 10.56 47 142217 57578 90428605
Tracheobronchitis 12.67 10.56 14 142250 1571 90484612
Tricuspid valve incompetence 12.67 10.56 56 142208 16675 90469508
Hypocalcaemia 12.63 10.56 30 142234 42338 90443845
Norovirus infection 12.57 10.56 15 142249 1829 90484354
Dysphoria 12.54 10.56 29 142235 6125 90480058
Atopy 12.54 10.56 7 142257 285 90485898
Drug withdrawal syndrome 12.51 10.56 16 142248 28707 90457476
Somnolence 12.50 10.56 242 142022 208842 90277341
Full blood count decreased 12.46 10.56 17 142247 29672 90456511
Paranasal sinus hyposecretion 12.46 10.56 6 142258 179 90486004
Respiratory rate increased 12.45 10.56 54 142210 15947 90470236
Pallor 12.39 10.56 94 142170 34071 90452112
Congenital naevus 12.31 10.56 6 142258 184 90485999
Pancreatic calcification 12.31 10.56 4 142260 40 90486143
Hypercalcaemia 12.30 10.56 94 142170 34146 90452037
Forced vital capacity decreased 12.29 10.56 12 142252 1166 90485017
Cytopenia 12.28 10.56 6 142258 17443 90468740
Oxygen saturation decreased 12.27 10.56 237 142027 107246 90378937
Arteriosclerosis coronary artery 12.21 10.56 38 142226 9565 90476618
Transaminases increased 12.20 10.56 100 142164 37092 90449091
Nephropathy 12.17 10.56 37 142227 9198 90476985
Orthostatic hypotension 12.17 10.56 30 142234 41797 90444386
Inflammation 12.16 10.56 202 142062 178390 90307793
Faecal calprotectin decreased 12.13 10.56 4 142260 42 90486141
Jaundice cholestatic 12.09 10.56 39 142225 10004 90476179
Apallic syndrome 12.05 10.56 10 142254 786 90485397
Rhinovirus infection 12.04 10.56 28 142236 5935 90480248
Influenza 12.04 10.56 295 141969 138969 90347214
Perfume sensitivity 12.03 10.56 11 142253 984 90485199
Face oedema 11.99 10.56 70 142194 23248 90462935
Fistula 11.98 10.56 44 142220 12045 90474138
Blood calcium decreased 11.96 10.56 18 142246 30164 90456019
Heart rate irregular 11.93 10.56 72 142192 24196 90461987
Hypoaesthesia eye 11.90 10.56 8 142256 456 90485727
Gait disturbance 11.75 10.56 315 141949 260181 90226002
Device use issue 11.75 10.56 21 142243 3692 90482491
Orbital infection 11.70 10.56 5 142259 112 90486071
Skin dystrophy 11.65 10.56 4 142260 48 90486135
Exposure during pregnancy 11.63 10.56 285 141979 238125 90248058
Hypothalamic pituitary adrenal axis suppression 11.59 10.56 7 142257 331 90485852
Anastomotic complication 11.57 10.56 7 142257 332 90485851
Photosensitivity reaction 11.57 10.56 57 142207 17750 90468433
Rectal abscess 11.57 10.56 13 142251 1487 90484696
Red blood cell agglutination 11.57 10.56 3 142261 12 90486171
Bronchial hyperreactivity 11.55 10.56 15 142249 1993 90484190
Blood immunoglobulin E 11.50 10.56 4 142260 50 90486133
Dermatitis contact 11.45 10.56 47 142217 13548 90472635
Intestinal anastomosis complication 11.44 10.56 7 142257 339 90485844
Granulomatosis with polyangiitis 11.41 10.56 17 142247 2568 90483615
Renal impairment 11.41 10.56 108 142156 105313 90380870
Blood pressure systolic 11.36 10.56 4 142260 52 90486131
Infusion site reaction 11.34 10.56 8 142256 19031 90467152
Mycotic allergy 11.30 10.56 11 142253 1065 90485118
Pneumonia viral 11.30 10.56 35 142229 8788 90477395
Fungal disease carrier 11.29 10.56 4 142260 53 90486130
Depression 11.20 10.56 373 141891 300228 90185955
Intestinal villi atrophy 11.18 10.56 7 142257 353 90485830
Congestive cardiomyopathy 11.17 10.56 31 142233 7323 90478860
Nail dystrophy 11.16 10.56 12 142252 1306 90484877
Uveitis 11.13 10.56 52 142212 15851 90470332
Poisoning deliberate 11.11 10.56 6 142258 16480 90469703
Anti-saccharomyces cerevisiae antibody test positive 11.09 10.56 4 142260 56 90486127
Haematotoxicity 11.04 10.56 3 142261 12532 90473651
Dysarthria 11.00 10.56 46 142218 54436 90431747
Heart sounds abnormal 10.97 10.56 9 142255 696 90485487
Pus in stool 10.96 10.56 4 142260 58 90486125
Collateral circulation 10.86 10.56 3 142261 16 90486167
Choking sensation 10.85 10.56 21 142243 3921 90482262
Mental status changes 10.81 10.56 35 142229 44644 90441539
Pustular psoriasis 10.79 10.56 8 142256 18548 90467635
Otorrhoea 10.78 10.56 14 142250 1861 90484322
Product residue present 10.78 10.56 22 142242 4269 90481914
Mitochondrial cytopathy 10.76 10.56 6 142258 244 90485939
Spinal fusion surgery 10.70 10.56 3 142261 12280 90473903
Rash maculo-papular 10.66 10.56 31 142233 40902 90445281
Congenital tricuspid valve incompetence 10.58 10.56 5 142259 143 90486040
Lactic acidosis 10.57 10.56 42 142222 50421 90435762

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 1169.36 10.74 979 84114 61335 42474907
Wheezing 679.40 10.74 683 84410 54098 42482144
Full blood count abnormal 421.54 10.74 400 84693 29476 42506766
Loss of personal independence in daily activities 417.60 10.74 506 84587 49310 42486932
Productive cough 376.74 10.74 489 84604 51078 42485164
Dyspnoea 362.09 10.74 1790 83303 440831 42095411
Eosinophilic granulomatosis with polyangiitis 347.47 10.74 216 84877 8422 42527820
Frequent bowel movements 329.68 10.74 301 84792 21106 42515136
Therapeutic product effect incomplete 325.28 10.74 540 84553 70399 42465843
Bronchiectasis 324.73 10.74 277 84816 17742 42518500
Obstructive airways disorder 294.38 10.74 302 84791 24457 42511785
Sleep disorder due to a general medical condition 281.71 10.74 252 84841 17201 42519041
Colitis ulcerative 239.22 10.74 278 84815 25897 42510345
Dust allergy 236.63 10.74 142 84951 5190 42531052
Mycotic allergy 234.70 10.74 137 84956 4754 42531488
Chronic obstructive pulmonary disease 234.28 10.74 438 84655 62676 42473566
Toxicity to various agents 230.23 10.74 85 85008 229051 42307191
Spirometry abnormal 228.25 10.74 137 84956 5009 42531233
Mite allergy 222.94 10.74 134 84959 4912 42531330
Conjunctivitis allergic 210.79 10.74 137 84956 5774 42530468
Neuritis 209.24 10.74 139 84954 6081 42530161
Pulmonary vasculitis 193.98 10.74 133 84960 6133 42530109
Lung disorder 190.96 10.74 343 84750 47580 42488662
Cough 189.37 10.74 780 84313 177323 42358919
Respiratory symptom 182.46 10.74 162 84931 10944 42525298
Condition aggravated 177.38 10.74 1004 84089 259750 42276492
Forced expiratory volume decreased 174.86 10.74 135 84958 7495 42528747
Breath sounds abnormal 172.54 10.74 163 84930 11930 42524312
Impaired quality of life 170.42 10.74 174 84919 14003 42522239
Drug abuse 169.00 10.74 10 85083 104761 42431481
Neurological symptom 166.65 10.74 147 84946 9844 42526398
Steroid dependence 154.19 10.74 119 84974 6603 42529639
Chest discomfort 154.05 10.74 371 84722 63245 42472997
Haematochezia 151.50 10.74 350 84743 58086 42478156
Normochromic normocytic anaemia 148.89 10.74 132 84961 8899 42527343
Encephalitis cytomegalovirus 146.70 10.74 64 85029 1175 42535067
Acute kidney injury 146.52 10.74 323 84770 367014 42169228
Completed suicide 144.74 10.74 13 85080 96452 42439790
Congenital hiatus hernia 136.62 10.74 107 84986 6067 42530175
Total lung capacity abnormal 134.45 10.74 93 85000 4350 42531892
Vasculitis 133.52 10.74 174 84919 18220 42518022
Death 132.33 10.74 490 84603 470695 42065547
Febrile neutropenia 131.19 10.74 107 84986 185596 42350646
Haemoptysis 126.85 10.74 283 84810 45884 42490358
Nodule 126.16 10.74 140 84953 12394 42523848
Growth failure 124.39 10.74 30 85063 58 42536184
Pulmonary alveolar haemorrhage 121.57 10.74 149 84944 14667 42521575
Rhinitis 115.79 10.74 131 84962 11846 42524396
Pulmonary fibrosis 115.35 10.74 198 84895 26483 42509759
Antineutrophil cytoplasmic antibody positive 115.08 10.74 84 85009 4281 42531961
Neutropenia 114.34 10.74 138 84955 199293 42336949
Epstein-Barr viraemia 109.51 10.74 64 85029 2225 42534017
Faecal calprotectin increased 108.57 10.74 71 85022 3023 42533219
Catarrh 101.68 10.74 89 85004 5897 42530345
Burns second degree 100.28 10.74 89 85004 6007 42530235
Disease progression 96.26 10.74 87 85006 143569 42392673
Parosmia 95.35 10.74 96 84997 7595 42528647
Nasal polyps 90.12 10.74 69 85024 3782 42532460
Night sweats 88.70 10.74 150 84943 19819 42516423
Malignant melanoma in situ 88.65 10.74 60 85033 2707 42533535
Gastrooesophageal reflux disease 86.71 10.74 241 84852 44782 42491460
Adenovirus infection 86.27 10.74 86 85007 6723 42529519
Bronchopulmonary aspergillosis allergic 85.50 10.74 72 85021 4526 42531716
BK virus infection 84.78 10.74 96 84997 8688 42527554
Hypopnoea 84.46 10.74 91 85002 7791 42528451
Gingival pain 83.97 10.74 94 84999 8400 42527842
Cushingoid 83.81 10.74 63 85030 3359 42532883
Systemic lupus erythematosus 83.43 10.74 98 84995 9226 42527016
Sputum discoloured 83.29 10.74 102 84991 10030 42526212
Arteriosclerosis coronary artery 82.57 10.74 140 84953 18537 42517705
Malignant neoplasm progression 82.19 10.74 58 85035 108342 42427900
Inappropriate schedule of product administration 82.03 10.74 394 84699 95508 42440734
Arteriosclerosis 81.06 10.74 136 84957 17853 42518389
Micturition urgency 80.87 10.74 109 84984 11789 42524453
Thrombocytopenia 76.73 10.74 166 84927 190113 42346129
Impaired work ability 76.50 10.74 107 84986 11984 42524258
Blood immunoglobulin E increased 76.28 10.74 61 85032 3564 42532678
Fall 72.93 10.74 233 84860 234287 42301955
Ileal stenosis 70.46 10.74 45 85048 1839 42534403
Nipple swelling 69.06 10.74 27 85066 370 42535872
Hypotension 68.14 10.74 274 84819 257357 42278885
Intentional product use issue 67.21 10.74 303 84790 71530 42464712
Nausea 66.38 10.74 492 84601 396307 42139935
Adrenal suppression 65.53 10.74 34 85059 931 42535311
Cytokine release syndrome 64.15 10.74 7 85086 44520 42491722
Weight decreased 63.82 10.74 665 84428 207283 42328959
Coagulation factor deficiency 59.59 10.74 22 85071 255 42535987
Dyspnoea exertional 57.40 10.74 225 84868 49923 42486319
Platelet count decreased 55.75 10.74 121 84972 138460 42397782
Cardiac murmur 55.46 10.74 95 84998 12680 42523562
Intentional overdose 53.42 10.74 18 85075 51438 42484804
Sinusitis 53.17 10.74 211 84882 47081 42489161
Cystitis haemorrhagic 52.66 10.74 69 85024 7260 42528982
White blood cell count decreased 52.64 10.74 87 85006 110309 42425933
Drug interaction 52.63 10.74 315 84778 266684 42269558
Benign prostatic hyperplasia 52.23 10.74 124 84969 20928 42515314
Mucous stools 51.87 10.74 42 85051 2498 42533744
Stenotrophomonas infection 51.07 10.74 49 85044 3655 42532587
Proctitis 50.60 10.74 44 85049 2889 42533353
Stress 50.30 10.74 198 84895 44014 42492228
Colitis 50.13 10.74 205 84888 46367 42489875
Capillaritis 50.13 10.74 39 85054 2189 42534053
Anaemia 49.96 10.74 341 84752 279937 42256305
Hypercholesterolaemia 49.90 10.74 91 85002 12758 42523484
Eosinophil count increased 49.33 10.74 82 85011 10681 42525561
Neutrophil count decreased 49.29 10.74 33 85060 63382 42472860
Mechanical ventilation complication 48.37 10.74 25 85068 679 42535563
Joint injury 47.25 10.74 96 84997 14580 42521662
Off label use 47.05 10.74 1633 83460 636702 41899540
Coagulation factor V level abnormal 47.04 10.74 16 85077 143 42536099
Bronchiolitis 47.04 10.74 48 85045 3858 42532384
Renal impairment 46.20 10.74 94 84999 110134 42426108
Bronchospasm 45.98 10.74 88 85005 12797 42523445
Nipple pain 45.78 10.74 28 85065 1059 42535183
Pulmonary embolism 45.29 10.74 400 84693 119212 42417030
Respiratory distress 44.94 10.74 184 84909 41636 42494606
Ileocaecal resection 44.55 10.74 20 85073 394 42535848
Factor V Leiden mutation 44.29 10.74 17 85076 221 42536021
Neuropathy peripheral 44.29 10.74 85 85008 101768 42434474
Defaecation urgency 43.77 10.74 45 85048 3649 42532593
Mucosal inflammation 43.61 10.74 22 85071 49352 42486890
Therapeutic product effect decreased 43.46 10.74 174 84919 38976 42497266
Vomiting 43.37 10.74 370 84723 289353 42246889
Suicide attempt 43.09 10.74 19 85074 46081 42490161
Migraine 43.09 10.74 130 84963 25284 42510958
Electrocardiogram QT prolonged 42.90 10.74 21 85072 47924 42488318
Hypothyroidism 42.59 10.74 151 84942 31933 42504309
Cushing's syndrome 42.48 10.74 19 85074 371 42535871
Swollen tongue 42.20 10.74 115 84978 21116 42515126
Rectal haemorrhage 41.80 10.74 203 84890 49403 42486839
Sleep disorder 41.38 10.74 198 84895 47897 42488345
Emphysema 41.21 10.74 80 85013 11755 42524487
Stomatitis 40.74 10.74 25 85068 50304 42485938
Alcohol poisoning 40.62 10.74 62 85031 7512 42528730
Anal fissure 40.27 10.74 51 85042 5188 42531054
Delirium 39.92 10.74 28 85065 52491 42483751
Rhabdomyolysis 39.54 10.74 59 85034 77960 42458282
Nasal congestion 39.29 10.74 139 84954 29362 42506880
Overdose 39.02 10.74 96 84997 105168 42431074
Generalised oedema 38.76 10.74 91 85002 15245 42520997
Lower respiratory tract infection 38.66 10.74 174 84919 41032 42495210
Upper respiratory tract infection 38.02 10.74 176 84917 41997 42494245
Lung diffusion test decreased 37.94 10.74 23 85070 856 42535386
Delayed puberty 37.69 10.74 15 85078 216 42536026
Leukopenia 37.42 10.74 57 85036 74689 42461553
Palpitations 37.29 10.74 200 84893 50597 42485645
Aphthous ulcer 37.00 10.74 52 85041 5849 42530393
Acute graft versus host disease 36.86 10.74 62 85031 8153 42528089
Respiratory tract infection 36.77 10.74 126 84967 26196 42510046
Coma 36.35 10.74 32 85061 53522 42482720
Product use in unapproved indication 35.91 10.74 542 84551 183914 42352328
Cardiac arrest 35.77 10.74 106 84987 109214 42427028
Hypoxia 35.56 10.74 250 84843 69536 42466706
Renal failure 35.37 10.74 157 84936 143569 42392673
Cardio-respiratory arrest 35.23 10.74 39 85054 58597 42477645
Serotonin syndrome 34.94 10.74 5 85088 25840 42510402
Periumbilical abscess 34.93 10.74 11 85082 75 42536167
Inflammatory bowel disease 34.79 10.74 39 85054 3490 42532752
Dysarthria 34.77 10.74 18 85075 39789 42496453
Cytomegalovirus infection reactivation 34.67 10.74 72 85021 11106 42525136
Psychotic disorder 34.44 10.74 8 85085 29200 42507042
Loss of therapeutic response 34.38 10.74 25 85068 1266 42534976
Intestinal fistula 34.03 10.74 24 85069 1158 42535084
Psoriatic arthropathy 33.36 10.74 5 85088 24962 42511280
Emphysematous cholecystitis 33.19 10.74 11 85082 90 42536152
Multiple allergies 33.04 10.74 39 85054 3689 42532553
Pneumonia adenoviral 33.03 10.74 16 85077 377 42535865
Metabolic acidosis 32.83 10.74 33 85060 51825 42484417
Constipation 32.70 10.74 190 84903 162101 42374141
Haemosiderosis 32.07 10.74 15 85078 326 42535916
Respiratory disorder 31.98 10.74 107 84986 21978 42514264
Eosinophilic oesophagitis 31.69 10.74 19 85074 693 42535549
Intestinal stenosis 31.15 10.74 33 85060 2771 42533471
Sedation 31.04 10.74 11 85082 30464 42505778
Urinary tract infection 30.55 10.74 99 84994 99185 42437057
Eczema 30.53 10.74 142 84951 33944 42502298
Dehydration 30.17 10.74 163 84930 141604 42394638
Blood iron decreased 30.12 10.74 49 85044 6269 42529973
Obstruction 30.09 10.74 34 85059 3069 42533173
Tinnitus 30.05 10.74 126 84967 28812 42507430
Osteoporosis 29.88 10.74 81 85012 14825 42521417
Upper-airway cough syndrome 29.67 10.74 40 85053 4326 42531916
Blood immunoglobulin E decreased 29.56 10.74 9 85084 54 42536188
Blood pressure increased 29.35 10.74 322 84771 101606 42434636
Graft versus host disease in gastrointestinal tract 28.86 10.74 43 85050 5100 42531142
Chronic kidney disease 28.85 10.74 31 85062 47210 42489032
Neoplasm progression 28.64 10.74 11 85082 28989 42507253
Lactic acidosis 28.43 10.74 29 85064 45232 42491010
Transient ischaemic attack 28.36 10.74 138 84955 33601 42502641
Colitis microscopic 28.14 10.74 33 85060 3100 42533142
Hepatic function abnormal 28.11 10.74 37 85056 51530 42484712
Polyp 27.95 10.74 40 85053 4574 42531668
Lactobacillus infection 27.78 10.74 14 85079 360 42535882
Respiratory tract infection bacterial 27.74 10.74 26 85067 1883 42534359
Therapeutic reaction time decreased 27.72 10.74 27 85066 2051 42534191
Nightmare 27.62 10.74 111 84982 24901 42511341
Cyanosis 27.49 10.74 79 85014 14952 42521290
Altered state of consciousness 27.44 10.74 12 85081 29247 42506995
Mycobacterium test positive 27.34 10.74 15 85078 461 42535781
Gait disturbance 27.27 10.74 102 84991 97898 42438344
Haemoglobin decreased 27.27 10.74 154 84939 132317 42403925
Tubulointerstitial nephritis 27.21 10.74 130 84963 31418 42504824
Plasma cell myeloma 27.12 10.74 33 85060 47545 42488697
Circumstance or information capable of leading to medication error 26.76 10.74 29 85064 2499 42533743
Rubber sensitivity 26.63 10.74 14 85079 394 42535848
Memory impairment 26.41 10.74 37 85056 50185 42486057
Drug reaction with eosinophilia and systemic symptoms 26.38 10.74 27 85066 42048 42494194
Infective pulmonary exacerbation of cystic fibrosis 26.19 10.74 52 85041 7766 42528476
Herpes zoster meningoencephalitis 26.18 10.74 15 85078 502 42535740
Drug ineffective 26.13 10.74 1521 83572 628676 41907566
Dyspnoea at rest 25.98 10.74 37 85056 4212 42532030
Use of accessory respiratory muscles 25.94 10.74 15 85078 511 42535731
Nasal obstruction 25.79 10.74 19 85074 982 42535260
Cardiogenic shock 25.79 10.74 20 85073 35620 42500622
Ascites 25.78 10.74 46 85047 56632 42479610
Intentional device misuse 25.61 10.74 12 85081 262 42535980
Skin striae 25.53 10.74 17 85076 746 42535496
Rhonchi 25.40 10.74 26 85067 2097 42534145
Encephalopathy 25.37 10.74 27 85066 41306 42494936
Allergy to animal 25.32 10.74 15 85078 535 42535707
Mental status changes 25.31 10.74 28 85065 42087 42494155
Decreased appetite 25.25 10.74 255 84838 192882 42343360
Asphyxia 25.09 10.74 53 85040 8273 42527969
Neuroleptic malignant syndrome 25.08 10.74 6 85087 21466 42514776
Neurotoxicity 25.03 10.74 8 85085 23643 42512599
Acute myocardial infarction 24.87 10.74 49 85044 58116 42478126
Diabetic ketoacidosis 24.69 10.74 7 85086 22360 42513882
Large intestine polyp 24.54 10.74 56 85037 9209 42527033
Tumour lysis syndrome 24.46 10.74 7 85086 22224 42514018
Pouchitis 24.42 10.74 18 85075 931 42535311
Cataract 24.18 10.74 123 84970 30481 42505761
Drug resistance 23.80 10.74 20 85073 34228 42502014
Throat clearing 23.73 10.74 15 85078 602 42535640
Joint swelling 23.69 10.74 64 85029 67958 42468284
Infection parasitic 23.56 10.74 13 85080 404 42535838
Palmar-plantar erythrodysaesthesia syndrome 23.56 10.74 6 85087 20576 42515666
Hyperkalaemia 23.53 10.74 82 85011 80376 42455866
Full blood count decreased 23.52 10.74 6 85087 20554 42515688
Precancerous condition 23.45 10.74 9 85084 117 42536125
Hypoglycaemia 23.44 10.74 53 85040 59801 42476441
Gastrointestinal haemorrhage 23.28 10.74 108 84985 97618 42438624
Disorientation 23.21 10.74 23 85070 36366 42499876
Sputum increased 23.07 10.74 30 85063 3133 42533109
Gastrointestinal wall thickening 22.88 10.74 23 85070 1816 42534426
Respiratory tract infection viral 22.83 10.74 31 85062 3375 42532867
Pulmonary oedema 22.67 10.74 45 85048 53227 42483015
Medication error 22.63 10.74 128 84965 33026 42503216
Procedural pneumothorax 22.58 10.74 7 85086 45 42536197
Blood lactate dehydrogenase increased 22.47 10.74 12 85081 26069 42510173
Pharyngitis streptococcal 22.45 10.74 33 85060 3867 42532375
Fistula 22.27 10.74 49 85044 7863 42528379
Heart rate increased 22.19 10.74 182 84911 53073 42483169
Eye swelling 22.14 10.74 63 85030 11857 42524385
Enterocutaneous fistula 21.92 10.74 19 85074 1242 42535000
Graft versus host disease 21.80 10.74 66 85027 12859 42523383
Botulism 21.61 10.74 10 85083 212 42536030
Lymphopenia 21.59 10.74 8 85085 21555 42514687
Tachypnoea 21.47 10.74 93 85000 21569 42514673
Sinus operation 21.43 10.74 16 85077 844 42535398
Leukoplakia oral 21.42 10.74 9 85084 150 42536092
Renal disorder 21.30 10.74 16 85077 28964 42507278
Drug level below therapeutic 21.29 10.74 43 85050 6502 42529740
Ear infection 21.23 10.74 65 85028 12739 42523503
Back pain 21.18 10.74 181 84912 141595 42394647
Injury 21.17 10.74 9 85084 22307 42513935
Gastrointestinal inflammation 21.06 10.74 35 85058 4557 42531685
Prolonged expiration 21.04 10.74 11 85082 306 42535936
Blood creatinine increased 20.98 10.74 131 84962 109872 42426370
Hepatic cytolysis 20.81 10.74 14 85079 26830 42509412
Aspergillus infection 20.55 10.74 74 85019 15763 42520479
Extrapyramidal disorder 20.36 10.74 4 85089 16408 42519834
Septic shock 20.28 10.74 104 84989 91568 42444674
Pulmonary function test decreased 20.27 10.74 39 85054 5693 42530549
Hypoventilation 20.21 10.74 31 85062 3771 42532471
Seizure 19.81 10.74 150 84943 120411 42415831
Upper respiratory fungal infection 19.70 10.74 9 85084 185 42536057
Abscess intestinal 19.61 10.74 21 85072 1785 42534457
Gastrointestinal mucosa hyperaemia 19.56 10.74 11 85082 355 42535887
Acute myeloid leukaemia 19.53 10.74 10 85083 22246 42513996
Thrombosis 19.51 10.74 216 84877 68295 42467947
Faeces soft 19.34 10.74 35 85058 4877 42531365
Epstein-Barr virus infection reactivation 19.29 10.74 25 85068 2602 42533640
Rhinorrhoea 19.28 10.74 119 84974 31675 42504567
Loss of consciousness 19.19 10.74 107 84986 92247 42443995
Eye infection fungal 19.13 10.74 12 85081 475 42535767
Cystic fibrosis 19.05 10.74 22 85071 2033 42534209
Respiratory depression 18.90 10.74 7 85086 18861 42517381
Foetal distress syndrome 18.88 10.74 17 85076 1169 42535073
Drug level decreased 18.79 10.74 53 85040 9924 42526318
Lethargy 18.78 10.74 41 85052 46849 42489393
Rhinitis allergic 18.59 10.74 30 85063 3812 42532430
MAGIC syndrome 18.56 10.74 6 85087 45 42536197
Nephrectomy 18.53 10.74 15 85078 892 42535350
Hyperbilirubinaemia 18.51 10.74 9 85084 20626 42515616
Inspiratory capacity decreased 18.38 10.74 26 85067 2941 42533301
Dysgeusia 18.30 10.74 124 84969 34065 42502177
Psoriasis 18.25 10.74 44 85049 48560 42487682
Intentional self-injury 18.25 10.74 4 85089 15198 42521044
Acute graft versus host disease in liver 18.22 10.74 21 85072 1937 42534305
Gastroenteritis clostridial 18.20 10.74 11 85082 407 42535835
Acute graft versus host disease in intestine 17.97 10.74 30 85063 3921 42532321
Pleuritic pain 17.89 10.74 42 85051 7035 42529207
Graft versus host disease in skin 17.86 10.74 35 85058 5177 42531065
Cardiac disorder 17.83 10.74 45 85048 48887 42487355
Bradycardia 17.78 10.74 99 84994 85385 42450857
Asthenia 17.74 10.74 426 84667 280367 42255875
Arthritis 17.65 10.74 144 84949 41921 42494321
Gastrointestinal bacterial infection 17.54 10.74 13 85080 678 42535564
Transplant rejection 17.53 10.74 3 85090 13585 42522657
Product use issue 17.50 10.74 232 84861 76519 42459723
Anticoagulant therapy 17.46 10.74 32 85061 4503 42531739
Vertigo 17.46 10.74 123 84970 34224 42502018
Fungal oesophagitis 17.45 10.74 11 85082 439 42535803
Bronchitis 17.40 10.74 157 84936 47044 42489198
Hepatic failure 17.25 10.74 31 85062 38069 42498173
Physical examination abnormal 17.21 10.74 11 85082 450 42535792
Muscular weakness 17.21 10.74 97 84996 83401 42452841
Accidental overdose 17.16 10.74 106 84987 28224 42508018
Acne 17.07 10.74 63 85030 13581 42522661
Adrenal insufficiency 17.06 10.74 79 85014 18845 42517397
Product substitution error 17.02 10.74 5 85088 26 42536216
Fluctuance 17.02 10.74 5 85088 26 42536216
Polyneuropathy 16.95 10.74 8 85085 18653 42517589
Sepsis 16.90 10.74 288 84805 199046 42337196
Relapsing fever 16.89 10.74 8 85085 179 42536063
Musculoskeletal stiffness 16.80 10.74 59 85034 57706 42478536
Nasopharyngitis 16.77 10.74 248 84845 83748 42452494
Tracheitis 16.75 10.74 15 85078 1024 42535218
Terminal ileitis 16.67 10.74 12 85081 598 42535644
Visual evoked potentials abnormal 16.62 10.74 6 85087 65 42536177
Cardiac failure 16.60 10.74 135 84958 106721 42429521
Ileocolostomy 16.57 10.74 5 85088 29 42536213
Antacid therapy 16.56 10.74 32 85061 4685 42531557
Activated partial thromboplastin time shortened 16.56 10.74 11 85082 481 42535761
Cholestasis 16.52 10.74 25 85068 32854 42503388
Balance disorder 16.46 10.74 45 85048 47600 42488642
Respiratory tract haemorrhage 16.40 10.74 17 85076 1392 42534850
Granuloma 16.17 10.74 29 85064 4012 42532230
Myelodysplastic syndrome 16.16 10.74 13 85080 22732 42513510
Ventricular tachycardia 16.07 10.74 22 85071 30138 42506104
Emotional distress 16.07 10.74 6 85087 16087 42520155
Osteonecrosis of jaw 16.07 10.74 9 85084 19040 42517202
Dizziness 16.06 10.74 377 84716 248877 42287365
Ileal ulcer 15.96 10.74 14 85079 930 42535312
Cytomegalovirus enteritis 15.81 10.74 12 85081 649 42535593
Myocardial infarction 15.67 10.74 165 84928 123844 42412398
Tonsillitis fungal 15.66 10.74 3 85090 0 42536242
Anosmia 15.65 10.74 33 85060 5143 42531099
Withdrawal syndrome 15.63 10.74 5 85088 14770 42521472
Cerebral microangiopathy 15.62 10.74 8 85085 213 42536029
Asthmatic crisis 15.61 10.74 11 85082 530 42535712
Intestinal obstruction 15.44 10.74 100 84993 27058 42509184
Drug eruption 15.40 10.74 14 85079 23061 42513181
Status asthmaticus 15.29 10.74 9 85084 317 42535925
Adenoviral hepatitis 15.29 10.74 11 85082 548 42535694
Tracheal haemorrhage 15.29 10.74 11 85082 548 42535694
Diplopia 15.21 10.74 11 85082 20305 42515937
Iron overload 15.19 10.74 17 85076 1518 42534724
Penile erythema 15.19 10.74 8 85085 226 42536016
Hepatitis toxic 15.18 10.74 22 85071 2545 42533697
Aspartate aminotransferase increased 15.17 10.74 91 85002 77072 42459170
Abdominal adhesions 15.07 10.74 18 85075 1724 42534518
Hepatocellular injury 15.06 10.74 15 85078 23663 42512579
Jaundice 14.91 10.74 29 85064 34560 42501682
Haematuria 14.90 10.74 62 85031 57737 42478505
Small airways disease 14.77 10.74 5 85088 44 42536198
Bronchial disorder 14.73 10.74 16 85077 1382 42534860
Pneumonitis 14.71 10.74 39 85054 41679 42494563
Tuberculosis 14.68 10.74 49 85044 10050 42526192
Adrenal cortex necrosis 14.67 10.74 4 85089 15 42536227
Respiratory tract congestion 14.67 10.74 41 85052 7637 42528605
Gastrointestinal anastomotic leak 14.61 10.74 11 85082 588 42535654
Rales 14.57 10.74 53 85040 11347 42524895
Reversible airways obstruction 14.54 10.74 11 85082 592 42535650
CADASIL 14.34 10.74 6 85087 99 42536143
Hyposmia 14.24 10.74 9 85084 361 42535881
Retinal ischaemia 14.06 10.74 10 85083 489 42535753
Therapeutic response shortened 14.06 10.74 59 85034 13495 42522747
Bone marrow failure 14.04 10.74 28 85065 33065 42503177
Ejection fraction decreased 14.04 10.74 14 85079 22073 42514169
Crohn's disease 14.03 10.74 23 85070 2961 42533281
Pneumonia aspiration 14 10.74 52 85041 50026 42486216
Product administered to patient of inappropriate age 13.99 10.74 30 85063 4731 42531511
Hypomagnesaemia 13.99 10.74 22 85071 28466 42507776
Rheumatoid arthritis 13.98 10.74 41 85052 42399 42493843
Depressed level of consciousness 13.95 10.74 49 85044 47921 42488321
Pancytopenia 13.94 10.74 159 84934 117584 42418658
Hypercapnic coma 13.93 10.74 7 85086 179 42536063
Stenosis 13.90 10.74 19 85074 2082 42534160
Pancreatic cyst 13.84 10.74 13 85080 944 42535298
Cardiac failure congestive 13.82 10.74 107 84986 85495 42450747
Agranulocytosis 13.78 10.74 25 85068 30587 42505655
Pathogen resistance 13.77 10.74 3 85090 11447 42524795
Hallucination, visual 13.74 10.74 13 85080 21007 42515235
Cytopenia 13.73 10.74 9 85084 17488 42518754
Metastases to lung 13.73 10.74 3 85090 11421 42524821
Anaphylactic reaction 13.68 10.74 138 84955 42605 42493637
Rotavirus infection 13.66 10.74 10 85083 512 42535730
Synovitis 13.65 10.74 7 85086 15560 42520682
Dementia 13.59 10.74 8 85085 16472 42519770
Cognitive disorder 13.59 10.74 30 85063 34142 42502100
Laryngeal cryptococcosis 13.58 10.74 3 85090 3 42536239
Bronchial obstruction 13.56 10.74 17 85076 1712 42534530
Orthopnoea 13.53 10.74 32 85061 5385 42530857
Congenital anomaly 13.46 10.74 16 85077 1525 42534717
Atrial fibrillation 13.39 10.74 197 84896 139396 42396846
Oedema mouth 13.37 10.74 15 85078 1343 42534899
Gamma-glutamyltransferase increased 13.36 10.74 28 85065 32469 42503773
Hypothalamic pituitary adrenal axis suppression 13.26 10.74 8 85085 295 42535947
Paranasal sinus mucosal hypertrophy 13.24 10.74 5 85088 62 42536180
Hypercalcaemia 13.23 10.74 10 85083 18048 42518194
Nasal turbinate hypertrophy 13.22 10.74 7 85086 200 42536042
Pleural effusion 13.22 10.74 127 84966 97039 42439203
Ventricular fibrillation 13.20 10.74 25 85068 30098 42506144
Interstitial lung disease 13.18 10.74 97 84996 78365 42457877
Anamnestic reaction 13.17 10.74 5 85088 63 42536179
Adrenocortical insufficiency acute 13.12 10.74 19 85074 2196 42534046
Sopor 13.05 10.74 5 85088 13197 42523045
Peak expiratory flow rate decreased 12.85 10.74 6 85087 130 42536112
Drug level above therapeutic 12.76 10.74 33 85060 5873 42530369
Alanine aminotransferase increased 12.69 10.74 114 84979 88292 42447950
Graft versus host disease in liver 12.67 10.74 16 85077 1623 42534619
Diarrhoea haemorrhagic 12.66 10.74 39 85054 7668 42528574
Abdominal abscess 12.63 10.74 30 85063 5063 42531179
Small intestinal stenosis 12.62 10.74 12 85081 885 42535357
Short-bowel syndrome 12.57 10.74 8 85085 325 42535917
Apoptosis 12.52 10.74 10 85083 583 42535659
Magnetic resonance imaging spinal abnormal 12.44 10.74 6 85087 140 42536102
Secondary adrenocortical insufficiency 12.43 10.74 18 85075 2081 42534161
Bacterial toxaemia 12.40 10.74 6 85087 141 42536101
Terminal insomnia 12.37 10.74 12 85081 907 42535335
Insomnia 12.37 10.74 164 84929 118089 42418153
Mitral valve incompetence 12.25 10.74 9 85084 16480 42519762
Schizophrenia 12.22 10.74 3 85090 10547 42525695
Intestinal anastomosis 12.15 10.74 9 85084 469 42535773
Nephropathy toxic 12.15 10.74 66 85027 16772 42519470
Ileostomy 12.14 10.74 13 85080 1105 42535137
Confusional state 12.07 10.74 249 84844 167348 42368894
Akathisia 12.05 10.74 3 85090 10448 42525794
Anxiety 12.04 10.74 316 84777 118244 42417998
Hyponatraemia 12.01 10.74 137 84956 101325 42434917
Middle ear effusion 11.99 10.74 11 85082 775 42535467
Contraindicated product administered 11.95 10.74 20 85073 25252 42510990
Pulmonary mass 11.90 10.74 64 85029 16201 42520041
Drug-induced liver injury 11.88 10.74 38 85055 38235 42498007
Large intestinal stenosis 11.87 10.74 17 85076 1946 42534296
Syncope 11.86 10.74 134 84959 99272 42436970
Drug use disorder 11.85 10.74 3 85090 10330 42525912
Lipid metabolism disorder 11.84 10.74 9 85084 488 42535754
Growth retardation 11.78 10.74 19 85074 2413 42533829
Gastrointestinal stoma complication 11.75 10.74 15 85078 1538 42534704
Hypogammaglobulinaemia 11.74 10.74 51 85042 11840 42524402
Blood bilirubin increased 11.73 10.74 44 85049 42208 42494034
Perfume sensitivity 11.71 10.74 6 85087 160 42536082
Necrotising ulcerative gingivostomatitis 11.70 10.74 5 85088 87 42536155
Hepatosplenic T-cell lymphoma 11.69 10.74 9 85084 497 42535745
Saccadic eye movement 11.67 10.74 6 85087 161 42536081
Analgesic therapy 11.65 10.74 34 85059 6490 42529752
Sinus polyp 11.61 10.74 7 85086 258 42535984
Febrile bone marrow aplasia 11.59 10.74 3 85090 10178 42526064
Adverse reaction 11.55 10.74 25 85068 3968 42532274
Skin lesion 11.52 10.74 23 85070 27151 42509091
Gastrointestinal stenosis 11.41 10.74 6 85087 169 42536073
Corneal lesion 11.40 10.74 5 85088 93 42536149
Respiration abnormal 11.34 10.74 25 85068 4017 42532225
Small intestinal resection 11.34 10.74 10 85083 669 42535573
Blood pressure systolic increased 11.33 10.74 95 84998 27873 42508369
Haemolytic anaemia 11.33 10.74 5 85088 12122 42524120
Anastomotic fistula 11.30 10.74 5 85088 95 42536147
Enterococcal infection 11.19 10.74 5 85088 12034 42524208
Erythema nodosum 11.16 10.74 16 85077 1832 42534410
Drug therapy 11.15 10.74 33 85060 6347 42529895
Complicated appendicitis 11.10 10.74 4 85089 43 42536199
Increased upper airway secretion 11.08 10.74 19 85074 2537 42533705
Haemothorax 11.05 10.74 29 85064 5207 42531035
Urinary tract pain 11.02 10.74 5 85088 101 42536141
Vanishing bile duct syndrome 11.01 10.74 16 85077 1855 42534387
Cerebral artery embolism 11.01 10.74 12 85081 1041 42535201
Carotid arteriosclerosis 11.00 10.74 18 85075 2314 42533928
Sputum purulent 10.93 10.74 10 85083 702 42535540
Abdominal discomfort 10.92 10.74 211 84882 75044 42461198
Posterior reversible encephalopathy syndrome 10.90 10.74 6 85087 12815 42523427
Kidney infection 10.88 10.74 34 85059 6736 42529506
Breath holding 10.85 10.74 5 85088 105 42536137
Face oedema 10.85 10.74 55 85038 13611 42522631
Haematemesis 10.82 10.74 28 85065 30171 42506071
Brain oedema 10.78 10.74 10 85083 16317 42519925

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 2415.44 10.23 2583 194110 247708 110144898
Full blood count abnormal 1228.13 10.23 921 195772 55131 110337475
Obstructive airways disorder 1093.54 10.23 795 195898 45354 110347252
Wheezing 1027.91 10.23 1719 194974 253511 110139095
Dyspnoea 843.30 10.23 4039 192654 1102833 109289773
Cough 690.72 10.23 2093 194600 459548 109933058
Loss of personal independence in daily activities 606.67 10.23 1013 195680 149007 110243599
Productive cough 584.73 10.23 860 195833 113445 110279161
Sleep disorder due to a general medical condition 551.36 10.23 566 196127 51546 110341060
Breath sounds abnormal 537.54 10.23 409 196284 24995 110367611
Chest discomfort 524.78 10.23 1034 195659 172814 110219792
Bronchiectasis 517.92 10.23 466 196227 36027 110356579
Colitis ulcerative 516.26 10.23 662 196031 76701 110315905
Therapeutic product effect incomplete 493.19 10.23 1172 195521 222633 110169973
Nasal polyps 477.83 10.23 296 196397 12904 110379702
Frequent bowel movements 463.99 10.23 603 196090 70787 110321819
Eosinophilic granulomatosis with polyangiitis 436.68 10.23 259 196434 10427 110382179
Chronic obstructive pulmonary disease 417.20 10.23 719 195974 108439 110284167
Toxicity to various agents 390.81 10.23 183 196510 480372 109912234
Haematochezia 380.23 10.23 713 195980 114811 110277795
Upper-airway cough syndrome 368.28 10.23 270 196423 15587 110377019
Chronic sinusitis 361.22 10.23 323 196370 24761 110367845
Hand deformity 353.89 10.23 7 196686 218499 110174107
Respiratory symptom 339.27 10.23 251 196442 14694 110377912
Completed suicide 321.55 10.23 30 196663 242351 110150255
Rhinitis allergic 319.81 10.23 261 196432 17661 110374945
Sputum discoloured 316.53 10.23 315 196378 27630 110364976
Anti-cyclic citrullinated peptide antibody positive 306.89 10.23 3 196690 181981 110210625
Impaired quality of life 303.03 10.23 318 196375 29699 110362907
Duodenal ulcer perforation 294.83 10.23 4 196689 177696 110214910
Glossodynia 293.10 10.23 28 196665 221976 110170630
Dust allergy 289.35 10.23 162 196531 5839 110386767
Forced expiratory volume decreased 287.28 10.23 216 196477 12960 110379646
Pericarditis 278.05 10.23 32 196661 219082 110173524
Helicobacter infection 272.20 10.23 12 196681 181865 110210741
Nasal congestion 270.68 10.23 563 196130 97719 110294887
Psoriatic arthropathy 248.99 10.23 29 196664 196732 110195874
Mycotic allergy 247.70 10.23 146 196547 5808 110386798
Eosinophil count increased 241.51 10.23 239 196454 20819 110371787
Mite allergy 240.64 10.23 142 196551 5661 110386945
Spirometry abnormal 239.79 10.23 139 196554 5358 110387248
Impaired healing 234.55 10.23 35 196658 196682 110195924
Bronchial secretion retention 227.05 10.23 130 196563 4894 110387712
Blood test abnormal 223.71 10.23 265 196428 28289 110364317
Drug abuse 222.38 10.23 27 196666 177384 110215222
Bronchopulmonary aspergillosis allergic 217.50 10.23 153 196540 8273 110384333
Conjunctivitis allergic 217.42 10.23 142 196551 6789 110385817
Stomatitis 216.29 10.23 105 196588 270137 110122469
Gastrooesophageal reflux disease 215.15 10.23 757 195936 179219 110213387
Haemoptysis 210.98 10.23 421 196272 70933 110321673
Folliculitis 208.94 10.23 26 196667 167627 110224979
Wound 208.51 10.23 78 196615 234359 110158247
Febrile neutropenia 206.21 10.23 157 196536 316610 110075996
Vasculitis 205.48 10.23 285 196408 35588 110357018
Pulmonary vasculitis 204.80 10.23 134 196559 6426 110386180
Neuritis 204.23 10.23 140 196553 7259 110385347
Female genital tract fistula 201.63 10.23 194 196499 16325 110376281
Steroid dependence 200.73 10.23 146 196547 8323 110384283
Blood immunoglobulin E increased 200.46 10.23 139 196554 7343 110385263
Neutropenia 198.61 10.23 224 196469 374396 110018210
Pulmonary function test abnormal 196.00 10.23 118 196575 4882 110387724
Weight decreased 195.95 10.23 1464 195229 466593 109926013
Contraindicated product administered 194.84 10.23 99 196594 248168 110144438
Blister 187.09 10.23 85 196608 227291 110165315
Proctitis 182.88 10.23 186 196507 16741 110375865
Synovitis 182.06 10.23 133 196560 273959 110118647
Acute kidney injury 181.32 10.23 555 196138 634875 109757731
Condition aggravated 177.98 10.23 2043 194650 732793 109659813
Liver injury 176.47 10.23 28 196665 150385 110242221
Alopecia 175.55 10.23 235 196458 364518 110028088
Faecal calprotectin increased 171.10 10.23 121 196572 6598 110386008
Macular degeneration 168.00 10.23 200 196493 21459 110371147
Eosinophilia 167.88 10.23 339 196354 57597 110335009
Rhinorrhoea 167.71 10.23 481 196212 102185 110290421
Dyspnoea exertional 165.61 10.23 483 196210 103577 110289029
Inappropriate schedule of product administration 165.13 10.23 759 195934 202878 110189728
Ear pruritus 164.93 10.23 122 196571 7138 110385468
Therapeutic reaction time decreased 162.77 10.23 107 196586 5172 110387434
Reversible airways obstruction 161.49 10.23 82 196611 2417 110390189
Swelling 161.10 10.23 234 196459 350807 110041799
Bronchospasm 159.54 10.23 231 196462 30008 110362598
Blood cholesterol increased 158.49 10.23 65 196628 184720 110207886
Off label use 157.69 10.23 3629 193064 1496556 108896050
Irritable bowel syndrome 157.54 10.23 48 196645 164167 110228439
Bursitis 157.45 10.23 22 196671 129896 110262710
Chest X-ray abnormal 154.37 10.23 125 196568 8362 110384244
Injury 154.25 10.23 61 196632 177204 110215402
Mobility decreased 152.79 10.23 119 196574 237303 110155303
Thrombocytopenia 151.02 10.23 242 196451 348643 110043963
Rhinitis 150.43 10.23 193 196500 22352 110370254
Total lung capacity abnormal 148.92 10.23 96 196597 4487 110388119
Congenital hiatus hernia 148.56 10.23 108 196585 6151 110386455
Lip dry 148.43 10.23 7 196686 100076 110292530
Joint range of motion decreased 146.77 10.23 21 196672 121811 110270795
Neurological symptom 146.31 10.23 159 196534 15449 110377157
Catarrh 146.19 10.23 114 196579 7221 110385385
Colitis 143.20 10.23 454 196239 101869 110290737
Systemic lupus erythematosus 142.63 10.23 145 196548 254193 110138413
Polycystic ovaries 142.53 10.23 95 196598 4701 110387905
Joint swelling 142.36 10.23 365 196328 442480 109950126
Vaginal flatulence 141.43 10.23 139 196554 12005 110380601
Heart rate increased 140.33 10.23 567 196126 143267 110249339
Normochromic normocytic anaemia 140.19 10.23 143 196550 12914 110379692
Intentional overdose 139.88 10.23 32 196661 132469 110260137
Arthropathy 139.58 10.23 184 196509 287338 110105268
Vital capacity decreased 136.82 10.23 69 196624 2004 110390602
Encephalitis cytomegalovirus 130.25 10.23 65 196628 1845 110390761
Procedural pain 130.23 10.23 230 196463 35335 110357271
Pulmonary mass 127.37 10.23 234 196459 37067 110355539
Paraesthesia oral 126.21 10.23 220 196473 33451 110359155
Cardiac murmur 123.94 10.23 184 196509 24444 110368162
Malignant neoplasm progression 123.49 10.23 79 196614 174488 110218118
Hypothyroidism 123.39 10.23 346 196347 72553 110320053
Confusional state 122.71 10.23 425 196268 468255 109924351
Death 122.48 10.23 735 195958 698134 109694472
Burns second degree 122.20 10.23 105 196588 7628 110384978
Defaecation urgency 120.73 10.23 110 196583 8637 110383969
Multiple allergies 120.35 10.23 128 196565 12135 110380471
Abdominal pain 120.29 10.23 1418 195275 511571 109881035
Sleep apnoea syndrome 119.97 10.23 239 196454 40208 110352398
Antineutrophil cytoplasmic antibody positive 116.89 10.23 86 196607 4990 110387616
White blood cell count decreased 116.30 10.23 142 196551 229248 110163358
Middle insomnia 114.60 10.23 161 196532 20341 110372265
Respiratory tract infection 114.49 10.23 333 196360 71284 110321322
Pulmonary alveolar haemorrhage 113.77 10.23 159 196534 19991 110372615
Bacterial disease carrier 111.43 10.23 62 196631 2207 110390399
Blood pressure increased 109.54 10.23 811 195882 257562 110135044
Arteriosclerosis coronary artery 105.94 10.23 173 196520 24945 110367661
Rales 105.17 10.23 171 196522 24568 110368038
Vaginal discharge 105.14 10.23 144 196549 17764 110374842
Pulmonary fibrosis 104.94 10.23 409 196284 101633 110290973
Parosmia 104.36 10.23 123 196570 13057 110379549
C-reactive protein abnormal 102.79 10.23 51 196642 129644 110262962
Radiculopathy 102.42 10.23 148 196545 19188 110373418
Wound infection 102.41 10.23 23 196670 96442 110296164
Growth failure 102.28 10.23 32 196661 243 110392363
Sensitisation 101.66 10.23 73 196620 4078 110388528
Total lung capacity decreased 101.21 10.23 91 196602 7023 110385583
Sinusitis fungal 100.99 10.23 62 196631 2658 110389948
Rectal haemorrhage 98.83 10.23 449 196244 119384 110273222
Asthmatic crisis 98.33 10.23 56 196637 2086 110390520
Hypopnoea 98.17 10.23 111 196582 11269 110381337
BK virus infection 96.71 10.23 118 196575 12988 110379618
Eosinophilic bronchitis 96.12 10.23 37 196656 549 110392057
Peripheral venous disease 95.68 10.23 17 196676 84100 110308506
Pneumonia 95.39 10.23 2133 194560 874581 109518025
Fall 95.29 10.23 655 196038 602827 109789779
Hepatic enzyme increased 94.44 10.23 276 196417 320616 110071990
Throat clearing 94.38 10.23 71 196622 4262 110388344
Emphysema 94.29 10.23 144 196549 19612 110372994
Decreased appetite 92.20 10.23 484 196209 475362 109917244
Delirium 91.60 10.23 64 196629 134961 110257645
Disease progression 91.43 10.23 185 196508 243849 110148757
Platelet count decreased 91.29 10.23 169 196524 230274 110162332
Sleep disorder due to general medical condition, insomnia type 90.83 10.23 37 196656 105606 110287000
Hypotension 90.07 10.23 554 196139 523295 109869311
Sputum culture positive 89.80 10.23 66 196627 3823 110388783
Anal fissure 89.73 10.23 99 196594 9782 110382824
Lung opacity 89.39 10.23 107 196586 11545 110381061
Adenovirus infection 89.38 10.23 104 196589 10890 110381716
Maternal exposure during pregnancy 89.02 10.23 201 196492 254682 110137924
Sneezing 88.92 10.23 184 196509 31800 110360806
Eczema 87.97 10.23 306 196387 71987 110320619
Drug level below therapeutic 87.60 10.23 106 196587 11567 110381039
Lung diffusion test abnormal 87.10 10.23 31 196662 364 110392242
Oral candidiasis 86.36 10.23 223 196470 44537 110348069
Malignant melanoma in situ 86.08 10.23 62 196631 3480 110389126
Palpitations 84.92 10.23 529 196164 158683 110233923
Obesity 84.78 10.23 48 196645 113303 110279303
Sputum increased 84.66 10.23 75 196618 5676 110386930
Ejection fraction 84.14 10.23 57 196636 2898 110389708
Polyp 83.81 10.23 96 196597 9884 110382722
Nail disorder 82.94 10.23 5 196688 57930 110334676
Mucous stools 82.78 10.23 80 196613 6767 110385839
Musculoskeletal pain 80.99 10.23 125 196568 182898 110209708
Neutrophil count decreased 79.85 10.23 59 196634 120882 110271724
Cushingoid 79.29 10.23 101 196592 11611 110380995
Ileal stenosis 78.92 10.23 57 196636 3213 110389393
Epstein-Barr viraemia 78.74 10.23 59 196634 3520 110389086
Sciatica 78.41 10.23 33 196660 92366 110300240
Stress 78.29 10.23 383 196310 104965 110287641
Prescribed overdose 78.06 10.23 29 196664 87552 110305054
Memory impairment 77.50 10.23 145 196548 196799 110195807
Vomiting 77.46 10.23 1147 195546 909528 109483078
Fibromyalgia 77.29 10.23 115 196578 170794 110221812
Discomfort 76.87 10.23 167 196526 214540 110178066
Sinus operation 76.47 10.23 54 196639 2937 110389669
Cytokine release syndrome 76.18 10.23 16 196677 70290 110322316
Gingival pain 75.52 10.23 115 196578 15621 110376985
Leukopenia 75.51 10.23 92 196601 148699 110243907
Pulmonary embolism 75.42 10.23 645 196048 213829 110178777
Upper respiratory tract infection 74.88 10.23 444 196249 130884 110261722
Blood calcium increased 74.39 10.23 123 196570 17917 110374689
Suicide attempt 74.20 10.23 46 196647 103348 110289258
Road traffic accident 74.05 10.23 50 196643 107348 110285258
Upper respiratory fungal infection 73.77 10.23 28 196665 399 110392207
Blood lactic acid increased 73.65 10.23 114 196579 15707 110376899
Ill-defined disorder 73.43 10.23 103 196590 156750 110235856
Lacrimation increased 73.42 10.23 167 196526 30783 110361823
Superinfection 72.83 10.23 69 196624 5694 110386912
Intestinal stenosis 72.44 10.23 63 196630 4652 110387954
Blepharospasm 72.14 10.23 7 196686 54844 110337762
Benign prostatic hyperplasia 72.09 10.23 122 196571 18112 110374494
Nipple swelling 72.09 10.23 27 196666 370 110392236
Labile blood pressure 71.16 10.23 48 196645 2423 110390183
Arteriosclerosis 69.46 10.23 143 196550 24624 110367982
Nasal obstruction 68.80 10.23 53 196640 3297 110389309
Colitis microscopic 68.73 10.23 101 196592 13293 110379313
Onychomadesis 68.34 10.23 3 196690 45660 110346946
Nephrectomy 68.28 10.23 48 196645 2592 110390014
Eosinophilic oesophagitis 67.59 10.23 37 196656 1275 110391331
Overdose 67.38 10.23 203 196490 233591 110159015
Drug specific antibody present 67.26 10.23 79 196614 8355 110384251
Rheumatoid arthritis 67.21 10.23 289 196404 299324 110093282
Live birth 67.19 10.23 20 196673 69464 110323142
Adrenal suppression 66.41 10.23 40 196653 1656 110390950
Liver disorder 65.99 10.23 94 196599 142149 110250457
Adjustment disorder with depressed mood 65.29 10.23 3 196690 43880 110348726
Gastrointestinal wall thickening 65.13 10.23 53 196640 3570 110389036
Salpingo-oophorectomy unilateral 64.82 10.23 31 196662 800 110391806
Taste disorder 64.74 10.23 18 196675 65369 110327237
Drug level decreased 64.13 10.23 117 196576 18431 110374175
Hip arthroplasty 64.09 10.23 11 196682 55802 110336804
Coma 64.01 10.23 69 196624 117800 110274806
Sedation 63.93 10.23 22 196671 69661 110322945
Drug intolerance 63.70 10.23 442 196251 406070 109986536
Neoplasm progression 63.55 10.23 18 196675 64577 110328029
Bone erosion 63.48 10.23 5 196688 46366 110346240
Peripheral swelling 63.46 10.23 439 196254 403595 109989011
Lung disorder 63.04 10.23 541 196152 179506 110213100
Cardio-respiratory arrest 62.70 10.23 68 196625 115768 110276838
Mucosal inflammation 62.05 10.23 48 196645 96093 110296513
Intestinal obstruction 61.92 10.23 222 196471 53005 110339601
Graft versus host disease in gastrointestinal tract 61.76 10.23 78 196615 8890 110383716
Ulcer 60.02 10.23 191 196502 42925 110349681
Illness 59.81 10.23 297 196396 81874 110310732
Respiratory distress 59.73 10.23 262 196431 68612 110323994
Hyper IgE syndrome 58.03 10.23 27 196666 654 110391952
Hypoxia 57.98 10.23 412 196281 129103 110263503
Abdominal discomfort 57.48 10.23 437 196256 393421 109999185
Epilepsy 57.44 10.23 56 196637 100153 110292453
Pulmonary function test decreased 57.29 10.23 74 196619 8626 110383980
Sinus disorder 57.01 10.23 157 196536 32571 110360035
Loss of therapeutic response 56.61 10.23 42 196651 2468 110390138
Micturition urgency 54.71 10.23 112 196581 19208 110373398
Coagulation factor deficiency 54.59 10.23 21 196672 311 110392295
Impaired work ability 54.48 10.23 135 196558 26284 110366322
Electrocardiogram QT prolonged 53.58 10.23 69 196624 108891 110283715
Bronchiolitis 53.31 10.23 57 196636 5436 110387170
Intestinal fistula 53.12 10.23 35 196658 1698 110390908
Cystic fibrosis 52.96 10.23 53 196640 4678 110387928
Eye pruritus 52.95 10.23 153 196540 32622 110359984
Aspergillus infection 52.94 10.23 131 196562 25485 110367121
Cushing's syndrome 52.87 10.23 28 196665 902 110391704
Nodule 52.41 10.23 152 196541 32479 110360127
Drug ineffective 52.25 10.23 3249 193444 1517291 108875315
Graft versus host disease 52.05 10.23 108 196585 18698 110373908
Lower limb fracture 52.05 10.23 35 196658 75313 110317293
Platelet count increased 51.62 10.23 132 196561 26202 110366404
Rhonchi 51.29 10.23 51 196642 4467 110388139
Peak expiratory flow rate decreased 51.24 10.23 25 196668 675 110391931
Capillaritis 50.99 10.23 39 196654 2400 110390206
Infection 50.45 10.23 407 196286 361793 110030813
Aphthous ulcer 50.08 10.23 114 196579 21022 110371584
Anosmia 50.04 10.23 84 196609 12388 110380218
Oropharyngeal pain 49.75 10.23 411 196282 134865 110257741
Ileal ulcer 49.25 10.23 34 196659 1783 110390823
Metabolic acidosis 49.21 10.23 63 196630 99681 110292925
Rheumatoid factor positive 49.11 10.23 100 196593 131540 110261066
Mechanical ventilation complication 48.95 10.23 25 196668 746 110391860
Secretion discharge 48.87 10.23 110 196583 20134 110372472
Aspiration 48.82 10.23 142 196551 30391 110362215
Exostosis 48.69 10.23 11 196682 45945 110346661
Muscular weakness 48.47 10.23 252 196441 248216 110144390
Inflammatory bowel disease 48.37 10.23 62 196631 7172 110385434
Tachypnoea 48.14 10.23 167 196526 39228 110353378
Scoliosis 47.95 10.23 68 196625 8665 110383941
Drug interaction 47.40 10.23 616 196077 499567 109893039
Dry mouth 47.22 10.23 189 196504 199759 110192847
Gait inability 47.22 10.23 108 196585 136268 110256338
Sopor 47.19 10.23 5 196688 36541 110356065
Nipple pain 47.18 10.23 28 196665 1128 110391478
Renal impairment 47.16 10.23 174 196519 188271 110204335
Hypoaesthesia 47.09 10.23 346 196347 313877 110078729
Bronchial obstruction 47.02 10.23 41 196652 3038 110389568
Vocal cord dysfunction 46.76 10.23 26 196667 924 110391682
Cytomegalovirus infection reactivation 45.81 10.23 101 196592 18232 110374374
Endometriosis 45.68 10.23 47 196646 4287 110388319
Faeces soft 45.64 10.23 76 196617 11134 110381472
Stenotrophomonas infection 45.27 10.23 54 196639 5804 110386802
Swollen tongue 45.23 10.23 220 196473 60142 110332464
Knee arthroplasty 45.09 10.23 30 196663 64918 110327688
Foot deformity 45.01 10.23 15 196678 48465 110344141
Asthma-chronic obstructive pulmonary disease overlap syndrome 45.00 10.23 56 196637 6288 110386318
Ejection fraction abnormal 44.82 10.23 42 196651 3418 110389188
Laryngeal stenosis 44.73 10.23 29 196664 1369 110391237
Infective pulmonary exacerbation of cystic fibrosis 44.66 10.23 88 196605 14683 110377923
Hepatic cytolysis 44.60 10.23 21 196672 55032 110337574
Ascites 44.38 10.23 60 196633 92748 110299858
Coagulation factor V level abnormal 44.22 10.23 15 196678 151 110392455
Granuloma skin 43.95 10.23 75 196618 11208 110381398
Pleuritic pain 43.87 10.23 92 196601 16048 110376558
Intentional self-injury 43.81 10.23 7 196686 37422 110355184
Rhabdomyolysis 43.62 10.23 93 196600 120308 110272298
Total lung capacity increased 42.63 10.23 49 196644 5063 110387543
Plasma cell myeloma 42.45 10.23 30 196663 62906 110329700
Asphyxia 42.15 10.23 84 196609 14131 110378475
Treatment failure 42.15 10.23 304 196389 276930 110115676
Depressed level of consciousness 42.13 10.23 85 196608 112193 110280413
Terminal ileitis 42.12 10.23 30 196663 1654 110390952
Oedema 42.06 10.23 211 196482 209765 110182841
Alcohol poisoning 41.99 10.23 65 196628 8955 110383651
Acute graft versus host disease 41.71 10.23 79 196614 12802 110379804
Onychomycosis 41.27 10.23 9 196684 38522 110354084
Ventricular failure 41.23 10.23 20 196673 533 110392073
Neurotoxicity 41.08 10.23 12 196681 42195 110350411
Tremor 40.83 10.23 544 196149 201688 110190918
Blood parathyroid hormone decreased 40.81 10.23 79 196614 13010 110379596
Back injury 40.09 10.23 17 196676 47382 110345224
Embolism venous 39.97 10.23 47 196646 4976 110387630
Cardiac arrest 39.81 10.23 197 196496 196556 110196050
Bronchitis 39.80 10.23 441 196252 156591 110236015
Factor V Leiden mutation 39.47 10.23 16 196677 274 110392332
Dysphonia 39.04 10.23 250 196443 75679 110316927
Rash 38.75 10.23 1138 195555 819826 109572780
Allergy to animal 38.66 10.23 30 196663 1886 110390720
Hepatic cirrhosis 38.51 10.23 38 196655 67588 110325018
Hyperkalaemia 38.33 10.23 119 196574 135677 110256929
Hepatorenal syndrome 38.23 10.23 44 196649 4553 110388053
Tumour lysis syndrome 37.82 10.23 5 196688 30796 110361810
Graft versus host disease in skin 37.76 10.23 59 196634 8195 110384411
Haemoglobin decreased 37.68 10.23 273 196420 248454 110144152
Pouchitis 37.53 10.23 26 196667 1371 110391235
Pancytopenia 37.37 10.23 219 196474 209394 110183212
Coeliac disease 37.32 10.23 15 196678 43172 110349434
Autoimmune disorder 37.06 10.23 37 196656 65446 110327160
Panniculitis 36.87 10.23 84 196609 15498 110377108
Tinnitus 36.65 10.23 208 196485 60332 110332274
Multiple sclerosis relapse 36.53 10.23 22 196671 50218 110342388
Emphysematous cholecystitis 36.37 10.23 12 196681 110 110392496
Skin necrosis 36.29 10.23 102 196591 21410 110371196
Atelectasis 35.99 10.23 145 196548 36567 110356039
Dyspnoea at rest 35.89 10.23 58 196635 8288 110384318
Butterfly rash 35.86 10.23 30 196663 2101 110390505
Abscess 35.81 10.23 119 196574 27350 110365256
Hepatic function abnormal 35.77 10.23 65 196628 89230 110303376
Aphonia 35.76 10.23 74 196619 12786 110379820
Sinus pain 35.61 10.23 48 196645 5831 110386775
Neuropathy peripheral 35.42 10.23 181 196512 179096 110213510
Hepatic ischaemia 35.31 10.23 24 196669 1227 110391379
Therapeutic response shortened 34.93 10.23 124 196569 29459 110363147
Bronchomalacia 34.83 10.23 15 196678 301 110392305
Underdose 34.73 10.23 37 196656 63517 110329089
Nausea 34.69 10.23 1821 194872 1233869 109158737
Lactic acidosis 34.19 10.23 71 196622 92740 110299866
Systemic mycosis 34.14 10.23 38 196655 3791 110388815
Bowel movement irregularity 33.99 10.23 54 196639 7606 110385000
Erythema nodosum 33.89 10.23 50 196643 6603 110386003
Use of accessory respiratory muscles 33.63 10.23 19 196674 697 110391909
Paraesthesia 33.51 10.23 322 196371 276199 110116407
Obstruction 33.38 10.23 46 196647 5706 110386900
Faecal calprotectin abnormal 33.19 10.23 15 196678 339 110392267
Nightmare 33.06 10.23 147 196546 38716 110353890
Cyanosis 32.86 10.23 122 196571 29619 110362987
Respiration abnormal 32.81 10.23 61 196632 9748 110382858
Cystitis haemorrhagic 32.49 10.23 69 196624 12140 110380466
Bradycardia 32.45 10.23 154 196539 155363 110237243
Myelodysplastic syndrome 32.42 10.23 13 196680 37471 110355135
Muscle relaxant therapy 32.34 10.23 12 196681 160 110392446
Blood iron decreased 32.31 10.23 91 196602 19123 110373483
Anaphylactic reaction 32.24 10.23 328 196365 113972 110278634
Dysarthria 32.14 10.23 63 196630 84058 110308548
Hiatus hernia 31.99 10.23 115 196578 27491 110365115
Restrictive pulmonary disease 31.95 10.23 34 196659 3225 110389381
Mental status changes 31.77 10.23 54 196639 76068 110316538
Acne 31.76 10.23 131 196562 33389 110359217
Increased bronchial secretion 31.51 10.23 37 196656 3911 110388695
Drug level above therapeutic 31.43 10.23 66 196627 11522 110381084
Osteoarthritis 31.39 10.23 193 196500 182430 110210176
Bone marrow failure 31.25 10.23 34 196659 57814 110334792
Finger deformity 31.14 10.23 10 196683 33082 110359524
Altered state of consciousness 30.99 10.23 34 196659 57592 110335014
Nasal discharge discolouration 30.68 10.23 33 196660 3168 110389438
Septic shock 30.57 10.23 160 196533 157368 110235238
Hyponatraemia 30.55 10.23 244 196449 217409 110175197
Carpal tunnel syndrome 30.41 10.23 99 196594 22511 110370095
Drug specific antibody 30.41 10.23 31 196662 2797 110389809
Cytomegalovirus colitis 30.27 10.23 49 196644 7012 110385594
Small intestinal resection 30.24 10.23 21 196672 1112 110391494
Drug reaction with eosinophilia and systemic symptoms 30.08 10.23 63 196630 82032 110310574
Terminal insomnia 29.98 10.23 26 196667 1912 110390694
Infusion related reaction 29.93 10.23 487 196206 380675 110011931
Delayed puberty 29.90 10.23 12 196681 200 110392406
Generalised oedema 29.89 10.23 121 196572 30583 110362023
Encephalopathy 29.86 10.23 62 196631 80993 110311613
Abscess intestinal 29.82 10.23 33 196660 3271 110389335
Status asthmaticus 29.80 10.23 20 196673 1001 110391605
Device expulsion 29.67 10.23 9 196684 30882 110361724
Exposure to allergen 29.29 10.23 16 196677 549 110392057
Diarrhoea haemorrhagic 29.22 10.23 77 196616 15562 110377044
Posterior reversible encephalopathy syndrome 28.87 10.23 12 196681 33849 110358757
Poisoning 28.83 10.23 8 196685 29097 110363509
Haemosiderosis 28.79 10.23 16 196677 568 110392038
Malignant mediastinal neoplasm 28.73 10.23 22 196671 1356 110391250
Ileocaecal resection 28.62 10.23 16 196677 575 110392031
Musculoskeletal stiffness 28.59 10.23 339 196354 279483 110113123
Viral infection 28.58 10.23 177 196516 52962 110339644
Hypoglycaemia 28.52 10.23 108 196585 115996 110276610
Contusion 28.16 10.23 272 196421 233089 110159517
Seasonal allergy 28.03 10.23 88 196605 19634 110372972
Large intestinal stenosis 27.83 10.23 34 196659 3746 110388860
Toxic epidermal necrolysis 27.81 10.23 36 196657 56691 110335915
Red blood cell sedimentation rate abnormal 27.77 10.23 5 196688 24504 110368102
Intentional device misuse 27.64 10.23 18 196675 856 110391750
Cardiogenic shock 27.48 10.23 37 196656 57301 110335305
Ventricular tachycardia 27.45 10.23 29 196664 49980 110342626
Dolichocolon 27.33 10.23 8 196685 47 110392559
Sinus congestion 27.27 10.23 117 196576 30342 110362264
Fistula 27.25 10.23 74 196619 15225 110377381
Lung diffusion test decreased 27.11 10.23 23 196670 1642 110390964
Abdominal pain upper 27.10 10.23 447 196246 348664 110043942
Clostridium difficile infection 27.02 10.23 172 196521 51957 110340649
Respiratory tract infection viral 26.86 10.23 42 196651 5836 110386770
Drug-induced liver injury 26.78 10.23 116 196577 119951 110272655
Psoriasis 26.72 10.23 143 196550 139850 110252756
Extrapyramidal disorder 26.68 10.23 9 196684 28858 110363748
Nonspecific reaction 26.54 10.23 30 196663 3044 110389562
Body temperature decreased 26.52 10.23 133 196560 36802 110355804
Uveitis 26.49 10.23 92 196601 21618 110370988
Metastases to liver 26.43 10.23 15 196678 35371 110357235
Frustration tolerance decreased 26.38 10.23 52 196641 8679 110383927
Miosis 25.98 10.23 4 196689 21979 110370627
Adrenal insufficiency 25.90 10.23 146 196547 42244 110350362
Smoke sensitivity 25.75 10.23 16 196677 701 110391905
Exposure during pregnancy 25.72 10.23 183 196510 167241 110225365
Agranulocytosis 25.60 10.23 44 196649 61716 110330890
Throat irritation 25.51 10.23 173 196520 53379 110339227
Sputum culture 25.37 10.23 12 196681 302 110392304
Inspiratory capacity decreased 25.31 10.23 27 196666 2568 110390038
Blood potassium decreased 25.30 10.23 174 196519 53940 110338666
Cognitive disorder 25.18 10.23 76 196617 87435 110305171
Injection site reaction 25.17 10.23 78 196615 88992 110303614
Respiratory tract infection bacterial 25.10 10.23 26 196667 2390 110390216
White coat hypertension 25.05 10.23 20 196673 1311 110391295
Lactobacillus infection 24.97 10.23 14 196679 506 110392100
Sedation complication 24.92 10.23 3 196690 19852 110372754
COVID-19 24.88 10.23 591 196102 244469 110148137
Mycobacterium test positive 24.80 10.23 15 196678 626 110391980
Type 2 diabetes mellitus 24.72 10.23 199 196494 177033 110215573
Poisoning deliberate 24.70 10.23 8 196685 26323 110366283
Serotonin syndrome 24.65 10.23 42 196651 59111 110333495
Product use in unapproved indication 24.57 10.23 1001 195692 446376 109946230
Sputum purulent 24.51 10.23 23 196670 1875 110390731
Asthenia 24.37 10.23 990 195703 688009 109704597
Poor venous access 24.16 10.23 97 196596 24425 110368181
Device delivery system issue 24.07 10.23 24 196669 2109 110390497
Hypothalamic pituitary adrenal axis suppression 23.94 10.23 15 196678 667 110391939
Retinitis viral 23.80 10.23 13 196680 446 110392160
Growth retardation 23.67 10.23 26 196667 2556 110390050
Dehydration 23.67 10.23 352 196341 279159 110113447
Herpes simplex oesophagitis 23.67 10.23 13 196680 451 110392155
Diabetic ketoacidosis 23.53 10.23 24 196669 42034 110350572
Headache 23.42 10.23 1847 194846 880530 109512076
Intentional product use issue 23.41 10.23 592 196101 247314 110145292
Increased upper airway secretion 23.38 10.23 37 196656 5195 110387411
Sepsis 23.19 10.23 426 196267 326920 110065686
Therapeutic product effect decreased 23.06 10.23 301 196392 244015 110148591
Hypoventilation 23.06 10.23 47 196646 8034 110384572
Hyperbilirubinaemia 22.91 10.23 13 196680 30658 110361948
Walking aid user 22.86 10.23 8 196685 25067 110367539
Transient ischaemic attack 22.77 10.23 193 196500 63789 110328817
Venous pressure jugular increased 22.68 10.23 19 196674 1333 110391273
Respiratory tract inflammation 22.52 10.23 17 196676 1026 110391580
Infective exacerbation of chronic obstructive airways disease 22.37 10.23 28 196665 3162 110389444
Palmar-plantar erythrodysaesthesia syndrome 22.29 10.23 24 196669 41001 110351605
Periumbilical abscess 22.21 10.23 11 196682 307 110392299
Acute myeloid leukaemia 22.18 10.23 21 196672 38089 110354517
Arthritis 22.14 10.23 420 196273 167166 110225440
Weight gain poor 22.08 10.23 19 196674 1383 110391223
Second primary malignancy 22.02 10.23 3 196690 18065 110374541
General physical health deterioration 21.94 10.23 582 196111 424713 109967893
Aural polyp 21.84 10.23 9 196684 161 110392445
Perfume sensitivity 21.84 10.23 17 196676 1074 110391532
Urinary tract infection 21.77 10.23 429 196264 325853 110066753
Flatulence 21.67 10.23 163 196530 51986 110340620
Cholestasis 21.60 10.23 52 196641 64466 110328140
Sensitivity to weather change 21.48 10.23 52 196641 9976 110382630
Acute graft versus host disease in intestine 21.33 10.23 37 196656 5602 110387004
Acute myocardial infarction 21.19 10.23 77 196616 83700 110308906
Respiratory arrest 21.14 10.23 45 196648 58254 110334352
Rectal tenesmus 21.12 10.23 23 196670 2239 110390367
Metastases to bone 21.10 10.23 15 196678 31357 110361249
Drug withdrawal syndrome 20.97 10.23 22 196671 38032 110354574
Orthostatic hypotension 20.94 10.23 55 196638 66194 110326412
Lupus-like syndrome 20.92 10.23 25 196668 40767 110351839
Ulcer haemorrhage 20.92 10.23 7 196686 22564 110370042
Joint dislocation 20.90 10.23 18 196675 34172 110358434
Iron deficiency anaemia 20.82 10.23 111 196582 31448 110361158
Pseudomonas infection 20.49 10.23 101 196592 27752 110364854
Akathisia 20.49 10.23 3 196690 17110 110375496
Dizziness 20.45 10.23 1024 195669 697169 109695437
Infection parasitic 20.26 10.23 15 196678 879 110391727
Large intestine polyp 20.16 10.23 66 196627 15051 110377555
Aplastic anaemia 20.11 10.23 9 196684 24299 110368307
Erythema 20.09 10.23 669 196024 290778 110101828
Gait disturbance 20.04 10.23 361 196332 277847 110114759
Procedural pneumothorax 20.01 10.23 8 196685 132 110392474
Respiratory syncytial virus infection 20.01 10.23 64 196629 14420 110378186
Gastrointestinal polyp 19.97 10.23 9 196684 202 110392404
Abdominal pain lower 19.93 10.23 124 196569 37159 110355447
Fluid retention 19.90 10.23 93 196600 94214 110298392
Short-bowel syndrome 19.82 10.23 14 196679 762 110391844
Creatinine renal clearance decreased 19.82 10.23 7 196686 21808 110370798
Pneumonia adenoviral 19.80 10.23 13 196680 627 110391979
Rheumatoid nodule 19.77 10.23 80 196613 20216 110372390
Pulmonary artery stenosis congenital 19.76 10.23 5 196688 15 110392591
Neck pain 19.69 10.23 133 196560 122997 110269609
Rash maculo-papular 19.58 10.23 67 196626 74155 110318451
Cytopenia 19.48 10.23 15 196678 30101 110362505
Oropharyngeal discomfort 19.45 10.23 51 196642 10276 110382330
Diarrhoea 19.42 10.23 1754 194939 1137751 109254855
Skin neoplasm excision 19.35 10.23 21 196672 2037 110390569
Botulism 19.33 10.23 12 196681 525 110392081
Hypersensitivity 19.01 10.23 560 196133 403438 109989168
Tubulointerstitial nephritis 18.92 10.23 163 196530 54121 110338485
Gastroenteritis adenovirus 18.88 10.23 11 196682 428 110392178
Loss of consciousness 18.84 10.23 241 196452 196065 110196541
Haemophagocytic lymphohistiocytosis 18.83 10.23 17 196676 31542 110361064
Anticoagulant therapy 18.76 10.23 34 196659 5327 110387279
Gastrointestinal mucosa hyperaemia 18.71 10.23 12 196681 556 110392050
Lung adenocarcinoma stage IV 18.65 10.23 12 196681 559 110392047
Cortisol decreased 18.48 10.23 24 196669 2812 110389794
Lip infection 18.37 10.23 8 196685 165 110392441
Apoptosis 18.31 10.23 13 196680 713 110391893
Osteonecrosis of jaw 18.31 10.23 36 196657 47981 110344625
Interstitial lung disease 18.28 10.23 159 196534 139175 110253431
Antacid therapy 18.21 10.23 34 196659 5450 110387156
Varicella zoster virus infection 18.13 10.23 37 196656 6331 110386275
Congenital anomaly 18.11 10.23 15 196678 1036 110391570
Leukoplakia oral 18.10 10.23 11 196682 463 110392143
Gastrointestinal inflammation 18.08 10.23 47 196646 9422 110383184
Rhinovirus infection 18.05 10.23 54 196639 11735 110380871
Secondary adrenocortical insufficiency 17.97 10.23 30 196663 4404 110388202
Amnesia 17.79 10.23 112 196581 105296 110287310
Incorrect dose administered 17.79 10.23 271 196422 103370 110289236
Respiratory rate increased 17.78 10.23 90 196603 24993 110367613
Herpes zoster meningoencephalitis 17.78 10.23 15 196678 1063 110391543
Sarcoidosis 17.76 10.23 56 196637 12523 110380083
Gastrointestinal disorder 17.72 10.23 313 196380 241639 110150967
Eye infection fungal 17.66 10.23 12 196681 613 110391993
Sinusitis 17.48 10.23 669 196024 296019 110096587
Oligoarthritis 17.46 10.23 13 196680 768 110391838
Transaminases increased 17.44 10.23 181 196512 63209 110329397
Serum ferritin decreased 17.34 10.23 24 196669 2990 110389616
Blood calcium decreased 17.31 10.23 23 196670 35822 110356784
Heart rate decreased 17.27 10.23 224 196469 82532 110310074
Device use issue 17.24 10.23 27 196666 3757 110388849
Haemorrhagic diathesis 17.24 10.23 40 196653 7468 110385138
Lymphopenia 17.22 10.23 28 196665 40142 110352464
Sprue-like enteropathy 17.17 10.23 18 196675 1678 110390928
Device difficult to use 17.14 10.23 6 196687 18799 110373807
Epstein-Barr virus infection reactivation 17.05 10.23 28 196665 4056 110388550
Liver function test abnormal 17.02 10.23 64 196629 68886 110323720
Tracheitis 16.95 10.23 18 196675 1703 110390903
Metastases to lung 16.91 10.23 10 196683 23053 110369553
Large intestine erosion 16.90 10.23 7 196686 127 110392479
Sinus polyp 16.89 10.23 12 196681 659 110391947
Paranasal sinus discomfort 16.82 10.23 36 196657 6369 110386237
Device dislocation 16.72 10.23 19 196674 31685 110360921
Sacroiliitis 16.70 10.23 31 196662 4947 110387659
Chronic graft versus host disease in intestine 16.59 10.23 12 196681 678 110391928
Eye swelling 16.49 10.23 108 196585 32940 110359666
Orthopnoea 16.42 10.23 50 196643 10971 110381635
Rectal abscess 16.31 10.23 22 196671 2674 110389932
Kyphosis 16.31 10.23 24 196669 3163 110389443
Respiratory tract haemorrhage 16.28 10.23 19 196674 1995 110390611
Myocardial infarction 16.22 10.23 242 196451 191841 110200765
Infrapatellar fat pad inflammation 16.16 10.23 8 196685 223 110392383
Anal fistula 16.12 10.23 42 196651 8431 110384175
Full blood count decreased 16.12 10.23 20 196673 32079 110360527
Myelosuppression 16.05 10.23 100 196593 94240 110298366
Disease recurrence 15.99 10.23 172 196521 60612 110331994
Ataxia 15.93 10.23 18 196675 30090 110362516
Pulseless electrical activity 15.88 10.23 5 196688 16752 110375854
Face oedema 15.87 10.23 108 196585 33361 110359245
Large intestinal ulcer 15.84 10.23 33 196660 5728 110386878
International normalised ratio increased 15.81 10.23 90 196603 86682 110305924
Red blood cell count decreased 15.75 10.23 62 196631 65861 110326745
Influenza 15.71 10.23 403 196290 168698 110223908
Breath holding 15.66 10.23 7 196686 154 110392452
Tracheal disorder 15.65 10.23 11 196682 594 110392012
Circumstance or information capable of leading to medication error 15.61 10.23 31 196662 5202 110387404
Pulmonary toxicity 15.60 10.23 6 196687 17740 110374866
Mitochondrial neurogastrointestinal encephalopathy 15.57 10.23 4 196689 13 110392593
Ligament pain 15.44 10.23 8 196685 246 110392360
Pertussis 15.43 10.23 15 196678 1278 110391328
Joint effusion 15.42 10.23 9 196684 20896 110371710
Generalised tonic-clonic seizure 15.37 10.23 48 196645 54632 110337974
Somnolence 15.34 10.23 407 196286 297042 110095564
Nephrotic syndrome 15.29 10.23 3 196690 13828 110378778
Dysgeusia 15.27 10.23 191 196502 69794 110322812
Acquired diaphragmatic eventration 15.25 10.23 12 196681 770 110391836
Proctalgia 15.25 10.23 55 196638 13167 110379439
Oedema mouth 15.20 10.23 23 196670 3107 110389499
Bacterial toxaemia 15.14 10.23 7 196686 167 110392439
Anaemia 15.12 10.23 807 195886 546279 109846327
Cerebral infarction 14.93 10.23 45 196648 51793 110340813
Right ventricular systolic pressure 14.93 10.23 4 196689 16 110392590
Faecal calprotectin decreased 14.84 10.23 6 196687 102 110392504
Anal abscess 14.80 10.23 50 196643 11588 110381018
Disorientation 14.73 10.23 70 196623 70601 110322005
Penile erythema 14.66 10.23 7 196686 180 110392426
Anuria 14.66 10.23 13 196680 24328 110368278
Paranoia 14.65 10.23 11 196682 22363 110370243
Cardiac failure congestive 14.63 10.23 185 196508 150815 110241791
Candida infection 14.62 10.23 140 196553 47869 110344737
Haemorrhage intracranial 14.60 10.23 18 196675 28951 110363655
Neutropenic sepsis 14.57 10.23 20 196673 30726 110361880
Adenoviral hepatitis 14.50 10.23 13 196680 999 110391607
Drug use disorder 14.48 10.23 7 196686 18067 110374539
Renal failure 14.48 10.23 300 196393 226274 110166332
Gastrointestinal stenosis 14.47 10.23 9 196684 395 110392211
Joint injury 14.42 10.23 121 196572 39873 110352733
Vaccination site pain 14.41 10.23 10 196683 529 110392077
Joint stiffness 14.37 10.23 66 196627 67177 110325429
Bronchial disorder 14.34 10.23 21 196672 2755 110389851
Gastrointestinal bacterial infection 14.27 10.23 15 196678 1403 110391203
Renal tubular necrosis 14.27 10.23 20 196673 30455 110362151
Anamnestic reaction 14.10 10.23 5 196688 58 110392548
Throat tightness 14.10 10.23 105 196588 33384 110359222
Adrenocortical insufficiency acute 14.09 10.23 27 196666 4413 110388193
Hypocalcaemia 14.06 10.23 64 196629 65302 110327304
Immunodeficiency 14.06 10.23 30 196663 38808 110353798
Drug hypersensitivity 14.06 10.23 662 196031 453428 109939178
Activated partial thromboplastin time shortened 14.02 10.23 13 196680 1044 110391562
Herpes simplex colitis 14.00 10.23 6 196687 119 110392487
Brain oedema 13.98 10.23 21 196672 31077 110361529
Jaundice 13.97 10.23 56 196637 59180 110333426
Stridor 13.97 10.23 35 196658 6860 110385746
Laryngeal cryptococcosis 13.93 10.23 3 196690 3 110392603
Pharyngeal oedema 13.87 10.23 62 196631 16366 110376240
Abnormal faeces 13.86 10.23 42 196651 9194 110383412
Blood pressure systolic increased 13.86 10.23 216 196477 82775 110309831
Intestinal resection 13.86 10.23 25 196668 3904 110388702
Lower respiratory tract congestion 13.81 10.23 28 196665 4768 110387838
Gamma-glutamyltransferase increased 13.81 10.23 59 196634 61250 110331356
Cytomegalovirus enteritis 13.80 10.23 13 196680 1065 110391541
Viral haemorrhagic cystitis 13.78 10.23 23 196670 3376 110389230
Analgesic therapy 13.75 10.23 36 196657 7248 110385358
Personality disorder 13.74 10.23 3 196690 12834 110379772
Anastomotic ulcer 13.72 10.23 13 196680 1073 110391533
Shock 13.72 10.23 49 196644 53539 110339067
Iron overload 13.70 10.23 18 196675 2133 110390473
Precancerous condition 13.70 10.23 10 196683 573 110392033
Ileostomy 13.69 10.23 19 196674 2373 110390233
Oxygen saturation decreased 13.69 10.23 371 196322 156611 110235995
Febrile bone marrow aplasia 13.63 10.23 7 196686 17458 110375148
Toxic encephalopathy 13.62 10.23 5 196688 15209 110377397
Hypercholesterolaemia 13.60 10.23 100 196593 90737 110301869
Gangrene 13.60 10.23 6 196687 16335 110376271
Pain 13.60 10.23 1489 195204 953466 109439140
Suspected suicide 13.60 10.23 5 196688 15194 110377412
Rubber sensitivity 13.53 10.23 19 196674 2399 110390207
Haematocrit decreased 13.48 10.23 66 196627 66051 110326555
Immune reconstitution inflammatory syndrome 13.44 10.23 6 196687 16220 110376386
Dysphoria 13.42 10.23 33 196660 6395 110386211
Nasal septum deviation 13.40 10.23 18 196675 2180 110390426
Enterococcal infection 13.35 10.23 10 196683 20356 110372250
Blood immunoglobulin E decreased 13.32 10.23 7 196686 222 110392384
Stevens-Johnson syndrome 13.30 10.23 41 196652 46860 110345746
Laryngeal oedema 13.24 10.23 43 196650 9764 110382842
Ischaemic stroke 13.23 10.23 34 196659 41229 110351377
Blood alkaline phosphatase increased 13.23 10.23 73 196620 70862 110321744
Respiratory syncytial virus bronchiolitis 13.23 10.23 11 196682 764 110391842
Hysterectomy 13.22 10.23 38 196655 8076 110384530
Hyperplastic cholecystopathy 13.20 10.23 7 196686 226 110392380
Foetal death 13.18 10.23 6 196687 16039 110376567
Sleep disorder therapy 13.17 10.23 36 196657 7435 110385171
Cryptosporidiosis infection 13.15 10.23 13 196680 1130 110391476
Periorbital oedema 13.15 10.23 44 196649 10148 110382458
Dyschezia 13.14 10.23 24 196669 3783 110388823
Abdominal abscess 13.13 10.23 40 196653 8779 110383827
Otorrhoea 13.08 10.23 18 196675 2230 110390376
Product substitution error 13.06 10.23 5 196688 73 110392533
Blood pressure diastolic abnormal 13.05 10.23 16 196677 25799 110366807
Myositis 13.05 10.23 22 196671 31094 110361512
Immune effector cell-associated neurotoxicity syndrome 12.99 10.23 5 196688 14777 110377829
Atrioventricular block complete 12.99 10.23 10 196683 20072 110372534
Coronary artery disease 12.90 10.23 189 196504 71501 110321105
Drug resistance 12.85 10.23 54 196639 56320 110336286
Pneumococcal infection 12.81 10.23 16 196677 1803 110390803
Laryngitis 12.81 10.23 36 196657 42375 110350231
Neutrophilia 12.80 10.23 44 196649 10285 110382321
Dermatitis contact 12.80 10.23 54 196639 13899 110378707
Small airways disease 12.76 10.23 5 196688 78 110392528
Diabetes mellitus 12.76 10.23 248 196445 99133 110293473
Swelling face 12.75 10.23 233 196460 92088 110300518
Cytomegalovirus duodenitis 12.72 10.23 6 196687 150 110392456
Hemiparesis 12.72 10.23 38 196655 43865 110348741
Drug therapy 12.72 10.23 35 196658 7256 110385350
Humidity intolerance 12.72 10.23 9 196684 491 110392115
Congenital hydronephrosis 12.72 10.23 3 196690 6 110392600
Bronchitis bacterial 12.69 10.23 16 196677 1820 110390786
Allergic respiratory disease 12.68 10.23 6 196687 151 110392455
Rectal prolapse 12.68 10.23 19 196674 2544 110390062
Transplant rejection 12.66 10.23 15 196678 24552 110368054
Diverticulum 12.66 10.23 58 196635 15468 110377138
Osteomyelitis 12.65 10.23 29 196664 36571 110356035
C-reactive protein increased 12.64 10.23 293 196400 217626 110174980
Cerebral haemorrhage 12.59 10.23 66 196627 64902 110327704
Respiratory tract congestion 12.57 10.23 96 196597 30761 110361845
Product residue present 12.55 10.23 24 196669 3917 110388689
Tracheostomy infection 12.54 10.23 6 196687 155 110392451
Disseminated intravascular coagulation 12.50 10.23 35 196658 41251 110351355
Infusion site reaction 12.50 10.23 8 196685 17674 110374932
Hospitalisation 12.49 10.23 337 196356 142156 110250450
Subarachnoid haemorrhage 12.46 10.23 21 196672 29681 110362925
Distal intestinal obstruction syndrome 12.44 10.23 12 196681 1013 110391593
Hallucination, visual 12.42 10.23 33 196660 39572 110353034
Hepatitis cholestatic 12.35 10.23 8 196685 17558 110375048
Ageusia 12.22 10.23 68 196625 19577 110373029
Respiratory depression 12.20 10.23 24 196669 31977 110360629
Hypogammaglobulinaemia 12.16 10.23 69 196624 20007 110372599
Electrocardiogram QRS complex prolonged 12.14 10.23 4 196689 13017 110379589
Adrenal cortex necrosis 12.09 10.23 4 196689 37 110392569
Pneumatosis intestinalis 12.07 10.23 38 196655 8491 110384115
Cytomegalovirus infection 12.05 10.23 149 196544 54295 110338311
Nephropathy toxic 12.05 10.23 87 196606 27391 110365215
Tenosynovitis 12.02 10.23 7 196686 16276 110376330
Bacterial infection 11.98 10.23 130 196563 45906 110346700
Hypoaesthesia eye 11.98 10.23 8 196685 397 110392209
Balance disorder 11.97 10.23 141 196552 116419 110276187
Colectomy 11.95 10.23 25 196668 4353 110388253
Skin atrophy 11.94 10.23 32 196661 6532 110386074
Thrombosis 11.93 10.23 265 196428 108397 110284209
Gastroenteritis clostridial 11.93 10.23 12 196681 1066 110391540
Sinusitis bacterial 11.92 10.23 18 196675 2426 110390180
Hypomagnesaemia 11.89 10.23 61 196632 60309 110332297
Pharyngitis streptococcal 11.89 10.23 51 196642 13226 110379380
Skin striae 11.88 10.23 17 196676 2184 110390422
Post viral fatigue syndrome 11.86 10.23 7 196686 279 110392327
Paranasal sinus mucosal hypertrophy 11.86 10.23 5 196688 95 110392511
Tracheobronchitis 11.85 10.23 19 196674 2697 110389909
Seizure 11.84 10.23 301 196392 220884 110171722
Hypokalaemia 11.82 10.23 241 196452 182207 110210399
Vocal cord disorder 11.82 10.23 15 196678 1718 110390888
Anal incontinence 11.71 10.23 73 196620 21891 110370715
Blood lactate dehydrogenase increased 11.71 10.23 40 196653 44294 110348312
Normal newborn 11.68 10.23 13 196680 21883 110370723
Small intestinal stenosis 11.65 10.23 13 196680 1300 110391306
Effusion 11.64 10.23 19 196674 2738 110389868
Paranasal sinus hyposecretion 11.60 10.23 6 196687 184 110392422
Product administered to patient of inappropriate age 11.55 10.23 36 196657 8000 110384606
Abdominal adhesions 11.52 10.23 24 196669 4166 110388440
Gastroenteritis norovirus 11.51 10.23 22 196671 3589 110389017
Diffuse large B-cell lymphoma 11.50 10.23 7 196686 15891 110376715
Acute respiratory distress syndrome 11.50 10.23 52 196641 53146 110339460
Oropharyngeal candidiasis 11.46 10.23 16 196677 2010 110390596
Atrioventricular block 11.44 10.23 8 196685 16869 110375737
Granuloma 11.39 10.23 40 196653 9450 110383156
Coordination abnormal 11.37 10.23 17 196676 25211 110367395
Polyneuropathy 11.36 10.23 25 196668 31987 110360619
Fungal oesophagitis 11.36 10.23 12 196681 1129 110391477
Nasal disorder 11.35 10.23 24 196669 4210 110388396
Enthesopathy 11.34 10.23 4 196689 12474 110380132
Hydronephrosis 11.32 10.23 12 196681 20653 110371953
Tooth discolouration 11.26 10.23 13 196680 1350 110391256
Cardiac failure 11.24 10.23 251 196442 187375 110205231
Bronchitis viral 11.20 10.23 13 196680 1358 110391248
Red blood cell agglutination 11.19 10.23 3 196690 12 110392594
No adverse event 11.19 10.23 81 196612 73758 110318848
Peripheral sensory neuropathy 11.18 10.23 8 196685 16672 110375934
Enterocutaneous fistula 11.18 10.23 17 196676 2306 110390300
Pathogen resistance 11.18 10.23 9 196684 17663 110374943
Axillary pain 11.16 10.23 18 196675 2568 110390038
Blood glucose increased 11.16 10.23 167 196526 132329 110260277
Myalgia 11.16 10.23 493 196200 221888 110170718
Bulimia nervosa 11.14 10.23 7 196686 313 110392293
Dystonia 11.05 10.23 18 196675 25787 110366819
Blood immunoglobulin E 11.01 10.23 4 196689 50 110392556
Device ineffective 11.01 10.23 6 196687 205 110392401
Diplopia 10.93 10.23 38 196655 41856 110350750
Blood triglycerides increased 10.91 10.23 16 196677 23910 110368696
Night sweats 10.90 10.23 170 196523 133813 110258793
Lethargy 10.89 10.23 110 196583 93466 110299140
Pneumonia viral 10.88 10.23 44 196649 11113 110381493
Bone disorder 10.86 10.23 13 196680 21179 110371427
Left ventricular hypertrophy 10.81 10.23 5 196688 13239 110379367
Pneumothorax 10.79 10.23 103 196590 35182 110357424
Electrolyte imbalance 10.79 10.23 107 196586 36921 110355685
Tracheal haemorrhage 10.77 10.23 10 196683 804 110391802
Retinal ischaemia 10.76 10.23 11 196682 996 110391610
Stoma site abscess 10.75 10.23 7 196686 333 110392273
Bronchospasm paradoxical 10.75 10.23 6 196687 215 110392391
Pharyngeal hypoaesthesia 10.67 10.23 8 196685 478 110392128
Nail dystrophy 10.63 10.23 12 196681 1216 110391390
Gastrointestinal haemorrhage 10.62 10.23 219 196474 165299 110227307
Hemiplegia 10.62 10.23 15 196678 22767 110369839
Coprolalia 10.60 10.23 4 196689 56 110392550
Anti-saccharomyces cerevisiae antibody test positive 10.60 10.23 4 196689 56 110392550
Choking sensation 10.59 10.23 24 196669 4412 110388194
Type IV hypersensitivity reaction 10.56 10.23 29 196664 6004 110386602
Campylobacter gastroenteritis 10.56 10.23 15 196678 1914 110390692
Haemolytic anaemia 10.54 10.23 13 196680 20907 110371699
Pneumonia aspiration 10.52 10.23 93 196600 81140 110311466
Oral hairy leukoplakia 10.49 10.23 3 196690 16 110392590
Rib deformity 10.47 10.23 6 196687 226 110392380
Hyperglycaemia 10.47 10.23 211 196482 84879 110307727
Skin warm 10.45 10.23 38 196655 9132 110383474
Oropharyngitis fungal 10.43 10.23 6 196687 228 110392378
Enteritis 10.42 10.23 64 196629 19092 110373514
Cholangitis sclerosing 10.42 10.23 21 196672 3561 110389045
Metastases to lymph nodes 10.36 10.23 7 196686 15025 110377581
Skin dystrophy 10.35 10.23 4 196689 60 110392546
Haematuria 10.32 10.23 96 196597 82909 110309697
Hypertransaminasaemia 10.31 10.23 17 196676 24238 110368368
Labelled drug-drug interaction medication error 10.31 10.23 23 196670 29279 110363327
Eye allergy 10.30 10.23 11 196682 1048 110391558
Hypercapnic coma 10.25 10.23 8 196685 507 110392099

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A07EA06 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
INTESTINAL ANTIINFLAMMATORY AGENTS
Corticosteroids acting locally
ATC D07AC09 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, potent (group III)
ATC R01AD05 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R03AK07 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK12 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK15 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AL11 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03BA02 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
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:50857 anti-allergic agent
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:77715 nasal decongestant
CHEBI has role CHEBI:88188 drug allergen
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D001993 Bronchodilator Agents
MeSH PA D005938 Glucocorticoids
MeSH PA D006728 Hormones
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D019141 Respiratory System Agents

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D07AC Corticosteroids, potent (group III) 20 drugs
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R01AD Corticosteroids 12 drugs
beclometasone dipropionatebetamethasoneciclesonidedexamethasoneflunisolidefluticasone furoatefluticasone propionatehydrocortisonemometasone furoateprednisolonetixocortoltriamcinolone
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R03BA Glucocorticoids 8 drugs
beclometasone dipropionatebetamethasoneciclesonideflunisolidefluticasone furoatefluticasone propionatemometasone furoatetriamcinolone

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

DiseaseRelationSNOMED_IDDOID
Crohn's disease indication 34000006
Allergic rhinitis indication 61582004
Ulcerative colitis indication 64766004 DOID:8577
Primary immunoglobulin A nephropathy indication 68779003
Asthma indication 195967001 DOID:2841
Eosinophilic esophagitis indication 235599003 DOID:13922
Severe chronic obstructive pulmonary disease indication 313299006
Asthma management indication 406162001
Crohn's disease in remission indication 426549001
Chronic Non-Allergic Rhinitis indication
Allergic Rhinitis Prevention indication
Infection by Strongyloides contraindication 1214006 DOID:10955
Mycosis contraindication 3218000 DOID:1564
Ocular hypertension contraindication 4210003 DOID:9282
Gastritis contraindication 4556007 DOID:4029
Inactive tuberculosis contraindication 11999007
Epistaxis contraindication 12441001
Peptic ulcer contraindication 13200003 DOID:750
Hypercholesterolemia contraindication 13644009
Measles contraindication 14189004 DOID:8622
Disease caused by parasite contraindication 17322007
Cirrhosis of liver contraindication 19943007 DOID:5082
Arginase deficiency contraindication 23501004 DOID:9278
Glaucoma contraindication 23986001 DOID:1686
Acute tuberculosis contraindication 25629007
Viral disease contraindication 34014006 DOID:934
Immunosuppression contraindication 38013005
Hypertensive disorder contraindication 38341003 DOID:10763
Infectious disease contraindication 40733004
Hypothyroidism contraindication 40930008 DOID:1459
Hypokalemia contraindication 43339004
Hypercortisolism contraindication 47270006
Chronic heart failure contraindication 48447003
Cerebral malaria contraindication 53622003 DOID:14069
Tuberculosis contraindication 56717001
Congenital hyperammonemia, type I contraindication 62522004
Osteoporosis contraindication 64859006 DOID:11476
Psychotic disorder contraindication 69322001
Diabetes mellitus contraindication 73211009 DOID:9351
Hypopituitarism contraindication 74728003 DOID:9406
Perforation of nasal septum contraindication 80142000
Hyperglycemia contraindication 80394007 DOID:4195
Ornithine Carbamyltransferase Deficiency contraindication 80908008 DOID:9271
Open-angle glaucoma contraindication 84494001 DOID:1067
Bacterial infectious disease contraindication 87628006
Muscle atrophy contraindication 88092000 DOID:767
Herpes simplex contraindication 88594005 DOID:8566
Operation on nose contraindication 88733004
Bilateral cataracts contraindication 95722004
Seizure disorder contraindication 128613002
Disorder of muscle contraindication 129565002 DOID:423
Pulmonary tuberculosis contraindication 154283005 DOID:2957
Ophthalmic herpes simplex contraindication 186542001
Anastomosis of intestine contraindication 235407009
Disease of liver contraindication 235856003 DOID:409
Edema contraindication 267038008
Pathological fracture contraindication 268029009
Diverticulitis of gastrointestinal tract contraindication 271366000
Cerebral trauma contraindication 275382005
Varicella-zoster virus infection contraindication 309465005
Osteopenia contraindication 312894000
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Avascular necrosis of bone contraindication 397758007 DOID:10159
Citrullinemia contraindication 398680004 DOID:9273
Traumatic rupture of tendon contraindication 415749005
Exposure to varicella contraindication 444453009
Severe hepatic impairment contraindication 710067001
Nasal Candidiasis contraindication
Untreated Fungal Infection contraindication
Uncontrolled Bacterial Infections contraindication
Nasal Trauma contraindication
Arginosuccinate Lyase Deficiency contraindication
Oropharyngeal Candidiasis contraindication
Nasal Septal Ulcers contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.8 acidic
pKa2 12.78 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
2MG/10ML EOHILIA TAKEDA PHARMS USA N213976 Feb. 9, 2024 RX SUSPENSION ORAL 8497258 Nov. 9, 2026 TREATMENT OF EOSINOPHILIC ESOPHAGITIS
2MG/10ML EOHILIA TAKEDA PHARMS USA N213976 Feb. 9, 2024 RX SUSPENSION ORAL 8975243 Nov. 9, 2026 TREATMENT OF EOSINOPHILIC ESOPHAGITIS
2MG/10ML EOHILIA TAKEDA PHARMS USA N213976 Feb. 9, 2024 RX SUSPENSION ORAL 9119863 Nov. 9, 2026 TREATMENT OF EOSINOPHILIC ESOPHAGITIS
2MG/10ML EOHILIA TAKEDA PHARMS USA N213976 Feb. 9, 2024 RX SUSPENSION ORAL 11357859 Nov. 12, 2028 TREATMENT OF EOSINOPHILIC ESOPHAGITIS
4MG TARPEYO CALLIDITAS N215935 Dec. 15, 2021 RX CAPSULE, DELAYED RELEASE ORAL 8491932 May 7, 2029 REDUCTION IN LOSS OF KIDNEY FUNCTION IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK OF DISEASE PROGRESSION
4MG TARPEYO CALLIDITAS N215935 Dec. 15, 2021 RX CAPSULE, DELAYED RELEASE ORAL 8491932 May 7, 2029 TREATMENT OF PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) IN ADULTS AT RISK OF RAPID DISEASE PROGRESSION
2MG/10ML EOHILIA TAKEDA PHARMS USA N213976 Feb. 9, 2024 RX SUSPENSION ORAL 8324192 Aug. 3, 2029 TREATMENT OF EOSINOPHILIC ESOPHAGITIS
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 10716753 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 8324266 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 8703806 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 8808713 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 9463161 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 10716753 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 8324266 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 8703806 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 8808713 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 9463161 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
EQ 0.09MG BASE/INH;0.08MG/INH AIRSUPRA ASTRAZENECA N214070 Jan. 10, 2023 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 AS-NEEDED TREATMENT OR PREVENTION OF BRONCHOCONSTRICTION AND REDUCTION OF THE RISK OF EXACERBATIONS IN PATIENTS WITH ASTHMA 18 YEARS OF AGE AND OLDER
0.08MG/INH;0.0048MG/INH SYMBICORT AEROSPHERE ASTRAZENECA N216579 April 27, 2026 RX AEROSOL, METERED INHALATION 10716753 May 28, 2030 TREATMENT OF ASTHMA IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER
0.08MG/INH;0.0048MG/INH SYMBICORT AEROSPHERE ASTRAZENECA N216579 April 27, 2026 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 TREATMENT OF ASTHMA IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER
0.16MG/INH;0.0048MG/INH SYMBICORT AEROSPHERE ASTRAZENECA N216579 April 28, 2023 RX AEROSOL, METERED INHALATION 10716753 May 28, 2030 MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH SYMBICORT AEROSPHERE ASTRAZENECA N216579 April 28, 2023 RX AEROSOL, METERED INHALATION 10716753 May 28, 2030 TREATMENT OF ASTHMA IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER
0.16MG/INH;0.0048MG/INH SYMBICORT AEROSPHERE ASTRAZENECA N216579 April 28, 2023 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH SYMBICORT AEROSPHERE ASTRAZENECA N216579 April 28, 2023 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 TREATMENT OF ASTHMA IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 8815258 March 17, 2031 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 8815258 March 17, 2031 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
9MG UCERIS SALIX N203634 Jan. 14, 2013 RX TABLET, EXTENDED RELEASE ORAL 9192581 Sept. 7, 2031 INDUCTION OF REMISSION IN PATIENTS WITH ACTIVE, MILD TO MODERATE ULCERATIVE COLITIS
6MG ORTIKOS SUN PHARM INDS INC N211929 June 13, 2019 DISCN CAPSULE, DELAYED RELEASE ORAL 10172802 Sept. 9, 2036 TREATMENT OF MILD TO MODERATE ACTIVE CROHNS DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON
6MG ORTIKOS SUN PHARM INDS INC N211929 June 13, 2019 DISCN CAPSULE, DELAYED RELEASE ORAL 9707182 Sept. 9, 2036 TREATMENT OF MILD TO MODERATE ACTIVE CROHNS DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON
9MG ORTIKOS SUN PHARM INDS INC N211929 June 13, 2019 DISCN CAPSULE, DELAYED RELEASE ORAL 10172802 Sept. 9, 2036 TREATMENT OF MILD TO MODERATE ACTIVE CROHNS DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON
9MG ORTIKOS SUN PHARM INDS INC N211929 June 13, 2019 DISCN CAPSULE, DELAYED RELEASE ORAL 9707182 Sept. 9, 2036 TREATMENT OF MILD TO MODERATE ACTIVE CROHNS DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON
2MG/10ML EOHILIA TAKEDA PHARMS USA N213976 Feb. 9, 2024 RX SUSPENSION ORAL 11564934 Jan. 10, 2039 TREATMENT OF EOSINOPHILIC ESOPHAGITIS
4MG TARPEYO CALLIDITAS N215935 Dec. 15, 2021 RX CAPSULE, DELAYED RELEASE ORAL 11896719 Jan. 23, 2043 REDUCTION IN LOSS OF KIDNEY FUNCTION AND REDUCTION OF PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK OF DISEASE PROGRESSION, BY RELEASE OF BUDESONIDE FROM THE FORMULATION
4MG TARPEYO CALLIDITAS N215935 Dec. 15, 2021 RX CAPSULE, DELAYED RELEASE ORAL 12171882 Jan. 23, 2043 REDUCTION IN LOSS OF KIDNEY FUNCTION IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK OF DISEASE PROGRESSION, BY RELEASE OF BUDESONIDE FROM THE FORMULATION
4MG TARPEYO CALLIDITAS N215935 Dec. 15, 2021 RX CAPSULE, DELAYED RELEASE ORAL 12171882 Jan. 23, 2043 REDUCTION OF PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK OF DISEASE PROGRESSION, BY RELEASE OF BUDESONIDE FROM THE FORMULATION
4MG TARPEYO CALLIDITAS N215935 Dec. 15, 2021 RX CAPSULE, DELAYED RELEASE ORAL 12311057 Jan. 23, 2043 REDUCTION IN LOSS OF KIDNEY FUNCTION IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK OF DISEASE PROGRESSION, BY RELEASE OF BUDESONIDE FROM THE FORMULATION
4MG TARPEYO CALLIDITAS N215935 Dec. 15, 2021 RX CAPSULE, DELAYED RELEASE ORAL 12311057 Jan. 23, 2043 REDUCTION OF PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK OF DISEASE PROGRESSION, BY RELEASE OF BUDESONIDE FROM THE FORMULATION
4MG TARPEYO CALLIDITAS N215935 Dec. 15, 2021 RX CAPSULE, DELAYED RELEASE ORAL 12311057 Jan. 23, 2043 TREATMENT OF PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) IN ADULTS AT RISK OF RAPID DISEASE PROGRESSION, BY RELEASE OF BUDESONIDE FROM THE FORMULATION

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 0.09MG BASE/INH;0.08MG/INH AIRSUPRA ASTRAZENECA N214070 Jan. 10, 2023 RX AEROSOL, METERED INHALATION Jan. 10, 2026 NEW PRODUCT
2MG/10ML EOHILIA TAKEDA PHARMS USA N213976 Feb. 9, 2024 RX SUSPENSION ORAL Feb. 9, 2027 NEW PRODUCT
EQ 0.09MG BASE/INH;0.08MG/INH AIRSUPRA ASTRAZENECA N214070 Jan. 10, 2023 RX AEROSOL, METERED INHALATION Sept. 15, 2028 LABELING REVISIONS TO REFLECT THE RESULTS OF BATURA STUDY
4MG TARPEYO CALLIDITAS N215935 Dec. 15, 2021 RX CAPSULE, DELAYED RELEASE ORAL Dec. 15, 2028 TO REDUCE PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) AT RISK OF RAPID DISEASE PROGRESSION, GENERALLY A URINE PROTEIN-TO-CREATININE RATIO (UPCR) > OR = 1.5 G/G
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION April 27, 2029 NEW STRENGTH
0.08MG/INH;0.0048MG/INH SYMBICORT AEROSPHERE ASTRAZENECA N216579 April 27, 2026 RX AEROSOL, METERED INHALATION April 27, 2029 NEW STRENGTH
0.16MG/INH;0.0048MG/INH SYMBICORT AEROSPHERE ASTRAZENECA N216579 April 28, 2023 RX AEROSOL, METERED INHALATION April 27, 2029 TREATMENT OF ASTHMA IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER
4MG TARPEYO CALLIDITAS N215935 Dec. 15, 2021 RX CAPSULE, DELAYED RELEASE ORAL Dec. 20, 2030 TO REDUCE THE LOSS OF KIDNEY FUNCTION IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK FOR DISEASE PROGRESSION, EXCLUDING THE USE PROVIDED FOR IN THE INDICATION APPROVED ON DECEMBER 15, 2021
2MG/10ML EOHILIA TAKEDA PHARMS USA N213976 Feb. 9, 2024 RX SUSPENSION ORAL Feb. 9, 2031 TREATMENT OF ADULT AND PEDIATRIC PATIENTS 11 YEARS OF AGE AND OLDER WITH EOSINOPHILIC ESOPHAGITIS (EOE)

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST EC50 10.30 WOMBAT-PK CHEMBL
Interleukin-5 Cytokine IC50 9.92 WOMBAT-PK
Interferon gamma Cytokine IC50 9.50 WOMBAT-PK
Mineralocorticoid receptor Nuclear hormone receptor AGONIST EC50 7.85 IUPHAR
Progesterone receptor Nuclear hormone receptor AGONIST EC50 7.55 IUPHAR
Matrix metalloproteinase-9 Enzyme IC50 5.70 DRUG MATRIX
Multidrug resistance protein 1 Transporter WOMBAT-PK
Androgen receptor Transcription factor Ki 5.96 DRUG MATRIX
Progesterone receptor Transcription factor Ki 7.57 DRUG MATRIX
Glucocorticoid receptor Transcription factor IC50 8.54 CHEMBL
Interleukin-5 Cytokine IC50 4.58 CHEMBL
Interleukin-5 receptor subunit alpha Membrane receptor IC50 4.58 CHEMBL

External reference:

IDSource
4020889 VUID
N0000148384 NUI
D00246 KEGG_DRUG
19831 RXNORM
C0054201 UMLSCUI
CHEBI:3207 CHEBI
CHEMBL1370 ChEMBL_ID
D019819 MESH_DESCRIPTOR_UI
DB01222 DRUGBANK_ID
5281004 PUBCHEM_CID
7434 IUPHAR_LIGAND_ID
4145 INN_ID
Q3OKS62Q6X UNII
4303 MMSL
44092 MMSL
d04276 MMSL
108622005 SNOMEDCT_US
395726003 SNOMEDCT_US
4020889 VANDF
004214 NDDF
Q3OKS62Q6X INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-6815 SUSPENSION 0.25 mg RESPIRATORY (INHALATION) ANDA 26 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-6815 SUSPENSION 0.25 mg RESPIRATORY (INHALATION) ANDA 26 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-6816 SUSPENSION 0.50 mg RESPIRATORY (INHALATION) ANDA 26 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-6816 SUSPENSION 0.50 mg RESPIRATORY (INHALATION) ANDA 26 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-6817 SUSPENSION 1 mg RESPIRATORY (INHALATION) ANDA 26 sections
Budesonide Inhalation HUMAN PRESCRIPTION DRUG LABEL 1 0115-1687 SUSPENSION 0.25 mg RESPIRATORY (INHALATION) ANDA 25 sections
Budesonide Inhalation HUMAN PRESCRIPTION DRUG LABEL 1 0115-1689 SUSPENSION 0.50 mg RESPIRATORY (INHALATION) ANDA 25 sections
SYMBICORT HUMAN PRESCRIPTION DRUG LABEL 2 0186-0370 AEROSOL 160 ug RESPIRATORY (INHALATION) NDA 28 sections
SYMBICORT HUMAN PRESCRIPTION DRUG LABEL 2 0186-0372 AEROSOL 80 ug RESPIRATORY (INHALATION) NDA 28 sections
PULMICORTFLEXHALER HUMAN PRESCRIPTION DRUG LABEL 1 0186-0916 AEROSOL, POWDER 180 ug RESPIRATORY (INHALATION) NDA 25 sections
PULMICORTFLEXHALER HUMAN PRESCRIPTION DRUG LABEL 1 0186-0917 AEROSOL, POWDER 90 ug RESPIRATORY (INHALATION) NDA 25 sections
PULMICORT RESPULES HUMAN PRESCRIPTION DRUG LABEL 1 0186-1988 SUSPENSION 0.25 mg RESPIRATORY (INHALATION) NDA 25 sections
PULMICORT RESPULES HUMAN PRESCRIPTION DRUG LABEL 1 0186-1989 SUSPENSION 0.50 mg RESPIRATORY (INHALATION) NDA 25 sections
PULMICORT RESPULES HUMAN PRESCRIPTION DRUG LABEL 1 0186-1990 SUSPENSION 1 mg RESPIRATORY (INHALATION) NDA 25 sections
BREZTRI HUMAN PRESCRIPTION DRUG LABEL 3 0310-4616 AEROSOL, METERED 160 ug RESPIRATORY (INHALATION) NDA 28 sections
BREZTRI HUMAN PRESCRIPTION DRUG LABEL 3 0310-6616 AEROSOL, METERED 160 ug RESPIRATORY (INHALATION) NDA 28 sections
Budesonide and Formoterol Fumarate Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0310-7370 AEROSOL 160 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
Budesonide and Formoterol Fumarate Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0310-7372 AEROSOL 80 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
AIRSUPRA HUMAN PRESCRIPTION DRUG LABEL 2 0310-9080 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 30 sections
Budesonide HUMAN OTC DRUG LABEL 1 0363-0048 SPRAY, METERED 32 ug NASAL ANDA 15 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0378-4500 TABLET, FILM COATED, EXTENDED RELEASE 9 mg ORAL ANDA 29 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0378-4500 TABLET, FILM COATED, EXTENDED RELEASE 9 mg ORAL ANDA 29 sections
BREYNA HUMAN PRESCRIPTION DRUG LABEL 2 0378-7502 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) ANDA 30 sections
BREYNA HUMAN PRESCRIPTION DRUG LABEL 2 0378-7502 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) ANDA 30 sections
BREYNA HUMAN PRESCRIPTION DRUG LABEL 2 0378-7503 AEROSOL, METERED 160 ug RESPIRATORY (INHALATION) ANDA 30 sections
BREYNA HUMAN PRESCRIPTION DRUG LABEL 2 0378-7503 AEROSOL, METERED 160 ug RESPIRATORY (INHALATION) ANDA 30 sections
Budesonide and formoterol fumarate dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0480-3080 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) ANDA 28 sections
Budesonide and formoterol fumarate dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0480-3081 AEROSOL, METERED 160 ug RESPIRATORY (INHALATION) ANDA 28 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0487-9601 INHALANT 0.25 mg RESPIRATORY (INHALATION) ANDA 27 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0487-9701 INHALANT 0.50 mg RESPIRATORY (INHALATION) ANDA 27 sections