budesonide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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
2 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

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 2302.36 10.42 1823 105097 125738 63256364
Wheezing 988.88 10.42 999 105921 94596 63287506
Obstructive airways disorder 772.83 10.42 464 106456 20235 63361867
Dyspnoea 667.50 10.42 2528 104392 658785 62723317
Full blood count abnormal 567.46 10.42 452 106468 31265 63350837
Sleep disorder due to a general medical condition 538.99 10.42 305 106615 11883 63370219
Cough 445.86 10.42 1289 105631 291454 63090648
Macular degeneration 362.19 10.42 312 106608 24064 63358038
Chest discomfort 354.85 10.42 652 106268 109317 63272785
Chronic sinusitis 273.34 10.42 203 106717 12640 63369462
Eosinophil count increased 272.09 10.42 190 106730 10738 63371364
Upper-airway cough syndrome 244.17 10.42 181 106739 11237 63370865
Hand deformity 236.33 10.42 7 106913 159450 63222652
Colitis ulcerative 234.04 10.42 253 106667 25838 63356264
Nasal polyps 226.92 10.42 136 106784 5903 63376199
Alopecia 226.18 10.42 145 106775 337391 63044711
Loss of personal independence in daily activities 225.59 10.42 503 106417 96787 63285315
Contraindicated product administered 221.43 10.42 48 106872 217600 63164502
Bronchial secretion retention 217.27 10.42 102 106818 2671 63379431
Systemic lupus erythematosus 214.73 10.42 45 106875 208873 63173229
Glossodynia 211.90 10.42 26 106894 178850 63203252
Eosinophilic bronchitis 205.43 10.42 64 106856 509 63381593
Gastrooesophageal reflux disease 183.17 10.42 459 106461 95180 63286922
Toxicity to various agents 181.49 10.42 95 106825 247155 63134947
Blood test abnormal 175.41 10.42 171 106749 15458 63366644
Rhinitis allergic 173.96 10.42 150 106770 11577 63370525
Completed suicide 172.94 10.42 21 106899 145652 63236450
Pericarditis 171.93 10.42 13 106907 131566 63250536
Therapeutic product effect incomplete 167.45 10.42 527 106393 124529 63257573
Productive cough 162.71 10.42 341 106579 62867 63319235
Swelling 160.20 10.42 137 106783 275241 63106861
Respiratory symptom 156.75 10.42 87 106833 3260 63378842
Arthropathy 155.61 10.42 102 106818 234690 63147412
Sputum discoloured 152.73 10.42 162 106758 16185 63365917
Eosinophilia 151.02 10.42 189 106731 22567 63359535
Polycystic ovaries 150.87 10.42 94 106826 4377 63377725
Chronic obstructive pulmonary disease 150.78 10.42 329 106591 62357 63319745
Reversible airways obstruction 148.16 10.42 69 106851 1773 63380329
Frequent bowel movements 146.11 10.42 187 106733 22835 63359267
Breath sounds abnormal 146.07 10.42 132 106788 10841 63371261
Blood immunoglobulin E increased 142.85 10.42 86 106834 3763 63378339
Helicobacter infection 141.51 10.42 3 106917 92782 63289320
Pneumonia 140.22 10.42 1276 105644 455491 62926611
Nasal congestion 131.89 10.42 321 106599 65339 63316763
Wound 131.67 10.42 55 106865 163208 63218894
Asthmatic crisis 130.77 10.42 63 106857 1750 63380352
Vital capacity decreased 130.58 10.42 62 106858 1666 63380436
Sleep apnoea syndrome 126.02 10.42 197 106723 28936 63353166
Synovitis 125.45 10.42 80 106840 186838 63195264
Abdominal discomfort 124.98 10.42 218 106702 320667 63061435
Bronchospasm 121.88 10.42 148 106772 17132 63364970
Sensitisation 116.30 10.42 72 106848 3314 63378788
Middle insomnia 114.07 10.42 123 106797 12520 63369582
Bronchiectasis 113.44 10.42 138 106782 16004 63366098
Febrile neutropenia 112.78 10.42 30 106890 118419 63263683
Polyp 110.33 10.42 90 106830 6431 63375671
Joint swelling 109.14 10.42 244 106676 327422 63054680
Sputum culture positive 108.86 10.42 59 106861 2108 63379994
Treatment failure 108.57 10.42 105 106815 198938 63183164
Forced expiratory volume decreased 106.76 10.42 79 106841 4889 63377213
Pulmonary function test abnormal 103.72 10.42 54 106866 1776 63380326
Growth failure 101.46 10.42 33 106887 306 63381796
Impaired healing 101.43 10.42 24 106896 102518 63279584
Lung diffusion test abnormal 101.08 10.42 33 106887 310 63381792
Folliculitis 100.93 10.42 4 106916 70313 63311789
Ejection fraction 100.42 10.42 58 106862 2348 63379754
Impaired quality of life 98.76 10.42 119 106801 13664 63368438
Heart rate increased 92.94 10.42 359 106561 93879 63288223
Respiratory tract infection 91.08 10.42 210 106710 41273 63340829
Labile blood pressure 90.68 10.42 49 106871 1740 63380362
Rheumatoid arthritis 89.48 10.42 183 106737 253636 63128466
Discomfort 89.30 10.42 90 106830 167284 63214818
Bacterial disease carrier 89.24 10.42 44 106876 1287 63380815
Therapeutic reaction time decreased 88.07 10.42 53 106867 2317 63379785
Ear pruritus 87.34 10.42 64 106856 3901 63378201
Hepatic enzyme increased 85.68 10.42 130 106790 202198 63179904
Neutrophilia 85.68 10.42 66 106854 4340 63377762
Female genital tract fistula 85.37 10.42 83 106837 7476 63374626
White blood cell count decreased 84.79 10.42 66 106854 139038 63243064
Rhinorrhoea 84.63 10.42 273 106647 65304 63316798
Superinfection 83.42 10.42 53 106867 2554 63379548
Stomatitis 83.07 10.42 67 106853 138658 63243444
Blister 81.16 10.42 60 106860 129754 63252348
Psoriatic arthropathy 80.17 10.42 27 106893 91493 63290609
Neutropenia 79.47 10.42 107 106813 174898 63207204
Sinusitis fungal 78.72 10.42 45 106875 1786 63380316
Dyspnoea exertional 75.98 10.42 249 106671 60053 63322049
Drug intolerance 75.90 10.42 266 106654 308395 63073707
Hypothyroidism 75.75 10.42 199 106721 42433 63339669
Pain 75.59 10.42 841 106079 739787 62642315
Sinus disorder 74.59 10.42 142 106778 24411 63357691
Intentional overdose 74.03 10.42 17 106903 74135 63307967
Eosinophilic granulomatosis with polyangiitis 73.74 10.42 46 106874 2146 63379956
Weight decreased 72.73 10.42 749 106171 276049 63106053
Blood cholesterol increased 72.12 10.42 34 106886 93998 63288104
Thrombocytopenia 70.08 10.42 91 106829 151066 63231036
Sputum increased 68.90 10.42 46 106874 2413 63379689
Haematochezia 68.27 10.42 222 106698 53322 63328780
Vocal cord dysfunction 68.04 10.42 28 106892 529 63381573
Drug abuse 67.82 10.42 19 106901 72499 63309603
Salpingo-oophorectomy unilateral 67.77 10.42 32 106888 849 63381253
Therapeutic product effect decreased 67.45 10.42 140 106780 193047 63189055
Hyper IgE syndrome 66.96 10.42 27 106893 483 63381619
Death 66.86 10.42 364 106556 374017 63008085
Paraesthesia oral 65.59 10.42 117 106803 19139 63362963
Eczema 64.95 10.42 158 106762 32133 63349969
Chest X-ray abnormal 63.07 10.42 56 106864 4493 63377609
Embolism venous 62.98 10.42 48 106872 3106 63378996
Liver injury 62.19 10.42 13 106907 60507 63321595
Malignant neoplasm progression 60.99 10.42 31 106889 82090 63300012
Platelet count decreased 60.15 10.42 64 106856 116058 63266044
Acute kidney injury 60.14 10.42 234 106686 263181 63118921
Pulmonary mass 59.39 10.42 123 106797 22473 63359629
Off label use 58.78 10.42 1518 105402 672944 62709158
Dysphonia 57.65 10.42 194 106726 47420 63334682
Abdominal pain 57.36 10.42 750 106170 292706 63089396
Mobility decreased 57.12 10.42 72 106848 121087 63261015
Total lung capacity decreased 56.79 10.42 39 106881 2144 63379958
Pancytopenia 56.55 10.42 48 106872 96885 63285217
Hip arthroplasty 56.19 10.42 7 106913 47639 63334463
Upper respiratory fungal infection 56.01 10.42 18 106902 160 63381942
Blood pressure increased 54.81 10.42 463 106457 161599 63220503
Peripheral swelling 54.66 10.42 246 106674 265696 63116406
Emphysema 54.46 10.42 79 106841 10859 63371243
Irritable bowel syndrome 54.26 10.42 36 106884 82376 63299726
Faecal calprotectin increased 53.75 10.42 44 106876 3159 63378943
Anaphylactic reaction 51.98 10.42 235 106685 65865 63316237
Peak expiratory flow rate decreased 51.95 10.42 24 106896 605 63381497
Bronchitis 51.67 10.42 374 106546 124561 63257541
Rash 51.28 10.42 652 106268 560219 62821883
Graft versus host disease in gastrointestinal tract 51.22 10.42 43 106877 3198 63378904
Maternal exposure during pregnancy 50.53 10.42 195 106725 219867 63162235
Laryngeal stenosis 50.42 10.42 28 106892 1050 63381052
Multiple allergies 49.78 10.42 86 106834 13716 63368386
Rhinitis 49.34 10.42 77 106843 11289 63370813
Ventricular failure 49.28 10.42 20 106900 364 63381738
C-reactive protein abnormal 49.26 10.42 9 106911 46087 63336015
Intestinal stenosis 49.20 10.42 40 106880 2844 63379258
Bronchopulmonary aspergillosis allergic 48.73 10.42 36 106884 2222 63379880
Catarrh 48.34 10.42 31 106889 1518 63380584
Hepatic ischaemia 47.67 10.42 23 106897 641 63381461
Confusional state 47.17 10.42 221 106699 236159 63145943
Procedural pain 47.13 10.42 109 106811 21460 63360642
Hypotension 46.47 10.42 269 106651 272335 63109767
Defaecation urgency 45.57 10.42 45 106875 4130 63377972
Sinusitis 44.97 10.42 581 106339 226072 63156030
Sinus operation 44.40 10.42 36 106884 2550 63379552
Restrictive pulmonary disease 44.19 10.42 31 106889 1764 63380338
Vomiting 43.50 10.42 672 106248 558945 62823157
Circumstance or information capable of leading to medication error 42.78 10.42 42 106878 3828 63378274
Steroid dependence 42.35 10.42 30 106890 1734 63380368
Pulmonary function test decreased 42.08 10.42 42 106878 3905 63378197
Fall 42.06 10.42 440 106480 391894 62990208
Bacterial infection 42.01 10.42 98 106822 19401 63362701
Sneezing 41.95 10.42 94 106826 18124 63363978
Inappropriate schedule of product administration 41.70 10.42 309 106611 103656 63278446
Drug level below therapeutic 41.56 10.42 46 106874 4820 63377282
Decreased appetite 41.05 10.42 251 106669 250801 63131301
Intentional device misuse 40.59 10.42 22 106898 786 63381316
Dust allergy 40.55 10.42 21 106899 683 63381419
Fatigue 39.57 10.42 1167 105753 886861 62495241
Disease progression 39.50 10.42 93 106827 122665 63259437
Bronchial obstruction 39.38 10.42 27 106893 1480 63380622
Ileal stenosis 38.53 10.42 28 106892 1685 63380417
Throat clearing 38.04 10.42 32 106888 2387 63379715
Blood lactic acid increased 37.96 10.42 53 106867 7033 63375069
Gastrointestinal disorder 37.93 10.42 105 106815 131134 63250968
Hepatorenal syndrome 37.70 10.42 29 106891 1903 63380199
Butterfly rash 37.66 10.42 28 106892 1745 63380357
Drug specific antibody present 37.65 10.42 41 106879 4218 63377884
Palpitations 36.95 10.42 320 106600 112450 63269652
Rales 36.81 10.42 72 106848 12625 63369477
Throat irritation 36.74 10.42 143 106777 37504 63344598
Drug specific antibody 36.71 10.42 31 106889 2324 63379778
Arthritis enteropathic 36.42 10.42 15 106905 284 63381818
Rheumatoid factor positive 35.92 10.42 54 106866 84352 63297750
Infective pulmonary exacerbation of cystic fibrosis 35.89 10.42 58 106862 8759 63373343
Upper respiratory tract infection 35.88 10.42 249 106671 81798 63300304
Bulimia nervosa 35.80 10.42 17 106903 457 63381645
Intestinal obstruction 35.74 10.42 124 106796 30775 63351327
Sleep disorder due to general medical condition, insomnia type 35.48 10.42 22 106898 52195 63329907
Ejection fraction abnormal 35.28 10.42 27 106893 1758 63380344
Vaginal flatulence 35.03 10.42 35 106885 3258 63378844
Systemic mycosis 35.01 10.42 23 106897 1174 63380928
Nephrectomy 34.71 10.42 25 106895 1483 63380619
Oropharyngeal pain 34.64 10.42 275 106645 94212 63287890
Aspergillus infection 33.98 10.42 54 106866 8039 63374063
Illness 33.18 10.42 167 106753 48892 63333210
Device expulsion 32.93 10.42 9 106911 34913 63347189
Neutrophil count decreased 32.81 10.42 28 106892 56378 63325724
Adrenal suppression 32.63 10.42 20 106900 904 63381198
Venous pressure jugular increased 32.63 10.42 17 106903 560 63381542
Diastolic dysfunction 32.60 10.42 47 106873 6424 63375678
Muscle relaxant therapy 32.51 10.42 12 106908 167 63381935
Lung opacity 32.47 10.42 33 106887 3135 63378967
Nausea 32.26 10.42 1147 105773 853324 62528778
Oropharyngeal discomfort 32.23 10.42 42 106878 5218 63376884
Multiple sclerosis relapse 32.14 10.42 21 106899 48457 63333645
Haemoptysis 32.12 10.42 114 106806 28612 63353490
Cognitive disorder 32.11 10.42 28 106892 55787 63326315
Respiratory tract inflammation 31.89 10.42 17 106903 587 63381515
Neoplasm progression 31.45 10.42 11 106909 36417 63345685
Knee arthroplasty 31.42 10.42 27 106893 54179 63327923
Sedation 31.38 10.42 13 106907 38796 63343306
Graft versus host disease in skin 31.13 10.42 31 106889 2874 63379228
Lung disorder 30.26 10.42 194 106726 62067 63320035
Carpal tunnel syndrome 29.93 10.42 90 106830 20727 63361375
Frustration tolerance decreased 29.86 10.42 47 106873 6941 63375161
Overdose 29.71 10.42 97 106823 114981 63267121
Infection 29.70 10.42 245 106675 228928 63153174
Cystic fibrosis 29.61 10.42 32 106888 3264 63378838
Proctitis 29.60 10.42 41 106879 5400 63376702
Bronchomalacia 29.49 10.42 12 106908 220 63381882
Condition aggravated 28.93 10.42 884 106036 401333 62980769
Malignant mediastinal neoplasm 28.86 10.42 22 106898 1424 63380678
Bone marrow failure 28.67 10.42 7 106913 29283 63352819
Lacrimation increased 28.54 10.42 88 106832 20543 63361559
Herpes simplex oesophagitis 28.52 10.42 11 106909 174 63381928
Prescribed overdose 28.33 10.42 11 106909 34142 63347960
Secretion discharge 28.04 10.42 63 106857 12168 63369934
Diarrhoea 27.94 10.42 956 105964 714410 62667692
Ascites 27.89 10.42 17 106903 40711 63341391
Intentional self-injury 27.48 10.42 5 106915 25682 63356420
Obstruction 27.47 10.42 30 106890 3097 63379005
Injury 27.33 10.42 51 106869 73196 63308906
Endometriosis 27.33 10.42 39 106881 5281 63376821
Gastrointestinal wall thickening 27.23 10.42 21 106899 1383 63380719
Hiatus hernia 27.03 10.42 89 106831 21505 63360597
Infective exacerbation of chronic obstructive airways disease 27.03 10.42 20 106900 1237 63380865
Cushingoid 26.92 10.42 50 106870 8435 63373667
Cardio-respiratory arrest 26.85 10.42 37 106883 59922 63322180
Rhonchi 26.71 10.42 27 106893 2549 63379553
Anal fissure 26.48 10.42 35 106885 4408 63377694
Cardiac disorder 25.72 10.42 160 106760 50656 63331446
Scoliosis 25.68 10.42 47 106873 7841 63374261
Nonspecific reaction 25.57 10.42 25 106895 2267 63379835
Drug level decreased 25.55 10.42 47 106873 7872 63374230
Status asthmaticus 25.54 10.42 17 106903 887 63381215
Diverticulum 25.54 10.42 60 106860 11931 63370171
Musculoskeletal stiffness 25.48 10.42 194 106726 184424 63197678
Eye pruritus 25.23 10.42 79 106841 18592 63363510
Rectal haemorrhage 25.21 10.42 155 106765 48875 63333227
Aspiration 24.99 10.42 56 106864 10795 63371307
Suicide attempt 24.93 10.42 40 106880 60878 63321224
Colitis microscopic 24.73 10.42 51 106869 9288 63372814
Eosinophilic oesophagitis 24.72 10.42 12 106908 339 63381763
Atelectasis 24.66 10.42 86 106834 21397 63360705
Swollen tongue 24.62 10.42 120 106800 34680 63347422
Leukopenia 24.50 10.42 59 106861 77231 63304871
Sputum culture 24.35 10.42 11 106909 263 63381839
Asphyxia 24.26 10.42 40 106880 6141 63375961
Sinus pain 23.71 10.42 29 106891 3381 63378721
Device malfunction 23.62 10.42 75 106845 17782 63364320
Pouchitis 23.25 10.42 13 106907 494 63381608
Coma 22.98 10.42 46 106874 64318 63317784
Burns second degree 22.86 10.42 22 106898 1956 63380146
Intestinal resection 22.75 10.42 26 106894 2822 63379280
Sputum purulent 22.72 10.42 17 106903 1070 63381032
Somnolence 22.70 10.42 192 106728 178493 63203609
Anosmia 22.49 10.42 41 106879 6819 63375283
Metastases to liver 22.46 10.42 6 106914 23633 63358469
Malaise 22.33 10.42 884 106036 415070 62967032
Hyperglycaemia 21.93 10.42 133 106787 41734 63340368
Oligoarthritis 21.82 10.42 13 106907 558 63381544
Viral infection 21.77 10.42 118 106802 35545 63346557
Mucous stools 21.61 10.42 31 106889 4217 63377885
Encephalopathy 21.46 10.42 20 106900 38600 63343502
Nasal obstruction 21.43 10.42 20 106900 1711 63380391
Candida infection 20.95 10.42 99 106821 28252 63353850
Sensitivity to weather change 20.93 10.42 41 106879 7196 63374906
Red blood cell sedimentation rate abnormal 20.84 10.42 4 106916 19778 63362324
Lip infection 20.83 10.42 8 106912 125 63381977
Adrenal insufficiency 20.81 10.42 72 106848 17843 63364259
Hepatotoxicity 20.80 10.42 19 106901 37022 63345080
Therapeutic response shortened 20.61 10.42 55 106865 11833 63370269
Respiration abnormal 20.59 10.42 38 106882 6379 63375723
Pseudomonas infection 20.59 10.42 53 106867 11160 63370942
Osteomyelitis 20.58 10.42 9 106911 26011 63356091
Respiratory distress 20.50 10.42 112 106808 33839 63348263
Colitis 20.46 10.42 146 106774 48382 63333720
Human herpesvirus 6 infection 20.32 10.42 25 106895 2932 63379170
Nasal discharge discolouration 20.32 10.42 22 106898 2249 63379853
Haemoglobin decreased 20.01 10.42 153 106767 145332 63236770
Pharyngeal hypoaesthesia 19.99 10.42 10 106910 302 63381800
Aphonia 19.98 10.42 49 106871 10014 63372088
Infusion related reaction 19.97 10.42 292 106628 245229 63136873
Periorbital oedema 19.95 10.42 35 106885 5649 63376453
Bone erosion 19.95 10.42 3 106917 17714 63364388
Bronchial wall thickening 19.88 10.42 18 106902 1481 63380621
Hypopnoea 19.70 10.42 28 106892 3778 63378324
Crohn's disease 19.56 10.42 32 106888 4881 63377221
Increased bronchial secretion 19.21 10.42 19 106901 1747 63380355
Depressed level of consciousness 19.20 10.42 48 106872 62030 63320072
Small intestinal stenosis 19.06 10.42 12 106908 569 63381533
Alternaria infection 18.95 10.42 9 106911 242 63381860
Smoke sensitivity 18.83 10.42 11 106909 455 63381647
Mitochondrial neurogastrointestinal encephalopathy 18.79 10.42 4 106916 4 63382098
Hyponatraemia 18.72 10.42 111 106809 111789 63270313
Sprue-like enteropathy 18.68 10.42 13 106907 730 63381372
Gastroenteritis adenovirus 18.68 10.42 9 106911 250 63381852
Hysterectomy 18.59 10.42 46 106874 9453 63372649
Renal impairment 18.56 10.42 81 106839 88274 63293828
Bursitis 18.53 10.42 21 106899 37020 63345082
Weight gain poor 18.42 10.42 14 106906 902 63381200
Device delivery system issue 18.28 10.42 13 106907 756 63381346
Clostridium difficile infection 18.26 10.42 99 106821 29823 63352279
Anal fistula 18.19 10.42 26 106894 3525 63378577
Pulmonary fibrosis 18.10 10.42 122 106798 39687 63342415
Graft versus host disease 17.99 10.42 37 106883 6726 63375376
Dyslipidaemia 17.98 10.42 39 106881 7354 63374748
Disease recurrence 17.96 10.42 94 106826 27936 63354166
Bowel movement irregularity 17.94 10.42 32 106888 5232 63376870
Tracheostomy infection 17.86 10.42 5 106915 26 63382076
Sciatica 17.67 10.42 19 106901 34305 63347797
Tremor 17.67 10.42 317 106603 131922 63250180
Skin lesion 17.65 10.42 100 106820 30621 63351481
Type IV hypersensitivity reaction 17.54 10.42 23 106897 2875 63379227
Increased upper airway secretion 17.53 10.42 26 106894 3646 63378456
Oesophageal candidiasis 17.50 10.42 33 106887 5630 63376472
Aggression 17.33 10.42 82 106838 23416 63358686
Red blood cell count decreased 17.29 10.42 26 106894 40619 63341483
Distal intestinal obstruction syndrome 17.24 10.42 10 106910 408 63381694
Oral candidiasis 17.13 10.42 80 106840 22718 63359384
Obstructive pancreatitis 17.13 10.42 10 106910 413 63381689
Metastases to bone 17.06 10.42 7 106913 21012 63361090
Ligament pain 16.98 10.42 8 106912 211 63381891
Electrocardiogram QT prolonged 16.91 10.42 48 106872 59482 63322620
Abscess 16.82 10.42 64 106856 16604 63365498
Rectal tenesmus 16.79 10.42 13 106907 861 63381241
Stress 16.76 10.42 180 106740 66987 63315115
Underdose 16.75 10.42 13 106907 27443 63354659
Kyphosis 16.69 10.42 21 106899 2519 63379583
Allergy to animal 16.60 10.42 15 106905 1231 63380871
Acquired diaphragmatic eventration 16.52 10.42 10 106910 442 63381660
Myelodysplastic syndrome 16.40 10.42 4 106916 16750 63365352
Throat tightness 16.32 10.42 84 106836 24803 63357299
Anaemia 16.31 10.42 373 106547 293057 63089045
Female reproductive neoplasm 16.25 10.42 5 106915 38 63382064
Plasma cell myeloma 16.23 10.42 22 106898 35883 63346219
Cytomegalovirus colitis 16.21 10.42 20 106900 2352 63379750
Diabetes mellitus 16.05 10.42 154 106766 55656 63326446
Blood calcium increased 15.95 10.42 43 106877 9307 63372795
Hypercholesterolaemia 15.92 10.42 8 106912 21326 63360776
Infusion site extravasation 15.87 10.42 46 106874 10380 63371722
Hypocalcaemia 15.84 10.42 18 106902 31695 63350407
Eosinophil count decreased 15.84 10.42 19 106901 2171 63379931
Pharyngeal oedema 15.81 10.42 55 106865 13666 63368436
Creatinine renal clearance decreased 15.76 10.42 4 106916 16304 63365798
Terminal insomnia 15.74 10.42 12 106908 777 63381325
Rectal prolapse 15.66 10.42 18 106902 1965 63380137
Blood immunoglobulin G decreased 15.64 10.42 20 106900 2438 63379664
Respiratory disorder 15.57 10.42 116 106804 38966 63343136
Renal disorder 15.56 10.42 102 106818 32872 63349230
Joint range of motion decreased 15.56 10.42 19 106901 32409 63349693
Mucosal inflammation 15.53 10.42 35 106885 46893 63335209
Tachypnoea 15.50 10.42 64 106856 17238 63364864
Dyspnoea at rest 15.48 10.42 26 106894 4053 63378049
Bradycardia 15.46 10.42 67 106853 73160 63308942
Toxic epidermal necrolysis 15.45 10.42 12 106908 25322 63356780
Metabolic acidosis 15.42 10.42 33 106887 45036 63337066
Abdominal rigidity 15.36 10.42 18 106902 2006 63380096
Eczema impetiginous 15.35 10.42 4 106916 15 63382087
Hyperkalaemia 15.18 10.42 44 106876 54159 63327943
Abscess intestinal 15.08 10.42 16 106904 1598 63380504
Ulcer 15.01 10.42 85 106835 26022 63356080
Delayed puberty 15 10.42 6 106914 105 63381997
Nocturnal dyspnoea 14.88 10.42 14 106906 1210 63380892
Drug level above therapeutic 14.85 10.42 28 106892 4777 63377325
Otorrhoea 14.77 10.42 15 106905 1424 63380678
Cortisol decreased 14.69 10.42 14 106906 1230 63380872
Weight fluctuation 14.63 10.42 43 106877 9776 63372326
Drug interaction 14.56 10.42 285 106635 228846 63153256
Aspirin-exacerbated respiratory disease 14.40 10.42 12 106908 883 63381219
COVID-19 14.36 10.42 269 106651 112834 63269268
Post viral fatigue syndrome 14.19 10.42 8 106912 309 63381793
Delirium 14.18 10.42 41 106879 50500 63331602
Incorrect dose administered 14.17 10.42 159 106761 59809 63322293
Cryptosporidiosis infection 14.14 10.42 8 106912 311 63381791
Terminal ileitis 14.12 10.42 11 106909 735 63381367
Radiculopathy 14.09 10.42 39 106881 8572 63373530
Drug withdrawal syndrome 14.06 10.42 15 106905 27179 63354923
Blood glucose increased 14.05 10.42 83 106837 83673 63298429
Liver disorder 14.03 10.42 45 106875 53642 63328460
Coprolalia 13.95 10.42 4 106916 23 63382079
Sinus congestion 13.92 10.42 64 106856 18059 63364043
Myalgia 13.90 10.42 334 106586 146195 63235907
Exposure to allergen 13.89 10.42 8 106912 322 63381780
Growth retardation 13.80 10.42 14 106906 1327 63380775
Foot deformity 13.70 10.42 16 106904 27837 63354265
Musculoskeletal pain 13.67 10.42 95 106825 92182 63289920
Burning sensation 13.66 10.42 146 106774 54261 63327841
Loss of consciousness 13.65 10.42 130 106790 117991 63264111
Body temperature decreased 13.62 10.42 69 106851 20250 63361852
Poor venous access 13.49 10.42 55 106865 14730 63367372
Device dislocation 13.49 10.42 14 106906 25691 63356411
Hypertension 13.46 10.42 587 106333 278716 63103386
Vaginal discharge 13.44 10.42 40 106880 9158 63372944
Gastrointestinal scarring 13.37 10.42 8 106912 346 63381756
Seasonal allergy 13.25 10.42 70 106850 20880 63361222
Device use issue 13.10 10.42 19 106901 2611 63379491
Pulmonary artery stenosis congenital 13.02 10.42 7 106913 246 63381856
Device ineffective 12.99 10.42 7 106913 247 63381855
Generalised tonic-clonic seizure 12.89 10.42 18 106902 28998 63353104
Sepsis 12.83 10.42 181 106739 152942 63229160
Stridor 12.83 10.42 22 106898 3488 63378614
Nail dystrophy 12.82 10.42 12 106908 1031 63381071
Hyperplastic cholecystopathy 12.78 10.42 6 106914 157 63381945
Orthostatic hypotension 12.77 10.42 26 106894 36134 63345968
Cushing's syndrome 12.73 10.42 10 106910 677 63381425
Night sweats 12.69 10.42 41 106879 48773 63333329
Granuloma skin 12.62 10.42 37 106883 8400 63373702
Hypersensitivity 12.59 10.42 386 106534 292299 63089803
Haematemesis 12.53 10.42 91 106829 30321 63351781
Atopy 12.52 10.42 7 106913 266 63381836
Forced vital capacity decreased 12.47 10.42 12 106908 1067 63381035
Infrapatellar fat pad inflammation 12.44 10.42 6 106914 167 63381935
Pain in extremity 12.41 10.42 445 106475 331041 63051061
Cardiac murmur 12.39 10.42 53 106867 14499 63367603
Product quality issue 12.38 10.42 103 106817 35762 63346340
Tendon pain 12.36 10.42 21 106899 3305 63378797
Neuropathy peripheral 12.34 10.42 127 106793 113540 63268562
Vasculitis 12.32 10.42 62 106858 18147 63363955
Tricuspid valve incompetence 12.26 10.42 53 106867 14568 63367534
Tracheal disorder 12.24 10.42 7 106913 278 63381824
Bronchospasm paradoxical 12.22 10.42 5 106915 93 63382009
Hypothalamic pituitary adrenal axis suppression 12.22 10.42 6 106914 174 63381928
Posterior reversible encephalopathy syndrome 12.21 10.42 7 106913 17338 63364764
Erythema nodosum 12.18 10.42 26 106894 4849 63377253
Blood calcium decreased 12.17 10.42 16 106904 26435 63355667
Product use in unapproved indication 12.15 10.42 391 106529 178689 63203413
Rash maculo-papular 12.08 10.42 22 106898 31874 63350228
Injection site reaction 12.08 10.42 54 106866 58470 63323632
Congenital tricuspid valve incompetence 12.03 10.42 5 106915 97 63382005
Pulmonary embolism 12.00 10.42 269 106651 116415 63265687
Infusion site swelling 11.99 10.42 40 106880 9730 63372372
Congenital naevus 11.97 10.42 6 106914 182 63381920
Multiple organ dysfunction syndrome 11.93 10.42 52 106868 56700 63325402
Aural polyp 11.89 10.42 5 106915 100 63382002
Peak expiratory flow rate abnormal 11.89 10.42 5 106915 100 63382002
Fungal disease carrier 11.85 10.42 4 106916 42 63382060
Dysarthria 11.72 10.42 35 106885 42676 63339426
Dermatitis contact 11.72 10.42 43 106877 10965 63371137
Full blood count decreased 11.71 10.42 16 106904 26008 63356094
Respiratory syncytial virus infection 11.69 10.42 32 106888 6986 63375116
Labelled drug-drug interaction medication error 11.65 10.42 4 106916 13395 63368707
Hypersensitivity pneumonitis 11.57 10.42 18 106902 2632 63379470
Foreign body in respiratory tract 11.53 10.42 7 106913 311 63381791
Laryngeal oedema 11.52 10.42 28 106892 5690 63376412
Perfume sensitivity 11.34 10.42 10 106910 795 63381307
Blood pressure systolic 11.30 10.42 4 106916 49 63382053
Gingival hypertrophy 11.28 10.42 14 106906 1657 63380445
Adenovirus infection 11.28 10.42 21 106899 3550 63378552
Peripheral venous disease 11.25 10.42 6 106914 15471 63366631
Cytomegalovirus infection 11.25 10.42 67 106853 20885 63361217
Hypoaesthesia eye 11.25 10.42 7 106913 325 63381777
Lip dry 11.24 10.42 6 106914 15464 63366638
Asthenia 11.17 10.42 530 106390 383074 62999028
Nail disorder 11.12 10.42 4 106916 13011 63369091
Respiratory rate increased 11.08 10.42 49 106871 13599 63368503
Platelet count increased 11.08 10.42 59 106861 17652 63364450
Parosmia 11.05 10.42 29 106891 6177 63375925
Ileal ulcer 11.03 10.42 8 106912 480 63381622
Large intestinal stenosis 10.99 10.42 15 106905 1948 63380154
Skin atrophy 10.94 10.42 25 106895 4881 63377221
Bone pain 10.93 10.42 51 106869 54590 63327512
Cytopenia 10.92 10.42 3 106917 11598 63370504
Ataxia 10.89 10.42 6 106914 15189 63366913
Axillary pain 10.87 10.42 15 106905 1968 63380134
Norovirus infection 10.82 10.42 9 106911 661 63381441
Anal abscess 10.77 10.42 24 106896 4608 63377494
Granulomatosis with polyangiitis 10.76 10.42 16 106904 2249 63379853
Bronchitis bacterial 10.73 10.42 10 106910 854 63381248
Nasal oedema 10.67 10.42 13 106907 1509 63380593
Septic shock 10.67 10.42 67 106853 66562 63315540
Device failure 10.61 10.42 28 106892 5983 63376119
Faeces soft 10.55 10.42 27 106893 5665 63376437
Collateral circulation 10.50 10.42 3 106917 17 63382085
Mental status changes 10.48 10.42 33 106887 39566 63342536
Blood creatinine increased 10.44 10.42 96 106824 87748 63294354
Mitochondrial cytopathy 10.43 10.42 6 106914 241 63381861
Poisoning 10.43 10.42 5 106915 13695 63368407

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 858.84 10.67 644 56643 42012 34857632
Wheezing 427.44 10.67 427 56860 40975 34858669
Dyspnoea 320.33 10.67 1340 55947 375442 34524202
Chronic obstructive pulmonary disease 199.47 10.67 317 56970 48601 34851043
Cough 198.42 10.67 618 56669 149522 34750122
Productive cough 182.41 10.67 265 57022 37548 34862096
Frequent bowel movements 182.31 10.67 158 57129 12629 34887015
Bronchiectasis 162.22 10.67 132 57155 9669 34889975
Colitis ulcerative 151.49 10.67 160 57127 16360 34883284
Chest discomfort 148.24 10.67 296 56991 54234 34845410
Toxicity to various agents 144.66 10.67 74 57213 200288 34699356
Loss of personal independence in daily activities 142.12 10.67 220 57067 32959 34866685
Drug abuse 130.52 10.67 8 57279 99088 34800556
Growth failure 124.13 10.67 28 57259 47 34899597
Condition aggravated 123.99 10.67 632 56655 191564 34708080
Completed suicide 120.56 10.67 11 57276 98157 34801487
Sleep disorder due to a general medical condition 118.77 10.67 85 57202 5136 34894508
Therapeutic product effect incomplete 117.10 10.67 257 57030 50284 34849360
Eosinophilic granulomatosis with polyangiitis 106.59 10.67 56 57231 1931 34897713
Mycotic allergy 105.03 10.67 39 57248 569 34899075
Dust allergy 103.24 10.67 43 57244 863 34898781
Spirometry abnormal 101.92 10.67 40 57247 684 34898960
Faecal calprotectin increased 101.54 10.67 59 57228 2485 34897159
Steroid dependence 99.58 10.67 49 57238 1468 34898176
Acute kidney injury 98.33 10.67 222 57065 304766 34594878
Night sweats 97.64 10.67 131 57156 17221 34882423
Impaired quality of life 93.42 10.67 77 57210 5741 34893903
Cushingoid 92.86 10.67 57 57230 2657 34896987
Full blood count abnormal 90.21 10.67 131 57156 18537 34881107
Mite allergy 85.69 10.67 35 57252 667 34898977
Obstructive airways disorder 85.69 10.67 116 57171 15378 34884266
Colitis 82.97 10.67 188 57099 37562 34862082
Blood immunoglobulin E increased 80.86 10.67 51 57236 2495 34897149
Weight decreased 80.39 10.67 529 56758 175772 34723872
Off label use 79.07 10.67 1040 56247 418484 34481160
Death 77.29 10.67 363 56924 397686 34501958
Nasal polyps 76.66 10.67 49 57238 2454 34897190
Inappropriate schedule of product administration 75.29 10.67 249 57038 62047 34837597
Conjunctivitis allergic 74.45 10.67 37 57250 1133 34898511
Adrenal suppression 71.35 10.67 30 57257 617 34899027
Bronchospasm 61.87 10.67 82 57205 10649 34888995
Sinusitis 60.67 10.67 177 57110 41225 34858419
Intentional product use issue 58.46 10.67 223 57064 59593 34840051
Breath sounds abnormal 58.42 10.67 64 57223 6817 34892827
Sputum discoloured 56.72 10.67 67 57220 7745 34891899
Nipple swelling 56.58 10.67 21 57266 306 34899338
Febrile neutropenia 56.00 10.67 86 57201 136763 34762881
Ileal stenosis 52.40 10.67 31 57256 1350 34898294
Bronchopulmonary aspergillosis allergic 52.17 10.67 27 57260 902 34898742
Neutropenia 52.12 10.67 112 57175 156666 34742978
Haematochezia 50.08 10.67 179 57108 46355 34853289
Rhinitis 47.08 10.67 55 57232 6283 34893361
Aphthous ulcer 46.88 10.67 49 57238 4946 34894698
Respiratory tract infection 46.48 10.67 101 57186 19611 34880033
Cushing's syndrome 45.04 10.67 19 57268 394 34899250
Disease progression 43.17 10.67 69 57218 108008 34791636
Mucous stools 42.87 10.67 30 57257 1748 34897896
Hypotension 41.76 10.67 204 57083 221445 34678199
Delayed puberty 40.83 10.67 15 57272 212 34899432
Bronchiolitis 40.78 10.67 37 57250 3139 34896505
Product use issue 40.67 10.67 208 57079 63008 34836636
Lung diffusion test decreased 40.59 10.67 20 57267 601 34899043
Proctitis 40.55 10.67 33 57254 2416 34897228
Circumstance or information capable of leading to medication error 40.54 10.67 29 57258 1750 34897894
Product use in unapproved indication 40.49 10.67 330 56957 117169 34782475
Dyspnoea exertional 40.35 10.67 159 57128 43120 34856524
Malignant neoplasm progression 38.28 10.67 53 57234 87993 34811651
Nipple pain 38.11 10.67 22 57265 915 34898729
Therapeutic product effect decreased 37.68 10.67 134 57153 34609 34865035
Neuropathy peripheral 37.33 10.67 49 57238 83214 34816430
Nasal congestion 37.11 10.67 102 57185 22955 34876689
Gastrooesophageal reflux disease 36.71 10.67 141 57146 37783 34861861
Forced expiratory volume decreased 36.66 10.67 35 57252 3168 34896476
Herpes zoster meningoencephalitis 35.69 10.67 15 57272 308 34899336
Factor V Leiden mutation 35.44 10.67 11 57276 89 34899555
Dyspnoea at rest 34.94 10.67 37 57250 3791 34895853
Anal fissure 34.86 10.67 39 57248 4251 34895393
Adenovirus infection 34.76 10.67 43 57244 5214 34894430
Coagulation factor deficiency 34.15 10.67 12 57275 148 34899496
Pneumonia adenoviral 33.46 10.67 15 57272 362 34899282
Nasal obstruction 33.19 10.67 18 57269 662 34898982
Fall 32.02 10.67 198 57089 202687 34696957
Blood immunoglobulin E decreased 31.75 10.67 9 57278 51 34899593
Intentional overdose 31.63 10.67 16 57271 43658 34855986
Respiratory tract infection bacterial 31.60 10.67 25 57262 1757 34897887
Intestinal fistula 31.59 10.67 20 57267 985 34898659
Throat clearing 31.38 10.67 14 57273 334 34899310
Blood iron decreased 31.24 10.67 41 57246 5272 34894372
Lower respiratory tract infection 30.93 10.67 118 57169 31519 34868125
Cyanosis 30.77 10.67 66 57221 12698 34886946
Graft versus host disease 30.65 10.67 59 57228 10510 34889134
Thrombocytopenia 30.45 10.67 142 57145 156105 34743539
Infective pulmonary exacerbation of cystic fibrosis 30.37 10.67 46 57241 6755 34892889
Aspergillus infection 30.28 10.67 64 57223 12190 34887454
White blood cell count decreased 30.20 10.67 70 57217 95375 34804269
Upper-airway cough syndrome 30.04 10.67 33 57254 3525 34896119
Respiratory tract infection viral 29.76 10.67 28 57259 2489 34897155
Colitis microscopic 29.57 10.67 27 57260 2310 34897334
Allergy to animal 29.22 10.67 14 57273 395 34899249
Multiple allergies 29.16 10.67 30 57257 2973 34896671
Intestinal stenosis 29.12 10.67 26 57261 2160 34897484
Graft versus host disease in gastrointestinal tract 29.10 10.67 33 57254 3650 34895994
Mycobacterium test positive 28.80 10.67 14 57273 408 34899236
Musculoskeletal stiffness 28.38 10.67 21 57266 46659 34852985
Respiratory disorder 27.86 10.67 82 57205 19182 34880462
Intentional device misuse 27.77 10.67 11 57276 193 34899451
Adrenal insufficiency 27.62 10.67 67 57220 13980 34885664
Blood pressure increased 27.45 10.67 242 57045 87860 34811784
Heart rate increased 27.41 10.67 149 57138 46194 34853450
Neutrophil count decreased 27.37 10.67 26 57261 51078 34848566
Cataract 26.70 10.67 99 57188 26087 34873557
Pneumonia 26.43 10.67 779 56508 361848 34537796
Respiratory distress 26.26 10.67 122 57165 35543 34864101
Skin striae 26.24 10.67 15 57272 612 34899032
Nausea 26.14 10.67 396 56891 339512 34560132
Ear infection 25.94 10.67 54 57233 10177 34889467
Eye swelling 25.63 10.67 53 57234 9942 34889702
Electrocardiogram QT prolonged 25.45 10.67 18 57269 40934 34858710
Nasopharyngitis 25.44 10.67 199 57088 69769 34829875
Mucosal inflammation 25.31 10.67 16 57271 38606 34861038
Drug level below therapeutic 25.10 10.67 38 57249 5577 34894067
Lung disorder 25.04 10.67 118 57169 34578 34865066
Drug ineffective 24.84 10.67 948 56339 455803 34443841
Therapeutic response shortened 24.82 10.67 44 57243 7360 34892284
Congenital hiatus hernia 24.56 10.67 16 57271 828 34898816
Platelet count decreased 24.39 10.67 107 57180 119610 34780034
Procedural pneumothorax 23.81 10.67 7 57280 46 34899598
Blood creatinine increased 23.81 10.67 78 57209 94898 34804746
Asphyxia 23.41 10.67 41 57246 6794 34892850
Overdose 23.37 10.67 74 57213 90985 34808659
Suicide attempt 23.26 10.67 18 57269 39098 34860546
Foetal distress syndrome 22.95 10.67 17 57270 1083 34898561
Pharyngitis streptococcal 22.84 10.67 25 57262 2659 34896985
Psychotic disorder 22.69 10.67 6 57281 24446 34875198
Emphysema 22.67 10.67 49 57238 9476 34890168
Eosinophil count increased 22.62 10.67 46 57241 8526 34891118
Botulism 22.51 10.67 9 57278 162 34899482
Cytokine release syndrome 22.43 10.67 5 57282 22872 34876772
Periumbilical abscess 22.40 10.67 7 57280 58 34899586
Nasal turbinate hypertrophy 22.38 10.67 8 57279 104 34899540
Stomatitis 22.33 10.67 22 57265 42492 34857152
Drug level above therapeutic 22.19 10.67 31 57256 4230 34895414
Nodule 22.19 10.67 40 57247 6779 34892865
Normochromic normocytic anaemia 22.05 10.67 31 57256 4256 34895388
Rhinovirus infection 21.98 10.67 31 57256 4268 34895376
Leukopenia 21.61 10.67 44 57243 62812 34836832
Bronchitis 21.58 10.67 130 57157 41833 34857811
Reversible airways obstruction 21.28 10.67 12 57275 477 34899167
Eye infection fungal 21.21 10.67 11 57276 369 34899275
Encephalitis cytomegalovirus 21.19 10.67 13 57274 605 34899039
Hypoventilation 21.10 10.67 27 57260 3387 34896257
Respiratory tract haemorrhage 20.79 10.67 17 57270 1253 34898391
Anaemia 20.70 10.67 264 57023 233071 34666573
Dysarthria 20.69 10.67 16 57271 34766 34864878
Delirium 20.64 10.67 25 57262 43966 34855678
Oxygen saturation decreased 20.63 10.67 155 57132 53663 34845981
Fungal oesophagitis 20.53 10.67 11 57276 395 34899249
Gastrointestinal inflammation 20.50 10.67 27 57260 3484 34896160
Hypothalamic pituitary adrenal axis suppression 20.26 10.67 8 57279 139 34899505
Psoriatic arthropathy 20.08 10.67 4 57283 19794 34879850
Rhabdomyolysis 19.98 10.67 52 57235 68111 34831533
Coagulation factor V level abnormal 19.96 10.67 6 57281 43 34899601
Rhonchi 19.96 10.67 20 57267 1920 34897724
Diarrhoea haemorrhagic 19.91 10.67 38 57249 6726 34892918
Drug reaction with eosinophilia and systemic symptoms 19.87 10.67 15 57272 32997 34866647
Rubber sensitivity 19.86 10.67 9 57278 223 34899421
Liver disorder 19.85 10.67 15 57272 32982 34866662
Blood pressure fluctuation 19.80 10.67 88 57199 25161 34874483
Full blood count decreased 19.78 10.67 3 57284 18085 34881559
Gastrointestinal anastomotic leak 19.60 10.67 11 57276 433 34899211
Cardio-respiratory arrest 19.60 10.67 38 57249 55235 34844409
Tracheitis 19.47 10.67 13 57274 701 34898943
Osteoporosis 19.36 10.67 55 57232 12613 34887031
Adrenocortical insufficiency acute 19.30 10.67 18 57269 1582 34898062
Impaired work ability 19.26 10.67 38 57249 6892 34892752
Increased upper airway secretion 19.25 10.67 19 57268 1791 34897853
Granuloma 18.98 10.67 25 57262 3226 34896418
Therapeutic reaction time decreased 18.79 10.67 16 57271 1247 34898397
Heart rate decreased 18.72 10.67 102 57185 31643 34868001
Relapsing fever 18.70 10.67 8 57279 172 34899472
Hypogammaglobulinaemia 18.63 10.67 40 57247 7700 34891944
Pulmonary function test decreased 18.56 10.67 31 57256 4944 34894700
Epstein-Barr virus infection reactivation 18.54 10.67 15 57272 1089 34898555
Activated partial thromboplastin time shortened 18.53 10.67 11 57276 482 34899162
Penile erythema 18.45 10.67 8 57279 178 34899466
Serotonin syndrome 18.29 10.67 5 57282 19928 34879716
Intestinal obstruction 18.24 10.67 80 57207 22742 34876902
Retinal ischaemia 18.22 10.67 10 57277 377 34899267
Graft versus host disease in skin 18.17 10.67 27 57260 3898 34895746
Nephrectomy 18.17 10.67 13 57274 785 34898859
Weight increased 17.92 10.67 232 57055 92801 34806843
BK virus infection 17.84 10.67 33 57254 5705 34893939
Cerebral microangiopathy 17.81 10.67 8 57279 194 34899450
Gastrointestinal mucosa hyperaemia 17.80 10.67 9 57278 286 34899358
Rotavirus infection 17.79 10.67 10 57277 395 34899249
Renal impairment 17.75 10.67 87 57200 94426 34805218
Apoptosis 17.65 10.67 10 57277 401 34899243
Haemosiderosis 17.49 10.67 9 57278 297 34899347
Lactobacillus infection 17.49 10.67 9 57278 297 34899347
Cardiogenic shock 17.48 10.67 11 57276 26607 34873037
Confusional state 17.28 10.67 152 57135 144008 34755636
Small airways disease 17.26 10.67 5 57282 31 34899613
Bronchial obstruction 17.26 10.67 17 57270 1599 34898045
Anaphylactic reaction 17.21 10.67 101 57186 32200 34867444
Use of accessory respiratory muscles 17.19 10.67 10 57277 422 34899222
Visual evoked potentials abnormal 16.93 10.67 6 57281 76 34899568
Large intestine polyp 16.91 10.67 39 57248 7875 34891769
Rhinorrhoea 16.87 10.67 85 57202 25583 34874061
Tracheal haemorrhage 16.77 10.67 10 57277 442 34899202
Upper respiratory tract infection 16.73 10.67 102 57185 32957 34866687
Status asthmaticus 16.72 10.67 9 57278 326 34899318
Crohn's disease 16.72 10.67 23 57264 3094 34896550
Sputum increased 16.66 10.67 20 57267 2350 34897294
Prolonged expiration 16.62 10.67 8 57279 228 34899416
Urinary tract infection 16.60 10.67 76 57211 84005 34815639
Coma 16.54 10.67 31 57256 45647 34853997
Oedema mouth 16.50 10.67 15 57272 1276 34898368
Nasal disorder 16.48 10.67 18 57269 1910 34897734
Respiration abnormal 16.38 10.67 23 57264 3153 34896491
Malignant melanoma in situ 16.30 10.67 17 57270 1711 34897933
Parosmia 16.30 10.67 20 57267 2405 34897239
Adrenal cortex necrosis 16.14 10.67 4 57283 12 34899632
Sepsis 16.07 10.67 185 57102 166376 34733268
Memory impairment 16.04 10.67 29 57258 43289 34856355
Micturition urgency 16.03 10.67 34 57253 6491 34893153
Rash erythematous 15.92 10.67 82 57205 24895 34874749
Respiratory syncytial virus infection 15.81 10.67 28 57259 4681 34894963
Chronic kidney disease 15.80 10.67 27 57260 41183 34858461
Influenza 15.76 10.67 137 57150 49529 34850115
Constipation 15.73 10.67 146 57141 136836 34762808
Neurotoxicity 15.64 10.67 5 57282 18005 34881639
Hypercapnic coma 15.58 10.67 7 57280 170 34899474
Catarrh 15.54 10.67 13 57274 989 34898655
Metabolic acidosis 15.51 10.67 30 57257 43650 34855994
Growth retardation 15.36 10.67 17 57270 1831 34897813
White coat hypertension 15.32 10.67 7 57280 177 34899467
Hepatic function abnormal 15.29 10.67 31 57256 44332 34855312
Carotid arteriosclerosis 15.28 10.67 17 57270 1841 34897803
Emphysematous cholecystitis 15.26 10.67 5 57282 49 34899595
Defaecation urgency 15.26 10.67 20 57267 2569 34897075
Tachypnoea 15.18 10.67 65 57222 18287 34881357
Pouchitis 15.14 10.67 11 57276 680 34898964
Joint swelling 15.13 10.67 49 57238 59841 34839803
Blood pressure systolic increased 15.08 10.67 76 57211 22876 34876768
Adenoviral hepatitis 15.07 10.67 10 57277 534 34899110
Sinus operation 15.06 10.67 11 57276 686 34898958
Cardiac arrest 15.05 10.67 94 57193 96065 34803579
Fistula 14.94 10.67 34 57253 6806 34892838
Pulmonary oedema 14.91 10.67 35 57252 47494 34852150
Rectal haemorrhage 14.91 10.67 115 57172 40134 34859510
CADASIL 14.80 10.67 6 57281 112 34899532
Renal disorder 14.80 10.67 12 57275 25468 34874176
Cerebral artery embolism 14.77 10.67 12 57275 876 34898768
Body temperature decreased 14.75 10.67 51 57236 12983 34886661
Somnolence 14.75 10.67 114 57173 111002 34788642
Gastrointestinal wall thickening 14.61 10.67 15 57272 1483 34898161
Acute graft versus host disease in intestine 14.55 10.67 20 57267 2688 34896956
Precancerous condition 14.50 10.67 5 57282 58 34899586
Obstruction 14.49 10.67 20 57267 2699 34896945
Hyponatraemia 14.46 10.67 78 57209 82613 34817031
Respiratory syncytial virus bronchiolitis 14.40 10.67 9 57278 433 34899211
Gastrointestinal stenosis 14.38 10.67 6 57281 121 34899523
Acute myocardial infarction 14.24 10.67 43 57244 53676 34845968
Burns second degree 14.20 10.67 13 57274 1116 34898528
Polyp 14.19 10.67 24 57263 3868 34895776
Laryngeal cryptococcosis 14.17 10.67 3 57284 3 34899641
Eosinophilic oesophagitis 14.12 10.67 8 57279 321 34899323
Product substitution error 14.06 10.67 4 57283 23 34899621
Acute graft versus host disease in liver 14.05 10.67 15 57272 1551 34898093
Chronic sinusitis 14.05 10.67 18 57269 2261 34897383
Total lung capacity decreased 14.03 10.67 12 57275 941 34898703
Palmar-plantar erythrodysaesthesia syndrome 14 10.67 5 57282 16790 34882854
Cor pulmonale chronic 13.99 10.67 5 57282 65 34899579
Diabetic ketoacidosis 13.99 10.67 6 57281 18026 34881618
Varicella zoster virus infection 13.96 10.67 16 57271 1790 34897854
Drug level decreased 13.93 10.67 36 57251 7810 34891834
Neuroleptic malignant syndrome 13.86 10.67 6 57281 17928 34881716
Peak expiratory flow rate decreased 13.86 10.67 6 57281 133 34899511
Product quality issue 13.83 10.67 60 57227 16975 34882669
Fluctuance 13.78 10.67 4 57283 25 34899619
Erythema nodosum 13.67 10.67 14 57273 1380 34898264
Encephalopathy 13.67 10.67 23 57264 35296 34864348
Necrotising ulcerative gingivostomatitis 13.65 10.67 5 57282 70 34899574
Bronchial disorder 13.59 10.67 14 57273 1389 34898255
Magnetic resonance imaging spinal abnormal 13.53 10.67 6 57281 141 34899503
Pulmonary mass 13.53 10.67 49 57238 12763 34886881
Intentional self-injury 13.52 10.67 3 57284 13768 34885876
Neoplasm progression 13.50 10.67 11 57276 23289 34876355
Bacterial toxaemia 13.30 10.67 6 57281 147 34899497
Leukoplakia oral 13.22 10.67 5 57282 77 34899567
Necrotising retinitis 13.22 10.67 11 57276 831 34898813
Blood lactate dehydrogenase increased 13.14 10.67 11 57276 22979 34876665
Cardiopulmonary failure 13.09 10.67 24 57263 4121 34895523
Dehydration 13.06 10.67 143 57144 129826 34769818
Altered state of consciousness 13.03 10.67 11 57276 22882 34876762
Dysbiosis 13.01 10.67 9 57278 515 34899129
Renal failure 12.98 10.67 144 57143 130413 34769231
Injury 12.97 10.67 9 57278 20678 34878966
Astrovirus test positive 12.96 10.67 3 57284 6 34899638
Hypoglycaemia 12.92 10.67 46 57241 54594 34845050
Middle insomnia 12.90 10.67 32 57255 6770 34892874
Paranasal sinus mucosal hypertrophy 12.87 10.67 5 57282 83 34899561
Tuberculosis 12.87 10.67 37 57250 8540 34891104
Anal abscess 12.86 10.67 31 57256 6442 34893202
Respiratory tract congestion 12.84 10.67 30 57257 6109 34893535
Abdominal adhesions 12.72 10.67 14 57273 1499 34898145
Short-bowel syndrome 12.70 10.67 7 57280 266 34899378
Ascites 12.55 10.67 37 57250 46534 34853110
Sneezing 12.51 10.67 27 57260 5215 34894429
Disorientation 12.49 10.67 22 57265 33166 34866478
Pancytopenia 12.45 10.67 98 57189 95059 34804585
Foreign body aspiration 12.44 10.67 6 57281 172 34899472
Saccadic eye movement 12.40 10.67 6 57281 173 34899471
Congenital hydronephrosis 12.39 10.67 10 57277 723 34898921
Back pain 12.24 10.67 134 57153 121655 34777989
Seasonal allergy 12.23 10.67 31 57256 6644 34893000
Complicated appendicitis 12.14 10.67 4 57283 40 34899604
Sedation 12.07 10.67 10 57277 20996 34878648
Inflammatory bowel disease 11.99 10.67 19 57268 2901 34896743
Mental status changes 11.98 10.67 28 57259 38055 34861589
Stoma site abscess 11.88 10.67 4 57283 43 34899601
Orthopnoea 11.86 10.67 26 57261 5077 34894567
Increased bronchial secretion 11.82 10.67 15 57272 1866 34897778
Cardiac disorder 11.81 10.67 34 57253 43092 34856552
Allergic respiratory disease 11.79 10.67 4 57283 44 34899600
Uveitis 11.79 10.67 33 57254 7502 34892142
Pancreatic cyst 11.76 10.67 10 57277 778 34898866
Abdominal abscess 11.73 10.67 23 57264 4152 34895492
Loss of therapeutic response 11.73 10.67 9 57278 605 34899039
Skeletal injury 11.71 10.67 8 57279 448 34899196
Cystic fibrosis 11.67 10.67 14 57273 1644 34898000
Perfume sensitivity 11.62 10.67 5 57282 109 34899535
Plasma cell myeloma 11.61 10.67 33 57254 42004 34857640
Poor venous access 11.58 10.67 26 57261 5157 34894487
Hepatosplenic T-cell lymphoma 11.50 10.67 8 57279 462 34899182
Hypercapnia 11.42 10.67 23 57264 4232 34895412
Stress 11.40 10.67 87 57200 30260 34869384
Oropharyngeal pain 11.31 10.67 98 57189 35387 34864257
Haemoglobin decreased 11.31 10.67 135 57152 120637 34779007
Cytomegalovirus colitis 11.27 10.67 18 57269 2766 34896878
Tumour lysis syndrome 11.27 10.67 7 57280 17052 34882592
Double stranded DNA antibody positive 11.26 10.67 6 57281 213 34899431
Post procedural pneumonia 11.26 10.67 5 57282 118 34899526
Globulins decreased 11.23 10.67 6 57281 214 34899430
Device use issue 11.22 10.67 9 57278 645 34898999
Upper respiratory tract congestion 11.16 10.67 10 57277 835 34898809
Pseudomonas infection 11.14 10.67 45 57242 12337 34887307
Anosmia 11.10 10.67 22 57265 4002 34895642
Vomiting 11.09 10.67 315 56972 247306 34652338
Muscular weakness 11.03 10.67 72 57215 72825 34826819
Bone marrow oedema 11.01 10.67 9 57278 663 34898981
Asthmatic crisis 10.99 10.67 8 57279 496 34899148
Lipid metabolism disorder 10.98 10.67 7 57280 349 34899295
Asthma-chronic obstructive pulmonary disease overlap syndrome 10.97 10.67 12 57275 1275 34898369
Hepatitis toxic 10.97 10.67 16 57271 2271 34897373
Cytomegalovirus enteritis 10.95 10.67 8 57279 499 34899145
Central nervous system inflammation 10.89 10.67 6 57281 228 34899416
Gastroenteritis clostridial 10.87 10.67 7 57280 355 34899289
Lethargy 10.84 10.67 33 57254 41089 34858555
Seminoma 10.81 10.67 6 57281 231 34899413
Bacterial diarrhoea 10.73 10.67 4 57283 59 34899585
Gastrointestinal haemorrhage 10.72 10.67 93 57194 88384 34811260

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 2255.48 9.82 1864 135616 133231 79473677
Wheezing 1121.32 9.82 1185 136295 115479 79491429
Dyspnoea 724.06 9.82 3152 134328 853873 78753035
Obstructive airways disorder 678.98 9.82 506 136974 30953 79575955
Full blood count abnormal 594.95 9.82 520 136960 39954 79566954
Cough 540.87 9.82 1621 135859 365168 79241740
Sleep disorder due to a general medical condition 475.03 9.82 300 137180 13977 79592931
Chest discomfort 416.37 9.82 806 136674 137238 79469670
Colitis ulcerative 344.09 9.82 359 137121 34383 79572525
Toxicity to various agents 327.29 9.82 159 137321 421381 79185527
Completed suicide 320.20 9.82 28 137452 245739 79361169
Productive cough 302.74 9.82 545 136935 87786 79519122
Loss of personal independence in daily activities 301.95 9.82 593 136887 101987 79504921
Frequent bowel movements 276.10 9.82 296 137184 29243 79577665
Nasal polyps 264.04 9.82 162 137318 7165 79599743
Chronic sinusitis 262.11 9.82 201 137279 12825 79594083
Upper-airway cough syndrome 258.75 9.82 191 137289 11502 79595406
Chronic obstructive pulmonary disease 251.60 9.82 494 136986 84925 79521983
Bronchiectasis 228.26 9.82 235 137245 22151 79584757
Therapeutic product effect incomplete 212.77 9.82 631 136849 141014 79465894
Drug abuse 197.72 9.82 24 137456 162667 79444241
Sputum discoloured 196.39 9.82 214 137266 21529 79585379
Breath sounds abnormal 191.11 9.82 183 137297 15801 79591107
Bronchial secretion retention 188.03 9.82 106 137374 3998 79602910
Blood immunoglobulin E increased 186.70 9.82 120 137360 5762 79601146
Gastrooesophageal reflux disease 182.55 9.82 491 136989 103755 79503153
Eosinophil count increased 171.57 9.82 178 137302 16927 79589981
Acute kidney injury 167.61 9.82 408 137072 518996 79087912
Weight decreased 161.10 9.82 1106 136374 354092 79252816
Eosinophilic granulomatosis with polyangiitis 158.19 9.82 91 137389 3569 79603339
Blood test abnormal 157.68 9.82 173 137307 17537 79589371
Impaired quality of life 157.58 9.82 157 137323 14229 79592679
Reversible airways obstruction 156.42 9.82 76 137404 2100 79604808
Febrile neutropenia 154.92 9.82 104 137376 230895 79376013
Off label use 152.61 9.82 2299 135181 904916 78701992
Faecal calprotectin increased 151.51 9.82 103 137377 5438 79601470
Rhinitis allergic 149.59 9.82 142 137338 12127 79594781
Nasal congestion 146.72 9.82 373 137107 76179 79530729
Bronchospasm 144.91 9.82 196 137284 24663 79582245
Hand deformity 143.34 9.82 9 137471 103910 79502998
Contraindicated product administered 137.16 9.82 50 137430 157488 79449420
Polycystic ovaries 134.75 9.82 83 137397 3696 79603212
Dust allergy 133.02 9.82 61 137419 1475 79605433
Neutropenia 131.90 9.82 182 137298 287528 79319380
Vital capacity decreased 126.27 9.82 62 137418 1754 79605154
Respiratory symptom 126.13 9.82 87 137393 4704 79602204
Alopecia 124.51 9.82 129 137351 231226 79375682
Forced expiratory volume decreased 124.11 9.82 105 137375 7709 79599199
Condition aggravated 119.19 9.82 1354 136126 499770 79107138
Respiratory tract infection 118.00 9.82 260 137220 48429 79558479
Inappropriate schedule of product administration 115.00 9.82 496 136984 133132 79473776
Pneumonia 113.74 9.82 1681 135799 658565 78948343
Middle insomnia 112.95 9.82 139 137341 15930 79590978
Heart rate increased 110.01 9.82 456 137024 120268 79486640
Eosinophilia 109.73 9.82 242 137238 45103 79561805
Death 109.22 9.82 554 136926 565960 79040948
Dyspnoea exertional 108.70 9.82 364 137116 86709 79520199
Pericarditis 107.47 9.82 24 137456 104212 79502696
Asthmatic crisis 106.20 9.82 57 137423 1949 79604959
Therapeutic reaction time decreased 102.73 9.82 68 137412 3433 79603475
Intentional overdose 100.39 9.82 29 137451 105931 79500977
Glossodynia 100.29 9.82 27 137453 103310 79503598
Growth failure 97.02 9.82 30 137450 226 79606682
Steroid dependence 96.93 9.82 59 137421 2571 79604337
Duodenal ulcer perforation 96.79 9.82 4 137476 66207 79540701
Sleep apnoea syndrome 94.35 9.82 200 137280 36278 79570630
White blood cell count decreased 93.59 9.82 112 137368 188176 79418732
Haematochezia 93.56 9.82 348 137132 87297 79519611
Lung diffusion test abnormal 92.28 9.82 32 137448 358 79606550
Thrombocytopenia 92.14 9.82 200 137280 265059 79341849
Bronchopulmonary aspergillosis allergic 91.15 9.82 60 137420 3001 79603907
Multiple allergies 91.07 9.82 101 137379 10359 79596549
Bacterial disease carrier 90.55 9.82 47 137433 1499 79605409
Helicobacter infection 90.54 9.82 8 137472 69696 79537212
Rhinorrhoea 90.53 9.82 313 137167 75761 79531147
Female genital tract fistula 90.23 9.82 78 137402 5897 79601011
Sensitisation 89.23 9.82 61 137419 3250 79603658
Stomatitis 86.93 9.82 75 137405 146682 79460226
Spirometry abnormal 85.93 9.82 39 137441 920 79605988
Hypotension 85.11 9.82 430 137050 439887 79167021
Malignant neoplasm progression 84.89 9.82 66 137414 135924 79470984
Blood pressure increased 84.58 9.82 639 136841 210721 79396187
Synovitis 83.40 9.82 82 137398 150652 79456256
Mycotic allergy 82.77 9.82 44 137436 1475 79605433
Systemic lupus erythematosus 81.90 9.82 54 137426 121095 79485813
Ear pruritus 79.51 9.82 62 137418 4053 79602855
Eosinophilic bronchitis 77.83 9.82 30 137450 462 79606446
Sputum culture positive 77.50 9.82 59 137421 3722 79603186
Sinusitis fungal 76.75 9.82 49 137431 2325 79604583
Labile blood pressure 76.58 9.82 48 137432 2205 79604703
Platelet count decreased 76.00 9.82 137 137343 194527 79412381
Swelling 75.57 9.82 163 137317 216548 79390360
Joint swelling 75.07 9.82 251 137229 288395 79318513
Psoriatic arthropathy 74.52 9.82 21 137459 77978 79528930
Mite allergy 73.79 9.82 38 137442 1192 79605716
Ejection fraction 73.77 9.82 47 137433 2222 79604686
Fall 73.69 9.82 515 136965 487114 79119794
Arthropathy 73.39 9.82 120 137360 176991 79429917
Impaired healing 72.67 9.82 30 137450 87625 79519283
Pulmonary mass 72.57 9.82 157 137323 28877 79578031
Pulmonary function test abnormal 70.61 9.82 58 137422 4086 79602822
Rhinitis 70.46 9.82 106 137374 14701 79592207
Cushingoid 69.36 9.82 84 137396 9468 79597440
Blister 68.42 9.82 63 137417 119413 79487495
Confusional state 68.19 9.82 299 137181 317698 79289210
Total lung capacity decreased 67.77 9.82 49 137431 2856 79604052
Colitis 66.83 9.82 277 137203 73030 79533878
Sinus operation 66.82 9.82 46 137434 2479 79604429
Proctitis 66.42 9.82 68 137412 6364 79600544
Overdose 66.36 9.82 136 137344 184070 79422838
Sputum increased 65.20 9.82 58 137422 4555 79602353
Macular degeneration 64.22 9.82 88 137392 11208 79595700
Sinus disorder 63.78 9.82 128 137352 22336 79584572
Hyper IgE syndrome 63.40 9.82 27 137453 544 79606364
Intestinal stenosis 62.84 9.82 52 137428 3702 79603206
Salpingo-oophorectomy unilateral 62.58 9.82 30 137450 804 79606104
Wound 62.21 9.82 65 137415 116114 79490794
Conjunctivitis allergic 61.89 9.82 38 137442 1682 79605226
Pancytopenia 61.73 9.82 120 137360 165625 79441283
Disease progression 61.54 9.82 142 137338 184220 79422688
Drug level below therapeutic 61.50 9.82 80 137400 9690 79597218
Upper respiratory fungal infection 61.02 9.82 23 137457 332 79606576
Hepatic enzyme increased 60.67 9.82 141 137339 182469 79424439
Eczema 60.41 9.82 181 137299 40637 79566271
Polyp 60.02 9.82 72 137408 8035 79598873
Emphysema 58.91 9.82 103 137377 16197 79590711
Folliculitis 58.61 9.82 12 137468 55368 79551540
Adrenal suppression 58.38 9.82 34 137446 1365 79605543
Vocal cord dysfunction 58.25 9.82 26 137454 589 79606319
Neutrophil count decreased 56.88 9.82 47 137433 93912 79512996
Superinfection 56.48 9.82 55 137425 4847 79602061
Sinusitis 56.06 9.82 549 136931 194952 79411956
Nipple swelling 55.92 9.82 21 137459 300 79606608
Throat clearing 55.69 9.82 42 137438 2612 79604296
Mucosal inflammation 54.83 9.82 31 137449 75549 79531359
Graft versus host disease in gastrointestinal tract 54.69 9.82 61 137419 6295 79600613
Procedural pain 54.49 9.82 122 137358 22962 79583946
Paraesthesia oral 53.82 9.82 113 137367 20358 79586550
Gastrointestinal wall thickening 53.45 9.82 41 137439 2616 79604292
Aspergillus infection 52.99 9.82 108 137372 19053 79587855
Peak expiratory flow rate decreased 52.57 9.82 25 137455 658 79606250
Nephrectomy 52.39 9.82 37 137443 2078 79604830
Cardio-respiratory arrest 52.36 9.82 66 137414 108444 79498464
Defaecation urgency 52.02 9.82 57 137423 5767 79601141
Cushing's syndrome 51.91 9.82 28 137452 967 79605941
Graft versus host disease 51.79 9.82 93 137387 14933 79591975
Intentional product use issue 51.63 9.82 443 137037 151669 79455239
Anal fissure 51.52 9.82 65 137415 7638 79599270
Catarrh 51.41 9.82 37 137443 2141 79604767
Vomiting 50.78 9.82 825 136655 665003 78941905
Ileal stenosis 50.43 9.82 38 137442 2360 79604548
Abdominal pain 49.60 9.82 945 136535 388624 79218284
Laryngeal stenosis 49.57 9.82 28 137452 1060 79605848
Chest X-ray abnormal 48.77 9.82 64 137416 7819 79599089
Mucous stools 48.70 9.82 52 137428 5110 79601798
Therapeutic response shortened 48.19 9.82 93 137387 15770 79591138
Nausea 48.15 9.82 1270 136210 955926 78650982
Sneezing 47.56 9.82 105 137375 19578 79587330
Neoplasm progression 47.40 9.82 15 137465 51667 79555241
Intestinal obstruction 46.88 9.82 172 137308 42848 79564060
Suicide attempt 45.99 9.82 45 137435 82887 79524021
Rheumatoid arthritis 45.89 9.82 194 137286 208276 79398632
Coma 45.73 9.82 64 137416 100585 79506323
Decreased appetite 44.89 9.82 376 137104 342042 79264866
Infective pulmonary exacerbation of cystic fibrosis 44.88 9.82 80 137400 12771 79594137
Nasal obstruction 44.87 9.82 34 137446 2130 79604778
Upper respiratory tract infection 44.26 9.82 289 137191 90879 79516029
Embolism venous 44.11 9.82 45 137435 4194 79602714
Rales 43.12 9.82 102 137378 19899 79587009
Dysphonia 42.82 9.82 203 137277 56669 79550239
Sedation 42.62 9.82 18 137462 51877 79555031
Blood cholesterol increased 42.43 9.82 49 137431 83671 79523237
Drug intolerance 42.29 9.82 274 137206 263845 79343063
Ventricular failure 42.10 9.82 20 137460 525 79606383
Leukopenia 41.96 9.82 86 137394 116427 79490481
Ascites 41.90 9.82 41 137439 75521 79531387
Cystic fibrosis 41.86 9.82 42 137438 3838 79603070
Hypothyroidism 41.65 9.82 190 137290 52202 79554706
Mobility decreased 40.84 9.82 94 137386 122081 79484827
Hyponatraemia 40.70 9.82 163 137317 177685 79429223
Bronchitis 40.47 9.82 373 137107 130271 79476637
Butterfly rash 40.46 9.82 29 137451 1667 79605241
Renal impairment 40.44 9.82 138 137342 157645 79449263
Intestinal fistula 39.96 9.82 27 137453 1411 79605497
Liver injury 39.95 9.82 24 137456 56590 79550318
Treatment failure 39.81 9.82 155 137325 170331 79436577
Sopor 39.76 9.82 5 137475 33005 79573903
Pulmonary function test decreased 39.70 9.82 57 137423 7580 79599328
Vaginal flatulence 39.66 9.82 34 137446 2541 79604367
Somnolence 39.24 9.82 246 137234 238735 79368173
Anaphylactic reaction 39.16 9.82 263 137217 83480 79523428
Sepsis 38.95 9.82 288 137192 269140 79337768
Intentional self-injury 38.83 9.82 5 137475 32414 79574494
Dyspnoea at rest 38.70 9.82 55 137425 7247 79599661
Rhonchi 38.68 9.82 41 137439 3995 79602913
Hepatic ischaemia 38.51 9.82 24 137456 1091 79605817
Drug level decreased 38.44 9.82 80 137400 14322 79592586
Lung disorder 38.27 9.82 254 137226 80303 79526605
Drug specific antibody present 38.08 9.82 52 137428 6600 79600308
Electrocardiogram QT prolonged 37.65 9.82 61 137419 90325 79516583
Colitis microscopic 37.57 9.82 67 137413 10701 79596207
Restrictive pulmonary disease 37.42 9.82 33 137447 2562 79604346
Nipple pain 37.31 9.82 22 137458 904 79606004
Drug specific antibody 37.06 9.82 33 137447 2595 79604313
Anaemia 36.71 9.82 543 136937 444472 79162436
Drug level above therapeutic 36.69 9.82 59 137421 8664 79598244
Neurotoxicity 36.66 9.82 6 137474 32512 79574396
Systemic mycosis 36.65 9.82 33 137447 2633 79604275
Pulmonary fibrosis 36.58 9.82 162 137318 43950 79562958
Injury 36.49 9.82 48 137432 77448 79529460
Delirium 36.30 9.82 56 137424 84571 79522337
Product use in unapproved indication 36.30 9.82 620 136860 249739 79357169
Respiratory distress 36.05 9.82 197 137283 58142 79548766
Bronchial obstruction 35.59 9.82 33 137447 2735 79604173
Adenovirus infection 35.35 9.82 57 137423 8390 79598518
Hip arthroplasty 35.34 9.82 9 137471 35747 79571161
Allergy to animal 35.24 9.82 25 137455 1414 79605494
Discomfort 34.88 9.82 106 137374 125511 79481397
Abdominal discomfort 34.82 9.82 271 137209 250456 79356452
Encephalopathy 34.64 9.82 39 137441 67358 79539550
Eosinophilic oesophagitis 34.62 9.82 18 137462 576 79606332
Respiration abnormal 34.59 9.82 54 137426 7734 79599174
Irritable bowel syndrome 34.25 9.82 34 137446 62207 79544701
Metabolic acidosis 34.09 9.82 56 137424 82473 79524435
Cytokine release syndrome 33.82 9.82 10 137470 35988 79570920
Bronchomalacia 33.77 9.82 14 137466 263 79606645
Oropharyngeal pain 33.76 9.82 312 137168 109041 79497867
Palpitations 33.60 9.82 350 137130 126260 79480648
Scoliosis 33.49 9.82 52 137428 7412 79599496
Cyanosis 32.95 9.82 107 137373 25075 79581833
Endometriosis 32.94 9.82 36 137444 3632 79603276
Obstruction 32.59 9.82 40 137440 4570 79602338
Multiple sclerosis relapse 32.46 9.82 20 137460 46513 79560395
Asphyxia 32.34 9.82 66 137414 11654 79595254
Bronchiolitis 32.33 9.82 38 137442 4150 79602758
Muscle relaxant therapy 32.30 9.82 12 137468 166 79606742
Peripheral swelling 32.26 9.82 303 137177 269314 79337594
Illness 32.14 9.82 162 137318 46349 79560559
Lung opacity 32.00 9.82 42 137438 5132 79601776
Adrenal insufficiency 31.97 9.82 115 137365 28372 79578536
Haemoptysis 31.89 9.82 185 137295 55814 79551094
Rhabdomyolysis 31.60 9.82 83 137397 103048 79503860
Delayed puberty 31.42 9.82 12 137468 180 79606728
Hypothalamic pituitary adrenal axis suppression 31.21 9.82 14 137466 321 79606587
Liver disorder 30.99 9.82 48 137432 72369 79534539
Neuropathy peripheral 30.77 9.82 132 137348 141173 79465735
Bradycardia 30.53 9.82 125 137355 135432 79471476
Hiatus hernia 30.45 9.82 99 137381 23213 79583695
Drug interaction 30.40 9.82 518 136962 414665 79192243
Weight gain poor 30.26 9.82 20 137460 1007 79605901
Status asthmaticus 30.14 9.82 20 137460 1014 79605894
Rectal haemorrhage 30.09 9.82 230 137250 76070 79530838
Intentional device misuse 29.94 9.82 18 137462 767 79606141
Secretion discharge 29.60 9.82 74 137406 14948 79591960
Anosmia 29.54 9.82 54 137426 8790 79598118
Coagulation factor deficiency 29.43 9.82 11 137469 155 79606753
Plasma cell myeloma 29.41 9.82 29 137451 53230 79553678
Ejection fraction abnormal 29.28 9.82 28 137452 2412 79604496
Increased upper airway secretion 29.14 9.82 36 137444 4141 79602767
Haemoglobin decreased 29.04 9.82 244 137236 221875 79385033
Malignant mediastinal neoplasm 28.83 9.82 22 137458 1393 79605515
Depressed level of consciousness 28.70 9.82 79 137401 96573 79510335
Abscess 28.67 9.82 96 137384 22855 79584053
Hepatorenal syndrome 28.65 9.82 36 137444 4213 79602695
Throat irritation 28.56 9.82 143 137337 40803 79566105
Blood creatinine increased 27.89 9.82 155 137325 154902 79452006
Frustration tolerance decreased 27.88 9.82 48 137432 7454 79599454
Burns second degree 27.53 9.82 28 137452 2600 79604308
Cognitive disorder 27.46 9.82 49 137431 69877 79537031
Blood iron decreased 27.29 9.82 73 137407 15361 79591547
Hepatic function abnormal 27.14 9.82 53 137427 73054 79533854
C-reactive protein abnormal 27.10 9.82 26 137454 48341 79558567
Aphthous ulcer 27.01 9.82 77 137403 16812 79590096
Respiratory tract infection viral 27.00 9.82 35 137445 4224 79602684
Graft versus host disease in skin 26.82 9.82 42 137438 6031 79600877
Cardiac arrest 26.79 9.82 180 137300 171916 79434992
Pseudomonas infection 26.61 9.82 88 137392 20815 79586093
Herpes simplex oesophagitis 26.60 9.82 13 137467 364 79606544
Stress 26.54 9.82 231 137249 79381 79527527
Seasonal allergy 26.43 9.82 75 137405 16331 79590577
Pain 26.22 9.82 971 136509 702831 78904077
Pouchitis 26.13 9.82 18 137462 971 79605937
Device delivery system issue 25.92 9.82 16 137464 715 79606193
Cytomegalovirus colitis 25.88 9.82 36 137444 4649 79602259
Body temperature decreased 25.86 9.82 117 137363 32028 79574880
Respiratory tract inflammation 25.81 9.82 17 137463 851 79606057
Smoke sensitivity 25.78 9.82 15 137465 601 79606307
Viral infection 25.74 9.82 144 137336 42872 79564036
Tumour lysis syndrome 25.72 9.82 5 137475 23934 79582974
Poisoning 25.68 9.82 6 137474 25266 79581642
Rash 25.49 9.82 781 136699 577577 79029331
Respiratory disorder 25.42 9.82 148 137332 44708 79562200
Increased bronchial secretion 25.37 9.82 30 137450 3297 79603611
Sputum purulent 25.36 9.82 20 137460 1329 79605579
Respiratory tract infection bacterial 25.24 9.82 24 137456 2053 79604855
Use of accessory respiratory muscles 25.20 9.82 14 137466 513 79606395
Dysarthria 25.13 9.82 49 137431 67573 79539335
Hepatotoxicity 25.01 9.82 31 137449 51321 79555587
Growth retardation 24.66 9.82 23 137457 1920 79604988
Factor V Leiden mutation 24.57 9.82 10 137470 179 79606729
Tachypnoea 24.54 9.82 115 137365 31948 79574960
Mycobacterium test positive 24.45 9.82 13 137467 436 79606472
Congenital hiatus hernia 24.17 9.82 16 137464 808 79606100
Myelodysplastic syndrome 24.11 9.82 11 137469 30290 79576618
Eye pruritus 23.91 9.82 84 137396 20486 79586422
Sleep disorder due to general medical condition, insomnia type 23.73 9.82 24 137456 43532 79563376
Lung diffusion test decreased 23.73 9.82 19 137461 1291 79605617
Weight fluctuation 23.52 9.82 58 137422 11617 79595291
Musculoskeletal stiffness 23.43 9.82 191 137289 174817 79432091
Nonspecific reaction 23.00 9.82 25 137455 2507 79604401
Oropharyngeal discomfort 22.99 9.82 43 137437 7123 79599785
Lacrimation increased 22.94 9.82 88 137392 22389 79584519
Lower respiratory tract infection 22.88 9.82 331 137149 128889 79478019
Herpes zoster meningoencephalitis 22.86 9.82 15 137465 746 79606162
Prescribed overdose 22.86 9.82 19 137461 37864 79569044
Device expulsion 22.85 9.82 8 137472 25853 79581055
Circumstance or information capable of leading to medication error 22.81 9.82 31 137449 3917 79602991
Poor venous access 22.74 9.82 76 137404 18073 79588835
Atelectasis 22.74 9.82 113 137367 32144 79574764
Device use issue 22.73 9.82 26 137454 2758 79604150
Bone marrow failure 22.71 9.82 33 137447 51074 79555834
Apoptosis 22.66 9.82 13 137467 507 79606401
Sinus pain 22.56 9.82 30 137450 3712 79603196
Intestinal resection 22.47 9.82 30 137450 3727 79603181
Psychotic disorder 22.34 9.82 23 137457 41379 79565529
Knee arthroplasty 22.25 9.82 25 137455 43223 79563685
Mental status changes 21.98 9.82 52 137428 66907 79540001
Sensitivity to weather change 21.83 9.82 45 137435 8002 79598906
Osteomyelitis 21.73 9.82 15 137465 32850 79574058
Hyperkalaemia 21.31 9.82 113 137367 114285 79492623
Swollen tongue 21.30 9.82 136 137344 42434 79564474
Venous pressure jugular increased 21.27 9.82 18 137462 1322 79605586
Red blood cell sedimentation rate abnormal 21.25 9.82 5 137475 20958 79585950
White coat hypertension 21.20 9.82 15 137465 845 79606063
Parosmia 21.16 9.82 41 137439 6973 79599935
Respiratory arrest 21.12 9.82 42 137438 57508 79549400
Drug reaction with eosinophilia and systemic symptoms 21.01 9.82 50 137430 64194 79542714
Periumbilical abscess 20.98 9.82 7 137473 69 79606839
Blood pressure fluctuation 20.93 9.82 192 137288 66953 79539955
Adrenocortical insufficiency acute 20.86 9.82 26 137454 3017 79603891
Diarrhoea haemorrhagic 20.84 9.82 60 137420 13174 79593734
Inflammatory bowel disease 20.80 9.82 36 137444 5615 79601293
Cardiogenic shock 20.73 9.82 25 137455 41889 79565019
Hysterectomy 20.58 9.82 38 137442 6234 79600674
Bursitis 20.39 9.82 19 137461 35825 79571083
Botulism 20.39 9.82 11 137469 380 79606528
Bowel movement irregularity 20.31 9.82 38 137442 6296 79600612
Hypoventilation 20.31 9.82 41 137439 7183 79599725
Hypoglycaemia 20.27 9.82 98 137382 101496 79505412
Respiratory tract congestion 20.26 9.82 78 137402 19876 79587032
Pneumonia adenoviral 20.20 9.82 12 137468 500 79606408
Poisoning deliberate 20.09 9.82 4 137476 18824 79588084
Acute myocardial infarction 19.98 9.82 67 137413 76969 79529939
Pulmonary artery stenosis congenital 19.92 9.82 5 137475 15 79606893
Orthostatic hypotension 19.76 9.82 42 137438 56122 79550786
Fistula 19.73 9.82 58 137422 12882 79594026
Hypopnoea 19.68 9.82 34 137446 5295 79601613
Abscess intestinal 19.66 9.82 24 137456 2727 79604181
Sputum culture 19.65 9.82 9 137471 217 79606691
Myocardial infarction 19.49 9.82 213 137267 183916 79422992
Procedural pneumothorax 19.45 9.82 7 137473 88 79606820
Infective exacerbation of chronic obstructive airways disease 19.43 9.82 24 137456 2760 79604148
Blood calcium increased 19.21 9.82 50 137430 10350 79596558
Candida infection 19.07 9.82 122 137358 38092 79568816
Cortisol decreased 18.95 9.82 21 137459 2151 79604757
Oral candidiasis 18.95 9.82 101 137379 29527 79577381
Iron deficiency anaemia 18.86 9.82 91 137389 25581 79581327
Carpal tunnel syndrome 18.75 9.82 75 137405 19453 79587455
Posterior reversible encephalopathy syndrome 18.74 9.82 11 137469 26270 79580638
Aspirin-exacerbated respiratory disease 18.72 9.82 16 137464 1191 79605717
Oligoarthritis 18.71 9.82 13 137467 711 79606197
Dehydration 18.68 9.82 308 137172 247879 79359029
Perfume sensitivity 18.64 9.82 14 137466 865 79606043
Metastases to liver 18.62 9.82 13 137467 28301 79578607
Bone erosion 18.61 9.82 4 137476 17843 79589065
Loss of therapeutic response 18.57 9.82 14 137466 870 79606038
Osteoporosis 18.55 9.82 158 137322 53954 79552954
Vasculitis 18.46 9.82 89 137391 25013 79581895
Respiratory rate increased 18.42 9.82 80 137400 21520 79585388
Respiratory tract haemorrhage 18.33 9.82 19 137461 1804 79605104
Blood bilirubin increased 18.30 9.82 56 137424 66176 79540732
Infection 18.18 9.82 300 137180 241412 79365496
Incorrect dose administered 18.09 9.82 207 137273 76423 79530485
Nasal discharge discolouration 18.03 9.82 22 137458 2499 79604409
Coagulation factor V level abnormal 18.00 9.82 6 137474 59 79606849
Cardiac failure congestive 17.90 9.82 158 137322 142244 79464664
Gastroenteritis adenovirus 17.89 9.82 10 137470 371 79606537
Septic shock 17.85 9.82 131 137349 122670 79484238
Maternal exposure during pregnancy 17.83 9.82 150 137330 136388 79470520
Malaise 17.77 9.82 1023 136457 488846 79118062
Ventricular tachycardia 17.74 9.82 28 137452 41907 79565001
Lactic acidosis 17.70 9.82 62 137418 70297 79536611
Miosis 17.61 9.82 3 137477 15786 79591122
Migraine 17.47 9.82 229 137251 87264 79519644
Lip infection 17.46 9.82 8 137472 193 79606715
Aphonia 17.46 9.82 48 137432 10264 79596644
Sedation complication 17.42 9.82 3 137477 15666 79591242
Joint range of motion decreased 17.38 9.82 19 137461 33263 79573645
Aspartate aminotransferase increased 17.35 9.82 154 137326 138487 79468421
Normochromic normocytic anaemia 17.30 9.82 40 137440 7687 79599221
Eye infection fungal 17.30 9.82 11 137469 518 79606390
Underdose 17.23 9.82 19 137461 33132 79573776
Periorbital oedema 17.20 9.82 42 137438 8360 79598548
Hypertension 17.20 9.82 716 136764 330276 79276632
Erythema nodosum 17.17 9.82 32 137448 5285 79601623
Vaginal discharge 17.12 9.82 39 137441 7424 79599484
Heart rate decreased 17.08 9.82 191 137289 70125 79536783
Schizophrenia 17.07 9.82 3 137477 15437 79591471
Blood glucose increased 17.03 9.82 122 137358 114853 79492055
Altered state of consciousness 16.94 9.82 31 137449 43791 79563117
Extrapyramidal disorder 16.88 9.82 9 137471 22670 79584238
Acute myeloid leukaemia 16.84 9.82 17 137463 30868 79576040
Nasal disorder 16.55 9.82 26 137454 3743 79603165
Rhinovirus infection 16.54 9.82 40 137440 7913 79598995
Blood lactic acid increased 16.54 9.82 54 137426 12690 79594218
Sinus congestion 16.44 9.82 73 137407 19823 79587085
Dermatitis contact 16.39 9.82 49 137431 10984 79595924
Tracheostomy infection 16.35 9.82 6 137474 80 79606828
Osteonecrosis of jaw 16.34 9.82 31 137449 43195 79563713
Rheumatoid factor positive 16.24 9.82 51 137429 59788 79547120
Asthenia 16.21 9.82 719 136761 510970 79095938
Activated partial thromboplastin time shortened 16.20 9.82 13 137467 886 79606022
Oedema mouth 16.20 9.82 23 137457 3028 79603880
Exposure to allergen 16.14 9.82 9 137471 332 79606576
Cryptosporidiosis infection 16.13 9.82 12 137468 731 79606177
Product quality issue 16.11 9.82 107 137373 33833 79573075
Liver function test abnormal 16.10 9.82 57 137423 64418 79542490
Penile erythema 16.00 9.82 7 137473 151 79606757
Memory impairment 15.86 9.82 120 137360 111614 79495294
Drug withdrawal syndrome 15.84 9.82 22 137458 34696 79572212
Neutropenic sepsis 15.81 9.82 14 137466 27050 79579858
Bacterial toxaemia 15.79 9.82 7 137473 156 79606752
Bronchitis bacterial 15.73 9.82 16 137464 1486 79605422
Blood calcium decreased 15.72 9.82 19 137461 31800 79575108
Diarrhoea 15.71 9.82 1306 136174 879183 78727725
Mitochondrial neurogastrointestinal encephalopathy 15.69 9.82 4 137476 13 79606895
Uveitis 15.65 9.82 64 137416 16766 79590142
Ligament pain 15.56 9.82 8 137472 250 79606658
Tracheitis 15.49 9.82 15 137465 1313 79605595
Otorrhoea 15.45 9.82 17 137463 1728 79605180
Eye swelling 15.43 9.82 88 137392 26380 79580528
Lower respiratory tract congestion 15.42 9.82 26 137454 3971 79602937
Stridor 15.39 9.82 31 137449 5422 79601486
Kyphosis 15.35 9.82 21 137459 2670 79604238
Encephalitis cytomegalovirus 15.35 9.82 14 137466 1136 79605772
Cytopenia 15.30 9.82 8 137472 20375 79586533
Pharyngeal oedema 15.23 9.82 62 137418 16210 79590698
Acute graft versus host disease in intestine 15.21 9.82 26 137454 4015 79602893
Diabetic ketoacidosis 15.19 9.82 22 137458 34100 79572808
Hyperbilirubinaemia 15.16 9.82 12 137468 24506 79582402
Toxic epidermal necrolysis 15.13 9.82 34 137446 44547 79562361
Throat tightness 15.12 9.82 91 137389 27816 79579092
Palmar-plantar erythrodysaesthesia syndrome 15.11 9.82 21 137459 33113 79573795
Subarachnoid haemorrhage 15.10 9.82 12 137468 24453 79582455
Adrenal cortex necrosis 15.05 9.82 4 137476 16 79606892
Creatinine renal clearance decreased 14.96 9.82 7 137473 18995 79587913
Lactobacillus infection 14.94 9.82 9 137471 385 79606523
Laryngeal oedema 14.93 9.82 39 137441 8090 79598818
Red blood cell count decreased 14.93 9.82 50 137430 57463 79549445
BK virus infection 14.92 9.82 41 137439 8763 79598145
Small intestinal stenosis 14.89 9.82 12 137468 823 79606085
Infusion site swelling 14.84 9.82 38 137442 7788 79599120
Loss of consciousness 14.84 9.82 202 137278 167741 79439167
Night sweats 14.76 9.82 146 137334 51949 79554959
Terminal insomnia 14.67 9.82 14 137466 1203 79605705
Oropharyngitis fungal 14.61 9.82 6 137474 110 79606798
Human herpesvirus 6 infection 14.53 9.82 30 137450 5340 79601568
Right ventricular systolic pressure 14.50 9.82 4 137476 19 79606889
Pharyngitis streptococcal 14.45 9.82 46 137434 10668 79596240
Cholestasis 14.44 9.82 44 137436 52065 79554843
Large intestinal stenosis 14.38 9.82 21 137459 2835 79604073
Atypical mycobacterium test positive 14.33 9.82 4 137476 20 79606888
Respiratory syncytial virus infection 14.20 9.82 42 137438 9360 79597548
Rectal abscess 14.19 9.82 18 137462 2127 79604781
Weight increased 14.16 9.82 599 136881 276787 79330121
Blood alkaline phosphatase increased 14.14 9.82 59 137421 63605 79543303
Emphysematous cholecystitis 14.03 9.82 5 137475 61 79606847
Laryngeal cryptococcosis 14.02 9.82 3 137477 3 79606905
Rectal prolapse 13.97 9.82 18 137462 2160 79604748
Muscular weakness 13.96 9.82 194 137286 160535 79446373
Abdominal abscess 13.93 9.82 35 137445 7092 79599816
Tremor 13.92 9.82 388 137092 169695 79437213
Gastrointestinal disorder 13.89 9.82 139 137341 122066 79484842
Gamma-glutamyltransferase increased 13.88 9.82 48 137432 54632 79552276
Adenoviral hepatitis 13.79 9.82 12 137468 915 79605993
Akathisia 13.77 9.82 3 137477 13256 79593652
Urinary tract infection 13.76 9.82 364 137116 274148 79332760
Pain in extremity 13.73 9.82 502 136978 364036 79242872
Lethargy 13.68 9.82 83 137397 81209 79525699
Gastrointestinal inflammation 13.66 9.82 36 137444 7508 79599400
Polyneuropathy 13.51 9.82 13 137467 24138 79582770
Aplastic anaemia 13.48 9.82 7 137473 17898 79589010
Neutrophilia 13.45 9.82 37 137443 7914 79598994
Tenosynovitis 13.42 9.82 5 137475 15549 79591359
Ataxia 13.41 9.82 14 137466 25025 79581883
Renal tubular necrosis 13.41 9.82 14 137466 25025 79581883
Distal intestinal obstruction syndrome 13.38 9.82 11 137469 776 79606132
Retinal ischaemia 13.37 9.82 11 137469 777 79606131
Diastolic dysfunction 13.31 9.82 45 137435 10766 79596142
Cerebrovascular accident 13.29 9.82 188 137292 155104 79451804
Full blood count decreased 13.26 9.82 16 137464 26803 79580105
Gastrointestinal mucosa hyperaemia 13.22 9.82 9 137471 476 79606432
Serotonin syndrome 13.22 9.82 37 137443 44990 79561918
Small airways disease 13.19 9.82 4 137476 28 79606880
Respiratory syncytial virus bronchiolitis 13.14 9.82 9 137471 481 79606427
Hyperadrenocorticism 13.13 9.82 8 137472 349 79606559
Fungal oesophagitis 13.13 9.82 12 137468 976 79605932
Seizure 13.03 9.82 238 137242 188596 79418312
Haematocrit decreased 12.90 9.82 58 137422 61254 79545654
Nail dystrophy 12.88 9.82 12 137468 1001 79605907
Astrovirus test positive 12.81 9.82 3 137477 6 79606902
Influenza 12.75 9.82 303 137177 129303 79477605
Pharyngeal hypoaesthesia 12.73 9.82 8 137472 369 79606539
Metastases to bone 12.70 9.82 14 137466 24413 79582495
Nasopharyngitis 12.68 9.82 547 136933 253334 79353574
Bulimia nervosa 12.64 9.82 7 137473 255 79606653
Axillary pain 12.61 9.82 17 137463 2132 79604776
Ear infection 12.58 9.82 102 137378 34330 79572578
Diverticulum 12.57 9.82 55 137425 14841 79592067
International normalised ratio increased 12.49 9.82 90 137390 84631 79522277
Type IV hypersensitivity reaction 12.49 9.82 24 137456 4057 79602851
Anal fistula 12.43 9.82 33 137447 6911 79599997
Interstitial lung disease 12.42 9.82 129 137351 112471 79494437
Metastases to lung 12.40 9.82 8 137472 18155 79588753
Pleural effusion 12.38 9.82 176 137304 145086 79461822
Infusion site extravasation 12.38 9.82 42 137438 10066 79596842
Infrapatellar fat pad inflammation 12.31 9.82 6 137474 167 79606741
Malignant melanoma in situ 12.31 9.82 18 137462 2434 79604474
Foot deformity 12.29 9.82 14 137466 24060 79582848
Cardiac murmur 12.29 9.82 57 137423 15767 79591141
Hypoaesthesia eye 12.25 9.82 7 137473 271 79606637
Varicella zoster virus infection 12.24 9.82 25 137455 4416 79602492
Joint effusion 12.21 9.82 8 137472 18006 79588902
Obstructive pancreatitis 12.20 9.82 11 137469 879 79606029
Renal injury 12.19 9.82 7 137473 16920 79589988
Vocal cord disorder 12.19 9.82 14 137466 1492 79605416
Cataract 12.15 9.82 162 137318 61958 79544950
Alanine aminotransferase increased 12.14 9.82 202 137278 162368 79444540
Device ineffective 12.11 9.82 6 137474 173 79606735
Leukoplakia oral 12.09 9.82 7 137473 278 79606630
Paranasal sinus mucosal hypertrophy 12.06 9.82 5 137475 94 79606814
Blood pressure systolic increased 12.01 9.82 172 137308 66814 79540094
Congenital hydronephrosis 11.95 9.82 3 137477 9 79606899
Sprue-like enteropathy 11.95 9.82 13 137467 1305 79605603
Terminal ileitis 11.92 9.82 11 137469 906 79606002
Aural polyp 11.91 9.82 5 137475 97 79606811
Oesophageal candidiasis 11.91 9.82 39 137441 9179 79597729
Shock 11.90 9.82 37 137443 43511 79563397
Hypercapnic coma 11.87 9.82 8 137472 416 79606492
Rotavirus infection 11.84 9.82 10 137470 732 79606176
Sinusitis bacterial 11.82 9.82 15 137465 1772 79605136
Clostridium difficile infection 11.79 9.82 119 137361 42566 79564342
Proctalgia 11.76 9.82 41 137439 9960 79596948
Gastroenteritis norovirus 11.71 9.82 20 137460 3086 79603822
Lip dry 11.65 9.82 6 137474 15412 79591496
Ulcer 11.62 9.82 90 137390 29882 79577026
Bone pain 11.57 9.82 53 137427 55689 79551219
Sciatica 11.55 9.82 25 137455 33197 79573711
Haemorrhage intracranial 11.55 9.82 17 137463 26176 79580732
Febrile bone marrow aplasia 11.55 9.82 4 137476 13016 79593892
Tooth discolouration 11.53 9.82 12 137468 1145 79605763
Heart rate irregular 11.51 9.82 96 137384 32583 79574325
Hydronephrosis 11.49 9.82 8 137472 17446 79589462
Pulseless electrical activity 11.49 9.82 5 137475 14155 79592753
Hypersensitivity pneumonitis 11.45 9.82 22 137458 3717 79603191
Sacroiliitis 11.39 9.82 22 137458 3732 79603176
Blood immunoglobulin E decreased 11.38 9.82 5 137475 109 79606799
Human metapneumovirus test positive 11.35 9.82 6 137474 199 79606709
Bronchitis viral 11.31 9.82 12 137468 1171 79605737
Oxygen saturation decreased 11.30 9.82 297 137183 128750 79478158
Rash maculo-papular 11.24 9.82 54 137426 56024 79550884
Troponin increased 11.20 9.82 10 137470 19245 79587663
Seminoma 11.18 9.82 6 137474 205 79606703
Skin striae 11.17 9.82 15 137465 1873 79605035
Hypertriglyceridaemia 11.15 9.82 4 137476 12736 79594172
Disorientation 11.15 9.82 63 137417 62713 79544195
Blood pressure diastolic abnormal 11.14 9.82 10 137470 19192 79587716
Skin necrosis 11.12 9.82 61 137419 18026 79588882
Radiculopathy 11.10 9.82 37 137443 8787 79598121
Pulmonary oedema 11.05 9.82 98 137382 88156 79518752
Product substitution error 10.99 9.82 4 137476 52 79606856
Cerebral infarction 10.99 9.82 41 137439 45635 79561273
Anuria 10.91 9.82 12 137468 20951 79585957
Jaundice 10.91 9.82 51 137429 53298 79553610
Swelling face 10.90 9.82 178 137302 71034 79535874
Hyperplastic cholecystopathy 10.87 9.82 6 137474 217 79606691
Unevaluable event 10.86 9.82 54 137426 55531 79551377
Allergic respiratory disease 10.86 9.82 5 137475 122 79606786
Aggression 10.86 9.82 135 137345 50823 79556085
Platelet count increased 10.85 9.82 71 137409 22335 79584573
Multiple organ dysfunction syndrome 10.85 9.82 144 137336 120102 79486806
Hyperglycaemia 10.84 9.82 176 137304 70159 79536749
Secondary adrenocortical insufficiency 10.83 9.82 19 137461 2995 79603913
Post viral fatigue syndrome 10.78 9.82 7 137473 342 79606566
Acquired diaphragmatic eventration 10.78 9.82 9 137471 649 79606259
Hepatic cirrhosis 10.76 9.82 28 137452 34878 79572030
Exostosis 10.75 9.82 8 137472 16850 79590058
Tracheal haemorrhage 10.73 9.82 9 137471 653 79606255
Coprolalia 10.72 9.82 4 137476 56 79606852
Hypomagnesaemia 10.72 9.82 43 137437 46868 79560040
Suffocation feeling 10.70 9.82 14 137466 1706 79605202
Bronchial disorder 10.70 9.82 17 137463 2472 79604436
Hepatic cytolysis 10.68 9.82 19 137461 27132 79579776
Gingival pain 10.68 9.82 37 137443 8961 79597947
Nasal oedema 10.67 9.82 14 137466 1710 79605198
Fungal disease carrier 10.65 9.82 7 137473 349 79606559
Sputum abnormal 10.64 9.82 12 137468 1253 79605655
Rib deformity 10.60 9.82 6 137474 228 79606680
Balance disorder 10.60 9.82 114 137366 98743 79508165
Musculoskeletal pain 10.59 9.82 119 137361 102235 79504673
Oral hairy leukoplakia 10.59 9.82 3 137477 16 79606892
Gastrointestinal scarring 10.58 9.82 7 137473 353 79606555
COVID-19 10.57 9.82 351 137129 157323 79449585
Laryngeal obstruction 10.57 9.82 5 137475 130 79606778
Tracheal disorder 10.56 9.82 8 137472 501 79606407
Skin exfoliation 10.50 9.82 54 137426 55046 79551862
Alternaria infection 10.49 9.82 9 137471 673 79606235
Oropharyngeal candidiasis 10.46 9.82 14 137466 1743 79605165
Pneumonia aspiration 10.43 9.82 70 137410 66897 79540011
Device difficult to use 10.43 9.82 5 137475 13380 79593528
Metamorphopsia 10.43 9.82 12 137468 1281 79605627
Pertussis 10.42 9.82 10 137470 865 79606043
Type 2 diabetes mellitus 10.37 9.82 147 137333 56975 79549933
Device dislocation 10.37 9.82 18 137462 25952 79580956
Cross sensitivity reaction 10.36 9.82 21 137459 3691 79603217
Mitral valve incompetence 10.35 9.82 21 137459 28544 79578364
Dystonia 10.34 9.82 13 137467 21386 79585522
Arthropod sting 10.32 9.82 12 137468 1296 79605612
Haemosiderosis 10.31 9.82 8 137472 519 79606389
Injection site reaction 10.27 9.82 54 137426 54731 79552177
Paranoia 10.25 9.82 11 137469 19421 79587487
Norovirus infection 10.25 9.82 9 137471 695 79606213
Therapeutic product effect decreased 10.24 9.82 210 137270 163653 79443255
Arteriosclerosis coronary artery 10.23 9.82 59 137421 17757 79589151
Complex regional pain syndrome 10.23 9.82 15 137465 2033 79604875
Bronchopulmonary dysplasia 10.21 9.82 6 137474 245 79606663
Laryngitis fungal 10.20 9.82 5 137475 141 79606767
Granulomatosis with polyangiitis 10.19 9.82 18 137462 2852 79604056
Renal failure 10.19 9.82 266 137214 200702 79406206
Tongue blistering 10.18 9.82 13 137467 1546 79605362
Stoma site abscess 10.14 9.82 6 137474 248 79606660
Faecal calprotectin decreased 10.13 9.82 5 137475 143 79606765
Oropharyngeal swelling 10.08 9.82 12 137468 1328 79605580
Skin atrophy 10.06 9.82 27 137453 5691 79601217
Fatigue 10.02 9.82 1428 136052 928299 78678609
Gastrointestinal anastomotic leak 10.01 9.82 8 137472 542 79606366
Drug level increased 9.93 9.82 35 137445 39616 79567292
Orthopnoea 9.92 9.82 39 137441 10034 79596874
Nail disorder 9.91 9.82 4 137476 11848 79595060
Serum ferritin decreased 9.88 9.82 16 137464 2364 79604544
Anal abscess 9.85 9.82 37 137443 9318 79597590
Paranasal sinus hypersecretion 9.84 9.82 21 137459 3825 79603083
Agranulocytosis 9.84 9.82 42 137438 44988 79561920

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 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:35472 anti-inflammatory drugs
CHEBI has role CHEBI:35523 bronchodilator
CHEBI has role CHEBI:88188 allergenic drug
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D001993 Bronchodilator Agents
MeSH PA D005938 Glucocorticoids
MeSH PA D006728 Hormones
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D019141 Respiratory System Agents

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

DiseaseRelationSNOMED_IDDOID
Crohn's disease indication 34000006
Allergic rhinitis indication 61582004
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
Arginosuccinate Lyase Deficiency contraindication
Oropharyngeal Candidiasis contraindication
Nasal Septal Ulcers contraindication
Untreated Fungal Infection contraindication
Nasal Trauma contraindication
Uncontrolled Bacterial Infections 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
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 10166247 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 7759328 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8143239 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH SYMBICORT ASTRAZENECA N021929 July 21, 2006 RX AEROSOL, METERED INHALATION 8575137 Jan. 29, 2023 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
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
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)
EQ 90MCG BASE/INH;80MCG/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
0.16MG/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 9415009 May 28, 2030 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 8815258 March 17, 2031 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
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 RX 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 RX 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 RX 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 RX CAPSULE, DELAYED RELEASE ORAL 9707182 Sept. 9, 2036 TREATMENT OF MILD TO MODERATE ACTIVE CROHNS DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION July 23, 2023 NEW COMBINATION
2MG/ACTUATION BUDESONIDE PADAGIS ISRAEL A215328 April 12, 2023 RX AEROSOL, FOAM RECTAL Oct. 24, 2023 COMPETITIVE GENERIC THERAPY
4MG TARPEYO CALLIDITAS N215935 Dec. 15, 2021 RX CAPSULE, DELAYED RELEASE ORAL Dec. 15, 2024 NEW PRODUCT
EQ 90MCG BASE/INH;80MCG/INH AIRSUPRA ASTRAZENECA N214070 Jan. 10, 2023 RX AEROSOL, METERED INHALATION Jan. 10, 2026 NEW PRODUCT
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

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 Unclassified IC50 4.58 CHEMBL
Interleukin-5 receptor subunit alpha Unclassified 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

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 0115-1687 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
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 0186-0370 AEROSOL 160 ug RESPIRATORY (INHALATION) NDA 28 sections
SYMBICORT HUMAN PRESCRIPTION DRUG LABEL 2 0186-0372 AEROSOL 80 ug RESPIRATORY (INHALATION) NDA 28 sections
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 0186-0916 AEROSOL, POWDER 180 ug RESPIRATORY (INHALATION) NDA 25 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
PULMICORTFLEXHALER HUMAN PRESCRIPTION DRUG LABEL 1 0186-0917 AEROSOL, POWDER 90 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 0186-1988 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 0186-1989 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
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 0310-4616 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
Budesonide HUMAN OTC DRUG LABEL 1 0363-0048 SPRAY, METERED 32 ug NASAL ANDA 15 sections