budesonide ๐Ÿถ 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) 0.02 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.04 ยตM/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 1811.75 9.92 1345 80314 87992 50435473
Wheezing 692.39 9.92 663 80996 61384 50462081
Dyspnoea 557.87 9.92 2039 79620 545569 49977896
Obstructive airways disorder 533.65 9.92 326 81333 15326 50508139
Cough 315.24 9.92 979 80680 240285 50283180
Chest discomfort 269.54 9.92 513 81146 92209 50431256
Sleep disorder due to a general medical condition 227.10 9.92 144 81515 7227 50516238
Full blood count abnormal 202.26 9.92 218 81441 23170 50500295
Macular degeneration 195.80 9.92 172 81487 14216 50509249
Eosinophil count increased 189.69 9.92 138 81521 8692 50514773
Eosinophilic bronchitis 184.18 9.92 56 81603 427 50523038
Contraindicated product administered 173.45 9.92 19 81640 148939 50374526
Systemic lupus erythematosus 171.44 9.92 15 81644 140607 50382858
Chronic obstructive pulmonary disease 154.35 9.92 295 81364 53140 50470325
Completed suicide 143.41 9.92 21 81638 131868 50391597
Hand deformity 143.04 9.92 4 81655 100195 50423270
Chronic sinusitis 136.47 9.92 98 81561 6047 50517418
Toxicity to various agents 134.25 9.92 89 81570 212410 50311055
Colitis ulcerative 133.42 9.92 150 81509 16704 50506761
Pneumonia 133.19 9.92 1054 80605 377347 50146118
Nasal polyps 132.41 9.92 70 81589 2484 50520981
Respiratory symptom 130.38 9.92 68 81591 2346 50521119
Alopecia 123.49 9.92 128 81531 244919 50278546
Arthropathy 120.42 9.92 52 81607 157854 50365611
Productive cough 120.33 9.92 264 81395 52430 50471035
Synovitis 115.07 9.92 29 81630 123836 50399629
Gastrooesophageal reflux disease 112.53 9.92 324 81335 76104 50447361
Asthmatic crisis 111.89 9.92 54 81605 1574 50521891
Blood test abnormal 109.43 9.92 112 81547 11207 50512258
Glossodynia 109.42 9.92 26 81633 115543 50407922
Treatment failure 105.45 9.92 45 81614 137592 50385873
Sputum discoloured 103.95 9.92 118 81541 13277 50510188
Forced expiratory volume decreased 99.70 9.92 71 81588 4323 50519142
Upper-airway cough syndrome 98.30 9.92 93 81566 8457 50515008
Polyp 97.50 9.92 77 81582 5485 50517980
Pericarditis 96.95 9.92 8 81651 78681 50444784
Rheumatoid arthritis 92.00 9.92 115 81544 202435 50321030
Swelling 90.24 9.92 115 81544 200757 50322708
Labile blood pressure 87.48 9.92 46 81613 1614 50521851
Pain 86.92 9.92 563 81096 578340 49945125
Polycystic ovaries 85.29 9.92 52 81607 2432 50521033
Bronchospasm 84.69 9.92 112 81547 14742 50508723
Middle insomnia 83.18 9.92 91 81568 9830 50513635
Febrile neutropenia 83.07 9.92 27 81632 97640 50425825
Neutrophilia 79.35 9.92 57 81602 3518 50519947
Joint swelling 78.28 9.92 175 81484 245111 50278354
Blood immunoglobulin E increased 77.47 9.92 48 81611 2311 50521154
Bronchial secretion retention 77.11 9.92 41 81618 1472 50521993
Abdominal discomfort 76.62 9.92 162 81497 231479 50291986
Sleep apnoea syndrome 71.64 9.92 134 81525 23734 50499731
Heart rate increased 71.39 9.92 280 81379 76970 50446495
Rhinitis allergic 70.98 9.92 72 81587 7128 50516337
Eosinophilic granulomatosis with polyangiitis 69.89 9.92 42 81617 1913 50521552
Growth failure 67.93 9.92 24 81635 306 50523159
Reversible airways obstruction 67.59 9.92 33 81626 987 50522478
Anaphylactic reaction 66.29 9.92 215 81444 53840 50469625
Wound 65.81 9.92 45 81614 105749 50417716
Hepatic enzyme increased 65.53 9.92 75 81584 137305 50386160
Sinusitis fungal 65.46 9.92 35 81624 1271 50522194
Drug intolerance 63.03 9.92 165 81494 218939 50304526
White blood cell count decreased 62.14 9.92 58 81601 116664 50406801
Sensitisation 61.83 9.92 36 81623 1546 50521919
Vital capacity decreased 60.58 9.92 30 81629 926 50522539
Loss of personal independence in daily activities 60.01 9.92 248 81411 69802 50453663
Drug abuse 59.59 9.92 12 81647 59834 50463631
Dyspnoea exertional 59.44 9.92 200 81459 51033 50472432
Hyper IgE syndrome 58.01 9.92 23 81636 411 50523054
Upper respiratory fungal infection 57.59 9.92 18 81641 152 50523313
Dysphonia 57.32 9.92 165 81494 38727 50484738
Impaired healing 56.39 9.92 21 81638 69765 50453700
Sputum increased 56.32 9.92 36 81623 1831 50521634
Bronchiectasis 56.27 9.92 76 81583 10207 50513258
Respiratory tract infection 54.30 9.92 143 81516 31874 50491591
Intentional overdose 53.63 9.92 17 81642 62487 50460978
Frequent bowel movements 53.30 9.92 87 81572 13831 50509634
Embolism venous 53.18 9.92 39 81620 2486 50520979
Salpingo-oophorectomy unilateral 53.12 9.92 23 81636 518 50522947
Nasal congestion 52.77 9.92 192 81467 50928 50472537
Neutropenia 51.85 9.92 100 81559 147865 50375600
Rheumatoid factor positive 51.77 9.92 9 81650 49850 50473615
Thrombocytopenia 50.44 9.92 80 81579 127593 50395872
Lung diffusion test abnormal 49.43 9.92 16 81643 153 50523312
Circumstance or information capable of leading to medication error 49.26 9.92 41 81618 3147 50520318
Peak expiratory flow rate decreased 48.11 9.92 22 81637 566 50522899
Emphysema 47.93 9.92 66 81593 9027 50514438
Ventricular failure 47.44 9.92 19 81640 349 50523116
Sputum culture positive 47.02 9.92 29 81630 1385 50522080
Platelet count decreased 46.94 9.92 56 81603 100670 50422795
Hypothyroidism 46.68 9.92 141 81518 33984 50489481
Stomatitis 46.53 9.92 57 81602 101287 50422178
Eosinophilia 45.47 9.92 96 81563 18556 50504909
Butterfly rash 45.35 9.92 27 81632 1209 50522256
Death 44.89 9.92 324 81335 325055 50198410
Peripheral swelling 44.60 9.92 176 81483 205760 50317705
Hepatic ischaemia 44.42 9.92 21 81638 584 50522881
Therapeutic product effect decreased 44.22 9.92 96 81563 135954 50387511
Ejection fraction 43.47 9.92 26 81633 1174 50522291
Bronchitis 43.16 9.92 302 81357 103857 50419608
Therapeutic product effect incomplete 43.14 9.92 274 81385 91241 50432224
Malignant neoplasm progression 42.33 9.92 29 81630 68095 50455370
Intestinal stenosis 42.04 9.92 34 81625 2506 50520959
Aspergillus infection 41.32 9.92 53 81606 6768 50516697
Pancytopenia 41.01 9.92 45 81614 83985 50439480
Female genital tract fistula 40.48 9.92 39 81620 3627 50519838
Graft versus host disease in gastrointestinal tract 39.35 9.92 34 81625 2747 50520718
Infective pulmonary exacerbation of cystic fibrosis 38.12 9.92 55 81604 7854 50515611
Systemic mycosis 37.75 9.92 23 81636 1074 50522391
Throat irritation 37.71 9.92 121 81538 30118 50493347
Sinusitis 37.24 9.92 430 81229 170128 50353337
Sinus disorder 37.14 9.92 88 81571 18370 50505095
Restrictive pulmonary disease 36.97 9.92 25 81634 1399 50522066
Hepatorenal syndrome 36.88 9.92 27 81632 1716 50521749
Infusion related reaction 36.64 9.92 145 81514 169412 50354053
Bacterial infection 36.49 9.92 81 81578 16200 50507265
Breath sounds abnormal 35.83 9.92 53 81606 7739 50515726
Bulimia nervosa 35.75 9.92 16 81643 391 50523074
Intentional device misuse 35.66 9.92 19 81640 685 50522780
Discomfort 35.61 9.92 76 81583 108304 50415161
Acute kidney injury 35.48 9.92 219 81440 227839 50295626
Blister 35.19 9.92 52 81607 85366 50438099
Hip arthroplasty 35.08 9.92 4 81655 30425 50493040
Anosmia 34.60 9.92 37 81622 3894 50519571
Abdominal pain 34.50 9.92 554 81105 235674 50287791
Respiratory tract inflammation 34.38 9.92 17 81642 523 50522942
Vocal cord dysfunction 34.19 9.92 15 81644 349 50523116
Venous pressure jugular increased 34.11 9.92 17 81642 532 50522933
Ileal stenosis 33.89 9.92 24 81635 1448 50522017
Blood pressure increased 33.84 9.92 346 81313 132786 50390679
Pulmonary function test decreased 33.61 9.92 34 81625 3354 50520111
Therapeutic reaction time decreased 33.36 9.92 23 81636 1329 50522136
Muscle relaxant therapy 33.21 9.92 12 81647 164 50523301
Fall 32.78 9.92 364 81295 334568 50188897
Herpes simplex oesophagitis 32.77 9.92 11 81648 119 50523346
Oropharyngeal pain 32.47 9.92 226 81433 77575 50445890
Eczema 32.18 9.92 95 81564 22607 50500858
Adrenal suppression 31.86 9.92 19 81640 853 50522612
Oropharyngeal discomfort 31.67 9.92 35 81624 3823 50519642
Cystic fibrosis 30.74 9.92 30 81629 2834 50520631
Rash 30.36 9.92 510 81149 436961 50086504
Rhonchi 30.22 9.92 27 81632 2280 50521185
Upper respiratory tract infection 29.63 9.92 195 81464 65703 50457762
Frustration tolerance decreased 29.63 9.92 41 81618 5633 50517832
Total lung capacity decreased 29.61 9.92 21 81638 1270 50522195
Bronchopulmonary aspergillosis allergic 28.77 9.92 20 81639 1171 50522294
Gastrointestinal wall thickening 28.20 9.92 19 81640 1057 50522408
Hiatus hernia 28.17 9.92 79 81580 18265 50505200
Intestinal obstruction 27.99 9.92 100 81559 26283 50497182
Weight decreased 27.98 9.92 507 81152 220738 50302727
Blood cholesterol increased 27.57 9.92 29 81630 55186 50468279
Off label use 27.35 9.92 978 80681 473448 50050017
Drug specific antibody 27.22 9.92 23 81636 1802 50521663
Decreased appetite 27.21 9.92 201 81458 200722 50322743
Bronchomalacia 27.03 9.92 11 81648 211 50523254
Neutrophil count decreased 26.76 9.92 21 81638 46005 50477460
Hypotension 26.69 9.92 247 81412 235222 50288243
Rhinorrhoea 26.53 9.92 158 81501 51425 50472040
Respiratory distress 26.14 9.92 108 81551 30381 50493084
Cushingoid 26.07 9.92 42 81617 6603 50516862
Laryngeal stenosis 25.62 9.92 16 81643 781 50522684
Infective exacerbation of chronic obstructive airways disease 25.36 9.92 18 81641 1090 50522375
Dust allergy 25.22 9.92 14 81645 548 50522917
Eosinophilic oesophagitis 25.15 9.92 11 81648 254 50523211
Bronchial obstruction 25.10 9.92 19 81640 1271 50522194
Coma 25.05 9.92 33 81626 56846 50466619
Status asthmaticus 24.97 9.92 16 81643 817 50522648
Superinfection 24.85 9.92 23 81636 2033 50521432
Multiple allergies 24.75 9.92 47 81612 8416 50515049
Disease progression 24.72 9.92 76 81583 95790 50427675
Palpitations 24.66 9.92 247 81412 94259 50429206
Bone marrow failure 24.63 9.92 7 81652 27617 50495848
Sleep disorder due to general medical condition, insomnia type 24.51 9.92 10 81649 31437 50492028
Multiple sclerosis relapse 24.48 9.92 20 81639 42944 50480521
Device expulsion 24.44 9.92 8 81651 28814 50494651
Obstruction 24.34 9.92 23 81636 2088 50521377
Diastolic dysfunction 24.29 9.92 36 81623 5266 50518199
Psoriatic arthropathy 24.28 9.92 24 81635 47008 50476457
Graft versus host disease in skin 24.18 9.92 25 81634 2531 50520934
Ascites 24.01 9.92 14 81645 35847 50487618
Intestinal resection 23.93 9.92 24 81635 2343 50521122
Respiration abnormal 23.89 9.92 35 81624 5067 50518398
Mobility decreased 23.88 9.92 59 81600 79889 50443576
Pseudomonas infection 23.53 9.92 49 81610 9381 50514084
Aphonia 23.47 9.92 46 81613 8432 50515033
Respiratory disorder 23.31 9.92 106 81553 31081 50492384
Arthritis enteropathic 23.27 9.92 10 81649 221 50523244
Infusion site extravasation 23.26 9.92 41 81618 6935 50516530
Somnolence 22.97 9.92 151 81508 154834 50368631
Pouchitis 22.93 9.92 12 81647 417 50523048
Periorbital oedema 22.92 9.92 34 81625 4978 50518487
Lung disorder 22.90 9.92 137 81522 44662 50478803
Drug hypersensitivity 22.89 9.92 277 81382 250733 50272732
Sputum purulent 22.86 9.92 16 81643 947 50522518
Confusional state 22.84 9.92 191 81468 185737 50337728
Obstructive pancreatitis 22.82 9.92 10 81649 232 50523233
Irritable bowel syndrome 22.49 9.92 30 81629 51411 50472054
Pharyngeal hypoaesthesia 22.43 9.92 10 81649 242 50523223
Intentional self-injury 22.25 9.92 5 81654 23107 50500358
Haemoptysis 22.25 9.92 91 81568 25482 50497983
Nausea 21.85 9.92 924 80735 704474 49818991
Overdose 21.71 9.92 85 81574 99642 50423823
Increased upper airway secretion 21.56 9.92 26 81633 3118 50520347
Adrenal insufficiency 21.54 9.92 61 81598 14182 50509283
Candida infection 21.50 9.92 85 81574 23438 50500027
Crohn's disease 21.49 9.92 32 81627 4701 50518764
C-reactive protein abnormal 21.42 9.92 9 81650 27800 50495665
Swollen tongue 21.17 9.92 97 81562 28533 50494932
Sensitivity to weather change 20.96 9.92 36 81623 5965 50517500
Product quality issue 20.95 9.92 102 81557 30756 50492709
Asphyxia 20.88 9.92 34 81625 5393 50518072
Diverticulum 20.70 9.92 50 81609 10564 50512901
Bacterial disease carrier 20.49 9.92 14 81645 797 50522668
Throat tightness 20.42 9.92 77 81582 20770 50502695
Nasal discharge discolouration 20.39 9.92 18 81641 1496 50521969
Device malfunction 20.23 9.92 62 81597 15059 50508406
Maternal exposure during pregnancy 20.14 9.92 163 81496 159615 50363850
Neoplasm progression 20.07 9.92 11 81648 29146 50494319
Alternaria infection 19.96 9.92 9 81650 224 50523241
Haematochezia 19.77 9.92 121 81538 39761 50483704
Musculoskeletal stiffness 19.63 9.92 124 81535 128357 50395108
Drug level below therapeutic 19.49 9.92 27 81632 3713 50519752
Osteomyelitis 19.31 9.92 6 81653 22347 50501118
Kyphosis 19.15 9.92 21 81638 2274 50521191
Sedation 19.05 9.92 13 81646 30597 50492868
Diarrhoea 19.01 9.92 767 80892 587709 49935756
Mitochondrial neurogastrointestinal encephalopathy 18.96 9.92 4 81655 4 50523461
Oesophageal candidiasis 18.83 9.92 31 81628 4963 50518502
Catarrh 18.76 9.92 10 81649 361 50523104
Pharyngeal oedema 18.57 9.92 55 81604 13110 50510355
Ligament pain 18.40 9.92 8 81651 182 50523283
Vomiting 18.40 9.92 585 81074 460173 50063292
Rales 18.40 9.92 46 81613 9932 50513533
Malaise 18.39 9.92 688 80971 334844 50188621
Cardio-respiratory arrest 18.36 9.92 37 81622 53855 50469610
Rhinitis 18.27 9.92 41 81618 8260 50515205
Rectal prolapse 18.18 9.92 18 81641 1731 50521734
Sprue-like enteropathy 18.09 9.92 11 81648 512 50522953
Tracheostomy infection 18.07 9.92 5 81654 26 50523439
Suicide attempt 18.07 9.92 35 81624 51697 50471768
Cognitive disorder 18.03 9.92 27 81632 44096 50479369
Type IV hypersensitivity reaction 17.80 9.92 21 81638 2461 50521004
Acquired diaphragmatic eventration 17.80 9.92 10 81649 401 50523064
Tachycardia 17.67 9.92 242 81417 99521 50423944
Nocturnal dyspnoea 17.67 9.92 14 81645 1002 50522463
Colitis microscopic 17.59 9.92 35 81624 6485 50516980
Sinus congestion 17.50 9.92 56 81603 13915 50509550
Fatigue 17.14 9.92 951 80708 706650 49816815
Lip infection 17.09 9.92 6 81653 75 50523390
Otorrhoea 17.05 9.92 15 81644 1241 50522224
Impaired quality of life 16.94 9.92 33 81626 6023 50517442
Anaemia 16.92 9.92 296 81363 252160 50271305
Secretion discharge 16.87 9.92 44 81615 9747 50513718
Sinus operation 16.79 9.92 17 81642 1679 50521786
Faecal calprotectin increased 16.74 9.92 19 81640 2136 50521329
Gastrointestinal disorder 16.66 9.92 87 81572 94369 50429096
Smoke sensitivity 16.65 9.92 9 81650 334 50523131
Encephalopathy 16.50 9.92 18 81641 33693 50489772
Pulmonary function test abnormal 16.50 9.92 15 81644 1296 50522169
Hyperplastic cholecystopathy 16.47 9.92 6 81653 84 50523381
Female reproductive neoplasm 16.46 9.92 5 81654 38 50523427
Oligoarthritis 16.42 9.92 8 81651 238 50523227
Haemoglobin decreased 16.39 9.92 129 81530 127087 50396378
Metastases to liver 16.32 9.92 6 81653 20098 50503367
Blood immunoglobulin G decreased 16.28 9.92 18 81641 1967 50521498
Viral infection 16.16 9.92 93 81566 29893 50493572
Increased bronchial secretion 16.09 9.92 16 81643 1546 50521919
Small intestinal stenosis 16.05 9.92 10 81649 486 50522979
Dyslipidaemia 15.99 9.92 32 81627 5956 50517509
Mucosal inflammation 15.98 9.92 25 81634 40117 50483348
Incorrect dose administered 15.91 9.92 133 81526 48281 50475184
Pulmonary mass 15.83 9.92 66 81593 18639 50504826
Leukopenia 15.71 9.92 56 81603 67472 50455993
Throat clearing 15.65 9.92 14 81645 1184 50522281
Nasal oedema 15.65 9.92 12 81647 818 50522647
Dyspnoea at rest 15.62 9.92 24 81635 3623 50519842
Terminal insomnia 15.62 9.92 11 81648 658 50522807
Eczema impetiginous 15.52 9.92 4 81655 15 50523450
Tremor 15.46 9.92 266 81393 114637 50408828
Tachypnoea 15.25 9.92 55 81604 14522 50508943
Cryptosporidiosis infection 15.18 9.92 8 81651 282 50523183
Aspirin-exacerbated respiratory disease 15.10 9.92 12 81647 862 50522603
Endometriosis 14.97 9.92 25 81634 4050 50519415
Abdominal rigidity 14.93 9.92 16 81643 1688 50521777
Cytomegalovirus infection 14.90 9.92 63 81596 17899 50505566
Post viral fatigue syndrome 14.87 9.92 8 81651 294 50523171
Red blood cell sedimentation rate abnormal 14.83 9.92 4 81655 16339 50507126
Liver injury 14.83 9.92 11 81648 24795 50498670
Laryngeal oedema 14.70 9.92 28 81631 5025 50518440
Lung opacity 14.66 9.92 17 81642 1956 50521509
Hypocalcaemia 14.64 9.92 13 81646 26803 50496662
Anal fistula 14.60 9.92 20 81639 2722 50520743
Infection 14.58 9.92 194 81465 172760 50350705
Defaecation urgency 14.48 9.92 21 81638 3012 50520453
Aspiration 14.32 9.92 40 81619 9224 50514241
Rectal tenesmus 14.27 9.92 9 81650 447 50523018
Coprolalia 14.27 9.92 4 81655 22 50523443
Weight gain poor 14.27 9.92 11 81648 756 50522709
Graft versus host disease 14.18 9.92 31 81628 6135 50517330
Hysterectomy 14.15 9.92 36 81623 7854 50515611
Cardiac disorder 14.08 9.92 118 81541 42861 50480604
Atopy 13.93 9.92 7 81652 223 50523242
Abscess intestinal 13.86 9.92 14 81645 1379 50522086
Stridor 13.78 9.92 21 81638 3148 50520317
Mucous stools 13.72 9.92 20 81639 2882 50520583
Cushing's syndrome 13.63 9.92 10 81649 638 50522827
Metastases to bone 13.58 9.92 6 81653 17989 50505476
Pulmonary artery stenosis congenital 13.49 9.92 7 81652 239 50523226
Oedema peripheral 13.48 9.92 342 81317 157619 50365846
Distal intestinal obstruction syndrome 13.46 9.92 8 81651 357 50523108
Nephrectomy 13.45 9.92 11 81648 824 50522641
Norovirus infection 13.43 9.92 7 81652 241 50523224
Abscess 13.39 9.92 52 81607 14220 50509245
Bronchospasm paradoxical 13.35 9.92 5 81654 76 50523389
Device ineffective 13.24 9.92 6 81653 151 50523314
Weight fluctuation 13.23 9.92 33 81626 7115 50516350
Myelodysplastic syndrome 13.18 9.92 4 81655 15128 50508337
Large intestinal stenosis 13.07 9.92 15 81644 1707 50521758
Haematemesis 13.04 9.92 83 81576 27642 50495823
Plasma cell myeloma 12.96 9.92 19 81640 31303 50492162
Device failure 12.95 9.92 28 81631 5500 50517965
Generalised tonic-clonic seizure 12.93 9.92 14 81645 26296 50497169
Tooth disorder 12.93 9.92 12 81647 24216 50499249
Growth retardation 12.92 9.92 12 81647 1066 50522399
Infrapatellar fat pad inflammation 12.89 9.92 6 81653 161 50523304
Drug specific antibody present 12.82 9.92 21 81638 3347 50520118
Bowel movement irregularity 12.82 9.92 23 81636 3945 50519520
Respiratory rate increased 12.81 9.92 44 81615 11341 50512124
Knee arthroplasty 12.74 9.92 24 81635 35822 50487643
Respiratory tract congestion 12.73 9.92 51 81608 14148 50509317
Paraesthesia oral 12.69 9.92 46 81613 12175 50511290
Skin dystrophy 12.57 9.92 4 81655 36 50523429
Bronchitis bacterial 12.53 9.92 10 81649 723 50522742
Hypersensitivity pneumonitis 12.46 9.92 17 81642 2305 50521160
Ageusia 12.37 9.92 44 81615 11539 50511926
Faeces soft 12.34 9.92 23 81636 4061 50519404
Small intestinal obstruction 12.29 9.92 55 81604 16013 50507452
Congenital naevus 12.27 9.92 6 81653 180 50523285
Congenital tricuspid valve incompetence 12.23 9.92 5 81654 97 50523368
Delayed puberty 12.19 9.92 5 81654 98 50523367
Gingival hypertrophy 12.12 9.92 13 81646 1373 50522092
Infusion site swelling 12.11 9.92 32 81627 7144 50516321
Aural polyp 12.09 9.92 5 81654 100 50523365
Disease recurrence 11.97 9.92 64 81595 20017 50503448
Injection site reaction 11.96 9.92 41 81618 49991 50473474
Perfume sensitivity 11.93 9.92 9 81650 599 50522866
Intestinal fistula 11.91 9.92 10 81649 777 50522688
Pallor 11.89 9.92 71 81588 23128 50500337
Clostridium difficile infection 11.87 9.92 76 81583 25363 50498102
Bronchial hyperreactivity 11.84 9.92 13 81646 1409 50522056
Myalgia 11.76 9.92 273 81386 124046 50399419
Renal impairment 11.56 9.92 73 81586 75588 50447877
Sputum culture 11.53 9.92 5 81654 113 50523352
Blood pressure systolic 11.47 9.92 4 81655 49 50523416
Arrhythmia 11.41 9.92 92 81567 33040 50490425
Ear pruritus 11.35 9.92 17 81642 2509 50520956
Allergy to animal 11.34 9.92 10 81649 830 50522635
Sinus pain 11.30 9.92 16 81643 2245 50521220
Diabetes mellitus 11.30 9.92 125 81534 48908 50474557
Photosensitivity reaction 11.27 9.92 46 81613 12865 50510600
Product taste abnormal 11.27 9.92 14 81645 1731 50521734
Hyponatraemia 11.24 9.92 100 81559 96039 50427426
Product use in unapproved indication 11.16 9.92 255 81404 115564 50407901
Condition aggravated 11.14 9.92 586 81073 296472 50226993
Collateral circulation 11.11 9.92 3 81656 14 50523451
Steroid dependence 11.09 9.92 7 81652 348 50523117
Type 2 diabetes mellitus 11.06 9.92 94 81565 34281 50489184
Adenovirus infection 11.06 9.92 19 81640 3149 50520316
Anal abscess 11.02 9.92 21 81638 3770 50519695
Language disorder 11.00 9.92 14 81645 1774 50521691
Sacroiliitis 11.00 9.92 17 81642 2580 50520885
Kussmaul respiration 10.97 9.92 6 81653 228 50523237
Urinary tract discomfort 10.95 9.92 6 81653 229 50523236
Mitochondrial cytopathy 10.95 9.92 6 81653 229 50523236
Granulomatosis with polyangiitis 10.92 9.92 14 81645 1786 50521679
Gastrointestinal scarring 10.92 9.92 6 81653 230 50523235
Drug level decreased 10.89 9.92 29 81630 6504 50516961
Red blood cell count decreased 10.88 9.92 24 81635 33811 50489654
Hepatotoxicity 10.80 9.92 17 81642 27209 50496256
Incorrect route of product administration 10.79 9.92 59 81600 18607 50504858
Pulmonary contusion 10.78 9.92 3 81656 16 50523449
Left ventricular failure 10.75 9.92 24 81635 4817 50518648
Feeling jittery 10.74 9.92 41 81618 11119 50512346
Bronchial wall thickening 10.70 9.92 10 81649 895 50522570
Behaviour disorder 10.67 9.92 16 81643 2364 50521101
Symptom recurrence 10.65 9.92 9 81650 705 50522760
Type I hypersensitivity 10.65 9.92 16 81643 2369 50521096
Tongue blistering 10.60 9.92 12 81647 1346 50522119
Drug withdrawal syndrome 10.59 9.92 15 81644 25066 50498399
Nasal discomfort 10.59 9.92 21 81638 3883 50519582
Tendon pain 10.58 9.92 18 81641 2960 50520505
Skin atrophy 10.52 9.92 22 81637 4223 50519242
Stenotrophomonas test positive 10.48 9.92 3 81656 18 50523447
Laryngitis fungal 10.48 9.92 5 81654 142 50523323
Hyperglycaemia 10.40 9.92 97 81562 36308 50487157
Forced vital capacity decreased 10.37 9.92 10 81649 931 50522534
Bone erosion 10.35 9.92 3 81656 11684 50511781
Herpes zoster oticus 10.34 9.92 6 81653 256 50523209
Cryptococcal meningoencephalitis 10.33 9.92 4 81655 67 50523398
Blood glucose increased 10.30 9.92 70 81589 71254 50452211
Functional residual capacity decreased 10.27 9.92 4 81655 68 50523397
Dermatitis contact 10.24 9.92 34 81625 8612 50514853
Depressed level of consciousness 10.23 9.92 46 81613 51907 50471558
Rash maculo-papular 10.22 9.92 17 81642 26624 50496841
Cyanosis 10.17 9.92 50 81609 15134 50508331
Faeces discoloured 10.03 9.92 52 81607 16072 50507393
Tricuspid valve incompetence 9.99 9.92 44 81615 12726 50510739
Chest pain 9.98 9.92 364 81295 176518 50346947
Cross sensitivity reaction 9.94 9.92 14 81645 1955 50521510

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 694.56 10.24 506 45429 33343 29495249
Wheezing 316.18 10.24 320 45615 32920 29495672
Dyspnoea 279.86 10.24 1122 44813 325610 29202982
Cough 192.03 10.24 529 45406 126198 29402394
Productive cough 130.52 10.24 199 45736 31060 29497532
Colitis ulcerative 128.78 10.24 127 45808 12642 29515950
Chronic obstructive pulmonary disease 126.96 10.24 228 45707 40727 29487865
Toxicity to various agents 126.19 10.24 56 45879 173605 29354987
Chest discomfort 122.62 10.24 240 45695 45743 29482849
Frequent bowel movements 116.42 10.24 104 45831 9135 29519457
Growth failure 108.54 10.24 24 45911 38 29528554
Completed suicide 101.36 10.24 11 45924 90235 29438357
Drug abuse 94.29 10.24 8 45927 79875 29448717
Eosinophilic granulomatosis with polyangiitis 90.94 10.24 44 45891 1342 29527250
Acute kidney injury 89.52 10.24 173 45762 265094 29263498
Bronchiectasis 80.74 10.24 73 45862 6512 29522080
Condition aggravated 77.16 10.24 438 45497 145857 29382735
Night sweats 76.83 10.24 105 45830 14827 29513765
Cushingoid 75.18 10.24 47 45888 2391 29526201
Adrenal suppression 75.02 10.24 29 45906 503 29528089
Therapeutic product effect incomplete 72.61 10.24 177 45758 39128 29489464
Sleep disorder due to a general medical condition 71.19 10.24 50 45885 3096 29525496
Bronchospasm 69.29 10.24 80 45855 9529 29519063
Loss of personal independence in daily activities 66.82 10.24 132 45803 25308 29503284
Blood immunoglobulin E increased 66.33 10.24 40 45895 1907 29526685
Faecal calprotectin increased 63.56 10.24 36 45899 1525 29527067
Spirometry abnormal 62.02 10.24 23 45912 354 29528238
Nasal polyps 61.97 10.24 37 45898 1732 29526860
Colitis 59.08 10.24 142 45793 31106 29497486
Mycotic allergy 58.16 10.24 20 45915 244 29528348
Death 57.59 10.24 305 45630 341779 29186813
Weight decreased 55.12 10.24 412 45523 150493 29378099
Ileal stenosis 54.56 10.24 30 45905 1199 29527393
Dust allergy 52.82 10.24 22 45913 467 29528125
Mite allergy 47.28 10.24 18 45917 299 29528293
Cushing's syndrome 46.57 10.24 19 45916 382 29528210
Circumstance or information capable of leading to medication error 46.04 10.24 29 45906 1495 29527097
Full blood count abnormal 44.47 10.24 82 45853 14931 29513661
Impaired quality of life 44.41 10.24 35 45900 2584 29526008
Mucous stools 43.03 10.24 25 45910 1112 29527480
Off label use 42.93 10.24 680 45255 300120 29228472
Sinusitis 42.83 10.24 134 45801 34216 29494376
Neutropenia 42.49 10.24 88 45847 131623 29396969
Breath sounds abnormal 42 10.24 47 45888 5410 29523182
Bronchiolitis 40.76 10.24 34 45901 2721 29525871
Conjunctivitis allergic 40.74 10.24 20 45915 630 29527962
Product use issue 40.64 10.24 173 45762 51271 29477321
Obstructive airways disorder 40.24 10.24 66 45869 10950 29517642
Lung diffusion test decreased 39.62 10.24 19 45916 568 29528024
Proctitis 39.60 10.24 30 45905 2089 29526503
Herpes zoster meningoencephalitis 39.02 10.24 15 45920 256 29528336
Dyspnoea at rest 38.17 10.24 35 45900 3179 29525413
Steroid dependence 37.64 10.24 15 45920 283 29528309
Aphthous ulcer 36.51 10.24 38 45897 4030 29524562
Febrile neutropenia 34.51 10.24 77 45858 112163 29416429
Blood immunoglobulin E decreased 34.22 10.24 9 45926 39 29528553
Cyanosis 33.95 10.24 62 45873 11205 29517387
Adrenal insufficiency 32.03 10.24 60 45875 11054 29517538
Graft versus host disease 31.60 10.24 55 45880 9573 29519019
Asphyxia 31.39 10.24 40 45895 5275 29523317
Infective pulmonary exacerbation of cystic fibrosis 30.79 10.24 43 45892 6193 29522399
Pneumonia 30.76 10.24 681 45254 319491 29209101
Nasal congestion 30.66 10.24 81 45854 18798 29509794
Sputum discoloured 30.55 10.24 44 45891 6519 29522073
Eye swelling 30.45 10.24 51 45884 8606 29519986
Intentional device misuse 30.17 10.24 11 45924 161 29528431
Disease progression 29.67 10.24 51 45884 81865 29446727
Heart rate increased 28.50 10.24 128 45807 38810 29489782
Forced expiratory volume decreased 28.39 10.24 28 45907 2785 29525807
Mycobacterium test positive 27.50 10.24 13 45922 376 29528216
Intestinal fistula 27.33 10.24 17 45918 857 29527735
Respiratory tract infection 27.32 10.24 69 45866 15582 29513010
Upper-airway cough syndrome 26.85 10.24 28 45907 2975 29525617
Colitis microscopic 26.58 10.24 22 45913 1741 29526851
Therapeutic product effect decreased 26.38 10.24 103 45832 29348 29499244
Lung disorder 26.24 10.24 105 45830 30257 29498335
Nasal obstruction 25.94 10.24 14 45921 539 29528053
Neuropathy peripheral 25.92 10.24 44 45891 70983 29457609
Allergy to animal 25.76 10.24 11 45924 249 29528343
Foetal distress syndrome 25.25 10.24 17 45918 982 29527610
Delayed puberty 25.13 10.24 10 45925 188 29528404
Thrombocytopenia 24.39 10.24 117 45818 134706 29393886
Musculoskeletal stiffness 24.26 10.24 14 45921 37444 29491148
Procedural pneumothorax 24.18 10.24 7 45928 46 29528546
Intentional overdose 24.11 10.24 15 45920 38513 29490079
Lower respiratory tract infection 23.99 10.24 93 45842 26409 29502183
Throat clearing 23.98 10.24 10 45925 213 29528379
Bronchitis 23.90 10.24 117 45818 36751 29491841
Rhinitis 23.67 10.24 33 45902 4745 29523847
Eye infection fungal 23.40 10.24 11 45924 314 29528278
Apoptosis 23.35 10.24 10 45925 228 29528364
Fungal oesophagitis 23.31 10.24 11 45924 317 29528275
Botulism 23.03 10.24 9 45926 161 29528431
Fall 22.95 10.24 171 45764 177007 29351585
Nasopharyngitis 22.92 10.24 165 45770 59500 29469092
Periumbilical abscess 22.77 10.24 7 45928 58 29528534
Hypotension 22.67 10.24 193 45742 194161 29334431
Malignant neoplasm progression 22.42 10.24 51 45884 73808 29454784
Gastrointestinal anastomotic leak 22.30 10.24 11 45924 350 29528242
Granuloma 22.08 10.24 23 45912 2441 29526151
Platelet count decreased 21.88 10.24 86 45849 104586 29424006
Lactic acidosis 21.52 10.24 10 45925 30237 29498355
Eosinophil count increased 21.51 10.24 40 45895 7329 29521263
Intestinal stenosis 21.33 10.24 20 45915 1868 29526724
Gastrooesophageal reflux disease 21.17 10.24 101 45834 31395 29497197
Dyspnoea exertional 21.00 10.24 112 45823 36378 29492214
Tracheitis 20.99 10.24 13 45922 650 29527942
Respiratory distress 20.89 10.24 102 45833 32004 29496588
Hypothalamic pituitary adrenal axis suppression 20.84 10.24 8 45927 136 29528456
Blood pressure increased 20.70 10.24 190 45745 73613 29454979
Inappropriate schedule of product administration 20.69 10.24 129 45806 44343 29484249
Product use in unapproved indication 20.63 10.24 216 45719 86659 29441933
Activated partial thromboplastin time shortened 20.46 10.24 11 45924 420 29528172
White blood cell count decreased 20.43 10.24 64 45871 83298 29445294
Oxygen saturation decreased 20.07 10.24 129 45806 44808 29483784
Retinal ischaemia 20.05 10.24 10 45925 326 29528266
Respiratory disorder 20.02 10.24 65 45870 16918 29511674
Graft versus host disease in gastrointestinal tract 20.00 10.24 25 45910 3233 29525359
Gastrointestinal inflammation 19.95 10.24 24 45911 2984 29525608
Relapsing fever 19.93 10.24 8 45927 154 29528438
Neutrophil count decreased 19.87 10.24 23 45912 43544 29485048
Anaemia 19.82 10.24 208 45727 200743 29327849
Skin striae 19.81 10.24 11 45924 448 29528144
Rotavirus infection 19.59 10.24 10 45925 343 29528249
Penile erythema 19.46 10.24 8 45927 164 29528428
Emphysema 19.25 10.24 42 45893 8629 29519963
Cerebral microangiopathy 19.24 10.24 8 45927 169 29528423
Drug ineffective 19.09 10.24 716 45219 362454 29166138
Blood pressure fluctuation 18.99 10.24 71 45864 19823 29508769
Rash erythematous 18.98 10.24 75 45860 21487 29507105
Ear infection 18.86 10.24 40 45895 8060 29520532
Rhinovirus infection 18.67 10.24 24 45911 3192 29525400
Blood pressure systolic increased 18.54 10.24 63 45872 16782 29511810
Gastrointestinal wall thickening 18.50 10.24 15 45920 1153 29527439
Crohn's disease 18.33 10.24 23 45912 2986 29525606
Osteoporosis 18.30 10.24 47 45888 10722 29517870
Oedema mouth 18.14 10.24 15 45920 1186 29527406
CADASIL 17.93 10.24 6 45929 67 29528525
Rhonchi 17.84 10.24 17 45918 1621 29526971
Carotid arteriosclerosis 17.74 10.24 16 45919 1422 29527170
Intestinal obstruction 17.74 10.24 68 45867 19209 29509383
Electrocardiogram QT prolonged 17.67 10.24 18 45917 36119 29492473
Magnetic resonance imaging spinal abnormal 17.61 10.24 6 45929 71 29528521
Tracheal haemorrhage 17.54 10.24 10 45925 429 29528163
Drug level below therapeutic 17.54 10.24 27 45908 4244 29524348
Nephrectomy 17.48 10.24 12 45923 716 29527876
Varicella zoster virus infection 17.46 10.24 16 45919 1452 29527140
Visual evoked potentials abnormal 17.24 10.24 6 45929 76 29528516
Nasal turbinate hypertrophy 17.10 10.24 6 45929 78 29528514
Blood creatinine increased 17.10 10.24 71 45864 85031 29443561
Adrenocortical insufficiency acute 16.90 10.24 15 45920 1305 29527287
Pouchitis 16.87 10.24 11 45924 602 29527990
Anosmia 16.80 10.24 18 45917 1973 29526619
Cataract 16.69 10.24 74 45861 22304 29506288
Suicide attempt 16.67 10.24 17 45918 34093 29494499
Pulmonary function test decreased 16.65 10.24 26 45909 4137 29524455
Increased upper airway secretion 16.57 10.24 16 45919 1550 29527042
Reversible airways obstruction 16.56 10.24 8 45927 243 29528349
Nausea 16.39 10.24 334 45601 288921 29239671
Adrenal cortex necrosis 16.35 10.24 4 45931 12 29528580
Mucosal inflammation 16.31 10.24 15 45920 31580 29497012
Pharyngitis streptococcal 16.27 10.24 18 45917 2046 29526546
Product quality issue 16.24 10.24 58 45877 15837 29512755
Anaphylactic reaction 16.11 10.24 85 45850 27488 29501104
Hypercapnic coma 16.09 10.24 7 45928 166 29528426
Bronchopulmonary aspergillosis allergic 16.01 10.24 10 45925 508 29528084
Growth retardation 15.98 10.24 16 45919 1620 29526972
Cardiogenic shock 15.89 10.24 5 45930 19185 29509407
Dysbiosis 15.72 10.24 9 45926 389 29528203
Delirium 15.70 10.24 23 45912 39374 29489218
Central nervous system inflammation 15.69 10.24 6 45929 101 29528491
Psychotic disorder 15.65 10.24 6 45929 20348 29508244
Factor V Leiden mutation 15.62 10.24 5 45930 48 29528544
Respiration abnormal 15.56 10.24 20 45915 2660 29525932
Full blood count decreased 15.50 10.24 3 45932 15989 29512603
Stomatitis 15.45 10.24 21 45914 37092 29491500
Status asthmaticus 15.42 10.24 8 45927 284 29528308
Leukopenia 15.27 10.24 40 45895 55163 29473429
Haematochezia 15.20 10.24 104 45831 36879 29491713
Sepsis 15.17 10.24 145 45790 142537 29386055
Defaecation urgency 15.09 10.24 16 45919 1733 29526859
Intentional product use issue 14.88 10.24 115 45820 42383 29486209
Respiratory syncytial virus infection 14.84 10.24 23 45912 3636 29524956
Drug reaction with eosinophilia and systemic symptoms 14.79 10.24 13 45922 27979 29500613
Product substitution error 14.74 10.24 4 45931 20 29528572
Peak expiratory flow rate decreased 14.73 10.24 6 45929 120 29528472
Hypoventilation 14.64 10.24 20 45915 2821 29525771
Necrotising retinitis 14.63 10.24 11 45924 757 29527835
Hypercapnia 14.53 10.24 23 45912 3703 29524889
Eosinophilic oesophagitis 14.51 10.24 7 45928 212 29528380
Short-bowel syndrome 14.45 10.24 7 45928 214 29528378
Dysarthria 14.44 10.24 16 45919 30895 29497697
Rubber sensitivity 14.42 10.24 6 45929 127 29528465
Laryngeal cryptococcosis 14.33 10.24 3 45932 3 29528589
Precursor B-lymphoblastic lymphoma 14.33 10.24 3 45932 3 29528589
Bronchial obstruction 14.32 10.24 14 45921 1377 29527215
Saccadic eye movement 14.29 10.24 6 45929 130 29528462
Gastroenteritis clostridial 14.24 10.24 7 45928 221 29528371
Urinary tract infection 14.14 10.24 61 45874 72293 29456299
Abdominal abscess 14.08 10.24 23 45912 3801 29524791
Rhabdomyolysis 13.98 10.24 48 45887 60760 29467832
Therapeutic response shortened 13.97 10.24 26 45909 4765 29523827
Somnolence 13.97 10.24 87 45848 93868 29434724
Nocardiosis 13.94 10.24 21 45914 3239 29525353
Influenza 13.93 10.24 112 45823 41769 29486823
Necrotising ulcerative gingivostomatitis 13.91 10.24 5 45930 70 29528522
Cerebral artery embolism 13.87 10.24 11 45924 819 29527773
Cortisol decreased 13.86 10.24 11 45924 820 29527772
Aspergillus infection 13.85 10.24 42 45893 10539 29518053
Nasal disorder 13.84 10.24 14 45921 1435 29527157
Dermatitis contact 13.84 10.24 20 45915 2972 29525620
Obstruction 13.82 10.24 16 45919 1910 29526682
Abdominal adhesions 13.74 10.24 13 45922 1228 29527364
Cardio-respiratory arrest 13.74 10.24 37 45898 50564 29478028
Serotonin syndrome 13.74 10.24 5 45930 17507 29511085
Drug level above therapeutic 13.70 10.24 21 45914 3289 29525303
Cytomegalovirus colitis 13.67 10.24 18 45917 2451 29526141
Body temperature decreased 13.65 10.24 42 45893 10622 29517970
Oropharyngeal pain 13.65 10.24 85 45850 29200 29499392
Bacterial toxaemia 13.61 10.24 6 45929 147 29528445
Confusional state 13.57 10.24 130 45805 127747 29400845
Throat irritation 13.56 10.24 37 45898 8748 29519844
Plasma cell myeloma 13.53 10.24 23 45912 37092 29491500
Cystic fibrosis 13.50 10.24 14 45921 1478 29527114
Respiratory tract congestion 13.49 10.24 27 45908 5222 29523370
Foreign body aspiration 13.32 10.24 6 45929 155 29528437
Pneumonia adenoviral 13.28 10.24 6 45929 156 29528436
Small airways disease 13.25 10.24 4 45931 31 29528561
Gastrointestinal mucosa hyperaemia 13.25 10.24 7 45928 258 29528334
Congenital hydronephrosis 13.24 10.24 10 45925 693 29527899
Acute respiratory failure 13.17 10.24 78 45857 26324 29502268
Oesophageal carcinoma recurrent 13.12 10.24 3 45932 6 29528586
Astrovirus test positive 13.12 10.24 3 45932 6 29528586
Rhinorrhoea 13.03 10.24 67 45868 21452 29507140
Constipation 13.00 10.24 114 45821 114046 29414546
Complicated appendicitis 12.92 10.24 4 45931 34 29528558
Pancreatic cyst 12.81 10.24 10 45925 728 29527864
Sleep disorder 12.79 10.24 73 45862 24313 29504279
Sinus operation 12.77 10.24 9 45926 560 29528032
Product monitoring error 12.70 10.24 18 45917 2627 29525965
Asthmatic crisis 12.69 10.24 8 45927 413 29528179
Product administered to patient of inappropriate age 12.65 10.24 18 45917 2637 29525955
Pulmonary oedema 12.57 10.24 30 45905 42705 29485887
Bronchial disorder 12.55 10.24 12 45923 1149 29527443
Secretion discharge 12.47 10.24 23 45912 4187 29524405
Double stranded DNA antibody positive 12.40 10.24 6 45929 183 29528409
Overdose 12.34 10.24 73 45862 79746 29448846
Proctalgia 12.33 10.24 23 45912 4222 29524370
Liver disorder 12.28 10.24 15 45920 27734 29500858
Stoma site abscess 12.26 10.24 4 45931 41 29528551
Sputum increased 12.17 10.24 15 45920 1912 29526680
Coma 12.16 10.24 27 45908 39423 29489169
Lipid metabolism disorder 12.14 10.24 7 45928 307 29528285
Tachypnoea 12.05 10.24 51 45884 15064 29513528
Neuroleptic malignant syndrome 12.02 10.24 5 45930 16143 29512449
Graft versus host disease in skin 12.01 10.24 20 45915 3359 29525233
Psoriatic arthropathy 11.86 10.24 4 45931 14687 29513905
Cardiac arrest 11.84 10.24 81 45854 85510 29443082
Septic embolus 11.63 10.24 11 45924 1039 29527553
Bacterial diarrhoea 11.62 10.24 4 45931 49 29528543
Plantar erythema 11.54 10.24 4 45931 50 29528542
Cor pulmonale chronic 11.54 10.24 4 45931 50 29528542
Bone marrow oedema 11.48 10.24 8 45927 489 29528103
Cholangitis sclerosing 11.48 10.24 11 45924 1056 29527536
Seminoma 11.41 10.24 6 45929 219 29528373
Renal impairment 11.23 10.24 77 45858 81256 29447336
Lung abscess 11.21 10.24 16 45919 2350 29526242
Increased bronchial secretion 11.12 10.24 13 45922 1568 29527024
Respiratory syncytial virus bronchiolitis 11.07 10.24 7 45928 363 29528229
Cerebrovascular accident 11.03 10.24 72 45863 76839 29451753
White coat hypertension 11.00 10.24 4 45931 58 29528534
Haemoptysis 10.87 10.24 83 45852 30467 29498125
Middle insomnia 10.84 10.24 26 45909 5682 29522910
Upper respiratory fungal infection 10.83 10.24 5 45930 137 29528455
Primary myelofibrosis 10.82 10.24 4 45931 61 29528531
Pharyngeal oedema 10.77 10.24 26 45909 5708 29522884
Kidney infection 10.76 10.24 23 45912 4660 29523932
Gastrointestinal polyp 10.74 10.24 3 45932 17 29528575
Anal stenosis 10.73 10.24 5 45930 140 29528452
Paranasal sinus mucosal hypertrophy 10.64 10.24 4 45931 64 29528528
Catheter site related reaction 10.62 10.24 6 45929 253 29528339
Pseudomonas infection 10.58 10.24 39 45896 10813 29517779
Rectal abscess 10.58 10.24 10 45925 944 29527648
Middle ear effusion 10.56 10.24 8 45927 557 29528035
Abscess intestinal 10.44 10.24 12 45923 1422 29527170
Hepatic function abnormal 10.44 10.24 29 45906 39230 29489362
Device malfunction 10.42 10.24 33 45902 8474 29520118
Diabetic ketoacidosis 10.41 10.24 6 45929 16067 29512525
Chronic kidney disease 10.36 10.24 26 45909 36390 29492202
Respiratory failure 10.36 10.24 210 45725 96921 29431671
Leukoplakia oral 10.31 10.24 4 45931 70 29528522
Wound decomposition 10.31 10.24 4 45931 70 29528522
Palmar-plantar erythrodysaesthesia syndrome 10.31 10.24 5 45930 14754 29513838
Poor venous access 10.30 10.24 18 45917 3143 29525449
Physical examination abnormal 10.28 10.24 6 45929 269 29528323
Coeliac disease 10.28 10.24 8 45927 580 29528012
Gastrooesophageal sphincter insufficiency 10.26 10.24 4 45931 71 29528521

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 1732.31 9.76 1347 103202 93878 64300305
Wheezing 773.58 9.76 795 103754 79784 64314399
Dyspnoea 601.42 9.76 2524 102025 716150 63678033
Cough 419.44 9.76 1256 103293 300892 64093291
Obstructive airways disorder 411.94 9.76 324 104225 22861 64371322
Chest discomfort 319.10 9.76 629 103920 115477 64278706
Completed suicide 264.50 9.76 28 104521 224386 64169797
Toxicity to various agents 253.36 9.76 137 104412 363376 64030807
Full blood count abnormal 228.14 9.76 261 104288 29496 64364687
Colitis ulcerative 227.55 9.76 231 104318 22797 64371386
Productive cough 218.67 9.76 411 104138 72792 64321391
Sleep disorder due to a general medical condition 200.13 9.76 139 104410 8095 64386088
Chronic obstructive pulmonary disease 184.38 9.76 376 104173 70672 64323511
Nasal polyps 166.90 9.76 92 104457 3537 64390646
Drug abuse 154.66 9.76 17 104532 132357 64261826
Eosinophilic granulomatosis with polyangiitis 140.68 9.76 76 104473 2806 64391377
Frequent bowel movements 129.35 9.76 154 104395 18151 64376032
Acute kidney injury 126.93 9.76 344 104205 448896 63945287
Sputum discoloured 124.16 9.76 149 104400 17707 64376476
Chronic sinusitis 118.39 9.76 91 104458 6201 64387982
Bronchospasm 116.22 9.76 159 104390 21523 64372660
Upper-airway cough syndrome 115.23 9.76 103 104446 8667 64385516
Blood immunoglobulin E increased 112.90 9.76 73 104476 3771 64390412
Pneumonia 111.09 9.76 1389 103160 558187 63835996
Contraindicated product administered 107.30 9.76 22 104527 107807 64286376
Forced expiratory volume decreased 107.18 9.76 89 104460 6778 64387405
Eosinophil count increased 106.83 9.76 123 104426 13989 64380194
Bronchiectasis 106.63 9.76 123 104426 14017 64380166
Respiratory symptom 104.79 9.76 64 104485 2989 64391194
Blood test abnormal 103.39 9.76 116 104433 12827 64381356
Gastrooesophageal reflux disease 102.28 9.76 332 104217 82811 64311372
Febrile neutropenia 101.19 9.76 93 104456 187564 64206619
Neutropenia 94.08 9.76 152 104397 239472 64154711
Loss of personal independence in daily activities 93.37 9.76 294 104255 72160 64322023
Polycystic ovaries 91.93 9.76 52 104497 2103 64392080
Heart rate increased 90.57 9.76 358 104191 98317 64295866
Asthmatic crisis 90.46 9.76 48 104501 1708 64392475
Weight decreased 89.14 9.76 778 103771 284961 64109222
Growth failure 89.00 9.76 27 104522 203 64393980
Middle insomnia 82.32 9.76 103 104446 12774 64381409
Hand deformity 78.81 9.76 6 104543 62765 64331418
Off label use 78.18 9.76 1449 103100 631357 63762826
Death 75.95 9.76 465 104084 482240 63911943
Reversible airways obstruction 75.80 9.76 37 104512 1101 64393082
Synovitis 75.47 9.76 33 104516 99057 64295126
Labile blood pressure 74.99 9.76 45 104504 2035 64392148
Faecal calprotectin increased 73.69 9.76 55 104494 3585 64390598
Systemic lupus erythematosus 72.86 9.76 18 104531 77594 64316589
Dust allergy 72.44 9.76 35 104514 1018 64393165
Dyspnoea exertional 72.14 9.76 273 104276 73457 64320726
Intentional overdose 71.66 9.76 28 104521 89916 64304267
Cushingoid 70.99 9.76 74 104475 7529 64386654
Bronchial secretion retention 69.36 9.76 46 104503 2481 64391702
Respiratory tract infection 69.07 9.76 173 104376 37234 64356949
Thrombocytopenia 68.76 9.76 164 104385 223637 64170546
Therapeutic product effect incomplete 68.10 9.76 340 104209 103142 64291041
Breath sounds abnormal 67.77 9.76 89 104460 11580 64382603
Nasal congestion 66.07 9.76 230 104319 59428 64334755
Sleep apnoea syndrome 65.96 9.76 148 104401 29684 64364499
Upper respiratory fungal infection 65.67 9.76 23 104526 284 64393899
Rhinitis allergic 65.55 9.76 73 104476 8005 64386178
Eosinophilic bronchitis 64.83 9.76 24 104525 351 64393832
White blood cell count decreased 62.97 9.76 99 104450 157738 64236445
Platelet count decreased 62.45 9.76 110 104439 167601 64226582
Sinusitis fungal 61.74 9.76 37 104512 1669 64392514
Alopecia 60.50 9.76 110 104439 165580 64228603
Gastrointestinal wall thickening 59.43 9.76 39 104510 2066 64392117
Adrenal suppression 59.27 9.76 33 104516 1294 64392889
Sensitisation 58.68 9.76 36 104513 1695 64392488
Blood pressure increased 58.59 9.76 479 104070 172073 64222110
Vital capacity decreased 57.20 9.76 30 104519 1042 64393141
Condition aggravated 56.84 9.76 883 103666 371543 64022640
Hyper IgE syndrome 54.99 9.76 23 104526 472 64393711
Fall 54.87 9.76 423 104126 416403 63977780
Cushing's syndrome 54.73 9.76 28 104521 923 64393260
Pericarditis 54.02 9.76 17 104532 62499 64331684
Malignant neoplasm progression 53.94 9.76 62 104487 112809 64281374
Arthropathy 52.02 9.76 72 104477 120895 64273288
Hepatic enzyme increased 50.41 9.76 83 104466 129860 64264323
Anaphylactic reaction 49.78 9.76 232 104317 68432 64325751
Peak expiratory flow rate decreased 49.73 9.76 23 104526 605 64393578
Infective pulmonary exacerbation of cystic fibrosis 49.40 9.76 77 104472 11719 64382464
Anosmia 48.61 9.76 47 104502 4370 64389813
Spirometry abnormal 48.45 9.76 22 104527 554 64393629
Rheumatoid arthritis 48.40 9.76 123 104426 164171 64230012
Stomatitis 48.38 9.76 64 104485 109541 64284642
Sputum increased 48.37 9.76 43 104506 3592 64390591
Salpingo-oophorectomy unilateral 48.32 9.76 21 104528 475 64393708
Graft versus host disease 48.16 9.76 83 104466 13730 64380453
Joint swelling 48.05 9.76 183 104366 215199 64178984
Mucosal inflammation 47.40 9.76 21 104528 62563 64331620
Pancytopenia 47.26 9.76 101 104448 143208 64250975
Emphysema 47.05 9.76 83 104466 13986 64380197
Intestinal stenosis 46.75 9.76 40 104509 3174 64391009
Impaired quality of life 46.63 9.76 55 104494 6416 64387767
Butterfly rash 46.35 9.76 27 104522 1155 64393028
Lung diffusion test abnormal 46.03 9.76 15 104534 146 64394037
Hypotension 45.82 9.76 396 104153 380578 64013605
Ileal stenosis 45.51 9.76 33 104516 2057 64392126
Aspergillus infection 45.23 9.76 89 104460 16290 64377893
Mycotic allergy 45.07 9.76 25 104524 973 64393210
Cystic fibrosis 44.46 9.76 40 104509 3394 64390789
Graft versus host disease in gastrointestinal tract 44.31 9.76 50 104499 5562 64388621
Treatment failure 44.04 9.76 76 104473 116740 64277443
Overdose 43.57 9.76 124 104425 159442 64234741
Neutrophil count decreased 43.09 9.76 37 104512 77159 64317024
Female genital tract fistula 42.63 9.76 35 104514 2623 64391560
Systemic mycosis 42.40 9.76 33 104516 2290 64391893
Dysphonia 42.30 9.76 168 104381 46214 64347969
Coma 41.99 9.76 48 104501 87567 64306616
Ejection fraction 41.70 9.76 26 104523 1260 64392923
Duodenal ulcer perforation 41.57 9.76 4 104545 34621 64359562
Ventricular failure 41.28 9.76 19 104530 494 64393689
Glossodynia 41.26 9.76 27 104522 64669 64329514
Multiple allergies 41.21 9.76 49 104500 5765 64388418
Respiration abnormal 41.14 9.76 51 104498 6264 64387919
Dyspnoea at rest 41.05 9.76 51 104498 6278 64387905
Therapeutic reaction time decreased 40.92 9.76 30 104519 1902 64392281
Eosinophilia 40.60 9.76 145 104404 37931 64356252
Rhonchi 40.29 9.76 38 104511 3425 64390758
Mucous stools 40.17 9.76 37 104512 3236 64390947
Helicobacter infection 39.91 9.76 7 104542 38355 64355828
Sinusitis 39.68 9.76 386 104163 145542 64248641
Asphyxia 39.44 9.76 62 104487 9504 64384679
Confusional state 39.20 9.76 255 104294 260889 64133294
Intestinal obstruction 38.54 9.76 138 104411 36148 64358035
Bronchopulmonary aspergillosis allergic 38.52 9.76 27 104522 1595 64392588
Cyanosis 38.34 9.76 100 104449 22055 64372128
Pain 38.32 9.76 649 103900 552862 63841321
Disease progression 38.02 9.76 111 104438 141569 64252614
Swelling 37.78 9.76 133 104416 160085 64234098
Intestinal fistula 37.73 9.76 24 104525 1205 64392978
Impaired healing 37.54 9.76 26 104523 60447 64333736
Lung disorder 36.83 9.76 195 104354 60505 64333678
Respiratory distress 36.60 9.76 175 104374 52156 64342027
Hepatic ischaemia 36.56 9.76 22 104527 1000 64393183
Adrenal insufficiency 36.39 9.76 99 104450 22388 64371795
Somnolence 36.36 9.76 188 104361 203457 64190726
Cardio-respiratory arrest 36.19 9.76 65 104484 98328 64295855
Embolism venous 36.14 9.76 36 104513 3471 64390712
Colitis 35.94 9.76 189 104360 58485 64335698
Drug intolerance 35.60 9.76 170 104379 187822 64206361
Anaemia 35.02 9.76 419 104130 378261 64015922
Bronchomalacia 33.99 9.76 13 104536 209 64393974
Eosinophilic oesophagitis 33.67 9.76 16 104533 448 64393735
Oropharyngeal pain 33.61 9.76 253 104296 88614 64305569
Drug level below therapeutic 33.46 9.76 50 104499 7334 64386849
Rhinorrhoea 33.25 9.76 188 104361 59781 64334402
Intentional self-injury 33.23 9.76 4 104545 29040 64365143
Muscle relaxant therapy 33.16 9.76 12 104537 164 64394019
Rheumatoid factor positive 32.99 9.76 8 104541 34930 64359253
Sinus operation 32.95 9.76 25 104524 1670 64392513
Polyp 32.87 9.76 47 104502 6626 64387557
Bronchitis 32.74 9.76 294 104255 108449 64285734
Throat irritation 32.71 9.76 122 104427 32589 64361594
Mite allergy 32.34 9.76 18 104531 705 64393478
Herpes simplex oesophagitis 31.90 9.76 13 104536 249 64393934
Suicide attempt 31.80 9.76 41 104508 70966 64323217
Sopor 31.77 9.76 5 104544 29656 64364527
Nausea 31.66 9.76 1002 103547 784798 63609385
Eczema 31.53 9.76 113 104436 29607 64364576
Upper respiratory tract infection 31.45 9.76 214 104335 72571 64321612
Conjunctivitis allergic 31.33 9.76 20 104529 1010 64393173
Pulmonary function test decreased 31.08 9.76 45 104504 6416 64387767
Obstruction 31.02 9.76 32 104517 3216 64390967
Ascites 30.77 9.76 33 104516 61968 64332215
Increased upper airway secretion 30.57 9.76 33 104516 3494 64390689
Total lung capacity decreased 30.43 9.76 24 104525 1698 64392485
Colitis microscopic 30.41 9.76 48 104501 7384 64386799
Drug specific antibody 30.32 9.76 26 104523 2069 64392114
Hypothyroidism 30.28 9.76 138 104411 40319 64353864
Nephrectomy 29.94 9.76 22 104527 1400 64392783
Restrictive pulmonary disease 29.51 9.76 26 104523 2146 64392037
Apoptosis 29.32 9.76 13 104536 309 64393874
Blister 29.32 9.76 54 104495 80913 64313270
Sputum culture positive 29.24 9.76 30 104519 2996 64391187
Sepsis 29.20 9.76 236 104313 230105 64164078
Neoplasm progression 29.10 9.76 15 104534 40949 64353234
Sinus disorder 28.93 9.76 76 104473 16832 64377351
Respiratory tract inflammation 28.24 9.76 17 104532 773 64393410
Bronchiolitis 28 9.76 32 104517 3609 64390574
Abdominal pain 27.90 9.76 683 103866 311692 64082491
Psoriatic arthropathy 27.68 9.76 18 104531 43263 64350920
Respiratory disorder 27.64 9.76 124 104425 35987 64358196
Pouchitis 27.58 9.76 17 104532 807 64393376
Hiatus hernia 27.57 9.76 83 104466 19874 64374309
Status asthmaticus 27.49 9.76 18 104531 950 64393233
Leukopenia 27.39 9.76 79 104470 101163 64293020
Pseudomonas infection 27.22 9.76 77 104472 17806 64376377
Frustration tolerance decreased 27.08 9.76 41 104508 6084 64388099
Renal impairment 26.79 9.76 120 104429 134897 64259286
Circumstance or information capable of leading to medication error 26.78 9.76 30 104519 3310 64390873
Haemoptysis 26.69 9.76 153 104396 48895 64345288
Rales 26.62 9.76 69 104480 15160 64379023
Allergy to animal 26.62 9.76 18 104531 1003 64393180
Throat clearing 26.60 9.76 20 104529 1318 64392865
Hyponatraemia 26.43 9.76 137 104412 148202 64245981
Neurotoxicity 26.42 9.76 6 104543 27398 64366785
Osteoporosis 26.08 9.76 136 104413 41944 64352239
Growth retardation 25.97 9.76 21 104528 1540 64392643
Weight gain poor 25.95 9.76 16 104533 760 64393423
Vocal cord dysfunction 25.88 9.76 13 104536 412 64393771
Inappropriate schedule of product administration 25.51 9.76 245 104304 92041 64302142
Sedation 25.51 9.76 18 104531 41444 64352739
Intentional device misuse 25.43 9.76 15 104534 657 64393526
Laryngeal stenosis 25.37 9.76 16 104533 791 64393392
Pulmonary mass 25.21 9.76 91 104458 23925 64370258
Herpes zoster meningoencephalitis 25.06 9.76 15 104534 675 64393508
Respiratory tract congestion 25.00 9.76 70 104479 16095 64378088
Decreased appetite 24.93 9.76 314 104235 280975 64113208
Night sweats 24.81 9.76 120 104429 35926 64358257
Bacterial disease carrier 24.59 9.76 17 104532 982 64393201
Rhinitis 24.46 9.76 54 104495 10711 64383472
Lower respiratory tract infection 24.12 9.76 247 104302 94367 64299816
Product quality issue 24.08 9.76 104 104445 29695 64364488
Lung diffusion test decreased 24.05 9.76 18 104531 1178 64393005
Oropharyngeal discomfort 24.00 9.76 36 104513 5299 64388884
Palpitations 23.94 9.76 267 104282 104221 64289962
Multiple sclerosis relapse 23.84 9.76 19 104530 41116 64353067
Increased bronchial secretion 23.60 9.76 26 104523 2816 64391367
Delayed puberty 23.52 9.76 9 104540 145 64394038
Wound 23.49 9.76 56 104493 76421 64317762
Abdominal discomfort 23.47 9.76 186 104363 182136 64212047
Encephalopathy 23.34 9.76 37 104512 58782 64335401
Mycobacterium test positive 23.28 9.76 12 104537 402 64393781
Venous pressure jugular increased 23.18 9.76 18 104531 1245 64392938
Proctitis 23.01 9.76 27 104522 3132 64391051
Folliculitis 22.92 9.76 10 104539 30067 64364116
Product use in unapproved indication 22.55 9.76 407 104142 176211 64217972
Graft versus host disease in skin 22.52 9.76 35 104514 5312 64388871
Tachypnoea 22.45 9.76 94 104455 26477 64367706
Electrocardiogram QT prolonged 22.22 9.76 61 104488 79387 64314796
Eye swelling 22.19 9.76 83 104466 22198 64371985
Periumbilical abscess 22.17 9.76 7 104542 61 64394122
Nasal obstruction 22.02 9.76 18 104531 1341 64392842
Intestinal resection 21.98 9.76 26 104523 3042 64391141
Procedural pneumothorax 21.87 9.76 7 104542 64 64394119
Botulism 21.86 9.76 11 104538 350 64393833
Haematochezia 21.82 9.76 183 104366 66190 64327993
Secretion discharge 21.73 9.76 55 104494 11909 64382274
Sensitivity to weather change 21.67 9.76 39 104510 6675 64387508
Body temperature decreased 21.34 9.76 91 104458 25837 64368346
Lactic acidosis 21.32 9.76 42 104507 61368 64332815
Plasma cell myeloma 21.26 9.76 26 104523 46049 64348134
Throat tightness 21.20 9.76 84 104465 23076 64371107
Blood creatinine increased 21.16 9.76 131 104418 135651 64258532
Bradycardia 21.16 9.76 109 104440 118110 64276073
Defaecation urgency 20.99 9.76 29 104520 3960 64390223
Therapeutic response shortened 20.87 9.76 49 104500 10121 64384062
Hypoventilation 20.82 9.76 36 104513 5970 64388213
Endometriosis 20.57 9.76 24 104525 2768 64391415
Drug hypersensitivity 20.50 9.76 267 104282 237548 64156635
Rhabdomyolysis 20.39 9.76 78 104471 91648 64302535
Pulmonary artery stenosis congenital 20.23 9.76 5 104544 15 64394168
Product use issue 20.21 9.76 352 104197 151363 64242820
Delirium 20.21 9.76 52 104497 69142 64325041
Bronchial obstruction 20.21 9.76 22 104527 2352 64391831
Sinus congestion 20.20 9.76 63 104486 15376 64378807
Infusion related reaction 20.15 9.76 170 104379 164297 64229886
Aspirin-exacerbated respiratory disease 20.14 9.76 16 104533 1144 64393039
Laryngeal oedema 20.06 9.76 39 104510 7074 64387109
Cytomegalovirus colitis 19.84 9.76 28 104521 3900 64390283
Viral infection 19.83 9.76 113 104436 36027 64358156
Infective exacerbation of chronic obstructive airways disease 19.72 9.76 22 104527 2416 64391767
Eye infection fungal 19.55 9.76 11 104538 440 64393743
Nasopharyngitis 19.41 9.76 435 104114 195638 64198545
Tumour lysis syndrome 19.26 9.76 4 104545 19436 64374747
Cytokine release syndrome 19.22 9.76 5 104544 20824 64373359
Musculoskeletal stiffness 19.13 9.76 119 104430 123087 64271096
Pharyngeal oedema 19.06 9.76 62 104487 15469 64378714
Vomiting 19.05 9.76 716 103833 550401 63843782
Periorbital oedema 18.93 9.76 39 104510 7375 64386808
Respiratory rate increased 18.85 9.76 69 104480 18262 64375921
Poisoning 18.81 9.76 6 104543 21873 64372310
Metabolic acidosis 18.73 9.76 56 104493 70902 64323281
Haemoglobin decreased 18.70 9.76 214 104335 194849 64199334
Peripheral swelling 18.70 9.76 233 104316 208920 64185263
Smoke sensitivity 18.69 9.76 11 104538 480 64393703
Abscess intestinal 18.59 9.76 21 104528 2339 64391844
Otorrhoea 18.52 9.76 17 104532 1480 64392703
Activated partial thromboplastin time shortened 18.49 9.76 13 104536 772 64393411
Drug level above therapeutic 18.45 9.76 37 104512 6864 64387319
Kyphosis 18.35 9.76 21 104528 2372 64391811
Rectal prolapse 18.31 9.76 18 104531 1708 64392475
Osteomyelitis 18.30 9.76 11 104538 27576 64366607
Myelodysplastic syndrome 18.29 9.76 11 104538 27568 64366615
Hepatic function abnormal 18.27 9.76 49 104500 64264 64329919
Hip arthroplasty 18.10 9.76 6 104543 21345 64372838
Nasal discharge discolouration 18.06 9.76 18 104531 1736 64392447
Atypical mycobacterium test positive 18.05 9.76 4 104545 6 64394177
Drug specific antibody present 18.00 9.76 31 104518 5123 64389060
Hypothalamic pituitary adrenal axis suppression 17.92 9.76 9 104540 285 64393898
Hepatorenal syndrome 17.89 9.76 26 104523 3720 64390463
Ligament pain 17.86 9.76 8 104541 195 64393988
Swollen tongue 17.70 9.76 107 104442 34847 64359336
Cardiac arrest 17.66 9.76 162 104387 153902 64240281
Accidental overdose 17.63 9.76 17 104532 33540 64360643
Steroid dependence 17.57 9.76 10 104539 409 64393774
Catarrh 17.53 9.76 11 104538 539 64393644
Infusion site extravasation 17.50 9.76 36 104513 6801 64387382
Tracheostomy infection 17.29 9.76 6 104543 72 64394111
Abdominal abscess 17.10 9.76 34 104515 6270 64387913
Dysarthria 17.07 9.76 45 104504 59361 64334822
Dermatitis contact 17.00 9.76 42 104507 8958 64385225
Drug level decreased 16.99 9.76 49 104500 11454 64382729
Cortisol decreased 16.88 9.76 17 104532 1660 64392523
Bronchitis bacterial 16.88 9.76 15 104534 1252 64392931
Oedema mouth 16.82 9.76 22 104527 2851 64391332
Penile erythema 16.81 9.76 7 104542 142 64394041
Sleep disorder due to general medical condition, insomnia type 16.70 9.76 11 104538 26259 64367924
Tracheitis 16.65 9.76 15 104534 1275 64392908
Cerebrovascular accident 16.50 9.76 143 104406 137440 64256743
Bone marrow failure 16.47 9.76 33 104516 47919 64346264
Candida infection 16.44 9.76 97 104452 31322 64362861
Large intestinal stenosis 16.39 9.76 20 104529 2417 64391766
White coat hypertension 16.26 9.76 10 104539 473 64393710
Bacterial toxaemia 16.20 9.76 7 104542 156 64394027
Device expulsion 16.15 9.76 7 104542 21129 64373054
Malaise 16.13 9.76 791 103758 395456 63998727
Fungal oesophagitis 16.01 9.76 12 104537 787 64393396
Blood pressure fluctuation 15.99 9.76 141 104408 51730 64342453
Mitochondrial neurogastrointestinal encephalopathy 15.94 9.76 4 104545 13 64394170
Swelling face 15.82 9.76 156 104393 59010 64335173
Aphonia 15.82 9.76 40 104509 8657 64385526
Varicella zoster virus infection 15.75 9.76 25 104524 3863 64390320
Hysterectomy 15.73 9.76 29 104520 5056 64389127
Perfume sensitivity 15.72 9.76 11 104538 648 64393535
Obstructive pancreatitis 15.66 9.76 11 104538 652 64393531
Nasal oedema 15.60 9.76 13 104536 995 64393188
Adrenocortical insufficiency acute 15.57 9.76 20 104529 2545 64391638
Neuropathy peripheral 15.53 9.76 119 104430 117406 64276777
Adrenal cortex necrosis 15.50 9.76 4 104545 15 64394168
Aphthous ulcer 15.37 9.76 51 104498 12855 64381328
Stridor 15.33 9.76 28 104521 4846 64389337
Sputum purulent 15.32 9.76 14 104535 1212 64392971
Cardiogenic shock 15.28 9.76 18 104531 32409 64361774
Type 2 diabetes mellitus 15.28 9.76 101 104448 33919 64360264
Sleep disorder 15.27 9.76 156 104393 59553 64334630
Nasal disorder 15.23 9.76 21 104528 2863 64391320
Rash 14.89 9.76 600 103949 457949 63936234
Liver disorder 14.89 9.76 41 104508 53310 64340873
Mobility decreased 14.88 9.76 80 104469 85760 64308423
Retinal ischaemia 14.85 9.76 11 104538 709 64393474
Pharyngeal hypoaesthesia 14.77 9.76 8 104541 297 64393886
Hyperplastic cholecystopathy 14.63 9.76 6 104543 117 64394066
Respiratory arrest 14.58 9.76 41 104508 52944 64341239
Feeling jittery 14.47 9.76 44 104505 10591 64383592
Bowel movement irregularity 14.40 9.76 27 104522 4766 64389417
Superinfection 14.40 9.76 24 104525 3862 64390321
Gastroenteritis norovirus 14.34 9.76 20 104529 2755 64391428
Myocardial infarction 14.34 9.76 186 104363 165635 64228548
Lip infection 14.26 9.76 6 104543 125 64394058
Incorrect dose administered 14.25 9.76 156 104393 60609 64333574
Laryngeal cryptococcosis 14.21 9.76 3 104546 3 64394180
Inflammatory bowel disease 14.19 9.76 26 104523 4512 64389671
Oligoarthritis 14.13 9.76 8 104541 324 64393859
Extrapyramidal disorder 14.12 9.76 7 104542 19545 64374638
Rotavirus infection 14.08 9.76 10 104539 603 64393580
Blood bilirubin increased 14.08 9.76 47 104502 57506 64336677
Depressed level of consciousness 14.06 9.76 76 104473 81360 64312823
Tooth discolouration 14.02 9.76 12 104537 953 64393230
Proctalgia 13.99 9.76 35 104514 7524 64386659
Type IV hypersensitivity reaction 13.86 9.76 22 104527 3400 64390783
Abscess 13.82 9.76 65 104484 19239 64374944
Norovirus infection 13.73 9.76 7 104542 229 64393954
Aspartate aminotransferase increased 13.70 9.76 126 104423 119662 64274521
Cryptosporidiosis infection 13.60 9.76 10 104539 637 64393546
Mental status changes 13.60 9.76 52 104497 61110 64333073
Blood cholesterol increased 13.58 9.76 39 104510 50027 64344156
Bulimia nervosa 13.56 9.76 7 104542 235 64393948
Influenza 13.41 9.76 245 104304 106286 64287897
Bronchial wall thickening 13.40 9.76 16 104533 1891 64392292
Hypersensitivity pneumonitis 13.40 9.76 21 104528 3211 64390972
Oxygen saturation decreased 13.32 9.76 246 104303 106930 64287253
Small intestinal stenosis 13.27 9.76 10 104539 661 64393522
Tremor 13.17 9.76 324 104225 147906 64246277
Red blood cell sedimentation rate abnormal 13.11 9.76 5 104544 16301 64377882
Rhinovirus infection 13.00 9.76 30 104519 6126 64388057
Astrovirus test positive 12.99 9.76 3 104546 6 64394177
Atopy 12.99 9.76 7 104542 257 64393926
Orthostatic hypotension 12.98 9.76 36 104513 46702 64347481
Sneezing 12.92 9.76 54 104495 15197 64378986
Hypercapnic coma 12.90 9.76 8 104541 384 64393799
Infrapatellar fat pad inflammation 12.86 9.76 6 104543 161 64394022
Posterior reversible encephalopathy syndrome 12.80 9.76 11 104538 22935 64371248
Drug reaction with eosinophilia and systemic symptoms 12.77 9.76 45 104504 54172 64340011
Pneumonia pseudomonal 12.77 9.76 26 104523 4877 64389306
Oesophageal candidiasis 12.68 9.76 35 104514 7982 64386201
Cardiac failure congestive 12.61 9.76 143 104406 130437 64263746
Miosis 12.60 9.76 3 104546 13263 64380920
Psychotic disorder 12.57 9.76 23 104526 34555 64359628
Blood pressure systolic increased 12.55 9.76 129 104420 49324 64344859
Gastrointestinal anastomotic leak 12.53 9.76 8 104541 404 64393779
Rectal abscess 12.51 9.76 14 104535 1543 64392640
Hepatotoxicity 12.48 9.76 29 104520 39933 64354250
Bronchopulmonary dysplasia 12.47 9.76 6 104543 173 64394010
Asthma-chronic obstructive pulmonary disease overlap syndrome 12.43 9.76 12 104537 1113 64393070
Nocturnal dyspnoea 12.42 9.76 13 104536 1329 64392854
Vocal cord disorder 12.41 9.76 13 104536 1330 64392853
Acquired diaphragmatic eventration 12.37 9.76 9 104540 564 64393619
Hypoglycaemia 12.36 9.76 90 104459 89802 64304381
Aural polyp 12.21 9.76 5 104544 97 64394086
Injury 12.19 9.76 48 104501 55944 64338239
Lung opacity 12.18 9.76 20 104529 3179 64391004
Alternaria infection 12.16 9.76 9 104540 579 64393604
Poor venous access 12.15 9.76 46 104503 12371 64381812
Acute myeloid leukaemia 12.15 9.76 16 104533 27447 64366736
Congenital hydronephrosis 12.14 9.76 3 104546 9 64394174
Ear infection 12.08 9.76 72 104477 23332 64370851
Acute myocardial infarction 12.07 9.76 65 104484 69653 64324530
Post viral fatigue syndrome 12.07 9.76 7 104542 297 64393886
Terminal insomnia 12.03 9.76 11 104538 953 64393230
Gastrointestinal polyp 12.00 9.76 4 104545 42 64394141
Product substitution error 12.00 9.76 4 104545 42 64394141
Seminoma 11.98 9.76 6 104543 189 64393994
Weight fluctuation 11.97 9.76 35 104514 8247 64385936
Infusion site swelling 11.95 9.76 27 104522 5438 64388745
Seasonal allergy 11.94 9.76 44 104505 11682 64382501
Urinary tract infection 11.92 9.76 285 104264 231311 64162872
Exposure to allergen 11.92 9.76 6 104543 191 64393992
Tracheal haemorrhage 11.92 9.76 9 104540 597 64393586
Stoma site abscess 11.86 9.76 6 104543 193 64393990
Oropharyngeal swelling 11.86 9.76 12 104537 1179 64393004
Hyperadrenocorticism 11.82 9.76 7 104542 309 64393874
Respiratory syncytial virus infection 11.76 9.76 32 104517 7236 64386947
Skin striae 11.73 9.76 13 104536 1417 64392766
Urticaria 11.63 9.76 317 104232 147000 64247183
Metastases to liver 11.59 9.76 13 104536 23928 64370255
Septic shock 11.59 9.76 112 104437 105325 64288858
Respiratory syncytial virus bronchiolitis 11.59 9.76 8 104541 461 64393722
Complex regional pain syndrome 11.54 9.76 14 104535 1682 64392501
Skin dystrophy 11.52 9.76 4 104545 48 64394135
Cognitive disorder 11.51 9.76 48 104501 55039 64339144
Distal intestinal obstruction syndrome 11.51 9.76 9 104540 629 64393554
Pertussis 11.50 9.76 10 104539 811 64393372
Complicated appendicitis 11.45 9.76 4 104545 49 64394134
Cross sensitivity reaction 11.43 9.76 20 104529 3347 64390836
Sprue-like enteropathy 11.42 9.76 11 104538 1018 64393165
Collateral circulation 11.38 9.76 4 104545 50 64394133
Axillary pain 11.30 9.76 14 104535 1718 64392465
Pleural effusion 11.30 9.76 141 104408 126418 64267765
Hyperkalaemia 11.30 9.76 107 104442 101022 64293161
Legionella test positive 11.28 9.76 3 104546 13 64394170
Alanine aminotransferase increased 11.28 9.76 158 104391 138873 64255310
Drug withdrawal syndrome 11.21 9.76 21 104528 31270 64362913
Oropharyngeal candidiasis 11.12 9.76 13 104536 1502 64392681
Necrotising retinitis 11.12 9.76 11 104538 1052 64393131
Tongue blistering 11.04 9.76 12 104537 1281 64392902
Coprolalia 11.03 9.76 4 104545 55 64394128
Pulmonary function test abnormal 11.01 9.76 19 104530 3145 64391038
Illness 11.01 9.76 67 104482 21871 64372312
Use of accessory respiratory muscles 10.98 9.76 7 104542 353 64393830
Relapsing fever 10.98 9.76 7 104542 353 64393830
Irritable bowel syndrome 10.97 9.76 28 104521 37341 64356842
Pneumonia aspiration 10.97 9.76 54 104495 59217 64334966
Device ineffective 10.90 9.76 5 104544 129 64394054
Neutropenic sepsis 10.88 9.76 13 104536 23259 64370924
Allergic respiratory disease 10.84 9.76 4 104545 58 64394125
Osteonecrosis of jaw 10.82 9.76 31 104518 39794 64354389
Toxic epidermal necrolysis 10.80 9.76 28 104521 37138 64357045
Perirectal abscess 10.79 9.76 14 104535 1799 64392384
Carotid arteriosclerosis 10.77 9.76 15 104534 2064 64392119
Gastrointestinal inflammation 10.76 9.76 28 104521 6167 64388016
Muscle spasms 10.72 9.76 302 104247 140721 64253462
Laryngitis fungal 10.69 9.76 5 104544 135 64394048
Campylobacter gastroenteritis 10.67 9.76 11 104538 1105 64393078
Lower respiratory tract congestion 10.59 9.76 18 104531 2943 64391240
Herpes zoster oticus 10.58 9.76 7 104542 376 64393807
Atelectasis 10.51 9.76 78 104471 27188 64366995
Granuloma 10.51 9.76 29 104520 6612 64387571
Cytopenia 10.50 9.76 6 104543 15465 64378718
Hypercalcaemia 10.46 9.76 22 104527 31394 64362789
Abdominal adhesions 10.46 9.76 18 104531 2974 64391209
Renal injury 10.45 9.76 6 104543 15423 64378760
Leukoplakia oral 10.42 9.76 6 104543 251 64393932
Bronchospasm paradoxical 10.39 9.76 5 104544 144 64394039
Sinusitis bacterial 10.39 9.76 11 104538 1139 64393044
Serotonin syndrome 10.37 9.76 31 104518 39251 64354932
Infective exacerbation of bronchiectasis 10.25 9.76 9 104540 739 64393444
Multiple organ dysfunction syndrome 10.21 9.76 110 104439 101303 64292880
Blood calcium decreased 10.21 9.76 16 104533 25538 64368645
Blood pressure systolic 10.20 9.76 4 104545 69 64394114
Akathisia 10.18 9.76 3 104546 11507 64382676
Nasal discomfort 10.16 9.76 22 104527 4306 64389877
Functional residual capacity decreased 10.15 9.76 4 104545 70 64394113
Pulseless electrical activity 10.09 9.76 4 104545 12735 64381448
Nervousness 9.98 9.76 82 104467 29474 64364709
Clostridium difficile infection 9.98 9.76 96 104453 36067 64358116
Tooth disorder 9.96 9.76 13 104536 22389 64371794
Diarrhoea 9.94 9.76 1023 103526 721681 63672502
Gastrointestinal mucosa hyperaemia 9.93 9.76 7 104542 417 64393766
Unevaluable event 9.93 9.76 45 104504 50444 64343739
Diverticulum 9.86 9.76 45 104504 13153 64381030
Adenovirus infection 9.86 9.76 30 104519 7225 64386958
Diabetic ketoacidosis 9.86 9.76 21 104528 29824 64364359
Febrile bone marrow aplasia 9.83 9.76 3 104546 11252 64382931
Nocardiosis 9.82 9.76 23 104526 4744 64389439
Fungal disease carrier 9.81 9.76 6 104543 281 64393902
Hypertension 9.80 9.76 514 104035 258747 64135436
Musculoskeletal chest pain 9.78 9.76 64 104485 21415 64372768

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
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
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
Arginosuccinate Lyase Deficiency contraindication
Uncontrolled Bacterial Infections contraindication
Nasal Septal Ulcers contraindication
Nasal Trauma contraindication
Untreated Fungal Infection contraindication
Nasal Candidiasis contraindication
Oropharyngeal Candidiasis contraindication
Ornithine Carbamyltransferase Deficiency contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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)
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, EXTENDED 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, EXTENDED 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, EXTENDED 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, EXTENDED 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
4MG TARPEYO CALLIDITAS N215935 Dec. 15, 2021 RX CAPSULE, DELAYED RELEASE ORAL Dec. 15, 2024 NEW PRODUCT

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
004214 NDDF
108622005 SNOMEDCT_US
395726003 SNOMEDCT_US
4020889 VANDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-6815 SUSPENSION 0.25 mg RESPIRATORY (INHALATION) ANDA 26 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-6815 SUSPENSION 0.25 mg RESPIRATORY (INHALATION) ANDA 26 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-6816 SUSPENSION 0.50 mg RESPIRATORY (INHALATION) ANDA 26 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-6816 SUSPENSION 0.50 mg RESPIRATORY (INHALATION) ANDA 26 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0093-6817 SUSPENSION 1 mg RESPIRATORY (INHALATION) ANDA 26 sections
Budesonide Inhalation HUMAN PRESCRIPTION DRUG LABEL 1 0115-1687 SUSPENSION 0.25 mg RESPIRATORY (INHALATION) ANDA 25 sections
Budesonide Inhalation HUMAN PRESCRIPTION DRUG LABEL 1 0115-1689 SUSPENSION 0.50 mg RESPIRATORY (INHALATION) ANDA 25 sections
SYMBICORT HUMAN PRESCRIPTION DRUG LABEL 2 0186-0370 AEROSOL 160 ug RESPIRATORY (INHALATION) NDA 28 sections
SYMBICORT HUMAN PRESCRIPTION DRUG LABEL 2 0186-0372 AEROSOL 80 ug RESPIRATORY (INHALATION) NDA 28 sections
PULMICORTFLEXHALER HUMAN PRESCRIPTION DRUG LABEL 1 0186-0916 AEROSOL, POWDER 180 ug RESPIRATORY (INHALATION) NDA 25 sections
PULMICORTFLEXHALER HUMAN PRESCRIPTION DRUG LABEL 1 0186-0917 AEROSOL, POWDER 90 ug RESPIRATORY (INHALATION) NDA 25 sections
PULMICORT RESPULES HUMAN PRESCRIPTION DRUG LABEL 1 0186-1988 SUSPENSION 0.25 mg RESPIRATORY (INHALATION) NDA 25 sections
PULMICORT RESPULES HUMAN PRESCRIPTION DRUG LABEL 1 0186-1989 SUSPENSION 0.50 mg RESPIRATORY (INHALATION) NDA 25 sections
PULMICORT RESPULES HUMAN PRESCRIPTION DRUG LABEL 1 0186-1990 SUSPENSION 1 mg RESPIRATORY (INHALATION) NDA 25 sections
BREZTRI HUMAN PRESCRIPTION DRUG LABEL 3 0310-4616 AEROSOL, METERED 160 ug RESPIRATORY (INHALATION) NDA 28 sections
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
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0378-4500 TABLET, FILM COATED, EXTENDED RELEASE 9 mg ORAL ANDA 28 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0378-7155 CAPSULE, DELAYED RELEASE 3 mg ORAL ANDA 29 sections
BREYNA HUMAN PRESCRIPTION DRUG LABEL 2 0378-7502 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) ANDA 29 sections
BREYNA HUMAN PRESCRIPTION DRUG LABEL 2 0378-7503 AEROSOL, METERED 160 ug RESPIRATORY (INHALATION) ANDA 29 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0487-9601 INHALANT 0.25 mg RESPIRATORY (INHALATION) ANDA 27 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0487-9701 INHALANT 0.50 mg RESPIRATORY (INHALATION) ANDA 27 sections
Budesonide HUMAN OTC DRUG LABEL 1 0536-1112 SPRAY, METERED 32 ug NASAL ANDA 15 sections
Entocort EC HUMAN PRESCRIPTION DRUG LABEL 1 0574-9850 CAPSULE 3 mg ORAL NDA 28 sections
budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0574-9855 CAPSULE 3 mg ORAL NDA 27 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0591-2510 TABLET, FILM COATED, EXTENDED RELEASE 9 mg ORAL ANDA 27 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0591-2510 TABLET, FILM COATED, EXTENDED RELEASE 9 mg ORAL ANDA 27 sections
Budesonide HUMAN PRESCRIPTION DRUG LABEL 1 0781-7515 SUSPENSION 0.25 mg RESPIRATORY (INHALATION) ANDA 26 sections