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

Stem definitionDrug idCAS RN
humanized origin 5061 196078-29-2

Description:

MoleculeDescription

Synonyms:

  • mepolizumab
  • nucala
  • SB 240563
  • SB-240563
Mepolizumab is an interleukin-5 antagonist (IgG1 kappa). IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Mepolizumab binds to IL-5 with a dissociation constant of 100 pM, inhibiting the bioactivity of IL-5 by blocking its binding to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
3.60 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
March 28, 2016 PMDA GlaxoSmithKline K.K.
Dec. 2, 2015 EMA GlaxoSmithKline Trading Services
Nov. 4, 2015 FDA GLAXOSMITHKLINE LLC

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
Wheezing 1924.46 25.39 1866 107475 236214 90282892
Full blood count abnormal 1209 25.39 674 108667 35923 90483183
Obstructive airways disorder 1127.06 25.39 573 108768 25296 90493810
Therapeutic product effect incomplete 1105.50 25.39 1263 108078 192633 90326473
Sleep disorder due to a general medical condition 968.61 25.39 628 108713 44110 90474996
Loss of personal independence in daily activities 710.56 25.39 848 108493 135257 90383849
Blepharospasm 628.65 25.39 527 108814 54918 90464188
Nasal polyps 627.30 25.39 292 109049 10588 90508518
Onychomadesis 601.13 25.39 475 108866 45523 90473583
Gastrooesophageal reflux disease 595.62 25.39 861 108480 165476 90353630
Dyspnoea 505.31 25.39 2248 107093 878707 89640399
Taste disorder 498.33 25.39 484 108857 61062 90458044
Nail disorder 458.62 25.39 454 108887 58613 90460493
Back injury 443.43 25.39 401 108940 46221 90472885
Breast cancer stage III 412.43 25.39 509 108832 83938 90435168
Sputum discoloured 411.32 25.39 274 109067 20117 90498989
Onychomycosis 408.64 25.39 348 108993 37028 90482078
Peripheral venous disease 406.91 25.39 504 108837 83417 90435689
Epilepsy 397.45 25.39 493 108848 81713 90437393
Productive cough 396.64 25.39 477 108864 76586 90442520
Upper-airway cough syndrome 388.99 25.39 237 109104 14898 90504208
Lung disorder 388.13 25.39 669 108672 149214 90369892
Product quality issue 382.34 25.39 475 108866 78850 90440256
Rhinitis allergic 371.39 25.39 239 109102 16546 90502560
Eosinophilia 371.31 25.39 294 109047 28239 90490867
Facet joint syndrome 345.59 25.39 505 108836 97884 90421222
Cough 327.80 25.39 1084 108257 367878 90151228
Acute kidney injury 326.72 25.39 14 109327 320373 90198733
Hypercholesterolaemia 323.16 25.39 496 108845 100396 90418710
Product complaint 320.54 25.39 201 109140 13299 90505807
Obesity 314.74 25.39 502 108839 105005 90414101
Bursitis 305.21 25.39 560 108781 131094 90388012
Asthma-chronic obstructive pulmonary disease overlap syndrome 302.76 25.39 138 109203 4761 90514345
Toxicity to various agents 298.82 25.39 11 109330 287835 90231271
Lip dry 289.73 25.39 472 108869 100483 90418623
Bronchial secretion retention 288.83 25.39 122 109219 3493 90515613
Drug interaction 285.48 25.39 11 109330 276442 90242664
Pulmonary function test abnormal 282.44 25.39 111 109230 2628 90516478
Total lung capacity increased 280.88 25.39 132 109209 4889 90514217
Bronchiectasis 275.44 25.39 223 109118 22107 90496999
Night sweats 267.83 25.39 523 108818 128243 90390863
Liver function test increased 267.27 25.39 414 108927 84441 90434665
Eosinophil count increased 264.34 25.39 176 109165 12905 90506201
Reversible airways obstruction 260.87 25.39 96 109245 1887 90517219
Wound infection 248.34 25.39 454 108887 105948 90413158
Neutropenia 242.79 25.39 6 109335 224898 90294208
Chest discomfort 233.80 25.39 516 108825 137849 90381257
Finger deformity 233.57 25.39 241 109100 32656 90486450
Wrong technique in device usage process 230.25 25.39 121 109220 5714 90513392
Joint range of motion decreased 228.23 25.39 505 108836 135138 90383968
C-reactive protein increased 222.64 25.39 598 108743 180791 90338315
Chest X-ray abnormal 222.46 25.39 113 109228 4969 90514137
Product dose omission issue 217.30 25.39 809 108532 290878 90228228
Hypotension 216.66 25.39 62 109279 325335 90193771
Neck pain 212.06 25.39 442 108899 113521 90405585
Adverse reaction 202.57 25.39 213 109128 29499 90489607
Thrombocytopenia 200.55 25.39 13 109328 208712 90310394
Pruritus 200.26 25.39 215 109126 541310 89977796
Ear pruritus 199.49 25.39 116 109225 6687 90512419
Breath sounds abnormal 199.00 25.39 158 109183 15228 90503878
Product label confusion 198.69 25.39 187 109154 22663 90496443
Sarcoidosis 197.53 25.39 136 109205 10537 90508569
Type 2 diabetes mellitus 197.26 25.39 616 108725 202628 90316478
Exposure via skin contact 194.81 25.39 135 109206 10570 90508536
Inflammation 191.84 25.39 561 108780 178031 90341075
Dehydration 184.21 25.39 13 109328 194434 90324672
Infusion site reaction 183.40 25.39 165 109176 18874 90500232
Urinary tract infection 182.84 25.39 70 109271 305562 90213544
Live birth 180.08 25.39 334 109007 78773 90440333
Lower respiratory tract infection 174.07 25.39 680 108661 249979 90269127
Folliculitis 173.66 25.39 592 108749 203761 90315345
Eosinophil count abnormal 172.02 25.39 57 109284 809 90518297
Osteoarthritis 170.71 25.39 572 108769 195158 90323948
Dry mouth 169.57 25.39 548 108793 183511 90335595
Gait inability 167.88 25.39 471 108870 145985 90373121
Vital capacity decreased 167.69 25.39 68 109273 1751 90517355
Nasal congestion 163.97 25.39 331 109010 83083 90436023
Diarrhoea 163.41 25.39 584 108757 938606 89580500
Disease progression 162.41 25.39 6 109335 156609 90362497
Sputum culture positive 156.89 25.39 69 109272 2184 90516922
Anaemia 155.41 25.39 119 109222 352683 90166423
White blood cell count decreased 153.14 25.39 13 109328 167096 90352010
Nausea 150.37 25.39 760 108581 1109556 89409550
Cardiac murmur 148.89 25.39 144 109197 18050 90501056
Fatigue 147.86 25.39 805 108536 1153218 89365888
Blood lactic acid increased 146.50 25.39 105 109236 8673 90510433
Pulmonary mass 146.15 25.39 177 109164 28595 90490511
Hyponatraemia 142.44 25.39 4 109337 133534 90385572
Haemoglobin decreased 142.04 25.39 15 109326 161941 90357165
Irritable bowel syndrome 141.72 25.39 560 108781 206888 90312218
Pyrexia 138.51 25.39 377 108964 660108 89858998
Platelet count decreased 136.23 25.39 7 109334 136962 90382144
Muscle injury 133.08 25.39 492 108849 176162 90342944
Psoriatic arthropathy 133.00 25.39 587 108754 227748 90291358
Bacterial disease carrier 132.70 25.39 58 109283 1808 90517298
Coeliac disease 129.84 25.39 210 109131 44400 90474706
Somnolence 128.17 25.39 46 109295 209038 90310068
Bronchopulmonary aspergillosis allergic 126.00 25.39 70 109271 3696 90515410
Blood cholesterol increased 125.90 25.39 541 108800 207471 90311635
Constipation 122.91 25.39 95 109246 280300 90238806
Urticaria 122.46 25.39 719 108622 312015 90207091
Sepsis 121.95 25.39 33 109308 179781 90339325
Memory impairment 120.91 25.39 515 108826 196729 90322377
Injection site reaction 119.40 25.39 310 109031 91770 90427336
Fibromyalgia 119.14 25.39 529 108812 205740 90313366
Hypokalaemia 115.34 25.39 12 109329 131104 90388002
Sleep disorder 114.47 25.39 508 108833 197522 90321584
Death 114.40 25.39 237 109104 456314 90062792
Total lung capacity decreased 112.04 25.39 65 109276 3730 90515376
Dyspnoea exertional 111.35 25.39 260 109081 72028 90447078
Multiple allergies 111.19 25.39 113 109228 15033 90504073
Rales 110.62 25.39 115 109226 15712 90503394
Hypomania 110.02 25.39 89 109252 8808 90510298
Musculoskeletal pain 109.52 25.39 453 108888 170798 90348308
Muscle spasms 107.71 25.39 593 108748 251290 90267816
Liver injury 107.36 25.39 449 108892 170118 90348988
Migraine 106.72 25.39 484 108857 189908 90329198
Jaundice cholestatic 106.65 25.39 92 109249 9951 90509155
Erythema 102.59 25.39 76 109265 229170 90289936
Bronchial obstruction 99.42 25.39 46 109295 1643 90517463
Superinfection 99.10 25.39 56 109285 3056 90516050
Grip strength decreased 98.54 25.39 290 109051 92286 90426820
Hypocholesterolaemia 96.00 25.39 72 109269 6377 90512729
Blood test abnormal 95.36 25.39 122 109219 20830 90498276
Overlap syndrome 94.23 25.39 80 109261 8468 90510638
Cardiac failure 93.83 25.39 11 109330 109485 90409621
Chronic obstructive pulmonary disease 93.09 25.39 246 109095 73583 90445523
Seizure 92.81 25.39 34 109307 152595 90366511
Paraesthesia 92.48 25.39 567 108774 249759 90269347
Bronchial wall thickening 92.16 25.39 47 109294 2084 90517022
Sneezing 91.57 25.39 144 109197 29725 90489381
Factor V Leiden mutation 88.83 25.39 27 109314 284 90518822
Lung opacity 88.34 25.39 67 109274 6035 90513071
Anti-cyclic citrullinated peptide antibody positive 88.26 25.39 537 108804 235896 90283210
Asthmatic crisis 88.09 25.39 44 109297 1866 90517240
Bradycardia 87.65 25.39 3 109338 83844 90435262
Rhinitis 86.68 25.39 94 109247 13478 90505628
Neuropathy peripheral 85.87 25.39 29 109312 136941 90382165
Respiratory failure 85.61 25.39 19 109322 118399 90400707
Respiratory symptom 85.40 25.39 57 109284 4195 90514911
Lung neoplasm malignant 84.28 25.39 124 109217 24149 90494957
Deep vein thrombosis 84.27 25.39 7 109334 91613 90427493
Ill-defined disorder 84.23 25.39 443 108898 184448 90334658
Leukopenia 84.14 25.39 11 109330 100699 90418407
Asthma 83.53 25.39 539 108802 241621 90277485
Accidental exposure to product 83.08 25.39 168 109173 42198 90476908
Rheumatic fever 82.63 25.39 385 108956 152736 90366370
Impaired healing 81.84 25.39 523 108818 233676 90285430
Helicobacter infection 81.38 25.39 510 108831 226340 90292766
Drug-induced liver injury 80.47 25.39 266 109075 90052 90429054
Hepatic enzyme 80.30 25.39 60 109281 5284 90513822
Renal failure 79.96 25.39 29 109312 130978 90388128
Cardiac arrest 79.66 25.39 15 109326 104920 90414186
Hepatitis 78.55 25.39 225 109116 70514 90448592
Underdose 78.55 25.39 190 109151 53827 90465279
Balance disorder 77.84 25.39 12 109329 97068 90422038
Pericarditis 77.64 25.39 575 108766 269576 90249530
Duodenal ulcer perforation 76.59 25.39 493 108848 220795 90298311
Prolonged expiration 76.38 25.39 35 109306 1222 90517884
Schizophrenia 76.14 25.39 92 109249 14822 90504284
Septic shock 75.86 25.39 7 109334 84153 90434953
Respiratory tract infection 75.65 25.39 198 109143 58880 90460226
Gastrointestinal haemorrhage 75.05 25.39 10 109331 90238 90428868
Depression 74.90 25.39 619 108722 299982 90219124
Suicide attempt 74.51 25.39 4 109337 75395 90443711
Middle insomnia 73.82 25.39 96 109245 16655 90502451
Blood glucose increased 73.63 25.39 13 109328 95233 90423873
Syncope 73.46 25.39 34 109307 132629 90386477
Asthma exercise induced 72.41 25.39 26 109315 475 90518631
Coma 71.31 25.39 4 109337 72628 90446478
Hypoglycaemia 71.29 25.39 3 109338 69845 90449261
Wound 69.74 25.39 613 108728 302367 90216739
Hyperhidrosis 69.40 25.39 39 109302 136266 90382840
Injury 69.10 25.39 441 108900 196908 90322198
Eosinophilic granulomatosis with polyangiitis 68.56 25.39 41 109300 2489 90516617
Agitation 68.09 25.39 3 109338 67095 90452011
Platelet count increased 67.35 25.39 103 109238 20756 90498350
Interstitial lung disease 67.17 25.39 7 109334 76398 90442708
General physical health deterioration 66.14 25.39 687 108654 354428 90164678
Nasopharyngitis 65.04 25.39 764 108577 406340 90112766
Vasculitis 64.90 25.39 106 109235 22587 90496519
Hypoaesthesia 64.86 25.39 621 108720 313589 90205517
Cognitive disorder 64.68 25.39 5 109336 69402 90449704
Heart sounds 63.75 25.39 30 109311 1114 90517992
Abdominal pain 62.73 25.39 255 109086 395466 90123640
Bronchospasm 62.32 25.39 99 109242 20610 90498496
Myocardial infarction 62.10 25.39 25 109316 105947 90413159
Feeling abnormal 62.10 25.39 66 109275 167169 90351937
Blister 61.85 25.39 522 108819 254476 90264630
Epistaxis 60.84 25.39 14 109327 85111 90433995
Loss of consciousness 60.79 25.39 48 109293 140190 90378916
Intentional product use issue 60.79 25.39 459 108882 216433 90302673
Weight decreased 60.73 25.39 244 109097 379666 90139440
Renal impairment 59.96 25.39 26 109315 105395 90413711
Synovitis 59.54 25.39 634 108707 329118 90189988
Wrong technique in product usage process 59.35 25.39 8 109333 71563 90447543
C-reactive protein abnormal 58.47 25.39 306 109035 127123 90391983
Vomiting 58.40 25.39 639 108702 787654 89731452
Drug abuse 57.95 25.39 14 109327 82333 90436773
Intentional product misuse 57.87 25.39 18 109323 89586 90429520
Dysphagia 57.34 25.39 32 109309 112246 90406860
Broncholithiasis 56.19 25.39 19 109322 288 90518818
Lymph node calcification 55.47 25.39 20 109321 370 90518736
Pulmonary embolism 55.18 25.39 46 109295 130774 90388332
Pemphigus 55.12 25.39 620 108721 326244 90192862
Infection 54.49 25.39 238 109103 361856 90157250
Blood immunoglobulin E increased 54.15 25.39 44 109297 4381 90514725
Vocal cord dysfunction 54.13 25.39 25 109316 889 90518217
Psoriasis 54.09 25.39 59 109282 147695 90371411
Cystitis 54.05 25.39 8 109333 66710 90452396
Lacrimation increased 53.88 25.39 108 109233 26954 90492152
Kyphosis 53.68 25.39 37 109304 2871 90516235
Normal newborn 53.58 25.39 99 109242 23263 90495843
Pneumonia 53.55 25.39 1073 108268 636986 89882120
Increased bronchial secretion 53.49 25.39 33 109308 2120 90516986
Sleep disorder due to general medical condition, insomnia type 53.36 25.39 46 109295 128648 90390458
Cardio-respiratory arrest 52.49 25.39 7 109334 63133 90455973
Eye pruritus 52.10 25.39 111 109230 28916 90490190
Glossodynia 50.52 25.39 602 108739 321177 90197929
Thrombosis 50.49 25.39 13 109328 73238 90445868
Sinus operation 50.42 25.39 36 109305 2955 90516151
Suicidal ideation 49.22 25.39 14 109327 73841 90445265
Skin ulcer 48.42 25.39 3 109338 50072 90469034
Hospitalisation 48.42 25.39 292 109049 127808 90391298
Drug ineffective 48.17 25.39 1288 108053 1383010 89136096
CFTR gene mutation 47.91 25.39 16 109325 233 90518873
Laryngeal stenosis 47.86 25.39 26 109315 1313 90517793
Sputum purulent 47.62 25.39 26 109315 1326 90517780
Oedema 47.57 25.39 107 109234 200188 90318918
Back pain 47.39 25.39 209 109132 316966 90202140
Scoliosis 47.20 25.39 56 109285 8851 90510255
Hallucination 46.83 25.39 11 109330 65948 90453158
Dry skin 46.58 25.39 24 109317 88049 90431057
Abdominal pain upper 46.07 25.39 608 108733 332066 90187040
Abdominal distension 45.79 25.39 292 109049 130309 90388797
Angioedema 45.71 25.39 11 109330 64865 90454241
Dyspepsia 45.07 25.39 400 108941 197760 90321346
Skin exfoliation 45.02 25.39 13 109328 67900 90451206
Rhinorrhoea 44.67 25.39 218 109123 88098 90431008
Nematodiasis 44.16 25.39 10 109331 27 90519079
Chronic sinusitis 43.85 25.39 92 109249 23710 90495396
Femur fracture 43.85 25.39 3 109338 46079 90473027
Sinus disorder 43.63 25.39 115 109226 34332 90484774
Cerebrovascular accident 43.39 25.39 51 109290 123482 90395624
Aspiration 43.12 25.39 72 109269 15621 90503485
Headache 42.86 25.39 758 108583 861988 89657118
Chills 42.70 25.39 58 109283 131923 90387183
International normalised ratio increased 42.47 25.39 4 109337 47312 90471794
Gait disturbance 42.43 25.39 166 109175 260330 90258776
Sputum retention 41.91 25.39 19 109322 647 90518459
Maternal exposure during pregnancy 41.82 25.39 638 108703 359425 90159681
Cellulitis 41.19 25.39 30 109311 91307 90427799
Mobility decreased 41.07 25.39 473 108868 250261 90268845
Nonspecific reaction 41.01 25.39 31 109310 2778 90516328
Anxiety 39.97 25.39 215 109126 309557 90209549
Sputum culture 39.66 25.39 15 109326 319 90518787
Dysgeusia 38.87 25.39 8 109333 52552 90466554
Dysarthria 38.85 25.39 9 109332 54473 90464633
Neurosensory hypoacusis 37.46 25.39 13 109328 214 90518892
Venous pressure jugular increased 37.38 25.39 17 109324 583 90518523
Hyperglycaemia 37.19 25.39 8 109333 50962 90468144
Respiratory tract inflammation 36.85 25.39 17 109324 603 90518503
Systemic lupus erythematosus 36.33 25.39 626 108715 361270 90157836
Peak expiratory flow rate decreased 36.28 25.39 17 109324 625 90518481
Rheumatoid factor positive 35.82 25.39 98 109243 171552 90347554
Muscular weakness 35.71 25.39 394 108947 206272 90312834
COVID-19 35.54 25.39 96 109245 168747 90350359
Unevaluable event 35.45 25.39 11 109330 54837 90464269
Visual impairment 35.42 25.39 66 109275 132299 90386807
Swelling face 35.05 25.39 28 109313 81324 90437782
Sinusitis 35.03 25.39 256 109085 342832 90176274
Incorrect product administration duration 34.80 25.39 74 109267 19248 90499858
Gamma-glutamyltransferase increased 34.62 25.39 3 109338 37949 90481157
Staphylococcal infection 34.54 25.39 8 109333 48431 90470675
Pleural effusion 34.46 25.39 51 109290 111940 90407166
Mouth ulceration 34.28 25.39 4 109337 39970 90479136
Product use in unapproved indication 34.24 25.39 583 108758 335653 90183453
Eye pain 34.19 25.39 6 109335 44162 90474944
Disorientation 34.14 25.39 6 109335 44108 90474998
Hepatic enzyme increased 34.07 25.39 618 108723 360118 90158988
Respiratory gas exchange disorder 33.33 25.39 14 109327 395 90518711
Influenza like illness 33.19 25.39 29 109312 80582 90438524
Tinnitus 33.05 25.39 6 109335 43096 90476010
Foetal exposure during pregnancy 32.92 25.39 6 109335 42969 90476137
Pulmonary function test decreased 32.03 25.39 33 109308 4461 90514645
Hypomagnesaemia 31.96 25.39 3 109338 35585 90483521
Ascites 31.90 25.39 9 109332 47731 90471375
Lymphocyte count decreased 31.36 25.39 3 109338 35047 90484059
Mycobacterium avium complex infection 30.86 25.39 31 109310 4067 90515039
Pericardial effusion 30.81 25.39 4 109337 36829 90482277
Blood pressure systolic increased 30.70 25.39 16 109325 58329 90460777
Aphasia 30.67 25.39 7 109334 42805 90476301
Hand deformity 30.58 25.39 515 108826 295847 90223259
Flushing 30.58 25.39 37 109304 88454 90430652
Psychotic disorder 30.55 25.39 95 109246 31135 90487971
Congenital anomaly 30.53 25.39 38 109303 6309 90512797
Pulmonary hypertension 30.37 25.39 7 109334 42516 90476590
Dry eye 30.32 25.39 16 109325 57915 90461191
Fluid retention 30.26 25.39 37 109304 88054 90431052
Clostridium difficile infection 30.17 25.39 4 109337 36241 90482865
Tremor 30.09 25.39 90 109251 153083 90366023
Haemorrhage 29.73 25.39 24 109317 69345 90449761
Blood pressure fluctuation 29.68 25.39 13 109328 52400 90466706
Arthritis 29.60 25.39 103 109238 167212 90351894
Disturbance in attention 29.47 25.39 10 109331 47099 90472007
Flatulence 29.17 25.39 7 109334 41360 90477746
Pollakiuria 29.07 25.39 3 109338 33002 90486104
Cholelithiasis 29.02 25.39 133 109208 52373 90466733
Intestinal obstruction 28.84 25.39 5 109336 37126 90481980
Red blood cell count decreased 28.72 25.39 10 109331 46341 90472765
Premature delivery 28.45 25.39 6 109335 38756 90480350
Bone pain 28.42 25.39 20 109321 61963 90457143
Sinonasal obstruction 28.32 25.39 11 109330 252 90518854
Herpes zoster 28.25 25.39 44 109297 94600 90424506
Respiration abnormal 28.11 25.39 41 109300 7922 90511184
Tympanosclerosis 27.84 25.39 8 109333 68 90519038
Presyncope 27.73 25.39 3 109338 31802 90487304
Blood insulin abnormal 27.72 25.39 7 109334 34 90519072
Foot deformity 27.68 25.39 19 109322 59632 90459474
Secretion discharge 27.62 25.39 60 109281 15836 90503270
Tachycardia 27.27 25.39 98 109243 157575 90361531
Body temperature increased 27.10 25.39 10 109331 44700 90474406
Vaccination site haemorrhage 27.07 25.39 7 109334 38 90519068
Forced expiratory volume decreased 26.71 25.39 34 109307 5774 90513332
Cardiac disorder 26.54 25.39 18 109323 56854 90462252
Ulcer 26.50 25.39 4 109337 32878 90486228
Lymphadenopathy 26.49 25.39 11 109330 45764 90473342
Injection site erythema 26.45 25.39 49 109292 98453 90420653
Mite allergy 26.44 25.39 15 109326 825 90518281
Hypervolaemia 26.36 25.39 4 109337 32753 90486353
Decreased appetite 26.30 25.39 309 109032 376231 90142875
Blood calcium increased 26.28 25.39 50 109291 12008 90507098
Therapy cessation 26.28 25.39 100 109241 36261 90482845
Heart rate decreased 26.25 25.39 16 109325 53489 90465617
Blood pressure decreased 26.21 25.39 31 109310 74864 90444242
Dyskinesia 26.12 25.39 6 109335 36528 90482578
Chest pain 26.08 25.39 253 109088 319392 90199714
Oligoarthritis 25.94 25.39 13 109328 555 90518551
Knee arthroplasty 25.47 25.39 38 109303 83144 90435962

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
Wheezing 1798.91 33.96 821 26995 53960 42539559
Therapeutic product effect incomplete 1565.08 33.96 810 27006 70129 42523390
Full blood count abnormal 1231.31 33.96 526 27290 29350 42564169
Sleep disorder due to a general medical condition 1138.61 33.96 428 27388 17025 42576494
Obstructive airways disorder 1029.99 33.96 439 27377 24320 42569199
Loss of personal independence in daily activities 1003.26 33.96 536 27280 49280 42544239
Productive cough 743.27 33.96 446 27370 51121 42542398
Dyspnoea 627.15 33.96 1067 26749 441554 42151965
Asthma 564.32 33.96 403 27413 61911 42531608
Eosinophilic granulomatosis with polyangiitis 495.19 33.96 193 27623 8445 42585074
Respiratory symptom 383.59 33.96 173 27643 10933 42582586
Eosinophil count increased 376.01 33.96 169 27647 10594 42582925
Product dose omission issue 364.88 33.96 475 27341 153890 42439629
Cough 364.73 33.96 511 27305 177592 42415927
Forced expiratory volume decreased 312.47 33.96 134 27682 7496 42586023
Vasculitis 279.84 33.96 165 27651 18229 42575290
Nasal polyps 274.74 33.96 101 27715 3750 42589769
Lung disorder 272.98 33.96 236 27580 47687 42545832
Sputum discoloured 264.10 33.96 130 27686 10002 42583517
Pulmonary vasculitis 259.72 33.96 111 27705 6155 42587364
Neuritis 253.90 33.96 109 27707 6111 42587408
Chest discomfort 239.34 33.96 249 27567 63367 42530152
Haemoptysis 222.62 33.96 207 27609 45960 42547559
Total lung capacity abnormal 222.21 33.96 90 27726 4353 42589166
Neurological symptom 210.36 33.96 111 27705 9880 42583639
Product complaint 209.17 33.96 94 27722 5883 42587636
Acute kidney injury 208.98 33.96 7 27809 367330 42226189
Conjunctivitis allergic 203.80 33.96 92 27724 5819 42587700
Diarrhoea 202.94 33.96 30 27786 460819 42132700
Spirometry abnormal 196.37 33.96 86 27730 5060 42588459
Chronic sinusitis 195.05 33.96 76 27740 3316 42590203
Mite allergy 194.73 33.96 85 27731 4961 42588558
Mycotic allergy 194.00 33.96 84 27732 4807 42588712
Breath sounds abnormal 193.18 33.96 112 27704 11981 42581538
Dust allergy 187.04 33.96 84 27732 5248 42588271
Bronchopulmonary aspergillosis allergic 185.76 33.96 80 27736 4518 42589001
Antineutrophil cytoplasmic antibody positive 173.24 33.96 75 27741 4290 42589229
Lower respiratory tract infection 168.89 33.96 169 27647 41037 42552482
Pulmonary alveolar haemorrhage 164.89 33.96 109 27707 14707 42578812
Nodule 156.18 33.96 99 27717 12435 42581084
Blood immunoglobulin E increased 156.12 33.96 66 27750 3559 42589960
Chronic obstructive pulmonary disease 156.09 33.96 199 27617 62915 42530604
Exposure via skin contact 153.59 33.96 72 27744 4966 42588553
Normochromic normocytic anaemia 147.85 33.96 85 27731 8946 42584573
Nausea 143.26 33.96 41 27775 396758 42196761
Respiratory disorder 140.51 33.96 116 27700 21969 42571550
Nasal congestion 135.85 33.96 129 27687 29372 42564147
Bronchial obstruction 133.19 33.96 48 27768 1681 42591838
Pulmonary fibrosis 133.12 33.96 122 27694 26559 42566960
Bronchiectasis 125.95 33.96 100 27716 17919 42575600
Blood test abnormal 122.34 33.96 86 27730 12820 42580699
Vital capacity decreased 118.59 33.96 33 27783 484 42593035
Wrong technique in device usage process 118.07 33.96 50 27766 2707 42590812
Dyspnoea exertional 117.50 33.96 154 27662 49994 42543525
Obesity 110.04 33.96 89 27727 16370 42577149
Neutropenia 109.14 33.96 5 27811 199426 42394093
Arteriosclerosis coronary artery 108.29 33.96 93 27723 18584 42574935
Asthma-chronic obstructive pulmonary disease overlap syndrome 107.91 33.96 40 27776 1519 42592000
Thrombocytopenia 106.70 33.96 4 27812 190275 42403244
Accidental exposure to product 105.15 33.96 95 27721 20298 42573221
Hospitalisation 99.62 33.96 176 27640 74154 42519365
Hypothyroidism 96.90 33.96 112 27704 31972 42561547
Mycobacterial infection 96.66 33.96 43 27773 2625 42590894
Rhinorrhoea 96.04 33.96 111 27705 31683 42561836
Arteriosclerosis 95.11 33.96 85 27731 17904 42575615
Obstruction 93.51 33.96 44 27772 3059 42590460
Hypoxia 93.20 33.96 165 27651 69621 42523898
Pulmonary function test abnormal 93.07 33.96 42 27774 2652 42590867
Hypotension 92.12 33.96 27 27789 257604 42335915
Upper respiratory tract infection 91.85 33.96 125 27691 42048 42551471
Multiple allergies 88.76 33.96 45 27771 3683 42589836
Capillaritis 87.48 33.96 38 27778 2190 42591329
Reversible airways obstruction 83.36 33.96 26 27790 577 42592942
Bronchial hyperreactivity 82.66 33.96 35 27781 1894 42591625
Eosinophil count abnormal 77.63 33.96 22 27794 346 42593173
Sleep disorder 76.53 33.96 123 27693 47972 42545547
Anxiety 76.36 33.96 209 27607 118351 42475168
Bronchiolitis 75.47 33.96 41 27775 3865 42589654
Sinusitis 75.32 33.96 121 27695 47171 42546348
Vomiting 74.27 33.96 49 27767 289674 42303845
Parathyroid gland enlargement 72.21 33.96 18 27798 167 42593352
Upper respiratory fungal infection 71.36 33.96 18 27798 176 42593343
Airway remodelling 69.37 33.96 25 27791 875 42592644
Anaemia 68.39 33.96 50 27766 280228 42313291
Eosinophilia 67.85 33.96 95 27721 32804 42560715
Foetal malformation 66.52 33.96 17 27799 176 42593343
Upper-airway cough syndrome 65.92 33.96 39 27777 4327 42589192
Eye disorder 63.62 33.96 56 27760 11556 42581963
Secretion discharge 63.49 33.96 47 27769 7588 42585931
Sinus congestion 62.65 33.96 45 27771 6935 42586584
Pulmonary function test decreased 60.93 33.96 41 27775 5691 42587828
Seizure 60 33.96 5 27811 120556 42472963
Coagulation factor V level abnormal 59.71 33.96 15 27801 144 42593375
White blood cell count decreased 59.60 33.96 3 27813 110393 42483126
Gastrooesophageal reflux disease 59.49 33.96 106 27710 44917 42548602
Eosinophilic bronchitis 57.16 33.96 16 27800 240 42593279
Decreased appetite 56.10 33.96 28 27788 193109 42400410
Lung diffusion test decreased 55.19 33.96 21 27795 858 42592661
Condition aggravated 53.30 33.96 321 27495 260433 42333086
Asthmatic crisis 53.13 33.96 18 27798 523 42592996
Nasal disorder 52.99 33.96 26 27790 1983 42591536
Forced expiratory volume 52.91 33.96 13 27803 113 42593406
Sepsis 51.99 33.96 33 27783 199301 42394218
Cardiac failure 51.64 33.96 5 27811 106851 42486668
Coagulation factor deficiency 51.46 33.96 15 27801 262 42593257
Dizziness 50.45 33.96 53 27763 249201 42344318
Dehydration 50.34 33.96 15 27801 141752 42451767
Lung hyperinflation 50.06 33.96 21 27795 1110 42592409
Restrictive pulmonary disease 49.48 33.96 22 27794 1341 42592178
Pulmonary mass 49.46 33.96 57 27759 16208 42577311
Lung diffusion disorder 48.74 33.96 13 27803 161 42593358
Influenza 48.65 33.96 118 27698 62057 42531462
Thrombosis 47.31 33.96 124 27692 68387 42525132
Adjustment disorder 46.60 33.96 21 27795 1321 42592198
Cardiac arrest 45.91 33.96 8 27808 109312 42484207
Illness 45.57 33.96 68 27748 24862 42568657
Disease progression 44.53 33.96 19 27797 143637 42449882
Inspiratory capacity abnormal 44.43 33.96 11 27805 99 42593420
Renal impairment 44.30 33.96 9 27807 110219 42483300
Snoring 43.63 33.96 29 27787 3944 42589575
Therapy cessation 43.57 33.96 60 27756 20390 42573129
Mycobacterium test positive 43.47 33.96 15 27801 461 42593058
Lymphadenopathy 43.36 33.96 78 27738 33287 42560232
Bronchial disorder 42.67 33.96 20 27796 1378 42592141
Polyp 41.99 33.96 30 27786 4584 42588935
Overdose 41.47 33.96 9 27807 105255 42488264
Trisomy 18 41.45 33.96 17 27799 848 42592671
Sputum purulent 41.09 33.96 16 27800 696 42592823
Oesophageal polyp 39.54 33.96 9 27807 54 42593465
Hypercholesterolaemia 39.02 33.96 45 27771 12804 42580715
Aspartate aminotransferase increased 38.94 33.96 3 27813 77160 42516359
Anosmia 38.91 33.96 30 27786 5146 42588373
Use of accessory respiratory muscles 38.26 33.96 14 27802 512 42593007
Nephrectomy 37.35 33.96 16 27800 891 42592628
Fall 37.02 33.96 60 27756 234460 42359059
Pleural effusion 36.90 33.96 9 27807 97157 42496362
Congenital hiatus hernia 36.29 33.96 31 27785 6143 42587376
Atopy 36.24 33.96 16 27800 959 42592560
Factor V Leiden mutation 36.02 33.96 11 27805 227 42593292
Death 35.91 33.96 172 27644 471013 42122506
Renal failure 35.83 33.96 25 27791 143701 42449818
Septic shock 35.78 33.96 8 27808 91664 42501855
Intentional product use issue 35.67 33.96 3 27813 71830 42521689
Asthenia 35.50 33.96 82 27734 280711 42312808
Rhinitis allergic 35.01 33.96 25 27791 3817 42589702
Urinary tract infection 34.34 33.96 11 27805 99273 42494246

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
Wheezing 2970.46 27.71 2396 123312 252834 110210757
Full blood count abnormal 1898.24 27.71 1028 124680 55024 110408567
Obstructive airways disorder 1679.36 27.71 888 124820 45261 110418330
Therapeutic product effect incomplete 1652.10 27.71 1626 124082 222179 110241412
Sleep disorder due to a general medical condition 1521.44 27.71 867 124841 51245 110412346
Loss of personal independence in daily activities 1236.55 27.71 1159 124549 148861 110314730
Productive cough 908.79 27.71 866 124842 113439 110350152
Nasal polyps 767.80 27.71 350 125358 12850 110450741
Dyspnoea 712.51 27.71 2806 122902 1104066 109359525
Gastrooesophageal reflux disease 689.47 27.71 933 124775 179043 110284548
Blepharospasm 650.39 27.71 522 125186 54329 110409262
Acute kidney injury 636.15 27.71 19 125689 635411 109828180
Onychomadesis 631.43 27.71 476 125232 45187 110418404
Sputum discoloured 612.79 27.71 387 125321 27558 110436033
Lung disorder 585.30 27.71 863 124845 179184 110284407
Cough 552.97 27.71 1451 124257 460190 110003401
Drug interaction 519.40 27.71 10 125698 500173 109963418
Toxicity to various agents 514.35 27.71 6 125702 480549 109983042
Eosinophil count increased 495.44 27.71 305 125403 20753 110442838
Nail disorder 483.17 27.71 451 125257 57484 110406107
Taste disorder 482.88 27.71 476 125232 64911 110398680
Back injury 472.39 27.71 408 125300 46991 110416600
Hypercholesterolaemia 455.72 27.71 539 125169 90298 110373293
Upper-airway cough syndrome 454.85 27.71 261 125447 15596 110447995
Onychomycosis 440.43 27.71 359 125349 38172 110425419
Breast cancer stage III 434.69 27.71 492 125216 78625 110384966
Obesity 423.72 27.71 581 125127 112770 110350821
Rhinitis allergic 417.61 27.71 258 125450 17664 110445927
Eosinophilic granulomatosis with polyangiitis 412.25 27.71 214 125494 10472 110453119
Peripheral venous disease 406.93 27.71 490 125218 83627 110379964
Chest discomfort 395.43 27.71 709 124999 173139 110290452
Asthma-chronic obstructive pulmonary disease overlap syndrome 393.62 27.71 176 125532 6168 110457423
Neutropenia 382.82 27.71 9 125699 374611 110088980
Product quality issue 381.64 27.71 455 125253 76844 110386747
Respiratory symptom 365.73 27.71 222 125486 14723 110448868
Bronchiectasis 357.29 27.71 311 125397 36182 110427409
Facet joint syndrome 352.37 27.71 490 125218 96338 110367253
Epilepsy 345.25 27.71 494 125214 99715 110363876
Breath sounds abnormal 344.88 27.71 262 125446 25142 110438449
Hypotension 344.09 27.71 86 125622 523763 109939828
Lower respiratory tract infection 343.96 27.71 815 124893 242291 110221300
Pulmonary function test abnormal 340.19 27.71 148 125560 4852 110458739
Thrombocytopenia 336.35 27.71 14 125694 348871 110114720
Eosinophilia 324.53 27.71 364 125344 57572 110406019
Night sweats 316.92 27.71 556 125152 133427 110330164
Bursitis 316.25 27.71 546 125162 129372 110334219
Wound infection 296.90 27.71 451 125257 96014 110367577
Lip dry 292.71 27.71 457 125251 99626 110363965
Bronchial secretion retention 291.46 27.71 133 125575 4891 110458700
Total lung capacity increased 289.25 27.71 133 125575 4979 110458612
Reversible airways obstruction 287.80 27.71 108 125600 2391 110461200
Folliculitis 283.99 27.71 604 125104 167049 110296542
Vasculitis 275.71 27.71 267 125441 35606 110427985
Liver function test increased 273.93 27.71 415 125293 88133 110375458
Type 2 diabetes mellitus 269.03 27.71 611 125097 176621 110286970
Bronchopulmonary aspergillosis allergic 266.84 27.71 148 125560 8278 110455313
Joint range of motion decreased 259.34 27.71 483 125225 121349 110342242
Finger deformity 251.88 27.71 245 125463 32847 110430744
Diarrhoea 249.72 27.71 582 125126 1138923 109324668
Vital capacity decreased 247.54 27.71 92 125616 1981 110461610
Nasal congestion 241.69 27.71 415 125293 97867 110365724
Asthma 241.28 27.71 728 124980 249563 110214028
Forced expiratory volume decreased 238.80 27.71 162 125546 13014 110450577
Sleep disorder 233.68 27.71 621 125087 198023 110265568
Anaemia 232.21 27.71 170 125538 546916 109916675
Dehydration 232.07 27.71 24 125684 279487 110184104
Irritable bowel syndrome 227.20 27.71 546 125162 163669 110299922
Product dose omission issue 226.71 27.71 842 124866 320940 110142651
Muscle injury 217.62 27.71 489 125219 140318 110323273
Adverse reaction 217.58 27.71 215 125493 29379 110434212
Osteoarthritis 215.89 27.71 572 125136 182051 110281540
White blood cell count decreased 212.05 27.71 12 125696 229378 110234213
Neck pain 211.22 27.71 446 125262 122684 110340907
Death 210.17 27.71 293 125415 698576 109765015
Ear pruritus 209.54 27.71 120 125588 7140 110456451
Sepsis 208.56 27.71 57 125651 327289 110136302
Urinary tract infection 207.53 27.71 57 125651 326225 110137366
Product label confusion 207.46 27.71 186 125522 22491 110441100
Chest X-ray abnormal 202.35 27.71 124 125584 8363 110455228
Chronic obstructive pulmonary disease 200.87 27.71 407 125301 108751 110354840
Multiple allergies 199.28 27.71 141 125567 12122 110451469
Pulmonary vasculitis 198.95 27.71 112 125596 6448 110457143
Live birth 197.19 27.71 313 125395 69171 110394420
Disease progression 194.91 27.71 24 125684 244010 110219581
Pemphigus 193.62 27.71 610 125098 213960 110249631
Inflammation 192.73 27.71 569 125139 192669 110270922
Psoriatic arthropathy 192.09 27.71 575 125133 196186 110267405
Neuritis 191.62 27.71 114 125594 7285 110456306
Gait inability 189.22 27.71 454 125254 135922 110327669
Blood test abnormal 185.42 27.71 194 125514 28360 110435231
Sarcoidosis 184.70 27.71 136 125572 12443 110451148
Total lung capacity abnormal 183.16 27.71 94 125614 4489 110459102
Malignant neoplasm progression 183.01 27.71 3 125705 174564 110289027
Mite allergy 178.50 27.71 100 125608 5703 110457888
Dyspnoea exertional 177.39 27.71 376 125332 103684 110359907
Nausea 177.03 27.71 764 124944 1234926 109228665
Fibromyalgia 176.89 27.71 510 125198 170399 110293192
C-reactive protein increased 173.71 27.71 594 125114 217325 110246266
Glossodynia 173.36 27.71 601 125107 221403 110242188
Cardiac failure 172.84 27.71 10 125698 187616 110275975
Blood cholesterol increased 170.07 27.71 529 125179 184256 110279335
Product complaint 169.85 27.71 135 125573 13837 110449754
Anti-cyclic citrullinated peptide antibody positive 169.36 27.71 523 125185 181461 110282130
Pyrexia 168.77 27.71 495 125213 897770 109565821
Dust allergy 167.35 27.71 97 125611 5904 110457687
Dry mouth 167.31 27.71 554 125154 199394 110264197
Haemoglobin decreased 166.71 27.71 39 125669 248688 110214903
Infusion site reaction 165.66 27.71 147 125561 17535 110446056
Wound 163.78 27.71 612 125096 233825 110229766
Pruritus 162.86 27.71 256 125452 581304 109882287
Aspartate aminotransferase increased 162.66 27.71 4 125704 159932 110303659
Spirometry abnormal 161.71 27.71 92 125616 5405 110458186
Bronchial obstruction 161.45 27.71 76 125632 3003 110460588
Cardiac arrest 157.97 27.71 19 125689 196734 110266857
Seizure 157.84 27.71 30 125678 221155 110242436
Bradycardia 157.74 27.71 4 125704 155513 110308078
Helicobacter infection 157.61 27.71 510 125198 181367 110282224
Drug abuse 153.17 27.71 13 125695 177398 110286193
Liver injury 151.94 27.71 445 125263 149968 110313623
Memory impairment 150.14 27.71 529 125179 196415 110267176
Pulmonary mass 149.64 27.71 198 125510 37103 110426488
Haemoptysis 149.43 27.71 281 125427 71073 110392518
Gastrointestinal haemorrhage 148.93 27.71 10 125698 165508 110298083
Eosinophil count abnormal 148.08 27.71 53 125655 1021 110462570
Ill-defined disorder 148.00 27.71 453 125255 156400 110307191
Pericarditis 147.26 27.71 565 125143 218549 110245042
Impaired healing 147.06 27.71 525 125183 196192 110267399
Off label use 146.84 27.71 1052 124656 1499133 108964458
Coeliac disease 145.87 27.71 211 125497 42976 110420615
Blood immunoglobulin E increased 145.21 27.71 96 125612 7386 110456205
Migraine 143.94 27.71 476 125232 171176 110292415
Systemic lupus erythematosus 142.55 27.71 620 125088 253718 110209873
Conjunctivitis allergic 142.01 27.71 92 125616 6839 110456752
Hyperkalaemia 139.63 27.71 3 125705 135793 110327798
Injection site reaction 139.44 27.71 311 125397 88759 110374832
Rheumatic fever 138.81 27.71 378 125330 122201 110341390
Mycotic allergy 136.88 27.71 85 125623 5869 110457722
Duodenal ulcer perforation 136.04 27.71 478 125230 177222 110286369
Chronic sinusitis 136.00 27.71 155 125553 24929 110438662
Wrong technique in device usage process 135.04 27.71 89 125619 6812 110456779
Grip strength decreased 131.23 27.71 285 125423 79889 110383702
Septic shock 129.49 27.71 14 125694 157514 110306077
Hyponatraemia 129.33 27.71 43 125665 217610 110245981
Leukopenia 128.17 27.71 11 125697 148780 110314811
Cardiac murmur 128.17 27.71 149 125559 24479 110439112
Somnolence 127.92 27.71 91 125617 297358 110166233
Hypokalaemia 127.53 27.71 26 125682 182422 110281169
Renal failure 127.41 27.71 49 125659 226525 110237066
Exposure via skin contact 126.56 27.71 111 125597 13036 110450555
Urticaria 126.30 27.71 704 125004 318153 110145438
Synovitis 126.27 27.71 631 125077 273461 110190130
Nasopharyngitis 125.85 27.71 823 124885 393538 110070053
Antineutrophil cytoplasmic antibody positive 125.72 27.71 76 125632 5000 110458591
Constipation 125.34 27.71 133 125575 357653 110105938
Bacterial disease carrier 125.14 27.71 58 125650 2211 110461380
Maternal exposure during pregnancy 124.00 27.71 596 125112 254287 110209304
Renal impairment 121.50 27.71 32 125676 188413 110275178
Fatigue 120.56 27.71 849 124859 1215109 109248482
Coma 119.65 27.71 3 125705 117866 110345725
Hypoglycaemia 117.69 27.71 3 125705 116101 110347490
Sputum culture positive 116.86 27.71 66 125642 3823 110459768
Neurological symptom 115.85 27.71 114 125594 15494 110448097
Musculoskeletal pain 115.69 27.71 463 125245 182560 110281031
Rhinorrhoea 113.65 27.71 314 125394 102352 110361239
Depressed level of consciousness 109.84 27.71 4 125704 112274 110351317
Hand deformity 109.21 27.71 515 125193 217991 110245600
Hypomania 108.03 27.71 91 125617 10119 110453472
Agitation 107.33 27.71 5 125703 113046 110350545
Erythema 107.00 27.71 104 125604 291343 110172248
Sneezing 104.72 27.71 154 125554 31830 110431761
Paraesthesia 104.51 27.71 603 125105 275918 110187673
Cardio-respiratory arrest 104.19 27.71 7 125701 115829 110347762
Hypoaesthesia 104.02 27.71 662 125046 313561 110150030
Loss of consciousness 103.06 27.71 47 125661 196259 110267332
Muscle spasms 100.87 27.71 600 125108 277557 110186034
Asthmatic crisis 100.54 27.71 49 125659 2093 110461498
Hypocholesterolaemia 100.12 27.71 72 125636 6349 110457242
Hyperhidrosis 99.65 27.71 44 125664 187254 110276337
Lung opacity 99.58 27.71 92 125616 11560 110452031
Prolonged expiration 99.30 27.71 44 125664 1508 110462083
Overlap syndrome 98.45 27.71 82 125626 8977 110454614
Blood lactic acid increased 98.29 27.71 105 125603 15716 110447875
Rales 97.19 27.71 130 125578 24609 110438982
Suicide attempt 96.79 27.71 5 125703 103389 110360202
Middle insomnia 95.12 27.71 117 125591 20385 110443206
Injury 94.63 27.71 426 125282 176839 110286752
Multiple organ dysfunction syndrome 93.63 27.71 28 125680 151682 110311909
Lethargy 92.71 27.71 3 125705 93573 110370018
Mucosal inflammation 92.10 27.71 4 125704 96137 110367454
Blister 90.62 27.71 503 125205 226873 110236718
Blood glucose increased 90.30 27.71 20 125688 132476 110331115
Epistaxis 90.23 27.71 19 125689 130353 110333238
Neutrophil count decreased 89.30 27.71 15 125693 120926 110342665
Total lung capacity decreased 89.18 27.71 70 125638 7044 110456547
Dysphagia 88.38 27.71 32 125676 153568 110310023
Jaundice cholestatic 85.59 27.71 94 125614 14514 110449077
Pulmonary alveolar haemorrhage 85.54 27.71 110 125598 20040 110443551
Hepatic enzyme 85.36 27.71 60 125648 5103 110458488
Myocardial infarction 84.90 27.71 57 125651 192026 110271565
Hepatic function abnormal 84.61 27.71 4 125704 89291 110374300
International normalised ratio increased 81.85 27.71 4 125704 86768 110376823
Normochromic normocytic anaemia 79.95 27.71 86 125622 12971 110450620
Abdominal pain 78.83 27.71 308 125400 512681 109950910
Interstitial lung disease 78.53 27.71 30 125678 139304 110324287
Vomiting 77.78 27.71 662 125046 910013 109553578
Depression 76.79 27.71 620 125088 316715 110146876
Obstruction 75.15 27.71 58 125650 5694 110457897
Syncope 74.63 27.71 72 125636 202464 110261127
Neuropathy peripheral 74.25 27.71 57 125651 179220 110284371
Hepatic enzyme increased 72.86 27.71 618 125090 320274 110143317
Rheumatoid arthritis 72.83 27.71 586 125122 299027 110164564
Eye pruritus 72.27 27.71 132 125576 32643 110430948
C-reactive protein abnormal 71.70 27.71 315 125393 129380 110334211
Rash maculo-papular 71.39 27.71 3 125705 74219 110389372
Chills 71.10 27.71 67 125641 190513 110273078
Angioedema 71.01 27.71 13 125695 98487 110365104
Drug reaction with eosinophilia and systemic symptoms 70.88 27.71 6 125702 82089 110381502
Superinfection 70.72 27.71 56 125652 5707 110457884
Respiratory failure 69.97 27.71 85 125623 215247 110248344
Lacrimation increased 69.96 27.71 126 125582 30824 110432767
Mobility decreased 68.77 27.71 484 125224 236938 110226653
Lung neoplasm malignant 68.02 27.71 131 125577 33711 110429880
Mycobacterial infection 67.66 27.71 49 125659 4368 110459223
Respiratory tract infection 67.65 27.71 207 125501 71410 110392181
Back pain 67.60 27.71 207 125501 370789 110092802
Pulmonary fibrosis 67.56 27.71 262 125446 101780 110361811
Pleural effusion 66.85 27.71 62 125646 177647 110285944
Cerebrovascular accident 66.15 27.71 65 125643 181219 110282372
COVID-19 65.54 27.71 111 125597 244949 110218642
Heart sounds 65.49 27.71 30 125678 1113 110462478
Dysarthria 65.38 27.71 9 125699 84112 110379479
Deep vein thrombosis 65.26 27.71 39 125669 139848 110323743
General physical health deterioration 64.42 27.71 753 124955 424542 110039049
Capillaritis 64.26 27.71 38 125670 2401 110461190
Balance disorder 64.20 27.71 26 125682 116534 110347057
Normal newborn 63.99 27.71 100 125608 21796 110441795
Secretion discharge 62.73 27.71 95 125613 20149 110443442
Bronchial wall thickening 61.88 27.71 41 125667 3166 110460425
Hypocalcaemia 61.69 27.71 3 125705 65363 110398228
Ascites 61.27 27.71 15 125693 92793 110370798
Airway remodelling 61.22 27.71 27 125681 915 110462676
Hospitalisation 60.64 27.71 321 125387 142172 110321419
Suicidal ideation 60.44 27.71 16 125692 93921 110369670
Cognitive disorder 60.05 27.71 13 125695 87498 110376093
Hyperglycaemia 59.71 27.71 12 125696 85078 110378513
Abdominal pain upper 59.64 27.71 633 125075 348478 110115113
Parathyroid gland enlargement 59.23 27.71 18 125690 202 110463389
Underdose 58.46 27.71 182 125526 63372 110400219
Bronchiolitis 58.20 27.71 49 125659 5444 110458147
Bronchial hyperreactivity 58.16 27.71 41 125667 3503 110460088
Feeling abnormal 58.00 27.71 72 125636 180639 110282952
Dyspepsia 57.47 27.71 393 125315 190572 110273019
Gamma-glutamyltransferase increased 57.27 27.71 3 125705 61306 110402285
Sinus operation 57.13 27.71 38 125670 2953 110460638
Rhinitis 56.43 27.71 96 125612 22449 110441142
Pulmonary function test decreased 56.28 27.71 59 125649 8641 110454950
Hypomagnesaemia 56.25 27.71 3 125705 60367 110403224
Schizophrenia 56.04 27.71 94 125614 21732 110441859
Haematuria 55.61 27.71 13 125695 82992 110380599
Sinus disorder 55.44 27.71 118 125590 32610 110430981
Kyphosis 54.94 27.71 38 125670 3149 110460442
Vocal cord dysfunction 54.63 27.71 25 125683 925 110462666
Hepatitis 54.63 27.71 225 125483 89829 110373762
Broncholithiasis 54.21 27.71 18 125690 274 110463317
Increased bronchial secretion 54.19 27.71 41 125667 3907 110459684
Restrictive pulmonary disease 54.17 27.71 38 125670 3221 110460370
Lung diffusion disorder 54.09 27.71 18 125690 276 110463315
Haematocrit decreased 54.01 27.71 6 125702 66111 110397480
Disorientation 53.90 27.71 8 125700 70663 110392928
Bronchospasm 53.52 27.71 111 125597 30128 110433463
Decreased appetite 53.12 27.71 320 125388 475526 109988065
Lymphocyte count decreased 52.85 27.71 3 125705 57240 110406351
Arteriosclerosis coronary artery 52.67 27.71 99 125609 25019 110438572
Weight decreased 51.08 27.71 317 125391 467740 109995851
Dysgeusia 50.96 27.71 9 125699 69976 110393615
Staphylococcal infection 50.92 27.71 9 125699 69935 110393656
Scoliosis 50.82 27.71 56 125652 8677 110454914
Platelet count increased 50.57 27.71 100 125608 26234 110437357
Intentional product misuse 50.42 27.71 46 125662 132858 110330733
Oedema 50.04 27.71 102 125606 209874 110253717
Cardiogenic shock 50.03 27.71 4 125704 57334 110406257
Upper respiratory tract infection 49.95 27.71 287 125421 131041 110332550
Cytomegalovirus infection 49.82 27.71 3 125705 54441 110409150
Drug-induced liver injury 49.40 27.71 268 125440 119799 110343792
Aspiration 49.33 27.71 108 125600 30425 110433166
Shock 48.90 27.71 3 125705 53585 110410006
Nodule 48.89 27.71 112 125596 32519 110431072
CFTR gene mutation 48.84 27.71 16 125692 233 110463358
Laryngeal stenosis 48.26 27.71 26 125682 1372 110462219
Upper respiratory fungal infection 47.52 27.71 18 125690 409 110463182
Chronic kidney disease 47.21 27.71 14 125694 76277 110387314
Blood creatinine increased 46.93 27.71 85 125623 182804 110280787
Blood calcium increased 46.73 27.71 78 125630 17962 110445629
Accidental exposure to product 46.72 27.71 144 125564 49864 110413727
Haematemesis 46.71 27.71 6 125702 59102 110404489
Aphasia 46.59 27.71 6 125702 58991 110404600
Therapeutic product effect decreased 46.49 27.71 453 125255 243863 110219728
Coagulation factor V level abnormal 46.48 27.71 14 125694 152 110463439
Polyp 46.37 27.71 57 125651 9923 110453668
Infusion related reaction 46.29 27.71 648 125060 380514 110083077
Gastritis 46.15 27.71 4 125704 53695 110409896
Drug ineffective for unapproved indication 46.12 27.71 30 125678 102808 110360783
Tachycardia 46.02 27.71 120 125588 226525 110237066
Lymph node calcification 45.88 27.71 18 125690 451 110463140
Sputum abnormal 45.69 27.71 25 125683 1361 110462230
Intestinal obstruction 45.65 27.71 4 125704 53223 110410368
Contraindicated product administered 45.62 27.71 457 125251 247810 110215781
Acute respiratory distress syndrome 45.62 27.71 4 125704 53194 110410397
Eosinophilic bronchitis 45.33 27.71 19 125689 567 110463024
Intentional product use issue 44.91 27.71 455 125253 247451 110216140
Nematodiasis 44.76 27.71 10 125698 27 110463564
Drug intolerance 43.83 27.71 677 125031 405835 110057756
Flushing 43.74 27.71 33 125675 104703 110358888
Leukocytosis 43.68 27.71 5 125703 53823 110409768
Product prescribing error 43.64 27.71 4 125704 51327 110412264
Illness 43.46 27.71 197 125511 81974 110381617
Respiratory disorder 43.02 27.71 178 125530 71204 110392387
Forced expiratory volume 43.00 27.71 12 125696 97 110463494
Blood pressure fluctuation 42.34 27.71 16 125692 74808 110388783
Hallucination 42.31 27.71 32 125676 101400 110362191
Hypervolaemia 41.66 27.71 4 125704 49456 110414135
Tinnitus 41.52 27.71 9 125699 60531 110403060
Hypercalcaemia 41.43 27.71 3 125705 46654 110416937
Red blood cell count decreased 40.97 27.71 12 125696 65911 110397680
Disturbance in attention 40.96 27.71 10 125698 61985 110401606
Sputum purulent 40.88 27.71 26 125682 1872 110461719
Pulmonary hypertension 40.43 27.71 7 125701 55213 110408378
Blood pressure systolic increased 40.33 27.71 22 125686 82969 110380622
Swelling face 39.97 27.71 28 125680 92293 110371298
Swelling 39.92 27.71 590 125118 350451 110113140
Psoriasis 39.68 27.71 61 125647 139932 110323659
Haematoma 39.49 27.71 9 125699 58467 110405124
Arteriosclerosis 39.33 27.71 87 125621 24680 110438911
Haematochezia 39.24 27.71 44 125664 115480 110348111
Respiration abnormal 39.23 27.71 52 125656 9757 110453834
Dyskinesia 38.83 27.71 6 125702 51440 110412151
Therapy non-responder 38.69 27.71 75 125633 157232 110306359
Cellulitis 38.59 27.71 52 125656 125964 110337627
Atopy 38.55 27.71 21 125687 1133 110462458
Incorrect product administration duration 38.35 27.71 77 125631 20421 110443170
Inspiratory capacity abnormal 38.08 27.71 11 125697 102 110463489
Lip swelling 38.03 27.71 6 125702 50661 110412930
Nonspecific reaction 38.00 27.71 30 125678 3044 110460547
Swollen tongue 37.49 27.71 11 125697 60351 110403240
Mycobacterium test positive 37.28 27.71 17 125691 624 110462967
Exposure during pregnancy 37.19 27.71 321 125387 167103 110296488
Lung hyperinflation 37.07 27.71 26 125682 2203 110461388
Medication error 37.04 27.71 39 125669 105327 110358264
Cerebral infarction 37.02 27.71 7 125701 51831 110411760
Coagulation factor deficiency 36.97 27.71 14 125694 318 110463273
Peripheral swelling 36.95 27.71 655 125053 403379 110060212
Emphysema 36.71 27.71 74 125634 19682 110443909
Arthropathy 36.60 27.71 493 125215 287029 110176562
Body temperature increased 35.81 27.71 9 125699 54704 110408887
Hypophagia 35.74 27.71 8 125700 52618 110410973
Drug hypersensitivity 35.30 27.71 718 124990 453372 110010219
Hypertension 35.30 27.71 793 124915 509291 109954300
Fungal disease carrier 34.90 27.71 15 125693 477 110463114
Congenital anomaly 34.76 27.71 19 125689 1032 110462559
Respiratory gas exchange disorder 34.68 27.71 18 125690 880 110462711
Pleuritic pain 34.32 27.71 64 125644 16076 110447515
Femur fracture 33.99 27.71 5 125703 44464 110419127
Dysuria 33.88 27.71 13 125695 60218 110403373
Nasal disorder 33.44 27.71 32 125676 4202 110459389
Heart rate decreased 33.39 27.71 27 125681 82729 110380862
Mouth ulceration 33.33 27.71 7 125701 48131 110415460
Eye pain 33.26 27.71 8 125700 50091 110413500
Osteonecrosis of jaw 33.21 27.71 7 125701 48010 110415581
Neurosensory hypoacusis 32.88 27.71 12 125696 245 110463346
Atelectasis 32.71 27.71 104 125604 36608 110426983
Delirium 32.67 27.71 65 125643 134960 110328631
Drug withdrawal syndrome 32.26 27.71 3 125705 38051 110425540
Wrong technique in product usage process 32.22 27.71 31 125677 87317 110376274
Adverse drug reaction 32.19 27.71 218 125490 105341 110358250
Pneumonia aspiration 32.16 27.71 27 125681 81206 110382385
Respiratory tract inflammation 32.15 27.71 18 125690 1025 110462566
Herpes zoster 31.90 27.71 46 125662 108333 110355258
Blood pressure decreased 31.81 27.71 51 125657 115040 110348551
Abdominal pain lower 31.44 27.71 3 125705 37280 110426311
Lung diffusion test decreased 31.43 27.71 21 125687 1644 110461947
Unevaluable event 31.35 27.71 14 125694 59213 110404378
Electrolyte imbalance 31.17 27.71 3 125705 37025 110426566
Crepitations 30.99 27.71 49 125659 10786 110452805
Fluid retention 30.86 27.71 37 125671 94270 110369321
Ventricular fibrillation 30.77 27.71 5 125703 41308 110422283
Subdural haematoma 30.57 27.71 3 125705 36451 110427140
Sputum culture 30.54 27.71 12 125696 302 110463289
Pneumonia 30.51 27.71 1252 124456 875462 109588129
Oesophageal polyp 30.46 27.71 9 125699 91 110463500
Blood pressure diastolic decreased 29.97 27.71 3 125705 35882 110427709
Bronchial disorder 29.90 27.71 25 125683 2751 110460840
Stomatitis 29.85 27.71 452 125256 269790 110193801
Drug ineffective 29.70 27.71 1420 124288 1519120 108944471
Respiratory distress 29.67 27.71 21 125687 68853 110394738
Pollakiuria 29.45 27.71 7 125701 44188 110419403
Candida infection 29.36 27.71 9 125699 48000 110415591
Gastric ulcer 29.26 27.71 5 125703 39822 110423769
Oral pain 29.11 27.71 4 125704 37440 110426151
Sleep disorder due to general medical condition, insomnia type 29.02 27.71 47 125661 105596 110357995
Fall 28.96 27.71 497 125211 602985 109860606
Sputum retention 27.75 27.71 18 125690 1341 110462250

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R03DX09 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Other systemic drugs for obstructive airway diseases
FDA MoA N0000191871 Interleukin-5 Antagonists
FDA EPC N0000191872 Interleukin-5 Antagonist
CHEBI has role CHEBI:65023 anti-asthmatic agent

Related Drugs by ATC class:

R03DX Other systemic drugs for obstructive airway diseases 10 drugs
amlexanoxbenralizumabdepemokimab-ulaaeprozinolfenspirideomalizumabreslizumabroflumilastseratrodasttezepelumab

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

DiseaseRelationSNOMED_IDDOID
Allergic granulomatosis angiitis indication 82275008 DOID:3049
Asthma indication 195967001 DOID:2841
Eosinophilic asthma indication 367542003 DOID:9498




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Interleukin-5 Cytokine ANTIBODY BINDING Kd 10 DRUG LABEL DRUG LABEL

External reference:

IDSource
90Z2UF0E52 UNII
D04923 KEGG_DRUG
4035064 VANDF
C0969324 UMLSCUI
CHEBI:753401 CHEBI
CHEMBL2108429 ChEMBL_ID
DB06612 DRUGBANK_ID
7876 INN_ID
C434107 MESH_SUPPLEMENTAL_RECORD_UI
7685 IUPHAR_LIGAND_ID
1720597 RXNORM
237129 MMSL
27021 MMSL
d07571 MMSL
016563 NDDF
716046009 SNOMEDCT_US
781308003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Nucala HUMAN PRESCRIPTION DRUG LABEL 1 0173-0881 INJECTION, POWDER, FOR SOLUTION 100 mg SUBCUTANEOUS BLA 27 sections
Nucala HUMAN PRESCRIPTION DRUG LABEL 1 0173-0892 INJECTION, SOLUTION 100 mg SUBCUTANEOUS BLA 27 sections
Nucala HUMAN PRESCRIPTION DRUG LABEL 1 0173-0904 INJECTION, SOLUTION 40 mg SUBCUTANEOUS BLA 27 sections