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

Stem definitionDrug idCAS RN
beta3-adrenoreceptor agonists 4382 223673-61-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • YM178
  • myrbetriq
  • mirabegron
a beta-3 adrenergic agonist, relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 AR which increases bladder capacity
  • Molecular weight: 396.51
  • Formula: C21H24N4O2S
  • CLOGP: 1.32
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 4
  • TPSA: 100.27
  • ALOGS: -4.98
  • ROTB: 9
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
50 mg O

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 23.80 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 13.60 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.29 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 50 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.762 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 15.922 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.771 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 2.518 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 43.360 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 53.280 % High 1
herg hERG pIC50 4.552 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.300 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 11.722 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 47.760 % High 1
kinase-safety-class ACVR2B,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK1,GRK2,GRK3,ITK,JAK1,JAK2,MAP3K1,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MARK4,MELK,MET,MTOR,NTRK2,PAK4,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1 55
kinase-selectivity-class AURKA,AURKB,AXL,BRAF,EIF2AK3,FLT3,GRK2,MAP3K21,MAPK12,NTRK3,PDGFRB,PDK1,PDK4,PRKCD,PRKG1,SIK2,STK33,TTK 18
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 5.260 High 1
mh-clint Mouse hepatocyte intrinsic clearance 17.418 High 1
mppb Mouse plasma protein binding (% unbound) 40.230 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 7.362 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 57.820 % High 1
rh-clint Rat hepatocyte intrinsic clearance 10.789 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 77.740 % High 1
rppb Rat plasma protein binding (% unbound) 37.870 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 818.465 uM High 1

Approvals:

DateAgencyCompanyOrphan
June 28, 2012 FDA APGDI

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
Blepharospasm 854.49 14.40 577 86173 54868 90486829
Taste disorder 734.46 14.40 548 86202 60998 90480699
Epilepsy 613.10 14.40 557 86193 81649 90460048
Onychomadesis 594.83 14.40 430 86320 45568 90496129
Nail disorder 475.52 14.40 418 86332 58649 90483048
Back injury 455.73 14.40 369 86381 46253 90495444
Gastrooesophageal reflux disease 453.52 14.40 670 86080 165667 90376030
Breast cancer stage III 446.15 14.40 474 86276 83973 90457724
Peripheral venous disease 436.20 14.40 467 86283 83454 90458243
Product quality issue 416.82 14.40 444 86306 78881 90462816
Onychomycosis 395.59 14.40 310 86440 37066 90504631
Facet joint syndrome 393.50 14.40 478 86272 97911 90443786
Bursitis 362.61 14.40 533 86217 131121 90410576
Hypercholesterolaemia 338.28 14.40 449 86301 100443 90441254
Memory impairment 336.19 14.40 644 86106 196600 90345097
Obesity 309.22 14.40 440 86310 105067 90436630
C-reactive protein increased 297.77 14.40 583 86167 180806 90360891
Dry mouth 291.80 14.40 583 86167 183476 90358221
Wound infection 287.48 14.40 427 86323 105975 90435722
Lip dry 284.10 14.40 413 86337 100542 90441155
Night sweats 263.14 14.40 455 86295 128311 90413386
Toxicity to various agents 255.02 14.40 4 86746 287842 90253855
Inflammation 242.53 14.40 531 86219 178061 90363636
Neck pain 242.46 14.40 410 86340 113553 90428144
Infusion site reaction 239.22 14.40 175 86575 18864 90522833
Joint range of motion decreased 233.56 14.40 445 86305 135198 90406499
Lung disorder 229.42 14.40 468 86282 149415 90392282
Paraesthesia 229.30 14.40 640 86110 249686 90292011
Type 2 diabetes mellitus 228.45 14.40 561 86189 202683 90339014
Liver function test increased 226.97 14.40 339 86411 84516 90457181
Adverse reaction 226.56 14.40 204 86546 29508 90512189
Finger deformity 225.86 14.40 213 86537 32684 90509013
Migraine 219.81 14.40 531 86219 189861 90351836
Folliculitis 210.79 14.40 546 86204 203807 90337890
Live birth 197.36 14.40 306 86444 78801 90462896
Irritable bowel syndrome 195.47 14.40 536 86214 206912 90334785
Osteoarthritis 193.73 14.40 515 86235 195215 90346482
Hypoaesthesia 192.17 14.40 699 86051 313511 90228186
Psoriatic arthropathy 186.12 14.40 560 86190 227775 90313922
Product label confusion 184.37 14.40 162 86588 22688 90519009
Blood cholesterol increased 167.47 14.40 508 86242 207504 90334193
Muscle spasms 167.38 14.40 576 86174 251307 90290390
Gait inability 164.20 14.40 404 86346 146052 90395645
Fibromyalgia 162.55 14.40 500 86250 205769 90335928
Muscle injury 160.99 14.40 451 86299 176203 90365494
Depression 156.88 14.40 636 86114 299965 90241732
Pyrexia 156.79 14.40 244 86506 660241 89881456
Abdominal pain upper 151.29 14.40 675 86075 331999 90209698
Coeliac disease 150.12 14.40 199 86551 44411 90497286
Musculoskeletal pain 146.13 14.40 427 86323 170824 90370873
Grip strength decreased 139.12 14.40 287 86463 92289 90449408
Neutropenia 134.53 14.40 26 86724 224878 90316819
Intentional product use issue 132.87 14.40 483 86267 216409 90325288
Sleep disorder 131.62 14.40 453 86297 197577 90344120
Anaemia 125.12 14.40 93 86657 352709 90188988
Injection site reaction 123.98 14.40 273 86477 91807 90449890
Duodenal ulcer perforation 118.40 14.40 472 86278 220816 90320881
Acute kidney injury 116.80 14.40 82 86668 320305 90221392
Liver injury 116.67 14.40 394 86356 170173 90371524
Helicobacter infection 115.92 14.40 477 86273 226373 90315324
Thrombocytopenia 114.99 14.40 29 86721 208696 90333001
Pericarditis 112.99 14.40 535 86215 269616 90272081
Disease progression 112.95 14.40 10 86740 156605 90385092
Muscular weakness 112.32 14.40 443 86307 206223 90335474
Anti-cyclic citrullinated peptide antibody positive 112.15 14.40 486 86264 235947 90305750
Confusional state 112.13 14.40 692 86058 385513 90156184
Impaired healing 109.24 14.40 479 86271 233720 90307977
Blister 101.57 14.40 498 86252 254500 90287197
Overlap syndrome 97.16 14.40 74 86676 8474 90533223
Rheumatic fever 96.28 14.40 344 86406 152777 90388920
Drug-induced liver injury 95.76 14.40 244 86506 90074 90451623
Hepatic enzyme 95.33 14.40 61 86689 5283 90536414
Product use in unapproved indication 94.14 14.40 597 86153 335639 90206058
Pruritus 94.00 14.40 240 86510 541285 90000412
Febrile neutropenia 93.22 14.40 19 86731 158330 90383367
Synovitis 90.77 14.40 583 86167 329169 90212528
Hepatitis 88.80 14.40 204 86546 70535 90471162
Mobility decreased 88.22 14.40 473 86277 250261 90291436
Fatigue 87.65 14.40 697 86053 1153326 89388371
Drug ineffective 87.29 14.40 877 85873 1383421 89158276
Erythema 87.11 14.40 56 86694 229190 90312507
Lower respiratory tract infection 85.58 14.40 469 86281 250190 90291507
Wheezing 84.35 14.40 450 86300 237630 90304067
Maternal exposure during pregnancy 83.32 14.40 610 86140 359453 90182244
Hypocholesterolaemia 82.64 14.40 60 86690 6389 90535308
Pemphigus 80.99 14.40 563 86187 326301 90215396
Abdominal distension 80.89 14.40 292 86458 130309 90411388
Wound 80.52 14.40 531 86219 302449 90239248
Cough 78.45 14.40 146 86604 368816 90172881
Ill-defined disorder 77.85 14.40 367 86383 184524 90357173
Therapeutic product effect incomplete 77.40 14.40 379 86371 193517 90348180
Hypertension 75.86 14.40 719 86031 456813 90084884
Hypotension 75.33 14.40 122 86628 325275 90216422
Dyspepsia 73.93 14.40 380 86370 197780 90343917
Urinary retention 73.92 14.40 131 86619 37613 90504084
Glossodynia 72.63 14.40 542 86208 321237 90220460
General physical health deterioration 72.32 14.40 584 86166 354531 90187166
Urticaria 68.46 14.40 523 86227 312211 90229486
C-reactive protein abnormal 68.24 14.40 272 86478 127157 90414540
Respiratory failure 66.08 14.40 16 86734 118402 90423295
Drug abuse 66.05 14.40 3 86747 82344 90459353
Pancytopenia 63.77 14.40 18 86732 120245 90421452
Blood creatinine increased 62.14 14.40 11 86739 101375 90440322
Stomatitis 60.44 14.40 460 86290 274238 90267459
Sepsis 59.17 14.40 51 86699 179763 90361934
Drug interaction 59.08 14.40 109 86641 276344 90265353
Injection site pain 58.71 14.40 48 86702 173651 90368046
Hand deformity 57.42 14.40 482 86268 295880 90245817
Sinusitis 57.20 14.40 155 86595 342933 90198764
Rheumatoid arthritis 56.68 14.40 563 86187 362051 90179646
Weight decreased 56.56 14.40 181 86569 379729 90161968
Renal failure 55.48 14.40 28 86722 130979 90410718
Underdose 55.25 14.40 144 86606 53873 90487824
Infection 54.26 14.40 172 86578 361922 90179775
Haemoglobin decreased 53.21 14.40 46 86704 161910 90379787
Dehydration 52.83 14.40 65 86685 194382 90347315
Nausea 52.28 14.40 749 86001 1109567 89432130
Injury 51.84 14.40 345 86405 197004 90344693
Chills 51.83 14.40 31 86719 131950 90409747
Intentional overdose 51.73 14.40 13 86737 93821 90447876
Infusion related reaction 51.70 14.40 618 86132 416162 90125535
Systemic lupus erythematosus 51.38 14.40 551 86199 361345 90180352
Suicide attempt 51.27 14.40 6 86744 75393 90466304
Myalgia 50.30 14.40 56 86694 175069 90366628
Cardio-respiratory arrest 48.45 14.40 3 86747 63137 90478560
Leukopenia 48.23 14.40 18 86732 100692 90441005
Somnolence 45.95 14.40 81 86669 209003 90332694
Back pain 44.52 14.40 155 86595 317020 90224677
Normal newborn 44.35 14.40 80 86670 23282 90518415
Peripheral swelling 44.18 14.40 596 86154 412510 90129187
Cardiac arrest 43.57 14.40 23 86727 104912 90436785
Malignant neoplasm progression 43.54 14.40 24 86726 106846 90434851
Hyponatraemia 42.57 14.40 39 86711 133499 90408198
Aspartate aminotransferase increased 42.10 14.40 23 86727 102914 90438783
Seizure 41.48 14.40 51 86699 152578 90389119
Depressed level of consciousness 40.28 14.40 10 86740 72774 90468923
Neuropathy peripheral 40.22 14.40 43 86707 136927 90404770
Pulmonary embolism 39.62 14.40 40 86710 130780 90410917
Hepatic enzyme increased 39.20 14.40 522 86228 360214 90181483
Multiple organ dysfunction syndrome 38.58 14.40 9 86741 68327 90473370
Drug dispensed to wrong patient 38.25 14.40 14 86736 345 90541352
Arthritis 37.50 14.40 64 86686 167251 90374446
Myelosuppression 37.11 14.40 4 86746 53587 90488110
Platelet count decreased 36.97 14.40 46 86704 136923 90404774
Hyperhidrosis 36.56 14.40 46 86704 136259 90405438
Sleep disorder due to general medical condition, insomnia type 36.03 14.40 42 86708 128652 90413045
Residual urine volume increased 35.92 14.40 10 86740 97 90541600
Hyperkalaemia 35.80 14.40 9 86741 64955 90476742
White blood cell count decreased 35.58 14.40 66 86684 167043 90374654
Alanine aminotransferase increased 34.91 14.40 37 86713 118301 90423396
Death 34.32 14.40 276 86474 456275 90085422
Product dose omission issue 34.27 14.40 153 86597 291534 90250163
Urinary incontinence 34.25 14.40 96 86654 37470 90504227
Congenital anomaly 34.13 14.40 36 86714 6311 90535386
Rash erythematous 34.04 14.40 10 86740 65094 90476603
Incorrect product administration duration 33.96 14.40 64 86686 19258 90522439
Bradycardia 32.49 14.40 20 86730 83827 90457870
Hypokalaemia 32.38 14.40 47 86703 131069 90410628
Injection site erythema 32.32 14.40 28 86722 98474 90443223
Dyspnoea 32.25 14.40 622 86128 880333 89661364
Pain in jaw 32.18 14.40 4 86746 47981 90493716
Antineutrophil cytoplasmic antibody increased 32.01 14.40 11 86739 224 90541473
Septic shock 31.35 14.40 21 86729 84139 90457558
Anaphylactic reaction 31.07 14.40 23 86727 87501 90454196
Upper respiratory tract infection 30.71 14.40 47 86703 128271 90413426
Metabolic acidosis 30.13 14.40 8 86742 55668 90486029
Pleural effusion 29.82 14.40 38 86712 111953 90429744
Influenza 29.65 14.40 55 86695 139209 90402488
Chest discomfort 29.14 14.40 55 86695 138310 90403387
Neoplasm progression 29.13 14.40 4 86746 44482 90497215
Therapeutic product effect decreased 29.04 14.40 399 86351 277172 90264525
Haematochezia 28.77 14.40 16 86734 70897 90470800
Oedema peripheral 28.68 14.40 138 86612 257777 90283920
Drug intolerance 28.68 14.40 594 86156 446997 90094700
Syncope 28.59 14.40 52 86698 132611 90409086
Psoriasis 28.34 14.40 62 86688 147692 90394005
Gastrointestinal haemorrhage 28.01 14.40 27 86723 90221 90451476
Sedation 27.88 14.40 6 86744 48165 90493532
Ascites 27.52 14.40 6 86744 47734 90493963
Hepatic failure 27.42 14.40 3 86747 39725 90501972
Multiple sclerosis 27.23 14.40 73 86677 27767 90513930
Sinonasal obstruction 27.07 14.40 10 86740 253 90541444
Bronchitis 27.06 14.40 67 86683 152860 90388837
On and off phenomenon 26.69 14.40 21 86729 2522 90539175
Asthenia 26.36 14.40 683 86067 533068 90008629
Contraindicated product administered 25.72 14.40 440 86310 319699 90221998
Skin ulcer 25.62 14.40 8 86742 50067 90491630
Breast cancer stage II 25.35 14.40 83 86667 35251 90506446
Pulmonary hypertension 25.23 14.40 5 86745 42518 90499179
Pulmonary oedema 25.20 14.40 14 86736 62066 90479631
Myocardial infarction 25.18 14.40 39 86711 105933 90435764
Scleral discolouration 24.82 14.40 11 86739 450 90541247
Dyspnoea exertional 24.39 14.40 20 86730 72268 90469429
Diarrhoea 24.34 14.40 699 86051 938491 89603206
Herpes zoster 24.29 14.40 33 86717 94611 90447086
Dizziness 24.06 14.40 736 86014 588548 89953149
Blood bilirubin increased 24.00 14.40 6 86744 43464 90498233
Fall 23.91 14.40 617 86133 481193 90060504
Bone pain 23.72 14.40 15 86735 61968 90479729
Blood glucose increased 23.65 14.40 34 86716 95212 90446485
Cardiac failure 23.52 14.40 43 86707 109453 90432244
Nasopharyngitis 23.42 14.40 532 86218 406572 90135125
Therapeutic response decreased 23.32 14.40 31 86719 89698 90451999
Bladder pain 23.27 14.40 20 86730 2717 90538980
Disease recurrence 23.25 14.40 4 86746 37649 90504048
Swelling face 22.29 14.40 27 86723 81325 90460372
Respiratory distress 22.24 14.40 5 86745 38941 90502756
Constipation 22.22 14.40 167 86583 280228 90261469
Cholestasis 22.10 14.40 4 86746 36295 90505402
Influenza like illness 21.82 14.40 27 86723 80584 90461113
Asthma 21.76 14.40 139 86611 242021 90299676
Skin exfoliation 21.44 14.40 20 86730 67893 90473804
Macular degeneration 21.43 14.40 5 86745 37965 90503732
Renal impairment 21.25 14.40 43 86707 105378 90436319
Cerebrovascular accident 21.17 14.40 55 86695 123478 90418219
Staphylococcal infection 21.03 14.40 10 86740 48429 90493268
Sputum retention 20.97 14.40 11 86739 655 90541042
Hypoxia 20.95 14.40 23 86727 72376 90469321
Transaminases increased 20.79 14.40 5 86745 37187 90504510
Lymphadenopathy 20.58 14.40 9 86741 45766 90495931
Osteonecrosis of jaw 20.45 14.40 6 86744 39097 90502600
Neutrophil count decreased 20.39 14.40 23 86727 71509 90470188
Chest pain 20.16 14.40 202 86548 319443 90222254
Plasma cell myeloma 20.05 14.40 7 86743 40821 90500876
Swelling 20.02 14.40 534 86216 418524 90123173
Anxiety 19.85 14.40 195 86555 309577 90232120
Agitation 19.76 14.40 21 86729 67077 90474620
Cholelithiasis 19.69 14.40 13 86737 52493 90489204
Drug tolerance 19.60 14.40 49 86701 17867 90523830
Respiratory arrest 19.59 14.40 4 86746 33307 90508390
Encephalopathy 19.54 14.40 10 86740 46434 90495263
Hypoglycaemia 19.33 14.40 23 86727 69825 90471872
Dysphagia 19.23 14.40 50 86700 112228 90429469
Adverse event 19.12 14.40 184 86566 117234 90424463
Toxic epidermal necrolysis 18.93 14.40 4 86746 32524 90509173
Abdominal pain 18.84 14.40 266 86484 395455 90146242
Treatment failure 18.68 14.40 401 86349 303527 90238170
Epistaxis 18.67 14.40 33 86717 85092 90456605
Cataract 18.64 14.40 25 86725 72067 90469630
Oedema 18.50 14.40 114 86636 200181 90341516
Colitis 18.34 14.40 24 86726 69918 90471779
Oxygen saturation decreased 18.31 14.40 48 86702 107435 90434262
Mental status changes 18.24 14.40 10 86740 44669 90497028
Haematemesis 17.96 14.40 5 86745 33721 90507976
Deep vein thrombosis 17.93 14.40 38 86712 91582 90450115
Intercepted medication error 17.91 14.40 11 86739 886 90540811
Arthropathy 17.86 14.40 468 86282 365774 90175923
Acute respiratory distress syndrome 17.82 14.40 3 86747 28683 90513014
Leukocytosis 17.65 14.40 4 86746 30986 90510711
Weight increased 17.57 14.40 524 86226 417403 90124294
Drug eruption 17.51 14.40 6 86744 35401 90506296
Interstitial lung disease 17.32 14.40 29 86721 76376 90465321
Vascular stenosis 17.30 14.40 9 86741 527 90541170
Liver function test abnormal 17.23 14.40 14 86736 50831 90490866
Exostosis 17.15 14.40 98 86652 53036 90488661
Lactic acidosis 16.97 14.40 14 86736 50449 90491248
Loss of consciousness 16.79 14.40 73 86677 140165 90401532
Sinus congestion 16.75 14.40 3 86747 27421 90514276
Blood alkaline phosphatase increased 16.59 14.40 13 86737 48066 90493631
Hypercalcaemia 16.59 14.40 6 86744 34234 90507463
Hypersensitivity 16.58 14.40 321 86429 454356 90087341
Colitis ulcerative 16.51 14.40 20 86730 60246 90481451
Injection site swelling 16.24 14.40 20 86730 59819 90481878
Rheumatoid factor positive 16.21 14.40 97 86653 171553 90370144
Haematocrit decreased 16.17 14.40 10 86740 41822 90499875
Clostridium difficile colitis 16.14 14.40 3 86747 26703 90514994
Blood pressure orthostatic decreased 16.11 14.40 7 86743 273 90541424
Irritability 16.05 14.40 7 86743 35655 90506042
Haemorrhage 16.03 14.40 26 86724 69343 90472354
Hypomagnesaemia 15.99 14.40 7 86743 35581 90506116
Drug withdrawal syndrome 15.79 14.40 4 86746 28719 90512978
Ejection fraction decreased 15.76 14.40 3 86747 26250 90515447
Eosinophilia 15.63 14.40 4 86746 28529 90513168
Ulcer haemorrhage 15.56 14.40 58 86692 26263 90515434
Thrombosis 15.52 14.40 29 86721 73222 90468475
Blood lactate dehydrogenase increased 15.49 14.40 3 86747 25929 90515768
Red blood cell count decreased 15.42 14.40 13 86737 46338 90495359
Blood urea increased 15.31 14.40 5 86745 30408 90511289
Skin disorder 15.30 14.40 8 86742 36698 90504999
Emotional distress 15.27 14.40 8 86742 36654 90505043
Incorrect dose administered 15.23 14.40 33 86717 78897 90462800
Pneumonitis 15.17 14.40 12 86738 44158 90497539
Freezing phenomenon 14.92 14.40 13 86737 1799 90539898
International normalised ratio increased 14.86 14.40 14 86736 47302 90494395
Dislocation of vertebra 14.77 14.40 98 86652 55870 90485827
Injection site bruising 14.71 14.40 17 86733 52290 90489407
Diverticulitis 14.63 14.40 13 86737 45174 90496523
Atrial fibrillation 14.55 14.40 72 86678 133539 90408158
Stevens-Johnson syndrome 14.49 14.40 5 86745 29371 90512326

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
Urinary retention 242.79 15.65 154 12757 42060 42566364
Fall 155.05 15.65 264 12647 234256 42374168
Hallucination 101.33 15.65 105 12806 57402 42551022
Confusional state 69.19 15.65 155 12756 167442 42440982
Nocturia 49.92 15.65 36 12875 12076 42596348
Urinary tract infection 46.84 15.65 97 12814 99187 42509237
Urinary incontinence 44.44 15.65 43 12868 21625 42586799
Platypnoea 43.96 15.65 8 12903 32 42608392
Muscular dystrophy 39.01 15.65 9 12902 135 42608289
Arrhythmia 37.07 15.65 53 12858 40264 42568160
Pollakiuria 35.88 15.65 39 12872 22466 42585958
Gait disturbance 34.22 15.65 85 12826 97915 42510509
On and off phenomenon 34.21 15.65 18 12893 3449 42604975
Head injury 33.39 15.65 36 12875 20546 42587878
Phaeochromocytoma malignant 33.14 15.65 7 12904 68 42608356
Dementia 32.47 15.65 32 12879 16448 42591976
Intentional product misuse 32.18 15.65 63 12848 61837 42546587
Delusion 31.65 15.65 30 12881 14704 42593720
Orthostatic hypotension 30.80 15.65 42 12869 30528 42577896
Device dislocation 29.39 15.65 22 12889 7809 42600615
Dropped head syndrome 29.17 15.65 8 12903 248 42608176
Micturition urgency 29 15.65 26 12885 11872 42596552
Constipation 28.71 15.65 111 12800 162180 42446244
Dysuria 25.86 15.65 39 12872 31057 42577367
Blood pressure increased 25.25 15.65 78 12833 101850 42506574
Muscle spasticity 25.23 15.65 19 12892 6803 42601621
Erectile dysfunction 24.75 15.65 34 12877 24879 42583545
Muscular weakness 24.61 15.65 68 12843 83430 42524994
Neurogenic bladder 23.06 15.65 12 12899 2248 42606176
Bone marrow oedema 22.97 15.65 9 12902 868 42607556
Spinal cord haemorrhage 22.87 15.65 7 12904 322 42608102
Oesophageal obstruction 22.43 15.65 8 12903 594 42607830
Hypertensive crisis 22.34 15.65 21 12890 10185 42598239
Toxicity to various agents 22.22 15.65 22 12889 229114 42379310
Mobility decreased 22.18 15.65 39 12872 35267 42573157
Embedded device 20.83 15.65 7 12904 435 42607989
Cerebral infarction 20.32 15.65 35 12876 31134 42577290
Oesophageal dilatation 20.19 15.65 6 12905 249 42608175
Dysstasia 20.03 15.65 23 12888 14063 42594361
Dizziness 19.68 15.65 136 12775 249118 42359306
Multiple organ dysfunction syndrome 19.58 15.65 3 12908 97032 42511392
Extradural haematoma 19.23 15.65 9 12902 1342 42607082
Asthenia 19.19 15.65 148 12763 280645 42327779
Dry mouth 18.82 15.65 39 12872 39840 42568584
Stoma site discharge 18.47 15.65 9 12902 1467 42606957
Dyskinesia oesophageal 18.09 15.65 4 12907 49 42608375
Cystitis interstitial 17.79 15.65 5 12906 170 42608254
Delirium 17.73 15.65 45 12866 52474 42555950
Blood pressure systolic increased 17.71 15.65 31 12880 27937 42580487
Product use complaint 17.62 15.65 10 12901 2221 42606203
Completed suicide 17.29 15.65 4 12907 96461 42511963
Bladder spasm 17.18 15.65 8 12903 1179 42607245
Intentional medical device removal by patient 17.03 15.65 6 12905 430 42607994
Hypertonic bladder 17.02 15.65 10 12901 2371 42606053
Humerus fracture 16.63 15.65 11 12900 3209 42605215
Inhibitory drug interaction 16.44 15.65 9 12902 1865 42606559
Product confusion 16.35 15.65 5 12906 229 42608195
Capillary leak syndrome 15.83 15.65 10 12901 2697 42605727
Blood prolactin decreased 15.78 15.65 5 12906 258 42608166

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
Blepharospasm 855.06 13.24 544 90752 54307 110443696
Taste disorder 717.63 13.24 522 90774 64865 110433138
Onychomadesis 650.38 13.24 428 90868 45235 110452768
Epilepsy 536.35 13.24 529 90767 99680 110398323
Nail disorder 532.41 13.24 416 90880 57519 110440484
Breast cancer stage III 496.29 13.24 456 90840 78661 110419342
Back injury 489.76 13.24 365 90931 47034 110450969
Peripheral venous disease 483.81 13.24 462 90834 83655 110414348
Product quality issue 449.19 13.24 427 90869 76872 110421131
Gastrooesophageal reflux disease 441.61 13.24 638 90658 179338 110318665
Onychomycosis 439.49 13.24 315 90981 38216 110459787
Facet joint syndrome 429.24 13.24 462 90834 96366 110401637
Hypercholesterolaemia 428.53 13.24 448 90848 90389 110407614
Bursitis 401.19 13.24 515 90781 129403 110368600
Wound infection 373.74 13.24 429 90867 96036 110401967
Memory impairment 366.92 13.24 615 90681 196329 110301674
Obesity 336.91 13.24 441 90855 112910 110385093
Type 2 diabetes mellitus 333.51 13.24 556 90740 176676 110321327
Folliculitis 330.35 13.24 537 90759 167116 110330887
Lip dry 306.18 13.24 395 90901 99688 110398315
Irritable bowel syndrome 306.06 13.24 513 90783 163702 110334301
Toxicity to various agents 303.37 13.24 25 91271 480530 110017473
Dry mouth 302.37 13.24 570 90726 199378 110298625
Night sweats 294.11 13.24 451 90845 133532 110364471
C-reactive protein increased 290.39 13.24 589 90707 217330 110280673
Joint range of motion decreased 290.10 13.24 426 90870 121406 110376597
Psoriatic arthropathy 277.97 13.24 545 90751 196216 110301787
Osteoarthritis 277.82 13.24 522 90774 182101 110315902
Neck pain 270.99 13.24 415 90881 122715 110375288
Muscle injury 267.86 13.24 444 90852 140363 110357640
Migraine 262.79 13.24 492 90804 171160 110326843
Finger deformity 258.14 13.24 216 91080 32876 110465127
Adverse reaction 255.68 13.24 205 91091 29389 110468614
Inflammation 251.14 13.24 517 90779 192721 110305282
Pemphigus 249.91 13.24 549 90747 214021 110283982
Fibromyalgia 249.42 13.24 480 90816 170429 110327574
Liver function test increased 246.92 13.24 334 90962 88214 110409789
Paraesthesia 241.78 13.24 633 90663 275888 110222115
Hypoaesthesia 233.76 13.24 678 90618 313545 110184458
Live birth 231.14 13.24 286 91010 69198 110428805
Infusion site reaction 230.65 13.24 157 91139 17525 110480478
Blood cholesterol increased 230.30 13.24 486 90810 184299 110313704
Glossodynia 228.58 13.24 541 90755 221463 110276540
Helicobacter infection 227.42 13.24 479 90817 181398 110316605
Anti-cyclic citrullinated peptide antibody positive 227.23 13.24 479 90817 181505 110316498
Lung disorder 220.28 13.24 470 90826 179577 110318426
Maternal exposure during pregnancy 211.16 13.24 572 90724 254311 110243692
Pericarditis 210.62 13.24 520 90776 218594 110279409
Gait inability 210.06 13.24 392 90904 135984 110362019
Duodenal ulcer perforation 206.11 13.24 454 90842 177246 110320757
Product label confusion 204.27 13.24 161 91135 22516 110475487
Impaired healing 203.15 13.24 480 90816 196237 110301766
Grip strength decreased 193.18 13.24 282 91014 79892 110418111
Wound 193.05 13.24 525 90771 233912 110264091
Synovitis 191.96 13.24 579 90717 273513 110224490
Muscle spasms 187.71 13.24 580 90716 277577 110220426
Systemic lupus erythematosus 180.66 13.24 540 90756 253798 110244205
Completed suicide 180.66 13.24 4 91292 242377 110255626
Pyrexia 178.53 13.24 292 91004 897973 109600030
Liver injury 177.48 13.24 387 90909 150026 110347977
Coeliac disease 177.26 13.24 198 91098 42989 110455014
Musculoskeletal pain 171.25 13.24 430 90866 182593 110315410
Abdominal pain upper 170.85 13.24 654 90642 348457 110149546
Anaemia 170.56 13.24 122 91174 546964 109951039
Depression 169.92 13.24 612 90684 316723 110181280
Hand deformity 168.69 13.24 478 90818 218028 110279975
Acute kidney injury 165.99 13.24 168 91128 635262 109862741
Rheumatic fever 165.13 13.24 333 90963 122246 110375757
Confusional state 164.62 13.24 794 90502 467886 110030117
Injection site reaction 161.50 13.24 275 91021 88795 110409208
Sleep disorder 160.66 13.24 442 90854 198202 110299801
Blister 156.97 13.24 478 90818 226898 110271105
Thrombocytopenia 156.13 13.24 47 91249 348838 110149165
Neutropenia 151.21 13.24 60 91236 374560 110123443
Mobility decreased 146.36 13.24 480 90816 236942 110261061
Ill-defined disorder 140.97 13.24 363 90933 156490 110341513
Rheumatoid arthritis 138.98 13.24 552 90744 299061 110198942
Muscular weakness 136.20 13.24 483 90813 247985 110250018
Lower respiratory tract infection 131.90 13.24 471 90825 242635 110255368
Intentional product use issue 131.69 13.24 477 90819 247429 110250574
Febrile neutropenia 129.03 13.24 50 91246 316717 110181286
Urinary retention 115.71 13.24 207 91089 69476 110428527
Infusion related reaction 106.95 13.24 607 90689 380555 110117448
Hepatic enzyme 105.61 13.24 61 91235 5102 110492901
Overlap syndrome 105.41 13.24 75 91221 8984 110489019
Wheezing 104.77 13.24 453 90843 254777 110243226
C-reactive protein abnormal 103.23 13.24 287 91009 129408 110368595
Stomatitis 100.67 13.24 466 90830 269776 110228227
Contraindicated product administered 98.36 13.24 436 90860 247831 110250172
Hypotension 96.80 13.24 178 91118 523671 109974332
Hypertension 93.81 13.24 731 90565 509353 109988650
Hepatic enzyme increased 92.61 13.24 515 90781 320377 110177626
Disease progression 92.19 13.24 43 91253 243991 110254012
Drug-induced liver injury 91.93 13.24 262 91034 119805 110378198
Hypocholesterolaemia 90.91 13.24 60 91236 6361 110491642
Sepsis 89.45 13.24 83 91213 327263 110170740
Urticaria 88.89 13.24 507 90789 318350 110179653
Pancytopenia 88.85 13.24 31 91265 209582 110288421
Multiple organ dysfunction syndrome 87.56 13.24 11 91285 151699 110346304
Injury 87.33 13.24 333 90963 176932 110321071
Drug interaction 86.29 13.24 177 91119 500006 109997997
Peripheral swelling 85.64 13.24 599 90697 403435 110094568
Dyspepsia 85.41 13.24 348 90948 190617 110307386
Hepatitis 84.60 13.24 212 91084 89842 110408161
Arthropathy 83.32 13.24 462 90834 287060 110210943
Swelling 80.68 13.24 531 90765 350510 110147493
Erythema 79.50 13.24 74 91222 291373 110206630
General physical health deterioration 78.98 13.24 611 90685 424684 110073319
Renal failure 78.05 13.24 45 91251 226529 110271474
Fall 76.17 13.24 797 90499 602685 109895318
Coma 74.64 13.24 6 91290 117863 110380140
Respiratory failure 73.84 13.24 43 91253 215289 110282714
Cough 72.51 13.24 172 91124 461469 110036534
Underdose 68.71 13.24 158 91138 63396 110434607
Haemoglobin decreased 68.01 13.24 63 91233 248664 110249339
Cardio-respiratory arrest 67.82 13.24 8 91288 115828 110382175
Therapeutic product effect incomplete 67.76 13.24 364 90932 223441 110274562
Leukopenia 66.59 13.24 20 91276 148771 110349232
Pruritus 64.67 13.24 254 91042 581306 109916697
Platelet count decreased 64.64 13.24 57 91239 230386 110267617
Therapeutic product effect decreased 64.49 13.24 383 90913 243933 110254070
Cardiac arrest 63.70 13.24 42 91254 196711 110301292
Abdominal discomfort 63.48 13.24 548 90748 393310 110104693
Alopecia 63.29 13.24 516 90780 364237 110133766
Product use in unapproved indication 62.24 13.24 603 90693 446774 110051229
Pulmonary embolism 60.21 13.24 53 91243 214421 110283582
Nasopharyngitis 60.09 13.24 542 90754 393819 110104184
Drug intolerance 60.06 13.24 555 90741 405957 110092046
Myelosuppression 59.18 13.24 5 91291 94335 110403668
Weight decreased 58.94 13.24 194 91102 467863 110030140
Normal newborn 58.59 13.24 81 91215 21815 110476188
Suicide attempt 58.45 13.24 8 91288 103386 110394617
Dehydration 58.03 13.24 88 91208 279423 110218580
Mucosal inflammation 57.90 13.24 6 91290 96135 110401868
Intentional overdose 57.17 13.24 19 91277 132482 110365521
Aspartate aminotransferase increased 56.17 13.24 31 91265 159905 110338098
Pleural effusion 56.10 13.24 39 91257 177670 110320333
Seizure 55.90 13.24 60 91236 221125 110276878
Myalgia 55.46 13.24 61 91235 222320 110275683
Drug reaction with eosinophilia and systemic symptoms 55.44 13.24 3 91293 82092 110415911
Abdominal distension 55.19 13.24 288 91008 174815 110323188
Chills 54.83 13.24 46 91250 190534 110307469
Blood creatinine increased 54.04 13.24 43 91253 182846 110315157
Neuropathy peripheral 53.16 13.24 42 91254 179235 110318768
Hyponatraemia 52.86 13.24 61 91235 217592 110280411
Metabolic acidosis 51.29 13.24 10 91286 99734 110398269
Haematochezia 50.84 13.24 16 91280 115508 110382495
Drug ineffective 50.65 13.24 918 90378 1519622 108978381
Injection site pain 49.90 13.24 44 91252 177878 110320125
White blood cell count decreased 49.78 13.24 70 91226 229320 110268683
Alanine aminotransferase increased 48.53 13.24 48 91248 183725 110314278
Blood bilirubin increased 47.73 13.24 4 91292 75968 110422035
Malignant neoplasm progression 46.79 13.24 45 91251 174522 110323481
Ascites 46.28 13.24 10 91286 92798 110405205
Bradycardia 45.40 13.24 37 91259 155480 110342523
Septic shock 45.34 13.24 38 91258 157490 110340513
Exposure during pregnancy 45.15 13.24 264 91032 167160 110330843
Treatment failure 44.76 13.24 386 90910 276848 110221155
Myocardial infarction 44.34 13.24 56 91240 192027 110305976
Urinary incontinence 43.15 13.24 112 91184 48475 110449528
Hyperkalaemia 42.60 13.24 30 91266 135766 110362237
Weight increased 42.40 13.24 531 90765 419113 110078890
Gastrointestinal haemorrhage 41.71 13.24 45 91251 165473 110332530
Joint swelling 41.64 13.24 553 90743 442292 110055711
Hypoxia 41.44 13.24 28 91268 129487 110368516
Death 41.05 13.24 374 90922 698495 109799508
Hepatotoxicity 40.78 13.24 3 91293 63397 110434606
Incorrect product administration duration 39.41 13.24 65 91231 20433 110477570
Cholestasis 38.92 13.24 4 91292 64514 110433489
Hepatic failure 37.28 13.24 6 91290 68733 110429270
Infection 37.22 13.24 163 91133 362037 110135966
Lactic acidosis 37.18 13.24 15 91281 92796 110405207
Platypnoea 35.95 13.24 8 91288 32 110497971
Somnolence 35.56 13.24 126 91170 297323 110200680
Product use issue 34.78 13.24 402 90894 311293 110186710
On and off phenomenon 34.74 13.24 29 91267 4395 110493608
Asthenia 34.71 13.24 778 90518 688221 109809782
Dizziness 34.43 13.24 786 90510 697407 109800596
Dyspnoea 34.35 13.24 676 90620 1106196 109391807
Chest pain 34.21 13.24 177 91119 376198 110121805
Cytokine release syndrome 34.20 13.24 8 91288 70298 110427705
Bone marrow failure 33.85 13.24 4 91292 57844 110440159
Back pain 33.42 13.24 175 91121 370821 110127182
Rash erythematous 33.15 13.24 13 91283 81819 110416184
Toxic epidermal necrolysis 33 13.24 4 91292 56723 110441280
Hypokalaemia 32.75 13.24 63 91233 182385 110315618
Residual urine volume increased 32.70 13.24 9 91287 98 110497905
Neutrophil count decreased 32.61 13.24 31 91265 120910 110377093
Hyperhidrosis 32.48 13.24 66 91230 187232 110310771
Chest discomfort 32.11 13.24 59 91237 173789 110324214
Nausea 31.92 13.24 777 90519 1234913 109263090
Pulmonary oedema 31.88 13.24 22 91274 100637 110397366
Respiratory arrest 31.82 13.24 5 91291 58294 110439709
International normalised ratio increased 31.67 13.24 16 91280 86756 110411247
Haemorrhage 31.62 13.24 25 91271 106667 110391336
Adverse event 31.58 13.24 175 91121 108634 110389369
Sinusitis 31.40 13.24 132 91164 296556 110201447
Depressed level of consciousness 31.20 13.24 28 91268 112250 110385753
Haemoptysis 31.19 13.24 10 91286 71344 110426659
Epistaxis 31.15 13.24 37 91259 130335 110367668
Drug dispensed to wrong patient 30.30 13.24 14 91282 735 110497268
Bladder pain 29.85 13.24 22 91274 2783 110495220
Transaminases increased 29.32 13.24 8 91288 63382 110434621
Gastrointestinal disorder 28.77 13.24 316 90980 241636 110256367
Hepatocellular injury 28.43 13.24 4 91292 50638 110447365
Neoplasm progression 28.32 13.24 9 91287 64586 110433417
Injection site erythema 27.99 13.24 22 91274 94154 110403849
Arthritis 27.43 13.24 61 91235 167525 110330478
Pulmonary hypertension 27.43 13.24 6 91290 55214 110442789
Eosinophilia 27.39 13.24 7 91289 57929 110440074
Abdominal pain 27.34 13.24 281 91015 512708 109985295
Fatigue 26.82 13.24 782 90514 1215176 109282827
Sedation 26.73 13.24 12 91284 69671 110428332
Encephalopathy 26.64 13.24 17 91279 81038 110416965
Leukocytosis 26.43 13.24 6 91290 53822 110444181
Haematemesis 26.34 13.24 8 91288 59100 110438903
Phaeochromocytoma malignant 26.16 13.24 7 91289 68 110497935
Acute respiratory distress syndrome 25.98 13.24 6 91290 53192 110444811
Drug dependence 25.74 13.24 5 91291 50015 110447988
Blood glucose increased 25.34 13.24 44 91252 132452 110365551
Muscular dystrophy 25.26 13.24 9 91287 239 110497764
Ulcer 25.18 13.24 3 91293 43113 110454890
Renal impairment 25.16 13.24 76 91220 188369 110309634
Hyperglycaemia 25.13 13.24 20 91276 85070 110412933
Pneumocystis jirovecii pneumonia 24.89 13.24 3 91293 42732 110455271
Oedema peripheral 24.82 13.24 164 91132 328496 110169507
Anaphylactic shock 24.81 13.24 6 91290 51540 110446463
Hypertonic bladder 24.71 13.24 26 91270 5276 110492727
Respiratory distress 24.69 13.24 13 91283 68861 110429142
Hypoglycaemia 24.62 13.24 36 91260 116068 110381935
Reaction to preservatives 24.57 13.24 9 91287 259 110497744
Skin ulcer 24.35 13.24 11 91285 63634 110434369
Disease recurrence 24.06 13.24 10 91286 60774 110437229
Rash maculo-papular 23.80 13.24 16 91280 74206 110423797
Hypomagnesaemia 23.79 13.24 10 91286 60360 110437643
Pancreatitis acute 23.72 13.24 10 91286 60264 110437739
Deep vein thrombosis 23.65 13.24 50 91246 139837 110358166
Coronary artery disease 23.61 13.24 15 91281 71675 110426328
Product dose omission issue 23.58 13.24 162 91134 321620 110176383
Cerebrovascular accident 23.57 13.24 74 91222 181210 110316793
Blood urea increased 23.49 13.24 8 91288 54949 110443054
Influenza 23.45 13.24 67 91229 169034 110328969
Anxiety 23.23 13.24 178 91118 344900 110153103
Haematocrit decreased 22.94 13.24 13 91283 66104 110431899
Bacterial infection 22.87 13.24 5 91291 46031 110451972
Pain in jaw 22.67 13.24 7 91289 51170 110446833
Dyspnoea exertional 22.32 13.24 32 91264 104028 110393975
Liver function test abnormal 21.93 13.24 15 91281 68935 110429068
Skin exfoliation 21.89 13.24 24 91272 87627 110410376
Acute respiratory failure 21.84 13.24 18 91278 75242 110422761
Anaphylactic reaction 21.82 13.24 38 91258 114262 110383741
Blood lactate dehydrogenase increased 21.65 13.24 5 91291 44329 110453674
Herpes zoster 21.64 13.24 35 91261 108344 110389659
Stevens-Johnson syndrome 21.54 13.24 6 91290 46895 110451108
Jaundice 21.50 13.24 11 91285 59225 110438778
Syncope 21.49 13.24 90 91206 202446 110295557
Tubulointerstitial nephritis 21.37 13.24 9 91287 54275 110443728
Hypercalcaemia 21.37 13.24 6 91290 46651 110451352
Upper respiratory tract infection 21.33 13.24 48 91248 131280 110366723
Sinonasal obstruction 21.32 13.24 9 91287 380 110497623
Coagulopathy 21.25 13.24 4 91292 40907 110457096
Rhabdomyolysis 21.23 13.24 42 91254 120359 110377644
Staphylococcal infection 21.22 13.24 16 91280 69928 110428075
Plasma cell myeloma 20.95 13.24 13 91283 62923 110435080
Thrombosis 20.85 13.24 36 91260 108626 110389377
Dislocation of vertebra 20.58 13.24 81 91215 43640 110454363
Blood alkaline phosphatase increased 20.54 13.24 17 91279 70918 110427085
Breast cancer stage II 20.22 13.24 59 91237 27316 110470687
Ventricular tachycardia 20.16 13.24 8 91288 50001 110448002
Lymphadenopathy 20.15 13.24 14 91282 63821 110434182
Unresponsive to stimuli 20.12 13.24 14 91282 63776 110434227
Eczema 20.12 13.24 18 91278 72275 110425728
Subcutaneous drug absorption impaired 19.99 13.24 28 91268 7631 110490372
Antineutrophil cytoplasmic antibody increased 19.80 13.24 8 91288 302 110497701
Multiple sclerosis 19.58 13.24 56 91240 25642 110472361
Salpingo-oophorectomy bilateral 19.53 13.24 8 91288 313 110497690
Drug eruption 19.42 13.24 10 91286 53649 110444354
Cardiac failure congestive 19.38 13.24 62 91234 150938 110347065
Shock 19.38 13.24 10 91286 53578 110444425
Scleral discolouration 19.36 13.24 10 91286 670 110497333
Chronic obstructive pulmonary disease 19.32 13.24 38 91258 109120 110388883
Obstructive airways disorder 19.24 13.24 7 91289 46142 110451861
Stress 19.23 13.24 36 91260 105312 110392691
Ejection fraction decreased 19.21 13.24 5 91291 40875 110457128
Drug withdrawal syndrome 19.18 13.24 4 91292 38050 110459953
Irritability 18.71 13.24 8 91288 47801 110450202
Upper gastrointestinal haemorrhage 18.64 13.24 9 91287 50087 110447916
Diarrhoea 18.56 13.24 761 90535 1138744 109359259
Cardiac failure 18.32 13.24 86 91210 187540 110310463
Influenza like illness 18.17 13.24 28 91268 88384 110409619
Dyskinesia oesophageal 18.12 13.24 5 91291 55 110497948
Cardiomyopathy 18.01 13.24 3 91293 33522 110464481
Hallucination 17.82 13.24 144 91152 101288 110396715
Mental status changes 17.76 13.24 22 91274 76100 110421903
Red blood cell count decreased 17.65 13.24 17 91279 65906 110432097
Blood calcium decreased 17.59 13.24 4 91292 35841 110462162
Incorrect dose administered 17.56 13.24 37 91259 103604 110394399
Pericardial effusion 17.47 13.24 13 91283 57204 110440799
Cholelithiasis 17.40 13.24 16 91280 63406 110434597
Asthma 17.36 13.24 128 91168 250163 110247840
Serotonin syndrome 17.35 13.24 14 91282 59139 110438864
Inappropriate schedule of product administration 17.25 13.24 98 91198 203539 110294464
Suicidal ideation 17.24 13.24 32 91264 93905 110404098
Bone pain 17.20 13.24 17 91279 65116 110432887
Drug level increased 17.11 13.24 9 91287 47710 110450293
Skin disorder 17.08 13.24 7 91289 42906 110455097
Respiratory depression 16.90 13.24 3 91293 31998 110466005
Intentional self-injury 16.80 13.24 5 91291 37424 110460579
Tachycardia 16.65 13.24 114 91182 226531 110271472
Therapy non-responder 16.62 13.24 70 91226 157237 110340766
Oxygen saturation decreased 16.50 13.24 70 91226 156912 110341091
Heart rate increased 16.47 13.24 62 91234 143772 110354231
Agranulocytosis 16.45 13.24 16 91280 61744 110436259
Freezing phenomenon 16.27 13.24 15 91281 2594 110495409
Pollakiuria 16.27 13.24 76 91220 44119 110453884
Agitation 16.26 13.24 44 91252 113007 110384996
Exostosis 16.17 13.24 78 91218 45878 110452125
Blood creatine phosphokinase increased 16.14 13.24 22 91274 73055 110424948
Acute hepatic failure 16.13 13.24 5 91291 36463 110461540
Colitis 16.13 13.24 38 91258 102285 110395718
Ischaemic stroke 15.99 13.24 7 91289 41256 110456747
Cellulitis 15.99 13.24 52 91244 125964 110372039
Sinus congestion 15.77 13.24 3 91293 30456 110467547
Micturition urgency 15.60 13.24 43 91253 19277 110478726
Myoclonus 15.57 13.24 4 91292 32994 110465009
Dysgeusia 15.53 13.24 21 91275 69964 110428039
Cytopenia 15.52 13.24 3 91293 30113 110467890
Myocarditis 15.48 13.24 3 91293 30052 110467951
Hypervolaemia 15.41 13.24 11 91285 49449 110448554
Vascular stenosis 15.40 13.24 9 91287 769 110497234
Gastritis 15.39 13.24 13 91283 53686 110444317
Emotional distress 15.30 13.24 9 91287 44838 110453165
Sleep disorder due to general medical condition, insomnia type 15.28 13.24 41 91255 105602 110392401
Proteinuria 15.18 13.24 7 91289 40011 110457992
Myelodysplastic syndrome 15.11 13.24 6 91290 37478 110460525
Gamma-glutamyltransferase increased 15.07 13.24 17 91279 61292 110436711
Hepatic function abnormal 15.02 13.24 32 91264 89263 110408740
Pneumonitis 15.01 13.24 25 91271 76506 110421497
Psoriasis 14.98 13.24 62 91234 139931 110358072
Nocturia 14.91 13.24 39 91257 16951 110481052
Melaena 14.89 13.24 21 91275 68736 110429267
Therapy partial responder 14.82 13.24 6 91290 37055 110460948
Generalised tonic-clonic seizure 14.76 13.24 14 91282 54666 110443337
Hypoalbuminaemia 14.69 13.24 3 91293 28971 110469032
Product confusion 14.66 13.24 6 91290 234 110497769
Haematoma 14.61 13.24 16 91280 58460 110439543
Accidental exposure to product 14.46 13.24 12 91284 49996 110448007
Gastroenteritis 14.39 13.24 7 91289 38793 110459210
Full blood count abnormal 14.38 13.24 15 91281 56037 110441966
Blindness 14.36 13.24 6 91290 36353 110461650
Lacrimation increased 14.14 13.24 4 91292 30946 110467057
Diverticulitis 14.10 13.24 14 91282 53508 110444495
Diabetes mellitus 14.05 13.24 39 91257 99342 110398661
Swelling face 13.99 13.24 35 91261 92286 110405717
Insomnia 13.90 13.24 393 90903 360197 110137806
Hypophosphataemia 13.89 13.24 5 91291 33177 110464826
Pseudomonas infection 13.89 13.24 3 91293 27850 110470153
Viral infection 13.88 13.24 14 91282 53125 110444878
Bacteraemia 13.78 13.24 9 91287 42381 110455622
Blood pressure systolic increased 13.75 13.24 30 91266 82961 110415042
Sinus tachycardia 13.72 13.24 10 91286 44483 110453520
Fungal infection 13.72 13.24 13 91283 50793 110447210
Loefgren syndrome 13.62 13.24 5 91291 145 110497858
Bronchitis 13.61 13.24 75 91221 156957 110341046
Rash pruritic 13.48 13.24 39 91257 98030 110399973
Pulmonary arterial hypertension 13.48 13.24 5 91291 32563 110465440
Ulcer haemorrhage 13.31 13.24 45 91251 22526 110475477
Injection site swelling 13.25 13.24 19 91277 61771 110436232

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC G04BD12 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
UROLOGICALS
Drugs for urinary frequency and incontinence
MeSH PA D000318 Adrenergic beta-Agonists
MeSH PA D000322 Adrenergic Agonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018663 Adrenergic Agents
MeSH PA D058667 Adrenergic beta-3 Receptor Agonists
MeSH PA D064804 Urological Agents
FDA MoA N0000182137 Cytochrome P450 2D6 Inhibitors
FDA MoA N0000185007 Adrenergic beta3-Agonists
FDA EPC N0000185008 beta3-Adrenergic Agonist
FDA MoA N0000185503 P-Glycoprotein Inhibitors
FDA MoA N0000190114 Cytochrome P450 3A Inhibitors
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35522 β-adrenergic agonist
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35846 renal agent
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

G04BD Drugs for urinary frequency and incontinence 13 drugs
darifenacinemeproniumfesoterodineflavoxateimidafenacinmeladrazineoxybutyninpropiverinesolifenacinterodilinetolterodinetrospium show all 13 →

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

DiseaseRelationSNOMED_IDDOID
Bladder muscle dysfunction - overactive indication 236633002
Hypertensive disorder contraindication 38341003 DOID:10763




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.32 acidic
pKa2 8.7 Basic
pKa3 4.93 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
25MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 8772315 Oct. 30, 2028 USE IN COMBINATION WITH THE MUSCARINIC ANTAGONIST SOLIFENACIN SUCCINATE FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
50MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 8772315 Oct. 30, 2028 USE IN COMBINATION WITH THE MUSCARINIC ANTAGONIST SOLIFENACIN SUCCINATE FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
25MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 10842780 Sept. 28, 2029 ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS AGED 3 YEARS AND OLDER AND WEIGHING 35 KG OR MORE
25MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 10842780 Sept. 28, 2029 ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
25MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 11707451 Sept. 28, 2029 ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS AGED 3 YEARS AND OLDER AND WEIGHING 35 KG OR MORE
25MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 11707451 Sept. 28, 2029 ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
25MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 12097189 Sept. 28, 2029 ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS AGED 3 YEARS AND OLDER AND WEIGHING 35 KG OR MORE
25MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 12097189 Sept. 28, 2029 ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
50MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 10842780 Sept. 28, 2029 ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS AGED 3 YEARS AND OLDER AND WEIGHING 35 KG OR MORE
50MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 10842780 Sept. 28, 2029 ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
50MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 11707451 Sept. 28, 2029 ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS AGED 3 YEARS AND OLDER AND WEIGHING 35 KG OR MORE
50MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 11707451 Sept. 28, 2029 ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
50MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 12097189 Sept. 28, 2029 ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS AGED 3 YEARS AND OLDER AND WEIGHING 35 KG OR MORE
50MG MYRBETRIQ APGDI N202611 June 28, 2012 RX TABLET, EXTENDED RELEASE ORAL 12097189 Sept. 28, 2029 ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
8MG/ML MYRBETRIQ GRANULES APGDI N213801 March 25, 2021 RX FOR SUSPENSION, EXTENDED RELEASE ORAL 10058536 March 31, 2036 TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS AGED 3 YEARS AND OLDER BY ADMINISTRATION OF AN EXTENDED-RELEASE SUSPENSION FORMULATION OF MIRABEGRON

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Beta-3 adrenergic receptor GPCR AGONIST EC50 7.65 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Beta-2 adrenergic receptor GPCR AGONIST EC50 5.20 IUPHAR
Beta-2 adrenergic receptor GPCR AGONIST EC50 5.20 IUPHAR
Beta-2 adrenergic receptor GPCR AGONIST EC50 5 IUPHAR
Beta-3 adrenergic receptor GPCR AGONIST EC50 9.30 IUPHAR
Beta-3 adrenergic receptor GPCR AGONIST EC50 7.70 IUPHAR

External reference:

IDSource
D09535 KEGG_DRUG
4031804 VANDF
CHEBI:65349 CHEBI
CHEMBL2095212 ChEMBL_ID
C520025 MESH_SUPPLEMENTAL_RECORD_UI
7445 IUPHAR_LIGAND_ID
DB08893 DRUGBANK_ID
MVR3JL3B2V UNII
1300786 RXNORM
191568 MMSL
28616 MMSL
384740 MMSL
d07876 MMSL
014540 NDDF
703803006 SNOMEDCT_US
703804000 SNOMEDCT_US
C2983812 UMLSCUI
H6U PDB_CHEM_ID
8907 INN_ID
9865528 PUBCHEM_CID
MVR3JL3B2V INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 0469-2601 TABLET, FILM COATED, EXTENDED RELEASE 25 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 0469-2602 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 0469-5020 GRANULE, FOR SUSPENSION, EXTENDED RELEASE 8 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 55154-8712 TABLET, FILM COATED, EXTENDED RELEASE 25 mg ORAL NDA 27 sections
Myrbetriq HUMAN PRESCRIPTION DRUG LABEL 1 55154-8713 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 27 sections
Mirabegron HUMAN PRESCRIPTION DRUG LABEL 1 67184-0571 TABLET, FILM COATED, EXTENDED RELEASE 25 mg ORAL ANDA 26 sections
Mirabgeorn HUMAN PRESCRIPTION DRUG LABEL 1 67184-0572 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL ANDA 26 sections
Mirabegron Human Prescription Drug Label 1 67877-890 FOR SUSPENSION, EXTENDED RELEASE 8 mg ORAL ANDA 24 sections
MIRABEGRON HUMAN PRESCRIPTION DRUG LABEL 1 68180-151 TABLET, FILM COATED, EXTENDED RELEASE 25 mg ORAL ANDA 25 sections
MIRABEGRON HUMAN PRESCRIPTION DRUG LABEL 1 68180-152 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL ANDA 25 sections
Mirabegron HUMAN PRESCRIPTION DRUG LABEL 1 69238-2860 TABLET, FILM COATED, EXTENDED RELEASE 25 mg ORAL ANDA 28 sections
Mirabegron HUMAN PRESCRIPTION DRUG LABEL 1 69238-2861 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL ANDA 28 sections
Mirabegron HUMAN PRESCRIPTION DRUG LABEL 1 70518-4304 TABLET, EXTENDED RELEASE 50 mg ORAL ANDA 23 sections
Mirabegron HUMAN PRESCRIPTION DRUG LABEL 1 70518-4631 TABLET, EXTENDED RELEASE 25 mg ORAL ANDA 23 sections
MIRABEGRON HUMAN PRESCRIPTION DRUG LABEL 1 70518-4665 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL ANDA 25 sections
Mirabegron HUMAN PRESCRIPTION DRUG LABEL 1 70710-1159 TABLET, EXTENDED RELEASE 25 mg ORAL ANDA 23 sections
Mirabegron HUMAN PRESCRIPTION DRUG LABEL 1 70710-1160 TABLET, EXTENDED RELEASE 50 mg ORAL ANDA 23 sections
Mirabegron HUMAN PRESCRIPTION DRUG LABEL 1 70771-1752 TABLET, EXTENDED RELEASE 25 mg ORAL ANDA 25 sections
Mirabegron HUMAN PRESCRIPTION DRUG LABEL 1 70771-1753 TABLET, EXTENDED RELEASE 50 mg ORAL ANDA 25 sections
MIRABEGRON HUMAN PRESCRIPTION DRUG LABEL 1 71335-2807 TABLET, FILM COATED, EXTENDED RELEASE 25 mg ORAL ANDA 25 sections
MIRABEGRON HUMAN PRESCRIPTION DRUG LABEL 1 71335-2808 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL ANDA 25 sections
MIRABEGRON HUMAN PRESCRIPTION DRUG LABEL 1 71335-2809 TABLET, FILM COATED, EXTENDED RELEASE 25 mg ORAL ANDA 25 sections
MIRABEGRON HUMAN PRESCRIPTION DRUG LABEL 1 71335-2810 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL ANDA 25 sections