botulinum toxin type A 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
5368 None

Description:

MoleculeDescription

Synonyms:

  • botulinum toxin type A
  • nuceiva
  • incobotulinumtoxin A
  • NT 201
Botulinum toxin type A (Clostridium botulinum neurotoxin) blocks peripheral acetylcholine release at presynaptic cholinergic nerve terminals by cleaving SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within the nerve endings, thereby leading to denervation of the muscle and a flaccid paralysis.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Dec. 20, 2019 PMDA GlaxoSmithKline K.K.
Sept. 27, 2019 EMA Evolus Pharma Limited

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
Drug ineffective 17685.97 17.37 16505 148128 1367793 89096021
Product preparation error 9588.07 17.37 2460 162173 7801 90456013
Therapeutic response decreased 5732.84 17.37 2934 161699 86795 90377019
Multiple use of single-use product 5503.00 17.37 1136 163497 687 90463127
Eyelid ptosis 5486.82 17.37 1541 163092 7465 90456349
Off label use 4511.63 17.37 7508 157125 1094744 89369070
Wrong technique in product usage process 3739.53 17.37 2048 162585 69523 90394291
Injection site pain 2284.20 17.37 2141 162492 171558 90292256
Facial paresis 1497.70 17.37 469 164164 3494 90460320
Product preparation issue 1444.21 17.37 405 164228 1941 90461873
Brow ptosis 1293.11 17.37 261 164372 113 90463701
Botulism 1016.43 17.37 207 164426 103 90463711
Injection site swelling 963.45 17.37 828 163805 59011 90404803
Poor quality product administered 913.33 17.37 324 164309 3684 90460130
Swelling face 821.67 17.37 870 163763 80482 90383332
Drug ineffective for unapproved indication 741.91 17.37 751 163882 65893 90397921
Therapeutic response shortened 716.99 17.37 472 164161 22407 90441407
Blepharospasm 688.06 17.37 663 163970 54782 90409032
Dysphagia 671.45 17.37 920 163713 111358 90352456
Muscular weakness 628.90 17.37 1248 163385 205418 90258396
Product quality issue 620.85 17.37 743 163890 78582 90385232
Product storage error 572.86 17.37 392 164241 19849 90443965
Eye swelling 533.50 17.37 436 164197 28950 90434864
Neuromuscular toxicity 527.53 17.37 120 164513 181 90463633
Neck pain 511.37 17.37 816 163817 113147 90350667
Anaemia 496.64 17.37 38 164595 352764 90111050
Acute kidney injury 482.43 17.37 24 164609 320363 90143451
Facial asymmetry 478.69 17.37 140 164493 800 90463014
Epilepsy 462.02 17.37 654 163979 81552 90382262
Taste disorder 446.64 17.37 555 164078 60991 90402823
Eyelid oedema 428.57 17.37 265 164368 11269 90452545
Facial paralysis 404.80 17.37 286 164347 15248 90448566
Vision blurred 395.78 17.37 715 163918 109578 90354236
Migraine 375.30 17.37 968 163665 189424 90274390
Neutropenia 373.58 17.37 7 164626 224897 90238917
Diarrhoea 345.81 17.37 746 163887 938444 89525370
Diplopia 336.72 17.37 333 164300 28381 90435433
Thrombocytopenia 333.22 17.37 10 164623 208715 90255099
Pyrexia 315.19 17.37 445 164188 660040 89803774
Onychomadesis 311.80 17.37 401 164232 45597 90418217
Toxicity to various agents 308.76 17.37 72 164561 287774 90176040
Nail disorder 304.22 17.37 451 164182 58616 90405198
Breast cancer stage III 303.59 17.37 548 164085 83899 90379915
Back injury 299.77 17.37 396 164237 46226 90417588
Periorbital swelling 297.04 17.37 154 164479 4644 90459170
Hypoaesthesia 293.43 17.37 1239 163394 312971 90150843
Drug interaction 292.86 17.37 71 164562 276382 90187432
Hypotension 272.56 17.37 125 164508 325272 90138542
Febrile neutropenia 266.80 17.37 4 164629 158345 90305469
Infection 249.13 17.37 177 164456 361917 90101897
Injection site rash 235.85 17.37 254 164379 23919 90439895
Completed suicide 235.02 17.37 6 164627 145052 90318762
Headache 227.98 17.37 2480 162153 860266 89603548
Skin tightness 227.17 17.37 126 164507 4362 90459452
Dysphonia 226.23 17.37 409 164224 62675 90401139
Sepsis 225.28 17.37 30 164603 179784 90284030
Paraesthesia 224.22 17.37 975 163658 249351 90214463
Disease progression 219.82 17.37 17 164616 156598 90307216
Incorrect route of product administration 218.03 17.37 356 164277 50270 90413544
Oedema peripheral 212.95 17.37 101 164532 257814 90206000
Haemoglobin decreased 212.81 17.37 23 164610 161933 90301881
Injection site mass 206.60 17.37 227 164406 21863 90441951
Gastrooesophageal reflux disease 206.12 17.37 718 163915 165619 90298195
Cough 205.78 17.37 220 164413 368742 90095072
Product label confusion 202 17.37 228 164405 22622 90441192
Onychomycosis 200.55 17.37 291 164342 37085 90426729
Injection site erythema 200.30 17.37 507 164126 97995 90365819
Facet joint syndrome 199.63 17.37 506 164127 97883 90365931
Product dose omission issue 198.72 17.37 144 164489 291543 90172271
Pancytopenia 198.61 17.37 4 164629 120259 90343555
Influenza like illness 195.21 17.37 444 164189 80167 90383647
Facial pain 195.10 17.37 174 164459 13008 90450806
Platelet count decreased 194.69 17.37 14 164619 136955 90326859
Hyponatraemia 191.70 17.37 13 164620 133525 90330289
Back pain 188.40 17.37 179 164454 316996 90146818
Adverse reaction 185.80 17.37 249 164384 29463 90434351
Peripheral venous disease 184.41 17.37 445 164188 83476 90380338
Renal failure 181.67 17.37 15 164618 130992 90332822
Fatigue 181.01 17.37 1292 163341 1152731 89311083
Arthralgia 179.23 17.37 767 163866 777755 89686059
Drug effect less than expected 176.31 17.37 120 164513 6018 90457796
Sinusitis 171.54 17.37 223 164410 342865 90120949
Pneumonia 170.99 17.37 591 164042 637468 89826346
Injection site nodule 169.29 17.37 104 164529 4369 90459445
Eyelid sensory disorder 168.71 17.37 40 164593 80 90463734
White blood cell count decreased 167.23 17.37 48 164585 167061 90296753
Lagophthalmos 166.44 17.37 53 164580 419 90463395
Renal impairment 164.83 17.37 6 164627 105415 90358399
Finger deformity 164.80 17.37 248 164385 32649 90431165
Bursitis 163.67 17.37 569 164064 131085 90332729
Live birth 162.72 17.37 409 164224 78698 90385116
Constipation 162.15 17.37 162 164471 280233 90183581
Blood creatinine increased 157.73 17.37 6 164627 101380 90362434
Dehydration 157.65 17.37 78 164555 194369 90269445
Pleural effusion 157.59 17.37 12 164621 111979 90351835
Alanine aminotransferase increased 157.52 17.37 16 164617 118322 90345492
Neuropathy peripheral 149.29 17.37 33 164600 136937 90326877
Wound infection 149.24 17.37 479 164154 105923 90357891
Cardiac failure 147.86 17.37 14 164619 109482 90354332
Aspartate aminotransferase increased 147.80 17.37 10 164623 102927 90360887
Swelling of eyelid 145.76 17.37 102 164531 5352 90458462
Product administered at inappropriate site 145.70 17.37 92 164541 4059 90459755
Intentional overdose 144.46 17.37 6 164627 93828 90369986
Urinary tract infection 144.34 17.37 207 164426 305425 90158389
Facial discomfort 144.33 17.37 44 164589 296 90463518
Hypokalaemia 144.10 17.37 31 164602 131085 90332729
Hypercholesterolaemia 144.06 17.37 457 164176 100435 90363379
Atrial fibrillation 142.02 17.37 34 164599 133577 90330237
Gastrointestinal haemorrhage 141.57 17.37 5 164628 90243 90373571
Abdominal pain 141.17 17.37 319 164314 395402 90068412
Dry mouth 141.02 17.37 685 163948 183374 90280440
Coeliac disease 140.94 17.37 274 164359 44336 90419478
Infusion site reaction 138.54 17.37 172 164461 18867 90444947
Pulmonary embolism 135.73 17.37 35 164598 130785 90333029
Cardiac failure congestive 132.26 17.37 13 164620 98681 90365133
Lip dry 129.54 17.37 441 164192 100514 90363300
Drug abuse 124.36 17.37 6 164627 82341 90381473
Asthenopia 118.64 17.37 71 164562 2843 90460971
Injection site reaction 117.93 17.37 402 164231 91678 90372136
Decreased appetite 117.56 17.37 325 164308 376215 90087599
Cardiac arrest 116.97 17.37 24 164609 104911 90358903
Injection site oedema 116.11 17.37 59 164574 1704 90462110
Bronchitis 115.65 17.37 67 164566 152860 90310954
Arthritis 114.66 17.37 82 164551 167233 90296581
Nausea 114.49 17.37 1380 163253 1108936 89354878
Leukopenia 114.43 17.37 22 164611 100688 90363126
Obesity 114.20 17.37 436 164197 105071 90358743
Fall 113.51 17.37 470 164163 481340 89982474
Sleep disorder due to general medical condition, insomnia type 111.49 17.37 47 164586 128647 90335167
Respiratory failure 111.33 17.37 38 164595 118380 90345434
Deep vein thrombosis 110.72 17.37 17 164616 91603 90372211
Suicide attempt 109.20 17.37 7 164626 75392 90388422
Hypoxia 107.04 17.37 6 164627 72393 90391421
Muscle twitching 106.64 17.37 172 164461 24030 90439784
Neutrophil count decreased 105.54 17.37 6 164627 71526 90392288
Septic shock 105.47 17.37 14 164619 84146 90379668
Injection site papule 105.25 17.37 45 164588 867 90462947
Myocardial infarction 103.16 17.37 32 164601 105940 90357874
Injection site paraesthesia 102.68 17.37 41 164592 659 90463155
Oxygen saturation decreased 101.90 17.37 34 164599 107449 90356365
Vomiting 101.78 17.37 929 163704 787364 89676450
Blood glucose increased 101.68 17.37 24 164609 95222 90368592
Periorbital oedema 101.12 17.37 90 164543 6709 90457105
Rheumatoid factor positive 100.52 17.37 98 164535 171552 90292262
Blood pressure increased 99.71 17.37 127 164506 197090 90266724
Chest pain 99.66 17.37 276 164357 319369 90144445
Injection site urticaria 97.73 17.37 141 164492 17870 90445944
Muscle tightness 97.12 17.37 121 164512 13318 90450496
Swollen tongue 97.00 17.37 240 164393 45716 90418098
Coma 96.19 17.37 10 164623 72622 90391192
Haematochezia 95.91 17.37 9 164624 70904 90392910
Muscle spasms 95.53 17.37 783 163850 251100 90212714
Joint swelling 94.65 17.37 532 164101 502768 89961046
Hypoglycaemia 94.11 17.37 9 164624 69839 90393975
Chronic obstructive pulmonary disease 93.20 17.37 12 164621 73817 90389997
Injection site discomfort 93.08 17.37 81 164552 5859 90457955
Weight decreased 92.96 17.37 365 164268 379545 90084269
Multiple organ dysfunction syndrome 91.56 17.37 9 164624 68327 90395487
Facial spasm 91.52 17.37 39 164594 745 90463069
Skin indentation 91.41 17.37 21 164612 34 90463780
Mucosal inflammation 91.05 17.37 3 164630 57622 90406192
Injection site granuloma 90.93 17.37 23 164610 67 90463747
Inflammation 89.91 17.37 594 164039 177998 90285816
Head discomfort 88.82 17.37 128 164505 16205 90447609
Bradycardia 87.80 17.37 22 164611 83825 90379989
Urticaria 87.20 17.37 910 163723 311824 90151990
Colitis 86.78 17.37 12 164621 69930 90393884
Neovascularisation 85.90 17.37 47 164586 1583 90462231
Overdose 85.82 17.37 535 164098 157174 90306640
Pruritus 85.55 17.37 604 164029 540921 89922893
Hypoaesthesia oral 84.46 17.37 122 164511 15478 90448336
Metabolic acidosis 84.25 17.37 4 164629 55672 90408142
Pulmonary oedema 81.05 17.37 9 164624 62071 90401743
Injection site indentation 80.82 17.37 28 164605 295 90463519
Product temperature excursion issue 79.94 17.37 37 164596 866 90462948
Hyperglycaemia 79.33 17.37 3 164630 50967 90412847
Liver function test increased 77.74 17.37 333 164300 84522 90379292
Injection site hypoaesthesia 77.36 17.37 33 164600 632 90463182
Blood pressure systolic increased 77.35 17.37 8 164625 58337 90405477
Cataract 77.28 17.37 18 164615 72074 90391740
Epistaxis 77.14 17.37 29 164604 85096 90378718
C-reactive protein increased 77.08 17.37 579 164054 180810 90283004
Grip strength decreased 76.28 17.37 352 164281 92224 90371590
Oedema 75.87 17.37 156 164477 200139 90263675
Liver function test abnormal 75.83 17.37 4 164629 50841 90412973
Product distribution issue 73.66 17.37 58 164575 3647 90460167
Cardio-respiratory arrest 73.42 17.37 13 164620 63127 90400687
Lid sulcus deepened 72.14 17.37 20 164613 91 90463723
Pain 72.10 17.37 1326 163307 995015 89468799
Fluid retention 71.87 17.37 35 164598 88056 90375758
Psoriasis 71.76 17.37 98 164535 147656 90316158
Mastication disorder 70.50 17.37 48 164585 2408 90461406
Hepatotoxicity 70.32 17.37 3 164630 45839 90417975
Dyspnoea 70.27 17.37 1152 163481 879803 89584011
Burning sensation 70.11 17.37 264 164369 63188 90400626
Lacrimation increased 69.90 17.37 153 164480 26909 90436905
Pain in extremity 69.90 17.37 505 164128 450024 90013790
International normalised ratio increased 69.70 17.37 4 164629 47312 90416502
Mephisto sign 69.07 17.37 13 164620 0 90463814
Memory impairment 68.33 17.37 601 164032 196643 90267171
Influenza 68.00 17.37 92 164541 139172 90324642
Diabetes mellitus 67.97 17.37 17 164616 64858 90398956
Agitation 67.61 17.37 19 164614 67079 90396735
Pneumonitis 67.40 17.37 3 164630 44167 90419647
Speech disorder 67.35 17.37 209 164424 45376 90418438
Ophthalmoplegia 67.04 17.37 41 164592 1708 90462106
Injection site pruritus 66.27 17.37 232 164401 53602 90410212
Gait inability 65.93 17.37 474 164159 145982 90317832
Tachycardia 65.66 17.37 116 164517 157557 90306257
Somnolence 64.78 17.37 181 164452 208903 90254911
Night sweats 64.61 17.37 428 164205 128338 90335476
Liver disorder 64.55 17.37 75 164558 121194 90342620
Paralysis 63.95 17.37 91 164542 11387 90452427
Patient dissatisfaction with treatment 63.78 17.37 24 164609 326 90463488
Overlap syndrome 63.44 17.37 78 164555 8470 90455344
Joint range of motion decreased 63.38 17.37 443 164190 135200 90328614
Dyspnoea exertional 63.24 17.37 26 164607 72262 90391552
Eye pain 62.95 17.37 200 164433 43968 90419846
Red blood cell count decreased 62.37 17.37 6 164627 46345 90417469
Plasma cell myeloma 61.56 17.37 3 164630 40825 90422989
Injection site bruising 61.46 17.37 222 164411 52085 90411729
Thrombosis 61.46 17.37 28 164605 73223 90390591
Blood alkaline phosphatase increased 60.24 17.37 8 164625 48071 90415743
COVID-19 60.20 17.37 136 164497 168707 90295107
Blood bilirubin increased 60.19 17.37 5 164628 43465 90420349
Encephalopathy 59.96 17.37 7 164626 46437 90417377
Skin wrinkling 58.81 17.37 35 164598 1387 90462427
Rhabdomyolysis 58.64 17.37 11 164622 51245 90412569
Asthma 58.32 17.37 234 164399 241926 90221888
Therapeutic product effect incomplete 58.20 17.37 573 164060 193323 90270491
Productive cough 57.91 17.37 34 164599 77029 90386785
Lip disorder 57.05 17.37 36 164597 1586 90462228
Knee arthroplasty 56.66 17.37 41 164592 83141 90380673
Upper respiratory tract infection 56.57 17.37 91 164542 128227 90335587
Drug reaction with eosinophilia and systemic symptoms 56.32 17.37 6 164627 42752 90421062
Death 56.20 17.37 544 164089 456007 90007807
Rash maculo-papular 55.88 17.37 5 164628 40928 90422886
Hypocalcaemia 55.67 17.37 6 164627 42362 90421452
Transaminases increased 55.23 17.37 3 164630 37189 90426625
Type 2 diabetes mellitus 54.99 17.37 588 164045 202656 90261158
Electrocardiogram QT prolonged 54.40 17.37 32 164601 72424 90391390
Product packaging issue 54.19 17.37 35 164598 1606 90462208
Injection site inflammation 53.85 17.37 53 164580 4488 90459326
Clostridium difficile infection 53.59 17.37 3 164630 36242 90427572
Femur fracture 52.48 17.37 10 164623 46072 90417742
Mental status changes 52.39 17.37 9 164624 44670 90419144
Haematocrit decreased 52.31 17.37 7 164626 41825 90421989
Blood pressure decreased 52.22 17.37 36 164597 74859 90388955
Hepatic steatosis 51.85 17.37 4 164629 36941 90426873
Malaise 51.46 17.37 752 163881 585234 89878580
Foot deformity 51.31 17.37 22 164611 59629 90404185
Hallucination 51.14 17.37 28 164605 65931 90397883
Melaena 51.08 17.37 3 164630 34794 90429020
Macular degeneration 50.87 17.37 5 164628 37965 90425849
Gamma-glutamyltransferase increased 50.84 17.37 5 164628 37947 90425867
Skin ulcer 50.78 17.37 14 164619 50061 90413753
Hepatic enzyme 50.11 17.37 55 164578 5289 90458525
Premature delivery 49.65 17.37 6 164627 38756 90425058
Drug hypersensitivity 49.51 17.37 571 164062 463038 90000776
Vascular malformation 49.04 17.37 25 164608 727 90463087
Pericardial effusion 48.95 17.37 5 164628 36828 90426986
Product reconstitution quality issue 48.94 17.37 15 164618 103 90463711
Hepatic failure 48.85 17.37 7 164626 39721 90424093
Syncope 48.81 17.37 105 164528 132558 90331256
Suspected product quality issue 48.81 17.37 21 164612 411 90463403
Rectal haemorrhage 48.70 17.37 47 164586 82697 90381117
Full blood count abnormal 48.56 17.37 5 164628 36592 90427222
Drug-induced liver injury 48.24 17.37 305 164328 90013 90373801
Pancreatitis 48.11 17.37 34 164599 69792 90394022
Photophobia 48.00 17.37 114 164519 21155 90442659
Gait disturbance 47.99 17.37 277 164356 260219 90203595
Condition aggravated 47.96 17.37 777 163856 594768 89869046
Angioedema 47.88 17.37 239 164394 64637 90399177
Hepatitis 47.62 17.37 254 164379 70485 90393329
Hip arthroplasty 47.58 17.37 41 164592 76167 90387647
Blood pressure fluctuation 47.25 17.37 18 164615 52395 90411419
Flatulence 47.06 17.37 9 164624 41358 90422456
Diverticulitis 47.03 17.37 12 164621 45175 90418639
Abdominal discomfort 46.75 17.37 599 164034 476729 89987085
Lung disorder 46.47 17.37 446 164187 149437 90314377
Haemorrhage 46.20 17.37 35 164598 69334 90394480
Cellulitis 45.95 17.37 59 164574 91278 90372536
Haemoptysis 45.67 17.37 4 164629 33316 90430498
Eyelid pain 45.24 17.37 24 164609 759 90463055
Libido increased 45.17 17.37 32 164601 1712 90462102
Delirium 45.07 17.37 75 164558 104284 90359530
Post-traumatic neck syndrome 44.98 17.37 37 164596 2477 90461337
Dry eye 44.59 17.37 216 164417 57715 90406099
Paranasal cyst 44.48 17.37 24 164609 786 90463028
Cholelithiasis 44.16 17.37 20 164613 52486 90411328
Ocular discomfort 43.88 17.37 56 164577 6314 90457500
Pancreatitis acute 43.63 17.37 4 164629 32111 90431703
Blood urea increased 43.52 17.37 3 164630 30410 90433404
Psoriatic arthropathy 42.93 17.37 617 164016 227718 90236096
Intestinal obstruction 42.41 17.37 8 164625 37123 90426691
Ulcer 42.34 17.37 5 164628 32877 90430937
Dry skin 42.17 17.37 59 164574 88014 90375800
Soft tissue injury 42.13 17.37 33 164600 2059 90461755
Colitis ulcerative 41.97 17.37 29 164604 60237 90403577
Oral candidiasis 41.88 17.37 7 164626 35448 90428366
Jaundice 41.73 17.37 5 164628 32512 90431302
Endometriosis 41.58 17.37 54 164579 6194 90457620
Musculoskeletal pain 41.56 17.37 485 164148 170766 90293048
Throat tightness 41.55 17.37 133 164500 29351 90434463
Strabismus 41.41 17.37 35 164598 2433 90461381
Disease recurrence 41.16 17.37 9 164624 37644 90426170
Osteoporosis 41.11 17.37 70 164563 96461 90367353
Dizziness 41.01 17.37 1379 163254 587905 89875909
White blood cell count increased 40.98 17.37 37 164596 67204 90396610
Pharyngeal hypoaesthesia 40.81 17.37 18 164615 375 90463439
Folliculitis 40.75 17.37 558 164075 203795 90260019
Eyelid disorder 40.63 17.37 33 164600 2170 90461644
Cervicogenic headache 40.32 17.37 15 164618 197 90463617
Orthostatic hypotension 40.04 17.37 13 164620 41814 90422000
Device dislocation 40.01 17.37 5 164628 31477 90432337
Hostility 39.72 17.37 33 164600 2240 90461574
Intentional product use issue 39.55 17.37 583 164050 216309 90247505
Abnormal sensation in eye 39.50 17.37 31 164602 1940 90461874
Rash 39.21 17.37 1124 163509 794976 89668838
Sciatica 39.19 17.37 78 164555 101304 90362510
Injection site hypersensitivity 38.83 17.37 35 164598 2652 90461162
Depressed level of consciousness 38.74 17.37 45 164588 72739 90391075
Rash pruritic 38.44 17.37 56 164577 82158 90381656
Acute respiratory failure 38.25 17.37 15 164618 42903 90420911
Pulmonary mass 37.99 17.37 4 164629 28768 90435046
Hypoaesthesia eye 37.95 17.37 18 164615 446 90463368
Bone pain 37.90 17.37 34 164599 61949 90401865
Product prescribing error 37.80 17.37 5 164628 30140 90433674
Eosinophilia 37.59 17.37 4 164629 28529 90435285
Sinus tachycardia 37.56 17.37 4 164629 28509 90435305
Blood potassium decreased 37.38 17.37 20 164613 47707 90416107
Manufacturing product shipping issue 37.34 17.37 12 164621 98 90463716
Mouth ulceration 37.26 17.37 13 164620 39961 90423853
Clostridium difficile colitis 37.17 17.37 3 164630 26703 90437111
Haematemesis 36.99 17.37 8 164625 33718 90430096
Swollen joint count increased 36.91 17.37 93 164540 111113 90352701
Leukocytosis 36.87 17.37 6 164627 30984 90432830
Acute myocardial infarction 36.82 17.37 9 164624 34881 90428933
Pineal gland cyst 36.82 17.37 14 164619 196 90463618
Hepatic cytolysis 36.75 17.37 6 164627 30910 90432904
Dermatochalasis 36.72 17.37 9 164624 22 90463792
Injection site pallor 36.60 17.37 11 164622 70 90463744
Erythema of eyelid 36.50 17.37 37 164596 3246 90460568
Drug dependence 36.45 17.37 5 164628 29322 90434492
Peripheral swelling 36.26 17.37 530 164103 412576 90051238
Cerebral haemorrhage 36.25 17.37 9 164624 34513 90429301
Muscle atrophy 36.05 17.37 59 164574 8342 90455472
Renal disorder 35.83 17.37 12 164621 37847 90425967
Incorrect dose administered 35.82 17.37 256 164377 78674 90385140
Cognitive disorder 35.78 17.37 44 164589 69363 90394451
Heart rate decreased 35.63 17.37 27 164606 53478 90410336
Altered state of consciousness 35.57 17.37 7 164626 31525 90432289
Blood calcium decreased 35.56 17.37 6 164627 30176 90433638
Shock 35.55 17.37 5 164628 28773 90435041
Candida infection 35.53 17.37 9 164624 34048 90429766
Tension headache 35.33 17.37 55 164578 7454 90456360
Joint injury 35.31 17.37 8 164625 32656 90431158
Cerebrovascular accident 35.31 17.37 111 164522 123422 90340392
Central nervous system function test abnormal 35.14 17.37 9 164624 28 90463786
Therapeutic product effect decreased 34.98 17.37 703 163930 276868 90186946
Eyelid function disorder 34.94 17.37 15 164618 292 90463522
Injection site haemorrhage 34.81 17.37 122 164511 28196 90435618
Eczema 34.80 17.37 27 164606 52843 90410971
Localised infection 34.76 17.37 9 164624 33553 90430261
Treatment noncompliance 34.57 17.37 26 164607 51701 90412113
Choking 34.51 17.37 71 164562 11962 90451852
Basal cell carcinoma 34.49 17.37 9 164624 33380 90430434
Restlessness 34.37 17.37 11 164622 35709 90428105
Cerebral infarction 34.35 17.37 4 164629 26592 90437222
Fibromyalgia 34.35 17.37 546 164087 205723 90258091
Paradoxical drug reaction 34.04 17.37 47 164586 5719 90458095
Madarosis 33.42 17.37 37 164596 3592 90460222
Heart rate increased 33.30 17.37 100 164533 112802 90351012
Lung neoplasm malignant 33.04 17.37 3 164630 24270 90439544
Sternal fracture 32.95 17.37 33 164600 2854 90460960
Mastoiditis 32.89 17.37 26 164607 1644 90462170
Unresponsive to stimuli 32.88 17.37 14 164619 38107 90425707
Arrhythmia 32.77 17.37 18 164615 42314 90421500
Chills 32.73 17.37 126 164507 131855 90331959
Nerve injury 32.41 17.37 66 164567 11040 90452774
Blood pressure diastolic decreased 32.35 17.37 5 164628 26821 90436993
Body temperature decreased 32.26 17.37 3 164630 23813 90440001
Chronic sinusitis 32.24 17.37 3 164630 23799 90440015
Stevens-Johnson syndrome 32.15 17.37 7 164626 29369 90434445
Intranasal hypoaesthesia 31.88 17.37 6 164627 0 90463814
Staphylococcal infection 31.55 17.37 25 164608 48414 90415400
Hypothyroidism 31.47 17.37 30 164603 53097 90410717
Blood sodium decreased 31.43 17.37 6 164627 27607 90436207
Respiratory tract infection 30.93 17.37 37 164596 59041 90404773
Osteopenia 30.89 17.37 3 164630 22999 90440815
Gastric disorder 30.87 17.37 11 164622 33373 90430441
Rhinorrhoea 30.77 17.37 72 164561 88244 90375570
Muscle contractions involuntary 30.74 17.37 32 164601 2896 90460918
Product use in unapproved indication 30.13 17.37 812 163821 335424 90128390
Illness 30.05 17.37 65 164568 81904 90381910
Herpes zoster 29.99 17.37 81 164552 94563 90369251
Hypophagia 29.74 17.37 14 164619 35923 90427891
Vaginal haemorrhage 29.44 17.37 10 164623 31261 90432553
Tooth disorder 29.17 17.37 10 164623 31080 90432734
Acute respiratory distress syndrome 29.13 17.37 8 164625 28678 90435136
Fungal infection 29.09 17.37 21 164612 42640 90421174
Eye discharge 28.90 17.37 53 164580 8205 90455609
Injection site anaesthesia 28.75 17.37 8 164625 37 90463777
Bone disorder 28.60 17.37 4 164629 23116 90440698
Hallucination, visual 28.55 17.37 4 164629 23088 90440726
Ear infection 28.44 17.37 52 164581 69723 90394091
Atelectasis 28.43 17.37 5 164628 24404 90439410
Product administered by wrong person 28.39 17.37 9 164624 70 90463744
Lip swelling 28.32 17.37 142 164491 38468 90425346
Gastroenteritis 28.13 17.37 9 164624 29220 90434594
Cutis laxa 28.00 17.37 11 164622 169 90463645
Blood cholesterol increased 27.94 17.37 532 164101 207480 90256334
Small intestinal obstruction 27.92 17.37 3 164630 21231 90442583
Gastritis 27.89 17.37 21 164612 41732 90422082
Abdominal pain lower 27.81 17.37 10 164623 30167 90433647
Application site acne 27.73 17.37 6 164627 6 90463808
Psychotic disorder 27.69 17.37 11 164622 31219 90432595
Mitral valve incompetence 27.62 17.37 4 164629 22520 90441294
Procedural pain 27.60 17.37 13 164620 33347 90430467
Dementia 27.55 17.37 5 164628 23856 90439958
Blood test abnormal 27.44 17.37 3 164630 20949 90442865
Nasopharyngitis 27.39 17.37 548 164085 406556 90057258
Drug withdrawal syndrome 27.37 17.37 9 164624 28714 90435100
Bacteraemia 27.25 17.37 4 164629 22296 90441518
Gastric ulcer 27.23 17.37 8 164625 27440 90436374
Blood potassium increased 27.10 17.37 3 164630 20746 90443068
Incorrect product administration duration 27.08 17.37 87 164546 19235 90444579
Eyelid thickening 27.04 17.37 9 164624 83 90463731
Food allergy 26.07 17.37 7 164626 25471 90438343
Osteomyelitis 26.05 17.37 9 164624 27837 90435977
Nasal congestion 25.97 17.37 72 164561 83342 90380472
Muscle hypertrophy 25.96 17.37 9 164624 95 90463719
Hypocholesterolaemia 25.94 17.37 44 164589 6405 90457409
Angina pectoris 25.77 17.37 20 164613 39140 90424674
Blood pressure diastolic abnormal 25.65 17.37 3 164630 19878 90443936
Normal newborn 25.63 17.37 97 164536 23265 90440549
Skin exfoliation 25.61 17.37 53 164580 67860 90395954
Muscle injury 25.53 17.37 457 164176 176197 90287617
Myasthenic syndrome 25.47 17.37 13 164620 379 90463435
Acute hepatic failure 25.47 17.37 5 164628 22556 90441258
Hot flush 25.45 17.37 43 164590 59445 90404369
Haematuria 25.43 17.37 16 164617 34921 90428893
Vertigo 25.34 17.37 215 164418 69596 90394218
Torticollis 25.16 17.37 27 164606 2531 90461283
Oral pain 25.15 17.37 14 164619 32669 90431145
Weight increased 24.79 17.37 574 164059 417353 90046461
Osteoarthritis 24.73 17.37 496 164137 195234 90268580
Diaphragmatic rupture 24.60 17.37 11 164622 237 90463577
Therapy interrupted 24.55 17.37 33 164600 50075 90413739
Vestibular migraine 24.43 17.37 11 164622 241 90463573
Lymphocyte count decreased 24.23 17.37 17 164616 35033 90428781
Blepharochalasis 24.22 17.37 5 164628 3 90463811
Injection site deformation 24.22 17.37 5 164628 3 90463811
Red blood cell sedimentation rate abnormal 24.11 17.37 7 164626 24197 90439617
Loss of personal independence in daily activities 23.84 17.37 147 164486 135958 90327856
Cardiomyopathy 23.84 17.37 4 164629 20202 90443612
Ejection fraction decreased 23.69 17.37 9 164624 26244 90437570
Occupational exposure to product 23.65 17.37 26 164607 2505 90461309
Injection site infection 23.62 17.37 25 164608 2307 90461507
Foetal exposure during pregnancy 23.49 17.37 26 164607 42949 90420865
Anti-cyclic citrullinated peptide antibody 23.47 17.37 10 164623 27211 90436603
Therapy non-responder 23.25 17.37 149 164484 136555 90327259
Peritonitis 23.03 17.37 4 164629 19701 90444113
Eye contusion 22.94 17.37 26 164607 2590 90461224
Medication error 22.85 17.37 78 164555 84574 90379240
Cystitis 22.76 17.37 55 164578 66663 90397151
Immunodeficiency 22.72 17.37 27 164606 43207 90420607
Product quality control issue 22.67 17.37 6 164627 22 90463792
Aggression 22.67 17.37 10 164623 26658 90437156
Vaginal discharge 22.64 17.37 4 164629 19460 90444354
Product substitution issue 22.55 17.37 3 164630 18005 90445809
Bronchospasm 22.53 17.37 5 164628 20704 90443110
Neutrophil count increased 22.53 17.37 4 164629 19386 90444428
Blood iron decreased 22.47 17.37 3 164630 17956 90445858
Female genital tract fistula 22.32 17.37 3 164630 17865 90445949
Loss of consciousness 22.27 17.37 156 164477 140082 90323732
Road traffic accident 22.27 17.37 110 164523 107516 90356298
Flank pain 22.25 17.37 4 164629 19218 90444596
Product dose omission in error 22.21 17.37 5 164628 20498 90443316
Hypertensive crisis 22.18 17.37 3 164630 17781 90446033
Drug eruption 22.16 17.37 19 164614 35388 90428426
Suicidal ideation 22.07 17.37 65 164568 73790 90390024
Sputum discoloured 22.03 17.37 5 164628 20386 90443428
Ankle fracture 22.00 17.37 5 164628 20365 90443449
Eye movement disorder 21.97 17.37 40 164593 6158 90457656
Upper limb fracture 21.94 17.37 6 164627 21572 90442242
Frequent bowel movements 21.83 17.37 44 164589 56891 90406923
Vasculitis 21.82 17.37 7 164626 22686 90441128
Cardiomegaly 21.78 17.37 4 164629 18921 90444893
Circulatory collapse 21.71 17.37 9 164624 24895 90438919
Drug tolerance decreased 21.67 17.37 16 164617 32114 90431700
Lethargy 21.57 17.37 52 164581 63087 90400727
Urosepsis 21.41 17.37 6 164627 21226 90442588
Injection site haematoma 21.23 17.37 42 164591 6880 90456934
Duodenal ulcer perforation 21.13 17.37 539 164094 220749 90243065
Radiculopathy 21.10 17.37 4 164629 18501 90445313
Face lift 21.09 17.37 5 164628 10 90463804
Limb injury 20.85 17.37 16 164617 31492 90432322
Platelet count increased 20.84 17.37 6 164627 20853 90442961
Mass 20.81 17.37 69 164564 15508 90448306
Rhinitis allergic 20.54 17.37 3 164630 16782 90447032
Pulmonary fibrosis 20.49 17.37 113 164520 107390 90356424
Alopecia 20.44 17.37 715 163918 494356 89969458
Drug specific antibody 20.41 17.37 24 164609 2488 90461326
Hip fracture 20.40 17.37 18 164615 33059 90430755
Application site papules 20.36 17.37 7 164626 72 90463742
Subdural haematoma 20.31 17.37 3 164630 16642 90447172
Liver injury 20.15 17.37 428 164205 170139 90293675
Skin laxity 20.10 17.37 7 164626 75 90463739
Hospitalisation 20.10 17.37 143 164490 127957 90335857
Congenital anomaly 20.06 17.37 39 164594 6308 90457506
Obstructive airways disorder 20.02 17.37 11 164622 25858 90437956
Injection site discolouration 20.01 17.37 49 164584 9271 90454543
Migraine without aura 19.90 17.37 14 164619 741 90463073
Calcification of muscle 19.87 17.37 9 164624 200 90463614
Haematoma 19.87 17.37 25 164608 39023 90424791
Vitreous floaters 19.86 17.37 43 164590 7506 90456308
Dark circles under eyes 19.85 17.37 13 164620 611 90463203
Skin haemorrhage 19.85 17.37 7 164626 21373 90442441
Coordination abnormal 19.81 17.37 7 164626 21349 90442465
Status epilepticus 19.66 17.37 5 164628 18869 90444945
Foot fracture 19.62 17.37 12 164621 26594 90437220
Drooling 19.61 17.37 32 164601 4514 90459300
Blood glucose decreased 19.58 17.37 9 164624 23420 90440394
Trismus 19.54 17.37 33 164600 4788 90459026
Vocal cord paralysis 19.38 17.37 23 164610 2407 90461407
Suspected counterfeit product 19.32 17.37 12 164621 514 90463300
Myalgia 19.31 17.37 214 164419 174911 90288903
Cardiac disorder 19.30 17.37 47 164586 56825 90406989
Blood creatine phosphokinase increased 19.25 17.37 20 164613 34003 90429811
Ocular hyperaemia 19.21 17.37 116 164517 33682 90430132
Aphthous ulcer 19.16 17.37 4 164629 17283 90446531
Skin fissures 19.00 17.37 7 164626 20802 90443012
Rales 18.97 17.37 3 164630 15824 90447990
Posture abnormal 18.94 17.37 24 164609 2687 90461127
Injection site scab 18.90 17.37 13 164620 663 90463151
Toxic skin eruption 18.89 17.37 3 164630 15771 90448043
Poor venous access 18.81 17.37 6 164627 19521 90444293
Carpal tunnel syndrome 18.78 17.37 10 164623 23918 90439896
Pulmonary congestion 18.67 17.37 6 164627 19427 90444387
Panic attack 18.66 17.37 96 164537 26269 90437545
Sinus bradycardia 18.63 17.37 4 164629 16948 90446866
Polyneuropathy 18.53 17.37 6 164627 19335 90444479
Iron deficiency anaemia 18.41 17.37 10 164623 23652 90440162
Accidental exposure to product 18.40 17.37 136 164497 42230 90421584
Blood albumin decreased 18.40 17.37 4 164629 16799 90447015
Chromaturia 18.30 17.37 6 164627 19181 90444633
Subarachnoid haemorrhage 18.16 17.37 5 164628 17899 90445915
Pyelonephritis 18.11 17.37 8 164625 21308 90442506
Ileus 17.99 17.37 4 164629 16542 90447272
Pelvic fracture 17.99 17.37 3 164630 15216 90448598
Product container issue 17.99 17.37 21 164612 2160 90461654
Hiatus hernia 17.93 17.37 12 164621 25349 90438465
Underdose 17.86 17.37 163 164470 53854 90409960
Dropped head syndrome 17.84 17.37 9 164624 256 90463558
Tooth abscess 17.78 17.37 4 164629 16409 90447405
Intervertebral disc protrusion 17.75 17.37 14 164619 27182 90436632
Respiratory distress 17.75 17.37 27 164606 38919 90424895
Sensation of foreign body 17.60 17.37 37 164596 6329 90457485
Oral herpes 17.55 17.37 21 164612 33503 90430311
Joint dislocation 17.48 17.37 34 164599 44548 90419266
Pharyngitis 17.48 17.37 9 164624 21938 90441876
Injection site cyst 17.45 17.37 7 164626 114 90463700
Exposure keratitis 17.42 17.37 6 164627 62 90463752
Rheumatic fever 17.37 17.37 382 164251 152739 90311075

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
Drug ineffective 2303.99 25.28 1813 13212 628384 41977926
Off label use 1151.14 25.28 1248 13777 637087 41969223
Product preparation error 914.14 25.28 232 14793 4546 42601764
Therapeutic response decreased 593.97 25.28 280 14745 36732 42569578
Multiple use of single-use product 537.37 25.28 98 14927 329 42605981
Eyelid ptosis 402.76 25.28 132 14893 6529 42599781
Nightmare 400.19 25.28 189 14836 24823 42581487
Injection site pain 383.87 25.28 244 14781 57554 42548756
Sedation 370.53 25.28 191 14834 30284 42576026
Wrong technique in product usage process 336.43 25.28 201 14824 42434 42563876
Nephrolithiasis 286.25 25.28 172 14853 36658 42569652
Dysphagia 284.16 25.28 222 14803 72497 42533813
Hyperhidrosis 232.06 25.28 217 14808 90295 42516015
Muscular weakness 204.06 25.28 195 14830 83303 42523007
Migraine 203.36 25.28 121 14904 25293 42581017
Head discomfort 162.07 25.28 63 14962 5114 42601196
Botulism 148.58 25.28 30 14995 192 42606118
Neck pain 137.72 25.28 101 14924 29913 42576397
Product preparation issue 137.53 25.28 38 14987 1037 42605273
Product storage error 127.13 25.28 67 14958 11073 42595237
Neuromuscular toxicity 114.57 25.28 22 15003 104 42606206
Poor quality product administered 93.76 25.28 34 14991 2274 42604036
Headache 89.80 25.28 234 14791 239135 42367175
Injection site swelling 89.05 25.28 62 14963 16911 42589399
Product used for unknown indication 81.50 25.28 26 14999 1175 42605135
Acute kidney injury 80.47 25.28 16 15009 367321 42238989
Brow ptosis 76.46 25.28 11 15014 0 42606310
Product use in unapproved indication 72.89 25.28 184 14841 184272 42422038
Facial paresis 69.13 25.28 30 14995 3220 42603090
Therapeutic response shortened 67.58 25.28 48 14977 13506 42592804
Anaemia 66.16 25.28 10 15015 280268 42326042
Residual urine volume increased 56.32 25.28 9 15016 9 42606301
Postnatal growth restriction 54.90 25.28 13 15012 187 42606123
Autonomic dysreflexia 54.39 25.28 11 15014 71 42606239
Diarrhoea 53.96 25.28 50 14975 460799 42145511
Drug interaction 53.66 25.28 14 15011 266985 42339325
Death 49.60 25.28 309 14716 470876 42135434
Toxicity to various agents 46.05 25.28 12 15013 229124 42377186
Diplopia 44.92 25.28 45 14980 20271 42586039
Urinary retention 44.32 25.28 64 14961 42150 42564160
Thrombocytopenia 42.18 25.28 8 15017 190271 42416039
Epilepsy 40.44 25.28 48 14977 26123 42580187
Urethral haemorrhage 38.30 25.28 12 15013 511 42605799
Drug ineffective for unapproved indication 37.27 25.28 62 14963 46101 42560209
Therapeutic product effect decreased 36.29 25.28 56 14969 39094 42567216
Injection site rash 35.05 25.28 23 15002 5689 42600621
Injection site erythema 34.48 25.28 39 14986 20156 42586154
Product quality issue 31.33 25.28 35 14990 17847 42588463
Hypotension 31.21 25.28 27 14998 257604 42348706
Platelet count decreased 30.33 25.28 6 15019 138575 42467735
Burning sensation 29.95 25.28 37 14988 20976 42585334
Injection site oedema 29.12 25.28 9 15016 366 42605944
Overdose 28.74 25.28 92 14933 105172 42501138
Pancytopenia 28.20 25.28 4 15021 117739 42488571
Nausea 27.63 25.28 236 14789 396563 42209747
Paralysis 26.39 25.28 21 15004 6999 42599311
Aspiration 26.31 25.28 32 14993 17854 42588456
Renal failure 26.17 25.28 9 15016 143717 42462593
Persistent left superior vena cava 26.15 25.28 5 15020 23 42606287
Renal impairment 25.80 25.28 4 15021 110224 42496086

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
Drug ineffective 6367.34 19.70 8456 126968 1512084 108941791
Product preparation error 5053.32 19.70 1382 134042 9497 110444378
Eyelid ptosis 3143.53 19.70 1002 134422 12325 110441550
Off label use 2399.82 19.70 5483 129941 1494702 108959173
Multiple use of single-use product 2292.76 19.70 485 134939 811 110453064
Therapeutic response decreased 1938.34 19.70 1299 134125 95200 110358675
Wrong technique in product usage process 1569.58 19.70 1098 134326 86250 110367625
Injection site pain 1345.94 19.70 1356 134068 176566 110277309
Botulism 853.46 19.70 184 135240 353 110453522
Facial paresis 796.61 19.70 295 135129 5818 110448057
Brow ptosis 786.28 19.70 150 135274 89 110453786
Blepharospasm 775.48 19.70 597 134827 54254 110399621
Product preparation issue 746.89 19.70 231 135193 2548 110451327
Muscular weakness 654.17 19.70 1126 134298 247342 110206533
Acute kidney injury 652.53 19.70 30 135394 635400 109818475
Product quality issue 637.18 19.70 618 134806 76681 110377194
Migraine 628.18 19.70 905 134519 170747 110283128
Neck pain 611.74 19.70 754 134670 122376 110331499
Swelling face 599.29 19.70 649 134775 91672 110362203
Epilepsy 559.05 19.70 651 134773 99558 110354317
Dysphagia 553.44 19.70 804 134620 152796 110301079
Taste disorder 537.42 19.70 522 134902 64865 110389010
Injection site swelling 524.26 19.70 502 134922 61288 110392587
Anaemia 515.87 19.70 41 135383 547045 109906830
Neuromuscular toxicity 496.62 19.70 113 135311 308 110453567
Drug ineffective for unapproved indication 485.55 19.70 614 134810 102224 110351651
Breast cancer stage III 478.49 19.70 536 134888 78581 110375294
Nail disorder 452.78 19.70 450 134974 57485 110396390
Poor quality product administered 444.32 19.70 179 135245 4462 110449413
Onychomadesis 439.46 19.70 398 135026 45265 110408610
Neutropenia 423.22 19.70 7 135417 374613 110079262
Hypoaesthesia 410.84 19.70 1070 134354 313153 110140722
Back injury 392.44 19.70 380 135044 47019 110406856
Therapeutic response shortened 387.72 19.70 308 135116 29275 110424600
Drug interaction 385.31 19.70 73 135351 500110 109953765
Toxicity to various agents 366.20 19.70 72 135352 480483 109973392
Febrile neutropenia 366.15 19.70 4 135420 316763 110137112
Headache 357.26 19.70 2066 133358 880311 109573564
Thrombocytopenia 352.85 19.70 18 135406 348867 110105008
Facet joint syndrome 347.34 19.70 506 134918 96322 110357553
Gastrooesophageal reflux disease 319.84 19.70 691 134733 179285 110274590
Wound infection 315.81 19.70 483 134941 95982 110357893
Eye swelling 311.99 19.70 285 135139 32763 110421112
Paraesthesia 307.86 19.70 888 134536 275633 110178242
Hypercholesterolaemia 300.43 19.70 457 134967 90380 110363495
Hypotension 300.18 19.70 133 135291 523716 109930159
Bursitis 299.39 19.70 556 134868 129362 110324513
Pyrexia 298.19 19.70 399 135025 897866 109556009
Onychomycosis 296.80 19.70 297 135127 38234 110415641
Product storage error 290.69 19.70 229 135195 21499 110432376
Peripheral venous disease 287.87 19.70 430 134994 83687 110370188
Product label confusion 279.95 19.70 228 135196 22449 110431426
Completed suicide 275.90 19.70 4 135420 242377 110211498
Vision blurred 269.97 19.70 530 134894 128492 110325383
Sepsis 266.86 19.70 41 135383 327305 110126570
Eyelid oedema 264.79 19.70 188 135236 15074 110438801
Adverse reaction 255.80 19.70 243 135181 29351 110424524
Finger deformity 252.90 19.70 254 135170 32838 110421037
Live birth 251.90 19.70 365 135059 69119 110384756
Facial asymmetry 241.26 19.70 76 135348 894 110452981
Coeliac disease 234.75 19.70 277 135147 42910 110410965
Pancytopenia 232.23 19.70 5 135419 209608 110244267
Lip dry 228.88 19.70 427 134997 99656 110354219
Haemoglobin decreased 219.89 19.70 24 135400 248703 110205172
Disease progression 219.73 19.70 22 135402 244012 110209863
Dry mouth 218.43 19.70 638 134786 199310 110254565
Platelet count decreased 214.91 19.70 18 135406 230425 110223450
Dysphonia 213.84 19.70 355 135069 75574 110378301
Type 2 diabetes mellitus 213.59 19.70 586 134838 176646 110277229
Renal failure 213.23 19.70 17 135407 226557 110227318
Obesity 204.46 19.70 438 134986 112913 110340962
Renal impairment 203.05 19.70 6 135418 188439 110265436
Diplopia 202.15 19.70 253 135171 41641 110412234
Diarrhoea 200.69 19.70 720 134704 1138785 109315090
Hyponatraemia 200.25 19.70 18 135406 217635 110236240
Folliculitis 199.71 19.70 552 134872 167101 110286774
Injection site reaction 198.67 19.70 376 135048 88694 110365181
Psoriatic arthropathy 190.67 19.70 602 134822 196159 110257716
Grip strength decreased 188.25 19.70 346 135078 79828 110374047
Gait inability 182.63 19.70 469 134955 135907 110317968
Drug effect less than expected 182.37 19.70 113 135311 7207 110446668
Atrial fibrillation 179.89 19.70 32 135392 229610 110224265
Blood creatinine increased 177.01 19.70 12 135412 182877 110270998
Fibromyalgia 174.93 19.70 533 134891 170376 110283499
Nightmare 173.80 19.70 226 135198 38637 110415238
Infusion site reaction 171.80 19.70 155 135269 17527 110436348
Incorrect route of product administration 171.72 19.70 293 135131 63768 110390107
Facial paralysis 170.76 19.70 178 135246 24036 110429839
Cardiac failure 168.66 19.70 17 135407 187609 110266266
Duodenal ulcer perforation 166.97 19.70 538 134886 177162 110276713
Oedema peripheral 166.37 19.70 98 135326 328562 110125313
Cough 164.34 19.70 194 135230 461447 109992428
Helicobacter infection 163.13 19.70 542 134882 181335 110272540
Muscle spasms 162.32 19.70 723 134701 277434 110176441
Head discomfort 162.27 19.70 155 135269 18845 110435030
Alanine aminotransferase increased 161.73 19.70 18 135406 183755 110270120
Muscle injury 160.19 19.70 456 134968 140351 110313524
Joint range of motion decreased 160.04 19.70 416 135008 121416 110332459
Pleural effusion 160.00 19.70 16 135408 177693 110276182
Dehydration 159.87 19.70 71 135353 279440 110174435
Gastrointestinal haemorrhage 159.77 19.70 11 135413 165507 110288368
Memory impairment 156.70 19.70 564 134860 196380 110257495
Interstitial lung disease 155.61 19.70 3 135421 139331 110314544
Inflammation 155.12 19.70 555 134869 192683 110261192
Cardiac arrest 155.01 19.70 27 135397 196726 110257149
Pulmonary embolism 153.31 19.70 37 135387 214437 110239438
Periorbital swelling 152.61 19.70 91 135333 5414 110448461
Drug intolerance 151.62 19.70 933 134491 405579 110048296
Infection 147.12 19.70 136 135288 362064 110091811
Neuropathy peripheral 147.07 19.70 22 135402 179255 110274620
Urticaria 145.92 19.70 773 134651 318084 110135791
Injection site rash 145.51 19.70 161 135263 23258 110430617
Aspartate aminotransferase increased 145.04 19.70 14 135410 159922 110293953
White blood cell count decreased 144.80 19.70 50 135374 229340 110224535
Cardiac failure congestive 142.98 19.70 11 135413 150989 110302886
Product dose omission issue 142.71 19.70 111 135313 321671 110132204
Liver function test increased 142.56 19.70 327 135097 88221 110365654
Pemphigus 139.21 19.70 576 134848 213994 110239881
Anti-cyclic citrullinated peptide antibody positive 138.72 19.70 514 134910 181470 110272405
Night sweats 138.15 19.70 419 135005 133564 110320311
Pneumonia 137.99 19.70 579 134845 876135 109577740
Influenza like illness 137.40 19.70 322 135102 88090 110365785
Skin tightness 135.67 19.70 85 135339 5528 110448347
Myocardial infarction 135.61 19.70 34 135390 192049 110261826
Injection site erythema 134.55 19.70 332 135092 93844 110360031
Intentional overdose 133.34 19.70 7 135417 132494 110321381
Facial pain 130.74 19.70 125 135299 15214 110438661
Multiple organ dysfunction syndrome 130.65 19.70 16 135408 151694 110302181
Blood cholesterol increased 130.21 19.70 509 134915 184276 110269599
Drug abuse 129.98 19.70 29 135395 177382 110276493
Hypokalaemia 129.37 19.70 32 135392 182416 110271459
C-reactive protein increased 128.27 19.70 568 134856 217351 110236524
Injection site nodule 126.71 19.70 76 135348 4570 110449305
Osteoarthritis 123.80 19.70 497 134927 182126 110271749
Irritable bowel syndrome 123.64 19.70 462 134962 163753 110290122
Injection site mass 122.52 19.70 151 135273 24462 110429413
Pericarditis 121.40 19.70 561 134863 218553 110235322
Glossodynia 121.23 19.70 566 134858 221438 110232437
Rheumatic fever 119.56 19.70 376 135048 122203 110331672
Constipation 119.28 19.70 158 135266 357628 110096247
Septic shock 116.93 19.70 25 135399 157503 110296372
Systemic lupus erythematosus 115.91 19.70 616 134808 253722 110200153
Neutrophil count decreased 113.97 19.70 9 135415 120932 110332943
Liver injury 113.92 19.70 424 135000 149989 110303886
Leukopenia 113.79 19.70 22 135402 148769 110305106
Hypoxia 110.69 19.70 14 135410 129501 110324374
Hand deformity 109.85 19.70 544 134880 217962 110235913
Swelling 108.55 19.70 769 134655 350272 110103603
Maternal exposure during pregnancy 107.19 19.70 604 134820 254279 110199596
Eyelid sensory disorder 107.12 19.70 25 135399 79 110453796
Product use in unapproved indication 106.84 19.70 923 134501 446454 110007421
Suicide attempt 105.51 19.70 5 135419 103389 110350486
Musculoskeletal pain 104.64 19.70 473 134951 182550 110271325
Swollen tongue 103.95 19.70 229 135195 60133 110393742
Bradycardia 103.26 19.70 31 135393 155486 110298389
Abdominal pain 102.48 19.70 306 135118 512683 109941192
Lagophthalmos 101.89 19.70 35 135389 549 110453326
Respiratory failure 100.99 19.70 70 135354 215262 110238613
Neovascularisation 100.62 19.70 47 135377 1690 110452185
Rhabdomyolysis 100.54 19.70 14 135410 120387 110333488
Haematochezia 99.92 19.70 12 135412 115512 110338363
Hypoglycaemia 98.14 19.70 13 135411 116091 110337784
Metabolic acidosis 98.11 19.70 6 135418 99738 110354137
Coma 97.74 19.70 14 135410 117855 110336020
Asthenopia 97.46 19.70 56 135368 3108 110450767
COVID-19 97.14 19.70 94 135330 244966 110208909
Intentional product use issue 96.76 19.70 576 134848 247330 110206545
Facial discomfort 94.92 19.70 30 135394 357 110453518
Deep vein thrombosis 94.49 19.70 27 135397 139860 110314015
Muscle tightness 92.60 19.70 102 135322 14660 110439215
Blister 91.12 19.70 532 134892 226844 110227031
Pulmonary oedema 90.76 19.70 9 135415 100650 110353225
Blood glucose increased 90.56 19.70 25 135399 132471 110321404
Therapeutic product effect decreased 90.49 19.70 560 134864 243756 110210119
Back pain 90.46 19.70 200 135224 370796 110083079
Epistaxis 90.24 19.70 24 135400 130348 110323527
Injection site discomfort 88.53 19.70 71 135353 6836 110447039
Chronic obstructive pulmonary disease 88.14 19.70 14 135410 109144 110344731
Colitis 87.59 19.70 11 135413 102312 110351563
Overlap syndrome 87.20 19.70 79 135345 8980 110444895
Wound 86.60 19.70 537 134887 233900 110219975
International normalised ratio increased 86.01 19.70 5 135419 86767 110367108
Oxygen saturation decreased 84.92 19.70 43 135381 156939 110296936
Lung disorder 84.69 19.70 440 134984 179607 110274268
Blood pressure increased 84.15 19.70 116 135308 258257 110195618
Dyspepsia 83.90 19.70 458 134966 190507 110263368
Agitation 83.77 19.70 18 135406 113033 110340842
Hepatic function abnormal 83.15 19.70 7 135417 89288 110364587
Sedation 82.47 19.70 229 135195 69454 110384421
Death 82.26 19.70 510 134914 698359 109755516
Impaired healing 81.24 19.70 464 134960 196253 110257622
Thrombosis 81.13 19.70 17 135407 108645 110345230
Cardio-respiratory arrest 80.79 19.70 21 135403 115815 110338060
Pneumonitis 80.42 19.70 3 135421 76528 110377347
Injection site paraesthesia 78.30 19.70 31 135393 737 110453138
Depression 77.94 19.70 659 134765 316676 110137199
Decreased appetite 75.45 19.70 313 135111 475533 109978342
Drug reaction with eosinophilia and systemic symptoms 74.91 19.70 7 135417 82088 110371787
Coronary artery disease 74.69 19.70 3 135421 71687 110382188
Rash maculo-papular 74.42 19.70 4 135420 74218 110379657
Chest pain 74.04 19.70 226 135198 376149 110077726
Blood pressure systolic increased 73.33 19.70 8 135416 82983 110370892
Rheumatoid arthritis 72.94 19.70 621 134803 298992 110154883
Synovitis 72.56 19.70 579 134845 273513 110180362
Tachycardia 72.56 19.70 103 135321 226542 110227333
Hepatic enzyme 72.48 19.70 56 135368 5107 110448768
Hepatitis 70.80 19.70 257 135167 89797 110364078
Drug-induced liver injury 70.62 19.70 313 135111 119754 110334121
Injection site granuloma 69.15 19.70 18 135406 99 110453776
Muscle twitching 68.74 19.70 128 135296 29807 110424068
Productive cough 68.59 19.70 27 135397 114278 110339597
Injection site oedema 68.54 19.70 37 135387 1817 110452058
Urinary tract infection 68.49 19.70 190 135234 326092 110127783
Sleep disorder 68.39 19.70 447 134977 198197 110255678
Haemoptysis 68.10 19.70 5 135419 71349 110382526
Melaena 68.03 19.70 4 135420 68753 110385122
Blood bilirubin increased 67.95 19.70 7 135417 75965 110377910
Hypocalcaemia 67.22 19.70 3 135421 65363 110388512
Sinusitis 66.65 19.70 167 135257 296521 110157354
Encephalopathy 66.34 19.70 10 135414 81045 110372830
Syncope 65.87 19.70 91 135333 202445 110251430
Hepatotoxicity 64.90 19.70 3 135421 63397 110390478
Plasma cell myeloma 64.35 19.70 3 135421 62933 110390942
Haematuria 64.04 19.70 12 135412 82993 110370882
Swelling of eyelid 64.00 19.70 58 135366 6595 110447280
Injection site urticaria 63.19 19.70 91 135333 17124 110436751
Blood alkaline phosphatase increased 62.26 19.70 7 135417 70928 110382947
Diabetes mellitus 62.10 19.70 22 135402 99359 110354516
Product administered at inappropriate site 61.92 19.70 52 135372 5341 110448534
Transaminases increased 61.78 19.70 4 135420 63386 110390489
Hypoaesthesia oral 61.13 19.70 89 135335 16913 110436962
Abdominal pain upper 61.03 19.70 675 134749 348436 110105439
Cataract 60.24 19.70 12 135412 79473 110374402
Dizziness 60.19 19.70 1194 134230 696999 109756876
Vascular malformation 59.79 19.70 26 135398 788 110453087
Weight decreased 59.55 19.70 333 135091 467724 109986151
Mental status changes 58.73 19.70 11 135413 76111 110377764
Dyspnoea exertional 58.57 19.70 27 135397 104033 110349842
Eosinophilia 58.47 19.70 3 135421 57933 110395942
Cardiogenic shock 57.77 19.70 3 135421 57335 110396540
Liver function test abnormal 57.60 19.70 8 135416 68942 110384933
Injection site bruising 57.27 19.70 165 135259 51098 110402777
Post-traumatic neck syndrome 57.01 19.70 37 135387 2558 110451317
Acute myocardial infarction 56.89 19.70 16 135408 83761 110370114
Bronchitis 56.85 19.70 65 135359 156967 110296908
Haemorrhage 56.55 19.70 30 135394 106662 110347213
Influenza 55.97 19.70 75 135349 169026 110284849
Prescribed overdose 55.87 19.70 234 135190 87347 110366528
Therapeutic product effect incomplete 55.56 19.70 466 134958 223339 110230536
Cerebrovascular accident 55.46 19.70 85 135339 181199 110272676
Pancreatitis acute 55.37 19.70 5 135419 60269 110393606
Fall 54.76 19.70 474 134950 603008 109850867
Periorbital oedema 54.75 19.70 65 135359 10127 110443748
Normal newborn 54.56 19.70 97 135327 21799 110432076
Red blood cell count decreased 54.25 19.70 8 135416 65915 110387960
Paranasal cyst 54.04 19.70 25 135399 879 110452996
Full blood count abnormal 53.29 19.70 4 135420 56048 110397827
Cerebral haemorrhage 53.20 19.70 8 135416 64960 110388915
Electrocardiogram QT prolonged 52.98 19.70 34 135390 108926 110344949
Injection site indentation 52.78 19.70 18 135406 276 110453599
Endometriosis 52.27 19.70 43 135381 4291 110449584
Pruritus 52.22 19.70 458 134966 581102 109872773
Arthropathy 52.12 19.70 560 134864 286962 110166913
Nephrolithiasis 52.07 19.70 189 135235 66023 110387852
Patient dissatisfaction with treatment 51.90 19.70 19 135405 362 110453513
Pericardial effusion 51.88 19.70 5 135419 57212 110396663
Blood pressure decreased 51.87 19.70 39 135385 115052 110338823
Clostridium difficile infection 51.68 19.70 3 135421 52126 110401749
Jaundice 51.60 19.70 6 135418 59230 110394645
Mephisto sign 51.36 19.70 9 135415 0 110453875
Soft tissue injury 51.35 19.70 33 135391 2243 110451632
Mastication disorder 51.04 19.70 39 135385 3499 110450376
Rectal haemorrhage 51.00 19.70 43 135381 119790 110334085
Injection site papule 50.61 19.70 25 135399 1019 110452856
Orthostatic hypotension 50.21 19.70 10 135414 66239 110387636
Haematocrit decreased 50.07 19.70 10 135414 66107 110387768
Product packaging issue 49.94 19.70 29 135395 1642 110452233
Arrhythmia 49.70 19.70 12 135412 69563 110384312
Unresponsive to stimuli 49.68 19.70 9 135415 63781 110390094
Skin ulcer 49.53 19.70 9 135415 63636 110390239
Hepatic cytolysis 49.42 19.70 5 135419 55048 110398827
Gamma-glutamyltransferase increased 49.18 19.70 8 135416 61301 110392574
Arthritis 48.98 19.70 81 135343 167505 110286370
Hallucination 48.84 19.70 32 135392 101400 110352475
Hypervolaemia 48.56 19.70 3 135421 49457 110404418
Acute respiratory failure 48.17 19.70 16 135408 75244 110378631
Leukocytosis 48.04 19.70 5 135419 53823 110400052
Cellulitis 48.01 19.70 50 135374 125966 110327909
Fluid retention 47.84 19.70 28 135396 94279 110359596
Hepatic steatosis 47.83 19.70 3 135421 48828 110405047
Mobility decreased 47.57 19.70 472 134952 236950 110216925
Somnolence 47.51 19.70 195 135229 297254 110156621
Wheezing 47.13 19.70 499 134925 254731 110199144
Chills 47.02 19.70 102 135322 190478 110263397
Blood urea increased 46.81 19.70 6 135418 54951 110398924
Haematemesis 46.78 19.70 8 135416 59100 110394775
Hypersensitivity 46.61 19.70 724 134700 403274 110050601
Ventricular tachycardia 46.34 19.70 4 135420 50005 110403870
Hostility 46.28 19.70 33 135391 2663 110451212
Dyspnoea 45.85 19.70 1020 134404 1105852 109348023
Libido increased 45.72 19.70 32 135392 2507 110451368
Contraindicated product administered 45.66 19.70 485 134939 247782 110206093
Stevens-Johnson syndrome 45.59 19.70 3 135421 46898 110406977
Hypercalcaemia 45.31 19.70 3 135421 46654 110407221
Liver disorder 45.16 19.70 65 135359 142178 110311697
Aggression 44.74 19.70 9 135415 59201 110394674
Fatigue 44.72 19.70 1141 134283 1214817 109239058
Stomatitis 44.71 19.70 517 134907 269725 110184150
Eye pain 44.59 19.70 149 135275 49950 110403925
Ophthalmoplegia 44.45 19.70 36 135388 3514 110450361
Disease recurrence 44.38 19.70 10 135414 60774 110393101
Blood pressure fluctuation 44.36 19.70 18 135406 74806 110379069
Injection site pruritus 44.35 19.70 151 135273 51107 110402768
Blood creatine phosphokinase increased 44.27 19.70 17 135407 73060 110380815
C-reactive protein abnormal 44.10 19.70 291 135133 129404 110324471
Overdose 44.07 19.70 459 134965 233335 110220540
Candida infection 44.05 19.70 4 135420 48005 110405870
Product distribution issue 44.00 19.70 39 135385 4307 110449568
Incorrect product administration duration 43.79 19.70 85 135339 20413 110433462
Product temperature excursion issue 43.11 19.70 21 135403 830 110453045
Product prescribing error 42.78 19.70 6 135418 51325 110402550
Vomiting 42.46 19.70 823 134601 909852 109544023
Facial spasm 42.40 19.70 21 135403 861 110453014
Ill-defined disorder 42.38 19.70 333 135091 156520 110297355
Psychotic disorder 42.34 19.70 6 135418 50931 110402944
Heart rate decreased 41.37 19.70 25 135399 82731 110371144
Basal cell carcinoma 40.93 19.70 4 135420 45266 110408609
Cervicogenic headache 40.91 19.70 14 135410 217 110453658
Dry skin 40.69 19.70 43 135381 107610 110346265
Alopecia 40.30 19.70 649 134775 364104 110089771
Sternal fracture 40.20 19.70 33 135391 3283 110450592
Pineal gland cyst 40.10 19.70 14 135410 231 110453644
Sinus tachycardia 40.05 19.70 4 135420 44489 110409386
Hypocholesterolaemia 39.64 19.70 44 135380 6377 110447498
Pancreatitis 39.27 19.70 34 135390 93499 110360376
Skin indentation 39.17 19.70 9 135415 26 110453849
Angioedema 39.11 19.70 230 135194 98270 110355605
Drug dependence 39.08 19.70 7 135417 50013 110403862
Depressed level of consciousness 39.01 19.70 48 135376 112230 110341645
Burning sensation 38.87 19.70 178 135246 69034 110384841
Central nervous system function test abnormal 38.67 19.70 9 135415 28 110453847
Renal disorder 38.49 19.70 7 135417 49472 110404403
Ulcer 38.49 19.70 4 135420 43112 110410763
Product used for unknown indication 38.31 19.70 26 135398 1937 110451938
Speech disorder 38.10 19.70 163 135261 61406 110392469
Treatment noncompliance 37.98 19.70 21 135403 72969 110380906
Lower respiratory tract infection 37.96 19.70 460 134964 242646 110211229
Injection site hypoaesthesia 37.88 19.70 18 135406 673 110453202
Restlessness 37.72 19.70 11 135413 56248 110397627
Paralysis 37.45 19.70 68 135356 15532 110438343
Manufacturing product shipping issue 37.37 19.70 11 135413 101 110453774
Flatulence 37.24 19.70 9 135415 52140 110401735
Treatment failure 37.15 19.70 510 134914 276724 110177151
Shock 36.82 19.70 10 135414 53578 110400297
Injury 36.76 19.70 355 135069 176910 110276965
Diverticulitis 36.75 19.70 10 135414 53512 110400363
Acute respiratory distress syndrome 36.42 19.70 10 135414 53188 110400687
Ischaemic stroke 36.39 19.70 4 135420 41259 110412616
Drug resistance 36.05 19.70 12 135412 56362 110397513
Sleep disorder due to general medical condition, insomnia type 34.80 19.70 47 135377 105596 110348279
Injection site haemorrhage 34.68 19.70 104 135320 32924 110420951
Strabismus 34.63 19.70 31 135393 3468 110450407
Body temperature decreased 34.10 19.70 3 135421 36932 110416943
Disseminated intravascular coagulation 34.00 19.70 5 135419 41281 110412594
Photophobia 33.81 19.70 88 135336 25683 110428192
Throat tightness 33.81 19.70 104 135320 33385 110420490
Exposure during pregnancy 33.60 19.70 333 135091 167091 110286784
Coagulopathy 33.58 19.70 5 135419 40906 110412969
Injection site inflammation 33.50 19.70 35 135389 4736 110449139
Dry eye 33.21 19.70 146 135278 55647 110398228
Cerebral infarction 33.21 19.70 11 135413 51827 110402048
Loss of consciousness 33.05 19.70 126 135298 196180 110257695
Tension headache 32.64 19.70 49 135375 9569 110444306
Underdose 32.44 19.70 159 135265 63395 110390480
Staphylococcal infection 32.43 19.70 23 135401 69921 110383954
Hallucination, visual 32.15 19.70 5 135419 39600 110414275
White blood cell count increased 31.99 19.70 43 135381 96799 110357076
Eczema 31.93 19.70 25 135399 72268 110381607
Paradoxical drug reaction 31.88 19.70 49 135375 9768 110444107
Mastoiditis 31.69 19.70 26 135398 2585 110451290
Oedema 31.46 19.70 141 135283 209835 110244040
Oral candidiasis 31.42 19.70 8 135416 44752 110409123
Colitis ulcerative 31.42 19.70 29 135395 77334 110376541
Skin wrinkling 31.34 19.70 21 135403 1532 110452343
Product reconstitution quality issue 31.26 19.70 13 135411 352 110453523
Intestinal obstruction 31.23 19.70 13 135411 53214 110400661
Acute hepatic failure 31.01 19.70 4 135420 36464 110417411
Altered state of consciousness 30.83 19.70 16 135408 57610 110396265
Pharyngeal hypoaesthesia 30.81 19.70 14 135410 472 110453403
Hypophagia 30.64 19.70 13 135411 52613 110401262
Cholelithiasis 30.54 19.70 20 135404 63402 110390473
Lymphocyte count decreased 30.47 19.70 16 135408 57227 110396648
Lid sulcus deepened 30.47 19.70 11 135413 201 110453674
Joint injury 30.39 19.70 6 135418 39988 110413887
Arthralgia 30.36 19.70 725 134699 778907 109674968
Blood calcium decreased 30.32 19.70 4 135420 35841 110418034
Cardiomyopathy 30.21 19.70 3 135421 33522 110420353
Application site acne 30.09 19.70 6 135418 6 110453869
Hypothyroidism 30.00 19.70 27 135397 72872 110381003
Lip disorder 29.99 19.70 21 135403 1646 110452229
Diaphragmatic rupture 29.93 19.70 11 135413 212 110453663
Blood potassium increased 29.90 19.70 3 135421 33246 110420629
Pulmonary mass 29.62 19.70 5 135419 37296 110416579
Musculoskeletal stiffness 29.45 19.70 494 134930 279328 110174547
Obstructive airways disorder 29.20 19.70 10 135414 46139 110407736
Haematoma 28.76 19.70 18 135406 58458 110395417
Cognitive disorder 28.76 19.70 39 135385 87472 110366403
Intranasal hypoaesthesia 28.53 19.70 5 135419 0 110453875
Angina pectoris 28.21 19.70 21 135403 62274 110391601
Rash pruritic 28.09 19.70 48 135376 98021 110355854
Blood pressure diastolic decreased 28.08 19.70 5 135419 35880 110417995
Delirium 28.03 19.70 79 135345 134946 110318929
Erythema of eyelid 27.99 19.70 29 135395 3886 110449989
Upper respiratory tract infection 27.88 19.70 76 135348 131252 110322623
Ventricular fibrillation 27.84 19.70 8 135416 41305 110412570
Circulatory collapse 27.76 19.70 9 135415 42984 110410891
Dermatochalasis 27.62 19.70 8 135416 69 110453806
Abdominal distension 27.62 19.70 332 135092 174771 110279104
Herpes zoster 27.56 19.70 57 135367 108322 110345553
Mitral valve incompetence 27.53 19.70 4 135420 33325 110420550
Lacrimation increased 27.50 19.70 92 135332 30858 110423017
Abdominal pain lower 27.49 19.70 6 135418 37277 110416598
Eyelid pain 27.46 19.70 15 135409 754 110453121
Ejection fraction decreased 27.40 19.70 8 135416 40872 110413003
Gastritis 27.15 19.70 16 135408 53683 110400192
Migraine without aura 27.08 19.70 14 135410 629 110453246
Abnormal sensation in eye 27.02 19.70 22 135402 2164 110451711
Bone pain 26.95 19.70 24 135400 65109 110388766
Premature delivery 26.94 19.70 3 135421 30629 110423246
Ocular discomfort 26.88 19.70 42 135382 8491 110445384
Blood sodium decreased 26.61 19.70 7 135417 38312 110415563
Gastric ulcer 26.32 19.70 8 135416 39819 110414056
Mouth ulceration 26.30 19.70 13 135411 48125 110405750
Injection site haematoma 26.30 19.70 32 135392 5114 110448761
Small intestinal obstruction 26.30 19.70 4 135420 32209 110421666
Asthenia 26.25 19.70 1062 134362 687937 109765938
Asthma 26.17 19.70 189 135235 250102 110203773
Neuroleptic malignant syndrome 26.11 19.70 5 135419 34054 110419821
Skin exfoliation 25.94 19.70 42 135382 87609 110366266
Drug specific antibody 25.93 19.70 24 135400 2804 110451071
Subarachnoid haemorrhage 25.89 19.70 3 135421 29699 110424176
Fungal infection 25.89 19.70 15 135409 50791 110403084
Bacterial infection 25.82 19.70 12 135412 46024 110407851
Heart rate increased 25.73 19.70 90 135334 143744 110310131
Suspected product quality issue 25.11 19.70 13 135411 586 110453289
Atelectasis 24.94 19.70 7 135417 36705 110417170
Nerve injury 24.83 19.70 46 135378 10667 110443208
Neutrophil count increased 24.70 19.70 6 135418 34646 110419229
Subdural haematoma 24.68 19.70 7 135417 36447 110417428
Peritonitis 24.55 19.70 5 135419 32602 110421273
Localised infection 24.48 19.70 11 135413 43037 110410838
Femur fracture 24.31 19.70 12 135412 44457 110409418
Tachypnoea 24.14 19.70 9 135415 39386 110414489
Bronchospasm 24.13 19.70 4 135420 30235 110423640
Polyneuropathy 23.91 19.70 5 135419 32007 110421868
Anaphylactic shock 23.83 19.70 17 135407 51529 110402346
Calcification of muscle 23.81 19.70 9 135415 188 110453687
Disorientation 23.73 19.70 31 135393 70640 110383235
Device dislocation 23.58 19.70 5 135419 31699 110422176
Blood potassium decreased 23.54 19.70 19 135405 54095 110399780
Psoriasis 23.46 19.70 90 135334 139903 110313972
Sinus bradycardia 23.31 19.70 4 135420 29479 110424396
Lymphopenia 23.27 19.70 10 135414 40160 110413715
Eyelid disorder 23.20 19.70 21 135403 2384 110451491
Osteomyelitis 23.04 19.70 8 135416 36592 110417283
Rhinorrhoea 22.87 19.70 58 135366 102608 110351267
Product quality control issue 22.73 19.70 5 135419 11 110453864
Myocardial ischaemia 22.52 19.70 3 135421 26681 110427194
Medication error 22.35 19.70 61 135363 105305 110348570
Choking 22.34 19.70 54 135370 15056 110438819
Pneumonia bacterial 22.05 19.70 3 135421 26258 110427617
Illness 21.94 19.70 42 135382 82129 110371746
Gastroenteritis 21.93 19.70 10 135414 38790 110415085
Rheumatoid factor positive 21.82 19.70 85 135339 131555 110322320
Dementia 21.59 19.70 6 135418 31667 110422208
Blood pressure diastolic abnormal 21.55 19.70 3 135421 25812 110428063
Torticollis 21.50 19.70 23 135401 3198 110450677
Iron deficiency anaemia 21.47 19.70 6 135418 31553 110422322
Respiratory arrest 21.24 19.70 24 135400 58275 110395600
Brain oedema 21.00 19.70 6 135418 31092 110422783
Hyperthyroidism 20.99 19.70 5 135419 29256 110424619
Cardiomegaly 20.85 19.70 5 135419 29125 110424750
Drug eruption 20.76 19.70 21 135403 53638 110400237
Progressive multifocal leukoencephalopathy 20.60 19.70 3 135421 24953 110428922
Transient ischaemic attack 20.54 19.70 29 135395 63953 110389922
Hypoaesthesia eye 20.54 19.70 10 135414 395 110453480
Neoplasm malignant 20.34 19.70 10 135414 37133 110416742
Skin lesion 20.21 19.70 20 135404 51611 110402264
Madarosis 20.13 19.70 23 135401 3440 110450435
Hallucination, auditory 19.97 19.70 4 135420 26393 110427482
Thyroid atrophy 19.96 19.70 9 135415 298 110453577

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
CHEBI has role CHEBI:53784 antispasmodic drug
CHEBI has role CHEBI:176497 geroprotector
MeSH PA D009465 Neuromuscular Agents
MeSH PA D009498 Neurotoxins
MeSH PA D009676 Noxae
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018678 Cholinergic Agents
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D065087 Acetylcholine Release Inhibitors
FDA PE N0000175731 Neuromuscular Blockade
FDA MoA N0000175770 Acetylcholine Release Inhibitors
FDA EPC N0000175771 Acetylcholine Release Inhibitor
FDA EPC N0000193962 Neuromuscular Blocker
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:48407 antiparkinson drug

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

DiseaseRelationSNOMED_IDDOID
Rhytidectomy of glabellar frown lines indication 14667004
Urge urinary incontinence indication 87557004
Urinary frequency indication 162116003
Lower limb spasticity indication 394679006
Upper limb spasticity indication 394680009
Neurogenic bladder indication 398064005
Overactive bladder indication 786457000




🐶 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
Synaptosomal-associated protein 25 Cytosolic other BLOCKER SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE

External reference:

IDSource
4020561 VANDF
4030130 VANDF
CHEBI:3160 CHEBI
CHEMBL4297862 ChEMBL_ID
D00783 KEGG_DRUG
DB00083 DRUGBANK_ID
108890005 SNOMEDCT_US
427412002 SNOMEDCT_US
703368006 SNOMEDCT_US
772950004 SNOMEDCT_US
C0006050 UMLSCUI
CHEMBL2108035 ChEMBL_ID
93384-43-1 SECONDARY_CAS_RN
27317 MMSL
4295 MMSL
d01227 MMSL
d07669 MMSL
013287 NDDF
E211KPY694 UNII
1000104 RXNORM
C545476 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
BOTOX HUMAN PRESCRIPTION DRUG LABEL 1 0023-1145 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 [USPU] INTRADERMAL BLA 31 sections
BOTOX Cosmetic HUMAN PRESCRIPTION DRUG LABEL 1 0023-3919 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 [USPU] INTRAMUSCULAR BLA 31 sections
BOTOX HUMAN PRESCRIPTION DRUG LABEL 1 0023-3921 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 [USPU] INTRADERMAL BLA 31 sections
BOTOX Cosmetic HUMAN PRESCRIPTION DRUG LABEL 1 0023-9232 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 [USPU] INTRAMUSCULAR BLA 31 sections
Xeomin HUMAN PRESCRIPTION DRUG LABEL 1 0259-1605 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 [USPU] INTRAMUSCULAR BLA 30 sections
Xeomin HUMAN PRESCRIPTION DRUG LABEL 1 0259-1610 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 [USPU] INTRAMUSCULAR BLA 30 sections
Xeomin HUMAN PRESCRIPTION DRUG LABEL 1 0259-1620 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 [USPU] INTRAMUSCULAR BLA 30 sections
Xeomin HUMAN PRESCRIPTION DRUG LABEL 1 0259-4110 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 [USPU] INTRAMUSCULAR BLA 30 sections
Xeomin HUMAN PRESCRIPTION DRUG LABEL 1 0259-4150 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 [USPU] INTRAMUSCULAR BLA 30 sections
Dysport HUMAN PRESCRIPTION DRUG LABEL 1 0299-5962 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 300 U INTRAMUSCULAR BLA 33 sections
Dysport HUMAN PRESCRIPTION DRUG LABEL 1 15054-0500 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 U INTRAMUSCULAR BLA 31 sections
Dysport HUMAN PRESCRIPTION DRUG LABEL 1 15054-0530 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 300 U INTRAMUSCULAR BLA 31 sections
Xeomin HUMAN PRESCRIPTION DRUG LABEL 1 46783-160 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 [USPU] INTRAMUSCULAR BLA 31 sections
Xeomin HUMAN PRESCRIPTION DRUG LABEL 1 46783-161 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 [USPU] INTRAMUSCULAR BLA 31 sections
Xeomin HUMAN PRESCRIPTION DRUG LABEL 1 46783-165 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 [USPU] INTRAMUSCULAR BLA 31 sections
Jeuveau HUMAN PRESCRIPTION DRUG LABEL 1 72301-595 POWDER 100 [USPU] INTRAMUSCULAR BLA 28 sections
DAXXIFY HUMAN PRESCRIPTION DRUG LABEL 1 72960-112 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 U INTRAMUSCULAR BLA 31 sections
BOTOX HUMAN PRESCRIPTION DRUG LABEL 1 85766-155 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 [USPU] INTRADERMAL BLA 31 sections