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

Stem definitionDrug idCAS RN
local anaesthetics 2610 94-24-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • tetracaine monohydrochloride
  • pontocaine
  • tetracaine
  • amethocaine
  • laudocaine
  • tetracaine hydrochloride
  • tetracaine HCl
Local ester anesthetic that blocks both the initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions, which results in inhibition of depolarization with resultant blockade of conduction.
  • Molecular weight: 264.37
  • Formula: C15H24N2O2
  • CLOGP: 3.83
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 41.57
  • ALOGS: -2.68
  • ROTB: 9
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 2.295 Moderate 0.67
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.209 Moderate 0.67
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 50.933 10^-6 cm/s Moderate 0.67
dh-clint Dog hepatocyte intrinsic clearance 1093.956 uL/min/10^6 cells Moderate 0.67
dppb Dog plasma protein binding (% unbound) 31.170 % Moderate 0.67
fcs-ppb Fetal calf serum protein binding (% unbound) 44.440 % Moderate 0.67
herg hERG pIC50 5.174 pIC50 Moderate 0.67
hh-clint Human hepatocyte intrinsic clearance 123.880 uL/min/10^6 cells Moderate 0.67
hlm-clint Human liver microsomal intrinsic clearance 157.761 uL/min/mg protein Moderate 0.67
hppb Human plasma protein binding (% unbound) 37.220 % Moderate 0.67
kinase-safety-class ACVR2A,ACVR2B,AKT1,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK4,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK1,JAK2,JAK3,KIT,MAP2K6,MAP3K1,MAP3K10,MAP3K21,MAP3K7,MAP4K1,MAP4K3,MAPK10,MAPK12,MAPK7,MAPK9,MARK4,MELK,MET,MTOR,NTRK2,PAK4,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PLK1,PRKCD,PRKDC,SGK1,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1,ULK2 63
kinase-selectivity-class AXL,BRAF,GRK2,MAPK7,SIK2,STK33,TEK,TTK 8
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.137 Moderate 0.67
mh-clint Mouse hepatocyte intrinsic clearance 549.541 Moderate 0.67
mppb Mouse plasma protein binding (% unbound) 58.330 Moderate 0.67
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.166 Moderate 0.67
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 56.520 % Moderate 0.67
rh-clint Rat hepatocyte intrinsic clearance 360.579 uL/min/10^6 cells Moderate 0.67
rh-fuinc Rat hepatocyte fraction unbound in incubation 85.910 % Moderate 0.67
rppb Rat plasma protein binding (% unbound) 43.810 % Moderate 0.67
solubility-dd Solubility at pH 7.4 in DMSO 937.562 uM Moderate 0.67

Approvals:

DateAgencyCompanyOrphan
June 23, 2005 FDA GALEN SPECIALTY

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
Local anaesthetic systemic toxicity 882.40 9.48 253 74389 3247 90550558
Maternal exposure during delivery 323.04 9.48 121 74521 3725 90550080
Toxic anterior segment syndrome 300.75 9.48 100 74542 2150 90551655
Anaphylactic reaction 259.94 9.48 340 74302 87184 90466621
Cardiac arrest 255.03 9.48 370 74272 104565 90449240
Anaphylactic shock 248.39 9.48 207 74435 31410 90522395
Pemphigus 214.25 9.48 14 74628 326850 90226955
Hand deformity 209.12 9.48 8 74634 296354 90257451
Glossodynia 196.35 9.48 19 74623 321760 90232045
Synovitis 192.22 9.48 23 74619 329729 90224076
Systemic lupus erythematosus 190.72 9.48 34 74608 361862 90191943
Kounis syndrome 174.01 9.48 69 74573 2484 90551321
Contraindicated product administered 171.02 9.48 29 74613 320110 90233695
Anti-cyclic citrullinated peptide antibody positive 164.68 9.48 7 74635 236426 90317379
Methaemoglobinaemia 156.24 9.48 73 74569 3942 90549863
Pericarditis 154.59 9.48 20 74622 270131 90283674
Duodenal ulcer perforation 152.64 9.48 7 74635 221281 90332524
Hepatic enzyme increased 149.73 9.48 55 74587 360681 90193124
Sinusitis 148.17 9.48 617 74025 342471 90211334
Joint swelling 147.60 9.48 119 74523 503181 90050624
Hypotension 145.88 9.48 592 74050 324805 90229000
Infusion site pain 142.25 9.48 123 74519 19615 90534190
Wound 136.60 9.48 40 74602 302940 90250865
Arthropathy 135.72 9.48 66 74576 366176 90187629
Generalised tonic-clonic seizure 135.02 9.48 155 74487 34748 90519057
Infusion site swelling 125.12 9.48 92 74550 11628 90542177
Folliculitis 122.18 9.48 13 74629 204340 90349465
Stress cardiomyopathy 120.87 9.48 95 74547 13260 90540545
Helicobacter infection 120.12 9.48 21 74621 226829 90326976
Anaesthetic complication 118.69 9.48 52 74590 2413 90551392
Insurance issue 114.69 9.48 85 74557 10873 90542932
Bradycardia 111.17 9.48 226 74416 83621 90470184
Rheumatoid factor positive 110.52 9.48 8 74634 171642 90382163
Infusion site extravasation 105.60 9.48 79 74563 10249 90543556
General physical health deterioration 103.97 9.48 84 74558 355031 90198774
Drug intolerance 102.48 9.48 131 74511 447460 90106345
Infusion site erythema 102.19 9.48 87 74555 13583 90540222
Liver injury 101.57 9.48 11 74631 170556 90383249
Infusion site pruritus 100.28 9.48 65 74577 6700 90547105
Pulseless electrical activity 99.62 9.48 72 74570 8860 90544945
Rheumatic fever 98.97 9.48 7 74635 153114 90400691
Muscle injury 98.83 9.48 14 74628 176640 90377165
Impaired healing 94.96 9.48 37 74605 234162 90319643
Psoriatic arthropathy 92.70 9.48 36 74606 228299 90325506
Therapeutic product effect decreased 92.64 9.48 57 74585 277514 90276291
Alopecia 91.17 9.48 168 74474 494903 90058902
Urinary tract infection 88.49 9.48 490 74152 305142 90248663
COVID-19 84.31 9.48 318 74324 168525 90385280
Blister 84.21 9.48 53 74589 254945 90298860
Abdominal discomfort 83.50 9.48 167 74475 477161 90076644
Type 2 diabetes mellitus 80.93 9.48 33 74609 203211 90350594
Seizure 80.84 9.48 293 74349 152336 90401469
Illness 80.53 9.48 196 74446 81773 90472032
Toxicity to various agents 80.34 9.48 457 74185 287389 90266416
Infusion site haemorrhage 77.78 9.48 51 74591 5360 90548445
Sleep disorder due to general medical condition, insomnia type 77.39 9.48 8 74634 128686 90425119
Corneal oedema 75.32 9.48 35 74607 1866 90551939
Infusion site bruising 74.80 9.48 46 74596 4326 90549479
Procedural hypotension 74.60 9.48 33 74609 1567 90552238
Endophthalmitis 71.87 9.48 46 74596 4639 90549166
Mobility decreased 71.26 9.48 61 74581 250673 90303132
Aqueous fibrin 70.19 9.48 17 74625 106 90553699
Product dose omission issue 68.61 9.48 443 74199 291244 90262561
Pulse absent 67.97 9.48 49 74593 6006 90547799
Swollen joint count increased 66.64 9.48 7 74635 111199 90442606
Irritable bowel syndrome 65.92 9.48 45 74597 207403 90346402
Rheumatoid arthritis 65.86 9.48 124 74518 362490 90191315
Anaesthetic complication neurological 64.74 9.48 24 74618 717 90553088
Ill-defined disorder 63.02 9.48 37 74605 184854 90368951
Incorrect drug administration rate 62.62 9.48 44 74598 5179 90548626
Apnoea 62.49 9.48 56 74586 9358 90544447
Seasonal allergy 61.63 9.48 85 74557 22898 90530907
Swelling 61.60 9.48 161 74481 418897 90134908
Lip dry 61.41 9.48 6 74636 100949 90452856
Bronchitis 61.21 9.48 269 74373 152658 90401147
C-reactive protein abnormal 60.82 9.48 15 74627 127414 90426391
Sulphaemoglobinaemia 60.67 9.48 21 74621 512 90553293
Respiratory tract infection 58.80 9.48 142 74500 58936 90494869
Systemic toxicity 56.58 9.48 17 74625 259 90553546
Ventricular tachycardia 55.47 9.48 84 74558 24624 90529181
Musculoskeletal stiffness 55.07 9.48 100 74542 296432 90257373
Emotional distress 54.85 9.48 104 74538 36558 90517247
Infusion site urticaria 54.08 9.48 27 74615 1688 90552117
Product adhesion issue 54.06 9.48 40 74602 5102 90548703
Ventricular fibrillation 53.68 9.48 62 74580 13982 90539823
Upper respiratory tract infection 53.09 9.48 228 74414 128090 90425715
Hypopyon 53.01 9.48 22 74620 892 90552913
Lower respiratory tract infection 52.64 9.48 78 74564 250581 90303224
Staphylococcal infection 52.09 9.48 120 74522 48319 90505486
Unresponsive to stimuli 51.99 9.48 104 74538 38017 90515788
Dermatitis contact 51.94 9.48 60 74582 13535 90540270
Fear 51.53 9.48 66 74576 16556 90537249
Bursitis 51.39 9.48 22 74620 131632 90422173
Type I hypersensitivity 49.81 9.48 35 74607 4120 90549685
Extradural haematoma 49.32 9.48 27 74615 2041 90551764
Extradural abscess 48.55 9.48 23 74619 1281 90552524
Inappropriate schedule of product administration 48.52 9.48 248 74394 149685 90404120
Mental status changes 48.39 9.48 111 74531 44568 90509237
Drug ineffective for unapproved indication 47.91 9.48 142 74500 66502 90487303
Hypersensitivity 46.76 9.48 204 74438 454473 90099332
Stomatitis 46.36 9.48 98 74544 274600 90279205
Completed suicide 45.37 9.48 32 74610 145026 90408779
Gait inability 44.90 9.48 33 74609 146423 90407382
Lagophthalmos 43.87 9.48 16 74626 456 90553349
Anterior chamber cell 43.65 9.48 18 74624 718 90553087
Peripheral nerve injury 43.58 9.48 18 74624 721 90553084
Status epilepticus 43.55 9.48 65 74577 18809 90534996
Blood cholesterol increased 43.40 9.48 65 74577 207947 90345858
Sleep disorder 43.17 9.48 60 74582 197970 90355835
Infusion site mass 42.54 9.48 25 74617 2164 90551641
Ear infection 42.17 9.48 140 74502 69635 90484170
Liver disorder 41.70 9.48 24 74618 121245 90432560
Headache 41.67 9.48 966 73676 861780 89692025
Treatment failure 41.47 9.48 121 74521 303807 90249998
Administration site pain 41.32 9.48 20 74622 1169 90552636
Obesity 40.59 9.48 18 74624 105489 90448316
Premature delivery 40.55 9.48 95 74547 38667 90515138
Bronchospasm 40.38 9.48 66 74576 20643 90533162
Tachycardia 39.21 9.48 243 74399 157430 90396375
Spinal epidural haematoma 39.13 9.48 20 74622 1314 90552491
Embolia cutis medicamentosa 39.06 9.48 16 74626 627 90553178
Spinal epidural haemorrhage 38.73 9.48 13 74629 288 90553517
Kidney infection 38.13 9.48 73 74569 25843 90527962
Abdominal pain upper 38.12 9.48 143 74499 332531 90221274
Renal injury 37.12 9.48 44 74598 10199 90543606
Grip strength decreased 36.88 9.48 15 74627 92561 90461244
Bursitis infective 36.80 9.48 20 74622 1490 90552315
Unevaluable event 36.73 9.48 114 74528 54734 90499071
Respiratory depression 36.46 9.48 54 74588 15521 90538284
Pneumocephalus 36.13 9.48 12 74630 257 90553548
Vitritis 35.55 9.48 20 74622 1594 90552211
Adjustment disorder with depressed mood 35.52 9.48 3 74639 56750 90497055
Inflammation 35.17 9.48 58 74584 178534 90375271
Infusion site discharge 35.12 9.48 23 74619 2412 90551393
Anhedonia 34.82 9.48 45 74597 11386 90542419
Neurotoxicity 34.75 9.48 63 74579 21404 90532401
Multiple allergies 34.72 9.48 52 74590 15094 90538711
Infusion site rash 34.71 9.48 23 74619 2460 90551345
Paraplegia 34.66 9.48 26 74616 3386 90550419
Visual acuity reduced 34.51 9.48 66 74576 23344 90530461
Deep vein thrombosis postoperative 34.44 9.48 8 74634 70801 90483004
Prescribed underdose 33.59 9.48 10 74632 75009 90478796
Vascular malformation 33.43 9.48 15 74627 737 90553068
Cauda equina syndrome 33.02 9.48 18 74624 1349 90552456
Stridor 32.78 9.48 29 74613 4764 90549041
Paranasal cyst 32.36 9.48 15 74627 795 90553010
Sinus tachycardia 32.17 9.48 72 74570 28441 90525364
Fibromyalgia 32.01 9.48 77 74565 206192 90347613
Pulmonary fibrosis 31.95 9.48 25 74617 107478 90446327
Infusion site nodule 31.72 9.48 19 74623 1704 90552101
Circulatory collapse 31.66 9.48 66 74576 24838 90528967
Anal skin tags 31.62 9.48 14 74628 666 90553139
Meningitis chemical 31.26 9.48 11 74631 282 90553523
C-reactive protein increased 31.19 9.48 64 74578 181325 90372480
Infusion related reaction 31.19 9.48 208 74434 416572 90137233
Hypoxia 30.98 9.48 130 74512 72269 90481536
Product use issue 30.94 9.48 153 74489 329766 90224039
Parophthalmia 30.82 9.48 12 74630 411 90553394
Condition aggravated 30.69 9.48 328 74314 595217 89958588
Fear of eating 30.58 9.48 12 74630 420 90553385
Epidural haemorrhage 30.51 9.48 11 74631 303 90553502
Osteoarthritis 30.43 9.48 73 74569 195657 90358148
Trigeminal palsy 30.26 9.48 8 74634 74 90553731
Nail disorder 30.10 9.48 6 74636 59061 90494744
Back pain 30.10 9.48 396 74246 316779 90237026
Drug hypersensitivity 30.06 9.48 241 74401 463368 90090437
Musculoskeletal pain 29.80 9.48 60 74582 171191 90382614
Purtscher retinopathy 29.72 9.48 9 74633 141 90553664
Arthralgia 29.66 9.48 457 74185 778065 89775740
Chills 29.49 9.48 198 74444 131783 90422022
Stress 29.43 9.48 139 74503 81256 90472549
Knee arthroplasty 29.26 9.48 16 74626 83166 90470639
Corneal epithelium defect 29.09 9.48 12 74630 479 90553326
Ophthalmoplegia 28.90 9.48 18 74624 1731 90552074
Administration site swelling 28.82 9.48 17 74625 1482 90552323
Bundle branch block left 28.79 9.48 34 74608 7851 90545954
Prescribed overdose 28.64 9.48 23 74619 97602 90456203
Spinal cord compression 28.31 9.48 27 74615 4884 90548921
Hypercholesterolaemia 28.09 9.48 25 74617 100867 90452938
Cardiogenic shock 27.84 9.48 62 74580 24406 90529399
Confusional state 27.77 9.48 195 74447 386010 90167795
Joint range of motion decreased 27.69 9.48 43 74599 135600 90418205
Platelet aggregation inhibition 27.67 9.48 9 74633 180 90553625
Blepharospasm 27.50 9.48 6 74636 55439 90498366
Incorrect route of product administration 27.47 9.48 98 74544 50528 90503277
Lung disorder 27.40 9.48 51 74591 149832 90403973
Hepatitis 27.32 9.48 12 74630 70727 90483078
Septic arthritis staphylococcal 27.22 9.48 12 74630 565 90553240
Wheezing 26.83 9.48 103 74539 237977 90315828
Eyelid ptosis 26.73 9.48 35 74607 8971 90544834
Localised infection 26.53 9.48 74 74568 33488 90520317
Diplopia 26.43 9.48 67 74575 28647 90525158
Discomfort 26.43 9.48 126 74516 274209 90279596
Hip arthroplasty 26.31 9.48 15 74627 76193 90477612
Myelosuppression 26.17 9.48 6 74636 53585 90500220
Medical device site cellulitis 26.09 9.48 9 74633 217 90553588
Anxiety 25.83 9.48 378 74264 309394 90244411
Retinal vasculitis 25.82 9.48 16 74626 1525 90552280
Body tinea 25.53 9.48 18 74624 2130 90551675
Dry mouth 25.29 9.48 73 74569 183986 90369819
Therapy partial responder 25.24 9.48 56 74586 21987 90531818
Ventricular hypokinesia 24.60 9.48 26 74616 5315 90548490
Epidural analgesia 24.46 9.48 8 74634 163 90553642
Drug-induced liver injury 24.41 9.48 23 74619 90295 90463510
Procedure aborted 24.23 9.48 8 74634 168 90553637
Foetal heart rate abnormal 24.16 9.48 13 74629 949 90552856
Gastroenteritis viral 24.06 9.48 67 74575 30288 90523517
Viral infection 24.05 9.48 82 74560 41332 90512473
Bone erosion 23.86 9.48 7 74635 53014 90500791
Colitis ulcerative 23.63 9.48 10 74632 60256 90493549
Punctate keratitis 23.54 9.48 12 74630 784 90553021
Skin infection 23.48 9.48 48 74594 17816 90535989
Infusion site discomfort 23.42 9.48 16 74626 1800 90552005
Night sweats 23.37 9.48 44 74598 128722 90425083
Upper airway obstruction 23.31 9.48 13 74629 1019 90552786
Infusion site warmth 23.03 9.48 17 74625 2161 90551644
Paralysis 22.95 9.48 37 74605 11441 90542364
Nystagmus 22.88 9.48 29 74613 7198 90546607
Medical device site abscess 22.81 9.48 8 74634 203 90553602
Onychomadesis 22.77 9.48 5 74637 45993 90507812
Neuromuscular block prolonged 22.75 9.48 11 74631 641 90553164
Cataract nuclear 22.60 9.48 13 74629 1081 90552724
Otitis media 22.58 9.48 26 74616 5844 90547961
Nephrolithiasis 22.47 9.48 90 74552 48995 90504810
Psoriasis 22.26 9.48 56 74586 147698 90406107
Mastoiditis 22.22 9.48 15 74627 1655 90552150
Hypoaesthesia oral 21.80 9.48 43 74599 15557 90538248
Poor venous access 21.68 9.48 49 74593 19478 90534327
Vitamin D increased 21.59 9.48 12 74630 934 90552871
Foetal exposure during delivery 21.54 9.48 9 74633 371 90553434
Post procedural complication 21.38 9.48 48 74594 18994 90534811
Nerve root injury 21.36 9.48 6 74636 71 90553734
Red blood cell sedimentation rate increased 21.21 9.48 22 74620 82573 90471232
Meningitis aseptic 21.16 9.48 27 74615 6746 90547059
Hepatic cirrhosis 21.06 9.48 13 74629 63240 90490565
Atonic urinary bladder 21.03 9.48 7 74635 151 90553654
Monoplegia 20.80 9.48 20 74622 3654 90550151
Airway peak pressure increased 20.72 9.48 9 74633 409 90553396
Product distribution issue 20.66 9.48 20 74622 3685 90550120
Hyperthermia malignant 20.55 9.48 13 74629 1285 90552520
Adverse event 20.55 9.48 41 74601 117377 90436428
Wound infection 20.53 9.48 35 74607 106367 90447438
Tinnitus 20.51 9.48 80 74562 43022 90510783
Spinal anaesthesia 20.44 9.48 6 74636 84 90553721
Haemorrhoids 20.25 9.48 58 74584 26644 90527161
Product use in unapproved indication 20.20 9.48 389 74253 335847 90217958
Lupus vulgaris 20.18 9.48 6 74636 45053 90508752
Infusion site discolouration 20.02 9.48 12 74630 1077 90552728
Drug interaction 19.86 9.48 329 74313 276124 90277681
Nerve block 19.82 9.48 11 74631 854 90552951
Blood pressure decreased 19.60 9.48 117 74525 74778 90479027
Loss of personal independence in daily activities 19.42 9.48 53 74589 136052 90417753
Tremor 19.29 9.48 202 74440 152971 90400834
Procedural complication 19.27 9.48 24 74618 5854 90547951
Influenza like illness 19.26 9.48 123 74519 80488 90473317
Vocal cord dysfunction 19.25 9.48 11 74631 903 90552902
Vasoplegia syndrome 19.19 9.48 17 74625 2797 90551008
Arthritis bacterial 19.16 9.48 27 74615 7418 90546387
Tenderness 19.07 9.48 57 74585 26811 90526994
Normal newborn 18.95 9.48 52 74590 23310 90530495
Cardio-respiratory arrest 18.74 9.48 102 74540 63038 90490767
Peripheral swelling 18.72 9.48 234 74408 412872 90140933
Vascular stenosis 18.58 9.48 9 74633 527 90553278
Frequent bowel movements 18.55 9.48 12 74630 56923 90496882
Ophthalmological examination abnormal 18.45 9.48 6 74636 120 90553685
Nail bed tenderness 18.28 9.48 8 74634 370 90553435
Pulmonary oedema 18.23 9.48 100 74542 61980 90491825
Underdose 18.13 9.48 11 74631 54006 90499799
Retinal artery occlusion 18.10 9.48 15 74627 2256 90551549
Retinal haemorrhage 18.04 9.48 23 74619 5741 90548064
Cellulitis 18.04 9.48 133 74509 91204 90462601
Heliotrope rash 18.03 9.48 7 74635 238 90553567
Oropharyngeal pain 18.01 9.48 159 74483 115028 90438777
Cystitis 17.96 9.48 105 74537 66613 90487192
Retinal detachment 17.94 9.48 25 74617 6797 90547008
Transferrin decreased 17.89 9.48 8 74634 390 90553415
Ventricular extrasystoles 17.89 9.48 36 74606 13214 90540591
Gastrointestinal disorder 17.76 9.48 131 74511 256556 90297249
Suspected transmission of an infectious agent via product 17.75 9.48 8 74634 397 90553408
Vision blurred 17.63 9.48 153 74489 110140 90443665
Electrocardiogram ST segment elevation 17.53 9.48 19 74623 3997 90549808
Inhibitory drug interaction 17.49 9.48 17 74625 3146 90550659
Vitreous floaters 17.42 9.48 26 74616 7523 90546282
Left ventricle outflow tract obstruction 17.26 9.48 8 74634 424 90553381
Inadequate analgesia 17.22 9.48 17 74625 3207 90550598
Loss of consciousness 17.21 9.48 184 74458 140054 90413751
Haemodynamic instability 17.19 9.48 33 74609 11706 90542099
Anaphylactoid shock 17.15 9.48 8 74634 430 90553375
Mydriasis 17.04 9.48 38 74604 14974 90538831
Autoimmune disorder 16.97 9.48 23 74619 76721 90477084
Bacterial infection 16.89 9.48 50 74592 23394 90530411
Eye infarction 16.84 9.48 5 74637 73 90553732
Intercepted medication error 16.79 9.48 10 74632 887 90552918
Respiratory distress 16.71 9.48 70 74572 38876 90514929
Iron binding capacity total decreased 16.68 9.48 8 74634 458 90553347
Spinal synovial cyst 16.65 9.48 5 74637 76 90553729
Cyanosis 16.48 9.48 44 74598 19411 90534394
Apgar score low 16.47 9.48 11 74631 1192 90552613
Sensory loss 16.45 9.48 42 74600 18033 90535772
Poikiloderma 16.26 9.48 7 74635 311 90553494
Administration site extravasation 16.25 9.48 11 74631 1219 90552586
Blood pressure abnormal 16.20 9.48 44 74598 19601 90534204
Infection susceptibility increased 16.14 9.48 18 74624 3908 90549897
Nausea 16.07 9.48 1090 73552 1109226 89444579
Brain stem syndrome 16.03 9.48 9 74633 715 90553090
Macular oedema 16.02 9.48 20 74622 4889 90548916
Bulimia nervosa 15.94 9.48 8 74634 506 90553299
Anaphylactoid reaction 15.87 9.48 19 74623 4449 90549356
Cough 15.87 9.48 407 74235 368555 90185250
Sinusitis bacterial 15.83 9.48 13 74629 1930 90551875
Cancer pain 15.77 9.48 18 74624 4007 90549798
Anal sphincter atony 15.75 9.48 7 74635 336 90553469
Apnoeic attack 15.75 9.48 7 74635 336 90553469
Wrong product administered 15.72 9.48 25 74617 7640 90546165
Thrombocytopenia 15.67 9.48 104 74538 208621 90345184
Allergy to immunoglobulin therapy 15.65 9.48 6 74636 197 90553608
Vaginal abscess 15.54 9.48 8 74634 534 90553271
Abortion spontaneous 15.52 9.48 13 74629 54043 90499762
Delayed recovery from anaesthesia 15.52 9.48 10 74632 1020 90552785
Tooth infection 15.48 9.48 44 74598 20126 90533679
Bacterial endophthalmitis 15.42 9.48 6 74636 205 90553600
Limb injury 15.42 9.48 59 74583 31449 90522356
Drug reaction with eosinophilia and systemic symptoms 15.36 9.48 8 74634 42750 90511055
Eyelid contusion 15.24 9.48 5 74637 103 90553702
Streptococcal infection 15.16 9.48 24 74618 7309 90546496
Electrocardiogram QRS complex prolonged 15.12 9.48 24 74618 7324 90546481
Asthenia 15.05 9.48 330 74312 533421 90020384
Weight increased 14.97 9.48 248 74394 417679 90136126
Glucose tolerance impaired 14.96 9.48 25 74617 7960 90545845
Akinesia 14.96 9.48 12 74630 1724 90552081
Infusion site streaking 14.93 9.48 8 74634 579 90553226
Intentional self-injury 14.90 9.48 3 74639 29331 90524474
Orbital infection 14.84 9.48 5 74637 112 90553693
Skin discolouration 14.81 9.48 74 74568 44241 90509564
Infusion site scar 14.70 9.48 8 74634 598 90553207
Quadriparesis 14.66 9.48 14 74628 2535 90551270
Procedural anxiety 14.63 9.48 9 74633 847 90552958
Peripheral vascular disorder 14.63 9.48 22 74620 6409 90547396
Nail bed inflammation 14.57 9.48 12 74630 1789 90552016
Body dysmorphic disorder 14.54 9.48 7 74635 404 90553401
Productive cough 14.53 9.48 111 74531 76952 90476853
Influenza 14.52 9.48 177 74465 139087 90414718
Hepatotoxicity 14.48 9.48 10 74632 45832 90507973
Obstruction 14.47 9.48 17 74625 3904 90549901
Anorectal discomfort 14.38 9.48 15 74627 3019 90550786
C-reactive protein 14.38 9.48 4 74638 31363 90522442
Therapeutic product effect incomplete 14.36 9.48 97 74545 193799 90360006
Implant site bruising 14.30 9.48 7 74635 419 90553386
Infusion site oedema 14.28 9.48 10 74632 1171 90552634
Lethargy 14.26 9.48 95 74547 63044 90490761
Neonatal toxicity 14.19 9.48 4 74638 48 90553757
Administration site erythema 14.13 9.48 9 74633 900 90552905
Epilepsy 14.13 9.48 29 74613 82177 90471628
Axillary nerve injury 14.12 9.48 4 74638 49 90553756
Retinitis 14.11 9.48 7 74635 38451 90515354
Anterior chamber fibrin 14.11 9.48 5 74637 131 90553674
Calcinosis 14.01 9.48 14 74628 2681 90551124
Tachypnoea 14.00 9.48 44 74598 21265 90532540
Product preparation error 14.00 9.48 28 74614 10233 90543572
Memory impairment 13.96 9.48 100 74542 197144 90356661
Gastric mucosa erythema 13.88 9.48 7 74635 447 90553358
Vascular resistance systemic decreased 13.86 9.48 5 74637 138 90553667
Neuralgia 13.82 9.48 57 74585 31443 90522362
Cholestasis of pregnancy 13.80 9.48 11 74631 1566 90552239
Rash 13.66 9.48 527 74115 795573 89758232
Back injury 13.65 9.48 11 74631 46611 90507194
Conjunctival oedema 13.60 9.48 9 74633 960 90552845
Economic problem 13.41 9.48 15 74627 3266 90550539
Labelled drug-drug interaction medication error 13.40 9.48 34 74608 14548 90539257
Orthostatic hypotension 13.37 9.48 9 74633 41818 90511987
Spinal stroke 13.31 9.48 4 74638 61 90553744
Sepsis 13.27 9.48 215 74427 179599 90374206
Eclampsia 13.27 9.48 7 74635 491 90553314
Acute respiratory failure 13.18 9.48 70 74572 42848 90510957
Metapneumovirus infection 13.18 9.48 10 74632 1325 90552480
Pneumonia mycoplasmal 13.17 9.48 9 74633 1013 90552792
Pancreatitis acute 13.12 9.48 5 74637 32110 90521695
Infusion site irritation 13.06 9.48 10 74632 1343 90552462
Incontinence 13.05 9.48 32 74610 13403 90540402
Allergy to metals 13.03 9.48 9 74633 1031 90552774
Intraocular pressure increased 13.02 9.48 22 74620 7071 90546734
Lower limb fracture 12.97 9.48 32 74610 84981 90468824
Arthritis fungal 12.96 9.48 4 74638 67 90553738
Somnolence 12.92 9.48 243 74399 208841 90344964
Agitation 12.85 9.48 97 74545 67001 90486804
Drug level increased 12.78 9.48 51 74591 27711 90526094
Genital ulceration 12.77 9.48 9 74633 1064 90552741
Intraocular pressure fluctuation 12.64 9.48 4 74638 73 90553732
Autonomic neuropathy 12.59 9.48 10 74632 1417 90552388
Sinus disorder 12.58 9.48 59 74583 34388 90519417
Haemangioma congenital 12.55 9.48 7 74635 549 90553256
Trigemino-cardiac reflex 12.54 9.48 4 74638 75 90553730
Spinal cord injury 12.50 9.48 9 74633 1100 90552705
Phrenic nerve paralysis 12.50 9.48 6 74636 344 90553461
Coeliac disease 12.48 9.48 11 74631 44599 90509206
Fear-related avoidance of activities 12.45 9.48 5 74637 186 90553619
Tryptase increased 12.42 9.48 7 74635 560 90553245
Implant site swelling 12.36 9.48 7 74635 565 90553240
Quadriplegia 12.36 9.48 12 74630 2219 90551586
Papule 12.34 9.48 23 74619 7979 90545826
Diplegia 12.30 9.48 10 74632 1465 90552340
Injection site atrophy 12.24 9.48 8 74634 836 90552969
Nasal mucosal disorder 12.23 9.48 11 74631 1846 90551959
Overdose 12.18 9.48 190 74452 157519 90396286
Renal failure 12.17 9.48 163 74479 130844 90422961
Pharyngitis streptococcal 12.01 9.48 30 74612 12712 90541093
Cardiotoxicity 12.00 9.48 28 74614 11361 90542444
Product contamination 11.98 9.48 9 74633 1175 90552630
Proctalgia 11.94 9.48 23 74619 8175 90545630
Accelerated idioventricular rhythm 11.94 9.48 4 74638 88 90553717
Retinal disorder 11.92 9.48 11 74631 1908 90551897
Poor quality sleep 11.89 9.48 46 74596 24647 90529158
Heparin-induced thrombocytopenia 11.84 9.48 18 74624 5294 90548511
Repetitive strain injury 11.84 9.48 5 74637 212 90553593
Mean arterial pressure decreased 11.81 9.48 5 74637 213 90553592
Erythema 11.71 9.48 259 74383 228987 90324818
Immunodeficiency 11.69 9.48 11 74631 43223 90510582
Retinal cyst 11.58 9.48 4 74638 97 90553708
Multiple organ dysfunction syndrome 11.55 9.48 96 74546 68240 90485565
Hordeolum 11.54 9.48 17 74625 4861 90548944
Post procedural infection 11.43 9.48 27 74615 11047 90542758
Application site alopecia 11.42 9.48 3 74639 27 90553778
Infusion related hypersensitivity reaction 11.41 9.48 7 74635 655 90553150
Concussion 11.40 9.48 27 74615 11064 90542741
Meningitis 11.40 9.48 23 74619 8458 90545347
Product administration interrupted 11.34 9.48 29 74613 12463 90541342
Central pain syndrome 11.34 9.48 7 74635 663 90553142
Haemorrhagic vasculitis 11.28 9.48 4 74638 105 90553700
White blood cell disorder 11.18 9.48 13 74629 2951 90550854
Hallucination, tactile 11.18 9.48 6 74636 436 90553369
Corneal abrasion 11.14 9.48 9 74633 1307 90552498
Vasospasm 11.09 9.48 8 74634 981 90552824
Anorgasmia 11.05 9.48 7 74635 693 90553112
Impaired quality of life 11.05 9.48 43 74599 23101 90530704
Suicide attempt 11.03 9.48 29 74613 75370 90478435
Pupil fixed 10.96 9.48 11 74631 2117 90551688
Cerebral congestion 10.93 9.48 4 74638 115 90553690
Angioedema 10.89 9.48 91 74551 64785 90489020
Sympathectomy 10.88 9.48 3 74639 33 90553772
Coccygectomy 10.88 9.48 3 74639 33 90553772
Haematocrit increased 10.79 9.48 13 74629 3065 90550740
Body temperature abnormal 10.77 9.48 12 74630 2603 90551202
Onychomycosis 10.72 9.48 9 74633 37367 90516438
Interstitial lung disease 10.71 9.48 30 74612 76375 90477430
Cardiac dysfunction 10.71 9.48 14 74628 3583 90550222
Liver function test increased 10.69 9.48 35 74607 84820 90468985
Renal cyst 10.68 9.48 29 74613 12921 90540884
Inability to afford medication 10.63 9.48 14 74628 3608 90550197
Device infusion issue 10.59 9.48 12 74630 2650 90551155
Incision site swelling 10.55 9.48 5 74637 279 90553526
Speech disorder 10.54 9.48 69 74573 45516 90508289
Product contamination microbial 10.51 9.48 5 74637 281 90553524
Ischaemia 10.49 9.48 17 74625 5278 90548527
Liver function test abnormal 10.49 9.48 16 74626 50829 90502976
Electrocardiogram T wave inversion 10.45 9.48 14 74628 3669 90550136
Leukopenia 10.44 9.48 45 74597 100665 90453140
Incision site rash 10.42 9.48 3 74639 39 90553766
Injection site abscess 10.35 9.48 9 74633 1445 90552360
Metamorphopsia 10.34 9.48 9 74633 1448 90552357
Taste disorder 10.33 9.48 22 74620 61524 90492281
Spinal osteoarthritis 10.33 9.48 37 74605 19111 90534694
Chemical burn 10.32 9.48 6 74636 509 90553296
Depression 10.23 9.48 180 74462 300421 90253384
Immune thrombocytopenia 10.16 9.48 29 74613 13297 90540508
Allergic cough 10.15 9.48 8 74634 1120 90552685
Neurogenic shock 10.10 9.48 6 74636 530 90553275
Sciatica 10.08 9.48 46 74596 101336 90452469
Respiratory failure 10.05 9.48 145 74497 118273 90435532
Myelitis transverse 10.01 9.48 9 74633 1511 90552294
Muscle tightness 10.00 9.48 29 74613 13410 90540395
Encephalopathy 9.96 9.48 69 74573 46375 90507430
Vitreous detachment 9.94 9.48 11 74631 2367 90551438
Syncope 9.93 9.48 159 74483 132504 90421301
Fanconi syndrome 9.93 9.48 10 74632 1933 90551872
Retrograde amnesia 9.92 9.48 6 74636 548 90553257
Presyncope 9.86 9.48 52 74590 31753 90522052
Anaesthetic complication cardiac 9.85 9.48 3 74639 48 90553757
Infusion site induration 9.81 9.48 9 74633 1550 90552255
Eye movement disorder 9.79 9.48 18 74624 6180 90547625
Small intestinal obstruction 9.77 9.48 39 74603 21195 90532610
Clostridium difficile infection 9.73 9.48 57 74585 36188 90517617
Rotator cuff syndrome 9.67 9.48 32 74610 15887 90537918
Osteomyelitis 9.66 9.48 47 74595 27799 90526006
Laryngeal oedema 9.65 9.48 19 74623 6862 90546943
Miosis 9.65 9.48 23 74619 9461 90544344
Walking aid user 9.64 9.48 9 74633 35497 90518308
Femoral nerve injury 9.63 9.48 3 74639 52 90553753
Spinal operation 9.60 9.48 24 74618 10172 90543633
Physical disability 9.60 9.48 14 74628 3967 90549838
Administration site reaction 9.56 9.48 5 74637 345 90553460
Myocardial ischaemia 9.51 9.48 29 74613 13785 90540020
Visual acuity tests abnormal 9.50 9.48 4 74638 168 90553637
Orbital oedema 9.50 9.48 5 74637 349 90553456
Steroid diabetes 9.49 9.48 11 74631 2491 90551314

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
Local anaesthetic systemic toxicity 532.54 11.29 163 42879 2137 42576156
Anaphylactic shock 243.88 11.29 197 42845 23320 42554973
Anaphylactic reaction 218.81 11.29 242 42800 42501 42535792
Methaemoglobinaemia 198.71 11.29 103 42939 5671 42572622
Inspiratory capacity decreased 179.29 11.29 78 42964 2889 42575404
Cardiac arrest 147.85 11.29 335 42707 108985 42469308
Anaesthetic complication 127.79 11.29 50 42992 1407 42576886
Toxic anterior segment syndrome 125.63 11.29 49 42993 1367 42576926
Toxicity to various agents 112.85 11.29 494 42548 228642 42349651
Hypotension 105.28 11.29 526 42516 257105 42321188
Ventricular tachycardia 99.59 11.29 137 42905 30023 42548270
Drug ineffective 92.66 11.29 1006 42036 629191 41949102
Injury 88.61 11.29 111 42931 22205 42556088
Ventricular fibrillation 87.90 11.29 129 42913 29994 42548299
Bradycardia 83.93 11.29 232 42810 85252 42493041
Fear 83.45 11.29 77 42965 10888 42567405
Generalised tonic-clonic seizure 78.46 11.29 114 42928 26265 42552028
Emotional distress 73.60 11.29 86 42956 16007 42562286
Anhedonia 72.88 11.29 61 42981 7579 42570714
Renal injury 70.63 11.29 74 42968 12206 42566087
Unresponsive to stimuli 63.65 11.29 114 42928 31289 42547004
Sinusitis 62.79 11.29 144 42898 47148 42531145
Electrocardiogram ST segment elevation 59.94 11.29 49 42993 5890 42572403
Drug ineffective for unapproved indication 53.14 11.29 133 42909 46030 42532263
Tachycardia 51.94 11.29 221 42821 100866 42477427
Overdose 48.68 11.29 223 42819 105041 42473252
Infusion site extravasation 48.67 11.29 42 43000 5439 42572854
Stress 47.38 11.29 124 42918 44088 42534205
Anal inflammation 47.38 11.29 29 43013 2200 42576093
Infusion site pain 45.21 11.29 40 43002 5355 42572938
Incorrect route of product administration 43.93 11.29 84 42958 24221 42554072
Hyperthermia malignant 42.71 11.29 29 43013 2629 42575664
Adulterated product 42.60 11.29 19 43023 747 42577546
Cardiogenic shock 42.40 11.29 104 42938 35536 42542757
Insurance issue 41.62 11.29 34 43008 4082 42574211
Pain 41.41 11.29 403 42639 244445 42333848
Accident 40.67 11.29 41 43001 6462 42571831
SARS-CoV-2 test negative 40.07 11.29 24 43018 1751 42576542
Endophthalmitis 39.42 11.29 34 43008 4399 42573894
Unevaluable event 38.63 11.29 98 42944 34190 42544103
Interstitial lung disease 37.69 11.29 16 43026 78446 42499847
Trigemino-cardiac reflex 37.07 11.29 14 43028 357 42577936
Sinus tachycardia 36.86 11.29 71 42971 20582 42557711
Ear infection 36.14 11.29 54 42988 12750 42565543
Status epilepticus 36.07 11.29 60 42982 15518 42562775
Neurotoxicity 35.89 11.29 76 42966 23575 42554718
Diarrhoea 35.78 11.29 296 42746 460553 42117740
Spinal cord infarction 35.38 11.29 16 43026 650 42577643
Electrocardiogram QRS complex prolonged 35.12 11.29 36 43006 5787 42572506
Infusion site erythema 34.71 11.29 29 43013 3593 42574700
Hypoxia 34.62 11.29 151 42891 69635 42508658
Haemodynamic instability 32.68 11.29 51 42991 12506 42565787
Cauda equina syndrome 32.33 11.29 17 43025 963 42577330
Mydriasis 32.24 11.29 42 43000 8728 42569565
Acute kidney injury 32.22 11.29 228 42814 367109 42211184
Proctalgia 30.93 11.29 37 43005 7056 42571237
Anaesthetic complication neurological 30.82 11.29 15 43027 721 42577572
Oculocardiac reflex 29.53 11.29 9 43033 116 42578177
Seizure 29.11 11.29 215 42827 120346 42457947
Bronchospasm 29.00 11.29 49 42993 12836 42565457
Respiratory tract infection bacterial 28.72 11.29 20 43022 1889 42576404
Tracheitis 28.64 11.29 16 43026 1023 42577270
Aqueous fibrin 28.36 11.29 8 43034 77 42578216
Respiratory depression 27.90 11.29 60 42982 18808 42559485
Corneal oedema 27.55 11.29 18 43024 1530 42576763
Blood phosphorus increased 27.36 11.29 47 42995 12478 42565815
Respiratory tract infection 27.35 11.29 73 42969 26249 42552044
Negative pressure pulmonary oedema 26.96 11.29 13 43029 612 42577681
Accidental overdose 26.89 11.29 76 42966 28254 42550039
Apnoea 26.58 11.29 36 43006 7767 42570526
Brain oedema 26.57 11.29 54 42988 16273 42562020
Kounis syndrome 26.30 11.29 24 43018 3344 42574949
Hyperphosphataemia 26.07 11.29 47 42995 12957 42565336
Hypopyon 25.75 11.29 12 43030 523 42577770
Decreased appetite 25.12 11.29 105 42937 193032 42385261
Circulatory collapse 25.02 11.29 66 42976 23570 42554723
Appendicolith 24.92 11.29 47 42995 13409 42564884
Vasoplegia syndrome 24.91 11.29 21 43021 2634 42575659
Weight decreased 24.66 11.29 117 42925 207831 42370462
Disease progression 24.13 11.29 70 42972 143586 42434707
Neuralgia 23.56 11.29 68 42974 25579 42552714
Product adhesion issue 23.35 11.29 17 43025 1722 42576571
Brain stem syndrome 23.07 11.29 12 43030 665 42577628
Infusion site swelling 22.90 11.29 22 43020 3270 42575023
Drug therapy 22.60 11.29 30 43012 6350 42571943
Diabetes insipidus 22.47 11.29 23 43019 3690 42574603
Loss of consciousness 22.46 11.29 165 42877 92189 42486104
Myasthenia gravis 22.36 11.29 50 42992 16087 42562206
Respiratory tract infection viral 22.27 11.29 22 43020 3384 42574909
Type I hypersensitivity 22.13 11.29 18 43024 2148 42576145
Analgesic therapy 22.07 11.29 30 43012 6494 42571799
Macular ischaemia 22.04 11.29 8 43034 182 42578111
Tubulointerstitial nephritis 21.78 11.29 3 43039 31545 42546748
Retinal artery occlusion 21.78 11.29 18 43024 2197 42576096
Psoriasis 21.65 11.29 11 43031 48593 42529700
Myelosuppression 21.52 11.29 7 43035 40454 42537839
Postoperative delirium 21.50 11.29 11 43031 589 42577704
Intracranial hypotension 21.35 11.29 10 43032 441 42577852
Sleep disorder therapy 20.79 11.29 30 43012 6864 42571429
Neuromuscular blockade 20.47 11.29 9 43033 342 42577951
Chemical burn 20.42 11.29 9 43033 344 42577949
Lagophthalmos 20.41 11.29 7 43035 134 42578159
Embolia cutis medicamentosa 20.39 11.29 9 43033 345 42577948
Ventricular extrasystoles 20.28 11.29 43 42999 13347 42564946
Respiratory arrest 20.24 11.29 69 42973 28355 42549938
Cytomegalovirus infection 20.24 11.29 4 43038 32302 42545991
Seizure like phenomena 20.12 11.29 13 43029 1084 42577209
Blindness 19.84 11.29 51 42991 17927 42560366
Leukopenia 19.74 11.29 28 43014 74718 42503575
Myoclonus 19.45 11.29 49 42993 17016 42561277
Paraesthesia oral 19.41 11.29 25 43017 5138 42573155
Anxiety 18.94 11.29 193 42849 118367 42459926
Corneal epithelium defect 18.88 11.29 9 43033 413 42577880
Mental status changes 18.54 11.29 88 42954 42027 42536266
Iron deficiency 18.49 11.29 37 43005 11024 42567269
Reperfusion arrhythmia 18.43 11.29 6 43036 97 42578196
Vitreous floaters 18.33 11.29 22 43020 4208 42574085
Rheumatoid arthritis 18.32 11.29 10 43032 42430 42535863
Myocardial infarction 18.31 11.29 64 42978 123945 42454348
Thyrotoxic crisis 18.11 11.29 11 43031 823 42577470
Spinal meningeal cyst 18.10 11.29 6 43036 103 42578190
Hyperaesthesia 18.09 11.29 26 43016 5926 42572367
Multiple organ dysfunction syndrome 17.99 11.29 163 42879 96872 42481421
Febrile neutropenia 17.90 11.29 275 42767 185428 42392865
Administration site pain 17.89 11.29 9 43033 465 42577828
Hypophosphataemia 17.78 11.29 54 42988 20891 42557402
Tryptase increased 17.76 11.29 8 43034 322 42577971
Corneal opacity 17.68 11.29 10 43032 655 42577638
Behaviour disorder 17.46 11.29 28 43014 7026 42571267
Haematochezia 17.39 11.29 20 43022 58416 42519877
Prostate cancer 17.21 11.29 12 43030 44631 42533662
Wrong product administered 17.20 11.29 26 43016 6200 42572093
Laryngospasm 17.18 11.29 15 43027 1973 42576320
Suicide attempt 16.98 11.29 13 43029 46087 42532206
Melaena 16.91 11.29 9 43033 38737 42539556
Body temperature increased 16.82 11.29 52 42990 20306 42557987
Infusion site bruising 16.77 11.29 11 43031 941 42577352
Enterobacter pneumonia 16.46 11.29 9 43033 552 42577741
Appendicitis 16.43 11.29 52 42990 20561 42557732
Cardiotoxicity 16.34 11.29 28 43014 7417 42570876
Post procedural complication 16.33 11.29 38 43004 12552 42565741
Vitritis 16.30 11.29 12 43030 1237 42577056
White blood cell count decreased 16.28 11.29 57 42985 110339 42467954
General physical health deterioration 16.27 11.29 88 42954 151158 42427135
Hypoxic-ischaemic encephalopathy 16.22 11.29 23 43019 5179 42573114
Catecholamine crisis 16.03 11.29 5 43037 70 42578223
Torsade de pointes 15.89 11.29 30 43012 8564 42569729
Swelling 15.66 11.29 102 42940 54783 42523510
Bacteroides infection 15.61 11.29 16 43026 2571 42575722
Anal sphincter atony 15.56 11.29 6 43036 162 42578131
Vitreous disorder 15.50 11.29 6 43036 164 42578129
Ventricular asystole 15.28 11.29 7 43035 293 42578000
Corneal infiltrates 15.26 11.29 6 43036 171 42578122
Haemoglobin decreased 14.84 11.29 76 42966 132395 42445898
Delayed recovery from anaesthesia 14.73 11.29 11 43031 1158 42577135
Therapy non-responder 14.52 11.29 98 42944 53261 42525032
Procedural pain 14.38 11.29 23 43019 5756 42572537
Pancreatitis acute 14.35 11.29 8 43034 33556 42544737
Electrocardiogram T wave amplitude increased 14.28 11.29 5 43037 102 42578191
Phaeochromocytoma crisis 14.19 11.29 5 43037 104 42578189
Pulse absent 14.16 11.29 24 43018 6303 42571990
Cardiac failure congestive 14.15 11.29 42 43000 85560 42492733
Blood uric acid increased 14.06 11.29 41 43001 15506 42562787
Pneumocystis jirovecii pneumonia 14.04 11.29 4 43038 25177 42553116
Hepatic function abnormal 13.93 11.29 19 43023 51548 42526745
Procedural hypotension 13.91 11.29 10 43032 993 42577300
Myalgia 13.91 11.29 50 42992 96030 42482263
Abdominal discomfort 13.88 11.29 35 43007 75220 42503073
Drug-induced liver injury 13.84 11.29 11 43031 38262 42540031
Vitreous detachment 13.80 11.29 10 43032 1006 42577287
Postictal state 13.76 11.29 10 43032 1010 42577283
Diabetic retinal oedema 13.69 11.29 6 43036 226 42578067
Mean arterial pressure decreased 13.67 11.29 6 43036 227 42578066
Myokymia 13.64 11.29 5 43037 117 42578176
Chills 13.55 11.29 150 42892 93916 42484377
Diabetic ketoacidosis 13.54 11.29 3 43039 22364 42555929
Haemorrhoids 13.51 11.29 43 42999 17054 42561239
Encephalomalacia 13.41 11.29 10 43032 1051 42577242
Treatment noncompliance 13.40 11.29 11 43031 37661 42540632
Hypoaesthesia oral 13.28 11.29 20 43022 4753 42573540
Weight increased 13.23 11.29 60 42982 107923 42470370
Oesophageal obstruction 13.23 11.29 8 43034 594 42577699
Asthenia 13.13 11.29 202 42840 280591 42297702
Asthma 13.10 11.29 27 43015 62287 42516006
Anaemia 12.98 11.29 202 42840 280076 42298217
Ventricular arrhythmia 12.98 11.29 23 43019 6256 42572037
Total lung capacity decreased 12.97 11.29 17 43025 3553 42574740
Blindness transient 12.91 11.29 15 43027 2774 42575519
Visual acuity reduced 12.84 11.29 43 42999 17507 42560786
Brain hypoxia 12.81 11.29 8 43034 629 42577664
Eye inflammation 12.76 11.29 16 43026 3202 42575091
Frequent bowel movements 12.70 11.29 3 43039 21404 42556889
Mean arterial pressure increased 12.57 11.29 4 43038 60 42578233
Infusion site pruritus 12.52 11.29 10 43032 1163 42577130
Retinal vasculitis 12.52 11.29 8 43034 655 42577638
Hepatitis 12.43 11.29 6 43036 27294 42550999
Upper respiratory tract infection 12.42 11.29 79 42963 42094 42536199
Illness 12.39 11.29 54 42988 24876 42553417
Anterior chamber cell 12.34 11.29 7 43035 461 42577832
Kidney congestion 12.27 11.29 7 43035 466 42577827
Malignant neoplasm progression 12.25 11.29 62 42980 108338 42469955
Shock 12.20 11.29 60 42982 29061 42549232
Ophthalmoplegia 12.19 11.29 13 43029 2187 42576106
Posterior capsule opacification 12.06 11.29 5 43037 164 42578129
Aortic stenosis 12.01 11.29 27 43015 8718 42569575
Post herpetic neuralgia 11.99 11.29 10 43032 1236 42577057
Retinal degeneration 11.98 11.29 8 43034 705 42577588
Retinal oedema 11.96 11.29 9 43033 959 42577334
Pulmonary fibrosis 11.94 11.29 6 43036 26675 42551618
Thrombocytopenia 11.80 11.29 129 42913 190150 42388143
Macroglossia 11.76 11.29 7 43035 505 42577788
Miosis 11.72 11.29 35 43007 13411 42564882
Accidental death 11.70 11.29 15 43027 3068 42575225
Product contamination microbial 11.62 11.29 8 43034 742 42577551
Respiratory acidosis 11.58 11.29 22 43020 6309 42571984
Completed suicide 11.58 11.29 54 42988 96411 42481882
Lung opacity 11.58 11.29 21 43021 5816 42572477
Retinal toxicity 11.57 11.29 7 43035 520 42577773
Open globe injury 11.55 11.29 4 43038 79 42578214
Myotonic dystrophy 11.55 11.29 5 43037 183 42578110
Pulseless electrical activity 11.53 11.29 26 43016 8411 42569882
Coronary artery disease 11.53 11.29 23 43019 53697 42524596
Prostate infection 11.53 11.29 10 43032 1304 42576989
Blood pressure systolic increased 11.48 11.29 7 43035 27961 42550332
Cerebral venous thrombosis 11.38 11.29 9 43033 1032 42577261
Anaesthetic complication pulmonary 11.36 11.29 4 43038 83 42578210
Disability 11.33 11.29 21 43021 5912 42572381

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
Local anaesthetic systemic toxicity 1383.66 9.60 402 95457 5135 110488305
Anaphylactic shock 515.54 9.60 397 95462 51149 110442291
Anaphylactic reaction 515.36 9.60 563 95296 113737 110379703
Cardiac arrest 432.41 9.60 680 95179 196073 110297367
Toxic anterior segment syndrome 412.97 9.60 143 95716 3311 110490129
Maternal exposure during delivery 296.86 9.60 113 95746 3452 110489988
Methaemoglobinaemia 295.80 9.60 149 95710 9019 110484421
Hypotension 260.43 9.60 1019 94840 522830 109970610
Anaesthetic complication 235.94 9.60 96 95763 3510 110489930
Toxicity to various agents 208.81 9.60 897 94962 479658 110013782
Generalised tonic-clonic seizure 198.52 9.60 241 95618 54439 110439001
Bradycardia 193.68 9.60 421 95438 155096 110338344
Synovitis 193.05 9.60 11 95848 274081 110219359
Kounis syndrome 175.77 9.60 91 95768 5834 110487606
Inspiratory capacity decreased 162.67 9.60 67 95792 2528 110490912
Hand deformity 159.49 9.60 7 95852 218499 110274941
Systemic lupus erythematosus 147.96 9.60 22 95837 254316 110239124
Ventricular tachycardia 146.24 9.60 198 95661 49811 110443629
Ventricular fibrillation 144.96 9.60 179 95680 41134 110452306
Hepatic enzyme increased 139.22 9.60 52 95807 320840 110172600
Fear 136.58 9.60 132 95727 23061 110470379
Pemphigus 135.93 9.60 14 95845 214556 110278884
Joint swelling 135.53 9.60 111 95748 442734 110050706
Pericarditis 134.50 9.60 16 95843 219098 110274342
Anti-cyclic citrullinated peptide antibody positive 132.25 9.60 6 95853 181978 110311462
Duodenal ulcer perforation 128.67 9.60 6 95853 177694 110315746
Glossodynia 127.31 9.60 20 95839 221984 110271456
Unresponsive to stimuli 124.32 9.60 209 95650 63581 110429859
Emotional distress 119.80 9.60 170 95689 44677 110448763
Contraindicated product administered 118.63 9.60 34 95825 248233 110245207
Stress cardiomyopathy 118.52 9.60 103 95756 15703 110477737
Seizure 117.56 9.60 440 95419 220745 110272695
Renal injury 113.02 9.60 108 95751 18605 110474835
Anaesthetic complication neurological 109.09 9.60 39 95820 994 110492446
Arthropathy 106.86 9.60 58 95801 287464 110205976
Drug ineffective for unapproved indication 105.48 9.60 258 95601 102580 110390860
General physical health deterioration 104.49 9.60 129 95730 425166 110068274
Anhedonia 102.71 9.60 94 95765 15334 110478106
Pulseless electrical activity 101.75 9.60 97 95762 16660 110476780
Folliculitis 101.03 9.60 13 95846 167640 110325800
Endophthalmitis 99.64 9.60 71 95788 8116 110485324
Type 2 diabetes mellitus 95.01 9.60 19 95840 177213 110316227
Aqueous fibrin 92.90 9.60 24 95835 190 110493250
Mobility decreased 92.52 9.60 45 95814 237377 110256063
Corneal oedema 89.17 9.60 47 95812 3126 110490314
Tachycardia 89.08 9.60 411 95448 226234 110267206
Unevaluable event 88.59 9.60 173 95686 59054 110434386
Rheumatoid factor positive 87.63 9.60 7 95852 131633 110361807
Status epilepticus 86.28 9.60 121 95738 31450 110461990
Psoriatic arthropathy 85.11 9.60 32 95827 196729 110296711
Muscle injury 84.64 9.60 11 95848 140796 110352644
Procedural hypotension 84.60 9.60 42 95817 2463 110490977
Insurance issue 83.32 9.60 71 95788 10541 110482899
Wound 83.22 9.60 50 95809 234387 110259053
Rheumatic fever 83.06 9.60 6 95853 122573 110370867
Liver injury 80.88 9.60 16 95843 150397 110343043
Cardiogenic shock 78.00 9.60 161 95698 57177 110436263
Abdominal discomfort 77.71 9.60 139 95720 393719 110099721
Apnoea 77.26 9.60 76 95783 13563 110479877
Sinus tachycardia 76.55 9.60 138 95721 44355 110449085
Drug ineffective 75.55 9.60 1785 94074 1518755 108974685
Rheumatoid arthritis 73.42 9.60 91 95768 299522 110193918
Bronchospasm 72.59 9.60 109 95750 30130 110463310
Incorrect route of product administration 72.48 9.60 167 95692 63894 110429546
Pulse absent 71.68 9.60 67 95792 11225 110482215
Therapeutic product effect decreased 71.30 9.60 64 95795 244252 110249188
Facet joint syndrome 70.97 9.60 3 95856 96825 110396615
Impaired healing 69.75 9.60 42 95817 196675 110296765
Product adhesion issue 69.14 9.60 39 95820 2967 110490473
Mental status changes 68.71 9.60 182 95677 75940 110417500
Neurotoxicity 67.69 9.60 127 95732 42080 110451360
Stress 64.85 9.60 220 95639 105128 110388312
Cauda equina syndrome 64.12 9.60 33 95826 2089 110491351
C-reactive protein abnormal 63.35 9.60 17 95842 129678 110363762
Type I hypersensitivity 63.35 9.60 49 95810 6344 110487096
Irritable bowel syndrome 62.65 9.60 32 95827 164183 110329257
Hyperthermia malignant 62.22 9.60 40 95819 3860 110489580
Infusion related reaction 62.12 9.60 150 95709 381012 110112428
Lagophthalmos 61.49 9.60 22 95837 562 110492878
Alopecia 61.47 9.60 141 95718 364612 110128828
Hypoxia 60.92 9.60 248 95611 129267 110364173
Infusion site pain 60.33 9.60 75 95784 17344 110476096
Myelosuppression 60.13 9.60 6 95853 94334 110399106
Lip dry 59.72 9.60 8 95851 100075 110393365
Sleep disorder due to general medical condition, insomnia type 59.46 9.60 10 95849 105633 110387807
Bursitis 58.09 9.60 20 95839 129898 110363542
Overdose 57.98 9.60 374 95485 233420 110260020
Embolia cutis medicamentosa 57.45 9.60 24 95835 939 110492501
Sulphaemoglobinaemia 57.36 9.60 21 95838 574 110492866
Peripheral venous disease 57.33 9.60 4 95855 84113 110409327
Respiratory depression 57.29 9.60 101 95758 31900 110461540
Hypopyon 57.25 9.60 27 95832 1413 110492027
Drug intolerance 56.47 9.60 173 95686 406339 110087101
Electrocardiogram ST segment elevation 55.57 9.60 53 95806 9107 110484333
Anterior chamber cell 55.12 9.60 25 95834 1196 110492244
Hypercholesterolaemia 54.82 9.60 7 95852 90830 110402610
Infusion site bruising 54.32 9.60 36 95823 3658 110489782
Haemodynamic instability 54.22 9.60 82 95777 22806 110470634
Circulatory collapse 54.16 9.60 117 95742 42876 110450564
Infusion site swelling 54.03 9.60 54 95805 9823 110483617
Ill-defined disorder 53.52 9.60 35 95824 156818 110336622
Obesity 53.25 9.60 16 95843 113335 110380105
Arthralgia 52.16 9.60 429 95430 779203 109714237
Swollen joint count increased 51.59 9.60 6 95853 83655 110409785
Extradural abscess 51.19 9.60 28 95831 2006 110491434
Musculoskeletal stiffness 50.58 9.60 104 95755 279718 110213722
Trigemino-cardiac reflex 50.56 9.60 18 95841 453 110492987
Infusion site erythema 50.54 9.60 57 95802 11902 110481538
Extradural haematoma 49.95 9.60 33 95826 3336 110490104
Dermatitis contact 49.81 9.60 61 95798 13892 110479548
Blister 49.71 9.60 75 95784 227301 110266139
Illness 49.17 9.60 170 95689 82001 110411439
Premature delivery 48.90 9.60 92 95767 30540 110462900
Corneal epithelium defect 48.66 9.60 21 95838 891 110492549
Loss of consciousness 48.64 9.60 314 95545 195992 110297448
Anal inflammation 48.44 9.60 29 95830 2467 110490973
Completed suicide 48.26 9.60 85 95774 242296 110251144
Electrocardiogram QRS complex prolonged 48.23 9.60 58 95801 12963 110480477
Systemic toxicity 47.22 9.60 16 95843 346 110493094
Liver disorder 46.84 9.60 33 95826 142210 110351230
Vitritis 46.81 9.60 29 95830 2624 110490816
Infusion site extravasation 46.71 9.60 54 95805 11580 110481860
Abdominal pain upper 46.07 9.60 152 95707 348959 110144481
Osteoarthritis 45.21 9.60 55 95804 182568 110310872
Spinal cord infarction 44.93 9.60 21 95838 1077 110492363
Infusion site pruritus 44.50 9.60 36 95823 4972 110488468
Gait inability 44.43 9.60 32 95827 136344 110357096
Fibromyalgia 43.89 9.60 50 95809 170859 110322581
Paraplegia 43.68 9.60 39 95820 6161 110487279
Retinal artery occlusion 43.05 9.60 33 95826 4216 110489224
Proctalgia 42.73 9.60 55 95804 13167 110480273
C-reactive protein increased 41.97 9.60 78 95781 217841 110275599
Respiratory tract infection 41.84 9.60 147 95712 71470 110421970
Visual acuity reduced 41.03 9.60 88 95771 32085 110461355
Multiple organ dysfunction syndrome 40.27 9.60 247 95612 151463 110341977
Retinal vasculitis 40.27 9.60 24 95835 2025 110491415
Urinary tract infection 39.66 9.60 445 95414 325837 110167603
SARS-CoV-2 test negative 39.17 9.60 24 95835 2129 110491311
Ophthalmoplegia 39.14 9.60 29 95830 3521 110489919
Interstitial lung disease 38.87 9.60 38 95821 139296 110354144
COVID-19 38.81 9.60 353 95506 244707 110248733
Pulmonary fibrosis 38.74 9.60 20 95839 102022 110391418
Mydriasis 38.46 9.60 69 95790 22088 110471352
Accidental overdose 38.04 9.60 115 95744 51719 110441721
Peripheral nerve injury 38.04 9.60 19 95840 1129 110492311
Adulterated product 37.93 9.60 19 95840 1136 110492304
Vasoplegia syndrome 37.89 9.60 34 95825 5405 110488035
Fear of eating 37.80 9.60 15 95844 513 110492927
Seasonal allergy 37.59 9.60 64 95795 19658 110473782
Hypoaesthesia oral 37.59 9.60 59 95800 16943 110476497
Haemorrhoids 37.09 9.60 90 95769 35582 110457858
Lower respiratory tract infection 37.00 9.60 99 95760 243007 110250433
Anxiety 36.80 9.60 459 95400 344619 110148821
Hepatitis 36.72 9.60 16 95843 90038 110403402
Respiratory tract infection bacterial 36.63 9.60 24 95835 2392 110491048
Appendicolith 36.54 9.60 53 95806 14202 110479238
Colitis ulcerative 36.19 9.60 11 95848 77352 110416088
Meningitis chemical 35.45 9.60 13 95846 357 110493083
Joint range of motion decreased 35.43 9.60 32 95827 121800 110371640
Sinusitis 35.31 9.60 403 95456 296285 110197155
Post procedural complication 35.25 9.60 74 95785 26584 110466856
Brain oedema 35.09 9.60 81 95778 31017 110462423
Inflammation 34.76 9.60 72 95787 193166 110300274
Vascular malformation 34.65 9.60 16 95843 798 110492642
Infusion site haemorrhage 34.55 9.60 30 95829 4568 110488872
Pulmonary oedema 34.09 9.60 175 95684 100484 110392956
Nystagmus 34.08 9.60 46 95813 11531 110481909
Cardiotoxicity 33.80 9.60 56 95803 16825 110476615
Psoriasis 33.77 9.60 43 95816 139950 110353490
Staphylococcal infection 33.73 9.60 135 95724 69809 110423631
Nail disorder 33.69 9.60 5 95854 57930 110435510
Spinal epidural haematoma 33.37 9.60 20 95839 1705 110491735
Drug-induced liver injury 33.20 9.60 33 95826 120034 110373406
Paranasal cyst 33.05 9.60 16 95843 888 110492552
Analgesic therapy 32.99 9.60 36 95823 7248 110486192
Drug therapy 32.96 9.60 36 95823 7255 110486185
Wrong product administered 32.95 9.60 44 95815 10916 110482524
Paralysis 32.93 9.60 53 95806 15547 110477893
Postoperative delirium 32.86 9.60 16 95843 899 110492541
Spinal epidural haemorrhage 32.84 9.60 12 95847 326 110493114
Deep vein thrombosis postoperative 32.52 9.60 6 95853 59285 110434155
Ventricular extrasystoles 32.48 9.60 65 95794 22576 110470864
Tryptase increased 32.41 9.60 16 95843 927 110492513
Hyperphosphataemia 32.34 9.60 54 95805 16327 110477113
Neuralgia 32.29 9.60 104 95755 48374 110445066
Sleep disorder therapy 32.24 9.60 36 95823 7435 110486005
Diarrhoea 32.08 9.60 748 95111 1138757 109354683
Grip strength decreased 31.51 9.60 15 95844 80159 110413281
Anal sphincter atony 31.28 9.60 13 95846 502 110492938
Delayed recovery from anaesthesia 31.16 9.60 21 95838 2194 110491246
Adverse event 31.14 9.60 29 95830 108780 110384660
Stridor 31.09 9.60 34 95825 6861 110486579
Upper respiratory tract infection 30.66 9.60 207 95652 131121 110362319
Oculocardiac reflex 30.47 9.60 9 95850 122 110493318
Lung disorder 29.98 9.60 70 95789 179977 110313463
Accident 29.96 9.60 42 95817 10910 110482530
Febrile neutropenia 29.86 9.60 412 95447 316355 110177085
Trigeminal palsy 29.86 9.60 8 95851 74 110493366
Blood phosphorus increased 29.80 9.60 52 95807 16288 110477152
Respiratory arrest 29.30 9.60 114 95745 58185 110435255
Purtscher retinopathy 29.14 9.60 10 95849 225 110493215
Diabetes insipidus 28.94 9.60 32 95827 6538 110486902
Punctate keratitis 28.72 9.60 16 95843 1188 110492252
Asthenia 28.48 9.60 423 95436 688576 109804864
Blood pressure decreased 28.44 9.60 184 95675 114907 110378533
Infusion site mass 28.25 9.60 18 95841 1710 110491730
Neuromuscular block prolonged 28.20 9.60 16 95843 1231 110492209
Product dose omission issue 28.13 9.60 413 95446 321369 110172071
Incorrect drug administration rate 28.10 9.60 29 95830 5479 110487961
Underdose 28.04 9.60 10 95849 63544 110429896
Therapy partial responder 27.92 9.60 83 95776 36978 110456462
Cyanosis 27.74 9.60 72 95787 29669 110463771
Multiple allergies 27.73 9.60 43 95816 12220 110481220
Myasthenia gravis 27.62 9.60 59 95800 21452 110471988
Gastrointestinal disorder 27.52 9.60 112 95747 241840 110251600
Prescribed underdose 27.51 9.60 11 95848 65163 110428277
Negative pressure pulmonary oedema 27.47 9.60 13 95846 686 110492754
Blepharospasm 27.14 9.60 7 95852 54844 110438596
Frequent bowel movements 27.09 9.60 14 95845 71376 110422064
Epidural haemorrhage 27.04 9.60 11 95848 402 110493038
Coeliac disease 26.87 9.60 3 95856 43184 110450256
Lower limb fracture 26.82 9.60 16 95843 75332 110418108
Neuromuscular blockade 26.69 9.60 13 95846 731 110492709
Chemical burn 26.63 9.60 13 95846 735 110492705
Arthritis 26.45 9.60 67 95792 167519 110325921
Condition aggravated 26.43 9.60 463 95396 734373 109759067
Onychomadesis 26.42 9.60 4 95855 45659 110447781
Platelet aggregation inhibition 26.29 9.60 9 95850 201 110493239
Weight increased 26.17 9.60 235 95624 419409 110074031
Back pain 25.99 9.60 459 95400 370537 110122903
Infusion site urticaria 25.89 9.60 15 95844 1201 110492239
Tracheitis 25.86 9.60 17 95842 1704 110491736
Hyperaesthesia 25.74 9.60 46 95813 14681 110478759
Suicide attempt 25.73 9.60 31 95828 103363 110390077
Bursitis infective 25.70 9.60 16 95843 1460 110491980
Procedural complication 25.67 9.60 34 95825 8371 110485069
Hypophosphataemia 25.66 9.60 75 95784 33107 110460333
Medical device site cellulitis 25.45 9.60 9 95850 222 110493218
Swelling 25.35 9.60 189 95670 350852 110142588
Mean arterial pressure decreased 25.20 9.60 11 95848 480 110492960
Upper airway obstruction 25.15 9.60 17 95842 1785 110491655
Blindness 25.13 9.60 79 95780 36280 110457160
Macular ischaemia 25.08 9.60 9 95850 232 110493208
Pneumocephalus 25.05 9.60 11 95848 487 110492953
Body tinea 24.95 9.60 18 95841 2097 110491343
Foetal heart rate abnormal 24.84 9.60 12 95847 663 110492777
Acute kidney injury 24.59 9.60 395 95464 635035 109858405
Inadequate analgesia 24.59 9.60 26 95833 5051 110488389
Brain stem syndrome 24.55 9.60 15 95844 1324 110492116
Wheezing 24.35 9.60 126 95733 255104 110238336
Stomatitis 24.35 9.60 136 95723 270106 110223334
Parophthalmia 24.27 9.60 11 95848 525 110492915
Myoclonus 24.01 9.60 73 95786 32925 110460515
Epidural analgesia 23.97 9.60 8 95851 165 110493275
Suspected transmission of an infectious agent via product 23.93 9.60 15 95844 1385 110492055
Shock 23.92 9.60 101 95758 53487 110439953
Musculoskeletal pain 23.91 9.60 80 95779 182943 110310497
Spinal cord compression 23.76 9.60 31 95828 7521 110485919
Procedure aborted 23.61 9.60 8 95851 173 110493267
Rash 23.59 9.60 537 95322 820427 109673013
Torsade de pointes 23.48 9.60 57 95802 22543 110470897
Therapeutic product effect incomplete 23.37 9.60 107 95752 223698 110269742
Hepatic cirrhosis 23.18 9.60 15 95844 67611 110425829
Decreased appetite 22.95 9.60 283 95576 475563 110017877
Respiratory distress 22.80 9.60 119 95740 68755 110424685
Lupus-like syndrome 22.65 9.60 4 95855 40788 110452652
Haematochezia 22.54 9.60 41 95818 115483 110377957
Eyelid ptosis 22.49 9.60 41 95818 13286 110480154
Otitis media 22.46 9.60 30 95829 7446 110485994
Medical device site abscess 22.45 9.60 8 95851 202 110493238
Miosis 22.36 9.60 55 95804 21928 110471512
Airway peak pressure increased 22.33 9.60 11 95848 634 110492806
Spinal anaesthesia 22.29 9.60 7 95852 118 110493322
Red blood cell sedimentation rate increased 22.25 9.60 21 95838 78281 110415159
Loss of personal independence in daily activities 22.14 9.60 62 95797 149958 110343482
Drug level increased 22.13 9.60 91 95768 47628 110445812
Prescribed overdose 22.07 9.60 26 95833 87555 110405885
Vitreous floaters 22.03 9.60 33 95826 9101 110484339
Product contamination microbial 21.98 9.60 13 95846 1081 110492359
Drug hypersensitivity 21.92 9.60 270 95589 453820 110039620
Appendicitis 21.69 9.60 64 95795 28400 110465040
Cytomegalovirus infection 21.68 9.60 10 95849 54434 110439006
Mastoiditis 21.59 9.60 18 95841 2593 110490847
Cardio-respiratory arrest 21.56 9.60 173 95686 115663 110377777
Infusion site discharge 21.49 9.60 16 95843 1957 110491483
Nerve root injury 21.46 9.60 6 95853 66 110493374
Blood cholesterol increased 21.35 9.60 85 95774 184700 110308740
Pancreatitis acute 21.17 9.60 13 95846 60261 110433179
Diplopia 21.12 9.60 82 95777 41812 110451628
Anterior chamber fibrin 21.09 9.60 8 95851 242 110493198
Bundle branch block left 20.93 9.60 39 95820 12849 110480591
Foot deformity 20.76 9.60 8 95851 48472 110444968
Behaviour disorder 20.67 9.60 33 95826 9614 110483826
Hepatotoxicity 20.49 9.60 15 95844 63385 110430055
Tenderness 20.38 9.60 64 95795 29373 110464067
Corneal opacity 20.38 9.60 13 95846 1238 110492202
Atonic urinary bladder 20.34 9.60 7 95852 159 110493281
Product preparation error 20.33 9.60 35 95824 10844 110482596
Disease progression 20.29 9.60 126 95733 243908 110249532
Knee arthroplasty 20.18 9.60 16 95843 64932 110428508
Chills 20.08 9.60 253 95606 190327 110303113
Tubulointerstitial nephritis 20.07 9.60 11 95848 54273 110439167
Drug reaction with eosinophilia and systemic symptoms 20.02 9.60 25 95834 82070 110411370
Gastroenteritis viral 19.90 9.60 66 95793 31160 110462280
Economic problem 19.73 9.60 21 95838 4110 110489330
Hip arthroplasty 19.66 9.60 12 95847 55801 110437639
Intracranial hypotension 19.50 9.60 10 95849 628 110492812
Leukopenia 19.46 9.60 65 95794 148726 110344714
Sinus bradycardia 19.41 9.60 63 95796 29420 110464020
Night sweats 19.31 9.60 56 95803 133927 110359513
Peripheral swelling 19.20 9.60 241 95618 403793 110089647
Bacterial infection 19.19 9.60 85 95774 45951 110447489
Restlessness 19.18 9.60 98 95761 56161 110437279
Bulimia nervosa 19.17 9.60 8 95851 312 110493128
Hepatic function abnormal 18.98 9.60 30 95829 89265 110404175
Thrombocytopenia 18.95 9.60 202 95657 348683 110144757
Product use issue 18.79 9.60 176 95683 311519 110181921
Iron deficiency 18.56 9.60 46 95813 18430 110475010
Seizure like phenomena 18.49 9.60 16 95843 2425 110491015
Vocal cord dysfunction 18.34 9.60 11 95848 939 110492501
Epilepsy 18.30 9.60 37 95822 100172 110393268
Respiratory tract infection viral 18.29 9.60 24 95835 5854 110487586
Sepsis 18.17 9.60 391 95468 326955 110166485
Intentional self-injury 18.10 9.60 5 95854 37424 110456016
Sensory loss 18.05 9.60 50 95809 21407 110472033
Vision blurred 18.01 9.60 181 95678 128841 110364599
Quadriplegia 18.00 9.60 20 95839 4107 110489333
Anaphylactoid shock 17.96 9.60 11 95848 975 110492465
Heparin-induced thrombocytopenia 17.85 9.60 34 95825 11390 110482050
Respiratory acidosis 17.84 9.60 38 95821 13788 110479652
Nail bed tenderness 17.77 9.60 8 95851 376 110493064
Hypersensitivity 17.73 9.60 245 95614 403753 110089687
Anal skin tags 17.69 9.60 9 95850 556 110492884
Laryngospasm 17.63 9.60 21 95838 4647 110488793
Spinal meningeal cyst 17.53 9.60 6 95853 134 110493306
Tremor 17.43 9.60 259 95600 201973 110291467
Hypoxic-ischaemic encephalopathy 17.25 9.60 29 95830 8818 110484622
Spinal cord injury 17.02 9.60 13 95846 1652 110491788
Aortic stenosis 16.97 9.60 36 95823 13023 110480417
Pneumocystis jirovecii pneumonia 16.79 9.60 8 95851 42727 110450713
Vitamin D increased 16.79 9.60 10 95849 843 110492597
Bronchitis 16.77 9.60 209 95650 156823 110336617
Serotonin syndrome 16.77 9.60 98 95761 59055 110434385
Skin infection 16.57 9.60 50 95809 22459 110470981
Ear infection 16.55 9.60 102 95757 62630 110430810
Injection site joint infection 16.52 9.60 5 95854 74 110493366
Wound infection 16.46 9.60 37 95822 96428 110397012
Cholestasis 16.42 9.60 19 95840 64499 110428941
Respiratory failure 16.37 9.60 270 95589 215062 110278378
Orthostatic hypotension 16.34 9.60 20 95839 66229 110427211
Sleep disorder 16.28 9.60 103 95756 198541 110294899
Kidney infection 16.22 9.60 54 95805 25545 110467895
Total lung capacity decreased 16.16 9.60 25 95834 7089 110486351
Anaesthetic complication pulmonary 16.12 9.60 6 95853 172 110493268
Atrioventricular block complete 16.11 9.60 46 95813 20036 110473404
Retinal detachment 16.08 9.60 32 95827 11068 110482372
Airway complication of anaesthesia 16.07 9.60 9 95850 675 110492765
Bacteroides infection 16.04 9.60 16 95843 2903 110490537
Reperfusion arrhythmia 16.00 9.60 7 95852 307 110493133
Agitation 15.97 9.60 159 95700 112892 110380548
Agranulocytosis 15.92 9.60 18 95841 61742 110431698
Depressed level of consciousness 15.90 9.60 158 95701 112120 110381320
Infusion site discomfort 15.89 9.60 13 95846 1824 110491616
Vaginal abscess 15.87 9.60 8 95851 485 110492955
Ventricular hypokinesia 15.85 9.60 32 95827 11182 110482258
Anal ulcer 15.65 9.60 13 95846 1863 110491577
Normal newborn 15.52 9.60 48 95811 21848 110471592
Product distribution issue 15.51 9.60 19 95840 4327 110489113
Implant site bruising 15.49 9.60 7 95852 332 110493108
Onychomycosis 15.46 9.60 7 95852 38524 110454916
Cholestasis of pregnancy 15.46 9.60 11 95848 1254 110492186
Bacterial endophthalmitis 15.43 9.60 7 95852 335 110493105
Kidney congestion 15.33 9.60 8 95851 521 110492919
Catecholamine crisis 15.31 9.60 5 95854 96 110493344
Streptococcal infection 15.30 9.60 31 95828 10859 110482581
Ventricular tachyarrhythmia 15.28 9.60 8 95851 525 110492915
Monoplegia 15.21 9.60 20 95839 4889 110488551
Dyspepsia 15.15 9.60 100 95759 190865 110302575
Left ventricle outflow tract obstruction 15.14 9.60 8 95851 535 110492905
Familial periodic paralysis 15.10 9.60 7 95852 352 110493088
Blood uric acid increased 15.08 9.60 47 95812 21482 110471958
Infusion site rash 15.06 9.60 14 95845 2329 110491111
Insomnia 15.00 9.60 221 95638 360369 110133071
Vascular stenosis 15.00 9.60 9 95850 769 110492671
Thrombosis 14.95 9.60 152 95707 108510 110384930
Application site alopecia 14.93 9.60 4 95855 37 110493403
Retrograde amnesia 14.90 9.60 9 95850 778 110492662
Eyelid contusion 14.89 9.60 5 95854 105 110493335
Eclampsia 14.87 9.60 7 95852 365 110493075
Nail bed inflammation 14.76 9.60 13 95846 2017 110491423
Paraesthesia oral 14.67 9.60 63 95796 33608 110459832
Apnoeic attack 14.64 9.60 9 95850 803 110492637
Repetitive strain injury 14.58 9.60 6 95853 226 110493214
Phrenic nerve paralysis 14.55 9.60 8 95851 579 110492861
Vitreous disorder 14.53 9.60 7 95852 384 110493056
Ventricular arrhythmia 14.52 9.60 29 95830 10058 110483382
Infusion site streaking 14.51 9.60 8 95851 582 110492858
Retinal haemorrhage 14.50 9.60 28 95831 9473 110483967
Allodynia 14.47 9.60 13 95846 2070 110491370
Administration site pain 14.45 9.60 9 95850 822 110492618
Cataract nuclear 14.42 9.60 11 95848 1395 110492045
Enterobacter pneumonia 14.32 9.60 8 95851 597 110492843
Spinal cord ischaemia 14.28 9.60 6 95853 238 110493202
Heliotrope rash 14.28 9.60 6 95853 238 110493202
Confusional state 14.16 9.60 304 95555 468376 110025064
Nasopharyngitis 13.98 9.60 249 95610 394112 110099328
Drug resistance 13.92 9.60 17 95842 56357 110437083
Ventricular asystole 13.92 9.60 7 95852 422 110493018
Autoimmune disorder 13.92 9.60 22 95837 65461 110427979
Air embolism 13.90 9.60 8 95851 632 110492808
Oxygen saturation decreased 13.90 9.60 202 95657 156780 110336660
Irregular breathing 13.89 9.60 8 95851 633 110492807
Lung opacity 13.87 9.60 31 95828 11621 110481819
Taste disorder 13.86 9.60 22 95837 65365 110428075
Axillary nerve injury 13.84 9.60 4 95855 50 110493390
Body dysmorphic disorder 13.83 9.60 7 95852 428 110493012
Encephalomalacia 13.78 9.60 11 95848 1491 110491949
Bone marrow failure 13.71 9.60 18 95841 57830 110435610
Harlequin syndrome 13.68 9.60 6 95853 265 110493175
Renal failure 13.67 9.60 274 95585 226300 110267140
Procedural haemorrhage 13.65 9.60 20 95839 5407 110488033
Hypercapnia 13.63 9.60 30 95829 11129 110482311
Nasal mucosal disorder 13.57 9.60 12 95847 1871 110491569
Diabetic ketoacidosis 13.52 9.60 10 95849 42048 110451392
Exophthalmos 13.50 9.60 13 95846 2260 110491180
Malaise 13.47 9.60 462 95397 671357 109822083
Pupillary reflex impaired 13.45 9.60 17 95842 3998 110489442
Chorioretinopathy 13.39 9.60 13 95846 2282 110491158
Glossoptosis 13.39 9.60 6 95853 279 110493161
Brain herniation 13.38 9.60 26 95833 8837 110484603
Erythema 13.36 9.60 339 95520 291108 110202332
Hyperlipidaemia 13.32 9.60 64 95795 35784 110457656
Memory impairment 13.29 9.60 108 95751 196836 110296604
Allergy to immunoglobulin therapy 13.25 9.60 5 95854 149 110493291
Accelerated idioventricular rhythm 13.25 9.60 6 95853 286 110493154
Spinal cord oedema 13.20 9.60 7 95852 471 110492969
Myokymia 13.19 9.60 5 95854 151 110493289
Angioedema 13.18 9.60 137 95722 98363 110395077
Viral infection 13.15 9.60 85 95774 53054 110440386
Back injury 13.13 9.60 13 95846 47386 110446054
Arthritis bacterial 13.12 9.60 29 95830 10791 110482649
Oxidative stress 13.05 9.60 4 95855 62 110493378
C-reactive protein 12.99 9.60 5 95854 30326 110463114
Ophthalmological examination abnormal 12.99 9.60 4 95855 63 110493377
Spinal stroke 12.93 9.60 4 95855 64 110493376
Lethargy 12.92 9.60 131 95728 93445 110399995
Obstruction 12.77 9.60 20 95839 5732 110487708
Calcinosis 12.75 9.60 14 95845 2838 110490602
Acute pulmonary oedema 12.74 9.60 38 95821 16958 110476482
Tinnitus 12.70 9.60 93 95766 60447 110432993
Postictal state 12.70 9.60 13 95846 2433 110491007
Meningitis 12.68 9.60 30 95829 11672 110481768
Depression 12.68 9.60 196 95663 317139 110176301
Femoral nerve injury 12.65 9.60 4 95855 69 110493371
Injury 12.64 9.60 220 95639 177045 110316395
Abortion spontaneous 12.60 9.60 7 95852 34275 110459165
Dystonia 12.59 9.60 50 95809 25755 110467685
Hypoventilation 12.56 9.60 24 95835 8057 110485383
Cytokine release syndrome 12.54 9.60 104 95755 70202 110423238
Infection 12.42 9.60 230 95629 361970 110131470
Anticoagulant therapy 12.40 9.60 19 95840 5342 110488098
Opisthotonus 12.39 9.60 8 95851 778 110492662
Asthma 12.37 9.60 148 95711 250143 110243297
Nerve block 12.36 9.60 8 95851 781 110492659
Product administered at inappropriate site 12.32 9.60 19 95840 5374 110488066
Transferrin decreased 12.31 9.60 7 95852 541 110492899
Exostosis 12.28 9.60 13 95846 45943 110447497
Orbital infection 12.26 9.60 5 95854 184 110493256
Infection susceptibility increased 12.23 9.60 17 95842 4381 110489059
Liver function test abnormal 12.13 9.60 26 95833 68924 110424516
Intentional product use issue 12.10 9.60 147 95712 247759 110245681
Iron binding capacity total decreased 12.09 9.60 7 95852 560 110492880
Antacid therapy 12.08 9.60 19 95840 5465 110487975
Myotonic dystrophy 12.01 9.60 5 95854 194 110493246
White blood cell count decreased 11.98 9.60 134 95725 229256 110264184
Corneal infiltrates 11.96 9.60 6 95853 360 110493080
Atelectasis 11.86 9.60 63 95796 36649 110456791
Hepatocellular injury 11.75 9.60 16 95843 50626 110442814
Arthritis fungal 11.72 9.60 5 95854 206 110493234
Procedural anxiety 11.72 9.60 8 95851 853 110492587
Intentional product misuse to child 11.70 9.60 5 95854 207 110493233
Physical disability 11.68 9.60 18 95841 5088 110488352
Diplegia 11.62 9.60 12 95847 2269 110491171
Deafness bilateral 11.62 9.60 13 95846 2691 110490749
Electrocardiogram T wave inversion 11.58 9.60 19 95840 5661 110487779
Victim of chemical submission 11.57 9.60 8 95851 871 110492569
Poor quality product administered 11.53 9.60 17 95842 4624 110488816
End-tidal CO2 decreased 11.49 9.60 4 95855 94 110493346
Treatment failure 11.49 9.60 170 95689 277064 110216376
Intraocular pressure fluctuation 11.41 9.60 4 95855 96 110493344
Conjunctival oedema 11.38 9.60 10 95849 1546 110491894
Intercepted medication error 11.36 9.60 9 95850 1207 110492233
Quadriparesis 11.34 9.60 17 95842 4690 110488750
Exposure during pregnancy 11.30 9.60 206 95653 167218 110326222
Posterior capsule rupture 11.27 9.60 3 95856 27 110493413
Retinal disorder 11.23 9.60 12 95847 2358 110491082
Melaena 11.23 9.60 27 95832 68730 110424710
Brugada syndrome 11.21 9.60 10 95849 1578 110491862
Amaurosis 11.20 9.60 10 95849 1579 110491861
Laboratory test abnormal 11.20 9.60 13 95846 44066 110449374
Oesophageal obstruction 11.18 9.60 9 95850 1234 110492206
Accidental exposure to product 11.18 9.60 78 95781 49930 110443510
Vasospasm 11.16 9.60 10 95849 1586 110491854
Deafness permanent 11.16 9.60 8 95851 923 110492517
Induration 11.16 9.60 12 95847 2377 110491063
Anaesthetic complication cardiac 11.08 9.60 4 95855 105 110493335
Diabetes mellitus inadequate control 11.06 9.60 6 95853 29769 110463671
Blood pressure systolic increased 11.02 9.60 36 95823 82955 110410485
Blood pressure fluctuation 10.98 9.60 31 95828 74793 110418647
Infusion site nodule 10.95 9.60 6 95853 431 110493009
Premature baby 10.94 9.60 17 95842 4838 110488602
Brain injury 10.94 9.60 31 95828 13445 110479995
Sinusitis bacterial 10.93 9.60 12 95847 2432 110491008
Blindness transient 10.92 9.60 19 95840 5937 110487503
Pupil fixed 10.92 9.60 15 95844 3823 110489617
Inappropriate schedule of product administration 10.90 9.60 242 95617 203395 110290045
Thyrotoxic crisis 10.88 9.60 11 95848 2029 110491411
Intraocular pressure increased 10.84 9.60 27 95832 10849 110482591
Dysarthria 10.78 9.60 116 95743 84005 110409435
Sympathectomy 10.73 9.60 3 95856 33 110493407
Coccygectomy 10.73 9.60 3 95856 33 110493407
Jaundice 10.70 9.60 22 95837 59214 110434226
Application site pain 10.69 9.60 18 95841 5481 110487959
Mean arterial pressure increased 10.67 9.60 4 95855 117 110493323
Injection site joint swelling 10.65 9.60 3 95856 34 110493406
Metastases to liver 10.64 9.60 9 95850 35377 110458063
Vascular resistance systemic decreased 10.61 9.60 5 95854 261 110493179
Accidental death 10.55 9.60 17 95842 4992 110488448
Weight decreased 10.54 9.60 317 95542 467740 110025700
Pruritus 10.50 9.60 405 95454 581155 109912285
Incontinence 10.46 9.60 35 95824 16600 110476840
Glucose tolerance impaired 10.42 9.60 25 95834 9812 110483628
Pneumonia mycoplasmal 10.42 9.60 10 95849 1731 110491709
Cancer pain 10.39 9.60 20 95839 6752 110486688
Device infusion issue 10.37 9.60 13 95846 3032 110490408
Tachypnoea 10.36 9.60 64 95795 39331 110454109
Pancytopenia 10.34 9.60 124 95735 209489 110283951
Malignant neoplasm progression 10.33 9.60 99 95760 174468 110318972
Muscle strain 10.32 9.60 27 95832 11175 110482265
Haemorrhagic vasculitis 10.30 9.60 4 95855 129 110493311
Poikiloderma 10.29 9.60 6 95853 486 110492954
Anaphylactoid reaction 10.28 9.60 20 95839 6806 110486634
Incision site rash 10.27 9.60 3 95856 39 110493401
Syringomyelia 10.27 9.60 5 95854 281 110493159
Injection site atrophy 10.21 9.60 6 95853 493 110492947
Corneal abrasion 10.20 9.60 9 95850 1400 110492040
Treatment noncompliance 10.16 9.60 31 95828 72959 110420481
Anterior chamber inflammation 10.08 9.60 7 95852 768 110492672
Tracheal deviation 10.07 9.60 5 95854 293 110493147
Gamma-glutamyltransferase increased 10.07 9.60 24 95835 61285 110432155
Skin test positive 9.98 9.60 9 95850 1440 110492000
Neuroleptic malignant syndrome 9.83 9.60 9 95850 34050 110459390
Disease recurrence 9.82 9.60 24 95835 60760 110432680
Infusion site oedema 9.82 9.60 9 95850 1471 110491969
Sinus arrest 9.77 9.60 15 95844 4227 110489213
Acute respiratory failure 9.75 9.60 104 95755 75156 110418284
Chorea 9.75 9.60 13 95846 3222 110490218
Sciatica 9.74 9.60 44 95815 92355 110401085
Central pain syndrome 9.72 9.60 7 95852 813 110492627
Lung neoplasm malignant 9.70 9.60 9 95850 33833 110459607
Prostate cancer 9.67 9.60 11 95848 37630 110455810
Retinal cyst 9.66 9.60 4 95855 153 110493287
Hypercalcaemia 9.61 9.60 16 95843 46641 110446799

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C05AD02 CARDIOVASCULAR SYSTEM
VASOPROTECTIVES
AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
Local anesthetics
ATC D04AB06 DERMATOLOGICALS
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
Anesthetics for topical use
ATC N01BA03 NERVOUS SYSTEM
ANESTHETICS
ANESTHETICS, LOCAL
Esters of aminobenzoic acid
ATC N01BA53 NERVOUS SYSTEM
ANESTHETICS
ANESTHETICS, LOCAL
Esters of aminobenzoic acid
ATC S01HA03 SENSORY ORGANS
OPHTHALMOLOGICALS
LOCAL ANESTHETICS
Local anesthetics
FDA CS M0007766 Esters
MeSH PA D000777 Anesthetics
MeSH PA D000779 Anesthetics, Local
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D018689 Sensory System Agents
FDA EPC N0000175683 Ester Local Anesthetic
FDA PE N0000175976 Local Anesthesia
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:36333 local anaesthetic
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:73336 vulnerary
CHEBI has role CHEBI:38867 anaesthetic

Related Drugs by ATC class:

C05AD Local anesthetics 6 drugs
benzocainecinchocainelidocaineoxetacainepramocaineprocaine
D04AB Anesthetics for topical use 6 drugs
benzocainecinchocainelidocaineoxybuprocainepramocainequinisocaine
N01BA Esters of aminobenzoic acid 4 drugs
benzocainechloroprocainemetabutethamineprocaine
S01HA Local anesthetics 7 drugs
chloroprocainecinchocainecocainelidocaineoxybuprocaineprocaineproparacaine

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

DiseaseRelationSNOMED_IDDOID
Local anesthetic intrathecal block indication 231249005
Skin irritation indication 367466007
Local anesthesia indication 386761002
Itching of skin indication 418363000
Minor Skin Wound Pain indication
Local Anesthesia for Ophthalmologic Procedure indication
Administration of Corneal Anesthesia indication
Hyperthyroidism contraindication 34486009 DOID:7998
Conduction disorder of the heart contraindication 44808001
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Heart disease contraindication 56265001 DOID:114
Decreased respiratory function contraindication 80954004
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Magnetic resonance imaging contraindication 113091000
Open wound contraindication 125643001
Eye infection contraindication 128351009
Uveitis contraindication 128473001 DOID:13141
Seizure disorder contraindication 128613002
Disease of liver contraindication 235856003 DOID:409
Deficiency of cholinesterase contraindication 360607009
Denuded skin contraindication 418242004




🐶 Veterinary Drug Use

SpeciesUseRelation
Cats Acute otitis externa Indication
Cats Chronic otitis externa Indication
Cats Ear canker Indication
Cats Inflammatory conditions of the external ear canal Indication
Cats Dressing for minor cuts, lacerations, abrasions, and post-surgical therapy Indication
Cats Following amputation of dewclaw Indication
Cats Following amputation of tails and claws Indication
Cats Following ear trimming Indication
Cats Following castrating operations Indication
Dogs Acute otitis externa Indication
Dogs Chronic otitis externa Indication
Dogs Ear canker Indication
Dogs Inflammatory conditions of the external ear canal Indication
Dogs Following amputation of dewclaw Indication
Dogs Following amputation of tails and claws Indication
Dogs Following ear trimming Indication
Dogs Following castrating operations Indication
Horses Superficial dressing applied to minor cuts Indication
Horses Pain after post-surgery Indication
Horses Superficial dressing applied to wounds Indication
Horses Superficial dressing applied to lacerations Indication
Horses Superficial dressing applied to abrasions Indication

🐶 Veterinary products

ProductApplicantIngredients
Neo-Cortef with Tetracaine Zoetis Inc. 3
Neo-Delta-Cortef with Tetracaine Ointment Zoetis Inc. 3
Neo-Predef with Tetracaine Powder Zoetis Inc. 3
Neo-Predef with Tetracaine Top. Ointment, Tritop Topical Ointment Zoetis Inc. 3

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.51 Basic
pKa2 2.67 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.1MG/SPRAY;6MG/SPRAY KOVANAZE ST RENATUS N208032 June 29, 2016 RX SPRAY, METERED NASAL 8580282 April 2, 2030 METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH
0.1MG/SPRAY;6MG/SPRAY KOVANAZE ST RENATUS N208032 June 29, 2016 RX SPRAY, METERED NASAL 9308191 April 2, 2030 METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH
7%;7% PLIAGLIS CRESCITA THERAP N021717 June 29, 2006 RX CREAM TOPICAL 12558328 Jan. 14, 2031 A METHOD OF APPLYING A SOLID FORMING LOCAL ANESTHETIC FORMULATION TO A SKIN SURFACE, ALLOWING THE LAYER TO FORM A COHESIVE FILM, AND REMOVING THE FILM LAYER BY PEELING FROM THE SKIN SURFACE AS ONE, TWO OR THREE LARGE PIECES

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Sodium channel protein type 5 subunit alpha Ion channel BLOCKER IC50 6.28 CHEMBL CHEMBL
Sodium channel protein type 2 subunit alpha Ion channel BLOCKER IC50 5.96 CHEMBL CHEMBL
Sodium channel protein type 9 subunit alpha Ion channel BLOCKER Ki 6.30 CHEMBL CHEMBL
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel BLOCKER IC50 5.47 CHEMBL CHEMBL
Sodium channel protein type 8 subunit alpha Ion channel IC50 6.28 CHEMBL
Amine oxidase [flavin-containing] A Enzyme IC50 6.50 DRUG MATRIX
Sodium channel protein type 7 subunit alpha Ion channel IC50 7.25 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 6.15 DRUG MATRIX
5-hydroxytryptamine receptor 2A GPCR Ki 6.01 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 5.77 DRUG MATRIX
cGMP-gated cation channel alpha-1 Ion channel Kd 5.17 CHEMBL
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel IC50 5.22 CHEMBL

External reference:

IDSource
4019456 VUID
N0000147578 NUI
D00551 KEGG_DRUG
136-47-0 SECONDARY_CAS_RN
4018254 VANDF
4019456 VANDF
C0039629 UMLSCUI
CHEBI:9468 CHEBI
TE4 PDB_CHEM_ID
CHEMBL698 ChEMBL_ID
DB09085 DRUGBANK_ID
CHEMBL1255654 ChEMBL_ID
D013748 MESH_DESCRIPTOR_UI
5411 PUBCHEM_CID
431 INN_ID
0619F35CGV UNII
10391 RXNORM
177214 MMSL
5559 MMSL
5560 MMSL
59765 MMSL
5987 MMSL
80869 MMSL
d01217 MMSL
001361 NDDF
001362 NDDF
387309008 SNOMEDCT_US
51844001 SNOMEDCT_US
55556000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Tetracaine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0065-0741 SOLUTION 5 mg OPHTHALMIC NDA 24 sections
Tetracaine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0187-0920 SOLUTION/ DROPS 5 mg OPHTHALMIC NDA 24 sections
Cetacaine Anesthetic HUMAN PRESCRIPTION DRUG LABEL 3 10223-0201 AEROSOL, SPRAY 0.00 g TOPICAL UNAPPROVED DRUG OTHER 12 sections
Cetacaine Anesthetic HUMAN PRESCRIPTION DRUG LABEL 3 10223-0202 SOLUTION 0.00 g TOPICAL UNAPPROVED DRUG OTHER 12 sections
Cetacaine Topical Anesthetic HUMAN PRESCRIPTION DRUG LABEL 3 10223-0217 GEL 0.00 g TOPICAL UNAPPROVED DRUG OTHER 11 sections
Cetacaine Topical Anesthetic HUMAN PRESCRIPTION DRUG LABEL 3 10223-0221 GEL 0.00 g TOPICAL UNAPPROVED DRUG OTHER 11 sections
Cetacaine Anesthetic HUMAN PRESCRIPTION DRUG LABEL 3 10223-0225 SOLUTION 0.00 g TOPICAL UNAPPROVED DRUG OTHER 12 sections
Cetacaine Anesthetic HUMAN PRESCRIPTION DRUG LABEL 3 10223-0226 SOLUTION 0.00 g TOPICAL UNAPPROVED DRUG OTHER 12 sections
Tetracaine HUMAN PRESCRIPTION DRUG LABEL 1 17478-045 INJECTION 10 mg SUBARACHNOID unapproved drug other 19 sections
Tetracaine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 24208-092 SOLUTION/ DROPS 5 mg OPHTHALMIC NDA 25 sections
Burn Cream HUMAN OTC DRUG LABEL 1 37945-212 CREAM 10 mg TOPICAL OTC monograph not final 11 sections
Tetracaine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-2364 SOLUTION 5 mg OPHTHALMIC NDA 24 sections
Cutiecaine HUMAN OTC DRUG LABEL 2 50876-182 CREAM 20 mg TOPICAL OTC monograph not final 10 sections
Tetracaine HCL HUMAN PRESCRIPTION DRUG LABEL 1 54288-127 INJECTION 10 mg SUBARACHNOID unapproved drug other 11 sections
FranklyNumb 3 HUMAN OTC DRUG LABEL 1 54723-004 CREAM 2 g TOPICAL OTC monograph not final 9 sections
Inderma MD HUMAN OTC DRUG LABEL 1 54723-011 CREAM 2 g TOPICAL OTC monograph not final 9 sections
PENICHILLIN HUMAN OTC DRUG LABEL 1 54723-014 CREAM 2 g TOPICAL OTC monograph not final 9 sections
Painless Tattoo 3 HUMAN OTC DRUG LABEL 1 54723-017 CREAM 2 g TOPICAL OTC Monograph Drug 8 sections
Painless Tattoo 3 HUMAN OTC DRUG LABEL 1 54723-017 CREAM 2 g TOPICAL OTC Monograph Drug 8 sections
NeuroMed Topical Analgesic LA HUMAN OTC DRUG LABEL 1 54723-310 CREAM 20 mg TOPICAL OTC Monograph Drug 12 sections
NeuroMed Topical Analgesic LA HUMAN OTC DRUG LABEL 1 54723-310 CREAM 20 mg TOPICAL OTC Monograph Drug 12 sections
Eclipse Topical AnalgesicLL HUMAN OTC DRUG LABEL 1 54723-669 CREAM 20 mg TOPICAL OTC monograph not final 11 sections
Eclipse Topical AnalgesicLL HUMAN OTC DRUG LABEL 1 54723-669 CREAM 20 mg TOPICAL OTC monograph not final 11 sections
Eclipse Topical AnalgesicLL HUMAN OTC DRUG LABEL 1 54723-669 CREAM 20 mg TOPICAL OTC monograph not final 11 sections
Comfortox Tetracaine HUMAN OTC DRUG LABEL 1 54723-997 CREAM 20 mg TOPICAL OTC Monograph Drug 11 sections
Numfast Tetracaine Green HUMAN OTC DRUG LABEL 1 67194-020 CREAM 20 mg TOPICAL OTC Monograph Drug 12 sections
Tetracaine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 68682-920 SOLUTION/ DROPS 5 mg OPHTHALMIC NDA 25 sections
Tetracaine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 68682-920 SOLUTION/ DROPS 5 mg OPHTHALMIC NDA 25 sections
Kovanaze HUMAN PRESCRIPTION DRUG LABEL 2 69803-100 SPRAY 30 mg NASAL NDA 23 sections
Tetracaine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 70069-596 SOLUTION 5 mg OPHTHALMIC ANDA 23 sections