lidocaine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
local anaesthetics 1579 137-58-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • lignocaine
  • lidocaine
  • xylocain
  • dalcaine
  • duncaine
  • esracaine
  • solarcaine
  • lidocaine hydrochloride
  • lidocaine hydrochloride anhydrous
  • lidocaine hydrochloride hydrate
  • lidocaine HCl
A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.
  • Molecular weight: 234.34
  • Formula: C14H22N2O
  • CLOGP: 1.95
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 1
  • TPSA: 32.34
  • ALOGS: -2.60
  • ROTB: 5

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
3 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 3.58 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 8 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 18.29 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 35 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.80 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 16 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.33 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.60 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 19, 1948 FDA FRESENIUS KABI USA

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
Product adhesion issue 1082.93 9.53 363 79206 4029 50521526
Product quality issue 493.10 9.53 400 79169 30458 50495097
Local anaesthetic systemic toxicity 374.70 9.53 102 79467 510 50525045
Toxic anterior segment syndrome 247.30 9.53 93 79476 1472 50524083
Sinusitis 230.43 9.53 689 78880 169869 50355686
Anaesthetic complication 200.05 9.53 82 79487 1648 50523907
Infusion site swelling 189.40 9.53 126 79443 7050 50518505
Drug intolerance 173.28 9.53 64 79505 219040 50306515
Anaphylactic shock 167.97 9.53 182 79387 19973 50505582
Pemphigus 162.46 9.53 6 79563 120160 50405395
Contraindicated product administered 155.82 9.53 24 79545 148934 50376621
Cardiac arrest 151.90 9.53 377 79192 83274 50442281
Infusion site erythema 149.69 9.53 118 79451 8609 50516946
Lagophthalmos 147.86 9.53 42 79527 252 50525303
Infusion site pain 146.31 9.53 135 79434 12211 50513344
Anaphylactic reaction 146.29 9.53 286 79283 53769 50471786
Drug ineffective for unapproved indication 143.17 9.53 172 79397 21109 50504446
Hand deformity 142.82 9.53 3 79566 100196 50425359
Joint swelling 129.57 9.53 117 79452 245169 50280386
Systemic lupus erythematosus 127.48 9.53 32 79537 140590 50384965
Glossodynia 124.61 9.53 17 79552 115552 50410003
Completed suicide 119.57 9.53 30 79539 131859 50393696
Synovitis 118.62 9.53 25 79544 123840 50401715
Infusion site extravasation 110.44 9.53 90 79479 6886 50518669
Methaemoglobinaemia 110.19 9.53 57 79512 1985 50523570
Infusion site pruritus 101.18 9.53 68 79501 3869 50521686
Hepatic enzyme increased 100.60 9.53 45 79524 137335 50388220
Alopecia 95.09 9.53 149 79420 244898 50280657
Arthropathy 84.90 9.53 74 79495 157832 50367723
Corneal oedema 84.43 9.53 42 79527 1345 50524210
Pericarditis 83.81 9.53 12 79557 78677 50446878
Pulseless electrical activity 83.38 9.53 76 79493 6765 50518790
Wound 83.38 9.53 31 79538 105763 50419792
Bradycardia 80.94 9.53 254 79315 64172 50461383
Abdominal discomfort 75.37 9.53 157 79412 231484 50294071
Stress cardiomyopathy 72.40 9.53 75 79494 7812 50517743
Maternal exposure during delivery 71.89 9.53 34 79535 972 50524583
Rheumatoid arthritis 71.33 9.53 131 79438 202419 50323136
Infusion site nodule 71.19 9.53 35 79534 1092 50524463
Treatment failure 69.83 9.53 68 79501 137569 50387986
Infusion site haemorrhage 68.03 9.53 48 79521 2956 50522599
Therapy interrupted 66.27 9.53 116 79453 20036 50505519
General physical health deterioration 62.77 9.53 79 79490 142355 50383200
Helicobacter infection 62.29 9.53 4 79565 49698 50475857
Infusion site bruising 62.26 9.53 41 79528 2254 50523301
Generalised tonic-clonic seizure 61.42 9.53 131 79438 26179 50499376
Body tinea 60.21 9.53 33 79536 1294 50524261
Extradural abscess 60.01 9.53 28 79541 776 50524779
Pulse absent 59.76 9.53 54 79515 4752 50520803
Administration site swelling 58.73 9.53 30 79539 1017 50524538
Type I hypersensitivity 58.44 9.53 40 79529 2345 50523210
Incorrect route of product administration 58.23 9.53 105 79464 18561 50506994
Upper respiratory tract infection 57.92 9.53 231 79338 65667 50459888
Seizure 54.87 9.53 345 79224 117529 50408026
COVID-19 53.20 9.53 178 79391 46484 50479071
Drug ineffective 52.78 9.53 940 78629 818393 49707162
Unresponsive to stimuli 52.42 9.53 135 79434 30474 50495081
Administration site pain 52.15 9.53 24 79545 644 50524911
Arthralgia 51.91 9.53 441 79128 438261 50087294
Incorrect drug administration rate 50.74 9.53 38 79531 2568 50522987
Ear infection 50.23 9.53 120 79449 25850 50499705
Therapeutic product effect decreased 49.65 9.53 86 79483 135964 50389591
Bronchitis 48.56 9.53 305 79264 103854 50421701
Procedural hypotension 46.16 9.53 26 79543 1076 50524479
Ventricular tachycardia 45.58 9.53 86 79483 15735 50509820
Extradural haematoma 44.63 9.53 29 79540 1558 50523997
Anaesthetic complication neurological 44.52 9.53 15 79554 169 50525386
Sensory loss 43.21 9.53 57 79512 7681 50517874
Infusion site urticaria 42.79 9.53 24 79545 985 50524570
Hypotension 42.60 9.53 561 79008 234908 50290647
Folliculitis 41.71 9.53 6 79563 39219 50486336
Acute motor-sensory axonal neuropathy 41.49 9.53 16 79553 272 50525283
Abortion spontaneous 40.86 9.53 8 79561 41764 50483791
Infection susceptibility increased 40.19 9.53 33 79536 2551 50523004
Inhibitory drug interaction 40.04 9.53 31 79538 2202 50523353
Pneumocephalus 39.71 9.53 13 79556 133 50525422
Ophthalmoplegia 38.95 9.53 25 79544 1315 50524240
Muscle injury 38.72 9.53 6 79563 37105 50488450
Staphylococcal infection 38.08 9.53 133 79436 35483 50490072
Sleep disorder due to general medical condition, insomnia type 38.05 9.53 3 79566 31444 50494111
Vitritis 37.46 9.53 21 79548 861 50524694
Hypopyon 37.04 9.53 19 79550 650 50524905
Infusion site mass 36.55 9.53 23 79546 1169 50524386
Platelet aggregation inhibition 36.54 9.53 12 79557 124 50525431
Ventricular fibrillation 36.31 9.53 62 79507 10497 50515058
Post procedural complication 36.17 9.53 76 79493 15028 50510527
Septic arthritis staphylococcal 36.07 9.53 16 79553 393 50525162
Retinal vasculitis 35.72 9.53 20 79549 818 50524737
Cauda equina syndrome 34.90 9.53 19 79550 735 50524820
Application site rash 34.37 9.53 29 79540 2328 50523227
Mental status changes 34.18 9.53 130 79439 36142 50489413
Infusion site rash 34.05 9.53 23 79546 1319 50524236
Anterior chamber cell 33.18 9.53 16 79553 478 50525077
Urinary tract infection 33.03 9.53 515 79054 223505 50302050
Headache 32.97 9.53 1035 78534 505500 50020055
Systemic toxicity 32.60 9.53 8 79561 24 50525531
Procedural complication 32.46 9.53 39 79530 4784 50520771
Apnoea 32.42 9.53 47 79522 6919 50518636
Diplopia 32 9.53 84 79485 19176 50506379
Administration site erythema 31.97 9.53 16 79553 519 50525036
Infusion site reaction 31.88 9.53 27 79542 2179 50523376
Dermatitis contact 31.37 9.53 52 79517 8594 50516961
Paralysis 31.29 9.53 52 79517 8612 50516943
Fear 31.18 9.53 70 79499 14479 50511076
Bursitis infective 30.96 9.53 21 79548 1213 50524342
Surgery 30.75 9.53 111 79458 30094 50495461
Nerve block 30.66 9.53 15 79554 463 50525092
Respiratory tract infection 30.37 9.53 115 79454 31902 50493653
Nerve root injury 30.07 9.53 8 79561 36 50525519
Peripheral nerve injury 30.00 9.53 14 79555 388 50525167
Aqueous fibrin 29.90 9.53 9 79560 68 50525487
COVID-19 immunisation 29.63 9.53 17 79552 729 50524826
Corneal epithelium defect 29.21 9.53 13 79556 322 50525233
Bronchospasm 29.11 9.53 69 79500 14785 50510770
Glucose tolerance impaired 29.04 9.53 38 79531 5080 50520475
Fear of eating 29.02 9.53 13 79556 327 50525228
Renal injury 28.87 9.53 50 79519 8561 50516994
Meningitis chemical 28.74 9.53 10 79559 125 50525430
Product use issue 28.71 9.53 129 79440 149346 50376209
Upper airway obstruction 28.09 9.53 15 79554 558 50524997
Rash 27.96 9.53 502 79067 436969 50088586
Mobility decreased 27.84 9.53 52 79517 79896 50445659
Eyelid ptosis 27.72 9.53 41 79528 6146 50519409
Arthritis bacterial 27.70 9.53 39 79530 5590 50519965
Blood pressure decreased 27.47 9.53 166 79403 55743 50469812
Illness 27.42 9.53 93 79476 24447 50501108
Unevaluable event 27.42 9.53 144 79425 45922 50479633
Swelling 27.38 9.53 194 79375 200678 50324877
Endophthalmitis 27.25 9.53 28 79541 2888 50522667
C-reactive protein increased 27.10 9.53 39 79530 66435 50459120
Suicide attempt 26.87 9.53 25 79544 51707 50473848
Parophthalmia 26.78 9.53 12 79557 302 50525253
Spinal epidural haemorrhage 26.74 9.53 9 79560 101 50525454
Anaphylactoid shock 26.64 9.53 12 79557 306 50525249
Lower respiratory tract infection 26.53 9.53 70 79499 95131 50430424
Anhedonia 26.48 9.53 51 79518 9473 50516082
Emotional distress 26.40 9.53 102 79467 28561 50496994
Infusion site warmth 25.91 9.53 20 79549 1414 50524141
Injury 25.80 9.53 148 79421 48777 50476778
Discomfort 25.64 9.53 86 79483 108294 50417261
Impaired healing 25.55 9.53 44 79525 69742 50455813
Neurotoxicity 25.22 9.53 65 79504 14675 50510880
Diarrhoea 25.20 9.53 719 78850 587757 49937798
Spinal anaesthesia 24.93 9.53 7 79562 40 50525515
Visual acuity reduced 24.90 9.53 79 79490 20060 50505495
Kounis syndrome 24.83 9.53 18 79551 1157 50524398
Acute kidney injury 24.80 9.53 234 79335 227824 50297731
Musculoskeletal stiffness 24.60 9.53 111 79458 128370 50397185
Product contamination microbial 24.44 9.53 10 79559 200 50525355
Neutropenia 24.24 9.53 135 79434 147830 50377725
C-reactive protein abnormal 23.91 9.53 7 79562 27802 50497753
Application site irritation 23.82 9.53 20 79549 1595 50523960
Myopathy toxic 23.76 9.53 12 79557 397 50525158
Tryptase increased 23.73 9.53 10 79559 216 50525339
Anaphylactoid reaction 23.67 9.53 28 79541 3378 50522177
Bundle branch block left 23.32 9.53 38 79531 6192 50519363
Retinal artery occlusion 23.15 9.53 19 79550 1468 50524087
Tachycardia 22.98 9.53 249 79320 99514 50426041
Spinal epidural haematoma 22.85 9.53 16 79553 973 50524582
Lactic acidosis 22.76 9.53 12 79557 33343 50492212
Administration site extravasation 22.33 9.53 14 79555 707 50524848
Nystagmus 22.29 9.53 35 79534 5526 50520029
Cyanosis 22.01 9.53 63 79506 15121 50510434
Kidney infection 21.79 9.53 72 79497 18674 50506881
Peripheral swelling 21.67 9.53 213 79356 205723 50319832
Removal of foreign body 21.49 9.53 5 79564 11 50525544
Arachnoiditis 21.47 9.53 10 79559 276 50525279
Intentional self-injury 21.43 9.53 5 79564 23107 50502448
Impaired quality of life 21.40 9.53 36 79533 6020 50519535
Migraine 21.25 9.53 196 79373 75084 50450471
Neuromuscular block prolonged 21.25 9.53 12 79557 499 50525056
Poor quality sleep 21.23 9.53 66 79503 16580 50508975
Liver function test abnormal 21.23 9.53 23 79546 44316 50481239
Type 2 diabetes mellitus 21.15 9.53 14 79555 34361 50491194
Embolia cutis medicamentosa 21.04 9.53 10 79559 289 50525266
Atonic urinary bladder 20.45 9.53 7 79562 83 50525472
Punctate keratitis 20.29 9.53 12 79557 545 50525010
Shock 20.27 9.53 75 79494 20575 50504980
Pneumonia mycoplasmal 20.24 9.53 14 79555 835 50524720
Blister 20.05 9.53 68 79501 85350 50440205
Psoriatic arthropathy 19.76 9.53 27 79542 47005 50478550
Trigemino-cardiac reflex 19.52 9.53 6 79563 49 50525506
Trigeminal palsy 19.47 9.53 5 79564 19 50525536
Mydriasis 19.37 9.53 48 79521 10579 50514976
Sopor 19.04 9.53 4 79565 19875 50505680
Infusion site irritation 19.01 9.53 12 79557 613 50524942
Application site discomfort 18.95 9.53 10 79559 363 50525192
Hypersensitivity 18.87 9.53 232 79337 214929 50310626
Application site erythema 18.80 9.53 29 79540 4509 50521046
Conjunctival oedema 18.70 9.53 12 79557 631 50524924
Respiratory depression 18.56 9.53 51 79518 11959 50513596
Paraplegia 18.44 9.53 21 79548 2433 50523122
Application site vesicles 18.39 9.53 16 79553 1339 50524216
Glossoptosis 18.19 9.53 6 79563 63 50525492
Airway peak pressure increased 18.15 9.53 9 79560 286 50525269
Therapy cessation 18.09 9.53 85 79484 25926 50499629
Spinal cord oedema 18.05 9.53 7 79562 121 50525434
Status epilepticus 17.88 9.53 54 79515 13352 50512203
Drug resistance 17.82 9.53 4 79565 18985 50506570
Environmental exposure 17.62 9.53 6 79563 70 50525485
Administration site reaction 17.62 9.53 8 79561 208 50525347
Propionibacterium infection 17.60 9.53 5 79564 30 50525525
Infusion site discomfort 17.53 9.53 13 79556 865 50524690
Intentional overdose 17.37 9.53 46 79523 62458 50463097
Cellulitis 17.37 9.53 179 79390 70619 50454936
Toxicity to various agents 17.30 9.53 447 79122 212052 50313503
Piloerection 17.30 9.53 9 79560 317 50525238
Vitamin D increased 17.30 9.53 11 79558 569 50524986
Hypoaesthesia oral 17.02 9.53 46 79523 10682 50514873
Blood creatinine increased 16.96 9.53 62 79507 76098 50449457
Condition aggravated 16.75 9.53 348 79221 296710 50228845
Circulatory collapse 16.68 9.53 69 79500 19931 50505624
Cutis laxa 16.49 9.53 7 79562 154 50525401
Aspiration joint abnormal 16.37 9.53 3 79566 0 50525555
Leukopenia 16.37 9.53 53 79516 67475 50458080
Eye infarction 16.36 9.53 5 79564 40 50525515
Back pain 16.25 9.53 457 79112 219573 50305982
Inadequate analgesia 16.10 9.53 20 79549 2538 50523017
Axillary nerve injury 16.06 9.53 4 79565 13 50525542
Accidental overdose 15.98 9.53 67 79502 19466 50506089
Ventricular hypokinesia 15.89 9.53 25 79544 3955 50521600
Spinal cord compression 15.79 9.53 24 79545 3685 50521870
Foetal heart rate abnormal 15.75 9.53 10 79559 516 50525039
Stridor 15.66 9.53 22 79547 3147 50522408
Drug reaction with eosinophilia and systemic symptoms 15.65 9.53 13 79556 28411 50497144
Ventricular extrasystoles 15.60 9.53 44 79525 10472 50515083
Hepatotoxicity 15.55 9.53 12 79557 27214 50498341
Phrenic nerve paralysis 15.51 9.53 6 79563 103 50525452
Hip arthroplasty 15.45 9.53 15 79554 30414 50495141
Pneumonia 15.44 9.53 735 78834 377666 50147889
Liver injury 15.40 9.53 10 79559 24796 50500759
Asthenia 15.38 9.53 383 79186 318659 50206896
Therapeutic product effect incomplete 15.25 9.53 83 79486 91432 50434123
Laryngeal oedema 15.22 9.53 28 79541 5025 50520530
Bone density decreased 15.14 9.53 45 79524 11030 50514525
Tracheal deviation 15.03 9.53 5 79564 54 50525501
Hypoxia 14.88 9.53 134 79435 50989 50474566
No adverse event 14.81 9.53 97 79472 33481 50492074
Incision site rash 14.69 9.53 4 79565 20 50525535
Ill-defined disorder 14.61 9.53 41 79528 54613 50470942
Retinal haemorrhage 14.58 9.53 26 79543 4555 50521000
Nail bed tenderness 14.43 9.53 8 79561 321 50525234
Cranial nerve palsies multiple 14.23 9.53 4 79565 23 50525532
Respiratory arrest 14.04 9.53 88 79481 29921 50495634
Intentional dose omission 13.99 9.53 27 79542 5023 50520532
Pupillary reflex impaired 13.97 9.53 16 79553 1865 50523690
Anal sphincter atony 13.96 9.53 7 79562 228 50525327
Device expulsion 13.74 9.53 15 79554 28807 50496748
Maternal exposure during pregnancy 13.73 9.53 173 79396 159605 50365950
Myelitis transverse 13.71 9.53 12 79557 1012 50524543
Hemiplegic migraine 13.60 9.53 5 79564 74 50525481
Spinal cord infarction 13.58 9.53 7 79562 242 50525313
Sinus tachycardia 13.57 9.53 68 79501 21286 50504269
Loss of consciousness 13.53 9.53 235 79334 104118 50421437
Hyponatraemia 13.50 9.53 92 79477 96047 50429508
Uterine hypertonus 13.42 9.53 7 79562 248 50525307
Corneal abrasion 13.39 9.53 11 79558 851 50524704
Foetal exposure during pregnancy 13.31 9.53 14 79555 27345 50498210
Purpura 13.29 9.53 40 79529 9871 50515684
Monoplegia 13.28 9.53 19 79550 2764 50522791
Cataract nuclear 13.27 9.53 11 79558 862 50524693
Arthritis 13.19 9.53 81 79488 86640 50438915
Body dysmorphic disorder 13.17 9.53 7 79562 258 50525297
Loss of personal independence in daily activities 13.11 9.53 61 79508 69989 50455566
Blood cholesterol increased 12.93 9.53 44 79525 55171 50470384
Tooth infection 12.82 9.53 50 79519 14062 50511493
Electrocardiogram ST segment elevation 12.75 9.53 21 79548 3452 50522103
Cholestasis of pregnancy 12.69 9.53 12 79557 1119 50524436
Oesophageal adenocarcinoma recurrent 12.67 9.53 4 79565 36 50525519
Product contamination 12.66 9.53 9 79560 561 50524994
Anxiety 12.58 9.53 367 79202 177239 50348316
Harlequin syndrome 12.58 9.53 4 79565 37 50525518
Seasonal allergy 12.53 9.53 51 79518 14625 50510930
Vascular resistance systemic decreased 12.50 9.53 5 79564 94 50525461
Nerve injury 12.45 9.53 35 79534 8315 50517240
Paranasal cyst 12.40 9.53 7 79562 291 50525264
Electrocardiogram QRS complex shortened 12.38 9.53 8 79561 426 50525129
Diplegia 12.30 9.53 11 79558 955 50524600
Administration site irritation 12.30 9.53 4 79565 40 50525515
Red blood cell sedimentation rate increased 12.24 9.53 17 79552 29399 50496156
Application site alopecia 12.23 9.53 3 79566 9 50525546
Orbital infection 12.21 9.53 4 79565 41 50525514
Incontinence 12.19 9.53 39 79530 9946 50515609
Drug hypersensitivity 12.08 9.53 496 79073 250514 50275041
Genital ulceration 12.06 9.53 8 79561 445 50525110
Abdominal pain upper 12.06 9.53 177 79392 159132 50366423
Irregular breathing 12.02 9.53 7 79562 309 50525246
Implant site swelling 11.89 9.53 8 79561 456 50525099
Autonomic neuropathy 11.85 9.53 11 79558 1002 50524553
Anal skin tags 11.81 9.53 7 79562 319 50525236
Administration site scar 11.72 9.53 4 79565 47 50525508
Quadriplegia 11.70 9.53 14 79555 1709 50523846
Epidural analgesia 11.57 9.53 4 79565 49 50525506
Akinesia 11.56 9.53 13 79556 1486 50524069
Skin test positive 11.54 9.53 9 79560 646 50524909
Meningitis 11.53 9.53 28 79541 6093 50519462
Hospitalisation 11.48 9.53 160 79409 67777 50457778
Epidural haemorrhage 11.34 9.53 5 79564 121 50525434
Inability to afford medication 11.34 9.53 13 79556 1517 50524038
Fear-related avoidance of activities 11.30 9.53 5 79564 122 50525433
Intraocular pressure increased 11.22 9.53 26 79543 5490 50520065
Chemical burn 11.15 9.53 7 79562 354 50525201
Injection site oedema 11.10 9.53 11 79558 1087 50524468
Knee arthroplasty 11.05 9.53 25 79544 35821 50489734
Injection site ischaemia 11.02 9.53 3 79566 15 50525540
Arthritis fungal 11.02 9.53 3 79566 15 50525540
Blepharoplasty 11.02 9.53 3 79566 15 50525540
Coccygectomy 11.02 9.53 3 79566 15 50525540
Chorea 10.98 9.53 12 79557 1328 50524227
Blood pressure immeasurable 10.98 9.53 11 79558 1101 50524454
Procedural pain 10.97 9.53 47 79522 13785 50511770
Procedural haemorrhage 10.94 9.53 16 79553 2374 50523181
Left ventricle outflow tract obstruction 10.88 9.53 6 79563 238 50525317
Decreased appetite 10.84 9.53 237 79332 200686 50324869
Influenza like illness 10.82 9.53 138 79431 57321 50468234
Psoriasis 10.73 9.53 64 79505 68936 50456619
Syringomyelia 10.70 9.53 5 79564 139 50525416
Thrombocytopenia 10.68 9.53 139 79430 127534 50398021
Foreign body in respiratory tract 10.61 9.53 6 79563 250 50525305
Retinal scar 10.60 9.53 5 79564 142 50525413
Anorgasmia 10.60 9.53 8 79561 547 50525008
Septic shock 10.58 9.53 50 79519 57125 50468430
Cystoid macular oedema 10.56 9.53 12 79557 1387 50524168
Granulomatous liver disease 10.54 9.53 9 79560 734 50524821
Myxoedema coma 10.51 9.53 7 79562 392 50525163
Blood methaemoglobin present 10.48 9.53 4 79565 66 50525489
Delayed recovery from anaesthesia 10.48 9.53 9 79560 740 50524815
Type IV hypersensitivity reaction 10.48 9.53 16 79553 2466 50523089
Product preparation error 10.47 9.53 22 79547 4350 50521205
Cerebral congestion 10.42 9.53 3 79566 19 50525536
Apnoeic attack 10.42 9.53 6 79563 259 50525296
Haemorrhagic vasculitis 10.32 9.53 4 79565 69 50525486
Application site pruritus 10.29 9.53 20 79549 3739 50521816
Jaundice 10.29 9.53 16 79553 26413 50499142
Retinal cyst 10.27 9.53 4 79565 70 50525485
Vascular stenosis 10.25 9.53 6 79563 267 50525288
Pallor 10.22 9.53 67 79502 23132 50502423
Repetitive strain injury 10.20 9.53 5 79564 155 50525400
Adverse event 10.16 9.53 35 79534 43728 50481827
Application site pain 10.15 9.53 20 79549 3778 50521777
Cystitis 10.14 9.53 111 79458 44453 50481102
Administration site bruise 10.13 9.53 6 79563 273 50525282
Spinal operation 10.09 9.53 27 79542 6233 50519322
Ophthalmological examination abnormal 10.06 9.53 4 79565 74 50525481
Tumour pain 10.06 9.53 11 79558 1219 50524336
Gastrointestinal bacterial overgrowth 10.02 9.53 7 79562 424 50525131
Gastroenteritis viral 10.01 9.53 57 79512 18729 50506826
Vitreous haemorrhage 9.95 9.53 13 79556 1735 50523820
Therapeutic product effect increased 9.94 9.53 10 79559 1006 50524549
Neuromuscular blockade 9.92 9.53 6 79563 284 50525271
Intercepted medication error 9.91 9.53 7 79562 432 50525123
Dysarthria 9.86 9.53 96 79473 37307 50488248
Electrocardiogram ST segment depression 9.83 9.53 16 79553 2604 50522951
Femoral nerve injury 9.82 9.53 3 79566 24 50525531
Vision blurred 9.80 9.53 176 79393 78471 50447084
Mycobacterium chelonae infection 9.79 9.53 7 79562 440 50525115
Infusion site discolouration 9.79 9.53 8 79561 614 50524941
Hypocalcaemia 9.73 9.53 17 79552 26799 50498756
Disease progression 9.72 9.53 100 79469 95766 50429789
Abdominal pain 9.70 9.53 290 79279 235938 50289617
Vascular malformation 9.68 9.53 6 79563 297 50525258
Injection site abscess 9.67 9.53 10 79559 1039 50524516
Neurogenic shock 9.66 9.53 6 79563 298 50525257
Skin discolouration 9.60 9.53 86 79483 32671 50492884
Transferrin decreased 9.59 9.53 5 79564 177 50525378
Orthostatic hypotension 9.55 9.53 20 79549 29461 50496094

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
Product adhesion issue 403.49 10.42 129 42429 1342 29530627
Anaphylactic shock 231.29 10.42 175 42383 13161 29518808
Anaphylactic reaction 214.28 10.42 230 42328 27343 29504626
Methaemoglobinaemia 200.90 10.42 91 42467 2580 29529389
Anaesthetic complication 196.61 10.42 68 42490 918 29531051
Product quality issue 149.54 10.42 147 42411 15748 29516221
Cardiac arrest 131.01 10.42 342 42216 85249 29446720
Toxic anterior segment syndrome 123.65 10.42 49 42509 987 29530982
Ventricular tachycardia 107.56 10.42 147 42411 22427 29509542
Hypotension 93.12 10.42 536 42022 193818 29338151
Local anaesthetic systemic toxicity 92.04 10.42 26 42532 169 29531800
Sinusitis 87.13 10.42 168 42390 34182 29497787
Lagophthalmos 83.80 10.42 21 42537 79 29531890
Fear 75.04 10.42 80 42478 9424 29522545
Injury 73.15 10.42 112 42446 18934 29513035
Generalised tonic-clonic seizure 64.48 10.42 106 42452 19033 29512936
Renal injury 63.68 10.42 76 42482 10126 29521843
Emotional distress 58.05 10.42 85 42473 13810 29518159
Anhedonia 57.53 10.42 61 42497 7139 29524830
Drug ineffective for unapproved indication 56.58 10.42 85 42473 14129 29517840
Ventricular fibrillation 55.11 10.42 89 42469 15744 29516225
Unresponsive to stimuli 54.29 10.42 115 42443 25011 29506958
Bradycardia 50.82 10.42 208 42350 65421 29466548
Infusion site pain 45.49 10.42 36 42522 2889 29529080
Pain 45.29 10.42 410 42148 171022 29360947
Toxicity to various agents 45.21 10.42 414 42144 173247 29358722
Electrocardiogram ST segment elevation 44.96 10.42 43 42515 4449 29527520
Anaesthetic complication neurological 44.56 10.42 17 42541 308 29531661
Endophthalmitis 44.18 10.42 35 42523 2813 29529156
Unevaluable event 42.26 10.42 116 42442 29735 29502234
Bronchospasm 41.91 10.42 60 42498 9549 29522420
Embolia cutis medicamentosa 40.47 10.42 14 42544 189 29531780
Tachycardia 38.73 10.42 206 42352 72204 29459765
Sinus tachycardia 38.55 10.42 74 42484 14995 29516974
Therapy interrupted 37.52 10.42 53 42505 8333 29523636
Spinal cord infarction 36.18 10.42 14 42544 264 29531705
Ear infection 35.95 10.42 51 42507 8049 29523920
Infusion site swelling 35.67 10.42 26 42532 1844 29530125
Completed suicide 35.18 10.42 47 42511 90199 29441770
Mydriasis 34.20 10.42 43 42515 6042 29525927
Wrong product administered 33.76 10.42 37 42521 4494 29527475
Circulatory collapse 33.10 10.42 79 42479 18594 29513375
Respiratory arrest 32.29 10.42 96 42462 25737 29506232
Ventricular extrasystoles 32.17 10.42 56 42502 10526 29521443
General physical health deterioration 32.15 10.42 62 42496 102795 29429174
Retinal artery occlusion 31.95 10.42 23 42535 1600 29530369
Corneal oedema 31.63 10.42 20 42538 1122 29530847
Removal of foreign body 31.49 10.42 7 42551 13 29531956
Oculocardiac reflex 31.41 10.42 9 42549 62 29531907
Infusion site extravasation 29.54 10.42 29 42529 3098 29528871
Neurotoxicity 29.41 10.42 65 42493 14548 29517421
Delayed recovery from anaesthesia 28.77 10.42 16 42542 707 29531262
Intracranial hypotension 28.40 10.42 11 42547 208 29531761
Electrocardiogram QRS complex prolonged 27.95 10.42 32 42526 4078 29527891
Apnoea 27.94 10.42 39 42519 6063 29525906
Accidental overdose 27.56 10.42 71 42487 17522 29514447
Diarrhoea 27.37 10.42 327 42231 332371 29199598
Blindness 25.93 10.42 55 42503 11968 29520001
Drug ineffective 25.81 10.42 694 41864 362476 29169493
Anal sphincter atony 24.78 10.42 8 42550 86 29531883
Anxiety 24.47 10.42 208 42350 85157 29446812
Foreign body 24.13 10.42 16 42542 974 29530995
Shock 23.47 10.42 76 42482 21328 29510641
Stress 23.29 10.42 76 42482 21414 29510555
Reperfusion arrhythmia 22.89 10.42 7 42551 62 29531907
Administration site pain 22.77 10.42 9 42549 180 29531789
Cardiotoxicity 22.74 10.42 31 42527 4713 29527256
Amaurosis 22.72 10.42 13 42545 607 29531362
Weight decreased 22.67 10.42 126 42432 150779 29381190
Ophthalmoplegia 22.57 10.42 19 42539 1663 29530306
Cyanosis 22.54 10.42 50 42508 11217 29520752
Procedural complication 21.73 10.42 28 42530 4032 29527937
Paraplegia 21.19 10.42 22 42536 2512 29529457
Haemodynamic instability 21.08 10.42 40 42518 8033 29523936
Overdose 21.06 10.42 191 42367 79628 29452341
Diabetes mellitus 20.92 10.42 16 42542 39815 29492154
Respiratory depression 20.59 10.42 54 42504 13469 29518500
Interstitial lung disease 20.57 10.42 32 42526 57686 29474283
Hypoxic-ischaemic encephalopathy 20.54 10.42 28 42530 4256 29527713
Electrocardiogram T wave amplitude increased 20.27 10.42 6 42552 47 29531922
Hypoxia 20.22 10.42 127 42431 47252 29484717
Drug intolerance 20.08 10.42 24 42534 48355 29483614
Anaphylactoid shock 19.86 10.42 10 42548 360 29531609
Seizure 19.79 10.42 213 42345 92910 29439059
Post procedural complication 19.55 10.42 45 42513 10344 29521625
Incorrect route of product administration 19.47 10.42 46 42512 10755 29521214
Loss of consciousness 19.43 10.42 177 42381 73879 29458090
Infusion site bruising 19.39 10.42 10 42548 379 29531590
Cauda equina syndrome 19.20 10.42 10 42548 387 29531582
Acute kidney injury 19.08 10.42 268 42290 264999 29266970
Drug interaction 18.98 10.42 187 42371 197198 29334771
Tryptase increased 18.89 10.42 8 42550 192 29531777
Atrioventricular block complete 18.86 10.42 38 42520 7973 29523996
Blood pressure decreased 18.85 10.42 121 42437 45356 29486613
Infusion site erythema 18.72 10.42 17 42541 1647 29530322
Infusion site haemorrhage 18.43 10.42 12 42546 708 29531261
Retinal vasculitis 18.11 10.42 9 42549 315 29531654
COVID-19 immunisation 17.85 10.42 7 42551 137 29531832
Hyperthermia malignant 17.71 10.42 17 42541 1767 29530202
Miosis 17.69 10.42 37 42521 7972 29523997
Catecholamine crisis 17.51 10.42 5 42553 34 29531935
Vitreous floaters 17.45 10.42 22 42536 3099 29528870
Infusion site nodule 17.08 10.42 6 42552 85 29531884
Tracheitis 16.85 10.42 11 42547 652 29531317
Vitreous disorder 16.83 10.42 6 42552 89 29531880
Aqueous fibrin 16.80 10.42 5 42553 40 29531929
Pulse absent 16.78 10.42 28 42530 5085 29526884
Application site alopecia 16.64 10.42 3 42555 0 29531969
Cytokine release syndrome 16.63 10.42 49 42509 13070 29518899
Trigemino-cardiac reflex 16.37 10.42 7 42551 172 29531797
Chemical burn 16.19 10.42 7 42551 177 29531792
Administration site swelling 16.19 10.42 7 42551 177 29531792
Anterior chamber cell 16.05 10.42 8 42550 282 29531687
Diabetic retinal oedema 15.97 10.42 7 42551 183 29531786
Procedural haemorrhage 15.90 10.42 18 42540 2265 29529704
Melaena 15.77 10.42 13 42545 31163 29500806
Otospondylomegaepiphyseal dysplasia 15.76 10.42 6 42552 108 29531861
Chondrolysis 15.66 10.42 6 42552 110 29531859
Tonic convulsion 15.59 10.42 12 42546 924 29531045
Myopathy toxic 15.58 10.42 9 42549 428 29531541
Infusion site irritation 15.40 10.42 7 42551 200 29531769
Phaeochromocytoma crisis 15.22 10.42 5 42553 57 29531912
Product contamination microbial 15.19 10.42 10 42548 601 29531368
Blood pressure fluctuation 14.91 10.42 5 42553 19889 29512080
Hepatic enzyme increased 14.86 10.42 16 42542 33783 29498186
Diplopia 14.82 10.42 48 42510 13470 29518499
Conjunctival scar 14.77 10.42 5 42553 63 29531906
Administration site reaction 14.77 10.42 5 42553 63 29531906
Myocardial infarction 14.50 10.42 96 42462 110200 29421769
Psoriasis 14.46 10.42 15 42543 32212 29499757
Haemoglobin decreased 14.41 10.42 94 42464 108281 29423688
Arthritis infective 14.37 10.42 19 42539 2805 29529164
Status epilepticus 14.34 10.42 41 42517 10753 29521216
Injection site joint infection 14.29 10.42 4 42554 25 29531944
Adrenergic syndrome 14.29 10.42 5 42553 70 29531899
Decreased appetite 14.25 10.42 137 42421 145205 29386764
Hyperaesthesia 14.17 10.42 21 42537 3448 29528521
Type I hypersensitivity 14.16 10.42 12 42546 1060 29530909
Blood methaemoglobin present 14.16 10.42 4 42554 26 29531943
Infusion site pruritus 14.12 10.42 9 42549 512 29531457
Vitritis 14.05 10.42 10 42548 683 29531286
Procedural hypotension 13.94 10.42 11 42547 879 29531090
Pancreatitis acute 13.85 10.42 9 42549 24376 29507593
Cardiac procedure complication 13.83 10.42 6 42552 153 29531816
Agranulocytosis 13.77 10.42 6 42552 20334 29511635
Angina pectoris 13.62 10.42 12 42546 27838 29504131
Administration related reaction 13.56 10.42 5 42553 82 29531887
Hypoglycaemia 13.53 10.42 31 42527 48315 29483654
Leukopenia 13.44 10.42 38 42520 55165 29476804
Oral lichen planus 13.41 10.42 6 42552 165 29531804
Myokymia 13.29 10.42 5 42553 87 29531882
Oesophageal obstruction 13.25 10.42 8 42550 413 29531556
Laryngeal oedema 13.24 10.42 19 42539 3029 29528940
Skin infection 13.09 10.42 29 42529 6498 29525471
Surgery 13.07 10.42 42 42516 11737 29520232
Brain oedema 13.04 10.42 43 42515 12177 29519792
Testicular torsion 13.03 10.42 3 42555 7 29531962
Therapy cessation 12.93 10.42 48 42510 14414 29517555
Extradural abscess 12.93 10.42 9 42549 593 29531376
Eye inflammation 12.90 10.42 14 42544 1682 29530287
Sleep deficit 12.86 10.42 8 42550 436 29531533
Burkholderia test positive 12.82 10.42 11 42547 988 29530981
Allodynia 12.79 10.42 9 42549 604 29531365
Jaundice 12.73 10.42 14 42544 29282 29502687
Anaemia 12.72 10.42 208 42350 200743 29331226
Opisthotonus 12.70 10.42 8 42550 446 29531523
Hepatotoxicity 12.53 10.42 5 42553 17862 29514107
Application site irritation 12.51 10.42 9 42549 625 29531344
Neuromuscular blockade 12.48 10.42 6 42552 195 29531774
Cerebral venous thrombosis 12.46 10.42 9 42549 629 29531340
Drug-induced liver injury 12.29 10.42 8 42550 21647 29510322
Anal ulcer 12.21 10.42 9 42549 649 29531320
Inadequate analgesia 12.21 10.42 17 42541 2637 29529332
Erythema 12.14 10.42 164 42394 75442 29456527
Upper respiratory tract infection 12.10 10.42 74 42484 27275 29504694
Hypopyon 12.08 10.42 7 42551 335 29531634
Suicide attempt 12.06 10.42 19 42539 34091 29497878
Application site erythema 12.06 10.42 15 42543 2084 29529885
Kounis syndrome 12.03 10.42 14 42544 1815 29530154
Administration site irritation 12.03 10.42 3 42555 11 29531958
International normalised ratio increased 11.98 10.42 29 42529 44343 29487626
Induration 11.97 10.42 10 42548 866 29531103
Spinal operation 11.91 10.42 16 42542 2398 29529571
Coronary artery disease 11.83 10.42 29 42529 44161 29487808
Injection site extravasation 11.82 10.42 16 42542 2417 29529552
Symblepharon 11.77 10.42 5 42553 121 29531848
Spinal cord injury 11.71 10.42 7 42551 355 29531614
Penile vascular disorder 11.63 10.42 3 42555 13 29531956
Oxygen saturation decreased 11.57 10.42 107 42451 44830 29487139
Pulmonary fibrosis 11.53 10.42 4 42554 15578 29516391
Posterior capsule rupture 11.45 10.42 3 42555 14 29531955
Macroglossia 11.38 10.42 7 42551 374 29531595
Palatal oedema 11.37 10.42 9 42549 722 29531247
Chondromalacia 11.28 10.42 3 42555 15 29531954
Injection site ulcer 11.25 10.42 6 42552 244 29531725
Fear of eating 11.24 10.42 4 42554 59 29531910
Infusion site reaction 11.23 10.42 9 42549 735 29531234
Mean arterial pressure decreased 11.16 10.42 5 42553 138 29531831
Condition aggravated 11.14 10.42 146 42412 146149 29385820
Sinus arrest 11.10 10.42 12 42546 1435 29530534
Oxidative stress 11.06 10.42 4 42554 62 29531907
Respiratory paralysis 11.00 10.42 4 42554 63 29531906
Myalgia 10.99 10.42 62 42496 73957 29458012
Foreign body in respiratory tract 10.96 10.42 5 42553 144 29531825
Hypotonia 10.96 10.42 28 42530 6874 29525095
Vitreous detachment 10.95 10.42 9 42549 762 29531207
Drug resistance 10.87 10.42 9 42549 21531 29510438
Sinus bradycardia 10.79 10.42 39 42519 11564 29520405
Tubulointerstitial nephritis 10.74 10.42 6 42552 17637 29514332
Coma 10.70 10.42 95 42463 39355 29492614
Ocular retrobulbar haemorrhage 10.69 10.42 3 42555 19 29531950
Urticaria 10.67 10.42 123 42435 54537 29477432
Retrognathia 10.57 10.42 6 42552 276 29531693
Croup infectious 10.49 10.42 6 42552 280 29531689
Arthritis bacterial 10.47 10.42 21 42537 4392 29527577

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
Product adhesion issue 708.34 9.44 225 94598 2234 64401675
Local anaesthetic systemic toxicity 430.93 9.44 115 94708 570 64403339
Anaphylactic shock 399.84 9.44 342 94481 29986 64373923
Anaphylactic reaction 381.11 9.44 487 94336 68177 64335732
Anaesthetic complication 376.37 9.44 142 94681 2437 64401472
Toxic anterior segment syndrome 369.42 9.44 138 94685 2301 64401608
Cardiac arrest 302.92 9.44 687 94136 153377 64250532
Product quality issue 268.75 9.44 272 94551 29527 64374382
Lagophthalmos 234.91 9.44 62 94761 292 64403617
Methaemoglobinaemia 220.90 9.44 114 94709 4234 64399675
Completed suicide 148.68 9.44 72 94751 224342 64179567
Ventricular tachycardia 137.46 9.44 208 94615 34057 64369852
Hypotension 125.93 9.44 974 93849 380000 64023909
Unresponsive to stimuli 112.82 9.44 237 94586 50156 64353753
Bradycardia 111.71 9.44 405 94418 117814 64286095
Generalised tonic-clonic seizure 110.44 9.44 205 94618 39652 64364257
Therapy interrupted 107.75 9.44 140 94683 19896 64384013
Drug intolerance 105.08 9.44 74 94749 187918 64215991
Fear 100.85 9.44 136 94687 20035 64383874
Corneal oedema 98.08 9.44 54 94769 2289 64401620
Synovitis 90.13 9.44 18 94805 99072 64304837
Renal injury 89.58 9.44 112 94711 15317 64388592
Contraindicated product administered 89.31 9.44 24 94799 107805 64296104
Incorrect route of product administration 88.61 9.44 138 94685 23160 64380749
Anaesthetic complication neurological 86.80 9.44 32 94791 513 64403396
Stress cardiomyopathy 84.35 9.44 85 94738 9172 64394737
Pulseless electrical activity 81.29 9.44 97 94726 12642 64391267
General physical health deterioration 81.18 9.44 109 94714 204316 64199593
Hepatic enzyme increased 81.09 9.44 45 94778 129898 64274011
Anhedonia 80.38 9.44 100 94723 13606 64390303
Injury 79.68 9.44 221 94602 55771 64348138
Joint swelling 79.45 9.44 121 94702 215261 64188648
Ventricular fibrillation 79.39 9.44 133 94690 23727 64380182
Hand deformity 79.05 9.44 3 94820 62768 64341141
Extradural abscess 77.64 9.44 37 94786 1154 64402755
Drug ineffective for unapproved indication 76.27 9.44 152 94671 30981 64372928
Emotional distress 75.49 9.44 165 94658 35873 64368036
Bronchospasm 75.01 9.44 123 94700 21559 64382350
Endophthalmitis 73.74 9.44 62 94761 5303 64398606
Maternal exposure during delivery 71.61 9.44 32 94791 858 64403051
Seizure 69.74 9.44 452 94371 166440 64237469
Pulse absent 68.74 9.44 75 94748 8871 64395038
Unevaluable event 67.65 9.44 195 94628 50294 64353615
Pemphigus 67.08 9.44 6 94817 60695 64343214
Cauda equina syndrome 65.06 9.44 32 94791 1071 64402838
Type I hypersensitivity 63.45 9.44 48 94775 3526 64400383
Apnoea 62.66 9.44 77 94746 10345 64393564
Body tinea 60.26 9.44 32 94791 1261 64402648
Systemic lupus erythematosus 59.32 9.44 20 94803 77592 64326317
Procedural hypotension 59.07 9.44 36 94787 1850 64402059
Ophthalmoplegia 58.68 9.44 41 94782 2661 64401248
Retinal artery occlusion 58.31 9.44 42 94781 2861 64401048
Rheumatoid arthritis 57.07 9.44 96 94727 164198 64239711
Sinus tachycardia 56.00 9.44 137 94686 32051 64371858
Toxicity to various agents 55.92 9.44 796 94027 362717 64041192
Pericarditis 55.51 9.44 12 94811 62504 64341405
Tachycardia 55.25 9.44 393 94430 149186 64254723
Retinal vasculitis 55.19 9.44 29 94794 1118 64402791
Embolia cutis medicamentosa 53.73 9.44 22 94801 473 64403436
Infusion site swelling 53.16 9.44 52 94771 5413 64398496
Vitritis 52.52 9.44 31 94792 1502 64402407
Neurotoxicity 51.29 9.44 120 94703 27284 64376625
Post procedural complication 50.80 9.44 103 94720 21250 64382659
Diarrhoea 50.74 9.44 753 94070 721951 63681958
Glossodynia 50.63 9.44 16 94807 64680 64339229
Hypopyon 49.46 9.44 26 94797 1003 64402906
Anterior chamber cell 48.89 9.44 24 94799 800 64403109
Arthralgia 48.70 9.44 416 94407 441844 63962065
Sensory loss 48.46 9.44 67 94756 10102 64393807
Mydriasis 47.83 9.44 83 94740 15229 64388680
Removal of foreign body 47.76 9.44 11 94812 25 64403884
Extradural haematoma 47.64 9.44 36 94787 2640 64401269
Spinal cord infarction 47.35 9.44 21 94802 553 64403356
Infusion site erythema 46.62 9.44 54 94769 6819 64397090
Abdominal discomfort 45.54 9.44 128 94695 182194 64221715
Anaphylactoid shock 44.85 9.44 22 94801 732 64403177
Blood pressure decreased 44.64 9.44 247 94576 85952 64317957
Cyanosis 43.65 9.44 99 94724 22056 64381853
Accidental overdose 43.40 9.44 128 94695 33429 64370480
Therapy cessation 43.05 9.44 125 94698 32364 64371545
Respiratory arrest 42.98 9.44 173 94650 52812 64351097
Sinusitis 42.56 9.44 363 94460 145565 64258344
Circulatory collapse 42.05 9.44 127 94696 33605 64370304
Aqueous fibrin 41.76 9.44 13 94810 120 64403789
Shock 41.28 9.44 137 94686 38103 64365806
Procedural complication 41.00 9.44 52 94771 7213 64396696
Fear of eating 40.18 9.44 17 94806 398 64403511
Arthropathy 39.90 9.44 73 94750 120894 64283015
Suicide attempt 39.58 9.44 28 94795 70979 64332930
Arthritis bacterial 39.40 9.44 53 94770 7786 64396123
Myopathy toxic 39.25 9.44 21 94802 840 64403069
Mental status changes 39.16 9.44 186 94637 60976 64342933
Paraplegia 38.67 9.44 40 94783 4450 64399459
Infection susceptibility increased 38.49 9.44 32 94791 2694 64401215
Tryptase increased 38.42 9.44 17 94806 445 64403464
Surgery 37.82 9.44 109 94714 28104 64375805
Paralysis 37.73 9.44 64 94759 11531 64392378
Infusion site pruritus 37.65 9.44 31 94792 2575 64401334
Kounis syndrome 37.59 9.44 33 94790 2992 64400917
Nerve root injury 37.28 9.44 9 94814 27 64403882
Acute kidney injury 37.27 9.44 452 94371 448788 63955121
Anal sphincter atony 37.18 9.44 15 94808 310 64403599
Acute motor-sensory axonal neuropathy 36.99 9.44 16 94807 396 64403513
Wound 36.62 9.44 35 94788 76442 64327467
Diplopia 36.45 9.44 104 94719 26661 64377248
Product contamination microbial 36.00 9.44 20 94803 863 64403046
Respiratory depression 35.81 9.44 95 94728 23348 64380561
Status epilepticus 35.36 9.44 90 94733 21573 64382336
Ventricular extrasystoles 35.28 9.44 79 94744 17450 64386459
Alopecia 35.27 9.44 125 94698 165565 64238344
Delayed recovery from anaesthesia 35.10 9.44 24 94799 1504 64402405
Trigemino-cardiac reflex 34.03 9.44 13 94810 231 64403678
Loss of consciousness 33.25 9.44 349 94474 148016 64255893
Peripheral nerve injury 33.24 9.44 17 94806 619 64403290
Hypoxia 32.75 9.44 232 94591 87917 64315992
Therapeutic product effect decreased 32.63 9.44 76 94747 115275 64288634
Meningitis chemical 32.46 9.44 12 94811 194 64403715
Lower respiratory tract infection 32.18 9.44 56 94767 94558 64309351
Platelet aggregation inhibition 32.16 9.44 11 94812 140 64403769
Infusion site pain 32.01 9.44 56 94767 10341 64393568
Application site rash 31.97 9.44 25 94798 1929 64401980
Electrocardiogram ST segment elevation 31.89 9.44 46 94777 7213 64396696
Visual acuity reduced 31.80 9.44 100 94723 27041 64376868
Intentional self-injury 31.74 9.44 3 94820 29041 64374868
Spinal anaesthesia 31.22 9.44 9 94814 62 64403847
Oculocardiac reflex 31.22 9.44 9 94814 62 64403847
Inhibitory drug interaction 30.68 9.44 32 94791 3595 64400314
Incorrect drug administration rate 30.50 9.44 28 94795 2691 64401218
Pneumocephalus 30.43 9.44 12 94811 233 64403676
Anaphylactoid reaction 30.10 9.44 36 94787 4702 64399207
Sopor 30.06 9.44 4 94819 29657 64374252
Anxiety 30.00 9.44 441 94382 202208 64201701
Upper airway obstruction 29.47 9.44 20 94803 1238 64402671
Nystagmus 29.43 9.44 50 94773 9018 64394891
Corneal epithelium defect 29.26 9.44 16 94807 669 64403240
Foreign body 28.73 9.44 26 94797 2453 64401456
Electrocardiogram QRS complex prolonged 28.73 9.44 50 94773 9194 64394715
Nerve block 28.64 9.44 13 94810 362 64403547
Impaired quality of life 28.41 9.44 41 94782 6430 64397479
Lactic acidosis 28.37 9.44 29 94794 61381 64342528
Wrong product administered 28.34 9.44 45 94778 7675 64396234
Amaurosis 27.85 9.44 18 94805 1026 64402883
Cardiotoxicity 27.40 9.44 52 94771 10222 64393687
Musculoskeletal stiffness 26.85 9.44 92 94731 123114 64280795
Intracranial hypotension 26.11 9.44 12 94811 344 64403565
Miosis 25.82 9.44 59 94764 13207 64390702
Blindness 25.68 9.44 81 94742 21938 64381971
Bursitis infective 25.57 9.44 18 94805 1182 64402727
Sleep disorder due to general medical condition, insomnia type 25.56 9.44 4 94819 26266 64377643
Staphylococcal infection 25.42 9.44 144 94679 50534 64353375
Infusion site extravasation 25.30 9.44 40 94783 6797 64397112
Drug resistance 25.20 9.44 10 94813 35092 64368817
Interstitial lung disease 24.84 9.44 68 94755 97664 64306245
Systemic toxicity 24.78 9.44 8 94815 84 64403825
Neutropenia 24.73 9.44 229 94594 239395 64164514
Drug reaction with eosinophilia and systemic symptoms 24.60 9.44 26 94797 54191 64349718
Asthenia 24.36 9.44 463 94360 427581 63976328
Neuromuscular block prolonged 24.01 9.44 16 94807 961 64402948
Death 23.94 9.44 901 93922 481804 63922105
Mobility decreased 23.92 9.44 57 94766 85783 64318126
Eyelid ptosis 23.92 9.44 47 94776 9478 64394431
Infusion site bruising 23.77 9.44 19 94804 1513 64402396
Parophthalmia 23.41 9.44 11 94812 332 64403577
Punctate keratitis 23.29 9.44 15 94808 850 64403059
Hepatotoxicity 23.28 9.44 15 94808 39947 64363962
Chemical burn 23.26 9.44 12 94811 445 64403464
COVID-19 immunisation 23.25 9.44 13 94810 568 64403341
Spinal cord oedema 23.08 9.44 11 94812 343 64403566
Glucose tolerance impaired 22.89 9.44 37 94786 6406 64397503
Laryngeal oedema 22.80 9.44 39 94784 7074 64396835
Dermatitis contact 22.11 9.44 44 94779 8956 64394953
Aspiration joint abnormal 22.10 9.44 4 94819 0 64403909
Neuromuscular blockade 21.94 9.44 12 94811 502 64403407
Procedural haemorrhage 21.76 9.44 29 94794 4223 64399686
Inadequate analgesia 21.70 9.44 28 94795 3950 64399959
Stridor 21.57 9.44 31 94792 4843 64399066
Infusion site mass 21.57 9.44 15 94808 966 64402943
Product preparation error 21.55 9.44 28 94795 3977 64399932
Arthritis 21.54 9.44 58 94765 83756 64320153
Application site alopecia 21.52 9.44 5 94818 12 64403897
Pulmonary oedema 21.51 9.44 193 94630 78481 64325428
Haemodynamic instability 21.34 9.44 59 94764 14853 64389056
C-reactive protein abnormal 21.31 9.44 8 94815 29039 64374870
Nasopharyngitis 21.27 9.44 185 94638 195888 64208021
Blood pressure fluctuation 21.24 9.44 27 94796 51844 64352065
Atonic urinary bladder 21.15 9.44 7 94816 80 64403829
Phrenic nerve paralysis 20.95 9.44 9 94814 219 64403690
Folliculitis 20.90 9.44 9 94814 30068 64373841
Spinal epidural haemorrhage 20.75 9.44 8 94815 146 64403763
COVID-19 20.56 9.44 165 94658 64975 64338934
Spinal epidural haematoma 20.56 9.44 16 94807 1226 64402683
Airway peak pressure increased 20.55 9.44 10 94813 327 64403582
Leukopenia 20.47 9.44 78 94745 101164 64302745
Allodynia 20.10 9.44 16 94807 1267 64402642
Pancreatitis acute 20.06 9.44 20 94803 42835 64361074
Abortion spontaneous 20.06 9.44 6 94817 25137 64378772
Foreign body in respiratory tract 20.02 9.44 10 94813 346 64403563
Treatment failure 19.93 9.44 96 94727 116720 64287189
Muscle injury 19.87 9.44 7 94816 26430 64377479
Trigeminal palsy 19.80 9.44 5 94818 19 64403890
Atrioventricular block complete 19.61 9.44 56 94767 14362 64389547
Sinus bradycardia 19.57 9.44 76 94747 22817 64381092
Cytokine release syndrome 19.34 9.44 71 94752 20758 64383151
Weight decreased 19.16 9.44 300 94523 285439 64118470
Harlequin syndrome 19.12 9.44 6 94817 57 64403852
Opisthotonus 18.97 9.44 12 94811 659 64403250
Decreased appetite 18.97 9.44 295 94528 280994 64122915
Glossoptosis 18.96 9.44 8 94815 186 64403723
Pupillary reflex impaired 18.95 9.44 23 94800 3050 64400859
Infusion related reaction 18.82 9.44 153 94670 164314 64239595
Hypoaesthesia oral 18.78 9.44 48 94775 11532 64392377
Upper respiratory tract infection 18.61 9.44 176 94647 72609 64331300
Skin test positive 18.38 9.44 14 94809 1039 64402870
Tracheal deviation 18.33 9.44 6 94817 66 64403843
Septic arthritis staphylococcal 18.32 9.44 12 94811 700 64403209
Intentional dose omission 18.13 9.44 31 94792 5621 64398288
Poor quality product administered 18.12 9.44 23 94800 3192 64400717
Jaundice 18.10 9.44 27 94796 48485 64355424
Injection site joint infection 18.08 9.44 5 94818 29 64403880
Overdose 17.94 9.44 332 94491 159234 64244675
Melaena 17.93 9.44 32 94791 53516 64350393
Hospitalisation 17.83 9.44 179 94644 75028 64328881
Hypoxic-ischaemic encephalopathy 17.61 9.44 35 94788 7117 64396792
Chorea 17.56 9.44 18 94805 1982 64401927
Corneal abrasion 17.42 9.44 13 94810 935 64402974
Catecholamine crisis 17.40 9.44 5 94818 34 64403875
Pallor 17.39 9.44 107 94716 38674 64365235
Stress 17.32 9.44 150 94673 60384 64343525
Mean arterial pressure decreased 17.29 9.44 9 94814 340 64403569
Psoriatic arthropathy 17.23 9.44 23 94800 43258 64360651
Respiratory acidosis 17.19 9.44 42 94781 9813 64394096
Abdominal pain 17.10 9.44 340 94483 312035 64091874
Poor quality sleep 17.09 9.44 64 94759 18887 64385022
Infusion site haemorrhage 17.08 9.44 19 94804 2296 64401613
Hypoglycaemia 17.06 9.44 71 94752 89821 64314088
Familial periodic paralysis 17.03 9.44 7 94816 152 64403757
Vitreous disorder 17.01 9.44 8 94815 242 64403667
Type IV hypersensitivity reaction 16.99 9.44 23 94800 3399 64400510
Diplegia 16.94 9.44 16 94807 1595 64402314
Liver function test abnormal 16.90 9.44 39 94784 59362 64344547
Foetal heart rate abnormal 16.83 9.44 8 94815 248 64403661
Ventricular hypokinesia 16.75 9.44 36 94787 7733 64396176
Spinal cord compression 16.63 9.44 30 94793 5673 64398236
Carotid pulse decreased 16.57 9.44 3 94820 0 64403909
Blepharoplasty 16.57 9.44 3 94820 0 64403909
Removal of foreign body from respiratory tract 16.57 9.44 3 94820 0 64403909
Abdominal pain upper 16.48 9.44 171 94652 174859 64229050
Axillary nerve injury 16.33 9.44 4 94819 13 64403896
Diabetic ketoacidosis 16.32 9.44 12 94811 29833 64374076
Procedural pain 16.24 9.44 55 94768 15453 64388456
Symblepharon 16.23 9.44 7 94816 172 64403737
Meningitis 16.16 9.44 37 94786 8292 64395617
Hyperthermia malignant 16.14 9.44 19 94804 2440 64401469
Quadriplegia 16.11 9.44 21 94802 2992 64400917
Eye inflammation 16.05 9.44 27 94796 4830 64399079
Psoriasis 15.99 9.44 53 94770 71650 64332259
Airway complication of anaesthesia 15.89 9.44 9 94814 403 64403506
Sinus arrest 15.70 9.44 21 94802 3069 64400840
Anal ulcer 15.62 9.44 13 94810 1096 64402813
Apnoeic attack 15.62 9.44 10 94813 561 64403348
Piloerection 15.61 9.44 9 94814 417 64403492
Cellulitis 15.52 9.44 208 94615 93449 64310460
Irregular breathing 15.52 9.44 9 94814 422 64403487
Cholestasis of pregnancy 15.49 9.44 12 94811 913 64402996
Vitreous floaters 15.47 9.44 31 94792 6342 64397567
Pneumonia mycoplasmal 15.46 9.44 14 94809 1322 64402587
Application site erythema 15.41 9.44 26 94797 4663 64399246
Monoplegia 15.39 9.44 22 94801 3421 64400488
Rash 15.33 9.44 536 94287 458013 63945896
Blood pressure systolic increased 15.29 9.44 31 94792 49422 64354487
Neuroleptic malignant syndrome 15.09 9.44 9 94814 24987 64378922
Incision site rash 14.96 9.44 4 94819 20 64403889
Administration site swelling 14.93 9.44 8 94815 321 64403588
Bone density decreased 14.86 9.44 40 94783 9912 64393997
Ear infection 14.85 9.44 71 94752 23333 64380576
Administration related reaction 14.83 9.44 6 94817 125 64403784
Nail bed tenderness 14.82 9.44 8 94815 326 64403583
Myocardial infarction 14.81 9.44 164 94659 165657 64238252
Chondrolysis 14.75 9.44 8 94815 329 64403580
Cardiac failure congestive 14.69 9.44 122 94701 130458 64273451
Impaired healing 14.68 9.44 43 94780 60430 64343479
Coronary artery disease 14.65 9.44 43 94780 60390 64343519
Erythema 14.54 9.44 369 94454 186701 64217208
Retinal haemorrhage 14.51 9.44 33 94790 7365 64396544
Removal of foreign body from throat 14.50 9.44 3 94820 3 64403906
Testicular torsion 14.50 9.44 3 94820 3 64403906
Fatigue 14.49 9.44 928 93895 747802 63656107
Ocular retrobulbar haemorrhage 14.48 9.44 6 94817 133 64403776
Uterine hypertonus 14.46 9.44 7 94816 226 64403683
Disease recurrence 14.42 9.44 15 94808 31495 64372414
Dysarthria 14.37 9.44 142 94681 59264 64344645
Hyponatraemia 14.34 9.44 144 94679 148195 64255714
Rhabdomyolysis 14.17 9.44 78 94745 91648 64312261
Condition aggravated 13.94 9.44 429 94394 371997 64031912
Cough 13.91 9.44 338 94485 301810 64102099
Spinal operation 13.90 9.44 29 94794 6104 64397805
Blood creatinine increased 13.89 9.44 130 94693 135652 64268257
Oxidative stress 13.82 9.44 4 94819 28 64403881
Infusion site nodule 13.79 9.44 7 94816 251 64403658
Body dysmorphic disorder 13.76 9.44 7 94816 252 64403657
Hepatitis 13.73 9.44 29 94794 45553 64358356
Nerve injury 13.67 9.44 33 94790 7652 64396257
Bundle branch block left 13.67 9.44 39 94784 9995 64393914
Thrombocytopenia 13.67 9.44 239 94584 223562 64180347
Application site vesicles 13.65 9.44 13 94810 1309 64402600
Cytomegalovirus infection 13.60 9.44 21 94802 37178 64366731
Agranulocytosis 13.57 9.44 22 94801 38207 64365702
International normalised ratio increased 13.54 9.44 65 94758 79102 64324807
Administration site pain 13.53 9.44 8 94815 389 64403520
Application site oedema 13.51 9.44 5 94818 81 64403828
Gastrointestinal disorder 13.47 9.44 77 94746 89632 64314277
Sleep disorder 13.40 9.44 44 94779 59665 64344244
Air embolism 13.25 9.44 8 94815 404 64403505
Strabismus 13.19 9.44 16 94807 2121 64401788
Angioedema 13.17 9.44 144 94679 61677 64342232
Orthostatic hypotension 13.05 9.44 31 94792 46707 64357202
Spinal cord injury 12.99 9.44 11 94812 950 64402959
Conjunctival scar 12.98 9.44 5 94818 91 64403818
Reperfusion arrhythmia 12.97 9.44 7 94816 285 64403624
Oesophageal adenocarcinoma recurrent 12.94 9.44 4 94819 36 64403873
Therapeutic product effect incomplete 12.89 9.44 94 94729 103388 64300521
Treatment noncompliance 12.82 9.44 28 94795 43454 64360455
Tubulointerstitial nephritis 12.74 9.44 16 94807 30893 64373016
Blood cholesterol increased 12.60 9.44 35 94788 50031 64353878
Peripheral swelling 12.56 9.44 224 94599 208929 64194980
Femoral nerve injury 12.56 9.44 4 94819 40 64403869
Infusion site urticaria 12.51 9.44 9 94814 612 64403297
Drug hypersensitivity 12.50 9.44 447 94376 237368 64166541
Diabetes mellitus 12.31 9.44 53 94770 66421 64337488
Haematochezia 12.24 9.44 53 94770 66320 64337589
Vitamin D increased 12.13 9.44 8 94815 472 64403437
Anaemia 12.11 9.44 445 94378 378235 64025674
Urinary tract infection 12.10 9.44 435 94388 231161 64172748
Aphasia 12.04 9.44 102 94721 40804 64363105
Tracheitis 12.04 9.44 12 94811 1278 64402631
Conjunctival oedema 12.02 9.44 11 94812 1053 64402856
Hypoventilation 12.01 9.44 27 94796 5979 64397930
Myokymia 11.98 9.44 5 94818 113 64403796
Injection site ulcer 11.93 9.44 9 94814 658 64403251
C-reactive protein increased 11.93 9.44 86 94737 94823 64309086
Disease progression 11.91 9.44 142 94681 141538 64262371
Paranasal cyst 11.90 9.44 7 94816 337 64403572
Injection site oedema 11.88 9.44 11 94812 1069 64402840
Hallucination, auditory 11.88 9.44 5 94818 16934 64386975
Hepatocellular injury 11.85 9.44 31 94792 45204 64358705
Muscle rigidity 11.81 9.44 54 94769 17419 64386490
Adrenergic syndrome 11.78 9.44 5 94818 118 64403791
Injection site necrosis 11.77 9.44 12 94811 1313 64402596
Photosensitivity reaction 11.76 9.44 6 94817 18167 64385742
Lumbar spinal stenosis 11.74 9.44 23 94800 4627 64399282
Product contamination physical 11.74 9.44 5 94818 119 64403790
Supraventricular tachycardia 11.74 9.44 57 94766 18850 64385059
Type 2 diabetes mellitus 11.69 9.44 20 94803 34000 64369909
Epidural analgesia 11.69 9.44 4 94819 51 64403858
Arachnoiditis 11.67 9.44 9 94814 680 64403229
Infusion site rash 11.66 9.44 11 94812 1095 64402814
Off label use 11.60 9.44 788 94035 632018 63771891
Corneal opacity 11.50 9.44 10 94813 895 64403014
Device ineffective 11.37 9.44 5 94818 129 64403780
Injection site atrophy 11.31 9.44 7 94816 370 64403539
Product use issue 11.30 9.44 156 94667 151559 64252350
Myelosuppression 11.29 9.44 11 94812 23819 64380090
Arthritis infective 11.26 9.44 29 94794 7001 64396908
Product administered at inappropriate site 11.24 9.44 18 94805 3092 64400817
Coccygectomy 11.22 9.44 3 94820 15 64403894
Respiratory tract oedema 11.21 9.44 9 94814 721 64403188
Induration 11.16 9.44 13 94810 1651 64402258
Spinal cord ischaemia 11.16 9.44 5 94818 135 64403774
Poisoning deliberate 11.13 9.44 3 94820 13455 64390454
Syringomyelia 11.09 9.44 5 94818 137 64403772
Intraocular pressure increased 11.05 9.44 32 94791 8270 64395639
Ill-defined disorder 10.93 9.44 31 94792 44021 64359888
Hyperaesthesia 10.92 9.44 36 94787 9978 64393931
Liver injury 10.84 9.44 17 94806 29915 64373994
Cholestasis 10.83 9.44 32 94791 44840 64359069
Repetitive strain injury 10.80 9.44 5 94818 146 64403763
Delirium 10.78 9.44 152 94671 69042 64334867
Drug-induced liver injury 10.77 9.44 35 94788 47608 64356301
Pain 10.61 9.44 948 93875 552563 63851346
Small intestinal obstruction 10.54 9.44 65 94758 23508 64380401
Orbital infection 10.53 9.44 4 94819 70 64403839
Injection site ischaemia 10.49 9.44 3 94820 20 64403889
Hemiplegic migraine 10.48 9.44 4 94819 71 64403838
Progressive multifocal leukoencephalopathy 10.41 9.44 7 94816 18225 64385684
Agitation 10.33 9.44 185 94638 88182 64315727
Oesophageal obstruction 10.31 9.44 9 94814 810 64403099
Back pain 10.30 9.44 458 94365 249713 64154196
Anterior chamber fibrin 10.20 9.44 5 94818 166 64403743
Pain in extremity 10.18 9.44 354 94469 302731 64101178
Product prescribing error 10.16 9.44 23 94800 35246 64368663
Exophthalmos 10.15 9.44 12 94811 1548 64402361
Product contamination 10.08 9.44 10 94813 1059 64402850
Vascular malformation 10.07 9.44 6 94817 296 64403613
Mycobacterium chelonae infection 10.06 9.44 14 94809 2123 64401786
Electrocardiogram QRS complex shortened 10.05 9.44 8 94815 633 64403276
Macroglossia 10.05 9.44 10 94813 1062 64402847
Genital ulceration 10.03 9.44 8 94815 635 64403274
Non-infectious endophthalmitis 10.01 9.44 6 94817 299 64403610
Underdose 10.01 9.44 14 94809 25815 64378094
Vasoplegia syndrome 9.98 9.44 16 94807 2751 64401158
Epidural haemorrhage 9.96 9.44 5 94818 175 64403734
Blindness transient 9.94 9.44 20 94803 4102 64399807
Loss of personal independence in daily activities 9.92 9.44 64 94759 72390 64331519
Drug level increased 9.92 9.44 85 94738 34111 64369798
Vitreous haze 9.90 9.44 4 94819 83 64403826
Pulmonary fibrosis 9.87 9.44 18 94805 29860 64374049
Propionibacterium infection 9.85 9.44 6 94817 308 64403601
Myopathy 9.81 9.44 7 94816 17673 64386236
Histamine level increased 9.77 9.44 4 94819 86 64403823
Left ventricle outflow tract obstruction 9.76 9.44 6 94817 313 64403596
Vaginal abscess 9.76 9.44 6 94817 313 64403596
Chorioretinopathy 9.76 9.44 14 94809 2183 64401726
Eclampsia 9.75 9.44 5 94818 183 64403726
Respiratory failure 9.75 9.44 308 94515 160875 64243034
Gastroenteritis 9.73 9.44 18 94805 29693 64374216
Haemorrhagic vasculitis 9.73 9.44 4 94819 87 64403822
Pneumocystis jirovecii pneumonia 9.72 9.44 16 94807 27618 64376291
Cardiac procedure complication 9.66 9.44 6 94817 319 64403590
Quadriparesis 9.60 9.44 16 94807 2841 64401068
Seizure like phenomena 9.60 9.44 12 94811 1640 64402269
Urticaria 9.57 9.44 284 94539 147033 64256876
Exposure during pregnancy 9.57 9.44 164 94659 77511 64326398
Myxoedema coma 9.57 9.44 8 94815 679 64403230
Urinary incontinence 9.53 9.44 88 94735 36063 64367846
Swelling 9.49 9.44 172 94651 160046 64243863

FDA Adverse Event Reporting System (Pediatric)

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
Methaemoglobinaemia 67.07 55.90 13 24 64 84577

Pharmacologic Action:

SourceCodeDescription
ATC C01BB01 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
ANTIARRHYTHMICS, CLASS I AND III
Antiarrhythmics, class Ib
ATC C05AD01 CARDIOVASCULAR SYSTEM
VASOPROTECTIVES
AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
Local anesthetics
ATC D04AB01 DERMATOLOGICALS
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
Anesthetics for topical use
ATC N01BB02 NERVOUS SYSTEM
ANESTHETICS
ANESTHETICS, LOCAL
Amides
ATC N01BB52 NERVOUS SYSTEM
ANESTHETICS
ANESTHETICS, LOCAL
Amides
ATC R02AD02 RESPIRATORY SYSTEM
THROAT PREPARATIONS
THROAT PREPARATIONS
Anesthetics, local
ATC S01HA07 SENSORY ORGANS
OPHTHALMOLOGICALS
LOCAL ANESTHETICS
Local anesthetics
ATC S02DA01 SENSORY ORGANS
OTOLOGICALS
OTHER OTOLOGICALS
Analgesics and anesthetics
FDA CS M0000897 Amides
FDA EPC N0000175426 Antiarrhythmic
MeSH PA D000777 Anesthetics
MeSH PA D000779 Anesthetics, Local
MeSH PA D000889 Anti-Arrhythmia Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D026941 Sodium Channel Blockers
MeSH PA D061567 Voltage-Gated Sodium Channel Blockers
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:36333 local anesthetics
CHEBI has role CHEBI:38070 antiarrhythmic agent
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:88188 allergenic drug
FDA EPC N0000175682 Amide Local Anesthetic
FDA PE N0000175976 Local Anesthesia

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Postherpetic neuralgia indication 2177002
Neuralgia indication 16269008
Urethritis indication 31822004 DOID:1343
Premature ejaculation indication 44001008 DOID:13709
Ventricular arrhythmia indication 44103008
Hemorrhoids indication 70153002 DOID:9746
Infestation by Phthirus pubis indication 71011005 DOID:13760
Pediculosis capitis indication 81000006 DOID:5501
Pruritus ani indication 90446007
Infestation by Sarcoptes scabiei var hominis indication 128869009 DOID:8295
Local anesthetic intrathecal block indication 231249005
Skin irritation indication 367466007
Local anesthesia indication 386761002
Itching of skin indication 418363000
Local Anesthesia for Urethral Pain indication
Suppression of the Gag Reflex indication
Local Anesthesia for Ophthalmologic Procedure indication
Mouth Irritation indication
Prevent Minor Bacterial Skin Infection indication
Minor Skin Wound Pain indication
Regional Anesthesia for Ophthalmologic Surgery indication
Local Anesthesia for Endotracheal Intubation indication
Neuropathic pain off-label use 247398009
Inflammatory dermatosis off-label use 703938007
Mycosis contraindication 3218000 DOID:1564
Gastritis contraindication 4556007 DOID:4029
Alcoholism contraindication 7200002
Psoriasis contraindication 9014002 DOID:8893
Bacterial septicemia contraindication 10001005 DOID:0040085
Sinus tachycardia contraindication 11092001
Measles contraindication 14189004 DOID:8622
Lowered convulsive threshold contraindication 19260006
Cirrhosis of liver contraindication 19943007 DOID:5082
Myocardial infarction contraindication 22298006 DOID:5844
Atopic dermatitis contraindication 24079001 DOID:3310
Abscess of intestine contraindication 24557004
Acute tuberculosis contraindication 25629007
Complete atrioventricular block contraindication 27885002
Shock contraindication 27942005
Hypovolemia contraindication 28560003
Parkinsonism contraindication 32798002
Hyperthyroidism contraindication 34486009 DOID:7998
Gastrointestinal fistula contraindication 37831005
Hypertensive disorder contraindication 38341003 DOID:10763
Infectious disease contraindication 40733004
Gastrointestinal ulcer contraindication 40845000
Hypothyroidism contraindication 40930008 DOID:1459
Hypokalemia contraindication 43339004
Body fluid retention contraindication 43498006
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Stokes-Adams syndrome contraindication 46935006
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Atrial fibrillation contraindication 49436004 DOID:0060224
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Sinus bradycardia contraindication 49710005
Vitamin K deficiency contraindication 52675005 DOID:11249
Nasal polyp contraindication 52756005
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Corneal opacity contraindication 64634000
Blood coagulation disorder contraindication 64779008 DOID:1247
Osteoporosis contraindication 64859006 DOID:11476
Cerebral arteriosclerosis contraindication 65312002
Psychotic disorder contraindication 69322001
Diabetes mellitus contraindication 73211009 DOID:9351
Factor II deficiency contraindication 73975000
Wolff-Parkinson-White pattern contraindication 74390002 DOID:384
Gastrointestinal hemorrhage contraindication 74474003
Thrombotic thrombocytopenic purpura contraindication 78129009 DOID:10772
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Open-angle glaucoma contraindication 84494001 DOID:1067
Herpes simplex contraindication 88594005 DOID:8566
Cardiogenic shock contraindication 89138009
Kidney disease contraindication 90708001 DOID:557
Thyrotoxicosis contraindication 90739004 DOID:7997
Hemophilia contraindication 90935002
Corneal ulcer contraindication 91514001 DOID:8463
Disorder of skin contraindication 95320005 DOID:37
Disorder of mucous membrane contraindication 95351003
Anemia due to enzyme deficiency contraindication 111577008
Magnetic resonance imaging contraindication 113091000
Open wound contraindication 125643001
Seizure disorder contraindication 128613002
Bleeding contraindication 131148009
Ophthalmic herpes simplex contraindication 186542001
Angina pectoris contraindication 194828000
Primary dilated cardiomyopathy contraindication 195021004
Partial atrioventricular block contraindication 195039008
Heart block contraindication 233916004
Anastomosis of intestine contraindication 235407009
Gastroesophageal reflux disease contraindication 235595009 DOID:8534
Disease of liver contraindication 235856003 DOID:409
Sepsis syndrome contraindication 238150007
Telangiectasia disorder contraindication 247479008
Diverticulitis of gastrointestinal tract contraindication 271366000
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Varicella-zoster virus infection contraindication 309465005
Deficiency of cholinesterase contraindication 360607009
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Hypoxia contraindication 389086002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Pseudomembranous enterocolitis contraindication 397683000
Atrophoderma contraindication 399979006
Peripheral vascular disease contraindication 400047006
Breastfeeding (mother) contraindication 413712001
Disorder of coronary artery contraindication 414024009
Denuded skin contraindication 418242004
Uncontrolled Epilepsy contraindication
Intracerebral Mass contraindication
Lidocaine Toxicity contraindication
Reduced Hepatic Blood Flow contraindication




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Dogs Urinary tract infections caused by Hemolytic Staphylococcus species Indication
Dogs Urinary tract infections caused by Streptococcus species Indication
Dogs Bacterial pulmonary infections caused by Brucella bronchiseptica Indication
Dogs Bacterial pulmonary infections caused by Streptococcus pyogenes Indication
Dogs Bacterial pulmonary infections caused by Staphylococcus aureus Indication
Dogs Secondary bacterial infections caused by Micrococcus pyogenes var albus Indication
Dogs Secondary bacterial infections caused by Brucella bronchiseptica Indication
Dogs Secondary bacterial infections caused by Streptococcus species Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Liquamycin Intramuscular Zoetis Inc. 2
Aquachel 100 mg Zoetis Inc. 2
Tributame Euthanasia Solution Cronus Pharma Specialities India Private Limited 3

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.4 acidic
pKa2 7.92 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
3.5% AKTEN THEA PHARMA N022221 Oct. 7, 2008 RX GEL OPHTHALMIC 8759401 July 24, 2026 METHOD OF INDUCING TOPICAL ANESTHESIA IN THE EYE
0.5MG ZINGO POWDER PHARMS N022114 Aug. 16, 2007 RX SYSTEM INTRADERMAL 8540665 Oct. 22, 2029 ZINGO INTRADERMAL INJECTION SYSTEM IS A DRUG DELIVERY SYSTEM THAT IS CAPABLE OF DELIVERING FINE DRY POWDERED LIDOCAINE HYDROCHLORIDE MONOHYDRATE FOR LOCAL ANESTHETIC ACTION
1.8% ZTLIDO SCILEX PHARMS INC N207962 Feb. 28, 2018 RX PATCH TOPICAL 9925264 May 10, 2031 METHOD FOR RELIEVING THE PAIN ASSOCIATED WITH POST-HERPETIC NEURALGIA
0.5MG ZINGO POWDER PHARMS N022114 Aug. 16, 2007 RX SYSTEM INTRADERMAL 9358338 April 27, 2035 ZINGO IS A POWDER INTRADERMAL SYSTEM THAT IS CAPABLE OF DELIVERING FINE DRY POWDERED LIDOCAINE HYDROCHLORIDE MONOHYDRATE FOR LOCAL ANESTHETIC ACTION
0.5MG ZINGO POWDER PHARMS N022114 Aug. 16, 2007 RX SYSTEM INTRADERMAL 9370622 Sept. 28, 2035 ZINGO IS A POWDER INTRADERMAL SYSTEM THAT IS CAPABLE OF DELIVERING FINE DRY POWDERED LIDOCAINE HYDROCHLORIDE MONOHYDRATE FOR LOCAL ANESTHETIC ACTION

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 Kd 4.80 IUPHAR CHEMBL
Sodium channel protein type 2 subunit alpha Ion channel BLOCKER UNKNOWN CHEMBL
Sodium channel protein type 3 subunit alpha Ion channel BLOCKER IC50 4.98 CHEMBL CHEMBL
Sodium channel protein type 4 subunit alpha Ion channel BLOCKER IC50 5.70 CHEMBL CHEMBL
Sodium channel protein type 9 subunit alpha Ion channel BLOCKER IC50 4.54 CHEMBL CHEMBL
Sodium channel protein type 10 subunit alpha Ion channel BLOCKER UNKNOWN CHEMBL
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 4 Ion channel IC50 3.56 WOMBAT-PK
Acetylcholine receptor Ion channel IC50 4.96 WOMBAT-PK
5-hydroxytryptamine receptor 3A Ion channel IC50 3.30 WOMBAT-PK
Sodium channel protein type 5 subunit alpha Ion channel BLOCKER IC50 4.20 IUPHAR
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel IC50 4.25 CHEMBL
Sodium channel protein type X alpha subunit Ion channel BLOCKER IC50 4 IUPHAR

External reference:

IDSource
4018262 VUID
N0000146592 NUI
D00358 KEGG_DRUG
6108-05-0 SECONDARY_CAS_RN
73-78-9 SECONDARY_CAS_RN
4017992 VANDF
4018262 VANDF
C0023660 UMLSCUI
CHEBI:6456 CHEBI
LQZ PDB_CHEM_ID
CHEMBL79 ChEMBL_ID
DB00281 DRUGBANK_ID
CHEMBL1200409 ChEMBL_ID
CHEMBL541521 ChEMBL_ID
D008012 MESH_DESCRIPTOR_UI
3676 PUBCHEM_CID
4202 INN_ID
2623 IUPHAR_LIGAND_ID
98PI200987 UNII
1299236 RXNORM
14031 MMSL
4977 MMSL
4978 MMSL
73102 MMSL
9242 MMSL
d00059 MMSL
000626 NDDF
000627 NDDF
001350 NDDF
001351 NDDF
387480006 SNOMEDCT_US
61773008 SNOMEDCT_US
82573000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Lidocaine Viscous HUMAN PRESCRIPTION DRUG LABEL 1 0054-0548 SOLUTION 20 mg ORAL ANDA 20 sections
Lidocaine Viscous HUMAN PRESCRIPTION DRUG LABEL 1 0054-3500 SOLUTION 20 mg ORAL ANDA 20 sections
Lidocaine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-3505 SOLUTION 40 mg TOPICAL ANDA 18 sections
basic care endure HUMAN OTC DRUG LABEL 1 0113-7200 SPRAY 10 mg TOPICAL OTC monograph final 16 sections
basic care lidocaine HUMAN OTC DRUG LABEL 1 0113-7219 PATCH 560 mg TOPICAL OTC monograph not final 14 sections
basic care lidocaine HUMAN OTC DRUG LABEL 1 0113-7700 PATCH 560 mg TOPICAL OTC monograph not final 14 sections
Good Sense endure HUMAN OTC DRUG LABEL 1 0113-8000 SPRAY 10 mg TOPICAL OTC monograph final 16 sections
Lidocaine and Prilocaine HUMAN PRESCRIPTION DRUG LABEL 2 0115-1468 CREAM 25 mg TOPICAL ANDA 20 sections
Lidocaine Viscous HUMAN PRESCRIPTION DRUG LABEL 1 0121-0903 SOLUTION 20 mg ORAL ANDA 20 sections
Lidocaine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9575 INJECTION, SOLUTION 20 mg INFILTRATION ANDA 12 sections
Lidocaine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9576 INJECTION, SOLUTION 20 mg INFILTRATION ANDA 12 sections
Lidocaine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9577 INJECTION, SOLUTION 10 mg INFILTRATION ANDA 12 sections
Lidocaine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9578 INJECTION, SOLUTION 10 mg INFILTRATION ANDA 12 sections
Lidocaine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9579 INJECTION, SOLUTION 10 mg INFILTRATION ANDA 12 sections
Lidocaine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9594 INJECTION, SOLUTION 20 mg EPIDURAL ANDA 12 sections
Lidocaine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9595 INJECTION, SOLUTION 10 mg EPIDURAL ANDA 12 sections
Lidocaine HUMAN PRESCRIPTION DRUG LABEL 1 0168-0204 OINTMENT 50 mg TOPICAL ANDA 21 sections
Lidocaine and Prilocaine HUMAN PRESCRIPTION DRUG LABEL 2 0168-0357 CREAM 25 mg TOPICAL ANDA 25 sections
LIDOCAINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0264-9376 INJECTION 10 mg INFILTRATION ANDA 12 sections
LIDOCAINE HCl and EPINEPHRINE HUMAN PRESCRIPTION DRUG LABEL 2 0264-9378 INJECTION 15 mg EPIDURAL ANDA 12 sections
Lidocaine Hydrochloride and Dextrose HUMAN PRESCRIPTION DRUG LABEL 2 0264-9594 INJECTION, SOLUTION 0.40 g INTRAVENOUS NDA 23 sections
Lidocaine Hydrochloride and Dextrose HUMAN PRESCRIPTION DRUG LABEL 2 0264-9598 INJECTION, SOLUTION 0.80 g INTRAVENOUS NDA 23 sections
Lidocaine Hydrochloride and Dextrose HUMAN PRESCRIPTION DRUG LABEL 1 0338-0409 INJECTION, SOLUTION 4 mg INTRAVENOUS NDA 24 sections
Lidocaine Hydrochloride and Dextrose HUMAN PRESCRIPTION DRUG LABEL 1 0338-0411 INJECTION, SOLUTION 8 mg INTRAVENOUS NDA 24 sections
Lidocaine HUMAN PRESCRIPTION DRUG LABEL 1 0362-0221 OINTMENT 5 g TOPICAL ANDA 22 sections
Lidocaine HUMAN PRESCRIPTION DRUG LABEL 2 0362-0262 INJECTION, SOLUTION 20 mg SUBCUTANEOUS ANDA 23 sections
Lidocaine HUMAN PRESCRIPTION DRUG LABEL 2 0362-0898 INJECTION, SOLUTION 20 mg SUBCUTANEOUS ANDA 23 sections
Lignospan Standard HUMAN PRESCRIPTION DRUG LABEL 2 0362-1095 INJECTION, SOLUTION 20 mg SUBCUTANEOUS ANDA 23 sections
Lignospan Forte HUMAN PRESCRIPTION DRUG LABEL 2 0362-1096 INJECTION, SOLUTION 20 mg SUBCUTANEOUS ANDA 23 sections
Octocaine 50 HUMAN PRESCRIPTION DRUG LABEL 2 0362-9010 INJECTION, SOLUTION 20 mg SUBCUTANEOUS ANDA 24 sections