lidocaine 🐶 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 µM/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 1104.60 9.47 377 101462 4342 63382841
Local anaesthetic systemic toxicity 566.88 9.47 154 101685 745 63386438
Product quality issue 457.27 9.47 412 101427 35453 63351730
Sinusitis 370.27 9.47 993 100846 225660 63161523
Infusion site pain 295.92 9.47 233 101606 16636 63370547
Infusion site swelling 285.02 9.47 184 101655 9586 63377597
Pemphigus 258.26 9.47 8 101831 183718 63203465
Toxic anterior segment syndrome 255.44 9.47 99 101740 1672 63385511
Contraindicated product administered 241.14 9.47 32 101807 217616 63169567
Infusion site extravasation 231.83 9.47 166 101673 10260 63376923
Hand deformity 231.41 9.47 5 101834 159452 63227731
Infusion site erythema 230.43 9.47 173 101666 11506 63375677
Drug intolerance 217.37 9.47 112 101727 308549 63078634
Anaesthetic complication 211.72 9.47 89 101750 1871 63385312
Glossodynia 206.22 9.47 23 101816 178853 63208330
Synovitis 205.80 9.47 28 101811 186890 63200293
Infusion site pruritus 199.42 9.47 123 101716 5912 63381271
Anaphylactic reaction 196.30 9.47 368 101471 65732 63321451
Systemic lupus erythematosus 196.20 9.47 47 101792 208871 63178312
Anaphylactic shock 192.72 9.47 213 101626 23420 63363763
COVID-19 186.78 9.47 498 101341 112605 63274578
Joint swelling 185.70 9.47 152 101687 327514 63059669
Infusion site haemorrhage 181.77 9.47 109 101730 4977 63382206
Anti-cyclic citrullinated peptide antibody positive 171.19 9.47 3 101836 116209 63270974
Cardiac arrest 153.28 9.47 408 101431 92137 63295046
Alopecia 149.94 9.47 193 101646 337343 63049840
Arthropathy 147.07 9.47 98 101741 234694 63152489
Hepatic enzyme increased 145.96 9.47 71 101768 202257 63184926
Completed suicide 140.25 9.47 31 101808 145642 63241541
Kounis syndrome 139.64 9.47 64 101775 1666 63385517
Pericarditis 139.49 9.47 22 101817 131557 63255626
Lagophthalmos 137.50 9.47 42 101797 328 63386855
Seasonal allergy 136.06 9.47 168 101671 20782 63366401
Drug ineffective for unapproved indication 131.56 9.47 213 101626 33850 63353333
Maternal exposure during delivery 129.00 9.47 58 101781 1442 63385741
Infusion site bruising 126.35 9.47 78 101761 3754 63383429
Wound 124.42 9.47 53 101786 163210 63223973
Rheumatoid factor positive 121.05 9.47 3 101836 84403 63302780
Treatment failure 118.13 9.47 88 101751 198955 63188228
Insurance issue 114.84 9.47 88 101751 6033 63381150
Illness 114.36 9.47 247 101592 48812 63338371
Methaemoglobinaemia 114.10 9.47 62 101777 2341 63384842
Ear infection 111.23 9.47 211 101628 38002 63349181
Urinary tract infection 108.22 9.47 761 101078 263923 63123260
Abdominal discomfort 107.29 9.47 221 101618 320664 63066519
Incorrect drug administration rate 104.32 9.47 70 101769 3892 63383291
Bronchitis 103.59 9.47 436 101403 124499 63262684
Upper respiratory tract infection 102.41 9.47 327 101512 81720 63305463
Therapeutic product effect decreased 100.44 9.47 97 101742 193090 63194093
Stress cardiomyopathy 94.55 9.47 95 101744 9355 63377828
Therapy interrupted 91.74 9.47 177 101662 32278 63354905
General physical health deterioration 90.53 9.47 114 101725 201288 63185895
Rheumatoid arthritis 89.82 9.47 169 101670 253650 63133533
Corneal oedema 89.40 9.47 45 101794 1448 63385735
Folliculitis 86.39 9.47 7 101832 70310 63316873
Bradycardia 84.34 9.47 284 101555 72943 63314240
Respiratory tract infection 83.45 9.47 197 101642 41286 63345897
Generalised tonic-clonic seizure 80.50 9.47 157 101682 28859 63358324
Pulseless electrical activity 79.67 9.47 78 101761 7443 63379740
Body tinea 79.54 9.47 45 101794 1840 63385343
Drug ineffective 78.23 9.47 1194 100645 1043571 62343612
Helicobacter infection 77.54 9.47 26 101813 92759 63294424
Systemic toxicity 73.86 9.47 19 101820 71 63387112
Anaesthetic complication neurological 73.32 9.47 24 101815 240 63386943
Infusion site mass 73.07 9.47 44 101795 2024 63385159
Infusion site nodule 72.25 9.47 39 101800 1453 63385730
Muscle injury 71.36 9.47 10 101829 65335 63321848
Dermatitis contact 71.03 9.47 88 101751 10920 63376263
Sleep disorder due to general medical condition, insomnia type 70.80 9.47 3 101836 52214 63334969
Product dose omission issue 64.97 9.47 617 101222 233696 63153487
Infusion site rash 64.25 9.47 40 101799 1954 63385229
Seizure 63.57 9.47 397 101442 132237 63254946
Multiple allergies 62.64 9.47 93 101746 13709 63373474
Infusion site urticaria 61.73 9.47 36 101803 1560 63385623
Extradural abscess 61.32 9.47 30 101809 907 63386276
Pulse absent 61.20 9.47 58 101781 5316 63381867
Psoriatic arthropathy 60.26 9.47 36 101803 91484 63295699
Inhibitory drug interaction 60.22 9.47 44 101795 2805 63384378
Type I hypersensitivity 58.96 9.47 44 101795 2898 63384285
Arthralgia 57.33 9.47 611 101228 569099 62818084
Rheumatic fever 56.76 9.47 3 101836 43108 63344075
Swelling 56.13 9.47 239 101600 275139 63112044
Liver injury 56 9.47 14 101825 60506 63326677
Administration site swelling 54.61 9.47 31 101808 1276 63385907
Discomfort 54.41 9.47 117 101722 167257 63219926
Product use issue 54.33 9.47 177 101662 220343 63166840
Infection susceptibility increased 54.05 9.47 45 101794 3476 63383707
Staphylococcal infection 53.81 9.47 167 101672 41089 63346094
Procedural hypotension 51.82 9.47 29 101810 1161 63386022
Embolia cutis medicamentosa 51.57 9.47 21 101818 406 63386777
Impaired healing 51.52 9.47 53 101786 102489 63284694
Musculoskeletal stiffness 50.62 9.47 141 101698 184477 63202706
Administration site pain 48.98 9.47 25 101814 829 63386354
Unresponsive to stimuli 48.94 9.47 142 101697 33674 63353509
Apnoea 48.37 9.47 62 101777 7960 63379223
Post procedural complication 48.10 9.47 93 101746 16981 63370202
Kidney infection 46.53 9.47 110 101729 23066 63364117
Headache 45.29 9.47 1332 100507 631909 62755274
Cauda equina syndrome 45.22 9.47 25 101814 977 63386206
Ventricular tachycardia 44.73 9.47 99 101740 19880 63367303
Purtscher retinopathy 44.56 9.47 13 101826 85 63387098
Pneumocephalus 44.55 9.47 15 101824 165 63387018
C-reactive protein abnormal 43.95 9.47 10 101829 46086 63341097
Glucose tolerance impaired 43.11 9.47 53 101786 6524 63380659
Hypotension 42.81 9.47 644 101195 271960 63115223
Rash 42.04 9.47 640 101199 560231 62826952
Extradural haematoma 41.95 9.47 29 101810 1693 63385490
Acute motor-sensory axonal neuropathy 41.13 9.47 16 101823 273 63386910
Bronchospasm 40.25 9.47 87 101752 17193 63369990
Cellulitis 39.67 9.47 246 101593 81712 63305471
Inappropriate schedule of product administration 39.54 9.47 294 101545 103671 63283512
Ophthalmoplegia 38.87 9.47 26 101813 1438 63385745
Infusion site irritation 38.70 9.47 22 101817 908 63386275
COVID-19 immunisation 38.69 9.47 28 101811 1759 63385424
Hypopyon 37.88 9.47 20 101819 712 63386471
Blood pressure decreased 37.88 9.47 205 101634 64817 63322366
Endophthalmitis 37.58 9.47 37 101802 3555 63383628
Nystagmus 37.39 9.47 48 101791 6172 63381011
Vitritis 37.38 9.47 22 101817 970 63386213
Infusion site discomfort 36.76 9.47 25 101814 1421 63385762
Application site rash 36.44 9.47 31 101808 2467 63384716
Ventricular fibrillation 36.36 9.47 67 101772 11800 63375383
Lower respiratory tract infection 36.29 9.47 101 101738 132206 63254977
Poor quality sleep 36.17 9.47 91 101748 19844 63367339
Surgery 35.92 9.47 133 101706 35779 63351404
Platelet aggregation inhibition 35.80 9.47 12 101827 130 63387053
Infusion site reaction 35.77 9.47 36 101803 3551 63383632
Mobility decreased 35.11 9.47 90 101749 121069 63266114
Blister 34.94 9.47 100 101739 129714 63257469
Abortion spontaneous 34.85 9.47 16 101823 47179 63340004
Incorrect route of product administration 34.76 9.47 110 101729 27342 63359841
Diplopia 34.68 9.47 100 101739 23628 63363555
Mental status changes 34.19 9.47 140 101699 39459 63347724
Sensory loss 34.17 9.47 60 101779 10178 63377005
Hypersensitivity 33.94 9.47 303 101536 292382 63094801
Infusion site warmth 33.80 9.47 26 101813 1792 63385391
Septic arthritis staphylococcal 33.54 9.47 16 101823 457 63386726
Acute kidney injury 33.09 9.47 267 101572 263148 63124035
Eyelid ptosis 33.03 9.47 49 101790 7218 63379965
Procedural complication 32.74 9.47 42 101797 5397 63381786
Tooth infection 32.72 9.47 82 101757 17838 63369345
Retinal vasculitis 32.56 9.47 20 101819 954 63386229
Suicide attempt 32.31 9.47 30 101809 60888 63326295
Peripheral swelling 32.30 9.47 272 101567 265670 63121513
Diarrhoea 32.17 9.47 888 100951 714478 62672705
Neutropenia 31.98 9.47 158 101681 174847 63212336
Paralysis 31.73 9.47 57 101782 9843 63377340
Anterior chamber cell 31.42 9.47 16 101823 528 63386655
Spinal operation 30.95 9.47 51 101788 8220 63378963
Paraplegia 30.74 9.47 29 101810 2643 63384540
Gastroenteritis viral 30.04 9.47 95 101744 23605 63363578
Arthritis bacterial 29.98 9.47 44 101795 6419 63380764
Viral infection 29.94 9.47 125 101714 35538 63351645
Nerve root injury 29.92 9.47 8 101831 36 63387147
Aqueous fibrin 29.72 9.47 9 101830 68 63387115
Fear 29.69 9.47 73 101766 15693 63371490
Pneumonia 29.42 9.47 949 100890 455818 62931365
Condition aggravated 29.39 9.47 461 101378 401756 62985427
Ill-defined disorder 29.26 9.47 54 101785 81701 63305482
Unevaluable event 29.25 9.47 161 101678 51225 63335958
Bursitis infective 28.98 9.47 21 101818 1322 63385861
C-reactive protein increased 28.49 9.47 69 101770 94638 63292545
Cystitis 28.48 9.47 168 101671 54823 63332360
Phrenic nerve paralysis 28.42 9.47 11 101828 185 63386998
Corneal epithelium defect 28.34 9.47 13 101826 339 63386844
Hepatotoxicity 28.23 9.47 12 101827 37029 63350154
Peripheral nerve injury 28.20 9.47 14 101825 437 63386746
Type 2 diabetes mellitus 27.79 9.47 37 101802 63831 63323352
Anhedonia 27.59 9.47 57 101782 10917 63376266
Retinal artery occlusion 27.20 9.47 22 101817 1631 63385552
Status epilepticus 27.07 9.47 69 101770 15164 63372019
Fear of eating 27.01 9.47 13 101826 379 63386804
Chills 26.78 9.47 289 101550 113089 63274094
Tracheal deviation 26.76 9.47 10 101829 152 63387031
Skin infection 26.71 9.47 68 101771 14934 63372249
Foetal exposure during delivery 26.64 9.47 10 101829 154 63387029
Meningitis chemical 26.64 9.47 10 101829 154 63387029
Spinal epidural haemorrhage 26.57 9.47 9 101830 101 63387082
Migraine 26.56 9.47 268 101571 103078 63284105
Mydriasis 26.49 9.47 59 101780 11897 63375286
Therapeutic product effect incomplete 26.39 9.47 107 101732 124949 63262234
Administration site erythema 26.32 9.47 16 101823 749 63386434
Parophthalmia 26.23 9.47 12 101827 311 63386872
Loss of personal independence in daily activities 26.13 9.47 75 101764 97215 63289968
Application site irritation 26.11 9.47 22 101817 1728 63385455
Nerve block 25.99 9.47 16 101823 766 63386417
Eye infection 25.87 9.47 59 101780 12086 63375097
Anaphylactoid shock 25.74 9.47 12 101827 325 63386858
Intentional self-injury 25.66 9.47 5 101834 25682 63361501
Irritable bowel syndrome 25.62 9.47 59 101780 82353 63304830
Blood cholesterol increased 25.62 9.47 72 101767 93960 63293223
Tachycardia 25.55 9.47 296 101543 117860 63269323
Quadriparesis 25.23 9.47 23 101816 2006 63385177
Back pain 25.00 9.47 577 101262 263568 63123615
Upper airway obstruction 24.95 9.47 15 101824 688 63386495
Renal injury 24.88 9.47 50 101789 9389 63377794
Spinal anaesthesia 24.65 9.47 7 101832 41 63387142
Removal of foreign body 24.65 9.47 7 101832 41 63387142
Anaphylactoid reaction 24.40 9.47 30 101809 3693 63383490
Sinus tachycardia 24.37 9.47 90 101749 24178 63363005
Neonatal toxicity 24.33 9.47 6 101833 18 63387165
Liver function test abnormal 24.08 9.47 25 101814 48156 63339027
Intentional overdose 23.94 9.47 52 101787 74100 63313083
Drug resistance 23.92 9.47 4 101835 22929 63364254
Lactic acidosis 23.90 9.47 16 101823 38271 63348912
Product contamination microbial 23.84 9.47 10 101829 209 63386974
Anal skin tags 23.47 9.47 13 101826 510 63386673
Device infusion issue 23.22 9.47 22 101817 2016 63385167
Sopor 22.82 9.47 4 101835 22160 63365023
Purpura 22.81 9.47 54 101785 11331 63375852
Visual acuity reduced 22.81 9.47 82 101757 21744 63365439
Emotional distress 22.73 9.47 108 101731 32441 63354742
Application site erythema 22.55 9.47 33 101806 4802 63382381
Hip arthroplasty 22.41 9.47 26 101813 47620 63339563
Inability to afford medication 22.39 9.47 23 101816 2324 63384859
Neurotoxicity 22.36 9.47 69 101770 16921 63370262
Infusion site discolouration 22.22 9.47 15 101824 842 63386341
Hypoaesthesia oral 22.10 9.47 58 101781 12975 63374208
Prescribed underdose 22.02 9.47 10 101829 29679 63357504
Bundle branch block left 21.81 9.47 40 101799 7019 63380164
Loss of consciousness 21.28 9.47 286 101553 117835 63269348
Immunisation reaction 21.22 9.47 13 101826 617 63386566
Disease progression 21.19 9.47 113 101726 122645 63264538
Pneumonia mycoplasmal 21.19 9.47 15 101824 910 63386273
Spinal epidural haematoma 20.70 9.47 16 101823 1111 63386072
Cyanosis 20.66 9.47 67 101772 16868 63370315
Myopathy toxic 20.62 9.47 12 101827 518 63386665
Administration site extravasation 20.62 9.47 15 101824 950 63386233
Axillary nerve injury 20.53 9.47 5 101834 14 63387169
Neuromuscular block prolonged 20.37 9.47 12 101827 530 63386653
Atonic urinary bladder 20.31 9.47 7 101832 83 63387100
Bacterial infection 20.16 9.47 73 101766 19426 63367757
Environmental exposure 20.09 9.47 7 101832 86 63387097
Sinus disorder 19.78 9.47 85 101754 24468 63362715
Vitamin D increased 19.76 9.47 13 101826 699 63386484
Hospitalisation 19.68 9.47 216 101623 84865 63302318
Abdominal pain upper 19.64 9.47 224 101615 206220 63180963
Stomatitis 19.60 9.47 136 101703 138589 63248594
Arachnoiditis 19.58 9.47 10 101829 332 63386851
Infusion site induration 19.55 9.47 16 101823 1206 63385977
Trigemino-cardiac reflex 19.41 9.47 6 101833 49 63387134
Trigeminal palsy 19.37 9.47 5 101834 19 63387164
Oral herpes 19.30 9.47 88 101751 25986 63361197
Respiratory depression 19.27 9.47 57 101782 13658 63373525
Thrombocytopenia 19.06 9.47 153 101686 151004 63236179
Product contamination 18.99 9.47 13 101826 747 63386436
Confusional state 18.94 9.47 266 101573 236114 63151069
Punctate keratitis 18.86 9.47 12 101827 609 63386574
Device expulsion 18.75 9.47 17 101822 34905 63352278
Drug reaction with eosinophilia and systemic symptoms 18.74 9.47 16 101823 33820 63353363
Pharyngitis streptococcal 18.61 9.47 48 101791 10624 63376559
Red blood cell sedimentation rate increased 18.61 9.47 26 101813 43956 63343227
Tryptase increased 18.51 9.47 10 101829 373 63386810
Toxicity to various agents 18.37 9.47 523 101316 246727 63140456
Impaired quality of life 18.16 9.47 56 101783 13727 63373456
Application site discomfort 18.15 9.47 10 101829 388 63386795
Blood creatinine increased 18.01 9.47 76 101763 87768 63299415
Bone density decreased 18.00 9.47 58 101781 14554 63372629
Airway peak pressure increased 17.98 9.47 9 101830 286 63386897
Ventricular hypokinesia 17.87 9.47 29 101810 4615 63382568
Maternal exposure during pregnancy 17.85 9.47 247 101592 219815 63167368
Circulatory collapse 17.72 9.47 76 101763 21862 63365321
Conjunctival oedema 17.52 9.47 12 101827 690 63386493
Brain stem syndrome 17.43 9.47 10 101829 420 63386763
Hepatitis 17.36 9.47 23 101816 39765 63347418
Application site vesicles 17.33 9.47 16 101823 1419 63385764
Shock 17.22 9.47 79 101760 23384 63363799
Normal newborn 17.19 9.47 40 101799 8301 63378882
Skin disorder 17.16 9.47 93 101746 29414 63357769
Glossoptosis 17.05 9.47 6 101833 76 63387107
Adverse event 16.77 9.47 54 101785 67505 63319678
Propionibacterium infection 16.72 9.47 5 101834 36 63387147
Spinal cord oedema 16.70 9.47 7 101832 146 63387037
Nephrolithiasis 16.68 9.47 120 101719 41864 63345319
Nerve injury 16.60 9.47 44 101795 9902 63377281
Stridor 16.43 9.47 24 101815 3486 63383697
Cutis laxa 16.32 9.47 7 101832 155 63387028
Aspiration joint abnormal 16.31 9.47 3 101836 0 63387183
Eye infarction 16.26 9.47 5 101834 40 63387143
Administration site reaction 16.20 9.47 8 101831 247 63386936
Hyponatraemia 16.15 9.47 109 101730 111791 63275392
Cataract 16.15 9.47 151 101688 56902 63330281
Spinal cord compression 16.09 9.47 26 101813 4122 63383061
Influenza like illness 16.08 9.47 171 101668 66653 63320530
Spinal cord infarction 15.93 9.47 8 101831 256 63386927
Knee arthroplasty 15.90 9.47 40 101799 54166 63333017
Haemorrhoids 15.83 9.47 74 101765 22076 63365107
Hemiplegic migraine 15.78 9.47 6 101833 96 63387087
Leukopenia 15.76 9.47 67 101772 77223 63309960
Piloerection 15.73 9.47 9 101830 376 63386807
No adverse event 15.68 9.47 117 101722 41288 63345895
Streptococcal infection 15.67 9.47 31 101808 5756 63381427
Infusion site scar 15.60 9.47 10 101829 514 63386669
Psoriasis 15.59 9.47 79 101760 86878 63300305
Paranasal cyst 15.27 9.47 9 101830 398 63386785
Nail bed tenderness 15.23 9.47 9 101830 400 63386783
Injection site discharge 15.17 9.47 12 101827 862 63386321
Retinal haemorrhage 15.15 9.47 28 101811 4941 63382242
Gastrointestinal bacterial overgrowth 15.07 9.47 12 101827 870 63386313
Inadequate analgesia 15.07 9.47 21 101818 2922 63384261
Vasoplegia syndrome 15.05 9.47 16 101823 1683 63385500
Product availability issue 14.87 9.47 25 101814 4096 63383087
Localised infection 14.81 9.47 91 101748 30119 63357064
Hallucination, tactile 14.75 9.47 8 101831 301 63386882
Laryngeal oedema 14.73 9.47 30 101809 5688 63381495
Dysarthria 14.68 9.47 118 101721 42593 63344590
Incision site rash 14.61 9.47 4 101835 20 63387163
Gastric mucosa erythema 14.58 9.47 8 101831 308 63386875
Corneal abrasion 14.49 9.47 13 101826 1111 63386072
Drug tolerance decreased 14.41 9.47 5 101834 17468 63369715
Electrocardiogram ST segment elevation 14.40 9.47 24 101815 3903 63383280
Arthritis infective 14.39 9.47 32 101807 6446 63380737
Nerve root injury cervical 14.24 9.47 3 101836 3 63387180
Cranial nerve palsies multiple 14.15 9.47 4 101835 23 63387160
Autonomic neuropathy 14.14 9.47 13 101826 1146 63386037
Sleep disorder 14.12 9.47 75 101764 81491 63305692
Inflammation 14.05 9.47 76 101763 82197 63304986
Ventricular extrasystoles 14.04 9.47 46 101793 11641 63375542
Liquid product physical issue 13.92 9.47 13 101826 1169 63386014
Foetal heart rate abnormal 13.83 9.47 10 101829 627 63386556
Neck pain 13.81 9.47 171 101668 69147 63318036
Tooth abscess 13.78 9.47 54 101785 14915 63372268
Product distribution issue 13.73 9.47 14 101825 1402 63385781
Hyperlipidaemia 13.71 9.47 65 101774 19506 63367677
Anxiety 13.70 9.47 451 101388 217090 63170093
Vascular stenosis 13.61 9.47 8 101831 352 63386831
Implant site bruising 13.55 9.47 8 101831 355 63386828
Transferrin decreased 13.53 9.47 7 101832 239 63386944
Hyperthermia malignant 13.51 9.47 11 101828 823 63386360
Disease recurrence 13.50 9.47 15 101824 28015 63359168
Anal sphincter atony 13.42 9.47 7 101832 243 63386940
Poor venous access 13.34 9.47 53 101786 14732 63372451
Post procedural infection 13.29 9.47 39 101800 9303 63377880
Fungal infection 13.29 9.47 103 101736 36771 63350412
Incontinence 13.28 9.47 45 101794 11587 63375596
Meningitis 13.27 9.47 33 101806 7144 63380039
Liver disorder 13.26 9.47 43 101796 53644 63333539
Musculoskeletal pain 13.26 9.47 90 101749 92187 63294996
Accidental overdose 13.24 9.47 73 101766 23236 63363947
Myelitis transverse 13.22 9.47 13 101826 1247 63385936
Vascular malformation 13.21 9.47 8 101831 372 63386811
Impaired work ability 12.95 9.47 59 101780 17416 63369767
Immunoglobulins decreased 12.94 9.47 13 101826 1279 63385904
Abdominal pain 12.93 9.47 365 101474 293091 63094092
Macular degeneration 12.93 9.47 12 101827 24364 63362819
Intentional dose omission 12.75 9.47 35 101804 8040 63379143
Spinal stroke 12.69 9.47 4 101835 35 63387148
Therapy cessation 12.65 9.47 88 101751 30369 63356814
Pupillary reflex impaired 12.62 9.47 16 101823 2031 63385152
Diplegia 12.61 9.47 12 101827 1105 63386078
Skin test positive 12.60 9.47 10 101829 722 63386461
Oesophageal adenocarcinoma recurrent 12.60 9.47 4 101835 36 63387147
Sinus operation 12.57 9.47 18 101821 2568 63384615
Cataract nuclear 12.52 9.47 11 101828 914 63386269
Gastrointestinal infection 12.50 9.47 38 101801 9243 63377940
Left ventricle outflow tract obstruction 12.31 9.47 7 101832 289 63386894
Apnoeic attack 12.29 9.47 7 101832 290 63386893
Heliotrope rash 12.28 9.47 6 101833 181 63387002
Vascular resistance systemic decreased 12.26 9.47 5 101834 97 63387086
Off label use 12.25 9.47 924 100915 673538 62713645
Uterine hypertonus 12.22 9.47 7 101832 293 63386890
Administration site irritation 12.22 9.47 4 101835 40 63387143
Application site alopecia 12.17 9.47 3 101836 9 63387174
Wrong product administered 12.17 9.47 29 101810 6112 63381071
Procedural anxiety 12.08 9.47 10 101829 766 63386417
Application site pain 12.05 9.47 23 101816 4159 63383024
Pulmonary fibrosis 11.97 9.47 29 101810 39780 63347403
Vaginal abscess 11.89 9.47 8 101831 447 63386736
Harlequin syndrome 11.88 9.47 4 101835 44 63387139
Foreign body in respiratory tract 11.84 9.47 7 101832 311 63386872
Asthenia 11.83 9.47 499 101340 383105 63004078
Otitis media 11.82 9.47 25 101814 4866 63382317
Haematochezia 11.81 9.47 45 101794 53499 63333684
Intercepted medication error 11.79 9.47 9 101830 613 63386570
Blood pressure systolic increased 11.68 9.47 38 101801 47359 63339824
Cholestasis of pregnancy 11.68 9.47 12 101827 1213 63385970
Electrocardiogram QRS complex shortened 11.67 9.47 8 101831 461 63386722
Decreased appetite 11.64 9.47 310 101529 250742 63136441
Retinal detachment 11.62 9.47 28 101811 5941 63381242
Application site pruritus 11.59 9.47 22 101817 3962 63383221
Intraocular pressure fluctuation 11.57 9.47 4 101835 48 63387135
Administration site scar 11.57 9.47 4 101835 48 63387135
Orbital infection 11.57 9.47 4 101835 48 63387135
Pancreatitis acute 11.55 9.47 16 101823 27150 63360033
Foetal exposure during pregnancy 11.53 9.47 21 101818 31941 63355242
Epidural analgesia 11.49 9.47 4 101835 49 63387134
Airway complication of anaesthesia 11.46 9.47 6 101833 210 63386973
Malabsorption from administration site 11.40 9.47 5 101834 117 63387066
Body dysmorphic disorder 11.34 9.47 7 101832 337 63386846
Scar 11.33 9.47 48 101791 13734 63373449
Obstruction 11.32 9.47 19 101820 3108 63384075
Infusion site injury 11.28 9.47 4 101835 52 63387131
Hypoxia 11.27 9.47 146 101693 59646 63327537
Irregular breathing 11.26 9.47 7 101832 341 63386842
Metapneumovirus infection 11.24 9.47 11 101828 1049 63386134
Lyme disease 11.24 9.47 20 101819 3429 63383754
Epidural haemorrhage 11.21 9.47 5 101834 122 63387061
Orthostatic hypotension 11.15 9.47 26 101813 36134 63351049
Poikiloderma 11.13 9.47 6 101833 223 63386960
Incision site swelling 11.08 9.47 6 101833 225 63386958
Implant site swelling 11.06 9.47 8 101831 502 63386681
Sensitive skin 11.02 9.47 14 101825 1782 63385401
Monoplegia 11.00 9.47 19 101820 3182 63384001
Quadriplegia 10.99 9.47 14 101825 1786 63385397
Arthritis fungal 10.96 9.47 3 101836 15 63387168
Nail bed infection bacterial 10.96 9.47 3 101836 15 63387168
Coccygectomy 10.96 9.47 3 101836 15 63387168
Injection site ischaemia 10.96 9.47 3 101836 15 63387168
Allergy to immunoglobulin therapy 10.94 9.47 4 101835 57 63387126
Incorrect product administration duration 10.91 9.47 42 101797 11504 63375679
Needle issue 10.86 9.47 39 101800 10337 63376846
Infusion site streaking 10.85 9.47 8 101831 517 63386666
Fear-related avoidance of activities 10.84 9.47 5 101834 132 63387051
Blood pressure fluctuation 10.82 9.47 38 101801 46279 63340904
Cystoid macular oedema 10.82 9.47 13 101826 1562 63385621
Liver operation 10.80 9.47 3 101836 16 63387167
Neuroleptic malignant syndrome 10.75 9.47 3 101836 12053 63375130
Jaundice 10.75 9.47 19 101820 29232 63357951
Immunodeficiency 10.71 9.47 10 101829 20244 63366939
Akinesia 10.70 9.47 13 101826 1580 63385603
Accelerated idioventricular rhythm 10.69 9.47 4 101835 61 63387122
Infusion site vesicles 10.64 9.47 8 101831 533 63386650
Procedural pain 10.59 9.47 65 101774 21504 63365679
Premature delivery 10.59 9.47 84 101755 30197 63356986
Respiratory arrest 10.58 9.47 89 101750 32556 63354627
Tenderness 10.44 9.47 67 101772 22511 63364672
Retinal scar 10.41 9.47 5 101834 145 63387038
Food poisoning 10.36 9.47 22 101817 4294 63382889
Bone erosion 10.28 9.47 8 101831 17709 63369474
Erythema 10.21 9.47 361 101478 175390 63211793
Blood methaemoglobin present 10.19 9.47 4 101835 70 63387113
Retinal cyst 10.19 9.47 4 101835 70 63387113
Pleurisy 10.18 9.47 33 101806 8307 63378876
Syringomyelia 10.16 9.47 5 101834 153 63387030
Injection site oedema 10.14 9.47 12 101827 1420 63385763
Delayed recovery from anaesthesia 10.10 9.47 9 101830 762 63386421
Psychotic disorder 10.10 9.47 16 101823 25696 63361487
Bacterial vaginosis 10.07 9.47 12 101827 1430 63385753
Granulomatous liver disease 10.03 9.47 9 101830 769 63386414
Joint stiffness 10.02 9.47 34 101805 41835 63345348
Chemical burn 9.99 9.47 7 101832 418 63386765
Blepharoplasty 9.99 9.47 3 101836 22 63387161
Ophthalmological examination abnormal 9.98 9.47 4 101835 74 63387109
Administration site bruise 9.97 9.47 7 101832 419 63386764
Underdose 9.94 9.47 18 101821 27438 63359745
Anorgasmia 9.87 9.47 8 101831 595 63386588
Therapeutic response decreased 9.87 9.47 58 101781 61467 63325716
Blood pressure immeasurable 9.86 9.47 11 101828 1221 63385962
Myxoedema coma 9.84 9.47 7 101832 428 63386755
Repetitive strain injury 9.79 9.47 5 101834 166 63387017
Pallor 9.73 9.47 83 101756 30485 63356698
Cancer pain 9.70 9.47 18 101821 3187 63383996
Herpes zoster 9.69 9.47 186 101653 82276 63304907
Central venous catheterisation 9.69 9.47 16 101823 2583 63384600
Skin discolouration 9.67 9.47 98 101741 37730 63349453
Neuromuscular blockade 9.66 9.47 6 101833 292 63386891
Lack of infusion site rotation 9.65 9.47 3 101836 25 63387158
Allodynia 9.63 9.47 9 101830 810 63386373
Haematocrit increased 9.60 9.47 15 101824 2311 63384872
Grip strength decreased 9.60 9.47 13 101826 22274 63364909
Parainfluenzae virus infection 9.60 9.47 15 101824 2312 63384871
Myopathy 9.59 9.47 3 101836 11188 63375995
Haemorrhagic vasculitis 9.56 9.47 4 101835 83 63387100
Septic shock 9.56 9.47 65 101774 66564 63320619
Cerebral congestion 9.55 9.47 3 101836 26 63387157
Bladder spasm 9.52 9.47 13 101826 1775 63385408

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 397.65 10.39 131 51445 1469 34903886
Anaphylactic shock 289.07 10.39 217 51359 15724 34889631
Methaemoglobinaemia 244.64 10.39 115 51461 3466 34901889
Anaphylactic reaction 215.74 10.39 252 51324 32049 34873306
Anaesthetic complication 197.69 10.39 71 51505 1049 34904306
Local anaesthetic systemic toxicity 180.51 10.39 49 51527 261 34905094
Cardiac arrest 148.88 10.39 392 51184 95767 34809588
Product quality issue 145.04 10.39 151 51425 16884 34888471
Sinusitis 134.97 10.39 229 51347 41173 34864182
Toxic anterior segment syndrome 126.87 10.39 52 51524 1117 34904238
Ventricular tachycardia 93.27 10.39 152 51424 26427 34878928
Hypotension 91.28 10.39 599 50977 221050 34684305
Lagophthalmos 82.86 10.39 21 51555 81 34905274
Infusion site pain 80.14 10.39 57 51519 3794 34901561
Generalised tonic-clonic seizure 79.65 10.39 125 51451 21049 34884306
Toxicity to various agents 70.93 10.39 522 51054 199840 34705515
Electrocardiogram ST segment elevation 68.68 10.39 59 51517 5179 34900176
Fear 68.67 10.39 81 51495 10395 34894960
Infusion site swelling 68.39 10.39 44 51532 2480 34902875
Ventricular fibrillation 68.30 10.39 122 51454 22832 34882523
Injury 68.14 10.39 115 51461 20572 34884783
Infusion site extravasation 67.52 10.39 54 51522 4290 34901065
Emotional distress 62.57 10.39 93 51483 14933 34890422
Bradycardia 62.21 10.39 248 51328 75170 34830185
Ear infection 61.98 10.39 76 51500 10155 34895200
Renal injury 56.55 10.39 76 51500 11119 34894236
Anhedonia 55.36 10.39 62 51514 7523 34897832
Unresponsive to stimuli 54.96 10.39 124 51452 27445 34877910
Drug ineffective for unapproved indication 52.19 10.39 111 51465 23604 34881751
Pain 50.00 10.39 491 51085 204184 34701171
Retinal artery occlusion 48.96 10.39 32 51544 1853 34903502
Endophthalmitis 46.98 10.39 40 51536 3468 34901887
Infusion site erythema 45.82 10.39 33 51543 2240 34903115
Bronchospasm 45.51 10.39 67 51509 10664 34894691
Anaesthetic complication neurological 43.45 10.39 17 51559 322 34905033
Completed suicide 42.82 10.39 49 51527 98119 34807236
Hyperthermia malignant 42.50 10.39 31 51545 2146 34903209
Infusion site bruising 41.97 10.39 21 51555 727 34904628
Tachycardia 40.32 10.39 238 51338 84534 34820821
Therapy interrupted 38.45 10.39 71 51505 13626 34891729
Spinal cord infarction 38.15 10.39 15 51561 288 34905067
Embolia cutis medicamentosa 37.89 10.39 14 51562 225 34905130
Chemical burn 37.23 10.39 14 51562 237 34905118
Unevaluable event 36.97 10.39 119 51457 32471 34872884
Infusion site haemorrhage 36.17 10.39 21 51555 983 34904372
Overdose 36.07 10.39 244 51332 90815 34814540
Anal inflammation 36.06 10.39 23 51553 1277 34904078
Corneal oedema 35.25 10.39 23 51553 1328 34904027
Ventricular extrasystoles 34.66 10.39 63 51513 11945 34893410
Stress 34.59 10.39 111 51465 30236 34875119
Cauda equina syndrome 34.51 10.39 17 51559 569 34904786
Sinus tachycardia 34.50 10.39 78 51498 17282 34888073
Neurotoxicity 33.68 10.39 79 51497 17931 34887424
Hypoxia 33.17 10.39 165 51411 54930 34850425
Diarrhoea 32.85 10.39 393 51183 389519 34515836
Respiratory arrest 32.35 10.39 103 51473 27940 34877415
Mydriasis 31.87 10.39 46 51530 7191 34898164
Infusion site pruritus 31.75 10.39 18 51558 805 34904550
Wrong product administered 31.30 10.39 39 51537 5295 34900060
Oculocardiac reflex 31.19 10.39 9 51567 62 34905293
General physical health deterioration 30.98 10.39 92 51484 128177 34777178
Insurance issue 30.95 10.39 25 51551 2014 34903341
Acute kidney injury 30.66 10.39 295 51281 304693 34600662
Circulatory collapse 28.72 10.39 82 51494 20956 34884399
Kounis syndrome 28.31 10.39 26 51550 2492 34902863
SARS-CoV-2 test negative 28.18 10.39 18 51558 1002 34904353
Respiratory tract infection 28.06 10.39 78 51498 19634 34885721
Interstitial lung disease 28.01 10.39 33 51543 65249 34840106
Hypoxic-ischaemic encephalopathy 27.99 10.39 34 51542 4498 34900857
Incorrect route of product administration 27.63 10.39 65 51511 14780 34890575
Apnoea 27.39 10.39 41 51535 6623 34898732
Intracranial hypotension 26.98 10.39 11 51565 233 34905122
Delayed recovery from anaesthesia 26.87 10.39 16 51560 785 34904570
Accident 26.62 10.39 35 51541 5012 34900343
Weight decreased 26.57 10.39 152 51424 176149 34729206
Amaurosis 26.33 10.39 15 51561 677 34904678
Haemodynamic instability 26.27 10.39 49 51527 9474 34895881
Procedural complication 26.23 10.39 32 51544 4251 34901104
Removal of foreign body 25.83 10.39 7 51569 37 34905318
Seizure 25.75 10.39 252 51324 104605 34800750
Shock 25.37 10.39 86 51490 24093 34881262
Upper respiratory tract infection 25.09 10.39 106 51470 32953 34872402
COVID-19 24.52 10.39 197 51379 77353 34828002
Electrocardiogram QRS complex prolonged 24.37 10.39 33 51543 4861 34900494
Anal sphincter atony 24.33 10.39 8 51568 89 34905266
Brain stem syndrome 23.55 10.39 13 51563 552 34904803
Accidental overdose 23.25 10.39 74 51502 20066 34885289
Drug interaction 22.90 10.39 218 51358 225728 34679627
Foreign body 22.58 10.39 16 51560 1058 34904297
Reperfusion arrhythmia 22.42 10.39 7 51569 65 34905290
Infusion site nodule 22.22 10.39 8 51568 119 34905236
Blood pressure fluctuation 22.22 10.39 5 51571 25244 34880111
Type I hypersensitivity 21.57 10.39 17 51559 1322 34904033
Respiratory tract infection bacterial 21.21 10.39 19 51557 1763 34903592
Disease progression 21.04 10.39 85 51491 107992 34797363
Respiratory tract infection viral 20.86 10.39 22 51554 2495 34902860
Cardiotoxicity 20.76 10.39 33 51543 5615 34899740
Ophthalmoplegia 20.69 10.39 19 51557 1821 34903534
Drug ineffective 20.60 10.39 846 50730 455905 34449450
Tryptase increased 20.58 10.39 9 51567 228 34905127
Aqueous fibrin 20.47 10.39 6 51570 44 34905311
Proctalgia 20.43 10.39 33 51543 5690 34899665
Electrocardiogram T wave amplitude increased 20.12 10.39 6 51570 47 34905308
Respiratory depression 19.97 10.39 61 51515 16184 34889171
Loss of consciousness 19.96 10.39 198 51378 82469 34822886
Cyanosis 19.66 10.39 52 51524 12712 34892643
Decreased appetite 19.30 10.39 155 51421 166237 34739118
Infusion site irritation 19.27 10.39 9 51567 267 34905088
Post procedural complication 19.20 10.39 48 51528 11340 34894015
Anaphylactoid shock 19.18 10.39 10 51566 378 34904977
Skin infection 19.12 10.39 38 51538 7699 34897656
Chondrolysis 19.03 10.39 7 51569 111 34905244
Pancreatitis acute 18.77 10.39 9 51567 28132 34877223
Agranulocytosis 18.55 10.39 6 51570 23815 34881540
Melaena 18.51 10.39 15 51561 35365 34869990
Myocardial infarction 18.44 10.39 104 51472 120981 34784374
Administration site pain 18.38 10.39 9 51567 297 34905058
Leukopenia 18.30 10.39 41 51535 62815 34842540
Tracheitis 18.25 10.39 12 51564 702 34904653
Haemoglobin decreased 18.24 10.39 104 51472 120668 34784687
Paraplegia 18.24 10.39 22 51554 2889 34902466
Blindness 18.16 10.39 56 51520 14930 34890425
Administration site swelling 18.07 10.39 8 51568 209 34905146
Incorrect drug administration rate 18 10.39 17 51559 1688 34903667
Hepatic enzyme increased 17.58 10.39 19 51557 39061 34866294
Catecholamine crisis 17.38 10.39 5 51571 34 34905321
Psoriasis 17.32 10.39 19 51557 38793 34866562
Diabetic ketoacidosis 17.06 10.39 3 51573 18029 34887326
Anaemia 16.72 10.39 243 51333 233092 34672263
Application site alopecia 16.56 10.39 3 51573 0 34905355
Suicide attempt 16.53 10.39 20 51556 39096 34866259
Atrioventricular block complete 16.47 10.39 40 51536 9279 34896076
Neuromuscular blockade 16.45 10.39 8 51568 260 34905095
Drug intolerance 16.42 10.39 40 51536 59530 34845825
Blood pressure decreased 16.35 10.39 131 51445 51384 34853971
Croup infectious 16.35 10.39 9 51567 380 34904975
Surgery 16.33 10.39 52 51524 14105 34891250
Vitreous disorder 16.32 10.39 6 51570 95 34905260
Anxiety 16.32 10.39 221 51355 99207 34806148
Infusion site rash 16.18 10.39 10 51566 525 34904830
Vitreous floaters 16.10 10.39 23 51553 3562 34901793
Trigemino-cardiac reflex 15.70 10.39 7 51569 186 34905169
Diabetic retinal oedema 15.63 10.39 7 51569 188 34905167
Postoperative delirium 15.63 10.39 7 51569 188 34905167
Retinal vasculitis 15.58 10.39 9 51567 417 34904938
Myopathy toxic 15.35 10.39 10 51566 576 34904779
Procedural hypotension 15.33 10.39 12 51564 924 34904431
Tubulointerstitial nephritis 15.17 10.39 6 51570 21018 34884337
Otospondylomegaepiphyseal dysplasia 15.13 10.39 6 51570 118 34905237
Phaeochromocytoma crisis 15.02 10.39 5 51571 58 34905297
Laryngeal oedema 15.01 10.39 22 51554 3486 34901869
Injection site extravasation 14.90 10.39 20 51556 2922 34902433
Drug resistance 14.84 10.39 10 51566 25917 34879438
Injection site discharge 14.53 10.39 7 51569 223 34905132
Behaviour disorder 14.47 10.39 26 51550 4884 34900471
Procedural haemorrhage 14.47 10.39 18 51558 2439 34902916
Angina pectoris 14.39 10.39 15 51561 31348 34874007
Blood pressure systolic increased 14.33 10.39 8 51568 22944 34882411
Hyperaesthesia 14.27 10.39 25 51551 4605 34900750
Product contamination microbial 14.27 10.39 10 51566 650 34904705
Diabetes mellitus 14.12 10.39 30 51546 46843 34858512
Illness 14.09 10.39 48 51528 13481 34891874
Myalgia 14.05 10.39 70 51506 84040 34821315
Erythema 14.02 10.39 196 51380 88584 34816771
Arthritis infective 14.00 10.39 21 51555 3398 34901957
Hepatitis 13.98 10.39 9 51567 23895 34881460
Ventricular tachyarrhythmia 13.94 10.39 8 51568 366 34904989
Anterior chamber cell 13.92 10.39 8 51568 367 34904988
Miosis 13.83 10.39 38 51538 9497 34895858
Injection site joint infection 13.81 10.39 4 51572 28 34905327
Jaundice 13.79 10.39 16 51560 31866 34873489
Pulse absent 13.74 10.39 28 51548 5775 34899580
COVID-19 immunisation 13.74 10.39 7 51569 252 34905103
Vitritis 13.68 10.39 11 51565 880 34904475
Blood methaemoglobin present 13.68 10.39 4 51572 29 34905326
Coronary artery disease 13.66 10.39 32 51544 48273 34857082
Hypopyon 13.52 10.39 8 51568 388 34904967
Spinal operation 13.39 10.39 19 51557 2925 34902430
Hypoglycaemia 13.31 10.39 39 51537 54601 34850754
Spinal cord injury 13.26 10.39 9 51567 555 34904800
Hypoaesthesia oral 13.25 10.39 23 51553 4206 34901149
Administration site reaction 13.22 10.39 5 51571 86 34905269
Myokymia 13.17 10.39 5 51571 87 34905268
Cardiac procedure complication 13.07 10.39 6 51570 171 34905184
Drug-induced liver injury 12.99 10.39 14 51562 28818 34876537
Sleep deficit 12.96 10.39 9 51567 576 34904779
Seizure like phenomena 12.96 10.39 10 51566 754 34904601
International normalised ratio increased 12.87 10.39 32 51544 47295 34858060
Injection site pain 12.82 10.39 100 51476 38905 34866450
Pulseless electrical activity 12.80 10.39 31 51545 7180 34898175
Rheumatoid arthritis 12.79 10.39 23 51553 38215 34867140
Tonic convulsion 12.73 10.39 12 51564 1189 34904166
Cytokine release syndrome 12.70 10.39 67 51509 22810 34882545
Hepatotoxicity 12.69 10.39 8 51568 21477 34883878
Adrenergic syndrome 12.67 10.39 5 51571 97 34905258
Administration related reaction 12.62 10.39 5 51571 98 34905257
Oral lichen planus 12.57 10.39 6 51570 187 34905168
Burkholderia test positive 12.36 10.39 11 51565 1012 34904343
Procedural pain 12.36 10.39 24 51552 4782 34900573
Opisthotonus 12.31 10.39 8 51568 459 34904896
Ventricular arrhythmia 12.30 10.39 26 51550 5502 34899853
Prostate cancer 12.26 10.39 25 51551 39624 34865731
Cardiogenic shock 12.17 10.39 74 51502 26544 34878811
Oxygen saturation decreased 12.07 10.39 127 51449 53691 34851664
Application site erythema 12.01 10.39 16 51560 2320 34903035
Extradural abscess 12.01 10.39 10 51566 841 34904514
Diplopia 12.00 10.39 53 51523 16790 34888565
Stress cardiomyopathy 11.99 10.39 15 51561 2044 34903311
Loss of personal independence in daily activities 11.98 10.39 19 51557 33160 34872195
Administration site irritation 11.96 10.39 3 51573 11 34905344
Recalled product 11.82 10.39 7 51569 340 34905015
Oesophageal obstruction 11.69 10.39 8 51568 500 34904855
Vitreous detachment 11.64 10.39 10 51566 878 34904477
Application site irritation 11.58 10.39 9 51567 686 34904669
Penile vascular disorder 11.56 10.39 3 51573 13 34905342
Haematochezia 11.49 10.39 33 51543 46501 34858854
Disease recurrence 11.38 10.39 9 51567 21481 34883874
Posterior capsule rupture 11.38 10.39 3 51573 14 34905341
Contraindicated product administered 11.37 10.39 9 51567 21472 34883883
Bronchitis 11.36 10.39 103 51473 41860 34863495
Histamine level increased 11.27 10.39 4 51572 57 34905298
Treatment noncompliance 11.22 10.39 15 51561 28085 34877270
Chondromalacia 11.21 10.39 3 51573 15 34905340
Bladder cancer 11.17 10.39 5 51571 16273 34889082
Conjunctival scar 11.17 10.39 5 51571 134 34905221
Symblepharon 11.14 10.39 5 51571 135 34905220
Eye inflammation 11.11 10.39 15 51561 2203 34903152
Seasonal allergy 11.11 10.39 28 51548 6647 34898708
Oxidative stress 10.96 10.39 4 51572 62 34905293
Cerebral venous thrombosis 10.93 10.39 9 51567 745 34904610
Fear of eating 10.90 10.39 4 51572 63 34905292
Myotonic dystrophy 10.84 10.39 5 51571 144 34905211
Injection site ulcer 10.84 10.39 6 51570 256 34905099
Induration 10.83 10.39 10 51566 965 34904390
Urticaria 10.79 10.39 140 51436 62237 34843118
Macroglossia 10.73 10.39 7 51569 404 34904951
Torsade de pointes 10.73 10.39 29 51547 7180 34898175
Rhabdomyolysis 10.66 10.39 58 51518 68105 34837250
Pulmonary fibrosis 10.66 10.39 7 51569 18389 34886966
Sinus arrest 10.66 10.39 13 51563 1727 34903628
Asthenia 10.64 10.39 278 51298 244973 34660382
Headache 10.49 10.39 378 51198 200257 34705098
Long QT syndrome congenital 10.46 10.39 4 51572 71 34905284
Mean arterial pressure decreased 10.44 10.39 5 51571 157 34905198
Infusion related reaction 10.43 10.39 122 51454 52935 34852420
Inadequate analgesia 10.41 10.39 17 51559 2958 34902397

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 706.44 9.42 230 117573 2474 79624111
Local anaesthetic systemic toxicity 691.00 9.42 183 117620 871 79625714
Anaphylactic shock 487.32 9.42 413 117390 35583 79591002
Anaphylactic reaction 445.40 9.42 583 117220 83160 79543425
Anaesthetic complication 393.39 9.42 151 117652 2708 79623877
Toxic anterior segment syndrome 383.95 9.42 147 117656 2617 79623968
Cardiac arrest 331.99 9.42 764 117039 171332 79455253
Methaemoglobinaemia 262.54 9.42 139 117664 5418 79621167
Product quality issue 248.53 9.42 278 117525 33662 79592923
Lagophthalmos 220.84 9.42 62 117741 381 79626204
Completed suicide 171.72 9.42 74 117729 245693 79380892
Kounis syndrome 157.99 9.42 91 117712 4191 79622394
Synovitis 154.65 9.42 20 117783 150714 79475871
Contraindicated product administered 139.41 9.42 31 117772 157507 79469078
Generalised tonic-clonic seizure 138.99 9.42 240 117563 43670 79582915
Drug intolerance 137.47 9.42 113 117690 264006 79362579
Infusion site swelling 133.87 9.42 103 117700 7723 79618862
Bradycardia 132.40 9.42 471 117332 135086 79491499
Hand deformity 131.49 9.42 5 117798 103914 79522671
Infusion site pain 130.18 9.42 131 117672 14045 79612540
Hypotension 129.78 9.42 1101 116702 439216 79187369
Hepatic enzyme increased 129.10 9.42 54 117749 182556 79444029
Ventricular tachycardia 127.27 9.42 225 117578 41710 79584875
Therapy interrupted 124.65 9.42 190 117613 31151 79595434
Maternal exposure during delivery 123.00 9.42 53 117750 1293 79625292
Infusion site erythema 120.76 9.42 105 117698 9355 79617230
Sinusitis 120.67 9.42 590 117213 194911 79431674
Joint swelling 118.97 9.42 151 117652 288495 79338090
Anaesthetic complication neurological 114.26 9.42 41 117762 603 79625982
Pemphigus 113.04 9.42 9 117794 99573 79527012
Unresponsive to stimuli 112.19 9.42 252 117551 55536 79571049
Stress cardiomyopathy 111.47 9.42 108 117695 11058 79615527
General physical health deterioration 109.31 9.42 148 117655 275090 79351495
Anti-cyclic citrullinated peptide antibody positive 108.75 9.42 3 117800 83140 79543445
Corneal oedema 108.34 9.42 60 117743 2560 79624025
Infusion site pruritus 107.11 9.42 70 117733 4048 79622537
Infusion site extravasation 107.04 9.42 101 117702 10007 79616578
Fear 97.08 9.42 140 117663 21846 79604739
Ventricular fibrillation 96.49 9.42 171 117632 31755 79594830
Pericarditis 95.31 9.42 19 117784 104217 79522368
Bronchospasm 93.67 9.42 147 117656 24712 79601873
Endophthalmitis 91.59 9.42 76 117727 6352 79620233
Infusion site haemorrhage 91.33 9.42 61 117742 3659 79622926
Systemic lupus erythematosus 90.27 9.42 33 117770 121116 79505469
Glossodynia 90.07 9.42 21 117782 103316 79523269
Infusion site bruising 88.78 9.42 55 117748 2897 79623688
COVID-19 87.55 9.42 462 117341 157212 79469373
Seizure 87.47 9.42 527 117276 188307 79438278
Pulseless electrical activity 86.97 9.42 106 117697 14054 79612531
Cauda equina syndrome 86.45 9.42 42 117761 1361 79625224
Insurance issue 86.33 9.42 70 117733 5663 79620922
Embolia cutis medicamentosa 85.39 9.42 33 117770 603 79625982
Duodenal ulcer perforation 84.40 9.42 3 117800 66208 79560377
Toxicity to various agents 84.03 9.42 972 116831 420568 79206017
Helicobacter infection 82.89 9.42 5 117798 69699 79556886
Drug ineffective for unapproved indication 82.11 9.42 212 117591 51026 79575559
Renal injury 80.97 9.42 112 117691 16815 79609770
Body tinea 80.92 9.42 44 117759 1810 79624775
Retinal artery occlusion 80.84 9.42 54 117749 3240 79623345
Anhedonia 78.00 9.42 103 117700 14795 79611790
Rheumatoid factor positive 75.28 9.42 3 117800 59836 79566749
Extradural abscess 74.78 9.42 39 117764 1473 79625112
Arthropathy 74.66 9.42 91 117712 177020 79449565
Type I hypersensitivity 73.30 9.42 57 117746 4341 79622244
Emotional distress 73.15 9.42 174 117629 39795 79586790
Incorrect route of product administration 72.72 9.42 160 117643 34769 79591816
Alopecia 70.07 9.42 148 117655 231207 79395378
Rheumatoid arthritis 69.50 9.42 126 117677 208344 79418241
Apnoea 69.27 9.42 86 117717 11618 79614967
Therapeutic product effect decreased 69.27 9.42 84 117719 163779 79462806
Abdominal discomfort 67.39 9.42 171 117632 250556 79376029
Procedural hypotension 66.76 9.42 40 117763 1983 79624602
Unevaluable event 66.58 9.42 207 117596 55378 79571207
Pulse absent 65.93 9.42 78 117725 10025 79616560
Incorrect drug administration rate 64.55 9.42 51 117752 3975 79622610
Sinus tachycardia 62.56 9.42 156 117647 36752 79589833
Arthralgia 62.15 9.42 543 117260 571260 79055325
Illness 61.16 9.42 179 117624 46332 79580253
Seasonal allergy 60.40 9.42 96 117707 16310 79610275
Post procedural complication 59.96 9.42 118 117685 23711 79602874
Tachycardia 57.85 9.42 455 117348 177313 79449272
Ear infection 56.75 9.42 144 117659 34288 79592297
Ophthalmoplegia 55.74 9.42 41 117762 2871 79623714
Electrocardiogram ST segment elevation 55.08 9.42 65 117738 8332 79618253
Urinary tract infection 55.06 9.42 634 117169 273878 79352707
Neurotoxicity 53.60 9.42 136 117667 32382 79594203
Infection susceptibility increased 53.02 9.42 44 117759 3677 79622908
Wound 52.97 9.42 56 117747 116123 79510462
Diarrhoea 52.74 9.42 950 116853 879539 78747046
Hypopyon 52.35 9.42 28 117775 1114 79625471
Acute kidney injury 52.19 9.42 503 117300 518901 79107684
Spinal cord infarction 51.95 9.42 23 117780 600 79625985
Upper respiratory tract infection 51.86 9.42 269 117534 90899 79535686
Infusion site mass 51.28 9.42 31 117772 1562 79625023
Folliculitis 50.81 9.42 10 117793 55370 79571215
Respiratory tract infection 50.80 9.42 173 117630 48516 79578069
Paraplegia 50.67 9.42 49 117754 5004 79621581
Retinal vasculitis 50.57 9.42 29 117774 1324 79625261
Vitritis 50.37 9.42 32 117771 1762 79624823
Sleep disorder due to general medical condition, insomnia type 49.25 9.42 4 117799 43552 79583033
Hyperthermia malignant 49.03 9.42 38 117765 2879 79623706
Suicide attempt 48.95 9.42 31 117772 82901 79543684
Mydriasis 48.86 9.42 91 117712 17552 79609033
Surgery 48.86 9.42 132 117671 32634 79593951
Blood pressure decreased 48.85 9.42 282 117521 99184 79527401
Injury 48.55 9.42 235 117568 77261 79549324
Dermatitis contact 48.33 9.42 70 117733 10963 79615622
Systemic toxicity 48.25 9.42 15 117788 137 79626448
Inhibitory drug interaction 48.12 9.42 45 117758 4408 79622177
Procedural complication 47.80 9.42 59 117744 7924 79618661
Musculoskeletal stiffness 47.28 9.42 119 117684 174889 79451696
Purtscher retinopathy 46.67 9.42 14 117789 112 79626473
Loss of consciousness 45.69 9.42 413 117390 167530 79459055
Anterior chamber cell 45.57 9.42 24 117779 925 79625660
Aqueous fibrin 45.42 9.42 14 117789 124 79626461
Multiple allergies 45.29 9.42 66 117737 10394 79616191
Extradural haematoma 45.18 9.42 36 117767 2840 79623745
Nystagmus 45.09 9.42 64 117739 9840 79616745
Muscle injury 44.07 9.42 9 117794 48552 79578033
Anaphylactoid shock 44.01 9.42 22 117781 759 79625826
Removal of foreign body 43.27 9.42 12 117791 70 79626515
Psoriatic arthropathy 42.26 9.42 32 117771 77967 79548618
Shock 42.20 9.42 151 117652 43397 79583188
Paralysis 41.65 9.42 72 117731 13105 79613480
Hypoxia 41.48 9.42 278 117525 102965 79523620
Mobility decreased 41.46 9.42 73 117730 122102 79504483
Arthritis bacterial 41.39 9.42 59 117744 9107 79617478
Cyanosis 41.17 9.42 105 117698 25077 79601508
Sensory loss 41.09 9.42 71 117732 12920 79613665
Respiratory arrest 40.83 9.42 181 117622 57369 79569216
Chemical burn 40.34 9.42 19 117784 574 79626011
C-reactive protein abnormal 39.88 9.42 11 117792 48356 79578229
Bronchitis 39.56 9.42 329 117474 130315 79496270
COVID-19 immunisation 39.39 9.42 25 117778 1374 79625211
Circulatory collapse 38.56 9.42 133 117670 37535 79589050
Status epilepticus 38.47 9.42 102 117701 24939 79601646
Treatment failure 37.97 9.42 127 117676 170359 79456226
Fear of eating 37.96 9.42 17 117786 456 79626129
Ventricular extrasystoles 37.38 9.42 87 117716 19617 79606968
Accidental overdose 37.30 9.42 136 117667 39445 79587140
Nerve root injury 37.24 9.42 9 117794 27 79626558
Mental status changes 36.99 9.42 196 117607 66763 79559822
Diplopia 36.76 9.42 121 117682 33345 79593240
Anal sphincter atony 36.54 9.42 15 117788 323 79626262
Glucose tolerance impaired 36.45 9.42 52 117751 8032 79618553
Phrenic nerve paralysis 36.41 9.42 15 117788 326 79626259
Infusion site urticaria 36.33 9.42 22 117781 1112 79625473
Acute motor-sensory axonal neuropathy 36.29 9.42 16 117787 413 79626172
Tryptase increased 35.64 9.42 18 117785 635 79625950
Staphylococcal infection 35.24 9.42 175 117628 58120 79568465
Hepatotoxicity 34.98 9.42 16 117787 51336 79575249
Infusion site rash 34.94 9.42 25 117778 1677 79624908
Sopor 34.77 9.42 4 117799 33006 79593579
Product contamination microbial 34.62 9.42 20 117783 926 79625659
Therapy cessation 34.50 9.42 128 117675 37434 79589151
Myopathy toxic 34.40 9.42 21 117782 1077 79625508
Anal inflammation 34.03 9.42 23 117780 1407 79625178
Intentional self-injury 33.97 9.42 4 117799 32415 79594170
Delayed recovery from anaesthesia 33.03 9.42 24 117779 1649 79624936
Trigemino-cardiac reflex 32.74 9.42 13 117790 256 79626329
Pneumocephalus 32.55 9.42 14 117789 340 79626245
Lower respiratory tract infection 32.52 9.42 91 117712 129129 79497456
Drug resistance 32.29 9.42 11 117792 42202 79584383
Liver injury 32.27 9.42 22 117781 56592 79569993
Respiratory depression 32.25 9.42 102 117701 27528 79599057
Platelet aggregation inhibition 31.48 9.42 11 117792 149 79626436
Poor quality sleep 31.37 9.42 89 117714 22633 79603952
Peripheral nerve injury 31.31 9.42 17 117786 697 79625888
Rheumatic fever 31.22 9.42 3 117800 28522 79598063
Meningitis chemical 31.22 9.42 12 117791 216 79626369
Oculocardiac reflex 31.17 9.42 9 117794 62 79626523
Blood pressure fluctuation 31.01 9.42 32 117771 67113 79559472
Spinal anaesthesia 30.93 9.42 9 117794 64 79626521
Lactic acidosis 30.86 9.42 35 117768 70324 79556261
Wrong product administered 30.82 9.42 51 117752 8961 79617624
Amaurosis 30.38 9.42 20 117783 1171 79625414
Overdose 30.27 9.42 410 117393 183796 79442789
Tracheal deviation 30.16 9.42 11 117792 170 79626415
Spinal operation 30.08 9.42 47 117756 7870 79618715
Impaired healing 30.07 9.42 52 117751 87603 79538982
Application site rash 29.94 9.42 25 117778 2107 79624478
Hypoaesthesia oral 29.73 9.42 65 117738 14059 79612526
Visual acuity reduced 29.25 9.42 103 117700 29366 79597219
Cellulitis 29.04 9.42 267 117536 108793 79517792
Disease progression 28.92 9.42 157 117646 184205 79442380
Corneal epithelium defect 28.46 9.42 16 117787 703 79625882
Haemorrhoids 28.22 9.42 101 117702 29027 79597558
Eyelid ptosis 28.16 9.42 55 117748 10989 79615596
Drug reaction with eosinophilia and systemic symptoms 28.13 9.42 32 117771 64212 79562373
Type 2 diabetes mellitus 27.79 9.42 26 117777 57096 79569489
Anaphylactoid reaction 27.63 9.42 37 117766 5385 79621200
Infusion site discomfort 27.62 9.42 20 117783 1367 79625218
Infusion site irritation 27.38 9.42 16 117787 757 79625828
Pancreatitis acute 27.32 9.42 20 117783 49584 79577001
Intracranial hypotension 27.29 9.42 13 117790 403 79626182
Death 27.14 9.42 1058 116745 565456 79061129
Upper airway obstruction 27.10 9.42 20 117783 1408 79625177
Foreign body 27.04 9.42 27 117776 2867 79623718
Electrocardiogram QRS complex prolonged 26.48 9.42 53 117750 10780 79615805
Anxiety 26.19 9.42 514 117289 247998 79378587
Quadriparesis 26.17 9.42 29 117774 3472 79623113
Neuromuscular blockade 25.97 9.42 14 117789 566 79626019
Haemodynamic instability 25.89 9.42 70 117733 17312 79609273
Postoperative delirium 25.83 9.42 12 117791 351 79626234
Interstitial lung disease 25.67 9.42 83 117720 112517 79514068
Stress 25.45 9.42 203 117600 79409 79547176
Cardiotoxicity 25.40 9.42 56 117747 12183 79614402
Laryngeal oedema 25.15 9.42 44 117759 8085 79618500
Condition aggravated 24.41 9.42 559 117244 500565 79126020
Respiratory tract infection bacterial 24.41 9.42 22 117781 2055 79624530
Decreased appetite 24.18 9.42 358 117445 342060 79284525
Bursitis infective 24.15 9.42 18 117785 1286 79625299
Asthenia 24.03 9.42 574 117229 511115 79115470
Skin infection 23.77 9.42 70 117733 18175 79608410
Therapeutic product effect incomplete 23.69 9.42 118 117685 141527 79485058
Blood pressure systolic increased 23.66 9.42 39 117764 66947 79559638
Vasoplegia syndrome 23.64 9.42 28 117775 3602 79622983
SARS-CoV-2 test negative 23.35 9.42 18 117785 1353 79625232
Nerve block 23.27 9.42 14 117789 699 79625886
Neuromuscular block prolonged 23.17 9.42 16 117787 1014 79625571
Hepatitis 23.08 9.42 29 117774 55698 79570887
C-reactive protein increased 23.03 9.42 105 117698 128922 79497663
Miosis 22.93 9.42 63 117740 15726 79610859
Neutropenia 22.74 9.42 294 117509 287416 79339169
Ill-defined disorder 22.67 9.42 39 117764 65836 79560749
Haematochezia 22.59 9.42 61 117742 87584 79539001
Hypoxic-ischaemic encephalopathy 22.49 9.42 41 117762 7779 79618806
Brain stem syndrome 22.26 9.42 15 117788 913 79625672
Arthritis infective 22.08 9.42 42 117761 8229 79618356
Aspiration joint abnormal 22.08 9.42 4 117799 0 79626585
Swelling 22.07 9.42 209 117594 216502 79410083
Spinal cord oedema 21.89 9.42 11 117792 384 79626201
Parophthalmia 21.83 9.42 11 117792 386 79626199
Loss of personal independence in daily activities 21.76 9.42 78 117725 102502 79524083
Rash 21.65 9.42 670 117133 577688 79048897
Stridor 21.59 9.42 33 117770 5420 79621165
Normal newborn 21.52 9.42 38 117765 7034 79619551
Application site alopecia 21.49 9.42 5 117798 12 79626573
Abdominal pain upper 21.47 9.42 219 117584 223600 79402985
Product preparation error 21.46 9.42 34 117769 5759 79620826
Punctate keratitis 21.44 9.42 15 117788 971 79625614
Psoriasis 21.15 9.42 65 117738 89522 79537063
Peripheral swelling 21.12 9.42 276 117527 269341 79357244
Atonic urinary bladder 21.11 9.42 7 117796 80 79626505
Hypoglycaemia 21.05 9.42 78 117725 101516 79525069
Axillary nerve injury 20.94 9.42 5 117798 14 79626571
Hospitalisation 20.85 9.42 222 117581 94014 79532571
Glossoptosis 20.79 9.42 9 117794 222 79626363
Premature delivery 20.75 9.42 79 117724 23388 79603197
Spinal epidural haemorrhage 20.71 9.42 8 117795 146 79626439
Leukopenia 20.69 9.42 95 117708 116418 79510167
Cardiogenic shock 20.68 9.42 119 117684 41795 79584790
Impaired quality of life 20.49 9.42 57 117746 14329 79612256
Abortion spontaneous 20.40 9.42 9 117794 29498 79597087
Disease recurrence 20.39 9.42 21 117782 44088 79582497
Irritable bowel syndrome 20.38 9.42 38 117765 62203 79564382
Off label use 20.30 9.42 1115 116688 906100 78720485
Airway peak pressure increased 20.25 9.42 10 117793 336 79626249
Gastroenteritis viral 19.86 9.42 81 117722 24750 79601835
Trigeminal palsy 19.78 9.42 5 117798 19 79626566
Liver function test abnormal 19.70 9.42 41 117762 64434 79562151
Pulmonary oedema 19.56 9.42 208 117595 88046 79538539
Back pain 19.56 9.42 588 117215 303592 79322993
Product use issue 19.44 9.42 207 117596 209615 79416970
Procedural haemorrhage 19.37 9.42 29 117774 4677 79621908
Bone density decreased 19.13 9.42 53 117750 13294 79613291
Skin test positive 19.10 9.42 15 117788 1159 79625426
Tubulointerstitial nephritis 19.08 9.42 17 117786 38218 79588367
Jaundice 18.90 9.42 31 117772 53318 79573267
Foreign body in respiratory tract 18.76 9.42 10 117793 395 79626190
Erythema 18.76 9.42 447 117356 222843 79403742
Respiratory tract infection viral 18.62 9.42 27 117776 4232 79622353
Harlequin syndrome 18.55 9.42 6 117797 63 79626522
Opisthotonus 18.51 9.42 12 117791 684 79625901
Spinal epidural haematoma 18.49 9.42 16 117787 1416 79625169
Allodynia 18.47 9.42 17 117786 1631 79624954
Airway complication of anaesthesia 18.42 9.42 10 117793 410 79626175
Nerve injury 18.40 9.42 42 117761 9350 79617235
Melaena 18.37 9.42 39 117764 60851 79565734
Rhabdomyolysis 18.36 9.42 84 117719 103047 79523538
Inadequate analgesia 18.31 9.42 28 117775 4601 79621984
Pulmonary fibrosis 18.22 9.42 23 117780 44089 79582496
Blood cholesterol increased 18.20 9.42 63 117740 83657 79542928
Atrioventricular block complete 18.19 9.42 60 117743 16550 79610035
Pneumonia mycoplasmal 18.05 9.42 16 117787 1462 79625123
Treatment noncompliance 17.93 9.42 31 117772 52237 79574348
Red blood cell sedimentation rate increased 17.91 9.42 25 117778 45917 79580668
Intentional dose omission 17.91 9.42 40 117763 8777 79617808
Accident 17.87 9.42 40 117763 8791 79617794
Oral herpes 17.73 9.42 84 117719 27370 79599215
Blindness 17.72 9.42 86 117717 28297 79598288
Proctalgia 17.72 9.42 43 117760 9958 79616627
Injection site joint infection 17.64 9.42 5 117798 32 79626553
Ventricular hypokinesia 17.63 9.42 41 117762 9238 79617347
Respiratory acidosis 17.59 9.42 46 117757 11154 79615431
Application site erythema 17.58 9.42 29 117774 5081 79621504
Liver disorder 17.48 9.42 52 117751 72365 79554220
Underdose 17.45 9.42 14 117789 33137 79593448
Infusion site nodule 17.43 9.42 9 117794 333 79626252
Pupillary reflex impaired 17.27 9.42 23 117780 3330 79623255
Quadriplegia 17.23 9.42 23 117780 3337 79623248
Diabetic ketoacidosis 17.23 9.42 15 117788 34107 79592478
Dysarthria 17.22 9.42 164 117639 67458 79559127
Diplegia 17.18 9.42 17 117786 1786 79624799
Thrombocytopenia 17.13 9.42 282 117521 264977 79361608
Adverse event 16.99 9.42 40 117763 60174 79566411
Cytokine release syndrome 16.98 9.42 101 117702 35897 79590688
Chondrolysis 16.97 9.42 9 117794 352 79626233
Septic arthritis staphylococcal 16.85 9.42 12 117791 799 79625786
Bone erosion 16.85 9.42 3 117800 17844 79608741
Arthritis 16.84 9.42 100 117703 114780 79511805
Infusion related reaction 16.84 9.42 239 117564 229998 79396587
Streptococcal infection 16.76 9.42 39 117764 8791 79617794
Neuroleptic malignant syndrome 16.68 9.42 10 117793 27549 79599036
Vitreous disorder 16.65 9.42 8 117795 253 79626332
Removal of foreign body from respiratory tract 16.56 9.42 3 117800 0 79626585
Carotid pulse decreased 16.56 9.42 3 117800 0 79626585
Administration site swelling 16.52 9.42 10 117793 505 79626080
Weight decreased 16.50 9.42 399 117404 354799 79271786
Mean arterial pressure decreased 16.49 9.42 9 117794 373 79626212
Kidney infection 16.47 9.42 70 117733 21781 79604804
Irregular breathing 16.47 9.42 10 117793 508 79626077
Familial periodic paralysis 16.35 9.42 7 117796 168 79626417
Sleep disorder 16.34 9.42 68 117735 85609 79540976
Corneal abrasion 16.32 9.42 14 117789 1225 79625360
Drug-induced liver injury 16.30 9.42 47 117756 66070 79560515
Device ineffective 16.20 9.42 7 117796 172 79626413
Sinus bradycardia 16.12 9.42 77 117726 25170 79601415
Product dose omission issue 16.04 9.42 479 117324 247058 79379527
Supraventricular tachycardia 15.92 9.42 68 117735 21202 79605383
Obesity 15.92 9.42 17 117786 35108 79591477
Implant site bruising 15.82 9.42 8 117795 283 79626302
Coronary artery disease 15.81 9.42 47 117756 65427 79561158
Nail bed tenderness 15.81 9.42 9 117794 405 79626180
Poor quality product administered 15.78 9.42 23 117780 3622 79622963
Spinal cord injury 15.78 9.42 14 117789 1281 79625304
Catecholamine crisis 15.77 9.42 5 117798 49 79626536
Meningitis 15.71 9.42 40 117763 9542 79617043
Blood creatinine increased 15.58 9.42 150 117653 154907 79471678
Behaviour disorder 15.57 9.42 31 117772 6282 79620303
Symblepharon 15.42 9.42 7 117796 194 79626391
Angioedema 15.38 9.42 176 117627 75859 79550726
Spinal cord compression 15.35 9.42 31 117772 6346 79620239
Orthostatic hypotension 15.30 9.42 38 117765 56126 79570459
Retinal haemorrhage 15.28 9.42 36 117767 8181 79618404
Type IV hypersensitivity reaction 15.19 9.42 24 117779 4057 79622528
Abdominal pain 15.12 9.42 449 117354 389120 79237465
Bladder cancer 15.09 9.42 5 117798 19521 79607064
International normalised ratio increased 15.08 9.42 69 117734 84652 79541933
Paranasal cyst 15.02 9.42 9 117794 446 79626139
Product prescribing error 14.99 9.42 27 117776 44786 79581799
Incision site rash 14.94 9.42 4 117799 20 79626565
Cytomegalovirus infection 14.90 9.42 25 117778 42619 79583966
Prescribed underdose 14.87 9.42 13 117790 29501 79597084
Vitamin D increased 14.87 9.42 10 117793 607 79625978
Chorea 14.69 9.42 18 117785 2399 79624186
Cholestasis of pregnancy 14.69 9.42 12 117791 981 79625604
Gastrointestinal disorder 14.61 9.42 113 117690 122092 79504493
Blepharoplasty 14.48 9.42 3 117800 3 79626582
Removal of foreign body from throat 14.48 9.42 3 117800 3 79626582
Nerve root injury cervical 14.48 9.42 3 117800 3 79626582
Injection site discharge 14.46 9.42 11 117792 811 79625774
Sinus arrest 14.46 9.42 22 117781 3600 79622985
Procedural pain 14.45 9.42 70 117733 23014 79603571
Cholestasis 14.40 9.42 35 117768 52074 79574511
Infusion site warmth 14.38 9.42 14 117789 1441 79625144
Piloerection 14.21 9.42 9 117794 493 79626092
Cardiac failure congestive 14.21 9.42 138 117665 142264 79484321
Product administration error 14.16 9.42 88 117715 31758 79594827
Apnoeic attack 14.07 9.42 10 117793 664 79625921
Eye infection 13.91 9.42 44 117759 11876 79614709
Long QT syndrome congenital 13.75 9.42 6 117797 151 79626434
Foetal heart rate abnormal 13.74 9.42 8 117795 376 79626209
Vitreous floaters 13.72 9.42 32 117771 7224 79619361
Discomfort 13.72 9.42 119 117684 125498 79501087
Oxidative stress 13.68 9.42 4 117799 29 79626556
Infusion site reaction 13.64 9.42 21 117782 3472 79623113
Ocular retrobulbar haemorrhage 13.57 9.42 6 117797 156 79626429
Vascular malformation 13.47 9.42 8 117795 390 79626195
Uterine hypertonus 13.43 9.42 7 117796 264 79626321
Skin disorder 13.39 9.42 91 117712 33852 79592733
Administration site pain 13.28 9.42 9 117794 553 79626032
Application site oedema 13.27 9.42 5 117798 85 79626500
Hallucination, auditory 13.25 9.42 7 117796 20686 79605899
Product contamination physical 13.23 9.42 6 117797 166 79626419
Vaginal abscess 13.22 9.42 8 117795 404 79626181
Chills 13.22 9.42 320 117483 159914 79466671
Tooth infection 13.18 9.42 59 117744 18773 79607812
Seizure like phenomena 13.16 9.42 15 117788 1852 79624733
Progressive multifocal leukoencephalopathy 13.15 9.42 7 117796 20593 79605992
Anal ulcer 13.14 9.42 13 117790 1365 79625220
Prostate cancer 13.07 9.42 18 117785 33250 79593335
Spinal cord ischaemia 13.06 9.42 6 117797 171 79626414
Spinal stroke 13.02 9.42 4 117799 35 79626550
Monoplegia 12.95 9.42 22 117781 3949 79622636
Liquid product physical issue 12.95 9.42 12 117791 1162 79625423
Eye inflammation 12.92 9.42 29 117774 6384 79620201
Oesophageal adenocarcinoma recurrent 12.92 9.42 4 117799 36 79626549
Intentional product misuse to child 12.91 9.42 5 117798 92 79626493
Myelosuppression 12.84 9.42 25 117778 40271 79586314
Myocardial infarction 12.81 9.42 193 117610 183936 79442649
Reperfusion arrhythmia 12.76 9.42 7 117796 293 79626292
Hypoventilation 12.73 9.42 31 117772 7193 79619392
Hemiplegic migraine 12.66 9.42 5 117798 97 79626488
Application site vesicles 12.66 9.42 13 117790 1427 79625158
Air embolism 12.62 9.42 8 117795 439 79626146
Blood pressure diastolic increased 12.58 9.42 3 117800 14539 79612046
Histamine level increased 12.57 9.42 5 117798 99 79626486
Retinal detachment 12.55 9.42 36 117767 9211 79617374
Femoral nerve injury 12.54 9.42 4 117799 40 79626545
Application site pain 12.54 9.42 24 117779 4723 79621862
Scar 12.49 9.42 50 117753 15146 79611439
Premature baby 12.40 9.42 21 117782 3759 79622826
Injection site necrosis 12.38 9.42 13 117790 1465 79625120
Hepatocellular injury 12.35 9.42 33 117770 47560 79579025
Heliotrope rash 12.31 9.42 6 117797 196 79626389
Body dysmorphic disorder 12.24 9.42 7 117796 318 79626267
Intentional overdose 12.19 9.42 99 117704 105861 79520724
Testicular torsion 12.17 9.42 3 117800 10 79626575
Anal skin tags 12.14 9.42 8 117795 469 79626116
Bundle branch block left 12.09 9.42 41 117762 11472 79615113
Device infusion issue 12.05 9.42 16 117787 2310 79624275
Pallor 12.05 9.42 120 117683 49942 79576643
Pharyngitis streptococcal 12.00 9.42 39 117764 10675 79615910
Syringomyelia 11.92 9.42 6 117797 210 79626375
Lumbar spinal stenosis 11.91 9.42 25 117778 5257 79621328
Hypercholesterolaemia 11.85 9.42 10 117793 23085 79603500
Intra-ocular injection complication 11.81 9.42 4 117799 49 79626536
Respiratory tract oedema 11.76 9.42 10 117793 864 79625721
Allergic reaction to excipient 11.72 9.42 7 117796 345 79626240
Tracheitis 11.70 9.42 12 117791 1316 79625269
Myokymia 11.68 9.42 5 117798 120 79626465
Product administered at inappropriate site 11.67 9.42 21 117782 3944 79622641
Epidural analgesia 11.67 9.42 4 117799 51 79626534
Blood creatine phosphokinase increased 11.66 9.42 54 117749 66036 79560549
Anaemia 11.63 9.42 538 117265 444477 79182108
Inflammation 11.53 9.42 86 117717 93667 79532918
Metastases to liver 11.45 9.42 15 117788 28299 79598286
Pneumocystis jirovecii pneumonia 11.41 9.42 19 117784 32489 79594096
Infusion site streaking 11.40 9.42 8 117795 520 79626065
Accelerated idioventricular rhythm 11.40 9.42 6 117797 231 79626354
Injection site oedema 11.38 9.42 12 117791 1359 79625226
Hyperkalaemia 11.35 9.42 111 117692 114287 79512298
Respiratory distress 11.34 9.42 134 117669 58205 79568380
Full blood count abnormal 11.33 9.42 27 117776 40447 79586138
Administration related reaction 11.30 9.42 6 117797 235 79626350
Injection site ulcer 11.30 9.42 9 117794 710 79625875
Viral infection 11.28 9.42 105 117698 42911 79583674
Coccygectomy 11.20 9.42 3 117800 15 79626570
Conjunctival oedema 11.18 9.42 11 117792 1147 79625438
Injection site infection 11.13 9.42 15 117788 2197 79624388
Strabismus 11.05 9.42 16 117787 2505 79624080
Transferrin decreased 11.04 9.42 7 117796 384 79626201
Photosensitivity reaction 11.02 9.42 9 117794 21118 79605467
Induration 11.00 9.42 14 117789 1938 79624647
Gastroenteritis 10.99 9.42 21 117782 34061 79592524
Cardio-respiratory arrest 10.94 9.42 223 117580 108287 79518298
Decubitus ulcer 10.87 9.42 49 117754 15638 79610947
Environmental exposure 10.86 9.42 7 117796 395 79626190
Joint stiffness 10.83 9.42 28 117775 40802 79585783
Procedural anxiety 10.79 9.42 9 117794 757 79625828
Myotonic dystrophy 10.77 9.42 5 117798 146 79626439
Ventricular tachyarrhythmia 10.74 9.42 7 117796 403 79626182
Hypersensitivity 10.73 9.42 300 117503 261939 79364646
Exophthalmos 10.70 9.42 13 117790 1717 79624868
Left ventricle outflow tract obstruction 10.69 9.42 7 117796 406 79626179
Hyperaesthesia 10.68 9.42 41 117762 12181 79614404
Gamma-glutamyltransferase increased 10.67 9.42 43 117760 54637 79571948
Intraocular pressure fluctuation 10.67 9.42 4 117799 67 79626518
Adrenergic syndrome 10.65 9.42 5 117798 150 79626435
Arachnoiditis 10.62 9.42 9 117794 774 79625811
Drug tolerance decreased 10.61 9.42 3 117800 12975 79613610
Repetitive strain injury 10.59 9.42 5 117798 152 79626433
Inappropriate antidiuretic hormone secretion 10.58 9.42 14 117789 26299 79600286
Urticaria 10.58 9.42 353 117450 184848 79441737
Injection site atrophy 10.57 9.42 7 117796 414 79626171
Gastrointestinal haemorrhage 10.56 9.42 154 117649 147565 79479020
Angina pectoris 10.53 9.42 40 117763 51692 79574893
Foot deformity 10.53 9.42 12 117791 24062 79602523
Drug level increased 10.51 9.42 97 117706 39554 79587031
Injection site ischaemia 10.48 9.42 3 117800 20 79626565
Complex regional pain syndrome 10.47 9.42 14 117789 2034 79624551
Corneal opacity 10.43 9.42 10 117793 1010 79625575
Vascular stenosis 10.42 9.42 8 117795 598 79625987
Product contamination 10.40 9.42 11 117792 1249 79625336
Incontinence 10.39 9.42 45 117758 14119 79612466
Oesophageal obstruction 10.38 9.42 10 117793 1016 79625569
Hallucination, tactile 10.38 9.42 8 117795 601 79625984
Aphasia 10.29 9.42 110 117693 46622 79579963
Endotracheal intubation complication 10.24 9.42 9 117794 813 79625772
Incorrect product administration duration 10.24 9.42 40 117763 11982 79614603
Lip dry 10.20 9.42 5 117798 15413 79611172
Muscle rigidity 10.17 9.42 57 117746 19825 79606760
Small intestinal obstruction 10.10 9.42 72 117731 27200 79599385
Cataract 10.08 9.42 138 117665 61982 79564603
Pharyngitis 10.06 9.42 62 117741 22313 79604272
Intentional product use issue 10.05 9.42 161 117642 151951 79474634
Anterior chamber fibrin 10.04 9.42 5 117798 171 79626414
Incision site swelling 10.00 9.42 6 117797 298 79626287
Purpura 10.00 9.42 56 117747 19471 79607114
Injection site vesicles 9.99 9.42 17 117786 3055 79623530
Weight increased 9.95 9.42 323 117480 277063 79349522
Hepatitis cholestatic 9.94 9.42 4 117799 13848 79612737
Hyponatraemia 9.92 9.42 194 117609 177654 79448931
Orbital infection 9.88 9.42 4 117799 83 79626502
Drug hypersensitivity 9.88 9.42 538 117265 298378 79328207
Acute generalised exanthematous pustulosis 9.87 9.42 51 117752 17203 79609382
Intraocular pressure increased 9.86 9.42 33 117770 9172 79617413
Impaired work ability 9.79 9.42 56 117747 19625 79606960
Fatigue 9.75 9.42 1214 116589 928513 78698072
Agitation 9.74 9.42 204 117599 99511 79527074
Ventricular arrhythmia 9.74 9.42 32 117771 8808 79617777
Hyperlipidaemia 9.73 9.42 69 117734 26024 79600561
Skin depigmentation 9.72 9.42 10 117793 1100 79625485
Hypercalcaemia 9.71 9.42 27 117776 38403 79588182
Agranulocytosis 9.71 9.42 34 117769 44996 79581589
Tenderness 9.69 9.42 64 117739 23578 79603007
Medical device site pain 9.67 9.42 6 117797 317 79626268
Propionibacterium infection 9.60 9.42 6 117797 321 79626264
Product distribution issue 9.58 9.42 11 117792 1369 79625216
Chorioretinopathy 9.55 9.42 14 117789 2217 79624368
Infusion site induration 9.54 9.42 10 117793 1125 79625460
Non-infectious endophthalmitis 9.53 9.42 6 117797 325 79626260
Acute pulmonary oedema 9.52 9.42 44 117759 14186 79612399
Myelitis transverse 9.49 9.42 13 117790 1934 79624651
Immunisation reaction 9.46 9.42 7 117796 495 79626090
Blood pressure systolic abnormal 9.44 9.42 7 117796 17240 79609345

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 67.18 54.14 13 24 68 89687

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 | Suggest Off label Use Form| |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




🐶 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

🐶 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 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
2623 IUPHAR_LIGAND_ID
4202 INN_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
1269131003 SNOMEDCT_US
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 0054-0548 SOLUTION 20 mg ORAL ANDA 20 sections
Lidocaine Viscous HUMAN PRESCRIPTION DRUG LABEL 1 0054-3500 SOLUTION 20 mg ORAL ANDA 20 sections
Lidocaine 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
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 0113-7219 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 Pain Relief HUMAN OTC DRUG LABEL 1 0121-0970 PATCH 560 mg TOPICAL OTC monograph not final 14 sections
Lidocaine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0121-0972 SOLUTION 40 mg TOPICAL ANDA 21 sections
ABREVARapid Pain Relief HUMAN OTC DRUG LABEL 2 0135-0400 GEL 40 mg TOPICAL OTC monograph final 14 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 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 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