prilocaine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
local anaesthetics 2265 721-50-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • propitocaine hydrochloride
  • prilocaine
  • propitocaine
  • (+/-)-Prilocaine
  • prilocaine hydrochloride
  • propitocaine HCl
  • prilocaine HCl
A local anesthetic that is similar pharmacologically to LIDOCAINE. Currently, it is used most often for infiltration anesthesia in dentistry.
  • Molecular weight: 220.32
  • Formula: C13H20N2O
  • CLOGP: 1.81
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 41.13
  • ALOGS: -2.83
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

None

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 33.51 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 3.70 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 29 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.72 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.80 hours Lombardo F, Berellini G, Obach RS
BA (Bioavailability) 30 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAPK7,MET,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,SIK2,SIK3,TEK 26
kinase-selectivity-class AXL,BRAF,DDR1,ERBB2,GRK2,PDK4 6
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1

Approvals:

DateAgencyCompanyOrphan
Nov. 18, 1965 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Local anaesthetic systemic toxicity 882.43 9.41 253 74380 3247 90550567
Anaphylactic reaction 342.93 9.41 391 74242 87133 90466681
Maternal exposure during delivery 326.71 9.41 122 74511 3724 90550090
Cardiac arrest 253.61 9.41 369 74264 104566 90449248
Anaphylactic shock 244.27 9.41 205 74428 31412 90522402
Toxic anterior segment syndrome 226.89 9.41 81 74552 2169 90551645
Pemphigus 214.22 9.41 14 74619 326850 90226964
Hand deformity 209.09 9.41 8 74625 296354 90257460
Glossodynia 193.71 9.41 20 74613 321759 90232055
Synovitis 192.19 9.41 23 74610 329729 90224085
Systemic lupus erythematosus 190.68 9.41 34 74599 361862 90191952
Methaemoglobinaemia 175.06 9.41 79 74554 3936 90549878
Kounis syndrome 174.01 9.41 69 74564 2484 90551330
Contraindicated product administered 171.00 9.41 29 74604 320110 90233704
Anti-cyclic citrullinated peptide antibody positive 164.66 9.41 7 74626 236426 90317388
Pericarditis 154.57 9.41 20 74613 270131 90283683
Sinusitis 152.95 9.41 623 74010 342465 90211349
Duodenal ulcer perforation 152.62 9.41 7 74626 221281 90332533
Hepatic enzyme increased 151.40 9.41 54 74579 360682 90193132
Joint swelling 150.08 9.41 117 74516 503183 90050631
Hypotension 144.33 9.41 590 74043 324807 90229007
Infusion site pain 142.26 9.41 123 74510 19615 90534199
Generalised tonic-clonic seizure 136.72 9.41 156 74477 34747 90519067
Wound 134.76 9.41 41 74592 302939 90250875
Arthropathy 132.68 9.41 68 74565 366174 90187640
Infusion site swelling 131.94 9.41 95 74538 11625 90542189
Anaesthetic complication 128.51 9.41 55 74578 2410 90551404
Folliculitis 122.16 9.41 13 74620 204340 90349474
Helicobacter infection 120.10 9.41 21 74612 226829 90326985
Insurance issue 119.21 9.41 87 74546 10871 90542943
Stress cardiomyopathy 116.59 9.41 93 74540 13262 90540552
Rheumatoid factor positive 110.50 9.41 8 74625 171642 90382172
Infusion site erythema 110.48 9.41 91 74542 13579 90540235
Infusion site extravasation 110.10 9.41 81 74552 10247 90543567
Bradycardia 105.31 9.41 221 74412 83626 90470188
Infusion site pruritus 105.23 9.41 67 74566 6698 90547116
General physical health deterioration 103.95 9.41 84 74549 355031 90198783
Liver injury 101.56 9.41 11 74622 170556 90383258
Pulseless electrical activity 99.63 9.41 72 74561 8860 90544954
Rheumatic fever 98.95 9.41 7 74626 153114 90400700
Muscle injury 98.82 9.41 14 74619 176640 90377174
Impaired healing 94.94 9.41 37 74596 234162 90319652
Psoriatic arthropathy 92.68 9.41 36 74597 228299 90325515
Therapeutic product effect decreased 92.62 9.41 57 74576 277514 90276300
Abdominal discomfort 91.45 9.41 158 74475 477170 90076644
Alopecia 91.14 9.41 168 74465 494903 90058911
Urinary tract infection 89.19 9.41 491 74142 305141 90248673
Blister 86.98 9.41 51 74582 254947 90298867
COVID-19 85.16 9.41 319 74314 168524 90385290
Seizure 83.42 9.41 296 74337 152333 90401481
Type 2 diabetes mellitus 80.91 9.41 33 74600 203211 90350603
Illness 80.54 9.41 196 74437 81773 90472041
Toxicity to various agents 80.36 9.41 457 74176 287389 90266425
Infusion site haemorrhage 77.79 9.41 51 74582 5360 90548454
Sleep disorder due to general medical condition, insomnia type 77.37 9.41 8 74625 128686 90425128
Infusion site bruising 74.80 9.41 46 74587 4326 90549488
Procedural hypotension 74.61 9.41 33 74600 1567 90552247
Product dose omission issue 72.36 9.41 449 74184 291238 90262576
Mobility decreased 70.03 9.41 62 74571 250672 90303142
Pulse absent 67.97 9.41 49 74584 6006 90547808
Swollen joint count increased 66.63 9.41 7 74626 111199 90442615
Corneal oedema 66.13 9.41 32 74601 1869 90551945
Irritable bowel syndrome 65.91 9.41 45 74588 207403 90346411
Bronchitis 65.08 9.41 274 74359 152653 90401161
Rheumatoid arthritis 64.96 9.41 125 74508 362489 90191325
Anaesthetic complication neurological 64.74 9.41 24 74609 717 90553097
Ill-defined disorder 63.01 9.41 37 74596 184854 90368960
Incorrect drug administration rate 62.63 9.41 44 74589 5179 90548635
Apnoea 62.50 9.41 56 74577 9358 90544456
Seasonal allergy 61.63 9.41 85 74548 22898 90530916
Lip dry 61.40 9.41 6 74627 100949 90452865
Drug intolerance 61.27 9.41 178 74455 447413 90106401
C-reactive protein abnormal 60.81 9.41 15 74618 127414 90426400
Sulphaemoglobinaemia 60.67 9.41 21 74612 512 90553302
Swelling 58.57 9.41 165 74468 418893 90134921
Respiratory tract infection 57.74 9.41 141 74492 58937 90494877
Infusion site urticaria 57.05 9.41 28 74605 1687 90552127
Peripheral venous disease 56.73 9.41 3 74630 83918 90469896
Systemic toxicity 56.58 9.41 17 74616 259 90553555
Ventricular tachycardia 55.48 9.41 84 74549 24624 90529190
Staphylococcal infection 55.44 9.41 123 74510 48316 90505498
Upper respiratory tract infection 55.44 9.41 231 74402 128087 90425727
Ventricular fibrillation 55.38 9.41 63 74570 13981 90539833
Product adhesion issue 54.07 9.41 40 74593 5102 90548712
Hypersensitivity 53.75 9.41 193 74440 454484 90099330
Emotional distress 53.63 9.41 103 74530 36559 90517255
Musculoskeletal stiffness 53.29 9.41 102 74531 296430 90257384
Unresponsive to stimuli 53.20 9.41 105 74528 38016 90515798
Lower respiratory tract infection 52.62 9.41 78 74555 250581 90303233
Fear 51.53 9.41 66 74567 16556 90537258
Bursitis 51.38 9.41 22 74611 131632 90422182
Dermatitis contact 50.27 9.41 59 74574 13536 90540278
Mental status changes 49.51 9.41 112 74521 44567 90509247
Extradural haematoma 49.32 9.41 27 74606 2041 90551773
Extradural abscess 48.56 9.41 23 74610 1281 90552533
Inappropriate schedule of product administration 48.54 9.41 248 74385 149685 90404129
Drug ineffective for unapproved indication 47.93 9.41 142 74491 66502 90487312
Stomatitis 46.35 9.41 98 74535 274600 90279214
Inflammation 45.39 9.41 48 74585 178544 90375270
Completed suicide 45.36 9.41 32 74601 145026 90408788
Blood cholesterol increased 44.37 9.41 64 74569 207948 90345866
Headache 44.22 9.41 974 73659 861772 89692042
Ear infection 43.98 9.41 142 74491 69633 90484181
Lagophthalmos 43.87 9.41 16 74617 456 90553358
Anterior chamber cell 43.65 9.41 18 74615 718 90553096
Gait inability 43.61 9.41 34 74599 146422 90407392
Peripheral nerve injury 43.58 9.41 18 74615 721 90553093
Status epilepticus 43.56 9.41 65 74568 18809 90535005
Type I hypersensitivity 42.97 9.41 32 74601 4123 90549691
Infusion site mass 42.55 9.41 25 74608 2164 90551650
Obesity 42.19 9.41 17 74616 105490 90448324
Bronchospasm 41.75 9.41 67 74566 20642 90533172
Endophthalmitis 41.69 9.41 33 74600 4652 90549162
Liver disorder 41.69 9.41 24 74609 121245 90432569
Treatment failure 41.45 9.41 121 74512 303807 90250007
Administration site pain 41.32 9.41 20 74613 1169 90552645
Tachycardia 41.13 9.41 246 74387 157427 90396387
Premature delivery 40.56 9.41 95 74538 38667 90515147
Sleep disorder 40.23 9.41 63 74570 197967 90355847
Hypopyon 39.90 9.41 18 74615 896 90552918
Spinal epidural haematoma 39.14 9.41 20 74613 1314 90552500
Embolia cutis medicamentosa 39.07 9.41 16 74617 627 90553187
Spinal epidural haemorrhage 38.73 9.41 13 74620 288 90553526
Kidney infection 38.13 9.41 73 74560 25843 90527971
Abdominal pain upper 38.11 9.41 143 74490 332531 90221283
Infusion site rash 37.16 9.41 24 74609 2459 90551355
Renal injury 37.12 9.41 44 74589 10199 90543615
Infusion site nodule 37.01 9.41 21 74612 1702 90552112
Paraplegia 36.91 9.41 27 74606 3385 90550429
Grip strength decreased 36.88 9.41 15 74618 92561 90461253
Bursitis infective 36.80 9.41 20 74613 1490 90552324
Unevaluable event 36.74 9.41 114 74519 54734 90499080
Respiratory depression 36.46 9.41 54 74579 15521 90538293
Pneumocephalus 36.13 9.41 12 74621 257 90553557
Neurotoxicity 36.03 9.41 64 74569 21403 90532411
Adjustment disorder with depressed mood 35.51 9.41 3 74630 56750 90497064
Infusion site discharge 35.12 9.41 23 74610 2412 90551402
Drug hypersensitivity 34.87 9.41 231 74402 463378 90090436
Anhedonia 34.83 9.41 45 74588 11386 90542428
Multiple allergies 34.72 9.41 52 74581 15094 90538720
Deep vein thrombosis postoperative 34.44 9.41 8 74625 70801 90483013
Prescribed underdose 33.59 9.41 10 74623 75009 90478805
Vascular malformation 33.43 9.41 15 74618 737 90553077
Sinus tachycardia 33.30 9.41 73 74560 28440 90525374
Cauda equina syndrome 33.02 9.41 18 74615 1349 90552465
Vitritis 32.87 9.41 19 74614 1595 90552219
Fibromyalgia 32.80 9.41 76 74557 206193 90347621
Stridor 32.79 9.41 29 74604 4764 90549050
Back pain 32.67 9.41 402 74231 316773 90237041
Hypoxia 32.57 9.41 132 74501 72267 90481547
Paranasal cyst 32.36 9.41 15 74618 795 90553019
Pulmonary fibrosis 31.95 9.41 25 74608 107478 90446336
Anal skin tags 31.63 9.41 14 74619 666 90553148
Administration site swelling 31.47 9.41 18 74615 1481 90552333
Meningitis chemical 31.26 9.41 11 74622 282 90553532
Parophthalmia 30.82 9.41 12 74621 411 90553403
Chills 30.71 9.41 200 74433 131781 90422033
Arthralgia 30.67 9.41 454 74179 778068 89775746
Fear of eating 30.58 9.41 12 74621 420 90553394
Epidural haemorrhage 30.51 9.41 11 74622 303 90553511
C-reactive protein increased 30.34 9.41 65 74568 181324 90372490
Stress 30.18 9.41 140 74493 81255 90472559
Nail disorder 30.10 9.41 6 74627 59061 90494753
Product use issue 29.79 9.41 155 74478 329764 90224050
Confusional state 29.76 9.41 191 74442 386014 90167800
Purtscher retinopathy 29.72 9.41 9 74624 141 90553673
Infusion related reaction 29.68 9.41 211 74422 416569 90137245
Osteoarthritis 29.63 9.41 74 74559 195656 90358158
Corneal epithelium defect 29.09 9.41 12 74621 479 90553335
Condition aggravated 29.07 9.41 332 74301 595213 89958601
Cardiogenic shock 28.98 9.41 63 74570 24405 90529409
Ophthalmoplegia 28.90 9.41 18 74615 1731 90552083
Wound infection 28.86 9.41 27 74606 106375 90447439
Bundle branch block left 28.79 9.41 34 74599 7851 90545963
Incorrect route of product administration 28.33 9.41 99 74534 50527 90503287
Spinal cord compression 28.31 9.41 27 74606 4884 90548930
Discomfort 28.21 9.41 123 74510 274212 90279602
Musculoskeletal pain 28.12 9.41 62 74571 171189 90382625
Hypercholesterolaemia 28.08 9.41 25 74608 100867 90452947
Joint range of motion decreased 27.69 9.41 43 74590 135600 90418214
Platelet aggregation inhibition 27.67 9.41 9 74624 180 90553634
Blepharospasm 27.49 9.41 6 74627 55439 90498375
Diplopia 27.49 9.41 68 74565 28646 90525168
Prescribed overdose 27.40 9.41 24 74609 97601 90456213
Lung disorder 27.39 9.41 51 74582 149832 90403982
Hepatitis 27.31 9.41 12 74621 70727 90483087
Septic arthritis staphylococcal 27.22 9.41 12 74621 565 90553249
Aqueous fibrin 27.06 9.41 8 74625 115 90553699
Hypoaesthesia oral 26.82 9.41 47 74586 15553 90538261
Anxiety 26.64 9.41 380 74253 309392 90244422
Localised infection 26.53 9.41 74 74559 33488 90520326
Knee arthroplasty 26.46 9.41 18 74615 83164 90470650
Hip arthroplasty 26.31 9.41 15 74618 76193 90477621
Wheezing 26.18 9.41 104 74529 237976 90315838
Myelosuppression 26.17 9.41 6 74627 53585 90500229
Medical device site cellulitis 26.09 9.41 9 74624 217 90553597
Retinal vasculitis 25.82 9.41 16 74617 1525 90552289
XIIth nerve injury 25.74 9.41 5 74628 8 90553806
Trigeminal palsy 25.56 9.41 7 74626 75 90553739
Body tinea 25.53 9.41 18 74615 2130 90551684
Infusion site warmth 25.31 9.41 18 74615 2160 90551654
Therapy partial responder 25.25 9.41 56 74577 21987 90531827
Eyelid ptosis 25.19 9.41 34 74599 8972 90544842
Night sweats 25.17 9.41 42 74591 128724 90425090
Skin infection 24.68 9.41 49 74584 17815 90535999
Ventricular hypokinesia 24.60 9.41 26 74607 5315 90548499
Dry mouth 24.56 9.41 74 74559 183985 90369829
Epidural analgesia 24.46 9.41 8 74625 163 90553651
Otitis media 24.28 9.41 27 74606 5843 90547971
Procedure aborted 24.23 9.41 8 74625 168 90553646
Foetal heart rate abnormal 24.17 9.41 13 74620 949 90552865
Gastroenteritis viral 24.07 9.41 67 74566 30288 90523526
Bone erosion 23.86 9.41 7 74626 53014 90500800
Post procedural complication 23.67 9.41 50 74583 18992 90534822
Necrotising fasciitis 23.64 9.41 22 74611 3858 90549956
Colitis ulcerative 23.62 9.41 10 74623 60256 90493558
Punctate keratitis 23.54 9.41 12 74621 784 90553030
Infusion site discomfort 23.42 9.41 16 74617 1800 90552014
Product use in unapproved indication 23.40 9.41 398 74235 335838 90217976
Upper airway obstruction 23.31 9.41 13 74620 1019 90552795
Viral infection 23.19 9.41 81 74552 41333 90512481
Nystagmus 22.88 9.41 29 74604 7198 90546616
Circulatory collapse 22.82 9.41 58 74575 24846 90528968
Medical device site abscess 22.81 9.41 8 74625 203 90553611
Onychomadesis 22.76 9.41 5 74628 45993 90507821
Meningitis aseptic 22.76 9.41 28 74605 6745 90547069
Neuromuscular block prolonged 22.76 9.41 11 74622 641 90553173
Nerve block 22.60 9.41 12 74621 853 90552961
Nephrolithiasis 22.48 9.41 90 74543 48995 90504819
Mastoiditis 22.22 9.41 15 74618 1655 90552159
Poor venous access 21.68 9.41 49 74584 19478 90534336
Paralysis 21.60 9.41 36 74597 11442 90542372
Vitamin D increased 21.60 9.41 12 74621 934 90552880
Foetal exposure during delivery 21.54 9.41 9 74624 371 90553443
Nerve root injury 21.36 9.41 6 74627 71 90553743
Tinnitus 21.34 9.41 81 74552 43021 90510793
Drug-induced liver injury 21.07 9.41 26 74607 90292 90463522
Hepatic cirrhosis 21.06 9.41 13 74620 63240 90490574
Atonic urinary bladder 21.03 9.41 7 74626 151 90553663
Monoplegia 20.80 9.41 20 74613 3654 90550160
Psoriasis 20.73 9.41 58 74575 147696 90406118
Airway peak pressure increased 20.72 9.41 9 74624 409 90553405
Arthritis bacterial 20.66 9.41 28 74605 7417 90546397
Product distribution issue 20.66 9.41 20 74613 3685 90550129
Hyperthermia malignant 20.55 9.41 13 74620 1285 90552529
Spinal anaesthesia 20.44 9.41 6 74627 84 90553730
Haemorrhoids 20.25 9.41 58 74575 26644 90527170
Tremor 20.25 9.41 204 74429 152969 90400845
Drug interaction 20.24 9.41 330 74303 276123 90277691
Lupus vulgaris 20.18 9.41 6 74627 45053 90508761
Red blood cell sedimentation rate increased 20.09 9.41 23 74610 82572 90471242
Infusion site discolouration 20.02 9.41 12 74621 1077 90552737
Frequent bowel movements 19.95 9.41 11 74622 56924 90496890
Visual acuity reduced 19.89 9.41 53 74580 23357 90530457
Adverse event 19.69 9.41 42 74591 117376 90436438
Procedural complication 19.27 9.41 24 74609 5854 90547960
Vocal cord dysfunction 19.26 9.41 11 74622 903 90552911
Vasoplegia syndrome 19.20 9.41 17 74616 2797 90551017
Tenderness 19.07 9.41 57 74576 26811 90527003
Cardio-respiratory arrest 18.74 9.41 102 74531 63038 90490776
Loss of personal independence in daily activities 18.67 9.41 54 74579 136051 90417763
Vascular stenosis 18.58 9.41 9 74624 527 90553287
Blood pressure decreased 18.34 9.41 115 74518 74780 90479034
Nail bed tenderness 18.28 9.41 8 74625 370 90553444
Pulmonary oedema 18.23 9.41 100 74533 61980 90491834
Underdose 18.12 9.41 11 74622 54006 90499808
Retinal artery occlusion 18.10 9.41 15 74618 2256 90551558
Influenza like illness 18.05 9.41 121 74512 80490 90473324
Heliotrope rash 18.03 9.41 7 74626 238 90553576
Peripheral swelling 17.97 9.41 236 74397 412870 90140944
Normal newborn 17.97 9.41 51 74582 23311 90530503
Ventricular extrasystoles 17.89 9.41 36 74597 13214 90540600
Transferrin decreased 17.89 9.41 8 74625 390 90553424
Infection susceptibility increased 17.88 9.41 19 74614 3907 90549907
Electrocardiogram ST segment elevation 17.53 9.41 19 74614 3997 90549817
Inhibitory drug interaction 17.50 9.41 17 74616 3146 90550668
Cellulitis 17.48 9.41 132 74501 91205 90462609
Cystitis 17.32 9.41 104 74529 66614 90487200
Left ventricle outflow tract obstruction 17.26 9.41 8 74625 424 90553390
Inadequate analgesia 17.22 9.41 17 74616 3207 90550607
Haemodynamic instability 17.19 9.41 33 74600 11706 90542108
Anaphylactoid shock 17.15 9.41 8 74625 430 90553384
Wrong product administered 17.12 9.41 26 74607 7639 90546175
Mydriasis 17.04 9.41 38 74595 14974 90538840
Autoimmune disorder 16.96 9.41 23 74610 76721 90477093
Bacterial infection 16.89 9.41 50 74583 23394 90530420
Eye infarction 16.84 9.41 5 74628 73 90553741
Gastrointestinal disorder 16.80 9.41 133 74500 256554 90297260
Intercepted medication error 16.79 9.41 10 74623 887 90552927
Iron binding capacity total decreased 16.68 9.41 8 74625 458 90553356
Spinal synovial cyst 16.65 9.41 5 74628 76 90553738
Apgar score low 16.47 9.41 11 74622 1192 90552622
Retinal detachment 16.47 9.41 24 74609 6798 90547016
Sensory loss 16.46 9.41 42 74591 18033 90535781
Nausea 16.27 9.41 1091 73542 1109225 89444589
Poikiloderma 16.26 9.41 7 74626 311 90553503
Administration site extravasation 16.25 9.41 11 74622 1219 90552595
Blood pressure abnormal 16.21 9.41 44 74589 19601 90534213
Cough 16.18 9.41 408 74225 368554 90185260
Brain stem syndrome 16.03 9.41 9 74624 715 90553099
Respiratory distress 15.94 9.41 69 74564 38877 90514937
Anaphylactoid reaction 15.87 9.41 19 74614 4449 90549365
Loss of consciousness 15.85 9.41 181 74452 140057 90413757
Sinusitis bacterial 15.84 9.41 13 74620 1930 90551884
Cancer pain 15.77 9.41 18 74615 4007 90549807
Apnoeic attack 15.75 9.41 7 74626 336 90553478
Anal sphincter atony 15.75 9.41 7 74626 336 90553478
Retinitis 15.69 9.41 6 74627 38452 90515362
Productive cough 15.67 9.41 113 74520 76950 90476864
Allergy to immunoglobulin therapy 15.65 9.41 6 74627 197 90553617
Vaginal abscess 15.54 9.41 8 74625 534 90553280
Skin discolouration 15.53 9.41 75 74558 44240 90509574
Abortion spontaneous 15.52 9.41 13 74620 54043 90499771
Delayed recovery from anaesthesia 15.52 9.41 10 74623 1020 90552794
Tooth infection 15.48 9.41 44 74589 20126 90533688
Limb injury 15.42 9.41 59 74574 31449 90522365
Drug reaction with eosinophilia and systemic symptoms 15.36 9.41 8 74625 42750 90511064
Asthenia 15.32 9.41 329 74304 533422 90020392
Infusion site irritation 15.30 9.41 11 74622 1342 90552472
Eyelid contusion 15.24 9.41 5 74628 103 90553711
Streptococcal infection 15.16 9.41 24 74609 7309 90546505
Electrocardiogram QRS complex prolonged 15.12 9.41 24 74609 7324 90546490
Glucose tolerance impaired 14.97 9.41 25 74608 7960 90545854
Akinesia 14.96 9.41 12 74621 1724 90552090
Infusion site streaking 14.94 9.41 8 74625 579 90553235
Intentional self-injury 14.90 9.41 3 74630 29331 90524483
Therapeutic product effect incomplete 14.86 9.41 96 74537 193800 90360014
Orbital infection 14.84 9.41 5 74628 112 90553702
Infusion site scar 14.70 9.41 8 74625 598 90553216
Thrombocytopenia 14.68 9.41 106 74527 208619 90345195
Quadriparesis 14.67 9.41 14 74619 2535 90551279
Weight increased 14.63 9.41 249 74384 417678 90136136
Peripheral vascular disorder 14.63 9.41 22 74611 6409 90547405
Procedural anxiety 14.63 9.41 9 74624 847 90552967
Nail bed inflammation 14.57 9.41 12 74621 1789 90552025
Body dysmorphic disorder 14.54 9.41 7 74626 404 90553410
Influenza 14.52 9.41 177 74456 139087 90414727
Cyanosis 14.50 9.41 42 74591 19413 90534401
Hepatotoxicity 14.47 9.41 10 74623 45832 90507982
Obstruction 14.47 9.41 17 74616 3904 90549910
Anorectal discomfort 14.39 9.41 15 74618 3019 90550795
C-reactive protein 14.37 9.41 4 74629 31363 90522451
Implant site bruising 14.31 9.41 7 74626 419 90553395
Infusion site oedema 14.28 9.41 10 74623 1171 90552643
Neonatal toxicity 14.19 9.41 4 74629 48 90553766
Administration site erythema 14.13 9.41 9 74624 900 90552914
Incontinence 14.13 9.41 33 74600 13402 90540412
Epilepsy 14.12 9.41 29 74604 82177 90471637
Axillary nerve injury 14.12 9.41 4 74629 49 90553765
Anterior chamber fibrin 14.11 9.41 5 74628 131 90553683
Calcinosis 14.01 9.41 14 74619 2681 90551133
Tachypnoea 14 9.41 44 74589 21265 90532549
Product preparation error 14.00 9.41 28 74605 10233 90543581
Gastric mucosa erythema 13.88 9.41 7 74626 447 90553367
Vascular resistance systemic decreased 13.86 9.41 5 74628 138 90553676
Neuralgia 13.82 9.41 57 74576 31443 90522371
Cholestasis of pregnancy 13.80 9.41 11 74622 1566 90552248
Vision blurred 13.67 9.41 145 74488 110148 90443666
Back injury 13.65 9.41 11 74622 46611 90507203
Conjunctival oedema 13.61 9.41 9 74624 960 90552854
Retinal haemorrhage 13.51 9.41 20 74613 5744 90548070
Memory impairment 13.47 9.41 101 74532 197143 90356671
Labelled drug-drug interaction medication error 13.40 9.41 34 74599 14548 90539266
Orthostatic hypotension 13.37 9.41 9 74624 41818 90511996
Sinus disorder 13.32 9.41 60 74573 34387 90519427
Spinal stroke 13.31 9.41 4 74629 61 90553753
Sepsis 13.28 9.41 215 74418 179599 90374215
Eclampsia 13.27 9.41 7 74626 491 90553323
Acute respiratory failure 13.19 9.41 70 74563 42848 90510966
Metapneumovirus infection 13.18 9.41 10 74623 1325 90552489
Pneumonia mycoplasmal 13.17 9.41 9 74624 1013 90552801
Oropharyngeal pain 13.16 9.41 149 74484 115038 90438776
Allergy to metals 13.03 9.41 9 74624 1031 90552783
Lower limb fracture 12.97 9.41 32 74601 84981 90468833
Arthritis fungal 12.96 9.41 4 74629 67 90553747
Somnolence 12.93 9.41 243 74390 208841 90344973
Macular oedema 12.93 9.41 18 74615 4891 90548923
Agitation 12.85 9.41 97 74536 67001 90486813
Drug level increased 12.79 9.41 51 74582 27711 90526103
Rash 12.78 9.41 531 74102 795569 89758245
Genital ulceration 12.77 9.41 9 74624 1064 90552750
Poor quality sleep 12.72 9.41 47 74586 24646 90529168
Intraocular pressure fluctuation 12.64 9.41 4 74629 73 90553741
Autonomic neuropathy 12.59 9.41 10 74623 1417 90552397
Haemangioma congenital 12.55 9.41 7 74626 549 90553265
Trigemino-cardiac reflex 12.54 9.41 4 74629 75 90553739
Post procedural infection 12.53 9.41 28 74605 11046 90542768
Spinal cord injury 12.51 9.41 9 74624 1100 90552714
Lethargy 12.50 9.41 92 74541 63047 90490767
Phrenic nerve paralysis 12.50 9.41 6 74627 344 90553470
Coeliac disease 12.48 9.41 11 74622 44599 90509215
Fear-related avoidance of activities 12.45 9.41 5 74628 186 90553628
Tryptase increased 12.42 9.41 7 74626 560 90553254
Implant site swelling 12.36 9.41 7 74626 565 90553249
Quadriplegia 12.36 9.41 12 74621 2219 90551595
Papule 12.34 9.41 23 74610 7979 90545835
Spinal cord oedema 12.33 9.41 5 74628 191 90553623
Diplegia 12.30 9.41 10 74623 1465 90552349
Injection site atrophy 12.24 9.41 8 74625 836 90552978
Nasal mucosal disorder 12.23 9.41 11 74622 1846 90551968
Renal failure 12.17 9.41 163 74470 130844 90422970
Pharyngitis streptococcal 12.01 9.41 30 74603 12712 90541102
Cardiotoxicity 12.01 9.41 28 74605 11361 90542453
Product contamination 11.98 9.41 9 74624 1175 90552639
Proctalgia 11.95 9.41 23 74610 8175 90545639
Accelerated idioventricular rhythm 11.94 9.41 4 74629 88 90553726
Spinal cord ischaemia 11.86 9.41 4 74629 90 90553724
Heparin-induced thrombocytopenia 11.84 9.41 18 74615 5294 90548520
Repetitive strain injury 11.84 9.41 5 74628 212 90553602
Mean arterial pressure decreased 11.81 9.41 5 74628 213 90553601
Economic problem 11.73 9.41 14 74619 3267 90550547
Immunodeficiency 11.69 9.41 11 74622 43223 90510591
Retinal cyst 11.58 9.41 4 74629 97 90553717
Multiple organ dysfunction syndrome 11.56 9.41 96 74537 68240 90485574
Pancreatitis acute 11.55 9.41 6 74627 32109 90521705
Hordeolum 11.54 9.41 17 74616 4861 90548953
Liver function test abnormal 11.48 9.41 15 74618 50830 90502984
Dyspepsia 11.47 9.41 106 74527 198054 90355760
Overdose 11.43 9.41 188 74445 157521 90396293
Application site alopecia 11.42 9.41 3 74630 27 90553787
Infusion related hypersensitivity reaction 11.41 9.41 7 74626 655 90553159
Concussion 11.40 9.41 27 74606 11064 90542750
Meningitis 11.40 9.41 23 74610 8458 90545356
Nerve injury 11.38 9.41 27 74606 11079 90542735
Product administration interrupted 11.35 9.41 29 74604 12463 90541351
Central pain syndrome 11.34 9.41 7 74626 663 90553151
Haemorrhagic vasculitis 11.28 9.41 4 74629 105 90553709
Spinal osteoarthritis 11.20 9.41 38 74595 19110 90534704
White blood cell disorder 11.19 9.41 13 74620 2951 90550863
Hallucination, tactile 11.18 9.41 6 74627 436 90553378
Corneal abrasion 11.14 9.41 9 74624 1307 90552507
Vasospasm 11.09 9.41 8 74625 981 90552833
Eye movement disorder 11.08 9.41 19 74614 6179 90547635
Anorgasmia 11.05 9.41 7 74626 693 90553121
Suicide attempt 11.02 9.41 29 74604 75370 90478444
Pupil fixed 10.96 9.41 11 74622 2117 90551697
Cerebral congestion 10.94 9.41 4 74629 115 90553699
Coccygectomy 10.88 9.41 3 74630 33 90553781
Sympathectomy 10.88 9.41 3 74630 33 90553781
Haematocrit increased 10.79 9.41 13 74620 3065 90550749
Erythema 10.79 9.41 256 74377 228990 90324824
Body temperature abnormal 10.77 9.41 12 74621 2603 90551211
Onychomycosis 10.72 9.41 9 74624 37367 90516447
Liver function test increased 10.69 9.41 35 74598 84820 90468994
Renal cyst 10.68 9.41 29 74604 12921 90540893
Inability to afford medication 10.63 9.41 14 74619 3608 90550206
Device infusion issue 10.59 9.41 12 74621 2650 90551164
Rotator cuff syndrome 10.58 9.41 33 74600 15886 90537928
Speech disorder 10.55 9.41 69 74564 45516 90508298
Incision site swelling 10.55 9.41 5 74628 279 90553535
Product contamination microbial 10.51 9.41 5 74628 281 90553533
Ischaemia 10.49 9.41 17 74616 5278 90548536
Leukopenia 10.43 9.41 45 74588 100665 90453149
Incision site rash 10.42 9.41 3 74630 39 90553775
Cataract nuclear 10.37 9.41 8 74625 1086 90552728
Injection site abscess 10.35 9.41 9 74624 1445 90552369
Taste disorder 10.33 9.41 22 74611 61524 90492290
Chemical burn 10.32 9.41 6 74627 509 90553305
Impaired quality of life 10.25 9.41 42 74591 23102 90530712
Immune thrombocytopenia 10.16 9.41 29 74604 13297 90540517
Allergic cough 10.16 9.41 8 74625 1120 90552694
Neurogenic shock 10.10 9.41 6 74627 530 90553284
Myelitis transverse 10.01 9.41 9 74624 1511 90552303
Muscle tightness 10.01 9.41 29 74604 13410 90540404
Tooth abscess 9.98 9.41 33 74600 16380 90537434
Fanconi syndrome 9.93 9.41 10 74623 1933 90551881
Retrograde amnesia 9.92 9.41 6 74627 548 90553266
Depression 9.91 9.41 181 74452 300420 90253394
Arthritis 9.90 9.41 89 74544 167226 90386588
Macular degeneration 9.87 9.41 10 74623 37960 90515854
Anaesthetic complication cardiac 9.85 9.41 3 74630 48 90553766
Infusion site induration 9.81 9.41 9 74624 1550 90552264
Tooth disorder 9.75 9.41 51 74582 31039 90522775
Clostridium difficile infection 9.73 9.41 57 74576 36188 90517626
Osteomyelitis 9.66 9.41 47 74586 27799 90526015
Laryngeal oedema 9.66 9.41 19 74614 6862 90546952
Miosis 9.65 9.41 23 74610 9461 90544353
Walking aid user 9.64 9.41 9 74624 35497 90518317
Femoral nerve injury 9.63 9.41 3 74630 52 90553762
Spinal operation 9.60 9.41 24 74609 10172 90543642
Administration site reaction 9.56 9.41 5 74628 345 90553469
Myocardial ischaemia 9.52 9.41 29 74604 13785 90540029
Orbital oedema 9.50 9.41 5 74628 349 90553465
Sciatica 9.49 9.41 47 74586 101335 90452479
Steroid diabetes 9.49 9.41 11 74622 2491 90551323
Gastrointestinal infection 9.45 9.41 25 74608 10965 90542849

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Local anaesthetic systemic toxicity 537.20 11.05 164 42770 2136 42576265
Anaphylactic shock 246.44 11.05 198 42736 23319 42555082
Anaphylactic reaction 219.31 11.05 242 42692 42501 42535900
Methaemoglobinaemia 207.63 11.05 106 42828 5668 42572733
Inspiratory capacity decreased 179.48 11.05 78 42856 2889 42575512
Cardiac arrest 149.53 11.05 336 42598 108984 42469417
Anaesthetic complication 127.91 11.05 50 42884 1407 42576994
Toxicity to various agents 115.06 11.05 496 42438 228640 42349761
Toxic anterior segment syndrome 108.33 11.05 44 42890 1372 42577029
Hypotension 107.38 11.05 528 42406 257103 42321298
Ventricular tachycardia 99.86 11.05 137 42797 30023 42548378
Drug ineffective 94.08 11.05 1007 41927 629190 41949211
Injury 90.43 11.05 112 42822 22204 42556197
Ventricular fibrillation 88.15 11.05 129 42805 29994 42548407
Fear 83.61 11.05 77 42857 10888 42567513
Bradycardia 83.30 11.05 231 42703 85253 42493148
Generalised tonic-clonic seizure 80.15 11.05 115 42819 26264 42552137
Emotional distress 72.11 11.05 85 42849 16008 42562393
Anhedonia 70.95 11.05 60 42874 7580 42570821
Renal injury 70.78 11.05 74 42860 12206 42566195
Sinusitis 65.27 11.05 146 42788 47146 42531255
Unresponsive to stimuli 63.86 11.05 114 42820 31289 42547112
Electrocardiogram ST segment elevation 60.05 11.05 49 42885 5890 42572511
Drug ineffective for unapproved indication 53.35 11.05 133 42801 46030 42532371
Tachycardia 51.47 11.05 220 42714 100867 42477534
Overdose 51.23 11.05 226 42708 105038 42473363
Infusion site extravasation 50.80 11.05 43 42891 5438 42572963
Stress 47.58 11.05 124 42810 44088 42534313
Anal inflammation 47.45 11.05 29 42905 2200 42576201
Incorrect route of product administration 46.57 11.05 86 42848 24219 42554182
Infusion site pain 45.29 11.05 40 42894 5355 42573046
Hyperthermia malignant 42.78 11.05 29 42905 2629 42575772
Adulterated product 42.65 11.05 19 42915 747 42577654
Cardiogenic shock 42.57 11.05 104 42830 35536 42542865
Insurance issue 41.70 11.05 34 42900 4082 42574319
Pain 41.31 11.05 402 42532 244446 42333955
Accident 40.76 11.05 41 42893 6462 42571939
SARS-CoV-2 test negative 40.12 11.05 24 42910 1751 42576650
Interstitial lung disease 39.16 11.05 15 42919 78447 42499954
Unevaluable event 38.79 11.05 98 42836 34190 42544211
Trigemino-cardiac reflex 37.10 11.05 14 42920 357 42578044
Electrocardiogram QRS complex prolonged 37.02 11.05 37 42897 5786 42572615
Infusion site erythema 36.86 11.05 30 42904 3592 42574809
Ear infection 36.24 11.05 54 42880 12750 42565651
Status epilepticus 36.19 11.05 60 42874 15518 42562883
Spinal cord infarction 35.42 11.05 16 42918 650 42577751
Sinus tachycardia 34.56 11.05 69 42865 20584 42557817
Diarrhoea 34.01 11.05 299 42635 460550 42117851
Hypoxia 33.30 11.05 149 42785 69637 42508764
Haemodynamic instability 32.77 11.05 51 42883 12506 42565895
Cauda equina syndrome 32.37 11.05 17 42917 963 42577438
Neurotoxicity 31.48 11.05 72 42862 23579 42554822
Acute kidney injury 31.38 11.05 229 42705 367108 42211293
Proctalgia 31.00 11.05 37 42897 7056 42571345
Anaesthetic complication neurological 30.85 11.05 15 42919 721 42577680
Mydriasis 30.78 11.05 41 42893 8729 42569672
Bronchospasm 30.43 11.05 50 42884 12835 42565566
Oculocardiac reflex 29.55 11.05 9 42925 116 42578285
Respiratory tract infection bacterial 28.76 11.05 20 42914 1889 42576512
Tracheitis 28.68 11.05 16 42918 1023 42577378
Seizure 28.21 11.05 213 42721 120348 42458053
Respiratory depression 28 11.05 60 42874 18808 42559593
Respiratory tract infection 27.47 11.05 73 42861 26249 42552152
Blood phosphorus increased 27.44 11.05 47 42887 12478 42565923
Accidental overdose 27.01 11.05 76 42858 28254 42550147
Negative pressure pulmonary oedema 26.99 11.05 13 42921 612 42577789
Infusion site swelling 26.82 11.05 24 42910 3268 42575133
Brain oedema 26.66 11.05 54 42880 16273 42562128
Kounis syndrome 26.35 11.05 24 42910 3344 42575057
Hyperphosphataemia 26.16 11.05 47 42887 12957 42565444
Apnoea 25.14 11.05 35 42899 7768 42570633
Circulatory collapse 25.12 11.05 66 42868 23570 42554831
Appendicolith 25.01 11.05 47 42887 13409 42564992
Vasoplegia syndrome 24.96 11.05 21 42913 2634 42575767
Decreased appetite 24.89 11.05 105 42829 193032 42385369
Disease progression 24.67 11.05 69 42865 143587 42434814
Weight decreased 24.43 11.05 117 42817 207831 42370570
Type I hypersensitivity 24.31 11.05 19 42915 2147 42576254
Loss of consciousness 23.80 11.05 167 42767 92187 42486214
Neuralgia 23.66 11.05 68 42866 25579 42552822
Product adhesion issue 23.39 11.05 17 42917 1722 42576679
Brain stem syndrome 23.10 11.05 12 42922 665 42577736
Paraesthesia oral 22.68 11.05 27 42907 5136 42573265
Drug therapy 22.66 11.05 30 42904 6350 42572051
Diabetes insipidus 22.52 11.05 23 42911 3690 42574711
Myasthenia gravis 22.45 11.05 50 42884 16087 42562314
Respiratory tract infection viral 22.32 11.05 22 42912 3384 42575017
Analgesic therapy 22.13 11.05 30 42904 6494 42571907
Retinal artery occlusion 21.82 11.05 18 42916 2197 42576204
Tubulointerstitial nephritis 21.71 11.05 3 42931 31545 42546856
Psoriasis 21.55 11.05 11 42923 48593 42529808
Postoperative delirium 21.52 11.05 11 42923 589 42577812
Myelosuppression 21.44 11.05 7 42927 40454 42537947
Intracranial hypotension 21.37 11.05 10 42924 441 42577960
Sleep disorder therapy 20.85 11.05 30 42904 6864 42571537
Endophthalmitis 20.83 11.05 24 42910 4409 42573992
Corneal oedema 20.52 11.05 15 42919 1533 42576868
Neuromuscular blockade 20.49 11.05 9 42925 342 42578059
Chemical burn 20.44 11.05 9 42925 344 42578057
Lagophthalmos 20.43 11.05 7 42927 134 42578267
Embolia cutis medicamentosa 20.41 11.05 9 42925 345 42578056
Ventricular extrasystoles 20.35 11.05 43 42891 13347 42565054
Cytomegalovirus infection 20.17 11.05 4 42930 32302 42546099
Seizure like phenomena 20.15 11.05 13 42921 1084 42577317
Anxiety 20.10 11.05 195 42739 118365 42460036
Leukopenia 19.62 11.05 28 42906 74718 42503683
Aqueous fibrin 19.58 11.05 6 42928 79 42578322
Myoclonus 19.53 11.05 49 42885 17016 42561385
Respiratory arrest 19.47 11.05 68 42866 28356 42550045
Mental status changes 19.39 11.05 89 42845 42026 42536375
Behaviour disorder 18.90 11.05 29 42905 7025 42571376
Agranulocytosis 18.68 11.05 4 42930 30608 42547793
Iron deficiency 18.56 11.05 37 42897 11024 42567377
Febrile neutropenia 18.51 11.05 276 42658 185427 42392974
Reperfusion arrhythmia 18.45 11.05 6 42928 97 42578304
Macular ischaemia 18.39 11.05 7 42927 183 42578218
Rheumatoid arthritis 18.24 11.05 10 42924 42430 42535971
Multiple organ dysfunction syndrome 18.15 11.05 163 42771 96872 42481529
Thyrotoxic crisis 18.14 11.05 11 42923 823 42577578
Spinal meningeal cyst 18.12 11.05 6 42928 103 42578298
Administration site pain 17.91 11.05 9 42925 465 42577936
Hypophosphataemia 17.86 11.05 54 42880 20891 42557510
Body temperature increased 17.84 11.05 53 42881 20305 42558096
Tryptase increased 17.78 11.05 8 42926 322 42578079
Cardiotoxicity 17.73 11.05 29 42905 7416 42570985
Post procedural complication 17.50 11.05 39 42895 12551 42565850
Myocardial infarction 17.50 11.05 65 42869 123944 42454457
Wrong product administered 17.25 11.05 26 42908 6200 42572201
Laryngospasm 17.21 11.05 15 42919 1973 42576428
Prostate cancer 17.13 11.05 12 42922 44631 42533770
Blindness 16.91 11.05 48 42886 17930 42560471
Suicide attempt 16.90 11.05 13 42921 46087 42532314
Melaena 16.84 11.05 9 42925 38737 42539664
Infusion site bruising 16.80 11.05 11 42923 941 42577460
Hyperaesthesia 16.70 11.05 25 42909 5927 42572474
Appendicitis 16.51 11.05 52 42882 20561 42557840
Enterobacter pneumonia 16.48 11.05 9 42925 552 42577849
Swelling 16.40 11.05 103 42831 54782 42523619
Hypoxic-ischaemic encephalopathy 16.26 11.05 23 42911 5179 42573222
Haematochezia 16.24 11.05 21 42913 58415 42519986
White blood cell count decreased 16.15 11.05 57 42877 110339 42468062
General physical health deterioration 16.10 11.05 88 42846 151158 42427243
Catecholamine crisis 16.04 11.05 5 42929 70 42578331
Torsade de pointes 15.95 11.05 30 42904 8564 42569837
Bacteroides infection 15.65 11.05 16 42918 2571 42575830
Anal sphincter atony 15.58 11.05 6 42928 162 42578239
Vitreous disorder 15.51 11.05 6 42928 164 42578237
Ventricular asystole 15.30 11.05 7 42927 293 42578108
Haemoglobin decreased 15.27 11.05 75 42859 132396 42446005
Vitreous floaters 15.19 11.05 20 42914 4210 42574191
Hypoaesthesia oral 14.77 11.05 21 42913 4752 42573649
Delayed recovery from anaesthesia 14.76 11.05 11 42923 1158 42577243
Abdominal discomfort 14.57 11.05 34 42900 75221 42503180
Electrocardiogram T wave amplitude increased 14.29 11.05 5 42929 102 42578299
Pancreatitis acute 14.29 11.05 8 42926 33556 42544845
Phaeochromocytoma crisis 14.20 11.05 5 42929 104 42578297
Pulse absent 14.20 11.05 24 42910 6303 42572098
Blood uric acid increased 14.13 11.05 41 42893 15506 42562895
Cardiac failure congestive 14.04 11.05 42 42892 85560 42492841
Therapy non-responder 14.04 11.05 97 42837 53262 42525139
Pneumocystis jirovecii pneumonia 13.98 11.05 4 42930 25177 42553224
Procedural hypotension 13.93 11.05 10 42924 993 42577408
Asthma 13.87 11.05 26 42908 62288 42516113
Postictal state 13.78 11.05 10 42924 1010 42577391
Drug-induced liver injury 13.77 11.05 11 42923 38262 42540139
Myokymia 13.65 11.05 5 42929 117 42578284
Haemorrhoids 13.58 11.05 43 42891 17054 42561347
Diabetic ketoacidosis 13.49 11.05 3 42931 22364 42556037
Encephalomalacia 13.43 11.05 10 42924 1051 42577350
Treatment noncompliance 13.34 11.05 11 42923 37661 42540740
Oesophageal obstruction 13.24 11.05 8 42926 594 42577807
Chills 13.23 11.05 149 42785 93917 42484484
Myalgia 13.14 11.05 51 42883 96029 42482372
Procedural pain 13.07 11.05 22 42912 5757 42572644
Ventricular arrhythmia 13.02 11.05 23 42911 6256 42572145
Total lung capacity decreased 13.01 11.05 17 42917 3553 42574848
Blindness transient 12.94 11.05 15 42919 2774 42575627
Asthenia 12.92 11.05 202 42732 280591 42297810
Hepatic function abnormal 12.87 11.05 20 42914 51547 42526854
Brain hypoxia 12.83 11.05 8 42926 629 42577772
Malignant neoplasm progression 12.70 11.05 61 42873 108339 42470062
Frequent bowel movements 12.65 11.05 3 42931 21404 42556997
Mean arterial pressure increased 12.58 11.05 4 42930 60 42578341
Infusion site pruritus 12.54 11.05 10 42924 1163 42577238
Retinal vasculitis 12.53 11.05 8 42926 655 42577746
Weight increased 12.52 11.05 61 42873 107922 42470479
Illness 12.47 11.05 54 42880 24876 42553525
Hepatitis 12.37 11.05 6 42928 27294 42551107
Kidney congestion 12.29 11.05 7 42927 466 42577935
Shock 12.28 11.05 60 42874 29061 42549340
Ophthalmoplegia 12.22 11.05 13 42921 2187 42576214
Aortic stenosis 12.05 11.05 27 42907 8718 42569683
Post herpetic neuralgia 12.01 11.05 10 42924 1236 42577165
Upper respiratory tract infection 11.89 11.05 78 42856 42095 42536306
Pulmonary fibrosis 11.89 11.05 6 42928 26675 42551726
Miosis 11.78 11.05 35 42899 13411 42564990
Macroglossia 11.77 11.05 7 42927 505 42577896
Oxygen saturation decreased 11.75 11.05 108 42826 64579 42513822
Accidental death 11.73 11.05 15 42919 3068 42575333
Product contamination microbial 11.64 11.05 8 42926 742 42577659
Respiratory acidosis 11.62 11.05 22 42912 6309 42572092
Lung opacity 11.62 11.05 21 42913 5816 42572585
Pulseless electrical activity 11.58 11.05 26 42908 8411 42569990
Myotonic dystrophy 11.56 11.05 5 42929 183 42578218
Open globe injury 11.56 11.05 4 42930 79 42578322
Prostate infection 11.55 11.05 10 42924 1304 42577097
Hypopyon 11.49 11.05 7 42927 528 42577873
Completed suicide 11.47 11.05 54 42880 96411 42481990
Anaemia 11.47 11.05 206 42728 280072 42298329
Coronary artery disease 11.45 11.05 23 42911 53697 42524704
Blood pressure systolic increased 11.43 11.05 7 42927 27961 42550440
Cerebral venous thrombosis 11.40 11.05 9 42925 1032 42577369
Anaesthetic complication pulmonary 11.37 11.05 4 42930 83 42578318
Disability 11.37 11.05 21 42913 5912 42572489
Atrioventricular block complete 11.34 11.05 31 42903 11333 42567068
Brugada syndrome 11.31 11.05 9 42925 1044 42577357
Inadequate analgesia 11.30 11.05 15 42919 3182 42575219
Hypertonia 11.26 11.05 19 42915 4982 42573419
Thrombocytopenia 11.25 11.05 130 42804 190149 42388252

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Local anaesthetic systemic toxicity 1388.37 10.01 403 95390 5134 110488372
Anaphylactic reaction 608.66 10.01 615 95178 113685 110379821
Anaphylactic shock 513.59 10.01 396 95397 51150 110442356
Cardiac arrest 432.76 10.01 680 95113 196073 110297433
Toxic anterior segment syndrome 329.75 10.01 121 95672 3333 110490173
Methaemoglobinaemia 310.64 10.01 154 95639 9014 110484492
Maternal exposure during delivery 296.94 10.01 113 95680 3452 110490054
Hypotension 260.00 10.01 1018 94775 522831 109970675
Anaesthetic complication 246.33 10.01 99 95694 3507 110489999
Toxicity to various agents 211.47 10.01 900 94893 479655 110013851
Generalised tonic-clonic seizure 201.92 10.01 243 95550 54437 110439069
Synovitis 192.90 10.01 11 95782 274081 110219425
Bradycardia 187.06 10.01 415 95378 155102 110338404
Kounis syndrome 175.82 10.01 91 95702 5834 110487672
Inspiratory capacity decreased 162.72 10.01 67 95726 2528 110490978
Hand deformity 159.36 10.01 7 95786 218499 110275007
Systemic lupus erythematosus 147.83 10.01 22 95771 254316 110239190
Ventricular fibrillation 146.67 10.01 180 95613 41133 110452373
Ventricular tachycardia 146.34 10.01 198 95595 49811 110443695
Hepatic enzyme increased 140.75 10.01 51 95742 320841 110172665
Fear 136.66 10.01 132 95661 23061 110470445
Pemphigus 135.81 10.01 14 95779 214556 110278950
Pericarditis 134.38 10.01 16 95777 219098 110274408
Joint swelling 132.87 10.01 113 95680 442732 110050774
Anti-cyclic citrullinated peptide antibody positive 132.14 10.01 6 95787 181978 110311528
Duodenal ulcer perforation 128.57 10.01 6 95787 177694 110315812
Unresponsive to stimuli 125.76 10.01 210 95583 63580 110429926
Glossodynia 124.95 10.01 21 95772 221983 110271523
Seizure 119.41 10.01 442 95351 220743 110272763
Contraindicated product administered 118.51 10.01 34 95759 248233 110245273
Emotional distress 118.41 10.01 169 95624 44678 110448828
Stress cardiomyopathy 114.57 10.01 101 95692 15705 110477801
Renal injury 113.08 10.01 108 95685 18605 110474901
Anaesthetic complication neurological 109.12 10.01 39 95754 994 110492512
Drug ineffective for unapproved indication 105.60 10.01 258 95535 102580 110390926
Arthropathy 105.27 10.01 59 95734 287463 110206043
General physical health deterioration 104.33 10.01 129 95664 425166 110068340
Anhedonia 102.77 10.01 94 95699 15334 110478172
Pulseless electrical activity 101.81 10.01 97 95696 16660 110476846
Folliculitis 100.94 10.01 13 95780 167640 110325866
Type 2 diabetes mellitus 94.92 10.01 19 95774 177213 110316293
Mobility decreased 90.90 10.01 46 95747 237376 110256130
Tachycardia 89.97 10.01 412 95381 226233 110267273
Unevaluable event 88.67 10.01 173 95620 59054 110434452
Rheumatoid factor positive 87.55 10.01 7 95786 131633 110361873
Insurance issue 87.48 10.01 73 95720 10539 110482967
Status epilepticus 86.34 10.01 121 95672 31450 110462056
Psoriatic arthropathy 85.01 10.01 32 95761 196729 110296777
Procedural hypotension 84.63 10.01 42 95751 2463 110491043
Muscle injury 84.57 10.01 11 95782 140796 110352710
Wound 84.53 10.01 49 95744 234388 110259118
Abdominal discomfort 84.05 10.01 132 95661 393726 110099780
Rheumatic fever 82.99 10.01 6 95787 122573 110370933
Liver injury 80.80 10.01 16 95777 150397 110343109
Drug ineffective 79.62 10.01 1797 93996 1518743 108974763
Cardiogenic shock 79.26 10.01 162 95631 57176 110436330
Apnoea 79.17 10.01 77 95716 13562 110479944
Corneal oedema 78.01 10.01 43 95750 3130 110490376
Incorrect route of product administration 75.89 10.01 170 95623 63891 110429615
Bronchospasm 75.52 10.01 111 95682 30128 110463378
Sinus tachycardia 75.35 10.01 137 95656 44356 110449150
Therapeutic product effect decreased 72.41 10.01 63 95730 244253 110249253
Rheumatoid arthritis 72.26 10.01 92 95701 299521 110193985
Pulse absent 71.72 10.01 67 95726 11225 110482281
Facet joint syndrome 70.92 10.01 3 95790 96825 110396681
Mental status changes 70.84 10.01 184 95609 75938 110417568
Impaired healing 69.66 10.01 42 95751 196675 110296831
Product adhesion issue 69.17 10.01 39 95754 2967 110490539
Stress 65.82 10.01 221 95572 105127 110388379
C-reactive protein abnormal 65.21 10.01 16 95777 129679 110363827
Cauda equina syndrome 64.14 10.01 33 95760 2089 110491417
Neurotoxicity 64.05 10.01 124 95669 42083 110451423
Endophthalmitis 62.73 10.01 54 95739 8133 110485373
Irritable bowel syndrome 62.57 10.01 32 95761 164183 110329323
Hyperthermia malignant 62.25 10.01 40 95753 3860 110489646
Infusion site swelling 61.57 10.01 58 95735 9819 110483687
Lagophthalmos 61.50 10.01 22 95771 562 110492944
Alopecia 61.35 10.01 141 95652 364612 110128894
Hypoxia 61.01 10.01 248 95545 129267 110364239
Infusion related reaction 60.42 10.01 152 95641 381010 110112496
Infusion site pain 60.37 10.01 75 95718 17344 110476162
Myelosuppression 60.08 10.01 6 95787 94334 110399172
Lip dry 59.66 10.01 8 95785 100075 110393431
Sleep disorder due to general medical condition, insomnia type 59.41 10.01 10 95783 105633 110387873
Overdose 58.71 10.01 375 95418 233419 110260087
Bursitis 58.03 10.01 20 95773 129898 110363608
Embolia cutis medicamentosa 57.46 10.01 24 95769 939 110492567
Sulphaemoglobinaemia 57.37 10.01 21 95772 574 110492932
Respiratory depression 57.34 10.01 101 95692 31900 110461606
Type I hypersensitivity 56.93 10.01 46 95747 6347 110487159
Infusion site erythema 55.76 10.01 60 95733 11899 110481607
Electrocardiogram ST segment elevation 55.60 10.01 53 95740 9107 110484399
Obesity 55.04 10.01 15 95778 113336 110380170
Hypercholesterolaemia 54.77 10.01 7 95786 90830 110402676
Peripheral venous disease 54.49 10.01 5 95788 84112 110409394
Infusion site bruising 54.34 10.01 36 95757 3658 110489848
Haemodynamic instability 54.27 10.01 82 95711 22806 110470700
Ill-defined disorder 53.45 10.01 35 95758 156818 110336688
Anterior chamber cell 51.99 10.01 24 95769 1197 110492309
Blister 51.58 10.01 73 95720 227303 110266203
Swollen joint count increased 51.54 10.01 6 95787 83655 110409851
Arthralgia 51.53 10.01 430 95363 779202 109714304
Extradural abscess 51.21 10.01 28 95765 2006 110491500
Hypopyon 51.20 10.01 25 95768 1415 110492091
Trigemino-cardiac reflex 50.57 10.01 18 95775 453 110493053
Inflammation 50.13 10.01 56 95737 193182 110300324
Extradural haematoma 49.97 10.01 33 95760 3336 110490170
Electrocardiogram QRS complex prolonged 49.91 10.01 59 95734 12962 110480544
Illness 49.24 10.01 170 95623 82001 110411505
Premature delivery 48.95 10.01 92 95701 30540 110462966
Infusion site pruritus 48.81 10.01 38 95755 4970 110488536
Musculoskeletal stiffness 48.81 10.01 106 95687 279716 110213790
Anal inflammation 48.46 10.01 29 95764 2467 110491039
Infusion site extravasation 48.43 10.01 55 95738 11579 110481927
Dermatitis contact 48.24 10.01 60 95733 13893 110479613
Completed suicide 48.17 10.01 85 95708 242296 110251210
Loss of consciousness 48.13 10.01 313 95480 195993 110297513
Systemic toxicity 47.23 10.01 16 95777 346 110493160
Liver disorder 46.78 10.01 33 95760 142210 110351296
Abdominal pain upper 46.66 10.01 151 95642 348960 110144546
Paraplegia 45.70 10.01 40 95753 6160 110487346
Spinal cord infarction 44.94 10.01 21 95772 1077 110492429
Hypoaesthesia oral 44.77 10.01 64 95729 16938 110476568
Gait inability 44.38 10.01 32 95761 136344 110357162
Circulatory collapse 44.26 10.01 108 95685 42885 110450621
Osteoarthritis 44.09 10.01 56 95737 182567 110310939
Fibromyalgia 43.82 10.01 50 95743 170859 110322647
Retinal artery occlusion 43.07 10.01 33 95760 4216 110489290
Proctalgia 42.76 10.01 55 95738 13167 110480339
Aqueous fibrin 42.44 10.01 13 95780 201 110493305
Vitritis 41.82 10.01 27 95766 2626 110490880
Respiratory tract infection 41.03 10.01 146 95647 71471 110422035
C-reactive protein increased 41.01 10.01 79 95714 217840 110275666
Urinary tract infection 40.69 10.01 447 95346 325835 110167671
Multiple organ dysfunction syndrome 40.35 10.01 247 95546 151463 110342043
Retinal vasculitis 40.28 10.01 24 95769 2025 110491481
COVID-19 39.94 10.01 355 95438 244705 110248801
SARS-CoV-2 test negative 39.18 10.01 24 95769 2129 110491377
Ophthalmoplegia 39.15 10.01 29 95764 3521 110489985
Accidental overdose 39.03 10.01 116 95677 51718 110441788
Pulmonary fibrosis 38.69 10.01 20 95773 102022 110391484
Sinusitis 38.63 10.01 410 95383 296278 110197228
Peripheral nerve injury 38.05 10.01 19 95774 1129 110492377
Adulterated product 37.94 10.01 19 95774 1136 110492370
Vasoplegia syndrome 37.91 10.01 34 95759 5405 110488101
Fear of eating 37.81 10.01 15 95778 513 110492993
Anxiety 37.78 10.01 461 95332 344617 110148889
Interstitial lung disease 37.67 10.01 39 95754 139295 110354211
Seasonal allergy 37.63 10.01 64 95729 19658 110473848
Mydriasis 37.22 10.01 68 95725 22089 110471417
Haemorrhoids 37.13 10.01 90 95703 35582 110457924
Lower respiratory tract infection 36.93 10.01 99 95694 243007 110250499
Hepatitis 36.68 10.01 16 95777 90038 110403468
Respiratory tract infection bacterial 36.65 10.01 24 95769 2392 110491114
Appendicolith 36.57 10.01 53 95740 14202 110479304
Brain oedema 36.24 10.01 82 95711 31016 110462490
Colitis ulcerative 36.15 10.01 11 95782 77352 110416154
Pulmonary oedema 35.56 10.01 177 95616 100482 110393024
Meningitis chemical 35.46 10.01 13 95780 357 110493149
Staphylococcal infection 35.40 10.01 137 95656 69807 110423699
Joint range of motion decreased 35.38 10.01 32 95761 121800 110371706
Post procedural complication 35.29 10.01 74 95719 26584 110466922
Cardiotoxicity 35.18 10.01 57 95736 16824 110476682
Vascular malformation 34.66 10.01 16 95777 798 110492708
Infusion site haemorrhage 34.56 10.01 30 95763 4568 110488938
Wrong product administered 34.52 10.01 45 95748 10915 110482591
Nystagmus 34.11 10.01 46 95747 11531 110481975
Nail disorder 33.66 10.01 5 95788 57930 110435576
Spinal epidural haematoma 33.38 10.01 20 95773 1705 110491801
Neuralgia 33.24 10.01 105 95688 48373 110445133
Paranasal cyst 33.06 10.01 16 95777 888 110492618
Analgesic therapy 33.01 10.01 36 95757 7248 110486258
Drug therapy 32.98 10.01 36 95757 7255 110486251
Postoperative delirium 32.88 10.01 16 95777 899 110492607
Spinal epidural haemorrhage 32.85 10.01 12 95781 326 110493180
Ventricular extrasystoles 32.51 10.01 65 95728 22576 110470930
Deep vein thrombosis postoperative 32.49 10.01 6 95787 59285 110434221
Tryptase increased 32.42 10.01 16 95777 927 110492579
Hyperphosphataemia 32.37 10.01 54 95739 16327 110477179
Sleep disorder therapy 32.26 10.01 36 95757 7435 110486071
Febrile neutropenia 32.03 10.01 417 95376 316350 110177156
Psoriasis 31.69 10.01 45 95748 139948 110353558
Paralysis 31.60 10.01 52 95741 15548 110477958
Grip strength decreased 31.48 10.01 15 95778 80159 110413347
Upper respiratory tract infection 31.33 10.01 208 95585 131120 110362386
Anal sphincter atony 31.29 10.01 13 95780 502 110493004
Delayed recovery from anaesthesia 31.17 10.01 21 95772 2194 110491312
Stridor 31.11 10.01 34 95759 6861 110486645
Adverse event 31.09 10.01 29 95764 108780 110384726
Diarrhoea 30.53 10.01 753 95040 1138752 109354754
Oculocardiac reflex 30.48 10.01 9 95784 122 110493384
Product dose omission issue 30.22 10.01 418 95375 321364 110172142
Accident 29.98 10.01 42 95751 10910 110482596
Corneal epithelium defect 29.95 10.01 15 95778 897 110492609
Drug-induced liver injury 29.83 10.01 36 95757 120031 110373475
Blood phosphorus increased 29.83 10.01 52 95741 16288 110477218
Respiratory arrest 29.34 10.01 114 95679 58185 110435321
Purtscher retinopathy 29.15 10.01 10 95783 225 110493281
Lung disorder 29.13 10.01 71 95722 179976 110313530
Diabetes insipidus 28.95 10.01 32 95761 6538 110486968
Drug intolerance 28.74 10.01 220 95573 406292 110087214
Infusion site urticaria 28.59 10.01 16 95777 1200 110492306
Frequent bowel movements 28.58 10.01 13 95780 71377 110422129
Infusion site mass 28.27 10.01 18 95775 1710 110491796
Neuromuscular block prolonged 28.21 10.01 16 95777 1231 110492275
Incorrect drug administration rate 28.11 10.01 29 95764 5479 110488027
Asthenia 28.02 10.01 424 95369 688575 109804931
Underdose 28.01 10.01 10 95783 63544 110429962
Therapy partial responder 27.96 10.01 83 95710 36978 110456528
Multiple allergies 27.75 10.01 43 95750 12220 110481286
Myasthenia gravis 27.65 10.01 59 95734 21452 110472054
Back pain 27.54 10.01 463 95330 370533 110122973
Prescribed underdose 27.47 10.01 11 95782 65163 110428343
Negative pressure pulmonary oedema 27.47 10.01 13 95780 686 110492820
Arthritis 27.18 10.01 66 95727 167520 110325986
Blepharospasm 27.12 10.01 7 95786 54844 110438662
Epidural haemorrhage 27.04 10.01 11 95782 402 110493104
Coeliac disease 26.85 10.01 3 95790 43184 110450322
Gastrointestinal disorder 26.83 10.01 113 95680 241839 110251667
Lower limb fracture 26.79 10.01 16 95777 75332 110418174
Neuromuscular blockade 26.70 10.01 13 95780 731 110492775
Chemical burn 26.64 10.01 13 95780 735 110492771
Onychomadesis 26.40 10.01 4 95789 45659 110447847
Platelet aggregation inhibition 26.30 10.01 9 95784 201 110493305
Visual acuity reduced 26.15 10.01 74 95719 32099 110461407
Blood pressure decreased 26.08 10.01 180 95613 114911 110378595
Punctate keratitis 26.03 10.01 15 95778 1189 110492317
Tracheitis 25.87 10.01 17 95776 1704 110491802
Cyanosis 25.74 10.01 70 95723 29671 110463835
Bursitis infective 25.71 10.01 16 95777 1460 110492046
Suicide attempt 25.69 10.01 31 95762 103363 110390143
Hypophosphataemia 25.69 10.01 75 95718 33107 110460399
Procedural complication 25.68 10.01 34 95759 8371 110485135
Weight increased 25.65 10.01 236 95557 419408 110074098
XIIth nerve injury 25.49 10.01 5 95788 8 110493498
Medical device site cellulitis 25.46 10.01 9 95784 222 110493284
Condition aggravated 25.36 10.01 466 95327 734370 109759136
Trigeminal palsy 25.21 10.01 7 95786 75 110493431
Upper airway obstruction 25.16 10.01 17 95776 1785 110491721
Pneumocephalus 25.06 10.01 11 95782 487 110493019
Myoclonus 24.99 10.01 74 95719 32924 110460582
Drug hypersensitivity 24.97 10.01 262 95531 453828 110039678
Body tinea 24.96 10.01 18 95775 2097 110491409
Foetal heart rate abnormal 24.84 10.01 12 95781 663 110492843
Inadequate analgesia 24.60 10.01 26 95767 5051 110488455
Brain stem syndrome 24.56 10.01 15 95778 1324 110492182
Hyperaesthesia 24.49 10.01 45 95748 14682 110478824
Decreased appetite 24.39 10.01 279 95514 475567 110017939
Stomatitis 24.28 10.01 136 95657 270106 110223400
Parophthalmia 24.28 10.01 11 95782 525 110492981
Epidural analgesia 23.97 10.01 8 95785 165 110493341
Therapeutic product effect incomplete 23.91 10.01 106 95687 223699 110269807
Wound infection 23.89 10.01 29 95764 96436 110397070
Acute kidney injury 23.82 10.01 397 95396 635033 109858473
Spinal cord compression 23.78 10.01 31 95762 7521 110485985
Wheezing 23.73 10.01 127 95666 255103 110238403
Procedure aborted 23.62 10.01 8 95785 173 110493333
Torsade de pointes 23.50 10.01 57 95736 22543 110470963
Swelling 23.40 10.01 193 95600 350848 110142658
Shock 23.18 10.01 100 95693 53488 110440018
Hepatic cirrhosis 23.15 10.01 15 95778 67611 110425895
Rash 22.63 10.01 540 95253 820424 109673082
Lupus-like syndrome 22.63 10.01 4 95789 40788 110452718
Musculoskeletal pain 22.51 10.01 82 95711 182941 110310565
Otitis media 22.47 10.01 30 95763 7446 110486060
Medical device site abscess 22.45 10.01 8 95785 202 110493304
Miosis 22.39 10.01 55 95738 21928 110471578
Airway peak pressure increased 22.34 10.01 11 95782 634 110492872
Spinal anaesthesia 22.29 10.01 7 95786 118 110493388
Hypersensitivity 22.25 10.01 233 95560 403765 110089741
Drug level increased 22.16 10.01 91 95702 47628 110445878
Respiratory distress 22.16 10.01 118 95675 68756 110424750
Cardio-respiratory arrest 22.16 10.01 174 95619 115662 110377844
Behaviour disorder 22.07 10.01 34 95759 9613 110483893
Mean arterial pressure decreased 22.00 10.01 10 95783 481 110493025
Product contamination microbial 21.99 10.01 13 95780 1081 110492425
Blood cholesterol increased 21.93 10.01 84 95709 184701 110308805
Appendicitis 21.71 10.01 64 95729 28400 110465106
Product preparation error 21.68 10.01 36 95757 10843 110482663
Cytomegalovirus infection 21.66 10.01 10 95783 54434 110439072
Haematochezia 21.62 10.01 42 95751 115482 110378024
Mastoiditis 21.60 10.01 18 95775 2593 110490913
Infusion site discharge 21.50 10.01 16 95777 1957 110491549
Nerve root injury 21.46 10.01 6 95787 66 110493440
Macular ischaemia 21.38 10.01 8 95785 233 110493273
Loss of personal independence in daily activities 21.36 10.01 63 95730 149957 110343549
Eyelid ptosis 21.26 10.01 40 95753 13287 110480219
Diplopia 21.15 10.01 82 95711 41812 110451694
Red blood cell sedimentation rate increased 21.07 10.01 22 95771 78280 110415226
Prescribed overdose 20.98 10.01 27 95766 87554 110405952
Bundle branch block left 20.95 10.01 39 95754 12849 110480657
Night sweats 20.76 10.01 54 95739 133929 110359577
Disease progression 20.75 10.01 125 95668 243909 110249597
Foot deformity 20.74 10.01 8 95785 48472 110445034
Hepatotoxicity 20.46 10.01 15 95778 63385 110430121
Tenderness 20.40 10.01 64 95729 29373 110464133
Atonic urinary bladder 20.34 10.01 7 95786 159 110493347
Chills 20.14 10.01 253 95540 190327 110303179
Tubulointerstitial nephritis 20.05 10.01 11 95782 54273 110439233
Drug reaction with eosinophilia and systemic symptoms 19.99 10.01 25 95768 82070 110411436
Gastroenteritis viral 19.93 10.01 66 95727 31160 110462346
Blindness 19.87 10.01 73 95720 36286 110457220
Pancreatitis acute 19.79 10.01 14 95779 60260 110433246
Hip arthroplasty 19.63 10.01 12 95781 55801 110437705
Intracranial hypotension 19.51 10.01 10 95783 628 110492878
Sinus bradycardia 19.43 10.01 63 95730 29420 110464086
Leukopenia 19.41 10.01 65 95728 148726 110344780
Bacterial infection 19.22 10.01 85 95708 45951 110447555
Peripheral swelling 19.13 10.01 241 95552 403793 110089713
Bronchitis 19.03 10.01 214 95579 156818 110336688
Tremor 18.69 10.01 262 95531 201970 110291536
Iron deficiency 18.58 10.01 46 95747 18430 110475076
Restlessness 18.52 10.01 97 95696 56162 110437344
Seizure like phenomena 18.50 10.01 16 95777 2425 110491081
Vocal cord dysfunction 18.34 10.01 11 95782 939 110492567
Dyspepsia 18.32 10.01 94 95699 190871 110302635
Respiratory tract infection viral 18.31 10.01 24 95769 5854 110487652
Epilepsy 18.26 10.01 37 95756 100172 110393334
Sepsis 18.25 10.01 391 95402 326955 110166551
Intentional self-injury 18.08 10.01 5 95788 37424 110456082
Sensory loss 18.07 10.01 50 95743 21407 110472099
Hepatic function abnormal 18.02 10.01 31 95762 89264 110404242
Quadriplegia 18.01 10.01 20 95773 4107 110489399
Agitation 18.00 10.01 163 95630 112888 110380618
Economic problem 18.00 10.01 20 95773 4111 110489395
Anaphylactoid shock 17.97 10.01 11 95782 975 110492531
Paraesthesia oral 17.90 10.01 67 95726 33604 110459902
Ear infection 17.86 10.01 104 95689 62628 110430878
Respiratory acidosis 17.86 10.01 38 95755 13788 110479718
Nail bed tenderness 17.77 10.01 8 95785 376 110493130
Knee arthroplasty 17.75 10.01 18 95775 64930 110428576
Spinal cord ischaemia 17.71 10.01 7 95786 237 110493269
Anal skin tags 17.70 10.01 9 95784 556 110492950
Thrombocytopenia 17.70 10.01 205 95588 348680 110144826
Laryngospasm 17.64 10.01 21 95772 4647 110488859
Anterior chamber fibrin 17.55 10.01 7 95786 243 110493263
Skin infection 17.54 10.01 51 95742 22458 110471048
Spinal meningeal cyst 17.53 10.01 6 95787 134 110493372
Product use issue 17.47 10.01 179 95614 311516 110181990
Hypoxic-ischaemic encephalopathy 17.26 10.01 29 95764 8818 110484688
Infusion site rash 17.03 10.01 15 95778 2328 110491178
Spinal cord injury 17.03 10.01 13 95780 1652 110491854
Aortic stenosis 16.99 10.01 36 95757 13023 110480483
Depressed level of consciousness 16.93 10.01 160 95633 112118 110381388
Serotonin syndrome 16.80 10.01 98 95695 59055 110434451
Vitamin D increased 16.79 10.01 10 95783 843 110492663
Pneumocystis jirovecii pneumonia 16.77 10.01 8 95785 42727 110450779
Heparin-induced thrombocytopenia 16.64 10.01 33 95760 11391 110482115
Injection site joint infection 16.53 10.01 5 95788 74 110493432
Cholestasis 16.39 10.01 19 95774 64499 110429007
Necrotising fasciitis 16.32 10.01 26 95767 7565 110485941
Orthostatic hypotension 16.31 10.01 20 95773 66229 110427277
Kidney infection 16.24 10.01 54 95739 25545 110467961
Total lung capacity decreased 16.18 10.01 25 95768 7089 110486417
Atrioventricular block complete 16.13 10.01 46 95747 20036 110473470
Anaesthetic complication pulmonary 16.12 10.01 6 95787 172 110493334
Spinal cord oedema 16.10 10.01 8 95785 470 110493036
Airway complication of anaesthesia 16.08 10.01 9 95784 675 110492831
Respiratory failure 16.06 10.01 269 95524 215063 110278443
Bacteroides infection 16.05 10.01 16 95777 2903 110490603
Reperfusion arrhythmia 16.01 10.01 7 95786 307 110493199
Thrombosis 15.96 10.01 154 95639 108508 110384998
Infusion site discomfort 15.90 10.01 13 95780 1824 110491682
Vaginal abscess 15.87 10.01 8 95785 485 110493021
Ventricular hypokinesia 15.87 10.01 32 95761 11182 110482324
Sleep disorder 15.73 10.01 104 95689 198540 110294966
Anal ulcer 15.66 10.01 13 95780 1863 110491643
Product distribution issue 15.52 10.01 19 95774 4327 110489179
Implant site bruising 15.49 10.01 7 95786 332 110493174
Cholestasis of pregnancy 15.47 10.01 11 95782 1254 110492252
Onychomycosis 15.45 10.01 7 95786 38524 110454982
Kidney congestion 15.34 10.01 8 95785 521 110492985
Streptococcal infection 15.32 10.01 31 95762 10859 110482647
Catecholamine crisis 15.32 10.01 5 95788 96 110493410
Insomnia 15.28 10.01 220 95573 360370 110133136
Ventricular tachyarrhythmia 15.28 10.01 8 95785 525 110492981
Monoplegia 15.22 10.01 20 95773 4889 110488617
Left ventricle outflow tract obstruction 15.14 10.01 8 95785 535 110492971
Familial periodic paralysis 15.11 10.01 7 95786 352 110493154
Blood uric acid increased 15.10 10.01 47 95746 21482 110472024
Vascular stenosis 15.00 10.01 9 95784 769 110492737
Application site alopecia 14.93 10.01 4 95789 37 110493469
Retrograde amnesia 14.91 10.01 9 95784 778 110492728
Eyelid contusion 14.90 10.01 5 95788 105 110493401
Nerve block 14.88 10.01 9 95784 780 110492726
Eclampsia 14.87 10.01 7 95786 365 110493141
Nail bed inflammation 14.77 10.01 13 95780 2017 110491489
Oxygen saturation decreased 14.75 10.01 204 95589 156778 110336728
Bone marrow failure 14.74 10.01 17 95776 57831 110435675
Apnoeic attack 14.65 10.01 9 95784 803 110492703
Normal newborn 14.62 10.01 47 95746 21849 110471657
Repetitive strain injury 14.58 10.01 6 95787 226 110493280
Phrenic nerve paralysis 14.56 10.01 8 95785 579 110492927
Vitreous disorder 14.54 10.01 7 95786 384 110493122
Ventricular arrhythmia 14.53 10.01 29 95764 10058 110483448
Infusion site streaking 14.52 10.01 8 95785 582 110492924
Administration site pain 14.45 10.01 9 95784 822 110492684
Enterobacter pneumonia 14.33 10.01 8 95785 597 110492909
Heliotrope rash 14.29 10.01 6 95787 238 110493268
Arthritis bacterial 14.28 10.01 30 95763 10790 110482716
Confusional state 14.09 10.01 304 95489 468376 110025130
Renal failure 14.06 10.01 275 95518 226299 110267207
Ventricular asystole 13.92 10.01 7 95786 422 110493084
Air embolism 13.91 10.01 8 95785 632 110492874
Drug resistance 13.90 10.01 17 95776 56357 110437149
Irregular breathing 13.90 10.01 8 95785 633 110492873
Autoimmune disorder 13.89 10.01 22 95771 65461 110428045
Lung opacity 13.88 10.01 31 95762 11621 110481885
Liver function test abnormal 13.85 10.01 24 95769 68926 110424580
Axillary nerve injury 13.84 10.01 4 95789 50 110493456
Body dysmorphic disorder 13.83 10.01 7 95786 428 110493078
Agranulocytosis 13.83 10.01 20 95773 61740 110431766
Encephalomalacia 13.78 10.01 11 95782 1491 110492015
Infection susceptibility increased 13.76 10.01 18 95775 4380 110489126
Harlequin syndrome 13.68 10.01 6 95787 265 110493241
Procedural haemorrhage 13.66 10.01 20 95773 5407 110488099
Hypercapnia 13.65 10.01 30 95763 11129 110482377
Nasal mucosal disorder 13.58 10.01 12 95781 1871 110491635
Exophthalmos 13.51 10.01 13 95780 2260 110491246
Vision blurred 13.51 10.01 171 95622 128851 110364655
Chorioretinopathy 13.40 10.01 13 95780 2282 110491224
Brain herniation 13.40 10.01 26 95767 8837 110484669
Glossoptosis 13.39 10.01 6 95787 279 110493227
Allergy to immunoglobulin therapy 13.25 10.01 5 95788 149 110493357
Accelerated idioventricular rhythm 13.25 10.01 6 95787 286 110493220
Memory impairment 13.24 10.01 108 95685 196836 110296670
Angioedema 13.21 10.01 137 95656 98363 110395143
Myokymia 13.19 10.01 5 95788 151 110493355
Viral infection 13.17 10.01 85 95708 53054 110440452
Malaise 13.15 10.01 463 95330 671356 109822150
Back injury 13.11 10.01 13 95780 47386 110446120
Oxidative stress 13.05 10.01 4 95789 62 110493444
C-reactive protein 12.98 10.01 5 95788 30326 110463180
Lethargy 12.96 10.01 131 95662 93445 110400061
Spinal stroke 12.93 10.01 4 95789 64 110493442
Taste disorder 12.92 10.01 23 95770 65364 110428142
Vitreous floaters 12.85 10.01 26 95767 9108 110484398
Obstruction 12.78 10.01 20 95773 5732 110487774
Acute pulmonary oedema 12.76 10.01 38 95755 16958 110476548
Calcinosis 12.76 10.01 14 95779 2838 110490668
Tinnitus 12.73 10.01 93 95700 60447 110433059
Postictal state 12.70 10.01 13 95780 2433 110491073
Meningitis 12.69 10.01 30 95763 11672 110481834
Nasopharyngitis 12.68 10.01 253 95540 394108 110099398
Femoral nerve injury 12.65 10.01 4 95789 69 110493437
Retinal detachment 12.63 10.01 29 95764 11071 110482435
Hyperlipidaemia 12.63 10.01 63 95730 35785 110457721
Depression 12.62 10.01 196 95597 317139 110176367
Dystonia 12.61 10.01 50 95743 25755 110467751
Abortion spontaneous 12.58 10.01 7 95786 34275 110459231
Hypoventilation 12.57 10.01 24 95769 8057 110485449
Allodynia 12.54 10.01 12 95781 2071 110491435
Intentional product use issue 12.43 10.01 146 95647 247760 110245746
Anticoagulant therapy 12.41 10.01 19 95774 5342 110488164
Opisthotonus 12.39 10.01 8 95785 778 110492728
Product administered at inappropriate site 12.33 10.01 19 95774 5374 110488132
Injury 12.33 10.01 219 95574 177046 110316460
Transferrin decreased 12.31 10.01 7 95786 541 110492965
Exostosis 12.26 10.01 13 95780 45943 110447563
Erythema 12.26 10.01 335 95458 291112 110202394
Diabetic ketoacidosis 12.26 10.01 11 95782 42047 110451459
Blindness transient 12.26 10.01 20 95773 5936 110487570
Orbital infection 12.26 10.01 5 95788 184 110493322
Dysarthria 12.25 10.01 119 95674 84002 110409504
Iron binding capacity total decreased 12.09 10.01 7 95786 560 110492946
Antacid therapy 12.09 10.01 19 95774 5465 110488041
Myotonic dystrophy 12.01 10.01 5 95788 194 110493312
White blood cell count decreased 11.93 10.01 134 95659 229256 110264250
Metastases to liver 11.91 10.01 8 95785 35378 110458128
Pupillary reflex impaired 11.90 10.01 16 95777 3999 110489507
Atelectasis 11.88 10.01 63 95730 36649 110456857
Accidental exposure to product 11.80 10.01 79 95714 49929 110443577
Procedural anxiety 11.73 10.01 8 95785 853 110492653
Arthritis fungal 11.73 10.01 5 95788 206 110493300
Intentional product misuse to child 11.71 10.01 5 95788 207 110493299
Exposure during pregnancy 11.70 10.01 207 95586 167217 110326289
Diplegia 11.62 10.01 12 95781 2269 110491237
Deafness bilateral 11.62 10.01 13 95780 2691 110490815
Victim of chemical submission 11.58 10.01 8 95785 871 110492635
Asthma 11.57 10.01 150 95643 250141 110243365
Jaundice 11.55 10.01 21 95772 59215 110434291
Poor quality product administered 11.53 10.01 17 95776 4624 110488882
Cytokine release syndrome 11.52 10.01 102 95691 70204 110423302
End-tidal CO2 decreased 11.50 10.01 4 95789 94 110493412
Treatment failure 11.44 10.01 170 95623 277064 110216442
Intraocular pressure fluctuation 11.42 10.01 4 95789 96 110493410
Conjunctival oedema 11.39 10.01 10 95783 1546 110491960
Intercepted medication error 11.36 10.01 9 95784 1207 110492299
Quadriparesis 11.35 10.01 17 95776 4690 110488816
Tongue paralysis 11.28 10.01 7 95786 636 110492870
Inappropriate schedule of product administration 11.26 10.01 243 95550 203394 110290112
Weight decreased 11.23 10.01 314 95479 467743 110025763
Brugada syndrome 11.21 10.01 10 95783 1578 110491928
Amaurosis 11.21 10.01 10 95783 1579 110491927
Melaena 11.20 10.01 27 95766 68730 110424776
Oesophageal obstruction 11.19 10.01 9 95784 1234 110492272
Laboratory test abnormal 11.18 10.01 13 95780 44066 110449440
Vasospasm 11.17 10.01 10 95783 1586 110491920
Induration 11.16 10.01 12 95781 2377 110491129
Anaesthetic complication cardiac 11.08 10.01 4 95789 105 110493401
Diabetes mellitus inadequate control 11.04 10.01 6 95787 29769 110463737
Blood pressure systolic increased 11.00 10.01 36 95757 82955 110410551
Infusion site nodule 10.96 10.01 6 95787 431 110493075
Blood pressure fluctuation 10.96 10.01 31 95762 74793 110418713
Brain injury 10.95 10.01 31 95762 13445 110480061
Premature baby 10.95 10.01 17 95776 4838 110488668
Sinusitis bacterial 10.94 10.01 12 95781 2432 110491074
Pupil fixed 10.93 10.01 15 95778 3823 110489683
Thyrotoxic crisis 10.88 10.01 11 95782 2029 110491477
Coccygectomy 10.73 10.01 3 95790 33 110493473
Sympathectomy 10.73 10.01 3 95790 33 110493473
Application site pain 10.69 10.01 18 95775 5481 110488025
Mean arterial pressure increased 10.67 10.01 4 95789 117 110493389
Injection site joint swelling 10.65 10.01 3 95790 34 110493472
Vascular resistance systemic decreased 10.62 10.01 5 95788 261 110493245
Accidental death 10.56 10.01 17 95776 4992 110488514
Incontinence 10.47 10.01 35 95758 16600 110476906
Glucose tolerance impaired 10.43 10.01 25 95768 9812 110483694
Pneumonia mycoplasmal 10.43 10.01 10 95783 1731 110491775
Cancer pain 10.40 10.01 20 95773 6752 110486754
Tachypnoea 10.38 10.01 64 95729 39331 110454175
Device infusion issue 10.37 10.01 13 95780 3032 110490474
Muscle strain 10.34 10.01 27 95766 11175 110482331
Physical disability 10.31 10.01 17 95776 5089 110488417
Haemorrhagic vasculitis 10.31 10.01 4 95789 129 110493377
Uveitis 10.30 10.01 3 95790 21707 110471799
Poikiloderma 10.29 10.01 6 95787 486 110493020
Infection 10.29 10.01 237 95556 361963 110131543
Anaphylactoid reaction 10.29 10.01 20 95773 6806 110486700
Incision site rash 10.27 10.01 3 95790 39 110493467
Syringomyelia 10.27 10.01 5 95788 281 110493225
Injection site atrophy 10.22 10.01 6 95787 493 110493013
Corneal abrasion 10.20 10.01 9 95784 1400 110492106
Treatment noncompliance 10.14 10.01 31 95762 72959 110420547
Product use in unapproved indication 10.08 10.01 479 95314 446898 110046608
Tracheal deviation 10.08 10.01 5 95788 293 110493213
Gamma-glutamyltransferase increased 10.05 10.01 24 95769 61285 110432221

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 43.55 41.95 11 54 138 113750

Pharmacologic Action:

SourceCodeDescription
ATC N01BB04 NERVOUS SYSTEM
ANESTHETICS
ANESTHETICS, LOCAL
Amides
ATC N01BB54 NERVOUS SYSTEM
ANESTHETICS
ANESTHETICS, LOCAL
Amides
FDA CS M0000897 Amides
MeSH PA D000777 Anesthetics
MeSH PA D000779 Anesthetics, Local
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D018689 Sensory System Agents
FDA EPC N0000175682 Amide Local Anesthetic
FDA PE N0000175976 Local Anesthesia
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35623 anticonvulsant
CHEBI has role CHEBI:36333 local anaesthetic

Related Drugs by ATC class:

N01BB Amides 10 drugs

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

DiseaseRelationSNOMED_IDDOID
Premature ejaculation indication 44001008 DOID:13709
Local anesthesia indication 386761002
Bacterial septicemia contraindication 10001005 DOID:0040085
Sinus tachycardia contraindication 11092001
Myocardial infarction contraindication 22298006 DOID:5844
Shock contraindication 27942005
Parkinsonism contraindication 32798002
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Conduction disorder of the heart contraindication 44808001
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Cerebral arteriosclerosis contraindication 65312002
Diabetes mellitus contraindication 73211009 DOID:9351
Decreased respiratory function contraindication 80954004
Cardiogenic shock contraindication 89138009
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Open wound contraindication 125643001
Seizure disorder contraindication 128613002
Bleeding contraindication 131148009
Angina pectoris contraindication 194828000
Primary dilated cardiomyopathy contraindication 195021004
Heart block contraindication 233916004
Disease of liver contraindication 235856003 DOID:409
Deficiency of cholinesterase contraindication 360607009
Angle-closure glaucoma contraindication 392291006 DOID:13550
Disorder of coronary artery contraindication 414024009
Denuded skin contraindication 418242004




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.81 acidic
pKa2 8.13 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel BLOCKER IC50 4.27 CHEMBL CHEMBL

External reference:

IDSource
4018911 VUID
N0000178903 NUI
D00553 KEGG_DRUG
1786-81-8 SECONDARY_CAS_RN
4018911 VANDF
4019902 VANDF
C0033124 UMLSCUI
CHEMBL1194 ChEMBL_ID
DB00750 DRUGBANK_ID
CHEMBL1200586 ChEMBL_ID
D011318 MESH_DESCRIPTOR_UI
4906 PUBCHEM_CID
7276 IUPHAR_LIGAND_ID
1641 INN_ID
046O35D44R UNII
2557 RXNORM
5352 MMSL
5353 MMSL
d01396 MMSL
001367 NDDF
004574 NDDF
19232009 SNOMEDCT_US
387107003 SNOMEDCT_US
387299004 SNOMEDCT_US
CHEBI:32053 CHEBI
046O35D44R INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Lidocaine and Prilocaine HUMAN PRESCRIPTION DRUG LABEL 2 0121-1002 CREAM 25 mg TOPICAL ANDA 26 sections
Lidocaine and Prilocaine HUMAN PRESCRIPTION DRUG LABEL 2 0168-0357 CREAM 25 mg TOPICAL ANDA 24 sections
LIDOCAINE AND PRILOCAINE HUMAN PRESCRIPTION DRUG LABEL 2 0574-2042 CREAM 25 mg TOPICAL ANDA 21 sections
Lidocaine and Prilocaine HUMAN PRESCRIPTION DRUG LABEL 2 21695-388 CREAM 25 mg TOPICAL ANDA 25 sections
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINE HUMAN PRESCRIPTION DRUG LABEL 2 21922-076 CREAM 25 mg TOPICAL ANDA 23 sections
Lidocaine and Prilocaine HUMAN PRESCRIPTION DRUG LABEL 2 33261-591 CREAM 25 mg TOPICAL ANDA 21 sections
Lidocaine and Prilocaine HUMAN PRESCRIPTION DRUG LABEL 2 42254-195 CREAM 25 mg TOPICAL ANDA 21 sections
Lidocaine and Prilocaine HUMAN PRESCRIPTION DRUG LABEL 2 46708-582 CREAM 25 mg TOPICAL ANDA 13 sections
Lidocaine and Prilocaine HUMAN PRESCRIPTION DRUG LABEL 2 50090-2167 CREAM 25 mg TOPICAL ANDA 20 sections
LIDOCAINE AND PRILOCAINE HUMAN PRESCRIPTION DRUG LABEL 2 50090-6589 CREAM 25 mg TOPICAL ANDA 21 sections
Citanest Forte DENTAL HUMAN PRESCRIPTION DRUG LABEL 2 51004-5801 INJECTION, SOLUTION 40 mg SUBMUCOSAL ANDA 24 sections
Lidocaine and Prilocaine HUMAN PRESCRIPTION DRUG LABEL 2 52565-007 CREAM 25 mg TOPICAL ANDA 27 sections
LIDOCAINE AND PRILOCAINE HUMAN PRESCRIPTION DRUG LABEL 2 54868-5194 CREAM 25 mg TOPICAL ANDA 25 sections
LIDOCAINE AND PRILOCAINE HUMAN PRESCRIPTION DRUG LABEL 2 61919-443 CREAM 25 mg TOPICAL NDA 13 sections
Lidocaine and Prilocaine HUMAN PRESCRIPTION DRUG LABEL 2 62332-582 CREAM 25 mg TOPICAL ANDA 13 sections
LIDOCAINE AND PRILOCAINE HUMAN PRESCRIPTION DRUG LABEL 2 63629-9604 CREAM 25 mg TOPICAL ANDA 21 sections
Oraqix HUMAN PRESCRIPTION DRUG LABEL 2 66312-110 GEL 25 mg PERIODONTAL NDA 27 sections
Citanest Forte DENTAL HUMAN PRESCRIPTION DRUG LABEL 2 66312-580 INJECTION, SOLUTION 40 mg SUBMUCOSAL ANDA 24 sections
Citanest Plain HUMAN PRESCRIPTION DRUG LABEL 1 66312-630 INJECTION, SOLUTION 40 mg SUBMUCOSAL ANDA 24 sections
Lidocaine and Prilocaine HUMAN PRESCRIPTION DRUG LABEL 2 68071-1625 CREAM 25 mg TOPICAL ANDA 22 sections
LIDOCAINE AND PRILOCAINE HUMAN PRESCRIPTION DRUG LABEL 2 68071-3856 CREAM 25 mg TOPICAL ANDA 21 sections
LIDOCAINE AND PRILOCAINE HUMAN PRESCRIPTION DRUG LABEL 2 68788-4090 CREAM 25 mg TOPICAL ANDA 21 sections
Lidocaine and Prilocaine HUMAN PRESCRIPTION DRUG LABEL 2 68788-8150 CREAM 25 mg TOPICAL ANDA 24 sections
Relador Pak with Occlusive Dressing HUMAN PRESCRIPTION DRUG LABEL 2 69166-105 CREAM 25 mg TOPICAL ANDA 26 sections
LIDOPRIL HUMAN PRESCRIPTION DRUG LABEL 2 69336-825 CREAM 25 mg TOPICAL NDA 11 sections
LIDOPRIL XR HUMAN PRESCRIPTION DRUG LABEL 2 69336-826 CREAM 25 mg TOPICAL NDA 11 sections
PRILOLID HUMAN PRESCRIPTION DRUG LABEL 2 69336-828 CREAM 25 mg TOPICAL NDA 11 sections
Lidocaine and prilocaine HUMAN PRESCRIPTION DRUG LABEL 2 70771-1872 CREAM 25 mg TOPICAL ANDA 2 sections
LIDOCAINE AND PRILOCAINE HUMAN PRESCRIPTION DRUG LABEL 2 71335-2716 CREAM 25 mg TOPICAL ANDA 21 sections
LIDOCAINE AND PRILOCAINE HUMAN PRESCRIPTION DRUG LABEL 2 71335-2970 CREAM 25 mg TOPICAL ANDA 21 sections