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

Stem definitionDrug idCAS RN
opioid receptor agonists, analgesics, fentanyl derivatives 1164 437-38-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fentanyl
  • fentanil
  • fentanyl citrate
  • effentora
  • instanyl
  • fentanyl hydrochloride
  • fentanyl HCl
A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance.
  • Molecular weight: 336.48
  • Formula: C22H28N2O
  • CLOGP: 3.62
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 0
  • TPSA: 23.55
  • ALOGS: -4.15
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.60 mg N
0.60 mg SL
1.20 mg TD

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.74 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 8 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.00 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 1 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.89 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 4.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.16 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 3 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AKT2,AKT3,ALK,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MET,MTOR,NTRK2,PAK4,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK 47
kinase-selectivity-class AXL,BRAF,CAMK2D,EIF2AK3,ERBB2,GRK2,PDK4,PRKCD,SIK2,STK33,TEK 11
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
June 29, 2020 PMDA Hisamitsu Pharmaceutical Co., Inc.
Feb. 19, 1968 FDA AKORN
Jan. 24, 2006 EMA Janssen-Cilag International NV

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug abuse 5300.34 10.35 2636 149117 79711 90396983
Toxicity to various agents 1860.19 10.35 2346 149407 285500 90191194
Respiratory arrest 1087.58 10.35 684 151069 32627 90444067
Cardiac arrest 1074.18 10.35 1088 150665 103847 90372847
Serotonin syndrome 807.99 10.35 598 151155 37289 90439405
Cardio-respiratory arrest 803.06 10.35 738 151015 62402 90414292
Product adhesion issue 799.10 10.35 307 151446 4835 90471859
Death 722.30 10.35 2030 149723 454521 90022173
Respiratory depression 672.58 10.35 383 151370 15192 90461502
Drug withdrawal syndrome 567.13 10.35 433 151320 28290 90448404
Systemic lupus erythematosus 522.33 10.35 19 151734 361877 90114817
Drug interaction 507.60 10.35 1300 150453 275153 90201541
Overdose 482.56 10.35 911 150842 156798 90319896
Glossodynia 474.61 10.35 14 151739 321765 90154929
Hand deformity 469.05 10.35 5 151748 296357 90180337
Hypotension 463.72 10.35 1395 150358 324002 90152692
Synovitis 463.43 10.35 21 151732 329731 90146963
Inadequate analgesia 456.73 10.35 180 151573 3044 90473650
Maternal exposure during delivery 449.47 10.35 187 151566 3659 90473035
Anaphylactic reaction 443.40 10.35 635 151118 86889 90389805
Alopecia 439.77 10.35 141 151612 494930 89981764
Pericarditis 386.89 10.35 15 151738 270136 90206558
Completed suicide 385.62 10.35 790 150963 144268 90332426
Arthropathy 369.22 10.35 81 151672 366161 90110533
Helicobacter infection 358.10 10.35 4 151749 226846 90249848
Bradycardia 347.43 10.35 554 151199 83293 90393401
Wound 346.84 10.35 48 151705 302932 90173762
Unresponsive to stimuli 339.06 10.35 367 151386 37754 90438940
Joint swelling 332.63 10.35 217 151536 503083 89973611
Prescription drug used without a prescription 319.95 10.35 140 151613 3115 90473579
Accidental overdose 316.36 10.35 308 151445 27965 90448729
Apnoea 313.88 10.35 196 151557 9218 90467476
Incorrect route of product administration 313.50 10.35 405 151348 50221 90426473
Folliculitis 312.29 10.35 6 151747 204347 90272347
Delayed recovery from anaesthesia 303.71 10.35 99 151654 931 90475763
Infusion related reaction 291.56 10.35 168 151585 416612 90060082
Hepatic enzyme increased 279.74 10.35 127 151626 360609 90116085
Irritable bowel syndrome 279.43 10.35 17 151736 207431 90269263
Somnolence 277.51 10.35 875 150878 208209 90268485
Muscle injury 274.87 10.35 4 151749 176650 90300044
Type 2 diabetes mellitus 263.98 10.35 20 151733 203224 90273470
Intentional product misuse 263.24 10.35 509 151244 89095 90387599
Nasopharyngitis 258.84 10.35 183 151570 406921 90069773
Abdominal discomfort 255.07 10.35 254 151499 477074 89999620
Withdrawal syndrome 249.43 10.35 244 151509 22280 90454414
Swelling 247.74 10.35 203 151550 418855 90057839
Product prescribing error 245.24 10.35 277 151476 29868 90446826
Wrong technique in product usage process 242.10 10.35 432 151321 71139 90405555
Lower respiratory tract infection 241.49 10.35 61 151692 250598 90226096
Psoriatic arthropathy 241.43 10.35 45 151708 228290 90248404
Sinusitis 240.30 10.35 138 151615 342950 90133744
Anaesthetic complication 222.91 10.35 100 151653 2365 90474329
Depressed level of consciousness 221.82 10.35 420 151333 72364 90404330
Drug intolerance 221.45 10.35 254 151499 447337 90029357
Miosis 220.95 10.35 158 151595 9326 90467368
Drug dependence 219.26 10.35 258 151495 29069 90447625
Rash 207.76 10.35 664 151089 795436 89681258
Contraindicated product administered 207.27 10.35 141 151612 319998 90156696
C-reactive protein abnormal 197.73 10.35 3 151750 127426 90349268
Fibromyalgia 197.12 10.35 51 151702 206218 90270476
Arthralgia 190.32 10.35 668 151085 777854 89698840
Agitation 189.56 10.35 375 151378 66723 90409971
Myoclonus 189.02 10.35 195 151558 18973 90457721
Blood cholesterol increased 188.41 10.35 57 151696 207955 90268739
Hypersensitivity 186.42 10.35 296 151457 454381 90022313
Ill-defined disorder 183.93 10.35 42 151711 184849 90291845
Treatment failure 179.79 10.35 147 151606 303781 90172913
Hyperaesthesia 174.05 10.35 144 151609 10558 90466136
Liver injury 171.16 10.35 38 151715 170529 90306165
Product complaint 169.94 10.35 157 151596 13343 90463351
Product quality issue 168.54 10.35 395 151358 78930 90397764
Drug use disorder 167.34 10.35 127 151626 8216 90468478
Stomatitis 167.33 10.35 129 151624 274569 90202125
Discomfort 166.89 10.35 129 151624 274206 90202488
Procedural hypotension 164.38 10.35 71 151682 1529 90475165
Oxygen saturation decreased 163.34 10.35 472 151281 107011 90369683
Weight increased 162.98 10.35 281 151472 417646 90059048
Peripheral swelling 161.79 10.35 277 151476 412829 90063865
Blister 161.45 10.35 115 151638 254883 90221811
Respiratory failure 154.60 10.35 493 151260 117925 90358769
Stress cardiomyopathy 154.11 10.35 148 151605 13207 90463487
Wheezing 151.20 10.35 107 151646 237973 90238721
Pulmonary oedema 149.58 10.35 325 151428 61755 90414939
Bronchospasm 146.27 10.35 177 151576 20532 90456162
Neuromuscular block prolonged 146.15 10.35 51 151702 601 90476093
Facet joint syndrome 145.96 10.35 4 151749 98385 90378309
Asthma 145.85 10.35 115 151638 242045 90234649
Hypoxia 145.69 10.35 353 151400 72046 90404648
Constipation 143.55 10.35 881 150872 279514 90197180
Lip dry 143.10 10.35 6 151747 100949 90375745
Myoglobin urine present 142.08 10.35 52 151701 710 90475984
Pleural fibrosis 140.79 10.35 83 151670 3513 90473181
Bradypnoea 140.39 10.35 91 151662 4567 90472127
Coma 139.64 10.35 348 151405 72284 90404410
Urinary retention 139.55 10.35 237 151516 37507 90439187
Premature delivery 138.86 10.35 240 151513 38522 90438172
Blood potassium increased 137.92 10.35 172 151581 20577 90456117
Presbyacusis 137.23 10.35 77 151676 2965 90473729
Respiratory acidosis 135.71 10.35 111 151642 8008 90468686
Encephalopathy 135.33 10.35 263 151490 46181 90430513
Product use issue 134.92 10.35 215 151538 329704 90146990
Deafness neurosensory 134.70 10.35 103 151650 6738 90469956
Respiratory rate decreased 132.96 10.35 83 151670 3900 90472794
Application site rash 132.61 10.35 72 151681 2597 90474097
Joint range of motion decreased 132.54 10.35 32 151721 135611 90341083
Hypercholesterolaemia 127.97 10.35 11 151742 100881 90375813
Mobility decreased 126.35 10.35 140 151613 250594 90226100
Tachycardia 123.88 10.35 558 151195 157115 90319579
Rheumatoid arthritis 123.69 10.35 264 151489 362350 90114344
Anaphylactic shock 122.85 10.35 203 151550 31414 90445280
Hypoventilation 122.84 10.35 88 151665 5208 90471486
Grip strength decreased 120.47 10.35 9 151744 92567 90384127
Peripheral venous disease 118.90 10.35 5 151748 83916 90392778
Blood pressure decreased 118.73 10.35 334 151419 74561 90402133
Inflammation 116.38 10.35 78 151675 178514 90298180
Condition aggravated 115.29 10.35 559 151194 594986 89881708
Anterior spinal artery syndrome 114.41 10.35 32 151721 167 90476527
White blood cell count abnormal 113.84 10.35 97 151656 7407 90469287
Brain oedema 112.18 10.35 142 151611 17243 90459451
Gastrointestinal disorder 110.96 10.35 161 151592 256526 90220168
Impaired healing 110.24 10.35 138 151615 234061 90242633
Headache 109.95 10.35 921 150832 861825 89614869
Restlessness 108.64 10.35 206 151547 35514 90441180
Circulatory collapse 107.85 10.35 168 151585 24736 90451958
Disorientation 107.47 10.35 232 151521 43882 90432812
Faecaloma 106.25 10.35 108 151645 10323 90466371
Blood magnesium increased 106.22 10.35 68 151685 3340 90473354
Pleural thickening 104.20 10.35 66 151687 3182 90473512
Fatigue 103.36 10.35 1339 150414 1152684 89324010
Hip arthroplasty 103.31 10.35 6 151747 76202 90400492
Knee arthroplasty 103 10.35 10 151743 83172 90393522
Kounis syndrome 102.78 10.35 60 151693 2493 90474201
Pruritus 102.64 10.35 512 151241 541013 89935681
Renal failure 102.42 10.35 463 151290 130544 90346150
Accidental exposure to product by child 101.52 10.35 48 151705 1285 90475409
Poisoning 100.91 10.35 126 151627 15091 90461603
Hyperthermia malignant 99.65 10.35 47 151706 1251 90475443
Pulseless electrical activity 99.33 10.35 97 151656 8835 90467859
Plasma cell myeloma 97.50 10.35 213 151540 40615 90436079
Malignant neoplasm progression 94.49 10.35 392 151361 106478 90370216
Mental status changes 93.27 10.35 221 151532 44458 90432236
Application site erythema 92.98 10.35 74 151679 5134 90471560
Substance abuse 92.65 10.35 75 151678 5331 90471363
Bursitis 92.00 10.35 53 151700 131601 90345093
Injection site pain 91.94 10.35 93 151660 173606 90303088
Pulmonary fibrosis 91.10 10.35 33 151720 107470 90369224
Autoimmune disorder 90.51 10.35 11 151742 76733 90399961
Drug screen positive 88.46 10.35 63 151690 3694 90473000
Osteopenia 88.44 10.35 147 151606 22855 90453839
Labile blood pressure 87.94 10.35 49 151704 1861 90474833
Multiple organ dysfunction syndrome 87.78 10.35 283 151470 68053 90408641
Sepsis 86.95 10.35 557 151196 179257 90297437
Drug diversion 86.86 10.35 40 151713 1007 90475687
Cough 86.27 10.35 322 151431 368640 90108054
Muscle rigidity 86.25 10.35 113 151640 14196 90462498
Generalised tonic-clonic seizure 84.38 10.35 183 151570 34720 90441974
Injection site reaction 83.76 10.35 25 151728 92055 90384639
Red blood cell sedimentation rate increased 83.65 10.35 18 151735 82577 90394117
Neoplasm progression 83.24 10.35 211 151542 44275 90432419
Toxic encephalopathy 83.07 10.35 87 151666 8612 90468082
Altered state of consciousness 82.80 10.35 171 151582 31361 90445333
Ventricular tachycardia 82.05 10.35 148 151605 24560 90452134
Obesity 81.89 10.35 37 151716 105470 90371224
Application site pruritus 81.55 10.35 63 151690 4184 90472510
Dehydration 80.69 10.35 580 151173 193867 90282827
Fear 80.31 10.35 118 151635 16504 90460190
Loss of consciousness 80.29 10.35 454 151299 139784 90336910
Delirium 79.45 10.35 366 151387 103993 90372701
Lower limb fracture 79.32 10.35 22 151731 84991 90391703
Liver disorder 78.94 10.35 53 151700 121216 90355478
Off label use 78.79 10.35 1336 150417 1100916 89375778
Application site vesicles 78.37 10.35 42 151711 1475 90475219
Hallucination 78.33 10.35 266 151487 65693 90411001
Epigastric discomfort 78.26 10.35 79 151674 7489 90469205
Abdominal pain upper 77.98 10.35 290 151463 332384 90144310
Amylase increased 77.15 10.35 76 151677 6996 90469698
Renal impairment 75.34 10.35 363 151390 105058 90371636
Adjustment disorder with depressed mood 75.33 10.35 5 151748 56748 90419946
Gastrooesophageal reflux disease 75.18 10.35 101 151652 166236 90310458
Opiates positive 75.00 10.35 26 151727 300 90476394
Haemodynamic instability 74.35 10.35 95 151658 11644 90465050
Hypermobility syndrome 73.68 10.35 34 151719 860 90475834
Contusion 73.61 10.35 198 151555 251018 90225676
Sedation 73.58 10.35 212 151541 47959 90428735
Anaemia 72.10 10.35 905 150848 351897 90124797
Toxic leukoencephalopathy 72.05 10.35 33 151720 820 90475874
Infection 71.63 10.35 337 151416 361757 90114937
Wound infection 71.30 10.35 45 151708 106357 90370337
Lung disorder 70.84 10.35 88 151665 149795 90326899
Radiculopathy 70.80 10.35 118 151635 18387 90458307
Hyperhidrosis 70.73 10.35 430 151323 135875 90340819
Post procedural complication 69.63 10.35 119 151634 18923 90457771
Nausea 68.37 10.35 2382 149371 1107934 89368760
Metabolic acidosis 68.30 10.35 227 151526 55449 90421245
Blepharospasm 67.77 10.35 7 151746 55438 90421256
Femoral hernia incarcerated 67.56 10.35 38 151715 1470 90475224
Wound infection pseudomonas 67.13 10.35 42 151711 1981 90474713
Female genital tract fistula 67.11 10.35 113 151640 17755 90458939
Infusion site coldness 66.92 10.35 22 151731 213 90476481
Troponin increased 66.66 10.35 96 151657 13185 90463509
Nail disorder 66.02 10.35 10 151743 59057 90417637
Lymphatic fistula 65.95 10.35 37 151716 1424 90475270
Emotional distress 65.61 10.35 171 151582 36491 90440203
Psoriasis 65.47 10.35 91 151662 147663 90329031
Urticaria 65.47 10.35 285 151468 312449 90164245
Taste disorder 65.28 10.35 12 151741 61534 90415160
Sciatica 63.75 10.35 46 151707 101336 90375358
Night sweats 62.54 10.35 74 151679 128692 90348002
Hypoaesthesia 62.38 10.35 292 151461 313918 90162776
Therapeutic product effect increased 61.65 10.35 34 151719 1265 90475429
Ear infection 61.57 10.35 20 151733 69755 90406939
Vaginal flatulence 61.46 10.35 90 151663 12548 90464146
Pain in extremity 60.85 10.35 473 151280 450056 90026638
Prescribed underdose 60.29 10.35 25 151728 74994 90401700
Procedural complication 60.13 10.35 61 151692 5817 90470877
Dry mouth 59.41 10.35 138 151615 183921 90292773
Pancreatic steatosis 59.35 10.35 36 151717 1606 90475088
Gait inability 59.27 10.35 96 151657 146360 90330334
Sleep disorder 58.82 10.35 155 151598 197875 90278819
Bone cyst 58.59 10.35 41 151712 2337 90474357
Onychomadesis 58.37 10.35 5 151748 45993 90430701
Application site irritation 58.34 10.35 38 151715 1923 90474771
COVID-19 58.27 10.35 122 151631 168721 90307973
Intercepted product dispensing error 58.12 10.35 18 151735 141 90476553
Proctitis 57.97 10.35 97 151656 15162 90461532
Gamma-glutamyltransferase decreased 57.68 10.35 22 151731 339 90476355
Memory impairment 56.62 10.35 157 151596 197087 90279607
Adverse event 56.47 10.35 68 151685 117350 90359344
Arterial haemorrhage 56.41 10.35 41 151712 2482 90474212
Device expulsion 56.09 10.35 3 151750 40883 90435811
Clonus 55.79 10.35 58 151695 5692 90471002
Seroma 55.74 10.35 44 151709 3016 90473678
Rhythm idioventricular 55.55 10.35 22 151731 377 90476317
Cyanosis 55.24 10.35 109 151644 19346 90457348
Therapy naive 55.24 10.35 13 151740 28 90476666
Joint stiffness 55.11 10.35 31 151722 78011 90398683
Allodynia 54.73 10.35 29 151724 995 90475699
Application site reaction 54.49 10.35 27 151726 803 90475891
Prescribed overdose 54.28 10.35 50 151703 97575 90379119
Bradycardia foetal 54.03 10.35 24 151729 554 90476140
Application site pain 53.88 10.35 52 151701 4668 90472026
Breakthrough pain 53.84 10.35 32 151721 1375 90475319
Neuromuscular blockade 53.83 10.35 21 151732 345 90476349
Vasodilatation 53.68 10.35 42 151711 2842 90473852
Endotracheal intubation complication 52.94 10.35 22 151731 429 90476265
Vomiting 52.65 10.35 1708 150045 786585 89690109
Pregnancy 52.64 10.35 19 151734 62028 90414666
Musculoskeletal stiffness 52.35 10.35 287 151466 296245 90180449
Tracheal deviation 52.07 10.35 19 151734 257 90476437
Haematemesis 52.06 10.35 149 151604 33577 90443117
Injury 51.65 10.35 164 151589 197185 90279509
Myelosuppression 51.64 10.35 13 151740 53578 90423116
Renal injury 51.35 10.35 74 151679 10169 90466525
Dependence 51.34 10.35 36 151717 2059 90474635
Amnestic disorder 51.23 10.35 21 151732 395 90476299
Therapeutic product effect decreased 50.46 10.35 266 151487 277305 90199389
Osteosclerosis 50.08 10.35 48 151705 4272 90472422
Cardiogenic shock 49.95 10.35 120 151633 24348 90452346
Respiratory distress 49.75 10.35 161 151592 38785 90437909
Systemic infection 49.66 10.35 50 151703 4725 90471969
Injection site erythema 49.57 10.35 55 151698 98447 90378247
Laryngitis 49.51 10.35 12 151741 50741 90425953
Acute respiratory failure 49.13 10.35 171 151582 42747 90433947
Metastases to bone 48.79 10.35 122 151631 25383 90451311
Hypoxic-ischaemic encephalopathy 48.77 10.35 49 151704 4619 90472075
Monoplegia 48.72 10.35 44 151709 3630 90473064
Mydriasis 48.67 10.35 89 151664 14923 90461771
Osteoarthritis 48.23 10.35 167 151586 195563 90281131
Anhedonia 47.95 10.35 76 151677 11355 90465339
Therapeutic product effect prolonged 47.94 10.35 20 151733 394 90476300
Neurotoxicity 47.88 10.35 109 151644 21358 90455336
Substance use 47.80 10.35 28 151725 1171 90475523
Phrenic nerve paralysis 47.68 10.35 19 151734 331 90476363
Stridor 47.68 10.35 49 151704 4744 90471950
Upper respiratory tract infection 47.47 10.35 89 151664 128229 90348465
Spinal cord injury 47.14 10.35 27 151726 1082 90475612
Carcinoid crisis 47.04 10.35 18 151735 280 90476414
Hepatic ischaemia 47.03 10.35 24 151729 761 90475933
Therapeutic product effect incomplete 46.73 10.35 167 151586 193729 90282965
Tachyarrhythmia 46.23 10.35 51 151702 5355 90471339
Myocardial ischaemia 46.19 10.35 83 151670 13731 90462963
Foot deformity 46.15 10.35 21 151732 59630 90417064
Product administration error 46.01 10.35 122 151631 26301 90450393
Hypertension 45.99 10.35 517 151236 457015 90019679
Arthritis 45.94 10.35 136 151617 167179 90309515
Haemarthrosis 45.58 10.35 44 151709 3950 90472744
Hepatic failure 45.23 10.35 158 151595 39570 90437124
Abortion spontaneous 45.10 10.35 17 151736 54039 90422655
Onychomycosis 44.96 10.35 5 151748 37371 90439323
Influenza 44.47 10.35 105 151648 139159 90337535
Airway peak pressure increased 44.42 10.35 19 151734 399 90476295
Laryngospasm 44.37 10.35 40 151713 3293 90473401
Muscle spasms 44.33 10.35 244 151509 251639 90225055
Hypothermia 43.91 10.35 87 151666 15488 90461206
Dystonia 43.91 10.35 91 151662 16728 90459966
C-reactive protein increased 43.86 10.35 156 151597 181233 90295461
Cancer pain 43.43 10.35 43 151710 3982 90472712
Pulse absent 43.16 10.35 52 151701 6003 90470691
Coagulopathy 43.08 10.35 110 151643 23179 90453515
Recurrence of neuromuscular blockade 42.37 10.35 15 151738 185 90476509
Osteoporosis 42.21 10.35 60 151693 96471 90380223
Hepatic cirrhosis 42.03 10.35 27 151726 63226 90413468
Unwanted awareness during anaesthesia 41.48 10.35 18 151735 392 90476302
Vaginal discharge 41.40 10.35 97 151656 19367 90457327
Coma scale abnormal 41.22 10.35 49 151704 5577 90471117
Ventilation perfusion mismatch 41.08 10.35 20 151733 572 90476122
Acute kidney injury 40.65 10.35 758 150995 319629 90157065
Blood lactate dehydrogenase increased 40.45 10.35 115 151638 25817 90450877
Airway complication of anaesthesia 40.42 10.35 18 151735 418 90476276
Ventricular fibrillation 40.26 10.35 79 151674 13965 90462729
Spinal cord infarction 40.19 10.35 17 151736 347 90476347
Endotracheal intubation 40.18 10.35 38 151715 3326 90473368
Delusion of parasitosis 40.09 10.35 13 151740 120 90476574
Back injury 40.02 10.35 14 151739 46608 90430086
Product counterfeit 39.96 10.35 14 151739 167 90476527
Spontaneous haemorrhage 39.86 10.35 21 151732 712 90475982
Atrioventricular block second degree 39.81 10.35 43 151710 4409 90472285
Drug tolerance decreased 39.41 10.35 4 151749 32126 90444568
Mental status changes postoperative 38.74 10.35 14 151739 184 90476510
Oedema 38.64 10.35 188 151565 200107 90276587
Paralysis 38.42 10.35 69 151684 11409 90465285
Exposure during pregnancy 38.25 10.35 586 151167 237824 90238870
Finger deformity 38.10 10.35 5 151748 32892 90443802
Brain death 38.01 10.35 40 151713 3981 90472713
Cyst 37.95 10.35 85 151668 16476 90460218
Dyskinesia 37.94 10.35 141 151612 36393 90440301
Acute respiratory distress syndrome 37.92 10.35 120 151633 28566 90448128
Caesarean section 37.80 10.35 91 151662 18486 90458208
Procedural pain 37.39 10.35 132 151621 33228 90443466
Drug abuser 37.23 10.35 33 151720 2657 90474037
Horner's syndrome 37.17 10.35 9 151744 23 90476671
Cauda equina syndrome 37.06 10.35 25 151728 1342 90475352
Local anaesthetic systemic toxicity 37.04 10.35 37 151716 3463 90473231
Product use in unapproved indication 36.97 10.35 372 151381 335864 90140830
Pneumonia aspiration 36.82 10.35 151 151602 40789 90435905
Wound dehiscence 36.69 10.35 47 151706 5775 90470919
Hepatorenal syndrome 36.35 10.35 29 151724 2019 90474675
Streptococcal sepsis 36.31 10.35 37 151716 3547 90473147
Pneumothorax 35.94 10.35 91 151662 19076 90457618
Rhabdomyolysis 35.53 10.35 175 151578 51081 90425613
Supraventricular tachycardia 35.39 10.35 82 151671 16254 90460440
Myotonia 35.22 10.35 13 151740 182 90476512
Spinal epidural haematoma 35.22 10.35 24 151729 1310 90475384
Wrong product administered 35.00 10.35 53 151700 7612 90469082
Drug-induced liver injury 34.88 10.35 61 151692 90257 90386437
Procedural hypertension 34.73 10.35 15 151738 323 90476371
Aortic valve stenosis 34.54 10.35 39 151714 4201 90472493
Road traffic accident 34.47 10.35 81 151672 107545 90369149
Blood creatine phosphokinase increased 34.24 10.35 130 151623 33893 90442801
Infusion site induration 34.10 10.35 25 151728 1534 90475160
Epilepsy 34.09 10.35 53 151700 82153 90394541
Bronchitis 34.06 10.35 136 151617 152791 90323903
Amphetamines positive 33.93 10.35 13 151740 203 90476491
Oral candidiasis 33.66 10.35 133 151620 35322 90441372
Anaesthetic complication pulmonary 33.64 10.35 10 151743 67 90476627
Exposure via ingestion 33.53 10.35 31 151722 2636 90474058
Therapy non-responder 33.42 10.35 117 151636 136587 90340107
Cardiac output decreased 33.40 10.35 21 151732 999 90475695
Therapeutic response decreased 33.39 10.35 62 151691 89667 90387027
Intestinal pseudo-obstruction 33.29 10.35 22 151731 1141 90475553
Hyperreflexia 33.23 10.35 48 151705 6609 90470085
Visual impairment 33.23 10.35 112 151641 132253 90344441
Brain injury 33.22 10.35 52 151701 7686 90469008
Ulcer haemorrhage 33.02 10.35 3 151750 26318 90450376
Acute postoperative sialadenitis 33.01 10.35 9 151744 42 90476652
Unevaluable event 32.99 10.35 180 151573 54668 90422026
Arachnoid web 32.92 10.35 7 151746 7 90476687
Product dose omission issue 31.94 10.35 323 151430 291364 90185330
Adverse drug reaction 31.93 10.35 95 151658 116606 90360088
Type I hypersensitivity 31.79 10.35 37 151716 4118 90472576
Application site burn 31.76 10.35 20 151733 954 90475740
Anorectal ulcer 31.71 10.35 9 151744 50 90476644
Nasal congestion 31.61 10.35 57 151696 83357 90393337
Non-consummation 31.27 10.35 9 151744 53 90476641
Hypercreatininaemia 31.12 10.35 18 151735 735 90475959
Anticholinergic syndrome 30.90 10.35 30 151723 2713 90473981
Pseudomonal sepsis 30.75 10.35 37 151716 4265 90472429
Lethargy 30.74 10.35 196 151557 62943 90413751
Paraplegia 30.59 10.35 33 151720 3379 90473315
Injection site swelling 30.56 10.35 33 151720 59806 90416888
Mean arterial pressure decreased 30.28 10.35 12 151741 206 90476488
Product tampering 30.22 10.35 15 151738 448 90476246
Leukoencephalopathy 30.17 10.35 39 151714 4834 90471860
Listless 30.14 10.35 32 151721 3217 90473477
Application site dermatitis 29.93 10.35 11 151742 152 90476542
Breast cancer metastatic 29.59 10.35 73 151680 15059 90461635
Sinus tachycardia 29.57 10.35 110 151643 28403 90448291
Anuria 29.52 10.35 72 151681 14746 90461948
Muscle relaxant therapy 29.30 10.35 11 151742 162 90476532
Ocular hyperaemia 29.27 10.35 10 151743 33788 90442906
Cachexia 29.22 10.35 46 151707 6832 90469862
Product packaging quantity issue 29.11 10.35 23 151730 1579 90475115
Uterine hypertonus 28.95 10.35 13 151740 308 90476386
Confusion postoperative 28.64 10.35 12 151741 239 90476455
Product packaging issue 28.62 10.35 23 151730 1618 90475076
Non-small cell lung cancer 28.61 10.35 36 151717 4345 90472349
Dermatitis atopic 28.59 10.35 3 151750 23469 90453225
Postpartum haemorrhage 28.44 10.35 27 151726 2374 90474320
Cardiovascular disorder 28.44 10.35 67 151686 13425 90463269
Nasal mucosal disorder 28.16 10.35 24 151729 1833 90474861
Apnoeic attack 28.13 10.35 13 151740 330 90476364
Accidental death 28.09 10.35 25 151728 2023 90474671
Pleural effusion 28.06 10.35 299 151454 111692 90365002
Spinal anaesthesia 27.96 10.35 9 151744 81 90476613
Electrocardiogram ST segment elevation 27.83 10.35 34 151719 3982 90472712
Hyperkalaemia 27.62 10.35 195 151558 64769 90411925
Hypovolaemia 27.59 10.35 63 151690 12368 90464326
Product monitoring error 27.56 10.35 36 151717 4508 90472186
Arteriospasm coronary 27.56 10.35 38 151715 5012 90471682
Torsade de pointes 27.35 10.35 71 151682 15111 90461583
Diarrhoea 26.94 10.35 1292 150461 937898 89538796
Product administered at inappropriate site 26.93 10.35 34 151719 4117 90472577
Postoperative delirium 26.93 10.35 11 151742 205 90476489
Osteomyelitis 26.88 10.35 105 151648 27741 90448953
Documented hypersensitivity to administered product 26.70 10.35 16 151737 698 90475996
Disturbance in social behaviour 26.69 10.35 34 151719 4154 90472540
Intensive care unit delirium 26.61 10.35 8 151745 56 90476638
Intentional self-injury 26.61 10.35 8 151745 29326 90447368
Resuscitation 26.59 10.35 20 151733 1276 90475418
Anaphylactoid reaction 26.49 10.35 35 151718 4433 90472261
Anterograde amnesia 26.35 10.35 15 151738 594 90476100
Quadriplegia 26.26 10.35 25 151728 2206 90474488
Electrocardiogram ST segment depression 26.26 10.35 30 151723 3273 90473421
Nystagmus 26.21 10.35 45 151708 7182 90469512
Skin sensitisation 26.18 10.35 18 151735 997 90475697
Neurosis 26.07 10.35 13 151740 392 90476302
Propofol infusion syndrome 26.01 10.35 20 151733 1319 90475375
Upper airway obstruction 25.91 10.35 18 151735 1014 90475680
Procedural nausea 25.87 10.35 19 151734 1169 90475525
Post procedural haemorrhage 25.84 10.35 50 151703 8748 90467946
Diverticulum intestinal 25.69 10.35 51 151702 9091 90467603
Dizziness 25.67 10.35 771 150982 588513 89888181
Septic shock 25.62 10.35 234 151519 83926 90392768
Sneezing 25.58 10.35 9 151744 29860 90446834
Seizure 25.57 10.35 378 151375 152251 90324443
Loss of personal independence in daily activities 25.52 10.35 129 151624 135976 90340718
Aortic arteriosclerosis 25.48 10.35 46 151707 7638 90469056
Basal cell carcinoma 25.45 10.35 12 151741 33377 90443317
Hepatic cyst 25.28 10.35 42 151711 6526 90470168
Left ventricle outflow tract obstruction 25.28 10.35 13 151740 419 90476275
Product label confusion 25.23 10.35 4 151749 22846 90453848
Pelvic fracture 25.22 10.35 69 151684 15150 90461544
Nail bed inflammation 24.74 10.35 22 151731 1779 90474915
Eye irritation 24.71 10.35 13 151740 33965 90442729
Sphincter of Oddi dysfunction 24.62 10.35 13 151740 443 90476251
Apathy 24.56 10.35 56 151697 10984 90465710
Pulmonary congestion 24.51 10.35 80 151673 19353 90457341
Tachypnoea 24.47 10.35 85 151668 21224 90455470
Retinal detachment 24.11 10.35 42 151711 6780 90469914
Therapy interrupted 24.11 10.35 29 151724 50079 90426615
Retinopathy of prematurity 24.06 10.35 12 151741 362 90476332
Left ventricular dysfunction 23.81 10.35 66 151687 14603 90462091
Walking aid user 23.80 10.35 15 151738 35491 90441203
Opisthotonus 23.67 10.35 12 151741 375 90476319
Hypopnoea 23.67 10.35 33 151720 4398 90472296
Narcotic bowel syndrome 23.64 10.35 9 151744 138 90476556
Anaesthetic complication neurological 23.63 10.35 15 151738 726 90475968
Medication error 23.59 10.35 231 151522 84421 90392273
Shock 23.44 10.35 103 151650 28675 90448019
Reduced facial expression 23.43 10.35 25 151728 2528 90474166
Postoperative wound infection 23.38 10.35 62 151691 13364 90463330
Post lumbar puncture syndrome 23.36 10.35 16 151737 881 90475813
Pituitary apoplexy 23.35 10.35 9 151744 143 90476551
Conversion disorder 23.29 10.35 23 151730 2123 90474571
Abscess neck 23.26 10.35 15 151738 746 90475948
Pseudopolyp 23.19 10.35 12 151741 392 90476302
Deformity 23.05 10.35 58 151695 12112 90464582
Tricuspid valve incompetence 23.05 10.35 71 151682 16660 90460034
Food allergy 23.01 10.35 7 151746 25471 90451223
Counterfeit product administered 22.95 10.35 8 151745 94 90476600
Metastases to central nervous system 22.84 10.35 73 151680 17469 90459225
Psychomotor skills impaired 22.69 10.35 26 151727 2846 90473848
Acute hepatic failure 22.53 10.35 86 151667 22475 90454219
Spinal cord compression 22.49 10.35 34 151719 4877 90471817
Pleural neoplasm 22.46 10.35 12 151741 419 90476275
Mastocytosis 22.44 10.35 16 151737 940 90475754
Disseminated intravascular coagulation 22.26 10.35 83 151670 21455 90455239
Hypercapnia 22.17 10.35 40 151713 6637 90470057
Drug screen negative 22.08 10.35 11 151742 331 90476363
Generalised onset non-motor seizure 22.00 10.35 6 151747 28 90476666
Post-traumatic neck syndrome 21.99 10.35 24 151729 2490 90474204
Neck pain 21.95 10.35 107 151646 113856 90362838
Vaccination site reaction 21.89 10.35 10 151743 247 90476447
Groin pain 21.88 10.35 57 151696 12156 90464538
Drug withdrawal syndrome neonatal 21.80 10.35 23 151730 2296 90474398
Fluid retention 21.79 10.35 75 151678 88016 90388678
Postmortem blood drug level 21.74 10.35 8 151745 111 90476583
Ventricular hypokinesia 21.70 10.35 35 151718 5306 90471388
Potentiating drug interaction 21.52 10.35 36 151717 5626 90471068
Sopor 21.45 10.35 90 151663 24554 90452140
Posterior reversible encephalopathy syndrome 21.37 10.35 84 151669 22255 90454439
Ear pain 21.35 10.35 40 151713 57662 90419032
Laryngeal oedema 21.31 10.35 40 151713 6841 90469853
Vasoconstriction 21.20 10.35 15 151738 870 90475824
Facial nerve disorder 21.19 10.35 13 151740 592 90476102
Injection site pruritus 21.11 10.35 36 151717 53798 90422896
Pustular psoriasis 21.06 10.35 3 151750 18553 90458141
Decubitus ulcer 21.03 10.35 55 151698 11758 90464936
Atrioventricular block complete 20.98 10.35 49 151704 9762 90466932
Procedural haemorrhage 20.92 10.35 26 151727 3098 90473596
Paranoia 20.87 10.35 58 151695 12850 90463844
Blood pressure diastolic abnormal 20.82 10.35 4 151749 19877 90456817
Polyarthritis 20.75 10.35 3 151750 18347 90458347
Sensitivity to weather change 20.70 10.35 46 151707 8868 90467826
Chest discomfort 20.69 10.35 141 151612 138224 90338470
Palpitations 20.61 10.35 139 151614 136589 90340105
Application site erosion 20.58 10.35 9 151744 200 90476494
Status epilepticus 20.57 10.35 74 151679 18800 90457894
Paraparesis 20.56 10.35 25 151728 2913 90473781
Gaze palsy 20.49 10.35 19 151734 1622 90475072
Paraesthesia oral 20.47 10.35 106 151647 31553 90445141
Muscle tension dysphonia 20.45 10.35 10 151743 289 90476405
Vascular resistance systemic decreased 20.31 10.35 8 151745 135 90476559
Hypotonia 20.14 10.35 53 151700 11373 90465321
Chronic sinusitis 20.00 10.35 86 151667 23716 90452978
Rhinorrhoea 20.00 10.35 78 151675 88238 90388456
Acute lung injury 19.98 10.35 18 151735 1480 90475214
Oesophageal intramural haematoma 19.94 10.35 8 151745 142 90476552
Ileus 19.88 10.35 67 151686 16479 90460215
Intentional product use issue 19.86 10.35 250 151503 216642 90260052
Pupil fixed 19.82 10.35 21 151732 2107 90474587
Product dose omission in error 19.70 10.35 5 151748 20498 90456196
Escherichia infection 19.66 10.35 65 151688 15830 90460864
Perfume sensitivity 19.63 10.35 15 151738 980 90475714
Malnutrition 19.58 10.35 72 151681 18486 90458208
Cataract 19.49 10.35 59 151694 72033 90404661
Posturing 19.41 10.35 12 151741 554 90476140
Normal newborn 19.32 10.35 84 151669 23278 90453416
Ankylosing spondylitis 19.28 10.35 57 151696 13076 90463618
Gastrointestinal scarring 19.27 10.35 11 151742 438 90476256
Decorticate posture 19.09 10.35 10 151743 335 90476359
Analgesic drug level increased 19.08 10.35 24 151729 2895 90473799
Uterine atony 19.01 10.35 10 151743 338 90476356
Application site perspiration 18.96 10.35 5 151748 20 90476674
Oropharyngeal pain 18.95 10.35 114 151639 115073 90361621
Respiratory alkalosis 18.90 10.35 26 151727 3422 90473272
Manufacturing production issue 18.81 10.35 4 151749 4 90476690
Sinus disorder 18.72 10.35 18 151735 34429 90442265
Throat irritation 18.70 10.35 33 151720 48662 90428032
Methaemoglobinaemia 18.67 10.35 28 151725 3987 90472707
Hypermagnesaemia 18.65 10.35 16 151737 1233 90475461
Hypertonia 18.56 10.35 32 151721 5123 90471571
Chest pain 18.51 10.35 401 151352 319244 90157450
Head titubation 18.44 10.35 16 151737 1252 90475442
Abnormal behaviour 18.44 10.35 81 151672 22547 90454147
Gouty tophus 18.40 10.35 9 151744 260 90476434
Therapeutic response unexpected 18.35 10.35 79 151674 21801 90454893
Dyspepsia 18.30 10.35 228 151525 197932 90278762
Myocardial depression 18.18 10.35 12 151741 621 90476073
Vein disorder 18.17 10.35 33 151720 5503 90471191
Blood ethanol increased 18.11 10.35 7 151746 112 90476582
Haematochezia 18.07 10.35 190 151563 70723 90405971
Vitamin K deficiency 18.07 10.35 11 151742 494 90476200
Musculoskeletal disorder 17.90 10.35 7 151746 21762 90454932
Bulimia nervosa 17.89 10.35 11 151742 503 90476191
Eosinophil cationic protein increased 17.65 10.35 6 151747 65 90476629
Hypokalaemia 17.58 10.35 313 151440 130803 90345891
Ileus paralytic 17.58 10.35 31 151722 5054 90471640
Herpes zoster 17.57 10.35 90 151663 94554 90382140
Irregular breathing 17.50 10.35 10 151743 399 90476295
Euphoric mood 17.45 10.35 32 151721 5377 90471317
Gastroduodenal ulcer 17.43 10.35 10 151743 402 90476292
Decerebrate posture 17.31 10.35 7 151746 127 90476567
Poor quality product administered 17.30 10.35 27 151726 3981 90472713
Maternal exposure timing unspecified 17.26 10.35 8 151745 22475 90454219
Sinus bradycardia 17.24 10.35 65 151688 16887 90459807
Oculogyric crisis 17.20 10.35 21 151732 2458 90474236
Exposure to extreme temperature 17.20 10.35 4 151749 8 90476686
Multiple lentigines syndrome 17.17 10.35 8 151745 207 90476487
Gastrointestinal mucosa hyperaemia 17.17 10.35 8 151745 207 90476487
Stupor 17.14 10.35 32 151721 5450 90471244
Myalgia 17.12 10.35 199 151554 174926 90301768
Foreign body 17.10 10.35 21 151732 2473 90474221
Skin maceration 17.06 10.35 8 151745 210 90476484
Bronchiectasis 17.06 10.35 8 151745 22322 90454372
Interstitial lung disease 16.97 10.35 68 151685 76337 90400357
Gastrointestinal haemorrhage 16.91 10.35 228 151525 90020 90386674
Shock haemorrhagic 16.90 10.35 52 151701 12193 90464501
Tryptase increased 16.90 10.35 11 151742 556 90476138
Blood albumin decreased 16.74 10.35 64 151689 16739 90459955
Hypersomnia 16.74 10.35 76 151677 21455 90455239
Quadriparesis 16.73 10.35 21 151732 2528 90474166
Blood creatinine decreased 16.71 10.35 35 151718 6480 90470214
Systemic inflammatory response syndrome 16.71 10.35 35 151718 6481 90470213
Incontinence 16.67 10.35 55 151698 13380 90463314
Toxicologic test abnormal 16.60 10.35 12 151741 720 90475974
Depression 16.58 10.35 380 151373 300221 90176473
Sinus congestion 16.52 10.35 13 151740 27411 90449283
Atrioventricular dissociation 16.49 10.35 8 151745 227 90476467
Myositis 16.44 10.35 10 151743 24118 90452576
Sensory disturbance 16.43 10.35 60 151693 15353 90461341
Mitral valve incompetence 16.40 10.35 78 151675 22446 90454248
Post laminectomy syndrome 16.39 10.35 9 151744 332 90476362
Euthyroid sick syndrome 16.39 10.35 6 151747 82 90476612
Brain herniation 16.36 10.35 27 151726 4173 90472521
Coagulation time prolonged 16.31 10.35 17 151736 1673 90475021
Mean arterial pressure increased 16.28 10.35 5 151748 38 90476656
Injection site bruising 16.24 10.35 40 151713 52267 90424427
Heavy menstrual bleeding 16.24 10.35 7 151746 20523 90456171
Blood pressure immeasurable 16.21 10.35 16 151737 1476 90475218
Pancreatic carcinoma metastatic 16.20 10.35 20 151733 2368 90474326
Increased bronchial secretion 16.19 10.35 19 151734 2134 90474560
Peroneal nerve palsy postoperative 16.18 10.35 3 151750 0 90476694
Tachyphylaxis 16.10 10.35 9 151744 344 90476350
Catatonia 16.08 10.35 33 151720 6023 90470671
Tooth hypoplasia 16.06 10.35 6 151747 87 90476607
Drug ineffective 15.99 10.35 2053 149700 1382245 89094449
Platelet count decreased 15.96 10.35 320 151433 136649 90340045
Transient ischaemic attack 15.92 10.35 30 151723 43146 90433548
Hepatic cytolysis 15.84 10.35 17 151736 30899 90445795
Cardiac massage 15.81 10.35 4 151749 13 90476681
Carcinoembryonic antigen 15.76 10.35 6 151747 92 90476602
Hepatitis 15.68 10.35 63 151690 70676 90406018
Intracranial pressure increased 15.65 10.35 35 151718 6776 90469918
Piloerection 15.60 10.35 11 151742 635 90476059
Karnofsky scale worsened 15.58 10.35 4 151749 14 90476680
Insomnia 15.58 10.35 432 151321 333042 90143652
Bezold-Jarisch reflex 15.53 10.35 5 151748 45 90476649
Haematuria 15.52 10.35 106 151647 34831 90441863
Inflammatory marker increased 15.49 10.35 42 151711 9172 90467522
Anaesthetic complication cardiac 15.44 10.35 5 151748 46 90476648
Carbohydrate antigen 15-3 15.41 10.35 6 151747 98 90476596
Drug specific antibody 15.39 10.35 20 151733 2492 90474202
Paraesthesia 15.38 10.35 311 151442 250015 90226679
Thrombocytopenia 15.37 10.35 458 151295 208267 90268427
Skin exfoliation 15.36 10.35 60 151693 67853 90408841
Colitis 15.36 10.35 182 151571 69760 90406934
Ventricular extrasystoles 15.34 10.35 53 151700 13197 90463497
Pathological fracture 15.22 10.35 43 151710 9617 90467077
Illness 15.19 10.35 78 151675 81891 90394803
Nervous system disorder 15.16 10.35 74 151679 21519 90455175
Tenosynovitis 15.11 10.35 3 151750 14564 90462130
Feeling cold 15.10 10.35 88 151665 27377 90449317
Accidental exposure to product 15.10 10.35 122 151631 42244 90434450
Dyspnoea exertional 15.02 10.35 66 151687 72222 90404472
Areflexia 14.93 10.35 24 151729 3629 90473065
Blood pressure systolic abnormal 14.85 10.35 7 151746 19471 90457223
Moaning 14.84 10.35 13 151740 1030 90475664
Chorea 14.84 10.35 18 151735 2092 90474602
Eructation 14.82 10.35 46 151707 10836 90465858
Rash pruritic 14.80 10.35 79 151674 82135 90394559
Hyperdynamic left ventricle 14.80 10.35 8 151745 286 90476408
Tumour pain 14.77 10.35 17 151736 1870 90474824
Intervertebral disc compression 14.75 10.35 14 151739 1231 90475463
Multiple sclerosis relapse 14.72 10.35 42 151711 52263 90424431
Compression fracture 14.72 10.35 40 151713 8749 90467945
Cranial nerve disorder 14.71 10.35 11 151742 696 90475998
Progressive multifocal leukoencephalopathy 14.70 10.35 4 151749 15651 90461043
Hyperbilirubinaemia 14.65 10.35 54 151699 13882 90462812
Alanine aminotransferase increased 14.64 10.35 279 151474 118059 90358635
Persistent depressive disorder 14.63 10.35 14 151739 1243 90475451
Intestinal infarction 14.59 10.35 13 151740 1054 90475640
Metastases to meninges 14.53 10.35 24 151729 3711 90472983
Drug eruption 14.51 10.35 23 151730 35384 90441310
Complex regional pain syndrome 14.50 10.35 20 151733 2639 90474055
Dermal absorption impaired 14.48 10.35 5 151748 57 90476637
Intestinal obstruction 14.38 10.35 109 151644 37022 90439672
Pulmonary hypertension 14.37 10.35 121 151632 42402 90434292
Musculoskeletal pain 14.36 10.35 201 151552 171050 90305644
Product substitution issue 14.32 10.35 64 151689 17944 90458750
Oxygen saturation immeasurable 14.28 10.35 4 151749 21 90476673
Diabetes mellitus 14.24 10.35 58 151695 64817 90411877
Endometriosis 14.24 10.35 32 151721 6216 90470478
Intentional dose omission 14.17 10.35 6 151747 17777 90458917
Yawning 14.13 10.35 13 151740 1099 90475595
Nerve stimulation test abnormal 14.11 10.35 3 151750 3 90476691
Labelled drug-drug interaction medication error 14.08 10.35 55 151698 14527 90462167
Movement disorder 14.07 10.35 90 151663 28929 90447765
Anion gap 13.83 10.35 13 151740 1129 90475565
Periorbital cellulitis 13.78 10.35 11 151742 766 90475928
Eye pruritus 13.75 10.35 17 151736 29010 90447684
Metastases to lymph nodes 13.75 10.35 47 151706 11642 90465052
Dysphemia 13.70 10.35 21 151732 3049 90473645
Procedural vomiting 13.61 10.35 11 151742 780 90475914
Dry skin 13.54 10.35 89 151664 87984 90388710
Extradural haematoma 13.51 10.35 17 151736 2051 90474643
Muscle spasticity 13.50 10.35 24 151729 35298 90441396
Intestinal ischaemia 13.47 10.35 39 151714 8844 90467850
Transcranial electrical motor evoked potential monitoring abnormal 13.43 10.35 4 151749 27 90476667
Abdominal pain 13.41 10.35 800 150953 394921 90081773
Metastatic malignant melanoma 13.34 10.35 15 151738 1609 90475085
Pain 13.33 10.35 1463 150290 994878 89481816
Burkholderia test positive 13.30 10.35 7 151746 237 90476457
Blood creatinine increased 13.22 10.35 241 151512 101145 90375549
Product administered to patient of inappropriate age 13.13 10.35 26 151727 4627 90472067
Pneumonia 13.11 10.35 906 150847 637153 89839541
Non-cardiogenic pulmonary oedema 13.07 10.35 13 151740 1211 90475483
Bone pain 13.05 10.35 160 151593 61823 90414871
Air embolism 13.03 10.35 8 151745 365 90476329
Sinus arrest 13.01 10.35 17 151736 2129 90474565
Panniculitis 13.01 10.35 4 151749 14454 90462240
Small intestinal obstruction 12.98 10.35 70 151683 21164 90455530
Paronychia 12.97 10.35 36 151717 7970 90468724
Fungal infection 12.95 10.35 33 151720 42628 90434066
Rhinitis allergic 12.84 10.35 6 151747 16779 90459915
Product formulation issue 12.83 10.35 10 151743 673 90476021
Middle insomnia 12.80 10.35 6 151747 16745 90459949
Injection site rash 12.71 10.35 13 151740 24160 90452534
Visceral congestion 12.70 10.35 8 151745 382 90476312
Brachial plexopathy 12.68 10.35 7 151746 261 90476433
Pneumocephalus 12.66 10.35 7 151746 262 90476432
Neonatal hypotension 12.64 10.35 6 151747 162 90476532
Acute pulmonary oedema 12.59 10.35 40 151713 9540 90467154
Hyperthermia 12.55 10.35 42 151711 10293 90466401
Eczema 12.42 10.35 46 151707 52824 90423870
Laryngeal obstruction 12.40 10.35 5 151748 90 90476604
Therapeutic response shortened 12.38 10.35 12 151741 22867 90453827
Disturbance in attention 12.37 10.35 127 151626 46982 90429712
Impaired driving ability 12.36 10.35 27 151726 5146 90471548
Gamma-glutamyltransferase 12.33 10.35 4 151749 37 90476657
Injection site warmth 12.30 10.35 7 151746 17508 90459186
Diaphragmatic spasm 12.30 10.35 3 151750 8 90476686
Autoimmune pericarditis 12.25 10.35 5 151748 93 90476601
Implant site extravasation 12.22 10.35 9 151744 556 90476138
Vasoplegia syndrome 12.21 10.35 19 151734 2795 90473899
Troponin I increased 12.14 10.35 18 151735 2537 90474157
Diabetic retinal oedema 12.12 10.35 8 151745 414 90476280
Laryngeal stenosis 12.09 10.35 13 151740 1326 90475368
End-tidal CO2 increased 12.04 10.35 3 151750 9 90476685
Disability 12.00 10.35 32 151721 40713 90435981
Nephrolithiasis 12.00 10.35 42 151711 49043 90427651
Dyspnoea 11.98 10.35 1292 150461 879663 89597031
Gastrointestinal vascular malformation 11.96 10.35 4 151749 41 90476653
Pancreatic carcinoma 11.96 10.35 36 151717 8341 90468353
Amnesia 11.92 10.35 120 151633 108385 90368309
Acute chest syndrome 11.90 10.35 12 151741 1136 90475558
Breast cancer female 11.90 10.35 5 151748 14881 90461813
Metastases to spine 11.89 10.35 22 151731 3721 90472973
Cerebrovascular accident 11.83 10.35 141 151612 123392 90353302
Pancreatic enzymes abnormal 11.80 10.35 3 151750 10 90476684
Metastatic gastric cancer 11.79 10.35 6 151747 189 90476505
Premature separation of placenta 11.75 10.35 17 151736 2345 90474349
Electrolyte imbalance 11.73 10.35 74 151679 23671 90453023
Blood phosphorus decreased 11.72 10.35 26 151727 5008 90471686
Muscle twitching 11.70 10.35 75 151678 24127 90452567
Hypoglycaemia 11.69 10.35 173 151580 69675 90407019
Premature baby 11.69 10.35 77 151676 25000 90451694
Fracture 11.67 10.35 70 151683 22006 90454688
Chemical peritonitis 11.65 10.35 5 151748 106 90476588
Embolic cerebral infarction 11.65 10.35 9 151744 598 90476096
Sepsis syndrome 11.64 10.35 11 151742 962 90475732
Self-medication 11.61 10.35 20 151733 3200 90473494
Cardiovascular insufficiency 11.59 10.35 14 151739 1621 90475073
Concomitant disease aggravated 11.58 10.35 44 151709 11474 90465220
Metabolic encephalopathy 11.58 10.35 31 151722 6721 90469973
Sequestrectomy 11.56 10.35 10 151743 779 90475915
Chest expansion decreased 11.55 10.35 4 151749 46 90476648
Malaise 11.55 10.35 835 150918 585151 89891543
Haemoperitoneum 11.54 10.35 21 151732 3507 90473187
Osteonecrosis of jaw 11.53 10.35 108 151645 38995 90437699
Tremor 11.51 10.35 337 151416 152836 90323858
Hydrocephalus 11.50 10.35 29 151724 6065 90470629
Acidosis 11.47 10.35 47 151706 12689 90464005
Dysaesthesia pharynx 11.43 10.35 6 151747 202 90476492
Skin lesion 11.42 10.35 104 151649 37261 90439433
Autoimmune lung disease 11.39 10.35 5 151748 112 90476582
Intestinal gangrene 11.37 10.35 3 151750 12 90476682
Metastatic neoplasm 11.36 10.35 25 151728 4790 90471904
Large intestinal obstruction 11.32 10.35 18 151735 2696 90473998
Lagophthalmos 11.31 10.35 8 151745 464 90476230
Tooth loss 11.30 10.35 33 151720 7521 90469173
Echolalia 11.27 10.35 7 151746 326 90476368
Hypernatraemia 11.27 10.35 38 151715 9349 90467345
Electrocardiogram QT prolonged 11.18 10.35 177 151576 72279 90404415
Application site laceration 11.18 10.35 3 151750 13 90476681
Oral cavity fistula 11.18 10.35 9 151744 635 90476059
Aspartate aminotransferase increased 11.17 10.35 238 151515 102699 90373995
Foetal heart rate decreased 11.16 10.35 6 151747 212 90476482
Frequent bowel movements 11.15 10.35 145 151608 56790 90419904
Anastomotic leak 11.14 10.35 9 151744 638 90476056
Procedural headache 11.14 10.35 6 151747 213 90476481
Limb discomfort 11.13 10.35 30 151723 38030 90438664
Prinzmetal angina 10.97 10.35 11 151742 1034 90475660
Cardiovascular symptom 10.96 10.35 5 151748 123 90476571
Spondylitis 10.95 10.35 5 151748 14173 90462521
Muscular weakness 10.90 10.35 263 151490 206403 90270291
Hepatic function abnormal 10.86 10.35 122 151631 46166 90430528
Neuralgia 10.84 10.35 90 151663 31410 90445284
Syphilis 10.84 10.35 6 151747 225 90476469
Incoherent 10.80 10.35 25 151728 4952 90471742
Nerve block 10.77 10.35 10 151743 855 90475839
Hemianopia homonymous 10.77 10.35 10 151743 855 90475839
Long QT syndrome 10.72 10.35 22 151731 4015 90472679
Manipulation 10.71 10.35 4 151749 58 90476636
Ventricular dysfunction 10.71 10.35 21 151732 3710 90472984
Toxic epidermal necrolysis 10.70 10.35 92 151661 32436 90444258
Sputum discoloured 10.69 10.35 11 151742 20380 90456314
Monoparesis 10.69 10.35 15 151738 2012 90474682
Protrusion tongue 10.68 10.35 7 151746 358 90476336
Heart rate increased 10.68 10.35 256 151497 112646 90364048
Gingival cancer 10.67 10.35 3 151750 16 90476678
Mean cell haemoglobin decreased 10.64 10.35 27 151726 5668 90471026
Osteomyelitis chronic 10.63 10.35 8 151745 511 90476183
Gastrointestinal hypomotility 10.62 10.35 12 151741 1293 90475401
Asphyxia 10.59 10.35 31 151722 7072 90469622
Ovarian cancer 10.54 10.35 30 151723 6737 90469957
Phaeochromocytoma crisis 10.54 10.35 7 151746 366 90476328
Impaired quality of life 10.50 10.35 14 151739 23130 90453564
Infusion site haemorrhage 10.47 10.35 26 151727 5385 90471309
Gallbladder oedema 10.46 10.35 6 151747 241 90476453
Bile duct stone 10.46 10.35 22 151731 4085 90472609
Alanine aminotransferase decreased 10.46 10.35 10 151743 887 90475807
Paroxysmal arrhythmia 10.41 10.35 4 151749 63 90476631
Head and neck cancer 10.41 10.35 4 151749 63 90476631
Subcutaneous emphysema 10.40 10.35 11 151742 1101 90475593
Migraine 10.40 10.35 241 151512 190151 90286543
Tuberculosis 10.38 10.35 4 151749 12545 90464149
Hypnotherapy 10.37 10.35 3 151750 18 90476676
Obstetric procedure complication 10.37 10.35 3 151750 18 90476676

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug abuse 12842.97 10.93 6145 116103 98626 42400461
Toxicity to various agents 3403.53 10.93 3708 118540 225428 42273659
Respiratory arrest 1338.37 10.93 897 121351 27527 42471560
Cardiac arrest 1028.25 10.93 1410 120838 107910 42391177
Overdose 1020.79 10.93 1378 120870 103886 42395201
Cardio-respiratory arrest 860.33 10.93 947 121301 57689 42441398
Serotonin syndrome 740.43 10.93 605 121643 25240 42473847
Respiratory depression 718.40 10.93 523 121725 18345 42480742
Prescription drug used without a prescription 683.42 10.93 267 121981 2463 42496624
Product adhesion issue 599.35 10.93 215 122033 1524 42497563
Incorrect route of product administration 595.46 10.93 520 121728 23785 42475302
Drug withdrawal syndrome 558.21 10.93 476 121772 21073 42478014
Accidental overdose 555.39 10.93 535 121713 27795 42471292
Unresponsive to stimuli 393.86 10.93 468 121780 30935 42468152
Drug dependence 341.03 10.93 419 121829 28675 42470412
Hyperthermia malignant 301.63 10.93 149 122099 2509 42496578
Depressed level of consciousness 296.33 10.93 510 121738 47460 42451627
Intentional product misuse 293.17 10.93 587 121661 61313 42437774
Miosis 273.02 10.93 259 121989 13187 42485900
Anaphylactic reaction 246.56 10.93 441 121807 42302 42456785
Hyperaesthesia 244.82 10.93 173 122075 5779 42493308
Death 220.54 10.93 2188 120060 468997 42030090
Pulmonary oedema 214.70 10.93 473 121775 52799 42446288
Inadequate analgesia 200.39 10.93 121 122127 3076 42496011
Drug use disorder 198.36 10.93 193 122055 10140 42488947
Amnestic disorder 176.37 10.93 56 122192 257 42498830
Withdrawal syndrome 175.04 10.93 214 122034 14561 42484526
Off label use 171.12 10.93 1103 121145 637232 41861855
Delirium 170.94 10.93 429 121819 52090 42446997
Delayed recovery from anaesthesia 170.83 10.93 78 122170 1091 42497996
Brain oedema 158.11 10.93 214 122034 16113 42482974
Product quality issue 136.00 10.93 209 122039 17673 42481414
Pruritus 134.90 10.93 208 122040 188563 42310524
Drug interaction 134.21 10.93 1260 120988 265739 42233348
Neuromuscular block prolonged 128.79 10.93 53 122195 566 42498521
Apnoea 128.24 10.93 134 122114 7669 42491418
Hypotension 126.57 10.93 1210 121038 256421 42242666
Injury 121.96 10.93 225 122023 22091 42476996
Respiratory acidosis 121.04 10.93 118 122130 6213 42492874
Headache 119.80 10.93 324 121924 239045 42260042
Rash 118.52 10.93 403 121845 276551 42222536
Anaesthetic complication 117.57 10.93 65 122183 1392 42497695
Product dose omission issue 117.20 10.93 163 122085 154202 42344885
Myoclonus 114.02 10.93 188 122060 16877 42482210
Arthralgia 110.21 10.93 268 121980 204970 42294117
COVID-19 105.58 10.93 106 122142 115842 42383245
Diarrhoea 104.72 10.93 834 121414 460015 42039072
Fear 103.55 10.93 142 122106 10823 42488264
Bradypnoea 103.53 10.93 92 122156 4301 42494786
Somnolence 102.80 10.93 725 121523 140380 42358707
Cough 101.69 10.93 225 122023 177878 42321209
Counterfeit product administered 99.99 10.93 36 122212 258 42498829
Wrong technique in product usage process 92.54 10.93 301 121947 42334 42456753
Hypoxia 92.38 10.93 421 121827 69365 42429722
Neoplasm progression 92.34 10.93 235 122013 28765 42470322
Propofol infusion syndrome 92.28 10.93 52 122196 1157 42497930
Asthma 91.78 10.93 32 122216 62282 42436805
Brain injury 90.86 10.93 111 122137 7544 42491543
Hypercapnia 86.20 10.93 91 122157 5270 42493817
Agitation 85.87 10.93 389 121859 63925 42435162
Accidental exposure to product by child 84.76 10.93 54 122194 1513 42497574
Bradycardia 84.52 10.93 475 121773 85009 42414078
Substance use 81.67 10.93 55 122193 1696 42497391
Procedural hypotension 81.63 10.93 45 122203 958 42498129
Completed suicide 81.26 10.93 514 121734 95951 42403136
Fatigue 81.12 10.93 829 121419 434812 42064275
Pulseless electrical activity 80.79 10.93 110 122138 8327 42490760
Sedation complication 80.73 10.93 67 122181 2852 42496235
Inspiratory capacity decreased 79.78 10.93 67 122181 2900 42496187
Anaphylactic shock 79.53 10.93 195 122053 23322 42475765
Intensive care unit acquired weakness 79.14 10.93 48 122200 1230 42497857
Weight increased 78.97 10.93 117 122131 107866 42391221
Muscle rigidity 78.08 10.93 131 122117 11928 42487159
Anhedonia 76.80 10.93 102 122146 7538 42491549
Non-cardiogenic pulmonary oedema 76.24 10.93 42 122206 893 42498194
Impaired driving ability 75.91 10.93 65 122183 2890 42496197
Drug diversion 74.11 10.93 42 122206 945 42498142
Opiates positive 72.16 10.93 34 122214 513 42498574
Respiratory rate decreased 72.05 10.93 63 122185 2882 42496205
Emotional distress 71.81 10.93 149 122099 15944 42483143
Treatment failure 71.03 10.93 46 122202 62578 42436509
Tachycardia 69.86 10.93 513 121735 100574 42398513
Peripheral swelling 69.79 10.93 94 122154 90176 42408911
Renal injury 68.59 10.93 125 122123 12155 42486932
Cyanosis 68.05 10.93 140 122108 14891 42484196
Nasopharyngitis 67.47 10.93 85 122163 83911 42415176
Narcotic bowel syndrome 65.72 10.93 22 122226 123 42498964
Dyspnoea 65.46 10.93 886 121362 441735 42057352
Procedural complication 63.23 10.93 69 122179 4150 42494937
Product counterfeit 62.94 10.93 22 122226 143 42498944
Myalgia 62.85 10.93 112 122136 95968 42403119
Post procedural complication 62.67 10.93 122 122126 12468 42486619
Tachypnoea 62.29 10.93 169 122079 21493 42477594
Negative pressure pulmonary oedema 62.02 10.93 32 122216 593 42498494
Coma 61.38 10.93 310 121938 53244 42445843
Cardiac failure congestive 61.37 10.93 94 122154 85508 42413579
Dyspnoea exertional 60.85 10.93 34 122214 50114 42448973
Product use in unapproved indication 60.80 10.93 297 121951 184159 42314928
Oxygen saturation decreased 60.35 10.93 354 121894 64333 42434754
Endotracheal intubation 58.65 10.93 63 122185 3722 42495365
Blood cholesterol increased 58.07 10.93 5 122243 26736 42472351
Laryngospasm 57.85 10.93 47 122201 1941 42497146
Sinusitis 57.47 10.93 32 122216 47260 42451827
Postmortem blood drug level abnormal 57.30 10.93 26 122222 358 42498729
Febrile neutropenia 56.14 10.93 308 121940 185395 42313692
Diabetes insipidus 56.13 10.93 61 122187 3652 42495435
Myelosuppression 55.86 10.93 23 122225 40438 42458649
Respiratory failure 55.58 10.93 587 121661 127545 42371542
Trigemino-cardiac reflex 54.99 10.93 25 122223 346 42498741
Pain in extremity 54.68 10.93 234 122014 150370 42348717
Pelvic pain 53.68 10.93 56 122192 3198 42495889
Injection site pain 53.54 10.93 52 122196 57746 42441341
Anion gap 53.43 10.93 32 122216 801 42498286
Metabolic acidosis 53.12 10.93 291 121957 51567 42447520
Malignant catatonia 52.88 10.93 26 122222 433 42498654
Diabetes mellitus 52.33 10.93 57 122191 60030 42439057
Spinal muscular atrophy 52.25 10.93 25 122223 391 42498696
Psoriasis 52.06 10.93 38 122210 48566 42450521
Malignant neoplasm progression 51.99 10.93 507 121741 107893 42391194
Dizziness 51.91 10.93 461 121787 248793 42250294
Brain death 51.47 10.93 53 122195 2981 42496106
Compartment syndrome 51.41 10.93 55 122193 3234 42495853
Bronchospasm 51.40 10.93 114 122134 12771 42486316
Blood glucose increased 50.86 10.93 83 122165 73616 42425471
Chest discomfort 50.43 10.93 65 122183 63551 42435536
Dry skin 50.22 10.93 39 122209 48299 42450788
Loss of personal independence in daily activities 49.50 10.93 42 122206 49774 42449313
Toxic leukoencephalopathy 49.43 10.93 29 122219 698 42498389
Coronary artery disease 48.99 10.93 49 122199 53671 42445416
Blood pressure decreased 48.58 10.93 310 121938 58022 42441065
Hypoxic-ischaemic encephalopathy 48.56 10.93 67 122181 5135 42493952
Confusional state 47.44 10.93 709 121539 166888 42332199
Infusion related reaction 47.31 10.93 63 122185 60743 42438344
Abdominal discomfort 47.19 10.93 90 122158 75165 42423922
Product prescribing error 46.77 10.93 173 122075 25939 42473148
Clonus 46.65 10.93 54 122194 3466 42495621
Hyperthermia 46.54 10.93 108 122140 12466 42486621
Exposure to toxic agent 46.04 10.93 64 122184 4940 42494147
Product complaint 45.64 10.93 70 122178 5907 42493180
Full blood count abnormal 44.57 10.93 15 122233 29861 42469226
Resuscitation 44.56 10.93 39 122209 1786 42497301
Drug tolerance 44.49 10.93 51 122197 3239 42495848
Rheumatoid arthritis 44.40 10.93 34 122214 42406 42456681
Stress cardiomyopathy 44.29 10.93 47 122201 2738 42496349
Syncope 44.22 10.93 142 122106 99264 42399823
Neuropathy peripheral 43.58 10.93 148 122100 101705 42397382
Haemodynamic instability 43.38 10.93 105 122143 12452 42486635
Eczema 42.98 10.93 22 122226 34064 42465023
Poisoning 42.58 10.93 115 122133 14584 42484503
Arthritis 42.37 10.93 35 122213 42030 42457057
Cytomegalovirus infection 42.02 10.93 20 122228 32286 42466801
Influenza 41.99 10.93 71 122177 62104 42436983
Myocardial infarction 41.80 10.93 198 122050 123811 42375276
Drug detoxification 41.55 10.93 21 122227 372 42498715
Malaise 41.29 10.93 399 121849 211757 42287330
Amphetamines positive 40.70 10.93 17 122231 189 42498898
Drug screen positive 39.76 10.93 54 122194 4077 42495010
Unevaluable event 39.65 10.93 199 122049 34089 42464998
Pulmonary congestion 39.63 10.93 117 122131 15613 42483474
Mental status changes 39.61 10.93 231 122017 41884 42457203
Cerebrovascular accident 39.02 10.93 145 122103 97015 42402072
Tryptase increased 38.94 10.93 19 122229 311 42498776
Acute lung injury 38.89 10.93 34 122214 1555 42497532
Accidental poisoning 38.47 10.93 31 122217 1265 42497822
Airway complication of anaesthesia 38.06 10.93 16 122232 181 42498906
Drug withdrawal syndrome neonatal 38.01 10.93 55 122193 4406 42494681
Transient ischaemic attack 37.96 10.93 25 122223 33714 42465373
Therapy naive 37.79 10.93 11 122237 35 42499052
Skin exfoliation 37.77 10.93 38 122210 41515 42457572
Drug resistance 37.69 10.93 26 122222 34222 42464865
Upper airway obstruction 37.18 10.93 25 122223 769 42498318
Neutropenia 37.16 10.93 379 121869 199052 42300035
Rectal haemorrhage 36.98 10.93 53 122195 49553 42449534
Nephrolithiasis 36.65 10.93 31 122217 36799 42462288
Pyrexia 36.65 10.93 856 121392 393186 42105901
Cardiac failure 36.37 10.93 170 122078 106686 42392401
Increased bronchial secretion 36.26 10.93 39 122209 2307 42496780
Sleep disorder 36.23 10.93 51 122197 48044 42451043
Palpitations 36.18 10.93 56 122192 50741 42448346
Terminal insomnia 36.15 10.93 26 122222 893 42498194
Sleep disorder due to a general medical condition 35.96 10.93 4 122244 17449 42481638
Recurrence of neuromuscular blockade 35.81 10.93 17 122231 261 42498826
Oedema peripheral 35.67 10.93 236 122012 135840 42363247
Hypoventilation 35.54 10.93 49 122199 3753 42495334
Hyperlipidaemia 35.40 10.93 9 122239 21507 42477580
Condition aggravated 35.22 10.93 531 121717 260223 42238864
Basal cell carcinoma 34.64 10.93 11 122237 22722 42476365
Anterograde amnesia 34.58 10.93 17 122231 283 42498804
Seizure like phenomena 34.19 10.93 27 122221 1070 42498017
Disorientation 33.83 10.93 199 122049 36190 42462897
Diabetic ketoacidosis 33.77 10.93 11 122237 22356 42476731
Herpes zoster 33.71 10.93 37 122211 38840 42460247
Angina pectoris 33.59 10.93 27 122221 32869 42466218
Upper respiratory tract infection 33.51 10.93 43 122205 42130 42456957
Thrombosis 33.23 10.93 94 122154 68417 42430670
Urinary tract infection 33.17 10.93 159 122089 99125 42399962
Sinus tachycardia 33.02 10.93 132 122116 20521 42478566
Piloerection 32.78 10.93 16 122232 262 42498825
Acidosis 32.54 10.93 93 122155 12186 42486901
Blood pressure increased 32.47 10.93 166 122082 101762 42397325
Eosinophilia 32.36 10.93 28 122220 32871 42466216
Intestinal pseudo-obstruction 32.27 10.93 36 122212 2219 42496868
Acute respiratory distress syndrome 32.21 10.93 171 122077 29937 42469150
Vision blurred 32.12 10.93 66 122182 53633 42445454
Post procedural hypotension 31.94 10.93 11 122237 68 42499019
Lower respiratory tract infection 31.74 10.93 43 122205 41163 42457924
Postoperative ileus 31.49 10.93 22 122226 721 42498366
Pneumococcal sepsis 31.40 10.93 29 122219 1426 42497661
Substance abuse 31.34 10.93 75 122173 8830 42490257
Stoma closure 31.23 10.93 16 122232 292 42498795
Therapeutic product effect incomplete 31.08 10.93 102 122146 70837 42428250
Tachyphylaxis 31.01 10.93 13 122235 146 42498941
Autonomic nervous system imbalance 30.40 10.93 41 122207 3075 42496012
Joint swelling 30.36 10.93 97 122151 67925 42431162
Therapeutic product effect increased 30.35 10.93 22 122226 765 42498322
Coma scale abnormal 30.09 10.93 50 122198 4515 42494572
Migraine 29.73 10.93 18 122230 25396 42473691
Gait disturbance 29.32 10.93 163 122085 97837 42401250
Agranulocytosis 28.98 10.93 27 122221 30585 42468502
Therapy interrupted 28.59 10.93 14 122234 22236 42476851
Oxygen saturation immeasurable 28.58 10.93 9 122239 40 42499047
Haemoglobin decreased 28.41 10.93 243 122005 132228 42366859
Intentional product use issue 28.32 10.93 323 121925 71510 42427577
Polyneuropathy in malignant disease 28.23 10.93 16 122232 360 42498727
Coma blister 28.22 10.93 10 122238 68 42499019
Therapeutic response shortened 28.20 10.93 3 122245 13551 42485536
Drug ineffective 28.18 10.93 1500 120748 628697 41870390
Blood pressure measurement 28.14 10.93 13 122235 187 42498900
Allodynia 27.97 10.93 24 122224 1070 42498017
Drug abuser 27.87 10.93 42 122206 3489 42495598
Vasculitis 27.85 10.93 9 122239 18385 42480702
Constipation 27.80 10.93 635 121613 161656 42337431
Accidental death 27.72 10.93 39 122209 3044 42496043
White blood cell count decreased 27.66 10.93 194 122054 110202 42388885
Swelling 27.59 10.93 74 122174 54811 42444276
Chronic obstructive pulmonary disease 27.47 10.93 91 122157 63023 42436064
Atrial fibrillation 27.35 10.93 262 121986 139331 42359756
Disease recurrence 27.13 10.93 27 122221 29651 42469436
Motor neurone disease 27.13 10.93 18 122230 541 42498546
Leukoencephalopathy 27.12 10.93 50 122198 4904 42494183
End stage renal disease 27.10 10.93 7 122241 16551 42482536
Acute motor axonal neuropathy 27.05 10.93 10 122238 78 42499009
Myocardial stunning 27.04 10.93 7 122241 12 42499075
Pain 26.96 10.93 905 121343 243943 42255144
Gastrointestinal haemorrhage 26.87 10.93 167 122081 97559 42401528
Wheezing 26.69 10.93 75 122173 54706 42444381
Hypoperfusion 26.51 10.93 26 122222 1379 42497708
Appendicitis 26.44 10.93 13 122235 20600 42478487
Productive cough 26.32 10.93 69 122179 51498 42447589
Type 2 diabetes mellitus 26.31 10.93 10 122238 18461 42480626
Hypoglycaemia 26.26 10.93 86 122162 59768 42439319
Injection site swelling 26.24 10.93 8 122240 16965 42482122
Accidental exposure to product 26.20 10.93 122 122126 20271 42478816
Foetal exposure during delivery 26.12 10.93 11 122237 125 42498962
Vasoplegia syndrome 26 10.93 35 122213 2620 42496467
Breakthrough pain 25.92 10.93 18 122230 584 42498503
Pulmonary embolism 25.83 10.93 219 122029 119393 42379694
Circulatory collapse 25.80 10.93 135 122113 23501 42475586
Thermophobia 25.68 10.93 9 122239 59 42499028
Suicide attempt 25.64 10.93 59 122189 46041 42453046
Gynaecomastia 25.59 10.93 3 122245 12564 42486523
Ventricular arrhythmia 25.54 10.93 56 122192 6223 42492864
Application site rash 25.52 10.93 22 122226 987 42498100
Paraesthesia 25.50 10.93 116 122132 73343 42425744
Antemortem blood drug level abnormal 24.94 10.93 9 122239 65 42499022
Arteriospasm coronary 24.91 10.93 47 122201 4691 42494396
Motor dysfunction 24.88 10.93 65 122183 8081 42491006
Anaesthetic complication neurological 24.86 10.93 19 122229 717 42498370
Psoriatic arthropathy 24.86 10.93 21 122227 24946 42474141
Musculoskeletal stiffness 24.65 10.93 84 122164 57681 42441406
Systolic anterior motion of mitral valve 24.64 10.93 8 122240 40 42499047
Presyncope 24.63 10.93 17 122231 22370 42476717
Pneumonia aspiration 24.36 10.93 235 122013 49843 42449244
Paraplegia 24.31 10.93 38 122210 3259 42495828
Endotracheal intubation complication 24.27 10.93 15 122233 398 42498689
Tubulointerstitial nephritis 24.21 10.93 33 122215 31515 42467572
Gastrointestinal disorder 24.14 10.93 62 122186 46591 42452496
Drug screen negative 24.13 10.93 12 122236 205 42498882
Cachexia 24.07 10.93 64 122184 8040 42491047
Blood pressure fluctuation 24.01 10.93 25 122223 26883 42472204
Lymphadenectomy 23.97 10.93 16 122232 486 42498601
Micturition urgency 23.84 10.93 3 122245 11895 42487192
Hypogammaglobulinaemia 23.82 10.93 3 122245 11888 42487199
Drug-induced liver injury 23.78 10.93 46 122202 38227 42460860
Postmortem blood drug level 23.70 10.93 11 122237 160 42498927
Airway peak pressure increased 23.64 10.93 11 122237 161 42498926
Pneumonitis chemical 23.57 10.93 13 122235 277 42498810
Posthaemorrhagic hydrocephalus 23.57 10.93 10 122238 116 42498971
Viral infection 23.53 10.93 18 122230 22465 42476622
Bronchitis 23.45 10.93 64 122184 47137 42451950
Blood ethanol 23.03 10.93 9 122239 83 42499004
Blood uric acid increased 22.85 10.93 8 122240 15539 42483548
Melaena 22.85 10.93 48 122200 38698 42460389
Erythema 22.69 10.93 201 122047 108592 42390495
Eye pruritus 22.57 10.93 3 122245 11409 42487678
Fall 22.43 10.93 507 121741 234013 42265074
Kounis syndrome 22.35 10.93 37 122211 3331 42495756
Hypogonadism 22.20 10.93 31 122217 2403 42496684
Electrocardiogram ST segment elevation 21.97 10.93 51 122197 5888 42493199
Locked-in syndrome 21.95 10.93 14 122234 393 42498694
Thrombocytopenia 21.88 10.93 399 121849 189880 42309207
Methaemoglobinaemia 21.81 10.93 50 122198 5724 42493363
Visual impairment 21.77 10.93 58 122190 43055 42456032
Epistaxis 21.75 10.93 108 122140 66718 42432369
Sciatic nerve neuropathy 21.68 10.93 8 122240 62 42499025
Hyperhidrosis 21.48 10.93 372 121876 90140 42408947
Haematotoxicity 21.46 10.93 3 122245 10982 42488105
Ventricular tachycardia 21.34 10.93 154 122094 30006 42469081
Chest pain 21.34 10.93 277 121971 139253 42359834
Apnoeic attack 21.20 10.93 15 122233 502 42498585
Application site hypersensitivity 21.09 10.93 9 122239 106 42498981
Metabolic disorder 20.97 10.93 44 122204 4744 42494343
Myasthenia gravis 20.97 10.93 10 122238 16127 42482960
Swollen tongue 20.97 10.93 18 122230 21213 42477874
Leukopenia 20.92 10.93 127 122121 74619 42424468
Influenza like illness 20.91 10.93 37 122211 31803 42467284
Burkholderia test positive 20.88 10.93 20 122228 1030 42498057
Acute myeloid leukaemia 20.63 10.93 20 122228 22236 42476851
Injection site bruising 20.61 10.93 4 122244 11521 42487566
Bacterial infection 20.56 10.93 30 122218 27849 42471238
Nasal congestion 20.55 10.93 33 122215 29468 42469619
Local anaesthetic systemic toxicity 20.54 10.93 29 122219 2271 42496816
Fluid retention 20.53 10.93 37 122211 31582 42467505
Sinus arrest 20.47 10.93 28 122220 2128 42496959
Nightmare 20.40 10.93 25 122223 24987 42474100
Pulmonary fibrosis 20.39 10.93 28 122220 26653 42472434
Oculocardiac reflex 20.37 10.93 9 122239 116 42498971
Rash pruritic 20.35 10.93 41 122207 33562 42465525
Misleading laboratory test result 20.18 10.93 6 122242 21 42499066
Lower respiratory tract infection bacterial 20.02 10.93 15 122233 549 42498538
Anaemia 19.97 10.93 632 121616 279646 42219441
Accident 19.97 10.93 52 122196 6451 42492636
Hospitalisation 19.92 10.93 128 122120 74202 42424885
Gout 19.91 10.93 31 122217 28024 42471063
Pulse absent 19.85 10.93 51 122197 6276 42492811
Hypercapnic coma 19.84 10.93 10 122238 176 42498911
Cardiac murmur 19.79 10.93 6 122242 12769 42486318
Coma neonatal 19.75 10.93 6 122242 23 42499064
Hypotonic-hyporesponsive episode 19.75 10.93 6 122242 23 42499064
Visual acuity reduced 19.74 10.93 13 122235 17537 42481550
Cytomegalovirus infection reactivation 19.74 10.93 4 122244 11174 42487913
Therapy partial responder 19.74 10.93 17 122231 20004 42479083
Rhinitis 19.72 10.93 5 122243 11972 42487115
Cytopenia 19.63 10.93 13 122235 17484 42481603
Tinnitus 19.57 10.93 33 122215 28905 42470182
Bone marrow failure 19.51 10.93 41 122207 33052 42466035
Bronchial disorder 19.46 10.93 22 122226 1376 42497711
Disease complication 19.41 10.93 33 122215 3037 42496050
Oropharyngeal pain 19.40 10.93 60 122188 42450 42456637
Metastases to bone 19.32 10.93 89 122159 14720 42484367
Application site reaction 19.24 10.93 13 122235 403 42498684
Blood phosphorus increased 19.19 10.93 6 122242 12519 42486568
Tuberculosis 19.17 10.93 3 122245 10096 42488991
Platelet count decreased 19.09 10.93 281 121967 138300 42360787
Pancytopenia 19.03 10.93 231 122017 117512 42381575
Urinary retention 19.03 10.93 195 122053 42019 42457068
Environmental exposure 19.00 10.93 11 122237 258 42498829
Application site pruritus 18.92 10.93 23 122225 1555 42497532
Gastrooesophageal reflux disease 18.85 10.93 66 122182 44957 42454130
Stupor 18.76 10.93 33 122215 3120 42495967
Neuromuscular blockade 18.75 10.93 12 122236 339 42498748
Red blood cell sedimentation rate increased 18.72 10.93 3 122245 9921 42489166
Electroencephalogram abnormal 18.70 10.93 32 122216 2960 42496127
Sputum increased 18.69 10.93 33 122215 3130 42495957
Progressive multifocal leukoencephalopathy 18.64 10.93 5 122243 11531 42487556
International normalised ratio increased 18.61 10.93 73 122175 48095 42450992
Rash maculo-papular 18.52 10.93 51 122197 37452 42461635
Glycosylated haemoglobin increased 18.41 10.93 7 122241 12917 42486170
Plasma cell myeloma 18.32 10.93 213 122035 47365 42451722
Abdominal compartment syndrome 18.20 10.93 19 122229 1086 42498001
Erectile dysfunction 18.19 10.93 27 122221 24886 42474201
Intercepted product dispensing error 18.04 10.93 8 122240 104 42498983
Device failure 18.02 10.93 30 122218 2713 42496374
Cataract 17.97 10.93 38 122210 30566 42468521
Sweat gland disorder 17.97 10.93 8 122240 105 42498982
Squamous cell carcinoma of skin 17.95 10.93 7 122241 12719 42486368
Rhabdomyolysis 17.91 10.93 319 121929 77700 42421387
Neonatal respiratory depression 17.91 10.93 13 122235 453 42498634
Photosensitivity reaction 17.89 10.93 7 122241 12695 42486392
Product packaging issue 17.88 10.93 16 122232 755 42498332
Diabetes mellitus inadequate control 17.86 10.93 11 122237 15379 42483708
Weight decreased 17.82 10.93 457 121791 207491 42291596
Bladder dilatation 17.66 10.93 23 122225 1667 42497420
Spinal cord compression 17.56 10.93 38 122210 4186 42494901
Dyslipidaemia 17.42 10.93 3 122245 9415 42489672
Postoperative respiratory distress 17.40 10.93 5 122243 15 42499072
Eye pain 17.36 10.93 14 122234 17016 42482071
Infection 17.31 10.93 222 122026 111846 42387241
Systemic lupus erythematosus 17.18 10.93 3 122245 9321 42489766
Torsade de pointes 17.15 10.93 59 122189 8535 42490552
Cancer pain 17.07 10.93 34 122214 3533 42495554
Hypermagnesaemia 17.05 10.93 11 122237 315 42498772
Blood pressure systolic increased 17.04 10.93 34 122214 27934 42471153
Dyskinesia 17.03 10.93 128 122120 25262 42473825
Blindness 16.85 10.93 16 122232 17962 42481125
Cerebral ischaemia 16.81 10.93 51 122197 6908 42492179
Capillary nail refill test abnormal 16.79 10.93 6 122242 42 42499045
Oesophagitis ulcerative 16.78 10.93 17 122231 938 42498149
Blood test abnormal 16.77 10.93 8 122240 12898 42486189
Lymphadenopathy 16.76 10.93 45 122203 33320 42465767
Pathogen resistance 16.65 10.93 6 122242 11444 42487643
Hypercholesterolaemia 16.64 10.93 8 122240 12841 42486246
Loss of consciousness 16.62 10.93 364 121884 91990 42407097
Oxygen therapy 16.62 10.93 20 122228 1338 42497749
Postmortem blood drug level increased 16.62 10.93 13 122235 508 42498579
Asthenia 16.59 10.93 648 121600 280145 42218942
Tendonitis 16.54 10.93 4 122244 9890 42489197
Ear infection 16.54 10.93 8 122240 12796 42486291
Application site irritation 16.46 10.93 15 122233 725 42498362
Mechanical ventilation 16.45 10.93 26 122222 2251 42496836
Suspected counterfeit product 16.43 10.93 11 122237 336 42498751
Illness 16.34 10.93 29 122219 24901 42474186
Sedation 16.32 10.93 146 122102 30329 42468758
Product contamination 16.19 10.93 17 122231 978 42498109
Drug intolerance 16.15 10.93 150 122098 80274 42418813
Hyponatraemia 16.04 10.93 200 122048 101262 42397825
Product tampering 15.99 10.93 6 122242 49 42499038
Skin disorder 15.97 10.93 15 122233 16929 42482158
Respiratory symptom 15.84 10.93 6 122242 11100 42487987
Cardiac failure chronic 15.82 10.93 4 122244 9597 42489490
Oedema 15.82 10.93 86 122162 51915 42447172
No adverse event 15.81 10.93 58 122190 38963 42460124
Knee arthroplasty 15.81 10.93 3 122245 8778 42490309
Conversion disorder 15.79 10.93 13 122235 547 42498540
Yawning 15.75 10.93 15 122233 767 42498320
Hyperreflexia 15.63 10.93 33 122215 3574 42495513
Salivary hypersecretion 15.46 10.93 6 122242 10937 42488150
Electrocardiogram ST segment depression 15.46 10.93 28 122220 2709 42496378
Product administered at inappropriate site 15.39 10.93 30 122218 3068 42496019
Urinary bladder rupture 15.39 10.93 7 122241 97 42498990
Preternatural anus 15.32 10.93 7 122241 98 42498989
Impaired quality of life 15.29 10.93 11 122237 14166 42484921
Scoliosis 15.20 10.93 30 122218 3096 42495991
Large intestine anastomosis 15.11 10.93 6 122242 58 42499029
Ischaemic cerebral infarction 15.09 10.93 21 122227 1622 42497465
Lethargy 15.09 10.93 203 122045 46687 42452400
Sympathomimetic effect 15.06 10.93 4 122244 8 42499079
Laryngeal cancer metastatic 15.02 10.93 6 122242 59 42499028
Uveitis 14.99 10.93 4 122244 9254 42489833
Localised infection 14.95 10.93 22 122226 20351 42478736
Anaesthetic complication cardiac 14.93 10.93 5 122243 28 42499059
Neurological symptom 14.93 10.93 5 122243 9986 42489101
Therapeutic product effect prolonged 14.86 10.93 10 122238 308 42498779
Poor quality product administered 14.84 10.93 25 122223 2283 42496804
Blood catecholamines increased 14.78 10.93 5 122243 29 42499058
Orthostatic hypotension 14.78 10.93 42 122206 30528 42468559
Asphyxia 14.77 10.93 55 122193 8271 42490816
Haematuria 14.75 10.93 101 122147 57698 42441389
Urinary ascites 14.74 10.93 4 122244 9 42499078
Product dose omission in error 14.73 10.93 3 122245 8351 42490736
Injection site warmth 14.59 10.93 27 122221 2656 42496431
Hippocampal atrophy 14.57 10.93 3 122245 0 42499087
Craniectomy 14.57 10.93 3 122245 0 42499087
Prostate cancer metastatic 14.55 10.93 47 122201 6582 42492505
Air embolism 14.52 10.93 9 122239 240 42498847
Myelodysplastic syndrome 14.42 10.93 27 122221 22718 42476369
Hepatic cytolysis 14.41 10.93 35 122213 26809 42472278
Systemic infection 14.35 10.93 40 122208 5165 42493922
Epstein-Barr virus infection 14.28 10.93 5 122243 9713 42489374
Benign prostatic hyperplasia 14.24 10.93 24 122224 21028 42478059
Lymphopenia 14.21 10.93 25 122223 21538 42477549
Insomnia 14.20 10.93 246 122002 118007 42381080
Multiple sclerosis relapse 14.20 10.93 12 122236 14252 42484835
Hyponatraemic seizure 14.20 10.93 8 122240 178 42498909
Dehiscence 14.18 10.93 13 122235 633 42498454
Lung disorder 14.17 10.93 80 122168 47843 42451244
Haematuria traumatic 14.12 10.93 10 122238 335 42498752
Anal stenosis 14.12 10.93 10 122238 335 42498752
Cellulitis 14.09 10.93 111 122137 61474 42437613
Speech disorder 14.08 10.93 40 122208 29081 42470006
Respiratory tract infection bacterial 14.07 10.93 22 122226 1887 42497200
Joint stiffness 14.04 10.93 9 122239 12313 42486774
Hypophonesis 13.92 10.93 4 122244 12 42499075
Acute postoperative sialadenitis 13.92 10.93 4 122244 12 42499075
Diplopia 13.90 10.93 23 122225 20293 42478794
Spinal cord infarction 13.84 10.93 13 122235 653 42498434
Drug tolerance increased 13.82 10.93 11 122237 441 42498646
Aspergillus infection 13.81 10.93 15 122233 15822 42483265
Hypertensive crisis 13.81 10.93 62 122186 10144 42488943
Atelectasis 13.78 10.93 99 122149 19262 42479825
Oesophageal mucosa erythema 13.75 10.93 5 122243 37 42499050
Meningococcal bacteraemia 13.68 10.93 4 122244 13 42499074
Pemphigoid 13.58 10.93 8 122240 11459 42487628
Contusion 13.57 10.93 68 122180 41917 42457170
Skin haemorrhage 13.56 10.93 3 122245 7882 42491205
Quality of life decreased 13.55 10.93 40 122208 5336 42493751
Colorectal cancer recurrent 13.53 10.93 6 122242 78 42499009
Meningitis streptococcal 13.53 10.93 6 122242 78 42499009
Medical device site fistula 13.52 10.93 5 122243 39 42499048
Haematochezia 13.52 10.93 105 122143 58331 42440756
Product packaging quantity issue 13.50 10.93 18 122230 1335 42497752
Eosinophil count increased 13.49 10.93 7 122241 10756 42488331
Mucosal atrophy 13.46 10.93 6 122242 79 42499008
Anaesthetic complication pulmonary 13.33 10.93 6 122242 81 42499006
Pseudocholinesterase deficiency 13.33 10.93 6 122242 81 42499006
Tracheal pain 13.31 10.93 5 122243 41 42499046
Bronchopulmonary aspergillosis 13.28 10.93 22 122226 19407 42479680
Clinical trial participant 13.26 10.93 6 122242 82 42499005
PCO2 increased 13.21 10.93 13 122235 692 42498395
Swelling face 13.21 10.93 38 122210 27516 42471571
Immunosuppressant drug level increased 13.18 10.93 3 122245 7728 42491359
Nodule 13.16 10.93 10 122238 12524 42486563
Lymphoma 13.12 10.93 13 122235 14308 42484779
Parosmia 13.08 10.93 3 122245 7688 42491399
Acute kidney injury 13.02 10.93 893 121355 366444 42132643
Schizophrenia 13.02 10.93 7 122241 10543 42488544
Mania 13.01 10.93 7 122241 10540 42488547
Ventricular asystole 12.99 10.93 9 122239 291 42498796
Depressed mood 12.94 10.93 30 122218 23354 42475733
Pancreatitis acute 12.88 10.93 51 122197 33513 42465574
Toxicologic test abnormal 12.85 10.93 11 122237 489 42498598
Transplant rejection 12.84 10.93 12 122236 13576 42485511
Hepatic cirrhosis 12.84 10.93 23 122225 19679 42479408
Unwanted awareness during anaesthesia 12.81 10.93 5 122243 46 42499041
Injection site haemorrhage 12.79 10.93 9 122239 11727 42487360
Paralysis recurrent laryngeal nerve 12.76 10.93 6 122242 90 42498997
Diverticulum 12.70 10.93 3 122245 7538 42491549
Normochromic normocytic anaemia 12.68 10.93 5 122243 9026 42490061
Pseudopolyp 12.64 10.93 9 122239 304 42498783
Mean arterial pressure decreased 12.53 10.93 8 122240 225 42498862
Cerebral venous sinus thrombosis 12.52 10.93 13 122235 738 42498349
Diaphragmatic rupture 12.49 10.93 4 122244 19 42499068
Tumour pain 12.45 10.93 17 122231 1290 42497797
Urticaria 12.44 10.93 144 122104 73892 42425195
Rebound effect 12.31 10.93 3 122245 7376 42491711
Abdominal pain upper 12.26 10.93 165 122083 82444 42416643
Dependence 12.25 10.93 18 122230 1462 42497625
Restlessness 12.19 10.93 133 122115 29116 42469971
Multiple-drug resistance 12.17 10.93 3 122245 7319 42491768
Rash erythematous 12.16 10.93 49 122199 32042 42467045
BK virus infection 12.11 10.93 5 122243 8779 42490308
Trismus 12.05 10.93 26 122222 2858 42496229
Osteoporosis 12.05 10.93 15 122233 14891 42484196
Myopathy 12.04 10.93 13 122235 13748 42485339
Laryngomalacia 12.02 10.93 9 122239 329 42498758
Depression 12.02 10.93 236 122012 111127 42387960
Eye irritation 11.92 10.93 9 122239 11309 42487778
Renal cyst 11.90 10.93 7 122241 10032 42489055
Neuroendocrine tumour of the lung metastatic 11.88 10.93 7 122241 170 42498917
Dermatitis 11.81 10.93 10 122238 11865 42487222
Chest X-ray abnormal 11.80 10.93 34 122214 4474 42494613
Parkinsonism 11.77 10.93 8 122240 10615 42488472
Atrial septal defect 11.77 10.93 4 122244 7915 42491172
Iron deficiency anaemia 11.76 10.93 12 122236 13027 42486060
Application site erythema 11.73 10.93 24 122224 2542 42496545
Benzodiazepine drug level therapeutic 11.71 10.93 4 122244 24 42499063
Immune thrombocytopenia 11.71 10.93 9 122239 11207 42487880
Hepatic enzyme increased 11.68 10.93 80 122168 45704 42453383
Procedural nausea 11.64 10.93 6 122242 111 42498976
Non-small cell lung cancer 11.59 10.93 36 122212 4938 42494149
Arthrofibrosis 11.56 10.93 5 122243 61 42499026
Procedural hypertension 11.56 10.93 5 122243 61 42499026
Analgesic drug level increased 11.46 10.93 15 122233 1093 42497994
Complication of device removal 11.35 10.93 5 122243 64 42499023
Paralysis 11.33 10.93 45 122203 6975 42492112
Gingival erosion 11.31 10.93 4 122244 27 42499060
Pain in jaw 11.30 10.93 15 122233 14487 42484600
Pneumonia 11.29 10.93 1050 121198 421099 42077988
Mitochondrial encephalomyopathy 11.29 10.93 3 122245 6 42499081
Sympatholysis 11.29 10.93 3 122245 6 42499081
Dysgeusia 11.27 10.93 55 122193 34134 42464953
Discomfort 11.22 10.93 36 122212 25183 42473904
Apgar score abnormal 11.19 10.93 4 122244 28 42499059
Dyspepsia 11.18 10.93 71 122177 41281 42457806
Pathological fracture 11.14 10.93 37 122211 5256 42493831
Abdominal distension 11.11 10.93 142 122106 71593 42427494
Surgery 11.09 10.93 21 122227 17595 42481492
Facial wasting 11.09 10.93 6 122242 123 42498964
Tumour haemorrhage 11.08 10.93 29 122219 3609 42495478
Reversal of sedation 11.07 10.93 4 122244 29 42499058
Atonic urinary bladder 11.07 10.93 4 122244 29 42499058
Intentional dose omission 11.03 10.93 6 122242 8980 42490107
Pulmonary haemorrhage 11.03 10.93 63 122185 11334 42487753
Multiple organ dysfunction syndrome 10.99 10.93 360 121888 96675 42402412
Post procedural haematoma 10.98 10.93 18 122230 1607 42497480
Bile output abnormal 10.95 10.93 4 122244 30 42499057
Mobility decreased 10.95 10.93 58 122190 35248 42463839
Catecholamine crisis 10.95 10.93 5 122243 70 42499017

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug abuse 18680.19 10.37 8561 226834 168850 110185054
Toxicity to various agents 4698.94 10.37 5430 229965 475125 109878779
Respiratory arrest 2476.97 10.37 1544 233851 56755 110297149
Cardiac arrest 2245.30 10.37 2416 232979 194337 110159567
Cardio-respiratory arrest 1760.19 10.37 1662 233733 114174 110239730
Serotonin syndrome 1517.45 10.37 1148 234247 58005 110295899
Overdose 1304.11 10.37 2014 233381 231780 110122124
Respiratory depression 1294.54 10.37 822 234573 31179 110322725
Drug withdrawal syndrome 994.49 10.37 747 234648 37307 110316597
Prescription drug used without a prescription 993.12 10.37 391 235004 5105 110348799
Incorrect route of product administration 881.66 10.37 871 234524 63190 110290714
Death 821.56 10.37 3297 232098 695572 109658332
Unresponsive to stimuli 732.59 10.37 787 234608 63003 110290901
Anaphylactic reaction 666.52 10.37 1006 234389 113294 110240610
Drug interaction 615.95 10.37 2396 232999 497787 109856117
Hypotension 572.33 10.37 2418 232977 521431 109832473
Intentional product misuse 553.02 10.37 1005 234390 131899 110222005
Synovitis 517.89 10.37 14 235381 274078 110079826
Miosis 516.13 10.37 405 234990 21578 110332326
Depressed level of consciousness 500.43 10.37 875 234520 111403 110242501
Systemic lupus erythematosus 469.61 10.37 16 235379 254322 110099582
Drug dependence 463.31 10.37 552 234843 49468 110304436
Product adhesion issue 453.98 10.37 188 235207 2818 110351086
Hand deformity 442.53 10.37 4 235391 218502 110135402
Pemphigus 439.09 10.37 3 235392 214567 110139337
Inadequate analgesia 432.87 10.37 213 235182 4864 110349040
Apnoea 429.81 10.37 300 235095 13339 110340565
Glossodynia 416.92 10.37 12 235383 221992 110131912
Completed suicide 405.74 10.37 1286 234109 241095 110112809
Hyperaesthesia 402.33 10.37 297 235098 14430 110339474
Hyperthermia malignant 391.40 10.37 183 235212 3717 110350187
Joint swelling 389.27 10.37 230 235165 442615 109911289
Alopecia 377.35 10.37 152 235243 364601 109989303
Bradycardia 374.97 10.37 942 234453 154575 110199329
Pericarditis 371.60 10.37 24 235371 219090 110134814
Pulmonary oedema 363.86 10.37 717 234678 99942 110253962
Maternal exposure during delivery 363.10 10.37 169 235226 3396 110350508
Helicobacter infection 360.70 10.37 5 235390 181872 110172032
Delayed recovery from anaesthesia 359.96 10.37 146 235249 2069 110351835
Nasopharyngitis 344.88 10.37 206 235189 394155 109959749
Somnolence 343.76 10.37 1398 233997 296051 110057853
Duodenal ulcer perforation 343.61 10.37 7 235388 177693 110176211
Arthropathy 336.89 10.37 97 235298 287425 110066479
Drug use disorder 334.40 10.37 290 235105 17784 110336120
Folliculitis 322.60 10.37 7 235388 167646 110186258
Infusion related reaction 316.91 10.37 211 235184 380951 109972953
Arthralgia 314.02 10.37 752 234643 778880 109575024
Anaesthetic complication 306.58 10.37 151 235244 3455 110350449
Sinusitis 299.76 10.37 128 235267 296560 110057344
Myoclonus 292.22 10.37 356 235039 32642 110321262
Withdrawal syndrome 290.07 10.37 346 235049 31034 110322870
Muscle injury 283.09 10.37 3 235392 140804 110213100
Type 2 diabetes mellitus 281.97 10.37 26 235369 177206 110176698
Rash 277.28 10.37 863 234532 820101 109533803
Irritable bowel syndrome 275.44 10.37 19 235376 164196 110189708
Swelling 273.84 10.37 208 235187 350833 110003071
Abdominal discomfort 270.00 10.37 264 235131 393594 109960310
Accidental overdose 268.20 10.37 432 234963 51402 110302502
Lower respiratory tract infection 266.95 10.37 92 235303 243014 110110890
Agitation 266.40 10.37 679 234716 112372 110241532
Respiratory acidosis 262.19 10.37 225 235170 13601 110340303
Hypoxia 260.91 10.37 734 234661 128781 110225123
Hepatic enzyme increased 259.55 10.37 183 235212 320709 110033195
Weight increased 259.09 10.37 307 235088 419337 109934567
Rheumatoid arthritis 258.37 10.37 159 235236 299454 110054450
Brain oedema 253.73 10.37 322 235073 30776 110323128
Drug intolerance 250.31 10.37 298 235097 406214 109947690
Neuromuscular block prolonged 247.55 10.37 95 235300 1152 110352752
Peripheral swelling 244.73 10.37 300 235095 403734 109950170
Psoriatic arthropathy 242.50 10.37 60 235335 196701 110157203
Blood cholesterol increased 240.44 10.37 50 235345 184735 110169169
Fibromyalgia 240.17 10.37 38 235357 170871 110183033
Bradypnoea 233.05 10.37 173 235222 8476 110345428
Headache 232.77 10.37 1027 234368 881350 109472554
Asthma 231.28 10.37 122 235273 250169 110103735
Wound 229.13 10.37 106 235289 234331 110119573
Delirium 226.26 10.37 717 234678 134308 110219596
Contraindicated product administered 222.15 10.37 126 235269 248141 110105763
Pruritus 222.15 10.37 576 234819 580984 109772920
C-reactive protein abnormal 220.47 10.37 14 235381 129681 110224223
Amnestic disorder 219.19 10.37 76 235319 674 110353230
Accidental exposure to product by child 216.93 10.37 115 235280 3083 110350821
Off label use 215.70 10.37 2100 233295 1498085 108855819
Respiratory failure 213.84 10.37 967 234428 214365 110139539
Ill-defined disorder 211.31 10.37 39 235356 156814 110197090
Tachycardia 207.56 10.37 994 234401 225651 110128253
Treatment failure 206.44 10.37 172 235223 277062 110076842
Anaphylactic shock 196.98 10.37 376 235019 51170 110302734
Oxygen saturation decreased 196.59 10.37 757 234638 156225 110197679
Pulseless electrical activity 190.98 10.37 206 235189 16551 110337353
Joint range of motion decreased 190.79 10.37 19 235376 121813 110232091
Procedural hypotension 189.75 10.37 97 235298 2408 110351496
Lip dry 185.71 10.37 6 235389 100077 110253827
Fear 182.67 10.37 236 235159 22957 110330947
Product prescribing error 182.24 10.37 363 235032 50968 110302936
Wheezing 181.95 10.37 165 235230 255065 110098839
Bronchospasm 181.59 10.37 270 235125 29969 110323935
Fatigue 180.47 10.37 1688 233707 1214270 109139634
Stress cardiomyopathy 177.84 10.37 193 235202 15613 110338291
Coma 177.81 10.37 604 234791 117265 110236639
Cough 176.36 10.37 457 234938 461184 109892720
Blood pressure decreased 173.82 10.37 590 234805 114501 110239403
Mobility decreased 166.26 10.37 156 235239 237266 110116638
Respiratory rate decreased 163.76 10.37 123 235272 6135 110347769
Hypersensitivity 155.00 10.37 399 234996 403599 109950305
Hypoventilation 154.22 10.37 132 235263 7949 110345955
Stomatitis 153.90 10.37 210 235185 270032 110083872
Blister 152.73 10.37 155 235240 227221 110126683
Post procedural complication 151.51 10.37 232 235163 26426 110327478
Discomfort 150.42 10.37 141 235254 214566 110139338
Muscle rigidity 146.36 10.37 216 235179 23815 110330089
Musculoskeletal stiffness 145.15 10.37 232 235163 279590 110074314
Product dose omission issue 144.31 10.37 292 235103 321490 110032414
Malignant neoplasm progression 143.73 10.37 743 234652 173824 110180080
Bursitis 142.85 10.37 49 235346 129869 110224035
Opiates positive 142.72 10.37 59 235336 880 110353024
Substance use 141.98 10.37 80 235315 2426 110351478
Gastrointestinal disorder 141.86 10.37 184 235211 241768 110112136
Poisoning 138.99 10.37 234 235161 28871 110325033
Renal injury 138.98 10.37 185 235210 18528 110335376
Hypercholesterolaemia 137.55 10.37 16 235379 90821 110263083
Mental status changes 133.73 10.37 411 234984 75711 110278193
Urinary retention 133.55 10.37 388 235007 69295 110284609
Inflammation 131.75 10.37 130 235265 193108 110160796
Drug screen positive 131.17 10.37 109 235286 6301 110347603
Metabolic acidosis 130.62 10.37 488 234907 99256 110254648
Anhedonia 129.42 10.37 162 235233 15266 110338638
Haemodynamic instability 128.40 10.37 198 235197 22690 110331214
COVID-19 128.21 10.37 202 235193 244858 110109046
Injection site pain 128.00 10.37 114 235281 177808 110176096
Disorientation 127.35 10.37 385 235010 70286 110283618
Constipation 126.54 10.37 1240 234155 356546 109997358
Toxic leukoencephalopathy 126.51 10.37 64 235331 1553 110352351
Circulatory collapse 125.84 10.37 281 235114 42712 110311192
Deafness neurosensory 125.27 10.37 127 235268 9492 110344412
Liver injury 125.23 10.37 83 235312 150330 110203574
Grip strength decreased 124.24 10.37 13 235382 80161 110273743
Emotional distress 122.27 10.37 285 235110 44562 110309342
Impaired healing 121.18 10.37 144 235251 196573 110157331
Myoglobin urine present 120.48 10.37 52 235343 868 110353036
Brain injury 120.29 10.37 146 235249 13330 110340574
Procedural complication 118.75 10.37 116 235279 8289 110345615
Propofol infusion syndrome 118.56 10.37 72 235323 2517 110351387
Gastrooesophageal reflux disease 118.24 10.37 125 235270 179851 110174053
Drug diversion 117.95 10.37 58 235337 1322 110352582
Condition aggravated 116.59 10.37 1002 234393 733834 109620070
Obesity 115.85 10.37 48 235347 113303 110240601
Red blood cell sedimentation rate increased 115.60 10.37 15 235380 78287 110275617
Kounis syndrome 115.56 10.37 98 235297 5827 110348077
Presbyacusis 115.41 10.37 73 235322 2746 110351158
Peripheral venous disease 115.26 10.37 20 235375 84097 110269807
Cyanosis 114.92 10.37 218 235177 29523 110324381
Premature delivery 114.02 10.37 221 235174 30411 110323493
Pain in extremity 112.94 10.37 593 234802 486525 109867379
Hypercapnia 109.69 10.37 127 235268 11032 110342872
Laryngospasm 109.55 10.37 86 235309 4582 110349322
Loss of consciousness 109.16 10.37 754 234641 195552 110158352
Anterior spinal artery syndrome 107.60 10.37 33 235362 189 110353715
Ventricular tachycardia 107.17 10.37 290 235105 49719 110304185
Abdominal pain upper 106.53 10.37 383 235012 348728 110005176
Neoplasm progression 106.31 10.37 341 235054 64254 110289650
Diarrhoea 105.24 10.37 1750 233645 1137755 109216149
Knee arthroplasty 104.69 10.37 9 235386 64939 110288965
Product complaint 103.56 10.37 138 235257 13834 110340070
Clonus 100.82 10.37 108 235287 8608 110345296
Plasma cell myeloma 100.65 10.37 329 235066 62607 110291297
Tachypnoea 100.52 10.37 244 235151 39151 110314753
Autoimmune disorder 100.49 10.37 11 235384 65472 110288432
Faecaloma 98.08 10.37 139 235256 14769 110339135
Myelosuppression 97.95 10.37 39 235356 94301 110259603
Lung disorder 97.43 10.37 145 235250 179902 110174002
Counterfeit product administered 96.40 10.37 32 235363 245 110353659
Sleep disorder 96.25 10.37 172 235223 198472 110155432
Substance abuse 95.31 10.37 125 235270 12338 110341566
Product counterfeit 95.04 10.37 33 235362 294 110353610
Pleural fibrosis 93.91 10.37 76 235319 4232 110349672
Contusion 93.69 10.37 225 235170 233136 110120768
Lower limb fracture 92.76 10.37 23 235372 75325 110278579
Hypoxic-ischaemic encephalopathy 92.57 10.37 104 235291 8743 110345161
Infection 91.92 10.37 427 234968 361773 109992131
Pulmonary fibrosis 90.92 10.37 52 235343 101990 110251914
Dry mouth 90.83 10.37 180 235215 199768 110154136
Taste disorder 90.80 10.37 15 235380 65372 110288532
Sleep disorder due to a general medical condition 90.45 10.37 5 235390 52107 110301797
Night sweats 90.32 10.37 91 235304 133892 110220012
Dizziness 90.07 10.37 1001 234394 697192 109656712
Restlessness 88.98 10.37 293 235102 55966 110297938
Renal failure 88.90 10.37 803 234592 225771 110128133
Liver disorder 88.80 10.37 103 235292 142140 110211764
Urticaria 88.13 10.37 364 235031 318493 110035411
Hypoaesthesia 87.92 10.37 357 235038 313866 110040038
Encephalopathy 87.20 10.37 373 235022 80682 110273222
Psoriasis 86.71 10.37 102 235293 139891 110214013
Hip arthroplasty 86.60 10.37 9 235386 55804 110298100
Intensive care unit acquired weakness 86.50 10.37 57 235338 2302 110351602
Therapy naive 85.96 10.37 22 235373 55 110353849
Amphetamines positive 85.84 10.37 30 235365 273 110353631
Endotracheal intubation 85.32 10.37 84 235311 6060 110347844
Influenza 85.04 10.37 143 235252 168958 110184946
Arthritis 84.94 10.37 141 235254 167445 110186459
Narcotic bowel syndrome 84.36 10.37 29 235366 250 110353654
Product use issue 84.18 10.37 359 235036 311336 110042568
Osteoarthritis 84.17 10.37 163 235232 182460 110171444
Ear infection 83.61 10.37 16 235379 62716 110291188
Insomnia 83.50 10.37 439 234956 360151 109993753
Wrong technique in product usage process 81.25 10.37 385 235010 86963 110266941
Unevaluable event 81.08 10.37 294 235101 58933 110294971
Multiple organ dysfunction syndrome 80.97 10.37 577 234818 151133 110202771
Impaired driving ability 80.95 10.37 83 235312 6287 110347617
Drug abuser 80.85 10.37 77 235318 5332 110348572
Allodynia 80.46 10.37 52 235343 2031 110351873
Onychomadesis 80.45 10.37 4 235391 45659 110308245
Blood magnesium increased 80.29 10.37 66 235329 3757 110350147
Blood potassium increased 79.62 10.37 201 235194 33048 110320856
Wound infection 79.26 10.37 54 235341 96411 110257493
Brain death 78.78 10.37 83 235312 6490 110347414
Coeliac disease 78.68 10.37 3 235392 43184 110310720
Airway complication of anaesthesia 77.75 10.37 35 235360 649 110353255
Pneumonia aspiration 77.72 10.37 361 235034 80872 110273032
Gait inability 77.57 10.37 106 235289 136270 110217634
Blepharospasm 77.48 10.37 12 235383 54839 110299065
Labile blood pressure 77.03 10.37 54 235341 2417 110351487
Therapeutic product effect incomplete 76.87 10.37 233 235162 223572 110130332
Nail disorder 76.74 10.37 15 235380 57920 110295984
Pleural thickening 76.29 10.37 61 235334 3338 110350566
Product use in unapproved indication 75.38 10.37 600 234795 446777 109907127
Coma scale abnormal 75.08 10.37 98 235297 9628 110344276
Oedema 73.99 10.37 216 235179 209760 110144144
Acute respiratory distress syndrome 73.60 10.37 265 235130 52933 110300971
Endotracheal intubation complication 73.11 10.37 36 235359 823 110353081
Adverse event 72.09 10.37 75 235320 108734 110245170
Loss of personal independence in daily activities 71.68 10.37 131 235264 149889 110204015
Resuscitation 70.92 10.37 55 235340 2878 110351026
Intestinal pseudo-obstruction 70.62 10.37 58 235337 3298 110350606
Altered state of consciousness 70.54 10.37 276 235119 57350 110296554
Upper respiratory tract infection 69.85 10.37 107 235288 131221 110222683
Pulmonary congestion 69.81 10.37 183 235212 30783 110323121
Rhabdomyolysis 69.60 10.37 467 234928 119934 110233970
Recurrence of neuromuscular blockade 68.63 10.37 28 235367 403 110353501
Therapeutic product effect decreased 68.06 10.37 278 235117 244038 110109866
Sinus tachycardia 67.94 10.37 229 235166 44264 110309640
Inspiratory capacity decreased 67.89 10.37 51 235344 2544 110351360
Joint stiffness 67.86 10.37 29 235366 67214 110286690
Generalised tonic-clonic seizure 67.84 10.37 263 235132 54417 110299487
Negative pressure pulmonary oedema 67.68 10.37 32 235363 667 110353237
Hyperhidrosis 67.04 10.37 651 234744 186647 110167257
Malaise 66.75 10.37 1017 234378 670802 109683102
Hyperthermia 66.75 10.37 143 235252 21129 110332775
Neuromuscular blockade 65.78 10.37 32 235363 712 110353192
Anion gap 65.68 10.37 45 235350 1940 110351964
Pulse absent 65.19 10.37 99 235296 11193 110342711
Osteoporosis 64.90 10.37 54 235341 87098 110266806
Sedation 63.98 10.37 306 235089 69377 110284527
Airway peak pressure increased 63.90 10.37 30 235365 615 110353289
Leukoencephalopathy 63.87 10.37 88 235307 9107 110344797
Diabetes insipidus 63.28 10.37 74 235321 6496 110347408
Sciatica 63.14 10.37 62 235333 92337 110261567
Onychomycosis 63.04 10.37 5 235390 38526 110315378
Injection site reaction 62.93 10.37 58 235337 89012 110264892
Trigemino-cardiac reflex 62.92 10.37 27 235368 444 110353460
Pregnancy 62.06 10.37 16 235379 51051 110302853
Muscle spasms 61.96 10.37 343 235052 277814 110076090
Anaesthetic complication neurological 61.31 10.37 34 235361 999 110352905
Acute lung injury 61.21 10.37 52 235343 3099 110350805
Dyspnoea exertional 61.09 10.37 79 235316 103981 110249923
Systemic infection 60.86 10.37 89 235306 9730 110344174
Anterograde amnesia 60.42 10.37 32 235363 856 110353048
Metastases to bone 60.40 10.37 175 235220 31197 110322707
Local anaesthetic systemic toxicity 59.49 10.37 66 235329 5471 110348433
Femoral hernia incarcerated 59.10 10.37 38 235357 1471 110352433
Paraesthesia 58.89 10.37 346 235049 276175 110077729
C-reactive protein increased 58.81 10.37 251 235144 217668 110136236
Intercepted product dispensing error 58.78 10.37 21 235374 205 110353699
Spinal muscular atrophy 58.77 10.37 25 235370 402 110353502
Increased bronchial secretion 58.62 10.37 56 235339 3892 110350012
Prescribed underdose 58.36 10.37 33 235362 65141 110288763
Infusion site coldness 58.06 10.37 22 235373 257 110353647
Postmortem blood drug level abnormal 58.01 10.37 28 235367 612 110353292
Application site pruritus 58.00 10.37 57 235338 4103 110349801
Therapeutic product effect prolonged 57.88 10.37 29 235366 689 110353215
Dry skin 56.97 10.37 88 235307 107565 110246339
Lymphatic fistula 56.96 10.37 37 235358 1458 110352446
Acute respiratory failure 56.90 10.37 313 235082 74947 110278957
Therapeutic product effect increased 56.83 10.37 39 235356 1686 110352218
Nasal congestion 56.28 10.37 76 235319 98206 110255698
Myalgia 55.88 10.37 263 235132 222118 110131786
Chest discomfort 55.49 10.37 187 235208 173661 110180243
Drug-induced liver injury 55.46 10.37 107 235288 119960 110233944
Basal cell carcinoma 55.37 10.37 14 235381 45256 110308648
Transient ischaemic attack 55.03 10.37 34 235361 63948 110289956
Osteopenia 55.00 10.37 136 235259 22073 110331831
Bronchitis 54.98 10.37 162 235233 156870 110197034
Foot deformity 53.78 10.37 18 235377 48462 110305442
Cachexia 53.58 10.37 98 235297 12907 110340997
Device expulsion 53.50 10.37 3 235392 30888 110323016
Epigastric discomfort 53.41 10.37 80 235315 8935 110344969
Neurotoxicity 53.17 10.37 204 235191 42003 110311901
Tryptase increased 53.14 10.37 30 235365 913 110352991
Upper airway obstruction 52.98 10.37 38 235357 1764 110352140
Electrocardiogram ST segment elevation 52.44 10.37 80 235315 9080 110344824
Application site erythema 52.07 10.37 62 235333 5548 110348356
Palpitations 51.67 10.37 170 235225 159042 110194862
Herpes zoster 51.45 10.37 95 235300 108284 110245620
Wound infection pseudomonas 51.43 10.37 42 235353 2369 110351535
Dyspnoea 51.28 10.37 1884 233511 1104988 109248916
Myocardial ischaemia 50.56 10.37 148 235247 26536 110327368
Gamma-glutamyltransferase decreased 50.34 10.37 22 235373 379 110353525
Pancreatic steatosis 50.34 10.37 37 235358 1785 110352119
Hepatic cirrhosis 50.23 10.37 42 235353 67584 110286320
Renal impairment 49.91 10.37 617 234778 187828 110166076
Malignant catatonia 49.63 10.37 26 235369 680 110353224
Compartment syndrome 49.48 10.37 62 235333 5848 110348056
Coagulopathy 49.31 10.37 195 235200 40716 110313188
Hypermobility syndrome 49.25 10.37 24 235371 536 110353368
Accidental death 49.22 10.37 57 235338 4952 110348952
Spinal cord infarction 48.91 10.37 30 235365 1068 110352836
Application site rash 48.76 10.37 41 235354 2409 110351495
Paraplegia 48.68 10.37 63 235332 6137 110347767
Bradycardia foetal 48.49 10.37 16 235379 120 110353784
Laryngitis 48.36 10.37 15 235380 42396 110311508
Memory impairment 47.69 10.37 236 235159 196708 110157196
Injection site swelling 47.62 10.37 37 235358 61753 110292151
Ventricular fibrillation 47.46 10.37 194 235201 41119 110312785
Finger deformity 47.29 10.37 7 235388 33085 110320819
Product quality issue 47.20 10.37 304 235091 76995 110276909
Back injury 46.95 10.37 21 235374 47378 110306526
Toxic encephalopathy 46.28 10.37 101 235294 15113 110338791
Hyperreflexia 46.27 10.37 77 235318 9408 110344496
Tracheal deviation 46.23 10.37 19 235376 279 110353625
Visual impairment 46.11 10.37 140 235255 134288 110219616
Mydriasis 45.98 10.37 127 235268 22030 110331874
Prescribed overdose 45.95 10.37 72 235323 87509 110266395
Arteriospasm coronary 45.91 10.37 75 235320 9025 110344879
Dyskinesia 45.84 10.37 224 235171 51222 110302682
Supraventricular tachycardia 45.84 10.37 135 235260 24287 110329617
Paralysis 45.69 10.37 102 235293 15498 110338406
Epilepsy 45.67 10.37 90 235305 100119 110253785
Rash pruritic 45.63 10.37 87 235308 97982 110255922
Acidosis 45.63 10.37 128 235267 22403 110331501
Oropharyngeal pain 45.60 10.37 142 235253 135134 110218770
Respiratory distress 45.26 10.37 276 235119 68598 110285306
Phrenic nerve paralysis 45.24 10.37 23 235372 564 110353340
Skin exfoliation 45.10 10.37 73 235322 87578 110266326
Stridor 44.93 10.37 64 235331 6831 110347073
Postmortem blood drug level 44.92 10.37 19 235376 301 110353603
Migraine 44.91 10.37 200 235195 171452 110182452
Diabetes mellitus 44.66 10.37 90 235305 99291 110254613
Hallucination 44.19 10.37 368 235027 101064 110252840
Seroma 43.75 10.37 44 235351 3257 110350647
Apnoeic attack 43.52 10.37 25 235370 787 110353117
Carcinoid crisis 43.52 10.37 22 235373 533 110353371
Torsade de pointes 43.44 10.37 126 235269 22474 110331430
Injection site erythema 43.43 10.37 84 235311 94092 110259812
Lethargy 43.20 10.37 344 235051 93232 110260672
Abortion spontaneous 43.11 10.37 10 235385 34272 110319632
Acute postoperative sialadenitis 43.06 10.37 13 235382 70 110353834
Dermatitis atopic 42.68 10.37 3 235392 25538 110328366
Dehydration 42.08 10.37 832 234563 278679 110075225
Cardiac failure congestive 41.92 10.37 172 235223 150828 110203076
Accidental exposure to product 41.92 10.37 214 235181 49794 110304110
Rhythm idioventricular 41.62 10.37 24 235371 761 110353143
Methaemoglobinaemia 41.52 10.37 72 235323 9096 110344808
Breakthrough pain 41.29 10.37 31 235364 1545 110352359
Vasodilatation 40.87 10.37 45 235350 3699 110350205
Adverse drug reaction 40.61 10.37 104 235291 105455 110248449
Cytomegalovirus infection 40.21 10.37 34 235361 54410 110299494
Procedural hypertension 40.12 10.37 18 235377 331 110353573
Cancer pain 39.99 10.37 60 235335 6712 110347192
Exposure to toxic agent 39.84 10.37 86 235309 12772 110341132
Post procedural hypotension 39.81 10.37 13 235382 94 110353810
Fluid retention 39.38 10.37 89 235306 94218 110259686
Confusional state 39.37 10.37 1290 234105 467390 109886514
Piloerection 39.36 10.37 24 235371 845 110353059
Atrioventricular block second degree 39.36 10.37 66 235329 8115 110345789
Injection site pruritus 39.11 10.37 31 235364 51227 110302677
Radiculopathy 38.33 10.37 109 235286 19227 110334677
Hepatic ischaemia 38.21 10.37 27 235368 1224 110352680
Horner's syndrome 37.50 10.37 10 235385 31 110353873
Unwanted awareness during anaesthesia 37.39 10.37 18 235377 391 110353513
Osteosclerosis 37.22 10.37 47 235348 4468 110349436
Ear pain 37.20 10.37 35 235360 53191 110300713
Hepatic failure 36.98 10.37 262 235133 68477 110285427
Seizure like phenomena 36.96 10.37 35 235360 2406 110351498
Gait disturbance 36.91 10.37 396 234999 277812 110076092
Amylase increased 36.82 10.37 82 235313 12437 110341467
Arterial haemorrhage 36.76 10.37 43 235352 3776 110350128
Oedema peripheral 36.27 10.37 487 234908 328173 110025731
Conversion disorder 35.92 10.37 34 235361 2336 110351568
Eczema 35.54 10.37 62 235333 72231 110281673
Non-small cell lung cancer 35.52 10.37 62 235333 7873 110346031
Depression 35.47 10.37 469 234926 316866 110037038
Sneezing 35.26 10.37 12 235383 31972 110321932
Non-cardiogenic pulmonary oedema 35.02 10.37 31 235364 1953 110351951
Cataract 34.85 10.37 73 235322 79412 110274492
Delusion of parasitosis 34.67 10.37 15 235380 252 110353652
Accidental poisoning 34.53 10.37 34 235361 2453 110351451
Systolic anterior motion of mitral valve 34.49 10.37 11 235384 73 110353831
Productive cough 34.42 10.37 126 235269 114179 110239725
Dystonia 34.39 10.37 127 235268 25678 110328226
Product label confusion 34.31 10.37 4 235391 22673 110331231
Mean arterial pressure decreased 34.28 10.37 18 235377 473 110353431
Blood ethanol 34.16 10.37 12 235383 111 110353793
Ulcer haemorrhage 34.10 10.37 4 235391 22567 110331337
Hypothermia 33.85 10.37 128 235267 26174 110327730
Spinal cord compression 33.80 10.37 59 235336 7493 110346411
Bone cyst 33.74 10.37 40 235355 3563 110350341
Tachyarrhythmia 33.72 10.37 62 235333 8199 110345705
Spinal cord injury 33.42 10.37 28 235367 1637 110352267
Cerebrovascular accident 33.40 10.37 237 235158 181047 110172857
Anaesthetic complication pulmonary 33.34 10.37 13 235382 165 110353739
Sinus arrest 33.14 10.37 43 235352 4199 110349705
Female genital tract fistula 32.63 10.37 93 235302 16426 110337478
Left ventricle outflow tract obstruction 32.58 10.37 18 235377 525 110353379
Application site reaction 32.36 10.37 21 235374 826 110353078
Vasculitis 32.35 10.37 18 235377 35855 110318049
Therapy non-responder 32.33 10.37 199 235196 157108 110196796
Throat irritation 32.11 10.37 40 235355 53512 110300392
Therapeutic response decreased 32.03 10.37 102 235293 96397 110257507
Progressive multifocal leukoencephalopathy 31.94 10.37 7 235388 24949 110328955
Ventricular arrhythmia 31.87 10.37 68 235327 10019 110343885
Vasoplegia syndrome 31.84 10.37 48 235347 5391 110348513
Chest pain 31.67 10.37 587 234808 375788 109978116
Blood pressure diastolic abnormal 31.54 10.37 8 235387 25807 110328097
Full blood count abnormal 31.43 10.37 44 235351 56008 110297896
Drug ineffective 31.42 10.37 2799 232596 1517741 108836163
Disseminated intravascular coagulation 31.40 10.37 172 235223 41114 110312790
Diabetic ketoacidosis 31.39 10.37 26 235369 42032 110311872
Eye irritation 31.32 10.37 16 235379 33436 110320468
Cauda equina syndrome 31.32 10.37 30 235365 2092 110351812
Anticholinergic syndrome 31.30 10.37 42 235353 4238 110349666
Arachnoid web 31.24 10.37 7 235388 7 110353897
Stupor 31.21 10.37 60 235335 8205 110345699
Maternal exposure timing unspecified 31.07 10.37 4 235391 21009 110332895
Ventilation perfusion mismatch 31.04 10.37 20 235375 777 110353127
Autonomic nervous system imbalance 31.02 10.37 49 235346 5731 110348173
Stoma closure 31.01 10.37 16 235379 405 110353499
Hypogonadism 30.98 10.37 29 235366 1965 110351939
Nystagmus 30.93 10.37 73 235322 11504 110342400
Myotonia 30.89 10.37 14 235381 264 110353640
Postoperative delirium 30.89 10.37 21 235374 894 110353010
Illness 30.81 10.37 82 235313 82089 110271815
Oxygen saturation immeasurable 30.30 10.37 10 235385 75 110353829
Accident 30.28 10.37 70 235325 10882 110343022
Cardiac output decreased 30.06 10.37 29 235366 2040 110351864
Status epilepticus 29.97 10.37 140 235255 31431 110322473
Blood pressure systolic abnormal 29.79 10.37 8 235387 24842 110329062
Vomiting 29.71 10.37 2286 233109 908389 109445515
Swelling face 29.66 10.37 99 235296 92222 110261682
Non-consummation 29.57 10.37 9 235386 50 110353854
Anorectal ulcer 29.43 10.37 9 235386 51 110353853
Sinus congestion 29.38 10.37 14 235381 30445 110323459
Therapy interrupted 29.06 10.37 38 235357 49784 110304120
Asphyxia 29.02 10.37 81 235314 14134 110339770
Dyspepsia 29.02 10.37 263 235132 190702 110163202
Procedural pain 28.98 10.37 151 235244 35414 110318490
Drug resistance 28.95 10.37 47 235348 56327 110297577
Nephrolithiasis 28.87 10.37 61 235334 66151 110287753
Opisthotonus 28.84 10.37 19 235376 767 110353137
Haematemesis 28.77 10.37 220 235175 58888 110295016
Eye pruritus 28.77 10.37 17 235378 32758 110321146
Application site vesicles 28.74 10.37 25 235370 1539 110352365
Vaginal flatulence 28.64 10.37 73 235322 12071 110341833
Rhinorrhoea 28.46 10.37 117 235278 102549 110251355
Pneumococcal sepsis 28.43 10.37 29 235366 2183 110351721
Polyneuropathy in malignant disease 28.40 10.37 16 235379 485 110353419
Thermophobia 28.32 10.37 9 235386 59 110353845
Sepsis 28.24 10.37 904 234491 326442 110027462
Hepatic cytolysis 28.18 10.37 46 235349 55007 110298897
Wrong product administered 28.08 10.37 68 235327 10892 110343012
Injection site bruising 27.99 10.37 41 235354 51222 110302682
Mental status changes postoperative 27.98 10.37 12 235383 197 110353707
Therapeutic response shortened 27.92 10.37 14 235381 29569 110324335
Skin haemorrhage 27.92 10.37 9 235386 24818 110329086
Wound dehiscence 27.88 10.37 56 235339 7906 110345998
Areflexia 27.88 10.37 51 235344 6718 110347186
Anaesthetic complication cardiac 27.87 10.37 10 235385 99 110353805
Terminal insomnia 27.85 10.37 27 235368 1911 110351993
Intensive care unit delirium 27.81 10.37 9 235386 63 110353841
Motor neurone disease 27.78 10.37 18 235377 706 110353198
Postmortem blood drug level increased 27.65 10.37 22 235373 1195 110352709
Sopor 27.62 10.37 152 235243 36394 110317510
Drug tolerance decreased 27.59 10.37 12 235383 27528 110326376
Anaphylactoid reaction 27.57 10.37 51 235344 6775 110347129
Hypertension 27.55 10.37 851 234544 509233 109844671
Proctitis 27.52 10.37 89 235306 16838 110337066
Product dose omission in error 27.38 10.37 8 235387 23504 110330400
Infusion site induration 27.33 10.37 23 235372 1353 110352551
Postoperative ileus 27.29 10.37 22 235373 1218 110352686
Orthostatic hypotension 27.27 10.37 63 235332 66186 110287718
Poor quality product administered 27.23 10.37 41 235354 4600 110349304
Impaired quality of life 27.16 10.37 15 235380 30002 110323902
Pupil fixed 27.06 10.37 37 235358 3801 110350103
Pelvic pain 26.99 10.37 85 235310 15857 110338047
Antemortem blood drug level abnormal 26.99 10.37 9 235386 70 110353834
Yawning 26.97 10.37 24 235371 1523 110352381
Exposure via ingestion 26.94 10.37 42 235353 4858 110349046
Muscle relaxant therapy 26.80 10.37 11 235384 161 110353743
Porphyria acute 26.77 10.37 4 235391 18776 110335128
Sinus bradycardia 26.72 10.37 129 235266 29354 110324550
Spinal epidural haematoma 26.63 10.37 25 235370 1700 110352204
Postpartum haemorrhage 26.55 10.37 26 235369 1863 110352041
Product administration error 26.28 10.37 152 235243 37065 110316839
Toxicologic test abnormal 26.28 10.37 22 235373 1285 110352619
Application site dermatitis 26.25 10.37 11 235384 170 110353734
Atrioventricular dissociation 26.25 10.37 14 235381 380 110353524
Tumour pain 26.25 10.37 32 235363 2935 110350969
Ileus 26.10 10.37 132 235263 30597 110323307
Sedation complication 25.86 10.37 97 235298 19758 110334146
Procedural nausea 25.81 10.37 21 235374 1178 110352726
Locked-in syndrome 25.55 10.37 19 235376 933 110352971
Hypercapnic coma 25.34 10.37 15 235380 500 110353404
Prostate cancer metastatic 25.29 10.37 41 235354 4902 110349002
Vascular resistance systemic decreased 25.21 10.37 12 235383 254 110353650
Blood glucose increased 25.00 10.37 172 235223 132324 110221580
Quadriplegia 24.99 10.37 37 235358 4090 110349814
Polyarthritis 24.92 10.37 5 235390 18958 110334946
Hypotonia 24.89 10.37 82 235313 15663 110338241
Disease recurrence 24.86 10.37 58 235337 60726 110293178
Analgesic drug level increased 24.79 10.37 36 235359 3910 110349994
Air embolism 24.78 10.37 16 235379 624 110353280
Food allergy 24.72 10.37 6 235389 19942 110333962
Hepatorenal syndrome 24.71 10.37 39 235356 4558 110349346
Post procedural haemorrhage 24.71 10.37 81 235314 15431 110338473
Hypoperfusion 24.47 10.37 32 235363 3149 110350755
Neuropathy peripheral 24.25 10.37 254 235141 179023 110174881
Angina pectoris 24.25 10.37 61 235334 62234 110291670
Ventricular extrasystoles 24.20 10.37 104 235291 22537 110331367
Blood creatine phosphokinase increased 24.19 10.37 250 235145 72827 110281077
Application site irritation 24.18 10.37 25 235370 1912 110351992
Drug tolerance 24.13 10.37 84 235311 16501 110337403
Pseudomonal sepsis 24.12 10.37 57 235338 8989 110344915
Acute motor axonal neuropathy 24.08 10.37 10 235385 151 110353753
Cystitis 23.93 10.37 67 235328 65969 110287935
Atrioventricular block complete 23.62 10.37 95 235300 19987 110333917
Electrocardiogram ST segment depression 23.58 10.37 42 235353 5419 110348485
Drug detoxification 23.51 10.37 15 235380 573 110353331
Upper-airway cough syndrome 23.49 10.37 3 235392 15854 110338050
Walking aid user 23.47 10.37 12 235383 25063 110328841
Dependence 23.44 10.37 29 235366 2700 110351204
Potentiating drug interaction 23.43 10.37 66 235329 11577 110342327
Respiratory alkalosis 23.43 10.37 43 235352 5678 110348226
Oxygen therapy 23.39 10.37 36 235359 4117 110349787
Nodule 23.34 10.37 21 235374 32610 110321294
Mastocytosis 23.22 10.37 17 235378 815 110353089
Pathological fracture 23.05 10.37 67 235328 11965 110341939
Spinal anaesthesia 22.96 10.37 9 235386 116 110353788
Eye pain 22.82 10.37 45 235350 50054 110303850
Monoplegia 22.82 10.37 39 235356 4870 110349034
Blood pressure systolic increased 22.74 10.37 95 235300 82896 110271008
Intestinal ischaemia 22.72 10.37 81 235314 16098 110337806
Tuberculosis 22.72 10.37 5 235390 17769 110336135
Oculocardiac reflex 22.55 10.37 9 235386 122 110353782
Product contamination 22.46 10.37 24 235371 1907 110351997
Amnesia 22.36 10.37 132 235263 105276 110248628
Rhinitis 22.31 10.37 10 235385 22535 110331369
Tachyphylaxis 22.27 10.37 13 235382 422 110353482
Injection site rash 22.23 10.37 11 235384 23408 110330496
Tumour haemorrhage 22.21 10.37 40 235355 5205 110348699
Hypercreatininaemia 22.21 10.37 20 235375 1289 110352615
Atelectasis 22.18 10.37 144 235251 36568 110317336
Nausea 22.17 10.37 2977 232418 1232713 109121191
Laryngeal oedema 22.15 10.37 58 235337 9749 110344155
Multiple sclerosis relapse 22.14 10.37 46 235349 50194 110303710
Application site pain 22.10 10.37 41 235354 5458 110348446
End stage renal disease 22.08 10.37 9 235386 21464 110332440
Blood pressure increased 22.02 10.37 402 234993 257971 110095933
Respiratory tract congestion 21.90 10.37 20 235375 30837 110323067
Joint injury 21.83 10.37 32 235363 39962 110313942
Cyst 21.82 10.37 81 235314 16415 110337489
Neck pain 21.70 10.37 163 235232 122967 110230937
Muscular weakness 21.68 10.37 385 235010 248083 110105821
Pneumothorax 21.68 10.37 139 235256 35146 110318758
Eye swelling 21.64 10.37 23 235372 33025 110320879
Confusion postoperative 21.53 10.37 12 235383 356 110353548
Dyslipidaemia 21.43 10.37 4 235391 15961 110337943
Pneumonitis chemical 21.36 10.37 15 235380 673 110353231
Swollen tongue 21.32 10.37 62 235333 60300 110293604
Uterine hypertonus 21.30 10.37 11 235384 279 110353625
Type I hypersensitivity 21.25 10.37 44 235351 6349 110347555
Procedural haemorrhage 21.24 10.37 40 235355 5387 110348517
Transplant rejection 21.20 10.37 13 235382 24554 110329350
Nasal mucosal disorder 21.19 10.37 23 235372 1860 110352044
Bronchiectasis 21.11 10.37 28 235367 36465 110317439
Environmental exposure 21.06 10.37 12 235383 372 110353532
Medication error 20.98 10.37 328 235067 105038 110248866
Road traffic accident 20.97 10.37 138 235257 107260 110246644
Self-medication 20.84 10.37 43 235352 6189 110347715
Vision blurred 20.79 10.37 175 235220 128847 110225057
Skin sensitisation 20.79 10.37 18 235377 1101 110352803
Viral infection 20.71 10.37 52 235343 53087 110300817
Suicide attempt 20.62 10.37 132 235263 103262 110250642
Manufacturing production issue 20.62 10.37 4 235391 0 110353904
Coma blister 20.58 10.37 10 235385 222 110353682
Mechanical ventilation 20.53 10.37 30 235365 3277 110350627
Haemarthrosis 20.44 10.37 47 235348 7282 110346622
Metastases to spine 20.44 10.37 39 235356 5304 110348600
Hypermagnesaemia 20.36 10.37 21 235374 1602 110352302
Muscle spasticity 20.33 10.37 28 235367 35887 110318017
Product packaging quantity issue 20.29 10.37 22 235373 1777 110352127
Pseudocholinesterase deficiency 20.29 10.37 10 235385 229 110353675
Musculoskeletal pain 20.25 10.37 271 235124 182752 110171152
Hyperlipidaemia 20.24 10.37 28 235367 35820 110318084
Neuroleptic malignant syndrome 20.21 10.37 133 235262 33926 110319978
Agitation postoperative 20.20 10.37 7 235388 62 110353842
Ischaemic cerebral infarction 20.18 10.37 28 235367 2917 110350987
Asthenia 20.14 10.37 1231 234164 687768 109666136
Sinus disorder 20.09 10.37 24 235371 32704 110321200
Shock 20.02 10.37 188 235207 53400 110300504
Vaccination site reaction 19.98 10.37 10 235385 237 110353667
Blood ethanol increased 19.96 10.37 14 235381 627 110353277
Cardiac murmur 19.94 10.37 14 235381 24614 110329290
Blood pressure measurement 19.91 10.37 13 235382 517 110353387
Therapy partial responder 19.89 10.37 30 235365 37031 110316873
Nail bed inflammation 19.78 10.37 23 235372 2007 110351897
Spontaneous haemorrhage 19.60 10.37 18 235377 1190 110352714
Pseudopolyp 19.59 10.37 14 235381 646 110353258
Musculoskeletal disorder 19.55 10.37 12 235383 22652 110331252
Septic shock 19.53 10.37 456 234939 157072 110196832
Drug withdrawal syndrome neonatal 19.51 10.37 11 235384 334 110353570
Eosinophilia 19.39 10.37 61 235334 57875 110296029
Localised infection 19.32 10.37 39 235356 43009 110310895
Caesarean section 19.25 10.37 69 235326 13748 110340156
Blood uric acid increased 19.13 10.37 11 235384 21518 110332386
Post lumbar puncture syndrome 19.08 10.37 17 235378 1080 110352824
Uterine atony 19.07 10.37 10 235385 262 110353642
Drug eruption 19.03 10.37 55 235340 53604 110300300
Lung infiltration 18.99 10.37 103 235292 24525 110329379
Product administered at inappropriate site 18.97 10.37 38 235357 5355 110348549
Vasoconstriction 18.91 10.37 17 235378 1093 110352811
Deformity 18.91 10.37 56 235339 10104 110343800
Middle insomnia 18.91 10.37 10 235385 20492 110333412
Photosensitivity reaction 18.87 10.37 16 235379 25573 110328331
Troponin increased 18.75 10.37 118 235277 29648 110324256
Drug dose omission by device 18.72 10.37 4 235391 14512 110339392
Panniculitis 18.71 10.37 5 235390 15577 110338327
Haematuria traumatic 18.66 10.37 11 235384 364 110353540
Postoperative respiratory distress 18.63 10.37 5 235390 16 110353888
Exposure to extreme temperature 18.63 10.37 5 235390 16 110353888
Posturing 18.62 10.37 17 235378 1115 110352789
Documented hypersensitivity to administered product 18.60 10.37 17 235378 1117 110352787
Brain herniation 18.59 10.37 51 235344 8812 110345092
Listless 18.57 10.37 34 235361 4481 110349423
Drug tolerance increased 18.50 10.37 13 235382 584 110353320
Haematotoxicity 18.41 10.37 11 235384 21071 110332833
Subcutaneous emphysema 18.35 10.37 25 235370 2559 110351345
Forced expiratory volume decreased 18.34 10.37 3 235392 13173 110340731
Nervous system disorder 18.30 10.37 123 235272 31598 110322306
Exposure via skin contact 18.29 10.37 3 235392 13144 110340760
Heavy menstrual bleeding 18.28 10.37 6 235389 16359 110337545
Neurosis 18.25 10.37 13 235382 597 110353307
Cerebral ischaemia 18.21 10.37 62 235333 12042 110341862
Hydrocephalus 18.20 10.37 56 235339 10319 110343585
Cardiac massage 18.18 10.37 5 235390 18 110353886
Disturbance in attention 18.17 10.37 207 235188 61788 110292116
Streptococcal sepsis 18.15 10.37 36 235359 5036 110348868
Pulmonary alveolar haemorrhage 18.14 10.37 88 235307 20062 110333842
Chemical peritonitis 18.00 10.37 10 235385 295 110353609
Post procedural haematoma 17.94 10.37 25 235370 2614 110351290
Hepatitis 17.94 10.37 115 235280 89939 110263965
Blood pressure fluctuation 17.91 10.37 90 235305 74734 110279170
Phaeochromocytoma crisis 17.83 10.37 12 235383 502 110353402
Sensory disturbance 17.82 10.37 79 235316 17350 110336554
Impaired work ability 17.73 10.37 18 235377 26401 110327503
Prinzmetal angina 17.73 10.37 23 235372 2246 110351658
Device failure 17.71 10.37 44 235351 7163 110346741
Nightmare 17.62 10.37 35 235360 38828 110315076
Live birth 17.54 10.37 82 235313 69402 110284502
Acute chest syndrome 17.51 10.37 22 235373 2081 110351823
Granulocytopenia 17.47 10.37 3 235392 12712 110341192
Nerve block 17.37 10.37 14 235381 775 110353129
Pulmonary toxicity 17.36 10.37 8 235387 17738 110336166
Agranulocytosis 17.35 10.37 70 235325 61690 110292214
Preternatural anus 17.33 10.37 7 235388 98 110353806
Extradural haematoma 17.31 10.37 28 235367 3341 110350563
Bacterial infection 17.21 10.37 46 235349 45990 110307914
Perfume sensitivity 17.20 10.37 16 235379 1075 110352829
Bezold-Jarisch reflex 17.13 10.37 6 235389 55 110353849
Suspected counterfeit product 17.11 10.37 14 235381 792 110353112
Weight decreased 17.07 10.37 818 234577 467239 109886665
Long QT syndrome 17.01 10.37 43 235352 7075 110346829
Electrocardiogram QT prolonged 16.94 10.37 326 235069 108634 110245270
Aortic valve stenosis 16.92 10.37 40 235355 6310 110347594
Arthrofibrosis 16.84 10.37 7 235388 106 110353798
Cytomegalovirus infection reactivation 16.82 10.37 9 235386 18324 110335580
Hypogammaglobulinaemia 16.81 10.37 11 235384 20065 110333839
Oxidative stress 16.67 10.37 6 235389 60 110353844
Anion gap abnormal 16.66 10.37 14 235381 822 110353082
Acute pulmonary oedema 16.60 10.37 76 235319 16920 110336984
Foetal heart rate decreased 16.58 10.37 6 235389 61 110353843
Reversal of sedation 16.41 10.37 6 235389 63 110353841
Tongue disorder 16.41 10.37 5 235390 14293 110339611
Sphincter of Oddi dysfunction 16.38 10.37 12 235383 576 110353328
Decorticate posture 16.35 10.37 10 235385 354 110353550
Substance dependence 16.25 10.37 13 235382 712 110353192
Eosinophil cationic protein increased 16.24 10.37 6 235389 65 110353839
Gastrointestinal scarring 16.10 10.37 11 235384 472 110353432
Tendon rupture 16.01 10.37 5 235390 14073 110339831
Oesophageal intramural haematoma 16.01 10.37 8 235387 189 110353715
Lymphadenectomy 15.97 10.37 18 235377 1518 110352386
Vaginal discharge 15.97 10.37 78 235317 17830 110336074
Glycosylated haemoglobin increased 15.96 10.37 16 235379 23603 110330301
Myositis 15.92 10.37 26 235369 31090 110322814
Pain 15.87 10.37 1785 233610 953170 109400734
Psychomotor hyperactivity 15.77 10.37 85 235310 20192 110333712
Laboratory test abnormal 15.77 10.37 45 235350 44034 110309870
Dehiscence 15.74 10.37 13 235382 745 110353159
Breast cancer metastatic 15.72 10.37 56 235339 11125 110342779
Gout 15.68 10.37 34 235361 36532 110317372
Muscle tension dysphonia 15.68 10.37 9 235386 283 110353621
Weight bearing difficulty 15.66 10.37 28 235367 3623 110350281
Injection site haemorrhage 15.63 10.37 29 235366 32999 110320905
Temperature regulation disorder 15.62 10.37 4 235391 12822 110341082
Central nervous system stimulation 15.62 10.37 6 235389 73 110353831
Medical device site pain 15.60 10.37 10 235385 385 110353519
Cardiac failure chronic 15.54 10.37 5 235390 13806 110340098
Foreign body 15.54 10.37 25 235370 2970 110350934
Intentional dose omission 15.50 10.37 12 235383 20068 110333836
Uveitis 15.50 10.37 14 235381 21696 110332208
Drug effect faster than expected 15.46 10.37 3 235392 0 110353904
Cerebral artery perforation 15.46 10.37 3 235392 0 110353904
Peroneal nerve palsy postoperative 15.46 10.37 3 235392 0 110353904
Irregular breathing 15.46 10.37 12 235383 629 110353275
Euglycaemic diabetic ketoacidosis 15.41 10.37 3 235392 11620 110342284
Hospitalisation 15.39 10.37 212 235183 142281 110211623
Facial nerve disorder 15.39 10.37 13 235382 769 110353135
Exposure during pregnancy 15.38 10.37 466 234929 166958 110186946
Lower respiratory tract infection bacterial 15.38 10.37 15 235380 1070 110352834
Acne 15.36 10.37 30 235365 33490 110320414
Post-traumatic neck syndrome 15.33 10.37 23 235372 2572 110351332
Brachial plexopathy 15.29 10.37 9 235386 297 110353607
Manipulation 15.26 10.37 6 235389 78 110353826
Quadriparesis 15.18 10.37 32 235363 4675 110349229
Pleural neoplasm 15.17 10.37 10 235385 404 110353500
Sarcoidosis 15.17 10.37 4 235391 12575 110341329
Limb discomfort 15.14 10.37 41 235354 40813 110313091
Nerve stimulation test abnormal 15.10 10.37 4 235391 12 110353892
Pituitary apoplexy 15.04 10.37 9 235386 306 110353598
Enthesopathy 14.99 10.37 4 235391 12474 110341430
Breast cancer female 14.97 10.37 4 235391 12464 110341440
Medical device site fistula 14.87 10.37 5 235390 40 110353864
Aggression 14.87 10.37 192 235203 59018 110294886
Blood pressure diastolic increased 14.82 10.37 11 235384 18796 110335108
Arterial occlusive disease 14.82 10.37 7 235388 15301 110338603
Agonal respiration 14.81 10.37 9 235386 315 110353589
Colitis microscopic 14.81 10.37 5 235390 13389 110340515
Fear of death 14.78 10.37 18 235377 1649 110352255
Disturbance in social behaviour 14.73 10.37 33 235362 5025 110348879
Sweat gland disorder 14.71 10.37 8 235387 226 110353678
Malnutrition 14.68 10.37 104 235291 27175 110326729
Dilatation ventricular 14.68 10.37 29 235366 4046 110349858
Generalised onset non-motor seizure 14.67 10.37 6 235389 87 110353817
Cytopenia 14.64 10.37 26 235369 30090 110323814
Limb injury 14.53 10.37 37 235358 37599 110316305
Gastrointestinal motility disorder 14.40 10.37 41 235354 7235 110346669
Foot fracture 14.38 10.37 20 235375 25526 110328378
Appendicitis 14.37 10.37 24 235371 28440 110325464
Carcinoembryonic antigen 14.36 10.37 6 235389 92 110353812
Product storage error 14.36 10.37 15 235380 21713 110332191
Tubulointerstitial nephritis 14.34 10.37 63 235332 54221 110299683
Acute myeloid leukaemia 14.31 10.37 38 235357 38072 110315832
Head titubation 14.28 10.37 16 235379 1341 110352563
Pancreatic carcinoma metastatic 14.24 10.37 29 235366 4135 110349769
Abdominal compartment syndrome 14.23 10.37 19 235376 1908 110351996
Chronic obstructive pulmonary disease 14.21 10.37 156 235239 109002 110244902
Exposure via breast milk 14.17 10.37 14 235381 1014 110352890
Metastases to central nervous system 14.09 10.37 90 235305 22727 110331177
Euthyroid sick syndrome 14.08 10.37 6 235389 97 110353807
Carcinoid tumour 14.05 10.37 11 235384 584 110353320
Multiple lentigines syndrome 14.04 10.37 8 235387 248 110353656
Sputum increased 14.01 10.37 35 235360 5716 110348188
Drug screen negative 14.01 10.37 9 235386 348 110353556
End-tidal CO2 increased 13.98 10.37 5 235390 49 110353855
Euphoric mood 13.98 10.37 46 235349 8781 110345123
Carbohydrate antigen 15-3 13.91 10.37 6 235389 100 110353804
Large intestine anastomosis 13.91 10.37 6 235389 100 110353804
Capillary nail refill test abnormal 13.91 10.37 6 235389 100 110353804
Blood lactate dehydrogenase increased 13.89 10.37 150 235245 44184 110309720
Laryngeal cancer metastatic 13.89 10.37 5 235390 50 110353854
Slow response to stimuli 13.77 10.37 19 235376 1969 110351935
Product administered to patient of inappropriate age 13.75 10.37 43 235352 7993 110345911
Disease complication 13.71 10.37 35 235360 5792 110348112
Acute kidney injury 13.71 10.37 1549 233846 633881 109720023
Second primary malignancy 13.69 10.37 11 235384 18057 110335847
Respiratory tract infection bacterial 13.69 10.37 21 235374 2395 110351509
Hypophonesis 13.66 10.37 4 235391 19 110353885
Cutaneous vasculitis 13.65 10.37 5 235390 12724 110341180
Squamous cell carcinoma of skin 13.64 10.37 10 235385 17193 110336711
Incoherent 13.64 10.37 44 235351 8314 110345590
Immunodeficiency 13.63 10.37 40 235355 38798 110315106
Tracheal pain 13.63 10.37 5 235390 53 110353851
Gastroenteritis 13.59 10.37 40 235355 38760 110315144
Burkholderia test positive 13.58 10.37 11 235384 613 110353291
Neuroendocrine tumour of the lung metastatic 13.58 10.37 7 235388 177 110353727
Mucormycosis 13.56 10.37 3 235392 10625 110343279
Metabolic encephalopathy 13.55 10.37 53 235342 11007 110342897
Vitamin K deficiency 13.55 10.37 13 235382 908 110352996
Subdural effusion 13.54 10.37 6 235389 107 110353797
Mechanical ventilation complication 13.52 10.37 12 235383 759 110353145
Hypopnoea 13.52 10.37 54 235341 11326 110342578
Pneumocephalus 13.50 10.37 10 235385 488 110353416
Respiratory tract infection 13.49 10.37 93 235302 71524 110282380
Aspergillus infection 13.49 10.37 21 235374 25595 110328309
Rhinitis allergic 13.47 10.37 11 235384 17911 110335993
Leukopenia 13.47 10.37 229 235166 148562 110205342
Bradykinesia 13.47 10.37 52 235343 10736 110343168
Blood creatine phosphokinase MB increased 13.41 10.37 23 235372 2880 110351024
Moaning 13.37 10.37 16 235379 1439 110352465
Refusal of treatment by relative 13.37 10.37 12 235383 770 110353134
Diabetes mellitus inadequate control 13.34 10.37 27 235368 29748 110324156
Clinical trial participant 13.34 10.37 6 235389 111 110353793
Dermal absorption impaired 13.33 10.37 4 235391 21 110353883
Gaze palsy 13.19 10.37 25 235370 3382 110350522
Eye disorder 13.13 10.37 26 235369 28880 110325024
Skin disorder 13.12 10.37 47 235348 42866 110311038
Synovial cyst 13.11 10.37 4 235391 11426 110342478
Aortic arteriosclerosis 13.07 10.37 52 235343 10886 110343018
Depressed mood 12.98 10.37 76 235319 60733 110293171
Gastric cancer 12.89 10.37 52 235343 10956 110342948
Benzodiazepine drug level therapeutic 12.89 10.37 4 235391 24 110353880
Throat tightness 12.87 10.37 33 235362 33456 110320448
Bronchial disorder 12.83 10.37 22 235373 2754 110351150
Weight fluctuation 12.80 10.37 17 235378 22128 110331776
Plasmacytoma 12.79 10.37 32 235363 5230 110348674
Cardiogenic shock 12.78 10.37 182 235213 57156 110296748
Tracheostomy 12.75 10.37 16 235379 1511 110352393
Muscle atrophy 12.74 10.37 59 235336 13195 110340709
Hepatic cyst 12.72 10.37 41 235354 7742 110346162
Parotid gland enlargement 12.71 10.37 14 235381 1151 110352753
Pancreatic carcinoma 12.71 10.37 64 235331 14808 110339096
Hypernatraemia 12.70 10.37 73 235322 17760 110336144
BK virus infection 12.68 10.37 6 235389 13100 110340804
Diverticulum intestinal 12.65 10.37 54 235341 11665 110342239
Urine output decreased 12.65 10.37 79 235316 19797 110334107
Renal cyst 12.64 10.37 12 235383 18160 110335744
Seasonal allergy 12.61 10.37 14 235381 19708 110334196
Gastroenteritis viral 12.60 10.37 30 235365 31196 110322708
Performance status decreased 12.54 10.37 39 235356 7227 110346677
Ventricular asystole 12.51 10.37 9 235386 420 110353484
Abscess neck 12.50 10.37 15 235380 1353 110352551
Hypovolaemia 12.48 10.37 84 235311 21590 110332314
Metastases to lung 12.46 10.37 88 235307 22975 110330929
Paranoia 12.45 10.37 86 235309 22288 110331616
Incontinence 12.45 10.37 69 235326 16566 110337338
Procedural vomiting 12.44 10.37 13 235382 1007 110352897
Electroencephalogram abnormal 12.43 10.37 35 235360 6138 110347766
Skin maceration 12.43 10.37 7 235388 212 110353692
Carpal tunnel syndrome 12.43 10.37 18 235377 22592 110331312
General physical health deterioration 12.42 10.37 1059 234336 424236 109929668
Nephrotic syndrome 12.39 10.37 7 235388 13824 110340080
Creatinine renal clearance decreased 12.35 10.37 17 235378 21798 110332106
Thrombosis 12.34 10.37 160 235235 108502 110245402
Oculogyric crisis 12.30 10.37 26 235369 3806 110350098
Psychomotor skills impaired 12.29 10.37 38 235357 7020 110346884
Lymphopenia 12.28 10.37 44 235351 40126 110313778
Rash maculo-papular 12.26 10.37 100 235295 74122 110279782
Intervertebral disc compression 12.25 10.37 15 235380 1382 110352522
Neutropenia 12.25 10.37 662 234733 373958 109979946
Personality disorder 12.23 10.37 6 235389 12831 110341073
Groin pain 12.22 10.37 65 235330 15363 110338541
Fungal infection 12.22 10.37 61 235334 50745 110303159
Sympatholysis 12.18 10.37 3 235392 6 110353898
Hippocampal atrophy 12.18 10.37 3 235392 6 110353898
Lagophthalmos 12.09 10.37 10 235385 574 110353330
Vein disorder 12.09 10.37 35 235360 6235 110347669
Myocardial depression 12.06 10.37 11 235384 721 110353183
Hypertensive crisis 12.02 10.37 91 235304 24281 110329623
Seizure 12.02 10.37 581 234814 220604 110133300
Meningitis streptococcal 12.00 10.37 7 235388 227 110353677
Adjustment disorder 11.99 10.37 4 235391 10791 110343113
Hyperdynamic left ventricle 11.97 10.37 10 235385 582 110353322
Pain of skin 11.97 10.37 15 235380 20014 110333890
Pharyngitis 11.91 10.37 22 235373 25076 110328828
Acute graft versus host disease in skin 11.89 10.37 4 235391 10736 110343168
Bile output abnormal 11.79 10.37 4 235391 33 110353871
Alcohol interaction 11.78 10.37 25 235370 3669 110350235
Dysphonia 11.78 10.37 104 235291 75825 110278079
Decerebrate posture 11.75 10.37 7 235388 236 110353668
Dysgeusia 11.69 10.37 94 235301 69891 110284013
Insurance issue 11.66 10.37 4 235391 10608 110343296
Aplasia pure red cell 11.64 10.37 3 235392 9575 110344329
Spinal cord oedema 11.64 10.37 9 235386 469 110353435
Device dislocation 11.61 10.37 32 235363 31672 110322232
No adverse event 11.51 10.37 101 235294 73738 110280166
Normal newborn 11.51 10.37 83 235312 21813 110332091
Hypoalbuminaemia 11.50 10.37 103 235292 28871 110325033
Oxygen saturation abnormal 11.48 10.37 32 235363 5579 110348325
Pelvic fracture 11.46 10.37 60 235335 14094 110339810
Intentional self-injury 11.44 10.37 41 235354 37388 110316516
Hyperkalaemia 11.43 10.37 374 235021 135422 110218482
Gouty tophus 11.42 10.37 9 235386 482 110353422
Monoparesis 11.40 10.37 28 235367 4525 110349379
Paraparesis 11.35 10.37 28 235367 4538 110349366
Macular degeneration 11.33 10.37 82 235313 21577 110332327
Bone cement implantation syndrome 11.32 10.37 3 235392 9 110353895
Procedural headache 11.32 10.37 7 235388 253 110353651
Blood catecholamines increased 11.29 10.37 5 235390 89 110353815
Epstein-Barr virus infection 11.23 10.37 14 235381 18724 110335180
Endometriosis 11.22 10.37 27 235368 4307 110349597
Infusion site mass 11.20 10.37 16 235379 1712 110352192
Joint effusion 11.14 10.37 17 235378 20888 110333016
Meningococcal bacteraemia 11.11 10.37 4 235391 40 110353864
Adulterated product 11.11 10.37 13 235382 1142 110352762
Ileus paralytic 11.10 10.37 52 235343 11685 110342219
Pulmonary arterial hypertension 11.10 10.37 34 235361 32534 110321370
Lung consolidation 11.10 10.37 48 235347 10428 110343476
Bispectral index decreased 11.09 10.37 3 235392 10 110353894
Heart alternation 11.09 10.37 3 235392 10 110353894
Foetal heart rate deceleration abnormality 11.08 10.37 6 235389 168 110353736
Dermatitis 11.03 10.37 27 235368 27810 110326094
Abdominal distension 10.99 10.37 286 235109 174817 110179087
Anuria 10.97 10.37 89 235306 24252 110329652
Intracranial pressure increased 10.96 10.37 48 235347 10487 110343417
Catecholamine crisis 10.95 10.37 5 235390 96 110353808
Blood pH decreased 10.94 10.37 28 235367 4641 110349263
Optic neuritis 10.94 10.37 5 235390 11142 110342762
Cardiovascular symptom 10.90 10.37 5 235390 97 110353807
Pneumonia 10.88 10.37 1669 233726 875045 109478859
Sympathomimetic effect 10.86 10.37 6 235389 175 110353729
Aspiration 10.85 10.37 106 235289 30427 110323477
Blood albumin decreased 10.83 10.37 98 235297 27554 110326350
Premature separation of placenta 10.79 10.37 15 235380 1565 110352339
Transcranial electrical motor evoked potential monitoring abnormal 10.77 10.37 4 235391 44 110353860
Infantile apnoea 10.77 10.37 4 235391 44 110353860
Adverse reaction 10.74 10.37 30 235365 29564 110324340
Application site burn 10.72 10.37 12 235383 1005 110352899
Cardiovascular disorder 10.68 10.37 84 235311 22676 110331228
Sepsis syndrome 10.67 10.37 15 235380 1581 110352323
Left ventricular dysfunction 10.64 10.37 86 235309 23407 110330497
Priapism 10.62 10.37 32 235363 5829 110348075
Autoimmune pericarditis 10.58 10.37 5 235390 104 110353800
Interstitial lung disease 10.58 10.37 221 235174 139113 110214791
Impaired gastric emptying 10.56 10.37 56 235339 13219 110340685
Tremor 10.53 10.37 529 234866 201703 110152201
Influenza like illness 10.48 10.37 129 235266 88283 110265621
Skin burning sensation 10.47 10.37 19 235376 21806 110332098
Unintentional medical device removal 10.46 10.37 3 235392 8920 110344984
Chorea 10.44 10.37 22 235373 3213 110350691
Suicidal ideation 10.42 10.37 139 235256 93798 110260106
Intestinal infarction 10.41 10.37 14 235381 1416 110352488
Eosinophil count increased 10.40 10.37 18 235377 21040 110332864
Inappropriate antidiuretic hormone secretion 10.40 10.37 37 235358 33814 110320090
Pupillary reflex impaired 10.38 10.37 25 235370 3990 110349914

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
Muscle rigidity 53.79 27.04 12 351 4 113586
Intraventricular haemorrhage 29.09 27.04 12 351 117 113473

Pharmacologic Action:

SourceCodeDescription
ATC N01AH01 NERVOUS SYSTEM
ANESTHETICS
ANESTHETICS, GENERAL
Opioid anesthetics
ATC N01AH51 NERVOUS SYSTEM
ANESTHETICS
ANESTHETICS, GENERAL
Opioid anesthetics
ATC N02AB03 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Phenylpiperidine derivatives
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
MeSH PA D000759 Adjuvants, Anesthesia
MeSH PA D000777 Anesthetics
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009294 Narcotics
MeSH PA D018686 Anesthetics, Intravenous
MeSH PA D018689 Sensory System Agents
FDA MoA N0000175684 Full Opioid Agonists
FDA EPC N0000175690 Opioid Agonist
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35482 opioid analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:55322 ฮผ-opioid receptor agonist
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:73336 vulnerary
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:38867 anaesthetic
CHEBI has role CHEBI:38877 intravenous anaesthetic
CHEBI has role CHEBI:53784 antispasmodic drug
CHEBI has role CHEBI:60807 anaesthesia adjuvant
CHEBI has role CHEBI:60809 adjuvant
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:74518 anti-obesity agent

Related Drugs by ATC class:

N01AH Opioid anesthetics 5 drugs
alfentanilanileridinephenoperidineremifentanilsufentanil
N02AB Phenylpiperidine derivatives 2 drugs
ketobemidonepethidine

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

DiseaseRelationSNOMED_IDDOID
Pain indication 22253000
General anesthesia indication 50697003
Local anesthesia indication 386761002
Breakthrough cancer pain indication 879973007
Acute postoperative pain indication 107401000119105
Regional Anesthesia for Surgery indication
Chronic Pain with Opioid Tolerance indication
Regional Anesthesia for Postoperative Pain indication
Breakthrough Pain in Opioid Tolerant Patients indication
Anesthesia for cesarean section off-label use 4847005
Severe pain off-label use 76948002
Conscious sedation off-label use 314271007
Regional Anesthesia for Labor Pain off-label use
Sedation in Intubated Patients off-label use
Alcoholism contraindication 7200002
Cardiomegaly contraindication 8186001
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Chronic disease of respiratory system contraindication 17097001
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Complete atrioventricular block contraindication 27885002
Shock contraindication 27942005
Hypovolemia contraindication 28560003
Orthostatic hypotension contraindication 28651003
Torsades de pointes contraindication 31722008
Dehydration contraindication 34095006
Depressive disorder contraindication 35489007
Migraine contraindication 37796009 DOID:6364
Hypertensive disorder contraindication 38341003 DOID:10763
Hypokalemia contraindication 43339004
Decreased cardiac function contraindication 43650005
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Paralytic ileus contraindication 55525008 DOID:8442
Hepatic failure contraindication 59927004
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Extrapyramidal disease contraindication 76349003
Urethral stricture contraindication 76618002
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Cor pulmonale contraindication 83291003 DOID:8515
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Disorder of biliary tract contraindication 105997008 DOID:9741
Prolonged QT interval contraindication 111975006
Procedure on urinary system contraindication 118677009
Hypomagnesemia contraindication 190855004
Asthma contraindication 195967001 DOID:2841
Acute pancreatitis contraindication 197456007 DOID:2913
Headache disorder contraindication 230461009
Disease of liver contraindication 235856003 DOID:409
Sepsis syndrome contraindication 238150007
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Lesion of brain contraindication 301766008
Pheochromocytoma contraindication 302835009
Deficiency of cholinesterase contraindication 360607009
Central nervous system depression contraindication 418072004
Congenital long QT syndrome contraindication 442917000
Acute exacerbation of asthma contraindication 708038006
Headache Pain especially in Patients who are not Opiate Tolerant contraindication
Pain in Opioid Naive Patients contraindication
Refractory Extrinsic Asthma contraindication




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Dogs Postoperative pain associated with surgical procedures Indication
Dogs Analgesia and tranquilizers Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Innovar-Vet Injection Intervet Inc. 2

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.62 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 DISCN SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 DISCN SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 DISCN SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 DISCN SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 DISCN SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 DISCN SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
EQ 0.2MG BASE ONSOLIS ADALVO N022266 July 16, 2009 DISCN FILM BUCCAL 9597288 July 23, 2027 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE ONSOLIS ADALVO N022266 July 16, 2009 DISCN FILM BUCCAL 9597288 July 23, 2027 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.6MG BASE ONSOLIS ADALVO N022266 July 16, 2009 DISCN FILM BUCCAL 9597288 July 23, 2027 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.8MG BASE ONSOLIS ADALVO N022266 July 16, 2009 DISCN FILM BUCCAL 9597288 July 23, 2027 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 1.2MG BASE ONSOLIS ADALVO N022266 July 16, 2009 DISCN FILM BUCCAL 9597288 July 23, 2027 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 DISCN SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 DISCN SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
EQ 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 DISCN SYSTEM IONTOPHORESIS, TRANSDERMAL 9364656 Sept. 30, 2031 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
EQ 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 DISCN SYSTEM IONTOPHORESIS, TRANSDERMAL 8781571 March 31, 2032 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
EQ 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 DISCN SYSTEM IONTOPHORESIS, TRANSDERMAL 8428708 May 21, 2032 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
EQ 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 DISCN SYSTEM IONTOPHORESIS, TRANSDERMAL 8428709 June 11, 2032 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Mu-type opioid receptor GPCR AGONIST EC50 9.00 WOMBAT-PK CHEMBL
D(2) dopamine receptor GPCR Ki 4.68 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor IC50 6.45 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.74 CHEMBL
Alpha-1A adrenergic receptor GPCR Ki 5.85 CHEMBL
D(3) dopamine receptor GPCR Ki 4.58 CHEMBL
D(4) dopamine receptor GPCR Ki 6.26 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 5.96 CHEMBL
Kappa-type opioid receptor GPCR Ki 6.71 CHEMBL
Delta-type opioid receptor GPCR Ki 6.17 CHEMBL
Solute carrier family 22 member 1 Transporter IC50 4.34 CHEMBL
Monoamine oxidase Enzyme Ki 5.26 CHEMBL
Mu-type opioid receptor GPCR Ki 8.82 CHEMBL
Mu-type opioid receptor GPCR Ki 8.23 CHEMBL
Mu-type opioid receptor GPCR Ki 8.07 CHEMBL
Delta-type opioid receptor GPCR IC50 8.03 CHEMBL
Delta-type opioid receptor GPCR Ki 6.40 CHEMBL
Kappa-type opioid receptor GPCR Ki 6.71 CHEMBL
Histamine H1 receptor GPCR IC50 4.70 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane other IC50 5.30 CHEMBL
Opioid receptor GPCR Ki 8.67 CHEMBL

External reference:

IDSource
4018745 VUID
N0000147049 NUI
D00320 KEGG_DRUG
990-73-8 SECONDARY_CAS_RN
4018744 VANDF
4018745 VANDF
C0015846 UMLSCUI
CHEBI:119915 CHEBI
CHEMBL596 ChEMBL_ID
CHEMBL688 ChEMBL_ID
DB00813 DRUGBANK_ID
CHEMBL1201159 ChEMBL_ID
D005283 MESH_DESCRIPTOR_UI
3345 PUBCHEM_CID
1626 IUPHAR_LIGAND_ID
1608 INN_ID
1443-54-5 SECONDARY_CAS_RN
UF599785JZ UNII
142436 RXNORM
29441 MMSL
4632 MMSL
4721 MMSL
4722 MMSL
64408 MMSL
d00233 MMSL
001568 NDDF
003571 NDDF
011514 NDDF
29190006 SNOMEDCT_US
373492002 SNOMEDCT_US
40648001 SNOMEDCT_US
7V7 PDB_CHEM_ID
UF599785JZ INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7865 LOZENGE 200 ug ORAL NDA authorized generic 33 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7866 LOZENGE 400 ug ORAL NDA authorized generic 33 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7867 LOZENGE 600 ug ORAL NDA authorized generic 33 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7868 LOZENGE 800 ug ORAL NDA authorized generic 33 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7869 LOZENGE 1200 ug ORAL NDA authorized generic 33 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7870 LOZENGE 1600 ug ORAL NDA authorized generic 33 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9119 PATCH 12 ug TRANSDERMAL ANDA 35 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9119 PATCH 12 ug TRANSDERMAL ANDA 35 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9121 PATCH 25 ug TRANSDERMAL ANDA 35 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9121 PATCH 25 ug TRANSDERMAL ANDA 35 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9122 PATCH 50 ug TRANSDERMAL ANDA 35 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9122 PATCH 50 ug TRANSDERMAL ANDA 35 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9123 PATCH 75 ug TRANSDERMAL ANDA 35 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9123 PATCH 75 ug TRANSDERMAL ANDA 35 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9124 PATCH 100 ug TRANSDERMAL ANDA 35 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9124 PATCH 100 ug TRANSDERMAL ANDA 35 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9125 PATCH 37.50 ug TRANSDERMAL ANDA 35 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9125 PATCH 37.50 ug TRANSDERMAL ANDA 35 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9126 PATCH 62.50 ug TRANSDERMAL ANDA 35 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9126 PATCH 62.50 ug TRANSDERMAL ANDA 35 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9127 PATCH 87.50 ug TRANSDERMAL ANDA 35 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9127 PATCH 87.50 ug TRANSDERMAL ANDA 35 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9037 PATCH, EXTENDED RELEASE 37.50 ug TRANSDERMAL ANDA 38 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9062 PATCH, EXTENDED RELEASE 62.50 ug TRANSDERMAL ANDA 38 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9100 PATCH, EXTENDED RELEASE 100 ug TRANSDERMAL ANDA 38 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9112 PATCH, EXTENDED RELEASE 12.50 ug TRANSDERMAL ANDA 38 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9125 PATCH, EXTENDED RELEASE 25 ug TRANSDERMAL ANDA 38 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9150 PATCH, EXTENDED RELEASE 50 ug TRANSDERMAL ANDA 38 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9175 PATCH, EXTENDED RELEASE 75 ug TRANSDERMAL ANDA 38 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0409-9093 INJECTION, SOLUTION 50 ug INTRAMUSCULAR NDA 34 sections