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

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 3845.32 10.22 2255 140609 70263 63275895
Toxicity to various agents 1270.23 10.22 2112 140752 245138 63101020
Respiratory arrest 764.18 10.22 614 142250 32031 63314127
Product adhesion issue 760.39 10.22 314 142550 4405 63341753
Cardiac arrest 711.19 10.22 956 141908 91589 63254569
Death 647.80 10.22 2080 140784 372301 62973857
Cardio-respiratory arrest 601.77 10.22 708 142156 59251 63286907
Serotonin syndrome 599.14 10.22 505 142359 28177 63317981
Respiratory depression 553.16 10.22 359 142505 13356 63332802
Drug withdrawal syndrome 444.89 10.22 417 142447 26777 63319381
Inadequate analgesia 437.77 10.22 185 142679 2758 63343400
Overdose 432.47 10.22 860 142004 114218 63231940
Systemic lupus erythematosus 387.68 10.22 20 142844 208898 63137260
Product quality issue 382.31 10.22 437 142427 35428 63310730
Alopecia 370.79 10.22 148 142716 337388 63008770
Incorrect route of product administration 336.64 10.22 360 142504 27092 63319066
Glossodynia 335.43 10.22 16 142848 178860 63167298
Synovitis 334.25 10.22 22 142842 186896 63159262
Hand deformity 332.89 10.22 5 142859 159452 63186706
Drug interaction 323.34 10.22 1191 141673 227940 63118218
Anaphylactic reaction 322.49 10.22 553 142311 65547 63280611
Accidental overdose 313.22 10.22 321 142543 22988 63323170
Maternal exposure during delivery 304.82 10.22 118 142746 1382 63344776
Product prescribing error 301.83 10.22 333 142531 25956 63320202
Arthropathy 292.41 10.22 83 142781 234709 63111449
Hypotension 277.99 10.22 1282 141582 271322 63074836
Intentional product misuse 262.82 10.22 483 142381 60434 63285724
Joint swelling 255.85 10.22 217 142647 327449 63018709
Infusion related reaction 249.90 10.22 120 142744 245401 63100757
Apnoea 238.39 10.22 174 142690 7848 63338310
Pericarditis 236.62 10.22 15 142849 131564 63214594
Product complaint 232.02 10.22 208 142656 12601 63333557
Abdominal discomfort 229.78 10.22 230 142634 320655 63025503
Bradycardia 229.14 10.22 508 142356 72719 63273439
Unresponsive to stimuli 229.01 10.22 329 142535 33487 63312671
Drug dependence 225.62 10.22 277 142587 24206 63321952
Wrong technique in product usage process 224.56 10.22 458 142406 61882 63284276
Wound 222.05 10.22 48 142816 163215 63182943
Somnolence 213.74 10.22 882 141982 177803 63168355
Rash 202.84 10.22 620 142244 560251 62785907
Withdrawal syndrome 201.89 10.22 237 142627 19760 63326398
Sinusitis 198.75 10.22 133 142731 226520 63119638
Swelling 198.68 10.22 196 142668 275182 63070976
Contraindicated product administered 197.28 10.22 123 142741 217525 63128633
Arthralgia 193.28 10.22 648 142216 569062 62777096
Anaesthetic complication 191.92 10.22 92 142772 1868 63344290
Nasopharyngitis 190.38 10.22 175 142689 254082 63092076
Helicobacter infection 189.11 10.22 4 142860 92781 63253377
Drug intolerance 186.74 10.22 253 142611 308408 63037750
Prescription drug used without a prescription 177.63 10.22 93 142771 2293 63343865
Hepatic enzyme increased 177.01 10.22 119 142745 202209 63143949
Delayed recovery from anaesthesia 175.90 10.22 66 142798 705 63345453
Miosis 171.31 10.22 138 142726 7215 63338943
Accidental exposure to product by child 167.52 10.22 72 142792 1121 63345037
Treatment failure 163.73 10.22 125 142739 198918 63147240
Depressed level of consciousness 159.69 10.22 399 142465 61679 63284479
Completed suicide 159.37 10.22 700 142164 144973 63201185
Fatigue 154.04 10.22 1271 141593 886757 62459401
Delirium 154.00 10.22 347 142517 50194 63295964
Procedural hypotension 145.00 10.22 65 142799 1125 63345033
Myoclonus 143.73 10.22 178 142686 15690 63330468
Lower respiratory tract infection 140.21 10.22 61 142803 132246 63213912
Folliculitis 136.04 10.22 5 142859 70312 63275846
Malignant neoplasm progression 135.55 10.22 450 142414 81671 63264487
Myoglobin urine present 129.90 10.22 53 142811 719 63345439
Headache 129.78 10.22 864 142000 632377 62713781
Muscle injury 128.69 10.22 4 142860 65341 63280817
Hypersensitivity 127.95 10.22 294 142570 292391 63053767
Peripheral swelling 125.46 10.22 256 142608 265686 63080472
Application site rash 124.96 10.22 75 142789 2423 63343735
Hyperaesthesia 124.11 10.22 128 142736 9230 63336928
Irritable bowel syndrome 123.25 10.22 19 142845 82393 63263765
Neuromuscular block prolonged 122.21 10.22 46 142818 496 63345662
Respiratory rate decreased 121.97 10.22 84 142780 3451 63342707
Bradypnoea 121.65 10.22 84 142780 3466 63342692
Pleural fibrosis 120.97 10.22 83 142781 3389 63342769
Discomfort 119.61 10.22 120 142744 167254 63178904
Presbyacusis 117.97 10.22 76 142788 2789 63343369
Blood potassium increased 117.93 10.22 174 142690 18135 63328023
Cough 114.75 10.22 311 142553 292432 63053726
Respiratory acidosis 113.69 10.22 105 142759 6610 63339548
White blood cell count abnormal 112.32 10.22 101 142763 6141 63340017
Product use issue 112.08 10.22 203 142661 220317 63125841
Coma 110.06 10.22 357 142507 64007 63282151
Agitation 109.08 10.22 339 142525 59418 63286740
Injection site pain 108.64 10.22 80 142784 129720 63216438
Pulmonary oedema 108.34 10.22 320 142544 54553 63291605
Rheumatoid arthritis 106.09 10.22 261 142603 253558 63092600
Weight increased 105.26 10.22 273 142591 260519 63085639
Deafness neurosensory 104.46 10.22 87 142777 4768 63341390
Stress cardiomyopathy 103.80 10.22 117 142747 9333 63336825
Kounis syndrome 99.89 10.22 57 142807 1673 63344485
Psoriatic arthropathy 97.26 10.22 42 142822 91478 63254680
Bronchospasm 94.15 10.22 152 142712 17128 63329030
Hyperthermia malignant 93.55 10.22 43 142821 791 63345367
Respiratory failure 93.35 10.22 465 142399 101393 63244765
Hypoxia 92.79 10.22 321 142543 59471 63286687
Blood magnesium increased 92.77 10.22 67 142797 2971 63343187
Condition aggravated 91.41 10.22 531 142333 401686 62944472
Pleural thickening 91.29 10.22 65 142799 2818 63343340
Application site erythema 90.51 10.22 80 142784 4755 63341403
Oxygen saturation decreased 90.29 10.22 417 142447 88168 63257990
Constipation 87.52 10.22 831 142033 224112 63122046
C-reactive protein abnormal 86.74 10.22 4 142860 46092 63300066
Circulatory collapse 85.95 10.22 167 142697 21771 63324387
Labile blood pressure 85.08 10.22 52 142812 1737 63344421
Type 2 diabetes mellitus 84.33 10.22 20 142844 63848 63282310
Hip arthroplasty 83.95 10.22 6 142858 47640 63298518
Tachycardia 82.49 10.22 501 142363 117655 63228503
Knee arthroplasty 82.19 10.22 12 142852 54194 63291964
Anaphylactic shock 81.96 10.22 171 142693 23462 63322696
Pruritus 80.60 10.22 480 142384 360973 62985185
Urinary retention 80.26 10.22 197 142667 30104 63316054
Ill-defined disorder 80.00 10.22 42 142822 81713 63264445
Blood cholesterol increased 79.91 10.22 57 142807 93975 63252183
Encephalopathy 79.86 10.22 229 142635 38391 63307767
Pulseless electrical activity 79.02 10.22 91 142773 7430 63338728
Hypoventilation 77.90 10.22 73 142791 4681 63341477
Application site vesicles 76.79 10.22 45 142819 1390 63344768
Application site pruritus 76.74 10.22 67 142797 3917 63342241
Toxic encephalopathy 74.91 10.22 83 142781 6496 63339662
Brain oedema 74.81 10.22 123 142741 14072 63332086
Medication error 74.53 10.22 273 142591 52011 63294147
Premature delivery 74.06 10.22 191 142673 30090 63316068
Poisoning 73.94 10.22 120 142744 13580 63332578
Blister 73.82 10.22 111 142753 129703 63216455
Plasma cell myeloma 72.40 10.22 211 142653 35694 63310464
Blood pressure decreased 70.67 10.22 312 142552 64710 63281448
Faecaloma 70.18 10.22 88 142776 7853 63338305
Injection site erythema 69.92 10.22 51 142813 83123 63263035
Amylase increased 68.74 10.22 78 142786 6267 63339891
Neoplasm progression 68.65 10.22 209 142655 36219 63309939
Stomatitis 68.40 10.22 130 142734 138595 63207563
Therapeutic product effect incomplete 68.18 10.22 110 142754 124946 63221212
Drug diversion 67.87 10.22 36 142828 912 63345246
Troponin increased 67.81 10.22 98 142766 10023 63336135
Injection site reaction 66.87 10.22 24 142840 58500 63287658
Application site reaction 66.81 10.22 33 142831 717 63345441
Hypermobility syndrome 66.80 10.22 34 142830 789 63345369
Opiates positive 66.66 10.22 27 142837 359 63345799
Application site irritation 66.14 10.22 44 142820 1706 63344452
Device expulsion 65.81 10.22 3 142861 34919 63311239
Anterior spinal artery syndrome 65.57 10.22 20 142844 105 63346053
Fear 64.19 10.22 122 142742 15644 63330514
Drug abuser 64.18 10.22 53 142811 2870 63343288
Drug use disorder 63.98 10.22 67 142797 4917 63341241
Intercepted product dispensing error 63.38 10.22 19 142845 93 63346065
Epigastric discomfort 62.92 10.22 77 142787 6703 63339455
Infusion site coldness 62.36 10.22 22 142842 194 63345964
Drug ineffective 62.23 10.22 1835 141029 1042930 62303228
Restlessness 62.21 10.22 176 142688 29277 63316881
Multiple organ dysfunction syndrome 62.19 10.22 273 142591 56479 63289679
Off label use 61.35 10.22 1109 141755 673353 62672805
Breakthrough pain 61.27 10.22 37 142827 1209 63344949
Muscle rigidity 61.08 10.22 100 142764 11400 63334758
Ventricular tachycardia 60.64 10.22 137 142727 19842 63326316
Fibromyalgia 60.52 10.22 55 142809 80365 63265793
Mental status changes 60.05 10.22 211 142653 39388 63306770
Abortion spontaneous 59.94 10.22 16 142848 47179 63298979
Sedation 59.89 10.22 208 142656 38601 63307557
Hallucination 58.03 10.22 261 142603 54556 63291602
Toxic leukoencephalopathy 57.99 10.22 30 142834 721 63345437
Osteopenia 57.10 10.22 133 142731 19652 63326506
COVID-19 56.62 10.22 105 142759 112998 63233160
Liver injury 56.44 10.22 33 142831 60487 63285671
Haemodynamic instability 55.84 10.22 85 142779 9105 63337053
Asthma 55.76 10.22 128 142736 127433 63218725
Loss of consciousness 55.51 10.22 455 142409 117666 63228492
Pain in extremity 55.46 10.22 478 142386 331008 63015150
Post procedural complication 55.11 10.22 120 142744 16954 63329204
Therapeutic product effect increased 54.44 10.22 34 142830 1181 63344977
Generalised tonic-clonic seizure 54.23 10.22 166 142698 28850 63317308
Gamma-glutamyltransferase decreased 53.95 10.22 22 142842 298 63345860
Vaginal flatulence 52.88 10.22 50 142814 3243 63342915
Drug screen positive 52.44 10.22 52 142812 3577 63342581
Therapy naive 52.40 10.22 13 142851 25 63346133
Renal failure 52.00 10.22 447 142417 117205 63228953
Female genital tract fistula 51.82 10.22 74 142790 7485 63338673
Influenza 51.75 10.22 104 142760 108618 63237540
Application site pain 51.52 10.22 55 142809 4127 63342031
Renal impairment 50.87 10.22 357 142507 87998 63258160
Procedural complication 50.84 10.22 62 142802 5377 63340781
Dependence 50.56 10.22 40 142824 2037 63344121
Application site dermatitis 50.12 10.22 18 142846 168 63345990
Vomiting 49.86 10.22 1628 141236 557989 62788169
Emotional distress 49.84 10.22 174 142690 32375 63313783
Bone cyst 49.76 10.22 41 142823 2213 63343945
Hyperhidrosis 49.39 10.22 413 142451 107423 63238735
Radiculopathy 48.63 10.22 77 142787 8534 63337624
Therapeutic product effect prolonged 48.23 10.22 21 142843 338 63345820
Normal newborn 47.68 10.22 75 142789 8266 63337892
Vasodilatation 47.59 10.22 41 142823 2354 63343804
Allodynia 47.33 10.22 27 142837 792 63345366
Red blood cell sedimentation rate increased 47.01 10.22 20 142844 43962 63302196
Hepatic ischaemia 46.93 10.22 25 142839 639 63345519
Metastases to bone 46.75 10.22 128 142736 20891 63325267
Disorientation 46.47 10.22 194 142670 39258 63306900
Confusional state 45.84 10.22 767 142097 235613 63110545
Neuromuscular blockade 45.21 10.22 19 142845 279 63345879
Proctitis 44.47 10.22 58 142806 5383 63340775
Bradycardia foetal 44.32 10.22 21 142843 415 63345743
Carcinoid crisis 43.87 10.22 18 142846 248 63345910
Ventilation perfusion mismatch 43.80 10.22 22 142842 496 63345662
Dehydration 43.11 10.22 587 142277 172767 63173391
Gastrointestinal disorder 43.10 10.22 151 142713 131088 63215070
Abdominal pain upper 42.91 10.22 280 142584 206164 63139994
Osteosclerosis 42.46 10.22 48 142816 3840 63342318
Renal injury 42.14 10.22 76 142788 9363 63336795
Mobility decreased 42.12 10.22 136 142728 121023 63225135
Inflammation 41.51 10.22 76 142788 82197 63263961
Product dose omission issue 41.36 10.22 333 142531 233980 63112178
Laryngospasm 41.21 10.22 42 142822 2986 63343172
Rhythm idioventricular 40.49 10.22 17 142847 249 63345909
Altered state of consciousness 40.48 10.22 137 142727 25093 63321065
Unwanted awareness during anaesthesia 39.72 10.22 18 142846 320 63345838
Bronchitis 39.53 10.22 146 142718 124789 63221369
Nasal congestion 39.43 10.22 54 142810 65606 63280552
Wheezing 39.33 10.22 99 142765 95496 63250662
Product administration error 38.96 10.22 125 142739 22272 63323886
Spontaneous haemorrhage 38.02 10.22 21 142843 578 63345580
Myalgia 37.89 10.22 185 142679 146344 63199814
Endotracheal intubation complication 37.84 10.22 19 142845 428 63345730
Product counterfeit 37.78 10.22 14 142850 144 63346014
Therapeutic product effect decreased 37.67 10.22 267 142597 192920 63153238
Infection 37.61 10.22 332 142532 228841 63117317
Cancer pain 37.47 10.22 41 142823 3164 63342994
Pulse absent 37.42 10.22 53 142811 5321 63340837
Clonus 37.24 10.22 49 142815 4587 63341571
Systemic infection 37.04 10.22 49 142815 4611 63341547
General physical health deterioration 37.03 10.22 648 142216 200754 63145404
Amnestic disorder 37.02 10.22 17 142847 312 63345846
Ear infection 36.83 10.22 20 142844 38193 63307965
Cyanosis 36.55 10.22 102 142762 16833 63329325
Diarrhoea 36.50 10.22 1281 141583 714085 62632073
Injection site swelling 36.43 10.22 32 142832 47540 63298618
Anhedonia 36.42 10.22 78 142786 10896 63335262
Femoral hernia incarcerated 36.34 10.22 23 142841 818 63345340
Dystonia 35.70 10.22 89 142775 13730 63332428
Myocardial ischaemia 35.54 10.22 85 142779 12774 63333384
Wound infection pseudomonas 35.42 10.22 27 142837 1301 63344857
Horner's syndrome 35.41 10.22 9 142855 20 63346138
Neurotoxicity 35.36 10.22 101 142763 16889 63329269
Lymphatic fistula 35.23 10.22 22 142842 764 63345394
Spinal cord injury 35.08 10.22 23 142841 870 63345288
Mental status changes postoperative 34.58 10.22 14 142850 186 63345972
Contusion 34.57 10.22 197 142667 149847 63196311
Exposure during pregnancy 34.39 10.22 516 142348 155031 63191127
Hepatic failure 34.22 10.22 165 142699 35491 63310667
Anaesthetic complication neurological 34.03 10.22 15 142849 249 63345909
Intentional self-injury 33.99 10.22 8 142856 25679 63320479
Injection site pruritus 33.76 10.22 31 142833 45085 63301073
Airway complication of anaesthesia 33.53 10.22 14 142850 202 63345956
Gastrooesophageal reflux disease 33.48 10.22 107 142757 95532 63250626
Metabolic acidosis 33.28 10.22 194 142670 44875 63301283
Product packaging issue 33.23 10.22 25 142839 1181 63344977
Haematemesis 33.09 10.22 146 142718 30266 63315892
Pregnancy 33.07 10.22 21 142843 36815 63309343
Product administered at inappropriate site 32.91 10.22 38 142826 3111 63343047
Local anaesthetic systemic toxicity 32.53 10.22 22 142842 877 63345281
Airway peak pressure increased 32.43 10.22 15 142849 280 63345878
Monoplegia 32.40 10.22 38 142826 3163 63342995
Pancreatic steatosis 32.39 10.22 23 142841 993 63345165
Palpitations 32.36 10.22 137 142727 112633 63233525
Hepatorenal syndrome 32.30 10.22 30 142834 1902 63344256
Upper respiratory tract infection 32.20 10.22 87 142777 81960 63264198
Wrong product administered 32.07 10.22 53 142811 6088 63340070
Recurrence of neuromuscular blockade 31.67 10.22 12 142852 132 63346026
Seroma 31.66 10.22 31 142833 2100 63344058
Sepsis 31.57 10.22 502 142362 152621 63193537
Psoriasis 31.35 10.22 96 142768 86861 63259297
Arthritis 31.34 10.22 144 142720 115777 63230381
Arterial haemorrhage 31.32 10.22 28 142836 1689 63344469
Basal cell carcinoma 31.10 10.22 12 142852 27979 63318179
Procedural hypertension 31.09 10.22 15 142849 309 63345849
Nausea 31.07 10.22 2276 140588 852195 62493963
Arachnoid web 30.86 10.22 7 142857 7 63346151
Hypercreatininaemia 30.80 10.22 18 142846 553 63345605
Infusion site induration 30.75 10.22 24 142840 1198 63344960
Breast cancer metastatic 30.62 10.22 77 142787 11941 63334217
Cauda equina syndrome 30.37 10.22 22 142842 980 63345178
Paralysis 30.17 10.22 68 142796 9832 63336326
Oropharyngeal pain 30.16 10.22 110 142754 94377 63251781
Intestinal pseudo-obstruction 29.89 10.22 21 142843 891 63345267
Herpes zoster 29.75 10.22 91 142773 82371 63263787
Hypoxic-ischaemic encephalopathy 29.44 10.22 42 142822 4245 63341913
Ocular hyperaemia 29.26 10.22 10 142854 25134 63321024
Application site burn 29.20 10.22 20 142844 814 63345344
Muscle relaxant therapy 29.13 10.22 12 142852 167 63345991
Anorectal ulcer 29.08 10.22 9 142855 50 63346108
Chest discomfort 28.91 10.22 138 142726 109831 63236327
Joint stiffness 28.77 10.22 31 142833 41838 63304320
Non-consummation 28.64 10.22 9 142855 53 63346105
Cyst 28.56 10.22 83 142781 14016 63332142
Impaired healing 28.55 10.22 126 142738 102416 63243742
Postoperative delirium 28.47 10.22 10 142854 87 63346071
Ventricular fibrillation 28.14 10.22 74 142790 11793 63334365
Accidental death 27.97 10.22 28 142836 1948 63344210
Amphetamines positive 27.74 10.22 12 142852 190 63345968
Blood lactate dehydrogenase increased 27.48 10.22 114 142750 23002 63323156
Dizziness 27.44 10.22 747 142117 429178 62916980
Tracheal deviation 26.84 10.22 11 142853 151 63346007
Loss of personal independence in daily activities 26.81 10.22 120 142744 97170 63248988
Cardiogenic shock 26.71 10.22 95 142769 17837 63328321
Type I hypersensitivity 26.63 10.22 33 142831 2909 63343249
Myelosuppression 26.60 10.22 10 142854 23693 63322465
Spinal anaesthesia 26.55 10.22 8 142856 40 63346118
Product packaging quantity issue 26.47 10.22 23 142841 1336 63344822
Cardiac output decreased 26.45 10.22 20 142844 952 63345206
Pupil fixed 26.28 10.22 26 142838 1783 63344375
Coma scale abnormal 26.28 10.22 44 142820 5109 63341049
Substance abuse 25.80 10.22 42 142822 4765 63341393
Grip strength decreased 25.70 10.22 9 142855 22278 63323880
Acute postoperative sialadenitis 25.56 10.22 7 142857 23 63346135
Interstitial lung disease 25.55 10.22 64 142800 61844 63284314
Confusion postoperative 25.47 10.22 12 142852 234 63345924
Tooth loss 25.41 10.22 51 142813 6805 63339353
Multiple sclerosis relapse 25.15 10.22 44 142820 48434 63297724
Coagulopathy 24.96 10.22 102 142762 20442 63325716
Drug tolerance 24.93 10.22 51 142813 6898 63339260
Lethargy 24.83 10.22 213 142651 55794 63290364
Phrenic nerve paralysis 24.82 10.22 11 142853 185 63345973
C-reactive protein increased 24.80 10.22 119 142745 94588 63251570
Poor quality product administered 24.80 10.22 33 142831 3123 63343035
Osteoporosis 24.67 10.22 58 142806 57280 63288878
Pulmonary fibrosis 24.65 10.22 32 142832 39777 63306381
Musculoskeletal stiffness 24.63 10.22 281 142583 184337 63161821
Post procedural haemorrhage 24.60 10.22 55 142809 7909 63338249
Anaesthetic complication pulmonary 24.53 10.22 8 142856 54 63346104
Non-small cell lung cancer 24.36 10.22 35 142829 3560 63342598
Therapeutic response decreased 24.32 10.22 65 142799 61460 63284698
Cataract 24.31 10.22 58 142806 56995 63289163
Supraventricular tachycardia 24.24 10.22 79 142785 14192 63331966
Cachexia 24.17 10.22 45 142819 5681 63340477
Liver disorder 24.16 10.22 53 142811 53634 63292524
Tachyarrhythmia 24.04 10.22 39 142825 4411 63341747
Head titubation 23.93 10.22 18 142846 850 63345308
Drug specific antibody 23.91 10.22 28 142836 2327 63343831
Exposure via ingestion 23.76 10.22 31 142833 2878 63343280
Pseudopolyp 23.67 10.22 12 142852 276 63345882
Anticholinergic syndrome 23.65 10.22 28 142836 2354 63343804
Skin sensitisation 23.55 10.22 18 142846 871 63345287
Stridor 23.53 10.22 34 142830 3476 63342682
Vaginal discharge 23.51 10.22 59 142805 9139 63337019
Atrioventricular block second degree 23.50 10.22 36 142828 3878 63342280
Adverse drug reaction 23.39 10.22 96 142768 79618 63266540
Left ventricle outflow tract obstruction 23.36 10.22 12 142852 284 63345874
Apnoeic attack 23.32 10.22 12 142852 285 63345873
Myotonia 23.31 10.22 10 142854 155 63346003
Uterine hypertonus 23.21 10.22 12 142852 288 63345870
Mydriasis 22.90 10.22 69 142795 11887 63334271
Musculoskeletal disorder 22.69 10.22 9 142855 20635 63325523
Upper airway obstruction 22.61 10.22 16 142848 687 63345471
Blood pressure diastolic abnormal 22.56 10.22 3 142861 14539 63331619
Sphincter of Oddi dysfunction 22.55 10.22 13 142851 389 63345769
Dyskinesia 22.50 10.22 136 142728 31866 63314292
Product tampering 22.08 10.22 13 142851 405 63345753
Acute respiratory failure 22.03 10.22 143 142721 34342 63311816
Anaphylactoid reaction 22.01 10.22 34 142830 3689 63342469
Adverse event 21.99 10.22 78 142786 67481 63278677
Pituitary apoplexy 21.93 10.22 9 142855 124 63346034
Eye irritation 21.91 10.22 11 142853 21960 63324198
Application site perspiration 21.84 10.22 6 142858 20 63346138
Respiratory distress 21.82 10.22 141 142723 33810 63312348
Hypovolaemia 21.78 10.22 63 142801 10610 63335548
Haemarthrosis 21.75 10.22 31 142833 3130 63343028
Arteriospasm coronary 21.74 10.22 35 142829 3933 63342225
Transient ischaemic attack 21.72 10.22 32 142832 37721 63308437
Disturbance in social behaviour 21.58 10.22 35 142829 3958 63342200
Accidental exposure to product 21.57 10.22 120 142744 27285 63318873
Opisthotonus 21.28 10.22 12 142852 344 63345814
Retinopathy of prematurity 21.19 10.22 12 142852 347 63345811
Listless 21.10 10.22 29 142835 2831 63343327
Tenosynovitis 21.03 10.22 3 142861 13792 63332366
Eczema 21.00 10.22 25 142839 32266 63313892
Quadriplegia 21.00 10.22 23 142841 1777 63344381
Abscess neck 20.91 10.22 15 142849 658 63345500
Pneumothorax 20.77 10.22 82 142782 16179 63329979
Narcotic bowel syndrome 20.72 10.22 9 142855 144 63346014
Vascular resistance systemic decreased 20.64 10.22 8 142856 94 63346064
Potentiating drug interaction 20.64 10.22 36 142828 4320 63341838
Diabetes mellitus 20.55 10.22 61 142803 55749 63290409
Drug screen negative 20.51 10.22 11 142853 285 63345873
Rhinorrhoea 20.50 10.22 77 142787 65500 63280658
Pain 20.41 10.22 1414 141450 739214 62606944
Exposure to extreme temperature 20.40 10.22 4 142860 0 63346158
Dyspnoea 20.18 10.22 1251 141613 660062 62686096
Vasoconstriction 20.18 10.22 14 142850 582 63345576
Peripheral venous disease 20.13 10.22 5 142859 15472 63330686
Dyspnoea exertional 20.04 10.22 69 142795 60233 63285925
Post-traumatic neck syndrome 19.97 10.22 24 142840 2050 63344108
Brain injury 19.95 10.22 47 142817 6996 63339162
Mean arterial pressure decreased 19.91 10.22 9 142855 159 63345999
Spinal epidural haematoma 19.81 10.22 18 142846 1109 63345049
Cerebrovascular accident 19.74 10.22 152 142712 107872 63238286
Product monitoring error 19.70 10.22 36 142828 4480 63341678
Hypercapnia 19.65 10.22 40 142824 5391 63340767
Gouty tophus 19.53 10.22 10 142854 235 63345923
Hypercholesterolaemia 19.37 10.22 12 142852 21322 63324836
Visual impairment 19.37 10.22 111 142753 84335 63261823
Progressive multifocal leukoencephalopathy 19.37 10.22 3 142861 12968 63333190
Retinal detachment 19.32 10.22 42 142822 5927 63340231
Postpartum haemorrhage 19.20 10.22 23 142841 1958 63344200
Injection site bruising 19.16 10.22 41 142823 41869 63304289
Mean arterial pressure increased 19.12 10.22 5 142859 13 63346145
Endometriosis 19.04 10.22 39 142825 5281 63340877
Vaccination site reaction 18.82 10.22 8 142856 121 63346037
Hypopnoea 18.75 10.22 32 142832 3774 63342384
Methaemoglobinaemia 18.69 10.22 25 142839 2378 63343780
Gastrointestinal scarring 18.68 10.22 11 142853 343 63345815
Anaemia 18.67 10.22 823 142041 292607 63053551
Application site erosion 18.63 10.22 9 142855 186 63345972
Dental caries 18.60 10.22 60 142804 10719 63335439
Generalised onset non-motor seizure 18.60 10.22 5 142859 15 63346143
Brain death 18.58 10.22 30 142834 3380 63342778
Acute respiratory distress syndrome 18.49 10.22 103 142761 23431 63322727
Facial nerve disorder 18.41 10.22 13 142851 556 63345602
Drug hypersensitivity 18.38 10.22 865 141999 309822 63036336
Hyperreflexia 18.35 10.22 41 142823 5893 63340265
Lip dry 18.27 10.22 6 142858 15464 63330694
Frequent bowel movements 18.25 10.22 101 142763 22921 63323237
Prescribed underdose 18.24 10.22 24 142840 29665 63316493
Gram stain positive 18.21 10.22 6 142858 42 63346116
Anaesthetic complication cardiac 18.13 10.22 5 142859 17 63346141
Bulimia nervosa 18.11 10.22 12 142852 462 63345696
Paraplegia 18.08 10.22 26 142838 2646 63343512
Joint injury 18.08 10.22 24 142840 29548 63316610
Throat irritation 17.92 10.22 36 142828 37611 63308547
Tumour pain 17.88 10.22 19 142845 1418 63344740
Tryptase increased 17.88 10.22 11 142853 372 63345786
Drug eruption 17.83 10.22 23 142841 28671 63317487
Bronchiectasis 17.80 10.22 7 142857 16135 63330023
Hypertonia 17.80 10.22 35 142829 4602 63341556
Pulmonary congestion 17.73 10.22 82 142782 17336 63328822
Reduced facial expression 17.71 10.22 22 142842 1944 63344214
Manufacturing production issue 17.63 10.22 4 142860 4 63346154
Sinus tachycardia 17.61 10.22 104 142760 24164 63321994
Heavy menstrual bleeding 17.57 10.22 9 142855 17764 63328394
Blood creatine phosphokinase increased 17.53 10.22 123 142741 30307 63315851
Paranoia 17.50 10.22 62 142802 11617 63334541
Posturing 17.49 10.22 12 142852 490 63345668
Pancreatic carcinoma metastatic 17.46 10.22 23 142841 2155 63344003
Myocardial depression 17.44 10.22 12 142852 492 63345666
Decorticate posture 17.42 10.22 10 142854 297 63345861
Limb discomfort 17.28 10.22 25 142839 29691 63316467
Metastatic neoplasm 17.19 10.22 33 142831 4262 63341896
Hypertension 17.09 10.22 488 142376 278815 63067343
Apathy 17.08 10.22 51 142813 8743 63337415
Fungal infection 16.92 10.22 36 142828 36838 63309320
Ankylosing spondylitis 16.91 10.22 57 142807 10417 63335741
Nephrolithiasis 16.86 10.22 44 142820 41940 63304218
Fluid retention 16.81 10.22 73 142791 59613 63286545
Electrocardiogram ST segment elevation 16.75 10.22 31 142833 3896 63342262
Diabetic ketoacidosis 16.68 10.22 13 142851 20492 63325666
Foot deformity 16.62 10.22 23 142841 27830 63318328
Blood pressure immeasurable 16.60 10.22 17 142847 1215 63344943
Documented hypersensitivity to administered product 16.60 10.22 12 142852 533 63345625
Ventricular hypokinesia 16.56 10.22 34 142830 4610 63341548
Injection site rash 16.51 10.22 11 142853 18798 63327360
Vitamin K deficiency 16.48 10.22 11 142853 429 63345729
Caesarean section 16.47 10.22 79 142785 16953 63329205
Breast cancer female 16.47 10.22 5 142859 13554 63332604
Urticaria 16.47 10.22 268 142596 165534 63180624
Therapy interrupted 16.35 10.22 30 142834 32425 63313733
Gaze palsy 16.31 10.22 18 142846 1402 63344756
Muscle spasms 16.31 10.22 250 142614 155900 63190258
Hypothermia 16.16 10.22 67 142797 13514 63332644
Injection site warmth 16.09 10.22 7 142857 15188 63330970
Spinal cord infarction 16.06 10.22 9 142855 255 63345903
Propofol infusion syndrome 15.93 10.22 15 142849 968 63345190
Tooth hypoplasia 15.92 10.22 6 142858 65 63346093
Ileus paralytic 15.86 10.22 33 142831 4518 63341640
Counterfeit product administered 15.83 10.22 5 142859 30 63346128
Mastocytosis 15.82 10.22 12 142852 574 63345584
Deformity 15.80 10.22 60 142804 11624 63334534
Unevaluable event 15.75 10.22 181 142683 51205 63294953
Procedural nausea 15.74 10.22 14 142850 839 63345319
Metastases to meninges 15.71 10.22 24 142840 2578 63343580
Blood glucose increased 15.71 10.22 117 142747 83639 63262519
Tachyphylaxis 15.68 10.22 9 142855 267 63345891
Toxicologic test abnormal 15.68 10.22 13 142851 708 63345450
Decerebrate posture 15.68 10.22 7 142857 120 63346038
Pleural neoplasm 15.67 10.22 10 142854 361 63345797
Productive cough 15.64 10.22 81 142783 63127 63283031
Facet joint syndrome 15.63 10.22 4 142860 12134 63334024
Sneezing 15.53 10.22 11 142853 18207 63327951
Drug-induced liver injury 15.51 10.22 43 142821 40179 63305979
Ileus 15.49 10.22 70 142794 14655 63331503
Septic shock 15.48 10.22 223 142641 66406 63279752
Oral candidiasis 15.47 10.22 96 142768 22702 63323456
Rhabdomyolysis 15.41 10.22 159 142705 43792 63302366
Memory impairment 15.38 10.22 155 142709 104103 63242055
Therapeutic response unexpected 15.34 10.22 83 142781 18676 63327482
Vein disorder 15.32 10.22 35 142829 5106 63341052
Wound dehiscence 15.30 10.22 34 142830 4869 63341289
Peroneal nerve palsy postoperative 15.30 10.22 3 142861 0 63346158
Aortic valve stenosis 15.29 10.22 27 142837 3272 63342886
Gastrointestinal mucosa hyperaemia 15.25 10.22 8 142856 198 63345960
Pelvic fracture 15.22 10.22 65 142799 13283 63332875
Ear pain 15.17 10.22 37 142827 36081 63310077
Autoimmune disorder 15.14 10.22 10 142854 17167 63328991
Oculogyric crisis 15.09 10.22 19 142845 1702 63344456
Nystagmus 14.96 10.22 39 142825 6181 63339977
Muscle tension dysphonia 14.96 10.22 8 142856 206 63345952
Sinus disorder 14.93 10.22 20 142844 24533 63321625
Postmortem blood drug level 14.88 10.22 7 142857 136 63346022
Oxygen saturation immeasurable 14.88 10.22 4 142860 12 63346146
Euthyroid sick syndrome 14.87 10.22 6 142858 79 63346079
Carpal tunnel syndrome 14.77 10.22 15 142849 20802 63325356
Streptococcal sepsis 14.76 10.22 20 142844 1926 63344232
Post laminectomy syndrome 14.69 10.22 9 142855 302 63345856
Substance use 14.69 10.22 11 142853 516 63345642
Cardiac massage 14.64 10.22 4 142860 13 63346145
Atrioventricular dissociation 14.55 10.22 8 142856 218 63345940
Karnofsky scale worsened 14.41 10.22 4 142860 14 63346144
Performance status decreased 14.40 10.22 28 142836 3650 63342508
Procedural vomiting 14.40 10.22 11 142853 532 63345626
Spinal cord compression 14.36 10.22 30 142834 4118 63342040
Coagulation time prolonged 14.34 10.22 17 142847 1431 63344727
Atrioventricular block complete 14.30 10.22 46 142818 8205 63337953
Harlequin syndrome 14.28 10.22 5 142859 43 63346115
Acute hepatic failure 14.26 10.22 80 142784 18247 63327911
Dyspepsia 14.24 10.22 154 142710 102042 63244116
Carbohydrate antigen 15-3 14.22 10.22 6 142858 89 63346069
Panniculitis 14.19 10.22 4 142860 11381 63334777
Foetal heart rate decreased 14.17 10.22 7 142857 152 63346006
Hypersomnia 14.17 10.22 79 142785 17976 63328182
Sinus congestion 14.10 10.22 12 142852 18111 63328047
Oesophageal intramural haematoma 14.10 10.22 6 142858 91 63346067
Carcinoembryonic antigen 14.04 10.22 6 142858 92 63346066
Resuscitation 14.01 10.22 15 142849 1129 63345029
Hypermagnesaemia 14.01 10.22 14 142850 972 63345186
Postnatal growth restriction 13.99 10.22 4 142860 16 63346142
Malaise 13.87 10.22 780 142084 415174 62930984
Tuberculosis 13.86 10.22 4 142860 11207 63334951
Abnormal behaviour 13.78 10.22 89 142775 21337 63324821
Therapy non-responder 13.77 10.22 107 142757 75794 63270364
Procedural haemorrhage 13.77 10.22 23 142841 2665 63343493
Vasoplegia syndrome 13.71 10.22 18 142846 1681 63344477
Torsade de pointes 13.70 10.22 63 142801 13288 63332870
Orthostatic hypotension 13.69 10.22 39 142825 36121 63310037
Hypotonia 13.66 10.22 49 142815 9236 63336922
Gastric disorder 13.65 10.22 41 142823 37328 63308830
Bezold-Jarisch reflex 13.62 10.22 4 142860 18 63346140
Impaired quality of life 13.60 10.22 7 142857 13776 63332382
Pneumonia aspiration 13.59 10.22 128 142736 34412 63311746
Intensive care unit delirium 13.53 10.22 5 142859 51 63346107
Balance disorder 13.52 10.22 123 142741 84299 63261859
Intervertebral disc compression 13.44 10.22 15 142849 1183 63344975
Air embolism 13.37 10.22 8 142856 257 63345901
Self-medication 13.31 10.22 23 142841 2740 63343418
Neurosis 13.29 10.22 8 142856 260 63345898
Dermal absorption impaired 13.28 10.22 5 142859 54 63346104
Systemic inflammatory response syndrome 13.27 10.22 35 142829 5586 63340572
Acute lung injury 13.23 10.22 17 142847 1554 63344604
Nerve stimulation test abnormal 13.22 10.22 3 142861 3 63346155
Brain herniation 13.21 10.22 27 142837 3650 63342508
Eye pain 13.20 10.22 36 142828 33818 63312340
Conversion disorder 13.18 10.22 18 142846 1746 63344412
Sensitivity to weather change 13.14 10.22 41 142823 7196 63338962
Psychomotor skills impaired 13.13 10.22 21 142843 2347 63343811
Leukoencephalopathy 13.10 10.22 30 142834 4383 63341775
Eye swelling 13.06 10.22 21 142843 23897 63322261
Joint range of motion decreased 13.01 10.22 34 142830 32394 63313764
Sopor 13.01 10.22 90 142774 22074 63324084
Implant site extravasation 12.99 10.22 10 142854 489 63345669
Cardiac failure congestive 12.99 10.22 139 142725 92294 63253864
Product administered to patient of inappropriate age 12.95 10.22 25 142839 3243 63342915
Yawning 12.95 10.22 14 142850 1066 63345092
Dry skin 12.92 10.22 75 142789 56812 63289346
Dermatitis atopic 12.92 10.22 3 142861 9721 63336437
Blood pressure systolic abnormal 12.91 10.22 7 142857 13379 63332779
Laryngeal oedema 12.89 10.22 35 142829 5683 63340475
Anuria 12.71 10.22 59 142805 12492 63333666
Osteomyelitis 12.63 10.22 101 142763 25919 63320239
Blood ethanol increased 12.60 10.22 6 142858 120 63346038
Decubitus ulcer 12.60 10.22 52 142812 10468 63335690
Blood creatinine decreased 12.56 10.22 34 142830 5511 63340647
Uterine atony 12.53 10.22 7 142857 197 63345961
Sputum discoloured 12.51 10.22 11 142853 16336 63329822
Substance use disorder 12.44 10.22 7 142857 200 63345958
Intestinal ischaemia 12.38 10.22 41 142823 7427 63338731
Laryngeal obstruction 12.38 10.22 6 142858 125 63346033
Somatosensory evoked potentials abnormal 12.37 10.22 3 142861 5 63346153
Metastatic malignant melanoma 12.31 10.22 15 142849 1300 63344858
Acute chest syndrome 12.30 10.22 12 142852 809 63345349
Laryngitis 12.29 10.22 12 142852 16955 63329203
Hemianopia homonymous 12.26 10.22 11 142853 667 63345491
Hypoaesthesia 12.21 10.22 287 142577 168106 63178052
Colitis microscopic 12.18 10.22 3 142861 9336 63336822
Cranial nerve disorder 12.05 10.22 10 142854 545 63345613
Malnutrition 12.05 10.22 67 142797 15231 63330927
Lumbosacral plexopathy 12.02 10.22 3 142861 6 63346152
Foreign body 11.97 10.22 20 142844 2318 63343840
Rash pruritic 11.96 10.22 82 142782 59717 63286441
Shock 11.89 10.22 92 142772 23371 63322787
Pancreatic carcinoma 11.87 10.22 41 142823 7587 63338571
Complex regional pain syndrome 11.85 10.22 20 142844 2337 63343821
Blood albumin decreased 11.85 10.22 65 142799 14701 63331457
Pleural effusion 11.84 10.22 284 142580 92926 63253232
Periorbital cellulitis 11.78 10.22 11 142853 702 63345456
Procedural pain 11.74 10.22 86 142778 21483 63324675
Product formulation issue 11.70 10.22 10 142854 568 63345590
Gamma-glutamyltransferase 11.68 10.22 4 142860 32 63346126
Lower limb fracture 11.66 10.22 23 142841 24198 63321960
Ventricular dysfunction 11.65 10.22 22 142842 2806 63343352
Middle insomnia 11.64 10.22 7 142857 12636 63333522
Eye pruritus 11.57 10.22 15 142849 18656 63327502
Disseminated intravascular coagulation 11.56 10.22 78 142786 18973 63327185
Visceral congestion 11.54 10.22 8 142856 332 63345826
Stupor 11.54 10.22 28 142836 4247 63341911
Irregular breathing 11.38 10.22 8 142856 340 63345818
Septic pulmonary embolism 11.34 10.22 5 142859 83 63346075
Burkholderia test positive 11.34 10.22 7 142857 238 63345920
Joint effusion 11.31 10.22 13 142851 17047 63329111
Infection parasitic 11.31 10.22 8 142856 343 63345815
Dysaesthesia pharynx 11.31 10.22 6 142858 152 63346006
Multiple lentigines syndrome 11.31 10.22 6 142858 152 63346006
Creatinine renal clearance decreased 11.29 10.22 12 142852 16296 63329862
Chorea 11.28 10.22 16 142848 1608 63344550
Swelling face 11.28 10.22 90 142774 63385 63282773
Laryngeal stenosis 11.25 10.22 13 142851 1065 63345093
Feeling cold 11.20 10.22 92 142772 23796 63322362
Cancer fatigue 11.18 10.22 5 142859 86 63346072
Central-alveolar hypoventilation 11.16 10.22 3 142861 9 63346149
Application site laceration 11.16 10.22 3 142861 9 63346149
Hypobarism 11.16 10.22 3 142861 9 63346149
Excessive dynamic airway collapse 11.16 10.22 3 142861 9 63346149
Obstetric procedure complication 11.16 10.22 3 142861 9 63346149
Prinzmetal angina 11.14 10.22 11 142853 753 63345405
Respiratory alkalosis 11.12 10.22 21 142843 2680 63343478
Device issue 11.09 10.22 23 142841 23758 63322400
Vision blurred 11.08 10.22 143 142721 91781 63254377
Premature separation of placenta 11.01 10.22 17 142847 1844 63344314
Chest expansion decreased 10.98 10.22 4 142860 39 63346119
Illness 10.97 10.22 65 142799 48994 63297164
Food allergy 10.94 10.22 6 142858 11395 63334763
Lagophthalmos 10.93 10.22 8 142856 362 63345796
Metastatic gastric cancer 10.90 10.22 6 142858 164 63345994
Paroxysmal arrhythmia 10.89 10.22 4 142860 40 63346118
Hyperkalaemia 10.89 10.22 177 142687 54026 63292132
Cytomegalovirus infection 10.88 10.22 19 142845 20933 63325225
Status epilepticus 10.87 10.22 65 142799 15168 63330990
Dislocation of vertebra 10.83 10.22 3 142861 8632 63337526
Gastrointestinal vascular malformation 10.81 10.22 4 142860 41 63346117
Seizure 10.76 10.22 382 142482 132252 63213906
Lung disorder 10.73 10.22 89 142775 62172 63283986
Taste disorder 10.69 10.22 9 142855 13653 63332505
Perfume sensitivity 10.65 10.22 11 142853 794 63345364
Metabolic encephalopathy 10.63 10.22 33 142831 5776 63340382
Pulmonary toxicity 10.59 10.22 4 142860 9451 63336707
Pneumocephalus 10.58 10.22 6 142858 174 63345984
Incontinence 10.57 10.22 53 142811 11579 63334579
Extradural haematoma 10.57 10.22 16 142848 1706 63344452
Colon cancer metastatic 10.56 10.22 13 142851 1138 63345020
Eosinophil cationic protein increased 10.56 10.22 4 142860 44 63346114
Acne 10.47 10.22 23 142841 23270 63322888
Foot fracture 10.44 10.22 24 142840 23890 63322268
Sinus arrest 10.42 10.22 17 142847 1932 63344226
Sequestrectomy 10.42 10.22 11 142853 815 63345343
Head and neck cancer 10.40 10.22 4 142860 46 63346112
Hyperdynamic left ventricle 10.40 10.22 6 142858 180 63345978
Shock haemorrhagic 10.38 10.22 47 142817 9848 63336310
Product storage error 10.36 10.22 11 142853 14945 63331213
Adjustment disorder with depressed mood 10.34 10.22 5 142859 10199 63335959
Embolic cerebral infarction 10.34 10.22 9 142855 524 63345634
Pseudomonal sepsis 10.30 10.22 19 142845 2382 63343776
Depressed mood 10.23 10.22 51 142813 40140 63306018

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 9364.54 10.97 5075 108003 94021 34749832
Toxicity to various agents 2479.33 10.97 3133 109945 197229 34646624
Respiratory arrest 863.99 10.97 720 112358 27323 34816530
Cardio-respiratory arrest 693.83 10.97 874 112204 54399 34789454
Cardiac arrest 682.39 10.97 1161 111917 94998 34748855
Overdose 661.42 10.97 1111 111967 89948 34753905
Respiratory depression 655.16 10.97 489 112589 15756 34828097
Accidental overdose 626.19 10.97 520 112558 19620 34824233
Incorrect route of product administration 612.40 10.97 453 112625 14392 34829461
Product adhesion issue 584.16 10.97 213 112865 1387 34842466
Serotonin syndrome 536.79 10.97 474 112604 19459 34824394
Prescription drug used without a prescription 432.02 10.97 186 112892 1968 34841885
Drug withdrawal syndrome 400.37 10.97 402 112676 19432 34824421
Intentional product misuse 331.23 10.97 557 112521 45054 34798799
Drug dependence 295.66 10.97 378 112700 23839 34820014
Unresponsive to stimuli 291.44 10.97 401 112677 27168 34816685
Hyperthermia malignant 279.72 10.97 138 112940 2039 34841814
Miosis 279.35 10.97 238 112840 9297 34834556
Depressed level of consciousness 260.41 10.97 484 112594 42357 34801496
Death 251.07 10.97 2165 110913 395884 34447969
Anaphylactic reaction 215.45 10.97 380 112698 31921 34811932
Hyperaesthesia 199.23 10.97 145 112933 4485 34839368
Inadequate analgesia 197.54 10.97 122 112956 2853 34841000
Accidental exposure to product by child 196.91 10.97 96 112982 1380 34842473
Pulmonary oedema 170.48 10.97 434 112644 47095 34796758
Product quality issue 162.54 10.97 236 112842 16799 34827054
Drug use disorder 157.46 10.97 121 112957 4070 34839783
Delirium 157.04 10.97 401 112677 43590 34800263
Amnestic disorder 140.52 10.97 46 113032 205 34843648
Withdrawal syndrome 132.82 10.97 182 112896 12273 34831580
Somnolence 131.25 10.97 707 112371 110409 34733444
Anaesthetic complication 129.20 10.97 66 113012 1054 34842799
Delayed recovery from anaesthesia 121.79 10.97 57 113021 744 34843109
Brain oedema 118.29 10.97 182 112896 13639 34830214
Headache 113.46 10.97 306 112772 200329 34643524
Apnoea 112.81 10.97 123 112955 6541 34837312
Arthralgia 110.60 10.97 241 112837 169800 34674053
Neuromuscular block prolonged 109.54 10.97 46 113032 455 34843398
Injury 108.86 10.97 220 112858 20467 34823386
Wrong technique in product usage process 107.28 10.97 307 112771 35679 34808174
Bradypnoea 106.99 10.97 82 112996 2747 34841106
Malignant neoplasm progression 105.81 10.97 563 112515 87483 34756370
Off label use 103.14 10.97 866 112212 418658 34425195
Pruritus 102.79 10.97 189 112889 141792 34702061
Neoplasm progression 102.08 10.97 230 112848 23070 34820783
Diarrhoea 96.64 10.97 803 112275 389109 34454744
Cough 94.98 10.97 216 112862 149924 34693929
Respiratory acidosis 93.94 10.97 98 112980 4952 34838901
Product prescribing error 93.48 10.97 220 112858 22707 34821146
Product complaint 93.29 10.97 105 112973 5785 34838068
Rash 92.87 10.97 388 112690 222364 34621489
Fear 92.54 10.97 140 112938 10336 34833517
Propofol infusion syndrome 91.77 10.97 50 113028 916 34842937
Hypotension 82.92 10.97 1087 111991 220562 34623291
Hypercapnia 81.72 10.97 84 112994 4171 34839682
Brain injury 81.50 10.97 100 112978 6042 34837811
Coma 80.66 10.97 327 112751 45351 34798502
Respiratory rate decreased 79.75 10.97 64 113014 2295 34841558
Counterfeit product administered 77.92 10.97 27 113051 148 34843705
Treatment failure 77.63 10.97 27 113051 46670 34797183
Product dose omission issue 76.68 10.97 171 112907 119540 34724313
Drug diversion 76.65 10.97 43 113035 836 34843017
Drug abuser 75.84 10.97 78 113000 3876 34839977
Anaphylactic shock 75.07 10.97 162 112916 15779 34828074
Sedation complication 74.97 10.97 55 113023 1722 34842131
Muscle rigidity 73.02 10.97 126 112952 10392 34833461
Intensive care unit acquired weakness 73.01 10.97 44 113034 983 34842870
Bradycardia 72.13 10.97 454 112624 74964 34768889
Fatigue 71.98 10.97 810 112268 369843 34474010
Drug interaction 71.56 10.97 1076 112002 224870 34618983
Cardiac failure congestive 71.40 10.97 99 112979 83171 34760682
Myoclonus 70.90 10.97 151 112927 14574 34829279
Myalgia 70.13 10.97 102 112976 84008 34759845
Impaired driving ability 69.60 10.97 62 113016 2571 34841282
Weight increased 68.93 10.97 122 112956 92911 34750942
Anhedonia 67.90 10.97 102 112976 7483 34836370
Peripheral swelling 67.64 10.97 89 112989 76452 34767401
COVID-19 66.68 10.97 92 112986 77458 34766395
Emotional distress 65.44 10.97 148 112930 14878 34828975
Nasopharyngitis 65.34 10.97 78 113000 69890 34773963
Renal injury 64.87 10.97 124 112954 11071 34832782
Post procedural complication 64.60 10.97 125 112953 11263 34832590
Hypoxia 63.90 10.97 349 112729 54746 34789107
Opiates positive 63.45 10.97 33 113045 548 34843305
Narcotic bowel syndrome 63.43 10.97 22 113056 121 34843732
Pulseless electrical activity 61.76 10.97 95 112983 7116 34836737
Procedural hypotension 61.16 10.97 38 113040 898 34842955
Asthma 60.75 10.97 31 113047 42625 34801228
Product counterfeit 60.75 10.97 22 113056 140 34843713
Dyspnoea exertional 59.36 10.97 33 113045 43246 34800607
Cyanosis 55.90 10.97 126 112952 12638 34831215
Procedural complication 55.65 10.97 69 113009 4214 34839639
Dyspnoea 53.69 10.97 877 112201 375905 34467948
Spinal muscular atrophy 53.56 10.97 26 113052 370 34843483
Diabetes insipidus 53.00 10.97 56 113022 2872 34840981
Coronary artery disease 52.85 10.97 47 113031 48258 34795595
Myocardial infarction 52.82 10.97 207 112871 120878 34722975
Blood glucose increased 52.63 10.97 84 112994 66634 34777219
Infusion related reaction 51.86 10.97 57 113021 53000 34790853
Blood cholesterol increased 51.23 10.97 4 113074 20539 34823314
Bronchospasm 50.46 10.97 109 112969 10622 34833231
Tachycardia 50.27 10.97 456 112622 84316 34759537
Sinusitis 49.37 10.97 37 113041 41365 34802488
Confusional state 49.28 10.97 696 112382 143464 34700389
Syncope 48.98 10.97 143 112935 91308 34752545
Tachypnoea 48.44 10.97 150 112928 18202 34825651
Agitation 47.88 10.97 334 112744 57065 34786788
Medication error 47.51 10.97 186 112892 25379 34818474
Dizziness 47.38 10.97 465 112613 218056 34625797
Rheumatoid arthritis 47.13 10.97 33 113045 38205 34805648
Hypoxic-ischaemic encephalopathy 46.47 10.97 65 113013 4467 34839386
Laryngospasm 44.61 10.97 38 113040 1483 34842370
Brain death 44.50 10.97 49 113029 2634 34841219
Anion gap 43.91 10.97 30 113048 837 34843016
Oxygen saturation decreased 43.62 10.97 311 112767 53507 34790346
Psoriasis 43.38 10.97 37 113041 38775 34805078
Application site reaction 43.17 10.97 23 113055 402 34843451
Tryptase increased 42.76 10.97 19 113059 218 34843635
Exposure to toxic agent 42.69 10.97 56 113022 3619 34840234
Respiratory failure 41.53 10.97 535 112543 108037 34735816
Compartment syndrome 41.44 10.97 50 113028 2968 34840885
Increased bronchial secretion 41.41 10.97 40 113038 1841 34842012
Pain in extremity 41.29 10.97 240 112838 126273 34717580
Blood pressure measurement 40.94 10.97 17 113061 163 34843690
Stress cardiomyopathy 40.18 10.97 41 113037 2018 34841835
Pain 39.89 10.97 904 112174 203771 34640082
Negative pressure pulmonary oedema 39.87 10.97 18 113060 215 34843638
Neuropathy peripheral 39.81 10.97 137 112941 83126 34760727
Chest discomfort 39.04 10.97 73 113005 54457 34789396
Pneumococcal sepsis 38.76 10.97 31 113047 1106 34842747
Abdominal discomfort 38.66 10.97 85 112993 59750 34784103
Hypoglycaemia 38.37 10.97 74 113004 54566 34789287
Drug resistance 38.19 10.97 18 113060 25909 34817944
Diabetes mellitus 37.93 10.97 58 113020 46815 34797038
Anterograde amnesia 37.86 10.97 16 113062 161 34843692
Febrile neutropenia 37.85 10.97 273 112805 136576 34707277
Malaise 37.55 10.97 402 112676 185423 34658430
Metabolic acidosis 37.50 10.97 256 112822 43424 34800429
Angina pectoris 37.43 10.97 28 113050 31335 34812518
Product use in unapproved indication 37.23 10.97 225 112853 117274 34726579
Joint swelling 37.13 10.97 87 112991 59803 34784050
Poisoning 37.09 10.97 105 112973 12121 34831732
Cerebrovascular accident 36.96 10.97 145 112933 84666 34759187
Drug screen positive 36.69 10.97 54 113024 3889 34839964
Therapy naive 36.48 10.97 11 113067 35 34843818
Airway complication of anaesthesia 36.29 10.97 15 113063 142 34843711
Anaesthetic complication neurological 36.29 10.97 19 113059 320 34843533
Haemodynamic instability 36.25 10.97 89 112989 9434 34834419
Cardiac failure 36.06 10.97 162 112916 91086 34752767
Eosinophilia 35.94 10.97 20 113058 26202 34817651
Accidental death 35.89 10.97 42 113036 2414 34841439
Pyrexia 35.75 10.97 813 112265 332200 34511653
Pelvic pain 35.56 10.97 42 113036 2438 34841415
Sedation 35.19 10.97 148 112930 20858 34822995
Amphetamines positive 34.45 10.97 16 113062 205 34843648
Cytomegalovirus infection 34.31 10.97 21 113057 26114 34817739
Coma blister 34.30 10.97 12 113066 68 34843785
Influenza 34.23 10.97 68 113010 49598 34794255
Recurrence of neuromuscular blockade 34.17 10.97 16 113062 209 34843644
Drug detoxification 34.05 10.97 17 113061 258 34843595
Stoma closure 33.81 10.97 17 113061 262 34843591
Injection site pain 33.79 10.97 46 113032 38959 34804894
Unevaluable event 33.53 10.97 200 112878 32390 34811463
Basal cell carcinoma 33.30 10.97 11 113067 19647 34824206
Blood pressure increased 33.28 10.97 159 112919 87943 34755910
Disorientation 33.08 10.97 202 112876 32986 34810867
Acute lung injury 33.04 10.97 32 113046 1478 34842375
Nephrolithiasis 32.59 10.97 30 113048 30303 34813550
Blood pressure decreased 32.53 10.97 281 112797 51234 34792619
Arthritis 32.51 10.97 32 113046 31314 34812539
Fall 32.28 10.97 462 112616 202423 34641430
Hyperthermia 32.25 10.97 91 112987 10486 34833367
Pulmonary congestion 32.24 10.97 108 112970 13657 34830196
Resuscitation 32.18 10.97 31 113047 1422 34842431
Drug tolerance 32.06 10.97 43 113035 2839 34841014
Cachexia 31.53 10.97 71 113007 7115 34836738
Gastrointestinal haemorrhage 31.51 10.97 163 112915 88314 34755539
Autonomic nervous system imbalance 31.39 10.97 40 113038 2511 34841342
Upper airway obstruction 31.30 10.97 22 113056 643 34843210
Oedema peripheral 30.75 10.97 244 112834 119568 34724285
Intestinal pseudo-obstruction 30.75 10.97 33 113045 1723 34842130
Diabetic ketoacidosis 30.71 10.97 10 113068 18022 34825831
Hypoventilation 30.68 10.97 46 113032 3368 34840485
Application site rash 30.58 10.97 24 113054 833 34843020
Clonus 30.55 10.97 41 113037 2709 34841144
Tachyphylaxis 30.48 10.97 13 113065 134 34843719
Oxygen saturation immeasurable 30.24 10.97 9 113069 27 34843826
Trigemino-cardiac reflex 30.17 10.97 14 113064 179 34843674
Postoperative ileus 30.07 10.97 22 113056 686 34843167
Therapeutic product effect increased 29.93 10.97 22 113056 691 34843162
Urinary tract infection 29.89 10.97 155 112923 83926 34759927
Acute respiratory distress syndrome 29.75 10.97 164 112914 25805 34818048
Breakthrough pain 29.24 10.97 20 113058 559 34843294
Haemoglobin decreased 29.16 10.97 250 112828 120522 34723331
Coma scale abnormal 29.12 10.97 49 113029 3959 34839894
Loss of personal independence in daily activities 28.87 10.97 39 113039 33140 34810713
Transient ischaemic attack 28.86 10.97 28 113050 27585 34816268
Motor neurone disease 28.85 10.97 19 113059 498 34843355
Acute motor axonal neuropathy 28.83 10.97 10 113068 55 34843798
Accidental exposure to product 28.71 10.97 99 112979 12703 34831150
Rectal haemorrhage 28.70 10.97 54 113024 40195 34803658
Lymphadenectomy 28.60 10.97 17 113061 370 34843483
Gait disturbance 28.58 10.97 160 112918 84980 34758873
International normalised ratio increased 28.35 10.97 70 113008 47257 34796596
Suicide attempt 28.32 10.97 52 113026 39064 34804789
Toxic leukoencephalopathy 27.85 10.97 17 113061 389 34843464
Tooth loss 27.81 10.97 47 113031 3811 34840042
Epistaxis 27.73 10.97 96 112982 58155 34785698
Post procedural hypotension 27.43 10.97 10 113068 65 34843788
Herpes zoster 27.41 10.97 43 113035 34356 34809497
Drug withdrawal syndrome neonatal 27.30 10.97 45 113033 3574 34840279
White blood cell count decreased 27.05 10.97 189 112889 95256 34748597
Conversion disorder 27.01 10.97 16 113062 346 34843507
Seizure like phenomena 26.41 10.97 21 113057 743 34843110
Atrial fibrillation 26.24 10.97 261 112817 122132 34721721
Myocardial stunning 26.21 10.97 7 113071 12 34843841
Accidental poisoning 25.79 10.97 21 113057 769 34843084
Acidosis 25.74 10.97 86 112992 10859 34832994
Completed suicide 25.56 10.97 453 112625 97715 34746138
Circulatory collapse 25.55 10.97 135 112943 20903 34822950
Type 2 diabetes mellitus 25.41 10.97 10 113068 16022 34827831
Palpitations 24.85 10.97 58 113020 39928 34803925
Constipation 24.78 10.97 599 112479 136383 34707470
Mental status changes 24.70 10.97 209 112869 37874 34805979
Thermophobia 24.62 10.97 9 113069 59 34843794
Platelet count decreased 24.55 10.97 258 112820 119459 34724394
Full blood count abnormal 24.51 10.97 15 113063 18653 34825200
Endotracheal intubation 24.33 10.97 39 113039 3026 34840827
Postmortem blood drug level abnormal 24.30 10.97 14 113064 287 34843566
Therapeutic product effect incomplete 24.25 10.97 83 112995 50458 34793395
Musculoskeletal stiffness 24.25 10.97 74 113004 46606 34797247
Oculocardiac reflex 24.25 10.97 9 113069 62 34843791
Hypogonadism 24.11 10.97 33 113045 2222 34841631
Presyncope 24.08 10.97 16 113062 19043 34824810
Substance use 23.83 10.97 19 113059 675 34843178
Postmortem blood drug level increased 23.72 10.97 13 113065 241 34843612
Self-medication 23.69 10.97 36 113042 2667 34841186
Methaemoglobinaemia 23.69 10.97 42 113036 3539 34840314
Hyperhidrosis 23.68 10.97 360 112718 75332 34768521
Foetal exposure during delivery 23.54 10.97 10 113068 102 34843751
Paraesthesia 23.54 10.97 117 112961 64055 34779798
Neutropenia 23.53 10.97 361 112717 156417 34687436
Application site pruritus 23.41 10.97 26 113052 1411 34842442
Intentional product use issue 23.38 10.97 296 112782 59520 34784333
Electrocardiogram ST segment elevation 23.26 10.97 52 113026 5186 34838667
Lethargy 23.24 10.97 219 112859 40903 34802950
Drug-induced liver injury 23.01 10.97 36 113042 28796 34815057
Upper respiratory tract infection 23.00 10.97 45 113033 33014 34810839
Metastases to bone 22.98 10.97 88 112990 11882 34831971
Sinus tachycardia 22.89 10.97 114 112964 17246 34826607
Sputum increased 22.84 10.97 33 113045 2337 34841516
Product administered at inappropriate site 22.82 10.97 32 113046 2204 34841649
Agranulocytosis 22.82 10.97 26 113052 23795 34820058
Arteriospasm coronary 22.80 10.97 40 113038 3342 34840511
Blood pressure fluctuation 22.66 10.97 29 113049 25220 34818633
Visual acuity reduced 22.60 10.97 12 113066 16137 34827716
Eczema 22.59 10.97 16 113062 18420 34825433
Sinus arrest 22.55 10.97 28 113050 1712 34842141
Influenza like illness 22.54 10.97 34 113044 27600 34816253
Posthaemorrhagic hydrocephalus 22.41 10.97 10 113068 116 34843737
Dry skin 22.28 10.97 42 113036 31245 34812608
Lower respiratory tract infection bacterial 22.26 10.97 16 113062 485 34843368
Melaena 22.24 10.97 51 113027 35329 34808524
Systolic anterior motion of mitral valve 22.18 10.97 7 113071 27 34843826
Bronchitis 22.17 10.97 66 113012 41897 34801956
Skin exfoliation 22.13 10.97 34 113044 27398 34816455
Lower respiratory tract infection 22.07 10.97 43 113035 31594 34812259
Myelosuppression 21.97 10.97 18 113060 19247 34824606
Application site hypersensitivity 21.89 10.97 10 113068 123 34843730
Anaesthetic complication pulmonary 21.87 10.97 6 113072 12 34843841
Plasma cell myeloma 21.86 10.97 220 112858 41817 34802036
Erectile dysfunction 21.48 10.97 21 113057 20616 34823237
Hyponatraemia 21.39 10.97 168 112910 82523 34761330
Sciatic nerve neuropathy 21.20 10.97 8 113070 58 34843795
Bladder dilatation 20.95 10.97 25 113053 1467 34842386
Psoriatic arthropathy 20.78 10.97 20 113058 19778 34824075
Condition aggravated 20.62 10.97 469 112609 191727 34652126
Disease complication 20.61 10.97 34 113044 2702 34841151
Sleep disorder 20.47 10.97 45 113033 31643 34812210
Erythema 20.44 10.97 186 112892 88594 34755259
Paraplegia 20.37 10.97 35 113043 2876 34840977
Migraine 20.35 10.97 16 113062 17462 34826391
Bone marrow failure 20.20 10.97 40 113038 29213 34814640
Misleading laboratory test result 20.16 10.97 6 113072 18 34843835
Fluid retention 20.13 10.97 35 113043 26852 34817001
Hyperlipidaemia 20.03 10.97 11 113067 14518 34829335
Leukoencephalopathy 20.03 10.97 43 113035 4172 34839681
Application site dermatitis 19.96 10.97 7 113071 40 34843813
Glycosylated haemoglobin increased 19.88 10.97 6 113072 11354 34832499
Pulse absent 19.76 10.97 52 113026 5751 34838102
Prostate cancer metastatic 19.76 10.97 52 113026 5751 34838102
Cataract 19.68 10.97 34 113044 26152 34817701
Intercepted product dispensing error 19.61 10.97 8 113070 73 34843780
Therapy interrupted 19.43 10.97 10 113068 13687 34830166
Ischaemic cerebral infarction 19.36 10.97 22 113056 1225 34842628
Burkholderia test positive 19.29 10.97 20 113058 1003 34842850
Wheezing 19.19 10.97 69 113009 41333 34802520
Hypercapnic coma 19.18 10.97 10 113068 167 34843686
Vision blurred 19.12 10.97 80 112998 45883 34797970
Systemic infection 19.09 10.97 48 113030 5164 34838689
Dependence 19.07 10.97 21 113057 1129 34842724
Coma neonatal 19.04 10.97 6 113072 23 34843830
Hypotonic-hyporesponsive episode 19.04 10.97 6 113072 23 34843830
Poor quality product administered 19.03 10.97 27 113051 1880 34841973
Drug screen negative 19.02 10.97 10 113068 170 34843683
Pancreatitis acute 18.98 10.97 39 113039 28102 34815751
Disease recurrence 18.96 10.97 25 113053 21465 34822388
Bronchial disorder 18.87 10.97 23 113055 1380 34842473
Substance abuse 18.83 10.97 61 113017 7580 34836273
Polyneuropathy in malignant disease 18.73 10.97 11 113067 234 34843619
Chronic obstructive pulmonary disease 18.63 10.97 88 112990 48830 34795023
Endotracheal intubation complication 18.62 10.97 13 113065 376 34843477
Device failure 18.54 10.97 30 113048 2346 34841507
Rash pruritic 18.46 10.97 37 113041 26904 34816949
Injection site bruising 18.32 10.97 3 113075 8660 34835193
Pneumonitis chemical 18.31 10.97 10 113068 184 34843669
Chest pain 18.30 10.97 294 112784 126468 34717385
Ventricular arrhythmia 18.28 10.97 49 113029 5479 34838374
Postoperative respiratory distress 18.23 10.97 5 113073 10 34843843
Blood catecholamines increased 18.23 10.97 5 113073 10 34843843
Tuberculosis 18.07 10.97 3 113075 8574 34835279
Postmortem blood drug level 17.98 10.97 10 113068 191 34843662
Appendicitis 17.95 10.97 13 113065 14794 34829059
Pancytopenia 17.94 10.97 209 112869 94948 34748905
Anaemia 17.89 10.97 597 112481 232738 34611115
Terminal insomnia 17.88 10.97 15 113063 573 34843280
Drug intolerance 17.85 10.97 116 112962 59454 34784399
Photosensitivity reaction 17.82 10.97 6 113072 10588 34833265
Asthenia 17.76 10.97 632 112446 244619 34599234
Application site irritation 17.65 10.97 16 113062 679 34843174
Neonatal respiratory depression 17.58 10.97 13 113065 412 34843441
Tendonitis 17.57 10.97 4 113074 9136 34834717
Urinary retention 17.48 10.97 187 112891 36101 34807752
Motor dysfunction 17.48 10.97 56 113022 6918 34836935
Eye pain 17.42 10.97 11 113067 13451 34830402
Injection site haemorrhage 17.38 10.97 5 113073 9763 34834090
Progressive multifocal leukoencephalopathy 17.37 10.97 5 113073 9759 34834094
Sweat gland disorder 17.33 10.97 8 113070 101 34843752
Torsade de pointes 17.27 10.97 57 113021 7152 34836701
Kounis syndrome 17.26 10.97 30 113048 2488 34841365
Product packaging quantity issue 17.23 10.97 18 113060 911 34842942
Viral infection 17.14 10.97 19 113059 17604 34826249
Product contamination 17.13 10.97 16 113062 706 34843147
Rash maculo-papular 17.10 10.97 42 113036 28409 34815444
Leukopenia 17.06 10.97 126 112952 62730 34781123
Allodynia 17.04 10.97 17 113061 814 34843039
Cytopenia 17.01 10.97 10 113068 12713 34831140
Cerebral ischaemia 16.98 10.97 52 113026 6270 34837583
Anal inflammation 16.98 10.97 21 113057 1279 34842574
Injection site swelling 16.98 10.97 8 113070 11519 34832334
Haematotoxicity 16.97 10.97 3 113075 8191 34835662
Environmental exposure 16.95 10.97 11 113067 281 34843572
Squamous cell carcinoma of skin 16.90 10.97 7 113071 10874 34832979
Abdominal compartment syndrome 16.85 10.97 18 113060 935 34842918
Multiple organ dysfunction syndrome 16.73 10.97 344 112734 76222 34767631
Gynaecomastia 16.72 10.97 6 113072 10174 34833679
Hypopnoea 16.65 10.97 28 113050 2261 34841592
Spinal cord infarction 16.58 10.97 11 113067 292 34843561
Oropharyngeal pain 16.53 10.97 59 113019 35426 34808427
Product packaging issue 16.50 10.97 15 113063 639 34843214
Weight bearing difficulty 16.46 10.97 19 113059 1076 34842777
Electrocardiogram ST segment depression 16.39 10.97 29 113049 2439 34841414
Acute myeloid leukaemia 16.38 10.97 21 113057 18249 34825604
Nasal congestion 16.38 10.97 31 113047 23026 34820827
Visual impairment 16.37 10.97 60 113018 35742 34808111
Non-cardiogenic pulmonary oedema 16.36 10.97 15 113063 646 34843207
Haematuria 16.30 10.97 95 112983 49971 34793882
Thrombosis 16.29 10.97 96 112982 50362 34793491
Drug tolerance increased 16.27 10.97 13 113065 463 34843390
Metabolic disorder 16.27 10.97 40 113038 4243 34839610
Swelling 16.25 10.97 76 113002 42290 34801563
Blood ethanol 16.10 10.97 8 113070 120 34843733
Diabetes mellitus inadequate control 16.09 10.97 12 113066 13452 34830401
Spinal cord compression 16.04 10.97 38 113040 3937 34839916
Hyperventilation 16.02 10.97 31 113047 2793 34841060
Acute kidney injury 16.00 10.97 815 112263 304173 34539680
Localised infection 15.99 10.97 20 113058 17567 34826286
Pulmonary alveolar haemorrhage 15.90 10.97 57 113021 7455 34836398
Hypermagnesaemia 15.81 10.97 10 113068 244 34843609
Pneumonia aspiration 15.79 10.97 206 112872 41697 34802156
Paralysis recurrent laryngeal nerve 15.73 10.97 6 113072 45 34843808
Electrocardiogram T wave alternans 15.70 10.97 5 113073 20 34843833
Anal stenosis 15.47 10.97 9 113069 188 34843665
Asphyxia 15.45 10.97 53 113025 6782 34837071
Acute myocardial infarction 15.40 10.97 106 112972 53613 34790240
Apnoeic attack 15.35 10.97 12 113066 414 34843439
Neuromuscular blockade 15.32 10.97 10 113068 258 34843595
Blood pressure systolic increased 15.32 10.97 32 113046 22920 34820933
Multiple sclerosis relapse 15.32 10.97 12 113066 13121 34830732
Hypoperfusion 15.27 10.97 19 113059 1164 34842689
Air embolism 15.27 10.97 8 113070 135 34843718
Vasoplegia syndrome 15.26 10.97 24 113054 1832 34842021
Urinary bladder rupture 15.26 10.97 7 113071 87 34843766
Oesophagitis ulcerative 15.23 10.97 16 113062 815 34843038
Ear infection 15.22 10.97 7 113071 10224 34833629
Tubulointerstitial nephritis 15.17 10.97 28 113050 20996 34822857
Product tampering 15.08 10.97 6 113072 51 34843802
Hepatic enzyme increased 15.05 10.97 70 113008 39010 34804843
Scoliosis 15.04 10.97 30 113048 2763 34841090
Eye pruritus 14.96 10.97 3 113075 7486 34836367
Dyslipidaemia 14.96 10.97 3 113075 7485 34836368
Vomiting 14.94 10.97 960 112118 246661 34597192
Knee arthroplasty 14.83 10.97 3 113075 7441 34836412
Dental caries 14.77 10.97 40 113038 4499 34839354
Cancer pain 14.75 10.97 29 113049 2643 34841210
Contusion 14.69 10.97 64 113014 36300 34807553
Respiratory tract infection bacterial 14.59 10.97 23 113055 1759 34842094
Gastrooesophageal reflux disease 14.57 10.97 68 113010 37856 34805997
Dyskinesia 14.53 10.97 123 112955 22290 34821563
Preternatural anus 14.52 10.97 7 113071 98 34843755
Loss of consciousness 14.48 10.97 360 112718 82307 34761546
Drug ineffective 14.44 10.97 1277 111801 455474 34388379
Productive cough 14.41 10.97 68 113010 37745 34806108
Large intestine anastomosis 14.41 10.97 6 113072 58 34843795
Anaesthetic complication cardiac 14.34 10.97 5 113073 28 34843825
Laryngeal cancer metastatic 14.32 10.97 6 113072 59 34843794
Urinary ascites 14.26 10.97 4 113074 9 34843844
Meningococcal bacteraemia 14.26 10.97 4 113074 9 34843844
Substance dependence 14.26 10.97 11 113067 372 34843481
Ventricular tachycardia 14.25 10.97 140 112938 26439 34817414
Orthostatic hypotension 14.25 10.97 40 113038 25879 34817974
Hippocampal atrophy 14.21 10.97 3 113075 0 34843853
Mechanical ventilation 14.20 10.97 24 113054 1946 34841907
Lymphadenopathy 14.16 10.97 46 113032 28417 34815436
Infection 14.08 10.97 208 112870 90707 34753146
Cardiac failure chronic 14.08 10.97 4 113074 7875 34835978
Chronic kidney disease 14.06 10.97 77 113001 41133 34802720
Oesophageal mucosa erythema 14.05 10.97 5 113073 30 34843823
Diverticulum 14.03 10.97 3 113075 7156 34836697
Performance status decreased 14.01 10.97 37 113041 4100 34839753
Weight decreased 13.99 10.97 449 112629 175852 34668001
Neuroendocrine tumour of the lung metastatic 13.92 10.97 7 113071 108 34843745
Application site erythema 13.69 10.97 26 113052 2310 34841543
Therapy partial responder 13.67 10.97 7 113071 9609 34834244
Blindness 13.67 10.97 17 113061 14969 34828884
Capillary nail refill test abnormal 13.65 10.97 5 113073 33 34843820
Intentional overdose 13.62 10.97 84 112994 43590 34800263
Vasculitis 13.59 10.97 10 113068 11286 34832567
Gastrointestinal disorder 13.56 10.97 60 113018 33888 34809965
Catecholamine crisis 13.53 10.97 5 113073 34 34843819
Product communication issue 13.50 10.97 11 113067 403 34843450
Trichoglossia 13.50 10.97 10 113068 318 34843535
Myelodysplastic syndrome 13.49 10.97 26 113052 19182 34824671
Exposure during pregnancy 13.47 10.97 6 113072 8928 34834925
Hypophonesis 13.44 10.97 4 113074 12 34843841
Unwanted awareness during anaesthesia 13.40 10.97 5 113073 35 34843818
Pathogen resistance 13.33 10.97 7 113071 9475 34834378
Oedema 13.23 10.97 90 112988 45651 34798202
Angina unstable 13.15 10.97 11 113067 11642 34832211
Therapeutic product effect prolonged 13.14 10.97 9 113069 252 34843601
Pulmonary haemorrhage 13.12 10.97 67 113011 10237 34833616
Non-small cell lung cancer 13.10 10.97 35 113043 3905 34839948
PCO2 increased 13.02 10.97 13 113065 623 34843230
Mucosal atrophy 12.98 10.97 6 113072 76 34843777
Medical device site fistula 12.94 10.97 5 113073 39 34843814
Depressed mood 12.84 10.97 27 113051 19290 34824563
Atrial septal defect 12.76 10.97 4 113074 7388 34836465
Salivary hypersecretion 12.73 10.97 6 113072 8638 34835215
Locked-in syndrome 12.72 10.97 9 113069 266 34843587
Rash erythematous 12.68 10.97 40 113038 24937 34818916
Secretion discharge 12.67 10.97 45 113033 5860 34837993
Electroencephalogram abnormal 12.61 10.97 26 113052 2452 34841401
Gastritis 12.59 10.97 33 113045 21840 34822013
Toxicologic test abnormal 12.57 10.97 12 113066 544 34843309
Trismus 12.49 10.97 26 113052 2469 34841384
Thrombocytopenia 12.38 10.97 398 112680 155849 34688004
Bladder cancer 12.36 10.97 21 113057 16257 34827596
Abdominal pain upper 12.34 10.97 160 112918 71330 34772523
Tracheal pain 12.32 10.97 5 113073 45 34843808
Micturition urgency 12.26 10.97 3 113075 6522 34837331
Areflexia 12.26 10.97 29 113049 3002 34840851
Atonic urinary bladder 12.19 10.97 4 113074 18 34843835
Aspergillus infection 12.15 10.97 13 113065 12241 34831612
Glossopharyngeal nerve paralysis 12.14 10.97 3 113075 3 34843850
Pancreatic carcinoma 12.12 10.97 59 113019 8842 34835011
Diaphragmatic rupture 12.01 10.97 4 113074 19 34843834
Bronchopulmonary aspergillosis 11.99 10.97 18 113060 14641 34829212
Clinical trial participant 11.90 10.97 6 113072 93 34843760
Swollen tongue 11.88 10.97 18 113060 14587 34829266
Product administration error 11.84 10.97 92 112986 16252 34827601
End stage renal disease 11.80 10.97 7 113071 8854 34834999
Dyspepsia 11.79 10.97 70 113008 36662 34807191
Local anaesthetic systemic toxicity 11.75 10.97 9 113069 301 34843552
Pupil fixed 11.75 10.97 21 113057 1780 34842073
Swelling face 11.73 10.97 37 113041 23068 34820785
Epstein-Barr virus infection 11.70 10.97 5 113073 7623 34836230
Pathological fracture 11.69 10.97 36 113042 4355 34839498
Mean arterial pressure decreased 11.67 10.97 7 113071 155 34843698
Tumour pain 11.65 10.97 16 113062 1081 34842772
Pseudopolyp 11.59 10.97 8 113070 227 34843626
Mechanical ventilation complication 11.53 10.97 4 113074 22 34843831
Complication of device removal 11.52 10.97 5 113073 54 34843799
Drug eruption 11.47 10.97 30 113048 19868 34823985
Uveitis 11.46 10.97 5 113073 7530 34836323
No adverse event 11.44 10.97 37 113041 22890 34820963
Application site vesicles 11.44 10.97 12 113066 610 34843243
Ventricular fibrillation 11.39 10.97 119 112959 22835 34821018
Thirst decreased 11.38 10.97 4 113074 23 34843830
Airway peak pressure increased 11.38 10.97 4 113074 23 34843830
Haematochezia 11.36 10.97 96 112982 46438 34797415
Iron deficiency anaemia 11.35 10.97 10 113068 10319 34833534
Schizophrenia 11.32 10.97 7 113071 8659 34835194
Cellulitis 11.30 10.97 113 112965 52838 34791015
Malignant catatonia 11.26 10.97 8 113070 238 34843615
Laryngomalacia 11.21 10.97 9 113069 323 34843530
Phaeochromocytoma crisis 11.20 10.97 5 113073 58 34843795
Eastern Cooperative Oncology Group performance status worsened 11.15 10.97 15 113063 993 34842860
Immune thrombocytopenia 11.14 10.97 8 113070 9144 34834709
Arthropathy 11.08 10.97 47 113031 26860 34816993
SARS-CoV-2 test negative 11.01 10.97 15 113063 1005 34842848
Mobility decreased 11.00 10.97 55 113023 30073 34813780
Renal cyst 11 10.97 8 113070 9085 34834768
Procedural hypertension 10.98 10.97 5 113073 61 34843792
Oxidative stress 10.98 10.97 5 113073 61 34843792

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 13324.16 10.12 7139 207754 155552 79373943
Toxicity to various agents 3058.70 10.12 4643 210250 416897 79112598
Respiratory arrest 1615.75 10.12 1297 213596 56253 79473242
Cardiac arrest 1452.99 10.12 2041 212852 170055 79359440
Cardio-respiratory arrest 1343.01 10.12 1557 213336 106953 79422542
Serotonin syndrome 1090.99 10.12 932 213961 44095 79485400
Respiratory depression 1044.06 10.12 744 214149 26886 79502609
Incorrect route of product administration 907.95 10.12 753 214140 34176 79495319
Overdose 896.22 10.12 1703 213190 182503 79346992
Drug withdrawal syndrome 698.42 10.12 647 214246 34071 79495424
Death 655.74 10.12 3138 211755 563376 78966119
Prescription drug used without a prescription 595.52 10.12 267 214626 3818 79525677
Intentional product misuse 541.16 10.12 942 213951 94223 79435272
Anaphylactic reaction 527.94 10.12 868 214025 82875 79446620
Unresponsive to stimuli 500.29 10.12 682 214211 55106 79474389
Miosis 447.29 10.12 358 214535 15431 79514064
Product adhesion issue 443.48 10.12 192 214701 2512 79526983
Drug dependence 406.45 10.12 525 214368 40244 79489251
Inadequate analgesia 401.15 10.12 212 214681 4417 79525078
Depressed level of consciousness 379.33 10.12 818 214075 95834 79433661
Accidental exposure to product by child 359.99 10.12 170 214723 2756 79526739
Drug interaction 358.08 10.12 2123 212770 413060 79116435
Synovitis 355.86 10.12 11 214882 150723 79378772
Hyperthermia malignant 348.24 10.12 166 214727 2751 79526744
Apnoea 345.71 10.12 272 214621 11432 79518063
Hypotension 334.29 10.12 2179 212714 438138 79091357
Somnolence 304.86 10.12 1364 213529 237617 79291878
Arthralgia 299.83 10.12 688 214205 571115 78958380
Hyperaesthesia 295.87 10.12 253 214640 11969 79517526
Delayed recovery from anaesthesia 288.21 10.12 123 214770 1550 79527945
Joint swelling 287.11 10.12 215 214678 288431 79241064
Anaesthetic complication 282.46 10.12 143 214750 2716 79526779
Delirium 278.42 10.12 668 214225 83959 79445536
Accidental overdose 266.67 10.12 423 214470 39158 79490337
Systemic lupus erythematosus 265.49 10.12 15 214878 121134 79408361
Alopecia 263.14 10.12 148 214745 231207 79298288
Hand deformity 259.22 10.12 4 214889 103915 79425580
Pulmonary oedema 258.07 10.12 666 214227 87588 79441907
Bradycardia 253.48 10.12 873 214020 134684 79394811
Nasopharyngitis 252.59 10.12 189 214704 253692 79275803
Infusion related reaction 246.82 10.12 158 214735 230079 79299416
Maternal exposure during delivery 245.32 10.12 103 214790 1243 79528252
Headache 240.51 10.12 928 213965 652844 78876651
Arthropathy 227.65 10.12 96 214797 177015 79352480
Rash 225.04 10.12 802 214091 577556 78951939
Glossodynia 222.77 10.12 14 214879 103323 79426172
Sinusitis 219.52 10.12 127 214766 195374 79334121
Bradypnoea 214.89 10.12 157 214736 5895 79523600
Respiratory acidosis 208.47 10.12 200 214693 11000 79518495
Myoclonus 207.93 10.12 311 214582 27349 79502146
Rheumatoid arthritis 207.57 10.12 155 214738 208315 79321180
Neuromuscular block prolonged 201.82 10.12 83 214810 947 79528548
Fatigue 200.40 10.12 1577 213316 928150 78601345
Withdrawal syndrome 197.68 10.12 299 214594 26555 79502940
Product prescribing error 197.61 10.12 398 214495 44415 79485080
Cough 196.28 10.12 436 214457 366353 79163142
Pericarditis 195.57 10.12 25 214868 104211 79425284
Abdominal discomfort 195.05 10.12 233 214660 250494 79279001
Product quality issue 186.33 10.12 331 214562 33609 79495886
Peripheral swelling 185.83 10.12 274 214619 269343 79260152
Drug intolerance 184.40 10.12 266 214627 263853 79265642
Drug use disorder 177.35 10.12 163 214730 8488 79521007
Malignant neoplasm progression 176.07 10.12 780 214113 135210 79394285
Weight increased 174.99 10.12 299 214594 277087 79252408
Product complaint 172.32 10.12 196 214697 13153 79516342
Contraindicated product administered 170.30 10.12 107 214786 157431 79372064
Helicobacter infection 168.52 10.12 4 214889 69700 79459795
Swelling 166.82 10.12 203 214690 216508 79312987
Hypoxia 165.06 10.12 632 214261 102611 79426884
Pruritus 163.65 10.12 532 214361 394116 79135379
Amnestic disorder 163.35 10.12 62 214831 562 79528933
Brain oedema 161.97 10.12 264 214629 24999 79504496
Treatment failure 158.11 10.12 136 214757 170350 79359145
Respiratory rate decreased 155.17 10.12 122 214771 5121 79524374
Coma 155.09 10.12 609 214284 100040 79429455
Procedural hypotension 151.20 10.12 84 214809 1939 79527556
Fear 150.88 10.12 237 214656 21749 79507746
Off label use 150.30 10.12 1643 213250 905572 78623923
Hepatic enzyme increased 149.24 10.12 163 214730 182447 79347048
Duodenal ulcer perforation 148.82 10.12 7 214886 66204 79463291
Product dose omission issue 148.74 10.12 275 214618 247262 79282233
Anaphylactic shock 148.45 10.12 311 214582 35685 79493810
Pulseless electrical activity 146.84 10.12 186 214707 13974 79515521
Agitation 142.19 10.12 589 214304 99126 79430369
Tachycardia 138.25 10.12 886 214007 176882 79352613
Completed suicide 136.53 10.12 1130 213763 244637 79284858
Bronchospasm 134.60 10.12 241 214652 24618 79504877
Post procedural complication 134.16 10.12 235 214658 23594 79505901
Lower respiratory tract infection 133.92 10.12 92 214801 129128 79400367
Stress cardiomyopathy 132.50 10.12 157 214736 11009 79518486
Injection site pain 127.31 10.12 98 214795 129740 79399755
Respiratory failure 127.01 10.12 879 214014 180032 79349463
Opiates positive 125.57 10.12 59 214834 945 79528550
Folliculitis 124.00 10.12 6 214887 55374 79474121
Drug abuser 120.75 10.12 112 214781 5901 79523594
Renal injury 119.68 10.12 185 214708 16742 79512753
Muscle injury 116.57 10.12 3 214890 48558 79480937
Muscle rigidity 115.75 10.12 199 214694 19683 79509812
Diarrhoea 113.49 10.12 1681 213212 878808 78650687
Oxygen saturation decreased 113.46 10.12 664 214229 128383 79401112
Irritable bowel syndrome 109.60 10.12 18 214875 62223 79467272
Blood pressure decreased 107.86 10.12 542 214351 98924 79430571
Anhedonia 106.98 10.12 164 214729 14734 79514761
Poisoning 106.13 10.12 220 214673 25052 79504443
Hypoventilation 105.22 10.12 113 214780 7111 79522384
Hypersensitivity 104.83 10.12 359 214534 261880 79267615
Circulatory collapse 104.67 10.12 279 214614 37389 79492106
Myoglobin urine present 104.30 10.12 51 214842 896 79528599
Asthma 103.44 10.12 127 214766 134968 79394527
Blood cholesterol increased 103.40 10.12 48 214845 83672 79445823
COVID-19 103.04 10.12 166 214727 157508 79371987
Propofol infusion syndrome 102.75 10.12 65 214828 1918 79527577
Wound 102.53 10.12 97 214796 116082 79413413
Kounis syndrome 102.33 10.12 88 214805 4194 79525301
Drug diversion 101.98 10.12 55 214838 1195 79528300
Presbyacusis 101.28 10.12 72 214821 2588 79526907
Procedural complication 100.99 10.12 116 214777 7867 79521628
Deafness neurosensory 100.64 10.12 108 214785 6790 79522705
Haemodynamic instability 98.61 10.12 172 214721 17210 79512285
Neoplasm progression 97.52 10.12 334 214559 51348 79478147
Hypercapnia 96.84 10.12 120 214773 8815 79520680
Emotional distress 96.24 10.12 281 214612 39688 79489807
Musculoskeletal stiffness 94.32 10.12 207 214686 174801 79354694
Product counterfeit 92.44 10.12 33 214860 247 79529248
Pain in extremity 90.89 10.12 592 214301 363946 79165549
Laryngospasm 89.20 10.12 79 214814 3918 79525577
Brain injury 87.27 10.12 130 214763 11387 79518108
Myalgia 87.12 10.12 236 214657 185405 79344090
Discomfort 86.13 10.12 128 214765 125489 79404006
Plasma cell myeloma 85.05 10.12 326 214567 52933 79476562
Confusional state 84.61 10.12 1264 213629 316733 79212762
Toxic leukoencephalopathy 83.75 10.12 47 214846 1107 79528388
Therapeutic product effect incomplete 83.58 10.12 159 214734 141486 79388009
Urinary retention 83.46 10.12 338 214555 56292 79473203
Influenza 83.22 10.12 138 214755 129468 79400027
C-reactive protein abnormal 82.94 10.12 15 214878 48352 79481143
Condition aggravated 82.07 10.12 909 213984 500215 79029280
Type 2 diabetes mellitus 81.73 10.12 26 214867 57096 79472399
Ill-defined disorder 80.99 10.12 38 214855 65837 79463658
Pleural fibrosis 80.57 10.12 76 214817 4091 79525404
Dizziness 80.36 10.12 970 213923 525471 79004024
Psoriatic arthropathy 80.18 10.12 56 214837 77943 79451552
Drug screen positive 79.92 10.12 90 214803 5973 79523522
Cyanosis 79.79 10.12 196 214697 24986 79504509
Knee arthroplasty 79.61 10.12 11 214882 43237 79486258
Medication error 77.93 10.12 379 214514 68263 79461232
Narcotic bowel syndrome 77.58 10.12 29 214864 251 79529244
Therapy naive 77.28 10.12 21 214872 52 79529443
Constipation 77.20 10.12 1130 213763 281920 79247575
Red blood cell sedimentation rate increased 75.09 10.12 16 214877 45926 79483569
Fibromyalgia 74.76 10.12 40 214853 64300 79465195
Faecaloma 74.33 10.12 121 214772 11443 79518052
Ventricular tachycardia 73.07 10.12 264 214629 41671 79487824
Counterfeit product administered 72.74 10.12 23 214870 112 79529383
Labile blood pressure 72.28 10.12 55 214838 2198 79527297
Mental status changes 71.96 10.12 364 214529 66595 79462900
Wrong technique in product usage process 70.75 10.12 389 214504 73486 79456009
Loss of consciousness 69.86 10.12 726 214167 167217 79362278
Blood magnesium increased 69.81 10.12 65 214828 3441 79526054
Anaesthetic complication neurological 68.89 10.12 34 214859 610 79528885
Metabolic acidosis 68.89 10.12 419 214474 82110 79447385
Sedation 68.88 10.12 300 214593 51595 79477900
Pleural thickening 68.67 10.12 60 214833 2922 79526573
Amphetamines positive 68.51 10.12 28 214865 314 79529181
Hip arthroplasty 68.46 10.12 8 214885 35748 79493747
Disorientation 67.98 10.12 342 214551 62434 79467061
Hypoxic-ischaemic encephalopathy 67.64 10.12 94 214799 7726 79521769
Dyspnoea exertional 66.49 10.12 82 214811 86991 79442504
Airway complication of anaesthesia 66.20 10.12 29 214864 391 79529104
Intensive care unit acquired weakness 66.04 10.12 49 214844 1884 79527611
Clonus 64.90 10.12 86 214807 6754 79522741
Injection site erythema 64.74 10.12 69 214824 78128 79451367
Multiple organ dysfunction syndrome 64.61 10.12 549 214344 119697 79409798
Mobility decreased 64.59 10.12 146 214747 122029 79407466
Cardiac failure congestive 64.59 10.12 184 214709 142218 79387277
Malaise 64.34 10.12 931 213962 488938 79040557
Impaired driving ability 64.02 10.12 76 214817 5339 79524156
Anterior spinal artery syndrome 63.49 10.12 21 214872 121 79529374
Drug ineffective 63.44 10.12 2330 212563 1078583 78450912
Premature delivery 63.37 10.12 172 214721 23295 79506200
Blood potassium increased 63.13 10.12 198 214695 29077 79500418
Intestinal pseudo-obstruction 63.13 10.12 54 214839 2555 79526940
Bronchitis 62.86 10.12 164 214729 130480 79399015
Intercepted product dispensing error 60.91 10.12 21 214872 140 79529355
Herpes zoster 60.79 10.12 98 214795 92985 79436510
Tachypnoea 60.29 10.12 207 214686 31856 79497639
Nasal congestion 59.60 10.12 71 214822 76481 79453014
Basal cell carcinoma 59.11 10.12 14 214879 37361 79492134
Allodynia 59.07 10.12 43 214850 1605 79527890
Metastases to bone 59.06 10.12 172 214721 24255 79505240
Blister 58.23 10.12 149 214744 119327 79410168
Loss of personal independence in daily activities 58.04 10.12 118 214775 102462 79427033
Coma scale abnormal 57.41 10.12 92 214801 8586 79520909
Product use issue 57.32 10.12 331 214562 209491 79320004
Device expulsion 57.26 10.12 3 214890 25858 79503637
Dyspnoea 57.03 10.12 1818 213075 855207 78674288
Abdominal pain upper 56.99 10.12 361 214532 223458 79306037
Tryptase increased 56.84 10.12 30 214863 623 79528872
Recurrence of neuromuscular blockade 56.76 10.12 24 214869 295 79529200
Palpitations 56.39 10.12 165 214728 126445 79403050
Infusion site coldness 56.33 10.12 22 214871 217 79529278
Arthritis 56.19 10.12 143 214750 114737 79414758
Pulse absent 56.04 10.12 99 214794 10004 79519491
Infection 55.98 10.12 401 214492 241311 79288184
Stomatitis 55.86 10.12 205 214688 146552 79382943
Chest discomfort 55.78 10.12 188 214705 137856 79391639
Accidental death 55.37 10.12 63 214830 4228 79525267
Systemic infection 54.67 10.12 96 214797 9656 79519839
Diabetes insipidus 54.63 10.12 69 214824 5168 79524327
Spinal muscular atrophy 54.50 10.12 25 214868 378 79529117
Application site pruritus 54.44 10.12 59 214834 3751 79525744
Therapeutic product effect prolonged 54.41 10.12 28 214865 551 79528944
Oropharyngeal pain 54.36 10.12 135 214758 109218 79420277
Therapeutic product effect increased 54.07 10.12 40 214853 1531 79527964
Cachexia 53.16 10.12 102 214791 10981 79518514
Endotracheal intubation complication 53.02 10.12 31 214862 791 79528704
Unevaluable event 52.75 10.12 292 214601 55293 79474202
Accidental exposure to product 52.72 10.12 195 214698 31127 79498368
Transient ischaemic attack 52.63 10.12 39 214854 52656 79476839
Brain death 51.76 10.12 70 214823 5607 79523888
Injection site reaction 51.62 10.12 43 214850 54742 79474753
Neuromuscular blockade 51.49 10.12 27 214866 553 79528942
Contusion 51.41 10.12 216 214677 148560 79380935
Application site erythema 51.21 10.12 66 214827 5044 79524451
Pulmonary congestion 50.99 10.12 175 214718 26925 79502570
Abortion spontaneous 50.92 10.12 9 214884 29498 79499997
Gastrooesophageal reflux disease 50.80 10.12 130 214763 104116 79425379
Wheezing 50.54 10.12 154 214739 116510 79412985
Ear infection 50.47 10.12 15 214878 34417 79495078
Breakthrough pain 49.94 10.12 36 214857 1323 79528172
Upper respiratory tract infection 49.79 10.12 107 214786 91061 79438434
Acute respiratory distress syndrome 49.07 10.12 242 214651 43825 79485670
Psoriasis 48.21 10.12 106 214787 89481 79440014
Injection site pruritus 48.08 10.12 27 214866 42256 79487239
Restlessness 48.04 10.12 250 214643 46242 79483253
Encephalopathy 47.55 10.12 328 214565 67069 79462426
Renal failure 47.37 10.12 783 214110 200185 79329310
Gastrointestinal disorder 46.97 10.12 170 214723 122035 79407460
Substance use 46.86 10.12 30 214863 904 79528591
Application site reaction 46.74 10.12 28 214865 748 79528747
Increased bronchial secretion 46.63 10.12 51 214842 3276 79526219
Anion gap 46.48 10.12 42 214851 2139 79527356
Gamma-glutamyltransferase decreased 46.29 10.12 22 214871 362 79529133
Acute lung injury 46.04 10.12 49 214844 3051 79526444
Local anaesthetic systemic toxicity 45.94 10.12 31 214862 1023 79528472
Normal newborn 45.45 10.12 74 214819 6998 79522497
Cerebrovascular accident 45.12 10.12 240 214653 155052 79374443
General physical health deterioration 44.96 10.12 1014 213879 274224 79255271
Hypermobility syndrome 44.64 10.12 24 214869 518 79528977
Epigastric discomfort 44.61 10.12 78 214815 7818 79521677
Injection site swelling 44.40 10.12 37 214856 47095 79482400
Upper airway obstruction 43.93 10.12 34 214859 1394 79528101
Diabetes mellitus 43.64 10.12 91 214802 78299 79451196
Lethargy 43.58 10.12 371 214522 80921 79448574
Osteoporosis 43.40 10.12 49 214844 54063 79475432
Application site rash 43.37 10.12 40 214853 2092 79527403
Hyperhidrosis 42.91 10.12 609 214284 150883 79378612
Sinus tachycardia 42.76 10.12 205 214688 36703 79492792
Negative pressure pulmonary oedema 42.66 10.12 18 214875 220 79529275
Myelosuppression 42.65 10.12 28 214865 40268 79489227
Electrocardiogram ST segment elevation 42.41 10.12 79 214814 8318 79521177
Ventricular fibrillation 41.93 10.12 184 214709 31742 79497753
Anterograde amnesia 41.79 10.12 25 214868 666 79528829
Resuscitation 41.13 10.12 41 214852 2363 79527132
Insomnia 41.13 10.12 442 214451 244728 79284767
Methaemoglobinaemia 41.07 10.12 62 214831 5495 79524000
Inflammation 40.43 10.12 124 214769 93629 79435866
Anaesthetic complication pulmonary 40.19 10.12 13 214880 69 79529426
Carcinoid crisis 39.86 10.12 22 214871 501 79528994
Cytomegalovirus infection 39.53 10.12 34 214859 42610 79486885
Airway peak pressure increased 39.21 10.12 19 214874 327 79529168
Cataract 39.07 10.12 67 214826 62053 79467442
Arteriospasm coronary 38.80 10.12 67 214826 6649 79522846
Gait disturbance 38.57 10.12 365 214528 207141 79322354
Joint stiffness 38.52 10.12 32 214861 40798 79488697
Diabetic ketoacidosis 38.50 10.12 22 214871 34100 79495395
Blood glucose increased 38.44 10.12 169 214724 114806 79414689
Toxic encephalopathy 38.34 10.12 91 214802 11349 79518146
Drug tolerance 38.17 10.12 77 214816 8598 79520897
Compartment syndrome 37.98 10.12 57 214836 5025 79524470
Bradycardia foetal 37.57 10.12 14 214879 120 79529375
Eczema 37.28 10.12 33 214860 40785 79488710
Unwanted awareness during anaesthesia 37.24 10.12 18 214875 308 79529187
Injury 37.07 10.12 345 214548 77151 79452344
Procedural hypertension 36.87 10.12 18 214875 315 79529180
Leukoencephalopathy 36.84 10.12 72 214821 7857 79521638
Joint range of motion decreased 36.78 10.12 22 214871 33260 79496235
Rash pruritic 36.72 10.12 87 214806 71542 79457953
Osteopenia 36.68 10.12 121 214772 18243 79511252
Blood pressure increased 36.68 10.12 378 214515 210982 79318513
Vasodilatation 36.43 10.12 44 214849 3147 79526348
Altered state of consciousness 36.25 10.12 222 214671 43600 79485895
Vomiting 36.23 10.12 2165 212728 663663 78865832
Progressive multifocal leukoencephalopathy 36.17 10.12 6 214887 20594 79508901
Therapeutic product effect decreased 35.93 10.12 276 214617 163587 79365908
Horner's syndrome 35.92 10.12 10 214883 28 79529467
Application site dermatitis 35.87 10.12 15 214878 179 79529316
Myocardial ischaemia 35.77 10.12 150 214743 25369 79504126
Drug-induced liver injury 35.76 10.12 78 214815 66039 79463456
Ventilation perfusion mismatch 35.74 10.12 22 214871 618 79528877
Pneumonia aspiration 35.56 10.12 305 214588 66662 79462833
Exposure to toxic agent 35.30 10.12 77 214816 9081 79520414
Hyperthermia 35.28 10.12 118 214775 17919 79511576
Drug resistance 35.21 10.12 37 214856 42176 79487319
Productive cough 35.19 10.12 121 214772 88210 79441285
Post procedural hypotension 35.19 10.12 12 214881 77 79529418
Stoma closure 35.11 10.12 17 214876 292 79529203
Fluid retention 34.83 10.12 86 214807 69723 79459772
Trigemino-cardiac reflex 34.24 10.12 16 214877 253 79529242
Generalised tonic-clonic seizure 34.17 10.12 219 214674 43691 79485804
Orthostatic hypotension 34.04 10.12 62 214831 56102 79473393
Rhinorrhoea 33.97 10.12 99 214794 75975 79453520
Cancer pain 33.87 10.12 55 214838 5190 79524305
Oxygen saturation immeasurable 33.82 10.12 10 214883 37 79529458
Oedema peripheral 33.57 10.12 478 214415 251810 79277685
Pneumococcal sepsis 33.46 10.12 31 214862 1631 79527864
Osteosclerosis 33.26 10.12 47 214846 3924 79525571
Postmortem blood drug level 33.20 10.12 17 214876 331 79529164
Hepatic ischaemia 33.11 10.12 26 214867 1089 79528406
Nephrolithiasis 33.04 10.12 58 214835 53233 79476262
Paraplegia 32.65 10.12 53 214840 5000 79524495
Femoral hernia incarcerated 32.54 10.12 23 214870 819 79528676
Postoperative delirium 32.52 10.12 17 214876 346 79529149
Troponin increased 32.51 10.12 120 214773 19135 79510360
Acidosis 32.40 10.12 122 214771 19640 79509855
Substance abuse 32.36 10.12 81 214812 10445 79519050
Neurotoxicity 32.32 10.12 173 214720 32345 79497150
Apnoeic attack 32.22 10.12 21 214872 653 79528842
Pregnancy 32.22 10.12 16 214877 26835 79502660
Systolic anterior motion of mitral valve 31.57 10.12 10 214883 49 79529446
Swelling face 31.56 10.12 93 214800 71119 79458376
Multiple sclerosis relapse 31.32 10.12 48 214845 46485 79483010
Spinal cord infarction 31.23 10.12 20 214873 603 79528892
Lymphatic fistula 31.19 10.12 22 214871 781 79528714
Non-small cell lung cancer 31.08 10.12 59 214834 6301 79523194
Liver disorder 31.07 10.12 96 214797 72321 79457174
Pupil fixed 31.05 10.12 43 214850 3523 79525972
Postmortem blood drug level increased 31.04 10.12 22 214871 787 79528708
Blood pressure diastolic abnormal 30.75 10.12 7 214886 19195 79510300
Hallucination 30.73 10.12 360 214533 85385 79444110
Sinus arrest 30.53 10.12 43 214850 3579 79525916
Neuropathy peripheral 30.51 10.12 239 214654 141066 79388429
Left ventricle outflow tract obstruction 30.46 10.12 17 214876 396 79529099
Visual impairment 30.45 10.12 136 214757 91995 79437500
C-reactive protein increased 30.36 10.12 213 214680 128814 79400681
Coagulopathy 30.16 10.12 183 214710 35823 79493672
Amylase increased 30.10 10.12 82 214811 11127 79518368
Hypogonadism 30.08 10.12 30 214863 1730 79527765
Dry skin 29.98 10.12 89 214804 67906 79461589
Cauda equina syndrome 29.86 10.12 27 214866 1376 79528119
Injection site bruising 29.86 10.12 40 214853 40962 79488533
Arachnoid web 29.60 10.12 7 214886 7 79529488
Self-medication 29.39 10.12 51 214842 5081 79524414
Motor neurone disease 29.20 10.12 19 214874 589 79528906
Product use in unapproved indication 29.01 10.12 487 214406 249872 79279623
Blood pressure measurement 29.00 10.12 17 214876 436 79529059
Poor quality product administered 28.85 10.12 42 214851 3603 79525892
Rhythm idioventricular 28.75 10.12 19 214874 605 79528890
Dyskinesia 28.74 10.12 213 214680 44560 79484935
Conversion disorder 28.68 10.12 30 214863 1831 79527664
Anaesthetic complication cardiac 28.59 10.12 10 214883 70 79529425
Renal impairment 28.53 10.12 590 214303 157193 79372302
Application site irritation 28.48 10.12 29 214864 1715 79527780
Eosinophilia 28.43 10.12 49 214844 45296 79484199
Tumour pain 28.40 10.12 33 214860 2266 79527229
Supraventricular tachycardia 28.25 10.12 123 214770 21147 79508348
Torsade de pointes 28.23 10.12 115 214778 19197 79510298
Lip dry 28.19 10.12 4 214889 15414 79514081
Eye pain 28.04 10.12 36 214857 37542 79491953
Hypopnoea 28.00 10.12 51 214842 5278 79524217
Sleep disorder due to a general medical condition 27.82 10.12 3 214890 14274 79515221
Bone cyst 27.82 10.12 40 214853 3393 79526102
Phrenic nerve paralysis 27.81 10.12 15 214878 326 79529169
Acute postoperative sialadenitis 27.79 10.12 9 214884 48 79529447
Anorectal ulcer 27.48 10.12 9 214884 50 79529445
Non-consummation 27.48 10.12 9 214884 50 79529445
Skin exfoliation 27.39 10.12 68 214825 55032 79474463
Paralysis 27.38 10.12 88 214805 13089 79516406
Application site vesicles 27.34 10.12 26 214867 1414 79528081
Prostate cancer metastatic 27.22 10.12 43 214850 3964 79525531
Angina pectoris 27.18 10.12 62 214831 51670 79477825
Paraesthesia 27.15 10.12 324 214569 175999 79353496
Muscle relaxant therapy 27.12 10.12 12 214881 166 79529329
Localised infection 27.02 10.12 37 214856 37538 79491957
Dependence 27.01 10.12 33 214860 2389 79527106
Full blood count abnormal 27.00 10.12 42 214851 40432 79489063
Musculoskeletal disorder 26.94 10.12 12 214881 21436 79508059
Opisthotonus 26.87 10.12 19 214874 677 79528818
Impaired healing 26.84 10.12 133 214760 87522 79441973
Throat irritation 26.83 10.12 43 214850 40903 79488592
Seroma 26.73 10.12 32 214861 2268 79527227
Mental status changes postoperative 26.67 10.12 12 214881 173 79529322
Performance status decreased 26.59 10.12 54 214839 6059 79523436
Atrioventricular block second degree 26.52 10.12 60 214833 7252 79522243
Liver injury 26.51 10.12 72 214821 56542 79472953
Autonomic nervous system imbalance 26.50 10.12 46 214847 4584 79524911
Non-cardiogenic pulmonary oedema 26.45 10.12 26 214867 1473 79528022
Exposure during pregnancy 26.44 10.12 401 214492 100731 79428764
Adverse event 26.42 10.12 79 214814 60135 79469360
Grip strength decreased 26.29 10.12 13 214880 21856 79507639
Pancreatic steatosis 26.29 10.12 23 214870 1122 79528373
Hyperreflexia 26.28 10.12 65 214828 8320 79521175
Thermophobia 26.23 10.12 9 214884 59 79529436
Mean arterial pressure decreased 26.22 10.12 15 214878 367 79529128
Product administered at inappropriate site 26.18 10.12 42 214851 3923 79525572
Urticaria 26.02 10.12 347 214546 184854 79344641
Stridor 25.93 10.12 50 214843 5403 79524092
Oculocardiac reflex 25.85 10.12 9 214884 62 79529433
Rhabdomyolysis 25.84 10.12 406 214487 102725 79426770
Spinal cord injury 25.77 10.12 24 214869 1271 79528224
Postoperative ileus 25.68 10.12 22 214871 1043 79528452
Pulmonary fibrosis 25.58 10.12 50 214843 44062 79485433
Cystitis 25.50 10.12 66 214827 52666 79476829
Tuberculosis 25.44 10.12 5 214888 15193 79514302
Muscle spasms 25.42 10.12 325 214568 174405 79355090
Blood pressure systolic increased 25.19 10.12 94 214799 66892 79462603
Myocardial infarction 25.14 10.12 347 214546 183782 79345713
Acute motor axonal neuropathy 25.05 10.12 10 214883 105 79529390
Spinal cord compression 25.02 10.12 54 214839 6323 79523172
Anticholinergic syndrome 24.88 10.12 39 214854 3572 79525923
Hypercapnic coma 24.76 10.12 15 214878 409 79529086
Wound infection pseudomonas 24.75 10.12 26 214867 1595 79527900
Sneezing 24.74 10.12 11 214882 19672 79509823
Vasoplegia syndrome 24.72 10.12 39 214854 3591 79525904
Hepatic failure 24.66 10.12 263 214630 60949 79468546
Confusion postoperative 24.58 10.12 12 214881 210 79529285
Infusion site induration 24.47 10.12 22 214871 1113 79528382
Vascular resistance systemic decreased 24.43 10.12 12 214881 213 79529282
Blood pressure systolic abnormal 24.40 10.12 8 214885 17239 79512256
Vision blurred 24.34 10.12 176 214717 105722 79423773
Blood pressure fluctuation 24.11 10.12 96 214797 67049 79462446
Air embolism 24.03 10.12 15 214878 432 79529063
Depressed mood 23.97 10.12 60 214833 48420 79481075
Epistaxis 23.89 10.12 189 214704 111326 79418169
Tracheal deviation 23.76 10.12 11 214882 170 79529325
Fall 23.74 10.12 1073 213820 486556 79042939
Anaphylactoid reaction 23.71 10.12 48 214845 5374 79524121
Drug tolerance increased 23.70 10.12 17 214876 620 79528875
Coma blister 23.65 10.12 12 214881 229 79529266
Drug eruption 23.62 10.12 52 214841 43883 79485612
Blood ethanol 23.53 10.12 11 214882 174 79529321
Impaired quality of life 23.53 10.12 5 214888 14381 79515114
Dystonia 23.45 10.12 117 214776 21282 79508213
Joint injury 23.40 10.12 30 214863 31305 79498190
Dehydration 23.39 10.12 853 214040 247334 79282161
Wrong product administered 23.28 10.12 65 214828 8947 79520548
Vasculitis 23.28 10.12 20 214873 25082 79504413
Hypercholesterolaemia 23.18 10.12 17 214876 23078 79506417
Suicide attempt 23.07 10.12 130 214763 82802 79446693
Product packaging quantity issue 23.07 10.12 23 214870 1326 79528169
Ear pain 23 10.12 33 214860 32836 79496659
Limb discomfort 22.97 10.12 33 214860 32817 79496678
Toxicologic test abnormal 22.91 10.12 23 214870 1337 79528158
Tachyphylaxis 22.72 10.12 13 214880 318 79529177
Mydriasis 22.65 10.12 101 214792 17542 79511953
Injection site haemorrhage 22.61 10.12 25 214868 27845 79501650
Product contamination 22.51 10.12 22 214871 1238 79528257
Weight decreased 22.43 10.12 758 214135 354440 79175055
Asphyxia 22.33 10.12 76 214817 11644 79517851
Respiratory distress 22.28 10.12 248 214645 58091 79471404
Viral infection 22.24 10.12 52 214841 42964 79486531
Sinus congestion 22.20 10.12 13 214880 19883 79509612
Potentiating drug interaction 22.19 10.12 63 214830 8756 79520739
Gastric disorder 22.08 10.12 42 214851 37391 79492104
Spontaneous haemorrhage 22.02 10.12 18 214875 799 79528696
Adverse drug reaction 21.94 10.12 98 214795 66294 79463201
Photosensitivity reaction 21.93 10.12 15 214878 21112 79508383
Application site pain 21.93 10.12 43 214850 4704 79524791
Oedema 21.92 10.12 211 214682 119369 79410126
Hypercreatininaemia 21.89 10.12 20 214873 1033 79528462
Head titubation 21.85 10.12 19 214874 919 79528576
Spinal anaesthesia 21.84 10.12 8 214885 65 79529430
Post procedural haemorrhage 21.83 10.12 84 214809 13660 79515835
Intestinal ischaemia 21.82 10.12 82 214811 13188 79516307
Seizure like phenomena 21.74 10.12 26 214867 1841 79527654
Hypoaesthesia 21.72 10.12 346 214547 179006 79350489
Vasoconstriction 21.63 10.12 17 214876 713 79528782
Hepatorenal syndrome 21.49 10.12 40 214853 4209 79525286
Pathogen resistance 21.47 10.12 6 214887 14336 79515159
Upper-airway cough syndrome 21.46 10.12 3 214890 11690 79517805
Therapy interrupted 21.41 10.12 32 214861 31309 79498186
Quadriplegia 21.38 10.12 35 214858 3325 79526170
Foot deformity 21.34 10.12 20 214873 24054 79505441
Autoimmune disorder 21.33 10.12 9 214884 16603 79512892
Hepatic cytolysis 21.33 10.12 25 214868 27126 79502369
Product administration error 21.30 10.12 153 214740 31693 79497802
Pseudopolyp 21.21 10.12 14 214879 445 79529050
Eye swelling 21.19 10.12 24 214869 26444 79503051
Dyspepsia 21.12 10.12 189 214704 108498 79420997
Injection site rash 21.09 10.12 11 214882 17943 79511552
Postmortem blood drug level abnormal 21.06 10.12 16 214877 638 79528857
Endotracheal intubation 21.04 10.12 42 214851 4655 79524840
Post transplant lymphoproliferative disorder 20.90 10.12 3 214890 11461 79518034
Breast cancer female 20.89 10.12 3 214890 11458 79518037
Eye pruritus 20.83 10.12 15 214878 20555 79508940
Granulocytopenia 20.82 10.12 3 214890 11428 79518067
Eosinophil count increased 20.82 10.12 10 214883 17095 79512400
Haemoglobin decreased 20.81 10.12 448 214445 221671 79307824
Myotonia 20.69 10.12 11 214882 232 79529263
Exposure to extreme temperature 20.67 10.12 5 214888 6 79529489
Tongue disorder 20.64 10.12 6 214887 13969 79515526
Coeliac disease 20.62 10.12 3 214890 11348 79518147
Chest pain 20.60 10.12 591 214302 281713 79247782
Foetal heart rate decreased 20.55 10.12 6 214887 21 79529474
Nodule 20.51 10.12 19 214874 22975 79506520
Polyarthritis 20.46 10.12 4 214889 12198 79517297
Erythema 20.45 10.12 452 214441 222838 79306657
Nystagmus 20.45 10.12 66 214827 9838 79519657
Drug detoxification 20.36 10.12 13 214880 390 79529105
Radiculopathy 20.25 10.12 61 214832 8763 79520732
Acute respiratory failure 20.03 10.12 247 214646 59294 79470201
Substance dependence 20.02 10.12 14 214879 490 79529005
Ileus 19.95 10.12 130 214763 26081 79503414
Transplant rejection 19.91 10.12 14 214879 19423 79510072
Eye irritation 19.77 10.12 16 214877 20665 79508830
Therapeutic response shortened 19.73 10.12 9 214884 15854 79513641
Manufacturing production issue 19.68 10.12 4 214889 0 79529495
Arterial haemorrhage 19.53 10.12 29 214864 2532 79526963
Oxidative stress 19.36 10.12 6 214887 27 79529468
Obesity 19.36 10.12 41 214852 35084 79494411
Prescribed underdose 19.33 10.12 31 214862 29483 79500012
Pyrexia 19.27 10.12 1571 213322 677138 78852357
Disease recurrence 19.26 10.12 58 214835 44051 79485444
Yawning 19.25 10.12 21 214872 1345 79528150
Ventricular arrhythmia 19.25 10.12 60 214833 8780 79520715
Dyslipidaemia 19.12 10.12 4 214889 11629 79517866
Agranulocytosis 19.10 10.12 60 214833 44970 79484525
Enthesopathy 19.06 10.12 4 214889 11604 79517891
Ventricular extrasystoles 19.02 10.12 104 214789 19600 79509895
Heavy menstrual bleeding 18.96 10.12 7 214886 14004 79515491
Skin sensitisation 18.96 10.12 18 214875 977 79528518
Polyneuropathy in malignant disease 18.94 10.12 11 214882 277 79529218
Panniculitis 18.85 10.12 5 214888 12366 79517129
Cardiac output decreased 18.83 10.12 24 214869 1814 79527681
Electrocardiogram ST segment depression 18.79 10.12 41 214852 4837 79524658
Balance disorder 18.73 10.12 173 214720 98684 79430811
Middle insomnia 18.65 10.12 10 214883 16059 79513436
Therapeutic response decreased 18.48 10.12 105 214788 66748 79462747
Anal inflammation 18.46 10.12 21 214872 1409 79528086
Weight bearing difficulty 18.43 10.12 32 214861 3189 79526306
Ischaemic cerebral infarction 18.33 10.12 28 214865 2507 79526988
Exposure via ingestion 18.26 10.12 42 214851 5132 79524363
Pulmonary toxicity 18.26 10.12 6 214887 12908 79516587
Postpartum haemorrhage 18.22 10.12 22 214871 1573 79527922
Urinary tract infection 18.22 10.12 582 214311 273930 79255565
Pathological fracture 18.07 10.12 66 214827 10471 79519024
Skin haemorrhage 17.96 10.12 5 214888 11976 79517519
Postoperative respiratory distress 17.96 10.12 5 214888 14 79529481
Cardiac failure chronic 17.95 10.12 4 214889 11131 79518364
Endometriosis 17.89 10.12 34 214859 3634 79525861
Subcutaneous emphysema 17.71 10.12 23 214870 1771 79527724
Reversal of sedation 17.71 10.12 5 214888 15 79529480
Drug specific antibody 17.57 10.12 28 214865 2600 79526895
Bladder cancer 17.57 10.12 16 214877 19510 79509985
Accidental poisoning 17.55 10.12 22 214871 1635 79527860
Product storage error 17.55 10.12 11 214882 16215 79513280
Foot fracture 17.52 10.12 20 214873 21961 79507534
Synovial cyst 17.52 10.12 3 214890 10062 79519433
Dermatitis atopic 17.50 10.12 3 214890 10053 79519442
Respiratory alkalosis 17.48 10.12 37 214856 4274 79525221
Areflexia 17.45 10.12 43 214850 5491 79524004
Vaccination site reaction 17.44 10.12 8 214885 121 79529374
Disseminated intravascular coagulation 17.35 10.12 160 214733 35682 79493813
Female genital tract fistula 17.35 10.12 45 214848 5930 79523565
Sopor 17.34 10.12 150 214743 32860 79496635
Diabetes mellitus inadequate control 17.34 10.12 24 214869 24240 79505255
Agitation postoperative 17.25 10.12 7 214886 77 79529418
Rash maculo-papular 17.22 10.12 85 214808 55993 79473502
Status epilepticus 17.15 10.12 121 214772 24920 79504575
Sphincter of Oddi dysfunction 17.13 10.12 12 214881 421 79529074
Lymphadenectomy 17.13 10.12 19 214874 1240 79528255
Glycosylated haemoglobin increased 17.08 10.12 16 214877 19244 79510251
Acute myeloid leukaemia 17.06 10.12 36 214857 30849 79498646
Type I hypersensitivity 16.98 10.12 37 214856 4361 79525134
Intentional self-injury 16.91 10.12 39 214854 32380 79497115
Uterine hypertonus 16.90 10.12 10 214883 261 79529234
Aspergillus infection 16.89 10.12 16 214877 19145 79510350
Mastocytosis 16.88 10.12 13 214880 529 79528966
Cardiac massage 16.80 10.12 5 214888 19 79529476
Syncope 16.79 10.12 362 214531 179087 79350408
Taste disorder 16.74 10.12 11 214882 15812 79513683
Mechanical ventilation complication 16.68 10.12 6 214887 46 79529449
Limb injury 16.67 10.12 34 214859 29494 79500001
Hepatic cirrhosis 16.64 10.12 44 214849 34862 79494633
Lower limb fracture 16.55 10.12 23 214870 23192 79506303
Tendon rupture 16.51 10.12 6 214887 12120 79517375
Heart rate irregular 16.50 10.12 40 214853 32639 79496856
Swollen tongue 16.49 10.12 59 214834 42511 79486984
Acne 16.49 10.12 30 214863 27160 79502335
Bursitis 16.47 10.12 46 214847 35798 79493697
Coronary artery disease 16.44 10.12 106 214787 65368 79464127
Carpal tunnel syndrome 16.42 10.12 17 214876 19511 79509984
Illness 16.38 10.12 67 214826 46444 79483051
Pituitary apoplexy 16.35 10.12 9 214884 204 79529291
Device dislocation 16.34 10.12 28 214865 25942 79503553
Tooth loss 16.32 10.12 49 214844 7026 79522469
Atrioventricular block complete 16.25 10.12 88 214805 16522 79512973
Stupor 16.24 10.12 48 214845 6824 79522671
Pancreatic carcinoma metastatic 16.14 10.12 33 214860 3720 79525775
Haematotoxicity 16.13 10.12 11 214882 15508 79513987
Cyst 16.12 10.12 77 214816 13763 79515732
Rhinitis 16.07 10.12 10 214883 14797 79514698
Bezold-Jarisch reflex 16.04 10.12 5 214888 23 79529472
Aspiration 15.97 10.12 101 214792 20057 79509438
Chemical peritonitis 15.93 10.12 10 214883 291 79529204
Joint effusion 15.93 10.12 15 214878 17999 79511496
Tachyarrhythmia 15.86 10.12 48 214845 6914 79522581
Lower respiratory tract infection bacterial 15.80 10.12 16 214877 940 79528555
Pulmonary alveolar haemorrhage 15.79 10.12 67 214826 11390 79518105
Intensive care unit delirium 15.75 10.12 6 214887 55 79529440
Preternatural anus 15.74 10.12 7 214886 98 79529397
Pulmonary arterial hypertension 15.72 10.12 33 214860 28333 79501162
Lymphadenopathy 15.62 10.12 82 214811 53165 79476330
Hypermagnesaemia 15.61 10.12 18 214875 1226 79528269
Environmental exposure 15.58 10.12 11 214882 391 79529104
Piloerection 15.55 10.12 12 214881 490 79529005
Asthenia 15.50 10.12 1178 213715 510511 79018984
Gastroenteritis 15.47 10.12 44 214849 34038 79495457
Hyponatraemia 15.44 10.12 363 214530 177485 79352010
Central nervous system stimulation 15.38 10.12 6 214887 59 79529436
Prinzmetal angina 15.36 10.12 21 214872 1699 79527796
Food allergy 15.35 10.12 5 214888 10819 79518676
Locked-in syndrome 15.30 10.12 14 214879 725 79528770
Medical device site pain 15.28 10.12 10 214883 313 79529182
Colitis microscopic 15.23 10.12 5 214888 10763 79518732
Adjustment disorder with depressed mood 15.19 10.12 3 214890 9083 79520412
Cardiac failure 15.18 10.12 310 214583 154532 79374963
Metastases to spine 15.15 10.12 35 214858 4289 79525206
Spinal epidural haematoma 15.15 10.12 19 214874 1413 79528082
Neuroendocrine tumour of the lung metastatic 15.07 10.12 7 214886 109 79529386
Post-traumatic neck syndrome 14.96 10.12 23 214870 2071 79527424
Arthrofibrosis 14.96 10.12 7 214886 111 79529384
Uveitis 14.90 10.12 14 214879 16816 79512679
Phaeochromocytoma crisis 14.90 10.12 10 214883 327 79529168
Neutropenia 14.82 10.12 629 214264 287081 79242414
Hyperlipidaemia 14.77 10.12 30 214863 26063 79503432
Decorticate posture 14.76 10.12 10 214883 332 79529163
Peroneal nerve palsy postoperative 14.76 10.12 3 214890 0 79529495
Cerebral artery perforation 14.76 10.12 3 214890 0 79529495
Drug effect faster than expected 14.76 10.12 3 214890 0 79529495
Pulse pressure abnormal 14.76 10.12 3 214890 0 79529495
Suicidal ideation 14.72 10.12 133 214760 76207 79453288
Atrioventricular dissociation 14.66 10.12 10 214883 336 79529159
Laryngitis 14.61 10.12 13 214880 16026 79513469
Renal cyst 14.58 10.12 11 214882 14721 79514774
Squamous cell carcinoma of skin 14.52 10.12 10 214883 14023 79515472
Posturing 14.51 10.12 16 214877 1037 79528458
Long QT syndrome 14.46 10.12 42 214851 5913 79523582
Extradural haematoma 14.45 10.12 27 214866 2849 79526646
Creatinine renal clearance decreased 14.39 10.12 18 214875 18984 79510511
Sinus disorder 14.33 10.12 24 214869 22440 79507055
Gastrointestinal scarring 14.30 10.12 10 214883 350 79529145
Product administered to patient of inappropriate age 14.30 10.12 40 214853 5513 79523982
Blood pressure diastolic increased 14.21 10.12 11 214882 14531 79514964
Fungal infection 14.17 10.12 61 214832 41687 79487808
Visual acuity reduced 14.16 10.12 37 214856 29432 79500063
Disease complication 14.15 10.12 37 214856 4900 79524595
Blood glucose decreased 14.14 10.12 31 214862 26203 79503292
Device failure 14.10 10.12 43 214850 6218 79523277
Blood ethanol increased 14.09 10.12 13 214880 680 79528815
Sweat gland disorder 14.01 10.12 8 214885 195 79529300
Laryngeal oedema 14.01 10.12 51 214842 8078 79521417
Pneumonitis chemical 14.00 10.12 11 214882 461 79529034
Respiratory tract congestion 13.99 10.12 20 214873 19934 79509561
Haematemesis 13.95 10.12 208 214685 52056 79477439
Blood catecholamines increased 13.94 10.12 5 214888 38 79529457
Tumour haemorrhage 13.93 10.12 33 214860 4111 79525384
Manipulation 13.89 10.12 6 214887 78 79529417
Deformity 13.88 10.12 57 214836 9548 79519947
Brain herniation 13.87 10.12 48 214845 7415 79522080
Hypotonia 13.84 10.12 70 214823 12800 79516695
Medical device site fistula 13.83 10.12 5 214888 39 79529456
Metabolic encephalopathy 13.79 10.12 55 214838 9092 79520403
Mucormycosis 13.74 10.12 3 214890 8466 79521029
Respiratory tract infection bacterial 13.71 10.12 22 214871 2055 79527440
Motor dysfunction 13.71 10.12 77 214816 14656 79514839
Interstitial lung disease 13.70 10.12 217 214676 112383 79417112
Pancreatitis acute 13.66 10.12 78 214815 49526 79479969
Facial nerve disorder 13.64 10.12 13 214880 709 79528786
Post procedural haematoma 13.64 10.12 24 214869 2418 79527077
End stage renal disease 13.61 10.12 8 214885 12212 79517283
Lung disorder 13.58 10.12 145 214748 80412 79449083
Vitamin K deficiency 13.55 10.12 13 214880 715 79528780
Pneumothorax 13.49 10.12 126 214767 28197 79501298
Nerve stimulation test abnormal 13.48 10.12 4 214889 15 79529480
Therapy non-responder 13.30 10.12 172 214721 92133 79437362
Listless 13.25 10.12 31 214862 3830 79525665
Tracheal pain 13.20 10.12 5 214888 45 79529450
Breast cancer metastatic 13.20 10.12 52 214841 8550 79520945
Drug screen negative 13.18 10.12 9 214884 303 79529192
Eye disorder 13.18 10.12 27 214866 23385 79506110
Respiratory tract infection 13.18 10.12 77 214816 48612 79480883
Myocarditis 13.16 10.12 24 214869 21709 79507786
Visual field defect 13.15 10.12 4 214889 9041 79520454
Euthyroid sick syndrome 13.12 10.12 6 214887 90 79529405
Impaired gastric emptying 13.09 10.12 59 214834 10294 79519201
Bacterial infection 13.04 10.12 42 214851 31238 79498257
Carcinoembryonic antigen 13.00 10.12 6 214887 92 79529403
Seasonal allergy 13.00 10.12 15 214878 16391 79513104
Pain 12.98 10.12 1680 213213 702122 78827373
Febrile neutropenia 12.97 10.12 500 214393 230499 79298996
Faeces discoloured 12.93 10.12 38 214855 29089 79500406
Capillary nail refill test abnormal 12.92 10.12 5 214888 48 79529447
Hypophonesis 12.91 10.12 4 214889 18 79529477
Cholelithiasis 12.85 10.12 86 214807 52578 79476917
Osteoarthritis 12.84 10.12 162 214731 87147 79442348
Carbohydrate antigen 15-3 12.83 10.12 6 214887 95 79529400
Catecholamine crisis 12.83 10.12 5 214888 49 79529446
Post laminectomy syndrome 12.82 10.12 9 214884 317 79529178
Hemiplegic migraine 12.77 10.12 6 214887 96 79529399
Wound dehiscence 12.77 10.12 43 214850 6552 79522943
Skin cancer 12.75 10.12 13 214880 15027 79514468
Chronic obstructive pulmonary disease 12.74 10.12 158 214735 85261 79444234
Laryngeal cancer metastatic 12.74 10.12 5 214888 50 79529445
Dermal absorption impaired 12.73 10.12 4 214889 19 79529476
Vaginal flatulence 12.72 10.12 24 214869 2551 79526944
Mechanical ventilation 12.72 10.12 25 214868 2739 79526756
Atelectasis 12.72 10.12 138 214755 32119 79497376
Hippocampal atrophy 12.69 10.12 3 214890 3 79529492
Throat tightness 12.69 10.12 36 214857 27871 79501624
Monoplegia 12.68 10.12 31 214862 3940 79525555
Large intestine anastomosis 12.66 10.12 6 214887 98 79529397
Gouty tophus 12.65 10.12 10 214883 423 79529072
Sputum increased 12.64 10.12 34 214859 4579 79524916
Therapy partial responder 12.64 10.12 17 214876 17380 79512115
Procedural vomiting 12.64 10.12 13 214880 778 79528717
Second primary malignancy 12.63 10.12 12 214881 14338 79515157
Mean arterial pressure increased 12.57 10.12 5 214888 52 79529443
Appendicitis 12.56 10.12 23 214870 20771 79508724
International normalised ratio increased 12.53 10.12 157 214736 84564 79444931
Optic neuritis 12.48 10.12 5 214888 9515 79519980
Product packaging issue 12.47 10.12 16 214877 1217 79528278
Metastases to meninges 12.45 10.12 29 214864 3572 79525923
Lagophthalmos 12.45 10.12 10 214883 433 79529062
Bronchiectasis 12.45 10.12 26 214867 22360 79507135
Hypovolaemia 12.42 10.12 86 214807 17605 79511890
Leukopenia 12.41 10.12 230 214663 116283 79413212
Cytomegalovirus infection reactivation 12.41 10.12 4 214889 8712 79520783
Antinuclear antibody positive 12.39 10.12 3 214890 7887 79521608
Acute chest syndrome 12.37 10.12 18 214875 1543 79527952
Dislocation of vertebra 12.36 10.12 3 214890 7877 79521618
Ketoacidosis 12.30 10.12 3 214890 7851 79521644
Hot flush 12.22 10.12 92 214801 54785 79474710
Melaena 12.22 10.12 105 214788 60785 79468710
Procedural haemorrhage 12.21 10.12 34 214859 4672 79524823
Forced expiratory volume decreased 12.21 10.12 3 214890 7811 79521684
Low density lipoprotein increased 12.20 10.12 4 214889 8618 79520877
Rales 12.19 10.12 22 214871 19979 79509516
Pneumocephalus 12.15 10.12 9 214884 345 79529150
Product dose omission in error 12.15 10.12 3 214890 7785 79521710
Thyroid disorder 12.13 10.12 12 214881 14067 79515428
Cerebral ischaemia 12.12 10.12 61 214832 11134 79518361
Influenza like illness 12.12 10.12 129 214764 71578 79457917
Meningococcal bacteraemia 12.10 10.12 4 214889 23 79529472
Sedation complication 12.10 10.12 78 214815 15591 79513904
Gastrointestinal infection 12.08 10.12 8 214885 11453 79518042
Lymphopenia 12.07 10.12 42 214851 30515 79498980
Gastroenteritis viral 12.07 10.12 31 214862 24800 79504695
Abdominal compartment syndrome 12.06 10.12 18 214875 1579 79527916
Bronchial disorder 12.05 10.12 23 214870 2466 79527029
Uterine atony 12.03 10.12 7 214886 177 79529318
Skin plaque 12.02 10.12 7 214886 10738 79518757
Unintentional medical device removal 11.98 10.12 3 214890 7709 79521786
Procedural nausea 11.95 10.12 13 214880 830 79528665
Burkholderia test positive 11.95 10.12 11 214882 574 79528921
Foreign body 11.92 10.12 25 214868 2869 79526626
Diplopia 11.92 10.12 48 214845 33418 79496077
Ankle fracture 11.91 10.12 17 214876 16952 79512543
Cytopenia 11.91 10.12 23 214870 20360 79509135
Muscle spasticity 11.89 10.12 25 214868 21450 79508045
Skin disorder 11.89 10.12 49 214844 33894 79495601
Skin necrosis 11.84 10.12 19 214874 18068 79511427
Monoparesis 11.84 10.12 28 214865 3483 79526012
Exposure via breast milk 11.81 10.12 14 214879 982 79528513
Glaucoma 11.81 10.12 22 214871 19739 79509756
Anxiety 11.79 10.12 799 214094 247713 79281782
Rash pustular 11.78 10.12 8 214885 11303 79518192
Tubulointerstitial nephritis 11.71 10.12 58 214835 38177 79491318
Bone marrow failure 11.71 10.12 85 214808 51022 79478473
Metastatic neoplasm 11.71 10.12 35 214858 5007 79524488
Procedural pain 11.66 10.12 104 214789 22980 79506515
Intervertebral disc compression 11.65 10.12 16 214877 1300 79528195
Harlequin syndrome 11.65 10.12 5 214888 64 79529431
Cardiac disorder 11.64 10.12 117 214776 65640 79463855
Proctitis 11.63 10.12 41 214852 6391 79523104
Decerebrate posture 11.62 10.12 7 214886 189 79529306
Oesophageal intramural haematoma 11.62 10.12 6 214887 119 79529376
Plasmacytoma 11.61 10.12 32 214861 4371 79525124
Pharyngitis 11.61 10.12 27 214866 22348 79507147
Slow response to stimuli 11.60 10.12 19 214874 1806 79527689
Pupillary reflex impaired 11.59 10.12 27 214866 3326 79526169
Haematuria traumatic 11.59 10.12 7 214886 190 79529305
Sarcoidosis 11.56 10.12 4 214889 8331 79521164
Septic shock 11.54 10.12 422 214471 122379 79407116
Electrocardiogram T wave alternans 11.51 10.12 5 214888 66 79529429
Sympatholysis 11.48 10.12 3 214890 6 79529489
Onychomycosis 11.40 10.12 4 214889 8257 79521238
Clinical trial participant 11.39 10.12 6 214887 124 79529371
Myopathy 11.33 10.12 24 214869 20539 79508956
Myocardial stunning 11.33 10.12 7 214886 198 79529297
Muscle atrophy 11.33 10.12 60 214833 11172 79518323
Fear of death 11.33 10.12 17 214876 1499 79527996
Prescribed overdose 11.30 10.12 58 214835 37825 79491670
Nausea 11.29 10.12 2823 212070 954373 78575122
Abscess neck 11.28 10.12 15 214878 1182 79528313
Spinal cord oedema 11.28 10.12 9 214884 386 79529109
Drug tolerance decreased 11.25 10.12 11 214882 12967 79516528
Refusal of treatment by relative 11.23 10.12 12 214881 751 79528744
Hypogammaglobulinaemia 11.20 10.12 11 214882 12940 79516555
Laryngeal obstruction 11.18 10.12 6 214887 129 79529366
Red blood cell count decreased 11.18 10.12 100 214793 57413 79472082
Vein disorder 11.13 10.12 35 214858 5147 79524348
Hypoperfusion 11.11 10.12 23 214870 2616 79526879
Paralysis recurrent laryngeal nerve 11.10 10.12 6 214887 131 79529364
Alanine aminotransferase abnormal 11.07 10.12 5 214888 8862 79520633
Disturbance in social behaviour 11.07 10.12 34 214859 4936 79524559
Gastrointestinal motility disorder 11.05 10.12 39 214854 6083 79523412
Gross motor delay 11.02 10.12 6 214887 133 79529362
Product communication issue 11.02 10.12 14 214879 1055 79528440
Ocular hyperaemia 10.99 10.12 39 214854 28167 79501328
Cardiac murmur 10.96 10.12 16 214877 15808 79513687
Anion gap abnormal 10.92 10.12 11 214882 642 79528853
Bile output abnormal 10.87 10.12 4 214889 33 79529462
Substance use disorder 10.82 10.12 13 214880 925 79528570
Generalised onset non-motor seizure 10.82 10.12 5 214888 77 79529418
Premature separation of placenta 10.81 10.12 15 214878 1231 79528264
Hypothermia 10.74 10.12 101 214792 22645 79506850
Shock 10.74 10.12 171 214722 43377 79486118
Pancreatic carcinoma 10.74 10.12 68 214825 13509 79515986
Intentional overdose 10.72 10.12 211 214682 105749 79423746
Hydrocephalus 10.72 10.12 50 214843 8850 79520645
Documented hypersensitivity to administered product 10.72 10.12 13 214880 934 79528561
Bronchopulmonary aspergillosis 10.70 10.12 28 214865 22266 79507229
Gonadotrophin deficiency 10.66 10.12 4 214889 35 79529460
Ovarian cyst 10.66 10.12 11 214882 12644 79516851
Drug dose titration not performed 10.64 10.12 12 214881 798 79528697
Excessive dynamic airway collapse 10.62 10.12 3 214890 9 79529486
Bone cement implantation syndrome 10.62 10.12 3 214890 9 79529486
Device use error 10.58 10.12 3 214890 7098 79522397
Dysphonia 10.57 10.12 100 214793 56772 79472723
Treatment noncompliance 10.55 10.12 90 214803 52178 79477317
Implant site extravasation 10.53 10.12 12 214881 807 79528688
Respiratory paralysis 10.48 10.12 5 214888 83 79529412
Gout 10.48 10.12 33 214860 24716 79504779
Physical product label issue 10.47 10.12 4 214889 37 79529458
Oculogyric crisis 10.46 10.12 24 214869 2928 79526567
Neuroleptic malignant syndrome 10.45 10.12 117 214776 27442 79502053
Conjunctivitis 10.39 10.12 35 214858 25680 79503815
Uterine hypotonus 10.37 10.12 5 214888 85 79529410
Parkinsonism 10.32 10.12 18 214875 16566 79512929
Intraocular pressure increased 10.29 10.12 6 214887 9199 79520296
Nephrotic syndrome 10.24 10.12 9 214884 11165 79518330
Mouth ulceration 10.24 10.12 61 214832 38333 79491162
Femoral nerve injury 10.19 10.12 4 214889 40 79529455
Fibrinolysis 10.17 10.12 5 214888 89 79529406
Proteinuria 10.13 10.12 49 214844 32453 79497042
Gynaecomastia 10.12 10.12 4 214889 7677 79521818
Blood creatine phosphokinase MB increased 10.12 10.12 23 214870 2788 79526707

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 48.98 30.68 11 298 3 89480
Intraventricular haemorrhage 32.49 30.68 14 295 142 89341

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 D000759 Adjuvants, Anesthesia
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
MeSH PA D000777 Anesthetics
MeSH PA D018686 Anesthetics, Intravenous
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009294 Narcotics
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
FDA MoA N0000175684 Full Opioid Agonists
FDA EPC N0000175690 Opioid Agonist
CHEBI has role CHEBI:35482 narcotic analgesic
CHEBI has role CHEBI:55322 mu-opioid agonists
CHEBI has role CHEBI:38867 anaesthetic
CHEBI has role CHEBI:38877 intravenous anesthetics
CHEBI has role CHEBI:60807 anaesthestic adjuvant
CHEBI has role CHEBI:60809 adjuvants

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
EQ 0.1MG BASE LAZANDA BTCP PHARMA N022569 June 30, 2011 DISCN SPRAY, METERED NASAL 8889176 Jan. 16, 2024 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE LAZANDA BTCP PHARMA N022569 June 30, 2011 DISCN SPRAY, METERED NASAL 8889176 Jan. 16, 2024 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.1MG BASE LAZANDA BTCP PHARMA N022569 June 30, 2011 DISCN SPRAY, METERED NASAL 8216604 Oct. 3, 2024 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE LAZANDA BTCP PHARMA N022569 June 30, 2011 DISCN SPRAY, METERED NASAL 8216604 Oct. 3, 2024 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
0.1MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.1MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.1MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
0.2MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.2MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.2MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
0.4MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.4MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.4MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
0.6MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.6MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.6MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
0.8MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.8MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.8MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
1.2MG SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 DISCN SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
1.2MG SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 DISCN SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
1.2MG SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 DISCN SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
1.6MG SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 DISCN SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
1.6MG SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 DISCN SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
1.6MG 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 SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
0.2MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
0.4MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
0.6MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
0.8MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 DISCN SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
1.2MG SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 DISCN SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
1.6MG 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
D(3) dopamine receptor GPCR Ki 4.58 CHEMBL
D(4) dopamine receptor GPCR Ki 6.26 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
7V7 PDB_CHEM_ID
CHEMBL688 ChEMBL_ID
CHEMBL596 ChEMBL_ID
DB00813 DRUGBANK_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
CHEMBL1201159 ChEMBL_ID

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 0093-7865 LOZENGE 200 ug ORAL NDA authorized generic 33 sections
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 0093-7866 LOZENGE 400 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 0093-7867 LOZENGE 600 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 0093-7868 LOZENGE 800 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 0093-7869 LOZENGE 1200 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 Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7870 LOZENGE 1600 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 34 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9119 PATCH 12 ug TRANSDERMAL ANDA 34 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9121 PATCH 25 ug TRANSDERMAL ANDA 34 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9121 PATCH 25 ug TRANSDERMAL ANDA 34 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9122 PATCH 50 ug TRANSDERMAL ANDA 34 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9122 PATCH 50 ug TRANSDERMAL ANDA 34 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9123 PATCH 75 ug TRANSDERMAL ANDA 34 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9123 PATCH 75 ug TRANSDERMAL ANDA 34 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9124 PATCH 100 ug TRANSDERMAL ANDA 34 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9124 PATCH 100 ug TRANSDERMAL ANDA 34 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9125 PATCH 37.50 ug TRANSDERMAL ANDA 34 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9125 PATCH 37.50 ug TRANSDERMAL ANDA 34 sections