fentanyl 🐶 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) 25 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 8 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.00 µM/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
Feb. 19, 1968 FDA AKORN
June 29, 2020 PMDA Hisamitsu Pharmaceutical Co., Inc.

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 2964.08 10.03 1905 132929 65705 56091528
Toxicity to various agents 1086.10 10.03 1934 132900 222630 55934603
Product adhesion issue 750.27 10.03 312 134522 4171 56153062
Respiratory arrest 618.15 10.03 543 134291 30082 56127151
Death 580.30 10.03 1965 132869 339461 55817772
Serotonin syndrome 569.63 10.03 487 134347 26003 56131230
Cardiac arrest 562.81 10.03 852 133982 85462 56071771
Respiratory depression 535.15 10.03 347 134487 12088 56145145
Cardio-respiratory arrest 493.48 10.03 635 134199 54686 56102547
Inadequate analgesia 440.57 10.03 184 134650 2487 56154746
Product quality issue 400.31 10.03 435 134399 31301 56125932
Drug withdrawal syndrome 389.96 10.03 390 134444 25467 56131766
Overdose 387.96 10.03 812 134022 105018 56052215
Systemic lupus erythematosus 350.54 10.03 20 134814 180058 55977175
Incorrect route of product administration 335.14 10.03 329 134505 21000 56136233
Alopecia 333.36 10.03 143 134691 293315 55863918
Rheumatoid arthritis 324.22 10.03 265 134569 382339 55774894
Accidental overdose 307.39 10.03 308 134526 20153 56137080
Synovitis 301.81 10.03 22 134812 161283 55995950
Glossodynia 299.58 10.03 16 134818 152442 56004791
Hand deformity 296.69 10.03 5 134829 134487 56022746
Drug interaction 290.61 10.03 1131 133703 208624 55948609
Anaphylactic reaction 287.67 10.03 511 134323 58484 56098749
Product prescribing error 285.74 10.03 314 134520 22872 56134361
Intentional product misuse 285.16 10.03 472 134362 51032 56106201
Arthropathy 255.22 10.03 81 134753 200194 55957039
Infusion related reaction 246.54 10.03 96 134738 208835 55948398
Maternal exposure during delivery 238.67 10.03 93 134741 1037 56156196
Product complaint 236.15 10.03 208 134626 11552 56145681
Joint swelling 226.84 10.03 216 134618 289584 55867649
Hypotension 224.78 10.03 1188 133646 249320 55907913
Wrong technique in product usage process 224.36 10.03 456 134378 57712 56099521
Drug dependence 217.22 10.03 269 134565 22264 56134969
Abdominal discomfort 210.82 10.03 212 134622 277062 55880171
Pericarditis 209.14 10.03 13 134821 108910 56048323
Unresponsive to stimuli 206.28 10.03 313 134521 31412 56125821
Bradycardia 200.01 10.03 476 134358 67028 56090205
Wound 199.80 10.03 44 134790 138760 56018473
Apnoea 193.16 10.03 151 134683 7091 56150142
Withdrawal syndrome 187.02 10.03 226 134608 18236 56138997
Somnolence 181.50 10.03 824 134010 162589 55994644
Rash 181.44 10.03 592 134242 492455 55664778
Sinusitis 180.96 10.03 126 134708 197455 55959778
Anaesthetic complication 177.95 10.03 86 134748 1666 56155567
Swelling 171.39 10.03 193 134641 239578 55917655
Delayed recovery from anaesthesia 169.40 10.03 65 134769 693 56156540
Contraindicated product administered 165.10 10.03 123 134711 186163 55971070
Nasopharyngitis 163.28 10.03 173 134661 220786 55936447
Accidental exposure to product by child 161.13 10.03 71 134763 1102 56156131
Arthralgia 160.26 10.03 639 134195 501030 55656203
Helicobacter infection 156.48 10.03 4 134830 73264 56083969
Miosis 155.70 10.03 128 134706 6464 56150769
Drug intolerance 154.91 10.03 247 134587 264571 55892662
Delirium 149.54 10.03 321 134513 42196 56115037
Hepatic enzyme increased 149.50 10.03 115 134719 171269 55985964
Treatment failure 147.79 10.03 115 134719 170277 55986956
Procedural hypotension 143.03 10.03 65 134769 1089 56156144
Fatigue 137.67 10.03 1219 133615 787333 55369900
Malignant neoplasm progression 135.39 10.03 436 134398 73151 56084082
Lower respiratory tract infection 130.03 10.03 56 134778 114738 56042495
Myoclonus 129.97 10.03 171 134663 15032 56142201
Cough 125.86 10.03 272 134562 259689 55897544
Headache 125.48 10.03 805 134029 558239 55598994
Hyperaesthesia 122.13 10.03 126 134708 8531 56148702
Depressed level of consciousness 120.24 10.03 352 134482 56081 56101152
Neuromuscular block prolonged 117.93 10.03 45 134789 472 56156761
Application site rash 117.65 10.03 73 134761 2350 56154883
Pleural fibrosis 116.57 10.03 83 134751 3376 56153857
Presbyacusis 114.29 10.03 76 134758 2762 56154471
Respiratory rate decreased 113.93 10.03 80 134754 3182 56154051
Completed suicide 113.87 10.03 626 134208 133207 56024026
Hypersensitivity 112.30 10.03 283 134551 256125 55901108
White blood cell count abnormal 112.28 10.03 101 134733 5766 56151467
Muscle injury 111.60 10.03 3 134831 52497 56104736
Peripheral swelling 110.80 10.03 249 134585 234477 55922756
Folliculitis 110.39 10.03 5 134829 54974 56102259
Respiratory acidosis 108.02 10.03 101 134733 6062 56151171
Irritable bowel syndrome 106.29 10.03 18 134816 68440 56088793
Injection site pain 105.43 10.03 76 134758 117042 56040191
Deafness neurosensory 102.21 10.03 87 134747 4611 56152622
Bradypnoea 101.41 10.03 74 134760 3129 56154104
Discomfort 99.15 10.03 116 134718 141645 56015588
Blood potassium increased 96.56 10.03 159 134675 17102 56140131
Bronchospasm 95.40 10.03 150 134684 15519 56141714
Agitation 95.00 10.03 323 134511 55713 56101520
Weight increased 93.38 10.03 263 134571 229440 55927793
Pulmonary oedema 93.12 10.03 302 134532 50841 56106392
Coma 90.08 10.03 331 134503 59324 56097909
Myoglobin urine present 90.02 10.03 38 134796 528 56156705
Product use issue 89.69 10.03 195 134639 185846 55971387
Application site erythema 89.63 10.03 80 134754 4520 56152713
Pleural thickening 88.69 10.03 64 134770 2659 56154574
Blood magnesium increased 88.53 10.03 66 134768 2885 56154348
Medication error 87.25 10.03 261 134573 42074 56115159
Oxygen saturation decreased 84.91 10.03 395 134439 78672 56078561
Hyperthermia malignant 82.78 10.03 39 134795 712 56156521
Therapeutic product effect incomplete 80.52 10.03 81 134753 105950 56051283
Labile blood pressure 79.67 10.03 50 134784 1643 56155590
Pulseless electrical activity 79.46 10.03 91 134743 6933 56150300
Stress cardiomyopathy 77.90 10.03 98 134736 8238 56148995
Circulatory collapse 77.70 10.03 161 134673 20642 56136591
Anaphylactic shock 77.42 10.03 165 134669 21575 56135658
Hypoxia 77.16 10.03 294 134540 53603 56103630
Hypoventilation 77.02 10.03 72 134762 4320 56152913
Psoriatic arthropathy 76.31 10.03 41 134793 73967 56083266
Application site vesicles 76.27 10.03 45 134789 1320 56155913
Constipation 75.77 10.03 778 134056 201165 55956068
Application site pruritus 75.57 10.03 67 134767 3752 56153481
Poisoning 74.35 10.03 120 134714 12693 56144540
Tachycardia 73.75 10.03 470 134364 105406 56051827
Breakthrough pain 73.65 10.03 42 134792 1154 56156079
Neoplasm progression 73.32 10.03 205 134629 31811 56125422
Condition aggravated 72.95 10.03 505 134329 344393 55812840
Hip arthroplasty 72.95 10.03 5 134829 38618 56118615
Encephalopathy 72.05 10.03 217 134617 35108 56122125
C-reactive protein abnormal 71.82 10.03 4 134830 36805 56120428
Pruritus 70.25 10.03 457 134377 316166 55841067
Ill-defined disorder 69.18 10.03 39 134795 68504 56088729
Faecaloma 68.77 10.03 87 134747 7354 56149879
Injection site erythema 68.72 10.03 51 134783 77397 56079836
Respiratory failure 68.70 10.03 426 134408 94636 56062597
Knee arthroplasty 67.90 10.03 12 134822 44247 56112986
Drug diversion 67.82 10.03 35 134799 784 56156449
Application site reaction 67.64 10.03 33 134801 653 56156580
Urinary retention 67.51 10.03 183 134651 27891 56129342
Ventricular tachycardia 66.91 10.03 134 134700 16767 56140466
Hypermobility syndrome 65.99 10.03 34 134800 759 56156474
Application site irritation 65.95 10.03 44 134790 1608 56155625
Sedation 65.42 10.03 208 134626 34646 56122587
Drug ineffective 64.23 10.03 1695 133139 917294 55239939
Intercepted product dispensing error 64.15 10.03 19 134815 82 56157151
Epigastric discomfort 64.11 10.03 77 134757 6171 56151062
Blister 64.09 10.03 101 134733 108786 56048447
Fear 63.63 10.03 122 134712 14786 56142447
Injection site reaction 63.49 10.03 24 134810 53223 56104010
Blood pressure decreased 63.38 10.03 295 134539 58755 56098478
Opiates positive 62.00 10.03 26 134808 355 56156878
Infusion site coldness 61.22 10.03 22 134812 192 56157041
Device expulsion 60.38 10.03 3 134831 30446 56126787
Muscle rigidity 59.29 10.03 98 134736 10573 56146660
Multiple organ dysfunction syndrome 59.14 10.03 267 134567 52503 56104730
Abortion spontaneous 58.76 10.03 16 134818 43737 56113496
Toxic leukoencephalopathy 58.58 10.03 30 134804 661 56156572
Type 2 diabetes mellitus 57.78 10.03 20 134814 46842 56110391
Hallucination 57.58 10.03 252 134582 48897 56108336
Brain oedema 57.13 10.03 109 134725 13162 56144071
Stomatitis 57.06 10.03 128 134706 120682 56036551
Osteopenia 57.04 10.03 131 134703 18010 56139223
Asthma 57.00 10.03 115 134719 112655 56044578
Restlessness 56.77 10.03 166 134668 26420 56130813
Drug abuser 56.26 10.03 50 134784 2809 56154424
Mental status changes 55.69 10.03 207 134627 37294 56119939
Vomiting 55.09 10.03 1572 133262 496656 55660577
Hyperhidrosis 54.98 10.03 400 134434 93688 56063545
Blood cholesterol increased 53.34 10.03 57 134777 72522 56084711
Toxic encephalopathy 52.63 10.03 68 134766 5870 56151363
Gamma-glutamyltransferase decreased 52.62 10.03 22 134812 298 56156935
Drug use disorder 51.99 10.03 60 134774 4609 56152624
Therapeutic product effect increased 51.94 10.03 32 134802 1017 56156216
Psoriasis 51.73 10.03 89 134745 92603 56064630
Procedural complication 51.62 10.03 62 134772 4969 56152264
Therapy naive 51.59 10.03 13 134821 25 56157208
Post procedural complication 51.34 10.03 115 134719 15551 56141682
Generalised tonic-clonic seizure 51.27 10.03 164 134670 27402 56129831
Pain in extremity 51.00 10.03 461 134373 296970 55860263
Troponin increased 50.27 10.03 81 134753 8554 56148679
Off label use 50.23 10.03 985 133849 555195 55602038
Vaginal flatulence 49.97 10.03 27 134807 666 56156567
Bone cyst 49.89 10.03 41 134793 2069 56155164
Application site pain 49.86 10.03 54 134780 3866 56153367
Application site dermatitis 49.70 10.03 18 134816 161 56157072
Emotional distress 49.06 10.03 170 134664 29593 56127640
Therapeutic product effect prolonged 48.67 10.03 21 134813 309 56156924
Haemodynamic instability 48.31 10.03 78 134756 8251 56148982
Drug screen positive 48.11 10.03 50 134784 3414 56153819
Renal failure 47.92 10.03 439 134395 110061 56047172
Dependence 47.63 10.03 39 134795 1958 56155275
Allodynia 46.63 10.03 27 134807 764 56156469
Vasodilatation 46.49 10.03 41 134793 2280 56154953
Loss of consciousness 46.20 10.03 432 134402 108917 56048316
Anterior spinal artery syndrome 45.27 10.03 14 134820 72 56157161
Confusional state 45.21 10.03 725 134109 207430 55949803
Influenza 44.92 10.03 101 134733 95160 56062073
Amylase increased 44.88 10.03 62 134772 5709 56151524
Disorientation 44.63 10.03 190 134644 36423 56120810
Hepatic ischaemia 44.34 10.03 24 134810 594 56156639
Neuromuscular blockade 43.88 10.03 19 134815 282 56156951
Kounis syndrome 43.40 10.03 31 134803 1267 56155966
Cancer pain 43.10 10.03 44 134790 2942 56154291
Metastases to bone 42.80 10.03 123 134711 19385 56137848
Myalgia 42.69 10.03 167 134667 131858 56025375
Dehydration 42.67 10.03 574 134260 158251 55998982
Carcinoid crisis 42.52 10.03 18 134816 252 56156981
Osteosclerosis 42.35 10.03 48 134786 3615 56153618
Renal injury 42.02 10.03 76 134758 8811 56148422
Premature delivery 41.55 10.03 151 134683 26909 56130324
Renal impairment 40.93 10.03 332 134502 80381 56076852
Product counterfeit 40.69 10.03 14 134820 106 56157127
Unwanted awareness during anaesthesia 39.47 10.03 18 134816 304 56156929
Altered state of consciousness 39.26 10.03 133 134701 22888 56134345
Anhedonia 38.52 10.03 78 134756 9836 56147397
Bradycardia foetal 38.32 10.03 19 134815 390 56156843
Clonus 38.19 10.03 49 134785 4200 56153033
Red blood cell sedimentation rate increased 38.17 10.03 20 134814 36603 56120630
Prescription drug used without a prescription 37.72 10.03 34 134800 1946 56155287
Female genital tract fistula 37.58 10.03 50 134784 4442 56152791
Dystonia 37.20 10.03 88 134746 12333 56144900
Laryngospasm 37.16 10.03 40 134794 2844 56154389
Abdominal pain upper 36.68 10.03 263 134571 178050 55979183
Pulse absent 36.60 10.03 52 134782 4915 56152318
Anaesthetic complication neurological 36.29 10.03 15 134819 197 56157036
Product dose omission issue 36.09 10.03 315 134519 204438 55952795
Femoral hernia incarcerated 36.05 10.03 23 134811 778 56156455
Intentional self-injury 35.77 10.03 8 134826 24984 56132249
Product administration error 35.77 10.03 121 134713 20808 56136425
Bronchitis 35.71 10.03 143 134691 112168 56045065
Infusion site induration 35.61 10.03 24 134810 892 56156341
Horner's syndrome 35.16 10.03 9 134825 19 56157214
Injection site swelling 34.57 10.03 32 134802 43546 56113687
Endotracheal intubation complication 34.53 10.03 18 134816 412 56156821
Mental status changes postoperative 34.35 10.03 14 134820 177 56157056
Product administered at inappropriate site 34.35 10.03 37 134797 2633 56154600
Wound infection pseudomonas 34.16 10.03 27 134807 1288 56155945
Radiculopathy 34.16 10.03 54 134780 5611 56151622
Lymphatic fistula 33.97 10.03 22 134812 764 56156469
General physical health deterioration 33.90 10.03 584 134250 169426 55987807
Exposure during pregnancy 33.48 10.03 485 134349 135857 56021376
Fibromyalgia 33.46 10.03 57 134777 59546 56097687
COVID-19 33.45 10.03 82 134752 74976 56082257
Nasal congestion 33.43 10.03 52 134782 56318 56100915
Product packaging issue 33.43 10.03 24 134810 989 56156244
Diarrhoea 33.10 10.03 1224 133610 637283 55519950
Cyanosis 33.06 10.03 98 134736 15712 56141521
Gastrointestinal disorder 33.05 10.03 148 134686 112554 56044679
Pregnancy 33.03 10.03 19 134815 33014 56124219
Injection site pruritus 33.01 10.03 31 134803 41900 56115333
Normal newborn 32.95 10.03 62 134772 7408 56149825
Airway complication of anaesthesia 32.94 10.03 14 134820 198 56157035
Seroma 32.88 10.03 31 134803 1880 56155353
Liver injury 32.88 10.03 31 134803 41817 56115416
Monoplegia 32.75 10.03 38 134796 2936 56154297
Proctitis 32.10 10.03 35 134799 2525 56154708
Pancreatic steatosis 32.09 10.03 23 134811 945 56156288
Procedural hypertension 31.98 10.03 15 134819 271 56156962
Plasma cell myeloma 31.79 10.03 206 134628 46440 56110793
Airway peak pressure increased 31.54 10.03 15 134819 280 56156953
Intestinal pseudo-obstruction 31.27 10.03 21 134813 776 56156457
Arterial haemorrhage 31.14 10.03 28 134806 1597 56155636
Wheezing 31.10 10.03 85 134749 74941 56082292
Oropharyngeal pain 31.07 10.03 100 134734 83688 56073545
Cauda equina syndrome 30.59 10.03 22 134812 909 56156324
Arachnoid web 30.42 10.03 7 134827 7 56157226
Cyst 30.42 10.03 83 134751 12695 56144538
Haematemesis 30.36 10.03 143 134691 28615 56128618
Inflammation 30.35 10.03 76 134758 68995 56088238
Tumour pain 30.34 10.03 25 134809 1266 56155967
Hepatorenal syndrome 30.32 10.03 29 134805 1791 56155442
Chest discomfort 30.10 10.03 128 134706 98729 56058504
Amnestic disorder 30.07 10.03 15 134819 312 56156921
Wrong product administered 30.05 10.03 51 134783 5621 56151612
Spinal anaesthesia 30.00 10.03 9 134825 41 56157192
Herpes zoster 29.97 10.03 88 134746 75801 56081432
Recurrence of neuromuscular blockade 29.93 10.03 11 134823 103 56157130
Palpitations 29.77 10.03 130 134704 99542 56057691
Gastrooesophageal reflux disease 29.75 10.03 101 134733 83156 56074077
Application site burn 29.12 10.03 20 134814 767 56156466
Basal cell carcinoma 29.02 10.03 12 134822 25209 56132024
Therapeutic product effect decreased 28.84 10.03 263 134571 169189 55988044
Hepatic failure 28.68 10.03 157 134677 33329 56123904
Hypoxic-ischaemic encephalopathy 28.63 10.03 41 134793 3904 56153329
Ear infection 28.55 10.03 20 134814 31275 56125958
Muscle relaxant therapy 28.54 10.03 12 134822 165 56157068
Product tampering 28.54 10.03 13 134821 219 56157014
Anorectal ulcer 28.53 10.03 9 134825 50 56157183
Postoperative delirium 28.48 10.03 10 134824 81 56157152
Mobility decreased 28.43 10.03 131 134703 98860 56058373
Accidental death 28.28 10.03 28 134806 1804 56155429
Non-consummation 28.09 10.03 9 134825 53 56157180
Drug tolerance 28.01 10.03 51 134783 5943 56151290
Nausea 27.95 10.03 2157 132677 762021 55395212
Ocular hyperaemia 27.76 10.03 9 134825 21970 56135263
Neurotoxicity 27.60 10.03 92 134742 15703 56141530
Cardiogenic shock 27.56 10.03 94 134740 16231 56141002
Product packaging quantity issue 27.48 10.03 23 134811 1191 56156042
Substance abuse 27.10 10.03 43 134791 4482 56152751
Arthritis 27.00 10.03 135 134699 99717 56057516
Systemic infection 26.75 10.03 36 134798 3233 56154000
Hypopnoea 26.52 10.03 31 134803 2414 56154819
Confusion postoperative 26.51 10.03 12 134822 199 56157034
Interstitial lung disease 26.49 10.03 61 134773 57002 56100231
Tracheal deviation 26.44 10.03 11 134823 147 56157086
Cardiac output decreased 26.41 10.03 20 134814 895 56156338
Infection 26.29 10.03 330 134504 199876 55957357
Type I hypersensitivity 26.18 10.03 31 134803 2447 56154786
Tooth loss 25.99 10.03 51 134783 6286 56150947
Ventricular fibrillation 25.93 10.03 71 134763 10881 56146352
Drug hypersensitivity 25.93 10.03 852 133982 274353 55882880
Local anaesthetic systemic toxicity 25.63 10.03 18 134816 716 56156517
Cachexia 25.61 10.03 44 134790 4898 56152335
Poor quality product administered 25.38 10.03 33 134801 2866 56154367
Spontaneous haemorrhage 25.32 10.03 13 134821 288 56156945
Anaesthetic complication pulmonary 25.27 10.03 8 134826 45 56157188
Dizziness 25.21 10.03 697 134137 375443 55781790
Multiple sclerosis relapse 25.15 10.03 43 134791 44860 56112373
Acute postoperative sialadenitis 25.13 10.03 7 134827 23 56157210
Upper respiratory tract infection 25.11 10.03 87 134747 71201 56086032
Post procedural haemorrhage 24.76 10.03 55 134779 7394 56149839
Amphetamines positive 24.72 10.03 11 134823 175 56157058
Contusion 24.70 10.03 193 134641 128237 56028996
Lethargy 24.68 10.03 209 134625 51232 56106001
Rhythm idioventricular 24.49 10.03 11 134823 179 56157054
Phrenic nerve paralysis 24.44 10.03 11 134823 180 56157053
Head titubation 24.22 10.03 18 134816 783 56156450
Visual impairment 23.88 10.03 94 134740 74108 56083125
Supraventricular tachycardia 23.74 10.03 78 134756 13213 56144020
Upper airway obstruction 23.73 10.03 16 134818 595 56156638
Pseudopolyp 23.65 10.03 12 134822 259 56156974
Drug specific antibody 23.61 10.03 27 134807 2053 56155180
Coma scale abnormal 23.52 10.03 42 134792 4821 56152412
Dyspnoea exertional 23.39 10.03 61 134773 54628 56102605
Apnoeic attack 23.37 10.03 12 134822 266 56156967
Dyskinesia 23.28 10.03 134 134700 28974 56128259
C-reactive protein increased 23.26 10.03 103 134731 78581 56078652
Myotonia 23.18 10.03 10 134824 147 56157086
Impaired healing 23.14 10.03 118 134716 86723 56070510
Exposure via ingestion 23.10 10.03 31 134803 2777 56154456
Atrioventricular block second degree 23.06 10.03 36 134798 3700 56153533
Spinal cord injury 23.02 10.03 17 134817 732 56156501
Pupil fixed 22.77 10.03 24 134810 1666 56155567
Gouty tophus 22.76 10.03 10 134824 154 56157079
Joint stiffness 22.65 10.03 31 134803 35394 56121839
Sepsis 22.56 10.03 465 134369 139375 56017858
Tachyarrhythmia 22.43 10.03 38 134796 4183 56153050
Diabetes mellitus 22.42 10.03 59 134775 52676 56104557
Osteoporosis 22.31 10.03 58 134776 51994 56105239
Musculoskeletal disorder 22.21 10.03 9 134825 19138 56138095
Sphincter of Oddi dysfunction 22.20 10.03 13 134821 376 56156857
Stridor 22.11 10.03 33 134801 3262 56153971
Cataract 22.04 10.03 57 134777 51190 56106043
Hypovolaemia 21.95 10.03 62 134772 9673 56147560
Uterine hypertonus 21.78 10.03 12 134822 308 56156925
Pituitary apoplexy 21.72 10.03 9 134825 119 56157114
Left ventricle outflow tract obstruction 21.53 10.03 11 134823 241 56156992
Application site perspiration 21.47 10.03 6 134828 20 56157213
Opisthotonus 21.36 10.03 12 134822 320 56156913
Disturbance in social behaviour 21.18 10.03 31 134803 3010 56154223
Haemarthrosis 21.16 10.03 31 134803 3013 56154220
Potentiating drug interaction 20.81 10.03 36 134798 4030 56153203
Abscess neck 20.77 10.03 15 134819 624 56156609
Dyspnoea 20.72 10.03 1185 133649 591392 55565841
Gastrointestinal scarring 20.70 10.03 11 134823 262 56156971
Cerebrovascular accident 20.60 10.03 146 134688 99124 56058109
Anaphylactoid reaction 20.56 10.03 33 134801 3473 56153760
Pneumothorax 20.37 10.03 80 134754 14787 56142446
Vascular resistance systemic decreased 20.15 10.03 8 134826 94 56157139
Exposure to extreme temperature 20.15 10.03 4 134830 0 56157233
Liver disorder 20.14 10.03 48 134786 44322 56112911
Anticholinergic syndrome 20.11 10.03 24 134810 1910 56155323
Hyperreflexia 20.03 10.03 41 134793 5209 56152024
Skin sensitisation 19.98 10.03 16 134818 778 56156455
Tenosynovitis 19.96 10.03 3 134831 12458 56144775
Mean arterial pressure decreased 19.84 10.03 9 134825 150 56157083
Post-traumatic neck syndrome 19.68 10.03 24 134810 1954 56155279
Methaemoglobinaemia 19.54 10.03 25 134809 2137 56155096
Hypercreatininaemia 19.49 10.03 12 134822 381 56156852
Hypertonia 19.35 10.03 35 134799 4057 56153176
Respiratory distress 19.27 10.03 136 134698 31531 56125702
Loss of personal independence in daily activities 19.26 10.03 115 134719 81254 56075979
Rhinorrhoea 19.16 10.03 71 134763 56966 56100267
Retinal detachment 19.03 10.03 41 134793 5400 56151833
Brain injury 19.00 10.03 45 134789 6310 56150923
Progressive multifocal leukoencephalopathy 18.99 10.03 3 134831 12010 56145223
Eye irritation 18.95 10.03 11 134823 19017 56138216
Transient ischaemic attack 18.94 10.03 32 134802 33545 56123688
Mean arterial pressure increased 18.81 10.03 5 134829 13 56157220
Metabolic acidosis 18.69 10.03 163 134671 40291 56116942
Listless 18.58 10.03 27 134807 2605 56154628
Hypercapnia 18.51 10.03 39 134795 5057 56152176
Dental caries 18.46 10.03 60 134774 10108 56147125
Application site erosion 18.45 10.03 9 134825 178 56157055
Vasoconstriction 18.36 10.03 13 134821 524 56156709
Vaccination site reaction 18.34 10.03 8 134826 121 56157112
Generalised onset non-motor seizure 18.29 10.03 5 134829 15 56157218
Acute respiratory distress syndrome 18.24 10.03 102 134732 21824 56135409
Tryptase increased 18.18 10.03 11 134823 338 56156895
Therapeutic response decreased 18.17 10.03 65 134769 52693 56104540
Deformity 18.15 10.03 60 134774 10195 56147038
Accidental exposure to product 18.13 10.03 111 134723 24536 56132697
Blood pressure diastolic abnormal 18.11 10.03 3 134831 11595 56145638
Anaesthetic complication cardiac 18.05 10.03 5 134829 16 56157217
Drug screen negative 18.03 10.03 10 134824 260 56156973
Paraplegia 18.03 10.03 26 134808 2491 56154742
Injection site bruising 18.02 10.03 41 134793 38480 56118753
Facial nerve disorder 17.97 10.03 13 134821 542 56156691
Paralysis 17.96 10.03 55 134779 8977 56148256
Metastatic neoplasm 17.91 10.03 33 134801 3880 56153353
Gram stain positive 17.84 10.03 6 134828 42 56157191
Spinal epidural haematoma 17.77 10.03 17 134817 1050 56156183
Blood lactate dehydrogenase increased 17.74 10.03 97 134737 20578 56136655
Postpartum haemorrhage 17.69 10.03 22 134812 1827 56155406
Acute respiratory failure 17.65 10.03 131 134703 30863 56126370
Coagulopathy 17.56 10.03 90 134744 18626 56138607
Myelosuppression 17.51 10.03 10 134824 17445 56139788
Manufacturing production issue 17.38 10.03 4 134830 4 56157229
Pancreatic carcinoma metastatic 17.36 10.03 24 134810 2211 56155022
Diabetic ketoacidosis 17.29 10.03 12 134822 18859 56138374
Posturing 17.27 10.03 12 134822 469 56156764
Nephrolithiasis 17.25 10.03 40 134794 37295 56119938
Retinopathy of prematurity 17.22 10.03 11 134823 373 56156860
Mydriasis 17.18 10.03 62 134772 11009 56146224
Myocardial depression 17.09 10.03 12 134822 477 56156756
Metastases to meninges 17.07 10.03 24 134810 2246 56154987
Decorticate posture 16.96 10.03 10 134824 293 56156940
Blood pressure immeasurable 16.88 10.03 17 134817 1118 56156115
Electrocardiogram ST segment elevation 16.87 10.03 31 134803 3638 56153595
Throat irritation 16.79 10.03 33 134801 32650 56124583
Grip strength decreased 16.76 10.03 9 134825 16247 56140986
Therapeutic response unexpected 16.72 10.03 83 134751 16961 56140272
Heavy menstrual bleeding 16.67 10.03 9 134825 16200 56141033
Myocardial ischaemia 16.44 10.03 65 134769 12051 56145182
Procedural nausea 16.35 10.03 14 134820 748 56156485
Documented hypersensitivity to administered product 16.35 10.03 12 134822 512 56156721
Apathy 16.34 10.03 49 134785 7905 56149328
Ileus paralytic 16.29 10.03 33 134801 4162 56153071
Vein disorder 16.28 10.03 35 134799 4602 56152631
Bulimia nervosa 16.22 10.03 11 134823 413 56156820
Mastocytosis 16.09 10.03 12 134822 525 56156708
Gaze palsy 16.08 10.03 18 134816 1337 56155896
Injection site warmth 16.03 10.03 7 134827 14236 56142997
Drug eruption 16.02 10.03 23 134811 25740 56131493
Oculogyric crisis 15.99 10.03 19 134815 1505 56155728
Endometriosis 15.95 10.03 35 134799 4667 56152566
Fluid retention 15.86 10.03 71 134763 54007 56103226
Vitamin K deficiency 15.85 10.03 11 134823 429 56156804
Joint injury 15.85 10.03 23 134811 25631 56131602
Ankylosing spondylitis 15.74 10.03 56 134778 9874 56147359
Paranoia 15.69 10.03 59 134775 10685 56146548
Non-small cell lung cancer 15.69 10.03 30 134804 3628 56153605
Breast cancer female 15.67 10.03 5 134829 12333 56144900
Quadriplegia 15.55 10.03 20 134814 1718 56155515
Tooth hypoplasia 15.55 10.03 6 134828 65 56157168
Pulmonary congestion 15.48 10.03 78 134756 16037 56141196
Oxygen saturation immeasurable 15.45 10.03 4 134830 9 56157224
Cardiac failure congestive 15.41 10.03 135 134699 87585 56069648
Limb discomfort 15.36 10.03 25 134809 26597 56130636
Wound dehiscence 15.26 10.03 34 134800 4581 56152652
Decerebrate posture 15.26 10.03 7 134827 120 56157113
Injection site rash 15.25 10.03 11 134823 16947 56140286
Balance disorder 15.17 10.03 114 134720 76406 56080827
Tachyphylaxis 15.16 10.03 9 134825 267 56156966
Intervertebral disc compression 15.16 10.03 15 134819 966 56156267
Peroneal nerve palsy postoperative 15.11 10.03 3 134831 0 56157233
Post laminectomy syndrome 15.10 10.03 9 134825 269 56156964
Ventricular hypokinesia 15.09 10.03 32 134802 4169 56153064
Pleural neoplasm 15.07 10.03 10 134824 362 56156871
Procedural vomiting 15.05 10.03 11 134823 466 56156767
Nystagmus 15.04 10.03 39 134795 5786 56151447
Reduced facial expression 15.04 10.03 20 134814 1776 56155457
Gastrointestinal mucosa hyperaemia 15.00 10.03 8 134826 192 56157041
Aortic valve stenosis 14.99 10.03 27 134807 3120 56154113
Tuberculosis 14.87 10.03 4 134830 11025 56146208
Macular degeneration 14.86 10.03 14 134820 18894 56138339
Therapy interrupted 14.85 10.03 24 134810 25601 56131632
Caesarean section 14.84 10.03 77 134757 16014 56141219
Fungal infection 14.73 10.03 36 134798 32957 56124276
Vasoplegia syndrome 14.71 10.03 17 134817 1308 56155925
Eczema 14.68 10.03 25 134809 26128 56131105
Urticaria 14.61 10.03 251 134583 144425 56012808
Oesophageal intramural haematoma 14.50 10.03 6 134828 79 56157154
Euthyroid sick syndrome 14.50 10.03 6 134828 79 56157154
Postmortem blood drug level 14.46 10.03 7 134827 136 56157097
Blood glucose increased 14.41 10.03 113 134721 75038 56082195
Adverse drug reaction 14.40 10.03 94 134740 65038 56092195
Cardiac massage 14.39 10.03 4 134830 13 56157220
Atrioventricular block complete 14.31 10.03 45 134789 7449 56149784
Pulmonary arterial hypertension 14.28 10.03 26 134808 26477 56130756
Karnofsky scale worsened 14.16 10.03 4 134830 14 56157219
Sneezing 14.12 10.03 10 134824 15550 56141683
Foetal heart rate decreased 14.10 10.03 7 134827 144 56157089
Musculoskeletal stiffness 14.09 10.03 276 134558 155731 56001502
Atrioventricular dissociation 14.09 10.03 8 134826 218 56157015
Harlequin syndrome 13.98 10.03 5 134829 43 56157190
Carbohydrate antigen 15-3 13.92 10.03 6 134828 88 56157145
Ileus 13.90 10.03 68 134766 13814 56143419
Rash pruritic 13.71 10.03 72 134762 52522 56104711
Sensitivity to weather change 13.70 10.03 41 134793 6608 56150625
Resuscitation 13.69 10.03 15 134819 1088 56156145
Carcinoembryonic antigen 13.68 10.03 6 134828 92 56157141
Air embolism 13.67 10.03 8 134826 231 56157002
Pulmonary fibrosis 13.66 10.03 32 134802 29726 56127507
Carpal tunnel syndrome 13.60 10.03 14 134820 18130 56139103
Dyspepsia 13.57 10.03 131 134703 83340 56073893
Ear pain 13.56 10.03 34 134800 30856 56126377
Productive cough 13.55 10.03 79 134755 56153 56101080
Hypermagnesaemia 13.53 10.03 14 134820 951 56156282
Unevaluable event 13.47 10.03 174 134660 47513 56109720
Procedural haemorrhage 13.47 10.03 23 134811 2548 56154685
Orthostatic hypotension 13.47 10.03 38 134796 33161 56124072
Brain death 13.46 10.03 25 134809 2958 56154275
Acute chest syndrome 13.40 10.03 12 134822 681 56156552
Pancreatic carcinoma 13.39 10.03 43 134791 7198 56150035
Bezold-Jarisch reflex 13.37 10.03 4 134830 18 56157215
Counterfeit product administered 13.37 10.03 4 134830 18 56157215
Acute lung injury 13.36 10.03 17 134817 1445 56155788
Adverse event 13.24 10.03 78 134756 55298 56101935
Toxicologic test abnormal 13.24 10.03 12 134822 692 56156541
Torsade de pointes 13.23 10.03 62 134772 12378 56144855
Intensive care unit delirium 13.23 10.03 5 134829 51 56157182
Spinal cord infarction 13.22 10.03 8 134826 246 56156987
Septic shock 13.22 10.03 212 134622 60623 56096610
Foot deformity 13.17 10.03 23 134811 23802 56133431
Laryngeal oedema 13.15 10.03 35 134799 5275 56151958
Pelvic fracture 13.09 10.03 61 134773 12152 56145081
Propofol infusion syndrome 13.07 10.03 13 134821 842 56156391
Nerve stimulation test abnormal 13.04 10.03 3 134831 3 56157230
Dermal absorption impaired 12.97 10.03 5 134829 54 56157179
Hypersomnia 12.92 10.03 75 134759 16266 56140967
Breast cancer metastatic 12.89 10.03 72 134762 15397 56141836
Implant site extravasation 12.86 10.03 10 134824 466 56156767
Coagulation time prolonged 12.81 10.03 15 134819 1170 56156063
Anuria 12.79 10.03 59 134775 11701 56145532
Blood creatinine decreased 12.74 10.03 34 134800 5132 56152101
Performance status decreased 12.74 10.03 26 134808 3297 56153936
Self-medication 12.70 10.03 22 134812 2465 56154768
Pneumonia aspiration 12.66 10.03 126 134708 32285 56124948
Hypertension 12.64 10.03 468 134366 243810 55913423
Laryngeal obstruction 12.62 10.03 6 134828 112 56157121
Hemianopia homonymous 12.59 10.03 11 134823 604 56156629
Blood ethanol increased 12.57 10.03 6 134828 113 56157120
Yawning 12.52 10.03 14 134820 1039 56156194
Panniculitis 12.48 10.03 4 134830 9838 56147395
Hypothermia 12.43 10.03 61 134773 12409 56144824
Sinus disorder 12.41 10.03 19 134815 20715 56136518
Uterine atony 12.38 10.03 7 134827 189 56157044
Foreign body 12.38 10.03 20 134814 2116 56155117
Conjunctivitis 12.37 10.03 15 134819 18045 56139188
Laryngeal stenosis 12.36 10.03 13 134821 900 56156333
Psychomotor skills impaired 12.36 10.03 20 134814 2120 56155113
Streptococcal sepsis 12.35 10.03 18 134816 1742 56155491
Status epilepticus 12.30 10.03 70 134764 15071 56142162
Sinus tachycardia 12.29 10.03 94 134740 22350 56134883
Bronchiectasis 12.28 10.03 6 134828 11428 56145805
Chorea 12.25 10.03 16 134818 1396 56155837
Arteriospasm coronary 12.21 10.03 27 134807 3620 56153613
Somatosensory evoked potentials abnormal 12.18 10.03 3 134831 5 56157228
Drug-induced liver injury 12.17 10.03 42 134792 34420 56122813
Periorbital cellulitis 12.11 10.03 11 134823 636 56156597
Narcotic bowel syndrome 12.02 10.03 6 134828 125 56157108
Eye pain 12.01 10.03 36 134798 30811 56126422
Cranial nerve disorder 11.98 10.03 10 134824 516 56156717
Sinus congestion 11.94 10.03 12 134822 15712 56141521
Sputum discoloured 11.93 10.03 10 134824 14282 56142951
Lumbosacral plexopathy 11.83 10.03 3 134831 6 56157227
Central-alveolar hypoventilation 11.83 10.03 3 134831 6 56157227
Blood albumin decreased 11.74 10.03 64 134770 13564 56143669
Depressed mood 11.73 10.03 46 134788 36313 56120920
Abnormal behaviour 11.72 10.03 86 134748 20186 56137047
Visceral congestion 11.71 10.03 8 134826 304 56156929
Uveitis 11.65 10.03 6 134828 11089 56146144
Product formulation issue 11.54 10.03 10 134824 543 56156690
Eye swelling 11.49 10.03 21 134813 21355 56135878
Cancer fatigue 11.44 10.03 5 134829 76 56157157
Ventricular dysfunction 11.41 10.03 22 134812 2677 56154556
Infection parasitic 11.40 10.03 8 134826 318 56156915
Middle insomnia 11.38 10.03 6 134828 10944 56146289
Gastric disorder 11.38 10.03 41 134793 33169 56124064
Decubitus ulcer 11.35 10.03 50 134784 9725 56147508
Shock 11.34 10.03 90 134744 21638 56135595
Product storage error 11.33 10.03 9 134825 13204 56144029
Hypotonia 11.33 10.03 46 134788 8631 56148602
Metabolic encephalopathy 11.30 10.03 33 134801 5247 56151986
Dysaesthesia pharynx 11.29 10.03 6 134828 143 56157090
Perfume sensitivity 11.28 10.03 11 134823 696 56156537
Peripheral venous disease 11.27 10.03 5 134829 10074 56147159
Leukoencephalopathy 11.24 10.03 28 134806 4054 56153179
Muscle spasms 11.23 10.03 247 134587 137124 56020109
Osteomyelitis 11.19 10.03 98 134736 24248 56132985
Malaise 11.17 10.03 745 134089 367115 55790118
Complex regional pain syndrome 11.13 10.03 19 134815 2104 56155129
Shock haemorrhagic 11.10 10.03 47 134787 8986 56148247
Incontinence 11.05 10.03 53 134781 10682 56146551
Respiratory alkalosis 11.04 10.03 21 134813 2530 56154703
Disseminated intravascular coagulation 10.99 10.03 77 134757 17808 56139425
Excessive dynamic airway collapse 10.97 10.03 3 134831 9 56157224
Obstetric procedure complication 10.97 10.03 3 134831 9 56157224
Application site laceration 10.97 10.03 3 134831 9 56157224
Hypobarism 10.97 10.03 3 134831 9 56157224
Multiple lentigines syndrome 10.96 10.03 6 134828 152 56157081
Metastatic gastric cancer 10.96 10.03 6 134828 152 56157081
Burkholderia test positive 10.94 10.03 7 134827 238 56156995
Head and neck cancer 10.93 10.03 4 134830 37 56157196
Substance use disorder 10.92 10.03 6 134828 153 56157080
Premature separation of placenta 10.92 10.03 17 134817 1743 56155490
Muscle tension dysphonia 10.88 10.03 5 134829 86 56157147
Sinus arrest 10.87 10.03 17 134817 1750 56155483
Vaginal discharge 10.86 10.03 36 134798 6127 56151106
Intestinal ischaemia 10.84 10.03 39 134795 6916 56150317
Gastrointestinal vascular malformation 10.83 10.03 4 134830 38 56157195
Neurosis 10.81 10.03 7 134827 243 56156990
Chest expansion decreased 10.74 10.03 4 134830 39 56157194
Respiratory paralysis 10.74 10.03 3 134831 10 56157223
Gestational diabetes 10.73 10.03 3 134831 8061 56149172
Lagophthalmos 10.72 10.03 8 134826 350 56156883
Extradural haematoma 10.70 10.03 16 134818 1584 56155649
Paroxysmal arrhythmia 10.65 10.03 4 134830 40 56157193
Feeling cold 10.65 10.03 87 134747 21100 56136133
Eye pruritus 10.61 10.03 11 134823 14195 56143038
Underdose 10.60 10.03 95 134739 23662 56133571
Pleural effusion 10.60 10.03 274 134560 85206 56072027
Product administered to patient of inappropriate age 10.58 10.03 22 134812 2826 56154407
Viral infection 10.58 10.03 40 134794 31906 56125327
Sopor 10.56 10.03 86 134748 20836 56136397
Prinzmetal angina 10.54 10.03 11 134823 755 56156478
Spinal cord compression 10.46 10.03 26 134808 3758 56153475
Non-cardiogenic pulmonary oedema 10.42 10.03 10 134824 620 56156613
Conversion disorder 10.41 10.03 16 134818 1622 56155611
Systemic inflammatory response syndrome 10.36 10.03 32 134802 5246 56151987
Colitis microscopic 10.35 10.03 3 134831 7872 56149361
Postoperative wound infection 10.34 10.03 47 134787 9266 56147967
Cytomegalovirus infection 10.33 10.03 19 134815 19277 56137956
Eosinophil cationic protein increased 10.31 10.03 4 134830 44 56157189
Intracranial pressure increased 10.30 10.03 29 134805 4516 56152717
Acne 10.29 10.03 22 134812 21114 56136119
Electrocardiogram ST segment depression 10.29 10.03 21 134813 2662 56154571
Hyperdynamic left ventricle 10.29 10.03 6 134828 172 56157061
Chemical peritonitis 10.20 10.03 5 134829 100 56157133
Anxiety 10.20 10.03 563 134271 192609 55964624
Brain herniation 10.18 10.03 24 134810 3356 56153877
Embolic cerebral infarction 10.15 10.03 9 134825 504 56156729
Memory impairment 10.14 10.03 146 134688 86411 56070822
Blood creatine phosphokinase increased 10.13 10.03 107 134727 27845 56129388
Lung disorder 10.12 10.03 79 134755 52518 56104715
Gingival cancer 10.12 10.03 3 134831 13 56157220
Troponin I increased 10.10 10.03 18 134816 2063 56155170
Therapy non-responder 10.09 10.03 96 134738 61259 56095974
Creatinine renal clearance decreased 10.07 10.03 12 134822 14547 56142686

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 7156.25 11.01 4124 101399 83634 31508187
Toxicity to various agents 2142.91 11.01 2814 102709 178673 31413148
Respiratory arrest 677.51 11.01 617 104906 25640 31566181
Accidental overdose 632.18 11.01 509 105014 17841 31573980
Incorrect route of product administration 586.13 11.01 406 105117 11267 31580554
Cardio-respiratory arrest 582.90 11.01 787 104736 50939 31540882
Overdose 572.47 11.01 1017 104506 83647 31508174
Product adhesion issue 565.83 11.01 207 105316 1318 31590503
Serotonin syndrome 529.48 11.01 464 105059 18309 31573512
Respiratory depression 526.50 11.01 415 105108 14095 31577726
Cardiac arrest 507.26 11.01 994 104529 88068 31503753
Intentional product misuse 347.06 11.01 523 105000 37428 31554393
Drug withdrawal syndrome 345.99 11.01 367 105156 18383 31573438
Hyperthermia malignant 273.02 11.01 133 105390 1851 31589970
Drug dependence 270.09 11.01 354 105169 22225 31569596
Unresponsive to stimuli 245.02 11.01 362 105161 25438 31566383
Miosis 237.88 11.01 210 105313 8360 31583461
Depressed level of consciousness 221.94 11.01 433 105090 38168 31553653
Anaphylactic reaction 207.01 11.01 361 105162 29192 31562629
Inadequate analgesia 205.53 11.01 122 105401 2571 31589250
Accidental exposure to product by child 186.82 11.01 94 105429 1408 31590413
Death 180.41 11.01 1911 103612 358658 31233163
Pulmonary oedema 170.35 11.01 424 105099 44078 31547743
Hyperaesthesia 167.42 11.01 124 105399 3827 31587994
Product quality issue 163.03 11.01 233 105290 15878 31575943
Delirium 147.46 11.01 384 105139 41037 31550784
Somnolence 132.53 11.01 668 104855 98777 31493044
Anaesthetic complication 132.39 11.01 66 105457 968 31590853
Amnestic disorder 121.94 11.01 41 105482 195 31591626
Delayed recovery from anaesthesia 118.51 11.01 55 105468 682 31591139
Withdrawal syndrome 117.87 11.01 169 105354 11548 31580273
Drug use disorder 113.32 11.01 99 105424 3884 31587937
Malignant neoplasm progression 111.14 11.01 539 104984 78459 31513362
Neoplasm progression 109.95 11.01 222 105301 20050 31571771
Headache 108.61 11.01 286 105237 183366 31408455
Injury 108.28 11.01 217 105306 19492 31572329
Product prescribing error 107.60 11.01 216 105307 19426 31572395
Pain 106.94 11.01 1019 104504 185740 31406081
Apnoea 105.41 11.01 117 105406 6165 31585656
Wrong technique in product usage process 102.55 11.01 293 105230 33050 31558771
Brain oedema 100.76 11.01 165 105358 12667 31579154
Product complaint 94.61 11.01 104 105419 5420 31586401
Arthralgia 93.98 11.01 230 105293 151194 31440627
Fear 93.28 11.01 139 105384 9835 31581986
Pruritus 89.28 11.01 176 105347 124991 31466830
Diarrhoea 85.37 11.01 757 104766 351652 31240169
Neuromuscular block prolonged 85.34 11.01 38 105485 425 31591396
Brain injury 81.48 11.01 99 105424 5751 31586070
Cough 80.35 11.01 209 105314 134605 31457216
Respiratory rate decreased 80.19 11.01 62 105461 2043 31589778
Rash 79.30 11.01 373 105150 201113 31390708
Anaphylactic shock 78.00 11.01 156 105367 13989 31577832
Bradypnoea 77.93 11.01 66 105457 2481 31589340
Rheumatoid arthritis 77.52 11.01 31 105492 47778 31544043
Drug interaction 75.13 11.01 1040 104483 207503 31384318
Counterfeit product administered 73.49 11.01 26 105497 148 31591673
Drug abuser 73.40 11.01 77 105446 3803 31588018
Muscle rigidity 73.33 11.01 124 105399 9773 31582048
Myoclonus 72.06 11.01 150 105373 13840 31577981
Intensive care unit acquired weakness 71.89 11.01 43 105480 919 31590902
Respiratory acidosis 71.71 11.01 83 105440 4579 31587242
Sedation complication 71.45 11.01 50 105473 1409 31590412
Treatment failure 70.26 11.01 24 105499 40768 31551053
Cardiac failure congestive 70.19 11.01 97 105426 79290 31512531
Hypotension 69.91 11.01 1011 104512 203607 31388214
Drug diversion 69.09 11.01 40 105483 803 31591018
Psoriasis 68.40 11.01 35 105488 46684 31545137
Post procedural complication 68.37 11.01 125 105398 10481 31581340
Anhedonia 67.15 11.01 102 105421 7340 31584481
Asthma 66.88 11.01 29 105494 42582 31549239
Propofol infusion syndrome 66.79 11.01 39 105484 796 31591025
Renal injury 66.62 11.01 124 105399 10541 31581280
Emotional distress 66.00 11.01 147 105376 14209 31577612
Off label use 65.93 11.01 790 104733 346484 31245337
Myalgia 65.73 11.01 97 105426 77161 31514660
Hypercapnia 64.98 11.01 73 105450 3898 31587923
Fatigue 62.30 11.01 766 104757 334440 31257381
Product counterfeit 62.22 11.01 22 105501 125 31591696
Hypoxia 62.09 11.01 331 105192 49982 31541839
Bradycardia 61.23 11.01 418 105105 68909 31522912
Product dose omission issue 59.64 11.01 168 105355 105418 31486403
Narcotic bowel syndrome 59.29 11.01 21 105502 120 31591701
Nasopharyngitis 59.26 11.01 74 105449 63171 31528650
Pulseless electrical activity 59.00 11.01 91 105432 6636 31585185
Procedural hypotension 58.93 11.01 37 105486 865 31590956
Prescription drug used without a prescription 58.67 11.01 44 105479 1384 31590437
Coma 57.97 11.01 281 105242 40869 31550952
Weight increased 57.08 11.01 119 105404 82828 31508993
Coronary artery disease 55.79 11.01 43 105480 46044 31545777
Myocardial infarction 54.61 11.01 194 105329 113260 31478561
Procedural complication 54.48 11.01 68 105455 4061 31587760
Peripheral swelling 54.11 11.01 89 105434 67776 31524045
Cyanosis 53.76 11.01 120 105403 11615 31580206
Agitation 52.30 11.01 334 105189 53835 31537986
Spinal muscular atrophy 51.93 11.01 26 105497 385 31591436
Opiates positive 51.52 11.01 28 105495 495 31591326
Dyspnoea exertional 51.27 11.01 33 105490 38804 31553017
Tachypnoea 47.92 11.01 142 105381 16341 31575480
Blood glucose increased 47.86 11.01 81 105442 61002 31530819
Anion gap 47.57 11.01 30 105493 707 31591114
Infusion related reaction 47.39 11.01 54 105469 48001 31543820
Hypoxic-ischaemic encephalopathy 47.20 11.01 65 105458 4276 31587545
Syncope 47.01 11.01 137 105386 85045 31506776
Medication error 46.42 11.01 174 105349 22598 31569223
Laryngospasm 46.33 11.01 37 105486 1279 31590542
Febrile neutropenia 44.72 11.01 231 105292 121618 31470203
Exposure to toxic agent 44.69 11.01 49 105474 2546 31589275
Oxygen saturation decreased 43.86 11.01 297 105226 48818 31543003
Confusional state 43.55 11.01 654 104869 132680 31459141
Compartment syndrome 43.53 11.01 49 105474 2622 31589199
Sinusitis 43.45 11.01 35 105488 36661 31555160
Application site reaction 43.12 11.01 23 105500 391 31591430
Tachycardia 43.06 11.01 415 105108 75792 31516029
Poisoning 42.91 11.01 102 105421 10289 31581532
Arthritis 42.40 11.01 19 105504 27366 31564455
Increased bronchial secretion 42.05 11.01 40 105483 1754 31590067
Blood cholesterol increased 41.68 11.01 4 105519 16889 31574932
Tryptase increased 40.84 11.01 18 105505 196 31591625
Blood pressure measurement 40.65 11.01 17 105506 161 31591660
Respiratory failure 40.59 11.01 516 105007 100933 31490888
COVID-19 39.98 11.01 76 105447 54745 31537076
Dizziness 39.61 11.01 448 105075 198699 31393122
Accidental death 38.42 11.01 42 105481 2175 31589646
Stress cardiomyopathy 38.37 11.01 38 105485 1752 31590069
Dyspnoea 38.28 11.01 862 104661 342617 31249204
Intentional product use issue 38.03 11.01 288 105235 49059 31542762
Anterograde amnesia 37.77 11.01 16 105507 157 31591664
Malaise 37.59 11.01 369 105154 168142 31423679
Haemodynamic instability 37.40 11.01 86 105437 8489 31583332
Bronchospasm 37.05 11.01 94 105429 9878 31581943
Negative pressure pulmonary oedema 36.97 11.01 17 105506 206 31591615
Hypoglycaemia 36.82 11.01 71 105452 50875 31540946
Cardiac failure 36.82 11.01 154 105369 85799 31506022
Anaesthetic complication neurological 36.53 11.01 19 105504 306 31591515
Airway complication of anaesthesia 36.44 11.01 15 105508 136 31591685
Therapy naive 36.17 11.01 11 105512 35 31591786
Pain in extremity 35.83 11.01 233 105290 115970 31475851
Joint swelling 35.62 11.01 78 105445 53353 31538468
Drug tolerance 35.57 11.01 43 105480 2484 31589337
Angina pectoris 35.43 11.01 28 105495 29613 31562208
Cytomegalovirus infection 35.43 11.01 19 105504 24688 31567133
Pneumococcal sepsis 35.21 11.01 28 105495 962 31590859
Drug resistance 35.18 11.01 17 105506 23436 31568385
Cerebrovascular accident 34.92 11.01 141 105382 79343 31512478
Diabetes mellitus 34.67 11.01 55 105468 42501 31549320
Blood pressure decreased 34.48 11.01 276 105247 47815 31544006
Coma blister 33.96 11.01 12 105511 68 31591753
Sedation 33.86 11.01 139 105384 18826 31572995
Breakthrough pain 33.70 11.01 22 105501 551 31591270
Hypoventilation 33.38 11.01 46 105477 3028 31588793
Unevaluable event 32.95 11.01 194 105329 30381 31561440
Neuropathy peripheral 32.73 11.01 135 105388 75514 31516307
Loss of personal independence in daily activities 32.23 11.01 28 105495 28260 31563561
Resuscitation 32.20 11.01 31 105492 1380 31590441
Chest discomfort 32.15 11.01 73 105450 49296 31542525
Application site rash 32.08 11.01 24 105499 752 31591069
Upper airway obstruction 32.00 11.01 22 105501 602 31591219
Injection site pain 31.93 11.01 41 105482 34593 31557228
Eosinophilia 31.74 11.01 19 105504 23234 31568587
Toxic leukoencephalopathy 31.61 11.01 17 105506 294 31591527
Accidental exposure to product 31.50 11.01 97 105426 11398 31580423
Brain death 31.19 11.01 40 105483 2455 31589366
Accidental poisoning 31.10 11.01 23 105500 708 31591113
Stoma closure 31.02 11.01 16 105507 253 31591568
Hyperhidrosis 30.97 11.01 352 105171 67041 31524780
Drug detoxification 30.96 11.01 15 105508 206 31591615
Blood pressure increased 30.90 11.01 148 105375 79485 31512336
Clonus 30.88 11.01 40 105483 2479 31589342
Diabetic ketoacidosis 30.79 11.01 9 105514 16896 31574925
Basal cell carcinoma 30.78 11.01 11 105512 18168 31573653
Gait disturbance 30.67 11.01 143 105380 77352 31514469
Therapeutic product effect increased 30.62 11.01 22 105501 647 31591174
Pulmonary congestion 30.56 11.01 104 105419 12879 31578942
Gastrointestinal haemorrhage 30.55 11.01 156 105367 82393 31509428
Influenza 30.13 11.01 64 105459 44261 31547560
Tachyphylaxis 30.13 11.01 13 105510 134 31591687
Oxygen saturation immeasurable 29.99 11.01 9 105514 27 31591794
Autonomic nervous system imbalance 29.97 11.01 39 105484 2428 31589393
Disorientation 29.93 11.01 190 105333 30554 31561267
Constipation 29.84 11.01 579 104944 123412 31468409
Pyrexia 29.57 11.01 778 104745 303062 31288759
Drug screen positive 29.52 11.01 49 105474 3803 31588018
Intestinal pseudo-obstruction 29.20 11.01 31 105492 1552 31590269
Cancer pain 29.16 11.01 39 105484 2494 31589327
Nephrolithiasis 28.86 11.01 29 105494 27310 31564511
Lymphadenectomy 28.73 11.01 17 105506 356 31591465
Rectal haemorrhage 28.56 11.01 48 105475 36256 31555565
Acute motor axonal neuropathy 28.55 11.01 10 105513 55 31591766
Seizure like phenomena 28.55 11.01 21 105502 641 31591180
Fall 28.43 11.01 442 105081 185647 31406174
Motor neurone disease 28.38 11.01 19 105504 497 31591324
Coma scale abnormal 28.05 11.01 47 105476 3676 31588145
Postoperative ileus 27.96 11.01 21 105502 662 31591159
International normalised ratio increased 27.75 11.01 69 105454 45154 31546667
Abdominal discomfort 27.67 11.01 84 105439 51483 31540338
Post procedural hypotension 27.55 11.01 10 105513 62 31591759
Drug withdrawal syndrome neonatal 27.54 11.01 45 105478 3447 31588374
Trigemino-cardiac reflex 27.40 11.01 13 105510 170 31591651
Recurrence of neuromuscular blockade 27.26 11.01 13 105510 172 31591649
Epistaxis 27.05 11.01 90 105433 53617 31538204
Urinary tract infection 26.92 11.01 148 105375 76721 31515100
Conversion disorder 26.91 11.01 16 105507 338 31591483
Product administered at inappropriate site 26.75 11.01 32 105491 1828 31589993
Haemoglobin decreased 26.69 11.01 243 105280 112432 31479389
Self-medication 26.20 11.01 35 105488 2236 31589585
Myocardial stunning 26.01 11.01 7 105516 12 31591809
Acute lung injury 25.96 11.01 27 105496 1320 31590501
Sinus tachycardia 25.84 11.01 113 105410 15736 31576085
Tooth loss 25.56 11.01 45 105478 3663 31588158
Herpes zoster 25.44 11.01 42 105481 31951 31559870
Hyperthermia 25.20 11.01 82 105441 9922 31581899
Atrial fibrillation 24.99 11.01 250 105273 113533 31478288
Transient ischaemic attack 24.85 11.01 26 105497 24030 31567791
Application site pruritus 24.78 11.01 26 105497 1284 31590537
Sputum increased 24.66 11.01 33 105490 2112 31589709
Metabolic acidosis 24.58 11.01 220 105303 39357 31552464
Pelvic pain 24.46 11.01 33 105490 2128 31589693
Hypopnoea 24.42 11.01 26 105497 1306 31590515
Thermophobia 24.37 11.01 9 105514 59 31591762
Product use in unapproved indication 24.31 11.01 212 105311 98959 31492862
Oedema peripheral 24.26 11.01 241 105282 109598 31482223
Electrocardiogram ST segment elevation 24.10 11.01 50 105473 4601 31587220
Methaemoglobinaemia 24.06 11.01 39 105484 2967 31588854
Oculocardiac reflex 23.99 11.01 9 105514 62 31591759
Bone marrow failure 23.96 11.01 35 105488 27973 31563848
Postmortem blood drug level increased 23.86 11.01 13 105510 231 31591590
Psoriatic arthropathy 23.49 11.01 19 105504 19864 31571957
Neutropenia 23.29 11.01 328 105195 140036 31451785
Type 2 diabetes mellitus 23.29 11.01 10 105513 14774 31577047
Diabetes insipidus 23.18 11.01 35 105488 2505 31589316
Amphetamines positive 23.04 11.01 11 105512 146 31591675
Suicide attempt 22.72 11.01 57 105466 37191 31554630
Palpitations 22.62 11.01 51 105472 34532 31557289
Lethargy 22.58 11.01 212 105311 38429 31553392
Lower respiratory tract infection bacterial 22.58 11.01 16 105507 460 31591361
Circulatory collapse 22.40 11.01 127 105396 19617 31572204
Musculoskeletal stiffness 22.39 11.01 67 105456 41258 31550563
Drug-induced liver injury 22.29 11.01 29 105494 24334 31567487
Anaemia 22.27 11.01 541 104982 212981 31378840
Acute respiratory distress syndrome 22.26 11.01 149 105374 24391 31567430
Sciatic nerve neuropathy 22.12 11.01 8 105515 49 31591772
Glycosylated haemoglobin increased 21.99 11.01 4 105519 10396 31581425
Acidosis 21.95 11.01 78 105445 9868 31581953
Pancreatitis acute 21.89 11.01 32 105491 25568 31566253
Visual acuity reduced 21.70 11.01 12 105511 15331 31576490
Anaesthetic complication pulmonary 21.70 11.01 6 105517 12 31591809
Application site hypersensitivity 21.62 11.01 10 105513 123 31591698
Influenza like illness 21.55 11.01 32 105491 25405 31566416
Disease complication 21.54 11.01 34 105489 2529 31589292
Melaena 21.49 11.01 48 105475 32606 31559215
Leukoencephalopathy 21.47 11.01 43 105480 3859 31587962
White blood cell count decreased 21.34 11.01 187 105336 87211 31504610
Endotracheal intubation 21.31 11.01 36 105487 2834 31588987
Platelet count decreased 21.30 11.01 250 105273 110185 31481636
Presyncope 21.18 11.01 16 105507 17312 31574509
Substance abuse 21.12 11.01 62 105461 7096 31584725
Arteriospasm coronary 21.12 11.01 36 105487 2855 31588966
Blood pressure fluctuation 20.87 11.01 27 105496 22709 31569112
Erectile dysfunction 20.77 11.01 20 105503 19215 31572606
Poor quality product administered 20.69 11.01 27 105496 1686 31590135
Bladder dilatation 20.62 11.01 24 105499 1332 31590489
Pneumonitis chemical 20.60 11.01 10 105513 138 31591683
Hyperlipidaemia 20.57 11.01 9 105514 13151 31578670
Device failure 20.44 11.01 30 105493 2093 31589728
Intercepted product dispensing error 20.30 11.01 8 105515 64 31591757
Application site dermatitis 20.21 11.01 7 105516 37 31591784
Paraplegia 20.16 11.01 34 105489 2673 31589148
Substance use 20.16 11.01 16 105507 548 31591273
Bronchitis 20.11 11.01 64 105459 38653 31553168
Full blood count abnormal 20.10 11.01 15 105508 16332 31575489
Mental status changes 19.86 11.01 195 105328 35773 31556048
Posthaemorrhagic hydrocephalus 19.80 11.01 9 105514 106 31591715
Systolic anterior motion of mitral valve 19.76 11.01 7 105516 40 31591781
Metastases to bone 19.75 11.01 80 105443 10768 31581053
Agranulocytosis 19.74 11.01 25 105498 21222 31570599
Ischaemic cerebral infarction 19.73 11.01 22 105501 1165 31590656
Hypotonic-hyporesponsive episode 19.52 11.01 6 105517 20 31591801
Dependence 19.44 11.01 21 105502 1073 31590748
Schizophrenia 19.30 11.01 6 105517 10824 31580997
Bronchial disorder 19.06 11.01 23 105500 1326 31590495
Postmortem blood drug level abnormal 19.02 11.01 12 105511 283 31591538
Hypercapnic coma 18.91 11.01 10 105513 167 31591654
Therapeutic product effect incomplete 18.88 11.01 78 105445 43618 31548203
Burkholderia test positive 18.83 11.01 20 105503 1002 31590819
Upper respiratory tract infection 18.75 11.01 44 105479 29378 31562443
Sinus arrest 18.66 11.01 24 105499 1477 31590344
Ventricular fibrillation 18.66 11.01 117 105406 18731 31573090
Photosensitivity reaction 18.54 11.01 5 105518 9899 31581922
Fluid retention 18.41 11.01 34 105489 24768 31567053
Acute myeloid leukaemia 18.38 11.01 21 105502 18651 31573170
Skin exfoliation 18.38 11.01 32 105491 23842 31567979
Multiple organ dysfunction syndrome 18.30 11.01 324 105199 67879 31523942
Application site irritation 18.28 11.01 16 105507 629 31591192
Pancytopenia 18.28 11.01 194 105329 87122 31504699
Pulse absent 18.25 11.01 49 105474 5328 31586493
Lower respiratory tract infection 18.18 11.01 42 105481 28195 31563626
Tuberculosis 18.10 11.01 3 105520 8338 31583483
Blood catecholamines increased 18.08 11.01 5 105518 10 31591811
Electrocardiogram T wave alternans 18.08 11.01 5 105518 10 31591811
Postoperative respiratory distress 18.08 11.01 5 105518 10 31591811
Hyperventilation 18.08 11.01 31 105492 2470 31589351
Ventricular tachycardia 18.07 11.01 138 105385 23563 31568258
Kounis syndrome 18.01 11.01 28 105495 2056 31589765
Abdominal compartment syndrome 17.98 11.01 18 105505 841 31590980
Product contamination 17.97 11.01 16 105507 644 31591177
Electrocardiogram ST segment depression 17.72 11.01 29 105494 2224 31589597
Acute myocardial infarction 17.70 11.01 98 105425 50725 31541096
Vomiting 17.65 11.01 913 104610 223060 31368761
Respiratory tract infection bacterial 17.54 11.01 23 105500 1443 31590378
Metabolic disorder 17.49 11.01 40 105483 3934 31587887
Product packaging issue 17.44 11.01 15 105508 576 31591245
Neonatal respiratory depression 17.41 11.01 13 105510 406 31591415
Cataract 17.35 11.01 33 105490 23774 31568047
Hypermagnesaemia 17.35 11.01 10 105513 199 31591622
Hypogonadism 17.24 11.01 26 105497 1859 31589962
Sweat gland disorder 17.11 11.01 8 105515 101 31591720
Cachexia 17.05 11.01 55 105468 6624 31585197
Ventricular arrhythmia 17.03 11.01 45 105478 4846 31586975
Injection site bruising 17.01 11.01 3 105520 7972 31583849
Chronic obstructive pulmonary disease 16.90 11.01 85 105438 45081 31546740
Drug screen negative 16.87 11.01 9 105514 153 31591668
Eye pain 16.87 11.01 10 105513 12294 31579527
Product packaging quantity issue 16.84 11.01 17 105506 802 31591019
Secretion discharge 16.76 11.01 45 105478 4892 31586929
Rash pruritic 16.74 11.01 34 105489 23904 31567917
Anal stenosis 16.72 11.01 9 105514 156 31591665
Eczema 16.68 11.01 16 105507 15401 31576420
Tendonitis 16.64 11.01 4 105519 8554 31583267
Pulmonary alveolar haemorrhage 16.63 11.01 55 105468 6711 31585110
Progressive multifocal leukoencephalopathy 16.61 11.01 5 105518 9208 31582613
Spinal cord compression 16.60 11.01 38 105485 3739 31588082
Myelodysplastic syndrome 16.52 11.01 24 105499 19227 31572594
Paraesthesia 16.48 11.01 114 105409 55957 31535864
Spinal cord infarction 16.42 11.01 11 105512 288 31591533
Non-cardiogenic pulmonary oedema 16.35 11.01 15 105508 628 31591193
Urinary retention 16.33 11.01 178 105345 33547 31558274
Erythema 16.28 11.01 180 105343 80225 31511596
Injection site haemorrhage 16.25 11.01 5 105518 9080 31582741
Gastrooesophageal reflux disease 16.21 11.01 58 105465 33813 31558008
Drug tolerance increased 16.19 11.01 13 105510 453 31591368
Acute kidney injury 16.13 11.01 764 104759 278950 31312871
Arthropathy 16.11 11.01 35 105488 24016 31567805
Dyskinesia 16.08 11.01 122 105401 20788 31571033
Motor dysfunction 16.00 11.01 52 105471 6287 31585534
Pneumonia aspiration 15.90 11.01 198 105325 38528 31553293
Hyponatraemia 15.84 11.01 163 105360 73636 31518185
Squamous cell carcinoma of skin 15.84 11.01 7 105516 10167 31581654
Prostate cancer metastatic 15.84 11.01 50 105473 5954 31585867
Product tampering 15.79 11.01 6 105517 43 31591778
Neuromuscular blockade 15.62 11.01 10 105513 242 31591579
Vision blurred 15.61 11.01 79 105444 41836 31549985
Injection site swelling 15.61 11.01 7 105516 10080 31581741
Myelosuppression 15.55 11.01 16 105507 14904 31576917
Therapy interrupted 15.41 11.01 8 105515 10588 31581233
Disease recurrence 15.31 11.01 24 105499 18637 31573184
Product communication issue 15.29 11.01 11 105512 324 31591497
Diabetes mellitus inadequate control 15.27 11.01 12 105511 12729 31579092
Asphyxia 15.27 11.01 48 105475 5703 31586118
Cerebral ischaemia 15.17 11.01 49 105474 5906 31585915
Air embolism 15.16 11.01 8 105515 133 31591688
Environmental exposure 15.09 11.01 10 105513 257 31591564
Urinary bladder rupture 15.07 11.01 7 105516 87 31591734
Trichoglossia 14.99 11.01 10 105513 260 31591561
Leukopenia 14.89 11.01 122 105401 57706 31534115
Application site erythema 14.88 11.01 26 105497 2103 31589718
Contusion 14.87 11.01 58 105465 32970 31558851
Chest pain 14.87 11.01 287 105236 116670 31475151
Viral infection 14.85 11.01 18 105505 15575 31576246
Condition aggravated 14.85 11.01 424 105099 163585 31428236
Vasoplegia syndrome 14.78 11.01 23 105500 1690 31590131
Asthenia 14.78 11.01 605 104918 224150 31367671
Scoliosis 14.73 11.01 29 105494 2570 31589251
Gynaecomastia 14.73 11.01 6 105517 9148 31582673
Completed suicide 14.72 11.01 404 105119 91110 31500711
Weight bearing difficulty 14.71 11.01 17 105506 936 31590885
Haematuria 14.70 11.01 92 105431 46222 31545599
Endotracheal intubation complication 14.64 11.01 11 105512 347 31591474
Haematotoxicity 14.55 11.01 3 105520 7134 31584687
Mechanical ventilation 14.53 11.01 24 105499 1855 31589966
Pulmonary haemorrhage 14.51 11.01 67 105456 9548 31582273
Wheezing 14.47 11.01 66 105457 35920 31555901
Rash maculo-papular 14.44 11.01 41 105482 25678 31566143
Dental caries 14.40 11.01 39 105484 4262 31587559
Preternatural anus 14.33 11.01 7 105516 98 31591723
Large intestine anastomosis 14.24 11.01 6 105517 58 31591763
Nasal congestion 14.21 11.01 29 105494 20352 31571469
Anaesthetic complication cardiac 14.20 11.01 5 105518 28 31591793
Laryngeal cancer metastatic 14.15 11.01 6 105517 59 31591762
Foetal megacystis 14.15 11.01 4 105519 9 31591812
Urinary ascites 14.15 11.01 4 105519 9 31591812
Meningococcal bacteraemia 14.15 11.01 4 105519 9 31591812
Localised infection 14.14 11.01 18 105505 15247 31576574
Hippocampal atrophy 14.13 11.01 3 105520 0 31591821
Angina unstable 14.12 11.01 10 105513 11185 31580636
Sleep disorder 14.07 11.01 43 105480 26305 31565516
Substance dependence 14.03 11.01 11 105512 370 31591451
Dry skin 14.03 11.01 41 105482 25440 31566381
Ear infection 14.00 11.01 6 105517 8875 31582946
Atrial septal defect 13.94 11.01 3 105520 6924 31584897
Oesophageal mucosa erythema 13.91 11.01 5 105518 30 31591791
Migraine 13.90 11.01 16 105507 14164 31577657
Mechanical ventilation complication 13.86 11.01 4 105519 10 31591811
Performance status decreased 13.83 11.01 36 105487 3842 31587979
PCO2 increased 13.78 11.01 13 105510 564 31591257
Hepatic enzyme increased 13.76 11.01 67 105456 35841 31555980
Drug intolerance 13.75 11.01 109 105414 51924 31539897
Cytopenia 13.67 11.01 10 105513 11000 31580821
Pathological fracture 13.65 11.01 37 105486 4045 31587776
Aspergillus infection 13.64 11.01 11 105512 11517 31580304
Multiple sclerosis relapse 13.63 11.01 12 105511 12035 31579786
Capillary nail refill test abnormal 13.51 11.01 5 105518 33 31591788
Tumour pain 13.50 11.01 17 105506 1024 31590797
Catecholamine crisis 13.39 11.01 5 105518 34 31591787
Local anaesthetic systemic toxicity 13.36 11.01 9 105514 238 31591583
Neuroendocrine tumour of the lung metastatic 13.34 11.01 7 105516 115 31591706
Hypophonesis 13.33 11.01 4 105519 12 31591809
Unwanted awareness during anaesthesia 13.26 11.01 5 105518 35 31591786
Exposure during pregnancy 13.25 11.01 6 105517 8592 31583229
Therapeutic product effect prolonged 13.20 11.01 9 105514 243 31591578
Orthostatic hypotension 13.14 11.01 39 105484 24080 31567741
Oropharyngeal pain 13.10 11.01 57 105466 31426 31560395
Cardiac failure chronic 13.10 11.01 4 105519 7299 31584522
Gastrointestinal disorder 13.07 11.01 55 105468 30605 31561216
Pancreatic carcinoma 13.03 11.01 60 105463 8540 31583281
Locked-in syndrome 12.82 11.01 9 105514 255 31591566
Mucosal atrophy 12.81 11.01 6 105517 76 31591745
Medical device site fistula 12.80 11.01 5 105518 39 31591782
Atelectasis 12.75 11.01 95 105428 16094 31575727
Paralysis recurrent laryngeal nerve 12.69 11.01 5 105518 40 31591781
Hypoperfusion 12.67 11.01 17 105506 1091 31590730
Trismus 12.63 11.01 26 105497 2379 31589442
Haematochezia 12.52 11.01 81 105442 40383 31551438
Application site vesicles 12.45 11.01 12 105511 535 31591286
Dyslipidaemia 12.44 11.01 3 105520 6403 31585418
Injection site erythema 12.44 11.01 18 105505 14444 31577377
Toxicologic test abnormal 12.41 11.01 12 105511 537 31591284
Social anxiety disorder 12.37 11.01 9 105514 270 31591551
Eastern Cooperative Oncology Group performance status worsened 12.35 11.01 15 105508 871 31590950
Product administration error 12.31 11.01 90 105433 15157 31576664
Chronic kidney disease 12.27 11.01 75 105448 37900 31553921
Oedema 12.27 11.01 87 105436 42474 31549347
Epilepsy 12.22 11.01 33 105490 21008 31570813
Tracheal pain 12.18 11.01 5 105518 45 31591776
Pupil fixed 12.13 11.01 21 105502 1686 31590135
Postmortem blood drug level 12.11 11.01 7 105516 140 31591681
Anion gap abnormal 12.11 11.01 7 105516 140 31591681
Atonic urinary bladder 12.08 11.01 4 105519 18 31591803
Torsade de pointes 12.06 11.01 50 105473 6800 31585021
Mitochondrial encephalomyopathy 12.06 11.01 3 105520 3 31591818
Glossopharyngeal nerve paralysis 12.06 11.01 3 105520 3 31591818
Rash erythematous 12.03 11.01 37 105486 22590 31569231
Pathogen resistance 12.03 11.01 7 105516 8694 31583127
Areflexia 12.01 11.01 28 105495 2788 31589033
Diaphragmatic rupture 11.90 11.01 4 105519 19 31591802
Mobility decreased 11.88 11.01 49 105474 27420 31564401
Mean arterial pressure decreased 11.85 11.01 7 105516 146 31591675
Application site pain 11.76 11.01 21 105502 1728 31590093
Clinical trial participant 11.74 11.01 6 105517 93 31591728
Intentional overdose 11.74 11.01 85 105438 41304 31550517
Thrombosis 11.74 11.01 95 105428 45056 31546765
Claustrophobia 11.73 11.01 8 105515 216 31591605
Lymphadenopathy 11.67 11.01 46 105477 26075 31565746
Gastritis 11.65 11.01 32 105491 20260 31571561
Complication of device removal 11.63 11.01 5 105518 51 31591770
Pseudopolyp 11.63 11.01 8 105515 219 31591602
Muscle atrophy 11.63 11.01 50 105473 6911 31584910
Visual impairment 11.62 11.01 59 105464 31220 31560601
Tubulointerstitial nephritis 11.52 11.01 28 105495 18468 31573353
Productive cough 11.50 11.01 65 105458 33475 31558346
Aspiration 11.45 11.01 68 105455 10678 31581143
Impaired driving ability 11.36 11.01 25 105498 2396 31589425
Intestinal ischaemia 11.31 11.01 50 105473 6995 31584826
Airway peak pressure increased 11.27 11.01 4 105519 23 31591798
Blood triglycerides increased 11.21 11.01 17 105506 13380 31578441
Appendicitis 11.17 11.01 13 105510 11452 31580369
Hyperreflexia 11.16 11.01 28 105495 2921 31588900
Salivary hypersecretion 11.16 11.01 6 105517 7786 31584035
Laryngomalacia 11.15 11.01 9 105514 316 31591505
Phaeochromocytoma crisis 11.14 11.01 5 105518 57 31591764
Malignant catatonia 11.11 11.01 8 105515 236 31591585
Knee arthroplasty 11.05 11.01 4 105519 6554 31585267
Infection 11.04 11.01 199 105324 81732 31510089

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 10075.16 9.84 5840 194650 141416 70586538
Toxicity to various agents 2559.95 9.84 4165 196325 378007 70349947
Respiratory arrest 1278.36 9.84 1125 199365 52808 70675146
Cardio-respiratory arrest 1119.80 9.84 1401 199089 99276 70628678
Cardiac arrest 1114.09 9.84 1778 198712 158056 70569898
Serotonin syndrome 1049.31 9.84 904 199586 41210 70686744
Respiratory depression 905.90 9.84 667 199823 24164 70703790
Incorrect route of product administration 884.96 9.84 675 199815 25817 70702137
Overdose 778.70 9.84 1574 198916 168171 70559783
Drug withdrawal syndrome 605.78 9.84 595 199895 32120 70695834
Intentional product misuse 572.45 9.84 899 199591 78696 70649258
Death 493.57 9.84 2783 197707 507278 70220676
Anaphylactic reaction 487.52 9.84 809 199681 74165 70653789
Product adhesion issue 440.81 9.84 190 200300 2334 70725620
Unresponsive to stimuli 432.19 9.84 628 199862 51303 70676651
Inadequate analgesia 411.90 9.84 211 200279 3911 70724043
Rheumatoid arthritis 406.84 9.84 158 200332 291647 70436307
Miosis 390.78 9.84 322 200168 13779 70714175
Drug dependence 377.65 9.84 496 199994 36825 70691129
Accidental exposure to product by child 349.87 9.84 167 200323 2639 70725315
Drug interaction 336.86 9.84 2033 198457 379408 70348546
Hyperthermia malignant 336.76 9.84 160 200330 2501 70725453
Apnoea 323.12 9.84 258 200232 10551 70717403
Synovitis 316.07 9.84 11 200479 129217 70598737
Depressed level of consciousness 301.90 9.84 724 199766 86707 70641247
Delayed recovery from anaesthesia 281.11 9.84 120 200370 1437 70726517
Somnolence 278.93 9.84 1278 199212 214328 70513626
Hypotension 273.45 9.84 2017 198473 402364 70325590
Anaesthetic complication 269.39 9.84 137 200353 2499 70725455
Delirium 268.57 9.84 628 199862 73986 70653968
Hyperaesthesia 262.50 9.84 230 200260 10712 70717242
Accidental overdose 259.73 9.84 402 200088 34719 70693235
Joint swelling 253.83 9.84 206 200284 253005 70474949
Arthralgia 248.19 9.84 672 199818 502718 70225236
Pulmonary oedema 238.81 9.84 638 199852 81640 70646314
Infusion related reaction 235.00 9.84 133 200357 197401 70530553
Systemic lupus erythematosus 228.90 9.84 15 200475 101887 70626067
Headache 228.63 9.84 857 199633 579548 70148406
Alopecia 225.77 9.84 141 200349 198349 70529605
Hand deformity 224.15 9.84 4 200486 86478 70641476
Nasopharyngitis 219.92 9.84 183 200307 222023 70505931
Bradycardia 218.94 9.84 812 199678 123803 70604151
Arthropathy 206.05 9.84 83 200407 149974 70577980
Product quality issue 197.48 9.84 329 200161 30232 70697722
Myoclonus 196.73 9.84 303 200187 26052 70701902
Product prescribing error 196.07 9.84 376 200114 38576 70689378
Rash 193.77 9.84 765 199725 509797 70218157
Cough 193.27 9.84 393 200097 324984 70402970
Sinusitis 192.66 9.84 120 200370 169075 70558879
Glossodynia 190.56 9.84 14 200476 86473 70641481
Maternal exposure during delivery 186.48 9.84 79 200411 927 70727027
Neuromuscular block prolonged 181.58 9.84 77 200413 906 70727048
Respiratory acidosis 179.19 9.84 181 200309 10100 70717854
Withdrawal syndrome 178.48 9.84 281 200209 24623 70703331
Product complaint 176.97 9.84 195 200295 12036 70715918
Fatigue 174.73 9.84 1492 198998 822827 69905127
Malignant neoplasm progression 173.42 9.84 743 199747 120996 70606958
Abdominal discomfort 169.08 9.84 215 200275 214443 70513511
Bradypnoea 166.80 9.84 132 200358 5327 70722627
Pericarditis 162.67 9.84 23 200467 84682 70643272
Peripheral swelling 154.22 9.84 270 200220 236293 70491661
Fear 152.16 9.84 237 200253 20574 70707380
Drug intolerance 150.40 9.84 254 200236 225433 70502521
Hypoxia 149.72 9.84 591 199899 92753 70635201
Respiratory rate decreased 149.06 9.84 117 200373 4665 70723289
Weight increased 147.85 9.84 288 200202 242043 70485911
Procedural hypotension 146.98 9.84 83 200407 1883 70726071
Anaphylactic shock 145.89 9.84 299 200191 32191 70695763
Contraindicated product administered 145.73 9.84 101 200389 134511 70593443
Pulseless electrical activity 143.62 9.84 182 200308 13033 70714921
Pruritus 141.85 9.84 501 199989 345059 70382895
Helicobacter infection 138.69 9.84 4 200486 55652 70672302
Agitation 137.69 9.84 576 199914 92799 70635155
Amnestic disorder 137.61 9.84 55 200435 550 70727404
Swelling 137.20 9.84 200 200290 188339 70539615
Post procedural complication 136.40 9.84 233 200257 21848 70706106
Drug use disorder 135.69 9.84 140 200350 8011 70719943
Treatment failure 134.94 9.84 125 200365 144017 70583937
Product dose omission issue 133.91 9.84 257 200233 217211 70510743
Brain oedema 127.74 9.84 234 200256 23184 70704770
Hepatic enzyme increased 124.88 9.84 156 200334 156834 70571120
Injection site pain 123.71 9.84 91 200399 117528 70610426
Coma 122.73 9.84 550 199940 91294 70636660
Tachycardia 122.10 9.84 817 199673 157729 70570225
Renal injury 120.06 9.84 185 200305 15909 70712045
Bronchospasm 119.63 9.84 224 200266 22568 70705386
Lower respiratory tract infection 117.16 9.84 87 200403 111826 70616128
Duodenal ulcer perforation 116.33 9.84 7 200483 51105 70676849
Drug abuser 114.78 9.84 110 200380 5754 70722200
Muscle rigidity 114.15 9.84 196 200294 18454 70709500
Poisoning 112.15 9.84 217 200273 22405 70705549
Oxygen saturation decreased 109.72 9.84 632 199858 115797 70612157
Respiratory failure 109.32 9.84 834 199656 167901 70560053
Off label use 108.61 9.84 1465 199025 741595 69986359
Opiates positive 108.30 9.84 53 200437 887 70727067
Hypoventilation 107.67 9.84 112 200378 6470 70721484
Anhedonia 106.90 9.84 164 200326 14049 70713905
Blood pressure decreased 106.88 9.84 527 199963 90988 70636966
Stress cardiomyopathy 105.87 9.84 135 200355 9727 70718227
Asthma 103.62 9.84 113 200377 120680 70607274
Neoplasm progression 103.38 9.84 322 200168 44906 70683048
Procedural complication 100.51 9.84 115 200375 7399 70720555
Diarrhoea 98.99 9.84 1589 198901 781752 69946202
Presbyacusis 98.76 9.84 72 200418 2565 70725389
Folliculitis 96.37 9.84 6 200484 42564 70685390
Drug diversion 95.84 9.84 53 200437 1153 70726801
Emotional distress 95.62 9.84 276 200214 36912 70691042
Product counterfeit 95.34 9.84 33 200457 211 70727743
Circulatory collapse 93.85 9.84 266 200224 35208 70692746
Haemodynamic instability 92.49 9.84 162 200328 15496 70712458
Deafness neurosensory 91.25 9.84 103 200387 6529 70721425
Myalgia 91.10 9.84 213 200277 167679 70560275
Hypersensitivity 91.02 9.84 338 200152 229474 70498480
Irritable bowel syndrome 90.48 9.84 17 200473 50833 70677121
Completed suicide 89.97 9.84 1010 199480 226125 70501829
Toxic leukoencephalopathy 87.95 9.84 47 200443 953 70727001
Medication error 87.75 9.84 356 200134 56556 70671398
Brain injury 87.70 9.84 128 200362 10489 70717465
Therapeutic product effect incomplete 86.36 9.84 128 200362 119754 70608200
Laryngospasm 86.22 9.84 76 200414 3567 70724387
Prescription drug used without a prescription 84.20 9.84 69 200421 2928 70725026
Wound 83.97 9.84 93 200397 98639 70629315
Ventricular tachycardia 82.95 9.84 259 200231 36164 70691790
Hypercapnia 80.08 9.84 108 200382 8221 70719733
Pain in extremity 79.78 9.84 571 199919 327511 70400443
Confusional state 79.07 9.84 1185 199305 283213 70444741
Pleural fibrosis 77.92 9.84 76 200414 4063 70723891
Psoriasis 77.01 9.84 99 200391 98334 70629620
Therapy naive 76.29 9.84 21 200469 52 70727902
Propofol infusion syndrome 75.85 9.84 52 200438 1677 70726277
Faecaloma 74.98 9.84 118 200372 10333 70717621
Constipation 74.16 9.84 1062 199428 251376 70476578
Cyanosis 73.49 9.84 186 200304 23020 70704934
Influenza 72.91 9.84 131 200359 113569 70614385
Urinary retention 72.77 9.84 318 200172 52202 70675752
Anaesthetic complication neurological 71.01 9.84 34 200456 541 70727413
Sedation 70.99 9.84 291 200199 46440 70681514
Ill-defined disorder 70.78 9.84 33 200457 54708 70673246
Blood cholesterol increased 70.52 9.84 48 200442 64556 70663398
Musculoskeletal stiffness 70.51 9.84 200 200290 147560 70580394
Blood magnesium increased 70.01 9.84 65 200425 3266 70724688
Drug screen positive 69.19 9.84 84 200406 5756 70722198
Hypoxic-ischaemic encephalopathy 69.10 9.84 94 200396 7214 70720740
Myoglobin urine present 68.86 9.84 36 200454 697 70727257
Labile blood pressure 68.26 9.84 53 200437 2079 70725875
Cardiac failure congestive 67.89 9.84 179 200311 135278 70592676
Wrong technique in product usage process 67.38 9.84 377 200113 68321 70659633
Injection site erythema 67.33 9.84 64 200426 72860 70655094
Dizziness 67.27 9.84 916 199574 463225 70264729
Pleural thickening 66.86 9.84 59 200431 2773 70725181
Dyspnoea exertional 66.55 9.84 74 200416 78356 70649598
Clonus 66.02 9.84 85 200405 6183 70721771
Intensive care unit acquired weakness 65.52 9.84 48 200442 1723 70726231
Counterfeit product administered 65.47 9.84 21 200469 102 70727852
Discomfort 65.37 9.84 124 200366 105312 70622642
Airway complication of anaesthesia 65.27 9.84 29 200461 385 70727569
Narcotic bowel syndrome 64.38 9.84 25 200465 230 70727724
C-reactive protein abnormal 64.32 9.84 15 200475 38564 70689390
Breakthrough pain 64.30 9.84 42 200448 1248 70726706
Psoriatic arthropathy 63.19 9.84 54 200436 64717 70663237
Multiple organ dysfunction syndrome 62.92 9.84 523 199967 107992 70619962
Tachypnoea 62.79 9.84 201 200289 28437 70699517
Red blood cell sedimentation rate increased 62.52 9.84 16 200474 38626 70689328
Drug ineffective 62.42 9.84 2105 198385 937647 69790307
Disorientation 62.31 9.84 326 200164 57597 70670357
Intercepted product dispensing error 62.22 9.84 21 200469 123 70727831
Intestinal pseudo-obstruction 62.04 9.84 52 200438 2278 70725676
Mental status changes 61.70 9.84 346 200144 62755 70665199
Condition aggravated 61.22 9.84 846 199644 426789 70301165
Knee arthroplasty 59.90 9.84 12 200478 34289 70693665
Kounis syndrome 59.34 9.84 60 200430 3351 70724603
COVID-19 58.29 9.84 133 200357 105624 70622330
Type 2 diabetes mellitus 57.88 9.84 26 200464 44054 70683900
Hip arthroplasty 57.79 9.84 6 200484 28034 70699920
Accidental death 57.74 9.84 63 200427 3845 70724109
Malaise 57.58 9.84 869 199621 432063 70295891
Herpes zoster 56.65 9.84 96 200394 85139 70642815
Infusion site coldness 56.41 9.84 22 200468 205 70727749
Arthritis 55.82 9.84 121 200369 97859 70630095
Tryptase increased 55.44 9.84 29 200461 562 70727392
Hyperhidrosis 55.20 9.84 592 199898 130994 70596960
Bronchitis 54.97 9.84 160 200330 117083 70610871
Application site pruritus 54.86 9.84 59 200431 3542 70724412
Therapeutic product effect prolonged 54.50 9.84 28 200462 522 70727432
Basal cell carcinoma 54.42 9.84 14 200476 33684 70694270
Pulse absent 54.42 9.84 96 200394 9234 70718720
Cancer pain 54.35 9.84 68 200422 4806 70723148
Metastases to bone 53.64 9.84 162 200328 22214 70705740
Amphetamines positive 53.27 9.84 22 200468 241 70727713
Coma scale abnormal 53.26 9.84 88 200402 8028 70719926
Injection site reaction 53.14 9.84 38 200452 49814 70678140
Injury 52.46 9.84 340 200150 64905 70663049
Application site erythema 52.41 9.84 66 200424 4695 70723259
Loss of consciousness 52.21 9.84 671 199819 155045 70572909
Blood potassium increased 52.12 9.84 183 200307 27143 70700811
Therapeutic product effect increased 52.11 9.84 38 200452 1354 70726600
Chest discomfort 51.82 9.84 179 200311 124202 70603752
Spinal muscular atrophy 51.37 9.84 25 200465 413 70727541
Accidental exposure to product 51.06 9.84 185 200305 27866 70700088
Mobility decreased 50.93 9.84 137 200353 102862 70625092
Oropharyngeal pain 50.78 9.84 124 200366 96186 70631768
Device expulsion 50.76 9.84 3 200487 22243 70705711
Neuromuscular blockade 50.72 9.84 27 200463 543 70727411
Palpitations 50.58 9.84 153 200337 110600 70617354
Gastrooesophageal reflux disease 50.26 9.84 114 200376 90725 70637229
Ventricular fibrillation 49.52 9.84 179 200311 26932 70701022
Recurrence of neuromuscular blockade 49.30 9.84 21 200469 250 70727704
Unevaluable event 49.26 9.84 283 200207 51780 70676174
Loss of personal independence in daily activities 49.08 9.84 104 200386 84806 70643148
Nasal congestion 48.38 9.84 69 200421 65603 70662351
Anion gap 48.28 9.84 41 200449 1829 70726125
Dyspnoea 47.78 9.84 1739 198751 768321 69959633
Increased bronchial secretion 47.69 9.84 51 200439 3042 70724912
Application site reaction 47.33 9.84 28 200462 695 70727259
Epigastric discomfort 46.89 9.84 78 200412 7155 70720799
Abortion spontaneous 46.79 9.84 9 200481 26470 70701484
Pulmonary congestion 46.72 9.84 167 200323 24987 70702967
Blister 46.53 9.84 138 200352 100388 70627566
Product use issue 46.23 9.84 308 200182 179629 70548325
Abdominal pain upper 46.01 9.84 339 200151 193263 70534691
Gamma-glutamyltransferase decreased 46.01 9.84 22 200468 349 70727605
Endotracheal intubation complication 45.87 9.84 28 200462 737 70727217
Injection site pruritus 45.72 9.84 27 200463 39183 70688771
Upper airway obstruction 45.42 9.84 34 200456 1262 70726692
Allodynia 45.41 9.84 35 200455 1358 70726596
Fibromyalgia 45.39 9.84 41 200449 47833 70680121
Transient ischaemic attack 45.19 9.84 38 200452 45906 70682048
Cerebrovascular accident 44.61 9.84 231 200259 143239 70584715
Anterior spinal artery syndrome 44.42 9.84 15 200475 88 70727866
Drug tolerance 44.06 9.84 77 200413 7351 70720603
Hypermobility syndrome 43.99 9.84 24 200466 508 70727446
Renal failure 43.95 9.84 765 199725 188305 70539649
Application site rash 43.77 9.84 40 200450 1969 70725985
Diabetes mellitus 43.19 9.84 86 200404 71738 70656216
Electrocardiogram ST segment elevation 42.76 9.84 77 200413 7527 70720427
Vomiting 42.69 9.84 2067 198423 591044 70136910
Lethargy 42.19 9.84 360 200130 74890 70653064
Injection site swelling 42.07 9.84 36 200454 43121 70684833
Encephalopathy 41.70 9.84 308 200182 61353 70666601
Ear infection 41.69 9.84 14 200476 28322 70699632
Stomatitis 41.61 9.84 204 200286 128307 70599647
Methaemoglobinaemia 41.43 9.84 59 200431 4727 70723227
Anaesthetic complication pulmonary 41.07 9.84 13 200477 60 70727894
Anterograde amnesia 40.99 9.84 25 200465 657 70727297
Metabolic acidosis 40.80 9.84 354 200136 73992 70653962
Restlessness 40.52 9.84 230 200260 41898 70686056
Resuscitation 40.46 9.84 41 200449 2296 70725658
Tumour pain 40.39 9.84 39 200451 2059 70725895
Local anaesthetic systemic toxicity 40.29 9.84 27 200463 838 70727116
Acute respiratory distress syndrome 40.18 9.84 226 200264 41028 70686926
General physical health deterioration 40.09 9.84 911 199579 235120 70492834
Compartment syndrome 39.86 9.84 56 200434 4430 70723524
Osteoporosis 39.49 9.84 48 200442 48859 70679095
Infection 39.38 9.84 393 200097 210392 70517562
Carcinoid crisis 39.36 9.84 22 200468 489 70727465
Sinus tachycardia 39.36 9.84 195 200295 33718 70694236
Negative pressure pulmonary oedema 39.35 9.84 17 200473 210 70727744
Acute lung injury 39.28 9.84 44 200446 2765 70725189
Diabetic ketoacidosis 39.21 9.84 20 200470 31492 70696462
Osteopenia 39.19 9.84 120 200370 16577 70711377
Cytomegalovirus infection 38.96 9.84 33 200457 39725 70688229
Contusion 38.77 9.84 208 200282 127828 70600126
Upper respiratory tract infection 38.77 9.84 106 200384 79168 70648786
Hypopnoea 38.65 9.84 48 200442 3367 70724587
Airway peak pressure increased 38.35 9.84 19 200471 327 70727627
Procedural hypertension 37.90 9.84 18 200472 281 70727673
Brain death 37.89 9.84 59 200431 5119 70722835
Exposure to toxic agent 37.78 9.84 65 200425 6129 70721825
Cachexia 37.43 9.84 85 200405 9815 70718139
Gastrointestinal disorder 37.31 9.84 162 200328 105265 70622689
Unwanted awareness during anaesthesia 37.28 9.84 18 200472 292 70727662
Gait disturbance 36.75 9.84 340 200150 184766 70543188
Wheezing 36.27 9.84 140 200350 94030 70633924
Post procedural hypotension 35.89 9.84 12 200478 68 70727886
Application site dermatitis 35.87 9.84 15 200475 170 70727784
Horner's syndrome 35.71 9.84 10 200480 27 70727927
Substance abuse 35.58 9.84 83 200407 9754 70718200
Bradycardia foetal 35.28 9.84 13 200477 102 70727852
Progressive multifocal leukoencephalopathy 35.10 9.84 6 200484 19208 70708746
Leukoencephalopathy 34.97 9.84 69 200421 7225 70720729
Hallucination 34.28 9.84 348 200142 75912 70652042
Oxygen saturation immeasurable 34.22 9.84 10 200480 33 70727921
Blood glucose increased 34.20 9.84 162 200328 102820 70625134
Rash pruritic 34.07 9.84 80 200410 62911 70665043
Cataract 33.99 9.84 66 200424 55579 70672375
Drug-induced liver injury 33.89 9.84 67 200423 56046 70671908
Fluid retention 33.89 9.84 81 200409 63304 70664650
Pneumonia aspiration 33.87 9.84 296 200194 61993 70665961
Rhinorrhoea 33.78 9.84 87 200403 66284 70661670
Premature delivery 33.41 9.84 134 200356 21170 70706784
Orthostatic hypotension 32.82 9.84 60 200430 51683 70676271
Generalised tonic-clonic seizure 32.82 9.84 216 200274 41445 70686509
Vasodilatation 32.72 9.84 42 200448 3046 70724908
Stoma closure 32.63 9.84 16 200474 269 70727685
Osteosclerosis 32.55 9.84 46 200444 3659 70724295
Insomnia 32.51 9.84 427 200063 217379 70510575
Femoral hernia incarcerated 32.43 9.84 23 200467 784 70727170
Paraplegia 32.00 9.84 52 200438 4678 70723276
Normal newborn 31.92 9.84 61 200429 6239 70721715
Bone cyst 31.89 9.84 40 200450 2834 70725120
Altered state of consciousness 31.83 9.84 208 200282 39814 70688140
Nephrolithiasis 31.72 9.84 53 200437 47270 70680684
Hepatic ischaemia 31.48 9.84 25 200465 1014 70726940
Arteriospasm coronary 31.35 9.84 59 200431 5965 70721989
Drug resistance 31.35 9.84 37 200453 38153 70689801
Trigemino-cardiac reflex 31.20 9.84 15 200475 241 70727713
Joint stiffness 31.16 9.84 32 200458 35144 70692810
Blood pressure increased 30.98 9.84 362 200128 188155 70539799
Postmortem blood drug level increased 30.74 9.84 22 200468 761 70727193
Dyskinesia 30.58 9.84 210 200280 40864 70687090
Plasma cell myeloma 30.53 9.84 329 200161 72872 70655082
Visual impairment 30.46 9.84 120 200370 80130 70647824
Lymphatic fistula 30.31 9.84 22 200468 778 70727176
Poor quality product administered 30.22 9.84 42 200448 3289 70724665
Left ventricle outflow tract obstruction 29.87 9.84 16 200474 326 70727628
Productive cough 29.82 9.84 117 200373 78220 70649734
Substance use 29.79 9.84 21 200469 709 70727245
Pregnancy 29.73 9.84 15 200475 23766 70704188
Blood pressure measurement 29.63 9.84 17 200473 398 70727556
Cauda equina syndrome 29.57 9.84 26 200464 1216 70726738
Pneumococcal sepsis 29.48 9.84 28 200462 1448 70726506
Hyperreflexia 29.37 9.84 65 200425 7377 70720577
Systolic anterior motion of mitral valve 29.29 9.84 10 200480 61 70727893
Arachnoid web 29.27 9.84 7 200483 7 70727947
Postoperative delirium 29.23 9.84 14 200476 223 70727731
Oedema peripheral 29.18 9.84 461 200029 227630 70500324
Application site irritation 29.15 9.84 29 200461 1588 70726366
Angina pectoris 29.03 9.84 58 200432 48325 70679629
Multiple sclerosis relapse 28.99 9.84 48 200442 42969 70684985
Self-medication 28.92 9.84 48 200442 4395 70723559
Motor neurone disease 28.81 9.84 19 200471 574 70727380
Anaesthetic complication cardiac 28.75 9.84 10 200480 65 70727889
Spinal cord infarction 28.75 9.84 19 200471 576 70727378
Acidosis 28.74 9.84 115 200375 18148 70709806
Myelosuppression 28.36 9.84 26 200464 30119 70697835
Infusion site induration 28.33 9.84 22 200468 863 70727091
Pupil fixed 28.33 9.84 41 200449 3333 70724621
Product administered at inappropriate site 28.32 9.84 41 200449 3335 70724619
Application site vesicles 27.99 9.84 26 200464 1307 70726647
Injection site bruising 27.97 9.84 40 200450 37992 70689962
Hyperthermia 27.88 9.84 107 200383 16564 70711390
Phrenic nerve paralysis 27.81 9.84 15 200475 310 70727644
Exposure during pregnancy 27.72 9.84 374 200116 87343 70640611
Atrioventricular block second degree 27.66 9.84 60 200430 6718 70721236
Eczema 27.44 9.84 33 200457 33748 70694206
Seroma 27.43 9.84 32 200458 2102 70725852
Liver disorder 27.43 9.84 86 200404 61482 70666472
Acute postoperative sialadenitis 27.37 9.84 9 200481 48 70727906
Myocardial infarction 27.28 9.84 332 200158 171313 70556641
Non-cardiogenic pulmonary oedema 27.27 9.84 26 200464 1351 70726603
Diabetes insipidus 27.16 9.84 48 200442 4623 70723331
Dependence 27.11 9.84 33 200457 2267 70725687
Anorectal ulcer 27.06 9.84 9 200481 50 70727904
Non-consummation 27.06 9.84 9 200481 50 70727904
Sinus arrest 26.90 9.84 39 200451 3176 70724778
Pancreatic steatosis 26.87 9.84 23 200467 1037 70726917
Neurotoxicity 26.83 9.84 160 200330 29666 70698288
Mental status changes postoperative 26.83 9.84 12 200478 162 70727792
Muscle relaxant therapy 26.63 9.84 12 200478 165 70727789
Opisthotonus 26.40 9.84 19 200471 663 70727291
Postmortem blood drug level 26.37 9.84 14 200476 280 70727674
Tuberculosis 26.34 9.84 5 200485 14843 70713111
Joint range of motion decreased 26.25 9.84 21 200469 26005 70701949
Therapeutic product effect decreased 26.14 9.84 268 200222 142750 70585204
Inflammation 25.97 9.84 124 200366 78541 70649413
Eye pain 25.95 9.84 35 200455 34067 70693887
Mean arterial pressure decreased 25.92 9.84 15 200475 357 70727597
Blood pressure diastolic abnormal 25.90 9.84 6 200484 15498 70712456
Musculoskeletal disorder 25.87 9.84 12 200478 19959 70707995
Thermophobia 25.81 9.84 9 200481 59 70727895
Autonomic nervous system imbalance 25.76 9.84 45 200445 4294 70723660
Pulmonary arterial hypertension 25.73 9.84 33 200457 32822 70695132
Viral infection 25.72 9.84 43 200447 38348 70689606
Toxic encephalopathy 25.56 9.84 76 200414 10330 70717624
Swelling face 25.56 9.84 92 200398 63072 70664882
C-reactive protein increased 25.53 9.84 195 200295 110322 70617632
Conversion disorder 25.51 9.84 28 200462 1720 70726234
Oculocardiac reflex 25.43 9.84 9 200481 62 70727892
Product packaging quantity issue 25.39 9.84 23 200467 1119 70726835
Localised infection 25.26 9.84 34 200456 33124 70694830
Spinal anaesthesia 24.95 9.84 9 200481 66 70727888
Acute motor axonal neuropathy 24.84 9.84 10 200480 102 70727852
Anticholinergic syndrome 24.72 9.84 36 200454 2944 70725010
Vasoplegia syndrome 24.56 9.84 37 200453 3119 70724835
Dehydration 24.54 9.84 824 199666 225318 70502636
Confusion postoperative 24.51 9.84 12 200478 201 70727753
Performance status decreased 24.49 9.84 51 200439 5550 70722404
Eosinophilia 24.47 9.84 48 200442 40271 70687683
Hypercapnic coma 24.37 9.84 15 200475 401 70727553
Neuropathy peripheral 24.35 9.84 235 200255 126661 70601293
Cystitis 24.30 9.84 61 200429 46880 70681074
Epistaxis 24.22 9.84 180 200310 102447 70625507
Wound infection pseudomonas 24.21 9.84 26 200464 1558 70726396
Dystonia 24.08 9.84 115 200375 19591 70708363
Air embolism 23.94 9.84 15 200475 414 70727540
Systemic infection 23.89 9.84 56 200434 6601 70721353
Vascular resistance systemic decreased 23.89 9.84 12 200478 213 70727741
Sneezing 23.87 9.84 9 200481 16942 70711012
Tracheal deviation 23.86 9.84 11 200479 160 70727794
Product contamination 23.77 9.84 22 200468 1101 70726853
Anaphylactoid reaction 23.57 9.84 47 200443 4960 70722994
Apnoeic attack 23.53 9.84 17 200473 597 70727357
Postoperative ileus 23.37 9.84 21 200469 1011 70726943
Prostate cancer metastatic 23.36 9.84 41 200449 3928 70724026
Potentiating drug interaction 23.35 9.84 63 200427 8101 70719853
Coma blister 23.34 9.84 12 200478 224 70727730
Supraventricular tachycardia 23.34 9.84 114 200376 19596 70708358
Drug tolerance increased 23.26 9.84 17 200473 608 70727346
Throat irritation 23.23 9.84 40 200450 35264 70692690
Stridor 23.12 9.84 47 200443 5029 70722925
Torsade de pointes 23.07 9.84 107 200383 18009 70709945
Skin exfoliation 23.04 9.84 66 200424 48560 70679394
Application site pain 22.77 9.84 43 200447 4359 70723595
Balance disorder 22.77 9.84 155 200335 89973 70637981
Erythema 22.70 9.84 412 200078 199151 70528803
Troponin increased 22.55 9.84 100 200390 16514 70711440
Spinal cord compression 22.53 9.84 51 200439 5877 70722077
Tachyphylaxis 22.15 9.84 13 200477 318 70727636
Asphyxia 22.14 9.84 72 200418 10270 70717684
Limb discomfort 22.08 9.84 31 200459 29674 70698280
Fall 22.08 9.84 1028 199462 443068 70284886
Haemoglobin decreased 21.96 9.84 428 200062 204731 70523223
Blood pressure fluctuation 21.91 9.84 89 200401 58923 70669031
Depressed mood 21.87 9.84 58 200432 43762 70684192
Coagulopathy 21.86 9.84 165 200325 33084 70694870
Post procedural haemorrhage 21.86 9.84 83 200407 12783 70715171
Hepatic failure 21.76 9.84 254 200236 57371 70670583
Urticaria 21.71 9.84 327 200163 162722 70565232
Hypogonadism 21.49 9.84 23 200467 1373 70726581
Pseudopolyp 21.46 9.84 14 200476 415 70727539
Impaired healing 21.32 9.84 123 200367 74251 70653703
Cardiac failure 21.19 9.84 282 200208 143259 70584695
Joint injury 21.15 9.84 27 200463 26905 70701049
Hepatorenal syndrome 20.90 9.84 39 200451 3918 70724036
Seizure like phenomena 20.86 9.84 25 200465 1690 70726264
Drug eruption 20.69 9.84 51 200439 39445 70688509
Toxicologic test abnormal 20.67 9.84 22 200468 1305 70726649
Injection site haemorrhage 20.66 9.84 25 200465 25502 70702452
Intestinal ischaemia 20.64 9.84 78 200412 11986 70715968
Coronary artery disease 20.64 9.84 99 200391 62637 70665317
Pathogen resistance 20.54 9.84 6 200484 13273 70714681
Wrong product administered 20.52 9.84 61 200429 8290 70719664
Transplant rejection 20.51 9.84 13 200477 18158 70709796
Foetal heart rate decreased 20.49 9.84 6 200484 20 70727934
Muscle spasms 20.49 9.84 309 200181 153737 70574217
Head titubation 20.47 9.84 18 200472 842 70727112
Tongue disorder 20.41 9.84 6 200484 13221 70714733
Vision blurred 20.37 9.84 171 200319 94813 70633141
Dry skin 20.36 9.84 85 200405 55846 70672108
Renal impairment 20.35 9.84 542 199948 143395 70584559
Ear pain 20.32 9.84 29 200461 27570 70700384
Photosensitivity reaction 20.27 9.84 15 200475 19325 70708629
Myotonia 20.24 9.84 11 200479 231 70727723
Non-small cell lung cancer 20.23 9.84 51 200439 6296 70721658
Sinus congestion 20.20 9.84 12 200478 17361 70710593
Granulocytopenia 20.18 9.84 3 200487 10644 70717310
Vasoconstriction 20.17 9.84 16 200474 648 70727306
Febrile neutropenia 20.16 9.84 432 200058 203886 70524068
Eosinophil count increased 19.95 9.84 9 200481 15213 70712741
Post transplant lymphoproliferative disorder 19.92 9.84 3 200487 10542 70717412
Status epilepticus 19.83 9.84 128 200362 24398 70703556
Arterial haemorrhage 19.81 9.84 29 200461 2382 70725572
Intentional self-injury 19.80 9.84 37 200453 31613 70696341
Breast cancer female 19.77 9.84 3 200487 10483 70717471
Electrocardiogram ST segment depression 19.77 9.84 41 200449 4450 70723504
Sleep disorder due to a general medical condition 19.75 9.84 3 200487 10473 70717481
Product administration error 19.69 9.84 147 200343 29376 70698578
Blood pressure systolic increased 19.64 9.84 89 200401 57170 70670784
Injection site rash 19.56 9.84 11 200479 16399 70711555
Acute myeloid leukaemia 19.51 9.84 36 200454 30904 70697050
Manufacturing production issue 19.49 9.84 4 200486 0 70727954
Suicide attempt 19.46 9.84 138 200352 79372 70648582
Substance dependence 19.42 9.84 14 200476 490 70727464
Myocardial ischaemia 19.38 9.84 126 200364 24074 70703880
Foot deformity 19.21 9.84 18 200472 20637 70707317
Full blood count abnormal 19.15 9.84 42 200448 33836 70694118
Gastroenteritis 19.08 9.84 37 200453 31176 70696778
Oxidative stress 19.08 9.84 6 200484 27 70727927
Nystagmus 19.02 9.84 64 200426 9291 70718663
Pathological fracture 18.99 9.84 65 200425 9518 70718436
Paralysis 18.99 9.84 76 200414 11996 70715958
Cardiac output decreased 18.96 9.84 24 200466 1716 70726238
Pyrexia 18.96 9.84 1468 199022 605484 70122470
Respiratory distress 18.93 9.84 237 200253 54413 70673541
Ischaemic cerebral infarction 18.86 9.84 28 200462 2329 70725625
Dyspepsia 18.81 9.84 161 200329 88916 70639038
Acute chest syndrome 18.74 9.84 18 200472 944 70727010
Enthesopathy 18.57 9.84 4 200486 10865 70717089
Aspergillus infection 18.55 9.84 14 200476 17854 70710100
Ventricular extrasystoles 18.52 9.84 101 200389 18125 70709829
Pulmonary toxicity 18.40 9.84 4 200486 10794 70717160
Exposure via ingestion 18.36 9.84 42 200448 4873 70723081
Endotracheal intubation 18.34 9.84 39 200451 4307 70723647
Polyarthritis 18.29 9.84 4 200486 10752 70717202
Gastric disorder 18.28 9.84 42 200448 33280 70694674
Eye swelling 18.20 9.84 24 200466 23590 70704364
Mastocytosis 18.18 9.84 13 200477 449 70727505
Ventricular arrhythmia 18.12 9.84 56 200434 7774 70720180
Mydriasis 18.12 9.84 92 200398 16061 70711893
Mechanical ventilation complication 18.09 9.84 6 200484 33 70727921
Limb injury 18.05 9.84 28 200462 25724 70702230
Subcutaneous emphysema 18.01 9.84 23 200467 1659 70726295
Nodule 17.88 9.84 18 200472 19951 70708003
Drug detoxification 17.77 9.84 11 200479 297 70727657
Postoperative respiratory distress 17.72 9.84 5 200485 14 70727940
Syncope 17.64 9.84 346 200144 165363 70562591
Colitis ulcerative 17.62 9.84 44 200446 33879 70694075
Lymphadenectomy 17.61 9.84 19 200471 1145 70726809
Drug specific antibody 17.60 9.84 27 200463 2312 70725642
Cyst 17.60 9.84 77 200413 12642 70715312
Glycosylated haemoglobin increased 17.58 9.84 14 200476 17377 70710577
Amylase increased 17.47 9.84 66 200424 10142 70717812
Agranulocytosis 17.45 9.84 57 200433 40241 70687713
Acute respiratory failure 17.44 9.84 230 200260 53435 70674519
Disseminated intravascular coagulation 17.41 9.84 158 200332 33440 70694514
Heavy menstrual bleeding 17.38 9.84 7 200483 12658 70715296
Middle insomnia 17.36 9.84 9 200481 14044 70713910
Tendon rupture 17.36 9.84 5 200485 11164 70716790
Therapy interrupted 17.35 9.84 27 200463 24775 70703179
Accidental poisoning 17.22 9.84 22 200468 1588 70726366
Cardiac failure chronic 17.10 9.84 4 200486 10265 70717689
Deformity 17.08 9.84 57 200433 8240 70719714
Vaccination site reaction 17.07 9.84 8 200482 121 70727833
Ocular hyperaemia 17.07 9.84 27 200463 24612 70703342
Weight bearing difficulty 17.03 9.84 30 200460 2882 70725072
Weight decreased 17.00 9.84 711 199779 309777 70418177
Sphincter of Oddi dysfunction 16.97 9.84 12 200478 407 70727547
Product storage error 16.97 9.84 10 200480 14531 70713423
Pituitary apoplexy 16.95 9.84 9 200481 180 70727774
Agitation postoperative 16.92 9.84 7 200483 77 70727877
Quadriplegia 16.92 9.84 31 200459 3071 70724883
Adverse event 16.89 9.84 77 200413 49384 70678570
Skin sensitisation 16.85 9.84 16 200474 827 70727127
Atrioventricular block complete 16.76 9.84 86 200404 15077 70712877
Medical device site pain 16.74 9.84 10 200480 253 70727701
Blood ethanol 16.72 9.84 8 200482 127 70727827
Postpartum haemorrhage 16.72 9.84 21 200469 1490 70726464
Tooth loss 16.70 9.84 48 200442 6402 70721552
Urinary tract infection 16.66 9.84 556 199934 248213 70479741
Rhythm idioventricular 16.63 9.84 13 200477 515 70727439
Cardiac massage 16.57 9.84 5 200485 19 70727935
Diabetes mellitus inadequate control 16.47 9.84 24 200466 22621 70705333
Gastrointestinal scarring 16.42 9.84 10 200480 262 70727692
Blood pressure systolic abnormal 16.35 9.84 8 200482 12901 70715053
Lower respiratory tract infection bacterial 16.32 9.84 16 200474 861 70727093
Postmortem blood drug level abnormal 16.29 9.84 14 200476 635 70727319
Uveitis 16.24 9.84 11 200479 14834 70713120
Therapeutic response shortened 16.19 9.84 8 200482 12830 70715124
Panniculitis 16.19 9.84 5 200485 10671 70717283
Areflexia 16.16 9.84 41 200449 5081 70722873
Coeliac disease 16.11 9.84 3 200487 9030 70718924
Dyslipidaemia 16.11 9.84 4 200486 9856 70718098
Pneumonitis chemical 16.09 9.84 11 200479 353 70727601
Foot fracture 16.07 9.84 19 200471 19581 70708373
Tachyarrhythmia 16.05 9.84 47 200443 6335 70721619
Musculoskeletal discomfort 16.05 9.84 16 200474 17816 70710138
Aspiration 16.02 9.84 95 200395 17580 70710374
Intentional product use issue 16.02 9.84 449 200041 119693 70608261
Vasculitis 15.99 9.84 19 200471 19539 70708415
Eye irritation 15.96 9.84 16 200474 17772 70710182
Uterine hypertonus 15.96 9.84 10 200480 276 70727678
Lip dry 15.93 9.84 4 200486 9781 70718173
Respiratory tract infection bacterial 15.91 9.84 22 200468 1715 70726239
Exposure to extreme temperature 15.84 9.84 4 200486 6 70727948
Renal cyst 15.83 9.84 9 200481 13336 70714618
Eye pruritus 15.83 9.84 11 200479 14636 70713318
Acne 15.82 9.84 29 200461 24960 70702994
Bezold-Jarisch reflex 15.81 9.84 5 200485 23 70727931
Hyperlipidaemia 15.74 9.84 27 200463 23836 70704118
Chemical peritonitis 15.68 9.84 10 200480 285 70727669
Piloerection 15.67 9.84 12 200478 461 70727493
Prinzmetal angina 15.64 9.84 21 200469 1591 70726363
Neutropenia 15.56 9.84 582 199908 256574 70471380
Hypermagnesaemia 15.54 9.84 18 200472 1173 70726781
Product use in unapproved indication 15.52 9.84 457 200033 207021 70520933
Intensive care unit delirium 15.47 9.84 6 200484 55 70727899
Hypercholesterolaemia 15.47 9.84 17 200473 18100 70709854
Oedema 15.46 9.84 203 200287 103378 70624576
Preternatural anus 15.42 9.84 7 200483 98 70727856
Grip strength decreased 15.39 9.84 13 200477 15672 70712282
Synovial cyst 15.39 9.84 3 200487 8739 70719215
Rash maculo-papular 15.35 9.84 82 200408 50463 70677491
Melaena 15.20 9.84 95 200395 56260 70671694
Type I hypersensitivity 15.19 9.84 33 200457 3699 70724255
Post-traumatic neck syndrome 15.17 9.84 23 200467 1950 70726004
Schizophrenia 15.14 9.84 15 200475 16753 70711201
Disease complication 15.14 9.84 37 200453 4480 70723474
Long QT syndrome 15.13 9.84 41 200449 5286 70722668
Heart rate irregular 15.12 9.84 39 200451 29704 70698250
Pancreatitis acute 15.09 9.84 71 200419 45153 70682801
Hepatic cirrhosis 15.09 9.84 41 200449 30690 70697264
Disease recurrence 15.06 9.84 55 200435 37548 70690406
Skin haemorrhage 15.03 9.84 5 200485 10175 70717779
Decorticate posture 15.02 9.84 10 200480 307 70727647
Bladder cancer 14.92 9.84 16 200474 17226 70710728
Atelectasis 14.90 9.84 136 200354 28826 70699128
Skin cancer 14.85 9.84 10 200480 13526 70714428
Nausea 14.83 9.84 2679 197811 849409 69878545
Endometriosis 14.78 9.84 30 200460 3206 70724748
Atrioventricular dissociation 14.77 9.84 10 200480 316 70727638
Extradural haematoma 14.71 9.84 27 200463 2678 70725276
Visual acuity reduced 14.68 9.84 36 200454 27894 70700060
Arthrofibrosis 14.64 9.84 7 200483 111 70727843
Cerebral artery perforation 14.61 9.84 3 200487 0 70727954
Peroneal nerve palsy postoperative 14.61 9.84 3 200487 0 70727954
Drug effect faster than expected 14.61 9.84 3 200487 0 70727954
Pulse pressure abnormal 14.61 9.84 3 200487 0 70727954
Metastases to spine 14.61 9.84 33 200457 3796 70724158
Blood catecholamines increased 14.58 9.84 5 200485 31 70727923
Carpal tunnel syndrome 14.57 9.84 16 200474 17041 70710913
Anxiety 14.56 9.84 762 199728 219568 70508386
Pancreatic carcinoma metastatic 14.55 9.84 33 200457 3807 70724147
Respiratory alkalosis 14.40 9.84 34 200456 4027 70723927
Neuroendocrine tumour of the lung metastatic 14.37 9.84 7 200483 116 70727838
Device dislocation 14.36 9.84 26 200464 22481 70705473
Rectal haemorrhage 14.34 9.84 118 200372 65713 70662241
Gouty tophus 14.31 9.84 10 200480 333 70727621
Posturing 14.30 9.84 16 200474 1004 70726950
Euthyroid sick syndrome 14.27 9.84 6 200484 69 70727885
Metabolic encephalopathy 14.25 9.84 54 200436 8309 70719645
Metastases to meninges 14.24 9.84 29 200461 3107 70724847
Sopor 14.20 9.84 143 200347 31124 70696830
Locked-in syndrome 14.19 9.84 13 200477 642 70727312
Catecholamine crisis 14.18 9.84 5 200485 34 70727920
Product packaging issue 14.18 9.84 16 200474 1014 70726940
Blood ethanol increased 14.14 9.84 13 200477 645 70727309
Ileus 14.13 9.84 117 200373 24120 70703834
Laryngeal oedema 14.12 9.84 50 200440 7445 70720509
Spinal cord injury 14.11 9.84 16 200474 1019 70726935
Bone marrow failure 14.07 9.84 81 200409 48929 70679025
Colitis microscopic 14.05 9.84 4 200486 9001 70718953
International normalised ratio increased 14.04 9.84 153 200337 80573 70647381
Intervertebral disc compression 13.89 9.84 16 200474 1037 70726917
Sweat gland disorder 13.88 9.84 8 200482 189 70727765
Pulmonary fibrosis 13.86 9.84 50 200440 34260 70693694
Impaired quality of life 13.84 9.84 4 200486 8912 70719042
Haematotoxicity 13.83 9.84 11 200479 13663 70714291
Chest pain 13.82 9.84 575 199915 250685 70477269
Lymphadenopathy 13.82 9.84 81 200409 48710 70679244
Pulmonary alveolar haemorrhage 13.76 9.84 62 200428 10307 70717647
Device failure 13.75 9.84 42 200448 5793 70722161
Dermal absorption impaired 13.74 9.84 4 200486 13 70727941
Cholelithiasis 13.72 9.84 78 200412 47262 70680692
Spinal epidural haematoma 13.71 9.84 18 200472 1335 70726619
Obesity 13.69 9.84 35 200455 26736 70701218
Hyponatraemia 13.68 9.84 346 200144 159741 70568213
Motor dysfunction 13.66 9.84 73 200417 12997 70714957
Procedural vomiting 13.66 9.84 13 200477 674 70727280
Stupor 13.65 9.84 45 200445 6464 70721490
Environmental exposure 13.62 9.84 10 200480 360 70727594
Pneumothorax 13.62 9.84 122 200368 25724 70702230
Blood glucose decreased 13.62 9.84 30 200460 24129 70703825
Manipulation 13.62 9.84 6 200484 78 70727876
Medical device site fistula 13.59 9.84 5 200485 39 70727915
Mucormycosis 13.59 9.84 3 200487 8011 70719943
Intentional overdose 13.59 9.84 196 200294 98239 70629715
Interstitial lung disease 13.57 9.84 211 200279 104474 70623480
Therapeutic response decreased 13.56 9.84 103 200387 58350 70669604
Post procedural haematoma 13.49 9.84 24 200466 2324 70725630
Vein disorder 13.46 9.84 35 200455 4403 70723551
Paraesthesia 13.41 9.84 311 200179 145226 70582728
Rhabdomyolysis 13.36 9.84 360 200130 95400 70632554
Hepatic cytolysis 13.32 9.84 21 200469 19171 70708783
Facial nerve disorder 13.30 9.84 13 200477 697 70727257
Nerve stimulation test abnormal 13.30 9.84 4 200486 15 70727939
Sputum increased 13.27 9.84 33 200457 4039 70723915
Vitamin K deficiency 13.27 9.84 13 200477 699 70727255
Hypovolaemia 13.26 9.84 84 200406 15909 70712045
Hypercreatininaemia 13.23 9.84 14 200476 825 70727129
Squamous cell carcinoma of skin 13.14 9.84 10 200480 12702 70715252
Wound dehiscence 13.09 9.84 43 200447 6165 70721789
Tracheal pain 12.97 9.84 5 200485 45 70727909
Carbohydrate antigen 15-3 12.97 9.84 6 200484 88 70727866
Sinus disorder 12.92 9.84 21 200469 18938 70709016
Food allergy 12.91 9.84 4 200486 8520 70719434
Hemiplegic migraine 12.91 9.84 6 200484 89 70727865
Asthenia 12.88 9.84 1116 199374 456550 70271404
Epstein-Barr virus infection 12.87 9.84 11 200479 13187 70714767
Adverse drug reaction 12.85 9.84 93 200397 53251 70674703
Conjunctivitis 12.85 9.84 28 200462 22608 70705346
Procedural nausea 12.83 9.84 13 200477 728 70727226
Liver injury 12.78 9.84 66 200424 40969 70686985
Capillary nail refill test abnormal 12.78 9.84 5 200485 47 70727907
Abdominal compartment syndrome 12.74 9.84 18 200472 1431 70726523
Creatinine renal clearance decreased 12.74 9.84 18 200472 17182 70710772
Carcinoembryonic antigen 12.73 9.84 6 200484 92 70727862
Hypophonesis 12.72 9.84 4 200486 18 70727936
Visual field defect 12.71 9.84 4 200486 8434 70719520
Joint effusion 12.69 9.84 15 200475 15462 70712492
Yawning 12.64 9.84 17 200473 1290 70726664
Second primary malignancy 12.58 9.84 11 200479 13040 70714914
Hippocampal atrophy 12.54 9.84 3 200487 3 70727951
End stage renal disease 12.51 9.84 8 200482 11125 70716829
Laryngeal cancer metastatic 12.51 9.84 5 200485 50 70727904
Foreign body 12.50 9.84 25 200465 2643 70725311
Product administered to patient of inappropriate age 12.50 9.84 36 200454 4807 70723147
Skin plaque 12.49 9.84 6 200484 9777 70718177
Lagophthalmos 12.48 9.84 10 200480 411 70727543
Complex regional pain syndrome 12.47 9.84 20 200470 1780 70726174
Monoplegia 12.44 9.84 30 200460 3601 70724353
Fungal infection 12.40 9.84 59 200431 37408 70690546
Large intestine anastomosis 12.39 9.84 6 200484 98 70727856
Mean arterial pressure increased 12.34 9.84 5 200485 52 70727902
Exposure via breast milk 12.33 9.84 14 200476 893 70727061
Procedural haemorrhage 12.31 9.84 34 200456 4433 70723521
Muscle atrophy 12.30 9.84 60 200430 10310 70717644
Cardiac disorder 12.27 9.84 108 200382 59307 70668647
Product communication issue 12.27 9.84 13 200477 767 70727187
Faeces discoloured 12.26 9.84 37 200453 26772 70701182
Infusion site mass 12.24 9.84 16 200474 1181 70726773
Psychomotor skills impaired 12.19 9.84 33 200457 4251 70723703
Bronchial disorder 12.18 9.84 23 200467 2331 70725623
Hypoaesthesia 12.16 9.84 336 200154 153403 70574551
Thyroid disorder 12.15 9.84 11 200479 12821 70715133
Pancreatic carcinoma 12.11 9.84 70 200420 12834 70715120
Leukopenia 12.11 9.84 220 200270 106340 70621614
Sedation complication 12.10 9.84 72 200418 13338 70714616
Optic neuritis 12.08 9.84 5 200485 8895 70719059
Rhinitis 12.05 9.84 9 200481 11538 70716416
Electrocardiogram T wave alternans 12.01 9.84 5 200485 56 70727898
Acute graft versus host disease 12.00 9.84 6 200484 9556 70718398
Oesophageal intramural haematoma 11.97 9.84 6 200484 106 70727848
Lung disorder 11.96 9.84 132 200358 69352 70658602
Uterine atony 11.93 9.84 7 200483 171 70727783
Meningococcal bacteraemia 11.91 9.84 4 200486 23 70727931
Forced expiratory volume decreased 11.88 9.84 3 200487 7311 70720643
Mechanical ventilation 11.88 9.84 24 200466 2557 70725397
Swollen tongue 11.87 9.84 59 200431 36987 70690967
Low density lipoprotein increased 11.84 9.84 4 200486 8061 70719893
Blood urine present 11.78 9.84 23 200467 19330 70708624
Ketoacidosis 11.78 9.84 3 200487 7266 70720688
Listless 11.74 9.84 29 200461 3534 70724420
Haematochezia 11.74 9.84 141 200349 72940 70655014
Cutaneous vasculitis 11.70 9.84 3 200487 7235 70720719
Pharyngitis 11.69 9.84 25 200465 20326 70707628
Suicidal ideation 11.67 9.84 133 200357 69463 70658491
Respiratory tract congestion 11.62 9.84 20 200470 17633 70710321
Eye disorder 11.56 9.84 26 200464 20759 70707195
Respiratory paralysis 11.56 9.84 5 200485 62 70727892
Hypotonia 11.55 9.84 65 200425 11800 70716154
Fear of death 11.54 9.84 17 200473 1404 70726550
Laryngeal obstruction 11.53 9.84 6 200484 115 70727839
Burkholderia test positive 11.51 9.84 11 200479 573 70727381
Spinal cord oedema 11.48 9.84 9 200481 358 70727596
Pollakiuria 11.48 9.84 52 200438 33409 70694545
Muscle spasticity 11.47 9.84 24 200466 19665 70708289
Metastatic neoplasm 11.47 9.84 34 200456 4614 70723340
Abscess neck 11.44 9.84 15 200475 1111 70726843
Unintentional medical device removal 11.43 9.84 3 200487 7121 70720833
Harlequin syndrome 11.42 9.84 5 200485 64 70727890
Myocardial stunning 11.41 9.84 7 200483 186 70727768
Laryngitis 11.41 9.84 13 200477 13618 70714336
Secretion discharge 11.39 9.84 69 200421 12864 70715090
Impaired gastric emptying 11.39 9.84 55 200435 9411 70718543
Refusal of treatment by relative 11.36 9.84 12 200478 706 70727248
Sympatholysis 11.34 9.84 3 200487 6 70727948
Decerebrate posture 11.31 9.84 7 200483 189 70727765
Blood pressure diastolic increased 11.29 9.84 11 200479 12380 70715574
Dysphonia 11.28 9.84 89 200401 50011 70677943
Haematuria traumatic 11.28 9.84 7 200483 190 70727764
Disturbance in social behaviour 11.25 9.84 31 200459 4036 70723918
Gastrointestinal motility disorder 11.24 9.84 38 200452 5528 70722426
Skin disorder 11.13 9.84 46 200444 30311 70697643
Clinical trial participant 11.13 9.84 6 200484 124 70727830
Radiculopathy 11.11 9.84 40 200450 6005 70721949
Hypertonia 11.11 9.84 42 200448 6456 70721498
Gout 11.07 9.84 31 200459 22975 70704979
Infrequent bowel movements 11.01 9.84 17 200473 1464 70726490
Lymphopenia 10.97 9.84 40 200450 27319 70700635
Premature separation of placenta 10.97 9.84 15 200475 1157 70726797
Tumour haemorrhage 10.93 9.84 29 200461 3693 70724261
Implant site extravasation 10.92 9.84 12 200478 738 70727216
Drug screen negative 10.90 9.84 8 200482 288 70727666
Drug dose titration not performed 10.80 9.84 12 200478 747 70727207
Rash pustular 10.80 9.84 8 200482 10300 70717654
Hypogammaglobulinaemia 10.79 9.84 10 200480 11528 70716426
Gonadotrophin deficiency 10.79 9.84 4 200486 32 70727922
Cerebral ischaemia 10.78 9.84 58 200432 10354 70717600
Antinuclear antibody positive 10.73 9.84 3 200487 6830 70721124
Bile output abnormal 10.68 9.84 4 200486 33 70727921
Spontaneous haemorrhage 10.66 9.84 10 200480 509 70727445
Pneumomediastinum 10.66 9.84 27 200463 3343 70724611
Cytomegalovirus infection reactivation 10.60 9.84 3 200487 6778 70721176
Urine amphetamine positive 10.59 9.84 5 200485 77 70727877
Generalised onset non-motor seizure 10.59 9.84 5 200485 77 70727877
Glaucoma 10.58 9.84 22 200468 18070 70709884
Myopathy 10.58 9.84 23 200467 18589 70709365
Chronic graft versus host disease 10.58 9.84 3 200487 6767 70721187
Physical product label issue 10.58 9.84 4 200486 34 70727920
Intraocular pressure increased 10.56 9.84 6 200484 8895 70719059
Procedural headache 10.55 9.84 6 200484 138 70727816
Trichoglossia 10.55 9.84 10 200480 516 70727438
Influenza like illness 10.51 9.84 126 200364 65205 70662749
Taste disorder 10.50 9.84 10 200480 11375 70716579
Excessive dynamic airway collapse 10.48 9.84 3 200487 9 70727945
Gross motor delay 10.47 9.84 5 200485 79 70727875
Ankle fracture 10.45 9.84 17 200473 15327 70712627
Bacterial infection 10.44 9.84 39 200451 26453 70701501
Phaeochromocytoma crisis 10.43 9.84 8 200482 308 70727646
Septic shock 10.43 9.84 402 200088 111856 70616098
Gastrointestinal infection 10.42 9.84 7 200483 9484 70718470
Throat tightness 10.42 9.84 36 200454 24986 70702968
Parkinsonism 10.42 9.84 17 200473 15308 70712646
Device use error 10.40 9.84 3 200487 6693 70721261
Metastases to lung 10.39 9.84 81 200409 16403 70711551
Monoparesis 10.37 9.84 26 200464 3198 70724756
Treatment noncompliance 10.37 9.84 83 200407 46491 70681463
Post laminectomy syndrome 10.34 9.84 8 200482 312 70727642
Bronchopulmonary aspergillosis 10.33 9.84 28 200462 20974 70706980
Uterine hypotonus 10.31 9.84 5 200485 82 70727872
Substance use disorder 10.30 9.84 11 200479 655 70727299
Hot flush 10.30 9.84 90 200400 49494 70678460
Mouth ulceration 10.28 9.84 56 200434 34293 70693661
Caesarean section 10.27 9.84 62 200428 11545 70716409
Reversal of sedation 10.24 9.84 3 200487 10 70727944
Hypothermia 10.24 9.84 96 200394 20498 70707456
Skin necrosis 10.23 9.84 19 200471 16272 70711682
Feeling cold 10.23 9.84 114 200376 25456 70702498
Chronic obstructive pulmonary disease 10.23 9.84 156 200334 77485 70650469
Nephrotic syndrome 10.22 9.84 9 200481 10631 70717323
Pupillary reflex impaired 10.22 9.84 26 200464 3228 70724726
Alanine aminotransferase abnormal 10.20 9.84 5 200485 8054 70719900
Respiratory tract infection 10.17 9.84 74 200416 42324 70685630
Skin test positive 10.14 9.84 14 200476 1090 70726864
Ovarian cyst 10.10 9.84 11 200479 11761 70716193
Application site burn 10.10 9.84 12 200478 804 70727150
Tumour necrosis 10.07 9.84 18 200472 1749 70726205
Myocarditis 10.06 9.84 24 200466 18769 70709185
Gastric cancer 10.04 9.84 51 200439 8904 70719050
Blood creatine phosphokinase MB increased 10.02 9.84 23 200467 2674 70725280
Oculogyric crisis 10.02 9.84 23 200467 2675 70725279
Femoral nerve injury 10.01 9.84 4 200486 40 70727914
Eastern Cooperative Oncology Group performance status worsened 9.97 9.84 17 200473 1591 70726363
Polyneuropathy in malignant disease 9.96 9.84 6 200484 154 70727800
Rales 9.89 9.84 21 200469 17114 70710840
Proteinuria 9.87 9.84 46 200444 29328 70698626
Urticaria papular 9.86 9.84 6 200484 157 70727797

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




🐶 Veterinary Drug Use

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

🐶 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 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 DISCN SYSTEM IONTOPHORESIS, TRANSDERMAL 6881208 April 19, 2022 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
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
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
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 0093-7866 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 0093-7868 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 0093-7870 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 0378-9121 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 0378-9123 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 0378-9125 PATCH 37.50 ug TRANSDERMAL ANDA 34 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9126 PATCH 62.50 ug TRANSDERMAL ANDA 34 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9127 PATCH 87.50 ug TRANSDERMAL ANDA 34 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9000 PATCH, EXTENDED RELEASE 100 ug TRANSDERMAL ANDA 38 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9012 PATCH, EXTENDED RELEASE 12.50 ug TRANSDERMAL ANDA 38 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9025 PATCH, EXTENDED RELEASE 25 ug TRANSDERMAL ANDA 38 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9037 PATCH, EXTENDED RELEASE 37.50 ug TRANSDERMAL ANDA 38 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9050 PATCH, EXTENDED RELEASE 50 ug TRANSDERMAL ANDA 38 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9062 PATCH, EXTENDED RELEASE 62.50 ug TRANSDERMAL ANDA 38 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9075 PATCH, EXTENDED RELEASE 75 ug TRANSDERMAL ANDA 38 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9100 PATCH, EXTENDED RELEASE 100 ug TRANSDERMAL ANDA 38 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9112 PATCH, EXTENDED RELEASE 12.50 ug TRANSDERMAL ANDA 38 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9125 PATCH, EXTENDED RELEASE 25 ug TRANSDERMAL ANDA 38 sections