diazepam Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
diazepam derivatives 852 439-14-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • RO-5-2807
  • diazepam
  • valium
A benzodiazepine with anticonvulsant, anxiolytic, sedative, muscle relaxant, and amnesic properties and a long duration of action. Its actions are mediated by enhancement of GAMMA-AMINOBUTYRIC ACID activity.
  • Molecular weight: 284.74
  • Formula: C16H13ClN2O
  • CLOGP: 2.96
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 0
  • TPSA: 32.67
  • ALOGS: -4.37
  • ROTB: 1

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
10 mg O
10 mg P
10 mg R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.06 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 2.01 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.38 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.02 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 42 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 15, 1963 FDA ROCHE

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 2159.52 9.77 1591 122322 61817 46500332
Toxicity to various agents 1881.31 9.77 2548 121365 209218 46352931
Completed suicide 1226.84 9.77 1712 122201 144208 46417941
Intentional overdose 1096.04 9.77 1090 122823 63854 46498295
Suicide attempt 812.76 9.77 860 123053 54176 46507973
Coma 584.68 9.77 747 123166 57602 46504547
Overdose 552.34 9.77 979 122934 101000 46461149
Intentional self-injury 509.07 9.77 459 123454 23707 46538442
Respiratory arrest 450.93 9.77 501 123412 33315 46528834
Drug dependence 431.02 9.77 384 123529 19517 46542632
Somnolence 414.22 9.77 1126 122787 155395 46406754
Drug withdrawal syndrome 393.44 9.77 422 123491 26962 46535187
Sopor 392.97 9.77 364 123549 19464 46542685
Rheumatoid arthritis 390.71 9.77 81 123832 240134 46322015
Poisoning 383.08 9.77 309 123604 13685 46548464
Poisoning deliberate 343.72 9.77 231 123682 7695 46554454
Suicidal ideation 309.69 9.77 545 123368 55837 46506312
Intentional product misuse 271.12 9.77 465 123448 46663 46515486
Agitation 254.51 9.77 496 123417 54919 46507230
Respiratory depression 247.51 9.77 222 123691 11378 46550771
Cardio-respiratory arrest 240.62 9.77 507 123406 59362 46502787
Cardiac arrest 238.41 9.77 650 123263 89749 46472400
Depressed level of consciousness 232.23 9.77 437 123476 47132 46515017
Aggression 213.26 9.77 282 123631 22462 46539687
Withdrawal syndrome 190.68 9.77 238 123675 17896 46544253
Miosis 184.30 9.77 148 123765 6509 46555640
Anxiety 174.52 9.77 947 122966 181010 46381139
Neuroleptic malignant syndrome 162.51 9.77 173 123740 10949 46551200
Bradypnoea 159.85 9.77 100 123813 2939 46559210
Psychotic disorder 158.30 9.77 244 123669 22377 46539772
Seizure 155.48 9.77 693 123220 122361 46439788
Schizophrenia 152.02 9.77 148 123765 8420 46553729
Disturbance in attention 145.46 9.77 283 123630 31277 46530872
Drug interaction 140.85 9.77 972 122941 202122 46360027
Sedation 131.62 9.77 226 123687 22684 46539465
Infusion related reaction 131.43 9.77 52 123861 101156 46460993
Anaemia 130.41 9.77 305 123608 255474 46306675
Diarrhoea 129.82 9.77 912 123001 558690 46003459
Treatment failure 127.32 9.77 44 123869 93043 46469106
Panic attack 120.67 9.77 203 123710 20039 46542110
Synovitis 118.96 9.77 12 123901 61063 46501086
Serotonin syndrome 118.77 9.77 223 123690 23997 46538152
Drug ineffective 117.08 9.77 1194 122719 676644 45885505
Depression 115.44 9.77 810 123103 169294 46392855
Accidental overdose 114.03 9.77 197 123716 19869 46542280
Tremor 113.53 9.77 606 123307 115033 46447116
Contraindicated product administered 112.46 9.77 36 123877 79911 46482238
Cough 110.69 9.77 283 123630 229966 46332183
Nightmare 109.14 9.77 174 123739 16424 46545725
Restlessness 108.15 9.77 221 123692 25303 46536846
Status epilepticus 108.09 9.77 158 123755 13821 46548328
Drug intolerance 103.96 9.77 143 123770 146906 46415243
Pemphigus 102.61 9.77 4 123909 45270 46516879
Drug withdrawal convulsions 101.90 9.77 56 123857 1285 46560864
Joint swelling 101.66 9.77 178 123735 165895 46396254
Febrile neutropenia 98.44 9.77 65 123848 94562 46467587
Arthralgia 97.73 9.77 568 123345 364035 46198114
Rash 97.37 9.77 552 123361 355960 46206189
Bradyphrenia 94.73 9.77 99 123814 6131 46556018
Peripheral swelling 92.65 9.77 174 123739 157897 46404252
Substance abuse 91.36 9.77 81 123832 4086 46558063
Tachycardia 87.05 9.77 506 123407 99116 46463033
Hypomania 85.83 9.77 80 123833 4308 46557841
Dyspnoea 85.15 9.77 917 122996 514631 46047518
Agoraphobia 84.49 9.77 33 123880 331 46561818
Exposure via ingestion 81.25 9.77 70 123843 3397 46558752
Systemic lupus erythematosus 79.01 9.77 37 123876 65143 46497006
Off label use 77.43 9.77 641 123272 379200 46182949
Mydriasis 76.88 9.77 116 123797 10437 46551712
Salivary hypersecretion 76.56 9.77 90 123823 6355 46555794
Nasopharyngitis 76.50 9.77 186 123727 153812 46408337
Acute kidney injury 76.37 9.77 344 123569 235511 46326638
Thrombocytopenia 76.23 9.77 137 123776 126444 46435705
Therapeutic product effect decreased 75.31 9.77 65 123848 82536 46479613
Irritability 72.11 9.77 204 123709 28742 46533407
Disease progression 71.58 9.77 82 123831 91218 46470931
Sinusitis 71.57 9.77 148 123765 129620 46432529
Alopecia 69.53 9.77 211 123702 162203 46399946
Hypotonia 69.48 9.77 97 123816 8132 46554017
Dissociation 68.00 9.77 49 123864 1828 46560321
Neutropenia 67.98 9.77 177 123736 143027 46419122
Urinary retention 67.21 9.77 186 123727 25875 46536274
Hypothermia 67.12 9.77 118 123795 12065 46550084
Muscle rigidity 66.27 9.77 105 123808 9856 46552293
Therapeutic product effect incomplete 64.79 9.77 67 123846 78086 46484063
Accidental death 62.17 9.77 46 123867 1789 46560360
Confusional state 61.50 9.77 672 123241 159220 46402929
Infection 61.23 9.77 168 123745 133424 46428725
Asphyxia 61.00 9.77 73 123840 5253 46556896
Psychomotor hyperactivity 60.77 9.77 99 123814 9514 46552635
Haemoglobin decreased 60.73 9.77 160 123753 128789 46433360
Dysarthria 60.59 9.77 228 123685 37270 46524879
Fatigue 59.74 9.77 1199 122714 607498 45954651
Akathisia 59.36 9.77 87 123826 7627 46554522
Hyperhidrosis 59.16 9.77 423 123490 88885 46473264
Abnormal behaviour 59.03 9.77 155 123758 20903 46541246
Tearfulness 58.08 9.77 63 123850 4072 46558077
Coma scale abnormal 57.97 9.77 69 123844 4937 46557212
Altered state of consciousness 57.62 9.77 164 123749 23184 46538965
Parkinsonism 57.38 9.77 87 123826 7861 46554288
Loss of consciousness 55.90 9.77 484 123429 107754 46454395
Mania 55.84 9.77 102 123811 10744 46551405
Respiratory acidosis 55.72 9.77 75 123838 6073 46556076
Malignant neoplasm progression 55.72 9.77 54 123859 64872 46497277
Generalised tonic-clonic seizure 55.18 9.77 178 123735 26944 46535205
Disorientation 54.37 9.77 218 123695 36700 46525449
Arthropathy 54.35 9.77 88 123825 84612 46477537
Hallucination, auditory 53.93 9.77 100 123813 10656 46551493
Dependence 53.59 9.77 43 123870 1888 46560261
Interstitial lung disease 53.51 9.77 39 123874 53910 46508239
Abdominal discomfort 53.49 9.77 213 123700 150952 46411197
Gastrointestinal haemorrhage 52.89 9.77 77 123836 77296 46484853
Dyskinesia 52.78 9.77 183 123730 28742 46533407
Bone marrow failure 52.47 9.77 8 123905 29661 46532488
Jaundice cholestatic 51.26 9.77 65 123848 4964 46557185
Platelet count decreased 51.08 9.77 119 123794 99905 46462244
Dystonia 50.70 9.77 100 123813 11157 46550992
Insomnia 50.19 9.77 663 123250 164261 46397888
Mood swings 50.10 9.77 124 123789 16128 46546021
Arthritis 49.91 9.77 80 123833 77236 46484913
General physical health deterioration 49.81 9.77 150 123763 115619 46446530
Injection site pain 48.90 9.77 135 123778 107017 46455132
Swelling 48.24 9.77 169 123744 124342 46437807
Extrapyramidal disorder 48.24 9.77 98 123815 11170 46550979
Glossodynia 48.16 9.77 29 123884 44344 46517805
Pleural effusion 47.96 9.77 92 123821 82860 46479289
Mucosal inflammation 47.42 9.77 22 123891 38954 46523195
Self-injurious ideation 47.05 9.77 43 123870 2257 46559892
Fluid retention 46.72 9.77 40 123873 51006 46511143
Sepsis 46.64 9.77 194 123719 135820 46426329
Derealisation 46.25 9.77 28 123885 775 46561374
Emotional disorder 45.60 9.77 101 123812 12223 46549926
Depersonalisation/derealisation disorder 45.14 9.77 30 123883 980 46561169
Drug abuser 44.96 9.77 49 123864 3184 46558965
Multiple sclerosis relapse 44.91 9.77 226 123687 41899 46520250
Stomatitis 44.72 9.77 70 123843 68227 46493922
Hallucination 44.43 9.77 255 123658 49696 46512453
Product dose omission issue 44.23 9.77 264 123649 168256 46393893
Stiff person syndrome 43.75 9.77 17 123896 168 46561981
Drug withdrawal syndrome neonatal 43.31 9.77 38 123875 1890 46560259
Pancytopenia 42.78 9.77 102 123811 84956 46477193
Pyrexia 42.73 9.77 660 123253 348142 46214007
Pain 42.72 9.77 953 122960 475995 46086154
Ataxia 42.64 9.77 106 123807 13824 46548325
Hypersensitivity 42.40 9.77 230 123683 150091 46412058
Cardiac failure congestive 42.31 9.77 115 123798 91635 46470514
Victim of child abuse 41.95 9.77 10 123903 11 46562138
C-reactive protein abnormal 41.88 9.77 4 123909 21266 46540883
Anger 41.47 9.77 95 123818 11757 46550392
Feeling of despair 41.40 9.77 36 123877 1769 46560380
Pruritus 41.06 9.77 428 123485 241924 46320225
Drowning 40.45 9.77 21 123892 428 46561721
Unresponsive to stimuli 40.40 9.77 181 123732 31993 46530156
Renal ischaemia 39.90 9.77 23 123890 580 46561569
Atrial fibrillation 39.86 9.77 141 123772 103449 46458700
Oropharyngeal pain 39.69 9.77 86 123827 74082 46488067
Herpes zoster 39.47 9.77 75 123838 67797 46494352
Device expulsion 39.43 9.77 12 123901 27530 46534619
Psychomotor skills impaired 39.22 9.77 38 123875 2148 46560001
Lethargy 39.02 9.77 251 123662 50920 46511229
Drug use disorder 38.99 9.77 42 123871 2693 46559456
Visceral congestion 38.98 9.77 18 123895 281 46561868
Cogwheel rigidity 38.86 9.77 32 123881 1458 46560691
Aspiration 38.57 9.77 81 123832 9450 46552699
Physical assault 38.19 9.77 27 123886 977 46561172
Pancreatic fibrosis 38.11 9.77 13 123900 85 46562064
Snoring 37.50 9.77 46 123867 3396 46558753
Catatonia 37.36 9.77 48 123865 3714 46558435
Depressed mood 37.11 9.77 181 123732 33138 46529011
Inflammation 36.95 9.77 45 123868 48736 46513413
Pericarditis 36.93 9.77 9 123904 23918 46538231
Cytomegalovirus infection 36.84 9.77 3 123910 18141 46544008
Drooling 36.78 9.77 44 123869 3165 46558984
PO2 increased 36.35 9.77 25 123888 865 46561284
Housebound 36.34 9.77 16 123897 222 46561927
Pneumonia aspiration 36.14 9.77 173 123740 31432 46530717
Psoriasis 35.88 9.77 99 123814 78505 46483644
Pulmonary arterial hypertension 35.87 9.77 12 123901 25916 46536233
Neoplasm progression 35.80 9.77 13 123900 26670 46535479
Gastric pH decreased 35.24 9.77 18 123895 354 46561795
Rhesus incompatibility 34.98 9.77 12 123901 80 46562069
Electrocardiogram QT prolonged 34.49 9.77 244 123669 51081 46511068
Blood creatinine increased 34.30 9.77 97 123816 76306 46485843
Diabetes insipidus 33.87 9.77 35 123878 2139 46560010
Injection site erythema 33.04 9.77 95 123818 74332 46487817
Injection site pruritus 33.01 9.77 34 123879 39709 46522440
PCO2 increased 32.85 9.77 27 123886 1227 46560922
Paranoia 32.82 9.77 81 123832 10516 46551633
Plasma cell myeloma 32.67 9.77 42 123871 44436 46517713
Right ventricular hypertrophy 32.48 9.77 21 123892 654 46561495
Chemical submission 32.32 9.77 15 123898 237 46561912
Erythema 32.27 9.77 234 123679 142586 46419563
Crying 32.06 9.77 126 123787 21015 46541134
Delusion 32.02 9.77 83 123830 11105 46551044
Speech disorder 31.75 9.77 184 123729 35983 46526166
Psychomotor retardation 31.71 9.77 41 123872 3192 46558957
Pyramidal tract syndrome 31.18 9.77 16 123897 318 46561831
Right ventricular dilatation 31.16 9.77 23 123890 891 46561258
Flashback 30.67 9.77 12 123901 121 46562028
Cardiac failure 30.63 9.77 109 123804 79839 46482310
Sleep disorder 30.59 9.77 221 123692 46574 46515575
Delirium 30.50 9.77 186 123727 37042 46525107
Panic reaction 30.42 9.77 43 123870 3646 46558503
Injection site reaction 30.42 9.77 50 123863 47799 46514350
Urticaria 30.22 9.77 186 123727 117706 46444443
Myocardial fibrosis 30.17 9.77 19 123894 565 46561584
Drug diversion 30.11 9.77 22 123891 839 46561310
Mutism 29.96 9.77 26 123887 1274 46560875
Immobilisation prolonged 29.77 9.77 10 123903 62 46562087
Dyspnoea exertional 29.74 9.77 55 123858 50234 46511915
Mental disorder 29.55 9.77 128 123785 22297 46539852
Alcohol poisoning 29.17 9.77 33 123880 2235 46559914
Autonomic nervous system imbalance 29.02 9.77 34 123879 2392 46559757
Nasal congestion 29.00 9.77 52 123861 48061 46514088
Wound 28.85 9.77 43 123870 42759 46519390
Pneumonia 28.69 9.77 770 123143 375550 46186599
Hyperkalaemia 28.64 9.77 57 123856 50652 46511497
Blood pH decreased 28.44 9.77 35 123878 2592 46559557
Hypersomnia 28.44 9.77 98 123815 15341 46546808
Myoclonus 28.11 9.77 93 123820 14259 46547890
Fluid overload 27.81 9.77 19 123894 27166 46534983
Autonomic dysreflexia 27.81 9.77 13 123900 209 46561940
Knee arthroplasty 27.81 9.77 14 123899 23651 46538498
Impaired reasoning 27.77 9.77 9 123904 49 46562100
Conversion disorder 27.65 9.77 28 123885 1670 46560479
Hallucinations, mixed 27.60 9.77 42 123871 3807 46558342
Muscle spasms 27.33 9.77 469 123444 122644 46439505
Drug screen positive 27.25 9.77 42 123871 3849 46558300
Lactic acidosis 27.06 9.77 30 123883 33879 46528270
Electroencephalogram abnormal 26.97 9.77 41 123872 3713 46558436
Bronchitis 26.75 9.77 168 123745 105811 46456338
Generalised anxiety disorder 26.36 9.77 27 123886 1633 46560516
Abdominal pain 26.20 9.77 441 123472 229590 46332559
Upper respiratory tract infection 26.15 9.77 84 123829 63472 46498677
Antipsychotic drug level increased 26.02 9.77 37 123876 3155 46558994
Pain in extremity 25.68 9.77 508 123405 258172 46303977
Hyperprolactinaemia 25.41 9.77 35 123878 2897 46559252
Vision blurred 25.29 9.77 323 123590 79385 46482764
Asthma 25.28 9.77 141 123772 91401 46470748
Respiratory rate decreased 25.28 9.77 36 123877 3074 46559075
Posturing 25.13 9.77 16 123897 485 46561664
Renal failure 24.75 9.77 188 123725 113406 46448743
Nausea 24.65 9.77 1535 122378 685919 45876230
Asthenia 24.61 9.77 633 123280 310442 46251707
Amnesia 24.61 9.77 192 123721 41439 46520710
Somatic delusion 24.52 9.77 17 123896 596 46561553
Feeling of body temperature change 24.48 9.77 42 123871 4210 46557939
Dehydration 24.12 9.77 289 123624 159251 46402898
Apathy 24.05 9.77 57 123856 7211 46554938
Developmental delay 23.99 9.77 22 123891 1160 46560989
Memory impairment 23.95 9.77 312 123601 77025 46485124
Suicidal behaviour 23.94 9.77 31 123882 2417 46559732
C-reactive protein increased 23.71 9.77 78 123835 58512 46503637
Negativism 23.43 9.77 14 123899 378 46561771
Hypotonia neonatal 23.16 9.77 19 123894 861 46561288
Pneumocystis jirovecii pneumonia 23.02 9.77 6 123907 15242 46546907
Anticonvulsant drug level above therapeutic 22.73 9.77 15 123898 484 46561665
Ductus arteriosus premature closure 22.58 9.77 13 123900 327 46561822
Productive cough 22.31 9.77 65 123848 50650 46511499
Epilepsy 22.30 9.77 123 123790 23615 46538534
Myelodysplastic syndrome 22.21 9.77 7 123906 15704 46546445
Patient uncooperative 22.20 9.77 10 123903 147 46562002
Tooth hypoplasia 21.85 9.77 8 123905 66 46562083
Hypoxic-ischaemic encephalopathy 21.85 9.77 39 123874 4034 46558115
Osteonecrosis of jaw 21.82 9.77 36 123877 34366 46527783
Multiple sclerosis 21.67 9.77 126 123787 24665 46537484
Wheezing 21.66 9.77 71 123842 53315 46508834
Psychogenic seizure 21.65 9.77 21 123892 1189 46560960
Ascites 21.64 9.77 40 123873 36544 46525605
Victim of sexual abuse 21.46 9.77 15 123898 533 46561616
Ventricular dyskinesia 21.44 9.77 10 123903 160 46561989
Rhesus antigen positive 21.39 9.77 9 123904 111 46562038
Injection site swelling 21.37 9.77 47 123866 40280 46521869
Influenza 21.26 9.77 144 123769 89126 46473023
Urine osmolarity increased 21.25 9.77 9 123904 113 46562036
Loss of personal independence in daily activities 21.21 9.77 79 123834 57104 46505045
Bladder dilatation 21.20 9.77 17 123896 746 46561403
Gastrointestinal disorder 21.01 9.77 84 123829 59492 46502657
Alcohol use 20.94 9.77 29 123884 2413 46559736
Affective disorder 20.76 9.77 42 123871 4773 46557376
Hospitalisation 20.73 9.77 92 123821 63293 46498856
Tardive dyskinesia 20.61 9.77 55 123858 7488 46554661
Apnoea 20.55 9.77 54 123859 7285 46554864
Blood creatine phosphokinase increased 20.52 9.77 135 123778 27589 46534560
Abnormal dreams 20.49 9.77 67 123846 10212 46551937
Suspected counterfeit product 20.46 9.77 12 123901 313 46561836
Blood pressure systolic increased 20.31 9.77 28 123885 28759 46533390
Leukopenia 20.13 9.77 103 123810 68240 46493909
Urine sodium increased 20.08 9.77 8 123905 85 46562064
Palmar-plantar erythrodysaesthesia syndrome 20.00 9.77 15 123898 20436 46541713
Newborn persistent pulmonary hypertension 19.99 9.77 8 123905 86 46562063
Abortion spontaneous 19.89 9.77 55 123858 43591 46518558
Panic disorder 19.87 9.77 29 123884 2532 46559617
Hepatic necrosis 19.71 9.77 45 123868 5556 46556593
Drug level increased 19.69 9.77 99 123814 18342 46543807
Medication error 19.64 9.77 145 123768 30766 46531383
Melaena 19.60 9.77 27 123886 27745 46534404
Thinking abnormal 19.59 9.77 64 123849 9750 46552399
Fungal infection 19.56 9.77 30 123883 29490 46532659
Hyperthermia 19.49 9.77 56 123857 7958 46554191
Hip arthroplasty 19.42 9.77 12 123901 18100 46544049
Cortisol increased 19.41 9.77 12 123901 345 46561804
Colitis 19.40 9.77 44 123869 37303 46524846
Cerebrospinal fluid leakage 19.37 9.77 17 123896 846 46561303
Sensory disturbance 19.32 9.77 74 123839 12193 46549956
Feeling drunk 19.31 9.77 36 123877 3851 46558298
Illogical thinking 19.31 9.77 7 123906 56 46562093
Neonatal complications of substance abuse 19.21 9.77 5 123908 10 46562139
Inadequate analgesia 19.11 9.77 30 123883 2794 46559355
Wrong rate 19.10 9.77 7 123906 58 46562091
Restless legs syndrome 19.04 9.77 88 123825 15755 46546394
Cellulitis 19.01 9.77 109 123804 70179 46491970
Spleen congestion 18.96 9.77 9 123904 150 46561999
Helicobacter infection 18.94 9.77 4 123909 11732 46550417
Oral discomfort 18.93 9.77 55 123858 7863 46554286
Alpha 1 microglobulin increased 18.89 9.77 5 123908 11 46562138
Primitive reflex test positive 18.89 9.77 5 123908 11 46562138
Bezoar 18.86 9.77 21 123892 1398 46560751
Enterochromaffin cell hyperplasia 18.79 9.77 7 123906 61 46562088
Cataract 18.70 9.77 60 123853 45355 46516794
Oedema 18.68 9.77 103 123810 66968 46495181
Electrocardiogram QRS complex shortened 18.67 9.77 12 123901 370 46561779
White blood cell count decreased 18.65 9.77 199 123714 112032 46450117
Periorbital swelling 18.62 9.77 20 123893 1278 46560871
Treatment noncompliance 18.62 9.77 139 123774 29592 46532557
Product use issue 18.61 9.77 161 123752 94483 46467666
Balance disorder 18.61 9.77 257 123656 64264 46497885
Pleurothotonus 18.59 9.77 19 123894 1146 46561003
Hypergastrinaemia 18.57 9.77 8 123905 105 46562044
Carcinoid tumour of the stomach 18.54 9.77 9 123904 158 46561991
Paraesthesia 18.52 9.77 425 123488 117012 46445137
Injection site bruising 18.50 9.77 42 123871 35594 46526555
Discomfort 18.29 9.77 63 123850 46607 46515542
Blood pressure fluctuation 18.27 9.77 33 123880 30415 46531734
Defect conduction intraventricular 18.17 9.77 8 123905 111 46562038
Personality disorder 18.11 9.77 31 123882 3102 46559047
H1N1 influenza 18.09 9.77 21 123892 1463 46560686
Injection site warmth 17.99 9.77 7 123906 13765 46548384
Blood immunoglobulin M decreased 17.98 9.77 15 123898 696 46561453
Terminal dribbling 17.89 9.77 6 123907 37 46562112
Therapeutic response decreased 17.76 9.77 57 123856 43088 46519061
Urinary incontinence 17.65 9.77 133 123780 28397 46533752
Red blood cell sedimentation rate increased 17.45 9.77 21 123892 22868 46539281
Tongue movement disturbance 17.35 9.77 9 123904 183 46561966
Neuropathy peripheral 17.27 9.77 156 123757 90737 46471412
Sudden death 17.22 9.77 60 123853 9444 46552705
Borderline personality disorder 17.15 9.77 15 123898 743 46561406
Rash pruritic 17.12 9.77 60 123853 44155 46517994
Marchiafava-Bignami disease 17.09 9.77 5 123908 18 46562131
Skin ulcer 17.06 9.77 38 123875 32420 46529729
Movement disorder 16.98 9.77 89 123824 16760 46545389
Blood osmolarity decreased 16.98 9.77 15 123898 753 46561396
Euphoric mood 16.93 9.77 36 123877 4236 46557913
Pulmonary fibrosis 16.90 9.77 17 123896 20075 46542074
Diastolic hypotension 16.88 9.77 7 123906 83 46562066
Dyspraxia 16.80 9.77 9 123904 196 46561953
Reversible airways obstruction 16.76 9.77 13 123900 543 46561606
Gallbladder cholesterolosis 16.76 9.77 15 123898 766 46561383
Thymus disorder 16.76 9.77 9 123904 197 46561952
Stupor 16.74 9.77 32 123881 3488 46558661
Road traffic accident 16.72 9.77 114 123799 23577 46538572
Congenital central nervous system anomaly 16.61 9.77 11 123902 357 46561792
Femur fracture 16.58 9.77 47 123866 36950 46525199
Victim of chemical submission 16.51 9.77 10 123903 277 46561872
Illness anxiety disorder 16.50 9.77 8 123905 140 46562009
Basal cell carcinoma 16.48 9.77 18 123895 20469 46541680
Aphasia 16.47 9.77 131 123782 28436 46533713
Clostridium difficile colitis 16.42 9.77 15 123898 18538 46543611
Craniosynostosis 16.40 9.77 8 123905 142 46562007
Coordination abnormal 16.39 9.77 65 123848 10884 46551265
Cor pulmonale acute 16.29 9.77 11 123902 369 46561780
Pain in jaw 16.29 9.77 50 123863 38322 46523827
Lower respiratory tract infection 16.23 9.77 83 123830 55006 46507143
Cardiac death 16.22 9.77 13 123900 570 46561579
Cholinergic syndrome 16.21 9.77 11 123902 372 46561777
Acute myeloid leukaemia 16.18 9.77 11 123902 15767 46546382
Hostility 16.14 9.77 19 123894 1343 46560806
Somnambulism 16.13 9.77 39 123874 4998 46557151
Septic shock 16.07 9.77 89 123824 57804 46504345
Drug hypersensitivity 16.00 9.77 509 123404 243316 46318833
Hypokinesia 15.98 9.77 66 123847 11256 46550893
Base excess 15.95 9.77 5 123908 24 46562125
Tension 15.91 9.77 28 123885 2864 46559285
Accidental poisoning 15.79 9.77 13 123900 592 46561557
Hyperacusis 15.78 9.77 22 123891 1842 46560307
Paralysis 15.75 9.77 55 123858 8666 46553483
Hallucination, visual 15.73 9.77 91 123822 17782 46544367
Neurosis 15.71 9.77 10 123903 303 46561846
Bone erosion 15.70 9.77 3 123910 9440 46552709
Lack of spontaneous speech 15.68 9.77 8 123905 157 46561992
Atrioventricular septal defect 15.65 9.77 9 123904 226 46561923
Chronic kidney disease 15.46 9.77 56 123857 40815 46521334
Neutrophil count decreased 15.46 9.77 61 123852 43365 46518784
Hand deformity 15.43 9.77 44 123869 34530 46527619
Hypercapnic coma 15.37 9.77 8 123905 164 46561985
Hypotensive crisis 15.36 9.77 4 123909 8 46562141
Somatic symptom disorder 15.35 9.77 22 123891 1890 46560259
Liver function test increased 15.31 9.77 23 123890 22803 46539346
Poor sucking reflex 15.24 9.77 8 123905 167 46561982
Sinus tachycardia 15.17 9.77 104 123809 21545 46540604
Incontinence 15.13 9.77 59 123854 9803 46552346
Haematochezia 15.11 9.77 50 123863 37443 46524706
Thyroid adenoma 15.07 9.77 8 123905 171 46561978
Infective pulmonary exacerbation of cystic fibrosis 14.95 9.77 5 123908 10802 46551347
Morbid thoughts 14.89 9.77 12 123901 530 46561619
Cyclothymic disorder 14.88 9.77 5 123908 31 46562118
Drug-device interaction 14.87 9.77 6 123907 66 46562083
Angioedema 14.82 9.77 54 123859 39288 46522861
Disinhibition 14.80 9.77 15 123898 896 46561253
Adverse drug reaction 14.74 9.77 64 123849 44298 46517851
Epistaxis 14.68 9.77 105 123808 64200 46497949
Sensory loss 14.67 9.77 46 123867 6856 46555293
Benzodiazepine drug level increased 14.62 9.77 8 123905 182 46561967
Clonus 14.60 9.77 33 123880 4047 46558102
Psychiatric symptom 14.59 9.77 35 123878 4462 46557687
Logorrhoea 14.51 9.77 24 123889 2335 46559814
Cyanosis 14.50 9.77 82 123831 15889 46546260
Lupus hepatitis 14.49 9.77 5 123908 34 46562115
Vestibular disorder 14.47 9.77 18 123895 1348 46560801
Porphyria 14.42 9.77 7 123906 123 46562026
Sudden cardiac death 14.41 9.77 23 123890 2172 46559977
Extravascular haemolysis 14.37 9.77 5 123908 35 46562114
Facial nerve disorder 14.35 9.77 12 123901 559 46561590
Gait deviation 14.33 9.77 6 123907 73 46562076
Swollen tongue 14.18 9.77 129 123784 29103 46533046
Toxicologic test abnormal 14.17 9.77 13 123900 686 46561463
Emotional distress 14.14 9.77 134 123779 30573 46531576
Bundle branch block right 14.05 9.77 36 123877 4783 46557366
Foetal death 13.98 9.77 53 123860 8690 46553459
Bruxism 13.83 9.77 27 123886 2990 46559159
Substance use disorder 13.79 9.77 5 123908 40 46562109
Suspected suicide 13.77 9.77 35 123878 4626 46557523
Needle track marks 13.76 9.77 4 123909 14 46562135
Muscle tightness 13.71 9.77 59 123854 10246 46551903
Congenital hand malformation 13.71 9.77 9 123904 288 46561861
Psoriatic arthropathy 13.66 9.77 50 123863 36329 46525820
Perforation bile duct 13.54 9.77 4 123909 15 46562134
Clostridium difficile infection 13.51 9.77 29 123884 25074 46537075
Behaviour disorder 13.50 9.77 21 123892 1940 46560209
Persistent depressive disorder 13.49 9.77 15 123898 997 46561152
Cardiac arrest neonatal 13.45 9.77 6 123907 86 46562063
Blood bicarbonate decreased 13.44 9.77 26 123887 2859 46559290
Nodule 13.36 9.77 13 123900 15592 46546557
Oxygen saturation abnormal 13.29 9.77 25 123888 2693 46559456
Eosinophilia 13.25 9.77 19 123894 19198 46542951
Renal impairment 13.12 9.77 130 123783 74242 46487907
Abscess sterile 13.09 9.77 5 123908 47 46562102
Apgar score low 13.02 9.77 12 123901 637 46561512
Head titubation 12.99 9.77 12 123901 639 46561510
Anaphylactic reaction 12.98 9.77 85 123828 53027 46509122
Sputum discoloured 12.98 9.77 9 123904 12769 46549380
Metastases to liver 12.88 9.77 20 123893 19565 46542584
Galactorrhoea 12.81 9.77 30 123883 3767 46558382
Judgement impaired 12.74 9.77 12 123901 655 46561494
Exposure to unspecified agent 12.73 9.77 3 123910 3 46562146
Tongue discolouration 12.71 9.77 26 123887 2978 46559171
Oculogyric crisis 12.67 9.77 16 123897 1217 46560932
Hepatic steatosis 12.65 9.77 108 123805 23934 46538215
Delirium tremens 12.64 9.77 6 123907 100 46562049
Gastrointestinal motility disorder 12.59 9.77 33 123880 4445 46557704
Prescription drug used without a prescription 12.55 9.77 17 123896 1385 46560764
Social avoidant behaviour 12.52 9.77 25 123888 2814 46559335
Intellectual disability 12.51 9.77 12 123901 670 46561479
Body mass index decreased 12.51 9.77 9 123904 335 46561814
Muscle twitching 12.45 9.77 74 123839 14598 46547551
Hip fracture 12.45 9.77 33 123880 26523 46535626
Incoherent 12.43 9.77 33 123880 4479 46557670
Feeling jittery 12.40 9.77 60 123853 10948 46551201
Adrenal insufficiency 12.36 9.77 10 123903 13114 46549035
Waxy flexibility 12.28 9.77 6 123907 107 46562042
Frontotemporal dementia 12.27 9.77 8 123905 253 46561896
Eczema eyelids 12.23 9.77 6 123907 108 46562041
Sensation of foreign body 12.22 9.77 30 123883 3881 46558268
COVID-19 12.19 9.77 19 123894 18556 46543593
Tuberculosis 12.17 9.77 6 123907 10259 46551890
Foetal exposure during pregnancy 12.15 9.77 130 123783 30617 46531532
Thrombosis 12.11 9.77 93 123820 55976 46506173
Hemiparesis 12.10 9.77 93 123820 19976 46542173
Skin reaction 12.09 9.77 7 123906 10939 46551210
Right ventricular failure 12.02 9.77 15 123898 16078 46546071
Mental impairment 12.01 9.77 65 123848 12391 46549758
Blood pressure diastolic decreased 11.98 9.77 12 123901 14199 46547950
Bacteraemia 11.92 9.77 12 123901 14167 46547982
Poverty of speech 11.91 9.77 8 123905 266 46561883
Encephalopathy 11.90 9.77 139 123774 33450 46528699
Foaming at mouth 11.83 9.77 15 123898 1145 46561004
Unmasking of previously unidentified disease 11.81 9.77 12 123901 719 46561430
Rhinorrhoea 11.79 9.77 76 123837 47589 46514560
Colitis ulcerative 11.77 9.77 18 123895 17714 46544435
Blood loss anaemia 11.77 9.77 4 123909 8553 46553596
Ovarian cyst 11.75 9.77 12 123901 14075 46548074
Calcium deficiency 11.74 9.77 13 123900 860 46561289
Myelosuppression 11.69 9.77 3 123910 7700 46554449
Hepatic enzyme increased 11.65 9.77 150 123763 81637 46480512
Localised infection 11.60 9.77 29 123884 23772 46538377
Victim of homicide 11.58 9.77 5 123908 66 46562083
Adverse event 11.55 9.77 49 123864 34135 46528014
Bradycardia neonatal 11.54 9.77 11 123902 609 46561540
Pulmonary congestion 11.53 9.77 73 123840 14726 46547423
Congenital nystagmus 11.52 9.77 3 123910 6 46562143
Osteoporosis 11.51 9.77 62 123851 40546 46521603
Obsessive-compulsive disorder 11.50 9.77 26 123887 3189 46558960
Peritoneal perforation 11.48 9.77 6 123907 124 46562025
Radial nerve palsy 11.48 9.77 9 123904 382 46561767
Emotional poverty 11.47 9.77 8 123905 283 46561866
Hepatotoxicity 11.45 9.77 109 123804 24900 46537249
Regressive behaviour 11.45 9.77 5 123908 68 46562081
Progressive supranuclear palsy 11.45 9.77 5 123908 68 46562081
Hypotension 11.33 9.77 739 123174 231850 46330299
Purpura senile 11.32 9.77 11 123902 624 46561525
Illusion 11.32 9.77 14 123899 1042 46561107
Brain injury 11.29 9.77 39 123874 6111 46556038
Brain oedema 11.29 9.77 64 123849 12414 46549735
Tenosynovitis 11.26 9.77 3 123910 7512 46554637
Acute myocardial infarction 11.26 9.77 45 123868 31879 46530270
Hypoventilation 11.26 9.77 30 123883 4080 46558069
Nystagmus 11.22 9.77 37 123876 5662 46556487
Partial seizures 11.22 9.77 34 123879 4976 46557173
Clonic convulsion 11.20 9.77 11 123902 632 46561517
Central nervous system stimulation 11.14 9.77 4 123909 31 46562118
Poor quality sleep 11.12 9.77 74 123839 15179 46546970
Potentiating drug interaction 11.12 9.77 29 123884 3894 46558255
Pericardial effusion 11.04 9.77 33 123880 25510 46536639
Hereditary angioedema 11.03 9.77 36 123877 5480 46556669
International normalised ratio increased 10.97 9.77 76 123837 46807 46515342
Formication 10.96 9.77 29 123884 3927 46558222
Eye irritation 10.90 9.77 17 123896 16597 46545552
Lung disorder 10.74 9.77 69 123844 43235 46518914
Rash maculo-papular 10.67 9.77 38 123875 27836 46534313
Brief psychotic disorder with marked stressors 10.66 9.77 5 123908 81 46562068
Hypertonia 10.66 9.77 31 123882 4435 46557714
Alcohol abuse 10.65 9.77 20 123893 2152 46559997
Schizoaffective disorder 10.63 9.77 16 123897 1436 46560713
Stubbornness 10.60 9.77 7 123906 226 46561923
Osteonecrosis 10.60 9.77 34 123879 25710 46536439
Resorption bone increased 10.60 9.77 14 123899 1113 46561036
Duodenal ulcer 10.60 9.77 3 123910 7215 46554934
Acute psychosis 10.59 9.77 19 123894 1973 46560176
Feeling abnormal 10.57 9.77 419 123494 124641 46437508
Rhabdomyolysis 10.53 9.77 163 123750 41746 46520403
Hyperchloraemia 10.51 9.77 11 123902 682 46561467
Choreoathetosis 10.51 9.77 9 123904 433 46561716
Impaired healing 10.46 9.77 56 123857 36687 46525462
Ventricular arrhythmia 10.43 9.77 26 123887 3395 46558754
Hyperchromic anaemia 10.43 9.77 4 123909 38 46562111
Brachial plexus injury 10.43 9.77 3 123910 10 46562139
Vital capacity decreased 10.41 9.77 10 123903 559 46561590
Electrocardiogram QRS complex prolonged 10.40 9.77 35 123878 5414 46556735
Petit mal epilepsy 10.38 9.77 25 123888 3195 46558954
Alcoholism 10.35 9.77 20 123893 2198 46559951
Otospondylomegaepiphyseal dysplasia 10.29 9.77 5 123908 88 46562061
Aspartate aminotransferase increased 10.25 9.77 147 123766 78553 46483596
Breathing-related sleep disorder 10.24 9.77 5 123908 89 46562060
Transfusion 10.23 9.77 12 123901 13219 46548930
Automatic bladder 10.19 9.77 5 123908 90 46562059
Delusion of reference 10.19 9.77 5 123908 90 46562059
Diverticulitis 10.18 9.77 49 123864 32990 46529159
Coating in mouth 10.18 9.77 6 123907 158 46561991
Pulmonary hypertension 10.17 9.77 55 123858 35938 46526211
Fibromyalgia 10.15 9.77 56 123857 36407 46525742
Ischaemic stroke 10.14 9.77 18 123895 16704 46545445
Pneumonitis 10.06 9.77 40 123873 28380 46533769
Labelled drug-food interaction issue 10.01 9.77 3 123910 12 46562137
Rectal haemorrhage 9.98 9.77 60 123853 38195 46523954
Proteinuria 9.88 9.77 18 123895 16535 46545614
Moaning 9.84 9.77 11 123902 735 46561414
Haemoptysis 9.83 9.77 36 123877 26153 46535996
Congenital scoliosis 9.82 9.77 3 123910 13 46562136
Myofascial pain syndrome 9.80 9.77 18 123895 1903 46560246
Hyporeflexia 9.80 9.77 18 123895 1904 46560245

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
Toxicity to various agents 3121.09 10.62 3184 85551 173999 29689744
Drug abuse 2959.66 10.62 2222 86513 79850 29783893
Overdose 829.54 10.62 1130 87605 83207 29780536
Coma 780.93 10.62 768 87967 39681 29824062
Intentional overdose 670.76 10.62 716 88019 40765 29822978
Completed suicide 648.39 10.62 1101 87634 98391 29765352
Drug dependence 628.46 10.62 514 88221 20781 29842962
Respiratory arrest 517.45 10.62 530 88205 28728 29835015
Poisoning 517.35 10.62 356 88379 11026 29852717
Somnolence 483.45 10.62 955 87780 95808 29767935
Suicide attempt 469.46 10.62 561 88174 36136 29827607
Intentional product misuse 379.21 10.62 490 88245 34177 29829566
Accidental overdose 313.83 10.62 326 88409 17949 29845794
Poisoning deliberate 280.88 10.62 190 88545 5714 29858029
Substance abuse 273.17 10.62 200 88535 6840 29856903
Agitation 272.35 10.62 536 88199 53537 29810206
Respiratory depression 268.68 10.62 243 88492 11260 29852483
Drug withdrawal syndrome 250.13 10.62 301 88434 19508 29844235
Aggression 247.07 10.62 414 88321 36493 29827250
Miosis 221.51 10.62 184 88551 7592 29856151
Intentional self-injury 219.13 10.62 234 88501 13298 29850445
Sedation 211.97 10.62 252 88483 16121 29847622
Bradypnoea 206.83 10.62 105 88630 1816 29861927
Suicidal ideation 197.71 10.62 371 88364 35743 29828000
Diarrhoea 196.43 10.62 438 88297 333665 29530078
Cardiac arrest 196.20 10.62 663 88072 92187 29771556
Cardio-respiratory arrest 190.24 10.62 481 88254 56825 29806918
Febrile neutropenia 185.74 10.62 44 88691 106649 29757094
Sopor 153.65 10.62 176 88559 10815 29852928
Pneumonia aspiration 153.35 10.62 343 88392 37437 29826306
Withdrawal syndrome 150.32 10.62 176 88559 11074 29852669
Neuroleptic malignant syndrome 145.70 10.62 209 88526 16086 29847657
Depressed level of consciousness 142.97 10.62 336 88399 37886 29825857
Drug abuser 141.96 10.62 112 88623 4289 29859454
Anxiety 138.40 10.62 580 88155 89291 29774452
Asphyxia 137.38 10.62 120 88615 5305 29858438
Anaemia 129.97 10.62 263 88472 207729 29656014
Acute kidney injury 127.25 10.62 403 88332 273439 29590304
Drug use disorder 125.37 10.62 92 88643 3156 29860587
Housebound 120.53 10.62 38 88697 163 29863580
Pneumonia 116.81 10.62 552 88183 333754 29529989
Drug interaction 116.67 10.62 998 87737 198570 29665173
Prescription drug used without a prescription 110.29 10.62 60 88675 1202 29862541
Coma scale abnormal 106.93 10.62 85 88650 3291 29860452
Accidental death 106.32 10.62 70 88665 2009 29861734
Visceral congestion 103.13 10.62 44 88691 500 29863243
Seizure 99.29 10.62 563 88172 97912 29765831
Dyspnoea 99.22 10.62 581 88154 332714 29531029
Malignant neoplasm progression 99.11 10.62 45 88690 72242 29791501
Rash 98.71 10.62 269 88466 191620 29672123
Psychotic disorder 97.17 10.62 204 88531 21311 29842432
Salivary hypersecretion 97.15 10.62 116 88619 7450 29856293
Thrombocytopenia 96.42 10.62 161 88574 136883 29726860
Loss of consciousness 92.34 10.62 472 88263 78903 29784840
Restlessness 91.47 10.62 205 88530 22394 29841349
Cardiac failure congestive 91.12 10.62 70 88665 84337 29779406
Pancytopenia 83.86 10.62 77 88658 84975 29778768
Atrial fibrillation 80.78 10.62 122 88613 108002 29755741
Sepsis 80.77 10.62 198 88537 146197 29717546
Drug screen positive 79.92 10.62 81 88654 4326 29859417
Dysarthria 79.18 10.62 234 88501 30256 29833487
Abnormal behaviour 77.67 10.62 208 88527 25415 29838328
Interstitial lung disease 77.17 10.62 41 88694 60156 29803587
Pulmonary congestion 77.09 10.62 134 88601 12153 29851590
Disease progression 76.76 10.62 74 88661 79800 29783943
Disturbance in attention 74.65 10.62 187 88548 21942 29841801
Dystonia 74.41 10.62 116 88619 9611 29854132
Cough 74.05 10.62 164 88571 125478 29738265
Nausea 72.02 10.62 550 88185 296407 29567336
Extrapyramidal disorder 70.22 10.62 119 88616 10574 29853169
Fatigue 69.98 10.62 611 88124 320062 29543681
Delirium 67.00 10.62 268 88467 40363 29823380
Rheumatoid arthritis 65.93 10.62 20 88715 41177 29822566
Status epilepticus 65.91 10.62 118 88617 10954 29852789
Bradyphrenia 65.05 10.62 69 88666 3888 29859855
Logorrhoea 65.04 10.62 52 88683 2030 29861713
Brain oedema 64.87 10.62 125 88610 12273 29851470
Pyrexia 63.82 10.62 562 88173 293927 29569816
Altered state of consciousness 63.73 10.62 165 88570 19754 29843989
Electrocardiogram QT prolonged 63.67 10.62 242 88493 35593 29828150
Alcohol poisoning 62.52 10.62 66 88669 3698 29860045
Hypothermia 62.20 10.62 106 88629 9461 29854282
Plasma cell myeloma 62.05 10.62 41 88694 53421 29810322
Arthralgia 62.05 10.62 201 88534 135590 29728153
Confusional state 60.99 10.62 639 88096 134195 29729548
Exposure via ingestion 58.68 10.62 54 88681 2557 29861186
Depression 57.87 10.62 462 88273 89975 29773768
Haemoglobin decreased 57.78 10.62 161 88574 113937 29749806
Mood swings 57.02 10.62 90 88645 7536 29856207
Mydriasis 55.20 10.62 79 88656 6064 29857679
Drug withdrawal convulsions 54.40 10.62 37 88698 1122 29862621
Platelet count decreased 54.30 10.62 149 88586 105980 29757763
Echolalia 53.92 10.62 21 88714 185 29863558
Paranoia 53.64 10.62 103 88632 10085 29853658
Suicidal behaviour 53.52 10.62 39 88696 1323 29862420
Infusion related reaction 52.91 10.62 27 88708 40537 29823206
Decreased appetite 51.83 10.62 248 88487 149662 29714081
Thinking abnormal 51.74 10.62 71 88664 5240 29858503
Antipsychotic drug level increased 51.68 10.62 55 88680 3111 29860632
Peripheral swelling 51.55 10.62 63 88672 61011 29802732
Insomnia 51.34 10.62 461 88274 92875 29770868
Aspiration 51.11 10.62 103 88632 10448 29853295
Dehydration 50.95 10.62 191 88544 123348 29740395
Psychomotor hyperactivity 50.69 10.62 89 88646 8135 29855608
Renal impairment 50.29 10.62 109 88626 84075 29779668
Pulmonary oedema 50.04 10.62 260 88475 43715 29820028
Delusion 49.90 10.62 110 88625 11879 29851864
Panic attack 49.74 10.62 91 88644 8590 29855153
Cytomegalovirus infection 49.41 10.62 6 88729 23668 29840075
Irritability 48.91 10.62 165 88570 22885 29840858
International normalised ratio increased 48.49 10.62 42 88693 47697 29816046
Joint swelling 48.05 10.62 41 88694 46905 29816838
Weight decreased 48.01 10.62 257 88478 150664 29713079
Tension 47.88 10.62 39 88696 1564 29862179
Schizophrenia 47.06 10.62 91 88644 8957 29854786
Nystagmus 46.87 10.62 61 88674 4277 29859466
Pruritus 46.65 10.62 186 88549 118018 29745725
Psychotic symptom 46.61 10.62 34 88701 1155 29862588
Myocardial infarction 46.28 10.62 203 88532 125422 29738321
Pleural effusion 45.83 10.62 94 88641 73972 29789771
Self-injurious ideation 45.66 10.62 38 88697 1571 29862172
Dyspnoea exertional 45.59 10.62 24 88711 35406 29828337
Tremor 45.49 10.62 380 88355 74983 29788760
Alcohol abuse 45.42 10.62 67 88668 5286 29858457
Generalised tonic-clonic seizure 45.11 10.62 144 88591 19407 29844336
Toxicologic test abnormal 45.02 10.62 26 88709 587 29863156
Mucosal inflammation 44.97 10.62 17 88718 30477 29833266
Akathisia 44.58 10.62 70 88665 5834 29857909
Asthenia 44.52 10.62 430 88305 220860 29642883
Cerebrovascular accident 44.35 10.62 115 88620 83362 29780381
Abdominal pain 43.69 10.62 230 88505 135424 29728319
Product dose omission issue 43.68 10.62 133 88602 91498 29772245
Serotonin syndrome 43.33 10.62 134 88601 17757 29845986
Tachycardia 43.02 10.62 369 88366 73370 29790373
Gastrointestinal haemorrhage 42.78 10.62 117 88618 83329 29780414
Nightmare 42.78 10.62 104 88631 11972 29851771
Postmortem blood drug level abnormal 41.84 10.62 18 88717 209 29863534
Anger 41.81 10.62 98 88637 11022 29852721
Hypertonia 41.78 10.62 58 88677 4327 29859416
Disorientation 41.61 10.62 194 88541 31224 29832519
General physical health deterioration 40.88 10.62 155 88580 99789 29763954
Mental impairment 40.76 10.62 87 88648 9190 29854553
Infection 40.37 10.62 109 88626 77965 29785778
Catatonia 40.35 10.62 57 88678 4323 29859420
Hyperhidrosis 40.33 10.62 338 88397 66752 29796991
Epistaxis 40.28 10.62 59 88676 52922 29810821
Renal failure 39.68 10.62 222 88513 128744 29734999
Oedema peripheral 39.59 10.62 170 88565 105662 29758081
Sinus tachycardia 39.30 10.62 118 88617 15386 29848357
Nasopharyngitis 38.73 10.62 72 88663 58777 29804966
Drug ineffective 37.65 10.62 747 87988 339640 29524103
Hallucination, auditory 37.60 10.62 87 88648 9702 29854041
Arteriosclerosis coronary artery 37.22 10.62 94 88641 11082 29852661
Off label use 36.72 10.62 519 88216 248771 29614972
Acute myeloid leukaemia 36.52 10.62 5 88730 18001 29845742
Stomatitis 36.42 10.62 34 88701 37245 29826498
Memory impairment 36.38 10.62 211 88524 36963 29826780
Pneumonitis 36.21 10.62 18 88717 27436 29836307
Self-medication 35.94 10.62 39 88696 2255 29861488
Cardiac failure 35.66 10.62 127 88608 83291 29780452
Drug diversion 35.47 10.62 26 88709 890 29862853
Colitis 35.26 10.62 24 88711 30796 29832947
Ascites 34.81 10.62 33 88702 35888 29827855
Sudden death 34.74 10.62 113 88622 15379 29848364
Product use in unapproved indication 34.37 10.62 108 88627 73585 29790158
Pneumocystis jirovecii pneumonia 34.15 10.62 5 88730 17115 29846628
Drug intolerance 33.88 10.62 51 88684 45240 29818503
Hypotonia 33.86 10.62 68 88667 6880 29856863
Psychomotor skills impaired 33.40 10.62 35 88700 1944 29861799
Drug withdrawal syndrome neonatal 33.30 10.62 44 88691 3131 29860612
Fluid overload 32.93 10.62 8 88727 19084 29844659
Prostate cancer 32.68 10.62 15 88720 23942 29839801
Emotional disorder 32.53 10.62 56 88679 5038 29858705
Poor quality sleep 31.92 10.62 68 88667 7173 29856570
COVID-19 31.81 10.62 7 88728 17871 29845872
Angioedema 31.70 10.62 33 88702 34351 29829392
Chills 31.68 10.62 109 88626 72229 29791514
Agoraphobia 31.45 10.62 15 88720 225 29863518
Unresponsive to stimuli 31.29 10.62 158 88577 26261 29837482
Acute myocardial infarction 31.22 10.62 69 88666 52870 29810873
Neutropenia 31.06 10.62 238 88497 128302 29735441
Rhabdomyolysis 30.92 10.62 306 88429 63274 29800469
Hypoventilation 30.33 10.62 41 88694 2982 29860761
Homicide 30.30 10.62 25 88710 1021 29862722
Haematuria 30.26 10.62 54 88681 44780 29818963
Sleep disorder 30.13 10.62 148 88587 24331 29839412
Blood creatinine increased 29.91 10.62 154 88581 91221 29772522
Erythema 29.82 10.62 123 88612 77328 29786415
Coordination abnormal 29.25 10.62 66 88669 7239 29856504
Hypoxic-ischaemic encephalopathy 29.24 10.62 51 88684 4636 29859107
Muscle spasticity 29.23 10.62 54 88681 5134 29858609
Bladder dilatation 29.22 10.62 27 88708 1285 29862458
Inadequate analgesia 29.13 10.62 38 88697 2670 29861073
Psoriasis 28.86 10.62 51 88684 42455 29821288
Blepharospasm 28.65 10.62 23 88712 903 29862840
Palmar-plantar erythrodysaesthesia syndrome 28.18 10.62 5 88730 14865 29848878
Bone marrow failure 28.12 10.62 28 88707 29757 29833986
Ataxia 27.89 10.62 86 88649 11376 29852367
Acute psychosis 27.84 10.62 31 88704 1845 29861898
Accident 27.51 10.62 43 88692 3570 29860173
Victim of chemical submission 27.43 10.62 9 88726 45 29863698
Facial spasm 27.20 10.62 13 88722 196 29863547
Myelodysplastic syndrome 26.81 10.62 11 88724 18767 29844976
Mental disorder 26.54 10.62 94 88641 13355 29850388
Anterograde amnesia 26.29 10.62 12 88723 162 29863581
Chronic kidney disease 26.05 10.62 45 88690 37793 29825950
Bronchopulmonary aspergillosis 25.91 10.62 3 88732 12281 29851462
Cerebral haemorrhage 25.61 10.62 36 88699 32851 29830892
Chest discomfort 25.43 10.62 61 88674 45419 29818324
Haematochezia 25.15 10.62 39 88696 34183 29829560
Oral discharge 24.96 10.62 11 88724 136 29863607
Dependence 24.95 10.62 24 88711 1202 29862541
Osteonecrosis of jaw 24.86 10.62 12 88723 18606 29845137
Epilepsy 24.86 10.62 122 88613 20047 29843696
Suicide threat 24.64 10.62 7 88728 19 29863724
Anaphylactic reaction 24.52 10.62 28 88707 27954 29835789
Sexual abuse 24.00 10.62 11 88724 150 29863593
Blood pressure fluctuation 23.81 10.62 11 88724 17492 29846251
Electrolyte imbalance 23.79 10.62 3 88732 11497 29852246
Neutrophil count increased 23.60 10.62 99 88636 15224 29848519
Necrotising colitis 23.53 10.62 21 88714 955 29862788
Disinhibition 23.49 10.62 29 88706 1928 29861815
Dizziness 23.23 10.62 422 88313 194487 29669256
Depressed mood 23.17 10.62 106 88629 16923 29846820
Muscle rigidity 23.14 10.62 75 88660 10186 29853557
Asthma 23.14 10.62 45 88690 36129 29827614
Behaviour disorder 23.13 10.62 32 88703 2380 29861363
Tumour lysis syndrome 23.02 10.62 5 88730 12880 29850863
Persecutory delusion 22.97 10.62 30 88705 2110 29861633
Clostridium difficile infection 22.94 10.62 9 88726 15774 29847969
Nervousness 22.93 10.62 82 88653 11706 29852037
Alcohol interaction 22.80 10.62 34 88701 2708 29861035
Needle track marks 22.39 10.62 6 88729 12 29863731
Coronary artery disease 22.38 10.62 74 88661 49638 29814105
Patient restraint 22.20 10.62 9 88726 89 29863654
Herpes zoster 22.12 10.62 34 88701 29909 29833834
Pruritus genital 22.11 10.62 15 88720 453 29863290
Basilar migraine 22.07 10.62 6 88729 13 29863730
Hospitalisation 22.06 10.62 63 88672 44256 29819487
Stiff person syndrome 21.97 10.62 10 88725 134 29863609
Learning disorder 21.88 10.62 15 88720 461 29863282
Opisthotonus 21.82 10.62 14 88721 384 29863359
Medication error 21.80 10.62 121 88614 20851 29842892
Mania 21.64 10.62 68 88667 9086 29854657
Pulmonary fibrosis 21.59 10.62 10 88725 15880 29847863
Libido disorder 21.55 10.62 12 88723 252 29863491
Treatment noncompliance 21.33 10.62 138 88597 25115 29838628
Personal relationship issue 21.21 10.62 10 88725 146 29863597
Productive cough 21.19 10.62 35 88700 29918 29833825
Diet refusal 21.08 10.62 13 88722 332 29863411
Brain injury 20.97 10.62 49 88686 5499 29858244
Hallucinations, mixed 20.95 10.62 31 88704 2452 29861291
White blood cell count decreased 20.94 10.62 154 88581 83793 29779950
Abnormal dreams 20.79 10.62 62 88673 8053 29855690
Clumsiness 20.72 10.62 23 88712 1364 29862379
Impaired self-care 20.66 10.62 19 88716 899 29862844
Melaena 20.19 10.62 41 88694 32396 29831347
Schizoaffective disorder 20.17 10.62 20 88715 1040 29862703
Hyperkalaemia 20.07 10.62 114 88621 65896 29797847
Spleen congestion 20.06 10.62 13 88722 363 29863380
Injection site pain 20.01 10.62 37 88698 30273 29833470
Crystalluria 19.84 10.62 13 88722 370 29863373
Fluid retention 19.83 10.62 27 88708 24971 29838772
Pupillary disorder 19.76 10.62 11 88724 231 29863512
Homicidal ideation 19.71 10.62 30 88705 2433 29861310
Hyperbilirubinaemia 19.64 10.62 13 88722 16929 29846814
Urticaria 19.62 10.62 89 88646 54517 29809226
Portal tract inflammation 19.56 10.62 8 88727 81 29863662
Penis injury 19.55 10.62 11 88724 236 29863507
Illusion 19.47 10.62 17 88718 751 29862992
Claustrophobia 19.46 10.62 11 88724 238 29863505
Reflexes abnormal 19.41 10.62 12 88723 308 29863435
Blood pressure increased 19.38 10.62 129 88606 71799 29791944
Neuropathy peripheral 19.19 10.62 126 88609 70349 29793394
Hypocalcaemia 19.16 10.62 21 88714 21355 29842388
Postmortem blood drug level increased 19.11 10.62 9 88726 131 29863612
Subacute endocarditis 19.01 10.62 7 88728 52 29863691
Thrombosis 18.91 10.62 63 88672 42168 29821575
Hypomagnesaemia 18.89 10.62 13 88722 16585 29847158
Accidental poisoning 18.83 10.62 14 88721 490 29863253
Fatty liver alcoholic 18.82 10.62 8 88727 90 29863653
Pancreatitis 18.81 10.62 51 88684 36439 29827304
Cerebral congestion 18.80 10.62 6 88729 27 29863716
Somnambulism 18.80 10.62 34 88701 3180 29860563
Septic shock 18.73 10.62 111 88624 63496 29800247
Bradykinesia 18.68 10.62 34 88701 3196 29860547
Pulmonary contusion 18.67 10.62 7 88728 55 29863688
Vestibular disorder 18.63 10.62 17 88718 796 29862947
Rebound psychosis 18.46 10.62 9 88726 142 29863601
Affective disorder 18.34 10.62 33 88702 3075 29860668
Rash pruritic 18.29 10.62 24 88711 22548 29841195
Persistent depressive disorder 18.26 10.62 11 88724 269 29863474
Tearfulness 18.12 10.62 23 88712 1573 29862170
Parkinsonism 18.11 10.62 55 88680 7214 29856529
Peritonitis 18.08 10.62 22 88713 21353 29842390
Cardiomegaly 18.05 10.62 88 88647 14421 29849322
Priapism 18.04 10.62 42 88693 4701 29859042
Respiratory acidosis 17.99 10.62 39 88696 4163 29859580
Blunted affect 17.98 10.62 11 88724 277 29863466
Lymphoma 17.93 10.62 4 88731 10117 29853626
Arthropathy 17.88 10.62 21 88714 20706 29843037
Congestive hepatopathy 17.87 10.62 25 88710 1879 29861864
Tubulointerstitial nephritis 17.85 10.62 16 88719 17875 29845868
Hepatic function abnormal 17.82 10.62 64 88671 41881 29821862
Victim of crime 17.80 10.62 11 88724 282 29863461
Arthritis 17.74 10.62 28 88707 24373 29839370
Lymphadenopathy 17.70 10.62 28 88707 24348 29839395
Antipsychotic drug level decreased 17.68 10.62 17 88718 851 29862892
Osmolar gap abnormal 17.67 10.62 6 88729 34 29863709
Transplant rejection 17.65 10.62 3 88732 9203 29854540
Deep vein thrombosis 17.59 10.62 106 88629 60395 29803348
Pain in extremity 17.42 10.62 226 88509 109995 29753748
Drug detoxification 17.38 10.62 10 88725 224 29863519
Femoral nerve palsy 17.38 10.62 6 88729 36 29863707
Peritonitis bacterial 17.36 10.62 6 88729 11372 29852371
Obsessive thoughts 17.30 10.62 15 88720 656 29863087
Hostility 17.18 10.62 17 88718 882 29862861
Apnoea 17.17 10.62 49 88686 6209 29857534
Rectal haemorrhage 17.14 10.62 50 88685 34889 29828854
Neuromuscular toxicity 17.11 10.62 6 88729 38 29863705
Metastases to liver 17.10 10.62 7 88728 11958 29851785
Amnesia 17.05 10.62 127 88608 24194 29839549
Full blood count decreased 16.98 10.62 13 88722 15704 29848039
Blood pressure systolic increased 16.97 10.62 12 88723 15098 29848645
Stupor 16.97 10.62 31 88704 2922 29860821
White blood cell count increased 16.94 10.62 186 88549 39487 29824256
Bradycardia neonatal 16.91 10.62 17 88718 899 29862844
Colitis ulcerative 16.83 10.62 11 88724 14423 29849320
Road traffic accident 16.76 10.62 97 88638 16974 29846769
Bacteraemia 16.65 10.62 13 88722 15547 29848196
Myocarditis 16.46 10.62 66 88669 9945 29853798
Encephalitis toxic 16.37 10.62 8 88727 127 29863616
Skin ulcer 16.37 10.62 19 88716 18830 29844913
Myocardial depression 16.36 10.62 6 88729 44 29863699
Apathy 16.33 10.62 48 88687 6184 29857559
Inappropriate antidiuretic hormone secretion 16.21 10.62 72 88663 11350 29852393
Opiates positive 16.20 10.62 10 88725 256 29863487
Angina pectoris 16.17 10.62 40 88695 29478 29834265
Movement disorder 16.13 10.62 65 88670 9818 29853925
Multiple organ dysfunction syndrome 16.05 10.62 116 88619 63371 29800372
Depressive symptom 16.04 10.62 22 88713 1623 29862120
Cataract 15.93 10.62 25 88710 21810 29841933
Neoplasm progression 15.83 10.62 18 88717 18005 29845738
Nephrolithiasis 15.75 10.62 31 88704 24779 29838964
Stereotypy 15.67 10.62 13 88722 535 29863208
Selective mutism 15.59 10.62 6 88729 51 29863692
Myofascial pain syndrome 15.57 10.62 11 88724 355 29863388
Haemorrhage intracranial 15.53 10.62 13 88722 15019 29848724
Leukopenia 15.49 10.62 100 88635 56059 29807684
Contraindicated product administered 15.36 10.62 17 88718 17214 29846529
Blood ketone body increased 15.36 10.62 11 88724 363 29863380
Basal cell carcinoma 15.29 10.62 15 88720 16053 29847690
Cellulitis 15.21 10.62 79 88656 46705 29817038
Sensory integrative dysfunction 15.08 10.62 5 88730 26 29863717
Bezoar 15.06 10.62 16 88719 903 29862840
Panic disorder 15.06 10.62 18 88717 1157 29862586
Aspartate aminotransferase increased 15.03 10.62 118 88617 63304 29800439
Porphyria acute 14.98 10.62 7 88728 100 29863643
Liver disorder 14.97 10.62 42 88693 29680 29834063
Blood creatine phosphokinase increased 14.96 10.62 197 88538 43651 29820092
Breech presentation 14.94 10.62 8 88727 155 29863588
Emotional disorder of childhood 14.92 10.62 5 88730 27 29863716
Post-traumatic stress disorder 14.85 10.62 21 88714 1594 29862149
Drug tolerance increased 14.77 10.62 11 88724 386 29863357
Tuberculosis 14.70 10.62 3 88732 8074 29855669
Treatment failure 14.67 10.62 53 88682 34626 29829117
Hangover 14.62 10.62 17 88718 1061 29862682
Staring 14.60 10.62 20 88715 1473 29862270
Hepatocellular injury 14.59 10.62 127 88608 25344 29838399
Diabetes mellitus 14.58 10.62 69 88666 41796 29821947
Mobility decreased 14.43 10.62 35 88700 25964 29837779
Penile haemorrhage 14.41 10.62 13 88722 600 29863143
Graft versus host disease 14.40 10.62 6 88729 10144 29853599
Analgesic drug level above therapeutic 14.39 10.62 9 88726 236 29863507
Anticonvulsant drug level increased 14.38 10.62 20 88715 1495 29862248
Incorrect route of product administration 14.34 10.62 69 88666 11246 29852497
Terminal insomnia 14.34 10.62 11 88724 404 29863339
Oedema 14.32 10.62 72 88663 42921 29820822
Prostatic specific antigen increased 14.20 10.62 9 88726 11995 29851748
Hanging 14.16 10.62 7 88728 114 29863629
Inappropriate schedule of product administration 14.12 10.62 65 88670 39663 29824080
Vascular stenosis 14.12 10.62 8 88727 174 29863569
Drug level increased 14.12 10.62 98 88637 18256 29845487
Drug tolerance 14.11 10.62 24 88711 2138 29861605
Diffuse large B-cell lymphoma 14.09 10.62 3 88732 7838 29855905
Delirium tremens 14.00 10.62 12 88723 517 29863226
Rhinorrhoea 13.99 10.62 25 88710 20729 29843014
Abdominal discomfort 13.91 10.62 86 88649 48705 29815038
Flushing 13.90 10.62 43 88692 29449 29834294
Chemical poisoning 13.89 10.62 7 88728 119 29863624
Forearm fracture 13.85 10.62 6 88729 71 29863672
Alcoholism 13.84 10.62 31 88704 3383 29860360
Herbal interaction 13.80 10.62 10 88725 336 29863407
Alcohol intolerance 13.77 10.62 11 88724 429 29863314
Accident at work 13.72 10.62 13 88722 639 29863104
Hepatic enzyme increased 13.64 10.62 52 88683 33442 29830301
Abdominal pain upper 13.63 10.62 119 88616 62432 29801311
Sciatic nerve neuropathy 13.63 10.62 6 88729 74 29863669
Eosinophilic myocarditis 13.61 10.62 11 88724 436 29863307
Pathogen resistance 13.60 10.62 4 88731 8406 29855337
Wrong dose 13.60 10.62 10 88725 344 29863399
Haemorrhagic fever 13.59 10.62 5 88730 37 29863706
Upper gastrointestinal haemorrhage 13.57 10.62 28 88707 22000 29841743
Respiratory failure 13.56 10.62 213 88522 100429 29763314
Haemophagocytic lymphohistiocytosis 13.56 10.62 6 88729 9785 29853958
Erectile dysfunction 13.54 10.62 96 88639 18006 29845737
Squamous cell carcinoma of skin 13.53 10.62 5 88730 9090 29854653
Colon cancer 13.51 10.62 4 88731 8368 29855375
Hyperglycaemia 13.48 10.62 56 88679 35144 29828599
Hypoglycaemia 13.45 10.62 92 88643 50889 29812854
Social anxiety disorder 13.44 10.62 9 88726 266 29863477
Congenital pulmonary valve atresia 13.41 10.62 6 88729 77 29863666
Cytopenia 13.22 10.62 4 88731 8252 29855491
Pneumoconiosis 13.20 10.62 9 88726 274 29863469
Antipsychotic drug level above therapeutic 13.07 10.62 16 88719 1054 29862689
Hepatotoxicity 13.02 10.62 21 88714 18124 29845619
Physical assault 13.01 10.62 17 88718 1196 29862547
Respiratory rate decreased 12.99 10.62 21 88714 1794 29861949
Adverse drug reaction 12.97 10.62 31 88704 23114 29840629
Haematocrit decreased 12.93 10.62 47 88688 30652 29833091
Bladder hypertrophy 12.92 10.62 9 88726 284 29863459
Ex-drug abuser 12.92 10.62 8 88727 206 29863537
Electrocardiogram J wave 12.91 10.62 4 88731 16 29863727
Suspected suicide attempt 12.83 10.62 7 88728 141 29863602
Hypertension 12.83 10.62 268 88467 121086 29742657
Febrile bone marrow aplasia 12.83 10.62 4 88731 8093 29855650
Crime 12.82 10.62 6 88729 86 29863657
Chronic obstructive pulmonary disease 12.79 10.62 82 88653 46044 29817699
Bone pain 12.76 10.62 23 88712 19003 29844740
Cerebral infarction 12.75 10.62 38 88697 26335 29837408
Social avoidant behaviour 12.75 10.62 27 88708 2836 29860907
Haemorrhage 12.73 10.62 82 88653 45997 29817746
Affect lability 12.71 10.62 30 88705 3388 29860355
Diverticulitis 12.70 10.62 20 88715 17425 29846318
Laboratory test abnormal 12.69 10.62 20 88715 17422 29846321
Dry skin 12.64 10.62 30 88705 22424 29841319
Stress at work 12.61 10.62 7 88728 146 29863597
Reaction to excipient 12.60 10.62 10 88725 386 29863357
Hepatic steatosis 12.59 10.62 81 88654 14712 29849031
Hypersensitivity 12.58 10.62 101 88634 53927 29809816
Therapeutic response decreased 12.57 10.62 34 88701 24315 29839428
Nephropathy toxic 12.55 10.62 8 88727 10631 29853112
Physical abuse 12.53 10.62 4 88731 18 29863725
Atrial septal defect 12.51 10.62 46 88689 6655 29857088
Erythrosis 12.46 10.62 5 88730 48 29863695
Potentiating drug interaction 12.45 10.62 36 88699 4595 29859148
Blood bilirubin increased 12.40 10.62 61 88674 36575 29827168
Cytokine release syndrome 12.38 10.62 7 88728 9926 29853817
Syncope 12.36 10.62 177 88558 84726 29779017
Slow speech 12.32 10.62 15 88720 983 29862760
Dissociation 12.30 10.62 16 88719 1121 29862622
Xanthelasma 12.29 10.62 6 88729 95 29863648
Hepatitis cholestatic 12.27 10.62 4 88731 7868 29855875
Bradycardia 12.26 10.62 267 88468 65259 29798484
Alanine aminotransferase increased 12.21 10.62 151 88584 74125 29789618
Muscular weakness 12.19 10.62 125 88610 63520 29800223
Cerebrovascular stenosis 12.18 10.62 6 88729 97 29863646
Sluggishness 12.14 10.62 28 88707 3115 29860628
Sciatic nerve injury 12.12 10.62 6 88729 98 29863645
Swelling 12.12 10.62 60 88675 35915 29827828
Family stress 12.08 10.62 7 88728 159 29863584
Cerebellar syndrome 12.07 10.62 22 88713 2070 29861673
Muscle twitching 12.03 10.62 52 88683 8103 29855640
Immune reconstitution inflammatory syndrome 11.95 10.62 6 88729 9095 29854648
Inflammation 11.95 10.62 30 88705 21996 29841747
Speech disorder 11.92 10.62 118 88617 24394 29839349
Disturbance in social behaviour 11.89 10.62 18 88717 1453 29862290
Autism spectrum disorder 11.84 10.62 17 88718 1308 29862435
Metastases to bone 11.76 10.62 7 88728 9651 29854092
Nephrotic syndrome 11.65 10.62 3 88732 6882 29856861
Stab wound 11.63 10.62 7 88728 171 29863572
Mucosal erosion 11.59 10.62 13 88722 780 29862963
Delusional disorder, unspecified type 11.58 10.62 13 88722 781 29862962
Dyskinesia 11.55 10.62 107 88628 21727 29842016
Cardiac disorder 11.54 10.62 70 88665 39823 29823920
Neoplasm malignant 11.53 10.62 22 88713 17792 29845951
Blood alcohol increased 11.50 10.62 14 88721 917 29862826
Blood glucose decreased 11.50 10.62 13 88722 13040 29850703
Blood urine 11.39 10.62 10 88725 445 29863298
Kidney transplant rejection 11.38 10.62 4 88731 7505 29856238
Oral pain 11.34 10.62 7 88728 9462 29854281
Abdominal distension 11.32 10.62 84 88651 45625 29818118
Prescription form tampering 11.30 10.62 11 88724 559 29863184
Transfusion 11.27 10.62 4 88731 7457 29856286
Laryngeal disorder 11.27 10.62 6 88729 115 29863628
Carbon monoxide poisoning 11.22 10.62 6 88729 116 29863627
Binge drinking 11.20 10.62 3 88732 6 29863737
Skull fractured base 11.17 10.62 7 88728 184 29863559
Posterior reversible encephalopathy syndrome 11.05 10.62 6 88729 8701 29855042
Accommodation disorder 11.04 10.62 7 88728 188 29863555
Subdural haematoma 10.96 10.62 25 88710 18947 29844796
CSF white blood cell count positive 10.94 10.62 4 88731 29 29863714
Antisocial behaviour 10.94 10.62 8 88727 273 29863470
Blood alkaline phosphatase increased 10.90 10.62 52 88683 31435 29832308
Coma scale 10.88 10.62 3 88732 7 29863736
Thrombotic microangiopathy 10.83 10.62 6 88729 8604 29855139
Wheezing 10.77 10.62 51 88684 30887 29832856
Flat affect 10.72 10.62 13 88722 848 29862895
Small for dates baby 10.70 10.62 27 88708 3181 29860562
Drug hypersensitivity 10.63 10.62 141 88594 68378 29795365

Pharmacologic Action:

SourceCodeDescription
ATC N05BA01 NERVOUS SYSTEM
PSYCHOLEPTICS
ANXIOLYTICS
Benzodiazepine derivatives
FDA CS M0002356 Benzodiazepines
MeSH PA D000759 Adjuvants, Anesthesia
MeSH PA D000777 Anesthetics
MeSH PA D018686 Anesthetics, Intravenous
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D000927 Anticonvulsants
MeSH PA D000932 Antiemetics
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D018682 GABA Agents
MeSH PA D018757 GABA Modulators
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D006993 Hypnotics and Sedatives
MeSH PA D009125 Muscle Relaxants, Central
MeSH PA D009465 Neuromuscular Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D014149 Tranquilizing Agents
FDA EPC N0000175694 Benzodiazepine
CHEBI has role CHEBI:35474 minor tranquilisers
CHEBI has role CHEBI:35623 antiepileptic
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:35717 sedatives
CHEBI has role CHEBI:78298 environmental contaminants

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Alcohol withdrawal delirium indication 8635005
Anxiety indication 48694002
Sedation indication 72641008
Tetanus indication 76902006 DOID:11338
Epilepsy indication 84757009 DOID:1826
Alcohol withdrawal syndrome indication 191480000
Spasticity indication 221360009
Status epilepticus indication 230456007 DOID:1824
Induce Anterograde Amnesia indication
Preoperative Anxiety indication
Panic disorder off-label use 371631005 DOID:594
Cocaine-Associated Acute Ischemic Heart Disease off-label use
Disorder of lung contraindication 19829001 DOID:850
Alcohol intoxication contraindication 25702006
Depressive disorder contraindication 35489007
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Substance abuse contraindication 66214007
Sleep apnea contraindication 73430006 DOID:0050847
Decreased respiratory function contraindication 80954004
Open-angle glaucoma contraindication 84494001 DOID:1067
Myasthenia gravis contraindication 91637004 DOID:437
Hypoalbuminemia contraindication 119247004
Disease of liver contraindication 235856003 DOID:409
Pregnancy, function contraindication 289908002
Severe chronic obstructive pulmonary disease contraindication 313299006
Angle-closure glaucoma contraindication 392291006 DOID:13550
Breastfeeding (mother) contraindication 413712001

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.06 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG/SPRAY VALTOCO NEURELIS INC N211635 Jan. 10, 2020 RX SPRAY NULLSAL Jan. 10, 2023 NEW PRODUCT
5MG/SPRAY VALTOCO NEURELIS INC N211635 Jan. 10, 2020 RX SPRAY NULLSAL Jan. 10, 2023 NEW PRODUCT
7.5MG/SPRAY VALTOCO NEURELIS INC N211635 Jan. 10, 2020 RX SPRAY NULLSAL Jan. 10, 2023 NEW PRODUCT
10MG/SPRAY VALTOCO NEURELIS INC N211635 Jan. 10, 2020 RX SPRAY NULLSAL Jan. 10, 2027 INDICATED FOR THE ACUTE TX OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E. SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT’S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 6 YEARS OF AGE AND OLDER
5MG/SPRAY VALTOCO NEURELIS INC N211635 Jan. 10, 2020 RX SPRAY NULLSAL Jan. 10, 2027 INDICATED FOR THE ACUTE TX OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E. SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT’S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 6 YEARS OF AGE AND OLDER
7.5MG/SPRAY VALTOCO NEURELIS INC N211635 Jan. 10, 2020 RX SPRAY NULLSAL Jan. 10, 2027 INDICATED FOR THE ACUTE TX OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E. SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT’S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 6 YEARS OF AGE AND OLDER

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
GABA-A receptor alpha-1/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR EC50 7.14 WOMBAT-PK CHEMBL
GABA-A receptor alpha-1/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 7.85 WOMBAT-PK CHEMBL
GABA-A receptor alpha-2/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 7.70 WOMBAT-PK CHEMBL
GABA A receptor alpha-3/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 7.94 WOMBAT-PK CHEMBL
GABA-A receptor alpha-5/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 7.96 WOMBAT-PK CHEMBL
GABA A receptor alpha-5/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 8.00 WOMBAT-PK CHEMBL
GABA A receptor alpha-5/beta-2/gamma-3 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 7.20 WOMBAT-PK CHEMBL
GABA A receptor alpha-5/beta-3/gamma-3 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 7.20 WOMBAT-PK CHEMBL
GABA-A receptor alpha-1/beta-2/gamma-3 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 6.71 WOMBAT-PK CHEMBL
GABA A receptor alpha-3/beta-2/gamma-3 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 6.67 WOMBAT-PK CHEMBL
GABA-A receptor alpha-3/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 7.65 WOMBAT-PK CHEMBL
Cytochrome P450 3A4 Enzyme Ki 4.42 WOMBAT-PK
Alpha-1A adrenergic receptor GPCR ALLOSTERIC MODULATOR Ki 4.10 IUPHAR
Gamma-aminobutyric acid receptor subunit alpha-5 Ion channel Kd 7.64 CHEMBL
Adenosine receptor A3 GPCR IC50 7.92 CHEMBL
Translocator protein Membrane receptor Kd 6.67 CHEMBL
Cholinesterase Enzyme Ki 7.37 CHEMBL
GABA-A receptor; anion channel Ion channel Ki 8.54 CHEMBL
GABA-A receptor; anion channel Ion channel Ki 4.07 CHEMBL
GABA A receptor alpha-2/beta-2/gamma-2 Ion channel Ki 7.70 CHEMBL
Gamma-aminobutyric acid receptor subunit alpha-2 Ion channel Ki 7.82 CHEMBL
Thyrotropin-releasing hormone receptor GPCR ANTAGONIST Ki 5.15 IUPHAR
GABA-A receptor; alpha-1/beta-2/gamma-2 Ion channel Ki 7.92 CHEMBL
Gamma-aminobutyric acid receptor subunit alpha-1 Ion channel Ki 7.96 CHEMBL
Fatty acid-binding protein, liver Unclassified Ki 6.27 CHEMBL
Gamma-aminobutyric acid receptor subunit alpha-5 Ion channel Ki 8.01 CHEMBL
GABA-A receptor; anion channel Ion channel Ki 8 CHEMBL
GABA A receptor alpha-3/beta-2/gamma-2 Ion channel Ki 7.86 CHEMBL
Acetylcholinesterase Enzyme Ki 4.89 CHEMBL
GABA A receptor alpha-5/beta-3/gamma-2 Ion channel Ki 7.96 CHEMBL
GABA A receptor alpha-6/beta-2/gamma-2 Ion channel Ki 8.68 CHEMBL

External reference:

IDSource
4017796 VUID
N0000146157 NUI
D00293 KEGG_DRUG
4017796 VANDF
C0012010 UMLSCUI
CHEBI:49575 CHEBI
DZP PDB_CHEM_ID
CHEMBL12 ChEMBL_ID
DB00829 DRUGBANK_ID
D003975 MESH_DESCRIPTOR_UI
3016 PUBCHEM_CID
3364 IUPHAR_LIGAND_ID
1295 INN_ID
Q3JTX2Q7TU UNII
202472 RXNORM
3018 MMSL
4573 MMSL
894 MMSL
d00148 MMSL
001461 NDDF
387264003 SNOMEDCT_US
48546005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Diazepam Intensol HUMAN PRESCRIPTION DRUG LABEL 1 0054-3185 SOLUTION, CONCENTRATE 5 mg ORAL ANDA 24 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0054-3188 SOLUTION 5 mg ORAL ANDA 26 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0093-6137 GEL 2.50 mg RECTAL NDA authorized generic 21 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0093-6138 GEL 10 mg RECTAL NDA authorized generic 21 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0093-6139 GEL 20 mg RECTAL NDA authorized generic 21 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0121-0905 SOLUTION 5 mg ORAL ANDA 24 sections
Valium HUMAN PRESCRIPTION DRUG LABEL 1 0140-0004 TABLET 2 mg ORAL NDA 28 sections
Valium HUMAN PRESCRIPTION DRUG LABEL 1 0140-0005 TABLET 5 mg ORAL NDA 28 sections
Valium HUMAN PRESCRIPTION DRUG LABEL 1 0140-0006 TABLET 10 mg ORAL NDA 28 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0172-3925 TABLET 2 mg ORAL ANDA 16 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0172-3926 TABLET 5 mg ORAL ANDA 16 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0172-3927 TABLET 10 mg ORAL ANDA 16 sections
Diastat HUMAN PRESCRIPTION DRUG LABEL 1 0187-0658 GEL 10 mg RECTAL NDA 19 sections
Diastat HUMAN PRESCRIPTION DRUG LABEL 1 0187-0659 GEL 20 mg RECTAL NDA 19 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0378-0271 TABLET 2 mg ORAL ANDA 28 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0378-0345 TABLET 5 mg ORAL ANDA 28 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0378-0477 TABLET 10 mg ORAL ANDA 28 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-1273 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 21 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-1273 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 21 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-3213 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 20 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-3213 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 20 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0527-1767 SOLUTION 5 mg ORAL ANDA 21 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0527-1768 SOLUTION, CONCENTRATE 5 mg ORAL ANDA 21 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0615-7799 TABLET 5 mg ORAL ANDA 16 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0615-7800 TABLET 10 mg ORAL ANDA 14 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 0904-5880 TABLET 5 mg ORAL ANDA 26 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 10544-161 TABLET 10 mg ORAL ANDA 26 sections
Diazepam HUMAN PRESCRIPTION DRUG LABEL 1 11704-600 INJECTION 10 mg INTRAMUSCULAR NDA 22 sections
DIAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 12634-529 TABLET 5 mg ORAL ANDA 14 sections
DIAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 12634-698 TABLET 10 mg ORAL ANDA 14 sections