midazolam 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
diazepam derivatives 1802 59467-70-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • buccolam
  • midazolam
  • mezolam
  • midazolam hydrochloride
  • midazolam HCl
A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.
  • Molecular weight: 325.77
  • Formula: C18H13ClFN3
  • CLOGP: 3.42
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 0
  • TPSA: 30.18
  • ALOGS: -4.52
  • ROTB: 1
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
5 mg N
15 mg O
15 mg P
10 mg SL

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 10.30 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 5.60 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.26 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 44 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.10 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.30 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) 3.10 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.515 Moderate 0.73
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.456 Moderate 0.73
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 68.391 10^-6 cm/s Moderate 0.73
dh-clint Dog hepatocyte intrinsic clearance 91.622 uL/min/10^6 cells Moderate 0.73
dppb Dog plasma protein binding (% unbound) 3.840 % Moderate 0.73
fcs-ppb Fetal calf serum protein binding (% unbound) 8.590 % Moderate 0.73
herg hERG pIC50 5.158 pIC50 Moderate 0.73
hh-clint Human hepatocyte intrinsic clearance 48.865 uL/min/10^6 cells Moderate 0.73
hlm-clint Human liver microsomal intrinsic clearance 272.270 uL/min/mg protein Moderate 0.73
hppb Human plasma protein binding (% unbound) 3.010 % Moderate 0.73
kinase-safety-class ACVR2B,GRK2,PDK1,PDK2,PDK4 5
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.617 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.397 Moderate 0.73
mh-clint Mouse hepatocyte intrinsic clearance 246.604 Moderate 0.73
mppb Mouse plasma protein binding (% unbound) 4.960 Moderate 0.73
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.321 Moderate 0.73
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 5.950 % Moderate 0.73
rat-kpuu-brain Rat brain Kpuu 0.912 % High 1
rh-clint Rat hepatocyte intrinsic clearance 282.488 uL/min/10^6 cells Moderate 0.73
rh-fuinc Rat hepatocyte fraction unbound in incubation 44.270 % Moderate 0.73
rppb Rat plasma protein binding (% unbound) 3.960 % Moderate 0.73
solubility-dd Solubility at pH 7.4 in DMSO 87.700 uM Moderate 0.73

Approvals:

DateAgencyCompanyOrphan
Sept. 25, 2020 PMDA TAKEDA PHARMACEUTICAL COMPANY LIMITED
Dec. 20, 1985 FDA
Sept. 4, 2011 EMA Laboratorios Lesvi S.L.

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
Status epilepticus 437.06 15.35 200 41375 18674 90568198
Multiple-drug resistance 403.46 15.35 147 41428 7629 90579243
Hypotension 392.05 15.35 604 40971 324793 90262079
Cardiac arrest 391.60 15.35 349 41226 104586 90482286
Serotonin syndrome 389.74 15.35 233 41342 37654 90549218
Drug ineffective 361.22 15.35 1415 40160 1382883 89203989
Drug ineffective for unapproved indication 279.45 15.35 237 41338 66407 90520465
Drug interaction 266.06 15.35 464 41111 275989 90310883
Propofol infusion syndrome 257.45 15.35 69 41506 1270 90585602
Female genital tract fistula 251.60 15.35 135 41440 17733 90569139
Vaginal flatulence 243.51 15.35 118 41457 12520 90574352
Proctitis 242.47 15.35 125 41450 15134 90571738
Anaphylactic reaction 233.35 15.35 242 41333 87282 90499590
Radiculopathy 222.54 15.35 126 41449 18379 90568493
Seizure 211.57 15.35 303 41272 152326 90434546
Myoglobin urine present 208.50 15.35 52 41523 710 90586162
Toxic encephalopathy 200.77 15.35 92 41483 8607 90578265
Vaginal discharge 195.68 15.35 118 41457 19346 90567526
Oral candidiasis 190.88 15.35 146 41429 35309 90551563
Chronic sinusitis 181.11 15.35 121 41454 23681 90563191
Joint swelling 181.06 15.35 13 41562 503287 90083585
Alopecia 180.38 15.35 12 41563 495059 90091813
Fatigue 176.02 15.35 163 41412 1153860 89433012
Agitation 174.28 15.35 183 41392 66915 90519957
Colitis 171.48 15.35 185 41390 69757 90517115
Metabolic acidosis 166.74 15.35 164 41411 55512 90531360
Off label use 159.73 15.35 954 40621 1101298 89485574
Abdominal discomfort 159.02 15.35 17 41558 477311 90109561
Multiple organ dysfunction syndrome 157.53 15.35 175 41400 68161 90518711
Arthropathy 153.26 15.35 3 41572 366239 90220633
Swelling 153.08 15.35 10 41565 419048 90167824
Respiratory failure 152.29 15.35 227 41348 118191 90468681
Generalised tonic-clonic seizure 150.09 15.35 126 41449 34777 90552095
Frequent bowel movements 147.34 15.35 155 41420 56780 90530092
Respiratory acidosis 145.03 15.35 72 41503 8047 90578825
Tachycardia 144.13 15.35 259 41316 157414 90429458
Colitis ulcerative 141.78 15.35 156 41419 60110 90526762
Bradycardia 141.15 15.35 183 41392 83664 90503208
Rheumatoid arthritis 140.72 15.35 6 41569 362608 90224264
Systemic lupus erythematosus 140.40 15.35 6 41569 361890 90224982
Partial seizures 131.51 15.35 65 41510 7195 90579677
Diabetes insipidus 131.26 15.35 51 41524 3161 90583711
Respiratory depression 130.23 15.35 84 41491 15491 90571381
Unresponsive to stimuli 128.73 15.35 120 41455 38001 90548871
Myoclonus 128.20 15.35 90 41485 19078 90567794
Oxygen saturation decreased 125.44 15.35 197 41378 107286 90479586
Arthralgia 124.37 15.35 105 41470 778417 89808455
Anaphylactic shock 123.44 15.35 108 41467 31509 90555363
Paraesthesia oral 123.32 15.35 108 41467 31551 90555321
Circulatory collapse 117.73 15.35 95 41480 24809 90562063
Unwanted awareness during anaesthesia 117.31 15.35 29 41546 381 90586491
Peripheral swelling 116.25 15.35 24 41551 413082 90173790
Mitochondrial DNA mutation 114.12 15.35 29 41546 429 90586443
Drug intolerance 112.36 15.35 33 41542 447558 90139314
Intra-abdominal pressure increased 111.21 15.35 26 41549 265 90586607
Blood creatine phosphokinase increased 110.85 15.35 105 41470 33918 90552954
Labile blood pressure 109.93 15.35 39 41536 1871 90585001
Shock 109.74 15.35 97 41478 28681 90558191
Amylase increased 109.65 15.35 57 41518 7015 90579857
Encephalopathy 107.12 15.35 119 41456 46325 90540547
Macular degeneration 106.57 15.35 108 41467 37862 90549010
Haematochezia 102.90 15.35 144 41431 70769 90516103
Toxicity to various agents 102.03 15.35 327 41248 287519 90299353
Procedural pain 101.22 15.35 99 41476 33261 90553611
Nasopharyngitis 100.38 15.35 31 41544 407073 90179799
Weight increased 99.21 15.35 34 41541 417893 90168979
Pain in extremity 96.49 15.35 43 41532 450486 90136386
Rectal haemorrhage 95.61 15.35 151 41424 82593 90504279
Apnoea 94.42 15.35 57 41518 9357 90577515
Contraindicated product administered 93.41 15.35 17 41558 320122 90266750
Anaesthetic complication neurological 91.47 15.35 27 41548 714 90586158
Impaired healing 90.40 15.35 4 41571 234195 90352677
Anticholinergic syndrome 89.38 15.35 37 41538 2706 90584166
Ventricular hypokinesia 88.45 15.35 45 41530 5296 90581576
Systemic inflammatory response syndrome 88.27 15.35 48 41527 6468 90580404
Delayed recovery from anaesthesia 86.78 15.35 28 41547 1002 90585870
Hepatic enzyme increased 84.48 15.35 30 41545 360706 90226166
Hypoxia 83.47 15.35 132 41443 72267 90514605
Sinusitis 81.25 15.35 28 41547 343060 90243812
Troponin increased 81.08 15.35 59 41516 13222 90573650
Renal ischaemia 81.04 15.35 24 41551 642 90586230
Asthma 79.60 15.35 9 41566 242151 90344721
Necrosis ischaemic 79.57 15.35 26 41549 969 90585903
Acute respiratory distress syndrome 79.42 15.35 81 41494 28605 90558267
Pulseless electrical activity 79.21 15.35 50 41525 8882 90577990
Mydriasis 78.98 15.35 61 41514 14951 90571921
Lower respiratory tract infection 78.30 15.35 11 41564 250648 90336224
Myocardial depression 77.85 15.35 23 41552 610 90586262
Depressed level of consciousness 77.50 15.35 128 41447 72656 90514216
Hepatic ischaemia 77.15 15.35 24 41551 761 90586111
Altered state of consciousness 76.53 15.35 83 41492 31449 90555423
PCO2 increased 76.29 15.35 27 41548 1286 90585586
Haemodynamic instability 75.90 15.35 54 41521 11685 90575187
Electroencephalogram abnormal 75.16 15.35 37 41538 4059 90582813
Oxygen saturation abnormal 73.55 15.35 37 41538 4251 90582621
Blood gases abnormal 73.38 15.35 24 41551 897 90585975
Blood cholesterol increased 72.92 15.35 6 41569 208006 90378866
Irritable bowel syndrome 72.68 15.35 6 41569 207442 90379430
CSF oligoclonal band present 71.64 15.35 20 41555 431 90586441
Pneumatosis 70.78 15.35 20 41555 451 90586421
Therapy interrupted 68.62 15.35 99 41476 50009 90536863
Diarrhoea 68.37 15.35 213 41362 938977 89647895
Cardiogenic shock 67.57 15.35 69 41506 24399 90562473
Stomatitis 67.52 15.35 21 41554 274677 90312195
Musculoskeletal stiffness 67.15 15.35 26 41549 296506 90290366
Sleep disorder 65.99 15.35 7 41568 198023 90388849
Paradoxical drug reaction 65.93 15.35 38 41537 5728 90581144
Contusion 65.82 15.35 17 41558 251199 90335673
Bronchospasm 65.72 15.35 63 41512 20646 90566226
Hepatic failure 65.71 15.35 86 41489 39642 90547230
Mobility decreased 65.64 15.35 17 41558 250717 90336155
Blood pH decreased 65.20 15.35 29 41546 2529 90584343
Muscle injury 65.08 15.35 4 41571 176650 90410222
Electrocardiogram QRS complex prolonged 64.82 15.35 41 41534 7307 90579565
Blood lactate dehydrogenase increased 64.23 15.35 69 41506 25863 90561009
Fall 64.15 15.35 76 41499 481734 90105138
Disseminated intravascular coagulation 63.63 15.35 63 41512 21475 90565397
Intentional overdose 63.60 15.35 136 41439 93698 90493174
Gene mutation 63.60 15.35 27 41548 2103 90584769
Stress cardiomyopathy 63.23 15.35 51 41524 13304 90573568
Upper airway obstruction 62.93 15.35 22 41553 1010 90585862
Intestinal ischaemia 62.42 15.35 43 41532 8840 90578032
Discomfort 62.21 15.35 24 41551 274311 90312561
PO2 increased 62.11 15.35 21 41554 871 90586001
Abdominal pain upper 60.56 15.35 39 41536 332635 90254237
Blood potassium increased 60.02 15.35 60 41515 20689 90566183
Overdose 58.39 15.35 182 41393 157527 90429345
Ill-defined disorder 58 15.35 8 41567 184883 90401989
Vocal cord dysfunction 57.72 15.35 20 41555 894 90585978
Pruritus 57.69 15.35 100 41475 541425 90045447
Brain oedema 57.28 15.35 54 41521 17331 90569541
Musculoskeletal pain 57.19 15.35 6 41569 171245 90415627
Blister 56.68 15.35 23 41552 254975 90331897
Blood lactic acid increased 55.88 15.35 40 41535 8738 90578134
Pleocytosis 55.81 15.35 20 41555 988 90585884
Arthritis 55.52 15.35 6 41569 167309 90419563
Premature delivery 55.15 15.35 78 41497 38684 90548188
Rash 54.78 15.35 185 41390 795915 89790957
Anuria 54.61 15.35 49 41526 14769 90572103
Hypersensitivity 54.06 15.35 78 41497 454599 90132273
Sinus tachycardia 53.94 15.35 66 41509 28447 90558425
No adverse event 53.72 15.35 105 41470 67877 90518995
Local anaesthetic systemic toxicity 53.66 15.35 28 41547 3472 90583400
Wrong product administered 53.61 15.35 37 41538 7628 90579244
Procedural hypotension 53.55 15.35 22 41553 1578 90585294
Anaesthetic complication 53.54 15.35 25 41550 2440 90584432
Dry mouth 53.17 15.35 10 41565 184049 90402823
Hypoaesthesia 53.00 15.35 40 41535 314170 90272702
Gastrointestinal disorder 52.58 15.35 26 41549 256661 90330211
Wheezing 52.06 15.35 22 41553 238058 90348814
Arrhythmia 51.31 15.35 79 41496 42253 90544619
Cardio-respiratory arrest 49.26 15.35 97 41478 63043 90523829
Respiratory arrest 48.83 15.35 68 41507 33243 90553629
Pain 48.61 15.35 264 41311 996077 89590795
Bursitis 48.43 15.35 3 41572 131651 90455221
Dizziness 48.40 15.35 126 41449 589158 89997714
Muscle relaxant therapy 48.31 15.35 12 41563 161 90586711
Renal impairment 47.99 15.35 131 41444 105290 90481582
Neuromuscular block prolonged 47.98 15.35 16 41559 636 90586236
Blood bicarbonate decreased 47.95 15.35 25 41550 3094 90583778
Intestinal infarction 47.38 15.35 18 41557 1049 90585823
Electrocardiogram ST segment elevation 47.34 15.35 27 41548 3989 90582883
Ventricular extrasystoles 47.22 15.35 43 41532 13207 90573665
Delirium 46.82 15.35 129 41446 104230 90482642
Reversal of sedation 46.81 15.35 7 41568 0 90586872
Acidosis 46.70 15.35 42 41533 12694 90574178
Electrocardiogram ST segment depression 46.61 15.35 25 41550 3278 90583594
Epileptic aura 46.37 15.35 10 41565 68 90586804
Osteoarthritis 46.26 15.35 16 41559 195714 90391158
Erythema 46.23 15.35 218 41357 229028 90357844
Therapeutic product effect decreased 45.96 15.35 36 41539 277535 90309337
Perforation 45.73 15.35 21 41554 1973 90584899
Coma 45.50 15.35 102 41473 72530 90514342
Asthenia 45.47 15.35 112 41463 533639 90053233
Left ventricular dysfunction 45.37 15.35 44 41531 14625 90572247
Hepatorenal syndrome 45.19 15.35 21 41554 2027 90584845
Acute respiratory failure 45.04 15.35 75 41500 42843 90544029
Schizencephaly 44.54 15.35 13 41562 330 90586542
Posterior reversible encephalopathy syndrome 44.36 15.35 53 41522 22286 90564586
Tachyphylaxis 44.18 15.35 13 41562 340 90586532
Patent ductus arteriosus 44.11 15.35 27 41548 4542 90582330
Hyperthermia malignant 43.96 15.35 18 41557 1280 90585592
Oropharyngeal oedema 43.64 15.35 13 41562 355 90586517
Systolic dysfunction 43.50 15.35 20 41555 1884 90584988
Bulimia nervosa 43.41 15.35 14 41561 500 90586372
Macroglossia 43.30 15.35 16 41559 863 90586009
Anorectal ulcer 43.29 15.35 9 41566 50 90586822
Ventricular tachycardia 43.23 15.35 55 41520 24653 90562219
Non-consummation 42.84 15.35 9 41566 53 90586819
Postictal paralysis 42.20 15.35 12 41563 277 90586595
Airway peak pressure increased 42.01 15.35 13 41562 405 90586467
Sinus bradycardia 41.79 15.35 45 41530 16907 90569965
Cholestasis 41.57 15.35 66 41509 36233 90550639
Change in seizure presentation 41.47 15.35 14 41561 578 90586294
Infection 41.19 15.35 64 41511 362030 90224842
Intensive care unit acquired weakness 41.12 15.35 16 41559 995 90585877
Diabetic macroangiopathy 41.06 15.35 10 41565 123 90586749
Migraine 40.97 15.35 18 41557 190374 90396498
Negative pressure pulmonary oedema 40.90 15.35 9 41566 68 90586804
Anaesthetic complication pulmonary 40.90 15.35 9 41566 68 90586804
Clonus 40.79 15.35 28 41547 5722 90581150
Acute hepatic failure 40.71 15.35 51 41524 22510 90564362
Cardiotoxicity 40.67 15.35 37 41538 11352 90575520
Hypertrophic cardiomyopathy 40.50 15.35 20 41555 2208 90584664
Hypoventilation 40.46 15.35 27 41548 5269 90581603
Gastrooesophageal reflux disease 40.35 15.35 13 41562 166324 90420548
Atrioventricular block 40.33 15.35 33 41542 8782 90578090
Electrocardiogram QT prolonged 40.18 15.35 97 41478 72359 90514513
Cerebral haemorrhage foetal 40.00 15.35 12 41563 336 90586536
Drug resistance 40.00 15.35 59 41516 30390 90556482
Muscle rigidity 38.87 15.35 40 41535 14269 90572603
Ultrasound ovary abnormal 38.83 15.35 9 41566 88 90586784
Product dose omission issue 38.78 15.35 46 41529 291641 90295231
Therapy cessation 38.77 15.35 64 41511 36297 90550575
Somnolence 38.68 15.35 194 41381 208890 90377982
Hypernatraemia 38.52 15.35 33 41542 9354 90577518
Toxic epidermal necrolysis 38.44 15.35 60 41515 32468 90554404
Pseudopolyp 38.23 15.35 12 41563 392 90586480
Sinus arrest 38.23 15.35 19 41556 2127 90584745
Hepatocellular injury 37.88 15.35 56 41519 28902 90557970
Wound infection 37.47 15.35 3 41572 106399 90480473
Carcinoid crisis 37.40 15.35 11 41564 287 90586585
Therapeutic product effect incomplete 37.36 15.35 182 41393 193714 90393158
Anaemia 37.17 15.35 283 41292 352519 90234353
Intensive care unit delirium 36.89 15.35 8 41567 56 90586816
Postoperative delirium 36.24 15.35 10 41565 206 90586666
Encephalitis autoimmune 36.01 15.35 18 41557 2040 90584832
Constipation 35.39 15.35 235 41340 280160 90306712
Road traffic accident 35.35 15.35 4 41571 107622 90479250
Maternal exposure during delivery 35.28 15.35 22 41553 3824 90583048
Dystonia 35.21 15.35 41 41534 16778 90570094
Night sweats 35.11 15.35 8 41567 128758 90458114
Hypercholesterolaemia 35.10 15.35 3 41572 100889 90485983
Sedation complication 34.97 15.35 41 41534 16903 90569969
Paraesthesia 34.88 15.35 38 41537 250288 90336584
Seizure cluster 34.52 15.35 11 41564 378 90586494
Myoglobin blood increased 34.51 15.35 16 41559 1536 90585336
Pyrexia 34.51 15.35 458 41117 660027 89926845
Obesity 34.45 15.35 4 41571 105503 90481369
Brain death 34.38 15.35 22 41553 3999 90582873
Muscle spasms 34.26 15.35 39 41536 251844 90335028
Drug reaction with eosinophilia and systemic symptoms 33.72 15.35 66 41509 42692 90544180
Tracheal injury 33.66 15.35 9 41566 164 90586708
Drug level below therapeutic 33.62 15.35 25 41550 5789 90581083
Psoriasis 33.35 15.35 13 41562 147741 90439131
Osteoporosis 33.23 15.35 3 41572 96528 90490344
Device related sepsis 33.20 15.35 23 41552 4770 90582102
Oedema 33.11 15.35 26 41549 200269 90386603
Oliguria 33.10 15.35 32 41543 10592 90576280
Gait inability 32.87 15.35 13 41562 146443 90440429
Rebound effect 32.56 15.35 30 41545 9354 90577518
Back pain 32.44 15.35 60 41515 317115 90269757
Loss of personal independence in daily activities 32.37 15.35 11 41564 136094 90450778
Epilepsy with myoclonic-atonic seizures 32.37 15.35 8 41567 105 90586767
Chest pain 32.22 15.35 61 41514 319584 90267288
Unmasking of previously unidentified disease 32.15 15.35 15 41560 1461 90585411
C-reactive protein increased 31.99 15.35 22 41553 181367 90405505
Tachypnoea 31.98 15.35 44 41531 21265 90565607
Oedema peripheral 31.86 15.35 43 41532 257872 90329000
Foetal death 31.42 15.35 43 41532 20680 90566192
Injection site reaction 31.33 15.35 3 41572 92077 90494795
Acid base balance abnormal 31.20 15.35 10 41565 350 90586522
Alanine aminotransferase increased 31.13 15.35 122 41453 118216 90468656
Acute coronary syndrome 30.78 15.35 31 41544 10782 90576090
Endotracheal intubation 30.25 15.35 19 41556 3345 90583527
Mixed liver injury 29.66 15.35 26 41549 7597 90579275
Lactic acidosis 29.53 15.35 69 41506 50394 90536478
Haemoperitoneum 29.42 15.35 19 41556 3509 90583363
Hypotonia 29.35 15.35 31 41544 11395 90575477
Product administered to patient of inappropriate age 29.15 15.35 21 41554 4632 90582240
Bronchitis 29.09 15.35 17 41558 152910 90433962
Gastrointestinal scarring 29.03 15.35 10 41565 439 90586433
Product use issue 29.03 15.35 68 41507 329851 90257021
Rhabdomyolysis 28.82 15.35 69 41506 51187 90535685
Adverse event 28.79 15.35 9 41566 117409 90469463
Torsade de pointes 28.48 15.35 35 41540 15147 90571725
Pulmonary hypertensive crisis 28.44 15.35 10 41565 467 90586405
Lower limb fracture 28.32 15.35 3 41572 85010 90501862
Left ventricular hypertrophy 28.11 15.35 23 41552 6121 90580751
Myocardial ischaemia 27.80 15.35 33 41542 13781 90573091
Epilepsy 27.80 15.35 92 41483 82114 90504758
Vulvovaginal candidiasis 27.69 15.35 19 41556 3881 90582991
Nail dystrophy 27.49 15.35 13 41562 1305 90585567
Neurotoxicity 27.34 15.35 41 41534 21426 90565446
Laryngeal stenosis 27.30 15.35 13 41562 1326 90585546
Gastrointestinal mucosa hyperaemia 27.27 15.35 8 41567 207 90586665
Hepatic cytolysis 27.20 15.35 50 41525 30866 90556006
Tonic clonic movements 27.04 15.35 14 41561 1708 90585164
Death 26.96 15.35 324 41251 456227 90130645
Pulmonary fibrosis 26.79 15.35 8 41567 107495 90479377
Lung disorder 26.67 15.35 18 41557 149865 90437007
Stevens-Johnson syndrome 26.46 15.35 48 41527 29328 90557544
Myocardial calcification 26.40 15.35 8 41567 232 90586640
Hyperammonaemic encephalopathy 26.18 15.35 16 41559 2683 90584189
Clonic convulsion 26.00 15.35 11 41564 849 90586023
Gait disturbance 25.99 15.35 50 41525 260446 90326426
Neurodevelopmental disorder 25.98 15.35 8 41567 245 90586627
Pituitary apoplexy 25.33 15.35 7 41568 145 90586727
Dyschezia 25.31 15.35 16 41559 2849 90584023
Pulmonary oedema 25.17 15.35 74 41501 62006 90524866
Gaze palsy 24.79 15.35 13 41562 1628 90585244
Restlessness 24.45 15.35 52 41523 35668 90551204
Pseudomonas infection 24.30 15.35 32 41543 14833 90572039
Injury 24.27 15.35 33 41542 197316 90389556
Paralysis 24.06 15.35 28 41547 11450 90575422
Euthyroid sick syndrome 24.05 15.35 6 41569 82 90586790
Nausea 23.99 15.35 362 41213 1109954 89476918
Electrocardiogram repolarisation abnormality 23.97 15.35 12 41563 1364 90585508
Hyperaesthesia 23.94 15.35 27 41548 10675 90576197
Hypovolaemia 23.87 15.35 29 41546 12402 90574470
Pulmonary sepsis 23.65 15.35 14 41561 2217 90584655
Palpitations 23.55 15.35 17 41558 136711 90450161
Congenital clavicular agenesis 23.53 15.35 6 41569 90 90586782
Procedural vomiting 23.53 15.35 10 41565 781 90586091
Apallic syndrome 23.47 15.35 10 41565 786 90586086
Axillary pain 23.14 15.35 14 41561 2307 90584565
Encephalitis 23.07 15.35 27 41548 11107 90575765
Hyperthermia 22.99 15.35 26 41549 10309 90576563
Subdural haemorrhage 22.71 15.35 16 41559 3407 90583465
Ventricular fibrillation 22.60 15.35 30 41545 14014 90572858
Liver injury 22.55 15.35 27 41548 170540 90416332
Injection site pain 22.43 15.35 28 41547 173671 90413201
Atrioventricular dissociation 22.32 15.35 7 41568 228 90586644
Bronchopulmonary dysplasia 22.32 15.35 9 41566 615 90586257
Acidosis hyperchloraemic 22.22 15.35 10 41565 896 90585976
Coagulopathy 22.19 15.35 39 41536 23250 90563622
Stridor 22.05 15.35 18 41557 4775 90582097
Haematemesis 21.83 15.35 48 41527 33678 90553194
Catheter site haemorrhage 21.72 15.35 16 41559 3652 90583220
Airway complication of anaesthesia 21.71 15.35 8 41567 428 90586444
Suicide attempt 21.69 15.35 80 41495 75319 90511553
Increased bronchial secretion 21.50 15.35 13 41562 2140 90584732
Tonic convulsion 21.34 15.35 12 41563 1726 90585146
Muscular weakness 21.20 15.35 39 41536 206627 90380245
Hyperammonaemia 21.12 15.35 20 41555 6455 90580417
Carbohydrate antigen 125 increased 21.06 15.35 15 41560 3251 90583621
Infusion related reaction 21.02 15.35 109 41466 416671 90170201
Acute kidney injury 20.97 15.35 232 41343 320155 90266717
Post procedural stroke 20.80 15.35 5 41570 58 90586814
Laryngospasm 20.78 15.35 15 41560 3318 90583554
Delayed graft function 20.71 15.35 11 41564 1414 90585458
Coronary artery bypass 20.45 15.35 13 41562 2336 90584536
Respiratory distress 20.37 15.35 51 41524 38895 90547977
Myocardial stunning 20.35 15.35 7 41568 306 90586566
Hip arthroplasty 20.25 15.35 5 41570 76203 90510669
Premature baby 20.13 15.35 39 41536 25038 90561834
Therapeutic response decreased 20.07 15.35 8 41567 89721 90497151
Psychomotor hyperactivity 20.05 15.35 27 41548 12786 90574086
Infection parasitic 19.96 15.35 8 41567 538 90586334
Retrograde amnesia 19.85 15.35 8 41567 546 90586326
Defaecation urgency 19.82 15.35 19 41556 6223 90580649
Apnoeic attack 19.72 15.35 7 41568 336 90586536
Respiratory rate increased 19.58 15.35 30 41545 15971 90570901
Inappropriate schedule of product administration 19.54 15.35 24 41551 149909 90436963
Renal infarct 19.42 15.35 11 41564 1604 90585268
Headache 19.39 15.35 279 41296 862467 89724405
Sepsis 19.33 15.35 145 41430 179669 90407203
Knee arthroplasty 19.30 15.35 7 41568 83175 90503697
Nephrocalcinosis 19.30 15.35 10 41565 1222 90585650
Neuromuscular blockade 19.28 15.35 7 41568 359 90586513
Drug dependence 19.28 15.35 42 41533 29285 90557587
Ventricular dysfunction 19.27 15.35 15 41560 3716 90583156
Bronchoalveolar lavage abnormal 19.06 15.35 6 41569 198 90586674
Coronary artery embolism 19 15.35 6 41569 200 90586672
Procedural complication 18.87 15.35 18 41557 5860 90581012
Epileptic encephalopathy 18.86 15.35 7 41568 382 90586490
Resuscitation 18.82 15.35 10 41565 1286 90585586
Granulomatous liver disease 18.70 15.35 9 41566 940 90585932
Hepatitis acute 18.67 15.35 24 41551 10863 90576009
Injection site erythema 18.66 15.35 11 41564 98491 90488381
Blood magnesium decreased 18.61 15.35 29 41546 15664 90571208
Transcranial electrical motor evoked potential monitoring abnormal 18.57 15.35 4 41571 27 90586845
Neck pain 18.57 15.35 15 41560 113948 90472924
White blood cell count decreased 18.54 15.35 30 41545 167079 90419793
Necrotising colitis 18.52 15.35 10 41565 1328 90585544
Therapeutic product effect prolonged 18.44 15.35 7 41568 407 90586465
Pulse absent 18.42 15.35 18 41557 6037 90580835
Bradypnoea 18.35 15.35 16 41559 4642 90582230
Adverse drug reaction 18.23 15.35 16 41559 116685 90470187
Intermittent claudication 18.18 15.35 11 41564 1812 90585060
Foetal exposure during pregnancy 18.16 15.35 52 41523 42923 90543949
Decreased appetite 18.14 15.35 100 41475 376440 90210432
Symptom masked 18.07 15.35 9 41566 1012 90585860
Burkholderia test positive 18.00 15.35 6 41569 238 90586634
Pneumonia fungal 17.92 15.35 19 41556 7012 90579860
General physical health deterioration 17.83 15.35 93 41482 355022 90231850
Foot deformity 17.74 15.35 3 41572 59648 90527224
Post procedural haemorrhage 17.67 15.35 21 41554 8777 90578095
Fanconi syndrome 17.54 15.35 11 41564 1932 90584940
Influenza 17.41 15.35 23 41552 139241 90447631
Dyspnoea 17.39 15.35 292 41283 880663 89706209
C-reactive protein decreased 17.38 15.35 9 41566 1098 90585774
Loss of consciousness 17.34 15.35 117 41458 140121 90446751
Urinary retention 17.26 15.35 47 41528 37697 90549175
White matter lesion 17.23 15.35 12 41563 2509 90584363
Gastrointestinal vascular malformation 17.09 15.35 4 41571 41 90586831
Focal dyscognitive seizures 17.03 15.35 13 41562 3131 90583741
Selective eating disorder 16.98 15.35 11 41564 2042 90584830
Hyperdynamic left ventricle 16.91 15.35 6 41569 288 90586584
Tonsillar hypertrophy 16.90 15.35 9 41566 1163 90585709
Antinuclear antibody positive 16.85 15.35 21 41554 9220 90577652
Renal injury 16.66 15.35 22 41553 10221 90576651
Renal failure 16.62 15.35 110 41465 130897 90455975
Acute postoperative sialadenitis 16.59 15.35 4 41571 47 90586825
Hypokalaemia 16.58 15.35 110 41465 131006 90455866
Large intestinal ulcer 16.54 15.35 14 41561 3903 90582969
Extrapyramidal disorder 16.45 15.35 28 41547 16275 90570597
Intentional product misuse to child 16.44 15.35 4 41571 49 90586823
Confusional state 16.27 15.35 107 41468 386098 90200774
Methaemoglobinaemia 16.24 15.35 14 41561 4001 90582871
Acetonaemia 16.20 15.35 6 41569 326 90586546
Depression 16.07 15.35 77 41498 300524 90286348
Procedural intestinal perforation 16.03 15.35 5 41570 160 90586712
Blepharospasm 16.03 15.35 3 41572 55442 90531430
Enzyme induction 15.81 15.35 4 41571 58 90586814
Manipulation 15.81 15.35 4 41571 58 90586814
Post procedural complication 15.76 15.35 30 41545 19012 90567860
Neonatal seizure 15.74 15.35 7 41568 610 90586262
Pancreatic enzymes abnormal 15.67 15.35 3 41572 10 90586862
Cough 15.66 15.35 102 41473 368860 90218012
Blood pressure decreased 15.64 15.35 72 41503 74823 90512049
Leukocytosis 15.60 15.35 40 41535 30950 90555922
Treatment failure 15.59 15.35 79 41496 303849 90283023
Malaise 15.53 15.35 183 41392 585803 90001069
Septic shock 15.48 15.35 78 41497 84082 90502790
Abdominal pain 15.37 15.35 261 41314 395460 90191412

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 ineffective 389.27 13.88 1306 35512 628891 41955626
Status epilepticus 356.40 13.88 201 36617 15377 42569140
Drug ineffective for unapproved indication 264.25 13.88 258 36560 45905 42538612
Multiple-drug resistance 245.57 13.88 122 36696 7200 42577317
Hypotension 218.57 13.88 599 36219 257032 42327485
Rhabdomyolysis 207.16 13.88 294 36524 77725 42506792
Hyperthermia malignant 202.90 13.88 79 36739 2579 42581938
Cardiac arrest 189.52 13.88 339 36479 108981 42475536
Propofol infusion syndrome 188.21 13.88 61 36757 1148 42583369
Hypoxia 173.56 13.88 255 36563 69531 42514986
Anaphylactic reaction 165.11 13.88 194 36624 42549 42541968
Drug reaction with eosinophilia and systemic symptoms 159.26 13.88 189 36629 41886 42542631
Myoclonus 148.62 13.88 121 36697 16944 42567573
Respiratory failure 145.14 13.88 333 36485 127799 42456718
Bradycardia 141.58 13.88 260 36558 85224 42499293
Diabetes insipidus 136.86 13.88 66 36752 3647 42580870
Serotonin syndrome 135.88 13.88 138 36680 25707 42558810
Anaphylactic shock 133.65 13.88 131 36687 23386 42561131
Fatigue 132.00 13.88 110 36708 435531 42148986
Off label use 128.26 13.88 964 35854 637371 41947146
Respiratory depression 116.45 13.88 110 36708 18758 42565759
Diarrhoea 115.89 13.88 137 36681 460712 42123805
Intensive care unit acquired weakness 111.95 13.88 42 36776 1236 42583281
Anaesthetic complication neurological 109.96 13.88 36 36782 700 42583817
Agitation 101.91 13.88 192 36626 64122 42520395
Generalised tonic-clonic seizure 98.96 13.88 118 36700 26261 42558256
Delirium 92.31 13.88 164 36654 52355 42532162
Seizure 91.73 13.88 270 36548 120291 42464226
Oxygen saturation decreased 91.38 13.88 184 36634 64503 42520014
Multiple organ dysfunction syndrome 90.36 13.88 234 36584 96801 42487716
Tachycardia 90.29 13.88 240 36578 100847 42483670
Metabolic acidosis 89.94 13.88 161 36657 51697 42532820
Sedation complication 87.23 13.88 45 36773 2874 42581643
Coma 86.22 13.88 161 36657 53393 42531124
Nausea 83.51 13.88 134 36684 396665 42187852
Toxicity to various agents 83.48 13.88 405 36413 228731 42355786
Haemodynamic instability 82.86 13.88 76 36742 12481 42572036
Arthralgia 82.59 13.88 37 36781 205201 42379316
Electroencephalogram abnormal 80.51 13.88 43 36775 2949 42581568
Delayed recovery from anaesthesia 79.61 13.88 32 36786 1137 42583380
Dizziness 78.98 13.88 60 36758 249194 42335323
Autonomic nervous system imbalance 78.87 13.88 43 36775 3073 42581444
Hyperthermia 76.99 13.88 73 36745 12501 42572016
Depressed level of consciousness 76.95 13.88 144 36674 47826 42536691
Respiratory acidosis 75.16 13.88 54 36764 6277 42578240
Brain oedema 73.01 13.88 80 36738 16247 42568270
Product dose omission issue 71.87 13.88 22 36796 154343 42430174
Drug interaction 70.94 13.88 433 36385 266566 42317951
Shock 70.27 13.88 105 36713 29016 42555501
Headache 69.18 13.88 63 36755 239306 42345211
Unresponsive to stimuli 68.43 13.88 108 36710 31295 42553222
Partial seizures 65.07 13.88 48 36770 5811 42578706
Acute respiratory distress syndrome 64.85 13.88 103 36715 30005 42554512
Hypercapnia 64.26 13.88 46 36772 5315 42579202
Dyspnoea 63.58 13.88 185 36633 442436 42142081
Trigemino-cardiac reflex 63.00 13.88 20 36798 351 42584166
Kounis syndrome 62.57 13.88 38 36780 3330 42581187
Apnoea 61.01 13.88 52 36766 7751 42576766
Overdose 60.29 13.88 214 36604 105050 42479467
Drug withdrawal syndrome 58.26 13.88 82 36736 21467 42563050
Necrosis ischaemic 57.91 13.88 19 36799 372 42584145
Pruritus 57.78 13.88 47 36771 188724 42395793
Neuroleptic malignant syndrome 54.07 13.88 79 36739 21393 42563124
Electrocardiogram ST segment elevation 53.57 13.88 43 36775 5896 42578621
Pain in extremity 53.35 13.88 32 36786 150572 42433945
Myalgia 51.91 13.88 10 36808 96070 42488447
Peripheral swelling 51.83 13.88 8 36810 90262 42494255
Pulseless electrical activity 51.68 13.88 49 36769 8388 42576129
No adverse event 51.54 13.88 108 36710 38913 42545604
Asthenia 50.75 13.88 104 36714 280689 42303828
Respiratory arrest 50.22 13.88 89 36729 28335 42556182
Catatonia 49.64 13.88 42 36776 6197 42578320
Dyskinesia 49.44 13.88 83 36735 25307 42559210
Epilepsy 48.91 13.88 84 36734 26087 42558430
Hypoventilation 48.76 13.88 34 36784 3768 42580749
Stress cardiomyopathy 48.12 13.88 30 36788 2755 42581762
Back pain 47.64 13.88 32 36786 141744 42442773
Hyperammonaemia 46.89 13.88 45 36773 7821 42576696
Product administered to patient of inappropriate age 46.23 13.88 36 36782 4725 42579792
Brain death 45.76 13.88 30 36788 3004 42581513
Septic shock 45.49 13.88 178 36640 91494 42493023
Seizure like phenomena 45.02 13.88 21 36797 1076 42583441
Nasopharyngitis 44.83 13.88 9 36809 83987 42500530
Acidosis hyperchloraemic 44.20 13.88 18 36800 662 42583855
Toxic epidermal necrolysis 43.75 13.88 81 36737 26669 42557848
Behaviour disorder 43.27 13.88 41 36777 7013 42577504
Reversal of sedation 42.82 13.88 9 36809 24 42584493
Abdominal discomfort 42.45 13.88 7 36811 75248 42509269
Acidosis 41.30 13.88 52 36766 12227 42572290
Coagulopathy 41.24 13.88 71 36747 22091 42562426
Pain 40.66 13.88 95 36723 244753 42339764
Cyanosis 40.33 13.88 57 36761 14974 42569543
Weight decreased 40.16 13.88 74 36744 207874 42376643
Nervous system disorder 40.05 13.88 61 36757 17134 42567383
White blood cell count decreased 39.73 13.88 23 36795 110373 42474144
Laryngospasm 38.40 13.88 23 36795 1965 42582552
Mucosal ulceration 37.96 13.88 20 36798 1334 42583183
Oxygen therapy 37.90 13.88 20 36798 1338 42583179
Dehydration 37.80 13.88 40 36778 141727 42442790
Anticonvulsant drug level below therapeutic 36.65 13.88 16 36802 701 42583816
COVID-19 pneumonia 36.04 13.88 66 36752 21547 42562970
Endotracheal intubation 35.41 13.88 28 36790 3757 42580760
Intestinal ischaemia 35.20 13.88 42 36776 9346 42575171
Post procedural hypotension 35.01 13.88 9 36809 70 42584447
Rash maculo-papular 34.40 13.88 90 36728 37413 42547104
Dissociative disorder 34.36 13.88 15 36803 657 42583860
Muscle rigidity 34.25 13.88 47 36771 12012 42572505
Sedation 34.18 13.88 79 36739 30396 42554121
Anaesthetic complication 33.84 13.88 19 36799 1438 42583079
Burkholderia test positive 33.73 13.88 17 36801 1033 42583484
Blood lactic acid increased 33.54 13.88 38 36780 8001 42576516
Cholestasis 33.38 13.88 82 36736 32797 42551720
Diabetes mellitus 32.99 13.88 6 36812 60081 42524436
Local anaesthetic systemic toxicity 32.89 13.88 22 36796 2278 42582239
Encephalitis autoimmune 32.10 13.88 18 36800 1359 42583158
Circulatory collapse 31.88 13.88 66 36752 23570 42560947
Corneal reflex decreased 31.63 13.88 10 36808 173 42584344
Weight increased 30.46 13.88 29 36789 107954 42476563
Electrocardiogram QRS complex prolonged 30.41 13.88 31 36787 5792 42578725
Vomiting 30.30 13.88 138 36680 289585 42294932
Malaise 30.10 13.88 89 36729 212067 42372450
Leukocytosis 30.06 13.88 74 36744 29634 42554883
Tachypnoea 29.82 13.88 61 36757 21601 42562916
Respiratory distress 29.24 13.88 91 36727 41729 42542788
Inappropriate schedule of product administration 29.16 13.88 24 36794 95878 42488639
Neuropathy peripheral 29.14 13.88 27 36791 101826 42482691
Product use in unapproved indication 28.79 13.88 264 36554 184192 42400325
Long QT syndrome 28.71 13.88 23 36795 3144 42581373
Withdrawal syndrome 28.36 13.88 48 36770 14727 42569790
Thrombosis 28.06 13.88 12 36806 68499 42516018
Superinfection 27.97 13.88 22 36796 2929 42581588
Vasoplegia syndrome 27.80 13.88 21 36797 2634 42581883
Myocardial infarction 27.78 13.88 40 36778 123969 42460548
Administration related reaction 27.63 13.88 9 36809 172 42584345
Clonic convulsion 27.62 13.88 14 36804 861 42583656
Therapy interrupted 27.55 13.88 60 36758 22190 42562327
Misleading laboratory test result 27.32 13.88 6 36812 21 42584496
Drug resistance 27.23 13.88 78 36740 34170 42550347
Coma neonatal 26.90 13.88 6 36812 23 42584494
Cardio-respiratory arrest 26.79 13.88 111 36707 58525 42525992
Haemoglobin decreased 26.58 13.88 46 36772 132425 42452092
Cardiac failure congestive 26.55 13.88 21 36797 85581 42498936
Psoriasis 26.37 13.88 5 36813 48599 42535918
Herpes simplex viraemia 26.30 13.88 8 36810 121 42584396
Hypertransaminasaemia 26.26 13.88 36 36782 9191 42575326
Intensive care 26.19 13.88 15 36803 1179 42583338
Constipation 26.09 13.88 64 36754 162227 42422290
Malignant catatonia 25.95 13.88 11 36807 448 42584069
Neutropenia 25.94 13.88 87 36731 199344 42385173
Harlequin skin reaction 25.90 13.88 5 36813 7 42584510
Neuromuscular block prolonged 25.87 13.88 12 36806 607 42583910
Brain hypoxia 25.54 13.88 12 36806 625 42583892
Hypotonia 25.45 13.88 36 36782 9463 42575054
Asthma 25.39 13.88 11 36807 62303 42522214
Encephalopathy 25.34 13.88 86 36732 41247 42543270
Decreased appetite 25.29 13.88 84 36734 193053 42391464
Ventricular tachycardia 25.26 13.88 70 36748 30090 42554427
Hyporesponsive to stimuli 25.07 13.88 16 36802 1530 42582987
Klebsiella infection 24.71 13.88 39 36779 11293 42573224
Abdominal pain upper 24.71 13.88 21 36797 82588 42501929
Abdominal compartment syndrome 24.56 13.88 14 36804 1091 42583426
Dry mouth 24.14 13.88 3 36815 39876 42544641
Ileus 24.14 13.88 52 36766 19087 42565430
Oedema peripheral 24.02 13.88 51 36767 136025 42448492
Respiratory rate decreased 23.79 13.88 20 36798 2925 42581592
Aggression 23.74 13.88 88 36730 44075 42540442
Fall 23.73 13.88 113 36705 234407 42350110
Bronchospasm 23.60 13.88 41 36777 12844 42571673
Urinary bladder rupture 23.58 13.88 7 36811 97 42584420
Brain injury 23.52 13.88 31 36787 7624 42576893
Artery dissection 23.37 13.88 9 36809 285 42584232
Blood pressure decreased 23.26 13.88 106 36712 58226 42526291
Ventricular asystole 23.19 13.88 9 36809 291 42584226
Procedural complication 23.02 13.88 23 36795 4196 42580321
Intracranial pressure increased 22.82 13.88 24 36794 4650 42579867
Neonatal respiratory depression 22.53 13.88 10 36808 456 42584061
Kidney congestion 22.39 13.88 10 36808 463 42584054
Cough 22.27 13.88 79 36739 178024 42406493
Dry skin 22.27 13.88 7 36811 48331 42536186
Bradypnoea 22.24 13.88 23 36795 4370 42580147
Defect conduction intraventricular 22.23 13.88 10 36808 471 42584046
Large intestine anastomosis 22.18 13.88 6 36812 58 42584459
Laryngomalacia 22.15 13.88 9 36809 329 42584188
Therapy non-responder 22.05 13.88 98 36720 53261 42531256
Cellulitis 21.90 13.88 13 36805 61572 42522945
Ventricular arrhythmia 21.77 13.88 27 36791 6252 42578265
Altered state of consciousness 21.69 13.88 65 36753 29194 42555323
Hepatitis fulminant 21.65 13.88 24 36794 4935 42579582
Lung hyperinflation 21.63 13.88 13 36805 1118 42583399
Sinusitis 21.52 13.88 7 36811 47285 42537232
Abdominal pain 20.92 13.88 89 36729 190382 42394135
Sinus bradycardia 20.65 13.88 42 36776 14811 42569706
Endotracheal intubation complication 20.41 13.88 9 36809 404 42584113
Mixed dementia 20.40 13.88 8 36810 266 42584251
Reduced facial expression 20.34 13.88 14 36804 1519 42582998
Upper airway obstruction 20.21 13.88 11 36807 783 42583734
Haemophagocytic lymphohistiocytosis 20.17 13.88 47 36771 18175 42566342
Liver function test 20.09 13.88 6 36812 85 42584432
Neurotoxicity 19.91 13.88 55 36763 23596 42560921
Systemic inflammatory response syndrome 19.79 13.88 28 36790 7362 42577155
Negative pressure pulmonary oedema 19.73 13.88 10 36808 615 42583902
Therapy cessation 19.70 13.88 50 36768 20400 42564117
Dyspnoea paroxysmal nocturnal 19.64 13.88 14 36804 1606 42582911
Thrombotic microangiopathy 19.61 13.88 41 36777 14741 42569776
Medical device site fistula 19.44 13.88 5 36813 39 42584478
Hyperbilirubinaemia 19.41 13.88 50 36768 20585 42563932
Transient ischaemic attack 19.33 13.88 3 36815 33736 42550781
Anti factor V antibody 19.32 13.88 8 36810 307 42584210
Mumps 19.30 13.88 6 36812 98 42584419
Paraesthesia 19.26 13.88 21 36797 73438 42511079
Hypoaesthesia 19.22 13.88 20 36798 71443 42513074
Airway complication of anaesthesia 19.19 13.88 7 36811 190 42584327
Dyspepsia 19.03 13.88 6 36812 41346 42543171
Fear 18.93 13.88 34 36784 10931 42573586
Clonus 18.86 13.88 19 36799 3501 42581016
Hyperammonaemic encephalopathy 18.79 13.88 17 36801 2741 42581776
Haematuria traumatic 18.62 13.88 8 36810 337 42584180
Anaemia 18.54 13.88 154 36664 280124 42304393
Neuromuscular blockade 18.49 13.88 8 36810 343 42584174
Hypernatraemia 18.48 13.88 32 36786 10000 42574517
Loss of personal independence in daily activities 18.45 13.88 10 36808 49806 42534711
Plasma cell myeloma 18.45 13.88 9 36809 47569 42536948
Disease progression 18.44 13.88 63 36755 143593 42440924
Respiratory disorder 18.24 13.88 51 36767 22034 42562483
Heart alternation 18.17 13.88 3 36815 0 42584517
Blood pressure increased 18.15 13.88 38 36780 101890 42482627
Condition aggravated 18.08 13.88 321 36497 260433 42324084
Neutrophil count decreased 17.91 13.88 17 36801 63398 42521119
Areflexia 17.88 13.88 19 36799 3724 42580793
Illusion 17.56 13.88 11 36807 1018 42583499
Electrocardiogram QT prolonged 17.56 13.88 85 36733 47860 42536657
Skin exfoliation 17.46 13.88 7 36811 41546 42542971
Paradoxical drug reaction 17.44 13.88 21 36797 4717 42579800
Arteriospasm coronary 17.44 13.88 21 36797 4717 42579800
Arthrofibrosis 17.43 13.88 5 36813 61 42584456
Buttock injury 17.35 13.88 5 36813 62 42584455
Encephalomalacia 17.25 13.88 11 36807 1050 42583467
Somnolence 17.20 13.88 192 36626 140913 42443604
Odynophagia 17.17 13.88 25 36793 6745 42577772
Hypocapnia 17.13 13.88 8 36810 411 42584106
Myoclonic epilepsy 17.00 13.88 13 36805 1661 42582856
Hypertriglyceridaemia 16.98 13.88 31 36787 10095 42574422
Visual impairment 16.95 13.88 8 36810 43105 42541412
Cataract 16.92 13.88 3 36815 30601 42553916
Chest discomfort 16.88 13.88 18 36800 63598 42520919
Nystagmus 16.80 13.88 22 36796 5374 42579143
Bronchitis 16.73 13.88 10 36808 47191 42537326
Hepatic cytolysis 16.58 13.88 56 36762 26788 42557729
Prostate cancer 16.48 13.88 9 36809 44634 42539883
Periventricular haemorrhage neonatal 16.46 13.88 4 36814 24 42584493
Airway peak pressure increased 16.34 13.88 6 36812 166 42584351
Gait disturbance 16.25 13.88 38 36780 97962 42486555
Arthritis 16.24 13.88 8 36810 42057 42542460
Rash 16.20 13.88 157 36661 276797 42307720
Postresuscitation encephalopathy 16.05 13.88 4 36814 27 42584490
Intra-abdominal haemorrhage 16.05 13.88 16 36802 2912 42581605
Chills 15.98 13.88 36 36782 94030 42490487
Therapeutic product effect prolonged 15.94 13.88 7 36811 311 42584206
Myotonic dystrophy 15.82 13.88 6 36812 182 42584335
Atonic urinary bladder 15.80 13.88 4 36814 29 42584488
Periorbital swelling 15.64 13.88 12 36806 1541 42582976
Brain herniation 15.54 13.88 20 36798 4803 42579714
Chronic obstructive pulmonary disease 15.51 13.88 19 36799 63095 42521422
Nephrogenic diabetes insipidus 15.49 13.88 12 36806 1562 42582955
Pupil fixed 15.45 13.88 13 36805 1904 42582613
Subdural effusion 15.43 13.88 5 36813 94 42584423
Neurological examination abnormal 15.41 13.88 7 36811 337 42584180
Psychomotor hyperactivity 15.25 13.88 31 36787 10927 42573590
Hyperexplexia 15.24 13.88 4 36814 34 42584483
Myoglobinaemia 15.23 13.88 6 36812 202 42584315
Febrile neutropenia 15.19 13.88 96 36722 185607 42398910
Swelling 15.16 13.88 15 36803 54870 42529647
Victim of homicide 15.12 13.88 6 36812 206 42584311
Stupor 15.06 13.88 16 36802 3137 42581380
Phaeochromocytoma crisis 14.96 13.88 5 36813 104 42584413
Blood bromide increased 14.94 13.88 4 36814 37 42584480
Leukopenia 14.94 13.88 26 36792 74720 42509797
Shock haemorrhagic 14.91 13.88 39 36779 16203 42568314
Polyuria 14.74 13.88 29 36789 9982 42574535
Angina pectoris 14.74 13.88 5 36813 32891 42551626
Euthanasia 14.66 13.88 4 36814 40 42584477
Product packaging confusion 14.57 13.88 5 36813 113 42584404
Platelet count decreased 14.45 13.88 66 36752 138515 42446002
Angle closure glaucoma 14.31 13.88 10 36808 1112 42583405
Muscle contracture 14.26 13.88 11 36807 1424 42583093
Pulse absent 14.11 13.88 22 36796 6305 42578212
Vertigo 14.09 13.88 6 36812 34341 42550176
Gastrooesophageal reflux disease 14.01 13.88 11 36807 45012 42539505

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
Status epilepticus 754.79 13.49 383 72402 31188 110485326
Drug ineffective 740.82 13.49 2430 70355 1518110 108998404
Multiple-drug resistance 561.62 13.49 239 72546 12996 110503518
Hypotension 558.06 13.49 1128 71657 522721 109993793
Cardiac arrest 543.05 13.49 658 72127 196095 110320419
Drug ineffective for unapproved indication 511.55 13.49 471 72314 102367 110414147
Serotonin syndrome 471.49 13.49 356 72429 58797 110457717
Propofol infusion syndrome 426.66 13.49 128 72657 2461 110514053
Anaphylactic reaction 371.46 13.49 416 72369 113884 110402630
Drug interaction 302.81 13.49 866 71919 499317 110017197
Respiratory failure 302.61 13.49 523 72262 214809 110301705
Agitation 276.24 13.49 356 72429 112695 110403819
Diabetes insipidus 269.98 13.49 116 72669 6454 110510060
Fatigue 266.23 13.49 246 72539 1215712 109300802
Hypoxia 263.40 13.49 373 72412 129142 110387372
Myoclonus 259.33 13.49 197 72588 32801 110483713
Hyperthermia malignant 257.94 13.49 97 72688 3803 110512711
Anaphylactic shock 255.97 13.49 236 72549 51310 110465204
Rhabdomyolysis 255.62 13.49 354 72431 120047 110396467
Bradycardia 255.04 13.49 405 72380 155112 110361402
Seizure 254.78 13.49 493 72292 220692 110295822
Off label use 243.02 13.49 1750 71035 1498435 109018079
Joint swelling 238.57 13.49 13 72772 442832 110073682
Metabolic acidosis 237.27 13.49 310 72475 99434 110417080
Arthralgia 230.24 13.49 113 72672 779519 109736995
Tachycardia 229.73 13.49 479 72306 226166 110290348
Multiple organ dysfunction syndrome 228.27 13.49 380 72405 151330 110365184
Respiratory depression 218.88 13.49 176 72609 31825 110484689
Generalised tonic-clonic seizure 207.30 13.49 216 72569 54464 110462050
Respiratory acidosis 203.87 13.49 122 72663 13704 110502810
Abdominal discomfort 199.07 13.49 16 72769 393842 110122672
Unresponsive to stimuli 193.27 13.49 224 72561 63566 110452948
Drug reaction with eosinophilia and systemic symptoms 191.89 13.49 253 72532 81842 110434672
Oxygen saturation decreased 183.23 13.49 352 72433 156630 110359884
Peripheral swelling 182.21 13.49 25 72760 404009 110112505
Alopecia 175.77 13.49 18 72767 364735 110151779
Arthropathy 174.04 13.49 3 72782 287519 110228995
Diarrhoea 172.84 13.49 304 72481 1139201 109377313
Female genital tract fistula 171.94 13.49 117 72668 16402 110500112
Myoglobin urine present 171.31 13.49 50 72735 870 110515644
Shock 170.48 13.49 193 72592 53395 110463119
Partial seizures 169.56 13.49 101 72684 11248 110505266
Toxicity to various agents 167.85 13.49 693 72092 479862 110036652
Swelling 167.41 13.49 18 72767 351023 110165491
Rheumatoid arthritis 167.07 13.49 7 72778 299606 110216908
Vaginal flatulence 165.79 13.49 102 72683 12042 110504472
Proctitis 160.01 13.49 113 72672 16814 110499700
Intensive care unit acquired weakness 157.19 13.49 59 72726 2300 110514214
Delayed recovery from anaesthesia 157.12 13.49 58 72727 2157 110514357
Apnoea 154.93 13.49 102 72683 13537 110502977
Pain in extremity 152.32 13.49 65 72720 487053 110029461
Depressed level of consciousness 151.43 13.49 268 72517 112010 110404504
Nasopharyngitis 150.82 13.49 37 72748 394324 110122190
No adverse event 147.59 13.49 211 72574 73628 110442886
Radiculopathy 142.21 13.49 111 72674 19225 110497289
Systemic lupus erythematosus 141.60 13.49 6 72779 254332 110262182
Haemodynamic instability 140.03 13.49 118 72667 22770 110493744
Circulatory collapse 138.72 13.49 156 72629 42837 110473677
Chronic sinusitis 132.63 13.49 119 72666 24965 110491549
Drug intolerance 132.34 13.49 51 72734 406461 110110053
Necrosis ischaemic 132.23 13.49 45 72740 1314 110515200
Acute respiratory distress syndrome 132.17 13.49 169 72616 53029 110463485
Electroencephalogram abnormal 130.52 13.49 69 72716 6104 110510410
Vaginal discharge 129.96 13.49 102 72683 17806 110498708
Weight increased 128.00 13.49 58 72727 419586 110096928
Toxic encephalopathy 126.57 13.49 94 72691 15120 110501394
Dizziness 124.08 13.49 167 72618 698026 109818488
Macular degeneration 123.00 13.49 107 72678 21552 110494962
Pulseless electrical activity 120.65 13.49 95 72690 16662 110499852
Brain oedema 119.92 13.49 124 72661 30974 110485540
Wound 119.87 13.49 9 72776 234428 110282086
Coma 116.83 13.49 247 72538 117622 110398892
Pruritus 115.00 13.49 128 72657 581432 109935082
Delirium 113.62 13.49 265 72520 134760 110381754
Overdose 113.26 13.49 375 72410 233419 110283095
Therapy interrupted 112.48 13.49 151 72634 49671 110466843
Mitochondrial DNA mutation 107.18 13.49 30 72755 446 110516068
Asthma 107.03 13.49 18 72767 250273 110266241
Encephalopathy 106.09 13.49 191 72594 80864 110435650
Hyperthermia 104.80 13.49 97 72688 21175 110495339
Anaesthetic complication 104.78 13.49 50 72735 3556 110512958
Blood creatine phosphokinase increased 104.45 13.49 179 72606 72898 110443616
Electrocardiogram ST segment elevation 102.82 13.49 68 72717 9092 110507422
Intestinal ischaemia 102.25 13.49 85 72700 16094 110500420
Oral candidiasis 101.57 13.49 136 72649 44624 110471890
Pain 100.11 13.49 310 72475 954645 109561869
Asthenia 99.54 13.49 189 72596 688810 109827704
Abdominal pain upper 99.25 13.49 53 72732 349058 110167456
Sinusitis 98.57 13.49 36 72749 296652 110219862
Nausea 97.28 13.49 451 72334 1235239 109281275
Folliculitis 96.61 13.49 3 72782 167650 110348864
Systemic inflammatory response syndrome 96.18 13.49 75 72710 12968 110503546
Anaesthetic complication neurological 95.81 13.49 33 72752 1000 110515514
Hypoventilation 95.61 13.49 62 72723 8019 110508495
Paraesthesia oral 94.94 13.49 114 72671 33557 110482957
Intra-abdominal pressure increased 94.86 13.49 26 72759 356 110516158
Impaired healing 93.96 13.49 10 72775 196707 110319807
Stress cardiomyopathy 93.63 13.49 80 72705 15726 110500788
Unwanted awareness during anaesthesia 93.11 13.49 26 72759 383 110516131
Sedation complication 92.94 13.49 88 72697 19767 110496747
Altered state of consciousness 90.16 13.49 147 72638 57479 110459035
Labile blood pressure 89.74 13.49 40 72745 2431 110514083
Blood cholesterol increased 89.27 13.49 9 72776 184776 110331738
Dry mouth 88.60 13.49 13 72772 199935 110316579
Respiratory arrest 87.55 13.49 146 72639 58153 110458361
Fall 85.86 13.49 167 72618 603315 109913199
Blood lactic acid increased 85.51 13.49 76 72709 15745 110500769
Local anaesthetic systemic toxicity 84.60 13.49 50 72735 5487 110511027
Hypoaesthesia 84.58 13.49 51 72734 314172 110202342
Musculoskeletal pain 83.21 13.49 11 72774 183012 110333502
Contraindicated product administered 82.67 13.49 30 72755 248237 110268277
Electrocardiogram QRS complex prolonged 81.44 13.49 68 72717 12953 110503561
Stomatitis 79.81 13.49 39 72746 270203 110246311
Bronchospasm 79.77 13.49 99 72686 30140 110486374
Procedural pain 79.07 13.49 107 72678 35458 110481056
Mobility decreased 76.86 13.49 30 72755 237392 110279122
Irritable bowel syndrome 76.78 13.49 9 72776 164206 110352308
Headache 76.02 13.49 311 72474 882066 109634448
Mydriasis 75.95 13.49 83 72702 22074 110494440
Musculoskeletal stiffness 75.89 13.49 45 72740 279777 110236737
Product dose omission issue 75.01 13.49 61 72724 321721 110194793
Neuroleptic malignant syndrome 75.01 13.49 102 72683 33957 110482557
Upper airway obstruction 74.64 13.49 32 72753 1770 110514744
Lower respiratory tract infection 73.45 13.49 34 72751 243072 110273442
Hypercapnia 73.39 13.49 60 72725 11099 110505415
Toxic epidermal necrolysis 73.36 13.49 133 72652 56594 110459920
Sleep disorder 73.27 13.49 20 72765 198624 110317890
Muscle injury 73.13 13.49 5 72780 140802 110375712
Bursitis 72.50 13.49 3 72782 129915 110386599
Autonomic nervous system imbalance 72.47 13.49 46 72739 5734 110510780
Muscle rigidity 72.11 13.49 84 72701 23947 110492567
Trigemino-cardiac reflex 72.08 13.49 22 72763 449 110516065
Reversal of sedation 72.05 13.49 15 72770 54 110516460
Arthritis 71.75 13.49 12 72773 167574 110348940
Amylase increased 71.39 13.49 62 72723 12457 110504057
Colitis ulcerative 70.78 13.49 157 72628 77206 110439308
Back pain 69.65 13.49 85 72700 370911 110145603
C-reactive protein abnormal 69.16 13.49 4 72781 129691 110386823
Coagulopathy 68.99 13.49 108 72677 40803 110475711
Oxygen saturation abnormal 68.73 13.49 44 72741 5567 110510947
Hyperammonaemia 68.39 13.49 63 72722 13669 110502845
Ventricular tachycardia 68.20 13.49 120 72665 49889 110466625
Acidosis 68.01 13.49 79 72706 22452 110494062
Migraine 67.75 13.49 15 72770 171637 110344877
Paraesthesia 67.52 13.49 50 72735 276471 110240043
Paradoxical drug reaction 67.13 13.49 54 72731 9763 110506751
Therapy cessation 66.90 13.49 112 72673 44745 110471769
Dyspnoea 66.71 13.49 441 72344 1106431 109410083
Myocardial depression 66.40 13.49 23 72762 709 110515805
Cardio-respiratory arrest 66.36 13.49 197 72588 115639 110400875
Cholestasis 66.00 13.49 137 72648 64381 110452133
Blister 65.36 13.49 34 72751 227342 110289172
Discomfort 64.90 13.49 30 72755 214677 110301837
Brain death 64.73 13.49 45 72740 6528 110509986
CSF oligoclonal band present 63.61 13.49 20 72765 452 110516062
Gastrooesophageal reflux disease 62.94 13.49 20 72765 179956 110336558
Osteoarthritis 62.63 13.49 21 72764 182602 110333912
Acidosis hyperchloraemic 61.88 13.49 27 72758 1559 110514955
Behaviour disorder 61.62 13.49 51 72734 9596 110506918
Sinus bradycardia 61.48 13.49 86 72699 29397 110487117
Joint range of motion decreased 61.35 13.49 5 72780 121827 110394687
Ill-defined disorder 61.32 13.49 14 72771 156839 110359675
Neuromuscular block prolonged 61.24 13.49 25 72760 1222 110515292
Contusion 61.22 13.49 39 72746 233322 110283192
Septic shock 61.10 13.49 235 72550 157293 110359221
Laryngospasm 60.66 13.49 38 72747 4630 110511884
Hepatic enzyme increased 59.72 13.49 74 72711 320818 110195696
Clonus 59.72 13.49 48 72737 8668 110507846
Somnolence 59.61 13.49 367 72418 297082 110219432
Encephalitis autoimmune 59.58 13.49 34 72751 3494 110513020
Rash 59.58 13.49 308 72477 820656 109695858
Kounis syndrome 59.37 13.49 41 72744 5884 110510630
PCO2 increased 59.24 13.49 28 72757 1949 110514565
Disseminated intravascular coagulation 58.81 13.49 101 72684 41185 110475329
Product administered to patient of inappropriate age 58.80 13.49 46 72739 7990 110508524
Gastrointestinal disorder 58.74 13.49 44 72741 241908 110274606
Tachypnoea 58.27 13.49 98 72687 39297 110477217
Cardiogenic shock 57.77 13.49 121 72664 57217 110459297
Hepatic ischaemia 57.77 13.49 24 72761 1227 110515287
Frequent bowel movements 57.73 13.49 138 72647 71252 110445262
Aggression 57.40 13.49 123 72662 59087 110457427
Colitis 56.70 13.49 172 72613 102151 110414363
Troponin increased 56.45 13.49 83 72702 29683 110486831
Anticholinergic syndrome 56.01 13.49 35 72750 4245 110512269
Blood gases abnormal 55.87 13.49 24 72761 1334 110515180
Pneumatosis 55.85 13.49 22 72763 979 110515535
Procedural hypotension 55.81 13.49 29 72756 2476 110514038
Myalgia 54.55 13.49 40 72745 222341 110294173
Oedema 53.84 13.49 36 72749 209940 110306574
Electrocardiogram QT prolonged 53.80 13.49 176 72609 108784 110407730
Airway peak pressure increased 53.65 13.49 19 72766 626 110515888
Obesity 53.51 13.49 6 72779 113345 110403169
Respiratory distress 53.40 13.49 131 72654 68743 110447771
Catatonia 52.73 13.49 50 72735 11250 110505264
Dyskinesia 52.33 13.49 109 72676 51337 110465177
Hypotonia 52.27 13.49 58 72727 15687 110500827
Negative pressure pulmonary oedema 52.16 13.49 19 72766 680 110515834
Hypernatraemia 51.29 13.49 61 72724 17772 110498742
Ventricular hypokinesia 51.15 13.49 49 72736 11165 110505349
Acute respiratory failure 50.95 13.49 136 72649 75124 110441390
Cyanosis 50.82 13.49 79 72706 29662 110486852
Hypersensitivity 50.57 13.49 120 72665 403878 110112636
Acute hepatic failure 50.36 13.49 88 72697 36380 110480134
Drug withdrawal syndrome 50.20 13.49 90 72695 37964 110478550
Therapeutic product effect decreased 50.18 13.49 52 72733 244264 110272250
Psoriasis 49.95 13.49 15 72770 139978 110376536
Vocal cord dysfunction 49.94 13.49 20 72765 930 110515584
Neurotoxicity 49.62 13.49 95 72690 42112 110474402
Hepatic failure 49.37 13.49 127 72658 68612 110447902
Anticonvulsant drug level below therapeutic 49.33 13.49 21 72764 1141 110515373
Leukocytosis 48.97 13.49 109 72676 53719 110462795
C-reactive protein increased 48.70 13.49 43 72742 217876 110298638
Loss of personal independence in daily activities 48.47 13.49 19 72766 150001 110366513
Wheezing 48.39 13.49 58 72727 255172 110261342
Wrong product administered 48.31 13.49 47 72738 10913 110505601
Seizure like phenomena 48.00 13.49 26 72759 2415 110514099
Decreased appetite 47.94 13.49 157 72628 475689 110040825
Oxygen therapy 47.02 13.49 31 72754 4122 110512392
Bronchitis 45.84 13.49 23 72762 157009 110359505
Wound infection 45.81 13.49 5 72780 96460 110420054
White blood cell count decreased 45.79 13.49 50 72735 229340 110287174
Arrhythmia 45.36 13.49 124 72661 69451 110447063
Hypercholesterolaemia 44.99 13.49 4 72781 90833 110425681
Oedema peripheral 44.91 13.49 93 72692 328567 110187947
Muscle spasms 44.91 13.49 71 72714 278086 110238428
Carcinoid crisis 44.84 13.49 16 72769 539 110515975
Gene mutation 44.77 13.49 28 72757 3401 110513113
Muscle relaxant therapy 44.08 13.49 12 72773 160 110516354
Hyperammonaemic encephalopathy 43.91 13.49 33 72752 5401 110511113
Death 43.80 13.49 674 72111 698195 109818319
Injection site pain 43.64 13.49 32 72753 177890 110338624
Peripheral venous disease 43.64 13.49 3 72782 84114 110432400
Renal ischaemia 43.62 13.49 24 72761 2299 110514215
PO2 increased 43.42 13.49 21 72764 1538 110514976
Posterior reversible encephalopathy syndrome 43.28 13.49 79 72706 33782 110482732
Malaise 43.27 13.49 262 72523 671557 109844957
Rash maculo-papular 43.23 13.49 127 72658 74095 110442419
Nervous system disorder 43.10 13.49 76 72709 31645 110484869
Ventricular extrasystoles 42.74 13.49 63 72722 22578 110493936
Vomiting 42.51 13.49 389 72396 910286 109606228
Epileptic aura 42.27 13.49 10 72775 72 110516442
Seizure cluster 41.93 13.49 17 72768 816 110515698
Pleocytosis 41.42 13.49 21 72764 1703 110514811
Injection site reaction 41.33 13.49 5 72780 89065 110427449
Inappropriate schedule of product administration 41.07 13.49 44 72741 203593 110312921
Sciatica 40.94 13.49 6 72779 92393 110424121
Hepatic cytolysis 40.87 13.49 103 72682 54950 110461564
Tonic clonic movements 40.81 13.49 25 72760 2927 110513587
Procedural complication 40.77 13.49 38 72747 8367 110508147
Acute kidney injury 40.65 13.49 615 72170 634815 109881699
Perforation 40.45 13.49 21 72764 1789 110514725
Non-consummation 40.05 13.49 9 72776 50 110516464
Anorectal ulcer 39.90 13.49 9 72776 51 110516463
Epilepsy 39.26 13.49 150 72635 100059 110416455
Blood pH decreased 39.17 13.49 29 72756 4640 110511874
Anaesthetic complication pulmonary 39.08 13.49 11 72774 167 110516347
Premature delivery 38.56 13.49 71 72714 30561 110485953
Night sweats 38.54 13.49 20 72765 133963 110382551
Intensive care unit delirium 38.27 13.49 9 72776 63 110516451
Pulmonary oedema 38.06 13.49 149 72636 100510 110416004
Airway complication of anaesthesia 38.04 13.49 15 72770 669 110515845
Chest pain 38.01 13.49 124 72661 376251 110140263
Ventricular fibrillation 37.96 13.49 84 72701 41229 110475285
Intentional overdose 37.71 13.49 180 72605 132321 110384193
Fluid retention 37.70 13.49 8 72777 94299 110422215
Psychomotor hyperactivity 37.67 13.49 56 72729 20221 110496293
Dehydration 37.42 13.49 80 72705 279431 110237083
Red blood cell sedimentation rate increased 37.33 13.49 4 72781 78298 110438216
Blood pressure decreased 36.95 13.49 162 72623 114929 110401585
Gait disturbance 36.94 13.49 80 72705 278128 110238386
Blood potassium increased 36.85 13.49 73 72712 33176 110483338
Infusion related reaction 36.84 13.49 128 72657 381034 110135480
Neuromuscular blockade 36.82 13.49 15 72770 729 110515785
Diabetes mellitus 36.65 13.49 10 72775 99371 110417143
Unmasking of previously unidentified disease 36.40 13.49 23 72762 2845 110513669
Herpes zoster 36.22 13.49 13 72772 108366 110408148
Endotracheal intubation 36.19 13.49 31 72754 6113 110510401
Diabetic macroangiopathy 36.15 13.49 10 72775 142 110516372
Intestinal infarction 36.06 13.49 18 72767 1412 110515102
Oropharyngeal oedema 36.04 13.49 13 72772 452 110516062
Cough 35.83 13.49 169 72616 461472 110055042
Macroglossia 35.70 13.49 18 72767 1443 110515071
Ultrasound ovary abnormal 35.60 13.49 9 72776 88 110516426
Gait inability 35.47 13.49 23 72762 136353 110380161
Dystonia 35.28 13.49 62 72723 25743 110490771
Change in seizure presentation 35.17 13.49 15 72770 819 110515695
Electrocardiogram ST segment depression 35.15 13.49 29 72756 5432 110511082
Pseudopolyp 35.06 13.49 14 72771 646 110515868
Adverse event 34.79 13.49 14 72771 108795 110407719
Post procedural hypotension 34.73 13.49 9 72776 98 110516416
COVID-19 pneumonia 34.67 13.49 76 72709 37067 110479447
Clonic convulsion 34.37 13.49 18 72767 1562 110514952
Bradypnoea 34.27 13.49 35 72750 8614 110507900
Long QT syndrome 34.18 13.49 32 72753 7086 110509428
Therapeutic product effect prolonged 33.92 13.49 14 72771 704 110515810
Palpitations 33.69 13.49 33 72752 159179 110357335
Muscular weakness 33.35 13.49 71 72714 248397 110268117
Drug resistance 33.35 13.49 97 72688 56277 110460237
Lower limb fracture 33.13 13.49 5 72780 75343 110441171
Neck pain 33.08 13.49 20 72765 123110 110393404
Pneumonia aspiration 32.98 13.49 123 72662 81110 110435404
Pulmonary fibrosis 32.83 13.49 13 72772 102029 110414485
Sinus tachycardia 32.77 13.49 83 72702 44410 110472104
Hepatocellular injury 32.75 13.49 90 72695 50552 110465962
Anuria 32.66 13.49 58 72727 24283 110492231
Tonic convulsion 32.53 13.49 22 72763 3052 110513462
Withdrawal syndrome 32.52 13.49 67 72718 31313 110485201
Mucosal ulceration 32.52 13.49 20 72765 2359 110514155
Infection 32.13 13.49 126 72659 362074 110154440
Drug level below therapeutic 32.05 13.49 39 72746 11634 110504880
Brain hypoxia 31.93 13.49 16 72769 1266 110515248
Blood bicarbonate decreased 31.63 13.49 28 72757 5769 110510745
Pulse absent 31.45 13.49 38 72747 11254 110505260
Vasoplegia syndrome 31.14 13.49 27 72758 5412 110511102
Lung disorder 30.95 13.49 44 72741 180003 110336511
Postoperative delirium 30.65 13.49 14 72771 901 110515613
Feeling abnormal 30.24 13.49 45 72740 180666 110335848
General physical health deterioration 29.96 13.49 161 72624 425134 110091380
Injection site swelling 29.86 13.49 3 72782 61787 110454727
Arthrofibrosis 29.50 13.49 8 72777 105 110516409
Tachyphylaxis 29.42 13.49 11 72774 424 110516090
Renal failure 29.41 13.49 252 72533 226322 110290192
Mixed liver injury 29.40 13.49 38 72747 12041 110504473
Dissociative disorder 29.36 13.49 15 72770 1236 110515278
Epilepsy with myoclonic-atonic seizures 29.29 13.49 8 72777 108 110516406
Drug hypersensitivity 29.25 13.49 177 72608 453913 110062601
Malabsorption 29.16 13.49 28 72757 6397 110510117
Brain injury 29.13 13.49 40 72745 13436 110503078
Cardiotoxicity 29.06 13.49 45 72740 16836 110499678
Artery dissection 29.04 13.49 11 72774 440 110516074
Product use in unapproved indication 28.95 13.49 434 72351 446943 110069571
Abdominal compartment syndrome 28.40 13.49 17 72768 1910 110514604
Endotracheal intubation complication 28.33 13.49 13 72772 846 110515668
Gastrointestinal scarring 28.30 13.49 11 72774 472 110516042
Haematochezia 27.99 13.49 150 72635 115374 110401140
Cardiac failure congestive 27.88 13.49 35 72750 150965 110365549
Left ventricular dysfunction 27.76 13.49 53 72732 23440 110493074
Atrioventricular block 27.68 13.49 44 72741 16833 110499681
Tracheal injury 27.65 13.49 9 72776 228 110516286
Nystagmus 27.53 13.49 36 72749 11541 110504973
Stridor 27.49 13.49 28 72757 6867 110509647
Maternal exposure during delivery 27.37 13.49 21 72764 3544 110512970
Vagal nerve stimulator implantation 27.18 13.49 9 72776 241 110516273
Injection site erythema 27.17 13.49 14 72771 94162 110422352
Oliguria 27.04 13.49 46 72739 18611 110497903
Acute postoperative sialadenitis 27.03 13.49 7 72778 76 110516438
Inflammation 26.96 13.49 54 72731 193184 110323330
Corneal reflex decreased 26.86 13.49 11 72774 542 110515972
Road traffic accident 26.74 13.49 19 72766 107379 110409135
Brain herniation 26.62 13.49 31 72754 8832 110507682
Hypertransaminasaemia 26.57 13.49 53 72732 24202 110492312
Ventricular arrhythmia 26.56 13.49 33 72752 10054 110506460
Influenza 26.49 13.49 44 72741 169057 110347457
Rebound effect 26.24 13.49 40 72745 14766 110501748
Sinus arrest 26.21 13.49 22 72763 4220 110512294
Symptom masked 26.08 13.49 16 72769 1879 110514635
Paralysis 26.04 13.49 41 72744 15559 110500955
Rectal haemorrhage 25.98 13.49 151 72634 119682 110396832
Blood lactate dehydrogenase increased 25.95 13.49 76 72709 44258 110472256
Cataract 25.78 13.49 10 72775 79475 110437039
Ear infection 25.74 13.49 5 72780 62727 110453787
Neutropenia 25.73 13.49 143 72642 374477 110142037
Blepharospasm 25.65 13.49 3 72782 54848 110461666
Lactic acidosis 25.62 13.49 125 72660 92686 110423828
Febrile infection-related epilepsy syndrome 25.60 13.49 7 72778 95 110516419
Thrombocytopenia 25.58 13.49 346 72439 348539 110167975
Hyperbilirubinaemia 25.56 13.49 60 72725 30611 110485903
Myoclonic epilepsy 25.51 13.49 18 72767 2673 110513841
Ileus 25.48 13.49 60 72725 30669 110485845
Myoglobinaemia 25.48 13.49 8 72777 180 110516334
Intracranial pressure increased 25.42 13.49 33 72752 10502 110506012
Alanine aminotransferase increased 25.23 13.49 207 72578 183566 110332948
Foetal death 25.18 13.49 41 72744 16004 110500510
Hypertrophic cardiomyopathy 25.10 13.49 19 72766 3144 110513370
Laryngeal stenosis 25.03 13.49 14 72771 1384 110515130
Nasal congestion 24.98 13.49 17 72768 98265 110418249
Stupor 24.98 13.49 29 72756 8236 110508278
Drug dependence 24.86 13.49 81 72704 49939 110466575
Acid base balance abnormal 24.85 13.49 10 72775 471 110516043
Blood pressure increased 24.79 13.49 87 72698 258286 110258228
Loss of consciousness 24.78 13.49 217 72568 196089 110320425
Depression 24.70 13.49 116 72669 317219 110199295
Cellulitis 24.55 13.49 28 72757 125988 110390526
Anticonvulsant drug level increased 24.54 13.49 18 72767 2840 110513674
Vulvovaginal candidiasis 24.46 13.49 19 72766 3266 110513248
Dry skin 24.33 13.49 21 72764 107632 110408882
Torsade de pointes 24.30 13.49 49 72736 22551 110493963
Malignant catatonia 24.27 13.49 11 72774 695 110515819
Influenza like illness 24.26 13.49 14 72771 88398 110428116
Skin ulcer 24.24 13.49 6 72779 63639 110452875
Hepatitis fulminant 24.15 13.49 29 72756 8531 110507983
Visual impairment 23.95 13.49 32 72753 134396 110382118
Kidney congestion 23.93 13.49 10 72775 519 110515995
Nail dystrophy 23.92 13.49 13 72772 1215 110515299
Focal dyscognitive seizures 23.86 13.49 20 72765 3829 110512685
Haematuria traumatic 23.62 13.49 9 72776 366 110516148
Fear 23.42 13.49 49 72736 23144 110493370
Hypoxic-ischaemic encephalopathy 23.39 13.49 29 72756 8818 110507696
Fanconi syndrome 23.31 13.49 19 72766 3500 110513014
Procedural vomiting 23.27 13.49 12 72773 1008 110515506
Pneumomediastinum 22.96 13.49 22 72763 5014 110511500
Myocardial calcification 22.75 13.49 8 72777 258 110516256
Arteriospasm coronary 22.74 13.49 29 72756 9071 110507443
Hepatorenal syndrome 22.71 13.49 21 72764 4576 110511938
Areflexia 22.58 13.49 25 72760 6744 110509770
Ischaemic hepatitis 22.52 13.49 21 72764 4627 110511887
Ventricular asystole 22.44 13.49 9 72776 420 110516094
Neutrophil count decreased 22.36 13.49 28 72757 120913 110395601
Apallic syndrome 22.36 13.49 12 72773 1094 110515420
Hyperaesthesia 22.26 13.49 37 72748 14690 110501824
Polyuria 22.18 13.49 41 72744 17697 110498817
Manipulation 22.18 13.49 6 72779 78 110516436
Large intestinal stenosis 22.12 13.49 19 72766 3761 110512753
Post procedural complication 22.05 13.49 52 72733 26606 110489908
Mixed dementia 22.00 13.49 8 72777 285 110516229
Full blood count abnormal 21.91 13.49 5 72780 56047 110460467
Myelosuppression 21.82 13.49 18 72767 94322 110422192
Vision blurred 21.71 13.49 32 72753 128990 110387524
Chronic obstructive pulmonary disease 21.54 13.49 24 72761 109134 110407380
Bone pain 21.45 13.49 8 72777 65125 110451389
Administration related reaction 21.43 13.49 8 72777 307 110516207
Eosinophilia 21.28 13.49 85 72700 57851 110458663
Anti factor V antibody 21.26 13.49 8 72777 314 110516200
Injection site bruising 21.22 13.49 4 72781 51259 110465255
Klebsiella infection 21.06 13.49 43 72742 19966 110496548
Euthyroid sick syndrome 20.97 13.49 6 72779 97 110516417
Transaminases increased 20.93 13.49 90 72695 63300 110453214
Large intestine anastomosis 20.80 13.49 6 72779 100 110516414
Dysgeusia 20.80 13.49 10 72775 69975 110446539
Respiratory rate decreased 20.68 13.49 23 72762 6235 110510279
Medical device site fistula 20.67 13.49 5 72780 40 110516474
Chest discomfort 20.66 13.49 53 72732 173795 110342719
Superinfection 20.47 13.49 22 72763 5741 110510773
Intensive care 20.46 13.49 15 72770 2364 110514150
Hypothermia 20.35 13.49 50 72735 26252 110490262
Injury 20.33 13.49 55 72730 177210 110339304
Mechanical ventilation complication 20.32 13.49 10 72775 761 110515753
Blood pressure fluctuation 20.31 13.49 12 72773 74812 110441702
Hot flush 20.30 13.49 9 72776 66027 110450487
Cystitis 20.30 13.49 9 72776 66027 110450487
Restlessness 20.24 13.49 82 72703 56177 110460337
Mechanical ventilation 20.12 13.49 17 72768 3290 110513224
Nephrogenic diabetes insipidus 20.10 13.49 15 72770 2430 110514084
Urinary tract infection 20.05 13.49 129 72656 326153 110190361
Cardiac output decreased 19.99 13.49 14 72771 2055 110514459
Adverse drug reaction 19.98 13.49 24 72761 105535 110410979
Haemoglobin decreased 19.90 13.49 90 72695 248637 110267877
Hip arthroplasty 19.87 13.49 6 72779 55807 110460707
Apnoeic attack 19.83 13.49 10 72775 802 110515712
Pseudocholinesterase deficiency 19.73 13.49 7 72778 232 110516282
Atrioventricular dissociation 19.69 13.49 8 72777 386 110516128
Hyperdynamic left ventricle 19.65 13.49 9 72776 583 110515931
Systolic dysfunction 19.59 13.49 19 72766 4396 110512118
Carbohydrate antigen 125 increased 19.55 13.49 15 72770 2532 110513982
Miosis 19.41 13.49 44 72741 21939 110494575
Extrapyramidal disorder 19.36 13.49 52 72733 28815 110487699
Axillary pain 19.35 13.49 15 72770 2571 110513943
Thrombosis 19.22 13.49 26 72759 108636 110407878
Shock haemorrhagic 19.21 13.49 50 72735 27197 110489317
Injection site pruritus 19.20 13.49 5 72780 51253 110465261
Live birth 19.07 13.49 11 72774 69473 110447041
Stevens-Johnson syndrome 19.02 13.49 71 72714 46830 110469684
Schizencephaly 18.98 13.49 3 72782 0 110516514
Defaecation urgency 18.96 13.49 26 72759 8721 110507793
Myocardial infarction 18.88 13.49 64 72721 192019 110324495
Surgery 18.88 13.49 65 72720 41218 110475296
Drug abuse 18.82 13.49 189 72596 177222 110339292
Blood magnesium decreased 18.76 13.49 41 72744 19955 110496559
Skin exfoliation 18.74 13.49 18 72767 87633 110428881
Cell death 18.65 13.49 21 72764 5770 110510744
Electrocardiogram repolarisation abnormality 18.47 13.49 14 72771 2321 110514193
Epileptic encephalopathy 18.40 13.49 9 72776 676 110515838
Vertigo 18.38 13.49 18 72767 86852 110429662
Angina pectoris 18.36 13.49 9 72776 62286 110454228
Left ventricular hypertrophy 18.34 13.49 32 72753 13212 110503302
Post procedural haemorrhage 18.34 13.49 35 72750 15477 110501037
Non-cardiogenic pulmonary oedema 18.18 13.49 13 72772 1971 110514543
Anticonvulsant drug level therapeutic 18.15 13.49 4 72781 20 110516494
Defect conduction intraventricular 17.96 13.49 9 72776 712 110515802
Language disorder 17.94 13.49 17 72768 3821 110512693
Central nervous system stimulation 17.88 13.49 5 72780 74 110516440
Drug withdrawal convulsions 17.88 13.49 14 72771 2435 110514079
Mental status changes 17.87 13.49 98 72687 76024 110440490
Pituitary apoplexy 17.84 13.49 7 72778 308 110516206
Liver function test 17.80 13.49 6 72779 170 110516344
Basal cell carcinoma 17.77 13.49 4 72781 45266 110471248
Liver injury 17.76 13.49 46 72739 150367 110366147
Renal impairment 17.76 13.49 196 72589 188249 110328265
Dyspnoea paroxysmal nocturnal 17.61 13.49 14 72771 2488 110514026
Hypertriglyceridaemia 17.34 13.49 35 72750 16119 110500395
Petit mal epilepsy 17.22 13.49 23 72762 7524 110508990
Retrograde amnesia 17.21 13.49 9 72776 778 110515736
Myocardial stunning 17.21 13.49 7 72778 339 110516175
Necrotising colitis 17.18 13.49 12 72773 1753 110514761
Bezoar 17.15 13.49 17 72768 4037 110512477
Coronary artery embolism 17.13 13.49 7 72778 343 110516171
Myotonic dystrophy 17.08 13.49 6 72779 193 110516321
Syncope 16.98 13.49 72 72713 202464 110314050
Poor feeding infant 16.96 13.49 6 72779 197 110516317
Encephalitis 16.96 13.49 38 72747 18801 110497713
Nephrocalcinosis 16.89 13.49 12 72773 1802 110514712
Gastrointestinal mucosa hyperaemia 16.88 13.49 8 72777 560 110515954
End-tidal CO2 decreased 16.82 13.49 5 72780 93 110516421
Quadriparesis 16.77 13.49 18 72767 4689 110511825
Laryngeal oedema 16.68 13.49 26 72759 9781 110506733
Distributive shock 16.66 13.49 20 72765 5884 110510630
Buttock injury 16.57 13.49 6 72779 211 110516303
Myoglobin blood increased 16.54 13.49 17 72768 4215 110512299
Atonic seizures 16.54 13.49 10 72775 1144 110515370
Pneumothorax 16.52 13.49 56 72729 35229 110481285
Haemophagocytic lymphohistiocytosis 16.50 13.49 52 72733 31507 110485007
Brain stem auditory evoked response abnormal 16.44 13.49 3 72782 4 110516510
Haemoperitoneum 16.44 13.49 19 72766 5369 110511145
Supraventricular tachycardia 16.39 13.49 44 72741 24378 110492136
Transient ischaemic attack 16.35 13.49 11 72774 63971 110452543
Burning sensation 16.26 13.49 13 72772 69199 110447315
Product contamination 16.21 13.49 12 72773 1919 110514595
Cardiovascular insufficiency 16.21 13.49 15 72770 3273 110513241
Cardiomegaly 16.16 13.49 49 72736 29081 110487433
Immunodeficiency 16.14 13.49 3 72782 38835 110477679
Subdural effusion 16.12 13.49 5 72780 108 110516406
Post procedural stroke 16.03 13.49 5 72780 110 110516404
Blood bromide increased 16.02 13.49 4 72781 37 110516477
Toxic skin eruption 15.94 13.49 47 72738 27468 110489046
Mouth ulceration 15.70 13.49 6 72779 48132 110468382
Herpes simplex viraemia 15.64 13.49 8 72777 661 110515853
Osteonecrosis of jaw 15.64 13.49 6 72779 48011 110468503
Prescribed underdose 15.62 13.49 12 72773 65162 110451352
Therapeutic product effect incomplete 15.59 13.49 220 72565 223585 110292929
Victim of homicide 15.45 13.49 6 72779 257 110516257
Thrombophlebitis 15.42 13.49 22 72763 7657 110508857
Transcranial electrical motor evoked potential monitoring abnormal 15.40 13.49 4 72781 44 110516470
Palmar-plantar erythrodysaesthesia syndrome 15.37 13.49 4 72781 41021 110475493
Hypertonia 15.31 13.49 23 72762 8383 110508131
Chemotherapeutic drug level above therapeutic 15.28 13.49 5 72780 129 110516385
Subcutaneous emphysema 15.14 13.49 13 72772 2571 110513943
Anticonvulsant drug level decreased 15.14 13.49 12 72773 2124 110514390
Myotonia 15.12 13.49 6 72779 272 110516242
Catheter site haemorrhage 15.10 13.49 19 72766 5861 110510653
Quadriplegia 15.09 13.49 16 72769 4111 110512403
Insomnia 15.09 13.49 158 72627 360432 110156082
Ejection fraction decreased 15.03 13.49 60 72725 40820 110475694
Feeling hot 14.93 13.49 23 72762 91083 110425431
Myocardial ischaemia 14.91 13.49 45 72740 26639 110489875
Trismus 14.90 13.49 20 72765 6576 110509938
Reduced facial expression 14.87 13.49 15 72770 3636 110512878
Accelerated idioventricular rhythm 14.84 13.49 6 72779 286 110516228
Gout 14.82 13.49 3 72782 36563 110479951
Drug chemical incompatibility 14.82 13.49 5 72780 142 110516372
Autonomic dysreflexia 14.74 13.49 7 72778 492 110516022
Heart alternation 14.59 13.49 3 72782 10 110516504
Electrocardiogram PR prolongation 14.47 13.49 11 72774 1832 110514682
Gastric ulcer perforation 14.41 13.49 12 72773 2276 110514238
Hyperexplexia 14.38 13.49 4 72781 58 110516456
Anaphylactoid reaction 14.36 13.49 20 72765 6806 110509708
Psychotic disorder 14.34 13.49 69 72716 50868 110465646
Agonal respiration 14.24 13.49 6 72779 318 110516196
Hypokalaemia 14.21 13.49 183 72602 182265 110334249
Eczema 14.15 13.49 16 72769 72277 110444237
Coma scale abnormal 14.12 13.49 24 72761 9702 110506812
Eye movement disorder 14.12 13.49 24 72761 9704 110506810
Hyporesponsive to stimuli 14.01 13.49 13 72772 2847 110513667
Long QT syndrome congenital 13.97 13.49 5 72780 170 110516344
Agitation postoperative 13.96 13.49 4 72781 65 110516449
Increased bronchial secretion 13.90 13.49 15 72770 3933 110512581
Gaze palsy 13.89 13.49 14 72771 3393 110513121
Teratoma 13.70 13.49 5 72780 180 110516334
Eye pain 13.65 13.49 8 72777 50091 110466423
Pancreatic enzymes abnormal 13.62 13.49 3 72782 15 110516499
Medical device battery replacement 13.62 13.49 3 72782 15 110516499
Blood pressure systolic increased 13.56 13.49 21 72764 82970 110433544
Urine output decreased 13.53 13.49 36 72749 19840 110496674
Hypovolaemia 13.50 13.49 38 72747 21636 110494878

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
Drug ineffective 65.68 43.62 42 223 1591 112097

Pharmacologic Action:

SourceCodeDescription
ATC N05CD08 NERVOUS SYSTEM
PSYCHOLEPTICS
HYPNOTICS AND SEDATIVES
Benzodiazepine derivatives
FDA CS M0002356 Benzodiazepines
MeSH PA D000759 Adjuvants, Anesthesia
MeSH PA D000777 Anesthetics
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D006993 Hypnotics and Sedatives
MeSH PA D011619 Psychotropic Drugs
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018682 GABA Agents
MeSH PA D018686 Anesthetics, Intravenous
MeSH PA D018757 GABA Modulators
FDA EPC N0000175694 Benzodiazepine
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:33231 antitubercular agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35488 central nervous system depressant
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35623 anticonvulsant
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:35717 sedative
CHEBI has role CHEBI:35718 antifungal agent
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:38068 antimalarial
CHEBI has role CHEBI:38869 general anaesthetic
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:50247 antidote
CHEBI has role CHEBI:50646 bone density conservation agent
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:50919 antiemetic
CHEBI has role CHEBI:51177 antitussive
CHEBI has role CHEBI:51371 muscle relaxant
CHEBI has role CHEBI:62868 hepatoprotective agent
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:64951 anti-HBV agent
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:68495 apoptosis inducer
CHEBI has role CHEBI:73336 vulnerary
CHEBI has role CHEBI:74518 anti-obesity agent
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:91016 GABA<small><sub>A</sub></small> receptor agonist
CHEBI has role CHEBI:145947 antiatherosclerotic agent

Related Drugs by ATC class:

N05CD Benzodiazepine derivatives 14 drugs
brotizolamcinolazepamdoxefazepamestazolamflunitrazepamflurazepamloprazolamlormetazepamnimetazepamnitrazepamquazepamremimazolam show all 14 →

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

DiseaseRelationSNOMED_IDDOID
Feeling agitated indication 24199005
Anxiety indication 48694002
General anesthesia indication 50697003
Sedation indication 72641008
Status epilepticus indication 230456007 DOID:1824
Conscious sedation indication 314271007
Local anesthesia indication 386761002
Sedation as Adjunct to Anesthesia indication
Induce Anterograde Amnesia indication
Sedation in Intubated Patients indication
Preoperative Anxiety indication
Insomnia off-label use 193462001
Cocaine-Associated Acute Ischemic Heart Disease off-label use
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Cirrhosis of liver contraindication 19943007 DOID:5082
Shock contraindication 27942005
End stage renal disease contraindication 46177005 DOID:784
Chronic heart failure contraindication 48447003
Pregnancy, function contraindication 289908002
Coma contraindication 371632003
Angle-closure glaucoma contraindication 392291006 DOID:13550
Hemodynamic instability contraindication 422773005
Peripheral Vasoconstriction contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 6.07 Basic
pKa2 2.36 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
5MG/SPRAY NAYZILAM UCB INC N211321 May 17, 2019 RX SPRAY NASAL 8217033 Jan. 18, 2028 ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENTS USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER
5MG/SPRAY NAYZILAM UCB INC N211321 May 17, 2019 RX SPRAY NASAL 9289432 Jan. 18, 2028 ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENTS USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER
5MG/SPRAY NAYZILAM UCB INC N211321 May 17, 2019 RX SPRAY NASAL 9687495 Jan. 18, 2028 ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENTS USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
5MG/SPRAY NAYZILAM UCB INC N211321 May 17, 2019 RX SPRAY NASAL May 17, 2026 ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENTS USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
GABA A receptor alpha-5/beta-2/gamma-3 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 8.26 WOMBAT-PK CHEMBL
GABA-A receptor alpha-1/beta-2/gamma-3 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 7.75 WOMBAT-PK CHEMBL
GABA A receptor alpha-3/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 8.44 WOMBAT-PK CHEMBL
GABA A receptor alpha-3/beta-2/gamma-3 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 7.61 WOMBAT-PK CHEMBL
GABA A receptor alpha-5/beta-3/gamma-3 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 8.26 WOMBAT-PK CHEMBL
GABA A receptor alpha-5/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 9.13 WOMBAT-PK CHEMBL
GABA-A receptor alpha-1/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 8.75 WOMBAT-PK CHEMBL
GABA-A receptor alpha-5/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 9.13 WOMBAT-PK CHEMBL
Multidrug resistance protein 1 Transporter Km 4.35 WOMBAT-PK
Cytochrome P450 3A4 Enzyme Km 6 WOMBAT-PK
Translocator protein Membrane receptor Ki 8.70 CHEMBL
Thyrotropin-releasing hormone receptor GPCR ANTAGONIST Ki 5.49 IUPHAR
GABA-A receptor; anion channel Ion channel Ki 8.70 CHEMBL

External reference:

IDSource
4019839 VUID
N0000147927 NUI
D00550 KEGG_DRUG
59467-96-8 SECONDARY_CAS_RN
4017813 VANDF
4019839 VANDF
C0026056 UMLSCUI
CHEBI:6931 CHEBI
08J PDB_CHEM_ID
CHEMBL655 ChEMBL_ID
CHEMBL1200420 ChEMBL_ID
DB00683 DRUGBANK_ID
D008874 MESH_DESCRIPTOR_UI
4192 PUBCHEM_CID
3342 IUPHAR_LIGAND_ID
4497 INN_ID
R60L0SM5BC UNII
203128 RXNORM
130935 MMSL
24970 MMSL
32073 MMSL
5114 MMSL
d00301 MMSL
001467 NDDF
004585 NDDF
26800000 SNOMEDCT_US
373476007 SNOMEDCT_US
84213009 SNOMEDCT_US
R60L0SM5BC INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-3566 SYRUP 2 mg ORAL ANDA 23 sections
Midazolam in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9379 INJECTION 1 mg INTRAVENOUS ANDA 28 sections
Midazolam in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9380 INJECTION 1 mg INTRAVENOUS ANDA 28 sections
MIDAZOLAM IN 0.8% SODIUM CHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0264-8002 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 27 sections
MIDAZOLAM IN 0.8% SODIUM CHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0264-8002 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 27 sections
MIDAZOLAM IN 0.8% SODIUM CHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0264-8005 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 27 sections
MIDAZOLAM IN 0.8% SODIUM CHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0264-8005 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 27 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0404-9780 INJECTION 1 mg INTRAMUSCULAR ANDA 15 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0404-9801 INJECTION 5 mg INTRAMUSCULAR ANDA 15 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0404-9801 INJECTION 5 mg INTRAMUSCULAR ANDA 15 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0404-9913 INJECTION 1 mg INTRAMUSCULAR ANDA 15 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0404-9913 INJECTION 1 mg INTRAMUSCULAR ANDA 15 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0404-9915 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 15 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0404-9915 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 15 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0404-9916 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 15 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0409-0001 INJECTION, SOLUTION 1 mg INTRAMUSCULAR ANDA 27 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0409-2305 INJECTION, SOLUTION 1 mg INTRAMUSCULAR ANDA 27 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0409-2305 INJECTION, SOLUTION 1 mg INTRAMUSCULAR ANDA 27 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0409-2308 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 27 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0409-2308 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 27 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0409-2587 INJECTION, SOLUTION 1 mg INTRAMUSCULAR ANDA 26 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0409-2596 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 26 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0574-0150 SYRUP 2 mg ORAL ANDA 24 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0641-6056 INJECTION 1 mg INTRAMUSCULAR ANDA 25 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0641-6057 INJECTION 1 mg INTRAMUSCULAR ANDA 25 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0641-6059 INJECTION 1 mg INTRAMUSCULAR ANDA 25 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0641-6060 INJECTION 5 mg INTRAMUSCULAR ANDA 25 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0641-6061 INJECTION 5 mg INTRAMUSCULAR ANDA 25 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0641-6063 INJECTION 5 mg INTRAMUSCULAR ANDA 25 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0641-6190 INJECTION 5 mg INTRAMUSCULAR ANDA 27 sections