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

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 344.76 16.00 159 29053 15074 63444736
Multiple-drug resistance 322.00 16.00 112 29100 5058 63454752
Serotonin syndrome 309.26 16.00 182 29030 28500 63431310
Hypotension 299.95 16.00 486 28726 272118 63187692
Cardiac arrest 255.62 16.00 261 28951 92284 63367526
Myoglobin urine present 207.69 16.00 52 29160 720 63459090
Anaphylactic reaction 198.21 16.00 195 29017 65905 63393905
Propofol infusion syndrome 195.22 16.00 52 29160 931 63458879
Toxic encephalopathy 175.31 16.00 77 29135 6502 63453308
Drug interaction 164.49 16.00 340 28872 228791 63231019
Fatigue 149.29 16.00 115 29097 887913 62571897
Drug ineffective 142.47 16.00 891 28321 1043874 62415936
Drug ineffective for unapproved indication 142.17 16.00 121 29091 33942 63425868
Joint swelling 132.62 16.00 4 29208 327662 63132148
Respiratory acidosis 130.10 16.00 63 29149 6652 63453158
Diabetes insipidus 130.00 16.00 48 29164 2577 63457233
Tachycardia 129.93 16.00 211 29001 117945 63341865
Metabolic acidosis 129.57 16.00 130 29082 44939 63414871
Seizure 126.16 16.00 222 28990 132412 63327398
Female genital tract fistula 125.94 16.00 64 29148 7495 63452315
Vaginal flatulence 122.89 16.00 49 29163 3244 63456566
Alopecia 121.04 16.00 9 29203 337527 63122283
Proctitis 120.58 16.00 56 29156 5385 63454425
Multiple organ dysfunction syndrome 119.75 16.00 139 29073 56613 63403197
Anaphylactic shock 115.45 16.00 92 29120 23541 63436269
Amylase increased 115.36 16.00 57 29155 6288 63453522
Labile blood pressure 112.32 16.00 39 29173 1750 63458060
Partial seizures 110.74 16.00 54 29158 5788 63454022
Blood creatine phosphokinase increased 110.73 16.00 100 29112 30330 63429480
Unwanted awareness during anaesthesia 107.26 16.00 26 29186 312 63459498
Generalised tonic-clonic seizure 106.86 16.00 96 29116 28920 63430890
Mitochondrial DNA mutation 106.45 16.00 27 29185 395 63459415
Encephalopathy 104.81 16.00 108 29104 38512 63421298
Circulatory collapse 104.17 16.00 84 29128 21854 63437956
Abdominal discomfort 103.37 16.00 13 29199 320872 63138938
Radiculopathy 98.99 16.00 57 29155 8554 63451256
Agitation 98.08 16.00 129 29083 59628 63400182
Swelling 96.85 16.00 8 29204 275370 63184440
Shock 95.14 16.00 82 29130 23381 63436429
Arthropathy 94.47 16.00 3 29209 234789 63225021
Frequent bowel movements 94.46 16.00 81 29131 22941 63436869
Intra-abdominal pressure increased 93.79 16.00 22 29190 227 63459583
Troponin increased 92.99 16.00 58 29154 10063 63449747
Bradycardia 89.05 16.00 137 29075 73090 63386720
Arthralgia 86.57 16.00 81 29131 569629 62890181
Oral candidiasis 85.07 16.00 76 29136 22722 63437088
Colitis 84.69 16.00 108 29104 48420 63411390
Anticholinergic syndrome 83.90 16.00 34 29178 2348 63457462
Unresponsive to stimuli 83.62 16.00 90 29122 33726 63426084
Systemic lupus erythematosus 82.87 16.00 3 29209 208915 63250895
Renal ischaemia 82.18 16.00 24 29188 609 63459201
Myoclonus 80.13 16.00 63 29149 15805 63444005
Drug intolerance 79.24 16.00 22 29190 308639 63151171
Respiratory failure 77.47 16.00 155 29057 101703 63358107
Respiratory depression 77.01 16.00 58 29154 13657 63446153
Peripheral swelling 76.08 16.00 15 29197 265927 63193883
Vaginal discharge 75.27 16.00 49 29163 9149 63450661
Pain 75.15 16.00 142 29070 740486 62719324
Systemic inflammatory response syndrome 74.91 16.00 41 29171 5580 63454230
Off label use 74.35 16.00 547 28665 673915 62785895
PCO2 increased 73.90 16.00 26 29186 1213 63458597
Apnoea 73.77 16.00 46 29166 7976 63451834
Fall 71.94 16.00 46 29166 392288 63067522
Oxygen saturation abnormal 71.06 16.00 34 29178 3495 63456315
Delirium 70.69 16.00 101 29111 50440 63409370
Ventricular hypokinesia 70.67 16.00 37 29175 4607 63455203
Pain in extremity 69.25 16.00 33 29179 331453 63128357
Pulseless electrical activity 68.84 16.00 43 29169 7478 63452332
Hepatic ischaemia 68.15 16.00 21 29191 643 63459167
Pneumatosis 67.72 16.00 19 29193 416 63459394
Colitis ulcerative 67.26 16.00 71 29141 26020 63433790
Necrosis ischaemic 66.80 16.00 22 29190 838 63458972
PO2 increased 66.33 16.00 22 29190 857 63458953
Delayed recovery from anaesthesia 65.06 16.00 21 29191 750 63459060
Blood pH decreased 64.80 16.00 29 29183 2558 63457252
CSF oligoclonal band present 64.68 16.00 18 29194 382 63459428
Blood gases abnormal 64.38 16.00 21 29191 776 63459034
Intestinal ischaemia 64.11 16.00 41 29171 7427 63452383
Blood lactate dehydrogenase increased 63.35 16.00 65 29147 23051 63436759
Blood potassium increased 62.37 16.00 58 29154 18251 63441559
Hepatic failure 61.65 16.00 79 29133 35577 63424233
Oxygen saturation decreased 60.52 16.00 129 29083 88456 63371354
Nasopharyngitis 60.08 16.00 21 29191 254236 63205574
Electrocardiogram QRS complex prolonged 59.58 16.00 36 29176 5902 63453908
Gene mutation 59.44 16.00 24 29188 1641 63458169
Contraindicated product administered 58.72 16.00 14 29198 217634 63242176
Weight increased 57.53 16.00 24 29188 260768 63199042
Diarrhoea 56.44 16.00 157 29055 715209 62744601
Blood lactic acid increased 56.16 16.00 37 29175 7049 63452761
Toxicity to various agents 55.47 16.00 243 28969 247007 63212803
Cardiogenic shock 53.87 16.00 53 29159 17879 63441931
Acute respiratory distress syndrome 53.60 16.00 60 29152 23474 63436336
Discomfort 53.31 16.00 7 29205 167367 63292443
Epilepsy 53.26 16.00 64 29148 27001 63432809
Renal impairment 52.84 16.00 122 29090 88233 63371577
Perforation 52.63 16.00 20 29192 1163 63458647
Anaesthetic complication neurological 52.59 16.00 14 29198 250 63459560
Anaesthetic complication 52.40 16.00 23 29189 1937 63457873
Foetal death 52.03 16.00 42 29170 10938 63448872
Haemodynamic instability 51.90 16.00 39 29173 9151 63450659
Pleocytosis 51.43 16.00 18 29194 827 63458983
Product dose omission issue 50.97 16.00 22 29190 234291 63225519
Neuromuscular block prolonged 50.84 16.00 16 29196 526 63459284
Sinusitis 49.75 16.00 21 29191 226632 63233178
Disseminated intravascular coagulation 49.38 16.00 52 29160 18999 63440811
Blood bicarbonate decreased 49.27 16.00 25 29187 2916 63456894
Altered state of consciousness 48.57 16.00 59 29153 25171 63434639
Brain oedema 48.41 16.00 45 29167 14150 63445660
Muscle relaxant therapy 47.86 16.00 12 29200 167 63459643
Ventricular extrasystoles 47.69 16.00 41 29171 11646 63448164
Dizziness 47.47 16.00 78 29134 429847 63029963
Epileptic aura 47.00 16.00 10 29202 63 63459747
Electroencephalogram abnormal 46.77 16.00 26 29186 3646 63456164
Nausea 45.95 16.00 220 28992 854251 62605559
Electrocardiogram ST segment elevation 45.15 16.00 26 29186 3901 63455909
Mydriasis 44.88 16.00 40 29172 11916 63447894
Bronchospasm 44.49 16.00 47 29165 17233 63442577
Posterior reversible encephalopathy syndrome 44.34 16.00 47 29165 17298 63442512
Oropharyngeal oedema 44.28 16.00 13 29199 336 63459474
Electrocardiogram ST segment depression 44.00 16.00 23 29189 2854 63456956
Anorectal ulcer 43.26 16.00 9 29203 50 63459760
Hepatorenal syndrome 43.16 16.00 20 29192 1912 63457898
Left ventricular dysfunction 42.82 16.00 39 29173 11949 63447861
Anaesthetic complication pulmonary 42.82 16.00 9 29203 53 63459757
Non-consummation 42.82 16.00 9 29203 53 63459757
Change in seizure presentation 41.82 16.00 13 29199 410 63459400
Arthritis 41.75 16.00 3 29209 115918 63343892
Cardiotoxicity 41.52 16.00 33 29179 8405 63451405
Diabetic macroangiopathy 41.03 16.00 10 29202 123 63459687
Malaise 40.95 16.00 81 29131 415873 63043937
Headache 40.79 16.00 152 29060 633089 62826721
Musculoskeletal stiffness 40.68 16.00 17 29195 184601 63275209
Patent ductus arteriosus 40.67 16.00 25 29187 4225 63455585
Intestinal infarction 40.49 16.00 16 29196 1034 63458776
Depressed level of consciousness 39.64 16.00 88 29124 61990 63397820
Hypoxia 39.59 16.00 86 29126 59706 63400104
Hepatic enzyme increased 39.44 16.00 22 29190 202306 63257504
Asthma 39.06 16.00 6 29206 127555 63332255
Ultrasound ovary abnormal 38.81 16.00 9 29203 88 63459722
Lower respiratory tract infection 38.79 16.00 7 29205 132300 63327510
Carcinoid crisis 38.61 16.00 11 29201 255 63459555
Unmasking of previously unidentified disease 38.08 16.00 15 29197 961 63458849
Hypernatraemia 37.96 16.00 30 29182 7579 63452231
Pseudopolyp 37.74 16.00 11 29201 277 63459533
Airway peak pressure increased 37.48 16.00 11 29201 284 63459526
Toxic epidermal necrolysis 37.44 16.00 52 29160 25282 63434528
Systolic dysfunction 37.12 16.00 17 29195 1582 63458228
Rectal haemorrhage 36.51 16.00 74 29138 48956 63410854
Sinus bradycardia 36.44 16.00 39 29173 14512 63445298
Arrhythmia 36.40 16.00 64 29148 38076 63421734
Stress cardiomyopathy 36.23 16.00 32 29180 9418 63450392
Contusion 36.10 16.00 12 29200 150032 63309778
Acute hepatic failure 35.51 16.00 43 29169 18284 63441526
Upper airway obstruction 35.34 16.00 13 29199 690 63459120
Macroglossia 35.31 16.00 13 29199 692 63459118
Sinus tachycardia 34.66 16.00 49 29163 24219 63435591
Hepatocellular injury 34.34 16.00 52 29160 27329 63432481
Hypertrophic cardiomyopathy 34.13 16.00 16 29196 1571 63458239
Acid base balance abnormal 34.05 16.00 10 29202 259 63459551
Device related sepsis 33.96 16.00 22 29190 4072 63455738
Alanine aminotransferase increased 33.91 16.00 115 29097 103655 63356155
Mixed liver injury 33.39 16.00 23 29189 4712 63455098
Intensive care unit acquired weakness 33.38 16.00 13 29199 808 63459002
Impaired healing 33.34 16.00 4 29208 102538 63357272
Back pain 32.93 16.00 44 29168 264101 63195709
Brain death 32.48 16.00 20 29192 3390 63456420
Acute coronary syndrome 32.42 16.00 31 29181 10095 63449715
Bulimia nervosa 32.35 16.00 11 29201 463 63459347
Epilepsy with myoclonic-atonic seizures 32.34 16.00 8 29204 105 63459705
Stevens-Johnson syndrome 32.17 16.00 48 29164 24902 63434908
Overdose 32.03 16.00 121 29091 114957 63344853
Encephalitis autoimmune 32.01 16.00 15 29197 1471 63458339
Asthenia 31.79 16.00 82 29130 383522 63076288
Abdominal pain upper 31.66 16.00 29 29183 206415 63253395
Infusion related reaction 31.53 16.00 40 29172 245481 63214329
Paradoxical drug reaction 31.26 16.00 21 29191 4131 63455679
Vulvovaginal candidiasis 31.21 16.00 19 29193 3156 63456654
Drug resistance 30.84 16.00 45 29167 22888 63436922
Hypersensitivity 30.53 16.00 55 29157 292630 63167180
Hypoaesthesia 30.45 16.00 20 29192 168373 63291437
Nail dystrophy 30.37 16.00 13 29199 1030 63458780
Stomatitis 30.19 16.00 13 29199 138712 63321098
Respiratory arrest 30.14 16.00 54 29158 32591 63427219
Electrocardiogram QT prolonged 30.02 16.00 77 29135 59453 63400357
Laryngeal stenosis 29.96 16.00 13 29199 1065 63458745
Neurotoxicity 29.92 16.00 38 29174 16952 63442858
Pseudomonas infection 29.76 16.00 31 29181 11182 63448628
Cardio-respiratory arrest 29.67 16.00 77 29135 59882 63399928
Intentional overdose 29.55 16.00 88 29124 74064 63385746
Tachyphylaxis 29.48 16.00 9 29203 267 63459543
Acidosis hyperchloraemic 29.43 16.00 10 29202 420 63459390
Tonic clonic movements 29.42 16.00 14 29198 1421 63458389
Clonus 29.17 16.00 21 29191 4615 63455195
Premature delivery 29.13 16.00 51 29161 30230 63429580
Muscle rigidity 29.11 16.00 31 29181 11469 63448341
Local anaesthetic systemic toxicity 28.83 16.00 12 29200 887 63458923
Dyschezia 28.56 16.00 16 29196 2278 63457532
Product administered to patient of inappropriate age 28.19 16.00 18 29194 3250 63456560
Hyperammonaemic encephalopathy 27.67 16.00 16 29196 2418 63457392
Gastrointestinal mucosa hyperaemia 27.58 16.00 8 29204 198 63459612
Drug reaction with eosinophilia and systemic symptoms 27.52 16.00 53 29159 33783 63426027
Oliguria 27.52 16.00 27 29185 9074 63450736
Blood cholesterol increased 27.50 16.00 5 29207 94027 63365783
Gastrointestinal scarring 27.27 16.00 9 29203 345 63459465
Palpitations 27.15 16.00 9 29203 112761 63347049
Procedural vomiting 27.15 16.00 10 29202 533 63459277
Anuria 26.88 16.00 31 29181 12520 63447290
Psoriasis 26.82 16.00 4 29208 86953 63372857
Intensive care unit delirium 26.73 16.00 6 29206 50 63459760
Bronchitis 26.72 16.00 12 29200 124923 63334887
Myoglobin blood increased 26.67 16.00 13 29199 1392 63458418
Pituitary apoplexy 26.24 16.00 7 29205 126 63459684
Adverse drug reaction 26.19 16.00 3 29209 79711 63380099
Gastrointestinal disorder 25.96 16.00 14 29198 131225 63328585
Procedural hypotension 25.60 16.00 12 29200 1178 63458632
Therapeutic product effect decreased 25.29 16.00 31 29181 193156 63266654
Hyperaesthesia 25.07 16.00 26 29186 9332 63450478
Restlessness 25.02 16.00 47 29165 29406 63430404
Tachypnoea 24.80 16.00 35 29177 17267 63442543
Loss of personal independence in daily activities 24.80 16.00 7 29205 97283 63362527
Musculoskeletal pain 24.74 16.00 6 29206 92271 63367539
Left ventricular hypertrophy 24.48 16.00 20 29192 5295 63454515
Electrocardiogram repolarisation abnormality 24.44 16.00 12 29200 1305 63458505
Acute respiratory failure 24.44 16.00 51 29161 34434 63425376
Pruritus 24.37 16.00 85 29127 361368 63098442
Euthyroid sick syndrome 24.24 16.00 6 29206 79 63459731
Lactic acidosis 24.13 16.00 54 29158 38233 63421577
Neurodevelopmental disorder 24.10 16.00 7 29205 174 63459636
Paralysis 23.85 16.00 26 29186 9874 63449936
Ventricular tachycardia 23.73 16.00 37 29175 19942 63439868
Rash 23.72 16.00 156 29056 560715 62899095
Pulmonary hypertensive crisis 23.54 16.00 8 29204 336 63459474
Delayed graft function 23.44 16.00 11 29201 1082 63458728
Drug-induced liver injury 23.44 16.00 55 29157 40167 63419643
Infection parasitic 23.38 16.00 8 29204 343 63459467
Myalgia 23.15 16.00 20 29192 146509 63313301
Myocardial ischaemia 23.02 16.00 29 29183 12830 63446980
Procedural pain 22.96 16.00 38 29174 21531 63438279
Acidosis 22.82 16.00 27 29185 11206 63448604
Irritable bowel syndrome 22.81 16.00 5 29207 82407 63377403
Sinus arrest 22.66 16.00 13 29199 1936 63457874
Atrioventricular dissociation 22.57 16.00 7 29205 219 63459591
Ill-defined disorder 22.55 16.00 5 29207 81750 63378060
Sleep disorder 22.47 16.00 5 29207 81561 63378249
Axillary pain 22.45 16.00 13 29199 1970 63457840
Hepatitis acute 22.06 16.00 24 29188 9096 63450714
Wrong product administered 21.97 16.00 20 29192 6121 63453689
Seizure cluster 21.93 16.00 7 29205 241 63459569
Coagulopathy 21.61 16.00 36 29176 20508 63439302
Haematemesis 21.57 16.00 45 29167 30367 63429443
Catheter site haemorrhage 21.40 16.00 15 29197 3160 63456650
Product use in unapproved indication 21.15 16.00 148 29064 178932 63280878
Mobility decreased 21.08 16.00 15 29197 121144 63338666
Dry mouth 21.00 16.00 5 29207 77858 63381952
Post procedural stroke 20.94 16.00 5 29207 56 63459754
Blood magnesium decreased 20.88 16.00 28 29184 13170 63446640
Encephalitis 20.84 16.00 23 29189 8857 63450953
Gaze palsy 20.71 16.00 11 29201 1409 63458401
Apnoeic attack 20.69 16.00 7 29205 290 63459520
Hypovolaemia 20.60 16.00 25 29187 10648 63449162
Symptom masked 20.59 16.00 9 29203 750 63459060
Nephrocalcinosis 20.54 16.00 10 29202 1068 63458742
Exposure during pregnancy 20.43 16.00 132 29080 155415 63304395
Gait disturbance 20.38 16.00 33 29179 183145 63276665
Granulomatous liver disease 20.38 16.00 9 29203 769 63459041
White matter lesion 20.34 16.00 12 29200 1883 63457927
Methaemoglobinaemia 20.15 16.00 13 29199 2390 63457420
Weight decreased 20.09 16.00 63 29149 276735 63183075
Hypoventilation 20.05 16.00 17 29195 4737 63455073
Procedural complication 20.02 16.00 18 29194 5421 63454389
Resuscitation 19.97 16.00 10 29202 1134 63458676
Chronic sinusitis 19.94 16.00 27 29185 12816 63446994
Haematochezia 19.88 16.00 62 29150 53482 63406328
Coma 19.86 16.00 70 29142 64294 63395516
Laryngospasm 19.70 16.00 14 29198 3014 63456796
Hyperdynamic left ventricle 19.59 16.00 6 29206 180 63459630
Hypokalaemia 19.53 16.00 97 29115 103707 63356103
Coronary artery embolism 19.40 16.00 6 29206 186 63459624
Therapeutic product effect prolonged 19.39 16.00 7 29205 352 63459458
Dyspnoea 19.29 16.00 203 29009 661110 62798700
Infection 18.95 16.00 49 29163 229124 63230686
Premature baby 18.76 16.00 34 29178 20701 63439109
Airway complication of anaesthesia 18.70 16.00 6 29206 210 63459600
Respiratory rate increased 18.67 16.00 27 29185 13621 63446189
White blood cell count decreased 18.54 16.00 22 29190 139082 63320728
C-reactive protein decreased 18.51 16.00 9 29203 958 63458852
Muscle spasms 18.46 16.00 27 29185 156123 63303687
Sepsis 18.34 16.00 127 29085 152996 63306814
Hypotonia 18.33 16.00 22 29190 9263 63450547
Ventricular dysfunction 18.23 16.00 13 29199 2815 63456995
Tonsillar hypertrophy 18.21 16.00 9 29203 992 63458818
Bronchopulmonary dysplasia 18.12 16.00 7 29205 426 63459384
Large intestinal ulcer 18.09 16.00 14 29198 3430 63456380
Pulmonary oedema 18.08 16.00 61 29151 54812 63404998
Intermittent claudication 18.06 16.00 11 29201 1828 63457982
Burkholderia test positive 17.96 16.00 6 29206 239 63459571
Inappropriate schedule of product administration 17.92 16.00 13 29199 103952 63355858
Coronary artery bypass 17.88 16.00 12 29200 2357 63457453
Foetal exposure during pregnancy 17.86 16.00 43 29169 31919 63427891
Stridor 17.85 16.00 14 29198 3496 63456314
Renal infarct 17.76 16.00 10 29202 1437 63458373
Drug level below therapeutic 17.71 16.00 16 29196 4850 63454960
Septic shock 17.66 16.00 69 29143 66560 63393250
Post procedural haemorrhage 17.61 16.00 20 29192 7944 63451866
Maternal exposure during delivery 17.43 16.00 10 29202 1490 63458320
Immunosuppressant drug level increased 17.41 16.00 14 29198 3624 63456186
Hypochloraemia 17.17 16.00 11 29201 1998 63457812
Abdominal rigidity 17.09 16.00 11 29201 2013 63457797
Gastrointestinal vascular malformation 17.08 16.00 4 29208 41 63459769
Ventricular fibrillation 17 16.00 24 29188 11843 63447967
Influenza 16.98 16.00 15 29197 108707 63351103
Cholestasis 16.88 16.00 40 29172 29394 63430416
Selective eating disorder 16.86 16.00 11 29201 2061 63457749
Oedema peripheral 16.86 16.00 39 29173 189472 63270338
Neonatal seizure 16.85 16.00 7 29205 515 63459295
Epileptic encephalopathy 16.83 16.00 6 29206 291 63459519
Neuromuscular blockade 16.81 16.00 6 29206 292 63459518
Injection site pain 16.80 16.00 21 29191 129779 63330031
Extremity necrosis 16.75 16.00 10 29202 1603 63458207
Hyperammonaemia 16.72 16.00 16 29196 5216 63454594
Hyperthermia malignant 16.68 16.00 8 29204 826 63458984
Influenza like illness 16.68 16.00 5 29207 66819 63392991
Therapeutic product effect variable 16.51 16.00 9 29203 1214 63458596
Migraine 16.45 16.00 14 29198 103332 63356478
Gastrooesophageal reflux disease 16.43 16.00 12 29200 95627 63364183
Rash morbilliform 16.35 16.00 13 29199 3312 63456498
Cytokine release syndrome 16.29 16.00 26 29186 14288 63445522
Teratoma 16.29 16.00 5 29207 151 63459659
Rapid eye movement sleep behaviour disorder 16.28 16.00 6 29206 320 63459490
Vasoplegia syndrome 16.27 16.00 10 29202 1689 63458121
Pneumonia fungal 16.15 16.00 16 29196 5439 63454371
Tracheal injury 16.14 16.00 4 29208 53 63459757
Anaphylactoid shock 16.09 16.00 6 29206 331 63459479
Procedural intestinal perforation 16.04 16.00 5 29207 159 63459651

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
Status epilepticus 265.26 14.33 149 27285 12465 34917032
Drug ineffective 229.47 14.33 830 26604 455921 34473576
Hyperthermia malignant 184.29 14.33 68 27366 2109 34927388
Hypotension 183.91 14.33 481 26953 221168 34708329
Drug reaction with eosinophilia and systemic symptoms 170.47 14.33 167 27267 32845 34896652
Multiple-drug resistance 161.68 14.33 80 27354 5159 34924338
Cardiac arrest 158.10 14.33 276 27158 95883 34833614
Anaphylactic reaction 142.31 14.33 150 27284 32151 34897346
Drug ineffective for unapproved indication 137.65 14.33 128 27306 23587 34905910
Bradycardia 133.81 14.33 224 27210 75194 34854303
Serotonin syndrome 130.24 14.33 115 27319 19818 34909679
Propofol infusion syndrome 119.42 14.33 40 27394 926 34928571
Diabetes insipidus 109.43 14.33 51 27383 2877 34926620
Myoclonus 104.35 14.33 89 27345 14636 34914861
Respiratory failure 103.72 14.33 249 27185 108323 34821174
Intensive care unit acquired weakness 101.60 14.33 36 27398 991 34928506
Hypoxia 100.83 14.33 166 27268 54929 34874568
Sedation complication 99.04 14.33 41 27393 1736 34927761
Fatigue 97.23 14.33 89 27345 370564 34558933
Metabolic acidosis 95.74 14.33 143 27291 43537 34885960
Anaphylactic shock 94.34 14.33 87 27347 15854 34913643
Respiratory depression 91.01 14.33 86 27348 16159 34913338
Delirium 89.33 14.33 139 27295 43852 34885645
Rhabdomyolysis 83.81 14.33 173 27261 67990 34861507
Off label use 81.14 14.33 584 26850 418940 34510557
Coma 78.71 14.33 134 27300 45544 34883953
Generalised tonic-clonic seizure 75.40 14.33 88 27346 21086 34908411
Diarrhoea 75.25 14.33 119 27315 389793 34539704
Dizziness 73.58 14.33 40 27394 218481 34711016
Tachycardia 73.05 14.33 187 27247 84585 34844912
Multiple organ dysfunction syndrome 71.33 14.33 174 27260 76392 34853105
Autonomic nervous system imbalance 70.04 14.33 36 27398 2515 34926982
Agitation 69.74 14.33 145 27289 57254 34872243
Nausea 69.15 14.33 100 27334 339808 34589689
Product dose omission issue 68.91 14.33 7 27427 119704 34809793
Brain oedema 64.09 14.33 66 27368 13755 34915742
Respiratory acidosis 63.51 14.33 43 27391 5007 34924490
Headache 61.54 14.33 41 27393 200594 34728903
Acute respiratory distress syndrome 61.19 14.33 88 27346 25881 34903616
Electroencephalogram abnormal 59.58 14.33 32 27402 2446 34927051
Unresponsive to stimuli 57.18 14.33 88 27346 27481 34902016
Delayed recovery from anaesthesia 56.85 14.33 22 27412 779 34928718
Toxic epidermal necrolysis 56.43 14.33 77 27357 21569 34907928
Haemodynamic instability 56.38 14.33 52 27382 9471 34920026
Stress cardiomyopathy 56.36 14.33 29 27405 2030 34927467
Hypercapnia 55.35 14.33 37 27397 4218 34925279
Arthralgia 54.52 14.33 33 27401 170008 34759489
Seizure like phenomena 54.28 14.33 21 27413 743 34928754
Acidosis hyperchloraemic 53.40 14.33 18 27416 425 34929072
Drug interaction 53.35 14.33 331 27103 225615 34703882
Depressed level of consciousness 52.93 14.33 109 27325 42732 34886765
Electrocardiogram ST segment elevation 52.88 14.33 39 27395 5199 34924298
Necrosis ischaemic 52.17 14.33 16 27418 276 34929221
Partial seizures 51.60 14.33 37 27397 4723 34924774
Septic shock 50.41 14.33 147 27287 71687 34857810
Toxicity to various agents 50.12 14.33 298 27136 200064 34729433
Hyperthermia 49.92 14.33 51 27383 10526 34918971
Anaesthetic complication neurological 49.82 14.33 16 27418 323 34929174
Hypoventilation 47.60 14.33 31 27403 3383 34926114
Seizure 47.35 14.33 185 27249 104672 34824825
Sedation 46.32 14.33 69 27365 20937 34908560
Product administered to patient of inappropriate age 46.17 14.33 30 27404 3261 34926236
Behaviour disorder 46.10 14.33 35 27399 4875 34924622
Shock 45.74 14.33 74 27360 24105 34905392
Pain in extremity 44.24 14.33 22 27412 126491 34803006
Catatonia 43.21 14.33 34 27400 4991 34924506
Peripheral swelling 42.69 14.33 5 27429 76536 34852961
COVID-19 pneumonia 42.18 14.33 59 27375 16908 34912589
Hyperammonaemia 42.09 14.33 37 27397 6330 34923167
Hypertransaminasaemia 42.00 14.33 35 27399 5571 34923926
Myalgia 41.19 14.33 8 27426 84102 34845395
Laryngospasm 40.42 14.33 21 27413 1500 34927997
Anaesthetic complication 40.28 14.33 19 27415 1101 34928396
Dyskinesia 40.24 14.33 67 27367 22346 34907151
Mucosal ulceration 39.27 14.33 18 27416 977 34928520
Back pain 38.51 14.33 24 27410 121765 34807732
Dyspnoea 37.77 14.33 160 27274 376622 34552875
Intestinal ischaemia 37.55 14.33 38 27396 7756 34921741
Asthenia 37.40 14.33 86 27348 245165 34684332
Acidosis 36.49 14.33 44 27390 10901 34918596
Pulseless electrical activity 36.29 14.33 36 27398 7175 34922322
Rash maculo-papular 35.85 14.33 73 27361 28378 34901119
Joint swelling 35.78 14.33 3 27431 59887 34869610
Oxygen saturation decreased 35.71 14.33 108 27326 53710 34875787
Burkholderia test positive 35.71 14.33 17 27417 1006 34928491
Kounis syndrome 35.44 14.33 23 27411 2495 34927002
Herpes simplex viraemia 35.21 14.33 9 27425 76 34929421
Intensive care 34.33 14.33 14 27420 570 34928927
Coagulopathy 33.99 14.33 58 27376 19731 34909766
Death 33.48 14.33 180 27254 397869 34531628
Long QT syndrome 33.19 14.33 23 27411 2780 34926717
Corneal reflex decreased 33.13 14.33 10 27424 163 34929334
Respiratory arrest 33.05 14.33 70 27364 27973 34901524
Apnoea 33.03 14.33 33 27401 6631 34922866
Overdose 32.80 14.33 150 27284 90909 34838588
Pruritus 32.65 14.33 38 27396 141943 34787554
Dehydration 31.85 14.33 33 27401 129936 34799561
Fall 31.84 14.33 70 27364 202815 34726682
Epilepsy 31.77 14.33 59 27375 21436 34908061
Post procedural hypotension 31.36 14.33 8 27426 67 34929430
Artery dissection 31.35 14.33 9 27425 122 34929375
Blood lactic acid increased 30.95 14.33 32 27402 6696 34922801
Superinfection 30.61 14.33 21 27413 2498 34926999
Nasopharyngitis 29.67 14.33 9 27425 69959 34859538
Anticonvulsant drug level below therapeutic 29.67 14.33 13 27421 634 34928863
Brain death 29.41 14.33 21 27413 2662 34926835
Drug withdrawal syndrome 28.76 14.33 54 27380 19780 34909717
Abdominal discomfort 28.64 14.33 6 27428 59829 34869668
Misleading laboratory test result 28.60 14.33 6 27428 18 34929479
Encephalitis autoimmune 28.60 14.33 13 27421 692 34928805
White blood cell count decreased 28.55 14.33 20 27414 95425 34834072
Leukocytosis 28.27 14.33 60 27374 24005 34905492
Myocardial infarction 28.27 14.33 32 27402 121053 34808444
Trigemino-cardiac reflex 27.92 14.33 9 27425 184 34929313
Electrocardiogram QRS complex prolonged 27.57 14.33 26 27408 4868 34924629
Product use in unapproved indication 27.55 14.33 172 27262 117327 34812170
Weight decreased 27.51 14.33 61 27373 176240 34753257
Coma neonatal 27.47 14.33 6 27428 23 34929474
Pain 27.14 14.33 77 27357 204598 34724899
Muscle rigidity 26.78 14.33 37 27397 10481 34919016
Diabetes mellitus 26.29 14.33 3 27431 46870 34882627
Intracranial pressure increased 26.18 14.33 23 27411 3932 34925565
Neuromuscular block prolonged 26.04 14.33 11 27423 490 34929007
Cholestasis 25.86 14.33 62 27372 26886 34902611
Malignant catatonia 25.77 14.33 9 27425 237 34929260
Circulatory collapse 25.35 14.33 53 27381 20985 34908512
Drug resistance 25.26 14.33 60 27374 25867 34903630
Hepatitis fulminant 25.03 14.33 23 27411 4167 34925330
Haemophagocytic lymphohistiocytosis 24.93 14.33 40 27394 12933 34916564
Vomiting 24.23 14.33 106 27328 247515 34681982
Neuroleptic malignant syndrome 23.77 14.33 47 27387 17887 34911610
Periorbital swelling 23.51 14.33 11 27423 626 34928871
Liver function test 23.44 14.33 6 27428 51 34929446
Dissociative disorder 23.39 14.33 10 27424 459 34929038
Laryngomalacia 23.14 14.33 9 27425 323 34929174
Upper airway obstruction 23.05 14.33 11 27423 654 34928843
Hyporesponsive to stimuli 23.03 14.33 13 27421 1095 34928402
Tachypnoea 23.01 14.33 47 27387 18305 34911192
Areflexia 22.86 14.33 19 27415 3012 34926485
Hyperammonaemic encephalopathy 22.78 14.33 17 27417 2307 34927190
Large intestine anastomosis 22.75 14.33 6 27428 58 34929439
Procedural complication 22.70 14.33 22 27412 4261 34925236
Cyanosis 22.70 14.33 38 27396 12726 34916771
Malaise 22.42 14.33 73 27361 185752 34743745
Ventricular tachycardia 22.20 14.33 58 27376 26521 34902976
Defect conduction intraventricular 22.15 14.33 9 27425 363 34929134
Cardiac failure congestive 21.71 14.33 20 27414 83250 34846247
Blood pressure decreased 21.70 14.33 89 27345 51426 34878071
Odynophagia 21.42 14.33 24 27410 5497 34924000
Neuromuscular blockade 21.32 14.33 8 27426 260 34929237
Hospitalisation 21.26 14.33 9 27425 56893 34872604
Weight increased 21.26 14.33 25 27409 93008 34836489
Haemoglobin decreased 21.21 14.33 39 27395 120733 34808764
Cardiogenic shock 21.13 14.33 57 27377 26561 34902936
Mixed dementia 21.04 14.33 8 27426 270 34929227
Neurological examination abnormal 20.98 14.33 8 27426 272 34929225
Mumps 20.93 14.33 6 27428 81 34929416
Illusion 20.78 14.33 11 27423 816 34928681
Encephalopathy 20.77 14.33 68 27366 35251 34894246
Bronchospasm 20.50 14.33 33 27401 10698 34918799
Urinary bladder rupture 20.47 14.33 6 27428 88 34929409
Respiratory rate decreased 20.36 14.33 16 27418 2343 34927154
Clonus 20.25 14.33 17 27417 2733 34926764
Sinusitis 20.13 14.33 4 27430 41398 34888099
Medical device site fistula 19.91 14.33 5 27429 39 34929458
Anaemia 19.83 14.33 105 27329 233230 34696267
Disease progression 19.78 14.33 34 27400 108043 34821454
Decreased appetite 19.62 14.33 66 27368 166326 34763171
Stupor 19.51 14.33 17 27417 2874 34926623
Dyspnoea paroxysmal nocturnal 19.41 14.33 13 27421 1486 34928011
Neutropenia 19.31 14.33 61 27373 156717 34772780
Ileus 19.22 14.33 41 27393 16458 34913039
Respiratory disorder 19.22 14.33 45 27389 19219 34910278
Eosinophilia 18.69 14.33 54 27380 26168 34903329
Respiratory distress 18.63 14.33 66 27368 35599 34893898
Aggression 18.58 14.33 70 27364 38894 34890603
Heart alternation 18.45 14.33 3 27431 0 34929497
Nephrogenic diabetes insipidus 18.43 14.33 12 27422 1309 34928188
Phaeochromocytoma crisis 18.13 14.33 5 27429 58 34929439
Drug withdrawal syndrome neonatal 18.08 14.33 18 27416 3601 34925896
Atonic urinary bladder 17.80 14.33 4 27430 18 34929479
Constipation 17.79 14.33 52 27382 136930 34792567
Myotonic dystrophy 17.75 14.33 6 27428 143 34929354
Systemic inflammatory response syndrome 17.68 14.33 24 27410 6685 34922812
Hypotonia 17.60 14.33 26 27408 7827 34921670
Nystagmus 17.45 14.33 20 27414 4695 34924802
Hypernatraemia 17.45 14.33 27 27407 8463 34921034
Airway complication of anaesthesia 17.44 14.33 6 27428 151 34929346
Arthrofibrosis 17.27 14.33 5 27429 70 34929427
Pupil fixed 17.26 14.33 13 27421 1788 34927709
Hypoaesthesia 16.93 14.33 14 27420 61430 34868067
Periventricular haemorrhage neonatal 16.84 14.33 4 27430 24 34929473
Bronchitis 16.73 14.33 6 27428 41957 34887540
Endotracheal intubation 16.73 14.33 16 27418 3049 34926448
Euthanasia 16.70 14.33 4 27430 25 34929472
Postresuscitation encephalopathy 16.70 14.33 4 27430 25 34929472
Electrocardiogram QT prolonged 16.66 14.33 70 27364 40882 34888615
Angle closure glaucoma 16.64 14.33 10 27424 947 34928550
Product use issue 16.37 14.33 95 27339 63121 34866376
Neuropathy peripheral 16.35 14.33 25 27409 83238 34846259
Hyperaesthesia 16.07 14.33 19 27415 4611 34924886
Haematuria traumatic 16.05 14.33 6 27428 193 34929304
Thrombosis 15.85 14.33 10 27424 50448 34879049
Fear 15.79 14.33 29 27405 10447 34919050
Administration related reaction 15.71 14.33 5 27429 98 34929399
Nervous system disorder 15.64 14.33 35 27399 14508 34914989
Hyperexplexia 15.63 14.33 4 27430 34 34929463
Asthma 15.54 14.33 7 27427 42649 34886848
Paradoxical drug reaction 15.52 14.33 16 27418 3335 34926162
Catecholamine crisis 15.52 14.33 4 27430 35 34929462
Parkinsonism 15.51 14.33 25 27409 8113 34921384
Abdominal pain upper 15.50 14.33 20 27414 71470 34858027
Acute kidney injury 15.49 14.33 330 27104 304658 34624839
Endotracheal intubation complication 15.23 14.33 7 27427 382 34929115
Reversal of sedation 15.16 14.33 3 27431 6 34929491
Dyspepsia 15.08 14.33 5 27429 36727 34892770
Aspiration 15.02 14.33 31 27403 12163 34917334
Product packaging confusion 14.95 14.33 4 27430 41 34929456
Chronic obstructive pulmonary disease 14.95 14.33 10 27424 48908 34880589
Bezoar 14.90 14.33 10 27424 1147 34928350
Hypertriglyceridaemia 14.82 14.33 25 27409 8423 34921074
Neurotoxicity 14.73 14.33 39 27395 17971 34911526
Clonic convulsion 14.49 14.33 8 27426 646 34928851
Dry mouth 14.48 14.33 3 27431 30162 34899335
Oedema peripheral 14.48 14.33 47 27387 119765 34809732
Hypoglycaemia 14.38 14.33 13 27421 54627 34874870
Chills 14.37 14.33 26 27408 81017 34848480

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 565.57 13.98 291 51461 24750 79667886
Hypotension 426.62 13.98 904 50848 439413 79253223
Multiple-drug resistance 399.17 13.98 166 51586 8642 79683994
Cardiac arrest 383.90 13.98 514 51238 171582 79521054
Serotonin syndrome 382.60 13.98 280 51472 44747 79647889
Drug ineffective 366.61 13.98 1524 50228 1079389 78613247
Anaphylactic reaction 311.30 13.98 325 51427 83418 79609218
Propofol infusion syndrome 306.44 13.98 93 51659 1890 79690746
Drug ineffective for unapproved indication 250.38 13.98 231 51521 51007 79641629
Diabetes insipidus 238.29 13.98 99 51653 5138 79687498
Metabolic acidosis 211.11 13.98 264 51488 82265 79610371
Anaphylactic shock 203.01 13.98 176 51576 35820 79656816
Hyperthermia malignant 202.89 13.98 75 51677 2842 79689794
Fatigue 201.37 13.98 185 51567 929542 78763094
Bradycardia 193.50 13.98 329 51423 135228 79557408
Tachycardia 191.43 13.98 382 51370 177386 79515250
Drug interaction 187.08 13.98 643 51109 414540 79278096
Drug reaction with eosinophilia and systemic symptoms 184.60 13.98 218 51534 64026 79628610
Respiratory acidosis 177.43 13.98 103 51649 11097 79681539
Myoclonus 176.03 13.98 145 51607 27515 79665121
Respiratory failure 173.89 13.98 371 51381 180540 79512096
Multiple organ dysfunction syndrome 169.16 13.98 290 51462 119956 79572680
Joint swelling 168.26 13.98 4 51748 288642 79403994
Myoglobin urine present 161.82 13.98 48 51704 899 79691737
Arthralgia 160.14 13.98 86 51666 571717 79120919
Agitation 157.01 13.98 253 51499 99462 79593174
Respiratory depression 147.57 13.98 131 51621 27499 79665137
Hypoxia 143.88 13.98 248 51504 102995 79589641
Generalised tonic-clonic seizure 143.00 13.98 159 51593 43751 79648885
Partial seizures 138.08 13.98 81 51671 8897 79683739
Off label use 137.31 13.98 1031 50721 906184 78786452
Unresponsive to stimuli 137.12 13.98 175 51577 55613 79637023
Seizure 136.16 13.98 346 51406 188488 79504148
Delirium 134.96 13.98 216 51536 84411 79608225
Intensive care unit acquired weakness 131.87 13.98 49 51703 1884 79690752
Diarrhoea 130.51 13.98 233 51519 880256 78812380
Peripheral swelling 125.87 13.98 14 51738 269603 79423033
Nausea 124.93 13.98 273 51479 956923 78735713
Pain 124.58 13.98 165 51587 703637 78988999
Shock 123.79 13.98 147 51605 43401 79649235
Dizziness 118.12 13.98 101 51651 526340 79166296
Haemodynamic instability 116.65 13.98 94 51658 17288 79675348
Circulatory collapse 115.16 13.98 132 51620 37536 79655100
Abdominal discomfort 114.59 13.98 14 51738 250713 79441923
Necrosis ischaemic 114.10 13.98 38 51714 1052 79691584
Pain in extremity 113.97 13.98 47 51705 364491 79328145
Alopecia 113.24 13.98 10 51742 231345 79461291
Headache 111.89 13.98 157 51595 653615 79039021
Anaesthetic complication 110.02 13.98 48 51704 2811 79689825
Delayed recovery from anaesthesia 108.99 13.98 41 51711 1632 79691004
Intestinal ischaemia 104.75 13.98 79 51673 13191 79679445
Apnoea 104.38 13.98 75 51677 11629 79681007
Toxic encephalopathy 103.62 13.98 74 51678 11366 79681270
Fall 101.71 13.98 100 51652 487529 79205107
Mitochondrial DNA mutation 101.13 13.98 28 51724 405 79692231
Acute respiratory distress syndrome 100.13 13.98 133 51619 43934 79648702
Electrocardiogram ST segment elevation 99.14 13.98 64 51688 8333 79684303
Brain oedema 99.10 13.98 101 51651 25162 79667474
Anaesthetic complication neurological 98.64 13.98 30 51722 614 79692022
Drug intolerance 98.49 13.98 25 51727 264094 79428542
Rhabdomyolysis 98.41 13.98 211 51541 102920 79589716
Encephalopathy 97.95 13.98 165 51587 67232 79625404
Pulseless electrical activity 95.92 13.98 77 51675 14083 79678553
Product dose omission issue 93.12 13.98 23 51729 247514 79445122
Labile blood pressure 90.54 13.98 39 51713 2214 79690422
Nasopharyngitis 89.11 13.98 27 51725 253854 79438782
Depressed level of consciousness 89.07 13.98 195 51557 96457 79596179
Swelling 87.87 13.98 17 51735 216694 79475942
Toxicity to various agents 85.57 13.98 516 51236 421024 79271612
Unwanted awareness during anaesthesia 85.06 13.98 23 51729 303 79692333
Toxic epidermal necrolysis 84.03 13.98 123 51629 44458 79648178
Intra-abdominal pressure increased 83.71 13.98 22 51730 258 79692378
Blood lactic acid increased 83.57 13.98 68 51684 12676 79679960
Systemic inflammatory response syndrome 83.36 13.98 65 51687 11400 79681236
Oxygen saturation decreased 82.30 13.98 226 51526 128821 79563815
Electroencephalogram abnormal 80.87 13.98 48 51704 5386 79687250
Coma 80.49 13.98 192 51560 100457 79592179
Troponin increased 79.22 13.98 79 51673 19176 79673460
Acidosis hyperchloraemic 78.86 13.98 27 51725 815 79691821
Weight increased 78.55 13.98 41 51711 277345 79415291
Blood creatine phosphokinase increased 78.30 13.98 148 51604 65942 79626694
Stress cardiomyopathy 76.23 13.98 61 51691 11105 79681531
Electrocardiogram QRS complex prolonged 71.45 13.98 58 51694 10775 79681861
Hypoventilation 70.70 13.98 49 51703 7175 79685461
Asthenia 70.65 13.98 141 51611 511548 79181088
Amylase increased 69.71 13.98 58 51694 11151 79681485
Back pain 66.13 13.98 60 51692 304120 79388516
Systemic lupus erythematosus 65.88 13.98 3 51749 121146 79571490
Hyperthermia 63.38 13.98 68 51684 17969 79674667
Epilepsy 63.34 13.98 103 51649 40757 79651879
Sinusitis 63.01 13.98 24 51728 195477 79497159
Neuromuscular block prolonged 62.61 13.98 24 51728 1006 79691630
Sedation complication 62.10 13.98 63 51689 15606 79677030
Myalgia 61.16 13.98 22 51730 185619 79507017
Septic shock 61.11 13.98 197 51555 122604 79570032
Bronchospasm 61.09 13.98 78 51674 24781 79667855
Renal ischaemia 59.81 13.98 24 51728 1138 79691498
Hypercapnia 59.27 13.98 48 51704 8887 79683749
Autonomic nervous system imbalance 58.91 13.98 37 51715 4593 79688043
Cardiogenic shock 58.75 13.98 101 51651 41813 79650823
Laryngospasm 58.68 13.98 35 51717 3962 79688674
Malaise 58.59 13.98 146 51606 489723 79202913
PCO2 increased 58.40 13.98 27 51725 1813 79690823
CSF oligoclonal band present 57.66 13.98 18 51734 403 79692233
Product administered to patient of inappropriate age 57.50 13.98 39 51713 5514 79687122
Pruritus 56.82 13.98 106 51646 394542 79298094
Oxygen saturation abnormal 56.76 13.98 36 51716 4546 79688090
Anticholinergic syndrome 56.63 13.98 33 51719 3578 79689058
Overdose 56.39 13.98 253 51499 183953 79508683
Muscle rigidity 56.30 13.98 67 51685 19815 79672821
Coagulopathy 56.13 13.98 91 51661 35915 79656721
Encephalitis autoimmune 55.66 13.98 28 51724 2266 79690370
Pneumatosis 55.07 13.98 21 51731 868 79691768
Upper airway obstruction 55.03 13.98 24 51728 1404 79691232
Seizure like phenomena 54.94 13.98 26 51726 1841 79690795
Wound 54.26 13.98 6 51746 116173 79576463
Hyperammonaemia 54.12 13.98 50 51702 11043 79681593
Respiratory arrest 54.01 13.98 117 51635 57433 79635203
Arthritis 53.48 13.98 6 51746 114874 79577762
Altered state of consciousness 52.98 13.98 99 51653 43723 79648913
Mydriasis 52.52 13.98 61 51691 17582 79675054
Hepatic ischaemia 50.46 13.98 21 51731 1094 79691542
Female genital tract fistula 50.35 13.98 37 51715 5938 79686698
Clonus 50.20 13.98 39 51713 6801 79685835
Hypoaesthesia 50.02 13.98 27 51725 179325 79513311
Abdominal pain upper 50.01 13.98 43 51709 223776 79468860
Asthma 49.91 13.98 13 51739 135082 79557554
Dyspnoea 49.81 13.98 339 51413 856686 78835950
Blood gases abnormal 49.31 13.98 21 51731 1159 79691477
Discomfort 48.54 13.98 11 51741 125606 79567030
Hyperammonaemic encephalopathy 48.12 13.98 33 51719 4749 79687887
Anaesthetic complication pulmonary 47.70 13.98 11 51741 71 79692565
Leukocytosis 47.41 13.98 94 51658 43361 79649275
Rash maculo-papular 47.01 13.98 109 51643 55969 79636667
Foetal death 46.69 13.98 40 51712 8004 79684632
Hypernatraemia 46.46 13.98 52 51700 14399 79678237
PO2 increased 46.38 13.98 22 51730 1566 79691070
Behaviour disorder 46.35 13.98 36 51716 6277 79686359
Carcinoid crisis 45.99 13.98 16 51736 507 79692129
Acute hepatic failure 45.44 13.98 75 51677 30038 79662598
Brain death 45.25 13.98 34 51718 5643 79686993
Ventricular tachycardia 44.90 13.98 90 51662 41845 79650791
Tachypnoea 44.59 13.98 77 51675 31986 79660650
Product use in unapproved indication 44.20 13.98 296 51456 250063 79442573
Ventricular extrasystoles 44.02 13.98 59 51693 19645 79672991
Bronchitis 43.85 13.98 15 51737 130629 79562007
Muscle relaxant therapy 43.84 13.98 12 51740 166 79692470
Catatonia 43.75 13.98 40 51712 8716 79683920
Hypertransaminasaemia 43.75 13.98 46 51706 11878 79680758
Gene mutation 43.33 13.98 25 51727 2661 79689975
Epileptic aura 42.91 13.98 10 51742 68 79692568
Neurotoxicity 42.51 13.98 76 51676 32442 79660194
Perforation 42.39 13.98 20 51732 1406 79691230
Disseminated intravascular coagulation 42.11 13.98 80 51672 35762 79656874
Contraindicated product administered 42.09 13.98 25 51727 157513 79535123
Dehydration 41.92 13.98 60 51692 248127 79444509
Ventricular hypokinesia 41.77 13.98 40 51712 9239 79683397
Vaginal flatulence 41.63 13.98 24 51728 2551 79690085
Weight decreased 41.54 13.98 107 51645 355091 79337545
Cholestasis 41.20 13.98 99 51653 52010 79640626
Procedural complication 40.93 13.98 37 51715 7946 79684690
Psoriasis 40.90 13.98 5 51747 89582 79603054
Acidosis 40.87 13.98 57 51695 19705 79672931
Electrocardiogram QT prolonged 40.51 13.98 140 51612 90246 79602390
Paradoxical drug reaction 40.22 13.98 35 51717 7150 79685486
Non-consummation 40.18 13.98 9 51743 50 79692586
Anorectal ulcer 40.18 13.98 9 51743 50 79692586
Infusion related reaction 39.54 13.98 55 51697 230182 79462454
Long QT syndrome 39.52 13.98 32 51720 5923 79686713
Musculoskeletal pain 39.47 13.98 9 51743 102345 79590291
Proctitis 39.41 13.98 33 51719 6399 79686237
Pleocytosis 39.18 13.98 19 51733 1420 79691216
Tonic clonic movements 39.01 13.98 22 51730 2242 79690394
Hepatic failure 38.79 13.98 107 51645 61105 79631531
Mixed liver injury 38.61 13.98 35 51717 7543 79685093
Dyskinesia 38.60 13.98 88 51664 44685 79647951
Anticonvulsant drug level below therapeutic 37.90 13.98 17 51735 1064 79691572
Posterior reversible encephalopathy syndrome 37.71 13.98 64 51688 26217 79666419
White blood cell count decreased 37.59 13.98 40 51712 188248 79504388
Musculoskeletal stiffness 37.44 13.98 35 51717 174973 79517663
Blood cholesterol increased 37.43 13.98 5 51747 83715 79608921
Aggression 37.30 13.98 94 51658 50864 79641772
Blood pH decreased 37.07 13.98 28 51724 4683 79687953
Neuromuscular blockade 37.00 13.98 14 51738 566 79692070
Sinus bradycardia 36.91 13.98 62 51690 25185 79667451
Oropharyngeal oedema 36.75 13.98 13 51739 433 79692203
Blood potassium increased 36.46 13.98 67 51685 29208 79663428
Decreased appetite 36.42 13.98 108 51644 342310 79350326
Pseudopolyp 36.39 13.98 13 51739 446 79692190
Diabetic macroangiopathy 36.29 13.98 10 51742 142 79692494
Loss of personal independence in daily activities 35.80 13.98 11 51741 102569 79590067
Ultrasound ovary abnormal 35.73 13.98 9 51743 88 79692548
Unmasking of previously unidentified disease 35.48 13.98 20 51732 2037 79690599
Dry mouth 35.45 13.98 7 51745 88012 79604624
Cardio-respiratory arrest 35.43 13.98 152 51600 108358 79584278
Kounis syndrome 34.92 13.98 26 51726 4256 79688380
Trigemino-cardiac reflex 34.75 13.98 11 51741 258 79692378
COVID-19 pneumonia 34.65 13.98 65 51687 28784 79663852
Artery dissection 34.40 13.98 11 51741 267 79692369
Fluid retention 34.18 13.98 3 51749 69806 79622830
Electrocardiogram ST segment depression 34.05 13.98 27 51725 4851 79687785
Arrhythmia 33.89 13.98 102 51650 61170 79631466
Airway complication of anaesthesia 33.69 13.98 12 51740 408 79692228
Hypotonia 32.60 13.98 41 51711 12829 79679807
Blood bicarbonate decreased 32.57 13.98 27 51725 5164 79687472
Palpitations 32.55 13.98 21 51731 126589 79566047
Herpes zoster 32.45 13.98 10 51742 93073 79599563
Paraesthesia 32.44 13.98 40 51712 176283 79516353
Diabetes mellitus 32.07 13.98 6 51746 78384 79614252
Airway peak pressure increased 32.03 13.98 11 51741 335 79692301
Neuroleptic malignant syndrome 31.74 13.98 61 51691 27498 79665138
Mucosal ulceration 31.73 13.98 18 51734 1855 79690781
Intestinal infarction 31.51 13.98 16 51736 1320 79691316
Post procedural hypotension 31.51 13.98 8 51744 81 79692555
Gait disturbance 31.38 13.98 54 51698 207452 79485184
Corneal reflex decreased 31.34 13.98 11 51741 358 79692278
Impaired healing 31.31 13.98 9 51743 87646 79604990
Ventricular fibrillation 31.21 13.98 66 51686 31860 79660776
Change in seizure presentation 31.15 13.98 12 51740 510 79692126
Cardiac failure congestive 31.02 13.98 28 51724 142374 79550262
Cardiotoxicity 31.01 13.98 39 51713 12200 79680436
Hepatocellular injury 30.96 13.98 84 51668 47509 79645127
Radiculopathy 30.53 13.98 33 51719 8791 79683845
Procedural hypotension 30.44 13.98 18 51734 2005 79690631
Respiratory distress 30.29 13.98 95 51657 58244 79634392
Blood pressure increased 30.18 13.98 57 51695 211303 79481333
Therapeutic product effect prolonged 29.94 13.98 12 51740 567 79692069
Acute kidney injury 29.86 13.98 488 51264 518916 79173720
Alanine aminotransferase increased 29.75 13.98 194 51558 162376 79530260
Eosinophilia 29.46 13.98 80 51672 45265 79647371
Epilepsy with myoclonic-atonic seizures 29.40 13.98 8 51744 108 79692528
Vulvovaginal candidiasis 29.28 13.98 19 51733 2495 79690141
Arthrofibrosis 29.27 13.98 8 51744 110 79692526
Intensive care unit delirium 29.27 13.98 7 51745 54 79692582
Blood pressure decreased 29.21 13.98 135 51617 99331 79593305
Intensive care 28.66 13.98 14 51738 1063 79691573
Transaminases increased 28.48 13.98 86 51666 51657 79640979
Feeling abnormal 28.36 13.98 37 51715 159162 79533474
Contusion 28.16 13.98 33 51719 148743 79543893
Hospitalisation 28.05 13.98 13 51739 94223 79598413
Myocardial infarction 27.77 13.98 48 51704 184081 79508555
Migraine 27.75 13.98 11 51741 87482 79605154
Injection site pain 27.72 13.98 26 51726 129812 79562824
Left ventricular dysfunction 27.58 13.98 47 51705 19314 79673322
Acid base balance abnormal 27.48 13.98 10 51742 362 79692274
Macroglossia 27.44 13.98 14 51738 1167 79691469
Acute respiratory failure 27.35 13.98 93 51659 59448 79633188
Stomatitis 27.30 13.98 33 51719 146724 79545912
Irritable bowel syndrome 27.16 13.98 4 51748 62237 79630399
Cough 27.15 13.98 134 51618 366655 79325981
Pulse absent 26.89 13.98 33 51719 10070 79682566
Intracranial pressure increased 26.85 13.98 30 51722 8292 79684344
Hepatitis fulminant 26.61 13.98 28 51724 7234 79685402
Nail dystrophy 26.46 13.98 13 51739 1000 79691636
Hyperaesthesia 26.40 13.98 36 51716 12186 79680450
Procedural vomiting 26.34 13.98 12 51740 779 79691857
Stupor 26.09 13.98 27 51725 6845 79685791
Somnolence 26.00 13.98 253 51499 238728 79453908
Inappropriate schedule of product administration 25.99 13.98 29 51723 133599 79559037
Local anaesthetic systemic toxicity 25.97 13.98 13 51739 1041 79691595
Gastrooesophageal reflux disease 25.84 13.98 18 51734 104228 79588408
Bone pain 25.72 13.98 3 51749 55739 79636897
Laryngeal stenosis 25.58 13.98 13 51739 1075 79691561
Vomiting 25.46 13.98 293 51459 665535 79027101
Mobility decreased 25.46 13.98 25 51727 122150 79570486
Urinary tract infection 25.43 13.98 92 51660 274420 79418216
Sleep disorder 25.22 13.98 12 51740 85665 79606971
Hot flush 25.20 13.98 3 51749 54874 79637762
Injection site reaction 25.15 13.98 3 51749 54782 79637854
Oliguria 25.12 13.98 41 51711 16268 79676368
Reversal of sedation 24.78 13.98 5 51747 15 79692621
Pulmonary oedema 24.60 13.98 118 51634 88136 79604500
Influenza like illness 24.46 13.98 8 51744 71699 79620937
Therapeutic product effect decreased 24.45 13.98 43 51709 163820 79528816
Atrioventricular dissociation 24.44 13.98 9 51743 337 79692299
Haemoglobin decreased 24.37 13.98 69 51683 222050 79470586
Blood lactate dehydrogenase increased 24.35 13.98 68 51684 39102 79653534
Paralysis 24.31 13.98 36 51716 13141 79679495
Gastrointestinal scarring 24.10 13.98 9 51743 351 79692285
Lower respiratory tract infection 24.10 13.98 29 51723 129191 79563445
Hepatic enzyme increased 23.72 13.98 52 51700 182558 79510078
Stridor 23.59 13.98 23 51729 5430 79687206
Muscle spasms 23.32 13.98 49 51703 174681 79517955
Areflexia 23.31 13.98 23 51729 5511 79687125
Malabsorption 23.24 13.98 22 51730 5010 79687626
Influenza 23.21 13.98 30 51722 129576 79563060
Rash 23.09 13.98 252 51500 578106 79114530
Ischaemic hepatitis 22.87 13.98 19 51733 3645 79688991
Pneumomediastinum 22.85 13.98 19 51733 3648 79688988
Endotracheal intubation complication 22.82 13.98 11 51741 811 79691825
Chest pain 22.73 13.98 100 51652 282204 79410432
Nystagmus 22.65 13.98 30 51722 9874 79682762
Large intestinal stenosis 22.53 13.98 17 51735 2839 79689797
Oedema peripheral 22.42 13.98 86 51666 252202 79440434
Hepatorenal syndrome 22.39 13.98 20 51732 4229 79688407
Manipulation 22.26 13.98 6 51746 78 79692558
Chronic obstructive pulmonary disease 22.19 13.98 14 51738 85405 79607231
Mixed dementia 22.16 13.98 8 51744 283 79692353
Herpes simplex viraemia 22.13 13.98 9 51743 442 79692194
Nasal congestion 22.11 13.98 11 51741 76541 79616095
Oral candidiasis 22.04 13.98 55 51697 29573 79663063
Cytokine release syndrome 21.89 13.98 62 51690 35936 79656700
Malignant catatonia 21.86 13.98 9 51743 456 79692180
Post procedural complication 21.84 13.98 48 51704 23781 79668855
Superinfection 21.82 13.98 21 51731 4881 79687755
Adverse drug reaction 21.63 13.98 8 51744 66384 79626252
Euthyroid sick syndrome 21.47 13.98 6 51746 90 79692546
Muscle injury 21.47 13.98 3 51749 48558 79644078
Stevens-Johnson syndrome 21.46 13.98 65 51687 39101 79653535
Gastrointestinal disorder 21.16 13.98 29 51723 122176 79570460
Cyanosis 21.16 13.98 49 51703 25133 79667503
Product contamination 21.05 13.98 12 51740 1248 79691388
Large intestine anastomosis 20.99 13.98 6 51746 98 79692538
Vasoplegia syndrome 20.96 13.98 18 51734 3612 79689024
Hypertrophic cardiomyopathy 20.87 13.98 15 51737 2325 79690311
Medical device site fistula 20.86 13.98 5 51747 39 79692597
Cellulitis 20.84 13.98 24 51728 109036 79583600
Pituitary apoplexy 20.61 13.98 7 51745 206 79692430
Pneumothorax 20.47 13.98 52 51700 28271 79664365
Skin ulcer 20.40 13.98 5 51747 54145 79638491
Renal impairment 20.17 13.98 173 51579 157610 79535026
Nervous system disorder 20.13 13.98 50 51702 26806 79665830
Symptom masked 19.96 13.98 12 51740 1378 79691258
Restlessness 19.95 13.98 71 51681 46421 79646215
Vertigo 19.84 13.98 10 51742 69072 79623564
Infection 19.83 13.98 85 51667 241627 79451009
Fear 19.83 13.98 44 51708 21942 79670694
Nephrogenic diabetes insipidus 19.77 13.98 14 51738 2120 79690516
Axillary pain 19.69 13.98 14 51738 2135 79690501
Hyperdynamic left ventricle 19.63 13.98 8 51744 395 79692241
Transient ischaemic attack 19.59 13.98 5 51747 52690 79639946
Drug resistance 19.44 13.98 66 51686 42147 79650489
Cataract 19.39 13.98 8 51744 62112 79630524
Drug withdrawal convulsions 19.28 13.98 14 51738 2206 79690430
Hypersensitivity 19.28 13.98 96 51656 262143 79430493
Vaginal discharge 19.26 13.98 24 51728 7439 79685197
C-reactive protein abnormal 19.16 13.98 4 51748 48363 79644273
Neutropenia 19.11 13.98 109 51643 287601 79405035
Post procedural haemorrhage 19.10 13.98 33 51719 13711 79678925
Visual impairment 19.03 13.98 19 51733 92112 79600524
Brain stem auditory evoked response abnormal 19.02 13.98 3 51749 0 79692636
Electrocardiogram repolarisation abnormality 19.01 13.98 14 51738 2253 79690383
Haemophagocytic lymphohistiocytosis 18.91 13.98 43 51709 21794 79670842
Ileus 18.81 13.98 48 51704 26163 79666473
Myotonic dystrophy 18.79 13.98 6 51746 145 79692491
Injection site erythema 18.73 13.98 14 51738 78183 79614453
Apnoeic attack 18.66 13.98 9 51743 665 79691971
Wrong product administered 18.64 13.98 26 51726 8986 79683650
Balance disorder 18.63 13.98 22 51730 98835 79593801
Injection site swelling 18.46 13.98 4 51748 47128 79645508
Drug withdrawal syndrome 18.45 13.98 57 51695 34661 79657975
Abdominal compartment syndrome 18.43 13.98 12 51740 1585 79691051
Adverse event 18.40 13.98 8 51744 60206 79632430
Procedural pain 18.40 13.98 44 51708 23040 79669596
Dystonia 18.38 13.98 42 51710 21357 79671279
Rash pruritic 18.25 13.98 12 51740 71617 79621019
Polyuria 18.24 13.98 34 51718 14980 79677656
Dermatitis exfoliative generalised 18.23 13.98 23 51729 7218 79685418
Liver function test 18.23 13.98 6 51746 160 79692476
Anticonvulsant drug level therapeutic 18.21 13.98 4 51748 20 79692616
Thrombocytopenia 18.20 13.98 257 51495 265002 79427634
Gastrointestinal mucosa hyperaemia 18.20 13.98 8 51744 477 79692159
Oedema 18.18 13.98 31 51721 119549 79573087
Sinus tachycardia 18.15 13.98 59 51693 36849 79655787
Lactic acidosis 18.13 13.98 92 51660 70267 79622369
Infection parasitic 18.00 13.98 8 51744 490 79692146
Psychomotor hyperactivity 17.84 13.98 36 51716 16813 79675823
Coronary artery embolism 17.79 13.98 7 51745 315 79692321
Defect conduction intraventricular 17.77 13.98 8 51744 505 79692131
Ventricular arrhythmia 17.54 13.98 25 51727 8815 79683821
Vision blurred 17.47 13.98 26 51726 105872 79586764
Renal failure 17.29 13.98 203 51549 200765 79491871
Haematuria traumatic 17.22 13.98 6 51746 191 79692445
Blood magnesium decreased 17.15 13.98 35 51717 16477 79676159
Drug level below therapeutic 17.03 13.98 26 51726 9744 79682892
Dyspnoea paroxysmal nocturnal 17.00 13.98 13 51739 2215 79690421
Postoperative delirium 16.98 13.98 7 51745 356 79692280
Dissociative disorder 16.98 13.98 9 51743 812 79691824
Premature delivery 16.87 13.98 43 51709 23424 79669212
Dysgeusia 16.84 13.98 8 51744 57169 79635467
Ill-defined disorder 16.83 13.98 11 51741 65864 79626772
Full blood count abnormal 16.76 13.98 3 51749 40471 79652165
Neurological examination abnormal 16.61 13.98 8 51744 589 79692047
Bradypnoea 16.48 13.98 20 51732 6032 79686604
Systolic dysfunction 16.41 13.98 16 51736 3779 79688857
Completed suicide 16.37 13.98 93 51659 245674 79446962
Blister 16.37 13.98 33 51719 119443 79573193
Seizure cluster 16.29 13.98 7 51745 395 79692241
Osteonecrosis of jaw 16.27 13.98 4 51748 43222 79649414
Neck pain 16.22 13.98 15 51737 75402 79617234
Brain herniation 16.14 13.98 22 51730 7441 79685195
Post procedural stroke 16.14 13.98 5 51747 109 79692527
Accelerated idioventricular rhythm 16.14 13.98 6 51746 231 79692405
Cystitis 16.12 13.98 7 51745 52725 79639911
Hyperexplexia 15.98 13.98 4 51748 38 79692598
Hypokalaemia 15.90 13.98 153 51599 143887 79548749
End-tidal CO2 decreased 15.89 13.98 4 51748 39 79692597
Osteoarthritis 15.85 13.98 20 51732 87289 79605347
Clonic convulsion 15.84 13.98 10 51742 1252 79691384
Drug chemical incompatibility 15.81 13.98 5 51747 117 79692519
Hepatic cytolysis 15.77 13.98 46 51706 27105 79665531
Pseudomonas infection 15.76 13.98 39 51713 20864 79671772
Dermatitis bullous 15.76 13.98 31 51721 14214 79678422
Catheter site haemorrhage 15.75 13.98 18 51734 5099 79687537
Injection site pruritus 15.74 13.98 4 51748 42279 79650357
Cardiovascular insufficiency 15.64 13.98 14 51738 2967 79689669
Angina pectoris 15.61 13.98 7 51745 51725 79640911
Neutrophil count decreased 15.57 13.98 23 51729 93936 79598700
Delayed graft function 15.56 13.98 15 51737 3492 79689144
Gastric ulcer perforation 15.29 13.98 12 51740 2123 79690513
No adverse event 15.28 13.98 56 51696 37136 79655500
Frequent bowel movements 15.24 13.98 48 51704 29491 79663145
Abdominal rigidity 15.22 13.98 14 51738 3074 79689562
Eye pain 15.11 13.98 3 51749 37575 79655061
Catecholamine crisis 14.99 13.98 4 51748 50 79692586
Myoglobin blood increased 14.98 13.98 14 51738 3137 79689499
C-reactive protein increased 14.96 13.98 39 51713 128988 79563648
Blood pressure fluctuation 14.86 13.98 13 51739 67132 79625504
Colitis ulcerative 14.86 13.98 53 51699 34689 79657947
Febrile infection-related epilepsy syndrome 14.84 13.98 4 51748 52 79692584
Syncope 14.78 13.98 63 51689 179386 79513250
Laryngeal oedema 14.69 13.98 22 51730 8107 79684529
Hyperbilirubinaemia 14.68 13.98 42 51710 24476 79668160
Cardiac output decreased 14.63 13.98 11 51741 1827 79690809
Acute pulmonary oedema 14.59 13.98 30 51722 14200 79678436
Anaphylactoid shock 14.58 13.98 8 51744 773 79691863
Long QT syndrome congenital 14.57 13.98 5 51747 152 79692484
Thrombosis 14.51 13.98 20 51732 84080 79608556
Intentional overdose 14.51 13.98 118 51634 105842 79586794
Illness 14.50 13.98 6 51746 46505 79646131
Hypertriglyceridaemia 14.43 13.98 28 51724 12712 79679924
Peroneal nerve injury 14.31 13.98 4 51748 60 79692576
Psychotic disorder 14.29 13.98 59 51693 41343 79651293
Nephrocalcinosis 14.26 13.98 10 51742 1492 79691144
Central nervous system stimulation 14.25 13.98 4 51748 61 79692575
Teratoma 14.24 13.98 5 51747 163 79692473
Paradoxical pain 14.20 13.98 3 51749 12 79692624
Buttock injury 14.04 13.98 5 51747 170 79692466
Heart alternation 14.01 13.98 3 51749 13 79692623

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 61.12 27.94 31 127 1021 88613
Epilepsy 34.62 27.94 11 147 93 89541

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 D018686 Anesthetics, Intravenous
MeSH PA D014151 Anti-Anxiety Agents
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 D006993 Hypnotics and Sedatives
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D014149 Tranquilizing Agents
CHEBI has role CHEBI:35474 anti-anxiety agents
CHEBI has role CHEBI:35488 central nervous system depressants
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:35623 anticonvulsants
CHEBI has role CHEBI:35717 hypnotics
CHEBI has role CHEBI:38869 general anaesthetic
CHEBI has role CHEBI:51371 muscle relaxants
CHEBI has role CHEBI:68495 Type I cell-death inducers
CHEBI has role CHEBI:91016 GABAA receptor agonists
FDA EPC N0000175694 Benzodiazepine

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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
100MG/100ML (1MG/ML) MIDAZOLAM IN 0.9% SODIUM CHLORIDE HIKMA A216159 April 17, 2023 RX SOLUTION INTRAVENOUS Jan. 2, 2024 PATENT CHALLENGE
50MG/50ML (1MG/ML) MIDAZOLAM IN 0.9% SODIUM CHLORIDE HIKMA A216159 April 17, 2023 RX SOLUTION INTRAVENOUS Jan. 2, 2024 PATENT CHALLENGE
EQ 50MG BASE/10ML (EQ 5MG BASE/ML) SEIZALAM MMT N209566 Sept. 14, 2018 RX SOLUTION INTRAMUSCULAR Sept. 14, 2025 TREATMENT OF STATUS EPILEPTICUS IN ADULTS
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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-3566 SYRUP 2 mg ORAL ANDA 25 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-3566 SYRUP 2 mg ORAL ANDA 25 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-3566 SYRUP 2 mg ORAL ANDA 25 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 HUMAN PRESCRIPTION DRUG LABEL 1 0404-9912 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 14 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0404-9912 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 14 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 0404-9913 INJECTION 1 mg INTRAMUSCULAR ANDA 15 sections
MIDAZOLAM HUMAN PRESCRIPTION DRUG LABEL 1 0404-9914 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 15 sections
MIDAZOLAM HUMAN PRESCRIPTION DRUG LABEL 1 0404-9914 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 15 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0404-9915 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 14 sections
Midazolam HUMAN PRESCRIPTION DRUG LABEL 1 0404-9915 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 14 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0404-9916 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 15 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0404-9916 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 15 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2305 INJECTION, SOLUTION 1 mg INTRAMUSCULAR ANDA 29 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2305 INJECTION, SOLUTION 1 mg INTRAMUSCULAR ANDA 29 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2305 INJECTION, SOLUTION 1 mg INTRAMUSCULAR ANDA 29 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2305 INJECTION, SOLUTION 1 mg INTRAMUSCULAR ANDA 29 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2305 INJECTION, SOLUTION 1 mg INTRAMUSCULAR ANDA 29 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2305 INJECTION, SOLUTION 1 mg INTRAMUSCULAR ANDA 29 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2308 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 29 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2308 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 29 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2308 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 29 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2308 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 29 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2308 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 29 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2308 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 29 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2587 INJECTION, SOLUTION 1 mg INTRAMUSCULAR ANDA 28 sections
Midazolam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2587 INJECTION, SOLUTION 1 mg INTRAMUSCULAR ANDA 28 sections