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

Stem definitionDrug idCAS RN
diazepam derivatives 2585 846-50-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • temazepam
  • (RS)-Temazepam
  • levanxene
  • levanxol
A benzodiazepine that acts as a GAMMA-AMINOBUTYRIC ACID modulator and anti-anxiety agent.
  • Molecular weight: 300.74
  • Formula: C16H13ClN2O2
  • CLOGP: 2.34
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 52.90
  • ALOGS: -3.75
  • ROTB: 1

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
20 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.60 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.83 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 91 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Feb. 27, 1981 FDA MALLINCKRODT INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 451.90 10.06 583 52705 145090 63290644
Toxicity to various agents 399.57 10.06 731 52557 246519 63189215
Temperature regulation disorder 324.47 10.06 139 53149 5993 63429741
Coeliac disease 248.52 10.06 147 53141 12650 63423084
Food allergy 248.05 10.06 141 53147 11260 63424474
Overdose 232.36 10.06 376 52912 114702 63321032
Immunodeficiency 178.69 10.06 143 53145 20111 63415623
Hyperhidrosis 156.47 10.06 305 52983 107531 63328203
Pemphigus 139.60 10.06 3 53285 183723 63252011
Rash erythematous 126.59 10.06 167 53121 42343 63393391
Bursitis 125.25 10.06 155 53133 36886 63398848
Synovitis 122.37 10.06 9 53279 186909 63248825
Fluid retention 116.25 10.06 192 53096 59494 63376240
Hand deformity 109.36 10.06 6 53282 159451 63276283
Respiratory arrest 107.80 10.06 135 53153 32510 63403224
Maternal exposure during pregnancy 106.02 10.06 27 53261 220035 63215699
Drug ineffective 99.08 10.06 497 52791 1044268 62391466
Arthropathy 95.12 10.06 39 53249 234753 63200981
Glossodynia 89.98 10.06 20 53268 178856 63256878
Anti-cyclic citrullinated peptide antibody positive 84.18 10.06 3 53285 116209 63319525
Wound 82.63 10.06 18 53270 163245 63272489
Systemic lupus erythematosus 82.54 10.06 36 53252 208882 63226852
Myocardial depression 81.51 10.06 26 53262 478 63435256
Constipation 79.93 10.06 387 52901 224556 63211178
Swelling 75.40 10.06 72 53216 275306 63160428
Off label use 75.00 10.06 302 52986 674160 62761574
Pericarditis 74.16 10.06 11 53277 131568 63304166
Drug intolerance 72.08 10.06 92 53196 308569 63127165
Decorticate posture 71.67 10.06 21 53267 286 63435448
Back pain 70.42 10.06 420 52868 263725 63172009
Abdominal discomfort 69.53 10.06 101 53187 320784 63114950
Cardiac arrest 67.92 10.06 201 53087 92344 63343390
Discomfort 67.44 10.06 28 53260 167346 63268388
Upper respiratory tract infection 66.81 10.06 185 53103 81862 63353872
Poisoning 64.38 10.06 68 53220 13632 63422102
Asthma 62.59 10.06 242 53046 127319 63308415
Accidental overdose 58.00 10.06 84 53204 23225 63412509
Libido increased 56.69 10.06 26 53262 1319 63434415
Rectal polyp 55.54 10.06 25 53263 1214 63434520
Rheumatoid factor positive 55.39 10.06 4 53284 84402 63351332
Respiratory depression 53.93 10.06 62 53226 13653 63422081
Cardio-respiratory arrest 53.64 10.06 140 53148 59819 63375915
Drug abuse 52.72 10.06 157 53131 72361 63363373
Victim of sexual abuse 51.59 10.06 20 53268 664 63435070
Hostility 51.37 10.06 27 53261 1845 63433889
Substance abuse 49.04 10.06 37 53251 4770 63430964
Alopecia 48.44 10.06 135 53153 337401 63098333
Therapeutic product effect decreased 47.79 10.06 55 53233 193132 63242602
Arthralgia 45.52 10.06 286 53002 569424 62866310
Duodenal ulcer perforation 45.37 10.06 9 53279 87200 63348534
Judgement impaired 44.47 10.06 19 53269 813 63434921
Folliculitis 44.28 10.06 4 53284 70313 63365421
Rash 42.55 10.06 286 53002 560585 62875149
Infusion related reaction 42.48 10.06 89 53199 245432 63190302
Change of bowel habit 42.07 10.06 25 53263 2168 63433566
Sternal fracture 41.43 10.06 25 53263 2229 63433505
Post-traumatic neck syndrome 40.72 10.06 24 53264 2050 63433684
Venous pressure jugular increased 40.45 10.06 16 53272 561 63435173
Coma scale abnormal 40.44 10.06 34 53254 5119 63430615
Soft tissue injury 40.20 10.06 22 53266 1630 63434104
Duodenal ulcer 39.14 10.06 40 53248 7716 63428018
Therapeutic product effect incomplete 37.44 10.06 30 53258 125026 63310708
Anxiety 37.37 10.06 311 52977 217230 63218504
Amblyopia 35.82 10.06 12 53276 259 63435475
Hypothermia 35.34 10.06 50 53238 13531 63422203
Intentional overdose 34.98 10.06 139 53149 74013 63361721
Insomnia 34.48 10.06 303 52985 214949 63220785
Impaired reasoning 34.20 10.06 9 53279 80 63435654
Peripheral swelling 34.09 10.06 112 53176 265830 63169904
Transplant dysfunction 33.88 10.06 30 53258 4842 63430892
Intestinal haemorrhage 33.57 10.06 27 53261 3820 63431914
Drug withdrawal syndrome 33.56 10.06 72 53216 27122 63408612
Intentional product use issue 33.17 10.06 35 53253 127857 63307877
Infected dermal cyst 32.91 10.06 13 53275 454 63435280
Mass 32.73 10.06 49 53239 13951 63421783
Psoriatic arthropathy 32.73 10.06 18 53270 91502 63344232
Sensitisation 32.21 10.06 25 53263 3361 63432373
Nasopharyngitis 31.96 10.06 108 53180 254149 63181585
Suicidal ideation 31.88 10.06 120 53168 62301 63373433
Musculoskeletal stiffness 31.02 10.06 68 53220 184550 63251184
Tremor 30.63 10.06 203 53085 132036 63303698
Toxicologic test abnormal 30.59 10.06 14 53274 707 63435027
Urine odour abnormal 30.53 10.06 32 53256 6357 63429377
Infection 30.42 10.06 95 53193 229078 63206656
Liver injury 29.94 10.06 7 53281 60513 63375221
Blister 29.93 10.06 39 53249 129775 63305959
Proctalgia 29.91 10.06 31 53257 6079 63429655
Frustration tolerance decreased 29.88 10.06 33 53255 6955 63428779
Intentional product misuse 29.38 10.06 115 53173 60802 63374932
Somnolence 29.37 10.06 253 53035 178432 63257302
General physical health deterioration 29.27 10.06 80 53208 201322 63234412
Thiopurine methyltransferase decreased 29.24 10.06 11 53277 336 63435398
Kyphosis 29.17 10.06 21 53267 2519 63433215
Accidental death 28.99 10.06 19 53269 1957 63433777
Injection site discomfort 27.31 10.06 26 53262 4604 63431130
Somnambulism 26.91 10.06 28 53260 5515 63430219
Gastrointestinal disorder 26.75 10.06 43 53245 131196 63304538
Dehydration 26.71 10.06 242 53046 173112 63262622
Rectal prolapse 26.52 10.06 18 53270 1965 63433769
Unresponsive to stimuli 26.28 10.06 75 53213 33741 63401993
Nightmare 26.24 10.06 53 53235 19141 63416593
Apnoea 26.19 10.06 33 53255 7989 63427745
Stomatitis 25.95 10.06 48 53240 138677 63297057
Withdrawal syndrome 25.90 10.06 54 53234 19943 63415791
Personality disorder 25.82 10.06 28 53260 5783 63429951
Mental disorder 25.76 10.06 63 53225 25856 63409878
Rheumatic fever 25.72 10.06 3 53285 43108 63392626
Postmortem blood drug level 25.72 10.06 8 53280 135 63435599
Exposure during pregnancy 25.55 10.06 58 53230 155489 63280245
Treatment failure 25.37 10.06 84 53204 198959 63236775
Ill-defined disorder 25.24 10.06 19 53269 81736 63353998
Miosis 25.21 10.06 31 53257 7322 63428412
Band neutrophil percentage increased 25.11 10.06 9 53279 239 63435495
Poor quality sleep 24.85 10.06 53 53235 19882 63415852
Furuncle 24.67 10.06 29 53259 6537 63429197
Muscle injury 24.63 10.06 12 53276 65333 63370401
Neutropenia 24.33 10.06 71 53217 174934 63260800
Foetal death 23.65 10.06 37 53251 10943 63424791
Arteriosclerosis coronary artery 23.54 10.06 32 53256 8341 63427393
Antidepressant drug level above therapeutic 23.42 10.06 10 53278 427 63435307
Irritable bowel syndrome 23.16 10.06 21 53267 82391 63353343
Myelocyte percentage increased 22.55 10.06 8 53280 206 63435528
Depression 22.46 10.06 258 53030 196234 63239500
Peripheral coldness 22.16 10.06 38 53250 12127 63423607
Knee arthroplasty 21.93 10.06 9 53279 54197 63381537
Joint swelling 21.92 10.06 173 53115 327493 63108241
Panic attack 21.90 10.06 54 53234 22277 63413457
Ventricular hypokinesia 21.73 10.06 23 53265 4621 63431113
Polyp 21.57 10.06 27 53261 6494 63429240
Musculoskeletal discomfort 21.52 10.06 47 53241 17920 63417814
Irritability 21.51 10.06 67 53221 31627 63404107
C-reactive protein increased 21.27 10.06 29 53259 94678 63341056
Homicide 21.27 10.06 9 53279 376 63435358
Band neutrophil count increased 21.04 10.06 9 53279 386 63435348
Condition aggravated 21.02 10.06 226 53062 401991 63033743
Urine oxalate increased 20.97 10.06 8 53280 254 63435480
Hip arthroplasty 20.80 10.06 7 53281 47639 63388095
Oesophagitis ulcerative 20.53 10.06 10 53278 581 63435153
Diabetes mellitus 20.47 10.06 97 53191 55713 63380021
Bladder disorder 20.47 10.06 31 53257 8915 63426819
Helicobacter infection 20.25 10.06 29 53259 92756 63342978
Abnormal behaviour 20.16 10.06 51 53237 21375 63414359
Retinal depigmentation 20.10 10.06 8 53280 285 63435449
Urine abnormality 20.00 10.06 27 53261 6992 63428742
Analgesic drug level above therapeutic 19.89 10.06 7 53281 176 63435558
Bundle branch block left 19.88 10.06 27 53261 7032 63428702
Blood glucose decreased 19.84 10.06 50 53238 20902 63414832
Urticaria 19.76 10.06 72 53216 165730 63270004
Interstitial lung disease 19.61 10.06 14 53274 61894 63373840
Contraindicated product administered 19.59 10.06 105 53183 217543 63218191
Prescribed overdose 19.42 10.06 68 53220 34085 63401649
Stress 19.27 10.06 109 53179 67058 63368676
Death 19.23 10.06 430 52858 373951 63061783
Hypovolaemia 18.99 10.06 33 53255 10640 63425094
Drug dependence 18.73 10.06 54 53234 24429 63411305
Hyperthermia 18.55 10.06 30 53258 9126 63426608
Suspected product quality issue 18.48 10.06 7 53281 218 63435516
Myelocyte count increased 18.30 10.06 8 53280 362 63435372
Loss of consciousness 18.23 10.06 165 53123 117956 63317778
Mental impairment 18.08 10.06 38 53250 14113 63421621
Dystrophic calcification 17.97 10.06 6 53282 128 63435606
Cardiac failure congestive 17.95 10.06 136 53152 92297 63343437
Sinusitis 17.92 10.06 114 53174 226539 63209195
Mobility decreased 17.68 10.06 48 53240 121111 63314623
Potentiating drug interaction 17.65 10.06 20 53268 4336 63431398
Rib fracture 17.44 10.06 50 53238 22547 63413187
Ovarian cyst 17.19 10.06 40 53248 15905 63419829
Erythema 17.14 10.06 224 53064 175527 63260207
Pulmonary congestion 16.95 10.06 42 53246 17376 63418358
Homicidal ideation 16.80 10.06 13 53275 1739 63433995
Upper respiratory tract congestion 16.76 10.06 14 53274 2088 63433646
Mood swings 16.71 10.06 43 53245 18205 63417529
Atrioventricular block first degree 16.35 10.06 25 53263 7248 63428486
Thyroid disorder 16.30 10.06 38 53250 15124 63420610
Injection site erythema 16.25 10.06 28 53260 83146 63352588
Postoperative wound infection 15.94 10.06 31 53257 10894 63424840
Febrile neutropenia 15.77 10.06 49 53239 118400 63317334
Rebound psychosis 15.69 10.06 6 53282 192 63435542
Bruxism 15.69 10.06 17 53271 3508 63432226
Depressed mood 15.58 10.06 71 53217 40120 63395614
Urinary incontinence 15.08 10.06 60 53228 31954 63403780
Transplant rejection 15.01 10.06 30 53258 10750 63424984
COVID-19 14.91 10.06 47 53241 113056 63322678
Pruritus 14.77 10.06 214 53074 361239 63074495
Suspected counterfeit product 14.75 10.06 7 53281 384 63435350
Product use in unapproved indication 14.70 10.06 89 53199 178991 63256743
Calculus urethral 14.65 10.06 3 53285 7 63435727
Postmortem blood drug level increased 14.58 10.06 8 53280 596 63435138
Abortion spontaneous 14.53 10.06 11 53277 47184 63388550
Mania 14.41 10.06 32 53256 12335 63423399
Monocyte percentage increased 14.36 10.06 10 53278 1138 63434596
Limb discomfort 14.25 10.06 56 53232 29660 63406074
Dysgeusia 14.19 10.06 77 53211 46633 63389101
Poisoning deliberate 14.19 10.06 30 53258 11188 63424546
Bacterial test 14.16 10.06 10 53278 1164 63434570
Dysuria 14.14 10.06 61 53227 33677 63402057
Fall 14.13 10.06 430 52858 391904 63043830
Victim of crime 14.12 10.06 5 53283 128 63435606
Lung disorder 14.05 10.06 19 53269 62242 63373492
Premature delivery 14.02 10.06 4 53284 30277 63405457
Arteriosclerosis 14.00 10.06 28 53260 10038 63425696
Middle insomnia 13.94 10.06 32 53256 12611 63423123
Hepatocellular injury 13.88 10.06 3 53285 27378 63408356
Respiratory alkalosis 13.76 10.06 14 53274 2687 63433047
Haemorrhage 13.71 10.06 93 53195 60929 63374805
Cardioactive drug level above therapeutic 13.57 10.06 5 53283 144 63435590
Flight of ideas 13.47 10.06 7 53281 467 63435267
Needle issue 13.41 10.06 28 53260 10348 63425386
Akathisia 13.40 10.06 26 53262 9120 63426614
Dilatation atrial 13.33 10.06 12 53276 1979 63433755
Memory impairment 13.32 10.06 140 53148 104118 63331616
Impaired healing 13.25 10.06 43 53245 102499 63333235
Concussion 13.20 10.06 26 53262 9218 63426516
Chronic obstructive pulmonary disease 13.18 10.06 94 53194 62592 63373142
Gallbladder disorder 12.94 10.06 40 53248 18802 63416932
Specific gravity urine decreased 12.66 10.06 8 53280 774 63434960
Microscopic polyangiitis 12.36 10.06 5 53283 186 63435548
Exostosis 12.34 10.06 38 53250 17824 63417910
Peptic ulcer perforation 12.31 10.06 5 53283 188 63435546
Food interaction 12.16 10.06 8 53280 830 63434904
Blood glucose fluctuation 12.13 10.06 17 53271 4559 63431175
Acquired immunodeficiency syndrome 12.00 10.06 4 53284 85 63435649
Clonus 11.96 10.06 17 53271 4619 63431115
Psychotic disorder 11.96 10.06 48 53240 25664 63410070
Bipolar I disorder 11.84 10.06 11 53277 1888 63433846
Subendocardial ischaemia 11.83 10.06 4 53284 89 63435645
Leukopenia 11.75 10.06 30 53258 77260 63358474
Septic shock 11.63 10.06 24 53264 66605 63369129
Feeling abnormal 11.61 10.06 182 53106 148210 63287524
Drug reaction with eosinophilia and systemic symptoms 11.60 10.06 7 53281 33829 63401905
Post-traumatic pain 11.23 10.06 6 53282 424 63435310
Exposure via ingestion 11.18 10.06 13 53275 2896 63432838
Stoma site discomfort 11.10 10.06 4 53284 108 63435626
Underdose 11.02 10.06 49 53239 27407 63408327
Amnesia 10.91 10.06 82 53206 55503 63380231
Bone disorder 10.89 10.06 41 53247 21285 63414449
Live birth 10.79 10.06 4 53284 25626 63410108
Blood albumin decreased 10.75 10.06 32 53256 14734 63421000
Pressure of speech 10.70 10.06 7 53281 719 63435015
Respiratory rate decreased 10.69 10.06 14 53274 3521 63432213
Posturing 10.36 10.06 6 53282 496 63435238
Urinary tract infection 10.30 10.06 293 52995 264391 63171343
Deafness bilateral 10.27 10.06 9 53279 1433 63434301
Renal infarct 10.24 10.06 9 53279 1438 63434296
Cholestasis 10.22 10.06 6 53282 29428 63406306
Labelled drug-drug interaction issue 10.19 10.06 8 53280 1093 63434641
Monoplegia 10.18 10.06 13 53275 3188 63432546

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxicity to various agents 691.98 11.61 862 29814 199500 34726755
Completed suicide 346.18 11.61 428 30248 97740 34828515
Drug abuse 217.11 11.61 344 30332 98752 34827503
Poisoning 116.53 11.61 92 30584 12134 34914121
Overdose 113.24 11.61 248 30428 90811 34835444
Aggression 112.19 11.61 154 30522 38810 34887445
Dysarthria 102.44 11.61 139 30537 34643 34891612
Intrusive thoughts 101.59 11.61 28 30648 287 34925968
Off label use 84.25 11.61 150 30526 419374 34506881
Substance abuse 80.44 11.61 61 30615 7580 34918675
Drug dependence 79.35 11.61 102 30574 24115 34902140
Tachyphrenia 73.25 11.61 31 30645 1238 34925017
Logorrhoea 70.80 11.61 37 30639 2389 34923866
Suicidal ideation 70.67 11.61 127 30549 40261 34885994
Bradyphrenia 65.85 11.61 45 30631 4753 34921502
Homicidal ideation 64.57 11.61 36 30640 2646 34923609
Suicide attempt 62.15 11.61 118 30558 38998 34887257
Psychotic disorder 56.31 11.61 87 30589 24365 34901890
Dystonic tremor 54.95 11.61 16 30660 203 34926052
Depressed level of consciousness 54.67 11.61 118 30558 42723 34883532
Accidental overdose 48.27 11.61 73 30603 20067 34906188
Loss of libido 47.52 11.61 29 30647 2523 34923732
Abnormal behaviour 45.57 11.61 80 30596 24889 34901366
Bradykinesia 45.27 11.61 33 30643 3860 34922395
Insomnia 44.59 11.61 195 30481 103712 34822543
Sedation 44.58 11.61 72 30604 20934 34905321
Pulmonary congestion 43.55 11.61 57 30619 13708 34912547
Respiratory depression 43.43 11.61 62 30614 16183 34910072
Anxiety 42.97 11.61 187 30489 99241 34827014
Anger 40.41 11.61 51 30625 11833 34914422
Injury 38.68 11.61 67 30609 20620 34905635
Restlessness 36.96 11.61 74 30602 25408 34900847
Coordination abnormal 36.38 11.61 39 30637 7605 34918650
Hallucination, auditory 35.63 11.61 48 30628 11869 34914386
Drug ineffective 35.12 11.61 246 30430 456505 34469750
Behaviour disorder 34.49 11.61 31 30645 4879 34921376
Mood swings 33.60 11.61 38 30638 7863 34918392
Drug level below therapeutic 32.81 11.61 32 30644 5583 34920672
Irritability 32.63 11.61 69 30607 24621 34901634
Mental disorder 32.09 11.61 52 30624 15157 34911098
Accidental poisoning 31.81 11.61 15 30661 775 34925480
Paranoia 30.71 11.61 45 30631 12023 34914232
Needle fatigue 30.26 11.61 15 30661 866 34925389
Restless legs syndrome 30.24 11.61 37 30639 8317 34917938
Emotional distress 29.85 11.61 50 30626 14976 34911279
Feelings of worthlessness 29.66 11.61 11 30665 308 34925947
Drug interaction 29.32 11.61 315 30361 225631 34700624
Miosis 27.89 11.61 38 30638 9497 34916758
Relapsing-remitting multiple sclerosis 27.77 11.61 15 30661 1035 34925220
Gait spastic 27.17 11.61 15 30661 1081 34925174
Psychotic behaviour 27.14 11.61 13 30663 696 34925559
Fear 26.57 11.61 39 30637 10437 34915818
Drug withdrawal syndrome 25.71 11.61 55 30621 19779 34906476
Withdrawal syndrome 25.49 11.61 42 30634 12413 34913842
Crystalluria 25.29 11.61 11 30665 470 34925785
Thinking abnormal 25.22 11.61 29 30647 6108 34920147
Depression 24.86 11.61 158 30518 96940 34829315
Hypertonic bladder 24.44 11.61 17 30659 1847 34924408
Obsessive-compulsive disorder 24.07 11.61 27 30649 5537 34920718
Agitation 24.04 11.61 107 30569 57292 34868963
Dissociation 23.82 11.61 16 30660 1642 34924613
COVID-19 23.60 11.61 20 30656 77530 34848725
Depressed mood 23.26 11.61 52 30624 19265 34906990
Cardio-respiratory arrest 23.12 11.61 103 30573 55170 34871085
General physical health deterioration 22.88 11.61 49 30627 128220 34798035
Mesothelioma 22.82 11.61 10 30666 435 34925820
Congestive hepatopathy 22.00 11.61 16 30660 1865 34924390
Arteriosclerosis coronary artery 21.49 11.61 39 30637 12446 34913809
Homicide 20.85 11.61 12 30664 937 34925318
Febrile neutropenia 20.68 11.61 57 30619 136792 34789463
Drug abuser 20.28 11.61 21 30655 3933 34922322
Osmolar gap abnormal 20.22 11.61 5 30671 32 34926223
Emotional disorder 20.18 11.61 25 30651 5691 34920564
Abulia 19.97 11.61 10 30666 590 34925665
Memory impairment 19.86 11.61 83 30593 43235 34883020
Interstitial lung disease 19.66 11.61 17 30659 65265 34860990
Panic attack 19.56 11.61 32 30644 9400 34916855
Antasthmatic drug level 19.25 11.61 5 30671 40 34926215
Analgesic drug level 18.93 11.61 5 30671 43 34926212
Somnambulism 18.88 11.61 18 30658 3054 34923201
Monoparesis 18.87 11.61 16 30660 2330 34923925
Drug screen positive 18.55 11.61 20 30656 3923 34922332
Cardiac asthma 18.03 11.61 7 30669 223 34926032
Somnolence 17.82 11.61 162 30514 110954 34815301
Personality change 17.38 11.61 22 30654 5117 34921138
Amnesia 17.30 11.61 57 30619 26506 34899749
Pulmonary oedema 17.26 11.61 85 30591 47444 34878811
Depersonalisation/derealisation disorder 17.16 11.61 9 30667 585 34925670
Decreased interest 16.77 11.61 15 30661 2345 34923910
Confusional state 16.40 11.61 196 30480 143964 34782291
Joint swelling 16.39 11.61 17 30659 59873 34866382
Intentional product use issue 16.35 11.61 17 30659 59799 34866456
Conduction disorder 16.18 11.61 14 30662 2096 34924159
Dissociative disorder 16.15 11.61 8 30668 461 34925794
Sexually transmitted disease 16.12 11.61 4 30672 26 34926229
Patient uncooperative 16.05 11.61 8 30668 467 34925788
Blood disorder 15.76 11.61 17 30659 3337 34922918
Thalassaemia 15.51 11.61 4 30672 31 34926224
Hepatic function abnormal 15.35 11.61 10 30666 44353 34881902
Renal impairment 15.31 11.61 38 30638 94475 34831780
Lethargy 15.25 11.61 74 30602 41048 34885207
Diarrhoea 15.15 11.61 246 30430 389666 34536589
Muscle spasticity 15.04 11.61 22 30654 5866 34920389
Pyrexia 14.68 11.61 205 30471 332808 34593447
Victim of crime 14.59 11.61 7 30669 376 34925879
Reduced facial expression 14.42 11.61 10 30666 1081 34925174
Unresponsive to stimuli 14.38 11.61 55 30621 27514 34898741
Accidental death 14.35 11.61 14 30662 2442 34923813
Physical disability 14.35 11.61 11 30665 1388 34924867
Vestibular disorder 14.29 11.61 10 30666 1097 34925158
Nervousness 14.14 11.61 33 30643 12573 34913682
Tangentiality 14.13 11.61 5 30671 122 34926133
Gun shot wound 14.12 11.61 10 30666 1118 34925137
Nocturia 14.03 11.61 29 30647 10181 34916074
Foetal exposure during pregnancy 14.00 11.61 8 30668 38093 34888162
Exposure via ingestion 13.82 11.61 13 30663 2168 34924087
Gait disturbance 13.57 11.61 124 30552 85016 34841239
Adjustment disorder 13.56 11.61 10 30666 1191 34925064
Cerebral arteriovenous malformation haemorrhagic 13.51 11.61 4 30672 54 34926201
Condition aggravated 13.49 11.61 106 30570 192090 34734165
Hallucination, visual 13.26 11.61 40 30636 17751 34908504
Iron metabolism disorder 13.18 11.61 4 30672 59 34926196
Treatment failure 13.07 11.61 13 30663 46684 34879571
Contraindication to medical treatment 13.02 11.61 8 30668 704 34925551
Acute kidney injury 12.99 11.61 189 30487 304799 34621456
Dysprosody 12.76 11.61 3 30673 15 34926240
Cardiomegaly 12.74 11.61 36 30640 15402 34910853
Sexually inappropriate behaviour 12.67 11.61 7 30669 505 34925750
Inappropriate schedule of product administration 12.66 11.61 22 30654 62274 34863981
Cognitive disorder 12.39 11.61 54 30622 28639 34897616
Multiple organ dysfunction syndrome 12.23 11.61 31 30645 76535 34849720
Micturition urgency 12.02 11.61 21 30655 6504 34919751
Cytomegalovirus infection 11.96 11.61 4 30672 26131 34900124
Hospitalisation 11.65 11.61 20 30656 56882 34869373

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
Toxicity to various agents 991.48 10.19 1494 67216 420046 79255632
Completed suicide 822.37 10.19 1034 67676 244733 79430945
Temperature regulation disorder 317.24 10.19 136 68574 5717 79669961
Overdose 305.95 10.19 560 68150 183646 79492032
Drug abuse 264.30 10.19 490 68220 162201 79513477
Coeliac disease 250.50 10.19 143 68567 11208 79664470
Food allergy 232.55 10.19 134 68576 10690 79664988
Poisoning 179.03 10.19 159 68551 25113 79650565
Immunodeficiency 156.27 10.19 138 68572 21630 79654048
Substance abuse 130.27 10.19 92 68618 10434 79665244
Off label use 126.61 10.19 383 68327 906832 78768846
Bursitis 121.22 10.19 152 68558 35692 79639986
Accidental overdose 103.43 10.19 148 68562 39433 79636245
Respiratory arrest 103.07 10.19 181 68529 57369 79618309
Respiratory depression 101.23 10.19 122 68588 27508 79648170
Synovitis 99.69 10.19 8 68702 150726 79524952
Aggression 97.45 10.19 165 68545 50793 79624885
Fluid retention 97.00 10.19 197 68513 69612 79606066
Drug ineffective 95.95 10.19 544 68166 1080369 78595309
Hyperhidrosis 95.06 10.19 317 68393 151175 79524503
Rash erythematous 87.46 10.19 169 68541 57600 79618078
Myocardial depression 83.66 10.19 27 68683 502 79675176
Drug dependence 81.95 10.19 135 68575 40634 79635044
Death 81.10 10.19 794 67916 565720 79109958
Cardio-respiratory arrest 79.91 10.19 240 68470 108270 79567408
Intrusive thoughts 79.84 10.19 26 68684 498 79675180
Dysarthria 79.16 10.19 178 68532 67444 79608234
Pemphigus 72.79 10.19 3 68707 99579 79576099
Homicidal ideation 72.13 10.19 42 68668 3415 79672263
Suicidal ideation 70.13 10.19 183 68527 76157 79599521
Decorticate posture 68.89 10.19 21 68689 321 79675357
Maternal exposure during pregnancy 67.83 10.19 17 68693 136521 79539157
Hand deformity 67.37 10.19 6 68704 103913 79571765
Arthropathy 66.17 10.19 35 68675 177076 79498602
Tachyphrenia 64.93 10.19 33 68677 2047 79673631
Logorrhoea 63.12 10.19 42 68668 4323 79671355
Abnormal behaviour 61.93 10.19 112 68598 36309 79639369
Pulmonary congestion 60.30 10.19 94 68616 27006 79648672
Anti-cyclic citrullinated peptide antibody positive 59.15 10.19 3 68707 83140 79592538
Irritability 57.01 10.19 116 68594 41028 79634650
Discomfort 56.24 10.19 19 68691 125598 79550080
Cardiac arrest 55.67 10.19 294 68416 171802 79503876
Dystonic tremor 55.23 10.19 16 68694 203 79675475
Miosis 53.44 10.19 67 68643 15722 79659956
Mental disorder 52.89 10.19 96 68614 31206 79644472
Victim of sexual abuse 52.23 10.19 19 68691 513 79675165
General physical health deterioration 51.81 10.19 99 68611 275139 79400539
Insomnia 49.94 10.19 372 68338 244798 79430880
Back pain 49.24 10.19 438 68272 303742 79371936
Intentional overdose 49.01 10.19 201 68509 105759 79569919
Drug intolerance 48.84 10.19 96 68614 264023 79411655
Arthralgia 48.23 10.19 292 68418 571511 79104167
Swelling 48.14 10.19 70 68640 216641 79459037
Suicide attempt 48.00 10.19 169 68541 82763 79592915
Rectal polyp 47.72 10.19 25 68685 1652 79674026
Judgement impaired 47.63 10.19 23 68687 1277 79674401
Mood swings 47.11 10.19 71 68639 19809 79655869
Loss of libido 46.65 10.19 29 68681 2656 79673022
Libido increased 46.28 10.19 26 68684 1975 79673703
Pericarditis 46.25 10.19 16 68694 104220 79571458
Asthma 45.90 10.19 234 68476 134861 79540817
Psychotic disorder 45.15 10.19 106 68604 41296 79634382
Upper respiratory tract infection 44.60 10.19 176 68534 90992 79584686
Depressed level of consciousness 44.43 10.19 183 68527 96469 79579209
Arteriosclerosis coronary artery 44.18 10.19 65 68645 17751 79657927
Homicide 43.51 10.19 21 68689 1165 79674513
Behaviour disorder 43.27 10.19 39 68671 6274 79669404
Coma scale abnormal 43.25 10.19 45 68665 8633 79667045
Hostility 42.81 10.19 26 68684 2284 79673394
Intentional product use issue 42.48 10.19 41 68669 152071 79523607
Bradyphrenia 42.31 10.19 49 68661 10591 79665087
Anxiety 41.84 10.19 361 68349 248151 79427527
Soft tissue injury 40.81 10.19 23 68687 1758 79673920
Sternal fracture 40.63 10.19 26 68684 2504 79673174
Withdrawal syndrome 39.95 10.19 78 68632 26776 79648902
Post-traumatic neck syndrome 39.92 10.19 24 68686 2070 79673608
Interstitial lung disease 39.53 10.19 24 68686 112576 79563102
Peripheral swelling 39.44 10.19 111 68599 269506 79406172
Glossodynia 39.21 10.19 20 68690 103317 79572361
Change of bowel habit 38.60 10.19 26 68684 2731 79672947
Somnolence 38.08 10.19 343 68367 238638 79437040
Restlessness 37.24 10.19 106 68604 46386 79629292
Constipation 37.13 10.19 390 68320 282660 79393018
Depression 36.52 10.19 315 68395 216475 79459203
Accidental death 36.51 10.19 30 68680 4261 79671417
Drug withdrawal syndrome 35.82 10.19 87 68623 34631 79641047
Unresponsive to stimuli 35.18 10.19 117 68593 55671 79620007
Rheumatoid factor positive 34.91 10.19 5 68705 59834 79615844
Rash 34.63 10.19 325 68385 578033 79097645
Gait spastic 34.50 10.19 18 68692 1179 79674499
Bradykinesia 33.60 10.19 38 68672 8005 79667673
Systemic lupus erythematosus 33.42 10.19 33 68677 121116 79554562
Paranoia 33.34 10.19 60 68650 19372 79656306
Drug abuser 33.29 10.19 33 68677 5980 79669698
Sedation 32.87 10.19 109 68601 51786 79623892
Memory impairment 32.82 10.19 186 68524 111548 79564130
Amblyopia 32.57 10.19 11 68699 237 79675441
Abdominal discomfort 32.55 10.19 109 68601 250618 79425060
Nasopharyngitis 32.53 10.19 111 68599 253770 79421908
Sensitisation 32.12 10.19 25 68685 3286 79672392
Kyphosis 32.10 10.19 23 68687 2668 79673010
Impaired reasoning 32.08 10.19 9 68701 101 79675577
Folliculitis 31.45 10.19 5 68705 55375 79620303
Infusion related reaction 31.34 10.19 98 68612 230139 79445539
COVID-19 31.17 10.19 55 68655 157619 79518059
Urine odour abnormal 30.32 10.19 32 68678 6241 79669437
Febrile neutropenia 30.28 10.19 100 68610 230899 79444779
Needle fatigue 30.18 10.19 15 68695 887 79674791
Therapeutic product effect decreased 29.89 10.19 60 68650 163803 79511875
Toxicologic test abnormal 29.64 10.19 17 68693 1343 79674335
Coordination abnormal 29.12 10.19 53 68657 17259 79658419
Duodenal ulcer 28.67 10.19 51 68659 16318 79659360
Victim of crime 28.64 10.19 12 68698 476 79675202
Neutropenia 28.57 10.19 139 68571 287571 79388107
Thiopurine methyltransferase decreased 28.39 10.19 11 68699 355 79675323
Wound 28.35 10.19 35 68675 116144 79559534
Condition aggravated 28.13 10.19 286 68424 500838 79174840
Duodenal ulcer perforation 27.96 10.19 11 68699 66200 79609478
Drug screen positive 27.67 10.19 30 68680 6033 79669645
Frustration tolerance decreased 27.27 10.19 33 68677 7469 79668209
Venous pressure jugular increased 27.22 10.19 16 68694 1324 79674354
Intentional product misuse 27.02 10.19 157 68553 95008 79580670
Poor quality sleep 26.79 10.19 60 68650 22662 79653016
Mental impairment 26.76 10.19 54 68656 18982 79656696
Rib fracture 26.69 10.19 68 68642 27879 79647799
Transplant dysfunction 26.63 10.19 32 68678 7189 79668489
Depressed mood 26.52 10.19 97 68613 48383 79627295
Urticaria 26.51 10.19 77 68633 185124 79490554
Mass 26.29 10.19 51 68659 17421 79658257
Cytomegalovirus infection 26.24 10.19 3 68707 42641 79633037
Blister 26.12 10.19 39 68671 119437 79556241
Personality disorder 25.61 10.19 29 68681 6117 79669561
Hepatocellular injury 25.50 10.19 5 68705 47588 79628090
Relapsing-remitting multiple sclerosis 25.37 10.19 16 68694 1503 79674175
Obsessive-compulsive disorder 24.76 10.19 28 68682 5899 79669779
Rectal prolapse 24.58 10.19 18 68692 2160 79673518
Anger 24.50 10.19 49 68661 17113 79658565
Myelosuppression 24.38 10.19 3 68707 40293 79635385
Injection site discomfort 24.34 10.19 26 68684 5140 79670538
Exposure via ingestion 24.31 10.19 26 68684 5148 79670530
Psoriatic arthropathy 24.22 10.19 19 68691 77980 79597698
Proctalgia 24.09 10.19 36 68674 9965 79665713
Foetal death 23.89 10.19 32 68678 8012 79667666
Restless legs syndrome 23.62 10.19 53 68657 20039 79655639
Acute kidney injury 23.48 10.19 311 68399 519093 79156585
Pruritus 23.06 10.19 223 68487 394425 79281253
Thinking abnormal 23.04 10.19 41 68669 13120 79662558
Liver injury 22.94 10.19 10 68700 56604 79619074
Pulmonary oedema 22.76 10.19 142 68568 88112 79587566
Infection 22.72 10.19 119 68591 241593 79434085
Stomatitis 22.51 10.19 59 68651 146698 79528980
Apnoea 22.50 10.19 38 68672 11666 79664012
Blood glucose decreased 22.17 10.19 61 68649 26173 79649505
Somnambulism 22.17 10.19 26 68684 5695 79669983
Bruxism 22.11 10.19 22 68688 4004 79671674
Musculoskeletal stiffness 22.08 10.19 77 68633 174931 79500747
C-reactive protein increased 22.06 10.19 49 68661 128978 79546700
Accidental poisoning 21.71 10.19 15 68695 1642 79674036
Alopecia 21.69 10.19 114 68596 231241 79444437
Psychotic behaviour 21.68 10.19 13 68697 1116 79674562
Intestinal haemorrhage 21.32 10.19 27 68683 6399 79669279
Urine oxalate increased 21.16 10.19 8 68702 241 79675437
Emotional distress 21.05 10.19 79 68631 39890 79635788
Myelocyte percentage increased 21.01 10.19 8 68702 246 79675432
Feelings of worthlessness 20.93 10.19 10 68700 542 79675136
Therapeutic product effect incomplete 20.93 10.19 58 68652 141587 79534091
Delusion 20.87 10.19 51 68659 20372 79655306
Furuncle 20.84 10.19 29 68681 7525 79668153
Polyp 20.71 10.19 30 68680 8077 79667601
Diarrhoea 20.52 10.19 590 68120 879899 78795779
Mobility decreased 20.40 10.19 47 68663 122128 79553550
Ovarian cyst 20.35 10.19 38 68672 12617 79663061
Hypothermia 20.34 10.19 54 68656 22692 79652986
Poisoning deliberate 20.30 10.19 48 68662 18780 79656898
Panic attack 20.16 10.19 56 68654 24160 79651518
Band neutrophil percentage increased 20.10 10.19 9 68701 420 79675258
Cardiomegaly 20.06 10.19 59 68651 26293 79649385
Tremor 19.82 10.19 229 68481 169854 79505824
Loss of consciousness 19.51 10.19 226 68484 167717 79507961
Antasthmatic drug level 19.34 10.19 5 68705 40 79675638
Septic shock 19.11 10.19 49 68661 122752 79552926
Retinal depigmentation 19.10 10.19 8 68702 317 79675361
Antidepressant drug level above therapeutic 19.01 10.19 10 68700 666 79675012
Urine abnormality 18.97 10.19 29 68681 8190 79667488
Analgesic drug level 18.81 10.19 5 68705 45 79675633
Postmortem blood drug level 18.57 10.19 8 68702 340 79675338
Knee arthroplasty 18.57 10.19 7 68703 43241 79632437
Sinusitis 18.51 10.19 96 68614 195405 79480273
Agitation 18.43 10.19 148 68562 99567 79576111
Prescribed overdose 18.41 10.19 73 68637 37810 79637868
Crystalluria 18.39 10.19 11 68699 940 79674738
Dilatation atrial 18.09 10.19 19 68691 3685 79671993
Infected dermal cyst 17.94 10.19 12 68698 1246 79674432
Amnesia 17.88 10.19 104 68606 62953 79612725
Hepatic function abnormal 17.86 10.19 22 68688 73085 79602593
Drug resistance 17.84 10.19 7 68703 42206 79633472
Hypertonic bladder 17.81 10.19 20 68690 4181 79671497
Iron metabolism disorder 17.67 10.19 5 68705 58 79675620
Dystrophic calcification 17.60 10.19 6 68704 133 79675545
Feeling abnormal 17.51 10.19 212 68498 158987 79516691
Lethargy 17.47 10.19 125 68585 81167 79594511
Joint swelling 17.32 10.19 162 68548 288484 79387194
Alcohol poisoning 17.19 10.19 21 68689 4800 79670878
Cholestasis 17.07 10.19 12 68698 52097 79623581
Pyrexia 17.02 10.19 450 68260 678259 78997419
Mania 16.99 10.19 44 68666 18216 79657462
Nightmare 16.98 10.19 55 68655 25806 79649872
Ill-defined disorder 16.98 10.19 19 68691 65856 79609822
Congestive hepatopathy 16.52 10.19 20 68690 4527 79671151
Decreased interest 16.36 10.19 18 68692 3679 79671999
Pneumocystis jirovecii pneumonia 16.23 10.19 4 68706 32504 79643174
Movement disorder 16.15 10.19 56 68654 27203 79648475
Band neutrophil count increased 16.05 10.19 9 68701 681 79674997
Irritable bowel syndrome 15.99 10.19 18 68692 62223 79613455
Gastrointestinal disorder 15.93 10.19 53 68657 122152 79553526
Fibrinolysis 15.70 10.19 5 68705 89 79675589
Akathisia 15.61 10.19 35 68675 13224 79662454
Fear 15.58 10.19 48 68662 21938 79653740
Treatment failure 15.42 10.19 85 68625 170401 79505277
Monoparesis 15.37 10.19 17 68693 3494 79672184
Bladder disorder 15.34 10.19 28 68682 9137 79666541
Rheumatic fever 15.27 10.19 3 68707 28522 79647156
Osmolar gap abnormal 15.25 10.19 5 68705 98 79675580
Abulia 15.20 10.19 10 68700 1010 79674668
Anaemia 15.17 10.19 281 68429 444734 79230944
Drug interaction 15.03 10.19 466 68244 414717 79260961
Rebound psychosis 14.87 10.19 7 68703 367 79675311
Product use in unapproved indication 14.80 10.19 141 68569 250218 79425460
Postmortem blood drug level increased 14.72 10.19 9 68701 800 79674878
Herpes zoster 14.59 10.19 37 68673 93046 79582632
Hallucination, auditory 14.50 10.19 45 68665 20648 79655030
Mucosal inflammation 14.36 10.19 27 68683 75553 79600125
Hospitalisation 14.36 10.19 38 68672 94198 79581480
Bundle branch block left 14.25 10.19 31 68679 11482 79664196
Flight of ideas 14.20 10.19 9 68701 853 79674825
Upper respiratory tract congestion 13.88 10.19 14 68696 2589 79673089
Ventricular hypokinesia 13.86 10.19 27 68683 9252 79666426
Pancytopenia 13.73 10.19 85 68625 165660 79510018
Emotional disorder 13.73 10.19 35 68675 14352 79661326
Oesophagitis ulcerative 13.70 10.19 10 68700 1193 79674485
Blood pressure fluctuation 13.65 10.19 23 68687 67122 79608556
Bacterial test 13.56 10.19 10 68700 1213 79674465
Pressure of speech 13.52 10.19 10 68700 1218 79674460
Concussion 13.41 10.19 27 68683 9476 79666202
Micturition urgency 13.38 10.19 32 68678 12609 79663069
Drug eruption 13.27 10.19 11 68699 43924 79631754
Thalassaemia 13.25 10.19 4 68706 59 79675619
Cardiac asthma 13.18 10.19 6 68704 291 79675387
Thyroid disorder 13.18 10.19 34 68676 14045 79661633
Patient uncooperative 13.14 10.19 8 68702 706 79674972
Arteriosclerosis 13.11 10.19 40 68670 18187 79657491
Analgesic drug level above therapeutic 13.09 10.19 7 68703 482 79675196
Opiates positive 12.95 10.19 9 68701 995 79674683
Seasonal affective disorder 12.92 10.19 6 68704 305 79675373
Cardiomyopathy 12.84 10.19 54 68656 28720 79646958
Dysprosody 12.81 10.19 3 68707 15 79675663
Neurotoxicity 12.78 10.19 6 68704 32512 79643166
Nocturia 12.76 10.19 33 68677 13648 79662030
Lip swelling 12.66 10.19 10 68700 40901 79634777
Thrombocytopenia 12.63 10.19 157 68553 265102 79410576
Myelocyte count increased 12.59 10.19 8 68702 761 79674917
Coronary artery disease 12.55 10.19 98 68612 65376 79610302
Breast cancer male 12.53 10.19 6 68704 327 79675351
Muscle injury 12.52 10.19 14 68696 48547 79627131
Sexually inappropriate behaviour 12.38 10.19 7 68703 538 79675140
Chronic obstructive pulmonary disease 12.28 10.19 120 68590 85299 79590379
Tangentiality 12.26 10.19 5 68705 185 79675493
Transaminases increased 12.19 10.19 16 68694 51727 79623951
Impaired healing 12.14 10.19 37 68673 87618 79588060
Dissociative disorder 12.11 10.19 8 68702 813 79674865
Multiple sclerosis relapse 12.07 10.19 75 68635 46458 79629220
Mesothelioma 12.02 10.19 6 68704 358 79675320
Musculoskeletal discomfort 11.97 10.19 41 68669 19794 79655884
Hypovolaemia 11.96 10.19 38 68672 17653 79658025
Suspected counterfeit product 11.91 10.19 7 68703 579 79675099
Lung disorder 11.88 10.19 33 68677 80524 79595154
Gun shot wound 11.71 10.19 9 68701 1161 79674517
Asphyxia 11.69 10.19 29 68681 11691 79663987
Gallbladder disorder 11.69 10.19 40 68670 19300 79656378
Hyperlipidaemia 11.66 10.19 49 68661 26044 79649634
Dehydration 11.63 10.19 288 68422 247899 79427779
Specific gravity urine decreased 11.63 10.19 8 68702 870 79674808
Cyclothymic disorder 11.60 10.19 5 68705 213 79675465
Intentional product misuse to child 11.56 10.19 4 68706 93 79675585
Peripheral coldness 11.44 10.19 35 68675 15935 79659743
Ventricular hypertrophy 11.37 10.19 21 68689 6917 79668761
Hypokalaemia 11.35 10.19 75 68635 143965 79531713
Schizophrenia 11.21 10.19 34 68676 15406 79660272
Exostosis 11.20 10.19 36 68674 16822 79658856
Accident 11.18 10.19 24 68686 8807 79666871
Exposure during pregnancy 11.14 10.19 47 68663 101085 79574593
Bone disorder 11.10 10.19 39 68671 19074 79656604
Conduction disorder 10.90 10.19 14 68696 3365 79672313
Gamma-glutamyltransferase increased 10.87 10.19 19 68691 54661 79621017
Injection site erythema 10.83 10.19 33 68677 78164 79597514
Cardioactive drug level above therapeutic 10.83 10.19 5 68705 251 79675427
Inappropriate schedule of product administration 10.82 10.19 69 68641 133559 79542119
Postoperative wound infection 10.82 10.19 30 68680 12931 79662747
Abortion spontaneous 10.76 10.19 6 68704 29501 79646177
Therapy non-responder 10.73 10.19 42 68668 92263 79583415
Inflammation 10.68 10.19 43 68667 93710 79581968
Fall 10.67 10.19 518 68192 487111 79188567
Subendocardial ischaemia 10.66 10.19 4 68706 118 79675560
Mental status changes 10.59 10.19 96 68614 66863 79608815
Bipolar I disorder 10.54 10.19 11 68699 2118 79673560
Hepatic steatosis 10.54 10.19 62 68648 37676 79638002
Middle insomnia 10.39 10.19 34 68676 16035 79659643
Erectile dysfunction 10.37 10.19 32 68678 14632 79661046
Grip strength decreased 10.33 10.19 3 68707 21866 79653812
Arrhythmia 10.28 10.19 89 68621 61183 79614495

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N05CD07 NERVOUS SYSTEM
PSYCHOLEPTICS
HYPNOTICS AND SEDATIVES
Benzodiazepine derivatives
FDA CS M0002356 Benzodiazepines
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
FDA EPC N0000175694 Benzodiazepine

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

DiseaseRelationSNOMED_IDDOID
Insomnia indication 193462001
Suicidal thoughts contraindication 6471006
Alcohol intoxication contraindication 25702006
Depressive disorder contraindication 35489007
Substance abuse contraindication 66214007
Sleep apnea contraindication 73430006 DOID:0050847
Kidney disease contraindication 90708001 DOID:557
Hypoalbuminemia contraindication 119247004
Disease of liver contraindication 235856003 DOID:409
Sleep automatism contraindication 247962006
Pregnancy, function contraindication 289908002
Severe chronic obstructive pulmonary disease contraindication 313299006
Memory impairment contraindication 386807006
Chronic lung disease contraindication 413839001




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 9.07 acidic
pKa2 1.46 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
GABA-A receptor alpha-1/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR WOMBAT-PK CHEMBL
Nuclear receptor subfamily 1 group I member 3 Nuclear hormone receptor WOMBAT-PK

External reference:

IDSource
4017894 VUID
N0000146246 NUI
D00370 KEGG_DRUG
4017894 VANDF
C0039468 UMLSCUI
CHEBI:9435 CHEBI
CHEMBL967 ChEMBL_ID
DB00231 DRUGBANK_ID
D013693 MESH_DESCRIPTOR_UI
5391 PUBCHEM_CID
7300 IUPHAR_LIGAND_ID
2753 INN_ID
CHB1QD2QSS UNII
10355 RXNORM
2322 MMSL
5544 MMSL
d00384 MMSL
001450 NDDF
387300007 SNOMEDCT_US
54705000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 0228-2076 CAPSULE 15 mg ORAL ANDA 19 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 0228-2076 CAPSULE 15 mg ORAL ANDA 19 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 0228-2077 CAPSULE 30 mg ORAL ANDA 19 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 0228-2077 CAPSULE 30 mg ORAL ANDA 19 sections
RESTORIL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9914 CAPSULE 22.50 mg ORAL NDA 26 sections
RESTORIL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9914 CAPSULE 22.50 mg ORAL NDA 26 sections
RESTORIL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9915 CAPSULE 7.50 mg ORAL NDA 26 sections
RESTORIL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9915 CAPSULE 7.50 mg ORAL NDA 26 sections
RESTORIL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9916 CAPSULE 15 mg ORAL NDA 26 sections
RESTORIL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9916 CAPSULE 15 mg ORAL NDA 26 sections
RESTORIL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9917 CAPSULE 30 mg ORAL NDA 26 sections
RESTORIL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9917 CAPSULE 30 mg ORAL NDA 26 sections
TEMAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9959 CAPSULE 22.50 mg ORAL NDA 26 sections
TEMAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9959 CAPSULE 22.50 mg ORAL NDA 26 sections
TEMAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9960 CAPSULE 7.50 mg ORAL NDA 26 sections
TEMAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9960 CAPSULE 7.50 mg ORAL NDA 26 sections
TEMAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9961 CAPSULE 15 mg ORAL NDA 26 sections
TEMAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9961 CAPSULE 15 mg ORAL NDA 26 sections
TEMAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9962 CAPSULE 30 mg ORAL NDA 26 sections
TEMAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 0406-9962 CAPSULE 30 mg ORAL NDA 26 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 0615-7808 CAPSULE 15 mg ORAL ANDA 27 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 0615-7809 CAPSULE 30 mg ORAL ANDA 27 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 0904-6436 CAPSULE 7.50 mg ORAL ANDA 24 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 0904-6436 CAPSULE 7.50 mg ORAL ANDA 24 sections
TEMAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 16590-214 CAPSULE 15 mg ORAL ANDA 14 sections
temazepam Human Prescription Drug Label 1 17856-0148 CAPSULE 15 mg ORAL ANDA 23 sections
temazepam HUMAN PRESCRIPTION DRUG LABEL 1 21695-282 CAPSULE 15 mg ORAL ANDA 24 sections
temazepam HUMAN PRESCRIPTION DRUG LABEL 1 21695-283 CAPSULE 30 mg ORAL ANDA 24 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 33261-101 CAPSULE 15 mg ORAL ANDA 23 sections
Temazepam HUMAN PRESCRIPTION DRUG LABEL 1 33261-102 CAPSULE 30 mg ORAL ANDA 23 sections