methadone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
1728 76-99-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • metadone
  • methadone
  • methadone hydrochloride
  • methadone HCl
A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)
  • Molecular weight: 309.45
  • Formula: C21H27NO
  • CLOGP: 4.17
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 0
  • TPSA: 20.31
  • ALOGS: -4.72
  • ROTB: 7
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
25 mg O
25 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 120 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 24 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.62 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 92 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 4.40 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.21 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 31 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 13, 1947 FDA ROXANE

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug abuse 2499.80 12.56 1001 25928 58845 50519350
Toxicity to various agents 1698.09 12.56 1170 25759 211329 50366866
Completed suicide 605.51 12.56 525 26404 131364 50446831
Exposure during pregnancy 601.00 12.56 504 26425 120511 50457684
Cardio-respiratory arrest 479.74 12.56 319 26610 53573 50524622
Respiratory arrest 454.69 12.56 250 26679 29759 50548436
Death 453.40 12.56 698 26231 324681 50253514
Cardiac arrest 349.23 12.56 316 26613 83335 50494860
Premature delivery 341.55 12.56 191 26738 23472 50554723
Respiratory depression 314.42 12.56 145 26784 11865 50566330
Torsade de pointes 264.09 12.56 128 26801 11707 50566488
Premature labour 252.70 12.56 123 26806 11353 50566842
Poisoning 246.33 12.56 124 26805 12305 50565890
Intentional product misuse 238.21 12.56 198 26731 46536 50531659
Overdose 236.39 12.56 278 26651 99449 50478746
Drug withdrawal syndrome 216.96 12.56 146 26783 24935 50553260
Drug dependence 182.91 12.56 120 26809 19639 50558556
Accidental overdose 153.05 12.56 107 26822 19426 50558769
Drug withdrawal syndrome neonatal 139.82 12.56 48 26881 1793 50576402
Drug interaction 135.54 12.56 316 26613 199305 50378890
Maternal exposure during pregnancy 129.98 12.56 272 26657 159506 50418689
Electrocardiogram QT prolonged 125.02 12.56 146 26783 51740 50526455
Drug diversion 121.32 12.56 35 26894 730 50577465
Withdrawal syndrome 116.43 12.56 87 26842 17503 50560692
Hyperaesthesia 107.15 12.56 62 26867 8111 50570084
Unresponsive to stimuli 101.55 12.56 102 26827 30507 50547688
Exposure via ingestion 99.71 12.56 42 26887 2761 50575434
Delirium 70.39 12.56 94 26835 38098 50540097
Depressed level of consciousness 68.30 12.56 109 26820 51844 50526351
Somnolence 67.18 12.56 208 26721 154777 50423418
Substance abuse 66.93 12.56 36 26893 4088 50574107
Miosis 64.98 12.56 41 26888 6269 50571926
Coma 61.04 12.56 109 26820 56770 50521425
Accidental exposure to product by child 59.58 12.56 22 26907 1018 50577177
Chorea 54.16 12.56 22 26907 1318 50576877
Toxic leukoencephalopathy 53.68 12.56 18 26911 625 50577570
Asphyxia 52.74 12.56 34 26895 5393 50572802
Leukoencephalopathy 52.34 12.56 30 26899 3853 50574342
Mental status changes 51.70 12.56 79 26850 36193 50542002
Foetal exposure during pregnancy 51.42 12.56 68 26861 27291 50550904
Rash 50.35 12.56 98 26831 437373 50140822
Glossodynia 49.50 12.56 3 26926 115566 50462629
Rheumatoid arthritis 49.39 12.56 23 26906 202527 50375668
Systemic lupus erythematosus 49.03 12.56 8 26921 140614 50437581
Drug use disorder 47.58 12.56 26 26903 3046 50575149
Bradypnoea 47.56 12.56 26 26903 3048 50575147
Abdominal discomfort 45.62 12.56 34 26895 231607 50346588
Accidental death 45.44 12.56 21 26908 1723 50576472
Affective disorder 44.38 12.56 30 26899 5151 50573044
Alopecia 43.28 12.56 40 26889 245007 50333188
Hand deformity 41.73 12.56 3 26926 100196 50477999
Joint swelling 41.05 12.56 42 26887 245244 50332951
Drug screen positive 39.85 12.56 24 26905 3378 50574817
Suspected counterfeit product 39.31 12.56 12 26917 306 50577889
Synovitis 39.05 12.56 9 26920 123856 50454339
Infusion related reaction 38.70 12.56 21 26908 169536 50408659
Drug intolerance 38.41 12.56 36 26893 219068 50359127
Exposure via breast milk 37.69 12.56 18 26911 1590 50576605
Cough 37.40 12.56 44 26885 241220 50336975
Infection 37.23 12.56 23 26906 172931 50405264
Sedation 37.20 12.56 62 26867 30548 50547647
Hypersensitivity 36.96 12.56 36 26893 215125 50363070
Arthropathy 35.40 12.56 20 26909 157886 50420309
Swelling 34.05 12.56 34 26895 200838 50377357
Nasopharyngitis 33.45 12.56 32 26897 192895 50385300
Drug ineffective 33.36 12.56 278 26651 819055 49759140
Contraindicated product administered 33.20 12.56 19 26910 148939 50429256
Ventricular tachycardia 32.35 12.56 41 26888 15780 50562415
Cyanosis 32.08 12.56 40 26889 15144 50563051
Poisoning deliberate 31.19 12.56 29 26900 7883 50570312
Sinusitis 31.10 12.56 27 26902 170531 50407664
Atrial fibrillation 30.89 12.56 8 26921 101737 50476458
Congenital nystagmus 30.35 12.56 5 26924 3 50578192
Discomfort 30.19 12.56 10 26919 108370 50469825
Diarrhoea 30.04 12.56 187 26742 588289 49989906
Long QT syndrome 29.85 12.56 19 26910 2948 50575247
Neurological examination abnormal 29.77 12.56 9 26920 222 50577973
Respiratory acidosis 29.55 12.56 25 26904 6003 50572192
Wound 29.06 12.56 10 26919 105784 50472411
Contusion 28.49 12.56 12 26917 112171 50466024
Cardio-respiratory distress 28.43 12.56 8 26921 152 50578043
Therapeutic product effect decreased 28.03 12.56 19 26910 136031 50442164
Low birth weight baby 28.03 12.56 24 26905 5857 50572338
Suicidal ideation 27.43 12.56 78 26851 55307 50522888
Pruritus 27.25 12.56 70 26859 283498 50294697
Arthralgia 26.38 12.56 132 26797 438570 50139625
Intentional overdose 26.21 12.56 83 26846 62421 50515774
Lower respiratory tract infection 26.14 12.56 9 26920 95192 50483003
Cerebral vasoconstriction 26.02 12.56 12 26917 980 50577215
Agitation 25.29 12.56 74 26855 53310 50524885
Treatment failure 24.83 12.56 22 26907 137615 50440580
Crying 24.33 12.56 41 26888 20375 50557820
Urticaria 24.24 12.56 20 26909 129541 50448654
Gastrointestinal disorder 24.15 12.56 10 26919 94446 50483749
Post-anoxic myoclonus 23.92 12.56 5 26924 24 50578171
Emotional distress 23.46 12.56 49 26880 28614 50549581
Substance use disorder 22.53 12.56 6 26923 92 50578103
Pulmonary oedema 22.39 12.56 67 26862 48871 50529324
Stress cardiomyopathy 22.05 12.56 24 26905 7863 50570332
Basal ganglia infarction 21.96 12.56 8 26921 356 50577839
Restlessness 21.74 12.56 44 26885 25129 50553066
Palpitations 21.12 12.56 12 26917 94494 50483701
Drug tolerance 21.10 12.56 19 26910 4957 50573238
Hypoxic-ischaemic encephalopathy 21.06 12.56 17 26912 3825 50574370
Ventricular fibrillation 21.01 12.56 27 26902 10532 50567663
Narcotic bowel syndrome 20.85 12.56 6 26923 124 50578071
Loss of consciousness 20.78 12.56 110 26819 104243 50473952
Tachyphylaxis 20.50 12.56 7 26922 257 50577938
Peripheral swelling 20.42 12.56 50 26879 205886 50372309
Fatigue 20.13 12.56 261 26668 707340 49870855
Brain hypoxia 20.04 12.56 8 26921 458 50577737
Inadequate analgesia 19.99 12.56 14 26915 2544 50575651
General physical health deterioration 19.95 12.56 28 26901 142406 50435789
Thyroxine decreased 19.68 12.56 8 26921 480 50577715
Erythema 19.32 12.56 30 26899 146384 50431811
Hepatic enzyme increased 19.25 12.56 27 26902 137353 50440842
Pyrexia 18.73 12.56 122 26807 380081 50198114
Pneumonia aspiration 18.72 12.56 47 26882 30957 50547238
Pulmonary congestion 18.68 12.56 31 26898 15216 50562979
Myoclonus 18.51 12.56 30 26899 14440 50563755
Caesarean section 18.10 12.56 31 26898 15608 50562587
Sudden infant death syndrome 17.96 12.56 6 26923 206 50577989
Hyponatraemia 17.78 12.56 15 26914 96124 50482071
Housebound 17.58 12.56 6 26923 220 50577975
Suicide attempt 17.55 12.56 64 26865 51668 50526527
Catatonia 17.30 12.56 15 26914 3721 50574474
Injection site reaction 17.09 12.56 3 26926 50029 50528166
Seizure 16.88 12.56 114 26815 117760 50460435
Arthritis 16.70 12.56 13 26916 86708 50491487
Drug screen negative 16.54 12.56 6 26923 264 50577931
Brain oedema 16.31 12.56 26 26903 12344 50565851
Anaemia 16.28 12.56 74 26855 252382 50325813
Small intestinal obstruction 16.22 12.56 30 26899 16038 50562157
Retroperitoneal fibrosis 16.06 12.56 6 26923 287 50577908
Secondary adrenocortical insufficiency 15.86 12.56 9 26920 1134 50577061
Dizziness 15.64 12.56 114 26815 346255 50231940
Pain 15.54 12.56 216 26713 578687 49999508
Faeces hard 15.46 12.56 10 26919 1594 50576601
Chest discomfort 15.34 12.56 16 26913 92706 50485489
Ill-defined disorder 15.29 12.56 5 26924 54649 50523546
Respiratory paralysis 15.22 12.56 3 26926 10 50578185
Intestinal perforation 15.17 12.56 23 26906 10456 50567739
Radiation associated pain 15.16 12.56 4 26925 59 50578136
Cardiac failure 15.15 12.56 11 26918 76029 50502166
Mental disorder 15.06 12.56 35 26894 21956 50556239
Accidental exposure to product 15.03 12.56 36 26893 23021 50555174
Hypercapnic coma 14.95 12.56 5 26924 172 50578023
Maternal exposure during breast feeding 14.94 12.56 13 26916 3241 50574954
Accidental poisoning 14.91 12.56 7 26922 595 50577600
Pseudohyperkalaemia 14.80 12.56 3 26926 12 50578183
Pneumoconiosis 14.60 12.56 3 26926 13 50578182
Premature baby 14.60 12.56 31 26898 18306 50559889
Neutropenia 14.60 12.56 36 26893 147929 50430266
Genital herpes simplex 14.45 12.56 5 26924 191 50578004
Wrong product administered 14.45 12.56 16 26913 5344 50572851
Stomatitis 14.11 12.56 20 26909 101324 50476871
Mental impairment 14.10 12.56 24 26905 12020 50566175
Constipation 14.10 12.56 156 26773 185552 50392643
Allodynia 13.98 12.56 7 26922 685 50577510
Irritable bowel syndrome 13.88 12.56 5 26924 51436 50526759
Hepatitis C 13.81 12.56 15 26914 4902 50573293
Alanine aminotransferase increased 13.79 12.56 16 26913 88343 50489852
Ileus 13.73 12.56 25 26904 13204 50564991
Post-traumatic stress disorder 13.64 12.56 14 26915 4289 50573906
Drug level increased 13.56 12.56 31 26898 19237 50558958
Glioblastoma multiforme 13.56 12.56 7 26922 731 50577464
Foetal growth restriction 13.27 12.56 17 26912 6610 50571585
Hypoxia 13.13 12.56 58 26871 51065 50527130
Injection site pain 12.60 12.56 25 26904 110999 50467196

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug abuse 3978.71 14.07 1910 32998 77973 29461646
Toxicity to various agents 2836.23 14.07 2012 32896 171649 29367970
Respiratory depression 754.48 14.07 352 34556 13171 29526448
Respiratory arrest 528.79 14.07 347 34561 25486 29514133
Intentional product misuse 525.23 14.07 387 34521 34274 29505345
Overdose 499.92 14.07 540 34368 79279 29460340
Drug dependence 466.67 14.07 297 34611 20684 29518935
Cardio-respiratory arrest 406.86 14.07 392 34516 50209 29489410
Coma 397.81 14.07 347 34561 39103 29500516
Electrocardiogram QT prolonged 389.01 14.07 330 34578 35807 29503812
Poisoning 381.27 14.07 201 34707 9792 29529827
Death 365.29 14.07 1052 33856 341032 29198587
Completed suicide 309.54 14.07 452 34456 89794 29449825
Miosis 296.73 14.07 158 34750 7851 29531768
Cardiac arrest 291.04 14.07 427 34481 85164 29454455
Torsade de pointes 245.60 14.07 131 34777 6530 29533089
Withdrawal syndrome 225.50 14.07 148 34760 10844 29528775
Drug withdrawal syndrome 215.73 14.07 175 34733 17809 29521810
Drug withdrawal syndrome neonatal 213.05 14.07 96 34812 3299 29536320
Asphyxia 211.48 14.07 110 34798 5205 29534414
Substance abuse 210.29 14.07 119 34789 6668 29532951
Drug interaction 210.22 14.07 608 34300 196777 29342842
Bradypnoea 208.05 14.07 85 34823 2286 29537333
Accidental overdose 179.61 14.07 156 34752 17437 29522182
Pulmonary oedema 157.84 14.07 222 34686 42513 29497106
Unresponsive to stimuli 155.03 14.07 169 34739 24957 29514662
Drug diversion 148.54 14.07 50 34858 765 29538854
Prescription drug used without a prescription 143.27 14.07 55 34853 1249 29538370
Depressed level of consciousness 138.02 14.07 193 34715 36749 29502870
Somnolence 134.92 14.07 324 34584 93631 29445988
Brain oedema 123.98 14.07 108 34800 12112 29527507
Serotonin syndrome 118.98 14.07 124 34784 17388 29522231
Hepatic fibrosis 114.38 14.07 62 34846 3190 29536429
Diarrhoea 113.44 14.07 136 34772 332562 29207057
Exposure via ingestion 101.59 14.07 49 34859 1969 29537650
Myocardial fibrosis 96.13 14.07 39 34869 1029 29538590
Delirium 80.71 14.07 157 34751 39240 29500379
Drug screen positive 77.49 14.07 51 34857 3750 29535869
Victim of child abuse 76.55 14.07 31 34877 814 29538805
Housebound 74.78 14.07 22 34886 210 29539409
Brain injury 73.25 14.07 57 34851 5455 29534164
Pyrexia 71.68 14.07 145 34763 287477 29252142
Compartment syndrome 70.60 14.07 41 34867 2411 29537208
Hyperaesthesia 69.39 14.07 46 34862 3423 29536196
Drug-induced liver injury 62.05 14.07 100 34808 21555 29518064
Neutropenia 60.01 14.07 41 34867 131670 29407949
Cardiopulmonary failure 59.59 14.07 43 34865 3671 29535948
Drug tolerance 59.35 14.07 35 34873 2118 29537501
Pneumonia aspiration 58.42 14.07 132 34776 36605 29503014
Atrial fibrillation 58.08 14.07 26 34882 105620 29433999
Rhabdomyolysis 57.44 14.07 180 34728 60628 29478991
Ventricular tachyarrhythmia 57.15 14.07 19 34889 279 29539340
Laryngomalacia 56.24 14.07 19 34889 294 29539325
Cough 54.40 14.07 42 34866 126685 29412934
Brachial plexopathy 54.00 14.07 13 34895 51 29539568
Pulmonary congestion 52.51 14.07 69 34839 12367 29527252
Febrile neutropenia 52.38 14.07 34 34874 112206 29427413
Foetal exposure during pregnancy 51.98 14.07 120 34788 33747 29505872
Drug use disorder 51.24 14.07 38 34870 3384 29536235
Respiratory acidosis 49.52 14.07 41 34867 4287 29535332
Interstitial lung disease 47.61 14.07 6 34902 57712 29481907
Poisoning deliberate 47.06 14.07 45 34863 5686 29533933
Hepatitis C 46.54 14.07 55 34853 8855 29530764
Postmortem blood drug level abnormal 45.59 14.07 16 34892 279 29539340
General physical health deterioration 45.53 14.07 33 34875 102824 29436795
Accidental exposure to product by child 45.36 14.07 25 34883 1329 29538290
Cardiac failure congestive 45.06 14.07 17 34891 76564 29463055
Intentional overdose 44.95 14.07 123 34785 38405 29501214
Sepsis 43.63 14.07 63 34845 142619 29397000
Sopor 43.61 14.07 59 34849 10875 29528744
Toxicologic test abnormal 43.00 14.07 18 34890 515 29539104
Substance dependence 42.40 14.07 16 34892 346 29539273
Dyspnoea 41.44 14.07 222 34686 326510 29213109
Withdrawal arrhythmia 41.39 14.07 10 34898 40 29539579
Asthenia 41.36 14.07 124 34784 215126 29324493
Visceral congestion 40.46 14.07 17 34891 491 29539128
Agitation 39.67 14.07 142 34766 51162 29488457
Condition aggravated 39.62 14.07 70 34838 146225 29393394
Sedation 38.88 14.07 72 34836 17333 29522286
Cardiac failure 38.38 14.07 23 34885 79264 29460355
Hypoxic-ischaemic encephalopathy 37.78 14.07 35 34873 4249 29535370
Leukoencephalopathy 35.61 14.07 32 34876 3735 29535884
Platelet count decreased 35.26 14.07 43 34865 104629 29434990
Epidural lipomatosis 34.99 14.07 17 34891 694 29538925
Postmortem blood drug level 34.82 14.07 11 34897 136 29539483
Pleural effusion 34.60 14.07 21 34887 71887 29467732
Loss of consciousness 34 14.07 175 34733 73881 29465738
Myocardial infarction 33.40 14.07 49 34859 110247 29429372
Pneumonia 32.53 14.07 233 34675 319939 29219680
Off label use 32.48 14.07 215 34693 300585 29239034
Incorrect route of product administration 32.48 14.07 51 34857 10750 29528869
Hypercapnia 32.01 14.07 30 34878 3696 29535923
Biliary dilatation 31.76 14.07 16 34892 707 29538912
Sudden cardiac death 31.71 14.07 28 34880 3194 29536425
Rash 30.55 14.07 118 34790 189701 29349918
Acute kidney injury 30.47 14.07 186 34722 265081 29274538
Arthralgia 30.09 14.07 76 34832 139541 29400078
Foetal growth restriction 29.84 14.07 29 34879 3737 29535882
Hypercapnic coma 29.12 14.07 10 34898 163 29539456
Ectopic kidney 28.77 14.07 7 34901 29 29539590
Suicide attempt 28.60 14.07 97 34811 34013 29505606
Hyponatraemia 28.26 14.07 23 34885 67610 29472009
Self-medication 28.02 14.07 22 34886 2132 29537487
Brachial plexus injury 27.51 14.07 8 34900 73 29539546
Sudden death 27.38 14.07 55 34853 14055 29525564
Encephalopathy 26.67 14.07 89 34819 30954 29508665
Electrocardiogram QT shortened 26.59 14.07 9 34899 140 29539479
Drug withdrawal maintenance therapy 26.59 14.07 8 34900 83 29539536
Fatigue 26.45 14.07 243 34665 316578 29223041
Child abuse 26.30 14.07 10 34898 221 29539398
IVth nerve disorder 26.16 14.07 6 34902 18 29539601
Renal vein thrombosis 26.08 14.07 9 34899 149 29539470
Renal failure 25.98 14.07 64 34844 118535 29421084
Dizziness 25.60 14.07 126 34782 189558 29350061
Cerebrovascular accident 25.46 14.07 32 34876 76879 29462740
Postoperative ileus 24.75 14.07 13 34895 627 29538992
Juvenile idiopathic arthritis 24.35 14.07 17 34891 1377 29538242
White blood cell count decreased 24.29 14.07 38 34870 83324 29456295
Decreased appetite 24.24 14.07 89 34819 145253 29394366
Haemoglobin decreased 24.11 14.07 58 34850 108317 29431302
Anaemia 24.05 14.07 139 34769 200812 29338807
Thrombocytopenia 22.85 14.07 82 34826 134741 29404878
International normalised ratio increased 22.72 14.07 12 34896 44360 29495259
Coronary artery disease 22.55 14.07 12 34896 44178 29495441
Myoclonus 22.47 14.07 49 34859 13260 29526359
Blood glucose increased 22.31 14.07 22 34886 58962 29480657
Accidental exposure to product 22.18 14.07 43 34865 10710 29528909
Withdrawal hypertension 22.01 14.07 8 34900 155 29539464
Joint swelling 21.84 14.07 16 34892 49614 29490005
Aspartate aminotransferase increased 21.77 14.07 23 34885 59702 29479917
Dysarthria 21.74 14.07 83 34825 30828 29508791
Dependence 21.37 14.07 14 34894 1021 29538598
Haematuria 21.07 14.07 13 34895 44126 29495493
Oedema peripheral 21.05 14.07 58 34850 103499 29436120
Drug detoxification 20.90 14.07 8 34900 180 29539439
Disease progression 20.56 14.07 41 34867 81875 29457744
Central nervous system necrosis 20.33 14.07 7 34901 115 29539504
Prostate cancer 20.22 14.07 3 34905 25524 29514095
Product administered to patient of inappropriate age 20.21 14.07 20 34888 2635 29536984
Mental status changes 19.99 14.07 88 34820 34839 29504780
Dehydration 19.97 14.07 69 34839 114679 29424940
Pruritus 19.84 14.07 71 34837 116778 29422841
Alcohol abuse 19.79 14.07 25 34883 4308 29535311
Myocardial oedema 19.79 14.07 8 34900 209 29539410
Ventricular tachycardia 19.63 14.07 65 34843 22509 29517110
Product prescribing error 19.58 14.07 56 34852 17920 29521699
Respiratory rate decreased 19.34 14.07 17 34891 1928 29537691
Arachnoiditis 19.27 14.07 9 34899 336 29539283
Pneumoconiosis 19.24 14.07 8 34900 225 29539394
Muscle mass 19.21 14.07 8 34900 226 29539393
Asthma 19.10 14.07 8 34900 33841 29505778
Intentional misuse of drug delivery system 18.94 14.07 4 34904 7 29539612
Angioedema 18.90 14.07 7 34901 31908 29507711
Hypersensitivity 18.58 14.07 21 34887 52882 29486737
Blood creatinine increased 18.57 14.07 46 34862 85056 29454563
Mononeuropathy 18.44 14.07 6 34902 82 29539537
Extramedullary haemopoiesis 18.38 14.07 6 34902 83 29539536
Transient ischaemic attack 17.83 14.07 3 34905 23267 29516352
Substance-induced psychotic disorder 17.68 14.07 14 34894 1374 29538245
Sudden infant death syndrome 17.64 14.07 7 34901 174 29539445
Neuropathy peripheral 17.44 14.07 36 34872 70991 29468628
Product dose omission issue 17.42 14.07 57 34851 96326 29443293
Erythema 17.18 14.07 40 34868 75566 29464053
Dyspnoea exertional 17.07 14.07 11 34897 36479 29503140
Renal impairment 16.94 14.07 45 34863 81288 29458331
Cataract 16.90 14.07 3 34905 22375 29517244
Maternal exposure during breast feeding 16.84 14.07 14 34894 1472 29538147
Urticaria 16.81 14.07 24 34884 54636 29484983
Drug tolerance increased 16.76 14.07 9 34899 454 29539165
Colitis 16.67 14.07 8 34900 31240 29508379
Aspiration 16.64 14.07 37 34871 10143 29529476
Musculoskeletal stiffness 16.58 14.07 12 34896 37446 29502173
Myocardial necrosis 16.57 14.07 6 34902 115 29539504
Psychomotor skills impaired 16.57 14.07 18 34890 2643 29536976
Chloasma 16.55 14.07 4 34904 16 29539603
Anaphylactic reaction 16.41 14.07 6 34902 27567 29512052
Cluster headache 16.35 14.07 9 34899 477 29539142
Chronic hepatitis C 16.23 14.07 8 34900 337 29539282
Accidental death 16.20 14.07 16 34892 2102 29537517
Acute myocardial infarction 16.19 14.07 20 34888 48418 29491201
Device toxicity 16.18 14.07 4 34904 18 29539601
Diabetes mellitus 16.07 14.07 14 34894 39817 29499802
Rheumatoid arthritis 16.01 14.07 9 34899 32143 29507476
Anticholinergic syndrome 15.84 14.07 11 34897 883 29538736
Mixed anxiety and depressive disorder 15.83 14.07 4 34904 20 29539599
Elbow synostosis 15.83 14.07 4 34904 20 29539599
Hospitalisation 15.35 14.07 19 34889 45969 29493650
Lethargy 15.32 14.07 86 34822 37494 29502125
Leukopenia 15.29 14.07 26 34882 55177 29484442
Deafness neurosensory 15.29 14.07 17 34891 2561 29537058
Sinusitis 15.21 14.07 11 34897 34339 29505280
Accidental poisoning 15.19 14.07 9 34899 549 29539070
Melaena 15.14 14.07 9 34899 31167 29508452
Gastric bypass 15.05 14.07 7 34901 259 29539360
Hypotension 14.93 14.07 152 34756 194202 29345417
Euphoric mood 14.81 14.07 23 34885 4802 29534817
Substance use disorder 14.75 14.07 7 34901 271 29539348
Perforated ulcer 14.73 14.07 6 34902 160 29539459
Epistaxis 14.65 14.07 24 34884 51680 29487939
Mydriasis 14.64 14.07 26 34882 6059 29533560
Neutrophil count decreased 14.55 14.07 18 34890 43549 29496070
Intentional device misuse 14.52 14.07 6 34902 166 29539453
Blood urine 14.45 14.07 8 34900 429 29539190
Bezoar 14.33 14.07 10 34898 809 29538810
Confusional state 14.27 14.07 221 34687 127656 29411963
Contraindication to medical treatment 14.23 14.07 8 34900 442 29539177
Bladder dilatation 14.15 14.07 12 34896 1296 29538323
COVID-19 14.12 14.07 13 34895 36001 29503618

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug abuse 6616.23 12.47 2864 51440 129510 64314918
Toxicity to various agents 4374.64 12.47 3065 51239 360448 64083980
Respiratory arrest 1261.96 12.47 695 53609 52290 64392138
Respiratory depression 1105.60 12.47 490 53814 22953 64421475
Completed suicide 1097.25 12.47 1135 53169 223279 64221149
Cardio-respiratory arrest 943.10 12.47 729 53575 97664 64346764
Overdose 922.95 12.47 885 53419 158681 64285747
Death 900.36 12.47 1518 52786 481187 63963241
Cardiac arrest 861.70 12.47 839 53465 153225 64291203
Intentional product misuse 763.83 12.47 568 53736 71727 64372701
Drug dependence 618.77 12.47 372 53932 32940 64411488
Poisoning 612.81 12.47 320 53984 21559 64422869
Torsade de pointes 463.58 12.47 246 54058 17117 64427311
Electrocardiogram QT prolonged 423.36 12.47 422 53882 79026 64365402
Coma 415.42 12.47 437 53867 87178 64357250
Drug withdrawal syndrome 375.92 12.47 266 54038 31025 64413403
Miosis 362.74 12.47 191 54113 13075 64431353
Accidental overdose 352.50 12.47 263 54041 33294 64411134
Drug interaction 303.70 12.47 825 53479 361258 64083170
Premature delivery 280.44 12.47 182 54122 18407 64426021
Substance abuse 274.71 12.47 141 54163 9151 64435277
Asphyxia 270.84 12.47 141 54163 9425 64435003
Unresponsive to stimuli 250.59 12.47 258 54046 50135 64394293
Bradypnoea 243.49 12.47 108 54196 5051 64439377
Withdrawal syndrome 215.69 12.47 170 54134 23322 64421106
Congenital nystagmus 209.97 12.47 40 54264 52 64444376
Suicide attempt 207.94 12.47 277 54027 70730 64373698
Exposure via ingestion 194.68 12.47 91 54213 4811 64439617
Depressed level of consciousness 194.34 12.47 288 54016 81148 64363280
Somnolence 185.44 12.47 479 53825 203166 64241262
Pulmonary oedema 170.41 12.47 266 54038 78408 64366020
Hyperaesthesia 168.33 12.47 105 54199 9909 64434519
Drug diversion 160.77 12.47 53 54251 1083 64443345
Intentional overdose 142.99 12.47 265 54039 89679 64354749
Brain oedema 137.69 12.47 128 54176 21947 64422481
Diarrhoea 137.29 12.47 250 54054 722454 63721974
Strabismus congenital 129.83 12.47 24 54280 23 64444405
Drug withdrawal syndrome neonatal 113.83 12.47 29 54275 223 64444205
Maternal exposure during pregnancy 112.45 12.47 249 54055 95635 64348793
Delirium 106.37 12.47 201 54103 68993 64375435
Accidental exposure to product by child 104.49 12.47 48 54256 2437 64441991
Myocardial fibrosis 104.34 12.47 42 54262 1538 64442890
Hepatic fibrosis 102.98 12.47 62 54242 5490 64438938
Serotonin syndrome 102.50 12.47 145 54159 39137 64405291
Drug use disorder 93.07 12.47 60 54244 5994 64438434
Housebound 91.96 12.47 28 54276 437 64443991
Leukoencephalopathy 90.09 12.47 62 54242 6905 64437523
Pneumonia aspiration 87.18 12.47 169 54135 59102 64385326
Victim of child abuse 85.81 12.47 31 54273 840 64443588
Cough 85.66 12.47 77 54227 302071 64142357
Drug screen positive 81.28 12.47 54 54250 5675 64438753
Respiratory acidosis 79.19 12.47 66 54238 9789 64434639
Poisoning deliberate 78.12 12.47 75 54229 13383 64431045
Pyrexia 76.34 12.47 230 54074 558414 63886014
Accidental poisoning 73.69 12.47 32 54272 1421 64443007
Rash 73.02 12.47 175 54129 458374 63986054
Cardiopulmonary failure 73.00 12.47 52 54252 6118 64438310
Pulmonary congestion 72.68 12.47 95 54209 23785 64420643
Rheumatoid arthritis 70.68 12.47 25 54279 164269 64280159
Brain injury 70.42 12.47 62 54242 9903 64434525
Drug abuser 68.84 12.47 49 54255 5759 64438669
Joint swelling 68.38 12.47 49 54255 215333 64229095
Fatigue 68.26 12.47 362 53942 748368 63696060
Atrial fibrillation 67.10 12.47 30 54274 171059 64273369
Arthralgia 65.58 12.47 175 54129 442085 64002343
Agitation 65.51 12.47 193 54111 88174 64356254
Prescription drug used without a prescription 64.22 12.47 35 54269 2565 64441863
Hypersensitivity 60.67 12.47 46 54258 196406 64248022
Compartment syndrome 60.31 12.47 40 54264 4192 64440236
Pruritus 60.01 12.47 107 54197 312293 64132135
Mental status changes 59.83 12.47 148 54156 61014 64383414
General physical health deterioration 59.22 12.47 51 54253 204374 64240054
Neutropenia 58.88 12.47 69 54235 239555 64204873
Ventricular tachycardia 58.26 12.47 104 54200 34161 64410267
Infusion related reaction 58.25 12.47 33 54271 164434 64279994
Hypoxic-ischaemic encephalopathy 57.68 12.47 48 54256 7104 64437324
Sinusitis 56.57 12.47 26 54278 145902 64298526
Nasopharyngitis 55.48 12.47 50 54254 196023 64248405
Visceral congestion 54.80 12.47 22 54282 800 64443628
Drug intolerance 53.12 12.47 48 54256 187944 64256484
Accidental death 52.58 12.47 35 54269 3690 64440738
Foetal exposure during pregnancy 51.30 12.47 37 54267 4439 64439989
Infection 51.30 12.47 48 54256 184832 64259596
Asthenia 50.98 12.47 187 54117 427857 64016571
Dizziness 50.53 12.47 189 54115 429974 64014454
Substance dependence 50.38 12.47 18 54286 472 64443956
Synovitis 50.19 12.47 11 54293 99079 64345349
Abdominal discomfort 49.81 12.47 48 54256 182274 64262154
Drug-induced liver injury 48.41 12.47 117 54187 47526 64396902
Alopecia 48.39 12.47 41 54263 165649 64278779
Dyspnoea 48.31 12.47 381 53923 718293 63726135
Sedation 47.81 12.47 107 54197 41355 64403073
Urticaria 47.42 12.47 33 54271 147284 64297144
Brachial plexopathy 46.87 12.47 13 54291 143 64444285
Hyponatraemia 46.73 12.47 34 54270 148305 64296123
Peripheral swelling 46.43 12.47 65 54239 209088 64235340
Rhabdomyolysis 46.29 12.47 176 54128 91550 64352878
Toxic leukoencephalopathy 45.91 12.47 20 54284 895 64443533
Cardiac failure congestive 45.09 12.47 27 54277 130553 64313875
Systemic lupus erythematosus 45.05 12.47 6 54298 77606 64366822
Drug withdrawal maintenance therapy 44.95 12.47 10 54294 39 64444389
Withdrawal arrhythmia 44.75 12.47 10 54294 40 64444388
Chorea 44.13 12.47 25 54279 1975 64442453
Loss of consciousness 43.74 12.47 243 54061 148122 64296306
Febrile neutropenia 42.98 12.47 57 54247 187600 64256828
Glossodynia 42.80 12.47 3 54301 64693 64379735
Erythema 42.66 12.47 57 54247 187013 64257415
Hypercapnic coma 42.58 12.47 15 54289 377 64444051
Congenital visual acuity reduced 42.17 12.47 8 54296 10 64444418
Hepatitis C 40.20 12.47 48 54256 10967 64433461
Myoclonus 39.86 12.47 74 54230 25044 64419384
Cyanosis 38.63 12.47 68 54236 22087 64422341
Postmortem blood drug level abnormal 38.63 12.47 16 54288 631 64443797
Off label use 38.62 12.47 344 53960 632462 63811966
Pericarditis 38.35 12.47 4 54300 62512 64381916
Cardiac failure 38.34 12.47 33 54271 132340 64312088
Sudden death 38.09 12.47 64 54240 20032 64424396
Alcohol abuse 37.96 12.47 32 54272 4820 64439608
Toxicologic test abnormal 37.39 12.47 19 54285 1206 64443222
Anaemia 37.26 12.47 178 54126 378502 64065926
Epidural lipomatosis 37.06 12.47 17 54287 860 64443568
Interstitial lung disease 36.97 12.47 18 54286 97714 64346714
Arthropathy 36.47 12.47 29 54275 120938 64323490
Swelling 36.34 12.47 49 54255 160169 64284259
Encephalopathy 35.78 12.47 120 54184 58699 64385729
Hepatic enzyme increased 35.72 12.47 34 54270 129909 64314519
Hypercapnia 35.72 12.47 38 54266 7656 64436772
Therapeutic product effect decreased 35.60 12.47 27 54277 115324 64329104
Postoperative ileus 35.24 12.47 17 54287 964 64443464
Developmental delay 34.35 12.47 17 54287 1020 64443408
Sepsis 34.18 12.47 91 54213 230250 64214178
Treatment failure 33.98 12.47 29 54275 116787 64327641
Contraindicated product administered 33.59 12.47 25 54279 107804 64336624
Sopor 33.58 12.47 76 54228 29585 64414843
Pneumoconiosis 32.82 12.47 11 54293 237 64444191
Condition aggravated 32.72 12.47 182 54122 372244 64072184
Long QT syndrome 32.42 12.47 30 54274 5109 64439319
Contusion 32.29 12.47 29 54275 113936 64330492
Substance use disorder 32.22 12.47 12 54292 355 64444073
Postmortem blood drug level 32.06 12.47 11 54293 255 64444173
Drug tolerance 31.75 12.47 32 54272 6053 64438375
Myocardial infarction 30.72 12.47 58 54246 165763 64278665
Discomfort 30.43 12.47 15 54289 80863 64363565
Child abuse 30.07 12.47 10 54294 210 64444218
Drug ineffective 29.93 12.47 513 53791 839734 63604694
Arthritis 29.40 12.47 17 54287 83797 64360631
Sudden cardiac death 29.37 12.47 27 54277 4560 64439868
Pain in extremity 28.33 12.47 145 54159 302940 64141488
Suspected counterfeit product 28.30 12.47 12 54292 502 64443926
Pain 28.26 12.47 314 53990 553197 63891231
IVth nerve disorder 28.18 12.47 6 54298 18 64444410
Central nervous system necrosis 27.57 12.47 10 54294 274 64444154
Stomatitis 27.50 12.47 31 54273 109574 64334854
Injection site pain 27.42 12.47 32 54272 111376 64333052
Platelet count decreased 27.41 12.47 63 54241 167648 64276780
Product dose omission issue 27.35 12.47 79 54225 194668 64249760
Brachial plexus injury 27.28 12.47 8 54296 109 64444319
Post-anoxic myoclonus 26.85 12.47 6 54298 24 64444404
Decreased appetite 26.61 12.47 134 54170 281155 64163273
Ill-defined disorder 26.56 12.47 3 54301 44049 64400379
Electrocardiogram QT shortened 26.22 12.47 9 54295 209 64444219
Chest pain 26.17 12.47 106 54198 235874 64208554
Injection site reaction 26.16 12.47 4 54300 46660 64397768
Acute kidney injury 26.14 12.47 247 54057 448993 63995435
Drug tolerance increased 26.13 12.47 12 54292 609 64443819
Incoherent 25.94 12.47 31 54273 7087 64437341
Pleural effusion 25.49 12.47 42 54262 126517 64317911
Aggression 25.23 12.47 91 54213 46141 64398287
Gastrointestinal disorder 25.21 12.47 23 54281 89686 64354742
Urinary tract infection 25.07 12.47 105 54199 231491 64212937
Restlessness 24.93 12.47 82 54222 39703 64404725
Asthma 24.92 12.47 26 54278 95199 64349229
Aspartate aminotransferase increased 24.84 12.47 39 54265 119749 64324679
Affective disorder 24.55 12.47 29 54275 6551 64437877
Incorrect route of product administration 24.51 12.47 58 54246 23240 64421188
Optic nerve hypoplasia 24.30 12.47 5 54299 12 64444416
Lethargy 24.18 12.47 123 54181 72471 64371957
Respiratory rate decreased 24.14 12.47 24 54280 4467 64439961
Productive cough 24.07 12.47 16 54288 73187 64371241
Anaphylactic reaction 23.98 12.47 14 54290 68650 64375778
Angioedema 23.97 12.47 11 54293 61810 64382618
Stress cardiomyopathy 23.88 12.47 34 54270 9223 64435205
Chest discomfort 23.88 12.47 38 54266 116068 64328360
Self-medication 23.86 12.47 23 54281 4122 64440306
Exposure via breast milk 23.32 12.47 12 54292 782 64443646
Haemoglobin decreased 23.31 12.47 85 54219 194978 64249450
Crying 22.21 12.47 51 54253 20039 64424389
Alanine aminotransferase increased 22.10 12.47 53 54251 138978 64305450
Chills 22.08 12.47 52 54252 137212 64307216
Palpitations 21.68 12.47 34 54270 104454 64339974
Impaired healing 21.59 12.47 12 54292 60461 64383967
Intentional misuse of drug delivery system 21.55 12.47 4 54300 4 64444424
Herpes zoster 21.43 12.47 21 54283 79166 64365262
Irritable bowel syndrome 21.42 12.47 3 54301 37366 64407062
Chronic hepatitis C 21.31 12.47 10 54294 533 64443895
Drug detoxification 21.19 12.47 8 54296 246 64444182
Oedema peripheral 21.16 12.47 98 54206 210219 64234209
Basal ganglia infarction 21.12 12.47 10 54294 544 64443884
Hyperreflexia 21.07 12.47 28 54276 7120 64437308
Wound 21.02 12.47 20 54284 76457 64367971
Cerebral vasoconstriction 21.01 12.47 13 54291 1209 64443219
Thrombocytopenia 20.94 12.47 107 54197 223694 64220734
Inadequate analgesia 20.90 12.47 21 54283 3957 64440471
Accidental exposure to product 20.89 12.47 59 54245 26305 64418123
Diabetic hyperglycaemic coma 20.72 12.47 6 54298 78 64444350
Cerebrovascular accident 20.66 12.47 54 54250 137529 64306899
Drug eruption 20.48 12.47 3 54301 36133 64408295
Cardio-respiratory distress 20.46 12.47 8 54296 271 64444157
Allodynia 20.42 12.47 13 54291 1270 64443158
COVID-19 20.41 12.47 15 54289 65125 64379303
Sudden infant death syndrome 20.33 12.47 7 54297 164 64444264
International normalised ratio increased 20.29 12.47 22 54282 79145 64365283
Cataract 20.06 12.47 9 54295 51253 64393175
Confusional state 20.06 12.47 320 53984 260824 64183604
Aspiration 19.94 12.47 44 54260 16841 64427587
Fall 19.86 12.47 240 54064 416586 64027842
Substance use 19.75 12.47 10 54294 630 64443798
Malaise 19.71 12.47 226 54078 396021 64048407
Rash pruritic 19.63 12.47 12 54292 57392 64387036
Musculoskeletal stiffness 19.55 12.47 47 54257 123159 64321269
Headache 19.51 12.47 321 53983 529146 63915282
Wrong product administered 19.40 12.47 28 54276 7692 64436736
White blood cell count decreased 19.37 12.47 68 54236 157769 64286659
Nausea 19.35 12.47 509 53795 785291 63659137
Duodenal ulcer perforation 19.34 12.47 3 54301 34622 64409806
Osteoarthritis 19.31 12.47 15 54289 63321 64381107
Withdrawal hypertension 19.23 12.47 8 54296 319 64444109
Substance-induced psychotic disorder 19.18 12.47 17 54287 2738 64441690
Leukopenia 19.11 12.47 35 54269 101207 64343221
Testicular atrophy 18.88 12.47 8 54296 334 64444094
Myocardial oedema 18.84 12.47 8 54296 336 64444092
Neurological examination abnormal 18.71 12.47 9 54295 507 64443921
Injection site bruising 18.49 12.47 4 54300 36369 64408059
Epistaxis 18.45 12.47 34 54270 98097 64346331
Drug level increased 18.40 12.47 67 54237 34129 64410299
Musculoskeletal pain 18.28 12.47 25 54279 81269 64363159
Injection site swelling 18.27 12.47 6 54298 41347 64403081
Biliary dilatation 17.83 12.47 15 54289 2253 64442175
Injection site erythema 17.78 12.47 20 54284 70780 64373648
Suicidal ideation 17.64 12.47 106 54198 66436 64377992
Mucosal inflammation 17.63 12.47 16 54288 62568 64381860
Device toxicity 17.52 12.47 4 54300 18 64444410
Muscle mass 17.44 12.47 8 54296 405 64444023
Dehydration 17.37 12.47 109 54195 216654 64227774
Gastrooesophageal reflux disease 17.30 12.47 27 54277 83116 64361312
Dyspnoea exertional 17.27 12.47 22 54282 73708 64370720
Brain hypoxia 17.12 12.47 10 54294 837 64443591
Cluster headache 17.06 12.47 10 54294 843 64443585
Toxic encephalopathy 16.95 12.47 30 54274 9785 64434643
Pupil fixed 16.87 12.47 17 54287 3215 64441213
Haematoma 16.77 12.47 9 54295 46241 64398187
Diabetes mellitus 16.45 12.47 19 54285 66455 64377973
Pulmonary haemorrhage 16.44 12.47 35 54269 13074 64431354
Bone marrow failure 16.43 12.47 10 54294 47942 64396486
Blood pressure increased 16.42 12.47 82 54222 172470 64271958
Hypoaesthesia 16.36 12.47 61 54243 139047 64305381
Renal failure 16.35 12.47 88 54216 181600 64262828
Myocardial necrosis 16.35 12.47 7 54297 300 64444128
Psoriatic arthropathy 16.32 12.47 8 54296 43273 64401155
Arachnoiditis 16.26 12.47 9 54295 680 64443748
Microcephaly 16.16 12.47 6 54298 176 64444252
Neutrophil count decreased 16.12 12.47 25 54279 77171 64367257
Psychomotor skills impaired 16.12 12.47 18 54286 3827 64440601
Disease progression 16.10 12.47 63 54241 141617 64302811
Fluid retention 15.91 12.47 16 54288 59590 64384838
Rash maculo-papular 15.84 12.47 10 54294 47016 64397412
Hepatotoxicity 15.66 12.47 7 54297 39955 64404473
Lung disorder 15.41 12.47 17 54287 60683 64383745
Mononeuropathy 15.35 12.47 6 54298 203 64444225
Blister 15.27 12.47 28 54276 80939 64363489
Coronary artery disease 15.26 12.47 17 54287 60416 64384012
Euphoric mood 15.25 12.47 23 54281 6568 64437860
Blood pressure decreased 15.22 12.47 31 54273 86168 64358260
Abdominal pain upper 15.08 12.47 86 54218 174944 64269484
Diffuse alveolar damage 15.06 12.47 16 54288 3219 64441209
Chloasma 15.05 12.47 4 54300 37 64444391
Blood pressure fluctuation 14.93 12.47 13 54291 51858 64392570
Mydriasis 14.91 12.47 37 54267 15275 64429153
Potentiating drug interaction 14.87 12.47 25 54279 7827 64436601
Product prescribing error 14.85 12.47 64 54240 35205 64409223
Blood pressure systolic increased 14.72 12.47 12 54292 49441 64394987
Bronchitis 14.61 12.47 45 54259 108698 64335730
Hyperglycaemia 14.48 12.47 18 54286 60950 64383478
Cystitis 14.48 12.47 9 54295 42666 64401762
Pneumonia 14.39 12.47 360 53944 559216 63885212
Paranoia 14.35 12.47 38 54266 16314 64428114
Blood glucose increased 14.34 12.47 39 54265 98034 64346394
Juvenile idiopathic arthritis 14.31 12.47 17 54287 3862 64440566
Colitis 14.28 12.47 17 54287 58657 64385771
Blood lactate dehydrogenase increased 14.27 12.47 5 54299 33073 64411355
Brain death 14.26 12.47 19 54285 4842 64439586
Injection site pruritus 14.25 12.47 7 54297 37819 64406609
Rash erythematous 14.23 12.47 12 54292 48621 64395807
Neuropathy peripheral 14.17 12.47 51 54253 117474 64326954
Thyroxine decreased 14.17 12.47 8 54296 628 64443800
Dysarthria 14.10 12.47 92 54212 59314 64385114
Oral tuberculosis 14.09 12.47 3 54301 9 64444419
Multi-organ disorder 14.02 12.47 13 54291 2220 64442208
Congestive hepatopathy 13.98 12.47 17 54287 3956 64440472
Blood cholesterol increased 13.87 12.47 13 54291 50053 64394375
Breakthrough pain 13.79 12.47 10 54294 1210 64443218
Pulse absent 13.75 12.47 26 54278 8920 64435508
Knee arthroplasty 13.66 12.47 3 54301 26996 64417432
Myalgia 13.63 12.47 78 54226 158539 64285889
Melaena 13.59 12.47 15 54289 53533 64390895
Secondary adrenocortical insufficiency 13.48 12.47 13 54291 2332 64442096
Hypopnoea 13.47 12.47 15 54289 3179 64441249
Abdominal distension 13.42 12.47 39 54265 95955 64348473
Haematochezia 13.38 12.47 22 54282 66351 64378077
Lipid metabolism disorder 13.32 12.47 6 54298 291 64444137
Respiratory failure 13.31 12.47 200 54104 160983 64283445
Flushing 13.29 12.47 29 54275 78619 64365809
Lymphocyte count decreased 13.24 12.47 9 54295 40690 64403738
Hypertension 13.21 12.47 147 54157 259114 64185314
Haematuria 13.19 12.47 19 54285 60452 64383976
Pancytopenia 13.12 12.47 69 54235 143240 64301188
Gastrointestinal haemorrhage 13.09 12.47 62 54242 132250 64312178
Cardiac death 13.03 12.47 10 54294 1318 64443110
Eosinophilia 12.96 12.47 8 54296 38068 64406360
C-reactive protein increased 12.95 12.47 39 54265 94870 64349558
Weight increased 12.94 12.47 116 54188 213232 64231196
Lower respiratory tract infection 12.82 12.47 39 54265 94575 64349853
Blood urine 12.74 12.47 8 54296 763 64443665
Victim of homicide 12.72 12.47 5 54299 172 64444256
Emphysema 12.66 12.47 33 54271 14036 64430392
Faeces hard 12.64 12.47 12 54292 2110 64442318
Left ventricular hypertrophy 12.64 12.47 26 54278 9480 64434948
Hypoventilation 12.56 12.47 20 54284 5986 64438442
Subdural haematoma 12.52 12.47 4 54300 28050 64416378

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 withdrawal syndrome neonatal 1014.75 89.76 506 833 1547 81792
Foetal exposure during pregnancy 160.75 89.76 437 902 10974 72365

Pharmacologic Action:

SourceCodeDescription
ATC N02AC52 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Diphenylpropylamine derivatives
ATC N07BC02 NERVOUS SYSTEM
OTHER NERVOUS SYSTEM DRUGS
DRUGS USED IN ADDICTIVE DISORDERS
Drugs used in opioid dependence
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
MeSH PA D000996 Antitussive Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009294 Narcotics
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D019141 Respiratory System Agents
MeSH PA D018689 Sensory System Agents
CHEBI has role CHEBI:35482 narcotic analgesic
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:50949 SSRI
CHEBI has role CHEBI:55322 mu-opioid agonists
CHEBI has role CHEBI:60643 N-methyl-D-aspartate receptor antagonists
CHEBI has role CHEBI:78298 environmental contaminants
FDA MoA N0000175684 Full Opioid Agonists
FDA EPC N0000175690 Opioid Agonist

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

DiseaseRelationSNOMED_IDDOID
Severe pain indication 76948002
Opioid withdrawal indication 87132004
Chronic disease of respiratory system contraindication 17097001
Mood swings contraindication 18963009
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Hypercapnia contraindication 29596007
Torsades de pointes contraindication 31722008
Disorder of gallbladder contraindication 39621005 DOID:0060262
Hypothyroidism contraindication 40930008 DOID:1459
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Bradycardia contraindication 48867003
Paralytic ileus contraindication 55525008 DOID:8442
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Urethral stricture contraindication 76618002
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Epilepsy contraindication 84757009 DOID:1826
Kidney disease contraindication 90708001 DOID:557
Prolonged QT interval contraindication 111975006
Acute abdominal pain contraindication 116290004
Procedure on urinary system contraindication 118677009
Disease of liver contraindication 235856003 DOID:409
Benign prostatic hyperplasia contraindication 266569009
Pseudomembranous enterocolitis contraindication 397683000
Congenital long QT syndrome contraindication 442917000
Acute exacerbation of asthma contraindication 708038006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.55 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
Mu-type opioid receptor GPCR AGONIST Ki 8.78 WOMBAT-PK CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.01 CHEMBL
Kappa-type opioid receptor GPCR IC50 6.29 CHEMBL
Glutamate receptor ionotropic, NMDA 3A Ion channel WOMBAT-PK
Neuronal acetylcholine receptor subunit alpha-10 Ion channel WOMBAT-PK
Delta-type opioid receptor GPCR IC50 5.96 CHEMBL
Opioid receptor GPCR IC50 7.29 CHEMBL

External reference:

IDSource
4019820 VUID
N0000147909 NUI
D02102 KEGG_DRUG
1095-90-5 SECONDARY_CAS_RN
4017431 VANDF
4019820 VANDF
C0025605 UMLSCUI
CHEBI:6807 CHEBI
CHEMBL651 ChEMBL_ID
DB00333 DRUGBANK_ID
CHEMBL1200825 ChEMBL_ID
D008691 MESH_DESCRIPTOR_UI
4095 PUBCHEM_CID
5458 IUPHAR_LIGAND_ID
788 INN_ID
UC6VBE7V1Z UNII
218337 RXNORM
1981 MMSL
5065 MMSL
d00050 MMSL
001566 NDDF
004628 NDDF
23883005 SNOMEDCT_US
387286002 SNOMEDCT_US
51758009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Methadone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-0391 CONCENTRATE 10 mg ORAL ANDA 39 sections
Methadone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-0391 CONCENTRATE 10 mg ORAL ANDA 39 sections
Methadone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-0392 CONCENTRATE 10 mg ORAL ANDA 39 sections
Methadone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-0392 CONCENTRATE 10 mg ORAL ANDA 39 sections
METHADONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0054-0709 TABLET 5 mg ORAL ANDA 32 sections
METHADONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0054-0710 TABLET 10 mg ORAL ANDA 32 sections
Methadone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-3553 CONCENTRATE 10 mg ORAL ANDA 31 sections
Methadone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-3555 SOLUTION 5 mg ORAL ANDA 30 sections
Methadone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-3556 SOLUTION 10 mg ORAL ANDA 30 sections
DOLOPHINE HUMAN PRESCRIPTION DRUG LABEL 1 0054-4218 TABLET 5 mg ORAL NDA 32 sections
DOLOPHINE HUMAN PRESCRIPTION DRUG LABEL 1 0054-4219 TABLET 10 mg ORAL NDA 32 sections
DISKETS HUMAN PRESCRIPTION DRUG LABEL 1 0054-4538 TABLET 40 mg ORAL NDA 31 sections
METHADONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0054-4570 TABLET 5 mg ORAL NDA 32 sections
METHADONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0054-4571 TABLET 10 mg ORAL NDA 32 sections
METHADONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0054-8553 TABLET 5 mg ORAL NDA 32 sections
METHADONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0054-8554 TABLET 10 mg ORAL NDA 32 sections
METHADOSE HUMAN PRESCRIPTION DRUG LABEL 1 0406-0527 CONCENTRATE 10 mg ORAL NDA 33 sections
METHADOSE DISPERSIBLE HUMAN PRESCRIPTION DRUG LABEL 1 0406-0540 TABLET 40 mg ORAL ANDA 34 sections
METHADOSE DISPERSIBLE HUMAN PRESCRIPTION DRUG LABEL 1 0406-0540 TABLET 40 mg ORAL ANDA 34 sections
METHADONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0406-2540 TABLET 40 mg ORAL ANDA 34 sections
METHADONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0406-2540 TABLET 40 mg ORAL ANDA 34 sections
Methadone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0406-4123 CONCENTRATE 10 mg ORAL ANDA 40 sections
Methadone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0406-4123 CONCENTRATE 10 mg ORAL ANDA 40 sections
METHADONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0406-5755 TABLET 5 mg ORAL ANDA 34 sections
METHADONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0406-5771 TABLET 10 mg ORAL ANDA 34 sections
METHADONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0406-6221 SOLUTION 10 mg ORAL ANDA 35 sections
METHADONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0406-6225 SOLUTION 5 mg ORAL ANDA 35 sections
METHADOSESUGAR-FREE HUMAN PRESCRIPTION DRUG LABEL 1 0406-8725 CONCENTRATE 10 mg ORAL NDA 33 sections
Methadone Hydrocloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1926 CONCENTRATE 10 mg ORAL ANDA 28 sections
Methadone Hydrocloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1926 CONCENTRATE 10 mg ORAL ANDA 28 sections