methadone ๐Ÿถ 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 ยตM/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 2783.06 13.01 1106 29093 71412 63387411
Toxicity to various agents 1962.32 13.01 1299 28900 245951 63212872
Exposure during pregnancy 667.78 13.01 568 29631 154979 63303844
Completed suicide 635.55 13.01 537 29662 145136 63313687
Death 522.19 13.01 757 29442 373624 63085199
Cardio-respiratory arrest 503.12 13.01 328 29871 59631 63399192
Respiratory arrest 469.53 13.01 253 29946 32392 63426431
Respiratory depression 437.52 13.01 184 30015 13531 63445292
Cardiac arrest 370.07 13.01 325 29874 92220 63366603
Premature delivery 335.88 13.01 198 30001 30083 63428740
Drug withdrawal syndrome 299.45 13.01 177 30022 27017 63431806
Torsade de pointes 290.42 13.01 137 30062 13214 63445609
Overdose 274.70 13.01 305 29894 114773 63344050
Intentional product misuse 269.91 13.01 227 29972 60690 63398133
Premature labour 258.80 13.01 124 30075 12380 63446443
Poisoning 253.96 13.01 126 30073 13574 63445249
Drug dependence 222.55 13.01 141 30058 24342 63434481
Depressed level of consciousness 177.09 13.01 181 30018 61897 63396926
Drug interaction 168.30 13.01 350 29849 228781 63230042
Accidental overdose 167.62 13.01 116 30083 23193 63435630
Electrocardiogram QT prolonged 166.96 13.01 172 30027 59358 63399465
Drug withdrawal syndrome neonatal 159.00 13.01 53 30146 2028 63456795
Withdrawal syndrome 152.02 13.01 103 30096 19894 63438929
Unresponsive to stimuli 131.42 13.01 117 30082 33699 63425124
Drug diversion 122.15 13.01 36 30163 912 63457911
Hyperaesthesia 119.19 13.01 67 30132 9291 63449532
Miosis 108.43 13.01 58 30141 7295 63451528
Maternal exposure during pregnancy 103.67 13.01 283 29916 219779 63239044
Exposure via ingestion 102.75 13.01 42 30157 2867 63455956
Coma 94.62 13.01 134 30065 64230 63394593
Somnolence 91.42 13.01 237 29962 178448 63280375
Delirium 84.51 13.01 112 30087 50429 63408394
Substance abuse 82.56 13.01 42 30157 4765 63454058
Toxic leukoencephalopathy 81.57 13.01 25 30174 726 63458097
Asphyxia 80.74 13.01 45 30154 6136 63452687
Accidental exposure to product by child 77.86 13.01 27 30172 1166 63457657
Bradypnoea 72.81 13.01 35 30164 3515 63455308
Systemic lupus erythematosus 71.36 13.01 8 30191 208910 63249913
Glossodynia 68.96 13.01 4 30195 178872 63279951
Rash 64.31 13.01 105 30094 560766 62898057
Hand deformity 63.25 13.01 3 30196 159454 63299369
Abdominal discomfort 62.01 13.01 38 30161 320847 63137976
Catatonia 59.59 13.01 33 30166 4444 63454379
Alopecia 56.03 13.01 47 30152 337489 63121334
Arthropathy 55.72 13.01 21 30178 234771 63224052
Drug intolerance 53.70 13.01 41 30158 308620 63150203
Foetal exposure during pregnancy 53.68 13.01 71 30128 31891 63426932
Mental status changes 53.16 13.01 79 30120 39520 63419303
Synovitis 52.98 13.01 12 30187 186906 63271917
Chorea 52.46 13.01 22 30177 1602 63457221
Leukoencephalopathy 51.90 13.01 30 30169 4383 63454440
Infusion related reaction 51.86 13.01 26 30173 245495 63213328
Sedation 51.49 13.01 77 30122 38732 63420091
Rheumatoid arthritis 50.51 13.01 29 30170 253790 63205033
Affective disorder 47.51 13.01 32 30167 6114 63452709
Hypoxic-ischaemic encephalopathy 47.40 13.01 28 30171 4259 63454564
Wound 47.24 13.01 10 30189 163253 63295570
Discomfort 46.92 13.01 11 30188 167363 63291460
Accidental death 45.18 13.01 21 30178 1955 63456868
Joint swelling 44.79 13.01 54 30145 327612 63131211
Swelling 43.68 13.01 40 30159 275338 63183485
Drug use disorder 43.51 13.01 28 30171 4956 63453867
Contraindicated product administered 41.70 13.01 26 30173 217622 63241201
Drug screen positive 40.91 13.01 24 30175 3605 63455218
Long QT syndrome 40.46 13.01 23 30176 3256 63455567
Respiratory acidosis 40.40 13.01 30 30169 6685 63452138
Hypersensitivity 40.24 13.01 48 30151 292637 63166186
Ventricular tachycardia 39.27 13.01 48 30151 19931 63438892
Infection 39.13 13.01 31 30168 229142 63229681
Therapeutic product effect decreased 38.52 13.01 22 30177 193165 63265658
Sinusitis 38.27 13.01 31 30168 226622 63232201
Suspected counterfeit product 38.19 13.01 12 30187 379 63458444
Poisoning deliberate 38.08 13.01 36 30163 11182 63447641
Nasopharyngitis 37.91 13.01 39 30160 254218 63204605
Agitation 36.59 13.01 85 30114 59672 63399151
Prescription drug used without a prescription 35.68 13.01 19 30180 2367 63456456
Exposure via breast milk 35.40 13.01 18 30181 2039 63456784
Cough 35.17 13.01 53 30146 292690 63166133
Pruritus 34.87 13.01 75 30124 361378 63097445
Contusion 34.62 13.01 14 30185 150030 63308793
Narcotic bowel syndrome 34.43 13.01 9 30190 144 63458679
Diarrhoea 33.78 13.01 201 29998 715165 62743658
Cyanosis 32.17 13.01 40 30159 16895 63441928
Suicidal ideation 32.06 13.01 83 30116 62338 63396485
Urticaria 31.48 13.01 20 30179 165782 63293041
Drug ineffective 31.09 13.01 333 29866 1044432 62414391
General physical health deterioration 31.04 13.01 30 30169 201372 63257451
Arthralgia 30.76 13.01 153 30046 569557 62889266
Hepatic enzyme increased 30.19 13.01 31 30168 202297 63256526
Atrial fibrillation 30.15 13.01 9 30190 116627 63342196
Intentional overdose 29.63 13.01 90 30109 74062 63384761
Congenital nystagmus 29.32 13.01 5 30194 6 63458817
Cardio-respiratory distress 29.22 13.01 8 30191 154 63458669
Neurological examination abnormal 28.74 13.01 9 30190 281 63458542
Seizure 28.62 13.01 132 30067 132502 63326321
Thyroxine decreased 28.55 13.01 11 30188 642 63458181
Low birth weight baby 28.34 13.01 25 30174 7104 63451719
Cerebral vasoconstriction 28.13 13.01 13 30186 1195 63457628
Lower respiratory tract infection 27.93 13.01 14 30185 132293 63326530
Gastrointestinal disorder 27.54 13.01 14 30185 131225 63327598
Treatment failure 26.96 13.01 33 30166 199010 63259813
Stress cardiomyopathy 25.91 13.01 27 30172 9423 63449400
Emotional distress 25.30 13.01 51 30148 32498 63426325
Crying 25.00 13.01 42 30157 23301 63435522
Myoclonus 24.73 13.01 34 30165 15834 63442989
Post-anoxic myoclonus 24.48 13.01 5 30194 24 63458799
Pyrexia 24.43 13.01 128 30071 470350 62988473
Pulmonary oedema 24.21 13.01 69 30130 54804 63404019
Irritable bowel syndrome 23.92 13.01 5 30194 82407 63376416
Psoriatic arthropathy 23.76 13.01 7 30192 91513 63367310
Palpitations 23.70 13.01 12 30187 112758 63346065
Substance use 23.48 13.01 9 30190 518 63458305
Visceral congestion 23.37 13.01 8 30191 332 63458491
Pneumonia aspiration 23.22 13.01 51 30148 34489 63424334
Substance use disorder 22.95 13.01 7 30192 200 63458623
Restlessness 22.72 13.01 46 30153 29407 63429416
Fatigue 22.51 13.01 293 29906 887735 62571088
Ventricular fibrillation 22.50 13.01 28 30171 11839 63446984
Dizziness 22.29 13.01 117 30082 429808 63029015
Basal ganglia infarction 22.22 13.01 8 30191 386 63458437
Hepatitis C 21.98 13.01 19 30180 5255 63453568
Ill-defined disorder 21.69 13.01 6 30193 81749 63377074
Loss of consciousness 21.50 13.01 112 30087 118009 63340814
Cardiopulmonary failure 21.42 13.01 16 30183 3596 63455227
Peripheral swelling 21.08 13.01 61 30138 265881 63192942
Stomatitis 20.98 13.01 21 30178 138704 63320119
Tachyphylaxis 20.97 13.01 7 30192 269 63458554
Erythema 20.91 13.01 32 30167 175719 63283104
Ileus 20.65 13.01 30 30169 14695 63444128
Immune thrombocytopenia 20.16 13.01 25 30174 10531 63448292
Brain hypoxia 19.68 13.01 8 30191 538 63458285
Foetal growth restriction 19.68 13.01 21 30178 7532 63451291
Allodynia 19.65 13.01 9 30190 810 63458013
Small intestinal obstruction 19.64 13.01 33 30166 18304 63440519
Inadequate analgesia 19.64 13.01 14 30185 2929 63455894
Hyperinsulinaemic hypoglycaemia 19.56 13.01 5 30194 73 63458750
Intestinal perforation 19.20 13.01 26 30173 11937 63446886
Constipation 19.17 13.01 177 30022 224766 63234057
Maternal exposure during breast feeding 19.15 13.01 16 30183 4225 63454598
Pain 18.87 13.01 244 29955 740384 62718439
Osteoarthritis 18.79 13.01 11 30188 95332 63363491
Caesarean section 18.71 13.01 31 30168 17001 63441822
Radiation associated pain 18.23 13.01 5 30194 97 63458726
Pulmonary congestion 18.20 13.01 31 30168 17387 63441436
Suicide attempt 18.16 13.01 67 30132 60851 63397972
Arthritis 18.16 13.01 17 30182 115904 63342919
Drug level increased 18.12 13.01 36 30163 22700 63436123
Housebound 18.04 13.01 6 30193 228 63458595
Hyponatraemia 18.02 13.01 16 30183 111884 63346939
Drug tolerance 17.54 13.01 19 30180 6930 63451893
Chest discomfort 17.38 13.01 16 30183 109953 63348870
Brain oedema 17.18 13.01 27 30172 14168 63444655
Blood cholesterol increased 16.96 13.01 12 30187 94020 63364803
Liver injury 16.90 13.01 4 30195 60516 63398307
Anaemia 16.84 13.01 77 30122 293353 63165470
Colitis ischaemic 16.77 13.01 23 30176 10685 63448138
Drug screen negative 16.66 13.01 6 30193 290 63458533
Genital herpes simplex 16.56 13.01 6 30193 295 63458528
Retroperitoneal fibrosis 16.40 13.01 6 30193 303 63458520
Sudden infant death syndrome 16.40 13.01 6 30193 303 63458520
Impaired healing 16.11 13.01 15 30184 102527 63356296
Brachial artery entrapment syndrome 15.54 13.01 4 30195 60 63458763
Accidental poisoning 15.38 13.01 7 30192 621 63458202
Alanine aminotransferase increased 15.35 13.01 16 30183 103754 63355069
Pseudohyperkalaemia 15.13 13.01 3 30196 12 63458811
Blister 15.09 13.01 24 30175 129790 63329033
COVID-19 15.04 13.01 19 30180 113084 63345739
Aggression 15.01 13.01 34 30165 23464 63435359
Secondary adrenocortical insufficiency 14.94 13.01 9 30190 1419 63457404
Hypercapnic coma 14.93 13.01 5 30194 194 63458629
Mental disorder 14.92 13.01 36 30163 25883 63432940
Hypoglycaemia 14.62 13.01 62 30137 60003 63398820
Hyperreflexia 14.59 13.01 16 30183 5918 63452905
Abdominal pain upper 14.49 13.01 50 30149 206394 63252429
Respiratory paralysis 14.42 13.01 3 30196 16 63458807
Premature baby 14.37 13.01 31 30168 20704 63438119
Septic pulmonary embolism 14.28 13.01 4 30195 84 63458739
Injection site reaction 14.26 13.01 5 30194 58519 63400304
Wrong product administered 14.13 13.01 16 30183 6125 63452698
Faeces hard 13.80 13.01 10 30189 2147 63456676
Glioblastoma multiforme 13.74 13.01 7 30192 796 63458027
Angioedema 13.74 13.01 3 30196 47962 63410861
Accidental exposure to product 13.62 13.01 36 30163 27369 63431454
Respiratory failure 13.60 13.01 89 30110 101769 63357054
Hallucination, visual 13.55 13.01 29 30170 19269 63439554
Posterior reversible encephalopathy syndrome 13.27 13.01 27 30172 17318 63441505
Mental impairment 13.25 13.01 24 30175 14127 63444696
Pancreatectomy 13.16 13.01 3 30196 26 63458797
Type 2 diabetes mellitus 13.11 13.01 7 30192 63861 63394962
Asthenia 13.10 13.01 118 30081 383486 63075337

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 4608.03 13.99 2225 37053 96871 34820782
Toxicity to various agents 3376.48 13.99 2321 36957 198041 34719612
Respiratory depression 1006.42 13.99 448 38830 15797 34901856
Intentional product misuse 640.67 13.99 477 38801 45134 34872519
Respiratory arrest 566.96 13.99 367 38911 27676 34889977
Drug dependence 562.33 13.99 346 38932 23871 34893782
Overdose 522.81 13.99 575 38703 90484 34827169
Coma 518.05 13.99 421 38857 45257 34872396
Poisoning 498.53 13.99 253 39025 11973 34905680
Miosis 447.08 13.99 217 39061 9318 34908335
Cardio-respiratory arrest 442.71 13.99 418 38860 54855 34862798
Electrocardiogram QT prolonged 409.38 13.99 351 38927 40601 34877052
Death 398.40 13.99 1159 38119 396890 34520763
Asphyxia 339.92 13.99 162 39116 6673 34910980
Cardiac arrest 317.48 13.99 461 38817 95698 34821955
Completed suicide 308.75 13.99 460 38818 97708 34819945
Withdrawal syndrome 271.32 13.99 171 39107 12284 34905369
Bradypnoea 262.05 13.99 104 39174 2725 34914928
Torsade de pointes 253.11 13.99 135 39143 7074 34910579
Drug interaction 250.18 13.99 684 38594 225262 34692391
Drug withdrawal syndrome 248.46 13.99 194 39084 19640 34898013
Depressed level of consciousness 244.35 13.99 270 39008 42571 34875082
Drug withdrawal syndrome neonatal 243.83 13.99 106 39172 3513 34914140
Substance abuse 234.77 13.99 131 39147 7510 34910143
Somnolence 196.26 13.99 404 38874 110712 34806941
Accidental overdose 195.72 13.99 170 39108 19970 34897683
Unresponsive to stimuli 185.92 13.99 190 39088 27379 34890274
Pulmonary oedema 183.63 13.99 246 39032 47283 34870370
Serotonin syndrome 173.31 13.99 158 39120 19775 34897878
Drug diversion 163.10 13.99 54 39224 825 34916828
Brain oedema 151.38 13.99 125 39153 13696 34903957
Prescription drug used without a prescription 151.35 13.99 65 39213 2089 34915564
Diarrhoea 125.19 13.99 153 39125 389759 34527894
Drug use disorder 107.76 13.99 64 39214 4127 34913526
Exposure via ingestion 100.26 13.99 49 39229 2132 34915521
Hepatic fibrosis 99.66 13.99 63 39215 4544 34913109
Myocardial fibrosis 97.07 13.99 40 39238 1157 34916496
Brain injury 87.72 13.99 65 39213 6077 34911576
Drug screen positive 85.49 13.99 54 39224 3889 34913764
Victim of child abuse 82.10 13.99 33 39245 894 34916759
Delirium 81.09 13.99 163 39115 43828 34873825
Housebound 79.73 13.99 23 39255 215 34917438
Pyrexia 79.70 13.99 159 39119 332854 34584799
Poisoning deliberate 75.74 13.99 66 39212 7778 34909875
Hyperaesthesia 72.94 13.99 52 39226 4578 34913075
Rhabdomyolysis 71.67 13.99 203 39075 67960 34849693
Neutropenia 71.34 13.99 44 39234 156734 34760919
Atrial fibrillation 68.37 13.99 26 39252 122367 34795286
Cough 67.12 13.99 43 39235 150097 34767556
Compartment syndrome 67.10 13.99 42 39236 2976 34914677
Cardiopulmonary failure 66.33 13.99 47 39231 4098 34913555
Pneumonia aspiration 65.31 13.99 145 39133 41758 34875895
Intentional overdose 62.38 13.99 146 39132 43528 34874125
Epidural lipomatosis 61.76 13.99 28 39250 1026 34916627
Sopor 61.48 13.99 72 39206 12064 34905589
General physical health deterioration 61.17 13.99 34 39244 128235 34789418
Agitation 60.38 13.99 171 39107 57228 34860425
Febrile neutropenia 60.07 13.99 40 39238 136809 34780844
Foetal exposure during pregnancy 59.55 13.99 132 39146 37969 34879684
Hepatitis C 59.52 13.99 64 39214 9766 34907887
Respiratory acidosis 58.06 13.99 47 39231 5003 34912650
Condition aggravated 56.75 13.99 80 39198 192116 34725537
Laryngomalacia 56.06 13.99 19 39259 313 34917340
Brachial plexopathy 53.86 13.99 13 39265 55 34917598
Ventricular tachyarrhythmia 53.84 13.99 19 39259 355 34917298
Dyspnoea 53.51 13.99 230 39048 376552 34541101
Drug-induced liver injury 53.31 13.99 107 39171 28725 34888928
Off label use 52.58 13.99 268 39010 419256 34498397
Hypercapnia 51.90 13.99 41 39237 4214 34913439
Drug tolerance 51.56 13.99 35 39243 2847 34914806
Child abuse 51.38 13.99 19 39259 408 34917245
Pulmonary congestion 51.19 13.99 70 39208 13695 34903958
Accidental exposure to product by child 50.00 13.99 27 39251 1449 34916204
Sepsis 49.48 13.99 69 39209 166492 34751161
Interstitial lung disease 47.68 13.99 8 39270 65274 34852379
Asthenia 47.42 13.99 131 39147 245120 34672533
Juvenile idiopathic arthritis 46.25 13.99 28 39250 1869 34915784
Postmortem blood drug level abnormal 46.05 13.99 16 39262 285 34917368
Sedation 45.02 13.99 83 39195 20923 34896730
Visceral congestion 44.22 13.99 19 39259 611 34917042
Toxicologic test abnormal 43.12 13.99 18 39260 538 34917115
Cardiac failure congestive 42.77 13.99 20 39258 83250 34834403
Cardiac failure 42.32 13.99 25 39253 91223 34826430
Substance dependence 42.29 13.99 16 39262 367 34917286
Withdrawal arrhythmia 41.88 13.99 10 39268 40 34917613
Hypoxic-ischaemic encephalopathy 41.48 13.99 37 39241 4495 34913158
COVID-19 40.81 13.99 18 39260 77532 34840121
Substance use disorder 40.36 13.99 19 39259 760 34916893
Arthralgia 39.85 13.99 82 39196 169959 34747694
Leukoencephalopathy 39.75 13.99 35 39243 4180 34913473
Platelet count decreased 39.26 13.99 46 39232 119671 34797982
Pleural effusion 38.30 13.99 22 39256 81524 34836129
Acute kidney injury 38.02 13.99 195 39083 304793 34612860
Rash 38.01 13.99 126 39152 222626 34695027
Aspiration 37.98 13.99 57 39221 12137 34905516
Loss of consciousness 36.15 13.99 186 39092 82481 34835172
Myocardial infarction 35.10 13.99 51 39227 121034 34796619
Fatigue 33.82 13.99 261 39017 370392 34547261
Regurgitation 33.69 13.99 22 39256 1677 34915976
Encephalopathy 33.08 13.99 101 39177 35218 34882435
Disease progression 32.84 13.99 44 39234 108033 34809620
Pneumonia 32.77 13.99 256 39022 362371 34555282
Hyponatraemia 32.60 13.99 27 39251 82664 34834989
Incorrect route of product administration 32.24 13.99 59 39219 14786 34902867
Postmortem blood drug level 31.97 13.99 11 39267 190 34917463
Anaemia 30.88 13.99 146 39132 233189 34684464
Foetal growth restriction 30.72 13.99 30 39248 4087 34913566
Decreased appetite 30.55 13.99 91 39187 166301 34751352
Suicide attempt 30.44 13.99 105 39173 39011 34878642
Myoclonus 30.07 13.99 57 39221 14668 34902985
Sudden death 30.01 13.99 58 39220 15143 34902510
Stress cardiomyopathy 29.87 13.99 22 39256 2037 34915616
Sudden cardiac death 29.56 13.99 28 39250 3673 34913980
Hypercapnic coma 29.38 13.99 10 39268 167 34917486
Dizziness 29.34 13.99 136 39142 218385 34699268
Ectopic kidney 29.12 13.99 7 39271 29 34917624
White blood cell count decreased 28.85 13.99 39 39239 95406 34822247
Prostate cancer 28.63 13.99 5 39273 39644 34878009
Dependence 28.10 13.99 17 39261 1133 34916520
Pruritus 28.02 13.99 75 39203 141906 34775747
Brachial plexus injury 27.90 13.99 8 39270 73 34917580
Product prescribing error 27.79 13.99 72 39206 22855 34894798
Biliary dilatation 27.65 13.99 16 39262 982 34916671
Cerebrovascular accident 27.35 13.99 33 39245 84778 34832875
Substance use 27.21 13.99 14 39264 680 34916973
Oedema peripheral 27.02 13.99 59 39219 119753 34797900
Electrocardiogram QT shortened 26.74 13.99 9 39269 145 34917508
IVth nerve disorder 26.46 13.99 6 39272 18 34917635
Drug level increased 26.38 13.99 69 39209 22027 34895626
Renal vein thrombosis 25.76 13.99 9 39269 163 34917490
Asthma 25.63 13.99 8 39270 42648 34875005
Joint swelling 25.59 13.99 18 39260 59872 34857781
Drug withdrawal maintenance therapy 25.49 13.99 8 39270 102 34917551
Mental status changes 25.21 13.99 97 39181 37986 34879667
Haemoglobin decreased 25.20 13.99 62 39216 120710 34796943
Respiratory rate decreased 25.12 13.99 21 39257 2338 34915315
Drug detoxification 25.08 13.99 10 39268 265 34917388
Renal failure 24.98 13.99 70 39208 130487 34787166
Dehydration 24.63 13.99 70 39208 129899 34787754
Self-medication 24.61 13.99 22 39256 2681 34914972
Cyanosis 24.34 13.99 48 39230 12716 34904937
Product communication issue 24.26 13.99 11 39267 403 34917250
Haematuria 24.23 13.99 13 39265 50053 34867600
Postoperative ileus 24.12 13.99 13 39265 695 34916958
Bladder dilatation 24.06 13.99 17 39261 1475 34916178
Altered state of consciousness 23.85 13.99 68 39210 22825 34894828
Thrombocytopenia 23.56 13.99 93 39185 156154 34761499
International normalised ratio increased 23.33 13.99 12 39266 47315 34870338
Product dose omission issue 23.04 13.99 64 39214 119647 34798006
Renal impairment 22.61 13.99 45 39233 94468 34823185
Blood glucose increased 22.54 13.99 25 39253 66693 34850960
Aspartate aminotransferase increased 22.25 13.99 26 39252 67757 34849896
Muscle mass 22.01 13.99 9 39269 255 34917398
Erythema 21.47 13.99 42 39236 88738 34828915
Dyspnoea exertional 21.30 13.99 11 39267 43268 34874385
Blood creatinine increased 21.22 13.99 47 39231 94929 34822724
Drug level above therapeutic 21.11 13.99 25 39253 4236 34913417
Transient ischaemic attack 21.03 13.99 3 39275 27610 34890043
Confusional state 21.01 13.99 251 39027 143909 34773744
Withdrawal hypertension 20.77 13.99 8 39270 193 34917460
Central nervous system necrosis 20.45 13.99 7 39271 119 34917534
Urticaria 20.39 13.99 24 39254 62353 34855300
Coronary artery disease 20.01 13.99 15 39263 48290 34869363
Rheumatoid arthritis 19.91 13.99 9 39269 38229 34879424
Sinusitis 19.67 13.99 11 39267 41391 34876262
Pneumoconiosis 19.62 13.99 8 39270 225 34917428
Accidental exposure to product 19.59 13.99 44 39234 12758 34904895
Myocardial oedema 19.59 13.99 8 39270 226 34917427
Cataract 19.58 13.99 3 39275 26183 34891470
Hypersensitivity 19.41 13.99 24 39254 61011 34856642
Alcohol abuse 19.20 13.99 25 39253 4665 34912988
Arachnoiditis 19.00 13.99 9 39269 365 34917288
Musculoskeletal stiffness 18.69 13.99 15 39263 46665 34870988
Leukopenia 18.67 13.99 26 39252 62830 34854823
Dysarthria 18.62 13.99 83 39195 34699 34882954
Neutrophil count decreased 18.56 13.99 18 39260 51086 34866567
Accidental death 18.52 13.99 18 39260 2438 34915215
Hospitalisation 18.49 13.99 22 39256 56880 34860773
Toxic encephalopathy 18.47 13.99 26 39252 5223 34912430
Abdominal pain 18.47 13.99 108 39170 163510 34754143
Extramedullary haemopoiesis 18.34 13.99 6 39272 88 34917565
Drug intolerance 18.34 13.99 24 39254 59546 34858107
Colitis 17.98 13.99 10 39268 37740 34879913
Mononeuropathy 17.92 13.99 6 39272 95 34917558
Apnoea 17.76 13.99 29 39249 6635 34911018
Angioedema 17.66 13.99 10 39268 37364 34880289
Visceral oedema 17.64 13.99 6 39272 100 34917553
Diabetes mellitus 17.62 13.99 16 39262 46857 34870796
Substance-induced psychotic disorder 17.54 13.99 15 39263 1723 34915930
Product administered to patient of inappropriate age 17.46 13.99 20 39258 3271 34914382
Melaena 17.40 13.99 9 39269 35371 34882282
Foetal heart rate indeterminate 17.38 13.99 3 39275 0 34917653
Haematochezia 17.36 13.99 16 39262 46518 34871135
Intentional misuse of drug delivery system 17.17 13.99 4 39274 14 34917639
Intentional device misuse 17.16 13.99 7 39271 197 34917456
Neuropathy peripheral 17.16 13.99 43 39235 83220 34834433
Maternal exposure during breast feeding 16.99 13.99 14 39264 1527 34916126
Drug tolerance increased 16.94 13.99 9 39269 467 34917186
Lethargy 16.91 13.99 91 39187 41031 34876622
Chronic obstructive pulmonary disease 16.89 13.99 18 39260 48900 34868753
Productive cough 16.64 13.99 11 39267 37802 34879851
Congenital hypothyroidism 16.56 13.99 4 39274 17 34917636
Fall 16.55 13.99 147 39131 202738 34714915
Device toxicity 16.37 13.99 4 39274 18 34917635
Tachycardia 16.26 13.99 156 39122 84616 34833037
Weight increased 16.26 13.99 52 39226 92981 34824672
Ascites 16.23 13.99 17 39261 46554 34871099
Hyperreflexia 16.20 13.99 19 39259 3187 34914466
Bronchitis 16.16 13.99 14 39264 41949 34875704
Elbow synostosis 16.03 13.99 4 39274 20 34917633
Sudden infant death syndrome 15.85 13.99 7 39271 241 34917412
Infection 15.76 13.99 51 39227 90864 34826789
Chloasma 15.71 13.99 4 39274 22 34917631
Chronic kidney disease 15.57 13.99 14 39264 41196 34876457
Cluster headache 15.49 13.99 9 39269 557 34917096
C-reactive protein increased 15.45 13.99 23 39255 54075 34863578
Ventricular tachycardia 15.43 13.99 65 39213 26514 34891139
Peripheral swelling 15.41 13.99 40 39238 76501 34841152
Product use in unapproved indication 15.23 13.99 74 39204 117425 34800228
Testicular atrophy 15.11 13.99 9 39269 583 34917070
Accidental poisoning 15.11 13.99 10 39268 780 34916873
Chronic hepatitis C 15.03 13.99 8 39270 417 34917236
Alanine aminotransferase increased 14.95 13.99 44 39234 80771 34836882
Therapeutic product effect incomplete 14.91 13.99 21 39257 50520 34867133
Nerve injury 14.80 13.99 19 39259 3496 34914157
Gastric bypass 14.64 13.99 7 39271 290 34917363
Epistaxis 14.56 13.99 27 39251 58224 34859429
Aggression 14.54 13.99 84 39194 38880 34878773
Deafness neurosensory 14.48 13.99 17 39261 2854 34914799
Gastrointestinal haemorrhage 14.40 13.99 51 39227 88426 34829227
Chills 14.37 13.99 45 39233 80998 34836655
Coma scale abnormal 14.32 13.99 20 39258 3988 34913665
Euphoric mood 14.30 13.99 24 39254 5617 34912036
Acute myocardial infarction 14.24 13.99 24 39254 53695 34863958
Pericardial effusion 14.16 13.99 5 39273 24657 34892996
Sickle cell anaemia with crisis 14.15 13.99 20 39258 4033 34913620
Incoherent 14.13 13.99 21 39257 4431 34913222
Hygroma colli 14.10 13.99 4 39274 35 34917618
Oral tuberculosis 14.09 13.99 3 39275 6 34917647

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 7627.01 12.53 3276 58074 159415 79523623
Toxicity to various agents 5200.31 12.53 3486 57864 418054 79264984
Respiratory depression 1488.72 12.53 618 60732 27012 79656026
Respiratory arrest 1327.58 12.53 717 60633 56833 79626205
Completed suicide 1131.95 12.53 1155 60195 244612 79438426
Death 1039.53 12.53 1683 59667 564831 79118207
Cardio-respiratory arrest 1014.74 12.53 764 60586 107746 79575292
Overdose 989.29 12.53 942 60408 183264 79499774
Cardiac arrest 927.61 12.53 882 60468 171214 79511824
Intentional product misuse 925.21 12.53 686 60664 94479 79588559
Poisoning 752.31 12.53 374 60976 24898 79658140
Drug dependence 746.87 12.53 437 60913 40332 79642706
Coma 582.11 12.53 537 60813 100112 79582926
Miosis 570.75 12.53 267 61083 15522 79667516
Electrocardiogram QT prolonged 493.22 12.53 467 60883 89919 79593119
Torsade de pointes 482.39 12.53 254 61096 19058 79663980
Drug withdrawal syndrome 477.34 12.53 310 61040 34408 79648630
Asphyxia 432.27 12.53 201 61149 11519 79671519
Depressed level of consciousness 396.48 12.53 428 60922 96224 79586814
Accidental overdose 385.59 12.53 286 61064 39295 79643743
Drug interaction 378.84 12.53 923 60427 414260 79268778
Bradypnoea 320.99 12.53 134 61216 5918 79677120
Substance abuse 319.70 12.53 158 61192 10368 79672670
Unresponsive to stimuli 313.24 12.53 293 61057 55495 79627543
Withdrawal syndrome 288.68 12.53 206 61144 26648 79656390
Somnolence 277.29 12.53 585 60765 238396 79444642
Premature delivery 263.78 12.53 185 61165 23282 79659756
Congenital nystagmus 213.14 12.53 40 61310 53 79682985
Suicide attempt 210.28 12.53 288 61062 82644 79600394
Pulmonary oedema 199.35 12.53 290 61060 87964 79595074
Exposure via ingestion 197.82 12.53 91 61259 5083 79677955
Hyperaesthesia 184.96 12.53 116 61234 12106 79670932
Drug diversion 176.67 12.53 57 61293 1193 79681845
Brain oedema 167.98 12.53 146 61204 25117 79657921
Intentional overdose 166.30 12.53 295 61055 105665 79577373
Diarrhoea 156.73 12.53 274 61076 880215 78802823
Serotonin syndrome 154.75 12.53 182 61168 44845 79638193
Drug use disorder 148.51 12.53 89 61261 8562 79674476
Strabismus congenital 131.49 12.53 24 61326 24 79683014
Accidental exposure to product by child 129.48 12.53 57 61293 2869 79680169
Delirium 118.09 12.53 224 61126 84403 79598635
Drug withdrawal syndrome neonatal 115.96 12.53 30 61320 273 79682765
Poisoning deliberate 113.60 12.53 103 61247 18725 79664313
Myocardial fibrosis 108.07 12.53 43 61307 1675 79681363
Prescription drug used without a prescription 105.59 12.53 55 61295 4030 79679008
Pneumonia aspiration 103.17 12.53 185 61165 66782 79616256
Respiratory acidosis 100.29 12.53 77 61273 11123 79671915
Cardiopulmonary failure 99.02 12.53 63 61287 6738 79676300
Agitation 98.35 12.53 229 61121 99486 79583552
Housebound 98.16 12.53 29 61321 447 79682591
Rash 96.39 12.53 187 61163 578171 79104867
Hepatic fibrosis 95.10 12.53 63 61287 7217 79675821
Victim of child abuse 93.37 12.53 33 61317 920 79682118
Cough 93.13 12.53 87 61263 366702 79316336
Leukoencephalopathy 92.57 12.53 64 61286 7865 79675173
Hypoxic-ischaemic encephalopathy 88.67 12.53 62 61288 7758 79675280
Pyrexia 88.64 12.53 250 61100 678459 79004579
Drug screen positive 87.87 12.53 56 61294 6007 79677031
General physical health deterioration 84.17 12.53 54 61296 275184 79407854
Brain injury 83.57 12.53 70 61280 11447 79671591
Arthralgia 81.94 12.53 201 61149 571602 79111436
Rheumatoid arthritis 80.23 12.53 30 61320 208440 79474598
Fatigue 80.14 12.53 406 60944 929321 78753717
Joint swelling 79.90 12.53 63 61287 288583 79394455
Drug intolerance 77.82 12.53 54 61296 264065 79418973
Infusion related reaction 77.76 12.53 40 61310 230197 79452841
Maternal exposure during pregnancy 77.28 12.53 256 61094 136282 79546756
Pruritus 77.26 12.53 115 61235 394533 79288505
Accidental poisoning 75.66 12.53 33 61317 1624 79681414
Rhabdomyolysis 73.88 12.53 210 61140 102921 79580117
Drug abuser 73.66 12.53 50 61300 5963 79677075
Synovitis 72.45 12.53 14 61336 150720 79532318
Sinusitis 72.16 12.53 30 61320 195471 79487567
Atrial fibrillation 72.03 12.53 31 61319 197855 79485183
Pulmonary congestion 71.49 12.53 96 61254 27004 79656034
Visceral congestion 71.02 12.53 27 61323 929 79682109
Systemic lupus erythematosus 70.81 12.53 6 61344 121143 79561895
Mental status changes 69.57 12.53 157 61193 66802 79616236
Toxic leukoencephalopathy 69.53 12.53 28 61322 1126 79681912
Abdominal discomfort 69.03 12.53 55 61295 250672 79432366
Hypersensitivity 67.95 12.53 61 61289 262178 79420860
Epidural lipomatosis 67.84 12.53 28 61322 1200 79681838
Alopecia 67.22 12.53 48 61302 231307 79451731
Nasopharyngitis 67.05 12.53 58 61292 253823 79429215
Sedation 64.65 12.53 131 61219 51764 79631274
Substance use disorder 64.35 12.53 25 61325 913 79682125
Pericarditis 64.25 12.53 4 61346 104232 79578806
Hepatitis C 63.76 12.53 61 61289 11864 79671174
Glossodynia 63.59 12.53 4 61346 103333 79579705
Dizziness 63.53 12.53 201 61149 526240 79156798
Compartment syndrome 61.64 12.53 42 61308 5040 79677998
Urticaria 61.31 12.53 33 61317 185168 79497870
Neutropenia 61.12 12.53 79 61271 287631 79395407
Arthropathy 60.95 12.53 30 61320 177081 79505957
Infection 60.52 12.53 58 61292 241654 79441384
Dyspnoea 58.98 12.53 402 60948 856623 78826415
Asthenia 58.53 12.53 200 61150 511489 79171549
Child abuse 58.34 12.53 19 61331 410 79682628
Substance use 57.44 12.53 23 61327 911 79682127
Ventricular tachycardia 57.24 12.53 110 61240 41825 79641213
Peripheral swelling 56.27 12.53 75 61275 269542 79413496
Accidental death 55.73 12.53 37 61313 4254 79678784
Myoclonus 55.42 12.53 86 61264 27574 79655464
Foetal exposure during pregnancy 54.47 12.53 41 61309 5749 79677289
Hypercapnia 54.13 12.53 49 61301 8886 79674152
Cyanosis 52.85 12.53 80 61270 25102 79657936
Condition aggravated 51.96 12.53 204 61146 500920 79182118
Therapeutic product effect decreased 51.65 12.53 31 61319 163832 79519206
Substance dependence 51.47 12.53 18 61332 486 79682552
COVID-19 50.87 12.53 29 61321 157645 79525393
Swelling 50.83 12.53 55 61295 216656 79466382
Sopor 50.57 12.53 91 61259 32919 79650119
Off label use 50.51 12.53 451 60899 906764 78776274
Discomfort 50.15 12.53 17 61333 125600 79557438
Febrile neutropenia 49.49 12.53 63 61287 230936 79452102
Erythema 48.77 12.53 60 61290 223230 79459808
Hyponatraemia 47.71 12.53 40 61310 177808 79505230
Loss of consciousness 47.70 12.53 255 61095 167688 79515350
Brachial plexopathy 46.85 12.53 13 61337 158 79682880
Contraindicated product administered 46.65 12.53 32 61318 157506 79525532
Withdrawal arrhythmia 45.65 12.53 10 61340 40 79682998
Hepatic enzyme increased 45.48 12.53 44 61306 182566 79500472
Stress cardiomyopathy 44.92 12.53 49 61301 11117 79671921
Drug level increased 44.60 12.53 96 61254 39555 79643483
Encephalopathy 44.19 12.53 133 61217 67264 79615774
Drug withdrawal maintenance therapy 43.50 12.53 10 61340 52 79682986
Anaemia 43.08 12.53 186 61164 444829 79238209
Contusion 43.02 12.53 31 61319 148745 79534293
Hypercapnic coma 42.75 12.53 15 61335 409 79682629
Congenital visual acuity reduced 42.46 12.53 8 61342 11 79683027
Sudden death 42.35 12.53 68 61282 22443 79660595
Chorea 41.83 12.53 25 61325 2392 79680646
Aspiration 40.84 12.53 63 61287 20095 79662943
Pain 40.82 12.53 346 61004 703456 78979582
Cardiac failure congestive 40.75 12.53 30 61320 142372 79540666
Treatment failure 40.27 12.53 43 61307 170443 79512595
Postmortem blood drug level abnormal 39.86 12.53 16 61334 638 79682400
Aggression 39.68 12.53 107 61243 50851 79632187
Duodenal ulcer perforation 39.46 12.53 3 61347 66208 79616830
Stomatitis 39.37 12.53 33 61317 146724 79536314
Long QT syndrome 38.74 12.53 34 61316 5921 79677117
Drug-induced liver injury 38.30 12.53 125 61225 65992 79617046
Asthma 37.96 12.53 29 61321 135066 79547972
Alcohol abuse 37.68 12.53 32 61318 5331 79677707
Arthritis 37.24 12.53 21 61329 114859 79568179
Toxicologic test abnormal 37.13 12.53 19 61331 1341 79681697
Cardiac failure 36.63 12.53 39 61311 154803 79528235
Irritable bowel syndrome 36.59 12.53 3 61347 62238 79620800
Ill-defined disorder 36.54 12.53 4 61346 65871 79617167
Psoriatic arthropathy 35.91 12.53 8 61342 77991 79605047
Postoperative ileus 35.37 12.53 17 61333 1048 79681990
Gastrointestinal disorder 34.63 12.53 26 61324 122179 79560859
Interstitial lung disease 34.51 12.53 22 61328 112578 79570460
Catatonia 34.49 12.53 38 61312 8718 79674320
Altered state of consciousness 34.10 12.53 92 61258 43730 79639308
Pneumoconiosis 33.79 12.53 11 61339 237 79682801
Incoherent 33.13 12.53 35 61315 7657 79675381
Developmental delay 33.04 12.53 17 61333 1214 79681824
Juvenile idiopathic arthritis 32.61 12.53 28 61322 4735 79678303
Decreased appetite 32.58 12.53 144 61206 342274 79340764
Wound 32.56 12.53 25 61325 116154 79566884
Musculoskeletal stiffness 32.28 12.53 53 61297 174955 79508083
Drug ineffective 31.73 12.53 614 60736 1080299 78602739
Sepsis 31.64 12.53 104 61246 269324 79413714
Impaired healing 31.45 12.53 14 61336 87641 79595397
Regurgitation 31.37 12.53 22 61328 2765 79680273
Pain in extremity 31.34 12.53 159 61191 364379 79318659
Blood cholesterol increased 30.63 12.53 13 61337 83707 79599331
Respiratory rate decreased 30.29 12.53 28 61322 5215 79677823
Product dose omission issue 30.15 12.53 94 61256 247443 79435595
Postmortem blood drug level 30.14 12.53 11 61339 337 79682701
Drug tolerance increased 30.11 12.53 13 61337 624 79682414
Osteoarthritis 29.70 12.53 15 61335 87294 79595744
Blister 29.50 12.53 29 61321 119447 79563591
Lethargy 29.18 12.53 132 61218 81160 79601878
IVth nerve disorder 28.72 12.53 6 61344 18 79683020
Sudden cardiac death 28.45 12.53 27 61323 5198 79677840
Urinary tract infection 28.23 12.53 112 61238 274400 79408638
Central nervous system necrosis 28.15 12.53 10 61340 283 79682755
Platelet count decreased 28.13 12.53 68 61282 194596 79488442
Suspected counterfeit product 27.83 12.53 12 61338 574 79682464
Brachial plexus injury 27.59 12.53 8 61342 115 79682923
Hyperreflexia 27.32 12.53 33 61317 8352 79674686
Oedema peripheral 27.19 12.53 101 61249 252187 79430851
Chest discomfort 27.18 12.53 40 61310 138004 79545034
Chest pain 26.67 12.53 119 61231 282185 79400853
Electrocardiogram QT shortened 26.66 12.53 9 61341 218 79682820
Headache 26.62 12.53 349 61001 653423 79029615
Chronic hepatitis C 26.58 12.53 12 61338 641 79682397
Malaise 26.51 12.53 245 61105 489624 79193414
Injection site reaction 26.50 12.53 5 61345 54780 79628258
Hypoaesthesia 26.43 12.53 62 61288 179290 79503748
Toxic encephalopathy 26.39 12.53 38 61312 11402 79671636
Injection site pain 26.18 12.53 37 61313 129801 79553237
Crying 26.15 12.53 56 61294 22987 79660051
Restlessness 26.12 12.53 87 61263 46405 79636633
Myocardial infarction 26.07 12.53 65 61285 184064 79498974
Productive cough 26.06 12.53 18 61332 88313 79594725
Acute kidney injury 25.90 12.53 265 61085 519139 79163899
Allodynia 25.83 12.53 16 61334 1632 79681406
Aspartate aminotransferase increased 25.55 12.53 42 61308 138599 79544439
Suicidal ideation 25.22 12.53 121 61229 76219 79606819
Drug detoxification 25.05 12.53 10 61340 393 79682645
Pleural effusion 24.96 12.53 46 61304 145216 79537822
Herpes zoster 24.87 12.53 21 61329 93062 79589976
Drug tolerance 24.84 12.53 32 61318 8643 79674395
Coma scale abnormal 24.83 12.53 32 61318 8646 79674392
Rash pruritic 24.83 12.53 12 61338 71617 79611421
Narcotic bowel syndrome 24.81 12.53 9 61341 271 79682767
Post-anoxic myoclonus 24.71 12.53 6 61344 41 79682997
Palpitations 24.62 12.53 37 61313 126573 79556465
Confusional state 24.60 12.53 362 60988 317635 79365403
Exposure via breast milk 24.57 12.53 13 61337 983 79682055
Angioedema 24.49 12.53 14 61336 76021 79607017
Affective disorder 24.31 12.53 31 61319 8288 79674750
Alanine aminotransferase increased 24.11 12.53 56 61294 162514 79520524
Musculoskeletal pain 23.96 12.53 26 61324 102328 79580710
Abdominal pain upper 23.86 12.53 90 61260 223729 79459309
Gastrooesophageal reflux disease 23.83 12.53 27 61323 104219 79578819
Product communication issue 23.71 12.53 13 61337 1056 79681982
Optic nerve hypoplasia 23.69 12.53 5 61345 16 79683022
Nausea 23.59 12.53 559 60791 956637 78726401
Product prescribing error 23.54 12.53 82 61268 44731 79638307
Knee arthroplasty 23.06 12.53 3 61347 43245 79639793
Apnoea 22.90 12.53 36 61314 11668 79671370
Fall 22.61 12.53 253 61097 487376 79195662
Disease progression 22.45 12.53 70 61280 184292 79498746
Tachycardia 22.37 12.53 222 61128 177546 79505492
Cerebral vasoconstriction 22.36 12.53 14 61336 1456 79681582
Testicular atrophy 22.35 12.53 9 61341 362 79682676
Chills 22.34 12.53 57 61293 160177 79522861
Paraesthesia 22.14 12.53 66 61284 176257 79506781
Self-medication 21.48 12.53 23 61327 5109 79677929
Drug eruption 21.27 12.53 4 61346 43931 79639107
Hyperinsulinaemic hypoglycaemia 21.16 12.53 7 61343 159 79682879
Incorrect route of product administration 21.10 12.53 67 61283 34862 79648176
Basal ganglia infarction 21.06 12.53 10 61340 600 79682438
Myelosuppression 21.00 12.53 3 61347 40293 79642745
Cardio-respiratory distress 21.00 12.53 8 61342 277 79682761
Diabetic hyperglycaemic coma 20.65 12.53 6 61344 87 79682951
Pulmonary haemorrhage 20.56 12.53 39 61311 14678 79668360
White blood cell count decreased 20.53 12.53 75 61275 188213 79494825
Fibromyalgia 20.51 12.53 12 61338 64328 79618710
Thyroxine decreased 20.43 12.53 11 61339 862 79682176
Muscle mass 20.40 12.53 9 61341 455 79682583
Hepatotoxicity 20.40 12.53 7 61343 51345 79631693
Anaphylactic reaction 19.90 12.53 21 61329 83722 79599316
Inadequate analgesia 19.83 12.53 21 61329 4608 79678430
Brain death 19.58 12.53 23 61327 5654 79677384
Lower respiratory tract infection 19.57 12.53 44 61306 129176 79553862
Haemoglobin decreased 19.57 12.53 96 61254 222023 79461015
Paranoia 19.55 12.53 45 61305 19387 79663651
C-reactive protein increased 19.49 12.53 44 61306 128983 79554055
Abnormal dreams 19.48 12.53 33 61317 11379 79671659
Substance-induced psychotic disorder 19.39 12.53 18 61332 3371 79679667
International normalised ratio increased 19.30 12.53 22 61328 84699 79598339
Visceral oedema 19.29 12.53 6 61344 111 79682927
Dehydration 19.24 12.53 112 61238 248075 79434963
Leukopenia 19.05 12.53 38 61312 116475 79566563
Intentional misuse of drug delivery system 18.91 12.53 4 61346 13 79683025
Accidental exposure to product 18.84 12.53 60 61290 31262 79651776
Neutrophil count decreased 18.71 12.53 27 61323 93932 79589106
Withdrawal hypertension 18.69 12.53 8 61342 376 79682662
Inflammation 18.61 12.53 27 61323 93726 79589312
Myocardial oedema 18.47 12.53 8 61342 387 79682651
Accident 18.45 12.53 28 61322 8803 79674235
Dyspnoea exertional 18.37 12.53 24 61326 87049 79595989
Thrombocytopenia 18.35 12.53 124 61226 265135 79417903
Biliary dilatation 18.31 12.53 16 61334 2770 79680268
Snoring 18.29 12.53 22 61328 5544 79677494
Lung disorder 18.26 12.53 21 61329 80536 79602502
Neurological examination abnormal 18.24 12.53 9 61341 588 79682450
Wrong product administered 18.02 12.53 28 61322 8984 79674054
Mydriasis 17.90 12.53 41 61309 17602 79665436
Device toxicity 17.88 12.53 4 61346 18 79683020
Cataract 17.88 12.53 13 61337 62107 79620931
Sickle cell anaemia with crisis 17.82 12.53 26 61324 7896 79675142
Injection site swelling 17.75 12.53 7 61343 47125 79635913
Bladder dilatation 17.74 12.53 14 61336 2105 79680933
Respiratory failure 17.72 12.53 215 61135 180696 79502342
Haematoma 17.70 12.53 9 61341 52186 79630852
Epistaxis 17.69 12.53 37 61313 111478 79571560
Haematochezia 17.64 12.53 25 61325 87620 79595418
Sudden infant death syndrome 17.46 12.53 7 61343 278 79682760
Injection site bruising 17.34 12.53 5 61345 40997 79642041
Loss of personal independence in daily activities 17.16 12.53 33 61317 102547 79580491
Fluid retention 17.16 12.53 17 61333 69792 79613246
Rash maculo-papular 17.12 12.53 11 61339 56067 79626971
Abdominal distension 17.12 12.53 42 61308 119608 79563430
Euphoric mood 16.86 12.53 25 61325 7701 79675337
Brain hypoxia 16.77 12.53 10 61340 953 79682085
Pupil fixed 16.75 12.53 17 61333 3549 79679489
Emphysema 16.67 12.53 38 61312 16262 79666776
Weight increased 16.64 12.53 135 61215 277251 79405787
Cystitis 16.57 12.53 10 61340 52722 79630316
Microcephaly 16.56 12.53 6 61344 180 79682858
Cluster headache 16.46 12.53 10 61340 986 79682052
Bronchitis 16.33 12.53 49 61301 130595 79552443
Blood lactate dehydrogenase increased 16.16 12.53 5 61345 39165 79643873
Diabetes mellitus 16.14 12.53 22 61328 78368 79604670
Blood glucose increased 15.95 12.53 41 61309 114934 79568104
Arachnoiditis 15.94 12.53 9 61341 774 79682264
Myalgia 15.91 12.53 81 61269 185560 79497478
Pulmonary fibrosis 15.89 12.53 7 61343 44105 79638933
Mobility decreased 15.87 12.53 45 61305 122130 79560908
Hip arthroplasty 15.80 12.53 4 61346 35752 79647286
Potentiating drug interaction 15.72 12.53 26 61324 8793 79674245
Mononeuropathy 15.69 12.53 6 61344 210 79682828
Hypoxia 15.53 12.53 134 61216 103109 79579929
Blood pressure increased 15.53 12.53 97 61253 211263 79471775
Chloasma 15.40 12.53 4 61346 37 79683001
Hyperglycaemia 15.24 12.53 19 61331 70316 79612722
Liver disorder 15.23 12.53 20 61330 72397 79610641
Eosinophilia 15.11 12.53 8 61342 45337 79637701
Injection site erythema 15.06 12.53 23 61327 78174 79604864
Cerebrovascular accident 14.93 12.53 65 61285 155227 79527811
Diffuse alveolar damage 14.82 12.53 16 61334 3588 79679450
Radiation associated pain 14.74 12.53 5 61345 123 79682915
Blood pressure fluctuation 14.69 12.53 18 61332 67127 79615911
Upper respiratory tract infection 14.67 12.53 30 61320 91138 79591900
Blood pressure systolic increased 14.61 12.53 18 61332 66968 79616070
Renal impairment 14.59 12.53 67 61283 157716 79525322
Drug level above therapeutic 14.59 12.53 25 61325 8698 79674340
Cardiac death 14.48 12.53 11 61339 1563 79681475
Hepatitis 14.37 12.53 13 61337 55714 79627324
Bone marrow failure 14.31 12.53 11 61339 51096 79631942
Heart rate decreased 14.21 12.53 20 61330 70296 79612742
Respiratory distress 14.18 12.53 85 61265 58254 79624784
C-reactive protein abnormal 14.08 12.53 10 61340 48357 79634681
Mouth ulceration 13.98 12.53 6 61344 38388 79644650
Transient ischaemic attack 13.94 12.53 12 61338 52683 79630355
Hypoventilation 13.83 12.53 22 61328 7202 79675836
Colitis 13.70 12.53 22 61328 73285 79609753
Oral tuberculosis 13.69 12.53 3 61347 12 79683026
Myocardial necrosis 13.68 12.53 7 61343 494 79682544
Melaena 13.66 12.53 16 61334 60874 79622164
Left ventricular hypertrophy 13.63 12.53 28 61322 11163 79671875
Breakthrough pain 13.63 12.53 10 61340 1349 79681689
Lymphocyte count decreased 13.47 12.53 10 61340 47279 79635759
Angina pectoris 13.42 12.53 12 61338 51720 79631318
Flushing 13.41 12.53 30 61320 88238 79594800
Blood pressure decreased 13.39 12.53 36 61314 99430 79583608
Multi-organ disorder 13.38 12.53 13 61337 2575 79680463
Congestive hepatopathy 13.38 12.53 17 61333 4530 79678508
Injection site pruritus 13.31 12.53 8 61342 42275 79640763
Intentional device misuse 13.27 12.53 8 61342 777 79682261
Pancytopenia 13.27 12.53 74 61276 165671 79517367
Thrombosis 13.26 12.53 28 61322 84072 79598966
Therapeutic product effect incomplete 13.19 12.53 60 61290 141585 79541453
Pulse absent 13.17 12.53 26 61324 10077 79672961
Rash erythematous 13.16 12.53 15 61335 57754 79625284
Victim of homicide 13.13 12.53 5 61345 173 79682865
Cardiac disorder 12.99 12.53 19 61331 65738 79617300
Psychomotor skills impaired 12.97 12.53 18 61332 5219 79677819
Lipid metabolism disorder 12.91 12.53 6 61344 343 79682695
Renal failure 12.89 12.53 96 61254 200872 79482166
Pericardial effusion 12.89 12.53 10 61340 46227 79636811
Brachial artery entrapment syndrome 12.86 12.53 4 61346 74 79682964
Weight decreased 12.86 12.53 194 61156 355004 79328034
Type 2 diabetes mellitus 12.83 12.53 15 61335 57107 79625931
Dyspepsia 12.71 12.53 42 61308 108645 79574393
Menstruation normal 12.66 12.53 4 61346 78 79682960
Presyncope 12.60 12.53 8 61342 41046 79641992
Haematuria 12.54 12.53 21 61329 68815 79614223
Throat irritation 12.54 12.53 8 61342 40938 79642100

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 1033.48 86.42 509 839 1610 86834
Foetal exposure during pregnancy 144.46 86.42 440 908 12401 76043

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




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 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
D(3) dopamine receptor GPCR Ki 5.68 CHEMBL
D(4) dopamine receptor GPCR Ki 4.58 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 0054-0709 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 0054-0710 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 0054-3553 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 0054-3555 SOLUTION 5 mg ORAL ANDA 30 sections
Methadone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-3556 SOLUTION 10 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 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
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 0406-2540 TABLET 40 mg ORAL ANDA 34 sections
Methadone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0406-4123 CONCENTRATE 10 mg ORAL ANDA 40 sections