All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
	1728	76-99-3

Description:

Molecule

Description

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:

Dose	Unit	Route
25	mg	O
25	mg	P

ADMET properties:

Property	Value	Reference
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:

Date	Agency	Company	Orphan
Aug. 13, 1947	FDA	ROXANE

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (acidic/basic)
pKa1	8.55	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Mu-type opioid receptor	GPCR	P35372	OPRM_HUMAN	AGONIST	Ki	8.78		WOMBAT-PK	CHEMBL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	5.01		CHEMBL
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	5.68		CHEMBL
D(4) dopamine receptor	GPCR	P21917	DRD4_HUMAN		Ki	4.58		CHEMBL
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN		IC50	6.29		CHEMBL
Glutamate receptor ionotropic, NMDA 3A	Ion channel	Q8TCU5	NMD3A_HUMAN					WOMBAT-PK
Neuronal acetylcholine receptor subunit alpha-10	Ion channel	Q9GZZ6	ACH10_HUMAN					WOMBAT-PK
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN		IC50	5.96		CHEMBL
Opioid receptor	GPCR		OPRD_RAT OPRM_RAT OPRK_RAT SGMR1_RAT		IC50	7.29		CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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