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

Stem definition	Drug id	CAS RN
	1672	73-31-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: melatonin melatol melatonine circadin	A biogenic amine that is found in animals and plants. In mammals, melatonin is produced by the PINEAL GLAND. Its secretion increases in darkness and decreases during exposure to light. Melatonin is implicated in the regulation of SLEEP, mood, and REPRODUCTION. Melatonin is also an effective antioxidant. Molecular weight: 232.28 Formula: C13H16N2O2 CLOGP: 1.03 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 54.12 ALOGS: -3.21 ROTB: 4

Molecule

Description

Molfile Inchi Smiles

Synonyms:

melatonin
melatol
melatonine
circadin

A biogenic amine that is found in animals and plants. In mammals, melatonin is produced by the PINEAL GLAND. Its secretion increases in darkness and decreases during exposure to light. Melatonin is implicated in the regulation of SLEEP, mood, and REPRODUCTION. Melatonin is also an effective antioxidant.

Molecular weight: 232.28
Formula: C13H16N2O2
CLOGP: 1.03
LIPINSKI: 0
HAC: 4
HDO: 2
TPSA: 54.12
ALOGS: -3.21
ROTB: 4

Drug dosage:

Dose	Unit	Route
2	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.10 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.36 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	12 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	1.10 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	16.50 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.39 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.10 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company
March 25, 2020	PMDA	Nobelpharma Co., Ltd
None	FDA
June 29, 2007	EMA	RAD NEURIM PHARMACEUTICALS EEC SARL

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
Intentional self-injury	457.98	10.89	266	42138	24726	56224937
Intentional overdose	342.04	10.89	333	42071	67784	56181879
Pneumonia aspiration	247.52	10.89	201	42203	32210	56217453
Somnolence	203.76	10.89	407	41997	163006	56086657
Coma	162.15	10.89	212	42192	59443	56190220
Gastrooesophageal reflux disease	161.62	10.89	252	42152	83005	56166658
Rheumatoid arthritis	134.67	10.89	60	42344	382544	55867119
Insomnia	95.85	10.89	340	42064	191520	56058143
Synovitis	91.90	10.89	8	42396	161297	56088366
Glossodynia	88.40	10.89	7	42397	152451	56097212
Maternal exposure during pregnancy	85.65	10.89	19	42385	189534	56060129
Systemic lupus erythematosus	83.51	10.89	17	42387	180061	56069602
Treatment failure	73.20	10.89	19	42385	170373	56079290
Joint swelling	66.69	10.89	72	42332	289728	55959935
Arthropathy	64.89	10.89	35	42369	200240	56049423
Wound	64.56	10.89	13	42391	138791	56110872
Drug intolerance	60.69	10.89	66	42338	264752	55984911
Drug ineffective	57.85	10.89	431	41973	918558	55331105
Discomfort	56.83	10.89	18	42386	141743	56107920
Desmoplastic small round cell tumour	53.94	10.89	15	42389	188	56249475
Swelling	50.38	10.89	64	42340	239707	56009956
Cestode infection	48.81	10.89	15	42389	272	56249391
Exposure during pregnancy	48.45	10.89	21	42383	136321	56113342
Disturbance in attention	45.25	10.89	85	42319	32455	56217208
Therapeutic product effect decreased	42.50	10.89	39	42365	169413	56080250
Drug hypersensitivity	41.54	10.89	91	42313	275114	55974549
Helicobacter infection	40.73	10.89	4	42400	73264	56176399
General physical health deterioration	40.46	10.89	41	42363	169969	56079694
Suicidal ideation	39.40	10.89	114	42290	57628	56192035
Premenstrual syndrome	39.31	10.89	16	42388	676	56248987
Constipation	38.94	10.89	273	42131	201670	56047993
Feeling abnormal	38.80	10.89	201	42203	133401	56116262
Onychoclasis	37.14	10.89	32	42372	5553	56244110
Lip pruritus	36.82	10.89	16	42388	797	56248866
Alopecia	36.57	10.89	107	42297	293351	55956312
Hallucination	36.43	10.89	100	42304	49049	56200614
Magnesium deficiency	35.92	10.89	14	42390	527	56249136
Seizure	34.11	10.89	185	42219	124934	56124729
Anxiety	33.71	10.89	255	42149	192917	56056746
Lichen sclerosus	33.11	10.89	16	42388	1020	56248643
Menstruation delayed	32.85	10.89	18	42386	1492	56248171
Aplastic anaemia	32.82	10.89	37	42367	8891	56240772
Fatigue	32.69	10.89	800	41604	787752	55461911
Tachycardia	32.63	10.89	162	42242	105714	56143949
Polymenorrhoea	31.49	10.89	16	42388	1137	56248526
Hepatic enzyme increased	30.81	10.89	51	42353	171333	56078330
Irritability	30.16	10.89	68	42336	29520	56220143
Restless legs syndrome	29.69	10.89	49	42355	16898	56232765
Clostridium test positive	29.11	10.89	20	42384	2485	56247178
Muscle injury	28.83	10.89	3	42401	52497	56197166
Derailment	28.58	10.89	7	42397	51	56249612
Abdominal discomfort	27.81	10.89	111	42293	277163	55972500
Choanal stenosis	26.94	10.89	6	42398	27	56249636
Infusion related reaction	26.88	10.89	75	42329	208856	56040807
Depression	26.65	10.89	229	42175	179888	56069775
Tremor	26.51	10.89	169	42235	120920	56128743
Sleep disorder	26.40	10.89	111	42293	67552	56182111
Electrocardiogram PR prolongation	26.14	10.89	12	42392	681	56248982
Body temperature fluctuation	25.01	10.89	17	42387	2075	56247588
Vision blurred	24.91	10.89	126	42278	82817	56166846
Abnormal dreams	22.71	10.89	32	42372	9617	56240046
Staphylococcal scalded skin syndrome	22.62	10.89	7	42397	130	56249533
Neuralgia	22.55	10.89	53	42351	23642	56226021
Sleep apnoea syndrome	22.35	10.89	56	42348	26005	56223658
Metastases to peritoneum	21.59	10.89	18	42386	2986	56246677
Infection	20.79	10.89	79	42325	200127	56049536
Helplessness	20.79	10.89	8	42396	291	56249372
Hypersensitivity	20.74	10.89	111	42293	256297	55993366
Restlessness	20.61	10.89	55	42349	26531	56223132
Arthralgia	20.46	10.89	261	42143	501408	55748255
Creatinine urine decreased	20.45	10.89	7	42397	181	56249482
Suicide attempt	20.36	10.89	92	42312	57744	56191919
Tri-iodothyronine free decreased	20.28	10.89	8	42396	311	56249352
Rabbit syndrome	20.16	10.89	8	42396	316	56249347
Anticonvulsant drug level decreased	20.11	10.89	12	42392	1169	56248494
Product dose omission issue	20.00	10.89	239	42165	204514	56045149
Infusion site pruritus	19.54	10.89	21	42383	4786	56244877
Impaired healing	19.46	10.89	22	42382	86819	56162844
Akathisia	19.34	10.89	28	42376	8624	56241039
Tic	19.30	10.89	12	42392	1259	56248404
Lower respiratory tract infection	18.96	10.89	36	42368	114758	56134905
Urine leukocyte esterase positive	18.95	10.89	17	42387	3111	56246552
Agitation	18.89	10.89	88	42316	55948	56193715
Infusion site scar	18.79	10.89	8	42396	379	56249284
Cognitive disorder	18.70	10.89	80	42324	49053	56200610
Memory impairment	18.44	10.89	120	42284	86437	56163226
Angiokeratoma	18.31	10.89	6	42398	135	56249528
Underdose	18.26	10.89	49	42355	23708	56225955
Aorta hypoplasia	18.15	10.89	6	42398	139	56249524
Abnormal behaviour	17.84	10.89	44	42360	20228	56229435
Parasitic gastroenteritis	17.79	10.89	4	42400	19	56249644
Respiratory syncytial virus infection	17.35	10.89	21	42383	5440	56244223
Sinus bradycardia	17.06	10.89	34	42370	13552	56236111
Interstitial lung disease	17.00	10.89	11	42393	57052	56192611
Type 2 diabetes mellitus	16.98	10.89	7	42397	46855	56202808
Irritable bowel syndrome	16.86	10.89	16	42388	68442	56181221
Infusion site rash	16.84	10.89	12	42392	1580	56248083
Protrusion tongue	16.70	10.89	7	42397	319	56249344
Small intestine ulcer	16.45	10.89	7	42397	331	56249332
Convulsive threshold lowered	16.24	10.89	7	42397	342	56249321
Fall	16.01	10.89	367	42037	357143	55892520
False positive investigation result	15.94	10.89	8	42396	554	56249109
Tumour marker abnormal	15.94	10.89	7	42397	358	56249305
Red blood cell sedimentation rate increased	15.87	10.89	4	42400	36619	56213044
Nightmare	15.32	10.89	37	42367	16789	56232874
Coagulation factor V level increased	15.28	10.89	3	42401	6	56249657
Attention deficit hyperactivity disorder	15.25	10.89	14	42390	2640	56247023
Pre-existing condition improved	15.18	10.89	23	42381	7375	56242288
Diarrhoea	14.95	10.89	605	41799	637902	55611761
Gingival pain	14.76	10.89	21	42383	6367	56243296
Vascular stent thrombosis	14.73	10.89	9	42395	915	56248748
Multiple organ dysfunction syndrome	14.63	10.89	11	42393	52759	56196904
Rhabdomyolysis	14.55	10.89	65	42339	40593	56209070
Hepatic function abnormal	14.55	10.89	4	42400	34554	56215109
Product confusion	14.42	10.89	3	42401	9	56249654
Skin burning sensation	14.33	10.89	28	42376	11003	56238660
Mental status changes	14.22	10.89	61	42343	37440	56212223
COVID-19	14.16	10.89	101	42303	74957	56174706
Infusion site swelling	14.00	10.89	23	42381	7898	56241765
Therapeutic response unexpected	13.96	10.89	36	42368	17008	56232655
Lethargy	13.96	10.89	76	42328	51365	56198298
Poisoning deliberate	13.83	10.89	26	42378	9927	56239736
Acute respiratory failure	13.81	10.89	53	42351	30941	56218722
Illness	13.76	10.89	57	42347	34454	56215209
Neutrophil count increased	13.72	10.89	33	42371	14932	56234731
Sleep terror	13.71	10.89	8	42396	748	56248915
Band sensation	13.60	10.89	8	42396	759	56248904
C-reactive protein increased	13.59	10.89	24	42380	78660	56171003
Pregnancy	13.58	10.89	4	42400	33029	56216634
Snoring	13.44	10.89	15	42389	3566	56246097
Lactose intolerance	13.27	10.89	13	42391	2659	56247004
Muscle spasms	13.25	10.89	160	42244	137211	56112452
Tracheo-oesophageal fistula	13.15	10.89	7	42397	548	56249115
Myocardial infarction	12.95	10.89	32	42372	92838	56156825
Infusion site warmth	12.94	10.89	10	42394	1490	56248173
Thyroid cyst	12.88	10.89	7	42397	571	56249092
Psychomotor hyperactivity	12.85	10.89	25	42379	9795	56239868
Basophil count increased	12.82	10.89	8	42396	845	56248818
Urine ketone body present	12.62	10.89	12	42392	2365	56247298
Liver injury	12.56	10.89	8	42396	41840	56207823
Renal failure	12.53	10.89	42	42362	110458	56139205
Depressed level of consciousness	12.48	10.89	79	42325	56354	56193309
Hypoaesthesia oral	12.47	10.89	27	42377	11404	56238259
Metastases to lymph nodes	12.38	10.89	21	42383	7402	56242261
Hypopnoea	12.33	10.89	12	42392	2433	56247230
Activation syndrome	12.29	10.89	5	42399	211	56249452
Tinnitus	12.28	10.89	50	42354	29992	56219671
Infusion site pain	12.25	10.89	30	42374	13732	56235931
Balance disorder	12.21	10.89	99	42305	76421	56173242
Infective pulmonary exacerbation of cystic fibrosis	12.21	10.89	22	42382	8135	56241528
Confusional arousal	12.17	10.89	4	42400	91	56249572
Oral cavity fistula	12.12	10.89	7	42397	642	56249021
Stupor	12.04	10.89	15	42389	4003	56245660
Peripheral swelling	11.96	10.89	116	42288	234610	56015053
Nasal congestion	11.91	10.89	78	42326	56292	56193371
Water intoxication	11.88	10.89	6	42398	421	56249242
Hypersomnia	11.86	10.89	33	42371	16308	56233355
Hyporesponsive to stimuli	11.67	10.89	8	42396	990	56248673
Alcoholic pancreatitis	11.59	10.89	3	42401	28	56249635
Headache	11.56	10.89	523	41881	558521	55691142
Crying	11.54	10.89	39	42365	21401	56228262
Pulmonary fibrosis	11.53	10.89	4	42400	29754	56219909
Medication error	11.51	10.89	9	42395	42326	56207337
Sinus disorder	11.41	10.89	38	42366	20696	56228967
Dizziness	11.37	10.89	367	42037	375773	55873890
Weight decreased	11.35	10.89	249	42155	240465	56009198
Complement factor C4 decreased	11.16	10.89	5	42399	268	56249395
Paradoxical drug reaction	11.03	10.89	14	42390	3806	56245857
Meningitis aseptic	10.97	10.89	15	42389	4384	56245279
Infusion site discomfort	10.96	10.89	8	42396	1094	56248569
Myocarditis	10.92	10.89	22	42382	8836	56240827
Autism spectrum disorder	10.90	10.89	7	42397	777	56248886

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
Appendicolith	245.85	11.97	113	27209	5618	31664404
Appendicitis	192.22	11.97	121	27201	11344	31658678
Stress	131.10	11.97	133	27189	24808	31645214
Intentional self-injury	128.10	11.97	100	27222	13215	31656807
Cardiogenic shock	126.08	11.97	124	27198	22284	31647738
Abdominal distension	107.70	11.97	172	27150	50512	31619510
Congenital hiatus hernia	93.05	11.97	30	27292	556	31669466
Victim of child abuse	87.41	11.97	32	27290	880	31669142
Constipation	82.97	11.97	265	27057	123726	31546296
Hallucination	71.82	11.97	137	27185	46273	31623749
Ventricular fibrillation	70.34	11.97	84	27238	18764	31651258
Ascites	64.61	11.97	122	27200	40891	31629131
Multiple organ dysfunction syndrome	64.28	11.97	165	27157	68038	31601984
Parasomnia	58.88	11.97	19	27303	353	31669669
Hyponatraemia	57.03	11.97	166	27156	73633	31596389
Agitation	53.05	11.97	133	27189	54036	31615986
Aggression	52.73	11.97	106	27216	37185	31632837
Intentional overdose	50.77	11.97	111	27211	41278	31628744
Insomnia	50.53	11.97	188	27134	94648	31575374
Respiratory depression	49.80	11.97	62	27260	14448	31655574
Somnolence	47.15	11.97	190	27132	99255	31570767
Blood phosphorus increased	46.02	11.97	35	27287	4447	31665575
Epidural lipomatosis	45.07	11.97	19	27303	765	31669257
Aplastic anaemia	41.06	11.97	45	27277	9158	31660864
Product prescribing error	40.77	11.97	66	27256	19576	31650446
Breath sounds abnormal	39.50	11.97	36	27286	5876	31664146
Fall	38.93	11.97	284	27038	185805	31484217
Choreoathetosis	37.01	11.97	18	27304	1015	31669007
Dystonia	35.58	11.97	44	27278	10181	31659841
Abnormal sleep-related event	32.42	11.97	13	27309	460	31669562
Malignant melanoma in situ	32.17	11.97	18	27304	1356	31668666
Child abuse	31.70	11.97	12	27310	363	31669659
Drug dependence	31.68	11.97	64	27258	22515	31647507
Product administered to patient of inappropriate age	30.86	11.97	23	27299	2834	31667188
Juvenile idiopathic arthritis	30.82	11.97	19	27303	1714	31668308
Vomiting	29.17	11.97	308	27014	223665	31446357
Confusional state	28.71	11.97	205	27117	133129	31536893
Bronchiectasis	28.63	11.97	34	27288	7546	31662476
Electrocardiogram QT interval abnormal	28.18	11.97	8	27314	94	31669928
Dyskinesia	27.84	11.97	58	27264	20852	31649170
Extrapyramidal disorder	27.81	11.97	42	27280	11736	31658286
Interstitial lung disease	26.30	11.97	10	27312	61393	31608629
Suicidal behaviour	26.23	11.97	16	27306	1416	31668606
General physical health deterioration	25.34	11.97	176	27146	113259	31556763
Paradoxical drug reaction	24.80	11.97	21	27301	3108	31666914
Psychomotor hyperactivity	24.64	11.97	34	27288	8753	31661269
Sepsis	24.20	11.97	218	27104	151711	31518311
Abdominal pain	23.53	11.97	210	27112	145742	31524280
Off label use	22.89	11.97	423	26899	346851	31323171
Abnormal behaviour	22.78	11.97	58	27264	23770	31646252
Hallucinations, mixed	22.42	11.97	18	27304	2474	31667548
Myocardial infarction	22.10	11.97	40	27282	113414	31556608
Suicidal ideation	21.76	11.97	75	27247	36331	31633691
Hospice care	21.04	11.97	25	27297	5551	31664471
Anaemia	20.80	11.97	104	27218	213418	31456604
Hepatic function abnormal	20.74	11.97	5	27317	41217	31628805
Mixed dementia	20.33	11.97	8	27314	269	31669753
Delirium	20.28	11.97	80	27242	41341	31628681
Full blood count abnormal	20.21	11.97	44	27278	16303	31653719
Bladder dilatation	19.49	11.97	13	27309	1343	31668679
Tardive dyskinesia	19.47	11.97	24	27298	5535	31664487
Gastric hypomotility	19.20	11.97	6	27316	100	31669922
Drooling	19.04	11.97	18	27304	3077	31666945
Poor quality sleep	19.01	11.97	28	27294	7650	31662372
Behaviour disorder	18.95	11.97	21	27301	4326	31665696
Mental status changes	18.86	11.97	71	27251	35897	31634125
Nausea	18.86	11.97	371	26951	307576	31362446
Salivary hypersecretion	18.70	11.97	28	27294	7764	31662258
Subacute cutaneous lupus erythematosus	18.68	11.97	11	27311	913	31669109
Rheumatoid arthritis	18.54	11.97	9	27313	47800	31622222
Stoma site discharge	18.32	11.97	11	27311	946	31669076
Seizure	17.88	11.97	147	27175	99621	31570401
Acute myocardial infarction	17.63	11.97	11	27311	50812	31619210
Muscle rigidity	17.54	11.97	31	27291	9866	31660156
Device kink	17.52	11.97	8	27314	391	31669631
Restlessness	17.49	11.97	52	27270	23309	31646713
Acute kidney injury	17.32	11.97	156	27166	279558	31390464
Hyperkalaemia	17.24	11.97	18	27304	64333	31605689
Gallbladder enlargement	17.20	11.97	11	27311	1058	31668964
Pleurothotonus	17.07	11.97	11	27311	1072	31668950
Multiple drug therapy	17.00	11.97	8	27314	419	31669603
Opisthotonus	16.40	11.97	8	27314	454	31669568
Hypersomnia	16.17	11.97	32	27290	11087	31658935
Viral diarrhoea	16.15	11.97	6	27316	172	31669850
Disease risk factor	16.10	11.97	3	27319	3	31670019
Abscess intestinal	15.84	11.97	12	27310	1515	31668507
Renal failure	15.78	11.97	54	27268	123276	31546746
Renal impairment	15.45	11.97	32	27290	86317	31583705
Serotonin syndrome	15.22	11.97	43	27279	18730	31651292
Respiratory alkalosis	15.19	11.97	12	27310	1611	31668411
Dementia	14.97	11.97	33	27289	12327	31657695
Speech disorder	14.58	11.97	50	27272	24151	31645871
Intentional product misuse	14.49	11.97	68	27254	37883	31632139
Device issue	14.30	11.97	26	27296	8458	31661564
Arrhythmia supraventricular	14.15	11.97	10	27312	1135	31668887
Parkinsonian rest tremor	13.99	11.97	5	27317	128	31669894
Embedded device	13.88	11.97	6	27316	257	31669765
Progesterone increased	13.78	11.97	3	27319	10	31670012
Benign prostatic hyperplasia	13.65	11.97	33	27289	13092	31656930
Glycogen storage disease type VIII	13.35	11.97	3	27319	12	31670010
Middle insomnia	13.35	11.97	21	27301	6078	31663944
Joint injury	13.18	11.97	24	27298	7817	31662205
Growth hormone-producing pituitary tumour	13.01	11.97	4	27318	63	31669959
Stoma site infection	12.89	11.97	8	27314	730	31669292
Camptocormia	12.88	11.97	5	27317	162	31669860
Cardiac failure	12.87	11.97	35	27287	85918	31584104
Micturition urgency	12.84	11.97	20	27302	5740	31664282
Acanthosis nigricans	12.74	11.97	5	27317	167	31669855
Hallucination, visual	12.63	11.97	36	27286	15758	31654264
C-reactive protein increased	12.59	11.97	14	27308	48636	31621386
Leukopenia	12.54	11.97	19	27303	57809	31612213
Eye movement disorder	12.45	11.97	16	27306	3845	31666177
Blood growth hormone increased	12.44	11.97	6	27316	332	31669690
Shunt malfunction	12.34	11.97	5	27317	182	31669840
Tremor	12.31	11.97	110	27212	76310	31593712
Product dose omission issue	12.23	11.97	142	27180	105444	31564578
Cardio-respiratory arrest	12.20	11.97	16	27306	51710	31618312
Haematuria traumatic	12.03	11.97	5	27317	194	31669828

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
Intentional self-injury	363.28	10.63	258	57326	31392	70839468
Appendicolith	249.99	10.63	112	57472	5568	70865292
Intentional overdose	219.87	10.63	331	57253	98104	70772756
Somnolence	197.60	10.63	497	57087	215109	70655751
Appendicitis	161.69	10.63	123	57461	16610	70854250
Pneumonia aspiration	136.94	10.63	208	57376	62081	70808779
Gastrooesophageal reflux disease	128.00	10.63	249	57335	90590	70780270
Rheumatoid arthritis	100.42	10.63	56	57528	291749	70579111
Coma	99.37	10.63	226	57358	91618	70779242
Congenital hiatus hernia	91.67	10.63	29	57555	537	70870323
Cardiogenic shock	91.00	10.63	129	57455	36178	70834682
Constipation	88.88	10.63	423	57161	252015	70618845
Victim of child abuse	88.39	10.63	32	57552	906	70869954
Hallucination	87.36	10.63	192	57392	76068	70794792
Insomnia	84.08	10.63	375	57209	217431	70653429
Synovitis	79.05	10.63	7	57577	129221	70741639
Aplastic anaemia	77.32	10.63	81	57503	16635	70854225
Ascites	77.29	10.63	170	57414	67377	70803483
Stress	76.58	10.63	170	57414	67796	70803064
Abdominal distension	63.30	10.63	208	57376	104461	70766399
Agitation	61.42	10.63	191	57393	93184	70777676
Joint swelling	60.32	10.63	70	57514	253141	70617719
Contraindicated product administered	58.89	10.63	18	57566	134594	70736266
Treatment failure	58.33	10.63	22	57562	144120	70726740
Pericarditis	56.41	10.63	3	57581	84702	70786158
Ventricular fibrillation	54.62	10.63	87	57497	27024	70843836
Aggression	53.24	10.63	120	57464	48326	70822534
Desmoplastic small round cell tumour	50.60	10.63	15	57569	221	70870639
Parasomnia	49.67	10.63	18	57566	511	70870349
Maternal exposure during pregnancy	49.43	10.63	16	57568	115329	70755531
Cestode infection	48.18	10.63	15	57569	263	70870597
Systemic lupus erythematosus	43.90	10.63	14	57570	101888	70768972
Glossodynia	42.76	10.63	9	57575	86478	70784382
Suicidal ideation	42.69	10.63	139	57445	69457	70801403
Epidural lipomatosis	42.52	10.63	19	57565	938	70869922
Disturbance in attention	42.48	10.63	102	57482	42792	70828068
Wound	41.77	10.63	14	57570	98718	70772142
Premenstrual syndrome	41.68	10.63	16	57568	535	70870325
Seizure	41.58	10.63	267	57317	177695	70693165
Drug dependence	40.51	10.63	92	57492	37229	70833631
Irritability	40.14	10.63	93	57491	38132	70832728
Exposure during pregnancy	39.70	10.63	11	57573	87706	70783154
Drug intolerance	39.57	10.63	77	57507	225610	70645250
Interstitial lung disease	39.09	10.63	18	57566	104667	70766193
Drug hypersensitivity	39.08	10.63	98	57486	262361	70608499
Hepatic function abnormal	38.22	10.63	5	57579	67991	70802869
Discomfort	36.56	10.63	20	57564	105416	70765444
Lip pruritus	36.31	10.63	16	57568	764	70870096
Arthropathy	36.23	10.63	41	57543	150016	70720844
Fall	36.16	10.63	533	57051	443563	70427297
Respiratory depression	34.86	10.63	68	57516	24763	70846097
Hyponatraemia	34.85	10.63	236	57348	159851	70711009
Dystonia	34.01	10.63	59	57525	19647	70851213
Blood phosphorus increased	33.46	10.63	34	57550	6736	70864124
Lichen sclerosus	33.44	10.63	16	57568	925	70869935
Mental status changes	33.41	10.63	120	57464	62981	70807879
Polymenorrhoea	33.29	10.63	16	57568	934	70869926
Child abuse	32.46	10.63	12	57572	361	70870499
Multiple organ dysfunction syndrome	31.91	10.63	173	57411	108342	70762518
Abnormal sleep-related event	31.58	10.63	15	57569	853	70870007
Clostridium test positive	30.94	10.63	28	57556	4808	70866052
Swelling	30.78	10.63	67	57517	188472	70682388
Magnesium deficiency	30.67	10.63	13	57571	564	70870296
Abnormal behaviour	30.64	10.63	79	57505	34630	70836230
Paradoxical drug reaction	30.41	10.63	32	57552	6604	70864256
Restlessness	30.34	10.63	89	57495	42039	70828821
Tremor	30.13	10.63	223	57361	155401	70715459
Behaviour disorder	29.89	10.63	29	57555	5435	70865425
Drug ineffective	29.82	10.63	561	57023	939191	69931669
Myocardial infarction	29.70	10.63	59	57525	171586	70699274
Menstruation delayed	29.40	10.63	16	57568	1213	70869647
Extrapyramidal disorder	29.34	10.63	57	57527	20693	70850167
Hypersomnia	29.31	10.63	57	57527	20707	70850153
Anxiety	29.11	10.63	290	57294	220040	70650820
Choreoathetosis	28.87	10.63	17	57567	1499	70869361
Product prescribing error	28.74	10.63	83	57501	38869	70831991
Onychoclasis	28.30	10.63	27	57557	4957	70865903
Product administered to patient of inappropriate age	27.05	10.63	26	57558	4817	70866043
Feeling abnormal	27.01	10.63	203	57381	142116	70728744
Malignant melanoma in situ	26.69	10.63	18	57566	2011	70868849
Arthralgia	26.52	10.63	271	57313	503119	70367741
Suicidal behaviour	26.34	10.63	21	57563	3035	70867825
Derailment	26.18	10.63	7	57577	69	70870791
Akathisia	25.52	10.63	40	57544	12253	70858607
Helicobacter infection	25.14	10.63	7	57577	55649	70815211
Restless legs syndrome	24.10	10.63	49	57535	18379	70852481
Therapeutic product effect decreased	24.02	10.63	50	57534	142968	70727892
Alopecia	23.80	10.63	82	57502	198408	70672452
Product dose omission issue	23.50	10.63	275	57309	217193	70653667
Delirium	23.33	10.63	121	57463	74493	70796367
Fatigue	23.25	10.63	852	56732	823467	70047393
Sleep disorder	23.03	10.63	115	57469	69757	70801103
Full blood count abnormal	22.91	10.63	70	57514	33808	70837052
Psychomotor hyperactivity	22.56	10.63	43	57541	15390	70855470
Tachycardia	22.56	10.63	212	57372	158334	70712526
Sepsis	22.47	10.63	300	57284	244245	70626615
Hypersensitivity	22.44	10.63	103	57481	229709	70641151
Rabbit syndrome	22.26	10.63	9	57575	346	70870514
Oculogyric crisis	22.11	10.63	18	57566	2680	70868180
Tic	21.90	10.63	18	57566	2715	70868145
Renal failure	21.41	10.63	80	57504	188990	70681870
Red blood cell sedimentation rate increased	21.34	10.63	3	57581	38639	70832221
Cognitive disorder	21.28	10.63	102	57482	60854	70810006
Type 2 diabetes mellitus	20.95	10.63	5	57579	44075	70826785
C-reactive protein increased	20.87	10.63	36	57548	110481	70760379
Mixed dementia	20.44	10.63	8	57576	282	70870578
Autism spectrum disorder	20.38	10.63	12	57572	1058	70869802
Confusional state	20.30	10.63	334	57250	284064	70586796
Infusion site scar	20.05	10.63	8	57576	297	70870563
Acute respiratory failure	19.61	10.63	91	57493	53574	70817286
Infusion related reaction	19.60	10.63	88	57496	197446	70673414
On and off phenomenon	19.55	10.63	17	57567	2769	70868091
Inflammation	19.52	10.63	21	57563	78644	70792216
Breath sounds abnormal	19.51	10.63	37	57547	13194	70857666
Crying	19.49	10.63	49	57535	21150	70849710
Stoma site discharge	19.25	10.63	14	57570	1765	70869095
Abdominal pain	19.22	10.63	387	57197	341740	70529120
Dyskinesia	19.15	10.63	75	57509	40999	70829861
Benign prostatic hyperplasia	18.99	10.63	32	57552	10411	70860449
Hospice care	18.87	10.63	28	57556	8177	70862683
Influenza B virus test positive	18.75	10.63	8	57576	353	70870507
Helplessness	18.62	10.63	8	57576	359	70870501
Tri-iodothyronine free decreased	18.50	10.63	8	57576	365	70870495
Poisoning deliberate	18.45	10.63	42	57542	17018	70853842
Bladder dilatation	18.31	10.63	14	57570	1903	70868957
Underdose	18.29	10.63	59	57525	29324	70841536
Eye movement disorder	18.00	10.63	26	57558	7414	70863446
Body temperature fluctuation	17.82	10.63	18	57566	3541	70867319
Antipsychotic drug level increased	17.74	10.63	22	57562	5418	70865442
Intentional product misuse	17.70	10.63	118	57466	79477	70791383
Salivary hypersecretion	17.66	10.63	35	57549	12890	70857970
Infusion site pruritus	17.37	10.63	17	57567	3220	70867640
Serotonin syndrome	17.34	10.63	74	57510	42040	70828820
Abnormal dreams	17.33	10.63	31	57553	10572	70860288
Lower respiratory tract infection	17.26	10.63	41	57543	111872	70758988
Tumour marker abnormal	17.20	10.63	7	57577	274	70870586
Electrocardiogram PR prolongation	17.16	10.63	12	57572	1422	70869438
Psychotic disorder	16.90	10.63	68	57516	37633	70833227
Renal impairment	16.89	10.63	60	57524	143877	70726983
Anaphylactic shock	16.86	10.63	3	57581	32487	70838373
Hepatic enzyme increased	16.76	10.63	68	57516	156922	70713938
Metastases to peritoneum	16.76	10.63	18	57566	3801	70867059
Vision blurred	16.64	10.63	133	57451	94851	70776009
Electrocardiogram QT interval abnormal	16.62	10.63	7	57577	299	70870561
Attention deficit hyperactivity disorder	16.62	10.63	16	57568	2971	70867889
Anaphylactic reaction	16.49	10.63	22	57562	74952	70795908
Gallbladder enlargement	16.49	10.63	12	57572	1514	70869346
Memory impairment	16.38	10.63	130	57454	92511	70778349
Cytomegalovirus infection	16.19	10.63	6	57578	39752	70831108
Impaired healing	16.18	10.63	22	57562	74352	70796508
Drug reaction with eosinophilia and systemic symptoms	16.12	10.63	14	57570	57999	70812861
Dysarthria	16.11	10.63	96	57488	62217	70808643
Hallucination, visual	15.70	10.63	56	57528	29281	70841579
Neuralgia	15.65	10.63	55	57529	28548	70842312
Infusion site rash	15.60	10.63	11	57573	1321	70869539
Gingival pain	15.46	10.63	23	57561	6734	70864126
Nausea	15.44	10.63	842	56742	851246	70019614
Acute kidney injury	15.38	10.63	282	57302	474342	70396518
Psoriatic arthropathy	15.30	10.63	18	57566	64753	70806107
Hepatitis	15.23	10.63	11	57573	49969	70820891
Angioedema	15.22	10.63	19	57565	66591	70804269
Nightmare	15.19	10.63	46	57538	22110	70848750
Angiokeratoma	15.13	10.63	6	57578	219	70870641
Juvenile idiopathic arthritis	15.11	10.63	21	57563	5779	70865081
Adhesive tape use	15.06	10.63	3	57581	6	70870854
Mood altered	15.06	10.63	38	57546	16437	70854423
Rash	14.84	10.63	309	57275	510253	70360607
Protrusion tongue	14.74	10.63	7	57577	398	70870462
Unresponsive to stimuli	14.72	10.63	82	57502	51849	70819011
Staphylococcal scalded skin syndrome	14.64	10.63	7	57577	404	70870456
International normalised ratio increased	14.61	10.63	27	57557	80699	70790161
Creatinine urine decreased	14.59	10.63	6	57578	241	70870619
Bronchiectasis	14.58	10.63	37	57547	16060	70854800
Cytokine release syndrome	14.58	10.63	51	57533	26416	70844444
Therapeutic response unexpected	14.57	10.63	40	57544	18191	70852669
Skin burning sensation	14.49	10.63	30	57554	11396	70859464
Hypoxia	14.38	10.63	127	57457	93217	70777643
Infective pulmonary exacerbation of cystic fibrosis	14.35	10.63	31	57553	12127	70858733
False positive investigation result	14.35	10.63	9	57575	889	70869971
Parasitic gastroenteritis	14.32	10.63	4	57580	47	70870813
Vomiting	14.08	10.63	602	56982	592509	70278351
Therapeutic response decreased	14.07	10.63	16	57568	58437	70812423
Gaze palsy	13.99	10.63	14	57570	2724	70868136
Opisthotonus	13.92	10.63	8	57576	674	70870186
Liver disorder	13.61	10.63	18	57566	61550	70809310
Distractibility	13.47	10.63	8	57576	717	70870143
Infection	13.45	10.63	108	57476	210677	70660183
Dissociative disorder	13.37	10.63	7	57577	491	70870369
Respiratory syncytial virus infection	13.31	10.63	23	57561	7632	70863228
Urine ketone body present	13.23	10.63	15	57569	3364	70867496
Suicide attempt	13.20	10.63	110	57474	79400	70791460
Abscess intestinal	13.18	10.63	13	57571	2485	70868375
Glycogen storage disease type VIII	13.16	10.63	3	57581	14	70870846
Drooling	13.15	10.63	19	57565	5417	70865443
Snoring	13.14	10.63	18	57566	4886	70865974
Dementia with Lewy bodies	13.11	10.63	8	57576	753	70870107
Toxic epidermal necrolysis	13.00	10.63	8	57576	39549	70831311
Disease risk factor	12.99	10.63	3	57581	15	70870845
Growth hormone-producing pituitary tumour	12.91	10.63	4	57580	69	70870791
Slow speech	12.68	10.63	12	57572	2180	70868680
Anaemia	12.66	10.63	241	57343	403182	70467678
Acanthosis nigricans	12.65	10.63	5	57579	181	70870679
Gastric hypomotility	12.63	10.63	5	57579	182	70870678
Hepatic failure	12.58	10.63	17	57567	57608	70813252
Viral diarrhoea	12.57	10.63	6	57578	345	70870515
Product confusion	12.53	10.63	3	57581	18	70870842
Viral infection	12.51	10.63	63	57521	38328	70832532
Cardiac failure	12.47	10.63	67	57517	143474	70727386
Micturition urgency	12.40	10.63	28	57556	11286	70859574
Toxicity to various agents	12.40	10.63	227	57357	381945	70488915
Haematuria traumatic	12.37	10.63	5	57579	192	70870668
Anticonvulsant drug level decreased	12.32	10.63	11	57573	1856	70869004
Urine leukocyte esterase positive	12.31	10.63	15	57569	3630	70867230
Infusion site warmth	12.18	10.63	9	57575	1162	70869698
Affect lability	12.13	10.63	26	57558	10120	70860740
Thyroid cyst	11.87	10.63	6	57578	391	70870469
Drug eruption	11.64	10.63	9	57575	39487	70831373
Sudden unexplained death in epilepsy	11.55	10.63	7	57577	651	70870209
COVID-19	11.53	10.63	134	57450	105623	70765237
Liver function test abnormal	11.47	10.63	20	57564	61126	70809734
Neutropenic sepsis	11.45	10.63	3	57581	24827	70846033
Oral cavity fistula	11.29	10.63	7	57577	678	70870182
Infusion site swelling	11.28	10.63	19	57565	6179	70864681
Immune effector cell-associated neurotoxicity syndrome	11.27	10.63	15	57569	3963	70866897
Infusion site discomfort	11.21	10.63	8	57576	979	70869881
Muscle rigidity	11.21	10.63	37	57547	18613	70852247
Small intestine ulcer	11.19	10.63	7	57577	688	70870172
Stoma site infection	11.15	10.63	9	57575	1323	70869537
Hypomagnesaemia	11.13	10.63	10	57574	40754	70830106
Abdominal discomfort	11.09	10.63	116	57468	214542	70656318
Poor quality sleep	11.02	10.63	39	57545	20310	70850550
Shunt malfunction	11.00	10.63	5	57579	257	70870603
Basophil count increased	10.91	10.63	9	57575	1364	70869496
Hypoaesthesia oral	10.86	10.63	28	57556	12272	70858588
Parkinsonian rest tremor	10.82	10.63	5	57579	267	70870593
Camptocormia	10.78	10.63	6	57578	475	70870385
Hypogonadism	10.78	10.63	9	57575	1387	70869473
Pregnancy	10.72	10.63	3	57581	23778	70847082
Activation syndrome	10.72	10.63	5	57579	273	70870587
Urinary tract infection	10.69	10.63	271	57313	248498	70622362

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N05CH01	NERVOUS SYSTEM PSYCHOLEPTICS HYPNOTICS AND SEDATIVES Melatonin receptor agonists
MeSH PA	D000975	Antioxidants
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D020011	Protective Agents
CHEBI has role	CHEBI:24621	hormones
CHEBI has role	CHEBI:35488	central nervous system depressants
CHEBI has role	CHEBI:35623	anticonvulsants
CHEBI has role	CHEBI:48578	free radical scavengers
CHEBI has role	CHEBI:50847	Immunologic adjuvant
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
CHEBI has role	CHEBI:176497	geroprotectors

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

Disease	Relation	SNOMED_ID	DOID
Disorders of initiating and maintaining sleep	indication	194437008
Alcoholism	contraindication	7200002
Psoriasis	contraindication	9014002	DOID:8893
Poisoning by digitalis glycoside	contraindication	12876009
Constipation	contraindication	14760008	DOID:2089
Sarcoidosis	contraindication	31541009	DOID:11335
Depressive disorder	contraindication	35489007
Systemic lupus erythematosus	contraindication	55464009	DOID:9074
Schizophrenia	contraindication	58214004	DOID:5419
Hepatic failure	contraindication	59927004
Hypercalcemia	contraindication	66931009	DOID:12678
Poisoning by acetaminophen	contraindication	70273001
Hypercalciuria	contraindication	71938000
Autoimmune disease	contraindication	85828009
Kidney disease	contraindication	90708001	DOID:557
Eosinophilia myalgia syndrome	contraindication	95416007	DOID:998
Kidney stone	contraindication	95570007
Disease of liver	contraindication	235856003	DOID:409

🐶 Veterinary Drug Use

Species	Use	Relation
Mustelids	Acceleration of the fur priming cycle	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
PrimeX	Wildlife Laboratories Inc.	1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.29	acidic
pKa2	13.99	acidic

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])	Bioact source	MoA source
Melatonin receptor type 1B	GPCR	P49286	MTR1B_HUMAN	AGONIST	EC50	9.70	WOMBAT-PK	IUPHAR
Melatonin receptor type 1A	GPCR	P48039	MTR1A_HUMAN	AGONIST	EC50	9.40	WOMBAT-PK	IUPHAR
Nuclear receptor ROR-alpha	Nuclear hormone receptor	P35398	RORA_HUMAN		EC50	9	WOMBAT-PK
Myeloperoxidase	Enzyme	P05164	PERM_HUMAN		IC50	5.52	CHEMBL
Histamine H3 receptor	GPCR	Q9Y5N1	HRH3_HUMAN		Ki	9.30	CHEMBL
Cytochrome P450 1B1	Enzyme	Q16678	CP1B1_HUMAN		Ki	4.85	CHEMBL
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN	ANTAGONIST	Ki	5.20	IUPHAR
Ribosyldihydronicotinamide dehydrogenase [quinone]	Enzyme	P16083	NQO2_HUMAN		Ki	7.56	CHEMBL
Melatonin receptor type 1B	GPCR		MTR1B_CHICK		Ki	9.15	CHEMBL
Melatonin receptor	GPCR		MTR1A_CHICK MTR1C_CHICK MTR1B_CHICK		Ki	9.75	CHEMBL
Melatonin receptor type 1C	GPCR		MTR1C_XENLA		EC50	9.91	CHEMBL

External reference:

ID	Source
4021324	VUID
N0000148757	NUI
4021324	VANDF
C0025219	UMLSCUI
CHEBI:16796	CHEBI
ML1	PDB_CHEM_ID
CHEMBL45	ChEMBL_ID
DB01065	DRUGBANK_ID
D008550	MESH_DESCRIPTOR_UI
896	PUBCHEM_CID
224	IUPHAR_LIGAND_ID
JL5DK93RCL	UNII
6711	RXNORM
5037	MMSL
5609	MMSL
d04058	MMSL
005039	NDDF
116523008	SNOMEDCT_US
41199001	SNOMEDCT_US

Pharmaceutical products:

None