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

Stem definitionDrug idCAS RN
1672 73-31-4

Description:

MoleculeDescription

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:

DoseUnitRoute
2 mg O

ADMET properties:

PropertyValueReference
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 ยตM/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:

DateAgencyCompanyOrphan
None FDA
March 25, 2020 PMDA Nobelpharma Co., Ltd

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
Intentional self-injury 457.07 10.86 261 38931 22851 50543081
Intentional overdose 347.07 10.86 327 38865 62177 50503755
Pneumonia aspiration 237.81 10.86 195 38997 30809 50535123
Somnolence 185.82 10.86 386 38806 154599 50411333
Gastrooesophageal reflux disease 159.81 10.86 243 38949 76185 50489747
Coma 154.60 10.86 205 38987 56674 50509258
Insomnia 73.58 10.86 299 38893 174566 50391366
Desmoplastic small round cell tumour 72.47 10.86 15 39177 42 50565890
Maternal exposure during pregnancy 69.28 10.86 19 39173 159759 50406173
Synovitis 68.16 10.86 8 39184 123857 50442075
Glossodynia 64.75 10.86 7 39185 115562 50450370
Systemic lupus erythematosus 60.44 10.86 17 39175 140605 50425327
Treatment failure 60.36 10.86 16 39176 137621 50428311
Joint swelling 53.34 10.86 67 39125 245219 50320713
Drug ineffective 53.05 10.86 395 38797 818938 49746994
Cestode infection 48.40 10.86 15 39177 272 50565660
Arthropathy 47.50 10.86 32 39160 157874 50408058
Drug intolerance 47.47 10.86 60 39132 219044 50346888
Wound 45.06 10.86 13 39179 105781 50460151
Disturbance in attention 43.66 10.86 83 39109 31103 50534829
Rheumatoid arthritis 43.32 10.86 56 39136 202494 50363438
Discomfort 43.17 10.86 15 39177 108365 50457567
Exposure during pregnancy 41.38 10.86 21 39171 120994 50444938
Premenstrual syndrome 40.78 10.86 16 39176 596 50565336
Onychoclasis 38.38 10.86 32 39160 5164 50560768
Lip pruritus 37.78 10.86 16 39176 727 50565205
Drug hypersensitivity 37.60 10.86 87 39105 250923 50315009
Swelling 37.57 10.86 61 39131 200811 50365121
Hallucination 36.97 10.86 99 39093 46558 50519374
Magnesium deficiency 36.62 10.86 14 39178 486 50565446
Tachycardia 33.82 10.86 160 39032 99603 50466329
Lichen sclerosus 33.46 10.86 16 39176 969 50564963
Menstruation delayed 33.29 10.86 18 39174 1413 50564519
Seizure 32.25 10.86 178 39014 117696 50448236
Suicidal ideation 31.94 10.86 105 39087 55280 50510652
Polymenorrhoea 31.63 10.86 16 39176 1095 50564837
Constipation 31.08 10.86 248 38944 185460 50380472
Restless legs syndrome 31.01 10.86 49 39143 15848 50550084
General physical health deterioration 30.83 10.86 39 39153 142395 50423537
Therapeutic product effect decreased 29.71 10.86 37 39155 136013 50429919
Fatigue 28.94 10.86 734 38458 706867 49859065
Feeling abnormal 28.83 10.86 181 39011 125311 50440621
Irritability 28.50 10.86 66 39126 28360 50537572
Derailment 28.39 10.86 7 39185 51 50565881
Alopecia 27.12 10.86 98 39094 244949 50320983
Anxiety 26.94 10.86 232 38960 177374 50388558
Choanal stenosis 26.78 10.86 6 39186 27 50565905
Electrocardiogram PR prolongation 26.33 10.86 12 39180 651 50565281
Body temperature fluctuation 25.49 10.86 17 39175 1956 50563976
Helicobacter infection 25.45 10.86 4 39188 49698 50516234
Vision blurred 25.11 10.86 124 39068 78523 50487409
Sleep apnoea syndrome 24.57 10.86 56 39136 23812 50542120
Depression 24.00 10.86 214 38978 165209 50400723
Tremor 23.51 10.86 161 39031 114742 50451190
Staphylococcal scalded skin syndrome 22.90 10.86 7 39185 121 50565811
Hepatic enzyme increased 22.72 10.86 45 39147 137335 50428597
Metastases to peritoneum 22.08 10.86 18 39174 2815 50563117
Helplessness 21.60 10.86 8 39184 254 50565678
Infusion related reaction 21.38 10.86 64 39128 169493 50396439
Abnormal dreams 21.26 10.86 31 39161 9346 50556586
Tri-iodothyronine free decreased 20.29 10.86 8 39184 302 50565630
Neuralgia 20.01 10.86 49 39143 21814 50544118
Anticonvulsant drug level decreased 19.90 10.86 12 39180 1159 50564773
Akathisia 19.82 10.86 28 39164 8201 50557731
Memory impairment 19.82 10.86 117 39075 79243 50486689
Suicide attempt 19.78 10.86 86 39106 51646 50514286
Urine leukocyte esterase positive 19.75 10.86 17 39175 2866 50563066
Infusion site scar 19.67 10.86 8 39184 328 50565604
Muscle injury 18.97 10.86 3 39189 37108 50528824
Tumour marker abnormal 18.91 10.86 7 39185 222 50565710
Restlessness 18.52 10.86 52 39140 25121 50540811
Abdominal discomfort 18.23 10.86 105 39087 231536 50334396
Angiokeratoma 18.15 10.86 6 39186 135 50565797
Respiratory syncytial virus infection 18.04 10.86 21 39171 5081 50560851
Aorta hypoplasia 17.98 10.86 6 39186 139 50565793
Abnormal behaviour 17.93 10.86 44 39148 19614 50546318
Parasitic gastroenteritis 17.68 10.86 4 39188 19 50565913
Cognitive disorder 17.37 10.86 74 39118 44049 50521883
Interstitial lung disease 17.04 10.86 10 39182 53166 50512766
Infusion site pruritus 17.01 10.86 18 39174 3919 50562013
Tic 16.97 10.86 11 39181 1206 50564726
Creatinine urine decreased 16.88 10.86 6 39186 169 50565763
Renal failure 16.72 10.86 36 39156 106597 50459335
Infection 16.69 10.86 73 39119 172881 50393051
Protrusion tongue 16.64 10.86 7 39185 313 50565619
Rabbit syndrome 16.64 10.86 7 39185 313 50565619
Small intestine ulcer 16.29 10.86 7 39185 330 50565602
False positive investigation result 16.24 10.86 8 39184 517 50565415
Convulsive threshold lowered 16.13 10.86 7 39185 338 50565594
Product dose omission issue 16.06 10.86 215 38977 183623 50382309
Infusion site rash 15.99 10.86 11 39181 1331 50564601
Sinus bradycardia 15.93 10.86 33 39159 13150 50552782
Arthralgia 15.77 10.86 242 38950 438460 50127472
C-reactive protein increased 15.66 10.86 17 39175 66457 50499475
Skin burning sensation 15.37 10.86 28 39164 10157 50555775
Sleep disorder 15.31 10.86 86 39106 57197 50508735
Gingival pain 15.31 10.86 21 39171 5985 50559947
Coagulation factor V level increased 15.20 10.86 3 39189 6 50565926
Nightmare 14.67 10.86 36 39156 16050 50549882
Vascular stent thrombosis 14.64 10.86 9 39183 900 50565032
Depressed level of consciousness 14.56 10.86 79 39113 51874 50514058
Product confusion 14.34 10.86 3 39189 9 50565923
Band sensation 14.18 10.86 8 39184 682 50565250
Hypersensitivity 14.14 10.86 103 39089 215058 50350874
Multiple organ dysfunction syndrome 14.08 10.86 11 39181 50326 50515606
Underdose 14.06 10.86 41 39151 20237 50545695
Hepatic function abnormal 13.94 10.86 4 39188 32677 50533255
Lower respiratory tract infection 13.43 10.86 34 39158 95167 50470765
Lactose intolerance 13.39 10.86 13 39179 2557 50563375
Psychomotor hyperactivity 13.32 10.86 25 39167 9276 50556656
Tracheo-oesophageal fistula 13.22 10.86 7 39185 527 50565405
Impaired healing 13.21 10.86 21 39171 69765 50496167
Myocardial infarction 13.19 10.86 31 39161 88996 50476936
Infusion site warmth 13.09 10.86 10 39182 1424 50564508
Stupor 13.09 10.86 15 39177 3568 50562364
Therapeutic response unexpected 12.83 10.86 34 39158 15881 50550051
Metastases to lymph nodes 12.81 10.86 21 39171 7003 50558929
Basophil count increased 12.80 10.86 8 39184 824 50565108
Thyroid cyst 12.75 10.86 7 39185 566 50565366
Aplastic anaemia 12.68 10.86 22 39170 7681 50558251
Urine ketone body present 12.53 10.86 12 39180 2321 50563611
Tinnitus 12.51 10.86 49 39143 28083 50537849
Sinus disorder 12.49 10.86 37 39155 18421 50547511
Infusion site discomfort 12.40 10.86 8 39184 870 50565062
Activation syndrome 12.31 10.86 5 39187 204 50565728
Fall 12.31 10.86 343 38849 334589 50231343
Poisoning deliberate 12.25 10.86 22 39170 7890 50558042
Agitation 12.25 10.86 77 39115 53307 50512625
Product dose omission in error 12.24 10.86 12 39180 2388 50563544
Snoring 12.08 10.86 14 39178 3370 50562562
Confusional arousal 12.06 10.86 4 39188 91 50565841
Water intoxication 12.01 10.86 6 39186 400 50565532
Oral cavity fistula 12 10.86 7 39185 636 50565296
Pregnancy 11.93 10.86 4 39188 29573 50536359
Nasal congestion 11.89 10.86 74 39118 51046 50514886
Alcoholic pancreatitis 11.51 10.86 3 39189 28 50565904
Muscle spasms 11.44 10.86 148 39044 125405 50440527
Mental status changes 11.44 10.86 57 39135 36215 50529717
Pre-existing condition improved 11.33 10.86 20 39172 7077 50558855
Product administered to patient of inappropriate age 11.32 10.86 12 39180 2618 50563314
Meningitis aseptic 11.32 10.86 15 39177 4137 50561795
Diarrhoea 11.25 10.86 560 38632 587916 49978016
Sleep terror 11.24 10.86 7 39185 716 50565216
Paradoxical drug reaction 11.24 10.86 14 39178 3633 50562299
Status epilepticus 11.18 10.86 29 39163 13377 50552555
Infusion site swelling 11.17 10.86 20 39172 7156 50558776
Anticholinergic syndrome 11.12 10.86 10 39182 1785 50564147
Galactorrhoea 11.01 10.86 14 39178 3709 50562223
Infective pulmonary exacerbation of cystic fibrosis 11.00 10.86 21 39171 7888 50558044
Oculogyric crisis 10.93 10.86 9 39183 1428 50564504

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
Appendicolith 186.17 12.01 79 24220 3401 29546827
Intentional self-injury 136.03 12.01 99 24200 12362 29537866
Appendicitis 127.10 12.01 83 24216 8696 29541532
Stress 86.04 12.01 97 24202 21393 29528835
Victim of child abuse 83.70 12.01 30 24269 815 29549413
Cardiogenic shock 82.65 12.01 90 24209 19100 29531128
Hallucination 78.95 12.01 136 24163 44576 29505652
Abdominal distension 73.77 12.01 134 24165 45777 29504451
Congenital hiatus hernia 72.79 12.01 23 24276 419 29549809
Parasomnia 59.93 12.01 19 24280 350 29549878
Constipation 56.61 12.01 214 24085 113946 29436282
Agitation 54.27 12.01 126 24173 51178 29499050
Aggression 51.17 12.01 99 24200 35442 29514786
Intentional overdose 46.78 12.01 100 24199 38428 29511800
Respiratory depression 44.12 12.01 55 24244 13468 29536760
Epidural lipomatosis 40.89 12.01 17 24282 694 29549534
Insomnia 39.59 12.01 161 24138 88600 29461628
Choreoathetosis 38.05 12.01 18 24281 1002 29549226
Dystonia 37.30 12.01 43 24256 9706 29540522
Fall 37.23 12.01 261 24038 176917 29373311
Ascites 36.60 12.01 88 24211 36531 29513697
Product prescribing error 36.15 12.01 58 24241 17918 29532310
Somnolence 34.69 12.01 161 24138 93794 29456434
Abnormal sleep-related event 33.49 12.01 13 24286 443 29549785
Hyponatraemia 32.82 12.01 126 24173 67507 29482721
Product administered to patient of inappropriate age 31.03 12.01 22 24277 2633 29547595
Confusional state 30.82 12.01 195 24104 127682 29422546
Extrapyramidal disorder 30.55 12.01 41 24258 10790 29539438
Juvenile idiopathic arthritis 30.01 12.01 17 24282 1377 29548851
Electrocardiogram QT interval abnormal 29.64 12.01 8 24291 81 29550147
Multiple organ dysfunction syndrome 29.33 12.01 116 24183 63000 29487228
Drug dependence 28.44 12.01 57 24242 20924 29529304
Breath sounds abnormal 27.79 12.01 28 24271 5429 29544799
Suicidal behaviour 27.65 12.01 16 24283 1349 29548879
Ventricular fibrillation 26.41 12.01 47 24252 15786 29534442
Abnormal behaviour 25.76 12.01 58 24241 23069 29527159
Hospice care 23.98 12.01 25 24274 5043 29545185
Aplastic anaemia 23.63 12.01 30 24269 7480 29542748
Hallucinations, mixed 23.56 12.01 18 24281 2415 29547813
Dyskinesia 21.99 12.01 50 24249 20011 29530217
Interstitial lung disease 21.89 12.01 10 24289 57708 29492520
Bronchiectasis 21.82 12.01 27 24272 6558 29543670
Tardive dyskinesia 21.48 12.01 24 24275 5234 29544994
Salivary hypersecretion 20.83 12.01 28 24271 7381 29542847
Mixed dementia 20.71 12.01 8 24291 269 29549959
Bladder dilatation 20.49 12.01 13 24286 1295 29548933
Drooling 20.15 12.01 18 24281 3003 29547225
Hepatic function abnormal 19.92 12.01 4 24295 39255 29510973
Muscle rigidity 19.79 12.01 31 24268 9380 29540848
Suicidal ideation 19.63 12.01 68 24231 34648 29515580
Stoma site discharge 19.25 12.01 11 24288 906 29549322
Malignant melanoma in situ 19.03 12.01 12 24287 1182 29549046
Gallbladder enlargement 18.87 12.01 11 24288 940 29549288
Myocardial infarction 18.79 12.01 39 24260 110257 29439971
Psychomotor hyperactivity 18.60 12.01 28 24271 8185 29542043
Multiple drug therapy 18.53 12.01 8 24291 359 29549869
Device kink 18.53 12.01 8 24291 359 29549869
Vomiting 18.38 12.01 260 24039 212000 29338228
Pleurothotonus 17.98 12.01 11 24288 1027 29549201
Gastric hypomotility 17.75 12.01 5 24294 60 29550168
Mental status changes 17.70 12.01 66 24233 34861 29515367
Subacute cutaneous lupus erythematosus 17.22 12.01 10 24289 849 29549379
Anaemia 17.15 12.01 96 24203 200855 29349373
Acute kidney injury 17.01 12.01 138 24161 265129 29285099
Opisthotonus 16.90 12.01 8 24291 446 29549782
Poor quality sleep 16.87 12.01 25 24274 7208 29543020
Respiratory alkalosis 16.67 12.01 12 24287 1471 29548757
Renal impairment 16.32 12.01 26 24273 81307 29468921
Disease risk factor 16.24 12.01 3 24296 3 29550225
Hyperkalaemia 16.09 12.01 16 24283 61376 29488852
Seizure 16.02 12.01 131 24168 92992 29457236
Speech disorder 15.94 12.01 49 24250 23467 29526761
Off label use 15.78 12.01 340 23959 300460 29249768
Dementia 15.00 12.01 31 24268 11627 29538601
Arrhythmia supraventricular 14.95 12.01 10 24289 1089 29549139
Full blood count abnormal 14.91 12.01 36 24263 14977 29535251
Abscess intestinal 14.75 12.01 11 24288 1423 29548805
Embedded device 14.69 12.01 6 24293 234 29549994
Acute myocardial infarction 14.67 12.01 11 24288 48427 29501801
Hypersomnia 14.31 12.01 29 24270 10725 29539503
Parkinsonian rest tremor 14.23 12.01 5 24294 128 29550100
Viral diarrhoea 14.15 12.01 5 24294 130 29550098
Sepsis 14.07 12.01 179 24120 142503 29407725
Restlessness 13.96 12.01 45 24254 22100 29528128
Progesterone increased 13.93 12.01 3 24296 10 29550218
Product dose omission issue 13.68 12.01 130 24169 96253 29453975
Stoma site infection 13.61 12.01 8 24291 695 29549533
Glycogen storage disease type VIII 13.50 12.01 3 24296 12 29550216
Renal failure 13.47 12.01 51 24248 118548 29431680
Intentional product misuse 13.21 12.01 60 24239 34601 29515627
Crying 13.21 12.01 19 24280 5332 29544896
Acanthosis nigricans 13.20 12.01 5 24294 159 29550069
Camptocormia 13.12 12.01 5 24294 162 29550066
Tremor 12.94 12.01 104 24195 73434 29476794
Device issue 12.85 12.01 23 24276 7757 29542471
Delirium 12.71 12.01 65 24234 39332 29510896
Abdominal pain 12.58 12.01 168 24131 135189 29415039
Haematuria traumatic 12.52 12.01 5 24294 184 29550044
Nausea 12.40 12.01 318 23981 288937 29261291
Tic 12.37 12.01 11 24288 1824 29548404
Ear infection 12.18 12.01 23 24276 8077 29542151
Influenza B virus test positive 12.04 12.01 4 24295 86 29550142

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
Intentional self-injury 370.05 10.78 252 51890 28792 64417798
Intentional overdose 221.56 10.78 316 51826 89628 64356962
Appendicolith 187.58 10.78 79 52063 3390 64443200
Somnolence 165.89 10.78 448 51694 203197 64243393
Pneumonia aspiration 131.06 10.78 198 51944 59073 64387517
Gastrooesophageal reflux disease 125.38 10.78 234 51908 82909 64363681
Appendicitis 100.06 10.78 85 52057 13484 64433106
Hallucination 91.72 10.78 190 51952 72598 64373992
Coma 88.16 10.78 209 51933 87406 64359184
Victim of child abuse 83.27 10.78 30 52112 841 64445749
Congenital hiatus hernia 70.01 10.78 22 52120 400 64446190
Desmoplastic small round cell tumour 68.34 10.78 15 52127 57 64446533
Insomnia 61.42 10.78 319 51823 197517 64249073
Constipation 59.99 10.78 353 51789 228984 64217606
Synovitis 56.10 10.78 7 52135 99083 64347507
Cardiogenic shock 53.58 10.78 95 52047 32332 64414258
Contraindicated product administered 53.46 10.78 11 52131 107818 64338772
Agitation 53.33 10.78 175 51967 88192 64358398
Parasomnia 50.92 10.78 18 52124 477 64446113
Ascites 49.95 10.78 136 52006 61865 64384725
Aggression 48.35 10.78 112 52030 46120 64400470
Cestode infection 48.24 10.78 15 52127 263 64446327
Joint swelling 47.19 10.78 63 52079 215319 64231271
Treatment failure 46.66 10.78 18 52124 116798 64329792
Stress 43.11 10.78 127 52015 60407 64386183
Premenstrual syndrome 42.53 10.78 16 52126 508 64446082
Disturbance in attention 42.40 10.78 99 52043 40975 64405615
Abdominal distension 39.44 10.78 168 51974 95826 64350764
Pericarditis 39.09 10.78 3 52139 62513 64384077
Aplastic anaemia 38.86 10.78 52 52090 13868 64432722
Irritability 38.40 10.78 89 52053 36657 64409933
Seizure 38.01 10.78 248 51894 166644 64279946
Lip pruritus 37.93 10.78 16 52126 689 64445901
Hepatic function abnormal 37.76 10.78 4 52138 64309 64382281
Epidural lipomatosis 37.72 10.78 17 52125 860 64445730
Suicidal ideation 36.81 10.78 128 52014 66414 64380176
Maternal exposure during pregnancy 36.31 10.78 16 52126 95868 64350722
Drug dependence 36.26 10.78 82 52060 33230 64413360
Interstitial lung disease 35.93 10.78 17 52125 97715 64348875
Drug hypersensitivity 34.81 10.78 89 52053 237726 64208864
Dystonia 34.75 10.78 58 52084 18807 64427783
Lichen sclerosus 34.23 10.78 16 52126 881 64445709
Polymenorrhoea 34.01 10.78 16 52126 894 64445696
Exposure during pregnancy 32.66 10.78 11 52131 77664 64368926
Abnormal sleep-related event 32.58 10.78 15 52127 798 64445792
Abnormal behaviour 32.50 10.78 79 52063 33543 64413047
Fall 31.80 10.78 493 51649 416333 64030257
Rheumatoid arthritis 31.19 10.78 53 52089 164241 64282349
Magnesium deficiency 31.03 10.78 13 52129 550 64446040
Menstruation delayed 30.34 10.78 16 52126 1143 64445447
Onychoclasis 30.29 10.78 27 52115 4565 64442025
Drug intolerance 30.17 10.78 67 52075 187925 64258665
Choreoathetosis 29.67 10.78 17 52125 1430 64445160
Extrapyramidal disorder 29.40 10.78 55 52087 19497 64427093
Systemic lupus erythematosus 29.30 10.78 13 52129 77599 64368991
Tremor 28.86 10.78 212 51930 148018 64298572
Wound 28.58 10.78 13 52129 76464 64370126
Myocardial infarction 28.36 10.78 57 52085 165764 64280826
Product administered to patient of inappropriate age 28.28 10.78 26 52116 4575 64442015
Respiratory depression 28.12 10.78 60 52082 23383 64423207
Anxiety 27.84 10.78 268 51874 202381 64244209
Glossodynia 27.48 10.78 9 52133 64687 64381903
Suicidal behaviour 27.47 10.78 21 52121 2866 64443724
Mental status changes 27.44 10.78 110 52032 61052 64385538
Product prescribing error 27.04 10.78 76 52066 35193 64411397
Restless legs syndrome 26.81 10.78 49 52093 17067 64429523
Derailment 26.21 10.78 7 52135 69 64446521
Restlessness 26 10.78 81 52061 39704 64406886
Discomfort 25.51 10.78 17 52125 80861 64365729
Hypersomnia 25.44 10.78 52 52090 19665 64426925
Confusional state 24.74 10.78 321 51821 260823 64185767
Renal failure 24.32 10.78 71 52071 181617 64264973
Drug ineffective 23.96 10.78 508 51634 839739 63606851
Arthropathy 23.91 10.78 38 52104 120929 64325661
Product dose omission issue 23.59 10.78 251 51891 194496 64252094
Akathisia 23.39 10.78 37 52105 11473 64435117
Tachycardia 23.15 10.78 203 51939 149376 64297214
Oculogyric crisis 23.14 10.78 18 52124 2520 64444070
Fatigue 22.87 10.78 778 51364 747952 63698638
Cognitive disorder 22.30 10.78 96 52046 54991 64391599
Acute kidney injury 22.27 10.78 244 51898 448996 63997594
C-reactive protein increased 21.55 10.78 27 52115 94882 64351708
Infusion site scar 21.18 10.78 8 52134 257 64446333
Swelling 21.16 10.78 63 52079 160155 64286435
Renal impairment 20.94 10.78 49 52093 134968 64311622
Hospice care 20.55 10.78 28 52114 7597 64438993
Tic 20.53 10.78 17 52125 2602 64443988
Feeling abnormal 20.51 10.78 181 51961 133421 64313169
Mixed dementia 20.48 10.78 8 52134 282 64446308
Stoma site discharge 20.01 10.78 14 52128 1668 64444922
Helplessness 19.57 10.78 8 52134 318 64446272
Tumour marker abnormal 19.44 10.78 7 52135 196 64446394
Salivary hypersecretion 19.38 10.78 35 52107 12078 64434512
Vision blurred 19.21 10.78 132 52010 90184 64356406
Autism spectrum disorder 19.15 10.78 11 52131 930 64445660
Rabbit syndrome 19.06 10.78 8 52134 340 64446250
Body temperature fluctuation 19.04 10.78 18 52124 3280 64443310
On and off phenomenon 19.02 10.78 16 52126 2503 64444087
Full blood count abnormal 18.91 10.78 60 52082 29697 64416893
Bladder dilatation 18.78 10.78 14 52128 1840 64444750
Influenza B virus test positive 18.78 10.78 8 52134 353 64446237
Tri-iodothyronine free decreased 18.78 10.78 8 52134 353 64446237
Juvenile idiopathic arthritis 18.37 10.78 19 52123 3860 64442730
Hepatic failure 18.35 10.78 11 52131 55383 64391207
Arthralgia 18.20 10.78 250 51892 442010 64004580
Crying 18.14 10.78 46 52096 20044 64426546
Memory impairment 18.09 10.78 125 52017 85557 64361033
Metastases to peritoneum 17.94 10.78 18 52124 3529 64443061
Ventricular fibrillation 17.89 10.78 51 52091 23809 64422781
Behaviour disorder 17.87 10.78 20 52122 4442 64442148
Dysarthria 17.85 10.78 95 52047 59311 64387279
Delirium 17.72 10.78 106 52036 69088 64377502
Eye movement disorder 17.59 10.78 25 52117 7054 64439536
Gallbladder enlargement 17.58 10.78 12 52130 1374 64445216
Electrocardiogram PR prolongation 17.57 10.78 12 52130 1375 64445215
Psychomotor hyperactivity 17.34 10.78 37 52105 14414 64432176
Antipsychotic drug level increased 17.26 10.78 21 52121 5094 64441496
Electrocardiogram QT interval abnormal 17.03 10.78 7 52135 282 64446308
Psychotic disorder 16.98 10.78 64 52078 34514 64412076
Hyponatraemia 16.95 10.78 189 51953 148150 64298440
Intentional product misuse 16.79 10.78 108 52034 72187 64374403
Gingival pain 16.58 10.78 23 52119 6344 64440246
Drug reaction with eosinophilia and systemic symptoms 16.30 10.78 12 52130 54205 64392385
Dyskinesia 16.21 10.78 69 52073 39319 64407271
Skin burning sensation 16.20 10.78 30 52112 10553 64436037
Anaphylactic reaction 16.15 10.78 19 52123 68645 64377945
Alopecia 16.07 10.78 74 52068 165616 64280974
Nightmare 15.86 10.78 45 52097 20948 64425642
Acute respiratory failure 15.79 10.78 81 52061 49853 64396737
Underdose 15.43 10.78 51 52091 25778 64420812
Therapeutic response unexpected 15.43 10.78 39 52103 16962 64429628
Abnormal dreams 15.41 10.78 29 52113 10327 64436263
False positive investigation result 15.33 10.78 9 52133 792 64445798
Anaphylactic shock 15.22 10.78 3 52139 30325 64416265
Helicobacter infection 15.16 10.78 6 52136 38356 64408234
Angiokeratoma 15.16 10.78 6 52136 219 64446371
Adhesive tape use 15.07 10.78 3 52139 6 64446584
Disease risk factor 15.07 10.78 3 52139 6 64446584
Neuralgia 15.02 10.78 51 52091 26133 64420457
Protrusion tongue 14.90 10.78 7 52135 390 64446200
Gaze palsy 14.88 10.78 14 52128 2536 64444054
Staphylococcal scalded skin syndrome 14.85 10.78 7 52135 393 64446197
Therapeutic product effect decreased 14.77 10.78 46 52096 115305 64331285
Malignant melanoma in situ 14.66 10.78 12 52130 1808 64444782
Angioedema 14.66 10.78 17 52125 61804 64384786
Infusion site pruritus 14.62 10.78 14 52128 2592 64443998
International normalised ratio increased 14.59 10.78 26 52116 79141 64367449
Cytomegalovirus infection 14.41 10.78 6 52136 37193 64409397
Inflammation 14.39 10.78 19 52123 65281 64381309
Parasitic gastroenteritis 14.34 10.78 4 52138 47 64446543
Paradoxical drug reaction 14.31 10.78 21 52121 6099 64440491
Respiratory syncytial virus infection 14.27 10.78 23 52119 7245 64439345
Breath sounds abnormal 14.15 10.78 30 52112 11639 64434951
Opisthotonus 14.07 10.78 8 52134 663 64445927
Type 2 diabetes mellitus 13.98 10.78 5 52137 34015 64412575
Infusion related reaction 13.93 10.78 77 52065 164390 64282200
Mood altered 13.82 10.78 36 52106 15943 64430647
Hepatitis 13.81 10.78 10 52132 45572 64401018
Urine ketone body present 13.55 10.78 15 52127 3292 64443298
Drooling 13.53 10.78 19 52123 5300 64441290
Suicide attempt 13.49 10.78 101 52041 70906 64375684
Unresponsive to stimuli 13.42 10.78 78 52064 50315 64396275
Hallucination, visual 13.24 10.78 51 52091 27783 64418807
Cytokine release syndrome 13.23 10.78 42 52100 20787 64425803
Acanthosis nigricans 13.20 10.78 5 52137 162 64446428
Urine leukocyte esterase positive 13.19 10.78 15 52127 3388 64443202
Glycogen storage disease type VIII 13.17 10.78 3 52139 14 64446576
Infusion site discomfort 13.09 10.78 8 52134 758 64445832
Hypersensitivity 13.06 10.78 99 52043 196353 64250237
Product confusion 13.00 10.78 3 52139 15 64446575
Infusion site warmth 12.93 10.78 9 52133 1063 64445527
Anaemia 12.86 10.78 222 51920 378458 64068132
Toxic epidermal necrolysis 12.85 10.78 7 52135 37159 64409431
Benign prostatic hyperplasia 12.82 10.78 25 52117 9140 64437450
Infective pulmonary exacerbation of cystic fibrosis 12.79 10.78 29 52113 11767 64434823
Muscle rigidity 12.76 10.78 37 52105 17436 64429154
Infusion site rash 12.68 10.78 9 52133 1097 64445493
Haematuria traumatic 12.57 10.78 5 52137 185 64446405
Abdominal pain 12.55 10.78 336 51806 312039 64134551
Anticonvulsant drug level decreased 12.55 10.78 11 52131 1819 64444771
Sleep disorder 12.54 10.78 87 52055 59622 64386968
Snoring 12.32 10.78 17 52125 4665 64441925
Drug eruption 12.22 10.78 7 52135 36129 64410461
Hepatic enzyme increased 12.03 10.78 59 52083 129884 64316706
Abscess intestinal 11.98 10.78 12 52130 2348 64444242
Thyroid cyst 11.95 10.78 6 52136 387 64446203
Lower respiratory tract infection 11.92 10.78 38 52104 94576 64352014
Child abuse 11.86 10.78 5 52137 215 64446375
Stoma site infection 11.79 10.78 9 52133 1226 64445364
Epilepsy 11.75 10.78 56 52086 33475 64413115
Creatinine urine decreased 11.73 10.78 5 52137 221 64446369
Stupor 11.71 10.78 19 52123 6016 64440574
Therapeutic response decreased 11.69 10.78 15 52127 52173 64394417
Drug resistance 11.58 10.78 7 52135 35095 64411495
Dissociative disorder 11.56 10.78 6 52136 415 64446175
Slow speech 11.54 10.78 11 52131 2026 64444564
Nausea 11.49 10.78 759 51383 785041 63661549
Electrocardiogram QRS complex prolonged 11.48 10.78 24 52118 9220 64437370
Sepsis 11.42 10.78 255 51887 230086 64216504
Oral cavity fistula 11.40 10.78 7 52135 669 64445921
Basophil count increased 11.38 10.78 9 52133 1291 64445299
Small intestine ulcer 11.28 10.78 7 52135 681 64445909
Chronic sinusitis 11.13 10.78 19 52123 6273 64440317
Viral diarrhoea 11.08 10.78 5 52137 254 64446336
Poor quality sleep 10.95 10.78 37 52105 18914 64427676
Device leakage 10.90 10.78 22 52120 8244 64438346
Thrombocytopenia 10.88 10.78 122 52020 223679 64222911
Activation syndrome 10.86 10.78 5 52137 266 64446324
Parkinsonian rest tremor 10.84 10.78 5 52137 267 64446323
Camptocormia 10.81 10.78 6 52136 475 64446115

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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 (View source of the data)

DiseaseRelationSNOMED_IDDOID
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




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Mustelids Acceleration of the fur priming cycle Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
PrimeX Wildlife Laboratories Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Melatonin receptor type 1B GPCR AGONIST EC50 9.70 WOMBAT-PK IUPHAR
Melatonin receptor type 1A GPCR AGONIST EC50 9.40 WOMBAT-PK IUPHAR
Nuclear receptor ROR-alpha Nuclear hormone receptor EC50 9 WOMBAT-PK
Myeloperoxidase Enzyme IC50 5.52 CHEMBL
Histamine H3 receptor GPCR Ki 9.30 CHEMBL
Cytochrome P450 1B1 Enzyme Ki 4.85 CHEMBL
5-hydroxytryptamine receptor 2B GPCR ANTAGONIST Ki 5.20 IUPHAR
Ribosyldihydronicotinamide dehydrogenase [quinone] Enzyme Ki 7.56 CHEMBL
Melatonin receptor type 1B GPCR Ki 9.15 CHEMBL
Melatonin receptor GPCR Ki 9.75 CHEMBL
Melatonin receptor type 1C GPCR EC50 9.91 CHEMBL

External reference:

IDSource
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