melatonin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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) 1.16 mg/mL Bocci G, Oprea TI, Benet LZ
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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 1.118 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.562 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 60.674 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 3.396 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 72.820 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 85.110 % High 1
herg hERG pIC50 4.106 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.950 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 8.730 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 67.880 % High 1
kinase-safety-class ACVR2A,ACVR2B,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GRK3,GSK3B,ITK,JAK1,JAK2,KIT,MAP3K1,MAP3K21,MAP3K7,MAPK1,MAPK10,MAPK7,MAPK8,MAPK9,MAPKAPK2,MARK4,MET,MTOR,NTRK2,PAK4,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1 57
kinase-selectivity-class AXL,BRAF,MAP2K6 3
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.718 High 1
mh-clint Mouse hepatocyte intrinsic clearance 8.017 High 1
mppb Mouse plasma protein binding (% unbound) 71.570 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 3.105 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 74.870 % High 1
rh-clint Rat hepatocyte intrinsic clearance 5.768 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 96.210 % High 1
rppb Rat plasma protein binding (% unbound) 71.240 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 950.605 uM High 1

Approvals:

DateAgencyCompanyOrphan
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 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 736.38 9.74 374 62453 28960 90536660
Intentional overdose 580.16 9.74 497 62330 93337 90472283
Somnolence 303.29 9.74 530 62297 208554 90357066
Pneumonia aspiration 269.52 9.74 225 62602 40715 90524905
Coma 207.73 9.74 254 62573 72378 90493242
Pemphigus 206.84 9.74 4 62823 326860 90238760
Glossodynia 176.35 9.74 12 62815 321767 90243853
Synovitis 173.10 9.74 15 62812 329737 90235883
Hand deformity 168.61 9.74 9 62818 296353 90269267
Pericarditis 164.43 9.74 5 62822 270146 90295474
Contraindicated product administered 164.19 9.74 16 62811 320123 90245497
Systemic lupus erythematosus 153.37 9.74 32 62795 361864 90203756
Wound 134.25 9.74 24 62803 302956 90262664
Maternal exposure during pregnancy 133.10 9.74 42 62785 360021 90205599
Duodenal ulcer perforation 131.46 9.74 5 62822 221283 90344337
Arthropathy 127.96 9.74 47 62780 366195 90199425
Helicobacter infection 125.61 9.74 8 62819 226842 90338778
Folliculitis 120.09 9.74 5 62822 204348 90361272
Muscle injury 108.45 9.74 3 62824 176651 90388969
Joint swelling 102.32 9.74 119 62708 503181 90062439
Discomfort 101.35 9.74 32 62795 274303 90291317
Desmoplastic small round cell tumour 99.06 9.74 21 62806 79 90565541
Treatment failure 96.45 9.74 45 62782 303883 90261737
Gastrooesophageal reflux disease 93.01 9.74 290 62537 166047 90399573
Rheumatic fever 92.54 9.74 3 62824 153118 90412502
Swelling 90.75 9.74 94 62733 418964 90146656
Irritable bowel syndrome 84.48 9.74 20 62807 207428 90358192
Type 2 diabetes mellitus 80.04 9.74 21 62806 203223 90362397
Therapeutic product effect decreased 79.34 9.74 47 62780 277524 90288096
Hepatic enzyme increased 79.13 9.74 80 62747 360656 90204964
Infusion related reaction 78.94 9.74 104 62723 416676 90148944
Impaired healing 78.52 9.74 32 62795 234167 90331453
Clostridium test positive 78.21 9.74 48 62779 5353 90560267
Suicide attempt 78.20 9.74 166 62661 75233 90490387
Seizure 77.96 9.74 258 62569 152371 90413249
Feeling abnormal 76.94 9.74 273 62554 166962 90398658
Aplastic anaemia 75.26 9.74 67 62760 13202 90552418
Exposure during pregnancy 74.54 9.74 36 62791 238374 90327246
Suicidal ideation 73.61 9.74 160 62667 73695 90491925
Sleep disorder due to general medical condition, insomnia type 72.85 9.74 4 62823 128690 90436930
Liver injury 72.36 9.74 15 62812 170552 90395068
Psoriatic arthropathy 72.12 9.74 34 62793 228301 90337319
General physical health deterioration 72.07 9.74 84 62743 355031 90210589
C-reactive protein abnormal 72.02 9.74 4 62823 127425 90438195
Drug intolerance 71.91 9.74 125 62702 447466 90118154
Rheumatoid arthritis 68.12 9.74 91 62736 362523 90203097
Alopecia 64.48 9.74 156 62671 494915 90070705
Lower respiratory tract infection 62.86 9.74 49 62778 250610 90315010
Tremor 62.04 9.74 240 62587 152933 90412687
Disturbance in attention 61.22 9.74 114 62713 46995 90518625
Joint range of motion decreased 59.48 9.74 11 62816 135632 90429988
Injury 58.41 9.74 32 62795 197317 90368303
Abdominal discomfort 56.34 9.74 158 62669 477170 90088450
Hypercholesterolaemia 54.53 9.74 4 62823 100888 90464732
Pulmonary fibrosis 53.45 9.74 6 62821 107497 90458123
Constipation 53.40 9.74 355 62472 280040 90285580
Blister 53.14 9.74 59 62768 254939 90310681
Facet joint syndrome 52.90 9.74 4 62823 98385 90467235
Drug hypersensitivity 52.85 9.74 156 62671 463453 90102167
Choroidal effusion 52.53 9.74 20 62807 769 90564851
Mobility decreased 52.27 9.74 58 62769 250676 90314944
Infection 52.09 9.74 108 62719 361986 90203634
Insomnia 51.27 9.74 401 62426 333073 90232547
Cestode infection 48.71 9.74 15 62812 299 90565321
On and off phenomenon 48.45 9.74 27 62800 2516 90563104
Hypersensitivity 48.28 9.74 158 62669 454519 90111101
Wound infection 48.03 9.74 8 62819 106394 90459226
Electrocardiogram PR prolongation 47.16 9.74 19 62808 851 90564769
Lip dry 46.90 9.74 7 62820 100948 90464672
Fatigue 45.97 9.74 1084 61743 1152939 89412681
Product dose omission issue 45.51 9.74 352 62475 291335 90274285
Mental status changes 44.74 9.74 97 62730 44582 90521038
Fall 44.47 9.74 520 62307 481290 90084330
Restless legs syndrome 43.46 9.74 65 62762 22405 90543215
Inflammation 43.40 9.74 36 62791 178556 90387064
COVID-19 43.19 9.74 231 62596 168612 90397008
Agitation 43.17 9.74 123 62704 66975 90498645
Poisoning deliberate 42.86 9.74 55 62772 16431 90549189
Wheezing 42.43 9.74 62 62765 238018 90327602
Freezing phenomenon 42.25 9.74 22 62805 1790 90563830
Fibromyalgia 41.59 9.74 49 62778 206220 90359400
Tic 41.14 9.74 22 62805 1889 90563731
Irritability 41.07 9.74 82 62745 35580 90530040
Hallucination 40.59 9.74 119 62708 65840 90499780
Abnormal behaviour 40.30 9.74 63 62764 22565 90543055
Anxiety 38.86 9.74 356 62471 309416 90256204
Completed suicide 38.84 9.74 201 62626 144857 90420763
Gastrointestinal disorder 38.23 9.74 75 62752 256612 90309008
Premenstrual syndrome 38.16 9.74 16 62811 794 90564826
Stomatitis 37.77 9.74 84 62743 274614 90291006
Deep vein thrombosis postoperative 37.72 9.74 3 62824 70806 90494814
Tachycardia 37.17 9.74 211 62616 157462 90408158
Drug ineffective 36.84 9.74 708 62119 1383590 89182030
Bursitis 36.60 9.74 23 62804 131631 90433989
Peripheral venous disease 36.38 9.74 7 62820 83914 90481706
Vision blurred 35.40 9.74 161 62666 110132 90455488
Balance disorder 34.42 9.74 146 62681 96934 90468686
Metastases to peritoneum 34.09 9.74 26 62801 4129 90561491
Grip strength decreased 33.80 9.74 11 62816 92565 90473055
Illness 33.63 9.74 129 62698 81840 90483780
Dermatitis atopic 33.29 9.74 59 62768 23413 90542207
Magnesium deficiency 32.86 9.74 14 62813 723 90564897
Onychoclasis 31.72 9.74 32 62795 7367 90558253
C-reactive protein increased 31.57 9.74 48 62779 181341 90384279
Neuralgia 31.10 9.74 68 62759 31432 90534188
Osteoarthritis 31.07 9.74 55 62772 195675 90369945
Hypersomnia 30.38 9.74 54 62773 21477 90544143
Lip pruritus 30.25 9.74 16 62811 1344 90564276
Vascular stent thrombosis 30.25 9.74 15 62812 1101 90564519
Lichen sclerosus 30.22 9.74 16 62811 1347 90564273
Psychotic symptom 30.01 9.74 19 62808 2237 90563383
Red blood cell sedimentation rate increased 29.83 9.74 10 62817 82585 90483035
Polymenorrhoea 29.63 9.74 16 62811 1401 90564219
Urinary tract infection 29.56 9.74 333 62494 305299 90260321
Musculoskeletal pain 29.15 9.74 46 62781 171205 90394415
Epilepsy with myoclonic-atonic seizures 29.09 9.74 8 62819 105 90565515
Acute respiratory failure 28.90 9.74 80 62747 42838 90522782
Ill-defined disorder 28.42 9.74 53 62774 184838 90380782
Menstruation delayed 28.37 9.74 18 62809 2127 90563493
Derailment 28.05 9.74 7 62820 61 90565559
Angiokeratoma 27.56 9.74 8 62819 129 90565491
Choanal stenosis 27.44 9.74 6 62821 27 90565593
Abnormal dreams 26.85 9.74 36 62791 11221 90554399
Night sweats 26.58 9.74 30 62797 128736 90436884
Neutrophil count increased 26.55 9.74 48 62779 19342 90546278
Autoimmune disorder 26.50 9.74 10 62817 76734 90488886
Angle closure glaucoma 26.44 9.74 19 62808 2756 90562864
Bone erosion 26.25 9.74 3 62824 53018 90512602
Obesity 25.96 9.74 21 62806 105486 90460134
Akathisia 25.57 9.74 35 62792 11124 90554496
Snoring 25.40 9.74 24 62803 5102 90560518
Pregnancy 25.21 9.74 6 62821 62041 90503579
Body temperature fluctuation 25.00 9.74 17 62810 2258 90563362
Lethargy 24.78 9.74 98 62729 63041 90502579
Rhabdomyolysis 24.69 9.74 85 62742 51171 90514449
Diarrhoea 24.35 9.74 836 61991 938354 89627266
Peripheral swelling 24.31 9.74 177 62650 412929 90152691
Adjustment disorder with depressed mood 24.04 9.74 5 62822 56748 90508872
Arthralgia 23.84 9.74 388 62439 778134 89787486
Dyskinesia 23.52 9.74 67 62760 36467 90529153
Restlessness 23.48 9.74 66 62761 35654 90529966
Blood cholesterol increased 22.94 9.74 71 62756 207941 90357679
Sciatica 22.75 9.74 22 62805 101360 90464260
Myocarditis 22.61 9.74 37 62790 13769 90551851
False positive investigation result 22.51 9.74 11 62816 782 90564838
Depressed level of consciousness 22.43 9.74 105 62722 72679 90492941
Hepatic cirrhosis 22.25 9.74 8 62819 63245 90502375
Staphylococcal scalded skin syndrome 22.21 9.74 7 62820 151 90565469
Liver disorder 22.16 9.74 31 62796 121238 90444382
Myelosuppression 22.13 9.74 5 62822 53586 90512034
Musculoskeletal stiffness 22.13 9.74 118 62709 296414 90269206
Congenital hypoplasia of depressor angularis oris muscle 22.01 9.74 6 62821 76 90565544
Vasoplegia syndrome 21.76 9.74 17 62810 2797 90562823
Gait inability 21.61 9.74 43 62784 146413 90419207
Nail disorder 21.59 9.74 7 62820 59060 90506560
X-ray abnormal 21.44 9.74 3 62824 45421 90520199
Urticaria 21.41 9.74 128 62699 312606 90253014
Respiratory syncytial virus infection 21.25 9.74 31 62796 10449 90555171
Helplessness 21.23 9.74 8 62819 299 90565321
Nausea 21.20 9.74 956 61871 1109360 89456260
Confusional arousal 21.18 9.74 8 62819 301 90565319
Creatinine urine decreased 21.15 9.74 8 62819 302 90565318
Hallucination, visual 20.73 9.74 48 62779 23044 90542576
Basal ganglia infarction 20.59 9.74 9 62818 495 90565125
Nasal congestion 20.56 9.74 113 62714 83301 90482319
Psychomotor hyperactivity 20.53 9.74 34 62793 12779 90552841
Rabbit syndrome 20.43 9.74 8 62819 332 90565288
Ascites 20.29 9.74 76 62751 47664 90517956
Aggression 20.27 9.74 52 62775 26616 90539004
Sleep apnoea syndrome 20.22 9.74 58 62769 31689 90533931
Infusion site pain 19.93 9.74 43 62784 19695 90545925
Infusion site pruritus 19.88 9.74 24 62803 6741 90558879
Self-injurious ideation 19.83 9.74 17 62810 3186 90562434
Somnambulism 19.80 9.74 23 62804 6205 90559415
Death 19.63 9.74 434 62393 456117 90109503
Attention deficit hyperactivity disorder 19.61 9.74 19 62808 4165 90561455
Tumour marker abnormal 19.49 9.74 8 62819 376 90565244
Urine leukocyte esterase positive 19.47 9.74 17 62810 3265 90562355
Blood viscosity abnormal 19.31 9.74 7 62820 234 90565386
Water intoxication 19.22 9.74 9 62818 582 90565038
Impaired gastric emptying 19.21 9.74 33 62794 12776 90552844
Change in seizure presentation 19.20 9.74 9 62818 583 90565037
Anticonvulsant drug level decreased 19.15 9.74 12 62815 1388 90564232
Cognitive disorder 19.14 9.74 97 62730 69310 90496310
Tri-iodothyronine free decreased 19.12 9.74 8 62819 395 90565225
Product use issue 19.09 9.74 142 62685 329777 90235843
Prescribed overdose 18.81 9.74 24 62803 97601 90468019
Foot deformity 18.64 9.74 9 62818 59642 90505978
Immunodeficiency common variable 18.48 9.74 8 62819 430 90565190
Pre-existing condition improved 18.41 9.74 27 62800 9142 90556478
Medication error 18.27 9.74 19 62808 84633 90480987
Hospitalisation 17.99 9.74 151 62676 127949 90437671
Galactorrhoea 17.86 9.74 19 62808 4653 90560967
Defiant behaviour 17.78 9.74 4 62823 21 90565599
Product preparation issue 17.77 9.74 14 62813 2332 90563288
Hip arthroplasty 17.73 9.74 16 62811 76192 90489428
Poor quality sleep 17.60 9.74 47 62780 24646 90540974
Knee arthroplasty 17.58 9.74 19 62808 83163 90482457
Hepatitis 17.50 9.74 14 62813 70725 90494895
Lupus-like syndrome 17.49 9.74 6 62821 48840 90516780
Crying 17.46 9.74 48 62779 25597 90540023
Unresponsive to stimuli 17.31 9.74 62 62765 38059 90527561
Premature delivery 17.30 9.74 3 62824 38759 90526861
Nightmare 17.18 9.74 43 62784 21682 90543938
Hyperprolactinaemia 17.16 9.74 20 62807 5413 90560207
Infusion site rash 17.07 9.74 14 62813 2469 90563151
Tinnitus 16.99 9.74 67 62760 43035 90522585
Aorta hypoplasia 16.98 9.74 6 62821 186 90565434
Epistaxis 16.92 9.74 109 62718 85016 90480604
Mental disorder 16.81 9.74 55 62772 32263 90533357
Cerebral mass effect 16.79 9.74 10 62817 1056 90564564
Orgasmic sensation decreased 16.75 9.74 3 62824 3 90565617
Interstitial lung disease 16.66 9.74 17 62810 76388 90489232
Lung disorder 16.63 9.74 51 62776 149832 90415788
Depressed mood 16.62 9.74 74 62753 50148 90515472
Protrusion tongue 16.49 9.74 7 62820 358 90565262
Hypoxia 16.47 9.74 96 62731 72303 90493317
Headache 16.24 9.74 742 62085 862004 89703616
White blood cell count decreased 16.10 9.74 182 62645 166927 90398693
Metastases to lymph nodes 16.08 9.74 29 62798 11660 90553960
Hepatic function abnormal 16.03 9.74 6 62821 46282 90519338
Infusion site swelling 16.03 9.74 29 62798 11691 90553929
Infusion site scar 15.99 9.74 8 62819 598 90565022
Small intestine ulcer 15.98 9.74 7 62820 387 90565233
Band sensation 15.91 9.74 10 62817 1163 90564457
Lymphocyte count decreased 15.91 9.74 57 62770 34993 90530627
Anticholinergic syndrome 15.85 9.74 14 62813 2729 90562891
Skin burning sensation 15.70 9.74 39 62788 19572 90546048
Depression 15.64 9.74 294 62533 300307 90265313
Cyclothymic disorder 15.53 9.74 6 62821 240 90565380
Coagulation factor V level increased 15.53 9.74 3 62824 6 90565614
Influenza 15.43 9.74 156 62671 139108 90426512
Heart rate increased 15.28 9.74 132 62695 112770 90452850
Intentional product use issue 15.25 9.74 88 62739 216804 90348816
Hyporesponsive to stimuli 15.24 9.74 11 62816 1606 90564014
Breast cancer stage II 15.20 9.74 3 62824 35331 90530289
Therapeutic product effect incomplete 15.11 9.74 76 62751 193820 90371800
Encephalopathy 15.05 9.74 68 62759 46376 90519244
Oculogyric crisis 15.03 9.74 13 62814 2466 90563154
Sedation complication 14.96 9.74 35 62792 16909 90548711
Symptom recurrence 14.95 9.74 16 62811 3943 90561677
Convulsive threshold lowered 14.85 9.74 7 62820 459 90565161
Metapneumovirus infection 14.73 9.74 10 62817 1325 90564295
Hepatic cytolysis 14.65 9.74 51 62776 30865 90534755
Gingival pain 14.65 9.74 25 62802 9627 90555993
Febrile neutropenia 14.60 9.74 171 62656 158178 90407442
Hospice care 14.55 9.74 25 62802 9679 90555941
Upper airway obstruction 14.51 9.74 9 62818 1023 90564597
Product administered to patient of inappropriate age 14.48 9.74 17 62810 4636 90560984
Adverse event 14.47 9.74 38 62789 117380 90448240
Onychomadesis 14.28 9.74 7 62820 45991 90519629
Hot flush 14.26 9.74 80 62747 59408 90506212
Dysarthria 14.23 9.74 75 62752 54407 90511213
Feeding disorder 14.20 9.74 35 62792 17477 90548143
Chloasma 14.09 9.74 5 62822 157 90565463
Arthritis 13.96 9.74 64 62763 167251 90398369
Drug interaction 13.90 9.74 269 62558 276184 90289436
Sinus bradycardia 13.88 9.74 34 62793 16918 90548702
Parasitic gastroenteritis 13.87 9.74 4 62823 63 90565557
Hypotension 13.87 9.74 309 62518 325088 90240532
Nephritis allergic 13.83 9.74 6 62821 324 90565296
Stupor 13.80 9.74 18 62809 5464 90560156
Anal incontinence 13.76 9.74 33 62794 16197 90549423
Pyrexia 13.67 9.74 351 62476 660134 89905486
Extrapyramidal disorder 13.67 9.74 33 62794 16270 90549350
Parainfluenzae virus infection 13.65 9.74 13 62814 2790 90562830
Basophil count increased 13.61 9.74 9 62818 1142 90564478
Infective pulmonary exacerbation of cystic fibrosis 13.51 9.74 25 62802 10254 90555366
Therapy non-responder 13.46 9.74 49 62778 136655 90428965
Back pain 13.46 9.74 301 62526 316874 90248746
Lactose intolerance 13.41 9.74 14 62813 3355 90562265
Lower limb fracture 13.38 9.74 24 62803 84989 90480631
Starvation 13.38 9.74 7 62820 575 90565045
Skin laceration 13.26 9.74 44 62783 25991 90539629
Enuresis 13.25 9.74 14 62813 3400 90562220
Mental impairment 13.12 9.74 33 62794 16687 90548933
Neuropathy peripheral 13.11 9.74 149 62678 136821 90428799
Hypertension 13 9.74 231 62596 457301 90108319
Neutrophil hypersegmented morphology present 13.00 9.74 3 62824 18 90565602
Rash 12.99 9.74 437 62390 795663 89769957
Viral infection 12.94 9.74 60 62767 41354 90524266
Prescribed underdose 12.90 9.74 20 62807 74999 90490621
Behaviour disorder 12.90 9.74 16 62811 4619 90561001
Urine ketone body present 12.74 9.74 12 62815 2540 90563080
Oral cavity fistula 12.71 9.74 7 62820 637 90564983
Onychomycosis 12.69 9.74 5 62822 37371 90528249
Oedema 12.66 9.74 84 62743 200211 90365409
Dyspepsia 12.58 9.74 83 62744 198077 90367543
Thyroid cyst 12.49 9.74 7 62820 659 90564961
Clostridium difficile infection 12.45 9.74 54 62773 36191 90529429
Infusion site warmth 12.36 9.74 11 62816 2167 90563453
Thrombosis 12.30 9.74 90 62737 73161 90492459
Volvulus 12.25 9.74 11 62816 2192 90563428
Sleep-related eating disorder 12.23 9.74 8 62819 996 90564624
Muscle tightness 12.13 9.74 28 62799 13411 90552209
Coeliac disease 12.11 9.74 8 62819 44602 90521018
Polychromasia 12.06 9.74 5 62822 241 90565379
Activation syndrome 12.06 9.74 5 62822 241 90565379
Infusion site discomfort 11.98 9.74 10 62817 1806 90563814
Tracheo-oesophageal fistula 11.93 9.74 7 62820 719 90564901
Psychotic disorder 11.87 9.74 48 62779 31182 90534438
Small intestinal obstruction 11.83 9.74 37 62790 21197 90544423
Sinus tachycardia 11.79 9.74 45 62782 28468 90537152
Anger 11.75 9.74 28 62799 13692 90551928
Mitochondrial myopathy 11.72 9.74 5 62822 259 90565361
Road traffic accident 11.67 9.74 37 62790 107589 90458031
Mood altered 11.58 9.74 32 62795 17112 90548508
Dizziness 11.54 9.74 509 62318 588775 89976845
Diabetic neuropathy 11.48 9.74 15 62812 4559 90561061
Alcoholic pancreatitis 11.48 9.74 3 62824 32 90565588
Thyroid function test abnormal 11.47 9.74 14 62813 3975 90561645
Respiratory depression 11.46 9.74 30 62797 15545 90550075
Stress 11.46 9.74 96 62731 81299 90484321
Platelet transfusion 11.44 9.74 8 62819 1112 90564508
Xerosis 11.41 9.74 9 62818 1502 90564118
Cortisol increased 11.39 9.74 6 62821 500 90565120
Rhinorrhoea 11.30 9.74 102 62725 88214 90477406
Therapeutic response unexpected 11.17 9.74 37 62790 21843 90543777
Clinomania 11.16 9.74 3 62824 36 90565584
Anaphylactic shock 11.12 9.74 4 62823 31613 90534007
Decubitus ulcer 11.09 9.74 25 62802 11788 90553832
Hypercapnia 11.08 9.74 18 62809 6659 90558961
Complement factor C4 decreased 11.06 9.74 5 62822 298 90565322
Feeling drunk 11.02 9.74 15 62812 4743 90560877
Hallucination, auditory 10.97 9.74 30 62797 15945 90549675
Oropharyngeal pain 10.89 9.74 125 62702 115062 90450558
Meningitis aseptic 10.89 9.74 18 62809 6755 90558865
Complement factor C3 decreased 10.86 9.74 5 62822 311 90565309
Gaze palsy 10.75 9.74 9 62818 1632 90563988
Osmophobia 10.68 9.74 4 62823 147 90565473
Eye contusion 10.64 9.74 11 62816 2605 90563015
Antiacetylcholine receptor antibody positive 10.63 9.74 4 62823 149 90565471
Sleep paralysis 10.56 9.74 7 62820 891 90564729
Red cell distribution width increased 10.55 9.74 25 62802 12182 90553438
Delusion 10.53 9.74 27 62800 13813 90551807
Screaming 10.53 9.74 13 62814 3737 90561883
Blood bicarbonate increased 10.47 9.74 7 62820 904 90564716
Antipsychotic drug level increased 10.45 9.74 13 62814 3766 90561854
Myocardial infarction 10.42 9.74 38 62789 105934 90459686
Tachyphylaxis 10.33 9.74 5 62822 348 90565272
Conduction disorder 10.32 9.74 9 62818 1726 90563894
Blepharospasm 10.30 9.74 14 62813 55431 90510189
Exostosis 10.30 9.74 13 62814 53121 90512499
Lack of infusion site rotation 10.29 9.74 4 62823 163 90565457
Laryngitis 10.28 9.74 12 62815 50741 90514879
Drug screen false positive 10.25 9.74 7 62820 936 90564684
Weight decreased 10.25 9.74 340 62487 379570 90186050
Amyloid related imaging abnormality-oedema/effusion 10.24 9.74 7 62820 937 90564683
Initial insomnia 10.23 9.74 21 62806 9289 90556331
Peroneal nerve palsy 10.23 9.74 16 62811 5732 90559888
Finger deformity 10.22 9.74 5 62822 32892 90532728
Paradoxical drug reaction 10.19 9.74 16 62811 5750 90559870
Product administration interrupted 10.17 9.74 25 62802 12467 90553153
Mydriasis 10.12 9.74 28 62799 14984 90550636
Postoperative ileus 10.11 9.74 6 62821 629 90564991
Infusion site irritation 10.09 9.74 8 62819 1345 90564275
Anomaly of external ear congenital 10.08 9.74 4 62823 172 90565448
Increased appetite 10.06 9.74 24 62803 11741 90553879
Adverse reaction 10.04 9.74 4 62823 29708 90535912
Biliary obstruction 10.00 9.74 12 62815 3350 90562270
Hypervolaemia 9.90 9.74 47 62780 32710 90532910
Suicidal behaviour 9.88 9.74 11 62816 2833 90562787
Cytokine release syndrome 9.85 9.74 42 62785 27931 90537689
Plasma cell myeloma 9.85 9.74 55 62772 40773 90524847
Ulcer haemorrhage 9.83 9.74 3 62824 26318 90539302
Haemorrhagic disorder 9.80 9.74 7 62820 1005 90564615
Analgesic therapy 9.80 9.74 6 62821 666 90564954
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits 9.79 9.74 6 62821 667 90564953
Asthma 9.78 9.74 114 62713 242046 90323574

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 326.03 11.41 199 48565 13257 42559314
Appendicitis 273.12 11.41 210 48554 20403 42552168
Congenital hiatus hernia 250.04 11.41 128 48636 6046 42566525
Cardiogenic shock 180.21 11.41 213 48551 35427 42537144
Stress 176.88 11.41 235 48529 43977 42528594
Blood phosphorus increased 166.74 11.41 128 48636 12397 42560174
Breath sounds abnormal 166.30 11.41 126 48638 11967 42560604
Ventricular fibrillation 157.22 11.41 183 48581 29940 42542631
Intentional self-injury 153.06 11.41 132 48632 15070 42557501
Malignant melanoma in situ 153.04 11.41 71 48693 2696 42569875
Abdominal distension 137.56 11.41 273 48491 71462 42501109
Myasthenia gravis 126.94 11.41 122 48642 16015 42556556
Constipation 117.39 11.41 430 48334 161861 42410710
Hyponatraemia 111.96 11.41 311 48453 101151 42471420
Benign prostatic hyperplasia 111.68 11.41 129 48635 20923 42551648
Micturition urgency 111.12 11.41 99 48665 11799 42560772
Hyperphosphataemia 109.31 11.41 102 48662 12902 42559669
Ascites 108.98 11.41 216 48548 56462 42516109
Somnolence 108.95 11.41 382 48382 140723 42431848
Joint injury 108.04 11.41 107 48657 14569 42558002
Chronic obstructive pulmonary disease 106.61 11.41 228 48536 62886 42509685
Hypercholesterolaemia 98.91 11.41 96 48668 12753 42559818
Victim of child abuse 93.25 11.41 39 48725 1150 42571421
Epidural lipomatosis 92.80 11.41 44 48720 1756 42570815
Analgesic therapy 91.96 11.41 69 48695 6455 42566116
Bronchiectasis 91.55 11.41 108 48656 17911 42554660
Multiple organ dysfunction syndrome 90.34 11.41 280 48484 96755 42475816
Blood uric acid increased 83.69 11.41 96 48668 15451 42557120
Full blood count abnormal 81.98 11.41 133 48631 29743 42542828
Blood cholesterol increased 81.62 11.41 125 48639 26616 42545955
Drug therapy 80.12 11.41 63 48701 6317 42566254
Incorrect route of product administration 77.57 11.41 116 48648 24189 42548382
Juvenile idiopathic arthritis 76.92 11.41 44 48720 2595 42569976
Hypophosphataemia 74.16 11.41 105 48659 20840 42551731
Agitation 73.73 11.41 200 48564 64114 42508457
Respiratory depression 71.91 11.41 98 48666 18770 42553801
Neuralgia 71.49 11.41 115 48649 25532 42547039
Transient ischaemic attack 71.46 11.41 134 48630 33605 42538966
Dry mouth 68.38 11.41 145 48619 39734 42532837
Aplastic anaemia 65.87 11.41 76 48688 12308 42560263
Bacterial infection 63.17 11.41 114 48650 27765 42544806
Iron deficiency 59.03 11.41 68 48696 10993 42561578
Intentional overdose 58.95 11.41 160 48604 51296 42521275
General physical health deterioration 58.29 11.41 333 48431 150913 42421658
Product prescribing error 58.17 11.41 106 48658 26006 42546565
Drug dependence 53.64 11.41 109 48655 28985 42543586
Interstitial lung disease 51.71 11.41 13 48751 78449 42494122
Aggression 50.26 11.41 137 48627 44026 42528545
Hallucination 49.86 11.41 162 48602 57345 42515226
Antacid therapy 49.59 11.41 42 48722 4675 42567896
Parasomnia 49.31 11.41 19 48745 450 42572121
Anticoagulant therapy 46.90 11.41 40 48724 4495 42568076
Activated partial thromboplastin time prolonged 46.65 11.41 73 48691 15830 42556741
Myocardial infarction 45.30 11.41 45 48719 123964 42448607
Sleep disorder 42.15 11.41 136 48628 47959 42524612
Child abuse 40.53 11.41 20 48744 872 42571699
Product administered to patient of inappropriate age 39.34 11.41 37 48727 4724 42567847
Extrapyramidal disorder 38.31 11.41 68 48696 16344 42556227
Swelling 37.55 11.41 143 48621 54742 42517829
Renal impairment 36.92 11.41 43 48721 110185 42462386
Suicidal ideation 36.75 11.41 130 48634 48031 42524540
Salivary hypersecretion 36.01 11.41 53 48711 10890 42561681
Sepsis 35.86 11.41 367 48397 198967 42373604
Fall 35.41 11.41 417 48347 234103 42338468
Acute kidney injury 35.20 11.41 261 48503 367076 42205495
Hepatic function abnormal 35.04 11.41 8 48756 51559 42521012
Growth hormone-producing pituitary tumour 35.01 11.41 11 48753 138 42572433
Oculogyric crisis 34.98 11.41 23 48741 1742 42570829
Intentional product misuse 34.98 11.41 152 48612 61748 42510823
Gastric hypomotility 34.84 11.41 12 48752 204 42572367
Sleep disorder therapy 34.48 11.41 41 48723 6853 42565718
End stage renal disease 34.10 11.41 65 48699 16493 42556078
Toxicity to various agents 33.24 11.41 142 48622 228994 42343577
Abdominal pain 32.98 11.41 348 48416 190123 42382448
Seizure 32.65 11.41 243 48521 120318 42452253
Obstructive airways disorder 32.46 11.41 81 48683 24678 42547893
Shunt malfunction 31.76 11.41 12 48752 269 42572302
Abnormal sleep-related event 31.61 11.41 14 48750 476 42572095
Disease progression 31.39 11.41 74 48690 143582 42428989
Choreoathetosis 31.01 11.41 18 48746 1091 42571480
Acute myocardial infarction 30.75 11.41 14 48750 58151 42514420
Insomnia 30.70 11.41 236 48528 118017 42454554
Gastrooesophageal reflux disease 30.54 11.41 117 48647 44906 42527665
Dissociative disorder 30.34 11.41 15 48749 657 42571914
Viral diarrhoea 30.03 11.41 12 48752 314 42572257
Clostridium test positive 29.63 11.41 34 48730 5471 42567100
Asthma 29.29 11.41 145 48619 62169 42510402
Bacteroides infection 29.19 11.41 24 48740 2563 42570008
Paradoxical drug reaction 28.48 11.41 31 48733 4707 42567864
Ulcer 28.42 11.41 60 48704 16381 42556190
Vomiting 28.30 11.41 477 48287 289246 42283325
Myelosuppression 28.05 11.41 6 48758 40455 42532116
Blood calcium increased 27.90 11.41 41 48723 8413 42564158
Suicidal behaviour 27.88 11.41 19 48745 1527 42571044
Obesity 27.23 11.41 59 48705 16400 42556171
Dyskinesia 27.13 11.41 77 48687 25313 42547258
Aortic stenosis 26.84 11.41 41 48723 8704 42563867
Dopamine dysregulation syndrome 26.49 11.41 13 48751 560 42572011
Dystonia 26.08 11.41 50 48714 12740 42559831
Drooling 25.62 11.41 28 48736 4271 42568300
Troponin increased 24.60 11.41 62 48702 19000 42553571
Diabetes mellitus 24.22 11.41 134 48630 59953 42512618
Cytomegalovirus infection 24.08 11.41 4 48760 32302 42540269
Irregular sleep phase 23.85 11.41 8 48756 125 42572446
Psychomotor hyperactivity 23.79 11.41 44 48720 10914 42561657
Gout 23.38 11.41 78 48686 27977 42544594
Rash 23.17 11.41 204 48560 276750 42295821
Rheumatoid arthritis 22.77 11.41 10 48754 42430 42530141
Renal failure 22.76 11.41 86 48678 143640 42428931
Delirium 22.44 11.41 119 48645 52400 42520171
Bronchopulmonary aspergillosis allergic 22.43 11.41 27 48737 4571 42568000
Blood growth hormone increased 22.22 11.41 12 48752 632 42571939
Electrocardiogram QT interval abnormal 21.91 11.41 7 48757 93 42572478
Cyanosis 21.65 11.41 51 48713 14980 42557591
Hallucinations, mixed 21.57 11.41 23 48741 3412 42569159
Coronary artery disease 21.12 11.41 119 48645 53601 42518970
Scaphocephaly 21.09 11.41 6 48758 52 42572519
Aspiration 20.85 11.41 56 48708 17830 42554741
Total lung capacity decreased 20.84 11.41 23 48741 3547 42569024
Neutropenia 20.36 11.41 139 48625 199292 42373279
Mental impairment 20.20 11.41 44 48720 12273 42560298
Tremor 20.12 11.41 184 48580 96745 42475826
Enterococcus test positive 19.79 11.41 16 48748 1669 42570902
Rhabdomyolysis 19.71 11.41 37 48727 77982 42494589
Breath odour 19.70 11.41 13 48751 990 42571581
Intentional dose omission 19.40 11.41 36 48728 8950 42563621
Poor quality sleep 19.37 11.41 37 48727 9403 42563168
Eye movement disorder 19.31 11.41 26 48738 4919 42567652
Diarrhoea 19.25 11.41 392 48372 460457 42112114
Thrombocytopenia 19.24 11.41 133 48631 190146 42382425
Product administration interrupted 19.23 11.41 26 48738 4940 42567631
Bone marrow failure 19.06 11.41 7 48757 33086 42539485
Device kink 19.00 11.41 10 48754 500 42572071
Slow speech 18.94 11.41 16 48748 1774 42570797
Thrombosis 18.48 11.41 138 48626 68373 42504198
Leukopenia 18.40 11.41 36 48728 74710 42497861
Mixed dementia 18.23 11.41 8 48756 266 42572305
Cardiac failure 18.20 11.41 62 48702 106794 42465777
Productive cough 18.18 11.41 111 48653 51456 42521115
Hyperlipidaemia 18.08 11.41 60 48704 21456 42551115
Tardive dyskinesia 17.87 11.41 30 48734 6894 42565677
Screaming 17.78 11.41 16 48748 1931 42570640
Blood test abnormal 17.74 11.41 43 48721 12863 42559708
Rapid eye movement sleep behaviour disorder 17.16 11.41 8 48756 307 42572264
Hallucination, visual 17.12 11.41 58 48706 20962 42551609
No adverse event 17.07 11.41 89 48675 38932 42533639
Hospice care 17.02 11.41 33 48731 8480 42564091
Reduced facial expression 16.84 11.41 14 48750 1519 42571052
Arthralgia 16.78 11.41 152 48612 205086 42367485
Malaise 16.54 11.41 159 48605 211997 42360574
Product dose omission issue 16.46 11.41 258 48506 154107 42418464
Cardio-respiratory arrest 16.46 11.41 26 48738 58610 42513961
Respiratory arrest 16.39 11.41 6 48758 28418 42544153
Muscle rigidity 16.38 11.41 40 48724 12019 42560552
Foetal exposure during pregnancy 16.33 11.41 18 48746 47293 42525278
Chest discomfort 16.21 11.41 30 48734 63586 42508985
Confusional state 15.98 11.41 275 48489 167322 42405249
Blood lactate dehydrogenase increased 15.91 11.41 5 48759 26076 42546495
Tri-iodothyronine decreased 15.90 11.41 6 48758 134 42572437
Restlessness 15.89 11.41 71 48693 29178 42543393
Ear infection 15.85 11.41 41 48723 12763 42559808
Blood bilirubin increased 15.80 11.41 15 48749 42237 42530334
Morvan syndrome 15.79 11.41 4 48760 21 42572550
Mental status changes 15.71 11.41 92 48672 42023 42530548
Self-destructive behaviour 15.64 11.41 8 48756 377 42572194
Off label use 15.58 11.41 885 47879 637450 41935121
Product use issue 15.57 11.41 145 48619 76606 42495965
Drug ineffective 15.44 11.41 578 48186 629619 41942952
Inflammation 15.20 11.41 10 48754 33837 42538734
Malignant neoplasm progression 15.19 11.41 68 48696 108332 42464239
Traumatic haemothorax 15.09 11.41 8 48756 406 42572165
Abnormal behaviour 14.97 11.41 65 48699 26386 42546185
Tenderness 14.87 11.41 32 48732 8851 42563720
Shunt occlusion 14.78 11.41 11 48753 1016 42571555
Hypogonadism 14.76 11.41 16 48748 2418 42570153
On and off phenomenon 14.73 11.41 19 48745 3448 42569123
Painful ejaculation 14.47 11.41 6 48758 173 42572398
Loss of personal independence in daily activities 14.38 11.41 102 48662 49714 42522857
Haemorrhage 14.19 11.41 30 48734 60533 42512038
Camptocormia 14.19 11.41 6 48758 182 42572389
Insulin-like growth factor increased 14.10 11.41 13 48751 1618 42570953
Acute myeloid leukaemia 14.06 11.41 4 48760 22252 42550319
International normalised ratio increased 13.86 11.41 21 48743 48147 42524424
Anxiety 13.73 11.41 201 48563 118359 42454212
Bladder dilatation 13.71 11.41 13 48751 1677 42570894
Non-high-density lipoprotein cholesterol increased 13.66 11.41 6 48758 200 42572371
Dermatitis atopic 13.63 11.41 38 48726 12366 42560205
Infrequent bowel movements 13.58 11.41 11 48753 1151 42571420
Anaphylactic shock 13.50 11.41 5 48759 23512 42549059
Influenza B virus test positive 13.49 11.41 5 48759 106 42572465
Serotonin syndrome 13.48 11.41 62 48702 25783 42546788
Hyperkalaemia 13.48 11.41 47 48717 80411 42492160
Drug intolerance 13.45 11.41 146 48618 80278 42492293
Platelet count decreased 13.44 11.41 98 48666 138483 42434088
Cerebral haemorrhage 13.25 11.41 15 48749 38951 42533620
Stoma site discharge 13.22 11.41 12 48752 1464 42571107
Pleurothotonus 13.18 11.41 11 48753 1200 42571371
Thyroxine decreased 13.18 11.41 6 48758 218 42572353
Premature baby 13.16 11.41 5 48759 23148 42549423
Cogwheel rigidity 13.01 11.41 13 48751 1788 42570783
Progesterone increased 12.94 11.41 3 48761 10 42572561
Anaphylactic reaction 12.92 11.41 18 48746 42725 42529846
Hepatic failure 12.60 11.41 15 48749 38085 42534486
Glycogen storage disease type VIII 12.51 11.41 3 48761 12 42572559
Behaviour disorder 12.49 11.41 26 48738 7028 42565543
Arthritis 12.43 11.41 18 48746 42047 42530524
Illness 12.42 11.41 59 48705 24871 42547700
Blood glucose increased 12.38 11.41 43 48721 73656 42498915
Parkinsonism 12.12 11.41 33 48731 10590 42561981
Generalised tonic-clonic seizure 12.11 11.41 61 48703 26318 42546253
Melaena 12.03 11.41 16 48748 38730 42533841
Erythema 12.02 11.41 74 48690 108719 42463852
Circulatory collapse 12.01 11.41 6 48758 23630 42548941
Opisthotonus 11.93 11.41 8 48756 626 42571945
Angina pectoris 11.93 11.41 12 48752 32884 42539687
Embedded device 11.90 11.41 7 48757 435 42572136
Joint swelling 11.90 11.41 39 48725 67983 42504588
Toxic epidermal necrolysis 11.88 11.41 8 48756 26742 42545829
Dyspnoea exertional 11.86 11.41 98 48666 50050 42522521
Multiple drug therapy 11.76 11.41 10 48754 1119 42571452
Device dislocation 11.75 11.41 27 48737 7804 42564767
Hypersomnia 11.61 11.41 40 48724 14578 42557993
Dementia with Lewy bodies 11.60 11.41 9 48755 884 42571687
Acanthosis nigricans 11.43 11.41 5 48759 165 42572406
Prostate cancer 11.42 11.41 21 48743 44622 42527949

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 622.87 10.07 393 94810 37036 110457060
Intentional overdose 438.21 10.07 555 94648 131946 110362150
Appendicolith 381.87 10.07 204 94999 14051 110480045
Somnolence 356.45 10.07 789 94414 296660 110197436
Congenital hiatus hernia 286.12 10.07 129 95074 6130 110487966
Appendicitis 283.18 10.07 218 94985 28246 110465850
Synovitis 182.67 10.07 14 95189 274078 110220018
Blood phosphorus increased 179.93 10.07 133 95070 16207 110477889
Ventricular fibrillation 167.43 10.07 192 95011 41121 110452975
Cardiogenic shock 165.84 10.07 225 94978 57113 110436983
Pemphigus 165.56 10.07 4 95199 214566 110279530
Malignant melanoma in situ 158.72 10.07 72 95131 3470 110490626
Benign prostatic hyperplasia 156.38 10.07 128 95075 18106 110475990
Ascites 156.30 10.07 284 94919 92524 110401572
Stress 153.43 10.07 303 94900 105045 110389051
Pericarditis 152.42 10.07 9 95194 219105 110274991
Aplastic anaemia 150.91 10.07 142 95061 24166 110469930
Hand deformity 148.93 10.07 10 95193 218496 110275600
Myasthenia gravis 145.84 10.07 132 95071 21379 110472717
Constipation 145.58 10.07 652 94551 357134 110136962
Systemic lupus erythematosus 142.09 10.07 24 95179 254314 110239782
Pneumonia aspiration 137.32 10.07 249 94954 80984 110413112
Glossodynia 135.59 10.07 16 95187 221988 110272108
Duodenal ulcer perforation 130.99 10.07 5 95198 177695 110316401
Hyperphosphataemia 130.11 10.07 110 95093 16271 110477825
Breath sounds abnormal 129.03 10.07 133 95070 25271 110468825
Wound 126.88 10.07 24 95179 234413 110259683
Joint swelling 124.04 10.07 119 95084 442726 110051370
Maternal exposure during pregnancy 122.20 10.07 34 95169 254849 110239247
Micturition urgency 120.20 10.07 113 95090 19207 110474889
Folliculitis 119.35 10.07 6 95197 167647 110326449
Analgesic therapy 117.42 10.07 75 95128 7209 110486887
Chronic obstructive pulmonary disease 115.51 10.07 276 94927 108882 110385214
Neuralgia 114.83 10.07 173 95030 48305 110445791
Agitation 113.39 10.07 280 94923 112771 110381325
Arthropathy 113.04 10.07 53 95150 287469 110206627
Contraindicated product administered 110.26 10.07 38 95165 248229 110245867
Clostridium test positive 105.22 10.07 82 95121 10811 110483285
Blood uric acid increased 104.48 10.07 110 95093 21419 110472677
Victim of child abuse 103.31 10.07 39 95164 1172 110492924
Drug therapy 102.71 10.07 69 95134 7222 110486874
Seizure 102.15 10.07 419 94784 220766 110273330
Hyponatraemia 101.06 10.07 413 94790 217240 110276856
Helicobacter infection 99.74 10.07 18 95185 181859 110312237
Epidural lipomatosis 98.94 10.07 44 95159 2023 110492073
C-reactive protein abnormal 94.40 10.07 4 95199 129691 110364405
Suicidal ideation 93.50 10.07 232 94971 93705 110400391
Coma 92.93 10.07 267 94936 117602 110376494
Type 2 diabetes mellitus 92.03 10.07 20 95183 177212 110316884
Gastrooesophageal reflux disease 92.00 10.07 352 94851 179624 110314472
Treatment failure 91.91 10.07 63 95140 277171 110216925
Rheumatic fever 91.90 10.07 3 95200 122576 110371520
Psoriatic arthropathy 91.09 10.07 28 95175 196733 110297363
Desmoplastic small round cell tumour 91.06 10.07 21 95182 97 110493999
Abdominal distension 90.77 10.07 344 94859 174759 110319337
Respiratory depression 87.14 10.07 122 95081 31879 110462217
Infusion related reaction 85.65 10.07 122 95081 381040 110113056
Full blood count abnormal 84.96 10.07 164 95039 55888 110438208
Exposure during pregnancy 84.71 10.07 20 95183 167404 110326692
Impaired healing 82.48 10.07 33 95170 196684 110297412
Hallucination 82.13 10.07 232 94971 101200 110392896
Hypersensitivity 78.81 10.07 142 95061 403856 110090240
Rheumatoid arthritis 78.73 10.07 85 95118 299528 110194568
Irritable bowel syndrome 78.52 10.07 22 95181 164193 110329903
Joint injury 77.20 10.07 130 95073 39864 110454232
Multiple organ dysfunction syndrome 76.93 10.07 296 94907 151414 110342682
Therapeutic product effect decreased 76.45 10.07 59 95144 244257 110249839
Discomfort 76.36 10.07 45 95158 214662 110279434
Tremor 75.09 10.07 359 94844 201873 110292223
Alopecia 74.98 10.07 124 95079 364629 110129467
Suicide attempt 74.63 10.07 227 94976 103167 110390929
Sleep disorder due to general medical condition, insomnia type 74.49 10.07 4 95199 105639 110388457
Hypophosphataemia 72.38 10.07 114 95089 33068 110461028
Inflammation 72.33 10.07 38 95165 193200 110300896
Aggression 71.78 10.07 158 95045 59052 110435044
Bronchiectasis 69.61 10.07 118 95085 36375 110457721
Drug dependence 68.17 10.07 140 95063 49880 110444216
Antacid therapy 68.05 10.07 48 95155 5436 110488660
Bacterial infection 65.30 10.07 131 95072 45905 110448191
Iron deficiency 65.16 10.07 80 95123 18396 110475700
Transient ischaemic attack 64.70 10.07 159 95044 63823 110430273
Anticoagulant therapy 64.39 10.07 46 95157 5315 110488781
Facet joint syndrome 64.32 10.07 5 95198 96823 110397273
Fibromyalgia 63.39 10.07 34 95169 170875 110323221
Hepatic enzyme increased 63.28 10.07 112 95091 320780 110173316
Joint range of motion decreased 62.73 10.07 14 95189 121818 110372278
On and off phenomenon 62.64 10.07 42 95161 4382 110489714
Injury 61.84 10.07 38 95165 177227 110316869
Mental status changes 60.53 10.07 173 95030 75949 110418147
Juvenile idiopathic arthritis 59.71 10.07 46 95157 5961 110488135
Incorrect route of product administration 59.35 10.07 154 95049 63907 110430189
Fall 59.34 10.07 786 94417 602696 109891400
Sepsis 56.58 10.07 478 94725 326868 110167228
Disturbance in attention 56.37 10.07 148 95055 61847 110432249
Activated partial thromboplastin time prolonged 56.09 10.07 82 95121 22286 110471810
Interstitial lung disease 55.79 10.07 25 95178 139309 110354787
Extrapyramidal disorder 54.61 10.07 93 95110 28774 110465322
Product prescribing error 54.51 10.07 130 95073 51201 110442895
Liver injury 54.22 10.07 31 95172 150382 110343714
Arthralgia 53.68 10.07 422 94781 779210 109714886
Myelosuppression 52.44 10.07 9 95194 94331 110399765
Salivary hypersecretion 51.32 10.07 69 95134 17352 110476744
Sleep disorder therapy 50.94 10.07 46 95157 7425 110486671
Blister 50.82 10.07 73 95130 227303 110266793
Hepatic function abnormal 50.80 10.07 8 95195 89287 110404809
Lip dry 50.53 10.07 12 95191 100071 110394025
Osteoarthritis 50.00 10.07 50 95153 182573 110311523
Bursitis 49.43 10.07 25 95178 129893 110364203
Peripheral venous disease 49.08 10.07 7 95196 84110 110409986
Irritability 48.53 10.07 119 95084 47690 110446406
Product administered to patient of inappropriate age 48.07 10.07 46 95157 7990 110486106
Mobility decreased 46.67 10.07 83 95120 237339 110256757
Child abuse 46.03 10.07 20 95183 869 110493227
Cestode infection 45.80 10.07 15 95188 293 110493803
Musculoskeletal pain 45.79 10.07 54 95149 182969 110311127
Parasomnia 45.40 10.07 19 95184 752 110493344
Thrombosis 44.82 10.07 199 95004 108463 110385633
Abdominal discomfort 44.58 10.07 181 95022 393677 110100419
Wound infection 44.15 10.07 14 95189 96451 110397645
Product dose omission issue 42.62 10.07 444 94759 321338 110172758
Dyskinesia 41.95 10.07 118 95085 51328 110442768
End stage renal disease 41.71 10.07 70 95133 21403 110472693
Intentional product misuse 41.64 10.07 225 94978 132679 110361417
Drug ineffective 41.62 10.07 995 94208 1519545 108974551
Stomatitis 41.08 10.07 109 95094 270133 110223963
Urticaria 41.01 10.07 139 95064 318718 110175378
Hypersomnia 39.97 10.07 80 95123 27981 110466115
Deep vein thrombosis postoperative 39.55 10.07 3 95200 59288 110434808
Premenstrual syndrome 39.30 10.07 16 95187 590 110493506
Aortic stenosis 38.89 10.07 52 95151 13007 110481089
Dystonia 38.48 10.07 75 95128 25730 110468366
Pulmonary fibrosis 38.27 10.07 20 95183 102022 110392074
Troponin increased 37.86 10.07 81 95122 29685 110464411
Growth hormone-producing pituitary tumour 37.67 10.07 11 95192 144 110493952
Paradoxical drug reaction 37.05 10.07 44 95159 9773 110484323
Infection 37.00 10.07 173 95030 362027 110132069
Hallucination, visual 36.46 10.07 95 95108 39510 110454586
Rash 36.43 10.07 493 94710 820471 109673625
Abnormal behaviour 36.31 10.07 94 95109 38945 110455151
Lower respiratory tract infection 36.24 10.07 99 95104 243007 110251089
Akathisia 36.23 10.07 58 95145 17055 110477041
Anxiety 36.18 10.07 455 94748 344623 110149473
C-reactive protein increased 36.16 10.07 84 95119 217835 110276261
Grip strength decreased 36.04 10.07 12 95191 80162 110413934
Death 35.49 10.07 819 94384 698050 109796046
Tic 35.27 10.07 27 95176 3466 110490630
Mental impairment 35.24 10.07 67 95136 22572 110471524
Myocardial infarction 35.23 10.07 70 95133 192013 110302083
Night sweats 35.18 10.07 38 95165 133945 110360151
Poisoning deliberate 35.06 10.07 73 95130 26258 110467838
Gout 35.00 10.07 89 95114 36477 110457619
Red blood cell sedimentation rate increased 34.71 10.07 12 95191 78290 110415806
Restlessness 34.65 10.07 117 95086 56142 110437954
Ill-defined disorder 34.41 10.07 51 95152 156802 110337294
Dermatitis atopic 34.23 10.07 71 95132 25470 110468626
Feeling abnormal 33.95 10.07 269 94934 180442 110313654
Dissociative disorder 33.77 10.07 18 95185 1233 110492863
Abnormal sleep-related event 33.12 10.07 16 95187 890 110493206
Insomnia 33.05 10.07 464 94739 360126 110133970
Freezing phenomenon 32.75 10.07 23 95180 2586 110491510
Bacteroides infection 32.67 10.07 24 95179 2895 110491201
Peripheral swelling 32.47 10.07 209 94994 403825 110090271
Abdominal pain 32.14 10.07 620 94583 512369 109981727
Drooling 32.04 10.07 35 95168 7104 110486992
Shunt malfunction 31.87 10.07 12 95191 358 110493738
Psychomotor hyperactivity 31.55 10.07 60 95143 20217 110473879
Restless legs syndrome 31.31 10.07 67 95136 24559 110469537
Intentional product use issue 31.24 10.07 109 95094 247797 110246299
Myocarditis 30.71 10.07 75 95128 29980 110464116
Sciatica 30.59 10.07 21 95182 92378 110401718
Hepatitis 30.45 10.07 20 95183 90034 110404062
Gastric hypomotility 30.35 10.07 11 95192 294 110493802
Hyperlipidaemia 29.99 10.07 83 95120 35765 110458331
Electrocardiogram PR prolongation 29.76 10.07 19 95184 1824 110492272
Polymenorrhoea 29.59 10.07 16 95187 1128 110492968
Lichen sclerosus 29.28 10.07 16 95187 1152 110492944
Bone erosion 29.16 10.07 3 95200 46368 110447728
Nail disorder 29.14 10.07 7 95196 57928 110436168
False positive investigation result 29.04 10.07 17 95186 1397 110492699
Cytomegalovirus infection 28.54 10.07 6 95197 54438 110439658
Acute respiratory failure 28.19 10.07 134 95069 75126 110418970
Pregnancy 28.10 10.07 5 95198 51062 110443034
Liver disorder 27.70 10.07 50 95153 142193 110351903
Lip pruritus 27.43 10.07 16 95187 1306 110492790
Autoimmune disorder 27.41 10.07 11 95192 65472 110428624
Epilepsy with myoclonic-atonic seizures 27.17 10.07 8 95195 108 110493988
Tachycardia 26.88 10.07 306 94897 226339 110267757
Dysarthria 26.74 10.07 143 95060 83978 110410118
Viral diarrhoea 26.38 10.07 12 95191 582 110493514
Eye movement disorder 26.35 10.07 37 95166 9691 110484405
Choreoathetosis 26.17 10.07 17 95186 1681 110492415
Magnesium deficiency 26.12 10.07 13 95190 772 110493324
Arthritis 25.91 10.07 67 95136 167519 110326577
Gastrointestinal disorder 25.63 10.07 114 95089 241838 110252258
Body temperature fluctuation 25.27 10.07 23 95180 3750 110490346
Infusion site pain 25.22 10.07 50 95153 17369 110476727
Blood calcium increased 25.18 10.07 51 95152 17989 110476107
Derailment 25.08 10.07 7 95196 77 110494019
Adjustment disorder with depressed mood 24.80 10.07 4 95199 43879 110450217
Suicidal behaviour 24.77 10.07 22 95181 3475 110490621
Poor quality sleep 24.48 10.07 66 95137 28011 110466085
Irregular sleep phase 24.34 10.07 8 95195 158 110493938
Coronary artery disease 24.26 10.07 124 95079 71566 110422530
Drug hypersensitivity 24.16 10.07 262 94941 453828 110040268
Crying 24.13 10.07 62 95141 25566 110468530
Dyspepsia 24.03 10.07 84 95119 190881 110303215
Diabetes mellitus 23.90 10.07 157 95046 99224 110394872
Confusional arousal 23.28 10.07 8 95195 182 110493914
Cyanosis 23.07 10.07 67 95136 29674 110464422
Slow speech 23.06 10.07 21 95182 3427 110490669
Illness 23.01 10.07 135 95068 82036 110412060
Menstruation delayed 22.95 10.07 16 95187 1778 110492318
Aspiration 22.93 10.07 68 95135 30465 110463631
Psychotic symptom 22.88 10.07 22 95181 3845 110490251
Drug intolerance 22.66 10.07 232 94971 406280 110087816
Metastases to peritoneum 22.60 10.07 26 95177 5584 110488512
Psychotic disorder 22.31 10.07 95 95108 50842 110443254
Angiokeratoma 22.24 10.07 8 95195 209 110493887
Behaviour disorder 22.23 10.07 34 95169 9613 110484483
Lung disorder 22.12 10.07 80 95123 179967 110314129
Onychomadesis 22.04 10.07 6 95197 45657 110448439
Enterococcus test positive 22.04 10.07 19 95184 2885 110491211
Obstructive airways disorder 21.73 10.07 88 95115 46061 110448035
Infusion site swelling 21.63 10.07 34 95169 9843 110484253
Hypogonadism 21.43 10.07 16 95187 1978 110492118
Abnormal dreams 21.36 10.07 39 95164 12741 110481355
Therapy non-responder 21.30 10.07 67 95136 157240 110336856
Balance disorder 21.06 10.07 172 95031 116388 110377708
Rabbit syndrome 20.96 10.07 9 95194 380 110493716
Hospice care 20.77 10.07 38 95165 12435 110481661
Total lung capacity decreased 20.69 10.07 28 95175 7086 110487010
Anaphylactic reaction 20.66 10.07 42 95161 114258 110379838
Hyperkinesia 20.53 10.07 19 95184 3165 110490931
Mood altered 20.43 10.07 52 95151 21323 110472773
Lupus-like syndrome 20.38 10.07 5 95198 40787 110453309
Screaming 20.30 10.07 23 95180 4858 110489238
Coeliac disease 20.24 10.07 6 95197 43181 110450915
Influenza B virus test positive 20.21 10.07 9 95194 415 110493681
Blepharospasm 20.20 10.07 11 95192 54840 110439256
Lower limb fracture 20.19 10.07 21 95182 75327 110418769
Gait inability 19.97 10.07 56 95147 136320 110357776
Mixed dementia 19.91 10.07 8 95195 285 110493811
Blood growth hormone increased 19.75 10.07 12 95191 1056 110493040
Change in seizure presentation 19.74 10.07 11 95192 823 110493273
Tumour marker abnormal 19.70 10.07 8 95195 293 110493803
Medication error 19.66 10.07 38 95165 105328 110388768
Anaphylactic shock 19.48 10.07 10 95193 51536 110442560
Antipsychotic drug level increased 19.48 10.07 27 95176 6988 110487108
Muscle rigidity 19.47 10.07 55 95148 23976 110470120
Oculogyric crisis 19.34 10.07 20 95183 3812 110490284
Hypoxia 19.20 10.07 183 95020 129332 110364764
Serotonin syndrome 19.10 10.07 101 95102 59052 110435044
Painful ejaculation 19.04 10.07 6 95197 103 110493993
Fatigue 18.96 10.07 1251 93952 1214707 109279389
Nausea 18.86 10.07 1269 93934 1234421 109259675
Onychoclasis 18.83 10.07 27 95176 7210 110486886
Stoma site discharge 18.65 10.07 17 95186 2778 110491318
Unresponsive to stimuli 18.64 10.07 106 95097 63684 110430412
Bronchopulmonary aspergillosis allergic 18.44 10.07 29 95174 8397 110485699
Attention deficit hyperactivity disorder 18.41 10.07 21 95182 4470 110489626
Mental disorder 18.28 10.07 74 95129 38717 110455379
Infrequent bowel movements 18.09 10.07 15 95188 2160 110491936
Swelling 18.09 10.07 204 94999 350837 110143259
Urinary tract infection 17.97 10.07 387 94816 325895 110168201
Product confusion 17.87 10.07 7 95196 233 110493863
Helplessness 17.86 10.07 8 95195 374 110493722
Renal impairment 17.51 10.07 93 95110 188352 110305744
Hepatic failure 17.49 10.07 20 95183 68719 110425377
Generalised tonic-clonic seizure 17.41 10.07 93 95110 54587 110439509
Blood viscosity abnormal 17.35 10.07 7 95196 252 110493844
COVID-19 17.35 10.07 302 94901 244758 110249338
Breath odour 17.11 10.07 14 95189 1978 110492118
Dyspnoea exertional 16.92 10.07 150 95053 103910 110390186
Morvan syndrome 16.92 10.07 4 95199 21 110494075
Premature delivery 16.85 10.07 3 95200 30629 110463467
Infusion site scar 16.85 10.07 8 95195 428 110493668
Hip arthroplasty 16.79 10.07 14 95189 55799 110438297
Vision blurred 16.57 10.07 177 95026 128845 110365251
Sinus tachycardia 16.50 10.07 79 95124 44414 110449682
Tri-iodothyronine free decreased 16.46 10.07 8 95195 451 110493645
Electrocardiogram QRS complex prolonged 16.06 10.07 35 95168 12986 110481110
Camptocormia 15.99 10.07 8 95195 480 110493616
Protrusion tongue 15.99 10.07 8 95195 480 110493616
Viral infection 15.99 10.07 89 95114 53050 110441046
Respiratory syncytial virus infection 15.72 10.07 37 95166 14447 110479649
Anal incontinence 15.63 10.07 48 95155 21916 110472180
Insulin-like growth factor increased 15.39 10.07 14 95189 2282 110491814
Autism spectrum disorder 15.30 10.07 13 95190 1935 110492161
Onychomycosis 15.28 10.07 7 95196 38524 110455572
Electrocardiogram QT interval abnormal 15.21 10.07 7 95196 349 110493747
Traumatic haemothorax 15.12 10.07 9 95194 763 110493333
Infusion site pruritus 15.00 10.07 20 95183 4988 110489108
Toxic epidermal necrolysis 14.99 10.07 16 95187 56711 110437385
Drug-induced liver injury 14.97 10.07 53 95150 120014 110374082
Creatinine urine decreased 14.95 10.07 7 95196 363 110493733
Product preparation issue 14.93 10.07 15 95188 2764 110491332
Dementia with Lewy bodies 14.80 10.07 10 95193 1056 110493040
Finger deformity 14.79 10.07 5 95198 33087 110461009
Pyrexia 14.71 10.07 628 94575 897637 109596459
Cognitive disorder 14.67 10.07 127 95076 87384 110406712
Galactorrhoea 14.66 10.07 18 95185 4137 110489959
Bladder dilatation 14.66 10.07 14 95189 2425 110491671
Catatonia 14.66 10.07 31 95172 11269 110482827
Impaired gastric emptying 14.50 10.07 34 95169 13241 110480855
Hypertonia 14.49 10.07 26 95177 8380 110485716
Snoring 14.37 10.07 23 95180 6761 110487335
Urinary incontinence 14.37 10.07 81 95122 48506 110445590
Road traffic accident 14.36 10.07 46 95157 107352 110386744
Anticonvulsant drug level decreased 14.27 10.07 13 95190 2123 110491973
Oedema 14.23 10.07 114 95089 209862 110284234
Muscle tightness 14.20 10.07 36 95167 14726 110479370
Infective pulmonary exacerbation of cystic fibrosis 14.18 10.07 36 95167 14735 110479361
Back injury 14.12 10.07 12 95191 47387 110446709
Gaze palsy 14.08 10.07 16 95187 3391 110490705
Muscle twitching 14.02 10.07 57 95146 29878 110464218
Renal failure 14.02 10.07 126 95077 226448 110267648
Tardive dyskinesia 13.99 10.07 34 95169 13545 110480551
Pain 13.94 10.07 676 94527 954279 109539817
Infusion site irritation 13.92 10.07 10 95193 1165 110492931
Infusion site discomfort 13.90 10.07 12 95191 1825 110492271
Hepatic cirrhosis 13.86 10.07 23 95180 67603 110426493
Distractibility 13.84 10.07 9 95194 892 110493204
Encephalopathy 13.78 10.07 118 95085 80937 110413159
Hypervolaemia 13.68 10.07 81 95122 49379 110444717
Thinking abnormal 13.61 10.07 36 95167 15104 110478992
Mydriasis 13.57 10.07 46 95157 22111 110471985
Melaena 13.53 10.07 24 95179 68733 110425363
Acute myeloid leukaemia 13.52 10.07 8 95195 38102 110455994
Bone marrow failure 13.49 10.07 18 95185 57830 110436266
Intentional dose omission 13.48 10.07 43 95160 20037 110474059
Knee arthroplasty 13.40 10.07 22 95181 64926 110429170
Water intoxication 13.33 10.07 9 95194 950 110493146
Infusion site rash 13.24 10.07 13 95190 2330 110491766
Neutrophil count increased 13.20 10.07 62 95141 34590 110459506
Hydrocele 13.15 10.07 10 95193 1271 110492825
Glycogen storage disease type VIII 12.98 10.07 3 95200 14 110494082
Lung opacity 12.90 10.07 30 95173 11622 110482474
Swollen tongue 12.87 10.07 20 95183 60342 110433754
Sedation complication 12.86 10.07 42 95161 19813 110474283
Ulcer 12.83 10.07 72 95131 43044 110451052
Depressed mood 12.80 10.07 93 95110 60716 110433380
Lethargy 12.78 10.07 130 95073 93446 110400650
Taste disorder 12.71 10.07 23 95180 65364 110428732
Needle issue 12.71 10.07 39 95164 17801 110476295
Anticholinergic syndrome 12.68 10.07 17 95186 4263 110489833
Hallucinations, mixed 12.64 10.07 25 95178 8668 110485428
Dysphagia 12.61 10.07 194 95009 153406 110340690
Osteoporosis 12.60 10.07 36 95167 87116 110406980
Somnambulism 12.60 10.07 21 95182 6384 110487712
Pleurothotonus 12.54 10.07 13 95190 2485 110491611
Shunt occlusion 12.45 10.07 11 95192 1726 110492370
Opisthotonus 12.44 10.07 8 95195 778 110493318
Staphylococcal scalded skin syndrome 12.39 10.07 7 95196 538 110493558
Rectal haemorrhage 12.36 10.07 57 95146 119776 110374320
Hordeolum 12.33 10.07 18 95185 4883 110489213
Speech disorder 12.30 10.07 93 95110 61476 110432620
No adverse event 12.30 10.07 107 95096 73732 110420364
Frequent bowel movements 12.26 10.07 27 95176 71363 110422733
Infusion site warmth 12.25 10.07 11 95192 1762 110492334
Stoma site infection 12.14 10.07 11 95192 1784 110492312
Productive cough 12.08 10.07 151 95052 114154 110379942
Off label use 11.98 10.07 1470 93733 1498715 108995381
Panic attack 11.93 10.07 53 95150 28887 110465209
Colitis ulcerative 11.90 10.07 31 95172 77332 110416764
Acanthosis nigricans 11.76 10.07 5 95198 206 110493890
Haematoma muscle 11.74 10.07 16 95187 4074 110490022
International normalised ratio increased 11.71 10.07 37 95166 86735 110407361
Blood prolactin increased 11.61 10.07 17 95186 4625 110489471
Drug clearance 11.60 10.07 4 95199 92 110494004
Facial spasm 11.60 10.07 8 95195 874 110493222
Reduced facial expression 11.59 10.07 15 95188 3636 110490460
Tubulointerstitial nephritis 11.56 10.07 18 95185 54266 110439830
Faciobrachial dystonic seizure 11.56 10.07 4 95199 93 110494003
Malaise 11.55 10.07 467 94736 671352 109822744
Daydreaming 11.50 10.07 9 95194 1193 110492903
Parkinsonian rest tremor 11.49 10.07 6 95197 394 110493702
Hepatic cytolysis 11.48 10.07 84 95119 54969 110439127
Psychiatric decompensation 11.47 10.07 19 95184 5746 110488350
Skin burning sensation 11.39 10.07 43 95160 21782 110472314
Non-high-density lipoprotein cholesterol increased 11.38 10.07 6 95197 402 110493694
Product administration interrupted 11.35 10.07 28 95175 11264 110482832
Amyloid related imaging abnormality-oedema/effusion 11.34 10.07 10 95193 1565 110492531
Sleep paralysis 11.31 10.07 8 95195 910 110493186
Angioedema 11.29 10.07 45 95158 98455 110395641
Cytokine release syndrome 11.25 10.07 101 95102 70205 110423891
Immunodeficiency common variable 11.21 10.07 7 95196 647 110493449
Immune effector cell-associated neurotoxicity syndrome 11.17 10.07 33 95170 14749 110479347
Device issue 11.17 10.07 59 95144 34476 110459620
Urine leukocyte esterase positive 11.16 10.07 15 95188 3771 110490325
Skin laceration 11.15 10.07 58 95145 33695 110460401
Clostridium difficile infection 11.13 10.07 80 95123 52049 110442047
Impulsive behaviour 11.12 10.07 14 95189 3301 110490795
Sleep apnoea syndrome 11.03 10.07 66 95137 40381 110453715
Exostosis 11.02 10.07 14 95189 45942 110448154
Urine ketone body present 10.97 10.07 15 95188 3831 110490265
Leukopenia 10.92 10.07 79 95124 148712 110345384
Neutrophil hypersegmented morphology present 10.92 10.07 3 95200 31 110494065
Toxic skin eruption 10.91 10.07 5 95198 27510 110466586
Hyperprolactinaemia 10.91 10.07 20 95183 6555 110487541
Hypernatraemia 10.90 10.07 37 95166 17796 110476300
Oral cavity fistula 10.89 10.07 7 95196 680 110493416
Delirium 10.88 10.07 170 95033 134855 110359241
Gallbladder enlargement 10.84 10.07 11 95192 2051 110492045
Tenderness 10.72 10.07 52 95151 29385 110464711
Prescribed overdose 10.69 10.07 39 95164 87542 110406554
Wheezing 10.66 10.07 155 95048 255075 110239021
Musculoskeletal stiffness 10.64 10.07 173 95030 279649 110214447
Hypokinesia 10.58 10.07 42 95161 21784 110472312
Strabismus 10.52 10.07 14 95189 3485 110490611
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits 10.49 10.07 9 95194 1357 110492739
Drug screen false positive 10.48 10.07 9 95194 1360 110492736
Cardiac failure 10.47 10.07 107 95096 187519 110306577
Thyroid cyst 10.44 10.07 6 95197 476 110493620
Acute myocardial infarction 10.43 10.07 37 95166 83740 110410356
Stoma site odour 10.42 10.07 4 95199 126 110493970
Basal ganglia infarction 10.42 10.07 7 95196 733 110493363
Electrocardiogram change 10.35 10.07 9 95194 1382 110492714
Vomiting 10.32 10.07 914 94289 909761 109584335
Drug eruption 10.32 10.07 19 95184 53640 110440456
Infusion site erythema 10.31 10.07 28 95175 11931 110482165
Feeding disorder 10.27 10.07 41 95162 21321 110472775
Completed suicide 10.16 10.07 277 94926 242104 110251992
Band sensation 10.16 10.07 8 95195 1070 110493026
Intentional medical device removal by patient 10.15 10.07 6 95197 502 110493594
Basophil count increased 10.15 10.07 10 95193 1800 110492296
Device placement issue 10.12 10.07 10 95193 1807 110492289
Prescribed underdose 10.11 10.07 26 95177 65148 110428948
Inappropriate schedule of product administration 10.09 10.07 238 94965 203399 110290697
Dihydrotestosterone increased 10.09 10.07 3 95200 42 110494054
Blood test abnormal 10.09 10.07 50 95153 28504 110465592

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 D002492 Central Nervous System Depressants
MeSH PA D020011 Protective Agents
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:24621 hormone
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35488 central nervous system depressant
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35623 anticonvulsant
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:38070 anti-arrhythmia drug
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:48578 radical scavenger
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:50847 immunological adjuvant
CHEBI has role CHEBI:53784 antispasmodic drug
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:73336 vulnerary
CHEBI has role CHEBI:75771 mouse metabolite
CHEBI has role CHEBI:77746 human metabolite
CHEBI has role CHEBI:176497 geroprotector
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

N05CH Melatonin receptor agonists 2 drugs
ramelteontasimelteon

Drug Use | Suggest Off label Use Form| |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




🐶 Veterinary Drug Use

SpeciesUseRelation
Mustelids Acceleration of the fur priming cycle Indication

🐶 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 1A GPCR AGONIST EC50 9.40 WOMBAT-PK IUPHAR
Melatonin receptor type 1B GPCR AGONIST EC50 9.70 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
Palmitoleoyl-protein carboxylesterase NOTUM Enzyme IC50 4.12 CHEMBL
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
400000 MMSL
5037 MMSL
5609 MMSL
d04058 MMSL
005039 NDDF
116523008 SNOMEDCT_US
41199001 SNOMEDCT_US
JL5DK93RCL INXIGHT DRUGS

Pharmaceutical products:

None