promethazine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
2286 60-87-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • promethazine
  • diphergan
  • proazamine
  • prometazin
  • protazine
  • promethazine hydrochloride
  • promethazine HCl
A phenothiazine derivative with histamine H1-blocking, antimuscarinic, and sedative properties. It is used as an antiallergic, in pruritus, for motion sickness and sedation, and also in animals.
  • Molecular weight: 284.42
  • Formula: C17H20N2S
  • CLOGP: 4.60
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 0
  • TPSA: 6.48
  • ALOGS: -4.07
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
25 mg O
25 mg P
25 mg R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 5.03 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 25 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 14 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 14 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.09 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 14 hours Lombardo F, Berellini G, Obach RS
S (Water solubility) 100 mg/mL Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 2.998 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.303 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 38.994 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 69.663 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 7.680 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 16.960 % High 1
herg hERG pIC50 5.576 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 8.395 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 33.266 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 7.960 % High 1
kinase-safety-class ACVR2B,AKT2,AKT3,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,JAK3,MAP3K7,MAPK10,MAPK12,MAPK7,MET,NTRK2,PDK2,PDK4,PDPK1,PIM2,PRKDC,SIK2,STK33,TEK,TTK 34
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.344 High 1
mh-clint Mouse hepatocyte intrinsic clearance 181.970 High 1
mppb Mouse plasma protein binding (% unbound) 9.860 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.774 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
pppb Pig plasma protein binding (% unbound) 22.950 % High 1
rh-clint Rat hepatocyte intrinsic clearance 338.844 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 46.670 % High 1
rppb Rat plasma protein binding (% unbound) 9.050 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 803.526 uM High 1

Approvals:

DateAgencyCompanyOrphan
March 29, 1951 FDA DELCOR ASSET CORP

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 7398.76 10.68 2034 60413 27300 90538700
Intentional overdose 5807.76 10.68 2241 60206 91593 90474407
Akathisia 580.18 10.68 236 62211 10923 90555077
Tachycardia 468.61 10.68 560 61887 157113 90408887
Depressed level of consciousness 442.60 10.68 381 62066 72403 90493597
Mydriasis 280.53 10.68 157 62290 14855 90551145
Synovitis 192.83 10.68 8 62439 329744 90236256
Glossodynia 187.51 10.68 8 62439 321771 90244229
Contraindicated product administered 186.42 10.68 8 62439 320131 90245869
Hand deformity 184.80 10.68 4 62443 296358 90269642
Hallucination 180.60 10.68 225 62222 65734 90500266
Somnolence 177.30 10.68 423 62024 208661 90357339
Pericarditis 156.44 10.68 7 62440 270144 90295856
Agitation 145.25 10.68 204 62243 66894 90499106
Anxiety 144.89 10.68 506 61941 309266 90256734
Human rhinovirus test positive 144.02 10.68 44 62403 859 90565141
Systemic lupus erythematosus 142.13 10.68 37 62410 361859 90204141
Respiratory syncytial virus test positive 141.27 10.68 45 62402 1013 90564987
Arthropathy 140.90 10.68 39 62408 366203 90199797
Helicobacter infection 137.83 10.68 4 62443 226846 90339154
Drug ineffective 132.57 10.68 500 61947 1383798 89182202
Joint swelling 131.91 10.68 93 62354 503207 90062793
Hepatic enzyme increased 123.61 10.68 47 62400 360689 90205311
Folliculitis 119.27 10.68 5 62442 204348 90361652
Suicide attempt 119.03 10.68 198 62249 75201 90490799
Cholecystitis chronic 117.01 10.68 77 62370 9749 90556251
Drug intolerance 116.87 10.68 83 62364 447508 90118492
Treatment failure 115.69 10.68 33 62414 303895 90262105
Toxicity to various agents 109.40 10.68 440 62007 287406 90278594
Wound 107.98 10.68 37 62410 302943 90263057
Infusion related reaction 107.87 10.68 78 62369 416702 90149298
Viral test positive 105.41 10.68 32 62415 611 90565389
Impaired healing 104.06 10.68 18 62429 234181 90331819
General physical health deterioration 96.47 10.68 63 62384 355052 90210948
Therapeutic product effect decreased 93.67 10.68 37 62410 277534 90288466
Pneumonia haemophilus 92.79 10.68 36 62411 1467 90564533
Rheumatoid arthritis 87.29 10.68 73 62374 362541 90203459
Sinus tachycardia 84.06 10.68 101 62346 28412 90537588
Vomiting 81.03 10.68 864 61583 787429 89778571
Tongue biting 80.62 10.68 36 62411 2097 90563903
Type 2 diabetes mellitus 79.31 10.68 21 62426 203223 90362777
Loss of consciousness 78.82 10.68 244 62203 139994 90426006
Liver injury 73.83 10.68 14 62433 170553 90395447
Lower respiratory tract infection 72.89 10.68 41 62406 250618 90315382
Mouth haemorrhage 71.82 10.68 54 62393 8447 90557553
C-reactive protein increased 68.42 10.68 20 62427 181369 90384631
Product use issue 67.15 10.68 77 62370 329842 90236158
Psoriatic arthropathy 66.89 10.68 37 62410 228298 90337702
Abdominal discomfort 66.24 10.68 144 62303 477184 90088816
Nausea 66.13 10.68 1102 61345 1109214 89456786
Ill-defined disorder 65.11 10.68 23 62424 184868 90381132
Blood cholesterol increased 63.45 10.68 32 62415 207980 90358020
Nasopharyngitis 63.19 10.68 115 62332 406989 90159011
Off label use 62.69 10.68 474 61973 1101778 89464222
Swelling 61.87 10.68 122 62325 418936 90147064
Alopecia 61.02 10.68 159 62288 494912 90071088
Suicidal ideation 60.96 10.68 148 62299 73707 90492293
Snoring 60.62 10.68 40 62407 5086 90560914
Lethargy 60.32 10.68 134 62313 63005 90502995
Mobility decreased 59.66 10.68 51 62396 250683 90315317
Joint range of motion decreased 58.98 10.68 11 62436 135632 90430368
Fatigue 58.62 10.68 1117 61330 1152906 89413094
Hypercholesterolaemia 57.13 10.68 3 62444 100889 90465111
Irritable bowel syndrome 56.03 10.68 37 62410 207411 90358589
Muscle twitching 55.98 10.68 76 62371 24126 90541874
Lip dry 54.17 10.68 4 62443 100951 90465049
Seizure 52.17 10.68 226 62221 152403 90413597
Incoherent 52.08 10.68 36 62411 4941 90561059
Migraine 51.95 10.68 264 62183 190128 90375872
Blister 51.35 10.68 60 62387 254938 90311062
Mast cell activation syndrome 51.13 10.68 24 62423 1570 90564430
Mental status changes 51.01 10.68 102 62345 44577 90521423
Emotional distress 50.92 10.68 91 62356 36571 90529429
Bursitis 50.60 10.68 14 62433 131640 90434360
Hypersensitivity 50.13 10.68 154 62293 454523 90111477
Drug hypersensitivity 49.75 10.68 513 61934 463096 90102904
Therapeutic product effect incomplete 49.17 10.68 37 62410 193859 90372141
Formication 48.60 10.68 34 62413 4757 90561243
Stomatitis 47.80 10.68 72 62375 274626 90291374
Serotonin syndrome 47.53 10.68 90 62357 37797 90528203
Facet joint syndrome 47.28 10.68 6 62441 98383 90467617
Discomfort 46.68 10.68 73 62374 274262 90291738
Rash 45.79 10.68 341 62106 795759 89770241
Opisthotonus 45.72 10.68 15 62432 372 90565628
Peripheral swelling 44.76 10.68 141 62306 412965 90153035
Pulmonary haemorrhage neonatal 44.76 10.68 10 62437 51 90565949
Pulmonary fibrosis 44.08 10.68 10 62437 107493 90458507
Grip strength decreased 43.63 10.68 6 62441 92570 90473430
Wound infection 43.43 10.68 10 62437 106392 90459608
Illness 42.72 10.68 139 62308 81830 90484170
Deep vein thrombosis 42.14 10.68 149 62298 91471 90474529
Fibromyalgia 42.09 10.68 48 62399 206221 90359779
Tremor 41.50 10.68 212 62235 152961 90413039
Lung disorder 41.46 10.68 26 62421 149857 90416143
Electrocardiogram QT prolonged 40.62 10.68 126 62321 72330 90493670
Inflammation 40.46 10.68 38 62409 178554 90387446
Red blood cell sedimentation rate increased 39.77 10.68 5 62442 82590 90483410
Tongue injury 39.36 10.68 15 62432 582 90565418
Gastrointestinal disorder 39.35 10.68 73 62374 256614 90309386
Peripheral venous disease 38.25 10.68 6 62441 83915 90482085
Anaphylactic reaction 37.42 10.68 139 62308 87385 90478615
Electrocardiogram QRS complex shortened 36.86 10.68 14 62433 538 90565462
Dehydration 36.35 10.68 244 62203 194203 90371797
Congenital tricuspid valve incompetence 35.96 10.68 10 62437 138 90565862
Cholelithiasis 35.87 10.68 98 62349 52408 90513592
Hereditary angioedema 35.84 10.68 38 62409 9327 90556673
Sciatica 35.02 10.68 13 62434 101369 90464631
Biliary dyskinesia 34.98 10.68 22 62425 2577 90563423
Musculoskeletal pain 34.78 10.68 40 62407 171211 90394789
Neonatal hypotension 34.71 10.68 10 62437 158 90565842
Arthralgia 34.32 10.68 357 62090 778165 89787835
Gallbladder injury 33.86 10.68 17 62430 1289 90564711
Musculoskeletal stiffness 32.96 10.68 100 62347 296432 90269568
Accidental overdose 31.62 10.68 64 62383 28209 90537791
Craniofacial fracture 31.50 10.68 12 62435 465 90565535
Hip arthroplasty 31.42 10.68 7 62440 76201 90489799
Maternal exposure during pregnancy 31.05 10.68 135 62312 359928 90206072
Constipation 30.37 10.68 311 62136 280084 90285916
Gallbladder disorder 29.90 10.68 51 62396 19752 90546248
Respiratory disorder neonatal 29.89 10.68 16 62431 1385 90564615
Poor feeding infant 29.89 10.68 12 62435 536 90565464
Prescribed overdose 29.78 10.68 15 62432 97610 90468390
Blood creatine phosphokinase 29.39 10.68 9 62438 177 90565823
Impaired gastric emptying 29.28 10.68 40 62407 12769 90553231
Newborn persistent pulmonary hypertension 29.06 10.68 10 62437 288 90565712
Restlessness 28.85 10.68 71 62376 35649 90530351
Neonatal respiratory failure 28.37 10.68 10 62437 310 90565690
Prescription drug used without a prescription 28.22 10.68 21 62426 3234 90562766
Obsessive-compulsive disorder 28.20 10.68 24 62423 4480 90561520
Intestinal obstruction 28.10 10.68 72 62375 37059 90528941
Ataxia 27.95 10.68 47 62400 17995 90548005
Abdominal pain 27.25 10.68 403 62044 395318 90170682
Pre-existing condition improved 26.24 10.68 32 62415 9137 90556863
Foetal exposure during pregnancy 26.21 10.68 77 62370 42898 90523102
Chills 26.10 10.68 168 62279 131813 90434187
Paranoia 26.08 10.68 38 62409 12870 90553130
Neutrophil count decreased 26.04 10.68 108 62339 71424 90494576
Pupillary reflex impaired 25.67 10.68 18 62429 2527 90563473
Intentional product use issue 25.65 10.68 71 62376 216821 90349179
Obesity 25.64 10.68 21 62426 105486 90460514
Skin warm 25.61 10.68 29 62418 7658 90558342
Miosis 25.38 10.68 32 62415 9452 90556548
Wheezing 25.24 10.68 82 62365 237998 90328002
Appetite disorder 24.73 10.68 31 62416 9102 90556898
Impaired quality of life 24.25 10.68 51 62396 23093 90542907
Pharyngeal swelling 24.18 10.68 32 62415 9912 90556088
Completed suicide 24.15 10.68 177 62270 144881 90421119
Product administration interrupted 24.13 10.68 36 62411 12456 90553544
Atrial septal defect 23.99 10.68 29 62418 8205 90557795
Infection 23.77 10.68 149 62298 361945 90204055
Hyperreflexia 23.70 10.68 26 62421 6631 90559369
Prescribed underdose 23.68 10.68 11 62436 75008 90490992
Dysphoria 23.60 10.68 25 62422 6129 90559871
Feeling abnormal 23.39 10.68 196 62251 167039 90398961
Upper respiratory tract infection 23.36 10.68 160 62287 128158 90437842
COVID-19 23.15 10.68 197 62250 168646 90397354
Heart rate 23.13 10.68 8 62439 234 90565766
Autoimmune disorder 23.10 10.68 12 62435 76732 90489268
Blepharospasm 23.05 10.68 5 62442 55440 90510560
Respiratory failure 22.96 10.68 150 62297 118268 90447732
Neuroleptic malignant syndrome 22.95 10.68 39 62408 15057 90550943
Hepatitis 22.92 10.68 10 62437 70729 90495271
Gait inability 22.13 10.68 42 62405 146414 90419586
Mental disorder 21.75 10.68 60 62387 32258 90533742
Exostosis 21.67 10.68 5 62442 53129 90512871
Pre-eclampsia 21.57 10.68 32 62415 11016 90554984
Hypokalaemia 21.26 10.68 159 62288 130957 90435043
Night sweats 21.19 10.68 35 62412 128731 90437269
Adverse event 21.16 10.68 30 62417 117388 90448612
Liver disorder 20.87 10.68 32 62415 121237 90444763
Lymphocyte count decreased 20.62 10.68 62 62385 34988 90531012
Urinary retention 20.56 10.68 65 62382 37679 90528321
Epilepsy 20.43 10.68 16 62431 82190 90483810
Fear 20.25 10.68 39 62408 16583 90549417
Osteoarthritis 19.66 10.68 69 62378 195661 90370339
Dysarthria 19.62 10.68 82 62365 54400 90511600
Drug abuse 19.58 10.68 110 62337 82237 90483763
Drug-induced liver injury 19.54 10.68 20 62427 90298 90475702
Accidental death 19.54 10.68 14 62433 2034 90563966
Uterine perforation 19.44 10.68 25 62422 7529 90558471
Anhedonia 19.35 10.68 31 62416 11400 90554600
White blood cell count decreased 19.35 10.68 188 62259 166921 90399079
Lupus-like syndrome 19.13 10.68 5 62442 48841 90517159
Therapy non-responder 19.11 10.68 41 62406 136663 90429337
Urticaria 18.85 10.68 132 62315 312602 90253398
Haemorrhagic diathesis 18.67 10.68 21 62426 5503 90560497
Retching 18.67 10.68 41 62406 19118 90546882
Knee arthroplasty 18.48 10.68 18 62429 83164 90482836
Acute lung injury 18.47 10.68 12 62435 1486 90564514
Oral pain 18.46 10.68 57 62390 32626 90533374
Cyanosis neonatal 18.43 10.68 8 62439 435 90565565
Fear of falling 18.23 10.68 9 62438 658 90565342
Arthritis 18.17 10.68 57 62390 167258 90398742
Photophobia 17.95 10.68 43 62404 21226 90544774
Attention-seeking behaviour 17.78 10.68 5 62442 72 90565928
Pulmonary embolism 17.59 10.68 152 62295 130668 90435332
Weight increased 17.41 10.68 194 62253 417733 90148267
Sepsis 17.38 10.68 195 62252 179619 90386381
Lower limb fracture 17.10 10.68 20 62427 84993 90481007
Nephrolithiasis 17.00 10.68 73 62374 49012 90516988
Psychomotor hyperactivity 16.77 10.68 31 62416 12782 90553218
Nail disorder 16.67 10.68 10 62437 59057 90506943
Bronchoalveolar lavage abnormal 16.66 10.68 6 62441 198 90565802
Somnambulism 16.64 10.68 21 62426 6207 90559793
Blood potassium decreased 16.54 10.68 71 62376 47656 90518344
Sitting disability 16.52 10.68 7 62440 359 90565641
Dysphagia 16.45 10.68 133 62314 112145 90453855
pH body fluid increased 16.30 10.68 3 62444 4 90565996
Intestinal ischaemia 16.30 10.68 25 62422 8858 90557142
Thinking abnormal 16.13 10.68 29 62418 11703 90554297
Long QT syndrome congenital 15.76 10.68 5 62442 111 90565889
Adverse drug reaction 15.50 10.68 36 62411 116665 90449335
Live birth 15.49 10.68 19 62428 79088 90486912
Suicidal behaviour 15.49 10.68 14 62433 2830 90563170
Drug withdrawal syndrome 15.22 10.68 49 62398 28674 90537326
Liver function test increased 14.98 10.68 22 62425 84833 90481167
Cholecystitis 14.97 10.68 35 62412 17005 90548995
Blood pressure systolic increased 14.95 10.68 11 62436 58334 90507666
Condition aggravated 14.95 10.68 305 62142 595240 89970760
Wrong patient received product 14.91 10.68 15 62432 3462 90562538
Dependence 14.86 10.68 12 62435 2083 90563917
Patient uncooperative 14.73 10.68 6 62441 278 90565722
Macular degeneration 14.66 10.68 4 62443 37966 90528034
Heart rate increased 14.57 10.68 130 62317 112772 90453228
Prolonged rupture of membranes 14.46 10.68 4 62443 54 90565946
Mental impairment 14.32 10.68 34 62413 16686 90549314
Onychomycosis 14.31 10.68 4 62443 37372 90528628
Neuralgia 14.28 10.68 51 62396 31449 90534551
Surgery 14.21 10.68 65 62382 44822 90521178
Streptococcal endocarditis 14.18 10.68 5 62442 155 90565845
Onychomadesis 14.13 10.68 7 62440 45991 90520009
Cardiac septal defect 14.09 10.68 8 62439 777 90565223
Substance abuse 14.08 10.68 18 62429 5388 90560612
Ventricular septal defect 14.08 10.68 18 62429 5389 90560611
Arthritis infective 13.98 10.68 22 62425 7970 90558030
Catatonia 13.98 10.68 19 62428 6037 90559963
Fear of disease 13.88 10.68 10 62437 1466 90564534
Small intestinal obstruction 13.87 10.68 39 62408 21195 90544805
Tardive dyskinesia 13.75 10.68 26 62421 10904 90555096
Aggression 13.69 10.68 45 62402 26623 90539377
Vasoplegia syndrome 13.68 10.68 13 62434 2801 90563199
Tic 13.67 10.68 11 62436 1900 90564100
Finger deformity 13.60 10.68 3 62444 32894 90533106
Muscular weakness 13.57 10.68 85 62362 206581 90359419
Fallot's tetralogy 13.50 10.68 4 62443 70 90565930
Osteoporosis 13.45 10.68 29 62418 96502 90469498
Blastocystis infection 13.40 10.68 4 62443 72 90565928
Joint dislocation 13.37 10.68 7 62440 44575 90521425
Neonatal tachycardia 13.32 10.68 3 62444 16 90565984
Walking aid user 13.23 10.68 4 62443 35502 90530498
Depression 13.14 10.68 285 62162 300316 90265684
Transverse sinus thrombosis 13.03 10.68 7 62440 610 90565390
Oedema 12.83 10.68 83 62364 200212 90365788
Major depression 12.78 10.68 24 62423 10011 90555989
Oropharyngeal swelling 12.77 10.68 8 62439 930 90565070
Gestational hypertension 12.75 10.68 13 62434 3049 90562951
Drug-disease interaction 12.68 10.68 8 62439 942 90565058
Post concussion syndrome 12.61 10.68 7 62440 651 90565349
Thyroiditis 12.59 10.68 14 62433 3623 90562377
Ventricular extrasystoles 12.51 10.68 28 62419 13222 90552778
Product use in unapproved indication 12.49 10.68 160 62287 336076 90229924
Withdrawal syndrome 12.46 10.68 39 62408 22485 90543515
Laryngitis 12.46 10.68 10 62437 50743 90515257
Ileus 12.43 10.68 32 62415 16514 90549486
Cholecystectomy 12.43 10.68 26 62421 11729 90554271
Colitis ulcerative 12.31 10.68 14 62433 60252 90505748
Product dose omission issue 12.25 10.68 275 62172 291412 90274588
Gastritis 12.15 10.68 59 62388 41694 90524306
Bruxism 12.12 10.68 15 62432 4348 90561652
Foot deformity 12.03 10.68 14 62433 59637 90506363
Infantile haemangioma 12.01 10.68 4 62443 104 90565896
Jaw clicking 11.94 10.68 4 62443 106 90565894
Hypopnoea 11.93 10.68 15 62432 4416 90561584
Neonatal hypoxia 11.93 10.68 7 62440 724 90565276
Arteriovenous fistula thrombosis 11.77 10.68 5 62442 258 90565742
Vision blurred 11.76 10.68 122 62325 110171 90455829
Tenderness 11.76 10.68 43 62404 26825 90539175
Therapeutic response decreased 11.66 10.68 28 62419 89701 90476299
Patent ductus arteriosus 11.57 10.68 15 62432 4554 90561446
Postpartum haemorrhage 11.49 10.68 11 62436 2390 90563610
Sports injury 11.41 10.68 3 62444 33 90565967
Anion gap 11.34 10.68 8 62439 1134 90564866
Depressive symptom 11.33 10.68 16 62431 5269 90560731
Crying 11.18 10.68 41 62406 25604 90540396
Selective eating disorder 10.97 10.68 10 62437 2043 90563957
Back pain 10.91 10.68 291 62156 316884 90249116
Post-traumatic stress disorder 10.86 10.68 18 62429 6810 90559190
Frequent bowel movements 10.81 10.68 14 62433 56921 90509079
Coeliac disease 10.69 10.68 9 62438 44601 90521399
Cardiac arrest 10.68 10.68 115 62332 104820 90461180

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
Intentional self-injury 2237.15 12.48 659 22757 14543 42583376
Intentional overdose 1751.54 12.48 751 22665 50705 42547214
Akathisia 163.58 12.48 90 23326 10361 42587558
Depressed level of consciousness 148.12 12.48 156 23260 47814 42550105
Tachycardia 100.86 12.48 191 23225 100896 42497023
Sinus tachycardia 63.39 12.48 67 23349 20586 42577333
Dystonia 63.19 12.48 54 23362 12736 42585183
Neuroleptic malignant syndrome 57.78 12.48 65 23351 21407 42576512
Somnolence 52.81 12.48 184 23232 140921 42456998
Mydriasis 49.50 12.48 40 23376 8730 42589189
Drug ineffective 47.77 12.48 182 23234 630015 41967904
Lymphocyte count decreased 47.38 12.48 67 23349 27742 42570177
Loss of consciousness 42.24 12.48 129 23287 92225 42505694
Vomiting 38.78 12.48 282 23134 289441 42308478
Poor feeding infant 37.65 12.48 15 23401 827 42597092
Drug dependence 35.39 12.48 60 23356 29034 42568885
Consciousness fluctuating 34.29 12.48 16 23400 1299 42596620
Dehiscence 34.17 12.48 13 23403 633 42597286
Schizophrenia 33.75 12.48 35 23381 10515 42587404
Sedation 33.37 12.48 60 23356 30415 42567504
Dysarthria 33.36 12.48 70 23346 39737 42558182
Autoscopy 32.48 12.48 10 23406 254 42597665
Slow speech 32.44 12.48 17 23399 1773 42596146
Gas poisoning 32.40 12.48 8 23408 86 42597833
Red blood cell sedimentation rate decreased 32.08 12.48 10 23406 265 42597654
Hallucination 31.78 12.48 86 23330 57421 42540498
Agitation 30.49 12.48 91 23325 64223 42533696
Neutrophil count decreased 30.32 12.48 90 23326 63325 42534594
Neglect of personal appearance 29.16 12.48 10 23406 360 42597559
Hypoalbuminaemia 28.67 12.48 39 23377 15571 42582348
Foetal exposure during pregnancy 28.42 12.48 73 23343 47238 42550681
White blood cell count decreased 28.35 12.48 128 23288 110268 42487651
Tardive dyskinesia 27.79 12.48 26 23390 6898 42591021
Mental impairment 27.67 12.48 34 23382 12283 42585636
Drug hypersensitivity 27.62 12.48 118 23298 99271 42498648
Antidepressant therapy 27.05 12.48 5 23411 10 42597909
Psychomotor hyperactivity 25.84 12.48 31 23385 10927 42586992
Lethargy 24.78 12.48 69 23347 46821 42551098
Eosinophil count decreased 23.84 12.48 18 23398 3558 42594361
Blood prolactin increased 23.39 12.48 15 23401 2283 42595636
Exposure during pregnancy 23.20 12.48 26 23390 8522 42589397
Drug use disorder 22.37 12.48 28 23388 10305 42587614
Middle ear inflammation 21.99 12.48 7 23409 199 42597720
General symptom 21.80 12.48 11 23405 1060 42596859
Respiratory depression 21.75 12.48 38 23378 18830 42579089
Eating disorder 21.74 12.48 27 23389 9858 42588061
Anxiety 21.69 12.48 125 23291 118435 42479484
Extrapyramidal disorder 21.50 12.48 35 23381 16377 42581542
Overdose 21.27 12.48 114 23302 105150 42492769
Multiple organ dysfunction syndrome 20.63 12.48 14 23402 97021 42500898
Coagulation factor VIII level decreased 20.40 12.48 5 23411 52 42597867
Methaemoglobinaemia 20.00 12.48 20 23396 5754 42592165
Patent ductus arteriosus 19.92 12.48 16 23400 3460 42594459
Condition aggravated 19.82 12.48 75 23341 260679 42337240
Fatigue 19.64 12.48 342 23074 435299 42162620
Suicidal ideation 19.02 12.48 64 23352 48097 42549822
Aggression 18.61 12.48 60 23356 44103 42553816
Body temperature increased 18.47 12.48 37 23379 20321 42577598
Drug withdrawal syndrome neonatal 18.38 12.48 17 23399 4444 42593475
Strabismus 18.33 12.48 13 23403 2335 42595584
Hyperkalaemia 17.93 12.48 11 23405 80447 42517472
Labelled drug-drug interaction medication error 17.46 12.48 31 23385 15551 42582368
Depressed mood 17.17 12.48 39 23377 23345 42574574
Jaundice neonatal 16.86 12.48 12 23404 2167 42595752
Tracheobronchitis 16.74 12.48 10 23406 1343 42596576
Off label use 16.65 12.48 249 23167 638086 41959833
Upper respiratory tract irritation 16.65 12.48 4 23412 38 42597881
Atrial septal defect 16.42 12.48 21 23395 7898 42590021
Acute kidney injury 16.11 12.48 127 23289 367210 42230709
Interstitial lung disease 15.78 12.48 12 23404 78450 42519469
Exposure via breast milk 15.49 12.48 12 23404 2465 42595454
Delusion of grandeur 15.46 12.48 11 23405 1985 42595934
Congenital aortic valve stenosis 15.39 12.48 5 23411 152 42597767
Electrocardiogram high voltage 15.37 12.48 3 23413 9 42597910
Obsessive thoughts 15.13 12.48 8 23408 850 42597069
Delusion 14.85 12.48 28 23388 14706 42583213
Gallbladder enlargement 14.71 12.48 9 23407 1262 42596657
Mucosal haemorrhage 14.18 12.48 10 23406 1780 42596139
Suicide attempt 13.78 12.48 56 23360 46044 42551875
Blood osmolarity increased 13.65 12.48 6 23410 424 42597495
Failure to thrive 13.59 12.48 21 23395 9401 42588518
Psychotic disorder 13.52 12.48 41 23375 29167 42568752
Formication 13.00 12.48 10 23406 2031 42595888
Breath holding 12.83 12.48 4 23412 106 42597813
Hyperlactacidaemia 12.71 12.48 14 23402 4502 42593417
Platelet count decreased 12.67 12.48 124 23292 138457 42459462
Postmortem blood drug level increased 12.54 12.48 6 23410 515 42597404

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 5900.50 11.05 1749 65093 35680 110486777
Intentional overdose 4491.68 11.05 1984 64858 130517 110391940
Akathisia 598.84 11.05 263 66579 16850 110505607
Depressed level of consciousness 390.80 11.05 407 66435 111871 110410586
Tachycardia 389.70 11.05 576 66266 226069 110296388
Mydriasis 211.54 11.05 144 66698 22013 110500444
Hallucination 167.21 11.05 253 66589 101179 110421278
Synovitis 150.83 11.05 3 66839 274089 110248368
Human rhinovirus test positive 139.44 11.05 45 66797 1212 110521245
Respiratory syncytial virus test positive 135.73 11.05 46 66796 1448 110521009
Somnolence 133.20 11.05 439 66403 297010 110225447
Suicide attempt 120.83 11.05 221 66621 103173 110419284
Hand deformity 117.84 11.05 3 66839 218503 110303954
Drug ineffective 116.01 11.05 500 66342 1520040 109002417
Anxiety 113.68 11.05 461 66381 344617 110177840
Cholecystitis chronic 113.33 11.05 71 66771 9429 110513028
Agitation 109.28 11.05 223 66619 112828 110409629
Sinus tachycardia 106.58 11.05 133 66709 44360 110478097
Toxicity to various agents 103.98 11.05 568 66274 479987 110042470
Viral test positive 103.83 11.05 33 66809 845 110521612
Vomiting 103.01 11.05 918 65924 909757 109612700
Pericarditis 96.71 11.05 10 66832 219104 110303353
Glossodynia 93.32 11.05 12 66830 221992 110300465
Helicobacter infection 89.56 11.05 5 66837 181872 110340585
Pneumonia haemophilus 86.21 11.05 39 66803 2676 110519781
Arthropathy 86.11 11.05 33 66809 287489 110234968
Contraindicated product administered 82.19 11.05 24 66818 248243 110274214
Folliculitis 81.36 11.05 5 66837 167648 110354809
Lymphocyte count decreased 80.76 11.05 133 66709 57110 110465347
Systemic lupus erythematosus 79.88 11.05 27 66815 254311 110268146
Loss of consciousness 77.54 11.05 278 66564 196028 110326429
Impaired healing 77.21 11.05 13 66829 196704 110325753
Tongue biting 77.13 11.05 37 66805 2902 110519555
Joint swelling 76.58 11.05 93 66749 442752 110079705
Off label use 72.99 11.05 570 66272 1499615 109022842
Neutrophil count decreased 72.51 11.05 198 66644 120743 110401714
Neuroleptic malignant syndrome 70.91 11.05 95 66747 33964 110488493
Fatigue 66.57 11.05 1067 65775 1214891 109307566
Drug intolerance 66.51 11.05 89 66753 406423 110116034
Hepatic enzyme increased 64.88 11.05 59 66783 320833 110201624
Nausea 64.55 11.05 1076 65766 1234614 109287843
Drug hypersensitivity 62.53 11.05 479 66363 453611 110068846
Therapeutic product effect decreased 62.38 11.05 35 66807 244281 110278176
Formication 61.87 11.05 40 66802 5608 110516849
Serotonin syndrome 61.11 11.05 120 66722 59033 110463424
Treatment failure 60.93 11.05 47 66795 277187 110245270
Mouth haemorrhage 60.08 11.05 56 66786 13432 110509025
Nasopharyngitis 58.94 11.05 92 66750 394269 110128188
Lethargy 57.89 11.05 155 66687 93421 110429036
General physical health deterioration 56.44 11.05 107 66735 425188 110097269
Rheumatoid arthritis 56.04 11.05 59 66783 299554 110222903
Mast cell activation syndrome 55.11 11.05 24 66818 1504 110520953
Wound 55.10 11.05 37 66805 234400 110288057
White blood cell count decreased 54.89 11.05 279 66563 229111 110293346
C-reactive protein increased 53.11 11.05 33 66809 217886 110304571
Dystonia 50.72 11.05 70 66772 25735 110496722
Type 2 diabetes mellitus 50.35 11.05 22 66820 177210 110345247
Joint range of motion decreased 50.20 11.05 7 66835 121825 110400632
Emotional distress 48.79 11.05 93 66749 44754 110477703
Lip dry 48.51 11.05 3 66839 100080 110422377
Opisthotonus 47.90 11.05 18 66824 768 110521689
Suicidal ideation 47.79 11.05 145 66697 93792 110428665
Inflammation 47.45 11.05 29 66813 193209 110329248
Bursitis 45.94 11.05 11 66831 129907 110392550
Irritable bowel syndrome 45.68 11.05 21 66821 164194 110358263
Ill-defined disorder 45.31 11.05 19 66823 156834 110365623
Psoriatic arthropathy 43.68 11.05 33 66809 196728 110325729
Mobility decreased 43.00 11.05 48 66794 237374 110285083
Lower respiratory tract infection 42.04 11.05 51 66791 243055 110279402
Snoring 42.03 11.05 34 66808 6750 110515707
Electrocardiogram QT prolonged 41.04 11.05 152 66690 108808 110413649
Infusion related reaction 40.67 11.05 108 66734 381054 110141403
Hypercholesterolaemia 40.45 11.05 4 66838 90833 110431624
Tongue injury 40.44 11.05 15 66827 617 110521840
Lung disorder 40.21 11.05 30 66812 180017 110342440
Therapeutic product effect incomplete 38.64 11.05 47 66795 223758 110298699
Tardive dyskinesia 38.10 11.05 44 66798 13535 110508922
Hypoalbuminaemia 37.78 11.05 65 66777 28909 110493548
Stomatitis 37.60 11.05 66 66776 270176 110252281
Dehydration 37.39 11.05 293 66549 279218 110243239
Mental status changes 37.32 11.05 116 66726 76006 110446451
Intentional product use issue 36.85 11.05 58 66784 247848 110274609
Biliary dyskinesia 36.41 11.05 21 66821 2400 110520057
Liver injury 36.34 11.05 23 66819 150390 110372067
Chills 36.33 11.05 218 66624 190362 110332095
Gallbladder injury 36.20 11.05 17 66825 1271 110521186
Incoherent 35.88 11.05 34 66808 8324 110514133
Anaphylactic reaction 35.43 11.05 150 66692 114150 110408307
Grip strength decreased 34.50 11.05 4 66838 80170 110442287
Musculoskeletal pain 34.25 11.05 36 66806 182987 110339470
Psychomotor hyperactivity 33.98 11.05 51 66791 20226 110502231
Muscle twitching 33.71 11.05 63 66779 29872 110492585
Condition aggravated 33.34 11.05 284 66558 734552 109787905
Abdominal discomfort 33.28 11.05 124 66718 393734 110128723
Fibromyalgia 32.68 11.05 33 66809 170876 110351581
Mental impairment 32.46 11.05 53 66789 22586 110499871
Upper respiratory tract infection 32.29 11.05 161 66681 131167 110391290
Deep vein thrombosis 31.95 11.05 168 66674 139719 110382738
Pulmonary fibrosis 31.73 11.05 11 66831 102031 110420426
Gas poisoning 31.39 11.05 8 66834 89 110522368
Alopecia 31.36 11.05 114 66728 364639 110157818
Red blood cell sedimentation rate increased 31.10 11.05 5 66837 78297 110444160
Seizure 30.76 11.05 234 66608 220951 110301506
Dysarthria 30.56 11.05 116 66726 84005 110438452
Electrocardiogram QRS complex shortened 29.97 11.05 13 66829 807 110521650
Peripheral swelling 29.87 11.05 134 66708 403900 110118557
Hepatitis 29.25 11.05 9 66833 90045 110432412
Product use issue 29.11 11.05 94 66748 311601 110210856
Drug dependence 29.08 11.05 81 66761 49939 110472518
Hypokalaemia 28.81 11.05 199 66643 182249 110340208
Craniofacial fracture 28.79 11.05 13 66829 888 110521569
Hereditary angioedema 28.77 11.05 28 66814 7086 110515371
Swelling 28.69 11.05 112 66730 350929 110171528
Cholelithiasis 28.67 11.05 94 66748 63328 110459129
Blister 28.59 11.05 59 66783 227317 110295140
Miosis 28.24 11.05 49 66793 21934 110500523
Hypersensitivity 28.09 11.05 137 66705 403861 110118596
Dehiscence 27.65 11.05 12 66830 746 110521711
Gallbladder disorder 27.18 11.05 47 66795 20982 110501475
Arthralgia 27.16 11.05 321 66521 779311 109743146
Neglect of personal appearance 27.13 11.05 10 66832 404 110522053
Product use in unapproved indication 27.07 11.05 159 66683 447218 110075239
Restlessness 26.90 11.05 85 66757 56174 110466283
Blood cholesterol increased 26.74 11.05 44 66798 184741 110337716
Impaired gastric emptying 26.07 11.05 36 66806 13239 110509218
Withdrawal syndrome 25.81 11.05 58 66784 31322 110491135
Sciatica 25.41 11.05 12 66830 92387 110430070
Drug abuse 25.40 11.05 189 66653 177222 110345235
Antidepressant therapy 25.39 11.05 5 66837 14 110522443
Blood creatine phosphokinase 25.15 11.05 9 66833 334 110522123
Prescription drug used without a prescription 24.83 11.05 23 66819 5473 110516984
Tremor 24.33 11.05 207 66635 202025 110320432
Arthritis 24.16 11.05 40 66802 167546 110354911
Uterine perforation 24.13 11.05 25 66817 6815 110515642
Hyperkalaemia 23.99 11.05 28 66814 135768 110386689
Rash 23.85 11.05 351 66491 820613 109701844
Paranoia 23.85 11.05 46 66796 22328 110500129
Hypocalcaemia 23.62 11.05 90 66752 65276 110457181
Dysphoria 23.59 11.05 24 66818 6404 110516053
Drug withdrawal syndrome 23.49 11.05 63 66779 37991 110484466
Hypoproteinaemia 23.29 11.05 23 66819 5922 110516535
Gastrointestinal disorder 23.26 11.05 72 66770 241880 110280577
Appetite disorder 23.06 11.05 29 66813 9740 110512717
Slow speech 22.90 11.05 18 66824 3430 110519027
Accidental overdose 22.69 11.05 76 66766 51758 110470699
Heart rate 22.66 11.05 8 66834 285 110522172
Pupillary reflex impaired 22.53 11.05 19 66823 3996 110518461
Blood pressure systolic increased 22.48 11.05 11 66831 82980 110439477
Thinking abnormal 22.46 11.05 36 66806 15104 110507353
Wheezing 22.44 11.05 79 66763 255151 110267306
Therapy non-responder 22.25 11.05 38 66804 157269 110365188
Platelet count decreased 22.25 11.05 225 66617 230218 110292239
Epilepsy 21.98 11.05 17 66825 100192 110422265
Cholestasis 21.77 11.05 6 66836 64512 110457945
Osteoarthritis 21.62 11.05 49 66793 182574 110339883
Drug resistance 21.51 11.05 4 66838 56370 110466087
Skin warm 21.30 11.05 27 66815 9143 110513314
Pharyngeal swelling 21.22 11.05 31 66811 12001 110510456
Extrapyramidal disorder 21.16 11.05 51 66791 28816 110493641
Urinary retention 20.48 11.05 90 66752 69593 110452864
Abdominal pain 20.46 11.05 429 66413 512560 110009897
Wound infection 20.37 11.05 17 66825 96448 110426009
Migraine 20.28 11.05 175 66667 171477 110350980
Oral pain 20.17 11.05 59 66783 37385 110485072
Aggression 20.16 11.05 80 66762 59130 110463327
Coagulation factor VIII level decreased 19.92 11.05 5 66837 52 110522405
Middle ear inflammation 19.92 11.05 7 66835 246 110522211
Weight increased 19.53 11.05 161 66681 419483 110102974
Wrong patient received product 19.36 11.05 22 66820 6652 110515805
Fear 19.22 11.05 43 66799 23150 110499307
Electrocardiogram high voltage 19.22 11.05 4 66838 16 110522441
Pancytopenia 19.02 11.05 64 66778 209549 110312908
Sedation 18.98 11.05 88 66754 69595 110452862
Urticaria 18.91 11.05 114 66728 318743 110203714
Obsessive thoughts 18.76 11.05 11 66831 1296 110521161
Acute kidney injury 18.67 11.05 271 66571 635159 109887298
Colitis ulcerative 18.45 11.05 12 66830 77351 110445106
Nail disorder 18.44 11.05 6 66836 57929 110464528
Obesity 18.32 11.05 25 66817 113326 110409131
Constipation 18.32 11.05 311 66531 357475 110164982
Illness 18.29 11.05 98 66744 82073 110440384
Pre-eclampsia 17.81 11.05 24 66818 8626 110513831
Prescribed overdose 17.80 11.05 16 66826 87565 110434892
Drug abuser 17.71 11.05 19 66823 5390 110517067
Musculoskeletal stiffness 17.69 11.05 98 66744 279724 110242733
Borderline personality disorder 17.67 11.05 10 66832 1102 110521355
Blepharospasm 16.90 11.05 6 66836 54845 110467612
Postmortem blood drug level increased 16.83 11.05 10 66832 1207 110521250
Fear of falling 16.68 11.05 9 66833 904 110521553
Respiratory arrest 16.15 11.05 74 66768 58225 110464232
Supraventricular extrasystoles 16.01 11.05 22 66820 8051 110514406
Red blood cell sedimentation rate decreased 15.99 11.05 10 66832 1324 110521133
Autoimmune disorder 15.83 11.05 10 66832 65473 110456984
Night sweats 15.81 11.05 36 66806 133947 110388510
Hip arthroplasty 15.73 11.05 7 66835 55806 110466651
Haemorrhagic diathesis 15.71 11.05 21 66821 7487 110514970
Dependence 15.49 11.05 13 66829 2716 110519741
Photophobia 15.24 11.05 42 66800 25729 110496728
Blood potassium decreased 15.23 11.05 69 66773 54045 110468412
Bradycardia 15.14 11.05 46 66796 155471 110366986
Intestinal obstruction 15.07 11.05 68 66774 53159 110469298
Prolonged rupture of membranes 15.05 11.05 4 66838 53 110522404
Feeling abnormal 14.91 11.05 171 66671 180540 110341917
Body temperature increased 14.83 11.05 69 66773 54644 110467813
Blood pressure fluctuation 14.82 11.05 14 66828 74810 110447647
Hyperreflexia 14.69 11.05 23 66819 9462 110512995
Liver disorder 14.63 11.05 41 66801 142202 110380255
Hallucination, auditory 14.61 11.05 42 66800 26355 110496102
Suicidal behaviour 14.58 11.05 14 66828 3483 110518974
Strabismus 14.58 11.05 14 66828 3485 110518972
Frequent bowel movements 14.56 11.05 13 66829 71377 110451080
Respiratory failure 14.43 11.05 196 66646 215136 110307321
Long QT syndrome congenital 14.39 11.05 5 66837 170 110522287
Reversible cerebral vasoconstriction syndrome 14.33 11.05 16 66826 4745 110517712
Catatonia 14.27 11.05 25 66817 11275 110511182
Gait inability 14.26 11.05 39 66803 136337 110386120
Discomfort 14.23 11.05 74 66768 214633 110307824
Overdose 14.14 11.05 209 66633 233585 110288872
COVID-19 14.02 11.05 217 66625 244843 110277614
Hypophosphataemia 13.95 11.05 48 66794 33134 110489323
Live birth 13.76 11.05 13 66829 69471 110452986
Angioedema 13.74 11.05 24 66818 98476 110423981
Mental disorder 13.68 11.05 53 66789 38738 110483719
Bronchoalveolar lavage abnormal 13.67 11.05 6 66836 383 110522074
Cytomegalovirus infection 13.60 11.05 8 66834 54436 110468021
Tubulointerstitial nephritis 13.52 11.05 8 66834 54276 110468181
Pneumococcal sepsis 13.52 11.05 11 66831 2201 110520256
Delusion of grandeur 13.31 11.05 11 66831 2249 110520208
Obsessive-compulsive disorder 13.27 11.05 19 66823 7222 110515235
Hyperuricaemia 13.25 11.05 28 66814 14503 110507954
Anhedonia 13.23 11.05 29 66813 15399 110507058
Compulsions 13.23 11.05 6 66836 414 110522043
Pulmonary congestion 13.20 11.05 45 66797 30921 110491536
Impaired quality of life 13.13 11.05 44 66798 29973 110492484
Ataxia 13.05 11.05 44 66798 30064 110492393
Blood prolactin increased 12.95 11.05 15 66827 4627 110517830
Lower limb fracture 12.81 11.05 16 66826 75332 110447125
Loss of personal independence in daily activities 12.80 11.05 47 66795 149973 110372484
Chest discomfort 12.80 11.05 161 66681 173687 110348770
Neutrophil count increased 12.76 11.05 48 66794 34604 110487853
Fibrin D dimer increased 12.72 11.05 22 66820 9823 110512634
Jaw clicking 12.68 11.05 4 66838 100 110522357
Surgery 12.65 11.05 54 66788 41229 110481228
Hypophagia 12.56 11.05 64 66778 52562 110469895
Methaemoglobinaemia 12.52 11.05 21 66821 9147 110513310
Dysphagia 12.51 11.05 145 66697 153455 110369002
Ventricular extrasystoles 12.51 11.05 36 66806 22605 110499852
Restless legs syndrome 12.51 11.05 38 66804 24588 110497869
Cholecystectomy 12.48 11.05 23 66819 10786 110511671
Transverse sinus thrombosis 12.37 11.05 7 66835 771 110521686
Respiratory depression 12.34 11.05 45 66797 31956 110490501
Substance use 12.33 11.05 11 66831 2495 110519962
Drug use disorder 12.26 11.05 31 66811 18043 110504414
Completed suicide 12.15 11.05 210 66632 242171 110280286
Gallbladder enlargement 12.07 11.05 10 66832 2052 110520405
Accidental death 12.03 11.05 15 66827 4994 110517463
Mucosal inflammation 12.03 11.05 25 66817 96116 110426341
Acute lung injury 11.99 11.05 12 66830 3139 110519318
Prescribed underdose 11.99 11.05 13 66829 65161 110457296
Streptococcal endocarditis 11.96 11.05 5 66837 283 110522174
Knee arthroplasty 11.89 11.05 13 66829 64935 110457522
Tenderness 11.87 11.05 42 66800 29395 110493062
Infection 11.87 11.05 151 66691 362049 110160408
Sleep disorder 11.78 11.05 71 66771 198573 110323884
Muscular weakness 11.70 11.05 95 66747 248373 110274084
Heart rate decreased 11.69 11.05 20 66822 82736 110439721
Lupus-like syndrome 11.68 11.05 5 66837 40787 110481670
Retching 11.52 11.05 35 66807 22647 110499810
Adverse event 11.46 11.05 31 66811 108778 110413679
Underdose 11.33 11.05 13 66829 63541 110458916
Gastritis 11.25 11.05 63 66779 53636 110468821
Depressed mood 11.22 11.05 69 66773 60740 110461717
Gastric ulcer 11.22 11.05 5 66837 39822 110482635
Dental cyst 11.20 11.05 3 66839 41 110522416
Exostosis 11.13 11.05 7 66835 45949 110476508

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pleural effusion 41.93 29.70 11 258 28 113656
Pulmonary haemorrhage neonatal 35.74 29.70 10 259 35 113649
Poor feeding infant 33.25 29.70 15 254 258 113426

Pharmacologic Action:

SourceCodeDescription
ATC D04AA10 DERMATOLOGICALS
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
Antihistamines for topical use
ATC R06AD02 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Phenothiazine derivatives
ATC R06AD52 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Phenothiazine derivatives
ATC V03AB05 VARIOUS
ALL OTHER THERAPEUTIC PRODUCTS
ALL OTHER THERAPEUTIC PRODUCTS
Antidotes
FDA CS M0016525 Phenothiazines
MeSH PA D000982 Antipruritics
MeSH PA D003879 Dermatologic Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018926 Anti-Allergic Agents
FDA EPC N0000175746 Phenothiazine
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:35717 sedative
CHEBI has role CHEBI:36333 local anaesthetic
CHEBI has role CHEBI:37955 H<small><sub>1</sub></small>-receptor antagonist
CHEBI has role CHEBI:50857 anti-allergic agent
CHEBI has role CHEBI:50919 antiemetic
CHEBI has role CHEBI:55324 gastrointestinal drug
CHEBI has role CHEBI:59683 antipruritic drug
CHEBI has role CHEBI:149553 anticoronaviral agent
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:176497 geroprotector

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

DiseaseRelationSNOMED_IDDOID
Vasomotor rhinitis indication 8229003 DOID:4730
Nausea and vomiting indication 16932000
General anesthesia indication 50697003
Sedation indication 72641008
Urticaria indication 126485001
Seasonal allergic rhinitis indication 367498001
Allergic conjunctivitis indication 473460002 DOID:11204




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.19 Basic
pKa2 3.55 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Histamine H1 receptor GPCR ANTAGONIST Ki 9.62 WOMBAT-PK CHEMBL
D(1A) dopamine receptor GPCR Ki 5.86 DRUG MATRIX
D(2) dopamine receptor GPCR Ki 6.61 WOMBAT-PK
Alpha-2A adrenergic receptor GPCR Ki 6.59 DRUG MATRIX
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 6.92 DRUG MATRIX
Sodium-dependent serotonin transporter Transporter IC50 5.12 CHEMBL
Sodium-dependent noradrenaline transporter Transporter Ki 5.38 DRUG MATRIX
5-hydroxytryptamine receptor 1A GPCR Ki 5.83 DRUG MATRIX
5-hydroxytryptamine receptor 2A GPCR Ki 6.77 WOMBAT-PK
5-hydroxytryptamine receptor 2B GPCR Ki 7.37 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 8.19 DRUG MATRIX
5-hydroxytryptamine receptor 6 GPCR Ki 5.95 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR WOMBAT-PK
Alpha-2B adrenergic receptor GPCR Ki 7.62 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 6.72 DRUG MATRIX
Histamine H2 receptor GPCR Ki 5.94 DRUG MATRIX
Histamine H4 receptor GPCR Ki 6.82 WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR Ki 8.48 DRUG MATRIX
Muscarinic acetylcholine receptor M2 GPCR Ki 7.92 DRUG MATRIX
Muscarinic acetylcholine receptor M3 GPCR Ki 8.38 DRUG MATRIX
Muscarinic acetylcholine receptor M4 GPCR Ki 8.98 DRUG MATRIX
Muscarinic acetylcholine receptor M5 GPCR Ki 8.48 DRUG MATRIX
Aldehyde oxidase Enzyme IC50 6.29 WOMBAT-PK
Alpha-2C adrenergic receptor GPCR Ki 6.45 DRUG MATRIX
Cytochrome P450 2D6 Enzyme Ki 5.42 WOMBAT-PK
Alpha-1D adrenergic receptor GPCR Ki 7.50 DRUG MATRIX
Cholinesterase Enzyme Ki 7.10 WOMBAT-PK
Voltage-dependent N-type calcium channel subunit alpha-1B Ion channel IC50 4.75 CHEMBL
Major prion protein Surface antigen EC50 5.10 CHEMBL
Solute carrier family 22 member 1 Transporter IC50 4.45 CHEMBL
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel IC50 5.16 CHEMBL
FAD-linked sulfhydryl oxidase ALR Enzyme AC50 6.44 CHEMBL
Calmodulin-1 Cytosolic other IC50 4.22 CHEMBL
5-hydroxytryptamine receptor 1A GPCR IC50 5.59 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 7.68 DRUG MATRIX
Histamine H1 receptor GPCR Ki 9 CHEMBL
Pleiotropic ABC efflux transporter of multiple drugs Transporter IC50 4.75 CHEMBL
Chloroquine resistance transporter Transporter IC50 4.07 CHEMBL
Calmodulin Cytosolic other Kd 4.30 CHEMBL
Alpha-1A adrenergic receptor GPCR IC50 7.10 CHEMBL

External reference:

IDSource
4019910 VUID
N0000147995 NUI
D00480 KEGG_DRUG
58-33-3 SECONDARY_CAS_RN
4017846 VANDF
4019910 VANDF
C0033405 UMLSCUI
CHEBI:8461 CHEBI
CHEMBL643 ChEMBL_ID
CHEMBL1200750 ChEMBL_ID
DB01069 DRUGBANK_ID
D011398 MESH_DESCRIPTOR_UI
4927 PUBCHEM_CID
7282 IUPHAR_LIGAND_ID
516 INN_ID
FF28EJQ494 UNII
142445 RXNORM
2141 MMSL
5367 MMSL
d00787 MMSL
001483 NDDF
004459 NDDF
14905007 SNOMEDCT_US
372871004 SNOMEDCT_US
8372007 SNOMEDCT_US
FF28EJQ494 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
PROMETHAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0116-4023 SYRUP 6.25 mg ORAL ANDA 25 sections
Promethazine Hydrochloride and Dextromethorphan Hydrobromide HUMAN PRESCRIPTION DRUG LABEL 2 0116-4024 SYRUP 6.25 mg ORAL ANDA 25 sections
Promethazine DM HUMAN PRESCRIPTION DRUG LABEL 2 0121-1070 SOLUTION 6.25 mg ORAL ANDA 23 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0121-1854 SOLUTION 6.25 mg ORAL ANDA 26 sections
PROMETHAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9940 INJECTION 25 mg INTRAMUSCULAR ANDA 12 sections
PROMETHAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9940 INJECTION 25 mg INTRAMUSCULAR ANDA 12 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0404-9941 INJECTION 25 mg INTRAMUSCULAR ANDA 12 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0404-9941 INJECTION 25 mg INTRAMUSCULAR ANDA 12 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0404-9942 INJECTION 50 mg INTRAMUSCULAR ANDA 12 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0404-9942 INJECTION 50 mg INTRAMUSCULAR ANDA 12 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0440-5195 TABLET 25 mg ORAL ANDA 11 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0440-8195 TABLET 25 mg ORAL ANDA 12 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-5307 TABLET 25 mg ORAL ANDA 24 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-5319 TABLET 50 mg ORAL ANDA 24 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8154 TABLET 25 mg ORAL ANDA 21 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-0928 INJECTION 25 mg INTRAMUSCULAR ANDA 25 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-0929 INJECTION 50 mg INTRAMUSCULAR ANDA 25 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-0948 INJECTION 25 mg INTRAMUSCULAR ANDA 25 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-0949 INJECTION 50 mg INTRAMUSCULAR ANDA 25 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-0955 INJECTION 25 mg INTRAMUSCULAR ANDA 25 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-0956 INJECTION 50 mg INTRAMUSCULAR ANDA 25 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-1495 INJECTION 25 mg INTRAMUSCULAR ANDA 25 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-1496 INJECTION 50 mg INTRAMUSCULAR ANDA 25 sections
PHENERGAN HUMAN PRESCRIPTION DRUG LABEL 1 0641-6082 INJECTION 25 mg INTRAMUSCULAR ANDA 25 sections
PHENERGAN HUMAN PRESCRIPTION DRUG LABEL 1 0641-6083 INJECTION 50 mg INTRAMUSCULAR ANDA 25 sections
PHENERGAN HUMAN PRESCRIPTION DRUG LABEL 1 0641-6084 INJECTION 25 mg INTRAMUSCULAR ANDA 26 sections
PHENERGAN HUMAN PRESCRIPTION DRUG LABEL 1 0641-6085 INJECTION 50 mg INTRAMUSCULAR ANDA 26 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-6208 INJECTION 25 mg INTRAMUSCULAR ANDA 25 sections
PROMETHEGAN HUMAN PRESCRIPTION DRUG LABEL 1 0713-0132 SUPPOSITORY 50 mg RECTAL ANDA 21 sections
PROMETHEGAN HUMAN PRESCRIPTION DRUG LABEL 1 0713-0526 SUPPOSITORY 25 mg RECTAL ANDA 21 sections