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

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 6677.07 10.13 2019 59356 21093 50522656
Intentional overdose 5455.80 10.13 2239 59136 60265 50483484
Akathisia 530.44 10.13 239 61136 7990 50535759
Tachycardia 464.40 10.13 588 60787 99175 50444574
Depressed level of consciousness 393.97 10.13 395 60980 51558 50492191
Cholecystitis chronic 296.50 10.13 170 61205 9499 50534250
Drug ineffective 278.75 10.13 353 61022 818980 49724769
Mydriasis 273.88 10.13 167 61208 10460 50533289
Anxiety 185.68 10.13 554 60821 177052 50366697
Contraindicated product administered 161.67 10.13 4 61371 148954 50394795
Hallucination 143.78 10.13 226 61149 46431 50497318
Synovitis 121.93 10.13 7 61368 123858 50419891
Somnolence 120.15 10.13 437 60938 154548 50389201
Drug intolerance 115.31 10.13 61 61314 219043 50324706
Poisoning 113.94 10.13 105 61270 12324 50531425
Treatment failure 111.28 10.13 17 61358 137620 50406129
Glossodynia 109.40 10.13 8 61367 115561 50428188
Agitation 104.38 10.13 212 61163 53172 50490577
Hand deformity 103.98 10.13 4 61371 100195 50443554
Joint swelling 103.89 10.13 87 61288 245199 50298550
Rheumatoid arthritis 99.96 10.13 61 61314 202489 50341260
Biliary dyskinesia 97.87 10.13 52 61323 2498 50541251
Injury 96.49 10.13 195 61180 48730 50495019
Off label use 95.16 10.13 279 61096 474147 50069602
Emotional distress 92.69 10.13 142 61233 28521 50515228
Gallbladder disorder 91.20 10.13 107 61268 16635 50527114
Arthropathy 89.06 10.13 40 61335 157866 50385883
Suicide attempt 86.75 10.13 193 61182 51539 50492210
Sinus tachycardia 85.40 10.13 117 61258 21237 50522512
Gallbladder injury 84.68 10.13 38 61337 1256 50542493
Vomiting 83.46 10.13 889 60486 459869 50083880
Therapeutic product effect decreased 82.32 10.13 31 61344 136019 50407730
Systemic lupus erythematosus 80.27 10.13 35 61340 140587 50403162
Migraine 75.82 10.13 232 61143 75048 50468701
Pericarditis 70.21 10.13 7 61368 78682 50465067
Abdominal discomfort 69.94 10.13 108 61267 231533 50312216
Cholelithiasis 68.59 10.13 146 61229 37827 50505922
Infusion related reaction 63.66 10.13 67 61308 169490 50374259
Rash 62.87 10.13 295 61080 437176 50106573
Nasopharyngitis 62.09 10.13 86 61289 192841 50350908
Alopecia 60.77 10.13 129 61246 244918 50298831
Snoring 59.79 10.13 42 61333 3342 50540407
Drug abuse 58.91 10.13 183 61192 59663 50484086
Toxicity to various agents 58.84 10.13 450 60925 212049 50331700
Product use issue 58.46 10.13 57 61318 149418 50394331
Incoherent 57.86 10.13 45 61330 4185 50539564
Wound 57.77 10.13 28 61347 105766 50437983
Hepatic enzyme increased 57.76 10.13 49 61326 137331 50406418
Respiratory arrest 57.25 10.13 118 61257 29891 50513858
Muscle twitching 54.96 10.13 80 61295 15351 50528398
Accidental overdose 51.21 10.13 88 61287 19445 50524304
Arthralgia 50.25 10.13 319 61056 438383 50105366
Loss of consciousness 48.94 10.13 253 61122 104100 50439649
Formication 48.17 10.13 38 61337 3608 50540141
Dependence 47.11 10.13 29 61346 1846 50541903
Therapeutic product effect incomplete 45.88 10.13 27 61348 91488 50452261
Lethargy 45.76 10.13 148 61227 49284 50494465
Peripheral swelling 45.72 10.13 115 61260 205821 50337928
Deep vein thrombosis 45.59 10.13 193 61182 73111 50470638
Pulmonary haemorrhage neonatal 45.56 10.13 10 61365 22 50543727
Abdominal pain 44.07 10.13 459 60916 235769 50307980
Opisthotonus 43.46 10.13 16 61359 313 50543436
Helicobacter infection 42.86 10.13 5 61370 49697 50494052
Drug hypersensitivity 42.79 10.13 479 60896 250531 50293218
Hereditary angioedema 40.50 10.13 41 61334 5401 50538348
Accidental death 38.86 10.13 25 61350 1719 50542030
C-reactive protein increased 38.78 10.13 16 61359 66458 50477291
Swelling 38.77 10.13 120 61255 200752 50342997
Lower respiratory tract infection 38.74 10.13 35 61340 95166 50448583
Pupillary reflex impaired 37.14 10.13 25 61350 1856 50541893
Hypersensitivity 37.11 10.13 135 61240 215026 50328723
Drug abuser 36.34 10.13 29 61346 2799 50540950
Serotonin syndrome 34.65 10.13 86 61289 24627 50519122
Impaired healing 34.40 10.13 21 61354 69765 50473984
Congenital tricuspid valve incompetence 34.05 10.13 10 61365 92 50543657
Mental status changes 33.02 10.13 108 61267 36164 50507585
Nausea 32.51 10.13 1100 60275 704298 49839451
Electrocardiogram QRS complex shortened 32.46 10.13 14 61361 420 50543329
Neonatal hypotension 32.28 10.13 10 61365 112 50543637
Cardiac failure 32.09 10.13 27 61348 76013 50467736
Dysarthria 31.95 10.13 109 61266 37294 50506455
Discomfort 31.28 10.13 52 61323 108328 50435421
Infection 30.82 10.13 107 61268 172847 50370902
Newborn persistent pulmonary hypertension 30.25 10.13 10 61365 140 50543609
Cardiac arrest 29.48 10.13 188 61187 83463 50460286
Suicidal ideation 29.30 10.13 139 61236 55246 50488503
Folliculitis 29.16 10.13 6 61369 39219 50504530
Maternal exposure during pregnancy 29.04 10.13 98 61277 159680 50384069
Cholecystitis 28.18 10.13 56 61319 13815 50529934
Drug screen positive 27.85 10.13 27 61348 3375 50540374
Neonatal respiratory failure 27.63 10.13 10 61365 186 50543563
Gallbladder hypofunction 26.85 10.13 13 61362 512 50543237
Depression 26.05 10.13 311 61064 165112 50378637
Gallbladder cholesterolosis 25.50 10.13 14 61361 718 50543031
Pulmonary embolism 25.15 10.13 210 61165 101494 50442255
General physical health deterioration 24.78 10.13 89 61286 142345 50401404
Mobility decreased 24.35 10.13 37 61338 79911 50463838
Drug reaction with eosinophilia and systemic symptoms 24.16 10.13 3 61372 28421 50515328
Biliary colic 23.24 10.13 24 61351 3235 50540514
Completed suicide 22.57 10.13 252 61123 131637 50412112
Exposure via ingestion 22.49 10.13 22 61353 2781 50540968
Renal impairment 22.10 10.13 36 61339 75625 50468124
Dehydration 22.01 10.13 282 61093 152167 50391582
Product use in unapproved indication 21.76 10.13 70 61305 115749 50428000
Fatigue 21.55 10.13 1056 60319 706545 49837204
Miosis 21.44 10.13 32 61343 6278 50537471
Atrial septal defect 21.32 10.13 32 61343 6309 50537440
Anhedonia 21.24 10.13 40 61335 9484 50534265
Musculoskeletal stiffness 20.59 10.13 83 61292 128398 50415351
Hip arthroplasty 20.01 10.13 6 61369 30423 50513326
Impaired gastric emptying 19.92 10.13 37 61338 8681 50535068
Cholesterosis 19.86 10.13 10 61365 429 50543320
Cough 19.80 10.13 192 61183 241072 50302677
Fear 19.73 10.13 50 61325 14499 50529250
Illness anxiety disorder 19.66 10.13 7 61368 124 50543625
Electrocardiogram QT prolonged 19.14 10.13 118 61257 51768 50491981
Coma blister 18.51 10.13 7 61368 148 50543601
Gastrointestinal disorder 18.51 10.13 56 61319 94400 50449349
Therapeutic response decreased 18.46 10.13 18 61357 47213 50496536
Differential white blood cell count abnormal 18.04 10.13 11 61364 688 50543061
Drug withdrawal syndrome 17.95 10.13 69 61306 25012 50518737
Stomatitis 17.84 10.13 63 61312 101281 50442468
Restlessness 17.80 10.13 69 61306 25104 50518645
Paranoia 17.78 10.13 39 61336 10309 50533440
Hyperreflexia 17.45 10.13 26 61349 5092 50538657
Ill-defined disorder 16.92 10.13 25 61350 54629 50489120
Cholestasis 16.72 10.13 5 61370 25396 50518353
Blastocystis infection 16.25 10.13 4 61371 17 50543732
Pupil fixed 15.98 10.13 14 61361 1538 50542211
Ventricular septal defect 15.94 10.13 22 61353 4019 50539730
Cardio-respiratory arrest 15.93 10.13 116 61259 53776 50489973
Cholecystectomy 15.91 10.13 35 61340 9268 50534481
Jaw clicking 15.89 10.13 4 61371 19 50543730
Blister 15.78 10.13 52 61323 85366 50458383
Seizure 15.74 10.13 215 61160 117659 50426090
Red blood cell sedimentation rate increased 15.72 10.13 8 61367 29408 50514341
Neutropenia 15.66 10.13 110 61265 147855 50395894
Vasoplegia syndrome 15.56 10.13 12 61363 1102 50542647
Condition aggravated 15.55 10.13 260 61115 296798 50246951
Fear of disease 15.48 10.13 11 61364 891 50542858
Mental disorder 15.33 10.13 60 61315 21931 50521818
Arthritis 15.20 10.13 54 61321 86667 50457082
Device expulsion 15.17 10.13 8 61367 28814 50514935
Tremor 15.10 10.13 209 61166 114694 50429055
Aggression 15.03 10.13 58 61317 21058 50522691
Melaena 14.82 10.13 7 61368 26857 50516892
Attention-seeking behaviour 14.81 10.13 5 61370 75 50543674
Blood pressure fluctuation 14.77 10.13 13 61362 35810 50507939
pH body fluid increased 14.61 10.13 3 61372 4 50543745
Unresponsive to stimuli 14.18 10.13 74 61301 30535 50513214
Loss of personal independence in daily activities 14.10 10.13 41 61334 70009 50473740
Respiratory rate decreased 13.91 10.13 18 61357 3090 50540659
Base excess increased 13.70 10.13 4 61371 36 50543713
Pancreatitis chronic 13.46 10.13 15 61360 2205 50541544
Respiratory rate increased 13.28 10.13 37 61338 11348 50532401
Acute lung injury 13.22 10.13 12 61363 1381 50542368
Fall 13.04 10.13 308 61067 334624 50209125
Finger amputation 12.84 10.13 8 61367 520 50543229
Cytomegalovirus infection 12.84 10.13 3 61372 17959 50525790
Jugular vein thrombosis 12.68 10.13 16 61359 2680 50541069
Postpartum haemorrhage 12.66 10.13 13 61362 1741 50542008
Pulmonary fibrosis 12.54 10.13 7 61368 24430 50519319
Hepatocellular injury 12.52 10.13 8 61367 25939 50517810
Osteoporosis 12.51 10.13 22 61353 44857 50498892
Psychotic disorder 12.46 10.13 56 61319 21756 50521993
Patent ductus arteriosus 12.45 10.13 19 61356 3801 50539948
Prolonged rupture of membranes 12.37 10.13 4 61371 52 50543697
Neonatal tachycardia 12.33 10.13 3 61372 12 50543737
Dyspnoea 12.32 10.13 541 60834 547067 49996682
Overdose 12.15 10.13 179 61196 99548 50444201
Acute kidney injury 12.12 10.13 199 61176 227859 50315890
Drug interaction 12.04 10.13 170 61205 199451 50344298
Drug resistance 12.03 10.13 4 61371 18985 50524764
Lentigo 12.01 10.13 6 61369 253 50543496
Uterine perforation 11.97 10.13 25 61350 6390 50537359
Herpes zoster 11.80 10.13 45 61330 70741 50473008
Intestinal obstruction 11.69 10.13 63 61312 26320 50517429
Hyperkinetic heart syndrome 11.63 10.13 3 61372 16 50543733
Knee arthroplasty 11.49 10.13 16 61359 35830 50507919
Hypophagia 11.47 10.13 65 61310 27663 50516086
Pickwickian syndrome 11.45 10.13 6 61369 280 50543469
Psoriatic arthropathy 11.43 10.13 25 61350 47007 50496742
Hypopnoea 11.41 10.13 14 61361 2279 50541470
Slow response to stimuli 11.36 10.13 9 61366 860 50542889
Cholecystitis acute 11.33 10.13 26 61349 7080 50536669
Patient uncooperative 11.32 10.13 5 61370 159 50543590
Arm amputation 11.19 10.13 3 61372 19 50543730
Ventricular extrasystoles 11.13 10.13 33 61342 10483 50533266
Nephrolithiasis 11.02 10.13 76 61299 34617 50509132
Therapy non-responder 10.91 10.13 29 61346 50993 50492756
Drug dependence 10.74 10.13 50 61325 19709 50524040
Fallot's tetralogy 10.74 10.13 4 61371 81 50543668
Respiratory disorder neonatal 10.73 10.13 9 61366 932 50542817
Blood potassium decreased 10.62 10.13 79 61296 36866 50506883
Scar 10.58 10.13 35 61340 11783 50531966
Visceral oedema 10.48 10.13 3 61372 25 50543724
Transverse sinus thrombosis 10.43 10.13 7 61368 517 50543232
Arteriovenous fistula thrombosis 10.37 10.13 5 61370 195 50543554
Radial pulse abnormal 10.27 10.13 3 61372 27 50543722
Pre-existing condition improved 10.27 10.13 25 61350 7072 50536677
Inflammation 10.27 10.13 35 61340 56877 50486872
Psychological trauma 10.25 10.13 9 61366 991 50542758
Basal cell carcinoma 10.22 10.13 8 61367 23348 50520401
Constipation 10.15 10.13 296 61079 185412 50358337
Gas gangrene 10.14 10.13 4 61371 95 50543654

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 2134.88 11.91 661 22840 11800 29539226
Intentional overdose 1684.22 11.91 748 22753 37780 29513246
Akathisia 152.69 11.91 84 23417 6658 29544368
Depressed level of consciousness 121.08 11.91 148 23353 36794 29514232
Tachycardia 93.68 11.91 189 23312 72221 29478805
Respiratory arrest 87.06 11.91 105 23396 25728 29525298
Sinus tachycardia 65.65 11.91 70 23431 14999 29536027
Mydriasis 60.25 11.91 45 23456 6040 29544986
Drug ineffective 57.08 11.91 128 23373 363042 29187984
Somnolence 55.08 11.91 182 23319 93773 29457253
Poisoning 53.70 11.91 52 23449 9941 29541085
Off label use 52.30 11.91 100 23401 300700 29250326
Vomiting 48.39 11.91 311 23190 211949 29339077
Agitation 46.19 11.91 116 23385 51188 29499838
Hallucination 40.14 11.91 101 23400 44611 29506415
Dysarthria 39.09 11.91 80 23421 30831 29520195
Loss of consciousness 38.60 11.91 138 23363 73918 29477108
Exposure during pregnancy 35.95 11.91 39 23462 8515 29542511
Consciousness fluctuating 32.96 11.91 16 23485 976 29550050
Neuroleptic malignant syndrome 32.24 11.91 51 23450 16097 29534929
Dystonia 31.80 11.91 39 23462 9710 29541316
Anxiety 30.12 11.91 141 23360 85224 29465802
Interstitial lung disease 29.82 11.91 5 23496 57713 29493313
Cardio-respiratory arrest 28.70 11.91 97 23404 50504 29500522
Dehydration 27.84 11.91 171 23330 114577 29436449
Lethargy 26.80 11.91 78 23423 37502 29513524
Failure to thrive 25.49 11.91 31 23470 7653 29543373
Cardiac arrest 24.30 11.91 133 23368 85458 29465568
General symptom 23.50 11.91 12 23489 816 29550210
Dextrocardia 23.11 11.91 7 23494 114 29550912
Confusional state 22.96 11.91 177 23324 127700 29423326
Foetal alcohol syndrome 21.86 11.91 7 23494 138 29550888
Drug withdrawal syndrome 20.93 11.91 45 23456 17939 29533087
Nausea 20.53 11.91 333 23168 288922 29262104
Nasopharyngitis 20.37 11.91 11 23490 59654 29491372
Opisthotonus 20.31 11.91 9 23492 445 29550581
Atrial septal defect 20.29 11.91 26 23475 6763 29544263
Drug hypersensitivity 19.88 11.91 107 23394 68299 29482727
Hepatic ischaemia 18.38 11.91 8 23493 379 29550647
Patent ductus arteriosus 18.16 11.91 17 23484 3114 29547912
General physical health deterioration 17.96 11.91 34 23467 102823 29448203
Exposure via ingestion 17.94 11.91 14 23487 2004 29549022
Obsessive thoughts 17.61 11.91 9 23492 613 29550413
Toxicity to various agents 17.14 11.91 212 23289 173449 29377577
Completed suicide 16.79 11.91 126 23375 90120 29460906
Cardiomegaly 16.64 11.91 35 23466 13741 29537285
Condition aggravated 16.63 11.91 60 23441 146235 29404791
Sedation 16.33 11.91 40 23461 17365 29533661
Fallot's tetralogy 16.22 11.91 6 23495 185 29550841
Acute kidney injury 16.21 11.91 134 23367 265133 29285893
Accidental overdose 16.04 11.91 40 23461 17553 29533473
Skin swelling 15.78 11.91 10 23491 1028 29549998
Therapeutic product effect incomplete 15.35 11.91 6 23495 39299 29511727
Product use in unapproved indication 14.92 11.91 29 23472 86846 29464180
Upper respiratory tract irritation 14.91 11.91 4 23497 41 29550985
Overdose 14.60 11.91 111 23390 79708 29471318
Psychotic disorder 14.27 11.91 42 23459 20312 29530714
Gallbladder enlargement 14.05 11.91 9 23492 942 29550084
Restlessness 13.94 11.91 44 23457 22101 29528925
Psychomotor hyperactivity 13.79 11.91 24 23477 8189 29542837
Fatigue 13.79 11.91 339 23162 316482 29234544
Pupil fixed 13.44 11.91 11 23490 1685 29549341
Renal impairment 13.24 11.91 28 23473 81305 29469721
Acute chest syndrome 13.20 11.91 6 23495 315 29550711
Ventricular septal defect 12.96 11.91 15 23486 3514 29547512
Loss of control of legs 12.95 11.91 7 23494 535 29550491
Labelled drug-drug interaction medication error 12.54 11.91 29 23472 12130 29538896
Unresponsive to stimuli 12.37 11.91 46 23455 25080 29525946
Mucosal haemorrhage 12.34 11.91 10 23491 1511 29549515
Cardiac failure 12.32 11.91 28 23473 79259 29471767
Snoring 12.24 11.91 13 23488 2771 29548255

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 5462.39 10.38 1740 61693 27304 64407995
Intentional overdose 4253.85 10.38 1968 61465 87976 64347323
Akathisia 557.28 10.38 257 63176 11253 64424046
Tachycardia 383.74 10.38 594 62839 148985 64286314
Depressed level of consciousness 352.01 10.38 417 63016 81019 64354280
Cholecystitis chronic 276.30 10.38 149 63284 9138 64426161
Mydriasis 228.62 10.38 158 63275 15154 64420145
Drug ineffective 190.81 10.38 335 63098 839912 63595387
Anxiety 177.84 10.38 519 62914 202130 64233169
Poisoning 174.70 10.38 156 63277 21723 64413576
Respiratory arrest 156.47 10.38 225 63208 52760 64382539
Hallucination 140.80 10.38 255 63178 72533 64362766
Off label use 138.23 10.38 258 63175 632548 63802751
Vomiting 113.14 10.38 926 62507 550191 63885108
Somnolence 111.83 10.38 446 62987 203199 64232100
Biliary dyskinesia 105.60 10.38 50 63383 2322 64432977
Sinus tachycardia 101.38 10.38 141 63292 32047 64403252
Agitation 100.22 10.38 249 63184 88118 64347181
Injury 95.60 10.38 186 63247 55806 64379493
Gallbladder injury 93.25 10.38 37 63396 1111 64434188
Gallbladder disorder 91.93 10.38 98 63335 16932 64418367
Emotional distress 90.62 10.38 142 63291 35896 64399403
Synovitis 84.08 10.38 3 63430 99087 64336212
Suicide attempt 82.53 10.38 202 63231 70805 64364494
Toxicity to various agents 76.65 10.38 615 62818 362898 64072401
Drug hypersensitivity 71.64 10.38 439 62994 237376 64197923
Drug abuse 68.68 10.38 285 63148 132089 64303210
Drug intolerance 62.13 10.38 56 63377 187936 64247363
Cardiac arrest 61.50 10.38 307 63126 153757 64281542
Nasopharyngitis 59.49 10.38 63 63370 196010 64239289
Opisthotonus 59.34 10.38 23 63410 648 64434651
Rheumatoid arthritis 59.16 10.38 45 63388 164249 64271050
Contraindicated product administered 54.44 10.38 19 63414 107810 64327489
Joint swelling 54.06 10.38 80 63353 215302 64219997
Lethargy 53.38 10.38 175 63258 72419 64362880
Accidental overdose 51.90 10.38 107 63326 33450 64401849
Treatment failure 51.82 10.38 25 63408 116791 64318508
Cholelithiasis 51.32 10.38 128 63305 45378 64389921
Nausea 49.71 10.38 1064 62369 784736 63650563
Hand deformity 49.69 10.38 3 63430 62768 64372531
Loss of consciousness 49.21 10.38 281 63152 148084 64287215
Migraine 48.71 10.38 154 63279 62523 64372776
Completed suicide 48.47 10.38 382 63051 224032 64211267
Drug abuser 47.52 10.38 42 63391 5766 64429533
Serotonin syndrome 46.96 10.38 113 63320 39169 64396130
Dysarthria 44.38 10.38 144 63289 59262 64376037
Dependence 43.83 10.38 27 63406 2128 64433171
Formication 42.80 10.38 35 63398 4322 64430977
Muscle twitching 42.49 10.38 71 63362 18927 64416372
Incoherent 42.07 10.38 43 63390 7075 64428224
Cardiac failure 41.88 10.38 41 63392 132332 64302967
Exposure via ingestion 41.21 10.38 36 63397 4866 64430433
Cardio-respiratory arrest 40.61 10.38 198 63235 98195 64337104
Snoring 40.60 10.38 35 63398 4647 64430652
Arthropathy 39.99 10.38 36 63397 120931 64314368
Therapeutic product effect decreased 39.75 10.38 33 63400 115318 64319981
Pericarditis 39.30 10.38 7 63426 62509 64372790
Deep vein thrombosis 38.74 10.38 205 63228 104977 64330322
Drug withdrawal syndrome 38.46 10.38 91 63342 31200 64404099
Abdominal pain 37.69 10.38 471 62962 311904 64123395
Mental status changes 37.63 10.38 139 63294 61023 64374276
Pupillary reflex impaired 37.36 10.38 28 63405 3045 64432254
Arthralgia 36.43 10.38 270 63163 441990 63993309
C-reactive protein increased 35.44 10.38 25 63408 94884 64340415
Dehydration 35.38 10.38 347 63086 216416 64218883
Acute kidney injury 35.24 10.38 278 63155 448962 63986337
Therapeutic product effect incomplete 35.17 10.38 30 63403 103452 64331847
Peripheral swelling 35.13 10.38 98 63335 209055 64226244
Product use in unapproved indication 34.13 10.38 77 63356 176541 64258758
Neuroleptic malignant syndrome 33.26 10.38 75 63358 24921 64410378
Hereditary angioedema 31.65 10.38 28 63405 3848 64431451
Glossodynia 31.63 10.38 12 63421 64684 64370615
Renal impairment 31.16 10.38 53 63380 134964 64300335
General physical health deterioration 30.60 10.38 101 63332 204324 64230975
Interstitial lung disease 30.07 10.38 31 63402 97701 64337598
Hepatic enzyme increased 29.99 10.38 51 63382 129892 64305407
Fatigue 29.77 10.38 954 62479 747776 63687523
Dystonia 28.99 10.38 60 63373 18805 64416494
Restlessness 28.42 10.38 95 63338 39690 64395609
Pain 28.25 10.38 728 62705 552783 63882516
Drug screen positive 27.50 10.38 31 63402 5698 64429601
Electrocardiogram QRS complex shortened 26.97 10.38 13 63420 628 64434671
Impaired healing 26.72 10.38 13 63420 60460 64374839
Accidental death 26.68 10.38 25 63408 3700 64431599
Systemic lupus erythematosus 25.76 10.38 23 63410 77589 64357710
Overdose 25.32 10.38 254 63179 159312 64275987
Rash 24.93 10.38 310 63123 458239 63977060
Abdominal discomfort 24.66 10.38 94 63339 182228 64253071
Depression 24.54 10.38 282 63151 183009 64252290
Gallbladder hypofunction 24.51 10.38 11 63422 451 64434848
Cholestasis 24.25 10.38 7 63426 44865 64390434
Drug resistance 24.20 10.38 3 63430 35099 64400200
Pupil fixed 23.74 10.38 22 63411 3210 64432089
Illness anxiety disorder 23.72 10.38 9 63424 239 64435060
Infection 23.31 10.38 98 63335 184782 64250517
Condition aggravated 23.28 10.38 244 63189 372182 64063117
Drug interaction 23.13 10.38 236 63197 361847 64073452
Lower respiratory tract infection 22.89 10.38 36 63397 94578 64340721
Psychotic disorder 22.46 10.38 80 63353 34498 64400801
Product use issue 21.98 10.38 76 63357 151639 64283660
Osteonecrosis of jaw 21.92 10.38 6 63427 39819 64395480
Pulmonary embolism 21.80 10.38 230 63203 146126 64289173
Infusion related reaction 21.47 10.38 86 63347 164381 64270918
Hypersensitivity 21.30 10.38 110 63323 196342 64238957
Hepatocellular injury 21.12 10.38 9 63424 45226 64390073
Alopecia 20.78 10.38 88 63345 165602 64269697
Cholecystectomy 20.67 10.38 32 63401 8000 64427299
Paranoia 20.58 10.38 48 63385 16304 64418995
Wound 20.57 10.38 27 63406 76450 64358849
Mobility decreased 20.45 10.38 33 63400 85807 64349492
Cholesterosis 20.36 10.38 9 63424 356 64434943
Miosis 20.16 10.38 42 63391 13224 64422075
Fall 20.03 10.38 289 63144 416537 64018762
Unresponsive to stimuli 19.78 10.38 100 63333 50293 64385006
Cytomegalovirus infection 19.75 10.38 6 63427 37193 64398106
Suicidal ideation 19.46 10.38 122 63311 66420 64368879
Drug reaction with eosinophilia and systemic symptoms 19.31 10.38 15 63418 54202 64381097
Intentional product misuse 18.98 10.38 129 63304 72166 64363133
Helicobacter infection 18.94 10.38 7 63426 38355 64396944
Melaena 18.84 10.38 15 63418 53533 64381766
Hyperkalaemia 18.79 10.38 45 63388 101084 64334215
Osteoporosis 18.66 10.38 9 63424 42071 64393228
Drug dependence 18.26 10.38 73 63360 33239 64402060
Intentional product use issue 18.07 10.38 42 63391 95322 64339977
Pancytopenia 18.04 10.38 76 63357 143233 64292066
Cholecystitis 17.85 10.38 51 63382 19585 64415714
Tremor 17.62 10.38 223 63210 148007 64287292
Inflammation 17.62 10.38 23 63410 65277 64370022
Uterine perforation 17.58 10.38 25 63408 5795 64429504
Electrocardiogram QT prolonged 17.54 10.38 136 63297 79312 64355987
Jaw clicking 17.48 10.38 4 63429 15 64435284
Reversible cerebral vasoconstriction syndrome 17.32 10.38 16 63417 2326 64432973
Bradycardia 17.27 10.38 59 63374 118160 64317139
Coma blister 17.08 10.38 7 63426 229 64435070
Respiratory rate increased 17.04 10.38 48 63385 18283 64417016
Fear 17.00 10.38 51 63382 20120 64415179
Gallbladder cholesterolosis 16.65 10.38 9 63424 554 64434745
Cough 16.49 10.38 204 63229 301944 64133355
Blood pressure fluctuation 16.47 10.38 16 63417 51855 64383444
Angioedema 16.45 10.38 22 63411 61799 64373500
Obsessive thoughts 16.38 10.38 11 63422 1006 64434293
General symptom 16.05 10.38 15 63418 2213 64433086
Arthritis 15.81 10.38 37 63396 83777 64351522
Stomatitis 15.81 10.38 55 63378 109550 64325749
Neutropenia 15.77 10.38 155 63278 239469 64195830
Hepatitis 15.74 10.38 13 63420 45569 64389730
Psychomotor hyperactivity 15.61 10.38 40 63393 14411 64420888
Finger amputation 15.60 10.38 9 63424 629 64434670
Toxic epidermal necrolysis 14.94 10.38 9 63424 37157 64398142
Anhedonia 14.87 10.38 38 63395 13668 64421631
Impaired gastric emptying 14.72 10.38 29 63404 8775 64426524
Seizure 14.62 10.38 238 63195 166654 64268645
Confusional state 14.31 10.38 347 63086 260797 64174502
Folliculitis 14.01 10.38 6 63427 30071 64405228
Pulmonary fibrosis 13.86 10.38 6 63427 29872 64405427
Biliary colic 13.81 10.38 17 63416 3427 64431872
Pneumocystis jirovecii pneumonia 13.72 10.38 5 63428 27629 64407670
Gas gangrene 13.63 10.38 6 63427 235 64435064
Therapeutic response decreased 13.45 10.38 19 63414 52169 64383130
Red blood cell sedimentation rate increased 13.37 10.38 7 63426 31228 64404071
Chest pain 13.36 10.38 315 63118 235665 64199634
Prolonged rupture of membranes 13.27 10.38 4 63429 51 64435248
Respiratory rate decreased 13.14 10.38 19 63414 4472 64430827
Aggression 13.04 10.38 84 63349 46148 64389151
Arm amputation 13.00 10.38 5 63428 138 64435161
Fear of disease 12.71 10.38 9 63424 896 64434403
Differential white blood cell count abnormal 12.68 10.38 12 63421 1798 64433501
Extrapyramidal disorder 12.50 10.38 45 63388 19507 64415792
Psoriasis 12.47 10.38 33 63400 71670 64363629
Hypophagia 12.47 10.38 74 63359 39513 64395786
Blood potassium decreased 12.39 10.38 75 63358 40324 64394975
Jugular vein thrombosis 12.38 10.38 17 63416 3814 64431485
Hypoglycaemia 12.37 10.38 46 63387 89846 64345453
Heart rate decreased 12.35 10.38 22 63411 55045 64380254
Psychological trauma 12.32 10.38 10 63423 1222 64434077
Blastocystis infection 12.26 10.38 3 63430 16 64435283
Inappropriate schedule of product administration 12.20 10.38 48 63385 92238 64343061
Sopor 12.18 10.38 7 63426 29654 64405645
Lymphopenia 12.14 10.38 5 63428 25652 64409647
Dyspnoea 12.05 10.38 581 62852 718093 63717206
Leukopenia 11.94 10.38 55 63378 101187 64334112
Inadequate analgesia 11.89 10.38 17 63416 3961 64431338
Malaise 11.55 10.38 299 63134 395948 64039351
Loss of personal independence in daily activities 11.38 10.38 35 63398 72419 64362880
Gallbladder enlargement 11.29 10.38 10 63423 1376 64433923
Base excess increased 11.29 10.38 4 63429 87 64435212
Angina pectoris 11.05 10.38 17 63416 45064 64390235
Withdrawal syndrome 10.95 10.38 49 63384 23443 64411856
Postpartum haemorrhage 10.92 10.38 10 63423 1437 64433862
CSF pressure increased 10.85 10.38 5 63428 218 64435081
Cholecystitis acute 10.81 10.38 30 63403 11330 64423969
Upper respiratory tract irritation 10.81 10.38 4 63429 99 64435200
Panic attack 10.76 10.38 45 63388 20908 64414391
Atrial fibrillation 10.70 10.38 112 63321 170977 64264322
Transverse sinus thrombosis 10.69 10.38 7 63426 613 64434686
Drug eruption 10.52 10.38 12 63421 36124 64399175
Urinary hesitation 10.49 10.38 15 63418 3495 64431804
Anticholinergic syndrome 10.43 10.38 13 63420 2656 64432643
Failure to thrive 10.42 10.38 28 63405 10376 64424923

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 46.94 28.12 11 214 11 84442
Pulmonary haemorrhage neonatal 42.65 28.12 10 215 10 84443
Congenital tricuspid valve incompetence 32.45 28.12 10 215 46 84407

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 D018926 Anti-Allergic Agents
MeSH PA D000982 Antipruritics
MeSH PA D003879 Dermatologic Agents
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D018377 Neurotransmitter Agents
CHEBI has role CHEBI:35717 hypnotics
CHEBI has role CHEBI:36333 local anesthetics
CHEBI has role CHEBI:37955 H1 receptor antagonists
CHEBI has role CHEBI:50857 anti-allergic drugs
CHEBI has role CHEBI:50919 antiemetico
CHEBI has role CHEBI:59683 antipruritic drugs
CHEBI has role CHEBI:149553 anticoronaviral drug
CHEBI has role CHEBI:176497 geroprotectors
FDA EPC N0000175746 Phenothiazine

Drug Use (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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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(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
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
D(1A) dopamine receptor GPCR Ki 5.86 DRUG MATRIX
Calmodulin-1 Cytosolic other IC50 4.22 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 7.68 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR IC50 7.10 CHEMBL
5-hydroxytryptamine receptor 1A GPCR IC50 5.59 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

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
CHEMBL1200750 ChEMBL_ID
CHEMBL251904 ChEMBL_ID
CHEMBL643 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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 2 0121-0547 SYRUP 6.25 mg ORAL ANDA 30 sections
Promethazine VC with Codeine Oral Solution HUMAN PRESCRIPTION DRUG LABEL 3 0121-0925 SOLUTION 6.25 mg ORAL ANDA 29 sections
Promethazine VC HUMAN PRESCRIPTION DRUG LABEL 2 0121-0926 SOLUTION 6.25 mg ORAL ANDA 25 sections
Promethazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0121-0927 SOLUTION 6.25 mg ORAL ANDA 25 sections
Promethazine with Codeine HUMAN PRESCRIPTION DRUG LABEL 2 0121-0928 SOLUTION 6.25 mg ORAL ANDA 29 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 0404-9942 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 0641-0928 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 0641-0929 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 0641-0955 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 0641-0956 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 0641-6084 INJECTION 25 mg INTRAMUSCULAR ANDA 26 sections
PHENERGAN HUMAN PRESCRIPTION DRUG LABEL 1 0641-6085 INJECTION 50 mg INTRAMUSCULAR ANDA 26 sections