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
S (Water solubility) 100 mg/mL Bocci G, Oprea TI, Benet LZ

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 6783.21 10.44 2029 65012 23658 63398323
Intentional overdose 5402.75 10.44 2245 64796 71907 63350074
Akathisia 541.15 10.44 240 66801 8906 63413075
Tachycardia 465.60 10.44 598 66443 117558 63304423
Depressed level of consciousness 384.41 10.44 397 66644 61681 63360300
Cholecystitis chronic 310.24 10.44 171 66870 10190 63411791
Drug ineffective 281.14 10.44 420 66621 1044345 62377636
Mydriasis 279.64 10.44 168 66873 11788 63410193
Contraindicated product administered 210.00 10.44 4 67037 217644 63204337
Anxiety 198.18 10.44 591 66450 216950 63205031
Synovitis 167.27 10.44 7 67034 186911 63235070
Glossodynia 149.74 10.44 10 67031 178866 63243115
Hand deformity 149.62 10.44 4 67037 159453 63262528
Drug intolerance 147.21 10.44 71 66970 308590 63113391
Treatment failure 145.79 10.44 19 67022 199024 63222957
Hallucination 142.67 10.44 228 66813 54589 63367392
Somnolence 141.86 10.44 463 66578 178222 63243759
Joint swelling 133.95 10.44 91 66950 327575 63094406
Arthropathy 131.68 10.44 42 66999 234750 63187231
Agitation 120.56 10.44 222 66819 59535 63362446
Off label use 118.88 10.44 344 66697 674118 62747863
Poisoning 117.65 10.44 105 66936 13595 63408386
Systemic lupus erythematosus 114.27 10.44 39 67002 208879 63213102
Pericarditis 111.15 10.44 7 67034 131572 63290409
Rheumatoid arthritis 108.44 10.44 67 66974 253752 63168229
Therapeutic product effect decreased 102.34 10.44 38 67003 193149 63228832
Biliary dyskinesia 101.33 10.44 52 66989 2677 63419304
Emotional distress 98.20 10.44 145 66896 32404 63389577
Gallbladder disorder 96.35 10.44 109 66932 18733 63403248
Abdominal discomfort 95.68 10.44 119 66922 320766 63101215
Vomiting 92.93 10.44 950 66091 558667 62863314
Suicide attempt 92.47 10.44 201 66840 60717 63361264
Wound 90.09 10.44 30 67011 163233 63258748
Sinus tachycardia 89.42 10.44 119 66922 24149 63397832
Product use issue 86.41 10.44 64 66977 220456 63201525
Gallbladder injury 86.27 10.44 38 67003 1385 63420596
Hepatic enzyme increased 85.57 10.44 54 66987 202274 63219707
Alopecia 80.45 10.44 146 66895 337390 63084591
Toxicity to various agents 79.96 10.44 490 66551 246760 63175221
Helicobacter infection 78.16 10.44 5 67036 92780 63329201
Infusion related reaction 77.48 10.44 87 66954 245434 63176547
Cholelithiasis 72.52 10.44 150 66891 43775 63378206
Migraine 71.57 10.44 256 66785 103090 63318891
Rash 69.77 10.44 330 66711 560541 62861440
Drug abuse 68.70 10.44 200 66841 72318 63349663
Respiratory arrest 67.99 10.44 123 66918 32522 63389459
Nasopharyngitis 67.97 10.44 102 66939 254155 63167826
Incoherent 65.19 10.44 47 66994 4483 63417498
Injury 64.63 10.44 197 66844 73050 63348931
Accidental overdose 60.68 10.44 97 66944 23212 63398769
Arthralgia 59.80 10.44 355 66686 569355 62852626
Loss of consciousness 58.82 10.44 264 66777 117857 63304124
Therapeutic product effect incomplete 57.67 10.44 30 67011 125026 63296955
Snoring 56.85 10.44 42 66999 4160 63417821
Peripheral swelling 56.47 10.44 123 66918 265819 63156162
Lethargy 54.52 10.44 156 66885 55851 63366130
Muscle twitching 54.18 10.44 84 66957 19584 63402397
Folliculitis 53.19 10.44 6 67035 70311 63351670
Swelling 53.15 10.44 134 66907 275244 63146737
Hypersensitivity 52.28 10.44 148 66893 292537 63129444
Impaired healing 51.27 10.44 22 67019 102520 63319461
C-reactive protein increased 51.19 10.44 18 67023 94689 63327292
Lower respiratory tract infection 49.76 10.44 40 67001 132267 63289714
Dependence 48.08 10.44 29 67012 2048 63419933
Formication 47.35 10.44 38 67003 4253 63417728
Nausea 47.18 10.44 1207 65834 853264 62568717
Discomfort 46.81 10.44 65 66976 167309 63254672
Serotonin syndrome 46.23 10.44 97 66944 28585 63393396
Deep vein thrombosis 46.08 10.44 193 66848 83607 63338374
Pulmonary haemorrhage neonatal 45.76 10.44 10 67031 26 63421955
Opisthotonus 44.39 10.44 16 67025 340 63421641
Suicidal ideation 44.37 10.44 156 66885 62265 63359716
General physical health deterioration 43.69 10.44 92 66949 201310 63220671
Mobility decreased 42.67 10.44 39 67002 121120 63300861
Cardiac arrest 42.48 10.44 202 66839 92343 63329638
Hereditary angioedema 40.80 10.44 45 66996 7517 63414464
Abdominal pain 39.71 10.44 479 66562 292977 63129004
Maternal exposure during pregnancy 39.48 10.44 111 66930 219951 63202030
Accidental death 39.18 10.44 25 67016 1951 63420030
Drug abuser 39.06 10.44 29 67012 2894 63419087
Pupillary reflex impaired 38.37 10.44 25 67016 2022 63419959
Drug hypersensitivity 38.14 10.44 498 66543 310189 63111792
Completed suicide 37.54 10.44 273 66768 145400 63276581
Mental status changes 37.28 10.44 109 66932 39490 63382491
Dysarthria 35.93 10.44 113 66928 42598 63379383
Congenital tricuspid valve incompetence 35.42 10.44 10 67031 92 63421889
Depression 33.58 10.44 336 66705 196156 63225825
Electrocardiogram QRS complex shortened 33.28 10.44 14 67027 455 63421526
Neonatal hypotension 32.36 10.44 10 67031 129 63421852
Liver injury 31.86 10.44 12 67029 60508 63361473
Psoriatic arthropathy 31.58 10.44 30 67011 91490 63330491
Hip arthroplasty 31.57 10.44 6 67035 47640 63374341
Drug screen positive 31.52 10.44 28 67013 3601 63418380
Seizure 31.03 10.44 243 66798 132391 63289590
Cholecystitis 30.83 10.44 57 66984 15320 63406661
Musculoskeletal stiffness 30.31 10.44 97 66944 184521 63237460
Product use in unapproved indication 30.17 10.44 93 66948 178987 63242994
Fear 29.81 10.44 57 66984 15709 63406272
Poor feeding infant 29.49 10.44 12 67029 358 63421623
Dehydration 29.40 10.44 296 66745 173058 63248923
Blister 29.24 10.44 58 66983 129756 63292225
Cardiac failure 28.73 10.44 31 67010 89111 63332870
Gallbladder hypofunction 27.37 10.44 13 67028 565 63421416
Intentional product use issue 27.23 10.44 59 66982 127833 63294148
Newborn persistent pulmonary hypertension 27.21 10.44 10 67031 225 63421756
Paranoia 26.90 10.44 46 66995 11633 63410348
Pulmonary embolism 26.87 10.44 213 66828 116471 63305510
Ill-defined disorder 26.83 10.44 28 67013 81727 63340254
Stomatitis 26.35 10.44 68 66973 138657 63283324
Gallbladder cholesterolosis 26.06 10.44 14 67027 792 63421189
Biliary colic 25.79 10.44 25 67016 3592 63418389
Impaired gastric emptying 25.53 10.44 42 66999 10290 63411691
Drug reaction with eosinophilia and systemic symptoms 25.31 10.44 3 67038 33833 63388148
Respiratory disorder neonatal 25.30 10.44 16 67025 1229 63420752
Gastrointestinal disorder 25.18 10.44 64 66977 131175 63290806
Neonatal respiratory failure 25.07 10.44 10 67031 283 63421698
Anhedonia 24.98 10.44 43 66998 10931 63411050
Restlessness 24.84 10.44 78 66963 29375 63392606
Exposure via ingestion 24.39 10.44 22 67019 2887 63419094
Red blood cell sedimentation rate increased 24.38 10.44 8 67033 43974 63378007
Infection 24.37 10.44 142 66899 229031 63192950
Tremor 23.98 10.44 229 66812 132010 63289971
Illness anxiety disorder 23.97 10.44 8 67033 134 63421847
Tardive dyskinesia 22.98 10.44 36 67005 8466 63413515
Atrial septal defect 22.51 10.44 32 67009 6906 63415075
Pulmonary fibrosis 22.50 10.44 7 67034 39802 63382179
Cardio-respiratory arrest 22.02 10.44 123 66918 59836 63362145
Therapeutic response decreased 21.42 10.44 20 67021 61505 63360476
Electrocardiogram QT prolonged 21.13 10.44 121 66920 59409 63362572
Drug withdrawal syndrome 21.10 10.44 70 66971 27124 63394857
Miosis 21.09 10.44 32 67009 7321 63414660
Cholesterosis 20.84 10.44 10 67031 445 63421536
Illness 20.31 10.44 104 66937 48955 63373026
Hyperreflexia 20.19 10.44 28 67013 5906 63416075
Arthritis 19.66 10.44 60 66981 115861 63306120
Condition aggravated 19.51 10.44 303 66738 401914 63020067
Mental disorder 19.48 10.44 66 66975 25853 63396128
Irritable bowel syndrome 19.27 10.44 36 67005 82376 63339605
Coma blister 19.24 10.44 7 67034 153 63421828
Unresponsive to stimuli 18.67 10.44 78 66963 33738 63388243
Knee arthroplasty 18.43 10.44 18 67023 54188 63367793
Differential white blood cell count abnormal 18.26 10.44 11 67030 775 63421206
Blood pressure fluctuation 17.41 10.44 14 67027 46303 63375678
Cholecystectomy 17.08 10.44 36 67005 10641 63411340
Renal impairment 17.01 10.44 43 66998 88312 63333669
Therapy non-responder 17.01 10.44 34 67007 75867 63346114
Cholestasis 16.95 10.44 5 67036 29429 63392552
Ventricular septal defect 16.95 10.44 22 67019 4356 63417625
Aggression 16.93 10.44 59 66982 23439 63398542
Type 2 diabetes mellitus 16.67 10.44 26 67015 63842 63358139
Device expulsion 16.66 10.44 8 67033 34914 63387067
Blood cholesterol increased 16.42 10.44 48 66993 93984 63327997
Fatigue 16.39 10.44 1117 65924 886911 62535070
Cough 16.12 10.44 215 66826 292528 63129453
Intestinal obstruction 16.07 10.44 70 66971 30829 63391152
Loss of personal independence in daily activities 16.04 10.44 51 66990 97239 63324742
Pupil fixed 15.80 10.44 14 67027 1795 63420186
Cyanosis neonatal 15.79 10.44 8 67033 401 63421580
Jaw clicking 15.52 10.44 4 67037 25 63421956
Attention-seeking behaviour 15.49 10.44 5 67036 75 63421906
Fear of disease 15.12 10.44 12 67029 1322 63420659
pH body fluid increased 15.03 10.44 3 67038 4 63421977
Overdose 14.73 10.44 186 66855 114892 63307089
Vasoplegia syndrome 14.54 10.44 13 67028 1686 63420295
Sitting disability 14.47 10.44 7 67034 317 63421664
Melaena 14.42 10.44 7 67034 30358 63391623
Inflammation 14.37 10.44 42 66999 82231 63339750
Neutropenia 14.35 10.44 117 66924 174888 63247093
Long QT syndrome congenital 14.16 10.44 5 67036 100 63421881
Drug-induced liver injury 14.09 10.44 13 67028 40209 63381772
Base excess increased 14.05 10.44 4 67037 38 63421943
Respiratory rate decreased 14.05 10.44 18 67023 3517 63418464
Psychotic disorder 13.95 10.44 59 66982 25653 63396328
Pancreatitis chronic 13.78 10.44 15 67026 2469 63419512
Adverse event 13.70 10.44 32 67009 67527 63354454
Finger amputation 13.44 10.44 8 67033 551 63421430
Musculoskeletal pain 13.44 10.44 51 66990 92226 63329755
Wrong patient received product 13.43 10.44 14 67027 2193 63419788
Pre-existing condition improved 13.42 10.44 28 67013 8216 63413765
Acute lung injury 13.41 10.44 12 67029 1559 63420422
Nephrolithiasis 13.40 10.44 83 66958 41901 63380080
Blastocystis infection 13.29 10.44 4 67037 47 63421934
Respiratory rate increased 13.26 10.44 38 67003 13610 63408371
Small intestinal obstruction 13.17 10.44 46 66995 18291 63403690
Cytomegalovirus infection 13.13 10.44 3 67038 20949 63401032
Suicidal behaviour 13.04 10.44 15 67026 2624 63419357
Drug resistance 13.02 10.44 4 67037 22929 63399052
Uterine perforation 12.95 10.44 25 67016 6938 63415043
Prolonged rupture of membranes 12.92 10.44 4 67037 52 63421929
Patent ductus arteriosus 12.91 10.44 19 67022 4231 63417750
Postpartum haemorrhage 12.84 10.44 13 67028 1968 63420013
Ventricular extrasystoles 12.80 10.44 34 67007 11653 63410328
Blood potassium decreased 12.74 10.44 82 66959 41944 63380037
Insurance issue 12.66 10.44 23 67018 6098 63415883
Hepatitis 12.64 10.44 14 67027 39774 63382207
Jugular vein thrombosis 12.59 10.44 16 67025 3102 63418879
Neuroleptic malignant syndrome 12.13 10.44 34 67007 12022 63409959
Obsessive-compulsive disorder 12.11 10.44 18 67023 4042 63417939
Constipation 12.07 10.44 317 66724 224626 63197355
Hypophagia 12.06 10.44 65 66976 31194 63390787
Hyperkinetic heart syndrome 12.04 10.44 3 67038 16 63421965
Neonatal tachycardia 12.04 10.44 3 67038 16 63421965
Panic attack 11.93 10.44 51 66990 22280 63399701
Activated partial thromboplastin time prolonged 11.92 10.44 24 67017 6869 63415112
Osteoporosis 11.75 10.44 27 67014 57311 63364670
Retching 11.63 10.44 38 67003 14607 63407374
Malnutrition 11.53 10.44 39 67002 15259 63406722
Arm amputation 11.47 10.44 3 67038 20 63421961
Weight increased 11.46 10.44 200 66841 260592 63161389
Scar 11.16 10.44 36 67005 13746 63408235
Cholecystitis acute 11.12 10.44 26 67015 8234 63413747
Slow response to stimuli 11.09 10.44 9 67032 1023 63420958
Fallot's tetralogy 11.01 10.44 4 67037 87 63421894
Adverse drug reaction 11.01 10.44 45 66996 79669 63342312
Infusion site pain 11.00 10.44 41 67000 16828 63405153
Lentigo 11.00 10.44 6 67035 350 63421631
Withdrawal syndrome 10.94 10.44 46 66995 19951 63402030
Appetite disorder 10.92 10.44 24 67017 7297 63414684
Transverse sinus thrombosis 10.91 10.44 7 67034 551 63421430
Visceral oedema 10.89 10.44 3 67038 25 63421956
Prescribed overdose 10.86 10.44 12 67029 34141 63387840
Catatonia 10.79 10.44 18 67023 4459 63417522
Patient uncooperative 10.76 10.44 5 67036 207 63421774
Pickwickian syndrome 10.74 10.44 6 67035 367 63421614
Radial pulse abnormal 10.68 10.44 3 67038 27 63421954
Hepatocellular injury 10.64 10.44 8 67033 27373 63394608
Intestinal ischaemia 10.60 10.44 24 67017 7444 63414537

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 2129.99 12.14 662 24800 13109 34918360
Intentional overdose 1659.05 12.14 749 24713 42925 34888544
Akathisia 163.92 12.14 91 25371 8018 34923451
Depressed level of consciousness 116.99 12.14 150 25312 42691 34888778
Respiratory arrest 90.77 12.14 107 25355 27936 34903533
Tachycardia 89.04 12.14 193 25269 84579 34846890
Sinus tachycardia 71.24 12.14 75 25387 17285 34914184
Drug ineffective 67.14 12.14 146 25316 456605 34474864
Off label use 64.22 12.14 131 25331 419393 34512076
Somnolence 62.15 12.14 200 25262 110916 34820553
Mydriasis 56.80 12.14 45 25417 7192 34924277
Dystonia 53.93 12.14 52 25410 10793 34920676
Vomiting 51.39 12.14 332 25130 247289 34684180
Poisoning 50.48 12.14 53 25409 12173 34919296
Agitation 48.46 12.14 120 25342 57279 34874190
Dysarthria 39.71 12.14 82 25380 34700 34896769
Hallucination 38.64 12.14 103 25359 51395 34880074
Loss of consciousness 37.62 12.14 139 25323 82528 34848941
Exposure during pregnancy 37.36 12.14 39 25423 8895 34922574
Neuroleptic malignant syndrome 35.73 12.14 54 25408 17880 34913589
Anxiety 31.76 12.14 150 25312 99278 34832191
Consciousness fluctuating 31.56 12.14 16 25446 1171 34930298
Interstitial lung disease 31.32 12.14 5 25457 65277 34866192
Cardio-respiratory arrest 30.41 12.14 99 25363 55174 34876295
Autoscopy 29.97 12.14 10 25452 247 34931222
Dehydration 29.20 12.14 178 25284 129791 34801678
Toxicity to various agents 27.54 12.14 244 25218 200118 34731351
Lethargy 26.65 12.14 78 25384 41044 34890425
Cardiac arrest 25.04 12.14 137 25325 96022 34835447
Failure to thrive 24.85 12.14 31 25431 8570 34922899
General symptom 23.75 12.14 12 25450 872 34930597
Dextrocardia 23.66 12.14 7 25455 115 34931354
Foetal alcohol syndrome 22.46 12.14 7 25455 138 34931331
Condition aggravated 22.28 12.14 69 25393 192127 34739342
Overdose 21.25 12.14 126 25336 90933 34840536
Opisthotonus 20.82 12.14 9 25453 458 34931011
Drug withdrawal syndrome 20.59 12.14 45 25417 19789 34911680
Confusional state 20.53 12.14 177 25285 143983 34787486
Unresponsive to stimuli 20.52 12.14 55 25407 27514 34903955
Atrial septal defect 20.33 12.14 26 25436 7366 34924103
Nasopharyngitis 20.23 12.14 13 25449 69955 34861514
Psychotic disorder 19.44 12.14 50 25412 24402 34907067
Respiratory depression 19.36 12.14 39 25423 16206 34915263
Completed suicide 18.69 12.14 129 25333 98039 34833430
Acute kidney injury 18.59 12.14 138 25324 304850 34626619
Drug hypersensitivity 18.51 12.14 111 25351 80418 34851051
Patent ductus arteriosus 18.43 12.14 17 25445 3337 34928132
Cardiomegaly 18.33 12.14 37 25425 15401 34916068
Nausea 18.26 12.14 348 25114 339560 34591909
Therapeutic product effect incomplete 18.21 12.14 7 25455 50534 34880935
Hepatic ischaemia 18.18 12.14 8 25454 425 34931044
Exposure via ingestion 18.06 12.14 14 25448 2167 34929302
Product use in unapproved indication 17.60 12.14 37 25425 117462 34814007
Accidental overdose 16.86 12.14 42 25420 20098 34911371
Fallot's tetralogy 16.73 12.14 6 25456 185 34931284
Obsessive thoughts 16.71 12.14 9 25453 746 34930723
Extrapyramidal disorder 16.66 12.14 32 25430 12848 34918621
Tracheobronchitis 16.55 12.14 10 25452 1031 34930438
Psychomotor hyperactivity 16.43 12.14 27 25435 9595 34921874
Upper respiratory tract irritation 15.25 12.14 4 25458 41 34931428
Skin swelling 14.08 12.14 10 25452 1355 34930114
Foetal exposure during pregnancy 14.04 12.14 60 25402 38041 34893428
Congenital aortic valve stenosis 14.00 12.14 5 25457 152 34931317
Sedation 13.75 12.14 40 25422 20966 34910503
Pupil fixed 13.71 12.14 11 25451 1790 34929679
Intentional product use issue 13.69 12.14 14 25448 59802 34871667
Fatigue 13.44 12.14 359 25103 370294 34561175
Restlessness 13.43 12.14 45 25417 25437 34906032
Multiple organ dysfunction syndrome 13.33 12.14 22 25440 76544 34854925
Aggression 13.32 12.14 60 25402 38904 34892565
Gallbladder enlargement 13.22 12.14 9 25453 1139 34930330
Mucosal haemorrhage 12.53 12.14 10 25452 1615 34929854
Ventricular septal defect 12.49 12.14 15 25447 3986 34927483
Angioedema 12.16 12.14 6 25456 37368 34894101

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 5502.25 10.31 1743 67326 30676 79644643
Intentional overdose 4203.96 10.31 1975 67094 103985 79571334
Akathisia 575.58 10.31 264 68805 12995 79662324
Tachycardia 377.00 10.31 604 68465 177164 79498155
Depressed level of consciousness 343.55 10.31 421 68648 96231 79579088
Cholecystitis chronic 287.91 10.31 150 68919 9756 79665563
Mydriasis 226.51 10.31 158 68911 17485 79657834
Drug ineffective 206.87 10.31 390 68679 1080523 78594796
Anxiety 174.56 10.31 542 68527 247970 79427349
Poisoning 174.35 10.31 157 68912 25115 79650204
Respiratory arrest 173.32 10.31 231 68838 57319 79618000
Off label use 172.74 10.31 328 68741 906887 78768432
Hallucination 136.55 10.31 257 68812 85488 79589831
Somnolence 129.58 10.31 478 68591 238503 79436816
Vomiting 123.48 10.31 991 68078 664837 79010482
Synovitis 116.35 10.31 3 69066 150731 79524588
Agitation 114.23 10.31 261 68808 99454 79575865
Toxicity to various agents 109.35 10.31 681 68388 420859 79254460
Biliary dyskinesia 108.30 10.31 50 69019 2495 79672824
Sinus tachycardia 107.82 10.31 146 68923 36762 79638557
Gallbladder injury 95.60 10.31 37 69032 1184 79674135
Emotional distress 94.54 10.31 143 68926 39826 79635493
Gallbladder disorder 93.69 10.31 99 68970 19241 79656078
Suicide attempt 90.50 10.31 213 68856 82719 79592600
Drug intolerance 83.44 10.31 64 69005 264055 79411264
Contraindicated product administered 80.09 10.31 19 69050 157519 79517800
Hand deformity 76.86 10.31 3 69066 103916 79571403
Cardiac arrest 76.84 10.31 324 68745 171772 79503547
Joint swelling 74.59 10.31 84 68985 288562 79386757
Treatment failure 73.21 10.31 28 69041 170458 79504861
Drug abuse 73.18 10.31 307 68762 162384 79512935
Injury 71.83 10.31 187 68882 77309 79598010
Rheumatoid arthritis 70.43 10.31 47 69022 208423 79466896
Completed suicide 69.29 10.31 406 68663 245361 79429958
Nasopharyngitis 67.67 10.31 72 68997 253809 79421510
Pericarditis 65.43 10.31 7 69062 104229 79571090
Accidental overdose 63.43 10.31 119 68950 39462 79635857
Opisthotonus 61.36 10.31 23 69046 673 79674646
Drug hypersensitivity 61.30 10.31 456 68613 298460 79376859
Arthropathy 61.09 10.31 39 69030 177072 79498247
Lethargy 59.45 10.31 180 68889 81112 79594207
Loss of consciousness 56.40 10.31 291 68778 167652 79507667
Serotonin syndrome 56.19 10.31 122 68947 44905 79630414
Nausea 56.13 10.31 1150 67919 956046 78719273
Therapeutic product effect decreased 53.93 10.31 38 69031 163825 79511494
Cholelithiasis 52.87 10.31 131 68938 52533 79622786
Glossodynia 51.46 10.31 13 69056 103324 79571995
Drug abuser 50.89 10.31 42 69027 5971 79669348
Cardio-respiratory arrest 50.52 10.31 207 68862 108303 79567016
Dysarthria 48.76 10.31 149 68920 67473 79607846
Dystonia 47.01 10.31 74 68995 21325 79653994
Arthralgia 45.65 10.31 299 68770 571504 79103815
Systemic lupus erythematosus 45.57 10.31 24 69045 121125 79554194
Hepatic enzyme increased 45.15 10.31 55 69014 182555 79492764
C-reactive protein increased 45.05 10.31 28 69041 128999 79546320
Dependence 44.09 10.31 27 69042 2395 79672924
Peripheral swelling 43.92 10.31 106 68963 269511 79405808
Incoherent 43.86 10.31 43 69026 7649 79667670
Therapeutic product effect incomplete 43.84 10.31 35 69034 141610 79533709
Exposure via ingestion 43.50 10.31 36 69033 5138 79670181
Migraine 43.20 10.31 170 68899 87323 79587996
Product use in unapproved indication 42.73 10.31 96 68973 250263 79425056
Formication 42.33 10.31 35 69034 4988 79670331
Drug withdrawal syndrome 42.10 10.31 93 68976 34625 79640694
Dehydration 41.79 10.31 362 68707 247825 79427494
Mental status changes 41.42 10.31 140 68929 66819 79608500
Snoring 39.21 10.31 35 69034 5531 79669788
Muscle twitching 39.11 10.31 74 68995 24690 79650629
Intentional product use issue 38.46 10.31 45 69024 152067 79523252
Pupillary reflex impaired 38.36 10.31 28 69041 3325 79671994
Helicobacter infection 38.31 10.31 7 69062 69697 79605622
Impaired healing 38.28 10.31 14 69055 87641 79587678
Neuroleptic malignant syndrome 38.25 10.31 78 68991 27481 79647838
Deep vein thrombosis 38.16 10.31 206 68863 120713 79554606
Abdominal discomfort 36.69 10.31 104 68965 250623 79424696
General physical health deterioration 36.12 10.31 120 68949 275118 79400201
Cardiac failure 33.85 10.31 51 69018 154791 79520528
Acute kidney injury 32.72 10.31 290 68779 519114 79156205
Product use issue 32.21 10.31 85 68984 209737 79465582
Mobility decreased 32.13 10.31 35 69034 122140 79553179
Wound 32.00 10.31 32 69037 116147 79559172
Overdose 31.68 10.31 270 68799 183936 79491383
Unresponsive to stimuli 31.35 10.31 113 68956 55675 79619644
Drug screen positive 31.09 10.31 32 69037 6031 79669288
Abdominal pain 30.78 10.31 491 68578 389078 79286241
Hereditary angioedema 30.74 10.31 30 69039 5305 79670014
Condition aggravated 30.60 10.31 282 68787 500842 79174477
Alopecia 30.26 10.31 101 68968 231254 79444065
Interstitial lung disease 29.90 10.31 32 69037 112568 79562751
Restlessness 29.45 10.31 98 68971 46394 79628925
Hypersensitivity 29.39 10.31 122 68947 262117 79413202
Rash 29.36 10.31 340 68729 578018 79097301
Illness anxiety disorder 28.12 10.31 10 69059 251 79675068
Folliculitis 27.51 10.31 7 69062 55373 79619946
Depression 27.50 10.31 298 68771 216492 79458827
Electrocardiogram QRS complex shortened 26.94 10.31 13 69056 717 79674602
Lower respiratory tract infection 26.88 10.31 44 69025 129176 79546143
Accidental death 26.37 10.31 25 69044 4266 79671053
Drug resistance 26.07 10.31 3 69066 42210 79633109
Fatigue 26.00 10.31 1017 68052 928710 78746609
Inflammation 25.61 10.31 26 69043 93727 79581592
Infusion related reaction 25.24 10.31 108 68961 230129 79445190
Cholestasis 25.10 10.31 7 69062 52102 79623217
Suicidal ideation 24.72 10.31 131 68938 76209 79599110
Pupil fixed 24.28 10.31 22 69047 3544 79671775
Gallbladder hypofunction 24.07 10.31 11 69058 536 79674783
Seizure 23.68 10.31 259 68810 188575 79486744
Stomatitis 23.64 10.31 58 69011 146699 79528620
Tremor 23.54 10.31 238 68831 169845 79505474
Cholecystectomy 22.66 10.31 34 69035 9398 79665921
Tardive dyskinesia 22.45 10.31 36 69033 10535 79664784
Psychotic disorder 21.70 10.31 82 68987 41320 79633999
Impaired gastric emptying 21.64 10.31 35 69034 10318 79665001
Fear 21.34 10.31 54 69015 21932 79653387
Paranoia 21.28 10.31 50 69019 19382 79655937
Cholesterosis 21.20 10.31 9 69060 367 79674952
Pulmonary fibrosis 21.11 10.31 6 69063 44106 79631213
Drug reaction with eosinophilia and systemic symptoms 20.99 10.31 15 69054 64229 79611090
Infection 20.99 10.31 123 68946 241589 79433730
Cholecystitis 20.98 10.31 54 69015 22158 79653161
Pulmonary embolism 20.86 10.31 234 68835 171420 79503899
Osteonecrosis of jaw 20.46 10.31 6 69063 43220 79632099
Arthritis 20.45 10.31 43 69026 114837 79560482
Pain 20.37 10.31 773 68296 703029 78972290
Loss of personal independence in daily activities 20.35 10.31 36 69033 102544 79572775
Electrocardiogram QT prolonged 20.28 10.31 141 68928 90245 79585074
Blood pressure fluctuation 20.26 10.31 17 69052 67128 79608191
Renal impairment 19.20 10.31 71 68998 157712 79517607
Red blood cell sedimentation rate increased 18.97 10.31 8 69061 45934 79629385
Miosis 18.81 10.31 42 69027 15747 79659572
Psoriatic arthropathy 18.73 10.31 24 69045 77975 79597344
Pancytopenia 18.62 10.31 77 68992 165668 79509651
Hyperkalaemia 18.59 10.31 45 69024 114353 79560966
Hepatocellular injury 18.53 10.31 9 69060 47584 79627735
Uterine perforation 18.50 10.31 25 69044 6278 79669041
Hepatitis 18.22 10.31 13 69056 55714 79619605
Psychomotor hyperactivity 18.07 10.31 43 69026 16806 79658513
Coma blister 17.80 10.31 7 69062 234 79675085
Melaena 17.66 10.31 16 69053 60874 79614445
Aggression 17.57 10.31 89 68980 50869 79624450
Bradycardia 17.15 10.31 60 69009 135497 79539822
Anhedonia 17.05 10.31 39 69030 14859 79660460
Respiratory rate increased 16.90 10.31 49 69020 21551 79653768
Musculoskeletal stiffness 16.87 10.31 86 68983 174922 79500397
Drug dependence 16.82 10.31 75 68994 40694 79634625
Cytomegalovirus infection 16.70 10.31 8 69061 42636 79632683
Angioedema 16.65 10.31 25 69044 76010 79599309
Jaw clicking 16.59 10.31 4 69065 23 79675296
Obsessive thoughts 16.58 10.31 11 69058 1121 79674198
Gallbladder cholesterolosis 16.56 10.31 9 69060 637 79674682
Respiratory depression 16.41 10.31 57 69012 27573 79647746
Extrapyramidal disorder 16.37 10.31 50 69019 22629 79652690
Weight increased 16.08 10.31 158 68911 277228 79398091
General symptom 16.03 10.31 15 69054 2519 79672800
Finger amputation 15.96 10.31 9 69060 685 79674634
Inappropriate schedule of product administration 15.69 10.31 61 69008 133567 79541752
Therapeutic response decreased 15.61 10.31 21 69048 66832 79608487
Cough 15.48 10.31 224 68845 366565 79308754
Reversible cerebral vasoconstriction syndrome 15.43 10.31 16 69053 3041 79672278
Chest pain 15.37 10.31 336 68733 281968 79393351
Biliary colic 15.27 10.31 18 69051 3944 79671375
Hip arthroplasty 15.13 10.31 6 69063 35750 79639569
Infusion site pain 15.01 10.31 36 69033 14140 79661179
Heart rate decreased 14.56 10.31 24 69045 70292 79605027
Pulmonary congestion 14.47 10.31 54 69015 27046 79648273
Discomfort 14.33 10.31 58 69011 125559 79549760
Toxic epidermal necrolysis 13.81 10.31 11 69058 44570 79630749
Prolonged rupture of membranes 13.77 10.31 4 69065 51 79675268
Blood pressure systolic increased 13.75 10.31 23 69046 66963 79608356
Fall 13.62 10.31 320 68749 487309 79188010
Gas gangrene 13.51 10.31 6 69063 273 79675046
Arm amputation 13.45 10.31 5 69064 143 79675176
Jugular vein thrombosis 13.32 10.31 18 69051 4520 79670799
Ill-defined disorder 13.17 10.31 23 69046 65852 79609467
Long QT syndrome congenital 13.16 10.31 5 69064 152 79675167
Lymphopenia 13.14 10.31 5 69064 30552 79644767
Intentional product misuse 13.08 10.31 133 68936 95032 79580287
Pneumocystis jirovecii pneumonia 12.88 10.31 6 69063 32502 79642817
Swelling 12.74 10.31 123 68946 216588 79458731
Neutropenia 12.74 10.31 174 68895 287536 79387783
Respiratory rate decreased 12.74 10.31 19 69050 5224 79670095
Differential white blood cell count abnormal 12.57 10.31 12 69057 2065 79673254
Blood potassium decreased 12.54 10.31 76 68993 46436 79628883
Musculoskeletal pain 12.49 10.31 46 69023 102308 79573011
Mental disorder 12.47 10.31 57 69012 31245 79644074
Failure to thrive 12.45 10.31 30 69039 11814 79663505
Psychological trauma 12.27 10.31 10 69059 1396 79673923
Drug eruption 12.21 10.31 12 69057 43923 79631396
Hypophagia 12.14 10.31 74 68995 45293 79630026
Drug interaction 12.00 10.31 271 68798 414912 79260407
Hyperreflexia 11.95 10.31 24 69045 8361 79666958
Mental impairment 11.94 10.31 40 69029 18996 79656323
Prostate cancer 11.91 10.31 7 69062 33261 79642058
Panic attack 11.90 10.31 47 69022 24169 79651150
Sopor 11.74 10.31 7 69062 33003 79642316
Wrong patient received product 11.60 10.31 17 69052 4601 79670718
Inadequate analgesia 11.57 10.31 17 69052 4612 79670707
Muscle spasms 11.51 10.31 214 68855 174516 79500803
Compulsions 11.35 10.31 6 69063 402 79674917
Irritable bowel syndrome 11.32 10.31 23 69046 62218 79613101
Malnutrition 11.32 10.31 44 69025 22458 79652861
Suicidal behaviour 11.28 10.31 14 69055 3233 79672086
Postpartum haemorrhage 11.18 10.31 10 69059 1585 79673734
Confusional state 11.09 10.31 357 68712 317640 79357679
Transverse sinus thrombosis 11.06 10.31 7 69062 658 79674661
Cholecystitis acute 10.99 10.31 31 69038 13420 79661899
Fear of disease 10.88 10.31 9 69060 1283 79674036
Base excess increased 10.84 10.31 4 69065 112 79675207
Osteoarthritis 10.81 10.31 39 69030 87270 79588049
Withdrawal syndrome 10.78 10.31 49 69020 26805 79648514
CSF pressure increased 10.75 10.31 5 69064 254 79675065
Osteoporosis 10.72 10.31 19 69050 54093 79621226
Knee arthroplasty 10.71 10.31 13 69056 43235 79632084
Illness 10.69 10.31 73 68996 46438 79628881
Gallbladder enlargement 10.67 10.31 10 69059 1683 79673636
Psoriasis 10.45 10.31 41 69028 89546 79585773
Angina pectoris 10.40 10.31 18 69051 51714 79623605
Schizoaffective disorder 10.39 10.31 11 69058 2141 79673178
Haemophagocytic lymphohistiocytosis 10.39 10.31 3 69066 21834 79653485

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 47.43 26.23 11 217 11 89553
Pulmonary haemorrhage neonatal 43.10 26.23 10 218 10 89554
Congenital tricuspid valve incompetence 32.89 26.23 10 218 46 89518

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 | 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




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
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
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 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 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 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 0404-9940 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 0404-9941 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 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 0641-0948 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 0641-0949 INJECTION 50 mg INTRAMUSCULAR ANDA 25 sections