promethazine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	2286	60-87-7

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
25	mg	O
25	mg	P
25	mg	R

ADMET properties:

Property	Value	Reference
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

Approvals:

Date	Agency	Company	Orphan
March 29, 1951	FDA	DELCOR ASSET CORP

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Histamine H1 receptor	GPCR	P35367	HRH1_HUMAN	ANTAGONIST	Ki	9.62	WOMBAT-PK	CHEMBL
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN		Ki	6.61	WOMBAT-PK
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN		Ki	6.59	DRUG MATRIX
Sigma non-opioid intracellular receptor 1	Membrane receptor	Q99720	SGMR1_HUMAN		Ki	6.92	DRUG MATRIX
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN		IC50	5.12	CHEMBL
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Ki	5.38	DRUG MATRIX
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN		Ki	5.83	DRUG MATRIX
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN		Ki	6.77	WOMBAT-PK
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		Ki	7.37	DRUG MATRIX
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN		Ki	8.19	DRUG MATRIX
5-hydroxytryptamine receptor 6	GPCR	P50406	5HT6R_HUMAN		Ki	5.95	DRUG MATRIX
Alpha-1A adrenergic receptor	GPCR	P35348	ADA1A_HUMAN				WOMBAT-PK
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN		Ki	7.62	DRUG MATRIX
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	6.72	DRUG MATRIX
Histamine H2 receptor	GPCR	P25021	HRH2_HUMAN		Ki	5.94	DRUG MATRIX
Histamine H4 receptor	GPCR	Q9H3N8	HRH4_HUMAN		Ki	6.82	WOMBAT-PK
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		Ki	8.48	DRUG MATRIX
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN		Ki	7.92	DRUG MATRIX
Muscarinic acetylcholine receptor M3	GPCR	P20309	ACM3_HUMAN		Ki	8.38	DRUG MATRIX
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN		Ki	8.98	DRUG MATRIX
Muscarinic acetylcholine receptor M5	GPCR	P08912	ACM5_HUMAN		Ki	8.48	DRUG MATRIX
Aldehyde oxidase	Enzyme	Q06278	AOXA_HUMAN		IC50	6.29	WOMBAT-PK
Alpha-2C adrenergic receptor	GPCR	P18825	ADA2C_HUMAN		Ki	6.45	DRUG MATRIX
Cytochrome P450 2D6	Enzyme	P10635	CP2D6_HUMAN		Ki	5.42	WOMBAT-PK
Alpha-1D adrenergic receptor	GPCR	P25100	ADA1D_HUMAN		Ki	7.50	DRUG MATRIX
Cholinesterase	Enzyme	P06276	CHLE_HUMAN		Ki	7.10	WOMBAT-PK
Major prion protein	Surface antigen	P04156	PRIO_HUMAN		EC50	5.10	CHEMBL
Solute carrier family 22 member 1	Transporter	O15245	S22A1_HUMAN		IC50	4.45	CHEMBL
Sodium channel alpha subunits; brain (Types I, II, III)	Ion channel	P35498 Q99250 Q9NY46	SCN1A_HUMAN SCN2A_HUMAN SCN3A_HUMAN		IC50	5.16	CHEMBL
FAD-linked sulfhydryl oxidase ALR	Enzyme	P55789	ALR_HUMAN		AC50	6.44	CHEMBL
D(1A) dopamine receptor	GPCR	P21728	DRD1_HUMAN		Ki	5.86	DRUG MATRIX
Calmodulin-1	Cytosolic other	P0DP23	CALM1_HUMAN		IC50	4.22	CHEMBL
Alpha-1B adrenergic receptor	GPCR		ADA1B_RAT		Ki	7.68	DRUG MATRIX
Alpha-1A adrenergic receptor	GPCR		ADA1A_RAT		IC50	7.10	CHEMBL
5-hydroxytryptamine receptor 1A	GPCR		5HT1A_RAT		IC50	5.59	CHEMBL
Pleiotropic ABC efflux transporter of multiple drugs	Transporter		PDR5_YEAST		IC50	4.75	CHEMBL
Chloroquine resistance transporter	Transporter		CRT_PLAFA		IC50	4.07	CHEMBL
Calmodulin	Cytosolic other		CALM_BOVIN		Kd	4.30	CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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