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

Stem definition	Drug id	CAS RN
	616	132-22-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: chlorphenamine chloropheniramine chlorophenylpyridamine chloroprophenpyridamine chlorpheniramine chlorprophenpyridamine chlorpheniramine maleate chlorpheniramine tannate chlorpheniramine polistirex	A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE. Molecular weight: 274.79 Formula: C16H19ClN2 CLOGP: 3.15 LIPINSKI: 0 HAC: 2 HDO: 0 TPSA: 16.13 ALOGS: -3.72 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

chlorphenamine
chloropheniramine
chlorophenylpyridamine
chloroprophenpyridamine
chlorpheniramine
chlorprophenpyridamine
chlorpheniramine maleate
chlorpheniramine tannate
chlorpheniramine polistirex

A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE.

Molecular weight: 274.79
Formula: C16H19ClN2
CLOGP: 3.15
LIPINSKI: 0
HAC: 2
HDO: 0
TPSA: 16.13
ALOGS: -3.72
ROTB: 5

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
12	mg	O
12	mg	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	10 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.48 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	41 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	3.30 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2.50 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.70 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	22 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	3 mg/mL	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
Aug. 15, 1950	FDA	BAYER HEALTHCARE LLC

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
Contraindicated product administered	199.11	10.47	7	67141	217641	63204233
Drug ineffective	194.85	10.47	521	66627	1044244	62377630
Drug intolerance	163.66	10.47	61	67087	308600	63113274
Synovitis	161.15	10.47	9	67139	186909	63234965
Glossodynia	138.96	10.47	14	67134	178862	63243012
Systemic lupus erythematosus	133.34	10.47	29	67119	208889	63212985
Treatment failure	124.28	10.47	29	67119	199014	63222860
Pericarditis	121.10	10.47	4	67144	131575	63290299
Chest discomfort	112.47	10.47	312	66836	109657	63312217
Sinusitis	111.52	10.47	505	66643	226148	63195726
Dyspnoea	111.45	10.47	1127	66021	660186	62761688
Therapeutic product effect decreased	111.38	10.47	33	67115	193154	63228720
Maternal exposure during pregnancy	110.81	10.47	47	67101	220015	63201859
Arthropathy	100.55	10.47	62	67086	234730	63187144
Joint swelling	98.61	10.47	121	67027	327545	63094329
Wound	95.73	10.47	27	67121	163236	63258638
Hepatic enzyme increased	94.45	10.47	48	67100	202280	63219594
Neuropathy peripheral	88.47	10.47	293	66855	113374	63308500
Asthma	88.11	10.47	316	66832	127245	63294629
Cough	88.00	10.47	570	66578	292173	63129701
General physical health deterioration	86.48	10.47	53	67095	201349	63220525
Helicobacter infection	78.31	10.47	5	67143	92780	63329094
Rheumatoid factor positive	76.15	10.47	3	67145	84403	63337471
Rheumatoid arthritis	71.91	10.47	98	67050	253721	63168153
Anaphylactic reaction	69.98	10.47	190	66958	65910	63355964
Discomfort	69.16	10.47	46	67102	167328	63254546
Ejection fraction decreased	59.49	10.47	94	67054	22238	63399636
Sinusitis fungal	56.91	10.47	31	67117	1800	63420074
Flushing	56.13	10.47	191	66957	74896	63346978
Chest pain	52.20	10.47	399	66749	215560	63206314
Diarrhoea	51.35	10.47	1050	66098	714316	62707558
Sputum increased	50.93	10.47	32	67116	2427	63419447
Folliculitis	50.86	10.47	7	67141	70310	63351564
Completed suicide	49.02	10.47	49	67099	145624	63276250
Abdominal discomfort	48.67	10.47	175	66973	320710	63101164
Neutropenic sepsis	47.72	10.47	72	67076	16366	63405508
Product use issue	47.00	10.47	102	67046	220418	63201456
Musculoskeletal stiffness	46.71	10.47	77	67071	184541	63237333
Infective pulmonary exacerbation of cystic fibrosis	46.70	10.47	52	67096	8765	63413109
Salpingo-oophorectomy unilateral	45.35	10.47	21	67127	860	63421014
Deep vein thrombosis	45.13	10.47	192	66956	83608	63338266
Excessive eye blinking	43.51	10.47	23	67125	1257	63420617
Anxiety	42.95	10.47	384	66764	217157	63204717
Eosinophilic colitis	41.61	10.47	13	67135	174	63421700
Nausea	40.98	10.47	1187	65961	853284	62568590
Swelling	39.90	10.47	153	66995	275225	63146649
Back pain	39.43	10.47	440	66708	263705	63158169
Diverticulum	38.39	10.47	55	67093	11936	63409938
Off label use	38.19	10.47	494	66654	673968	62747906
C-reactive protein abnormal	37.40	10.47	3	67145	46093	63375781
Drug interaction	36.72	10.47	122	67026	229009	63192865
Sleep apnoea syndrome	35.19	10.47	88	67060	29045	63392829
Pneumonia	35.18	10.47	678	66470	456089	62965785
Pulmonary embolism	34.83	10.47	227	66921	116457	63305417
Headache	34.62	10.47	895	66253	632346	62789528
Swelling face	34.61	10.47	146	67002	63329	63358545
Bronchitis	34.27	10.47	238	66910	124697	63297177
Toxicity to various agents	34.14	10.47	140	67008	247110	63174764
Impaired healing	33.91	10.47	35	67113	102507	63319367
Upper respiratory tract infection	33.20	10.47	173	66975	81874	63340000
Palpitations	32.82	10.47	218	66930	112552	63309322
Infusion site erythema	32.27	10.47	50	67098	11629	63410245
Product quality issue	32.03	10.47	97	67051	35768	63386106
Bronchospasm	32.03	10.47	62	67086	17218	63404656
Nail infection	31.39	10.47	24	67124	2499	63419375
Oropharyngeal pain	30.80	10.47	188	66960	94299	63327575
Nasal congestion	30.50	10.47	144	67004	65516	63356358
Candida infection	30.50	10.47	82	67066	28269	63393605
Mobility decreased	30.20	10.47	51	67097	121108	63300766
Urinary tract infection	30.07	10.47	419	66729	264265	63157609
Gastrooesophageal reflux disease	29.74	10.47	188	66960	95451	63326423
Mucosal inflammation	29.63	10.47	113	67035	46815	63375059
Nasal polyps	29.24	10.47	34	67114	6005	63415869
Diastolic dysfunction	28.97	10.47	35	67113	6436	63415438
Embolism venous	28.69	10.47	25	67123	3129	63418745
Therapeutic product effect incomplete	28.18	10.47	56	67092	125000	63296874
Dilatation intrahepatic duct acquired	28.17	10.47	14	67134	672	63421202
Emotional distress	28.11	10.47	87	67061	32462	63389412
Blister	27.67	10.47	60	67088	129754	63292120
Chronic sinusitis	27.46	10.47	49	67099	12794	63409080
Red blood cell sedimentation rate increased	26.27	10.47	7	67141	43975	63377899
Chronic obstructive pulmonary disease	25.92	10.47	133	67015	62553	63359321
Liver injury	25.84	10.47	16	67132	60504	63361370
Respiratory symptom	25.48	10.47	24	67124	3323	63418551
Psoriatic arthropathy	25.22	10.47	36	67112	91484	63330390
Dizziness	25.01	10.47	613	66535	429312	62992562
Condition aggravated	24.81	10.47	289	66859	401928	63019946
Throat tightness	24.80	10.47	70	67078	24817	63397057
Necrotic lymphadenopathy	24.63	10.47	7	67141	66	63421808
Vulvovaginal candidiasis	24.62	10.47	23	67125	3152	63418722
C-reactive protein increased	24.41	10.47	39	67109	94668	63327206
Arthralgia	23.47	10.47	443	66705	569267	62852607
Muscle spasms	23.21	10.47	260	66888	155890	63265984
Erythema	23.19	10.47	286	66862	175465	63246409
Infusion site swelling	23.14	10.47	39	67109	9731	63412143
Irritable bowel syndrome	23.12	10.47	32	67116	82380	63339494
Infusion site pruritus	22.82	10.47	30	67118	6005	63415869
Abdominal pain	22.34	10.47	435	66713	293021	63128853
Lip swelling	22.31	10.47	78	67070	30985	63390889
Band sensation	22.31	10.47	13	67135	860	63421014
Wheezing	22.16	10.47	175	66973	95420	63326454
Constipation	21.97	10.47	347	66801	224596	63197278
Hiatus hernia	21.78	10.47	61	67087	21533	63400341
Lacrimation increased	21.52	10.47	59	67089	20572	63401302
Foetal exposure during pregnancy	21.27	10.47	4	67144	31958	63389916
Vascular compression	21.20	10.47	8	67140	194	63421680
Hip arthroplasty	21.18	10.47	12	67136	47634	63374240
Hiccups	20.94	10.47	18	67130	2213	63419661
Gallbladder polyp	20.85	10.47	12	67136	775	63421099
Ill-defined disorder	20.75	10.47	34	67114	81721	63340153
Acute sinusitis	20.72	10.47	23	67125	3864	63418010
Tonsillar hypertrophy	20.66	10.47	13	67135	988	63420886
Sinus disorder	20.62	10.47	65	67083	24488	63397386
Rhinitis allergic	20.43	10.47	41	67107	11686	63410188
Alopecia	20.23	10.47	244	66904	337292	63084582
Migraine	20.14	10.47	182	66966	103164	63318710
Gastroenteritis viral	20.14	10.47	63	67085	23637	63398237
Ear infection	20.13	10.47	87	67061	38126	63383748
Acute respiratory failure	20.12	10.47	81	67067	34404	63387470
Catheter site bruise	20.10	10.47	10	67138	481	63421393
Poor quality device used	20.03	10.47	17	67131	2054	63419820
Retinal detachment	20.03	10.47	28	67120	5941	63415933
Swollen tongue	19.71	10.47	81	67067	34719	63387155
Hypoxia	19.50	10.47	119	67029	59673	63362201
Pain in jaw	19.19	10.47	94	67054	43402	63378472
Hepatocellular injury	19.16	10.47	3	67145	27378	63394496
Biliary sepsis	18.99	10.47	12	67136	919	63420955
Chemical burns of eye	18.96	10.47	6	67142	84	63421790
Hysterectomy	18.74	10.47	35	67113	9464	63412410
Product dose omission issue	18.73	10.47	350	66798	233963	63187911
Panic attack	18.64	10.47	59	67089	22272	63399602
Rhinorrhoea	18.61	10.47	126	67022	65451	63356423
Exposure during pregnancy	18.50	10.47	93	67055	155454	63266420
Diffuse large B-cell lymphoma refractory	18.23	10.47	13	67135	1217	63420657
Infusion site nodule	18.14	10.47	14	67134	1478	63420396
Disease recurrence	18.11	10.47	68	67080	27962	63393912
Coma	18.04	10.47	25	67123	64339	63357535
Emphysema	17.59	10.47	37	67111	10901	63410973
Tricuspid valve incompetence	17.48	10.47	44	67104	14577	63407297
Urticaria	17.42	10.47	259	66889	165543	63256331
Pain	17.39	10.47	625	66523	740003	62681871
Depression	17.29	10.47	298	66850	196194	63225680
Seasonal allergy	17.17	10.47	55	67093	20895	63400979
Iron deficiency anaemia	16.89	10.47	53	67095	19916	63401958
Loss of personal independence in daily activities	16.83	10.47	50	67098	97240	63324634
Tachycardia	16.77	10.47	195	66953	117961	63303913
Type 2 diabetes mellitus	16.74	10.47	26	67122	63842	63358032
Cholecystitis chronic	16.61	10.47	35	67113	10326	63411548
Gastrointestinal disorder	16.46	10.47	77	67071	131162	63290712
Infusion site extravasation	16.46	10.47	35	67113	10391	63411483
Diverticulitis	16.40	10.47	84	67064	39473	63382401
Female genital tract fistula	16.37	10.47	29	67119	7530	63414344
Hyperkalaemia	16.28	10.47	20	67128	54183	63367691
Therapy non-responder	16.24	10.47	35	67113	75866	63346008
Premature delivery	15.98	10.47	6	67142	30275	63391599
Delirium	15.87	10.47	18	67130	50523	63371351
Acute kidney injury	15.55	10.47	191	66957	263224	63158650
Nasal discomfort	15.48	10.47	22	67126	4738	63417136
Nail dystrophy	15.40	10.47	11	67137	1032	63420842
Presyncope	15.21	10.47	64	67084	27721	63394153
Malignant neoplasm progression	15.09	10.47	41	67107	82080	63339794
Feeling hot	15.04	10.47	98	67050	50256	63371618
Agranulocytosis	15.01	10.47	4	67144	25130	63396744
Intentional product use issue	14.91	10.47	77	67071	127815	63294059
Axillary pain	14.68	10.47	14	67134	1969	63419905
Myalgia	14.66	10.47	227	66921	146302	63275572
Laryngospasm	14.58	10.47	17	67131	3011	63418863
Anosmia	14.44	10.47	26	67122	6834	63415040
Inflammation	14.44	10.47	42	67106	82231	63339643
Drug reaction with eosinophilia and systemic symptoms	14.37	10.47	9	67139	33827	63388047
Sopor	14.28	10.47	3	67145	22161	63399713
Disease progression	14.18	10.47	195	66953	122563	63299311
Neutropenia	14.18	10.47	262	66886	174743	63247131
Infusion site mass	14.18	10.47	14	67134	2054	63419820
Acute interstitial pneumonitis	14.18	10.47	9	67139	695	63421179
Prosopagnosia	13.95	10.47	4	67144	39	63421835
Hereditary angioedema	13.85	10.47	27	67121	7535	63414339
Administration site extravasation	13.84	10.47	10	67138	955	63420919
Cellulitis	13.82	10.47	140	67008	81818	63340056
Victim of chemical submission	13.80	10.47	8	67140	524	63421350
Ventricular extrasystoles	13.79	10.47	35	67113	11652	63410222
Haemodialysis complication	13.79	10.47	6	67142	212	63421662
Blood cholesterol increased	13.75	10.47	52	67096	93980	63327894
Myelosuppression	13.73	10.47	4	67144	23699	63398175
Confusional state	13.35	10.47	173	66975	236207	63185667
Haemoptysis	13.34	10.47	63	67085	28663	63393211
Blood creatinine increased	13.22	10.47	48	67100	87796	63334078
Oral pain	12.98	10.47	62	67086	28332	63393542
Transient ischaemic attack	12.86	10.47	76	67072	37677	63384197
Pulmonary fibrosis	12.69	10.47	14	67134	39795	63382079
Biliary dyskinesia	12.61	10.47	15	67133	2714	63419160
Retching	12.51	10.47	39	67109	14606	63407268
Catheter site haemorrhage	12.34	10.47	16	67132	3159	63418715
Genital ulceration	12.27	10.47	8	67140	647	63421227
Tubulointerstitial nephritis	12.21	10.47	3	67145	19900	63401974
Anhedonia	12.06	10.47	32	67116	10942	63410932
Pancreatitis chronic	12.05	10.47	14	67134	2470	63419404
Dyspnoea at rest	12.03	10.47	18	67130	4061	63417813
Dermatitis contact	12	10.47	32	67116	10976	63410898
Autoimmune haemolytic anaemia	11.75	10.47	19	67129	4582	63417292
Vomiting	11.74	10.47	713	66435	558904	62862970
Poor peripheral circulation	11.71	10.47	17	67131	3732	63418142
Cyanosis	11.71	10.47	42	67106	16893	63404981
Low turnover osteopathy	11.68	10.47	18	67130	4167	63417707
Insomnia	11.61	10.47	304	66844	214948	63206926
Gallbladder disorder	11.59	10.47	45	67103	18797	63403077
Hypervolaemia	11.55	10.47	60	67088	28353	63393521
Sinus headache	11.46	10.47	21	67127	5595	63416279
Infusion site bruising	11.43	10.47	17	67131	3815	63418059
Insurance issue	11.39	10.47	22	67126	6099	63415775
Drug resistance	11.36	10.47	5	67143	22928	63398946
Rhinitis	11.35	10.47	32	67116	11334	63410540
Terminal ileitis	11.32	10.47	8	67140	738	63421136
Ageusia	11.21	10.47	36	67112	13692	63408182
Product used for unknown indication	11.21	10.47	7	67141	525	63421349
Prescribed underdose	11.16	10.47	9	67139	29680	63392194
Tongue pruritus	11.14	10.47	7	67141	531	63421343
Blood magnesium decreased	11.14	10.47	35	67113	13163	63408711
Multiple allergies	11.10	10.47	36	67112	13766	63408108
Cholestasis	10.97	10.47	9	67139	29425	63392449
Infusion site pain	10.96	10.47	41	67107	16828	63405046
Sedation	10.95	10.47	15	67133	38794	63383080
Coronary artery disease	10.91	10.47	65	67083	32312	63389562
Stomatitis	10.89	10.47	94	67054	138631	63283243
Grip strength decreased	10.82	10.47	5	67143	22282	63399592
Incorrect route of product administration	10.73	10.47	8	67140	27444	63394430
HER2 positive breast cancer	10.68	10.47	6	67142	370	63421504
Lethargy	10.59	10.47	98	67050	55909	63365965

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
Sinusitis	71.39	11.19	136	33350	41266	34882179
Lower respiratory tract infection	67.45	11.19	114	33372	31523	34891922
Delusion of grandeur	66.72	11.19	29	33457	1131	34922314
Rhinalgia	59.50	11.19	26	33460	1027	34922418
Drug ineffective	56.46	11.19	236	33250	456515	34466930
Upper respiratory tract infection	47.88	11.19	101	33385	32958	34890487
Asthma	41.87	11.19	112	33374	42544	34880901
Painful respiration	40.58	11.19	21	33465	1215	34922230
Infusion related reaction	40.22	11.19	127	33359	52930	34870515
Affective disorder	39.40	11.19	33	33453	4327	34919118
Lymphocyte count abnormal	38.31	11.19	20	33466	1178	34922267
Chest injury	38.26	11.19	22	33464	1569	34921876
Infective pulmonary exacerbation of cystic fibrosis	37.32	11.19	39	33447	6762	34916683
Urticaria	34.87	11.19	135	33351	62242	34861203
Walking aid user	31.94	11.19	21	33465	1903	34921542
Flushing	30.68	11.19	84	33402	32336	34891109
Bronchitis	30.48	11.19	99	33387	41864	34881581
Nasal discomfort	30.07	11.19	19	33467	1609	34921836
General physical health deterioration	29.84	11.19	48	33438	128221	34795224
Cough	28.42	11.19	243	33243	149897	34773548
Dyspnoea	28.29	11.19	512	32974	376270	34547175
Constipation	26.07	11.19	222	33264	136760	34786685
Neutropenic sepsis	25.94	11.19	47	33439	13720	34909725
Dry skin	25.66	11.19	77	33409	31210	34892235
SARS-CoV-2 test positive	25.60	11.19	30	33456	5903	34917542
Failure to anastomose	25.20	11.19	9	33477	206	34923239
Dyspepsia	25.19	11.19	85	33401	36647	34886798
Pneumonia	23.86	11.19	483	33003	362144	34561301
Hypoacusis	23.82	11.19	50	33436	16251	34907194
Feeling cold	23.54	11.19	39	33447	10600	34912845
Toxic epidermal necrolysis	23.45	11.19	59	33427	21587	34901858
Pruritus	22.40	11.19	221	33265	141760	34781685
Cellulitis	22.16	11.19	105	33381	52846	34870599
Oropharyngeal blistering	22.09	11.19	8	33478	191	34923254
Treatment failure	21.32	11.19	9	33477	46688	34876757
Acute kidney injury	21.00	11.19	189	33297	304799	34618646
Lip swelling	20.85	11.19	47	33439	16033	34907412
Lactic acidosis	20.84	11.19	4	33482	34768	34888677
Personality change	20.55	11.19	25	33461	5114	34918331
Hypersomnia	20.44	11.19	40	33446	12367	34911078
Renal failure	20.33	11.19	61	33425	130496	34792949
Nasal congestion	20.10	11.19	58	33428	22999	34900446
Rash	20.06	11.19	312	33174	222440	34701005
Alopecia	20.03	11.19	60	33426	24295	34899150
Drug interaction	18.78	11.19	133	33353	225813	34697632
Therapeutic product effect incomplete	18.34	11.19	13	33473	50528	34872917
Febrile neutropenia	17.39	11.19	204	33282	136645	34786800
Fatigue	17.36	11.19	471	33015	370182	34553263
Drug hypersensitivity	17.19	11.19	134	33352	80395	34843050
Malignant neoplasm progression	16.89	11.19	37	33449	88009	34835436
Seasonal allergy	16.87	11.19	26	33460	6649	34916796
Hypersensitivity	16.78	11.19	108	33378	60927	34862518
Hypoxic-ischaemic encephalopathy	16.45	11.19	21	33465	4511	34918934
Infusion site pruritus	16.19	11.19	10	33476	813	34922632
Cystic fibrosis	15.92	11.19	13	33473	1645	34921800
Wheezing	15.82	11.19	80	33406	41322	34882123
Tonsillitis	15.35	11.19	15	33471	2401	34921044
Oral candidiasis	15.26	11.19	35	33451	12075	34911370
Sputum discoloured	15.13	11.19	27	33459	7785	34915660
HIV associated nephropathy	14.94	11.19	7	33479	326	34923119
Neutropenic infection	14.92	11.19	12	33474	1486	34921959
Limb mass	14.74	11.19	9	33477	717	34922728
Lip dry	14.56	11.19	11	33475	1243	34922202
Schizophrenia	14.35	11.19	28	33458	8638	34914807
Gastroenteritis viral	14.29	11.19	25	33461	7099	34916346
Hyperkalaemia	14.28	11.19	28	33458	69361	34854084
Infusion site erythema	14.23	11.19	14	33472	2259	34921186
Infusion site pain	14.22	11.19	18	33468	3833	34919612
Chest discomfort	14.08	11.19	95	33391	54435	34869010
Stress	14.05	11.19	62	33424	30285	34893160
Abnormal behaviour	13.91	11.19	54	33432	24915	34898530
Aortic aneurysm	13.87	11.19	24	33462	6755	34916690
C-reactive protein increased	13.77	11.19	19	33467	54079	34869366
Sputum increased	13.74	11.19	14	33472	2356	34921089
Productive cough	13.71	11.19	72	33414	37741	34885704
Rhabdomyolysis	13.61	11.19	28	33458	68135	34855310
Dry mouth	13.49	11.19	61	33425	30104	34893341
Hot flush	13.45	11.19	43	33443	18023	34905422
Death	13.19	11.19	286	33200	397763	34525682
Chills	13.18	11.19	127	33359	80916	34842529
Paraesthesia oral	13.01	11.19	18	33468	4179	34919266
Accidental exposure to product by child	12.98	11.19	11	33475	1465	34921980
Off label use	12.61	11.19	306	33180	419218	34504227
Rhinitis allergic	12.46	11.19	15	33471	3035	34920410
Ear infection	12.27	11.19	29	33457	10202	34913243
Swelling face	12.09	11.19	49	33437	23056	34900389
Interstitial lung disease	12.05	11.19	28	33458	65254	34858191
Anaphylactic reaction	12.05	11.19	62	33424	32239	34891206
Incorrect dose administered	11.95	11.19	73	33413	40442	34883003
Ingrowing nail	11.90	11.19	9	33477	1019	34922426
Sinus disorder	11.86	11.19	23	33463	7062	34916383
Cystic fibrosis related diabetes	11.85	11.19	5	33481	181	34923264
Reading disorder	11.68	11.19	7	33479	539	34922906
Otitis media	11.53	11.19	14	33472	2858	34920587
Cerebral infarction	11.44	11.19	6	33480	27449	34895996
Bradycardia foetal	11.42	11.19	6	33480	358	34923087
Neuropathy peripheral	11.41	11.19	126	33360	83137	34840308
Bronchospasm	11.36	11.19	29	33457	10702	34912743

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
Drug ineffective	185.65	9.87	534	81122	1080379	78582353
Contraindicated product administered	135.71	9.87	6	81650	157532	79505200
Dyspnoea	121.10	9.87	1374	80282	855651	78807081
Synovitis	119.90	9.87	9	81647	150725	79512007
Chest discomfort	108.05	9.87	349	81307	137695	79525037
Neuropathy peripheral	102.35	9.87	348	81308	140957	79521775
Drug intolerance	95.69	9.87	78	81578	264041	79398691
Treatment failure	95.46	9.87	28	81628	170458	79492274
Cough	91.02	9.87	665	80991	366124	79296608
General physical health deterioration	89.33	9.87	90	81566	275148	79387584
Pemphigus	85.07	9.87	4	81652	99578	79563154
Pericarditis	83.53	9.87	6	81650	104230	79558502
Infective pulmonary exacerbation of cystic fibrosis	79.39	9.87	81	81575	12770	79649962
Flushing	79.10	9.87	234	81422	88034	79574698
Asthma	74.65	9.87	305	81351	134790	79527942
Joint swelling	70.34	9.87	117	81539	288529	79374203
Neutropenic sepsis	68.02	9.87	109	81547	26955	79635777
Systemic lupus erythematosus	67.62	9.87	20	81636	121129	79541603
Therapeutic product effect decreased	66.34	9.87	43	81613	163820	79498912
Anaphylactic reaction	63.04	9.87	209	81447	83534	79579198
Delusion of grandeur	62.02	9.87	30	81626	1402	79661330
Sputum increased	61.17	9.87	45	81611	4568	79658164
Helicobacter infection	58.90	9.87	3	81653	69701	79593031
Drug interaction	57.21	9.87	225	81431	414958	79247774
Maternal exposure during pregnancy	55.03	9.87	36	81620	136502	79526230
Glossodynia	54.23	9.87	19	81637	103318	79559414
Rheumatoid arthritis	53.12	9.87	82	81574	208388	79454344
Arthropathy	50.78	9.87	64	81592	177047	79485685
Sinusitis	50.44	9.87	358	81298	195143	79467589
Sinusitis fungal	50.35	9.87	31	81625	2343	79660389
Hepatic enzyme increased	50.29	9.87	68	81588	182542	79480190
Chest pain	49.69	9.87	474	81182	281830	79380902
Rheumatoid factor positive	49.24	9.87	3	81653	59836	79602896
Upper respiratory tract infection	48.12	9.87	203	81453	90965	79571767
Salpingo-oophorectomy unilateral	47.11	9.87	21	81635	813	79661919
Pneumonia	46.64	9.87	941	80715	659305	79003427
Pulmonary embolism	45.84	9.87	317	81339	171337	79491395
Constipation	45.80	9.87	467	81189	282583	79380149
Rhinalgia	45.41	9.87	29	81627	2338	79660394
Acute kidney injury	43.65	9.87	332	81324	519072	79143660
Swelling face	42.71	9.87	165	81491	71047	79591685
Deep vein thrombosis	42.08	9.87	239	81417	120680	79542052
Lip swelling	41.05	9.87	113	81543	40798	79621934
Nasal discomfort	38.39	9.87	37	81619	5446	79657286
Ejection fraction decreased	38.23	9.87	99	81557	34478	79628254
C-reactive protein abnormal	38.13	9.87	3	81653	48364	79614368
Excessive eye blinking	38.10	9.87	23	81633	1678	79661054
Therapeutic product effect incomplete	37.74	9.87	54	81602	141591	79521141
Off label use	37.20	9.87	680	80976	906535	78756197
Nausea	35.84	9.87	1255	80401	955941	78706791
C-reactive protein increased	35.56	9.87	48	81608	128979	79533753
Nasal congestion	35.50	9.87	164	81492	76388	79586344
Lacrimation increased	35.46	9.87	74	81582	22403	79640329
Wound	35.41	9.87	40	81616	116139	79546593
Palpitations	35.09	9.87	236	81420	126374	79536358
Musculoskeletal stiffness	34.74	9.87	80	81576	174928	79487804
Completed suicide	34.57	9.87	132	81524	245635	79417097
Anxiety	33.72	9.87	396	81260	248116	79414616
Mucosal inflammation	33.64	9.87	160	81496	75420	79587312
Sleep disorder due to general medical condition, insomnia type	33.51	9.87	3	81653	43553	79619179
Back pain	33.36	9.87	466	81190	303714	79359018
Hyperkalaemia	33.13	9.87	41	81615	114357	79548375
Cellulitis	33.10	9.87	208	81448	108852	79553880
Urticaria	33.07	9.87	312	81344	184889	79477843
Lymphocyte count abnormal	32.83	9.87	20	81636	1483	79661249
Bronchospasm	32.60	9.87	76	81580	24783	79637949
Diarrhoea	32.58	9.87	1153	80503	879336	78783396
Wheezing	32.05	9.87	217	81439	116447	79546285
Sleep apnoea syndrome	31.99	9.87	96	81560	36382	79626350
Product quality issue	31.37	9.87	91	81565	33849	79628883
Gastrooesophageal reflux disease	31.13	9.87	198	81458	104048	79558684
Discomfort	30.49	9.87	51	81605	125566	79537166
Eosinophilic colitis	29.71	9.87	13	81643	481	79662251
Lower respiratory tract infection	29.54	9.87	230	81426	128990	79533742
Renal failure	29.53	9.87	106	81550	200862	79461870
Erythema	29.49	9.87	354	81302	222936	79439796
Oropharyngeal pain	29.20	9.87	202	81454	109151	79553581
Impaired healing	29.16	9.87	28	81628	87627	79575105
Mobility decreased	28.37	9.87	51	81605	122124	79540608
Infusion site erythema	27.85	9.87	41	81615	9419	79653313
Vulvovaginal candidiasis	27.78	9.87	22	81634	2492	79660240
Chest injury	27.61	9.87	23	81633	2798	79659934
Drug resistance	27.45	9.87	5	81651	42208	79620524
Necrotic lymphadenopathy	26.89	9.87	8	81648	93	79662639
Hiatus hernia	26.03	9.87	67	81589	23245	79639487
Urinary tract infection	25.96	9.87	410	81246	274102	79388630
Plethoric face	24.76	9.87	6	81650	29	79662703
Dilatation intrahepatic duct acquired	24.74	9.87	13	81643	725	79662007
Folliculitis	24.57	9.87	13	81643	55367	79607365
Tachycardia	24.42	9.87	284	81372	177484	79485248
Nail infection	24.40	9.87	20	81636	2379	79660353
Gastroenteritis viral	24.33	9.87	68	81588	24763	79637969
Hypoxia	24.28	9.87	185	81471	103058	79559674
Band sensation	23.94	9.87	13	81643	775	79661957
Diastolic dysfunction	23.76	9.87	41	81615	10770	79651962
Infusion site pruritus	23.72	9.87	25	81631	4093	79658639
Sopor	23.54	9.87	3	81653	33007	79629725
Emotional distress	23.46	9.87	92	81564	39877	79622855
Nasal polyps	23.39	9.87	33	81623	7294	79655438
Bronchitis	23.26	9.87	220	81436	130424	79532308
Lactic acidosis	22.80	9.87	23	81633	70336	79592396
Fatigue	22.71	9.87	1166	80490	928561	78734171
Neutropenia	22.58	9.87	417	81239	287293	79375439
Malignant neoplasm progression	22.54	9.87	68	81588	135922	79526810
Rhinitis allergic	22.48	9.87	43	81613	12226	79650506
Headache	22.38	9.87	849	80807	652923	79009809
Female genital tract fistula	22.25	9.87	29	81627	5946	79656786
Febrile neutropenia	22.21	9.87	346	81310	230653	79432079
Myelosuppression	21.85	9.87	7	81649	40289	79622443
Coma	21.63	9.87	44	81612	100605	79562127
Affective disorder	21.58	9.87	34	81622	8285	79654447
Acute sinusitis	21.57	9.87	25	81631	4545	79658187
Red blood cell sedimentation rate increased	21.57	9.87	10	81646	45932	79616800
Dry skin	21.45	9.87	131	81525	67864	79594868
Oral candidiasis	21.45	9.87	73	81583	29555	79633177
Embolism venous	21.38	9.87	24	81632	4215	79658517
Blood creatinine increased	21.33	9.87	84	81572	154973	79507759
Throat tightness	21.30	9.87	70	81586	27837	79634895
Condition aggravated	21.28	9.87	373	81283	500751	79161981
Interstitial lung disease	21.13	9.87	53	81603	112547	79550185
Catheter site bruise	21.07	9.87	10	81646	448	79662284
Respiratory symptom	20.62	9.87	25	81631	4766	79657966
Chronic obstructive pulmonary disease	20.61	9.87	154	81502	85265	79577467
Product use issue	20.61	9.87	128	81528	209694	79453038
Blood pressure fluctuation	20.58	9.87	23	81633	67122	79595610
Hypersomnia	20.47	9.87	61	81595	23025	79639707
Gastrointestinal disorder	20.33	9.87	61	81595	122144	79540588
Loss of personal independence in daily activities	20.26	9.87	47	81609	102533	79560199
Failure to anastomose	20.24	9.87	8	81648	228	79662504
Painful respiration	19.95	9.87	21	81635	3432	79659300
Hysterectomy	19.65	9.87	28	81628	6244	79656488
Psoriatic arthropathy	19.55	9.87	31	81625	77968	79584764
Chronic sinusitis	19.52	9.87	42	81614	12984	79649748
Feeling cold	19.25	9.87	69	81587	28660	79634072
Delirium	19.05	9.87	36	81620	84591	79578141
Dizziness	18.55	9.87	686	80970	525755	79136977
Candida infection	18.55	9.87	83	81573	38131	79624601
Migraine	18.50	9.87	153	81503	87340	79575392
Rhinorrhoea	18.27	9.87	137	81519	75937	79586795
Cystic fibrosis	17.94	9.87	21	81635	3859	79658873
Diverticulum	17.87	9.87	44	81612	14852	79647880
Pruritus	17.40	9.87	528	81128	394120	79268612
Chemical burns of eye	17.31	9.87	6	81650	117	79662615
Renal impairment	17.23	9.87	93	81563	157690	79505042
Poor quality device used	17.10	9.87	16	81640	2269	79660463
Panic attack	16.95	9.87	59	81597	24157	79638575
Tubulointerstitial nephritis	16.93	9.87	9	81647	38226	79624506
Arthralgia	16.90	9.87	451	81205	571352	79091380
SARS-CoV-2 test positive	16.67	9.87	37	81619	11679	79651053
Lethargy	16.57	9.87	141	81515	81151	79581581
Pyrexia	16.48	9.87	851	80805	677858	78984874
Bradycardia	16.46	9.87	77	81579	135480	79527252
Hip arthroplasty	16.45	9.87	8	81648	35748	79626984
Sinus headache	16.39	9.87	23	81633	5057	79657675
Irritable bowel syndrome	16.30	9.87	24	81632	62217	79600515
Haemorrhoids	16.26	9.87	66	81590	29062	79633670
Blister	16.25	9.87	65	81591	119411	79543321
Gallbladder polyp	16.24	9.87	11	81645	979	79661753
Hot flush	16.23	9.87	104	81552	54773	79607959
Paraesthesia oral	16.21	9.87	52	81604	20419	79642313
Vascular compression	16.15	9.87	9	81647	565	79662167
Product dose omission issue	16.15	9.87	349	81307	247188	79415544
Therapy non-responder	16.14	9.87	45	81611	92260	79570472
Rhabdomyolysis	16.08	9.87	53	81603	103078	79559654
Nail dystrophy	16.01	9.87	11	81645	1002	79661730
Pulmonary fibrosis	15.99	9.87	13	81643	44099	79618633
Sinus disorder	15.95	9.87	55	81601	22409	79640323
Toxicity to various agents	15.95	9.87	320	81336	421220	79241512
Abdominal discomfort	15.89	9.87	172	81484	250555	79412177
Tonsillar hypertrophy	15.84	9.87	13	81643	1549	79661183
Myalgia	15.59	9.87	272	81384	185369	79477363
Inflammation	15.45	9.87	47	81609	93706	79569026
Swollen tongue	15.37	9.87	85	81571	42485	79620247
Product prescribing error	15.27	9.87	14	81642	44799	79617933
Pain in jaw	15.25	9.87	90	81566	46061	79616671
Incorrect dose administered	15.14	9.87	132	81524	76498	79586234
Infusion site swelling	15.05	9.87	28	81628	7798	79654934
Cholecystitis chronic	14.91	9.87	32	81624	9874	79652858
Bicuspid aortic valve	14.90	9.87	4	81652	31	79662701
Presyncope	14.84	9.87	82	81574	40972	79621760
Cyanosis	14.81	9.87	58	81598	25124	79637608
Vomiting	14.80	9.87	828	80828	665000	78997732
Intentional product misuse to child	14.69	9.87	5	81651	92	79662640
Dyspnoea exertional	14.69	9.87	145	81511	86928	79575804
Dyspepsia	14.63	9.87	173	81483	108514	79554218
Product use in unapproved indication	14.59	9.87	175	81481	250184	79412548
Feeling hot	14.58	9.87	108	81548	59626	79603106
Eosinophilia	14.49	9.87	15	81641	45330	79617402
HIV associated nephropathy	14.42	9.87	7	81649	330	79662402
Hypoacusis	14.27	9.87	65	81591	30085	79632647
Laryngospasm	14.26	9.87	19	81637	3978	79658754
Oxygen saturation decreased	14.24	9.87	198	81458	128849	79533883
Seasonal allergy	14.22	9.87	43	81613	16363	79646369
Pancreatitis chronic	14.18	9.87	19	81637	4000	79658732
Acute respiratory failure	14.17	9.87	107	81549	59434	79603298
Retinal detachment	14.07	9.87	30	81626	9217	79653515
Poor peripheral circulation	13.91	9.87	18	81638	3665	79659067
Prosopagnosia	13.90	9.87	4	81652	41	79662691
Seizure	13.88	9.87	271	81385	188563	79474169
Biliary dyskinesia	13.86	9.87	15	81641	2530	79660202
Toxic skin eruption	13.74	9.87	3	81653	22290	79640442
Victim of chemical submission	13.74	9.87	8	81648	546	79662186
Liver injury	13.72	9.87	23	81633	56591	79606141
Infusion site mass	13.58	9.87	12	81644	1581	79661151
Pelvic infection	13.55	9.87	7	81649	377	79662355
Rash macular	13.46	9.87	62	81594	28837	79633895
Altered state of consciousness	13.44	9.87	15	81641	43807	79618925
Biliary sepsis	13.42	9.87	12	81644	1605	79661127
Disease recurrence	13.30	9.87	84	81572	44025	79618707
Agranulocytosis	13.18	9.87	16	81640	45014	79617718
Ill-defined disorder	13.16	9.87	30	81626	65845	79596887
Rhinitis	13.01	9.87	39	81617	14768	79647964
Blood pressure systolic increased	12.98	9.87	31	81625	66955	79595777
Neuralgia	12.96	9.87	68	81588	33316	79629416
Suffocation feeling	12.79	9.87	12	81644	1708	79661024
Neutropenic infection	12.69	9.87	14	81642	2413	79660319
Abdominal pain	12.60	9.87	503	81153	389066	79273666
Emphysema	12.54	9.87	41	81615	16259	79646473
Pancytopenia	12.48	9.87	109	81547	165636	79497096
Ear canal erythema	12.47	9.87	3	81653	14	79662718
Tympanic membrane hyperaemia	12.47	9.87	3	81653	14	79662718
Insomnia	12.45	9.87	334	81322	244836	79417896
Muscle spasms	12.25	9.87	249	81407	174481	79488251
Accidental exposure to product by child	12.16	9.87	15	81641	2911	79659821
Infusion site pain	12.14	9.87	37	81619	14139	79648593
Hyperpyrexia	11.97	9.87	22	81634	6070	79656662
Otitis media	11.93	9.87	22	81634	6084	79656648
Iron deficiency anaemia	11.90	9.87	55	81601	25617	79637115
Failure of child resistant product closure	11.89	9.87	4	81652	71	79662661
Bronchopulmonary aspergillosis	11.86	9.87	4	81652	22290	79640442
Mood swings	11.86	9.87	46	81610	19834	79642898
Oral pain	11.82	9.87	64	81592	31734	79630998
Depression	11.78	9.87	298	81358	216492	79446240
Haemodialysis complication	11.74	9.87	6	81650	316	79662416
Paraesthesia	11.62	9.87	249	81407	176074	79486658
Reading disorder	11.57	9.87	9	81647	993	79661739
Sinus tachycardia	11.57	9.87	71	81585	36837	79625895
Device dislocation	11.57	9.87	55	81601	25915	79636817
Confusional state	11.54	9.87	243	81413	317754	79344978
COVID-19	11.49	9.87	226	81430	157448	79505284
Hypervolaemia	11.47	9.87	79	81577	42611	79620121
HER2 positive breast cancer	11.46	9.87	6	81650	332	79662400
Drug ineffective for unapproved indication	11.35	9.87	22	81634	51216	79611516
Administration site extravasation	11.22	9.87	10	81646	1333	79661399
Intentional self-injury	11.20	9.87	10	81646	32409	79630323
Oropharyngeal blistering	11.20	9.87	8	81648	776	79661956
Diverticulitis	11.18	9.87	83	81573	45853	79616879
Vision blurred	11.09	9.87	161	81495	105737	79556995
Cholestasis	11.01	9.87	23	81633	52086	79610646
Tongue pruritus	10.97	9.87	7	81649	563	79662169
Retching	10.90	9.87	41	81615	17426	79645306
Creatinine renal clearance decreased	10.85	9.87	3	81653	18999	79643733
Genital ulceration	10.83	9.87	9	81647	1091	79661641
Blood pressure diastolic decreased	10.83	9.87	9	81647	30207	79632525
Productive cough	10.76	9.87	138	81518	88193	79574539
Catheter site haemorrhage	10.72	9.87	19	81637	5098	79657634
Cardiac failure	10.72	9.87	104	81552	154738	79507994
Product complaint	10.65	9.87	34	81622	13315	79649417
Cystic fibrosis related diabetes	10.60	9.87	5	81651	221	79662511
Axillary pain	10.56	9.87	12	81644	2137	79660595
Multiple organ dysfunction syndrome	10.47	9.87	76	81580	120170	79542562
Exposure during pregnancy	10.28	9.87	61	81595	101071	79561661
Periorbital oedema	10.27	9.87	25	81631	8377	79654355
Hyperlipidaemia	10.02	9.87	53	81603	26040	79636692
Inappropriate schedule of product administration	10.00	9.87	88	81568	133540	79529192
Shock haemorrhagic	10.00	9.87	4	81652	20056	79642676
Stress	9.97	9.87	125	81531	79487	79583245
Grip strength decreased	9.90	9.87	5	81651	21864	79640868

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	R06AB04	RESPIRATORY SYSTEM ANTIHISTAMINES FOR SYSTEMIC USE ANTIHISTAMINES FOR SYSTEMIC USE Substituted alkylamines
ATC	R06AB54	RESPIRATORY SYSTEM ANTIHISTAMINES FOR SYSTEMIC USE ANTIHISTAMINES FOR SYSTEMIC USE Substituted alkylamines
FDA MoA	N0000000190	Histamine H1 Receptor Antagonists
FDA EPC	N0000175587	Histamine-1 Receptor Antagonist
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:35469	antidepressants
CHEBI has role	CHEBI:37955	H1 receptor antagonists
CHEBI has role	CHEBI:37956	antihistamines
CHEBI has role	CHEBI:50857	anti-allergic drugs
CHEBI has role	CHEBI:50949	SSRI
CHEBI has role	CHEBI:59683	antipruritic drugs

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

Disease	Relation	SNOMED_ID	DOID
Dermatographic urticaria	indication	7632005	DOID:743
Vasomotor rhinitis	indication	8229003	DOID:4730
Allergic rhinitis	indication	61582004
Nasal discharge	indication	64531003
Nasal congestion	indication	68235000
Sneezing	indication	76067001
Common cold	indication	82272006	DOID:10459
Urticaria	indication	126485001
Influenza-like symptoms	indication	315642008
Seasonal allergic rhinitis	indication	367498001
Itching of skin	indication	418363000
Allergic conjunctivitis	indication	473460002	DOID:11204
Brain damage	contraindication	2470005
Necrotizing enterocolitis in fetus OR newborn	contraindication	2707005
Goiter	contraindication	3716002	DOID:12176
Ocular hypertension	contraindication	4210003	DOID:9282
Gastritis	contraindication	4556007	DOID:4029
Tachyarrhythmia	contraindication	6285003
Suicidal thoughts	contraindication	6471006
Dependent drug abuse	contraindication	6525002
Urinary tract obstruction	contraindication	7163005	DOID:5200
Alcoholism	contraindication	7200002
Alcohol withdrawal delirium	contraindication	8635005
Peptic ulcer	contraindication	13200003	DOID:750
Chronic obstructive lung disease	contraindication	13645005	DOID:3083
Asthenia	contraindication	13791008
Hyperkalemia	contraindication	14140009
Severe chronic ulcerative colitis	contraindication	14311001
Constipation	contraindication	14760008	DOID:2089
Disorder of autonomic nervous system	contraindication	15241006
Chronic disease of respiratory system	contraindication	17097001
Mood swings	contraindication	18963009
Hashimoto thyroiditis	contraindication	21983002
Myocardial infarction	contraindication	22298006	DOID:5844
Glaucoma	contraindication	23986001	DOID:1686
Inflammatory bowel disease	contraindication	24526004	DOID:0050589
Ventricular tachycardia	contraindication	25569003
Acute tuberculosis	contraindication	25629007
Alcohol intoxication	contraindication	25702006
Shock	contraindication	27942005
Toxic megacolon	contraindication	28536002	DOID:1770
Atony of colon	contraindication	29479008
Hypercapnia	contraindication	29596007
Bronchitis	contraindication	32398004	DOID:6132
Dehydration	contraindication	34095006
Hyperthyroidism	contraindication	34486009	DOID:7998
Acute hepatitis	contraindication	37871000
Hypertensive disorder	contraindication	38341003	DOID:10763
Hypovolemic shock	contraindication	39419009
Disorder of gallbladder	contraindication	39621005	DOID:0060262
Gastrointestinal ulcer	contraindication	40845000
Hypothyroidism	contraindication	40930008	DOID:1459
Complete trisomy 21 syndrome	contraindication	41040004	DOID:14250
Body fluid retention	contraindication	43498006
Conduction disorder of the heart	contraindication	44808001
Low blood pressure	contraindication	45007003
Achalasia of esophagus	contraindication	45564002	DOID:9164
Chronic heart failure	contraindication	48447003
Bradycardia	contraindication	48867003
Disorder of cardiovascular system	contraindication	49601007	DOID:1287
Acidosis	contraindication	51387008
Gastrointestinal perforation	contraindication	51875005
Vitamin K deficiency	contraindication	52675005	DOID:11249
Nasal polyp	contraindication	52756005
Coronary arteriosclerosis	contraindication	53741008	DOID:3393
Paralytic ileus	contraindication	55525008	DOID:8442
Peptic reflux disease	contraindication	57643001
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Ulcerative colitis	contraindication	64766004	DOID:8577
Blood coagulation disorder	contraindication	64779008	DOID:1247
Arterial thrombosis	contraindication	65198009
Drug AND/OR toxin-induced diarrhea	contraindication	65979008
Substance abuse	contraindication	66214007
Benign intracranial hypertension	contraindication	68267002	DOID:11459
Psychotic disorder	contraindication	69322001
Poisoning by acetaminophen	contraindication	70273001
Agoraphobia	contraindication	70691001	DOID:593
Arteriosclerotic vascular disease	contraindication	72092001
Diabetes mellitus	contraindication	73211009	DOID:9351
Factor II deficiency	contraindication	73975000
Reye's syndrome	contraindication	74351001	DOID:14525
Gastrointestinal hemorrhage	contraindication	74474003
Urethral stricture	contraindication	76618002
Thrombotic thrombocytopenic purpura	contraindication	78129009	DOID:10772
Spastic paralysis	contraindication	78403003
Disturbance of salivary secretion	contraindication	78948009
Decreased respiratory function	contraindication	80954004
Injury of head	contraindication	82271004
Chronic idiopathic constipation	contraindication	82934008
Cor pulmonale	contraindication	83291003	DOID:8515
Hiatal hernia	contraindication	84089009	DOID:12642
Epilepsy	contraindication	84757009	DOID:1826
Pulmonary emphysema	contraindication	87433001
Gout	contraindication	90560007	DOID:13189
Kidney disease	contraindication	90708001	DOID:557
Thyrotoxicosis	contraindication	90739004	DOID:7997
Hemophilia	contraindication	90935002
Myasthenia gravis	contraindication	91637004	DOID:437
Dermatitis herpetiformis	contraindication	111196000	DOID:8505
Anemia due to enzyme deficiency	contraindication	111577008
Acute abdominal pain	contraindication	116290004
Procedure on urinary system	contraindication	118677009
Gastrointestinal obstruction	contraindication	126765001
Neoplasm of brain	contraindication	126952004	DOID:1319
von Willebrand disorder	contraindication	128105004	DOID:12531
Seizure disorder	contraindication	128613002
Autonomic dysreflexia	contraindication	129618003
Bleeding	contraindication	131148009
Drug-induced psychosis	contraindication	191483003	DOID:1742
Obsessive-compulsive disorder	contraindication	191736004	DOID:10933
Insomnia	contraindication	193462001
Partial atrioventricular block	contraindication	195039008
Acute pancreatitis	contraindication	197456007	DOID:2913
Impaired renal function disorder	contraindication	197663003
Coronary artery bypass graft	contraindication	232717009
Myocardial dysfunction	contraindication	233928007
Gastroesophageal reflux disease	contraindication	235595009	DOID:8534
Disease of liver	contraindication	235856003	DOID:409
Bladder outflow obstruction	contraindication	236645006
Morbid obesity	contraindication	238136002	DOID:11981
Hypocomplementemic urticarial vasculitis	contraindication	239945009
Pyloric obstruction	contraindication	244815007
Benign prostatic hyperplasia	contraindication	266569009
Retention of urine	contraindication	267064002
Anemia	contraindication	271737000	DOID:2355
Drowsy	contraindication	271782001
Exacerbation of asthma	contraindication	281239006
Pregnancy, function	contraindication	289908002
Lesion of brain	contraindication	301766008
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Panic disorder	contraindication	371631005	DOID:594
Coma	contraindication	371632003
Primary adrenocortical insufficiency	contraindication	373662000
Operation on gastrointestinal tract	contraindication	386621005
Hypoxia	contraindication	389086002
Angle-closure glaucoma	contraindication	392291006	DOID:13550
Cardiovascular event risk	contraindication	395112001
Pseudomembranous enterocolitis	contraindication	397683000
Gastric ulcer	contraindication	397825006	DOID:10808
Breastfeeding (mother)	contraindication	413712001
Chronic lung disease	contraindication	413839001
Chronic myocardial ischemia	contraindication	413844008	DOID:3393
Disorder of coronary artery	contraindication	414024009
Myocardial ischemia	contraindication	414795007	DOID:3393
Myocardial infarction in recovery phase	contraindication	418044006
Central nervous system depression	contraindication	418072004
Ultrarapid metabolizer due to cytochrome p450 CYP2D6 variant	contraindication	422681000
Fever greater than 100.4 Fahrenheit	contraindication	426000000
Dysfunction of sphincter of Oddi	contraindication	430887001
Hypertensive urgency	contraindication	443482000
Acute erosive gastritis	contraindication	444926003
Smokes tobacco daily	contraindication	449868002
Acute exacerbation of asthma	contraindication	708038006
Acute Thromboembolic Stroke	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.47	Basic
pKa2	4.14	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
8MG;54.3MG	TUXARIN ER	MAINPOINTE	N206323	June 22, 2015	RX	TABLET, EXTENDED RELEASE	ORAL	9066942	Jan. 3, 2032	TREATMENT OF COUGH AND SYMPTOMS ASSOCIATED WITH UPPER RESPIRATORY ALLERGIES OR A COMMON COLD WITH CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ORALLY ADMINISTERED EXTENDED RELEASE TABLETS

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	8.15	WOMBAT-PK	CHEMBL
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN		Kd	7.82	WOMBAT-PK
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		Ki	5.17	PDSP
Histamine H4 receptor	GPCR	Q9H3N8	HRH4_HUMAN		Ki	6.67	WOMBAT-PK
Cytochrome P450 2D6	Enzyme	P10635	CP2D6_HUMAN		Ki	4.97	WOMBAT-PK
Sodium channel alpha subunits; brain (Types I, II, III)	Ion channel	P35498 Q99250 Q9NY46	SCN1A_HUMAN SCN2A_HUMAN SCN3A_HUMAN		IC50	5	CHEMBL
Lethal(3)malignant brain tumor-like protein 1	Unclassified	Q9Y468	LMBL1_HUMAN		IC50	4.39	CHEMBL
Lethal(3)malignant brain tumor-like protein 3	Unclassified	Q96JM7	LMBL3_HUMAN		IC50	4.38	CHEMBL
MBT domain-containing protein 1	Unclassified	Q05BQ5	MBTD1_HUMAN		IC50	4.47	CHEMBL
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Kd	5.84	SCIENTIFIC LITERATURE
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	5.96	CHEMBL
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		Kd	5.98	SCIENTIFIC LITERATURE
Histamine H1 receptor	GPCR		HRH1_CAVPO		IC50	8.06	CHEMBL
Histamine H1 receptor	GPCR		HRH1_RAT		Ki	8.70	CHEMBL
Chloroquine resistance transporter	Transporter		CRT_PLAFA		IC50	4.27	CHEMBL

External reference:

ID	Source
4017865	VUID
N0000146218	NUI
D00665	KEGG_DRUG
113-92-8	SECONDARY_CAS_RN
1405-56-7	SECONDARY_CAS_RN
142429	RXNORM
4017864	VANDF
4017865	VANDF
4018446	VANDF
4019408	VANDF
C0008281	UMLSCUI
CHEBI:52010	CHEBI
CHEMBL505	ChEMBL_ID
CHEMBL1659	ChEMBL_ID
DB01114	DRUGBANK_ID
6976	IUPHAR_LIGAND_ID
2725	PUBCHEM_CID
32347	MMSL
32562	MMSL
3966	MMSL
4425	MMSL
4426	MMSL
4427	MMSL
4751	MMSL
93262	MMSL
d00191	MMSL
003391	NDDF
003392	NDDF
004430	NDDF
004431	NDDF
372914003	SNOMEDCT_US
438256006	SNOMEDCT_US
85737002	SNOMEDCT_US
9944001	SNOMEDCT_US
D002744	MESH_DESCRIPTOR_UI
CHEMBL1201659	ChEMBL_ID
104	INN_ID
3U6IO1965U	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Childrens Robitussin Nighttime Cough Long-Acting DM	HUMAN OTC DRUG LABEL	2	0031-8692	SOLUTION	2 mg	ORAL	OTC monograph final	17 sections
Childrens Robitussin Nighttime Cough Long-Acting DM	HUMAN OTC DRUG LABEL	2	0031-8692	SOLUTION	2 mg	ORAL	OTC monograph final	17 sections
Childrens Robitussin Nighttime Cough Long-Acting DM	HUMAN OTC DRUG LABEL	2	0031-8692	SOLUTION	2 mg	ORAL	OTC monograph final	17 sections
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING	HUMAN OTC DRUG LABEL	2	0031-8693	LIQUID	1 mg	ORAL	OTC monograph final	17 sections
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING	HUMAN OTC DRUG LABEL	2	0031-8693	LIQUID	2 mg	ORAL	OTC monograph final	17 sections
TriaminicMulti-Symptom Fever and Cold	HUMAN OTC DRUG LABEL	4	0067-8116	SUSPENSION	1 mg	ORAL	OTC monograph final	15 sections
Theraflu Flu Relief Max StrengthNighttime	HUMAN OTC DRUG LABEL	3	0067-8205	SYRUP	4 mg	ORAL	OTC monograph final	17 sections
good sense cold	HUMAN OTC DRUG LABEL	4	0113-0903	SUSPENSION	1 mg	ORAL	OTC monograph final	15 sections
Allergy	HUMAN OTC DRUG LABEL	3	0113-2476	TABLET	2 mg	ORAL	OTC monograph final	15 sections
basic care childrens cold plus flu	HUMAN OTC DRUG LABEL	4	0113-7223	SUSPENSION	1 mg	ORAL	OTC monograph final	15 sections
FLONASEHeadache and Allergy Relief	HUMAN OTC DRUG LABEL	3	0135-0578	TABLET	2 mg	ORAL	OTC monograph final	17 sections
TussiCaps	HUMAN PRESCRIPTION DRUG LABEL	2	0187-0054	CAPSULE, EXTENDED RELEASE	4 mg	ORAL	ANDA	24 sections
TussiCaps	HUMAN PRESCRIPTION DRUG LABEL	2	0187-0108	CAPSULE, EXTENDED RELEASE	8 mg	ORAL	ANDA	24 sections
Alka-Seltzer Plus Severe Cold PowerFast FizzOrange Zest	HUMAN OTC DRUG LABEL	3	0280-0020	TABLET, EFFERVESCENT	2 mg	ORAL	OTC monograph final	17 sections
Alka-Seltzer Plus Severe Cold PowerFast FizzOrange Zest	HUMAN OTC DRUG LABEL	3	0280-0020	TABLET, EFFERVESCENT	2 mg	ORAL	OTC monograph final	17 sections
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	HUMAN OTC DRUG LABEL	4	0280-0022	TABLET, EFFERVESCENT	2 mg	ORAL	OTC monograph final	16 sections
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	HUMAN OTC DRUG LABEL	4	0280-0022	TABLET, EFFERVESCENT	2 mg	ORAL	OTC monograph final	16 sections
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	HUMAN OTC DRUG LABEL	4	0280-0022	TABLET, EFFERVESCENT	2 mg	ORAL	OTC monograph final	16 sections
Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz	HUMAN OTC DRUG LABEL	4	0280-0023	TABLET, EFFERVESCENT	2 mg	ORAL	OTC monograph final	16 sections
Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz	HUMAN OTC DRUG LABEL	4	0280-0023	TABLET, EFFERVESCENT	2 mg	ORAL	OTC monograph final	16 sections
Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz	HUMAN OTC DRUG LABEL	4	0280-0023	TABLET, EFFERVESCENT	2 mg	ORAL	OTC monograph final	16 sections
ANTIFLU	HUMAN OTC DRUG LABEL	3	0280-0044	TABLET, COATED	2 mg	ORAL	Export only	2 sections
Antiflupowder	HUMAN OTC DRUG LABEL	3	0280-0045	POWDER, FOR SOLUTION	4 mg	ORAL	Export only	1 sections
Antiflu Kids	HUMAN OTC DRUG LABEL	3	0280-0046	POWDER, FOR SOLUTION	1 mg	ORAL	Export only	2 sections
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz	HUMAN OTC DRUG LABEL	4	0280-0055	TABLET, EFFERVESCENT	2 mg	ORAL	OTC monograph final	15 sections
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz	HUMAN OTC DRUG LABEL	4	0280-0055	TABLET, EFFERVESCENT	2 mg	ORAL	OTC monograph final	15 sections
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz	HUMAN OTC DRUG LABEL	4	0280-0055	TABLET, EFFERVESCENT	2 mg	ORAL	OTC monograph final	15 sections
Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz	HUMAN OTC DRUG LABEL	3	0280-0060	TABLET, EFFERVESCENT	2 mg	ORAL	OTC monograph final	15 sections
Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz	HUMAN OTC DRUG LABEL	3	0280-0060	TABLET, EFFERVESCENT	2 mg	ORAL	OTC monograph final	15 sections
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	HUMAN OTC DRUG LABEL	4	0280-0088	TABLET, EFFERVESCENT	2 mg	ORAL	OTC monograph final	16 sections