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

Stem definition	Drug id	CAS RN
bronchodilators, phenethylamine derivatives	1239	73573-87-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: eformoterol formoterol formoterol fumarate formoterol fumarate dihydrate formoterol fumarate hydrate	An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE. Molecular weight: 344.41 Formula: C19H24N2O4 CLOGP: 1.26 LIPINSKI: 0 HAC: 6 HDO: 4 TPSA: 90.82 ALOGS: -3.92 ROTB: 8 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

eformoterol
formoterol
formoterol fumarate
formoterol fumarate dihydrate
formoterol fumarate hydrate

An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

Molecular weight: 344.41
Formula: C19H24N2O4
CLOGP: 1.26
LIPINSKI: 0
HAC: 6
HDO: 4
TPSA: 90.82
ALOGS: -3.92
ROTB: 8

Status: OFP

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

Drug dosage:

Dose	Unit	Route
24	mcg	Inhal.aerosol
24	mcg	Inhal.powder
0.16	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.66 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	8 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.00 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

Date	Agency	Company
Feb. 16, 2001	FDA	NOVARTIS
June 18, 2019	PMDA	AstraZeneca K.K.
April 28, 2014	EMA	Teva Pharma B.V.

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
Asthma	978.79	13.40	655	29187	112115	56150110
Product quality issue	649.81	13.40	323	29519	31413	56230812
Dyspnoea	486.00	13.40	1005	28837	591572	55670653
Wheezing	332.97	13.40	293	29549	74733	56187492
Chronic obstructive pulmonary disease	262.21	13.40	228	29614	57187	56205038
Obstructive airways disorder	253.91	13.40	141	29701	17141	56245084
Cough	231.59	13.40	458	29384	259503	56002722
No adverse event	169.11	13.40	146	29696	36228	56225997
Chest discomfort	169.09	13.40	234	29608	98623	56163602
Polycystic ovaries	150.14	13.40	59	29783	3255	56258970
Sleep apnoea syndrome	138.46	13.40	113	29729	25948	56236277
Nasal polyps	137.01	13.40	55	29787	3210	56259015
Product dose omission issue	122.44	13.40	308	29534	204445	56057780
Gastrooesophageal reflux disease	118.88	13.40	181	29661	83076	56179149
Emphysema	118.76	13.40	71	29771	9905	56252320
Productive cough	105.02	13.40	139	29703	56093	56206132
Sputum increased	103.96	13.40	40	29802	2084	56260141
Rheumatoid arthritis	103.34	13.40	37	29805	382567	55879658
Salpingo-oophorectomy unilateral	98.11	13.40	29	29813	663	56261562
Sinusitis fungal	93.41	13.40	34	29808	1516	56260709
Respiratory symptom	90.12	13.40	39	29803	2751	56259474
Candida infection	89.98	13.40	88	29754	25579	56236646
Rhinitis allergic	89.82	13.40	56	29786	8418	56253807
Sensitisation	86.10	13.40	36	29806	2332	56259893
Off label use	85.20	13.40	102	29740	556078	55706147
Asthmatic crisis	82.97	13.40	32	29810	1678	56260547
Embolism venous	82.89	13.40	37	29805	2811	56259414
Ejection fraction	82.88	13.40	32	29810	1683	56260542
Eosinophilic granulomatosis with polyangiitis	80.57	13.40	33	29809	2028	56260197
Eczema	79.47	13.40	83	29759	26070	56236155
Systemic lupus erythematosus	78.92	13.40	4	29838	180074	56082151
Hyper IgE syndrome	78.47	13.40	22	29820	414	56261811
Skin candida	78.14	13.40	29	29813	1367	56260858
Blood test abnormal	75.50	13.40	59	29783	12725	56249500
Joint swelling	70.12	13.40	33	29809	289767	55972458
Dysphonia	68.21	13.40	97	29745	41850	56220375
Female genital tract fistula	66.90	13.40	37	29805	4455	56257770
Bronchospasm	65.02	13.40	59	29783	15610	56246615
Mycobacterium avium complex infection	63.99	13.40	31	29811	2838	56259387
Treatment failure	63.05	13.40	8	29834	170384	56091841
Restrictive pulmonary disease	61.59	13.40	25	29817	1501	56260724
Alopecia	60.12	13.40	41	29801	293417	55968808
Arthropathy	60.03	13.40	16	29826	200259	56061966
Diastolic dysfunction	59.06	13.40	37	29805	5608	56256617
Drug intolerance	58.36	13.40	34	29808	264784	55997441
Dyspnoea exertional	57.93	13.40	104	29738	54585	56207640
Sputum discoloured	57.71	13.40	53	29789	14239	56247986
Hepatic enzyme increased	54.67	13.40	12	29830	171372	56090853
Chronic sinusitis	54.59	13.40	41	29801	8337	56253888
Toxicity to various agents	53.64	13.40	26	29816	224538	56037687
Pain	52.93	13.40	178	29664	663006	55599219
Pneumonia	51.83	13.40	381	29461	406717	55855508
Pulmonary mass	51.79	13.40	59	29783	20411	56241814
Diverticulum	50.55	13.40	44	29798	11022	56251203
Oedema peripheral	48.95	13.40	200	29642	171054	56091171
Hypothyroidism	48.85	13.40	79	29763	38117	56224108
Hiatus hernia	48.63	13.40	56	29786	19596	56242629
Sleep disorder due to a general medical condition	47.39	13.40	39	29803	9051	56253174
Bronchiectasis	47.33	13.40	43	29799	11391	56250834
Product use issue	45.24	13.40	21	29821	186020	56076205
Product container issue	44.87	13.40	20	29822	1514	56260711
Abdominal discomfort	44.32	13.40	49	29793	277225	55985000
Neurosensory hypoacusis	43.35	13.40	12	29830	215	56262010
Pericarditis	43.11	13.40	4	29838	108919	56153306
Infusion related reaction	43.01	13.40	29	29813	208902	56053323
Nephrectomy	42.62	13.40	18	29824	1195	56261030
Pulmonary function test decreased	41.29	13.40	25	29817	3566	56258659
Tricuspid valve incompetence	40.15	13.40	42	29800	13211	56249014
Swelling	39.84	13.40	41	29801	239730	56022495
White blood cell count decreased	39.81	13.40	9	29833	125981	56136244
Arthralgia	39.70	13.40	135	29707	501534	55760691
Hysterectomy	38.92	13.40	34	29808	8557	56253668
Full blood count abnormal	36.97	13.40	57	29785	26405	56235820
Facial nerve disorder	36.55	13.40	13	29829	542	56261683
Intentional product use issue	36.12	13.40	5	29837	99728	56162497
CFTR gene mutation	36.09	13.40	9	29833	105	56262120
Iron deficiency anaemia	36.08	13.40	46	29796	17873	56244352
Rhinitis	35.87	13.40	33	29809	8883	56253342
Glossodynia	35.86	13.40	18	29824	152440	56109785
Musculoskeletal stiffness	35.83	13.40	19	29823	155988	56106237
Drug ineffective	35.77	13.40	314	29528	918675	55343550
Fatigue	35.47	13.40	259	29583	788293	55473932
Feeling jittery	34.40	13.40	37	29805	12009	56250216
Peripheral swelling	33.77	13.40	45	29797	234681	56027544
Burning sensation	33.01	13.40	77	29765	48619	56213606
Discomfort	32.94	13.40	17	29825	141744	56120481
Therapeutic product effect decreased	32.93	13.40	25	29817	169427	56092798
Product taste abnormal	32.16	13.40	17	29825	1871	56260354
Pulmonary embolism	32.09	13.40	127	29715	106997	56155228
Heart rate increased	31.94	13.40	107	29735	83166	56179059
Lipohypertrophy	31.43	13.40	12	29830	612	56261613
Respiratory tract infection	31.27	13.40	63	29779	36008	56226217
Transient ischaemic attack	30.74	13.40	60	29782	33517	56228708
Dyslipidaemia	30.52	13.40	26	29816	6327	56255898
Bronchopulmonary aspergillosis allergic	30.38	13.40	15	29827	1431	56260794
Pulmonary congestion	30.31	13.40	40	29802	16075	56246150
Urinary tract discomfort	30.26	13.40	10	29832	333	56261892
Drug hypersensitivity	29.27	13.40	64	29778	275141	55987084
Increased bronchial secretion	28.88	13.40	15	29827	1592	56260633
Febrile neutropenia	28.77	13.40	10	29832	105535	56156690
Peak expiratory flow rate decreased	28.05	13.40	11	29831	603	56261622
Impaired healing	27.84	13.40	6	29836	86835	56175390
Congenital naevus	27.27	13.40	8	29834	178	56262047
Bronchitis chronic	27.06	13.40	20	29822	3968	56258257
Throat tightness	26.83	13.40	45	29797	22362	56239863
Peripheral vascular disorder	26.62	13.40	23	29819	5702	56256523
Oropharyngeal pain	26.44	13.40	101	29741	83687	56178538
Swollen tongue	26.33	13.40	53	29789	30271	56231954
Blood electrolytes abnormal	26.13	13.40	12	29830	974	56261251
Nervous system disorder	25.90	13.40	38	29804	16851	56245374
Limb injury	25.71	13.40	44	29798	22226	56239999
Increased upper airway secretion	25.69	13.40	18	29824	3286	56258939
Osteoporosis	25.65	13.40	73	29769	51979	56210246
Angioplasty	25.58	13.40	13	29829	1319	56260906
Skin lesion	25.42	13.40	50	29792	28085	56234140
Diarrhoea	25.26	13.40	217	29625	638290	55623935
Cardiac disorder	25.24	13.40	67	29775	45820	56216405
Alveolar osteitis	25.21	13.40	10	29832	565	56261660
Breast neoplasm	25.18	13.40	13	29829	1363	56260862
Underdose	24.92	13.40	45	29797	23712	56238513
Throat irritation	24.73	13.40	54	29788	32629	56229596
Anaphylactic reaction	24.60	13.40	78	29764	58917	56203308
Coronary artery disease	24.59	13.40	52	29790	30744	56231481
Breath sounds abnormal	24.56	13.40	27	29815	8980	56253245
Hypomagnesaemia	24.49	13.40	46	29796	24969	56237256
Incorrect dose administered	24.26	13.40	72	29770	52475	56209750
Psoriatic arthropathy	23.95	13.40	5	29837	74003	56188222
Drug abuse	23.09	13.40	4	29838	67606	56194619
Circumstance or information capable of leading to medication error	22.74	13.40	17	29825	3431	56258794
Infection	22.59	13.40	45	29797	200161	56062064
Carpal tunnel syndrome	22.48	13.40	37	29805	18107	56244118
Therapy partial responder	22.39	13.40	24	29818	7761	56254464
Lung neoplasm malignant	22.26	13.40	36	29806	17360	56244865
Pharyngeal oedema	21.99	13.40	31	29811	13254	56248971
Female reproductive neoplasm	21.98	13.40	5	29837	38	56262187
Middle insomnia	21.87	13.40	28	29814	10922	56251303
Hypertension	21.62	13.40	211	29631	244067	56018158
Tunnel vision	21.48	13.40	10	29832	837	56261388
Choking	21.19	13.40	25	29817	8972	56253253
Disease recurrence	21.07	13.40	42	29800	23818	56238407
Palpitations	20.68	13.40	106	29736	99566	56162659
Bronchitis	20.30	13.40	115	29727	112196	56150029
Allergic sinusitis	20.28	13.40	9	29833	674	56261551
Renal disorder	20.26	13.40	47	29795	29558	56232667
Neutropenic sepsis	20.22	13.40	32	29810	15153	56247072
Device malfunction	20.12	13.40	33	29809	16103	56246122
Fungal infection	20.03	13.40	50	29792	32943	56229282
Disease progression	19.81	13.40	16	29826	105157	56157068
Ear congestion	19.65	13.40	13	29829	2162	56260063
Carnitine deficiency	19.64	13.40	6	29836	154	56262071
Bordetella test positive	19.63	13.40	3	29839	0	56262225
Animal scratch	19.28	13.40	10	29832	1058	56261167
Ejection fraction abnormal	19.00	13.40	10	29832	1090	56261135
Kyphosis	18.98	13.40	13	29829	2289	56259936
Restless legs syndrome	18.93	13.40	33	29809	16914	56245311
Psoriasis	18.87	13.40	13	29829	92679	56169546
Infective exacerbation of chronic obstructive airways disease	18.83	13.40	10	29832	1111	56261114
Lip pruritus	18.78	13.40	9	29833	804	56261421
Macrocytosis	18.66	13.40	13	29829	2353	56259872
Device ineffective	18.47	13.40	6	29836	189	56262036
Pancreatitis relapsing	18.37	13.40	9	29833	844	56261381
Respiratory tract congestion	18.25	13.40	31	29811	15560	56246665
Oligohydramnios	18.16	13.40	19	29823	5975	56256250
Foreign body aspiration	18.03	13.40	6	29836	204	56262021
Intentional overdose	17.64	13.40	7	29835	68110	56194115
Spirometry abnormal	17.42	13.40	6	29836	227	56261998
Tubulointerstitial nephritis and uveitis syndrome	17.37	13.40	6	29836	229	56261996
Condition aggravated	17.04	13.40	110	29732	344788	55917437
Deep vein thrombosis	16.77	13.40	83	29759	76894	56185331
Depression	16.62	13.40	157	29685	179960	56082265
Oedema mouth	16.61	13.40	12	29830	2298	56259927
Bladder pain	16.55	13.40	11	29831	1843	56260382
Stomatitis	16.52	13.40	24	29818	120786	56141439
Urinary retention	16.47	13.40	42	29800	28032	56234193
Forced expiratory volume decreased	16.37	13.40	16	29826	4644	56257581
Mobility decreased	16.34	13.40	17	29825	98974	56163251
Dysphagia	16.20	13.40	86	29756	81861	56180364
Respiratory disorder	16.12	13.40	47	29795	33910	56228315
Rales	16.06	13.40	24	29818	10816	56251409
Myocardial infarction	16.06	13.40	94	29748	92776	56169449
Blood immunoglobulin E increased	15.87	13.40	13	29829	2996	56259229
Gastrointestinal disorder	15.79	13.40	22	29820	112680	56149545
Crepitations	15.78	13.40	19	29823	6965	56255260
Hypotension	15.59	13.40	74	29768	250434	56011791
Malignant neoplasm progression	15.41	13.40	10	29832	73577	56188648
Abscess	15.10	13.40	28	29814	15053	56247172
Eosinophilia	14.99	13.40	33	29809	20044	56242181
Haemoptysis	14.82	13.40	39	29803	26521	56235704
Irritable bowel syndrome	14.76	13.40	9	29833	68449	56193776
Blister	14.52	13.40	22	29820	108865	56153360
Presbyacusis	14.42	13.40	12	29830	2826	56259399
Neutropenia	14.28	13.40	40	29802	158127	56104098
Mouth ulceration	14.05	13.40	41	29801	29599	56232626
Haemorrhage	13.87	13.40	63	29779	56334	56205891
Hypoaesthesia oral	13.74	13.40	23	29819	11408	56250817
Platelet count decreased	13.71	13.40	22	29820	106361	56155864
Left ventricular hypertrophy	13.69	13.40	15	29827	4969	56257256
Nasal inflammation	13.60	13.40	6	29836	443	56261782
Long QT syndrome	13.58	13.40	12	29830	3064	56259161
Polymyalgia rheumatica	13.56	13.40	12	29830	3070	56259155
Plasma cell myeloma	13.45	13.40	4	29838	46642	56215583
Wound complication	13.41	13.40	12	29830	3116	56259109

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
Asthma	553.03	13.67	317	16068	42294	31638665
Product quality issue	407.28	13.67	188	16197	15923	31665036
Chronic obstructive pulmonary disease	293.53	13.67	218	16167	44948	31636011
Dyspnoea	271.25	13.67	565	15820	342914	31338045
No adverse event	157.88	13.67	108	16277	19517	31661442
Nasal obstruction	155.81	13.67	40	16345	544	31680415
Wheezing	147.63	13.67	133	16252	35853	31645106
Sinus pain	117.85	13.67	33	16352	635	31680324
Asthma-chronic obstructive pulmonary disease overlap syndrome	106.65	13.67	33	16352	909	31680050
Eosinophilic granulomatosis with polyangiitis	92.58	13.67	34	16351	1597	31679362
Emphysema	91.04	13.67	57	16328	8861	31672098
Cough	89.73	13.67	208	16177	134606	31546353
Pulmonary function test decreased	85.86	13.67	43	16342	4342	31676617
Throat irritation	79.01	13.67	53	16332	9261	31671698
Mycobacterium avium complex infection	76.20	13.67	33	16352	2393	31678566
Product dose omission issue	71.38	13.67	164	16221	105422	31575537
Bronchiectasis	71.27	13.67	46	16339	7534	31673425
Chest discomfort	67.82	13.67	104	16281	49265	31631694
Sputum discoloured	63.41	13.67	41	16344	6735	31674224
Hepatic vein dilatation	62.42	13.67	16	16369	216	31680743
Eosinophil count	60.50	13.67	14	16371	119	31680840
Respiratory disorder	59.63	13.67	59	16326	17841	31663118
Vocal cord dysfunction	57.76	13.67	14	16371	148	31680811
Osteopenia	54.43	13.67	32	16353	4439	31676520
Liver palpable	54.09	13.67	15	16370	278	31680681
Lung consolidation	50.92	13.67	33	16352	5440	31675519
Suffocation feeling	48.86	13.67	16	16369	531	31680428
Obstructive airways disorder	48.34	13.67	45	16340	12619	31668340
Atrial enlargement	46.91	13.67	14	16371	340	31680619
Toxicity to various agents	44.65	13.67	19	16366	181468	31499491
Ventricular enlargement	43.18	13.67	14	16371	450	31680509
Nasal congestion	41.61	13.67	52	16333	20329	31660630
Inferior vena cava dilatation	41.55	13.67	15	16370	670	31680289
Pulmonary mass	40.90	13.67	39	16346	11267	31669692
Hangover	39.68	13.67	16	16369	969	31679990
Dyspnoea at rest	39.67	13.67	24	16361	3507	31677452
Panic reaction	37.72	13.67	17	16368	1355	31679604
Sputum increased	36.10	13.67	19	16366	2126	31678833
Sleep disorder due to a general medical condition	35.01	13.67	23	16362	3879	31677080
Chest pain	33.27	13.67	134	16251	116823	31564136
Bronchial hyperreactivity	30.75	13.67	15	16370	1430	31679529
Bronchial obstruction	30.60	13.67	15	16370	1445	31679514
Bronchospasm	29.79	13.67	31	16354	9941	31671018
Full blood count abnormal	29.13	13.67	39	16346	16308	31664651
Forced expiratory volume decreased	27.82	13.67	18	16367	2959	31678000
Toxic neuropathy	26.61	13.67	10	16375	501	31680458
Stridor	26.49	13.67	16	16369	2331	31678628
Fungal oesophagitis	26.40	13.67	9	16376	339	31680620
Weaning failure	25.43	13.67	8	16377	233	31680726
Product prescribing error	25.02	13.67	40	16345	19602	31661357
Product container issue	24.64	13.67	10	16375	616	31680343
Foreign body aspiration	24.07	13.67	7	16378	155	31680804
Oedema mouth	23.96	13.67	12	16373	1211	31679748
Underdose	23.88	13.67	31	16354	12576	31668383
Heart rate irregular	23.80	13.67	33	16352	14256	31666703
Drug abuse	23.52	13.67	8	16377	87750	31593209
Platelet count decreased	23.47	13.67	14	16371	110421	31570538
Nasal polyps	23.44	13.67	14	16371	1999	31678960
Pneumonia	23.29	13.67	270	16115	335042	31345917
Rales	22.54	13.67	25	16360	8614	31672345
Palpitations	22.52	13.67	53	16332	34530	31646429
Oedema	22.24	13.67	60	16325	42501	31638458
Neutropenia	22.08	13.67	24	16361	140340	31540619
Respiratory tract haemorrhage	21.69	13.67	11	16374	1140	31679819
Cockroach allergy	21.56	13.67	5	16380	43	31680916
Spontaneous haemorrhage	21.10	13.67	7	16378	242	31680717
Adrenal cortex necrosis	20.73	13.67	4	16381	12	31680947
Breath sounds abnormal	20.64	13.67	20	16365	5892	31675067
Cardiac failure chronic	20.56	13.67	22	16363	7281	31673678
Bronchial disorder	20.04	13.67	11	16374	1338	31679621
Orthostatic intolerance	19.72	13.67	9	16376	739	31680220
Necrotising ulcerative gingivostomatitis	19.34	13.67	5	16380	70	31680889
Product taste abnormal	19.23	13.67	10	16375	1091	31679868
Diarrhoea	18.95	13.67	106	16279	352303	31328656
Nasal turbinate hypertrophy	18.72	13.67	5	16380	80	31680879
Dysphonia	18.53	13.67	36	16349	20555	31660404
Therapeutic product effect incomplete	18.39	13.67	57	16328	43639	31637320
Circumstance or information capable of leading to medication error	18.28	13.67	11	16374	1592	31679367
Increased upper airway secretion	18.00	13.67	11	16374	1637	31679322
Oedema peripheral	17.66	13.67	107	16278	109732	31571227
Laryngeal cryptococcosis	17.63	13.67	3	16382	3	31680956
Death	17.51	13.67	112	16273	360457	31320502
Pulmonary congestion	17.31	13.67	27	16358	12956	31668003
Complicated appendicitis	16.70	13.67	4	16381	40	31680919
Nocturnal dyspnoea	16.34	13.67	7	16378	494	31680465
Aphonia	16.10	13.67	13	16372	3012	31677947
Rebound effect	15.98	13.67	12	16373	2501	31678458
Aortic dissection	15.94	13.67	12	16373	2510	31678449
Paradoxical drug reaction	15.72	13.67	13	16372	3116	31677843
Coronary artery stenosis	15.55	13.67	21	16364	8849	31672110
Product use in unapproved indication	15.54	13.67	17	16368	99154	31581805
Infective exacerbation of chronic obstructive airways disease	15.16	13.67	10	16375	1698	31679261
Febrile neutropenia	14.93	13.67	25	16360	121824	31559135
Disease progression	14.74	13.67	15	16370	90449	31590510
Productive cough	14.34	13.67	44	16341	33496	31647463
Arthritis allergic	14.34	13.67	3	16382	15	31680944
Paranasal sinus mucosal hypertrophy	14.18	13.67	4	16381	79	31680880
Therapeutic drug monitoring analysis incorrectly performed	13.95	13.67	4	16381	84	31680875
Plasma cell myeloma	13.74	13.67	6	16379	56525	31624434
Sleep apnoea syndrome	13.74	13.67	30	16355	18595	31662364

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
Asthma	947.08	12.21	643	34579	120150	70773072
Dyspnoea	489.27	12.21	1134	34088	768926	70124296
Chronic obstructive pulmonary disease	367.45	12.21	306	34916	77335	70815887
Wheezing	324.11	12.21	310	34912	93860	70799362
Cough	255.95	12.21	524	34698	324853	70568369
Product quality issue	251.42	12.21	168	35054	30393	70862829
Obstructive airways disorder	206.29	12.21	140	35082	25973	70867249
Emphysema	174.75	12.21	103	35119	14957	70878265
Eosinophilic granulomatosis with polyangiitis	166.56	12.21	62	35160	3151	70890071
Chest discomfort	159	12.21	248	34974	124133	70769089
Polycystic ovaries	154.69	12.21	57	35165	2815	70890407
Nasal polyps	146.10	12.21	62	35160	4454	70888768
Sleep apnoea syndrome	144.44	12.21	124	35098	32589	70860633
Sputum increased	118.91	12.21	52	35170	4020	70889202
Gastrooesophageal reflux disease	113.08	12.21	179	35043	90660	70802562
Productive cough	99.76	12.21	156	35066	78181	70815041
Sputum discoloured	98.93	12.21	79	35143	18772	70874450
Salpingo-oophorectomy unilateral	93.06	12.21	27	35195	618	70892604
Pulmonary function test decreased	90.86	12.21	51	35171	6750	70886472
Toxicity to various agents	87.82	12.21	40	35182	382132	70511090
Nasal obstruction	87.13	12.21	32	35190	1565	70891657
Rhinitis allergic	81.01	12.21	53	35169	9242	70883980
Sensitisation	80.16	12.21	34	35188	2439	70890783
Sinusitis fungal	78.84	12.21	32	35190	2053	70891169
Bronchospasm	78.21	12.21	75	35147	22717	70870505
Respiratory symptom	78.19	12.21	38	35184	3743	70889479
Bronchiectasis	77.17	12.21	64	35158	16033	70877189
Hyper IgE syndrome	77.04	12.21	22	35200	475	70892747
Ejection fraction	76.93	12.21	30	35192	1732	70891490
Asthma-chronic obstructive pulmonary disease overlap syndrome	73.17	12.21	28	35194	1536	70891686
Skin candida	73.05	12.21	29	35193	1756	70891466
Female genital tract fistula	72.75	12.21	34	35188	3069	70890153
Embolism venous	68.73	12.21	35	35187	3810	70889412
Asthmatic crisis	68.11	12.21	28	35194	1856	70891366
Blood test abnormal	67.86	12.21	57	35165	14533	70878689
Sinus pain	66.96	12.21	32	35190	3037	70890185
Eczema	64.96	12.21	82	35140	33699	70859523
Rheumatoid arthritis	63.26	12.21	33	35189	291772	70601450
Off label use	63.23	12.21	176	35046	742884	70150338
Completed suicide	60.08	12.21	19	35203	227116	70666106
Candida infection	58.99	12.21	79	35143	34394	70858828
Eosinophil count	57.29	12.21	13	35209	105	70893117
Hepatic vein dilatation	57.16	12.21	15	35207	233	70892989
Dyspnoea exertional	56.35	12.21	122	35100	78308	70814914
Restrictive pulmonary disease	56.34	12.21	26	35196	2280	70890942
Oedema peripheral	54.47	12.21	241	34981	227850	70665372
Full blood count abnormal	53.98	12.21	75	35147	33803	70859419
Chronic sinusitis	52.16	12.21	39	35183	8412	70884810
Liver palpable	52.05	12.21	15	35207	335	70892887
Joint swelling	51.46	12.21	31	35191	253180	70640042
Dysphonia	49.38	12.21	89	35133	50011	70843211
Sleep disorder due to a general medical condition	48.86	12.21	41	35181	10435	70882787
Pneumonia	47.99	12.21	479	34743	595753	70297469
Intentional product use issue	47.74	12.21	3	35219	120139	70773083
Diastolic dysfunction	46.25	12.21	38	35184	9395	70883827
Hypothyroidism	46.01	12.21	82	35140	45673	70847549
Throat irritation	44.49	12.21	70	35152	35234	70857988
Respiratory disorder	44.44	12.21	74	35148	39049	70854173
Breath sounds abnormal	44.37	12.21	43	35179	13188	70880034
Neurosensory hypoacusis	44.29	12.21	12	35210	212	70893010
Drug abuse	43.29	12.21	10	35212	147246	70745976
Ventricular enlargement	42.01	12.21	14	35208	512	70892710
Hysterectomy	41.73	12.21	29	35193	5583	70887639
Febrile neutropenia	41.52	12.21	25	35197	204293	70688929
Arthropathy	40.66	12.21	12	35210	150045	70743177
Pulmonary mass	40.53	12.21	57	35165	25976	70867246
Inferior vena cava dilatation	40.05	12.21	15	35207	775	70892447
Nephrectomy	39.95	12.21	19	35203	1784	70891438
Vocal cord dysfunction	39.72	12.21	13	35209	449	70892773
Diverticulum	39.48	12.21	41	35181	13652	70879570
Mycobacterium avium complex infection	38.62	12.21	25	35197	4281	70888941
Atrial enlargement	38.35	12.21	14	35208	673	70892549
Contraindicated product administered	37.89	12.21	10	35212	134602	70758620
Feeling jittery	37.75	12.21	37	35185	11506	70881716
Tricuspid valve incompetence	37.06	12.21	45	35177	17772	70875450
Hiatus hernia	37.02	12.21	49	35173	21085	70872137
Bronchial obstruction	36.61	12.21	20	35202	2510	70890712
Treatment failure	36.45	12.21	13	35209	144129	70749093
Pain	35.62	12.21	176	35046	628640	70264582
Product use issue	35.20	12.21	23	35199	179914	70713308
Forced expiratory volume decreased	34.89	12.21	29	35193	7285	70885937
Facial nerve disorder	34.25	12.21	13	35209	697	70892525
Osteoporosis	33.89	12.21	75	35147	48832	70844390
Rales	33.58	12.21	42	35180	17093	70876129
Musculoskeletal stiffness	33.05	12.21	16	35206	147744	70745478
Suffocation feeling	32.80	12.21	16	35206	1588	70891634
Product container issue	32.69	12.21	14	35208	1028	70892194
CFTR gene mutation	32.55	12.21	8	35214	94	70893128
Bronchopulmonary aspergillosis allergic	32.53	12.21	17	35205	1952	70891270
Dyspnoea at rest	32.45	12.21	27	35195	6792	70886430
Alopecia	31.77	12.21	31	35191	198459	70694763
Lung consolidation	31.69	12.21	29	35193	8277	70884945
Chest pain	31.40	12.21	223	34999	251037	70642185
Breast neoplasm	31.24	12.21	13	35209	889	70892333
Pericarditis	31.16	12.21	3	35219	84702	70808520
Platelet count decreased	30.71	12.21	26	35196	178196	70715026
Pulmonary congestion	30.48	12.21	49	35173	25105	70868117
White blood cell count decreased	30.34	12.21	24	35198	170117	70723105
Increased bronchial secretion	30.33	12.21	19	35203	3074	70890148
Hangover	29.98	12.21	16	35206	1917	70891305
Systemic lupus erythematosus	29.78	12.21	7	35215	101895	70791327
Swollen tongue	29.35	12.21	60	35162	36986	70856236
Drug intolerance	28.92	12.21	42	35180	225645	70667577
Lipohypertrophy	28.61	12.21	12	35210	837	70892385
Infusion related reaction	28.13	12.21	34	35188	197500	70695722
Disease progression	28.06	12.21	22	35200	156650	70736572
Urinary tract discomfort	28	12.21	10	35212	451	70892771
Peripheral vascular disorder	27.87	12.21	26	35196	7606	70885616
Bronchitis chronic	27.72	12.21	20	35202	4084	70889138
Neutropenia	27.30	12.21	54	35168	257102	70636120
Increased upper airway secretion	27.02	12.21	19	35203	3726	70889496
Eosinophilia	27.00	12.21	61	35161	40258	70852964
Nasal congestion	26.25	12.21	82	35140	65590	70827632
Stridor	26.05	12.21	21	35201	5055	70888167
Transient ischaemic attack	25.89	12.21	65	35157	45879	70847343
Diarrhoea	25.72	12.21	257	34965	783084	70110138
Alveolar osteitis	25.71	12.21	10	35212	573	70892649
Peripheral swelling	25.70	12.21	49	35173	236514	70656708
Limb injury	25.69	12.21	46	35176	25706	70867516
Angioplasty	25.41	12.21	14	35208	1786	70891436
Rhinitis	25.39	12.21	30	35192	11517	70881705
Palpitations	24.88	12.21	115	35107	110638	70782584
Hepatic enzyme increased	24.57	12.21	25	35197	156965	70736257
Peak expiratory flow rate decreased	24.47	12.21	10	35212	653	70892569
Bronchial disorder	24.45	12.21	15	35207	2339	70890883
Pulmonary embolism	24.12	12.21	146	35076	155721	70737501
Heart rate increased	23.68	12.21	110	35112	106038	70787184
Foreign body aspiration	23.63	12.21	8	35214	307	70892915
Plasma cell myeloma	23.54	12.21	4	35218	73197	70820025
Carpal tunnel syndrome	23.14	12.21	35	35187	17022	70876200
Pharyngeal oedema	22.43	12.21	33	35189	15663	70877559
Cockroach allergy	22.41	12.21	6	35216	101	70893121
Oropharyngeal pain	22.37	12.21	101	35121	96209	70797013
Fungal oesophagitis	22.13	12.21	10	35212	835	70892387
Psoriatic arthropathy	22.06	12.21	3	35219	64768	70828454
Burning sensation	22.05	12.21	67	35155	52803	70840419
Toxic neuropathy	21.76	12.21	10	35212	868	70892354
Oedema mouth	21.51	12.21	15	35207	2903	70890319
Skin lesion	21.24	12.21	54	35168	38406	70854816
Therapeutic product effect decreased	21.01	12.21	24	35198	142994	70750228
Respiratory tract haemorrhage	20.75	12.21	12	35210	1680	70891542
Dyslipidaemia	20.66	12.21	25	35197	9835	70883387
Bronchial hyperreactivity	20.54	12.21	14	35208	2612	70890610
Throat tightness	20.38	12.21	41	35181	24981	70868241
Iron deficiency anaemia	20.24	12.21	39	35183	23033	70870189
Nervous system disorder	20.19	12.21	40	35182	24106	70869116
Adrenal cortex necrosis	20.00	12.21	4	35218	16	70893206
Blood electrolytes abnormal	19.98	12.21	12	35210	1802	70891420
Bordetella test positive	19.83	12.21	3	35219	0	70893222
Crepitations	19.76	12.21	23	35199	8691	70884531
Allergic sinusitis	19.71	12.21	8	35214	513	70892709
Ear congestion	19.62	12.21	13	35209	2314	70890908
Syncope	19.49	12.21	145	35077	165564	70727658
Infection	19.30	12.21	48	35174	210737	70682485
Middle insomnia	19.30	12.21	29	35193	14024	70879198
Rebound effect	19.26	12.21	19	35203	5952	70887270
Sepsis	19.19	12.21	60	35162	244485	70648737
Arthralgia	19.15	12.21	159	35063	503231	70389991
Cardiac disorder	19.15	12.21	69	35153	59346	70833876
Animal scratch	19.04	12.21	10	35212	1160	70892062
Psoriasis	18.68	12.21	13	35209	98420	70794802
Tunnel vision	18.56	12.21	10	35212	1221	70892001
Product dose omission issue	18.52	12.21	177	35045	217291	70675931
Product use in unapproved indication	18.41	12.21	48	35174	207430	70685792
Sinusitis	18.20	12.21	145	35077	169050	70724172
Product taste abnormal	18.17	12.21	12	35210	2124	70891098
Weaning failure	17.83	12.21	8	35214	657	70892565
Urinary retention	17.79	12.21	62	35160	52458	70840764
Macrocytosis	17.76	12.21	13	35209	2714	70890508
Laryngeal cryptococcosis	17.75	12.21	3	35219	3	70893219
Orthostatic intolerance	17.69	12.21	11	35211	1756	70891466
Lower respiratory tract infection	17.41	12.21	105	35117	111808	70781414
Lung neoplasm malignant	17.20	12.21	38	35184	24704	70868518
Therapeutic product effect incomplete	17.11	12.21	110	35112	119772	70773450
Carnitine deficiency	16.99	12.21	6	35216	262	70892960
Respiratory tract congestion	16.93	12.21	31	35191	17622	70875600
Drug hypersensitivity	16.87	12.21	70	35152	262389	70630833
Essential hypertension	16.86	12.21	17	35205	5467	70887755
Kyphosis	16.84	12.21	12	35210	2404	70890818
Pyrexia	16.76	12.21	207	35015	606745	70286477
Circumstance or information capable of leading to medication error	16.64	12.21	14	35208	3576	70889646
Anosmia	16.62	12.21	16	35206	4867	70888355
Lip pruritus	16.61	12.21	8	35214	772	70892450
Encephalopathy	16.57	12.21	5	35217	61656	70831566
Panic reaction	16.47	12.21	15	35207	4256	70888966
Bladder pain	16.43	12.21	11	35211	1993	70891229
Infective exacerbation of chronic obstructive airways disease	16.42	12.21	12	35210	2499	70890723
Spontaneous haemorrhage	16.37	12.21	7	35215	512	70892710
Intentional overdose	16.18	12.21	15	35207	98420	70794802
Respiratory tract infection	16.08	12.21	52	35170	42346	70850876
Restless legs syndrome	15.98	12.21	31	35191	18397	70874825
Product prescribing error	15.90	12.21	49	35173	38903	70854319
Presbyacusis	15.89	12.21	12	35210	2625	70890597
Tubulointerstitial nephritis and uveitis syndrome	15.86	12.21	6	35216	319	70892903
Heart rate irregular	15.64	12.21	41	35181	29702	70863520
Hypomagnesaemia	15.47	12.21	50	35172	40714	70852508
Choking	15.44	12.21	23	35199	11037	70882185
Pancreatitis relapsing	15.34	12.21	8	35214	915	70892307
Anxiety	15.28	12.21	172	35050	220158	70673064
Cardiac failure chronic	15.27	12.21	22	35200	10247	70882975
COVID-19	15.26	12.21	18	35204	105739	70787483
Impaired healing	15.24	12.21	9	35213	74365	70818857
Ejection fraction abnormal	15.23	12.21	10	35212	1753	70891469
Bronchitis	15.17	12.21	105	35117	117138	70776084
Haemoptysis	15.11	12.21	58	35164	51394	70841828
Coma	15.09	12.21	14	35208	91830	70801392
Lip swelling	15.00	12.21	44	35178	34010	70859212
Nasal inflammation	14.91	12.21	7	35215	638	70892584
Anaphylactic reaction	14.78	12.21	75	35147	74899	70818323
Renal disorder	14.77	12.21	47	35175	37962	70855260
Hypertension	14.58	12.21	217	35005	295816	70597406
Status asthmaticus	14.58	12.21	8	35214	1013	70892209
Coronary artery stenosis	14.54	12.21	23	35199	11621	70881601
Restlessness	14.50	12.21	50	35172	42078	70851144
Fungal infection	14.26	12.21	46	35176	37421	70855801
Arthritis allergic	14.14	12.21	3	35219	17	70893205
Discomfort	14.11	12.21	19	35203	105417	70787805
Type 2 diabetes mellitus	14.04	12.21	51	35171	44029	70849193
Cushingoid	14.00	12.21	19	35203	8369	70884853
Paranasal sinus mucosal hypertrophy	13.98	12.21	4	35218	87	70893135
Fatigue	13.88	12.21	308	34914	824011	70069211
Neutropenic sepsis	13.85	12.21	35	35187	24795	70868427
Aortic dissection	13.84	12.21	13	35209	3834	70889388
Stomatitis	13.61	12.21	27	35195	128484	70764738
Swelling	13.59	12.21	48	35174	188491	70704731
Dust allergy	13.47	12.21	8	35214	1176	70892046
Mobility decreased	13.35	12.21	19	35203	102980	70790242
Panic attack	13.21	12.21	32	35190	22087	70871135
Depression	13.19	12.21	154	35068	198820	70694402
Gastrointestinal disorder	13.12	12.21	20	35202	105407	70787815
Bone marrow failure	13.12	12.21	4	35218	49006	70844216
Death	12.94	12.21	177	35045	509884	70383338
Mouth ulceration	12.91	12.21	42	35180	34307	70858915
Thrombocytopenia	12.87	12.21	68	35154	239042	70654180
Tracheo-oesophageal fistula	12.75	12.21	6	35216	550	70892672
Oral candidiasis	12.72	12.21	34	35188	24918	70868304
Red blood cell count decreased	12.68	12.21	5	35217	52156	70841066
Face and mouth X-ray abnormal	12.65	12.21	3	35219	30	70893192
Coronary artery disease	12.53	12.21	63	35159	62673	70830549
Complicated appendicitis	12.37	12.21	4	35218	133	70893089
Nocturnal dyspnoea	12.29	12.21	8	35214	1383	70891839
Hypotension	12.27	12.21	135	35087	404246	70488976

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
Congenital naevus	27.87	15.89	5	6	70	89711

Pharmacologic Action:

Source	Code	Description
ATC	R03AC13	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Selective beta-2-adrenoreceptor agonists
ATC	R03AK07	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AK08	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AK09	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AK11	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AL05	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03AL07	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03AL09	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03AL10	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03AL11	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03CC15	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS FOR SYSTEMIC USE Selective beta-2-adrenoreceptor agonists
FDA MoA	N0000009922	Adrenergic beta2-Agonists
CHEBI has role	CHEBI:35522	beta-adrenergic agonists
CHEBI has role	CHEBI:35523	bronchodilator
CHEBI has role	CHEBI:49167	anti-asthmatic drugs
MeSH PA	D018663	Adrenergic Agents
MeSH PA	D000322	Adrenergic Agonists
MeSH PA	D058666	Adrenergic beta-2 Receptor Agonists
MeSH PA	D000318	Adrenergic beta-Agonists
MeSH PA	D018927	Anti-Asthmatic Agents
MeSH PA	D001993	Bronchodilator Agents
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D019141	Respiratory System Agents
FDA EPC	N0000175779	beta2-Adrenergic Agonist

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

Disease	Relation	SNOMED_ID	DOID
Pulmonary emphysema	indication	87433001
Non-allergic asthma	indication	266361008	DOID:9360
Severe chronic obstructive pulmonary disease	indication	313299006
Allergic asthma	indication	389145006	DOID:9415
Adjunct Therapy to Achieve Long-term Asthma Control	indication
Exercise-Induced Bronchospasm Prevention	indication
COPD Associated with Chronic Bronchitis	indication
Bronchospasm Prevention with COPD	indication
Mycosis	contraindication	3218000	DOID:1564
Ocular hypertension	contraindication	4210003	DOID:9282
Asthenia	contraindication	13791008
Measles	contraindication	14189004	DOID:8622
Disease caused by parasite	contraindication	17322007
Glaucoma	contraindication	23986001	DOID:1686
Acute tuberculosis	contraindication	25629007
Immunosuppression	contraindication	38013005
Hypertensive disorder	contraindication	38341003	DOID:10763
Varicella	contraindication	38907003	DOID:8659
Hypokalemia	contraindication	43339004
Conduction disorder of the heart	contraindication	44808001
Osteoporosis	contraindication	64859006	DOID:11476
Diabetes mellitus	contraindication	73211009	DOID:9351
Hypopituitarism	contraindication	74728003	DOID:9406
Thyrotoxicosis	contraindication	90739004	DOID:7997
Bilateral cataracts	contraindication	95722004
Prolonged QT interval	contraindication	111975006
Seizure disorder	contraindication	128613002
Ophthalmic herpes simplex	contraindication	186542001
Disease of liver	contraindication	235856003	DOID:409
Exacerbation of asthma	contraindication	281239006
Osteopenia	contraindication	312894000
Chronic myocardial ischemia	contraindication	413844008	DOID:3393
Congenital long QT syndrome	contraindication	442917000
Uncontrolled Bacterial Infections	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	9.23	acidic
pKa2	12.47	acidic
pKa3	8.49	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
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	10166247	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	10166247	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	10166247	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	7759328	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	7759328	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	7759328	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8143239	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8143239	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8143239	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8575137	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8575137	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8575137	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	10166247	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	10166247	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	10166247	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	7759328	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	7759328	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	7759328	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8143239	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8143239	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8143239	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8575137	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8575137	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8575137	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.4MG/INH;0.012MG/INH	DUAKLIR PRESSAIR	COVIS	N210595	March 29, 2019	RX	POWDER, METERED	INHALATION	RE46417	Feb. 10, 2025	MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.4MG/INH;0.012MG/INH	DUAKLIR PRESSAIR	COVIS	N210595	March 29, 2019	RX	POWDER, METERED	INHALATION	10085974	March 13, 2029	MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.4MG/INH;0.012MG/INH	DUAKLIR PRESSAIR	COVIS	N210595	March 29, 2019	RX	POWDER, METERED	INHALATION	11000517	March 13, 2029	MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH	BEVESPI AEROSPHERE	ASTRAZENECA	N208294	April 25, 2016	RX	AEROSOL, METERED	INHALATION	10716753	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH	BEVESPI AEROSPHERE	ASTRAZENECA	N208294	April 25, 2016	RX	AEROSOL, METERED	INHALATION	8324266	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH	BEVESPI AEROSPHERE	ASTRAZENECA	N208294	April 25, 2016	RX	AEROSOL, METERED	INHALATION	8703806	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH	BEVESPI AEROSPHERE	ASTRAZENECA	N208294	April 25, 2016	RX	AEROSOL, METERED	INHALATION	8808713	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH	BEVESPI AEROSPHERE	ASTRAZENECA	N208294	April 25, 2016	RX	AEROSOL, METERED	INHALATION	9415009	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH	BEVESPI AEROSPHERE	ASTRAZENECA	N208294	April 25, 2016	RX	AEROSOL, METERED	INHALATION	9463161	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	10716753	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	8324266	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	8703806	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	8808713	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	9415009	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	9463161	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH	BEVESPI AEROSPHERE	ASTRAZENECA	N208294	April 25, 2016	RX	AEROSOL, METERED	INHALATION	8815258	March 17, 2031	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	8815258	March 17, 2031	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.4MG/INH;0.012MG/INH	DUAKLIR PRESSAIR	COVIS	N210595	March 29, 2019	RX	POWDER, METERED	INHALATION	March 29, 2022	NEW COMBINATION
0.005MG/INH;0.05MG/INH	DULERA	ORGANON LLC	N022518	Aug. 12, 2019	RX	AEROSOL, METERED	INHALATION	Aug. 12, 2022	NEW STRENGTH
0.005MG/INH;0.05MG/INH	DULERA	ORGANON LLC	N022518	Aug. 12, 2019	RX	AEROSOL, METERED	INHALATION	Feb. 12, 2023	PEDIATRIC EXCLUSIVITY
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	July 23, 2023	NEW COMBINATION

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Beta-2 adrenergic receptor	GPCR	P07550	ADRB2_HUMAN	AGONIST	Kd	8.60	CHEMBL	CHEMBL
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN		Ki	4.89	CHEMBL
Beta-1 adrenergic receptor	GPCR	P08588	ADRB1_HUMAN		Ki	6.50	CHEMBL
Beta-3 adrenergic receptor	GPCR	P13945	ADRB3_HUMAN		EC50	7.60	CHEMBL
Heat shock protein HSP 90-alpha	Cytosolic other	P07900	HS90A_HUMAN		IC50	8.52	WOMBAT-PK
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	5.79	CHEMBL
Beta-2 adrenergic receptor	GPCR		ADRB2_CAVPO		EC50	8.80	CHEMBL

External reference:

ID	Source
4021266	VUID
N0000148706	NUI
D01373	KEGG_DRUG
183814-30-4	SECONDARY_CAS_RN
4021266	VANDF
4021267	VANDF
4026240	VANDF
C0060657	UMLSCUI
CHEBI:5147	CHEBI
CHEMBL1256786	ChEMBL_ID
CHEMBL3989798	ChEMBL_ID
DB00983	DRUGBANK_ID
D000068759	MESH_DESCRIPTOR_UI
3083544	PUBCHEM_CID
3465	IUPHAR_LIGAND_ID
4935	INN_ID
5ZZ84GCW8B	UNII
236216	RXNORM
15056	MMSL
347879	MMSL
d04572	MMSL
005421	NDDF
005422	NDDF
016698	NDDF
129490002	SNOMEDCT_US
386171009	SNOMEDCT_US
414289007	SNOMEDCT_US
447213002	SNOMEDCT_US
CHEMBL2133469	ChEMBL_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Dulera	HUMAN PRESCRIPTION DRUG LABEL	2	0085-4610	AEROSOL	5 ug	RESPIRATORY (INHALATION)	NDA	29 sections
Dulera	HUMAN PRESCRIPTION DRUG LABEL	2	0085-7206	AEROSOL	5 ug	RESPIRATORY (INHALATION)	NDA	29 sections
Formoterol fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0093-4061	SOLUTION	20 ug	RESPIRATORY (INHALATION)	ANDA	28 sections
Formoterol fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0093-4061	SOLUTION	20 ug	RESPIRATORY (INHALATION)	ANDA	28 sections
SYMBICORT	HUMAN PRESCRIPTION DRUG LABEL	2	0186-0370	AEROSOL	4.50 ug	RESPIRATORY (INHALATION)	NDA	28 sections
SYMBICORT	HUMAN PRESCRIPTION DRUG LABEL	2	0186-0370	AEROSOL	4.50 ug	RESPIRATORY (INHALATION)	NDA	28 sections
SYMBICORT	HUMAN PRESCRIPTION DRUG LABEL	2	0186-0372	AEROSOL	4.50 ug	RESPIRATORY (INHALATION)	NDA	28 sections
SYMBICORT	HUMAN PRESCRIPTION DRUG LABEL	2	0186-0372	AEROSOL	4.50 ug	RESPIRATORY (INHALATION)	NDA	28 sections
DUAKLIR PRESSAIR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-0900	POWDER, METERED	12 ug	RESPIRATORY (INHALATION)	NDA	27 sections
BEVESPI AEROSPHERE	HUMAN PRESCRIPTION DRUG LABEL	2	0310-4600	AEROSOL, METERED	4.80 ug	RESPIRATORY (INHALATION)	NDA	29 sections
BEVESPI AEROSPHERE	HUMAN PRESCRIPTION DRUG LABEL	2	0310-4600	AEROSOL, METERED	4.80 ug	RESPIRATORY (INHALATION)	NDA	29 sections
BREZTRI	HUMAN PRESCRIPTION DRUG LABEL	3	0310-4616	AEROSOL, METERED	4.80 ug	RESPIRATORY (INHALATION)	NDA	28 sections
Budesonide and Formoterol Fumarate Dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0310-7370	AEROSOL	4.50 ug	RESPIRATORY (INHALATION)	NDA authorized generic	28 sections
Budesonide and Formoterol Fumarate Dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0310-7372	AEROSOL	4.50 ug	RESPIRATORY (INHALATION)	NDA authorized generic	28 sections
FORMOTEROL FUMARATE	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1631	SOLUTION	20 ug	RESPIRATORY (INHALATION)	NDA authorized generic	28 sections
BREYNA	HUMAN PRESCRIPTION DRUG LABEL	2	0378-7502	AEROSOL, METERED	4.50 ug	RESPIRATORY (INHALATION)	ANDA	29 sections
BREYNA	HUMAN PRESCRIPTION DRUG LABEL	2	0378-7503	AEROSOL, METERED	4.50 ug	RESPIRATORY (INHALATION)	ANDA	29 sections
Perforomist	HUMAN PRESCRIPTION DRUG LABEL	1	49502-605	SOLUTION	20 ug	RESPIRATORY (INHALATION)	NDA	28 sections
Dulera	HUMAN PRESCRIPTION DRUG LABEL	2	50090-1916	AEROSOL	5 ug	RESPIRATORY (INHALATION)	NDA	29 sections
Budesonide and Formoterol Fumarate Dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	53002-2666	AEROSOL	4.50 ug	RESPIRATORY (INHALATION)	NDA authorized generic	29 sections
Budesonide and Formoterol Fumarate Dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	53002-2667	AEROSOL	4.50 ug	RESPIRATORY (INHALATION)	NDA authorized generic	29 sections
Formoterol Fumarate	Human Prescription Drug Label	1	62332-655	SOLUTION	20 ug	RESPIRATORY (INHALATION)	ANDA	26 sections
Formoterol Fumarate	Human Prescription Drug Label	1	62332-655	SOLUTION	20 ug	RESPIRATORY (INHALATION)	ANDA	26 sections
Formoterol fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8813	SOLUTION	20 ug	RESPIRATORY (INHALATION)	ANDA	28 sections
Formoterol fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8813	SOLUTION	20 ug	RESPIRATORY (INHALATION)	ANDA	28 sections
Formoterol fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8814	SOLUTION	20 ug	RESPIRATORY (INHALATION)	ANDA	28 sections
Formoterol fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8814	SOLUTION	20 ug	RESPIRATORY (INHALATION)	ANDA	28 sections
SYMBICORT	HUMAN PRESCRIPTION DRUG LABEL	2	70518-2696	AEROSOL	4.50 ug	RESPIRATORY (INHALATION)	NDA	28 sections
Budesonide and Formoterol Fumarate Dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	70518-3107	AEROSOL	4.50 ug	RESPIRATORY (INHALATION)	NDA authorized generic	28 sections
Budesonide and Formoterol Fumarate Dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	70518-3107	AEROSOL	4.50 ug	RESPIRATORY (INHALATION)	NDA authorized generic	28 sections