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	802.57	13.41	610	33118	126951	63328343
Product quality issue	611.66	13.41	323	33405	35542	63419752
Dyspnoea	538.76	13.41	1120	32608	660193	62795101
Obstructive airways disorder	403.35	13.41	204	33524	20495	63434799
Wheezing	387.47	13.41	355	33373	95240	63360054
Cough	272.52	13.41	526	33202	292217	63163077
Polycystic ovaries	228.75	13.41	87	33641	4384	63450910
Sleep apnoea syndrome	199.65	13.41	147	33581	28986	63426308
Gastrooesophageal reflux disease	198.16	13.41	249	33479	95390	63359904
Nasal polyps	187.06	13.41	82	33646	5957	63449337
Chest discomfort	165.17	13.41	245	33483	109724	63345570
Chronic obstructive pulmonary disease	162.45	13.41	183	33545	62503	63392791
No adverse event	152.57	13.41	146	33582	41259	63414035
Sensitisation	152.28	13.41	60	33668	3326	63451968
Ejection fraction	145.74	13.41	53	33675	2353	63452941
Rhinitis allergic	140.84	13.41	84	33644	11643	63443651
Blood test abnormal	137.69	13.41	92	33636	15537	63439757
Full blood count abnormal	130.63	13.41	119	33609	31598	63423696
Emphysema	117.62	13.41	73	33655	10865	63444429
Sputum increased	115.61	13.41	45	33683	2414	63452880
Off label use	113.50	13.41	115	33613	674347	62780947
Salpingo-oophorectomy unilateral	112.20	13.41	34	33694	847	63454447
Sleep disorder due to a general medical condition	110.39	13.41	73	33655	12115	63443179
Asthmatic crisis	110.04	13.41	40	33688	1773	63453521
Sinusitis fungal	105.95	13.41	39	33689	1792	63453502
Productive cough	105.31	13.41	148	33580	63060	63392234
Product dose omission issue	105.30	13.41	318	33410	233995	63221299
Candida infection	100.70	13.41	98	33630	28253	63427041
Respiratory symptom	98.99	13.41	44	33684	3303	63451991
Embolism venous	95.00	13.41	42	33686	3112	63452182
Hyper IgE syndrome	92.94	13.41	26	33702	484	63454810
Skin candida	91.17	13.41	34	33694	1621	63453673
Systemic lupus erythematosus	90.65	13.41	5	33723	208913	63246381
Urinary tract discomfort	90.65	13.41	27	33701	633	63454661
Bronchopulmonary aspergillosis allergic	87.67	13.41	36	33692	2222	63453072
Hypothyroidism	85.03	13.41	109	33619	42523	63412771
Joint swelling	83.21	13.41	35	33693	327631	63127663
Eczema	83.14	13.41	94	33634	32197	63423097
Alveolar osteitis	82.37	13.41	27	33701	874	63454420
Bronchiectasis	79.37	13.41	67	33661	16075	63439219
Eosinophilic granulomatosis with polyangiitis	78.54	13.41	33	33695	2159	63453135
Treatment failure	77.23	13.41	8	33720	199035	63256259
Burning sensation	77.02	13.41	118	33610	54289	63401005
Alopecia	76.63	13.41	42	33686	337494	63117800
Arthropathy	76.05	13.41	16	33712	234776	63220518
Pulmonary mass	74.48	13.41	75	33653	22521	63432773
Tunnel vision	74.44	13.41	27	33701	1189	63454105
Dyspnoea exertional	71.96	13.41	121	33607	60181	63395113
Restrictive pulmonary disease	71.00	13.41	29	33699	1766	63453528
Drug intolerance	70.65	13.41	38	33690	308623	63146671
Animal scratch	70.40	13.41	27	33701	1391	63453903
Diastolic dysfunction	66.58	13.41	42	33686	6429	63448865
Mycobacterium avium complex infection	64.72	13.41	32	33696	3056	63452238
Sputum discoloured	64.69	13.41	60	33668	16287	63439007
Ejection fraction abnormal	64.38	13.41	27	33701	1758	63453536
Toxicity to various agents	63.40	13.41	26	33702	247224	63208070
Pneumonia	63.31	13.41	437	33291	456330	62998964
Female genital tract fistula	62.99	13.41	43	33685	7516	63447778
Ear congestion	62.04	13.41	30	33698	2729	63452565
Bronchospasm	61.86	13.41	60	33668	17220	63438074
Nephrectomy	61.83	13.41	25	33703	1483	63453811
Bladder pain	60.83	13.41	28	33700	2280	63453014
Abdominal discomfort	58.14	13.41	51	33677	320834	63134460
Hepatic enzyme increased	57.44	13.41	18	33710	202310	63252984
Diverticulum	57.37	13.41	49	33679	11942	63443352
Pain	55.99	13.41	204	33524	740424	62714870
Product use issue	55.23	13.41	24	33704	220496	63234798
Eosinophil count increased	55.04	13.41	46	33682	10882	63444412
Pericarditis	54.52	13.41	4	33724	131575	63323719
Carpal tunnel syndrome	54.26	13.41	61	33667	20756	63434538
Hiatus hernia	52.44	13.41	61	33667	21533	63433761
Infusion related reaction	52.22	13.41	33	33695	245488	63209806
Swelling	50.80	13.41	43	33685	275335	63179959
Wound complication	50.69	13.41	29	33699	3718	63451576
Chronic sinusitis	50.55	13.41	47	33681	12796	63442498
Polymyalgia rheumatica	50.37	13.41	29	33699	3762	63451532
Dysphonia	49.59	13.41	90	33638	47524	63407770
Fatigue	49.47	13.41	274	33454	887754	62567540
Rheumatoid arthritis	48.85	13.41	38	33690	253781	63201513
Oedema peripheral	48.24	13.41	214	33514	189297	63265997
Sinus pain	47.77	13.41	27	33701	3383	63451911
Limb injury	47.46	13.41	63	33665	25414	63429880
Renal disorder	47.33	13.41	72	33656	32902	63422392
Rales	47.17	13.41	45	33683	12652	63442642
Glossodynia	47.17	13.41	18	33710	178858	63276436
Cardiac disorder	46.64	13.41	91	33637	50725	63404569
Respiratory tract infection	46.53	13.41	81	33647	41402	63413892
White blood cell count decreased	46.01	13.41	9	33719	139095	63316199
Hysterectomy	45.82	13.41	39	33689	9460	63445834
Tricuspid valve incompetence	45.40	13.41	47	33681	14574	63440720
Drug ineffective	44.75	13.41	349	33379	1044416	62410878
Paranasal sinus discomfort	44.02	13.41	28	33700	4348	63450946
Eosinophilic bronchitis	43.77	13.41	15	33713	558	63454736
Neurosensory hypoacusis	43.17	13.41	12	33716	218	63455076
Arthralgia	42.93	13.41	157	33571	569553	62885741
Therapeutic product effect decreased	42.41	13.41	25	33703	193162	63262132
Product container issue	41.85	13.41	20	33708	1773	63453521
Musculoskeletal stiffness	41.81	13.41	23	33705	184595	63270699
Pulmonary function test decreased	41.57	13.41	26	33702	3921	63451373
Iron deficiency anaemia	41.29	13.41	52	33676	19917	63435377
Wound secretion	40.24	13.41	27	33701	4587	63450707
CFTR gene mutation	40.13	13.41	10	33718	116	63455178
Heart rate increased	39.53	13.41	125	33603	94113	63361181
Sputum culture positive	38.26	13.41	20	33708	2147	63453147
Discomfort	37.68	13.41	21	33707	167353	63287941
Hypoaesthesia oral	37.10	13.41	40	33688	12993	63442301
Vital capacity decreased	36.49	13.41	18	33710	1710	63453584
Hypoacusis	36.46	13.41	54	33674	24097	63431197
Facial nerve disorder	36.20	13.41	13	33715	556	63454738
Reversible airways obstruction	35.40	13.41	18	33710	1824	63453470
Impaired healing	35.27	13.41	6	33722	102536	63352758
Dyslipidaemia	34.93	13.41	30	33698	7363	63447931
Oropharyngeal pain	34.86	13.41	120	33608	94367	63360927
Febrile neutropenia	34.57	13.41	10	33718	118439	63336855
Incorrect dose administered	34.34	13.41	89	33639	59879	63395415
Neutropenic sepsis	34.30	13.41	43	33685	16395	63438899
Intentional product use issue	33.49	13.41	13	33715	127879	63327415
Drug hypersensitivity	32.62	13.41	73	33655	310614	63144680
Bronchitis	32.46	13.41	142	33586	124793	63330501
Psoriatic arthropathy	32.28	13.41	5	33723	91515	63363779
Drug dependence	31.71	13.41	51	33677	24432	63430862
Sinus disorder	31.61	13.41	51	33677	24502	63430792
Feeling jittery	31.11	13.41	37	33691	13366	63441928
Rhinitis	30.81	13.41	34	33694	11332	63443962
Product taste abnormal	30.68	13.41	17	33711	2050	63453244
Lipohypertrophy	30.66	13.41	12	33716	653	63454641
Pulmonary embolism	30.60	13.41	133	33595	116551	63338743
Infection	30.10	13.41	47	33681	229126	63226168
Hypertension	30.01	13.41	252	33476	279051	63176243
Panic attack	29.59	13.41	47	33681	22284	63433010
Myopathy	29.52	13.41	33	33695	11158	63444136
Pulmonary congestion	29.30	13.41	41	33687	17377	63437917
Bronchial secretion retention	28.53	13.41	18	33710	2755	63452539
Coronary artery disease	28.52	13.41	57	33671	32320	63422974
Nervous system disorder	28.39	13.41	42	33686	18724	63436570
Diarrhoea	28.20	13.41	244	33484	715122	62740172
Transient ischaemic attack	28.06	13.41	62	33666	37691	63417603
Angioplasty	27.91	13.41	14	33714	1378	63453916
Peak expiratory flow rate decreased	27.77	13.41	11	33717	618	63454676
Peripheral vascular disorder	27.53	13.41	24	33704	6011	63449283
Increased bronchial secretion	27.52	13.41	15	33713	1751	63453543
Peripheral swelling	27.49	13.41	63	33665	265879	63189415
Congenital naevus	27.17	13.41	8	33720	180	63455114
Eosinophil count decreased	27.11	13.41	16	33712	2174	63453120
Skin lesion	26.96	13.41	54	33674	30667	63424627
Osteoporosis	25.84	13.41	78	33650	57260	63398034
Hypomagnesaemia	25.80	13.41	51	33677	28686	63426608
Drug abuse	25.48	13.41	4	33724	72514	63382780
Bronchitis chronic	25.47	13.41	20	33708	4333	63450961
Blood electrolytes abnormal	25.26	13.41	12	33716	1049	63454245
Myocardial infarction	24.78	13.41	112	33616	99781	63355513
Mobility decreased	24.77	13.41	17	33711	121142	63334152
Breast neoplasm	24.66	13.41	13	33715	1419	63453875
Disease progression	24.08	13.41	18	33710	122740	63332554
Increased upper airway secretion	23.95	13.41	18	33710	3654	63451640
Throat tightness	23.35	13.41	45	33683	24842	63430452
Infective exacerbation of chronic obstructive airways disease	23.33	13.41	12	33716	1245	63454049
Lung neoplasm malignant	22.88	13.41	39	33689	19594	63435700
Stomatitis	22.81	13.41	24	33704	138701	63316593
Fungal infection	22.43	13.41	56	33672	36818	63418476
Blood iron decreased	22.34	13.41	33	33695	14688	63440606
Condition aggravated	22.32	13.41	124	33604	402093	63053201
Rash	22.20	13.41	191	33537	560680	62894614
Female reproductive neoplasm	21.97	13.41	5	33723	38	63455256
Disease recurrence	21.93	13.41	47	33681	27983	63427311
Restless legs syndrome	21.84	13.41	37	33691	18494	63436800
Breath sounds abnormal	21.78	13.41	28	33700	10945	63444349
Movement disorder	21.36	13.41	40	33688	21621	63433673
Swollen tongue	21.33	13.41	53	33675	34747	63420547
Gastrointestinal disorder	21.25	13.41	23	33705	131216	63324078
Pharyngeal oedema	21.17	13.41	31	33697	13690	63441604
Loss of personal independence in daily activities	21.15	13.41	105	33623	97185	63358109
Forced expiratory volume decreased	21.15	13.41	19	33709	4949	63450345
Vascular graft infection	21.02	13.41	5	33723	47	63455247
Circumstance or information capable of leading to medication error	20.97	13.41	17	33711	3853	63451441
Depression	20.93	13.41	177	33551	196315	63258979
Choking	20.86	13.41	26	33702	9853	63445441
Hypokinesia	20.81	13.41	31	33697	13905	63441389
Pancreatitis relapsing	20.78	13.41	10	33718	900	63454394
Irritable bowel syndrome	20.56	13.41	9	33719	82403	63372891
Lip pruritus	20.40	13.41	10	33718	937	63454357
Intentional overdose	20.32	13.41	7	33721	74145	63381149
Polyp	20.31	13.41	21	33707	6500	63448794
Underdose	20.30	13.41	45	33683	27411	63427883
Respiratory tract congestion	20.22	13.41	35	33693	17797	63437497
Anaphylactic reaction	20.20	13.41	79	33649	66021	63389273
Hypotension	19.89	13.41	76	33652	272528	63182766
Feeling cold	19.78	13.41	41	33687	23847	63431447
Throat irritation	19.65	13.41	54	33674	37593	63417701
Bordetella test positive	19.62	13.41	3	33725	0	63455294
Carnitine deficiency	19.34	13.41	6	33722	162	63455132
Therapy partial responder	19.30	13.41	26	33702	10632	63444662
COVID-19	19.24	13.41	19	33709	113084	63342210
Haemoptysis	18.94	13.41	45	33683	28681	63426613
Malignant neoplasm progression	18.91	13.41	10	33718	82111	63373183
Device malfunction	18.90	13.41	34	33694	17823	63437471
Dysphagia	18.83	13.41	95	33633	88490	63366804
Allergic sinusitis	18.80	13.41	10	33718	1112	63454182
Middle insomnia	18.70	13.41	28	33700	12615	63442679
Foreign body aspiration	18.08	13.41	6	33722	202	63455092
Sinusitis	18.07	13.41	192	33536	226461	63228833
Macrocytosis	18.06	13.41	13	33715	2472	63452822
Abscess	17.98	13.41	32	33696	16636	63438658
Upper-airway cough syndrome	17.91	13.41	26	33702	11392	63443902
Kyphosis	17.80	13.41	13	33715	2527	63452767
Blood urine present	17.65	13.41	30	33698	15039	63440255
Spirometry abnormal	17.21	13.41	6	33722	235	63455059
Deep vein thrombosis	17.20	13.41	89	33639	83711	63371583
Oligohydramnios	17.18	13.41	19	33709	6347	63448947
Tubulointerstitial nephritis and uveitis syndrome	17.12	13.41	6	33722	239	63455055
Neutrophilia	17.10	13.41	16	33712	4390	63450904
Platelet count decreased	17.03	13.41	22	33706	116100	63339194
Device ineffective	16.90	13.41	6	33722	248	63455046
Neutropenia	16.85	13.41	43	33685	174962	63280332
Palpitations	16.79	13.41	110	33618	112660	63342634
Psoriasis	16.73	13.41	13	33715	86944	63368350
Urinary retention	16.35	13.41	44	33684	30257	63425037
Oedema mouth	16.12	13.41	12	33716	2401	63452893
Liver injury	16.09	13.41	6	33722	60514	63394780
Mouth ulceration	15.93	13.41	46	33682	32938	63422356
Therapeutic product effect incomplete	15.69	13.41	117	33611	124939	63330355
Syncope	15.40	13.41	111	33617	117274	63338020
Crepitations	15.15	13.41	20	33708	8020	63447274
Lower respiratory tract infection	15.05	13.41	121	33607	132186	63323108
Product use in unapproved indication	15.03	13.41	47	33681	179033	63276261
Maternal exposure during pregnancy	15	13.41	63	33665	219999	63235295
Haemorrhage	14.81	13.41	68	33660	60954	63394340
Acute kidney injury	14.70	13.41	81	33647	263334	63191960
Thrombocytopenia	14.66	13.41	37	33691	151120	63304174
Coma	14.58	13.41	8	33720	64356	63390938
Cardiac failure	14.54	13.41	89	33639	89053	63366241
Eosinophilia	14.30	13.41	35	33693	22721	63432573
Presbyacusis	14.30	13.41	12	33716	2853	63452441
Joint injury	14.05	13.41	41	33687	29531	63425763
Therapy non-responder	13.79	13.41	12	33716	75889	63379405
Inflammation	13.78	13.41	14	33714	82259	63373035
Vascular graft occlusion	13.66	13.41	5	33723	226	63455068
Dysuria	13.45	13.41	44	33684	33694	63421600

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	483.98	14.27	288	17258	42368	34897017
Product quality issue	405.58	14.27	189	17357	16846	34922539
Dyspnoea	298.62	14.27	610	16936	376172	34563213
Nasal obstruction	170.20	14.27	44	17502	636	34938749
Chronic obstructive pulmonary disease	164.97	14.27	160	17386	48758	34890627
Wheezing	155.97	14.27	144	17402	41258	34898127
Asthma-chronic obstructive pulmonary disease overlap syndrome	150.92	14.27	46	17500	1241	34938144
No adverse event	145.60	14.27	108	17438	22819	34916566
Sinus pain	125.12	14.27	35	17511	692	34938693
Cough	109.51	14.27	236	17310	149904	34789481
Eosinophilic granulomatosis with polyangiitis	94.14	14.27	36	17510	1951	34937434
Emphysema	91.62	14.27	58	17488	9467	34929918
Pulmonary function test decreased	87.67	14.27	45	17501	4930	34934455
Mycobacterium avium complex infection	85.97	14.27	36	17510	2475	34936910
Throat irritation	78.93	14.27	55	17491	10530	34928855
Obstructive airways disorder	74.57	14.27	62	17484	15432	34923953
Vocal cord dysfunction	71.95	14.27	17	17529	165	34939220
Bronchiectasis	70.92	14.27	50	17496	9751	34929634
Chest discomfort	70.58	14.27	110	17436	54420	34884965
Bronchial hyperreactivity	70.48	14.27	28	17518	1681	34937704
Eosinophil count	69.20	14.27	16	17530	140	34939245
Sputum discoloured	66.35	14.27	44	17502	7768	34931617
Product dose omission issue	63.10	14.27	166	17380	119545	34819840
Hepatic vein dilatation	62.89	14.27	16	17530	216	34939169
Osteopenia	58.12	14.27	34	17512	4815	34934570
Respiratory disorder	57.45	14.27	59	17487	19205	34920180
Lung consolidation	56.71	14.27	36	17510	5900	34933485
Suffocation feeling	56.06	14.27	18	17528	578	34938807
Liver palpable	54.38	14.27	15	17531	281	34939104
Nasal congestion	53.71	14.27	62	17484	22995	34916390
Nasal polyps	51.04	14.27	25	17521	2478	34936907
Full blood count abnormal	44.83	14.27	51	17495	18617	34920768
Panic reaction	43.41	14.27	19	17527	1456	34937929
Sleep disorder due to a general medical condition	43.35	14.27	29	17517	5192	34934193
Breath sounds abnormal	42.72	14.27	32	17514	6849	34932536
Toxicity to various agents	42.35	14.27	24	17522	200338	34739047
Pulmonary mass	41.42	14.27	41	17505	12771	34926614
Sputum increased	40.49	14.27	21	17525	2349	34937036
Inferior vena cava dilatation	40.46	14.27	15	17531	745	34938640
Product prescribing error	39.50	14.27	53	17493	22874	34916511
Respiratory tract haemorrhage	39.46	14.27	17	17529	1253	34938132
Hangover	39.13	14.27	16	17530	1035	34938350
Ventricular enlargement	38.67	14.27	14	17532	650	34938735
Dyspnoea at rest	38.54	14.27	24	17522	3804	34935581
Atrial enlargement	38.50	14.27	14	17532	658	34938727
Pulmonary function test abnormal	35.83	14.27	20	17526	2590	34936795
Bronchial obstruction	35.54	14.27	17	17529	1599	34937786
Chest pain	34.20	14.27	140	17406	126622	34812763
Stridor	30.98	14.27	18	17528	2516	34936869
Forced expiratory volume decreased	29.54	14.27	19	17527	3184	34936201
Bronchospasm	28.66	14.27	31	17515	10700	34928685
Therapeutic product effect incomplete	27.50	14.27	71	17475	50470	34888915
Therapeutic drug monitoring analysis incorrectly performed	27.18	14.27	9	17537	319	34939066
Drug abuse	27.17	14.27	8	17538	99088	34840297
Nasal turbinate hypertrophy	26.83	14.27	7	17539	105	34939280
Toxic neuropathy	26.02	14.27	10	17536	549	34938836
Weaning failure	25.66	14.27	8	17538	233	34939152
Bronchial disorder	25.61	14.27	13	17533	1390	34937995
Fungal oesophagitis	25.30	14.27	9	17537	397	34938988
Neutropenia	25.11	14.27	25	17521	156753	34782632
Platelet count decreased	24.33	14.27	15	17531	119702	34819683
Oedema mouth	23.68	14.27	12	17534	1279	34938106
Foreign body aspiration	23.62	14.27	7	17539	171	34939214
Product container issue	23.58	14.27	10	17536	709	34938676
Heart rate irregular	23.43	14.27	34	17512	15773	34923612
Oedema peripheral	23.14	14.27	120	17426	119692	34819693
Oedema	22.60	14.27	62	17484	45679	34893706
Pneumonia	22.45	14.27	279	17267	362348	34577037
Underdose	22.44	14.27	31	17515	13749	34925636
Eosinophilia	22.29	14.27	44	17502	26178	34913207
Urinary hesitation	21.92	14.27	15	17531	2787	34936598
Cockroach allergy	21.70	14.27	5	17541	43	34939342
Off label use	21.66	14.27	123	17423	419401	34519984
Cardiac failure chronic	21.46	14.27	23	17523	7856	34931529
Adrenal cortex necrosis	20.85	14.27	4	17542	12	34939373
Palpitations	20.55	14.27	55	17491	39931	34899454
Rales	20.41	14.27	25	17521	9858	34929527
Death	20.38	14.27	117	17429	397932	34541453
Disease progression	20.01	14.27	15	17531	108062	34831323
Product use in unapproved indication	19.66	14.27	18	17528	117481	34821904
Spontaneous haemorrhage	19.58	14.27	7	17539	313	34939072
Pulmonary congestion	19.52	14.27	29	17517	13736	34925649
Necrotising ulcerative gingivostomatitis	19.48	14.27	5	17541	70	34939315
Orthostatic intolerance	19.15	14.27	9	17537	814	34938571
Product taste abnormal	18.91	14.27	10	17536	1164	34938221
Paranasal sinus mucosal hypertrophy	18.69	14.27	5	17541	83	34939302
Dysphonia	18.40	14.27	38	17508	23345	34916040
Dust allergy	18.32	14.27	9	17537	897	34938488
Diarrhoea	18.18	14.27	118	17428	389794	34549591
Laryngeal cryptococcosis	17.72	14.27	3	17543	3	34939382
Circumstance or information capable of leading to medication error	17.52	14.27	11	17535	1768	34937617
Complicated appendicitis	16.82	14.27	4	17542	40	34939345
Productive cough	16.48	14.27	49	17497	37764	34901621
Sleep apnoea syndrome	15.96	14.27	33	17513	20288	34919097
Tooth injury	15.91	14.27	9	17537	1196	34938189
Nocturnal dyspnoea	15.68	14.27	7	17539	562	34938823
Status asthmaticus	15.62	14.27	6	17540	329	34939056
Rebound effect	15.53	14.27	13	17533	3261	34936124
Paradoxical drug reaction	15.27	14.27	13	17533	3338	34936047
Aortic dissection	15.27	14.27	12	17534	2756	34936629
Mycotic allergy	15.24	14.27	7	17539	601	34938784
Aphonia	15.20	14.27	13	17533	3360	34936025
Bronchitis	15.19	14.27	51	17495	41912	34897473
Eosinophil count increased	15.04	14.27	20	17526	8552	34930833
Coronary artery stenosis	14.71	14.27	21	17525	9595	34929790
Infective exacerbation of chronic obstructive airways disease	14.69	14.27	10	17536	1841	34937544
Syncope	14.58	14.27	87	17459	91364	34848021
Tendon pain	14.43	14.27	12	17534	2983	34936402
Arthritis allergic	14.43	14.27	3	17543	15	34939370
Dyspnoea exertional	14.27	14.27	51	17495	43228	34896157

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	794.32	12.42	603	38819	134492	79570474
Dyspnoea	560.50	12.42	1273	38149	855752	78849214
Wheezing	387.89	12.42	376	39046	116288	79588678
Obstructive airways disorder	350.04	12.42	209	39213	31250	79673716
Cough	317.39	12.42	613	38809	366176	79338790
Product quality issue	238.43	12.42	169	39253	33771	79671195
Chronic obstructive pulmonary disease	216.27	12.42	238	39184	85181	79619785
Nasal polyps	212.56	12.42	93	39329	7234	79697732
Polycystic ovaries	211.29	12.42	77	39345	3702	79701264
Sleep apnoea syndrome	190.28	12.42	152	39270	36326	79668640
Emphysema	180.50	12.42	108	39314	16192	79688774
Gastrooesophageal reflux disease	178.12	12.42	238	39184	104008	79600958
Eosinophilic granulomatosis with polyangiitis	166.08	12.42	64	39358	3596	79701370
Chest discomfort	163.25	12.42	265	39157	137779	79567187
Full blood count abnormal	154.51	12.42	141	39281	40333	79664633
Sputum increased	135.26	12.42	59	39363	4554	79700412
Sensitisation	122.63	12.42	50	39372	3261	79701705
Ejection fraction	114.94	12.42	43	39379	2226	79702740
Rhinitis allergic	114.74	12.42	73	39349	12196	79692770
Blood test abnormal	110.27	12.42	82	39340	17628	79687338
Sputum discoloured	109.96	12.42	89	39333	21654	79683312
Salpingo-oophorectomy unilateral	107.68	12.42	32	39390	802	79704164
Asthma-chronic obstructive pulmonary disease overlap syndrome	106.98	12.42	45	39377	3176	79701790
Sinus pain	103.70	12.42	46	39376	3696	79701270
Bronchiectasis	103.53	12.42	87	39335	22299	79682667
Sleep disorder due to a general medical condition	102.33	12.42	72	39350	14205	79690761
Productive cough	100.88	12.42	167	39255	88164	79616802
Pulmonary function test decreased	96.14	12.42	55	39367	7582	79697384
Nasal obstruction	95.19	12.42	37	39385	2127	79702839
Toxicity to various agents	94.76	12.42	45	39377	421495	79283471
Asthmatic crisis	94.32	12.42	36	39386	1970	79702996
Off label use	92.74	12.42	194	39228	907021	78797945
Hyper IgE syndrome	91.89	12.42	26	39396	545	79704421
Sinusitis fungal	91.87	12.42	37	39385	2337	79702629
Respiratory symptom	86.96	12.42	44	39378	4747	79700219
Skin candida	85.88	12.42	34	39388	2053	79702913
Embolism venous	80.08	12.42	40	39382	4199	79700767
Bronchospasm	74.81	12.42	76	39346	24783	79680183
Dyspnoea exertional	70.66	12.42	142	39280	86931	79618035
Hypothyroidism	67.95	12.42	105	39317	52287	79652679
Candida infection	67.90	12.42	89	39333	38125	79666841
Eczema	67.82	12.42	92	39330	40726	79664240
Completed suicide	67.38	12.42	19	39403	245748	79459218
Female genital tract fistula	67.20	12.42	40	39382	5935	79699031
Restrictive pulmonary disease	65.86	12.42	30	39392	2565	79702401
Eosinophil count	65.54	12.42	15	39407	127	79704839
Chronic sinusitis	65.18	12.42	53	39369	12973	79691993
Urinary tract discomfort	64.40	12.42	21	39401	720	79704246
Bronchopulmonary aspergillosis allergic	64.14	12.42	31	39391	3030	79701936
Joint swelling	63.01	12.42	32	39390	288614	79416352
Oedema peripheral	61.98	12.42	268	39154	252020	79452946
Pulmonary mass	61.77	12.42	74	39348	28960	79676006
Alveolar osteitis	61.69	12.42	21	39401	824	79704142
Breath sounds abnormal	61.59	12.42	56	39366	15928	79689038
Nephrectomy	58.61	12.42	26	39396	2089	79702877
Ejection fraction abnormal	58.14	12.42	27	39395	2413	79702553
Hepatic vein dilatation	57.23	12.42	15	39407	233	79704733
Bronchial hyperreactivity	55.41	12.42	28	39394	3012	79701954
Pneumonia	55.33	12.42	533	38889	659713	79045253
Diastolic dysfunction	54.12	12.42	44	39378	10767	79694199
Rales	52.77	12.42	57	39365	19944	79685022
Arthropathy	51.78	12.42	12	39410	177099	79527867
Liver palpable	51.65	12.42	15	39407	346	79704620
Hysterectomy	50.54	12.42	34	39388	6238	79698728
Animal scratch	50.32	12.42	21	39401	1453	79703513
Drug abuse	49.64	12.42	10	39412	162681	79542285
Tunnel vision	48.94	12.42	21	39401	1557	79703409
Contraindicated product administered	47.41	12.42	10	39412	157528	79547438
Mycobacterium avium complex infection	47.11	12.42	29	39393	4571	79700395
Treatment failure	47.05	12.42	13	39409	170473	79534493
Vital capacity decreased	46.10	12.42	21	39401	1795	79703171
Diverticulum	45.66	12.42	46	39376	14850	79690116
Burning sensation	45.63	12.42	94	39328	58538	79646428
Ear congestion	44.92	12.42	24	39398	2895	79702071
Febrile neutropenia	44.18	12.42	30	39392	230969	79473997
Neurosensory hypoacusis	44.03	12.42	12	39410	218	79704748
Bladder pain	43.99	12.42	22	39400	2315	79702651
Vocal cord dysfunction	43.79	12.42	15	39407	600	79704366
Respiratory disorder	43.59	12.42	79	39343	44777	79660189
Carpal tunnel syndrome	43.56	12.42	51	39371	19477	79685489
Product use issue	43.23	12.42	25	39397	209797	79495169
Intentional product use issue	43.11	12.42	11	39411	152101	79552865
Eosinophil count increased	42.09	12.42	47	39375	17058	79687908
Forced expiratory volume decreased	41.66	12.42	33	39389	7781	79697185
Tricuspid valve incompetence	41.53	12.42	50	39372	19662	79685304
Hiatus hernia	40.95	12.42	54	39368	23258	79681708
Throat irritation	40.92	12.42	73	39349	40873	79664093
Pain	40.91	12.42	194	39228	703608	79001358
Cardiac disorder	40.52	12.42	96	39326	65661	79639305
Bronchial obstruction	40.48	12.42	22	39400	2746	79702220
Pericarditis	40.03	12.42	3	39419	104233	79600733
Eosinophilia	39.24	12.42	76	39346	45269	79659697
Alopecia	39.21	12.42	34	39388	231321	79473645
Inferior vena cava dilatation	38.69	12.42	15	39407	856	79704110
Suffocation feeling	37.80	12.42	18	39404	1702	79703264
Lung consolidation	37.75	12.42	33	39389	8914	79696052
Ventricular enlargement	37.54	12.42	14	39408	718	79704248
Musculoskeletal stiffness	37.28	12.42	20	39402	174988	79529978
Dysphonia	37.20	12.42	85	39337	56787	79648179
Respiratory tract haemorrhage	36.80	12.42	18	39404	1805	79703161
CFTR gene mutation	36.72	12.42	9	39413	105	79704861
Limb injury	36.64	12.42	58	39364	29470	79675496
Disease progression	36.53	12.42	23	39399	184339	79520627
Systemic lupus erythematosus	35.82	12.42	8	39414	121141	79583825
Osteoporosis	35.53	12.42	81	39341	54031	79650935
Infusion related reaction	35.32	12.42	37	39385	230200	79474766
White blood cell count decreased	35.28	12.42	25	39397	188263	79516703
Platelet count decreased	34.98	12.42	27	39395	194637	79510329
Pulmonary function test abnormal	34.68	12.42	23	39399	4121	79700845
Feeling jittery	34.58	12.42	37	39385	12804	79692162
Therapeutic product effect incomplete	34.38	12.42	150	39272	141495	79563471
Neutropenia	34.13	12.42	56	39366	287654	79417312
Facial nerve disorder	34.10	12.42	13	39409	709	79704257
Atrial enlargement	32.74	12.42	14	39408	1029	79703937
Pulmonary congestion	31.94	12.42	52	39370	27048	79677918
Bronchitis	31.43	12.42	138	39284	130506	79574460
Rheumatoid arthritis	31.42	12.42	34	39388	208436	79496530
Nasal congestion	31.25	12.42	96	39326	76456	79628510
Reversible airways obstruction	31.00	12.42	17	39405	2159	79702807
Dyspnoea at rest	30.95	12.42	27	39395	7275	79697691
Breast neoplasm	30.88	12.42	13	39409	919	79704047
Paranasal sinus discomfort	30.84	12.42	22	39400	4434	79700532
Polymyalgia rheumatica	30.48	12.42	22	39400	4515	79700451
Bronchial secretion retention	30.11	12.42	21	39401	4083	79700883
Product container issue	29.87	12.42	14	39408	1277	79703689
Oropharyngeal pain	29.80	12.42	120	39302	109233	79595733
Neutropenic sepsis	29.31	12.42	50	39372	27014	79677952
Sputum culture positive	29.28	12.42	20	39402	3761	79701205
Increased bronchial secretion	29.14	12.42	19	39403	3308	79701658
Stridor	29.01	12.42	23	39399	5430	79699536
Bronchial disorder	28.87	12.42	17	39405	2472	79702494
Respiratory tract infection	28.83	12.42	70	39352	48619	79656347
Peripheral vascular disorder	28.74	12.42	27	39395	8003	79696963
Renal disorder	28.72	12.42	64	39358	42041	79662925
Hangover	28.72	12.42	16	39406	2096	79702870
Diarrhoea	28.60	12.42	288	39134	880201	78824765
Wound complication	28.60	12.42	22	39400	4971	79699995
Lipohypertrophy	28.19	12.42	12	39410	872	79704094
Psoriatic arthropathy	27.91	12.42	3	39419	77996	79626970
Therapeutic product effect decreased	27.85	12.42	24	39398	163839	79541127
Angioplasty	27.78	12.42	15	39407	1848	79703118
Eosinophilic bronchitis	27.41	12.42	10	39412	482	79704484
Hepatic enzyme increased	27.27	12.42	30	39392	182580	79522386
Sinus disorder	26.33	12.42	43	39379	22421	79682545
Bronchitis chronic	26.22	12.42	20	39402	4462	79700504
Syncope	26.18	12.42	165	39257	179284	79525682
Loss of personal independence in daily activities	25.93	12.42	110	39312	102470	79602496
Sepsis	25.41	12.42	60	39362	269368	79435598
Chest pain	25.07	12.42	231	39191	282073	79422893
Sinusitis	25.03	12.42	174	39248	195327	79509639
Swollen tongue	24.98	12.42	61	39361	42509	79662457
Heart rate increased	24.96	12.42	122	39300	120602	79584364
Urinary hesitation	24.88	12.42	19	39403	4247	79700719
Drug intolerance	24.77	12.42	59	39363	264060	79440906
Peripheral swelling	24.67	12.42	61	39361	269556	79435410
Iron deficiency anaemia	24.66	12.42	45	39377	25627	79679339
COVID-19	24.55	12.42	25	39397	157649	79547317
Wound secretion	24.47	12.42	22	39400	6166	79698800
Infection	24.29	12.42	52	39370	241660	79463306
Peak expiratory flow rate decreased	24.22	12.42	10	39412	673	79704293
Product prescribing error	23.98	12.42	62	39360	44751	79660215
Panic attack	23.97	12.42	43	39379	24173	79680793
Pulmonary embolism	23.91	12.42	156	39266	171498	79533468
Hypoaesthesia oral	23.71	12.42	32	39390	14092	79690874
Dyslipidaemia	23.68	12.42	29	39393	11604	79693362
Skin lesion	23.54	12.42	59	39363	41785	79663181
Arthralgia	23.43	12.42	176	39246	571627	79133339
Foreign body aspiration	23.26	12.42	8	39414	324	79704642
Increased upper airway secretion	23.04	12.42	18	39404	4159	79700807
Lower respiratory tract infection	22.84	12.42	125	39297	129095	79575871
Cockroach allergy	22.44	12.42	6	39416	101	79704865
Nervous system disorder	22.01	12.42	44	39378	26812	79678154
Dust allergy	21.88	12.42	12	39410	1524	79703442
Product use in unapproved indication	21.86	12.42	58	39364	250301	79454665
Pharyngeal oedema	21.63	12.42	33	39389	16239	79688727
Transient ischaemic attack	21.43	12.42	66	39356	52629	79652337
Rhinitis	21.07	12.42	31	39391	14776	79690190
Oedema mouth	20.97	12.42	15	39407	3036	79701930
Spirometry abnormal	20.97	12.42	10	39412	949	79704017
Type 2 diabetes mellitus	20.91	12.42	69	39353	57053	79647913
Toxic neuropathy	20.76	12.42	10	39412	970	79703996
Fungal oesophagitis	20.68	12.42	10	39412	978	79703988
Hypertension	20.55	12.42	252	39170	330740	79374226
Therapeutic drug monitoring analysis incorrectly performed	20.48	12.42	9	39413	707	79704259
Impaired healing	20.20	12.42	9	39413	87646	79617320
Palpitations	20.09	12.42	119	39303	126491	79578475
Adrenal cortex necrosis	20.02	12.42	4	39418	16	79704950
Infective exacerbation of chronic obstructive airways disease	19.85	12.42	14	39408	2770	79702196
Swelling	19.85	12.42	49	39373	216662	79488304
Bordetella test positive	19.84	12.42	3	39419	0	79704966
Blood electrolytes abnormal	19.32	12.42	12	39410	1922	79703044
Panic reaction	19.27	12.42	17	39405	4648	79700318
Respiratory tract congestion	19.20	12.42	35	39387	19919	79685047
Restless legs syndrome	19.02	12.42	35	39387	20057	79684909
Stomatitis	18.89	12.42	27	39395	146730	79558236
Fatigue	18.87	12.42	335	39087	929392	78775574
Encephalopathy	18.85	12.42	5	39417	67392	79637574
Crepitations	18.84	12.42	24	39398	9993	79694973
Allergic sinusitis	18.83	12.42	9	39413	858	79704108
Intentional overdose	18.64	12.42	15	39407	105945	79599021
Thrombocytopenia	18.53	12.42	68	39354	265191	79439775
Lip pruritus	18.40	12.42	9	39413	903	79704063
Abdominal discomfort	18.36	12.42	63	39359	250664	79454302
Mobility decreased	18.31	12.42	20	39402	122155	79582811
Haemoptysis	18.18	12.42	65	39357	55934	79649032
Paranasal sinus mucosal hypertrophy	18.18	12.42	5	39417	94	79704872
Rebound effect	18.03	12.42	20	39402	7206	79697760
Coma	18.02	12.42	14	39408	100635	79604331
Laryngeal cryptococcosis	17.76	12.42	3	39419	3	79704963
Pancreatitis relapsing	17.65	12.42	9	39413	987	79703979
Lung neoplasm malignant	17.58	12.42	41	39381	27751	79677215
Product taste abnormal	17.55	12.42	12	39410	2259	79702707
Depression	17.55	12.42	174	39248	216616	79488350
Drug hypersensitivity	17.53	12.42	82	39340	298834	79406132
Throat tightness	17.46	12.42	41	39381	27866	79677100
Status asthmaticus	17.33	12.42	9	39413	1025	79703941
Weaning failure	17.31	12.42	8	39414	707	79704259
Discomfort	17.29	12.42	22	39400	125595	79579371
Macrocytosis	17.22	12.42	13	39409	2857	79702109
Urinary retention	16.93	12.42	64	39358	56566	79648400
Orthostatic intolerance	16.88	12.42	11	39411	1913	79703053
Death	16.84	12.42	189	39233	566325	79138641
Carnitine deficiency	16.73	12.42	6	39416	275	79704691
Fungal infection	16.70	12.42	52	39370	41696	79663270
Middle insomnia	16.50	12.42	29	39393	16040	79688926
Gastrointestinal disorder	16.21	12.42	22	39400	122183	79582783
Hypotension	15.96	12.42	140	39282	440177	79264789
Upper-airway cough syndrome	15.95	12.42	24	39398	11669	79693297
Drug ineffective for unapproved indication	15.94	12.42	3	39419	51235	79653731
Presbyacusis	15.85	12.42	12	39410	2648	79702318
Kyphosis	15.73	12.42	12	39410	2679	79702287
Tubulointerstitial nephritis and uveitis syndrome	15.71	12.42	6	39416	329	79704637
Hypomagnesaemia	15.70	12.42	55	39367	46856	79658110
Circumstance or information capable of leading to medication error	15.54	12.42	14	39408	3934	79701032
Essential hypertension	15.53	12.42	17	39405	6036	79698930
Pollakiuria	15.41	12.42	47	39375	37270	79667696
Cardiac failure chronic	15.40	12.42	23	39399	11112	79693854
Psoriasis	15.37	12.42	13	39409	89574	79615392
Choking	15.33	12.42	24	39398	12077	79692889
Aortic dissection	14.87	12.42	14	39408	4161	79700805
Coronary artery disease	14.86	12.42	68	39354	65406	79639560
Blood iron decreased	14.76	12.42	27	39395	15407	79689559
Red blood cell count decreased	14.75	12.42	5	39417	57508	79647458
Sensitivity to weather change	14.69	12.42	19	39403	8028	79696938
Mouth ulceration	14.61	12.42	47	39375	38347	79666619
Hypoacusis	14.40	12.42	40	39382	30110	79674856
Product dose omission issue	14.30	12.42	186	39236	247351	79457615
Heart rate irregular	14.29	12.42	42	39380	32637	79672329
Depressed level of consciousness	14.29	12.42	16	39406	96636	79608330
Nasal turbinate hypertrophy	14.26	12.42	7	39415	708	79704258
Arthritis allergic	14.16	12.42	3	39419	17	79704949
Nasal inflammation	14.15	12.42	7	39415	720	79704246
Bone marrow failure	13.90	12.42	4	39418	51103	79653863
Osteopenia	13.76	12.42	29	39393	18335	79686631
Pyrexia	13.59	12.42	245	39177	678464	79026502
Dysphagia	13.50	12.42	105	39317	122031	79582935
Anaphylactic reaction	13.47	12.42	79	39343	83664	79621302
Coronary artery stenosis	13.43	12.42	23	39399	12461	79692505
Peak expiratory flow rate abnormal	13.39	12.42	4	39418	102	79704864
Spontaneous haemorrhage	13.37	12.42	7	39415	810	79704156
Glossodynia	13.31	12.42	19	39403	103318	79601648
Eosinophil count decreased	13.28	12.42	12	39410	3384	79701582
Pancytopenia	13.28	12.42	40	39382	165705	79539261
Hypoventilation	13.10	12.42	17	39405	7207	79697759
Hypokinesia	13.03	12.42	29	39393	19031	79685935
Arthritis	13.02	12.42	23	39399	114857	79590109
Aspartate aminotransferase increased	12.96	12.42	31	39391	138610	79566356
Rubber sensitivity	12.95	12.42	9	39413	1740	79703226
Granulomatosis with polyangiitis	12.95	12.42	11	39411	2859	79702107
Bradycardia	12.92	12.42	30	39392	135527	79569439
Incorrect dose administered	12.78	12.42	73	39349	76557	79628409
Drug ineffective	12.66	12.42	423	38999	1080490	78624476
Face and mouth X-ray abnormal	12.66	12.42	3	39419	30	79704936
Leukopenia	12.60	12.42	24	39398	116489	79588477
Sedation	12.48	12.42	5	39417	51890	79653076

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)
0.16MG/INH;0.0048MG/INH	SYMBICORT AEROSPHERE	ASTRAZENECA	N216579	April 28, 2023	RX	AEROSOL, METERED	INHALATION	10716753	May 28, 2030	MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH	SYMBICORT AEROSPHERE	ASTRAZENECA	N216579	April 28, 2023	RX	AEROSOL, METERED	INHALATION	9415009	May 28, 2030	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
0.005MG/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
C0771469	UMLSCUI
CHEBI:5147	CHEBI
CHEMBL1256786	ChEMBL_ID
CHEMBL3989798	ChEMBL_ID
DB00983	DRUGBANK_ID
D000068759	MESH_DESCRIPTOR_UI
3410	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
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
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
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	0378-7502	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
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
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	50090-6327	AEROSOL	4.50 ug	RESPIRATORY (INHALATION)	NDA authorized generic	29 sections
Budesonide and Formoterol Fumarate Dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	50090-6382	AEROSOL	4.50 ug	RESPIRATORY (INHALATION)	NDA authorized generic	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