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

Stem definition	Drug id	CAS RN
humanized origin	5061	196078-29-2

Description:

Molecule	Description
Synonyms: mepolizumab nucala SB 240563 SB-240563	Mepolizumab is an interleukin-5 antagonist (IgG1 kappa). IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Mepolizumab binds to IL-5 with a dissociation constant of 100 pM, inhibiting the bioactivity of IL-5 by blocking its binding to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

mepolizumab
nucala
SB 240563
SB-240563

Mepolizumab is an interleukin-5 antagonist (IgG1 kappa). IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Mepolizumab binds to IL-5 with a dissociation constant of 100 pM, inhibiting the bioactivity of IL-5 by blocking its binding to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
3.60	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company
Dec. 2, 2015	EMA	GlaxoSmithKline Trading Services
Nov. 4, 2015	FDA	GLAXOSMITHKLINE LLC
March 28, 2016	PMDA	GlaxoSmithKline K.K.

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
Wheezing	2481.60	21.70	1136	32023	94459	63361404
Sleep disorder due to a general medical condition	1661.31	21.70	493	32666	11695	63444168
Full blood count abnormal	1418.47	21.70	556	32603	31161	63424702
Obstructive airways disorder	1412.26	21.70	495	32664	20204	63435659
Therapeutic product effect incomplete	1398.05	21.70	847	32312	124209	63331654
Dyspnoea	1134.09	21.70	1543	31616	659770	62796093
Loss of personal independence in daily activities	1091.34	21.70	661	32498	96629	63359234
Cough	732.27	21.70	829	32330	291914	63163949
Productive cough	658.07	21.70	410	32749	62798	63393065
Sputum discoloured	556.68	21.70	236	32923	16111	63439752
Nasal polyps	444.40	21.70	153	33006	5886	63449977
Chest discomfort	435.54	21.70	400	32759	109569	63346294
Eosinophilia	402.69	21.70	209	32950	22547	63433316
Upper-airway cough syndrome	392.52	21.70	166	32993	11252	63444611
Exposure via skin contact	383.29	21.70	78	33081	327	63455536
Eosinophil count increased	372.75	21.70	158	33001	10770	63445093
Bronchial secretion retention	308.20	21.70	96	33063	2677	63453186
Reversible airways obstruction	279.14	21.70	81	33078	1761	63454102
Asthmatic crisis	262.71	21.70	77	33082	1736	63454127
Asthma	257.69	21.70	325	32834	127236	63328627
Pulmonary mass	248.56	21.70	152	33007	22444	63433419
Nasal congestion	244.51	21.70	231	32928	65429	63390434
Dyspnoea exertional	235.78	21.70	218	32941	60084	63395779
Rhinitis allergic	234.44	21.70	117	33042	11610	63444253
Bronchiectasis	226.11	21.70	127	33032	16015	63439848
Product complaint	221.82	21.70	116	33043	12693	63443170
Respiratory tract infection	214.70	21.70	176	32983	41307	63414556
Vital capacity decreased	209.70	21.70	64	33095	1664	63454199
Asthma-chronic obstructive pulmonary disease overlap syndrome	198.59	21.70	64	33095	1997	63453866
Sputum culture positive	191.41	21.70	63	33096	2104	63453759
Breath sounds abnormal	186.09	21.70	98	33061	10875	63444988
Eosinophil count abnormal	184.76	21.70	46	33113	542	63455321
Diarrhoea	179.55	21.70	75	33084	715291	62740572
Total lung capacity increased	175.66	21.70	60	33099	2250	63453613
Pulmonary function test abnormal	164.85	21.70	54	33105	1776	63454087
Multiple allergies	157.29	21.70	95	33064	13707	63442156
Product dose omission issue	153.85	21.70	362	32797	233951	63221912
Blood test abnormal	151.37	21.70	97	33062	15532	63440331
Wrong technique in device usage process	149.74	21.70	60	33099	3538	63452325
Pneumonia	136.17	21.70	534	32625	456233	62999630
Ear pruritus	134.08	21.70	57	33102	3908	63451955
Bronchial obstruction	133.86	21.70	44	33115	1463	63454400
Respiratory symptom	126.21	21.70	52	33107	3295	63452568
Bronchial wall thickening	126.07	21.70	42	33117	1457	63454406
Total lung capacity decreased	125.26	21.70	46	33113	2137	63453726
Sarcoidosis	121.87	21.70	64	33095	7058	63448805
Bronchopulmonary aspergillosis allergic	120.09	21.70	45	33114	2213	63453650
Bacterial disease carrier	118.78	21.70	39	33120	1292	63454571
Middle insomnia	116.36	21.70	76	33083	12567	63443296
Rales	116.06	21.70	76	33083	12621	63443242
Chest X-ray abnormal	113.98	21.70	53	33106	4496	63451367
Sneezing	110.73	21.70	85	33074	18133	63437730
Off label use	110.51	21.70	114	33045	674348	62781515
Acute kidney injury	109.99	21.70	7	33152	263408	63192455
Rhinitis	106.26	21.70	69	33090	11297	63444566
Nausea	103.01	21.70	181	32978	854290	62601573
Lung opacity	102.03	21.70	44	33115	3124	63452739
Bronchospasm	101.49	21.70	79	33080	17201	63438662
Cardiac murmur	97.55	21.70	72	33087	14480	63441383
Prolonged expiration	97.34	21.70	32	33127	1064	63454799
Toxicity to various agents	96.38	21.70	9	33150	247241	63208622
Chronic obstructive pulmonary disease	94.89	21.70	139	33020	62547	63393316
Sputum purulent	93.59	21.70	31	33128	1056	63454807
Vocal cord dysfunction	91.12	21.70	26	33133	531	63455332
Gastrooesophageal reflux disease	90.85	21.70	172	32987	95467	63360396
Sinus disorder	88.67	21.70	85	33074	24468	63431395
Drug interaction	87.57	21.70	9	33150	229122	63226741
Factor V Leiden mutation	87.48	21.70	21	33138	210	63455653
Rhinorrhoea	87.33	21.70	137	33022	65440	63390423
Superinfection	86.57	21.70	37	33122	2570	63453293
Accidental exposure to product	84.41	21.70	87	33072	27318	63428545
Chronic sinusitis	80.42	21.70	61	33098	12782	63443081
Heart sounds	80.17	21.70	27	33132	969	63454894
Blood immunoglobulin E increased	78.68	21.70	39	33120	3810	63452053
Hospitalisation	78.32	21.70	151	33008	84930	63370933
Kyphosis	77.63	21.70	34	33125	2506	63453357
Dehydration	77.43	21.70	3	33156	173351	63282512
Alopecia	77.24	21.70	40	33119	337496	63118367
Contraindicated product administered	77.14	21.70	11	33148	217637	63238226
Asthma exercise induced	75.99	21.70	20	33139	298	63455565
Eosinophilic granulomatosis with polyangiitis	75.73	21.70	32	33127	2160	63453703
Broncholithiasis	75.54	21.70	19	33140	234	63455629
Vomiting	75.29	21.70	110	33049	559507	62896356
Lymph node calcification	75.14	21.70	20	33139	312	63455551
Blood lactic acid increased	73.65	21.70	46	33113	7040	63448823
Laryngeal stenosis	70.41	21.70	25	33134	1053	63454810
Decreased appetite	68.26	21.70	23	33136	251029	63204834
Lower respiratory tract infection	67.48	21.70	186	32973	132121	63323742
Neutropenia	66.52	21.70	7	33152	174998	63280865
Secretion discharge	65.56	21.70	53	33106	12178	63443685
Confusional state	65.42	21.70	21	33138	236359	63219504
Mycobacterium avium complex infection	65.24	21.70	32	33127	3056	63452807
Hypotension	64.30	21.70	31	33128	272573	63183290
Swelling	63.92	21.70	32	33127	275346	63180517
Abdominal discomfort	62.34	21.70	46	33113	320839	63135024
Increased bronchial secretion	61.74	21.70	26	33133	1740	63454123
Rheumatoid arthritis	59.65	21.70	29	33130	253790	63202073
Infusion related reaction	59.32	21.70	27	33132	245494	63210369
Pulmonary function test decreased	57.83	21.70	32	33127	3915	63451948
Hypomania	55.68	21.70	37	33122	6293	63449570
Respiration abnormal	55.23	21.70	37	33122	6380	63449483
Peak expiratory flow rate decreased	54.40	21.70	18	33141	611	63455252
Jaundice cholestatic	53.09	21.70	38	33121	7286	63448577
Social problem	53.09	21.70	19	33140	819	63455044
Sinus operation	52.26	21.70	26	33133	2560	63453303
Influenza	51.65	21.70	149	33010	108573	63347290
Pemphigus	51.39	21.70	16	33143	183710	63272153
Respiratory tract inflammation	51.10	21.70	17	33142	587	63455276
Sleep apnoea syndrome	50.57	21.70	69	33090	29064	63426799
Rash	49.19	21.70	141	33018	560730	62895133
Disease progression	49.07	21.70	4	33155	122754	63333109
Maternal exposure during pregnancy	48.94	21.70	27	33132	220035	63235828
Platelet count increased	48.80	21.70	53	33106	17658	63438205
Impaired quality of life	48.41	21.70	47	33112	13736	63442127
Scoliosis	48.36	21.70	37	33122	7851	63448012
Neurosensory hypoacusis	48.02	21.70	13	33146	217	63455646
Venous pressure jugular increased	47.86	21.70	16	33143	561	63455302
Lung disorder	47.20	21.70	102	33057	62159	63393704
Sputum retention	47.19	21.70	16	33143	586	63455277
Hyponatraemia	46.58	21.70	3	33156	111897	63343966
Nasopharyngitis	46.39	21.70	258	32901	253999	63201864
Joint swelling	46.36	21.70	62	33097	327604	63128259
Lung neoplasm malignant	45.99	21.70	54	33105	19579	63436284
Vasculitis	45.88	21.70	52	33107	18157	63437706
Glossodynia	45.87	21.70	18	33141	178858	63277005
Platelet count decreased	45.82	21.70	4	33155	116118	63339745
Sputum culture	45.76	21.70	13	33146	261	63455602
Mite allergy	45.75	21.70	16	33143	644	63455219
Lacrimation increased	45.46	21.70	55	33104	20576	63435287
Respiratory gas exchange disorder	45.15	21.70	14	33145	384	63455479
Arthropathy	45.13	21.70	34	33125	234758	63221105
White blood cell count decreased	44.92	21.70	9	33150	139095	63316768
Eye pruritus	44.82	21.70	52	33107	18619	63437244
Haemoglobin decreased	43.79	21.70	11	33148	145474	63310389
Depressive symptom	43.57	21.70	27	33132	4075	63451788
Pneumothorax spontaneous	42.10	21.70	16	33143	818	63455045
Emphysema	41.64	21.70	39	33120	10899	63444964
Hypercapnia	41.26	21.70	29	33130	5402	63450461
Abdominal pain	41.03	21.70	56	33103	293400	63162463
Schizophrenia	40.83	21.70	37	33122	9915	63445948
Dysphonia	40.76	21.70	82	33077	47532	63408331
Death	40.75	21.70	84	33075	374297	63081566
Upper respiratory tract infection	40.47	21.70	114	33045	81933	63373930
CFTR gene mutation	40.30	21.70	10	33149	116	63455747
Blood insulin abnormal	39.61	21.70	8	33151	32	63455831
Hand deformity	39.33	21.70	17	33142	159440	63296423
Throat clearing	39.29	21.70	21	33138	2398	63453465
Urinary tract infection	38.54	21.70	49	33110	264635	63191228
Rib fracture	38.44	21.70	53	33106	22544	63433319
Arthralgia	37.95	21.70	161	32998	569549	62886314
Stomatitis	37.17	21.70	13	33146	138712	63317151
Blister	36.84	21.70	11	33148	129803	63326060
Illness	36.75	21.70	80	33079	48979	63406884
Sinonasal obstruction	36.75	21.70	11	33148	267	63455596
Discomfort	36.53	21.70	21	33138	167353	63288510
Forced expiratory volume decreased	36.52	21.70	26	33133	4942	63450921
Oligoarthritis	36.37	21.70	13	33146	558	63455305
Systemic lupus erythematosus	35.55	21.70	34	33125	208884	63246979
Lipohypertrophy	34.44	21.70	13	33146	652	63455211
Inappropriate schedule of product administration	33.60	21.70	125	33034	103840	63352023
Appetite disorder	33.59	21.70	29	33130	7292	63448571
Synovitis	33.49	21.70	29	33130	186889	63268974
Nocturnal dyspnoea	32.98	21.70	15	33144	1209	63454654
Hypokalaemia	32.92	21.70	7	33152	103797	63352066
Blood glucose increased	32.73	21.70	3	33156	83753	63372110
Intentional product use issue	32.56	21.70	13	33146	127879	63327984
Fatigue	32.20	21.70	303	32856	887725	62568138
Nonspecific reaction	31.99	21.70	18	33141	2274	63453589
Somnolence	31.68	21.70	28	33131	178657	63277206
Haemoptysis	31.48	21.70	55	33104	28671	63427192
Tracheomalacia	31.26	21.70	9	33150	190	63455673
Blood calcium increased	31.19	21.70	31	33128	9319	63446544
Aspirin-exacerbated respiratory disease	30.70	21.70	13	33146	882	63454981
Crystal arthropathy	30.61	21.70	10	33149	326	63455537
Dust allergy	30.20	21.70	12	33147	692	63455171
Seizure	29.87	21.70	16	33143	132618	63323245
Sepsis	29.63	21.70	22	33137	153101	63302762
Aspiration	29.07	21.70	32	33127	10819	63445044
Rectal prolapse	28.84	21.70	16	33143	1967	63453896
Eye paraesthesia	28.58	21.70	8	33151	152	63455711
Forced expiratory volume abnormal	28.39	21.70	7	33152	79	63455784
Oedema	28.20	21.70	8	33151	97614	63358249
Angioplasty	28.14	21.70	14	33145	1378	63454485
Deep vein thrombosis	27.94	21.70	5	33154	83795	63372068
Treatment failure	27.78	21.70	38	33121	199005	63256858
Osteoporosis	27.62	21.70	79	33080	57259	63398604
Memory impairment	27.53	21.70	10	33149	104248	63351615
Constipation	27.50	21.70	47	33112	224896	63230967
Skin fragility	27.03	21.70	11	33148	675	63455188
Peripheral swelling	26.98	21.70	62	33097	265880	63189983
Pain	26.68	21.70	253	32906	740375	62715488
Sputum abnormal	26.28	21.70	11	33148	725	63455138
Atelectasis	26.01	21.70	43	33116	21440	63434423
FEV1/FVC ratio decreased	25.85	21.70	7	33152	117	63455746
Breast neoplasm	24.87	21.70	13	33146	1419	63454444
Treatment noncompliance	24.76	21.70	58	33101	37267	63418596
Blood pressure increased	24.72	21.70	157	33002	161905	63293958
Oropharyngeal pain	24.44	21.70	106	33053	94381	63361482
Seasonal allergy	24.12	21.70	41	33118	20909	63434954
Crepitations	23.81	21.70	25	33134	8015	63447848
Airway remodelling	23.63	21.70	6	33153	77	63455786
Cholelithiasis	23.61	21.70	63	33096	43862	63412001
Respiratory tract congestion	23.37	21.70	37	33122	17795	63438068
Irritable bowel syndrome	23.35	21.70	7	33152	82405	63373458
Anaemia	23.34	21.70	77	33082	293353	63162510
Adrenal insufficiency	23.24	21.70	37	33122	17878	63437985
Lung hyperinflation	23.19	21.70	12	33147	1283	63454580
Flail chest	23.14	21.70	6	33153	84	63455779
Therapeutic product effect decreased	23.03	21.70	41	33118	193146	63262717
Adenocarcinoma	22.99	21.70	16	33143	2934	63452929
Pericarditis	22.86	21.70	21	33138	131558	63324305
Coronavirus test positive	22.86	21.70	10	33149	735	63455128
Cardiac failure	22.79	21.70	9	33150	89133	63366730
Gastrointestinal disorder	22.74	21.70	21	33138	131218	63324645
Helicobacter infection	22.70	21.70	10	33149	92775	63363088
Lung perforation	22.64	21.70	6	33153	92	63455771
Linear IgA disease	21.91	21.70	12	33147	1439	63454424
Allergic sinusitis	21.84	21.70	11	33148	1111	63454752
Suicide attempt	21.75	21.70	3	33156	60915	63394948
Pruritus	21.71	21.70	106	33053	361347	63094516

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
Wheezing	1663.19	37.22	660	16667	40742	34898862
Therapeutic product effect incomplete	1421.09	37.22	625	16702	49916	34889688
Sleep disorder due to a general medical condition	1227.11	37.22	320	17007	4901	34934703
Full blood count abnormal	919.58	37.22	346	16981	18322	34921282
Loss of personal independence in daily activities	894.07	37.22	399	16928	32780	34906824
Obstructive airways disorder	813.40	37.22	301	17026	15193	34924411
Dyspnoea	597.86	37.22	824	16503	375958	34563646
Productive cough	511.48	37.22	285	17042	37528	34902076
Cough	405.91	37.22	432	16895	149708	34789896
Asthma	294.29	37.22	210	17117	42446	34897158
Eosinophil count increased	278.86	37.22	118	17209	8454	34931150
Chest discomfort	271.50	37.22	221	17106	54309	34885295
Nasal polyps	238.15	37.22	76	17251	2427	34937177
Sputum discoloured	222.78	37.22	98	17229	7714	34931890
Chronic sinusitis	179.58	37.22	60	17267	2219	34937385
Nasal congestion	171.58	37.22	119	17208	22938	34916666
Lower respiratory tract infection	167.42	37.22	133	17194	31504	34908100
Bronchiectasis	166.19	37.22	86	17241	9715	34929889
Exposure via skin contact	160.90	37.22	29	17298	55	34939549
Breath sounds abnormal	157.26	37.22	74	17253	6807	34932797
Bronchopulmonary aspergillosis allergic	157.14	37.22	44	17283	885	34938719
Respiratory disorder	154.16	37.22	104	17223	19160	34920444
Vital capacity decreased	147.01	37.22	35	17292	357	34939247
Dyspnoea exertional	140.72	37.22	138	17189	43141	34896463
Diarrhoea	138.32	37.22	16	17311	389896	34549708
Bronchial obstruction	137.14	37.22	45	17282	1571	34938033
Blood immunoglobulin E increased	131.63	37.22	49	17278	2497	34937107
Product dose omission issue	131.02	37.22	222	17105	119489	34820115
Acute kidney injury	123.27	37.22	7	17320	304981	34634623
Chronic obstructive pulmonary disease	123.12	37.22	136	17191	48782	34890822
Eosinophilic granulomatosis with polyangiitis	112.91	37.22	41	17286	1946	34937658
Blood test abnormal	111.97	37.22	59	17268	6912	34932692
Asthma-chronic obstructive pulmonary disease overlap syndrome	109.86	37.22	36	17291	1251	34938353
Mycobacterial infection	109.37	37.22	42	17285	2332	34937272
Rhinorrhoea	108.91	37.22	95	17232	25573	34914031
Forced expiratory volume decreased	103.81	37.22	44	17283	3159	34936445
Obesity	101.75	37.22	69	17258	12809	34926795
Obstruction	100.42	37.22	41	17286	2678	34936926
Hospitalisation	98.69	37.22	131	17196	56771	34882833
Pulmonary function test abnormal	98.59	37.22	40	17287	2570	34937034
Asthmatic crisis	90.42	37.22	25	17302	479	34939125
Bronchial hyperreactivity	88.74	37.22	33	17294	1676	34937928
Bronchiolitis	87.80	37.22	39	17288	3137	34936467
Sinusitis	87.14	37.22	105	17222	41297	34898307
Eosinophil count abnormal	87.10	37.22	22	17305	292	34939312
Nausea	83.87	37.22	32	17295	339876	34599728
Upper-airway cough syndrome	83.56	37.22	39	17288	3519	34936085
Eye disorder	82.37	37.22	54	17273	9474	34930130
Reversible airways obstruction	81.97	37.22	23	17304	466	34939138
Multiple allergies	77.04	37.22	35	17292	2968	34936636
Pulmonary function test decreased	76.76	37.22	41	17286	4934	34934670
Eosinophilia	76.70	37.22	79	17248	26143	34913461
Product complaint	75.63	37.22	43	17284	5847	34933757
Respiratory symptom	72.92	37.22	29	17298	1768	34937836
Off label use	72.76	37.22	61	17266	419463	34520141
Lung disorder	69.76	37.22	86	17241	34610	34904994
Parathyroid gland enlargement	69.30	37.22	16	17311	141	34939463
Restrictive pulmonary disease	68.99	37.22	25	17302	1179	34938425
Upper respiratory fungal infection	67.76	37.22	16	17311	157	34939447
Influenza	64.95	37.22	100	17227	49566	34890038
Rhinitis	64.95	37.22	40	17287	6298	34933306
Sepsis	63.71	37.22	5	17322	166556	34773048
Secretion discharge	62.38	37.22	38	17289	5867	34933737
Rhinitis perennial	62.27	37.22	17	17310	310	34939294
Neutropenia	62	37.22	4	17323	156774	34782830
Sinus congestion	61.61	37.22	37	17290	5568	34934036
Lung diffusion disorder	59.69	37.22	14	17313	133	34939471
Pulmonary mass	59.58	37.22	50	17277	12762	34926842
Nasal disorder	57.58	37.22	25	17302	1903	34937701
Forced expiratory volume	56.47	37.22	13	17314	113	34939491
Anaemia	55.76	37.22	23	17304	233312	34706292
Foetal malformation	55.29	37.22	13	17314	125	34939479
Polyp	54.28	37.22	30	17297	3862	34935742
Snoring	52.82	37.22	28	17299	3318	34936286
Ocular discomfort	52.00	37.22	24	17303	2110	34937494
Lung diffusion test decreased	51.51	37.22	17	17310	604	34939000
Inspiratory capacity abnormal	50.61	37.22	12	17315	120	34939484
Pneumonitis	49.69	37.22	72	17255	33806	34905798
Hypotension	49.57	37.22	24	17303	221625	34717979
Lymphadenopathy	48.48	37.22	65	17262	28398	34911206
Airway remodelling	48.20	37.22	13	17314	226	34939378
Oesophageal polyp	46.96	37.22	10	17317	58	34939546
Sputum purulent	46.92	37.22	15	17312	481	34939123
Wrong technique in device usage process	46.44	37.22	20	17307	1492	34938112
Lung hyperinflation	45.34	37.22	17	17310	883	34938721
Mycobacterium test positive	45.07	37.22	14	17313	408	34939196
Eosinophilic bronchitis	44.31	37.22	12	17315	212	34939392
Adjustment disorder	43.97	37.22	18	17309	1183	34938421
Upper respiratory tract infection	42.41	37.22	66	17261	32993	34906611
Dehydration	41.98	37.22	7	17320	129962	34809642
Seasonal allergy	41.69	37.22	31	17296	6644	34932960
Bronchial disorder	41.27	37.22	18	17309	1385	34938219
Fungal disease carrier	40.96	37.22	12	17315	285	34939319
Inguinal hernia repair	40.11	37.22	12	17315	307	34939297
Nephrectomy	39.94	37.22	15	17312	783	34938821
Gastrooesophageal reflux disease	39.60	37.22	69	17258	37855	34901749
Middle insomnia	38.97	37.22	30	17297	6772	34932832
Accidental exposure to product	38.19	37.22	39	17288	12763	34926841
Vomiting	38.09	37.22	40	17287	247581	34692023

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
Wheezing	3240.96	24.39	1459	40725	115205	79586999
Sleep disorder due to a general medical condition	2041.16	24.39	601	41583	13676	79688528
Full blood count abnormal	1806.57	24.39	711	41473	39763	79662441
Obstructive airways disorder	1783.21	24.39	658	41526	30801	79671403
Therapeutic product effect incomplete	1702.57	24.39	1010	41174	140635	79561569
Loss of personal independence in daily activities	1383.79	24.39	789	41395	101791	79600413
Dyspnoea	1240.11	24.39	1858	40326	855167	78847037
Productive cough	1054.45	24.39	628	41556	87703	79614501
Cough	1028.29	24.39	1109	41075	365680	79336524
Sputum discoloured	713.83	24.39	307	41877	21436	79680768
Chest discomfort	662.81	24.39	563	41621	137481	79564723
Nasal polyps	581.22	24.39	197	41987	7130	79695074
Eosinophil count increased	549.86	24.39	238	41946	16867	79685337
Upper-airway cough syndrome	450.22	24.39	185	41999	11508	79690696
Eosinophilia	393.86	24.39	264	41920	45081	79657123
Nasal congestion	360.29	24.39	309	41875	76243	79625961
Bronchiectasis	357.90	24.39	193	41991	22193	79680011
Dyspnoea exertional	337.54	24.39	315	41869	86758	79615446
Breath sounds abnormal	328.05	24.39	163	42021	15821	79686383
Asthma	325.89	24.39	379	41805	134716	79567488
Bronchial secretion retention	308.46	24.39	106	42078	3998	79698206
Vital capacity decreased	301.57	24.39	86	42098	1730	79700474
Reversible airways obstruction	290.53	24.39	87	42097	2089	79700115
Asthma-chronic obstructive pulmonary disease overlap syndrome	288.80	24.39	95	42089	3126	79699078
Asthmatic crisis	266.95	24.39	80	42104	1926	79700278
Rhinitis allergic	248.45	24.39	124	42060	12145	79690059
Diarrhoea	248.39	24.39	79	42105	880410	78821794
Pulmonary function test abnormal	242.92	24.39	89	42095	4055	79698149
Blood test abnormal	242.77	24.39	138	42046	17572	79684632
Bronchopulmonary aspergillosis allergic	241.53	24.39	82	42102	2979	79699225
Acute kidney injury	229.19	24.39	11	42173	519393	79182811
Multiple allergies	227.53	24.39	111	42073	10349	79691855
Pulmonary mass	225.88	24.39	158	42026	28876	79673328
Toxicity to various agents	203.48	24.39	4	42180	421536	79280668
Chronic obstructive pulmonary disease	201.40	24.39	237	41947	85182	79617022
Bronchial obstruction	198.36	24.39	69	42115	2699	79699505
Rhinorrhoea	194.34	24.39	220	41964	75854	79626350
Exposure via skin contact	194.11	24.39	43	42141	286	79701918
Chronic sinusitis	193.48	24.39	107	42077	12919	79689285
Drug interaction	185.66	24.39	8	42176	415175	79287029
Lower respiratory tract infection	179.48	24.39	277	41907	128943	79573261
Respiratory symptom	178.28	24.39	74	42110	4717	79697487
Total lung capacity increased	167.44	24.39	58	42126	2240	79699964
Blood immunoglobulin E increased	166.85	24.39	75	42109	5807	79696397
Respiratory tract infection	165.58	24.39	164	42020	48525	79653679
Product dose omission issue	164.10	24.39	387	41797	247150	79455054
Off label use	157.94	24.39	149	42035	907066	78795138
Eosinophil count abnormal	149.52	24.39	41	42143	710	79701494
Ear pruritus	144.53	24.39	61	42123	4054	79698150
Middle insomnia	140.49	24.39	94	42090	15975	79686229
Nausea	137.33	24.39	184	42000	957012	78745192
Sputum culture positive	135.98	24.39	57	42127	3724	79698480
Eosinophilic granulomatosis with polyangiitis	127.70	24.39	54	42130	3606	79698598
Sneezing	125.53	24.39	95	42089	19588	79682616
Gastrooesophageal reflux disease	122.23	24.39	207	41977	104039	79598165
Prolonged expiration	116.00	24.39	38	42146	1233	79700971
Lung opacity	115.81	24.39	56	42128	5118	79697086
Neutropenia	115.21	24.39	10	42174	287700	79414504
Bacterial disease carrier	112.56	24.39	39	42145	1507	79700697
Pneumonia	112.39	24.39	663	41521	659583	79042621
Influenza	110.05	24.39	224	41960	129382	79572822
Chest X-ray abnormal	109.56	24.39	62	42122	7821	79694383
Secretion discharge	105.88	24.39	77	42107	14945	79687259
Hypotension	104.85	24.39	51	42133	440266	79261938
Bronchospasm	104.11	24.39	94	42090	24765	79677439
Rales	102.76	24.39	85	42099	19916	79682288
Bronchial wall thickening	102.36	24.39	42	42142	2599	79699605
Total lung capacity decreased	101.81	24.39	43	42141	2862	79699342
Sarcoidosis	101.09	24.39	60	42124	8275	79693929
Dehydration	101.09	24.39	8	42176	248179	79454025
Obstruction	100.48	24.39	49	42135	4561	79697643
Sinus disorder	100.15	24.39	88	42096	22376	79679828
Mycobacterial infection	98.43	24.39	45	42139	3623	79698581
Respiratory disorder	98.34	24.39	120	42064	44736	79657468
Pulmonary function test decreased	97.94	24.39	57	42127	7580	79694624
Rhinitis	97.83	24.39	73	42111	14734	79687470
Death	97.20	24.39	94	42090	566420	79135784
Forced expiratory volume decreased	96.73	24.39	57	42127	7757	79694447
Vomiting	94.24	24.39	129	42055	665699	79036505
Cardiac murmur	91.36	24.39	72	42112	15752	79686452
Upper respiratory tract infection	90.07	24.39	168	42016	91000	79611204
Vasculitis	84.29	24.39	84	42100	25018	79677186
Lung disorder	84.05	24.39	152	42032	80405	79621799
Vocal cord dysfunction	83.88	24.39	25	42159	590	79701614
Bronchiolitis	83.81	24.39	42	42142	4146	79698058
Sepsis	81.49	24.39	21	42163	269407	79432797
Bronchial hyperreactivity	80.65	24.39	37	42147	3003	79699201
Heart sounds	80.63	24.39	27	42157	939	79701265
Lung diffusion disorder	80.11	24.39	19	42165	177	79702027
Sputum purulent	79.16	24.39	29	42155	1320	79700884
Kyphosis	78.52	24.39	35	42149	2656	79699548
Confusional state	78.48	24.39	35	42149	317962	79384242
Hospitalisation	77.75	24.39	161	42023	94075	79608129
Eye pruritus	76.88	24.39	73	42111	20497	79681707
Respiration abnormal	76.47	24.39	49	42135	7739	79694465
White blood cell count decreased	74.12	24.39	7	42177	188281	79513923
Decreased appetite	72.31	24.39	46	42138	342372	79359832
Broncholithiasis	71.16	24.39	18	42166	224	79701980
Nasopharyngitis	70.17	24.39	293	41891	253588	79448616
Laryngeal stenosis	69.87	24.39	25	42159	1063	79701141
Obesity	69.06	24.39	89	42095	35036	79667168
Emphysema	68.97	24.39	62	42122	16238	79685966
Increased bronchial secretion	68.45	24.39	34	42150	3293	79698911
Restrictive pulmonary disease	67.02	24.39	31	42153	2564	79699640
Illness	66.31	24.39	101	42083	46410	79655794
Haemoptysis	65.33	24.39	111	42073	55888	79646316
Product complaint	64.99	24.39	55	42129	13294	79688910
Seasonal allergy	64.72	24.39	60	42124	16346	79685858
Drug abuse	64.16	24.39	6	42178	162685	79539519
Superinfection	63.96	24.39	37	42147	4865	79697339
Urinary tract infection	62.00	24.39	34	42150	274478	79427726
Lymph node calcification	61.54	24.39	18	42166	397	79701807
Wrong technique in device usage process	59.56	24.39	33	42151	3995	79698209
Malignant neoplasm progression	59.46	24.39	3	42181	135987	79566217
Sinus operation	58.54	24.39	28	42156	2497	79699707
Dysphonia	57.65	24.39	106	42078	56766	79645438
Atelectasis	57.65	24.39	78	42106	32179	79670025
Parathyroid gland enlargement	56.52	24.39	14	42170	159	79702045
Nasal disorder	56.07	24.39	31	42153	3738	79698466
Rhinitis perennial	55.36	24.39	16	42168	338	79701866
Fungal disease carrier	55.27	24.39	16	42168	340	79701864
Seizure	54.67	24.39	16	42168	188818	79513386
Crepitations	54.45	24.39	44	42140	9973	79692231
Infusion related reaction	54.23	24.39	27	42157	230210	79471994
Airway remodelling	53.69	24.39	15	42169	279	79701925
Polyp	53.62	24.39	40	42144	8067	79694137
Anaemia	53.53	24.39	96	42088	444919	79257285
Cardiac failure	53.10	24.39	9	42175	154833	79547371
Haemoglobin decreased	52.38	24.39	26	42158	222093	79480111
Hypercapnia	52.32	24.39	41	42143	8894	79693310
Forced expiratory volume	52.12	24.39	12	42172	97	79702107
Scoliosis	49.75	24.39	37	42147	7427	79694777
Hypomania	49.40	24.39	37	42147	7507	79694697
Overdose	49.12	24.39	18	42166	184188	79518016
Blood lactic acid increased	49.10	24.39	46	42138	12698	79689506
Contraindicated product administered	48.14	24.39	12	42172	157526	79544678
Hyponatraemia	48.07	24.39	17	42167	177831	79524373
Gastrointestinal haemorrhage	47.64	24.39	10	42174	147709	79554495
Disease progression	47.52	24.39	19	42165	184343	79517861
Mycobacterium test positive	47.42	24.39	15	42169	434	79701770
Lacrimation increased	47.42	24.39	59	42125	22418	79679786
Lung hyperinflation	47.36	24.39	22	42162	1837	79700367
Cardiac arrest	47.29	24.39	16	42168	172080	79530124
Upper respiratory fungal infection	46.55	24.39	14	42170	341	79701863
Adverse drug reaction	46.27	24.39	106	42078	66286	79635918
Eosinophilic bronchitis	46.08	24.39	15	42169	477	79701727
Intentional product use issue	45.69	24.39	12	42172	152100	79550104
Polymyalgia rheumatica	45.67	24.39	29	42155	4508	79697696
Inspiratory capacity abnormal	45.41	24.39	11	42173	113	79702091
Sputum abnormal	45.25	24.39	19	42165	1246	79700958
Stomatitis	45.19	24.39	11	42173	146746	79555458
Respiratory gas exchange disorder	45.19	24.39	17	42167	834	79701370
Eye disorder	43.96	24.39	58	42126	23354	79678850
Neurosensory hypoacusis	43.22	24.39	12	42172	218	79701986
Rheumatoid arthritis	42.62	24.39	29	42155	208441	79493763
Sinus congestion	41.62	24.39	52	42132	19844	79682360
Respiratory tract inflammation	41.28	24.39	16	42168	852	79701352
Blood glucose increased	40.96	24.39	6	42178	114969	79587235
Sleep apnoea syndrome	40.82	24.39	71	42113	36407	79665797
Social problem	39.71	24.39	18	42166	1420	79700784
Asthenia	39.25	24.39	139	42045	511550	79190654
Impaired quality of life	39.09	24.39	43	42141	14343	79687861
Oesophageal polyp	39.06	24.39	9	42175	73	79702131
Inguinal hernia repair	38.94	24.39	12	42172	318	79701886
Coma	38.92	24.39	4	42180	100645	79601559
Alopecia	38.87	24.39	39	42145	231316	79470888
Oedema	38.75	24.39	8	42176	119572	79582632
Bronchial disorder	38.48	24.39	21	42163	2468	79699736
Jaundice cholestatic	38.32	24.39	38	42146	11246	79690958
Lung diffusion test decreased	38.10	24.39	17	42167	1293	79700911
Snoring	38.02	24.39	28	42156	5538	79696666
Lung neoplasm malignant	37.71	24.39	59	42125	27733	79674471
Nocturnal dyspnoea	37.60	24.39	18	42166	1608	79700596
Haemophilus infection	37.41	24.39	20	42164	2256	79699948
Fatigue	37.30	24.39	314	41870	929413	78772791
Sinusitis	36.77	24.39	202	41982	195299	79506905
Oropharyngeal pain	36.48	24.39	134	42050	109219	79592985
CFTR gene mutation	36.11	24.39	9	42175	105	79702099
Agitation	36.00	24.39	5	42179	99710	79602494
Mite allergy	35.89	24.39	16	42168	1214	79700990
Pneumonitis	35.79	24.39	91	42093	60769	79641435
Nonspecific reaction	35.41	24.39	20	42164	2512	79699692
Rash	35.10	24.39	172	42012	578186	79124018
Somnolence	35.02	24.39	45	42139	238936	79463268
Joint swelling	34.91	24.39	62	42122	288584	79413620
Sinonasal obstruction	34.69	24.39	11	42173	321	79701883
Venous pressure jugular increased	34.58	24.39	16	42168	1324	79700880
Depressed level of consciousness	34.53	24.39	5	42179	96647	79605557
Sputum retention	34.37	24.39	15	42169	1082	79701122
Peak expiratory flow rate decreased	33.94	24.39	13	42171	670	79701534
Abdominal discomfort	33.94	24.39	50	42134	250677	79451527
Malaise	33.90	24.39	402	41782	489467	79212737
Delirium	33.68	24.39	3	42181	84624	79617580
Cardio-respiratory arrest	33.67	24.39	8	42176	108502	79593702
Inappropriate schedule of product administration	33.62	24.39	150	42034	133478	79568726
Oligoarthritis	33.21	24.39	13	42171	711	79701493
Suicide attempt	32.84	24.39	3	42181	82929	79619275
Depressive symptom	32.37	24.39	27	42157	6396	79695808
Throat clearing	31.91	24.39	19	42165	2635	79699569
Appetite disorder	31.88	24.39	29	42155	7710	79694494
Abdominal pain	31.77	24.39	103	42081	389466	79312738
Intentional product misuse	31.60	24.39	6	42178	95159	79607045
Hyperventilation	31.37	24.39	29	42155	7870	79694334
Blister	31.30	24.39	12	42172	119464	79582740
Septic shock	31.08	24.39	13	42171	122788	79579416
Platelet count increased	31.00	24.39	48	42136	22358	79679846
Loss of consciousness	30.94	24.39	26	42158	167917	79534287
Rib fracture	30.76	24.39	54	42130	27893	79674311
Swelling	30.53	24.39	42	42142	216669	79485535
Pneumothorax spontaneous	30.33	24.39	15	42169	1439	79700765
Arthralgia	30.28	24.39	178	42006	571625	79130579
Vascular shunt	30.14	24.39	7	42177	59	79702145
Sputum culture	30.01	24.39	9	42175	217	79701987
Lung hernia	29.83	24.39	7	42177	62	79702142
Dyspnoea paroxysmal nocturnal	29.55	24.39	17	42167	2211	79699993
Nasal septum deviation	29.50	24.39	16	42168	1857	79700347
Hypokalaemia	29.48	24.39	20	42164	144020	79558184
Aspiration	29.04	24.39	44	42140	20114	79682090
Osteoporosis	28.84	24.39	78	42106	54034	79648170
Neuropathy peripheral	28.42	24.39	20	42164	141285	79560919
Renal impairment	28.37	24.39	25	42159	157758	79544446
Blood calcium increased	28.11	24.39	31	42153	10369	79691835
Lipohypertrophy	27.41	24.39	12	42172	872	79701332
Rectal prolapse	27.25	24.39	16	42168	2162	79700042
Schizophrenia	27.08	24.39	37	42147	15403	79686801
Angioplasty	26.83	24.39	15	42169	1848	79700356
Aspirin-exacerbated respiratory disease	26.82	24.39	13	42171	1194	79701010
Breast neoplasm	26.80	24.39	12	42172	920	79701284
Respiratory tract congestion	26.57	24.39	42	42142	19912	79682292
Memory impairment	26.44	24.39	13	42171	111721	79590483
Renal failure	26.30	24.39	41	42143	200927	79501277
Haematuria	25.94	24.39	3	42181	68833	79633371
Choking	25.91	24.39	32	42152	12069	79690135
Medication error	25.84	24.39	3	42181	68639	79633565
Ocular discomfort	25.22	24.39	21	42163	4962	79697242

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	R03DX09	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES Other systemic drugs for obstructive airway diseases
FDA MoA	N0000191871	Interleukin-5 Antagonists
FDA EPC	N0000191872	Interleukin-5 Antagonist

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

Disease	Relation	SNOMED_ID	DOID
Allergic granulomatosis angiitis	indication	82275008	DOID:3049
Asthma	indication	195967001	DOID:2841
Eosinophilic asthma	indication	367542003	DOID:9498

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Interleukin-5	Cytokine	P05113	IL5_HUMAN	ANTIBODY BINDING	Kd	10		DRUG LABEL	DRUG LABEL

External reference:

ID	Source
90Z2UF0E52	UNII
D04923	KEGG_DRUG
4035064	VANDF
C0969324	UMLSCUI
CHEMBL2108429	ChEMBL_ID
DB06612	DRUGBANK_ID
7876	INN_ID
C434107	MESH_SUPPLEMENTAL_RECORD_UI
7685	IUPHAR_LIGAND_ID
1720597	RXNORM
237129	MMSL
27021	MMSL
d07571	MMSL
016563	NDDF
716046009	SNOMEDCT_US
781308003	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Nucala	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0881	INJECTION, POWDER, FOR SOLUTION	100 mg	SUBCUTANEOUS	BLA	27 sections
Nucala	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0881	INJECTION, POWDER, FOR SOLUTION	100 mg	SUBCUTANEOUS	BLA	27 sections
Nucala	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0881	INJECTION, POWDER, FOR SOLUTION	100 mg	SUBCUTANEOUS	BLA	27 sections
Nucala	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0881	INJECTION, POWDER, FOR SOLUTION	100 mg	SUBCUTANEOUS	BLA	27 sections
Nucala	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0892	INJECTION, SOLUTION	100 mg	SUBCUTANEOUS	BLA	27 sections
Nucala	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0892	INJECTION, SOLUTION	100 mg	SUBCUTANEOUS	BLA	27 sections
Nucala	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0892	INJECTION, SOLUTION	100 mg	SUBCUTANEOUS	BLA	27 sections
Nucala	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0892	INJECTION, SOLUTION	100 mg	SUBCUTANEOUS	BLA	27 sections
Nucala	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0904	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	BLA	27 sections
Nucala	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0904	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	BLA	27 sections
Nucala	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0904	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	BLA	27 sections