All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

mepolizumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Drug dosage:

Dose	Unit	Route
3.60	mg	P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

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

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Wheezing	1924.46	25.39	1866	107475	236214	90282892
Full blood count abnormal	1209	25.39	674	108667	35923	90483183
Obstructive airways disorder	1127.06	25.39	573	108768	25296	90493810
Therapeutic product effect incomplete	1105.50	25.39	1263	108078	192633	90326473
Sleep disorder due to a general medical condition	968.61	25.39	628	108713	44110	90474996
Loss of personal independence in daily activities	710.56	25.39	848	108493	135257	90383849
Blepharospasm	628.65	25.39	527	108814	54918	90464188
Nasal polyps	627.30	25.39	292	109049	10588	90508518
Onychomadesis	601.13	25.39	475	108866	45523	90473583
Gastrooesophageal reflux disease	595.62	25.39	861	108480	165476	90353630
Dyspnoea	505.31	25.39	2248	107093	878707	89640399
Taste disorder	498.33	25.39	484	108857	61062	90458044
Nail disorder	458.62	25.39	454	108887	58613	90460493
Back injury	443.43	25.39	401	108940	46221	90472885
Breast cancer stage III	412.43	25.39	509	108832	83938	90435168
Sputum discoloured	411.32	25.39	274	109067	20117	90498989
Onychomycosis	408.64	25.39	348	108993	37028	90482078
Peripheral venous disease	406.91	25.39	504	108837	83417	90435689
Epilepsy	397.45	25.39	493	108848	81713	90437393
Productive cough	396.64	25.39	477	108864	76586	90442520
Upper-airway cough syndrome	388.99	25.39	237	109104	14898	90504208
Lung disorder	388.13	25.39	669	108672	149214	90369892
Product quality issue	382.34	25.39	475	108866	78850	90440256
Rhinitis allergic	371.39	25.39	239	109102	16546	90502560
Eosinophilia	371.31	25.39	294	109047	28239	90490867
Facet joint syndrome	345.59	25.39	505	108836	97884	90421222
Cough	327.80	25.39	1084	108257	367878	90151228
Acute kidney injury	326.72	25.39	14	109327	320373	90198733
Hypercholesterolaemia	323.16	25.39	496	108845	100396	90418710
Product complaint	320.54	25.39	201	109140	13299	90505807
Obesity	314.74	25.39	502	108839	105005	90414101
Bursitis	305.21	25.39	560	108781	131094	90388012
Asthma-chronic obstructive pulmonary disease overlap syndrome	302.76	25.39	138	109203	4761	90514345
Toxicity to various agents	298.82	25.39	11	109330	287835	90231271
Lip dry	289.73	25.39	472	108869	100483	90418623
Bronchial secretion retention	288.83	25.39	122	109219	3493	90515613
Drug interaction	285.48	25.39	11	109330	276442	90242664
Pulmonary function test abnormal	282.44	25.39	111	109230	2628	90516478
Total lung capacity increased	280.88	25.39	132	109209	4889	90514217
Bronchiectasis	275.44	25.39	223	109118	22107	90496999
Night sweats	267.83	25.39	523	108818	128243	90390863
Liver function test increased	267.27	25.39	414	108927	84441	90434665
Eosinophil count increased	264.34	25.39	176	109165	12905	90506201
Reversible airways obstruction	260.87	25.39	96	109245	1887	90517219
Wound infection	248.34	25.39	454	108887	105948	90413158
Neutropenia	242.79	25.39	6	109335	224898	90294208
Chest discomfort	233.80	25.39	516	108825	137849	90381257
Finger deformity	233.57	25.39	241	109100	32656	90486450
Wrong technique in device usage process	230.25	25.39	121	109220	5714	90513392
Joint range of motion decreased	228.23	25.39	505	108836	135138	90383968
C-reactive protein increased	222.64	25.39	598	108743	180791	90338315
Chest X-ray abnormal	222.46	25.39	113	109228	4969	90514137
Product dose omission issue	217.30	25.39	809	108532	290878	90228228
Hypotension	216.66	25.39	62	109279	325335	90193771
Neck pain	212.06	25.39	442	108899	113521	90405585
Adverse reaction	202.57	25.39	213	109128	29499	90489607
Thrombocytopenia	200.55	25.39	13	109328	208712	90310394
Pruritus	200.26	25.39	215	109126	541310	89977796
Ear pruritus	199.49	25.39	116	109225	6687	90512419
Breath sounds abnormal	199.00	25.39	158	109183	15228	90503878
Product label confusion	198.69	25.39	187	109154	22663	90496443
Sarcoidosis	197.53	25.39	136	109205	10537	90508569
Type 2 diabetes mellitus	197.26	25.39	616	108725	202628	90316478
Exposure via skin contact	194.81	25.39	135	109206	10570	90508536
Inflammation	191.84	25.39	561	108780	178031	90341075
Dehydration	184.21	25.39	13	109328	194434	90324672
Infusion site reaction	183.40	25.39	165	109176	18874	90500232
Urinary tract infection	182.84	25.39	70	109271	305562	90213544
Live birth	180.08	25.39	334	109007	78773	90440333
Lower respiratory tract infection	174.07	25.39	680	108661	249979	90269127
Folliculitis	173.66	25.39	592	108749	203761	90315345
Eosinophil count abnormal	172.02	25.39	57	109284	809	90518297
Osteoarthritis	170.71	25.39	572	108769	195158	90323948
Dry mouth	169.57	25.39	548	108793	183511	90335595
Gait inability	167.88	25.39	471	108870	145985	90373121
Vital capacity decreased	167.69	25.39	68	109273	1751	90517355
Nasal congestion	163.97	25.39	331	109010	83083	90436023
Diarrhoea	163.41	25.39	584	108757	938606	89580500
Disease progression	162.41	25.39	6	109335	156609	90362497
Sputum culture positive	156.89	25.39	69	109272	2184	90516922
Anaemia	155.41	25.39	119	109222	352683	90166423
White blood cell count decreased	153.14	25.39	13	109328	167096	90352010
Nausea	150.37	25.39	760	108581	1109556	89409550
Cardiac murmur	148.89	25.39	144	109197	18050	90501056
Fatigue	147.86	25.39	805	108536	1153218	89365888
Blood lactic acid increased	146.50	25.39	105	109236	8673	90510433
Pulmonary mass	146.15	25.39	177	109164	28595	90490511
Hyponatraemia	142.44	25.39	4	109337	133534	90385572
Haemoglobin decreased	142.04	25.39	15	109326	161941	90357165
Irritable bowel syndrome	141.72	25.39	560	108781	206888	90312218
Pyrexia	138.51	25.39	377	108964	660108	89858998
Platelet count decreased	136.23	25.39	7	109334	136962	90382144
Muscle injury	133.08	25.39	492	108849	176162	90342944
Psoriatic arthropathy	133.00	25.39	587	108754	227748	90291358
Bacterial disease carrier	132.70	25.39	58	109283	1808	90517298
Coeliac disease	129.84	25.39	210	109131	44400	90474706
Somnolence	128.17	25.39	46	109295	209038	90310068
Bronchopulmonary aspergillosis allergic	126.00	25.39	70	109271	3696	90515410
Blood cholesterol increased	125.90	25.39	541	108800	207471	90311635
Constipation	122.91	25.39	95	109246	280300	90238806
Urticaria	122.46	25.39	719	108622	312015	90207091
Sepsis	121.95	25.39	33	109308	179781	90339325
Memory impairment	120.91	25.39	515	108826	196729	90322377
Injection site reaction	119.40	25.39	310	109031	91770	90427336
Fibromyalgia	119.14	25.39	529	108812	205740	90313366
Hypokalaemia	115.34	25.39	12	109329	131104	90388002
Sleep disorder	114.47	25.39	508	108833	197522	90321584
Death	114.40	25.39	237	109104	456314	90062792
Total lung capacity decreased	112.04	25.39	65	109276	3730	90515376
Dyspnoea exertional	111.35	25.39	260	109081	72028	90447078
Multiple allergies	111.19	25.39	113	109228	15033	90504073
Rales	110.62	25.39	115	109226	15712	90503394
Hypomania	110.02	25.39	89	109252	8808	90510298
Musculoskeletal pain	109.52	25.39	453	108888	170798	90348308
Muscle spasms	107.71	25.39	593	108748	251290	90267816
Liver injury	107.36	25.39	449	108892	170118	90348988
Migraine	106.72	25.39	484	108857	189908	90329198
Jaundice cholestatic	106.65	25.39	92	109249	9951	90509155
Erythema	102.59	25.39	76	109265	229170	90289936
Bronchial obstruction	99.42	25.39	46	109295	1643	90517463
Superinfection	99.10	25.39	56	109285	3056	90516050
Grip strength decreased	98.54	25.39	290	109051	92286	90426820
Hypocholesterolaemia	96.00	25.39	72	109269	6377	90512729
Blood test abnormal	95.36	25.39	122	109219	20830	90498276
Overlap syndrome	94.23	25.39	80	109261	8468	90510638
Cardiac failure	93.83	25.39	11	109330	109485	90409621
Chronic obstructive pulmonary disease	93.09	25.39	246	109095	73583	90445523
Seizure	92.81	25.39	34	109307	152595	90366511
Paraesthesia	92.48	25.39	567	108774	249759	90269347
Bronchial wall thickening	92.16	25.39	47	109294	2084	90517022
Sneezing	91.57	25.39	144	109197	29725	90489381
Factor V Leiden mutation	88.83	25.39	27	109314	284	90518822
Lung opacity	88.34	25.39	67	109274	6035	90513071
Anti-cyclic citrullinated peptide antibody positive	88.26	25.39	537	108804	235896	90283210
Asthmatic crisis	88.09	25.39	44	109297	1866	90517240
Bradycardia	87.65	25.39	3	109338	83844	90435262
Rhinitis	86.68	25.39	94	109247	13478	90505628
Neuropathy peripheral	85.87	25.39	29	109312	136941	90382165
Respiratory failure	85.61	25.39	19	109322	118399	90400707
Respiratory symptom	85.40	25.39	57	109284	4195	90514911
Lung neoplasm malignant	84.28	25.39	124	109217	24149	90494957
Deep vein thrombosis	84.27	25.39	7	109334	91613	90427493
Ill-defined disorder	84.23	25.39	443	108898	184448	90334658
Leukopenia	84.14	25.39	11	109330	100699	90418407
Asthma	83.53	25.39	539	108802	241621	90277485
Accidental exposure to product	83.08	25.39	168	109173	42198	90476908
Rheumatic fever	82.63	25.39	385	108956	152736	90366370
Impaired healing	81.84	25.39	523	108818	233676	90285430
Helicobacter infection	81.38	25.39	510	108831	226340	90292766
Drug-induced liver injury	80.47	25.39	266	109075	90052	90429054
Hepatic enzyme	80.30	25.39	60	109281	5284	90513822
Renal failure	79.96	25.39	29	109312	130978	90388128
Cardiac arrest	79.66	25.39	15	109326	104920	90414186
Hepatitis	78.55	25.39	225	109116	70514	90448592
Underdose	78.55	25.39	190	109151	53827	90465279
Balance disorder	77.84	25.39	12	109329	97068	90422038
Pericarditis	77.64	25.39	575	108766	269576	90249530
Duodenal ulcer perforation	76.59	25.39	493	108848	220795	90298311
Prolonged expiration	76.38	25.39	35	109306	1222	90517884
Schizophrenia	76.14	25.39	92	109249	14822	90504284
Septic shock	75.86	25.39	7	109334	84153	90434953
Respiratory tract infection	75.65	25.39	198	109143	58880	90460226
Gastrointestinal haemorrhage	75.05	25.39	10	109331	90238	90428868
Depression	74.90	25.39	619	108722	299982	90219124
Suicide attempt	74.51	25.39	4	109337	75395	90443711
Middle insomnia	73.82	25.39	96	109245	16655	90502451
Blood glucose increased	73.63	25.39	13	109328	95233	90423873
Syncope	73.46	25.39	34	109307	132629	90386477
Asthma exercise induced	72.41	25.39	26	109315	475	90518631
Coma	71.31	25.39	4	109337	72628	90446478
Hypoglycaemia	71.29	25.39	3	109338	69845	90449261
Wound	69.74	25.39	613	108728	302367	90216739
Hyperhidrosis	69.40	25.39	39	109302	136266	90382840
Injury	69.10	25.39	441	108900	196908	90322198
Eosinophilic granulomatosis with polyangiitis	68.56	25.39	41	109300	2489	90516617
Agitation	68.09	25.39	3	109338	67095	90452011
Platelet count increased	67.35	25.39	103	109238	20756	90498350
Interstitial lung disease	67.17	25.39	7	109334	76398	90442708
General physical health deterioration	66.14	25.39	687	108654	354428	90164678
Nasopharyngitis	65.04	25.39	764	108577	406340	90112766
Vasculitis	64.90	25.39	106	109235	22587	90496519
Hypoaesthesia	64.86	25.39	621	108720	313589	90205517
Cognitive disorder	64.68	25.39	5	109336	69402	90449704
Heart sounds	63.75	25.39	30	109311	1114	90517992
Abdominal pain	62.73	25.39	255	109086	395466	90123640
Bronchospasm	62.32	25.39	99	109242	20610	90498496
Myocardial infarction	62.10	25.39	25	109316	105947	90413159
Feeling abnormal	62.10	25.39	66	109275	167169	90351937
Blister	61.85	25.39	522	108819	254476	90264630
Epistaxis	60.84	25.39	14	109327	85111	90433995
Loss of consciousness	60.79	25.39	48	109293	140190	90378916
Intentional product use issue	60.79	25.39	459	108882	216433	90302673
Weight decreased	60.73	25.39	244	109097	379666	90139440
Renal impairment	59.96	25.39	26	109315	105395	90413711
Synovitis	59.54	25.39	634	108707	329118	90189988
Wrong technique in product usage process	59.35	25.39	8	109333	71563	90447543
C-reactive protein abnormal	58.47	25.39	306	109035	127123	90391983
Vomiting	58.40	25.39	639	108702	787654	89731452
Drug abuse	57.95	25.39	14	109327	82333	90436773
Intentional product misuse	57.87	25.39	18	109323	89586	90429520
Dysphagia	57.34	25.39	32	109309	112246	90406860
Broncholithiasis	56.19	25.39	19	109322	288	90518818
Lymph node calcification	55.47	25.39	20	109321	370	90518736
Pulmonary embolism	55.18	25.39	46	109295	130774	90388332
Pemphigus	55.12	25.39	620	108721	326244	90192862
Infection	54.49	25.39	238	109103	361856	90157250
Blood immunoglobulin E increased	54.15	25.39	44	109297	4381	90514725
Vocal cord dysfunction	54.13	25.39	25	109316	889	90518217
Psoriasis	54.09	25.39	59	109282	147695	90371411
Cystitis	54.05	25.39	8	109333	66710	90452396
Lacrimation increased	53.88	25.39	108	109233	26954	90492152
Kyphosis	53.68	25.39	37	109304	2871	90516235
Normal newborn	53.58	25.39	99	109242	23263	90495843
Pneumonia	53.55	25.39	1073	108268	636986	89882120
Increased bronchial secretion	53.49	25.39	33	109308	2120	90516986
Sleep disorder due to general medical condition, insomnia type	53.36	25.39	46	109295	128648	90390458
Cardio-respiratory arrest	52.49	25.39	7	109334	63133	90455973
Eye pruritus	52.10	25.39	111	109230	28916	90490190
Glossodynia	50.52	25.39	602	108739	321177	90197929
Thrombosis	50.49	25.39	13	109328	73238	90445868
Sinus operation	50.42	25.39	36	109305	2955	90516151
Suicidal ideation	49.22	25.39	14	109327	73841	90445265
Skin ulcer	48.42	25.39	3	109338	50072	90469034
Hospitalisation	48.42	25.39	292	109049	127808	90391298
Drug ineffective	48.17	25.39	1288	108053	1383010	89136096
CFTR gene mutation	47.91	25.39	16	109325	233	90518873
Laryngeal stenosis	47.86	25.39	26	109315	1313	90517793
Sputum purulent	47.62	25.39	26	109315	1326	90517780
Oedema	47.57	25.39	107	109234	200188	90318918
Back pain	47.39	25.39	209	109132	316966	90202140
Scoliosis	47.20	25.39	56	109285	8851	90510255
Hallucination	46.83	25.39	11	109330	65948	90453158
Dry skin	46.58	25.39	24	109317	88049	90431057
Abdominal pain upper	46.07	25.39	608	108733	332066	90187040
Abdominal distension	45.79	25.39	292	109049	130309	90388797
Angioedema	45.71	25.39	11	109330	64865	90454241
Dyspepsia	45.07	25.39	400	108941	197760	90321346
Skin exfoliation	45.02	25.39	13	109328	67900	90451206
Rhinorrhoea	44.67	25.39	218	109123	88098	90431008
Nematodiasis	44.16	25.39	10	109331	27	90519079
Chronic sinusitis	43.85	25.39	92	109249	23710	90495396
Femur fracture	43.85	25.39	3	109338	46079	90473027
Sinus disorder	43.63	25.39	115	109226	34332	90484774
Cerebrovascular accident	43.39	25.39	51	109290	123482	90395624
Aspiration	43.12	25.39	72	109269	15621	90503485
Headache	42.86	25.39	758	108583	861988	89657118
Chills	42.70	25.39	58	109283	131923	90387183
International normalised ratio increased	42.47	25.39	4	109337	47312	90471794
Gait disturbance	42.43	25.39	166	109175	260330	90258776
Sputum retention	41.91	25.39	19	109322	647	90518459
Maternal exposure during pregnancy	41.82	25.39	638	108703	359425	90159681
Cellulitis	41.19	25.39	30	109311	91307	90427799
Mobility decreased	41.07	25.39	473	108868	250261	90268845
Nonspecific reaction	41.01	25.39	31	109310	2778	90516328
Anxiety	39.97	25.39	215	109126	309557	90209549
Sputum culture	39.66	25.39	15	109326	319	90518787
Dysgeusia	38.87	25.39	8	109333	52552	90466554
Dysarthria	38.85	25.39	9	109332	54473	90464633
Neurosensory hypoacusis	37.46	25.39	13	109328	214	90518892
Venous pressure jugular increased	37.38	25.39	17	109324	583	90518523
Hyperglycaemia	37.19	25.39	8	109333	50962	90468144
Respiratory tract inflammation	36.85	25.39	17	109324	603	90518503
Systemic lupus erythematosus	36.33	25.39	626	108715	361270	90157836
Peak expiratory flow rate decreased	36.28	25.39	17	109324	625	90518481
Rheumatoid factor positive	35.82	25.39	98	109243	171552	90347554
Muscular weakness	35.71	25.39	394	108947	206272	90312834
COVID-19	35.54	25.39	96	109245	168747	90350359
Unevaluable event	35.45	25.39	11	109330	54837	90464269
Visual impairment	35.42	25.39	66	109275	132299	90386807
Swelling face	35.05	25.39	28	109313	81324	90437782
Sinusitis	35.03	25.39	256	109085	342832	90176274
Incorrect product administration duration	34.80	25.39	74	109267	19248	90499858
Gamma-glutamyltransferase increased	34.62	25.39	3	109338	37949	90481157
Staphylococcal infection	34.54	25.39	8	109333	48431	90470675
Pleural effusion	34.46	25.39	51	109290	111940	90407166
Mouth ulceration	34.28	25.39	4	109337	39970	90479136
Product use in unapproved indication	34.24	25.39	583	108758	335653	90183453
Eye pain	34.19	25.39	6	109335	44162	90474944
Disorientation	34.14	25.39	6	109335	44108	90474998
Hepatic enzyme increased	34.07	25.39	618	108723	360118	90158988
Respiratory gas exchange disorder	33.33	25.39	14	109327	395	90518711
Influenza like illness	33.19	25.39	29	109312	80582	90438524
Tinnitus	33.05	25.39	6	109335	43096	90476010
Foetal exposure during pregnancy	32.92	25.39	6	109335	42969	90476137
Pulmonary function test decreased	32.03	25.39	33	109308	4461	90514645
Hypomagnesaemia	31.96	25.39	3	109338	35585	90483521
Ascites	31.90	25.39	9	109332	47731	90471375
Lymphocyte count decreased	31.36	25.39	3	109338	35047	90484059
Mycobacterium avium complex infection	30.86	25.39	31	109310	4067	90515039
Pericardial effusion	30.81	25.39	4	109337	36829	90482277
Blood pressure systolic increased	30.70	25.39	16	109325	58329	90460777
Aphasia	30.67	25.39	7	109334	42805	90476301
Hand deformity	30.58	25.39	515	108826	295847	90223259
Flushing	30.58	25.39	37	109304	88454	90430652
Psychotic disorder	30.55	25.39	95	109246	31135	90487971
Congenital anomaly	30.53	25.39	38	109303	6309	90512797
Pulmonary hypertension	30.37	25.39	7	109334	42516	90476590
Dry eye	30.32	25.39	16	109325	57915	90461191
Fluid retention	30.26	25.39	37	109304	88054	90431052
Clostridium difficile infection	30.17	25.39	4	109337	36241	90482865
Tremor	30.09	25.39	90	109251	153083	90366023
Haemorrhage	29.73	25.39	24	109317	69345	90449761
Blood pressure fluctuation	29.68	25.39	13	109328	52400	90466706
Arthritis	29.60	25.39	103	109238	167212	90351894
Disturbance in attention	29.47	25.39	10	109331	47099	90472007
Flatulence	29.17	25.39	7	109334	41360	90477746
Pollakiuria	29.07	25.39	3	109338	33002	90486104
Cholelithiasis	29.02	25.39	133	109208	52373	90466733
Intestinal obstruction	28.84	25.39	5	109336	37126	90481980
Red blood cell count decreased	28.72	25.39	10	109331	46341	90472765
Premature delivery	28.45	25.39	6	109335	38756	90480350
Bone pain	28.42	25.39	20	109321	61963	90457143
Sinonasal obstruction	28.32	25.39	11	109330	252	90518854
Herpes zoster	28.25	25.39	44	109297	94600	90424506
Respiration abnormal	28.11	25.39	41	109300	7922	90511184
Tympanosclerosis	27.84	25.39	8	109333	68	90519038
Presyncope	27.73	25.39	3	109338	31802	90487304
Blood insulin abnormal	27.72	25.39	7	109334	34	90519072
Foot deformity	27.68	25.39	19	109322	59632	90459474
Secretion discharge	27.62	25.39	60	109281	15836	90503270
Tachycardia	27.27	25.39	98	109243	157575	90361531
Body temperature increased	27.10	25.39	10	109331	44700	90474406
Vaccination site haemorrhage	27.07	25.39	7	109334	38	90519068
Forced expiratory volume decreased	26.71	25.39	34	109307	5774	90513332
Cardiac disorder	26.54	25.39	18	109323	56854	90462252
Ulcer	26.50	25.39	4	109337	32878	90486228
Lymphadenopathy	26.49	25.39	11	109330	45764	90473342
Injection site erythema	26.45	25.39	49	109292	98453	90420653
Mite allergy	26.44	25.39	15	109326	825	90518281
Hypervolaemia	26.36	25.39	4	109337	32753	90486353
Decreased appetite	26.30	25.39	309	109032	376231	90142875
Blood calcium increased	26.28	25.39	50	109291	12008	90507098
Therapy cessation	26.28	25.39	100	109241	36261	90482845
Heart rate decreased	26.25	25.39	16	109325	53489	90465617
Blood pressure decreased	26.21	25.39	31	109310	74864	90444242
Dyskinesia	26.12	25.39	6	109335	36528	90482578
Chest pain	26.08	25.39	253	109088	319392	90199714
Oligoarthritis	25.94	25.39	13	109328	555	90518551
Knee arthroplasty	25.47	25.39	38	109303	83144	90435962

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	1798.91	33.96	821	26995	53960	42539559
Therapeutic product effect incomplete	1565.08	33.96	810	27006	70129	42523390
Full blood count abnormal	1231.31	33.96	526	27290	29350	42564169
Sleep disorder due to a general medical condition	1138.61	33.96	428	27388	17025	42576494
Obstructive airways disorder	1029.99	33.96	439	27377	24320	42569199
Loss of personal independence in daily activities	1003.26	33.96	536	27280	49280	42544239
Productive cough	743.27	33.96	446	27370	51121	42542398
Dyspnoea	627.15	33.96	1067	26749	441554	42151965
Asthma	564.32	33.96	403	27413	61911	42531608
Eosinophilic granulomatosis with polyangiitis	495.19	33.96	193	27623	8445	42585074
Respiratory symptom	383.59	33.96	173	27643	10933	42582586
Eosinophil count increased	376.01	33.96	169	27647	10594	42582925
Product dose omission issue	364.88	33.96	475	27341	153890	42439629
Cough	364.73	33.96	511	27305	177592	42415927
Forced expiratory volume decreased	312.47	33.96	134	27682	7496	42586023
Vasculitis	279.84	33.96	165	27651	18229	42575290
Nasal polyps	274.74	33.96	101	27715	3750	42589769
Lung disorder	272.98	33.96	236	27580	47687	42545832
Sputum discoloured	264.10	33.96	130	27686	10002	42583517
Pulmonary vasculitis	259.72	33.96	111	27705	6155	42587364
Neuritis	253.90	33.96	109	27707	6111	42587408
Chest discomfort	239.34	33.96	249	27567	63367	42530152
Haemoptysis	222.62	33.96	207	27609	45960	42547559
Total lung capacity abnormal	222.21	33.96	90	27726	4353	42589166
Neurological symptom	210.36	33.96	111	27705	9880	42583639
Product complaint	209.17	33.96	94	27722	5883	42587636
Acute kidney injury	208.98	33.96	7	27809	367330	42226189
Conjunctivitis allergic	203.80	33.96	92	27724	5819	42587700
Diarrhoea	202.94	33.96	30	27786	460819	42132700
Spirometry abnormal	196.37	33.96	86	27730	5060	42588459
Chronic sinusitis	195.05	33.96	76	27740	3316	42590203
Mite allergy	194.73	33.96	85	27731	4961	42588558
Mycotic allergy	194.00	33.96	84	27732	4807	42588712
Breath sounds abnormal	193.18	33.96	112	27704	11981	42581538
Dust allergy	187.04	33.96	84	27732	5248	42588271
Bronchopulmonary aspergillosis allergic	185.76	33.96	80	27736	4518	42589001
Antineutrophil cytoplasmic antibody positive	173.24	33.96	75	27741	4290	42589229
Lower respiratory tract infection	168.89	33.96	169	27647	41037	42552482
Pulmonary alveolar haemorrhage	164.89	33.96	109	27707	14707	42578812
Nodule	156.18	33.96	99	27717	12435	42581084
Blood immunoglobulin E increased	156.12	33.96	66	27750	3559	42589960
Chronic obstructive pulmonary disease	156.09	33.96	199	27617	62915	42530604
Exposure via skin contact	153.59	33.96	72	27744	4966	42588553
Normochromic normocytic anaemia	147.85	33.96	85	27731	8946	42584573
Nausea	143.26	33.96	41	27775	396758	42196761
Respiratory disorder	140.51	33.96	116	27700	21969	42571550
Nasal congestion	135.85	33.96	129	27687	29372	42564147
Bronchial obstruction	133.19	33.96	48	27768	1681	42591838
Pulmonary fibrosis	133.12	33.96	122	27694	26559	42566960
Bronchiectasis	125.95	33.96	100	27716	17919	42575600
Blood test abnormal	122.34	33.96	86	27730	12820	42580699
Vital capacity decreased	118.59	33.96	33	27783	484	42593035
Wrong technique in device usage process	118.07	33.96	50	27766	2707	42590812
Dyspnoea exertional	117.50	33.96	154	27662	49994	42543525
Obesity	110.04	33.96	89	27727	16370	42577149
Neutropenia	109.14	33.96	5	27811	199426	42394093
Arteriosclerosis coronary artery	108.29	33.96	93	27723	18584	42574935
Asthma-chronic obstructive pulmonary disease overlap syndrome	107.91	33.96	40	27776	1519	42592000
Thrombocytopenia	106.70	33.96	4	27812	190275	42403244
Accidental exposure to product	105.15	33.96	95	27721	20298	42573221
Hospitalisation	99.62	33.96	176	27640	74154	42519365
Hypothyroidism	96.90	33.96	112	27704	31972	42561547
Mycobacterial infection	96.66	33.96	43	27773	2625	42590894
Rhinorrhoea	96.04	33.96	111	27705	31683	42561836
Arteriosclerosis	95.11	33.96	85	27731	17904	42575615
Obstruction	93.51	33.96	44	27772	3059	42590460
Hypoxia	93.20	33.96	165	27651	69621	42523898
Pulmonary function test abnormal	93.07	33.96	42	27774	2652	42590867
Hypotension	92.12	33.96	27	27789	257604	42335915
Upper respiratory tract infection	91.85	33.96	125	27691	42048	42551471
Multiple allergies	88.76	33.96	45	27771	3683	42589836
Capillaritis	87.48	33.96	38	27778	2190	42591329
Reversible airways obstruction	83.36	33.96	26	27790	577	42592942
Bronchial hyperreactivity	82.66	33.96	35	27781	1894	42591625
Eosinophil count abnormal	77.63	33.96	22	27794	346	42593173
Sleep disorder	76.53	33.96	123	27693	47972	42545547
Anxiety	76.36	33.96	209	27607	118351	42475168
Bronchiolitis	75.47	33.96	41	27775	3865	42589654
Sinusitis	75.32	33.96	121	27695	47171	42546348
Vomiting	74.27	33.96	49	27767	289674	42303845
Parathyroid gland enlargement	72.21	33.96	18	27798	167	42593352
Upper respiratory fungal infection	71.36	33.96	18	27798	176	42593343
Airway remodelling	69.37	33.96	25	27791	875	42592644
Anaemia	68.39	33.96	50	27766	280228	42313291
Eosinophilia	67.85	33.96	95	27721	32804	42560715
Foetal malformation	66.52	33.96	17	27799	176	42593343
Upper-airway cough syndrome	65.92	33.96	39	27777	4327	42589192
Eye disorder	63.62	33.96	56	27760	11556	42581963
Secretion discharge	63.49	33.96	47	27769	7588	42585931
Sinus congestion	62.65	33.96	45	27771	6935	42586584
Pulmonary function test decreased	60.93	33.96	41	27775	5691	42587828
Seizure	60	33.96	5	27811	120556	42472963
Coagulation factor V level abnormal	59.71	33.96	15	27801	144	42593375
White blood cell count decreased	59.60	33.96	3	27813	110393	42483126
Gastrooesophageal reflux disease	59.49	33.96	106	27710	44917	42548602
Eosinophilic bronchitis	57.16	33.96	16	27800	240	42593279
Decreased appetite	56.10	33.96	28	27788	193109	42400410
Lung diffusion test decreased	55.19	33.96	21	27795	858	42592661
Condition aggravated	53.30	33.96	321	27495	260433	42333086
Asthmatic crisis	53.13	33.96	18	27798	523	42592996
Nasal disorder	52.99	33.96	26	27790	1983	42591536
Forced expiratory volume	52.91	33.96	13	27803	113	42593406
Sepsis	51.99	33.96	33	27783	199301	42394218
Cardiac failure	51.64	33.96	5	27811	106851	42486668
Coagulation factor deficiency	51.46	33.96	15	27801	262	42593257
Dizziness	50.45	33.96	53	27763	249201	42344318
Dehydration	50.34	33.96	15	27801	141752	42451767
Lung hyperinflation	50.06	33.96	21	27795	1110	42592409
Restrictive pulmonary disease	49.48	33.96	22	27794	1341	42592178
Pulmonary mass	49.46	33.96	57	27759	16208	42577311
Lung diffusion disorder	48.74	33.96	13	27803	161	42593358
Influenza	48.65	33.96	118	27698	62057	42531462
Thrombosis	47.31	33.96	124	27692	68387	42525132
Adjustment disorder	46.60	33.96	21	27795	1321	42592198
Cardiac arrest	45.91	33.96	8	27808	109312	42484207
Illness	45.57	33.96	68	27748	24862	42568657
Disease progression	44.53	33.96	19	27797	143637	42449882
Inspiratory capacity abnormal	44.43	33.96	11	27805	99	42593420
Renal impairment	44.30	33.96	9	27807	110219	42483300
Snoring	43.63	33.96	29	27787	3944	42589575
Therapy cessation	43.57	33.96	60	27756	20390	42573129
Mycobacterium test positive	43.47	33.96	15	27801	461	42593058
Lymphadenopathy	43.36	33.96	78	27738	33287	42560232
Bronchial disorder	42.67	33.96	20	27796	1378	42592141
Polyp	41.99	33.96	30	27786	4584	42588935
Overdose	41.47	33.96	9	27807	105255	42488264
Trisomy 18	41.45	33.96	17	27799	848	42592671
Sputum purulent	41.09	33.96	16	27800	696	42592823
Oesophageal polyp	39.54	33.96	9	27807	54	42593465
Hypercholesterolaemia	39.02	33.96	45	27771	12804	42580715
Aspartate aminotransferase increased	38.94	33.96	3	27813	77160	42516359
Anosmia	38.91	33.96	30	27786	5146	42588373
Use of accessory respiratory muscles	38.26	33.96	14	27802	512	42593007
Nephrectomy	37.35	33.96	16	27800	891	42592628
Fall	37.02	33.96	60	27756	234460	42359059
Pleural effusion	36.90	33.96	9	27807	97157	42496362
Congenital hiatus hernia	36.29	33.96	31	27785	6143	42587376
Atopy	36.24	33.96	16	27800	959	42592560
Factor V Leiden mutation	36.02	33.96	11	27805	227	42593292
Death	35.91	33.96	172	27644	471013	42122506
Renal failure	35.83	33.96	25	27791	143701	42449818
Septic shock	35.78	33.96	8	27808	91664	42501855
Intentional product use issue	35.67	33.96	3	27813	71830	42521689
Asthenia	35.50	33.96	82	27734	280711	42312808
Rhinitis allergic	35.01	33.96	25	27791	3817	42589702
Urinary tract infection	34.34	33.96	11	27805	99273	42494246

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	2970.46	27.71	2396	123312	252834	110210757
Full blood count abnormal	1898.24	27.71	1028	124680	55024	110408567
Obstructive airways disorder	1679.36	27.71	888	124820	45261	110418330
Therapeutic product effect incomplete	1652.10	27.71	1626	124082	222179	110241412
Sleep disorder due to a general medical condition	1521.44	27.71	867	124841	51245	110412346
Loss of personal independence in daily activities	1236.55	27.71	1159	124549	148861	110314730
Productive cough	908.79	27.71	866	124842	113439	110350152
Nasal polyps	767.80	27.71	350	125358	12850	110450741
Dyspnoea	712.51	27.71	2806	122902	1104066	109359525
Gastrooesophageal reflux disease	689.47	27.71	933	124775	179043	110284548
Blepharospasm	650.39	27.71	522	125186	54329	110409262
Acute kidney injury	636.15	27.71	19	125689	635411	109828180
Onychomadesis	631.43	27.71	476	125232	45187	110418404
Sputum discoloured	612.79	27.71	387	125321	27558	110436033
Lung disorder	585.30	27.71	863	124845	179184	110284407
Cough	552.97	27.71	1451	124257	460190	110003401
Drug interaction	519.40	27.71	10	125698	500173	109963418
Toxicity to various agents	514.35	27.71	6	125702	480549	109983042
Eosinophil count increased	495.44	27.71	305	125403	20753	110442838
Nail disorder	483.17	27.71	451	125257	57484	110406107
Taste disorder	482.88	27.71	476	125232	64911	110398680
Back injury	472.39	27.71	408	125300	46991	110416600
Hypercholesterolaemia	455.72	27.71	539	125169	90298	110373293
Upper-airway cough syndrome	454.85	27.71	261	125447	15596	110447995
Onychomycosis	440.43	27.71	359	125349	38172	110425419
Breast cancer stage III	434.69	27.71	492	125216	78625	110384966
Obesity	423.72	27.71	581	125127	112770	110350821
Rhinitis allergic	417.61	27.71	258	125450	17664	110445927
Eosinophilic granulomatosis with polyangiitis	412.25	27.71	214	125494	10472	110453119
Peripheral venous disease	406.93	27.71	490	125218	83627	110379964
Chest discomfort	395.43	27.71	709	124999	173139	110290452
Asthma-chronic obstructive pulmonary disease overlap syndrome	393.62	27.71	176	125532	6168	110457423
Neutropenia	382.82	27.71	9	125699	374611	110088980
Product quality issue	381.64	27.71	455	125253	76844	110386747
Respiratory symptom	365.73	27.71	222	125486	14723	110448868
Bronchiectasis	357.29	27.71	311	125397	36182	110427409
Facet joint syndrome	352.37	27.71	490	125218	96338	110367253
Epilepsy	345.25	27.71	494	125214	99715	110363876
Breath sounds abnormal	344.88	27.71	262	125446	25142	110438449
Hypotension	344.09	27.71	86	125622	523763	109939828
Lower respiratory tract infection	343.96	27.71	815	124893	242291	110221300
Pulmonary function test abnormal	340.19	27.71	148	125560	4852	110458739
Thrombocytopenia	336.35	27.71	14	125694	348871	110114720
Eosinophilia	324.53	27.71	364	125344	57572	110406019
Night sweats	316.92	27.71	556	125152	133427	110330164
Bursitis	316.25	27.71	546	125162	129372	110334219
Wound infection	296.90	27.71	451	125257	96014	110367577
Lip dry	292.71	27.71	457	125251	99626	110363965
Bronchial secretion retention	291.46	27.71	133	125575	4891	110458700
Total lung capacity increased	289.25	27.71	133	125575	4979	110458612
Reversible airways obstruction	287.80	27.71	108	125600	2391	110461200
Folliculitis	283.99	27.71	604	125104	167049	110296542
Vasculitis	275.71	27.71	267	125441	35606	110427985
Liver function test increased	273.93	27.71	415	125293	88133	110375458
Type 2 diabetes mellitus	269.03	27.71	611	125097	176621	110286970
Bronchopulmonary aspergillosis allergic	266.84	27.71	148	125560	8278	110455313
Joint range of motion decreased	259.34	27.71	483	125225	121349	110342242
Finger deformity	251.88	27.71	245	125463	32847	110430744
Diarrhoea	249.72	27.71	582	125126	1138923	109324668
Vital capacity decreased	247.54	27.71	92	125616	1981	110461610
Nasal congestion	241.69	27.71	415	125293	97867	110365724
Asthma	241.28	27.71	728	124980	249563	110214028
Forced expiratory volume decreased	238.80	27.71	162	125546	13014	110450577
Sleep disorder	233.68	27.71	621	125087	198023	110265568
Anaemia	232.21	27.71	170	125538	546916	109916675
Dehydration	232.07	27.71	24	125684	279487	110184104
Irritable bowel syndrome	227.20	27.71	546	125162	163669	110299922
Product dose omission issue	226.71	27.71	842	124866	320940	110142651
Muscle injury	217.62	27.71	489	125219	140318	110323273
Adverse reaction	217.58	27.71	215	125493	29379	110434212
Osteoarthritis	215.89	27.71	572	125136	182051	110281540
White blood cell count decreased	212.05	27.71	12	125696	229378	110234213
Neck pain	211.22	27.71	446	125262	122684	110340907
Death	210.17	27.71	293	125415	698576	109765015
Ear pruritus	209.54	27.71	120	125588	7140	110456451
Sepsis	208.56	27.71	57	125651	327289	110136302
Urinary tract infection	207.53	27.71	57	125651	326225	110137366
Product label confusion	207.46	27.71	186	125522	22491	110441100
Chest X-ray abnormal	202.35	27.71	124	125584	8363	110455228
Chronic obstructive pulmonary disease	200.87	27.71	407	125301	108751	110354840
Multiple allergies	199.28	27.71	141	125567	12122	110451469
Pulmonary vasculitis	198.95	27.71	112	125596	6448	110457143
Live birth	197.19	27.71	313	125395	69171	110394420
Disease progression	194.91	27.71	24	125684	244010	110219581
Pemphigus	193.62	27.71	610	125098	213960	110249631
Inflammation	192.73	27.71	569	125139	192669	110270922
Psoriatic arthropathy	192.09	27.71	575	125133	196186	110267405
Neuritis	191.62	27.71	114	125594	7285	110456306
Gait inability	189.22	27.71	454	125254	135922	110327669
Blood test abnormal	185.42	27.71	194	125514	28360	110435231
Sarcoidosis	184.70	27.71	136	125572	12443	110451148
Total lung capacity abnormal	183.16	27.71	94	125614	4489	110459102
Malignant neoplasm progression	183.01	27.71	3	125705	174564	110289027
Mite allergy	178.50	27.71	100	125608	5703	110457888
Dyspnoea exertional	177.39	27.71	376	125332	103684	110359907
Nausea	177.03	27.71	764	124944	1234926	109228665
Fibromyalgia	176.89	27.71	510	125198	170399	110293192
C-reactive protein increased	173.71	27.71	594	125114	217325	110246266
Glossodynia	173.36	27.71	601	125107	221403	110242188
Cardiac failure	172.84	27.71	10	125698	187616	110275975
Blood cholesterol increased	170.07	27.71	529	125179	184256	110279335
Product complaint	169.85	27.71	135	125573	13837	110449754
Anti-cyclic citrullinated peptide antibody positive	169.36	27.71	523	125185	181461	110282130
Pyrexia	168.77	27.71	495	125213	897770	109565821
Dust allergy	167.35	27.71	97	125611	5904	110457687
Dry mouth	167.31	27.71	554	125154	199394	110264197
Haemoglobin decreased	166.71	27.71	39	125669	248688	110214903
Infusion site reaction	165.66	27.71	147	125561	17535	110446056
Wound	163.78	27.71	612	125096	233825	110229766
Pruritus	162.86	27.71	256	125452	581304	109882287
Aspartate aminotransferase increased	162.66	27.71	4	125704	159932	110303659
Spirometry abnormal	161.71	27.71	92	125616	5405	110458186
Bronchial obstruction	161.45	27.71	76	125632	3003	110460588
Cardiac arrest	157.97	27.71	19	125689	196734	110266857
Seizure	157.84	27.71	30	125678	221155	110242436
Bradycardia	157.74	27.71	4	125704	155513	110308078
Helicobacter infection	157.61	27.71	510	125198	181367	110282224
Drug abuse	153.17	27.71	13	125695	177398	110286193
Liver injury	151.94	27.71	445	125263	149968	110313623
Memory impairment	150.14	27.71	529	125179	196415	110267176
Pulmonary mass	149.64	27.71	198	125510	37103	110426488
Haemoptysis	149.43	27.71	281	125427	71073	110392518
Gastrointestinal haemorrhage	148.93	27.71	10	125698	165508	110298083
Eosinophil count abnormal	148.08	27.71	53	125655	1021	110462570
Ill-defined disorder	148.00	27.71	453	125255	156400	110307191
Pericarditis	147.26	27.71	565	125143	218549	110245042
Impaired healing	147.06	27.71	525	125183	196192	110267399
Off label use	146.84	27.71	1052	124656	1499133	108964458
Coeliac disease	145.87	27.71	211	125497	42976	110420615
Blood immunoglobulin E increased	145.21	27.71	96	125612	7386	110456205
Migraine	143.94	27.71	476	125232	171176	110292415
Systemic lupus erythematosus	142.55	27.71	620	125088	253718	110209873
Conjunctivitis allergic	142.01	27.71	92	125616	6839	110456752
Hyperkalaemia	139.63	27.71	3	125705	135793	110327798
Injection site reaction	139.44	27.71	311	125397	88759	110374832
Rheumatic fever	138.81	27.71	378	125330	122201	110341390
Mycotic allergy	136.88	27.71	85	125623	5869	110457722
Duodenal ulcer perforation	136.04	27.71	478	125230	177222	110286369
Chronic sinusitis	136.00	27.71	155	125553	24929	110438662
Wrong technique in device usage process	135.04	27.71	89	125619	6812	110456779
Grip strength decreased	131.23	27.71	285	125423	79889	110383702
Septic shock	129.49	27.71	14	125694	157514	110306077
Hyponatraemia	129.33	27.71	43	125665	217610	110245981
Leukopenia	128.17	27.71	11	125697	148780	110314811
Cardiac murmur	128.17	27.71	149	125559	24479	110439112
Somnolence	127.92	27.71	91	125617	297358	110166233
Hypokalaemia	127.53	27.71	26	125682	182422	110281169
Renal failure	127.41	27.71	49	125659	226525	110237066
Exposure via skin contact	126.56	27.71	111	125597	13036	110450555
Urticaria	126.30	27.71	704	125004	318153	110145438
Synovitis	126.27	27.71	631	125077	273461	110190130
Nasopharyngitis	125.85	27.71	823	124885	393538	110070053
Antineutrophil cytoplasmic antibody positive	125.72	27.71	76	125632	5000	110458591
Constipation	125.34	27.71	133	125575	357653	110105938
Bacterial disease carrier	125.14	27.71	58	125650	2211	110461380
Maternal exposure during pregnancy	124.00	27.71	596	125112	254287	110209304
Renal impairment	121.50	27.71	32	125676	188413	110275178
Fatigue	120.56	27.71	849	124859	1215109	109248482
Coma	119.65	27.71	3	125705	117866	110345725
Hypoglycaemia	117.69	27.71	3	125705	116101	110347490
Sputum culture positive	116.86	27.71	66	125642	3823	110459768
Neurological symptom	115.85	27.71	114	125594	15494	110448097
Musculoskeletal pain	115.69	27.71	463	125245	182560	110281031
Rhinorrhoea	113.65	27.71	314	125394	102352	110361239
Depressed level of consciousness	109.84	27.71	4	125704	112274	110351317
Hand deformity	109.21	27.71	515	125193	217991	110245600
Hypomania	108.03	27.71	91	125617	10119	110453472
Agitation	107.33	27.71	5	125703	113046	110350545
Erythema	107.00	27.71	104	125604	291343	110172248
Sneezing	104.72	27.71	154	125554	31830	110431761
Paraesthesia	104.51	27.71	603	125105	275918	110187673
Cardio-respiratory arrest	104.19	27.71	7	125701	115829	110347762
Hypoaesthesia	104.02	27.71	662	125046	313561	110150030
Loss of consciousness	103.06	27.71	47	125661	196259	110267332
Muscle spasms	100.87	27.71	600	125108	277557	110186034
Asthmatic crisis	100.54	27.71	49	125659	2093	110461498
Hypocholesterolaemia	100.12	27.71	72	125636	6349	110457242
Hyperhidrosis	99.65	27.71	44	125664	187254	110276337
Lung opacity	99.58	27.71	92	125616	11560	110452031
Prolonged expiration	99.30	27.71	44	125664	1508	110462083
Overlap syndrome	98.45	27.71	82	125626	8977	110454614
Blood lactic acid increased	98.29	27.71	105	125603	15716	110447875
Rales	97.19	27.71	130	125578	24609	110438982
Suicide attempt	96.79	27.71	5	125703	103389	110360202
Middle insomnia	95.12	27.71	117	125591	20385	110443206
Injury	94.63	27.71	426	125282	176839	110286752
Multiple organ dysfunction syndrome	93.63	27.71	28	125680	151682	110311909
Lethargy	92.71	27.71	3	125705	93573	110370018
Mucosal inflammation	92.10	27.71	4	125704	96137	110367454
Blister	90.62	27.71	503	125205	226873	110236718
Blood glucose increased	90.30	27.71	20	125688	132476	110331115
Epistaxis	90.23	27.71	19	125689	130353	110333238
Neutrophil count decreased	89.30	27.71	15	125693	120926	110342665
Total lung capacity decreased	89.18	27.71	70	125638	7044	110456547
Dysphagia	88.38	27.71	32	125676	153568	110310023
Jaundice cholestatic	85.59	27.71	94	125614	14514	110449077
Pulmonary alveolar haemorrhage	85.54	27.71	110	125598	20040	110443551
Hepatic enzyme	85.36	27.71	60	125648	5103	110458488
Myocardial infarction	84.90	27.71	57	125651	192026	110271565
Hepatic function abnormal	84.61	27.71	4	125704	89291	110374300
International normalised ratio increased	81.85	27.71	4	125704	86768	110376823
Normochromic normocytic anaemia	79.95	27.71	86	125622	12971	110450620
Abdominal pain	78.83	27.71	308	125400	512681	109950910
Interstitial lung disease	78.53	27.71	30	125678	139304	110324287
Vomiting	77.78	27.71	662	125046	910013	109553578
Depression	76.79	27.71	620	125088	316715	110146876
Obstruction	75.15	27.71	58	125650	5694	110457897
Syncope	74.63	27.71	72	125636	202464	110261127
Neuropathy peripheral	74.25	27.71	57	125651	179220	110284371
Hepatic enzyme increased	72.86	27.71	618	125090	320274	110143317
Rheumatoid arthritis	72.83	27.71	586	125122	299027	110164564
Eye pruritus	72.27	27.71	132	125576	32643	110430948
C-reactive protein abnormal	71.70	27.71	315	125393	129380	110334211
Rash maculo-papular	71.39	27.71	3	125705	74219	110389372
Chills	71.10	27.71	67	125641	190513	110273078
Angioedema	71.01	27.71	13	125695	98487	110365104
Drug reaction with eosinophilia and systemic symptoms	70.88	27.71	6	125702	82089	110381502
Superinfection	70.72	27.71	56	125652	5707	110457884
Respiratory failure	69.97	27.71	85	125623	215247	110248344
Lacrimation increased	69.96	27.71	126	125582	30824	110432767
Mobility decreased	68.77	27.71	484	125224	236938	110226653
Lung neoplasm malignant	68.02	27.71	131	125577	33711	110429880
Mycobacterial infection	67.66	27.71	49	125659	4368	110459223
Respiratory tract infection	67.65	27.71	207	125501	71410	110392181
Back pain	67.60	27.71	207	125501	370789	110092802
Pulmonary fibrosis	67.56	27.71	262	125446	101780	110361811
Pleural effusion	66.85	27.71	62	125646	177647	110285944
Cerebrovascular accident	66.15	27.71	65	125643	181219	110282372
COVID-19	65.54	27.71	111	125597	244949	110218642
Heart sounds	65.49	27.71	30	125678	1113	110462478
Dysarthria	65.38	27.71	9	125699	84112	110379479
Deep vein thrombosis	65.26	27.71	39	125669	139848	110323743
General physical health deterioration	64.42	27.71	753	124955	424542	110039049
Capillaritis	64.26	27.71	38	125670	2401	110461190
Balance disorder	64.20	27.71	26	125682	116534	110347057
Normal newborn	63.99	27.71	100	125608	21796	110441795
Secretion discharge	62.73	27.71	95	125613	20149	110443442
Bronchial wall thickening	61.88	27.71	41	125667	3166	110460425
Hypocalcaemia	61.69	27.71	3	125705	65363	110398228
Ascites	61.27	27.71	15	125693	92793	110370798
Airway remodelling	61.22	27.71	27	125681	915	110462676
Hospitalisation	60.64	27.71	321	125387	142172	110321419
Suicidal ideation	60.44	27.71	16	125692	93921	110369670
Cognitive disorder	60.05	27.71	13	125695	87498	110376093
Hyperglycaemia	59.71	27.71	12	125696	85078	110378513
Abdominal pain upper	59.64	27.71	633	125075	348478	110115113
Parathyroid gland enlargement	59.23	27.71	18	125690	202	110463389
Underdose	58.46	27.71	182	125526	63372	110400219
Bronchiolitis	58.20	27.71	49	125659	5444	110458147
Bronchial hyperreactivity	58.16	27.71	41	125667	3503	110460088
Feeling abnormal	58.00	27.71	72	125636	180639	110282952
Dyspepsia	57.47	27.71	393	125315	190572	110273019
Gamma-glutamyltransferase increased	57.27	27.71	3	125705	61306	110402285
Sinus operation	57.13	27.71	38	125670	2953	110460638
Rhinitis	56.43	27.71	96	125612	22449	110441142
Pulmonary function test decreased	56.28	27.71	59	125649	8641	110454950
Hypomagnesaemia	56.25	27.71	3	125705	60367	110403224
Schizophrenia	56.04	27.71	94	125614	21732	110441859
Haematuria	55.61	27.71	13	125695	82992	110380599
Sinus disorder	55.44	27.71	118	125590	32610	110430981
Kyphosis	54.94	27.71	38	125670	3149	110460442
Vocal cord dysfunction	54.63	27.71	25	125683	925	110462666
Hepatitis	54.63	27.71	225	125483	89829	110373762
Broncholithiasis	54.21	27.71	18	125690	274	110463317
Increased bronchial secretion	54.19	27.71	41	125667	3907	110459684
Restrictive pulmonary disease	54.17	27.71	38	125670	3221	110460370
Lung diffusion disorder	54.09	27.71	18	125690	276	110463315
Haematocrit decreased	54.01	27.71	6	125702	66111	110397480
Disorientation	53.90	27.71	8	125700	70663	110392928
Bronchospasm	53.52	27.71	111	125597	30128	110433463
Decreased appetite	53.12	27.71	320	125388	475526	109988065
Lymphocyte count decreased	52.85	27.71	3	125705	57240	110406351
Arteriosclerosis coronary artery	52.67	27.71	99	125609	25019	110438572
Weight decreased	51.08	27.71	317	125391	467740	109995851
Dysgeusia	50.96	27.71	9	125699	69976	110393615
Staphylococcal infection	50.92	27.71	9	125699	69935	110393656
Scoliosis	50.82	27.71	56	125652	8677	110454914
Platelet count increased	50.57	27.71	100	125608	26234	110437357
Intentional product misuse	50.42	27.71	46	125662	132858	110330733
Oedema	50.04	27.71	102	125606	209874	110253717
Cardiogenic shock	50.03	27.71	4	125704	57334	110406257
Upper respiratory tract infection	49.95	27.71	287	125421	131041	110332550
Cytomegalovirus infection	49.82	27.71	3	125705	54441	110409150
Drug-induced liver injury	49.40	27.71	268	125440	119799	110343792
Aspiration	49.33	27.71	108	125600	30425	110433166
Shock	48.90	27.71	3	125705	53585	110410006
Nodule	48.89	27.71	112	125596	32519	110431072
CFTR gene mutation	48.84	27.71	16	125692	233	110463358
Laryngeal stenosis	48.26	27.71	26	125682	1372	110462219
Upper respiratory fungal infection	47.52	27.71	18	125690	409	110463182
Chronic kidney disease	47.21	27.71	14	125694	76277	110387314
Blood creatinine increased	46.93	27.71	85	125623	182804	110280787
Blood calcium increased	46.73	27.71	78	125630	17962	110445629
Accidental exposure to product	46.72	27.71	144	125564	49864	110413727
Haematemesis	46.71	27.71	6	125702	59102	110404489
Aphasia	46.59	27.71	6	125702	58991	110404600
Therapeutic product effect decreased	46.49	27.71	453	125255	243863	110219728
Coagulation factor V level abnormal	46.48	27.71	14	125694	152	110463439
Polyp	46.37	27.71	57	125651	9923	110453668
Infusion related reaction	46.29	27.71	648	125060	380514	110083077
Gastritis	46.15	27.71	4	125704	53695	110409896
Drug ineffective for unapproved indication	46.12	27.71	30	125678	102808	110360783
Tachycardia	46.02	27.71	120	125588	226525	110237066
Lymph node calcification	45.88	27.71	18	125690	451	110463140
Sputum abnormal	45.69	27.71	25	125683	1361	110462230
Intestinal obstruction	45.65	27.71	4	125704	53223	110410368
Contraindicated product administered	45.62	27.71	457	125251	247810	110215781
Acute respiratory distress syndrome	45.62	27.71	4	125704	53194	110410397
Eosinophilic bronchitis	45.33	27.71	19	125689	567	110463024
Intentional product use issue	44.91	27.71	455	125253	247451	110216140
Nematodiasis	44.76	27.71	10	125698	27	110463564
Drug intolerance	43.83	27.71	677	125031	405835	110057756
Flushing	43.74	27.71	33	125675	104703	110358888
Leukocytosis	43.68	27.71	5	125703	53823	110409768
Product prescribing error	43.64	27.71	4	125704	51327	110412264
Illness	43.46	27.71	197	125511	81974	110381617
Respiratory disorder	43.02	27.71	178	125530	71204	110392387
Forced expiratory volume	43.00	27.71	12	125696	97	110463494
Blood pressure fluctuation	42.34	27.71	16	125692	74808	110388783
Hallucination	42.31	27.71	32	125676	101400	110362191
Hypervolaemia	41.66	27.71	4	125704	49456	110414135
Tinnitus	41.52	27.71	9	125699	60531	110403060
Hypercalcaemia	41.43	27.71	3	125705	46654	110416937
Red blood cell count decreased	40.97	27.71	12	125696	65911	110397680
Disturbance in attention	40.96	27.71	10	125698	61985	110401606
Sputum purulent	40.88	27.71	26	125682	1872	110461719
Pulmonary hypertension	40.43	27.71	7	125701	55213	110408378
Blood pressure systolic increased	40.33	27.71	22	125686	82969	110380622
Swelling face	39.97	27.71	28	125680	92293	110371298
Swelling	39.92	27.71	590	125118	350451	110113140
Psoriasis	39.68	27.71	61	125647	139932	110323659
Haematoma	39.49	27.71	9	125699	58467	110405124
Arteriosclerosis	39.33	27.71	87	125621	24680	110438911
Haematochezia	39.24	27.71	44	125664	115480	110348111
Respiration abnormal	39.23	27.71	52	125656	9757	110453834
Dyskinesia	38.83	27.71	6	125702	51440	110412151
Therapy non-responder	38.69	27.71	75	125633	157232	110306359
Cellulitis	38.59	27.71	52	125656	125964	110337627
Atopy	38.55	27.71	21	125687	1133	110462458
Incorrect product administration duration	38.35	27.71	77	125631	20421	110443170
Inspiratory capacity abnormal	38.08	27.71	11	125697	102	110463489
Lip swelling	38.03	27.71	6	125702	50661	110412930
Nonspecific reaction	38.00	27.71	30	125678	3044	110460547
Swollen tongue	37.49	27.71	11	125697	60351	110403240
Mycobacterium test positive	37.28	27.71	17	125691	624	110462967
Exposure during pregnancy	37.19	27.71	321	125387	167103	110296488
Lung hyperinflation	37.07	27.71	26	125682	2203	110461388
Medication error	37.04	27.71	39	125669	105327	110358264
Cerebral infarction	37.02	27.71	7	125701	51831	110411760
Coagulation factor deficiency	36.97	27.71	14	125694	318	110463273
Peripheral swelling	36.95	27.71	655	125053	403379	110060212
Emphysema	36.71	27.71	74	125634	19682	110443909
Arthropathy	36.60	27.71	493	125215	287029	110176562
Body temperature increased	35.81	27.71	9	125699	54704	110408887
Hypophagia	35.74	27.71	8	125700	52618	110410973
Drug hypersensitivity	35.30	27.71	718	124990	453372	110010219
Hypertension	35.30	27.71	793	124915	509291	109954300
Fungal disease carrier	34.90	27.71	15	125693	477	110463114
Congenital anomaly	34.76	27.71	19	125689	1032	110462559
Respiratory gas exchange disorder	34.68	27.71	18	125690	880	110462711
Pleuritic pain	34.32	27.71	64	125644	16076	110447515
Femur fracture	33.99	27.71	5	125703	44464	110419127
Dysuria	33.88	27.71	13	125695	60218	110403373
Nasal disorder	33.44	27.71	32	125676	4202	110459389
Heart rate decreased	33.39	27.71	27	125681	82729	110380862
Mouth ulceration	33.33	27.71	7	125701	48131	110415460
Eye pain	33.26	27.71	8	125700	50091	110413500
Osteonecrosis of jaw	33.21	27.71	7	125701	48010	110415581
Neurosensory hypoacusis	32.88	27.71	12	125696	245	110463346
Atelectasis	32.71	27.71	104	125604	36608	110426983
Delirium	32.67	27.71	65	125643	134960	110328631
Drug withdrawal syndrome	32.26	27.71	3	125705	38051	110425540
Wrong technique in product usage process	32.22	27.71	31	125677	87317	110376274
Adverse drug reaction	32.19	27.71	218	125490	105341	110358250
Pneumonia aspiration	32.16	27.71	27	125681	81206	110382385
Respiratory tract inflammation	32.15	27.71	18	125690	1025	110462566
Herpes zoster	31.90	27.71	46	125662	108333	110355258
Blood pressure decreased	31.81	27.71	51	125657	115040	110348551
Abdominal pain lower	31.44	27.71	3	125705	37280	110426311
Lung diffusion test decreased	31.43	27.71	21	125687	1644	110461947
Unevaluable event	31.35	27.71	14	125694	59213	110404378
Electrolyte imbalance	31.17	27.71	3	125705	37025	110426566
Crepitations	30.99	27.71	49	125659	10786	110452805
Fluid retention	30.86	27.71	37	125671	94270	110369321
Ventricular fibrillation	30.77	27.71	5	125703	41308	110422283
Subdural haematoma	30.57	27.71	3	125705	36451	110427140
Sputum culture	30.54	27.71	12	125696	302	110463289
Pneumonia	30.51	27.71	1252	124456	875462	109588129
Oesophageal polyp	30.46	27.71	9	125699	91	110463500
Blood pressure diastolic decreased	29.97	27.71	3	125705	35882	110427709
Bronchial disorder	29.90	27.71	25	125683	2751	110460840
Stomatitis	29.85	27.71	452	125256	269790	110193801
Drug ineffective	29.70	27.71	1420	124288	1519120	108944471
Respiratory distress	29.67	27.71	21	125687	68853	110394738
Pollakiuria	29.45	27.71	7	125701	44188	110419403
Candida infection	29.36	27.71	9	125699	48000	110415591
Gastric ulcer	29.26	27.71	5	125703	39822	110423769
Oral pain	29.11	27.71	4	125704	37440	110426151
Sleep disorder due to general medical condition, insomnia type	29.02	27.71	47	125661	105596	110357995
Fall	28.96	27.71	497	125211	602985	109860606
Sputum retention	27.75	27.71	18	125690	1341	110462250

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
CHEBI has role	CHEBI:65023	anti-asthmatic agent

Related Drugs by ATC class:

R03DX Other systemic drugs for obstructive airway diseases 10 drugs

amlexanoxbenralizumabdepemokimab-ulaaeprozinolfenspirideomalizumabreslizumabroflumilastseratrodasttezepelumab

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
CHEBI:753401	CHEBI
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	0173-0892	INJECTION, SOLUTION	100 mg	SUBCUTANEOUS	BLA	27 sections
Nucala	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0904	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	BLA	27 sections