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

Stem definition	Drug id	CAS RN
human origin	5224	1190264-60-8

Description:

Molecule	Description
Synonyms: dupilumab REGN668 SAR231893 dupixent	Dupilumab is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor. Blocking IL-4Rα with dupilumab inhibits IL-4 and IL-13 cytokine-induced responses, including the release of proinflammatory cytokines, chemokines and IgE. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

dupilumab
REGN668
SAR231893
dupixent

Dupilumab is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor. Blocking IL-4Rα with dupilumab inhibits IL-4 and IL-13 cytokine-induced responses, including the release of proinflammatory cytokines, chemokines and IgE.

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

Drug dosage:

Dose	Unit	Route
21.40	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company
July 3, 2017	EMA	sanofi-aventis groupe
March 28, 2017	FDA	REGENERON PHARMACEUTICALS
Jan. 19, 2018	PMDA	Sanofi KK

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
Product use in unapproved indication	12924.62	25.45	6800	136932	172280	63173010
Injection site pain	7329.28	25.45	4204	139528	125596	63219694
Product dose omission issue	6162.86	25.45	4708	139024	229605	63115685
Pruritus	4941.00	25.45	5006	138726	356447	62988843
Eczema	4469.54	25.45	1929	141803	30362	63314928
Dry eye	3969.06	25.45	1906	141826	38855	63306435
Dry skin	3767.74	25.45	2051	141681	54836	63290454
Product use issue	3686.52	25.45	3418	140314	217102	63128188
Eye pruritus	3686.37	25.45	1439	142293	17232	63328058
Rash	3295.86	25.45	5088	138644	555783	62789507
Impaired quality of life	3153.38	25.45	1183	142549	12600	63332690
Injection site swelling	2822.14	25.45	1596	142136	45976	63299314
Eye irritation	2601.10	25.45	1177	142555	20794	63324496
Product dose omission in error	2518.50	25.45	859	142873	6753	63338537
Injection site erythema	2506.41	25.45	1820	141912	81354	63263936
Skin exfoliation	2392.50	25.45	1385	142347	41717	63303573
Ocular hyperaemia	2274.79	25.45	1119	142613	24025	63321265
COVID-19	2157.43	25.45	1892	141840	111211	63234079
Inappropriate schedule of product administration	2122.24	25.45	1808	141924	102157	63243133
Conjunctivitis	1954.31	25.45	950	142782	19846	63325444
Injection site rash	1848.34	25.45	886	142846	17923	63327367
Therapeutic response shortened	1593.12	25.45	695	143037	11193	63334097
Sleep disorder	1545.05	25.45	1360	142372	80206	63265084
Injection site pruritus	1520.73	25.45	1058	142674	44058	63301232
Incorrect dose administered	1467.95	25.45	1160	142572	58808	63286482
Therapeutic response decreased	1205.10	25.45	1046	142686	60479	63284811
Skin fissures	1172.16	25.45	554	143178	10834	63334456
Injection site reaction	1152.30	25.45	998	142734	57526	63287764
Injection site urticaria	1147.52	25.45	584	143148	13489	63331801
Oral herpes	919.44	25.45	629	143103	25445	63319845
Injection site bruising	915.68	25.45	759	142973	41151	63304139
Rash macular	882.06	25.45	588	143144	22776	63322514
Product preparation error	867.92	25.45	372	143360	5720	63339570
Accidental exposure to product	851.92	25.45	612	143120	26793	63318497
Erythema	846.43	25.45	1465	142267	174286	63171004
Skin burning sensation	824.26	25.45	453	143279	12281	63333009
Vision blurred	800.57	25.45	1013	142719	90911	63254379
Product prescribing issue	789.68	25.45	278	143454	2421	63342869
Illness	740.02	25.45	721	143011	48338	63296952
Drug effect less than expected	716.28	25.45	230	143502	1459	63343831
Condition aggravated	704.08	25.45	2252	141480	399965	62945325
Rash erythematous	624.74	25.45	616	143116	41894	63303396
Lacrimation increased	616.69	25.45	450	143282	20181	63325109
Diarrhoea	604.50	25.45	445	143287	714921	62630369
Drug intolerance	579.06	25.45	29	143703	308632	63036658
Skin swelling	575.77	25.45	236	143496	3223	63342067
Eye discharge	554.29	25.45	272	143460	5791	63339499
Eye pain	547.22	25.45	517	143215	33337	63311953
Acute kidney injury	546.66	25.45	10	143722	263405	63081885
Death	546.63	25.45	95	143637	374286	62971004
Skin haemorrhage	545.09	25.45	319	143413	9775	63335515
Toxicity to various agents	532.23	25.45	5	143727	247245	63098045
Injection site dryness	530.71	25.45	134	143598	284	63345006
Eye swelling	523.95	25.45	434	143298	23484	63321806
Nausea	511.02	25.45	717	143015	853754	62491536
Product storage error	508.74	25.45	353	143379	14603	63330687
Vomiting	497.41	25.45	329	143403	559288	62786002
Intentional dose omission	497.17	25.45	278	143454	7797	63337493
Infusion related reaction	495.04	25.45	13	143719	245508	63099782
Dermatitis atopic	479.94	25.45	290	143442	9434	63335856
Contraindicated product administered	475.26	25.45	3	143729	217645	63127645
Anaemia	463.72	25.45	59	143673	293371	63051919
Drug ineffective	460.93	25.45	3971	139761	1040794	62304496
Injection site irritation	460.08	25.45	225	143507	4753	63340537
SARS-CoV-2 test positive	449.31	25.45	260	143472	7796	63337494
Eye disorder	422.27	25.45	375	143357	22310	63322980
Eyelids pruritus	417.51	25.45	139	143593	1003	63344287
Hypotension	416.06	25.45	61	143671	272543	63072747
Injection site mass	413.77	25.45	341	143391	18315	63326975
Synovitis	405.93	25.45	3	143729	186915	63158375
Eyelid margin crusting	397.98	25.45	132	143600	940	63344350
Device use issue	385.83	25.45	164	143568	2466	63342824
Rheumatoid arthritis	379.98	25.45	60	143672	253759	63091531
Hepatic enzyme increased	372.98	25.45	21	143711	202307	63142983
Arthralgia	372.66	25.45	2381	141351	567329	62777961
Skin weeping	371.08	25.45	115	143617	638	63344652
Drug interaction	369.44	25.45	43	143689	229088	63116202
Periorbital swelling	366.23	25.45	163	143569	2755	63342535
Injection site exfoliation	361.99	25.45	97	143635	284	63345006
Swelling of eyelid	357.12	25.45	164	143568	2992	63342298
Asthenia	350.60	25.45	218	143514	383386	62961904
Neutropenia	349.92	25.45	10	143722	174995	63170295
Rebound eczema	348.50	25.45	69	143663	3	63345287
Confusional state	344.63	25.45	60	143672	236320	63108970
Lack of injection site rotation	340.19	25.45	96	143636	360	63344930
Rebound atopic dermatitis	338.81	25.45	74	143658	50	63345240
Discomfort	336.20	25.45	985	142747	166389	63178901
Erythema of eyelid	333.54	25.45	142	143590	2144	63343146
Treatment failure	331.95	25.45	33	143699	199010	63146280
Glossodynia	328.35	25.45	19	143713	178857	63166433
Extra dose administered	325.34	25.45	194	143538	6156	63339134
Blepharitis	322.19	25.45	146	143586	2579	63342711
Skin irritation	322.12	25.45	226	143506	9515	63335775
Systemic lupus erythematosus	320.41	25.45	46	143686	208872	63136418
Thrombocytopenia	316.47	25.45	5	143727	151152	63194138
Completed suicide	313.06	25.45	3	143729	145670	63199620
Arthropathy	312.37	25.45	74	143658	234718	63110572
General physical health deterioration	307.33	25.45	45	143687	201357	63143933
Abdominal pain	301.12	25.45	144	143588	293312	63051978
Eyelid skin dryness	293.82	25.45	70	143662	102	63345188
Haemoglobin decreased	291.98	25.45	8	143724	145477	63199813
Scratch	281.41	25.45	179	143553	6386	63338904
Visual impairment	274.57	25.45	597	143135	83849	63261441
Dermatitis	273.99	25.45	259	143473	16699	63328591
Pneumonia	263.27	25.45	392	143340	456375	62888915
Pericarditis	257.68	25.45	9	143723	131570	63213720
Fatigue	254.28	25.45	1093	142639	886935	62458355
Decreased appetite	250.22	25.45	128	143604	250924	63094366
Fall	248.85	25.45	314	143418	392020	62953270
Oedema peripheral	245.64	25.45	63	143669	189448	63155842
Joint swelling	242.21	25.45	231	143501	327435	63017855
Wrong technique in device usage process	241.08	25.45	131	143601	3467	63341823
Urticaria	237.55	25.45	870	142862	164932	63180358
White blood cell count decreased	237.35	25.45	21	143711	139083	63206207
Lower respiratory tract infection	236.93	25.45	16	143716	132291	63212999
Wound	236.64	25.45	42	143690	163221	63182069
Hypertension	233.24	25.45	175	143557	279128	63066162
Hyponatraemia	232.95	25.45	4	143728	111896	63233394
Constipation	232.77	25.45	109	143623	224834	63120456
Eyelid rash	229.63	25.45	57	143675	109	63345181
Injection site discolouration	225.03	25.45	167	143565	7681	63337609
Surgery	220.88	25.45	335	143397	35577	63309713
Abdominal discomfort	218.15	25.45	243	143489	320642	63024648
Sepsis	216.33	25.45	42	143690	153081	63192209
Eye inflammation	216.25	25.45	143	143589	5456	63339834
Alanine aminotransferase increased	214.82	25.45	4	143728	103766	63241524
Platelet count decreased	211.02	25.45	13	143719	116109	63229181
Overdose	208.77	25.45	13	143719	115065	63230225
Hospitalisation	204.57	25.45	535	143197	84546	63260744
Fear of injection	199.95	25.45	150	143582	7014	63338276
Hordeolum	199.00	25.45	112	143620	3180	63342110
Dehydration	193.69	25.45	75	143657	173279	63172011
Pulmonary embolism	187.68	25.45	22	143710	116662	63228628
Renal failure	187.22	25.45	23	143709	117629	63227661
Intentional product use issue	185.09	25.45	33	143699	127859	63217431
Aspartate aminotransferase increased	184.78	25.45	4	143728	90273	63255017
Rash pruritic	183.30	25.45	413	143319	59386	63285904
Helicobacter infection	182.87	25.45	6	143726	92779	63252511
Weight decreased	180.10	25.45	217	143515	276581	63068709
Impaired healing	178.99	25.45	14	143718	102528	63242762
Disease progression	176.95	25.45	32	143700	122726	63222564
Injection site discomfort	175.79	25.45	117	143615	4513	63340777
Blood creatinine increased	175.58	25.45	5	143727	87839	63257451
Eyelid irritation	174.52	25.45	60	143672	483	63344807
Injection site vesicles	173.79	25.45	99	143633	2878	63342412
Off label use of device	167.01	25.45	51	143681	267	63345023
Pleural effusion	164.75	25.45	12	143720	93198	63252092
Blood pressure increased	162.31	25.45	82	143650	161980	63183310
Pyrexia	162.02	25.45	536	143196	469942	62875348
Device defective	161.55	25.45	82	143650	1880	63343410
Cardiac arrest	160.51	25.45	13	143719	92532	63252758
Leukopenia	159.88	25.45	3	143729	77287	63268003
Pain of skin	158.69	25.45	162	143570	11472	63333818
Ocular discomfort	158.38	25.45	106	143626	4127	63341163
Respiratory failure	157.06	25.45	22	143710	101836	63243454
C-reactive protein increased	157.02	25.45	16	143716	94691	63250599
Needle issue	155.38	25.45	152	143580	10224	63335066
Intentional overdose	152.89	25.45	3	143729	74149	63271141
Periorbital irritation	152.79	25.45	30	143702	0	63345290
Tachycardia	151.66	25.45	40	143692	118116	63227174
Gastrointestinal haemorrhage	150.81	25.45	8	143724	81168	63264122
Drug abuse	149.26	25.45	3	143729	72515	63272775
Somnolence	148.99	25.45	112	143620	178573	63166717
Bradycardia	146.97	25.45	4	143728	73223	63272067
Stomatitis	145.32	25.45	66	143666	138659	63206631
Burning sensation	144.14	25.45	355	143377	54052	63291238
Eczema eyelids	143.85	25.45	39	143693	121	63345169
Renal impairment	143.73	25.45	16	143716	88339	63256951
Injection site warmth	142.52	25.45	174	143558	15021	63330269
Skin discolouration	142.25	25.45	284	143448	37544	63307746
Seizure	142.25	25.45	61	143671	132573	63212717
Injection site haemorrhage	141.34	25.45	221	143511	24093	63321197
Mobility decreased	141.07	25.45	49	143683	121110	63224180
Eyelid exfoliation	140.61	25.45	39	143693	135	63345155
Sensitive skin	139.01	25.45	72	143660	1724	63343566
Unevaluable event	136.88	25.45	336	143396	51050	63294240
Musculoskeletal stiffness	135.26	25.45	131	143601	184487	63160803
Atrial fibrillation	134.38	25.45	48	143684	116588	63228702
Septic shock	132.40	25.45	4	143728	66625	63278665
Musculoskeletal pain	130.95	25.45	25	143707	92252	63253038
Eye infection	130.35	25.45	149	143583	11996	63333294
Unintentional use for unapproved indication	130.05	25.45	38	143694	166	63345124
Muscle injury	129.56	25.45	4	143728	65341	63279949
Psoriatic arthropathy	129.44	25.45	25	143707	91495	63253795
Deep vein thrombosis	129.42	25.45	18	143714	83782	63261508
Irritable bowel syndrome	128.95	25.45	17	143715	82395	63262895
Injection site eczema	127.47	25.45	31	143701	52	63345238
Cardiac failure	126.82	25.45	24	143708	89118	63256172
Depressed level of consciousness	126.06	25.45	3	143729	62075	63283215
Urinary tract infection	125.91	25.45	256	143476	264428	63080862
Blood cholesterol increased	124.21	25.45	30	143702	94002	63251288
Oedema	121.63	25.45	35	143697	97587	63247703
Coma	120.64	25.45	6	143726	64358	63280932
Asthma	119.19	25.45	588	143144	126973	63218317
Cardiac failure congestive	119.17	25.45	31	143701	92402	63252888
Folliculitis	118.87	25.45	11	143721	70306	63274984
Skin discomfort	118.27	25.45	47	143685	589	63344701
Rash papular	116.29	25.45	160	143572	15542	63329748
Osteoarthritis	115.48	25.45	36	143696	95307	63249983
Multiple organ dysfunction syndrome	114.26	25.45	3	143729	56749	63288541
Neutrophil count decreased	113.50	25.45	3	143729	56403	63288887
Therapy non-responder	113.30	25.45	18	143714	75883	63269407
Symptom recurrence	113.27	25.45	63	143669	1747	63343543
Suicide attempt	113.16	25.45	6	143726	60912	63284378
Skin disorder	112.70	25.45	223	143509	29284	63316006
Gastrointestinal disorder	112.31	25.45	80	143652	131159	63214131
Drug hypersensitivity	111.63	25.45	347	143385	310340	63034950
Injury	110.18	25.45	17	143715	73230	63272060
General physical condition abnormal	109.40	25.45	85	143647	4189	63341101
Malaise	109.37	25.45	527	143205	415427	62929863
Cognitive disorder	108.60	25.45	4	143728	55811	63289479
Quality of life decreased	108.29	25.45	116	143616	8687	63336603
Type 2 diabetes mellitus	107.94	25.45	10	143722	63858	63281432
Tremor	107.52	25.45	85	143647	132154	63213136
Eosinophil count increased	105.52	25.45	127	143605	10801	63334489
Eosinophilic granulomatosis with polyangiitis	104.62	25.45	64	143668	2128	63343162
Medication error	104.39	25.45	3	143729	52281	63293009
Hypoglycaemia	102.60	25.45	9	143723	60056	63285234
Swelling	102.17	25.45	303	143429	275075	63070215
Intercepted product storage error	100.86	25.45	26	143706	62	63345228
Injection site inflammation	97.44	25.45	76	143656	3767	63341523
Eye allergy	94.85	25.45	46	143686	953	63344337
Sleep disorder due to general medical condition, insomnia type	94.37	25.45	6	143726	52211	63293079
Blood pressure systolic increased	93.61	25.45	3	143729	47394	63297896
Drug ineffective for unapproved indication	93.12	25.45	225	143507	33838	63311452
Neuropathy peripheral	92.48	25.45	73	143659	113594	63231696
Hypoxia	91.96	25.45	13	143719	59779	63285511
Middle insomnia	90.89	25.45	127	143605	12516	63332774
C-reactive protein abnormal	90.74	25.45	3	143729	46093	63299197
Cough	89.60	25.45	1035	142697	291708	63053582
Dizziness	89.49	25.45	588	143144	429337	62915953
Perioral dermatitis	87.75	25.45	30	143702	237	63345053
Agitation	87.34	25.45	15	143717	59742	63285548
Back pain	85.94	25.45	308	143424	263837	63081453
Suicidal ideation	84.24	25.45	19	143713	62402	63282888
Liver disorder	84.16	25.45	11	143721	53676	63291614
Myocardial infarction	84.01	25.45	62	143670	99831	63245459
Oropharyngeal pain	83.62	25.45	429	143303	94058	63251232
Rhabdomyolysis	82.68	25.45	4	143728	43947	63301343
Fibromyalgia	81.51	25.45	40	143692	80380	63264910
Syncope	78.41	25.45	90	143642	117295	63227995
Acne	78.29	25.45	167	143565	23126	63322164
Chest pain	77.64	25.45	241	143491	215718	63129572
Loss of consciousness	77.36	25.45	92	143640	118029	63227261
Therapeutic product effect decreased	77.21	25.45	205	143527	192982	63152308
Incorrect dose administered by device	77.18	25.45	70	143662	4278	63341012
Rectal haemorrhage	76.97	25.45	10	143722	49020	63296270
Red blood cell sedimentation rate increased	76.75	25.45	6	143726	43976	63301314
Blood pressure fluctuation	76.30	25.45	8	143724	46309	63298981
Gait disturbance	75.79	25.45	191	143541	182987	63162303
Hallucination	75.36	25.45	16	143716	54801	63290489
Blood alkaline phosphatase increased	74.59	25.45	6	143726	42961	63302329
Chronic kidney disease	74.38	25.45	8	143724	45390	63299900
Off label use	72.93	25.45	1082	142650	673380	62671910
Palpitations	72.61	25.45	89	143643	112681	63232609
Ill-defined disorder	72.37	25.45	48	143684	81707	63263583
Therapeutic response unexpected	71.91	25.45	142	143590	18617	63326673
Balance disorder	71.50	25.45	52	143680	84370	63260920
Drug dose omission by device	71.26	25.45	70	143662	4731	63340559
Multiple sclerosis relapse	71.22	25.45	12	143720	48466	63296824
Haematochezia	70.86	25.45	17	143715	53527	63291763
Conjunctivitis allergic	70.72	25.45	37	143695	905	63344385
Keratitis	70.58	25.45	60	143672	3362	63341928
Hand dermatitis	70.37	25.45	25	143707	224	63345066
Muscular weakness	70.24	25.45	105	143627	122248	63223042
Foreign body sensation in eyes	69.62	25.45	50	143682	2184	63343106
Hyperglycaemia	69.57	25.45	7	143725	41860	63303430
Oxygen saturation decreased	69.43	25.45	59	143673	88526	63256764
Skin depigmentation	68.68	25.45	37	143695	962	63344328
Red blood cell count decreased	67.01	25.45	7	143725	40638	63304652
Skin texture abnormal	66.81	25.45	29	143703	460	63344830
Femur fracture	66.80	25.45	8	143724	41748	63303542
Pulmonary fibrosis	65.26	25.45	7	143725	39802	63305488
Hepatic failure	64.72	25.45	4	143728	35652	63309638
Prescribed overdose	64.59	25.45	3	143729	34150	63311140
Adverse event	63.48	25.45	37	143695	67522	63277768
Dyspepsia	63.35	25.45	83	143649	102113	63243177
Heart rate decreased	63.25	25.45	13	143719	45547	63299743
Asthenopia	63.15	25.45	48	143684	2289	63343001
Blood glucose increased	62.97	25.45	58	143674	83698	63261592
Pain	62.94	25.45	1241	142491	739387	62605903
Orthostatic hypotension	62.91	25.45	5	143727	36155	63309135
Sunburn	61.88	25.45	51	143681	2737	63342553
Drug effective for unapproved indication	61.37	25.45	55	143677	3309	63341981
Respiratory arrest	61.31	25.45	3	143729	32642	63312648
Eosinophilic pneumonia	61.05	25.45	46	143686	2165	63343125
Joint range of motion decreased	60.84	25.45	3	143729	32425	63312865
Drug reaction with eosinophilia and systemic symptoms	60.81	25.45	4	143728	33832	63311458
Pulmonary oedema	60.80	25.45	24	143708	54849	63290441
Foetal exposure during pregnancy	59.83	25.45	3	143729	31959	63313331
Acute respiratory failure	59.35	25.45	5	143727	34480	63310810
Dysphagia	57.99	25.45	69	143663	88516	63256774
Blood pressure decreased	57.78	25.45	38	143694	64984	63280306
Periorbital inflammation	57.77	25.45	16	143716	55	63345235
Coronary artery disease	57.68	25.45	4	143728	32373	63312917
Hypothyroidism	57.48	25.45	13	143719	42619	63302671
Scab	57.32	25.45	79	143653	7684	63337606
Haematemesis	56.47	25.45	3	143729	30409	63314881
Lymphocyte count decreased	56.13	25.45	3	143729	30254	63315036
Transaminases increased	55.52	25.45	4	143728	31363	63313927
Osteoporosis	54.45	25.45	31	143701	57307	63287983
Acute myocardial infarction	54.36	25.45	5	143727	32119	63313171
Dyskinesia	54.10	25.45	5	143727	31997	63313293
Generalised tonic-clonic seizure	53.44	25.45	3	143729	29013	63316277
Pneumonitis	53.36	25.45	8	143724	35214	63310076
Heart rate increased	53.00	25.45	82	143650	94156	63251134
Cholelithiasis	52.44	25.45	17	143715	43908	63301382
Disorientation	51.28	25.45	13	143719	39439	63305851
Liver function test increased	50.76	25.45	7	143725	32804	63312486
Pulmonary hypertension	50.69	25.45	11	143721	37112	63308178
Product quality issue	50.27	25.45	10	143722	35855	63309435
Gastrooesophageal reflux disease	50.25	25.45	87	143645	95552	63249738
Amnesia	50.05	25.45	32	143700	55553	63289737
Hypervolaemia	49.23	25.45	4	143728	28409	63316881
Depression	49.19	25.45	253	143479	196239	63149051
Product administered at inappropriate site	48.78	25.45	47	143685	3102	63342188
Arrhythmia	48.75	25.45	13	143719	38127	63307163
Respiratory distress	48.57	25.45	9	143723	33942	63311348
Haematuria	48.12	25.45	5	143727	29152	63316138
Anosmia	47.96	25.45	68	143664	6792	63338498
Blood calcium decreased	47.91	25.45	3	143729	26448	63318842
Hypophagia	47.59	25.45	7	143725	31252	63314038
Product temperature excursion issue	47.23	25.45	18	143714	200	63345090
Pancreatitis acute	46.58	25.45	4	143728	27162	63318128
Dyspnoea	46.36	25.45	1142	142590	660171	62685119
Full blood count abnormal	46.26	25.45	8	143724	31709	63313581
Maternal exposure during pregnancy	45.16	25.45	302	143430	219760	63125530
Dyspnoea exertional	45.04	25.45	42	143690	60260	63285030
Sinus operation	44.66	25.45	41	143691	2545	63342745
Aphasia	44.61	25.45	10	143722	32990	63312300
Rosacea	44.51	25.45	54	143678	4630	63340660
Cerebral haemorrhage	44.28	25.45	8	143724	30721	63314569
Osteonecrosis	43.79	25.45	3	143729	24527	63320763
Dysarthria	43.65	25.45	21	143711	42690	63302600
Colitis	43.61	25.45	28	143704	48500	63296790
Psychotic disorder	43.51	25.45	4	143728	25708	63319582
Intentional self-injury	43.46	25.45	4	143728	25683	63319607
Urinary retention	43.42	25.45	8	143724	30293	63314997
Bursitis	43.06	25.45	15	143717	37026	63308264
Injury associated with device	42.80	25.45	47	143685	3619	63341671
Skin erosion	42.39	25.45	40	143692	2572	63342718
Anxiety	41.95	25.45	304	143428	217237	63128053
Lethargy	41.84	25.45	39	143693	55968	63289322
Pigmentation disorder	41.69	25.45	52	143680	4587	63340703
Acute respiratory distress syndrome	41.66	25.45	3	143729	23531	63321759
Full blood count decreased	41.59	25.45	5	143727	26019	63319271
Aggression	41.58	25.45	3	143729	23495	63321795
Respiration abnormal	41.06	25.45	61	143671	6356	63338934
White blood cell count increased	41.00	25.45	30	143702	48531	63296759
Foot deformity	40.68	25.45	7	143725	27846	63317444
Fluid retention	40.67	25.45	45	143687	59641	63285649
Periorbital pain	40.25	25.45	12	143720	57	63345233
Sneezing	40.16	25.45	111	143621	18107	63327183
Pharyngeal swelling	39.73	25.45	60	143672	6344	63338946
Stress	39.46	25.45	274	143458	66893	63278397
Osteomyelitis	39.21	25.45	6	143726	26014	63319276
Cerebrovascular accident	39.18	25.45	120	143612	107904	63237386
Metastases to liver	39.15	25.45	4	143728	23635	63321655
Epilepsy	39.10	25.45	7	143725	27058	63318232
Hepatic cirrhosis	38.93	25.45	5	143727	24729	63320561
Angina pectoris	38.92	25.45	10	143722	30068	63315222
Urinary incontinence	38.91	25.45	12	143720	32002	63313288
Basal cell carcinoma	38.82	25.45	8	143724	27983	63317307
Shock	38.78	25.45	4	143728	23459	63321831
Emotional distress	38.15	25.45	13	143719	32536	63312754
Pancreatitis	38.03	25.45	33	143699	49022	63296268
Pallor	37.98	25.45	11	143721	30557	63314733
Drainage	37.67	25.45	15	143717	189	63345101
Product used for unknown indication	37.40	25.45	20	143712	512	63344778
Blood pressure diastolic decreased	37.20	25.45	4	143728	22702	63322588
Pulmonary arterial hypertension	36.93	25.45	4	143728	22573	63322717
Injection site scar	36.91	25.45	25	143707	993	63344297
Blood potassium decreased	36.75	25.45	25	143707	42001	63303289
Nasal polypectomy	36.42	25.45	10	143722	33	63345257
Abdominal pain lower	36.32	25.45	7	143725	25671	63319619
Gastroenteritis	36.06	25.45	8	143724	26582	63318708
Keratoconus	35.67	25.45	9	143723	19	63345271
Frequent bowel movements	35.41	25.45	5	143727	23017	63322273
Night sweats	35.29	25.45	35	143697	48779	63296511
Rash maculo-papular	35.25	25.45	14	143718	31882	63313408
Injection site extravasation	35.19	25.45	68	143664	8773	63336517
Device leakage	35.14	25.45	60	143672	7036	63338254
Disease recurrence	34.99	25.45	10	143722	28020	63317270
Pregnancy	34.85	25.45	20	143712	36816	63308474
Cystitis	34.75	25.45	44	143688	54947	63290343
Hepatic steatosis	34.58	25.45	11	143721	28758	63316532
Injection site nodule	34.48	25.45	43	143689	3792	63341498
Body temperature increased	34.05	25.45	21	143711	37171	63308119
Red blood cell sedimentation rate abnormal	33.68	25.45	3	143729	19779	63325511
SARS-CoV-1 test positive	33.67	25.45	9	143723	26	63345264
Circulatory collapse	33.19	25.45	5	143727	21933	63323357
Device dispensing error	32.97	25.45	12	143720	116	63345174
Facial discomfort	32.96	25.45	11	143721	80	63345210
Laboratory test abnormal	32.86	25.45	10	143722	26902	63318388
Stevens-Johnson syndrome	32.86	25.45	8	143724	24942	63320348
Miliaria	32.64	25.45	25	143707	1206	63344084
Nightmare	32.44	25.45	3	143729	19191	63326099
Nasal congestion	32.40	25.45	257	143475	65403	63279887
Hip arthroplasty	32.38	25.45	36	143696	47610	63297680
Dysuria	32.38	25.45	18	143714	33720	63311570
Proteinuria	32.34	25.45	3	143729	19142	63326148
Cutaneous T-cell lymphoma	32.22	25.45	26	143706	1354	63343936
Abnormal behaviour	32.15	25.45	5	143727	21421	63323869
Hyposmia	32.11	25.45	20	143712	687	63344603
Cellulitis	31.93	25.45	88	143644	81870	63263420
Pericardial effusion	31.92	25.45	14	143718	30044	63315246
Electrolyte imbalance	31.74	25.45	4	143728	20072	63325218
Upper gastrointestinal haemorrhage	31.72	25.45	3	143729	18849	63326441
Skin mass	31.68	25.45	52	143680	5903	63339387
Lack of administration site rotation	31.67	25.45	8	143724	17	63345273
Abdominal pain upper	31.43	25.45	307	143425	206137	63139153
Dysgeusia	30.97	25.45	36	143696	46674	63298616
Exposure during pregnancy	30.75	25.45	509	143223	155038	63190252
Angioedema	30.71	25.45	38	143694	47927	63297363
Lymphopenia	30.62	25.45	3	143729	18324	63326966
Eyelid thickening	30.54	25.45	10	143722	68	63345222
Paranasal sinus discomfort	30.03	25.45	43	143689	4333	63340957
Wound infection	29.94	25.45	6	143726	21404	63323886
Bone disorder	29.77	25.45	6	143726	21320	63323970
Mental disorder	29.75	25.45	127	143605	25792	63319498
Device operational issue	29.68	25.45	14	143718	272	63345018
Post-acute COVID-19 syndrome	29.56	25.45	16	143716	420	63344870
Haemoptysis	29.54	25.45	14	143718	28712	63316578
Haemorrhoids	29.37	25.45	7	143725	22143	63323147
Leukocytosis	29.30	25.45	11	143721	25924	63319366
Cerebral infarction	28.96	25.45	9	143723	23884	63321406
Drug tolerance decreased	28.82	25.45	3	143729	17470	63327820
Abdominal distension	28.78	25.45	100	143632	86515	63258775
Transient ischaemic attack	28.54	25.45	26	143706	37727	63307563
Tooth disorder	28.53	25.45	14	143718	28143	63317147
Injection site hypersensitivity	28.23	25.45	29	143703	2068	63343222
Coagulopathy	28.23	25.45	6	143726	20538	63324752
Small intestinal obstruction	28.16	25.45	4	143728	18333	63326957
Haemorrhage	28.13	25.45	60	143672	60962	63284328
Blood potassium increased	28.10	25.45	4	143728	18305	63326985
Lung disorder	28.05	25.45	62	143670	62199	63283091
Dandruff	28.02	25.45	13	143719	243	63345047
Joint effusion	27.96	25.45	3	143729	17057	63328233
Body temperature decreased	27.78	25.45	6	143726	20313	63324977
Upper-airway cough syndrome	27.61	25.45	72	143660	11346	63333944
Injection site indentation	27.55	25.45	12	143720	192	63345098
Neck pain	27.33	25.45	74	143658	69244	63276046
Photophobia	27.29	25.45	95	143637	17540	63327750
Muscle spasms	26.91	25.45	225	143507	155925	63189365
Hyperhidrosis	26.88	25.45	139	143593	107697	63237593
Treatment noncompliance	26.71	25.45	27	143705	37298	63307992
Infection	26.62	25.45	362	143370	228811	63116479
Obstructive airways disorder	26.56	25.45	7	143725	20692	63324598
Menstrual disorder	26.41	25.45	45	143687	5268	63340022
Haematoma	26.30	25.45	24	143708	34796	63310494
Chronic obstructive pulmonary disease	26.18	25.45	65	143667	62621	63282669
Bacteraemia	26.14	25.45	4	143728	17344	63327946
Flatulence	26.11	25.45	24	143708	34678	63310612
Knee operation	26.11	25.45	48	143684	5965	63339325
Disability	25.96	25.45	5	143727	18342	63326948
Pustule	25.64	25.45	25	143707	1674	63343616
Menstruation irregular	25.62	25.45	52	143680	6952	63338338
Serum sickness	25.61	25.45	32	143700	2828	63342462
Myoclonus	25.48	25.45	3	143729	15865	63329425

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
Product use in unapproved indication	7644.01	33.57	4201	77195	113298	34762237
Pruritus	4283.10	33.57	3129	78267	138852	34736683
Product dose omission issue	4090.86	33.57	2848	78548	116863	34758672
Injection site pain	4040.60	33.57	1917	79479	37088	34838447
Product use issue	3133.88	33.57	1903	79493	61313	34814222
Eczema	2878.01	33.57	1209	80187	17227	34858308
Dry eye	2812.52	33.57	995	80401	8580	34866955
Dry skin	2659.52	33.57	1345	80051	29942	34845593
Rash	2612.34	33.57	2881	78515	219871	34655664
Eye pruritus	2301.18	33.57	805	80591	6684	34868851
Conjunctivitis	2158.72	33.57	822	80574	8883	34866652
Ocular hyperaemia	2133.85	33.57	853	80543	10599	34864936
Injection site swelling	2111.12	33.57	848	80548	10679	34864856
Eye irritation	1824.95	33.57	680	80716	6881	34868654
Product dose omission in error	1739.83	33.57	491	80905	1783	34873752
Impaired quality of life	1663.58	33.57	593	80803	5225	34870310
Inappropriate schedule of product administration	1616.56	33.57	1260	80136	61036	34814499
Skin exfoliation	1538.50	33.57	896	80500	26536	34848999
Sleep disorder	1312.34	33.57	853	80543	30835	34844700
Injection site erythema	1129.84	33.57	607	80789	15292	34860243
Drug ineffective	1109.16	33.57	2915	78481	453836	34421699
Therapeutic response decreased	1087.59	33.57	737	80659	28576	34846959
Therapeutic response shortened	1006.99	33.57	441	80955	6963	34868572
Discomfort	932.01	33.57	569	80827	18369	34857166
Skin fissures	931.51	33.57	378	81018	4881	34870654
COVID-19	853.62	33.57	975	80421	76575	34798960
Incorrect dose administered	761.58	33.57	681	80715	39834	34835701
Erythema	755.47	33.57	980	80416	87800	34787735
Product prescribing issue	702.59	33.57	243	81153	1936	34873599
Injection site pruritus	701.47	33.57	337	81059	6646	34868889
Lacrimation increased	688.13	33.57	354	81042	8128	34867407
Acute kidney injury	664.88	33.57	9	81387	304979	34570556
Injection site rash	609.18	33.57	261	81135	3892	34871643
Arthralgia	599.16	33.57	1260	80136	168781	34706754
Condition aggravated	577.61	33.57	1336	80060	190860	34684675
Vision blurred	576.02	33.57	619	80777	45344	34830191
Injection site urticaria	557.44	33.57	202	81194	1870	34873665
Skin haemorrhage	547.73	33.57	251	81145	4427	34871108
Product preparation error	546.33	33.57	205	81191	2112	34873423
Injection site reaction	539.26	33.57	351	81045	12682	34862853
Rash macular	531.70	33.57	346	81050	12496	34863039
Death	514.79	33.57	146	81250	397903	34477632
Drug effect less than expected	505.45	33.57	165	81231	1076	34874459
Anaemia	476.19	33.57	15	81381	233320	34642215
Illness	456.19	33.57	321	81075	13208	34862327
Injection site bruising	456.18	33.57	272	81124	8391	34867144
Accidental exposure to product	455.65	33.57	314	81082	12488	34863047
Skin burning sensation	450.94	33.57	219	81177	4424	34871111
Drug interaction	445.59	33.57	19	81377	225927	34649608
Toxicity to various agents	444.82	33.57	4	81392	200358	34675177
Device use issue	427.59	33.57	125	81271	529	34875006
Injection site mass	423.45	33.57	236	81160	6390	34869145
Product storage error	422.43	33.57	253	81143	7869	34867666
Oral herpes	399.97	33.57	214	81182	5333	34870202
Eye discharge	378.67	33.57	151	81245	1855	34873680
Rash erythematous	371.53	33.57	369	81027	24608	34850927
Diarrhoea	369.11	33.57	227	81169	389685	34485850
Hypotension	367.62	33.57	43	81353	221606	34653929
Skin weeping	352.20	33.57	101	81295	393	34875142
Intentional dose omission	348.67	33.57	168	81228	3332	34872203
Scratch	346.59	33.57	165	81231	3183	34872352
Skin swelling	333.59	33.57	124	81272	1241	34874294
Dermatitis atopic	332.29	33.57	187	81209	5160	34870375
Pneumonia	320.21	33.57	228	81168	362399	34513136
Thrombocytopenia	311.64	33.57	12	81384	156235	34719300
Periorbital swelling	305.87	33.57	96	81300	541	34874994
Rebound eczema	293.78	33.57	58	81338	0	34875535
Skin irritation	293.31	33.57	175	81221	5402	34870133
Blepharitis	291.05	33.57	114	81282	1331	34874204
Extra dose administered	289.97	33.57	155	81241	3854	34871681
Neutropenia	284.82	33.57	21	81375	156757	34718778
Rebound atopic dermatitis	278.59	33.57	55	81341	0	34875535
Dermatitis	274.38	33.57	205	81191	9263	34866272
Eyelid margin crusting	272.97	33.57	72	81324	187	34875348
Eyelids pruritus	269.46	33.57	66	81330	111	34875424
Sepsis	269.42	33.57	35	81361	166526	34709009
Eye pain	268.00	33.57	234	81162	13228	34862307
Vomiting	255.66	33.57	129	81267	247492	34628043
Eye swelling	251.52	33.57	199	81197	9796	34865739
Erythema of eyelid	249.97	33.57	91	81305	854	34874681
Nausea	248.29	33.57	256	81140	339652	34535883
Platelet count decreased	246.42	33.57	7	81389	119710	34755825
Renal failure	232.82	33.57	19	81377	130538	34744997
Eye disorder	229.72	33.57	185	81211	9343	34866192
Haemoglobin decreased	225.65	33.57	14	81382	120758	34754777
Respiratory failure	221.07	33.57	7	81389	108565	34766970
Lack of injection site rotation	219.93	33.57	60	81336	185	34875350
Injection site irritation	216.12	33.57	89	81307	1194	34874341
Asthenia	213.69	33.57	156	81240	245095	34630440
Dehydration	213.29	33.57	26	81370	129943	34745592
Confusional state	213.26	33.57	39	81357	144121	34731414
Eye inflammation	207.50	33.57	102	81294	2116	34873419
Off label use of device	205.62	33.57	45	81351	29	34875506
General physical health deterioration	202.49	33.57	29	81367	128240	34747295
Pancytopenia	201.80	33.57	4	81392	95153	34780382
Eyelid skin dryness	187.36	33.57	42	81354	35	34875500
Swelling of eyelid	186.91	33.57	77	81319	1034	34874501
Visual impairment	186.11	33.57	314	81082	35488	34840047
Abdominal pain	184.66	33.57	75	81321	163543	34711992
Completed suicide	184.50	33.57	11	81385	98157	34777378
Injection site vesicles	183.59	33.57	68	81328	673	34874862
SARS-CoV-2 test positive	182.10	33.57	133	81263	5800	34869735
Overdose	181.41	33.57	7	81389	91052	34784483
Injection site discomfort	180.98	33.57	84	81312	1526	34874009
Cardiac arrest	180.04	33.57	11	81385	96148	34779387
Fear of injection	174.54	33.57	81	81315	1471	34874064
Blood creatinine increased	174.45	33.57	12	81384	94964	34780571
Disease progression	171.57	33.57	24	81372	108053	34767482
White blood cell count decreased	167.07	33.57	15	81381	95430	34780105
Decreased appetite	165.15	33.57	91	81305	166301	34709234
Multiple organ dysfunction syndrome	163.22	33.57	3	81393	76563	34798972
Gastrointestinal haemorrhage	163.02	33.57	11	81385	88466	34787069
Constipation	162.51	33.57	58	81338	136924	34738611
Renal impairment	159.79	33.57	17	81379	94496	34781039
Fall	159.20	33.57	143	81253	202742	34672793
Alanine aminotransferase increased	152.01	33.57	9	81387	80806	34794729
Acne	150.79	33.57	156	81240	10910	34864625
Skin disorder	144.57	33.57	168	81228	13387	34862148
Ocular discomfort	144.54	33.57	79	81317	2055	34873480
Bradycardia	143.07	33.57	8	81388	75410	34800125
Wrong technique in device usage process	142.84	33.57	70	81326	1442	34874093
Skin discolouration	142.03	33.57	191	81205	17654	34857881
Oedema peripheral	141.63	33.57	51	81345	119761	34755774
Septic shock	141.46	33.57	6	81390	71828	34803707
Skin discomfort	139.81	33.57	38	81358	115	34875420
Burning sensation	139.02	33.57	192	81204	18202	34857333
Tachycardia	138.91	33.57	17	81379	84755	34790780
Cardiac failure	136.35	33.57	24	81372	91224	34784311
Eyelid irritation	133.21	33.57	35	81361	89	34875446
Hyperkalaemia	132.74	33.57	7	81389	69382	34806153
Pleural effusion	132.04	33.57	17	81379	81529	34794006
Leukopenia	131.82	33.57	3	81393	62853	34812682
Cardiac failure congestive	130.95	33.57	19	81377	83251	34792284
Atrial fibrillation	127.21	33.57	63	81333	122330	34753205
Pulmonary embolism	126.92	33.57	27	81369	89719	34785816
Seizure	126.73	33.57	43	81353	104814	34770721
Aspartate aminotransferase increased	126.11	33.57	8	81388	67775	34807760
Device defective	121.81	33.57	51	81345	715	34874820
Hypokalaemia	121.23	33.57	3	81393	58211	34817324
Rhabdomyolysis	121.21	33.57	10	81386	68153	34807382
Interstitial lung disease	120.58	33.57	8	81388	65274	34810261
Hypertension	119.65	33.57	86	81310	136357	34739178
Symptom recurrence	112.63	33.57	48	81348	705	34874830
Eye infection	111.95	33.57	82	81314	3591	34871944
Hordeolum	111.93	33.57	53	81343	1009	34874526
Weight decreased	109.91	33.57	150	81246	176151	34699384
Asthma	109.72	33.57	280	81116	42376	34833159
Rash pruritic	109.03	33.57	212	81184	26729	34848806
Hypersensitivity	108.74	33.57	351	81045	60684	34814851
Hypoxia	104.00	33.57	6	81390	55089	34820446
Deep vein thrombosis	102.31	33.57	15	81381	65233	34810302
Sneezing	102.05	33.57	90	81306	5152	34870383
Eyelid rash	101.73	33.57	24	81372	31	34875504
Neutrophil count decreased	101.50	33.57	4	81392	51100	34824435
Therapeutic response unexpected	100.83	33.57	119	81277	9638	34865897
Urticaria	98.96	33.57	345	81051	62032	34813503
Eczema eyelids	98.70	33.57	23	81373	27	34875508
Rhinorrhoea	97.85	33.57	197	81199	25471	34850064
Injection site haemorrhage	97.43	33.57	117	81279	9651	34865884
Syncope	96.62	33.57	46	81350	91405	34784130
Periorbital irritation	96.24	33.57	19	81377	0	34875535
Acute myocardial infarction	95.17	33.57	8	81388	53711	34821824
Needle issue	95.16	33.57	93	81303	6072	34869463
Ascites	94.75	33.57	3	81393	46568	34828967
Unintentional use for unapproved indication	94.59	33.57	20	81376	8	34875527
Haematuria	92.85	33.57	6	81390	50060	34825475
Anosmia	92.48	33.57	76	81320	3948	34871587
Pyrexia	91.44	33.57	432	80964	332581	34542954
Tremor	91.22	33.57	39	81357	82548	34792987
Neuropathy peripheral	90.89	33.57	40	81356	83223	34792312
Agitation	90.45	33.57	13	81383	57386	34818149
Injection site discolouration	89.47	33.57	51	81345	1442	34874093
Urinary tract infection	89.27	33.57	42	81354	84039	34791496
C-reactive protein increased	88.23	33.57	11	81385	54087	34821448
Hallucination	87.68	33.57	9	81387	51489	34824046
Nasal congestion	86.75	33.57	176	81220	22881	34852654
Hepatic function abnormal	86.35	33.57	4	81392	44359	34831176
Coma	86.14	33.57	5	81391	45673	34829862
Blood pressure increased	86.13	33.57	49	81347	88053	34787482
Drug ineffective for unapproved indication	85.66	33.57	178	81218	23537	34851998
Surgery	85.55	33.57	133	81263	14024	34861511
Blood pressure decreased	85.18	33.57	10	81386	51505	34824030
Hospitalisation	84.50	33.57	308	81088	56594	34818941
Blood creatine phosphokinase increased	84.31	33.57	5	81391	44852	34830683
Coronary artery disease	83.40	33.57	8	81388	48297	34827238
Keratitis	82.77	33.57	48	81348	1403	34874132
Pneumonia aspiration	80.85	33.57	4	81392	41899	34833636
Somnolence	80.42	33.57	84	81312	111032	34764503
Myocardial infarction	79.54	33.57	99	81297	120986	34754549
Eye allergy	78.77	33.57	20	81376	42	34875493
Hyperglycaemia	78.71	33.57	3	81393	39477	34836058
Eosinophil count increased	74.78	33.57	96	81300	8476	34867059
Oxygen saturation decreased	74.43	33.57	17	81379	53801	34821734
Blood bilirubin increased	72.80	33.57	4	81392	38292	34837243
Loss of consciousness	72.55	33.57	52	81344	82615	34792920
Plasma cell myeloma	72.47	33.57	7	81389	42030	34833505
Alopecia	72.33	33.57	169	81227	24186	34851349
Injection site dryness	72.04	33.57	17	81379	22	34875513
Scab	71.45	33.57	70	81326	4584	34870951
Intentional product use issue	71.42	33.57	25	81371	59791	34815744
Chronic kidney disease	70.68	33.57	7	81389	41203	34834332
Incorrect dose administered by device	69.45	33.57	47	81349	1811	34873724
Suicide attempt	68.81	33.57	6	81390	39110	34836425
Rectal haemorrhage	68.60	33.57	7	81389	40242	34835293
Urinary retention	68.33	33.57	4	81392	36284	34839251
Eyelid exfoliation	68.20	33.57	14	81382	3	34875532
Respiratory distress	66.95	33.57	4	81392	35661	34839874
Blood glucose increased	66.80	33.57	36	81360	66682	34808853
Pulmonary oedema	63.78	33.57	16	81380	47513	34828022
Nasopharyngitis	63.21	33.57	326	81070	69642	34805893
Sinusitis	61.36	33.57	224	81172	41178	34834357
Drug intolerance	61.33	33.57	31	81365	59539	34815996
Melaena	60.70	33.57	6	81390	35374	34840161
Cutaneous T-cell lymphoma	60.12	33.57	40	81356	1498	34874037
Blood alkaline phosphatase increased	60.06	33.57	3	81393	31172	34844363
Angioedema	59.97	33.57	8	81388	37366	34838169
Liver function test abnormal	59.84	33.57	3	81393	31071	34844464
Drug effective for unapproved indication	59.50	33.57	49	81347	2553	34872982
Dysarthria	59.41	33.57	6	81390	34776	34840759
Jaundice	58.58	33.57	4	81392	31878	34843657
Drug reaction with eosinophilia and systemic symptoms	58.24	33.57	5	81391	33007	34842528
Sensitive skin	58.20	33.57	28	81368	553	34874982
Haematochezia	58.09	33.57	18	81378	46516	34829019
Muscular weakness	57.50	33.57	51	81345	72846	34802689
Eosinophilic granulomatosis with polyangiitis	57.50	33.57	43	81353	1944	34873591
Pneumonitis	57.46	33.57	6	81390	33872	34841663
Conjunctivitis allergic	57.09	33.57	35	81361	1135	34874400
Unevaluable event	56.71	33.57	186	81210	32404	34843131
Acute respiratory failure	56.48	33.57	4	81392	30924	34844611
Gamma-glutamyltransferase increased	55.72	33.57	3	81393	29228	34846307
Cough	53.25	33.57	559	80837	149581	34725954
Foreign body sensation in eyes	52.95	33.57	27	81369	607	34874928
Oropharyngeal pain	52.59	33.57	192	81204	35293	34840242
Cerebral haemorrhage	52.57	33.57	9	81387	34928	34840607
Aggression	52.51	33.57	13	81383	38951	34836584
Keratoconus	52.17	33.57	17	81379	110	34875425
Angina pectoris	52.06	33.57	6	81390	31357	34844178
Drug-induced liver injury	51.88	33.57	4	81392	28828	34846707
Suicidal ideation	51.55	33.57	15	81381	40373	34835162
Product administered at inappropriate site	50.90	33.57	42	81354	2194	34873341
Miliaria	50.57	33.57	25	81371	525	34875010
Arrhythmia	50.13	33.57	11	81385	35797	34839738
Ventricular tachycardia	49.83	33.57	3	81393	26576	34848959
Paternal exposure during pregnancy	49.22	33.57	13	81383	34	34875501
Liver disorder	48.56	33.57	9	81387	32988	34842547
Nasal polypectomy	48.03	33.57	10	81386	3	34875532
Red blood cell count decreased	47.22	33.57	6	81390	29084	34846451
General physical condition abnormal	47.20	33.57	51	81345	3748	34871787
Treatment failure	47.03	33.57	25	81371	46672	34828863
Haematemesis	46.76	33.57	5	81391	27706	34847829
Ocular surface disease	46.66	33.57	14	81382	66	34875469
Pain of skin	46.49	33.57	64	81332	6045	34869490
Colitis	46.41	33.57	15	81381	37735	34837800
Hyposmia	46.03	33.57	18	81378	209	34875326
Hepatic enzyme increased	45.51	33.57	17	81379	39063	34836472
Drug dose omission by device	44.70	33.57	39	81357	2200	34873335
Drug dependence	44.61	33.57	3	81393	24214	34851321
Facial discomfort	44.48	33.57	12	81384	35	34875500
Chest pain	44.44	33.57	149	81247	126613	34748922
Hand-foot-and-mouth disease	44.29	33.57	14	81382	81	34875454
Pharyngitis streptococcal	44.27	33.57	42	81354	2642	34872893
Superficial injury of eye	44.23	33.57	12	81384	36	34875499
Hepatitis	43.92	33.57	3	81393	23901	34851634
Oedema	43.88	33.57	26	81370	45715	34829820
Injection site inflammation	43.62	33.57	27	81369	891	34874644
Fatigue	43.54	33.57	605	80791	370048	34505487
Injection site warmth	43.36	33.57	37	81359	2025	34873510
Haemoptysis	42.88	33.57	14	81382	34992	34840543
Knee operation	42.82	33.57	37	81359	2060	34873475
Spinal operation	42.82	33.57	43	81353	2901	34872634
Therapy non-responder	42.39	33.57	19	81377	39127	34836408
Dyspnoea exertional	42.37	33.57	24	81372	43255	34832280
Depression	42.20	33.57	103	81293	96995	34778540
Heart rate decreased	41.99	33.57	11	81385	31734	34843801
Shock	41.74	33.57	4	81392	24175	34851360
Pustule	41.58	33.57	22	81374	535	34875000
Periorbital pain	41.52	33.57	10	81386	15	34875520
Cerebral infarction	41.47	33.57	7	81389	27448	34848087
Abdominal distension	41.41	33.57	45	81351	58447	34817088
Disorientation	41.13	33.57	13	81383	33175	34842360
Injury associated with device	41.01	33.57	28	81368	1095	34874440
Rheumatoid arthritis	40.72	33.57	19	81377	38219	34837316
Dyskinesia	40.63	33.57	3	81393	22410	34853125
Cholestasis	40.41	33.57	7	81389	26941	34848594
Food allergy	40.40	33.57	31	81365	1457	34874078
Asthenopia	40.25	33.57	22	81374	572	34874963
Photophobia	40.10	33.57	64	81332	6900	34868635
Medication error	39.78	33.57	6	81390	25559	34849976
Injection site exfoliation	39.71	33.57	10	81386	20	34875515
Sinus operation	39.61	33.57	23	81373	674	34874861
Pigmentation disorder	39.52	33.57	38	81358	2431	34873104
Blister	39.35	33.57	130	81266	22728	34852807
Blood pressure systolic increased	39.09	33.57	4	81392	22948	34852587
Eczema herpeticum	39.00	33.57	15	81381	166	34875369
Altered state of consciousness	38.96	33.57	4	81392	22889	34852646
Cognitive disorder	37.84	33.57	10	81386	28683	34846852
Chills	37.60	33.57	83	81313	80960	34794575
Pulmonary hypertension	37.37	33.57	3	81393	20921	34854614
Rash maculo-papular	37.36	33.57	10	81386	28441	34847094
Musculoskeletal pain	37.06	33.57	14	81382	31949	34843586
Dyspnoea	36.77	33.57	637	80759	376145	34499390
Pancreatitis acute	36.75	33.57	10	81386	28131	34847404
Dysuria	36.70	33.57	9	81387	27143	34848392
Sinus disorder	36.59	33.57	62	81334	7023	34868512
Intestinal obstruction	36.34	33.57	5	81391	22817	34852718
Pancreatitis	36.06	33.57	23	81373	38868	34836667
Injection site discharge	35.53	33.57	15	81381	215	34875320
Product temperature excursion issue	35.50	33.57	11	81385	59	34875476
Restlessness	35.32	33.57	8	81388	25474	34850061
Dandruff	35.28	33.57	15	81381	219	34875316
Molluscum contagiosum	35.22	33.57	16	81380	276	34875259
Cholelithiasis	35.21	33.57	4	81392	21144	34854391
Quality of life decreased	35.20	33.57	45	81351	3956	34871579
Heart rate increased	34.67	33.57	34	81362	46309	34829226
Malaise	34.58	33.57	272	81124	185553	34689982
Eyelid thickening	34.51	33.57	8	81388	9	34875526
Haematoma	33.62	33.57	9	81387	25596	34849939
Laboratory test abnormal	33.60	33.57	4	81392	20387	34855148

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
Product use in unapproved indication	15124.40	25.01	7999	145856	242360	79348173
Product dose omission issue	8367.92	25.01	5446	148409	242091	79348442
Injection site pain	7295.21	25.01	3970	149885	125868	79464665
Pruritus	6044.73	25.01	5417	148438	389231	79201302
Product use issue	5947.94	25.01	4145	149710	205677	79384856
Eczema	4550.26	25.01	1997	151858	38821	79551712
Eye pruritus	4244.12	25.01	1568	152287	19002	79571531
Dry skin	4213.56	25.01	2223	151632	65772	79524761
Dry eye	4165.19	25.01	1822	152033	35109	79555424
Rash	3701.42	25.01	5024	148831	573334	79017199
Ocular hyperaemia	3086.85	25.01	1363	152492	26843	79563690
Impaired quality of life	3060.42	25.01	1122	152733	13264	79577269
Eye irritation	3024.54	25.01	1228	152627	19453	79571080
Injection site swelling	3017.68	25.01	1576	152279	45556	79544977
Skin exfoliation	2757.02	25.01	1565	152290	53535	79536998
Product dose omission in error	2723.27	25.01	881	152974	6907	79583626
Conjunctivitis	2383.66	25.01	1107	152748	24608	79565925
Injection site erythema	2352.48	25.01	1607	152248	76590	79513943
Inappropriate schedule of product administration	2301.43	25.01	1969	151886	131659	79458874
COVID-19	2095.16	25.01	2008	151847	155666	79434867
Sleep disorder	1860.72	25.01	1446	152409	84231	79506302
Incorrect dose administered	1826.18	25.01	1367	152488	75263	79515270
Injection site rash	1651.37	25.01	769	153086	17185	79573348
Therapeutic response shortened	1417.28	25.01	666	153189	15197	79575336
Injection site pruritus	1409.87	25.01	927	152928	41356	79549177
Skin fissures	1346.88	25.01	606	153249	12467	79578066
Therapeutic response decreased	1256.20	25.01	1037	152818	65816	79524717
Product preparation error	1239.55	25.01	454	153401	5339	79585194
Injection site urticaria	1168.93	25.01	546	153309	12280	79578253
Injection site reaction	1150.43	25.01	907	152948	53878	79536655
Accidental exposure to product	1133.28	25.01	723	153132	30599	79559934
Product prescribing issue	1062.14	25.01	369	153486	3676	79586857
Skin burning sensation	1045.07	25.01	511	153344	12761	79577772
Rash macular	1003.29	25.01	650	153205	28249	79562284
Erythema	1000.06	25.01	1649	152206	221641	79368892
Vision blurred	941.83	25.01	1090	152765	104808	79485725
Acute kidney injury	931.51	25.01	14	153841	519390	79071143
Lacrimation increased	901.52	25.01	554	153301	21923	79568610
Injection site bruising	869.63	25.01	683	153172	40319	79550214
Oral herpes	838.12	25.01	570	153285	26884	79563649
Product storage error	808.12	25.01	460	153395	15766	79574767
Toxicity to various agents	784.97	25.01	5	153850	421535	79168998
Rash erythematous	762.22	25.01	734	153121	57035	79533498
Skin haemorrhage	707.40	25.01	380	153475	11601	79578932
Illness	704.13	25.01	638	153217	45873	79544660
Drug ineffective	699.49	25.01	3995	149860	1076918	78513615
Device use issue	696.50	25.01	245	153610	2539	79587994
Anaemia	689.02	25.01	43	153812	444972	79145561
Condition aggravated	687.05	25.01	2324	151531	498800	79091733
Eye discharge	683.42	25.01	299	153556	5735	79584798
Discomfort	665.84	25.01	1003	152852	124614	79465919
Dermatitis atopic	653.36	25.01	340	153515	9716	79580817
Drug interaction	640.05	25.01	41	153814	415142	79175391
Diarrhoea	636.30	25.01	465	153390	880024	78710509
Eye pain	603.48	25.01	533	153322	37045	79553488
Hypotension	599.34	25.01	73	153782	440244	79150289
Skin swelling	598.88	25.01	242	153613	3772	79586761
Injection site mass	575.79	25.01	402	153453	19782	79570751
Intentional dose omission	561.08	25.01	294	153561	8523	79582010
Death	547.48	25.01	205	153650	566309	79024224
Eye swelling	537.72	25.01	430	153425	26038	79564495
Vomiting	535.59	25.01	311	153544	665517	78925016
Arthralgia	534.60	25.01	2349	151506	569454	79021079
SARS-CoV-2 test positive	524.59	25.01	310	153545	11406	79579127
Blepharitis	499.56	25.01	198	153657	2926	79587607
Skin weeping	493.91	25.01	149	153706	898	79589635
Eyelids pruritus	490.22	25.01	145	153710	808	79589725
Drug effect less than expected	481.91	25.01	173	153682	1911	79588622
Nausea	480.86	25.01	691	153164	956505	78634028
Extra dose administered	480.31	25.01	261	153594	8154	79582379
Rebound eczema	477.46	25.01	92	153763	6	79590527
Injection site irritation	475.82	25.01	202	153653	3588	79586945
Eyelid margin crusting	470.87	25.01	144	153711	915	79589618
Thrombocytopenia	463.25	25.01	10	153845	265249	79325284
Erythema of eyelid	460.84	25.01	177	153678	2393	79588140
Neutropenia	444.37	25.01	28	153827	287682	79302851
Rebound atopic dermatitis	433.56	25.01	88	153767	34	79590499
Eye disorder	428.58	25.01	358	153497	23054	79567479
Febrile neutropenia	428.31	25.01	3	153852	230996	79359537
Periorbital swelling	423.12	25.01	172	153683	2724	79587809
Completed suicide	422.47	25.01	11	153844	245756	79344777
Drug intolerance	406.98	25.01	26	153829	264093	79326440
Scratch	397.41	25.01	230	153625	8133	79582400
Swelling of eyelid	396.68	25.01	178	153677	3633	79586900
Dermatitis	394.38	25.01	328	153527	20993	79569540
Infusion related reaction	389.48	25.01	12	153843	230225	79360308
Injection site dryness	389.24	25.01	99	153756	274	79590259
Confusional state	383.96	25.01	74	153781	317923	79272610
Skin irritation	375.73	25.01	247	153608	10993	79579540
Haemoglobin decreased	367.21	25.01	14	153841	222105	79368428
Asthenia	358.57	25.01	278	153577	511411	79079122
General physical health deterioration	352.06	25.01	55	153800	275183	79315350
Abdominal pain	348.34	25.01	158	153697	389411	79201122
Sepsis	337.53	25.01	57	153798	269371	79321162
Pneumonia	336.34	25.01	471	153384	659775	78930758
Eye inflammation	330.58	25.01	186	153669	6227	79584306
Off label use of device	327.28	25.01	87	153768	302	79590231
Hyponatraemia	321.70	25.01	4	153851	177844	79412689
Platelet count decreased	319.28	25.01	13	153842	194651	79395882
Visual impairment	316.83	25.01	607	153248	91524	79499009
Wrong technique in device usage process	304.83	25.01	151	153704	3877	79586656
Pancytopenia	298.58	25.01	4	153851	165741	79424792
Drug abuse	297.25	25.01	3	153852	162688	79427845
Overdose	293.30	25.01	15	153840	184191	79406342
Decreased appetite	292.09	25.01	148	153707	342270	79248263
White blood cell count decreased	288.60	25.01	19	153836	188269	79402264
Renal failure	283.96	25.01	29	153826	200939	79389594
Hospitalisation	278.65	25.01	583	153272	93653	79496880
Dehydration	274.78	25.01	70	153785	248117	79342416
Alanine aminotransferase increased	269.50	25.01	10	153845	162560	79427973
Respiratory failure	266.58	25.01	22	153833	180889	79409644
Eyelid skin dryness	264.56	25.01	65	153790	148	79590385
Hepatic enzyme increased	261.53	25.01	25	153830	182585	79407948
Lack of injection site rotation	258.28	25.01	78	153777	472	79590061
Injection site exfoliation	257.84	25.01	68	153787	227	79590306
Cardiac arrest	256.16	25.01	20	153835	172076	79418457
Synovitis	254.33	25.01	8	153847	150726	79439807
Hypokalaemia	253.06	25.01	5	153850	144035	79446498
Constipation	252.55	25.01	115	153740	282935	79307598
Blood creatinine increased	248.84	25.01	12	153843	155045	79435488
Oedema peripheral	245.35	25.01	90	153765	252198	79338335
Injection site discomfort	245.25	25.01	142	153713	5024	79585509
Contraindicated product administered	244.09	25.01	15	153840	157523	79433010
Hordeolum	241.11	25.01	120	153735	3113	79587420
Hypertension	240.37	25.01	173	153682	330819	79259714
Rheumatoid arthritis	240.18	25.01	54	153801	208416	79382117
Fall	239.96	25.01	356	153499	487273	79103260
Eyelid irritation	232.14	25.01	69	153786	392	79590141
Fear of injection	229.96	25.01	156	153699	7318	79583215
Unevaluable event	227.51	25.01	395	153460	55190	79535343
Surgery	227.45	25.01	298	153557	32468	79558065
Eyelid rash	226.41	25.01	55	153800	117	79590416
Ocular discomfort	226.07	25.01	133	153722	4850	79585683
Aspartate aminotransferase increased	224.84	25.01	10	153845	138631	79451902
Disease progression	222.16	25.01	43	153812	184319	79406214
Bradycardia	219.10	25.01	10	153845	135547	79454986
Gastrointestinal haemorrhage	217.52	25.01	18	153837	147701	79442832
Renal impairment	217.19	25.01	25	153830	157758	79432775
Injection site discolouration	215.60	25.01	151	153704	7463	79583070
Tachycardia	213.07	25.01	42	153813	177726	79412807
Multiple organ dysfunction syndrome	207.98	25.01	5	153850	120241	79470292
Treatment failure	204.92	25.01	40	153815	170446	79420087
Injection site vesicles	202.78	25.01	105	153750	2967	79587566
Blood pressure increased	201.13	25.01	78	153777	211282	79379251
Needle issue	201.07	25.01	181	153674	12887	79577646
Pleural effusion	199.97	25.01	23	153832	145239	79445294
Septic shock	198.66	25.01	9	153846	122792	79467741
Pulmonary embolism	198.64	25.01	44	153811	171610	79418923
Leukopenia	197.21	25.01	6	153849	116507	79474026
Injection site haemorrhage	195.82	25.01	255	153600	27615	79562918
Rash pruritic	195.43	25.01	429	153426	71200	79519333
Urticaria	191.55	25.01	786	153069	184415	79406118
Hyperkalaemia	189.71	25.01	7	153848	114391	79476142
Cardiac failure	188.92	25.01	35	153820	154807	79435726
Intentional overdose	188.90	25.01	3	153852	105957	79484576
Skin discolouration	187.05	25.01	306	153549	40728	79549805
Burning sensation	186.57	25.01	374	153481	58258	79532275
Interstitial lung disease	179.73	25.01	9	153846	112591	79477942
Intentional product use issue	178.01	25.01	38	153817	152074	79438459
Weight decreased	176.84	25.01	257	153598	354941	79235592
Seizure	174.25	25.01	73	153782	188761	79401772
C-reactive protein increased	171.33	25.01	23	153832	129004	79461529
Eye infection	169.55	25.01	158	153697	11762	79578771
Atrial fibrillation	169.39	25.01	85	153770	197801	79392732
Hypoglycaemia	169.21	25.01	6	153849	101588	79488945
Neutrophil count decreased	166.08	25.01	3	153852	93956	79496577
Cardiac failure congestive	163.75	25.01	37	153818	142365	79448168
Depressed level of consciousness	163.49	25.01	5	153850	96647	79493886
Periorbital irritation	162.83	25.01	31	153824	0	79590533
Coma	160.79	25.01	8	153847	100641	79489892
Lower respiratory tract infection	160.25	25.01	28	153827	129192	79461341
Arthropathy	157.82	25.01	72	153783	177039	79413494
Somnolence	155.74	25.01	139	153716	238842	79351691
Rhabdomyolysis	150.62	25.01	13	153842	103118	79487415
Eosinophilic granulomatosis with polyangiitis	148.70	25.01	91	153764	3569	79586964
Deep vein thrombosis	148.21	25.01	27	153828	120892	79469641
Pain of skin	147.76	25.01	161	153694	14452	79576081
Injection site warmth	147.75	25.01	162	153693	14645	79575888
Eyelid exfoliation	147.14	25.01	38	153817	114	79590419
Skin discomfort	146.04	25.01	55	153800	702	79589831
Pyrexia	145.34	25.01	745	153110	677964	78912569
Unintentional use for unapproved indication	143.63	25.01	41	153814	197	79590336
Device defective	142.39	25.01	71	153784	1849	79588684
Pericarditis	139.78	25.01	18	153837	104218	79486315
Systemic lupus erythematosus	138.24	25.01	32	153823	121117	79469416
Sensitive skin	138.22	25.01	68	153787	1719	79588814
Hypoxia	138.03	25.01	18	153837	103225	79487308
Agitation	136.70	25.01	16	153839	99699	79490834
Glossodynia	135.82	25.01	19	153836	103318	79487215
Skin disorder	134.70	25.01	238	153617	33705	79556828
General physical condition abnormal	131.92	25.01	106	153749	6457	79584076
Ascites	131.20	25.01	3	153852	75559	79514974
Acne	131.06	25.01	208	153647	26982	79563551
Eosinophil count increased	128.80	25.01	162	153693	16943	79573590
Suicide attempt	128.11	25.01	8	153847	82924	79507609
Hepatic function abnormal	126.56	25.01	3	153852	73104	79517429
Fatigue	125.52	25.01	1169	152686	928558	78661975
Eczema eyelids	124.75	25.01	35	153820	156	79590377
Oxygen saturation decreased	118.84	25.01	50	153805	128997	79461536
Syncope	118.54	25.01	103	153752	179346	79411187
Urinary tract infection	118.43	25.01	218	153637	274294	79316239
Drug hypersensitivity	117.26	25.01	251	153604	298665	79291868
Tremor	116.81	25.01	94	153761	169989	79420544
Eye allergy	115.90	25.01	46	153809	682	79589851
Cough	115.71	25.01	1148	152707	365641	79224892
Malaise	115.02	25.01	520	153335	489349	79101184
Rash papular	114.49	25.01	174	153681	21742	79568791
Blood creatine phosphokinase increased	113.31	25.01	3	153852	66087	79524446
Asthma	109.89	25.01	534	153321	134561	79455972
Stomatitis	108.65	25.01	75	153780	146682	79443851
Therapy non-responder	108.09	25.01	23	153832	92282	79498251
Pneumonia aspiration	107.99	25.01	5	153850	66962	79523571
Incorrect dose administered by device	107.62	25.01	84	153771	4905	79585628
Hallucination	107.58	25.01	18	153837	85727	79504806
Myocardial infarction	107.38	25.01	118	153737	184011	79406522
Musculoskeletal pain	107.33	25.01	32	153823	102322	79488211
Acute myocardial infarction	106.49	25.01	12	153843	77024	79513509
Oedema	105.90	25.01	49	153806	119531	79471002
Mobility decreased	105.24	25.01	52	153803	122123	79468410
Blood pressure fluctuation	105.16	25.01	6	153849	67139	79523394
Hyperglycaemia	105.11	25.01	8	153847	70327	79520206
Medication error	104.90	25.01	7	153848	68635	79521898
Blood pressure systolic increased	104.87	25.01	6	153849	66980	79523553
Oropharyngeal pain	103.56	25.01	452	153403	108901	79481632
Rectal haemorrhage	102.72	25.01	13	153842	76287	79514246
Therapeutic response unexpected	102.28	25.01	157	153698	19789	79570744
Injection site eczema	102.03	25.01	25	153830	56	79590477
Foreign body sensation in eyes	101.62	25.01	59	153796	2098	79588435
Joint swelling	101.45	25.01	257	153598	288389	79302144
Helicobacter infection	101.20	25.01	9	153846	69695	79520838
Liver disorder	100.81	25.01	11	153844	72406	79518127
Hepatic failure	100.60	25.01	4	153851	61208	79529325
Conjunctivitis allergic	99.96	25.01	54	153801	1666	79588867
Haematuria	99.63	25.01	9	153846	68827	79521706
Coronary artery disease	99.12	25.01	7	153848	65467	79525066
Haematochezia	98.31	25.01	24	153831	87621	79502912
Blood cholesterol increased	97.75	25.01	21	153834	83699	79506834
Wound	97.74	25.01	51	153804	116128	79474405
Respiratory arrest	97.24	25.01	3	153852	57547	79532986
Melaena	96.74	25.01	5	153850	60885	79529648
Cognitive disorder	96.39	25.01	11	153844	69915	79520618
Drug ineffective for unapproved indication	96.24	25.01	266	153589	50972	79539561
Impaired healing	94.50	25.01	26	153829	87629	79502904
Unresponsive to stimuli	93.93	25.01	3	153852	55785	79534748
Quality of life decreased	93.70	25.01	108	153747	10312	79580221
Blood alkaline phosphatase increased	93.02	25.01	8	153847	63656	79526877
Injection site inflammation	92.46	25.01	70	153785	3906	79586627
Anosmia	92.15	25.01	99	153756	8745	79581788
Pulmonary oedema	91.79	25.01	28	153827	88226	79502307
Drug reaction with eosinophilia and systemic symptoms	91.39	25.01	9	153846	64235	79526298
Abdominal discomfort	90.63	25.01	220	153635	250507	79340026
Hepatitis	90.39	25.01	4	153851	55723	79534810
Chronic kidney disease	89.72	25.01	11	153844	66143	79524390
Jaundice	89.36	25.01	3	153852	53346	79537187
Middle insomnia	88.82	25.01	131	153724	15938	79574595
Gamma-glutamyltransferase increased	88.44	25.01	4	153851	54676	79535857
Heart rate decreased	87.68	25.01	15	153840	70301	79520232
Symptom recurrence	87.59	25.01	55	153800	2259	79588274
Eosinophilic pneumonia	86.56	25.01	76	153779	5234	79585299
Neuropathy peripheral	86.37	25.01	87	153768	141218	79449315
Scab	85.84	25.01	104	153751	10468	79580065
Plasma cell myeloma	85.80	25.01	4	153851	53255	79537278
Perioral dermatitis	85.65	25.01	31	153824	351	79590182
Suicidal ideation	85.43	25.01	21	153834	76319	79514214
Keratitis	85.16	25.01	69	153786	4253	79586280
Orthostatic hypotension	85.03	25.01	6	153849	56158	79534375
Intercepted product storage error	84.81	25.01	28	153827	235	79590298
Blood pressure decreased	84.66	25.01	43	153812	99423	79491110
Sneezing	84.62	25.01	143	153712	19540	79570993
Drug dose omission by device	83.45	25.01	80	153775	6170	79584363
Muscular weakness	83.15	25.01	113	153742	160616	79429917
Transaminases increased	82.99	25.01	4	153851	51739	79538794
Acute respiratory failure	82.99	25.01	9	153846	59532	79531001
Loss of consciousness	82.99	25.01	122	153733	167821	79422712
Pneumonitis	82.83	25.01	10	153845	60850	79529683
Cutaneous T-cell lymphoma	82.16	25.01	56	153799	2647	79587886
Red blood cell count decreased	81.96	25.01	8	153847	57505	79533028
Injury	81.66	25.01	24	153831	77472	79513061
Blood urea increased	80.82	25.01	3	153852	48787	79541746
Psoriatic arthropathy	80.66	25.01	25	153830	77974	79512559
Asthenopia	80.29	25.01	53	153802	2374	79588159
Osteoarthritis	78.51	25.01	35	153820	87274	79503259
Dizziness	77.35	25.01	647	153208	525794	79064739
Muscle injury	77.10	25.01	4	153851	48557	79541976
Chest pain	76.60	25.01	283	153572	282021	79308512
Respiratory distress	76.01	25.01	11	153844	58328	79532205
Blood glucose increased	75.90	25.01	66	153789	114909	79475624
Urinary retention	75.38	25.01	10	153845	56620	79533913
Cholestasis	74.91	25.01	7	153848	52102	79538431
Injury associated with device	73.40	25.01	58	153797	3448	79587085
Dysarthria	73.00	25.01	20	153835	67602	79522931
Haematemesis	72.59	25.01	8	153847	52256	79538277
Irritable bowel syndrome	71.87	25.01	16	153839	62225	79528308
Product administered at inappropriate site	69.19	25.01	59	153796	3906	79586627
Sunburn	68.86	25.01	58	153797	3775	79586758
Generalised tonic-clonic seizure	68.53	25.01	4	153851	43906	79546627
Periorbital pain	68.21	25.01	19	153836	82	79590451
Ventricular tachycardia	68.04	25.01	3	153852	41932	79548601
Hypothyroidism	67.98	25.01	10	153845	52382	79538151
Back pain	67.68	25.01	329	153526	303851	79286682
Gastrointestinal disorder	67.25	25.01	82	153773	122123	79468410
Disorientation	66.96	25.01	19	153836	62757	79527776
Colitis	66.52	25.01	29	153826	73278	79517255
Cerebral haemorrhage	66.24	25.01	15	153840	57658	79532875
Dysphagia	66.11	25.01	83	153772	122053	79468480
Drug dependence	65.88	25.01	3	153852	40766	79549767
Acute respiratory distress syndrome	65.87	25.01	5	153850	44062	79546471
Hypophagia	65.47	25.01	6	153849	45361	79545172
Musculoskeletal stiffness	65.25	25.01	151	153704	174857	79415676
Multiple sclerosis relapse	64.94	25.01	7	153848	46526	79544007
Ocular surface disease	64.51	25.01	19	153836	104	79590429
Dyskinesia	64.40	25.01	6	153849	44767	79545766
Psychotic disorder	63.92	25.01	4	153851	41398	79549135
Upper gastrointestinal haemorrhage	63.88	25.01	4	153851	41376	79549157
Periorbital inflammation	63.84	25.01	18	153837	82	79590451
Hypervolaemia	63.38	25.01	5	153850	42685	79547848
Blood lactate dehydrogenase increased	62.91	25.01	3	153852	39167	79551366
Altered state of consciousness	62.70	25.01	6	153849	43816	79546717
Angina pectoris	62.41	25.01	12	153843	51720	79538813
Depression	62.34	25.01	212	153643	216578	79373955
Shock	62.20	25.01	6	153849	43542	79546991
Cholelithiasis	61.90	25.01	13	153842	52651	79537882
Type 2 diabetes mellitus	61.46	25.01	17	153838	57105	79533428
Red blood cell sedimentation rate increased	61.42	25.01	8	153847	45934	79544599
Aggression	61.10	25.01	12	153843	50946	79539587
Arrhythmia	60.96	25.01	21	153834	61251	79529282
Rhinorrhoea	60.60	25.01	299	153556	75775	79514758
Pulmonary hypertension	60.51	25.01	10	153845	48070	79542463
Pigmentation disorder	60.50	25.01	64	153791	5554	79584979
Eyelid thickening	60.31	25.01	16	153839	55	79590478
Sinus operation	59.92	25.01	45	153810	2480	79588053
Dyspnoea exertional	59.91	25.01	48	153807	87025	79503508
Dyspnoea	59.86	25.01	1231	152624	855794	78734739
Skin depigmentation	59.40	25.01	33	153822	1077	79589456
Heart rate increased	59.33	25.01	88	153767	120636	79469897
Fibromyalgia	59.10	25.01	25	153830	64315	79526218
Hyposmia	58.84	25.01	29	153826	736	79589797
Pancreatitis acute	58.81	25.01	12	153843	49592	79540941
Product temperature excursion issue	58.49	25.01	21	153834	232	79590301
Nasal polypectomy	58.34	25.01	13	153842	15	79590518
Palpitations	56.84	25.01	98	153757	126512	79464021
Folliculitis	56.82	25.01	18	153837	55362	79535171
Facial discomfort	56.27	25.01	17	153838	103	79590430
Pulmonary fibrosis	55.91	25.01	9	153846	44103	79546430
Pallor	55.57	25.01	14	153841	50048	79540485
Obesity	55.43	25.01	3	153852	35122	79555411
Drug effective for unapproved indication	55.31	25.01	63	153792	5938	79584595
Superficial injury of eye	55.24	25.01	19	153836	183	79590350
Gait disturbance	54.97	25.01	210	153645	207296	79383237
Sleep disorder due to general medical condition, insomnia type	54.95	25.01	9	153846	43547	79546986
Angioedema	54.76	25.01	40	153815	75995	79514538
Rash maculo-papular	54.46	25.01	20	153835	56058	79534475
Full blood count abnormal	54.22	25.01	7	153848	40467	79550066
Sinus tachycardia	52.94	25.01	5	153850	36903	79553630
Balance disorder	52.65	25.01	68	153787	98789	79491744
Skin texture abnormal	52.18	25.01	23	153832	449	79590084
Pancreatitis	52.14	25.01	34	153821	68541	79521992
Nasal congestion	52.09	25.01	288	153567	76264	79514269
Ejection fraction decreased	51.47	25.01	4	153851	34573	79555960
Knee operation	51.41	25.01	60	153795	5806	79584727
Coagulopathy	51.33	25.01	5	153850	36001	79554532
Hallucination, visual	51.02	25.01	3	153852	32726	79557807
Dyspepsia	50.76	25.01	82	153773	108605	79481928
Epilepsy	50.32	25.01	9	153846	40851	79549682
Hand dermatitis	49.92	25.01	21	153834	364	79590169
Osteoporosis	49.75	25.01	21	153834	54091	79536442
Photophobia	49.36	25.01	117	153738	20411	79570122
Abdominal distension	48.94	25.01	98	153757	119552	79470981
Subdural haematoma	48.64	25.01	3	153852	31431	79559102
Liver function test increased	48.46	25.01	9	153846	39764	79550769
Cerebral infarction	48.39	25.01	14	153841	45662	79544871
Bacteraemia	48.29	25.01	4	153851	32820	79557713
Dysuria	48.09	25.01	19	153836	50932	79539601
Anxiety	47.92	25.01	282	153573	248230	79342303
Skin mass	47.87	25.01	68	153787	7995	79582538
Stevens-Johnson syndrome	47.43	25.01	9	153846	39157	79551376
Clostridium difficile colitis	47.32	25.01	4	153851	32279	79558254
Tachypnoea	46.92	25.01	4	153851	32059	79558474
Keratoconus	46.73	25.01	15	153840	114	79590419
Myelodysplastic syndrome	46.56	25.01	3	153852	30298	79560235
Haemoptysis	46.47	25.01	25	153830	55974	79534559
Joint range of motion decreased	46.46	25.01	5	153850	33277	79557256
Blood pressure diastolic decreased	46.41	25.01	3	153852	30213	79560320
Injection site extravasation	45.26	25.01	73	153782	9596	79580937
Osteonecrosis	45.17	25.01	4	153851	31091	79559442
Pneumocystis jirovecii pneumonia	45.08	25.01	5	153850	32503	79558030
Aphasia	44.82	25.01	17	153838	46715	79543818
Electrolyte imbalance	44.79	25.01	4	153851	30877	79559656
Blood potassium increased	44.69	25.01	3	153852	29272	79561261
Device dispensing error	44.51	25.01	15	153840	135	79590398
Spinal operation	44.42	25.01	65	153790	7852	79582681
Miliaria	43.85	25.01	31	153824	1555	79588978
Gastrooesophageal reflux disease	43.83	25.01	84	153771	104162	79486371
Amnesia	43.08	25.01	35	153820	63022	79527511
Emotional distress	42.80	25.01	12	153843	39957	79550576
Upper-airway cough syndrome	42.58	25.01	79	153776	11614	79578919
Intentional self-injury	42.49	25.01	6	153849	32413	79558120
Lethargy	42.18	25.01	57	153798	81235	79509298
Clostridium difficile infection	41.82	25.01	15	153840	42670	79547863
Cellulitis	41.53	25.01	93	153762	108967	79481566
Blood potassium decreased	41.26	25.01	19	153836	46493	79544040
Hepatic steatosis	41.03	25.01	11	153844	37727	79552806
Small intestinal obstruction	41.03	25.01	3	153852	27269	79563264
Drainage	40.97	25.01	14	153841	132	79590401
Circulatory collapse	40.92	25.01	11	153844	37657	79552876
Pericardial effusion	40.84	25.01	19	153836	46218	79544315
Urinary incontinence	40.73	25.01	14	153841	40895	79549638
Femur fracture	40.66	25.01	12	153843	38640	79551893
Basal cell carcinoma	40.44	25.01	11	153844	37364	79553169
Pulmonary arterial hypertension	40.27	25.01	4	153851	28362	79562171
Metastases to liver	40.18	25.01	4	153851	28310	79562223
White blood cell count increased	40.09	25.01	51	153804	74582	79515951
Restlessness	39.70	25.01	20	153835	46472	79544061
Dandruff	39.51	25.01	18	153837	381	79590152
Throat clearing	39.33	25.01	36	153819	2618	79587915
Product administered to patient of inappropriate age	39.29	25.01	51	153804	5502	79585031
Adverse event	39.20	25.01	35	153820	60179	79530354
Dysgeusia	38.73	25.01	32	153823	57145	79533388
Product quality issue	38.63	25.01	9	153846	33931	79556602
Proteinuria	38.25	25.01	8	153847	32494	79558039
Skin erosion	38.18	25.01	45	153810	4400	79586133
Hepatic cytolysis	38.10	25.01	4	153851	27147	79563386
Cerebrovascular accident	38.06	25.01	162	153693	155130	79435403
Body temperature decreased	37.65	25.01	8	153847	32137	79558396
Chills	37.55	25.01	170	153685	160064	79430469
Frequent bowel movements	37.49	25.01	6	153849	29533	79561000
Injection site discharge	37.44	25.01	22	153833	800	79589733
Eczema herpeticum	37.28	25.01	16	153839	292	79590241
Injection site indentation	37.22	25.01	14	153841	178	79590355
Rosacea	37.11	25.01	43	153812	4129	79586404
Abnormal behaviour	37.07	25.01	12	153843	36409	79554124
Ataxia	36.98	25.01	3	153852	25036	79565497
Gastroenteritis	36.93	25.01	10	153845	34072	79556461
Haematoma	36.88	25.01	28	153827	52167	79538366
Osteomyelitis	36.85	25.01	9	153846	32856	79557677
Haemorrhoids	36.78	25.01	6	153849	29122	79561411
Diabetes mellitus	35.80	25.01	60	153795	78330	79512203
Maternal exposure during pregnancy	35.62	25.01	139	153716	136399	79454134
No adverse event	35.38	25.01	154	153701	37038	79553495
Swelling face	35.31	25.01	247	153608	70965	79519568
Body temperature increased	35.18	25.01	21	153834	44399	79546134
Neutrophil count increased	35.08	25.01	7	153848	29389	79561144
Full blood count decreased	35.07	25.01	5	153850	26814	79563719
Abdominal pain lower	35.06	25.01	9	153846	31773	79558760
Lymphopenia	34.99	25.01	8	153847	30549	79559984
Paranasal sinus discomfort	34.82	25.01	43	153812	4413	79586120
Lack of administration site rotation	34.60	25.01	9	153846	28	79590505
Cyanosis	34.60	25.01	4	153851	25178	79565355
Intestinal obstruction	34.55	25.01	20	153835	43000	79547533
Haemorrhage	34.45	25.01	78	153777	91040	79499493
Ear discomfort	33.81	25.01	60	153795	8523	79582010
Leukocytosis	33.78	25.01	21	153834	43434	79547099
Incorrect route of product administration	33.51	25.01	145	153710	34784	79555749
Treatment noncompliance	33.29	25.01	31	153824	52237	79538296
Fluid retention	33.22	25.01	52	153803	69757	79520776
Mental disorder	33.21	25.01	134	153721	31168	79559365
Lymphocytic infiltration	33.18	25.01	26	153829	1527	79589006
Molluscum contagiosum	33.10	25.01	17	153838	472	79590061
Iron deficiency anaemia	33.07	25.01	5	153850	25667	79564866
Diabetes mellitus inadequate control	32.98	25.01	4	153851	24260	79566273
Bursitis	32.80	25.01	14	153841	35830	79554703
Glomerular filtration rate decreased	32.76	25.01	3	153852	22699	79567834
Respiration abnormal	32.70	25.01	56	153799	7732	79582801
Hand-foot-and-mouth disease	32.69	25.01	15	153840	323	79590210
Accidental overdose	32.36	25.01	18	153837	39563	79550970
Sinus disorder	32.15	25.01	106	153749	22358	79568175
Injection site scar	32.03	25.01	20	153835	813	79589720
Cholecystitis	31.88	25.01	3	153852	22209	79568324
Eyelid pain	31.86	25.01	15	153840	343	79590190
Ischaemic stroke	31.86	25.01	12	153843	33119	79557414
Pharyngeal swelling	31.75	25.01	55	153800	7664	79582869
Therapy interrupted	31.54	25.01	132	153723	31209	79559324
Injection site hypoaesthesia	31.39	25.01	17	153838	527	79590006
Pustule	31.05	25.01	28	153827	1997	79588536
Chromaturia	31.00	25.01	6	153849	25740	79564793
Atrial flutter	30.83	25.01	3	153852	21622	79568911
Disease recurrence	30.74	25.01	24	153831	44085	79546448
Device operational issue	30.57	25.01	15	153840	377	79590156
Cystitis	30.49	25.01	34	153821	52698	79537835
Ill-defined disorder	30.47	25.01	50	153805	65825	79524708
Polyneuropathy	30.44	25.01	5	153850	24146	79566387
Rebound effect	30.40	25.01	52	153803	7174	79583359
Hypoalbuminaemia	30.24	25.01	3	153852	21294	79569239
Disturbance in attention	30.21	25.01	32	153823	50769	79539764
Urosepsis	30.21	25.01	7	153848	26488	79564045
Cardiomyopathy	30.15	25.01	9	153846	28765	79561768
Anaphylactic shock	29.97	25.01	16	153839	35980	79554553
Cardiomegaly	29.97	25.01	7	153848	26345	79564188
Blepharospasm	29.92	25.01	46	153809	5805	79584728
Sudden death	29.90	25.01	4	153851	22507	79568026
Hepatic cirrhosis	29.83	25.01	15	153840	34891	79555642
Oral candidiasis	29.74	25.01	10	153845	29618	79560915
Red blood cell sedimentation rate abnormal	29.65	25.01	3	153852	20960	79569573
Atopic keratoconjunctivitis	29.61	25.01	8	153847	30	79590503
Lung disorder	29.61	25.01	70	153785	80487	79510046
Emergency care	29.53	25.01	21	153834	1063	79589470
Pneumothorax	29.42	25.01	9	153846	28314	79562219
Eosinophilic pneumonia chronic	29.37	25.01	16	153839	502	79590031
Obstructive airways disorder	29.25	25.01	12	153843	31447	79559086
SARS-CoV-1 test positive	29.21	25.01	8	153847	32	79590501
Nightmare	29.15	25.01	7	153848	25854	79564679
Increased viscosity of upper respiratory secretion	29.08	25.01	14	153841	337	79590196
Dermatitis exfoliative generalised	29.01	25.01	51	153804	7190	79583343
Lip erythema	28.98	25.01	13	153842	265	79590268
Cutaneous T-cell lymphoma stage IV	28.82	25.01	8	153847	34	79590499
Injection site nodule	28.77	25.01	36	153819	3744	79586789
Muscle spasticity	28.09	25.01	4	153851	21471	79569062
Dystonia	27.95	25.01	4	153851	21395	79569138
Muscle rigidity	27.72	25.01	3	153852	19879	79570654
Herpes ophthalmic	27.48	25.01	23	153832	1484	79589049
Transient ischaemic attack	27.28	25.01	37	153818	52658	79537875
Chronic obstructive pulmonary disease	27.01	25.01	80	153775	85339	79505194
Gastric ulcer	26.89	25.01	16	153839	33889	79556644
Splenomegaly	26.83	25.01	4	153851	20750	79569783
Left ventricular dysfunction	26.79	25.01	3	153852	19358	79571175
Pharyngitis streptococcal	26.78	25.01	62	153793	10652	79579881
Hemiparesis	26.64	25.01	16	153839	33717	79556816
Night sweats	26.55	25.01	37	153818	52058	79538475
Heart rate irregular	26.52	25.01	15	153840	32664	79557869
Conjunctival papillae	26.26	25.01	5	153850	0	79590533
Foot deformity	26.21	25.01	7	153848	24067	79566466
Pyelonephritis	26.20	25.01	4	153851	20384	79570149
Cutaneous T-cell lymphoma stage III	26.18	25.01	7	153848	25	79590508
Asymptomatic COVID-19	26.02	25.01	13	153842	340	79590193
Hypereosinophilic syndrome	25.84	25.01	15	153840	533	79590000
Toothache	25.75	25.01	91	153764	19879	79570654
Thrombosis	25.71	25.01	80	153775	84020	79506513
Laboratory test abnormal	25.60	25.01	11	153844	28037	79562496
Platelet count increased	25.39	25.01	6	153849	22400	79568133
Withdrawal syndrome	25.37	25.01	10	153845	26844	79563689
Acute coronary syndrome	25.28	25.01	5	153850	21128	79569405
Intercepted product dispensing error	25.03	25.01	10	153845	151	79590382

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	D11AH05	DERMATOLOGICALS OTHER DERMATOLOGICAL PREPARATIONS OTHER DERMATOLOGICAL PREPARATIONS Agents for dermatitis, excluding corticosteroids
FDA CS	M0001357	Antibodies, Monoclonal
FDA MoA	N0000193341	Interleukin 4 Receptor alpha Antagonists
FDA EPC	N0000193342	Interleukin-4 Receptor alpha Antagonist

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

Disease	Relation	SNOMED_ID	DOID
Atopic dermatitis	indication	24079001	DOID:3310
Chronic sinusitis	indication	40055000
Prurigo nodularis	indication	63501000
Asthma	indication	195967001	DOID:2841
Eosinophilic esophagitis	indication	235599003	DOID:13922

🐶 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-4 receptor subunit alpha	Membrane receptor	P24394	IL4RA_HUMAN	ANTIBODY BINDING	IC50	11.06		IUPHAR	DRUG LABEL

External reference:

ID	Source
420K487FSG	UNII
4036554	VANDF
C3660996	UMLSCUI
CHEMBL2108675	ChEMBL_ID
DB12159	DRUGBANK_ID
D10354	KEGG_DRUG
9669	INN_ID
7574	IUPHAR_LIGAND_ID
255128	MMSL
32580	MMSL
d08549	MMSL
017152	NDDF
733487000	SNOMEDCT_US
763589007	SNOMEDCT_US
1876376	RXNORM
C582203	MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5911	INJECTION, SOLUTION	100 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5911	INJECTION, SOLUTION	100 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5911	INJECTION, SOLUTION	100 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5911	INJECTION, SOLUTION	100 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5914	INJECTION, SOLUTION	300 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5914	INJECTION, SOLUTION	300 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5914	INJECTION, SOLUTION	300 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5914	INJECTION, SOLUTION	300 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5915	INJECTION, SOLUTION	300 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5915	INJECTION, SOLUTION	300 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5915	INJECTION, SOLUTION	300 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5915	INJECTION, SOLUTION	300 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5916	INJECTION, SOLUTION	300 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5918	INJECTION, SOLUTION	200 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5918	INJECTION, SOLUTION	200 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5918	INJECTION, SOLUTION	200 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5918	INJECTION, SOLUTION	200 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5919	INJECTION, SOLUTION	200 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5919	INJECTION, SOLUTION	200 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5919	INJECTION, SOLUTION	200 mg	SUBCUTANEOUS	BLA	31 sections
Dupixent	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5919	INJECTION, SOLUTION	200 mg	SUBCUTANEOUS	BLA	31 sections