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

Stem definition	Drug id	CAS RN
steroids for topical use, acetal derivatives	419	51333-22-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: budesonide barazone budesomide budeson	A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS. Molecular weight: 430.54 Formula: C25H34O6 CLOGP: 2.90 LIPINSKI: 0 HAC: 6 HDO: 2 TPSA: 93.06 ALOGS: -3.97 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

budesonide
barazone
budesomide
budeson

A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.

Molecular weight: 430.54
Formula: C25H34O6
CLOGP: 2.90
LIPINSKI: 0
HAC: 6
HDO: 2
TPSA: 93.06
ALOGS: -3.97
ROTB: 4

Status: OFP

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

Drug dosage:

Dose	Unit	Route
9	mg	O
2	mg	SL
0.20	mg	N
0.80	mg	Inhal.aerosol
0.80	mg	Inhal.powder
1.50	mg	Inhal.solution

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.02 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.04 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	37 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	3.90 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	20 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.13 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	2.80 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company
Feb. 14, 1994	FDA
June 18, 2019	PMDA	AstraZeneca K.K.
Aug. 1, 2018	EMA	Dr. Falk Pharma GmbH

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Asthma	1811.75	9.92	1345	80314	87992	50435473
Wheezing	692.39	9.92	663	80996	61384	50462081
Dyspnoea	557.87	9.92	2039	79620	545569	49977896
Obstructive airways disorder	533.65	9.92	326	81333	15326	50508139
Cough	315.24	9.92	979	80680	240285	50283180
Chest discomfort	269.54	9.92	513	81146	92209	50431256
Sleep disorder due to a general medical condition	227.10	9.92	144	81515	7227	50516238
Full blood count abnormal	202.26	9.92	218	81441	23170	50500295
Macular degeneration	195.80	9.92	172	81487	14216	50509249
Eosinophil count increased	189.69	9.92	138	81521	8692	50514773
Eosinophilic bronchitis	184.18	9.92	56	81603	427	50523038
Contraindicated product administered	173.45	9.92	19	81640	148939	50374526
Systemic lupus erythematosus	171.44	9.92	15	81644	140607	50382858
Chronic obstructive pulmonary disease	154.35	9.92	295	81364	53140	50470325
Completed suicide	143.41	9.92	21	81638	131868	50391597
Hand deformity	143.04	9.92	4	81655	100195	50423270
Chronic sinusitis	136.47	9.92	98	81561	6047	50517418
Toxicity to various agents	134.25	9.92	89	81570	212410	50311055
Colitis ulcerative	133.42	9.92	150	81509	16704	50506761
Pneumonia	133.19	9.92	1054	80605	377347	50146118
Nasal polyps	132.41	9.92	70	81589	2484	50520981
Respiratory symptom	130.38	9.92	68	81591	2346	50521119
Alopecia	123.49	9.92	128	81531	244919	50278546
Arthropathy	120.42	9.92	52	81607	157854	50365611
Productive cough	120.33	9.92	264	81395	52430	50471035
Synovitis	115.07	9.92	29	81630	123836	50399629
Gastrooesophageal reflux disease	112.53	9.92	324	81335	76104	50447361
Asthmatic crisis	111.89	9.92	54	81605	1574	50521891
Blood test abnormal	109.43	9.92	112	81547	11207	50512258
Glossodynia	109.42	9.92	26	81633	115543	50407922
Treatment failure	105.45	9.92	45	81614	137592	50385873
Sputum discoloured	103.95	9.92	118	81541	13277	50510188
Forced expiratory volume decreased	99.70	9.92	71	81588	4323	50519142
Upper-airway cough syndrome	98.30	9.92	93	81566	8457	50515008
Polyp	97.50	9.92	77	81582	5485	50517980
Pericarditis	96.95	9.92	8	81651	78681	50444784
Rheumatoid arthritis	92.00	9.92	115	81544	202435	50321030
Swelling	90.24	9.92	115	81544	200757	50322708
Labile blood pressure	87.48	9.92	46	81613	1614	50521851
Pain	86.92	9.92	563	81096	578340	49945125
Polycystic ovaries	85.29	9.92	52	81607	2432	50521033
Bronchospasm	84.69	9.92	112	81547	14742	50508723
Middle insomnia	83.18	9.92	91	81568	9830	50513635
Febrile neutropenia	83.07	9.92	27	81632	97640	50425825
Neutrophilia	79.35	9.92	57	81602	3518	50519947
Joint swelling	78.28	9.92	175	81484	245111	50278354
Blood immunoglobulin E increased	77.47	9.92	48	81611	2311	50521154
Bronchial secretion retention	77.11	9.92	41	81618	1472	50521993
Abdominal discomfort	76.62	9.92	162	81497	231479	50291986
Sleep apnoea syndrome	71.64	9.92	134	81525	23734	50499731
Heart rate increased	71.39	9.92	280	81379	76970	50446495
Rhinitis allergic	70.98	9.92	72	81587	7128	50516337
Eosinophilic granulomatosis with polyangiitis	69.89	9.92	42	81617	1913	50521552
Growth failure	67.93	9.92	24	81635	306	50523159
Reversible airways obstruction	67.59	9.92	33	81626	987	50522478
Anaphylactic reaction	66.29	9.92	215	81444	53840	50469625
Wound	65.81	9.92	45	81614	105749	50417716
Hepatic enzyme increased	65.53	9.92	75	81584	137305	50386160
Sinusitis fungal	65.46	9.92	35	81624	1271	50522194
Drug intolerance	63.03	9.92	165	81494	218939	50304526
White blood cell count decreased	62.14	9.92	58	81601	116664	50406801
Sensitisation	61.83	9.92	36	81623	1546	50521919
Vital capacity decreased	60.58	9.92	30	81629	926	50522539
Loss of personal independence in daily activities	60.01	9.92	248	81411	69802	50453663
Drug abuse	59.59	9.92	12	81647	59834	50463631
Dyspnoea exertional	59.44	9.92	200	81459	51033	50472432
Hyper IgE syndrome	58.01	9.92	23	81636	411	50523054
Upper respiratory fungal infection	57.59	9.92	18	81641	152	50523313
Dysphonia	57.32	9.92	165	81494	38727	50484738
Impaired healing	56.39	9.92	21	81638	69765	50453700
Sputum increased	56.32	9.92	36	81623	1831	50521634
Bronchiectasis	56.27	9.92	76	81583	10207	50513258
Respiratory tract infection	54.30	9.92	143	81516	31874	50491591
Intentional overdose	53.63	9.92	17	81642	62487	50460978
Frequent bowel movements	53.30	9.92	87	81572	13831	50509634
Embolism venous	53.18	9.92	39	81620	2486	50520979
Salpingo-oophorectomy unilateral	53.12	9.92	23	81636	518	50522947
Nasal congestion	52.77	9.92	192	81467	50928	50472537
Neutropenia	51.85	9.92	100	81559	147865	50375600
Rheumatoid factor positive	51.77	9.92	9	81650	49850	50473615
Thrombocytopenia	50.44	9.92	80	81579	127593	50395872
Lung diffusion test abnormal	49.43	9.92	16	81643	153	50523312
Circumstance or information capable of leading to medication error	49.26	9.92	41	81618	3147	50520318
Peak expiratory flow rate decreased	48.11	9.92	22	81637	566	50522899
Emphysema	47.93	9.92	66	81593	9027	50514438
Ventricular failure	47.44	9.92	19	81640	349	50523116
Sputum culture positive	47.02	9.92	29	81630	1385	50522080
Platelet count decreased	46.94	9.92	56	81603	100670	50422795
Hypothyroidism	46.68	9.92	141	81518	33984	50489481
Stomatitis	46.53	9.92	57	81602	101287	50422178
Eosinophilia	45.47	9.92	96	81563	18556	50504909
Butterfly rash	45.35	9.92	27	81632	1209	50522256
Death	44.89	9.92	324	81335	325055	50198410
Peripheral swelling	44.60	9.92	176	81483	205760	50317705
Hepatic ischaemia	44.42	9.92	21	81638	584	50522881
Therapeutic product effect decreased	44.22	9.92	96	81563	135954	50387511
Ejection fraction	43.47	9.92	26	81633	1174	50522291
Bronchitis	43.16	9.92	302	81357	103857	50419608
Therapeutic product effect incomplete	43.14	9.92	274	81385	91241	50432224
Malignant neoplasm progression	42.33	9.92	29	81630	68095	50455370
Intestinal stenosis	42.04	9.92	34	81625	2506	50520959
Aspergillus infection	41.32	9.92	53	81606	6768	50516697
Pancytopenia	41.01	9.92	45	81614	83985	50439480
Female genital tract fistula	40.48	9.92	39	81620	3627	50519838
Graft versus host disease in gastrointestinal tract	39.35	9.92	34	81625	2747	50520718
Infective pulmonary exacerbation of cystic fibrosis	38.12	9.92	55	81604	7854	50515611
Systemic mycosis	37.75	9.92	23	81636	1074	50522391
Throat irritation	37.71	9.92	121	81538	30118	50493347
Sinusitis	37.24	9.92	430	81229	170128	50353337
Sinus disorder	37.14	9.92	88	81571	18370	50505095
Restrictive pulmonary disease	36.97	9.92	25	81634	1399	50522066
Hepatorenal syndrome	36.88	9.92	27	81632	1716	50521749
Infusion related reaction	36.64	9.92	145	81514	169412	50354053
Bacterial infection	36.49	9.92	81	81578	16200	50507265
Breath sounds abnormal	35.83	9.92	53	81606	7739	50515726
Bulimia nervosa	35.75	9.92	16	81643	391	50523074
Intentional device misuse	35.66	9.92	19	81640	685	50522780
Discomfort	35.61	9.92	76	81583	108304	50415161
Acute kidney injury	35.48	9.92	219	81440	227839	50295626
Blister	35.19	9.92	52	81607	85366	50438099
Hip arthroplasty	35.08	9.92	4	81655	30425	50493040
Anosmia	34.60	9.92	37	81622	3894	50519571
Abdominal pain	34.50	9.92	554	81105	235674	50287791
Respiratory tract inflammation	34.38	9.92	17	81642	523	50522942
Vocal cord dysfunction	34.19	9.92	15	81644	349	50523116
Venous pressure jugular increased	34.11	9.92	17	81642	532	50522933
Ileal stenosis	33.89	9.92	24	81635	1448	50522017
Blood pressure increased	33.84	9.92	346	81313	132786	50390679
Pulmonary function test decreased	33.61	9.92	34	81625	3354	50520111
Therapeutic reaction time decreased	33.36	9.92	23	81636	1329	50522136
Muscle relaxant therapy	33.21	9.92	12	81647	164	50523301
Fall	32.78	9.92	364	81295	334568	50188897
Herpes simplex oesophagitis	32.77	9.92	11	81648	119	50523346
Oropharyngeal pain	32.47	9.92	226	81433	77575	50445890
Eczema	32.18	9.92	95	81564	22607	50500858
Adrenal suppression	31.86	9.92	19	81640	853	50522612
Oropharyngeal discomfort	31.67	9.92	35	81624	3823	50519642
Cystic fibrosis	30.74	9.92	30	81629	2834	50520631
Rash	30.36	9.92	510	81149	436961	50086504
Rhonchi	30.22	9.92	27	81632	2280	50521185
Upper respiratory tract infection	29.63	9.92	195	81464	65703	50457762
Frustration tolerance decreased	29.63	9.92	41	81618	5633	50517832
Total lung capacity decreased	29.61	9.92	21	81638	1270	50522195
Bronchopulmonary aspergillosis allergic	28.77	9.92	20	81639	1171	50522294
Gastrointestinal wall thickening	28.20	9.92	19	81640	1057	50522408
Hiatus hernia	28.17	9.92	79	81580	18265	50505200
Intestinal obstruction	27.99	9.92	100	81559	26283	50497182
Weight decreased	27.98	9.92	507	81152	220738	50302727
Blood cholesterol increased	27.57	9.92	29	81630	55186	50468279
Off label use	27.35	9.92	978	80681	473448	50050017
Drug specific antibody	27.22	9.92	23	81636	1802	50521663
Decreased appetite	27.21	9.92	201	81458	200722	50322743
Bronchomalacia	27.03	9.92	11	81648	211	50523254
Neutrophil count decreased	26.76	9.92	21	81638	46005	50477460
Hypotension	26.69	9.92	247	81412	235222	50288243
Rhinorrhoea	26.53	9.92	158	81501	51425	50472040
Respiratory distress	26.14	9.92	108	81551	30381	50493084
Cushingoid	26.07	9.92	42	81617	6603	50516862
Laryngeal stenosis	25.62	9.92	16	81643	781	50522684
Infective exacerbation of chronic obstructive airways disease	25.36	9.92	18	81641	1090	50522375
Dust allergy	25.22	9.92	14	81645	548	50522917
Eosinophilic oesophagitis	25.15	9.92	11	81648	254	50523211
Bronchial obstruction	25.10	9.92	19	81640	1271	50522194
Coma	25.05	9.92	33	81626	56846	50466619
Status asthmaticus	24.97	9.92	16	81643	817	50522648
Superinfection	24.85	9.92	23	81636	2033	50521432
Multiple allergies	24.75	9.92	47	81612	8416	50515049
Disease progression	24.72	9.92	76	81583	95790	50427675
Palpitations	24.66	9.92	247	81412	94259	50429206
Bone marrow failure	24.63	9.92	7	81652	27617	50495848
Sleep disorder due to general medical condition, insomnia type	24.51	9.92	10	81649	31437	50492028
Multiple sclerosis relapse	24.48	9.92	20	81639	42944	50480521
Device expulsion	24.44	9.92	8	81651	28814	50494651
Obstruction	24.34	9.92	23	81636	2088	50521377
Diastolic dysfunction	24.29	9.92	36	81623	5266	50518199
Psoriatic arthropathy	24.28	9.92	24	81635	47008	50476457
Graft versus host disease in skin	24.18	9.92	25	81634	2531	50520934
Ascites	24.01	9.92	14	81645	35847	50487618
Intestinal resection	23.93	9.92	24	81635	2343	50521122
Respiration abnormal	23.89	9.92	35	81624	5067	50518398
Mobility decreased	23.88	9.92	59	81600	79889	50443576
Pseudomonas infection	23.53	9.92	49	81610	9381	50514084
Aphonia	23.47	9.92	46	81613	8432	50515033
Respiratory disorder	23.31	9.92	106	81553	31081	50492384
Arthritis enteropathic	23.27	9.92	10	81649	221	50523244
Infusion site extravasation	23.26	9.92	41	81618	6935	50516530
Somnolence	22.97	9.92	151	81508	154834	50368631
Pouchitis	22.93	9.92	12	81647	417	50523048
Periorbital oedema	22.92	9.92	34	81625	4978	50518487
Lung disorder	22.90	9.92	137	81522	44662	50478803
Drug hypersensitivity	22.89	9.92	277	81382	250733	50272732
Sputum purulent	22.86	9.92	16	81643	947	50522518
Confusional state	22.84	9.92	191	81468	185737	50337728
Obstructive pancreatitis	22.82	9.92	10	81649	232	50523233
Irritable bowel syndrome	22.49	9.92	30	81629	51411	50472054
Pharyngeal hypoaesthesia	22.43	9.92	10	81649	242	50523223
Intentional self-injury	22.25	9.92	5	81654	23107	50500358
Haemoptysis	22.25	9.92	91	81568	25482	50497983
Nausea	21.85	9.92	924	80735	704474	49818991
Overdose	21.71	9.92	85	81574	99642	50423823
Increased upper airway secretion	21.56	9.92	26	81633	3118	50520347
Adrenal insufficiency	21.54	9.92	61	81598	14182	50509283
Candida infection	21.50	9.92	85	81574	23438	50500027
Crohn's disease	21.49	9.92	32	81627	4701	50518764
C-reactive protein abnormal	21.42	9.92	9	81650	27800	50495665
Swollen tongue	21.17	9.92	97	81562	28533	50494932
Sensitivity to weather change	20.96	9.92	36	81623	5965	50517500
Product quality issue	20.95	9.92	102	81557	30756	50492709
Asphyxia	20.88	9.92	34	81625	5393	50518072
Diverticulum	20.70	9.92	50	81609	10564	50512901
Bacterial disease carrier	20.49	9.92	14	81645	797	50522668
Throat tightness	20.42	9.92	77	81582	20770	50502695
Nasal discharge discolouration	20.39	9.92	18	81641	1496	50521969
Device malfunction	20.23	9.92	62	81597	15059	50508406
Maternal exposure during pregnancy	20.14	9.92	163	81496	159615	50363850
Neoplasm progression	20.07	9.92	11	81648	29146	50494319
Alternaria infection	19.96	9.92	9	81650	224	50523241
Haematochezia	19.77	9.92	121	81538	39761	50483704
Musculoskeletal stiffness	19.63	9.92	124	81535	128357	50395108
Drug level below therapeutic	19.49	9.92	27	81632	3713	50519752
Osteomyelitis	19.31	9.92	6	81653	22347	50501118
Kyphosis	19.15	9.92	21	81638	2274	50521191
Sedation	19.05	9.92	13	81646	30597	50492868
Diarrhoea	19.01	9.92	767	80892	587709	49935756
Mitochondrial neurogastrointestinal encephalopathy	18.96	9.92	4	81655	4	50523461
Oesophageal candidiasis	18.83	9.92	31	81628	4963	50518502
Catarrh	18.76	9.92	10	81649	361	50523104
Pharyngeal oedema	18.57	9.92	55	81604	13110	50510355
Ligament pain	18.40	9.92	8	81651	182	50523283
Vomiting	18.40	9.92	585	81074	460173	50063292
Rales	18.40	9.92	46	81613	9932	50513533
Malaise	18.39	9.92	688	80971	334844	50188621
Cardio-respiratory arrest	18.36	9.92	37	81622	53855	50469610
Rhinitis	18.27	9.92	41	81618	8260	50515205
Rectal prolapse	18.18	9.92	18	81641	1731	50521734
Sprue-like enteropathy	18.09	9.92	11	81648	512	50522953
Tracheostomy infection	18.07	9.92	5	81654	26	50523439
Suicide attempt	18.07	9.92	35	81624	51697	50471768
Cognitive disorder	18.03	9.92	27	81632	44096	50479369
Type IV hypersensitivity reaction	17.80	9.92	21	81638	2461	50521004
Acquired diaphragmatic eventration	17.80	9.92	10	81649	401	50523064
Tachycardia	17.67	9.92	242	81417	99521	50423944
Nocturnal dyspnoea	17.67	9.92	14	81645	1002	50522463
Colitis microscopic	17.59	9.92	35	81624	6485	50516980
Sinus congestion	17.50	9.92	56	81603	13915	50509550
Fatigue	17.14	9.92	951	80708	706650	49816815
Lip infection	17.09	9.92	6	81653	75	50523390
Otorrhoea	17.05	9.92	15	81644	1241	50522224
Impaired quality of life	16.94	9.92	33	81626	6023	50517442
Anaemia	16.92	9.92	296	81363	252160	50271305
Secretion discharge	16.87	9.92	44	81615	9747	50513718
Sinus operation	16.79	9.92	17	81642	1679	50521786
Faecal calprotectin increased	16.74	9.92	19	81640	2136	50521329
Gastrointestinal disorder	16.66	9.92	87	81572	94369	50429096
Smoke sensitivity	16.65	9.92	9	81650	334	50523131
Encephalopathy	16.50	9.92	18	81641	33693	50489772
Pulmonary function test abnormal	16.50	9.92	15	81644	1296	50522169
Hyperplastic cholecystopathy	16.47	9.92	6	81653	84	50523381
Female reproductive neoplasm	16.46	9.92	5	81654	38	50523427
Oligoarthritis	16.42	9.92	8	81651	238	50523227
Haemoglobin decreased	16.39	9.92	129	81530	127087	50396378
Metastases to liver	16.32	9.92	6	81653	20098	50503367
Blood immunoglobulin G decreased	16.28	9.92	18	81641	1967	50521498
Viral infection	16.16	9.92	93	81566	29893	50493572
Increased bronchial secretion	16.09	9.92	16	81643	1546	50521919
Small intestinal stenosis	16.05	9.92	10	81649	486	50522979
Dyslipidaemia	15.99	9.92	32	81627	5956	50517509
Mucosal inflammation	15.98	9.92	25	81634	40117	50483348
Incorrect dose administered	15.91	9.92	133	81526	48281	50475184
Pulmonary mass	15.83	9.92	66	81593	18639	50504826
Leukopenia	15.71	9.92	56	81603	67472	50455993
Throat clearing	15.65	9.92	14	81645	1184	50522281
Nasal oedema	15.65	9.92	12	81647	818	50522647
Dyspnoea at rest	15.62	9.92	24	81635	3623	50519842
Terminal insomnia	15.62	9.92	11	81648	658	50522807
Eczema impetiginous	15.52	9.92	4	81655	15	50523450
Tremor	15.46	9.92	266	81393	114637	50408828
Tachypnoea	15.25	9.92	55	81604	14522	50508943
Cryptosporidiosis infection	15.18	9.92	8	81651	282	50523183
Aspirin-exacerbated respiratory disease	15.10	9.92	12	81647	862	50522603
Endometriosis	14.97	9.92	25	81634	4050	50519415
Abdominal rigidity	14.93	9.92	16	81643	1688	50521777
Cytomegalovirus infection	14.90	9.92	63	81596	17899	50505566
Post viral fatigue syndrome	14.87	9.92	8	81651	294	50523171
Red blood cell sedimentation rate abnormal	14.83	9.92	4	81655	16339	50507126
Liver injury	14.83	9.92	11	81648	24795	50498670
Laryngeal oedema	14.70	9.92	28	81631	5025	50518440
Lung opacity	14.66	9.92	17	81642	1956	50521509
Hypocalcaemia	14.64	9.92	13	81646	26803	50496662
Anal fistula	14.60	9.92	20	81639	2722	50520743
Infection	14.58	9.92	194	81465	172760	50350705
Defaecation urgency	14.48	9.92	21	81638	3012	50520453
Aspiration	14.32	9.92	40	81619	9224	50514241
Coprolalia	14.27	9.92	4	81655	22	50523443
Rectal tenesmus	14.27	9.92	9	81650	447	50523018
Weight gain poor	14.27	9.92	11	81648	756	50522709
Graft versus host disease	14.18	9.92	31	81628	6135	50517330
Hysterectomy	14.15	9.92	36	81623	7854	50515611
Cardiac disorder	14.08	9.92	118	81541	42861	50480604
Atopy	13.93	9.92	7	81652	223	50523242
Abscess intestinal	13.86	9.92	14	81645	1379	50522086
Stridor	13.78	9.92	21	81638	3148	50520317
Mucous stools	13.72	9.92	20	81639	2882	50520583
Cushing's syndrome	13.63	9.92	10	81649	638	50522827
Metastases to bone	13.58	9.92	6	81653	17989	50505476
Pulmonary artery stenosis congenital	13.49	9.92	7	81652	239	50523226
Oedema peripheral	13.48	9.92	342	81317	157619	50365846
Distal intestinal obstruction syndrome	13.46	9.92	8	81651	357	50523108
Nephrectomy	13.45	9.92	11	81648	824	50522641
Norovirus infection	13.43	9.92	7	81652	241	50523224
Abscess	13.39	9.92	52	81607	14220	50509245
Bronchospasm paradoxical	13.35	9.92	5	81654	76	50523389
Device ineffective	13.24	9.92	6	81653	151	50523314
Weight fluctuation	13.23	9.92	33	81626	7115	50516350
Myelodysplastic syndrome	13.18	9.92	4	81655	15128	50508337
Large intestinal stenosis	13.07	9.92	15	81644	1707	50521758
Haematemesis	13.04	9.92	83	81576	27642	50495823
Plasma cell myeloma	12.96	9.92	19	81640	31303	50492162
Device failure	12.95	9.92	28	81631	5500	50517965
Generalised tonic-clonic seizure	12.93	9.92	14	81645	26296	50497169
Tooth disorder	12.93	9.92	12	81647	24216	50499249
Growth retardation	12.92	9.92	12	81647	1066	50522399
Infrapatellar fat pad inflammation	12.89	9.92	6	81653	161	50523304
Drug specific antibody present	12.82	9.92	21	81638	3347	50520118
Bowel movement irregularity	12.82	9.92	23	81636	3945	50519520
Respiratory rate increased	12.81	9.92	44	81615	11341	50512124
Knee arthroplasty	12.74	9.92	24	81635	35822	50487643
Respiratory tract congestion	12.73	9.92	51	81608	14148	50509317
Paraesthesia oral	12.69	9.92	46	81613	12175	50511290
Skin dystrophy	12.57	9.92	4	81655	36	50523429
Bronchitis bacterial	12.53	9.92	10	81649	723	50522742
Hypersensitivity pneumonitis	12.46	9.92	17	81642	2305	50521160
Ageusia	12.37	9.92	44	81615	11539	50511926
Faeces soft	12.34	9.92	23	81636	4061	50519404
Small intestinal obstruction	12.29	9.92	55	81604	16013	50507452
Congenital naevus	12.27	9.92	6	81653	180	50523285
Congenital tricuspid valve incompetence	12.23	9.92	5	81654	97	50523368
Delayed puberty	12.19	9.92	5	81654	98	50523367
Gingival hypertrophy	12.12	9.92	13	81646	1373	50522092
Infusion site swelling	12.11	9.92	32	81627	7144	50516321
Aural polyp	12.09	9.92	5	81654	100	50523365
Disease recurrence	11.97	9.92	64	81595	20017	50503448
Injection site reaction	11.96	9.92	41	81618	49991	50473474
Perfume sensitivity	11.93	9.92	9	81650	599	50522866
Intestinal fistula	11.91	9.92	10	81649	777	50522688
Pallor	11.89	9.92	71	81588	23128	50500337
Clostridium difficile infection	11.87	9.92	76	81583	25363	50498102
Bronchial hyperreactivity	11.84	9.92	13	81646	1409	50522056
Myalgia	11.76	9.92	273	81386	124046	50399419
Renal impairment	11.56	9.92	73	81586	75588	50447877
Sputum culture	11.53	9.92	5	81654	113	50523352
Blood pressure systolic	11.47	9.92	4	81655	49	50523416
Arrhythmia	11.41	9.92	92	81567	33040	50490425
Ear pruritus	11.35	9.92	17	81642	2509	50520956
Allergy to animal	11.34	9.92	10	81649	830	50522635
Sinus pain	11.30	9.92	16	81643	2245	50521220
Diabetes mellitus	11.30	9.92	125	81534	48908	50474557
Photosensitivity reaction	11.27	9.92	46	81613	12865	50510600
Product taste abnormal	11.27	9.92	14	81645	1731	50521734
Hyponatraemia	11.24	9.92	100	81559	96039	50427426
Product use in unapproved indication	11.16	9.92	255	81404	115564	50407901
Condition aggravated	11.14	9.92	586	81073	296472	50226993
Collateral circulation	11.11	9.92	3	81656	14	50523451
Steroid dependence	11.09	9.92	7	81652	348	50523117
Type 2 diabetes mellitus	11.06	9.92	94	81565	34281	50489184
Adenovirus infection	11.06	9.92	19	81640	3149	50520316
Anal abscess	11.02	9.92	21	81638	3770	50519695
Sacroiliitis	11.00	9.92	17	81642	2580	50520885
Language disorder	11.00	9.92	14	81645	1774	50521691
Kussmaul respiration	10.97	9.92	6	81653	228	50523237
Mitochondrial cytopathy	10.95	9.92	6	81653	229	50523236
Urinary tract discomfort	10.95	9.92	6	81653	229	50523236
Gastrointestinal scarring	10.92	9.92	6	81653	230	50523235
Granulomatosis with polyangiitis	10.92	9.92	14	81645	1786	50521679
Drug level decreased	10.89	9.92	29	81630	6504	50516961
Red blood cell count decreased	10.88	9.92	24	81635	33811	50489654
Hepatotoxicity	10.80	9.92	17	81642	27209	50496256
Incorrect route of product administration	10.79	9.92	59	81600	18607	50504858
Pulmonary contusion	10.78	9.92	3	81656	16	50523449
Left ventricular failure	10.75	9.92	24	81635	4817	50518648
Feeling jittery	10.74	9.92	41	81618	11119	50512346
Bronchial wall thickening	10.70	9.92	10	81649	895	50522570
Behaviour disorder	10.67	9.92	16	81643	2364	50521101
Symptom recurrence	10.65	9.92	9	81650	705	50522760
Type I hypersensitivity	10.65	9.92	16	81643	2369	50521096
Tongue blistering	10.60	9.92	12	81647	1346	50522119
Drug withdrawal syndrome	10.59	9.92	15	81644	25066	50498399
Nasal discomfort	10.59	9.92	21	81638	3883	50519582
Tendon pain	10.58	9.92	18	81641	2960	50520505
Skin atrophy	10.52	9.92	22	81637	4223	50519242
Stenotrophomonas test positive	10.48	9.92	3	81656	18	50523447
Laryngitis fungal	10.48	9.92	5	81654	142	50523323
Hyperglycaemia	10.40	9.92	97	81562	36308	50487157
Forced vital capacity decreased	10.37	9.92	10	81649	931	50522534
Bone erosion	10.35	9.92	3	81656	11684	50511781
Herpes zoster oticus	10.34	9.92	6	81653	256	50523209
Cryptococcal meningoencephalitis	10.33	9.92	4	81655	67	50523398
Blood glucose increased	10.30	9.92	70	81589	71254	50452211
Functional residual capacity decreased	10.27	9.92	4	81655	68	50523397
Dermatitis contact	10.24	9.92	34	81625	8612	50514853
Depressed level of consciousness	10.23	9.92	46	81613	51907	50471558
Rash maculo-papular	10.22	9.92	17	81642	26624	50496841
Cyanosis	10.17	9.92	50	81609	15134	50508331
Faeces discoloured	10.03	9.92	52	81607	16072	50507393
Tricuspid valve incompetence	9.99	9.92	44	81615	12726	50510739
Chest pain	9.98	9.92	364	81295	176518	50346947
Cross sensitivity reaction	9.94	9.92	14	81645	1955	50521510

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Asthma	694.56	10.24	506	45429	33343	29495249
Wheezing	316.18	10.24	320	45615	32920	29495672
Dyspnoea	279.86	10.24	1122	44813	325610	29202982
Cough	192.03	10.24	529	45406	126198	29402394
Productive cough	130.52	10.24	199	45736	31060	29497532
Colitis ulcerative	128.78	10.24	127	45808	12642	29515950
Chronic obstructive pulmonary disease	126.96	10.24	228	45707	40727	29487865
Toxicity to various agents	126.19	10.24	56	45879	173605	29354987
Chest discomfort	122.62	10.24	240	45695	45743	29482849
Frequent bowel movements	116.42	10.24	104	45831	9135	29519457
Growth failure	108.54	10.24	24	45911	38	29528554
Completed suicide	101.36	10.24	11	45924	90235	29438357
Drug abuse	94.29	10.24	8	45927	79875	29448717
Eosinophilic granulomatosis with polyangiitis	90.94	10.24	44	45891	1342	29527250
Acute kidney injury	89.52	10.24	173	45762	265094	29263498
Bronchiectasis	80.74	10.24	73	45862	6512	29522080
Condition aggravated	77.16	10.24	438	45497	145857	29382735
Night sweats	76.83	10.24	105	45830	14827	29513765
Cushingoid	75.18	10.24	47	45888	2391	29526201
Adrenal suppression	75.02	10.24	29	45906	503	29528089
Therapeutic product effect incomplete	72.61	10.24	177	45758	39128	29489464
Sleep disorder due to a general medical condition	71.19	10.24	50	45885	3096	29525496
Bronchospasm	69.29	10.24	80	45855	9529	29519063
Loss of personal independence in daily activities	66.82	10.24	132	45803	25308	29503284
Blood immunoglobulin E increased	66.33	10.24	40	45895	1907	29526685
Faecal calprotectin increased	63.56	10.24	36	45899	1525	29527067
Spirometry abnormal	62.02	10.24	23	45912	354	29528238
Nasal polyps	61.97	10.24	37	45898	1732	29526860
Colitis	59.08	10.24	142	45793	31106	29497486
Mycotic allergy	58.16	10.24	20	45915	244	29528348
Death	57.59	10.24	305	45630	341779	29186813
Weight decreased	55.12	10.24	412	45523	150493	29378099
Ileal stenosis	54.56	10.24	30	45905	1199	29527393
Dust allergy	52.82	10.24	22	45913	467	29528125
Mite allergy	47.28	10.24	18	45917	299	29528293
Cushing's syndrome	46.57	10.24	19	45916	382	29528210
Circumstance or information capable of leading to medication error	46.04	10.24	29	45906	1495	29527097
Full blood count abnormal	44.47	10.24	82	45853	14931	29513661
Impaired quality of life	44.41	10.24	35	45900	2584	29526008
Mucous stools	43.03	10.24	25	45910	1112	29527480
Off label use	42.93	10.24	680	45255	300120	29228472
Sinusitis	42.83	10.24	134	45801	34216	29494376
Neutropenia	42.49	10.24	88	45847	131623	29396969
Breath sounds abnormal	42	10.24	47	45888	5410	29523182
Bronchiolitis	40.76	10.24	34	45901	2721	29525871
Conjunctivitis allergic	40.74	10.24	20	45915	630	29527962
Product use issue	40.64	10.24	173	45762	51271	29477321
Obstructive airways disorder	40.24	10.24	66	45869	10950	29517642
Lung diffusion test decreased	39.62	10.24	19	45916	568	29528024
Proctitis	39.60	10.24	30	45905	2089	29526503
Herpes zoster meningoencephalitis	39.02	10.24	15	45920	256	29528336
Dyspnoea at rest	38.17	10.24	35	45900	3179	29525413
Steroid dependence	37.64	10.24	15	45920	283	29528309
Aphthous ulcer	36.51	10.24	38	45897	4030	29524562
Febrile neutropenia	34.51	10.24	77	45858	112163	29416429
Blood immunoglobulin E decreased	34.22	10.24	9	45926	39	29528553
Cyanosis	33.95	10.24	62	45873	11205	29517387
Adrenal insufficiency	32.03	10.24	60	45875	11054	29517538
Graft versus host disease	31.60	10.24	55	45880	9573	29519019
Asphyxia	31.39	10.24	40	45895	5275	29523317
Infective pulmonary exacerbation of cystic fibrosis	30.79	10.24	43	45892	6193	29522399
Pneumonia	30.76	10.24	681	45254	319491	29209101
Nasal congestion	30.66	10.24	81	45854	18798	29509794
Sputum discoloured	30.55	10.24	44	45891	6519	29522073
Eye swelling	30.45	10.24	51	45884	8606	29519986
Intentional device misuse	30.17	10.24	11	45924	161	29528431
Disease progression	29.67	10.24	51	45884	81865	29446727
Heart rate increased	28.50	10.24	128	45807	38810	29489782
Forced expiratory volume decreased	28.39	10.24	28	45907	2785	29525807
Mycobacterium test positive	27.50	10.24	13	45922	376	29528216
Intestinal fistula	27.33	10.24	17	45918	857	29527735
Respiratory tract infection	27.32	10.24	69	45866	15582	29513010
Upper-airway cough syndrome	26.85	10.24	28	45907	2975	29525617
Colitis microscopic	26.58	10.24	22	45913	1741	29526851
Therapeutic product effect decreased	26.38	10.24	103	45832	29348	29499244
Lung disorder	26.24	10.24	105	45830	30257	29498335
Nasal obstruction	25.94	10.24	14	45921	539	29528053
Neuropathy peripheral	25.92	10.24	44	45891	70983	29457609
Allergy to animal	25.76	10.24	11	45924	249	29528343
Foetal distress syndrome	25.25	10.24	17	45918	982	29527610
Delayed puberty	25.13	10.24	10	45925	188	29528404
Thrombocytopenia	24.39	10.24	117	45818	134706	29393886
Musculoskeletal stiffness	24.26	10.24	14	45921	37444	29491148
Procedural pneumothorax	24.18	10.24	7	45928	46	29528546
Intentional overdose	24.11	10.24	15	45920	38513	29490079
Lower respiratory tract infection	23.99	10.24	93	45842	26409	29502183
Throat clearing	23.98	10.24	10	45925	213	29528379
Bronchitis	23.90	10.24	117	45818	36751	29491841
Rhinitis	23.67	10.24	33	45902	4745	29523847
Eye infection fungal	23.40	10.24	11	45924	314	29528278
Apoptosis	23.35	10.24	10	45925	228	29528364
Fungal oesophagitis	23.31	10.24	11	45924	317	29528275
Botulism	23.03	10.24	9	45926	161	29528431
Fall	22.95	10.24	171	45764	177007	29351585
Nasopharyngitis	22.92	10.24	165	45770	59500	29469092
Periumbilical abscess	22.77	10.24	7	45928	58	29528534
Hypotension	22.67	10.24	193	45742	194161	29334431
Malignant neoplasm progression	22.42	10.24	51	45884	73808	29454784
Gastrointestinal anastomotic leak	22.30	10.24	11	45924	350	29528242
Granuloma	22.08	10.24	23	45912	2441	29526151
Platelet count decreased	21.88	10.24	86	45849	104586	29424006
Lactic acidosis	21.52	10.24	10	45925	30237	29498355
Eosinophil count increased	21.51	10.24	40	45895	7329	29521263
Intestinal stenosis	21.33	10.24	20	45915	1868	29526724
Gastrooesophageal reflux disease	21.17	10.24	101	45834	31395	29497197
Dyspnoea exertional	21.00	10.24	112	45823	36378	29492214
Tracheitis	20.99	10.24	13	45922	650	29527942
Respiratory distress	20.89	10.24	102	45833	32004	29496588
Hypothalamic pituitary adrenal axis suppression	20.84	10.24	8	45927	136	29528456
Blood pressure increased	20.70	10.24	190	45745	73613	29454979
Inappropriate schedule of product administration	20.69	10.24	129	45806	44343	29484249
Product use in unapproved indication	20.63	10.24	216	45719	86659	29441933
Activated partial thromboplastin time shortened	20.46	10.24	11	45924	420	29528172
White blood cell count decreased	20.43	10.24	64	45871	83298	29445294
Oxygen saturation decreased	20.07	10.24	129	45806	44808	29483784
Retinal ischaemia	20.05	10.24	10	45925	326	29528266
Respiratory disorder	20.02	10.24	65	45870	16918	29511674
Graft versus host disease in gastrointestinal tract	20.00	10.24	25	45910	3233	29525359
Gastrointestinal inflammation	19.95	10.24	24	45911	2984	29525608
Relapsing fever	19.93	10.24	8	45927	154	29528438
Neutrophil count decreased	19.87	10.24	23	45912	43544	29485048
Anaemia	19.82	10.24	208	45727	200743	29327849
Skin striae	19.81	10.24	11	45924	448	29528144
Rotavirus infection	19.59	10.24	10	45925	343	29528249
Penile erythema	19.46	10.24	8	45927	164	29528428
Emphysema	19.25	10.24	42	45893	8629	29519963
Cerebral microangiopathy	19.24	10.24	8	45927	169	29528423
Drug ineffective	19.09	10.24	716	45219	362454	29166138
Blood pressure fluctuation	18.99	10.24	71	45864	19823	29508769
Rash erythematous	18.98	10.24	75	45860	21487	29507105
Ear infection	18.86	10.24	40	45895	8060	29520532
Rhinovirus infection	18.67	10.24	24	45911	3192	29525400
Blood pressure systolic increased	18.54	10.24	63	45872	16782	29511810
Gastrointestinal wall thickening	18.50	10.24	15	45920	1153	29527439
Crohn's disease	18.33	10.24	23	45912	2986	29525606
Osteoporosis	18.30	10.24	47	45888	10722	29517870
Oedema mouth	18.14	10.24	15	45920	1186	29527406
CADASIL	17.93	10.24	6	45929	67	29528525
Rhonchi	17.84	10.24	17	45918	1621	29526971
Carotid arteriosclerosis	17.74	10.24	16	45919	1422	29527170
Intestinal obstruction	17.74	10.24	68	45867	19209	29509383
Electrocardiogram QT prolonged	17.67	10.24	18	45917	36119	29492473
Magnetic resonance imaging spinal abnormal	17.61	10.24	6	45929	71	29528521
Tracheal haemorrhage	17.54	10.24	10	45925	429	29528163
Drug level below therapeutic	17.54	10.24	27	45908	4244	29524348
Nephrectomy	17.48	10.24	12	45923	716	29527876
Varicella zoster virus infection	17.46	10.24	16	45919	1452	29527140
Visual evoked potentials abnormal	17.24	10.24	6	45929	76	29528516
Nasal turbinate hypertrophy	17.10	10.24	6	45929	78	29528514
Blood creatinine increased	17.10	10.24	71	45864	85031	29443561
Adrenocortical insufficiency acute	16.90	10.24	15	45920	1305	29527287
Pouchitis	16.87	10.24	11	45924	602	29527990
Anosmia	16.80	10.24	18	45917	1973	29526619
Cataract	16.69	10.24	74	45861	22304	29506288
Suicide attempt	16.67	10.24	17	45918	34093	29494499
Pulmonary function test decreased	16.65	10.24	26	45909	4137	29524455
Increased upper airway secretion	16.57	10.24	16	45919	1550	29527042
Reversible airways obstruction	16.56	10.24	8	45927	243	29528349
Nausea	16.39	10.24	334	45601	288921	29239671
Adrenal cortex necrosis	16.35	10.24	4	45931	12	29528580
Mucosal inflammation	16.31	10.24	15	45920	31580	29497012
Pharyngitis streptococcal	16.27	10.24	18	45917	2046	29526546
Product quality issue	16.24	10.24	58	45877	15837	29512755
Anaphylactic reaction	16.11	10.24	85	45850	27488	29501104
Hypercapnic coma	16.09	10.24	7	45928	166	29528426
Bronchopulmonary aspergillosis allergic	16.01	10.24	10	45925	508	29528084
Growth retardation	15.98	10.24	16	45919	1620	29526972
Cardiogenic shock	15.89	10.24	5	45930	19185	29509407
Dysbiosis	15.72	10.24	9	45926	389	29528203
Delirium	15.70	10.24	23	45912	39374	29489218
Central nervous system inflammation	15.69	10.24	6	45929	101	29528491
Psychotic disorder	15.65	10.24	6	45929	20348	29508244
Factor V Leiden mutation	15.62	10.24	5	45930	48	29528544
Respiration abnormal	15.56	10.24	20	45915	2660	29525932
Full blood count decreased	15.50	10.24	3	45932	15989	29512603
Stomatitis	15.45	10.24	21	45914	37092	29491500
Status asthmaticus	15.42	10.24	8	45927	284	29528308
Leukopenia	15.27	10.24	40	45895	55163	29473429
Haematochezia	15.20	10.24	104	45831	36879	29491713
Sepsis	15.17	10.24	145	45790	142537	29386055
Defaecation urgency	15.09	10.24	16	45919	1733	29526859
Intentional product use issue	14.88	10.24	115	45820	42383	29486209
Respiratory syncytial virus infection	14.84	10.24	23	45912	3636	29524956
Drug reaction with eosinophilia and systemic symptoms	14.79	10.24	13	45922	27979	29500613
Product substitution error	14.74	10.24	4	45931	20	29528572
Peak expiratory flow rate decreased	14.73	10.24	6	45929	120	29528472
Hypoventilation	14.64	10.24	20	45915	2821	29525771
Necrotising retinitis	14.63	10.24	11	45924	757	29527835
Hypercapnia	14.53	10.24	23	45912	3703	29524889
Eosinophilic oesophagitis	14.51	10.24	7	45928	212	29528380
Short-bowel syndrome	14.45	10.24	7	45928	214	29528378
Dysarthria	14.44	10.24	16	45919	30895	29497697
Rubber sensitivity	14.42	10.24	6	45929	127	29528465
Laryngeal cryptococcosis	14.33	10.24	3	45932	3	29528589
Precursor B-lymphoblastic lymphoma	14.33	10.24	3	45932	3	29528589
Bronchial obstruction	14.32	10.24	14	45921	1377	29527215
Saccadic eye movement	14.29	10.24	6	45929	130	29528462
Gastroenteritis clostridial	14.24	10.24	7	45928	221	29528371
Urinary tract infection	14.14	10.24	61	45874	72293	29456299
Abdominal abscess	14.08	10.24	23	45912	3801	29524791
Rhabdomyolysis	13.98	10.24	48	45887	60760	29467832
Therapeutic response shortened	13.97	10.24	26	45909	4765	29523827
Somnolence	13.97	10.24	87	45848	93868	29434724
Nocardiosis	13.94	10.24	21	45914	3239	29525353
Influenza	13.93	10.24	112	45823	41769	29486823
Necrotising ulcerative gingivostomatitis	13.91	10.24	5	45930	70	29528522
Cerebral artery embolism	13.87	10.24	11	45924	819	29527773
Cortisol decreased	13.86	10.24	11	45924	820	29527772
Aspergillus infection	13.85	10.24	42	45893	10539	29518053
Nasal disorder	13.84	10.24	14	45921	1435	29527157
Dermatitis contact	13.84	10.24	20	45915	2972	29525620
Obstruction	13.82	10.24	16	45919	1910	29526682
Abdominal adhesions	13.74	10.24	13	45922	1228	29527364
Cardio-respiratory arrest	13.74	10.24	37	45898	50564	29478028
Serotonin syndrome	13.74	10.24	5	45930	17507	29511085
Drug level above therapeutic	13.70	10.24	21	45914	3289	29525303
Cytomegalovirus colitis	13.67	10.24	18	45917	2451	29526141
Body temperature decreased	13.65	10.24	42	45893	10622	29517970
Oropharyngeal pain	13.65	10.24	85	45850	29200	29499392
Bacterial toxaemia	13.61	10.24	6	45929	147	29528445
Confusional state	13.57	10.24	130	45805	127747	29400845
Throat irritation	13.56	10.24	37	45898	8748	29519844
Plasma cell myeloma	13.53	10.24	23	45912	37092	29491500
Cystic fibrosis	13.50	10.24	14	45921	1478	29527114
Respiratory tract congestion	13.49	10.24	27	45908	5222	29523370
Foreign body aspiration	13.32	10.24	6	45929	155	29528437
Pneumonia adenoviral	13.28	10.24	6	45929	156	29528436
Small airways disease	13.25	10.24	4	45931	31	29528561
Gastrointestinal mucosa hyperaemia	13.25	10.24	7	45928	258	29528334
Congenital hydronephrosis	13.24	10.24	10	45925	693	29527899
Acute respiratory failure	13.17	10.24	78	45857	26324	29502268
Oesophageal carcinoma recurrent	13.12	10.24	3	45932	6	29528586
Astrovirus test positive	13.12	10.24	3	45932	6	29528586
Rhinorrhoea	13.03	10.24	67	45868	21452	29507140
Constipation	13.00	10.24	114	45821	114046	29414546
Complicated appendicitis	12.92	10.24	4	45931	34	29528558
Pancreatic cyst	12.81	10.24	10	45925	728	29527864
Sleep disorder	12.79	10.24	73	45862	24313	29504279
Sinus operation	12.77	10.24	9	45926	560	29528032
Product monitoring error	12.70	10.24	18	45917	2627	29525965
Asthmatic crisis	12.69	10.24	8	45927	413	29528179
Product administered to patient of inappropriate age	12.65	10.24	18	45917	2637	29525955
Pulmonary oedema	12.57	10.24	30	45905	42705	29485887
Bronchial disorder	12.55	10.24	12	45923	1149	29527443
Secretion discharge	12.47	10.24	23	45912	4187	29524405
Double stranded DNA antibody positive	12.40	10.24	6	45929	183	29528409
Overdose	12.34	10.24	73	45862	79746	29448846
Proctalgia	12.33	10.24	23	45912	4222	29524370
Liver disorder	12.28	10.24	15	45920	27734	29500858
Stoma site abscess	12.26	10.24	4	45931	41	29528551
Sputum increased	12.17	10.24	15	45920	1912	29526680
Coma	12.16	10.24	27	45908	39423	29489169
Lipid metabolism disorder	12.14	10.24	7	45928	307	29528285
Tachypnoea	12.05	10.24	51	45884	15064	29513528
Neuroleptic malignant syndrome	12.02	10.24	5	45930	16143	29512449
Graft versus host disease in skin	12.01	10.24	20	45915	3359	29525233
Psoriatic arthropathy	11.86	10.24	4	45931	14687	29513905
Cardiac arrest	11.84	10.24	81	45854	85510	29443082
Septic embolus	11.63	10.24	11	45924	1039	29527553
Bacterial diarrhoea	11.62	10.24	4	45931	49	29528543
Plantar erythema	11.54	10.24	4	45931	50	29528542
Cor pulmonale chronic	11.54	10.24	4	45931	50	29528542
Bone marrow oedema	11.48	10.24	8	45927	489	29528103
Cholangitis sclerosing	11.48	10.24	11	45924	1056	29527536
Seminoma	11.41	10.24	6	45929	219	29528373
Renal impairment	11.23	10.24	77	45858	81256	29447336
Lung abscess	11.21	10.24	16	45919	2350	29526242
Increased bronchial secretion	11.12	10.24	13	45922	1568	29527024
Respiratory syncytial virus bronchiolitis	11.07	10.24	7	45928	363	29528229
Cerebrovascular accident	11.03	10.24	72	45863	76839	29451753
White coat hypertension	11.00	10.24	4	45931	58	29528534
Haemoptysis	10.87	10.24	83	45852	30467	29498125
Middle insomnia	10.84	10.24	26	45909	5682	29522910
Upper respiratory fungal infection	10.83	10.24	5	45930	137	29528455
Primary myelofibrosis	10.82	10.24	4	45931	61	29528531
Pharyngeal oedema	10.77	10.24	26	45909	5708	29522884
Kidney infection	10.76	10.24	23	45912	4660	29523932
Gastrointestinal polyp	10.74	10.24	3	45932	17	29528575
Anal stenosis	10.73	10.24	5	45930	140	29528452
Paranasal sinus mucosal hypertrophy	10.64	10.24	4	45931	64	29528528
Catheter site related reaction	10.62	10.24	6	45929	253	29528339
Pseudomonas infection	10.58	10.24	39	45896	10813	29517779
Rectal abscess	10.58	10.24	10	45925	944	29527648
Middle ear effusion	10.56	10.24	8	45927	557	29528035
Abscess intestinal	10.44	10.24	12	45923	1422	29527170
Hepatic function abnormal	10.44	10.24	29	45906	39230	29489362
Device malfunction	10.42	10.24	33	45902	8474	29520118
Diabetic ketoacidosis	10.41	10.24	6	45929	16067	29512525
Chronic kidney disease	10.36	10.24	26	45909	36390	29492202
Respiratory failure	10.36	10.24	210	45725	96921	29431671
Leukoplakia oral	10.31	10.24	4	45931	70	29528522
Wound decomposition	10.31	10.24	4	45931	70	29528522
Palmar-plantar erythrodysaesthesia syndrome	10.31	10.24	5	45930	14754	29513838
Poor venous access	10.30	10.24	18	45917	3143	29525449
Physical examination abnormal	10.28	10.24	6	45929	269	29528323
Coeliac disease	10.28	10.24	8	45927	580	29528012
Gastrooesophageal sphincter insufficiency	10.26	10.24	4	45931	71	29528521

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Asthma	1732.31	9.76	1347	103202	93878	64300305
Wheezing	773.58	9.76	795	103754	79784	64314399
Dyspnoea	601.42	9.76	2524	102025	716150	63678033
Cough	419.44	9.76	1256	103293	300892	64093291
Obstructive airways disorder	411.94	9.76	324	104225	22861	64371322
Chest discomfort	319.10	9.76	629	103920	115477	64278706
Completed suicide	264.50	9.76	28	104521	224386	64169797
Toxicity to various agents	253.36	9.76	137	104412	363376	64030807
Full blood count abnormal	228.14	9.76	261	104288	29496	64364687
Colitis ulcerative	227.55	9.76	231	104318	22797	64371386
Productive cough	218.67	9.76	411	104138	72792	64321391
Sleep disorder due to a general medical condition	200.13	9.76	139	104410	8095	64386088
Chronic obstructive pulmonary disease	184.38	9.76	376	104173	70672	64323511
Nasal polyps	166.90	9.76	92	104457	3537	64390646
Drug abuse	154.66	9.76	17	104532	132357	64261826
Eosinophilic granulomatosis with polyangiitis	140.68	9.76	76	104473	2806	64391377
Frequent bowel movements	129.35	9.76	154	104395	18151	64376032
Acute kidney injury	126.93	9.76	344	104205	448896	63945287
Sputum discoloured	124.16	9.76	149	104400	17707	64376476
Chronic sinusitis	118.39	9.76	91	104458	6201	64387982
Bronchospasm	116.22	9.76	159	104390	21523	64372660
Upper-airway cough syndrome	115.23	9.76	103	104446	8667	64385516
Blood immunoglobulin E increased	112.90	9.76	73	104476	3771	64390412
Pneumonia	111.09	9.76	1389	103160	558187	63835996
Contraindicated product administered	107.30	9.76	22	104527	107807	64286376
Forced expiratory volume decreased	107.18	9.76	89	104460	6778	64387405
Eosinophil count increased	106.83	9.76	123	104426	13989	64380194
Bronchiectasis	106.63	9.76	123	104426	14017	64380166
Respiratory symptom	104.79	9.76	64	104485	2989	64391194
Blood test abnormal	103.39	9.76	116	104433	12827	64381356
Gastrooesophageal reflux disease	102.28	9.76	332	104217	82811	64311372
Febrile neutropenia	101.19	9.76	93	104456	187564	64206619
Neutropenia	94.08	9.76	152	104397	239472	64154711
Loss of personal independence in daily activities	93.37	9.76	294	104255	72160	64322023
Polycystic ovaries	91.93	9.76	52	104497	2103	64392080
Heart rate increased	90.57	9.76	358	104191	98317	64295866
Asthmatic crisis	90.46	9.76	48	104501	1708	64392475
Weight decreased	89.14	9.76	778	103771	284961	64109222
Growth failure	89.00	9.76	27	104522	203	64393980
Middle insomnia	82.32	9.76	103	104446	12774	64381409
Hand deformity	78.81	9.76	6	104543	62765	64331418
Off label use	78.18	9.76	1449	103100	631357	63762826
Death	75.95	9.76	465	104084	482240	63911943
Reversible airways obstruction	75.80	9.76	37	104512	1101	64393082
Synovitis	75.47	9.76	33	104516	99057	64295126
Labile blood pressure	74.99	9.76	45	104504	2035	64392148
Faecal calprotectin increased	73.69	9.76	55	104494	3585	64390598
Systemic lupus erythematosus	72.86	9.76	18	104531	77594	64316589
Dust allergy	72.44	9.76	35	104514	1018	64393165
Dyspnoea exertional	72.14	9.76	273	104276	73457	64320726
Intentional overdose	71.66	9.76	28	104521	89916	64304267
Cushingoid	70.99	9.76	74	104475	7529	64386654
Bronchial secretion retention	69.36	9.76	46	104503	2481	64391702
Respiratory tract infection	69.07	9.76	173	104376	37234	64356949
Thrombocytopenia	68.76	9.76	164	104385	223637	64170546
Therapeutic product effect incomplete	68.10	9.76	340	104209	103142	64291041
Breath sounds abnormal	67.77	9.76	89	104460	11580	64382603
Nasal congestion	66.07	9.76	230	104319	59428	64334755
Sleep apnoea syndrome	65.96	9.76	148	104401	29684	64364499
Upper respiratory fungal infection	65.67	9.76	23	104526	284	64393899
Rhinitis allergic	65.55	9.76	73	104476	8005	64386178
Eosinophilic bronchitis	64.83	9.76	24	104525	351	64393832
White blood cell count decreased	62.97	9.76	99	104450	157738	64236445
Platelet count decreased	62.45	9.76	110	104439	167601	64226582
Sinusitis fungal	61.74	9.76	37	104512	1669	64392514
Alopecia	60.50	9.76	110	104439	165580	64228603
Gastrointestinal wall thickening	59.43	9.76	39	104510	2066	64392117
Adrenal suppression	59.27	9.76	33	104516	1294	64392889
Sensitisation	58.68	9.76	36	104513	1695	64392488
Blood pressure increased	58.59	9.76	479	104070	172073	64222110
Vital capacity decreased	57.20	9.76	30	104519	1042	64393141
Condition aggravated	56.84	9.76	883	103666	371543	64022640
Hyper IgE syndrome	54.99	9.76	23	104526	472	64393711
Fall	54.87	9.76	423	104126	416403	63977780
Cushing's syndrome	54.73	9.76	28	104521	923	64393260
Pericarditis	54.02	9.76	17	104532	62499	64331684
Malignant neoplasm progression	53.94	9.76	62	104487	112809	64281374
Arthropathy	52.02	9.76	72	104477	120895	64273288
Hepatic enzyme increased	50.41	9.76	83	104466	129860	64264323
Anaphylactic reaction	49.78	9.76	232	104317	68432	64325751
Peak expiratory flow rate decreased	49.73	9.76	23	104526	605	64393578
Infective pulmonary exacerbation of cystic fibrosis	49.40	9.76	77	104472	11719	64382464
Anosmia	48.61	9.76	47	104502	4370	64389813
Spirometry abnormal	48.45	9.76	22	104527	554	64393629
Rheumatoid arthritis	48.40	9.76	123	104426	164171	64230012
Stomatitis	48.38	9.76	64	104485	109541	64284642
Sputum increased	48.37	9.76	43	104506	3592	64390591
Salpingo-oophorectomy unilateral	48.32	9.76	21	104528	475	64393708
Graft versus host disease	48.16	9.76	83	104466	13730	64380453
Joint swelling	48.05	9.76	183	104366	215199	64178984
Mucosal inflammation	47.40	9.76	21	104528	62563	64331620
Pancytopenia	47.26	9.76	101	104448	143208	64250975
Emphysema	47.05	9.76	83	104466	13986	64380197
Intestinal stenosis	46.75	9.76	40	104509	3174	64391009
Impaired quality of life	46.63	9.76	55	104494	6416	64387767
Butterfly rash	46.35	9.76	27	104522	1155	64393028
Lung diffusion test abnormal	46.03	9.76	15	104534	146	64394037
Hypotension	45.82	9.76	396	104153	380578	64013605
Ileal stenosis	45.51	9.76	33	104516	2057	64392126
Aspergillus infection	45.23	9.76	89	104460	16290	64377893
Mycotic allergy	45.07	9.76	25	104524	973	64393210
Cystic fibrosis	44.46	9.76	40	104509	3394	64390789
Graft versus host disease in gastrointestinal tract	44.31	9.76	50	104499	5562	64388621
Treatment failure	44.04	9.76	76	104473	116740	64277443
Overdose	43.57	9.76	124	104425	159442	64234741
Neutrophil count decreased	43.09	9.76	37	104512	77159	64317024
Female genital tract fistula	42.63	9.76	35	104514	2623	64391560
Systemic mycosis	42.40	9.76	33	104516	2290	64391893
Dysphonia	42.30	9.76	168	104381	46214	64347969
Coma	41.99	9.76	48	104501	87567	64306616
Ejection fraction	41.70	9.76	26	104523	1260	64392923
Duodenal ulcer perforation	41.57	9.76	4	104545	34621	64359562
Ventricular failure	41.28	9.76	19	104530	494	64393689
Glossodynia	41.26	9.76	27	104522	64669	64329514
Multiple allergies	41.21	9.76	49	104500	5765	64388418
Respiration abnormal	41.14	9.76	51	104498	6264	64387919
Dyspnoea at rest	41.05	9.76	51	104498	6278	64387905
Therapeutic reaction time decreased	40.92	9.76	30	104519	1902	64392281
Eosinophilia	40.60	9.76	145	104404	37931	64356252
Rhonchi	40.29	9.76	38	104511	3425	64390758
Mucous stools	40.17	9.76	37	104512	3236	64390947
Helicobacter infection	39.91	9.76	7	104542	38355	64355828
Sinusitis	39.68	9.76	386	104163	145542	64248641
Asphyxia	39.44	9.76	62	104487	9504	64384679
Confusional state	39.20	9.76	255	104294	260889	64133294
Intestinal obstruction	38.54	9.76	138	104411	36148	64358035
Bronchopulmonary aspergillosis allergic	38.52	9.76	27	104522	1595	64392588
Cyanosis	38.34	9.76	100	104449	22055	64372128
Pain	38.32	9.76	649	103900	552862	63841321
Disease progression	38.02	9.76	111	104438	141569	64252614
Swelling	37.78	9.76	133	104416	160085	64234098
Intestinal fistula	37.73	9.76	24	104525	1205	64392978
Impaired healing	37.54	9.76	26	104523	60447	64333736
Lung disorder	36.83	9.76	195	104354	60505	64333678
Respiratory distress	36.60	9.76	175	104374	52156	64342027
Hepatic ischaemia	36.56	9.76	22	104527	1000	64393183
Adrenal insufficiency	36.39	9.76	99	104450	22388	64371795
Somnolence	36.36	9.76	188	104361	203457	64190726
Cardio-respiratory arrest	36.19	9.76	65	104484	98328	64295855
Embolism venous	36.14	9.76	36	104513	3471	64390712
Colitis	35.94	9.76	189	104360	58485	64335698
Drug intolerance	35.60	9.76	170	104379	187822	64206361
Anaemia	35.02	9.76	419	104130	378261	64015922
Bronchomalacia	33.99	9.76	13	104536	209	64393974
Eosinophilic oesophagitis	33.67	9.76	16	104533	448	64393735
Oropharyngeal pain	33.61	9.76	253	104296	88614	64305569
Drug level below therapeutic	33.46	9.76	50	104499	7334	64386849
Rhinorrhoea	33.25	9.76	188	104361	59781	64334402
Intentional self-injury	33.23	9.76	4	104545	29040	64365143
Muscle relaxant therapy	33.16	9.76	12	104537	164	64394019
Rheumatoid factor positive	32.99	9.76	8	104541	34930	64359253
Sinus operation	32.95	9.76	25	104524	1670	64392513
Polyp	32.87	9.76	47	104502	6626	64387557
Bronchitis	32.74	9.76	294	104255	108449	64285734
Throat irritation	32.71	9.76	122	104427	32589	64361594
Mite allergy	32.34	9.76	18	104531	705	64393478
Herpes simplex oesophagitis	31.90	9.76	13	104536	249	64393934
Suicide attempt	31.80	9.76	41	104508	70966	64323217
Sopor	31.77	9.76	5	104544	29656	64364527
Nausea	31.66	9.76	1002	103547	784798	63609385
Eczema	31.53	9.76	113	104436	29607	64364576
Upper respiratory tract infection	31.45	9.76	214	104335	72571	64321612
Conjunctivitis allergic	31.33	9.76	20	104529	1010	64393173
Pulmonary function test decreased	31.08	9.76	45	104504	6416	64387767
Obstruction	31.02	9.76	32	104517	3216	64390967
Ascites	30.77	9.76	33	104516	61968	64332215
Increased upper airway secretion	30.57	9.76	33	104516	3494	64390689
Total lung capacity decreased	30.43	9.76	24	104525	1698	64392485
Colitis microscopic	30.41	9.76	48	104501	7384	64386799
Drug specific antibody	30.32	9.76	26	104523	2069	64392114
Hypothyroidism	30.28	9.76	138	104411	40319	64353864
Nephrectomy	29.94	9.76	22	104527	1400	64392783
Restrictive pulmonary disease	29.51	9.76	26	104523	2146	64392037
Apoptosis	29.32	9.76	13	104536	309	64393874
Blister	29.32	9.76	54	104495	80913	64313270
Sputum culture positive	29.24	9.76	30	104519	2996	64391187
Sepsis	29.20	9.76	236	104313	230105	64164078
Neoplasm progression	29.10	9.76	15	104534	40949	64353234
Sinus disorder	28.93	9.76	76	104473	16832	64377351
Respiratory tract inflammation	28.24	9.76	17	104532	773	64393410
Bronchiolitis	28	9.76	32	104517	3609	64390574
Abdominal pain	27.90	9.76	683	103866	311692	64082491
Psoriatic arthropathy	27.68	9.76	18	104531	43263	64350920
Respiratory disorder	27.64	9.76	124	104425	35987	64358196
Pouchitis	27.58	9.76	17	104532	807	64393376
Hiatus hernia	27.57	9.76	83	104466	19874	64374309
Status asthmaticus	27.49	9.76	18	104531	950	64393233
Leukopenia	27.39	9.76	79	104470	101163	64293020
Pseudomonas infection	27.22	9.76	77	104472	17806	64376377
Frustration tolerance decreased	27.08	9.76	41	104508	6084	64388099
Renal impairment	26.79	9.76	120	104429	134897	64259286
Circumstance or information capable of leading to medication error	26.78	9.76	30	104519	3310	64390873
Haemoptysis	26.69	9.76	153	104396	48895	64345288
Rales	26.62	9.76	69	104480	15160	64379023
Allergy to animal	26.62	9.76	18	104531	1003	64393180
Throat clearing	26.60	9.76	20	104529	1318	64392865
Hyponatraemia	26.43	9.76	137	104412	148202	64245981
Neurotoxicity	26.42	9.76	6	104543	27398	64366785
Osteoporosis	26.08	9.76	136	104413	41944	64352239
Growth retardation	25.97	9.76	21	104528	1540	64392643
Weight gain poor	25.95	9.76	16	104533	760	64393423
Vocal cord dysfunction	25.88	9.76	13	104536	412	64393771
Inappropriate schedule of product administration	25.51	9.76	245	104304	92041	64302142
Sedation	25.51	9.76	18	104531	41444	64352739
Intentional device misuse	25.43	9.76	15	104534	657	64393526
Laryngeal stenosis	25.37	9.76	16	104533	791	64393392
Pulmonary mass	25.21	9.76	91	104458	23925	64370258
Herpes zoster meningoencephalitis	25.06	9.76	15	104534	675	64393508
Respiratory tract congestion	25.00	9.76	70	104479	16095	64378088
Decreased appetite	24.93	9.76	314	104235	280975	64113208
Night sweats	24.81	9.76	120	104429	35926	64358257
Bacterial disease carrier	24.59	9.76	17	104532	982	64393201
Rhinitis	24.46	9.76	54	104495	10711	64383472
Lower respiratory tract infection	24.12	9.76	247	104302	94367	64299816
Product quality issue	24.08	9.76	104	104445	29695	64364488
Lung diffusion test decreased	24.05	9.76	18	104531	1178	64393005
Oropharyngeal discomfort	24.00	9.76	36	104513	5299	64388884
Palpitations	23.94	9.76	267	104282	104221	64289962
Multiple sclerosis relapse	23.84	9.76	19	104530	41116	64353067
Increased bronchial secretion	23.60	9.76	26	104523	2816	64391367
Delayed puberty	23.52	9.76	9	104540	145	64394038
Wound	23.49	9.76	56	104493	76421	64317762
Abdominal discomfort	23.47	9.76	186	104363	182136	64212047
Encephalopathy	23.34	9.76	37	104512	58782	64335401
Mycobacterium test positive	23.28	9.76	12	104537	402	64393781
Venous pressure jugular increased	23.18	9.76	18	104531	1245	64392938
Proctitis	23.01	9.76	27	104522	3132	64391051
Folliculitis	22.92	9.76	10	104539	30067	64364116
Product use in unapproved indication	22.55	9.76	407	104142	176211	64217972
Graft versus host disease in skin	22.52	9.76	35	104514	5312	64388871
Tachypnoea	22.45	9.76	94	104455	26477	64367706
Electrocardiogram QT prolonged	22.22	9.76	61	104488	79387	64314796
Eye swelling	22.19	9.76	83	104466	22198	64371985
Periumbilical abscess	22.17	9.76	7	104542	61	64394122
Nasal obstruction	22.02	9.76	18	104531	1341	64392842
Intestinal resection	21.98	9.76	26	104523	3042	64391141
Procedural pneumothorax	21.87	9.76	7	104542	64	64394119
Botulism	21.86	9.76	11	104538	350	64393833
Haematochezia	21.82	9.76	183	104366	66190	64327993
Secretion discharge	21.73	9.76	55	104494	11909	64382274
Sensitivity to weather change	21.67	9.76	39	104510	6675	64387508
Body temperature decreased	21.34	9.76	91	104458	25837	64368346
Lactic acidosis	21.32	9.76	42	104507	61368	64332815
Plasma cell myeloma	21.26	9.76	26	104523	46049	64348134
Throat tightness	21.20	9.76	84	104465	23076	64371107
Blood creatinine increased	21.16	9.76	131	104418	135651	64258532
Bradycardia	21.16	9.76	109	104440	118110	64276073
Defaecation urgency	20.99	9.76	29	104520	3960	64390223
Therapeutic response shortened	20.87	9.76	49	104500	10121	64384062
Hypoventilation	20.82	9.76	36	104513	5970	64388213
Endometriosis	20.57	9.76	24	104525	2768	64391415
Drug hypersensitivity	20.50	9.76	267	104282	237548	64156635
Rhabdomyolysis	20.39	9.76	78	104471	91648	64302535
Pulmonary artery stenosis congenital	20.23	9.76	5	104544	15	64394168
Product use issue	20.21	9.76	352	104197	151363	64242820
Delirium	20.21	9.76	52	104497	69142	64325041
Bronchial obstruction	20.21	9.76	22	104527	2352	64391831
Sinus congestion	20.20	9.76	63	104486	15376	64378807
Infusion related reaction	20.15	9.76	170	104379	164297	64229886
Aspirin-exacerbated respiratory disease	20.14	9.76	16	104533	1144	64393039
Laryngeal oedema	20.06	9.76	39	104510	7074	64387109
Cytomegalovirus colitis	19.84	9.76	28	104521	3900	64390283
Viral infection	19.83	9.76	113	104436	36027	64358156
Infective exacerbation of chronic obstructive airways disease	19.72	9.76	22	104527	2416	64391767
Eye infection fungal	19.55	9.76	11	104538	440	64393743
Nasopharyngitis	19.41	9.76	435	104114	195638	64198545
Tumour lysis syndrome	19.26	9.76	4	104545	19436	64374747
Cytokine release syndrome	19.22	9.76	5	104544	20824	64373359
Musculoskeletal stiffness	19.13	9.76	119	104430	123087	64271096
Pharyngeal oedema	19.06	9.76	62	104487	15469	64378714
Vomiting	19.05	9.76	716	103833	550401	63843782
Periorbital oedema	18.93	9.76	39	104510	7375	64386808
Respiratory rate increased	18.85	9.76	69	104480	18262	64375921
Poisoning	18.81	9.76	6	104543	21873	64372310
Metabolic acidosis	18.73	9.76	56	104493	70902	64323281
Haemoglobin decreased	18.70	9.76	214	104335	194849	64199334
Peripheral swelling	18.70	9.76	233	104316	208920	64185263
Smoke sensitivity	18.69	9.76	11	104538	480	64393703
Abscess intestinal	18.59	9.76	21	104528	2339	64391844
Otorrhoea	18.52	9.76	17	104532	1480	64392703
Activated partial thromboplastin time shortened	18.49	9.76	13	104536	772	64393411
Drug level above therapeutic	18.45	9.76	37	104512	6864	64387319
Kyphosis	18.35	9.76	21	104528	2372	64391811
Rectal prolapse	18.31	9.76	18	104531	1708	64392475
Osteomyelitis	18.30	9.76	11	104538	27576	64366607
Myelodysplastic syndrome	18.29	9.76	11	104538	27568	64366615
Hepatic function abnormal	18.27	9.76	49	104500	64264	64329919
Hip arthroplasty	18.10	9.76	6	104543	21345	64372838
Nasal discharge discolouration	18.06	9.76	18	104531	1736	64392447
Atypical mycobacterium test positive	18.05	9.76	4	104545	6	64394177
Drug specific antibody present	18.00	9.76	31	104518	5123	64389060
Hypothalamic pituitary adrenal axis suppression	17.92	9.76	9	104540	285	64393898
Hepatorenal syndrome	17.89	9.76	26	104523	3720	64390463
Ligament pain	17.86	9.76	8	104541	195	64393988
Swollen tongue	17.70	9.76	107	104442	34847	64359336
Cardiac arrest	17.66	9.76	162	104387	153902	64240281
Accidental overdose	17.63	9.76	17	104532	33540	64360643
Steroid dependence	17.57	9.76	10	104539	409	64393774
Catarrh	17.53	9.76	11	104538	539	64393644
Infusion site extravasation	17.50	9.76	36	104513	6801	64387382
Tracheostomy infection	17.29	9.76	6	104543	72	64394111
Abdominal abscess	17.10	9.76	34	104515	6270	64387913
Dysarthria	17.07	9.76	45	104504	59361	64334822
Dermatitis contact	17.00	9.76	42	104507	8958	64385225
Drug level decreased	16.99	9.76	49	104500	11454	64382729
Cortisol decreased	16.88	9.76	17	104532	1660	64392523
Bronchitis bacterial	16.88	9.76	15	104534	1252	64392931
Oedema mouth	16.82	9.76	22	104527	2851	64391332
Penile erythema	16.81	9.76	7	104542	142	64394041
Sleep disorder due to general medical condition, insomnia type	16.70	9.76	11	104538	26259	64367924
Tracheitis	16.65	9.76	15	104534	1275	64392908
Cerebrovascular accident	16.50	9.76	143	104406	137440	64256743
Bone marrow failure	16.47	9.76	33	104516	47919	64346264
Candida infection	16.44	9.76	97	104452	31322	64362861
Large intestinal stenosis	16.39	9.76	20	104529	2417	64391766
White coat hypertension	16.26	9.76	10	104539	473	64393710
Bacterial toxaemia	16.20	9.76	7	104542	156	64394027
Device expulsion	16.15	9.76	7	104542	21129	64373054
Malaise	16.13	9.76	791	103758	395456	63998727
Fungal oesophagitis	16.01	9.76	12	104537	787	64393396
Blood pressure fluctuation	15.99	9.76	141	104408	51730	64342453
Mitochondrial neurogastrointestinal encephalopathy	15.94	9.76	4	104545	13	64394170
Swelling face	15.82	9.76	156	104393	59010	64335173
Aphonia	15.82	9.76	40	104509	8657	64385526
Varicella zoster virus infection	15.75	9.76	25	104524	3863	64390320
Hysterectomy	15.73	9.76	29	104520	5056	64389127
Perfume sensitivity	15.72	9.76	11	104538	648	64393535
Obstructive pancreatitis	15.66	9.76	11	104538	652	64393531
Nasal oedema	15.60	9.76	13	104536	995	64393188
Adrenocortical insufficiency acute	15.57	9.76	20	104529	2545	64391638
Neuropathy peripheral	15.53	9.76	119	104430	117406	64276777
Adrenal cortex necrosis	15.50	9.76	4	104545	15	64394168
Aphthous ulcer	15.37	9.76	51	104498	12855	64381328
Stridor	15.33	9.76	28	104521	4846	64389337
Sputum purulent	15.32	9.76	14	104535	1212	64392971
Cardiogenic shock	15.28	9.76	18	104531	32409	64361774
Type 2 diabetes mellitus	15.28	9.76	101	104448	33919	64360264
Sleep disorder	15.27	9.76	156	104393	59553	64334630
Nasal disorder	15.23	9.76	21	104528	2863	64391320
Rash	14.89	9.76	600	103949	457949	63936234
Liver disorder	14.89	9.76	41	104508	53310	64340873
Mobility decreased	14.88	9.76	80	104469	85760	64308423
Retinal ischaemia	14.85	9.76	11	104538	709	64393474
Pharyngeal hypoaesthesia	14.77	9.76	8	104541	297	64393886
Hyperplastic cholecystopathy	14.63	9.76	6	104543	117	64394066
Respiratory arrest	14.58	9.76	41	104508	52944	64341239
Feeling jittery	14.47	9.76	44	104505	10591	64383592
Bowel movement irregularity	14.40	9.76	27	104522	4766	64389417
Superinfection	14.40	9.76	24	104525	3862	64390321
Gastroenteritis norovirus	14.34	9.76	20	104529	2755	64391428
Myocardial infarction	14.34	9.76	186	104363	165635	64228548
Lip infection	14.26	9.76	6	104543	125	64394058
Incorrect dose administered	14.25	9.76	156	104393	60609	64333574
Laryngeal cryptococcosis	14.21	9.76	3	104546	3	64394180
Inflammatory bowel disease	14.19	9.76	26	104523	4512	64389671
Oligoarthritis	14.13	9.76	8	104541	324	64393859
Extrapyramidal disorder	14.12	9.76	7	104542	19545	64374638
Rotavirus infection	14.08	9.76	10	104539	603	64393580
Blood bilirubin increased	14.08	9.76	47	104502	57506	64336677
Depressed level of consciousness	14.06	9.76	76	104473	81360	64312823
Tooth discolouration	14.02	9.76	12	104537	953	64393230
Proctalgia	13.99	9.76	35	104514	7524	64386659
Type IV hypersensitivity reaction	13.86	9.76	22	104527	3400	64390783
Abscess	13.82	9.76	65	104484	19239	64374944
Norovirus infection	13.73	9.76	7	104542	229	64393954
Aspartate aminotransferase increased	13.70	9.76	126	104423	119662	64274521
Cryptosporidiosis infection	13.60	9.76	10	104539	637	64393546
Mental status changes	13.60	9.76	52	104497	61110	64333073
Blood cholesterol increased	13.58	9.76	39	104510	50027	64344156
Bulimia nervosa	13.56	9.76	7	104542	235	64393948
Influenza	13.41	9.76	245	104304	106286	64287897
Bronchial wall thickening	13.40	9.76	16	104533	1891	64392292
Hypersensitivity pneumonitis	13.40	9.76	21	104528	3211	64390972
Oxygen saturation decreased	13.32	9.76	246	104303	106930	64287253
Small intestinal stenosis	13.27	9.76	10	104539	661	64393522
Tremor	13.17	9.76	324	104225	147906	64246277
Red blood cell sedimentation rate abnormal	13.11	9.76	5	104544	16301	64377882
Rhinovirus infection	13.00	9.76	30	104519	6126	64388057
Astrovirus test positive	12.99	9.76	3	104546	6	64394177
Atopy	12.99	9.76	7	104542	257	64393926
Orthostatic hypotension	12.98	9.76	36	104513	46702	64347481
Sneezing	12.92	9.76	54	104495	15197	64378986
Hypercapnic coma	12.90	9.76	8	104541	384	64393799
Infrapatellar fat pad inflammation	12.86	9.76	6	104543	161	64394022
Posterior reversible encephalopathy syndrome	12.80	9.76	11	104538	22935	64371248
Drug reaction with eosinophilia and systemic symptoms	12.77	9.76	45	104504	54172	64340011
Pneumonia pseudomonal	12.77	9.76	26	104523	4877	64389306
Oesophageal candidiasis	12.68	9.76	35	104514	7982	64386201
Cardiac failure congestive	12.61	9.76	143	104406	130437	64263746
Miosis	12.60	9.76	3	104546	13263	64380920
Psychotic disorder	12.57	9.76	23	104526	34555	64359628
Blood pressure systolic increased	12.55	9.76	129	104420	49324	64344859
Gastrointestinal anastomotic leak	12.53	9.76	8	104541	404	64393779
Rectal abscess	12.51	9.76	14	104535	1543	64392640
Hepatotoxicity	12.48	9.76	29	104520	39933	64354250
Bronchopulmonary dysplasia	12.47	9.76	6	104543	173	64394010
Asthma-chronic obstructive pulmonary disease overlap syndrome	12.43	9.76	12	104537	1113	64393070
Nocturnal dyspnoea	12.42	9.76	13	104536	1329	64392854
Vocal cord disorder	12.41	9.76	13	104536	1330	64392853
Acquired diaphragmatic eventration	12.37	9.76	9	104540	564	64393619
Hypoglycaemia	12.36	9.76	90	104459	89802	64304381
Aural polyp	12.21	9.76	5	104544	97	64394086
Injury	12.19	9.76	48	104501	55944	64338239
Lung opacity	12.18	9.76	20	104529	3179	64391004
Alternaria infection	12.16	9.76	9	104540	579	64393604
Poor venous access	12.15	9.76	46	104503	12371	64381812
Acute myeloid leukaemia	12.15	9.76	16	104533	27447	64366736
Congenital hydronephrosis	12.14	9.76	3	104546	9	64394174
Ear infection	12.08	9.76	72	104477	23332	64370851
Acute myocardial infarction	12.07	9.76	65	104484	69653	64324530
Post viral fatigue syndrome	12.07	9.76	7	104542	297	64393886
Terminal insomnia	12.03	9.76	11	104538	953	64393230
Gastrointestinal polyp	12.00	9.76	4	104545	42	64394141
Product substitution error	12.00	9.76	4	104545	42	64394141
Seminoma	11.98	9.76	6	104543	189	64393994
Weight fluctuation	11.97	9.76	35	104514	8247	64385936
Infusion site swelling	11.95	9.76	27	104522	5438	64388745
Seasonal allergy	11.94	9.76	44	104505	11682	64382501
Urinary tract infection	11.92	9.76	285	104264	231311	64162872
Exposure to allergen	11.92	9.76	6	104543	191	64393992
Tracheal haemorrhage	11.92	9.76	9	104540	597	64393586
Stoma site abscess	11.86	9.76	6	104543	193	64393990
Oropharyngeal swelling	11.86	9.76	12	104537	1179	64393004
Hyperadrenocorticism	11.82	9.76	7	104542	309	64393874
Respiratory syncytial virus infection	11.76	9.76	32	104517	7236	64386947
Skin striae	11.73	9.76	13	104536	1417	64392766
Urticaria	11.63	9.76	317	104232	147000	64247183
Metastases to liver	11.59	9.76	13	104536	23928	64370255
Septic shock	11.59	9.76	112	104437	105325	64288858
Respiratory syncytial virus bronchiolitis	11.59	9.76	8	104541	461	64393722
Complex regional pain syndrome	11.54	9.76	14	104535	1682	64392501
Skin dystrophy	11.52	9.76	4	104545	48	64394135
Cognitive disorder	11.51	9.76	48	104501	55039	64339144
Distal intestinal obstruction syndrome	11.51	9.76	9	104540	629	64393554
Pertussis	11.50	9.76	10	104539	811	64393372
Complicated appendicitis	11.45	9.76	4	104545	49	64394134
Cross sensitivity reaction	11.43	9.76	20	104529	3347	64390836
Sprue-like enteropathy	11.42	9.76	11	104538	1018	64393165
Collateral circulation	11.38	9.76	4	104545	50	64394133
Axillary pain	11.30	9.76	14	104535	1718	64392465
Pleural effusion	11.30	9.76	141	104408	126418	64267765
Hyperkalaemia	11.30	9.76	107	104442	101022	64293161
Legionella test positive	11.28	9.76	3	104546	13	64394170
Alanine aminotransferase increased	11.28	9.76	158	104391	138873	64255310
Drug withdrawal syndrome	11.21	9.76	21	104528	31270	64362913
Oropharyngeal candidiasis	11.12	9.76	13	104536	1502	64392681
Necrotising retinitis	11.12	9.76	11	104538	1052	64393131
Tongue blistering	11.04	9.76	12	104537	1281	64392902
Coprolalia	11.03	9.76	4	104545	55	64394128
Pulmonary function test abnormal	11.01	9.76	19	104530	3145	64391038
Illness	11.01	9.76	67	104482	21871	64372312
Use of accessory respiratory muscles	10.98	9.76	7	104542	353	64393830
Relapsing fever	10.98	9.76	7	104542	353	64393830
Irritable bowel syndrome	10.97	9.76	28	104521	37341	64356842
Pneumonia aspiration	10.97	9.76	54	104495	59217	64334966
Device ineffective	10.90	9.76	5	104544	129	64394054
Neutropenic sepsis	10.88	9.76	13	104536	23259	64370924
Allergic respiratory disease	10.84	9.76	4	104545	58	64394125
Osteonecrosis of jaw	10.82	9.76	31	104518	39794	64354389
Toxic epidermal necrolysis	10.80	9.76	28	104521	37138	64357045
Perirectal abscess	10.79	9.76	14	104535	1799	64392384
Carotid arteriosclerosis	10.77	9.76	15	104534	2064	64392119
Gastrointestinal inflammation	10.76	9.76	28	104521	6167	64388016
Muscle spasms	10.72	9.76	302	104247	140721	64253462
Laryngitis fungal	10.69	9.76	5	104544	135	64394048
Campylobacter gastroenteritis	10.67	9.76	11	104538	1105	64393078
Lower respiratory tract congestion	10.59	9.76	18	104531	2943	64391240
Herpes zoster oticus	10.58	9.76	7	104542	376	64393807
Atelectasis	10.51	9.76	78	104471	27188	64366995
Granuloma	10.51	9.76	29	104520	6612	64387571
Cytopenia	10.50	9.76	6	104543	15465	64378718
Hypercalcaemia	10.46	9.76	22	104527	31394	64362789
Abdominal adhesions	10.46	9.76	18	104531	2974	64391209
Renal injury	10.45	9.76	6	104543	15423	64378760
Leukoplakia oral	10.42	9.76	6	104543	251	64393932
Bronchospasm paradoxical	10.39	9.76	5	104544	144	64394039
Sinusitis bacterial	10.39	9.76	11	104538	1139	64393044
Serotonin syndrome	10.37	9.76	31	104518	39251	64354932
Infective exacerbation of bronchiectasis	10.25	9.76	9	104540	739	64393444
Multiple organ dysfunction syndrome	10.21	9.76	110	104439	101303	64292880
Blood calcium decreased	10.21	9.76	16	104533	25538	64368645
Blood pressure systolic	10.20	9.76	4	104545	69	64394114
Akathisia	10.18	9.76	3	104546	11507	64382676
Nasal discomfort	10.16	9.76	22	104527	4306	64389877
Functional residual capacity decreased	10.15	9.76	4	104545	70	64394113
Pulseless electrical activity	10.09	9.76	4	104545	12735	64381448
Nervousness	9.98	9.76	82	104467	29474	64364709
Clostridium difficile infection	9.98	9.76	96	104453	36067	64358116
Tooth disorder	9.96	9.76	13	104536	22389	64371794
Diarrhoea	9.94	9.76	1023	103526	721681	63672502
Gastrointestinal mucosa hyperaemia	9.93	9.76	7	104542	417	64393766
Unevaluable event	9.93	9.76	45	104504	50444	64343739
Diverticulum	9.86	9.76	45	104504	13153	64381030
Adenovirus infection	9.86	9.76	30	104519	7225	64386958
Diabetic ketoacidosis	9.86	9.76	21	104528	29824	64364359
Febrile bone marrow aplasia	9.83	9.76	3	104546	11252	64382931
Nocardiosis	9.82	9.76	23	104526	4744	64389439
Fungal disease carrier	9.81	9.76	6	104543	281	64393902
Hypertension	9.80	9.76	514	104035	258747	64135436
Musculoskeletal chest pain	9.78	9.76	64	104485	21415	64372768

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A07EA06	ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS INTESTINAL ANTIINFLAMMATORY AGENTS Corticosteroids acting locally
ATC	D07AC09	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, potent (group III)
ATC	R01AD05	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
ATC	R03AK07	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AK12	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AL11	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03BA02	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS Glucocorticoids
FDA MoA	N0000175450	Corticosteroid Hormone Receptor Agonists
FDA EPC	N0000175576	Corticosteroid
CHEBI has role	CHEBI:35472	anti-inflammatory drugs
CHEBI has role	CHEBI:35523	bronchodilator
CHEBI has role	CHEBI:88188	allergenic drug
MeSH PA	D018927	Anti-Asthmatic Agents
MeSH PA	D000893	Anti-Inflammatory Agents
MeSH PA	D001993	Bronchodilator Agents
MeSH PA	D005938	Glucocorticoids
MeSH PA	D006728	Hormones
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D019141	Respiratory System Agents

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

Disease	Relation	SNOMED_ID	DOID
Crohn's disease	indication	34000006
Allergic rhinitis	indication	61582004
Asthma	indication	195967001	DOID:2841
Eosinophilic esophagitis	indication	235599003	DOID:13922
Severe chronic obstructive pulmonary disease	indication	313299006
Asthma management	indication	406162001
Crohn's disease in remission	indication	426549001
Chronic Non-Allergic Rhinitis	indication
Allergic Rhinitis Prevention	indication
Infection by Strongyloides	contraindication	1214006	DOID:10955
Mycosis	contraindication	3218000	DOID:1564
Ocular hypertension	contraindication	4210003	DOID:9282
Gastritis	contraindication	4556007	DOID:4029
Inactive tuberculosis	contraindication	11999007
Epistaxis	contraindication	12441001
Peptic ulcer	contraindication	13200003	DOID:750
Hypercholesterolemia	contraindication	13644009
Measles	contraindication	14189004	DOID:8622
Disease caused by parasite	contraindication	17322007
Cirrhosis of liver	contraindication	19943007	DOID:5082
Arginase deficiency	contraindication	23501004	DOID:9278
Glaucoma	contraindication	23986001	DOID:1686
Acute tuberculosis	contraindication	25629007
Viral disease	contraindication	34014006	DOID:934
Immunosuppression	contraindication	38013005
Hypertensive disorder	contraindication	38341003	DOID:10763
Infectious disease	contraindication	40733004
Hypothyroidism	contraindication	40930008	DOID:1459
Hypokalemia	contraindication	43339004
Hypercortisolism	contraindication	47270006
Chronic heart failure	contraindication	48447003
Cerebral malaria	contraindication	53622003	DOID:14069
Tuberculosis	contraindication	56717001
Congenital hyperammonemia, type I	contraindication	62522004
Osteoporosis	contraindication	64859006	DOID:11476
Psychotic disorder	contraindication	69322001
Diabetes mellitus	contraindication	73211009	DOID:9351
Hypopituitarism	contraindication	74728003	DOID:9406
Perforation of nasal septum	contraindication	80142000
Hyperglycemia	contraindication	80394007	DOID:4195
Open-angle glaucoma	contraindication	84494001	DOID:1067
Bacterial infectious disease	contraindication	87628006
Muscle atrophy	contraindication	88092000	DOID:767
Herpes simplex	contraindication	88594005	DOID:8566
Operation on nose	contraindication	88733004
Bilateral cataracts	contraindication	95722004
Seizure disorder	contraindication	128613002
Disorder of muscle	contraindication	129565002	DOID:423
Pulmonary tuberculosis	contraindication	154283005	DOID:2957
Ophthalmic herpes simplex	contraindication	186542001
Anastomosis of intestine	contraindication	235407009
Disease of liver	contraindication	235856003	DOID:409
Edema	contraindication	267038008
Pathological fracture	contraindication	268029009
Diverticulitis of gastrointestinal tract	contraindication	271366000
Cerebral trauma	contraindication	275382005
Varicella-zoster virus infection	contraindication	309465005
Osteopenia	contraindication	312894000
Adrenal cortical hypofunction	contraindication	386584007	DOID:10493
Avascular necrosis of bone	contraindication	397758007	DOID:10159
Citrullinemia	contraindication	398680004	DOID:9273
Traumatic rupture of tendon	contraindication	415749005
Exposure to varicella	contraindication	444453009
Arginosuccinate Lyase Deficiency	contraindication
Uncontrolled Bacterial Infections	contraindication
Nasal Septal Ulcers	contraindication
Nasal Trauma	contraindication
Untreated Fungal Infection	contraindication
Nasal Candidiasis	contraindication
Oropharyngeal Candidiasis	contraindication
Ornithine Carbamyltransferase Deficiency	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.8	acidic
pKa2	12.78	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	10166247	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	10166247	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	10166247	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	7759328	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	7759328	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	7759328	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8143239	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8143239	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8143239	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8575137	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8575137	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8575137	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	10166247	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	10166247	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	10166247	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	7759328	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	7759328	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	7759328	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8143239	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8143239	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8143239	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8575137	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8575137	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.16MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8575137	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
4MG	TARPEYO	CALLIDITAS	N215935	Dec. 15, 2021	RX	CAPSULE, DELAYED RELEASE	ORAL	8491932	May 7, 2029	TREATMENT OF PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) IN ADULTS AT RISK OF RAPID DISEASE PROGRESSION
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	10716753	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	8324266	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	8703806	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	8808713	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	9415009	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	9463161	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	8815258	March 17, 2031	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
9MG	UCERIS	SALIX	N203634	Jan. 14, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	9192581	Sept. 7, 2031	INDUCTION OF REMISSION IN PATIENTS WITH ACTIVE, MILD TO MODERATE ULCERATIVE COLITIS
6MG	ORTIKOS	SUN PHARM INDS INC	N211929	June 13, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10172802	Sept. 9, 2036	TREATMENT OF MILD TO MODERATE ACTIVE CROHNS DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON
6MG	ORTIKOS	SUN PHARM INDS INC	N211929	June 13, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	9707182	Sept. 9, 2036	TREATMENT OF MILD TO MODERATE ACTIVE CROHNS DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON
9MG	ORTIKOS	SUN PHARM INDS INC	N211929	June 13, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10172802	Sept. 9, 2036	TREATMENT OF MILD TO MODERATE ACTIVE CROHNS DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON
9MG	ORTIKOS	SUN PHARM INDS INC	N211929	June 13, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	9707182	Sept. 9, 2036	TREATMENT OF MILD TO MODERATE ACTIVE CROHNS DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	July 23, 2023	NEW COMBINATION
4MG	TARPEYO	CALLIDITAS	N215935	Dec. 15, 2021	RX	CAPSULE, DELAYED RELEASE	ORAL	Dec. 15, 2024	NEW PRODUCT

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST	EC50	10.30	WOMBAT-PK	CHEMBL
Interleukin-5	Cytokine	P05113	IL5_HUMAN		IC50	9.92	WOMBAT-PK
Interferon gamma	Cytokine	P01579	IFNG_HUMAN		IC50	9.50	WOMBAT-PK
Mineralocorticoid receptor	Nuclear hormone receptor	P08235	MCR_HUMAN	AGONIST	EC50	7.85	IUPHAR
Progesterone receptor	Nuclear hormone receptor	P06401	PRGR_HUMAN	AGONIST	EC50	7.55	IUPHAR
Matrix metalloproteinase-9	Enzyme	P14780	MMP9_HUMAN		IC50	5.70	DRUG MATRIX
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN				WOMBAT-PK
Androgen receptor	Transcription factor		ANDR_RAT		Ki	5.96	DRUG MATRIX
Progesterone receptor	Transcription factor		Q690N0_BOVIN		Ki	7.57	DRUG MATRIX
Glucocorticoid receptor	Transcription factor		GCR_RAT		IC50	8.54	CHEMBL
Interleukin-5	Unclassified		IL5_MOUSE		IC50	4.58	CHEMBL
Interleukin-5 receptor subunit alpha	Unclassified		IL5RA_MOUSE		IC50	4.58	CHEMBL

External reference:

ID	Source
4020889	VUID
N0000148384	NUI
D00246	KEGG_DRUG
19831	RXNORM
C0054201	UMLSCUI
CHEBI:3207	CHEBI
CHEMBL1370	ChEMBL_ID
D019819	MESH_DESCRIPTOR_UI
DB01222	DRUGBANK_ID
5281004	PUBCHEM_CID
7434	IUPHAR_LIGAND_ID
4145	INN_ID
Q3OKS62Q6X	UNII
4303	MMSL
44092	MMSL
d04276	MMSL
004214	NDDF
108622005	SNOMEDCT_US
395726003	SNOMEDCT_US
4020889	VANDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0093-6815	SUSPENSION	0.25 mg	RESPIRATORY (INHALATION)	ANDA	26 sections
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0093-6815	SUSPENSION	0.25 mg	RESPIRATORY (INHALATION)	ANDA	26 sections
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0093-6816	SUSPENSION	0.50 mg	RESPIRATORY (INHALATION)	ANDA	26 sections
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0093-6816	SUSPENSION	0.50 mg	RESPIRATORY (INHALATION)	ANDA	26 sections
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0093-6817	SUSPENSION	1 mg	RESPIRATORY (INHALATION)	ANDA	26 sections
Budesonide Inhalation	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1687	SUSPENSION	0.25 mg	RESPIRATORY (INHALATION)	ANDA	25 sections
Budesonide Inhalation	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1689	SUSPENSION	0.50 mg	RESPIRATORY (INHALATION)	ANDA	25 sections
SYMBICORT	HUMAN PRESCRIPTION DRUG LABEL	2	0186-0370	AEROSOL	160 ug	RESPIRATORY (INHALATION)	NDA	28 sections
SYMBICORT	HUMAN PRESCRIPTION DRUG LABEL	2	0186-0372	AEROSOL	80 ug	RESPIRATORY (INHALATION)	NDA	28 sections
PULMICORTFLEXHALER	HUMAN PRESCRIPTION DRUG LABEL	1	0186-0916	AEROSOL, POWDER	180 ug	RESPIRATORY (INHALATION)	NDA	25 sections
PULMICORTFLEXHALER	HUMAN PRESCRIPTION DRUG LABEL	1	0186-0917	AEROSOL, POWDER	90 ug	RESPIRATORY (INHALATION)	NDA	25 sections
PULMICORT RESPULES	HUMAN PRESCRIPTION DRUG LABEL	1	0186-1988	SUSPENSION	0.25 mg	RESPIRATORY (INHALATION)	NDA	25 sections
PULMICORT RESPULES	HUMAN PRESCRIPTION DRUG LABEL	1	0186-1989	SUSPENSION	0.50 mg	RESPIRATORY (INHALATION)	NDA	25 sections
PULMICORT RESPULES	HUMAN PRESCRIPTION DRUG LABEL	1	0186-1990	SUSPENSION	1 mg	RESPIRATORY (INHALATION)	NDA	25 sections
BREZTRI	HUMAN PRESCRIPTION DRUG LABEL	3	0310-4616	AEROSOL, METERED	160 ug	RESPIRATORY (INHALATION)	NDA	28 sections
Budesonide and Formoterol Fumarate Dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0310-7370	AEROSOL	160 ug	RESPIRATORY (INHALATION)	NDA authorized generic	28 sections
Budesonide and Formoterol Fumarate Dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0310-7372	AEROSOL	80 ug	RESPIRATORY (INHALATION)	NDA authorized generic	28 sections
Budesonide	HUMAN OTC DRUG LABEL	1	0363-0048	SPRAY, METERED	32 ug	NASAL	ANDA	15 sections
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4500	TABLET, FILM COATED, EXTENDED RELEASE	9 mg	ORAL	ANDA	28 sections
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0378-7155	CAPSULE, DELAYED RELEASE	3 mg	ORAL	ANDA	29 sections
BREYNA	HUMAN PRESCRIPTION DRUG LABEL	2	0378-7502	AEROSOL, METERED	80 ug	RESPIRATORY (INHALATION)	ANDA	29 sections
BREYNA	HUMAN PRESCRIPTION DRUG LABEL	2	0378-7503	AEROSOL, METERED	160 ug	RESPIRATORY (INHALATION)	ANDA	29 sections
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0487-9601	INHALANT	0.25 mg	RESPIRATORY (INHALATION)	ANDA	27 sections
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0487-9701	INHALANT	0.50 mg	RESPIRATORY (INHALATION)	ANDA	27 sections
Budesonide	HUMAN OTC DRUG LABEL	1	0536-1112	SPRAY, METERED	32 ug	NASAL	ANDA	15 sections
Entocort EC	HUMAN PRESCRIPTION DRUG LABEL	1	0574-9850	CAPSULE	3 mg	ORAL	NDA	28 sections
budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0574-9855	CAPSULE	3 mg	ORAL	NDA	27 sections
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2510	TABLET, FILM COATED, EXTENDED RELEASE	9 mg	ORAL	ANDA	27 sections
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2510	TABLET, FILM COATED, EXTENDED RELEASE	9 mg	ORAL	ANDA	27 sections
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0781-7515	SUSPENSION	0.25 mg	RESPIRATORY (INHALATION)	ANDA	26 sections