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

Stem definition	Drug id	CAS RN
prednisone and prednisolone derivatives	1832	83919-23-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: mometasone furoate hydrate mometasone furoate asmanex ecural elomet nasonex mometasone furoate monohydrate	A pregnadienediol derivative ANTI-ALLERGIC AGENT and ANTI-INFLAMMATORY AGENT that is used in the management of ASTHMA and ALLERGIC RHINITIS. It is also used as a topical treatment for skin disorders. Molecular weight: 521.43 Formula: C27H30Cl2O6 CLOGP: 4.12 LIPINSKI: 1 HAC: 6 HDO: 1 TPSA: 93.81 ALOGS: -4.68 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

mometasone furoate hydrate
mometasone furoate
asmanex
ecural
elomet
nasonex
mometasone furoate monohydrate

A pregnadienediol derivative ANTI-ALLERGIC AGENT and ANTI-INFLAMMATORY AGENT that is used in the management of ASTHMA and ALLERGIC RHINITIS. It is also used as a topical treatment for skin disorders.

Molecular weight: 521.43
Formula: C27H30Cl2O6
CLOGP: 4.12
LIPINSKI: 1
HAC: 6
HDO: 1
TPSA: 93.81
ALOGS: -4.68
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.20	mg	N
0.40	mg	Inhal.powder

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.02 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	2.20 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	12.70 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.01 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	4.40 hours	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	0.00 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K
BA (Bioavailability)	0.01 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

Date	Agency	Company
April 30, 1987	FDA	MERCK SHARP DOHME
June 29, 2020	PMDA	Novartis Pharma K.K.
May 30, 2020	EMA	Novartis Europharm Limited

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 quality issue	4905.95	11.49	1780	74525	34085	63378632
No adverse event	2975.56	11.49	1292	75013	40113	63372604
Poor quality device used	2499.22	11.49	564	75741	1507	63411210
Product dose omission issue	1860.33	11.49	1813	74492	232500	63180217
Asthma	716.31	11.49	823	75482	126738	63285979
Product container issue	623.33	11.49	181	76124	1612	63411105
Gastrooesophageal reflux disease	563.62	11.49	633	75672	95006	63317711
Device malfunction	558.60	11.49	317	75988	17540	63395177
Wheezing	511.52	11.49	602	75703	94993	63317724
Rhinitis allergic	396.15	11.49	219	76086	11508	63401209
Circumstance or information capable of leading to medication error	375.82	11.49	150	76155	3720	63408997
Ejection fraction	326.34	11.49	119	76186	2287	63410430
Sleep disorder due to a general medical condition	324.65	11.49	195	76110	11993	63400724
Sensitisation	310.70	11.49	126	76179	3260	63409457
Sputum discoloured	300.32	11.49	207	76098	16140	63396577
Polycystic ovaries	292.85	11.49	131	76174	4340	63408377
Cough	268.51	11.49	867	75438	291876	63120841
Sleep apnoea syndrome	243.88	11.49	233	76072	28900	63383817
Blood test abnormal	243.49	11.49	179	76126	15450	63397267
Nasal polyps	232.45	11.49	123	76182	5916	63406801
Productive cough	225.23	11.49	326	75979	62882	63349835
Dyspnoea	203.22	11.49	1423	74882	659890	62752827
Synovitis	197.23	11.49	6	76299	186912	63225805
Full blood count abnormal	195.26	11.49	215	76090	31502	63381215
Glossodynia	174.58	11.49	10	76295	178866	63233851
Obstructive airways disorder	174.08	11.49	166	76139	20533	63392184
Contraindicated product administered	173.63	11.49	27	76278	217621	63195096
Toxicity to various agents	165.76	11.49	46	76259	247204	63165513
Hand deformity	165.09	11.49	6	76299	159451	63253266
Systemic lupus erythematosus	164.21	11.49	27	76278	208891	63203826
Pneumonia aspiration	157.72	11.49	201	76104	34339	63378378
Incorrect dose administered	154.98	11.49	267	76038	59701	63353016
Nasal congestion	146.23	11.49	274	76031	65386	63347331
Bronchiectasis	136.77	11.49	130	76175	16012	63396705
Presbyacusis	135.34	11.49	67	76238	2798	63409919
Infective pulmonary exacerbation of cystic fibrosis	135.11	11.49	100	76205	8717	63404000
Death	132.49	11.49	153	76152	374228	63038489
Carpal tunnel syndrome	131.39	11.49	143	76162	20674	63392043
Pericarditis	129.47	11.49	7	76298	131572	63281145
Steroid withdrawal syndrome	129.27	11.49	41	76264	504	63412213
Pleural fibrosis	128.78	11.49	69	76236	3403	63409314
Asthma-chronic obstructive pulmonary disease overlap syndrome	127.39	11.49	58	76247	2003	63410714
Wound	126.28	11.49	22	76283	163241	63249476
Pleural thickening	120.32	11.49	62	76243	2821	63409896
Burning sensation	114.90	11.49	222	76083	54185	63358532
Chest discomfort	113.71	11.49	340	75965	109629	63303088
Deafness neurosensory	112.28	11.49	71	76234	4784	63407933
Total lung capacity increased	112.04	11.49	55	76250	2255	63410462
Blood magnesium increased	111.63	11.49	60	76245	2978	63409739
Bronchopulmonary aspergillosis allergic	110.23	11.49	54	76251	2204	63410513
Maternal exposure during pregnancy	109.94	11.49	64	76241	219998	63192719
Alopecia	107.87	11.49	149	76156	337387	63075330
Abdominal discomfort	104.19	11.49	140	76165	320745	63091972
Ejection fraction abnormal	103.34	11.49	48	76257	1737	63410980
Off label use	101.45	11.49	442	75863	674020	62738697
Acute kidney injury	99.36	11.49	102	76203	263313	63149404
Neutropenia	97.68	11.49	44	76261	174961	63237756
Nephrectomy	94.99	11.49	43	76262	1465	63411252
Sinusitis	94.27	11.49	528	75777	226125	63186592
Joint swelling	93.72	11.49	156	76149	327510	63085207
Underdose	92.52	11.49	138	76167	27318	63385399
Helicobacter infection	91.07	11.49	5	76300	92780	63319937
Rheumatoid factor positive	87.95	11.49	3	76302	84403	63328314
Swelling	87.50	11.49	122	76183	275256	63137461
Arthropathy	87.31	11.49	92	76213	234700	63178017
Therapeutic product effect incomplete	86.45	11.49	338	75967	124718	63287999
Epigastric discomfort	84.45	11.49	68	76237	6712	63406005
Rales	81.48	11.49	88	76217	12609	63400108
Sinus disorder	80.72	11.49	122	76183	24431	63388286
Infusion related reaction	79.77	11.49	107	76198	245414	63167303
Cardiac disorder	77.90	11.49	182	76123	50634	63362083
Cyst	75.60	11.49	89	76216	14010	63398707
Hypothyroidism	74.65	11.49	161	76144	42471	63370246
Thrombocytopenia	73.99	11.49	45	76260	151112	63261605
General physical health deterioration	72.56	11.49	81	76224	201321	63211396
Asthma exercise induced	71.62	11.49	23	76282	295	63412422
Sarcoidosis	71.33	11.49	63	76242	7059	63405658
Drug abuse	70.88	11.49	4	76301	72514	63340203
Lung opacity	69.96	11.49	45	76260	3123	63409594
Intentional overdose	69.76	11.49	5	76300	74147	63338570
Product taste abnormal	68.14	11.49	38	76267	2029	63410688
Coma	67.43	11.49	200	76105	64164	63348553
Rhinitis	66.41	11.49	75	76230	11291	63401426
Factor V Leiden mutation	65.82	11.49	20	76285	211	63412506
Bone cyst	65.08	11.49	38	76267	2216	63410501
Renal disorder	64.12	11.49	130	76175	32844	63379873
Osteopenia	61.79	11.49	96	76209	19689	63393028
Discomfort	60.62	11.49	67	76238	167307	63245410
Vomiting	60.60	11.49	409	75896	559208	62853509
Confusional state	60.00	11.49	121	76184	236259	63176458
Nasal discomfort	59.83	11.49	48	76257	4712	63408005
Dysphonia	59.76	11.49	158	76147	47456	63365261
Anosmia	59.54	11.49	56	76249	6804	63405913
Headache	57.98	11.49	1075	75230	632166	62780551
Therapeutic product effect decreased	57.02	11.49	90	76215	193097	63219620
Overdose	56.67	11.49	34	76271	115044	63297673
Anaemia	56.66	11.49	173	76132	293257	63119460
Drug interaction	55.86	11.49	120	76185	229011	63183706
Folliculitis	55.39	11.49	9	76296	70308	63342409
Impaired healing	55.31	11.49	27	76278	102515	63310202
Rhinorrhoea	55.20	11.49	189	76116	65388	63347329
Upper-airway cough syndrome	54.57	11.49	68	76237	11350	63401367
Bronchitis	54.51	11.49	295	76010	124640	63288077
Loss of personal independence in daily activities	54.00	11.49	246	76059	97044	63315673
Wrong technique in device usage process	53.32	11.49	40	76265	3558	63409159
Prolonged expiration	52.87	11.49	26	76279	1070	63411647
Heart sounds	52.18	11.49	25	76280	971	63411746
Urinary tract discomfort	51.90	11.49	22	76283	638	63412079
Total lung capacity decreased	50.67	11.49	32	76273	2151	63410566
Leukopenia	50.58	11.49	15	76290	77275	63335442
Middle insomnia	49.11	11.49	68	76237	12575	63400142
Poor quality product administered	48.81	11.49	36	76269	3120	63409597
Pancytopenia	48.63	11.49	28	76277	96905	63315812
Hypotension	48.26	11.49	167	76138	272437	63140280
Dermatitis atopic	48.23	11.49	59	76246	9665	63403052
Chronic obstructive pulmonary disease	47.05	11.49	174	76131	62512	63350205
Sinus pain	46.33	11.49	36	76269	3374	63409343
Osteosclerosis	46.32	11.49	38	76267	3850	63408867
Occupational asthma	46.22	11.49	14	76291	146	63412571
Dry eye	45.90	11.49	130	76175	40631	63372086
Alveolar osteitis	45.34	11.49	22	76283	879	63411838
Multiple organ dysfunction syndrome	45.30	11.49	7	76298	56745	63355972
Oropharyngeal pain	45.27	11.49	229	76076	94258	63318459
Bronchial obstruction	45.08	11.49	26	76279	1481	63411236
Cardiac arrest	44.65	11.49	28	76277	92517	63320200
Tunnel vision	44.63	11.49	24	76281	1192	63411525
Irritable bowel syndrome	43.99	11.49	22	76283	82390	63330327
Forced expiratory volume decreased	43.97	11.49	41	76264	4927	63407790
Febrile neutropenia	43.33	11.49	47	76258	118402	63294315
Cardiac murmur	43.21	11.49	69	76236	14483	63398234
Diarrhoea	42.94	11.49	604	75701	714762	62697955
Hepatic enzyme increased	42.92	11.49	114	76191	202214	63210503
Pain	41.78	11.49	633	75672	739995	62672722
Platelet count decreased	41.47	11.49	47	76258	116075	63296642
Hyponatraemia	41.38	11.49	44	76261	111856	63300861
Intentional product use issue	41.23	11.49	56	76249	127836	63284881
Animal scratch	41.19	11.49	24	76281	1394	63411323
Condition aggravated	40.99	11.49	299	76006	401918	63010799
Liver injury	40.98	11.49	11	76294	60509	63352208
Eosinophilic granulomatosis with polyangiitis	40.82	11.49	28	76277	2164	63410553
Product odour abnormal	40.48	11.49	23	76282	1273	63411444
Hyperkalaemia	38.35	11.49	9	76296	54194	63358523
Disease progression	37.34	11.49	56	76249	122702	63290015
Somnolence	37.31	11.49	353	75952	178332	63234385
Metabolic acidosis	37.27	11.49	5	76300	45064	63367653
Oesophageal dilatation	37.05	11.49	15	76290	386	63412331
Asthenopia	36.92	11.49	27	76278	2310	63410407
Dehydration	36.51	11.49	98	76207	173256	63239461
Swelling face	36.34	11.49	162	76143	63313	63349404
Sleep disorder	35.83	11.49	193	76112	81373	63331344
C-reactive protein increased	35.29	11.49	37	76268	94670	63318047
Respiration abnormal	35.22	11.49	41	76264	6376	63406341
Therapy non-responder	35.21	11.49	24	76281	75877	63336840
Ear congestion	35.06	11.49	28	76277	2731	63409986
Mucosal inflammation	34.81	11.49	7	76298	46921	63365796
Swollen tongue	34.43	11.49	106	76199	34694	63378023
Respiratory tract congestion	34.30	11.49	70	76235	17762	63394955
Exposure during pregnancy	34.24	11.49	86	76219	155461	63257256
Drug intolerance	33.61	11.49	225	76080	308436	63104281
Cardio-respiratory arrest	33.54	11.49	15	76290	59944	63352773
Hip arthroplasty	33.53	11.49	8	76297	47638	63365079
Neutrophil count decreased	33.34	11.49	13	76292	56393	63356324
Eczema	32.54	11.49	99	76206	32192	63380525
Palpitations	32.18	11.49	239	76066	112531	63300186
Seasonal allergy	32.06	11.49	75	76230	20875	63391842
Upper respiratory tract infection	31.97	11.49	188	76117	81859	63330858
Nasal mucosal disorder	31.54	11.49	14	76291	455	63412262
Expired product administered	31.46	11.49	38	76267	6143	63406574
White blood cell count decreased	31.32	11.49	76	76229	139028	63273689
Paranasal sinus discomfort	31.05	11.49	32	76273	4344	63408373
Circumstance or information capable of leading to device use error	31.02	11.49	10	76295	130	63412587
Incorrect dose administered by product	30.98	11.49	11	76294	195	63412522
Bladder pain	30.56	11.49	24	76281	2284	63410433
Drug ineffective	30.56	11.49	991	75314	1043774	62368943
Decreased appetite	30.42	11.49	177	76128	250875	63161842
Lactic acidosis	29.93	11.49	5	76300	38282	63374435
Peripheral swelling	29.88	11.49	192	76113	265750	63146967
Skin lesion	29.86	11.49	93	76212	30628	63382089
Septic shock	29.68	11.49	22	76283	66607	63346110
Knee arthroplasty	29.64	11.49	14	76291	54192	63358525
Blood potassium increased	29.62	11.49	67	76238	18242	63394475
Inappropriate schedule of product administration	29.47	11.49	220	76085	103745	63308972
Hypomania	29.14	11.49	37	76268	6293	63406424
Pre-existing condition improved	28.58	11.49	42	76263	8202	63404515
Rheumatoid arthritis	28.13	11.49	184	76121	253635	63159082
Skin weeping	28.02	11.49	15	76290	738	63411979
Haemoptysis	27.95	11.49	87	76218	28639	63384078
Female sterilisation	27.92	11.49	14	76291	601	63412116
CFTR gene mutation	27.92	11.49	9	76296	117	63412600
Sepsis	27.61	11.49	93	76212	153030	63259687
Renal failure	27.51	11.49	63	76242	117589	63295128
Product use issue	26.97	11.49	155	76150	220365	63192352
Dyspnoea exertional	26.69	11.49	143	76162	60159	63352558
Epistaxis	26.65	11.49	164	76141	72561	63340156
Pulmonary function test decreased	26.46	11.49	28	76277	3919	63408798
Red blood cell sedimentation rate increased	26.22	11.49	10	76295	43972	63368745
Acquired haemophilia	26.17	11.49	16	76289	1015	63411702
Suicide attempt	26.01	11.49	21	76284	60897	63351820
Anxiety	25.93	11.49	386	75919	217155	63195562
Lung perforation	25.87	11.49	8	76297	90	63412627
Rash	25.82	11.49	497	75808	560374	62852343
Cholelithiasis	25.81	11.49	113	76192	43812	63368905
Interstitial lung disease	25.62	11.49	22	76283	61886	63350831
Blister	25.40	11.49	76	76229	129738	63282979
Throat irritation	25.37	11.49	101	76204	37546	63375171
Adrenal suppression	25.16	11.49	15	76290	909	63411808
Product quality control issue	25.14	11.49	6	76299	22	63412695
Jaundice cholestatic	24.94	11.49	37	76268	7287	63405430
Painful respiration	24.76	11.49	23	76282	2751	63409966
Blood calcium increased	24.62	11.49	42	76263	9308	63403409
Nasal disorder	24.13	11.49	23	76282	2841	63409876
Glaucoma	23.98	11.49	63	76242	18842	63393875
Treatment failure	23.75	11.49	141	76164	198902	63213815
Product availability issue	23.75	11.49	27	76278	4094	63408623
Electrocardiogram QT prolonged	23.62	11.49	22	76283	59508	63353209
Respiratory tract infection	23.08	11.49	105	76200	41378	63371339
Fibromyalgia	22.68	11.49	170	76135	80250	63332467
Exposure to allergen	22.67	11.49	10	76295	320	63412397
Encephalopathy	22.66	11.49	9	76296	38611	63374106
Sinus congestion	22.59	11.49	60	76245	18063	63394654
Pneumonia	22.55	11.49	713	75592	456054	62956663
Delirium	22.11	11.49	17	76288	50524	63362193
Ureteral disorder	21.97	11.49	10	76295	345	63412372
Diaphragmatic rupture	21.49	11.49	9	76296	253	63412464
Wound secretion	21.29	11.49	27	76278	4587	63408130
Skin fragility	20.96	11.49	12	76293	674	63412043
Malignant neoplasm progression	20.84	11.49	42	76263	82079	63330638
Vital capacity decreased	20.82	11.49	17	76288	1711	63411006
Croup infectious	20.65	11.49	11	76294	536	63412181
Obstruction	20.64	11.49	22	76283	3105	63409612
Hypophagia	20.57	11.49	6	76299	31253	63381464
Depressive symptom	20.52	11.49	25	76280	4077	63408640
Product dosage form issue	20.22	11.49	5	76300	22	63412695
Aspiration	20.17	11.49	42	76263	10809	63401908
Haemoglobin decreased	20.15	11.49	98	76207	145387	63267330
Adiposis dolorosa	19.95	11.49	9	76296	304	63412413
Fatigue	19.94	11.49	869	75436	887159	62525558
Arthralgia	19.91	11.49	527	75778	569183	62843534
Nasal dryness	19.87	11.49	26	76279	4555	63408162
International normalised ratio increased	19.82	11.49	16	76289	46409	63366308
Hepatic failure	19.82	11.49	9	76296	35647	63377070
Gastrointestinal haemorrhage	19.35	11.49	43	76262	81133	63331584
Enthesopathy	19.22	11.49	36	76269	8578	63404139
Perfume sensitivity	19.18	11.49	12	76293	793	63411924
Psoriatic arthropathy	19.06	11.49	52	76253	91468	63321249
Fall	18.85	11.49	345	75960	391989	63020728
Skin burning sensation	18.84	11.49	45	76260	12689	63400028
Polymyalgia rheumatica	18.80	11.49	23	76282	3768	63408949
Lung neoplasm malignant	18.68	11.49	59	76246	19574	63393143
Sneezing	18.49	11.49	56	76249	18162	63394555
Periodic limb movement disorder	18.43	11.49	8	76297	246	63412471
Prescribed overdose	18.40	11.49	9	76296	34144	63378573
Exposure to fungus	18.23	11.49	7	76298	156	63412561
Flail chest	18.20	11.49	6	76299	84	63412633
Illness	18.20	11.49	111	76194	48948	63363769
Migraine	18.11	11.49	197	76108	103149	63309568
Drug reaction with eosinophilia and systemic symptoms	18.10	11.49	9	76296	33827	63378890
Angioedema	18.10	11.49	109	76196	47856	63364861
Deformity	18.06	11.49	42	76263	11642	63401075
Hippocampal sclerosis	17.89	11.49	6	76299	89	63412628
Stomatitis	17.77	11.49	96	76209	138629	63274088
Increased upper airway secretion	17.76	11.49	22	76283	3650	63409067
Purpura senile	17.61	11.49	10	76295	553	63412164
Cardiac failure	17.57	11.49	52	76253	89090	63323627
Tarsal tunnel syndrome	17.43	11.49	10	76295	564	63412153
Wound complication	17.40	11.49	22	76283	3725	63408992
Eosinophil count abnormal	17.21	11.49	10	76295	578	63412139
Ulcer	17.20	11.49	5	76300	26102	63386615
Sedation	17.04	11.49	13	76292	38796	63373921
Drug-induced liver injury	17	11.49	14	76291	40208	63372509
Intentional self-injury	16.78	11.49	5	76300	25682	63387035
Schizophrenia	16.75	11.49	37	76268	9915	63402802
Live birth	16.72	11.49	5	76300	25625	63387092
Erythema marginatum	16.48	11.49	4	76301	16	63412701
Body temperature abnormal	16.46	11.49	16	76289	2025	63410692
Depressed level of consciousness	16.40	11.49	31	76274	62047	63350670
Shock	16.39	11.49	4	76301	23459	63389258
Nasal oedema	16.32	11.49	14	76291	1508	63411209
Bronchitis chronic	16.29	11.49	23	76282	4330	63408387
Product leakage	16.27	11.49	11	76294	830	63411887
Exercise tolerance decreased	16.23	11.49	26	76279	5471	63407246
Hypocalcaemia	16.13	11.49	9	76296	31704	63381013
Bronchial irritation	16.10	11.49	4	76301	18	63412699
Paranasal sinus inflammation	16.04	11.49	9	76296	486	63412231
Joint stiffness	16.00	11.49	16	76289	41853	63370864
Dystrophic calcification	15.87	11.49	6	76299	128	63412589
Cytomegalovirus infection	15.80	11.49	3	76302	20949	63391768
Accident	15.75	11.49	27	76278	6005	63406712
Post-traumatic stress disorder	15.73	11.49	25	76280	5226	63407491
Bradycardia	15.71	11.49	41	76264	73186	63339531
Sleep disorder due to general medical condition, insomnia type	15.70	11.49	24	76281	52193	63360524
Hypertension	15.65	11.49	443	75862	278860	63133857
Hepatic function abnormal	15.61	11.49	13	76292	37129	63375588
Anaphylactic reaction	15.52	11.49	134	76171	65966	63346751
Calculus urinary	15.39	11.49	13	76292	1371	63411346
Tongue pruritus	15.35	11.49	9	76296	529	63412188
Urticaria	15.24	11.49	282	76023	165520	63247197
Neoplasm progression	15.00	11.49	13	76292	36415	63376302
Genital rash	14.95	11.49	9	76296	555	63412162
Heart rate increased	14.87	11.49	176	76129	94062	63318655
Hospitalisation	14.82	11.49	162	76143	84919	63327798
Temporal lobe epilepsy	14.77	11.49	8	76297	403	63412314
Focal segmental glomerulosclerosis	14.73	11.49	13	76292	1455	63411262
Tubulointerstitial nephritis	14.70	11.49	3	76302	19900	63392817
Procedural anxiety	14.66	11.49	10	76295	766	63411951
Breast cancer	14.63	11.49	104	76201	48279	63364438
Exostosis	14.60	11.49	51	76254	17811	63394906
Tenosynovitis	14.56	11.49	43	76262	13752	63398965
Blood immunoglobulin E decreased	14.56	11.49	5	76300	80	63412637
Adrenal insufficiency	14.52	11.49	51	76254	17864	63394853
Bronchial wall thickening	14.49	11.49	13	76292	1486	63411231
Allergy to animal	14.47	11.49	12	76293	1234	63411483
Thoracic operation	14.42	11.49	6	76299	166	63412551
Panic attack	14.32	11.49	59	76246	22272	63390445
Respiratory arrest	14.25	11.49	11	76294	32634	63380083
Asthmatic crisis	14.22	11.49	14	76291	1799	63410918
Pregnancy	14.16	11.49	14	76291	36822	63375895
Hypothalamic pituitary adrenal axis suppression	14.15	11.49	6	76299	174	63412543
Diaphragmatic paralysis	14.12	11.49	9	76296	615	63412102
Haemorrhage	14.00	11.49	33	76272	60989	63351728
Pulmonary mass	13.94	11.49	59	76246	22537	63390180
Hypokalaemia	13.76	11.49	71	76234	103733	63308984
Sputum purulent	13.74	11.49	11	76294	1076	63411641
Device expulsion	13.74	11.49	13	76292	34909	63377808
Hereditary angioedema	13.74	11.49	29	76276	7533	63405184
Atrial fibrillation	13.70	11.49	83	76222	116553	63296164
Foetal exposure during pregnancy	13.66	11.49	11	76294	31951	63380766
Skin wrinkling	13.46	11.49	11	76294	1108	63411609
Rhinitis perennial	13.45	11.49	4	76301	39	63412678
Product administration error	13.45	11.49	58	76247	22339	63390378
Hypomagnesaemia	13.44	11.49	9	76296	28728	63383989
Allergic sinusitis	13.44	11.49	11	76294	1111	63411606
Diabetic ketoacidosis	13.37	11.49	4	76301	20501	63392216
Hypoglycaemia	13.37	11.49	33	76272	60032	63352685
Cerebral infarction	13.33	11.49	6	76299	23887	63388830
Pancreatitis relapsing	13.22	11.49	10	76295	900	63411817
Mesenteric haemorrhage	13.18	11.49	4	76301	42	63412675
Oropharyngeal oedema	13.12	11.49	7	76298	342	63412375
Vestibular disorder	13.03	11.49	12	76293	1419	63411298
Influenza	12.97	11.49	193	76112	108529	63304188
Prescribed underdose	12.97	11.49	10	76295	29679	63383038
Stress urinary incontinence	12.85	11.49	15	76290	2340	63410377
Unresponsive to stimuli	12.83	11.49	13	76292	33803	63378914
Peritoneal perforation	12.64	11.49	5	76300	121	63412596
Chronic sinusitis	12.59	11.49	39	76266	12804	63399913
Fractional exhaled nitric oxide increased	12.36	11.49	3	76302	12	63412705
Dry throat	12.36	11.49	26	76279	6739	63405978
Aphonia	12.22	11.49	33	76272	10030	63402687
Product deposit	12.22	11.49	6	76299	246	63412471
Exposure via skin contact	12.15	11.49	7	76298	398	63412319
Drug eruption	12.11	11.49	10	76295	28684	63384033
Ascites	11.98	11.49	19	76286	40709	63372008
Infusion site pruritus	11.97	11.49	24	76281	6011	63406706
Breast conserving surgery	11.97	11.49	10	76295	1039	63411678
Infusion site erythema	11.95	11.49	36	76269	11643	63401074
Seizure	11.89	11.49	102	76203	132532	63280185
Intraocular pressure increased	11.86	11.49	24	76281	6054	63406663
Bone hypertrophy	11.85	11.49	7	76298	417	63412300
Product administered to patient of inappropriate age	11.84	11.49	17	76288	3251	63409466
Infusion site swelling	11.83	11.49	32	76273	9738	63402979
Breath sounds absent	11.77	11.49	6	76299	267	63412450
Toxic epidermal necrolysis	11.76	11.49	8	76297	25326	63387391
Ear pain	11.72	11.49	79	76226	36039	63376678
Respiratory failure	11.70	11.49	73	76232	101785	63310932
Metastases to liver	11.61	11.49	7	76298	23632	63389085
Pneumocystis jirovecii pneumonia	11.59	11.49	3	76302	16911	63395806
Rhabdomyolysis	11.56	11.49	22	76283	43929	63368788
Erythema of eyelid	11.55	11.49	14	76291	2272	63410445

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 quality issue	2851.29	12.16	929	32682	16106	34907214
No adverse event	2191.50	12.16	824	32787	22103	34901217
Poor quality device used	1475.43	12.16	306	33305	644	34922676
Product dose omission issue	1062.83	12.16	894	32717	118817	34804503
Asthma	535.74	12.16	392	33219	42264	34881056
Product container issue	423.28	12.16	105	33506	614	34922706
Device malfunction	379.57	12.16	190	33421	10231	34913089
Wheezing	373.37	12.16	313	33298	41089	34882231
Circumstance or information capable of leading to medication error	268.50	12.16	90	33521	1689	34921631
Cough	197.16	12.16	441	33170	149699	34773621
Chest discomfort	196.65	12.16	252	33359	54278	34869042
Obstructive airways disorder	173.26	12.16	133	33478	15361	34907959
Nasal congestion	159.20	12.16	150	33461	22907	34900413
Nasal polyps	158.34	12.16	67	33544	2436	34920884
Dyspnoea	155.89	12.16	744	32867	376038	34547282
Sleep disorder due to a general medical condition	132.90	12.16	75	33536	5146	34918174
Fractional exhaled nitric oxide increased	125.59	12.16	45	33566	1037	34922283
Toxicity to various agents	107.25	12.16	30	33581	200332	34722988
Plantar fasciitis	99.51	12.16	46	33565	2070	34921250
Death	96.86	12.16	146	33465	397903	34525417
Chronic sinusitis	96.25	12.16	46	33565	2233	34921087
Sensation of foreign body	93.28	12.16	48	33563	2735	34920585
Full blood count abnormal	91.54	12.16	101	33510	18567	34904753
Infective pulmonary exacerbation of cystic fibrosis	90.87	12.16	65	33546	6736	34916584
Sinusitis	87.65	12.16	149	33462	41253	34882067
Acute kidney injury	87.31	12.16	99	33512	304889	34618431
Myoglobin blood increased	83.97	12.16	46	33565	2977	34920343
Dyspnoea exertional	79.04	12.16	146	33465	43133	34880187
Drug abuse	72.81	12.16	6	33605	99090	34824230
Off label use	72.55	12.16	188	33423	419336	34503984
Rhinitis perennial	71.78	12.16	22	33589	305	34923015
Productive cough	70.85	12.16	129	33482	37684	34885636
Neutropenia	67.82	12.16	33	33578	156745	34766575
Upper-airway cough syndrome	66.77	12.16	42	33569	3516	34919804
Completed suicide	66.76	12.16	8	33603	98160	34825160
Secretion discharge	66.67	12.16	51	33560	5854	34917466
Steroid withdrawal syndrome	64.58	12.16	19	33592	227	34923093
Brain natriuretic peptide increased	61.97	12.16	48	33563	5611	34917709
Nasopharyngitis	61.68	12.16	177	33434	69791	34853529
Nasal discomfort	60.17	12.16	30	33581	1598	34921722
Anosmia	59.67	12.16	41	33570	3983	34919337
Thrombocytopenia	58.82	12.16	39	33572	156208	34767112
Dysphonia	57.39	12.16	90	33521	23293	34900027
Eosinophilic granulomatosis with polyangiitis	57.31	12.16	31	33580	1956	34921364
Exostosis	55.99	12.16	42	33569	4681	34918639
Poor quality product administered	55.69	12.16	30	33581	1877	34921443
Dermatitis atopic	51.38	12.16	42	33569	5305	34918015
Hypersensitivity	50.52	12.16	151	33460	60884	34862436
Dust allergy	49.92	12.16	22	33589	884	34922436
Incorrect dose administered	49.62	12.16	116	33495	40399	34882921
Anaemia	47.96	12.16	95	33516	233240	34690080
Adjustment disorder	46.97	12.16	23	33588	1178	34922142
Underdose	46.96	12.16	62	33549	13718	34909602
Product taste abnormal	44.47	12.16	22	33589	1152	34922168
Forced expiratory volume decreased	43.68	12.16	31	33580	3172	34920148
Rhinorrhoea	43.62	12.16	84	33527	25584	34897736
Painful respiration	43.40	12.16	22	33589	1214	34922106
Bronchopulmonary aspergillosis allergic	43.07	12.16	20	33591	909	34922411
Device dislocation	41.85	12.16	40	33571	6209	34917111
Rhinitis allergic	40.39	12.16	29	33582	3021	34920299
Adrenal suppression	39.86	12.16	17	33594	630	34922690
Obesity	39.42	12.16	55	33556	12823	34910497
Chest injury	38.19	12.16	22	33589	1569	34921751
Bronchial obstruction	37.87	12.16	22	33589	1594	34921726
Sinus polyp	37.80	12.16	12	33599	188	34923132
Pulmonary function test decreased	37.48	12.16	34	33577	4941	34918379
Platelet count decreased	37.36	12.16	36	33575	119681	34803639
Pleural thickening	37.23	12.16	14	33597	371	34922949
Nasal disorder	36.78	12.16	23	33588	1905	34921415
Renal failure	36.56	12.16	43	33568	130514	34792806
Eosinophilia	35.35	12.16	78	33533	26144	34897176
Multiple organ dysfunction syndrome	34.81	12.16	15	33596	76551	34846769
Oropharyngeal discomfort	34.76	12.16	27	33584	3169	34920151
Therapeutic product effect incomplete	34.47	12.16	117	33494	50424	34872896
Allergy to animal	32.87	12.16	13	33598	396	34922924
Hyperkalaemia	32.50	12.16	13	33598	69376	34853944
Walking aid user	31.87	12.16	21	33590	1903	34921417
Hepatic function abnormal	31.72	12.16	3	33608	44360	34878960
Gastrooesophageal reflux disease	31.53	12.16	94	33517	37830	34885490
Febrile neutropenia	31.40	12.16	52	33559	136797	34786523
Disease progression	30.90	12.16	35	33576	108042	34815278
Nasal oedema	30.58	12.16	12	33599	358	34922962
Oropharyngeal pain	30.50	12.16	89	33522	35396	34887924
Middle insomnia	30.26	12.16	35	33576	6767	34916553
Loss of personal independence in daily activities	30.24	12.16	85	33526	33094	34890226
Enterocolitis infectious	29.30	12.16	19	33592	1676	34921644
Eczema	28.50	12.16	58	33553	18378	34904942
Bradycardia	28.11	12.16	19	33592	75399	34847921
Malignant neoplasm progression	28.01	12.16	26	33585	88020	34835300
Respiratory tract congestion	28.00	12.16	32	33579	6107	34917213
Drug interaction	27.99	12.16	117	33494	225829	34697491
Tachyarrhythmia	27.85	12.16	25	33586	3583	34919737
Bronchial wall thickening	27.82	12.16	17	33594	1351	34921969
Seasonal allergy	27.46	12.16	33	33578	6642	34916678
Pancytopenia	27.00	12.16	31	33580	95126	34828194
Sleep apnoea syndrome	26.88	12.16	60	33551	20261	34903059
General physical health deterioration	26.50	12.16	52	33559	128217	34795103
Influenza	26.33	12.16	106	33505	49560	34873760
Throat irritation	26.32	12.16	41	33570	10544	34912776
Hypersomnia	25.37	12.16	44	33567	12363	34910957
Product odour abnormal	24.90	12.16	13	33598	763	34922557
Sputum discoloured	24.86	12.16	34	33577	7778	34915542
Cardio-respiratory arrest	24.85	12.16	11	33600	55262	34868058
Oral candidiasis	24.84	12.16	43	33568	12067	34911253
Central obesity	24.72	12.16	12	33599	603	34922717
Skin plaque	24.42	12.16	26	33585	4588	34918732
Tongue dry	24.20	12.16	9	33602	231	34923089
Increased viscosity of upper respiratory secretion	24.12	12.16	8	33603	145	34923175
Chorioretinopathy	24.02	12.16	16	33595	1477	34921843
Product quality control issue	23.79	12.16	4	33607	0	34923320
Hypotension	23.75	12.16	121	33490	221528	34701792
Sneezing	23.36	12.16	27	33584	5215	34918105
Ear infection	23.20	12.16	38	33573	10193	34913127
Septic shock	23.10	12.16	21	33590	71813	34851507
Pyrexia	23.09	12.16	207	33404	332806	34590514
Sepsis	22.68	12.16	83	33528	166478	34756842
Hot flush	22.41	12.16	52	33559	18014	34905306
Rhinitis	22.34	12.16	29	33582	6309	34917011
Aortic aneurysm	22.33	12.16	30	33581	6749	34916571
Leukopenia	21.90	12.16	17	33594	62839	34860481
Renal impairment	21.59	12.16	36	33575	94477	34828843
Wrong technique in device usage process	21.47	12.16	15	33596	1497	34921823
Encephalopathy	21.42	12.16	4	33607	35315	34888005
Cardiac disorder	21.25	12.16	90	33521	43036	34880284
Eosinophilic bronchitis	21.14	12.16	8	33603	216	34923104
Exercise lack of	20.99	12.16	7	33604	129	34923191
Feeling cold	20.81	12.16	37	33574	10602	34912718
Discomfort	20.79	12.16	52	33559	18886	34904434
Metabolic acidosis	20.75	12.16	8	33603	43672	34879648
Mast cell activation syndrome	20.28	12.16	8	33603	242	34923078
Bronchitis	20.23	12.16	87	33524	41876	34881444
Headache	20.06	12.16	287	33324	200348	34722972
Blood creatinine increased	20.04	12.16	38	33573	94938	34828382
Interstitial lung disease	19.92	12.16	20	33591	65262	34858058
Ascites	19.81	12.16	10	33601	46561	34876759
Somnolence	19.69	12.16	49	33562	111067	34812253
Maple syrup disease	19.41	12.16	4	33607	8	34923312
Temperature intolerance	19.39	12.16	20	33591	3402	34919918
Dry skin	19.23	12.16	70	33541	31217	34892103
Incorrect dose administered by product	19.02	12.16	5	33606	38	34923282
Fungal disease carrier	18.95	12.16	8	33603	289	34923031
Diarrhoea	18.85	12.16	263	33348	389649	34533671
Bronchiolitis	18.79	12.16	19	33592	3157	34920163
Growth retardation	18.78	12.16	15	33596	1833	34921487
Product availability issue	18.50	12.16	15	33596	1872	34921448
Cockroach allergy	18.47	12.16	5	33606	43	34923277
Confusional state	18.23	12.16	74	33537	144086	34779234
Sitting disability	18.22	12.16	7	33604	197	34923123
Cardiac arrest	18.16	12.16	41	33570	96118	34827202
Cystic fibrosis	18.01	12.16	14	33597	1644	34921676
Respiratory arrest	17.38	12.16	3	33608	28040	34895280
Gastrointestinal haemorrhage	17.30	12.16	37	33574	88440	34834880
Skin atrophy	17.12	12.16	15	33596	2082	34921238
Sleep disorder	17.08	12.16	68	33543	31620	34891700
Sinus disorder	17.00	12.16	27	33584	7058	34916262
Crepitations	16.90	12.16	18	33593	3178	34920142
Conjunctivitis	16.77	12.16	32	33579	9673	34913647
Myocardial infarction	16.70	12.16	60	33551	121025	34802295
Cataract	16.44	12.16	59	33552	26127	34897193
Papillary renal cell carcinoma	16.37	12.16	7	33604	261	34923059
Coma	16.37	12.16	12	33599	45666	34877654
Transaminases increased	16.34	12.16	3	33608	26820	34896500
Intentional overdose	16.27	12.16	11	33600	43663	34879657
Expired product administered	16.24	12.16	18	33593	3323	34919997
Snoring	16.21	12.16	18	33593	3328	34919992
C-reactive protein increased	16.02	12.16	17	33594	54081	34869239
Ear disorder	15.66	12.16	13	33598	1677	34921643
Bronchial irritation	15.63	12.16	4	33607	27	34923293
Hepatic failure	15.32	12.16	7	33604	34524	34888796
Pleural effusion	15.21	12.16	35	33576	81511	34841809
Rhabdomyolysis	14.62	12.16	27	33584	68136	34855184
Cholestasis	14.44	12.16	4	33607	26944	34896376
Aspartate aminotransferase increased	14.40	12.16	27	33584	67756	34855564
Dyspnoea at rest	14.26	12.16	18	33593	3810	34919510
Chronic obstructive pulmonary disease	14.19	12.16	88	33523	48830	34874490
Bronchiectasis	14.17	12.16	30	33581	9771	34913549
Hyposmia	14.10	12.16	6	33605	221	34923099
Polyp	14.02	12.16	18	33593	3874	34919446
Lactic acidosis	14.00	12.16	8	33603	34764	34888556
Delirium	13.97	12.16	13	33598	43978	34879342
Swollen tongue	13.88	12.16	38	33573	14567	34908753
Cytomegalovirus infection	13.79	12.16	4	33607	26131	34897189
Hyperleukocytosis	13.76	12.16	13	33598	1989	34921331
Pruritus	13.73	12.16	202	33409	141779	34781541
Drug resistance	13.62	12.16	4	33607	25923	34897397
Treatment failure	13.47	12.16	15	33596	46682	34876638
Haemoglobin decreased	13.44	12.16	65	33546	120707	34802613
Blood pressure decreased	13.33	12.16	18	33593	51497	34871823
Lung diffusion disorder	12.97	12.16	5	33606	142	34923178
Hypercholesterolaemia	12.88	12.16	27	33584	8735	34914585
Coronary artery disease	12.84	12.16	85	33526	48220	34875100
International normalised ratio increased	12.79	12.16	16	33595	47311	34876009
Primary familial brain calcification	12.48	12.16	3	33608	15	34923305
Skin weeping	12.31	12.16	7	33604	487	34922833
Haematochezia	12.30	12.16	16	33595	46518	34876802
Sputum abnormal	12.26	12.16	7	33604	491	34922829
Pleuritic pain	12.17	12.16	16	33595	3525	34919795

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 quality issue	2000.33	10.20	882	81655	33058	79628793
Poor quality device used	1994.45	10.20	465	82072	1820	79660031
Asthma	1045.03	10.20	966	81571	134129	79527722
Wheezing	660.01	10.20	704	81833	115960	79545891
No adverse event	644.72	10.20	429	82108	36763	79625088
Product dose omission issue	595.49	10.20	981	81556	246556	79415295
Gastrooesophageal reflux disease	564.84	10.20	615	81922	103631	79558220
Device malfunction	472.75	10.20	288	82249	21160	79640691
Rhinitis allergic	426.15	10.20	222	82315	12047	79649804
Sleep disorder due to a general medical condition	397.29	10.20	223	82314	14054	79647797
Cough	345.66	10.20	995	81542	365794	79296057
Nasal polyps	314.39	10.20	153	82384	7174	79654677
Ejection fraction	307.88	10.20	108	82429	2161	79659690
Circumstance or information capable of leading to medication error	303.34	10.20	124	82413	3824	79658027
Sputum discoloured	297.50	10.20	217	82320	21526	79640325
Polycystic ovaries	294.83	10.20	120	82417	3659	79658192
Sensitisation	292.53	10.20	115	82422	3196	79658655
Dyspnoea	268.47	10.20	1656	80881	855369	78806482
Nasal congestion	257.10	10.20	355	82182	76197	79585654
Productive cough	253.30	10.20	380	82157	87951	79573900
Product container issue	240.59	10.20	78	82459	1213	79660638
Full blood count abnormal	240.54	10.20	251	82286	40223	79621628
Toxicity to various agents	237.20	10.20	71	82466	421469	79240382
Completed suicide	222.60	10.20	7	82530	245760	79416091
Blood test abnormal	220.44	10.20	167	82370	17543	79644308
Obstructive airways disorder	192.15	10.20	198	82339	31261	79630590
Chest discomfort	184.94	10.20	428	82109	137616	79524235
Infective pulmonary exacerbation of cystic fibrosis	184.32	10.20	132	82405	12719	79649132
Acute kidney injury	161.43	10.20	180	82357	519224	79142627
Sleep apnoea syndrome	159.79	10.20	193	82344	36285	79625566
Pleural thickening	154.75	10.20	71	82466	2911	79658940
Death	147.60	10.20	224	82313	566290	79095561
Synovitis	141.30	10.20	3	82534	150731	79511120
Steroid withdrawal syndrome	140.23	10.20	45	82492	676	79661175
Drug abuse	139.28	10.20	7	82530	162684	79499167
Bronchiectasis	138.70	10.20	142	82395	22244	79639607
Presbyacusis	136.99	10.20	63	82474	2597	79659254
Bronchopulmonary aspergillosis allergic	134.57	10.20	65	82472	2996	79658855
Neutropenia	132.67	10.20	66	82471	287644	79374207
Carpal tunnel syndrome	130.39	10.20	129	82408	19399	79642452
Headache	118.70	10.20	1113	81424	652659	79009192
Therapeutic product effect incomplete	113.92	10.20	364	82173	141281	79520570
Total lung capacity increased	113.90	10.20	53	82484	2245	79659606
Pleural fibrosis	112.96	10.20	64	82473	4103	79657748
Sinusitis	111.59	10.20	449	82088	195052	79466799
Asthma-chronic obstructive pulmonary disease overlap syndrome	108.17	10.20	57	82480	3164	79658687
Off label use	106.31	10.20	531	82006	906684	78755167
Thrombocytopenia	103.77	10.20	74	82463	265185	79396666
Blood magnesium increased	98.16	10.20	55	82482	3451	79658400
Pneumonia aspiration	97.83	10.20	215	82322	66752	79595099
Loss of personal independence in daily activities	96.91	10.20	279	82258	102301	79559550
Ejection fraction abnormal	95.89	10.20	48	82489	2392	79659459
Eosinophilic granulomatosis with polyangiitis	93.29	10.20	54	82483	3606	79658245
Deafness neurosensory	92.42	10.20	68	82469	6830	79655021
Burning sensation	92.25	10.20	194	82343	58438	79603413
Rhinorrhoea	92.22	10.20	227	82310	75847	79586004
Nephrectomy	90.23	10.20	44	82493	2071	79659780
Nasal discomfort	87.19	10.20	60	82477	5423	79656428
Anaemia	86.04	10.20	210	82327	444805	79217046
Contraindicated product administered	85.83	10.20	28	82509	157510	79504341
Hand deformity	84.30	10.20	6	82531	103913	79557938
Upper-airway cough syndrome	83.22	10.20	80	82457	11613	79650238
Anosmia	81.58	10.20	70	82467	8774	79653077
Sinus disorder	81.16	10.20	108	82429	22356	79639495
Forced expiratory volume decreased	80.66	10.20	66	82471	7748	79654103
Bronchitis	76.05	10.20	302	82235	130342	79531509
Cardiac disorder	75.28	10.20	192	82345	65565	79596286
Middle insomnia	75.27	10.20	88	82449	15981	79645870
Systemic lupus erythematosus	74.49	10.20	17	82520	121132	79540719
Cyst	73.68	10.20	81	82456	13759	79648092
Rhinitis perennial	72.58	10.20	23	82514	331	79661520
Drug interaction	72.56	10.20	206	82331	414977	79246874
Epigastric discomfort	71.82	10.20	62	82475	7834	79654017
General physical health deterioration	70.39	10.20	110	82427	275128	79386723
Dermatitis atopic	70.06	10.20	68	82469	9988	79651863
Sarcoidosis	68.92	10.20	62	82475	8273	79653578
Oropharyngeal pain	68.72	10.20	259	82278	109094	79552757
Product taste abnormal	67.34	10.20	37	82500	2234	79659617
Intentional overdose	66.91	10.20	14	82523	105946	79555905
Bronchial obstruction	65.70	10.20	39	82498	2729	79659122
Pericarditis	65.35	10.20	14	82523	104222	79557629
Glossodynia	64.54	10.20	14	82523	103323	79558528
Multiple organ dysfunction syndrome	64.40	10.20	22	82515	120224	79541627
Platelet count decreased	63.06	10.20	65	82472	194599	79467252
Rales	63.00	10.20	90	82447	19911	79641940
Hyperkalaemia	62.90	10.20	20	82517	114378	79547473
Osteopenia	61.35	10.20	85	82452	18279	79643572
Nasal disorder	59.36	10.20	41	82496	3728	79658123
Overdose	59.11	10.20	62	82475	184144	79477707
Swollen tongue	58.04	10.20	133	82404	42437	79619414
Febrile neutropenia	57.46	10.20	94	82443	230905	79430946
Cardiac arrest	57.41	10.20	56	82481	172040	79489811
Sleep disorder	57.24	10.20	207	82330	85470	79576381
Helicobacter infection	56.60	10.20	4	82533	69700	79592151
Pancytopenia	56.38	10.20	53	82484	165692	79496159
Metabolic acidosis	56.20	10.20	9	82528	82520	79579331
Bone cyst	55.61	10.20	38	82499	3395	79658456
Dry eye	55.55	10.20	120	82417	36811	79625040
Cardiac murmur	55.51	10.20	75	82462	15749	79646102
Eczema	55.07	10.20	127	82410	40691	79621160
Chronic sinusitis	53.92	10.20	67	82470	12959	79648892
Hypothyroidism	53.88	10.20	147	82390	52245	79609606
Adrenal suppression	53.45	10.20	27	82510	1372	79660479
Heart sounds	53.28	10.20	24	82513	942	79660909
Leukopenia	53.24	10.20	27	82510	116486	79545365
Cardio-respiratory arrest	52.89	10.20	23	82514	108487	79553364
Hypotension	52.34	10.20	256	82281	440061	79221790
Swelling face	51.84	10.20	177	82360	71035	79590816
Confusional state	51.76	10.20	163	82374	317834	79344017
Renal disorder	51.39	10.20	126	82411	41979	79619872
Disease progression	50.71	10.20	70	82467	184292	79477559
Osteosclerosis	50.64	10.20	38	82499	3933	79657918
Pulmonary function test decreased	50.15	10.20	50	82487	7587	79654264
Prolonged expiration	49.94	10.20	25	82512	1246	79660605
Rheumatoid factor positive	49.87	10.20	3	82534	59836	79602015
Renal failure	49.77	10.20	82	82455	200886	79460965
Dyspnoea exertional	49.63	10.20	200	82337	86873	79574978
Chronic obstructive pulmonary disease	49.32	10.20	197	82340	85222	79576629
Respiratory tract congestion	49.01	10.20	80	82457	19874	79641977
Rhinitis	48.66	10.20	68	82469	14739	79647112
Incorrect dose administered	48.55	10.20	182	82355	76448	79585403
Dysphonia	48.29	10.20	149	82388	56723	79605128
Wrong technique in device usage process	47.96	10.20	37	82500	3991	79657860
Seasonal allergy	47.57	10.20	71	82466	16335	79645516
Septic shock	47.02	10.20	35	82502	122766	79539085
Asthenopia	46.92	10.20	30	82507	2397	79659454
Total lung capacity decreased	46.69	10.20	32	82505	2873	79658978
Maternal exposure during pregnancy	44.88	10.20	45	82492	136493	79525358
Sepsis	44.61	10.20	137	82400	269291	79392560
C-reactive protein increased	44.18	10.20	41	82496	128986	79532865
Respiration abnormal	43.94	10.20	47	82490	7741	79654110
Nasal mucosal disorder	43.69	10.20	16	82521	364	79661487
Infusion related reaction	43.36	10.20	110	82427	230127	79431724
Skin weeping	42.33	10.20	21	82516	1026	79660825
Wound	42.09	10.20	35	82502	116144	79545707
Lactic acidosis	41.06	10.20	11	82526	70348	79591503
Influenza	40.49	10.20	251	82286	129355	79532496
Hypersensitivity	40.35	10.20	432	82105	261807	79400044
Dust allergy	40.05	10.20	23	82514	1513	79660338
Hyponatraemia	39.17	10.20	78	82459	177770	79484081
Breast cancer	39.03	10.20	99	82438	33682	79628169
Joint swelling	38.96	10.20	160	82377	288486	79373365
Palpitations	38.80	10.20	244	82293	126366	79535485
Bone marrow failure	38.58	10.20	4	82533	51103	79610748
Encephalopathy	38.46	10.20	11	82526	67386	79594465
Urticaria	37.86	10.20	324	82213	184877	79476974
Nasal oedema	37.59	10.20	23	82514	1701	79660150
Painful respiration	37.40	10.20	30	82507	3423	79658428
Throat irritation	37.33	10.20	110	82427	40836	79621015
Nasopharyngitis	37.11	10.20	414	82123	253467	79408384
Mucosal inflammation	36.86	10.20	16	82521	75564	79586287
Tunnel vision	36.85	10.20	22	82515	1556	79660295
Hepatic function abnormal	36.42	10.20	15	82522	73092	79588759
Underdose	36.08	10.20	95	82442	33056	79628795
Interstitial lung disease	36.00	10.20	38	82499	112562	79549289
Bradycardia	34.79	10.20	54	82483	135503	79526348
Alveolar osteitis	34.32	10.20	17	82520	828	79661023
Increased viscosity of upper respiratory secretion	33.87	10.20	13	82524	338	79661513
Urinary tract discomfort	33.38	10.20	16	82521	725	79661126
Sinus pain	33.26	10.20	29	82508	3713	79658138
Therapy non-responder	33.20	10.20	28	82509	92277	79569574
Hepatic failure	33.11	10.20	11	82526	61201	79600650
Fibromyalgia	32.92	10.20	143	82394	64197	79597654
Condition aggravated	32.38	10.20	347	82190	500777	79161074
Sneezing	31.97	10.20	66	82471	19617	79642234
Poor quality product administered	31.90	10.20	28	82509	3617	79658234
Incorrect dose administered by product	31.88	10.20	11	82526	209	79661642
Sinus polyp	31.70	10.20	14	82523	524	79661327
International normalised ratio increased	31.34	10.20	25	82512	84696	79577155
Abdominal discomfort	30.78	10.20	144	82393	250583	79411268
Vomiting	30.58	10.20	495	82042	665333	78996518
Lung opacity	30.57	10.20	32	82505	5142	79656709
Skin plaque	30.44	10.20	46	82491	10699	79651152
Arthropathy	30.06	10.20	89	82448	177022	79484829
Delirium	30.04	10.20	26	82511	84601	79577250
Anxiety	29.24	10.20	389	82148	248123	79413728
Gastrointestinal haemorrhage	29.04	10.20	69	82468	147650	79514201
Hypomania	28.38	10.20	37	82500	7507	79654344
Electrocardiogram QT prolonged	28.34	10.20	31	82506	90355	79571496
Folliculitis	28.17	10.20	11	82526	55369	79606482
Animal scratch	27.95	10.20	18	82519	1456	79660395
Exostosis	27.94	10.20	57	82480	16801	79645050
Dehydration	27.90	10.20	147	82390	248040	79413811
Drug resistance	27.86	10.20	5	82532	42208	79619643
Muscle injury	27.57	10.20	8	82529	48553	79613298
Paranasal sinus discomfort	27.11	10.20	28	82509	4428	79657423
Feeling cold	26.97	10.20	78	82459	28651	79633200
Product odour abnormal	26.95	10.20	17	82520	1327	79660524
Swelling	26.87	10.20	124	82413	216587	79445264
Respiratory arrest	26.79	10.20	13	82524	57537	79604314
Impaired healing	26.46	10.20	31	82506	87624	79574227
Cytomegalovirus infection	26.17	10.20	6	82531	42638	79619213
Dry skin	26.01	10.20	139	82398	67856	79593995
Lung perforation	25.92	10.20	8	82529	105	79661746
Ascites	25.87	10.20	24	82513	75538	79586313
CFTR gene mutation	25.85	10.20	8	82529	106	79661745
Sinus congestion	25.85	10.20	61	82476	19835	79642016
Diarrhoea	25.61	10.20	705	81832	879784	78782067
Cardiogenic shock	25.52	10.20	6	82531	41908	79619943
Neutrophil count decreased	25.50	10.20	36	82501	93923	79567928
Coma	25.46	10.20	185	82352	100464	79561387
Suicide attempt	25.39	10.20	29	82508	82903	79578948
Product administered to patient of inappropriate age	25.32	10.20	30	82507	5523	79656328
Drug reaction with eosinophilia and systemic symptoms	24.99	10.20	18	82519	64226	79597625
Malignant neoplasm progression	24.80	10.20	66	82471	135924	79525927
Cystic fibrosis	24.73	10.20	25	82512	3855	79657996
Ear congestion	24.70	10.20	22	82515	2897	79658954
Intentional product use issue	24.70	10.20	78	82459	152034	79509817
Skin burning sensation	24.56	10.20	47	82490	13225	79648626
Bronchial wall thickening	24.55	10.20	21	82516	2620	79659231
Hypomagnesaemia	24.39	10.20	9	82528	46902	79614949
White blood cell count decreased	24.38	10.20	106	82431	188182	79473669
Croup infectious	24.32	10.20	13	82524	743	79661108
Skin fragility	24.29	10.20	14	82523	927	79660924
Toxic epidermal necrolysis	24.13	10.20	8	82529	44573	79617278
Myelosuppression	24.08	10.20	6	82531	40290	79621561
Diaphragmatic rupture	23.89	10.20	9	82528	222	79661629
Exposure to allergen	23.79	10.20	10	82527	331	79661520
Skin lesion	23.74	10.20	96	82441	41748	79620103
Growth retardation	23.46	10.20	18	82519	1925	79659926
Neurotoxicity	23.41	10.20	3	82534	32515	79629336
Migraine	23.40	10.20	163	82374	87330	79574521
Chest injury	23.36	10.20	21	82516	2800	79659051
Upper respiratory tract infection	23.30	10.20	168	82369	91000	79570851
Shock	23.25	10.20	8	82529	43540	79618311
Deformity	22.90	10.20	38	82499	9567	79652284
Rhabdomyolysis	22.90	10.20	45	82492	103086	79558765
Hospitalisation	22.58	10.20	171	82366	94065	79567786
Haemoglobin decreased	22.55	10.20	136	82401	221983	79439868
Perfume sensitivity	22.48	10.20	13	82524	866	79660985
Jaundice cholestatic	22.17	10.20	41	82496	11243	79650608
Disseminated intravascular coagulation	22.08	10.20	5	82532	35837	79626014
Type 2 diabetes mellitus	22.00	10.20	117	82420	57005	79604846
Blood calcium increased	21.98	10.20	39	82498	10361	79651490
Cardiac failure	21.39	10.20	85	82452	154757	79507094
Therapeutic product effect decreased	21.37	10.20	92	82445	163771	79498080
Depressed mood	21.27	10.20	103	82434	48377	79613474
Illness	21.26	10.20	100	82437	46411	79615440
Adiposis dolorosa	21.24	10.20	9	82528	304	79661547
Product availability issue	20.83	10.20	23	82514	3924	79657927
Central obesity	20.58	10.20	16	82521	1745	79660106
Red blood cell sedimentation rate increased	20.46	10.20	11	82526	45931	79615920
Hepatocellular injury	20.32	10.20	12	82525	47581	79614270
Alopecia	20.30	10.20	148	82389	231207	79430644
Altered state of consciousness	20.24	10.20	10	82527	43812	79618039
Oral candidiasis	20.13	10.20	72	82465	29556	79632295
Hip arthroplasty	20.10	10.20	6	82531	35750	79626101
Temperature intolerance	20.00	10.20	36	82501	9669	79652182
Hypokalaemia	19.94	10.20	79	82458	143961	79517890
Skin atrophy	19.90	10.20	27	82510	5691	79656160
Irritable bowel syndrome	19.89	10.20	21	82516	62220	79599631
Cognitive disorder	19.77	10.20	26	82511	69900	79591951
Blood potassium increased	19.77	10.20	71	82466	29204	79632647
Nasal dryness	19.74	10.20	24	82513	4539	79657312
Respiratory tract infection	19.63	10.20	101	82436	48588	79613263
Pyrexia	19.55	10.20	544	81993	678165	78983686
Acquired haemophilia	19.43	10.20	16	82521	1895	79659956
Liver injury	19.36	10.20	18	82519	56596	79605255
Oropharyngeal discomfort	19.34	10.20	30	82507	7136	79654715
Exposure during pregnancy	19.27	10.20	48	82489	101084	79560767
Lacrimation increased	19.18	10.20	59	82478	22418	79639433
Maple syrup disease	19.11	10.20	4	82533	8	79661843
Depressed level of consciousness	19.11	10.20	45	82492	96607	79565244
Adjustment disorder	18.89	10.20	22	82515	3978	79657873
Ureteral disorder	18.84	10.20	10	82527	563	79661288
Stress	18.81	10.20	144	82393	79468	79582383
Tubulointerstitial nephritis	18.79	10.20	8	82529	38227	79623624
Skin wrinkling	18.52	10.20	13	82524	1213	79660638
Device dislocation	18.41	10.20	64	82473	25906	79635945
Drug level increased	18.39	10.20	9	82528	39642	79622209
Adrenal insufficiency	18.32	10.20	68	82469	28419	79633432
Hereditary angioedema	18.28	10.20	25	82512	5310	79656541
Flail chest	18.18	10.20	6	82531	99	79661752
Cockroach allergy	18.07	10.20	6	82531	101	79661750
Decreased appetite	17.94	10.20	248	82289	342170	79319681
Acute myeloid leukaemia	17.70	10.20	5	82532	30880	79630971
Blood immunoglobulin E decreased	17.69	10.20	6	82531	108	79661743
Cerebral infarction	17.50	10.20	13	82524	45663	79616188
Panic attack	17.45	10.20	60	82477	24156	79637695
Cholestasis	17.32	10.20	17	82520	52092	79609759
Drug-induced liver injury	17.28	10.20	26	82511	66091	79595760
Epistaxis	17.26	10.20	184	82353	111331	79550520
Bronchial irritation	17.09	10.20	5	82532	54	79661797
Erythema marginatum	17.08	10.20	4	82533	16	79661835
Neoplasm progression	17.01	10.20	17	82520	51665	79610186
Hypoacusis	16.97	10.20	69	82468	30081	79631770
Purpura senile	16.73	10.20	9	82528	521	79661330
Polymyalgia rheumatica	16.67	10.20	22	82515	4515	79657336
Allergy to animal	16.66	10.20	13	82524	1426	79660425
Bladder pain	16.65	10.20	16	82521	2321	79659530
Tarsal tunnel syndrome	16.63	10.20	9	82528	527	79661324
Dystrophic calcification	16.53	10.20	6	82531	133	79661718
Increased upper airway secretion	16.52	10.20	21	82516	4156	79657695
Hypersomnia	16.46	10.20	57	82480	23029	79638822
Pulmonary eosinophilia	16.45	10.20	10	82527	731	79661120
Dry throat	16.41	10.20	29	82508	7677	79654174
Procedural anxiety	16.14	10.20	10	82527	756	79661095
Tongue pruritus	16.12	10.20	9	82528	561	79661290
Hyperbilirubinaemia	15.97	10.20	3	82534	24515	79637336
Haemoptysis	15.97	10.20	106	82431	55893	79605958
Genital rash	15.76	10.20	11	82526	1017	79660834
Orthostatic hypotension	15.76	10.20	21	82516	56143	79605708
Aortic aneurysm	15.74	10.20	30	82507	8416	79653435
Respiratory failure	15.73	10.20	116	82421	180795	79481056
Papillary renal cell carcinoma	15.70	10.20	7	82530	268	79661583
Eosinophil count increased	15.63	10.20	46	82491	17059	79644792
Expired product administered	15.62	10.20	27	82510	7024	79654827
Blood pressure increased	15.50	10.20	306	82231	211054	79450797
Tumour lysis syndrome	15.45	10.20	3	82534	23936	79637915
Chorioretinopathy	15.38	10.20	15	82522	2216	79659635
Acute hepatic failure	15.29	10.20	6	82531	30107	79631744
Burns third degree	15.03	10.20	8	82529	453	79661398
Sedation	14.98	10.20	19	82518	51876	79609975
Skin exfoliation	14.93	10.20	103	82434	54997	79606854
Osteoarthritis	14.91	10.20	147	82390	87162	79574689
Psoriatic arthropathy	14.88	10.20	37	82500	77962	79583889
Depressive symptom	14.76	10.20	25	82512	6398	79655453
Lower respiratory tract infection	14.65	10.20	201	82336	129019	79532832
Cholelithiasis	14.60	10.20	99	82438	52565	79609286
Tachyarrhythmia	14.57	10.20	26	82511	6936	79654915
Ear pain	14.54	10.20	70	82467	32799	79629052
Hepatic enzyme increased	14.52	10.20	120	82417	182490	79479361
Fall	14.49	10.20	389	82148	487240	79174611
Renal tubular necrosis	14.45	10.20	4	82533	25035	79636816
Neutropenic sepsis	14.40	10.20	5	82532	27059	79634792
Hypothalamic pituitary adrenal axis suppression	14.38	10.20	7	82530	328	79661523
Secretion discharge	14.31	10.20	41	82496	14981	79646870
Ear infection	14.28	10.20	72	82465	34360	79627491
Circulatory collapse	14.07	10.20	11	82526	37657	79624194
Myalgia	14.03	10.20	270	82267	185371	79476480
Fungal disease carrier	13.98	10.20	7	82530	349	79661502
Insomnia	13.87	10.20	342	82195	244828	79417023
Cushing's syndrome	13.76	10.20	10	82527	985	79660866
Thoracic operation	13.68	10.20	6	82531	221	79661630
Blood immunoglobulin E increased	13.66	10.20	23	82514	5859	79655992
Haematochezia	13.49	10.20	46	82491	87599	79574252
Obstruction	13.44	10.20	20	82517	4590	79657261
Breast conserving surgery	13.41	10.20	9	82528	781	79661070
Enthesopathy	13.39	10.20	34	82503	11574	79650277
Knee arthroplasty	13.37	10.20	15	82522	43233	79618618
Pneumonia	13.32	10.20	822	81715	659424	79002427
Sitting disability	13.26	10.20	7	82530	390	79661461
Respiratory depression	13.23	10.20	6	82531	27624	79634227
Rash macular	13.11	10.20	62	82475	28837	79633014
Forced expiratory volume abnormal	13.10	10.20	5	82532	128	79661723
Prescribed overdose	13.01	10.20	12	82525	37871	79623980
Pulmonary mass	12.96	10.20	62	82475	28972	79632879
Pruritus	12.89	10.20	515	82022	394133	79267718
Cytokine release syndrome	12.84	10.20	11	82526	35987	79625864
Hepatic cytolysis	12.84	10.20	6	82531	27145	79634706
Exposure to fungus	12.82	10.20	5	82532	136	79661715
Body temperature abnormal	12.81	10.20	14	82523	2361	79659490
Hypertension	12.76	10.20	440	82097	330552	79331299
Intentional self-injury	12.71	10.20	9	82528	32410	79629441
Allergic sinusitis	12.65	10.20	9	82528	858	79660993
Appetite disorder	12.62	10.20	26	82511	7713	79654138
Ear disorder	12.62	10.20	18	82519	3975	79657876
Product quality control issue	12.62	10.20	3	82534	13	79661838
Hearing disability	12.59	10.20	4	82533	58	79661793
Post-traumatic stress disorder	12.57	10.20	20	82517	4861	79656990
Hypothermia	12.46	10.20	4	82533	22742	79639109
Multiple allergies	12.44	10.20	31	82506	10429	79651422
Telangiectasia	12.42	10.20	11	82526	1438	79660413
Tongue dry	12.38	10.20	10	82527	1152	79660699
Pharyngeal oedema	12.32	10.20	41	82496	16231	79645620
Urosepsis	12.31	10.20	6	82531	26489	79635362
Primary familial brain calcification	12.26	10.20	3	82534	15	79661836
Breath sounds absent	12.23	10.20	6	82531	286	79661565
Subarachnoid haemorrhage	12.21	10.20	5	82532	24460	79637391
Plasma cell myeloma	12.03	10.20	23	82514	53236	79608615
Increased bronchial secretion	12.02	10.20	16	82521	3311	79658540
Inflammation	11.99	10.20	53	82484	93700	79568151
Eosinophilic bronchitis	11.86	10.20	7	82530	485	79661366
Peritoneal perforation	11.74	10.20	5	82532	171	79661680
Grip strength decreased	11.70	10.20	4	82533	21865	79639986
Aphonia	11.68	10.20	30	82507	10282	79651569
Coagulopathy	11.67	10.20	12	82525	35994	79625857
Seizure	11.66	10.20	132	82405	188702	79473149
Inguinal hernia repair	11.54	10.20	6	82531	324	79661527
Pancreatitis relapsing	11.53	10.20	9	82528	987	79660864
Mesenteric haemorrhage	11.50	10.20	4	82533	78	79661773
Diabetic ketoacidosis	11.49	10.20	11	82526	34111	79627740
Lung neoplasm malignant	11.44	10.20	58	82479	27734	79634117
Eye swelling	11.44	10.20	56	82481	26412	79635439
Eosinophil count abnormal	11.43	10.20	8	82529	743	79661108
Throat tightness	11.32	10.20	58	82479	27849	79634002
Lymphopenia	11.32	10.20	9	82528	30548	79631303
Brain oedema	11.32	10.20	6	82531	25257	79636594
Social fear	11.29	10.20	3	82534	22	79661829
Lung diffusion disorder	11.23	10.20	5	82532	191	79661660
Hot flush	11.19	10.20	96	82441	54781	79607070
Blister	11.17	10.20	75	82462	119401	79542450
Cardiac failure congestive	11.13	10.20	94	82443	142308	79519543
Ventricular fibrillation	11.10	10.20	10	82527	31916	79629935
Aspartate aminotransferase increased	11.07	10.20	91	82446	138550	79523301
Heart rate increased	11.04	10.20	181	82356	120543	79541308
Bronchospasm	11.04	10.20	53	82484	24806	79637045
Nasal polypectomy	10.95	10.20	3	82534	25	79661826
Wrist fracture	10.84	10.20	32	82505	11889	79649962
Bone hypertrophy	10.83	10.20	7	82530	570	79661281
Conjunctivitis	10.82	10.20	54	82483	25661	79636190
Product deposit	10.78	10.20	7	82530	574	79661277
Vestibular disorder	10.76	10.20	13	82524	2442	79659409
Calculus urinary	10.74	10.20	13	82524	2447	79659404
Lichenification	10.68	10.20	8	82529	825	79661026
Menopause	10.67	10.20	12	82525	2090	79659761
Diaphragmatic paralysis	10.66	10.20	9	82528	1103	79660748
Progressive multifocal leukoencephalopathy	10.63	10.20	4	82533	20596	79641255
Dermatitis allergic	10.61	10.20	42	82495	18088	79643763
Bronchiolitis	10.57	10.20	17	82520	4171	79657680
Serotonin syndrome	10.56	10.20	19	82518	45008	79616843
Stomatitis	10.53	10.20	99	82438	146658	79515193
Liver disorder	10.48	10.20	39	82498	72378	79589473
Basal cell carcinoma	10.46	10.20	14	82523	37361	79624490
Hepatic encephalopathy	10.45	10.20	6	82531	24160	79637691
Hypoglycaemia	10.41	10.20	62	82475	101532	79560319
Mental status changes	10.40	10.20	35	82502	66924	79594927
Pneumocystis jirovecii pneumonia	10.35	10.20	11	82526	32497	79629354
Wound secretion	10.34	10.20	21	82516	6167	79655684
Intentional product misuse	10.33	10.20	57	82480	95108	79566743
Accident	10.32	10.20	26	82511	8805	79653046
Obesity	10.32	10.20	67	82470	35058	79626793
Haemodialysis	10.30	10.20	3	82534	18165	79643686
Haemorrhage	10.21	10.20	54	82483	91064	79570787

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	D07AC13	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, potent (group III)
ATC	D07XC03	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, OTHER COMBINATIONS Corticosteroids, potent, other combinations
ATC	R01AD09	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
ATC	R01AD59	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
ATC	R03AK09	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AK14	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AL12	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03BA07	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
MeSH PA	D018926	Anti-Allergic Agents
MeSH PA	D000893	Anti-Inflammatory Agents
MeSH PA	D003879	Dermatologic Agents
CHEBI has role	CHEBI:35472	anti-inflammatory drugs
CHEBI has role	CHEBI:50177	dermatologic agent
CHEBI has role	CHEBI:50857	anti-allergic drugs

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

Disease	Relation	SNOMED_ID	DOID
Atopic dermatitis	indication	24079001	DOID:3310
Contact dermatitis	indication	40275004	DOID:2773
Seborrheic dermatitis	indication	50563003	DOID:8741
Lichen simplex chronicus	indication	53891004
Allergic rhinitis	indication	61582004
Granuloma annulare	indication	65508009	DOID:3777
Pruritus ani	indication	90446007
Asthma	indication	195967001	DOID:2841
Discoid lupus erythematosus	indication	200938002
Plaque psoriasis	indication	200965009
Scalp psoriasis	indication	238608008
Non-allergic asthma	indication	266361008	DOID:9360
Pruritus of genital organs	indication	267802000
Eruption of skin	indication	271807003	DOID:0050486
Allergic asthma	indication	389145006	DOID:9415
Primary cutaneous T-cell lymphoma	indication	400122007
Asthma management	indication	406162001
Allergic Rhinitis Prevention	indication
Chronic Non-Allergic Rhinitis	indication
Severe chronic obstructive pulmonary disease	off-label use	313299006
Mycosis	contraindication	3218000	DOID:1564
Ocular hypertension	contraindication	4210003	DOID:9282
Inactive tuberculosis	contraindication	11999007
Epistaxis	contraindication	12441001
Asthenia	contraindication	13791008
Measles	contraindication	14189004	DOID:8622
Disease caused by parasite	contraindication	17322007
Glaucoma	contraindication	23986001	DOID:1686
Acute tuberculosis	contraindication	25629007
Immunosuppression	contraindication	38013005
Hypertensive disorder	contraindication	38341003	DOID:10763
Varicella	contraindication	38907003	DOID:8659
Hypokalemia	contraindication	43339004
Conduction disorder of the heart	contraindication	44808001
Skin ulcer	contraindication	46742003
Osteoporosis	contraindication	64859006	DOID:11476
Diabetes mellitus	contraindication	73211009	DOID:9351
Hypopituitarism	contraindication	74728003	DOID:9406
Perforation of nasal septum	contraindication	80142000
Bacterial infectious disease	contraindication	87628006
Operation on nose	contraindication	88733004
Thyrotoxicosis	contraindication	90739004	DOID:7997
Fissure in skin	contraindication	95321009
Bilateral cataracts	contraindication	95722004
Prolonged QT interval	contraindication	111975006
Seizure disorder	contraindication	128613002
Ophthalmic herpes simplex	contraindication	186542001
Disease of liver	contraindication	235856003	DOID:409
Telangiectasia disorder	contraindication	247479008
Exacerbation of asthma	contraindication	281239006
Varicella-zoster virus infection	contraindication	309465005
Osteopenia	contraindication	312894000
Skin irritation	contraindication	367466007
Adrenal cortical hypofunction	contraindication	386584007	DOID:10493
Atrophoderma	contraindication	399979006
Peripheral vascular disease	contraindication	400047006
Chronic myocardial ischemia	contraindication	413844008	DOID:3393
Denuded skin	contraindication	418242004
Congenital long QT syndrome	contraindication	442917000
Nasal Septal Ulcers	contraindication
Untreated Fungal Infection	contraindication
Nasal Trauma	contraindication
Nasal Candidiasis	contraindication
Uncontrolled Bacterial Infections	contraindication

🐶 Veterinary Drug Use

Species	Use	Relation
Dogs	Otitis externa	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Mometamax Otic Suspension	Intervet Inc.	3
Posatex Otic Suspension	Intervet Inc.	3
CLARO	Elanco US Inc.	3
Mometavet	Med-Pharmex Inc.	3

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.01	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
1.35MG	SINUVA	INTERSECT ENT INC	N209310	Dec. 8, 2017	RX	IMPLANT	IMPLANTATION	7662141	March 12, 2024	TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG	SINUVA	INTERSECT ENT INC	N209310	Dec. 8, 2017	RX	IMPLANT	IMPLANTATION	7713255	March 12, 2024	TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG	SINUVA	INTERSECT ENT INC	N209310	Dec. 8, 2017	RX	IMPLANT	IMPLANTATION	7951130	March 12, 2024	TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG	SINUVA	INTERSECT ENT INC	N209310	Dec. 8, 2017	RX	IMPLANT	IMPLANTATION	7951131	March 12, 2024	TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG	SINUVA	INTERSECT ENT INC	N209310	Dec. 8, 2017	RX	IMPLANT	IMPLANTATION	7951133	March 12, 2024	TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG	SINUVA	INTERSECT ENT INC	N209310	Dec. 8, 2017	RX	IMPLANT	IMPLANTATION	8109918	March 12, 2024	TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG	SINUVA	INTERSECT ENT INC	N209310	Dec. 8, 2017	RX	IMPLANT	IMPLANTATION	9585681	April 4, 2026	TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG	SINUVA	INTERSECT ENT INC	N209310	Dec. 8, 2017	RX	IMPLANT	IMPLANTATION	7544192	Nov. 29, 2026	TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG	SINUVA	INTERSECT ENT INC	N209310	Dec. 8, 2017	RX	IMPLANT	IMPLANTATION	8025635	June 12, 2027	TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG	SINUVA	INTERSECT ENT INC	N209310	Dec. 8, 2017	RX	IMPLANT	IMPLANTATION	10357640	Oct. 3, 2031	TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
0.025MG/SPRAY;0.665MG/SPRAY	RYALTRIS	GLENMARK SPECIALTY	N211746	Jan. 13, 2022	RX	SPRAY, METERED	NASAL	10016443	Sept. 4, 2034	TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY	RYALTRIS	GLENMARK SPECIALTY	N211746	Jan. 13, 2022	RX	SPRAY, METERED	NASAL	10517880	Sept. 4, 2034	TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY	RYALTRIS	GLENMARK SPECIALTY	N211746	Jan. 13, 2022	RX	SPRAY, METERED	NASAL	10548907	Sept. 4, 2034	TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY	RYALTRIS	GLENMARK SPECIALTY	N211746	Jan. 13, 2022	RX	SPRAY, METERED	NASAL	10646500	Sept. 4, 2034	TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY	RYALTRIS	GLENMARK SPECIALTY	N211746	Jan. 13, 2022	RX	SPRAY, METERED	NASAL	10758550	Sept. 4, 2034	TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE TO A PEDIATRIC PATIENT
0.025MG/SPRAY;0.665MG/SPRAY	RYALTRIS	GLENMARK SPECIALTY	N211746	Jan. 13, 2022	RX	SPRAY, METERED	NASAL	10765686	Sept. 4, 2034	METHOD OF DELIVERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE TO A NASAL AIRWAY
0.025MG/SPRAY;0.665MG/SPRAY	RYALTRIS	GLENMARK SPECIALTY	N211746	Jan. 13, 2022	RX	SPRAY, METERED	NASAL	11400101	Sept. 4, 2034	TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY	RYALTRIS	GLENMARK SPECIALTY	N211746	Jan. 13, 2022	RX	SPRAY, METERED	NASAL	9078923	Sept. 4, 2034	TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY	RYALTRIS	GLENMARK SPECIALTY	N211746	Jan. 13, 2022	RX	SPRAY, METERED	NASAL	9750754	Sept. 4, 2034	TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
1.35MG	SINUVA	INTERSECT ENT INC	N209310	Dec. 8, 2017	RX	IMPLANT	IMPLANTATION	10232152	Nov. 24, 2034	TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.005MG/INH;0.05MG/INH	DULERA	ORGANON LLC	N022518	Aug. 12, 2019	RX	AEROSOL, METERED	INHALATION	Feb. 12, 2023	PEDIATRIC EXCLUSIVITY
0.05MG/INH	ASMANEX HFA	ORGANON LLC	N205641	Aug. 12, 2019	RX	AEROSOL, METERED	INHALATION	Feb. 12, 2023	PEDIATRIC EXCLUSIVITY
0.025MG/SPRAY;0.665MG/SPRAY	RYALTRIS	GLENMARK SPECIALTY	N211746	Jan. 13, 2022	RX	SPRAY, METERED	NASAL	Jan. 13, 2025	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	Ki	9.15	CHEMBL	CHEMBL
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		IC50	6.13	WOMBAT-PK
Progesterone receptor	Nuclear hormone receptor	P06401	PRGR_HUMAN		EC50	9.90	WOMBAT-PK

External reference:

ID	Source
4019844	VUID
N0000147931	NUI
D00690	KEGG_DRUG
4019367	VANDF
4019844	VANDF
4021125	VANDF
C0066700	UMLSCUI
CHEBI:47564	CHEBI
CHEBI:6970	CHEBI
MOF	PDB_CHEM_ID
CHEMBL1161	ChEMBL_ID
D000068656	MESH_DESCRIPTOR_UI
DB14512	DRUGBANK_ID
141646-00-6	SECONDARY_CAS_RN
04201GDN4R	UNII
441336	PUBCHEM_CID
DB00764	DRUGBANK_ID
108118	RXNORM
11404	MMSL
239640	MMSL
5129	MMSL
5130	MMSL
d05262	MMSL
002205	NDDF
395802006	SNOMEDCT_US
395803001	SNOMEDCT_US
395990009	SNOMEDCT_US
75203002	SNOMEDCT_US
C0360564	UMLSCUI
6030	INN_ID
105102-22-5	SECONDARY_CAS_RN
441335	PUBCHEM_CID
9029	IUPHAR_LIGAND_ID
8HR4QJ6DW8	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Dulera	HUMAN PRESCRIPTION DRUG LABEL	2	0085-4610	AEROSOL	200 ug	RESPIRATORY (INHALATION)	NDA	29 sections
Dulera	HUMAN PRESCRIPTION DRUG LABEL	2	0085-7206	AEROSOL	100 ug	RESPIRATORY (INHALATION)	NDA	29 sections
Nasonex	HUMAN OTC DRUG LABEL	1	0113-1720	SPRAY	50 ug	NASAL	NDA	17 sections
Nasonex	HUMAN OTC DRUG LABEL	1	0113-1720	SPRAY	50 ug	NASAL	NDA	17 sections
Childrens Nasonex	HUMAN OTC DRUG LABEL	1	0113-1999	SPRAY	50 ug	NASAL	NDA	17 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0270	CREAM	1 mg	TOPICAL	ANDA	28 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0271	OINTMENT	1 mg	TOPICAL	ANDA	28 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0272	SOLUTION	1 mg	TOPICAL	ANDA	29 sections
allergy nasal	HUMAN OTC DRUG LABEL	1	0363-2060	SPRAY	50 ug	NASAL	NDA	17 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0634	CREAM	1 mg	TOPICAL	ANDA	27 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0634	CREAM	1 mg	TOPICAL	ANDA	27 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0635	OINTMENT	1 mg	TOPICAL	ANDA	24 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0701	SOLUTION	1 mg	TOPICAL	ANDA	27 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0701	SOLUTION	1 mg	TOPICAL	ANDA	27 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0726	CREAM	1 mg	TOPICAL	ANDA	27 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0726	CREAM	1 mg	TOPICAL	ANDA	27 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0727	OINTMENT	1 mg	TOPICAL	ANDA	24 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0727	OINTMENT	1 mg	TOPICAL	ANDA	24 sections
Sinuva	HUMAN PRESCRIPTION DRUG LABEL	1	10599-003	IMPLANT	1350 ug	INTRASINAL	NDA	29 sections
Sinuva	HUMAN PRESCRIPTION DRUG LABEL	1	10599-003	IMPLANT	1350 ug	INTRASINAL	NDA	29 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	13668-527	OINTMENT	1 mg	TOPICAL	ANDA	26 sections
MOMETASONE FUROATE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-993	CREAM	1 mg	TOPICAL	ANDA	10 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	16714-974	CREAM	1 mg	TOPICAL	ANDA	27 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	21695-786	CREAM	1 mg	TOPICAL	ANDA	13 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	42254-175	OINTMENT	1 mg	TOPICAL	ANDA	13 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	45802-118	SOLUTION	1 mg	TOPICAL	ANDA	27 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	45802-118	SOLUTION	1 mg	TOPICAL	ANDA	27 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	45802-119	OINTMENT	1 mg	TOPICAL	ANDA	29 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	45802-257	CREAM	1 mg	TOPICAL	ANDA	29 sections
Mometasone Furoate	HUMAN PRESCRIPTION DRUG LABEL	1	45802-257	CREAM	1 mg	TOPICAL	ANDA	29 sections