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

Stem definition	Drug id	CAS RN
corticosteroids, except prednisolone derivatives	1388	50-23-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: hydrocortisone 17-hydroxycorticosterone acticort cetacort hydracort hydrasson hydrocortisyl cortisol	The main glucocorticoid secreted by the ADRENAL CORTEX. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions. Molecular weight: 362.47 Formula: C21H30O5 CLOGP: 1.89 LIPINSKI: 0 HAC: 5 HDO: 3 TPSA: 94.83 ALOGS: -3.26 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

hydrocortisone
17-hydroxycorticosterone
acticort
cetacort
hydracort
hydrasson
hydrocortisyl
cortisol

The main glucocorticoid secreted by the ADRENAL CORTEX. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions.

Molecular weight: 362.47
Formula: C21H30O5
CLOGP: 1.89
LIPINSKI: 0
HAC: 5
HDO: 3
TPSA: 94.83
ALOGS: -3.26
ROTB: 2

Status: OFP

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

Drug dosage:

Dose	Unit	Route
30	mg	O
30	mg	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.23 mg/mL	Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	353.81 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	0.38 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	5.70 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.20 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.60 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
May 27, 2021	EMA	Diurnal Europe B.V.
Aug. 5, 1952	FDA	MERCK

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
Infusion related reaction	600.87	9.84	2010	212648	243511	63030853
Pericarditis	598.73	9.84	1353	213305	130226	63144138
Anti-cyclic citrullinated peptide antibody positive	568.20	9.84	1230	213428	114982	63159382
Rheumatoid factor positive	531.73	9.84	993	213665	83413	63190951
Wound	521.83	9.84	1468	213190	161795	63112569
Duodenal ulcer perforation	489.39	9.84	977	213681	86232	63188132
Discomfort	479.21	9.84	1447	213211	165927	63108437
Helicobacter infection	472.94	9.84	999	213659	91786	63182578
Completed suicide	456.30	9.84	7	214651	145666	63128698
Hand deformity	440.95	9.84	1362	213296	158095	63116269
Intentional product use issue	418.34	9.84	1160	213498	126732	63147632
Glossodynia	393.23	9.84	1414	213244	177462	63096902
Synovitis	371.17	9.84	1430	213228	185488	63088876
Rheumatic fever	364.46	9.84	578	214080	42533	63231831
Hepatic enzyme increased	353.16	9.84	1487	213171	200841	63073523
Systemic lupus erythematosus	348.91	9.84	1515	213143	207403	63066961
Toxicity to various agents	348.00	9.84	202	214456	247048	63027316
Pemphigus	342.46	9.84	1378	213280	182348	63092016
Adrenocortical insufficiency acute	306.57	9.84	138	214520	1560	63272804
Swollen joint count increased	285.11	9.84	469	214189	35585	63238779
Death	283.60	9.84	521	214137	373860	62900504
Blister	276.46	9.84	1016	213642	128798	63145566
Arthropathy	272.31	9.84	1535	213123	233257	63041107
Type 2 diabetes mellitus	266.28	9.84	635	214023	63233	63211131
Swelling	255.95	9.84	1700	212958	273678	63000686
Hypersensitivity	239.17	9.84	1751	212907	290934	62983430
Blood cholesterol increased	237.56	9.84	779	213879	93253	63181111
Product use issue	218.01	9.84	1383	213275	219137	63055227
Abdominal discomfort	217.19	9.84	1838	212820	319047	62955317
Fall	216.06	9.84	647	214011	391687	62882677
Drug abuse	194.13	9.84	13	214645	72505	63201859
Drug intolerance	191.68	9.84	1735	212923	306926	62967438
Folliculitis	188.88	9.84	595	214063	69722	63204642
Irritable bowel syndrome	185.53	9.84	657	214001	81755	63192609
Alopecia	182.24	9.84	1842	212816	335694	62938670
Condition aggravated	181.20	9.84	2117	212541	400100	62874264
Injury	178.00	9.84	599	214059	72648	63201716
Drug interaction	171.37	9.84	321	214337	228810	63045554
Maternal exposure during pregnancy	164.63	9.84	1290	213368	218772	63055592
Muscle injury	163.77	9.84	540	214118	64805	63209559
Intentional overdose	161.45	9.84	28	214630	74124	63200240
Steroid withdrawal syndrome	161.36	9.84	63	214595	482	63273882
Overdose	152.06	9.84	101	214557	114977	63159387
Adrenal insufficiency	151.08	9.84	240	214418	17675	63256689
Hip arthroplasty	149.53	9.84	426	214232	47220	63227144
Drug hypersensitivity	145.91	9.84	1649	213009	309038	62965326
Colitis ulcerative	138.71	9.84	286	214372	25805	63248559
Fibromyalgia	136.11	9.84	586	214072	79834	63194530
Sleep disorder due to general medical condition, insomnia type	134.87	9.84	436	214222	51781	63222583
Treatment failure	126	9.84	1124	213534	197919	63076445
Rash	125.47	9.84	2623	212035	558248	62716116
Product dose omission issue	118.55	9.84	401	214257	233912	63040452
Acute kidney injury	116.80	9.84	476	214182	262939	63011425
Liver injury	108.62	9.84	449	214209	60071	63214293
Contraindicated product administered	107.92	9.84	1168	213490	216480	63057884
Knee arthroplasty	105.95	9.84	413	214245	53793	63220571
Therapeutic product effect decreased	105.34	9.84	1057	213601	192130	63082234
Deep vein thrombosis postoperative	103.81	9.84	158	214500	11211	63263153
Impaired healing	98.62	9.84	639	214019	101903	63172461
Prescribed overdose	97.24	9.84	295	214363	33858	63240506
Joint swelling	96.92	9.84	1601	213057	326065	62948299
Suicide attempt	92.58	9.84	45	214613	60873	63213491
Inappropriate schedule of product administration	91.64	9.84	634	214024	103331	63171033
Craniopharyngioma	91.38	9.84	30	214628	128	63274236
Frequent bowel movements	89.60	9.84	223	214435	22799	63251565
Off label use	88.62	9.84	2941	211717	671521	62602843
Lip dry	87.48	9.84	174	214484	15296	63259068
Blood pressure fluctuation	85.77	9.84	347	214311	45970	63228394
Facet joint syndrome	84.19	9.84	149	214509	11989	63262375
Device expulsion	83.41	9.84	10	214648	34912	63239452
Autoimmune disorder	82.86	9.84	181	214477	16996	63257368
Febrile bone marrow aplasia	80.29	9.84	111	214547	7214	63267150
Anaemia	79.55	9.84	623	214035	292807	62981557
Sedation	77.49	9.84	18	214640	38791	63235573
General physical health deterioration	77.06	9.84	1029	213629	200373	63073991
Adverse event	76.99	9.84	440	214218	67119	63207245
Adjustment disorder with depressed mood	76.98	9.84	130	214528	10074	63264290
Live birth	76.39	9.84	225	214433	25405	63248959
Mobility decreased	73.94	9.84	679	213979	120480	63153884
Musculoskeletal stiffness	73.44	9.84	950	213708	183668	63090696
Hypofibrinogenaemia	73.28	9.84	47	214611	1123	63273241
Lower respiratory tract infection	73.08	9.84	726	213932	131581	63142783
Psoriatic arthropathy	72.49	9.84	544	214114	90976	63183388
Cognitive disorder	72.35	9.84	50	214608	55765	63218599
Lupus vulgaris	70.51	9.84	94	214564	5900	63268464
Cerebrovascular accident	69.22	9.84	165	214493	107859	63166505
Cardiac failure congestive	68.57	9.84	130	214528	92303	63182061
Atrial fibrillation	67.92	9.84	187	214471	116449	63157915
Drug tolerance decreased	67.73	9.84	169	214489	17304	63257060
Myocardial infarction	67.72	9.84	148	214510	99745	63174619
Renal impairment	67.55	9.84	122	214536	88233	63186131
X-ray abnormal	67.49	9.84	108	214550	8002	63266362
Secondary adrenocortical insufficiency	67.08	9.84	48	214610	1380	63272984
Malignant neoplasm progression	66.80	9.84	109	214549	82012	63192352
Nausea	66.57	9.84	2295	212363	852176	62422188
Haemoglobin decreased	66.25	9.84	260	214398	145225	63129139
Drug level below therapeutic	66.18	9.84	82	214576	4784	63269580
Female genital tract fistula	66.13	9.84	103	214555	7456	63266908
Syncope	65.56	9.84	192	214466	117193	63157171
Pituitary tumour benign	65.08	9.84	54	214604	1941	63272423
Interstitial lung disease	64.91	9.84	68	214590	61840	63212524
Platelet count decreased	64.81	9.84	190	214468	115932	63158432
Anti-cyclic citrullinated peptide antibody	64.66	9.84	96	214562	6662	63267702
Neutropenia	64.58	9.84	338	214320	174667	63099697
Peripheral venous disease	64.58	9.84	154	214504	15323	63259041
Coma	63.84	9.84	74	214584	64290	63210074
Wheezing	63.08	9.84	545	214113	95050	63179314
Ill-defined disorder	61.97	9.84	481	214177	81274	63193090
Dislocation of vertebra	61.18	9.84	107	214551	8528	63265836
Full blood count abnormal	60.82	9.84	16	214642	31701	63242663
Balance disorder	60.65	9.84	121	214537	84301	63190063
White blood cell count decreased	59.33	9.84	255	214403	138849	63135515
Injection site pain	57.18	9.84	235	214423	129565	63144799
Wrong technique in product usage process	56.28	9.84	77	214581	62263	63212101
Serotonin syndrome	55.90	9.84	14	214644	28668	63245696
Gastrointestinal haemorrhage	55.24	9.84	120	214538	81056	63193308
Cardio-respiratory arrest	55.20	9.84	73	214585	59886	63214478
Disease progression	54.86	9.84	221	214437	122537	63151827
Injection site erythema	54.11	9.84	126	214532	83048	63191316
Depressed level of consciousness	53.74	9.84	79	214579	61999	63212365
Intentional self-injury	53.13	9.84	11	214647	25676	63248688
Cardiac failure	52.58	9.84	142	214516	89000	63185364
Stomatitis	51.47	9.84	705	213953	138020	63136344
Somnolence	50.91	9.84	374	214284	178311	63096053
Breast cancer	50.88	9.84	53	214605	48330	63226034
Electrocardiogram QT prolonged	50.32	9.84	77	214581	59453	63214911
Blood creatinine increased	49.54	9.84	143	214515	87701	63186663
Chronic obstructive pulmonary disease	49.32	9.84	85	214573	62601	63211763
Suicidal ideation	48.78	9.84	85	214573	62336	63212028
Rheumatoid arthritis	48.41	9.84	587	214071	253232	63021132
Adverse drug reaction	48.24	9.84	446	214212	79268	63195096
Pneumonia	47.68	9.84	1178	213480	455589	62818775
Breast cancer stage III	47.35	9.84	107	214551	10279	63264085
Tremor	47.33	9.84	258	214400	131981	63142383
Respiratory arrest	46.80	9.84	26	214632	32619	63241745
Joint range of motion decreased	44.29	9.84	222	214436	32206	63242158
Hyperadrenocorticism	43.31	9.84	22	214636	331	63274033
Intentional product misuse	43.16	9.84	88	214570	60829	63213535
Urticaria	43.11	9.84	794	213864	165008	63109356
Bradycardia	42.92	9.84	117	214541	73110	63201254
Hypercholesterolaemia	42.86	9.84	164	214494	21170	63253194
Product use in unapproved indication	42.60	9.84	846	213812	178234	63096130
Weight increased	42.60	9.84	1169	213489	259623	63014741
Cardiac arrest	41.09	9.84	167	214491	92378	63181986
Loss of consciousness	40.88	9.84	233	214425	117888	63156476
Injection site swelling	40.72	9.84	61	214597	47511	63226853
Pulmonary fibrosis	40.67	9.84	252	214406	39557	63234807
Hypotension	40.10	9.84	664	213994	271940	63002424
Cardiac disorder	39.89	9.84	69	214589	50747	63223617
Grip strength decreased	39.69	9.84	165	214493	22122	63252242
Hypertension	39.60	9.84	1230	213428	278073	62996291
Poor venous access	39.57	9.84	125	214533	14660	63259704
Hospitalisation	39.39	9.84	151	214507	84930	63189434
Wound infection	39.31	9.84	160	214498	21250	63253114
Contusion	39.16	9.84	719	213939	149325	63125039
Thrombocytopenia	39.03	9.84	325	214333	150832	63123532
Prescribed underdose	38.97	9.84	201	214457	29488	63244876
Adrenal suppression	38.74	9.84	29	214629	895	63273469
Blood creatine phosphokinase increased	38.46	9.84	28	214630	30402	63243962
Dehydration	37.33	9.84	390	214268	172964	63101400
Faecal calprotectin increased	37.32	9.84	50	214608	3153	63271211
Femur fracture	37.26	9.84	52	214606	41704	63232660
Cortisol decreased	37.14	9.84	32	214626	1212	63273152
Lactic acidosis	36.92	9.84	45	214613	38242	63236122
Lower limb fracture	36.81	9.84	171	214487	24050	63250314
Gastrointestinal disorder	36.77	9.84	636	214022	130603	63143761
Anal fissure	36.74	9.84	59	214599	4384	63269980
Feeling abnormal	36.55	9.84	323	214335	148069	63126295
Orthostatic hypotension	36.48	9.84	41	214617	36119	63238245
Accidental exposure to product	36.25	9.84	24	214634	27381	63246983
Vaginal flatulence	36.24	9.84	50	214608	3243	63271121
Therapy cessation	35.99	9.84	30	214628	30427	63243937
Leukopenia	35.89	9.84	137	214521	77153	63197211
Vaginal discharge	35.69	9.84	89	214569	9109	63265255
Musculoskeletal injury	35.43	9.84	14	214644	111	63274253
Multiple sclerosis relapse	35.23	9.84	69	214589	48409	63225955
Arthralgia	35.18	9.84	2304	212354	567406	62706958
Renal failure	35.08	9.84	243	214415	117409	63156955
Bronchitis	34.85	9.84	263	214395	124672	63149692
Human bocavirus infection	34.63	9.84	20	214638	393	63273971
Blepharospasm	34.57	9.84	68	214590	5928	63268436
Melaena	34.56	9.84	31	214627	30334	63244030
Maternal exposure timing unspecified	34.55	9.84	75	214583	7012	63267352
Hepatic function abnormal	34.41	9.84	45	214613	37097	63237267
Drug withdrawal syndrome	34.40	9.84	25	214633	27169	63247195
Metastases to bone	34.33	9.84	14	214644	21005	63253359
Red blood cell sedimentation rate abnormal	34.27	9.84	12	214646	19770	63254594
Therapeutic response shortened	34.13	9.84	103	214555	11785	63262579
C-reactive protein	33.95	9.84	60	214598	4822	63269542
Injection site reaction	33.93	9.84	94	214564	58430	63215934
Pleural effusion	33.82	9.84	181	214477	93029	63181335
Hypothalamic pituitary adrenal axis suppression	33.68	9.84	15	214643	165	63274199
Proctitis	32.95	9.84	63	214595	5378	63268986
Herpes zoster	32.84	9.84	155	214503	82307	63192057
Seizure	32.53	9.84	289	214369	132345	63142019
Hyperhidrosis	32.51	9.84	222	214436	107614	63166750
Rhabdomyolysis	32.42	9.84	62	214596	43889	63230475
Hypothalamo-pituitary disorder	32.39	9.84	24	214634	729	63273635
Alanine aminotransferase increased	32.10	9.84	212	214446	103558	63170806
Migraine	31.95	9.84	509	214149	102837	63171527
Osteonecrosis of jaw	31.08	9.84	44	214614	35079	63239285
Unevaluable event	30.95	9.84	81	214577	51305	63223059
Acute myocardial infarction	30.72	9.84	38	214620	32086	63242278
Therapy interrupted	30.40	9.84	39	214619	32416	63241948
Creatinine renal clearance decreased	29.83	9.84	9	214649	16299	63258065
Hepatotoxicity	29.34	9.84	50	214608	36991	63237373
Eczema	29.06	9.84	198	214460	32093	63242271
Liver function test abnormal	28.98	9.84	76	214582	48105	63226259
Fistula	28.86	9.84	89	214569	10304	63264060
Perfume sensitivity	28.81	9.84	23	214635	782	63273582
Body temperature fluctuation	28.68	9.84	37	214621	2248	63272116
Insulin-like growth factor increased	28.17	9.84	24	214634	895	63273469
Aspartate aminotransferase increased	28.14	9.84	184	214474	90093	63184271
Drug level decreased	28.01	9.84	74	214584	7845	63266519
Night sweats	27.97	9.84	270	214388	48544	63225820
Abortion spontaneous	27.96	9.84	75	214583	47120	63227244
Asthenia	27.71	9.84	1039	213619	382565	62891799
Nasopharyngitis	27.60	9.84	1086	213572	253171	63021193
Neuroleptic malignant syndrome	27.48	9.84	4	214654	12052	63262312
Skin ulcer	27.36	9.84	66	214592	42979	63231385
Hypopituitarism	27.33	9.84	26	214632	1122	63273242
Haematochezia	27.24	9.84	289	214369	53255	63221109
Myelosuppression	27.21	9.84	24	214634	23679	63250685
Pruritus	27.00	9.84	1487	213171	359966	62914398
Fluid retention	26.94	9.84	107	214551	59579	63214785
Oedema peripheral	26.74	9.84	465	214193	189046	63085318
Obesity	26.57	9.84	183	214475	29769	63244595
Dry eye	26.30	9.84	62	214596	40699	63233665
Plasma cell myeloma	26.18	9.84	51	214607	35854	63238510
Steroid dependence	26.06	9.84	31	214627	1733	63272631
Urticaria thermal	25.94	9.84	17	214641	422	63273942
Oedema	25.88	9.84	469	214189	97153	63177211
International normalised ratio increased	25.86	9.84	76	214582	46349	63228015
Agitation	25.79	9.84	109	214549	59648	63214716
Rhinovirus infection	25.68	9.84	51	214607	4478	63269886
Mucous stools	25.50	9.84	49	214609	4199	63270165
Arrhythmia	25.43	9.84	57	214601	38083	63236281
Insulin-like growth factor decreased	25.03	9.84	16	214642	380	63273984
Device dislocation	25.01	9.84	30	214628	25675	63248689
Salpingo-oophorectomy unilateral	24.97	9.84	22	214636	859	63273505
Chronic kidney disease	24.79	9.84	75	214583	45323	63229041
Drug level above therapeutic	24.75	9.84	52	214606	4753	63269611
Neoplasm recurrence	24.56	9.84	37	214621	2601	63271763
Blood glucose increased	24.47	9.84	174	214484	83582	63190782
Normal tension glaucoma	24.39	9.84	8	214650	34	63274330
Gait inability	24.27	9.84	280	214378	52679	63221685
Herpes simplex oesophagitis	24.08	9.84	12	214646	173	63274191
Dizziness	24.07	9.84	1198	213460	428727	62845637
Natural killer-cell leukaemia	23.92	9.84	10	214648	93	63274271
Ascites	23.92	9.84	65	214593	40663	63233701
Thrombosis	23.90	9.84	125	214533	64630	63209734
Renal disorder	23.90	9.84	47	214611	32927	63241437
Sciatica	23.85	9.84	198	214460	34126	63240238
Dyskinesia	23.73	9.84	45	214613	31957	63242407
Complication associated with device	23.65	9.84	14	214644	16964	63257400
Heart rate irregular	23.57	9.84	143	214515	22278	63252086
Pulmonary hypertension	23.53	9.84	57	214601	37066	63237298
Sleep disorder	23.46	9.84	397	214261	81169	63193195
Pulmonary arterial hypertension	23.43	9.84	25	214633	22552	63251812
Hypophysitis	23.41	9.84	30	214628	1811	63272553
Drug eruption	23.41	9.84	38	214620	28656	63245708
Diabetes insipidus	23.29	9.84	36	214622	2589	63271775
Transient ischaemic attack	23.12	9.84	59	214599	37694	63236670
Blood parathyroid hormone decreased	22.90	9.84	3	214655	9788	63264576
Rheumatoid nodule	22.72	9.84	15	214643	17140	63257224
Hypercalcaemia	22.64	9.84	38	214620	28284	63246080
Anal fistula	22.60	9.84	42	214616	3509	63270855
Perioral dermatitis	22.58	9.84	13	214645	254	63274110
Exposure during pregnancy	22.54	9.84	687	213971	154860	63119504
Musculoskeletal disorder	22.40	9.84	22	214636	20622	63253742
Radiculopathy	22.31	9.84	72	214586	8539	63265825
Dysarthria	22.31	9.84	72	214586	42639	63231725
Dermatitis atopic	22.27	9.84	78	214580	9646	63264718
Antithrombin III	22.23	9.84	11	214647	156	63274208
Breast cancer female	22.19	9.84	9	214649	13550	63260814
Walking aid user	22.03	9.84	83	214575	10634	63263730
Tendon pain	22.00	9.84	40	214618	3286	63271078
Basal cell carcinoma	21.97	9.84	38	214620	27953	63246411
Hallucination	21.85	9.84	103	214555	54714	63219650
Constipation	21.84	9.84	586	214072	224357	63050007
Vision blurred	21.79	9.84	202	214456	91722	63182642
Bursitis	21.77	9.84	206	214452	36835	63237529
Device difficult to use	21.76	9.84	8	214650	12788	63261576
Faecal volume decreased	21.62	9.84	11	214647	166	63274198
Blood calcium decreased	21.60	9.84	35	214623	26416	63247948
Colitis	21.53	9.84	255	214403	48273	63226091
Neoplasm progression	21.50	9.84	58	214600	36370	63237994
Product prescribing error	21.27	9.84	35	214623	26254	63248110
Product quality issue	21.24	9.84	57	214601	35808	63238556
Schizophrenia	21.13	9.84	4	214654	9948	63264416
Cataract	21.13	9.84	110	214548	56943	63217421
Coronary artery disease	21.09	9.84	49	214609	32328	63242036
Poisoning deliberate	20.87	9.84	6	214652	11212	63263152
Abdominal pain upper	20.83	9.84	875	213783	205569	63068795
Metastases to liver	20.53	9.84	30	214628	23609	63250755
Proctalgia	20.51	9.84	56	214602	6054	63268310
Haematuria	19.91	9.84	43	214615	29114	63245250
Aphasia	19.88	9.84	52	214606	32948	63241416
Epistaxis	19.85	9.84	154	214504	72571	63201793
Excessive eye blinking	19.75	9.84	23	214635	1257	63273107
Vertigo	19.72	9.84	120	214538	59767	63214597
Respiratory failure	19.60	9.84	235	214423	101623	63172741
Metabolic acidosis	19.58	9.84	82	214576	44987	63229377
Panniculitis	19.56	9.84	7	214651	11378	63262986
Respiratory depression	19.55	9.84	11	214647	13704	63260660
Pancytopenia	19.29	9.84	222	214436	96711	63177653
Palmar-plantar erythrodysaesthesia syndrome	19.23	9.84	30	214628	22985	63251379
Adrenal disorder	19.03	9.84	26	214632	1671	63272693
Lung neoplasm malignant	19.01	9.84	23	214635	19610	63254754
Hypoaesthesia	18.90	9.84	722	213936	167671	63106693
Toxic skin eruption	18.85	9.84	10	214648	12875	63261489
Airway peak pressure increased	18.85	9.84	12	214646	283	63274081
Granuloma skin	18.77	9.84	3	214655	8434	63265930
Road traffic accident	18.76	9.84	198	214460	36434	63237930
Diaphragm muscle weakness	18.58	9.84	6	214652	24	63274340
Therapeutic product effect incomplete	18.56	9.84	304	214354	124752	63149612
Strongyloidiasis	18.55	9.84	22	214636	1226	63273138
Secondary immunodeficiency	18.32	9.84	23	214635	1360	63273004
Hypomagnesaemia	18.31	9.84	44	214614	28693	63245671
Myoclonus	18.30	9.84	16	214642	15852	63258512
Pneumonia aspiration	18.20	9.84	58	214600	34482	63239882
Asphyxia	18.16	9.84	54	214604	6127	63268237
Hypertensive crisis	18.13	9.84	15	214643	15271	63259093
Drug resistance	18.12	9.84	31	214627	22902	63251462
Meningitis candida	18.11	9.84	7	214651	52	63274312
Gastroenteritis norovirus	17.84	9.84	28	214630	2040	63272324
Myalgia	17.75	9.84	369	214289	146160	63128204
Injection site bruising	17.75	9.84	77	214581	41833	63232531
Joint effusion	17.59	9.84	19	214639	17041	63257323
Neutrophil count decreased	17.55	9.84	115	214543	56291	63218073
Diarrhoea	17.52	9.84	2135	212523	713231	62561133
Sinusitis fungal	17.50	9.84	26	214632	1805	63272559
Product storage error	17.34	9.84	15	214643	14941	63259423
Osteopenia	17.29	9.84	25	214633	19760	63254604
Injection site pruritus	17.27	9.84	86	214572	45030	63229334
Skin fragility	17.22	9.84	16	214642	670	63273694
Back pain	17.19	9.84	724	213934	263421	63010943
Dystonia	17.09	9.84	13	214645	13806	63260558
Tenosynovitis	17.04	9.84	13	214645	13782	63260582
Parkinsonism	16.97	9.84	7	214651	10432	63263932
Blood alkaline phosphatase increased	16.97	9.84	81	214577	42886	63231478
Myelodysplastic syndrome	16.89	9.84	19	214639	16735	63257629
Anticipatory anxiety	16.88	9.84	21	214637	1230	63273134
Pseudohypoaldosteronism	16.84	9.84	5	214653	14	63274350
Hypophagia	16.81	9.84	52	214606	31207	63243157
Dysphagia	16.81	9.84	205	214453	88380	63185984
Palpitations	16.78	9.84	274	214384	112496	63161868
Hypogonadism	16.72	9.84	8	214650	105	63274259
Bone disorder	16.70	9.84	29	214629	21297	63253067
Clostridium difficile colitis	16.69	9.84	123	214535	20446	63253918
Gastrointestinal toxicity	16.68	9.84	3	214655	7738	63266626
Allergy test positive	16.62	9.84	15	214643	605	63273759
Urinary retention	16.59	9.84	50	214608	30251	63244113
Eczema herpeticum	16.38	9.84	9	214649	160	63274204
No adverse event	16.38	9.84	78	214580	41327	63233037
Dyspepsia	16.34	9.84	457	214201	101739	63172625
Natural killer cell count decreased	16.33	9.84	6	214652	38	63274326
Hepatitis	16.31	9.84	74	214584	39714	63234650
Upper gastrointestinal haemorrhage	16.30	9.84	24	214634	18828	63255536
Hyponatraemia	16.28	9.84	273	214385	111627	63162737
Loss of employment	16.15	9.84	28	214630	2216	63272148
Hypoxia	16.13	9.84	127	214531	59665	63214699
B-lymphocyte count increased	16.13	9.84	8	214650	114	63274250
Hyperkalaemia	16.12	9.84	112	214546	54091	63220273
Anal abscess	16.09	9.84	43	214615	4589	63269775
Ulcer	15.83	9.84	41	214617	26066	63248298
Macular degeneration	15.79	9.84	37	214621	24339	63250025
Metastases to lung	15.77	9.84	12	214646	12738	63261626
Full blood count decreased	15.68	9.84	41	214617	25983	63248381
Taste disorder	15.57	9.84	89	214569	13573	63260791
Bone marrow failure	15.56	9.84	49	214609	29241	63245123
Haematoma	15.34	9.84	63	214595	34757	63239607
Muscle rigidity	15.30	9.84	10	214648	11490	63262874
Red blood cell count decreased	15.26	9.84	78	214580	40567	63233797
Hyperemesis gravidarum	15.23	9.84	14	214644	578	63273786
Tendonitis	15.18	9.84	116	214542	19499	63254865
Blood potassium increased	15.17	9.84	24	214634	18285	63256079
Akathisia	15.09	9.84	6	214652	9140	63265224
Pituitary tumour recurrent	15.04	9.84	7	214651	86	63274278
Mitral valve incompetence	15.02	9.84	27	214631	19567	63254797
Tardive dyskinesia	15.00	9.84	5	214653	8497	63265867
Rectal haemorrhage	14.96	9.84	241	214417	48789	63225575
Cerebral microangiopathy	14.95	9.84	10	214648	257	63274107
Ventricular tachycardia	14.90	9.84	28	214630	19951	63254413
Depression	14.88	9.84	529	214129	195963	63078401
Catarrh	14.81	9.84	22	214636	1527	63272837
Myocardial ischaemia	14.78	9.84	13	214645	12846	63261518
Excessive skin	14.78	9.84	8	214650	138	63274226
Defaecation urgency	14.75	9.84	39	214619	4136	63270228
Sedation complication	14.69	9.84	15	214643	13807	63260557
Neoplasm malignant	14.47	9.84	52	214606	29809	63244555
Cough	14.43	9.84	826	213832	291917	62982447
Psychotic disorder	14.38	9.84	42	214616	25670	63248694
Sputum increased	14.31	9.84	28	214630	2431	63271933
Abnormal behaviour	14.30	9.84	32	214626	21394	63252970
Altered state of consciousness	14.27	9.84	41	214617	25189	63249175
Drug specific antibody present	14.26	9.84	39	214619	4220	63270144
Secondary hypogonadism	14.23	9.84	7	214651	98	63274266
Breast cancer stage I	14.14	9.84	3	214655	6886	63267478
Haematotoxicity	14.13	9.84	7	214651	9369	63264995
Proteinuria	14.13	9.84	27	214631	19118	63255246
Tuberculosis gastrointestinal	14.09	9.84	11	214647	362	63274002
CSF lymphocyte count abnormal	14.08	9.84	3	214655	0	63274364
Infection	13.92	9.84	926	213732	228247	63046117
Pain in jaw	13.88	9.84	88	214570	43408	63230956
C-reactive protein abnormal	13.85	9.84	226	214432	45870	63228494
Pulmonary embolism	13.79	9.84	295	214363	116389	63157975
Erythema nodosum	13.77	9.84	42	214616	4833	63269531
Labelled drug-drug interaction medication error	13.73	9.84	15	214643	13384	63260980
Pulmonary oedema	13.69	9.84	119	214539	54754	63219610
Extrapyramidal disorder	13.47	9.84	15	214643	13269	63261095
Mastocytosis	13.44	9.84	13	214645	573	63273791
Blood potassium decreased	13.42	9.84	85	214573	41941	63232423
Cerebral infarction	13.39	9.84	39	214619	23854	63250510
Enterococcal sepsis	13.36	9.84	20	214638	1398	63272966
Device malfunction	13.34	9.84	25	214633	17832	63256532
Cellulitis	13.25	9.84	196	214462	81762	63192602
Head injury	13.08	9.84	48	214610	27348	63247016
Tongue disorder	13.03	9.84	10	214648	10570	63263794
Oral candidiasis	13.01	9.84	126	214532	22672	63251692
Hypoaldosteronism	12.94	9.84	8	214650	179	63274185
Skin injury	12.83	9.84	22	214636	1726	63272638
Embolism venous	12.75	9.84	31	214627	3123	63271241
Abdominal pain	12.75	9.84	1155	213503	292301	62982063
Blood urea increased	12.74	9.84	46	214612	26333	63248031
Cerebral haemorrhage	12.68	9.84	57	214601	30672	63243692
Synovial cyst	12.67	9.84	10	214648	10423	63263941
Diabetic ketoacidosis	12.59	9.84	32	214626	20473	63253891
Hip fracture	12.57	9.84	54	214604	29420	63244944
Torsade de pointes	12.55	9.84	16	214642	13335	63261029
Gastrointestinal scarring	12.43	9.84	10	214648	344	63274020
Drug tolerance	12.41	9.84	4	214654	6945	63267419
Carpal tunnel syndrome	12.39	9.84	33	214625	20784	63253580
Atrial septal defect	12.38	9.84	4	214654	6934	63267430
Transplant rejection	12.27	9.84	11	214647	10769	63263595
Rash pruritic	12.27	9.84	136	214522	59663	63214701
Dysgeusia	12.24	9.84	100	214558	46610	63227754
Jaundice	12.23	9.84	54	214604	29197	63245167
Aspergillus infection	12.20	9.84	57	214601	8036	63266328
Insomnia	12.17	9.84	599	214059	214653	63059711
Aborted pregnancy	12.10	9.84	5	214653	45	63274319
Seronegative arthritis	12.03	9.84	35	214623	3924	63270440
Pus in stool	12.01	9.84	5	214653	46	63274318
Aggression	12.00	9.84	40	214618	23458	63250906
Disorientation	11.99	9.84	81	214577	39371	63234993
Vaginal haemorrhage	11.95	9.84	50	214608	27437	63246927
Restlessness	11.94	9.84	55	214603	29398	63244966
Acute generalised exanthematous pustulosis	11.85	9.84	12	214646	11087	63263277
Brachycephaly	11.84	9.84	4	214654	19	63274345
Ischaemic stroke	11.84	9.84	27	214631	17930	63256434
Faecal calprotectin abnormal	11.83	9.84	6	214652	90	63274274
White blood cell count increased	11.81	9.84	106	214552	48455	63225909
Diffuse large B-cell lymphoma	11.75	9.84	4	214654	6708	63267656
Breast cancer metastatic	11.72	9.84	14	214644	12004	63262360
Delusion	11.72	9.84	14	214644	12003	63262361
Tessellated fundus	11.64	9.84	5	214653	50	63274314
Blood pressure systolic abnormal	11.61	9.84	17	214641	13369	63260995
Mydriasis	11.58	9.84	14	214644	11942	63262422
Pulmonary toxicity	11.56	9.84	9	214649	9446	63264918
Neutrophilic panniculitis	11.56	9.84	5	214653	51	63274313
Osteomyelitis	11.51	9.84	47	214611	25973	63248391
Shared psychotic disorder	11.51	9.84	4	214654	21	63274343
Hypoperfusion	11.48	9.84	19	214639	1448	63272916
Increased bronchial secretion	11.38	9.84	21	214637	1745	63272619
Duodenal ulcer	11.38	9.84	6	214652	7750	63266614
Electrocardiogram QRS complex prolonged	11.37	9.84	3	214655	5935	63268429
Anorectal ulcer	11.31	9.84	5	214653	54	63274310
Norovirus test positive	11.30	9.84	8	214650	226	63274138
Mental status changes	11.21	9.84	83	214575	39516	63234848
Arteriosclerosis coronary artery	11.20	9.84	57	214601	8316	63266048
Blood pressure diastolic abnormal	11.18	9.84	20	214638	14522	63259842
Pneumatosis intestinalis	11.16	9.84	25	214633	2388	63271976
Chromaturia	11.13	9.84	25	214633	16692	63257672
PO2 decreased	11.11	9.84	19	214639	1487	63272877
Neutropenic infection	11.10	9.84	18	214640	1349	63273015
Non-consummation	11.07	9.84	5	214653	57	63274307
Pancreatic carcinoma	11.04	9.84	6	214652	7622	63266742
Pyoderma gangrenosum	10.97	9.84	32	214626	3593	63270771
Hypervolaemia	10.96	9.84	54	214604	28359	63246005
Tendon rupture	10.96	9.84	56	214602	8183	63266181
Adrenocorticotropic hormone deficiency	10.96	9.84	10	214648	409	63273955
Eye injury	10.94	9.84	28	214630	2911	63271453
Electrocardiogram abnormal	10.90	9.84	9	214649	9170	63265194
Skin necrosis	10.89	9.84	19	214639	13931	63260433
Burns second degree	10.89	9.84	22	214636	1956	63272408
Ankle fracture	10.86	9.84	28	214630	17827	63256537
Confusional state	10.82	9.84	934	213724	235446	63038918
Febrile neutropenia	10.82	9.84	497	214161	117952	63156412
Enthesopathy	10.79	9.84	8	214650	8606	63265758
Injection site mass	10.78	9.84	30	214628	18626	63255738
Invasive ductal breast carcinoma	10.78	9.84	5	214653	6953	63267411
Gamma-glutamyltransferase increased	10.78	9.84	69	214589	33962	63240402
Glomerular filtration rate decreased	10.78	9.84	18	214640	13423	63260941
Subdural haematoma	10.75	9.84	20	214638	14308	63260056
Skin weeping	10.74	9.84	13	214645	740	63273624
Blood pressure abnormal	10.72	9.84	22	214636	15176	63259188
Mood altered	10.70	9.84	21	214637	14722	63259642
Immunodeficiency	10.68	9.84	34	214624	20220	63254144
Pneumatosis	10.64	9.84	10	214648	425	63273939
Pain	10.64	9.84	2737	211921	737891	62536473
Leukoencephalopathy	10.63	9.84	36	214622	4377	63269987
Hepatic rupture	10.63	9.84	5	214653	63	63274301
Platelet count increased	10.60	9.84	28	214630	17683	63256681
Enterovirus infection	10.57	9.84	15	214643	999	63273365
Blood corticotrophin decreased	10.56	9.84	9	214649	336	63274028
Foetal death	10.48	9.84	13	214645	10967	63263397
Laboratory test abnormal	10.47	9.84	51	214607	26861	63247503
White blood cell count abnormal	10.45	9.84	4	214654	6238	63268126
Bone density decreased	10.44	9.84	21	214637	14591	63259773
Intermenstrual bleeding	10.40	9.84	7	214651	7919	63266445
Therapy non-responder	10.39	9.84	333	214325	75568	63198796
Accidental overdose	10.38	9.84	42	214616	23267	63251097
Status asthmaticus	10.36	9.84	14	214644	890	63273474
Retinitis	10.36	9.84	45	214613	6151	63268213
Therapeutic reaction time decreased	10.34	9.84	24	214634	2346	63272018
Miosis	10.33	9.84	6	214652	7347	63267017
Respiratory tract infection	10.33	9.84	90	214568	41393	63232971
Injection site rash	10.32	9.84	31	214627	18778	63255586
Surgery	10.29	9.84	75	214583	35837	63238527
Lymphocyte count decreased	10.29	9.84	60	214598	30197	63244167
Jaundice cholestatic	10.26	9.84	6	214652	7318	63267046
Vaginal abscess	10.26	9.84	10	214648	445	63273919
Optic glioma	10.21	9.84	3	214655	8	63274356
Product administration error	10.20	9.84	40	214618	22357	63252007
Dyspnoea exertional	10.17	9.84	143	214515	60159	63214205
Glucocorticoid deficiency	10.12	9.84	8	214650	268	63274096
Heart rate decreased	10.08	9.84	213	214445	45347	63229017
Aplastic anaemia	10.04	9.84	61	214597	9508	63264856
Astrocytoma	10.04	9.84	5	214653	72	63274292
Spondylitis	10.04	9.84	35	214623	4319	63270045
Blood growth hormone increased	9.98	9.84	10	214648	460	63273904
Eating disorder	9.97	9.84	32	214626	18984	63255380
Cerebral vasoconstriction	9.93	9.84	16	214642	1192	63273172
Nodule	9.93	9.84	37	214621	20989	63253375
Geotrichum infection	9.91	9.84	10	214648	464	63273900
Abortion induced	9.91	9.84	12	214646	10230	63264134
Pituitary infarction	9.88	9.84	4	214654	34	63274330
Visual pathway disorder	9.88	9.84	4	214654	34	63274330
Muscle spasticity	9.88	9.84	39	214619	21755	63252609

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
Intentional product use issue	276.87	10.17	537	92258	59279	34804857
Blood pressure fluctuation	247.61	10.17	320	92475	24929	34839207
Adrenal insufficiency	233.27	10.17	234	92561	13813	34850323
Drug abuse	224.03	10.17	9	92786	99087	34765049
Completed suicide	203.09	10.17	15	92780	98153	34765983
Toxicity to various agents	196.64	10.17	147	92648	200215	34663921
Off label use	191.35	10.17	1822	90973	417702	34446434
Death	187.24	10.17	496	92299	397553	34466583
Inappropriate schedule of product administration	177.47	10.17	461	92334	61835	34802301
Craniopharyngioma	166.29	10.17	52	92743	247	34863889
Adrenocortical insufficiency acute	153.29	10.17	78	92717	1522	34862614
Infusion related reaction	152.50	10.17	394	92401	52663	34811473
Graft loss	133.68	10.17	59	92736	824	34863312
Condition aggravated	131.15	10.17	916	91879	191280	34672856
Frequent bowel movements	126.79	10.17	163	92632	12624	34851512
Colitis ulcerative	126.71	10.17	186	92609	16334	34847802
Febrile bone marrow aplasia	115.20	10.17	125	92670	8084	34856052
Serum sickness	108.19	10.17	67	92728	1933	34862203
Adrenal suppression	106.97	10.17	46	92749	601	34863535
Heart rate decreased	99.82	10.17	244	92551	31501	34832635
Hypofibrinogenaemia	89.99	10.17	56	92739	1630	34862506
Febrile neutropenia	83.86	10.17	636	92159	136213	34727923
Bronchiectasis	83.46	10.17	116	92679	9685	34854451
Aplastic anaemia	82.75	10.17	115	92680	9601	34854535
Heart rate irregular	81.84	10.17	149	92646	15658	34848478
Faecal calprotectin increased	80.02	10.17	61	92734	2483	34861653
Hypopituitarism	79.10	10.17	58	92737	2224	34861912
Impaired quality of life	77.14	10.17	86	92709	5732	34858404
Intentional overdose	74.55	10.17	13	92782	43661	34820475
Drug level below therapeutic	74.45	10.17	83	92712	5532	34858604
Diabetes insipidus	66.36	10.17	58	92737	2870	34861266
Drug interaction	66.02	10.17	342	92453	225604	34638532
Leukoencephalopathy	65.92	10.17	68	92727	4147	34859989
Interstitial lung disease	65.05	10.17	47	92748	65235	34798901
Product use issue	64.55	10.17	335	92460	62881	34801255
Drug specific antibody present	64.46	10.17	60	92735	3225	34860911
Overdose	60.97	10.17	92	92703	90967	34773169
Body temperature fluctuation	59.21	10.17	43	92752	1624	34862512
Steroid withdrawal syndrome	56.03	10.17	22	92773	224	34863912
Steroid dependence	55.87	10.17	40	92755	1477	34862659
Cortisol decreased	54.08	10.17	35	92760	1092	34863044
Mucosal inflammation	52.89	10.17	223	92572	38399	34825737
Arthralgia	51.56	10.17	683	92112	169358	34694778
Pituitary tumour benign	48.89	10.17	30	92765	851	34863285
Fall	48.65	10.17	327	92468	202558	34661578
Tendon pain	48.07	10.17	49	92746	2946	34861190
Myocardial infarction	47.20	10.17	164	92631	120921	34743215
Blood pressure increased	47.09	10.17	397	92398	87705	34776431
Insulin-like growth factor decreased	47.08	10.17	20	92775	253	34863883
Anal inflammation	44.97	10.17	33	92762	1267	34862869
Soft tissue mass	44.89	10.17	30	92765	989	34863147
Tendon disorder	44.27	10.17	46	92749	2829	34861307
Eczema	44.04	10.17	128	92667	18308	34845828
Acute kidney injury	43.90	10.17	559	92236	304429	34559707
Gingival disorder	43.17	10.17	34	92761	1453	34862683
Septic shock	42.89	10.17	332	92463	71502	34792634
Pseudostroke	42.67	10.17	12	92783	36	34864100
Fistula	42.63	10.17	70	92725	6770	34857366
Multimorbidity	42.14	10.17	28	92767	914	34863222
Cardiac failure	40.90	10.17	116	92679	91132	34773004
Suicide attempt	40.50	10.17	27	92768	39089	34825047
Oesophageal perforation	40.49	10.17	30	92765	1169	34862967
Therapeutic response shortened	39.86	10.17	71	92724	7333	34856803
Sedation	38.72	10.17	5	92790	21001	34843135
Anaemia	38.03	10.17	416	92379	232919	34631217
Atrial fibrillation	37.54	10.17	182	92613	122211	34741925
Insulin-like growth factor increased	37.33	10.17	29	92766	1214	34862922
Anal fissure	36.86	10.17	51	92744	4239	34859897
Weight increased	36.19	10.17	392	92403	92641	34771495
Tendon rupture	36.17	10.17	66	92729	6946	34857190
Hypophysitis	35.96	10.17	37	92758	2249	34861887
Poor venous access	34.98	10.17	55	92740	5128	34859008
Drug level decreased	34.49	10.17	69	92726	7777	34856359
Hypertriglyceridaemia	34.42	10.17	72	92723	8376	34855760
Flushing	33.90	10.17	173	92622	32247	34831889
Colitis	33.10	10.17	192	92603	37558	34826578
Superinfection	32.99	10.17	37	92758	2482	34861654
Neoplasm recurrence	32.88	10.17	35	92760	2214	34861922
Hypogonadism	32.80	10.17	35	92760	2220	34861916
Anal fistula	31.97	10.17	54	92741	5345	34858791
Erythema	31.32	10.17	367	92428	88413	34775723
Growth retardation	31.06	10.17	31	92764	1817	34862319
Pelvic abscess	30.61	10.17	23	92772	916	34863220
Cardio-respiratory arrest	30.50	10.17	63	92732	55210	34808926
Gastrointestinal haemorrhage	30.47	10.17	126	92669	88351	34775785
Renal impairment	29.87	10.17	139	92656	94374	34769762
Blood pressure diastolic decreased	29.75	10.17	71	92724	9023	34855113
Epiphysiolysis	29.51	10.17	11	92784	96	34864040
Secondary adrenocortical insufficiency	29.13	10.17	27	92768	1443	34862693
Meningitis candida	28.61	10.17	10	92785	71	34864065
Crohn's disease	28.21	10.17	38	92757	3079	34861057
Hallucination	27.33	10.17	60	92735	51438	34812698
Subdural haematoma	27.32	10.17	10	92785	20411	34843725
Lichen planus	27.20	10.17	22	92773	977	34863159
Oral disorder	27.18	10.17	44	92751	4205	34859931
Dermatitis atopic	27.16	10.17	50	92745	5297	34858839
Idiopathic intracranial hypertension	27.01	10.17	19	92776	682	34863454
Chorioretinopathy	26.87	10.17	26	92769	1467	34862669
Myelopathy	26.60	10.17	33	92762	2464	34861672
Thyroxine free decreased	26.54	10.17	14	92781	295	34863841
Hypertrophic cardiomyopathy	26.38	10.17	23	92772	1134	34863002
Thermophobia	26.36	10.17	9	92786	59	34864077
Thyrotoxic periodic paralysis	25.98	10.17	11	92784	138	34863998
Pituitary haemorrhage	25.95	10.17	12	92783	188	34863948
Angina pectoris	25.87	10.17	27	92768	31336	34832800
Drug hypersensitivity	25.84	10.17	327	92468	80202	34783934
Feeling cold	25.54	10.17	74	92721	10565	34853571
Respiratory disorder	25.41	10.17	110	92685	19154	34844982
Neuroleptic malignant syndrome	25.35	10.17	8	92787	17926	34846210
Renal failure	24.89	10.17	224	92571	130333	34733803
Rash erythematous	24.53	10.17	131	92664	24846	34839290
Abdominal pain	24.27	10.17	587	92208	163031	34701105
Electrocardiogram QT prolonged	24.04	10.17	45	92750	40907	34823229
Platelet count decreased	23.88	10.17	203	92592	119514	34744622
Posterior reversible encephalopathy syndrome	23.66	10.17	69	92726	9885	34854251
Meningitis tuberculous	22.82	10.17	17	92778	668	34863468
Perioral dermatitis	22.76	10.17	10	92785	138	34863998
Drug ineffective	22.74	10.17	1453	91342	455298	34408838
SARS-CoV-2 test negative	22.70	10.17	20	92775	1000	34863136
Chills	22.65	10.17	321	92474	80722	34783414
Blood growth hormone decreased	22.43	10.17	7	92788	33	34864103
Disease progression	22.13	10.17	182	92613	107895	34756241
Adrenocorticotropic hormone deficiency	21.95	10.17	19	92776	928	34863208
Shared psychotic disorder	21.85	10.17	6	92789	16	34864120
Anal abscess	21.67	10.17	51	92744	6422	34857714
Transplant failure	21.66	10.17	36	92759	3517	34860619
Extrapyramidal disorder	21.61	10.17	4	92791	12876	34851260
Hyperkalaemia	21.36	10.17	103	92692	69286	34794850
Weight fluctuation	20.90	10.17	44	92751	5141	34858995
Blood creatine phosphokinase increased	20.85	10.17	56	92739	44801	34819335
Device dislocation	20.67	10.17	49	92746	6200	34857936
Lactic acidosis	20.60	10.17	38	92757	34734	34829402
Aggression	20.18	10.17	46	92749	38918	34825218
Respiratory depression	20.03	10.17	9	92786	16236	34847900
Strongyloidiasis	20.03	10.17	30	92765	2681	34861455
Weight decreased	20.02	10.17	611	92184	175690	34688446
Musculoskeletal injury	19.99	10.17	9	92786	132	34864004
Coronary artery disease	19.78	10.17	64	92731	48241	34815895
Intentional self-injury	19.72	10.17	6	92789	13765	34850371
Pneumoretroperitoneum	19.64	10.17	9	92786	138	34863998
Symptom masked	19.43	10.17	15	92780	622	34863514
Transient ischaemic attack	19.35	10.17	27	92768	27586	34836550
Gastrointestinal inflammation	19.33	10.17	34	92761	3477	34860659
Cholangitis infective	19.31	10.17	11	92784	271	34863865
Body temperature decreased	19.21	10.17	77	92718	12957	34851179
Stevens-Johnson syndrome	19.16	10.17	99	92696	18540	34845596
Periorbital infection	19.07	10.17	9	92786	148	34863988
Coma	19.06	10.17	60	92735	45618	34818518
Haematochezia	18.98	10.17	198	92597	46336	34817800
Intentional product misuse	18.97	10.17	60	92735	45551	34818585
Skin irritation	18.74	10.17	44	92751	5533	34858603
Optic nerve disorder	18.72	10.17	15	92780	657	34863479
Strabismus	18.64	10.17	23	92772	1708	34862428
Cushingoid	18.59	10.17	29	92766	2685	34861451
Blood growth hormone increased	18.50	10.17	12	92783	376	34863760
Immunosuppressant drug level increased	18.45	10.17	46	92749	6009	34858127
Intestinal intraepithelial lymphocytes increased	18.39	10.17	9	92786	161	34863975
Hospitalisation	18.38	10.17	83	92712	56819	34807317
Pyrexia	18.32	10.17	1069	91726	331944	34532192
Haemorrhoids	18.29	10.17	82	92713	14493	34849643
Depressed level of consciousness	18.07	10.17	56	92739	42785	34821351
Tooth injury	18.05	10.17	19	92776	1186	34862950
Bronchial haemorrhage	18.02	10.17	15	92780	694	34863442
Pruritus	18.01	10.17	499	92296	141482	34722654
Chronic kidney disease	18.00	10.17	53	92742	41157	34822979
Syncope	17.82	10.17	156	92639	91295	34772841
Rhabdomyolysis	17.76	10.17	107	92688	68056	34796080
Candida infection	17.46	10.17	93	92702	17622	34846514
Astrocytoma	17.40	10.17	9	92786	182	34863954
Bradycardia	17.32	10.17	123	92672	75295	34788841
Inflammatory marker increased	17.25	10.17	40	92755	4988	34859148
White blood cell count decreased	17.21	10.17	166	92629	95279	34768857
Body temperature increased	16.99	10.17	91	92704	17277	34846859
Splenic peliosis	16.88	10.17	5	92790	19	34864117
Stress	16.86	10.17	138	92657	30209	34833927
Glioma	16.58	10.17	11	92784	358	34863778
Klebsiella infection	16.46	10.17	55	92740	8476	34855660
Pituitary tumour	16.45	10.17	13	92782	558	34863578
Pouchitis	16.29	10.17	14	92781	677	34863459
Vestibular neuronitis	16.28	10.17	9	92786	209	34863927
Cardiac failure congestive	16.24	10.17	142	92653	83128	34781008
Blood pressure diastolic increased	16.18	10.17	39	92756	4986	34859150
Pharyngitis streptococcal	16.10	10.17	27	92768	2657	34861479
Neuralgia	16.04	10.17	81	92714	15032	34849104
Product quality issue	16.02	10.17	13	92782	17022	34847114
Kounis syndrome	16.00	10.17	26	92769	2492	34861644
Lung consolidation	15.93	10.17	43	92752	5893	34858243
Accidental exposure to product	15.93	10.17	7	92788	12795	34851341
Cryptococcal fungaemia	15.84	10.17	7	92788	98	34864038
Pituitary tumour recurrent	15.84	10.17	7	92788	98	34864038
Clostridium difficile infection	15.84	10.17	95	92700	18803	34845333
Mantle cell lymphoma stage III	15.78	10.17	5	92790	25	34864111
Lacrimal duct neoplasm	15.78	10.17	5	92790	25	34864111
Hyperbilirubinaemia	15.64	10.17	87	92708	16756	34847380
Cryptitis	15.61	10.17	9	92786	227	34863909
Otitis media acute	15.61	10.17	13	92782	602	34863534
Delirium	15.54	10.17	62	92733	43929	34820207
Malignant neoplasm progression	15.51	10.17	154	92641	87892	34776244
Body height below normal	15.40	10.17	9	92786	233	34863903
Aphthous ulcer	15.27	10.17	38	92757	4957	34859179
Diarrhoea haemorrhagic	15.23	10.17	46	92749	6718	34857418
Perineal infection	15.17	10.17	13	92782	626	34863510
Hydrocephalus	15.16	10.17	39	92756	5193	34858943
Melaena	15.10	10.17	46	92749	35334	34828802
Blood thyroid stimulating hormone decreased	15.09	10.17	22	92773	1919	34862217
Posturing	15.05	10.17	12	92783	522	34863614
Eczema herpeticum	14.98	10.17	8	92787	173	34863963
Anaplastic astrocytoma	14.95	10.17	7	92788	113	34864023
Scrotal infection	14.93	10.17	13	92782	640	34863496
Proctalgia	14.90	10.17	41	92754	5682	34858454
Blood pressure systolic increased	14.76	10.17	108	92687	22844	34841292
Gastrointestinal anastomotic leak	14.75	10.17	11	92784	433	34863703
Bladder cancer	14.60	10.17	13	92782	16265	34847871
Back pain	14.60	10.17	425	92370	121364	34742772
Impaired work ability	14.56	10.17	46	92749	6884	34857252
Cerebral infarction	14.55	10.17	32	92763	27423	34836713
Sepsis	14.55	10.17	560	92235	166001	34698135
Wrong technique in product usage process	14.51	10.17	48	92747	35938	34828198
Shunt malfunction	14.46	10.17	8	92787	186	34863950
Rectal haemorrhage	14.45	10.17	167	92628	40082	34824054
Skin exfoliation	14.31	10.17	123	92672	27309	34836827
Disseminated cryptococcosis	14.26	10.17	18	92777	1368	34862768
Microvillous inclusion disease	14.23	10.17	8	92787	192	34863944
Congenital cardiovascular anomaly	14.23	10.17	8	92787	192	34863944
Addison's disease	14.22	10.17	4	92791	12	34864124
Pneumonia	14.17	10.17	803	91992	361824	34502312
Renal disorder	14.09	10.17	29	92766	25451	34838685
Pulmonary arterial hypertension	14.06	10.17	3	92792	8736	34855400
Dyspnoea exertional	14.05	10.17	63	92732	43216	34820920
Perineal pain	14.05	10.17	14	92781	819	34863317
Cryptococcal meningoencephalitis	13.97	10.17	7	92788	132	34864004
Probiotic therapy	13.92	10.17	7	92788	133	34864003
Anaphylactic reaction	13.91	10.17	139	92656	32162	34831974
Dermatitis diaper	13.79	10.17	9	92786	285	34863851
Optic nerve operation	13.79	10.17	11	92784	479	34863657
Abscess	13.73	10.17	65	92730	11752	34852384
Suicidal ideation	13.59	10.17	58	92737	40330	34823806
Lip swelling	13.58	10.17	81	92714	15999	34848137
Glioblastoma multiforme	13.56	10.17	13	92782	725	34863411
Prothrombin level abnormal	13.45	10.17	6	92789	86	34864050
Cardiac disorder	13.28	10.17	64	92731	43062	34821074
Blood creatinine increased	13.26	10.17	175	92620	94801	34769335
Leukopenia	13.24	10.17	105	92690	62751	34801385
Short stature	13.03	10.17	6	92789	93	34864043
Hepatic function abnormal	12.99	10.17	67	92728	44296	34819840
Apnoeic attack	12.93	10.17	10	92785	416	34863720
Cerebrospinal fluid leakage	12.92	10.17	11	92784	525	34863611
Perirectal abscess	12.84	10.17	19	92776	1679	34862457
Product dose omission issue	12.83	10.17	232	92563	119479	34744657
Functional gastrointestinal disorder	12.80	10.17	22	92773	2209	34861927
Adrenal insufficiency neonatal	12.73	10.17	3	92792	3	34864133
Administration site bruise	12.73	10.17	3	92792	3	34864133
Stress at work	12.73	10.17	8	92787	237	34863899
Blood corticotrophin increased	12.70	10.17	6	92789	99	34864037
Rectal abscess	12.68	10.17	17	92778	1371	34862765
Rash	12.59	10.17	717	92078	222035	34642101
Urticaria	12.54	10.17	234	92561	62143	34801993
Serotonin syndrome	12.51	10.17	21	92774	19912	34844224
Cerebral haemorrhage	12.49	10.17	49	92746	34888	34829248
Pharyngeal paraesthesia	12.46	10.17	12	92783	673	34863463
General physical health deterioration	12.39	10.17	253	92542	128016	34736120
Feeling hot	12.37	10.17	91	92704	19281	34844855
Multiple organ dysfunction syndrome	12.35	10.17	278	92517	76288	34787848
Gram stain positive	12.33	10.17	6	92789	106	34864030
Heart rate increased	12.32	10.17	182	92613	46161	34817975
Neurotoxicity	12.31	10.17	86	92709	17924	34846212
Lung neoplasm malignant	12.19	10.17	17	92778	17378	34846758
Phaeochromocytoma crisis	12.16	10.17	5	92790	58	34864078
Anorectal disorder	12.12	10.17	15	92780	1117	34863019
Prostate cancer	12.11	10.17	59	92736	39590	34824546
Cardiac failure chronic	12.09	10.17	3	92792	7876	34856260
Foetal exposure during pregnancy	12.05	10.17	56	92739	38045	34826091
Blood glucose increased	12.04	10.17	116	92679	66602	34797534
Myelitis transverse	12.04	10.17	15	92780	1125	34863011
Liver disorder	11.98	10.17	46	92749	32951	34831185
Short-bowel syndrome	11.94	10.17	8	92787	265	34863871
Blood luteinising hormone decreased	11.93	10.17	6	92789	114	34864022
Incorrect dose administered	11.93	10.17	162	92633	40353	34823783
Neutrophil count decreased	11.90	10.17	83	92712	51021	34813115
Pharyngitis bacterial	11.86	10.17	5	92790	62	34864074
Trichosporon infection	11.76	10.17	12	92783	722	34863414
Agranulocytosis	11.63	10.17	29	92766	23792	34840344
Pallor	11.63	10.17	111	92684	25369	34838767
Hypernatraemia	11.60	10.17	49	92746	8441	34855695
Drug level above therapeutic	11.57	10.17	31	92764	4230	34859906
Coordination abnormal	11.56	10.17	3	92792	7641	34856495
Skin warm	11.53	10.17	21	92774	2206	34861930
Congenital adrenal gland hypoplasia	11.52	10.17	3	92792	6	34864130
Dermal cyst	11.49	10.17	19	92776	1848	34862288
Infected dermal cyst	11.48	10.17	13	92782	881	34863255
Tracheobronchitis	11.48	10.17	14	92781	1027	34863109
Full blood count abnormal	11.41	10.17	20	92775	18648	34845488
Potentiating drug interaction	11.35	10.17	34	92761	4943	34859193
Dry skin	11.31	10.17	130	92665	31157	34832979
Toxic epidermal necrolysis	11.26	10.17	97	92698	21549	34842587
Unmasking of previously unidentified disease	11.25	10.17	13	92782	901	34863235
Rales	11.22	10.17	54	92741	9829	34854307
Chronic sinusitis	11.19	10.17	21	92774	2258	34861878
Mean cell volume decreased	11.18	10.17	16	92779	1372	34862764
Lichenification	11.18	10.17	9	92786	397	34863739
Morganella infection	11.15	10.17	10	92785	512	34863624
Blood corticotrophin decreased	11.15	10.17	7	92788	207	34863929
Arm amputation	11.14	10.17	6	92789	132	34864004
Haemoglobin decreased	11.14	10.17	240	92555	120532	34743604
Skin papilloma	11.11	10.17	20	92775	2083	34862053
Apoptosis	11.08	10.17	9	92786	402	34863734
Antibody test abnormal	11.03	10.17	7	92788	211	34863925
Psychotic disorder	11.01	10.17	31	92764	24421	34839715
Thyroxine decreased	11	10.17	7	92788	212	34863924
Contraindicated product prescribed	10.97	10.17	9	92786	408	34863728
Biopsy	10.95	10.17	8	92787	305	34863831
Gonadotrophin deficiency	10.93	10.17	4	92791	33	34864103
Leptotrichia infection	10.83	10.17	5	92790	78	34864058
Cortisol abnormal	10.82	10.17	4	92791	34	34864102
Mental fatigue	10.71	10.17	6	92789	143	34863993
Metabolic acidosis	10.64	10.17	70	92725	43610	34820526
Type 1 diabetes mellitus	10.59	10.17	30	92765	4228	34859908
Loss of consciousness	10.58	10.17	155	92640	82512	34781624
Pulmonary artery dilatation	10.55	10.17	7	92788	228	34863908
Hypothalamo-pituitary disorder	10.54	10.17	12	92783	818	34863318
Anal haemorrhage	10.54	10.17	22	92773	2556	34861580
Hypothyroidism	10.53	10.17	93	92702	20809	34843327
Defaecation urgency	10.47	10.17	22	92773	2567	34861569
Haematemesis	10.47	10.17	38	92757	27673	34836463
Diplegia	10.30	10.17	13	92782	988	34863148
Delusion	10.28	10.17	11	92784	12624	34851512
Blood culture positive	10.28	10.17	32	92763	4751	34859385
Hypersensitivity	10.28	10.17	223	92572	60812	34803324
Unevaluable event	10.24	10.17	48	92747	32542	34831594
Liver function test abnormal	10.23	10.17	45	92750	31029	34833107
Dizziness	10.21	10.17	475	92320	218046	34646090
Necrotising bronchiolitis	10.21	10.17	3	92792	11	34864125
Job dissatisfaction	10.21	10.17	6	92789	157	34863979
Skin lesion	10.19	10.17	96	92699	21865	34842271

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
Completed suicide	683.46	9.47	21	252810	245746	79245811
Intentional product use issue	648.06	9.47	1466	251365	150646	79340911
Toxicity to various agents	558.25	9.47	322	252509	421218	79070339
Infusion related reaction	541.48	9.47	1783	251048	228454	79263103
Pericarditis	449.72	9.47	1010	251821	103226	79388331
Drug abuse	448.25	9.47	15	252816	162676	79328881
Wound	446.79	9.47	1076	251755	115103	79376454
Anti-cyclic citrullinated peptide antibody positive	441.55	9.47	877	251954	82266	79409291
Glossodynia	433.26	9.47	990	251841	102347	79389210
Duodenal ulcer perforation	428.32	9.47	760	252071	65451	79426106
Systemic lupus erythematosus	412.28	9.47	1071	251760	120078	79371479
Pemphigus	411.93	9.47	949	251882	98633	79392924
Helicobacter infection	404.02	9.47	763	252068	68941	79422616
Hand deformity	386.25	9.47	950	251881	102969	79388588
Discomfort	365.05	9.47	1048	251783	124569	79366988
Adrenocortical insufficiency acute	353.50	9.47	179	252652	2864	79488693
Rheumatoid factor positive	346.75	9.47	655	252176	59184	79432373
Death	335.87	9.47	819	252012	565695	78925862
Inappropriate schedule of product administration	314.77	9.47	1036	251795	132592	79358965
Blood pressure fluctuation	297.80	9.47	658	252173	66487	79425070
Adrenal insufficiency	282.78	9.47	398	252433	28089	79463468
Blister	270.44	9.47	914	251917	118562	79372995
Synovitis	267.80	9.47	1066	251765	149668	79341889
Rheumatic fever	258.97	9.47	382	252449	28143	79463414
Drug interaction	247.53	9.47	598	252233	414585	79076972
Off label use	245.39	9.47	4135	248696	903080	78588477
Arthropathy	237.31	9.47	1151	251680	175960	79315597
Condition aggravated	234.34	9.47	2523	250308	498601	78992956
Product use issue	230.31	9.47	1290	251541	208532	79283025
Alopecia	222.07	9.47	1373	251458	229982	79261575
Swelling	220	9.47	1305	251526	215406	79276151
Irritable bowel syndrome	213.39	9.47	552	252279	61689	79429868
Folliculitis	209.62	9.47	510	252321	54870	79436687
Intentional overdose	208.88	9.47	41	252790	105919	79385638
Fall	203.92	9.47	825	252006	486804	79004753
Overdose	200.88	9.47	173	252658	184033	79307524
Colitis ulcerative	200.86	9.47	380	252451	34362	79457195
Abdominal discomfort	200.69	9.47	1422	251409	249305	79242252
Hepatic enzyme increased	200.56	9.47	1123	251708	181487	79310070
Hypersensitivity	200.52	9.47	1471	251360	260768	79230789
Craniopharyngioma	192.17	9.47	65	252766	335	79491222
Maternal exposure during pregnancy	189.84	9.47	897	251934	135641	79355916
Swollen joint count increased	189.61	9.47	294	252537	22633	79468924
Acute kidney injury	181.85	9.47	938	251893	518466	78973091
Muscle injury	177.20	9.47	441	252390	48120	79443437
Steroid withdrawal syndrome	154.89	9.47	65	252766	656	79490901
Blood cholesterol increased	153.36	9.47	598	252233	83122	79408435
Frequent bowel movements	150.04	9.47	306	252525	29233	79462324
Sleep disorder due to general medical condition, insomnia type	147.96	9.47	385	252446	43171	79448386
Type 2 diabetes mellitus	144.49	9.47	454	252377	56668	79434889
Drug level below therapeutic	142.01	9.47	165	252666	9605	79481952
Hip arthroplasty	139.28	9.47	333	252498	35423	79456134
Fibromyalgia	133.17	9.47	478	252353	63862	79427695
Interstitial lung disease	132.44	9.47	98	252733	112502	79379055
Drug intolerance	130.72	9.47	1346	251485	262773	79228784
Secondary immunodeficiency	128.99	9.47	96	252735	3138	79488419
Injury	127.96	9.47	536	252295	76960	79414597
Anaemia	126.27	9.47	859	251972	444156	79047401
Weight increased	126.25	9.47	1390	251441	275996	79215561
Drug hypersensitivity	114.85	9.47	1450	251381	297466	79194091
Suicide attempt	112.90	9.47	61	252770	82871	79408686
Faecal calprotectin increased	111.21	9.47	111	252720	5430	79486127
Impaired healing	109.72	9.47	559	252272	87096	79404461
Rash	109.16	9.47	2499	250332	575859	78915698
Myocardial infarction	108.11	9.47	267	252564	183862	79307695
Deep vein thrombosis postoperative	107.85	9.47	151	252680	10601	79480956
Sedation	104.56	9.47	19	252812	51876	79439681
Atrial fibrillation	99.75	9.47	309	252522	197577	79293980
Lip dry	98.38	9.47	176	252655	15242	79476315
Heart rate irregular	98.09	9.47	276	252555	32403	79459154
Facet joint syndrome	97.77	9.47	148	252683	11154	79480403
Liver injury	97.72	9.47	397	252434	56217	79435340
Psoriatic arthropathy	96.63	9.47	496	252335	77503	79414054
Contraindicated product administered	95.33	9.47	838	251993	156700	79334857
Lower respiratory tract infection	94.72	9.47	718	252113	128502	79363055
Cardio-respiratory arrest	91.57	9.47	126	252705	108384	79383173
Coma	90.98	9.47	111	252720	100538	79391019
Pituitary tumour benign	90.72	9.47	71	252760	2505	79489052
Cardiac failure	90.52	9.47	225	252606	154617	79336940
Gastrointestinal haemorrhage	89.24	9.47	211	252620	147508	79344049
Knee arthroplasty	88.38	9.47	320	252511	42928	79448629
Renal impairment	86.34	9.47	237	252594	157546	79334011
Autoimmune disorder	85.44	9.47	173	252658	16439	79475118
Febrile bone marrow aplasia	84.84	9.47	150	252681	12870	79478687
Body temperature fluctuation	83.38	9.47	80	252751	3727	79487830
Hypopituitarism	83.24	9.47	76	252755	3323	79488234
Syncope	83.00	9.47	291	252540	179158	79312399
Heart rate decreased	82.86	9.47	441	252390	69875	79421682
Therapeutic response shortened	80.17	9.47	164	252667	15699	79475858
Anal fissure	78.48	9.47	109	252722	7594	79483963
Aplastic anaemia	77.69	9.47	174	252657	17731	79473826
Platelet count decreased	77.65	9.47	335	252496	194329	79297228
Product dose omission issue	77.16	9.47	464	252367	247073	79244484
Secondary adrenocortical insufficiency	76.97	9.47	69	252762	2945	79488612
Live birth	76.73	9.47	178	252653	18566	79472991
Peripheral venous disease	76.32	9.47	161	252670	15748	79475809
Diabetes insipidus	75.37	9.47	88	252743	5149	79486408
Cortisol decreased	74.62	9.47	59	252772	2113	79489444
Therapeutic product effect decreased	74.40	9.47	821	252010	163042	79328515
Poor venous access	73.91	9.47	172	252659	17977	79473580
Depressed level of consciousness	73.07	9.47	121	252710	96531	79395026
Stomatitis	73.03	9.47	749	252082	146008	79345549
Intentional product misuse	73.01	9.47	118	252713	95047	79396510
Arthralgia	71.97	9.47	2345	250486	569458	78922099
Adjustment disorder with depressed mood	71.64	9.47	114	252717	8972	79482585
Cardiac failure congestive	70.59	9.47	224	252607	142178	79349379
Electrocardiogram QT prolonged	70.35	9.47	111	252720	90275	79401282
Joint swelling	70.03	9.47	1295	251536	287351	79204206
Bradycardia	69.48	9.47	210	252621	135347	79356210
Fistula	69.23	9.47	137	252694	12803	79478754
Steroid dependence	68.73	9.47	61	252770	2569	79488988
Disease progression	68.30	9.47	326	252505	184036	79307521
Respiratory arrest	67.77	9.47	50	252781	57500	79434057
Leukoencephalopathy	67.41	9.47	103	252728	7826	79483731
Human bocavirus infection	67.17	9.47	37	252794	708	79490849
Pneumonia	66.55	9.47	1590	251241	658656	78832901
Haemoglobin decreased	66.28	9.47	422	252409	221697	79269860
Drug specific antibody present	66.09	9.47	93	252738	6559	79484998
Mycobacterium chelonae infection	64.26	9.47	57	252774	2399	79489158
Lactic acidosis	64.21	9.47	77	252754	70282	79421275
Cognitive disorder	63.31	9.47	77	252754	69849	79421708
Serotonin syndrome	62.93	9.47	32	252799	44995	79446562
Full blood count abnormal	62.45	9.47	25	252806	40449	79451108
Treatment failure	62.42	9.47	820	252011	169666	79321891
Ill-defined disorder	61.85	9.47	389	252442	65486	79426071
Hypofibrinogenaemia	61.62	9.47	51	252780	1951	79489606
Bacterial infection	61.01	9.47	228	252603	31052	79460505
Intentional self-injury	60.89	9.47	14	252817	32405	79459152
Febrile neutropenia	60.48	9.47	1049	251782	229950	79261607
White blood cell count decreased	59.68	9.47	351	252480	187937	79303620
Blood creatine phosphokinase increased	58.55	9.47	74	252757	66016	79425541
Blood creatinine increased	58.12	9.47	273	252558	154784	79336773
Device expulsion	57.78	9.47	7	252824	25854	79465703
Drug level decreased	57.02	9.47	135	252696	14267	79477290
Anti-cyclic citrullinated peptide antibody	56.94	9.47	81	252750	5771	79485786
Malignant neoplasm progression	56.71	9.47	230	252601	135760	79355797
Neutropenia	56.11	9.47	612	252219	287098	79204459
Neoplasm recurrence	56.02	9.47	68	252763	4146	79487411
Prescribed overdose	55.63	9.47	253	252578	37630	79453927
Leukopenia	55.17	9.47	187	252644	116326	79375231
Pruritus	53.64	9.47	1634	251197	393014	79098543
Neuroleptic malignant syndrome	53.59	9.47	11	252820	27548	79464009
Melaena	53.09	9.47	69	252762	60821	79430736
Exposure during pregnancy	51.66	9.47	519	252312	100613	79390944
Renal failure	51.52	9.47	399	252432	200569	79290988
Nasopharyngitis	51.50	9.47	1109	251722	252772	79238785
Hepatic function abnormal	50.33	9.47	97	252734	73010	79418547
Adrenal suppression	50.22	9.47	39	252792	1360	79490197
Cerebrovascular accident	50.00	9.47	288	252543	155004	79336553
Urticaria	49.90	9.47	845	251986	184356	79307201
Adverse event	49.52	9.47	344	252487	59870	79431687
Pseudostroke	49.43	9.47	16	252815	70	79491487
Hyperkalaemia	48.00	9.47	193	252638	114205	79377352
Dislocation of vertebra	47.79	9.47	88	252743	7792	79483765
Eczema	47.40	9.47	255	252576	40563	79450994
Norovirus test positive	46.64	9.47	28	252803	634	79490923
Wrong technique in product usage process	46.64	9.47	103	252728	73772	79417785
Breast cancer stage III	46.63	9.47	99	252732	9727	79481830
Anal fistula	46.54	9.47	81	252750	6863	79484694
Cardiac arrest	46.33	9.47	337	252494	171759	79319798
Lower limb fracture	45.93	9.47	170	252661	23045	79468512
Perioral dermatitis	45.92	9.47	23	252808	359	79491198
Hypophysitis	45.54	9.47	61	252770	4105	79487452
Gastrointestinal disorder	45.23	9.47	589	252242	121616	79369941
Meningitis candida	44.95	9.47	17	252814	127	79491430
Maternal exposure timing unspecified	44.74	9.47	72	252759	5720	79485837
Wheezing	44.74	9.47	566	252265	116098	79375459
Suicidal ideation	44.54	9.47	111	252720	76229	79415328
Rhabdomyolysis	44.53	9.47	172	252659	102959	79388598
Hepatotoxicity	43.95	9.47	59	252772	51293	79440264
Hallucination	43.81	9.47	133	252698	85612	79405945
Thrombocytopenia	42.71	9.47	588	252243	264671	79226886
Nausea	42.15	9.47	2546	250285	954650	78536907
Insulin-like growth factor decreased	41.88	9.47	25	252806	560	79490997
Transient ischaemic attack	41.68	9.47	64	252767	52631	79438926
Metabolic acidosis	41.46	9.47	129	252702	82400	79409157
Thymus hypoplasia	41.33	9.47	30	252801	943	79490614
Accidental exposure to product	41.23	9.47	24	252807	31298	79460259
Insulin-like growth factor increased	40.12	9.47	39	252792	1847	79489710
Joint range of motion decreased	40.06	9.47	210	252621	33072	79458485
Adverse drug reaction	40.04	9.47	353	252478	66039	79425518
Loss of consciousness	40.03	9.47	340	252491	167603	79323954
Cystitis bacterial	39.87	9.47	26	252805	684	79490873
Respiratory depression	39.57	9.47	19	252812	27611	79463946
Female genital tract fistula	39.14	9.47	69	252762	5906	79485651
Human herpesvirus 6 infection	39.11	9.47	65	252766	5305	79486252
Balance disorder	38.86	9.47	171	252660	98686	79392871
Contusion	38.68	9.47	675	252156	148101	79343456
Somnolence	38.37	9.47	530	252301	238451	79253106
Lymphoid tissue hypoplasia	37.97	9.47	28	252803	902	79490655
Tendon pain	37.92	9.47	66	252765	5592	79485965
Night sweats	37.88	9.47	289	252542	51806	79439751
Poisoning deliberate	37.70	9.47	7	252824	18821	79472736
Pseudomonal sepsis	37.51	9.47	69	252762	6105	79485452
Orthostatic hypotension	37.38	9.47	76	252755	56088	79435469
Anal inflammation	37.04	9.47	33	252798	1397	79490160
Clostridium difficile colitis	37.02	9.47	201	252630	32082	79459475
Hypotension	36.99	9.47	1088	251743	439229	79052328
Extrapyramidal disorder	36.68	9.47	13	252818	22666	79468891
Cardiac disorder	36.53	9.47	98	252733	65659	79425898
Rhinovirus infection	36.44	9.47	79	252752	7874	79483683
C-reactive protein	35.90	9.47	60	252771	4919	79486638
Hypothalamo-pituitary disorder	35.89	9.47	30	252801	1164	79490393
Haematuria	35.72	9.47	106	252725	68730	79422827
Chronic kidney disease	35.70	9.47	100	252731	66054	79425503
Musculoskeletal stiffness	35.63	9.47	765	252066	174243	79317314
Pulmonary arterial hypertension	35.58	9.47	23	252808	28343	79463214
Injection site erythema	35.33	9.47	128	252703	78069	79413488
Parainfluenzae virus infection	35.15	9.47	64	252767	5618	79485939
Strongyloidiasis	35.08	9.47	52	252779	3846	79487711
Schizophrenia	34.94	9.47	4	252827	15436	79476121
Subdural haematoma	34.87	9.47	29	252802	31405	79460152
Drug level above therapeutic	34.79	9.47	82	252749	8641	79482916
Myelosuppression	34.78	9.47	46	252785	40250	79451307
Grip strength decreased	34.33	9.47	149	252682	21720	79469837
Acute myocardial infarction	34.22	9.47	127	252704	76909	79414648
Blood pressure increased	33.63	9.47	893	251938	210467	79281090
Parkinsonism	33.56	9.47	6	252825	16578	79474979
Coronary artery disease	33.13	9.47	102	252729	65372	79426185
Anal abscess	33.11	9.47	84	252747	9271	79482286
Hypogonadism	33.03	9.47	34	252797	1726	79489831
X-ray abnormal	32.87	9.47	63	252768	5750	79485807
Eczema herpeticum	32.55	9.47	17	252814	291	79491266
Pituitary haemorrhage	32.39	9.47	17	252814	294	79491263
Sciatica	32.32	9.47	198	252633	33024	79458533
Septic shock	32.22	9.47	558	252273	122243	79369314
Shared psychotic disorder	32.21	9.47	10	252821	37	79491520
Agitation	32.05	9.47	185	252646	99530	79392027
Soft tissue mass	31.93	9.47	29	252802	1259	79490298
Bladder cancer	31.91	9.47	11	252820	19515	79472042
Wound infection	31.41	9.47	155	252676	23836	79467721
Bursitis	31.39	9.47	208	252623	35636	79455921
Hospitalisation	31.28	9.47	173	252658	94063	79397494
International normalised ratio increased	31.24	9.47	150	252681	84571	79406986
Aspartate aminotransferase increased	31.12	9.47	285	252546	138356	79353201
Chronic obstructive pulmonary disease	31.06	9.47	152	252679	85267	79406290
Osteonecrosis of jaw	30.94	9.47	56	252775	43170	79448387
Liver function test abnormal	30.84	9.47	103	252728	64372	79427185
Unevaluable event	30.75	9.47	83	252748	55502	79436055
Arrhythmia	30.62	9.47	96	252735	61176	79430381
Perfume sensitivity	30.46	9.47	24	252807	855	79490702
Pituitary tumour recurrent	30.44	9.47	14	252817	179	79491378
Alanine aminotransferase increased	30.40	9.47	349	252482	162221	79329336
Hyperadrenocorticism	30.19	9.47	17	252814	340	79491217
Hypercalcaemia	30.08	9.47	47	252784	38383	79453174
Aggression	29.80	9.47	74	252757	50884	79440673
Proctalgia	29.55	9.47	84	252747	9917	79481640
Injection site swelling	29.51	9.47	66	252765	47066	79444491
Lupus vulgaris	29.20	9.47	44	252787	3302	79488255
Cerebral haemorrhage	29.07	9.47	90	252741	57583	79433974
Incorrect dose administered	29.04	9.47	371	252460	76259	79415298
Impaired quality of life	29.01	9.47	106	252725	14280	79477277
Road traffic accident	28.88	9.47	237	252594	43427	79448130
Breast cancer	28.71	9.47	39	252792	33742	79457815
Fluid retention	28.51	9.47	119	252712	69690	79421867
Neutrophil count decreased	28.26	9.47	178	252653	93781	79397776
Mucosal inflammation	28.26	9.47	365	252466	75215	79416342
Colitis	28.24	9.47	356	252475	72951	79418606
Angina pectoris	28.06	9.47	78	252753	51654	79439903
Product prescribing error	27.86	9.47	63	252768	44750	79446807
Injection site pain	27.82	9.47	270	252561	129568	79361989
Infection	27.44	9.47	980	251851	240732	79250825
Multimorbidity	27.37	9.47	28	252803	1411	79490146
Drug resistance	27.35	9.47	58	252773	42155	79449402
Blood glucose increased	27.28	9.47	233	252598	114742	79376815
Salpingo-oophorectomy unilateral	27.26	9.47	22	252809	812	79490745
Hypoaesthesia	27.16	9.47	753	252078	178599	79312958
Oesophageal perforation	27.07	9.47	29	252802	1542	79490015
Jaundice	27.07	9.47	83	252748	53266	79438291
Cerebral infarction	26.97	9.47	66	252765	45610	79445947
Growth retardation	26.89	9.47	32	252799	1911	79489646
Urticaria thermal	26.72	9.47	17	252814	428	79491129
Upper gastrointestinal haemorrhage	26.69	9.47	57	252774	41323	79450234
Sleep disorder	26.47	9.47	400	252431	85277	79406280
Pneumatosis intestinalis	26.46	9.47	61	252770	6336	79485221
Chronic sinusitis	26.28	9.47	96	252735	12930	79478627
Haematochezia	25.85	9.47	406	252425	87239	79404318
Creatinine renal clearance decreased	25.82	9.47	14	252817	18988	79472569
Lung neoplasm malignant	25.80	9.47	30	252801	27762	79463795
Dermatitis atopic	25.48	9.47	80	252751	9976	79481581
Toxic skin eruption	25.44	9.47	20	252811	22273	79469284
Dyskinesia	25.42	9.47	66	252765	44707	79446850
Enterobacter infection	25.25	9.47	49	252782	4513	79487044
Pneumoretroperitoneum	25.12	9.47	12	252819	168	79491389
Agranulocytosis	25.09	9.47	67	252764	44963	79446594
Delusion	25.02	9.47	17	252814	20406	79471151
Red blood cell sedimentation rate abnormal	24.96	9.47	18	252813	20945	79470612
Body temperature decreased	24.89	9.47	181	252650	31964	79459593
Therapy cessation	24.85	9.47	51	252780	37511	79454046
Therapy interrupted	24.85	9.47	38	252793	31303	79460254
Mobility decreased	24.84	9.47	534	252297	121641	79369916
Thermophobia	24.80	9.47	9	252822	59	79491498
Erythema nodosum	24.57	9.47	53	252778	5264	79486293
Injection site reaction	24.54	9.47	90	252741	54695	79436862
Natural killer-cell leukaemia	24.36	9.47	10	252821	95	79491462
Pulmonary hypertension	24.26	9.47	75	252756	48005	79443552
Metastases to bone	24.18	9.47	25	252806	24402	79467155
Walking aid user	24.14	9.47	79	252752	10069	79481488
Drug withdrawal syndrome	23.95	9.47	46	252785	34672	79456885
Tremor	23.91	9.47	387	252444	169696	79321861
Hypomagnesaemia	23.79	9.47	73	252758	46838	79444719
Hyperhidrosis	23.58	9.47	338	252493	151154	79340403
Epidural lipomatosis	23.55	9.47	24	252807	1204	79490353
Asthenia	23.49	9.47	1355	251476	510334	78981223
Candida infection	23.46	9.47	204	252627	38010	79453547
Obesity	23.42	9.47	191	252640	34934	79456623
Renal disorder	23.20	9.47	63	252768	42042	79449515
Multiple sclerosis relapse	23.18	9.47	73	252758	46460	79445097
Hypothalamic pituitary adrenal axis suppression	23.17	9.47	14	252817	321	79491236
Skin ulcer	22.93	9.47	91	252740	54059	79437498
Epiphysiolysis	22.91	9.47	10	252821	112	79491445
Myelodysplastic syndrome	22.83	9.47	38	252793	30263	79461294
Dysarthria	22.52	9.47	124	252707	67498	79424059
Sinusitis	22.51	9.47	794	252037	194707	79296850
Vaginal discharge	22.36	9.47	63	252768	7400	79484157
Astrocytoma	22.29	9.47	12	252819	219	79491338
Pneumonia aspiration	22.19	9.47	123	252708	66844	79424713
Rheumatoid nodule	22.06	9.47	14	252817	17424	79474133
Abdominal pain	22.03	9.47	1475	251356	388094	79103463
Psychotic disorder	22.03	9.47	63	252768	41339	79450218
Blood potassium increased	21.79	9.47	37	252794	29238	79462319
Pulmonary oedema	21.77	9.47	177	252654	88077	79403480
Proteinuria	21.61	9.47	44	252787	32458	79459099
Normal tension glaucoma	21.36	9.47	8	252823	58	79491499
Defaecation urgency	21.35	9.47	53	252778	5771	79485786
Viraemia	21.26	9.47	35	252796	2834	79488723
Oedema peripheral	21.25	9.47	623	252208	251665	79239892
Femur fracture	21.17	9.47	58	252773	38594	79452963
Adrenocorticotropic hormone deficiency	21.16	9.47	24	252807	1361	79490196
Abscess bacterial	21.11	9.47	19	252812	815	79490742
Mucous stools	21.10	9.47	49	252782	5113	79486444
Musculoskeletal injury	21.07	9.47	11	252820	188	79491369
Epistaxis	21.00	9.47	239	252592	111276	79380281
Tendon disorder	20.89	9.47	60	252771	7126	79484431
Blood corticotrophin decreased	20.85	9.47	16	252815	548	79491009
Ventricular tachycardia	20.74	9.47	66	252765	41869	79449688
Atrial flutter	20.45	9.47	23	252808	21602	79469955
Thyrotoxic periodic paralysis	20.26	9.47	10	252821	151	79491406
Herpes zoster	20.18	9.47	193	252638	92890	79398667
Muscle rigidity	20.08	9.47	20	252811	19862	79471695
Blood alkaline phosphatase increased	19.98	9.47	119	252712	63545	79428012
Flushing	19.98	9.47	392	252439	87876	79403681
Blood pressure diastolic decreased	19.98	9.47	164	252667	30052	79461505
Dyspnoea exertional	19.97	9.47	178	252653	86895	79404662
Enthesopathy	19.92	9.47	6	252825	11602	79479955
Diarrhoea haemorrhagic	19.89	9.47	89	252742	13145	79478412
Accidental overdose	19.78	9.47	62	252769	39519	79452038
Gait inability	19.75	9.47	279	252552	58638	79432919
Drug reaction with eosinophilia and systemic symptoms	19.68	9.47	121	252710	64123	79427434
Enteritis	19.65	9.47	95	252736	14488	79477069
Dizziness	19.55	9.47	1421	251410	525020	78966537
Device difficult to use	19.48	9.47	9	252822	13376	79478181
Blood urea increased	19.41	9.47	84	252747	48706	79442851
Dyspnoea	19.36	9.47	2401	250430	854624	78636933
Eosinophilia	19.33	9.47	76	252755	45269	79446288
Pain	19.32	9.47	2530	250301	701272	78790285
Allergy test positive	19.25	9.47	17	252814	711	79490846
Herpes simplex oesophagitis	19.22	9.47	13	252818	364	79491193
Myelopathy	18.96	9.47	44	252787	4589	79486968
Feeling abnormal	18.96	9.47	373	252458	158826	79332731
Bronchitis	18.78	9.47	296	252535	130348	79361209
Ischaemic stroke	18.68	9.47	49	252782	33082	79458475
Panniculitis	18.51	9.47	8	252823	12363	79479194
Hallucination, auditory	18.50	9.47	23	252808	20670	79470887
Drug eruption	18.50	9.47	74	252757	43861	79447696
Haematoma	18.33	9.47	94	252737	52101	79439456
Blood corticotrophin increased	18.31	9.47	10	252821	188	79491369
White blood cell count increased	18.26	9.47	150	252681	74483	79417074
Urinary retention	18.23	9.47	105	252726	56525	79435032
Dry skin	18.20	9.47	310	252521	67685	79423872
Atrioventricular block	18.14	9.47	11	252820	14030	79477527
Bone marrow failure	17.97	9.47	92	252739	51015	79440542
Sedation complication	17.95	9.47	14	252817	15655	79475902
Diffuse large B-cell lymphoma	17.95	9.47	8	252823	12141	79479416
Palmar-plantar erythrodysaesthesia syndrome	17.94	9.47	50	252781	33084	79458473
Airway peak pressure increased	17.81	9.47	12	252819	334	79491223
Symptom masked	17.78	9.47	22	252809	1368	79490189
Colorectal cancer	17.78	9.47	3	252828	8644	79482913
Dehydration	17.75	9.47	626	252205	247561	79243996
Haematotoxicity	17.61	9.47	14	252817	15505	79476052
Hyperemesis gravidarum	17.47	9.47	13	252818	425	79491132
Angina unstable	17.42	9.47	16	252815	16511	79475046
Gastrointestinal inflammation	17.30	9.47	58	252773	7486	79484071
Pituitary infarction	17.29	9.47	7	252824	64	79491493
Pharyngeal paraesthesia	17.28	9.47	31	252800	2690	79488867
Cerebrospinal fluid leakage	17.25	9.47	24	252807	1675	79489882
Right ventricular failure	17.21	9.47	30	252801	23467	79468090
Granuloma skin	17.15	9.47	4	252827	9170	79482387
Loss of employment	17.11	9.47	30	252801	2557	79489000
Mitral valve incompetence	17.08	9.47	41	252790	28524	79463033
Musculoskeletal disorder	17.01	9.47	26	252805	21422	79470135
Cardiac failure chronic	16.98	9.47	7	252824	11128	79480429
Adrenal disorder	16.97	9.47	27	252804	2124	79489433
Cardiac failure acute	16.97	9.47	21	252810	18908	79472649
Anticipatory anxiety	16.94	9.47	20	252811	1184	79490373
Systemic infection	16.81	9.47	5	252826	9747	79481810
Osteomyelitis	16.77	9.47	51	252780	32814	79458743
Gastroenteritis norovirus	16.76	9.47	33	252798	3073	79488484
Myalgia	16.75	9.47	454	252377	185187	79306370
Catarrh	16.72	9.47	27	252804	2151	79489406
Prostate cancer	16.71	9.47	52	252779	33216	79458341
Acute generalised exanthematous pustulosis	16.70	9.47	18	252813	17236	79474321
Pancytopenia	16.65	9.47	399	252432	165346	79326211
Glioblastoma multiforme	16.62	9.47	20	252811	1208	79490349
Osteoarthritis	16.60	9.47	378	252453	86931	79404626
Hypernatraemia	16.59	9.47	90	252741	14361	79477196
Underdose	16.52	9.47	52	252779	33099	79458458
Pyoderma gangrenosum	16.49	9.47	39	252792	4119	79487438
Intestinal intraepithelial lymphocytes increased	16.39	9.47	9	252822	171	79491386
Thrombosis	16.32	9.47	179	252652	83921	79407636
Sinusitis fungal	16.31	9.47	28	252803	2346	79489211
Breast cancer female	16.23	9.47	8	252823	11453	79480104
Blepharospasm	16.19	9.47	48	252783	5803	79485754
Oedema	16.16	9.47	495	252336	119085	79372472
Splenic peliosis	16.00	9.47	5	252826	19	79491538
Altered state of consciousness	15.92	9.47	78	252753	43744	79447813
Atrioventricular block first degree	15.84	9.47	10	252821	12481	79479076
Miosis	15.81	9.47	16	252815	15773	79475784
Rheumatoid arthritis	15.79	9.47	522	252309	207948	79283609
Viral infection	15.76	9.47	207	252624	42809	79448748
Kounis syndrome	15.73	9.47	39	252792	4243	79487314
Weight decreased	15.72	9.47	1319	251512	353879	79137678
Product quality issue	15.70	9.47	55	252776	33885	79457672
Apathy	15.64	9.47	11	252820	12966	79478591
Product use in unapproved indication	15.60	9.47	956	251875	249403	79242154
Skin fragility	15.57	9.47	17	252814	924	79490633
Glioma	15.41	9.47	14	252817	608	79490949
Tooth injury	15.38	9.47	25	252806	2003	79489554
Mydriasis	15.37	9.47	20	252811	17623	79473934
Blood bilirubin increased	15.36	9.47	135	252696	66097	79425460
Tenosynovitis	15.31	9.47	16	252815	15538	79476019
Pregnancy	15.28	9.47	141	252690	26710	79464847
Blood growth hormone increased	15.24	9.47	15	252816	721	79490836
Renal cancer	15.22	9.47	10	252821	12216	79479341
Therapeutic reaction time decreased	15.16	9.47	34	252797	3467	79488090
Metastases to liver	15.12	9.47	43	252788	28271	79463286
Unmasking of previously unidentified disease	15.12	9.47	25	252806	2032	79489525
Blood calcium decreased	15.10	9.47	51	252780	31768	79459789
Pleural effusion	15.06	9.47	348	252483	144914	79346643
Oxygen saturation abnormal	15.04	9.47	40	252791	4542	79487015
Mastocytosis	15.03	9.47	13	252818	529	79491028
Akathisia	15.00	9.47	12	252819	13247	79478310
Tendon rupture	14.93	9.47	77	252754	12049	79479508
Abnormal behaviour	14.92	9.47	62	252769	36359	79455198
Cerebral microangiopathy	14.88	9.47	10	252821	277	79491280
Pouchitis	14.87	9.47	17	252814	972	79490585
Granulocytopenia	14.71	9.47	9	252822	11422	79480135
Electrocardiogram QRS complex prolonged	14.69	9.47	8	252823	10825	79480732
Morganella infection	14.68	9.47	18	252813	1109	79490448
Pulmonary embolism	14.66	9.47	423	252408	171231	79320326
Migraine	14.58	9.47	372	252459	87121	79404436
Acute graft versus host disease	14.55	9.47	7	252824	10160	79481397
Natural killer cell count decreased	14.52	9.47	6	252825	58	79491499
Anorectal disorder	14.40	9.47	26	252805	2267	79489290
Aphasia	14.33	9.47	88	252743	46644	79444913
Excessive eye blinking	14.32	9.47	22	252809	1679	79489878
Lichen planus	14.27	9.47	29	252802	2762	79488795
Burns second degree	14.27	9.47	28	252803	2600	79488957
Gamma-glutamyltransferase increased	14.26	9.47	108	252723	54572	79436985
Vertigo	14.23	9.47	145	252686	68937	79422620
Dystonia	14.20	9.47	29	252802	21370	79470187
Tongue disorder	14.18	9.47	14	252817	13961	79477596
Oropharyngeal pain	14.07	9.47	450	252381	108903	79382654
Anaplastic astrocytoma	14.03	9.47	8	252823	164	79491393
Seizure	14.03	9.47	474	252357	188360	79303197
Hepatic cancer	13.96	9.47	8	252823	10521	79481036
Exposure to SARS-CoV-2	13.90	9.47	24	252807	2020	79489537
Dermatitis diaper	13.90	9.47	10	252821	310	79491247
Ventricular hypokinesia	13.88	9.47	6	252825	9273	79482284
C-reactive protein abnormal	13.86	9.47	223	252608	48144	79443413
Strabismus	13.86	9.47	27	252804	2494	79489063
Abdominal pain upper	13.82	9.47	854	251977	222965	79268592
Cerebral vasoconstriction	13.79	9.47	20	252811	1450	79490107
Faecaloma	13.67	9.47	10	252821	11554	79480003
Weight fluctuation	13.59	9.47	73	252758	11602	79479955
Hypercholesterolaemia	13.51	9.47	122	252709	22973	79468584
Proctitis	13.48	9.47	48	252783	6384	79485173
Red blood cell count decreased	13.44	9.47	117	252714	57396	79434161
SARS-CoV-2 test negative	13.37	9.47	19	252812	1352	79490205
Autoimmune nephritis	13.37	9.47	14	252817	725	79490832
Purpura	13.36	9.47	26	252805	19501	79472056
Myoclonus	13.35	9.47	44	252787	27616	79463941
Tubulointerstitial nephritis	13.35	9.47	69	252762	38166	79453391
Peptic ulcer haemorrhage	13.32	9.47	16	252815	965	79490592
Atrioventricular block complete	13.30	9.47	20	252811	16590	79474967
Germ cell cancer	13.29	9.47	8	252823	182	79491375
Coronavirus infection	13.27	9.47	53	252778	7444	79484113
Haematemesis	13.27	9.47	104	252727	52160	79439397
Hyperreflexia	13.23	9.47	5	252826	8380	79483177
Hypertension	13.23	9.47	1220	251611	329772	79161785
Transplant rejection	13.19	9.47	26	252805	19411	79472146
Cortisol abnormal	13.16	9.47	6	252825	75	79491482
Excessive skin	13.14	9.47	7	252824	125	79491432
Gingival pain	13.14	9.47	60	252771	8938	79482619
Nasal polyps	13.13	9.47	52	252779	7275	79484282
Cholestasis	13.08	9.47	104	252727	52005	79439552
Pseudohypoaldosteronism	13.04	9.47	5	252826	39	79491518
Blood potassium decreased	13.03	9.47	90	252741	46422	79445135
Shunt malfunction	13	9.47	9	252822	262	79491295
Therapy partial responder	12.94	9.47	22	252809	17375	79474182
Ulcer	12.92	9.47	50	252781	29922	79461635
Duodenal ulcer	12.83	9.47	20	252811	16349	79475208
Dysphagia	12.83	9.47	292	252539	121844	79369713
Ventricular arrhythmia	12.78	9.47	6	252825	8834	79482723
Haemorrhoids	12.77	9.47	145	252686	28983	79462574
Bone disorder	12.60	9.47	26	252805	19087	79472470
Product storage error	12.55	9.47	20	252811	16206	79475351
Restlessness	12.52	9.47	91	252740	46401	79445156
Drug ineffective	12.52	9.47	3722	249109	1077191	78414366
Haemorrhagic stroke	12.49	9.47	10	252821	11036	79480521
Glomerular filtration rate decreased	12.48	9.47	34	252797	22668	79468889
Tuberculosis gastrointestinal	12.45	9.47	12	252819	562	79490995
Vaginal infection	12.43	9.47	44	252787	5836	79485721
Superinfection	12.42	9.47	39	252792	4863	79486694
Aborted pregnancy	12.42	9.47	5	252826	45	79491512
Inflammation	12.38	9.47	387	252444	93366	79398191
Antithrombin III	12.37	9.47	6	252825	87	79491470
Breast cancer stage I	12.37	9.47	3	252828	6697	79484860
Product label confusion	12.27	9.47	20	252811	1606	79489951
Hypertensive crisis	12.27	9.47	30	252801	20740	79470817
B-lymphocyte count increased	12.26	9.47	7	252824	144	79491413
Thyroxine free decreased	12.25	9.47	16	252815	1051	79490506
Cryptitis	12.23	9.47	9	252822	289	79491268
Hypoaldosteronism	12.23	9.47	10	252821	376	79491181
Meningitis tuberculous	12.20	9.47	17	252814	1188	79490369
Plasma cell myeloma	12.16	9.47	109	252722	53150	79438407
Eye haemorrhage	12.12	9.47	8	252823	9749	79481808
Eosinophilic oesophagitis	12.11	9.47	12	252819	582	79490975
Optic nerve operation	12.09	9.47	11	252820	479	79491078
Angioedema	12.05	9.47	169	252662	75866	79415691
Renal injury	12.05	9.47	22	252809	16905	79474652
Microvillous inclusion disease	12.05	9.47	8	252823	217	79491340
Lymphocyte count decreased	12.05	9.47	94	252737	47195	79444362
Diplegia	12.04	9.47	21	252810	1782	79489775
Pituitary tumour	12.02	9.47	17	252814	1205	79490352
Tessellated fundus	11.95	9.47	5	252826	50	79491507
Hepatocellular injury	11.94	9.47	95	252736	47498	79444059
Embolism venous	11.94	9.47	35	252796	4204	79487353
Gastric ulcer	11.94	9.47	61	252770	33844	79457713
Probiotic therapy	11.88	9.47	7	252824	153	79491404
Abscess	11.82	9.47	118	252713	22833	79468724
Rib fracture	11.81	9.47	47	252784	27900	79463657
Jaundice cholestatic	11.80	9.47	11	252820	11273	79480284
Dry mouth	11.80	9.47	364	252467	87655	79403902
Scrotal infection	11.79	9.47	12	252819	601	79490956
Optic glioma	11.78	9.47	5	252826	52	79491505
Disseminated cryptococcosis	11.78	9.47	21	252810	1813	79489744
Gastric cancer	11.78	9.47	9	252822	10170	79481387
Metastases to lung	11.73	9.47	25	252806	18138	79473419
Enterocolonic fistula	11.72	9.47	7	252824	157	79491400
Nephropathy toxic	11.67	9.47	30	252801	20389	79471168
Vaginal abscess	11.66	9.47	10	252821	402	79491155
Uterine cyst	11.66	9.47	9	252822	311	79491246
Bronchopulmonary aspergillosis	11.66	9.47	115	252716	22179	79469378
Injection site bruising	11.66	9.47	79	252752	40923	79450634
Constipation	11.65	9.47	757	252074	282293	79209264
Anorectal ulcer	11.62	9.47	5	252826	54	79491503
Non-consummation	11.62	9.47	5	252826	54	79491503
Vulvovaginal candidiasis	11.55	9.47	25	252806	2489	79489068
Cushing's syndrome	11.54	9.47	15	252816	980	79490577
Intestinal resection	11.54	9.47	32	252799	3725	79487832
Synovial cyst	11.52	9.47	9	252822	10056	79481501
Sinus node dysfunction	11.49	9.47	5	252826	7696	79483861
Product monitoring error	11.48	9.47	7	252824	8899	79482658
Idiopathic intracranial hypertension	11.48	9.47	29	252802	3193	79488364
Dysgeusia	11.37	9.47	121	252710	57056	79434501
Viral parotitis	11.34	9.47	3	252828	5	79491552
Mental status changes	11.27	9.47	147	252684	66812	79424745
Growth hormone deficiency	11.27	9.47	10	252821	421	79491136
Disorientation	11.25	9.47	136	252695	62640	79428917
Hepatitis acute	11.24	9.47	20	252811	15522	79476035
Pancreatic carcinoma	11.21	9.47	16	252815	13561	79477996
Hypertriglyceridaemia	11.20	9.47	74	252757	12666	79478891
Chorioretinopathy	11.19	9.47	23	252808	2208	79489349
Cryptococcal fungaemia	11.15	9.47	7	252824	172	79491385
Basal cell carcinoma	11.14	9.47	71	252760	37304	79454253
Respiratory rate increased	11.09	9.47	111	252720	21489	79470068
Glucocorticoid deficiency	11.08	9.47	12	252819	646	79490911
Sputum increased	11.05	9.47	36	252795	4577	79486980
Coordination abnormal	11.04	9.47	24	252807	17288	79474269
Hypocalcaemia	11.04	9.47	103	252728	49821	79441736
Cryptococcal meningoencephalitis	11.01	9.47	8	252823	252	79491305
Psychomotor retardation	10.98	9.47	3	252828	6181	79485376
Drug tolerance	10.93	9.47	7	252824	8668	79482889
Posturing	10.88	9.47	15	252816	1038	79490519
Electrocardiogram abnormal	10.84	9.47	23	252808	16714	79474843
Death neonatal	10.83	9.47	12	252819	663	79490894
Full blood count decreased	10.77	9.47	46	252785	26773	79464784
Adenoidal hypertrophy	10.71	9.47	7	252824	185	79491372
Seronegative arthritis	10.69	9.47	36	252795	4656	79486901
Perineal infection	10.69	9.47	13	252818	794	79490763
COVID-19 pneumonia	10.68	9.47	51	252780	28798	79462759
Hyperuricaemia	10.67	9.47	13	252818	11786	79479771
Eosinophil count increased	10.67	9.47	24	252807	17081	79474476
Joint effusion	10.66	9.47	26	252805	17988	79473569
Therapeutic product effect incomplete	10.65	9.47	355	252476	141290	79350267
Lymphocytic hypophysitis	10.64	9.47	11	252820	561	79490996
Rectal abscess	10.63	9.47	22	252809	2123	79489434
Coronary arterial stent insertion	10.60	9.47	3	252828	6041	79485516
Mucosal hyperaemia	10.60	9.47	5	252826	68	79491489
Intestinal stenosis	10.58	9.47	31	252800	3723	79487834
Torsade de pointes	10.56	9.47	29	252802	19283	79472274
Hypoxia	10.51	9.47	248	252583	102995	79388562
Protein urine present	10.41	9.47	10	252821	10102	79481455
Hepatocellular carcinoma	10.41	9.47	8	252823	9013	79482544
Uveitis	10.41	9.47	90	252741	16740	79474817
Hallucination, visual	10.36	9.47	61	252770	32668	79458889
Anorectal discomfort	10.35	9.47	30	252801	3581	79487976
Faecal calprotectin abnormal	10.32	9.47	7	252824	197	79491360
Renal salt-wasting syndrome	10.25	9.47	12	252819	704	79490853
Paradoxical drug reaction	10.20	9.47	5	252826	7180	79484377
Nodule	10.15	9.47	38	252793	22956	79468601
Clostridium difficile infection	10.15	9.47	191	252640	42494	79449063
Sexual dysfunction	10.14	9.47	6	252825	7757	79483800
Infant irritability	10.14	9.47	3	252828	9	79491548
Basilar artery aneurysm	10.13	9.47	4	252827	34	79491523
Normochromic normocytic anaemia	10.06	9.47	6	252825	7721	79483836
Vaginal flatulence	10.04	9.47	24	252807	2551	79489006
Gonadotrophin deficiency	10.03	9.47	4	252827	35	79491522
Rash erythematous	10.03	9.47	247	252584	57522	79434035
Thyrotoxic crisis	9.97	9.47	16	252815	1268	79490289
Pulmonary alveolar haemorrhage	9.97	9.47	13	252818	11444	79480113
Sitting disability	9.96	9.47	9	252822	388	79491169
Oesophageal adenocarcinoma recurrent	9.93	9.47	4	252827	36	79491521
Manipulation	9.93	9.47	5	252826	79	79491478
Multiple-drug resistance	9.93	9.47	8	252823	8800	79482757
Nail disorder	9.91	9.47	68	252763	11784	79479773
Hepatitis C	9.90	9.47	14	252817	11911	79479646
Hyperamylasaemia	9.89	9.47	15	252816	1132	79490425
Cataract	9.87	9.47	138	252693	61982	79429575
Thyroglossal cyst infection	9.84	9.47	4	252827	37	79491520
Visual pathway disorder	9.82	9.47	5	252826	81	79491476
Gram stain positive	9.80	9.47	6	252825	141	79491416
Deafness	9.79	9.47	34	252797	21003	79470554
Aphthous ulcer	9.77	9.47	89	252742	16800	79474757
Catheterisation cardiac	9.76	9.47	3	252828	5725	79485832
Urosepsis	9.71	9.47	47	252784	26448	79465109
Myelitis transverse	9.68	9.47	20	252811	1927	79489630
Hypoperfusion	9.66	9.47	24	252807	2615	79488942
Herpes simplex	9.65	9.47	69	252762	12118	79479439
Shock haemorrhagic	9.62	9.47	32	252799	20028	79471529
Neutrophilic panniculitis	9.60	9.47	5	252826	85	79491472
Status asthmaticus	9.60	9.47	14	252817	1020	79490537
Acute hepatic failure	9.60	9.47	56	252775	30057	79461500
Infusion site streaking	9.55	9.47	10	252821	518	79491039
Ischaemia	9.53	9.47	7	252824	8068	79483489
Gestational diabetes	9.52	9.47	4	252827	6289	79485268
End stage renal disease	9.51	9.47	15	252816	12205	79479352
Arteriosclerosis	9.50	9.47	28	252803	18199	79473358
Pituitary-dependent Cushing's syndrome	9.48	9.47	3	252828	12	79491545
Skin injury	9.48	9.47	28	252803	3378	79488179

FDA Adverse Event Reporting System (Pediatric)

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
Drug-induced liver injury	56.37	37.89	16	205	58	89513
Aspergillus infection	56.06	37.89	17	204	82	89489
Product use issue	41.47	37.89	16	205	175	89396
Hepatotoxicity	41.10	37.89	14	207	103	89468

Pharmacologic Action:

Source	Code	Description
ATC	A01AC03	ALIMENTARY TRACT AND METABOLISM STOMATOLOGICAL PREPARATIONS STOMATOLOGICAL PREPARATIONS Corticosteroids for local oral treatment
ATC	A07EA02	ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS INTESTINAL ANTIINFLAMMATORY AGENTS Corticosteroids acting locally
ATC	C05AA01	CARDIOVASCULAR SYSTEM VASOPROTECTIVES AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE Corticosteroids
ATC	D07AA02	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, weak (group I)
ATC	D07BA04	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTISEPTICS Corticosteroids, weak, combinations with antiseptics
ATC	D07CA01	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS Corticosteroids, weak, combinations with antibiotics
ATC	D07XA01	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, OTHER COMBINATIONS Corticosteroids, weak, other combinations
ATC	H02AB09	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CORTICOSTEROIDS FOR SYSTEMIC USE CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN Glucocorticoids
ATC	R01AD60	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
ATC	S01BA02	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Corticosteroids, plain
ATC	S01BB01	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Corticosteroids and mydriatics in combination
ATC	S01CA03	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION Corticosteroids and antiinfectives in combination
ATC	S01CB03	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION Corticosteroids/antiinfectives/mydriatics in combination
ATC	S02BA01	SENSORY ORGANS OTOLOGICALS CORTICOSTEROIDS Corticosteroids
ATC	S02CA03	SENSORY ORGANS OTOLOGICALS CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION Corticosteroids and antiinfectives in combination
ATC	S03CA04	SENSORY ORGANS OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION Corticosteroids and antiinfectives in combination
FDA MoA	N0000175450	Corticosteroid Hormone Receptor Agonists
FDA EPC	N0000175576	Corticosteroid
MeSH PA	D000893	Anti-Inflammatory Agents
CHEBI has role	CHEBI:35472	anti-inflammatory drugs
CHEBI has role	CHEBI:49167	anti-asthmatic drugs
CHEBI has role	CHEBI:50857	anti-allergic drugs
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
CHEBI has role	CHEBI:88188	allergenic drug

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

Disease	Relation	SNOMED_ID	DOID
Disorder of musculoskeletal system	indication	928000	DOID:17
Cerebral edema	indication	2032001
Otitis externa	indication	3135009
Proctitis	indication	3951002	DOID:3127
Keratitis	indication	5888003	DOID:4677
Tinea pedis	indication	6020002	DOID:12403
Berylliosis	indication	8247009	DOID:10322
Psoriasis	indication	9014002	DOID:8893
Ankylosing spondylitis	indication	9631008	DOID:7147
Cyclitis	indication	17657000
Rheumatic heart disease	indication	23685000
Atopic dermatitis	indication	24079001	DOID:3310
Inflammatory bowel disease	indication	24526004	DOID:0050589
Multiple sclerosis	indication	24700007	DOID:2377
Severe adrenal insufficiency	indication	24867002
Sarcoidosis	indication	31541009	DOID:11335
Idiopathic thrombocytopenic purpura	indication	32273002	DOID:8924
Psoriasis with arthropathy	indication	33339001
Crohn's disease	indication	34000006
Tendinitis	indication	34840004	DOID:971
Erythema multiforme	indication	36715001
Contact dermatitis	indication	40275004	DOID:2773
Angioedema	indication	41291007	DOID:1558
Humoral hypercalcemia of malignancy	indication	47709007
Articular gout	indication	48440001	DOID:13189
Seborrheic dermatitis	indication	50563003	DOID:8741
Edema of larynx	indication	51599000
Chronic ulcerative proctitis	indication	52231000
Nephrotic syndrome	indication	52254009	DOID:1184
Lichen simplex chronicus	indication	53891004
Systemic lupus erythematosus	indication	55464009	DOID:9074
Allergic rhinitis	indication	61582004
Ulcerative colitis	indication	64766004	DOID:8577
Löffler's syndrome	indication	64936001	DOID:9503
Iritis	indication	65074000	DOID:1406
Pemphigus	indication	65172003	DOID:9182
Granuloma annulare	indication	65508009	DOID:3777
Tenosynovitis	indication	67801009	DOID:970
Blepharoconjunctivitis	indication	68659002	DOID:2456
Rheumatoid arthritis	indication	69896004	DOID:7148
Hemorrhoids	indication	70153002	DOID:9746
Transfusion reaction due to serum protein reaction	indication	72284000
Acquired thrombocytopenia	indication	74576004	DOID:11126
Iridocyclitis	indication	77971008
Thyroiditis	indication	82119001	DOID:7166
Bursitis	indication	84017003	DOID:2965
Tinea corporis	indication	84849002
Autoimmune disease	indication	85828009
Corneal abrasion	indication	85848002
Infective otitis externa	indication	86981007	DOID:9463
Infection by larvae of Trichinella spiralis	indication	88264003
Acne vulgaris	indication	88616000
Congenital hypoplastic anemia	indication	88854002	DOID:1339
Pruritus ani	indication	90446007
Corneal ulcer	indication	91514001	DOID:8463
Acute lymphoid leukemia	indication	91857003	DOID:9952
Dermatitis herpetiformis	indication	111196000	DOID:8505
Hodgkin's disease	indication	118599009
Non-Hodgkin's lymphoma	indication	118601006
Mycosis fungoides	indication	118618005
Uveitis	indication	128473001	DOID:13141
Aspiration pneumonitis	indication	155597006
Asthma	indication	195967001	DOID:2841
Discoid lupus erythematosus	indication	200938002
Plaque psoriasis	indication	200965009
Transplanted organ rejection	indication	213148006
Malignant otitis externa due to Pseudomonas aeruginosa	indication	232230009
Congenital adrenal hyperplasia	indication	237751000
Scalp psoriasis	indication	238608008
Punctate keratopathy	indication	246936005
Adrenogenital disorder	indication	267395000	DOID:0050811
Pruritus of genital organs	indication	267802000
Eruption of skin	indication	271807003	DOID:0050486
Infective blepharitis	indication	312219000
Bacterial keratitis	indication	314557000
Disorder of eye	indication	371405004	DOID:5614
Primary adrenocortical insufficiency	indication	373662000
Adrenal cortical hypofunction	indication	386584007	DOID:10493
Herpes zoster keratitis	indication	397573005
Rosacea	indication	398909004	DOID:8881
Tinea cruris	indication	399029005
Erythroderma	indication	399992009
Primary cutaneous T-cell lymphoma	indication	400122007
Recurrent herpes simplex labialis	indication	402892009
Autoimmune hemolytic anemia	indication	413603009	DOID:718
Synovitis	indication	416209007	DOID:2703
Aphthous ulcer of mouth	indication	426965005	DOID:9663
Allergic conjunctivitis	indication	473460002	DOID:11204
Post traumatic osteoarthritis	indication	699262001
Itching of ear	indication	699392007
Inflammatory dermatosis	indication	703938007
Post-Op Ocular Inflammation	indication
Mastoidectomy Cavity Infections	indication
Superficial Ocular Infection	indication
Gingival Disorders	indication
Minor Bacterial Skin Infections	indication
Synovitis due to Osteoarthritis	indication
Diagnostic Test for Cushing's Syndrome	indication
Transfusion Reaction Urticaria	indication
Staphylococcus Aureus Otitis Externa	indication
Systemic Dermatomyositis	indication
Erythroblastic Anemia	indication
Chronic purulent otitis media	off-label use	38394007	DOID:14247
Respiratory distress syndrome in the newborn	off-label use	46775006
Adrenoleukodystrophy	off-label use	65389002	DOID:10588
Pityriasis simplex	off-label use	200767005
Allergic otitis externa	off-label use	405821001
Itching of skin	off-label use	418363000
Otitis Externa Seborrhea	off-label use
Neonatal Bronchopulmonary Dysplasia	off-label use
Congenital Pituitary Hypoplasia	off-label use
Otitis Externa Eczema	off-label use
Mycosis	contraindication	3218000	DOID:1564
Ocular hypertension	contraindication	4210003	DOID:9282
Herpes simplex keratitis	contraindication	9389005
Bacterial septicemia	contraindication	10001005	DOID:0040085
Inactive tuberculosis	contraindication	11999007
Peptic ulcer	contraindication	13200003	DOID:750
Measles	contraindication	14189004	DOID:8622
Esophagitis	contraindication	16761005	DOID:11963
Mood swings	contraindication	18963009
Infection of skin AND/OR subcutaneous tissue	contraindication	19824006
Cirrhosis of liver	contraindication	19943007	DOID:5082
Herpes zoster auricularis	contraindication	21954000	DOID:9210
Glaucoma	contraindication	23986001	DOID:1686
Abscess of intestine	contraindication	24557004
Acute tuberculosis	contraindication	25629007
Shock	contraindication	27942005
Herpes simplex dendritic keratitis	contraindication	29943008
Fungal infection of eye	contraindication	31194008
Bullous myringitis	contraindication	33528003	DOID:13791
Severe myopia	contraindication	34187009
Hyperthyroidism	contraindication	34486009	DOID:7998
Gastrointestinal fistula	contraindication	37831005
Hypertensive disorder	contraindication	38341003	DOID:10763
Infectious disease	contraindication	40733004
Hypothyroidism	contraindication	40930008	DOID:1459
Hypokalemia	contraindication	43339004
Chronic heart failure	contraindication	48447003
Tuberculosis of eye	contraindication	49107007
Duodenal ulcer disease	contraindication	51868009	DOID:1724
Perforation of tympanic membrane	contraindication	60442001
Osteoporosis	contraindication	64859006	DOID:11476
Psychotic disorder	contraindication	69322001
Diabetes mellitus	contraindication	73211009	DOID:9351
Hypopituitarism	contraindication	74728003	DOID:9406
Third degree burn injury	contraindication	80247002
Hyperglycemia	contraindication	80394007	DOID:4195
Decreased respiratory function	contraindication	80954004
Open-angle glaucoma	contraindication	84494001	DOID:1067
Krukenberg spindle	contraindication	85430004
Herpes simplex	contraindication	88594005	DOID:8566
Kidney disease	contraindication	90708001	DOID:557
Disorder of mucous membrane	contraindication	95351003
Bilateral cataracts	contraindication	95722004
Open wound	contraindication	125643001
Eye infection	contraindication	128351009
Seizure disorder	contraindication	128613002
Bacterial infection of eye	contraindication	128984004
Disorder of muscle	contraindication	129565002	DOID:423
Tuberculosis of ear	contraindication	186269001
Ophthalmic herpes simplex	contraindication	186542001
Heart block	contraindication	233916004
Anastomosis of intestine	contraindication	235407009
Disease of liver	contraindication	235856003	DOID:409
Condyloma acuminatum	contraindication	240542006	DOID:11168
Telangiectasia disorder	contraindication	247479008
Diverticulitis of gastrointestinal tract	contraindication	271366000
Injury of eye region	contraindication	282752000
Varicella-zoster virus infection	contraindication	309465005
Viral eye infection	contraindication	312132001
Viral ear infection	contraindication	312137007
Fungal ear infection	contraindication	312148000
Infective otitis media	contraindication	312218008
Skin irritation	contraindication	367466007
Vaccinia keratitis	contraindication	397552005
Gastric ulcer	contraindication	397825006	DOID:10808
Atrophoderma	contraindication	399979006
Peripheral vascular disease	contraindication	400047006
Blister	contraindication	417237009
Denuded skin	contraindication	418242004
Exposure to varicella	contraindication	444453009

🐶 Veterinary Drug Use

Species	Use	Relation
Cats	Acute otitis externa	Indication
Cats	Chronic otitis externa	Indication
Cats	Ear canker	Indication
Cats	Inflammatory conditions of the external ear canal	Indication
Cats	Allergy	Indication
Cats	Infectious skin conditions	Indication
Cats	Traumatic skin conditions	Indication
Cats	Prevention of bacterial infections in superficial wounds	Indication
Cats	Prevention of bacterial infections in cuts	Indication
Cats	Prevention of bacterial infections in abrasions	Indication
Cats	Allergic dermatoses	Indication
Cats	Infections associated with minor burns and wounds	Indication
Cats	Nonspecific pruritus	Indication
Dogs	Acute otitis externa	Indication
Dogs	Chronic otitis externa	Indication
Dogs	Ear canker	Indication
Dogs	Inflammatory conditions of the external ear canal	Indication
Dogs	Allergy	Indication
Dogs	Infectious skin conditions	Indication
Dogs	Traumatic skin conditions	Indication
Dogs	Prevention of bacterial infections in superficial wounds	Indication
Dogs	Prevention of bacterial infections in cuts	Indication
Dogs	Prevention of bacterial infections in abrasions	Indication
Dogs	Allergic dermatoses	Indication
Dogs	Infections associated with minor burns and wounds	Indication
Dogs	Nonspecific pruritus	Indication
Horses	No Use Class Stated Or Implied	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Liqua-Cortril Spray, Terra-Cortril Spray	Zoetis Inc.	2
Cortisporin Veterinary Ophthalmic Ointment	Intervet Inc.	4

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.31	acidic
pKa2	13.65	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
0.5MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9717740	Nov. 19, 2032	TREATMENT OF ADRENAL INSUFFICIENCY
1MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9717740	Nov. 19, 2032	TREATMENT OF ADRENAL INSUFFICIENCY
2MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9717740	Nov. 19, 2032	TREATMENT OF ADRENAL INSUFFICIENCY
5MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9717740	Nov. 19, 2032	TREATMENT OF ADRENAL INSUFFICIENCY
0.5MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9675559	Jan. 10, 2033	TREATMENT OF ADRENAL INSUFFICIENCY
1MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9675559	Jan. 10, 2033	TREATMENT OF ADRENAL INSUFFICIENCY
2MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9675559	Jan. 10, 2033	TREATMENT OF ADRENAL INSUFFICIENCY
5MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9675559	Jan. 10, 2033	TREATMENT OF ADRENAL INSUFFICIENCY
0.5MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9649280	May 12, 2034	TREATMENT OF ADRENAL INSUFFICIENCY
1MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9649280	May 12, 2034	TREATMENT OF ADRENAL INSUFFICIENCY
2MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9649280	May 12, 2034	TREATMENT OF ADRENAL INSUFFICIENCY
5MG	ALKINDI SPRINKLE	ETON	N213876	Sept. 29, 2020	RX	GRANULE	ORAL	9649280	May 12, 2034	TREATMENT OF ADRENAL INSUFFICIENCY

Orange Book exclusivity data (new drug applications)

None

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	8.50	WOMBAT-PK	CHEMBL
Annexin A1	Cytosolic other	P04083	ANXA1_HUMAN				WOMBAT-PK
Mineralocorticoid receptor	Nuclear hormone receptor	P08235	MCR_HUMAN	AGONIST	IC50	9.95	IUPHAR
Nitric oxide synthase, inducible	Enzyme	P35228	NOS2_HUMAN		IC50	8	WOMBAT-PK
Corticosteroid-binding globulin	Secreted	P08185	CBG_HUMAN		Ki	7.88	WOMBAT-PK
Sex hormone-binding globulin	Secreted	P04278	SHBG_HUMAN		Kd	6.20	CHEMBL
Glucocorticoid receptor	Transcription factor		GCR_RAT		IC50	7.60	CHEMBL
Glucocorticoid receptor	Transcription factor		GCR_MOUSE		Kd	7.37	CHEMBL

External reference:

ID	Source
4017941	VUID
N0000146291	NUI
D00088	KEGG_DRUG
4017941	VANDF
C0020268	UMLSCUI
CHEBI:17650	CHEBI
HCY	PDB_CHEM_ID
CHEMBL389621	ChEMBL_ID
DB00741	DRUGBANK_ID
D006854	MESH_DESCRIPTOR_UI
5754	PUBCHEM_CID
38	INN_ID
WI4X0X7BPJ	UNII
202643	RXNORM
174	MMSL
2500	MMSL
4837	MMSL
d00254	MMSL
002147	NDDF
16602005	SNOMEDCT_US
396458002	SNOMEDCT_US
2868	IUPHAR_LIGAND_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
CORTEF	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0012	TABLET	5 mg	ORAL	NDA	15 sections
CORTEF	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0012	TABLET	5 mg	ORAL	NDA	15 sections
CORTEF	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0031	TABLET	10 mg	ORAL	NDA	15 sections
CORTEF	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0031	TABLET	10 mg	ORAL	NDA	15 sections
CORTEF	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0044	TABLET	20 mg	ORAL	NDA	15 sections
CORTEF	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0044	TABLET	20 mg	ORAL	NDA	15 sections
CIPROHC	HUMAN PRESCRIPTION DRUG LABEL	2	0065-8531	SUSPENSION	10 mg	AURICULAR (OTIC)	NDA	16 sections
CIPROHC	HUMAN PRESCRIPTION DRUG LABEL	2	0065-8531	SUSPENSION	10 mg	AURICULAR (OTIC)	NDA	16 sections
CIPROHC	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0855	SUSPENSION/ DROPS	10 mg	AURICULAR (OTIC)	NDA	16 sections
CIPROHC	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0855	SUSPENSION/ DROPS	10 mg	AURICULAR (OTIC)	NDA	16 sections
Aquanil HC	HUMAN OTC DRUG LABEL	1	0096-0732	LOTION	0.01 g	TOPICAL	OTC monograph not final	10 sections
Aquanil HC	HUMAN OTC DRUG LABEL	1	0096-0732	LOTION	0.01 g	TOPICAL	OTC monograph not final	10 sections
Good Sense Anti Itch	HUMAN OTC DRUG LABEL	1	0113-0471	OINTMENT	1 g	TOPICAL	OTC monograph not final	13 sections
good sense anti itch	HUMAN OTC DRUG LABEL	1	0113-0541	CREAM	1 g	TOPICAL	OTC monograph not final	13 sections
basic care hydrocortisone	HUMAN OTC DRUG LABEL	1	0113-0793	CREAM	1 g	TOPICAL	OTC monograph not final	13 sections
Good Sense Anti Itch	HUMAN OTC DRUG LABEL	1	0113-0973	CREAM	1 g	TOPICAL	OTC monograph not final	13 sections
Good Sense Anti Itch	HUMAN OTC DRUG LABEL	1	0113-0973	CREAM	1 g	TOPICAL	OTC monograph not final	13 sections
good sense anti itch	HUMAN OTC DRUG LABEL	1	0113-1369	CREAM	1 g	TOPICAL	OTC monograph not final	13 sections
Basic Case Hydrocortisone Anti-Itch	HUMAN OTC DRUG LABEL	1	0113-7006	CREAM	1 g	TOPICAL	OTC monograph not final	13 sections
basic care hydrocortisone	HUMAN OTC DRUG LABEL	1	0113-7369	CREAM	1 g	TOPICAL	OTC monograph not final	13 sections
HYDROCORTISONE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1696	TABLET	5 mg	ORAL	ANDA	14 sections
HYDROCORTISONE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1696	TABLET	5 mg	ORAL	ANDA	14 sections
HYDROCORTISONE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1697	TABLET	10 mg	ORAL	ANDA	14 sections
HYDROCORTISONE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1697	TABLET	10 mg	ORAL	ANDA	14 sections
HYDROCORTISONE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1700	TABLET	20 mg	ORAL	ANDA	14 sections
HYDROCORTISONE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1700	TABLET	20 mg	ORAL	ANDA	14 sections
HYDROCORTISONE	HUMAN OTC DRUG LABEL	1	0168-0014	CREAM	5 mg	TOPICAL	OTC monograph final	9 sections
hydrocortisone	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0015	CREAM	10 mg	TOPICAL	ANDA	19 sections
HYDROCORTISONE	HUMAN OTC DRUG LABEL	1	0168-0016	OINTMENT	5 mg	TOPICAL	OTC monograph final	9 sections
Hydrocortisone	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0020	OINTMENT	10 mg	TOPICAL	ANDA	18 sections