hydrocortisone 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

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)	0.42 mg/mL	Benet LZ, Broccatelli F, Oprea TI
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	415.67	9.42	1131	141634	154826	53051475
Completed suicide	327.85	9.42	9	142756	138192	53068109
Adrenocortical insufficiency acute	311.27	9.42	126	142639	1387	53204914
Anti-cyclic citrullinated peptide antibody positive	288.25	9.42	535	142230	56637	53149664
Pericarditis	270.42	9.42	558	142207	63848	53142453
Adrenal insufficiency	266.71	9.42	259	142506	14570	53191731
Rheumatoid factor positive	240.38	9.42	411	142354	40787	53165514
Drug hypersensitivity	238.26	9.42	1364	141401	263878	52942423
Wound	229.77	9.42	650	142115	90907	53115394
Discomfort	216.76	9.42	654	142111	94818	53111483
Hand deformity	206.69	9.42	596	142169	84253	53122048
Toxicity to various agents	192.91	9.42	182	142583	219416	52986885
Steroid withdrawal syndrome	176.58	9.42	64	142701	507	53205794
Synovitis	172.39	9.42	657	142108	107236	53099065
Glossodynia	171.32	9.42	624	142141	99667	53106634
Death	168.57	9.42	449	142316	356783	52849518
Duodenal ulcer perforation	152.54	9.42	309	142456	34874	53171427
Pemphigus	145.71	9.42	608	142157	103423	53102878
Intentional product use issue	139.28	9.42	469	142296	72025	53134276
Helicobacter infection	137.12	9.42	315	142450	38754	53167547
Hypersensitivity	132.99	9.42	992	141773	209673	52996628
Drug abuse	131.26	9.42	12	142753	65514	53140787
Systemic lupus erythematosus	129.88	9.42	671	142094	124743	53081558
Arthropathy	127.73	9.42	729	142036	140724	53065577
Hepatic enzyme increased	124.38	9.42	666	142099	125529	53080772
Product use issue	116.73	9.42	705	142060	138879	53067422
Colitis ulcerative	116.14	9.42	205	142560	20856	53185445
Intentional overdose	101.73	9.42	27	142738	67178	53139123
Swelling	99.88	9.42	862	141903	190243	53016058
Febrile bone marrow aplasia	99.32	9.42	109	142656	7080	53199221
Overdose	98.42	9.42	86	142679	107650	53098651
Craniopharyngioma	97.73	9.42	30	142735	131	53206170
Fall	87.93	9.42	580	142185	357860	52848441
Blood pressure fluctuation	86.14	9.42	249	142516	35221	53171080
Drug interaction	80.61	9.42	308	142457	219021	52987280
Hypofibrinogenaemia	80.57	9.42	46	142719	1129	53205172
Abdominal discomfort	79.10	9.42	922	141843	220140	52986161
Drug intolerance	78.00	9.42	867	141898	204626	53001675
Secondary adrenocortical insufficiency	77.38	9.42	46	142719	1220	53205081
Condition aggravated	77.15	9.42	1169	141596	295965	52910336
Alopecia	75.51	9.42	959	141806	233624	52972677
Rash	73.61	9.42	1635	141130	444556	52761745
Pituitary tumour benign	71.18	9.42	51	142714	1870	53204431
Maternal exposure during pregnancy	59.16	9.42	657	142108	154982	53051319
Blister	59.06	9.42	387	142378	78366	53127935
Product dose omission issue	58.24	9.42	289	142476	191331	53014970
Rheumatic fever	56.17	9.42	112	142653	12492	53193809
Suicide attempt	53.63	9.42	46	142719	58122	53148179
Device expulsion	53.40	9.42	8	142757	29805	53176496
Cardiac failure congestive	52.96	9.42	105	142660	92652	53113649
Hip arthroplasty	52.36	9.42	179	142586	27683	53178618
Acute kidney injury	50.65	9.42	435	142330	253433	52952868
Urticaria thermal	46.76	9.42	17	142748	136	53206165
Frequent bowel movements	45.99	9.42	112	142653	14300	53192001
Adrenal suppression	45.96	9.42	30	142735	942	53205359
Cerebrovascular accident	45.89	9.42	137	142628	105037	53101264
Female genital tract fistula	45.09	9.42	55	142710	4003	53202298
Cortisol decreased	44.40	9.42	31	142734	1090	53205211
Hyperadrenocorticism	44.19	9.42	21	142744	348	53205953
Swollen joint count increased	44.06	9.42	95	142670	11195	53195106
Joint swelling	43.81	9.42	876	141889	233762	52972539
Hypopituitarism	41.91	9.42	28	142737	915	53205386
Knee arthroplasty	40.70	9.42	188	142577	33381	53172920
Hypothalamic pituitary adrenal axis suppression	38.41	9.42	15	142750	149	53206152
Musculoskeletal injury	37.87	9.42	14	142751	118	53206183
Heart rate irregular	37.47	9.42	130	142635	20254	53186047
Poor venous access	36.73	9.42	82	142683	9893	53196408
Colitis	36.68	9.42	213	142552	41339	53164962
Cardiac failure	36.60	9.42	113	142652	85731	53120570
Anaemia	36.50	9.42	521	142244	276197	52930104
Hypothalamo-pituitary disorder	35.13	9.42	23	142742	726	53205575
Intentional self-injury	34.92	9.42	12	142753	25272	53181029
Sedation	34.71	9.42	18	142747	29657	53176644
Off label use	34.34	9.42	1568	141197	470644	52735657
Drug level below therapeutic	34.24	9.42	46	142719	3687	53202614
Respiratory arrest	34.11	9.42	24	142741	33516	53172785
Serotonin syndrome	34.01	9.42	14	142751	26392	53179909
Neoplasm recurrence	33.54	9.42	37	142728	2417	53203884
Contraindicated product administered	33.33	9.42	529	142236	135100	53071201
Perioral dermatitis	33.11	9.42	12	142753	95	53206206
Irritable bowel syndrome	33.05	9.42	215	142550	43417	53162884
Nausea	32.69	9.42	1673	141092	754418	52451883
Insulin-like growth factor increased	32.32	9.42	23	142742	834	53205467
Eczema	32	9.42	139	142626	24043	53182258
Muscle injury	31.97	9.42	161	142604	29605	53176696
Coma	31.88	9.42	74	142691	61709	53144592
Renal impairment	31.87	9.42	115	142650	83203	53123098
Syncope	31.69	9.42	173	142592	111820	53094481
Cardio-respiratory arrest	31.43	9.42	69	142696	58689	53147612
Inappropriate schedule of product administration	31.17	9.42	322	142443	74556	53131745
Faecal calprotectin increased	30.94	9.42	33	142732	2075	53204226
Tendonitis	30.86	9.42	108	142657	16898	53189403
Breast cancer	30.71	9.42	53	142712	49305	53156996
Human bocavirus infection	30.65	9.42	16	142749	327	53205974
Interstitial lung disease	30.42	9.42	70	142695	58552	53147749
Sleep disorder due to general medical condition, insomnia type	29.99	9.42	137	142628	24212	53182089
Malignant neoplasm progression	29.91	9.42	95	142670	71446	53134855
Myocardial infarction	29.49	9.42	151	142614	99203	53107098
Chronic obstructive pulmonary disease	29.27	9.42	76	142689	60997	53145304
Injury	28.73	9.42	234	142531	50737	53155564
Type 2 diabetes mellitus	28.38	9.42	163	142602	31507	53174794
Asphyxia	28.19	9.42	54	142711	5847	53200454
Hypophysitis	28.18	9.42	28	142737	1619	53204682
Electrocardiogram QT prolonged	27.95	9.42	69	142696	56334	53149967
Cognitive disorder	27.93	9.42	48	142717	44730	53161571
Blood creatinine increased	27.85	9.42	120	142645	82542	53123759
Salpingo-oophorectomy unilateral	27.75	9.42	19	142746	647	53205654
Folliculitis	27.63	9.42	162	142603	31547	53174754
Insulin-like growth factor decreased	27.30	9.42	16	142749	413	53205888
Drug withdrawal syndrome	27.27	9.42	21	142744	28001	53178300
Therapeutic response shortened	27.20	9.42	59	142706	6980	53199321
Wrong technique in product usage process	27.05	9.42	77	142688	59955	53146346
Haemoglobin decreased	27.02	9.42	236	142529	137071	53069230
Plasma cell myeloma	26.63	9.42	55	142710	47819	53158482
Hospitalisation	26.51	9.42	99	142666	70913	53135388
Body temperature fluctuation	26.33	9.42	30	142735	2031	53204270
Gastrointestinal haemorrhage	26.22	9.42	118	142647	80212	53126089
Atrial fibrillation	26.12	9.42	183	142582	111469	53094832
Lactic acidosis	26.03	9.42	37	142728	37216	53169085
Arthralgia	25.88	9.42	1431	141334	438352	52767949
Drug tolerance decreased	25.44	9.42	59	142706	7299	53199002
Urticaria	24.88	9.42	506	142259	135379	53070922
Natural killer-cell leukaemia	24.47	9.42	10	142755	113	53206188
Tendon pain	24.37	9.42	36	142729	3152	53203149
Adrenal disorder	24.19	9.42	24	142741	1385	53204916
Suicidal ideation	24.16	9.42	82	142683	60429	53145872
Antithrombin III	23.84	9.42	11	142754	170	53206131
Haematochezia	23.62	9.42	194	142571	42164	53164137
Injection site reaction	23.51	9.42	65	142700	51101	53155200
Disease progression	23.38	9.42	168	142597	101752	53104549
Allergy test positive	23.23	9.42	14	142751	381	53205920
Tendon rupture	23.13	9.42	60	142705	7964	53198337
Mucous stools	22.88	9.42	34	142731	2992	53203309
Anal fistula	22.61	9.42	33	142732	2858	53203443
Platelet count decreased	22.52	9.42	183	142582	107916	53098385
Intentional product misuse	22.51	9.42	63	142702	49329	53156972
Faecal volume decreased	22.43	9.42	11	142754	196	53206105
Septic shock	22.39	9.42	260	142505	61969	53144332
Metastases to bone	22.20	9.42	12	142753	19316	53186985
Blood creatine phosphokinase increased	22.08	9.42	27	142738	28958	53177343
Skin weeping	21.86	9.42	13	142752	345	53205956
Normal tension glaucoma	21.58	9.42	8	142757	68	53206233
Blood count abnormal	21.38	9.42	14	142751	20301	53186000
Anal abscess	21.35	9.42	38	142727	3890	53202411
Injection site swelling	21.24	9.42	52	142713	42576	53163725
Airway peak pressure increased	21.22	9.42	12	142753	289	53206012
Proctalgia	21.17	9.42	45	142720	5251	53201050
Bradycardia	21.08	9.42	108	142657	70948	53135353
Product quality issue	21.04	9.42	42	142723	36981	53169320
Pulmonary arterial hypertension	20.94	9.42	25	142740	27097	53179204
Depressed level of consciousness	20.89	9.42	75	142690	54353	53151948
Erythrodermic psoriasis	20.76	9.42	19	142746	991	53205310
Somnolence	20.64	9.42	320	142445	167414	53038887
Diaphragm muscle weakness	20.59	9.42	6	142759	21	53206280
Gastroenteritis norovirus	20.50	9.42	24	142741	1673	53204628
Eczema herpeticum	20.36	9.42	9	142756	125	53206176
Hepatic function abnormal	20.01	9.42	43	142722	36856	53169445
Clostridium difficile colitis	19.90	9.42	105	142660	19660	53186641
Injection site erythema	19.89	9.42	123	142642	77126	53129175
Neuroleptic malignant syndrome	19.86	9.42	4	142761	12029	53194272
Anal fissure	19.84	9.42	32	142733	3024	53203277
Meningitis candida	19.70	9.42	7	142758	52	53206249
Oedema peripheral	19.62	9.42	330	142435	170457	53035844
Fistula	19.38	9.42	60	142705	8810	53197491
Labelled drug-drug interaction medication error	19.35	9.42	3	142762	10896	53195405
Secondary immunodeficiency	19.16	9.42	19	142746	1096	53205205
Perfume sensitivity	18.88	9.42	15	142750	644	53205657
Drug level decreased	18.86	9.42	50	142715	6724	53199577
Loss of consciousness	18.80	9.42	205	142560	114007	53092294
Treatment failure	18.74	9.42	463	142302	127940	53078361
Acute myocardial infarction	18.63	9.42	38	142727	33197	53173104
Blood cholesterol increased	18.45	9.42	220	142545	52769	53153532
Arteriosclerosis coronary artery	18.30	9.42	57	142708	8397	53197904
Accidental exposure to product	18.09	9.42	22	142743	23652	53182649
Pituitary tumour recurrent	17.71	9.42	7	142758	72	53206229
Therapy cessation	17.52	9.42	30	142735	27995	53178306
Febrile neutropenia	17.34	9.42	385	142380	104551	53101750
Wheezing	17.33	9.42	258	142507	65017	53141284
Enterococcal sepsis	17.32	9.42	20	142745	1374	53204927
Abdominal pain	17.30	9.42	844	141921	255059	52951242
Cerebral microangiopathy	17.28	9.42	10	142755	252	53206049
Sinusitis fungal	17.27	9.42	20	142745	1378	53204923
Rhabdomyolysis	17.21	9.42	60	142705	43863	53162438
B-lymphocyte count increased	17.20	9.42	8	142757	126	53206175
Natural killer cell count decreased	17.07	9.42	6	142759	43	53206258
Leukoencephalopathy	17.01	9.42	36	142729	4188	53202113
Vaginal flatulence	16.96	9.42	10	142755	261	53206040
White blood cell count decreased	16.86	9.42	233	142532	124242	53082059
Excessive eye blinking	16.72	9.42	16	142749	883	53205418
Diabetes insipidus	16.64	9.42	27	142738	2564	53203737
Skin fragility	16.64	9.42	14	142751	652	53205649
Melaena	16.59	9.42	33	142732	29096	53177205
Vaginal discharge	16.57	9.42	43	142722	5710	53200591
Tuberculosis gastrointestinal	16.50	9.42	11	142754	358	53205943
Neutropenic infection	16.40	9.42	18	142747	1169	53205132
Dry skin	16.38	9.42	191	142574	45569	53160732
Mastocytosis	16.35	9.42	12	142753	457	53205844
Lupus vulgaris	16.30	9.42	13	142752	561	53205740
Cardiac arrest	16.27	9.42	166	142599	93501	53112800
Neutropenia	16.26	9.42	314	142451	158871	53047430
Balance disorder	16.14	9.42	122	142643	73085	53133216
Abortion spontaneous	16.14	9.42	67	142698	46568	53159733
Diarrhoea haemorrhagic	16.11	9.42	54	142711	8266	53198035
Tendon disorder	16.10	9.42	42	142723	5593	53200708
Drug level above therapeutic	16.09	9.42	34	142731	3950	53202351
Drug specific antibody present	15.99	9.42	31	142734	3387	53202914
Live birth	15.85	9.42	81	142684	14978	53191323
Weight increased	15.84	9.42	684	142081	203883	53002418
Schizophrenia	15.80	9.42	4	142761	10275	53196026
Tremor	15.76	9.42	239	142526	125497	53080804
Hypogonadism	15.73	9.42	7	142758	99	53206202
Femur fracture	15.56	9.42	54	142711	39531	53166770
Cardiac disorder	15.32	9.42	69	142696	46897	53159404
Sputum increased	15.24	9.42	24	142741	2222	53204079
Macular degeneration	15.21	9.42	7	142758	12354	53193947
Injection site pain	15.09	9.42	213	142552	113178	53093123
Pneumonia	15.09	9.42	914	141851	406255	52800046
Red blood cell sedimentation rate abnormal	14.96	9.42	12	142753	15677	53190624
Glomerulonephritis chronic	14.80	9.42	8	142757	176	53206125
CSF lymphocyte count abnormal	14.78	9.42	3	142762	0	53206301
Thyroid stimulating immunoglobulin increased	14.73	9.42	7	142758	116	53206185
Complication associated with device	14.63	9.42	13	142752	16152	53190149
Rhinovirus infection	14.49	9.42	32	142733	3833	53202468
Pyoderma gangrenosum	14.36	9.42	28	142737	3071	53203230
Accidental overdose	14.36	9.42	22	142743	21457	53184844
Orthostatic hypotension	14.27	9.42	37	142728	29716	53176585
Unevaluable event	14.25	9.42	76	142689	49422	53156879
Dyskinesia	14.21	9.42	41	142724	31792	53174509
Pseudostroke	14.19	9.42	4	142761	12	53206289
Deep vein thrombosis postoperative	14.12	9.42	16	142749	1077	53205224
Product prescribing error	14.08	9.42	25	142740	23006	53183295
Fibromyalgia	14.05	9.42	180	142585	43895	53162406
Medication error	14.03	9.42	50	142715	36315	53169986
Rectal abscess	13.98	9.42	16	142749	1088	53205213
Nasal polyps	13.93	9.42	27	142738	2949	53203352
Hepatotoxicity	13.89	9.42	34	142731	27846	53178455
Ascites	13.80	9.42	57	142708	39678	53166623
Excessive skin	13.78	9.42	7	142758	135	53206166
Cerebral vasoconstriction	13.76	9.42	16	142749	1107	53205194
Osteonecrosis of jaw	13.74	9.42	50	142715	36096	53170205
PO2 decreased	13.71	9.42	19	142746	1568	53204733
Candida infection	13.69	9.42	115	142650	25158	53181143
Increased bronchial secretion	13.61	9.42	20	142745	1743	53204558
Dysarthria	13.59	9.42	59	142706	40509	53165792
Vertigo	13.56	9.42	91	142674	55990	53150311
Hyperemesis gravidarum	13.54	9.42	12	142753	600	53205701
Neutropenic sepsis	13.52	9.42	76	142689	14573	53191728
Hepatic cirrhosis	13.51	9.42	17	142748	18005	53188296
Hepatitis	13.48	9.42	46	142719	33848	53172453
Therapeutic product effect incomplete	13.45	9.42	169	142596	91615	53114686
Pituitary haemorrhage	13.28	9.42	6	142759	88	53206213
Aborted pregnancy	13.24	9.42	5	142760	45	53206256
Dry eye	13.15	9.42	46	142719	33598	53172703
Breast cancer metastatic	13.08	9.42	13	142752	15315	53190986
Aspergillus infection	13.08	9.42	47	142718	7449	53198852
X-ray abnormal	13.00	9.42	23	142742	2343	53203958
Therapeutic reaction time decreased	12.97	9.42	17	142748	1330	53204971
Shared psychotic disorder	12.93	9.42	4	142761	18	53206283
Hypercapnia	12.89	9.42	36	142729	4991	53201310
Erythema	12.85	9.42	528	142237	156441	53049860
Agitation	12.78	9.42	98	142667	58528	53147773
Hypertensive crisis	12.73	9.42	12	142753	14494	53191807
Palmar-plantar erythrodysaesthesia syndrome	12.72	9.42	24	142741	21582	53184719
Ear canal erythema	12.71	9.42	3	142762	3	53206298
Astrocytoma	12.70	9.42	6	142759	98	53206203
Secondary hypogonadism	12.65	9.42	6	142759	99	53206202
Skin atrophy	12.64	9.42	34	142731	4612	53201689
Blood growth hormone increased	12.61	9.42	10	142755	428	53205873
Embolism venous	12.59	9.42	26	142739	2973	53203328
Suffocation feeling	12.58	9.42	17	142748	1370	53204931
Transient ischaemic attack	12.56	9.42	51	142714	35674	53170627
Device difficult to use	12.54	9.42	6	142759	10353	53195948
PCO2 increased	12.46	9.42	16	142749	1227	53205074
Herpes simplex hepatitis	12.44	9.42	9	142756	335	53205966
Coronary artery dissection	12.40	9.42	13	142752	801	53205500
Pneumatosis	12.37	9.42	10	142755	440	53205861
Autoimmune nephritis	12.37	9.42	9	142756	338	53205963
Glucocorticoid deficiency	12.35	9.42	8	142757	248	53206053
Pseudomonas infection	12.34	9.42	58	142707	10370	53195931
Renal failure	12.29	9.42	233	142532	118219	53088082
Status asthmaticus	12.28	9.42	14	142751	948	53205353
Lung hyperinflation	12.25	9.42	16	142749	1248	53205053
Coronary artery disease	12.22	9.42	47	142718	33390	53172911
Blood corticotrophin decreased	11.96	9.42	8	142757	262	53206039
Geotrichum infection	11.95	9.42	10	142755	462	53205839
Prescription drug used without a prescription	11.94	9.42	19	142746	1775	53204526
Nasopharyngitis	11.91	9.42	629	142136	191666	53014635
Skin injury	11.89	9.42	18	142747	1610	53204691
Dizziness	11.85	9.42	847	141918	371412	52834889
International normalised ratio increased	11.80	9.42	77	142688	47684	53158617
Cerebrospinal fluid leakage	11.78	9.42	14	142751	992	53205309
Eosinophilic oesophagitis	11.57	9.42	8	142757	277	53206024
Vulvovaginal pain	11.52	9.42	22	142743	2377	53203924
Crohn's disease	11.50	9.42	42	142723	6708	53199593
No adverse event	11.46	9.42	60	142705	39205	53167096
Anorectal ulcer	11.41	9.42	5	142760	68	53206233
Heart rate decreased	11.40	9.42	150	142615	36797	53169504
Toxic skin eruption	11.38	9.42	11	142754	13128	53193173
Fluid retention	11.37	9.42	92	142673	54309	53151992
Product storage error	11.36	9.42	11	142754	13119	53193182
Foetal exposure during pregnancy	11.32	9.42	51	142714	34664	53171637
Therapeutic product effect decreased	11.30	9.42	427	142338	125228	53081073
Pneumatosis intestinalis	11.28	9.42	21	142744	2225	53204076
Staphylococcal infection	11.28	9.42	155	142610	38393	53167908
Parkinsonism	11.25	9.42	5	142760	9008	53197293
Non-consummation	11.21	9.42	5	142760	71	53206230
Sensitivity to weather change	11.21	9.42	39	142726	6083	53200218
Extrapyramidal disorder	11.19	9.42	10	142755	12392	53193909
Abnormal faeces	11.17	9.42	32	142733	4502	53201799
Dystonia	11.16	9.42	11	142754	13010	53193291
Thyrotoxic crisis	11	9.42	12	142753	774	53205527
Blood triglycerides decreased	10.97	9.42	5	142760	75	53206226
Ankle fracture	10.96	9.42	17	142748	16498	53189803
Lower respiratory tract infection	10.96	9.42	320	142445	90661	53115640
Intestinal stenosis	10.85	9.42	23	142742	2678	53203623
Bronchopulmonary aspergillosis	10.85	9.42	49	142716	8616	53197685
Myelosuppression	10.81	9.42	11	142754	12817	53193484
Pituitary infarction	10.79	9.42	4	142761	34	53206267
Enteritis	10.78	9.42	44	142721	7402	53198899
Feeding intolerance	10.77	9.42	10	142755	531	53205770
Aspartate aminotransferase increased	10.77	9.42	159	142606	83870	53122431
Respiratory depression	10.77	9.42	11	142754	12795	53193506
Seizure	10.75	9.42	264	142501	129245	53077056
Decreased appetite	10.73	9.42	468	142297	214506	52991795
Drug eruption	10.71	9.42	33	142732	25061	53181240
Muscle rigidity	10.71	9.42	8	142757	10833	53195468
Brachycephaly	10.69	9.42	4	142761	35	53206266
Myoclonus	10.68	9.42	16	142749	15748	53190553
Bacterial infection	10.68	9.42	82	142683	17465	53188836
Oesophageal adenocarcinoma recurrent	10.59	9.42	4	142761	36	53206265
Gastrointestinal scarring	10.58	9.42	7	142758	225	53206076
Pain	10.52	9.42	1759	141006	586639	52619662
Wound secretion	10.50	9.42	30	142735	4213	53202088
Ileectomy	10.48	9.42	6	142759	148	53206153
Kidney infection	10.45	9.42	87	142678	18980	53187321
Reaction to preservatives	10.44	9.42	7	142758	230	53206071
Encephalitis autoimmune	10.44	9.42	15	142750	1281	53205020
Adjustment disorder with depressed mood	10.40	9.42	22	142743	2558	53203743
Thrombocytopenia	10.40	9.42	287	142478	138440	53067861
Visual pathway disorder	10.40	9.42	4	142761	38	53206263
Tuberous sclerosis complex	10.35	9.42	5	142760	86	53206215
Uterine cyst	10.34	9.42	9	142756	439	53205862
Akathisia	10.32	9.42	5	142760	8566	53197735
Depression	10.31	9.42	393	142372	182659	53023642
Arrhythmia	10.29	9.42	57	142708	36722	53169579
Osteopenia	10.28	9.42	21	142744	18334	53187967
Respiratory acidosis	10.26	9.42	39	142726	6349	53199952
Proctitis	10.26	9.42	19	142746	2006	53204295
Faecal calprotectin abnormal	10.22	9.42	4	142761	40	53206261
Anti-thyroid antibody positive	10.12	9.42	9	142756	452	53205849
Thyroxine free increased	10.07	9.42	12	142753	852	53205449
Pruritus	10.06	9.42	915	141850	292917	52913384
Colonic abscess	10.01	9.42	12	142753	858	53205443
Blood gonadotrophin decreased	9.98	9.42	3	142762	12	53206289
Mobility decreased	9.95	9.42	271	142494	76000	53130301
Blood smear test abnormal	9.86	9.42	5	142760	96	53206205
Pulmonary hypertension	9.77	9.42	59	142706	37211	53169090
Maternal exposure timing unspecified	9.76	9.42	24	142741	3082	53203219
Skin wrinkling	9.74	9.42	13	142752	1035	53205266
Dislocation of vertebra	9.69	9.42	22	142743	2684	53203617
Pneumonia aspiration	9.69	9.42	53	142712	34248	53172053
Vaccination site inflammation	9.65	9.42	4	142761	47	53206254
Aplastic anaemia	9.64	9.42	46	142719	8275	53198026
Pleural effusion	9.57	9.42	173	142592	88406	53117895
Oropharyngeal pain	9.56	9.42	285	142480	80983	53125318
Hallucination	9.52	9.42	95	142670	53743	53152558
Pneumopericardium	9.50	9.42	4	142761	49	53206252
Therapy interrupted	9.45	9.42	24	142741	19412	53186889
Drug resistance	9.44	9.42	25	142740	19937	53186364
Blood corticotrophin increased	9.43	9.42	4	142761	50	53206251
Neutrophilic panniculitis	9.43	9.42	4	142761	50	53206251

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
Adrenal insufficiency	236.27	9.74	208	76304	11760	32425254
Infusion related reaction	170.30	9.74	349	76163	45250	32391764
Blood pressure fluctuation	169.99	9.74	223	76289	19912	32417102
Craniopharyngioma	169.19	9.74	51	76461	242	32436772
Completed suicide	160.21	9.74	16	76496	92501	32344513
Toxicity to various agents	155.90	9.74	115	76397	177926	32259088
Death	153.94	9.74	430	76082	382087	32054927
Drug abuse	149.66	9.74	10	76502	80233	32356781
Adrenocortical insufficiency acute	147.07	9.74	70	76442	1334	32435680
Graft loss	138.94	9.74	59	76453	849	32436165
Colitis ulcerative	121.51	9.74	174	76338	16877	32420137
Serum sickness	118.77	9.74	67	76445	1836	32435178
Febrile bone marrow aplasia	114.27	9.74	119	76393	8296	32428718
Off label use	111.12	9.74	1154	75358	305166	32131848
Hypofibrinogenaemia	95.31	9.74	56	76456	1660	32435354
Frequent bowel movements	94.59	9.74	114	76398	9338	32427676
Intentional product use issue	91.61	9.74	262	76250	41949	32395065
Febrile neutropenia	84.85	9.74	526	75986	119040	32317974
Product use issue	82.01	9.74	292	76220	52485	32384529
Hypopituitarism	76.00	9.74	50	76462	1817	32435197
Diabetes insipidus	75.72	9.74	57	76455	2575	32434439
Leukoencephalopathy	74.10	9.74	68	76444	4057	32432957
Drug interaction	69.65	9.74	271	76241	217914	32219100
Heart rate irregular	68.92	9.74	121	76391	13957	32423057
Intentional overdose	65.13	9.74	10	76502	41591	32395423
Inappropriate schedule of product administration	58.36	9.74	238	76274	45587	32391427
Drug specific antibody present	54.93	9.74	46	76466	2427	32434587
Adrenal suppression	54.17	9.74	29	76483	715	32436299
Condition aggravated	54.08	9.74	582	75930	155079	32281935
Pituitary tumour benign	53.64	9.74	30	76482	808	32436206
Interstitial lung disease	51.77	9.74	46	76466	64955	32372059
Insulin-like growth factor decreased	50.36	9.74	20	76492	240	32436774
Steroid withdrawal syndrome	49.31	9.74	19	76493	209	32436805
Impaired quality of life	48.54	9.74	42	76470	2318	32434696
Tendon pain	48.22	9.74	45	76467	2743	32434271
Septic shock	47.30	9.74	301	76211	68688	32368326
Mucosal inflammation	46.89	9.74	179	76333	33255	32403759
Arthralgia	46.09	9.74	543	75969	147905	32289109
Pseudostroke	44.10	9.74	12	76500	36	32436978
Tendon disorder	42.61	9.74	41	76471	2597	32434417
Body temperature fluctuation	42.19	9.74	32	76480	1462	32435552
Overdose	41.78	9.74	89	76423	86988	32350026
Hypertriglyceridaemia	40.19	9.74	73	76439	8646	32428368
Tendon rupture	40.01	9.74	66	76446	7237	32429777
Suicide attempt	39.95	9.74	20	76492	38224	32398790
Heart rate decreased	39.61	9.74	140	76372	25060	32411954
Myocardial infarction	38.82	9.74	158	76354	125518	32311496
Renal impairment	37.78	9.74	102	76410	91870	32345144
Fistula	37.69	9.74	55	76457	5424	32431590
Neoplasm recurrence	37.27	9.74	34	76478	2013	32435001
Faecal calprotectin increased	37.16	9.74	29	76483	1383	32435631
Aplastic anaemia	36.90	9.74	64	76448	7309	32429705
Colitis	36.07	9.74	167	76345	33784	32403230
Acute kidney injury	35.55	9.74	482	76030	292986	32144028
Cortisol decreased	35.20	9.74	24	76488	926	32436088
Hypophysitis	35.16	9.74	33	76479	2026	32434988
Insulin-like growth factor increased	34.78	9.74	25	76487	1051	32435963
Fall	33.85	9.74	297	76215	195904	32241110
Crohn's disease	33.41	9.74	46	76466	4299	32432715
Chorioretinopathy	33.08	9.74	28	76484	1499	32435515
Glioma	31.91	9.74	16	76496	343	32436671
Hypertrophic cardiomyopathy	31.83	9.74	23	76489	975	32436039
Pneumoretroperitoneum	31.81	9.74	10	76502	56	32436958
Pelvic abscess	31.75	9.74	23	76489	979	32436035
Bronchiectasis	31.54	9.74	58	76454	6934	32430080
Lichen planus	31.33	9.74	22	76490	891	32436123
Epiphysiolysis	30.90	9.74	11	76501	95	32436919
Drug hypersensitivity	30.53	9.74	285	76227	73115	32363899
Cardiac failure	30.38	9.74	112	76400	91561	32345453
Meningitis candida	29.79	9.74	10	76502	71	32436943
Drug level below therapeutic	28.69	9.74	42	76470	4153	32432861
Anaemia	28.61	9.74	363	76149	223261	32213753
Flushing	27.99	9.74	146	76366	30981	32406033
Myelopathy	27.69	9.74	29	76483	2034	32434980
Therapeutic response shortened	27.68	9.74	44	76468	4676	32432338
Pituitary haemorrhage	27.51	9.74	12	76500	185	32436829
Perioral dermatitis	26.28	9.74	10	76502	106	32436908
Growth retardation	26.17	9.74	26	76486	1713	32435301
Sedation	25.71	9.74	6	76506	18520	32418494
Stevens-Johnson syndrome	25.27	9.74	99	76413	18610	32418404
Candida infection	24.41	9.74	91	76421	16712	32420302
Adrenocorticotropic hormone deficiency	24.33	9.74	16	76496	581	32436433
Thermophobia	24.30	9.74	9	76503	88	32436926
Idiopathic intracranial hypertension	23.57	9.74	16	76496	613	32436401
Shared psychotic disorder	23.44	9.74	6	76506	13	32437001
Atrial fibrillation	23.17	9.74	170	76342	116534	32320480
Cardio-respiratory arrest	23.05	9.74	62	76450	55927	32381087
Blood pressure increased	22.72	9.74	286	76226	79068	32357946
Symptom masked	22.34	9.74	15	76497	564	32436450
Blood creatine phosphokinase increased	22.20	9.74	46	76466	45430	32391584
Hallucination	21.87	9.74	58	76454	52561	32384453
Klebsiella infection	21.68	9.74	54	76458	7958	32429056
Gastrointestinal haemorrhage	21.64	9.74	118	76394	86764	32350250
Thyroxine free decreased	21.56	9.74	11	76501	245	32436769
Periorbital infection	21.54	9.74	9	76503	124	32436890
Posterior reversible encephalopathy syndrome	21.30	9.74	60	76452	9516	32427498
Cardiac failure congestive	21.27	9.74	115	76397	84737	32352277
Glioblastoma multiforme	21.07	9.74	17	76495	851	32436163
Musculoskeletal injury	20.98	9.74	9	76503	133	32436881
Optic nerve disorder	20.71	9.74	15	76497	638	32436376
Neurotoxicity	20.56	9.74	80	76432	14990	32422024
Onychoclasis	20.49	9.74	23	76489	1745	32435269
Cholangitis infective	20.41	9.74	11	76501	275	32436739
Erythema	20.28	9.74	291	76221	82814	32354200
Astrocytoma	20.17	9.74	10	76502	209	32436805
Neuroleptic malignant syndrome	20.07	9.74	8	76504	17487	32419527
Subdural haematoma	20.00	9.74	11	76501	19942	32417072
Blood growth hormone decreased	19.98	9.74	6	76506	28	32436986
Rash erythematous	19.96	9.74	110	76402	23829	32413185
Dermatitis diaper	19.71	9.74	11	76501	295	32436719
Bronchial haemorrhage	19.35	9.74	15	76497	708	32436306
Blood growth hormone increased	19.23	9.74	10	76502	232	32436782
Hypogonadism	19.22	9.74	22	76490	1705	32435309
Pituitary tumour recurrent	19.12	9.74	7	76505	66	32436948
Drug level decreased	19.11	9.74	45	76467	6401	32430613
Vestibular neuronitis	18.88	9.74	9	76503	172	32436842
Renal failure	18.81	9.74	214	76298	134264	32302750
Secondary adrenocortical insufficiency	18.55	9.74	18	76494	1152	32435862
Anaphylactic reaction	18.46	9.74	128	76384	30044	32406970
Extrapyramidal disorder	18.30	9.74	3	76509	11892	32425122
Anal fistula	17.93	9.74	35	76477	4376	32432638
Diarrhoea haemorrhagic	17.91	9.74	43	76469	6192	32430822
Pouchitis	17.84	9.74	14	76498	673	32436341
Gastrointestinal inflammation	17.74	9.74	29	76483	3155	32433859
Meningitis tuberculous	17.66	9.74	14	76498	683	32436331
Gastrointestinal anastomotic leak	17.61	9.74	11	76501	365	32436649
Cryptococcal fungaemia	17.55	9.74	7	76505	85	32436929
Syncope	17.53	9.74	132	76380	89992	32347022
Splenic peliosis	17.47	9.74	5	76507	19	32436995
Hyperbilirubinaemia	17.22	9.74	85	76427	17645	32419369
Otitis media acute	17.18	9.74	12	76500	482	32436532
Blood thyroid stimulating hormone decreased	17.16	9.74	22	76490	1918	32435096
Intentional product misuse	17.15	9.74	37	76475	36014	32401000
Nervous system disorder	17.11	9.74	72	76440	13977	32423037
Clostridium difficile infection	17.06	9.74	85	76427	17711	32419303
Bone cyst	17.01	9.74	13	76499	601	32436413
Angina pectoris	16.90	9.74	30	76482	31396	32405618
Hospitalisation	16.76	9.74	59	76453	48912	32388102
Aggression	16.68	9.74	43	76469	39346	32397668
Joint ankylosis	16.64	9.74	11	76501	403	32436611
Chills	16.57	9.74	267	76245	77817	32359197
Lacrimal duct neoplasm	16.37	9.74	5	76507	25	32436989
Mantle cell lymphoma stage III	16.37	9.74	5	76507	25	32436989
Posturing	16.34	9.74	12	76500	522	32436492
Lactic acidosis	16.30	9.74	34	76478	33502	32403512
Hyperkalaemia	16.15	9.74	97	76415	69653	32367361
Eczema	16.14	9.74	74	76438	14906	32422108
Product quality issue	16.05	9.74	13	76499	19220	32417794
Pituitary tumour	16.02	9.74	12	76500	538	32436476
Poor venous access	15.85	9.74	27	76485	3039	32433975
Body height below normal	15.81	9.74	9	76503	251	32436763
Cerebrospinal fluid leakage	15.50	9.74	11	76501	453	32436561
Electrocardiogram QT prolonged	15.50	9.74	45	76467	39596	32397418
Body temperature decreased	15.46	9.74	59	76453	10955	32426059
Thyroxine decreased	15.43	9.74	7	76505	119	32436895
Anal inflammation	15.26	9.74	10	76502	361	32436653
Abdominal pain	15.21	9.74	460	76052	149069	32287945
Congenital cardiovascular anomaly	15.17	9.74	8	76504	191	32436823
Intentional self-injury	14.92	9.74	7	76505	13893	32423121
Coma	14.81	9.74	51	76461	42561	32394453
Addison's disease	14.70	9.74	4	76508	12	32437002
Renal disorder	14.50	9.74	23	76489	25160	32411854
Cushingoid	14.42	9.74	24	76488	2650	32434364
Anal abscess	14.42	9.74	37	76475	5553	32431461
Groin infection	14.22	9.74	7	76505	144	32436870
Pulmonary arterial hypertension	13.99	9.74	3	76509	9818	32427196
Perirectal abscess	13.85	9.74	18	76494	1591	32435423
Gingival disorder	13.84	9.74	17	76495	1420	32435594
Lichenification	13.70	9.74	9	76503	326	32436688
Feeling hot	13.68	9.74	77	76435	16809	32420205
Anaplastic astrocytoma	13.55	9.74	7	76505	160	32436854
Perineal pain	13.42	9.74	13	76499	830	32436184
Feeling cold	13.38	9.74	53	76459	10011	32427003
Mean cell volume decreased	13.33	9.74	16	76496	1304	32435710
Gastroenteritis	13.32	9.74	67	76445	14014	32423000
Coronary artery disease	13.22	9.74	66	76446	49640	32387374
Hydrocephalus	13.22	9.74	32	76480	4633	32432381
Prothrombin level abnormal	13.07	9.74	6	76506	105	32436909
Short-bowel syndrome	12.98	9.74	8	76504	259	32436755
Contraindicated product prescribed	12.94	9.74	9	76503	359	32436655
Respiratory disorder	12.85	9.74	84	76428	19333	32417681
Morganella infection	12.85	9.74	10	76502	475	32436539
Clostridium test positive	12.77	9.74	21	76491	2296	32434718
Somnolence	12.68	9.74	170	76342	103627	32333387
Sitting disability	12.67	9.74	6	76506	113	32436901
Blood luteinising hormone decreased	12.67	9.74	6	76506	113	32436901
Pharyngitis bacterial	12.66	9.74	5	76507	59	32436955
Hypothalamo-pituitary disorder	12.65	9.74	12	76500	747	32436267
Adenoidal hypertrophy	12.62	9.74	6	76506	114	32436900
Oxygen saturation abnormal	12.61	9.74	15	76497	1211	32435803
Cerebral infarction	12.59	9.74	29	76483	27585	32409429
Shunt malfunction	12.57	9.74	7	76505	187	32436827
Transient aphasia	12.53	9.74	6	76506	116	32436898
Toxic epidermal necrolysis	12.38	9.74	87	76425	20506	32416508
Phaeochromocytoma crisis	12.37	9.74	5	76507	63	32436951
Paraesthesia	12.29	9.74	201	76311	58743	32378271
Intestinal stenosis	12.26	9.74	19	76493	1976	32435038
Hepatic function abnormal	12.23	9.74	59	76453	44781	32392233
Blood corticotrophin increased	12.23	9.74	5	76507	65	32436949
Epileptic encephalopathy	12.21	9.74	6	76506	123	32436891
Trichosporon infection	12.17	9.74	12	76500	783	32436231
Wrong technique in product usage process	12.16	9.74	42	76470	35017	32401997
Foetal exposure during pregnancy	12.07	9.74	53	76459	41248	32395766
Blood creatinine increased	11.91	9.74	157	76355	95975	32341039
Administration site bruise	11.88	9.74	3	76509	6	32437008
Congenital adrenal gland hypoplasia	11.88	9.74	3	76509	6	32437008
Accidental overdose	11.78	9.74	17	76495	19322	32417692
Malignant neoplasm progression	11.73	9.74	123	76389	78373	32358641
Anal fissure	11.72	9.74	23	76489	2886	32434128
Tendonitis	11.61	9.74	46	76466	8689	32428325
Blood culture positive	11.60	9.74	32	76480	5013	32432001
Bradycardia	11.58	9.74	110	76402	71452	32365562
Drug ineffective	11.45	9.74	1049	75463	382428	32054586
Hepatitis C	11.45	9.74	9	76503	13509	32423505
Serotonin syndrome	11.45	9.74	17	76495	19100	32417914
Rectal abscess	11.45	9.74	13	76499	999	32436015
Unmasking of previously unidentified disease	11.42	9.74	11	76501	698	32436316
Hyperthyroidism	11.42	9.74	48	76464	9314	32427700
Pyrexia	11.40	9.74	887	75625	319081	32117933
Blood pressure diastolic decreased	11.32	9.74	40	76472	7157	32429857
Proteus infection	11.22	9.74	12	76500	862	32436152
Tooth injury	11.21	9.74	12	76500	863	32436151
Dactylitis	11.21	9.74	10	76502	575	32436439
Tracheobronchitis	11.18	9.74	13	76499	1025	32435989
Platelet count decreased	11.16	9.74	196	76316	114395	32322619
Febrile convulsion	11.16	9.74	10	76502	578	32436436
Pallor	11.14	9.74	92	76420	22789	32414225
Proctitis	11.07	9.74	20	76492	2358	32434656
Kounis syndrome	11.07	9.74	18	76494	1950	32435064
Melaena	11.05	9.74	43	76469	34622	32402392
Suicidal ideation	11.05	9.74	49	76463	38034	32398980
Myelitis transverse	11.05	9.74	13	76499	1038	32435976
Depressed level of consciousness	11.00	9.74	54	76458	40793	32396221
Peritonitis bacterial	11.00	9.74	8	76504	12488	32424526
Pneumonia	10.96	9.74	705	75807	354547	32082467
Abdominal abscess	10.95	9.74	28	76484	4193	32432821
Osteolysis	10.94	9.74	17	76495	1772	32435242
Respiratory depression	10.94	9.74	9	76503	13202	32423812
Antibody test abnormal	10.92	9.74	6	76506	156	32436858
Diplegia	10.89	9.74	13	76499	1054	32435960
Delirium	10.86	9.74	60	76452	43986	32393028
Therapy cessation	10.85	9.74	13	76499	16000	32421014
Hyperamylasaemia	10.81	9.74	10	76502	603	32436411
Hypernatraemia	10.66	9.74	43	76469	8190	32428824
Psychotic disorder	10.64	9.74	24	76488	22996	32414018
Cortisol abnormal	10.63	9.74	4	76508	41	32436973
Rhabdomyolysis	10.63	9.74	104	76408	67161	32369853
Functional gastrointestinal disorder	10.60	9.74	19	76493	2227	32434787
Peptic ulcer haemorrhage	10.57	9.74	9	76503	486	32436528
Leptotrichia infection	10.57	9.74	5	76507	94	32436920
Gonadotrophin deficiency	10.55	9.74	4	76508	42	32436972
Urticaria	10.54	9.74	198	76314	59416	32377598
Mental fatigue	10.42	9.74	5	76507	97	32436917
Drug-induced liver injury	10.39	9.74	26	76486	24037	32412977
Retinal scar	10.27	9.74	7	76505	270	32436744
Hypersensitivity	10.26	9.74	192	76320	57566	32379448
Inflammatory bowel disease	10.26	9.74	20	76492	2498	32434516
Spondylolisthesis	10.21	9.74	11	76501	797	32436217
Pharyngitis streptococcal	10.15	9.74	18	76494	2092	32434922
Gastric ulcer perforation	10.03	9.74	12	76500	975	32436039
Strongyloidiasis	10.02	9.74	20	76492	2541	32434473
Hepatic cirrhosis	10.02	9.74	15	76497	16794	32420220
Mucosal hyperaemia	9.99	9.74	3	76509	14	32437000
Skin injury	9.96	9.74	13	76499	1154	32435860
Haemorrhoidal haemorrhage	9.96	9.74	23	76489	3231	32433783
Arm amputation	9.94	9.74	5	76507	108	32436906
Graft versus host disease	9.93	9.74	51	76461	10755	32426259
Gastroenterostomy	9.92	9.74	4	76508	50	32436964
Cerebral haemorrhage	9.90	9.74	45	76467	34702	32402312
Secondary hypothyroidism	9.85	9.74	5	76507	110	32436904
Vitamin E deficiency	9.82	9.74	3	76509	15	32436999

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	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	S01BA02	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Corticosteroids, plain
ATC	S01CB03	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION Corticosteroids/antiinfectives/mydriatics in combination
ATC	S02BA01	SENSORY ORGANS OTOLOGICALS CORTICOSTEROIDS Corticosteroids
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	R01AD60	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
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	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 agents
CHEBI has role	CHEBI:50857	anti-allergic agents
CHEBI has role	CHEBI:75771	Mus musculus metabolite
CHEBI has role	CHEBI:77746	H. sapiens metabolites
CHEBI has role	CHEBI:88188	allergenic drug

Drug Use (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

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
5%;1%	XERESE	BAUSCH	N022436	July 31, 2009	RX	CREAM	TOPICAL	7223387	Nov. 13, 2022	COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION HEALING TIME IN ADULTS AND CHILDREN (6 YEARS OF AGE AND OLDER)
5%;1%	XERESE	BAUSCH	N022436	July 31, 2009	RX	CREAM	TOPICAL	7223387	Nov. 13, 2022	NEW COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION HEALING TIME IN ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND OLDER)
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])	Mechanism action	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_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
2868	IUPHAR_LIGAND_ID
38	INN_ID
WI4X0X7BPJ	UNII
202643	RXNORM
174	MMSL
2500	MMSL
4837	MMSL
d00254	MMSL
002147	NDDF
16602005	SNOMEDCT_US
396458002	SNOMEDCT_US

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	0009-0031	TABLET	10 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
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	0113-1369	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	0115-1697	TABLET	10 mg	ORAL	ANDA	14 sections
HYDROCORTISONE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1700	TABLET	20 mg	ORAL	ANDA	14 sections
HYDROCORTISONE	HUMAN 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
Hydrocortisone	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0080	CREAM	25 mg	TOPICAL	ANDA	17 sections
Hydrocortisone	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0146	OINTMENT	25 mg	TOPICAL	ANDA	17 sections
Hydrocortisone	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0288	LOTION	25 mg	TOPICAL	ANDA	18 sections
Texacort	HUMAN PRESCRIPTION DRUG LABEL	1	0178-0455	SOLUTION	25 mg	TOPICAL	ANDA	20 sections
KAISER PERMANENTEHydrocortisone	HUMAN OTC DRUG LABEL	1	0179-8711	OINTMENT	1 g	TOPICAL	OTC monograph not final	15 sections
Xerese	HUMAN PRESCRIPTION DRUG LABEL	2	0187-5104	CREAM	10 mg	TOPICAL	NDA	26 sections
Alacort	HUMAN PRESCRIPTION DRUG LABEL	1	0316-0126	CREAM	10 mg	TOPICAL	ANDA	19 sections
Alacort	HUMAN PRESCRIPTION DRUG LABEL	1	0316-0128	CREAM	25 mg	TOPICAL	ANDA	19 sections
Hydrocortisone	HUMAN PRESCRIPTION DRUG LABEL	1	0316-0186	CREAM	10 mg	TOPICAL	ANDA	19 sections
Hydrocortisone	HUMAN PRESCRIPTION DRUG LABEL	1	0316-0193	CREAM	25 mg	TOPICAL	ANDA	19 sections
Sarna Whipped Foam	HUMAN OTC DRUG LABEL	1	0316-0291	AEROSOL, FOAM	10 mg	TOPICAL	OTC monograph not final	11 sections