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Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
steroids, progestogens	2279	57-83-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: progesterone gestone gestormone glanducorpin lugesteron lugesterone progestan progeston progestone progestron progesterol syngesterone	The major progestational steroid that is secreted primarily by the CORPUS LUTEUM and the PLACENTA. Progesterone acts on the UTERUS, the MAMMARY GLANDS and the BRAIN. It is required in EMBRYO IMPLANTATION; PREGNANCY maintenance, and the development of mammary tissue for MILK production. Progesterone, converted from PREGNENOLONE, also serves as an intermediate in the biosynthesis of GONADAL STEROID HORMONES and adrenal CORTICOSTEROIDS. Molecular weight: 314.47 Formula: C21H30O2 CLOGP: 3.96 LIPINSKI: 0 HAC: 2 HDO: 0 TPSA: 34.14 ALOGS: -4.76 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

progesterone
gestone
gestormone
glanducorpin
lugesteron
lugesterone
progestan
progeston
progestone
progestron
progesterol
syngesterone

The major progestational steroid that is secreted primarily by the CORPUS LUTEUM and the PLACENTA. Progesterone acts on the UTERUS, the MAMMARY GLANDS and the BRAIN. It is required in EMBRYO IMPLANTATION; PREGNANCY maintenance, and the development of mammary tissue for MILK production. Progesterone, converted from PREGNENOLONE, also serves as an intermediate in the biosynthesis of GONADAL STEROID HORMONES and adrenal CORTICOSTEROIDS.

Molecular weight: 314.47
Formula: C21H30O2
CLOGP: 3.96
LIPINSKI: 0
HAC: 2
HDO: 0
TPSA: 34.14
ALOGS: -4.76
ROTB: 1

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.30	g	O
5	mg	P
0.20	g	R
90	mg	V

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.01 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	21.20 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	18 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	3.444		Moderate	0.71
caco2-efflux	Caco-2 efflux ratio (BA/AB)	0.440		Moderate	0.71
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	76.560	10^-6 cm/s	Moderate	0.71
dh-clint	Dog hepatocyte intrinsic clearance	82.414	uL/min/10^6 cells	Moderate	0.71
dppb	Dog plasma protein binding (% unbound)	4.560	%	Moderate	0.71
fcs-ppb	Fetal calf serum protein binding (% unbound)	6.060	%	Moderate	0.71
herg	hERG pIC50	4.635	pIC50	Moderate	0.71
hh-clint	Human hepatocyte intrinsic clearance	42.954	uL/min/10^6 cells	Moderate	0.71
hlm-clint	Human liver microsomal intrinsic clearance	103.753	uL/min/mg protein	Moderate	0.71
hppb	Human plasma protein binding (% unbound)	3.740	%	Moderate	0.71
kinase-safety-class	ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK	19
kinase-selectivity-class	EIF2AK3,GRK2	2
mdck-mdr1-bcrp-efflux	MDCK-MDR1-BCRP efflux ratio	0.367		Moderate	0.71
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	0.441		Moderate	0.71
mh-clint	Mouse hepatocyte intrinsic clearance	314.051		Moderate	0.71
mppb	Mouse plasma protein binding (% unbound)	5.990		Moderate	0.71
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	0.942		Moderate	0.71
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pppb	Pig plasma protein binding (% unbound)	7.410	%	Moderate	0.71
rat-kpuu-brain	Rat brain Kpuu	2.004	%	Moderate	0.71
rh-clint	Rat hepatocyte intrinsic clearance	275.423	uL/min/10^6 cells	Moderate	0.71
rh-fuinc	Rat hepatocyte fraction unbound in incubation	41.510	%	Moderate	0.71
rppb	Rat plasma protein binding (% unbound)	6.550	%	Moderate	0.71
solubility-dd	Solubility at pH 7.4 in DMSO	33.497	uM	Moderate	0.71

Approvals:

Date	Agency	Company	Orphan
Feb. 4, 1976	FDA	ALZA
Sept. 27, 2021	PMDA	FUJI PHARMA CO., LTD.

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
Ovarian hyperstimulation syndrome	1349.69	12.11	355	45277	5507	90577308
Food allergy	1025.01	12.11	410	45222	25068	90557747
Temperature regulation disorder	915.33	12.11	325	45307	14254	90568561
Immunodeficiency	820.00	12.11	411	45221	42823	90539992
Exposure during pregnancy	767.13	12.11	760	44872	237650	90345165
Rash erythematous	619.91	12.11	394	45238	64710	90518105
Hyperhidrosis	529.99	12.11	483	45149	135822	90446993
Foetal death	501.67	12.11	233	45399	20490	90562325
Coeliac disease	472.53	12.11	289	45343	44321	90538494
Upper respiratory tract infection	417.24	12.11	412	45220	127906	90454909
Abortion spontaneous	414.66	12.11	286	45346	53770	90529045
Fluid retention	399.85	12.11	341	45291	87750	90495065
Foetal exposure during pregnancy	352.43	12.11	237	45395	42738	90540077
Prescribed overdose	331.31	12.11	321	45311	97304	90485511
Intentional product misuse	325.65	12.11	306	45326	89298	90493517
Maternal exposure during pregnancy	278.71	12.11	581	45051	359482	90223333
Overdose	250.87	12.11	351	45281	157358	90425457
Asthma	246.42	12.11	439	45193	241721	90341094
Bursitis	216.80	12.11	298	45334	131356	90451459
Premature labour	209.71	12.11	112	45520	13264	90569551
Erythema	206	12.11	394	45238	228852	90353963
Premature delivery	196.36	12.11	160	45472	38602	90544213
Product use issue	191.22	12.11	475	45157	329444	90253371
Headache	187.98	12.11	894	44738	861852	89720963
Product adhesion issue	166.75	12.11	71	45561	5071	90577744
Psoriasis	165.97	12.11	280	45352	147474	90435341
Pemphigus	149.85	12.11	3	45629	326861	90255954
Hepatic enzyme increased	140.69	12.11	450	45182	360286	90222529
Gestational diabetes	139.41	12.11	79	45553	10503	90572312
Off label use	135.97	12.11	983	44649	1101269	89481546
Systemic lupus erythematosus	135.21	12.11	13	45619	361883	90220932
Constipation	134.10	12.11	376	45256	280019	90302796
Vaginal haemorrhage	133.52	12.11	117	45515	31154	90551661
Glossodynia	133.29	12.11	7	45625	321772	90261043
Back pain	133.19	12.11	406	45226	316769	90266046
Meningioma	132.01	12.11	60	45572	5011	90577804
Synovitis	131.07	12.11	9	45623	329743	90253072
Rheumatoid arthritis	126.81	12.11	436	45196	362178	90220637
Atrial septal defect	126.41	12.11	68	45564	8166	90574649
Wound	121.20	12.11	8	45624	302972	90279843
Hypersensitivity	121.12	12.11	501	45131	454176	90128639
Thrombocytopenia	120.19	12.11	300	45332	208425	90374390
Autoimmune dermatitis	118.22	12.11	25	45607	137	90582678
Premature baby	113.48	12.11	97	45535	24980	90557835
Death	111.86	12.11	45	45587	456506	90126309
Pericarditis	111.48	12.11	6	45626	270145	90312670
Pneumonia	108.66	12.11	97	45535	637962	89944853
Eosinophilic pneumonia acute	103.06	12.11	30	45602	685	90582130
Arthropathy	102.03	12.11	29	45603	366213	90216602
Postmenopausal haemorrhage	97.25	12.11	39	45593	2391	90580424
General physical health deterioration	88.60	12.11	34	45598	355081	90227734
Folliculitis	79.94	12.11	6	45626	204347	90378468
Hot flush	79.38	12.11	122	45510	59366	90523449
Small for dates baby	78.68	12.11	42	45590	4965	90577850
Decreased immune responsiveness	78.34	12.11	51	45581	8697	90574118
Acute kidney injury	77.74	12.11	32	45600	320355	90262460
Oligohydramnios	77.06	12.11	47	45585	7154	90575661
Hepatic necrosis	76.64	12.11	45	45587	6393	90576422
Toxicity to various agents	74.42	12.11	26	45606	287820	90294995
Ectopic pregnancy	73.94	12.11	35	45597	3206	90579609
Butterfly rash	73.60	12.11	31	45601	2154	90580661
Swelling	73.31	12.11	62	45570	418996	90163819
Blister	73.22	12.11	19	45613	254979	90327836
Stomatitis	72.42	12.11	24	45608	274674	90308141
Abdominal discomfort	71.52	12.11	81	45551	477247	90105568
Ventricular septal defect	70.23	12.11	40	45592	5367	90577448
Impaired healing	70.08	12.11	16	45616	234183	90348632
Wheezing	69.79	12.11	17	45615	238063	90344752
Drug hypersensitivity	69.65	12.11	435	45197	463174	90119641
Premature rupture of membranes	69.21	12.11	40	45592	5518	90577297
Intermenstrual bleeding	68.78	12.11	48	45584	9175	90573640
Peripheral swelling	67.62	12.11	65	45567	413041	90169774
Maternal exposure before pregnancy	66.92	12.11	51	45581	11162	90571653
Muscle injury	66.84	12.11	6	45626	176648	90406167
Liver injury	66.74	12.11	5	45627	170562	90412253
Mobility decreased	65.93	12.11	22	45610	250712	90332103
Congenital absence of vertebra	62.52	12.11	12	45620	36	90582779
Lower respiratory tract infection	62.49	12.11	24	45608	250635	90332180
Placenta accreta	62.23	12.11	16	45616	225	90582590
Confusional state	61.78	12.11	62	45570	386143	90196672
Irritable bowel syndrome	60.43	12.11	15	45617	207433	90375382
Therapeutic product effect decreased	59.25	12.11	33	45599	277538	90305277
Pre-eclampsia	58.88	12.11	47	45585	11001	90571814
Dermatitis atopic	57.66	12.11	65	45567	23407	90559408
Congenital vesicoureteric reflux	54.97	12.11	10	45622	20	90582795
Decreased appetite	54.11	12.11	66	45566	376474	90206341
Sleep disorder due to general medical condition, insomnia type	52.62	12.11	3	45629	128691	90454124
Hypertension	52.51	12.11	402	45230	457130	90125685
Ovarian enlargement	51.82	12.11	17	45615	583	90582232
Vomiting	51.71	12.11	213	45419	788080	89794735
Type 2 diabetes mellitus	51.42	12.11	19	45613	203225	90379590
Decidual cast	50.21	12.11	8	45624	3	90582812
Pregnancy	49.99	12.11	102	45530	61945	90520870
Vulvovaginal discomfort	49.19	12.11	25	45607	2672	90580143
Preterm premature rupture of membranes	47.77	12.11	21	45611	1620	90581195
Abortion threatened	47.74	12.11	16	45616	587	90582228
Ill-defined disorder	47.25	12.11	17	45615	184874	90397941
Anaemia	46.43	12.11	66	45566	352736	90230079
Neutropenia	46.20	12.11	28	45604	224876	90357939
Hepatic encephalopathy	46.11	12.11	45	45587	13727	90569088
Lung disorder	45.30	12.11	10	45622	149873	90432942
Ascites	43.93	12.11	83	45549	47657	90535158
Musculoskeletal stiffness	42.56	12.11	52	45580	296480	90286335
Oedema	42.46	12.11	24	45608	200271	90382544
Product odour abnormal	42.19	12.11	19	45613	1552	90581263
Haemorrhage in pregnancy	42.04	12.11	21	45611	2164	90580651
Subdural hygroma	41.56	12.11	12	45620	266	90582549
Uterine haemorrhage	40.83	12.11	27	45605	4725	90578090
Abnormal uterine bleeding	40.67	12.11	20	45612	1992	90580823
Blood oestrogen decreased	40.60	12.11	13	45619	412	90582403
Dyspnoea	39.37	12.11	271	45361	880684	89702131
Joint range of motion decreased	39.12	12.11	10	45622	135633	90447182
Progesterone decreased	39.07	12.11	10	45622	138	90582677
Diarrhoea	39.03	12.11	295	45337	938895	89643920
Phyllodes tumour	38.87	12.11	9	45623	79	90582736
Ovarian abscess	38.61	12.11	11	45621	232	90582583
Injury	38.57	12.11	26	45606	197323	90385492
Infusion related reaction	38.08	12.11	348	45284	416432	90166383
Abortion missed	37.99	12.11	19	45613	1963	90580852
Pulmonary hypoplasia	37.95	12.11	12	45620	365	90582450
Pain	37.70	12.11	707	44925	995634	89587181
Adnexal torsion	37.69	12.11	13	45619	521	90582294
Completed suicide	37.64	12.11	13	45619	145045	90437770
Sepsis	37.47	12.11	22	45610	179792	90403023
Retching	37.09	12.11	47	45585	19112	90563703
Ovarian haemorrhage	36.93	12.11	12	45620	399	90582416
Gastroschisis	36.73	12.11	12	45620	406	90582409
C-reactive protein increased	36.67	12.11	23	45609	181366	90401449
Hormone level abnormal	36.63	12.11	21	45611	2852	90579963
Periorbital oedema	36.39	12.11	29	45603	6770	90576045
Gastrointestinal disorder	35.80	12.11	46	45586	256641	90326174
Grip strength decreased	35.40	12.11	3	45629	92573	90490242
Liver disorder	34.86	12.11	9	45623	121260	90461555
Cardiac arrest	33.81	12.11	6	45626	104929	90477886
Injection site pain	33.23	12.11	174	45458	173525	90409290
Human herpesvirus 6 infection	33.18	12.11	21	45611	3411	90579404
Developmental hip dysplasia	32.77	12.11	16	45616	1569	90581246
Contraindicated product administered	32.70	12.11	274	45358	319865	90262950
Blood cholesterol increased	32.54	12.11	34	45598	207978	90374837
Condition aggravated	32.44	12.11	172	45460	595373	89987442
Caesarean section	31.96	12.11	43	45589	18534	90564281
Gait inability	31.83	12.11	17	45615	146439	90436376
Inflammation	31.71	12.11	26	45606	178566	90404249
Endometrial stromal sarcoma	31.51	12.11	6	45626	17	90582798
Fall	31.01	12.11	131	45501	481679	90101136
Single umbilical artery	30.99	12.11	10	45622	325	90582490
Retained placenta or membranes	30.96	12.11	10	45622	326	90582489
Pulmonary fibrosis	30.86	12.11	8	45624	107495	90475320
Breast hyperplasia	30.82	12.11	10	45622	331	90582484
Malignant neoplasm progression	30.59	12.11	8	45624	106862	90475953
HELLP syndrome	30.42	12.11	14	45618	1203	90581612
Breast tenderness	30.41	12.11	18	45614	2594	90580221
Alopecia	30.41	12.11	137	45495	494934	90087881
Photosensitivity reaction	30.30	12.11	41	45591	17766	90565049
Renal failure	30.29	12.11	14	45618	130993	90451822
Foetal growth restriction	30.19	12.11	30	45602	9350	90573465
Subchorionic haematoma	29.93	12.11	8	45624	132	90582683
Febrile neutropenia	29.44	12.11	22	45610	158327	90424488
Congenital multiplex arthrogryposis	29.15	12.11	7	45625	73	90582742
Suicidal behaviour	29.00	12.11	18	45614	2826	90579989
Peripheral venous disease	28.84	12.11	4	45628	83917	90498898
Hypotension	28.78	12.11	77	45555	325320	90257495
Psoriatic arthropathy	28.76	12.11	44	45588	228291	90354524
Periodic limb movement disorder	28.67	12.11	11	45621	599	90582216
Wound infection	28.54	12.11	9	45623	106393	90476422
Head discomfort	28.40	12.11	38	45594	16295	90566520
Joint swelling	28.37	12.11	382	45250	502918	90079897
Cyanosis neonatal	28.25	12.11	10	45622	433	90582382
Red blood cell sedimentation rate increased	28.24	12.11	4	45628	82591	90500224
Retroplacental haematoma	27.89	12.11	8	45624	173	90582642
Hepatotoxicity	27.50	12.11	67	45565	45775	90537040
Lower limb fracture	27.08	12.11	5	45627	85008	90497807
Twin pregnancy	27.06	12.11	13	45619	1230	90581585
Tinnitus	26.94	12.11	64	45568	43038	90539777
Application site pruritus	26.86	12.11	20	45612	4227	90578588
Ovarian cyst	26.67	12.11	38	45594	17280	90565535
Ophthalmic vein thrombosis	26.55	12.11	9	45623	342	90582473
Obesity	26.44	12.11	10	45622	105497	90477318
Neonatal asphyxia	26.25	12.11	9	45623	354	90582461
Malaise	26.24	12.11	180	45452	585806	89997009
Normal newborn	25.82	12.11	44	45588	23318	90559497
Rash	25.72	12.11	552	45080	795548	89787267
Uterine polyp	25.59	12.11	16	45616	2544	90580271
Respiratory disorder neonatal	25.59	12.11	13	45619	1388	90581427
In vitro fertilisation	25.50	12.11	8	45624	237	90582578
Hypotonia neonatal	25.34	12.11	13	45619	1417	90581398
Menopausal symptoms	25.27	12.11	17	45615	3061	90579754
Disease progression	25.17	12.11	25	45607	156590	90426225
Fibromyalgia	24.79	12.11	41	45591	206228	90376587
Renal impairment	24.79	12.11	11	45621	105410	90477405
Mediastinal effusion	24.29	12.11	6	45626	71	90582744
Discomfort	24.19	12.11	65	45567	274270	90308545
Cholestasis of pregnancy	24.14	12.11	13	45619	1564	90581251
Drug abuse	23.88	12.11	6	45626	82341	90500474
Haemoglobin decreased	23.65	12.11	28	45604	161928	90420887
Musculoskeletal pain	23.55	12.11	31	45601	171220	90411595
Pancytopenia	23.28	12.11	16	45616	120247	90462568
Liver function test increased	23.08	12.11	7	45625	84848	90497967
Hyperkalaemia	22.55	12.11	3	45629	64961	90517854
Pelvic infection	22.48	12.11	8	45624	352	90582463
Hippocampal sclerosis	22.44	12.11	6	45626	99	90582716
Asthenia	22.41	12.11	167	45465	533584	90049231
Chronic obstructive pulmonary disease	22.15	12.11	5	45627	73824	90508991
Cardiac failure congestive	22.12	12.11	11	45621	98683	90484132
Abortion	21.91	12.11	15	45617	2780	90580035
Abdominal pain upper	21.66	12.11	90	45542	332584	90250231
Osteoarthritis	21.63	12.11	41	45591	195689	90387126
Hypogonadism	21.50	12.11	6	45626	117	90582698
Application site irritation	21.50	12.11	13	45619	1948	90580867
Delirium	21.41	12.11	13	45619	104346	90478469
Patent ductus arteriosus	21.33	12.11	18	45614	4551	90578264
Application site erythema	21.25	12.11	19	45613	5189	90577626
Low birth weight baby	21.20	12.11	25	45607	9442	90573373
Tubo-ovarian abscess	20.84	12.11	8	45624	436	90582379
Talipes	20.68	12.11	12	45620	1668	90581147
Oedema peripheral	20.62	12.11	64	45568	257851	90324964
Complication of pregnancy	20.45	12.11	9	45623	696	90582119
Gastrointestinal haemorrhage	20.32	12.11	10	45622	90238	90492577
Dyslalia	20.29	12.11	9	45623	709	90582106
Sciatica	20.28	12.11	13	45619	101369	90481446
Therapeutic product effect incomplete	20.24	12.11	42	45590	193854	90388961
Secondary hypertension	19.94	12.11	7	45625	296	90582519
Congenital umbilical hernia	19.23	12.11	7	45625	329	90582486
Carnitine deficiency	19.12	12.11	6	45626	178	90582637
Pulmonary oedema	19.04	12.11	4	45628	62076	90520739
Heterotopic pregnancy	18.90	12.11	4	45628	22	90582793
Adjustment disorder with depressed mood	18.82	12.11	3	45629	56750	90526065
Taste disorder	18.81	12.11	4	45628	61542	90521273
Nail bed disorder	18.74	12.11	7	45625	354	90582461
Product administration interrupted	18.63	12.11	27	45605	12465	90570350
COVID-19	18.56	12.11	147	45485	168696	90414119
Primary hypogonadism	18.54	12.11	6	45626	197	90582618
Selective eating disorder	18.46	12.11	12	45620	2041	90580774
Avoidant personality disorder	18.45	12.11	5	45627	87	90582728
Hydrops foetalis	18.35	12.11	8	45624	605	90582210
Opisthotonus	18.27	12.11	7	45625	380	90582435
Abdominal pain lower	17.99	12.11	44	45588	30133	90552682
Application site rash	17.85	12.11	13	45619	2656	90580159
Alanine aminotransferase increased	17.77	12.11	20	45612	118318	90464497
Oestradiol increased	17.75	12.11	5	45627	101	90582714
Endometrial hyperplasia	17.64	12.11	9	45623	970	90581845
Temporal lobe epilepsy	17.63	12.11	7	45625	418	90582397
Eye irritation	17.62	12.11	47	45585	33931	90548884
Product use in unapproved indication	17.61	12.11	252	45380	335984	90246831
Hypercholesterolaemia	17.52	12.11	15	45617	100877	90481938
Dry mouth	17.46	12.11	42	45590	184017	90398798
Loss of personal independence in daily activities	17.35	12.11	26	45606	136079	90446736
Anti-Muellerian hormone level decreased	17.31	12.11	5	45627	111	90582704
Irritability	17.16	12.11	48	45584	35614	90547201
Bone erosion	17.15	12.11	3	45629	53018	90529797
Dysmenorrhoea	17.03	12.11	16	45616	4656	90578159
Pulmonary artery stenosis congenital	17.02	12.11	7	45625	458	90582357
Turner's syndrome	16.90	12.11	5	45627	121	90582694
White blood cell count decreased	16.77	12.11	37	45595	167072	90415743
Skin burning sensation	16.70	12.11	33	45599	19578	90563237
Atrial fibrillation	16.58	12.11	26	45606	133585	90449230
Cryptorchism	16.49	12.11	3	45629	6	90582809
Incorrect dose administered	16.44	12.11	81	45551	78849	90503966
Dislocation of vertebra	16.38	12.11	4	45628	55964	90526851
Hip arthroplasty	16.33	12.11	9	45623	76199	90506616
Depressed mood	16.29	12.11	59	45573	50163	90532652
Arthralgia	16.27	12.11	285	45347	778237	89804578
Endometrial disorder	16.12	12.11	8	45624	813	90582002
Fallopian tube disorder	16.09	12.11	7	45625	527	90582288
Rectal haemorrhage	16.02	12.11	11	45621	82733	90500082
Enlarged clitoris	16.01	12.11	5	45627	146	90582669
Nerve compression	16.00	12.11	23	45609	10543	90572272
Bicuspid aortic valve	15.91	12.11	5	45627	149	90582666
Bladder tamponade	15.85	12.11	5	45627	151	90582664
Nail disorder	15.83	12.11	5	45627	59062	90523753
Platelet count decreased	15.74	12.11	28	45604	136941	90445874
Dehydration	15.72	12.11	48	45584	194399	90388416
Palatal polyp	15.63	12.11	3	45629	9	90582806
Feeling abnormal	15.41	12.11	140	45492	167095	90415720
Therapeutic response unexpected	15.34	12.11	34	45598	21846	90560969
Hallucination	15.32	12.11	7	45625	65952	90516863
Intentional product use issue	15.18	12.11	57	45575	216835	90365980
Breast enlargement	15.15	12.11	10	45622	1745	90581070
Biochemical pregnancy	15.14	12.11	4	45628	63	90582752
Oesophageal atresia	14.98	12.11	7	45625	623	90582192
Knee arthroplasty	14.89	12.11	12	45620	83170	90499645
Drug exposure before pregnancy	14.89	12.11	8	45624	958	90581857
Ultrasound liver abnormal	14.85	12.11	4	45628	68	90582747
Injection site pruritus	14.79	12.11	60	45572	53774	90529041
Cervical incompetence	14.79	12.11	7	45625	641	90582174
Respiratory failure	14.73	12.11	23	45609	118395	90464420
Amniotic cavity infection	14.65	12.11	9	45623	1387	90581428
Mental disability	14.60	12.11	5	45627	196	90582619
Fatigue	14.57	12.11	715	44917	1153308	89429507
Nasopharyngitis	14.51	12.11	133	45499	406971	90175844
Postpartum haemorrhage	14.50	12.11	11	45621	2390	90580425
Ovarian cyst ruptured	14.33	12.11	9	45623	1443	90581372
Road traffic accident	14.27	12.11	20	45612	107606	90475209
Cardio-respiratory arrest	14.21	12.11	7	45625	63133	90519682
Pelvic fluid collection	14.20	12.11	8	45624	1051	90581764
Blood oestrogen increased	14.05	12.11	5	45627	220	90582595
Onychomadesis	14.03	12.11	3	45629	45995	90536820
Hypoglycaemia	13.91	12.11	9	45623	69839	90512976
Autoimmune disorder	13.83	12.11	11	45621	76733	90506082
Mucosal inflammation	13.56	12.11	6	45626	57619	90525196
Failed induction of labour	13.55	12.11	6	45626	471	90582344
Foreign body in reproductive tract	13.41	12.11	8	45624	1169	90581646
Heavy menstrual bleeding	13.39	12.11	31	45601	20499	90562316
Breast pain	13.38	12.11	21	45611	10397	90572418
Neoplasm progression	13.37	12.11	3	45629	44483	90538332
Vaginal discharge	13.37	12.11	30	45602	19434	90563381
Application site urticaria	13.35	12.11	5	45627	255	90582560
Endometrial cancer stage I	13.31	12.11	5	45627	257	90582558
Pelvic pain	13.27	12.11	26	45606	15331	90567484
Eosinophilic pneumonia	13.10	12.11	11	45621	2762	90580053
Cardiac failure	12.93	12.11	22	45610	109474	90473341
Brain compression	12.89	12.11	6	45626	529	90582286
Aspartate aminotransferase increased	12.80	12.11	20	45612	102917	90479898
Abortion early	12.79	12.11	3	45629	28	90582787
Endometrial thickening	12.66	12.11	6	45626	551	90582264
Product substitution issue	12.64	12.11	28	45604	17980	90564835
Agoraphobia	12.55	12.11	6	45626	562	90582253
Tumour invasion	12.52	12.11	5	45627	303	90582512
Plagiocephaly	12.49	12.11	4	45628	127	90582688
Premature separation of placenta	12.48	12.11	10	45622	2352	90580463
Hypoaesthesia	12.37	12.11	100	45532	314110	90268705
Surgery	12.31	12.11	50	45582	44837	90537978
Reaction to excipient	12.30	12.11	9	45623	1851	90580964
Electrocardiogram QT prolonged	12.30	12.11	11	45621	72445	90510370
Pyogenic granuloma	12.23	12.11	5	45627	322	90582493
Treatment failure	12.22	12.11	218	45414	303710	90279105
Waist circumference increased	12.21	12.11	7	45625	950	90581865
Binge eating	12.19	12.11	6	45626	599	90582216
Keratoconus	12.18	12.11	3	45629	35	90582780
Product taste abnormal	12.13	12.11	10	45622	2450	90580365

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
Foetal exposure during pregnancy	900.87	60.52	225	1258	47086	42572766
Premature baby	465.89	60.52	116	1367	23037	42596815
Atrial septal defect	175.06	60.52	43	1440	7876	42611976
Low birth weight baby	165.29	60.52	43	1440	9912	42609940
Hypospadias	151.73	60.52	33	1450	3534	42616318
Ventricular septal defect	134.11	60.52	31	1452	4368	42615484
Small for dates baby	98.30	60.52	25	1458	5238	42614614
Congenital hydronephrosis	92.24	60.52	17	1466	780	42619072
Maternal exposure during pregnancy	91.31	60.52	25	1458	6953	42612899
Human herpesvirus 6 infection	83.36	60.52	19	1464	2506	42617346
Keratoconus	72.80	60.52	11	1472	145	42619707
Neonatal respiratory distress syndrome	67.62	60.52	18	1465	4495	42615357
Patent ductus arteriosus	67.29	60.52	17	1466	3459	42616393

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
Ovarian hyperstimulation syndrome	1434.85	13.77	333	33995	5027	110549944
Temperature regulation disorder	920.25	13.77	281	34047	12545	110542426
Food allergy	817.50	13.77	286	34042	19662	110535309
Immunodeficiency	642.30	13.77	289	34039	38549	110516422
Coeliac disease	579.31	13.77	278	34050	42909	110512062
Exposure during pregnancy	515.79	13.77	422	33906	167002	110387969
Foetal death	485.58	13.77	184	34144	15861	110539110
Rash erythematous	452.40	13.77	294	34034	81538	110473433
Fluid retention	428.47	13.77	300	34028	94007	110460964
Upper respiratory tract infection	346.56	13.77	303	34025	131025	110423946
Hyperhidrosis	321.55	13.77	341	33987	186957	110368014
Bursitis	317.44	13.77	287	34041	129631	110425340
Maternal exposure during pregnancy	261.17	13.77	357	33971	254526	110300445
Prescribed overdose	236.81	13.77	205	34123	87376	110467595
Erythema	228.73	13.77	360	33968	291087	110263884
Asthma	218.68	13.77	325	34003	249966	110305005
Premature delivery	206.72	13.77	125	34203	30507	110524464
Headache	193.00	13.77	656	33672	881721	109673250
Psoriasis	190.57	13.77	226	34102	139767	110415204
Back pain	186.26	13.77	377	33951	370619	110184352
Rheumatoid arthritis	180.49	13.77	329	33999	299284	110255687
Hepatic enzyme increased	159.69	13.77	325	34003	320567	110234404
Constipation	157.91	13.77	345	33983	357441	110197530
Abortion spontaneous	157.72	13.77	110	34218	34172	110520799
Intentional product misuse	152.61	13.77	197	34131	132707	110422264
Premature labour	150.69	13.77	68	34260	9104	110545867
Product use issue	144.89	13.77	307	34021	311388	110243583
Drug hypersensitivity	130.75	13.77	372	33956	453718	110101253
Hypersensitivity	129.23	13.77	344	33984	403654	110151317
Meningioma	125.91	13.77	52	34276	5613	110549358
Vaginal haemorrhage	123.69	13.77	84	34244	24990	110529981
Gestational diabetes	118.91	13.77	54	34274	7335	110547636
Acute kidney injury	116.98	13.77	27	34301	635403	109919568
Death	113.21	13.77	38	34290	698831	109856140
Overdose	111.73	13.77	233	34095	233561	110321410
Autoimmune dermatitis	109.41	13.77	23	34305	212	110554759
Contraindicated product administered	105.56	13.77	236	34092	248031	110306940
Decreased immune responsiveness	93.99	13.77	50	34278	9556	110545415
Eosinophilic pneumonia acute	92.37	13.77	30	34298	1635	110553336
Butterfly rash	88.94	13.77	31	34297	2100	110552871
Pneumonia	86.43	13.77	87	34241	876627	109678344
Toxicity to various agents	83.40	13.77	23	34305	480532	110074439
Premature rupture of membranes	78.15	13.77	35	34293	4602	110550369
Hepatic necrosis	76.11	13.77	44	34284	9878	110545093
Pre-eclampsia	73.47	13.77	41	34287	8609	110546362
Product adhesion issue	71.60	13.77	29	34299	2977	110551994
Maternal exposure before pregnancy	71.60	13.77	38	34290	7227	110547744
Placenta accreta	70.88	13.77	16	34312	211	110554760
Ovarian enlargement	66.26	13.77	17	34311	395	110554576
Phyllodes tumour	66.05	13.77	13	34315	83	110554888
Synovitis	66.00	13.77	5	34323	274087	110280884
Pain	64.93	13.77	512	33816	954443	109600528
Intermenstrual bleeding	64.78	13.77	35	34293	6899	110548072
Off label use	63.07	13.77	726	33602	1499459	109055512
Keratoconus	57.90	13.77	13	34315	167	110554804
General physical health deterioration	57.72	13.77	30	34298	425265	110129706
Wound	57.24	13.77	4	34324	234433	110320538
Abnormal uterine bleeding	56.38	13.77	20	34308	1427	110553544
Fatigue	56.28	13.77	600	33728	1215358	109339613
Postmenopausal haemorrhage	55.21	13.77	21	34307	1825	110553146
Pemphigus	54.36	13.77	3	34325	214567	110340404
Decidual cast	54.08	13.77	8	34320	3	110554968
Haemorrhage in pregnancy	53.60	13.77	20	34308	1648	110553323
Anaemia	53.01	13.77	55	34273	547031	110007940
Neutropenia	52.98	13.77	25	34303	374595	110180376
Dermatitis atopic	51.89	13.77	51	34277	25490	110529481
Ovarian abscess	50.48	13.77	11	34317	122	110554849
Abortion threatened	50.13	13.77	14	34314	453	110554518
Hot flush	49.49	13.77	80	34248	65956	110489015
Systemic lupus erythematosus	48.36	13.77	10	34318	254328	110300643
Uterine haemorrhage	48.34	13.77	23	34305	3471	110551500
Pericarditis	47.50	13.77	6	34322	219108	110335863
Cardiac arrest	46.22	13.77	4	34324	196749	110358222
Glossodynia	45.96	13.77	7	34321	221997	110332974
Sepsis	44.53	13.77	23	34305	327323	110227648
Ovarian haemorrhage	44.23	13.77	12	34316	348	110554623
Ectopic pregnancy	44.09	13.77	19	34309	2278	110552693
Febrile neutropenia	43.47	13.77	22	34306	316745	110238226
Hypotension	42.94	13.77	60	34268	523789	110031182
Vulvovaginal discomfort	42.19	13.77	18	34310	2106	110552865
Retching	41.87	13.77	43	34285	22639	110532332
Decreased appetite	41.55	13.77	52	34276	475794	110079177
HELLP syndrome	41.45	13.77	14	34314	862	110554109
Normal newborn	41.31	13.77	42	34286	21854	110533117
Treatment failure	41.26	13.77	183	34145	277051	110277920
Renal failure	40.88	13.77	10	34318	226564	110328407
Confusional state	40.11	13.77	52	34276	468628	110086343
Joint swelling	39.61	13.77	254	34074	442591	110112380
Completed suicide	39.47	13.77	13	34315	242368	110312603
Caesarean section	38.64	13.77	33	34295	13784	110541187
Periorbital oedema	38.43	13.77	29	34299	10163	110544808
Arthropathy	37.93	13.77	21	34307	287501	110267470
Adnexal torsion	37.51	13.77	11	34317	425	110554546
Hepatic encephalopathy	37.38	13.77	45	34283	28211	110526760
Thrombocytopenia	36.85	13.77	209	34119	348676	110206295
Infusion related reaction	36.82	13.77	223	34105	380939	110174032
Breast hyperplasia	36.45	13.77	9	34319	178	110554793
Wheezing	36.12	13.77	17	34311	255213	110299758
Folliculitis	35.36	13.77	5	34323	167648	110387323
Hepatotoxicity	34.79	13.77	67	34261	63333	110491638
Injection site pain	34.06	13.77	127	34201	177795	110377176
Preterm premature rupture of membranes	33.98	13.77	14	34314	1501	110553470
Stomatitis	33.86	13.77	21	34307	270221	110284750
Ophthalmic vein thrombosis	33.48	13.77	9	34319	252	110554719
Head discomfort	33.24	13.77	35	34293	18965	110536006
Blood oestrogen decreased	33.01	13.77	9	34319	266	110554705
Twin pregnancy	32.67	13.77	12	34316	946	110554025
Drug abuse	31.67	13.77	8	34320	177403	110377568
Oligohydramnios	31.40	13.77	18	34310	3976	110550995
Impaired healing	31.25	13.77	11	34317	196706	110358265
Photosensitivity reaction	31.02	13.77	39	34289	25550	110529421
Malignant neoplasm progression	30.91	13.77	8	34320	174559	110380412
Hormone level abnormal	30.90	13.77	15	34313	2365	110552606
Blister	30.88	13.77	16	34312	227360	110327611
Suicidal behaviour	30.86	13.77	17	34311	3480	110551491
Ascites	30.56	13.77	80	34248	92728	110462243
Liver injury	30.55	13.77	5	34323	150408	110404563
Abortion missed	30.44	13.77	13	34315	1524	110553447
Uterine polyp	30.36	13.77	14	34314	1969	110553002
Menopausal symptoms	30.20	13.77	15	34313	2486	110552485
Renal impairment	29.15	13.77	11	34317	188434	110366537
Lower respiratory tract infection	28.95	13.77	20	34308	243086	110311885
Retained placenta or membranes	28.73	13.77	8	34320	256	110554715
Lung disorder	28.71	13.77	10	34318	180037	110374934
Peripheral swelling	28.61	13.77	51	34277	403983	110150988
Retroplacental haematoma	28.57	13.77	7	34321	134	110554837
Gastrointestinal haemorrhage	28.53	13.77	8	34320	165510	110389461
Endometrial stromal sarcoma	28.46	13.77	5	34323	15	110554956
Mobility decreased	27.66	13.77	20	34308	237402	110317569
Drug intolerance	27.50	13.77	218	34110	406294	110148677
Rash	27.30	13.77	381	33947	820583	109734388
Hypertension	26.94	13.77	259	34069	509825	110045146
Product odour abnormal	26.84	13.77	12	34316	1571	110553400
Mediastinal effusion	26.80	13.77	6	34322	76	110554895
Pancytopenia	26.66	13.77	16	34312	209597	110345374
Cholestasis of pregnancy	26.05	13.77	11	34317	1254	110553717
Diarrhoea	25.82	13.77	228	34100	1139277	109415694
Muscle injury	25.81	13.77	6	34322	140801	110414170
Eye irritation	25.70	13.77	41	34287	33411	110521560
Pelvic infection	25.18	13.77	8	34320	406	110554565
Tubo-ovarian abscess	25.18	13.77	8	34320	406	110554565
Ovarian cyst	24.97	13.77	26	34302	13904	110541067
Oestradiol increased	24.78	13.77	6	34322	109	110554862
Haemoglobin decreased	24.06	13.77	25	34303	248702	110306269
Pregnancy	23.31	13.77	50	34278	51017	110503954
Therapeutic product effect decreased	23.13	13.77	25	34303	244291	110310680
Tinnitus	22.88	13.77	55	34273	60485	110494486
Progesterone decreased	22.82	13.77	5	34323	57	110554914
Sleep disorder due to general medical condition, insomnia type	22.63	13.77	3	34325	105640	110449331
Liver disorder	22.51	13.77	8	34320	142235	110412736
Platelet count decreased	22.47	13.77	23	34305	230420	110324551
Abdominal pain lower	22.45	13.77	41	34287	37242	110517729
Nail bed disorder	22.25	13.77	7	34321	344	110554627
C-reactive protein increased	22.11	13.77	21	34307	217898	110337073
Irritable bowel syndrome	21.64	13.77	12	34316	164203	110390768
Oedema	21.58	13.77	20	34308	209956	110345015
Respiratory failure	21.56	13.77	21	34307	215311	110339660
Cardiac failure congestive	21.44	13.77	10	34318	150990	110403981
Chronic obstructive pulmonary disease	21.35	13.77	4	34324	109154	110445817
Pulmonary oedema	21.23	13.77	3	34325	100656	110454315
Disease progression	20.93	13.77	27	34301	244007	110310964
Heterotopic pregnancy	20.83	13.77	4	34324	22	110554949
Complication of pregnancy	20.77	13.77	7	34321	428	110554543
Vomiting	20.69	13.77	182	34146	910493	109644478
Fallopian tube disorder	20.63	13.77	7	34321	437	110554534
Depressed mood	20.61	13.77	53	34275	60756	110494215
Fall	20.50	13.77	107	34221	603375	109951596
Hypotonia neonatal	20.49	13.77	5	34323	94	110554877
Porphyria non-acute	20.46	13.77	8	34320	749	110554222
Rhabdomyolysis	20.41	13.77	6	34322	120395	110434576
Swelling face	20.31	13.77	69	34259	92252	110462719
Avoidant personality disorder	20.29	13.77	5	34323	98	110554873
Primary hypogonadism	20.26	13.77	6	34322	240	110554731
Abortion	20.21	13.77	10	34318	1644	110553327
Atrial fibrillation	20.12	13.77	25	34303	229617	110325354
Heavy menstrual bleeding	19.93	13.77	25	34303	16340	110538631
Anti-Muellerian hormone level decreased	19.75	13.77	5	34323	110	110554861
Ovarian cyst ruptured	19.61	13.77	9	34319	1252	110553719
Alanine aminotransferase increased	19.49	13.77	17	34311	183756	110371215
Oedema peripheral	19.43	13.77	46	34282	328614	110226357
Foetal growth restriction	19.42	13.77	12	34316	3038	110551933
Type 2 diabetes mellitus	19.28	13.77	16	34312	177216	110377755
Drug-induced liver injury	19.18	13.77	81	34247	119986	110434985
Subchorionic haematoma	19.14	13.77	5	34323	125	110554846
Foetal exposure during pregnancy	19.12	13.77	17	34311	7488	110547483
Dyspnoea	19.11	13.77	236	34092	1106636	109448335
Amniotic cavity infection	19.06	13.77	8	34320	899	110554072
Carnitine deficiency	18.97	13.77	6	34322	300	110554671
Postpartum haemorrhage	18.95	13.77	10	34318	1879	110553092
Failed induction of labour	18.84	13.77	6	34322	307	110554664
Secondary hypertension	18.54	13.77	7	34321	596	110554375
Skin burning sensation	18.51	13.77	28	34300	21797	110533174
Breast tenderness	18.39	13.77	11	34317	2629	110552342
Product administration interrupted	18.34	13.77	20	34308	11272	110543699
Abdominal discomfort	18.21	13.77	62	34266	393796	110161175
Pelvic fluid collection	18.06	13.77	8	34320	1025	110553946
Gait inability	17.92	13.77	10	34318	136366	110418605
Delirium	17.60	13.77	10	34318	135015	110419956
Dysmenorrhoea	17.58	13.77	12	34316	3598	110551373
Endometrial hyperplasia	17.51	13.77	7	34321	695	110554276
Joint range of motion decreased	17.40	13.77	8	34320	121824	110433147
Breast enlargement	17.11	13.77	9	34319	1680	110553291
Bradycardia	16.96	13.77	14	34314	155503	110399468
Nerve compression	16.84	13.77	19	34309	11118	110543853
Hirsutism	16.75	13.77	9	34319	1754	110553217
Dehydration	16.61	13.77	39	34289	279472	110275499
Nephrocalcinosis	16.51	13.77	9	34319	1805	110553166
Swelling	16.41	13.77	55	34273	350986	110203985
Placental insufficiency	16.34	13.77	8	34320	1286	110553685
Mental disability	16.19	13.77	5	34323	231	110554740
Endometrial thickening	16.07	13.77	6	34322	495	110554476
Ill-defined disorder	16.04	13.77	15	34313	156838	110398133
Cardio-respiratory arrest	15.95	13.77	8	34320	115828	110439143
Mucosal inflammation	15.92	13.77	5	34323	96136	110458835
COVID-19	15.78	13.77	130	34198	244930	110310041
Dyslalia	15.75	13.77	8	34320	1389	110553582
Cervical incompetence	15.56	13.77	6	34322	541	110554430
Hallucination	15.55	13.77	6	34322	101426	110453545
Grip strength decreased	15.55	13.77	3	34325	80171	110474800
White blood cell count decreased	15.30	13.77	30	34298	229360	110325611
Asthenia	15.06	13.77	139	34189	688860	109866111
Septic shock	15.04	13.77	16	34312	157512	110397459
Red blood cell sedimentation rate increased	15.04	13.77	3	34325	78299	110476672
Breast pain	15.02	13.77	17	34311	9983	110544988
Inflammation	14.96	13.77	23	34305	193215	110361756
Multiple organ dysfunction syndrome	14.95	13.77	15	34313	151695	110403276
Binge eating	14.74	13.77	6	34322	624	110554347
Peripheral venous disease	14.61	13.77	4	34324	84113	110470858
Hepatic cirrhosis	14.40	13.77	50	34278	67576	110487395
Salpingo-oophoritis	14.40	13.77	4	34324	127	110554844
Musculoskeletal stiffness	14.37	13.77	42	34286	279780	110275191
Blood glucose increased	14.36	13.77	12	34316	132484	110422487
Endometrial disorder	14.19	13.77	6	34322	686	110554285
Hepatic function abnormal	14.16	13.77	5	34323	89290	110465681
Myocardial infarction	13.80	13.77	24	34304	192059	110362912

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
Human herpesvirus 6 infection	45.25	35.95	15	515	45	113378
Congestive cardiomyopathy	38.97	35.95	14	516	57	113366

Pharmacologic Action:

Source	Code	Description
ATC	G03DA04	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM PROGESTOGENS Pregnen (4) derivatives
ATC	G03FA04	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM PROGESTOGENS AND ESTROGENS IN COMBINATION Progestogens and estrogens, fixed combinations
FDA CS	M0017672	Progesterone
MeSH PA	D003473	Neuromuscular Nondepolarizing Agents
MeSH PA	D009465	Neuromuscular Agents
MeSH PA	D009466	Neuromuscular Blocking Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D000081227	Neurosteroids
MeSH PA	D006728	Hormones
MeSH PA	D011372	Progestins
MeSH PA	D018377	Neurotransmitter Agents
FDA EPC	N0000175601	Progesterone
CHEBI has role	CHEBI:22587	antiviral agent
CHEBI has role	CHEBI:35469	antidepressant
CHEBI has role	CHEBI:35526	hypoglycemic agent
CHEBI has role	CHEBI:35554	cardiovascular drug
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:35623	anticonvulsant
CHEBI has role	CHEBI:35674	antihypertensive agent
CHEBI has role	CHEBI:49323	contraceptive drug
CHEBI has role	CHEBI:50249	anticoagulant
CHEBI has role	CHEBI:50646	bone density conservation agent
CHEBI has role	CHEBI:50779	appetite enhancer
CHEBI has role	CHEBI:59826	progestin
CHEBI has role	CHEBI:63726	neuroprotective agent
CHEBI has role	CHEBI:64946	anti-HIV agent
CHEBI has role	CHEBI:70709	progesterone receptor agonist
CHEBI has role	CHEBI:75771	mouse metabolite
CHEBI has role	CHEBI:77746	human metabolite

Related Drugs by ATC class:

G03DA Pregnen (4) derivatives 3 drugs

gestonorone hydroxyprogesterone caproate medroxyprogesterone

G03FA Progestogens and estrogens, fixed combinations 15 drugs

dienogest drospirenone dydrogesterone ethisterone etynodiol hydroxyprogesterone caproate levonorgestrel lynestrenol medroxyprogesterone megestrol acetate methylestrenolone norethisterone show all 15 →

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

Disease	Relation	SNOMED_ID	DOID
Contraception	indication	13197004
Dysfunctional uterine bleeding	indication	19155002
Atrophic vaginitis	indication	52441000
Secondary physiologic amenorrhea	indication	86030004
Secondary malignant neoplasm of kidney	indication	94360002
Postmenopausal osteoporosis	indication	102447009
Endometriosis	indication	129103003
Menopausal flushing	indication	198436008
Endometrial carcinoma	indication	254878006	DOID:2871
Infertility Secondary to Progesterone Deficiency	indication
Amenorrhea Secondary to Ovarian Dysfunction	indication
Prevention of Premature Labor	indication
Endometrial Hyperplasia Prevention	indication
Corpus Luteum Insufficiency Syndrome	indication
Polycystic ovaries	off-label use	69878008
Menorrhagia	off-label use	386692008
Precocious puberty	off-label use	400179000
Endogenous Estrogen Production Test	off-label use
Female Hormonal Imbalance	off-label use
Hyperlipoproteinemia	contraindication	3744001	DOID:1168
Hypocalcemia	contraindication	5291005
Alcoholism	contraindication	7200002
Weight gain finding	contraindication	8943002
Impaired glucose tolerance	contraindication	9414007
Hypercholesterolemia	contraindication	13644009
Jaundice	contraindication	18165001
Myocardial infarction	contraindication	22298006	DOID:5844
Fibroadenosis of breast	contraindication	23260002	DOID:10352
Diplopia	contraindication	24982008
Retinal hemorrhage	contraindication	28998008
Ectopic pregnancy	contraindication	34801009	DOID:0060329
Depressive disorder	contraindication	35489007
Chloasma	contraindication	36209000
Migraine	contraindication	37796009	DOID:6364
Hypertensive disorder	contraindication	38341003	DOID:10763
Disorder of gallbladder	contraindication	39621005	DOID:0060262
Hypothyroidism	contraindication	40930008	DOID:1459
Mild pre-eclampsia	contraindication	41114007
Body fluid retention	contraindication	43498006
Thrombosis of retinal vein	contraindication	46085004
Humoral hypercalcemia of malignancy	contraindication	47709007
Chronic heart failure	contraindication	48447003
Dementia	contraindication	52448006
Hepatic porphyria	contraindication	55056006	DOID:3133
Systemic lupus erythematosus	contraindication	55464009	DOID:9074
Hyperlipidemia	contraindication	55822004	DOID:1168
Anorexia nervosa	contraindication	56882008	DOID:8689
Hepatic failure	contraindication	59927004
Cerebrovascular disease	contraindication	62914000	DOID:6713
Thrombophlebitis	contraindication	64156001	DOID:3875
Osteoporosis	contraindication	64859006	DOID:11476
Intermenstrual bleeding - irregular	contraindication	64996003
Diabetes mellitus	contraindication	73211009	DOID:9351
Hyperglycemia	contraindication	80394007	DOID:4195
Epilepsy	contraindication	84757009	DOID:1826
Breast lump	contraindication	89164003
Kidney disease	contraindication	90708001	DOID:557
Malignant neoplasm of liver	contraindication	93870000	DOID:3571
Uterine leiomyoma	contraindication	95315005	DOID:13223
Neoplasm of liver	contraindication	126851005	DOID:3571
Deep venous thrombosis	contraindication	128053003
Seizure disorder	contraindication	128613002
Incomplete miscarriage	contraindication	156072005
Bed-ridden	contraindication	160685001
Mammography abnormal	contraindication	168750009
Asthma	contraindication	195967001	DOID:2841
Cerebrovascular accident	contraindication	230690007
Pulmonary thromboembolism	contraindication	233935004
Thrombophilia	contraindication	234467004	DOID:2452
Disease of liver	contraindication	235856003	DOID:409
Chorea	contraindication	271700006
Pregnancy, function	contraindication	289908002
Hypertriglyceridemia	contraindication	302870006
Osteopenia	contraindication	312894000
Functional visual loss	contraindication	313165001
Malignant tumor of ovary	contraindication	363443007	DOID:2394
Thromboembolic disorder	contraindication	371039008
Cardiovascular event risk	contraindication	395112001
Disorder of coronary artery	contraindication	414024009
Obesity	contraindication	414916001	DOID:9970
Estrogen receptor positive tumor	contraindication	416053008
Porphyria	contraindication	418470004
Optic disc edema	contraindication	423341008	DOID:146
Family history of malignant neoplasm of breast	contraindication	429740004
Hypertensive urgency	contraindication	443482000
Carcinoma of female breast	contraindication	447782002
Smokes tobacco daily	contraindication	449868002
Predisposition to Thrombosis	contraindication

🐶 Veterinary Drug Use

Species	Use	Relation
Cattle	Estrus synchronization	Indication
Cattle	Induction of estrous cycles	Indication
Cattle	Synchronization of the return to estrus	Indication
Cattle	Advancement of first postpartum estrus	Indication
Cattle	Advancement of first pubertal estrus	Indication
Cattle	To increase rate of weight gain	Indication
Cattle	To improve feed efficiency	Indication
Sheep	Estrus induction	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Synovex C, Synovex S	Zoetis Inc.	2
Component E-C with Tylan, Component E-S with Tylan	Elanco US Inc.	3
EAZI-BREED CIDR Cattle Insert	Zoetis Inc.	1
EAZI-BREED CIDR Sheep Insert	Zoetis Inc.	1

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
1.78GM	MILPROSA	FERRING PHARMS INC	N201110	April 29, 2020	DISCN	SYSTEM	VAGINAL	10548904	Feb. 3, 2029	METHOD OF SUPPORTING EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED REPRODUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN
1.78GM	MILPROSA	FERRING PHARMS INC	N201110	April 29, 2020	DISCN	SYSTEM	VAGINAL	8580293	Jan. 21, 2030	METHOD OF SUPPORTING EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED REPRODUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	10206932	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	10675288	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	11033626	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	11793819	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	8846648	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	8846649	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	8933059	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	9114145	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	9114146	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	9301920	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	10206932	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	10675288	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	10806740	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	11033626	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	11103513	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	11793819	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	8846648	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	8846649	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	9006222	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	9114145	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	9114146	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	9301920	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG	PROGESTERONE	XIROMED	A218391	Sept. 19, 2025	RX	INSERT	VAGINAL	March 22, 2026	COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Progesterone receptor	Nuclear hormone receptor	P06401	PRGR_HUMAN	AGONIST	ED50	9.88	WOMBAT-PK	CHEMBL
Sigma non-opioid intracellular receptor 1	Membrane receptor	Q99720	SGMR1_HUMAN		Ki	6.59	CHEMBL
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		IC50	4.32	CHEMBL
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN		Ki	7.52	CHEMBL
Mineralocorticoid receptor	Nuclear hormone receptor	P08235	MCR_HUMAN		EC50	11	WOMBAT-PK
Estrogen receptor	Nuclear hormone receptor	P03372	ESR1_HUMAN				WOMBAT-PK
Androgen receptor	Nuclear hormone receptor	P10275	ANDR_HUMAN		Ki	8.07	CHEMBL
Corticosteroid-binding globulin	Secreted	P08185	CBG_HUMAN		Ki	7.38	CHEMBL
Sex hormone-binding globulin	Secreted	P04278	SHBG_HUMAN		Kd	6.94	CHEMBL
Sterol O-acyltransferase 1	Enzyme	P35610	SOAT1_HUMAN		IC50	4.77	CHEMBL
Fatty acid-binding protein, intestinal	Cytosolic other	P12104	FABPI_HUMAN		Ki	4.70	CHEMBL
Cation channel sperm-associated protein 1	Ion channel	Q8NEC5	CTSR1_HUMAN	ACTIVATOR	EC50	8.11	IUPHAR
Cation channel sperm-associated protein 2	Ion channel	Q96P56	CTSR2_HUMAN	ACTIVATOR	EC50	8.11	IUPHAR
Cation channel sperm-associated protein 3	Ion channel	Q86XQ3	CTSR3_HUMAN	ACTIVATOR	EC50	8.11	IUPHAR
Cation channel sperm-associated protein 4	Ion channel	Q7RTX7	CTSR4_HUMAN	ACTIVATOR	EC50	8.11	IUPHAR
Short transient receptor potential channel 5	Ion channel	Q9UL62	TRPC5_HUMAN	BLOCKER	IC50	5.30	IUPHAR
Sodium/nucleoside cotransporter 1	Transporter	O00337	S28A1_HUMAN		Ki	5.17	DRUG MATRIX
P2X purinoceptor 3	Ion channel	P56373	P2RX3_HUMAN		IC50	5.80	CHEMBL
Androgen receptor	Transcription factor		ANDR_RAT		IC50	5.81	CHEMBL
Fatty acid-binding protein, liver	Cytosolic other		FABPL_RAT		Ki	7.57	CHEMBL
Progesterone receptor	Transcription factor		Q690N0_BOVIN		Ki	8.44	DRUG MATRIX
Sigma non-opioid intracellular receptor 1	Membrane receptor		SGMR1_RAT		Kd	6.62	CHEMBL
Androgen receptor	Transcription factor		ANDR_MOUSE		IC50	7.43	CHEMBL
Progesterone receptor	Transcription factor		PRGR_RABIT		Ki	7.98	CHEMBL
C-8 sterol isomerase	Enzyme		ERG2_YEAST		Ki	5.35	CHEMBL
Sigma non-opioid intracellular receptor 1	Membrane other		SGMR1_CAVPO		Ki	6.18	CHEMBL
Steroid 5-alpha-reductase	Enzyme		S5A1_RAT S5A2_RAT		IC50	5.80	CHEMBL
Estrogen receptor	Transcription factor		ESR1_RAT ESR2_RAT		Kd	8.41	CHEMBL

External reference:

ID	Source
4017453	VUID
N0000145841	NUI
D00066	KEGG_DRUG
4017453	VANDF
C0033308	UMLSCUI
CHEBI:17026	CHEBI
STR	PDB_CHEM_ID
CHEMBL103	ChEMBL_ID
DB00396	DRUGBANK_ID
D011374	MESH_DESCRIPTOR_UI
5994	PUBCHEM_CID
2377	IUPHAR_LIGAND_ID
C003549	MESH_SUPPLEMENTAL_RECORD_UI
417	INN_ID
4G7DS2Q64Y	UNII
8727	RXNORM
2110	MMSL
53089	MMSL
5365	MMSL
d00550	MMSL
001290	NDDF
16683002	SNOMEDCT_US
50318003	SNOMEDCT_US
4G7DS2Q64Y	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Crinone	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6150	GEL	45 mg	VAGINAL	NDA	24 sections
Crinone	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6151	GEL	90 mg	VAGINAL	NDA	24 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0829	CAPSULE	100 mg	ORAL	ANDA	22 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0830	CAPSULE	200 mg	ORAL	ANDA	22 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9725	INJECTION	50 mg	INTRAMUSCULAR	ANDA	13 sections
PROGESTERONE	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3128	INJECTION, SOLUTION	50 mg	INTRAMUSCULAR	NDA	13 sections
PROGESTERONE	Human Prescription Drug Label	1	10888-7135	CAPSULE	100 mg	ORAL	ANDA	21 sections
PROGESTERONE	Human Prescription Drug Label	1	10888-7136	CAPSULE	200 mg	ORAL	ANDA	21 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	16714-157	CAPSULE	100 mg	ORAL	ANDA	23 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	16714-158	CAPSULE	200 mg	ORAL	ANDA	23 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	42291-784	CAPSULE	100 mg	ORAL	ANDA	25 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	42291-785	CAPSULE	200 mg	ORAL	ANDA	25 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	43598-349	CAPSULE	100 mg	ORAL	ANDA	21 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	43598-350	CAPSULE	200 mg	ORAL	ANDA	21 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	50090-2527	CAPSULE	100 mg	ORAL	ANDA	23 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3240	CAPSULE	100 mg	ORAL	NDA	24 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4656	CAPSULE	100 mg	ORAL	ANDA	23 sections
Progesterone	Human Prescription Drug Label	1	50090-5928	CAPSULE	100 mg	ORAL	ANDA	22 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	50090-6475	CAPSULE	100 mg	ORAL	ANDA	24 sections
PROGESTERONE	HUMAN PRESCRIPTION DRUG LABEL	1	50090-6771	CAPSULE	100 mg	ORAL	ANDA	23 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	50090-6835	CAPSULE	100 mg	ORAL	ANDA	24 sections
Bijuva	HUMAN PRESCRIPTION DRUG LABEL	2	50261-211	CAPSULE	100 mg	ORAL	NDA	31 sections
Bijuva	HUMAN PRESCRIPTION DRUG LABEL	2	50261-251	CAPSULE	100 mg	ORAL	NDA	31 sections
PROGESTERONE	HUMAN PRESCRIPTION DRUG LABEL	1	51407-980	CAPSULE	100 mg	ORAL	ANDA	22 sections
PROGESTERONE	HUMAN PRESCRIPTION DRUG LABEL	1	51407-981	CAPSULE	200 mg	ORAL	ANDA	22 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	51655-542	CAPSULE	100 mg	ORAL	ANDA	22 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	53002-2760	CAPSULE	200 mg	ORAL	ANDA	23 sections
Prometrium	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4230	CAPSULE	200 mg	ORAL	NDA	15 sections
Prometrium	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4250	CAPSULE	100 mg	ORAL	NDA	15 sections
Prochieve	HUMAN PRESCRIPTION DRUG LABEL	1	55056-0406	GEL	45 mg	VAGINAL	NDA	24 sections