drospirenone

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Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.10 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.12 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	76 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Property	Description	Value	Confidence	Similarity
kinase-safety-class	ACVR2B,AXL,BRAF,CAMK2D,CDK5,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,NTRK2,PDK1,PDK2,PDK4,PRKDC	15
kinase-selectivity-class	EIF2AK3,GRK2	2
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pld-class	Phospholipidosis risk class (1 = positive, 0 = negative)	1	High	1

Date	Agency	Company
May 19, 2021	EMA	Gedeon Richter Plc; Estetra SPRL
May 23, 2019	FDA	EXELTIS USA INC
July 23, 2010	PMDA	Bayer Yakuhin, Ltd.

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
Pregnancy on oral contraceptive	122.40	26.91	21	1839	1094	90625493
Pulmonary embolism	79.39	26.91	43	1817	130777	90495810
Deep vein thrombosis	52.42	26.91	29	1831	91591	90534996
Intermenstrual bleeding	46.49	26.91	14	1846	9209	90617378
Meningioma	45.11	26.91	12	1848	5059	90621528
Hepatic cytolysis	36.34	26.91	16	1844	30900	90595687
Food allergy	35.93	26.91	15	1845	25463	90601124
Depressive symptom	35.37	26.91	10	1850	5275	90621312
Abortion spontaneous	30.58	26.91	17	1843	54039	90572548
Psychotic disorder	29.86	26.91	14	1846	31216	90595371
Idiopathic intracranial hypertension	29.61	26.91	8	1852	3573	90623014
Allergic reaction to excipient	29.52	26.91	6	1854	782	90625805
Drug interaction	27.49	26.91	31	1829	276422	90350165
Oesophagitis	27.18	26.91	11	1849	17238	90609349

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
Pregnancy on oral contraceptive	98.21	30.45	16	1508	912	110586863
Pulmonary embolism	59.85	30.45	37	1487	214437	110373338
Deep vein thrombosis	46.40	30.45	27	1497	139860	110447915
Food allergy	45.34	30.45	15	1509	19933	110567842
Depressive symptom	34.72	30.45	10	1514	8404	110579371
Idiopathic intracranial hypertension	31.99	30.45	8	1516	3944	110583831
Allergic reaction to excipient	31.83	30.45	6	1518	793	110586982
Hepatic cytolysis	30.59	30.45	15	1509	55038	110532737

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drospirenone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products:

Source	Code	Description
ATC	G03AA12	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations
ATC	G03AA18	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations
ATC	G03AC10	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens
ATC	G03FA17	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	M0447349	Progesterone Congeners
MeSH PA	D000451	Mineralocorticoid Receptor Antagonists
MeSH PA	D004232	Diuretics
MeSH PA	D006727	Hormone Antagonists
FDA EPC	N0000175602	Progestin
CHEBI has role	CHEBI:49323	contraceptive drug
CHEBI has role	CHEBI:50844	aldosterone antagonist
CHEBI has role	CHEBI:59826	progestin

Disease	Relation	SNOMED_ID	DOID
Premenstrual dysphoric disorder	indication	596004
Contraception	indication	13197004
Atrophic vaginitis	indication	52441000
Acne vulgaris	indication	88616000
Menopausal flushing	indication	198436008
Atrophic vulva	indication	248861000	DOID:14275
Dysmenorrhea	indication	266599000
Controlled ovarian stimulation	indication	732970000
Polycystic ovaries	off-label use	69878008
Hyperlipoproteinemia	contraindication	3744001	DOID:1168
Hypocalcemia	contraindication	5291005
Hypercholesterolemia	contraindication	13644009
Hyperkalemia	contraindication	14140009
Myocardial infarction	contraindication	22298006	DOID:5844
Diplopia	contraindication	24982008
Retinal hemorrhage	contraindication	28998008
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
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
Acute nephropathy	contraindication	58574008
Thrombophlebitis	contraindication	64156001	DOID:3875
Intermenstrual bleeding - irregular	contraindication	64996003
Diabetes mellitus	contraindication	73211009	DOID:9351
Epilepsy	contraindication	84757009	DOID:1826
Breast lump	contraindication	89164003
Kidney disease	contraindication	90708001	DOID:557
Uterine leiomyoma	contraindication	95315005	DOID:13223
Deep venous thrombosis	contraindication	128053003
Seizure disorder	contraindication	128613002
Endometriosis	contraindication	129103003
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
Endometrial carcinoma	contraindication	254878006	DOID:2871
Chorea	contraindication	271700006
Pregnancy, function	contraindication	289908002
Hypertriglyceridemia	contraindication	302870006
Functional visual loss	contraindication	313165001
Malignant tumor of ovary	contraindication	363443007	DOID:2394
Thromboembolic disorder	contraindication	371039008
Adrenal cortical hypofunction	contraindication	386584007	DOID:10493
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

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
3MG;14.2MG	NEXTSTELLIS	MAYNE PHARMA	N214154	April 15, 2021	RX	TABLET	ORAL	7732430	Jan. 15, 2028	USE BY FEMALES OF REPRODUCTIVE POTENTIAL TO PREVENT PREGNANCY
3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	BEYAZ	BAYER HLTHCARE	N022532	Sept. 24, 2010	RX	TABLET	ORAL	11617751	July 17, 2030	PREVENTION OF PREGNANCY
3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	BEYAZ	BAYER HLTHCARE	N022532	Sept. 24, 2010	RX	TABLET	ORAL	11617751	July 17, 2030	RAISE FOLATE LEVELS IN WOMEN WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION FOR THE PURPOSE OF REDUCING THE RISK OF A NEURAL TUBE DEFECT IN A PREGNANCY
3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	BEYAZ	BAYER HLTHCARE	N022532	Sept. 24, 2010	RX	TABLET	ORAL	11617751	July 17, 2030	TREATMENT OF MODERATE ACNE VULGARIS IN WOMEN AT LEAST 14 YEARS OF AGE IF THE PATIENT DESIRES AN ORAL CONTRACEPTIVE FOR BIRTH CONTROL
3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	BEYAZ	BAYER HLTHCARE	N022532	Sept. 24, 2010	RX	TABLET	ORAL	11617751	July 17, 2030	TREATMENT OF MOOD CHANGES AND/OR ANXIETY AS SYMPTOMS OF PREMENSTRUAL DYSPHORIC DISORDER (PMDD) IN WOMEN WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION
3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	SAFYRAL	BAYER HLTHCARE	N022574	Dec. 16, 2010	RX	TABLET	ORAL	11617751	July 17, 2030	PREVENTION OF PREGNANCY
3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	SAFYRAL	BAYER HLTHCARE	N022574	Dec. 16, 2010	RX	TABLET	ORAL	11617751	July 17, 2030	RAISE FOLATE LEVELS IN WOMEN WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION FOR THE PURPOSE OF REDUCING THE RISK OF A NEURAL TUBE DEFECT IN A PREGNANCY
4MG	SLYND	EXELTIS USA INC	N211367	May 23, 2019	RX	TABLET	ORAL	10179140	June 28, 2031	PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
4MG	SLYND	EXELTIS USA INC	N211367	May 23, 2019	RX	TABLET	ORAL	10603281	June 28, 2031	PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
4MG	SLYND	EXELTIS USA INC	N211367	May 23, 2019	RX	TABLET	ORAL	10849857	June 28, 2031	PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
4MG	SLYND	EXELTIS USA INC	N211367	May 23, 2019	RX	TABLET	ORAL	11413249	June 28, 2031	PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
4MG	SLYND	EXELTIS USA INC	N211367	May 23, 2019	RX	TABLET	ORAL	11951213	June 28, 2031	PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
4MG	SLYND	EXELTIS USA INC	N211367	May 23, 2019	RX	TABLET	ORAL	12090231	June 28, 2031	PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
4MG	SLYND	EXELTIS USA INC	N211367	May 23, 2019	RX	TABLET	ORAL	9603860	June 28, 2031	PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
3.5MG	DROSPIRENONE	EXELTIS USA INC	N216285	June 29, 2022	DISCN	TABLET, CHEWABLE	ORAL	10179140	June 28, 2031	PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
3.5MG	DROSPIRENONE	EXELTIS USA INC	N216285	June 29, 2022	DISCN	TABLET, CHEWABLE	ORAL	10603281	June 28, 2031	PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
3.5MG	DROSPIRENONE	EXELTIS USA INC	N216285	June 29, 2022	DISCN	TABLET, CHEWABLE	ORAL	10849857	June 28, 2031	PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
3.5MG	DROSPIRENONE	EXELTIS USA INC	N216285	June 29, 2022	DISCN	TABLET, CHEWABLE	ORAL	11413249	June 28, 2031	PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
3.5MG	DROSPIRENONE	EXELTIS USA INC	N216285	June 29, 2022	DISCN	TABLET, CHEWABLE	ORAL	11951213	June 28, 2031	PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
3.5MG	DROSPIRENONE	EXELTIS USA INC	N216285	June 29, 2022	DISCN	TABLET, CHEWABLE	ORAL	12090231	June 28, 2031	PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
3.5MG	DROSPIRENONE	EXELTIS USA INC	N216285	June 29, 2022	DISCN	TABLET, CHEWABLE	ORAL	9603860	June 28, 2031	PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
3MG;14.2MG	NEXTSTELLIS	MAYNE PHARMA	N214154	April 15, 2021	RX	TABLET	ORAL	12427114	June 17, 2036	USE BY FEMALES OF REPRODUCTIVE POTENTIAL TO PREVENT PREGNANCY
3MG;14.2MG	NEXTSTELLIS	MAYNE PHARMA	N214154	April 15, 2021	RX	TABLET	ORAL	12233074	Feb. 9, 2043	USE BY FEMALES OF REPRODUCTIVE POTENTIAL TO PREVENT PREGNANCY
3MG;14.2MG	NEXTSTELLIS	MAYNE PHARMA	N214154	April 15, 2021	RX	TABLET	ORAL	12458649	Oct. 1, 2043	USE BY FEMALES OF REPRODUCTIVE POTENTIAL TO PREVENT PREGNANCY

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Mineralocorticoid receptor	Nuclear hormone receptor	P08235	MCR_HUMAN	ANTAGONIST	IC50	10.50	WOMBAT-PK	CHEMBL
Progesterone receptor	Nuclear hormone receptor	P06401	PRGR_HUMAN	AGONIST	EC50	10.50	WOMBAT-PK	CHEMBL
Androgen receptor	Nuclear hormone receptor	P10275	ANDR_HUMAN		IC50	8.50	WOMBAT-PK

ID	Source
4021271	VUID
N0000179010	NUI
D03917	KEGG_DRUG
4021271	VANDF
C0043822	UMLSCUI
CHEBI:50838	CHEBI
CHEMBL1509	ChEMBL_ID
DB01395	DRUGBANK_ID
C035144	MESH_SUPPLEMENTAL_RECORD_UI
68873	PUBCHEM_CID
2874	IUPHAR_LIGAND_ID
6519	INN_ID
N295J34A25	UNII
11636	RXNORM
16073	MMSL
d04759	MMSL
009133	NDDF
395275003	SNOMEDCT_US
410919000	SNOMEDCT_US
N295J34A25	INXIGHT DRUGS

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Angeliq	HUMAN PRESCRIPTION DRUG LABEL	2	50419-482	TABLET, FILM COATED	0.25 mg	ORAL	NDA	34 sections
Angeliq	HUMAN PRESCRIPTION DRUG LABEL	2	50419-483	TABLET, FILM COATED	0.50 mg	ORAL	NDA	34 sections
Angeliq	HUMAN PRESCRIPTION DRUG LABEL	2	54868-6184	TABLET, FILM COATED	0.50 mg	ORAL	NDA	24 sections