Drospirenone

Overview

Drospirenone is a synthetic progestin commonly found in the popular oral contraceptive, Yaz in combination with Ethinyl estradiol. Most recently, it was approved by both Health Canada and the FDA in combination with Estetrol as an oral contraceptive therapy. Aside from its contraceptive effects, drospirenone is used with estrogens to control acne and premenstrual dysphoric disorder (PMDD). Drospirenone has been the subject of widespread safety concern due to the possibility of an increased risk of venous thromboembolism associated with its use. In 2012, however, a safety statement by the FDA concluded that the increase in the risk of thromboembolism resulting from the use of drospirenone remains unclear, as studies regarding this risk are conflicting. Some studies have demonstrated a significantly increased risk and some demonstrating no risk of thromboembolic events. In its statement, the FDA has mentioned that increased risk of venous thromboembolism with oral contraceptives such as drospirenone exists but remains lower than the risk of this condition during pregnancy and during the postpartum period, and this should be considered when assessing potential risks of hormonal contraceptive use.

Indication

Drospirenone, in combination with ethinyl estradiol or estetrol, is indicated as an oral contraceptive for the prevention of pregnancy. In addition to its use for contraceptive effects, this combination is used to treat moderate acne vulgaris and the symptoms of premenstrual dysphoric disorder. The drug has approved indications for combination with estrogens for the treatment of menopause-associated symptoms, such as vasomotor symptoms and vulvovaginal atrophy. Drospirenone combined with estrogen may also may aid in the prevention of osteoporosis in women who have been post-menopausal for at least a year and are not candidates for other therapies. It can sometimes be found in preparations containing estrogen and folic acid for folic acid replenishment during oral contraception. When used for the treatment of acne vulgaris, drospirenone-containing contraceptives should only be used in women ≥14 years of age who have experienced menarche, desire oral contraception, and do not have any contraindications to oral contraceptives. Off-label uses for this drug include the treatment of menstrual irregularities, dysmenorrhea, hirsutism, and endometriosis.

Associated Conditions

Atrophy of vulva
Moderate to Severe Vasomotor Symptoms
Neural Tube Defects (NTDs)
Premenstrual Dysphoric Disorder (PMDD)
Vulvo Vaginal Atrophy
Moderate Acne vulgaris

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Prospective Evaluation on the Role Exerted by Hormonal Contraceptives on 24-h Blood Pressure. A Prospective Observational Study	2025/07/11	NCT07061093	N/A	Recruiting	Ospedale Policlinico San Martino
Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS?!	2024/09/23	NCT06608186	Phase 1	Completed	Ahmed Saad
Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study	2024/04/03	NCT06345586	Not Applicable	Recruiting	Chulalongkorn University
Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study	2024/04/03	NCT06345560	Phase 1	Recruiting	Chulalongkorn University
The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation	2024/03/22	NCT06324851	Phase 4	Completed	University of Palermo
Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib	2024/02/08	NCT06250205	Phase 1	Recruiting	NewAmsterdam Pharma
Evaluation of the Efficacy and Safety of Drospirenone in the Treatment of Adenomyosis	2023/12/18	NCT06174792	N/A	Not yet recruiting	University of Palermo
A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese	2023/09/15	NCT06039826	Phase 1	Completed	Eli Lilly and Company
Efficacy and Safety of Dingkundan Combined With Combination Oral Contraceptives in the Treatment of PCOS	2023/05/24	NCT05872425	Not Applicable	Completed	Guangdong Women and Children Hospital
A Study of Milvexian in Healthy Adult Females	2023/01/31	NCT05706753	Phase 1	Completed	Janssen Pharmaceutica N.V., Belgium

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Angeliq	Physicians Total Care, Inc.	54868-6184	ORAL	0.5 mg in 1 1	10/1/2010

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Drovelis	Gedeon Richter Plc.,Gyomroi ut 19-21,1103 Budapest,Hungary	Authorised	5/19/2021
Lydisilka	Estetra SPRL,Rue Saint-Georges 5,4000 Liege,Belgium	Authorised	5/19/2021

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
DROSPERA FILM-COATED TABLETS 3 MG/0.02 MG	Laboratorios León Farma S.A.	SIN14855P	TABLET, FILM COATED	3.00mg	9/22/2015
JASTINDA FILM COATED TABLETS 3MG/ 0.02MG	Laboratorios León Farma S.A	SIN14995P	TABLET, FILM COATED	3.00 mg	4/28/2016
SLINDA FILM-COATED TABLETS 4MG	Laboratorios León Farma S.A. (Primary Packager)	SIN16354P	TABLET, FILM COATED	4MG	11/1/2021
YAZ Film-coated Tablet	BAYER WEIMAR GMBH UND CO. KG, BAYER AG (Primary and Secondary packager)	SIN13584P	TABLET, FILM COATED	3.000 mg	12/15/2008
YASMIN TABLET	BAYER WEIMAR GMBH UND CO KG	SIN12334P	TABLET, FILM COATED	3 mg	6/25/2003
LIZA FILM-COATED TABLETS 3MG/0.03MG	Laboratorios León Farma S.A.	SIN14894P	TABLET, FILM COATED	3.00mg	11/13/2015
GVEZA FILM COATED TABLETS 3MG/ 0.03MG	Laboratorios León Farma S.A	SIN14996P	TABLET, FILM COATED	3.00 mg	4/28/2016

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
ELLANITE TABLETS 0.03MG/3MG	N/A	PRIMAL CHEMICAL COMPANY, LIMITED	N/A	N/A	6/25/2024
GVEZA TABLETS 3MG/0.03MG	N/A	Lotus Pharmaceutical HK Limited	N/A	N/A	8/15/2016

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
BROOKLYNN drospirenone/ethinyloestradiol 3 mg/30 microgram tablet blister composite pack	219080	Alphapharm Pty Ltd	Medicine	A	5/24/2022
YELENA drospirenone 3 mg and ethinylestradiol 30 microgram film-coated tablet blister pack	195219	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/3/2013
APO-DROSPIRENONE/EE 3/20 drospirenone 3 mg and ethinylestradiol 20 microgram film-coated tablet blister pack	200630	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/15/2013
PETIBELLE ethinylestradiol 30 microgram/ drospirenone 3 mg film coated tablet blister pack	226240	Bayer Australia Ltd	Medicine	A	8/4/2014
LUCINDA drospirenone 4mg tablet blister pack	427710	Lupin Australia Pty Limited	Medicine	A	10/31/2024
YVETTE drospirenone 3mg / ethinylestradiol 20 micrograms (as betadex clathrate) tablet blister pack	226243	Bayer Australia Ltd	Medicine	A	8/4/2014
ZAIDA 3/30 drospirenone/ethinyloestradiol 3 mg/30 microgram tablet blister composite pack	219082	Alphapharm Pty Ltd	Medicine	A	5/24/2022
APO-DROSPIRENONE/EE 3/30 drospirenone 3 mg and ethinylestradiol 30 microgram film-coated tablet blister pack	195217	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/3/2013
ROSIE ethinylestradiol/drospirenone 20 microgram/3 mg tablet blister pack	407771	Lupin Australia Pty Limited	Medicine	A	9/14/2023
YASMIN ethinylestradiol 30 micrograms / drospirenone 3 mg film coated tablet blister pack	226238	Bayer Australia Ltd	Medicine	A	8/4/2014

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
YASMIN 21	Bayer Inc	02261723	Tablet - Oral	3 MG	12/22/2004
QISMETTE 21	LUPIN LIMITED	02416506	Tablet - Oral	3.0 MG	N/A
YAZ	Bayer Inc	02321157	Tablet - Oral	3 MG	1/6/2009
MYA	Apotex Inc	02415380	Tablet - Oral	3.00 MG	5/20/2014
YASMIN PLUS	Bayer Inc	02442744	Tablet - Oral	3.0 MG	N/A
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS 21	Mylan Pharmaceuticals ULC	02424452	Tablet - Oral	3 MG	N/A
ZARAH 21	Cobalt Pharmaceuticals Company	02385058	Tablet - Oral	3 MG	6/4/2013
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS 28	Mylan Pharmaceuticals ULC	02424460	Tablet - Oral	3 MG	N/A
YASMIN 28	Bayer Inc	02261731	Tablet - Oral	3 MG	12/22/2004
ANGELIQ	Bayer Inc	02268825	Tablet - Oral	1.0 MG	10/20/2008

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ANTINELLE DIARIO 0,02 mg/3 mg COMPRIMIDOS CON PELICULA EFG	Kern Pharma S.L.	76080	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
CLEODETTE DIARIO 0,02 MG/3 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG	Aurovitas Spain, S.A.U.	77123	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
YAZ 3 mg / 0,02 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Bayer Hispania S.L.	70093	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
DRETINELLE DIARIO 0.02 mg/3 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Theramex Ireland Limited	72035	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ETINILESTRADIOL/DROSPIRENONA EXELTIS 0,02 MG/3 MG COMPRIMIDOS RECUBIERTOS CON PELICULA (24+4) EFG	Exeltis Healthcare S.L.	78405	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
DROSPIRENONA/ETINILESTRADIOL ARISTO 3 MG/0,02 MG COMPRIMIDOS EFG	Aristo Pharma Iberia S.L.	80228	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ETINILESTRADIOL/DROSPIRENONA DIARIO STADA 0,03 mg/3 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorio Stada S.L.	76059	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
AIDRAELLE DIARIO 3 MG/0,02 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Cinfa S.A.	78878	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
AIDRAELLE 3 MG/0,02 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Cinfa S.A.	78877	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ETINILESTRADIOL/DROSPIRENONA DIARIO STADA 0,02 mg/3 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorio Stada S.L.	76056	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

AI-Powered Research

Premium Access