Drospirenone

SLYND progestin-only oral contraceptive lowers the risk of becoming pregnant primarily by suppressing ovulation.

• SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy. SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy.

• SLYND is contraindicated in females with the following conditions: Renal impairment [see Warnings and Precautions (5.1) and Use in Specific Populations (8.7) ] Adrenal insufficiency [see Warnings and Precautions (5.1) ] Presence or history of cervical cancer or progestin sensitive cancers [see Warnings and Precautions (5.4) ] Liver tumors, benign or malignant, or hepatic impairment [see Warnings and Precautions (5.5) and Use in Specific Populations (8.6) ] Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8) ] Renal impairment ( 4 ) Adrenal insufficiency ( 4 ) Presence or history of progestin sensitive cancers ( 4 ) Liver tumors, benign or malignant, or hepatic impairment ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 )contraindicated

Take one tablet taken daily for 28 days; one white active tablet daily during the first 24 days and one green inactive tablet daily during the 4 following days. ( 2 ) 2.1 How to Use SLYND SLYND is dispensed in a blister card. SLYND should be started using a Day 1 start. Table 1 Instructions for Starting or Switching SLYND Starting SLYND in females with no current use of hormonal contraception (Day 1 Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: • SLYND active tablets are white (Day 1 to Day 24). • SLYND inert tablets are green (Day 25 to Day 28). Day 1 Start: • Take first white active tablet on the first day of menses. • Take subsequent white active tablets once daily at the same time each day for a total of 24 days. • Take one green inert tablet daily for 4 days and at the same time of day that active tablets were taken. • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet). Switching from another contraceptive method to SLYND Start SLYND: A Combined Oral Contraceptive (COC) On the day when the new pack of the previous COC would have started. Transdermal Patch On the day when next application would have been scheduled. Vaginal ring On the day when next insertion would have been scheduled. Injection On the day when next injection would have been scheduled.

Hyperkalemia: Check serum potassium levels during the first treatment cycle in females receiving daily, long-term treatment for chronic conditions of diseases with medications that may increase serum potassium concentrations. ( 5.1 ) Thromboembolic disorders: Discontinue SLYND if a thromboembolic event occurs. ( 5.2 ) Bone loss: It is unknown if SLYND may cause a clinically relevant loss of bone mineral density. ( 5.3 ) Liver Disease: Discontinue use if jaundice or acute or chronic disturbances of liver function develop. ( 5.5 ) Ectopic pregnancy: Be alert to the possibility of ectopic pregnancy in females who become pregnant or complain of lower abdominal pain while on SLYND. ( 5.6 ) Risk of Hyperglycemia in Patients with Diabetes: Patients with diabetes may be at greater risk of hyperglycemia and may require additional medication adjustments or monitoring. ( 5.7 ) Bleeding Irregularities and Amenorrhea: May cause irregular bleeding or amenorrhea. Evaluate for other causes, such as pregnancy, if irregular bleeding or amenorrhea persists. ( 5.8 ) 5.1 Hyperkalemia SLYND contains drospirenone, a progestin, which has anti-mineralocorticoid activity, including the potential for hyperkalemia in high-risk females, comparable to a 25 mg dose of spironolactone. SLYND is contraindicated in females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment, and adrenal insufficiency).

The following clinically significant adverse reactions are described elsewhere in other sections of the labeling: Hyperkalemia [see Warnings and Precautions (5.1) ] Bleeding Irregularities and Amenorrhea [see Warnings and Precautions (5.8) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect the exposure of SLYND in females of reproductive potential desiring to prevent pregnancy based on four clinical studies including Study CF111/303 [see Clinical Studies (14) ] . The mean time of SLYND exposure ranged from 197 to 328 days. The demographic profile for the pooled study data was: mean age 28 years; mean BMI 25 kg/m 2 ; racial distribution was 83% White; 14% Black; 1% Asian and 2% Other.

Pregnancy: Discontinue SLYND if pregnancy occurs ( 8.1 ) 8.1 Pregnancy Risk Summary Based on epidemiologic studies and meta-analyses, there is little or no increased risk of birth defects in the children of females who inadvertently use oral progestins during early pregnancy ( See Data ). Discontinue SLYND if pregnancy occurs, because there is no reason to use hormonal contraceptives during pregnancy In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. Data Human Data Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following maternal use of oral progestins before conception or during early pregnancy. 8.2 Lactation Risk Summary Negligible amounts of drospirenone are excreted in the breast milk (see Data ) . Thus, at therapeutic doses of SLYND, no effects on breastfed newborns/infants are anticipated. In general, no adverse effects have been found on milk production or on the health, growth, or development of the infant with use of progestin-only pills (POPs). Human Data After daily administration of 4 mg SLYND tablets, the average DRSP concentration in breast milk over a 24-hour period is 5.6 ng/mL.

Metabolism

Absorption The pharmacokinetics of oral drospirenone is dose-proportional following single doses ranging from 1-10 mg. Maximum concentrations (C max ) of drospirenone in plasma of about 27 ng/ml are reached at about 2-6 hours after single ingestion of SLYND.

There have been no reports of serious deleterious effects from overdosage of SLYND. Symptoms that may occur include nausea, vomiting, and vaginal bleeding. There are no antidotes and treatment should be to provide symptomatic support. Drospirenone is a spironolactone analogue which has anti-mineralocorticoid properties. Therefore, serum potassium and sodium, and evidence of metabolic acidosis, should be monitored in cases of overdose.

• May 11, 2001NDANDA021098Bayer Hlthcare
• Sep 28, 2005NDANDA021355Bayer Hlthcare
• Mar 16, 2006NDANDA021676Bayer Hlthcare
• Sep 24, 2010NDANDA022532Bayer Hlthcare
• Dec 16, 2010NDANDA022574Bayer Hlthcare
• Mar 28, 2011ANDAANDA090114Xiromed
• May 23, 2019NDANDA211367Exeltis Usa Inc
• Apr 15, 2021NDANDA214154Mayne Pharma

1. 1Pain13,18425%
2. 2Injury10,92421%
3. 3Pulmonary Embolism9,51718%
4. 4Deep Vein Thrombosis8,52016%
5. 5Anxiety7,19614%
6. 6Emotional Distress6,49813%
7. 7Cholecystitis Chronic5,57411%
8. 8Cholelithiasis4,1508.0%
9. 9Gallbladder Disorder4,0827.9%
10. 10General Physical Health Deterioration3,3376.4%
11. 11Nausea3,3066.4%
12. 12Abdominal Pain2,9265.7%
13. 13Dyspnoea2,5014.8%
14. 14Anhedonia2,2864.4%
15. 15Vomiting2,1774.2%

The 10 most recently updated of 165 ClinicalTrials.gov registrations naming Drospirenone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Drug-drug Interaction Study of Vorasidenib and a Combined Oral Contraceptive in Healthy Female Participants
  Completed · Phase 1 · Interventional · 28 enrolled · Institut de Recherches Internationales Servier (I.R.I.S.)
  NCT07235774updated 2026-05-12
• Arterial Vascular Effects of Estetrol-drospirenone Combined Oral Contraceptive Pill
  Not yet recruiting · Phase 3 · Interventional · 98 enrolled · Dr. Hang Wun Raymond Li
  NCT07536763updated 2026-04-27
• LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women
  Active not recruiting · Phase 4 · Interventional · 1,536 enrolled · Insud Pharma
  NCT05303636updated 2026-04-09
• A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies
  Not yet recruiting · Phase 1 · Interventional · 24 enrolled · Novartis Pharmaceuticals
  NCT07340190updated 2026-04-02
• Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants
  Completed · Phase 1 · Interventional · 74 enrolled · Vertex Pharmaceuticals Incorporated
  NCT07074327updated 2026-03-30
• Anxiety and Depression in Adolescent PCOS
  Completed · Interventional · 42 enrolled · Ege University
  NCT07127458updated 2026-03-25
• Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study
  Recruiting · Phase 1 · Phase 2 · Interventional · 16 enrolled · Chulalongkorn University
  NCT06345560updated 2026-03-19
• Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study
  Recruiting · Interventional · 16 enrolled · Chulalongkorn University
  NCT06345586updated 2026-03-18
• Oral Contraceptive Pills Versus Levonorgestrel-Releasing Intrauterine System for Niche-Related Abnormal Uterine Bleeding
  Completed · Interventional · 166 enrolled · Benha University
  NCT07229209updated 2026-02-20
• Effect of Drospirenone-Ethinyl Estradiol (20microgram vs 30 Microgram) on Free Androgen Index in PCOS
  Completed · Interventional · 60 enrolled · Mst.Sumyara Khatun
  NCT07318337updated 2026-01-09

Frequently asked questions

How does Drospirenone work?

SLYND progestin-only oral contraceptive lowers the risk of becoming pregnant primarily by suppressing ovulation.

What is Drospirenone used for?

According to FDA labeling, Drospirenone carries indications including: SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy. SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Drospirenone?

Drospirenone is classified as Progestogens, Progestin, Progestational Hormone Receptor Agonists, Decreased Embryonic Implantation, Inhibit Ovulation.

What are the contraindications for Drospirenone?

Drospirenone labeling lists contraindications including: SLYND is contraindicated in females with the following conditions: Renal impairment [see Warnings and Precautions (5.1) and Use in Specific Populations (8.7) ] Adrenal insufficiency [see Warnings and Precautions (5.1) ] Presence or history of cervical cancer or progestin sensitive cancers [see Warnings and Precautions (5.4) ] Liver tumors, benign or malignant, or hepatic impairment [see Warnings and Precautions (5.5) and Use in Specific Populations (8.6) ] Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8) ] Renal impairment ( 4 ) Adrenal insufficiency ( 4 ) Presence or history of progestin sensitive cancers ( 4 ) Liver tumors, benign or malignant, or hepatic impairment ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ). Always consult the full prescribing information and a clinician.