SYEDA (drospirenone)
Syeda is a combined oral contraceptive containing both estrogen and progestin. It is used by women who want to prevent pregnancy. This medication helps patients manage their reproductive health by providing a reliable method of birth control.
How SYEDA Works
This medication works primarily by preventing the release of an egg from the ovaries, a process known as suppressing ovulation. It also causes changes to the cervical mucus to make it harder for sperm to reach an egg and alters the lining of the uterus to make implantation less likely.
Details
- Status
- Prescription
- First Approved
- 2011-03-28
- Routes
- ORAL-28
- Dosage Forms
- TABLET
SYEDA Approval History
What SYEDA Treats
1 indicationsSYEDA is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pregnancy prevention
SYEDA Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see CONTRAINDICATIONS ( 4 )]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information ...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see CONTRAINDICATIONS ( 4 )]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. • Women over 35 years old who smoke should not use drospirenone and ethinyl estradiol). ( 4 ) • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 )
SYEDA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SYEDA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07340190 | CDAK539A12102 2025-521000-22-00 | Ph 1 | not yet recruiting | 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 |
| NCT06345560 | 077766 | Ph 1, Ph 2 | recruiting | Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study |
| NCT07293728 | STUDY00028768 | Ph 4 | not yet recruiting | A Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia |
| NCT05461573 | CF113-303 | Ph 3 | completed | Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females |
| NCT05706753 | CR109284 2022-002828-12, 70033093THR1009 | Ph 1 | completed | A Study of Milvexian in Healthy Adult Females |
| NCT06039826 | 18533 J1I-MC-GZBV | Ph 1 | completed | A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SYEDA FDA Label Details
Indications & Usage
SYEDA is indicated for the treatment of Pregnancy prevention.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For t...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.