What are the most common side effects of DROSPIRENONE?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for DROSPIRENONE. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is DROSPIRENONE the same as drospirenone?

drospirenone is a brand name for DROSPIRENONE. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

DROSPIRENONE

Q: What is DROSPIRENONE used for?

DROSPIRENONE (brand name drospirenone) is a Other indicated for 1 INDICATIONS AND USAGE Drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet is a combination of drospirenone, a progestin and ethinyl estradiol.

Q: How does DROSPIRENONE work?

DROSPIRENONE works through the following mechanism: 12.1 MECHANISM OF ACTION COCs lower the risk of becoming pregnant primarily by suppressing ovulation..

Other

Brand names: drospirenone

Oral

Mechanism of Action

12.1 MECHANISM OF ACTION COCs lower the risk of becoming pregnant primarily by suppressing ovulation.

Indications

1 INDICATIONS AND USAGE Drospirenone

ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet is a combination of drospirenone

a progestin and ethinyl estradiol

an estrogen containing a folate

anxiety or tension

affective lability

Contraindications

• 4 CONTRAINDICATIONS Drospirenone
• if over age 35 [see Boxed Warning and Warnings And Precautions ( 5.1 )] Have deep vein thrombosis or pulmonary embolism
• subacute bacterial endocarditis with valvular disease
• or history of
• breast cancer

FDA Warnings

5 WARNINGS AND PRECAUTIONS Vascular risks : Stop drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets if a thrombotic event occurs
1 ) COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins
Before initiating drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE
03 mg ethinyl estradiol (that is, Yasmin ® ), DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins

Known Side Effects

5 documented side effects by frequency

Anxiety

1-10%

Nausea

0.1-1%

Abdominal Pain

0.1-1%

Shortness of Breath

0.1-1%

Vomiting

0.1-1%

Community Discussions

No community discussions found for DROSPIRENONE yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → DROSPIRENONE openFDA label JSON → DROSPIRENONE FAERS adverse-event reports → DROSPIRENONE ClinicalTrials.gov → completed Phase 2+ trials of DROSPIRENONE

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Formulations

Dosage Forms

Tablet

Route

Oral