Drospirenone: Side Effects, Uses & Monitoring
Gianvi is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.
- Data source
- FDA labeling via NIH DailyMed (label b61cdce5…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
No structured frequency data available in current labeling. Consult the official label.
Labeled uses (from FDA prescribing information)
Gianvi is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. Oral contraceptives are highly effective. Table II lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and contraceptive implants and IUDs, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Gianvi is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of Gianvi for PMDD when used for more than three menstrual cycles has not been evaluated. The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associate…
Conditions associated with Drospirenone in labeling
Acne Vulgaris
A common skin condition involving blocked hair follicles, pimples, blackheads, and cysts, most often during ad...
Anxiety Disorder
A group of mental health conditions characterized by excessive worry, fear, or nervousness that interferes wit...
Generalized Anxiety Disorder
Persistent, excessive worry about everyday situations that is difficult to control and interferes with daily l...
Premenstrual Syndrome
A combination of physical and emotional symptoms occurring in the days before menstruation....
Frequently Asked Questions
What is Drospirenone used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Drospirenone?
Current labeling for this ingredient does not include a structured frequency table that we can reproduce. Review the official label linked below.
Does Drospirenone require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Drospirenone.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.